Leger diktet opp resultater (forbes.com 12.2.2008)

Amerikanske advokater undersøker forsøk som sikret lisens for Astrazenecas platehemmende legemiddel (BMJ 2013;347:f6727 ( November 2013)

Lilly setter "profitt foran forbrukerens anliggende", sa Dr. Gueriguian på slutten av sitt fire timers vitnemål. (nytimes.com 8.3.2008)

- Svikt hos FDA gir kriminelle adgang til godkjenningsprosessen (pharmatimes.com 15.2.2008)

FDA har ikke i tilstrekkelig grad utestengt mennesker og farmasøytiske firmaer dømt for kriminalitet, ifølge rapport
(kaisernetwork.org 12.2.2008)

Er GSK (GlaxoSmithKline) skyldig i bedrageri? Edtorial (Leder) (Lancet 2004;363:1919 (12.06.2004))

Hemmeligholdelse av publikasjonen om negative forsøk for selektive serotoninreopptakshemmere (SSRI) hos barn (...) er mer enn bare et spørsmål om “forvirring, manipulasjon, og institusjonell svikt”. Det er kriminalitet. (Lancet. 2004;363:2087)

Senator stiller spørsmål om GlaxoSmithKlines (GSK) bivirkningsinformasjon (finance.senate.gov)

Et rettslig grunnlag for legemiddelsikkerhet (BMJ 2008;336 (15 March))

The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity Opinion by Dr. David Graham (globalresearch.ca 19.11.2006)

Avklaring i retten er viktig fordi store uoppklarte forbrytelser har lett for å utvikle seg til samfunnssår som ikke vil gro.
(Lederartikkel - Aftenposten 18.9.2005)

1463 days to nothing - the GlaxoSmithKline Criminal Investigation (scientific-misconduct.blogspot.com 7.10.2007)

Psykiater anklaget for svindel i Seroxat-forsøk (dailycomet.com 14.6.2007)

- Svikt hos FDA gir kriminelle adgang til godkjenningsprosessen

FDA “failures allowing criminals into drug approval process (- Svikt hos FDA gir kriminelle adgang til godkjenningsprosessen)
pharmatimes.com 15.2.2008
Manglende handling hos den amerikanske legemiddelkontrollen (US Food and Drug Administration) har økt risikoen for at kriminelle opererer i, og undergraver kontrollen av legemiddelprosessen, er Kongressen blitt advart om. (Failure to act by the US Food and Drug Administration has increased the risk that criminals are operating in, and undermining, the drug regulatory process, Congress has been warned.)

Etaten har hverken vilje eller myndighet til å utelukke firmaer eller enkeltpersoner som er dømt for forbrytelser som bestikkelser, svindel, forfalskning, falsk vitneforklaring eller utpressing, ifølge en rapport utarbeidet for representant Joe Barton, rangerende (republikaner) medlem av House Committee on Energy and Commerce. (...) (The agency has neither the will nor the authority to debar companies or individuals convicted of crimes such as bribery, fraud, perjury, blackmail or extortion, according to a report prepared for Representative Joe Barton, ranking (Republican) member of the House Committee on Energy and Commerce.)

(Anm: Legemiddelindustrien (Big Pharma) (mintankesmie.no).)

(Anm: Forskning og ressurser (mintankesmie.no).)

(Anm: Fri tilgang til forskningsresultater? (forskningsdata) (mintankesmie.no).)

(Anm: The hidden side of clinical trials | Sile Lane | TEDxMadrid (youtube.com).)

(Anm: Recommendations to improve adverse event reporting in clinical trial publications: a joint pharmaceutical industry/journal editor perspective. BMJ 2016;355:i5078 (Published 03 October 2016).)

(Anm: Hvilke store legemiddelfirmaer gir forskning og utvikling (R&D) (FoU) høyest prioritet? (Which big biopharma companies put R&D as their top priority?) Ikke overraskende for alle som følger dette temaet, markedsføringsutgifter har en tendens til å være mye høyere enn FoU-budsjetter i denne bransjen.) (endpts.com 18.7.2016 (ENDPOINTS).)

(Anm: Statlig legemiddelkontroll (Statens legemiddelverk etc.) (mintankesmie.no).)

(Anm: Statlig hvitvasking av legemiddelinformasjon (Tidsskr Nor Legeforen 2010; 130:368 (25.2.2010).)

- Vanlige magesyrehemmere (syrepumpehemmere) knyttet til høyere risiko for død. (- Resultatene legges til en voksende liste over alvorlige helseproblemer knyttet til bruk av PPI, hvorav noen inkluderer nyreskader, Clostridium difficile-infeksjoner, beinbrudd hos personer med osteoporose og demens.)

(Anm: - Vanlige magesyrehemmere (syrepumpehemmere) knyttet til høyere risiko for død. Bruk av protonpumpehemmere (PPI) - en klasse legemidler tatt av millioner for å behandle halsbrann og redusere magesyre - er knyttet til en høyere risiko for tidlig død. (- Resultatene legges til en voksende liste over alvorlige helseproblemer knyttet til bruk av PPI, hvorav noen inkluderer nyreskader, Clostridium difficile-infeksjoner, beinbrudd hos personer med osteoporose og demens.) (- Kan øke risikoen for vevskader som skyldes oksidativ stress og telomerer som forkortes i celler. (medicalnewstoday.com 4.7.2017).)

(Anm: Protonpumpehemmere (proton pump inhibitors (PPIs) (syrepumpehemmere) (magesyrehemmere) (syrenøytraliserende midler (antacida)). (mintankesmie.no).)

(Anm: Bivirkninger (legemiddelinduserte organskader og sykdommer) (mintankesmie.no).)

- Lundbeck-rival dykker 40 pct efter dødsfald i Parkinsons-studier. (- Ifølge nyhedsbureauet havde selskabet observeret 7 tilfælde af sepsis, også kaldet blodforgiftning, med 5 dødsfald til følge på tværs af en række mellem- og senfasestudier med kandidaten.) (- Studierne med tozadenant vil fortsætte, men Acorda meddeler, at man nu vil øge overvågningen af patienternes blodtal i studierne.)

(Anm: Lundbeck-rival dykker 40 pct efter dødsfald i Parkinsons-studier. Et amerikansk selskab, der ligesom danske Lundbeck udvikler lægemidler mod Parkinsons sygdom, har set sin aktiepris falde med omkring 40 pct. onsdag, efter man meldte om fem dødsfald i kliniske studier med en lægemiddelkandidat. Det amerikanske biotekselskab Acorda Therapeutics meddelte onsdag, at flere forsøgspersoner er gået bort i kliniske studier med en lægemiddelkandidat mod Parkinsons sygdom.Det skriver Reuters.De kliniske problemer, som sendte selskabets aktiepris ned med små 40 pct. til 17 dollars stykket, skete i et fase 3-studie med kandidaten tozadenant. Ifølge nyhedsbureauet havde selskabet observeret 7 tilfælde af sepsis, også kaldet blodforgiftning, med 5 dødsfald til følge på tværs af en række mellem- og senfasestudier med kandidaten. Studierne med tozadenant vil fortsætte, men Acorda meddeler, at man nu vil øge overvågningen af patienternes blodtal i studierne. (medwatch.dk 16.11.2017).)

(Anm: Acorda reports five deaths in Parkinson's trial, shares plunge. (…) Four of the sepsis cases were associated with agranulocytosis - the absence of white blood cells. “Investors will hold a more distressed view of the drug’s odds of success and commercial potential as a byproduct of the update today,” Leerink Research analyst Paul Matteis said. Six patients died during the mid-stage trial but there was no suspicion at the time that these cases were related to the drug, Acorda Chief Executive Ron Cohen told Reuters. (reuters.com 15.11.2017).)

- Forskning bliver farlig, når de negative resultater glemmes.

(Anm: Forskning bliver farlig, når de negative resultater glemmes. (…) Nyt dansk studie viser problemet. (...) For få negative resultater leder til falske konklusioner. (…) Manglende negative resultater har kostet liv. (…) Vores model viser, at vi er nødt til at få publiceret mindst 20 procent af de negative resultater, der produceres inden for hvert forskningsfelt, hvis vi skal undgå at lave falske antagelser om videnskabelig fakta. (videnskab.dk 5.1.2017).)

(Anm: Fremstående celecoxib-forsker innrømmer fabrikasjon av data i 21 artikler. Prominent celecoxib researcher admits fabricating data in 21 articles. BMJ 2009;338:b966 (9 March).)

(Anm: Hvorfor begår forskere uredelighet? (Why do researchers commit misconduct?) (…) I alle disse tilfellene observerte vi at forskere som arbeider i land hvor publikasjonene er motivert av pengebonuser har større risiko for uredelighet eller skjevhet. (In all these cases, we observed that researchers that work in countries in which publications are incentivized with cash-bonuses are at greater risk from misconduct or bias.) (retractionwatch.com 14.4.2017).)

(Anm: Legemiddelindustriens fortjeneste var nesten det dobbelte av utgifter til forskning og utvikling (FoU-utgifter) i 2013, 2014 og 2015. (Pharmaceutical Industry Profits Are Nearly Double R&D Costs in 2013, 2014 and 2015) (…) En primær unnskyldning som legemiddelindustrien bruker for «prisøkning» er de høye kostnadene for forskning og utvikling (FoU) som disse firmaene betaler for å få nye legemidler på markedet. (citizen.org 27.3.2017).)

- Dette skjoldet av patenter beskytter verdens bestselgende legemiddel.

(Anm: Dette skjoldet av patenter beskytter verdens bestselgende legemiddel. (- Produktet med 16 milliarder dollar i årsomsetning. (...) - Det har dessuten vært tilgjengelig i nærmere 15 år. (…) Den virkelige utfordringen var den tilsynelatende ugjennomtrengelige festningen av patenter som AbbVie metodisk har bygget rundt sin verdsatte pengemaskin. (…) Humira, som står for mer enn 60 prosent av AbbVies inntekter har en listepris på mer enn 50 000 dollar per pasient. (bloomberg.com 7.9.2017).)

(Anm: Habilitet (integritet) (mintankesmie.no).)

(Anm: Interessekonflikter, bestikkelser og korrupsjon (mintankesmie.no).)

(Anm: Gratis lunch, legemidler, grådighetskultur og korrupsjon (mintankesmie.no).)

- Medicinal-firmaer betaler selv for at få lægemidler undersøgt, så resultatet bliver mere positivt.

(Anm: Medicinal-firmaer betaler selv for at få lægemidler undersøgt, så resultatet bliver mere positivt. Medicinalindustrien betaler ofte selv, når nye lægemidler skal undersøges, før de bliver godkendt. Forsøgenes resultater er langt oftere positive end ved uafhængig forskning, viser et nyt dansk studie. »Vi har et problem«, siger lægen bag studiet. (…) De spilleregler, der er sat op internationalt i forhold til lægemiddelgodkendelse, har skabt et system, hvor et privat firma blot skal dokumentere, at deres nye lægemiddel er en anelse bedre end placebo eller standardbehandling. (nrk.no 6.3.2017).)

(Anm: Myten om mediers åpenhet. Hvorfor er virkelig fordomsfri og frisinnet debatt uvanlig? Hvorfor så få nye, uavhengige meningsytrere? Hvorfor møter mediene dem dels med motstand, dels med taushet? (aftenposten.no 7.9.2006).)

(Anm: Er det en reproduserbarhetskrise i vitenskapelig forskning? (Is there a reproducibility crisis in science?) (…) Nyere studier, som undersøkte en rekke publiserte legemiddelstudier, klarte å gjenskape resultatene for mindre enn 25 % av dem - og tilsvarende resultater er blitt funnet i andre vitenskapelige disipliner. Hvordan bekjemper vi denne krisen for vitenskapelig ikke-reproduserbarhet? (ed.ted.com).)

(Anm: Spinn i randomiserte kontrollerte studier (RCT) på angstlegemidler (antidepressiva) med et positivt opprinnelig resultat: en sammenligning av bekymringer uttrykt av den amerikanske legemiddelkontrollen FDA og den publiserte litteratur. (Spin in RCTs of anxiety medication with a positive primary outcome: a comparison of concerns expressed by the US FDA and in the published literature.) BMJ Open. 2017 Mar 29;7(3):e012886.)

- LEGEMIDDELPENGER – FDA er avhengig av industrifinansiering; penger kommer «festet med strikk»

(Anm: LEGEMIDDELPENGER – FDA er avhengig av industrifinansiering; penger kommer «festet med strikk» (DRUG MONEY. FDA Depends on Industry Funding; Money Comes with “Strings Attached”) (pogo.org 1.12.2016).)

(Anm: LEGEMIDDELPENGER - I FDA-møter er "pasientstemmene" ofte finansiert av legemiddelfirmaer (DRUG MONEY - In FDA Meetings, "Voice" of the Patient Often Funded by Drug Companies) (pogo.org 3.12.2016).)

(Anm: Recommendations to improve adverse event reporting in clinical trial publications: a joint pharmaceutical industry/journal editor perspective. BMJ 2016;355:i5078 (Published 03 October 2016).)

(Anm: - Hadde medisinerne på et tidligere tidspunkt hatt et evolusjonært perspektiv på sin medisinering, ville vi ikke vært i den kritiske situasjon vi er kommet i med hensyn til resistens. (aftenposten.no 22.8.2016).)

(Anm: Antibiotika kan gi flere kroniske sykdommer. (…) Folkehelseinstituttet: – Faren er underkommunisert. – Advarslene er høyst betimelige, sier lege og seniorforsker Merete Eggesbø ved Folkehelseinstituttet. (…) Ifølge Blaser viser ny forskning at det er en sammenheng mellom endringen av den naturlige tarmfloraen vår og utvikling av nye sykdommer som fedme, diabetes, astma,(...) Advarslene er høyst betimelige, sier lege og seniorforsker Merete Eggesbø ved Folkehelseinstituttet. (…) Ifølge Blaser viser ny forskning at det er en sammenheng mellom endringen av den naturlige tarmfloraen vår og utvikling av nye sykdommer som fedme, diabetes, astma, allergi, autisme og mageinfeksjoner. (nrk.no 30.10.2016).)

(Anm: Researchers explore link between gut microbiome and nutrition in autism spectrum disorder. (…) Sharon Donovan, a professor of nutrition at the University of Illinois explains that researchers have started to look at more specific disease states and the microbiome. "We are starting to see links with autism, obesity, diabetes, cardiovascular disease, and almost every disease that is looked at. (news-medical.net 28.4.2017).)

(Anm: Researchers discover new mechanism that causes chronic intestinal inflammation. Researchers at the University Medical Center of Johannes Gutenberg University Mainz and the German Research Center for Environmental Health, Helmholtz Zentrum München have discovered that too much of the oncogene Bcl-3 leads to chronic intestinal diseases. They describe in Nature Communications exactly how it throws the immune system off-balance. Chronic intestinal disorders such as ulcerative colitis and Crohn's disease are caused by the body's own immune defense system. (news-medical.net 28.5.2017).)

(Anm: Forsiktighet kreves ved samtidig forskrivning av antibiotika med psykofarmaka hos eldre pasienter. (…) Antibiotika har flere legemiddelinteraksjoner med psykofarmaka som kan føre til bivirkninger eller behandlingssvikt og betydelig øke kostnadene for behandlinger. (dgnews.docguide.com 3.4.2017).)

(Anm: Antibiotika associeras med högre risk för tarmcancer. (…) Det här är första studien som visar på sambandet mellan antibiotikaanvändning och utveckling av adenom i tjock- och ändtarmen. Studien publiceras i den vetenskapliga tidskriften Gut. (…) Resultatet visade att långvarig antibiotikaanvändning tidigare i livet, i åldern 20 till 59 år, hade samband med diagnostiserade adenom. (lakemedelsvarlden.se 5.4.2017.)

(Anm: For mange retningslinjer for behandlinger er skrevet av eksperter med finansielle konflikter, viser studien. (statnews.com 22.8.2016).)

- Mange kliniske studier på barn forblir upubliserte eller uferdige.

(Anm: Mange kliniske studier på barn forblir upubliserte eller uferdige. (Many pediatric clinical trials go unpublished or unfinished.) (- Selv om ulike statlige lover ble utformet for å fremme kliniske studier for å teste produkter på barn blir en bemerkelsesverdig stor mengde forskning enten ikke publisert eller ikke fullført, ifølge en ny studie.) (statnews.com 4.8.2016).)

(Anm: Alvorlige bivirkninger skjules helt lovlig. Lægemiddelvirksomhederne tegner ikke altid et sandfærdigt billede af den medicin, de har udviklet - hverken over for myndighederne eller i de videnskabelige tidsskrifter. (videnskab.dk 25.1.2011).)

(Anm: Manisk svitsj forårsaket av antidepressiva: en sammenfattende sammenlignende gjennomgang av randomiserte kontrollerte studier og observasjonsstudier Manic switches induced by antidepressants: an umbrella review comparing randomized controlled trials and observational studies.(...) Conclusion. Our results highlight an underestimation of the rates of manic switch under antidepressants in RCTs compared to the rates observed in observational studies. Acta Psychiatrica Scandinavica 2016 (First published: 23 November 2016).)

(Anm: Markant flere bivirkninger i upublicerede kliniske studier. (…) Den mediane procentdel af offentliggjort dokumenter med information om bivirkninger var 46 pct., sammenlignet med 95 pct. i de tilsvarende, upublicerede dokumenter. (dagenspharma.dk 23.9.2016).)

(Anm: Facing questions on patient deaths, Aurinia shares crater in wake of lupus study (endpts.com 15.8.2016).)

(Anm: 13 deaths in Aurinia’s lupus drug trial despite hitting Phase II target. Canadian biotech Aurinia Pharmaceuticals has announced the topline Phase IIb trial results of its lupus nephritis (LN) treatment voclosporin, which revealed it had hit its primary endpoint, but this success was marred by the deaths of 13 trial participants. (pharmatimes.com 16.8.2016).)

- Spørsmål reist etter to dødsfall i AbbVie artrittstudie. AbbVies legemiddel mot reumatoid artritt, upadacitinib, er firmaets store plan for å håndtere det uunngåelige tap av salg for Humira, idet biotilsvarende begynner å ta markedsandeler.

(Anm: Questions raised after two deaths in AbbVie arthritis study. AbbVie’s rheumatoid arthritis drug, upadacitinib, is the company’s big plan to manage the inevitable loss of sales from Humira, as biosimilars begin to take chunks out of its market space. Only last month, the FDA approved Boehringer Ingelheim’s Cyltezo as a biosimilar to the drug – joining Amgen’s Amjevita. These plans have not been derailed but safety concerns are now going to dog the drug until further data is released after two patients were reported to have died whilst receiving upadacitinib in a Phase 3 trial. AbbVie reported that one patient in the 30mg dose group exhibited symptoms including fever and diarrhoea who then suffered heart failure. On the other patient, AbbVie could not give any reasons for the cause of death. (pharmafile.com 12.9.2017).)

- Fiona Godlee, editor in chief. Editor's Choice (Redaktørens valg). Hvorfor legemiddelgodkjenninger trenger bedre bevis (Why drug approval needs better evidence).

(Anm: Fiona Godlee, editor in chief. Editor's Choice (Redaktørens valg). Hvorfor legemiddelgodkjenninger trenger bedre bevis (Why drug approval needs better evidence). (…) Begge artiklene konkluderer at legemiddelkontrollen har et straksbehov for å kreve høyere standarder på bevis før og etter godkjenning. Økte kostnader for evaluering vil mer enn oppveies av lavere kostnader for ineffektive behandlinger, med bedre resultater og færre pasientskader. I mellomtiden trenger pasienter og deres leger å ha en ærlig og åpen kommunikasjon om den virkelige styrken på bevisene bak beslutninger om godkjenninger.) BMJ 2016;353:i3483 (Published 23 June 2016).)

(Anm: Folk dør av hemmelige bivirkninger. Over 90 prosent av alle bivirkninger fra legemidler rapporteres ikke - selv ikke dødelige og livstruende bivirkninger. (...) Slik kan du hjelpe andre: (bt.no 9.3.2015).)

(Anm: For mange retningslinjer for behandlinger er skrevet av eksperter med finansielle konflikter, viser studien. (statnews.com 22.8.2016).)

(Anm: Autisme: tidlig dødsrisiko en "skjult krise" (- Den ulikhet i utfall for autistiske mennesker vist i disse data er skammelige. Vi kan ikke akseptere en situasjon hvor mange autistiske mennesker aldri vil oppleve sin 40-årsdag.) (- Alle som er involvert i å støtte folk med autismespekteret fra regjeringen rett ned til lokalt helsepersonell har et ansvar for å stå opp og begynne å redde liv så snart som mulig.) (medicalnewstoday.com 21.3.2016).)

- Uheldige hendelser (bivirkninger) underrapporteres i målrettede terapiforsøk (studier)

AEs Are Underreported in Targeted Therapy Trials (Uheldige hendelser underrapporteres i målrettede terapiforsøk (studier))
clinicaloncology.com 16.2.2017
Copenhagen, Denmark— Mer enn halvparten av 81 studier som førte til godkjenning av en målrettet terapi ble vurdert å ikke være helt åpen om risikoen for bivirkninger (AES), ifølge en ny studie. Granskerne antydet at underrapportering av bivirkninger kan være hyppigere forekommende ved målrettede behandlinger enn konvensjonelle cytotoksiske kjemoterapier. (More than half of 81 trials leading to the approval of a targeted therapy were judged to not be fully transparent about the risk for adverse events (AEs), according to a new study. The investigators suggested that the underreporting of AEs might be a more frequent occurrence with targeted treatments than conventional cytotoxic chemotherapies.)

"Toksisitet for målrettede substanser og immunterapi er åpenbart forskjellig fra den toksisitet vi er vant til å observere og behandle ved kjemoterapi og det finnes enkelte toksisiske aspekter for disse nyere midler hvor det sannsynligvis er behov for mer informasjon," rapporterte Paolo Bossi, MD, onkolog/forsker ved Fondazione IRCCS ved Istituto Nazionale dei Tumori, i Milano. (“Toxicities of targeted agents and immunotherapy are obviously different from the toxicities we are used to observing and treating due to chemotherapy, and there are some aspects of the toxicities of these newer agents for which we probably need more information,” reported Paolo Bossi, MD, a research oncologist at the Fondazione IRCCS at Istituto Nazionale dei Tumori, in Milan.)

In this study, presented at the 2016 European Society for Medical Oncology Congress (abstract 320P), the published manuscripts on targeted therapy trials in a variety of solid malignancies, including lung, breast and colon, were scored for AE reporting with a 24-point rating tool developed by the Consolidated Standards of Reporting Trials (CONSORT) Group. The CONSORT initiative was specifically founded to establish standards for clinical trial methodology. (…)

(Anm: Uten obduksjoner begraver sykehusene feilene sine. (Without Autopsies, Hospitals Bury Their Mistakes) (…) Da Renee Royak-Schaler uventet kollapset og døde 22. mai beordret ingen obduksjon. (…) Diagnostiske feil, som studier viser er vanlig, forblir uoppdaget, og tillater at leger kan fortsette sin praksis på andre pasienter med en falsk følelse av trygghet. (…) Mulighetene for å lære om effektiviteten av medisinske behandlinger og progresjon av sykdommer går tapt. Unøyaktig informasjon ender opp i dødsattester, og undergraver påliteligheten for avgjørende helsestatistikk. (propublica.org 15.12.2011).)

(Anm: Legemiddelkonsulenter (sales representatives) (mintankesmie.no).)

(Anm: Legemiddelkonsulenter forteller leger lite om sideeffekter, ifølge studie. (Drug Reps Tell Docs Little of Side Effects: Survey) (Journal of General Internal Medicine 2013 (April).)

(Anm: Medisinske tidsskrifter og uavhengighet etc. (mintankesmie.no).)

- Amerikanske Merck har valgt at stoppe patientrekrutteringen til to senfasestudier med selskabets vigtigste kræftmiddel Keytruda for at undersøge flere dødsfald blandt forsøgspersonerne.

(Anm: Merck pauser kræftstudier efter dødsfald. Amerikanske Merck har valgt at stoppe patientrekrutteringen til to senfasestudier med selskabets vigtigste kræftmiddel Keytruda for at undersøge flere dødsfald blandt forsøgspersonerne. Dem amerikanske medicinalkoncern Merck, kendt som MSD i Europa, har valgt at stoppe patientrekrutteringen til to senfasestudier med kræfthåbet Keytruda, pembrolizumab. PD-1-hæmmeren bliver i de nu pausede forsøg testet mod blodkræft (mylematose), som også Genmabs Darzalex er rettet mod. (…) Immunterapien fra Merck bliver testet som kombinationsbehandling med Celgenes Pomalyst, pomalidomide, og Revlimid, lenalidomid. Keytruda er godkendt til behandling af lungekræft, blærekræft, fremskreden melanom og refraktær Hodgkins lymfom. (medwatch.dk 13.6.2017).)

- Mercks salg av Keytruda øker, men europeisk søknad er trukket.

(Anm: Mercks salg av Keytruda øker, men europeisk søknad er trukket. Merck Keytruda sales soar, but European application pulled. (Reuters) - Merck & Co on Friday said quarterly sales of its Keytruda cancer immunotherapy exceeded $1 billion for the first time, but it withdrew an application for European use of the drug in lung cancer, raising questions about future sales. Merck's shares, which fell 6 percent to close at $58.24, were down another 3 percent at $56.68 after hours. (reuters.com 28.10.2017).)

(Anm: Merck pulls Keytruda lung combo application in Europe (biopharmadive.com 30.10.2017).)

- Juno sagsøges for hemmeligholdt dødsfald. (- Ifølge anklageren solgte Bishop aktier for mere end 8,6 mio. dollars i selskabet i juni, hvilket er mere, end han solgte aktier for i selskabet i 2015. Efterfølgende, da dødsfaldet blev offentliggjort, faldt Junos aktier med mere end 30 pct.)

Juno sagsøges for hemmeligholdt dødsfald
medwatch.dk 19.8.2016
uno Therapeutics skjulte oplysninger om et dødsfald under et klinisk forsøg, hævder selskabets investorer i et sagsanlæg.

Det amerikanske biotekselskab Juno Therapeutics har i flere forstande en uheldig sag på nakken.

Selskabet er nemlig blevet sagsøgt i forbindelse med et dødsfald under et fase 2-studie med lægemiddelkandidaten JCAR015 mod akut lymfatisk leukæmi. Det skriver BioSpace.

Det er dog ikke dødsfaldet i maj måned, der i sig selv er baggrund for sagsanlægget. Junos CEO Hans Bishop er nemlig blevet sagsøgt, fordi anklageren på vegne af investorerne mener, at selskabet forsøgte at skjule dødsfaldet for netop investorerne - og det strider imod amerikansk lov.

Ifølge anklageren solgte Bishop aktier for mere end 8,6 mio. dollars i selskabet i juni, hvilket er mere, end han solgte aktier for i selskabet i 2015. Efterfølgende, da dødsfaldet blev offentliggjort, faldt Junos aktier med mere end 30 pct.

Studiet med JCAR015 blev midlertidigt stoppet, da yderligere to personer døde under behandling, og det skyldtes lige som ved første dødsfald hævelser i hjernen. I starten af juli blev studiet dog genoptaget, hvilket sendte aktierne op med 28 pct. (…)

(Anm: Juno and the FDA screwed up. People died. What now? (endpts.com 28.11.2016).)

(Anm: Trial of novel leukaemia drug is stopped for second time after two more deaths. BMJ 2016;355:i6376 (Published 25 November 2016).)

(Anm: Two more patients die as Juno’s lead CAR-T turns lethal again; trial halted. Juno’s lead CAR-T drug is killing more patients, and this time it may have reached the end of the clinical road. Four months after the biotech was forced to scramble to save the program in the wake of three patient deaths, Juno says that two more patients have died of cerebral edema out of only 12 more patients treated in the study. Juno has voluntarily put the study back on clinical hold and informed regulators at the FDA, who may not be so quick to allow this study to resume this time around. Juno’s stock $JUNO immediately cratered after trading was resumed, plunging 45%. (endpts.com 23.11.2016).)

(Anm: Could Toxicity Issues Topple CAR-T Cancer Therapies? There's no more promising area in cancer research right now than CAR-T immune therapies. Desperately ill cancer patients -- many with no other options -- are benefiting from these powerful cellular therapies that harness the power of the body's own immune system to fight the disease. The near-miraculous treatments have shown a 70%-80% rate of total remissions, but they still come with great risk. Just how dangerous the cutting edge of science is for both investors and patients was proved again last month when three patients died from brain swelling in a Juno Therapeutics (NASDAQ:JUNO) CAR-T trial. The FDA slapped a temporary hold on the mid-stage leukemia trial, and Juno's stock took a huge hit, (…) (finance.yahoo.com 27.2016).)

(Anm: Controversial patient deaths in CAR-T study spur a class action suit against Juno. Juno continues to feel the fallout from its painful, and very brief, trial hold for its lead CAR-T JCAR015. In a newly filed class action suit, investors say that they were purposefully misled by Juno executives, who kept quiet about the first suspicious patient death in May. (endpts.com 17.8.2016).)

(Anm: Deaths in Cancer Trials Remain Mystery for Promising Therapy. (…) The deaths are a reminder that an overactive immune system is linked to many serious conditions, such as lupus and rheumatoid arthritis. Doctors say side effects are part and parcel of the way CAR-T fights cancer -- by ratcheting up the body’s defenses. (…) Among the companies there will be the industry’s top players -- Juno Therapeutics Inc., Kite Pharma Inc. and Novartis AG. A key question concerns the risk of brain swelling, which happened to five leukemia patients in a Juno trial, who later died, as well as one in a Novartis study. (bloomberg.com 2.12.2016).)

(Anm: Finanschef beskyldt for insiderhandel med pharma-tips. (- Sanjay Valvani er anklaget for at have handlet på tips fra en tidligere ansat i den amerikanske FDA-myndighed, som bl.a. godkender lægemidler, samt for at sende informationerne videre til kollegaen Christopher Plaford. (medwatch.dk 16.6.2016).)

(Anm: Lederartikkel. Behov for lovregulering for å avsløre og stoppe medisinsk svindel. Det er stadig vanskeligere å ignorere behovet for et offentlig rettslig organ for uredelig forskning. (…) Det synes imidlertid rimelig å si at Storbritannia aldri har tatt problemet på alvor. (Editorials. Statutory regulation needed to expose and stop medical fraud. It’s increasingly hard to ignore the need for a statutory body for research misconduct. (…) It seems fair to say, however, that Britain has never taken the problem seriously.) BMJ 2016;352:i293 (Published 02 February 2016).)

(Anm: Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study. (…) Conclusions Devices approved first in the EU are associated with an increased risk of post-marketing safety alerts and recalls. Poor trial publication rates mean that patients and clinicians need greater regulatory transparency to make informed decisions about treatment. BMJ 2016;353:i3323 (Published 28 June 2016).)

(Anm: TEST UTVIKLET FOR Å OPPDAGE FARLIGE BIVIRKNINGER SLIK AT FÆRRE PASIENTER GIS UTRYGGE LEGEMIDLER (Test aims to detect dangerous side effects so that fewer patients are given unsafe drugs) (medicalnewstoday.com 19.12.2014).)

(Anm: The European Medicines Agency (EMA) (tidligere EMEA) (den europeiske legemiddelkontrollen) (mintankesmie.no).)

(Anm: Spøkelsesforfattere (ghostwriters) (mintankesmie.no).)

(Anm: Skiftet fra akademiske til kommersielle legemiddelnettverk (CRO - Kontraktsforskningsorganisasjoner) (mintankesmie.no).)

(Anm: Åpenhet om data (datatransparens) er den eneste måten (Data transparency is the only way) Editor's Choice - Fiona Godlee, editor in chief (BMJ 2016;352:i1261).)

(Anm: Legemidlene virker ikke: en moderne medisinsk skandale. Legene som forskriver legemidler vet ikke at de ikke virker som de er ment å gjøre. Det gjør heller ikke deres pasienter. Produsentene vet det veldig godt, men de forteller det ikke. (The drugs don't work: a modern medical scandal.) (guardian.co.uk 21.9.2012).)

(Anm: Are clinical drug trials more marketing than science? (ER KLINISKE LEGEMIDDELFORSØK MER MARKEDSFØRING ENN VITENSKAP?) (…) Based on what we found, marketing trials probably occur more often than I first thought. Perhaps, because clinicians who are involved in a company-sponsored clinical trial significantly increase their prescribing preferences for the sponsor’s drug, irrespective of international guidelines, which is deeply disturbing when you think about it. (blogs.biomedcentral.com 21.1.2016).)

(Anm: How to use rhetoric to get what you want - Camille A. Langston (ed.ted.com).)

(Anm: Forførende entusiasme: 40 års forskning på Dr. Fox-effekten. (Uniped 02 / 2016 (Volum 9).)

(Anm: Characterisation of trials where marketing purposes have been influential in study design: a descriptive study. (…) CONCLUSIONS: We reached consensus that a fifth of drug trials published in the highest impact general medical journals in 2011 had features that were suggestive of being designed for marketing purposes. Each of the marketing trials appeared to have a unique combination of features reported in the journal publications. Trials. 2016 Jan 21;17(1):31.)

(Anm: Antidepressant Fails Depressed HF Patients. —No impact on depression scores or clinical outcomes in double-blind trial (medpagetoday.com 30.6.2016).)

(Anm: Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012. (…) CONCLUSIONS: Trial disclosures for new drugs remain below legal and ethics standards, with wide variation in practices among drugs and their sponsors. Best practices are emerging. 2 of our 10 reviewed companies disclosed all trials and complied with legal disclosure requirements for their 2012 approved drugs. Ranking new drugs on transparency criteria may improve compliance with legal and ethics standards and the quality of medical knowledge. BMJ Open. 2015 Nov 12;5(11):e009758.)

(Anm: Lederartikkel. Behov for lovregulering for å avsløre og stoppe medisinsk svindel. Det er stadig vanskeligere å ignorere behovet for et offentlig rettslig organ for uredelig forskning. (…) Det synes imidlertid rimelig å si at Storbritannia aldri har tatt problemet på alvor. (Editorials. Statutory regulation needed to expose and stop medical fraud. It’s increasingly hard to ignore the need for a statutory body for research misconduct. (…) It seems fair to say, however, that Britain has never taken the problem seriously.) (BMJ 2016;352:i293 (Published 02 February 2016).)

(Anm:  Editorials. Richard Smith, chair of the board of trustees. Statutory regulation needed to expose and stop medical fraud. (…) Something is rotten in the state of British medicine and has been for a long time. Statutory regulation is needed. BMJ 2016;352:i293 (Published 02 February 2016).)

(Anm: Editor's Choice. Notes on three scandals. BMJ 2016;352:i674 (Published 04 February 2016).)

(Anm: Head To Head. Are clinical trials units essential for a successful trial? BMJ 2015;350:h2823  (Published 27 May 2015).)

(Anm: Novo Nordisk tager betalerne "meget nøje med i ed". Medicinalselskaber er i højere grad end tidligere nødt til at forholde sig til de amerikanske betalere, som bliver stadigt mere magtfulde. "Hvis vi ikke får fat i de rigtige patienter, så vil vores strategi kollapse på et tidspunkt," siger Jakob Riis, koncerndirektør, China, Pacific & Marketing i Novo Nordisk. (dagpharmatimes.com 15.9.2015).)

(Anm: Details of French trial must be released urgently, say UK experts. British specialists have called for further information to be made available urgently about a drug trial in France that has claimed one life and left another five volunteers in hospital, three with serious brain damage. BMJ 2016;352:i319 (Published 18 January 2016).)

- FDA har ikke i tilstrekkelig grad utestengt mennesker og farmasøytiske firmaer dømt for kriminalitet, ifølge rapport

FDA Has Not Appropriately Debarred Individuals, Pharmaceutical Companies Convicted of Crimes, Report Finds (FDA har ikke i tilstrekkelig grad utestengt mennesker og farmasøytiske firmaer dømt for kriminalitet, ifølge rapport)
kaisernetwork.org 12.2.2008
FDA has not appropriately debarred a number of individuals and pharmaceutical companies convicted of crimes from participation in the agency approval process for medications, according to a report presented on Monday by House Energy and Commerce Committee Republicans, Bloomberg/New York Times reports (Bloomberg/New York Times, 2/12). FDA for the past 15 years has had the authority to issue mandatory or permissive debarments, based on the severity of the crimes involved.

The report, drafted by Republican committee staff members, lists 40 individuals convicted of crimes between fiscal years 2003 and 2005 who they maintain FDA should have debarred. According to the report, FDA has debarred a total of 71 individuals but has taken such action against only 13 individuals in the past five years. FDA has never debarred a generic pharmaceutical company and does not have the authority to take such action against brand-name pharmaceutical or medical device companies, according to the report.

The report said, "It is doubtful that this is simply a matter of resources," as "other agencies have been able to start and complete debarments promptly." The report attributed the problem in part to the five-year period that FDA has to issue debarments after convictions. The report indicated that the five-year period might "give the agency an incentive to be lax," according to CongressDaily.

Committee ranking member Joe Barton (R-Texas) said, "This staff report shows in great detail the record of weaknesses in FDA's ability and authority to carry out its duties and to protect its own integrity." Barton has asked his staff to begin to draft legislation to address the problem, an aide said. In the event that FDA does not take action to address the problem, Barton said that he will seek to reduce the agency budget (Edney, CongressDaily, 2/12). (...)

(Anm: Legemiddelindustrien (Big Pharma) (mintankesmie.no).)

(Anm: USAs mest beundrede lovbryter. (America's Most Admired Lawbreaker ) I løpet av 20 år utviklet Johnson & Johnson et kraftig legemiddel, promoterte det ulovlig overfor barn og eldre, skjulte bivirkninger og tjente milliarder av dollar. Dette er innsidehistorien. (Over the course of 20 years, Johnson & Johnson created a powerful drug, promoted it illegally to children and the elderly, covered up the side effects and made billions of dollars. This is the inside story.) (huffingtonpost.com 8.10.2015).)

(Anm: Over 1,000 Chinese NDAs rejected due to 'fabricated or incomplete clinical trial data'. The China Food and Drug Administration (CFDA) has withdrawn 1,184 drug registration applications following a recent yearlong government investigation into clinical trials in the country. (…) The China Food and Drug Administration (CFDA) has withdrawn 1,184 drug registration applications following a recent yearlong government investigation into clinical trials in the country. (outsourcing-pharma.com 29.9.2016).)

(Anm: Deaths, accusations of insider trading and an early warning from Boehringer stir Hanmi controversy. (…) As Boehringer earlier acknowledged to me, there were “two cases of toxic epidermal necrolysis, one of them fatal, and one case of Stevens-Johnson-Syndrome in which the patient subsequently died due to disease progression and pneumonia.” (endpts.com 11.10.2016).)

(Anm: Tjenestemenn anklaget også firmaene for at de i markedsføringen av legemidler til barn hadde unnlatt å opplyse om at Risperdal (risperidone) kan føre til hormonelle ubalanser som kan føre til brystvevutvikling og infertilitet (barnløshet) hos gutter og jenter. I markedsføringen av legemidlet for behandling av eldre mennesker med demens hadde firmaet opprettet et salgsteam for omsorg for eldre, til tross for at data fra en studie finansiert av Janssen som viste at risperidon doblet risikoen for dødsfall blant eldre mennesker, ifølge statlige tjenestemenn. BMJ 2015;351:h7018 (Published 31 December 2015).)

(Anm: - Således ble bruk av antipsykotika knyttet til en doblet risiko for lungebetennelse hos pasienter med AD (Alzheimers sykdom), og til og med en høyere relativ risikoøkning (3,43 ganger) blant dem uten AD. (…) Resultatene indikerer at bruk antipsykotika er knyttet til en høyere risiko for lungebetennelse uavhengig av alder, anvendt studiedesign, behandlingsvarighet, valg av legemidler eller samtidige sykdommer. (dgnews.docguide.com 30.8.2016).)

(Anm: Among antidementia drugs, memantine is associated with the highest risk of pneumonia. A recent study from the University of Eastern Finland shows that among users of antidementia drugs, persons using memantine have the highest risk of pneumonia. The use of rivastigmine patches is associated with an increased risk as well. (medicalnewstoday.com 24.11.2016).)

(Anm: Publikum ønsker tøffere straffetiltak mot uansvarlig atferd i næringslivet. (- Resultatene viste en sterk offentlig bekymring for skjevhet i rettssystemet) (theconversation.com 25.7.2016).)

(Anm: Superrike skattesnytarar. (…) Denne verksemda vil ikkje ta slutt før dei som legg til rette for hemmeleghald og skatteunndraging – bankar, advokatar og rådgjevarar – opplever ein reell risiko for å bli straffa for å utføre slike tenester.) (dn.no 3.7.2017).)

(Anm: EU-kommissionen visste om VW-fusket. (- Misstankarna inom kommissionen väcktes till liv när dess experter insåg att luftkvaliteten i städer inte förbättrades som förväntat efter de strängare utsläppskraven för bilar som infördes 2007, enligt Der Spiegel.) (nyteknik.se 15.7.2016).)

(Anm: Volkswagen mistenkt for å ha villedet EUs investeringsbank. Volkswagen er mistenkt for å ha brukt et lån fra Den europeiske investeringsbanken (EIB) til å utvikle teknologi som åpnet for juks med utslippstester. Sjefen for den europeiske investeringsbanken (EIB) Werner Hoyer er skuffet over Volkswagen. (dn.no 2.8.2017).)

(Anm: VW-chef erkänner bedrägeri. En högt uppsatt chef på tyska Volkswagen (VW) i USA, inblandad i avgasskandalen, erkänner bedrägeri, meddelade en talesperson för domstolen i Detroit på tisdagen. (nyteknik.se 26.7.2017).)

(Anm: VW-topp sier seg skyldig – risikerer 169 år i fengsel. Den tidligere VW-toppen i USA, Oliver Schmidt, innrømmer å ha forsøkt å dekke over utslippsjukset. Nå risikerer han mange år bak murene. (tv2.no 28.7.2017).)

(Anm: Tidligere Volkswagen-ingeniør dømt til fengsel. En tidligere ingeniør i Volkswagen får 40 måneders fengsel etter Volkswagen-skandalen. (vg.no 25.8.2017).)

(Anm: Dieselskandalen truer tysk økonomi. Den tyske dieselskandalen utgjør en risiko for landets økonomi, opplyser Tysklands finansdepartement i en rapport mandag. Dieselskandalen oppsto for nesten to år siden, da det ble kjent at Volkswagen jukset med utslippstallene. Her monterer tyske arbeidere dieselmotorer på en Volkswagen-fabrikk i Chemnitz i Tyskland. (dn.no 21.8.2017).)

(Anm: -1200 vil dø av utslipp fra Volkswagens «juksebiler». Amerikanske forskere har undersøkt konsekvensene av utslippsjuks. (…) Det er forskere ved universitetet MIT i USA som har sett nærmere på konsekvensene av Volkswagens utslippsjuks. (dagbladet.no 3.3.2017).)

(Anm: Dieseljuks. Forskere har funnet den skjulte koden i juksebilene til Volkswagen. Gikk langt for å hindre at det var mulig å teste det virkelige utslippet. (…) Nå har de funnet svaret, gjemt i programvaren til bilene, melder University of California San Diego. (…) Resultatene er publisert i en rapport (PDF), som blir lagt frem frem under IEEE Symposium on Security and Privacy i San Francisco denne uken. Under vanlig bruk, slipper bilene ut inntil 40 ganger mer NOx enn tillatt. Utslippsavsløring: Skrur av eksosrensingen allerede ved 17 grader (tu.no 23.5.2017).)

(Anm: Research. The Volkswagen Emissions Scandal Could Shorten Thousands of Lives, Study Says (time.com 3.3.2017).)

(Anm: VW-sjef pågrepet i USA En høytstående sjef i Volkswagen i USA har i kjølvannet av dieselskandalen blitt pågrepet av FBI, mistenkt for bedrageri, ifølge The New York Times. Oliver Schmidt ble ifølge den amerikanske avisa pågrepet lørdag. (nrk.no 9.1.2017).)

(Anm: Volkswagen må betale 36 milliarder kroner etter utslippsjukset. (aftenposten.no 11.1.2017).)

(Anm: Volkswagen trolig spart for milliarder i USA. En dommer i USA har avvist et søksmål mot Volkswagen, noe som kan spare den tyske bilprodusenten for milliarder av dollar i utbetalinger. Avgjørelsen kan avskrekke en rekke amerikanske stater fra å saksøke Volkswagen etter utslippsskandalen som har fulgt bilprodusenten i nesten to år. Den føderale dommeren Charles Breyer avviste søksmålet fra delstaten Wyoming med henvisning til at den aktuelle forurensningsloven må reguleres sentralt og ikke av de amerikanske delstatene. (dn.no 1.9.2017).)

(Anm: Tysk avis: VW-sjefen godkjente dekkoperasjon. Martin Winterkorn, avgått konsernsjef i Volkswagen, godkjente en plan om å holde tilbake informasjon fra amerikanske myndigheter, skriver Bild. (e24.no 26.9.2016).)

(Anm: VW må betale 2,8 milliarder dollar i bot for dieseljuks. Beløpet tilsvarer over 24 milliarder kroner. (dagbladet.no 21.4.2017).)

(Anm: Lægemiddelstyrelsen slår hårdt ned på indisk fusk. For første gang har EMA valgt at gribe ind over for datafusk på baggrund af inspektørrapporter fra FDA og WHO. Lægemiddelstyrelsens nye direktør har spillet en markant rolle i processen, og kalder tilfældet ”usædvanligt groft”. Fremover bliver der et endnu stærkere samarbejde mellem de internationale parter. (medwatch.dk 8.8.2016).)

(Anm: Nobelprisvinner trekker seg fra Panama-gransking. (…) Begrunnelsen er at granskingen vanskeliggjøres av hemmelighold og manglende åpenhet.) (…) Pieth sier det blant annet finnes beviser for hvitvasking av penger fra barneprostitusjon i Panama-dokumentene. (dn.no 6.8.2016).)

(Anm: Margaret McCartney: Valgfri offentliggjøring av utbetalinger er meningsløst. (Margaret McCartney: Optional disclosure of payments is pointless.) (- Og åpenhet anskueliggjør problemene: bør de som mottar tusenvis av pund fra industrien som "påtenkte ledere" sitte i paneler for utarbeidelse av nasjonale retningslinjer eller hjelpe til med å stake ut regjeringens politikk?) BMJ 2016;354:i3692 (Published 01 July 2016).)

(Anm: For mange retningslinjer for behandlinger er skrevet av eksperter med finansielle konflikter, viser studien. (statnews.com 22.8.2016).)

(Anm: Naturlig at dette er offentlig. OUS-lege Elisabeth Gulowsen Celius samtykket til offentliggjøring av honorarer. Hun er kritisk til kolleger som ikke har gjort det samme. – Det kan reise spørsmål om det er bindinger som ikke tåler dagens lys. (dagensmedisin.no 12.8.2016).)

(Anm: Resultater publisert i JAMA Internal Medicine antyder at ett enkelt gratis måltid kan øke sannsynligheten for at en lege vil foreskrive et bestemt legemiddel. (Findings published by JAMA Internal Medicine suggest that even a single free meal can boost the likelihood a doctor will prescribe a certain drug) (online.wsj.com 20.6.2016).)

(Anm: FDAs rådgivere på opioider sparket grunnet bånd til industrien, ifølge AP. (FDA's advisers on opioids booted for ties to industry, AP learns. Having been buffeted by controversy over its approval of addictive opioid drugs, the FDA is calling on a panel of experts to help it sort through the thorny issue. But even before the new panel met, it has been tinged by controversy itself, dismissing four advisers because of perceived ties to drugmakers.) (fiercepharma.com 8.7.2016).)

(Anm: Offentliggjøring av verdioverføringer. Legemiddelindustrien offentliggjør i dag alle verdioverføringer til helsepersonell og helseforetak. (lmi.no 30.6.2016).)

(Anm: Leder. Disclosure UK: åpenhet (offentliggjøring) bør ikke lenger være valgfritt BMJ. (Editorials. Disclosure UK: transparency should no longer be an optional extra) BMJ 2016;354:i3730 (Published 06 July 2016).)

(Anm: Disclosure UKs nettsted gir en "illusjon av åpenhet", sier Goldacre (Disclosure UKs nettsted gir en "illusjon av åpenhet", sier Goldacre) (Disclosure UK website gives “illusion of transparency,” says Goldacre) BMJ 2016;354:i3760BMJ 2016; 354 (Published 06 July 2016).)

(Anm: Reporting of financial and non-financial conflicts of interest by authors of systematic reviews: a methodological survey. (…) Conclusions Although close to half of the published systematic reviews report that authors (typically many) have conflicts of interest, more than half report that they do not. Authors reported individual conflicts of interest more frequently than institutional and non-financial conflicts of interest. BMJ Open 2016;6:e011997.)

(Anm: - Legene som deklarerte de høyeste inntektene fra legemiddelfirmaer i Storbritannias nye database uttaler at åpenhet om utbetalingene bør være obligatorisk. (The doctors who declared the most earnings from drug companies in the United Kingdom’s new database have said that being transparent about payments should be mandatory.) BMJ 2016;354:i3716 (Published 04 July 2016).)

(Anm: Leger som mottar de største utbetalingene fra legemiddelfirmaer deklarerer dem ikke på nytt nettsted. (Doctors getting biggest payments from drug companies don’t declare them on new website. BMJ 2016;354:i3679 (Published 01 July 2016).)

(Anm: Association between payments from manufacturers of pharmaceuticals to physicians and regional prescribing: cross sectional ecological study. BMJ 2016;354:i4189 (Published 18 August 2016).)

(Anm: Medisinsk utstyr (mintankesmie.no).)

(Anm: Legemiddelprodusenter og medisinske utstyrsprodusenter betalte i fjor 6,5 milliarder dollar til leger og undervisningssykehus. (Drug and device makers paid $6.5 billion to docs and teaching hospitals last year.) (statnews.com 30.6.2016).)

(Anm: - Reseptbelagte legemidler blir sett på som velsignet av legemiddelkontrollen FDA, mens foreldre og barn oversvømmes av stadig mer aggressiv reklame fra legemiddelfirmaer med meldinger om at disse substansene er trygge, populære, og fordelaktige. (medicalnewstoday.com 27.3.2015).)

(Anm: Legemiddelreklame (legemiddelinformasjon) (mintankesmie.no).)

(Anm: Concerns over data manipulation lands Chinese API maker with US FDA Warning. The US FDA has hit cancer-drug API maker Yunnan Hande Bio-Tech with a warning letter citing concerns over potential manipulation of quality test data... (in-pharmatechnologist.com 22.4.2015).)

(Anm: Antidepressant drug trials criteria not generalizable (medicalnewstoday.com 13.8.2015).)

(Anm: Depression: study is first to confirm the value of "Socratic questioning" (medicalnewstoday.com 13.8.2015).)

(Anm: More clinical trials are succeeding for the first time in years. After years of declines, the pharmaceutical industry is experiencing a greater rate of success with its clinical trials in recent years, according to a new analysis. Between 2012 and 2014, more than 11 percent of clinical trials succeeded, which meant compounds being tested survived the arduous journey from the laboratory to the pharmacy counter. (…) Between 1996 and 1999, the cumulative success rate was 16.4 percent, but gradually began declining in subsequent years. From 2000 to 2003, 10.8 percent of trials succeeded before falling to 10 percent between 2004 and 2007, and then bottoming out at just 7.5 percent between 2008 and 2011. (statnews.com 13.6.2016).)

(Anm: The FDA has read the riot act to yet another Chinese drugmaker after finding it had been hiding batch test results that showed high peaks of out-of-spec readings. The FDA gave the drugmaker a 10-point action plan the agency wants it to follow if it expects to sell API in the U.S. (fiercepharma.com 16.8.2016).)

- Sykt system: Rekordbøter på 11 milliarder dollar avskrekker ikke legemiddelgiganter fra kriminalitet

Sick system: Record $11 bln fines do not deter pharma giants from crime (Sykt system: Rekordbøter på 11 milliarder dollar avskrekker ikke legemiddelgiganter fra kriminalitet)
rt.com 21.9.2012 (Russia Today)
Legemiddelfirmaer har fått rekordstore bøter på 11 milliarder dollar de siste tre årene for uetisk og ulovlig praksis. Men ledende forskere sier firmaene vil fortsette å bryte loven, de oppfatter bøter som "prisen for å gjøre forretninger." (Pharmaceutical companies have been fined a record $11 billion over the past 3 years for unethical and illegal practices. But leading researchers says companies will carry on breaking the law, regarding fines as “the cost of doing business.”)

Åtte av ti av de største legemiddelprodusentene i verden er blitt tatt i å bryte loven i denne perioden. Alt i alt har 26 helsefirmaer signert "corporate integrity agreements" med amerikanske myndigheter, en form for prøvetid etter alvorlig svindel. (­Eight out of 10 of the biggest pharmaceutical producers in the world have been caught breaking the law in this period. All in all 26 healthcare companies have signed “corporate integrity agreements” with US authorities, a form of probation following serious fraud.)

Deres ugjerninger varierer og omfatter dusinvis av bestselgende legemidler, men faller inn under flere vanlige typer. (...) (Their misdeeds are varied and cover dozens of best-selling drugs, but fall into several common types.)

(Anm: Pasientsikkerhet (rettssikkerhet) (mintankesmie.no).)

(Anm: Fri tilgang til forskningsresultater? (forskningsdata) (mintankesmie.no).)

(Anm: The hidden side of clinical trials | Sile Lane | TEDxMadrid (youtube.com).)

(Anm: Forvaltningsmakt og kunnskapspolitikk. Sammendrag. Helse- og omsorgsdepartementet benekter at de ønsker å styre forskninga i underliggende etater, og ser ingen problemer med at forskninga ligger under forvaltninga. Rus & Samfunn 05 / 2016 (Volum 9) Side: 33-35.)

(Anm: Frie forskere eller maktens lakeier? Abstrakt. Det går et skisma gjennom den samfunnsvitenskapelige rusforskningen. Ved første øyekast er det vanskelig å forstå hvorfor. Rus & Samfunn 05 / 2016 (Volum 9) Side: 36-40.)

(Anm: Nesten halvparten av alle studier som er gjennomført av store sponsorer i det siste tiåret er upublisert (Nearly half of all trials run by major sponsors in past decade are unpublished.) BMJ 2016;355:i5955 (Published 04 November 2016).)

(Anm: Who's not sharing their trial results? (trialstracker.ebmdatalab.net).)

(Anm: Transparency for patients: How much is too much? (pharmafile.com 11.10.2016).)

(Anm: Parlamentsmedlemmer hører at kliniske forsøk er byråkratiske, uklare, og forvirrende for forskere og pasienter. (…) "Det har vært en rekke kjente tilfeller hvor godkjente legemidler er basert på ufullstendig informasjon — og hvor den informasjonen som senere er stilt til rådighet har vist at legemidlet er ineffektivt eller faktisk skadelig.  (Clinical trials are bureaucratic, opaque, and offputting to researchers and patients, MPs hear.) BMJ 2013;346:f1711 (14 March 2013).)

(Anm: Double dip: doctors paid to advise, promote drug companies that fund their research. ProPublica. 25 March 2014.).)

(Anm: Forsker sår tvivl om baggrund for godkendelse af kræftmedicin. Kræftmidler, der er blevet godkendt på baggrund af surrogate endemål viser sig ofte ikke at forbedre overlevelsen. Det konkluderer en artikel i JAMA Internal Medicine. Fra 2008 til 2012 blev surrogateffektmål brugt som grundlag for FDA-godkendelse i 36 ud af 54 kræftlægemidler. Efter et gennemsnit på fire års opfølgning har det vist sig, at 31 af alle disse kræftlægemidler stadig havde ukendte effekter på den samlede overlevelse. Det fremgår af en artikel i JAMA Internal Medicine, som forfatterne Vinay Prasad, […] (dagenspharma.dk 22.10.2015).)

(Anm: Many cancer drugs recently approved in US do not improve overall survival, study finds. In recent years most cancer drug approvals by the US Food and Drug Administration have been made on the basis of a surrogate endpoint, such as tumour response rate or progression-free survival. When such approvals are made the agency typically advises or requires that post-approval studies be conducted to clarify the drug’s effect on overall survival. BMJ 2015;351:h5634 (Published 23 October 2015).)

(Anm: Forskningsresultater underdriver bivirkninger ved kemo. Kræftpatienter må forberede sig på alvorlige bivirkninger af den kemobehandling, de får, og i den virkelige verden ender de langt oftere på hospitalet, end hvad der fremgår af videnskabelige undersøgelser. Det viser en ny undersøgelse, der er offentliggjort i JAMA Oncology. Forskerne fandt ud af, at patienter med fremskreden lungekræft i den virkelige verden endte på hospitalet otte gange oftere end de patienter, som medvirkede i videnskabelige undersøgelser, som er kontrollerede og regulerede. Forskerne fandt også, at meget få undersøgelser i det hele taget beskriver, hvor […] (dagenspharma.dk 7.10.2015).)

(Anm: Reporting of clinical trial results by top academic centers remains poor. Dissemination of clinical trial results by leading academic medical centres in the United States remains poor, despite ethical obligations -- and sometimes statutory requirements -- to publish findings and report results in a timely manner, concludes a study in The BMJ this week. (sciencedaily.com 18.2.2016).)

(Anm: Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. (…) Conclusions Despite the ethical mandate and expressed values and mission of academic institutions, there is poor performance and noticeable variation in the dissemination of clinical trial results across leading academic medical centers. BMJ 2016;352:i637 (Published 17 February 2016).)

(Anm: Läkemedel stoppas på grund av misstänkt fusk. Godkännandet för fyra läkemedel återtas tillfälligt efter beslut av Läkemedelsverket. Beslutet har sin bakgrund i att företaget som utfört kliniska studier för produkterna misstänks ha fuskat med resultat. Produkterna är inte farliga för patienterna och ersättningsprodukter finns att tillgå. (lakemedelsverket.se 9.6.2016).)

- Med dette vedtaket forbys Lundbeck å benytte reklame som beskrevet over ved markedsføringen av legemiddelet Brintellix jf. legemiddelforskriften § 13-10 første ledd.

VEDTAK OM FORBUD MOT REKLAMEOPPLEGG BENYTTET DEN 12. NOVEMBER 2015 FOR BRINTELLIX
legemiddelverket.no 12.1.2016
Med dette vedtaket forbyr Statens legemiddelverk Lundbeck å benytte reklameopplegg lik det som ble benyttet i møte 12. november 2015 på Clarion Hotel i Stavanger ved markedsføring av legemidlene Brintellix jf. legemiddelforskriften § 13-10 første ledd.  
Rettslig grunnlag: Legemiddelforskriften § 13-3 første ledd, som bestemmer: Reklame for legemidler skal være nøktern og saklig. Den skal fremme rasjonell bruk i henhold til gjeldende forskrivningsregler. Reklamen må ikke gi et misvisende eller overdrevet bilde av et legemiddels egenskaper og medisinske verdi. Reklamen må ikke føre til bruk av legemidlet som ikke er medisinsk begrunnet. Reklamen skal samsvare med den spesielle preparatomtale som er godkjent av Statens legemiddelverk. (…)

Legemiddelverkets vurdering: Det er riktig at SPC i avsnitt 5.1 gjengir resultater fra studier som har undersøkt effekten av vortioksetin på psykologiske tester som DSST, UPSA, PDQ og CPFQ.  Når firmaet gir inntrykk av at Brintellix har en betydningsfull effekt på kognisjon som er uavhengig av den antidepressive effekten, er dette i strid med vurderingen legemiddelmyndighetene gjorde av studiene i forbindelse med godkjenningen av Brintellix i 2013 og også i strid med den vurderingen som ble gjort da avsnittet ble tatt inn i SPC fra 22. februar 2015.  

