Medical Product Safety Information (fda.gov/medwatch/safety)

Manglende sikkerhetsdokumentasjon According to researchers, the Center for Medical Devices and Radiological Health, the agency body responsible for tracking potential problems, often does not have access to the data it needs to evaluate products after they reach the market. (fiercehealthcare.com (24.1.2006))

Kirurger i USA fikk betalt for å bruke leddproteser (Tidsskr Nor Lægeforen 2008; 128: 74-6 (3.1.2008))

Ny fokus på granskning av bestikkelser: Leger (nytimes.com 22.3.2008)

Gruppe ber om forbud mot medisinske gaver (nytimes.com 28.4.2008)

Sjukhus dåliga på att rapportera farliga produkter (netdoktor.passagen.se 1.11.2006)

Senatet gransker medisinske utstyrsfirmaer (reuters.com 26.2.2008)

FDA-varslere (JAMA. 2009;301(2):152 (January 14))

Ny tvil om utstyr (Leder) (latimes.com 21.2.2006)

- Medisinsk utstyr godkjennes uten fullstendig gjennomgang

Author Insights: Many Devices Approved Without Comparative Effectiveness Data
JAMA 2012 (November 6)
Rita Redberg, MD, professor i medisin ved University of California, San Francisco og kolleger fant at mange høyrisiko kardiovaskulære enheter ble godkjent uten data på deres sammenlignende effektivitet. (Rita Redberg, MD, a professor of medicine at the University of California, San Francisco, and colleagues found that many high-risk cardiovascular devices were approved without data on their comparative effectiveness.)

About half of high-risk cardiac devices approved by the US Food and Drug Administration (FDA) were approved without comparative data on whether they provide better outcomes than other treatment options, found an analysis published online in JAMA. (...)

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

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

- Forskare varnar för brister inom medicinteknik. Flera studier som legat till grund för godkända förändringar av medicintekniska produkter i USA har varken varit randomiserade eller blindade, enligt nya fynd i tidskriften Jama.

(Anm: Forskare varnar för brister inom medicinteknik. Flera studier som legat till grund för godkända förändringar av medicintekniska produkter i USA har varken varit randomiserade eller blindade, enligt nya fynd i tidskriften Jama. Studierna berör avancerad teknik, exempelvis höftproteser och så kallade cochleaimplantat för hörselskadade. I USA regleras medicinteknisk utrustning av den amerikanska läkemedelsmyndigheten FDA. Det är vanligt att dessa produkter förändras efter en tid på marknaden, och nu ville amerikanska forskare undersöka kvaliteten på studier som legat till grund för godkända modifieringar. Deras analys innehåller 83 kliniska studier. Enligt resultaten var endast 45 procent av dessa randomiserade och 30 procent blindade. Forskarna fann också att majoriteten av studier inte hade primära effektmått som var kliniska utan i stället låg fokus på laborativa mätvärden. Även få studier hade kontrollgrupper. Det verkar som att FDA godkänt modifieringar utan tydligt kliniskt stöd gällande säkerhet och effekt, skriver forskarna bakom analysen. De nämner bland annat ett system för glukosmätning som godkänts av myndigheten trots att uppföljningstiden endast varade i sju dagar. (dagensmedicin.se 16.8.2017).)

(Anm: Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements. Question  What is the quality of clinical studies and data used to approve modifications to high-risk devices by the US Food and Drug Administration (FDA) panel-track supplement pathway? (…) Conclusions and Relevance Among clinical studies used to support FDA approval of high-risk medical device modifications, fewer than half were randomized, blinded, or controlled, and most primary outcomes were based on surrogate end points. These findings suggest that the quality of studies and data evaluated to support approval by the FDA of modifications of high-risk devices should be improved. JAMA. 2017;318(7):619-625.)

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

- Hendelser som involverer medisinsk utstyr. Statens helsetilsyn mottar jevnlig varsler om hendelser som involverer bruk av medisinsk utstyr. Det kan handle om feil på utstyr eller at utstyret brukes feil, og i noen tilfeller har det medført betydelig skade på pasient eller dødsfall.

(Anm: Hendelser som involverer medisinsk utstyr. Statens helsetilsyn mottar jevnlig varsler om hendelser som involverer bruk av medisinsk utstyr. Det kan handle om feil på utstyr eller at utstyret brukes feil, og i noen tilfeller har det medført betydelig skade på pasient eller dødsfall. (…) Foretakets ansvar Foretaket har ansvar for å sikre kvaliteten på medisinsk utstyr ved anskaffelser, og for opplæring i forsvarlig bruk av dette utstyret. Særlig aktuelt er ansvaret for opplæring når nytt medisinsk utstyr skal innføres. (helsetilsynet.no 5.5.2017).)

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

- Kongressen, FDA klar til å lette på tilsynet med medisinsk utstyr.

(Anm: Congress, FDA Poised to Loosen Oversight of Medical Devices. Industry to fund FDA—at a price. When makers of medical devices learn that one of their products has malfunctioned in a way that could kill or seriously injure people, they are required to file a report with the Food and Drug Administration (FDA). The reports are meant to alert regulators that patients may be in danger. However, in the future, under a deal the FDA has negotiated with industry lobbyists, manufacturers could generally wait three months before reporting malfunctions, and they could report malfunctions in “summary” form, according to an FDA document. (pogo.org 20.6.2017).)

