Legemiddel - pakningsvedlegg (legemiddelinformasjon) (mintankesmie.no)

Norsk pasientskadeerstatning (NPE)

Tidsskrift for erstatningsrett, forsikringsrett og trygderett (idunn.no)

Nekter din lege å erkjenne fakta? (Is Your Doctor in Denial?) (washingtonpost.com 28.8.2007)

Vanskelig å oppnå erstatninger for legemiddelskader i rettssystemet (lakemedelsvarlden.se 11.10.2007)

GlaxoSmithKlines er saksøkt over antidepressivaet Seroxat i England (bloomberg.com 8.1.2008)

Eli Lilly inngår forlik grunnet at de unnlot å advare om at legemidlet Zyprexa kunne forårsake diabetes (Forbes 21.7.2005)

Vant sak mot østrogen-pille

En amerikansk kvinne har fått rettens medhold i at hormonbehandling har skylden for hennes brystkreft. Nå følger tusenvis av liknende rettssaker. (mozon.no 19.10.2006)

Leger: Søksmål bidrar som garantist for legemiddel-sikkerhet (usatoday.com 15.8.2008)

- Undersøkelse viser at leger avviser pasienters klager om bivirkninger

Is Your Doctor in Denial? (Nekter din lege å erkjenne fakta?)
washingtonpost.com 28.8.2007
Undersøkelse viser at leger ofte avviser klager om legemidlers sideeffekter (Survey Finds Physicians Often Dismiss Complaints About Drugs' Side Effects)

Mange engstelige pasienter gir detaljopplysninger på nettforum og pratekanaler på internett om muskelsmerter og hukommelsestap, som de har erfart etter at de begynte med statiner for å senke sitt kolesterol. En ny studie antyder at disse mennesker kanskje har en god grunn til å søke en bekreftelse: Noen klager ville ellers gå upåaktet hen. (On many online message boards and Internet chat rooms, anxious patients share details about the muscle pain and memory loss they have noticed since they started taking statins to lower their cholesterol. A new study suggests these people may be seeking validation for good reason: Some of their complaints might otherwise be going unheard.)

Ifølge en undersøkelse av 650 pasienter publisert sist uke om legemiddelsikkerhet, et fagfellevurdert tidsskrift, ignorerer eller avviser leger ofte pasienters bekymringer om slike sideeffekter. Studien viser et reaksjonsmønster som også gjelder andre legemidler. (According to a survey of 650 patients published last week in Drug Safety, a peer-reviewed journal, doctors frequently ignored or dismissed patients' concerns about such side effects. The study suggests this pattern of reaction goes beyond statins to other drugs.)

Når leger ikke erkjenner pasienters symptomer som en sideeffekt av legemiddelet, er også pasienten utsatt for risiko. På grunn av at legen ikke fyller ut og sender en "bivirkningsrapport" til Food and Drug Administration, kan legemiddelkontrollen undervurdere problemet, og andre leger og pasienter antar at legemiddelet er tryggere enn det er. (When doctors fail to recognize a patient's symptoms as drug side effects, more than that patient's care is put at risk. Because the doctor makes no "adverse event report" to the Food and Drug Administration, the regulatory agency may underestimate the problem, and other doctors and patients may assume the drug is safer than it is.)

Forskerne ved University of California at San Diego gransket sideeffekter for statiner da ble oppmerksomme på problemet. (...) (Researchers from the University of California at San Diego had been investigating the side effects of statins when they noticed the problem.)

Jerry Avorn -- professor ved Harvard Medical School og forfatter av boken "Powerful Medicines: Nytte, risiko og kostnader for reseptbelagte legemidler" -- sa at "der er en skrekkelig underrapportering av sideeffekter," og legger til at 90 til 99% av "alvorlige sideeffekter ikke rapporteres av leger." (...) (Jerry Avorn -- a Harvard Medical School professor and author of the book "Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs" -- said that "there is horrendous underreporting of side effects," adding that 90% to 99% of "serious side effects are not reported by doctors.")

(Anm: Bivirkninger og bivirkningsovervåkning (legemiddelsikkerhet) (mintankesmie.no).)

(Anm: Skader og ulykker i Norge. 2500 dør og 300 000 behandles årlig på sykehus for skader. Mange alvorlige skader er knyttet til alkohol og andre rusmidler, fall og trafikk. (…) Hva er et forgiftningsdødsfall? (fhi.no 14.12.2016).)

(Anm: Medisinske feil — den tredje viktigste dødsårsaken i USA. Hvert år oppstår mer enn 250 000 dødsfall i USA som et resultat av medisinske feil. Medisinske feil inkluderes ikke i dødsattester eller i rangeringen av dødsårsaker. (Medical error—the third leading cause of death in the US.) BMJ 2016;353:i2139 (Published 03 May 2016).)

- GSK dømt til å betale 3 millioner dollar grunnet advokats selvmord i Chicago mens han gikk på generisk Seroxat (Paxil)

GSK told to pay $3M for Chicago attorney's suicide while on generic Paxil
fiercepharma.com 21.4.2017
GlaxoSmithKline came up short in efforts to convince a jury that it shouldn’t be liable for a Chicago lawyer’s 2010 suicide while he was on generic Paxil. On Thursday, jurors sided with the man’s widow, Wendy Dolin, and awarded a $3 million verdict against the drugmaker.

Throughout the trial, Dolin’s attorneys argued that Paxil’s label indicating suicide risks stop at age 24 is flawed, and that Glaxo held a responsibility to inform of the risks. Since generic drugmakers duplicate drug labels for their copycats, Glaxo was at fault in this case, they argued. And the jury agreed.

A spokesperson for GSK said the company is “disappointed” with the verdict and will appeal.

“GSK maintains that because it did not manufacture or market the medicine ingested by Mr. Dolin, it should not be liable,” the company’s spokesperson said. “Additionally, the Paxil label provided complete and adequate warnings during the time period relevant to this lawsuit.”

RELATED: Federal judge declines to toss Paxil suicide case, setting GSK up for September trial

The award fell far short of the $39 million that Dolin's lawyers sought in the case, which turned, in part, on the long debate over whether branded drugmakers should be held responsible in cases where patients took generics. (…)

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

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

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

(Anm: Antipsykotika (psykofarmaka etc.) (mintankesmie.no).)

(Anm: Sovemidler (sovemedisiner) og beroligende midler (mintankesmie.no).)

(Anm: Diskriminering, feilmedisineringer hos mennesker med utviklingshemming og utfordrende atferd (psykofarmaka; antidepressiva, antipsykotika, sovemedisiner) etc. (mintankesmie.no).)

(Anm: På tide å revurdere? (Time to rethink?) Legemiddelbehandlinger hos mennesker med utviklingshemming og utfordrende atferd (Drug treatments in people with intellectual disability and challenging behaviour disabilities) Editorials (Lederartikkel) BMJ 2014;349:g4323 (Published 04 July 2014).)

(Anm: Sovemidler knyttes til dødelighet eller kreft: en matchet kohortstudie. (Hypnotics' association with mortality or cancer: a matched cohort study.)  (...) Målsetting Anslagsvis 6 % -10 % av amerikanske voksne tok et sovemiddel (hypnotika) mot dårlig søvn i 2010. Denne studien underbygger tidligere rapporter som knytter hypnotika (sovemidler) til økt dødelighet. BMJ Open 2012;2:e000850 (27 February).)

(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: US drug regulators should consider adding adults to SSRI suicide warning, says campaigner. A British doctor who campaigned for the public to be warned about increased suicide risk in young people taking antidepressants has said that US drug regulators should consider including adults in warnings. David Healy, a psychiatry professor at Bangor University, called for the warnings after GlaxoSmithKline (GSK) was ordered to pay $3m (£2.34m; €2.75m) to the widow of a US man who killed himself shortly after starting generic paroxetine. (…) When it becomes so clear cut that a jury finds there is a problem, it suggests the evidence is strong enough to look at the issue,” Healy told The BMJ. “If it’s that clear to the average man on the street, and the FDA [the US Food and Drug Administration] doesn’t do something about it, we have an odd situation.” BMJ 2017;357:j2050 (Published 25 April 2017).)

- J&J’s Janssen dømt til å betale 70 millioner dollar i Risperdal-rettssak.

(Anm: J&J’s Janssen dømt til å betale 70 millioner dollar i Risperdal-rettssak. (J&J's Janssen hit with $70 mln verdict in Risperdal trial) (…) Juryen i Philadelphia Court of Common Pleas fant at firmaet mislyktes å advare guttens helsepersonell om risikoen for gynecomastia, som er brystvekst hos menn eller gutter forårsaket av en hormonell ubalanse, og at de med vilje forfalsket, og ødela eller skjulte bevis i saken.) Janssen dømt til å betale 70 millioner dollar i Risperdal-rettssak. (finance.yahoo.com 1.7.2016).)

(Anm: J&J's Janssen hit with $70 million verdict in Risperdal trial. Johnson & Johnson and Janssen are facing more than 12,000 claims over Risperdal, according to Johnson & Johnson's most recent quarterly report. (…) In 2013, Johnson & Johnson and Janssen paid more than $2.2 billion to resolve civil and criminal investigations by the U.S. Department of Justice into its marketing of Risperdal and several other drugs. (reuters.com 1.7.2016).)

(Anm: Jury smacks J&J with $70M in damages in latest Risperdal breast case. Johnson & Johnson ($JNJ) is fighting more than 1,500 legal claims that its antipsychotic Risperdal triggered breast development in boys, and the company has landed on the wrong side of a jury verdict in several of them so far. (fiercepharma.com 5.7.2016).)

- Personskader innen psykiatrien fører sjelden til erstatning.

(Anm: Personskader innen psykiatrien fører sjelden til erstatning. Personskador inom psykiatrin leder sällan till ersättning. (...) Medicineringsskador. Enligt Patientskadelagen kan ersättning bli aktuell endast om förskrivning av läkemedel inte har skett enligt föreskrifter och anvisningar och om de uppkomna besvären har ett samband med sådana brister. (...) Psykofarmaka. Flera psykofarmaka, särskilt vissa antipsykosmedel, ger ibland mycket stor viktuppgång, även åtföljt av diabetes. (...) Tandskador. Flera psykofarmaka ger muntorrhet med ökad risk för tandsjukdomar. Sådana skador ersätts inte genom Patientförsäkringen om förskrivningen skett på ett riktigt sätt. (...) Beroende av bensodiazepiner. Bensodiazepiner förskrivs fortfarande under långa tider på dåligt vetenskapligt underlag. Risken för utveckling av beroende är väl känd. (Läkartidningen 2008;105:39-41 (8.1.2008).)

(Anm: Norsk pasientskadeerstatning (NPE). (mintankesmie.no).)

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

(Anm: Øyesykdommer (øyner er sjelens vindu). (mintankesmie.no).)

- FIKK 2,2 MILL. etter ansiktskramper. (- Kvinnen har fått store skader. I tillegg til de kroniske muskeltrekningene i ansikt, hals og mellomgulv har kvinnen store pustebesvær, sier Svoldal Stæhr i NPE.) (- Det foreligger en potensiell risiko for kramper ved behandling med antidepressive legemidler. (…) - Store smerter. - Kvinnen har store smerter og er delvis eller helt ufør etter å ha tatt preparatet Fontex, sier Svoldal Stæhr.)

(Anm: FIKK 2,2 MILL. etter ansiktskramper. En 51 år gammel kvinne fikk utbetalt hele 2,2 millioner kroner i erstatning, etter at «lykkepiller» ga henne kroniske rykninger i ansiktet. Informasjonssjef Torill Svoldal Stæhr i Norsk pasientskadeerstatning (NPE) ser svært alvorlig på saken. En 51 år gammel kvinne fikk utbetalt hele 2,2 millioner kroner i erstatning, etter at «lykkepiller» ga henne kroniske rykninger i ansiktet. Informasjonssjef Torill Svoldal Stæhr i Norsk pasientskadeerstatning (NPE) ser svært alvorlig på saken. - Kvinnen har fått store skader. I tillegg til de kroniske muskeltrekningene i ansikt, hals og mellomgulv har kvinnen store pustebesvær, sier Svoldal Stæhr i NPE. (…) Fontex, bedre kjent som Prozac, skal virke mot depresjon, angst, spiseforstyrrelser, narkolepsi og andre psykiske lidelser. Det foreligger en potensiell risiko for kramper ved behandling med antidepressive legemidler. (…) - Store smerter. - Kvinnen har store smerter og er delvis eller helt ufør etter å ha tatt preparatet Fontex, sier Svoldal Stæhr. (VG 22.05.2006).)

(Anm: Norsk pasientskadeerstatning (NPE). (mintankesmie.no).)

- Bruk av antidepressiva ble assosiert med et betydelig eldre utseende og forskere fant også ut at vekten spilte en viktig faktor. (- I tillegg mistenker forskerne at den vedvarende avslapping av ansiktsmuskler som antidepressiva forårsaker kan forklare årsaken til at ansiktet faller sammen (henger).)

(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: Legemiddelinduserte mitokondrielle skader og sykdom. (Medication-induced mitochondrial damage and disease.) (mintankesmie.no).)

- Analyse avslører at doseøkning av antidepressiva har ingen nytte. (- Brukere av antidepressiva har høyere dødsrisiko enn ikke-brukere, ifølge forskere.)

(Anm: Brukere av antidepressiva har høyere dødsrisiko enn ikke-brukere, ifølge forskere. (…) Det er imidlertid mindre kjent at alle kroppens store organer - hjertet, nyrene, lungene, leveren - bruker serotonin fra blodstrømmen. (…) Antidepressiva blokkerer også absorpsjonen av serotonin i disse organene, og forskerne advarer mot at antidepressiva kan øke risikoen for død ved å hindre at flere organer fungerer som de skal. Increasing the dosage of antidepressants does not carry benefits, analysis reveals. (…) Authors concluded that according to their findings, dose escalation after initial non-response to standard-dose pharmacotherapy cannot be regarded as general evidence-based treatment option in unipolar depression. (news-medical.net 24.10.2017).)

(Anm: Veteraner som tar PTSD-legemidler dør under søvn (Vets taking PTSD drugs die in sleep) (wvgazette.com 25.5.2008).)

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

(Anm: Antipsykotika (psykofarmaka etc.) (mintankesmie.no).)

(Anm: Sovemidler (sovemedisiner) og beroligende midler (mintankesmie.no).)

- Konklusjoner. Bruk av SSRI var assosiert med vektøkning og forekomst av usunn atferd, inkludert vestlig diett, "sedentarisme" (blir stillesittende/inaktiv) og røyking.

(Anm: Konklusjoner. Bruk av SSRI var assosiert med vektøkning og forekomst av usunn atferd, inkludert vestlig diett, "sedentarisme" (blir stillesittende/inaktiv) og røyking. (Conclusions SSRIs use was associated with weight gain in the presence of unhealthy behaviours including Western diet, sedentarism and smokng. BMJ Open 2017;7:e016224.)

Anm: Antidepressiva (SSRI-er) kan utløse sentral fatigue (sentral utmattelse) (mintankesmie.no).)

– 41 stater sagsøger fem opioid-producenter. Statsadvokaterne i 41 amerikanske stater er gået sammen om at sagsøge fem producenter af de smertestillende midler, der går under fællesbetegnelsen opioider. (- Flere amerikanske stater og amter har igennem længere tid placeret ansvaret hos producenterne, som beskyldes for ikke i tilstrækkelig grad at have oplyst om risikoen for afhængighed og dødsfald ved brug af opioider.)

(Anm: 41 stater sagsøger fem opioid-producenter. Statsadvokaterne i 41 amerikanske stater er gået sammen om at sagsøge fem producenter af de smertestillende midler, der går under fællesbetegnelsen opioider. Har lægemiddelproducenter i deres markedsføring og salg af de smertestillende midler opioider handlet i strid med loven? Det spørgsmål vil 41 amerikanske stater have undersøgt, og de er derfor gået sammen i et fælles søgsmål mod de fem opioid-producenter Endo, Janssen, Teva, Allergan og Purdue. Derudover er tre distributører blevet bedt om at udlevere materiale. Det skriver flere amerikanske medier, heriblandt CNN. Ifølge National Center for Health Statistics døde næsten 35.000 amerikanere i 2015 af en opioid-overdosis, og flere amerikanske stater og amter har igennem længere tid placeret ansvaret hos producenterne, som beskyldes for ikke i tilstrækkelig grad at have oplyst om risikoen for afhængighed og dødsfald ved brug af opioider.Tal fra National Institutes of Health har endvidere vist, at 80 pct. af alle nye heroin-brugere startede med de receptpligtige opioider. Det har fået flere til at proklamere, at landet er midt i en opioid-epidemi, og Præsident Trump kaldte i august situationen for en krise, skriver CNN.Foruden koalitionen af statsadvokater har yderligere syv stater indledt individuelle sager mod en eller flere opioid-producenter. Dermed er 48 af i alt 50 amerikanske stater involveret i retssager mod firmaerne bag de smertestillende midler. (medwatch.dk 30.9.2017).)

(Anm: 41 statsadvokater (påtalemyndigheter) har tatt ut stevning mot opioidprodusenter. 41 state attorneys general subpoena opioid manufacturers. (cnn.com 30.9.2017).)

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

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

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

- Mitokondriell aldring og aldersrelatert mitokondriell dysfunksjon. Alderselaterte endringer i mitokondrier er knyttet til redusert i mitokondriell funksjon. Med fremskyndet aldring reduseres mitokondrielt DNA-volum, integritet og funksjonalitet på grunn av akkumulering av mutasjoner og oksidativ skade fremkalt av reaktive oksygensubstanser (ROS). Hos eldre mennesker er mitokondriene preget av redusert funksjon som redusert oksidativ kapasitet, redusert oksidativ fosforylering, redusert ATP-produksjon, betydelig økning i ROS-generasjon og redusert antioksidantforsvar.

(Anm: Mitokondriell aldring og aldersrelatert mitokondriell dysfunksjon. Abstrakt. Alderselaterte endringer i mitokondrier er knyttet til redusert i mitokondriell funksjon. Med fremskyndet aldring reduseres mitokondrielt DNA-volum, integritet og funksjonalitet på grunn av akkumulering av mutasjoner og oksidativ skade fremkalt av reaktive oksygensubstanser (ROS). Hos eldre mennesker er mitokondriene preget av redusert funksjon som redusert oksidativ kapasitet, redusert oksidativ fosforylering, redusert ATP-produksjon, betydelig økning i ROS-generasjon og redusert antioksidantforsvar. (Abstract Age-related changes in mitochondria are associated with decline in mitochondrial function. With advanced age, mitochondrial DNA volume, integrity and functionality decrease due to accumulation of mutations and oxidative damage induced by reactive oxygen species (ROS). In aged subjects, mitochondria are characterized by impaired function such as lowered oxidative capacity, reduced oxidative phosphorylation, decreased ATP production, significant increase in ROS generation, and diminished antioxidant defense.) Biomed Res Int. 2014;2014:238463. Epub 2014 Apr 10.)

(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: Antipsykotika forårsaker ansiktsgrimasering og andre typer mulige varige hjerneskader (mintankesmie.no).)

(Anm: Lykkepille (Seroxat) utløser tilfeller av aggresjon ("aggression er iagttaget efter markedsføring") (ema.europa.eu 22. januar 2015).)

(Anm: Antidepressiva (SSRI-er) kan utløse sentral fatigue (sentral utmattelse) (mintankesmie.no).)

(Anm: Konklusjoner. Bruk av SSRI var assosiert med vektøkning og forekomst av usunn atferd, inkludert vestlig diett, "sedentarisme" (blir stillesittende/inaktiv) og røyking. (Conclusions SSRIs use was associated with weight gain in the presence of unhealthy behaviours including Western diet, sedentarism and smoking. BMJ Open 2017;7:e016224.)

(Anm: SSRI-preparater og antipsykotika har uheldige effekter på mitokondrier (mintankesmie.no).)

(Anm: Legemiddelindusert kreft og andre typer celleskader (mintankesmie.no).)

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

(Anm: Legemiddelinduserte mitokondrielle skader og sykdom. (Medication-induced mitochondrial damage and disease.) (mintankesmie.no).)

(Anm: Konklusjoner. Bruk av SSRI var assosiert med vektøkning og forekomst av usunn atferd, inkludert vestlig diett, "sedentarisme" (blir stillesittende/inaktiv) og røyking. (Conclusions SSRIs use was associated with weight gain in the presence of unhealthy behaviours including Western diet, sedentarism and smoking. BMJ Open 2017;7:e016224.)

(Anm: SSRI-preparater og antipsykotika har uheldige effekter på mitokondrier (mintankesmie.no).)

(Anm: Legemiddelindusert kreft og andre typer celleskader (mintankesmie.no).)

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

(Anm: Legemiddelinduserte mitokondrielle skader og sykdom. (Medication-induced mitochondrial damage and disease.) (mintankesmie.no).)

(Anm: Sovemidler (sovemedisiner) og beroligende midler (mintankesmie.no).)

(Anm: Sovemidler knyttes til dødelighet eller kreft: en matchet kohortstudie. (Hypnotics' association with mortality or cancer: a matched cohort study.)  (...) Målsetting Anslagsvis 6 % -10 % av amerikanske voksne tok et sovemiddel (hypnotika) mot dårlig søvn i 2010. Denne studien underbygger tidligere rapporter som knytter hypnotika (sovemidler) til økt dødelighet. BMJ Open 2012;2:e000850 (27 February).)

(Anm: - Slår sovepiller os ihjel? (- Studiet er det største af sin slags på globalt plan og har også undersøgt sammenhængen mellem brug af antidepressiver og antipsykotika og dødelighed. Også her fandt forskerne en overdødelighed.) (videnskab.dk 21.3.2016).)

– Antidepressiver fordobler selvmordsrisiko hos barn. Antidepressiver øker risikoen for aggresjon og selvmord hos barn, konkluderer danske forskere. 

(Anm: – Antidepressiver fordobler selvmordsrisiko hos barn. Antidepressiver øker risikoen for aggresjon og selvmord hos barn, konkluderer danske forskere.  Barn og unge har dobbelt så høy risiko for selvmordsatferd når de bruker en av de mest vanlige antidepressive legemidlene, ifølge studien som er publisert i The BMJ i forrige uke. Forskerne har gjort en såkalt metaanalyse, det vil si en systematisk gjennomgang av all tilgjengelig og relevant forskning på området. Forskerne har sett på til sammen 70 forsøk med over 18.000 pasienter der bruk av antidepressiver er sammenlignet med placebo-medisin. (dagensmedisin.no 2.2.2016).)

(Anm: Suicidalitet og aggresjon under behandling med antidepressiva. Alkohol og alvorlige skader under behandling med antidepressiva. Suicidality and aggression during antidepressant treatment. Alcohol and serious harms of antidepressant treatment. BMJ 2016;352:i892 (Published 17 February 2016).)

– Panorama. En forskrivning for mord? (A Prescription for Murder?)

(Anm: Panorama. A Prescription for Murder? Contains some upsetting scenes. Is it possible that a pill prescribed by your doctor can turn you into a killer? Over 40 million prescriptions for SSRI anti-depressants were handed out by doctors last year in the UK. Panorama reveals the devastating side effects on a tiny minority that can lead to psychosis, violence, possibly even murder. With exclusive access to psychiatric reports, court footage and drug company data, reporter Shelley Jofre investigates the mass killings at the 2012 midnight premiere of a Batman movie in Aurora, Colorado. Twenty-four-year-old PhD student James Holmes, who had no record of violence or gun ownership, murdered 12 and injured 70. Did the SSRI anti-depressant he had been prescribed play a part in the killings? Panorama has uncovered other cases of murder and extreme violence which could be linked to psychosis developed after the taking of SSRIs - including a father who strangled his 11-year-old son. Panorama asks if enough is known about this rare side effect, and if doctors are unwittingly prescribing what could be a prescription for murder. (bbc.com 26.7.2017).) (youtube.com)

(Anm: Former FDA head has become “hired gun” for plaintiffs in lawsuits, drug company alleges BMJ 2015;350:h697 (Published 05 February 2015).)

(Anm: - 75 % av heroinbrukerne sier de startet med reseptbelagte opioider (- Opioid, heroindødsfall fortsetter å øke) (medpagetoday.com 1.7.2014).)

(Anm: -  NYU-studie finner at 75 prosent (3/4) av elever på videregående skole (high school) som er heroinbrukere startet med reseptbelagte opioider. (medpagetoday.com 4.12.2015).)

(Anm: Most teens who misuse prescription stimulants say they use other people's medication. Using someone else's medication is the most common form of prescription stimulant misuse among adolescents, according to a University of Florida Health study, which found that 88 percent of teens who used the drugs non-medically in the past 30 days said they had obtained the medications from someone else. (medicalnewstoday.com 4.3.2016).)

(Anm: Lett for unge å kjøpe paracetamol. Til tross for 18 års aldersgrense, selger mange legemidler med paracetamol til mindreårige. Det viser en stikkprøve NRK har gjort. (…) Heller ikke hos apotekene var det vanskelig å kjøpe Paracet, uten samtidig å få den påbudte veiledningen. Tablettene ble solgt uten spørsmål hos alle de 15 apotekene som ble oppsøkt. (nrk.no 17.2.2016).)

(Anm: 50 % av kvinnelige metadonpasienter startet med reseptbelagte smertestillende. (50% of female methadone patients started with prescription painkillers.) (medicalnewstoday.com 10.11.2015).)

- Anklage: Medicinalselskaber skyld i opioid-epidemi. (- J&J kalder anklagerne ”ubegrundede”, mens man hos Purdue deler den officielle bekymring om opioidkrisen. Endo er ikke vendt tilbage på Reuters forespørgsel, mens man hos Teva ikke har ønsket at kommentere sagen.)

Anklage: Medicinalselskaber skyld i opioid-epidemi
medwatch 16.5.2017
Flere medicinalselskaber er nu blevet sagsøgt for at have nedtonet risikoen ved den omdiskuterede smertemedicin opioider. Selskaberne skal holdes ansvarlig for en decideret amerikansk opioid-epidemi, lyder det i anklagen.