Selv om CHMP (jmf. Assessment Report EMA/CHMP/702417/2014) åpnet for en nøktern beskrivelse av resultater fra studier som omhandler kognisjon i SPC, legger EMA’s vurdering klare rammer for hvilken betydning Lundbeck kan gi dette i reklamesammenheng. 

Legemiddelverket mener reklamemøtet totalt sett ga et overdrevet bilde av legemidlets egenskaper og medisinske verdi ved å gi inntrykk av at  
- Brintellix har en betydningsfull effekt på kognisjon utover det som skyldes den antidepressive effekten. - Brintellix har en betydningsfull effekt på kognisjon som gjør at Brintellix i klinisk bruk er bedre enn andre antidepressiva. 

Etter Legemiddelverkets vurdering var reklamemøtet slik det er drøftet ovenfor derfor egnet til å gi et overdrevet bilde av Brintellix medisinske verdi. Møtet formidlet videre ikke opplysningene i avsnitt 5.1 om mulig effekt på sider ved kognisjon på en nøktern måte.

Reklamemøtet representerte derfor et brudd på legemiddelforskriften §13-3 som slår fast at reklame for legemidler skal være nøktern og saklig. Reklame skal fremme rasjonell bruk i henhold til gjeldende forskrivningsregler. Reklamen må ikke gi et misvisende eller overdrevent bilde av et legemiddels egenskaper og medisinske verdi. Reklamen må ikke føre til bruk av legemiddelet som ikke er medisinsk begrunnet. 

Med dette vedtaket forbys Lundbeck å benytte reklame som beskrevet over ved markedsføringen av legemiddelet Brintellix jf. legemiddelforskriften § 13-10 første ledd. (…)

(Anm: Lundbeck (mintankesmie.no).)

Lundbeck: Slaget er ikke tabt endnu
medwatch.dk 29.3.2016
Selvom de amerikanske myndigheder i nat meddelte, at de ikke vil give Lundbeck en udvidet indlægsseddel for depressionsmidlet Brintellix, kaster medicinalkoncernen ikke håndklædet i ringen af den grund. Nu går der en dialog i gang med FDA om, hvad der så skal til for at komme i mål med at få godkendt stoffets evner på de kognitive evner hos mennesker med svær depression. (…)

(Anm: Interessekonflikter, bestikkelser og korrupsjon (mintankesmie.no).)

(Anm: Når er et synspunkt en interessekonflikt? (When is a point of view a conflict of interest?) BMJ 2016;355:i6194 (Published 23 November 2016).)

(Anm: Høyresiden har størst mistillit til journalistikken. (…) Videre mente 63 prosent at journalister favoriserer kilder som mener det samme som dem. (aftenposten.no 13.2.2017).)

(Anm: Mina Ghabel Lunde, journalist. Når kilder også er venner. Pressen skal unngå bindinger som skaper usikkerhet om lojalitet. Da kan ikke journalister omgås sine kilder privat. (aftenposten.no 8.2.2017).)

(Anm: Ingen gratis lunsj for leger: Sponsede måltider knyttet til flere resepter (No free lunch for docs: Sponsored meals linked to more prescriptions) (mmm-online.com 20.6.2016).)

(Anm: Offentlig indkøber brugte usaglige argumenter i Lundbeck-opgør. Offentlige myndigheder skal tænke sig om, inden de går i retten mod medicinalkæmpen Lundbeck, for selskabet skaber arbejdpladser og finansierer forskning, advarer den offentlige indkøbsorganisation Amgros. Usagligt, lyder det fra eksperter. (medwatch.dk 29.3.2016).)

(Anm: Lundbeck får kurshug efter overraskende melding fra USA. Det koster aktionærerne fra morgenstunden, at Lundbeck ikke fik et ja fra FDA til at udvide indlægssedlen for depressionsmidlet Brintellix. (medwatch.dk 29.3.2016).)

(Anm: Amerikansk afvisning er en spand koldt vand i hovedet på Lundbeck. Det blev imod forventning et nej til Lundbecks Brintellix fra de amerikanske lægemiddelmyndigheder. Meget overraskende siger Sydbank-analytiker, og det vil komme til at koste. (medwatch.dk 29.3.2016).)

(Anm: FDA panel backs game-changing cognitive claim for Lundbeck antidepressant Brintellix.  Lundbeck is hoping that a new FDA label will turn its new antidepressant into a blockbuster in the making. An agency advisory panel backed Brintellix as a brainpower boost for people with depression. (fiercepharma.com 4.2.2016).)

BRIEF-Lundbeck and Takeda receive complete response letter by FDA for Brintellix (vortioxetine) sNDA
reuters.com 29.3.2016
Lundbeck :
* Says Lundbeck and Takeda receive complete response letter (CRL) by the U.S. Food and Drug Administration (FDA) for Brintellix (vortioxetine) supplemental new drug application (sNDA)
* FDA issued a CRL for sNDA to include new data in the clinical trials section of the U.S. label of Brintellix (vortioxetine) for treating certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD)
* Complete response letter does not apply to use of Brintellix in MDD
* Says Takeda and Lundbeck are disappointed with the response given that the U.S. FDA Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8 to 2 that Takeda and Lundbeck presented substantial evidence to support a claim of effectiveness for Brintellix in treating certain aspects of cognitive dysfunction in adults with MDD
* Parties look forward to reviewing the contents of the letter with the FDA to determine the appropriate path forward (…)

(Anm: Vortioxetine (Brintellix) Side Effects (depression.about.com).)

(Anm: Takeda renames antidepressant after name confusion leads to errors. (…) Takeda’s antidepressant Brintellix will be marketed as Trintellix beginning in June, after the Food and Drug administration approved a brand name change in order to avoid confusion with AstraZeneca’s blood thinner Brilinta. The change was prompted by safety concerns laid out in a July 2015 MedWatch alert from the FDA, which reported name confusion between the two drugs had led to prescribing errors. (biopharmadive.com 3.5.2016).)

(Anm: ‘Smart’ pillbox wins Takeda depression challenge. A ‘smart’ pillbox to improve medication adherence has won an open innovation competition for depression. Takeda launched the Open Innovation in Depression Care Crowd Challenge to crowdsource innovations for Multiple Depressive Disorder (MDD) earlier this year. MDD, commonly referred to simply as depression, affects around 350 million globally and is the leading cause of disability worldwide, according to the World Health Organization. (pharmaphorum.com 7.10.2016).)

(Anm: Lundbeck-produkt får nyt navn i USA. I USA er navnet på medicinalvirksomheden Lundbecks depressionsmiddel Brintellix blevet forvekslet med navnet på et blodfortyndende middel, og derfor får Brintellix nu nyt navn. (…) Nu har Lundbeck taget konsekvensen af navneforvekslingen og omdøbt depressionsmidlet Brintellix, så det i stedet vil være at finde med etiketten Trintellix, når […] (dagenspharma.dk 4.5.2016).)

(Anm: Antidepressiva (nytteverdi) (mintankesmie.no).)

(Anm: Ny forskning: Lykkepiller gør mere skade end gavn. Folk med depression får intet ud af at tage antidepressivet SSRI, bedre kendt som lykkepiller, viser nyt dansk studie. (jyllands-posten.dk 13.2.2017).)

(Anm: Forskere finner link mellom bruk av antidepressiva, medfødte misdannelser eller dødfødsler. (Researchers Find Link Between Antidepressant Use, Congenital Anomalies or Stillbirths) (…) "Mens denne ekstra risikoen kan virke liten er resultatene etter mitt syn så alvorlig som de kan være." (“While this extra risk may seem small, in my view, the outcomes are as serious as they can be.”) (dgnews.docguide.com 5.12.2016).)

(Anm: Eksponering av foster for antidepressiva kan endre Corpus Callosums mikrostruktur: Presentert ved PAS / ASPN. (…) Fordi "den neonate (nyfødtes) corpus callosum mikrostruktur er assosiert med utero (livmor) SSRI-eksponering og prenatal (før fødsel) mødredepresjon, er tidlige modningsprosesser i denne regionen følsomme for endret 5-hydroksytryptamin (5-HT) signalering under tiden i utero (livmor)," bemerket Campbell. "Disse resultatene - sammen med forstyrret hvit substans’ mikrostruktur i genu hos premature spedbarn - tyder dette på at utviklingen av [corpus callosum] kan være følsom for tidlige uheldige påvirkninger. (Fetal Exposure to Antidepressants May Alter Corpus Callosum Microstructure.) (dgnews.docguide.com 10.5.2017).)

(Anm: Unormal sæd med SSRI antidepressiva. Flere studier har funnet endrede sædparametere etter eksponering for SSRI-antidepressiva. Selv om SSRIs rolle er usikker, er det berettiget å ta hensyn til de observerte effektene på sædkvalitet og informere eksponerte pasienter. (Semen abnormalities with SSRI antidepressants. Several studies have found altered semen parameters after exposure to SSRI antidepressants. Although the role of SSRIs is uncertain, it is justified to take into account the observed effects on sperm quality and to inform exposed patients.) Prescrire Int 2015; 24 (156): 16-17.)

(Anm: Gravide kvinner som tar antidepressiva er mer sannsynlig å få barn med autisme, ifølge studie. Pregnant women who take antidepressants more likely to have a child with autism, study finds. Research data published in the BMJ reveal that antidepressant use during pregnancy increases the risk of autism in children, as reported The Independent Thursday. (firstwordpharma.com 20.7.2017).)

(Anm: - Nye data viser økt risiko for misdannelser når antidepressiva brukes under graviditet. (…) En studie publisert i British Medical Journal (BMJ) avslører at antidepressiva forskrevet til gravide kan øke sjansen for å få en baby med misdannelser.) (New Data Show Heightened Risk of Birth Defects When Antidepressants Are Used During Pregnancy.) (dgnews.docguide.com 19.1.2017).)

(Anm: - Utviklingen av et potensielt livstruende serotonergt syndrom eller nevroleptisk malignt syndrom (NMS)-lignende reaksjoner er rapportert for SNRI-er og SSRI-er alene, inkludert Celexa-behandling, men spesielt ved samtidig bruk av serotonerge legemidler (inklusive triptaner) og legemidler som svekker metabolisme av serotonin (inklusive MAO-hemmere), eller med antipsykotika eller andre dopaminantagonister (fda.gov 6.3.2009).)

(Anm: Antidepressant use during pregnancy and the risk of major congenital malformations in a cohort of depressed pregnant women: an updated analysis of the Quebec Pregnancy Cohort. (…) Conclusions Antidepressants with effects on serotonin reuptake during embryogenesis increased the risk of some organ-specific malformations in a cohort of pregnant women with depression. BMJ Open 2017;7:e013372.)

(Anm: Bruk av antipsykotika er assosiert med en 60 % økt risiko for dødelighet hos pasienter med Alzheimers sykdom. (…) Bruk av to eller flere antipsykotika samtidig ble knyttet til nesten doblet dødsrisiko (200 %) enn ved monoterapi.) (Antipsychotic Drug Use Increases Risk of Mortality Among Patients With Alzheimer’s Disease. JOENSUU, Finland -- December 12, 2016 -- Antipsychotic drug use is associated with a 60% increased risk of mortality among patients with Alzheimer's disease, according to a study published in the Journal of Alzheimer’s Disease. The risk was highest at the beginning of drug use and remained increased in long-term use. Use of 2 or more antipsychotic drugs concomitantly was associated with almost 2 times higher risk of mortality than monotherapy.) (dgnews.docguide.com 12.12.2016).)

(Anm: Antipsykotika dobler dødsrisiko allerede etter 180 dagers bruk. Greater Mortality Risk With Antipsychotics in Parkinson's (Større dødsrisiko med antipsykotika ved Parkinsons) (medicalnewstoday.com 21.6.2015).)

(Anm: (...) For ytterligere å illustrere problemet kan nevnes at antipsykotika forårsaker parkinsonisme (5), og en studie fant at mennesker med Parkinsons sykdom og psykose hadde fire ganger større sannsynlighet for å dø etter tre til seks måneders behandling enn de som ikke fikk antipsykotika. (6) De var også mer utsatt for kognitiv svikt, forverring av parkinsonsymptomer, hjerneslag, infeksjoner og fall. RE: Psykisk syke lever kortere. Tidsskr Nor Legeforen 10.11.2015.)

(Anm: Legemidler som kan gi delirium hos eldre. Delirium ses særlig hos eldre ved akutte sykdommer og skader eller som følge av toksisk eller farmakologisk påvirkning. Eldre personer har mange sykdommer og bruken av legemidler er høy. Mange legemidler, og særlig de med antikolinerg eller dopaminerg effekt, kan gi delirium. Kjennskap til legemidler og kombinasjoner av legemidler som kan gi delirium, er viktig for å kunne forebygge og behandle tilstanden. Tidsskr Nor Legeforen 2005; 125:2366-7 (8.9.2005).)

(Anm: Delirium in hospitalized patients: Risks and benefits of antipsychotics. ABSTRACT Consensus panel guidelines advocate for the judicious use of antipsychotic drugs to manage delirium in hospitalized patients when nonpharmacologic measures fail and the patient is in significant distress from symptoms, poses a safety risk to self or others, or is impeding essential aspects of his or her medical care. Here, we review the use of haloperidol, olanzapine, quetiapine, risperidone, and aripiprazole for this purpose. Cleveland Clinic Journal of Medicine. 2017 August;84(8):616-622.)

(Anm: Post injektionssyndrom. (…) De fleste af disse patienter udviklede symptomer på sedation (fra mild sedation til koma) og/eller delirium (herunder forvirring, desorientering, ophidselse/ uro, angst og anden kognitiv svækkelse). Andre symptomer inkluderede ekstrapyramidale symptomer, dysartri, ataksi, aggression, svimmelhed, svaghed, hypertension eller krampe.) (sundhedsstyrelsen.dk 29.6.2014).)

(Anm: Mødre til børn med misdannelser har øget dødelighed. (…) Bivirkninger har ført til to dødsfald. Den største del af bivirkningerne (42 procent) af de 429 blev indberettet for såkaldte psykostimulerende lægemidler - eksempelvis til behandling af ADHD - efterfulgt af 31 procent for antidepressiver og 24 procent for antipsykotiske lægemidler. (videnskab.dk 20.12.2016).)

(Anm: Antikolinerge effekter av vanlige legemidler knyttet til økt dødelighet hos mennesker over 65. De kombinerte antikolinerge effektene av mange vanlige legemidler øker risikoen for kognitiv svekkelse og død hos personer over 65 år, ifølge resultater fra en storskala studie på den langsiktige helseeffekten av legemidler.(Anticholinergic effects of common drugs are associated with increased mortality in over 65s. The combined anticholinergic effects of many common drugs increase the risk of cognitive impairment and death in people aged over 65, a large scale study of the long term effect of drugs on health has found.) BMJ 2011; 342:d4037 (28 June).)

(Anm: Men experience greater cognitive impairment and increased risk of death following hip surgery. In a study of hip fracture patients, men displayed greater levels of cognitive impairment within the first 22 days of fracture than women, and cognitive limitations increased the risk of dying within six months in both men and women. "While men make up only about 25 percent of all hip fractures, the number of men who fracture their hip is increasing and we know men are more likely to die than women after a hip fracture," said Dr. Ann Gruber-Baldini, lead author of the Journal of the American Geriatrics Society study. (medicalnewstoday.com 10.2.2017).)

(Anm: Det autonome nervesystemet. Det autonome nervesystemets hovedoppgave er å bidra til likevekt i kroppens basale funksjoner. Det vil blant annet si kroppstemperatur, blodtrykk, åndedrett og fordøyelse. (nhi.no 4.3.2015).)

(Anm: Ulike selektive serotonin reopptakshemmeres (SSRI-er) cytotoksisitet mot kreftceller. (Cytotoxicity of different selective serotonin reuptake inhibitors (SSRIs) against cancer cells.) (…) Vi har funnet at paroxetine (paroksetin; Seroxat; Paxil etc.) har cytotoksisk aktivitet mot tumorceller. J Exp Ther Oncol. 2006;6(1):23-9.)

(Anm: Could antidepressants stop prostate cancer from spreading? In almost all cases where prostate cancer spreads to other areas of the body, the disease spreads to the bone first. In a new study, researchers reveal the discovery of an enzyme that helps prostate cancer cells to invade bone. Furthermore, certain antidepressant medications may have the potential to block this enzyme. Study co-author Jason Wu, of Washington State University-Spokane, and colleagues recently reported their findings in the journal Cancer Cell. (medicalnewstoday.com 13.3.2017).)

(Anm: Classic cytotoxic drugs: a narrow path for regulatory approval. Several classic cytotoxic drugs have shown encouraging activity in the treatment of metastatic breast cancer.1–3 However, only a few have received an overwhelming welcome from regulatory authorities and succeeded in obtaining widespread regulatory approval for routine use. For example eribulin was approved for treatment of metastatic breast cancer in several countries including Japan, USA, and Europe, based on data that showed longer overall survival in patients treated with eribulin compared with patients treated with physician's choice of treatment. In contrast ixabcpilone with capecitabine gained approval from the US Food and Drug Agency based on data showing longer progression-free survival compared with capccitabine alone, but did not obtain rcgulatory authorisation in Europc because it is associated with a high incidence of nevropathy.5 Lancet Oncol. 2017 Feb 10. pii: S1470-2045(17)30089-X. [Epub ahead of print].)

(Anm: Ødelagt cellulær "klokke" linket til hjerneskade (Broken Cellular 'Clock' Linked to Brain Damage) (sciencedaily.com 25.11.2013).)

(Anm: Signaling Pathways Linked to Serotonin-Induced Superoxide Anion Production: A Physiological Role for Mitochondria in Pulmonary Arteries. Abstract. Serotonin (5-HT) is a potent vasoconstrictor agonist and contributes to several vascular diseases including systemic or pulmonary hypertension and atherosclerosis. Although superoxide anion ([Formula: see text]) is commonly associated to cellular damages due to [Formula: see text] overproduction, we previously demonstrated that, in physiological conditions, [Formula: see text] also participates to the 5-HT contraction in intrapulmonary arteries (IPA). Front Physiol. 2017 Feb 9;8:76. eCollection 2017.)

(Anm: Bruk av antidepressiva ble assosiert med et betydelig eldre utseende og forskere fant også ut at vekten spilte en viktig faktor. I de sett med tvillinger som var yngre enn 40 år ble tyngre tvillinger oppfattet som eldre. (…) I tillegg mistenker forskerne at den vedvarende avslapping av ansiktsmuskler som antidepressiva forårsaker kan forklare årsaken til at ansiktet faller sammen (henger). (mintankesmie.no).)

(Anm: Minislag (ministroke: transient ischemic attack (TIA)) linket til lavere forventet levetid. (- Minislag kan forårsake demens.) (- Enkelte psykofarmaka kan øke risiko for minislag / demens.) (mintankesmie.no).)

(Anm: Stumme infarkt rammer oftere folk med høy smertetoleranse. Stumme hjerteinfarkt gir ikke de klassiske brystsmertene som ved vanlige infarkt. - Denne pasientgruppen tar enten ikke kontakt med lege, eller de har ikke fått riktig diagnose, sier lege og forsker Andrea Milde Øhrn. (…) Det er vanlig å tenke sterke brystsmerter og akutt behandling når det er snakk om hjerteinfarkt. Det mange kanskje ikke vet, er at man kan ha hatt et hjerteinfarkt uten å vite det. Dette kalles et stumt infarkt, et hjerteinfarkt med få eller ingen symptomer. - Et stumt hjerteinfarkt er et hjerteinfarkt som ikke er erkjent. (nhi.no 3.2.2017).)

(Anm: Sannsynlig karotidyni forårsaket av fluoxetine (Prozac; SSRI-er). (Probable fluoxetine-induced carotidynia.)  Karotidyni er en fokal nakkesmerte (bestemt, avgrenset område), som involverer anatomiske områder til den berørte arteria carotis, og stråler ofte ut i den ipsilateral side (samme side) av ansiktet eller øret. På grunnlag av medisinsk historie og alder har karotidyni konvensjonelt vært klassifisert i klassisk (ikke-migrenøs), migrenøs, og vaskulære varianter. The Lancet 2009;374(9695):1061-1062 (26 September).)

(Anm: Nakkesmerter sætter forskerne skakmat. Kroniske nakkesmerter koster samfundet milliarder og er en af de hyppigste årsager til, at danskere melder sig syge fra job. Forskerne er i vildrede: Ingen behandling er effektiv. (videnskab.dk 22.12.2016).)

(Anm: Antidepressiva linket til hjerterisiko: tvillingstudie. (Antidepressants linked to heart risk: twins study) - Middelaldrende menn som bruker antidepressiva er mer sannsynlig å ha en innsnevring av blodårer, noe som øker risikoen for hjerteinfarkt og slag, enn de som ikke bruker legemidlene, ifølge en studie presentert på lørdag. (Reuters) - Middle-age men who use antidepressants are more likely to have a narrowing of blood vessels, increasing the risk of heart attacks and strokes, than those who do not use the medications, according to a study presented on Saturday.) (reuters.com 2.4.2011).)

(Anm: - Pfizers Zyvoxid (Zyvox) og antidepressiva kan være en dødelig kombinasjon. (- Det antas at når linezolid gis til pasienter, som behandles med serotonerge psykofarmaka, kan forhøyede nivåer av serotonin bygge seg opp i hjernen og forårsake toksisitet (giftighet). Dette er referert til som Serotonin syndrom - tegn og symptomer inkluderer mentale endringer (forvirring, hyperaktivitet, minneproblemer), muskelrykninger, overdreven svetting, skjelving eller risting, diaré, problemer med koordinasjon og / eller feber.) (fda.gov 21.10.2011).)

(Anm: Hva er det forskrivere og pasienter ikke vet om bivirkninger av antidepressiva? (What do prescribers and patients not know about the side effects of antidepressant drugs?) (medicalnewstoday.com 15.9.2016).)

(Anm: Forskere: Alvorlige bivirkninger, når antidepressiver droppes. Angst, depression og selvmordstanker er nogle af de bivirkninger, som tit forekommer, når man holder op med at tage antidepressiv medicin. Bivirkningerne kan i nogle tilfælde være langvarige og kroniske, viser et nyt studie. (videnskab.dk 16.3.2015).)

(Anm: Bruk av visse smertestillende midler (og antidepressiva (+ 31 %)) forbundet med økt risiko for drap (Use of certain painkillers linked with increased risk of homicide) Enkelte legemidler som påvirker sentralnervesystemet - som smertestillende og beroligende benzodiazepiner - er assosiert med økt risiko for å begå et drap, finner en ny studie publisert i tidsskriftet World Psychiatry. (medicalnewstoday.com 1.6.2015).)

(Anm: Psykiatriske patienter ender i private botilbud. Drab og vold har de seneste år fyldt debatten om de danske bosteder for patienter med psykiske problemer. (…) Psykiatriske patienter ender i private botilbud. (…) Mens Folketinget kæmper for en løsning på problemet med vold på offentlige bosteder, vælger flere kommuner at sende tunge patienter til private tilbud. (politiken.dk 18.3.2017.)

(Anm: Aggresjon knyttet til økt risiko for substansmisbruk. Aggression disorder linked to greater risk of substance abuse. (…) In the study, published in the Journal of Clinical Psychiatry, Emil Coccaro, MD, and colleagues analyzed data from more than 9,200 subjects in the National Comorbidity Survey, a national survey of mental health in the United States. They found that as the severity of aggressive behavior increased, so did levels of daily and weekly substance use. The findings suggest that a history of frequent, aggressive behavior is a risk factor for later substance abuse, and effective treatment of aggression could delay or even prevent substance abuse in young people. (medicalnewstoday.com 2.3.2017).)

(Anm: Halvparten av norske drap begått av rusede. (…) I 125 av drapene – eller 54 prosent – er det beskrevet i dommen at gjerningspersonen var påvirket av rusmidler under drapet. (nrk.no 13.12.2016).)

- En pasient på UNN døde av blodforgiftning som følge av et legemiddel mot psykiske lidelser, opplyser Statens helsetilsyn.

(Anm: En pasient på UNN døde av blodforgiftning som følge av et legemiddel mot psykiske lidelser, opplyser Statens helsetilsyn. (- Pasienten døde etter kort tid, og dødsårsaken var nøytropen sepsis (blodforgiftning), heter det i tilsynets rapport. (nrk.no 12.10.2016).)

(Anm: Systemic inflammatory response syndrome (SIRS) is an inflammatory state affecting the whole body, frequently a response of the immune system to infection. (en.wikipedia.org).)

(Anm: Sepsis. Definisjon: SIRS + påvist/mistenkt infeksjon (f. eks. positiv blodkultur). SIRS- kriteriene er: - Feber > 38 ºC eller hypotermi < 36 ºC - Puls > 90/minutt - Respirasjonsfrekvens > 20/minutt eller hypokapni med pCO2 < 4,3 kPa i blodgass - Leukocytose ≥ 12 × 109/l eller leukopeni < 4 × 109/l eller > 10 % umodne leukocytter. (helsebiblioteket.no - Metodebok for indremedisinere, 2012).)

(Anm: Rollen til mitokondriell dysfunksjon (mitokondriedysfunksjon) ved sepsis (blodforgiftning)-indusert multiorgansvikt. (The role of mitochondrial dysfunction in sepsis-induced multi-organ failure). (Virulence. 2013 Nov 1;5(1).)

- Diagnostisering av sepsis. Sepsis, også kjent som blodforgiftning, er kroppens hyperaktive respons på en infeksjon som kan føre til betennelse, vevskader, organsvikt etc.

(Anm: Diagnosing Sepsis. Sepsis, also known as blood poisoning, is the body’s hyperactive response to an infection that can lead to inflammation, tissue damage, organ failure etc. It is a very dangerous state in which the immune system stops fighting with the invading agents  and turns to itself. Around one-third of patients who are affected with sepsis die every year. (news-medical.net 7.9.2017).)

- Å anerkjenne sepsis som en global helseprioritet - En WHO- resolusjon.

(Anm: Å anerkjenne sepsis som en global helseprioritet - En WHO- resolusjon. Recognizing Sepsis as a Global Health Priority — A WHO Resolution. “Some very important clinical issues, some of them affecting life and death, stay largely in a backwater which is inhabited by academics and professionals and enthusiasts, dealt with very well at the clinical and scientific level but not visible to the public, political leaders, leaders of healthcare systems... The public and political space is the space in which [sepsis] needs to be in order for things to change.” NEJM (June 28, 2017).)

(Anm: Sepsis – den dödliga sjukdomen som glöms bort. Trots att infektionssjukdomen sepsis förekommer oftare än de vanligaste formerna av cancer och att upp emot hälften som drabbas av den allvarligaste formen dör, så har många knappt hört talas om sjukdomen. Sepsis som är den medicinska termen på blodförgiftning, drabbar omkring 40 000 svenskar varje år. (netdoktor.se 7.6.2017).)

- Hurtigtest finner tegn på sepsis i en enkelt dråpe blod.

(Anm: Hurtigtest finner tegn på sepsis i en enkelt dråpe blod. (- Sepsis, en potensielt livstruende komplikasjon av en infeksjon, har den høyeste byrde mht. død og medisinske utgifter på sykehus over hele verden.) (- Quick test finds signs of sepsis in a single drop of blood. (…) Sepsis, a potentially life-threatening complication of an infection, has the highest burden of death and medical expenses in hospitals worldwide. (medicalnewstoday.com 5.7.2017).)

(Anm: Nye sepsiskriterier kan føre til forsinket behandling. (…) Sepsis er en svært alvorlig tilstand med høy morbiditet og mortalitet (2). Den totale insidensen er ukjent, men man regner med at sepsis er en av de viktigste årsakene til alvorlig, akutt sykdom på verdensbasis (1). (…) Sepsis har inntil nylig vært definert som mistenkt infeksjon med samtidig tilstedeværelse av to eller flere SIRS-kriterier (1). Endringer i hjertefrekvens, kroppstemperatur, respirasjonsfrekvens og leukocytter er kroppens tegn på inflammasjon, og de indikerer ikke nødvendigvis en livstruende, dysregulert vertsrespons på infeksjon. Tidsskr Nor Legeforen 2017; :609-10 (20.4.2017).)

(Anm: LEGENE FORSTO IKKE AT HAN VAR DØDSSYK: Stian (19) døde etter 18 timer på sykehus uten legetilsyn. (…) Helsetilsynet konkluderer med at sykehusets behandling var uforsvarlig. (…) Fikk ikke beskjed. (…) Fastlegen sendte med dem papirer som foreldrene leverte på Akuttmottaket ved Ahus, der sto det; «Diagnose: Obs sepsis».  (tv2.no 29.4.2017).)

(Anm: Svikt i behandlingen av akutt syk ung mann i akuttmottaket – brudd på helselovgivningen. (…) Pasienten ble lagt på observasjonsposten (Akutt 24) ved akuttmottaket frem til neste morgen. I løpet av tiden på observasjonsposten ble han ikke tilsett av lege. På morgenen var han betydelig verre og han fikk tegn på fullt utviklet blodforgiftning. Behandling med antibiotika ble iverksatt, men han døde kort tid etter som følge av meningokokksepsis og hjerneødem. (helsetilsynet.no 2.5.2017).)

(Anm: Sepsis; grunnleggende kliniske observasjoner. Sepsis= En systemisk inflammatorisk respons (SIRS) pga. en infeksjon Tre alvorlighetsgrader: 1) Sepsis (to eller flere symptomer på SIRS som følge av infeksjon) 2) Alvorlig sepsis (sepsis med akutt organdysfunksjon, hypoperfusjon eller hypotensjon) 3) Septisk sjokk (hypotensjon til tross for adekvat væsketerapi, samt forekomst av perfusjonsforstyrrelser og organdysfunksjon) (hnt.no 5.11.2013).)

- Alle bryt lova i behandling av blodforgifting. Pasientar med alvorleg blodforgifting (sepsis) blir undersøkt av lege for seint.

(Anm: Alle bryt lova i behandling av blodforgifting. Pasientar med alvorleg blodforgifting blir undersøkt av lege for seint. Helsetilsynet fann brot ved 24 akuttmottak over heile landet. – Svært alvorleg. – Dette er svært alvorleg, for det dreier seg om ein alvorleg infeksjonssjukdom som i verste fall kan medføra død dersom behandlinga ikkje blir igangsett til riktig tid, seier avdelingsdirektør i Helsetilsynet, Ragnar Hermstad. OVER EIN TIME: Pasientar som kjem inn med teikn på alvorleg infeksjonssjukdom som blodforgifting skal ifølge nasjonale retningslinjer få anitibiotikabehandling innan maks ein time. Alle dei 24 akuttmottaka hadde svikt på dette området. (nrk.no 16.6.2017).)

(Anm: Lege sier improvisert «kur» for sepsis har hatt bemerkelsesverdige resultater. (…) Spesialist i intensivbehandling Paul Marik sier at enkel behandling med infusjon av vitamin C og steroider har bemerkelsesverdig effekt på pasienter med potensielt dødelig tilstand. (independent.co.uk 24.3.2017).)

(Anm: Bivirkninger underrapporteres i videnskabelige tidsskrifter. (...) Mellem 43 og 100 procent af de bivirkninger, der, ifølge det ikke-publicerede materiale, er fundet ved de testede lægemidler, er ikke lagt frem i de videnskabelige artikler, viser Yoon Loke og kollegernes gennemgang. (videnskab.dk 5.10.2016).)

(Anm: Dødsfall på grunn av nøytropen sepsis (blodforgiftning) etter behandling med legemiddelet klozapin – uforsvarlig oppfølging – mangelfull samhandling og informasjon. (…)  Manglende informasjon fra spesialisthelsetjenesten og mangelfull samhandling mellom kommunehelsetjenesten, fastlegen, pasienten og pårørende bidro til hendelsen. Helseforetaket skal gjennomgå hendelsen for å redusere risikoen ved lignende tilfeller. (helsetilsynet.no 12.10.2016).)

(Anm: Eksplosjon av antidepressiva til unge jenter. De ønsker psykologhjelp. I stedet blir de fôret med piller fra fastlegen. Unge jenter har aldri brukt mer antidepressiver. (vg.no 10.9.2016).)

(Anm: Flere barn og unge akuttinnlegges for psykisk sykdom. I fjor utgjorde andelen øyeblikkelig hjelp innleggelser 61 prosent av alle innleggelser. Det er en økning fra 47 prosent i 2012. (dagensmedisin.no 19.9.2016).)

(Anm: Eksplosjon av antidepressiva til unge jenter: Lykkepillegenerasjonen. «Lykkepillen» gjorde Sandra så dårlig at hun ble innlagt på psykiatrisk avdeling. På ti år har bruken av antidepressiver blant unge jenter økt med 83 prosent. Mange får pillene uten en gang å ha snakket med psykolog.  (vg.no 10.9.2016).)

(Anm: Helseminister Bent Høie reagerer på «lykkepille»-praksis: – Veldig urovekkende. ** Kraftig økning i antidepressiva til unge jenter. Helseminister Bent Høie reagerer på den sterke økningen i lykkepillebruk blant unge jenter. Han mener manglende ressurser og fastlegers holdninger er årsaker. Lørdag dokumenterte VG Helg og VG+ konsekvensene av den økende lykkepille-bruken blant unge jenter. (vg.no 10.9.2016).)

(Anm: LO advarer mot trygdebombe. En stadig større del av nordmenn i arbeidsfør alder er uten jobb. LO mener dette er en potensiell trygdebombe. (…) Det trengs 180.000 nye jobber for å få yrkesdeltakelsen opp på samme nivå som i 2008, viser en rapport fra samfunnsøkonomene i LO. I 2008 var 70 prosent av befolkningen mellom 15 og 74 år i jobb. Nå er yrkesdeltakelsen nede i 67,3 prosent., og det er nedgang i alle fylker. (hegnar.no 6.10.2016).)

(Anm: Rekordmange søger akut psykisk hjælp. (- Mens kun 12.099 danskere i 1995 besøgte de psykiatriske akutmodtagelser og skadestuer, er det steget til hele 33.333 i 2015, viser opgørelse fra Sundhedsdatastyrelsen og Danske Regioner, der for kort tid siden blev sendt til Folketinget. (politiken.dk 9.7.2016).)

(Anm: Har vi blitt psykisk sykere? (- Vi vet også at stadig flere får uførepensjon på grunn av psykiske lidelser og at sykefraværet på grunn av psykiske plager og lidelser har økt. Vi tror alle disse forholdene bidrar til vår oppfatning om at stadig flere får en psykisk lidelse eller plage.) (Folkehelseinstituttet fhi.no 10.10.2013).)

(Anm: Høyt fravær på grunn av ME. Minst 270 elever var borte fra skolen i fjor fordi de hadde ME. (aftenposten.no 6.2.2017).)

(Anm: Psykisk ohälsa fortsätter att öka. Antalet svenskar som sjukskrivs på grund av psykisk ohälsa ökar kontinuerligt sedan 2010. Den vanligaste diagnosen är stressrelaterad psykisk ohälsa som till mångt och mycket är arbetsrelaterad. Då evidensbaserad behandling saknas står förebyggande arbete i fokus. (netdoktor.se 14.9.2016).)

(Anm: Psykiatriske skadestuer kan ikke klare presset. Psykiske lidelser hører til nogle af de største sygdomsbyrder, som hvert år koster samfundet et svimlende milliardbeløb i tabt arbejdsfortjeneste og sociale ydelser. (politiken.dk 11.7.2016).)

(Anm: - 9 ting som skjer i hjernen og kroppen på MDMA (Ecstasy). (- 9 Things That Happen in the Brain and Body on MDMA.) (- Derfor, når substansen avsluttes, sitter mennesker igjen med mindre serotonin enn vanlig, noe som kan føre til følelser av depresjon, irritabilitet og tretthet.) (- Siden MDMA frigir så mye serotonin, ødelegger kroppen deretter mer serotonin enn vanlig, ifølge AsapSCIENCE.) (thescienceexplorer.com 24.6.2016).)

(Anm: Lundbecks depressionshåb har det svært i Europa. Problemer med at få sat en pris på depressionsmidlet, Brintellix, i de store lande i Europa, illustrerer, hvorfor Lundbeck i fremtiden vil satse mindre og mindre på sit gamle traditionelle marked og langt mere på USA og andre områder i verden. (medwatch.dk 10.2.2016).)

(Anm: Legemiddelkonsulenter (sales representatives) (mintankesmie.no).)

(Anm: Legemiddelkonsulenter forteller leger lite om sideeffekter, ifølge studie. (Drug Reps Tell Docs Little of Side Effects: Survey) (Journal of General Internal Medicine 2013 (April).)

(Anm: Interessekonflikter vanlig blant forfattere av amerikanske retningslinjer for kreft, ifølge studie. (Conflicts of interest common among US cancer guideline authors, study finds.) BMJ 2016;354:i4660 (Published 25 August 2016).)

(Anm: Selgere i kirurgenes rekker: Relasjoner mellom kirurger og medisinske utstyrsrepresentanter (Salespeople in the Surgical Suite: Relationships between Surgeons and Medical Device Representatives. PLoS ONE 11(8): e0158510).

(Anm: - Nesten ni av 10 leger og forskere som bidro til å utvikle et førende sett med retningslinjer for kreftomsorgen i USA rapporterte finansielle bånd til legemiddelindustrien og medisinske utstyrsfirmaer). (medicalnewstoday.com 30.8.2016).)

(Anm: Ingen gratis lunsj for leger: Sponsede måltider knyttet til flere resepter (No free lunch for docs: Sponsored meals linked to more prescriptions) (mmm-online.com 20.6.2016).)

(Anm: Amerikansk statsadvokat undersøger forhold omkring Lundbeck-middel. En amerikansk statsadvokat har indledt en undersøgelse om blandt andet salg og marketing af Lundbecks Xenazine til behandling af Huntingtons sygdom. (medwatch.dk 10.2.2016).)

(Anm: Antidepressants v cognitive behavioural therapies. Patients in trials of antidepressants are not typical of those in everyday practice. BMJ 2016;352:i577 (Published 10 February 2016).)

(Anm: Kåre Schultz: ”Det er spørgsmålet, om man tør”. Det er slut med nye samarbejdsaftaler for Lundbeck, der fremover vil selv og i fremtiden kun vil vokse organisk. Sådan lyder den nye strategi fra topchef Kåre Schultz, der trækker på sine erfaringer fra Novo Nordisk. (medwatch.dk 10.2.2016).)

(Anm: Tommelfingeren op til Lundbeck-middel i USA. En ekspertgruppe indstillede sent i aftes, at FDA skal sige ja til, at Lundbecks nye depressionsmiddel kan forbedre kognitive evner. (medwatch.dk 4.2.2016).)

(Anm: Conflicts Common Among FDA Hearing Speakers. 'Industry has hijacked the microphone' (medpagetoday.com 1.2.2016).)

(Anm: Characteristics and Conflicts of Public Speakers at Meetings of the Oncologic Drugs Advisory Committee to the US Food and Drug Administration. JAMA Intern Med. 2016 (Published online February 01, 2016).)

(Anm: Lundbeck: Vrangvillige myndigheder giver os problemer i Europa. Det er svært at få medicin­tilskud til nye innovative produkter i Europa, lyder meldingen fra Lundbecks nye topchef. (dagenspharma.dk 20.8.2015).)

(Anm: Uriktig fremstilling av skader i studier på antidepressiva. Nye bevis fra kliniske studierapporter avdekker feilklassifisering, feiltolkning, og underrapportering av alvorlige skader. BMJ 2016;352:i217 (Published 28 January 2016).)

(Anm: Offentligt betalte forskere pynter på resultater af forsøg på mennesker. (videnskab.dk 14.3.2016).)

(Anm: Helsevesenet bruker ikke ny forskning. Norske pasienter får medisiner og behandling de ikke har bruk for fordi nye forskningsresultater ikke tas i bruk. Større problem enn unyttig forskning, mener eksperter. (forskning.no 2.1.2016).)

(Anm: Forvaltningsmakt og kunnskapspolitikk. Sammendrag. Helse- og omsorgsdepartementet benekter at de ønsker å styre forskninga i underliggende etater, og ser ingen problemer med at forskninga ligger under forvaltninga. Rus & Samfunn 05 / 2016 (Volum 9) Side: 33-35.)

(Anm: Frie forskere eller maktens lakeier? Abstrakt. Det går et skisma gjennom den samfunnsvitenskapelige rusforskningen. Ved første øyekast er det vanskelig å forstå hvorfor. Rus & Samfunn 05 / 2016 (Volum 9) Side: 36-40.)

(Anm: Lederartikler (Editorials) Tid for kunnskapsbasert forskningspolitikk Og offentlig finansierte forskere må være åpne om den sannsynlige betydningen av forskningen. (Time for evidence based research policy. And publicly funded researchers need to be candid about the likely impact of research). BMJ 2016;353:i3146 (Published 13 June 2016).)

(Anm: Kronikk: Kari Sollien, leder i allmennlegeforeningen. Hvorfor bruker ikke kommunene legenes kunnskap? Kunnskap skal redde velferdsstaten. I kommunene har ledelsen en lang vei å gå for å involvere helsepersonell i arbeidet med å utvikle helsetjenesten. (dagensmedisin.no 15.8.2016).)

(Anm: Leger ivaretar din mentale helse, men hvem ivaretas deres? (Doctors look after our mental health but who looks after theirs?) (theconversation.com 26.4.2016).)

(Anm: Dorothea Dix: Redefining mental illness. During the 19th century, mental health disorders were not recognized as treatable conditions. They were perceived as a sign of madness, warranting imprisonment in merciless conditions. One woman set out to change such perceptions: Dorothea Lynde Dix. (…) Dix - a teacher and nurse during the American Civil War - tirelessly campaigned for the fair treatment of patients with mental health disorders, after being appalled by the conditions in which they were confined. (medicalnewstoday.com 5.5.2017).)

(Anm: Tor K. Larsen, professor i psykiatri, Stavanger universitetssykehus: - Den valgfriheten som helseministeren nå ønsker å påtvinge helsevesenet vil føre til at mange svært alvorlig syke mennesker i praksis fratas retten til best mulig behandling. Innføring av medikamentfrie poster i psykiatrien er et gigantisk feilgrep. (dagensmedisin.no 29.7.2016).)

(Anm: Tre av 60.000 studenter ble tvunget til å slutte. Medstudenter og lærere varsler for sjelden om personer som ikke egner seg til yrket de utdanner seg til, mener fagfolk. Studenter som skal jobbe med mennesker og sårbare grupper, bør ikke ha rusproblemer, psykiske problemer, dårlige kommunikasjonsevner eller holdninger som ikke er forenlig med yrket. (aftenposten.no 18.8.2016).)

(Anm: - Hvorfor legers mentale helse bør være en bekymring for oss alle. (- Noen av de mer alarmerende resultater av å ha stressede og deprimerte leger er patologisk kynisme, en uvilje mot å ta vare på kronisk syke og redusert empati.)  (newstatesman.com 16.4.2016).)

(Anm: 27% of Medical Students Are Depressed. In the new research published in the Journal of the American Medical Association, researchers analyzed nearly 200 studies of 129,000 medical students in 47 countries. They found that 27% of medical students had depression or symptoms of it, and 11% reported suicidal thoughts during medical school. (time.com 10.12.2016).)

(Anm: LEDER. Ville du like å gå til en lege som er psykopat? Tidsskr Nor Legeforen 2008; 128:1805 (28.8. 2008).)

(Anm: Psychopathy of 1,800 prisoners leads to novel diagnostic tool for criminals and non-criminals alike (medicalnewstoday.com 12.8.2016).)

(Anm: Introduction and validation of Psychopathic Personality Traits Scale (PPTS) in a large prison sample. Conclusion. This brief measure of psychopathic traits uncontaminated with behavioral items can be used in the same way among participants with and without criminal history. Journal of Criminal Justice 2016;46: 9–17 (September 2016).)

(Anm: Efter fyringer og nedskrivninger: Nu skal Lundbeck levere. Markedet ser et stort lys i Lundbecks adm. direktør, Kåre Schultz. Spørgsmålet er, hvor hurtigt han og resten af selskabet kan levere varen. For tid er ikke det, man har mest af. (medwatch.dk 1.2.2016).)

(Anm: FDA panel backs game-changing cognitive claim for Lundbeck antidepressant Brintellix (…) If the FDA follows that advice, the drug would "be the only product on the market with a leaflet on cognitive effects," brokerage firm Alm. Brand wrote in a note to clients, as quoted by Reuters. The FDA is focusing on the drug's ability to improve thinking, attention and decision-making, "which means doctors also will," the firm said in its note, a potential boon for Lundbeck as it looks to reap more from the med. (fiercepharma.com 4.2.2016).)

(Anm: Analytiker: Anbefaling løfter Lundbecks værdi. Nattens anbefaling fra et amerikansk ekspertpanel af en udvidet indlægsseddel for depressionsmidlet Brintellix kan ifølge analytiker få markedet til at fokusere mere på de langsigtede muligheder hos Lundbeck. (medwatch.dk 4.2.2016).)

(Anm: Lundbeck brager til vejrs efter FDA-afstemning. Den opadvendte tommelfinger til, at Lundbecks depressionsmiddel har effekt på de kognitive evner hos patienterne, giver selskabets aktie vind i sejlene. (…) Afstemningen i FDA's ekspertpanel er blot en anbefaling til lægemiddelstyrelsen om at indføre ændringen. En positiv anbefaling er dog typisk så godt som en endelig godkendelse hos myndighederne. FDA ventes at træffe en endelig afgørelse om Brintellix den 28. marts, oplyser Lundbeck. (medwatch.dk 4.2.2016).)

(Anm: Antidepressiva (SSRI) (mintankesmie.no).)

(Anm: RE: Studier som stikkes under stol Minileder Tidsskr Nor Legeforen 2015; 135:617 (25.5.2015).)

(Anm: RE: Psykisk syke lever kortere. Tidsskr Nor Legeforen Tidsskr Nor Legeforen 2015; 135:246 – 8 (8.09.2015).)

(Anm: RE: Psykisk syke lever kortere. Tidsskr Nor Legeforen 2015; 135:1534 – 5 (22.9.2015).)

(Anm: RE: Psykisk syke lever kortere. Tidsskr Nor Legeforen Tidsskr Nor Legeforen 2015; 135:1923-4 (17.11.2015).)

- FDA avdekker at amerikansk firma som driver legemiddelforskning forfalsket dokumenter

FDA finds U.S. drug research firm faked documents (FDA avdekker at amerikansk firma som driver legemiddelforskning forfalsket dokumenter)
reuters.com 26.7.2011
(Reuters) - Drug companies that had medicines tested by contractor Cetero Research might have to reevaluate results, U.S. regulators warned after the firm was found faking documents and manipulating samples.

The Food and Drug Administration said on Tuesday two 2010 inspections, an internal company investigation and a third-party audit uncovered "significant instances of misconduct and violations" at a Cetero facility in Houston.

The Cary, North Carolina-based firm does early-phase clinical research and bioanalytics for a number of drugmakers. The pharmaceutical companies can then use those studies as supporting evidence in drug approval applications to the FDA.

"The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame," the FDA said, warning drugmakers they might have to repeat or confirm any studies Cetero did in support of their applications between April 2005 and June 2010.

It remains unclear which drugmakers have used Cetero's services to apply for regulatory approvals and the FDA is asking companies to identify such instances. The regulators said the measure is precautionary and the safety and efficacy of drugs already on the market are unlikely to be affected.

The FDA inspected Cetero in May and December last year and found falsified records about studies.

Specifically, in at least 1,900 instances between April 2005 and June 2009, laboratory technicians identified as conducting certain studies were not actually present at Cetero facilities at that time, the FDA said in its May report.

The FDA also said at the time that Cetero might have "fixed" studies to get the desired result, or did not include failed results in their report.

"Cetero's May 2010 and December 2010 responses are inadequate because the scope of their internal investigation was far too narrow to identify and adequately address the root cause of these systemic failures," the regulators said.

Cetero was not immediately available for comment. (...)

(Anm: Forskning og ressurser (mintankesmie.no).)

(Anm: Drug maker must restart obesity drug study after releasing early data. A major US study of a newly approved antiobesity drug that was designed to measure adverse cardiovascular effects has been stopped by its steering committee after the manufacturer revealed first quarter data in a patent application. BMJ 2015;350:h2844  (Published 22 May 2015).)

- Karsten Juhl Jørgensen, seniorforsker og dr.med. på det Det Nordiske Cochrane Center på Rigshospitalet, mener, at kliniske forsøg bør foregå uden for virksomhedernes eget regi.

Pharmadanmark: Stop med kritik – kom med forslag
pharmadanmark.dk 16.10.2015
Karsten Juhl Jørgensen, seniorforsker og dr.med. på det Det Nordiske Cochrane Center på Rigshospitalet, mener, at kliniske forsøg bør foregå uden for virksomhedernes eget regi. Antje Marquardsen, formand for Pharmadanmark efterspørger realistiske og finansieret alternative forslag.

edicinalindustrien manipulerer forskningsresultater til at se bedre ud og dermed gøre deres dyre medicin til nødvendige behandlingsmetoder, lyder kritikken fra Cochrane Center på Rigshospitalet i Orienteringen på P1 i mandags.
Karsten Juhl Jørgensen, seniorforsker og dr.med. på det Det Nordiske Cochrane Center på Rigshospitalet, siger, at der heller ikke er nok kontrol med medicinalmedicinen.

Han mener, at det helt grundlæggende er en fejl, at man lader medicinalindustrien sikkerhedsteste egne produkter.

»Gennemgangen af de studier, som medicinalindustrien producerer er slet ikke grundig nok. Vi ser igen og igen, at når uafhængige forskere får adgang til råmateriale fra kliniske forsøg, så ser virkeligheden meget anderledes ud, end hvordan det ser ud i medicinalindustriens videnskabelige litteratur,« siger Karsten Juhl Jørgensen.

Derfor opfordrer han til, at kliniske forsøg bør foregå uden for virksomhedernes eget regi. Men strukturen er der bare ikke til det i dag.
»Det vil kræve en omlægning af den måde, som man godkender lægemidler på. Jeg tror dog ikke, at vi får et sandfærdigt billede af, hvad de dyre lægemidler kan, ikke kan og hvilke skadevirkninger, der er, før vi får bedømmelser fra en uafhængig instans,« understreger han.

Formand for Pharmadanmark Antje Marquardsen synes, at det er ærgerligt, at hans udtalelser står uimodsagt i programmet. (…)

- Dødsfall i forsøk skal alltid rapporteres

Deaths in trials should always be reported (Dødsfall i forsøk skal alltid rapporteres)
BMJ 2013;347:f4219 (Published 4 July 2013)
In Novo Nordisk’s internal reports of trials of the diabetes drug repaglinide, Jeppe Schroll finds deaths that were not reported in published trials, potentially underplaying harms in subsequent analyses

Researchers generally do not publish what they planned to report in their protocols,1 and important differences can also exist between internal trial reports and published papers.2 It has been suspected that even deaths are sometimes omitted,3 but there is little direct evidence of this. (...)

In trial 048, one death was reported in the internal report, this time in the comparator arm, but not in the published paper.7 In trial 049, the internal report did not describe any deaths, but the published paper reported three deaths in the repaglinide arm and one in the sulfonylurea arm.8 The published paper for trial 049 also reported 19 cardiovascular events (5%) in the repaglinide arm compared with only four (2%) in the sulfonylurea comparator—but nonetheless, the conclusion was that repaglinide was well tolerated and safe.8 One of the never published trials (trial 046) had similar outcomes, with 25 cardiovascular events (14%) in the repaglinide arm compared with four (5%) in the sulfonylurea arm. However, the difference between groups was downplayed: the internal report concluded that the “frequency of adverse event[s] was similar.” This conclusion was reached even after tolbutamide—an earlier, similar sulfonylurea drug—had been shown to increase the number of cardiovascular deaths.9 (...)

(Anm: Kreftpasienter har for stor tro på nye og uprøvde medisiner. Noen av de sykeste kreftpasientene har urealistiske forventninger til at de skal få hjelp gjennom å prøve ut nye medisiner. De forstår heller ikke risikoen ved å delta i et forskningsprosjekt, ifølge en svensk studie. (…) De mest alvorlig syke forstår ikke at de neppe selv får ny tte av medisinene. De undervurderer dessuten risikoen ved å delta i forskningsprosjektet. (vg.no 25.8.2015).)

(Anm: Alnylam shares crater after trial deaths force investigators to scrap PhIII RNAi drug. Late Wednesday Alnylam shocked its investors with news that it has decided to scrap revusiran, its second most advanced RNAi therapy in the pipeline, due to a spike in the number of deaths among patients taking the drug in a late-stage trial. All dosing has been stopped and won’t be resumed. (endpts.com 5.10.2016).)

(Anm: EMA granskar cancerläkemedlet Zydelig. (…) Granskningen har påbörjats på grund av att en ökad frekvens av allvarliga biverkningar inklusive dödsfall (främst på grund av infektioner) har påvisats i tre kliniska studier där läkemedlet undersöks i kombination med andra cancerläkemedel. (lakemedelsverket.se 11.3.2016).)

(Anm: Spark Therapeutics shares slide after a setback on its hemophilia gene therapy study . Shares of Spark Therapeutics $ONCE, the most advanced gene therapy company in a growing field, were badly dented this morning after the Pfizer $PFE partner noted that one of 7 patients treated with their hemophilia B treatment experienced an immune response to the viral delivery vehicle they use. (endpts.com 3.11.2016).)

(Anm: Investigators sound a safety alarm after 2 patients die of heart condition following checkpoint combo. Checkpoint inhibitors like Keytruda and Opdivo quickly achieved legendary status as breakthrough cancer therapies with broad, blockbuster roles to play on the market. But in a new study published in the New England Journal of Medicine, investigators have spotlighted rare cases in which checkpoint patients have died or been afflicted by heart trouble. And there’s evidence that a T-cell driven reaction threatens a very small group of patients taking the drugs. Two melanoma patients died from myocarditis after taking a combination of Yervoy and Opdivo, according to the report. And 0.27% — a tiny sliver of the total — developed the condition, a potentially fatal, T-cell–driven drug reaction. (endpts.com 3.11.2016).)

(Anm: Cancerläkemedel granskas av EMA. På grund av en ökad frekvens av allvarliga biverkningar, inklusive dödsfall, granskar nu EMA cancerläkemedlet Zydelig. (lakemedelsvarlden.se 14.3.2016).)

(Anm: Bekymringer om alvorlige bivirkninger hos Gileads leukæmimiddel. Det Europæiske Lægemiddelagentur, EMA, sætter nu Gileads leukæmimiddel Zydelig under luppen efter et stigende antal skadelige tilfælde i tre kliniske studier. (medwatch.dk 14.3.2016).)

(Anm: Bayer halts midstage riociguat study after serious safety concerns. Bayer has terminated its Phase II study of riociguat in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) with “immediate effect.” The DMC did not identify any specific cause or common feature among the patients who died except that many appeared to have more serious and advanced underlying lung disease than the study population as a whole, according to a statement from Bayer. (fiercepharma.com 12.5.2016).)

- Patient i livsfare efter forsøg med muskelsvindsmiddel.

Patient i livsfare efter forsøg med muskelsvindsmiddel
dagenspharma.dk 28.1.2016
Et amerikansk biotekselskab har sat et klinisk studie på hold, efter en patient er kommet i livsfare. Patienten var blevet givet den højeste dosis af en lægemiddelkandidat til behandling af Duchennes muskeldystrofi.

En patient er kommet i livsfare efter et klinisk forsøg med lægemiddelkandidaten HT-100 til behandling af muskelsvindsygdommen Duchennes muskeldystrofi (DMD). Det skriver FierceBiotech.

Selskabet bag forsøget, Akashi Therapeutics, oplyser i en pressemeddelelse, at patienten, der er blevet givet den højeste dosis (60 mikrogram per kilo) oplever "alvorlige og livstruende sundhedsproblemer."
Akashi har nu suspenderet forsøget med HT-100, og arbejder tæt sammen med de amerikanske sundhedsmyndigheder, FDA, for at analysere situationen. Man ved endnu ikke, om patientens helbredsproblemer er relateret til HT-100 eller andre faktorer.

Biotekselskabet forventer at genoptage studiet, når undersøgelsen af patientens ulykkelige omstændighed er færdig, og at man er sikre på, at eventuelle tiltag, der viser sig at være nødvendige, er på plads for at løse årsagerne. (...)

(Anm: Risks of non-oncology phase I research. Time to abandon three-phase trials? Emmanuel and colleagues conclude that “concerns about the high risks of serious harm in non-oncology phase I trials do not seem to be borne out.”1 But, although the risk may be small, the consequences can be tragic. BMJ 2016;352:i764 (Published 17 February 2016).)

- Allvarligt skadade i läkemedelstest (- Hjernedød etter fransk forsøk med legemiddel.) (- Seks kritisk skadet etter medisinforsøk i Frankrike.)

Allvarligt skadade i läkemedelstest
dagensmedicin.se 15.1.2016
Fem personer vårdas på sjukhus och en har förklarats hjärndöd efter ett misslyckat läkemedelstest i Frankrike.

Enligt hälsominister Marisol Touraine hade de sex personerna "deltagit i försök med ett läkemedel som tas oralt" i närheten av Rennes i nordvästra Frankrike. Vid en presskonferens sade Touraine att det portugisiska företaget Bial Lab är tillverkare av medicinen.

Ministern dementerar uppgifter om att det skulle röra sig om ett cannabisbaserat läkemedel.

Den person som förklarats hjärndöd kom till sjukhuset i Rennes i måndags, övriga fem sökte vård senare i veckan. Sammanlagt har 90 personer fått medicinen i olika doser.

Chefen för neurologiska avdelningen på sjukhuset i Rennes, Pierre-Giles Edan, säger att tre av dem som vårdas på sjukhuset har fått skador som kan bli bestående.

Testerna har avbrutits och en brottsutredning har inletts.

En person som är hjärndöd är enligt den svenska lagens definition död. (…)

(Anm: Seks kritisk skadet etter medisinforsøk i Frankrike. Frankrikes helseminister Marisol Touraine sier hun er fast bestemt på å komme til bunns i denne tragiske saken. - Veldig alvorlig ulykke, sier den franske helseministeren. (aftenposten.no 15.1.2016).)

(Anm:  Ofre i legemiddelstudie får "livsvarig sykdomsutvikling" (netdoctor.co.uk 31.7.2006).)

(Anm: French drug trial protocol fails to answer key questions. (…) The report revealed the chemical structure of the drug BIA 10-2474, developed by the Portuguese company Bial, and the trial procedure—single administrations of the drug at increasingly higher doses, followed by multiple administrations given on successive days. BMJ 2016;352:i466 (Published 25 January 2016).)