En række store medicinalselskaber har nu fået et søgsmål på halsen med en anklage om bevidst at have ført svigagtige markedsføringskampagner med den omstridte smertemedicin opioider. Ifølge Reuters er det Orange County, New York, der har indgivet søgsmålet mod blandt andet Purdue Pharma, Johnson & Johnson, Teva og Endo.

Sagen er den seneste i en række, hvor man på lokalt- og statsniveau søger at holde medicinalselskaberne ansvarlig for den nationale opioid-epidemi, man har oplevet i USA, da smertemidlet er stærkt afhængighedsskabende.

Anklagerne går blandt andet på, at selskaberne gennem vildledende markedsføring har givet et forkert billede af faren ved langtidsbrug af opioider over for læger, farmaceuter og patienter.

Orange County, der har et indbyggertal på 379.000, har registreret 943 opioid-relaterede akutte indlæggelser i 2014 samt 44 dødsfald i 2015 fra overdosis af opioid-smertemedicin.

Steven Neuhaus, direktør i Orange County, siger i en udtalelse, at man har arbejdet sammen med non-profit organisationer og læger for at skabe opmærksomhed omkring opioid-relaterede problemer.”

Men på samme tid ønsker vi, at de ansvarlige kompenserer skatteyderne for de offentlige midler, som amtet har måttet betale for at løse opioidafhængighed,” lød det endvidere.

J&J kalder anklagerne ”ubegrundede”, mens man hos Purdue deler den officielle bekymring om opioidkrisen. Endo er ikke vendt tilbage på Reuters forespørgsel, mens man hos Teva ikke har ønsket at kommentere sagen.

Opioidmisbruget har været stærkt stigende i USA. Det var blandt andet opioider (fentanyl), som tog livet af musikeren Prince sidste år. Ifølge National Center for Health Statistics døde næsten 35.000 amerikanere i 2015 af en opioid-overdosis. I 2005 lå det antal på cirka 15.000 personer. (...)

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

(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: Rusproblem blant eldre. Bruk og misbruk av alkohol og reseptbelagte legemidler er et økende problem blant eldre. Bruk, misbruk eller feilbruk av alkohol og psykofarmaka blant eldre vil komme til å utgjøre en stor folkehelseutfordring, skriver artikkelforfatteren. (dn.no 2.8.2016).)

(Anm: Reseptbelagt misbruk av legemidler i Europa er et større problem enn tidligere antatt. (Prescription drug abuse in Europe is a bigger problem than previously thought.) (medicalnewstoday.com 4.8.2016).)

(Anm: Opioider linket til dødsfall annet enn overdoser, ifølge studie. CHICAGO (AP) — Utilsiktede overdoser er ikke den eneste dødelig risiko ved bruk av kraftige reseptbelagte smertestillende — legemidlene kan også bidra til hjerterelaterte dødsfall og andre dødsfall, antyder ny forskning. (Opioids Linked with Deaths Other than Overdoses, Study Says. CHICAGO (AP) — Accidental overdoses aren't the only deadly risk from using powerful prescription painkillers — the drugs may also contribute to heart-related deaths and other fatalities, new research suggests. (pharmapro.com 15.6.2016).)

(Anm: Chronic opioid use risks increase with knee surgery, cesarean. The study, published in JAMA Internal Medicine, was led by Dr. Eric Sun and co-authored by Prof. Beth Darnall, from the Stanford University School of Medicine in California. According to the Centers for Disease Control and Prevention (CDC), prescription painkillers became more affordable and available in the mid-1990s. Since then, drug overdose rates in the U.S. have more than tripled. Every day, 78 Americans die from an opioid overdose. (medicalnewstoday.com 11.7.2016).)

(Anm: Delirium is associated with 5-fold increased mortality in acute cardiac patients. (medicalnewstoday.com 16.3.2017).)

(Anm: Lager dokumentarfilm om legemiddelindustrien og psykofarmaka. Filmskaper Annikken Hoel vil ha svar på hvorfor søsteren plutselig døde. (Dødsårsak ukjent). (tv.nrk.no/serie/dagsrevyen 13.3.2017).)

(Anm: «Dødsårsak: ukjent»: Bør bli pensum for både leger og lekfolk. Viktig og skremmende om legemiddelindustriens makt. (...) Det er klart at regissøren har en agenda. Hun dveler ikke ved konspirasjonsteorier, men forsøker å finne frem til en sannhet. Det er klart at regissøren har en agenda. Hun dveler ikke ved konspirasjonsteorier, men forsøker å finne frem til en sannhet. Samtidig er mye av informasjonen i filmen kjent dersom du har fulgt med på store søksmål i USA. Hun greier likevel å få frem et oversiktlig og skremmende bilde av de sterke og korrupte båndene som eksisterer mellom politikere, byråkrater og de store farmasøytiske selskapene. (aftenposten.no 22.3.2017).)

(Anm: Norsk dokumentar: «Lykkepillen» Ti år i psykiatrien var som ti år med tortur for Silje Marie. Et møte med en sykepleier endret alt. (aftenposten.no 13.3.2017).)

(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).)

- Medicinalkæmper sagsøges over hjerteproblemer fra diabetesmedicin

Medicinalkæmper sagsøges over hjerteproblemer fra diabetesmedicin
medwatch 10.5.2017
To internationale medicinalselskaber er blevet ramt af 14 søgsmål i USA på baggrund af en forøget risiko for hjertekarproblemer ved brug af et af selskabets lægemidler mod diabetes – en risiko, som de amerikanske lægemiddelmyndigheder advarede om sidste år.

De internationale medicinalkæmper og tidligere partnere på diabetesområdet, AstraZeneca og Bristol-Myers Squibb, bliver nu trukket i retten i USA, hvor man er blevet mødt af 14 søgsmål. (...)

Sagerne relaterer sig alle til diabetesmidlet Onglyza, som de to selskaber udviklede og markedsførte sammen, indtil AstraZeneca overtog partnerens diabetesforretning i slutningen af 2013.

Onglyza tilhører en klasse af diabeteslægemidler kaldet DPP4-hæmmere, som er løbet ind i en række problemer i de senere år og er godt på vej til at blive skubbet i baggrunden af de såkaldte SGLT2-hæmmere og GLP-1-midler.

Salget af Onglyza landede i 2016 på 720 mio. dollars - et fald på 8 pct. i forhold til året før - og i første kvartal i år faldt salget med med 27 pct. til 154 mio. dollars.

Kopier og videresend ikke artiklen. Det er i strid med ophavsretsloven og vores abonnementsbetingelser.

DPP4-hæmmerne er blandt andet blevet kædet sammen med en øget risiko for at patienterne kan udvikle hjertesvigt, og det fik sidste år de amerikanske lægemiddelmyndigheder til formelt at udstede en advarsel om denne alvorlige bivirkning ved brugen af Onglyza. I de 14 sager, som er indgivet til distriktsdomstolen i New Jersey, beskyldes AstraZeneca og BMS for ikke at have advaret patienter om, at Onglyza og kombinationspræparatet Kombiglyza XR kunne føre til hjerteproblemer. (...)

(Anm: Bristol-Myers, AstraZeneca in legal hot seat over Onglyza heart failure warning. (...) The suits, filed in the District of New Jersey, claim the drugmakers failed to warn users that Onglyza and related combo product Kombiglyza XR can cause cardiac arrest, congestive heart failure and death, the New Jersey Law Journal reports. The pharma pair began marketing Onglyza in 2009 before conducting clinical trials to see whether it upped patients’ cardiac risks, the plaintiffs allege, ignoring 2008 FDA guidance that urged companies to “demonstrate that” new therapies “will not result in an unacceptable increase in cardiovascular risk.” (fiercepharma.com 8.5.2017).)

- Flere amerikanske leger anklages for feil bruk av legemidler

More U.S. doctors facing charges over drug abuse (Flere amerikanske leger anklages for feil bruk av legemidler)
reuters.com 14.9.2011
(Reuters) - Michael Jacksons lege anklaget for å ha tatt livet av en popstjerne med en kraftig narkosemiddel, inngår i en liten men voksende antall amerikanske leger som møter rettslige anklager for deres bruk av reseptbelagte legemidler. ((Reuters) - Michael Jackson's doctor, accused of killing the pop star with a powerful anesthetic, has joined a small but growing number of U.S. physicians facing criminal charges over their handling of prescription drugs.)

Medical negligence cases in the United States are typically handled in civil court, with the victim or victim's family seeking money damages from the doctor.
In the case of Jackson's doctor, Conrad Murray, prosecutors allege his negligence was so extreme that he should be charged with involuntary manslaughter and punished with prison time.

Fatal overdoses from prescription painkillers more than tripled to 13,800 in the United States in 1999 through 2006, according to the Centers for Disease Control and Prevention.

Consequently, more doctors are finding themselves in the sights of prosecutors as states like Florida and Georgia confront the growth in abuse of prescription drugs. The prosecution of doctors is seen as more effective than bringing cases against their patients. (...)

(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).)

- Legemiddelindustriens rettslige forlik i 2010 overstiger 4,5 milliarder dollar

Pharma's 2010 legal settlements top $4.5 billion (Legemiddelindustrien rettslige forlik i 2010 overstiger 4,5 milliarder dollar)
fiercepharma.com 23.12.2010
Pharma companies inked settlements of all kinds this year, from deals to resolve off-label marketing investigations to payments in pricing-fraud suits to agreements that ended liability litigation. In fact, drugmakers earmarked more than $4.5 billion to resolve one legal wrangle or another, and at least nine drugmakers were party to those deals.

By our reckoning, GlaxoSmithKline led the settlement tally with more than $2 billion of the total: It settled a host of Avandia liability cases for $460 million, agreed to pay the U.S. government $750 million to settle an investigation into substandard manufacturing, and made a reported $1 billion deal to resolve lawsuits from parents alleging that the antidepressant Paxil caused their children's birth defects. (...)

(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: 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).)

- 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.

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

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

(Anm: Lawsuit vs Pfizer over Celebrex, Bextra safety is revived. April 12 (Reuters) - A federal appeals court on Tuesday revived a long-running class-action lawsuit accusing Pfizer Inc of misleading shareholders about the safety of its Celebrex and Bextra pain-relieving drugs. The 2nd U.S. Circuit Court of Appeals in Manhattan said a lower court judge erred in excluding testimony by Daniel Fischel, a former University of Chicago Law School dean hired as an expert by the shareholders to assess potential damages. (finance.yahoo.com 12.4.2016).)

- Novartis agrees to pay $390m in US kickback case.

U.S. sues Novartis over kickbacks
reuters.com 26.4.2013
(Reuters) - The U.S. government on Friday announced its second civil fraud lawsuit against Novartis AG in four days, accusing a unit of the Swiss drugmaker of paying multimillion-dollar kickbacks to doctors in exchange for prescribing its drugs.

Authorities said the Basel-based company for a decade lavished healthy speaking fees and "opulent" meals, including a nearly $10,000 dinner for three at the Japanese restaurant, Nobu, to induce doctors to prescribe its drugs.

They said this led to the Medicare and Medicaid programs paying millions of dollars in reimbursements based on kickback-tainted claims for medication such as hypertension drugs Lotrel and Valturna and the diabetes drug Starlix.

The charges are detailed in a whistleblower lawsuit first filed against Novartis Pharmaceuticals Corp by a former sales representative in January 2011 and which the U.S. government has now joined. (...)

(Anm: Novartis agrees to pay $390m in US kickback case. Novartis AG, the Swiss drug company, has agreed to pay $390m (£255m; €352m) to settle a lawsuit in which the US government claimed that the company had paid kickbacks to specialty pharmacies to boost sales of its drugs. The lawsuit filed by the US Department of Justice had initially sought $3.35bn in fines and damages, charging that the kickback scheme had led the pharmacies to submit false claims for tens of millions of dollars to Medicare and Medicaid programs. BMJ 2015;351:h5784 (Published 28 October 2015).)

(Anm: Nurofen's maker misled consumers over painkillers' contents, court rules. Drug giant Reckitt Benckiser ordered to pull painkillers off Australian shelves after admitting products marketed for specific types of pain were identical (theguardian.com 14.12.2015).)

(Anm: Australian court orders Nurofen’s specific pain range off the shelves. Reckitt Benckiser (RB), the health and hygiene multinational, has been ordered to recall from Australian stockists a suite of ibuprofen products that claim to relieve specific types of pain after a court found it guilty of misleading and deceptive conduct. BMJ 2015;351:h6852 (Published 16 December 2015).)

- GSK kjemper mot erstatningskrav fra britiske pasienter som tok rosiglitazon (Avandia))

GSK fights compensation claims from UK patients who took rosiglitazone (GSK kjemper mot erstatningskrav fra britiske pasienter som tok rosiglitazon (Avandia))
BMJ 2013;346:f695 (1 February)
Det britiske multinasjonale firmaet SmithKline, som produserer diabeteslegemidlet rosiglitazon (markedsført som Avandia), kjemper mot erstatningskrav fra britiske pasienter som hevder at legemidlet skadet dem, selv om selskapet allerede har betalt milliarder av dollar for å forlike titusenvis av lignende krav i USA. (...) (GlaxoSmithKline, the UK based multinational that makes the antidiabetes drug rosiglitazone (marketed as Avandia), is fighting compensation claims from UK patients who allege that the drug harmed them, even though the company has already paid billions of dollars to settle tens of thousands of similar claims in the United States.)

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

- Pfizer i USA saksøkes av tusenvis (- Ifølge Reuters saksøker nå nær 1000 amerikanske pasienter selskapet)

Pfizer i USA saksøkes av tusenvis
dagensmedisin.no 8.8.2014
1000 pasienter saksøker Pfizer i USA.

Kolesterolmedisinen Lipitor markedsføres av Pfizer, og er et av verdens mestselgende legemidler noensinne. 

Ifølge Reuters saksøker nå nær 1000 amerikanske pasienter selskapet.

Det var i 2012 at amerikanske legemiddelmyndigheter, FDA, advarte om at Lipitor og andre kolesterolsenkende medisiner, såkalte statiner, ble knyttet til hukommelsestap og en mindre forhøyet risiko for å utvikle diabetes.

Pfizer ble deretter saksøkt av flere som mener Pfizer fullt ut har vært klar over disse negative bivirkningene og at selskapet hadde plikt til å informere offentligheten om dette.

Nå er antallet søksmål steget fra 65 til nærmere 1000.

Ifølge Reuters avviser Pfizer beskyldningene. Rettsaken er planlagt i juli neste år. (…)

- Møter tusenvis av Accutane-krav

Facing thousands of Accutane claims, Roche wins appeal of $18M jury verdict Møter tusenvis av Accutane-krav, Roche vinner ankesak på 18 millioner etter jurykjennelse
fiercepharma.com 25.7.2016
Roche won another reprieve in its fight against Accutane safety claims. The Swiss-based drugmaker persuaded a New Jersey appeals court to overturn an $18 million jury verdict in favor of two Accutane plaintiffs.

The Appellate Division ruled Friday that the trial court judge “seriously erred” in allowing some revelations in court while restricting others. The judge’s mistakes were weighty enough to warrant a new trial, the New Jersey Law Journal reports.

It’s the latest in a series of victories on appeal for Roche. Last August, the Appellate Division reversed a $25 million verdict against the company in a similar suit, and in 2014, it reversed a $2.1 million verdict. Back in 2010, the higher court overturned a $10.5 million verdict, sending the case back for retrial.

The lawsuits are among 3,000 assigned to multicounty litigation in New Jersey. The plaintiffs allege that Roche’s acne drug, pulled from the market in 2009, triggered their inflammatory bowel disease.

In addition to the victories at the appellate level, Roche has won two court-level Accutane trials.

"We are very happy that the company has been resolute in defending its medicine and that it has been vindicated for doing so," defense lawyers Paul Schmidt and Michael Imbroscio of Covington & Burling said in a statement to the NJLJ. (…)

(Anm: Accutane (Roaccutane) (isotretinoin) (mintankesmie.no).)

- Mann tilkjent 2,6 millioner dollar i akne-legemiddel-søksmål (Accutane)

Man awarded $2.6 million in acne-medication lawsuit (Mann tilkjent 2,6 millioner dollar i akne-legemiddel-søksmål (Accutane))
pensacolanewsjournal.com 1.6.2007
A New Jersey jury awarded $2.6 million to an Alabama man represented by three local law firms.

The award was based on a civil suit against the makers of an acne medication.

Andy McCarrell said the drug company failed to warn him of the possible side effects of the acne medication Accutane, which led to his development of an inflammatory bowel disease, which was later diagnosed as Crohn's disease.

McCarrell, 36, was represented by Michael Hook and Stephen Bolton of Hook, Bolton, Kirkland & McGhee; Brian Barr of Levin Papantonio; and Nix Daniels and Mary Jane Bass of Beggs & Lane. (...)

(Anm: Accutane (Roaccutane) (isotretinoin) (mintankesmie.no).)

(Anm: Research uncovers bacteria linking Crohn's disease to arthritis. The researchers used fecal samples from patients with IBD to identify bacteria in the gut that were coated with antibodies called immunoglobulin-A (IgA) that fight infection. Using flow cytometry, in which fluorescent probes are used to detect IgA-coated bacterial species, the researchers discovered that IgA-coated E. coli were abundant in fecal samples from patients with both Crohn's disease and spondyloarthritis.  (medicalnewstoday.com 13.2.2017).)

- De fleste rapportene beskriver kjente bivirkninger i hud, muskel og skjelett. Flere rapporter beskriver psykiske bivirkninger og hukommelse - og konsentrasjonsproblemer. 43 % av meldingene gjelder pasienter som har hatt plager i lang tid etter avsluttet Roaccutan-behandling.

Roaccutan (isotretinoin) – Bivirkninger rapportert i Norge
legemiddelverket.no 13.6.2007
(...) De fleste rapportene beskriver kjente bivirkninger i hud, muskel og skjelett. Flere rapporter beskriver psykiske bivirkninger og hukommelse - og konsentrasjonsproblemer. 43 % av meldingene gjelder pasienter som har hatt plager i lang tid etter avsluttet Roaccutan-behandling. Legemiddelverket har mottatt 15 rapporter hvor pasienter har fått gjort en SPECT-undersøkelse (SPECT = Single Photon Emission Computed Tomography) for å se på gjennomblødningen i ulike deler av hjernen. Disse undersøkelsene viste at pasientene hadde sirkulasjonsforstyrrelser i hjernen med redusert eller ujevn blodstrøm. Betydningen av disse rapportene er vurdert av Legemiddelverket i samarbeid med de europeiske legemiddelmyndigheter i 2006. (...)

(Anm: Accutane (Roaccutane) (isotretinoin) (mintankesmie.no).)

(Anm: Research uncovers bacteria linking Crohn's disease to arthritis. The researchers used fecal samples from patients with IBD to identify bacteria in the gut that were coated with antibodies called immunoglobulin-A (IgA) that fight infection. Using flow cytometry, in which fluorescent probes are used to detect IgA-coated bacterial species, the researchers discovered that IgA-coated E. coli were abundant in fecal samples from patients with both Crohn's disease and spondyloarthritis.  (medicalnewstoday.com 13.2.2017).)

- Fransk läkemedelsskandal berör hela Europa

Fransk läkemedelsskandal berör hela Europa
lakemedelsvarlden.se 26.8.2016
Tiotusentals gravida fransyskor har fått läkemedel innehållande valproinsyra, trots risken för fosterskador. Nu förbereder offren en stämning mot tillverkaren Sanofi. (…)

Däremot anges inte hur många barn som kan ha fötts med missbildningar på grund av medicineringen. Siffror från det franska Läkemedelsverket anger dock att 10 procent av de utsatta fostren kan födas med missbildningar och att mellan 30 och 40 procent kan drabbas av utvecklingsstörningar, som autism. (...)

– Den historien berörde framförallt Frankrike. Nu står vi inför ett problem som berör Europa. Och världen, säger Dominique Martin till Europe 1.

När det gäller valproinsyra är Frankrike inte det enda landet som tycks ha reagerat långsamt. Inte förrän i slutet av 2014 beslutade EUs medlemsländer om särskilda regler vid förskrivning av substansen. (…)

(Anm: Valproat eller valproinsyre er en fettsyre som brukes som et antiepileptikum. I tillegg til anfallsforebyggende behandlnig ved epilepsi, brukes legemiddelet ved bipolar lidelse (også behandling av akutt mani) og migrene. Valproat markedsføres i Norge under merkenavnene Orfiril (Desitin Arzneimittel GmbH) og Deprakine (Sanofi-Aventis). (no.wikipedia.org).)

(Anm: Valproate (VPA), and its valproic acid, sodium valproate, and divalproex sodium forms, are medications primarily used to treat epilepsy and bipolar disorder and to prevent migraine headaches.[2] It is useful for the prevention of seizures in those with absence seizures, partial seizures, and generalized seizures. It can be given intravenously or by mouth. Long acting formulations exist.[2] (...) In much of Europe, Depakine and Depakine Chrono (tablets) are equivalent to Epilim and Epilim Chrono above. (en.wikipedia.org).)

- Patienter kan få erstatning, hvis en langvarig behandling med prednisolon har medført knogleskørhed, fordi lægen har glemt at supplere med kalk og D-vitamin

Ny sag om fejlbehandling af 50.000
ekstrabladet.dk 12.11.2010
Patienter kan få erstatning, hvis en langvarig behandling med prednisolon har medført knogleskørhed, fordi lægen har glemt at supplere med kalk og D-vitamin

Danmark er på vej mod en historisk stor sag om forkert behandling af en stor patientgruppe, skriver Dagens Medicin. Det handler om binyrebarkhormonet prednisolon, som nedbryder knoglerne, hvis ikke patienterne får tilskud af kalk og D-vitamin.

Sundhedsstyrelsen har siden 1999 anbefalet, at alle i længerevarende behandling med prednisolon skal knogleskannes og sikres kalk og D-vitamin som supplement. Det er også almen viden for danske læger. Alligevel har lægerne ikke sikret, at en stor patientgruppe har fået kalk og D-vitamin.

50.000 patienter i farezonen
De første 15 patienter har fået tilkendt erstatning på i gennemsnit 440.000 kroner og mange flere kan være på vej. Op mod 50.000 danskere er i en højrisikogruppe, idet de har fået prednisolon i meget lang tid. (...)

(Anm: Prednisolone. Not to be confused with Prednisone. Prednisolone is a synthetic glucocorticoid, a derivative of cortisol, used to treat a variety of inflammatory and autoimmune conditions and some cancers. (en.wikipedia.org).)

(Anm: Alendronate may cut hip fracture risk in older patients taking prednisolone. Older patients who take the anti-inflammatory steroid prednisolone would benefit from treatment with the osteoporosis drug alendronate because it reduces the risk of hip fracture, a retrospective cohort study published in JAMA has found.1 BMJ 2017;358:j3348 (Published 11 July 2017).)

(Anm: Data Lacking on Prednisone Use in RA. Glucocorticoid treatment may be the best and worst possible option. (…) "The medical community has been inept at producing a solid evidence base for the proper application of glucocorticoid therapy," stated Frank Buttgereit, MD, of Charité University Hospital in Berlin, and colleagues. (medpagetoday.com 5.1.2017).)

(Anm: Orale steroider (glukokortikoider) linket til 10 ganger økt risiko for diabetes. (Oral steriods linked with ten-fold increased risk of diabetes. (pulsetoday.co.uk 5.5.2016).)

(Anm: Vanlige legemidler, uvanlig risiko? Høyere frekvens av alvorlige problemer etter kortvarig steroidbruk. (Common drugs, uncommon risks? Higher rate of serious problems after short-term steroid use.) (…) Personer som tok legemidlene var mer sannsynlig å brekke et ben, få en potensielt farlig blodpropp eller få en livstruende sykdom som sepsis i månedene etter deres behandling. (…) Selv om bare en liten prosentandel av begge gruppene kom på sykehus for disse alvorlige helsetruslene, viste det høyere antallet blant mennesker som tok steroider bare noen få dager, at det er grunn til forsiktig og til og med bekymringer, sier forskerne. (news-medical.net 14.4.2017).)

(Anm: Glukokortiokoider. Glukokortikoider har et vidt spekter av forbruksområder; og er uunnværlige i behandlingen av mange alvorlige sykdommer. På folkemunne kalles denne typen medisiner ofte "kortison". Det er egentlig ikke helt riktig. Kortison er riktignok et glukokortikoid, men det finnes også mange andre. Glukokortikoider finnes i: Betametason (Celeston Chronodose®). Deksametason (Decadron®). Metylprednisolon (Depo-Medrol®, Medrol®, Solu-Medrol®). Prednisolon. Prednison. Triamcinolon (Kenacort-T®, Lederspan®). Hydrokortison (Solu-Cortef®). Kortison (Cortison®, Cortone®). Disse preparatene er enten tabletter eller injeksjonsvæske som settes med sprøyte. Glukokortikoider finnes også i en rekke salver, kremer, øyedråper, øredråper, nesesprayer, inhalasjonsprayer og stikkpiller. (lommelegen.no 17.9.2004).)

(Anm: Solu-Medrol 40 mg kan gi alvorlige allergiske reaksjoner hos pasienter med melkeproteinallergi. Legemidler med metylprednisolon til injeksjon som inneholder laktose kan forårsake alvorlige allergiske reaksjoner hos pasienter som er allergiske for melkeproteiner. (legemiddelverket.no 28.8.2017).)

(Anm: Fra Wikipedia, den frie encyklopedi. Inhalasjon av glukokortikoider brukes i behandling av
astma. Glukokortikoider er en klasse steroidhormoner som produseres i binyrebarken, karakterisert ved at de kan binde kortisolreseptorer og dermed gi kortisollignende effekter. Begrepet kortikosteroid omfatter både mineralkortikoider og glukokortikoider, men brukes ofte synonymt med glukokortikoid. Det er utviklet en rekke syntetiske glukokortikoider til bruk som legemiddel ved en rekke tilstander. Populært kalles glukokortikoider ofte Den europeiska läkemedelsmyndigheten EMA har granskat risken för lunginflammation hos KOL-patienter som använder inhalerade kortikosteroider och kan konstatera att risken gäller samtliga läkemedel i denna klass. Det finns inga bevis för några skillnader i risk mellan de olika preparaten. (lakemedelsverket.se 16.5.2016).)