(Anm: Krav på stärkt skydd för försökspersoner. Rättigheterna för frivilliga som deltar i kliniska prövningar måste stärkas inom EU. Det kräver Frankrike efter den franska kliniska prövning då en person dog. I januari drabbades sex deltagare i en klinisk prövning i franska Rennes av neurologiska symtom. En av dem dog efter prövningen av ett läkemedel som ökar mängderna av cannabinoider i hjärnan. Med anledning av detta har den franska hälsoministern Marisol Touraine skickat ett brev till EU:s alla medlemsländer och till EU-kommissionen. I brevet kräver hon gemensamma åtgärder inom EU för att förhindra att något liknande händer igen. (dagensapotek.se 20.5.2016).)

(Anm: FDA frikender lægemiddelklasse efter fatalt fransk forsøg. De amerikanske godkendelsesmyndigheder FDA mener ikke, at de såkaldte FAAH-inhibitorer udgør en sikkerhedsrisiko, selvom et lægemiddel i denne klasse var årsagen til et fatalt fransk lægemiddelforsøg i januar. Der er ingen grund til at mistænke en hel klasse af lægemidler, fordi et enkelt forsøg fransk lægemiddelforsøg i januar fik fatale konsekvenser for en gruppe af forsøgspatienter. Det konkluderer de amerikanske godkendelsesmyndigheder FDA, som har færdiggjort en undersøgelse af fase 1-forsøget BIA 10-2474. En person døde og yderligere fem forsøgspersoner blev hospitalsindlagt, da forsøget […] (dagenspharma.dk 17.8.2016).)

- Fransk legemiddelkontroll gjorde ingen feil som tillot dødelig forsøk, ifølge vurdering.

French drug agency was not wrong to allow deadly trial, review says. (Fransk legemiddelkontroll gjorde ingen feil som tillot dødelig forsøk, ifølge vurdering.)
BMJ 2016;353:i2774 (Published 23 May 2016)
Den franske nasjonale legemiddelkontrollen gjorde ingen feil ved å godkjenne et legemiddelforsøk hvor en frivillig døde og fire fikk alvorlige nevrologiske bivirkninger, konkluderer den endelige rapporten fra en offisiell gjennomgang publisert 23. mai.1 Men Agence Nationale de Sécurité du Médicament (ANSM) skulle ha bedt om mer informasjon om opptrapping av doser som er beskrevet i protokollen heter det i rapporten, og den kritiserer feil gjort av firmaet som gjennomførte  studien. (The French national drug agency was not wrong to authorise a drug trial that left one volunteer dead and four with severe neurological side effects, concludes the final report of an official review published on 23 May.1 However, the Agence Nationale de Sécurité du Médicament (ANSM) should have asked for more details about the escalation of doses described in the protocol, the report said, and it criticised errors made by the company that conducted the trial.)

Mediekommentatorer og advokaten som representerer familien til den frivillige, Guillaume Molinet, som døde 17. januar etter å ha deltatt i den første fase I kliniske studien på mennesker med den eksperimentelle substansen BIA-10-2474, hadde hevdet at legemiddelkontrollen ikke skulle ha gitt klarsignal til å teste substansen på mennesker, fordi nevrologiske skadevirkninger hadde blitt rapportert ved dyreforsøk. Men den endelige rapporten fra Inspection Générale des Affaires Sociales (IGAS), bestilt av det franske helsedepartementet, er ikke enig. De gjentok imidlertid tre store feil som er identifisert i sin tidligere rapport publisert i februar. Disse feilene var måten forsøket ble drevet på av Biotrial, det firmaet som hadde kontrakt på forsøket med Bial, det portugisiske legemiddelfirmaet som utviklet substansen.2 (Media commentators and the barrister representing the family of the volunteer, Guillaume Molinet, who died on 17 January after participating in the first in humans phase I clinical trial of the experimental compound BIA-10-2474, had argued that the agency should not have given the go-ahead to test the drug in humans, because neurological adverse effects had been reported during animal testing. But the final report of the Inspection Générale des Affaires Sociales (IGAS), commissioned by the French health ministry, did not agree. It did, however, reiterate three major errors identified in its earlier report published in February. These errors were in the way that the trial was run by Biotrial, the clinical trial company contracted by Bial, the Portuguese drug company that developed the compound.2)

De frivillige deltok i en delstudie i forsøket, hvor dosen ble økt til 50 mg over 10 dager—mer enn dobbelt så mye som det som ble gitt til deltakerne i tidligere stadier av forsøket. (The volunteers were participating in the multiple ascending dose substudy of the trial, in which the dose had been increased to 50 mg for 10 days—more than twice as much as any dose given to participants in earlier stages of the trial.)

(Anm: EMA vil gennemgå praksis for kliniske forsøg. Oven på det fatale kliniske forsøg, der i januar kostede en fransk mand livet, vil den europæiske lægemiddelmyndighed nu gå praksis for kliniske forsøg efter i sømmene. (…) Det fatale franske forsøg, der i januar sendte seks personer på hospitalet og endte med at koste en mand livet, får nu konsekvenser. Den europæiske lægemiddelmyndighed, EMA, vil nemlig gennemgå de nuværende regler for kliniske forsøg for at se, om de kan strammes op. Det skriver FierceBiotech. (medwatch.dk 26.5.2016).)

(Anm: Derfor er fransk forsøg ikke registeret på ClinicalTrials.gov. Den portugisiske farmaceutiske virksomhed Bials registrering af det fatale forsøg med et lægemiddel er ikke offentligt tilgængelig. Forvirringen omkring, hvilket stof den portugisiske farmaceutiske virksomhed Bial brugte, var stor i dagene efter, at et forsøg på hospitalet i Rennes i Frankrig i sidste uge gik galt, og en person døde, mens fire af de fem øvrige forsøgspersoner fortsat er indlagt på Universitetshospitalet i Rennes. Forsøget var nemlig ikke at finde i clinicaltrials.gov. […] (dagenspharma.dk 22.1.2016).)

(Anm: Drug scandals in France: have the lessons been learnt? Despite some changes in recent years, much more can be done to prevent future scandals in France, say medical and legal experts.  Lancet 2016;388(10044):550–552 (6 August 2016).)

(Anm: Fejl ved fatalt fransk klinisk forsøg. Den franske sundhedsminister præsenterer i dag en rapport omkring det kliniske forsøg, der gik grueligt galt i Rennes i januar, og ventes at komme med en række nye regler for fremtidige forsøg. (…) Det skriver Reuters. (medwatch.dk 23.5.2016).)

(Anm: Hjernedød etter fransk forsøk med legemiddel. En person er hjernedød, og tre har fått alvorlige hjerneskader, etter at de sa ja til å være med på å prøve ut et nytt smertestillende legemiddel i Frankrike. (…) Ifølge de første meldingene var det snakk om et cannabis-basert legemiddel, men dette avviser det franske helsedepartementet. (tv2nyhetene.no 15.1.2016).)

(Anm: Du kan altid risikere at dø i et klinisk forsøg. Forsøgspersoner deltager altid med livet som indsats, når de er med i et klinisk forsøg, men det gør du også, når du går om bord i et fly. Risikoen vil altid være der, siger to danske forskere. Ifølge Birgitte Søgaard, som er leder af området for fase 1-forsøg hos medicinalvirksomheden Lundbeck, bliver reglerne på området for kliniske forsøg hele tiden justeret og udviklet. (jyllands-posten.dk 22.1.2016)

(Anm: Forsøgspersoner risikerer altid at dø i kliniske forsøg. Én mand er død, og fem andre indlagt efter at have deltaget i et klinisk forsøg med medicin i Frankrig. Risikoen for at dø i et klinisk forsøg er lige så lav, som hvis man sætter sig ind i en flyvemaskine - men den vil altid være der, siger to danske forskere. (videnskab.dk 19.1.2016).)

- Legemiddelfirmaers rapporter over uheldige hendelser er ofte ufullstendige, ifølge amerikansk rapport

Drug makers’ adverse event reports are often incomplete, US report finds (Legemiddelfirmaers rapporter over uheldige hendelser er ofte ufullstendige, ifølge amerikansk rapport)
BMJ 2015;350:h651 (Published 04 February 2015)
Legemiddelprodusentenes rapporter om uønskede legemiddelhendelser er ofte ufullstendige og mangler grunnleggende informasjon, som f.eks. pasientens alder eller kjønn eller dato for hendelsen, har en amerikansk undersøkelse av en uavhengig sikkerhetsgruppe for legemidler registrert. (Drug manufacturers’ reports of adverse drug events are often incomplete, lacking such basic information as the patient’s age or gender or the date of the event, a US investigation by an independent drug safety group has found.)

Forskere ved Institutt for Safe Medication Practices har sett på kvaliteten på rapportene utarbeidet av den amerikanske legemiddelkontrollen Food and Drug Administrations Adverse Event Reporting System (FAERS) over ett år til første kvartal 2014.1 I løpet av denne perioden ble det innrapportert 847 039 rapporter til systemet, inkludert rapporter om 45 688 pasientdødsfall fra amerikanske kilder og 41 884 dødsfall fra utenlandske kilder. (Researchers from the Institute for Safe Medication Practices looked at the quality of reports made to the US Food and Drug Administration’s Adverse Event Reporting System (FAERS) over one year to the first quarter of 2014.1 During that period 847 039 reports were made to the system, including reports of 45 688 patient deaths from US sources and 41 884 deaths from foreign sources)

FAERS reports come from two main sources: from consumers or healthcare providers, who voluntarily submit reports either directly to the Food and Drug Administration (FDA) or to the drug makers; or from the drug makers, who are required by law to submit reports of any adverse events they learn about to the FDA. Reports from drug makers account for 96.6% of the FAERS reports.

The reports contain a narrative describing the adverse event and its severity. The severity is coded by FDA regulations as resulting in one or more of the following outcomes: death, disability, a birth defect, hospitalization, required intervention to prevent harm, threat to life, or other medically serious consequences.

The investigators found that, while 85% of the reports submitted directly to the FDA from consumers and healthcare providers were “reasonably complete”—which the researchers defined as containing at least the patient’s age and gender and the date of the event—only 49.4% of the reports from drug makers included all of this basic information. In 36% of cases, for example, the patient’s age was not reported, and in 44% the date of the event was omitted.

Kvaliteten på legemiddelprodusentenes rapporter om alvorlige bivirkninger varierte ifølge granskerne mye og de svakeste resultatene ble funnet hos fire firmaer, som innsendte rimelig fullstendige rapporter i bare 15 % eller færre av tilfellene. Ikke én produsent matchet 85 % fullstendighet i rapportene innlevert direkte til FDA, og bare fem av de 74 produsentene (7 %), som som ble analysert, hadde som et minimum rapportert alder og kjønn i 90 % eller mer av sine rapporter om alvorlige bivirkninger. "Samlet sett gjorde produsenter en dårlig jobb ved innsamling av grunnleggende pasient- og hendelsesdata uavhengig av alvorlighetsgraden på hendelsen," konkluderte forskerne . (The quality of drug makers’ reports of serious adverse events varied widely, the investigators found, and the weakest performance was seen in four companies that submitted reasonably complete reports in only 15% or less of cases. Not one manufacturer matched the 85% completeness seen in the reports filed directly to the FDA, and only five of the 74 manufacturers (7%) whose reports were analyzed had reported at least the age and gender in 90% or more of their reports of serious adverse events. “Manufacturers overall did a poor job collecting basic patient and event data regardless of the severity of the event,” the researchers concluded.)

Beslutningstakere for legemidler må også rapportere til FDA når de får vite at en pasient har dødd, noe som skjer oftere nå hvor mange pasienter får legemidler med høy risiko, som bare er tilgjengelige gjennom tett overvåkedede, begrensede distribusjonsprogrammer. Men i 24 939 (28,5 %) av produsentenes 87 572 rapporter om pasientdødsfall "hadde ingen nyttig informasjon om dødsårsaken eller den mulige rolle legemidlet spilte," skriver forskerne. (...) (Drug makers must also report to the FDA when they learn that a patient has died, which happens more frequently now that many patients receive high risk drugs that are available only through closely monitored, restricted distribution programs. However, 24 939 (28.5%) of the manufacturers’ 87 572 reports on patient deaths “had no useful information about the cause of death or possible drug role,” the researchers wrote.)

(Anm: Institute for Safe Medication Practices. A critique of a key drug safety reporting system. QuarterWatch 28 Jan 2015.)

(Anm: Editorials Why data sharing should be the expected norm BMJ 2015;350:h599 (Published 05 February 2015).)

- Spesialrapport på uheldige bivirkninger for fedmelegemidler (fedmemedisiner)

Special Report Download
Comparative Analysis of the Newly Approved Obesity Drug: Contrave

adverseevents.com 28.7.2015
ObesityContraveOn September 10th, the FDA granted approval of a new chronic weight-loss drug, Contrave (naltrexone and bupropion extended-release). Contrave is formulated as a combination product consisting of an opioid antagonist (naltrexone) and an antidepressant (bupropion), both of which are FDA-approved drugs indicated for treating different conditions as individual agents. Several issues pertaining to Contrave’s safety profile raise significant concerns.

This report serves to highlight some of the safety considerations for currently approved obesity treatments as well as compare the safety profiles of Contrave and Qsymia. (…)

(Anm: Endnu et dødsfald efter fedmestudie. Et amerikanske selskab, der er en af Novo Nordisks mulige konkurrenter på markedet for medicinsk behandling af fedme, har oplevet endnu et dødsfald efter et klinisk studie med selskabets hovedaktiv. (medwatch.dk 2.12.2015).)

(Anm: Zafgen - Dedicated to the Treatment of Obesity. (Zafgen.com).)

(Anm: Beloranib is an experimental injectable[1] drug candidate for the treatment of obesity. It was discovered by CKD Pharmaceuticals and is currently being developed by Zafgen.[ (en.wikipedia.org).)

(Anm: Zafgen Says a Second Patient Died in Beloranib Study. FDA had placed beloranib on partial clinical hold in October following first patient’s death. (...) “Our thoughts are with the patient and their family at this time,” he said. “Patient safety remains our top priority, and we are investigating the circumstances around this event.” (wsj.com 3.12.2015).)

(Anm: UPDATED: Beleaguered Zafgen crushed after FDA demands force it to dump lead drug. Stymied at the FDA with a lingering clinical hold on its lead obesity drug, Zafgen is dumping the therapy and retreating to a preclinical program in the pipeline. The biotech announced after the market closed on Tuesday that it will now circle the wagons around ZGN-1061 after beloranib was linked with the death of two patients in a pivotal study. (endpts.com 19.2016.)

– Ekteparet slo alarm om legemiddel: – Deres innsats har sannsynligvis reddet mange liv

Ekteparet slo alarm om legemiddel: – Deres innsats har sannsynligvis reddet mange liv
nettavisen.no 24.7.2014
- Det har vært spennende og uhyre interessant å oppdage noe som ikke har vært kjent tidligere, men barna våre synes nok at det har vært litt slitsomt, sier Friedemann Leh og ler.

Nå har lagemiddelet blitt forbudt i hele Europa.

Det var i mars 2014 at Bergensavisen kom med nyheten om at Statens Legemiddelverk trekker medikamentet Metadon Martindale fra markedet i Norge.

Nå har EMA, Det europeiske legemidddelverket, bestemt at medikamentet skal trekkes fra markedet i alle europeiske land, skriver Bergensavisen

Dette som følge av en oppdagelse av ekteparet Sabine og Friedemann Leh. De jobber som patologer på Haukeland sykehus.

Etter flere mistenkelige vevsprøver slo de alarm tidligere i år.

– 7000 personer i Norge får såkalt LAR-behandling. Disse får medikamenter som Subutex og Metadon mot sin narkotika-avhengighet. Bare i Bergen er det nærmere 1000 pasienter som får LAR-behandling. 3500 av 7000 pasienter får metadon. Rundt en tredjedel av disse igjen, omtrent 1000 personer, har fått Metadon Martindale, sier overlege Sigurd Hortemo ved Statens Legemiddelverk,

Statens legemiddelverk fikk melding om tre dødsfall og alvorlig sykdom hos 13 pasienter som var skadet av povidon-avleiringer i kroppen. Dette skyldes mest sannsynlig injisering av metadon med povidon. (…)

(Anm: Metadon (methadone hydrochloride) - Subotex (buprenorfin) (Buprenorphine). (mintankesmie.no).)

- Dabigatran: hvordan legemiddelfirmaet holdt tilbake viktige analyser

Dabigatran: how the drug company withheld important analyses
BMJ 2014;349:g4670 (23 July 2014)
In an investigation by The BMJ Deborah Cohen finds that recommendations for use of new generation oral anticoagulants may be flawed because regulators did not see evidence showing that monitoring drug plasma levels could improve safety

An investigation by The BMJ shows how the manufacturers of a blockbuster anticoagulant stroke drug withheld from the regulators important analyses regarding how to use the drug as safely and effectively as possible.

Dabigatran is one of a new generation of oral anticoagulants for stroke prevention in patients with non-valvular atrial fibrillation recently recommended in guidelines from the National Institute for Health and Care Excellence for England and Wales.1 Guidelines in the US, Europe, and Canada have similarly recommended these drugs, in part because they don’t require monitoring of plasma levels or anticoagulant activity and subsequent dose adjustment, unlike older treatments such as warfarin.2 3 4

Yet information about dabigatran disclosed through previously confidential internal company documents released during litigation in the US—which they have settled for $650m (£380m; €480m)—and as a result of an investigation by The BMJ, show that the evidence on which these guidelines were based is incomplete.

In fact, Boehringer Ingelheim, the maker of dabigatran, has failed to share with regulators information about the potential benefits of monitoring anticoagulant activity and adjusting the dose to make sure the drug is working as safely and effectively as possible. The company also withheld analyses that calculated how many major bleeds dose adjustment could prevent. The company says that this information was not shared because the analysis did not provide a reliable prediction of patient outcomes.

Anticoagulation is a risky procedure. In the UK, warfarin is one of the drugs most commonly implicated in emergency hospital admissions as a result of major bleeds5 and the drug’s anticoagulant activity is monitored to reduce those risks. (...)

- Studie: Legemiddelutviklere rutinemessig - og uetisk - hemmeligholder forsøksdata

Study: Drug developers routinely--and unethically--leave trial data in the dark (Studie: Legemiddelutviklere rutinemessig - og uetisk - hemmeligholder forsøksdata)
fiercepharma.com 30.10.2013
Drug companies routinely herald their concern for patients as the leading reason why they spend billions of dollars on drug research. But a new study questions Big Pharma's real commitment to its ethical obligations to patients when companies routinely neglect to publish the results of clinical trials.

Close to one in three of all the clinical trials done in the U.S. are left in the dark at least four years after the studies have been completed, note scientists in a new issue of the British Medical Journal. And the vast majority of those trials have no data at all which are publicly available.

Leaving data under cover "violates an ethical obligation that investigators have towards study participants," notes Christopher Jones from the Department of Emergency Medicine at the Cooper Medical School of Rowan University in New Jersey, and colleagues, according to a report in The Guardian. They call for additional safeguards "to ensure timely public dissemination of trial data." (...)

(Anm: Fri tilgang til forskningsresultater? (forskningsdata) (mintankesmie.no).)

(Anm: The hidden side of clinical trials | Sile Lane | TEDxMadrid (youtube.com).)

(Anm: Forvaltningsmakt og kunnskapspolitikk. Sammendrag. Helse- og omsorgsdepartementet benekter at de ønsker å styre forskninga i underliggende etater, og ser ingen problemer med at forskninga ligger under forvaltninga. Rus & Samfunn 05 / 2016 (Volum 9) Side: 33-35.)

(Anm: Frie forskere eller maktens lakeier? Abstrakt. Det går et skisma gjennom den samfunnsvitenskapelige rusforskningen. Ved første øyekast er det vanskelig å forstå hvorfor. Rus & Samfunn 05 / 2016 (Volum 9) Side: 36-40.)

(Anm: Nesten halvparten av alle studier som er gjennomført av store sponsorer i det siste tiåret er upublisert (Nearly half of all trials run by major sponsors in past decade are unpublished.) BMJ 2016;355:i5955 (Published 04 November 2016).)

(Anm: Who's not sharing their trial results? (trialstracker.ebmdatalab.net).)

(Anm: Transparency for patients: How much is too much? (pharmafile.com 11.10.2016).)

(Anm: Parlamentsmedlemmer hører at kliniske forsøk er byråkratiske, uklare, og forvirrende for forskere og pasienter. (…) "Det har vært en rekke kjente tilfeller hvor godkjente legemidler er basert på ufullstendig informasjon — og hvor den informasjonen som senere er stilt til rådighet har vist at legemidlet er ineffektivt eller faktisk skadelig.  (Clinical trials are bureaucratic, opaque, and offputting to researchers and patients, MPs hear.) BMJ 2013;346:f1711 (14 March 2013).)

- Vanligt med opublicerade studieresultat

Vanligt med opublicerade studieresultat
lakemedelsvarlden.se 31.10.2013
Nästan var tredje stor klinisk studie är fortfarande inte publicerad efter fem år. Forskarna menar att det är oetiskt mot studiedeltagarna.

Amerikanska forskare har undersökt hur väl den amerikanska lagen om att kliniska studier ska registreras och resultatet offentliggöras på Clinicaltrials.gov efterföljs. Forskarna identifierade 585 kliniska studier på minst 500 patienter som var registrerade på sajten och avslutade före januari 2009. Uppföljningstiden mellan avslutad studie och publikation var 60 månader.

Av de 585 registrerade studierna var 171, 29 procent, fortfarande opublicerade efter uppföljningstiden på 60 månader. Av de opublicerade studierna hade 78 procent, 133 stycken, inga studieresultat publicerade på Clinicaltrials.gov. Det var vanligare att studier finansierade av läkemedelsindustrin hade opublicerade resultat, 32 procent, än de med annan finansiering, där siffran var 18 procent.

Forskarna menar att opublicerade studier bidrar till att ge en snedvriden bild av resultaten och att det är oetiskt mot studiedeltagarna eftersom de tar en risk då de deltar i kliniska studier. De menar att det behövs ytterligare åtgärder för att säkerställa att resultaten offentliggörs så snart som möjligt.
Studien är publicerad i tidskriften BMJ. Tidskriften är en av initiativtagarna till All Trials-kampanjen, som syftar till att läkemedelsföretagen ska publicera all studiedata, även om resultaten är negativa. (...)

- Forskere uttrykker frykt grunnet etikk på legemiddelforsøk som forblir upubliserte

Scientists voice fears over ethics of drug trials remaining unpublished (Forskere uttrykker frykt grunnet etikk på legemiddelforsøk som forblir upubliserte)
guardian.co.uk 30.10.2013
Almost a third of large clinical trials in the US still not published five years after being finished, scientists write in BMJ

Scientists say about 250,000 people have taken part in unpublished trials and have therefore been exposed to all the risks involved in research without the benefits to society they were led to believe would happen

Drug companies and other organisations that carry out clinical trials are violating their ethical obligation to the people who take part by failing to publish the results, scientists will argue on Wednesday.

Almost one in three (29%) large clinical trials in the United States remain unpublished five years after they are finished, according to scientists writing in the British Medical Journal. Of those, 78% have no results at all in the public domain.

The scientists calculate about 250,000 people took part in the unpublished trials and have therefore been exposed to all the risks involved in research without the benefits to society they were led to believe would ensue. This "violates an ethical obligation that investigators have towards study participants", say Christopher Jones from the Department of Emergency Medicine, Cooper Medical School of Rowan University, New Jersey, and colleagues. They call for additional safeguards "to ensure timely public dissemination of trial data."

The researchers looked at trials registered in the United States, but some of that research will have taken place in Britain and the issue is global.

Drug companies and other organisations with commercial interests have always been reluctant to publish the results of unsuccessful trials and those they think might give useful information to competitors. Academics, too, do not always publish their results.

There has been increasing pressure for all trial results to be made public, especially those funded by the pharmaceutical industry. Concealing a few failures can make a new drug look more effective than it really is or hide side-effects. This led the US to require the registration of all trials and reports of their results on the Clinicaltrials.gov database. But the BMJ paper says the evidence is that the legislation is ignored.

Jones and colleagues looked at 585 trials involving more than 500 volunteers that were completed before January 2009. Five years or more later, 171 were still unpublished and 133 had no results posted on the database at all. Trials funded by industry were more likely not to have been published (32%) than others (18%).

The organisation Sense about Science has been at the forefront of the AllTrials Campaign for full publication. Síle Lane, its director of campaigns, said the US research was very relevant to the UK.

"Clinicaltrials.gov is a global register and the world's largest so it includes trials that were carried out in the UK. Anyway, trials from around the world are used to make UK prescribing decisions. So information from those trials is vital for UK regulators and researchers," she said.

"There's no excuse for not publishing results but a huge public health benefit to having a complete picture of what was found in trials conducted on treatments currently available to patients."

Richard Stephens, a cancer patient and AllTrials campaign supporter, said failing to publish results was a betrayal of people who take part in research. "I have entered five research studies as a participant. I did it for several reasons, but the one motive that runs through every one of them is my belief that by taking part in research I will help other patients in future," he said.

"For that to happen, the results of the research must be made available. Even if the research isn't finished or the results aren't as expected, the data and information are still of value and should be made available.

"I would ask every researcher and every research funder out there to do all they can to make their results available. Patients become participants to add to knowledge and to eliminate uncertainties. Hiding results, no matter what the reason, isn't in that spirit at all. In fact it is a betrayal of our trust."

The House of Commons science and technology committee called for registration and publication of all trials on an accessible database, like that in the USA. Regulation to be debated next week would require all EU clinical trials to be registered and report their summary results within one year of the finish in a publicly accessible EU Clinical Trials Register. (...)

- FDA beskylder biotekselskab for at tilbageholde oplysninger

FDA beskylder biotekselskab for at tilbageholde oplysninger
medwatch.dk 26.6.2012
Amylin har ifølge FDA tilbageholdt vigtige infomationer om bivirkninger forbundet med selskabets diabetesmiddel Bydureon.

De amerikanske sundhedsmyndigheder, FDA, har beskyldt biotekselskabet Amylin for at have tilbageholdt vigtige oplysninger om bivirkninger forbundet med brug af diabetesmidlet Bydureon. Det skriver Financial Times.

I et dokument fra januar, som blev offentliggjort for nyligt, gjorde FDA's ansvarlige for diabetesmedicin opmærksom på forsinkelser, før Amylin fremviste patientresultater relevante både i forhold til diabetesmidlet Byetta og den langtidsvirkende version af samme medicin, Bydureon.

Ifølge FDA har evalueringen fra myndighedernes side været "lang og kompliceret...til dels som følge af, at Amylin har tilbageholdt information om Byetta, som FDA anså for vigtig i sin evaluering af sikkerhed- og effekt af Bydureon". (...)

- Amerikanske advokater undersøker forsøk som sikret lisens for Astrazenecas platehemmende legemiddel

US lawyers investigate trial that secured license for AstraZeneca’s antiplatelet drug (Amerikanske advokater undersøker forsøk som sikret lisens for Astrazenecas platehemmende legemiddel)
BMJ 2013;347:f6727 ( November 2013)
The US Department of Justice is investigating the UK drug company AstraZeneca over a clinical trial that was used to gain marketing approval for its antiplatelet drug ticagrelor (marketed in the United States as Brilinta and in the European Union as Brilique).

The US authorities have asked for documents and information about the Platelet Inhibition and Patient Outcomes (PLATO) trial, published in the New England Journal of Medicine in September 2009.1

This 18 000 participant trial, conducted in 43 countries, reported that ticagrelor with aspirin, when compared with clopidogrel with aspirin, significantly reduced the rate of a composite of deaths from vascular causes, myocardial infarction, or stroke (death rate 9.8% versus 11.7% (hazard ratio 0.84 (95% confidence interval 0.77 to 0.92)).

AstraZeneca said it planned to cooperate with the Department of Justice. Its chief executive, Pascal Soriot, said he was “very confident” in the findings of the drug trial. “It was guided by a strong academic group who oversaw the trial and its conduct,” he told reporters.

Neither the department nor AstraZeneca has specified exactly what aspect of the PLATO trial was being investigated.

The trial had drawn criticism from several sources and led to a rift within the US Food and Drug Administration when it came up for licensing. During the approval process the drug reviewer Thomas Marciniak documented 26 different problematic cases in the trial.

Marciniak noted misrecording of adverse event dates, leading to events not being counted; failure to submit potential adverse events for adjudication; and not counting adverse events because of withdrawal of consent—even though the events occurred before consent was withdrawn.
“In PLATO the missing data for events was about 13%,” Marciniak has told the BMJ. (...)

- Østtyskere brukt som prøvekaniner

Østtyskere brukt som prøvekaniner (dagsrevyen 19.5.2013)
nrk.no 17.5.2013
Legemiddelskandalen ryster Tyskland.

Titusener av innbyggere i det tidligere DDR ble brukt som forsøkspersoner av vestlige legemiddelkonserner på 1980-tallet.

Mange døde av forsøkene viser avsløringer i det tyske medier. I noen av tilfellene ga pasientenes familier sitt samtykke, uten å vite hva de var med på.

Hør mer om legemiddelskandalen i Verden på lørdag

Mer enn 50.000 østtyskere deltok i rundt 600 kliniske tester som ble gjennomført ved et femtitall sykehus i det tidligere Øst-Tyskland, skriver Der Spiegel. Regimet skal ha tjent enorme summer på testene.

De nye avsløringene baserer seg på tidligere ukjente dokumenter fra det østtyske helsedepartementet, farmasøytiske institutter og Stasi-arkivet.

Blant legemidlene som ble prøvd ut, var blodtrykksmedisiner og antidepressiva fra store legemiddelprodusenter i Vest-Tyskland, Sveits og USA.

Mange av deltakerne skal ha mistet livet under forsøkene, og legemidler skal også ha blitt testet på spedbarn og deliriske alkoholikere. (…)

(Anm: Deadly Side Effects: New Details Emerge in East German Drug Test Scandal (spiegel.de 14.5.2013).)

- Novo indrømmer at have skjult to dødsfald

Forsker: Novo skjulte dødsfald
ekstrabladet.dk 12.9.2013
Novo Nordisk undlod at offentliggøre artikler om forsøg, hvor der var registreret dødsfald og bivirkninger i forbindelse med diabetespillen Novo Norm (…)

Novo indrømmer at have skjult to dødsfald
medwatch.dk 12.9.2013
Den danske diabetesgigant Novo Nordisk indrømmer at have skjult to dødsfald i 15 år gamle offentliggjorte artikler omhandlende Novo Norm. Dødsfaldene blev nævnt i interne rapporter.

To dødsfald, der kan have været relateret til Novo Norm, blev skjult i Novo Nordisks offentliggjorte artikler, selvom de figurerede i interne rapporter. Det skriver Ekstra Bladet.

Peter Kristensen, udviklingsdirektør i Novo Nordisk, siger til avisen, at man set i bagklogskabens klare lys kan sige, at de pågældende dengang lavede en forkert vurdering ved at udelade de to dødsfald fra artiklerne. Han henviser til, at det skete for 15 år siden og siger samtidig, at man ville gøre tingene anderledes i dag. (...)

- GlaxoSmithKline sparker forskningssjef i Kina for datasvindel

GlaxoSmithKline's research chief in China fired for data fraud (GlaxoSmithKline sparker forskningssjef i Kina for datasvindel)
fiercepharma.com 11.6.2013
The head of GlaxoSmithKline's R&D operation in China has been fired while another researcher has resigned following a company probe into allegations that company investigators had "misrepresented" data on interleukin-7 research published in Nature Medicine.

News of the allegation of misconduct and the internal probe it inspired has been bubbling around the industry over the past few days, with reports in Pharmalot and other industry pubs. Nature reported that GlaxoSmithKline spokesperson Melinda Stubbee confirmed that Jingwu Zhang at the GlaxoSmithKline Research and Development Center's department of neuroimmunology in Shanghai "originally claimed to have found data suggesting that the signaling molecule interleukin-7 caused a subset of T cells known as T helper 17 (TH17) cells taken from people with multiple sclerosis to multiply. The finding complemented other research in the field suggesting that genetic differences in the cell receptor for interleukin-7 might put some individuals at risk for developing multiple sclerosis--an autoimmune disease thought to involve helper T cells."

Zhang was fired, another unidentified employee resigned and three others were suspended from their jobs pending a final review by the company. (...)

GlaxoSmithKline investigates alleged data fraud involving R&D lab staffers in China
fiercepharma.com 6.6.2013
GlaxoSmithKline ($GSK) has launched a probe of a research study involving its employees from a research lab in Shanghai, China. The investigation follows allegations of fraudulent data in a scientific paper published three years ago in Nature Medicine, with a number of Glaxo scientists listed as co-authors, Pharmalot reported.

The London-based drug giant has jumped into action with the integrity of the research, which focused on the activity of the interleukin-7 protein in autoimmune disease, on the line. As Pharmalot reports, the company has sidelined at least one employee who is on leave. "We can acknowledge that we are carrying out an internal investigation into alleged issues related to a scientific paper. As you know, we take such matters very seriously--the integrity of our research is critical to our work and we are doing whatever is required to investigate these matters fully," Glaxo employees wrote in a memo, as cited by the publication.

"I can confirm that we're carrying out an internal investigation into some alleged issues related to a scientific paper but I don't have further details at the moment--and it wouldn't be appropriate for us comment on particular aspects of an investigation while it's ongoing," a GSK spokeswoman said in a prepared statement sent to FierceBiotech and others. "The integrity of our research is critical to our work and we are giving this our full attention. We'll be in a position to provide more information once the investigation has completed." (...)

- Pasientenes manglende stemme ved rapportering av legemiddelsikkerhet

The Missing Voice of Patients in Drug-Safety Reporting (Pasientenes manglende stemme ved rapportering av legemiddelsikkerhet)
healthcarereform.nejm.org 10.3.2010 (New England Journal of Medicine)
En pasient ønsker å bli informert om hvilke symptomer hun kan få av et legemiddel som inntas. Ved å lese avsnittet “Uheldige reaksjoner” i pakningsvedlegget finner hun et vell av data, men hun er ikke oppmerksom på at denne informasjonen, som i hovedsak er samlet inn i løpet av kliniske forsøk, nesten utelukkende er basert på klinikernes inntrykk av pasienters symptomer — ikke på pasienters rapporteringer av egne erfaringer med legemidlet. (A patient wants to know about symptoms she may have from a prescription drug she is taking. Consulting the label’s “Adverse Reactions” section, she finds a wealth of data. Little does she realize that this information, largely collected during clinical trials, is based almost entirely on clinicians’ impressions of patients’ symptoms — not on patients’ own firsthand reports of their experiences with the drug.)

Den nåværende praksis med pakningsvedlegg for uheldige hendelser er stilltiende basert på den forutsetning at en nøyaktig fremstilling av pasientens subjektive erfaringer alene kan fremskaffes gjennom klinikernes dokumentasjon. Selv om det er en betydelig bevismengde som ikke støtter denne antakelsen, viser det seg at klinikere systematisk undervurderer alvorligheten av pasienters symptomer, at pasienters selvrapporteringer ofte påviser sideeffekter som klinikere overser, og at klinikerne svikter når det gjelder å notere denne type symptomer hvilket resulterer i uheldige hendelser som kunne forebygges.1, 2 (...) (The current drug-labeling practice for adverse events is based on the implicit assumption that an accurate portrait of patients’ subjective experiences can be provided by clinicians’ documentation alone. Yet a substantial body of evidence contradicts this assumption, showing that clinicians systematically downgrade the severity of patients’ symptoms, that patients’ self-reports frequently capture side effects that clinicians miss, and that clinicians’ failure to note these symptoms results in the occurrence of preventable adverse events.1, 2)

(Anm: Legemiddelstudier, åpenhet, uredelighet og kvalitet. (mintankesmie.no).)

(Anm: Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists. BMJ 2011; 342:c7153 (6 January).)

- Forekomsten av ufullstendig rapportering av studieresultater (rapporteringsbias) er høyt

Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists (Hyppighet og årsaker til rapporteringsbias(rapporteringskjevhet) av resultater i kliniske forsøk: intervju med de som utfører forsøk)
BMJ 2011; 342:c7153 (6 January)
Målsetting Å gi informasjon om hyppigheten og årsakene til rapporteringsbias(rapporteringskjevhet) i kliniske forsøk. (...) (Objectives To provide information on the frequency and reasons for outcome reporting bias in clinical trials.)

Konklusjon Forekomsten av ufullstendig rapportering av forsøksresultater er høyt. De som utfører kliniske forsøk (tester) virket generelt uvitende om konsekvensene for kunnskapsgrunnlaget å ikke rapportere alle resultater og protokollendringer. En generell mangel på enighet om valg av resultater i spesielle kliniske settinger var påtagelig, og påvirker forsøksdesign, gjennomføring, analyse og rapportering. (...) (The prevalence of incomplete outcome reporting is high. Trialists seemed generally unaware of the implications for the evidence base of not reporting all outcomes and protocol changes. A general lack of consensus regarding the choice of outcomes in particular clinical settings was evident and affects trial design, conduct, analysis, and reporting.)

(Anm: Bias [baies] -en, - skjevhet i vitenskapelig undersøkelse el. resultat pga. mangelfull systematikk i innsamlingen av data. Etym.: eng., fr. biais helning, tendens. Kilde: ordnett.no.)

(Anm: Bias; (...) valg og vurderinger som på systematisk måte avviker fra det som er faktisk korrekt. Kilde: Store norske leksikon.)

(Anm: Legemiddeletterlevelse (Tas legemidler som foreskrevet?) (Adherence to Medication.) (…) Legemidler virker ikke på pasienter som ikke tar dem. (Drugs don't work in patients who don't take them.)  (NEJM 2005;353:487-497(August 4).)

- Legemiddelforsøk ikke representative, ifølge forskere

Drug Trials Not Representative, Researchers Charge (Legemiddelforsøk ikke representative, ifølge forskere)
medpagetoday.com 27.12.2011
Few major randomized, controlled clinical trials examine the effects of a drug in patients who have multiple chronic conditions, even though more than one-quarter of all Americans are living with at least two chronic health conditions, researchers reported.

The proportion is even greater for older individuals, two out of three of whom are likely to have at least two chronic health conditions, according to Alejandro Jadad, MD, and colleagues from the Centre for Health, Wellness and Cancer Survivorship at the University Health Network in Toronto.

That means that most trials on which the FDA bases its approval of new drugs are not generalizable to the U.S. population, they wrote in a research letter published in the Dec. 28 issue of the Journal of the American Medical Association. (...)

(Anm: Consideration of Multiple Chronic Diseases in Randomized Controlled Trials. JAMA. 2011;306(24):2670-2672 (December 28).)

- Lægemiddelstyrelsen: Det er op til os at stramme krav til industrien

Lægemiddelstyrelsen: Det er op til os at stramme krav til industrien
medwatch.dk 10.2.2012
Det er op til sundhedsmyndighederne selv at udstikke nye, skrappere retningslinjer for, hvordan medicinalselskaberne kan få godkendt deres nye lægemidler, siger chefen i Lægemiddelstyrelsen – medicinalselskaberne følger de spilleregler, der er.

Når medicinalselskaber skal have godkendt lægemidler ved Lægemiddelstyrelsen, vælger de sommetider at sammenligne præparaterne med stoffer, der ikke er de bedste på markedet. Og det skal Lægemiddelstyrelsen tage med i vurderingen, når et lægemiddel står over for godkendelses-folkenes domsfældelse, påpeger Steffen Thirstrup, chef for Godkendelsesafsnittet i Lægemiddelstyrelsen.

”Af og til bliver der i industrien tænkt meget over, hvilket stof man sammenligner sine produkter med. Det er i ikke kun i ansøgninger, der rammer nationalt, men også noget, vi ser, når virksomheder søger markedsføringstilladelse i hele Europa,” siger han.

Angreb på branchen
Kommentaren kommer i kølvandet på en artikel i Information, hvor læger angriber industrien for at fifle med de kliniske forsøg ved at vælge at sammenligne deres nye lægemidler med forældede eller ringeste alternativer på markedet. Det gøres, ifølge kilderne i artiklerne, så virksomheders resultater fremstår stærkere.

Læs også: Avis: Medicinalindustrien sammenligner ny medicin med gamle lægemidler

For at undgå, at nogle virksomheder spekulerer i at sammenligne deres nye lægemidler med forældede produkter, skal der strengere krav til, mener han.
”Det er os, der laver de her guidelines til industrien. Guidelines, der fortæller dem, hvordan de udvikler produkterne” siger Steffen Thirstrup og tilføjer:
”Det kan gøres bedre, det er der ingen tvivl om. Man kan tydeliggøre kravene om at lave sammenligning med et andet aktivt stof og være meget eksplicitte om, hvilket eller hvilke af dem, man som myndighed kunne forestille sig.” (...)

- Utilstrekkelig legemiddelutprøvning

Utilstrekkelig legemiddelutprøvning
Tidsskr Nor Legeforen 2013 (Publisert først på nett 2. juli 2013)
Mange legemidler blir ikke tilstrekkelig testet før de godkjennes av legemiddelmyndighetene.

Europeiske og amerikanske retningslinjer anbefaler at legemidler til langvarig bruk testes av 1 000 – 1 500 individer og bør utprøves hos minst 300 personer i seks måneder og minst 100 personer i 12 måneder før de godkjennes. Forskere har undersøkt om anbefalingene overholdes (1).

200 nye legemidler, derav 84 til langvarig bruk, som var godkjent av det felleseuropeiske legemiddelverket EMA i perioden 2000 – 10 ble evaluert. Mediant antall pasienter i studiene var 1 708 per legemiddel. Retningslinjene for langtidsutprøvning ble overholdt for 80 % av medisinene til langvarig bruk.

– Selv om regelverket i det store og hele følges, viser undersøkelsen at nye legemidler, uansett indikasjon, evalueres i kliniske studier som gjennomgående inkluderer relativt få pasienter som følges over kort tid, sier Lars Slørdal, professor ved Norges teknisk-naturvitenskapelige universitet (NTNU) og overlege ved Avdeling for klinisk farmakologi, St. Olavs hospital. – Dette er tilstrekkelig for å vise at legemidlene har den påståtte effekten, men ofte utilstrekkelig for å vise at legemidlene er trygge. Sikkerhetsaspektet blir enda mer problematisk når vi vet at de pasientene som inngår i slike studier vanligvis skiller seg fra målgruppene, bl.a. ved å være yngre, ikke ha andre sykdommer og ikke bruke andre legemidler. – Få pasienter i en klinisk studie innebærer økt risiko for ubehagelige overraskelser senere. Den beste måten å beskytte seg mot slikt er å velge «gamle» legemidler med en velkjent effekt- og bivirkningsprofil. Legemiddelmyndighetene burde dessuten vært mer aktive i rollen som samfunnets dørvokter i legemiddelsikkerhetsspørsmål. I dag ser det ut til at industriens interesser tillegges for stor vekt, sier Slørdal. (...)

(Anm: Number of patients studied prior to approval of new medicines: a database analysis. PLoS Med. 2013;10(3):e1001407. Epub 2013 Mar 19.)

- Skjulte dødbringende bivirkninger: 50 døde efter medicin-løgn

Skjulte dødbringende bivirkninger: 50 døde efter medicin-løgn
b.dk 5.7.2011
Medicinalfirmaet GE Healthcare har holdt alvorlige bivirkninger ved et medicinsk præparat skjulte for danske læger og myndigheder. I dag er cirka 100 patienter blevet ramt af alvorlig sygdom og 50 af dem er døde. Det skriver B.T. tirsdag.

Det drejer sig om produktet Omniscan, der er et kontrastmiddel, som sprøjtes ind i kroppen på patienter, der skal røntgenfotograferes. Omniscan har vist sig at kunne påføre patienter med svage nyrer den stærkt invaliderende og ofte dødbringende sygdom, nefrogen systemisk fibrose (NSF). Der er ingen behandling.

B.T. er i besiddelse af dokumenter fra det amerikanske advokatfirma "The John Restaino Law Firm", som dokumenterer at GE Healthcare i 1989 og 1992 udførte forsøg med rotter og kaniner. De ellers raske dyr blev syge af produktet, skriver B.T. (...)

Socialdemokraternes sundhedsordfører Sophie Hæstorp Andersen er også i besiddelse af de nye oplysninger.

- Jeg er dybt chokeret. Det er ondsindet. Når man på den måde sætter penge højere end de patienter, som man skal behandle, så er det fordi, firmaet har onde hensigter, siger hun.

Hun vil nu rejse sagen politisk og arbejde for at noget lignende aldrig sker igen.

GE Healthcare svarer skriftligt til B.T., at de mener at produktets fordele opvejer ulemperne. (...)

De myrdede mor
b.dk 5.7.2011
Maria mistede sin mor til Omniscan

Maria Rye Dahl mistede sin mor og Jørgen Dahl sin kone til kontrastoffet Omniscan. Nu er der kommet nye oplysninger om at producenten kendte til de dødbringende bivirkninger, inden det kom på markedet. (...)

Kriminelt
- Jeg savner min mor hver dag. Men noget af det, som jeg har det dårligst med, er faktisk, at det lykkedes dem at komme igennem med det produkt. At det bare gik igennem systemet. Det må aldrig ske igen. Der skal tydeligvis være en bedre kontrolinstans, der undersøger alle de data, som firmaet ligger inde med, siger Maria.

Jørgen Dahl håber, at indenrigs- og sundhedsminister Bertel Haarder følger op på de nye oplysninger og sikrer sig, at firmaer ikke længere kan holde oplysninger skjult på den måde, som det er sket i Omniscan-tilfældet.

- Jeg håber, at de vil være interesserede i at få det opklaret. Det er jo kriminelt. Noget af den værste slags, som man kan forestille sig, siger Jørgen Dahl. (...)

- Svindel og humbug: Forskere pillede ved resultater af personlig kræftmedicin

Duke Scientist Suspended Over Rhodes Scholar Claims
nytimes.com 20.7.2011
Duke University School of Medicine has suspended a researcher and stopped patient enrollment in three cancer studies upon learning of reports that the researcher had overstated his academic credentials. (...)

The controversy erupted late last week after an article published in The Cancer Letter, a weekly publication for cancer specialists, reported that Dr. Potti, an assistant professor of medicine, had on occasion exaggerated his credentials. (A spokeswoman at Rhodes House at Oxford confirmed on Tuesday that Dr. Potti had not received the scholarship.)

When questions about Dr. Potti’s credentials became public, the American Cancer Society suspended payments of a five-year, $729,000 grant awarded to Dr. Potti to study the genetics of lung cancer. The society awarded the grant based in part on a résumé from the doctor that included the Rhodes honor, said Dr. Otis W. Brawley, the chief medical officer of the cancer society.

Dr. Potti did not respond to an e-mail message seeking comment. (...)

(Anm: Four Cancer Genomics Papers Retracted From Top Journals (medscape.com 4.3.2011).)

Svindel og humbug: Forskere pillede ved resultater af personlig kræftmedicin
ing.dk 14.7.2011
Løgn om akademisk hædersbevis afslørede, at amerikanske forskere i årevis har givet kræftpatienter virkningsløs behandling med medicin målrettet med gentest.

En sag om videnskabelig uredelighed ryster i øjeblikket amerikanske kræftforskere, efter det er kommet frem, at Doktor Anil Potti fra medicinskolen på Duke Universitet ikke bare øjensynligt har løjet om sine videnskabelige hædersbevisninger, men at han tilsyneladende også har manipuleret med forskningsresultater og behandlet patienter med ubrugelig medicin i årevis.

Blandt andre den amerikanske avis New York Times har dækket skandalen.

Ifølge avisen fik Doktor Anil Potti og hans kolleger i 2006 offentliggjort en videnskabelig artikel i det prestigiøse tidsskrift Nature Medicine. I artiklen beskrev forskerne en metode, de havde udviklet, som kunne hjælpe læger med at vælge den helt rigtige kemobehandling til en bestemt patient på baggrund af genom test, der beskriver kræftsvulstens molekylære opbygning.

En anden kræftforsker, doktor John Minna fra Texas Universitet, forskede også i området. Han bad to statistikere om at se på resultaterne i den offentliggjorte artikel, og statistikerne fandt omgående fejl. Forskerne fra Duke Universitetet affejede dog fejlene som betydningsløse. (...)

- Forsker hevder studie overdrev nytte av antidepressiva

Paxil study under fire (Seroxat-studie angripes)
Nature 2011;475, 153 (Published online 12 July)
Trial researcher alleges paper exaggerated antidepressant benefits. (Forsker hevder studie overdrev nytte av antidepressiva)

The contentious issue of drug-industry influence over medical-research writing erupted on the campus of the University of Pennsylvania in Philadelphia this week. A professor of psychiatry has alleged that several colleagues — including the chair of his department — allowed their names to be added to a manuscript while ceding control to the global pharmaceutical giant GlaxoSmithKline (GSK). The professor, Jay Amsterdam, also claims that the manuscript, written with an unacknowledged contractor paid by GSK, unduly promotes the company's antidepressant drug Paxil (paroxetine), the subject of the study.

"The published manuscript was biased in its conclusions, made unsubstantiated efficacy claims and downplayed the adverse-event profile of Paxil," Amsterdam's lawyer wrote in an 8 July letter to the Office of Research Integrity (ORI), the body responsible for investigating research misconduct in US Public Health Service agencies and its grant recipients.

Amsterdam had recruited patients for the trial but was not included as an author; he protested at the time to his boss, department chair Dwight Evans. Amsterdam was prompted to file his current complaint with the ORI after seeing allegations late last year that Evans had lent his name to an editorial (D. L. Evans and D. S. Charney Biol. Psychiatr. 54, 177–180; 2003) written by an STI writer who was being paid by GSK (the payment was not acknowledged in the publication). At the time, the university decided that the allegation of ghostwriting was unfounded.

The letter accuses the study's academic authors of engaging in scientific misconduct by allowing their names to be attached to the manuscript (C. Nemeroff et al. Am. J. Psychiatr. 158, 906–912; 2001), which has been cited more than 250 times. Documents accompanying Amsterdam's complaint are offered as evidence that "most if not all" of the authors were handpicked by GSK, working in conjunction with the medical-communications company Scientific Therapeutics Information (STI) in Springfield, New Jersey, to lend credibility to a result that Amsterdam says places Paxil in an overly favourable light. In one such document, Karl Rickels, a psychiatrist not involved with the study who looked at the issue for the department in 2001 said that "apparently … [academic] participants never had a chance to review or even just see the manuscript before it went to press". (...)

The five authors whom Amsterdam accuses are Evans, Charles Nemeroff, now chairman of psychiatry at the University of Miami in Florida; Laszlo Gyulai, a psychiatrist at the University of Pennsylvania who has now retired; Gary Sachs, a psychiatrist at Massachusetts General Hospital in Boston; and Charles Bowden, a clinical professor of psychiatry and pharmacology at the University of Texas Health Science Center in San Antonio. (...)

- Varslere felte Glaxosmithkline (GSK)

Whistleblowere tjener tykt på GSK-svindel
medwatch.dk 4.7.2012
De fire tidligere ansatte, der gik til myndighederne med deres viden om markedsføringssvindel i GSK står nu til at dele et gigantisk beløb som tak for hjælpen.

Fire tidligere ansatte i det britiske medicinalselskab Glaxosmithkline, GSK, er blevet særdeles holdne, efter at deres beviser har hjulpet de amerikanske myndigheder til at afsløre markedsføringssvindel med GSK-medikamenterne Paxil og Wellbutrin i perioden 1998-2003 samt manglende sikkerhedsinformationer omkring diabetesmidlet Avandia i perioden 2001-2007. Det skriver Bloomberg News.

De fire tidlige ansatte, Greg Thorpe, Blair Hamrick, Thomas Gerathy og Matthew Burke, står nu til at dele 159 mio. pund - eller knap 1,5 mia. kr. - svarende til godt 8 pct. af den sum på 3 mia. dollar, som GSK skal betale for den fejlagtige markedsføring.

Gammel amerikansk lovgivning fra tiden omkring borgerkrigen giver nemlig whistleblowere adgang til en andel af de penge, som staten henter i svindelsager. (...)

(Anm: Seroxat (Paxil) (paroxetine; paroksetin) (SSRI) (mintankesmie.no).)

(Anm: GlaxoSmithKline whistleblower speaks out about bribery of doctors, off-label marketing of drugs (GlaxoSmithKline-varsleren snakker ut om bestikkelser av leger, markedsføring av legemidler utenfor preparatomtale) (youtube.com 23.7.2012).)

GlaxoSmithKline is fined record $3bn in US (GlaxoSmithKline er ilagt rekordbot på 3 milliarder dollar i USA)
BMJ 2012;345:e4568 (3 July)
GlaxoSmithKline har inngått avtale om å erkjenne skyld og betale 3 milliarder dollar (£ 2 milliarder, € 2,4 mrd) i straff for ulovlig markedsføring av reseptbelagte legemidler, unnlatelse av å rapportere sikkerhetsdata og falsk prisrapportering. (GlaxoSmithKline has agreed to plead guilty and pay $3bn (£2bn; €2.4bn) in penalties for unlawful promotion of prescription drugs, failure to report safety data, and false price reporting.)

Det er også inngått en 123 siders avtale om bedriftens integritet med det amerikanske justisdepartementet som regulerer firmaets aktiviteter de neste fem årene.1 (...) (It also signed a 123 page corporate integrity agreement with the US Department of Justice that regulates its activity for the next five years.1)

GSKs avtale omfatter flere av dets ledende legemidler. De markedsførte ulovlig antidepressivaet Seroxat (paroxetine / fornorsket paroksetin) for behandling av pasienter under 18 år, selv om Food and Drug Administration (legemiddelkontrollen) aldri godkjent legemiddel for denne aldersgruppen. Firmaet har også utarbeidet "villedende" tidsskriftartikler som hevder Seroxat hadde effekt for denne befolkningsgruppen når "studien ikke viste effekt,« Det amerikanske justisdepartementet sa i sin kunngjøring at de skjulte studier som hadde negative funn.3 (GSK’s agreement covers several of the its leading drugs. It illegally promoted the antidepressant paroxetine for treating patients under the age of 18, even though the Food and Drug Administration never approved the drug for that age group. The company also created “misleading” journal articles claiming efficacy of paroxetine in that population, when in fact “the study failed to demonstrate efficacy,” the justice department said in its statement, and it hid trials that had negative findings.3)

GSK markedsførte ulovlig bupropion for vekttap, seksuell dysfunksjon, substansavhengighet, og ADHD (oppmerksomhetssvikt-hyperaktivitets-syndromet) og annen bruk utenfor preparatomtale. De brukte også "falske rådgivende styrer, og tilsynelatende uavhengig medisinsk etterutdanning, (CME) programmer," og store bestikkelser i forbindelse med reiser for å fremme uautorisert bruk av legemidler. (...) (GSK illegally promoted bupropion for weight loss, sexual dysfunction, substance addictions, and attention-deficit/hyperactivity disorder and other off-label uses. It also used “sham advisory boards, and supposedly independent continuing medical education (CME) programs,” and lavish travel inducements to promote unauthorised uses of the drug.)

(Anm: Antidepressiva (nytteverdi) (mintankesmie.no).)

(Anm: Ny forskning: Lykkepiller gør mere skade end gavn. Folk med depression får intet ud af at tage antidepressivet SSRI, bedre kendt som lykkepiller, viser nyt dansk studie. (jyllands-posten.dk 13.2.2017).)

(Anm: Forskere finner link mellom bruk av antidepressiva, medfødte misdannelser eller dødfødsler. (Researchers Find Link Between Antidepressant Use, Congenital Anomalies or Stillbirths) (…) "Mens denne ekstra risikoen kan virke liten er resultatene etter mitt syn så alvorlig som de kan være." (“While this extra risk may seem small, in my view, the outcomes are as serious as they can be.”) (dgnews.docguide.com 5.12.2016).)

(Anm: Eksponering av foster for antidepressiva kan endre Corpus Callosums mikrostruktur: Presentert ved PAS / ASPN. (…) Fordi "den neonate (nyfødtes) corpus callosum mikrostruktur er assosiert med utero (livmor) SSRI-eksponering og prenatal (før fødsel) mødredepresjon, er tidlige modningsprosesser i denne regionen følsomme for endret 5-hydroksytryptamin (5-HT) signalering under tiden i utero (livmor)," bemerket Campbell. "Disse resultatene - sammen med forstyrret hvit substans’ mikrostruktur i genu hos premature spedbarn - tyder dette på at utviklingen av [corpus callosum] kan være følsom for tidlige uheldige påvirkninger. (Fetal Exposure to Antidepressants May Alter Corpus Callosum Microstructure.) (dgnews.docguide.com 10.5.2017).)

(Anm: Unormal sæd med SSRI antidepressiva. Flere studier har funnet endrede sædparametere etter eksponering for SSRI-antidepressiva. Selv om SSRIs rolle er usikker, er det berettiget å ta hensyn til de observerte effektene på sædkvalitet og informere eksponerte pasienter. (Semen abnormalities with SSRI antidepressants. Several studies have found altered semen parameters after exposure to SSRI antidepressants. Although the role of SSRIs is uncertain, it is justified to take into account the observed effects on sperm quality and to inform exposed patients.) Prescrire Int 2015; 24 (156): 16-17.)

(Anm: Gravide kvinner som tar antidepressiva er mer sannsynlig å få barn med autisme, ifølge studie. Pregnant women who take antidepressants more likely to have a child with autism, study finds. Research data published in the BMJ reveal that antidepressant use during pregnancy increases the risk of autism in children, as reported The Independent Thursday. (firstwordpharma.com 20.7.2017).)

(Anm: - Nye data viser økt risiko for misdannelser når antidepressiva brukes under graviditet. (…) En studie publisert i British Medical Journal (BMJ) avslører at antidepressiva forskrevet til gravide kan øke sjansen for å få en baby med misdannelser.) (New Data Show Heightened Risk of Birth Defects When Antidepressants Are Used During Pregnancy.) (dgnews.docguide.com 19.1.2017).)

(Anm: - Utviklingen av et potensielt livstruende serotonergt syndrom eller nevroleptisk malignt syndrom (NMS)-lignende reaksjoner er rapportert for SNRI-er og SSRI-er alene, inkludert Celexa-behandling, men spesielt ved samtidig bruk av serotonerge legemidler (inklusive triptaner) og legemidler som svekker metabolisme av serotonin (inklusive MAO-hemmere), eller med antipsykotika eller andre dopaminantagonister (fda.gov 6.3.2009).)

(Anm: Antidepressant use during pregnancy and the risk of major congenital malformations in a cohort of depressed pregnant women: an updated analysis of the Quebec Pregnancy Cohort. (…) Conclusions Antidepressants with effects on serotonin reuptake during embryogenesis increased the risk of some organ-specific malformations in a cohort of pregnant women with depression. BMJ Open 2017;7:e013372.)