- Beviskravet i vaksineskader etter Rt. 2015 s. 1246

Beviskravet i vaksineskader etter Rt. 2015 s. 1246
Tidsskrift for erstatningsrett, forsikringsrett og trygderett 01 / 2016 (Volum 1)
Sammendrag:  Staten har et rent objektivt ansvar for skader voldt av vaksiner, og det gjelder også en legalpresumsjon i skadelidtes favør, jf. smittevernloven § 8-2 og pasientskadeloven §§ 2 og 3. Hvis vaksinen hadde evne til å volde skaden, presumeres det at vaksinen var årsak til skaden med mindre et annet årsaksalternativ er mer sannsynlig. I Rt. 2015 s. 1246 forstod Høyesterett kravet om årsaksevne slik at det måtte være en «praktisk mulighet» for at vaksinen kunne forårsake sykdommen. Muligheten måtte underbygges med medisinsk forskning, men det krevdes ikke allment akseptert medisinsk forskning. Staten påberopte at skadelidte hadde sykdommen i subklinisk form før vaksinen ble satt, men Høyesterett kom til at det ikke var sannsynlighetsovervekt for dette og la til at en subklinisk tilstand ikke var nok til at en skade forelå. Dommen avklarer viktige spørsmål i vaksinesaker; deler av den er også relevant for andre saker. (…)

(Anm: Norsk pasientskadeerstatning (NPE). (mintankesmie.no).)

(Anm: Gruppesøksmål (massesøksmål) (mintankesmie.no).)

- USA: Kopifirmaer ikke ansvarlige for bivirkninger

Who Is Now Responsible for Discovering and Warning About Adverse Effects of Generic Drugs? (Hvem er nå ansvarlig for å oppdage og varsle om bivirkninger fra generiske legemidler?)
JAMA 2013 (September 11)
When a patient in the United States fills a prescription, the likelihood that a generic drug will be dispensed is overwhelming—and increasing. Generic drugs account for more than 80% of prescriptions, but only 20% of total drug spending, because of their lower cost. The move to generics is estimated to have saved more than a trillion dollars in the last decade.1

Although generic drugs are bioequivalent to their brand-name counterparts, important legal distinctions between the 2 categories have resulted from 3 Supreme Court decisions. The first, Wyeth v Levine, arose after a woman developed gangrene in her forearm caused by intra-arterial injection of Wyeth’s antiemetic Phenergan (promethazine); the patient was awarded $6.7 million in damages based on her claim that the drug’s label did not sufficiently warn about its risks. In 2009, the Court upheld the award, noting that brand-name manufacturers are primarily responsible for providing accurate safety warnings for the drugs they produce.2 The decision makes sense because premarket testing does not reveal the full range of a drug’s adverse effects, postmarket surveillance by the US Food and Drug Administration (FDA) is insufficient, and state tort liability incentivizes manufacturers to continue monitoring the safety of their products. (...)

USA: Kopifirmaer ikke ansvarlige for bivirkninger
medwatch.dk 1.7.2013
Den amerikanske højesteret har besluttet, at patienter ikke kan sagsøge kopivirksomheder pga. bivirkninger fra selskabernes lægemidler, så længe indlægssedlen er identisk med originalproduktets.

I en sag i den amerikanske højesteret er det blevet besluttet, at producenter af generiske lægemidler ikke kan sagsøges pga. bivirkninger, når bare medicinens label, eller indlægsseddel, er en tro kopi af originalproduktets. (...)

Nationale love foreskriver nemlig, at kopivirksomheder skal kopiere indlægssedlen præcist, og det overtrumfer altså en regional lov i staten New Hampshire, som kræver at medicinalselskaber garanterer, at deres lægemidler ikke er ”urimeligt farlige”.

Det mener i hvert fald højesteretten, som med de marginale stemmer 5 mod 4 gav selskabet Mutual Pharmaceutical medhold i den konkrete sag.
Patienten Karen Bartlett havde sagsøgt selskabet pga. alvorlige bivirkninger fra medicinen sulindac – bivirkninger, som der ikke blev advaret om i indlægssedlen. Og selvom en jury i staten havde givet kvinden medhold og tildelt hende 21 mio. dollar i erstatning, har højesteretten altså nu omstødt den beslutning.

Forfærdelig beslutning
Den amerikanske advokat William Havel, som avisen har talt med, kalder beslutningen ”forfærdelig for forbrugere”, som i mange tilfælde ikke længere vil have nogen juridiske muligheder, hvis de oplever problemer med bivirkninger fra lægemidler. Han mener, at kopivirksomhederne ikke længere vil have noget incitament til at ”holde øje med deres lægemidler”.

Han forklarer videre, at mange bivirkninger først bliver opdaget, lang tid efter medicinen er blevet lanceret. Og i nogle tilfælde er originalproduktet måske fjernet fra markedet, hvilket betyder, at kopivirksomheden slet ikke er tvunget til at opdatere indlægssedlen, selvom man senere bliver klar over bivirkninger.

En talskvinde for de amerikanske lægemiddelsmyndigheder, FDA, forklarer ifølge avisen, at man pt. overvejer en ændring af reglerne, så kopivirksomhederne får de samme forpligtelser som originalproducenterne. (...)

Generic drug companies safe from liability suits, Supreme Court rules
cleveland.com 26.6.2013
The U.S. Supreme Court ruled Monday that manufacturers of generic drugs cannot be sued if the labels on their drugs mirror those on the brand-name equivalent. (Associated Press file)

The U.S. Supreme Court ruled this week that makers of generic drugs cannot be sued by patients who experience adverse side effects if the drugs' warning labels copy those on their brand-name counterparts.

The decision could affect millions of Americans, based on U.S. Food and Drug Administration estimates that about three-quarters of prescriptions are for generic drugs, which are cheaper than their brand-name equivalents. (...)

In a 5 to 4 vote on Monday, the court overturned a $21 million jury award to a New Hampshire woman who experienced severe disfigurement and nearly went blind after taking a generic anti-inflammatory drug. Karen Bartlett sued Mutual Pharmaceutical, whose drug sulindac did not specify on its label the side effect that she experienced. (...)

"I would urge consumers to contact the FDA directly and make their concerns known, and perhaps that will allow the FDA to recognize the seriousness of the problem," Hawal said.

On Monday Senate Judiciary Committee Chairman Patrick Leahy, a Vermont Democrat, and six other senators and congressmen sent a letter to the FDA asking that generic drug manufacturers have the same obligation as brand-name companies to provide doctors and patients with updated safety information and to be held accountable if they neglect to do so.

"We are looking at regulatory changes," Sandy Walsh, a spokeswoman for the FDA, said Wednesday. "The discussions are underway." (...)

- Milliardkrav mod J&J for at skjule bivirkninger på antibiotika. (- Udover J&J er den tidligere FDA-kommisær Margaret Hamburg også blevet sagsøgt af de fem personer.)

Milliardkrav mod J&J for at skjule bivirkninger på antibiotika
medwatch.dk 22.1.2016
Amerikanske Johnson & Johnson må føje endnu et søgsmål til puljen om skjulte bivirkninger ved brugen af antibiotikummet Levaquin. Kravet fra sagsøgerne lyder denne gang på næsten 6 mia. kr.

Fem personer har rejst et milliardkrav mod amerikanske Johnson & Johnson, fordi de mener, at medicinalselskabet bevidst har skjult en række alvorlige bivirkninger ved brugen af antibiotikummet Levaquin. Det skriver FierceBiotech.

Sagsøgerne mener, at J&J og Janssen har fejlmærket og fejlbranded Levaquin, der bliver brugt til behandling af bronkitis, lungebetændelse, klamydia, gonoré og hudinfektioner, ved at nedtone skadelige bivirkninger for deres egen økonomiske gevinst.

Udover J&J er den tidligere FDA-kommisær Margaret Hamburg også blevet sagsøgt af de fem personer, der har rejst et krav om 120 mio. dollars, svarende til 822 mio. kr. i kompenserende erstatning, og 750 mio. dollars, 5,1 mia. kr., som straffende erstatning for "alvoren af deres ekstreme adfærd og afskrække lignende adfærd i fremtiden."

Det er ikke første gang, at Levaquin er omdrejningspunkt i juridiske tvister. Ifølge FierceBioteh har J&J haft tusindvis af søgsmål over de seneste år fra sagsøgere, der hævder, at man ikke tilstrækkeligt har advaret patienterne om faren ved lægemidlet. (…)

(Anm: J&J idømt millionerstatning i talkum-sag. Johnson & Johnson er blevet idømt at betale en trecifret millionerstatning, efter en kvinde døde af kræft i æggestokkene, som er blevet koblet til brugen af J&J's babypudder. Familien til en kvinde, der sidste år døde af kræft i æggestokkene, er nu blevet tildelt en trecifret millionerstatning af Johnson & Johnson. Ifølge Bloomberg skal J&J betale 10 mio. dollars som en kompensation og 62 mio. dollars som et "straffetillæg." (dagenspharma.dk 23.2.2016).)

(Anm: J&J vil ikke give op i talkum-sag. Amerikanske Johnson & Johnson står fast på, at der ikke er noget galt med deres talkum, selvom over 1.400 kvinder sagsøger selskabet, og selskabet allerede har tabt tre retssager. (medwatch.dk 23.5.2016).)

(Anm: Johnson & Johnson dømt til å betale 72 millioner dollar. Det farmasøytiske selskapet Johnson & Johnson er dømt til å betale erstatning til familien til en avdød kvinne som hevdet at talkum ga henne kreft. (…) rettssaken viste Fox sine advokater til et internt notat fra september 1997 hvor en medisinsk konsulent hos Johnson & Johnson skriver at enhver som benekter risikoen mellom hygienisk talkumbruk og eggstokkreft vil offentlig bli oppfattet på samme måte som de som nektet en sammenheng mellom røyking av sigaretter og kreft. (nrk.no 24.2.2016).)

- Flere pasienter enn normalt får betennnelse eller kreft i bukspytkjertelen?

EU regulator finds no new safety issues with diabetes drugs (EU-tilsyn finner ingen nye sikkerhetsspørsmål ved diabetesmedisiner)
reuters.com 27.7.2013
(Reuters) - European drugs regulators have found no new safety concerns with diabetes drugs known as GLP-1 and DPP-4 therapies after concluding a safety review of possible links to damage to the pancreas.

The class of drugs - known as glucagon-like-peptide-1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors - includes Merck's $4 billion-a-year Januvia franchise, Novo Nordisk's Victoza, and Byetta and Onglyza from Bristol-Myers Squibb and AstraZeneca, among others.

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use reviewed the medicines after a study suggested they may increase the risk of pancreatitis, or inflammation of the pancreas, and cellular changes called pancreatic-duct metaplasia in patients with type 2 diabetes.
The U.S. Food and Drug Administration (FDA) said in March it was also studying the drugs' safety.

But the EMA said on Friday said that after a review of all available non-clinical and clinical data, "there is no change in evidence regarding the risks of pancreatic adverse events".

The EMA said its experts had reviewed the study itself and found "a number of methodological limitations and potential sources of bias" which it said "preclude a meaningful interpretation of the results".

More than 370 million people are living with diabetes worldwide, with type 2 accounting for 90 percent to 95 percent of the cases, according to the International Diabetes Federation. (...)

(Anm: Legemiddelindusert kreft og andre typer celleskader (mintankesmie.no).)

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

(Anm: Pancreatic cancer risk linked to changes in mouth bacteria. The presence of certain bacteria in the mouth may indicate a raised risk for pancreatic cancer - a disease that often begins with no symptoms and for which there is no routine screening test. (…) The researchers suggest the finding may lead to earlier, more precise treatments for pancreatic cancer, a disease with a pitifully low survival rate as it often escapes early diagnosis. (medicalnewstoday.com 20.4.2016).)

(Anm: Pancreatitis often caused by gallstones - also statins increase risk. Idiopathic pancreatitis is often caused by small gallstones that are difficult to observe prior to surgery, shows a study from the University of Eastern Finland. Small gallstones were found in surgery from two out of three idiopathic pancreatitis patients. The study also showed that acute pancreatitis was more common in statin users than non-users. (medicalnewstoday.com 7.12.2015).)

(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].)

Incretin therapy: should adverse consequences have been anticipated? (Inkretin-terapi: burde uheldige konsekvenser vært forventet?)
Editorial
BMJ 2013;346:f3617 (10 June 2013)
Åpenhet er det vi trenger (Transparency is what we need)

In a linked investigation (doi:10.1136/bmj.f3680), Cohen shines a spotlight on the safety of the incretins—drugs for the treatment of diabetes that mimic or enhance the biological effects of glucagon-like peptide-1 (GLP-1).1 Her investigation raises important questions as to the nature of the dialogue between drug companies and the regulators, and the extent to which potentially harmful effects of these drugs have been hidden from prescribers and patients.

The drugs that have transformed the modern treatment of chronic illness—β blockers, angiotensin converting enzyme inhibitors, and statins—are typically inhibitors of defined molecular pathways, with consequences that are relatively predictable. By contrast, the incretins are agonists that act on multiple targets with multiple effects. They are “magic shotguns” rather than “magic bullets.”

The thiazolidinediones—nuclear receptor agonists that modulate the activity of numerous genes—are good examples of this. They were introduced with great fanfare, but unwanted effects such as weight gain, fluid retention, and osteopenia have limited their use in the management of diabetes. Troglitazone, the first in class, was withdrawn because of hepatic injury; rosiglitazone was withdrawn from most countries in 2011 because of cardiovascular problems; and pioglitazone has been implicated in bladder cancer. (...)

(Anm: Incretin based drugs and the risk of pancreatic cancer: international multicentre cohort study.  BMJ 2016;352:i581 (Published 17 February 2016).)

(Anm: Editorials. The safety of incretin based drug treatments for type 2 diabetes. Latest data are reassuring about pancreatic cancer, less so about heart failure. The incretin based drugs (dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagon-like peptide-1 receptor agonists) are one of several options for glucose lowering in people with type 2 diabetes who are already taking (or unable to take) metformin.1 As with other antidiabetic drugs, the long term safety of these drugs remains unclear. Studies by Azoulay and colleagues (doi:10.1136/bmj.i581) and Li and colleagues (doi:10.1136/bmj.i610) in this issue provide updated evidence about incretin based treatments and the risk of pancreatic cancer and heart failure.  BMJ 2016;352:i801 (Published 17 February 2016).)

Helping patients make sense of the risks of taking GLP-1 agonists
Editorial
BMJ 2013;346:f3692 (10 June 2013)
There are three reasons to lower glycaemia in patients with type 2 diabetes: to treat the symptoms of hyperglycaemia; to prevent symptomatic hyperglycaemia; and to reduce the risk of developing complications associated with diabetes. Regulatory agencies approve antihyperglycaemic agents because they prevent and treat hyperglycaemia. The US Food and Drug Administration now requires drug companies to show that their antihyperglycaemic drugs do not increase a patient’s risk of developing cardiovascular disease. Currently, however, no regulatory agency requires evidence of a drug’s efficacy in reducing the risk of developing complications of diabetes. (...)

(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].)

Novo-medicin måske kræft-fremkaldende - myndighederne tøver med at gribe ind
bt.dk 9.6.2013
Det er Novo Nordisks nye lægemiddel mod type 2-diabetes, Victoza, der er under mistanke for at være kræft-fremkaldende.

Forskere er blevet kritiseret for at have offentliggjort analyser af offentlige databaser over bivirkninger, som viste advarselssignaler om kræft ved diabetes-medicin. Nu bekræfter myndighederne, at signalet er der, men at det ikke er nok til at gribe ind.

De amerikanske og europæiske lægemiddelmyndigheder erkender nu for første gang åbent, at deres analyser af bivirknings-rapporter indeholder et advarselssignal om kræft ved Novo Nordisks blodsukker-sænkende medicin Victoza og andre af verdens bedst sælgende diabetes-midler.

Det drejer sig om den sjældne, men alvorlige og svært helbredelige bugspytkirtel-kræft, som er overrepræsenteret i myndighedernes bivirknings-databaser. Advarselstegnet har været diskuteret i kulissen gennem længere tid. (...)

Amerikanske advokater lugter blod i Victoza-sag
medwatch.dk 7.6.2013
Texas-advokater går nu direkte efter massesøgsmål mod bl.a. Novo Nordisk i sag om diabetesmidlet Victoza.

De amerikanske advokater med medicinalsektoren som speciale i firmaet Watts Guerra, Texas, lugter nu blod og går efter Novo Nordisk. Det sker bl.a. ved på en hjemmeside at opfordre patienter, der tager Victoza, til at henvende sig med henblik på massesøgsmål.

Når det bl.a. er det danske selskab, advokaterne har fået færten af, skyldes det den om-sig-gribende debat om risikoen for bugspytkirtelbetændelse og bugspytkirtelkræft ved de storsælgende diabetesmidler, de såkaldte hormon-analoger, kaldet GLP1-analoger. Victoza tilhører den klasse.

De ligner et naturligt hormon og sikrer dels, at blodsukkeret falder og dels, at appetitten hæmmes. Det er positivt, da de fleste type 2-diabetikere er meget overvægtige. Og GLP1-analogen er netop til patienter, hvor et vægttab er centralt i behandlingen. Victoza gives som injektioner under huden. (...)

USA skærper advarsel på Novos store håb
business.dk 16.5.2013
De amerikanske myndigheder skriver nu for første gang, at der er observeret alvorlige tilfælde af betændelse i bugspytkirtlen hos patienter, som har fået Victoza. Men det er bare noget, de siger for at holde deres egen og industriens ryg fri, siger Novo-chef.

Novo Nordisks milliardsælgende diabetesmiddel Victoza har fået opdateret sin indlægsseddel i USA med informationer om, at der er observeret alvorlige tilfælde af betændelse i bugspytkirtlen hos patienter, som har fået Victoza.

Under sektionen "advarsler og forholdsregler" har de amerikanske myndigheder tilføjet følgende: "Baseret på spontane postmarketing rapporter, er akut pancreatitis (betændelse i bugspytkirtlen, red.), herunder fatal og ikke-fatal blødende eller vævsødelæggende pancreatitis, blevet observeret hos patienter behandlet med Victoza." (...)

I øjeblikket diskuteres det intensivt, om Victoza og de øvrige lægemidler rent faktisk er årsag til, at flere patienter end normalt får betændelse eller kræft i bugspytkirtlen. Det sker på baggrund af flere amerikanske studier og analyser, som antyder en sammenhæng; undersøgelser der dog ikke har involveret Victoza. Samtidig har amerikanske patienter indledt en række erstatningssager mod blandt andre Novo Nordisk, fordi de mener, at de har fået kræft i bugspytkirtlen efter at være behandlet med Victoza eller et af de andre lægemidler i klassen.

Novo Nordisk afviser pure enhver sammenhæng, lige som selskabet ikke mener, at der er noget af komme efter i retssagerne. Det sker med henvisning til, at selskabet ikke har set signaler på en sammenhæng i de mere end 1,2 millioner patient års behandling, som selskabet indtil nu har behandlet. (...)

(Anm: Victoza-sager om produktansvar afvises i USA. Medicinal & Biotek:   Novo Nordisk og en række andre medicinalselskaber har formået at få en stribe produktansvarssager afvist i USA. En dommer ved en føderal domstol har ifølge National Law Journal mandag afvist i alt 750 sager, der handlede om erstatning for kræft i bugspytkirtlen i forbindelse med brug af inkretinbaserede diabetesmidler, heriblandt Novos diabetesmedicin Victoza. (…) Men det skal siges, at sagsøgerne har en appelmulighed, så vi må lige se, om de vil benytte sig af den," siger kommunikationschef i Novo Nordisk Mike Rulis til Ritzau Finans. (medwatch.dk 13.11.2015).)

(Anm: Pancreatic cancer risk linked to changes in mouth bacteria. The presence of certain bacteria in the mouth may indicate a raised risk for pancreatic cancer - a disease that often begins with no symptoms and for which there is no routine screening test. (…) The researchers suggest the finding may lead to earlier, more precise treatments for pancreatic cancer, a disease with a pitifully low survival rate as it often escapes early diagnosis. (medicalnewstoday.com 20.4.2016).)

(Anm: Pancreatitis often caused by gallstones - also statins increase risk. Idiopathic pancreatitis is often caused by small gallstones that are difficult to observe prior to surgery, shows a study from the University of Eastern Finland. Small gallstones were found in surgery from two out of three idiopathic pancreatitis patients. The study also showed that acute pancreatitis was more common in statin users than non-users. (medicalnewstoday.com 7.12.2015).)

Små gnavere sætter kæp i Novo-hjulet
business.dk 3.4.2009
Der er gået mus og rotter i Novo Nordisks store satsning, Victoza. Øget forekomst af den sjældne c-cellekræft i skjoldbrugskirtlen hos mus og rotter i de dyreforsøg, som Novo Nordisk har foretaget med Victoza, ser ud til at sætte grus i Novos ellers velsmurte maskineri. (...)

Risiko for kræft
Betænkelighederne går først og fremmest på, om langtidsbrug af Victoza kan føre til kræft i skjoldbrugskirtlen. Ved dyreforsøg med mus og rotter har Novo Nordisks forskere nemlig fundet en øget forekomst af blandt andet såkaldt c-celle skjoldbrugskirtelkræft hos rotter og mus af såvel han- som hunkøn. Mens det ikke er så usædvanligt at finde denne type celleforandringer hos rotter, er det meget sjældent hos mus. (...)

Novo-guldfugl sagsøges for kræft i USA
business.dk 2.5.2013
Novo Nordisk bliver afkrævet erstatning for kræft i bugspytkirtlen hos amerikanske patienter, der har fået ordineret Victoza og andre lignende medicinprodukter. Novo afviser anklagen. (...)

Én af dem er Novo Nordisks guldfugl Victoza, der over de seneste 12 måneder har solgt for mere end ti milliarder kr. på globalt plan.

Ifølge Berlingske Business oplysninger er Novo Nordisks amerikanske konkurrent Eli Lilly også involveret i retssagerne. Lilly havde indtil for nylig haft markedsføringsrettighederne over Victoza-konkurrenten Byetta.

Ligeledes er amerikanske Merck involveret. Selskabet markedsføre det populære diabetesmiddel Januvia.

Mens de øvrige selskaber er sagsøgt for, at deres lægemidler har givet patienterne enten betændelse eller kræft i bugspytkirtlen, er Novo Nordisk kun sagsøgt for kræft i bugspytkirtlen. (...)

Novo: Ingen kræftrisiko ved diabetesmiddel
medwatch.dk 2.5.2013
Forskningsdirektør i Novo Nordisk afslører, at dugfriske, foreløbige data afviser flere påstande om øget kræftrisiko ved Victoza.

Det bedste forsvar er som bekendt angreb. Og nu forsøger Novo Nordisk at tage teten i forhold til den seneste tids spekulationer om, hvorvidt diabeteslægemiddelklassen GLP-1-analoger, som milliardsællerten Victoza tilhører, giver en forøget risiko for kræft eller betændelse i bugspytkirtlen.

Der er tale om en foreløbig databaseanalyse, som Novo Nordisk er blevet pålagt at gennemføre af de amerikanske myndigheder ved godkendelsen af Victoza, og som forskningsdirektør Mads Krogsgaard Thomsen ifølge Berlingske Business præsenterer på det roadshow, som han og resten af ledelsen i øjeblikket er på i forbindelse med selskabets kvartalsregnskab. (...)

(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].)

- FDA-analyse viste øget dødelighed ved brug af Onglyza, men et rådgivende panel anbefaler nu, at risikoprofilen angives til at være acceptabel.

Rådgivere blåstempler Onglyza overfor FDA
dagenspharma.dk 16.4.2015
FDA-analyse viste øget dødelighed ved brug af Onglyza, men et rådgivende panel anbefaler nu, at risikoprofilen angives til at være acceptabel.

AstraZeneca DPP4-hæmmere FDA Onglyza Type 2 diabetes

Et flertal i et rådgivende panel under den amerikanske lægemiddelmyndighed FDA besluttede i går, tirsdag, at sikkerheden ved brug af lægemidlet Onglyza (saxagliptin) til behandling af patienter med type 2-diabetes er acceptabel. Det rådgivende panel, Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC), mødtes få dage efter, at FDA i fredags udsendte en rapport, som viser, […]

(Anm: Onglyza (Saksagliptin; saxagliptin) (felleskatalogene.no).)

(Anm: Onglyza (Saksagliptin; saxagliptin) (dailymed.nlm.nih.gov).)

(Anm: Diabetes drugs fuel cancer spread in mouse study. (…) When scientists exposed lab dishes of human cancer cells (liver, breast, colon, ovarian) to the diabetes drugs sitagliptin (sold by Merck as Januvia) and saxagliptin (AstraZeneca’s Onglyza), the cells migrated more. And when nine mice with human tumors were given either of the drugs, the cells metastasized more and invaded far-flung tissue, said senior author Hongting Zheng, an endocrinologist at Third Military Medical University in Chongqing, China. The drugs did not raise the risk of developing cancer. (statnews.com 14.4.2016).)

(Anm: FDA warns on heart failure risk associated with Onglyza, Nesina. The FDA is adding new warnings to the labels for AstraZeneca's Onglyza (saxagliptin) and Takeda's Nesina (alogliptin) after an internal safety review found an increased risk of heart failure with the two diabetes drugs. The move comes after the FDA reviewed two studies of the drugs. In a study involving 16,492 patients with Type 2 diabetes, 3.5% of Onglyza-treated patients were hospitalized for heart failure versus 2.8% of placebo-treated patients. The second study involved 5,380 patients, and among this group, 3.9% of Nesina-treated patients were hospitalized compared to 3.3% of placebo-treated patients. (biopharmadive.com 6.4.2016).)

- Vanskelig å oppnå erstatninger for legemiddelskader i rettssystemet?

15 patienter får erstatning for behandling med gigtmedicin
dagenspharma.dk 22.10.2013
Patientforsikringen har udbetalt 7,4 mio. kr. i erstatninger i forbindelse med behandling med Cox-2-hæmmere. (...)

(Anm: Vioxx - informasjon vs kunnskap og visdom - hvem visste hva? (mintankesmie.no).)

Trial against epilepsy drug manufacturer collapses after legal aid is withdrawn (Rettssak mot produsent av epilepsilegemiddel kollapser etter at rettshjelp er trukket)
BMJ 2010; 341:c6384 (10 November)
A High Court action against the multinational drug company Sanofi-Aventis over birth defects in children whose mothers took its anticonvulsant drug sodium valproate (marketed as Epilim) during pregnancy has collapsed just days before trial after legal aid was withdrawn.

The Legal Services Commission for England and Wales is thought to have spent around £3m (€3.5m; $4.8m) over six years funding the case, brought by around 80 families, but has refused funding for the trial, which was due to start on 15 November at the High Court in London.

David Body, head of medical law at the solicitors firm Irwin Mitchell, which acts for the families, said that the withdrawal of funds was “bitterly disappointing” for them. “Without public funding to support the case against this multinational pharmaceutical company, it seems very likely that this claim will have to be discontinued.” (...)

(Anm: Sakkyndige legers integritet, partiskhet og habilitet versus løgn i rettssalen (sakkyndighet) (mintankesmie.no).)

Overøst med piller - får erstatning
nrk.no 8.6.2010
En Vinstra-mann som fikk 35.000 piller på fire år av fastlegen sin, får nå erstatning.

Den 56 år gamle mannen jubler etter lang tids kamp, skriver VG i dag.

I en fire års periode fikk 56-åringen tusenvis av smertestillende tabletter av fastlegen sin. Han havnet ofte på sykehuset i Lillehammer på grunn av overdoser, skriver VG.

I løpet av de fire årene fikk han i alt 19.200 Paralgin forte, 9440 Somdril, 11.700 Stesolid og nesten 6000 Tramadol. (...)

Australian court findings on Vioxx may have global ramifications (Australsk retts kjennelse angående Vioxx kan få globale følger)
BMJ 2010;340:c1485 (16 March)
A court in Melbourne has ruled that the anti-arthritis drug rofecoxib (Vioxx) increased the risk of heart attack, while finding that the Australian subsidiary of its manufacturer engaged in negligent and misleading behaviour.

In a class action judgment delivered earlier this month, the federal court judge Christopher Jessup found that rofecoxib contributed to the heart attack of plaintiff Graeme Peterson.

The judge ruled that Merck Sharp & Dohme "fell short" of what was required in the reasonable discharge of its "duty of care" by failing to warn Mr Peterson’s doctor of the drug’s potential cardiac risk and because sales representatives overemphasised its safety. (...)

Vioxx-sagen
gigtforeningen.dk 5.11.2008
(...) Gennem de seneste år har Gigtforeningen været i kontakt med en lang række af de mange danskere, der nåede at blive behandlet med gigtmedicinen Vioxx, inden det blev taget af markedet på grund af alvorlige bivirkninger. I Danmark har 108 anlagt erstatningssag mod det amerikanske medicinalvarefirma, og dommene er nu begyndt at falde. De fleste patienter får afslag. (...)

(Anm: Medicin (gigtforeningen.dk).)

Få Vioxx-patienter får ersättning
lakemedelsvarlden.se 11.10.2007
Endast nio personer har hittills fått ersättning från Läkemedelsförsäkringen på grund av smärtläkemedlet Vioxx. För 108 personer anser försäkringen inte att sambandet mellan läkemedlet och sjukdom är klarlagt. (...)

I USA pågår flera rättegångar mot det amerikanska företaget Merck som sålde Vioxx. Enligt en artikel i New York Times från augusti i år har 45 000 personer stämt företaget i USA, men hittills har ingen person fått några pengar av företaget. (...)

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

(Anm: VG: Norske dommere omgår loven - dropper å registrere egne aksjekjøp (dn.no 5.9.2016).)

(Anm: Én av 25 sier de har betalt bestikkelser til norsk rettsvesen. (nettavisen.no 10.7.2013).)

(Anm: - Tar ikke økonomisk kriminalitet på alvor (e24.no 18.11.2013 ).)

- Merck har brukt mer enn 1 milliard dollar på saksomkostninger for å bekjempe krav fra skadede pasienter

Plaintiffs Find Payday Elusive in Vioxx Cases
nytimes.com 21.8.2007
KEENE, Tex. — In Carol Ernst’s eyes, two years ago she won a measure of justice. (...)

But her comfort was premature. Merck, the third-largest American drug maker, appealed the verdict — which Texas laws on punitive damages automatically reduced to $26.1 million. Until higher courts rule on the appeal, Merck is not obligated to pay. So Mrs. Ernst, 62, has yet to receive any money.

In fact, none of the 45,000 people who have sued Merck, contending that they or their loved ones suffered heart attacks or strokes after taking Vioxx, have received payments from the company. The lawsuits continue, for now in a state of legal limbo, with little prospect of resolution.

In combating the litigation, Merck has made an aggressive, and so far successful, bet that forcing plaintiffs to trial will reduce the number of Vioxx lawsuits and, ultimately, its liability.

Promising to contest every case, Merck has spent more than $1 billion over the last three years in legal fees. It has refused, at least publicly, to consider even the possibility of an overall settlement to resolve all the lawsuits at once. (...)

(Anm: Vioxx - informasjon vs kunnskap og visdom - hvem visste hva? (mintankesmie.no).)

- GlaxoSmithKlines er saksøkt over antidepressivaet Seroxat

Paxil Plaintiff Settles Birth Defects Lawsuit (Seroxat-saksøker forliker fødselsdefekt-søksmålsøksmål)
lawyersandsettlements.com 20.10.2010
Watertown, SD: A woman who recently settled her Paxil birth defects lawsuit ended a legal ordeal that began with the 2004 death of her newborn son. The woman's Paxil lawsuit alleged her son suffered from Paxil birth defects, including persistent pulmonary hypertension of the newborn (PPHN). (...)

READ MORE [ PAXIL ARTICLES ] (...)

(Anm: Does SSRI Use During Pregnancy Increase the Risk for PPHN? Yes, though perhaps more modestly than previously suggested. (…) Comment This is the most comprehensive analysis to date of the relationship between SSRI use and PPHN in the U.S. Although questions remain about whether SSRI use is associated with milder versus severe PPHN, this is the first study to rigorously control for maternal depression and provides important data indicating that the overall risk for PPHN following maternal SSRI use might be more modest than previously described. NEJM 2015 (July 13, 2015).)

Glaxo Said to Have Paid $1 Billion in Paxil Suits (Update2) (Glaxo hevdes å ha betalt 1 milliard dollar i forbindelse med Seroxat-søksmål)
Bloomberg.com 14.12.2009
Dec. 14 (Bloomberg) -- GlaxoSmithKline Plc has paid almost $1 billion to resolve lawsuits over Paxil since it introduced the antidepressant in 1993, including about $390 million for suicides or attempted suicides said to be linked to the drug, according to court records and people familiar with the cases.

As part of the total, Glaxo, the U.K.’s largest drugmaker, so far has paid $200 million to settle Paxil addiction and birth-defect cases and $400 million to end antitrust, fraud and design claims, according to the people and court records.

The $1 billion “would be worse than many people are expecting,” said Navid Malik, an analyst at Matrix Corporate Capital in London. “I don’t think this is within the boundaries of current assumptions for analysts.” (...)

GlaxoSmithKline Reportedly Paid $1 Billion for Paxil Lawsuits (GlaxoSmithKline har angivelig betalt én milliard dollar for Seroxat-søksmål)
lawyersandsettlements.com 14.12.2009
Philadelphia, PA: According to reports, Paxil-maker GlaxoSmithKline may have paid almost $1 billion to settle Paxil lawsuits alleging serious side effects, including birth defects, addiction and suicides or attempted suicides. (...)

With 600 birth defects lawsuits still waiting in the wings, a $2.5 million settlement for each lawsuit could leave GlaxoSmithKline on the hook for $1.5 billion in birth defect lawsuits alone.

According to Bloomberg, approximately 150 suicide-related lawsuits were settled for an average of $2 million and 300 suicide attempt cases were settled for an average of $300,000. Meanwhile, 10 birth defect lawsuits were settled for an average of $4 million. (...)

GSK paid $1billion to dismiss legal claims (GSK betalte 1 milliard dollar for å forlike rettslige krav)
dailymail.co.uk 14.12.2009
Glaxosmithkline has paid almost $1billion (£614million) to settle American legal claims linked to its controversial antidepressant Seroxat, it emerged yesterday.

The figure includes $390million used to 'resolve' court action linked to suicide and attempted suicide.

The financial data group Bloomberg trawled court records and the company's financial reports going back many years, as well as speaking to people close to the Seroxat cases. (...)

Glaxo Ordered to Pay $2.5 Million for Paxil Defects (Update3)
(Glaxo dømt til å betale 2,5 millioner dollar for Seroxat-fødselsskader)
Bloomberg.com 13.10.2009
Oct. 13 (Bloomberg) -- GlaxoSmithKline Plc must pay $2.5 million over claims that its Paxil antidepressant caused birth defects, a Pennsylvania jury concluded in the first of 600 such cases to come to trial. (...)

GSK to Pay $2.5 Million to Family in Birth Defects Lawsuit (GSK betaler 2,5 millioner dollar til familie for Seroxat-fødselsdefekter)
lawyersandsettlements.com 13.10.2009
(...) Interne GSK-e-poster indikerer at de visste (Internal GSK Emails Suggest They Knew)

Under rettssaken ba dommeren GSK om å overlevere e-poster skrevet av GSK-ledere, og en slik e-post, et notat skrevet av Bonnie Rossello i 1997, som var spesielt belastende, inneholdt uttalelsen, "Dersom negative, resultater kan begraves." Rosello refererte til hva den farmasøytiske giganten burde gjøre dersom det ble nødvendig å utføre dyrestudier på Seroxat (Paxil), kjent som paroxetine (paroksetin). Ifølge resultater utført av danske utviklere av den kjemiske forbindelsen, tok lave doser av paroxetine livet av unge rotter. (During the court case the judge ordered GSK to hand over emails written by GSK executives, and one such email, written by Bonnie Rossello in a 1997 memo, was particularly incriminating, including the statement, "If neg, results can bury." Rosello was referring to what action the pharmaceutical giant should take if it became necessary to do animal studies with Paxil, known generically as paroxetine. According to results of a study done by the Danish developers of the compound, low-dose paroxetine killed young rats.)

Under rettssaken, fortalte Tracey jurymedlemmene at Food and Drug Administration (FDA) ikke ba om ytterligere sikkerhetsstudier for selektive serotoninreopptakshemmere (SSRIer) - den klasse antidepressiva som Seroxat tilhører - før i 2003. På dette tidspunkt erkjente angivelig GSK at Seroxat var assosiert med en økt risiko for fødselsdefekter. (...) (During the trial, Tracey reportedly told jurors that the Food and Drug Administration (FDA) did not order additional safety studies on selective serotonin reuptake inhibitors (SSRIs)- the class of antidepressants to which Paxil belongs - until 2003. At that point, GSK allegedly acknowledged there was an increased risk of birth defects associated with Paxil.)

MAKER OF 'HAPPY PILL' SEROXAT IS SUED BY MAN WHO KILLED WIFE WHILE ON DRUG
THISISLONDON.CO.UK 20.1.2008
Murderer Colin Dorey, who battered his wife to death with a hammer, is suing pharmaceuticals giant GlaxoSmithKline over his use of the anti-depressant Seroxat.

From his cell at Gartree prison in Leicestershire, Dorey, 48, has joined nearly 500 other users of the drug in a lawsuit against the multi-national, each seeking compensation of up to £50,000.

Their case is funded by legal aid at an estimated cost of hundreds of thousands of pounds to the taxpayer. (...)

GlaxoSmithKline Is Sued in U.K. Over Antidepressant Seroxat (GlaxoSmithKlines er saksøkt over antidepressivaet Seroxat i England)
bloomberg.com 8.1.2008
Jan. 8 (Bloomberg) -- GlaxoSmithKline Plc is being sued for as much as 15.7 million pounds ($31 million) by several hundred U.K. patients who said it was difficult to stop taking the antidepressant Seroxat.

``The claims are being brought here by people who allege they've had withdrawal,'' Mark Harvey, the lawyer who filed the suit in London, said today.

The U.K. lawsuit seeks between 15,000 pounds and 50,000 pounds each on behalf of 314 people who allege personal injury from Seroxat, known in the U.S. as Paxil, according to the Dec. 19 filing and the London High Court register. The patients claim negligence or statutory breach of duty dating back to 1997.

GlaxoSmithKline is also the target of more than 4,000 lawsuits in the U.S., combined in a federal court in Los Angeles, that allege Paxil users suffered withdrawal symptoms. While Harvey said he was aware of the U.S. lawsuits, the U.K. action is separate.

"We believe there is no merit in this litigation,'' GlaxoSmithKline said in an e-mailed statement today. "Seroxat has benefited millions of people worldwide who have suffered from depression.'' (...)

Withdrawal Symptoms From Paroxetine May Last For A Long Time (Seponeringssymptomer fra Seroxat (paroxetine) kan vare i lang tid)
medicalnewstoday.com 17.1.2008
(...) Now researchers at the University of Bologna headed by Prof. G.A. Fava confirm their account in an article published in the December 2007 issue of the International Journal of Neuropsychopharmacology. (...)

Now researchers at the University of Bologna headed by Prof. G.A. Fava confirm their account in an article published in the December 2007 issue of the International Journal of Neuropsychopharmacology. (...)

Patients were assessed with the Discontinuation-Emergent Signs and Symptoms (DESS) checklist 2 wk, 1 month and 1 yr after discontinuation. Nine of the 20 patients (45%) experienced a discontinuation syndrome, which subsided within a month in all but three patients who had been taking paroxetine for a long time. Discontinuation syndromes appeared to be fairly common even when performed with slow tapering and during clinical remission. In some cases disturbances persisted for months after discontinuation. (...)

- Parkinsonspasient får erstatning grunnet legemidlet Requips bivirkninger (- Pfizer må kompensere parkinsonpasienter som er blitt avhengige av gamling, sex og spiseforstyrrelser.) (- Det konfidensielle oppgjøret avslutter en fireårig rettssak for pasientene, hvorav noen spilte bort sine oppsparte midler etter å ha tatt legemidlet og hevdet at de ikke hadde hatt eksisterende gamblingproblemer.)

Pfizer must compensate Parkinson’s patients who became addicted (Pfizer må kompensere parkinsonpasienter som er blitt avhengige (gamling, sex og spiseforstyrrelser)
BMJ 2015; 350 BMJ 2015;350:h2565 (Published 14 May 2015)
Pfizer must compensate Parkinson’s patients who became addicted: An Australian court has approved payout deals for patients who developed gambling, sex, and eating addictions after taking cabergoline (marketed as Cabaser or Dostinex) to treat tremors associated with Parkinson’s disease or raised prolactin concentrations. The confidential settlement ends a four year court battle for the patients, some of whom gambled away their life savings after taking the drug and who claimed not to have had any pre-existing gambling problems. Others reported various forms of obsessive behaviour not normal to them, including compulsive eating, spending, hyper-sexuality, and performing repetitive tasks. (…)

(Anm: Spilleavhengighet (spilleavhengige/problemspillere) (mintankesmie.no).)

(Anm: Norsk pasientskadeerstatning (NPE). (mintankesmie.no).)

Parkinson's sufferer wins six figure payout from GlaxoSmithKline over drug that turned him into a 'gay sex and gambling addict' (Parkinsonspasient tilkjent sekssifret erstatningsbeløp fra GlaxoSmithKline for legemiddel som gjorde ham til "homofil sex- og spilleavhengig")
independent.co.uk 29.11.2012
Far til to barn sier han utviklet en ukontrollerbar lidenskap for homofil sex og gambling - på et tidspunkt solgte han sine barns leker for å finansiere sin avhengighet (Father-of-two says he developed an uncontrollable passion for gay sex and gambling - at one point even selling his children's toys to fund his addiction)

A French appeals court has upheld a ruling ordering GlaxoSmithKline to pay €197,000 (£159,000) to a man who claimed a drug given to him to treat Parkinson's turned him into a 'gay sex addict'.

Didier Jambart, 52, was prescribed the drug Requip in 2003 to treat his illness.

Within two years of beginning to take the drug the married father-of-two says he developed an uncontrollable passion for gay sex and gambling - at one point even selling his children's toys to fund his addiction.

He was awarded £160,000 in damages after a court in Rennes, France, upheld his claims.

The ruling, which is considered ground-breaking, was made yesterday by the appeal court, which awarded damages to Mr Jambart. (...)

- Sexgal av parkinsonmedisin.

(Anm: Her og nå hovedsending. Fredag 15. sep · Her og nå (…) 2. Sexgal av parkinsonmedisin. 3. Steinar Madsen om bivirkninger ved Parkinson-medisin (nrk.no 15.9.2017).)

- Sexgal av Parkinsonmedisiner

- Sexgal av Parkinsonmedisiner
vg.no 10.2.2011
SEXAVHENGIG: Didier Jambert, her sammen med kona i rettssalen i Nantes i Frankrike, fikk svært kraftige bivirkninger av medisinen mot Parkinsons sykdom.

Medisinen skulle hjelpe mot Parkinsons. I stedet hevder tobarnsfaren (51) at han ble både spillegal og sexavhengig.

Nå krever Didier Jambart fra Nantes i Frankrike rundt fire millioner kroner i erstatning fra legemiddelgiganten GlaxoSmithKline.

Ifølge nyhetsbyrået AFP hevder 51-åringen at medisinen Requip fikk ham hektet på gambling, uhemmet homofil sex og gjorde ham suicidal. (...)

Kjent effekt
Medisinsk direktør Olav Flaten i GlaxoSmithKline sier til VG at både spillegalskap og hyperseksualitet er kjente bivirkninger for Requip og lignende preparater.

- Dette er en mindre vanlig eller sjelden bivirkning, sier Flaten. (...)

- Medisinens største trussel

Glaxo Pays $90 Million to Settle States’ Avandia Claims (Glaxo betaler 90 millioner dollar for å forlike Avandia-krav)
businessweek.com 15.11.2012
GlaxoSmithKline Plc (GSK), the U.K.’s biggest drugmaker, agreed to pay $90 million to settle claims by 37 U.S. states and the District of Columbia that the company illegally promoted the Avandia diabetes medicine.

The settlement resolves claims by state attorneys general that Glaxo misled consumers about whether Avandia caused heart attacks and strokes to pump up sales. The company already has paid more than $3 billion to resolve government probes of its marketing of Avandia and other medications, as well as patient lawsuits over the diabetes drug.

“This settlement, which is covered by existing provisions, marks an important step in resolving long-standing legal matters,” Bernadette King, a U.S.-based spokeswoman for the company, said in an e-mailed statement. (...)

Medicine's Biggest Threat (Medisinens største trussel)
forbes.com 4.1.2012
Medicine’s biggest threat is not a highly resistant microorganism or rising costs or an aging population or workforce shortages. It is something less obvious and more dangerous: the issue of missing data.

Doctors, researchers, patients and the public routinely see only some of the evidence that has been produced about drugs and devices and other health care interventions. Many studies are designed, funded, and completed, yet the results remain out of sight and are never put in public view. This, after patients –have consented to participate and allow scientists to study them, often putting themselves at some risk or at least inconvenience. As incredible as it seems, the last step of disseminating the results of the completed study too commonly never occurs or is much delayed. And what is missing matters.

Medicine has promoted the use of systematic reviews of the medical literature. These studies of studies scour medical journals and databases for research about a particular topic and review them thoroughly, often bring together the results in statistical analyses with the intent of providing a verdict on a given approach. Systematic reviews seek to equip practitioners with the best summary of what is known on a particular topic.

We now recognize that there is often a big difference between what is published and what could be known about a medical intervention.

(Full disclosure: I served as a consultant to lawyers who represented patients who took Vioxx and have published articles on the data that was not in public view.)

Litigation over the antidepressant Paxil forced GlaxoSmithKline to release unpublished data that were subsequently used to indicate the risks associated with Avandia, the diabetes drug. The published data could not have supported the same conclusion. These experiences have led to calls for increased data sharing.

Now, this week the BMJ, a prominent medical journal, is publishing a series of articles (including one that I co-authored) that explore the pervasiveness of the problem. In one study, the investigators show that more than half of the trials sponsored by the National Institutes of Health remain unpublished even 30 months after the study is completed. This finding demonstrates that delays or omissions in publishing are not strictly an issue for industry.

In another article, unpublished data were shown to have an important influence on systematic reviews, changing perceptions about the risks and benefits of medical therapies. In this study of drugs, in about half the cases including the missing data made the drug appear more effective and in other half the drug seemed less effective. One could not predict the effect of the missing data. The point is that the missingness is not random – there is a bias in the undisclosed data that skews our perception of medical interventions.

The findings thus far suggest that no areas of medicine are immune from this problem. As a result, even the most diligent expert, reading all that has been published in a field, is handicapped by the lack of access to undisclosed information. (...)

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

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

29 mio. kr i erstatning til Omniscan-patient
dagenspharma.dk 4.4.2013
Medicinalfirmaet GE Healthcare har lidt nederlag i det amerikanske retssystem og skal betale stor erstatning til 61-årig amerikansk patient, der fik den invaliderende sygdom nefrogen systemisk fibrose efter undersøgelse med mr-kontrastmidlet Omniscan. (...)

Medicin-gigant punger ud i USA
bt.dk 5.7.2011
Betaler 3.000.000.000 i erstatning

Medicinalgiganten GE Healthcare udbetaler enorme summer i USA i erstatning til patienter, der er blevet invaliderede af stoffet Omniscan

Hele 400 patienter har fået erstatning, fordi de er blevet alvorligt syge og invalide efter de er blevet udsat for stoffet. Det viser papirer fra advokatfirmaet 'The John Restaino Law Firm', som B.T. er i besiddelse af.

Ifølge B.T.s oplysninger løber den samlede erstatningssum op på tre milliarder danske kr. i alt. Og der verserer omkring 100 sager i øjeblikket. Og flere støder givetvis til. Alle sagerne er afgjort ved forlig inden sagen nåede i retten.

B.T. afslørede tirsdag, at medicinalfirmaet GE Healthcare bevidst har fortiet vitale oplysninger om kontraststoffet Omniscan, som bruges når patienter skal røntgenfotograferes.

GE Healthcare lå siden starten af halvfemserne inde med oplysninger om at rotter og kaniner blev syge og døde, hvis de fik stoffet. De vidste desuden, at Omniscan frigiver det giftige tungmetal gadolinium ud i kroppen et stykke tid efter, at det er blevet sprøjtet ind.

Men Ge Healthcare fortalte intet om de oplysninger til danske læger og myndigheder, som i 1997 begyndte at lave forsøg med Omniscan på danske patienter med svage nyrer. Netop den patientgruppe er særligt udsat for forgiftning, da de udskiller stoffet langsommere end raske.

I dag vurderer Nyreforeningen at 50 danske patienter er døde ud af de cirka 100, der er blevet syge. (...)

(Anm: Computertomografi (CT), magnetisk resonanstomografi (MR), positronemisjonstomografi (PET), ultrasonografi (ultralyd), kontrastmidler etc. (mintankesmie.no).)

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. (...)

Diverse artikler

16 får nej til erstatning efter HPV-vaccination
dagenspharma.dk 5.2.2014
70 Kvinder har søgt erstatning for bivirkninger til HPV-vaccinen. 27 sager er afgjort, men kun to har fået erstatning. (...)

Antidepressiv medicin forbundet med lungesygdom hos nyfødte
dagenspharma.dk 23.1.2014
Mødres brug af SSRI-præparater sent i graviditeten kan øge fostrets risiko for at udvikle forhøjet blodtryk i lungerne. (...)

Antidepressants in Pregnancy Tied to Slight Risk of Lung Disorder in Babies (Antidepressiva i svangerskapet knyttet til en liten økning i lungelidelser hos babier)
consumer.healthday.com 15.1.2014
But, overall risk of 'persistent pulmonary hypertension' remains low, study finds

(HealthDay News) -- Taking certain antidepressants in late pregnancy more than doubles the odds of a lung complication in newborns, a new review says.
Fortunately, the study also found that the absolute risk of the complication -- known as persistent pulmonary hypertension -- was still low, affecting about 3.5 out of every 1,000 births, according to study author Dr. Sophie Grigoriadis.

"Women taking these medications in pregnancy should not panic. The risk is still quite low. It should be one of the factors you consider when you decide to use medications, but it has to be balanced with the potential problems that can occur if you don't treat depression," said Grigoriadis, head of the Women's Mood and Anxiety Clinic: Reproductive Transitions at Sunnybrook Health Sciences Center, in Toronto. (...)

Takeda Failed to Properly Warn About Actos Risks, Jury Rules (1)
businessweek.com 26.9.2013
A Maryland jury ruled that Takeda Pharmaceutical Co. (4502) didn’t properly warn an ex-U.S. Army translator and his doctor about the risks of its Actos diabetes drug and ordered the company to pay more than $1.7 million in damages. A judge immediately threw out the verdict.

Jurors in state court in Baltimore deliberated more than six hours over two days before finding Asia’s largest drugmaker liable for the cancer death of Diep An, Michael Miller, one of An’s lawyers, said in an interview. Since jurors also found that An contributed to his death by smoking for 30 years, Judge Brooke Murdock set the verdict aside based on Maryland law.

“We consider the verdict to be a vindication of our claims that Takeda failed to properly disclose the risks of this drug,” Stuart Simms, another lawyer representing the An family, said today in an interview.

It’s the second time a U.S. jury has found that Osaka, Japan-based Takeda hid Actos’s links to bladder cancer. The drugmaker, which faces more than 3,000 suits over the drug, is preparing for trials in state courts in Las Vegas and Chicago and a federal court in Louisiana during the next four months.