(Anm: Bruk av antipsykotika er assosiert med en 60 % økt risiko for dødelighet hos pasienter med Alzheimers sykdom. (…) Bruk av to eller flere antipsykotika samtidig ble knyttet til nesten doblet dødsrisiko (200 %) enn ved monoterapi.) (Antipsychotic Drug Use Increases Risk of Mortality Among Patients With Alzheimer’s Disease. JOENSUU, Finland -- December 12, 2016 -- Antipsychotic drug use is associated with a 60% increased risk of mortality among patients with Alzheimer's disease, according to a study published in the Journal of Alzheimer’s Disease. The risk was highest at the beginning of drug use and remained increased in long-term use. Use of 2 or more antipsychotic drugs concomitantly was associated with almost 2 times higher risk of mortality than monotherapy.) (dgnews.docguide.com 12.12.2016).)

(Anm: Antipsykotika dobler dødsrisiko allerede etter 180 dagers bruk. Greater Mortality Risk With Antipsychotics in Parkinson's (Større dødsrisiko med antipsykotika ved Parkinsons) (medicalnewstoday.com 21.6.2015).)

(Anm: (...) For ytterligere å illustrere problemet kan nevnes at antipsykotika forårsaker parkinsonisme (5), og en studie fant at mennesker med Parkinsons sykdom og psykose hadde fire ganger større sannsynlighet for å dø etter tre til seks måneders behandling enn de som ikke fikk antipsykotika. (6) De var også mer utsatt for kognitiv svikt, forverring av parkinsonsymptomer, hjerneslag, infeksjoner og fall. RE: Psykisk syke lever kortere. Tidsskr Nor Legeforen 10.11.2015.)

(Anm: Legemidler som kan gi delirium hos eldre. Delirium ses særlig hos eldre ved akutte sykdommer og skader eller som følge av toksisk eller farmakologisk påvirkning. Eldre personer har mange sykdommer og bruken av legemidler er høy. Mange legemidler, og særlig de med antikolinerg eller dopaminerg effekt, kan gi delirium. Kjennskap til legemidler og kombinasjoner av legemidler som kan gi delirium, er viktig for å kunne forebygge og behandle tilstanden. Tidsskr Nor Legeforen 2005; 125:2366-7 (8.9.2005).)

(Anm: Delirium in hospitalized patients: Risks and benefits of antipsychotics. ABSTRACT Consensus panel guidelines advocate for the judicious use of antipsychotic drugs to manage delirium in hospitalized patients when nonpharmacologic measures fail and the patient is in significant distress from symptoms, poses a safety risk to self or others, or is impeding essential aspects of his or her medical care. Here, we review the use of haloperidol, olanzapine, quetiapine, risperidone, and aripiprazole for this purpose. Cleveland Clinic Journal of Medicine. 2017 August;84(8):616-622.)

(Anm: Post injektionssyndrom. (…) De fleste af disse patienter udviklede symptomer på sedation (fra mild sedation til koma) og/eller delirium (herunder forvirring, desorientering, ophidselse/ uro, angst og anden kognitiv svækkelse). Andre symptomer inkluderede ekstrapyramidale symptomer, dysartri, ataksi, aggression, svimmelhed, svaghed, hypertension eller krampe.) (sundhedsstyrelsen.dk 29.6.2014).)

(Anm: Mødre til børn med misdannelser har øget dødelighed. (…) Bivirkninger har ført til to dødsfald. Den største del af bivirkningerne (42 procent) af de 429 blev indberettet for såkaldte psykostimulerende lægemidler - eksempelvis til behandling af ADHD - efterfulgt af 31 procent for antidepressiver og 24 procent for antipsykotiske lægemidler. (videnskab.dk 20.12.2016).)

(Anm: Antikolinerge effekter av vanlige legemidler knyttet til økt dødelighet hos mennesker over 65. De kombinerte antikolinerge effektene av mange vanlige legemidler øker risikoen for kognitiv svekkelse og død hos personer over 65 år, ifølge resultater fra en storskala studie på den langsiktige helseeffekten av legemidler.(Anticholinergic effects of common drugs are associated with increased mortality in over 65s. The combined anticholinergic effects of many common drugs increase the risk of cognitive impairment and death in people aged over 65, a large scale study of the long term effect of drugs on health has found.) BMJ 2011; 342:d4037 (28 June).)

(Anm: Men experience greater cognitive impairment and increased risk of death following hip surgery. In a study of hip fracture patients, men displayed greater levels of cognitive impairment within the first 22 days of fracture than women, and cognitive limitations increased the risk of dying within six months in both men and women. "While men make up only about 25 percent of all hip fractures, the number of men who fracture their hip is increasing and we know men are more likely to die than women after a hip fracture," said Dr. Ann Gruber-Baldini, lead author of the Journal of the American Geriatrics Society study. (medicalnewstoday.com 10.2.2017).)

(Anm: Det autonome nervesystemet. Det autonome nervesystemets hovedoppgave er å bidra til likevekt i kroppens basale funksjoner. Det vil blant annet si kroppstemperatur, blodtrykk, åndedrett og fordøyelse. (nhi.no 4.3.2015).)

(Anm: Ulike selektive serotonin reopptakshemmeres (SSRI-er) cytotoksisitet mot kreftceller. (Cytotoxicity of different selective serotonin reuptake inhibitors (SSRIs) against cancer cells.) (…) Vi har funnet at paroxetine (paroksetin; Seroxat; Paxil etc.) har cytotoksisk aktivitet mot tumorceller. J Exp Ther Oncol. 2006;6(1):23-9.)

(Anm: Could antidepressants stop prostate cancer from spreading? In almost all cases where prostate cancer spreads to other areas of the body, the disease spreads to the bone first. In a new study, researchers reveal the discovery of an enzyme that helps prostate cancer cells to invade bone. Furthermore, certain antidepressant medications may have the potential to block this enzyme. Study co-author Jason Wu, of Washington State University-Spokane, and colleagues recently reported their findings in the journal Cancer Cell. (medicalnewstoday.com 13.3.2017).)

(Anm: Classic cytotoxic drugs: a narrow path for regulatory approval. Several classic cytotoxic drugs have shown encouraging activity in the treatment of metastatic breast cancer.1–3 However, only a few have received an overwhelming welcome from regulatory authorities and succeeded in obtaining widespread regulatory approval for routine use. For example eribulin was approved for treatment of metastatic breast cancer in several countries including Japan, USA, and Europe, based on data that showed longer overall survival in patients treated with eribulin compared with patients treated with physician's choice of treatment. In contrast ixabcpilone with capecitabine gained approval from the US Food and Drug Agency based on data showing longer progression-free survival compared with capccitabine alone, but did not obtain rcgulatory authorisation in Europc because it is associated with a high incidence of nevropathy.5 Lancet Oncol. 2017 Feb 10. pii: S1470-2045(17)30089-X. [Epub ahead of print].)

(Anm: Ødelagt cellulær "klokke" linket til hjerneskade (Broken Cellular 'Clock' Linked to Brain Damage) (sciencedaily.com 25.11.2013).)

(Anm: Signaling Pathways Linked to Serotonin-Induced Superoxide Anion Production: A Physiological Role for Mitochondria in Pulmonary Arteries. Abstract. Serotonin (5-HT) is a potent vasoconstrictor agonist and contributes to several vascular diseases including systemic or pulmonary hypertension and atherosclerosis. Although superoxide anion ([Formula: see text]) is commonly associated to cellular damages due to [Formula: see text] overproduction, we previously demonstrated that, in physiological conditions, [Formula: see text] also participates to the 5-HT contraction in intrapulmonary arteries (IPA). Front Physiol. 2017 Feb 9;8:76. eCollection 2017.)

(Anm: Bruk av antidepressiva ble assosiert med et betydelig eldre utseende og forskere fant også ut at vekten spilte en viktig faktor. I de sett med tvillinger som var yngre enn 40 år ble tyngre tvillinger oppfattet som eldre. (…) I tillegg mistenker forskerne at den vedvarende avslapping av ansiktsmuskler som antidepressiva forårsaker kan forklare årsaken til at ansiktet faller sammen (henger). (mintankesmie.no).)

(Anm: Minislag (ministroke: transient ischemic attack (TIA)) linket til lavere forventet levetid. (- Minislag kan forårsake demens.) (- Enkelte psykofarmaka kan øke risiko for minislag / demens.) (mintankesmie.no).)

(Anm: Stumme infarkt rammer oftere folk med høy smertetoleranse. Stumme hjerteinfarkt gir ikke de klassiske brystsmertene som ved vanlige infarkt. - Denne pasientgruppen tar enten ikke kontakt med lege, eller de har ikke fått riktig diagnose, sier lege og forsker Andrea Milde Øhrn. (…) Det er vanlig å tenke sterke brystsmerter og akutt behandling når det er snakk om hjerteinfarkt. Det mange kanskje ikke vet, er at man kan ha hatt et hjerteinfarkt uten å vite det. Dette kalles et stumt infarkt, et hjerteinfarkt med få eller ingen symptomer. - Et stumt hjerteinfarkt er et hjerteinfarkt som ikke er erkjent. (nhi.no 3.2.2017).)

(Anm: Sannsynlig karotidyni forårsaket av fluoxetine (Prozac; SSRI-er). (Probable fluoxetine-induced carotidynia.)  Karotidyni er en fokal nakkesmerte (bestemt, avgrenset område), som involverer anatomiske områder til den berørte arteria carotis, og stråler ofte ut i den ipsilateral side (samme side) av ansiktet eller øret. På grunnlag av medisinsk historie og alder har karotidyni konvensjonelt vært klassifisert i klassisk (ikke-migrenøs), migrenøs, og vaskulære varianter. The Lancet 2009;374(9695):1061-1062 (26 September).)

(Anm: Nakkesmerter sætter forskerne skakmat. Kroniske nakkesmerter koster samfundet milliarder og er en af de hyppigste årsager til, at danskere melder sig syge fra job. Forskerne er i vildrede: Ingen behandling er effektiv. (videnskab.dk 22.12.2016).)

(Anm: Antidepressiva linket til hjerterisiko: tvillingstudie. (Antidepressants linked to heart risk: twins study) - Middelaldrende menn som bruker antidepressiva er mer sannsynlig å ha en innsnevring av blodårer, noe som øker risikoen for hjerteinfarkt og slag, enn de som ikke bruker legemidlene, ifølge en studie presentert på lørdag. (Reuters) - Middle-age men who use antidepressants are more likely to have a narrowing of blood vessels, increasing the risk of heart attacks and strokes, than those who do not use the medications, according to a study presented on Saturday.) (reuters.com 2.4.2011).)

(Anm: - Pfizers Zyvoxid (Zyvox) og antidepressiva kan være en dødelig kombinasjon. (- Det antas at når linezolid gis til pasienter, som behandles med serotonerge psykofarmaka, kan forhøyede nivåer av serotonin bygge seg opp i hjernen og forårsake toksisitet (giftighet). Dette er referert til som Serotonin syndrom - tegn og symptomer inkluderer mentale endringer (forvirring, hyperaktivitet, minneproblemer), muskelrykninger, overdreven svetting, skjelving eller risting, diaré, problemer med koordinasjon og / eller feber.) (fda.gov 21.10.2011).)

(Anm: Hva er det forskrivere og pasienter ikke vet om bivirkninger av antidepressiva? (What do prescribers and patients not know about the side effects of antidepressant drugs?) (medicalnewstoday.com 15.9.2016).)

(Anm: Forskere: Alvorlige bivirkninger, når antidepressiver droppes. Angst, depression og selvmordstanker er nogle af de bivirkninger, som tit forekommer, når man holder op med at tage antidepressiv medicin. Bivirkningerne kan i nogle tilfælde være langvarige og kroniske, viser et nyt studie. (videnskab.dk 16.3.2015).)

(Anm: Bruk av visse smertestillende midler (og antidepressiva (+ 31 %)) forbundet med økt risiko for drap (Use of certain painkillers linked with increased risk of homicide) Enkelte legemidler som påvirker sentralnervesystemet - som smertestillende og beroligende benzodiazepiner - er assosiert med økt risiko for å begå et drap, finner en ny studie publisert i tidsskriftet World Psychiatry. (medicalnewstoday.com 1.6.2015).)

(Anm: Psykiatriske patienter ender i private botilbud. Drab og vold har de seneste år fyldt debatten om de danske bosteder for patienter med psykiske problemer. (…) Psykiatriske patienter ender i private botilbud. (…) Mens Folketinget kæmper for en løsning på problemet med vold på offentlige bosteder, vælger flere kommuner at sende tunge patienter til private tilbud. (politiken.dk 18.3.2017.)

(Anm: Aggresjon knyttet til økt risiko for substansmisbruk. Aggression disorder linked to greater risk of substance abuse. (…) In the study, published in the Journal of Clinical Psychiatry, Emil Coccaro, MD, and colleagues analyzed data from more than 9,200 subjects in the National Comorbidity Survey, a national survey of mental health in the United States. They found that as the severity of aggressive behavior increased, so did levels of daily and weekly substance use. The findings suggest that a history of frequent, aggressive behavior is a risk factor for later substance abuse, and effective treatment of aggression could delay or even prevent substance abuse in young people. (medicalnewstoday.com 2.3.2017).)

(Anm: Halvparten av norske drap begått av rusede. (…) I 125 av drapene – eller 54 prosent – er det beskrevet i dommen at gjerningspersonen var påvirket av rusmidler under drapet. (nrk.no 13.12.2016).)

- En pasient på UNN døde av blodforgiftning som følge av et legemiddel mot psykiske lidelser, opplyser Statens helsetilsyn.

(Anm: En pasient på UNN døde av blodforgiftning som følge av et legemiddel mot psykiske lidelser, opplyser Statens helsetilsyn. (- Pasienten døde etter kort tid, og dødsårsaken var nøytropen sepsis (blodforgiftning), heter det i tilsynets rapport. (nrk.no 12.10.2016).)

(Anm: Systemic inflammatory response syndrome (SIRS) is an inflammatory state affecting the whole body, frequently a response of the immune system to infection. (en.wikipedia.org).)

(Anm: Sepsis. Definisjon: SIRS + påvist/mistenkt infeksjon (f. eks. positiv blodkultur). SIRS- kriteriene er: - Feber > 38 ºC eller hypotermi < 36 ºC - Puls > 90/minutt - Respirasjonsfrekvens > 20/minutt eller hypokapni med pCO2 < 4,3 kPa i blodgass - Leukocytose ≥ 12 × 109/l eller leukopeni < 4 × 109/l eller > 10 % umodne leukocytter. (helsebiblioteket.no - Metodebok for indremedisinere, 2012).)

(Anm: Rollen til mitokondriell dysfunksjon (mitokondriedysfunksjon) ved sepsis (blodforgiftning)-indusert multiorgansvikt. (The role of mitochondrial dysfunction in sepsis-induced multi-organ failure). (Virulence. 2013 Nov 1;5(1).)

- Diagnostisering av sepsis. Sepsis, også kjent som blodforgiftning, er kroppens hyperaktive respons på en infeksjon som kan føre til betennelse, vevskader, organsvikt etc.

(Anm: Diagnosing Sepsis. Sepsis, also known as blood poisoning, is the body’s hyperactive response to an infection that can lead to inflammation, tissue damage, organ failure etc. It is a very dangerous state in which the immune system stops fighting with the invading agents  and turns to itself. Around one-third of patients who are affected with sepsis die every year. (news-medical.net 7.9.2017).)

- Å anerkjenne sepsis som en global helseprioritet - En WHO- resolusjon.

(Anm: Å anerkjenne sepsis som en global helseprioritet - En WHO- resolusjon. Recognizing Sepsis as a Global Health Priority — A WHO Resolution. “Some very important clinical issues, some of them affecting life and death, stay largely in a backwater which is inhabited by academics and professionals and enthusiasts, dealt with very well at the clinical and scientific level but not visible to the public, political leaders, leaders of healthcare systems... The public and political space is the space in which [sepsis] needs to be in order for things to change.” NEJM (June 28, 2017).)

(Anm: Sepsis – den dödliga sjukdomen som glöms bort. Trots att infektionssjukdomen sepsis förekommer oftare än de vanligaste formerna av cancer och att upp emot hälften som drabbas av den allvarligaste formen dör, så har många knappt hört talas om sjukdomen. Sepsis som är den medicinska termen på blodförgiftning, drabbar omkring 40 000 svenskar varje år. (netdoktor.se 7.6.2017).)

- Hurtigtest finner tegn på sepsis i en enkelt dråpe blod.

(Anm: Hurtigtest finner tegn på sepsis i en enkelt dråpe blod. (- Sepsis, en potensielt livstruende komplikasjon av en infeksjon, har den høyeste byrde mht. død og medisinske utgifter på sykehus over hele verden.) (- Quick test finds signs of sepsis in a single drop of blood. (…) Sepsis, a potentially life-threatening complication of an infection, has the highest burden of death and medical expenses in hospitals worldwide. (medicalnewstoday.com 5.7.2017).)

(Anm: Nye sepsiskriterier kan føre til forsinket behandling. (…) Sepsis er en svært alvorlig tilstand med høy morbiditet og mortalitet (2). Den totale insidensen er ukjent, men man regner med at sepsis er en av de viktigste årsakene til alvorlig, akutt sykdom på verdensbasis (1). (…) Sepsis har inntil nylig vært definert som mistenkt infeksjon med samtidig tilstedeværelse av to eller flere SIRS-kriterier (1). Endringer i hjertefrekvens, kroppstemperatur, respirasjonsfrekvens og leukocytter er kroppens tegn på inflammasjon, og de indikerer ikke nødvendigvis en livstruende, dysregulert vertsrespons på infeksjon. Tidsskr Nor Legeforen 2017; :609-10 (20.4.2017).)

(Anm: LEGENE FORSTO IKKE AT HAN VAR DØDSSYK: Stian (19) døde etter 18 timer på sykehus uten legetilsyn. (…) Helsetilsynet konkluderer med at sykehusets behandling var uforsvarlig. (…) Fikk ikke beskjed. (…) Fastlegen sendte med dem papirer som foreldrene leverte på Akuttmottaket ved Ahus, der sto det; «Diagnose: Obs sepsis».  (tv2.no 29.4.2017).)

(Anm: Svikt i behandlingen av akutt syk ung mann i akuttmottaket – brudd på helselovgivningen. (…) Pasienten ble lagt på observasjonsposten (Akutt 24) ved akuttmottaket frem til neste morgen. I løpet av tiden på observasjonsposten ble han ikke tilsett av lege. På morgenen var han betydelig verre og han fikk tegn på fullt utviklet blodforgiftning. Behandling med antibiotika ble iverksatt, men han døde kort tid etter som følge av meningokokksepsis og hjerneødem. (helsetilsynet.no 2.5.2017).)

(Anm: Sepsis; grunnleggende kliniske observasjoner. Sepsis= En systemisk inflammatorisk respons (SIRS) pga. en infeksjon Tre alvorlighetsgrader: 1) Sepsis (to eller flere symptomer på SIRS som følge av infeksjon) 2) Alvorlig sepsis (sepsis med akutt organdysfunksjon, hypoperfusjon eller hypotensjon) 3) Septisk sjokk (hypotensjon til tross for adekvat væsketerapi, samt forekomst av perfusjonsforstyrrelser og organdysfunksjon) (hnt.no 5.11.2013).)

- Alle bryt lova i behandling av blodforgifting. Pasientar med alvorleg blodforgifting (sepsis) blir undersøkt av lege for seint.

(Anm: Alle bryt lova i behandling av blodforgifting. Pasientar med alvorleg blodforgifting blir undersøkt av lege for seint. Helsetilsynet fann brot ved 24 akuttmottak over heile landet. – Svært alvorleg. – Dette er svært alvorleg, for det dreier seg om ein alvorleg infeksjonssjukdom som i verste fall kan medføra død dersom behandlinga ikkje blir igangsett til riktig tid, seier avdelingsdirektør i Helsetilsynet, Ragnar Hermstad. OVER EIN TIME: Pasientar som kjem inn med teikn på alvorleg infeksjonssjukdom som blodforgifting skal ifølge nasjonale retningslinjer få anitibiotikabehandling innan maks ein time. Alle dei 24 akuttmottaka hadde svikt på dette området. (nrk.no 16.6.2017).)

(Anm: Lege sier improvisert «kur» for sepsis har hatt bemerkelsesverdige resultater. (…) Spesialist i intensivbehandling Paul Marik sier at enkel behandling med infusjon av vitamin C og steroider har bemerkelsesverdig effekt på pasienter med potensielt dødelig tilstand. (independent.co.uk 24.3.2017).)

(Anm: Bivirkninger underrapporteres i videnskabelige tidsskrifter. (...) Mellem 43 og 100 procent af de bivirkninger, der, ifølge det ikke-publicerede materiale, er fundet ved de testede lægemidler, er ikke lagt frem i de videnskabelige artikler, viser Yoon Loke og kollegernes gennemgang. (videnskab.dk 5.10.2016).)

(Anm: Dødsfall på grunn av nøytropen sepsis (blodforgiftning) etter behandling med legemiddelet klozapin – uforsvarlig oppfølging – mangelfull samhandling og informasjon. (…)  Manglende informasjon fra spesialisthelsetjenesten og mangelfull samhandling mellom kommunehelsetjenesten, fastlegen, pasienten og pårørende bidro til hendelsen. Helseforetaket skal gjennomgå hendelsen for å redusere risikoen ved lignende tilfeller. (helsetilsynet.no 12.10.2016).)

(Anm: Eksplosjon av antidepressiva til unge jenter. De ønsker psykologhjelp. I stedet blir de fôret med piller fra fastlegen. Unge jenter har aldri brukt mer antidepressiver. (vg.no 10.9.2016).)

(Anm: Flere barn og unge akuttinnlegges for psykisk sykdom. I fjor utgjorde andelen øyeblikkelig hjelp innleggelser 61 prosent av alle innleggelser. Det er en økning fra 47 prosent i 2012. (dagensmedisin.no 19.9.2016).)

(Anm: Eksplosjon av antidepressiva til unge jenter: Lykkepillegenerasjonen. «Lykkepillen» gjorde Sandra så dårlig at hun ble innlagt på psykiatrisk avdeling. På ti år har bruken av antidepressiver blant unge jenter økt med 83 prosent. Mange får pillene uten en gang å ha snakket med psykolog.  (vg.no 10.9.2016).)

(Anm: Helseminister Bent Høie reagerer på «lykkepille»-praksis: – Veldig urovekkende. ** Kraftig økning i antidepressiva til unge jenter. Helseminister Bent Høie reagerer på den sterke økningen i lykkepillebruk blant unge jenter. Han mener manglende ressurser og fastlegers holdninger er årsaker. Lørdag dokumenterte VG Helg og VG+ konsekvensene av den økende lykkepille-bruken blant unge jenter. (vg.no 10.9.2016).)

(Anm: LO advarer mot trygdebombe. En stadig større del av nordmenn i arbeidsfør alder er uten jobb. LO mener dette er en potensiell trygdebombe. (…) Det trengs 180.000 nye jobber for å få yrkesdeltakelsen opp på samme nivå som i 2008, viser en rapport fra samfunnsøkonomene i LO. I 2008 var 70 prosent av befolkningen mellom 15 og 74 år i jobb. Nå er yrkesdeltakelsen nede i 67,3 prosent., og det er nedgang i alle fylker. (hegnar.no 6.10.2016).)

(Anm: Rekordmange søger akut psykisk hjælp. (- Mens kun 12.099 danskere i 1995 besøgte de psykiatriske akutmodtagelser og skadestuer, er det steget til hele 33.333 i 2015, viser opgørelse fra Sundhedsdatastyrelsen og Danske Regioner, der for kort tid siden blev sendt til Folketinget. (politiken.dk 9.7.2016).)

(Anm: Har vi blitt psykisk sykere? (- Vi vet også at stadig flere får uførepensjon på grunn av psykiske lidelser og at sykefraværet på grunn av psykiske plager og lidelser har økt. Vi tror alle disse forholdene bidrar til vår oppfatning om at stadig flere får en psykisk lidelse eller plage.) (Folkehelseinstituttet fhi.no 10.10.2013).)

(Anm: Høyt fravær på grunn av ME. Minst 270 elever var borte fra skolen i fjor fordi de hadde ME. (aftenposten.no 6.2.2017).)

(Anm: Psykisk ohälsa fortsätter att öka. Antalet svenskar som sjukskrivs på grund av psykisk ohälsa ökar kontinuerligt sedan 2010. Den vanligaste diagnosen är stressrelaterad psykisk ohälsa som till mångt och mycket är arbetsrelaterad. Då evidensbaserad behandling saknas står förebyggande arbete i fokus. (netdoktor.se 14.9.2016).)

(Anm: Psykiatriske skadestuer kan ikke klare presset. Psykiske lidelser hører til nogle af de største sygdomsbyrder, som hvert år koster samfundet et svimlende milliardbeløb i tabt arbejdsfortjeneste og sociale ydelser. (politiken.dk 11.7.2016).)

(Anm: - 9 ting som skjer i hjernen og kroppen på MDMA (Ecstasy). (- 9 Things That Happen in the Brain and Body on MDMA.) (- Derfor, når substansen avsluttes, sitter mennesker igjen med mindre serotonin enn vanlig, noe som kan føre til følelser av depresjon, irritabilitet og tretthet.) (- Siden MDMA frigir så mye serotonin, ødelegger kroppen deretter mer serotonin enn vanlig, ifølge AsapSCIENCE.) (thescienceexplorer.com 24.6.2016).)

(Anm: Risk of Angle-Closure Glaucoma With Bupropion and Topiramate. (…) Conclusions and Relevance: Both bupropion and topiramate are widely prescribed drugs. The risk of angle-closure glaucoma in patients younger than 50 years was twice as high in patients taking bupropion and more than 5 times higher in patients taking topiramate.JAMA Ophthalmol. 2015 Jul 9. [Epub ahead of print].)

(Anm: Can your brain control how it loses control. A new study may have unlocked understanding of a mysterious part of the brain -- with implications for neurodegenerative conditions such as Alzheimer's. The results, published in Translational Vision Science & Technology (TVST), open up new areas of research in the pursuit of neuroprotective therapies. Glaucoma is a neurodegenerative disease where patients lose seemingly random patches of vision in each eye. This random pattern of vision loss is in stark contrast to loss from a brain tumor or stroke, which causes both eyes to develop blind spots in the same location. Scientists have long thought that glaucoma's progression is independent of - or uncontrolled by - the brain. (medicalnewstoday.com 17.8.2015).)

- Et raskt økende antall straffesaker og sivile pengebøter mot legemiddelindustrien

Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry: 1991 to 2010 (Et raskt økende antall straffesaker og sivile pengebøter mot legemiddelindustrien: 1991 til 2010)
citizen.org 16.12.2010
View entire report as pdf. (...)

(...) USAs utgifter til reseptbelagte legemidler har økt fra 40 milliarder i 1990 til 234 milliarder dollar i 2008. I denne tiden med sterkt økende legemiddelkostnader har legemiddelfirmaers ulovlige aktiviteter bidratt til så store utgifter at det har fått betydelig medieoppmerksomhet. Nylige forlik i størrelsen milliarder av dollar med to av de største legemiddelfirmaer i verden, Eli Lilly og Pfizer, gir beviser på det enorme omfanget av ulovligheter. Imidlertid er den totale størrelsen, den varierende karakter, og eventuelle konsekvenser av denne ulovlige og potensielt farlige virksomhet, ikke tidligere blitt analysert. Denne studien viser trender fra 1991 til i dag for føderale og statlige straffesaker og sivile aksjoner mot legemiddelfirmaer for å adressere disse spørsmålene. (U.S. spending on prescription drugs has increased from $40 billion in 1990 to $234 billion in 2008. In this era of rapidly rising drug costs, the illegal pharmaceutical company activities that have contributed to such inflated spending have garnered a significant amount of media attention. Recent billion-dollar settlements with two of the largest pharmaceutical companies in the world, Eli Lilly and Pfizer, provide evidence of the enormous scale of this wrongdoing. However, the total size, varied nature, and potential impact of these illegal and potentially dangerous activities have not been previously analyzed. This study examined trends from 1991 to the present in federal and state criminal and civil actions against pharmaceutical companies in order to address these questions.)

Analysis
Hensikten med denne studien var å utarbeide en omfattende database over alle store straffesaker og sivile bosettinger mellom føderale og statlige myndigheter og legemiddelfirmaer. Pressemeldinger fra både føderale og statlige myndigheter, i tillegg til eksisterende elektroniske databaser, ble brukt til å identifisere alle forlikene på minst 1 million dollar i løpet av de siste 20 årene. (...) (The purpose of this study was to compile a comprehensive database of all major criminal and civil settlements between federal and state governments and pharmaceutical companies. Press releases from both federal and state governments, in addition to existing online databases, were used to identify all settlements of at least $1 million during the past 20 years.)

- Psykiater dømt til drøyt 8 års fengsel for svindel bl.a. i Seroxat-forsøk

Maria Carmen Palazzo: Debarment Order (Maria Carmen Palazzo: Kjennelse om utelukkelse)
federalregister.gov 28.3.2011
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Maria Carmen Palazzo, M.D. from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Palazzo was convicted of felonies under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product or otherwise relating to the regulation of any drug product under the FD&C Act. Dr. Palazzo was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. (...)

FDA's finding that debarment is appropriate is based on the felony convictions referenced herein for conduct relating to the development or approval, including the process for development or approval, of any drug product and otherwise relating to the regulation of any drug product under the FD&C Act. The factual basis for those convictions is as follows: Dr. Palazzo was a licensed medical doctor with offices located in New Orleans, Louisiana. SmithKline Beecham, Corporation, d.b.a. GlaxoSmithKline (SKB) was a pharmaceutical company engaged in developing, testing, and marketing pharmaceutical products including Paroxetine, also known as “Paxil.” Under the FD&C Act and its implementing regulations, SKB had to apply to FDA for approval to market Paxil. SKB was required to demonstrate, through clinical investigations in which Paxil was given to human subjects, the safety and effectiveness of the drug in order to receive approval from FDA. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Paxil Researcher Pleads Guilty to Charges (Seroxat-forsker erklærer seg skyldig i anklager)
lawyersandsettlements.com 2.9.2010
Washington, DC: GlaxoSmithKline er gjenstand for mer dårlig publisitet etter at en forsker angivelig har forfalsket data i forsøk på Seroxat (Paxil). Samtidig er legemiddelfirmaet saksøkt grunnet påstander om at nyfødte er påført fødselsskader grunnet eksponering for Seroxat (Paxil) i svangerskapet. (Washington, DC: GlaxoSmithKline is the subject of more bad publicity after a researcher was allegedly found to have falsified data in trials about Paxil. Meanwhile, the drug maker faces lawsuits alleging newborns suffered Paxil Birth defects when they were exposed to Paxil prior to birth.)

The psychiatrist who reportedly falsified clinical data, Dr. Maria Carmen Palazzo, was a clinical investigator on studies conducted by SmithKline Beecham (doing business as GlaxoSmithKline). According to CNBC on 8/20/10, Palazzo has now pleaded guilty to 15 counts of failing to prepare and maintain records with the intent to defraud and mislead.

Palazzo reportedly included children in a study that involved diagnoses the children did not have. Prosecutors claimed that Palazzo also reported symptoms that her study subjects did not exhibit. She was sentenced to 13 months in prison, which she is serving at the same time as an 87-month term for healthcare fraud.

Ifølge BNET (08/19/10) ble Palazzo anklaget av den amerikanske legemiddelkontrollen FDA (Federal Drug Administration) for hennes innrullering av barn i studier med tvangslidelser (OCD) og tyngre depressive lidelser til tross for at barna hun undersøkte ikke hadde en egnet diagnose for inkludering i studien. (According to BNET (08/19/10), Palazzo was charged after the Federal Drug Administration (FDA) accused her of enrolling children in studies of obsessive-compulsive disorder and major depressive disorder even though the children she studied did not have the proper diagnosis for inclusion in the study.)

Paxil now carries a black box warning about the risk of suicide in children. It also carries a warning about the risk of birth defects in babies exposed to the antidepressant prior to birth. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Jailed psychiatrist pleads guilty (Fengslet psykiater erkjenner seg straffeskyldig)
cnbc.com 20.8.2010
NEW ORLEANS – En 58 år gammel psykiater involvert i to kliniske forsøk som evaluerte legemidlet Seroxats (Paxils) sikkerhet og effekt hos barn og ungdommer har i forbindelse med disse kliniske forsøk erkjent seg straffeskyldig på 15 statlige tiltalepunkter for manglende utarbeidelse og oppfølging av protokoller, med den hensikt å bedra og villede. (NEW ORLEANS - A 58-year-old psychiatrist involved in two clinical trials evaluating the drug Paxil's safety and effectiveness in children and adolescents has pleaded guilty to 15 federal counts of failing to prepare and maintain records, with intent to defraud and mislead, in connection with those clinical trials.)

Dr. Maria Carmen Palazzo var klinisk forsker hos SmithKline Beecham som utførte arbeider under GlaxoSmithKline. Aktorene sa at hun i løpet av disse studier inkluderte psykiatriske diagnose uten overensstemmelse med pasienters psykiatriske historier; utarbeidet atskillige psykiatriske evalueringer på studiedeltakere som inneholdt forskjellige diagnoser og rapporterte symptomer hun visste studiedeltakerne ikke hadde. (Dr. Maria Carmen Palazzo was a clinical investigator for SmithKline Beecham doing business as GlaxoSmithKline. Prosecutors say that during those studies she included psychiatric diagnoses inconsistent with patients' psychiatric histories; prepared multiple psychiatric evaluations on study patients which contained different diagnoses and reported symptoms she knew the study subject did not demonstrate.)

Hennes tilståelse kom torsdag for den amerikanske distriktsdommeren Mary Ann Vial Lemmon, som dømte henne til 13 måneders fengsel. Denne tiden løper samtidig som hun soner en fengselsdom på 87-måneders for svindel innen helsevesenet. (...) (She entered the plea Thursday before U.S. District Judge Mary Ann Vial Lemmon, who sentenced her to 13 months in prison. That term will run at the same time as her current 87-month prison term for health care fraud.)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

(Anm: Uredelighet og fusk (juks/forskningsjuks) i medisinsk forskning. (mintankesmie.no).)

JAILED PSYCHIATRIST PLEADS GUILTY AND IS SENTENCED ON CHARGES OF FALSIFIED RECORDS OF CLINICAL TRIALS INVOLVING CHILDREN (FENGSLET PSYKIATER ERKLÆRER SEG SKYLDIG OG ER DØMT FOR ANKLAGER OM FORFALSKNING AV JOURNALER FOR KLINISKE FORSØK SOM INVOLVERER BARN)
justice.gov 19.8.2010
DR. MARIA CARMEN PALAZZO, age 58, pled guilty in federal court today before U. S. District Judge Mary Ann Vial Lemmon to fifteen (15) counts of failing to prepare and maintain records, with intent to defraud and mislead, in connection with clinical trials to evaluate the efficacy and safety of Paxil in children and adolescents with Obsessive-Compulsive Disorder (OCD), announced U. S. Attorney Jim Letten.

According to court documents, PALAZZO, who specialized in psychiatry, was a clinical investigator for SmithKline Beecham d/b/a GlaxoSmithKline, was involved in two clinical trials evaluating Paxil’s safety and effectiveness in children and adolescents. Some of the study records indicated that PALAZZO included psychiatric diagnoses inconsistent with patients’ psychiatric histories; prepared multiple psychiatric evaluations on study patients which contained different diagnoses and treatment plans; reported symptoms of OCD when PALAZZO knew that the study subject did not demonstrate such symptoms; and reported that PALAZZO examined study subjects when she had not.

PALAZZO is currently serving an 87 month prison sentence after being convicted of 39 counts of health care fraud following a 12-day trial in April 2008. In the instant case, PALAZZO was sentenced to thirteen (13) months in prison to run concurrent to the previous sentence as well as serve one (1) year of supervised release during which time she will be under federal supervision and risk additional imprisonment should she violate any rulesof the release. Additionally, PALAZZO was ordered to pay restitution to GlaxoSmithKline in the amount of $91,824 and $1,500 in special assessments.

The case was investigated by the Food and Drug Administration’s Office of Criminal Investigations, U. S. Department of Health and Human Services, Office of Inspector General, the Federal Bureau of Investigation and the Louisiana Medicaid Fraud Control Unit.

The case was prosecuted by Assistant U. S. Attorney Patrice Harris Sullivan, the Health Care Fraud Coordinator in this District.

(Download Factual Basis) (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

10 Years Later, Glaxo Still Haunted by Faked Studies of Paxil in Kids (Glaxo 10 år senere fortsatt hjemsøkt av forfalskede studier på Seroxat hos barn)
bnet.com 19.8.2010
A crooked doctor who faked data in a GlaxoSmithKline (GSK) study of the antidepressant Paxil in children pled guilty to criminal charges today, causing groans among GSK’s senior management as the company hopes to fend off a different criminal investigation into whether it manipulated clinical data on its diabetes drug, Avandia. She was sentenced to 13 months in prison. (...) (A crooked doctor who faked data in a GlaxoSmithKline (GSK) study of the antidepressant Paxil in children pled guilty to criminal charges today, causing groans among GSK’s senior management as the company hopes to fend off a different criminal investigation into whether it manipulated clinical data on its diabetes drug, Avandia. She was sentenced to 13 months in prison.)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Psychiatrist indicted for fraud in Paxil trials (Psykiater anklaget for svindel i Seroxat-forsøk)
dailycomet.com 14.6.2007
NEW ORLEANS Dr. Maria Carmen Palazzo was indicted by a federal grand jury on 55 counts of health care fraud and false documentation in connection with a clinical trial of Paxil in children and adolescents, U.S. Attorney Jim Letten said on Thursday. (...)

According to the indictment, Palazzo, as a clinical investigator for SmithKline Beecham doing business as GlaxoSmithKline, fraudulently failed to maintain and prepare records required by the FDA for evaluation the drug's safety and effectiveness in children and adolescents.

If convicted, Palazzo faces a maximum term of 445 years, and a fine of $10.15 million, Letten's office said. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Seroxats 5-årige rettssak-historie

Paxil Five-Year Litigation History (Seroxats 5-årige rettssak-historie)
opednews.com 14.10.2006
It would be difficult to find a better career than employment as a GlaxoSmithKline attorney, especially if job security is a top priority. Not a year goes by when the company is not doling out millions of dollars to defend against charges involving corporate misconduct of one kind or another.

A limited review of the company's involvement in the legal system over just the last five years reveals a clear pattern of habitual corruption. However, although Glaxo has paid billions of dollars in accumulated fines, penalties and awards to plaintiffs in civil cases, not one company official has been arrested and charged with a crime. (...)

Senator stiller spørsmål om GlaxoSmithKlines (GSK) bivirkningsinformasjon

Sen. Grassley Letter to Pharmaceutical Drug Maker About Notice of Drug Trial Findings (Senator Grassleys til legemiddelprodusent om bemerkninger til konklusjoner i legemiddelforsøk)
pharmalive.com 6.2.2008
WASHINGTON, February 6, 2008 - Sen. Chuck Grassley is asking drug maker GlaxoSmithKline for documents regarding the antidepressant medication Paxil. Sen. Grassley is making his request based on a review of documents recently made public and reported today in the magazine New Scientist. (...)

The publicly available portions of the report on Paxil that is missing nine pages is posted at http://finance.senate.gov along with this press release. (...)

(Anm: Grassley Press (finance.senate.gov).

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

En fortiet legemiddelstudie skaper rabalder

A Silenced Drug Study Creates An Uproar (En fortiet legemiddelstudie skaper rabalder)
washingtonpost.com 18.3.2009
The study would come to be called "cursed," but it started out just as Study 15.

It was a long-term trial of the antipsychotic drug Seroquel. The common wisdom in psychiatric circles was that newer drugs were far better than older drugs, but Study 15's results suggested otherwise.

As a result, newly unearthed documents show, Study 15 suffered the same fate as many industry-sponsored trials that yield data drugmakers don't like: It got buried. It took eight years before a taxpayer-funded study rediscovered what Study 15 had found -- and raised serious concerns about an entire new class of expensive drugs.

Study 15 was silenced in 1997, the same year Seroquel was approved by the Food and Drug Administration to treat schizophrenia. The drug went on to be prescribed to hundreds of thousands of patients around the world and has earned billions for London-based AstraZeneca International -- including nearly $12 billion in the past three years.

The results of Study 15 were never published or shared with doctors, even as less rigorous studies that came up with positive results for Seroquel were published and used in marketing campaigns aimed at physicians and in television ads aimed at consumers. The results of Study 15 were provided only to the Food and Drug Administration -- and the agency has strenuously maintained that it does not have the authority to place such studies in the public domain. (...)

- Publikasjonbias (publikasjonsskjevhet) i forsøk på antidepressiva og antipsykotika

Antipsychotic Clinical Trials & Exaggerated Benefits (Kliniske antipsykotika-forsøk og overdrivelse av nytte)
pharmalot.com 21.3.2012
Yet another instance of alleged publication bias has emerged. Four years ago, a review of unpublished studies submitted to the FDA by various drugmakers found many antidepressants had little or no effect on patients. How so? Selective reporting nearly doubled the apparent proportion of positive trials, exaggerating the benefits and, presumably, influencing patient treatment (back story).

Now, a review was conducted of antipsychotics and a somewhat similar finding is being reported in PLoS Medicine. A trio of researchers from Oregon Health & Science University examined 24 premarketing trials registered with the FDA for Abilify, Fanapt, Zyprexa, Invega, Seroquel, Risperdal, Consta and Geodon. The results from the FDA documents were then compared with results published in medical journals.

What did they find? The researchers discovered four premarketing trials were submitted to the FDA - two involving Abilify, which is sold by Bristol-Myers Squibb, and another involving Geodon, which is marketed by Pfizer - but these were never published. And three failed to show either study drug had a statistical advantage over placebo. (...)

(Anm: Publication Bias in Antipsychotic Trials: An Analysis of Efficacy Comparing the Published Literature to the US Food and Drug Administration Database
PLoS Med 2012;9(3): e1001189 (March 20
).)

(Anm: Bias [baies] -en, - skjevhet i vitenskapelig undersøkelse el. resultat pga. mangelfull systematikk i innsamlingen av data. Etym.: eng., fr. biais helning, tendens. Kilde: ordnett.no.)

(Anm: Bias; (...) valg og vurderinger som på systematisk måte avviker fra det som er faktisk korrekt. Kilde: Store norske leksikon.)

(Anm: Legemiddeletterlevelse (Tas legemidler som foreskrevet?) (Adherence to Medication.) (…) Legemidler virker ikke på pasienter som ikke tar dem. (Drugs don't work in patients who don't take them.)  (NEJM 2005;353:487-497(August 4).)

(Anm: Publication bias is a type of bias occurring in published academic research. It occurs when the outcome of an experiment or research study influences the decision of the researcher whether to publish (or otherwise distribute) it. (en.wikipedia.org).)

Farlige følger av publikasjonsskjevhet
Tidsskr Nor Lægeforen 2004; 124:1499 (3.6.2004)
En analyse som inkluderer upubliserte data, viser at selektive serotoninreopptakshemmere ikke er effektive ved depresjon hos barn. Studien viser hvordan publikasjonsskjevhet kan føre til uriktig informasjon om legemidler.

Depresjon forekommer hyppig hos barn og ungdom, og selvmord er en av de vanligste dødsårsakene i denne aldersgruppen. Derfor er behovet for effektiv behandling stort.

I USA har flere typer selektive serotoninreopptakshemmere (SSRI) vært godkjent ved depresjon hos barn og unge. Også i Norge har slike medikamenter vært brukt på denne indikasjonen.

En reanalyse av tilgjengelige studier viser imidlertid at bare fluoksetin hadde en positiv effekt (1). Ved andre typer selektive serotoninreopptakshemmere, samt for venlafaxin, var risikoen ved bruk av medikamentet større enn nytten. Studien inkluderte upubliserte data fremlagt for amerikanske helsemyndigheters komité for godkjenning av legemidler. (...)

(Anm: Bias [baies] -en, - skjevhet i vitenskapelig undersøkelse el. resultat pga. mangelfull systematikk i innsamlingen av data. Etym.: eng., fr. biais helning, tendens. Kilde: ordnett.no.)

(Anm: Bias; (...) valg og vurderinger som på systematisk måte avviker fra det som er faktisk korrekt. Kilde: Store norske leksikon.)

(Anm: Legemiddeletterlevelse (Tas legemidler som foreskrevet?) (Adherence to Medication.) (…) Legemidler virker ikke på pasienter som ikke tar dem. (Drugs don't work in patients who don't take them.)  (NEJM 2005;353:487-497(August 4).)

(Anm: Publication bias is a type of bias occurring in published academic research. It occurs when the outcome of an experiment or research study influences the decision of the researcher whether to publish (or otherwise distribute) it. (en.wikipedia.org).)

Publication Bias in Antipsychotic Trials: An Analysis of Efficacy Comparing the Published Literature to the US Food and Drug Administration Database (Publikasjonbias i forsøk på antipsykotika: En analyse av effektivitet ved sammenligning av den publiserte litteraturen i databasen til den amerikanske legemiddelkontrollen Food and Drug Administration)
PLoS Med 2012;9(3): e1001189 (March 20)
Background
Publication bias compromises the validity of evidence-based medicine, yet a growing body of research shows that this problem is widespread. Efficacy data from drug regulatory agencies, e.g., the US Food and Drug Administration (FDA), can serve as a benchmark or control against which data in journal articles can be checked. Thus one may determine whether publication bias is present and quantify the extent to which it inflates apparent drug efficacy. (...)

Conclusions
The magnitude of publication bias found for antipsychotics was less than that found previously for antidepressants, possibly because antipsychotics demonstrate superiority to placebo more consistently. Without increased access to regulatory agency data, publication bias will continue to blur distinctions between effective and ineffective drugs. (...)

Editors' Summary - Background
People assume that, when they are ill, health-care professionals will ensure that they get the best available treatment. But how do clinicians know which treatment is likely to be most effective? In the past, clinicians used their own experience to make such decisions. Nowadays, they rely on evidence-based medicine—the systematic review and appraisal of trials, studies that investigate the efficacy and safety of medical interventions in patients. Evidence-based medicine can guide clinicians, however, only if all the results from clinical trials are published in an unbiased manner. Unfortunately, “publication bias” is common. For example, the results of trials in which a new drug did not perform better than existing drugs or in which it had unwanted side effects often remain unpublished. Moreover, published trials can be subject to outcome reporting bias—the publication may only include those trial outcomes that support the use of the new treatment rather than presenting all the available data. (...)

(Anm: Bias [baies] -en, - skjevhet i vitenskapelig undersøkelse el. resultat pga. mangelfull systematikk i innsamlingen av data. Etym.: eng., fr. biais helning, tendens. Kilde: ordnett.no.)

(Anm: Bias; (...) valg og vurderinger som på systematisk måte avviker fra det som er faktisk korrekt. Kilde: Store norske leksikon.)

(Anm: Legemiddeletterlevelse (Tas legemidler som foreskrevet?) (Adherence to Medication.) (…) Legemidler virker ikke på pasienter som ikke tar dem. (Drugs don't work in patients who don't take them.)  (NEJM 2005;353:487-497(August 4).)

(Anm: Publication bias is a type of bias occurring in published academic research. It occurs when the outcome of an experiment or research study influences the decision of the researcher whether to publish (or otherwise distribute) it. (en.wikipedia.org).)

Newer Anti-Psychotic Drugs May be Less Effective (Nyere antipsykotika kan være mindre effektive)
ivanhoe.com 21.3.2012
(Ivanhoe Newswire) – If you’re in pain, there’s a pill for that! But it may not always be good. A new study shows clinical effectiveness of the newer form of drugs used to treat schizophrenia and other psychotic illnesses may be enhanced by a phenomenon called publication bias.

The study, led by Erick Turner from Oregon Health & Science University in Portland, shows selective reporting of research results undermines the integrity of the evidence base, which ultimately deprives clinicians of accurate date for prescribing decisions.

The authors reached these conclusions by reviewing 24 FDA-registered premarketing trials for eight second-generation antipsychotics – aripiprazole, iloperidone, olanzapine, paliperidone, quetiapine, risperidone, long-acting injection, and ziprasidone – and then comparing these trials with the results conveyed in subsequent articles in medical journals.

They found that four premarketing trials submitted to the FDA remained unpublished and that all of the unpublished trials showed negative results – three showed the new anti-psychotic had no statistically significant advantage over placebo, and in one trial the new drug was statistically inferior to a much less expensive competing drug.

In the published trials, there was some evidence that the journal articles over-emphasized efficacy of the new drug. For example, the FDA review revealed that one of the newer drugs, iloperidone, was statistically inferior to three different drugs, but this information was not mentioned in the corresponding journal articles.

On the other hand, when the authors used meta-analysis to combine trial data and compare all eight drugs to placebo, they found that publication bias had little effect on their overall apparent efficacy. Of more concern was that some negative data remain unreported, potentially misleading clinicians.

"With further studies investigating publication bias in other drug classes, a more accurate evidence base can emerge. To that end, increased access to FDA reviews has been advocated. At the present time, the FDA is not as transparent with its clinical trial data as it could be," the authors were quoted saying.

However, "it is encouraging that the FDA has convened a Transparency Task Force. If the agency fulfills its mission to increase transparency, the public health will surely benefit," they said. (...)

- Merck hemmeligholdt dødsrisiko

Hemmeligholdt dødsrisiko
forskning.no 17.4.2008
Et legemiddelfirma hemmeligholdt risikoen ved en ny medisin. Tester som ble fremstilt som uavhengige, var skrevet av selskapet selv. - Trolig ikke et unikt tilfelle, sier en norsk professor. (...)

Siden har det vist seg at flere titalls tusen amerikanere kan ha dødd av Vioxx. I Norge ble dødstallet anslått til et hundretalls personer.

Nå viser det seg at Merck & Co., lenge før legemiddelet ble trukket tilbake i 2004, var klar over den høye dødsrisikoen bruk av legemiddelet medførte. (...)

- Studiene bekrefter noen antakelser om den farmasøytiske industrien, der store pengeinteresser er på spill, sier professor i etikk, Knut W. Ruyter, ved Forskningsetiske komiteer. (...)

Studien viser at vitenskapelige artikler som ble fremstilt som uavhengige, i realiteten var skrevet av ansatte ved Merck & Co. (...)

Spøkelsesforfattere
Fenomenet omtales som "ghostwriting", fordi de som egentlig har skrevet studien, er "usynlige" for offentligheten og helsemyndighetene. (...)

I følge de amerikanske forskerne har det lenge vært mistenkt at en slik praksis med "spøkelsesforfattere" er relativt utbredt innenfor biomedisinsk publisering. (...)

(Anm: Legemiddelkonsulenter. (mintankesmie.no).)

(Anm: Spøkelsesforfattere (ghostwriters). (mintankesmie.no).)

Merck dolde fakta om dödlig medicin
svd.se 16.4.2008
Kända forskare står med sina namn bakom rapporter från läkemedelsstudier. I själva verket är författarna ofta anställda på läkemedelsföretag eller inhyrda spökskrivare. (...)

Spökskrivare bakom vetenskapliga rapporter
svd.se 15.4.2008
Ett stort antal vetenskapliga rapporter om läkemedel är skrivna av anställda på läkemedelsföretag eller betalda spökskrivare. Men deras namn hålls hemliga. Istället köps ledande akademiska forskare in som författare ibland utan att ha haft något med studierna att göra. En ledande vetenskaplig tidskrift kräver nu ett stopp för "manipulationerna". (...)

- GlaxoSmithKline beskyldes for å skjule bivirkninger

Medicinalfirma beskyldes for at skjule bivirkninger
business.dk 15.7.2010
GlaxoSmithKline forsøgte angiveligt at skjule alvorlige bivirkninger ved middel mod diabetes 2.

Igennem 11 år har det velkendte medicinalfirma GlaxoSmithKline forsøgt at skjule, at firmaets diabetesmedicin Avandia rent faktisk ikke er bedre end sin nærmeste konkurrent. Samtidig har man forsøgt at sløre, at det kunne være risikabelt for hjertet at tage medicinen, skriver New York Times ifølge Politiken.dk. (...)

(Anm: Avandia (rosiglitazone) - informasjon versus kunnskap og visdom - hvem visste hva? (mintankesmie.no).)

Anklage: Medicinalfirma skjulte ubehagelige data
politiken.dk 14.7.2010
GlaxoSmithKline forsøgte angiveligt at skjule alvorlige bivirkninger ved middel mod diabetes 2.

Medicinalfirmaet GlaxoSmithKline (GSK) har i 11 år forsøgt at skjule, at firmaets diabetesmedicin Avandia ikke var bedre end sin nærmeste konkurrent, og at det kunne være risikabelt for hjertet at tage medicinen.

Det skriver New York Times.

LÆS ARTIKEL Hele artiklen fra New York Times (eksternt link - på engelsk)

Risikoen ved Avandia, der bruges mod diabetes type 2, blev første gang offentliggjort i maj 2007, otte år efter at midlet var introduceret på markedet.

Dengang sagde GSK, at firmaet havde kendt til en mulig risiko ved midlet siden 2005. (...)

Ifølge nyhedssitet Bloomberg har GlaxoSmithKline, som er et af verdens største medicinalfirmaer, indvilget i at betale omkring 4,5 milliarder kroner for at bilægge en række søgsmål som følge af helbredsrisikoen ved Avandia. (...)

(Anm: Avandia (rosiglitazone) - informasjon versus kunnskap og visdom - hvem visste hva? (mintankesmie.no).)

Glaxo Plans $2.3 Billion Liability Charge (Glaxo avsetter 2,3 milliard dollar til erstatningsansvar)
nytimes.com 15.7.2010
Det britiske legemiddelfirmaetGlaxoSmithKline uttalte torsdag at de tar et tap i andre kvartal på 2,36 milliarder dollar relatert til rettslige saker som involverer Avandia og Seroxat (Paxil). (...) (GlaxoSmithKline, the British pharmaceutical company, said on Thursday that it would take a second-quarter charge of $2.36 billion related to legal cases involving its drugs Avandia and Paxil.)

(Anm: Avandia (rosiglitazone) - informasjon versus kunnskap og visdom - hvem visste hva? (mintankesmie.no).)

(Anm: Seroxat (Paxil) (paroxetine; paroksetin) (SSRI) (mintankesmie.no).)

Glaxo on red alert as FDA scrutinises diabetes drug Avandia (Kipper Williams)
guardian.co.uk 12.7.2010
The FDA is holding a hearing into Glaxo's controversial blockbuster diabetes drug Avandia to decide if is a potential killer (...)

Glaxo has been accused of trying to silence scientists and of endangering the lives of patients since a 2007 study by a cardiologist at Cleveland Clinic suggested Avandia could raise the incidence of heart attacks by 43%. Britain's biggest drugs company has vigorously defended its drug, producing studies suggesting Avandia is safe, but the pill's sales have halved from £1.4bn in 2006 to £771m last year.

"Since 2007 we have seen results from six controlled clinical trials looking at the cardiovascular safety of Avandia and together they show this medicine does not increase the overall risk of heart attack, stroke or death," said Murray Stewart, Glaxo's vice-president for clinical development. (...)

- Leger diktet opp resultater

FDA Staff: Sanofi Ignored Ketek Problems (FDA stab: Sanofi ignorerte Ketek-problemer)
forbes.com 12.2.2008
WASHINGTON - En statlig gransker opplyste at Sanofi-Aventis satt på bevis om at deres sikkerhetsstudie på antibiotika inneholdt forfalskede data, men innsendte dem allikevel til Food and Drug Administration. (WASHINGTON - A government investigator said Sanofi-Aventis had evidence that its safety study of its antibiotic contained fake data, but submitted it to the Food and Drug Administration anyway.)

"Katastrofal svikt" var beskrivelsen FDA-gransker Douglas Loveland ga i høringen på tirsdag om firmaets behandling av studien. (...) ("Catastrophic failure" was how FDA investigator Douglas Loveland described the company's handling of the study in a hearing on Tuesday.)

Ketek, som ble godkjent i 2004, fikk FDAs alvorligste advarsel februar sist år etter rapporter om leversvikt. FDA gikk senere tilbake og og fant at flere leger hyret av Aventis forfalsket data i 2002-studien. En lege soner en fireårig dom etter å ha erklært seg skyldig i å dikte opp resultater. (...) (Ketek, approved in 2004, received FDA's most serious warning last February after reports of liver failure appeared. FDA later went back and found that several physicians hired by Aventis falsified data in the 2002 study. One is now serving a four-year sentence after pleading guilty to making up results.)

(Anm: Ketek (telithromycin) (mintankesmie.no).

Merck betaler flere milliarder kroner i erstatning grunnet økonomiske misligheter og bestikkelser av leger

Merck betalar 649 miljoner dollar i skadestånd
lakemedelsvarlden.se 8.2.2008
Amerikanska Merck har gått med på att betala 649 miljoner dollar i skadestånd till den amerikanska staten. Uppgörelsen är slutet på ett rättsfall där företaget anklagats för att ha lurat finansieringssystemen och mutat läkare. En tidigare anställd på Merck får 68 miljoner för att han avslöjade fusket. (...)

Domstol behandler sak hvor Merck forsøkte å "nøytralisere" og "svekke tilliten til" leger som var kritiske til Vioxx

Court hears how drug giant Merck tried to "neutralise" and "discredit" doctors critical of Vioxx (Domstol behandler sak hvor Merck forsøkte å "nøytralisere" og "svekke tilliten til" leger kritiske til Vioxx)
BMJ 2009;338:b1432 (6 April)
The drug company Merck drew up a list of influential doctors and researchers it wanted to "neutralise" and "discredit," as part of its marketing of the arthritis drug Vioxx (rofecoxib), according to evidence heard by an Australian court this week.

Details of the plans to "neutralise" doctors surfaced during a class action against Merck on behalf of hundreds of Australians who had heart attacks or strokes after taking the drug, which was withdrawn in 2004 after concerns about safety. (...)

Korrupsjonsgranskning setter italiensk legemiddelkontroll under press

Corruption probe puts pressure on Italian drug regulator (Korrupsjonsgranskning setter italiensk legemiddelkontroll under press)
pharmatimes.com 23.5.2008
A drug licences-for-cash scandal has engulfed Italy's medicines regulatory agency with leading officials arrested along with people linked to major pharmaceutical companies.

The most senior figure to have been held is Pasqualino Rossi, vice-president of Aifa (the Italian Agency for Pharmaceuticals). Dr Rossi is also one of Italy's most senior representatives at the European Medicines Agency. (...)

Italy's La Repubblica newspaper named the drug giants Bayer and GlaxoSmithKline, as two companies with links to some of the arrestees. Daniele Rosa, a spokesman for Bayer's Italian division said: "The investigation does not concern the behaviour of the company, but alleged behaviour that could be traced back to some collaborators whose behaviour the company has no knowledge of. We will cooperate, as always, with the investigating authorities for everything that will be requested."

Massimo Escani, a spokesman for GSK in Italy, denied that any associates of the company were involved in the scandal. "The claims are completely untrue. We deny any involvement whatsoever. These reports are groundless," he said. (...)

Martin Jarvis, a spokesman for the London-based EMEA, said: "We are aware of the reports and we have written to the Italian authorities in order to clarify Dr Rossi's status. Our concern is that he is in a position to perform his duties at the EMEA." (...)

Deprimerende forskning

Depressing research (Deprimerende forskning)
Editorial (Leder)
Lancet 2004;363:1335
Det er vanskelig å forestille seg den lidelse foreldrene, slektninger, og venner til et barn som har tatt sitt liv har opplevd. At et slik hendelse kunne være fremskyndet av et angivelig nyttig legemiddel er en katastrofe. Forestillingen om at legemidlets bruk er basert på selektiv rapportering av fordelaktig forskning burde være utenkelig. Imidlertid tyder en metaanalyse av Craig Whittington og kollegaer i denne ukes utgave av Lancet (s 1341) på at dette er hva som har skjedd for forskning på bruk av antidepressiva hos barn. Deres resultater illustrerer misbruk av den tillit pasienter har til sine leger. De beskriver også misbruk av tilliten til frivillige forsøkspersoner innen medisinen og farmasien. (It is hard to imagine the anguish experienced by the parents, relatives, and friends of a child who has taken his or her own life. That such an event could be precipitated by a supposedly beneficial drug is a catastrophe. The idea of that drug's use being based on the selective reporting of favourable research should be unimaginable. In this week's issue of The Lancet (p 1341), however, a meta-analysis by Craig Whittington and colleagues suggests that this is what has been happening for research into the use of antidepressants in childhood. Their results illustrate an abuse of the trust patients place in their physicians. They also represent an abuse of the trust placed by trial volunteers in the medical and pharmaceutical establishments.)

Historien om forskning på bruk av selektive serotoninreopptakshemmere (SSRI-er) på depresjon hos barn er fylt med forvirring, manipulasjon, og institusjonell svikt. Selv om publiserte bevis i beste fall var selvmotsigende, er bruk av SSRI-er til behandling av depresjon hos barn blitt oppmuntret av farmasøytiske firmaer og klinikere over hele verden. Sist måned avslørte tidsskriftet til Canadian Medical Association utdrag fra et internt notat fra GlaxoSmithKline som viser hvordan firmaet forsøkte å manipulere resultatene av publisert forskning. Angående en studie på bruk av paroxetine (Seroxat) hos barn, sier notatet ”Det ville være uakseptabelt å inkludere en redegjørelse om at effektivitet ikke er vist, idet det ville undergrave profilen til paroxetine”. Sist år forbød Committee on Safety of Medicines i Storbritannia alle SSRI for behandlingen av depresjon hos barn med unntak av fluoxetine. Til tross for dette synes det som om Food and Drug Administration i USA sist uke har mislykkes i å ta de nødvendige forholdsregler på grunnlag av informasjon om at disse legemidler er både ineffektive og skadelige for barn. (The story of research into selective serotonin reuptake inhibitor (SSRI) use in childhood depression is one of confusion, manipulation, and institutional failure. Although published evidence was inconsistent at best, use of SSRIs to treat childhood depression has been encouraged by pharmaceutical companies and clinicians worldwide. Last month, the Canadian Medical Association Journal revealed excerpts from an internal GlaxoSmithKline memorandum demonstrating how the company sought to manipulate the results of published research. Concerning a study of paroxetine use in children, the memorandum states “It would be unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine”. Last year the UK Committee on Safety of Medicines prohibited the treatment of childhood depression with any SSRI except fluoxetine. Despite this, the Food and Drug Administration in the USA appears last week to have failed to act appropriately on information provided to them that these drugs were both ineffective and harmful in children.)

I en global medisinsk kultur hvor bevisbasert praksis er sett på som gullstandard for omsorg, er denne svikt en katastrofe. Metaanalyser av publiserte data støtter et økende antall kliniske beslutninger og retningslinjer, som i sin tur tilsier bruk av enorme ressurser innen helsevesenet. Denne prosess er fullstendig overflødig dersom resultater så lett kan manipuleres av de som mulig har stor økonomisk profitt. Det globale salg av for eksempel GlaxoSmithKlines SSRI paroxetine beløp seg til 4,97 milliarder dollar bare sist år. Videre er nytten til organisasjoner slik som National Institute for Clinical Excellence (NICE) betydelig undergravet i tilfeller hvor de kun har adgang til data for helseprodukter som er sett på som fordelaktig for produktets fabrikanter. (In a global medical culture where evidence-based practice is seen as the gold standard for care, these failings are a disaster. Meta-analysis of published data supports an increasing number of clinical decisions and guidelines, which in turn dictate the use of vast levels of health-care resources. This process is made entirely redundant if its results are so easily manipulated by those with potentially massive financial gains. The global sales of the GlaxoSmithKline SSRI paroxetine, for example, amounted to US$4•97 billion last year alone. Moreover, the utility of organisations such as the National Institute for Clinical Excellence (NICE) is significantly undermined in circumstances where they are only able to access data on health-care products that are seen as advantageous to the products' manufacturers.)

Hvor sikker er samfunnet på at liknende svikt ikke vil forekomme i større skala i fremtiden? UK Biobank har til hensikt å rekruttere og følge en gruppe mennesker på omkring 500 000 frivillige. De innsamlede dataene vil delvis bli brukt til å utvikle nye farmasøytiske produkter og diagnostiske tester. Mye tid og innsats er allerede blitt investert på å sikre hensiktsmessige reguleringer og etiske prinsipper er på plass for alle trinn i prosjektet. Imidlertid er linkene mellom UK Biobank og den farmasøytiske industri allerede tydelige. John Bell, leder for UK Biobank science committee er også direktør hos Roche. I tillegg er i det minste deler av det estimerte beløp på 70-500 millioner pund som kreves for å komplettere prosjektet forutsatt å komme fra industrielle finansieringskilder. Med nivået på dette engasjement, vil et farmasøytisk firma virkelig føle seg forpliktet å publisere informasjon som kommer fra disse frivillige om at dets produkter ikke virker? (How confident is society that similar failings will not occur on a larger scale in the future? UK Biobank intends to recruit and follow a cohort of around 500 000 volunteers. The data collected will be used in part to develop new pharmaceutical products and diagnostic tests. Much time and effort has already been invested into ensuring appropriate regulatory and ethical principles are in place for all stages of the project. However, the links of UK Biobank with the pharmaceutical industry are already clear. John Bell, chair of the UK Biobank science committee is also a director at Roche. In addition, at least part of the estimated £70-500 million required to complete the project is envisaged as coming from industry sources. With this level of involvement, will a pharmaceutical company really feel obliged to publish information derived from these volunteers that one of its products does not work?)

Det kreves forandringer på ethvert nivå for infrastrukturen innen den globale helseomsorg. Myndighetene trenger å samarbeide effektivt på sikkerhetsspørsmål snarere enn å duplisere anstrengelsene. Statlige institusjoner slik som NICE krever rettslige fullmakter for å sikre at biomedisinsk forskning brukes til å forbedre helse selv om det ikke settes likhetstegn mellom dette og økt profitt. På et individuelt nivå, må leger og ansatte i farmasøytiske firmaer huske at uten tilliten til frivillige og pasienter i forsøk ville medisinsk forskning og praksis være umulig. Folk rundt omkring i verden forstår ønsket om å oppnå suksess og å arbeide i et profitabelt miljø. De vil imidlertid ikke tolerere at dette kunne skje innen biomedisinsk forskning på bekostning av deres barns liv. (...) (Changes are required at every level of the global health-care infrastructure. Governments need to collaborate effectively over issues of patients' safety rather than duplicating efforts. Governmental institutions such as NICE require legal powers to ensure that biomedical research is used to improve health even if this does not equate with improved profits. On an individual level, doctors and pharmaceutical company employees must remember that without the trust of trial volunteers and patients medical research and practice will become impossible. People around the world understand the desire to achieve success and to work in a profitable environment. They will not, however, tolerate the notion that in biomedical research this could be at the expense of their children's lives.)

Depressing research (Deprimerende forskning)
Lancet. 2004;363:2087
Sir — Hemmeligholdelse av publikasjonen om negative forsøk med selektive serotoninreopptakshemmere (SSRI) på barn (24. April, s 1335)1 er mer enn bare et spørsmål om “forvirring, manipulasjon, og institusjonell svikt”. Det er kriminalitet. For uten videre å illustrere dette, kan vi analogisere situasjonen som følger: ville du være bekymret dersom en kollega forskrev pencillin til et barn som hadde en ukomplisert øvre luftveiesinfeksjon av viral etiologi? Ville du være mer bekymret dersom du hørte at dette barn fikk en alvorlig anafylaktisk reaksjon på pencillin hjemme? Og hvor mye mer bekymret ville du være dersom du fant at den forskrivende lege fra tidligere av var oppmerksom på at barnet hadde alvorlig pencillinallergi? Det sistnevnte scenario kunne bli bedømt som uaktsomhet. Imidlertid når det er akseptabelt for farmasøytiske firmaer å stanse publikasjon av SSRI-studier som viste en mangel på effektivitet og økt risiko for alvorlige uheldige hendelser hos barn og voksne i eksperimentelle gruppeforsøk (andre enn for fluoxetine)?2 Må forsettlig hemmeligholdelse av disse data, en beskyldning som der allerede er offentlige bevis for,3 anses som korporativ vold. (Sir--Suppression of the publication of negative trials of serotonin-selective reuptake inhibitors (SSRI) in children (Apr 24, p 1335)1 is more than just a matter of “confusion, manipulation, and institutional failure”. It is a crime. To blandly illustrate its severity, we can analogise the situation as follows: would you be concerned if a colleague prescribed penicillin to a child who had an uncomplicated upper respiratory tract infection of viral aetiology? Would you be more concerned if you heard that this child had a serious anaphylactic reaction to the penicillin at home? And how much more concerned would you be if you found out that the prescribing doctor was previously aware of the child's severe penicillin allergy? The latter scenario could be deemed malpractice. How, then, is it acceptable for pharmaceutical companies to suppress publication of SSRI studies that showed a lack of efficacy and an increased risk of serious adverse events in the children and adolescents in experimental trial groups (other than for fluoxetine)?2 Intentional concealment of these data, an accusation for which there is already public evidence,3 must be considered a form of corporate violence.)

Dersom vårt rettssystem ikke har hensiktsmessige mekanismer til å holde multinasjonale selskaper ansvarlig for sine skadelige handlinger, da bør vi identifisere de personer som til syvende og sist er ansvarlige for selskapets beslutninger. Ansvarlighet må også til dels kreves av forskende leger som stilltiende er medskyldig i hemmeligholdelse av kritisk informasjon eller forfatterskapet til villedende artikler. Viktigere enn eventuelle straffende eller rettslige reaksjoner er behovet for å sikre at alle kliniske forsøk blir registrert, utført, analysert, og publisert på en hensiktsmessig og objektiv måte. Publikasjonbias bør i det minste være et hinder som lett kan unngås når det gjelder formidling av de beste medisinske bevis. (If our legal systems do not have adequate mechanisms to hold multinational corporations accountable for their harmful actions, then we should identify the individuals who are ultimately responsible for corporate decisions. Accountability must also be claimed in part by the physician investigators themselves who were silently complicit in the suppression of crucial information or the authorship of misleading articles. More important than any punitive or legal reaction is the need to ensure that all clinical trials are registered, conducted, analysed, and published in an appropriate and objective manner. Publication bias should be at least one easily avoided obstacle to the dissemination of the best medical evidence.)

Leger må handle raskt og bestemt for å frigjøre seg fra legemiddelfirmaene, siden våre interesser drastisk kan være forskjellig.4 Korporativ manipulasjon av data fra pediatriske SSRI-forsøk er en redselsfull avsløring som burde sende sjokkbølger gjennom det internasjonale kliniske forskersamfunnet. Dersom bevisbasert medisin fortsatt skal være et effektivt verktøy for forbedring av omsorg og ivareta pasientsikkerhet, da må vi nå kollektivt fordømme firmaene og personene hvis handlinger underminerer integriteten til medisinsk vitenskap. (...) (Physicians must act quickly to firmly disentangle themselves from drug companies, since our interests can drastically diverge.4 Corporate manipulation of data from paediatric SSRI trials is an appalling revelation that should send shockwaves through the international clinical research community. If evidence-based medicine is to continue to be an effective tool for improving care and ensuring patients' safety, then we must now collectively condemn the companies and individuals whose actions undermine the integrity of medical science.)

(Anm: Campaign is launched to make patients the focus of evidence based medicine. BMJ 2014;349:g4443 (03 July 2014).)

Er GlaxoSmithKline (GSK) skyldig i bedrageri?

Britain to Seek More Drug Information (Storbritannia søker mer legemiddelinformasjon)
forbes.com 24.3.2008
LONDON - Britain plans to require pharmaceutical companies to share more information with regulators about clinical trials after an investigation recently concluded that GlaxoSmithKline PLC deliberately withheld information about an antidepressant. (...)

UK Seeks More Trial Data From Pharmas (Storbritannia søker mer forsøksdata fra legemiddelfiramer)
forbes.com 24.3.2008
LONDON -
Britain plans to force pharmaceutical companies to share more information with regulators about clinical trials after an investigation recently concluded that GlaxoSmithKline PLC deliberately withheld information about an antidepressant.

The four-year probe by the Medicines and Healthcare products Regulatory Agency, completed earlier this month, said the British company should have revealed more quickly that Seroxat sometimes increased the suicide risk in teenagers - by more than six times.

But without stronger legislation in place, the MHRA admitted there is no chance of prosecuting the company for what the agency perceives as an ethical lapse. (...)

Is GSK guilty of fraud? (Er GSK skyldig i bedrageri?)
Edtorial (Leder)
Lancet 2004;363:1919 (12.06.2004)
Hvorvidt paroxetine, en selektiv serotoninreopptakshemmer produsert av GlaxoSmithKline, bør forskrives til deprimerte barn og ungdom er blitt tema for en nylig klinisk tvist (se Lancet 2004;363:1335). Debatten om legemidlers effektivitet og sikkerhet har som regel vært begrenset til den akademiske medisin og legemiddelregulering. Men sist uke ble spørsmålet kastet inn på en mye større arena, i form av et søksmål mot GSK i New York fra riksadvokat, Eliot Spitzer. Staten anklager firmaet for bedrageri, ved å berøve forbrukerne informasjonen som de og deres leger trenger for å gjøre informerte beslutninger om behandling, og søker tilbakebetaling av all profitt oppnådd på uredelig vis. (Whether paroxetine, a selective serotonin reuptake inhibitor made by GlaxoSmithKline, should be prescribed to depressed children and adolescents has been the subject of recent clinical controversy (see Lancet 2004; 363: 1335). Debate over the drug's efficacy and safety has been mostly confined to the academic medical and drug-regulatory communities. But last week the issue was catapulted into a much wider arena, with the filing of a lawsuit against GSK in New York by that state’s Attorney General, Eliot Spitzer. The state accuses the company of fraud, by depriving consumers of the information they and their doctors need to make informed decisions about treatment, and seeks the return of all profits obtained through fraudulent means.)

Innsatsen er høy, for alle impliserte. GSKs nettoinntekt i 2002 var mer enn 6,9 milliarder dollar, og i første kvartal 2004, var salget av paroxetine 533 millioner dollar. 2,1 millioner forskrivninger av paroxetine for barn ble utstedt i USA i 2002. (The stakes are high, for all concerned. GSK's net income in 2002 was more than US$6,9 billion, and in the first quarter of 2004, sales of paroxetine were $533 million. 2,1 million paroxetine prescriptions for children were written in the USA in 2002.)

Historien om dette legemidlet har vært full av kroker og irrganger, godkjenninger og advarsler. Paroxetine er godkjent for behandlingen av forskjellige psykiatriske lidelser hos voksne men er ikke godkjent, verken i Europa eller Nord-Amerika, for bruk hos pasienter yngre enn 18. Men ganske ofte, kan leger forskrive legemidler på ikke godkjente indikasjoner, dersom de tror dette er til det beste for pasienten. I USA er forskrivning for ”Bruk utenfor godkjent preparatomtale” ikke bestemt av Food and Drug Administration (FDA), men av de enkelte stater som regulerer den medisinske praksis. Slik kan staten New York påberope seg vergeplikt for å beskytte pasienter. (The story of this drug has been full of twists and turns, approvals and warnings. Paroxetine is approved for the treatment of various psychiatric disorders in adults but is not approved, either in Europe or North America, for use in patients younger than 18. But not uncommonly, doctors can prescribe drugs for unapproved indications, if they believe this is in the best interest of the patient. “Off-label” prescribing in the USA is governed not by the Food and Drug Administration (FDA) but by individual states, which regulate the practice of medicine. So the state of New York can claim a fiduciary duty to protect patients.)

Paroxetines sikkerhet og effektivitet hos barn er blitt testet i minst fem studier sponset av GSK, bare én av disse er blitt publisert. Selv om forsøkets resulter var blandet, ble det i tittelen til et notat proklamert at ”Paxil viser BEMERKELSESVERDIG effektivitet og sikkerhet i behandlingen av depresjon hos ungdommer”. De andre studier viste enten blandet eller negative resultater: paroxetine var bedre enn placebo i behandlingen hos barn, og var forbundet med en mulig økt risiko for selvmordstanker og handling. Det som betegnet selvmordsatferd ble omsider kodet som ”emosjonell ustabilitet”. Leger fikk noe av denne informasjon, ikke alle, bare de som spesielt ba om det. Et internt notat fra GSK i 1998, nå fornektet, tok sikte på å ta hånd om ”spredningen av disse data for å minimalisere potensielle negativ kommersiell påvirkning”. (Paroxetine’s safety and efficacy in children have been tested in at least five studies sponsored by GSK, only one of which has been published. Although that trial’s results were mixed, they were heralded in a memorandum entitled “Paxil demonstrates REMARKABLE Efficacy and Safety in the treatment of adolescent depression”. The other studies showed either mixed or negative results: paroxetine was no better than placebo at treating depression in children, and was associated with a possibly increased risk of suicidal thinking and acts. What constituted suicidal behaviour was eventually coded as “emotional lability”. Doctors were able to obtain some, though not all, of this information, only by specific request. An internal memorandum issued at GSK in 1998, now disavowed, was aimed at managing “the dissemination of these data in order to minimize any potential negative commercial impact”.)

Søksmålet anfører at GSK hemmeligholdt resultatene fra disse studier, unnlater å gjøre dem tilgjengelige for leger, et “gjentagende og vedholdende bedrageri”. Ved kun å gi delvis informasjon om sikkerhet og virkeevne ga GSK leger et partisk og villedende bilde av legemidlet. Leger var derfor ikke i stand til å vurdere balansen mellom risiko og nytte og kunne ikke utøve sine faglige plikter overfor sine pasienter. (The lawsuit alleges that GSK suppressed the results of these studies, failing to make them available to doctors, in a demonstration of “repeated and persistent fraud”. By providing only partial information about safety and efficacy, GSK caused doctors to have a biased and misleading picture of the drug. Doctors were thus unable to assess the balance of its risks and benefits and could not discharge their professional duties to their patients.)

GSK fastholder at de har “handlet ansvarlig” når det gjelder studier og formidling av resultater. Åpen redegjørelse av resultatene har imidlertid vært begrenset til GSK, FDA og andre statlige legemiddelkontroller. Firmaet hevder å “ha offentlig kommunisert data fra alle pediatriske studier”, tilsynelatende i abstrakts form på konferanser hvor nesten utelukkende spesialister var tilstede. (GSK maintains that it has “acted responsibly” in undertaking studies and in disseminating their results. Disclosure of the results, however, by GSK’s own admission, has been limited to the FDA and other regulatory agencies. The company claims to “have publicly communicated data from all pediatric studies”, apparently in abstract form at conferences attended almost exclusively by specialists.)

GSK synes å rote på de semantiske dyp. Mens de har vært alvorlig spaltet i betydningen av ”selvmordstanker og handlinger” og “offentlighet”, synes de å ha glemt hva som ligger bak disse ord - mennesker. Mennesker innrullert i GSKs studier; mennesker kjøpte legemidlet; mennesker ga samtykke til å delta i forsøk, trodde antakelig at resultatene ville bli offentliggjort. Mange forskere og tidsskrifter har sterkt argumentert for at alle kliniske forsøk burde registreres og publiseres. Men som søksmålet utilslørt anskueliggjør, er tiden inne for at disse forhold blir avslørt i et sterkt – og offentlig lys. Ved å flytte spørsmålet til den offentlige sfære, kan den farmasøytiske industri bli tvunget til å erkjenne at alle resultater, enten de er positive eller negative, kan bli tilgjengelige i kraft av den frivillige medvirkning fra publikum. (GSK appears to be floundering in the semantic depths. While it has been earnestly parsing the meaning of “uicidal thinking and acts”and “publicly”, it appears to have forgotten what lies behind those words--people. People enrolled in GSK's studies; people bought the drug; people gave consent to participate in trials, presumably believing the results would be made public. Many researchers and journals have argued strongly that all clinical trials should be registered and all their results published. But as the lawsuit pointedly demonstrates, the time has come for these matters to be revealed in a bright and public light. By moving the issue into the public sphere, the pharmaceutical industry may be forced to acknowledge that all its results, whether positive or negative, are obtained only by virtue of the voluntary cooperation of the public.)

Denne strid burde følge eksempelet fra en nylig rettstvist mot tobakksfirma. GSK må opprette et offentlig arkiv for alle dokumenter relatert til paroxetine under 18 år. Dersom GSK ikke har noe å skjule, som de hevder, burde de åpne sine filer før de blir beordret å gjøre det av retten – og gjøre det med en gang. (This contest ought to follow the example set by recent tobacco-company litigation. GSK must create a public archive of all documents relating to paroxetine in under-18s. If GSK has nothing to hide, as it claims, it should open its files before being ordered to do so by a court--and do so right now.)

(Anm: semantikk: (av gr. 'gi tegn, bety, betegne').) 1) (filos.) Læren om betydninger, deres natur og funksjon; (...) Til semantikk hører ulike teorier om hva sannhet er, f.eks. den oppfatning at et uttrykk er sant hvis det refererer til og stemmer med noe som eksisterer. (...). Kilde: Store norske leksikon.)

Granskning av GlaxoSmithKline - Seroxat (paroxetine)

1463 days to nothing - the GlaxoSmithKline Criminal Investigation
scientific-misconduct.blogspot.com 7.10.2007
It is four years ago this week that the UK drug "watchdog" the MHRA started an "independent" "criminal" "investigation" of GlaxoSmithKline over paroxetine clinical trials. This followed the clear appearance that Britain’s biggest pharmaceutical group had withheld data and had misrepresented clinical trials findings to both patients and prescribers. (...)

Scientific Publications Strategy: Managing Reputation, Clinical Trial Results and Commercial Relevance

Scientific Publications Strategy: Managing Reputation, Clinical Trial Results and Commercial Relevance
3.best-in-class.com (17.2.2008) (Best Practices, LLC)
STUDY OVERVIEW
Study Background - Over the past few years, scientific journals and government regulators have increased the scrutiny and expectations facing pharmaceutical companies looking to publish the results of their clinical trials. While picking and choosing favorable findings may have been acceptable a decade ago it is now considered unethical and potentially illegal. As a result of these changing expectations and regulations, global publications leaders at pharmaceutical companies are carefully building strategy that ethically presents all study findings while still driving brand strength.

Study Objective - This research was launched to determine how leading pharmaceutical and biotechnology companies are shaping their global publications strategies and plans in order to maintain scientific credibility while also delivering commercially relevant publications that drive brand success. Benchmark participants from 14 leading pharmaceutical companies provided their insights and metrics to identify industry trends and performance standards. (...)

Glaxo "bagatelliserte" advarsel om risiko for hjerteanfall fra legemiddel mot AIDS

Glaxo 'downplayed' warning on heart-attack risk from Aids drug (Glaxo "bagatelliserte" advarsel om risiko for hjerteanfall fra legemiddel mot AIDS)
independent.co.uk 12.5.2008
GSK was told of a possible link between abacavir and heart attacks in 2005

The multinational drugs company GlaxoSmithKline (GSK) downplayed an early warning about the rising number of people who have suffered heart attacks after using one of its drugs, abacavir. An anti-Aids medication, abacavir is taken by tens of thousands of people worldwide.

GSK was officially told of the possible risk in May 2005, three years before it issued a statement to its investors saying that the findings of an even stronger potential link between heart attacks and abacavir are "unexpected" and "unconfirmed". The company also said that it could find no association between abacavir use and heart attacks following a trawl through its internal data.

owever, it failed to mention that its own summary of product characteristics issued when the drug was launched in the late 1990s had described "mild myocardial degeneration" in mice and rats given the drug for two years. (...)

Mange vil være forsøkskaniner

Prøvekaniner for vestlig medisin
ukeavisenledelse.no 19.3.2009
Medisinske forsøk flyttes i hurtig tempo til fattige land, viser ny rapport. Grov skjevfordeling, mener norsk professor.

Fattige mennesker i u-land er stadig oftere provekaniner for vestlig medisin. Testingen foregår oftest i Øst-Europa, Afrika og Afrika.

Mange av medisinene som testes ut er ikke en gang vanlige i disse landene. Det er her snakk om typiske i-landsykdommer som hjerte- og karsykdommer, muskelsmerter og blærekatarr.

Rapporten fra Duke Clinical Research Institute har vært publisert i The New England Journal of Medicine.

Antallet land utenfor USA som blir brukt i medisinske forsøk er mer enn doblet fra 1995 til 2005, viser rapporten. Det skal være billigere å utføre forsøkene i u-land, som i tillegg har stor tilgang på forsøkspersoner.

– Slik forskning er grovt problematisk, sier professor i medisinsk etikk Jan Helge Solbakk, til Dagsavisen.

Mennesker i u-land blir dobbelt utnyttet fordi de brukes i forsøk som tjener den rike delen av verden, samtidig som det forskes lite på sykdommer som rammer dem, mener Solbekk.

90 prosent av ressursene til medisinsk forskning i verden brukes til sykdommer som rammer de 10 prosent rikeste.

– En grov skjevfordeling av midlene, som stater stilltiende aksepterer. Stater bør stilles til ansvar for brudd på menneskerettigheter, sier Solbekk til avisen. (...)

Tester medisiner på fattige i Sør
helserevyen.no 11.6.2007
Det er nå først og fremst de fattige i Sør som stiller kroppene sine til disposisjon for den multinasjonale legemiddelindustrien. Dermed får industrien raskt og billig testa ut medisiner mynta på markedene i USA og Vest-Europa.

Hvert år bruker den multinasjonale legemiddelindustrien nesten 240 milliarder kroner på å utvikle nye medisiner. Innbyggerne i USA vil i liten grad være ”prøvekaniner”, og industrien vender nesa sørover for å utføre de stadig mer kostbare og risikable forsøkene, skriver den kanadiske journalisten Sonia Shah i en artikkel i juniutgaven av norske Le Monde Diplomatique. I artikkelen tar hun utgangspunkt i sin egen bok ”The Body Hunters. Testing New Drugs on the World’s Poorest Patients”. (...)

Villige til å prøve nye medisiner
ukeavisenledelse.no 18.5.2006
Seks av ti nordmenn vil sannsynligvis delta i utprøving av nye medisiner dersom de ble syke viser en undersøkelse Opinion har gjort.

”Hvis du fikk en sykdom og en ny medisin var under utvikling. Hvor sannsynlig er det at du ville si ja til å delta i en utprøving av medisin?” lød spørsmålet og 22 prosent av de spurte svarte ”svært sannsynlig” og 44 prosent ”ganske sannsynlig”.

- For å utvikle nye og bedre medisiner er legemiddelindustrien avhengig av både friske frivillige og pasienter i de ulike kliniske utprøvingsfasene. Derfor er disse tallene en oppmuntring både for bransjen og for alle som er opptatt av bedre legemiddelutvikling, sier Pål Christian Roland, administrerende direktør i Legemiddelindustriforeningen (LML). (...)

- Når medisinen er klar for å bli testet på mennesker, er målet å få kunnskap om ønskede og uønskede effekter. Mange pasienter som deltar i en studie, opplever fordeler som bedre medisinsk oppfølging og bedre medisinering, sier Roland til HjelptilLivet, et annonsebilag for Legemiddelindustriforeningen.

Mange vil være forsøkskaniner
helserevyen.no 4.7.2005
Det er stort sett ikke noen problemer å få tak folk som kan tenke seg å være medisinske forsøkspersoner. Vanligvis melder de fleste seg frivillig.

Da Nasjonalt forskningssenter innen alternativ medisin (NAFKAM) søkte etter kvinner mellom 55 og 74 år som ville være med på klinisk utprøving av produktet ”Natto” våren 2004, glødet telefonen i dagevis. NAFKAM ville finne ut om Natto hjelper mot beinskjørhet. Dette skriver forskning.no.

Nedringt av villige forsøkspersoner
Forskningsposten ved Universitetssykehuset Nord-Norge (UNN) er helt avhengig av at folk vil være forsøkspersoner. Heldigvis stiller mange opp; i vinter ble de ansatte nedringt av folk som ville delta i et kolesterolprosjekt.

I løpet av de knapt 13 årene har avdelinga hatt over 15 000 besøk av forsøkspersoner. Det inkluderer alt fra folk som bare skal avgi en blodprøve og svare på et spørreskjema, til de som skal prøve ut medikamenter over flere år.

Må bruke mennesker
- De er det viktigste av alt. Det nytter ikke å prøve ut nye medikamenter som skal brukes på mennesker bare på rotter eller griser. Den menneskelige kroppen er for sammensatt. Derfor er forsøkspersonene alfa omega for forskningen som foregår her, forteller avdelingssykepleier Elin Hanssen ved Forskningsposten.

Lettest er det å rekruttere studenter og aldersgruppen 60+, noe som kan komme av at disse gruppene har større mulighet til å stille opp i vanlig arbeidstid. En annen stor gruppe forsøkspersoner er pasienter. De blir spurt når forskningen dreier seg om pasientenes egen sykdom.

Skal ikke være «kjøpt»
I USA har man vært opptatt av problemet med profesjonelle forsøkspersoner. Det vil si folk som gjør et levebrød av betalingen de får for å stille opp i forskningens tjeneste.

- Når det gjelder betaling er det veldig strengt i Norge. Forsøkspersonene skal ikke være ”kjøpt”, sier Elin Hanssen.

Danmark

Mange danskere i medicinforsøg
berlingske.dk 8.4.2006
20.000 gange i gennemsnit årligt deltager danskere i medicinske forsøg med nye lægemidler. Det viser en opgørelse, som Ritzau og DICAR har foretaget.

De er villige, klar til at tage risici og ikke bange af sig. I gennemsnit 20.000 gange årligt lægger danskere sig frivilligt på forsøgsbænken for lægevidenskaben og udvikling af ny medicin og helbredelsesmetoder. Det viser en undersøgelse, som Ritzau har foretaget i samarbejde med Center for analytisk journalistik (DICAR).

Det høje tal skyldes både, at Danmark er populær som forsøgssted, og at lægemiddelindustrien herhjemme bliver større og større. Det kræver benhård kontrol, lyder det fra læger, forsøgscentre og videnskabsetiske komitéer.
- Mange danskere deltager som raske i de såkaldte fase-1 forsøg, men lige så mange melder sig som forsøgskaniner, fordi de har en sygdom, som de håber, at den ny medicin eller behandling kan minimere, siger Kamma Bertelsen, overlæge ved Onkologisk afdeling på Odense Universitetshospital og nuværende formand for Bivirkningsrådet.

Sverige

Medicintest stoppas efter psykos
svd.se 24.4.2006
Publicerat 24 april 2006 17:16En 25-årig man drabbades av en psykos i torsdags efter att ha deltagit i läkemedelstester för Astra Zeneca.

Mannens tillstånd blev så allvarligt att han fick läggas in på psykiatrisk klinik och nu stoppas fortsatta studier av läkemedlet.

Försökspersonen ingick i en studie i Lund på Astra Zenecas fas 1-enhet, där läkemedel testas på människor för första gången. Åtta personer testade substansen, som ska motverka neuropatisk smärta, men endast 25-åringen drabbades av de allvarliga biverkningarna.

- Mannen var inlagd och det var när man lätt ökade dosen som han fick en akut reaktion av panikkaraktär. Den blev så svår att han fick flyttas över till psykiatrisk klinik och studien som han ingick i avbröts, säger Astra Zenecas Hans Basun, medicinskt ansvarig för läkemedlet, till TT.

Läkemedlet har tidigare testats med en fyra gånger högre dos än den som 25-åringen fick. Några försökspersoner upplevde då oro vilket ledde till att dosen sänktes.

- Dosen var inte extremt hög och enligt rapporter från enheten i Lund mår mannen bra nu. Men vi måste nu sätta oss ner och göra en ordentlig utredning av vad som har inträffat. Vi ska bland annat analysera blodprover från individen, säger Hans Basun.

På fredagen skickade Astra Zeneca ut ett formellt så kallat stoppbrev där företaget meddelade att inga tester av läkemedlet på människor kommer att genomföras innan Läkemedelsverket har fått ta del av alla dokument som tas fram.

I Sverige ingår omkring 40 000 människor i läkemedelstester varje år. Av dessa deltar omkring 5 000 i den första fasen. För en dryg månad sedan kämpade sex personer för sina liv i Storbritannien efter att ha deltagit i läkemedelstester i fas 1. Sverige omfattas av samma regler för läkemedelstester på människor som Storbritannien och övriga EU-länder, men allvarliga biverkningar i samband med läkemedelstester är ovanliga. (...)

USA

Congress Presses FDA on Investigations
online.wsj.com
WASHINGTON -- The criminal-investigations wing of the Food and Drug Administration is in hot water with Democrats and Republicans in both the Senate and the House.

The Office of Criminal Investigations, or OCI, has operated largely autonomously in recent years, emphasizing a crackdown on illegal abuse of drugs such as Oxycontin. Its budget doubled to $42.8 million from fiscal 2000 to fiscal 2009, even as FDA officials were conceding that funds for assuring the quality of imported drugs weren't adequate. Monday, the Bush administration announced it would ask Congress for an extra $275 million to beef up FDA inspections. (...)

Sen. Grassley's request follows questions raised by Democrats on the House Energy and Commerce Committee in February during a hearing on Ketek, the antibiotic made by Sanofi-Aventis SA. OCI agents testified about their unsuccessful efforts to initiate a task force on Ketek that would have looked at whether Sanofi's executives knew that an outside contractor had used fraudulent data in a clinical trial of the drug. Rep. Bart Stupak (D., Mich.), who leads the Ketek investigation in the House, wrote in a release that "OCI management did not follow through on the line agents' work, and recommendations to expand fraud investigations were ignored." (...)

Why the Data Diverge on the Dangers of Vioxx
nytimes.com 22.5.2006
Ever since Merck pulled its arthritis painkiller Vioxx off the market in September 2004 on evidence that it could cause strokes or heart attacks, the company and its lawyers have stood by the premise that it was dangerous only to patients who took it for at least 18 months.

So it was news last week when prominent medical experts said that new data from Merck indicated that Vioxx's risks started to emerge after only four months of use. The controversy is the latest illustration of how widely open to interpretation and potential corporate pressure the results of clinical trials can be — even when reported in a leading medical journal.

Critics say it is now clear that the previous data analysis was done in a way that minimized the risks of the drug. Some also say that Merck and its academic collaborators should have known about that four-month threshold and made the earlier risks clearer in a medical journal article in March 2005. (...)

Pfizer forliker sak Nigeria

Nigerians settle over Pfizer suit (In brief)
BMJ 2009;338:b2147 (27 May)
Nigerian officials have tentatively agreed to settle a lawsuit against Pfizer for $75m (£47m; 54m). The suit charged the company with testing an experimental antibiotic, trovafloxacin, on 200 children without proper consent during an outbreak of meningitis in Kano in 1996 (BMJ 2009;338:b458, doi:10.1136/bmj.b458). Eleven children died. Nigerian officials say that effective and proved treatments were readily available at the time. (...)

Pfizer employees in court over 1996 drug trial
afp.google.com 4.2.2008
KANO, Nigeria (AFP) — Three employees of US drug giant Pfizer appeared in court Monday facing criminal charges filed by the Kano state government over an allegedly illegal 1996 meningitis drug trial. (...)

The drug test allegedly led to 11 deaths and deformities in 189 other cases such as blindness, deafness, brain damage and paralysis. (...)

Endrer søksmålet mot Pfizer
dn.no 20.7.2007
(...) Den nigerianske regjeringen trakk et søksmål mot det amerikanske legemiddelfirmaet Pfizer fredag, men varsler samtidig et endret søksmål. (...)

Vi reddet 200 liv
na24.no 11.6.2007
Pfizer mener beskyldningene om vaksinedød er usanne. (...)

- Angklagene er simpelthen ikke sanne. De var usanne da de først ble reist, og er fortsatt usanne i dag, sier Hans Petter Strifeldt i Pfizer til NA24.
Han opplyser at barna som fikk Trovan-vaksinen var kjempesyke, og at Pfizer bidro til å redde liv. (...)

Pfizer Faces Criminal Charges in Nigeria (Pfizer tiltales i Nigeria)
washingtonpost.com 30.5.2007
Officials in Nigeria have brought criminal charges against pharmaceutical giant Pfizer for the company's alleged role in the deaths of children who received an unapproved drug during a meningitis epidemic.

Authorities in Kano, the country's largest state, filed eight charges this month related to the 1996 clinical trial, including counts of criminal conspiracy and voluntarily causing grievous harm. They also filed a civil lawsuit seeking more than $2 billion in damages and restitution from Pfizer, the world's largest drug company. (...)

Gömd rapport
hävdar att Pfizers försök
i Nigeria var olagligt

Läkemedelsvärlden 2006(5) (mai)
Läkemedelsföretaget Pfizer bröt mot internationell rätt när man 1996 testade det antibiotiska läkemedlet Trovan på barn som drabbats av hjärnhinneinflammation. Det konstateras i en aldrig offentliggjord nigeriansk rapport. (...)

(Anm: Secret report surfaces showing that Pfizer was at fault in Nigerian drug tests. BMJ 2006;332:1233 (27 May).)

- Eksperimenterte med barn uten lov
dagbladet.no 8.5.2006
SAKSØKES: De 30 berørte familiene saksøker nå Pfizer.
Fem døde
Den omfattende rapporten har blitt hemmeligholdt, og det er kun fordi en anonym kilde ga rapporten til Washington Post at saken nå har blitt kjent.
Fem barn døde etter å ha vært behandlet med antibiotikaen, mens seks andre barn viste tegn til leddgikt. Rapporten legger vekt på at det ikke finnes beviser for at medisinene spilte en rolle i sykdommen og dødsfallene.
Det nigerianske fagpanelet sier i rapporten at medisingiganten brøt med den nigerianske lovgivningen, med internasjonale etiske regler for medisinforsøk og med FNs barnekonvensjon. Barnas familier har bestemt seg for å saksøke medisingiganten. (...)

Legemiddelfirma testet medikament på barn uten tillatelse
vg.no 8.5.2006
Foreldrene visste ingenting da Pfizer, et av verdens største legemiddelfirma, skal ha testet et legemiddel på nigerianske barn, skriver Washington Post.

BRØT INTERNASJONAL LOV: Legemiddelfirmaet Pfizer skal ha brutt internasjonal og nigeriansk lov da det i 1996 testet et legemiddel på barn uten tillatelse fra barnas foresatte eller staten.

Reddet liv
Da Pfizer skal ha blitt konfrontert med denne saken, var selskapet svært ordknapt i forbindelse med direkte spørsmål angående anklagene mot firmaet.

Derimot holdt selskapet fast ved at det gjennomførte eksperimentet med full tillatelse fra den nigerianske regjeringen, og i henhold til nigeriansk lov.

Samtidig hevdet Pfizer at selskapet tror medikamentet reddet liv.

(Anm: Pfizer broke law with 1996 Nigeria drug test: paper. washingtonpost.com (6.5.2006).)

Forsøk kreves registrert

Trial Registration Required
Arch Surg. 2006;141:122 (February 2006)
In concert with the International Committee of Medical Journal Editors (ICMJE), Archives of Surgery will require, as a condition of consideration for publication, registration of all trials in a public trials registry (such as http://ClinicalTrials.gov). Trials must be registered at or before the onset of patient enrollment. This policy applies to any clinical trial starting enrollment after July 1, 2005. For trials that began enrollment before this date, registration will be required by September 13, 2005, before considering the trial for publication. The trial registration number should be supplied at the time of submission. For details about this new policy, and for information on how the ICMJE defines a clinical trial, see the editorials by DeAngelis et al in the September 8, 2004 (2004;292:1363-1364) and June 15, 2005 (2005;293:2927-2929) issues of JAMA. Also see the Instructions to Authors on our Web site: www.archsurg.com.

Privateide legemiddelnettverk for legemiddelstudier

Utvider suksess med privateid allmennpraksis
helserevyen.no 16.11.2005
En blanding av oppdragsforskning, bedriftshelsetjeneste og allmennpraksis skal sikre suksessen til privateide Hedmark Medisinske Senter i Hamar. (...)

Hedmark Medisinske Senter AS ble ifølge bladet Østlendingen stiftet etter at legene bak Elverum Legesenter overtok konkursboet etter Senter for kliniske studier på Hamar i oktober i fjor. Staben skal økes fra dagens seks ansatte til nærmere 30 i løpet av en treårsperiode. (...)

Palladone

Side Effects Lead FDA to Bar Sale of Painkiller (Sideeffekter fører til at FDA forbyr salg av smertestillende middel.)
New York Times 14.7.2005
Food and Drug Administration trakk et omstridt smertestillende middel fra markedet i går på grunnlag av bevis for at det kunne forårsake alvorlige sideeffekter, men en rådgivende gruppe for byrået sa at tre mye brukte astmalegemidler bør bli værende på markedet til tross for sikkerhetsbekymringer. (The Food and Drug Administration pulled a controversial painkiller from the market yesterday based on evidence it could cause serious side effects, but an advisory panel to the agency said three widely used asthma medications should remain in use despite safety concerns.)

Byråets gjennomgåelse av fire produkter som allerede er på markedet synes å være en del av en mer energisk holdning til håndhevelse etter siste års avsløringer om at smertestillende midler kjent som cox-2-hemmere er linket til hjerteproblemer. (The agency's review of four products already on the market appeared to be part of a more vigorous enforcement posture after last year's disclosures that the painkillers known as cox-2 inhibitors were linked to heart problems.)

Legemidlet Palladone, som ble trukket fra markedet i går, var et nytt kraftig smertestillende middel, markedsført av Purdue Pharma. FDA ba firmaet om å stanse salget på grunnlag av resultatene fra en firmastudie som avslørte at det kunne forårsake alvorlige sideeffekter, til og med dødsfall, når det ble kombinert med alkoholholdige drikkevarer. (The drug pulled from the market yesterday was the potent new painkiller Palladone, marketed by Purdue Pharma. The F.D.A. asked the company to stop selling it based on the results of a company study that revealed it could cause serious side effects, even death, when mixed with alcoholic beverages.)

Byrået rådet pasienter som tar Palladone å konsultere sine leger om hvorvidt de skulle fortsette å innta eventuelle ubrukte kapsler eller å skylle de ned i toalettet. (The agency advised patients taking Palladone to consult with their doctors about whether to continue taking their current supply of the medication or to flush any unused capsules down the toilet.)

Separat fra dette, konkluderte en rådgivende gruppe at tre legemidler mot astma -- Serevent og Advair fra GlaxoSmithKline og Foradil fra Novartis – var sikre nok til å bli værende på markedet til tross for bekymringer om at de kunne være linket til sjeldne livstruende astmaanfall. (...) (Separately, an F.D.A. advisory panel concluded that three inhaled drugs for asthma -- Serevent and Advair by GlaxoSmithKline and Foradil by Novartis -- were safe enough to remain on the market despite concerns that they might be linked to rare cases of life-threatening asthma attacks.)

Diabetes

Investigational Diabetes Drug Linked to Increased Risk of Death, Strokes and Heart Attacks (Diabeteslegemiddel under utprøvning linket til økt dødsrisiko, slag og hjerteanfall)
medpagetoday.com 20.10.2005
Forklar pasienter at Pargluva ikke ennå er godkjent for behandling av diabetes. (Explain to patients that Pargluva is not yet approved for treatment of diabetes.)

Minn pasienter på at der er godkjente legemidler for behandling av diabetes så vel som legemidler for behandling av hyperlipidemi. (...) (Remind patients that there are approved drugs for treatment of diabetes as well as drugs for treatment of hyperlipidemia.)

(Anm: hyperlipidemi; for høgt innhald av lipid i blodet; gjeld høgt innhald av ulike feittstoff; jf hyperlipemi; hyperlipoproteinemi. EN hyperlipidemia. Kilde: Norsk medisinsk ordbok.)

New Diabetes Drug Poses Danger to Patients, Cardiologists Say (Nytt diabeteslegemiddel utsetter pasienter for fare, sa hjertespesialister)
medicinenet.com 20.10.2005
-- Et diabeteslegemiddel som er i ferd med å bli godkjent hos Food and Drug Administration dobler risikoen for dødsfall, hjerteanfall og slag, og det bør ikke godkjennes før sikkerheten er ytterligere gransket, rapporterer et team av fremstående hjertespesialister. (- A diabetes drug about to be approved by the U.S. Food and Drug Administration doubles the risk of death, heart attack and stroke, and it should not be approved until its safety is further explored, a team of prominent cardiologists reports.)

"Jeg ønsket at vår handling er en sperre mot en rask godkjenning, som jeg trodde ville være en fare for pasienter. Jeg forsøker å unngå et nytt Vioxx," sa studieforfatter dr. Steven Nissen, medisinsk direktør ved Cleveland Clinic Cardiovascular Coordinating Center. "I manuskriptet har jeg klart oppfordret til at det gjøres et stort forsøk før godkjenning, og jeg tror at FDA vil se at det er klokt å gjøre det." ("I wanted our actions to put a roadblock in a rapid approval that I thought would present a danger to patients. I'm trying to avoid another Vioxx," said study author Dr. Steven Nissen, medical director of the Cleveland Clinic Cardiovascular Coordinating Center. "In the manuscript, I have clearly requested that a large outcomes trial be done before approval, and I believe that the FDA will see that that's a wise thing to do.")

Ironisk nok, var det Nissen og studieforfatter dr. Eric Topol, som først reiste spørsmål om sikkerheten for Vioxx i 2001. "Ingen lyttet den gang fordi det allerede var annonsert på markedet," sa Nissen. "Jeg så dette som en mulighet å stoppe et mulig risikabelt legemiddel før det ble sluppet på markedet." (Ironically, Nissen and study co-author Dr. Eric Topol were the ones who first raised safety issues about Vioxx back in 2001. "Nobody listened then because it was already on the market being advertised," Nissen said. "I saw this as a potential to stop a potentially risky drug before it got out of the gate.")

Hans studie og tilhørende lederartikkel ble publisert torsdag i Journal of the American Medical Association på grunn av de allmenne helseimplikasjoner. (His study and an accompanying editorial were released Thursday by the Journal of the American Medical Association because of the public health implications.)

- Harper's Magazine: "Ute av kontroll"

Out of Control
AIDS and the corruption of medical science

harpers.org 7.4.2006 (Harper's Magazine)
(...) The objective of the trial, PACTG 1022, was to compare the “treatment-limiting toxicities” of two anti-HIV drug regimens. The core drugs being compared were nelfinavir (trade name Viracept) and nevirapine (trade name Viramune). To that regimen, in each arm, two more drugs were added—zidovudine (AZT) and lamivudine (Epivir) in a branded combination called Combivir. PACTG 1022 was a “safety” trial as well as an efficacy trial, which means that pregnant women were being used as research subjects to investigate “safety” and yet the trial was probing the outer limits of bearable toxicity. Given the reigning beliefs about HIV’s pathogenicity, such trials are fairly commonplace, especially in the post-1994 era, when AZT was hailed for cutting transmission rates from mother to child. (...)

GRANSKNING
Desinformation om läkemedel är användbara fakta menar nätverk
Läkemedelsvärlden 2006(5) (Mai)
”En stor korruptionsskandal i läkemedelsbranschen” hävdas det i en artikel i amerikanska Harper´s Magazine. Namnkunniga forskare bemöter anklagelserna och slår sönder argumenten. Men den organisation som ska verka för god forskningsetik, Alliance for human research protection, vidhåller att artikeln är viktig och fortsätter att använda den i sitt eget informationsmaterial. (...)

Utgångspunkten är ett autentiskt fall, en ung gravid kvinna som deltog i en klinisk prövning med det antiretrovirala läkemedlet nevirapin mot hiv, och som efter en tids behandling blev sämre och så småningom avled. Sedan följer en redogörelse för hur korruption och slarvigt genomförda kliniska studier i bland annat Afrika lett till många patienters död. Den unga kvinnan rekryterades till studien trots att hon inte visade några tecken på att vara smittad med hiv, enligt artikelförfattaren. Artikeln, som är på 15 sidor, publicerades i den välrenommerade månadstidskriften Harper's Magazine i USA i mars. (...)

- Seks friske forsøkspersoner syke i en klinisk legemiddelstudie

Anger over new drug trial adverts
bbc.co.uk 5.9.2006
Mr Oakley is still receiving medical treatment

A man who fell ill during drug trials in north-west London has criticised new adverts calling for volunteers, by the firm that ran the tests.

David Oakley said Parexel should not be advertising so soon after the March trial which left six men seriously ill.

Mr Oakley told BBC News: "They haven't offered anything in regards to us, any compensation and yet they are prepared to put more people through the mill."

No comment has been made by Parexel, despite efforts to contact them. (...)

Elefantmanden har fået kræft
bt.dk 6.8.2006
En af de seks engelske mænd, som var døden nær efter et medicinforsøg, har fået kræft i lymfekirtlerne.

David Oakley har indtil nu blot været kendt som patient A. Eller i medierne som elefantmanden. Han har holdt sin skæbne skjult for næsten alle. Men nu vil han ikke tie længere. I et stort interview med den engelske avis, The Daily Mail, fortæller han om sin krops kamp for at komme sig og sin kommende krig mod kræft.

David Oakley blev til elefantmanden i marts i år, da han skulle bruge penge til sit bryllup med sin forlovede Katrina. Derfor meldte han sig til et forsøg med en ny medicin TGN1412. Det var meningen, at han skulle teste medicinen - som skulle hjælpe på gigtsmerter, læukemi og sclerose.

Men intet gik som planen. Kort tid efter, at David havde fået sin dosis af medicinen, begyndte mareridtet. Han fik høj feber, lammende smerter, hans hoved svulmede op til over dobbelt størrelse og hans indre organer satte ud. De næste otte dage svævende han mellem liv og død. (...)

- Fatalt fase 1-forsøg kan føre til strammere lovgivning

Fatalt fase 1-forsøg kan føre til strammere lovgivning
dagenspharma.dk 19.1.2016
EU skærpede sidst reglerne for fase 1-forsøg efter TeGenero-katastrofen i London i 2006. Spørgsmålet er, om den aktuelle sag fra Frankrig vil føre til yderligere stramninger

Et fase 1-forsøg i London med proteinmolekylet CD28 udviklede sig i 2006 katastrofalt. Seks raske unge mandlige forsøgspersoner fik livstruende reaktioner og varigt mén efter forsøgsbehandling med CD28 i sagen, der siden er blevet kendt som TeGenero-sagen, navngivet efter det nu lukkede firma, som stod lægemiddelkandidaten. TeGenero-sagen førte i 2007 til en skærpelse af det […]

Forsøg med neurologisk lægemiddelkandidat endte fatalt
dagenspharma.dk 18.1.2016
Et ‘first-in-man’ forsøg med et stof kaldet BIA 10-2474 har i skrivende stund kostet én rask forsøgsperson livet, og givet mindst fem andre alvorlige bivirkninger.

BIA 10-2474 er udviklet af den portugisiske farmaceutiske virksomhed Bial, og blev indtil i sidste uge i sidste afprøvet på en fase 1 enhed hos firmaet Biotrial i Rennes i Frankrig. Konkrete informationer om BIA 10-2474, selve forsøget og årsagen til, at det gik galt, er på nuværende tidspunkt sporadiske og usammenhængende. Det skyldes bl.a., […]

(Anm: Läkemedelsverket: ”Det här är extremt ovanligt”. Läkemedelsprövningen i Frankrike som misslyckades och en person avled är en tragedi. Dock är det en väldigt liten del av prövningarna, där man får den här typen av allvarliga biverkningar, säger expert på Läkemedelsverket. (lakemedelsvarlden.se 19.1.2016).)

- Ofre i legemiddelstudie får "livsvarig sykdomsutvikling"

Drug trial victims face 'lifetime of disease' (Ofre i legemiddelstudie får "livsvarig sykdomsutvikling")
netdoctor.co.uk 31.7.2006
Ofre for det katastrofale legemiddelforsøket ved Northwick Park Hospital, som etterlot seks menn kjempende for sine liv på intensivavdelingen er blitt informert om at de i fremtiden sannsynligvisvil utvikle ulike former for kreft eller andre alvorlige sykdommer. (Victims of the disastrous drugs trials at Northwick Park Hospital which left six men fighting for their lives in intensive care have been told that they are likely to develop forms of cancer or other serious illnesses in the future) .

Tre av de frivillige, som opplevde alvorlige bivirkninger av legemidlene, ble informert av leger at de permanente skader på deres immunforsvar gjør dem "svært sannsynlig" for å utvikle sykdommer. (Three of the volunteers who experienced serious adverse reactions to the drugs were informed by doctors that the permanent damage to their immune systems makes them "highly likely" to develop incurable diseases.)

Ifølge rapporter har ett offer for forsøkene allerede begynt å vise tidlige tegn på lymfatisk kreft. (According to reports, one victim of the trials has already started displaying the early signs of lymphatic cancer.)

Ifølge en rapport av professor Richard Powell, ekspert i immunologi, skaffet til veie av Sunday Times, står "ofrene overfor livsvarig kreftutvikling og alle ulike typer av autoimmune sykdommer fra lupus til MS, fra reumatoid artritt til ME (kronisk utmttelsessyndrom)". (According to a report by immunology expert Professor Richard Powell, obtained by the Sunday Times, the victims "face a lifetime of contracting cancers and all the various auto-immune diseases from lupus to MS, from rheumatoid arthritis to ME".)

Enkelte av de frivillige er for tiden i ferd med å saksøke de som utførte forsøkene via juridiske eksperter, som antyder at hver enkelt kan bli tildelt 5 millioner pund i erstatning. (Some of the volunteers are currently in the process of suing the trial operators, with legal experts suggesting that each could be awarded £5 million in damages.)

De var i utgangspunktet enige om å stille som menneskelige forsøksdeltakere ved utprøving av et legemiddel som undertrykker immunsystemet for et beløp på 2000 pund per person. (They initially agreed to become human subjects in trials of an immune system-suppressing drug for £2,000 per person.) (...)

(Anm: Autoimmune sykdommer. (nhi.no 23.8.2013).)

(Anm: Immuno-psychiatry: when your body makes its own angel dust - anti-NMDA receptor encephalitis. A new study in Biological Psychiatry reports structural brain damage from an autoimmune encephalitis that impairs behavior in ways that are somewhat similar to the effects of "angel dust". The body sometimes makes substances that have effects on the brain in ways that resemble the effects of illicit drugs. In their paper, the authors report findings on a syndrome called anti-NMDA receptor encephalitis that arises when the body makes antibodies that target one of the subunits of the N-methyl-D-aspartate (NMDA) subtype of receptor for the chemical messenger, glutamate. The antibodies appear to mimic effects produced by the drug phencyclidine (PCP), also known as "angel dust", which produces a schizophrenia-like syndrome by blocking the NMDA glutamate receptor. Schizophrenia itself is also associated with NMDA receptor dysfunction. Senior author of the study, Dr. Carsten Finke, Professor at Charité-Universitätsmedizin Berlin, explains, "Anti-NMDA receptor encephalitis is a recently discovered autoimmune disorder of the brain, which causes a severe neuropsychiatric syndrome with behavioral changes, psychosis, memory loss, and decreased levels of consciousness. Although many patients recover well, the majority suffer from long-term cognitive impairment." (medicalnewstoday.com 26.4.2016).)

(Anm: Autoimmune attack underlying kidney failure. Interstitial nephritis, a common cause of kidney failure, has a complex and largely unknown pathogenesis. In a new published paper in The Journal of the American Society of Nephrology, a team of researchers led from Karolinska Institutet shows how interstitial nephritis can develop from an autoimmune attack on the kidney's collecting duct. (medicalnewstoday.com 24.3.2016).)

(Anm: Imbalance between gut microorganisms, immune cells could set stage for autoimmune disease. An imbalance in the reciprocal relationship between common gut bacteria and certain immune cells can set the stage for the development of autoimmune inflammation, according to a study conducted by researchers at Children's Hospital of Pittsburgh of UPMC and the University of Pittsburgh School of Medicine, who described their findings recently in Immunity. (...) (medicalnewstoday.com 18.3.2016).))

(Anm: Cellfälla nytt vapen mot autoimmuna sjukdomar. En fälla som fångar in celler som eldar på inflammationer i kroppen: Den nya svenska metoden att behandla autoimmuna sjukdomar kan komma ut på klinikerna nästa år. Först ut är ulcerös kolit. (…) Dit hör tarmsjukdomarna ulcerös kolit och Crohns sjukdom, MS, psoriasis samt förlamningssjukdomen ALS. (nyteknik.se 4.2.2016).)

(Anm: Systemic lupus erythematosus The Lancet 2014 (Early Online Publication, 30 May 2014).)

(Anm: Sertraline (Zoloft)-indusert systemisk lupus erythematosus (SLE) (Lupus) (Sertraline Induced Systemic Lupus Erythematosus) (The Internet Journal of Internal Medicine 2005;6(1).)

- Dødsrater for Lupus forblir høye i USA.

(Anm: Lupus Death Rates Remain High in U.S. Drop in SLE death rates less than non-lupus mortality. Despite improving trends in mortality, death rates from systemic lupus erythematosus (lupus) remain high compared with those in the general population, and disparities persist between subpopulations and geographic regions, according to a report in the Annals of Internal Medicine. (medpagetoday.com 6.11.2017).)

– Studien viser hvordan vanlig trening, stressreduksjon kan føre til bedre helse hos lupus pasienter.

(Anm: Study shows how regular exercise, stress reduction could lead to better health in lupus patients. Study shows how regular exercise, stress reduction could lead to better health in lupus patients (news-medical.net 19.9.2017).)

(Anm: Lupus Patients at Risk for Stroke. Risks high for women, the young, and during the year after diagnosis. Systemic lupus erythematosus (SLE) patients are more likely to experience ischemic and hemorrhagic stroke than the general population especially in the first year they are diagnosed, according to new research published in Annals of the Rheumatic Diseases. (medpagetoday.com 23.4.2017).)

(Anm: Lupus: Probiotics could help to reduce kidney inflammation. (…) Researchers have found that adding Lactobacillus to the diets of mice with lupus-induced kidney inflammation - also known as lupus nephritis - led to improvements in kidney function and increased their survival, but only in female mice. (…) Study co-author Xin Luo, from the Department of Biomedical Sciences and Pathobiology at Virginia-Maryland College of Veterinary Medicine at Virginia Tech, and colleagues recently reported their results in the journal Microbiome. (medicalnewstoday.com 3.10.2017).)

(Anm: Researchers discover that beneficial bacteria in yogurt may affect severity of lupus (news-medical.net 3.10.2017).)

(Anm: Antifungals and probiotics could play critical role in potential new therapeutic approaches for IBD. (news-medical.net 5.10.2017).)