“We believe we acted responsibly and we are pleased with the judgment in favor of Takeda,” Ken Greisman, a U.S.-based spokesman for Takeda, said in an interview. (...)

Pharma's Top 11 Marketing Settlements
fiercepharma.com 26.7.2013
The Justice Department is growing more and more impatient. For more than a decade, its lawyers and investigators have been slapping drugmakers around for their marketing misdoings. They've insisted on bigger and bigger penalties, especially during the last several years, with penalties and payments commonly topping $500 million. And yet the whistleblower lawsuits and off-label settlements keep coming. (...)

Jury hits Takeda with $6.5M judgment in first Actos liability case
fiercepharma.com 29.4.2013
Japanese drugmaker faces another 3,000 lawsuits over drug's links to bladder cancer

Score one for the plaintiffs in Takeda Pharmaceuticals' Actos litigation. A California jury weighed in against the drugmaker, deciding that Takeda didn't do enough to warn patient Jack Cooper about a heightened risk of bladder cancer. The company was ordered to pay $6.5 million in the case--and more than 3,000 lawsuits are still outstanding.

It was the first bladder-cancer trial for Takeda, in a bellwether suit heard in State Judge Kenneth Freeman's court. A number of similar suits have been consolidated in that court, as Bloomberg reports, with another set under review in Illinois. Some 1,200 federal lawsuits are gathered in a Louisiana court.

The trial went on for two months, as jurors heard allegations that Takeda ignored, hid and downplayed the diabetes pill's links to bladder cancer. Cooper and other plaintiffs contend that Takeda kept back reports about Actos risks and even misled the FDA about its potential dangers. One expert witness highlighted a 2005 email exchange, in which executives discussed new data on Actos patients' risks of bladder cancer. The "worst-case scenario," they said, would be label warnings highlighting the drug's links to cancer. So, employees needed to work with regulators for a "positive outcome," the emails noted. (...)

Diabetesmiddel kædes sammen med kræft
medwatch.dk 17.4.2013
Diabetesmedicin fra den japanske koncern Takeda er i en retssag – den første af hele 3.000 – blevet beskyldt for at forårsage kræft. Samtidig beskyldes koncernen for at have kendt til problemet igennem syv år uden at gøre opmærksom på det. Det skriver Bloomberg.

Asiens største medicinalvirksomhed, Takeda Pharmaceutical Co., skjulte en risiko for kræft forbundet med lægemidlet Actos for at beskytte sit milliardsalg af midlet, blev en amerikansk jury fortalt under den første af mere end 3.000 retssager pga. diabetesmedicinen.

Selvom Takedas egne, interne studier med Actos kædede medicinen sammen med blærekræft allerede i 2004, så gjorde virksomheden ikke de amerikanske myndigheder opmærksom på problemet før syv år senere, forklarede Michael Miller, som fører den pågældende sag, til juryen ved en domstol i Los Angeles mandag. Han tilføjer, at selskabet hemmeligholdt oplysningerne for at beskytte de mere end 1,6 mia. dollar, som Actos solgte for årligt.

”At sælge diabetesmedicin er ’big business’ i Amerika. Man kan tjene mane penge. Men virksomhederne har en pligt til at oplyse om risikoen. Patientsikkerhed bør komme i første række,” sluttede han med at sige.

I Januar opnåede Takeda godkendelse af Nesina - et nyt diabetesmiddel, som skal tage over for Actos, der gik af patent sidste år. Salg af Actos nåede sit højdepunkt i regnskabsåret, der sluttede i marts 2011, med 4,5 mia. dollar, hvilket svarede til 27 pct. af selskabets indtjening på det tidspunkt, ifølge data fra Bloomberg. (...)

Takeda’s Actos Diabetes Drug Tied to Cancer, Jury Is Told (Takedas diabeteslegemiddel Actos knyttet til kreft, er juryen fortalt)
bloomberg.com 17.4.2013
Takeda Pharmaceutical Co. (4502), Asia’s biggest drugmaker, hid the cancer risks of its Actos drug to protect billions in sales, a jury was told in the first of more than 3,000 lawsuits over the diabetes medication to go to trial.

While Takeda’s internal Actos studies uncovered links to bladder cancer as early as 2004, the company didn’t alert U.S. regulators until seven years later, Michael Miller, a lawyer for plaintiff Jack Cooper, told a state court jury in Los Angeles yesterday. The company kept quiet to protect more than $1.6 billion in annual Actos sales, he added.

“Selling diabetes drugs is big business in America,” Miller said in closing arguments in the trial of Cooper’s suit against Takeda. “There’s a lot of money to be made. But companies are not allowed to downplay the risk. Patient safety is the No. 1 thing.” (...)

Pfizer Settles First Chantix Suicide Case Set for Trial (Pfizer forliker første søksmål i selvmordssak for retten mot Chantix)
businessweek.com 18.10.2012
Pfizer Inc. (PFE) reached a confidential settlement with the widow of a Minnesota man who killed himself after taking its anti-smoking drug Chantix, averting a trial set to begin next week.

The widow of Mark Alan Whitely sued Pfizer after his death in November 2007, alleging the company failed to sufficiently warn that Chantix could increase the risk of suicide. The Whitely lawsuit was the first of more than 2,500 Chantix cases pending in federal court in Alabama set for trial, according to court records.

“We can confirm that we have settled this case,” Chris Loder, a Pfizer spokesman, said in an e-mailed statement today. “Terms are confidential.” (...)

(Anm: FDA warn Chantix could affect patients' alcohol tolerance (medicalnewstoday.com 10.3.2015).)

Helle (22) fikk blodpropp av p-piller – vant mot staten
tb.no 15.9.2012
TØNSBERG: En årelang kamp for å få tilkjent pasientskadeerstatning er over for Helle Svanevik (22). Hun fikk blodpropp etter p-pillebruk. (...)

På grunn av de alvorlige bivirkningene, ble saken klaget inn for Helsetilsynet i Vestfold som konkluderte med at Helle hadde fått mangelfull informasjon om mulige bivirkninger og mangelfull oppfølging hos sin lege.

Likevel mente det lokale helsetilsynet at saken ikke var så alvorlig at den burde sendes til Statens helsetilsyn. Dermed sendte Svanevik-familien en skademelding til Norsk pasientskadeerstatning (NPE) rett før jul i 2009. Kravet om erstatning ble ikke tatt til følge her heller. (...)

(Anm: Voldsoffererstatning (vold) (mintankesmie.no).)

(Anm: Fri rettshjelp (frirettshjelp.no/innvilgelseskompetanse).)

(Anm: – Tall fra Statens sivilrettsforvaltning, som bygger på innrapportering fra fylkesmennene, viser at så mange som to tredjedeler fikk avslag på sine søknader om fri rettshjelp i perioden 2010 til 2012 Saksøker staten – nektes fri rettshjelp (nrk.no 19.11.2013.)

(Anm: Norsk pasientskadeerstatning (NPE). (mintankesmie.no).)

(Anm: Gruppesøksmål (massesøksmål) (mintankesmie.no).)

(Anm: Klager: Fylkeslegen – Helsetilsynet (Statens helsetilsyn) - Fylkesmannen - Fylkesnemndene for barnevern og sosiale saker (mintankesmie.no).)

(Anm: Sivilombudsmannen (SOM) (mintankesmie.no).)

(Anm: Rettferdsvederlag (Stortingets rettferdsvederlagsordning) (tidligere billighetserstatning) (mintankesmie.no).)

- Statens oppreisningsansvar ved menneskerettighetsbrudd.

(Anm: Statens oppreisningsansvar ved menneskerettighetsbrudd. I Norge har erstatningsretten utviklet seg parallelt med – og uavhengig av – en stadig større bruk av menneskerettigheter i offentlig rett og i privatretten for øvrig. Menneskerettighetene har derfor ikke fullt ut ... Tidsskrift for erstatningsrett, forsikringsrett og trygderett01 / 2017 (Volum 2) Side: 3-6.)

- Erstatning for ikke-økonomisk tap ved krenkelser av EMK.

(Anm: Av Henrik Vaaler - (master i rettsvitenskap 2016) jobber som advokatfullmektig i Regjeringsadvokaten. Erstatning for ikke-økonomisk tap ved krenkelser av EMK. Sammendrag. EMK artikkel 13 gir personer som har vært utsatt for konvensjonskrenkelser, rett til et effektivt botemiddel på nasjonalt nivå. For å være effektivt må botemidlet kunne gi reparasjon. Artikkelen redegjør for når reparasjonen må bestå i erstatning for ikke-økonomisk tap, og hvilke følger det får for ansvarsgrunnlaget i nasjonal rett. Avslutningsvis går artikkelen inn på norsk rett, og fastlegger når artikkel 13 bør kunne anvendes direkte som erstatningsgrunnlag for norske domstoler. I en rekke saker de siste årene har private parter gått til norske domstoler og krevd erstatning for krenkelser av Den europeiske menneskerettskonvensjon (EMK). Antallet søksmål synes å være økende. Sakene har til felles at saksøkerne, foruten å påberope ulovfestet objektivt ansvar eller oppreisningsbestemmelsen i skadeserstatningsloven (ski.) § 3-5, anfører at staten er forpliktet etter EMK til å tilkjenne erstatning for øko­nomisk og ikke-økonomisk tap på objektivt grunnlag ved krenkelser av konvensjonen, og at EMK utgjør et selvstendig erstatningsgrunnlag i norsk rett. Artikkelen vil se nærmere på begge spørsmålene.(...) AVSLUTTENDE BEMERKNINGER Ved å anvende artikkel 13 direkte som erstatningsgrunnlag vil norsk rett klart tilby et effektivt botemiddel. En direkte tillempning av artikkel 13 er likevel ikke den eneste eller nødvendigvis den beste måten å overholde konvensjonen på. Artikkel 13 er ikke utformet med sikte på å være en nasjonal erstatningshjemmel, og tilbyr ikke noen hel­hetlig erstatningslære. (...) Lov og Rett 05 / 2017 (Volum 56)Side: 299-317.)

Millionerstatning til vaksineofre
tv2nyhetene.no 8.9.2012
Norsk pasientskadeerstatning har betalt ut nesten 10 millioner kroner for skader forårsaket av massevaksineringen mot svineinfluensa for tre år siden.

En fersk kartlegging viser at 54 barn har fått sykdommen narkolepsi etter å ha blitt vaksinert med Pandemrix. 18 av dem er hittil tilkjent erstatning, skriver Vårt Land.
Ytterligere fire er tilkjent erstatning for skader de fikk som følge av selve sprøytestikket.

Norsk pasientskadeerstatning hadde i juni fått inn 206 krav om erstatning etter massevaksineringen med Pandemrix. Foruten de 22 som har fått medhold, har 37 fått avslag. De resterende kravene er ikke ferdigbehandlet. (...)

Pharmaceuticals And The Law: It's Not What You Think
seekingalpha.com 27.8.2012
Pharmaceutical companies are no stranger to the courtroom. Pfizer (PFE) is in court, as it tried to protect its cash cow drug, Lipitor, and fears should be warranted here. Sanofi Aventis (SNY) and Bristol-Myers Squibb (BMY) are accused of side effect damages, though it should not hurt their already successful year.

GlaxoSmithKline (GSK), of course, paid out an egregious settlement, but still stands strong. Lastly, Novartis (NVS) is challenging a law that may change the industry at large, but will it help its bottom line? Let's have a look at these companies individually. (...)

Diabetics sue drugs giant GlaxoSmithKline over heart risk (Diabetikere saksøker legemiddelgiganten GlaxoSmithKline over hjerterisiko)
dailyrecord.co.uk 15.7.2012
Skotske diabetikere er saksøker legemiddelgigant etter at de utbetalte 3 milliarder dollar til amerikanske ofre. (SCOTTISH diabetics are suing a drugs giant after they made a $3billion payout to US victims.)

Forrige uke fikk GlaxoSmithKline rekordstor straffe- og sivilrettslig bot i forbindelse med tre omstridte legemidler inkludert Avandia, som nå er forbudt i Europa. (Last week, GlaxoSmithKline were hit with the record criminal and civil fine in connection with three controversial drugs including Avandia, which is now banned in Europe.)

Den britiske firmaet innrømmet at de unnlot å rapportere sikkerhetsproblemer for diabeteslegemiddel som øker risikoen for hjerteinfarkt. (...) (The UK firm admitted they failed to report safety issues with the diabetes medication, which increases the risk of heart attacks.)

For the latest pharmaceutical news and updates - Sign up now!
pharmpro.com 1.6.2012
BATON ROUGE, La. (AP) — GlaxoSmithKline has filed suit against Louisiana Attorney General Buddy Caldwell, alleging that private attorneys hired by Caldwell to prosecute the state's lawsuit against the company have a "personal financial interest" in the suit's outcome.

The Advocate reports (http://bit.ly/N3dWEp) GlaxoSmithKline claims the fee agreement Caldwell has with the attorneys violates the state Constitution and the company's constitutional rights. The firm wants a judge to bar Caldwell from prosecuting the state's suit through private attorneys.
State Attorney General's Office spokeswoman Amanda Larkins issued a statement that read, "We have total confidence in the procedures relied upon to institute this important work for the State."

The state sued GSK in February 2011, alleging the firm misrepresented the safety and efficacy of its prescription diabetes drug Avandia. (...)

Omnicare Pays $50 Million To Settle DOJ Case
manufacturing.net 11.5.2012
CLEVELAND (AP) — Omnicare will pay $50 million to settle allegations that it improperly dispensed drugs for nursing home patients without a doctor's signed prescription since 2007, the government announced Friday.

U.S. Attorney Steven Dettelbach said at a news conference that it was the second largest monetary settlement nationally in the history of the Controlled Substances Act regulating drugs.

The Covington, Ky.-based company, which sells drugs to long-term care providers like hospitals and nursing homes, said there were no allegations that drugs were illegally diverted to someone without prescriptions and no patients were harmed.

The charges stemmed from a previously announced investigation by the Drug Enforcement Administration.

At issue was how pharmacy managers communicate with doctors who write prescriptions for controlled substances. (...)

Pfizer Settles Celebrex Lawsuit (Pfizer forliker Celebrex-søksmål)
pharmatimes.com 2.5.2012
Pfizer Inc. has settled a lawsuit filed by Brigham Young University over development of the blockbuster painkiller Celebrex for $450 million, according to a regulatory filing. Terms of the settlement weren't disclosed in an announcement by the drug company and the Mormon Church-owned school in Utah. However, Pfizer said in a regulatory filing with the U.S. Securities and Exchange Commission that it was taking a $450 million charge against first-quarter earnings to settle the case.

BYU and Pfizer battled for six years over the discovery of an enzyme that led to the development of Celebrex, a breakthrough in the treatment of arthritis and inflammation. A jury trial had been set to start May 29 in U.S. District Court in Salt Lake City. BYU had sought a 15 percent royalty on sales of Celebrex, or about $9.7 billion. The university also could have sought billions of dollars more in punitive damages and interest.
BYU's lawsuit said a chemistry professor, Daniel Simmons, discovered the genetic workings of the drug in the early 1990s. It accused Pfizer of violating a research agreement the school made with predecessor companies. As part of the settlement, BYU plans to endow a Dan Simmons Chair in recognition of his lifelong work advancing human health. (...)

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. (...)

RD Legal Funding Offers Lawsuit Financing to Plaintiff Attorneys with Avandia Settlements
marketwatch.com 29.3.2012
CRESSKILL, N.J., March 29, 2012 /PRNewswire via COMTEX/ -- Even after published studies described Avandia's dangerous side effects, Type 2 diabetes sufferers, who are at the highest risk of developing fatal heart disease, were prescribed the drug in order to lower their blood sugar levels. Tens of thousands of suits have been settled by GlaxoSmithKline to resolve claims that its drug Avandia increased the risk of heart attack in Type 2 diabetes patients. Plaintiff attorneys with Avandia settlements, who are still waiting to get paid, are encouraged to contact RD Legal Funding, LLC ("RD Legal"), one of the nation's leading providers of lawsuit funding to attorneys. (...)

Generic Drugs Proving Resistant to Damage Suits
nytimes.com 20.3.2012
Debbie Schork, a deli worker at a supermarket in Indiana, had to have her hand amputated after an emergency room nurse injected her with an anti-nausea drug, causing gangrene. She sued the manufacturer named in the hospital’s records for failing to warn about the risks of injecting it. Her case was quietly thrown out of court last fall. (...)

Tre barn får svineinfluensa-erstatning
tv2nyhetene.no 8.2.2012
UTVIKLET NARKOLEPSI: Norsk pasientskadeerstatning har konkludert med at det er sannsynlig at tre barn fikk narkolepsi som følge av pandemrixvaksinen. (...)

Etter en grundig vurdering av om pandemrixvaksinen kan være årsak til narkolepsitilstanden, har Norsk pasientskadeerstatning (NPE) gitt barna medhold, melder NRK.

De tre barna er i alderen 8 til 15 år. (...)

GlaxoSmithKline Agrees to Settlement in 20,000 Avandia Lawsuits
openpr.com 5.2.2012
(openPR) - Nadrich & Cohen, LLP reports that GlaxoSmithKline has agreed to settle approximately 20,000 Avandia side effects lawsuits.

Los Angeles, CA, February 3, 2012 – UK drug-maker GlaxoSmithKline has agreed to settle 20,000 Avandia side effects lawsuits. According to a Bloomberg report, the company previously agreed to pay at least $700 million to settle more than 15,000 claims on behalf of patients who said that the drug caused heart attacks, strokes and other complications.

Avandia (rosiglitazone) was first approved by the FDA in 1999 to treat Type 2 diabetes in adult patients. The drug hit the market the same year as another popular diabetes drug, Actos (pioglitazone). The maker of Actos, Takeda Pharmaceuticals, is now facing numerous lawsuits from patients who claim the drug caused them to develop bladder cancer. (...)

Pfizer Says Nearly Half of Prempro Lawsuits Are Settled
pharmpro.com 16.12.2011
According to a Securities and Exchange Commission filing, Pfizer has settled almost 5,000 lawsuits, or 46 percent of cases, related to allegations that patients developed breast cancer after taking the company's hormone replacement therapies Prempro, Premarin and Provera, Bloomberg reported Thursday.

The drugmaker also indicated that it has set aside a further $68 million in addition to the $772 million it set aside for the cases in May, at which time Pfizer said it had resolved a third of the lawsuits, or about 3300. "We have recorded a charge of $260 million in the first nine months of 2011 that provides for the minimum expected costs to resolve all the remaining hormone-replacement actions," Pfizer officials said in the filing. However, the company noted that the reserve for the remaining lawsuits is only "an estimate" and "additional charges may be required." (...)

Pfizer sued by parents claiming Zoloft use caused birth defects
madisonrecord.com 30.11.2011
The ingestion of Zoloft during pregnancy led eight different couples to parent children born with various birth defects, according to a recently filed lawsuit that name the drug's manufacturer as a defendant. (...)

Merck betalar miljardbelopp för Vioxx
lakemedelsvarlden.se 23.11.2011
Läkemedelsföretaget Merck har valt att betala 950 miljoner dollar för att man marknadsförde det nu indragna smärtläkemedlet Vioxx som behandling för en icke godkänd indikation. (...)

Merck settles Vioxx suits from New York, Florida
reuters.com 14.11.2011
(Reuters) - Merck & Co has reached settlements to resolve lawsuits from the states of New York, Florida and South Carolina alleging the company misled state regulators about the dangers of the painkiller Vioxx, according to court filings.

The confidential sums were revealed in a court filing Friday in the U.S. District Court for the Eastern District of Louisiana, where thousands of Vioxx cases have been consolidated. In 2007, Merck had agreed to pay out $4.85 billion to resolve claims from thousands of plaintiffs who said Vioxx caused heart attacks.

A spokesman for Merck declined further comment on the settlements. They were revealed in a court filing from attorneys for the plaintiffs' steering committee in the multi-district Vioxx litigation, which asked the court to set aside 6.5 percent of the state settlements in an escrow fund to pay for plaintiffs' legal fees.

Attorney generals for the state of New York, Florida and South Carolina filed lawsuits against Merck in 2007 and 2008 alleging the company misled state regulators about the dangers associated with Vioxx, which has been linked in lawsuits to increasing users' risk of heart attacks and other serious cardiovascular side effects.
Similar settlements have already been reached in lawsuits from the states of Alaska, Kentucky, Mississippi, Montana, Oklahoma and Utah, according to the filing. (...)

Novo Nordisk anklaget for bestikkelse
bt.dk 25.9.2011
Læge står frem: Fik hotelophold, restaurantbesøg og penge

Militærlæge Ian Black fortæller om bestikkelse fra Novo Nordisk.

Novo Nordisk er anklaget for at have bestukket læger i det amerikanske militær til at bruge et medicin mod blødninger. Men medicinen har ikke en dokumenteret virkning.

Nu står en af lægerne frem i 21 Søndag på DR 1. Den amerikanske militærlæge Ian Black brugte medicinen til sårede amerikanske soldater, men han fandt ud af, at det ikke virkede. Militærlægen oplevede alvorlige bivirkninger, når han brugte det på amerikanske soldater.

- Jeg oplevede hjerteanfald, slagtilfælde og mærkelige blodpropper i indvoldene, fortæller Ian Black i 21 Søndag på DR 1.

Ifølge DR’s indslag i aftes viste en undersøgelse i 2005, at næsten 10 pct. af de, der blev behandlet med NovoSeven, fik blodpropper. Dermed blev Ian Blacks observationer bekræftet.

Alvorlige bivirkninger
Den påstand bakkes op af Steffen Thirstrup, som er leder af Lægemiddelstyrelsen i Danmark. Ifølge Lægemiddelstyrelsen er der ingen dokumentation for virkningen af medicinen.

- Lægemidlet bliver brugt til patienter, der ikke har gavn af det. De har på bundlinjen kun risiko for blodpropper, siger han til 21 Søndag. Lægemiddelstyrelsen kritiserer Novo Nordisk for at have tjent millioner kroner på medicinen, uden at der er blevet lavet kliniske studier, der viser, om den virker.

- Der er tale om medicin med de alvorligste bivirkninger, nemlig at man kan få blodpropper og dø af det, siger Steffen Thirstrup.

Efter indslaget fortalte Kim Bildsøe Lassen, at Novo Nordisk havde solgt for 1,2 mia. kr off-label, altså til formål, der ikke er godkendt.

Sag mod Novo Nordisk
Da Ian Black opdagede bivirkningerne gik han til myndighederne, og det amerikanske justitsministerium lagde sag an mod Novo Nordisk.

Militærlægen var kronvidne og whistleblower i sagen. Det var altså ham, der fortalte ministeriet om de alvorlige følger af NovoSeven, og om at Novo Nordisk havde bestukket ham og andre læger.

- Jeg blev tilbudt ubegrænsede penge til uddannelse, gode middage på dyre restauranter og firestjernede hotelophold, siger Ian Black.

Men sagen kom aldrig i retten, og i stedet invilligede Novo Nordisk i at betale 25 mio. dollars - ca. 130 mio. kr - i et forlig. Ian Black mener, at det forlig har været en god forretning for Novo Nordisk.

- 25 mio. dollars er mange penge, men sammenlignet med de mange mio., de har tjent, så er det ikke ret meget, siger han til 21 Søndag. (...)

Mother suing Paxil maker does not have to disclose medical records: judge (Mor som saksöker Seroxat (Paxil)-produsent trenger ikke å offenliggjøre medisinske journaler, ifølge dommer)
vancouversun.com 6.9.2011
The mother of a girl born with a heart defect who is suing the maker of the antidepressant Paxil does not have to disclose her medical records before a class-action certification, a Vancouver judge ruled last week.

The mother, Faith Gibson of Surrey, launched the lawsuit three years ago in B.C. Supreme Court against GlaxoSmithKline, claiming the drug company failed to provide adequate information regarding the risks of birth defects for women taking Paxil during pregnancy.

Gibson's daughter Meah was born six years ago with a hole in her heart, which required surgery and seven months in hospital. (...)

Murder victim's mom sues killer's family
WINNIPEGSUN.COM 30.8.2011
Accused blames Prozac for fatal attack

The mother of murdered teen Seth Ottenbreit is suing his killer’s parents, grandfather and brother, alleging their inaction led to Ottenbreit’s death.

The now 18-year-old accused cannot be named. He has pleaded guilty to second-degree murder and is set to be sentenced next month.

Ottenbreit, 15, was fatally stabbed in September 2009. The accused has blamed the killing on his use of the antidepressant Prozac.

In a lawsuit filed last week Ottenbreit’s mother, Donna Noble, alleges the killer’s parents should have known their son “was uncontrollable, dangerous, unpredictable and suicidal and could not be trusted.”

Court has heard the accused fatally stabbed Ottenbreit after learning he had damaged the hardwood floor of his parent’s West St. Paul home. (...)

Novo Nordisk anklages for at smøre militærlæger
business.dk 23.8.2011
Den amerikanske hær begyndte i 2004 at bruge NovoSeven som standardbehandling til sårede amerikanske soldater i Irak.

Millionforlig i sag, hvor Novo Nordisk mistænkes for at give limousinetransport og dyre middage til militærlæger, hvidvaskning af bestikkelse til lægerne og ulovlig betaling for forsøg med sårede soldater i Irak og Afghanistan.

Det er ikke småting, Novo Nordisk beskyldes for at stå bag, når man læser søgsmålet om ulovlig markedsføring af blødermedicinen NovoSeven, som det amerikanske justitsministerium sammen med 24 delstater og to såkaldte whistleblowers afleverede for snart to år siden.

Søgsmålet, som først nu er kommet til offentlighedens kendskab, resulterede i juni i år i, at Novo Nordisk indgik et 130 millioner kroner stort forlig, uden at den danske medicinalkoncern erkender skyld. Novo Nordisks ledelse fastholder, at selskabet ikke har gjort noget forkert.