(Anm: Financial Strain Tied to Depression in Women with SLE. Survey: 40% of those reporting high money pressures developed depression. High financial strain nearly doubles the risk of incident depression in women with systemic lupus erythematosus (SLE). In an analysis of data from the Lupus Outcomes Study, financial strain was the only significant socioeconomic predictor of incident depression, reported Patricia P. Katz, PhD, from the University of California, San Francisco, and colleagues in Arthritis Care & Research. (medpagetoday.com 26.4.2017).)

(Anm: For lupus patients, anti-inflammatory immune cells are maturing Into wrong cell type (medicalnewstoday.com 9.3.2016).)

(Anm: Slideshow: Thyroid Symptoms and Solutions (webmd.com 15.4..2014).)
(Anm: 15 Cancer Symptoms to Know (webmd 28.3.2016).)
(Anm: Slideshow: Causes of Fatigue and Sleepiness and How to Fight Them. (webmd).)
(Anm: Slideshow: A Visual Guide to Fibromyalgia (webmd.com 10.11.2014).)
(Anm: Slideshow: A Visual Guide to Understanding Lupus (webmd.com 2.2.2016).)
(Anm: Gout Pictures Slideshow: Causes, Symptoms, and Treatments of Gout (webmd.com 3.2.2016).)
(Anm: Slideshow: What Your Nails Say About Your Health (webmd.com 8.4.2014).)
(Anm: Sinusitis Slideshow: Symptoms, Diagnosis, Treatment (webmd 8.12.2014).)
(Anm: What Your Skin Says About Your Health Slideshow. (webmd.com 2.2.2016).)
(Anm: Type 2 Diabetes Overview (webmd.com 2.2.2016).)
(Anm: What Eye Problems Look Like (webmed).)

(Anm: Management of interstitial lung disease associated with connective tissue disease. (…) Shrinking lung syndrome. (…) Systemic lupus erythematosus. BMJ 2016;352:h6819 (Published 24 February 2016).)

(Anm: Suicidal Thoughts Seen as Risk in Lupus. —Common among lupus patients with neuropsychiatric manifestations (medpagetoday.com 24.9.2015).)

(Anm: Mitokondriell dysfunksjon (mitokondriedysfunksjon) indusert av sertraline (Zoloft), et antidepressiva (Mitochondrial dysfunction induced by sertraline, an antidepressant agent) Toxicol Sci. 2012 Jun;127(2):582-91. Epub 2012 Mar 2.)

(Anm: Kan Lupus øke risikoen for demens? Could lupus raise dementia risk? People living with lupus may be at significantly greater risk of developing dementia than those without the autoimmune disease, a new study suggests. (…) Study co-author Daniela Amital, of the Sackler Faculty of Medicine at Tel Aviv University in Israel, and colleagues recently reported their results in the International Journal of Geriatric Psychiatry. (medicalnewstoday.com 9.11.2017).)

(Anm: Effekten av tramadol, klonazepam og deres kombinasjoner på hjernens mitokondrielle komplekser. (Effects of tramadol, clonazepam, and their combination on brain mitochondrial complexes.) (…) Dette resultatet forklarer de kliniske og deres respektive histopatologiske effekter av tramadol, for eksempel anfall og røde nevroner (markør for apoptose). (The results showed that groups that received tramadol (therapeutic and abuse) suffered from weight loss.) (Toxicol Ind Health. 2015 Dec;31(12):1325-33).)

(Anm: Antibiotika kan utløse mitokondriell dysfunksjon som induserer psykiatriske lidelser. (Antibiotics May Trigger Mitochondrial Dysfunction Inducing Psychiatric Disorders. Med Sci Monit. 2017 Jan 7;23:101-106.)

(Anm: PET Imaging of Mitochondrial Complex I with 18F-BCPP-EF in Brain of Parkinson's Disease Model Monkey. (…) CONCLUSION: 18F-BCPP-EF has potential as a PET probe for the quantitative imaging of MC-1 damage in the living brains of PD model monkeys using PET. J Nucl Med. 2016 Feb 11. pii: jnumed.115.169615. [Epub ahead of print].)

(Anm: Drug-induced mitochondrial dysfunction and cardiotoxicity. Am J Physiol Heart Circ Physiol. 2015 Sep 18:ajpheart.00554.2015. [Epub ahead of print].)

(Anm: Role of altered mitochondria functions in the pathogenesis of systemic lupus erythematosus.Lupus. 2015 Sep 18. pii: 0961203315605370. [Epub ahead of print].)

(Anm: Sykdommen som får kroppen til å angripe seg selv. Lupus rammer kvinner ni ganger så ofte som menn. (…) - Tilstanden er vanligst blant kvinner som er i 20- til 40-årene, sier Eide. Menn med lupus kan se ut til å bli oftere angrepet i nyrene enn kvinner med sykdommen, og man kan også oftere se endringer i blodbildet (hemolytisk anemi, lavere antall blodplater eller lavere antall lymfocytter) hos menn. (klikk.no 17.4.2017).)

(Anm: Mitochondrial dysfunction related to cell damage induced by 3-hydroxykynurenine and 3-hydroxyanthranilic acid: non dependent-effect of early reactive oxygen species production. Neurotoxicology. 2015 Aug 5. pii: S0161-813X(15)00118-7. [Epub ahead of print].)

(Anm: Sertraline use during pregnancy and the risk of major malformations. OBJECTIVE: Given the current debate and growing public concerns on selective serotonin reuptake inhibitors (SSRIs) and birth defects generated by Food and Drug Administration warnings, we aim to quantify the association between first-trimester exposure to sertraline, a first-line treatment, and the risk of congenital malformations in a cohort of depressed women. (…) CONCLUSION: Sertraline use during the first trimester of pregnancy was associated with an increased risk of atrial/ventricular defects and craniosynostosis above and beyond the effect of maternal depression. Nonsertraline SSRIs were associated with an increased risk of craniosynostosis and musculoskeletal defects.Am J Obstet Gynecol. 2015 Jun;212(6):795.e1-795.e12. Epub 2015 Jan 28.)

(Anm: Memory immune cells that screen intruders as they enter lymph nodes (medicalnewstoday.com 3.4.2015).)

(Anm: Scientists find clues into cognitive dysfunction in chronic fatigue syndrome (medicalnewstoday.com 3.4.2015).)

(Anm: Misdiagnosis common in rheumatologic diseases like lupus (medicalnewstoday.com 20.8.2014).)

Elephant Man drug victims told to expect early death (timesonline.co.uk 30.7.2006)
timesonline.co.uk 30.7.2006 (The Sunday Times)
VICTIMS of the disastrous “Elephant Man” drugs trial have been told they face contracting cancer and other fatal diseases as a result of being poisoned in the bungled tests.

One of the six victims was told last week he is already showing “definite early signs” of lymphatic cancer.

He and three others have also been warned that they are “highly likely” to develop incurable auto-immune diseases.

The men were paid £2,000 each to volunteer as human “guinea pigs” in the trial at Northwick Park hospital, northwest London, last March. They suffered heart, liver and kidney failure and were left seriously ill after being given TGN1412. The drug was made by TeGenero, a German firm.

The men had been told by doctors they would not suffer any life-threatening illnesses.

Nav Modi, 24, whose bloated face and swollen chest led to the nickname “Elephant Man”, said he did not know how long he would live.

“It’s a really bizarre feeling when you discover you might be dead in a couple of years or even in a couple of months,” he said. “I feel like I’ve given away my life for £2,000.”

Modi’s lawyer, Martyn Day, of Leigh Day solicitors, said the four victims he was representing were considering legal action against Parexel, the firm that ran the trial. He believes they are eligible for up to £5m in damages. The company denies responsibility for the outcome of the trial.

The Sunday Times has seen the medical assessment of four of the victims, completed last week by immunologist Professor Richard Powell.

According to Powell, one man, known simply as Patient A, “has definite early signs that a lymphoid malignancy is developing”. (...)

(Anm: Autoimmune attack underlying kidney failure. Interstitial nephritis, a common cause of kidney failure, has a complex and largely unknown pathogenesis. In a new published paper in The Journal of the American Society of Nephrology, a team of researchers led from Karolinska Institutet shows how interstitial nephritis can develop from an autoimmune attack on the kidney's collecting duct. (medicalnewstoday.com 24.3.2016).)

Testperson förlorade alla sina fingrar och tår
svd.se 26.6.2006
Ryan Wilson skulle dryga ut kassan och ställde upp som föröksperson när en ny medicin skulle testas. Priset: han fick amputera samtliga sina tår och fingrar.

20-årige Ryan Wilson återvänder hem i morgon efter fyra månader på sjukhus, skriver The Mirror. Det var ett misslyckat läkemedelstest som skadade sex unga män så allvarligt att de fick läggas in på sjukhus. I Ryan Wilsons fall ledde det till att samtliga hans fingrar och tår fick amputeras. (...)

Opsvulmede mænd var ofre for sjusk
bt.dk 17.5.2006
(...) Stoffet, som det tyske biotekfirma TeGenero forsikrede kunne passe som en legoklods på et protein i de seks menneskekroppe, passer ikke alligevel.

Det hævdede firmaet ellers i sin ansøgning til de britiske lægemiddelmyndigheder. Da forsøgspersonernes modtog stoffet gik deres immunforsvar amok og var ved at tage livet af dem.

Afsløringen kommer fra to lektorer i biomedicin fra Syddansk Universitet, Søren Hansen og Graham Q.

Leslie, der har offentliggjort forklaringen i det seneste nummer af det videnskabelige tidsskrift Nature.

De anbefaler, at reglerne for godkendelse af nye lægemidler bliver ændret.

Problemet er, at de lægemidler, TeGenero og andre biotekfirmaer arbejder med, nemlig antistoffer, angriber så specifikke områder i vores kroppe, at der bør stilles større krav, inden man forsøger sig på mennesker. Søren Hansen siger, at 'sandsynligheden for, at det går galt igen, er stor, ud fra de retningslinjer der i dag foreligger'. (...)

(Anm: TGN1412: scrutinizing preclinical trials of antibody-based medicines. Nature. 2006 May 18;441(7091):282.)

Drug trial victims given £10,000
bbc.co.uk 27.4.2006
Four of the volunteers who were taken seriously ill during a drugs trial have been given unconditional interim payments of £10,000.

Their lawyer said the money was given by insurers to help in the short term. (...)

Drug trial victims offered £5,000
bbc.co.uk 19.4.2006
The men suffered multiple organ failure
Six volunteers who were taken seriously ill during a drugs trial have been offered an interim payment of £5,000, if they agree not to sue. (...)

Man Suffers Reactions After Drug Test
washingtonpost.com 15.4.2006
-- A 20-year-old man who suffered severe reactions during testing of a drug intended to treat autoimmune diseases and leukemia said he will lose parts of his fingers and toes.

Ryan Wilson was among six healthy volunteers who took part in the clinical trial and suffered convulsions and organ failure minutes after being administered the test drug TGN1412. All the other volunteers have been released from the hospital.

"I'm definitely going to lose bits of my fingers and toes. And they say I could be in here for another six months," he told the News of the World.

"I'm told it's like frostbite and my fingers will just fall off."

Large parts of Wilson's hands and feet have turned black, where flesh has died, according to pictures published in the newspaper.

Wilson plans to sue the drug maker TeGenero AG of Wuerzburg, Germany, and Waltham, Mass.-based Parexel International, which conducted the trials. (...)

(Anm: What is leukemia? - Danilo Allegra and Dania Puggioni (ed.ted.com).)

Drug trial man's 'brain on fire'
bbc.co.uk 31.3.2006
The men were all treated at Northwick Park Hospital
One of six men who fell seriously ill after taking part in a drug trial has told the Sun newspaper he felt like his brain was "on fire".

Drugs trial man 'making progress'
bbc.co.uk 26.3.2006
The same drug made monkeys' glands swell

One of the two men left critically ill by a drugs trial almost two weeks ago is reported to be making good progress. (...)

The case is being investigated by the Medicines and Healthcare products Regulatory Agency (MHRA), which seized documents and sealed off offices.

Scotland Yard said officers were talking to the MHRA and doctors.

TeGenero, som utviklet legemidlet, sa TGN1412 hadde forårsaket oppsvulming av kjertelene til to aper i tidligere tester, men sa symptomene var forskjellig fra dem som ble observert i mennenes tilfeller. (...) (TeGenero, which developed the drug, said TGN1412 had caused the glands of two monkeys to swell in earlier tests, but said the symptoms differed from those seen in the men's cases.)

SuperMAB on trial (SuperMAB)
Editorial
The Lancet 2006; 367:960
A phase 1 trial has resulted in six men becoming seriously ill in Northwick Park Hospital, London, UK. On March 13, six volunteers received the test drug and two were given placebo in a first-in-man trial of TeGenero's TGN1412, an immunomodulatory humanised agonistic CD28 monoclonal antibody that was being developed for treatment of leukaemia, rheumatoid arthritis, and multiple sclerosis. Within hours of receiving the test drug, all six men were admitted to intensive care with a severe inflammatory reaction and multi-organ failure. Two remain critically ill. The two men who received placebo described how their co-volunteers “went down like dominoes”. (...)

Until the MHRA and police investigations are complete, it is unclear whether there was a fault with the quality of the drug, contamination, a deviation from the protocol, or whether this was an unpredicted adverse event. Although most first-in-man trials are not associated with such dreadful events, the fact that they have occurred should lead to maximum transparency to reaffirm trust in clinical trials and their regulation. Commercial confidentiality should not obstruct independent scrutiny of the TGN1412 protocol and trial conduct. (...)

Fatalt fase 1-forsøg kan føre til strammere lovgivning
dagenspharma.dk 19.1.2016
EU skærpede sidst reglerne for fase 1-forsøg efter TeGenero-katastrofen i London i 2006. Spørgsmålet er, om den aktuelle sag fra Frankrig vil føre til yderligere stramninger

Et fase 1-forsøg i London med proteinmolekylet CD28 udviklede sig i 2006 katastrofalt. Seks raske unge mandlige forsøgspersoner fik livstruende reaktioner og varigt mén efter forsøgsbehandling med CD28 i sagen, der siden er blevet kendt som TeGenero-sagen, navngivet efter det nu lukkede firma, som stod lægemiddelkandidaten. TeGenero-sagen førte i 2007 til en skærpelse af det […]

Risky business: Human testing for a profit
msnbc.msn.com 24.3.2006
New scrutiny needed after two commercial clinical trials go wrong

DRUG TRIALS: Violent Reaction to Monoclonal Antibody Therapy Remains a
Mystery

SCIENCE 2006;311:1688 (March 24)
CAMBRIDGE, U.K.--On 13 March, six healthy volunteers in a clinical trial
were injected with a "superagonist," a drug meant to boost a type of T cell in the immune system, and soon all of them became violently ill. Exactly
what triggered the reaction is not known.

Svåra biverkningar i engelsk läkemedelsstudie
Läkemedelsverket 17.3.2006
I media rapporteras om att sex friska försökspersoner i en klinisk läkemedelsstudie blivit allvarligt sjuka. Eftersom studien inte har granskats av Läkemedelsverket har vi mycket begränsad information om försöksläkemedlet och studien. Det som framkommit sammanfattas här.

Studien som genomfördes i England var avsedd att studera effekten av en antikropp, som verkar via en receptor, CD28, på vissa immunreglerande celler. Antikroppen utvecklades i syfte att dämpa immunsystemet och en tänkt framtida användning var behandling av reumatoid artrit, multipel scleros och vissa cancerformer.

Mekanismen bakom det svåra sjukdomstillståndet är inte klarlagt. Det förefaller dock som om det uppstått en mycket kraftig inflammatorisk reaktion istället för en dämpning av immunsystemet.

Läkemedlet har inte studerats i Sverige och inte heller någon substans med samma verkningsmekanism.

Parexel in hot water over drug trial scare
outsourcing-pharma.com 16.3.2006
- Parexel, one of the world’s leading clinical research organisations is under investigation after six men in a UK drug trial being run by the company were admitted to intensive care on Tuesday. The scare is sending shockwaves throughout the clinical trials industry, where over 30 per cent of Phase I-III trials are outsourced, and will make it even harder to recruit study subjects in an industry that is already struggling to do so.

The drug behind the fury is called TGN1412, a monoclonal antibody being developed by Germany's TeGenero to treat conditions including multiple sclerosis, rheumatoid arthritis and leukaemia.

Parexel, which owns and operates the dedicated clinical research facility unit at the Northwick Park Hospital where the trial took place, was running the Phase I clinical trial under a contract with TeGenero.

A Phase I trial tests a drug for the first time in a small group of healthy human volunteers to determine the drug's activity, including any potential side-effects.

Eight men took part in this stage of the clinical trial; six were given the product and two were given a placebo.

Drugs volunteer's 'living hell'
bbc.co.uk 16.3.2006
One of the men given a dummy pill as part of the clinical trial that left six men seriously ill has said the study was like "Russian roulette".

Drug trial hell: 'He was like the elephant man'
dailymail.co.uk 16.3.2006
Reader comments (43)
Horrific stories have emerged of the drugs trial on human guinea pigs which went disastrously wrong.

Kjemper for livet etter medisintest
dn.no 15.3 2006
Seks menn kjemper for livet på et sykehus i London etter at de deltok i en test av en ny medisin.

Fikk elefanthode etter medisintest
dagbladet.no 15.3.2006
KJENNER IKKE IGJEN KJÆRESTEN: Myfanwy Marshalls kjæreste er innlagt på sykehus etter å ha testet medisin.

Tilstanden kritisk for to menn. Fire andre alvorlig skadd.

To menn ble mandag innlagt på intensiv avdeling på Northwick Park Hospital i London etter å ha fått bivirkninger som følge av et medisinsk eksperiment utført av amerikanske Parexel.

Et av ofrene, som opplevde at hodet og hender vokste til tre ganger normal størrelse, ble beskrevet av en venn som elefantmann, ifølge CNN.

Det var totalt åtte menn som meldte seg frivillig til å teste medisinen. Seks er innlagt på sykehus. De to siste fikk placebo-medisin og er uskadd.

- Livet er ødelagt
Medisinen skal blant annet behandle leukemi.
- Min sønn er en sunn gutt. Han røyker ikke, drikker lite og var godt trent, inntil de ødela livet hans, sier moren til et av ofrene til CNN.
Kjæresten til et av ofrene, en mann på 28 år, kjente nesten ikke igjen sin kjære etter at han ble syk.

- Han ser ut som elefantmannen, sa Myfanwy Marshall tidligere idag.

Svært sjelden
- En slik reaksjon skjer svært sjelden og er en uheldig og uvanlig situasjon, sa Dr. Herman Scholtz, sjef for Parexel International Clinical Pharmacology, i en uttalelse.

- Vi har standard prosedyrer som alltid brukes den første gangen vi tester ny medisin på mennesker, sier Scholtz.
Parexel sier at medisinen var utviklet av tyske TeGenero.
- Disse hendelsene var helt uventet og gjenspeiler ikke resultatene vi fikk fra laboratoriumsprøver som vi tok før vi fortsatte med forskning på mennesker, sier TeGenero i en uttalelse.

- De troede hovedet ville eksplodere!

- De troede hovedet ville eksplodere!
bt.dk 17.3.2006
23-årige Raste Khan var heldig. Han fik snydemedicin forleden, da seks andre faldt om som domino-brikker, da de testede en ny medicin. De to svæver fortsat i livsfare.

- Jeg takker min Gud for, at det var mig, der fik snydemedicinen, for da jeg så hvad der skete med de andre, ja så fik jeg et chok.

Det siger 23-årige Raste Khan til den engelske avis The Sun.

- Jeg og en anden fik altså ikke den test-medicin som de øvrige. Vi mærkede derfor intet. Men vi oplevede, hvordan de seks andre begyndte at...

...svede. De tog deres tøj af, og nogle klagede over, at de fik feber.
Andre skreg, at de følte, at deres hoved ville eksplodere. Jeg var selv ved at gå i panik, for på det tidspunkt vidste jeg ikke, at jeg havde fået snydemedicin - og derfor troede jeg, at jeg i løbet af få minutter også ville få det skidt.

Så heldig var 35-årige Myfanwy Marshalls kæreste ikke. Hendes 28-årige kæreste svulmede op til det ugenkendelige.

- Han hævede og hævede. Han kunne til sidst slet ikke se ud gennem øjnene, og han lignede Elefantmanden. Lægerne fortalte mig, at kun et mirakel kan redde hans liv, fortæller Marshall opgivende og rystet.

For 21-årige Ryan Flanagan er situationen også fortsat kritisk. Han kan ikke trække vejret ved egen hjælp, og hoved samt nakke er svulmet op til tre gange normal størrelse, fortæller familien til avisen.

Familierne til de ramte er stærk utilfreds med de bulletiner, de har fået fra medicinselskabet TeGenero, som har været stærkt modstridende.

Imens venter familierne spændt, mens lægerne kæmper desperat for at redde test-personernes liv.

HIV/Aids

GSK halts all tests on HIV/Aids treatment (GSK stanser alle tester på HIV/Aids behandling)
The Times 26.10.2005
UTVIKLINGSARBEID for et av de mest lovende behandlinger mot HIV/Aids på år og dag er stoppet etter et siste forsøk avdekket nye sikkerhetsproblemer. (DEVELOPMENT work on one of the most promising treatments for HIV/Aids sufferers in years has been stopped altogether after a last-ditch trial uncovered fresh safety problems.)

GlaxosmithKline sa i går at ingen ytterligere forsøk på Aplaviroc er planlagt etter at tester på en pasient linket det nye legemiddel til alvorlig leverskade. (...) (GlaxosmithKline said yesterday that no further clinical trials of Aplaviroc were planned after tests on a patient linked the novel medicine to severe liver damage.)

Innflytelsesrikt statlig panel foreslår å bruke innsatte i legemiddelforsøk

Panel Suggests Using Inmates in Drug Trials (Panel foreslår å bruke innsatte i legemiddelforsøk)
nytimes.com 13.8.2006
Several government agencies and private companies tested pharmaceuticals on inmates at Holmesburg prison in Philadelphia from 1951 to 1974.

PHILADELPHIA, Aug. 7 — An influential federal panel of medical advisers has recommended that the government loosen regulations that severely limit the testing of pharmaceuticals on prison inmates, a practice that was all but stopped three decades ago after revelations of abuse. (...)

Legemidler mot depresjon - liten eller ingen effekt

Tvivl om antidepressiv medicin
videnskab.dk 21.9.2009
En kritisk artikel i det højt ansete, videnskabelige tidsskrift The New England Journal of Medicine har sat spørgsmålstegn ved effekten af 'lykkepiller'. (...)

Kun positive resultater publiceret
Faktisk var der nøjagtig lige mange undersøgelser med positive resultater (36), som med direkte negative resultater (24) samt tvivlsomme resultater (12), der hverken var klart positive eller negative med hensyn til en tydelig virkning af den antidepressive medicin. (...)

Resultater 'fordrejet'
Det amerikanske forskerhold bag den omtalte kritiske gennemgang af forskningen vedrørende effekten af antidepressiv medicin mener altså, at resultaterne bliver "fordrejet" i en retning til fordel for medicinalindustrien, der producerer denne medicin, dels ved at negative resultater holdes skjult, og dels ved at negative eller tvivlsomme resultater fremstilles som om de var positive, selvom det - ifølge forskerholdets egne analyser - ikke var tilfældet. (...)

Drug Trial Shows Some Gains Against Major Depression
healthfinder.gov 1.9.2006
But the benefits were relatively small, indicating need for newer medications.

(...) "These were the hard cases, so getting even 10 percent of them well was pretty good," said study author Dr. Patrick J. McGrath, co-director of the Depression Evaluation Service at New York State Psychiatric Institute and Columbia University Medical Center in New York City. "The bad news is that those rates are pretty low, so we do need better treatments." (...)

(...) The study findings were published in the September issue of the American Journal of Psychiatry. (...)

(Anm: Spørsmålet er kanskje om de forskere, som har publisert resultater som viser en positiv effekt på opp mot 60-90 % for SSRI-er over placebo, bør granskes for mulig forskningsjuks.)

- Dyreforsøk - kan forskningsbevis fra dyr overføres til mennesker?

Model behaviour
Nature 2007;450, 6-7 (31 October)
The brain is no longer the black box it used to be, and neuroscientists are starting to put new knowledge to good use, developing better animal models for psychiatric disorders. (...)

Dangle a mouse by its tail, and it will wriggle and strain to escape before eventually recognizing the hopelessness of its situation. Measure the time it takes to abandon thoughts of helping itself, and you have one of the classic animal tests for depression.

Except it's not, says Laurence Tecott, a research psychiatrist at the University of California, San Francisco. “We can't say that that mouse is depressed, and we can't say you would be if you were strung up by your tail,” he says. The reason we have not seen a genuinely new class of drug in psychiatry for 50 years, he asserts, is largely because animal models are woefully inadequate representations of human-specific disorders. (...)

(Anm: Are animal models still essential to biological research?. (medicalnewstoday.com 4.8.2015).) 

Studies in animals should be more like those in humans
BMJ 2007;334:274 (10 February)
Animal testing
The settings of animal studies are very different from those of therapeutic studies in human patients.1 They need to be more similar. (...)

Translating animal research into clinical benefit
Editorials
BMJ 2007;334:163-164 (27 January)
Poor methodological standards in animal studies mean that positive results rarely translate to the clinical domain (...)

You don't want noisy protesters outside your animal lab? Outsource the work to you-know-where
forbes.com 13.11.2006
You need a thick skin to run an animal testing lab in the U.S. Ask Huntingdon Life Sciences (other-otc: HTDLY.PK - news - people), the East Millstone, N.J. firm on the hit list of a group called SHAC, or Stop Huntingdon Animal Cruelty. SHAC has harassed everyone from company execs down to workers, customers and suppliers. (...)

What to do? Outsource animal testing to China, where scientists are cheap, lab animals plentiful and pesky protesters held at bay. Glenn Rice, chief executive of Bridge Pharmaceuticals, a contract research organization in the San Francisco Bay area, is pioneering this migration to China. "Animal testing does not have the political issues it has in the U.S. or Europe or even India, where there are religious issues, as well. So now big pharma is looking to move to China in a big way," says Rice, 50, who spun Bridge out of sri International in Menlo Park, Calif. in 2004. And China is welcoming it. Bridge, situated in the lush sprawl of the city's Zhongguancun Life Science Park, has been given "big benefits and a five-year tax holiday" for being there, says Rice. (...)

Pharma majors Roche, Pfizer (nyse: PFE - news - people) and Eli Lilly (nyse: LLY - news - people) all have announced plans recently to set up research units in China. Midsize pharmaceuticals that can't afford similar setups are increasingly looking to outsource their animal testing (or "preclinical trials") to companies such as Bridge. (...)

"Unfortunately there is no substitute to testing on live animals," says Rice. "The test tube is just not as dynamic as the physiology in the body. If we stopped animal testing, drug development would stop short." (...)

Rice admits that Chinese testing companies lack quality control and high standards on treatment. That's why, he says, he hired American executives to run the operations in China. Bridge, he insists, isn't in China to take "shortcuts on animal welfare." (...)

Resultater fra forsøgsdyr kan snyde
dtu.dk 5.10.2006
Ny opdagelse afslører, at resultater fra forsøgsdyr kan snyde

Medicin, der virker på forsøgsdyr, virker ikke nødvendigvis på samme måde i mennesker. Forskere fra Danmarks Tekniske Universitet (DTU) har fundet afgørende forskelle i den måde som celledelingen styres på i modelorganismer og mennesker.

De banebrydende resultater, som i dag offentliggøres i det anerkendte videnskabelige tidsskrift Nature, ventes at få betydning for forskningen og udviklingen af ny medicin, som ofte er baseret på overførsel af resultater fra forsøgsdyr til mennesker. (...)

Translation of Research Evidence From Animals to Humans
JAMA 2006 296: p. 1731-1732 (October 11)
To the Editor: Most medical therapies in use today were initially developed and tested in animals,1 yet animal experiments often fail to replicate when tested in rigorous human trials.2-3 We conducted a systematic review to determine how often highly cited animal studies translate into successful human research. (...)

Legemiddelforsøk på barn

Blir pålagt å teste medisiner på barn
dagsavisen.no 5.12.2006
Fra nyttår forlanger EU at legemidler som skal gis til barn må være testet ut på dem. Det fører til flere legemiddeleksperimenter på mindreårige. (...)

Børneforsøg skal sikre bedre medicin
berlingske.dk 29.10.2006
Ny medicin til børn skal fremover være afprøvet på børn, før den kan blive godkendt i EUs lægemiddelagentur. I dag behandles børn, som om de var små voksne (...)

Halvdelen af den medicin, danske og europæiske læger skriver ud til Europas godt 100 mio. børn, er aldrig blevet testet på børn. Endsige godkendt til behandling af børn.

Den praksis skal der nu sættes en effektiv stopper for. EU-Parlamentet ventes sidst i november at vedtage en beslutning, der vil pålægge medicinselskaberne at gennemføre kontrollerede forsøg med børn som forsøgspersoner. (...)

Guleroden for medicinselskaberne bliver, at de får forlænget deres patentperiode for nye produkter med et halvt år, hvis de kan dokumentere, at et middel også er afprøvet på børn. (...)

- The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity

The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity
Opinion
by Dr. David Graham
globalresearch.ca 19.11.2006 (Global Research)
June 30, 2006 is a day that will be long remembered as a dark milestone in the history of FDA and its campaign against health consumers. On June 30, an FDA "Final Rule" goes into effect, establishing a regulatory power grab of such scale and scope that it attempts to bypass all laws, the will of Congress and fundamental protections for consumers. This "Final Rule," which may as well be called a "Final Solution" for drug consumers, claims that consumers can no longer sue drug companies for the harm caused by any FDA-approved drug, even if the drug's manufacturer intentionally misled the FDA by hiding or fabricating clinical trial data. (...)

In one blatantly illegal act, the FDA is attempting to pull off the greatest Big Pharma coup of all: The outright elimination of any responsibility whatsoever for the suffering and death caused by deadly pharmaceuticals. (...)

FDA-approved prescription drugs injure 2.2 million and kill approximately 100,000 Americans each year, according to peer-reviewed published studies, and more realistic estimates put the number of deaths at over 200,000 people annually in the United States alone (see Death By Medicine for detailed statistics). Vioxx, according to senior FDA drug safety researcher Dr. David Graham, appears responsible for the deaths of over 60,000 Americans, and further deaths due to beta blockers, antidepressant drugs, statins and other medications continue to mount by the hour. (...)

Dr. David Graham is senior drug safety researcher at the Food and Drug Administration, and Vioxx whistleblower. (...)

- I vilken grad etterforskes og straffes legemiddelkriminalitet?

Oppgjør med kriminalitet
Aftenposten 18.9.2005
(...) Avklaring i retten er viktig fordi store uoppklarte forbrytelser har lett for å utvikle seg til samfunnssår som ikke vil gro. Ikke minst gjelder det en forbrytelse som helt åpenbart er et resultat av organisert, bevisst og nøye planlagt kriminalitet. Det er ingen impulshandling som ligger bak det som de kommende ukene rulles opp i Stavanger tingrett. (...)

Oppklaringen - så langt vi kjenner den i dag - har kostet enorme ressurser, både mannskapsmessige og økonomiske. De har vært vel anvendte. Det ville vært meget bekymringsfullt dersom ikke politiet hadde fått muligheter og rom til å oppklare en slik forbrytelse. Organisert kriminalitet er noe mer enn en enkeltstående handling. Den representerer et anslag mot de verdiene som vårt samfunn bygger på.

Hver enkelt av de 13 på tiltalebenken skal behandles individuelt, og hver enkelt sak skal prøves og veies for seg. Slik skal vår rettsorden fungere.

Likevel vil NOKAS-ranet gå inn i kriminalhistorien som noe mer enn en serie enkelthandlinger. Det representerer en påminnelse om hva kynisk organisert kriminalitet innebærer - og derfor også hvor viktig det er å bekjempe den. (...)

157,5 millioner ekstra til Nokas-saken

157,5 millioner ekstra til Nokas-saken
Justis- og politidepartementet 19.8.2005
Etter forslag fra Regjeringen har Stortinget hittil bevilget 124 millioner kroner ekstra i forbindelse med politiets, påtalemyndighetens, kriminalomsorgens og domstolens arbeid med Nokas-saken. Regjeringen har tatt initiativ til at det bevilges ytterligere 33,5 millioner kroner.

- Dette er riktige og viktige penger. Måten ranet skjedde på representerer et tidsskille i norsk kriminalhistorie. Og det er nødvendig å gjøre det klart at vi vil bruke de ressursene som er nødvendige for å få denne saken for domstolen, sier justisminister Odd Einar Dørum.

Med det siste bevilgningsforslaget er det totalt bevilget 157,5 millioner kroner i ekstra i forbindelse med Nokas-saken. De tidligere bevilgningene fordeler seg med 112,1 millioner kroner til politiet, 7,9 millioner kroner til kriminalomsorgen, 3,5 millioner kroner til domstolene og 0,5 millioner kroner til høyere påtalemyndighet.

I det nye forslaget er politiet tiltenkt 14,9 millioner kroner og domstolene 18,6 millioner kroner. (...)

- Et rettslig grunnlag for legemiddelsikkerhet

A legal framework for drug safety (Et rettslig grunnlag for legemiddelsikkerhet)
Editor's Choice
BMJ 2008;336 (15 March)
It’s welcome news that the UK government will close the legal loop hole that allowed GlaxoSmithKline to escape prosecution last week for not disclosing evidence of increased suicide risk in children taking seroxat (doi: 10.1136/bmj.39517.500961.DB). But this piece of legislation alone is not enough. It should be seen as just one further step on the legislative road to full mandatory disclosure of data from clinical trials.

There’s no mistaking the UK regulator’s frustration at having to drop its attempts to prosecute GSK. Staff at the Medicines and Healthcare products Regulatory Agency reviewed thousands of documents dragged out of GSK over four years. But in the end the existing EU legislation let them down: at the time it didn’t require companies to disclose adverse events from trials in groups of patients for whom the medicine was not licensed. On the basis of the same data but in a different legal framework, New York state successfully prosecuted GSK in 2004 for persistent fraud (BMJ 2004;329:590; doi: 10.1136/bmj.329.7466.590-d).

In his letter to GSK, Kent Woods, the MHRA’s chief executive, said it should be self evident that information on adverse effects should be made available promptly in order to protect the public’s health: "That moral responsibility now needs to be insisted upon by the unambiguous force of the law." (www.mhra.gov.uk/Howweregulate/Medicines/) (...)

UK government tightens rules on drug trial results (Britiske myndigheter strammer regler for resultater fra legemiddelforsøk)
BMJ 2008;336:576-577 (15 March)
The UK government is to increase drug companies’ responsibility to pass on information about clinical trials.

The move comes after the regulators announced last week that it could not prosecute GlaxoSmithKline (GSK) for non-disclosure of trial data that showed it was unsafe for children younger than 18 to take the antidepressant paroxetine (Seroxat). (...)

- Fremstående celecoxib-forsker innrømmer fabrikasjon av data i 21 artikler

Doctor Pleads Guilty to Research Fraud Involving Vioxx and Celebrex (Lege erklærer seg skyldig i forskningssvindel som involverer Vioxx og Celebrex)
pharmpro.com (23.2.2010)
BOSTON (AP) — A doctor accused of faking research for a dozen years in published studies that suggested after-surgery benefits from painkillers including Vioxx and Celebrex pleaded guilty Monday to one count of federal health care fraud.

An attorney for Dr. Scott Reuben said the anesthesiologist will have to repay $361,932 in research grants and forfeit assets worth at least $50,000 as penalty for his conduct following a plea hearing in U.S. District Court. (...)

Massachusetts Doctor Accused of Fraud by Faking Research (Lege fra Massachusetts anklaget for svindel ved å forfalske forskning)
pharmpro.com 15.1.2010
BOSTON (AP) — Federal prosecutors announced Thursday that they have filed a health care fraud charge against a doctor accused of faking research for a dozen years in published studies that suggested after-surgery benefits from painkillers including Vioxx and Celebrex.

Court documents indicate that Dr. Scott Reuben, an anesthesiologist, has agreed to plead guilty in exchange for prosecutors recommending a more lenient sentence of up to 10 years imprisonment, a $250,000 fine and forfeiture of assets worth at least $50,000 that Reuben received for the research.

Prosecutors allege the former chief of acute pain at Baystate Medical Center in Springfield sought and received research grants from pharmaceutical companies but never performed the studies. He fabricated patient data and submitted information to anesthesiology journals that unwittingly published it, court documents allege.

Reuben, a Longmeadow resident, took leave after the hospital said last year that a routine review found that some of his research was not approved by an internal hospital review board. Further investigation found 21 papers published in anesthesiology journals between 1996 and 2008 in which Reuben made up some or all data, the hospital said. Hospital officials said Reuben did not admit to the fabrications. (...)

US researcher fabricated pain studies (Amerikansk forsker fabrikkerte smertestudier)
pharmatimes.com 12.3.2009
One of the largest cases of academic fraud has come to light after it was revealed that a researcher in the USA fabricated data in at least 21 studies on pain drugs.

The work of Scott Reuben, an anaesthesiologist at Baystate Medical Center in Massachusetts, has been the subject of an investigation since May last year. It now appears that he never conducted the clinical trials that he wrote about in journals.

Specifically, Dr Reuben’s ‘research’ had promoted the notion of shifting from nonsteroidal anti-inflammatory drugs (NSAIDs) to the newer COX-2 inhibitors, such as Merck & Co’s Vioxx (rofecoxib) and Pfizer’s Celebrex (celecoxib), and Bextra (valdecoxib). He had argued that using these drugs in combination with Pfizer’s Neurontin (gabapentin) and Lyrica (pregabalin) could be effective in decreasing postoperative pain and reduce the use of addictive painkillers during recovery. (...)

(Anm: Massachusetts Doctor Accused of Fraud by Faking Research (pharmpro.com 15.1.2010).)

Prominent celecoxib researcher admits fabricating data in 21 articles (Fremstående celecoxib-forsker innrømmer fabrikasjon av data i 21 artikler)
BMJ 2009;338:b966 (9 March)
A well known researcher who promoted the use of the non-steroidal anti-inflammatory drug celecoxib has admitted fabricating data in 21 of his 72 articles indexed by PubMed. The case is "among the biggest which has come to light," said Harvey Marcovitch, chairman of the Committee on Publication Ethics, an international forum for publishers and editors of peer reviewed journals.
Scott S Reuben, chief of the acute pain service at Baystate Medical Center in Springfield, Massachusetts, has admitted the fraud, says a notice issued by the centre in late January. (...)

Dr Reuben, who received research grants from Pfizer, the US manufacturer of celecoxib (marketed as Celebrex), and served on its speakers’ bureau, pioneered "multimodal analgesia," the combination of celecoxib with another Pfizer drug, the anticonvulsant pregabalin (Lyrica). The combination, Dr Reuben claimed, was preferable to opioids, and it became a mainstay in pain management.

James Eisenach, editor in chief of Anesthesiology, said that Dr Reuben’s research was central to the claim that celecoxib reduces pain at six and 12 months after surgery. He said that the fraud creates a "hole" in pain research and casts doubt on claims about celecoxib.
Dr Eisenach says in an editorial to be published in the May 2009 issue of Anesthesiology (http://pdfs.journals.lww.com/anesthesiology/9000/00000/99939.pdf) that the retracted articles "have been considerably cited since 2002" and that mere retraction of the articles will not be enough. He says that the journal will use its peer review system "to assure that these articles are no longer cited by our authors." He also calls for "submission of studies reexamining the questions that seemed to be answered by Reuben in the retracted studies." (...)

- Legemiddelfirma anklaget for svindel

Antidepressant Marketing Tactics Lead to Federal Lawsuit (Salgsteknikk for antidepressiva førte til statlig søksmål)
Psychiatr News 2009;44(7):6 (April 3) (American Psychiatric Association)
Government prosecutors say the maker of citalopram and escitalopram concealed unfavorable clinical trial results from the public and bribed physicians with kickbacks to increase market share.

The U.S. Department of Justice has accused Forest Laboratories of conducting a "fraudulent scheme to market and promote" unapproved indications for its antidepressants citalopram and escitalopram and paying kickbacks to induce physicians to prescribe those medications. (...)

Drug Maker Is Accused of Fraud (Legemiddelfirma anklaget for svindel)
nytimes.com 25.2.2009
The Justice Department charged the drug maker Forest Laboratories on Wednesday with defrauding the government of millions of dollars by illegally marketing the popular antidepressants Celexa and Lexapro for unapproved uses in children and teenagers.

In a civil complaint filed by the United States attorney’s office in Boston, federal prosecutors alleged that former top executives at Forest concealed for several years a clinical study that showed that the drugs were not effective in children and might even pose risks to them, including causing some to become suicidal.

From 2001 to 2004, Forest heavily promoted results from another clinical trial it had financed that showed that the drugs were effective, without disclosing the negative study to those researchers, its own medical advisers or its sales representatives, the complaint said.

An official of Forest, which is based in Manhattan, said the company’s lawyers were reviewing the complaint and did not have an immediate comment. Celexa and Lexapro are two versions of the same drug, citalopram. The drugs are currently approved by the Food and Drug Administration only for adults. (...)

According to court papers, Forest was aware of two studies started in the late 1990s to help win F.D.A. approval for the use of Celexa to treat depression in children. (...)

(Anm: Serotonin syndrom (SS), kramper, parkinsonisme osv. (forhøyet kroppstemperatur) (mintankesmie.no).)

(Anm: Vitenskapens psykedelika-pushere. Stadig mer penger blir gitt til forskning på LSD, ecstasy og fleinsopp. (…) Forskningen har derfor flyttet bort fra dansegulvet og inn i laboratorier og terapirom. Nye forskningsgrupper etableres, sist ved Yale University, og i Norge har det det siste året dukket opp to studentforeninger i regi av interesseorganisasjonen Emmasofia, på Universitetet i Oslo og ved NTNU. (forskning.no 6.4.2016).)

- The Vioxx story really highlights the difference between marketing and informing

Vioxx Problems Known Years Before Recall
healthday.com 23.11.2009
Study points up weaknesses of drug approval process in United States, researcher says (...)

In a statement released Tuesday, Merck officials said this: "Merck believes the article published in The Archives of Internal Medicine in today's issue related to Vioxx used unreliable methods and reached incorrect conclusions."

"The first time Merck observed a difference in a placebo-controlled study was when it learned the results of the APPROVe study in September 2004. We voluntarily withdrew Vioxx from the market within a week of those results," the statement continued.

"Merck acted responsibly -- from researching Vioxx prior to approval in studies with approximately 10,000 patients to monitoring the medicine while it was on the market -- to voluntarily withdrawing the medicine when it did," the statement said. "Our decisions were based on the data from well-controlled clinical trials."
But the authors of the new study believe the Vioxx saga points to a larger problem, one that involves the drug approval process in the United States.

"One of the challenges in health care is to recognize these safety risks early," said lead researcher Dr. Joseph S. Ross, an assistant professor of geriatrics and palliative medicine at Mount Sinai School of Medicine in New York City. (...)

Bringing the FDA's Information to Market (Formidling av FDAs informasjon til markedet)
Arch Intern Med. 2009;169(21):1985-1987 (November 23)
Here is a challenge: Imagine you are asked to turn a new prescription drug into a blockbuster. The drug is approved by the US Food and Drug Administration (FDA) to treat arthritis pain. That is good news because the arthritis market is huge. But you face some big challenges. First, there are several over-the-counter drugs available that treat pain equally well and at one-fiftieth of the cost. Your only comparative advantage is that your drug causes less gastrointestinal tract (GI) bleeding than other arthritis pain medicines. But this reduction is not very big and only applies to a very small slice (probably <5%) of the market—people at high risk for GI bleeding. And, oh yes, your drug may triple the chance of myocardial infarction.

Do you think you could get physicians to prescribe your drug to over 20 million Americans? Could you achieve over $2 billion in annual sales? Well, the makers of Vioxx (Merck & Co Inc, Whitehouse Station, New Jersey) did just that—until the drug was pulled from the market.

Ross et al show how a cumulative meta-analysis might have led the FDA to halt sales of Vioxx in 2001, 3 years before Merck voluntarily stopped selling it. Doing so might have prevented thousands of myocardial infarctions. We applaud this study and hope that independent investigators will apply the same methods to other drugs to help answer important safety questions. But the article left us wondering, just how did Vioxx get so big and stay so big for so long?

-Vioxx-historien fremhever virkelig forskjellen mellom markedsføring og informasjon. Dersom leger og pasienter hadde hatt fakta hadde de hatt behov for en alkymist for å gjøre denne gråstein til gull, ikke en markedsføringsavdeling. (The Vioxx story really highlights the difference between marketing and informing. If physicians and patients had had the facts, it would have taken an alchemist, not a marketing department, to turn this lemon into gold.)

The problem is that when it comes to prescription drugs, a lot more effort goes into marketing than informing. It has been estimated that drug companies spend $30 billion to $50 billion a year on drug promotion (advertising, detailing visits, free samples, and other promotion techniques).1 That means that the industry can really get its message out. (...)

- The European Medicines Agency (EMA) (tidligere EMEA) (den europeiske legemiddelkontrollen)

Italian police arrest drug agency officials over alleged falsification of data
BMJ 2008;336:1208-1209 (31 May)
A scandal involving drug licences for cash has engulfed Italy’s drug regulatory agency, and leading officials have been arrested, along with people linked to major drug companies.

The most senior figure to have been arrested and held by the police in his own home ("arresto al domiciliaro") is Pasqualino Rossi, vice president of the Agenzia Italiana del Farmaco (AIFA), the Italian Agency for Pharmaceuticals. Dr Rossi is also one of Italy’s most senior representatives at the European Medicines Agency (EMEA).

Six drug company lobbyists have also been held. As the BMJ went to press, four people were in custody and three were under house arrest. Another individual wanted by the police was not in Italy.

Arrest warrants were issued after a Turin investigating judge, Sandra Recchione, saw a 700 page police report concerning alleged falsification, in return for cash payments, of clinical data needed for drug licences. (...)

Italian police arrest drug agency officials over alleged falsification of data
Correction for Day, BMJ 336 (7655) 1208-1209
BMJ 2008;336 (14 June), doi:10.1136/bmj.a302
Corrections
In this News article by Michael Day, we gave some wrong information about one of the officials arrested (BMJ 2008;336:1208-9, 31 May, doi: 10.1136/bmj.39591.450856.DB). In the second paragraph, we said that Pasqualino Rossi was vice president of the Agenzia Italiana del Farmaco (the Italian Agency for Pharmaceuticals) whereas in fact he is Italy’s acting representative on the European Medicines Agency’s Committee for Medicinal Products for Human Use. Additionally, after our article went to press, it was announced that the second (and only other) official of the agency to be arrested was released shortly afterwards because the arrest was apparently a mistake. (...)

Mutskandal i Italien
lakemedelsvarlden.se 27.5.2008
Italienska läkemedelsverket är inblandat i en stor mutskandal. Med hjälp av pengar har lobbyister från läkemedelsföretag fått igenom godkännanden av läkemedel trots brister i kliniska data. (...)

Åtalet är ett resultat av två års förundersökningar. En av de åtalade tjänstemännen på italienska läkemedelsverket är också representant i EMEA. En talesperson från EMEA säger till Pharmatimes att de är medvetna om anklagelserna och att de är i kontakt med italienska läkemedelsverket för att diskutera personens framtida uppdrag. (...)

- Legemiddelfirmaer setter folkehelsen i fare

US drug companies paid $15bn in fines for fraudulent marketing in past five years (Amerikanske legemiddelfirmaer betalte 15 milliarder dollar i bøter for straffbar markedsføring de siste fem år)
BMJ 2010; 341:c7360 (21 December)
Legemiddelfirmaers ulovlige markedsføring har økt i løpet av de siste fem år, hvilket ifølge Public Citizen, en uavhengig amerikansk vaktbikkjeorganisasjon, fører til store bøter når firmaer blir saksøkt. De har kalt legemiddelindustrien “den største bedrager av staten.” (Illegal marketing activities by drug companies have risen over the past five years, leading to major penalties when companies are prosecuted, says Public Citizen, an independent US watchdog organisation. It has called the drug industry “the biggest defrauder of the federal government.”)

Selv om rapporter om legemiddelfirmaers misgjerninger er rapportert tidligere, oppsummerer Public Citizens nye rapport situasjonen. (Although reports of drug companies’ misdeeds have been reported before, Public Citizen’s new report summarises the situation.)

Industritalsmenn sa at problemene lå bak dem og at industrien har fått strengere retningslinjer på plass. (Industry spokespeople said that the problems were behind them and that the industry had put stricter guidelines in place.)

Sidney Wolfe, direktør for Public Citizens helseforskningsgruppe, fortalte BMJ at legemiddelindustrien i løpet av de siste fem årene har gått forbi forsvarsindustrien og alle andre industrier i antall sivile og kriminelle forlik av handlinger mot den føderale regjeringen og statlige regjeringer. I rapporten fremgår at 165 legemiddelfirmaers forlik utgjør 19,8 milliarder dollar (£12.8bn; €15bn) i bøter i løpet av de siste 20 årene, 73 % av forlik og 75 % av bøtene skjedde i løpet av de siste fem årrene. (Sidney Wolfe, director of Public Citizen’s health research group, told the BMJ that in the past five years the drug industry moved ahead of the defence industry and all other industry sectors in the number of civil and criminal settlements of actions against the federal government and state governments. The report said that of 165 drug company settlements comprising $19.8bn (£12.8bn; €15bn) in penalties over the past 20 years, 73% of settlements and 75% of penalties occurred in the past five years.)

Dr. Wolfe sa at økningen i antallet av saker skyldes i hovedsak legemiddelfirmaenes sterke bruk av ulovlig markedsføringspraksis, slik som promotering av forskrivning av legemidler utenfor preparatomtale, og myndighetenes økte håndhevelse, som fikk mer innsideinformasjon fra varslere, som kan motta betydelige belønninger. (Dr Wolfe said that the rise in the number of cases was largely because of drug companies’ greater use of illegal marketing practices, such as the promotion of off-label uses of drugs, and increased enforcement by authorities, which were getting more insider information from whistleblowers, who can receive substantial rewards.)

Han uttalte, “Det eneste som kan stoppe dette er . . . dersom noen puttes i fengsel, fordi dette er kriminelle lovbrudd og de setter folkehelsen i fare.” (...) (He said, “The only way it will stop is . . . if someone goes to jail, because these are criminal violations and they endanger the public health.” )

Rapidly Increasing Criminal and Civil Monetary Penalties against the Pharmaceutical Industry: 1991 to 2010 is available at www.citizen.org/hrg1924. (...)

(Anm: Pharmaceutical Industry Is Biggest Defrauder of the Federal Government Under the False Claims Act, New Public Citizen Study Finds - Civil, Criminal Settlements Have Increased Dramatically; Off-Label Promotion Largely Responsible. (citizen.org 15.12.2010).)

(Anm: Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry: 1991 to 2010. (citizen.org 15.12.2010).)

Läkemedelsindustrin i fokus för utredningar om bedrägeri
lakemedelsvarlden.se 20.12.2010
Den amerikanska försvarsindustrin är inte längre den bransch som fälls för flest bedrägeri- och mutbrott. Enligt en ny rapport är det läkemedelsindustrin.

SKUMT Läkemedelsindustrin har gått om försvarsindustrin som det främsta målet för federala bedrägeriutredningar i USA. Det konstateras i en rapport från organisationen Public Citizen.

De senaste fem åren har branschen betalat närmare 15 miljarder dollar i böter och i uppgörelser med staten.

Studien omfattar brott mot marknadsföring samt bedrägeri mot Medicaid, det vill säga saltade räkningar till den statliga sjukvårdsförsäkringen.

De som betalat mest är GlaxoSmithKline, Pfizer, Eli Lilly och Schering-Plough som enligt rapporten stått för 10, 5 miljarder av de utbetalade böterna och uppgörelserna.

I några fall har företagen samtidigt som man tillbakavisat påståendena om bedrägeri och mutor, betalat ut stora summor i uppgörelser med regeringen i stället för att driva ärendena vidare.

Pfizer är det enskilda företag som hittills betalat ut mest. (...)

(Anm: Uredelighet og fusk (juks/forskningsjuks) i medisinsk forskning. (mintankesmie.no).)

- WikiLeaks-telegrammer: Pfizer "brukte skitne triks for å unngå utbetalinger for kliniske forsøk"

WikiLeaks cables: Pfizer 'used dirty tricks to avoid clinical trial payout' (WikiLeaks-telegrammer: Pfizer "brukte skitne triks for å unngå utbetalinger for kliniske forsøk")
guardian.co.uk 9.12.2010
Cables say drug giant hired investigators to find evidence of corruption on Nigerian attorney general to persuade him to drop legal action

The world's biggest pharmaceutical company hired investigators to unearth evidence of corruption against the Nigerian attorney general in order to persuade him to drop legal action over a controversial drug trial involving children with meningitis, according to a leaked US embassy cable.

Pfizer was sued by the Nigerian state and federal authorities, who claimed that children were harmed by a new antibiotic, Trovan, during the trial, which took place in the middle of a meningitis epidemic of unprecedented scale in Kano in the north of Nigeria in 1996.

Last year, the company came to a tentative settlement with the Kano state government which was to cost it $75m.

But the cable suggests that the US drug giant did not want to pay out to settle the two cases – one civil and one criminal – brought by the Nigerian federal government. (...)

Medicinalgigant bagvaskede justitsminister efter nigerianske børneforsøg
politiken.dk 10.12.2010
Detektiver skulle grave snavs frem for at stoppe retssag mod Pfizer, viser WikiLeaks-dokument.

Medicinalgiganten Pfizer, som blandt andet producerer potenspillen Viagra, brugte beskidte tricks for at stoppe en millionretssag i Nigeria efter kontroversielle medicinforsøg på børn.

Det viser et dokument fra den amerikanske ambassade i Nigerias hovedstad Abuja til Washington, som er blevet offentliggjort i forbindelse med den verserende WikiLeaks lækage i diplomatiske indberetninger.

Sagen drejer sig om kliniske medicinforsøg på 200 børn under en meningitis-epidemi i Kano i det nordlige Nigeria i 1996.

DOKUMENTATION Se Pfizer-dokumentet her (engelsk)

Efterfølgende lagde Nigeria sag an mod medicinalgiganten, fordi Pfizer ikke havde fået tilladelse til eksperimentialbehandling fra forældrene med medicinen, som i dag kun bruges i nødstilfælde i USA og er helt ulovlig i Europa.

Det var for at lægge pres på den nigerianske justitsminister Michael Aondoakaa og få ham til at droppe retssagen, at Pfizer greb til hårdhændede metoder. (...)

Pfizer sought corruption links to end Trovan case; WikiLeaks
in-pharmatechnologist.com13.12.2010
Pfizer hired investigators to expose corrupt behaviour of the former Nigerian attorney general to ‘pressure’ him to drop legal action against the contentious Trovan drug trial, according to a leaked US embassy cable.

The cable, released by whistle-blowing website WikiLeaks, outlines details of the Nigerian state and federal authorities’ lawsuit against the world’s largest drug company over the trial of the oral antibiotic, trovafloxacin, during the 1996 meningitis epidemic in Kano, north of Nigeria.

The trial involved 100 children with meningitis, and allegedly led to the deaths of 11 children and rendered dozens more disabled, however Pfizer denies these charges.

Last year, Pfizer reached a $75m (€57m) settlement with Nigeria’s Kano government, including a $10m payout for legal fees, $30m to the Kano state government, and $35m for the affected trial participants and families.

Yet the cable suggests the drug major was reluctant to hand out the money agreed to settle the two cases – one criminal and one civil – brought by the Nigerian federal government.

The cable reports a meeting on 9 April 2009 between Pfizer's country manager, Enrico Liggeri, and US officials at the Abuja embassy, during which Liggeri claimed “Pfizer had hired investigators to uncover corruption links to federal attorney general, Michael Aondoakaa to expose him and put pressure on him to drop the federal case.”

Liggeri said Pfizer’s investigators handed over evidence of alleged corruption, but had “much more damaging information” on Aondoakaa that they refrained from passing on to the local media. The information was intended to be used to raise fears that additional negative articles being published. (...)

Diverse artikler

Serious adverse events rare in healthy volunteers participating in Phase I drug trials
pharmpro.com 7.7.2015
PHILADELPHIA - Many people believe that phase I trials with healthy volunteers are very risky and because they pose risks with no benefits, unethical. But how risky are such trials? Less than 1% of 11,000 healthy volunteers who participated in 394 phase I trials for new drugs experienced serious complications, according to a new meta-analysis of participants in non-cancer, phase I medication trials. In addition, none of the volunteers died or suffered persistent disabilities linked to the experimental drugs. In the largest study of its kind, researchers found only 34 (0.31%) healthy volunteers with serious adverse events, which are defined by the FDA as those that result in death; are life-threatening; require or prolong in-patient hospitalization; or cause a disability, congenital anomaly or birth defect. (…)

The investigators found that 63.7% of participants experienced a combined total of 24,643 adverse events, and the other 36.3% experienced no adverse events of any kind. Nearly a quarter (24.1%) of all adverse events were judged to be unrelated to the study drug, and the vast majority (84.6%) of adverse events were classified as mild, 14.4% as moderate, and 1% as severe. The "mild" classification means that symptoms did not interfere with usual functioning while a severe adverse event interferes significantly with a subject's basic daily functioning; for example, a broken finger. The most common adverse events were headache (12.2%), drowsiness (9.8%), diarrhea (6.9%), nausea (5.9%), dizziness/lightheadedness (5.4%), and vomiting (2%). (…)

Medie: Novartis forhindrer konkurrents kliniske forsøg
medwatch.dk 7.4.2015
Schweiziske Novartis er under anklage for at forhindre læger i at deltage i kliniske forsøg med et billigere alternativ til schweizernes øjenlægemiddel Lucentis.

Medicinalvirksomheden Novartis er angiveligt ikke meget for konkurrence for deres øjenlægemiddel Lucentis til behandling af våd aldersrelateret maculadegeneration (AMD). I hvert fald er selskabet nu under anklage for at forhindre kliniske forsøg med det billigere alternativ Avastin fra Roche.

Det skriver Biospace.com på baggrund af afsløringer i The British Medical Journal.

Avastin er godkendt til behandling af kræft, men tidlige kliniske studier har vist, at det også kan være effektivt mod AMD. Men det er åbenbart ikke faldet i god jord hos schweizerne.

Ifølge The British Medical Journal har Novartis forsøgt at få flere læger til at trække sig ud af flere kliniske forsøg med Avastin ligesom en læge angiveligt skulle være blive opfordret til at trække sig fra et klinisk forsøg med "fremtidige personlige forskningsprojekter for øje."

Novartis afviser alle anklager om "bøllemetoder".

Du kan læse hele artiklen fra Biospace.com her. (...)

(Anm: Why have UK doctors been deterred from prescribing Avastin? BMJ 2015;350:h1654 (Published 01 April 2015).)

Stort antal läkemedel dras in
dagensmedicin.se 23.1.2015
Flera läkemedel återkallas från den svenska marknaden efter att det framkommit att de inte har prövats på ett korrekt sätt.