Søgsmålet tegner billedet af en virksomhed, hvis sælgere har været villige til at gå langt for at leve op til de store krav, som blev stillet til dem fra virksomhedens side. I anklageskriftet konstateres det, at Novo Nordisk på systematisk vis forsøgte at få udbredt brugen af NovoSeven til behandling af traumepatienter, selv om midlet ikke var godkendt til formålet. (...)

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. (...)

Pfizer: Nigeria drug trial victims get compensation
bbc.co.uk 11.8.2011
Pfizer has agreed to sponsor health projects in Kano

Continue reading the main story

Related Stories

Anger at deadly Nigerian drug trials
Pfizer: No Nigeria dirty tricks
Public 'misled' over drug trials

US-based pharmaceutical giant Pfizer has made the first compensation payment to Nigerian families affected by a controversial drug trial 15 years ago.

It paid $175,000 (£108,000) each to four families in the first of a series of payments it is expected to make.

The payouts are part of an out-of-court settlement reached in 2009.

In 1996, 11 children died and dozens were left disabled after Pfizer gave them the experimental anti-meningitis drug, Trovan.

The children were part of a group of 200 given the drug during a meningitis epidemic in the northern city of Kano as part of a medical trial comparing Trovan's effectiveness with the established treatment. (...)

Judge orders drug company to pay SC $327 million (Dommer beordrer legemiddelfirma å betale SC (South Carolina) 327 millioner dollar)
pharmpro.com 3.6.2011
A Johnson & Johnson subsidiary must pay South Carolina $327 million for deceptive marketing of an antipsychotic drug, a Spartanburg County judge ruled Friday.
A spokeswoman for the drugmaker said the company was disappointed and would appeal.

Under the order issued by Circuit Court Judge Roger Couch, Janssen Pharmaceutica Inc. — a subsidiary of the New Brunswick, N.J.-based drug manufacturer — must make the payment for violations of the South Carolina Unfair Trade Practices Act.

"There is absolutely no doubt in my mind that the desire to protect market share overshadowed the good judgment of those in control at Janssen," Couch wrote.

Violations of that law carry potential penalties of up to $5,000 apiece, meaning the company had faced possible consequences of more than $3.1 billion, considering the 620,000 Risperdal prescriptions written for people on Medicaid and the state health plan alone. (...)

According to his order, Couch assessed a $300 penalty per sample box of the drug that was distributed and a $4,000 penalty per publication of the "Dear Doctor" letter, for a total penalty of more than $327 million. (...)

SC prosecutor suing GlaxoSmithKline over Avandia
pharmpro.com 1.6.2011
British drug maker GlaxoSmithKline PLC improperly marketed the diabetes drug Avandia to South Carolina consumers, hiding the medication's harmful side effects, according to a lawsuit filed by the state's top prosecutor.

A spokeswoman for the company, however, said GlaxoSmithKline supports both its drug and the ways in which it was marketed.

In a lawsuit filed May 17 in Spartanburg County, Attorney General Alan Wilson argued that the drug maker acted negligently when it claimed that Avandia did not put patients' hearts at risks and could actually reduce the potential for heart problems.

"GSK did not just fail to disclose the potential cardiovascular risks Avandia posed, which include heart attacks and sudden cardiac death, it affirmatively represented that Avandia could reduce diabetics' cardiovascular risks," Wilson wrote. "GSK knew or should have known that these representations were not true and likely to deceive."

First approved by the Food and Drug Administration in 1999, Avandia quickly became the top-selling diabetes pill in the world. The drug works by increasing the body's sensitivity to insulin, a key protein needed for digestion that diabetics don't adequately produce. (...)

Massesøksmål i USA
aftenposten.no 23.5.2011
Mange nyresyke er blitt ofre for alvorlig bivirkning

Det norskutviklede MR-kontrastmiddelet Omniscan har ført til hundrevis av søksmål mot helsegiganten GE Healthcare i USA.

I USA har nær 1000 pasienter saksøkt produsenter av MR-kontrastvæske etter at de er blitt syke. I flere av sakene er det inngått forlik de siste årene. Omniscan var involvert i rundt 70 prosent av sakene, ifølge den amerikanske erstatningsadvokaten Peter J. Brodhead. Han sitter i komiteen for saksøkerne.

Millionerstatning. Aftenposten skrev i går om familien Sedal, som har fått tilbud om erstatning fraNorsk pasientskadeerstatning etter at faren døde 46 år gammel. Han ble gradvis mer invalidisert etter en MR-undersøkelse der Omniscan ble brukt som kontrastmiddel, og døde fire år senere. (...)

Får erstatning etter farens smertefulle død
aftenposten.no 22.5.2011
Syk etter bruk av MR-kontrastmiddel

Som tenåring pleiet Ingrid Hæve Sedal (21) sin dødssyke far. Nå er familien tilbudt drøyt 2,8 millioner kroner i erstatning. Som eldste datter får hun 100000 kroner i erstatning.

Nyresyke Petter Sedal (46) døde i desember 2006, rett før det ble slått internasjonal helsealarm om at MR-kontrastmidler kunne skade nyrepasienter. 46-åringen fikk den invalidiserende og mystiske bivirkningen Nefrogen systemisk fibrose (NSF).

På verdensbasis er det funnet over 800 tilfeller av tilstanden NSF hos nyrepasienter som har fått MR-kontrastvæske, ifølge en rapport fra GE Healthcare. Over 500 av disse pasientene fikk kontrastmiddelet Omniscan.

Det er to kjente dødsofre av bivirkningen i Norge, ifølge Statens legemiddelverk. De fikk injeksjoner med henholdsvis MR-kontrastmidlene Omniscan og Magnevist.

Sedal er det eneste dødsofferet som har fått medhold i krav om erstatning fra Norsk pasientskadeerstatning. (...)

(Anm: Voldsoffererstatning (vold) (mintankesmie.no).)

(Anm: Fri rettshjelp (frirettshjelp.no/innvilgelseskompetanse).)

(Anm: Norsk pasientskadeerstatning (NPE). (mintankesmie.no).)

(Anm: Gruppesøksmål (massesøksmål) (mintankesmie.no).)

(Anm: Klager: Fylkeslegen – Helsetilsynet (Statens helsetilsyn) - Fylkesmannen - Fylkesnemndene for barnevern og sosiale saker (mintankesmie.no).)

(Anm: Sivilombudsmannen (SOM) (mintankesmie.no).)

(Anm: Rettferdsvederlag (Stortingets rettferdsvederlagsordning) (tidligere billighetserstatning) (mintankesmie.no).)

- Statens oppreisningsansvar ved menneskerettighetsbrudd.

(Anm: Statens oppreisningsansvar ved menneskerettighetsbrudd. I Norge har erstatningsretten utviklet seg parallelt med – og uavhengig av – en stadig større bruk av menneskerettigheter i offentlig rett og i privatretten for øvrig. Menneskerettighetene har derfor ikke fullt ut ... Tidsskrift for erstatningsrett, forsikringsrett og trygderett01 / 2017 (Volum 2) Side: 3-6.)

- Erstatning for ikke-økonomisk tap ved krenkelser av EMK.

(Anm: Av Henrik Vaaler - (master i rettsvitenskap 2016) jobber som advokatfullmektig i Regjeringsadvokaten. Erstatning for ikke-økonomisk tap ved krenkelser av EMK. Sammendrag. EMK artikkel 13 gir personer som har vært utsatt for konvensjonskrenkelser, rett til et effektivt botemiddel på nasjonalt nivå. For å være effektivt må botemidlet kunne gi reparasjon. Artikkelen redegjør for når reparasjonen må bestå i erstatning for ikke-økonomisk tap, og hvilke følger det får for ansvarsgrunnlaget i nasjonal rett. Avslutningsvis går artikkelen inn på norsk rett, og fastlegger når artikkel 13 bør kunne anvendes direkte som erstatningsgrunnlag for norske domstoler. I en rekke saker de siste årene har private parter gått til norske domstoler og krevd erstatning for krenkelser av Den europeiske menneskerettskonvensjon (EMK). Antallet søksmål synes å være økende. Sakene har til felles at saksøkerne, foruten å påberope ulovfestet objektivt ansvar eller oppreisningsbestemmelsen i skadeserstatningsloven (ski.) § 3-5, anfører at staten er forpliktet etter EMK til å tilkjenne erstatning for øko­nomisk og ikke-økonomisk tap på objektivt grunnlag ved krenkelser av konvensjonen, og at EMK utgjør et selvstendig erstatningsgrunnlag i norsk rett. Artikkelen vil se nærmere på begge spørsmålene.(...) AVSLUTTENDE BEMERKNINGER Ved å anvende artikkel 13 direkte som erstatningsgrunnlag vil norsk rett klart tilby et effektivt botemiddel. En direkte tillempning av artikkel 13 er likevel ikke den eneste eller nødvendigvis den beste måten å overholde konvensjonen på. Artikkel 13 er ikke utformet med sikte på å være en nasjonal erstatningshjemmel, og tilbyr ikke noen hel­hetlig erstatningslære. (...) Lov og Rett 05 / 2017 (Volum 56)Side: 299-317.)

Lawsuit Blames Stop-Smoking Drug for Pennsylvania Killings
pharmpro.com 10.5.2011
PITTSBURGH (AP) — The fathers of two people killed in a western Pennsylvania murder-suicide say a smoking cessation drug is to blame.

Thirty-four-year-old Sean Wain fatally shot his 33-year-old wife, Natalie, before shooting himself in Economy, Beaver County, in May 2009. A lawsuit filed by their fathers on behalf of the couple's four surviving children says Sean Wain's hostility and rage was prompted by the drug Chantix, marketed by Pfizer Inc.

The drug company did not immediately comment on the lawsuit filed Monday in U.S. District Court in Pittsburgh. But a web site for the drug warns it can cause "hostility, agitation, depressed mood, suicidal thoughts or actions" in some people.

The lawsuit says New York-based Pfizer didn't sufficiently warn consumers until after the murder-suicide, even though those side effects were allegedly revealed during clinical trials of the drug. (...)

Adverse Rx Drug Effects on Increase (Uheldige effekter fra reseptbelagte legemidler øker)
medpagetoday.com 14.4.2011
The number of hospitalizations due to side effects from drugs -- including accidental overdoses -- increased by more than 50% in five years, government researchers found.
In-hospital treatment of adverse events due to hormones -- particularly corticosteroids -- topped the list in 2008, accounting for about 16% of hospitalizations, Jennifer Lucado, MPH, and colleagues reported in an Agency for Healthcare Research and Quality statistical brief.

When combining both hospitalizations and treat-and-release situations, corticosteroids again accounted for most of the adverse events (9.4%), followed by anticoagulants and then antineoplastic and immunosuppressive drugs. (...)

Taken separately, adverse drug events were culprits in 1.8 million hospital stays and 838,000 treat-and-release emergency department visits in 2008.

Stays that year, which accounted for nearly 5% of all hospital stays, increased 52% from 1.2 million stays in 2004.

The mean age of hospitalized patients was 62.8 years, but fell to around 50 when the researchers looked just at poisonings. (...)

(Anm: Medication-related adverse outcomes in U.S. hospitals and emergency departments, 2008. AHRQ Brief 2011 (April).)

Vaccine manufacturers cannot be sued over design defects, US Supreme Court rules
BMJ 2011; 342:d1292 (25 February)
The US Supreme Court has ruled by a 6-2 majority that vaccine manufacturers cannot be sued over claims of design defects in their products.

The court was ruling on a case brought by the parents of a child who developed seizures after a routine diphtheria-pertussis-tetanus (DPT) vaccination (Bruesewitz v Wyeth Inc). It ruled that an act passed by Congress in 1986, which set up a no fault scheme to compensate any child injured by vaccine side effects, bars lawsuits against vaccine manufacturers. (...)

Vaccine Producers Victorious in Supreme Court Ruling Over Lawsuits
pbs.org 22.2.2011
(...) A 6-2 ruling from the U.S. Supreme Court today makes it tougher for parents who say their children were injured by vaccines to file lawsuits against drugmakers. (...)

Lawyers in Vioxx case closer to getting paid
reuters.com 18.2.2011
Feb 18 (Reuters Legal) - After battling Merck & Co. (MRK.N) in court for years over the safety of its Vioxx painkiller, lawyers for the plaintiffs are a step closer to finally getting paid. A committee charged with divvying up more than $300 million in attorneys' fees for work on lawsuits against the pharmaceutical company has made its recommendations to a federal judge in New Orleans.

The recommendations were laid out in a little-noticed court filing last month to U.S. Judge Eldon Fallon of the Eastern District of Louisiana, who has been overseeing the multidistrict litigation over Vioxx. The big proposed winners include the law firms Seeger Weiss ($40.9 million); Beasley, Allen, Crow, Methvin, Portis & Miles ($40.9 million); Herman, Herman, Katz & Cotlar ($32.5 million); Lanier Law Firm ($27 million); and Weitz & Luxenberg ($20 million).

After it won 11 of 16 trials, Merck agreed in November 2007 to settle nearly all of its litigation over Vioxx for $4.85 billion. Since then, nearly all of the plaintiffs have received their funds, but their lawyers have yet to be paid. (...)

Louisiana AG sues GlaxoSmithKline over Avandia
forbes.com 17.2.2011 (Associated Press)
BATON ROUGE, La. -- Louisiana Attorney General Buddy Caldwell is suing British drug maker GlaxoSmithKline PLC, claiming the company hid harmful side effects of the diabetes drug Avandia.

The lawsuit, filed in civil district court this week, accuses Glaxo of illegally marketing, pricing and promoting Avandia and violating Louisiana's consumer protection and unfair trade practices laws. (...) Louisiana AG sues GlaxoSmithKline over Avandia
forbes.com 17.2.2011 (Associated Press)
BATON ROUGE, La. -- Louisiana Attorney General Buddy Caldwell is suing British drug maker GlaxoSmithKline PLC, claiming the company hid harmful side effects of the diabetes drug Avandia.

The lawsuit, filed in civil district court this week, accuses Glaxo of illegally marketing, pricing and promoting Avandia and violating Louisiana's consumer protection and unfair trade practices laws. (...)

Arkansas High Court: Pharmacy Not Liable for Prescription Drug Mix
insurancejournal.com 17.2.2011
The Arkansas Supreme Court has upheld a lower court ruling that a pharmacist has no duty to warn a customer about a dangerous mix of prescription medicines or to inquire about physicians who prescribe them, in a case that involved a doctor later convicted of attempted murder in a separate matter.

Kevin Allen Curry was found dead in his home in Dardanelle, Arkansas on Aug. 24, 2005, according to court records. Following an autopsy, his cause of death was ruled “mixed drug intoxication” combined with alcohol.

The administrator of his estate had sued the pharmacy that dispensed the drugs, and then appealed the lower court’s decision that the dispensing pharmacy, Rose Drugs of Dardanelle Inc., “had no general duty to warn, to not fill dangerous prescriptions, and to inquire of a prescribing physician.” (...)

Paxil Lawsuit: Fitts Zehl LLP Set to Try 5 Paxil Birth Defects Cases in May 2011
marketwire.com 15.2.2011
HOUSTON, TX--(Marketwire - February 15, 2011) - Fitts Zehl LLP -- a personal injury and pharmaceutical litigation law firm in Houston, Texas -- is set to try five Paxil birth defect cases against GlaxoSmithKline (GSK), the second largest drug manufacturer in the world, in Philadelphia state court May 2011. In addition to preparing for trial, the firm is accepting new cases from law firms and clients throughout the United States.

"We've taken steps to ensure that no other Paxil trials take place before our May trials," said Ryan Zehl, Paxil birth defects lawyer and Fitts Zehl LLP partner. "This will be the third time GSK goes to trial over Paxil since the FDA required them to disclose the increased risk of congenital heart defects in babies born to mothers taking Paxil during the first trimester of pregnancy in December 2005." (...)

- Sexgal av Parkinsonmedisiner
vg.no 10.2.2011
SEXAVHENGIG: Didier Jambert, her sammen med kona i rettssalen i Nantes i Frankrike, fikk svært kraftige bivirkninger av medisinen mot Parkinsons sykdom.

Medisinen skulle hjelpe mot Parkinsons. I stedet hevder tobarnsfaren (51) at han ble både spillegal og sexavhengig.

Nå krever Didier Jambart fra Nantes i Frankrike rundt fire millioner kroner i erstatning fra legemiddelgiganten GlaxoSmithKline.

Ifølge nyhetsbyrået AFP hevder 51-åringen at medisinen Requip fikk ham hektet på gambling, uhemmet homofil sex og gjorde ham suicidal. (...)

Kjent effekt
Medisinsk direktør Olav Flaten i GlaxoSmithKline sier til VG at både spillegalskap og hyperseksualitet er kjente bivirkninger for Requip og lignende preparater.

- Dette er en mindre vanlig eller sjelden bivirkning, sier Flaten. (...)

Vermont to Receive $136,000 Settlement in Paxil Side Effects Case
lawyersandsettlements.com 29.1.2011
Montpelier, VT: Vermont's attorney general has announced that the state will receive $136,000 as part of a settlement with drugmaker GlaxoSmithKline over Paxil side effects allegations, among others. (...)

Glaxo Suit on Avandia Heart Attack Death Settled on Trial's Eve (Glaxo-søksmål om dødsfall grunnet hjerteinfarkt utløst av Avandia forliket like før rettssaken skulle starte)
bloomberg.com 31.1.2011
GlaxoSmithKline Plc said it settled on the eve of trial a lawsuit alleging its Avandia diabetes drug caused a North Carolina man to die of a heart attack, avoiding a jury determination over risks associated with the medicine.

The U.K.’s biggest drugmaker resolved the suit by the family of James Burford, an Avandia user who died in 2006. The company declined to provide details of the accord’s terms. The resolution eliminates the risk Glaxo would face a large jury award, said Navid Malik, a drug-industry analyst at Matrix Corporate Capital in London.

Investors worried it “could lead to substantial punitive damages,” Malik said in a Jan. 25 interview. The company has already agreed to pay almost half a billion dollars to resolve claims it hid the drug’s health risks. “GSK needs to successfully settle as many of these cases as possible.” (...)

GSK set aside $3.4bn in last quarter of 2010 to cover legal costs (GSK avsette 3,4 milliarder dollar i siste kvartal 2010 for å dekke rettslige omkostninger)
BMJ 2011; 2011; 342:d488 (24 January)
GlaxoSmithKline has set aside $3.4bn (£2.1bn; €2.5bn) to cover legal costs in the fourth quarter of last year. That amount wipes out the company’s profit for the fourth quarter, the news agency Reuters has reported. However, a GSK spokeswoman said that she could not give sales projections as they would be reported on 3 February.

In July the company set aside $2.36bn to cover costs related to product liability cases settled or received at that time and other problems, bringing the company’s legal costs for the year to $5.8bn.

The costs are related to litigation over its antidiabetes drug rosiglitazone (marketed as Avandia); the company’s sales and promotion practices concerning several drugs, including paroxetine (Paxil) and bupropion (Wellbutrin); and practices at a former manufacturing plant in Puerto Rico. (...)

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

(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).)

Røykestoppmedisin kan forårsake selvmord
nrk.no 7.1.2011
Røykeavvenningspreparatet Champix, som også er i bruk i Norge, kan ha forårsaket over 100 selvmord bare i USA. Nå kan produsenten vente et massesøksmål.

Champix produseres av legemiddelgiganten Pfizer og er i bruk i over 90 land, også i Norge.

I USA, der tablettene selges under navnet Chantix, er det hele sju millioner som bruker det reseptbelagte legemiddelet som kom på markedet i 2006. (...)

Chantix Suicide Lawsuit
accidentinjurylawyerblog.com 26.12.2010
A new study underscores the association of Chantix to violent acts, including suicide.

The study, published in the medical journal PLoS ONE, reviewed FDA adverse event reports, finding that Chantix was associated with 408 adverse reports involving violence. This is more than twice any other drug on the market.

This study bolsters what many Chantix lawsuits have alleged: that Chantix causes violence and suicide in a minority of patients. Why does Chantix do this? No one knows for sure. But Chantix increases the release of dopamine or serotonin to the brain which may cause analmous consequences in some patients. (...)

Pharmaceutical industry wins a major victory as class action is refused authorization
lexology.com 13.12.2010
In a unanimous ruling on November 12, 2010, the Quebec Court of Appeal maintained the dismissal of a motion for authorization to institute a class action against GlaxoSmithKline Inc. (...)

Lægechefer begik »alvorlig fejl« i Omniscan-sag
berlingske.dk 7.12.2010
Lægemiddelstyrelsen erkender, at man ved en fejl fjernede advarslen mod kontraststoffet Omniscan.

Da Lægemiddelstyrelsen i 1998 fjernede advarslen mod at bruge kontraststoffet Omniscan på nyrepatienter, begik man en "alvorlig fejl".

Det erkender Lægemiddelstyrelsens direktør Jytte Lyngvig i et svar til indenrigs- og sundhedsminister Bertel Haarder (V).

- Vi er dybt berørte af den ulykkelige situation og de lidelser, som brug af Omniscan har påført både patienter og pårørende, skriver Jytte Lyngvig i et følgebrev til Lægemiddelstyrelsens notat.

Svar på kritik
Notatet fra Lægemiddelstyrelsen er et svar på den skarpe kritik af Lægemiddelstyrelsen, som er blevet rejst i en uafhængig advokatrapport fra advokatfirmaet Kromann Reumert.

Rapporten konkluderer blandt andet, at tre navngivne chefer i Lægemiddelstyrelsen, heriblandt Jytte Lyngvig, har forsøgt at fortie væsentlige oplysninger om den mangelfulde sagsbehandling, da der blev stillet spørgsmål til sagen i Folketinget.

Det har fået politikere fra flere partier til at kræve de tre chefer afskediget.

Lægemiddelstyrelsen afviser imidlertid, at man har tilbageholdt oplysninger i besvarelsen af Folketingsspørgsmål.

- Vi har svaret korrekt og koncist på de stillede spørgsmål, hedder det i følgebrevet fra Jytte Lyngvig. (...)

What Impact Will Paxil Lawsuits Have on Potential Effexor Lawsuits? (Hvilken innflytelse har Seroxat (Paxil)-søksmål på mulige Efexor-søksmål?)
lawyersandsettlements.com 3.12.2010
Seattle, WA: Women who took Effexor while pregnant and had babies with Effexor birth defects might be watching Paxil litigation with some curiosity. Although no lawsuits alleging serious Effexor side effects, such as Effexor heart defects, have been filed, similar antidepressants have been linked to side effects, including persistent pulmonary hypertension of the newborn (PPHN) and congenital heart defects. (...)

Paxil Birth Defect Trial Tossed Out of Court (Søksmål angående Seroxat-fødselsdefekter vrakes av retten)
lawyersandsettlements.com 1.12.2010
Summerville, SC: It was a heartbreaking end to a Paxil birth defects trial in Philadelphia, after a judge ended the proceedings at about the midway point, finding for GlaxoSmithKline (Glaxo), the defendant. The lawsuit, the first Paxil trial to be undertaken since Glaxo agreed in July to settle 800 cases by paying out more than $1 billion, attempted to determine whether Paxil caused a birth defect suffered by Anna Blyth.(...)

The defendant lobbied the presiding judge to dismiss the action, which State Court Judge Gary Glazer did—effectively ending the trial. It is not known if the Blyth family, which was not part of the earlier Glaxo settlement in July, will appeal the verdict.

Bloomberg reported that 15 additional Paxil cases against Glaxo alleging Paxil birth defects are slated for Philadelphia next year. Some birth defects allegedly linked to Paxil have been severe, resulting on occasion in Paxil infant death. (...)

Ny sag om fejlbehandling af 50.000
ekstrabladet.dk 12.11.2010
Patienter kan få erstatning, hvis en langvarig behandling med prednisolon har medført knogleskørhed, fordi lægen har glemt at supplere med kalk og D-vitamin

Danmark er på vej mod en historisk stor sag om forkert behandling af en stor patientgruppe, skriver Dagens Medicin. Det handler om binyrebarkhormonet prednisolon, som nedbryder knoglerne, hvis ikke patienterne får tilskud af kalk og D-vitamin.

Sundhedsstyrelsen har siden 1999 anbefalet, at alle i længerevarende behandling med prednisolon skal knogleskannes og sikres kalk og D-vitamin som supplement. Det er også almen viden for danske læger. Alligevel har lægerne ikke sikret, at en stor patientgruppe har fået kalk og D-vitamin.

50.000 patienter i farezonen
De første 15 patienter har fået tilkendt erstatning på i gennemsnit 440.000 kroner og mange flere kan være på vej. Op mod 50.000 danskere er i en højrisikogruppe, idet de har fået prednisolon i meget lang tid. (...)

(Anm: Prednisolone. Not to be confused with Prednisone. Prednisolone is a synthetic glucocorticoid, a derivative of cortisol, used to treat a variety of inflammatory and autoimmune conditions and some cancers. (en.wikipedia.org).)

(Anm: Data Lacking on Prednisone Use in RA. Glucocorticoid treatment may be the best and worst possible option. (…) "The medical community has been inept at producing a solid evidence base for the proper application of glucocorticoid therapy," stated Frank Buttgereit, MD, of Charité University Hospital in Berlin, and colleagues. (medpagetoday.com 5.1.2017).)

(Anm: Orale steroider (glukokortikoider) linket til 10 ganger økt risiko for diabetes. (Oral steriods linked with ten-fold increased risk of diabetes. (pulsetoday.co.uk 5.5.2016).)

(Anm: Vanlige legemidler, uvanlig risiko? Høyere frekvens av alvorlige problemer etter kortvarig steroidbruk. (Common drugs, uncommon risks? Higher rate of serious problems after short-term steroid use.) (…) Personer som tok legemidlene var mer sannsynlig å brekke et ben, få en potensielt farlig blodpropp eller få en livstruende sykdom som sepsis i månedene etter deres behandling. (…) Selv om bare en liten prosentandel av begge gruppene kom på sykehus for disse alvorlige helsetruslene, viste det høyere antallet blant mennesker som tok steroider bare noen få dager, at det er grunn til forsiktig og til og med bekymringer, sier forskerne. (news-medical.net 14.4.2017).)