Det europeiska läkemedelsverket, EMA, har i dag, fredag, beslutat att dra tillbaka marknadstillståndet för ett stort antal läkemedel uppger myndigheten på sin webbplats. I Sverige rör det sig om 17 läkemedel.

Skälet till att läkemedlen återkallas är en skandal där det upptäcktes att forskningsföretaget GVK Biosciences i Hyderbad i Indien inte hade utfört kliniska prövningar på ett korrekt sätt.

– För samtliga av de läkemedel som dras tillbaka finns andra läkemedel med samma aktiva substans, säger Elina Rönnemaa, utredare på Läkemedelsverket, till Dagens Medicin.

Enligt Elina Rönnemaa utgör inte de läkemedel som dras tillbaka någon risk för patienterna. (…)

Cancerstudie stoppad efter dödsfall
lakemedelsvarlden.se 7.11.2013
FDA har stoppat rekryteringen till en fas I-studie efter att en patient dog av leversvikt.

GSK stoppar fas III-studie mot Crohns

Curis cancerläkemedelskandidat CUDC-427 för patienter med avancerade och refraktära solida tumörer eller lymfom testas just nu i en fas I-studie. Den var utformad för att ta reda på maximalt tolererad dos och bestämma en optimal dos för en fas II-studie.

Men en patient, som hade metastaserad bröstcancer fick en allvarlig biverkning av behandlingen, drabbades av leversvikt och dog. Amerikanska läkemedelsmyndigheten FDA har nu delvis stoppad studien. Det innebär att inga nya patienter får rekryteras till studien tills Curis lämnat in ytterligare uppgifter och analys av de patienter som behandlas med CUDC-427 till myndigheten. Läkemedelsföretaget måste också lämna in ett förslag till ändringar.

Curis licenserar CUDC-427 från Genentech. (...)

Novartis Drug Scandal May Taint Japanese Clinical Research
pharmatimes.com 1.10.2013
A health ministry panel on Monday questioned Novartis Pharma K.K.'s use of clinical research data in promoting the sale of its blood pressure-lowering drug Diovan, saying it "could constitute misleading advertisement" following the revelation that some of the data was manipulated.

The Japanese unit of Swiss pharmaceutical company Novartis AG promoted its product, released in Japan in 2000, by saying it also works better than other competitors' drugs in reducing incidences of brain strokes or angina, according to the panel's interim report.

While the panel expressed concern that the scandal may have tainted the credibility of clinical research conducted at Japanese institutions, there appear to be many hurdles in getting to the bottom of the entire case that have not been fully disclosed. (...)

Novo sendte 14 mio. sider og 9 mio. links
medwatch.dk 11.9.2013
Medicinalbranchen oplever stærkt stigende regulatoriske krav for at få godkendt lægemidlerne, og de summer, der investeres i et lægemiddel er enorme. Her er Novo Nordisks tal.

Insulin Novo Semilente, Insulin Novo Lente og Insulin Novo Ultralente. Tre produkter, der blev lanceret af Novo Nordisk i løbet af 1950’erne, og som der blev søgt om markedsføringsregistrering af i 1952.

En ansøgning, der fyldte i alt 7 sider. Det var dengang. I nyere tid er registreringsansøgningerne mildest talt mere omfattende.

Printede man siderne i den amerikanske registreringsansøgning for Tresiba/Ryzodeg ud og stablede dem, ville de nå 1,56 km. i højden.

Således fyldte den såkaldte NDA-fil (New Drug Application) for Novo Nordisks GLP-1-analog Victoza, der i 2008 blev indsendt til det amerikanske FDA, 930.000 sider. Blot tre år senere er omfanget af registreringsansøgningen yderligere forøget markant. (...)

(Anm: Association of Bile Duct and Gallbladder Diseases With the Use of Incretin-Based Drugs in Patients With Type 2 Diabetes Mellitus. (…) Conclusions and Relevance: The use of GLP-1 analogues was associated with an increased risk of bile duct and gallbladder disease. Physicians should be aware of this potential adverse event when prescribing these drugs.JAMA Intern Med. 2016 Aug 1. [Epub ahead of print].)

Neurosearch-ansatte risikerer fire års fængsel
business.dk 17.7.2013
Neurosearch anklages for i februar 2010 at have sendt en forkert meddelse om forskningsresultater for lægemidlet Hentexil ud, hvilket fik aktien til at stige eksplosivt. (...)

Medicinalfirma tjekker alle sager
jyllands-posten.dk 12.7.2013
Medicinalfirmaet AstraZeneca vil tjekke alle sine kliniske forsøg i Danmark for eventuelle uregelmæssigheder. Firmaet har allerede undersøgt seks forskningsprojekter med overlæge Peer Grande som ansvarlig. (...)

Industrin bakom hög andel forskning
dagensmedicin.se 12.7.2013
Industrin har finansierat de flesta kliniska läkemedelsprövningar inom norsk allmänmedicin, enligt en studie.

Anja Maria Brænd på universitetet i Oslo har studerat alla kliniska läkemedelsprövningar som gjordes helt eller delvis inom allmänmedicin 1998–2007. Av totalt 196 studier hade 96 procent finansierats av läkemedelsindustrin, berättar norska Dagens Medisin.

Detta är problematiskt anser Anja Maria Brænd, som tycker att fler läkemedelsprövningar bör vara oberoende.

– Läkemedelsindustrin vill finansiera studier av nya läkemedel. Men man bör också undersöka befintliga mediciner, för att till exempel ta reda på hur de kan användas i nya typer av behandling, säger Anja Maria Brænd till Dagens Medisin.

Också mer kunskap om att kombinera mediciner behövs, liksom studier som tittar på vad som händer när en läkemedelsbehandling av en patient avslutas, anser hon.

Marit Hermansen, ordförande i Norsk förening för allmänmedicin, säger att studien bekräftar föreningens egen misstanke att läkemedelsindustrin forskar på sina egna läkemedel.

– Vad vi behöver är en allmänmedicinsk forskning där vi studerar våra egna rutiner och väcker frågor som är viktiga för oss själva, säger hon till Dagens Medisin.
Hon efterfrågar ökade anslag för att göra denna typ av forskning möjlig.

Studien har publicerats i tidskriften Trials. (...)

GSK confirms probe by Chinese authorities (GSK bekrefter kinesiske myndigheters granskning)
BMJ 2013;347:f4328 (Published 3 July 2013)
A group of senior executives at GlaxoSmithKline is at the centre of an investigation by Chinese authorities into the company’s operations in China.

Managers from each of the UK based drug firm’s three sites in Beijing, Changsha, and Shanghai are believed to be in police custody, report the official news agency Xinhua and the Hong Kong newspaper South China Morning Post.

A GSK spokeswoman confirmed that investigations were under way but declined to comment on whether its staff members were in custody. “We are aware of ongoing investigations in a number of sites but we are not actually sure what the investigation is into,” she said. “We are cooperating with the investigation and will do whatever is required but at this stage they are not giving us a lot of information on what it’s about. We don’t know if it’s connected to the whistleblower complaint.” (...)

Is GlaxoSmithKline's China probe a harbinger of more? (Er GlaxoSmithKlines Kinagranskning forløperen til noe mer?)
fiercepharma.com 2.7.2013
Are more drugmakers at risk of corruption probes in China? After GlaxoSmithKline employees were detained in an investigation of "economic crimes," industry watchers point out that the Chinese government recently reorganized its Food and Drug Administration. The healthcare system is in the midst of reform, with officials keeping an eye out for corruption.

As Bloomberg reports, it's too soon to tell whether the Glaxo ($GSK) investigation is the first in a wave of pharma probes, á la the antitrust crackdown in Europe. But in general, anti-corruption action is increasing in China, an EU Chamber of Commerce official told the news service.

"In recent months, we've seen more actions and police investigations in relation to corruption in companies in China by Chinese authorities," Ronan Diot said (as quoted by Bloomberg). "It sometimes happens that people are detained for a few hours or a few days." (...)

(Anm: Glaxo, Danone Probed as China Scrutinizes Foreign Firms (bloomberg.com 2.7.2013).)

GlaxoSmithKline fires head of its China based research arm for misrepresentation of data (GlaxoSmithKline sparker leder for sin forskning for skjev fremstilling av data)
BMJ 2013;346:f3914 (Published 14 June 2013)
British pharmaceutical giant GlaxoSmithKline (GSK) has fired the head of its China based research arm and is seeking the retraction of an article in Nature Medicine after a company investigation found evidence of misrepresentation.

GSK announced the dismissal of the paper’s coauthor, neurologist Jingwu Zhang, a senior vice president and head of R&D China in Shanghai. A second author has resigned and three others are on administrative leave, the company said.

Another author, Jian Hong of Baylor College of Medicine in Texas, was cleared of wrongdoing by the investigation.

“Regretfully, our investigation has established that certain data in the paper were indeed misrepresented,” said a GSK statement, which emphasised that the research was preclinical and did not involve patients. “We’ve shared our conclusion that the paper should be retracted and are in the process of asking all of the authors to sign a statement to that effect, according to Nature Medicine’s procedure.” (...)

GlaxoSmithKline slams brakes on trial of MS drug linked to data scandal
fiercepharma.com 13.6.2013
GlaxoSmithKline ($GSK) has stopped development of an experimental drug for multiple sclerosis after a preclinical study turned out to contain "misrepresentations" in data from its R&D labs in China.

The London-based drugmaker slammed the brakes on a Phase I study of a compound known as GSK 2618960, pending a review of questionable data from a non-drug study of a suspected mechanism in multiple sclerosis. The study involved blood samples of MS patients and the role of a protein known as IL-7 in the disease. Evidence of falsified data in the study has cost two GSK researchers their jobs and prompted the drugmaker to take steps to retract the findings of the study published in 2010 in Nature Medicine. (...)

More On The GlaxoSmithKline Shanghai Scandal
seekingalpha.com 11.6.2013
The accusations of data fabrication at GlaxoSmithKline's (GSK) China research site are quite real. That's what we get from the latest developments in the case, as reported by BioCentury, Pharmalot, and the news section at Nature Medicine. Jingwu Zang, lead author on the disputed paper and former head of the Shanghai research site, has been dismissed from the company. Other employees are on administrative leave while an investigation proceeds, and GSK has said it has begun the process of retracting the paper itself.

As for what's wrong with the paper in question, BioCentury Extra has this:

GSK said data in a paper published in January 2010 in Nature Medicine on the role of interleukin-7 (IL-7) in autoimmune disease characterized data as the results of experiments conducted with blood cells of multiple sclerosis (MS) patients "when, in fact, the data reported were either the results of experiments conducted at R&D China with normal (healthy donor) samples or cannot be documented at all, suggesting that they well may have been fabricated." (...)

GlaxoSmithKline (GSK) Probes Allegedly Fraudulent Data in Study Written by Employees
biospace.com 5.6.2013
Staying up-to-date has never been simpler. Sign up for the free GenePool newsletter today!

In the latest instance in which a global drugmaker has become embroiled in a scandal over published study results, GlaxoSmithKline is investigating whether a paper that appeared in Nature Medicine three years ago and was co-authored by more than a dozen scientists at its R&D Center in Shanghai, China, contained fabricated data. (...)

GlaxoSmithKline: No China Bribery Found
manufacturing.net 13.6.2013
BEIJING (AP) -- Drug manufacturer GlaxoSmithKline said Thursday it has investigated an accusation that its salespeople in China bribed doctors and found no evidence of wrongdoing.

The company said it conducted a four-month investigation after receiving complaints from an anonymous source. It said it found "no evidence of corruption or bribery in our China business."

GlaxoSmithKline PLC is headquartered in Britain but has a presence in the United States, which could make it liable to penalties under U.S. anti-bribery laws.

The Wall Street Journal, citing company documents, reported the complaint said GlaxoSmithKline staff in China provided doctors with speaking fees, cash payments, lavish dinners and travel in return for prescribing its products.

"We have used significant resources to thoroughly investigate each and every claim from this single, anonymous source and have found no evidence of corruption or bribery in our China business," said GlaxoSmithKline in a statement.

"GSK wants to reiterate to its patients, staff and partners in China that these allegations are false." (...)

Bioanalyst gets jail sentence for falsifying preclinical trial data
BMJ 2013;346:f2514 (18 April 2013)
A former senior bioanalyst who worked in Scotland for a US based drug discovery and development firm, Aptuit, has become the first person to be successfully prosecuted under the Good Laboratory Practice Regulations 1999 for manipulating data.

Steven Eaton, who worked for Aptuit until 2009, was found guilty at Edinburgh Sheriff Court and sentenced to three months in prison, after a prosecution brought by the Medicines and Healthcare Products Regulatory Agency (MHRA). (...)

Fängelse för forskarfusk
lakemedelsvarlden.se 18.4.2013
En brittisk forskare har fått fängelsestraff efter att ha förfalskat resultat i en studie av ett cancerläkemedel.

Det var 2009 som den brittiske forskaren förfalskade studieresultat för en läkemedelskandidat mot cancer. Anledningen till fusket var att han ville gå vidare och testa medlet på människor men hans verkliga data räckte inte till. Forskaren fabricerade då studieresultat och presenterade för sina dåvarande chefer.

Mannen, som då arbetade vid företaget Aptuit, har nu dömts till tre månaders fängelse av brittisk domstol, rapporterar BBC. Det hela uppdagades när kollegorna började titta närmre på hans dokumentation och konstaterade att allt inte stod rätt till. De avbröt då allt arbete som forskaren var involverad i vid företaget.

Fallet blev känt då han dömdes i mars under en lag som kallas Good Laboratory Practice Regulations. Han är den andra personen som hittills blivit åtalad under lagen men den första som blivit dömd.

Gerald Heddell, chef för det brittiska läkemedelsverkets inspektionsenhet, säger i ett utlåtande att han välkomnar domen och att den är en signal om att de inte tvekar om att åtala personer som på detta vis riskerar allmänhetens säkerhet.

Enligt BBC har den dömda forskaren manipulerat studieresultat sedan 2003. (...)

Scientist Steven Eaton jailed for falsifying drug test results
bbc.co.uk 17.4.2013
Eaton had been selectively reporting research data since 2003

A scientist who faked research data for experimental anti-cancer drugs has been jailed for three months for falsifying test results.

Steven Eaton, from Cambridgeshire, has become the first person in the UK to be jailed under scientific safety laws.

Eaton, 47, was working at the Edinburgh branch of US pharmaceutical firm Aptuit in 2009 when he came up with the scam.

If it had been successful, cancer patients who took the drug could have been harmed, the court was told.

Edinburgh Sheriff Court heard how Eaton had manipulated the results of an experiment so it was deemed successful when it had actually failed.(...)

Man guilty of manipulating drug tests (Mann skyldig i å manipulere legemiddeltester)
ft.com 12.3.2013
A man has been found guilty of manipulating the results of experimental medicine tests on animals to exaggerate their benefits, in the first such prosecution by British regulators.

Steven Eaton, a former employee of Aptuit, a US-based clinical research organisation, was judged at Edinbugh Sheriff’s Court for violating Good Laboratory Practice.

His actions since 2003 had falsely given the impression of successful tests, forcing a review of “many hundreds” of safety studies to ensure they had not been compromised, the Medicines and Healthcare Products Regulatory agency said. It ultimately concluded that the results did not invalidate the trials involved, from companies including AstraZeneca and Roche.

The prosecution comes at a time of growing debate over the data used in drug tests.

Mr Eaton had selectively reported figures on whether analytical methods were working properly and which assess the concentration of the drug in blood. The data manipulation ensured an experiment appeared successful when in fact it had failed.

The regulators said Aptuit had itself identified the problems through an internal audit. His actions triggered “considerable” costs and generated “significant” delays in testing medicines.

Gerald Heddell, director of inspection, enforcement and standards at the agency, said: “Mr Eaton’s actions directly impacted the validity of clinical trials and delayed a number of medicines coming to market, including one to treat depression. This conviction sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health.” (...)

Former Aptuit LLC Employee Found Guilty of Data Scam
biospace.com 13.3.2013
A former employee of the Aptuit clinical research organization was found guilty of altering pre-clinical trial data that was used to support applications to perform clinical trials, according to the UK’s Medicines and Healthcare products Regulatory Agency. The MHRA noted this was the first instance in which Good Laboratory Practice Regulations were used to pursue such a prosecution. The probe into Steven Eaton began when Aptuit identified serious irregularities in pre-clinical data and informed the agency. Dating back to 2003, he began selectively reporting used to assess whether analytical methods were working properly or to assess the concentration of the drug in blood. The data manipulation ensured an experiment was deemed successful, when it actually had failed, the MRHA notes. (...)

A Clinical Trial and Suicide Leave Many Questions: Part 5: The Case of the Mysteriously Appearing Documents
blogs.scientificamerican.com 12.3.2013
This series uses the story of Dan Markingson’s participation in a clinical trial of anti-psychotics at the University of Minnesota, his ultimate suicide while participating on the study, and subsequent events as a case study in which to explore various aspects of clinical trial conduct. In previous posts, we’ve looked at issues of “good clinical practices” and ethics: consent, investigator responsibilities, and conflicts of interest. In the last post, we examined the University’s response. Now we return to the importance of careful documentation of consent.

Since I last wrote on the lapses in good clinical practices at the University of Minnesota, involving the suicide of a clinical trial participant, Dan Markingson, more disturbing documents have come to light, provided and contextualized by Professor Carl Elliott. Hard to imagine, I know…but this single case can provide a lifetime of lessons on clinical trial conduct, oversight, and ethics. (...)

Differences in Reporting of Analyses in Internal Company Documents Versus Published Trial Reports: Comparisons in Industry-Sponsored Trials in Off-Label Uses of Gabapentin
PLoS Med 2013;10(1):e1001378
Background Details about the type of analysis (e.g., intent to treat [ITT]) and definitions (i.e., criteria for including participants in the analysis) are necessary for interpreting a clinical trial's findings. Our objective was to compare the description of types of analyses and criteria for including participants in the publication (i.e., what was reported) with descriptions in the corresponding internal company documents (i.e., what was planned and what was done). Trials were for off-label uses of gabapentin sponsored by Pfizer and Parke-Davis, and documents were obtained through litigation. (...)

Drug Trials
Why the exclusion of older people from clinical research must stop

BMJ 2012;344:e3445 (21 May)
Age bias in clinical research leads to uncertainty about risks and benefits in new treatments for older people. Geoff Watts looks at the barriers to recruitment

Exclusion of older people from clinical research, and of under-recruitment to clinical trials, is widespread.1 This problem has stark consequences, according to an expert committee of the European Medicines Agency (EMA). “The drugs we are using in older people have not been properly evaluated.”

While the paucity of clinical trials on young children is well documented and frequently discussed, the same cannot be said of a similar shortfall at the upper end of the age spectrum. In fact older people are proportionately under-represented or even absent from most drug trials. This matters because just as children are not physiologically identical to adults, neither are very elderly people equivalent to those decades their junior.

Recognising this, and mindful that the older generation (those over 80) are the fastest growing sector of the population, the EMA recently held a workshop at its headquarters in London to consider what might be done. (...)

Merck ordered to pay $321 million in criminal Vioxx probe
reuters.com 19.4.2012
(Reuters) - A Boston federal judge on Thursday sentenced Merck & Co to pay a $321 million criminal fine for improperly marketing its Vioxx painkiller a decade ago.

The U.S. drugmaker pleaded guilty in recent months to having illegally promoted Vioxx for treatment of rheumatoid arthritis before it was approved for that use in 2002. The pill, approved in 1999 as a painkiller, was withdrawn from the market in 2004 after it was linked to risk of heart attack and stroke.

Federal prosecutors in Boston said Merck illegally promoted Vioxx for rheumatoid arthritis for three years, continuing to do so after being reprimanded in September 2001 by the U.S. Food and Drug Administration. (...)

Appetite suppressant was probably responsible for 1300 deaths, study shows (Apetittdempende legemiddel var sannsynligvis skyldig i 1300 dødsfall, ifølge studie )
BMJ 2012;344:e996 (9 February)
A research study into the drug benfluorex (marketed as Mediator), which was withdrawn from the French market in 2009 because of side effects, shows that its use in France during 1976-2009 was probably responsible for around 1300 deaths and 3100 hospital admissions.

The study, published in Pharmacoepidemiology and Drug Safety, was carried out by Agnès Fournier and Mahmoud Zureik, two epidemiologists from the Institut National de la Santé et de la Recherche Medical (Inserm) (2012, doi:10.1002/pds.3213).

They warn that these figures may be underestimates. Patients who took the appetite-suppressant drug experienced valvular insufficiency.

“We have worked with available data from hospitals activity monitoring and from Social Security reimbursements,” Dr Zureik explains. “The population we have studied consisted of 303 336 patients who had taken 78 million boxes of Mediator.” About 5 million people took the drug in the 33 years it was on the market.

The results are published at a difficult time for its manufacturer Servier, because the founder of the company Jacques Servier and his collaborators are due to appear in court in Nanterre, from 14 May to 6 July, to face charges of deception.

Monsieur Servier, and several other executives from his firm, are accused of knowingly hiding the side effects of benfluorex, a fenfluramine derivative drug marketed as an adjunct in the treatment of hyperlipidaemia.

This is only one of two legal cases facing the company. In the second case, which is underway in Paris, the company faces charges of “deception” and “unintentional injuries and manslaughter.” (...)

Argentinean court upholds fines against GSK and two doctors for malpractice during vaccine trial
BMJ 2012;344:e449 (17 January)
An Argentinean court has dismissed an appeal by the drug company GlaxoSmithKline (GSK) and upheld a fine of 400 000 pesos (£61 000; €73 000; $93 000) for failing to properly monitor a trial of the multivalent pneumococcal conjugate vaccine Synflorix.

The judge has also upheld fines against two local doctors of 300 000 pesos each. Miguel Tregnaghi, the main coordinator of the trial in Argentina, was fined for failing to comply with good practice in the development of a clinical trial, and Hector Abate, the main investigator in Mendoza, one of the three regions where the study took place, was fined for administrative irregularities during patient selection and the collection of informed consent.

The penalty, the maximum that can be applied under national regulations for serious misconduct and the highest ever relating to clinical trials in the country, was imposed in 2009 by the Argentinean National Administration of Drugs, Food and Medical Technology (ANMAT) after detecting irregularities in the recruitment of a few patients to the clinical otitis media and pneumonia study (COMPAS). (...)

(Anm: Openness and honesty in gaining fully informed consent will benefit both patients and doctors BMJ 2015;350:h1784 (Published 07 April 2015).)

India’s drug trials fuel consent controversy
washingtonpost.com 2.1.2012
KHANDWA, India — Two months after he lost his wife to Alzheimer’s disease, 80-year-old Sharad Geete made a shocking discovery. The free drugs his wife, Sheela, had been receiving for two years before she died were part of a clinical trial.

“The doctor told us that the medicines will be given free and that they were going to be launched soon by a foreign company. Not once did he say it was an experiment or a trial. If I knew, would I have taken the risk?” asked Geete, sitting in his home in Khandwa, a small town in the central Indian state of Madhya Pradesh.

Since India eased guidelines for conducting drug trials in 2005, the number of Indians participating has shot up to 150,000 from close to zero, as international drug companies take advantage of lower costs here. But questions about the consent process have fueled fears that many Indians are entering the trials without knowing the risks.

A Madhya Pradesh state government probe found that six doctors had violated ethical standards in gaining patients’ consent for participation in drug trials and did not compensate those who suffered adverse side effects in 76 drug trials on 3,300 patients since 2006, according to results released last June.

In the wake of the recent controversies, the Indian Council for Medical Research invited public feedback on draft guidelines about compensation for injuries that occur during clinical research. (...)

GSK lab fined over vaccine tests that killed 14 babies
buenosairesherald.com nytimes.com 4.1.2012
GlaxoSmithKline Argentina Laboratories company was fined 400,000 pesos by Judge Marcelo Aguinsky following a report issued by the National Administration of Medicine, Food and Technology (ANMAT in Spanish) for the killing of 14 babies during illegal lab vaccine trials conducted between 2007 and 2008.

Likewise, two doctors -Héctor Abate, and Miguel Tregnaghi- were fined with 300,000 pesos each for irregularities during the studies.

The charges included experimenting with human beings, falsifying parental authorizations so babies could participate in vaccine-trials conducted by the laboratory from 2007 to 2008.

Since 2007, 15,000 children under the age of one from Mendoza, San Juan and Santiago del Estero have been included in the research protocol, a statement of what the study is trying to achieve. Babies were recruited from poor families that attended to public hospitals.

A total of 7 babies died in Santiago del Estero; 5 in Mendoza; and 2 in San Juan. (...)

GlaxoSmithKline to appeal fines over paperwork in Argentine pneumonia vaccine study of babies
washingtonpost.com 3.1.2012
BUENOS AIRES, Argentina — GlaxoSmithKline said Tuesday it will appeal a fine in Argentina involving its development of a vaccine against pneumonia and earaches in small children.

The world’s second-largest drugmaker was fined $93,000 for protocol problems involving the company’s recruitment of children under 5 for clinical trials in several Argentine provinces.

Judge Marcelo Aguinsky found the company responsible for “irregularities” in the recruitment of young children.

The investigative judge also fined two investigators nearly $70,000 each because consent forms were signed by illiterate parents or people who didn’t have custody, according to a source in Aguinsky’s office, who spoke on condition of anonymity because the ruling is being challenged.

“GlaxoSmithKline respects the justice system, but would like to express its disagreement with the fine against the laboratory and investigators who participated in the clinical studies,” the company said Tuesday. (...)

Professor skjelt ut av lege fra Algeta
dn.no 3.11.2011
Strid om medisinresultatene til børsfavoritten Algeta.

Etter svært oppløftende rapporter om resultatene av kreftmedisinen Alpharadin, har Algeta-aksjen steget 36,7 prosent hittil i år og nesten 1.100 prosent de siste tre årene, til en markedsverdi på 7,68 milliarder kroner.

Det har gjort Algeta-ledelsen meget velstående.

Det er imidlertid flere tvilere i familjøet, skriver Finansavisen.

Professor i onkologi (kreft) Inger D. Fosså ved Oslo universitetssykehus Radiumhospitalet, deltok med 30 pasienter i en blindtest med Alpharadin, og fant ingen effekt hos disse. I ettertid viste det seg at 17 av pasientene fikk Alpharadin.

Første gang hun gikk offentlig ut og fortalte at hun ikke hadde funnet noen effekt av medisinen, ble hun ifølge Finansavisen ringt opp av en lege fra Algeta som skal ha skjelt henne ut.

- Jeg nektet
Igår ble hun kontaktet av et tysk firma som ba henne revurdere bivirkningenes relasjon til behandlingen på oppdrag fra Bayer.

-Jeg nektet å gjøre dette. Jeg har aldri før opplevd at et legemiddelfirma opptrer slik, sier Fosså til avisen.

Dr. med Erlend Hem mener det er umulig å si om Algetas medisin fungerer.

Han sier man ikke har sett Algetas resultater, bare det Algeta sier at er deres resultater. Han mener Algeta burde lagt frem resultatene på en konferanse, samtidig som resultatene ble publisert i et vitenskapelig tidsskrift slik at fageksperter ville kunnet kommet med innvendinger.

Algeta mener det ikke finnes noen tvil om at deres medisin Alpharadin fungerer.

Les også: Kreftmedisin fra Algeta bedre enn ventet (...)

– USAs syfiliseksperiment i Guatemala var umenneskelig
nrk.no 30.8.2011
USAs president har personlig beklaget et makabert syfiliseksperiment USA utførte i 1940-åren overfor Guatemalas nåværende myndigheter.

Minst 83 personer døde som menneskelige forsøkskaniner i et makabert forskningsprosjekt USA utførte i Guatemala i 1940-årene, fastslår en Obama-oppnevnt granskingskommisjon.

– Forskerne må ha visst at de brøt etiske standarder da de med overlegg smittet guatemalanske fanger og psykiatriske pasienter med syfilis, er kommisjonens soleklare hovedfunn.

Mer enn 1.300 guatemalanere ble i det statsstøttede eksperimentet mellom 1946 og 1948 eksponert for den seksuelt overførbare sykdommen syfilis. Rundt 700 av dem ble smittet, viser granskernes undersøkelser.

– I den gruppen mener vi å ha avdekket at 83 døde, sa kommisjonsmedlem Stephen Hauser mandag. (...)

Dårlig beskyttet
Forskningen på førtitallet skjedde med godkjenning fra amerikanske helsemyndigheter, og var ment å øke kunnskapen om antibiotikamedisinen penicillin.

Etter at det kontroversielle eksperimentet ble avdekket i fjor høst, gikk dagens helsemyndigheter i USA ut og avviste at noe lignende kunne ha skjedd i dag. Men eksperter på bioetikk er mindre overbevist. Spesielt er det grunn til å se på reglene for private forskningsprosjekter som reiser til utlandet for å foreta kliniske studier, sier professor i bioetikk på Universitetet i Minnesota, Mary Faith Marshall.

Deltakere i medisinsk forskning skal gi såkalt informert samtykke, men mange eksperter mener regelverket gir liten grad av kontroll med hvordan dette praktiseres i områder med mange analfabeter, mye korrupsjon og fattigdom. (...)

Pfizer settles with victims of Nigerian drug trial
BMJ 2011; 343:d5268 (16 August)
The drug company Pfizer has paid out $175 000 (£107 000; €120 000) to each of four families whose children died during a study of an experimental antibiotic in Kano, Nigeria. But the settlement has been strongly criticised by the families involved and by a leading ethicist in the United States, where Pfizer has its headquarters.

The study was conducted during a deadly outbreak of meningitis in 1996, when some 200 children were enrolled in the study. Half were given Pfizer’s experimental antibiotic, trovafloxacin (which it markets as Trovan), and half were given ceftriaxone. Five children died in the trovafloxacin arm and six in the ceftriaxone arm. Pfizer has not reported on the outcomes of 10 of the children.

The families said that Pfizer failed to tell them that their children were being enrolled in an experimental drug trial and that free, effective treatment was available from the charity Médecins Sans Frontières at the same hospital.

The settlements come from a $35m fund to compensate the families of children in the study. Pfizer has agreed to pay another $30m to support healthcare initiatives in Kano and $10m in legal costs.

In 2007 Pfizer acknowledged that it had given some of the children just one third of the recommended dose of the comparator antibiotic (ceftriaxone) because, the company said, the shots were “too painful” and made it too hard for the children to walk (BMJ 2007;334:1181, doi:10.1136/bmj.39237.658171.DB).

Trovafloxacin was later banned in Europe, and in 1999 the US drug regulator the Food and Drug Administration severely restricted its use, issuing a warning that the drug could lead to serious liver damage and death. (...)

Crossing the Line: The Trial of GlaxoSmithKline Lawyer Lauren Stevens
law.com 23.6.2011
When the U.S. Department of Justice charged former in-house lawyer Lauren Stevens with six felonies, it aimed to send a clear message that no one should lie to federal investigators—including lawyers. But the short and bitter trial that followed backfired. In the end it conveyed a message to both in-house counsel and prosecutors about the dangers of overzealousness.

On May 10, in a move that was as sudden as it was dramatic, a federal district court judge in midtrial acquitted the former in-house counsel at GlaxoSmithKline of all six counts. While Stevens and her lawyers celebrated with champagne, sources say the stunned prosecutors privately complained that the jury would have found Stevens guilty had the judge let the trial continue. (...)

New FDA Regulation to Improve Safety Reporting in Clinical Trials (Ny FDA-regulering for å forbedre sikkerhetsrapportering i kliniske forsøk)
NEJM 2011 (June 8)
As part of an initiative designed to modernize the clinical trial enterprise, the Food and Drug Administration (FDA) recently published a regulation establishing a new safety-reporting paradigm for drugs being studied under investigational new drug applications (INDs).1 This rule — published last September and effective as of March 28, 2011 — is one in a series of steps the FDA is taking to enhance the protection of human subjects and improve trial conduct by streamlining the regulatory procedures for clinical trials. (...)

Drug firms go online to test and sell medicines
reuters.com 8.6.2011
(Reuters) - Prompted by the soaring cost of developing and marketing their medicines, drug companies are embracing the Internet in a bid to drive down costs.
The hope is that digital tools will not only make them more efficient, but also smarter and nimbler.

Pfizer, the world's biggest drugmaker, is pushing the envelope on clinical trials by conducting the first ever "virtual" study of a medicine, in which patients will be able to participate by using home computers and smartphones.

At the same time, several large companies are changing the way they communicate and market their medicines to doctors by establishing new online services to answer product queries and let physicians order free samples.

The moves come as the cost of drug research continues to spiral upwards and companies face a wave of patent expiries on some of their biggest selling products, leading to an unprecedented round of cost-cutting across the industry, with big job cuts in both marketing and research. (...)

Inadequate reporting of research ethics review and informed consent in cluster randomised trials: review of random sample of published trials
BMJ 2011; 342:d2496 (11 May)
Objectives To investigate the extent to which authors of cluster randomised trials adhered to two basic requirements of the World Medical Association’s Declaration of Helsinki and the International Committee of Medical Journal Editors’ uniform requirements for manuscripts (namely, reporting of research ethics review and informed consent), to determine whether the adequacy of reporting has improved over time, and to identify characteristics of cluster randomised trials associated with reporting of ethics practices. (...)

Conclusions Reporting of research ethics protections in cluster randomised trials is inadequate. In addition to research ethics approval, authors should report whether informed consent was sought, from whom consent was sought, and what consent was for. (...)

Head to head comparisons are missing from half of new drug approvals
BMJ 2011; 342:d2841 (11 May)
All you need to read in the other general journals

JAMA2011;305:1786-9 [Abstract/Full text]
Doctors prescribing a new drug need to know how it compares with established alternatives. Regulators approving new drugs for market don’t always insist on head to head trials, however, so comparative effectiveness data can be hard to find in the crucial few years after the launch of a new drug. Preapproval documentation submitted to regulators is a potential source of information, although it was patchy in one recent study from the US.

Researchers analysed packages of documents submitted to the Food and Drug Administration for new drug approvals between 2000 and 2010. Just over half the packages (100/197) contained one or more studies that compared the new drug with an active alternative. The regulator’s decision was based on comparative efficacy data for just 59 out of 197 drugs.

So some data are available, some of the time. The researchers weren’t able to say whether the head to head studies found on the FDA’s website were good enough to be useful to doctors, other prescribers, or decision makers in charge of formularies. But they do think the source has potential and should be more accessible and easier to use. They would also like to see more comparative studies before drugs are approved. The findings of this US analysis are broadly in line with a study of approval decisions made by the European regulator between 1999 and 2005. (...)

Special report: Big Pharma's global guinea pigs
reuters.com 6.5.2011
(Reuters) - The Polish port city of Gdansk is famous for its shipyards. Hungary's fifth largest city, Pecs, is known for its ancient architecture and brewery. Neither is particularly renowned for medicine. Yet when AstraZeneca Plc tested its big new drug hope Brilinta on heart attack patients in a major clinical study, it was hospitals in these places that enrolled some of the highest number of patients anywhere in the world. (...)

"The motivation to involve lots of patients is very high in Eastern European countries and also in Asia," says Dr. Ivan Horvath, head of interventional cardiology at the University of Pecs. "There are three factors driving this. Our patients get access to a new drug, which is free during the trial. It is also very important for scientific reasons. And we get paid." (...)

In the United States, the widespread "off-shoring" of research was highlighted in a report last year by the inspector general of the Department of Health and Human Services, which revealed just how reliant the country has become on foreign testing. In 2008, a total of 78 percent of all subjects participating in trials to support drug applications submitted to the Food and Drug Administration (FDA) were enrolled at foreign sites -- and as more experimental medicines move through the pipeline the numbers are set to increase further. (...)

Making raw data more widely available (Å gjøre rådata mer alminnelig tilgjengelig)
BMJ 2011; 342:d2323 (4 May)
New initiative by the Wellcome Trust sets out some guiding principles

Medical investigators routinely refuse to share data from medical studies, seeming to regard such data as private property rather than a public resource for the benefit of medical science and future generations of patients. One survey found that 75% of pharmaceutical researchers were opposed in principle to making raw data available.1 Two studies have found that only a minority of researchers (10% and 25%) share data when publishing in journals with explicit policies that raw data must be made available.2 3 Even in genomics research, where the principle that microarray data should be deposited in a publicly accessible database is widely accepted, many published studies do not have an associated data set publicly available.4 5

The benefits of sharing raw data from medical studies have been widely discussed.6 7 8 9 Data sharing ensures reproducibility, allows testing of secondary hypotheses, facilitates development of new statistical methods, provides a resource for teaching, aids design of new studies, simplifies data acquisition for meta-analysis, and helps prevent fraud and selective reporting. (...)

Stan Kutcher involved in controversial drug test
thecoast.ca 28.4.2011
Lberal candidate for Halifax co-authored problematic Paxil study

Stan Kutcher, the Liberal candidate for Halifax in Monday’s federal election, is running on his expertise as a doctor.

“I have a lot of experience in the health field,” says Kutcher, “in multiple areas: as a clinician, as a researcher, as associate dean of our medical school and in my work globally in my work with the World Health Organization, as someone who has worked to establish a number of national health institutions.”

But Kutcher’s experience as a clinician and researcher includes his involvement in a controversial drug test known as the Paxil 329 study, which was the subject of multiple lawsuits and explosive allegations of wrongdoing by researchers, and which ultimately changed the way medical research is conducted.

That study started in 1992, when Martin Keller, then the chair of the Psychiatry department at Brown University, proposed to the drug company SmithKline Beechman a study of the use of Paxil for the treatment of adolescent depression. In 2000, SmithKline Beechman merged with Glaxo Wellcome to become GlaxoSmithKline.

The drug trials took place between 1994 and 1997 at 12 research centres across North America, including the Dalhousie Medical School, where Kutcher oversaw the trials. It was a typical “double blind” study, with half the participants taking Paxil, and half taking a placebo. The results were published in 2001, with Kutcher as co-author.

But as documents later made public through the lawsuits demonstrate, the initial outcome measures in the study showed that there was no difference in therapeutic benefits between Paxil and the placebo, but those measures were changed to give Paxil a more favourable result.

“They essentially distorted the outcome measures, and essentially lied,” says Alison Bass, a former science reporter with the Boston *Globe* who broke the story and went on to write *Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial*, which examines the Paxil 329 study. “They also omitted information about adolescents who became suicidal on Paxil and withdrew from the study. And they miscoded those teenagers---they said they were non-compliant when in fact they had been withdrawn from the study because they became suicidal.”

Only in 2003, when a secretary at Brown leaked information to Bass, did the problems with the study became public. Afterwards, New York state attorney general Eliot Spitzer sued GlaxoSmithKline for fraud; that suit was settled out of court, but together with separate suits filed in Canada and California, hundreds of internal GSK documents were released. In Britain, the Committee on the Safety of Medicine found that the incidence of suicidal thoughts in the Paxil group was double that of the placebo group. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Withdrawal of clinical trials policy by Canadian research institute is a “lost opportunity for increased transparency”
BMJ 2011; 342:d2570 (21 April)
Canadian researchers and academics are puzzled by the Canadian Institute for Health Research’s decision to withdraw its policy on clinical trial registration and results just three months after posting it on its website.

The institute has declined to comment on the decision. A statement on its website says that its policy has been “superseded” by a more general guidance document on the ethics of research involving humans that was prepared for, and approved by, Canada’s three major public funding agencies.

“The CIHR [Canadian Institute for Health Research] policy certainly was leading the drive towards increasing transparency,” said An-Wen Chan, a scientist with the Women’s College Research Institute in Toronto and co-author of the Ottawa Statement on Principles and Implementation of Clinical Trial Registration and Results Reporting (BMJ 2005;330:956-8; doi:10.1136/bmj.330.7497.956). (...)

Consultant is suspended for inventing data for drug trial (Konsulent er suspendert for å dikte opp data i legemiddelforsøk)
BMJ 2011; 342:d2261 (7 April)
A consultant community physician in north London has been suspended from practice for 12 months for research fraud after inventing patients for a clinical trial.
Devasenan Devendra, 41, lied repeatedly to the drug company Novartis after claiming to have recruited 69 patients for a trial comparing drugs for Muslims with diabetes who fast during Ramadan. The actual number was six.

The General Medical Council fitness to practise panel said suspension was necessary to mark the “profound unacceptability” of Dr Devendra’s conduct, which “undermines the trust that both the public and the professional have in medicine as a science.”

But the panel decided not to strike him off the medical register after hearing that he had an “exemplary” past record, did not benefit financially, and had started the research with the best of intentions. His dishonesty arose after he encountered unexpected difficulties, including losing funding for two clinical assistants and being unable to locate patients involved in earlier research he had conducted on the same subject. (...)

EU-gemensam förteckning över kliniska läkemedelsprövningar
lakemedelsverket.se 22.3.2011
Idag tillgängliggörs ett gemensamt europeiskt register med information om kliniska prövningar, vilket innebär att information om alla godkända läkemedelsstudier i EU samt Island, Norge och Liechtenstein finns tillgänglig från en och samma källa.

En EU-gemensam förteckning (www.clinicaltrialsregister.eu) över kliniska läkemedelsprövningar offentliggörs idag av European Medicines Agency (EMA). Genom denna förteckning ges allmänheten information om godkända läkemedelsstudier i EUs 27 medlemsländer, samt Island, Norge och Liechtenstein. (...)

Drug trial secrecy leaves us dependent on blind faith (Hemmelighold av legemiddelforsøk gjør oss avhengig av blind tiltro)
guardian.co.uk 5.3.2011
The revolving door between regulators and companies is less important than the European Medicines Agency's lack of transparency

In December 2010 Thomas Lonngren stepped down as the executive director of the European Medicines Agency, which regulates the pharmaceutical industry. On the 28th of that month, he sent a letter telling the management board that he was going to start working as a private consultant to the industry on 1 January.

Some places have clear regulations on this kind of thing. In the US you have to wait a year after leaving the department of defence before you can work for a defence contractor.

But after 10 days, Pat Mahony, the EMA's chairman, wrote back saying the plans were fine. He did not impose any restrictions, nor did he ask for any further information on what kind of work Lonngren intended to do. Lonngren had said there would be no conflict of interest, and that was enough. (...)

Medical Research Fraud Risks Millions of Patients' Lives in Europe
healthland.time.com 7.3.2011
(...) The doctor in question, Joachim Boldt, may have forged up to 90 studies on the safety and effectiveness of drugs known as colloids, which are used to boost blood volume in patients undergoing surgery. Boldt, 57, was the chief anesthesiologist at Ludwigshafen Hospital in Rhineland and the leading advocate of colloids. His studies were published in respected British medical journals and led to a wider application of the drugs, even though they had been shown in previous studies to be more dangerous than similar, cheaper drugs. (...)

Officials first became suspicious of Boldt's findings when readers of an article published in the U.S. journal Anesthesia and Analgesia noticed that the patterns of his data were "too perfect to be believed," reported the U.K.'s Daily Telegraph.

Medical guidelines regarding the use of colloids, which were followed by a number of British medical groups, were withdrawn for re-evaluation after it was revealed that four crucial studies on which the recommendations were based would be retracted. "The profession I represent does not want to be associated with potentially fraudulent research," John MacFie, president of the Association of Surgeons, told the Daily Telegraph, urging other doctors to stop using colloids.

German medical authorities are reviewing 92 of Boldt's publications. Meanwhile, allegations that the doctor forged signatures of co-authors on his studies, tested drugs on patients without their consent and claimed payments for operations he had never performed are the subject of a criminal investigation. (More on Time.com: Bruesewitz v. Wyeth: What the Supreme Court Decision Means for Vaccines) (...)

Postmarketing studies of drug safety
BMJ 2011; 342:d342 (8 February)
A European initiative could help bring more transparency and rigour to pharmacoepidemiology

In the early days of randomised clinical trials, their results could be manipulated in several ways—protocols could be altered in light of early findings, sponsors could exert undue influence over what could be published, and some “unfavourable” results could be suppressed entirely. In the United States, the creation of the government clinical trials website (www.clinicaltrials.gov) greatly contributed to minimising these threats to honest science.1 But requiring similar consistency, rigour, and transparency has been more difficult with observational studies, because any person or company with modest resources can purchase a large database of health insurance claims and perform a variety of epidemiological analyses with little or no accountability for the transparency, rigour, or visibility of such work. (...)

The Seroquel Scandal: A Minnesota Psychiatrist's Ethical Lapses Are Suspected
healthland.time.com 3.2.2011

In 2003, Dan Markingson, 26, was enrolled in a clinical trial at the University of Minnesota aimed at comparing several drugs to treat schizophrenia. Despite the explicit demands of his mother, Mary Weiss, to pull him out of the trial, investigators demurred. Less than six months later, Markingson committed suicide in a gruesome manner — nearly decapitating himself with a boxcutter.

Weiss sued the university; Markingson's doctor, Stephen Olson; drug maker AstraZeneca, which designed and funded the trial; and Dr. Charles Schulz, chair of psychiatry at University of Minnesota and, with Olson, a co-investigator of the study. Weiss' suit never made it to trial; a district court judge dismissed parts of it in 2008. Weiss settled with Olson for $75,000, which didn't even cover her legal fees. (More on Time.com: Investigation Shows Drug Companies Pay Bad Doctors Big Bucks to Consult) (...)

FDA issues electronic trial data guidance to support accuracy
outsourcing-pharma.com17.1.2011
Related topics: Clinical evolution, Clinical Development, Data management, Phase I-II, Phase III-IV, Regulatory affairs

The FDA has issued guidance on electronic data in clinical trials to help eliminate duplication, reduce transcription errors and promote real-time entry.

Increased computer use in clinical trials creates problems because data can be easily copied, transferred, changed or deleted without obvious evidence. To help ensure accurate, original and attributable data is available for clinical review and site inspection guidance has been issued .

The US Food and Drug Administration (FDA) draft guidance breaks handling electronic clinical trial data down into three phases: entry; review; and processing and transmission. An FDA chart showing how data might flow between the three phases is pictured below. (...)

The need for publishing the silent evidence from negative trials
Acta Psychiatrica Scandinavica 2011;123(2):91–94 ( February)
Mankind history is written by winners. Similarly, the history of psychopharmacology is written by winning drugs. And yet, there is little we can learn from victories and much to be learnt from failure. Hence, the problem of publication bias, where positive studies are considered by editors – and, probably, by many scientific readers – as particularly appealing whilst negative studies are seen as dull and irrelevant, has to be considered not only from a legal perspective but also from an academic one. Nowadays, publication bias constitutes a solid barrier not only to our pharmacological practice but, specially, to clinical trials design improvement. (...)

Drug companies play an outstanding role within the biomedical research field, usually performing neat and highly controlled research. The proportion of most frequently cited articles funded by industry increases year by year (3), and we all have to acknowledge the role of drug companies as one of the main engines allowing biomedical research to improve.

However, several authors have described a strong relationship between publication bias and source of funding of the study. Allegedly, pharmaceutical companies-funded research would be more likely not to see the light of day in the event of negative results (4, 5) and so industry-sponsored trials would be more likely to report favourable outcomes (6, 7). Perhaps, one of the most known cases of publication bias within psychiatry is the one regarding lamotrigine use in bipolar disorder. As pointed out by Ghaemi and colleagues (8), including both negative and positive studies – something that, as stressed by the author, ‘was not a voluntary act but rather because of legal judgment brought by the state of New York after a lawsuit about paroxetine use in children’– changed the positioning of lamotrigine within the bipolar field. (...)

(Anm: Skiftet fra akademiske til kommersielle legemiddelnettverk (CRO - Kontraktsforskningsorganisasjoner) (mintankesmie.no).)

Fransk läkemedelsskandal
Läkartidningen 2011;108(3):75 (17.1.2011)
En ny läkemedelsskandal rör nu upp höga vågor i Frankrike. Benfluorex kan ha dödat tusentals personer, och borde ha förbjudits redan för tio år sedan. Historien visar på stora brister i den franska läkemedelskontrollen, enligt en ny rapport.

Mellan 500 och 2 000 franska invånare kan ha avlidit efter att ha tagit benfluorex, som har saluförts under namnet Médiator i Frankrike.

Dödsorsaken ska i första hand ha varit kardiell valvulopati, och siffrorna kommer från det franska läkemedelsverket Afssaps. (...)

Mentally Ill Excluded in Chantix Clinical Trials
lawyersandsettlements.com 26.12.2010
Washington, DC: The reality that Chantix was fast-tracked for approval by the US Food and Drug Administration (FDA), together with the FDA's failure to require Chantix manufacturer Pfizer to include depressed and mentally-ill patients in the product's clinical trials, has left experts and advocates baffled, according to fairwarning.org in a story appearing in the December 19 issue of the Houston Chronicle. The risk for Chantix suicide as a major adverse reaction, say Chantix critics, is hardly surprising.

Fairwarning.org reminds us that Chantix appeared to be so promising from the outset that the FDA, for reasons unexplained, gave Pfizer the green light for an accelerated approval without initial requirement for follow-up studies on mentally-ill patients. The absence of depressed or mentally-ill patients from clinical trials is also a curiosity, given that most people who continue to smoke tend to suffer from depression, anxiety, or some other form of emotional instability or mental illness. (...)

(Anm: FDA warn Chantix could affect patients' alcohol tolerance (medicalnewstoday.com 10.3.2015).)

GSK lawyer is indicted on charges of obstructing FDA proceeding (GSK-advokat er siktet etter anklager om å forhindre FDA-prosedyre)
BMJ 2010; 341:c6570 (17 November)
The US Department of Justice has charged Lauren Stevens, a retired GlaxoSmithKline (GSK) lawyer, in relation to alleged off-label marketing of a drug. She faces one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and four counts of making false statements to the Food and Drug Administration.

Although drug companies have in the past been charged with off-label marketing of drugs, and several have paid large fines, it is thought that this is the first time an individual has been charged. GSK has not been charged and is not identified in the indictment.

The charges relate to the alleged off-label marketing of the antidepressant bupropion (marketed by GSK as Wellbutrin) for weight loss, and each carries a possible penalty of five to 20 years in prison. (...)

Psychiatrist pleads guilty to faking data in Paxil studies (Psykiater erklærer seg skyldig i forfalskning av data i Seroxat-studier (Paxil-studier))
paxilbirthdefectslawyers.com 16.11.2010
In August 2010, 58-year old psychiatrist involved in two clinical trials evaluating the antidepressant drug Paxil for children and adolescents pled guilty to 15 counts of conducting fraudulent trials. The Food and Drug Administration alleged that Dr. Maria Carmen Palazzo’s studies included children who did not have the diagnosis being studied. Further, Dr. Palazzo reported symptoms she knew the study subjects did not demonstrate. GlaxoSmithKline (GSK), the manufacturer of Paxil, gave Dr. Palazzo $5,000 for every child she enrolled.

The use of Paxil on children became extremely controversial after it emerged that GSK failed to publish a risk of suicidal tendencies associated with its drug Paxil. It is alleged that GSK knew about the Paxil-suicide connection for approximately 15 years. The drug now carries a black-box warning for suicide in children.

Dr. Palazzo was sentenced to 13 months in prison for conducting fraudulent clinical trials. That term will be served concurrently with her 87-month prison term for health care fraud at her New Orleans clinic. (...)

US drug company executives could face criminal charges for off-label promotion
BMJ 2010; 341:c5808 (19 October)
Executives of drug companies may face charges in a criminal court if their companies promote the off-label use of drugs, an attorney for the US Food and Drug Administration has said.

The agency’s deputy chief for litigation, Eric Blumberg, speaking at a conference in Washington, DC, said, “It’s clear we’re not getting the job done with large, monetary settlements. Unless the government shows more resolve to criminally charge individuals at all levels in the company, we cannot expect to make progress in deterring off-label promotion.”

Blumberg cited Pfizer, the world’s largest drug manufacturer, for violating regulations forbidding the promotion of drugs for conditions other than those approved by the FDA. (...)

Antidepressant Found 'Ineffective and Potentially Harmful'
theepochtimes.com 1.11.2010
CLOSET SKELETONS: Of all the drug trials that have been done, how many more skeletons in the closet are there?

If we wanted to find out if a drug or another treatment were any good, we would have to conduct some randomized controlled trials. This means individuals are randomly assigned to the drug being tested, a placebo, or another drug.

Neither the researchers nor the study participants know what’s being taken. Symptoms or other markers of health are monitored as well as side effects. After a period of time, the code is cracked, and we can learn who was taking what. (...)

Why are drug trials in Alzheimer's disease failing? (Hvorfor feiler legemiddelforsøk på Alheimers sykdom?)
Lancet 2010; 376(9751):1466 (30 October)
You suggest several reasons why trials in Alzheimer's disease are failing (Aug 28, p 658),1 but you do not consider an obvious one: that the hypothesis on which most Alzheimer's trials are based might not be valid.

If a scientist does several experiments on the basis of a hypothesis and they all fail, he will abandon the hypothesis. Why are we so reluctant to do this in medicine? The dominant hypothesis in the field is the amyloid hypothesis and almost all trials of potential disease-modifying drugs are based on manipulation of β amyloid. In the recently abandoned semagacestat trial,2 some patients on the drug got worse—ie, the drug, which was designed to inhibit formation of β amyloid, seemed to speed up cognitive decline. One interpretation is that the formation of β amyloid might be the brain's protective mechanism against the disease process. But this view is regarded as pure heresy. Is that because so much research funding and such large drug development budgets are at stake? (...)

Bolag får betala miljarder
dagensmedicin.se 29.10.2010
Läkemedelsbolaget Glaxo Smithkline måste betala motsvarande 6 miljarder kronor efter att föroreningsproblem och fusk med mängden aktiv substans i läkemedel har avslöjats i företagets fabrik.

I veckan avgjordes en åtta år lång rättsprocess i USA. Glaxo Smithkline ska nu betala den amerikanska staten 750 miljoner dollar.

Dessutom får Cheryl Eckard, en före detta anställd, 96 miljoner dollar som belöning för att hon avslöjade missförhållandena i företagets läkemedelsproduktion. Det skriver tidningen Guardian på nätet. (...)

Glaxo lawsuit shows hypocrisy of drug industry
By Editorial Board
sunjournal.com 29.10.2010
(...) The settlement shows two things:

First, that the drug makers themselves manufacture overseas and, at least in the GSK case, have lax standards.

Second, that the U.S. government needs an independent way to monitor the quality and efficacy of drugs made either here or abroad. We shouldn't have to rely on whistleblowers for our safety.

Having an independent agency would also open the door to re-importing brand-name drugs from overseas.

As we have long argued, it is simply nuts that Americans pay to educate scientists who develop drugs, we fund much of the research that leads to drug innovations, and then we pay the highest drug prices in the world. (...)

When we wonder why our medical costs are the highest on earth, this is one of the major reasons — this legalized gouging of American consumers.

If we don't allow price controls like other countries, at least allow the federal government to negotiate for better rates and allow the re-importation of medicines from low-cost countries.

If we are serious about controlling out-of-control medical expenses, this is the place to start. (...)

Drug companies are accused of using unsuitable doctors to promote their products (Legemiddelfirmaer anklaget for å bruke uegnede leger til å promotere sine produkter)
BMJ 2010; 341:c6026 (26 October)
Hundreds of doctors who have been disciplined for ethical breaches or had their medical licences revoked are on drug companies’ payrolls as speakers and consultants, an investigative report released on 18 October says.

The wide ranging investigation took months and was the product of a collaboration between the investigative news organisation ProPublica, a non-profit group based in New York, and five other news outlets: National Public Radio, the Chicago Tribune, the Boston Globe, Consumer Reports, and the US Public Broadcasting Service’s Nightly Business Report.

Doctors cited in the report include a pain physician who had performed “unnecessary” nerve tests on 20 patients and an anaesthetist who had admitted giving young female patients rectal and vaginal exams without documenting why.

The reporters created a searchable database of payments to doctors since 2009. The database includes $258m (£163m; €185m) in payments to 17 700 individuals by seven drug companies: Pfizer, GlaxoSmithKline, Merck & Co, Johnson & Johnson, Eli Lilly, AstraZeneca, and Cephalon. The seven companies collectively comprise a 36% share of the $300bn drug market in the United States. (...)

NM to get more than $194,000 in drug settlement
sunjournal.com 30.10.2010
New Mexico Attorney General Gary King says pharmaceutical manufacturer GlaxoSmithKline PLC will reimburse more than $194,000 to New Mexico's Medicaid program to settle allegations of selling adulterated medications. (...)

Glaxo to Pay $750 Million in Pact; Whistleblower Due Big Payment
online.wsj.com 27.10.2010
GlaxoSmithKline PLC agreed to pay $750 million and plead guilty to a criminal charge to settle a U.S. government investigation of manufacturing deficiencies at its former plant in Puerto Rico.

The probe was sparked by a suit filed by a former employee who is now entitled to $96 million from the settlement under a federal whistleblower law, according to the Justice Department.

Glaxo previously disclosed in July it had reached an agreement in principle to settle the probe, which stemmed from the manufacture of defective pills including the Paxil antidepressant at Glaxo's plant in Cidra, Puerto Rico, between 2001 and (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Glaxo Pays $750 Million Fine for Tainted Products (Glaxo betaler 750 millioner dollar i bot for infiserte produkter)
nytimes.com 26.10.2010
The GlaxoSmithKline offices in London. GlaxoSmithKline sold 20 drugs with questionable safety that were made at a huge plant in Puerto Rico that for years was rife with contamination.

GlaxoSmithKline, the British drug giant, has agreed to pay $750 million to settle criminal and civil complaints that the company for years knowingly sold contaminated baby ointment and an ineffective antidepressant — the latest in a growing number of whistle-blower lawsuits that drug makers have settled with multimillion dollar fines.

Altogether, GlaxoSmithKline sold 20 drugs with questionable safety that were made at a huge plant in Puerto Rico that for years was rife with contamination. Cheryl Eckard, the company’s quality manager, asserts in her whistle-blower suit that she warned Glaxo of the problems but the company fired her instead of addressing the issues. Among the drugs affected were Avandia, Bactroban, Coreg, Paxil and Tagamet. No patients are known to have been sickened by the quality problems although such cases would be difficult to trace. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

Drug Firms Face Bribery Probe (Legemiddelfirmaer granskes for bestikkelser)
online.wsj.com 5.10.2010
Federal investigators are looking at ways that drug makers could be paying bribes overseas to boost sales and speed approvals, according to letters sent to the companies and people close to the matter.

Big companies—including Merck & Co., AstraZeneca PLC, Bristol-Myers Squibb Co. and GlaxoSmithKline PLC—in recent months have disclosed they are being investigated for possible violations of a 1977 law that makes it illegal for companies whose stock is traded in the U.S. to bribe government officials in other countries to get business.

The companies said they are cooperating with the government, with several adding that the investigation is industry-wide and broader than their companies specifically. Many said they have policies meant to ensure compliance with the Foreign Corrupt Practices Act.

So far, none of the companies has been accused of wrongdoing, and the investigation ultimately may not result in charges. (...)

Neurocrine: depression drug ineffective in study
businessweek.com 14.9.2010
Neurocrine Biosciences Inc. said Tuesday a potential treatment for major depressive disorder conferred no benefit on patients in a midstage study.