(Anm: Glukokortiokoider. Glukokortikoider har et vidt spekter av forbruksområder; og er uunnværlige i behandlingen av mange alvorlige sykdommer. På folkemunne kalles denne typen medisiner ofte "kortison". Det er egentlig ikke helt riktig. Kortison er riktignok et glukokortikoid, men det finnes også mange andre. Glukokortikoider finnes i: Betametason (Celeston Chronodose®). Deksametason (Decadron®). Metylprednisolon (Depo-Medrol®, Medrol®, Solu-Medrol®). Prednisolon. Prednison. Triamcinolon (Kenacort-T®, Lederspan®). Hydrokortison (Solu-Cortef®). Kortison (Cortison®, Cortone®). Disse preparatene er enten tabletter eller injeksjonsvæske som settes med sprøyte. Glukokortikoider finnes også i en rekke salver, kremer, øyedråper, øredråper, nesesprayer, inhalasjonsprayer og stikkpiller. (lommelegen.no 17.9.2004).)

(Anm: Solu-Medrol 40 mg kan gi alvorlige allergiske reaksjoner hos pasienter med melkeproteinallergi. Legemidler med metylprednisolon til injeksjon som inneholder laktose kan forårsake alvorlige allergiske reaksjoner hos pasienter som er allergiske for melkeproteiner. (legemiddelverket.no 28.8.2017).)

(Anm: Fra Wikipedia, den frie encyklopedi. Inhalasjon av glukokortikoider brukes i behandling av
astma. Glukokortikoider er en klasse steroidhormoner som produseres i binyrebarken, karakterisert ved at de kan binde kortisolreseptorer og dermed gi kortisollignende effekter. Begrepet kortikosteroid omfatter både mineralkortikoider og glukokortikoider, men brukes ofte synonymt med glukokortikoid. Det er utviklet en rekke syntetiske glukokortikoider til bruk som legemiddel ved en rekke tilstander. Populært kalles glukokortikoider ofte astma. Glukokortikoider er en klasse steroidhormoner som produseres i binyrebarken, karakterisert ved at de kan binde kortisolreseptorer og dermed gi kortisollignende effekter. Begrepet kortikosteroid omfatter både mineralkortikoider og glukokortikoider, men brukes ofte synonymt med glukokortikoid. Det er utviklet en rekke syntetiske glukokortikoider til bruk som legemiddel ved en rekke tilstander. Populært kalles glukokortikoider ofte steroider, men dette er en upresis vidtfavnende betegnelse som også omfatter flere grupper av forbindelser med helt andre egenskaper.[1][2] (en.wikipedia.org).)

(Anm: Den europeiska läkemedelsmyndigheten EMA har granskat risken för lunginflammation hos KOL-patienter som använder inhalerade kortikosteroider och kan konstatera att risken gäller samtliga läkemedel i denna klass. Det finns inga bevis för några skillnader i risk mellan de olika preparaten. (lakemedelsverket.se 16.5.2016).)

Glaxo Failed to Warn About Paxil Risks, Lawyer Says at Philadelphia Trial (Glaxo unnlot å advare om Seroxat-risiko, ifølge advokat i Philadelphia-rettssak)
bloomberg.com 9.11.2010
GlaxoSmithKline Plc, the U.K.’s largest drugmaker, failed to properly warn consumers that its antidepressant drug Paxil could cause birth defects, a lawyer for the family of an injured teenager told jurors.

Glaxo had research from the 1980s showing Paxil caused deaths among the offspring of animal test subjects and didn’t provide clear warnings about the deaths, Kimberly Baden, a lawyer for Anna Blyth and her family, told a Philadelphia jury today. Baden said the drug caused a narrowing of the aorta leading from the heart of Anna, now 14 years old.

“We believe the evidence will show Paxil caused Anna’s birth defects,” Baden said in opening statements. “We believe the warnings and instructions put out in 1995 weren’t appropriate and reasonable.” (...)

Washington getting $6 million in Glaxo settlement
forbes.com 2.11.2010
OLYMPIA, Wash. -- The state of Washington will receive more than $6 million as it share of a settlement with GlaxoSmithKline PLC over poorly made pills, including the popular antidepressant Paxil.

Attorney General Rob McKenna said Tuesday that about $3 million will be split between the Medicaid program and the state general fund. The rest of the state's portion will be returned to the federal government to cover its share of Medicaid spending on drugs for Washingtonians.

In the settlement announced last week in Boston, the British company agreed to pay $750 million to the federal government and states to resolve allegations about manufacturing problems at its plant in Puerto Rico. (...)

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

GlaxoSmithKline denies it has settled thousands of lawsuits over rosiglitazone (Avandia) (GlaxoSmithKline benekter å ha forliket tusener av søksmål over rosiglitazone (Avandia))
BMJ 2010;340:c3010 (7 June)
GlaxoSmithKline has denied claims that it has settled "thousands" of the lawsuits brought against the company by people who had heart attacks and strokes while taking the anti-diabetic drug rosiglitazone (Avandia).

A company spokeswoman told the BMJ that many settlements, as reported by Reuters (www.reuters.com/article/idUSLDE65029L20100601), which later issued an update, and by other media outlets, did not happen. (...)

GSK settles first Avandia case in USA (GSK forliker første Avandia-sak i USA)
pharmatimes.com 2.6.2010
GlaxoSmithKine has settled the first case in the USA to be brought to trial concerning claims that the firm’s diabetes drug Avandia caused heart attacks and strokes.

A spokeswoman for the company told PharmaTimes World News that the Avandia (rosiglitazone) case that was scheduled for the first trial in state court in Philadelphia (due to begin yesterday) has indeed been settled. She noted that the next case scheduled for trial is in that court and is scheduled for October, noting that GSK “has not settled the multi-district litigation pending in federal court.” (...)

Glaxo settles hundreds of Avandia suits: lawyer (Glaxo forliker hundrevis av søksmål for Avandia, ifølge advokat)
reuters.com 11.5.2010
(Reuters) - GlaxoSmithKline Plc has settled with nearly 700 people who say they suffered harm because they took the diabetes drug Avandia, a lawyer involved with many of the cases told Reuters on Tuesday. (...)

Glaxo Said to Pay About $60 Million in First Avandia Settlement (Glaxo hevdes å ha utbetalt 60 millioner dollar i første Avandia-forlik)
businessweek.com 10.5.2010
May 10 (Bloomberg) -- GlaxoSmithKline Plc has agreed to pay about $60 million in the first settlements of lawsuits alleging the company’s Avandia diabetes drug causes heart attacks and strokes in some users, people familiar with the accords say. (...)

Regulators approved Avandia for sale in the U.S. in 1999 and the medicine tallied annual revenue of $3 billion by 2006, including sales of a combination of Avandia and another drug. (...)

Paxil Off-Label Use to Be Focus of Heart Defects Trial (Fokuserer på undersøkelser av hjertedefekter ved forskrivning av Seroxat (Paxil) utenfor preparatomtale)
lawyersandsettlements.com 18.4.2010
Washington, DC: Paxil manufacturer GlaxoSmithKline (Glaxo) faces hundreds of Paxil lawsuits alleging that the antidepressant causes birth defects. Next up at the plate is Delaney Novak, a little girl born on April 4, 2002 with heart defects. In June, her parents Laura and Derek will contend that misconduct on the part of Glaxo over safety warnings for Paxil caused Delaney’s birth defects. (...)

[READ MORE PAXIL ARTICLES] (LES FLERE SEROXAT-ARTIKLER) (...) Hundreds of Lawsuits Claim Paxil Causes Birth Defects
parentdish.com 11.3.2010
The makers of the antidepressant drug Paxil are facing an increasing number of lawsuits alleging the medication causes birth defects, and one family has already won a settlement of $2.5 million, online investigative news site The Public Record reports. (...)

UBS weighs Glaxo's Avandia liability
forbes.com 5.3.2010
LONDON -- GlaxoSmithKline PLC could be facing liabilities up to $6 billion over personal injury lawsuits relating to its diabetes drug Avandia, UBS analysts said in a note made public on Friday. (...)

Australian court: Vioxx doubled heart attack risk
pharmpro.com 5.3.2010
The once-popular painkiller Vioxx doubled the risk of heart attack and was unfit for consumption, an Australian court ruled Friday, awarding a man leading a class action suit against the drug's maker 287,000 Australian dollars ($259,000) in compensation.

Melbourne Federal Court Judge Christopher Jessup's decision opens the door for claims from 600 other litigants in a lawsuit against U.S. pharmaceutical firm Merck & Co. over its since-recalled drug Vioxx. The painkiller was taken off the global market in 2004 after research showed it raised the risk of heart attacks and strokes. (...)

SSRI Birth Defects Class Action Lawsuit
lawyersandsettlements.com 28.2.2010
SSRI side effects can cause many serious problems for infants, newborns and children. Some studies have linked the use of SSRIs (selective serotonin reuptake inhibitors) while pregnant with birth defects. SSRI birth defects include persistent pulmonary hypertension of the newborn (PPHN—previously called primary pulmonary hypertension of the newborn) and other lung and heart problems that could qualify for class action lawsuit damages. (...)

County files lawsuit against drug giant over diabetes medication
tradingmarkets.com 27.2.2010
Feb 27, 2010 (San Jose Mercury News - McClatchy-Tribune Information Services via COMTEX) -- Claiming that a major drugmaker made billions of dollars on a diabetes medication that caused heart attacks and strokes, Santa Clara County on Friday filed a lawsuit charging a decade of false advertising and seeking compensation on behalf of patients and providers in California.

Although patients have filed many personal-injury
lawsuits against Pennsylvania-based GlaxoSmithKline over its drug Avandia, this is the first governmental lawsuit claiming the drugmaker falsely advertised Avandia's benefits and concealed its risks, according to Tamara Lange, Santa Clara County's lead deputy county counsel.

The county alleges that GlaxoSmithKline earned billions of dollars on Avandia and cited an estimate that the drug caused 60,000 to 200,000 heart attacks, strokes and cardiovascular deaths nationwide from 1999 to 2006. (...)

Antidepressants May Impact Infant Development (Antidepressiva kan ha følger for spedbarns utvikling)
lawyersandsettlements.com 28.2.2010
Denmark: A new study suggests that babies who are exposed to antidepressants prior to birth are slower to reach certain developmental milestones. The study will likely add to the growing controversy about whether or not SSRI antidepressants are safe for pregnant women to use. (...)

AstraZeneca wins judgment in Seroquel lawsuit
finance.yahoo.com 26.5 finance.yahoo.com.2009
Judge excludes causation testimony, rules for AstraZeneca in Seroquel case

DOVER, Del. (AP) -- A Delaware judge on Tuesday ruled in favor of drug maker AstraZeneca PLC in a lawsuit claiming that the company's anti-psychotic drug Seroquel causes diabetes.

In a one-paragraph ruling, Superior Court Judge Joseph Slights III in Wilmington granted the company's request to exclude testimony from a medical expert for Nina Scaife, a Kansas woman who claimed that Seroquel caused her to develop diabetes.

"In the absence of competent expert testimony regarding specific causation, the court has also determined that it must grant the defendants' motion for summary judgment in this case," wrote Slights, who said he would issue a written opinion later.

The case, which had been scheduled to go to trial June 29, marks the third time that a judge has granted summary judgment to London-based AstraZeneca in Seroquel litigation, with no case yet having reached trial. (...)

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. (...)

Wyeth Supreme Court Loss Breaks Drug Lawsuit Logjam (Update1)
bloomberg.com 30.4.2009
April 30 (Bloomberg) -- Just two months after the U.S. Supreme Court decided patients can sue drugmakers over injuries from medicines approved by the government, long-stalled lawsuits against GlaxoSmithKline Plc and Bristol-Myers Squibb Co. are again moving toward trials.

The March 4 decision in a case on Wyeth’s nausea treatment Phenergan broke a logjam of cases in state and federal courts. Federal regulatory approval of a medicine and information about side effects doesn’t shield drugmakers from claims that patients and doctors weren’t adequately warned, the high court ruled. The decision already affected more than 250 lawsuits involving at least 10 companies that were in limbo before the ruling. (...)

Glaxo this month settled two cases on claims its antidepressant Paxil can make patients suicidal, after judges set trials citing the Wyeth decision. A Barr Pharmaceuticals hyperactivity-drug case is to be tried in August in federal court in Tallahassee, Florida. And a group of Bristol-Myers lawsuits over the blood-thinner Plavix may now proceed to trial in federal court in Trenton, New Jersey.

The Supreme Court decision may cost the industry “billions of dollars,” said attorney Mark Herrmann at Jones Day in Chicago, who defends companies in similar suits. “There’s no way to quantify it, but the number has as many zeroes in it as attacked Pearl Harbor.” (...)

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. (...)

Use of Antidepressants May Increase Risk of Heart Problems in Women, New Study Finds (Bruk av antidepressiva kan øke risiko for hjerteproblemer hos kvinner)
attorneyatlaw.com (14.3.2009)
Drugs for the treatment of severe depression, which are prescribed to tens of millions of Americans each year, may increase the risks of sudden cardiac death and fatal heart disease in otherwise healthy women, according to medical researchers.

The family of drugs called selective serotonin reuptake inhibitors, or SSRIs, includes popular names like Prozac, Lexapro, Zoloft, and Paxil. They are part of a booming pharmaceutical industry and generally considered to be safer and more effective than first-generation anti-depressants, called tricyclic antidepressants. (...)

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

High court revives Paxil, Zoloft suits
philly.com 10.3.2009
The U.S. Supreme Court yesterday gave life to two lawsuits faulting Pfizer Inc. and a GlaxoSmithKline P.L.C. unit for failing to warn that their antidepressants might cause suicidal tendencies in adults.

The justices told the U.S. Court of Appeals for the Third Circuit in Philadelphia, which had rejected the suits, to reconsider them in light of last week's Supreme Court decision giving patients more ability to sue drugmakers.

The antidepressant suits are being pressed by relatives of a woman who killed herself after taking Glaxo's Paxil and a man who committed suicide after taking Pfizer's Zoloft. (...)

Stamford attorney who went on rampage sues psychiatrist
stamfordadvocate.com 3.3.2009
Lawyer was not guilty by reason of mental disease

STAMFORD -- A Stamford attorney who went on a rampage in 2007, shooting at a van driver then breaking into his ex-wife's home, has filed a lawsuit against his psychiatrist.

Eric Witlin, 41, was found not guilty by reason of mental disease or defect in May. In July, he was committed to serve 20 years in the Whiting Forensic Institute after psychiatrists testified that he had a psychotic episode induced by a prescription drug.

The suit was filed Feb. 26 in state Superior Court in Stamford against Dr. Simon Epstein. (...)

The psychiatrists who testified in court said the prescription drugs Adderall and Prozac led to Witlin's state, and one of the psychiatrists said he believed Witlin was misdiagnosed when he was prescribed them.

The psychiatrists and police officers testified that Witlin's Manhattan co-workers noticed increasingly odd behavior immediately. (...)

Drug Approval Is No Legal Shield, Justices Rule (Legemiddelgodkjenning er ikke rettslig skjold mot søksmål, ifølge domstolkjennelse)
nytimes.com 4.3.2009
WASHINGTON — In a major setback for business groups that had hoped to build a barrier against injury lawsuits seeking billions of dollars, the Supreme Court on Wednesday said state juries may award damages for harm from unsafe drugs even though their manufacturers had satisfied federal regulators. (...)

Tvist om diabetesrisk med Seroquel i USA
lakemedelsvarlden.se 2.3.2009
Astrazenca är föremål för en omfattande granskning med anledning av sitt antipsykotika läkemedel Seroquel i USA. Enligt dokument som nyligen offentliggjorts kan företaget ha undanhållit information om risker med preparatet.

IFRÅGASATT Över 9000 rättstvister väntar Astrazeneca i USA efter att patienter har stämt företaget för att det antipsykostiska preparat Seroquel (quetiapin)ska ha orsakat dem skador och gett dem diabetes. I samband med en av domstolsförhandlingarna i Florida har ett stort antal dokument som tidigare varit hemliga offentliggjorts.

I dokumenten finns uppgifter om att Astrazeneca visste om riskerna med diabetes och viktproblem långt innan varningarna placerades ut på förpackningarna. Seroquel godändes i USA 1997 och redan då fanns diabetes med bland biverkningarna men det var först 2003 som information om risken förstärktes, på begäran av det amerikanska läkemedelsverket FDA. (...)

Glaxo Warns of a Charge, Hints at Pact
online.wsj.com 30.1.2009
GlaxoSmithKline PLC warned that its 2008 earnings will be hit by a $400 million legal charge, in a sign that the pharmaceutical company could be approaching a settlement in a five-year-old federal investigation into marketing of antidepressants and other drugs.

Glaxo said the charge was related to the ongoing investigation, which is looking at "marketing and promotional practices for several products for the period 1997 to 2004." Those products include the antidepressants Wellbutrin SR, according to the company; Paxil is another, according to people familiar with the matter. (...)

Dansk massesøgsmål mod Vioxx producent
gigtforeningen.dk 5.11.2008
Der planlægges nu et massesøgsmål i Danmark mod medicinalfirmaet Merck & Co, der i 2004 måtte trække gigtmedicinen Vioxx (den første såkaldte COX-2 hæmmer) tilbage fra markedet pga. alvorlige bivirkninger. Fristen for at anlægge retssagen er allerede d. 25. november 2008. Derfor skal patienter, der ønsker at deltage i søgsmålet, hurtigst muligt kontakte advokat Anders Boelskifte, der repræsenterer sagsøgerne.

Baggrunden for søgsmålet i Danmark er, at ca. 70 danske sagsøgere tidligere anlagde et massesøgsmål i USA - via Boelskifte og den amerikanske advokat Rodney Klein. Men i maj måned blev det besluttet at tilbagekalde søgsmålet i USA, for i stedet at anlægge et massesøgsmål i Danmark. (...)

Chantix Suicides Reported with European Version of Drug
aboutlawsuits.com 11.11.2008
Concerns about Chantix suicide side effects first started to emerge in November 2007, when the FDA issued an “Early Communication” about an on-going investigation into at least 39 reports of Chantix suicides and nearly 500 reports of suicidal thoughts and behavior involving the drug in the United States.

Since that time, the FDA has required Pfizer to add a “black box” warning about the psychological side effects of Chantix, and many users who took their own life or suffered severe physical injuries as a result of a suicide attempt are filing Chantix lawsuits against Pfizer for failing to previously warn about the risk associated with the drug. (...)

Grandparents sue makers of Prozac over Friendswood doctor's death
txcn.com 10.11.2008
HOUSTON—A civil trial was set to begin Monday to decide if a pharmaceutical company has any responsibility in the shooting death of a Friendswood doctor. (...)

Staten betalar ut skadestånd för vaccinationsskada
dagensmedicin.se 10.11.2008
En man som skadades när han vaccinerades mot tuberkulos som barn ska få 257 000 kronor i skadestånd från staten. Det har justitiekanslern, JK, beslutat.

Mannen tillhör en grupp på omkring personer som skadades av BCG-vaccin från Danmark på 1970-talet. Han drabbades av en medicinsk invaliditet på 10 procent, enligt nyhetsbyrån TT. Dessutom har han fula ärr på överkroppen.
Mannen fick knappt 5 000 kronor i ersättning från staten redan 1979. Nu har JK beslutat att ge honom ytterligare 257 000 kronor. (...)

Local woman seeks legal action against drug maker
northpeel.com 6.11.2008
A Brampton woman alleges her young son's health problems are directly related to antidepressants prescribed during pregnancy, and is now taking legal action against the drug manufacturer.

Lawyers representing Shannon Cote, 29, and her 10-year-old son, say they have commenced a lawsuit against Glaxo Smith Kline, distributors of the drug Paxil.

In a formal statement sent to The Guardian, Glaxo Smith Kline corporate communication officials said the company had not received formal notification of any legal action with respect to this matter. (...)

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

Internal Documents Indicate Two FDA Officials Objected To Rules Aimed at Pre-Empting Lawsuits
kaisernetwork.org 30.10.2008
Two FDA officials objected to rules recently issued by the agency that sought to limit the ability of consumers to file product liability lawsuits against pharmaceutical companies in state courts, according to internal documents released on Wednesday by House Oversight and Government Reform Committee Chair Henry Waxman (D-Calif.), the Wall Street Journal reports (Mundy, Wall Street Journal, 10/30). (...)

According to the documents, two FDA officials in memos said that FDA approval of medication labels are not completely reliable or based on full disclosure of safety risks by pharmaceutical companies. The "internal documents also revealed that the White House played a significant role in drafting the industry-friendly rules" in support of pre-emption, CongressDaily reports (CongressDaily, 10/29). (...)

Congressional Report Lays to Waste Bush Administration’s Pre-emption Claims
citizen.org 29.10.2008 (Public Citizen)
A report issued today by the House Oversight and Government Reform Committee is proof that the Bush administration has pulled out the stops to shield drug companies from liability for dangerous drugs while leaving patients out in the cold. The report, based on documents obtained from the Food and Drug Administration (FDA), concludes that the agency’s efforts to protect drug companies delayed the dissemination of important safety information to the public. The documents reveal that top FDA officials who deal with drug safety on a day-to-day basis do not believe that lawsuits undermine consumer safety, but their views were overridden by political appointees who lacked any empirical support for their views.

It’s bad enough that politics consistently trumps science with this administration. But here we have clear documentation of how the White House hijacked an agency and forced it to undermine its own mission, which is to protect patients. (...)

Pfizer Finalizes $60M Settlement With States Over Off-Label Marketing of COX-2 Inhibitors
kaisernetwork.org 23.10.2008
Pfizer on Wednesday said it will pay $60 million to 33 states and Washington, D.C., to settle lawsuits that claimed the company promoted the COX-2 inhibitors Bextra and Celebrex for unapproved uses, the Miami Herald reports. The agreement is part of an $894 million settlement that the company announced last week to cover more than 90% of pending lawsuits involving the drugs. The settlement also includes $745 million to settle personal injury claims and $89 million for consumer fraud claims brought by insurers and consumers seeking to recoup money spent on the drugs.

COX-2 inhibitors drew increased scrutiny when Merck in 2004 withdrew its COX-2 inhibitor Vioxx from the market because of a link to cardiovascular risks. Celebrex is the only remaining COX-2 inhibitor on the market. (...)

Pfizer settles Celebrex and Bextra lawsuits
pharmatimes.com 17.10.2008
Drug giant Pfizer has reached an $894 million agreement to resolve almost all of the lawsuits regarding its pain drugs Bextra (valdecoxib) and Celebrex (celecoxib).

The drugmaker has been embroiled in numerous court battles with patients claiming to have suffered cardiovascular events after taking COX-2 inhibitors Bextra, which was withdrawn from the US market in 2005 on safety grounds, and Celebrex.

The announcement follows favourable rulings which saw federal and New York court judges decide that a majority of the personal injury cases failed to present reliable scientific evidence to prove Celebrex can cause heart attacks or strokes at its most commonly prescribed dose. (...)

J&J pays out $68.7 million to settle birth-control suits
pharmatimes.com 13.10.2008
Johnson & Johnson has paid out more than $68 million to settle hundreds of lawsuits by women who allege they have been harmed by the company’s contraceptive patch Ortho Evra, it has been reported.

Documents obtained and reviewed by Bloomberg News detail that the drug giant spent at least $68.7 million settling lawsuits claiming Ortho Evra (norelgestromin/ethinyl estradiol transdermal system) caused blood clots, heart attacks and stroke. The patch has also been linked to the deaths of 20 women, while studies have showed the patch doubles the risk of blood clots compared with the pill.

According to the documents, J&J did not go to trial but rather settled the suits privately and failed to release the financial details to investors. (...)

Malpractice case alleges prescription of drug for off-label use caused permanent disability
setexasrecord.com 8.9.2008
A Beaumont man has filed a suit against a local psychiatrist, alleging the doctor prescribed a medication for an off-label use that has left him permanently disabled. (...)

"Tardive dyskinesia is characterized by repetitive, involuntary, purposeless movements. Features of the disorder may include grimacing, tongue protrusion, lip smacking, puckering and pursing, and rapid eye blinking. Rapid movements of the arms, legs, and trunk may also occur. Involuntary movements of the fingers may appear as though the patient is playing an invisible guitar or piano." (...)

The suit says that Moss was initially diagnosed with facial spasm and Parkinsonism and was referred to a neurologist at the Baylor College of Medicine in January 2007.

The specialist diagnosed Moss as having "tardive blepharospasm and tardive dyskinesia induced by Geodon and Zoloft," the suit states.

Zoloft is a commonly prescribed medication used to treat depression. Before being referred to Bagri, Moss had tried Zoloft, Risperdal, Diazepam, Lexapro and other anti-depression and anti-anxiety medications while under the care of his primary physician.

However Moss' attorney, Ken Lewis, wrote in the complaint that the neurologist at Baylor who diagnosed the side effects as "induced by Geodon and Zoloft" did not have the benefit of the actual medical records and prescription records.

According to the suit, the records showed that Moss "had not taken Zoloft for more than a year before his neurological symptoms developed and could not have been a contributing cause." (...)

(Anm: Blefarospasme; blepharospasmus, krampeliknande attkniping av augelokka; sjå dystonia cranialis (e.n. kneppauga) EN blepharospasm. Kilde: Norsk medisinsk ordbok.)

(Anm: dystonia; dystoni; endring i muskulaturens spenningstilstand, ofte i form av ufrivillige muskelsammentrekninger (f.eks. i nakkemuskulaturen og svelgmuskulaturen. Dystoni kan være symptom ved indremedisinske og nevrologiske sykdommer, men kan også opptre som bivirkning av legemidler som blokkerer signalsubstansen dopamin. Akutte dystonier sees hos yngre menn noen dager etter at vedkommende har begynt på relativt høye doser med nevroleptika. (...) Ved akutte dystonier på grunn av legemidler er behandlingen tilførsel av antiparkinsonmidler. Kilde: Store norske leksikon.)