The study on GSK561679 involved 150 patients and was conducted by partner GlaxoSmithKline. It compared the drug candidate with placebo.

Neurocrine said it plans to meet with GlaxoSmithKline in the coming months after full clinical data are available to discuss next steps for the program.
Other ongoing clinical trials on the drug are testing it against post-traumatic stress disorder, anxiety and alcoholism.

Shares of Neurocrine Biosciences fell 79 cents, or 12.6 percent, to $5.46 in after-hours trading after rising 18 cents to close at $6.26 during the regular trading session. (...)

What to Tell the Patients After a Trial Goes Awry (Hva sier man til pasienter etter at et forsøk har gått galt)
nytimes.com 23.8.2010
Dr. Joel Ross, the founder and chief executive of the Memory Enhancement Centers of New Jersey, makes his living enrolling subjects in drug company clinical trials that are testing drugs for Alzheimer’s disease, among others. (...)

Drug firms hiding negative research are unfit to experiment on people
guardian.co.uk 14.8.2010
Another pharmaceutical giant has settled a big compensation claim. So why are they allowed to go on misleading the public?

This week the drug company AstraZeneca paid out £125m to settle a class action. More than 17,500 patients claim the company withheld information showing that schizophrenia drug quetiapine (tradename Seroquel) can cause diabetes. So why do companies pay out money before cases get to court?

An interesting feature of litigation is that various documents enter the public domain. This is how we know about the tobacco industry's evil plans to target children, the fake academic journal that Elsevier created for Merck's marketing department, and so on.

One of the most revealing documents ever to come out of a drug company emerged from an earlier quetiapine case: an email from John Tumas, publications manager at AstraZeneca. In it, he helpfully admits that they do everything I say drug companies do. (...)

Astra Zeneca i mututredning
dagensmedicin.se 13.8.2010
Fler stora läkemedelsbolag har blivit kontaktade av justitiedepartementet i USA i samband med en granskning av mutor i läkemedelsbranschen.

Bland bolagen finns Astra Zeneca, Glaxo Smithkline, Pfizer och Merck, uppger TT.

Granskningen ska omfatta bland annat bolagens rekrytering av läkare för kliniska prövningar av läkemedel samt betalningar av konsulter, licensavtal och donationer till välgörande ändamål. (...)

Diabetes Drug Maker Hid Test Data on Risks, Files Indicate (Arkivdata indikerer produsent av legemiddel mot diabetes skjulte data for risiko)
nytimes.com 13.7.2010
By GARDINER HARRIS
In the fall of 1999, the drug giant SmithKline Beecham secretly began a study to find out if its diabetes medicine, Avandia, was safer for the heart than a competing pill, Actos, made by Takeda.

Avandia’s success was crucial to SmithKline, whose labs were otherwise all but barren of new products. But the study’s results, completed that same year, were disastrous. Not only was Avandia no better than Actos, but the study also provided clear signs that it was riskier to the heart.

But instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law. (...)

(Anm: Avandia (rosiglitazone) - informasjon versus kunnskap og visdom - hvem visste hva? (mintankesmie.no).)

GSK is accused of trying to suppress editorial on rosiglitazone (GSK er anklaget for å forsøke å forhindre trykking av lederartikkel på rosiglitazone (Avandia))
BMJ 2010;340:c2654 (19 May)
GlaxoSmithKline faces several new issues over its drug rosiglitazone (Avandia) and possible cardiovascular problems.

The company has had to answer reports that it had asked the European Heart Journal not to publish in print an online editorial that was critical of the drug. It was also reported to have settled lawsuits relating to rosiglitazone and has faced calls for the US Food and Drug Administration to stop an international trial and demands from members of Congress asking why the drug had not been recalled.

The company denied charges, first reported at www.cardiobrief.org, that it had tried to prevent the European Heart Journal from publishing in its print edition an online editorial, "The rise and fall of rosiglitazone," by Steven Nissen of the Cleveland Clinic (2010;31;773-6, doi:10.1093/eurheartj/ehq016). In 2007 Dr Nissen raised the issue of possible cardiovascular problems with rosiglitazone in a paper in the New England Journal of Medicine (2007;356:2457-71). (...)

Criminal Investigations (Etterforskning)
JAMA. 2010;303(14):1358 (April 14)
US Food and Drug Administration (FDA) Commissioner Margaret Hamburg, MD, vowed that her agency is committed to improving the oversight and effectiveness of its Office of Criminal Investigations (OCI).

Hamburg's vow came in a March 4 letter to Sen Chuck Grassley (R, Iowa), who had requested a review in 2009 by the Government Accountability Office (GAO) into allegations of lax standards and poor responsibility in the FDA's criminal division. The GAO report (http://www.gao.gov/new.items/d10221.pdf) found the FDA's oversight of its OCI was limited, noting that 24 assessments of field offices, intended to ensure compliance with investigative policy, should have been completed by August 2009, but only 7 were finished. One office had not been assessed in more than 10 years. The OCI investigates a wide variety of criminal activities outside of the FDA, including the manufacture and sale of counterfeit drugs and illegal marketing of drugs.

Grassley, in a press release, indicated he was encouraged by the FDA commissioner's response. "Having the FDA leadership focused on fixing what's broken is the first, very important step needed." (...)

Novo Nordisk-insider skal et år i spjældet
politiken.dk 8.4.2010
(...) En tidligere ansat i medicinalkoncernen Novo Nordisk skal et år i fængsel for insiderhandel. (...)

Den tidligere Novo-mand blev suspenderet fra sit job tilbage i sommeren 2008. Koncernen oplyste dengang, at han ikke havde ledelsesansvar: »Men har haft adgang til information, der kan påvirke Novo Nordisks aktiekurs«, oplyste Novo.

Sagen går i al sin enkelthed ud på, at den tidligere medarbejder brugte intern viden til at score kassen via aktiekøb og -salg. (...)

Psychiatrists' Relationships With Pharmaceutical Companies
JAMA. 2010;303(12):1192-1193 (March 24/31)
Part of the Problem or Part of the Solution?

Psychiatrists have rarely enjoyed a surplus of public trust. During the past 3 years, public trust in psychiatry has been further undermined with accusations that several leading academic psychiatrists failed to disclose financial conflicts of interest. Sen Charles Grassley (R, Iowa), ranking member of the Finance Committee, has thus far accused 7 psychiatrists of failing to disclose income from pharmaceutical companies. As public trust in the pharmaceutical industry has plummeted, the close connection between leading psychiatrists and the pharmaceutical industry, once a sign of progress for the profession, is now cited as evidence of corrupt influence. (...)

(Anm: Interessekonflikter, bestikkelser og korrupsjon (mintankesmie.no).)

(Anm: Når er et synspunkt en interessekonflikt? (When is a point of view a conflict of interest?) BMJ 2016;355:i6194 (Published 23 November 2016).)

(Anm: Høyresiden har størst mistillit til journalistikken. (…) Videre mente 63 prosent at journalister favoriserer kilder som mener det samme som dem. (aftenposten.no 13.2.2017).)

(Anm: Mina Ghabel Lunde, journalist. Når kilder også er venner. Pressen skal unngå bindinger som skaper usikkerhet om lojalitet. Da kan ikke journalister omgås sine kilder privat. (aftenposten.no 8.2.2017).)

(Anm: Ingen gratis lunsj for leger: Sponsede måltider knyttet til flere resepter (No free lunch for docs: Sponsored meals linked to more prescriptions) (mmm-online.com 20.6.2016).)

Ensuring Integrity in Industry-Sponsored Research
JAMA. 2010;303(12):1196-1198 (March 24/31)
Primum Non Nocere, Revisited

The most fundamental principle of medicine, primum non nocere, holds for every physician, whether functioning as a clinician providing direct patient care; as a researcher, reviewer, or editor involved in medical publishing; or as an administrator overseeing an academic institution, health care organization, or pharmaceutical company research program. In all situations affecting patients, physicians must do no harm. (...)

When drug makers' profits outweigh penalties
washingtonpost.com 21.3.2010
Prosecutor Michael Loucks remembers clearly when attorneys for Pfizer, the world's largest drug company, looked across the table and promised it wouldn't break the law again. It was January 2004, and the lawyers were negotiating in a conference room on the ninth floor of the federal courthouse in Boston, where Loucks was head of the health-care fraud unit of the U.S. Attorney's Office. One of Pfizer's units had been pushing doctors to prescribe an epilepsy drug called Neurontin for uses the Food and Drug Administration had never approved. In the agreement the lawyers eventually hammered out, the Pfizer unit, Warner-Lambert, pleaded guilty to two felony counts of marketing a drug for unapproved uses. New York-based Pfizer agreed to pay $430 million in criminal fines and civil penalties, and the company's lawyers assured Loucks and three other prosecutors that Pfizer and its units would stop promoting drugs for unauthorized purposes. What Loucks, who was acting U.S. attorney in Boston until November, didn't know until years later was that Pfizer managers were breaking that pledge not to practice off-label marketing even before the ink was dry on their plea. (...)

Registration of observational studies (Registrering av observasjonsstudier)
Editorials
BMJ 2010;340:c950 (18 February)
The next step towards research transparency

Observational studies, such as cohort and case-control studies, are an important form of medical research, but they are also vulnerable to bias and selective reporting.1 They often produce large datasets that can be subjected to multiple analyses. Researchers may then craft a paper that selectively emphasises certain results, often those that are statistically significant or provocative. These decisions may reflect strong financial or academic interests and prior beliefs. At present, consumers of observational research cannot easily distinguish hypothesis driven studies from exploratory, post hoc data analyses. Researchers do not routinely disclose the number of additional analyses performed. Nor is there any satisfactory way to know whether the research questions or methods of statistical analysis diverged from those initially planned. It has been observed that there is "little or no penalty" for data dredging and selective reporting. Rather than attracting censure it can "get you into the BMJ and the Friday papers."2 (...)

Norge vill sätta stopp för spökskrivare
lakemedelsvarlden.se 15.2.2010
Den senaste tidens avslöjanden att artiklar om läkemedelsstudier allt som oftast författas av andra än de som utfört forskningen och att dessa andra är spökskrivare betalda av läkemedelsföretagen har väckt debatt i Norge. Nu väntar tydligare regler mot spökskriveri i grannlandet. (...)

Anledningen är en amerikansk undersökning som nyligen publicerades i PLos Medicine som visar att få amerikanska forskningsinstitutioner har några regler mot de spökskriverier som läkemedelsföretag visat sig inte på något sätt vara främmande för.

Bara ett fåtal av de akademiska institutionerna hade enligt undersökningen regler som uttryckligen förbjuder detta. Hur spökskriveriet går till och hur utbrett det är beskrivs i senaste numret av Läkemedelsvärlden.

– Den här okulturen som vi nu fått inblick igenom de amerikanska rättstvisterna mot läkemedelsföretag innebär att systematiska kunskapssammanfattningar och begreppet evidensbaserad medicin förorenas, säger Jørund Straand till tidningen.

– Kanske är det dags att sluta tro på resultat från läkemedelsprövningar sponsrade av företagen. (...)

(Anm: Ghostwriting at Elite Academic Medical Centers in the United States
PLoS Med 7(2): e1000230 (February 2)
.)

Science as marketing (Forskning som reklame)
thestar.blogs.com 27.1.2010
A new peer-reviewed study paints a disturbing picture of the use and abuse of science by pharmaceutical companies to help them sell drugs.

Published in the latest edition of the Journal of Bioethical Inquiry, the study goes through several case studies of big drug companies using questionable science to boost the apparent effectiveness and/or safety of their products. Authors Glen Spielmans and Peter Parry sifted through internal court documents released to the public through lawsuits against the drug companies in one of the first peer-reviewed studies to rely on such documents. (...)

From Evidence-based Medicine to Marketing-based Medicine: Evidence from Internal Industry Documents (Fra bevisbasert medisin til reklamebasert medisin: Bevis fra interne industridokumenter)
Journal of Bioethical Inquiry 2010;1176-7529 (Print) 1872-4353 (Online) (January 21).
Abstract While much excitement has been generated surrounding evidence-based medicine, internal documents from the pharmaceutical industry suggest that the publicly available evidence base may not accurately represent the underlying data regarding its products. The industry and its associated medical communication firms state that publications in the medical literature primarily serve marketing interests. Suppression and spinning of negative data and ghostwriting have emerged as tools to help manage medical journal publications to best suit product sales, while disease mongering and market segmentation of
physicians are also used to efficiently maximize profits. We propose that while evidence-based medicine is a noble ideal, marketing-based medicine is the current reality.

The larger issue is how do we face the outside world when they begin to criticize us for suppressing data... AstraZeneca publications manager in internal
email 6 Dec 1999.(...)

Zebrafish make good 'guinea pigs' for human drugs
newscientist.com 18.1.2010
Zebrafish need Prozac like they need a bicycle, yet recording how various molecules affect their behaviour may be the perfect way to discover treatments for mental illness and neurological diseases.

Most brain drugs are variations on 50-year-old medicines, says Randall Peterson of Massachusetts General Hospital in Boston, so new ones can't come soon enough. Because zebrafish have a similar brain chemistry to humans, how they respond to certain drugs might indicate how the same drugs will affect people.

To investigate, Peterson's team exposed zebrafish embryos to thousands of drugs and recorded how each affected their reaction to a flash of light or a slight poke (Nature Chemical Biology, DOI: 10.1038/nchembio.307).

Meanwhile, Alexander Schier at Harvard University and colleagues measured how various drugs changed the sleep-wake cycles of zebrafish larvae (Science, DOI: 10.1126/science.1183090). (...)

Forskningssnyd i farmaindustrien
business.dk 10.12.2009
Undersøgelser viser, at medicinalindustrien snyder med forskningsresultaterne. Det sker af hensyn til indtjeningen, siger forsker. (...)

De groveste tilfælde er opdigtede forskningsresultater og forfalskede data, som to procent af alle forskere indrømmer, at de mindst en gang i karrieren har medvirket til. Mere udbredt er det at bedrive diskutabel forskningspraksis.

Det indrømmer 33 procent af forskerne at have været med til, dokumenterer undersøgelse af forskersnyd fra University of Edinburgh, som også påpeger, at forskningssnyd oftere forekommer blandt medicinske- og farmakologiske forskere end blandt andre forskere. (...)

Antidepressants: Benefit Of Reboxetine Not Proven (Antidepressiva: Nytte av Reboxetine ikke bevist)
medicalnewstoday.com 2.12.2009
There is no scientific proof that people suffering from depression can benefit from taking reboxetine. (...)

Despite several requests, Pfizer had steadfastly refused to provide IQWiG with a list of all published and unpublished data.

However, after the preliminary report was published, Pfizer and Essex Pharma decided to make the unpublished data and information on trials accessible. Only then was it possible to assess all three drugs based on complete data. (...)

(Anm: reboxetine (Edronax) (felleskatalogen.no).)

(Anm: Editorials. Safety, trust, and money are uncomfortable bedfellows. BMJ 2015;351:h5750 (Published 03 November 2015).)

(Anm: Reboxetine has no antidepressant effect at all. BMJ 2015; 351  (Published 03 November 2015) BMJ 2015;351:h5842.)

Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data
Arch Intern Med. 2009;169(21):1976-1985 (November 23)
Lessons for Postmarket Pharmaceutical Safety Surveillance

Background In September 2004, rofecoxib was voluntarily withdrawn from the worldwide market. Our objective was to determine whether and when analysis of published and unpublished placebo-controlled trials could have revealed cardiovascular risk associated with rofecoxib before its withdrawal as an example to inform future postmarket pharmaceutical safety surveillance efforts. (...)

Conclusion Cumulative pooled analysis of all randomized, placebo-controlled trials demonstrates a trend toward increased cardiovascular risk associated with rofecoxib compared with placebo as early as December 2000, the comparison reaching a P value of .05 by June 2001, nearly 3 years before the manufacturer's voluntary market withdrawal. (...)

(Anm: Bringing the FDA's Information to Market. Arch Intern Med. 2009;169(21):1985-1987 (November 23).)

Litigation uncovers biased reporting of gabapentin trials
BMJ 2009;339:b4816 (19 November)
All you need to read in the other general journals
Research documents made public during legal proceedings against drug manufacturers provide useful insights into the subtle (and often advantageous) changes that can occur between the protocol stages of a trial and final publication. When researchers recently scrutinised industry sponsored trials evaluating off-label use of gabapentin, they found that in eight of 12 trials the primary outcome in the published paper was different from the primary outcome specified in the protocol. In five trials, primary outcomes specified in the protocol were missing from the published paper. In six trials, the published paper reported a completely new primary outcome. In two trials, the primary outcome specified in the protocol was relegated to a secondary outcome in the published paper. The treatment effect (measured by the P value) and the primary outcome matched in just one of nine trials that were published in full. (...)

Trial Data on Anti-Seizure Drug Might Have Been Manipulated: Report
healthday.com 11.11.2009
Study found outcome measures differed between company documents, published reports

WEDNESDAY, Nov. 11 (HealthDay News) -- An unusual look at internal documents from a pharmaceutical company suggests that clinical data was manipulated to make a popular anti-seizure drug, gabapentin (Neurontin), look more effective than it actually was, thereby increasing possibilities for its off-label usage, according to a new report.

"This means we're not seeing the full picture, and the picture we are seeing is suspect because perhaps there was selective reporting of outcomes so that only the positive outcomes were reported," said Kay Dickersin, senior author of a paper reporting the alleged deception in the Nov. 12 issue of the New England Journal of Medicine. (...)

Outcome Reporting in Industry-Sponsored Trials of Gabapentin for Off-Label Use
NEJM 2009; 361(20):1963-1971 (November 12)
Background There is good evidence of selective outcome reporting in published reports of randomized trials. (...)

Results We identified 20 clinical trials for which internal documents were available from Pfizer and Parke-Davis; of these trials, 12 were reported in publications. For 8 of the 12 reported trials, the primary outcome defined in the published report differed from that described in the protocol. (...)

Conclusions We identified selective outcome reporting for trials of off-label use of gabapentin. This practice threatens the validity of evidence for the effectiveness of off-label interventions. (...)

Review: Reports on Pfizer Drug Studies Misleading
pharmpro.com 9.11.2009
Analysis of a dozen published studies testing possible new uses for a Pfizer Inc. epilepsy drug found that reporting of the results was often misleading, indicating the medicine worked better than internal company documents showed.

According to the report, when a company-funded study's primary finding wasn't favorable, that result was usually buried and something else positive was highlighted, without disclosing the switch. (...)

Less than half of completed trials are published
BMJ 2009;339:b3739 (15 September)
All you need to read in the other general journals

PLoS Med 2009;doi:10.1371/journal.pmed.1000144

Selective publication of clinical trials distorts the literature and denies doctors, patients, and researchers access to essential information about the safety and effectiveness of treatments. The full extent of selective publication is hard to determine, although a recent study of trials registered on ClinicalTrials.gov suggests it is still widespread.

Among a random sample of 677 trials completed by 2005, only 311 (46%) were published and traceable through Medline. Even fewer (96 out of 311 published trials (31%)) provided a citation on ClinicalTrials.gov to allow easy access to published results. Only 66% of trials reported their primary outcomes and 56% reported their secondary outcome. Trials sponsored by government agencies were no more likely to be published than trials sponsored by the drugs industry (47% (57/122) v 40% (144/357); P=0.22). (...)

Pfizer må betale 14 milliarder
nrk.no 2.9.2009
VERDENS STØRSTE: Verdens største legemiddelselskap har fått tidenes største bot i USA.

Verdens største legemiddelselskap hadde ikke dekning for det de lovet. Nå må de betale tidenes milliardbot. (...)

Den største summen, 1,3 milliarder dollar, må selskapet betale for ulovlig markedsføring av det betennelsesdempende legemiddelet Bextra. (...)

Boten er, ifølge Washington Post, den største som noen gang er ilagt i USA. (...)

NEJM & BMJ editors to challenge pharma conducting its own clinical trials
pharmatimes.com 27.8.2009
The pharmaceutical industry faces an ethical dilemma when it conducts trials on its own drugs, Dr Jeffrey Drazen Editor in Chief of the New England Journal of Medicine and Dr Fiona Godlee, Editor in Chief of British Medical Journal, will argue in the world famous debating chamber at Oxford Union this month alongside Guardian Bad Science columnist Ben Goldacre.

Clinical trials are central to the success of the industry, providing the bedrock of evidence for a medicine’s use. Typically, these studies are conducted and paid for by pharma: in other words, the medicines developed by industry are tested by the industry.

But is this a conflict of interest? Is it acceptable for industry to pay for and run clinical trials of its own medicines – either for the purposes of registration or subsequent use?

Arguing in industry’s favour at the PharmaTimes’ Great Oxford Debate will be Robert Ruffolo, former R&D President of Research at Wyeth, Scott Gottlieb, former FDA senior official and a frequentWall Street Journal columnist, and Vincent Lawton, ex-Managing Director of MSD and President of the Association of the British Pharmaceutical Industry. (...)

Merck, Schering-Plough in $42M Vytorin settlement
pharmpro.com 6.8.2009
NEW YORK (AP) — Merck and Schering-Plough say they will pay $41.5 million to settle class-action lawsuits filed by patients taking the cholesterol drugs Vytorin and Zetia.

The lawsuits claim that the companies purposefully delayed the release of study results showing the cholesterol treatments were no more effective than older, less expensive medications. The companies do not acknowledge any wrongdoing or liability as part of the settlement.

The settlement deal comes while Whitehouse Station, N.J.-based Merck & Co. is in the process of buying Kenilworth, N.J.-based Schering-Plough Corp. for $41.1 billion. (...)

Merck, Schering-Plough Reach Vytorin Settlement With State AGs
Thompson.com 17.7.2009
Merck & Co., Schering-Plough Corp. and their cholesterol joint venture Merck/Schering-Plough Pharmaceuticals reached a civil settlement with the attorneys general (AGs) of 35 states and the District of Columbia concerning the companies’ promotion of the drugs Vytorin and Zetia and the alleged delay in releasing the results of a related clinical trial.

According to the state enforcement officials, a nearly two-year delay in the release of the full results of the so-called ENHANCE clinical trial violated state consumer protection laws. The trial determined that Vytorin, a cholesterol-lowering drug consisting of a combination of the drugs Zetia and Simvastatin, was no more effective in reducing the formation of plaque in carotid arteries than the cheaper, generically available Simvastatin alone. During the delay in the release of the trial results, the companies heavily promoted Vytorin in direct-to-consumer (DTC) advertisements. (...)

Data About Zetia Risks Was Not Fully Revealed (Data for Ezetrol (Zetia) ble ikke fullstendig offentliggjort)
nytimes.com 21.12.2007
New evidence shows that the drug makers Merck and Schering-Plough have conducted several studies of their popular cholesterol medicine Zetia that raise questions about its risks to the liver, but the companies have never published those results.

Partial results of the studies, alluded to in documents on the Food and Drug Administration’s Web site, raise questions about whether Zetia can cause liver damage when used long term with other cholesterol drugs called statins.

Most of the millions of people who use Zetia take it along with a statin like Lipitor, Crestor or Zocor. Or they take it in a single pill, Vytorin, that combines Zetia with Zocor. (...)

(Anm: Zetia (ezetimibe); markesføres i Norge under handelsnavnet Ezetrol (Zetia i i USA.)

(Anm: Vytorin (ezetimibe and simvastatin); Vytorin er en kombinasjon av Schering-Ploughs Zetia (ezetimibe; fornorsket ezetimib) og Mercks Zocor (simvastatin).)

JAMA should change its policy on investigating competing interests, AMA says
BMJ 2009;339:b2936 (21 July)
The American Medical Association has recommended that the editors of its journal (JAMA) change its procedures for dealing with complaints over undisclosed conflicts of interest by journal authors. The journal laid out its procedures, which attracted much criticism, in an editorial in March (BMJ 2009;338:b1352, doi:10.1136/bmj.b1352).

The journal’s editorial said that people complaining about such conflicts of interest should remain silent while their complaints were investigated. (...)

Rebecca Patchin, chairwoman of the association’s board, said, "We anticipate JAMA’s procedures for resolving undisclosed conflicts of interest by journal authors will be improved."

The issue arose when Dr Leo raised the question of non-disclosure of conflicts of interest about an article published in JAMA about the use of escitalopram, problem solving therapy, or placebo in patients who had had a stroke (JAMA 2008;299:2391-400, doi:10.1001/jama.299.20.2391).

Dr Leo and Dr Lacasse wrote to JAMA and the New York Times saying that the study’s lead author, Robert Robinson of the University of Iowa, had not disclosed support from the drug’s manufacturer, Forest Laboratories. Dr Robinson and his coauthor later acknowledged industry support (JAMA 2009;301:1023-4). (...)

(Anm: Correction for Tanne, BMJ 339 (jul21 1) b2936. Published 29 July 2009, doi:10.1136/bmj.b3085 Cite this as: BMJ 2009;339:b3085.)

Novo-chefer risikerer fængsel
business.dk 16.7.2009
Den svenske bestikkelsessag, hvor Novo Nordisk var lidt for gavmilde over for en række svenske læger, kan sende de ansvarlige i fængsel. Strafferammen for bestikkelse i Sverige er fængsel i op til to år.

Den svenske anklagemyndighed er fast besluttet på at gå hele vejen i bestikkelsessagen mod Novo Nordisk. De ansvarlige risikerer op til to års fængsel i sagen, som den svenske anklagemyndighed bruger til at sende et klart signal. Tiderne med smøring i medicinalbranchen er ovre i Sverige, lyder budskabet til læger og medicinalselskaber. (...)

Novo Nordisk i svensk bestikkelses-skandale
business.dk 13.7.2009
De svenske myndigheder efterforsker Novo Nordisks rolle i en speget svensk bestikkelsesskandale. Angiveligt har Novo Nordisk sendt knap 200 svenske læger og sygeplejersker på ren fornøjelsestur til Sydafrika.

En fornøjelsestur til Sydafrika i 2006 har bragt Novo Nordisk i de svenske myndigheders søgelys.

Angiveligt har Novo Nordisk sponsoreret en tur til Sydafrika for knap 200 svenske læger og sygeplejersker, der i det daglige står for udskrivning af blandt andet medicin fra den danske medicinalgigant.

Derfor mistænker den svenske statsanklager Nils-Erik Schultz Novo Nordisk for bestikkelse og de deltagne læger og sygeplejersker for at have taget imod bestikkelsen. »Så er spørgsmålet: Hvis disse personer skal vælge mellem fem lægemidler, kan det så være, at de simpelthen bare skriver mere ud af den medicin fra det selskab, som lige har budt dem på en dejlig rejse,« siger Nils-Erik Schultz til den svenske avis Sydsvenska Dagbladet.

Fokus på rejsedeltagere
»Du skal som patient kunne stole på, at din læge er objektiv og ikke påvirket af noget lægemiddelselskab, Det er det, som denne her efterforskning handler om,« tilføjer statsanklageren.

På grund af sagens omfattende karakter har den svenske anklagemyndighed koncentreret efterforskningen omkring rejsedeltagerne fra Universitetssygehuset i Malmö. I alt otte personer fra sygehuset - fire læger og fire sygeplejersker - deltog i turen, og ifølge bilag, som Sydsvenska Dagbladet har set, så betalte Novo Nordisk knap halvdelen af turens pris på 50.000 kroner.

Det er helt efter reglerne, men ifølge Nils-Erik Schultz er mistanken, at Novo Nordisk har betalt 100 procent af udgifterne.

Det er angiveligt sket ved, at medicinalkoncernen under bordet har overført penge til sygehuset. De hemmelige penge mistænkes for at komme ved en overbetaling af test af lægemidler, som hospitalet har udført for Novo Nordisk. Derfor gennemgår den svenske statsanklager sammen med politimyndighederne i Skåne lige nu samtlige bankkonti tilhørende sygehuset på jagt efter de hemmelige penge. (...)

Ny bestikkelsessag rammer Novo Nordisk
politiken.dk 13.7.2009
(...) Den svenske statsanklager Nils-Erik Schultz siger til Jyllands-Posten, at det kan se ud som om, Novo Nordisk, der blandt andet sælger diabetesmedicin, har været meget gavmild overfor diabeteslægerne. (...)

Ifølge svensk lovgivning skal skatteyderne nemlig betale halvdelen af sådanne uddannelsesrejser. Nils-Erik Schultz mener dog, at dette regelsæt kan være sat ud af kraft, fordi Novo Nordisk betaler for medicinforsøg på svenske sugehuse og klinikker. Penge herfra kan være kanaliseret videre til brug for konferencen. (...)

Philippines Pres faces Senate over secret deal with big pharma
pharmatimes.com 13.7.2009
Philippines’ President Gloria Macapagal-Arroyo has been summoned to a Senate committee today to face charges that she has agreed a secret deal with multinational drugmakers which overturns plans to curb the prices of the country’s most widely-prescribed drugs.

Senator Manuel Roxas, who chairs the Senate Oversight Committee on Affordable Medicines, has called for the President and a number of her Cabinet colleagues to explain to the panel what went on during “her confidential meeting with representatives of multinational drug companies on July 8.”

That meeting was attended by representatives of Pfizer, Roche, the Philippine Chamber of the Pharmaceutical Industry and the Pharmaceutical and Healthcare Association of the Philippines (PHAP), among others. According to Sen Roxas, they had asked to meet the President in order to stop her from signing an executive order which would authorize the setting of Maximum Retail Prices (MRPs) on 22 widely-prescribed, essential drugs. (...)

MEDICAL ETHICS (MEDISINSK ETIKK)
Drug 'reports' found to be faked ("Legemiddelrapporter" er avslørt å være forfalsket)
healthzone.ca 22.6.2009
From the creation of fake academic journals, to bogus stories submitted to real journals, to falsified results in some of academia's most respected publications – the pharmaceutical industry has been rocked by allegations that the world's biggest drug companies put public relations above public safety.

As consumer advocate Peter Lurie put it recently: "I've seen no shortage of creativity emanating from the marketing departments of drug companies."

The allegations have come to light thanks to lawsuits in the United States and Australia seeking compensation for drug costs that the plaintiffs claim were too high. The suits allege the drug companies skewed academic investigations into their products, thereby driving up the price they could charge.

Trudo Lemmens, an associate professor of medical law at the University of Toronto, says it should not be left to the civil courts to uncover what he calls "publishing as marketing."

"You have to ask yourself, why isn't there more regulatory control?"

Lemmens would like to see tougher conflict-of-interest rules and more oversight of how drug trials are conducted, and the results published.

Some of the drugs involved in the lawsuits – including Vioxx and Fosamax – were later found to have adverse, and even deadly, side effects. Others, such as Zetia and Vytorin, were later found to be no more effective than much cheaper alternatives.

Merck & Co., maker of those drugs, has steadfastly defended its policies and products. (...)

Medicine's Not-So-Silent Killer: Studies Under Scrutiny
ivanhoe.com 3.7.2009
PORTLAND, Ore. (Ivanhoe Newswire) -- Each year, $84 billion is spent on drug development. The rush to create better pills and more effective medicine could be costing the people who take them more than their money -- it could cost them their health. Is medicine losing out to the almighty dollar? Are clinical trials rigged? The results skewed?

There's a lot on the line. The prescription drug market is a $162 billion dollar a year business. But some say the studies done to get these drugs to market can -- and are -- being manipulated.

"Negative studies? We don’t hear about them," Peter Lurie, M.D., Deputy Director of Public Citizen's Health Research Group, told Ivanhoe.

“Many medical journals are becoming marketing instruments for the drug companies," Sidney Wolfe, M.D., Director of Public Citizen's Health Research Group, said. (...)

A JAMA study found industry-sponsored research was positive 87 percent of the time compared with 65 percent of non-industry-sponsored research. UCLA professor Jerome Hoffman says it’s not just the companies that profit from positive results.

"The financial success of medical journals, particularly the major journals, is intimately tied to meeting the needs of the companies that sponsor these big studies," Dr. Hoffman told Ivanhoe. (...)

Dansk medicinalgigant beklager skandale
politiken.dk 26.6.2009
Novo Nordisk har indgået forlig med bagmandspolitiet og betaler 30 millioner kroner efter FN-skandale. (...)

Irak fik mad og medicin
Olie-for-mad-programmet betød, at Irak trods FN-embargoen mod landet kunne bruge nogle af sine mange oliemilliarder på fødevarer og medicin til befolkningen.

Flere tusinde virksomheder forbrød sig imidlertid mod FN-programmets regler og brugte bestikkelse i jagten på aftaler med Saddam Husseins styre i Bagdad.

Blandt dem altså Novo Nordisk, som tidligere har indgået en lignende aftale med de amerikanske myndigheder og betalt 18 millioner dollar svarende til cirka 100 millioner kroner tilbage. (...)

The 'Business' of Drugs: The Money behind Falsified Drug Research
opednews.com 17.5.2009
Last week we reported that a Dr. Karen Wagner, professor, psychiatrist and key researcher at the University of Texas was one of the latest targets caught in the net of U.S. Senator Chuck Grassley in his ongoing war against drug company corruption and undue financial influence on the U.S. Health industry.

Grassley's investigators initially found that pharmaceutical giant, GlaxoSmithKline paid the psychiatrist more than $160,000 between 2000 and 2005 while she was the director of child and adolescent psychiatry at the University of Texas Medical Branch in Galveston.

Wagner herself however, never reported more than $600. (yes, she reported no more than six hundred dollars).

Well, we said in our original report that this story was not going to go away – and it hasn't! (...)

Skarp kritik af Novo-chefen i bestikkelsessag
business.dk 15.5.2009
Novo Nordisk-topchef Lars Rebien Sørensen er gået i skjul efter medicinalkoncernens forlig i bestikkelsesskandalen i olie for mad-programmet. Han møder nu hård kritik for sin håndtering af sagen. Eksperter mener, håndteringen skader Novo Nordisk.

Kritikken hagler ned over Novo Nordisk-topchef Lars Rebien Sørensen, der er gået i skjul for pressen oven på den pinlige sag om Novo Nordisk- bestikkelse i Irak.

Selvom han netop har betalt en historisk høj erstatning for at undgå en truende sag med de amerikanske myndigheder, har dansk erhvervslivs etiske førehund gemt sig bag sin kommunikationschef i skandalesagen om Saddam Husseins oliemilliarder. (...)

Medicingigant ville miskreditere læger
politiken.dk 7.4.2009
Retssag afslører, at giganten Merck tilsyneladende ville påvirke læger til at se mere positivt på farlig gigtmedicin.

Et af verdens største medicinalfirmaer, Merck, gjorde sig i 1999 tilsyneladende store anstrengelser for at beskytte sin gigtmedidin Vioxx mod kritik.

Så store, at man udarbejdede interne lister over læger og forskere, som man enten ønskede at 'neutralisere' eller at 'miskreditere'.

De oplysninger er kommet frem under en retssag, der netop nu finder sted i Byron Bay i Australien, skriver British Medical Journal.

Her har en 58-årig mand, Graeme Peterson, og flere hundrede andre australiere, stævnet Merck. (...)

Fattige er prøvekaninar for medisin
nrk.no 22.3.2009
Praksisen byt med menneskerettane, seier president Sven Mollekleiv i Noregs Røde Kors.

Norske ekspertar tordnar mot legemiddelindustrien som utnyttar folk i u-land.

Legemiddelindustrien flyttar testinga av medisinar til land i den tredje verda og til Aust-Europa for å spare pengar. Det er billigare og mindre byråkrati i fattige land enn i Vesten.

- Har alt å tape
Menneske i fattige land blir dermed prøvekaninar for medisinar som skal brukast i rike land, viser ein ny forskingsrapport frå Duke University i North Carolina, USA.

- Menneska forsøka blir utførte på har alt å tape. Dei blir utsette for all risiko og ingen vinning, seier professorar ved Duke University.

Professor Eric Peterson er redd forskinga i fattige land ikkje fylgjer den same etiske standarden som i Vesten. Han meiner norske styresmakter må sørgje for snu utviklinga. (...)

Cochrane-studie visar snedvriden publicering
lakemedelsvarlden.se 21.1.2009
Ytterligare en rapport konstaterar nu att läkemedelsstudier med positiva resultat publiceras oftare än de med negativa resultat. Den här gången är det ansedda Cochrane-institutet som gjort en genomgång.

METAANALYS Forskarna bakom Cochrane-rapporten har granskat fem studier som i sin tur undersökt om det finns en publikations-bias inom läkemedelsområdet. Slutsatsen av denna metastudie är att positiva resultat om läkemedel publiceras betydligt oftare än negativa.

Enligt rapporten publiceras 41 procent av alla läkemedelsstudier med negativa resultat. Bland de studier som har positiva resultat publiceras istället 73 procent. Därmed finns det en tydlig snedvridning åt det positiva hållet i medicinska databaser konstaterar rapportförfattarna med Sally Hopewell i spetsen.

De skriver också att det är viktigt för de forskare som gör översiktsartiklar eller metaanalyser att vara medvetna om snedvridningen. För att få korrekta resultat i en metaanlys av läkemedel rekommenderar författarna att man också tar med resultat från icke-publicerade studier. (...)

People's Pharmacy: Medicines pay for medical breakthroughs
chron.com 18.1.2009
(...) When you look at last year’s crop of Food and Drug Administration drug approvals, there are few breakthroughs. A new antidepressant was approved called Pristiq. The generic name for this medicine is desvenlafaxine. If that sounds familiar, there’s a good reason. The generic name for the antidepressant Effexor, introduced in 1993, is venlafaxine. In other words, these drugs are chemically related.

The same company makes both Effexor and Pristiq. Why would Wyeth spend countless millions to develop a similar antidepressant? Effexor went off patent in 2006, and a long-acting version, Effexor XR, will lose its patent protection next year. (...)

(Anm: Venlafaxine-Induced Cytotoxicity Towards Isolated Rat Hepatocytes Involves Oxidative Stress and Mitochondrial/Lysosomal Dysfunction. Purpose: Depression is a public disorder worldwide. Despite the widespread use of venlafaxine in the treatment of depression, it has been associated with the incidence of toxicities. Hence, the goal of the current investigation was to evaluate the mechanisms of venlafaxine-induced cell death in the model of the freshly isolated rat hepatocytes. (…) Conclusion: Therefore, our data indicate that venlafaxine induces oxidative stress towards hepatocytes and our findings provide evidence to propose that mitochondria and lysosomes are of the primary targets in venlafaxine-mediated cell damage. Adv Pharm Bull. 2016 Dec;6(4):521-530.)

(Anm: Akutt toksisitet for 8 antidepressiva: hva er deres virkningsmekanismer? (Acute toxicity of 8 antidepressants: what are their modes of action? Currently, the hazard posed by pharmaceutical residues is a major concern of ecotoxicology. Most of the antidepressants belong to a family named the Cationic Amphipathic Drugs known to have specific interactions with cell membranes. The present study assessed the impact of eight antidepressants belonging to selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors.) Chemosphere. 2014 Aug;108:314-9. Epub 2014 Feb 14. (PDF).)

(Anm: Cytotoxic immune cell in sick and healthy skin a key to understanding vitiligo. With the aid of thousands of skin biopsies and over a hundred kilograms of skin, researchers at Karolinska Institutet have observed how two subgroups of immune cell behave in healthy skin. This functional dichotomy is preserved in the inflammatory diseases psoriasis and vitiligo. The study, which is published in the journal Immunity, opens the way for more targeted local treatments for patchy inflammatory skin disorders. (medicalnewstoday.com 22.2.2017).)

Lax on Examining Potential Conflicts of Interest in Drug Trials, HHS OIG Report Says (Slapp granskning av mulige interessekonflikter for legemiddelforsøk, ifølge HHS OIG Report)
kaisernetwork.org 12.1.2009
The efforts of FDA officials responsible for screening physicians involved in patient trials of pharmaceutical drugs and medical devices, as part of the agency's product approval process, appear to be inadequate in identifying potential conflicts of interest, according to a report released on Monday by the HHS Office of the Inspector General, the AP/Austin American-Statesman reports. For the study, investigators examined 118 applications for newly approved medications from 2007. The study found that 42% of the applications did not disclose complete financial information and fewer than 1% of the researchers included information regarding potential conflicts of interest (Alonso-Zaldivar, AP/Austin American-Statesman, 1/12).

Of the 1% who did disclose a potential conflict of interest, nearly all disclosed just one financial interest, according to the study. The study also found that in 31% of the applications that included the required disclosures, FDA reviewers failed to state that they had examined the information. In 20% of the applications in which disclosures were made of significant financial conflicts, reviewers from FDA and the sponsoring companies did not do anything to address the conflicts, the study found (Harris, New York Times, 1/12).

The report stated, "We found a number of limitations in FDA's oversight, leaving FDA unable to determine whether (drug companies) submit financial information for all clinical investigators." The report added that such limitations "could result in FDA being unaware of a clinical investigator's financial interest, and thus unable to gauge its potential bias on clinical trial results." According to the AP/American-Statesman, the "issue is not scientists' compensation for supervising drug development tests but the conflicts that could arise from other rewards, such as honoraria, grants and stock options" (AP/Austin American-Statesman, 1/12). The report called on FDA to improve its conflict of interest oversight procedures, enforce the financial disclosures policy for companies, ensure that reviewers examine the disclosures, and conduct the oversight before patient trials are launched. (...)

Clinical Studies in the Crossfire
en.epochtimes.com 29.12.2008
Proof of efficacy for drugs and its inherent limitations (...)

Sex-for-prescription scandal engulfs Italy's healthcare sector
pharmatimes.com 5.12.2008
An Italian drugs supplier bribed doctors and pharmacists across the country to issue bogus prescriptions in return for cash and sex with Colombian prostitutes, it has emerged.

Forty four people, including medics, pharmacists and drugs supply staff across south and central Italy have been held, some under house arrest, in connection with the 10 million euro scam, which is the latest blow to the country's scandal-hit health sector.

The health staff are believed to have pocketed 5% of the prescriptions' cost, in return for inflating the suppliers' bill to the Italian health service. According to La Repubblica newspaper, representatives of "various pharmaceutical companies" were also involved in the scam, but it did not elaborate on what role they played.

Earlier this year PharmaTimes reported how officials in Italy's medicines regulatory agency Aifa (the Italian Agency for Pharmaceuticals), drugs company lobbyists had been arrested after police found evidence that money had changed hands in return for the falsification of clinical data required for drug licences. (...)

Commenting on events, the junior Italian health minister Ferruccio Fazio said the doctors and pharmacists involved would have their licences suspended. But he said they represented only a small minority of practising health professionals in Italy.

"We're talking about only around 50 individuals. In the whole sector there are over 100,000," he said. (...)

Is there evidence for biased reporting of published adverse effects data in pharmaceutical industry-funded studies?
British Journal of Clinical Pharmacology 2008;66(6):76 773 (31 July)
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT

• Industry-funded studies tend to emphasize favourable beneficial effects of the sponsor's product, but we do not know if reports of adverse effects are downplayed.

• Pharmaceutical companies are required to collate and accurately report adverse effects data in order to fulfil regulatory requirements. (...)

CONCLUSIONS
Our review indicates that industry funding may not be a major threat to bias in the reporting of the raw adverse effects data. However, we are concerned about potential bias in the interpretation and conclusions of industry-funded authors and studies. (...)

Drug licences for cash scandal unfolds in Italy
pharmatimes.com 27.6.2008
The director of Italy's medicines regulatory agency has been suspended along with another top official, as the drug licences-for-cash scandal surrounding the organisation continues to unfold.

Nello Martini, director of Aifa (the Italian Agency for Pharmaceuticals), has been suspended along with Caterina Gualano, head of medicines registration for the agency. The development follows a two-year investigation in which police found evidence that money had changed hands in return for the falsification of clinical data required for drug licences.

Earlier this month PharmaTimes World News reported how Pasqualino Rossi, one of Aifa's most senior representatives at the European Medicines Agency (EMEA), had been arrested along with another Aifa official and five drugs company lobbyists in connection with the scandal. (...)

Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial
By Alison Bass. 260 pp. Chapel Hill, NC, Algonquin Books of Chapel Hill, 2008. $24.95. ISBN 978-1-56512-553-7.
NEJM 2008; 358:2852 (June 26)
In July 2003, Rose Firestein, a tenacious lawyer working with the New York State attorney general's office on a consumer fraud lawsuit against GlaxoSmithKline, noticed something curious on the Web site of the Food and Drug Administration (FDA) — a press release stating that three clinical trials of the company's antidepressant Paxil (paroxetine) in children with depression showed that the drug was no more effective than a placebo. Firestein was shocked, given that Paxil was the second most widely prescribed antidepressant for children.

Firestein kept digging and quickly discovered that GlaxoSmithKline had actually conducted nine clinical trials with Paxil but had published just one of them. What the drug maker was hiding from the public was the bad news about Paxil: it did no better than a placebo in at least two of the unpublished studies, and there was disturbing evidence that patients who took Paxil were nearly three times as likely to experience suicidal feelings, thoughts, and behavior as those who took a placebo. (...)

The FDA scale-up: good for big pharma or not?
genengnews.com 7.5.2008
Fact: the FDA relies on user fees since the 1990s with the goal of speeding up drug approvals, meaning it is severely underfunded by the federal government and has not been able to fulfill it's mission based on that alone...

NOW the FDA wants to fill more than 1,300 posts in the upcoming months (article). Part of that are filling of empty positions already allocated (600), part are new positions that are being created (700) in order to better deal with the increase in drug applications and a more rigorous screening process. (...)

Report Claims Clinical Trials Miss Many Populations (Rapport hevder kliniske forsøk utelater mange grupper av befolkningen)
washingtonpost.com 1.4.2008
TUESDAY, April 1 (HealthDay News) -- A new analysis of the American clinical trial process suggests that the system for testing new drugs has routinely excluded or under-represented women, older people, minorities, disabled individuals and rural populations for decades.

"We've got a big problem," said Daniel S. Goldberg, chief policy adviser for the report. "And it's extremely urgent that we fix it. Because we're trying to figure out how to streamline health care and make people healthy, of course. And the fact that we have under-representation in clinical trials undermines both of these goals and undermines the quality of the evidence we come up with." (...)

Bitter Pill
wweek.com 2.4.2008
A Portland doc flips on big pharma and reveals its “dirty little secret.”

DOC BITES MEDICINE: OHSU professor Erick Turner doesn’t expect the drug industry to run clinical trials. “They would not want to touch me with a 10-foot pole, unless it had a sharp end on it.”

Ten percent of Americans—children, teens and adults—take antidepressants. Whether it’s Prozac, Paxil, Lexapro, Effexor or Cymbalta, 30 million of us take a pill daily in hopes it will keep dark moods at bay. Antidepressants are the most prescribed family of drugs in America, an $11.9 billion market in the U.S. in 2007. (...)

The paper has given Turner not rock-star status, perhaps, but at least a level of notoriety in a profession where physicians typically labor in anonymity. Since the paper’s publication, Turner has become a go-to source for reporters writing about depression and antidepressants. (...)

Evidence against Vytorin firms found (Oppdaget bevis mot Vytorin-firmaer)
boston.com 1.4.2008
TRENTON, N.J. - A congressional committee, investigating whether the makers of cholesterol drug Vytorin withheld data that would hurt sales, released new evidence supporting such suspicions yesterday.

The Senate Finance Committee said even the researcher who led a crucial study of the drug accused Merck & Co. and partner Schering-Plough Corp. of withholding negative results to boost sales.

A letter from the committee's ranking Republican, Senator Chuck Grassley of Iowa, states that delaying the results affected medical decisions and put financial burdens on patients and the federal government, which has paid hundreds of millions of dollars for Vytorin since the study ended nearly two years ago. (...)

Could full data disclosure avert scandal?
fiercepharma.com 25.3.2008
New calls for old drug data in the U.K. have experts second-guessing big drug-safety scandals. If scientists and regulators had had access to every bit of data on Vioxx from the get-go, for instance, would heart attacks and strokes have been averted? Ditto Avandia? "People might have realized that the claims being made for the drug were overblown and coy to the point of being fraudulent," one expert told the Associated Press. (...)

Too Much Information? Study Shows How Ignorance Can Be Influential
sciencedaily.com 25.3.2008
ScienceDaily (Mar. 24, 2008) — University of Southern California researchers provide a challenge to the classic economic model of information manipulation, in which knowing more than anybody else is the key to influence. Instead, economists Isabelle Brocas and Juan D. Carrillo present a situation -- commonly observed in real life -- in which all parties have access to the same information, but one party still manages to control public opinion. (...)

Seroxat lessons
ft.com 9.3.2008
Efforts by British medicine regulators to prosecute GlaxoSmithKline for allegedly delaying and playing down warnings about suicidal feelings in children taking Seroxat, its antidepressant, have collapsed after more than four years. Everyone involved should draw the lessons far more swiftly.

The regulatory framework has improved, partly in response to the GSK case. Drug companies are now required to register and report to regulators more extensively on side-effects identified during clinical trials conducted within the European Union. They also voluntarily and publicly disclose details of trials. (...)

Glaxo Escapes Prosecution on Seroxat Disclosure
therapeuticsdaily.com 6.3.2008
LONDON (MarketWatch) -- Britain's top drug regulator on Thursday chided GlaxoSmithKline for not quickly releasing data on increased suicidal risk in patients under 18 who used its Seroxat antidepressant drug, but declined to press criminal charges.

The Medicines and Healthcare products Regulatory Agency, after four years of investigating and poring over one million pages of evidence, said there wasn't a "realistic" prospect that it could get a criminal conviction of GlaxoSmithKline GSK.

The regulator said the law at the time -- 2003 -- wasn't clear enough. In particular, the MHRA said the rules for disclosing (...)

Lilly Waited Too Long to Warn About Schizophrenia Drug, Doctor Testifies (Lilly ventet for lenge med advarsel om schizofreni-legemiddel, ifølge leges vitnesbyrd)
nytimes.com 8.3.2008
ANCHORAGE — Eli Lilly, the drug maker, could and should have warned physicians as early as 1998 about the link between Zyprexa, its best-selling schizophrenia medicine, and diabetes, an expert witness told jurors Friday in a lawsuit that claims that Zyprexa has caused many mentally ill people to develop diabetes.

Instead, Lilly hid Zyprexa’s risks from doctors to protect the drug’s sales, according to the witness, Dr. John Gueriguian. Lilly waited until 2007 to add strong warnings to Zyprexa’s label to reflect the drug’s tendency to cause severe weight gain and blood sugar changes.

Lilly setter "profitt foran forbrukerens anliggende", sa Dr. Gueriguian på slutten av sitt fire timers vitnemål. (...) (Lilly put “profit over concern of the consumer,” Dr. Gueriguian said Friday near the end of four hours of testimony.)

Hasjrøyking fremmer sinnslidelser
nrk.no 22.8.2007
Ny forskning viser at hasjrøyking øker risikoen for alvorlige sinnslidelser som psykose og schizofreni. Professor i sosiologi ønsker nå Frederic Hauge med på laget i en kampanje mot hasjrøyking. (...)

(Anm: 50.000 nordmenn vil utvikle schizofreni i løpet av livet. - De som lider av denne psykoselidelsen har tanker om verden som ikke stemmer, sier ekspert. (…) Uklare symptomer i starten. Symptomer på Schizofreni utvikler seg over tid, og er i starten litt uklare. Ofte blir de mer fremtredende etter hvert. - Da vises blant annet sosial tilbaketrekning, man mister kontakt med virkeligheten, har vrangforestillinger, hallusinasjoner, tap av matlyst og tap av hygiene. Det er store individuelle variasjoner og mange opplever det som en berg- og dalbane, sier Tove Gundersen, som er generalsekretær i Rådet for psykisk helse. (kk.no 26.9.2016).)

(Anm: Katteparasitt kan gi schizofreni og tvangslidelser. Forskere har funnet en sammenheng mellom katteparasitten Toxoplasma gondii og utviklingen av forskjellige psykiske lidelser hos mennesker. (…) En parasitt fra katteavføring, T. gondii, kan sette fast seg i menneskehjernen og føre til schizofreni, manisk depressiv sinnslidelse, avhengighet og tvangstanker. (nrk.no 29.6.2015).)

(Anm: No, Your Cat Isn't a Threat to Your Mental Health. (…) But mental health worries aside, pregnant women should still be cautious about exposure to cat litter boxes, another researcher warned. "There is good evidence that T. gondii exposure during pregnancy can lead to serious birth defects and other health problems in children," said study senior author Dr. James Kirkbride. (medicinenet.com 21.2.2017).)

(Anm: Angstbehandling spres til utlandet. Her er nederlandske psykologer i Bergen for å lære om behandlingen som kan kurere tvangstanker på fire dager. Nå spres behandlingsopplegget til andre sykdommer og utover Norges grenser. (dagensmedisin.no 21.12.2016).)

(Anm: Schizofreni kopplas till TBE-smitta. Det kan finnas en koppling mellan virusinfektioner som TBE och neuropsykiatriska sjukdomar som schizofreni. Det har svenska forskare kommit fram till i en studie som presenterades på en konferens i San Diego på måndagen. (svd.se 6.11.2007).)

(Anm: Scientists find chemical pathway responsible for schizophrenia symptoms. Recent studies have suggested that kynurenic acid (KYNA) plays a key role in the pathophysiology of schizophrenia. People with schizophrenia have been shown to possess higher levels of KYNA than healthy individuals. KYNA helps to metabolize tryptophan - an essential amino acid that, in turn, helps the body to produce the "happiness" neurotransmitter serotonin, and the vitamin niacin. (medicalnewstoday.com 9.2.2017).)

(Anm: Psykose. Alle mennesker kan utvikle psykose. - Balansegangen mellom opplevd stress og ballast til å stå imot, er avgjørende, forteller psykiater. (…) - Stress er et sentralt tema. For eksempel har vi forskjellige måter å takle en belastende hendelse på jobb på. (…) - Man kan kalle det en forvirringstilstand, selv om heller ikke det er helt dekkende. (…) Symptomer ved psykose. Tidlige tegn kan være at man: (…) - Det er en kjempebelastning å ha en psykose. Mange blir redde og opplever ting de ikke forstår. Man vet at noen mennesker kan få tanker og impulser om å ta sitt eget liv, legger hun til. (lommelegen.no 13.6.2016).)

(Anm: Psychosis: Link to brain inflammation antibodies raises new treatment hope. For the first time, researchers reveal that some people presenting with a first episode of psychosis have specific antibodies in their blood. The antibodies are the same ones known to cause encephalitis or brain inflammation. The discovery raises the question of whether the removal of these antibodies could be an effective treatment for psychosis as it is for encephalitis. The researchers - led by Belinda R. Lennox, a professor in the department of psychiatry at the University of Oxford in the United Kingdom - report their findings in The Lancet Psychiatry. (…) Previous studies have already fueled discussion about the role antibodies targeting neural proteins may play in psychosis. For example, a study reported in 2015 of children experiencing their first episode of psychosis, also found links to an antibody response to NMDAR. (medicalnewstoday.com 9.12.2016).)

(Anm: Psykose som målestokk for tvungent psykisk helsevern. Sammendrag Abstract  Denne artikkelen handlar om vilkåra for tvungent psykisk helsevern. Det er særleg fokusert på ei drøfting omkring det såkalla hovudvilkåret etter lov om psykisk helsevern (phvl.) § 3-3 (1) nr. 3. I artikkelen vert det drøfta om dagens rettsregel og dei vurderingstema den set opp, gjer ei god avgrensing sett i høve til føremåla med tvungent psykisk helsevern. Det vert òg skissert ei betre løysing for tolking av vilkåret. Kritisk juss03 / 2016 (Volum 2) Side: 217-237DOI: 10.18261/issn.2387-4546-2016-03-03.)

(Anm: Psykose forbundet med lave nivåer av fysisk aktivitet. (Psychosis associated with low levels of physical activity. A large international study of more than 200,000 people in nearly 50 countries has revealed that people with psychosis engage in low levels of physical activity, and men with psychosis are over two times more likely to miss global activity targets compared to people without the illness.) (medicalnewstoday.com 26.8.2016).)

Hasjrøyking fremmer sinnslidelser
nrk.no 22.8.2007
Ny forskning viser at hasjrøyking øker risikoen for alvorlige sinnslidelser som psykose og schizofreni. Professor i sosiologi ønsker nå Frederic Hauge med på laget i en kampanje mot hasjrøyking. (...)

(Anm: 50.000 nordmenn vil utvikle schizofreni i løpet av livet. - De som lider av denne psykoselidelsen har tanker om verden som ikke stemmer, sier ekspert. (…) Uklare symptomer i starten. Symptomer på Schizofreni utvikler seg over tid, og er i starten litt uklare. Ofte blir de mer fremtredende etter hvert. - Da vises blant annet sosial tilbaketrekning, man mister kontakt med virkeligheten, har vrangforestillinger, hallusinasjoner, tap av matlyst og tap av hygiene. Det er store individuelle variasjoner og mange opplever det som en berg- og dalbane, sier Tove Gundersen, som er generalsekretær i Rådet for psykisk helse. (kk.no 26.9.2016).)

(Anm: Katteparasitt kan gi schizofreni og tvangslidelser. Forskere har funnet en sammenheng mellom katteparasitten Toxoplasma gondii og utviklingen av forskjellige psykiske lidelser hos mennesker. (…) En parasitt fra katteavføring, T. gondii, kan sette fast seg i menneskehjernen og føre til schizofreni, manisk depressiv sinnslidelse, avhengighet og tvangstanker. (nrk.no 29.6.2015).)

(Anm: No, Your Cat Isn't a Threat to Your Mental Health. (…) But mental health worries aside, pregnant women should still be cautious about exposure to cat litter boxes, another researcher warned. "There is good evidence that T. gondii exposure during pregnancy can lead to serious birth defects and other health problems in children," said study senior author Dr. James Kirkbride. (medicinenet.com 21.2.2017).)

(Anm: Angstbehandling spres til utlandet. Her er nederlandske psykologer i Bergen for å lære om behandlingen som kan kurere tvangstanker på fire dager. Nå spres behandlingsopplegget til andre sykdommer og utover Norges grenser. (dagensmedisin.no 21.12.2016).)

(Anm: Schizofreni kopplas till TBE-smitta. Det kan finnas en koppling mellan virusinfektioner som TBE och neuropsykiatriska sjukdomar som schizofreni. Det har svenska forskare kommit fram till i en studie som presenterades på en konferens i San Diego på måndagen. (svd.se 6.11.2007).)

(Anm: Scientists find chemical pathway responsible for schizophrenia symptoms. Recent studies have suggested that kynurenic acid (KYNA) plays a key role in the pathophysiology of schizophrenia. People with schizophrenia have been shown to possess higher levels of KYNA than healthy individuals. KYNA helps to metabolize tryptophan - an essential amino acid that, in turn, helps the body to produce the "happiness" neurotransmitter serotonin, and the vitamin niacin. (medicalnewstoday.com 9.2.2017).)

(Anm: Psykose. Alle mennesker kan utvikle psykose. - Balansegangen mellom opplevd stress og ballast til å stå imot, er avgjørende, forteller psykiater. (…) - Stress er et sentralt tema. For eksempel har vi forskjellige måter å takle en belastende hendelse på jobb på. (…) - Man kan kalle det en forvirringstilstand, selv om heller ikke det er helt dekkende. (…) Symptomer ved psykose. Tidlige tegn kan være at man: (…) - Det er en kjempebelastning å ha en psykose. Mange blir redde og opplever ting