(Anm: Kvinner har oftere kjeveproblemer. Kan gi hodepine, svimmelhet, øresus og smerter i nakke og skuldre. (…) I følge en artikkel publisert på nettstedet 1-800-dentist, en av USAs største tannlegenettsider, kan problemer med kjeven - også kalt temporomandibular joint syndrome (TMJ) også skyldes: (kk.no 1.12.2015).)

Baum, Hedlund, Aristei & Goldman Achieves 3rd Preemption Win This Year on Behalf of Their Clients in Paxil Suicide Case
expertclick.com 3.9.2008
A federal judge in Pennsylvania ruled on Friday, August 29, 2008, that a lawsuit filed by the parents of a 16-year-old New Jersey boy who committed suicide while taking Paxil is not preempted by federal law, as Paxil’s manufacturer, GlaxoSmithKline (GSK), had hoped. (...)

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

Editorial Addresses NEJM Commentary on Pre-Emption
kaisernetwork.org 25.8.2008
A Las Vegas Sun editorial agrees with the editors of the New England Journal of Medicine "who say that taking away consumers' right to sue would also take away a strong incentive for the FDA and the pharmaceutical industry to be open about a drug's potential for causing harm." According to the editorial, the NEJM editors "state the obvious" that FDA and the pharmaceutical companies "haven't always been completely open or correct in their labeling, even when the risk of lawsuits has been present." The editorial concludes, "Preserving the right of consumers to sue will keep federal agencies and manufacturers more honest -- and the public more protected" (Las Vegas Sun, 8/23). (...)

Sun Editorial:
Protecting the consumer

lasvegassun.com 23.8.2008
Federally approved labels should not serve as legal immunity for manufacturers

Many of the recent criticisms of the Food and Drug Administration have been directed toward one of the agency’s most important responsibilities: determining whether prescription drugs are safe before they are allowed on the market.

It is within this context that a case to be heard by the U.S. Supreme Court in November is attracting attention, including from the editors of the New England Journal of Medicine. (...)

New FDA labeling rule could be lawsuit shield (Nye FDA regler for preparatomtaler kan være skjold mot søksmål)
money.cnn.com 22.8.2008
FDA rule on drug labeling attracts praise from drugmakers, ire from lawyers

NEW YORK (Associated Press) - Government regulators have issued new rules designed to keep drug warning labels clear and concise, though some say the new guidelines would also shield drugmakers from lawsuits.

The regulations from the Food and Drug Administration, which were released Thursday and take effect next month, explain when drug and medical device companies are responsible for rushing out safety updates on their products.

The Pharmaceutical Research and Manufacturers of America welcomed the announcement, saying it provides much-needed clarity. But trial lawyers who represent consumers said it will provide legal protection to companies that withhold information on their products' risks. (...)

Doctors: Lawsuits help guarantee drug safety (Leger: Søksmål bidrar som garantist for legemiddelsikkerhet)
usatoday.com 15.8.2008
WASHINGTON (AP) — Top doctors who run one of the most influential U.S. medical journals are giving the U.S. Supreme Court some unsolicited legal advice about a major case.

Lawsuits can serve as "a vital deterrent" and protect consumers if drug companies do not disclose risks to the U.S. Food and Drug Administration before it approves medicines for use, the editors of the New England Journal of Medicine said in a friend-of-the-court brief. The FDA "is in no position" to guarantee drug safety, the brief said.

At issue is Wyeth v. Levine, a case expected to be heard late this year that could have far-reaching implications for litigation over allegedly harmful drugs, such as the painkiller Vioxx. (...)

Litigators Set Sights on Chantix
fdanews.com 15.7.2008 (FDAnews Drug Daily Bulletin)
A lawsuit claiming Pfizer’s smoking-cessation drug Chantix caused a suicide was filed in Indiana federal court earlier this month, and a major law firm is investigating similar legal action against the manufacturer. (...)

Former nurse sues GP for up to £100k
northamptonchron.co.uk 12.7.2008
A former practice nurse, allegedly left in "a zombie-like state" when a disgraced doctor prescribed her nine different drugs, is suing him for up to £100,000 damages.

Solicitors acting for Jacqueline Timson, 46, have issued a High Court writ against Dr Desmin O'Callaghan, who was struck off two years ago for a campaign of hate against a village vicar. (...)

Drug company asks judge to throw out $215M verdict
forbes.com 10.6.2008
MONTGOMERY, ALA. - Associated Press Attorneys for drug manufacturer AstraZeneca Pharmaceuticals LP asked a judge Monday to throw out or reduce a $215 million jury verdict in a Medicaid drug price fraud lawsuit. (...)

Kim Harris, an attorney for the subsidiary of Britain's AstraZeneca PLC, argued the state did not prove AstraZeneca purposely caused Alabama's Medicaid system to pay too much for drugs prescribed to low-income state residents.

Harris also argued the law allows plaintiffs to receive punitive damages that are no more than three times that of compensatory damages. The circuit court jury ordered $40 million in compensatory damages and $175 million in punitive, an amount Harris said went beyond the formula. (...)

Mother sues doctor over daughter's antidepressant
theage.com.au 21.3.2008
A MOONEE Ponds mother is suing her 16-year-old daughter's doctor for prescribing the teenager antidepressants linked to suicidal tendencies.
The woman has told the Victorian Civil and Administrative Tribunal that her daughter, an A-grade student, became violent and tried to commit suicide twice after she was prescribed Zoloft for depression last August.

In a statement of claim to the tribunal, the mother said Dr Vanessa Heler, of the Peninsula Women's Health group, Mornington, gave her daughter the drug despite its lack of approval from the Therapeutic Goods Administration for children under 18. (...)

Baum Hedlund Wins Key Preemption Ruling in Collins Paxil Suicide Case
baumhedlundlaw.com 18.3.2008
On March 12, 2008, a Philadelphia judge denied Paxil manufacturer, GlaxoSmithKline’s (GSK) motion to dismiss the claims of a family whose husband and father committed suicide while taking Paxil, in Collins v. SmithKline Beecham, d/b/a GlaxoSmithKline. The Honorable Allan L. Tereshko, Coordinating Judge, Complex Litigation Program, in the Court of Common Pleas, First Judicial District of Pennsylvania, Philadelphia County, denied GSK’s motion for summary judgment on Federal Preemption grounds. Judge Tereshko stated in his order that he "rejects Defendant’s theory of preemption for a number of reasons." (...)

Mother Sues Drug Company (Mor saksøker legemiddelfirma)
cknw.com 1.3.2008
VANCOUVER/CKNW(AM980) - A Surrey woman and her infant daughter are launching a class-action lawsuit against the manufacturer of a commonly-used anti-depressant medication.

Faith Gibson alleges drug company Glaxo-Smith-Kline didn't adequately warn of the potential side effects for pregnant women taking the drug Paxil. (...)

Lawsuit Filed Against GlaxoSmithKline by Heart Bypass Patient
lawyersandsettlements.com 16.2.2008
Philadelphia, PA: On February 12, 2008, a lawsuit was filed in the U.S. District Court for the Eastern District of Pennsylvania by Pat and Sandra Kelly of Grove, Oklahoma against GlaxoSmithKline, the maker of the poplar diabetes drug, Avandia. The lawsuit states that GSK was negligent, committed fraud, breached its warranty, failed to warn about the risks associated with the drug, and neglected pharmaco-vigilance. The plaintiffs state that these factors led to the serious injury of Mr. Kelly. (...)

Drugmaker Sued Over Diabetes Pill
money.cnn.com 14.2.2008
NEW YORK (Associated Press) - An Oklahoma man is suing drugmaker GlaxoSmithKline in federal court, claiming its popular diabetes pill gave him heart problems that required bypass surgery.

Attorneys for Grove residents Pat and Sandra Kelly allege in the lawsuit that the drugmaker should have known that Avandia was associated with a significant increased risk of heart failure, heart attack and stroke, among other side effects. (...)

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. (...)

King & Spalding Earns Victory in Products Liability Case for GlaxoSmithKline
infobolsa.es 1.2.2008
GlaxoSmithKline 01/02/2008 17:25:00 Business Wire King & Spalding, a leading international law firm, has earned a significant victory for client GlaxoSmithKline ("GSK") in a products liability case.

On January 30, a federal district judge granted summary judgment in O Neal v.
SmithKline Beecham d/b/a GlaxoSmithKline and dismissed, with prejudice, all claims made by the plaintiff in a case involving the 1997 suicide of a 13 year-old

This is the fourth major win in a series of victories over the past several months regarding suits filed against the drug manufacturer of the antidepressant drug Paxil. (...)

Suit Alleges More Health Problems
From Merck's Fosamax Drug

online.wsj.com 28.1.2008
A Connecticut woman has sued Merck & Co., claiming that its osteoporosis drug Fosamax caused multiple stress fractures and suppressed bone regeneration in her legs. JoAnn Moranski of Fairfield alleges in a complaint filed in New Jersey state court that she took the drug from 1996-2006.

More than 400 people already have sued Merck alleging that Fosamax causes a bone-wasting condition known as osteonecrosis of the jaw.

Fosamax, which loses its patent protection in the U.S. next month, generated sales of nearly $3 billion in 2007. (...)

Personskador inom psykiatrin leder sällan till ersättning
Läkartidningen 2008;105:39-41
(...) Medicineringsskador
Enligt Patientskadelagen kan ersättning bli aktuell endast om förskrivning av läkemedel inte har skett enligt föreskrifter och anvisningar och om de uppkomna besvären har ett samband med sådana brister. (...)

Psykofarmaka.
Flera psykofarmaka, särskilt vissa antipsykosmedel, ger ibland mycket stor viktuppgång, även åtföljt av diabetes. (...)

Tandskador. Flera psykofarmaka ger muntorrhet med ökad risk för tandsjukdomar. Sådana skador ersätts inte genom Patientförsäkringen om förskrivningen skett på ett riktigt sätt. (...)

Beroende av bensodiazepiner.
Bensodiazepiner förskrivs fortfarande under långa tider på dåligt vetenskapligt underlag. Risken för utveckling av beroende är väl känd. (...)

Prof. sues over medication (Professor saksøker over legemiddel)
stanford.edu 11.1.2008
David McKay sues over son’s suicide following Prozac purchase from online pharmacy (...)

Nurse’s Family Files Avandia Wrongful Death Lawsuit against GlaxoSmithKline
lawyersandsettlements.com 18.12.2007
Los Angeles, CA: Rogelio Larosa and his adult son, Eric, of National City, San Diego County, California, filed a lawsuit on Monday, December 17, 2007, against Philadelphia-based GlaxoSmithKline ("GSK"), the maker of Avandia (rosiglitazone maleate), in U.S. District Court, Southern District of California (San Diego) accusing GSK of causing the wrongful death of a Chula Vista nurse due to its negligence, fraud, breach of warranty and a failure to warn about the risks of its drug, Avandia. (...)

ATRA's excerpts: Callis credited for Madison County's improvements
madisonrecord.com 18.12.2007
Declining number of lawsuits, fewer class actions, dismissals of out-of-state asbestos cases and positive changes in the handling of medical liability cases are reasons the American Tort Reform Association gives for moving Madison County, and St. Clair County, off its "Judicial Hellhole" list.

The annual report released on Tuesday moved both jurisdictions ATRA claims are "joined at the hip" onto its "Watch List." (...)

Mom files class-action suit
canada.com 5.10.2007
A Vancouver mother has launched a class-action lawsuit claiming the anti-depressant Paxil caused her daughter's heart defect. (...)

The action must be certified before it can go ahead. GlaxoSmithKline, the U.K.-based maker of Paxil, has two weeks to respond to the writ, which claims unspecified damages.

In September 2005, the U.S. Food and Drug Agency issued a warning that detailed the results of a study linking Paxil to birth defects after an increased number of women taking Paxil during the first trimester of pregnancy had babies born with birth defects, including heart problems. (...)

Drug Makers Must Warn Patients of Risks, WV Justices Rule
healthdecisions.org 29.6.2007
Drug companies cannot escape liability for harmful prescriptions in West Virginia by laying all responsibility on doctors, the West Virginia Supreme Court of Appeals ruled Wednesday.

Three of five Justices denied a writ that would have kept Marshall Circuit Judge Mark Karl from holding trial against Janssen Pharmaceutica. (...)

Lawyers begin move on GlaxoSmithKline over diabetes drug fears
thebusinessonline.com 30.5.2007
LAWYERS have already started to circle GlaxoSmithKline (GSK), the pharmaceuticals giant, after claims last week of problems with its diabetes drug.

The Business has learned that a conference has been set up to co-ordinate the work of lawyers wishing to sue the company over its diabetes drug Avandia. It is being organised as a precursor to what is expected to be a series of class actions.

Analysts have already predicted that legal claims over Avandia could cost the company as much as $5bn (£2.5bn, E3.7bn). Deutsche Bank analysts said last week that legal costs could reach $300,000 per case and Avandia sales would plummet by 35%, cutting GSK’s net income by 7%. (...)

FDA's Pre-emption Rule Splits the Courts
law.com 4.5.2007
Challenges focus on failure-to-warn ban (...)

Vioxx ska granskas igjen
dn.se 18.2.2007
Fler svenska patienter som fått biverkningar av läkemedlet Vioxx kan komma att få ersättning från Läkemedelsförsäkringen. Läkemedelsskadenämnden har tillsatt en arbetsgrupp som ska över de senaste forskningsrönen kring Vioxx biverkningar. (...)

Merck Braces for Flood of Fosamax Lawsuits (Merck forbereder seg på en strøm av søksmål)
consumeraffairs.com 6.2.2007
Legemiddel mot osteoporose (benskjørhet) kan ødelegge pasienters kjeveben (...) (Osteoporosis Medication Can Destroy Patients' Jawbones)

(Anm: Benskjørhet (mintankesmie.no) - Tannleger og tannhelse (munnhulen er kroppens speil) (mintankesmie.no).)

Why you should never trust new wonder drugs
dailymail.co.uk 6.2.2007
A drug company was last week accused of concealing evidence about the safety of the antidepressant Seroxat. According to leading psychiatrist Professor David Healy, this is just the latest in a string of cases where patients and medical professionals have been misled about a drug's adverse effects. (...)

Ny ekonomisk uppgörelse kring Zyprexa
Läkemedelsvärlden 2006(1-2) (FEBRUARI 2007)
Arton tusen personer får dela på femhundra miljoner dollar. Det blev resultatet i den senaste uppgörelsen mellan läkemedelsföretaget Eli Lilly och patienter som behandlats med Zyprexa. (...)

Proposed Settlement to Make $63.8 Million Available for Individuals Who Purchased Paxil(R) or Paxil CR(TM) for Minors
prnewswire.com 21.12.2006
-- All persons in the United States who purchased Paxil(R) or Paxil CR(TM) prescribed for consumption by a minor child may be eligible for relief as part of a $63.8 million Proposed Settlement. The lawsuit alleges that GlaxoSmithKline
("GSK") promoted Paxil(R) or Paxil CR(TM) for prescription to children and
adolescents while withholding and concealing material information about the
medication's safety and effectiveness for minors. GSK denies all claims. (...)

GSK's dirty tricks in competing class actions
fiddaman.blogspot.com 20.12.2006
It was a busy day for lawyers in the Paxil litigation in Madison County on Tuesday as a routine hearing to enforce an injunction branched into three separate, contentious hearings with two judges. (...)

Paxil Suicide Risk (Seroxat og selvmordsrisiko)
boston.injuryboard.com 20.12.2006
Earlier this year, GlaxoSmithKline, agreed to add a new warning to its anti-depressant drug, Paxil, and its controlled release version, Paxil Cr. The generic name for Paxil is paroxetine. (...)

Drug Makers Accused Of Misleading Health Dept.
keyetv.com 18.12.2006
(CBS 42) AUSTIN One of the nations largest drug makers is accused in a lawsuit of misleading the Texas Mental Health Department about the safety and effectiveness of one of its top selling drugs.

The drug in question is the anti-psychotic risperdal. The Texas attorney general joined a whistle-blower lawsuit that could cost the Johnson and Johnson companies more than a billion dollars. (...)

Blood clots can have very serious consequences
thelegalleadsnetwork.com 82006)
Recently the FDA disclosed that the excessive levels of estrogen delivered by the birth control patch Ortho Evra can cause serious injuries and even death to the women who use it. Johnson and Johnson is the parent company of the manufacturer of the Ortho Evra patch.

Especially worrisome is the finding that most of about a dozen users who died of clot-related complications in 2004 were young — in their late teens and early 20s. (...)

Lexapro Legal Problems Mount Against Forest Laboratories
By Evelyn Pringle
lawyersandsettlements.com 15.11.2006
Fair Haven, NJ: According to Forest Laboratories' Annual Report, for the year ending March 31, 2006, Celexa and Lexapro, accounted for 68% of the company's sales.

The drugs belong to the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).

Sales of Lexapro, the filing notes, increased 16% in the 4th quarter to $464,100,000, compared to $399,381,000 in the same quarter a year ago.

However, the Report filed with the SEC on June 14, 2006, also says that Forest Labs is currently a named defendant in approximately 25 active SSRI related lawsuits, with most of the cases claiming that Celexa or Lexapro caused or contributed to persons committing or attempting suicide. (...)

(Anm: Celexa (citalopram); markesføres i Norge under handelsnavn som bl.a. Cipramil; Celexa i USA.

(Anm: Lexapro (ecitalopram); markesføres i Norge under handelsnavn som bl.a. Cipralex; Lexapro i USA.)

Vant sak mot østrogen-pille
mozon.no 19.10.2006
En amerikansk kvinne har fått rettens medhold i at hormonbehandling har skylden for hennes brystkreft. Nå følger tusenvis av liknende rettssaker.

Den amerikanske kvinnen og hennes ektemann ble tilkjent nesten ti millioner kroner i erstatning av juryen i Philadelphia.
Retten mente at det fantes en klar sammenheng mellom hormonpreparatet Premro og at kvinnen måtte gjennom alvorlige operasjoner på grunn av brystkreft. Juryen skal også vurdere om legemiddelselskapet Wyeth må betale bøter for å ha informert for dårlig om de farlige bivirkningene.
Krangler om risikoen
Dette er ikke første gang de store legemiddelselskapene har blitt kritisert for bivirkninger av hormonprodukter.

Medikamentene som inneholder forskjellige kombinasjoner av hormonene østrogen og gestagen, brukes til å redusere symptomene ved overgangsalderen hos kvinner. Preparatene kan samtidig redusere risikoen for benskjørhet, men øker sannsynligvis risikoen for dødelig blodpropp og brystkreft. (...)

Louisiana Man Files Lawsuit Against Eli Lilly Alleging Zyprexa Caused Diabetes
newsinferno.com 19.9.2006
A Louisiana man filed a lawsuit in U.S. District Court against Eli Lilly and Co., claiming he developed diabetes as a result of using the popular atypical antipsychotic drug Zyprexa. The man took Zyprexa for two years and developed severe diabetes. The lawsuit argues that Eli Lilly did not give proper warning that the drug could be linked to diabetes and other serious side effects.

Zyprexa is a leading atypical anti-psychotic drug which is also known as olanzapine. The drug approved by the U.S. Food and Drug Administration in 1996 to treat schizophrenia and bipolar disorder. In 2004, Eli Lilly began including strong warning labels with Zyprexa regarding an increased risk of hyperglycemia and diabetes, especially in patients with a family history of diabetes. In 2005, Eli Lilly agreed to pay plaintiffs $690 million to settle thousands of Zyprexa claims.

Other popular atypical ant-psychotics include Risperdal, Seroquel, Clozaril and Geodon. Risperdal, Seroquel and Clozaril have all been associated with diabetes and other blood sugar disorders. Numerous lawsuits have also been filed against the manufacturers of these drugs. (...)

Court orders J&J to pay Duragesic death damages
pharmatimes.com 10.7.2006
Court orders J&J to pay Duragesic death damages

A US jury has ruled that healthcare giant Johnson & Johnson must pay actual damages of $772,500 to the family of Michaelynn Thompson, who died in 2004 after using the firm's Duragesic painkiller patch.

The family of Ms Thompson claimed that the Duragesic patch she was using was defective, allowing a fatal dose of the active agent fentanyl to leak into her system.

But J&J is adamant that its product is safe. Said company spokesman Mark Wolfe: "We disagree with the outcome of this trial. We are evaluating our legal options," reported the The New York Times.

Others are not so sure. The US Food and Drug Administration launched an investigation last year into the safety of pain-relieving patches that contain the narcotic fentanyl, after they were linked to the deaths of several patients.

The FDA has not specified exactly how many deaths had been linked to the patches, but The New York Times reports that around 120 people have died since Duragesic first won the green light back in 1990. (...)

Zicam Settlement
zicam-cold-eeze-lawyers.com 19.1.2006
January 19, 2006—Matrixx Initiatives has reached a settlement with 340 persons who loss their sense of smell after using Zicam. These cases resolved for $11.9 million plus $100,000 in costs. (…)

Zicam is a popular non-prescription zinc nasal spray. Its manufacturer markets it as a medication to shorten the duration of the common cold.
Zicam has been associated with the onset of a condition known as anosmia, which leaves the user with a potentially permanent loss of smell and taste. These side effects typically are irreversible. The federal Food and Drug Administration (FDA) currently is collecting and evaluating reports of severe reactions to Zicam. (…)

California Vioxx Trial to Open as Drug Litigation Booms
latimes.com 27.6.2006
An explosion in litigation spurs calls for legal reform and regulatory changes. (...)

Update 1: Eli Lilly Posts Q2 Loss on Settlement
Forbes 21.7.2005
INDIANAPOLIS - Drug maker Eli Lilly & Co. said Thursday that it slid to a second-quarter loss from a year-ago profit because of a recent product liability settlement over Zyprexa, its top selling anti-psychotic treatment.

The company posted a quarterly loss of $252 million, or 23 cents per share, compared with a profit of $656.9 million, or 60 cents per share, a year ago. Results included a charge of $1.07 billion or 90 cents per share to settle claims in June that the company failed to provide adequate warnings that Zyprexa could put patients at greater risk of developing diabetes. (...)

U.S. Looking at Marketing by Johnson & Johnson
New York Times 21.7.2005
Johnson & Johnson's aggressive marketing of its heart-failure treatment Natrecor has become the subject of an inquiry by the Justice Department.

The company said yesterday that it had received a subpoena from the United States attorney in Massachusetts, Michael J. Sullivan, whose office is known for its prosecution of health care fraud.

Mr. Sullivan's office would not disclose the reasons for the subpoena, which demanded information about the "sales and marketing" of Natrecor. (...)

Texas sues Merck over Vioxx safety
Houston Chronicle 1.7.2005
State claims the painkiller's maker misrepresented its danger to heart.

Krever erstatning etter Vioxx-bruk
Tidsskr Nor Lægeforen 30.6.2005
Hittil i år har 103 pasienter meldt krav om erstatning for legemiddelskader etter bruk av Vioxx. (...)

Vioxx Lawsuits Could Reach Trial in Fall
ABC 23.6.2005
First Federal Lawsuits Against Merck Over Vioxx (...)

Merck Knew Vioxx Dangers In 2000
ABC 22.6.2005
Merck & Co. researchers privately sought to reformulate Vioxx in 2000 to reduce its cardiovascular side effects, even as the drug maker was publicly playing down a study that highlighted the pain relief medication's potential heart attack risk, an internal company document shows. (...)

Få får skadestånd för Vioxx-komplikationer
Läkemedelsvärlden 2005 (9)
Bara en åttondel av alla anmälningar till Läkemedelsförsäkringen av hjärtinfarkter eller slaganfall med misstänkt koppling till Vioxx som hittills behandlats har lett till utbetalning av ersättning.

VIOXX I mitten av augusti hade 80 anmälningar kommit in till Läkemedelsförsäkringen från patienter som ansett sig ha drabbats av hjärtinfarkt eller stroke som följd av Vioxx-behandling. Av dessa hade 46 behandlats av försäkringsbolaget Zürich som handhar ärendena. Resultatet är hittills 40 avslag och endast sex beslut om utbetalningar av skadestånd.
- Dessutom har ett 30-tal patienter anmält andra krämpor som man kopplat till Vioxx, säger Sonia Engdahl på Zürich.

Av dessa har ingen hittills beviljats ersättning, och enligt Sonia Engdahl är det inte heller troligt att så blir fallet. (...)

Judge denies Pfizer's motion to dismiss Zoloft lawsuit
Star Tribune 21.7.2005
Drug manufacturer Pfizer Inc. had the authority to strengthen warning labels for its Zoloft antidepressant drug and did not need Food and Drug Administration approval to do so, a
federal judge ruled Wednesday in a lawsuit brought by a Minneapolis woman whose husband committed suicide shortly after he began taking the medicine. (...)

ZYPREXA™ PRESS RELEASE
Brown & Crouppen, Attorneys at Law
June 9, 2005, St. Louis, Missouri -- Eli Lilly Agrees to Pay Approximately $700M in Zyprexa Settlement - Brown & Crouppen Poised to Assist Victims

Brown & Crouppen's team of professional lawyers is pursuing claims on behalf of individuals who have taken Zyprexa, an anti-psychotic drug manufactured by Eli Lilly & Co.

Late Thursday, June 9, 2005, Lilly announced that it will settle approximately three-quarters of the liability claims stemming from claims that the label on Zyprexa medication boxes failed to provide adequate warning that the drug could put patients more at risk for developing diabetes.

Zyprexa is the brand name for olanzapine. It is considered an "atypical" antipsychotic medication used to treat Schizophrenia and Bipolar Mania. Approved by the Food and Drug Administration (FDA) in 1996, it is thought that Zyprexa works by decreasing the effects of two chemical messengers in the brain, serotonin and dopamine. (...)

Pharmaceuticals favored despite lawsuits
The Baltimore Sun 26.6.2005
Strong balance sheets, earnings potential win support from analysts (...)

U.S. to Pay $750,000 In Suit on LSD Testing
nytimes.com 11.11.2007
SPECIAL TO THE NEW YORK TIMES
LEAD: The Justice Department announced today that it had settled a lawsuit by nine Canadians who charged that the C.I.A. made them the subjects of mind-control experiments involving drugs. (...)

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