(Anm: Overfortolkning af lovkrav koster dyrt for danske medicinalselskaber. Interview: De danske medicinalselskaber betaler i dyre domme for at leve op til gældende lovgivning. Overfortolkning koster dem dyrt, siger konsulent, der ellers selv tjener penge på at hjælpe virksomhederne. Stribevis af producenter af lægemidler og medicinsk udstyr er så bekymrede for ikke at leve op til lovgivning og regulering, at de ender med at bruge langt flere penge på at leve op til gældende lovgivning og regulering, end hvad der egentlig er nødvendigt... (finans.dk 2t.9.2017).)

(Anm: Flere indberetter svigt ved medicinsk udstyr. Lægemiddelstyrelsens årsrapport for medicinsk udstyr viser, at der kommer stadig flere indberetninger af fejl, svigt og mangler ved medicinsk udstyr. I 2015 blev der indberettet 2414 hændelser med medicinsk udstyr. Det er en stigning i forhold til 2014 og 2013, hvor der blev indberettet hhv. 2391 og 2001 hændelser. Tallene fremgår af Lægemiddelstyrelsens årsrapport for medicinsk udstyr 2015, og begrebet hændelser dækker både fejl, svigt og mangler. (laegemiddelstyrelsen.dk 1.7.2016).)

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

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

- Søgsmål om underlivsnet breder sig til Australien. Johnson & Johnsons transvaginale net fortsætter med at spøge i kulissen.

(Anm: Søgsmål om underlivsnet breder sig til Australien. Johnson & Johnsons transvaginale net fortsætter med at spøge i kulissen. Denne gang er det en gruppe af australske kvinder, der har indgivet et søgsmål mod den amerikanske gigant. Endnu et gruppesøgsmål om de såkaldte transvaginale net har ramt det amerikanske konglomerat Johnson & Johnson. Denne gang er det en gruppe på cirka 700 australske kvinder, der har indgivet søgsmålet. Det skriver Reuters.  De transvaginale net bruges til behandling af stressinkontinens og nedsunket bækkenorgan. Søgsmålet følger i hælene på en række lignende sager i USA, Canada og Europa.Anklagerne lyder blandt andet, at patienter, der har fået indopereret et transvaginalt net har fået kroniske smerter, blødninger og alvorligt ubehag ved samleje.Hos J&J lyder det, at man kun har været bekendt med 200 ”produktbegivenheder” ved mere end 100.000 solgte net i Australien. (medwatch.dk 6.7.2017).)

(Anm: Legemiddelverket overtar ansvaret for medisinsk utstyr. Helse- og omsorgsdepartementet har vedtatt at Helsedirektoratets forvaltningsoppgaver knyttet til området medisinsk utstyr skal overføres til Statens legemiddelverk med sikte på virkning fra 1. januar 2018. (legemiddelverket.no 24.5.2017).)

- MASSESØKSMÅL MOT LEGEMIDDELGIGANT: Tusenvis av kvinner mener denne har ødelagt livet deres. – Det ble fremstilt som en trygg og god «quick fix», forteller en norsk kvinne som fikk livet snudd på hodet etter inngrepet. Et implantat som brukes for å kurere stressinkontinens har gitt titusener av kvinner alvorlige bivirkninger.

(Anm: MASSESØKSMÅL MOT LEGEMIDDELGIGANT: Tusenvis av kvinner mener denne har ødelagt livet deres. – Det ble fremstilt som en trygg og god «quick fix», forteller en norsk kvinne som fikk livet snudd på hodet etter inngrepet. Et implantat som brukes for å kurere stressinkontinens har gitt titusener av kvinner alvorlige bivirkninger. Tusenvis av amerikanske kvinner har ifølge Daily Mail gått til søksmål mot produsenten av implantatene, Ethicon, som er et datterselskap av legemiddelfirmaet Johnson & Johnson. I september ble selskapet dømt til å betale 57 millioner dollar i erstatning til en amerikansk kvinne. Ifølge The Guardian har også over 700 australske kvinner gått til søksmål mot Johnson & Johnson, mens Sky News rapporterer at omlag 300 kvinner fra Storbritannia gjør det samme. (tv2.no 14.10.2017).)

(Anm: Medical device industry 'not doing enough on cybersecurity'. (…) Despite the threat, a survey by IT research organization the Ponemon Institute and chip security company Synopsys reveals that only 17% of device makers and 15% of HDOs are actively taking steps to tackle the problem, although a third were aware of the potential adverse effects to patients of an insecure medical device. (fiercepharma.com 26.5.2017).)

(Anm: Minister blames doctors for adverse reactions to mesh implants. A health minister has blamed doctors and their “arrogance towards women” for the large number of patients who have reported life changing adverse effects from mesh implant surgery. Jackie Doyle-Price, England’s social care minister, caused disappointment among campaigners on 18 October when she rejected calls for an immediate ban on the use of surgical mesh implants and for a public inquiry into the extent of adverse effects after their use for stress incontinence, vaginal prolapse, and hernia repair. She also caused confusion when she said that guidance from the National Institute for Health and Care Excellence would be issued “before the end of the year.” It transpired that she was referring to interventional procedures guidance on the use of the mesh and not clinical guidance, which is not due to be published until 2019. BMJ 2017;359:j4889 (Published 20 October 2017).)

- Norske sykehus forfaller: Må bruke telefaks og verdens eldste kreftmaskin. (- Men sannheten er at det norske helsevesenet ikke er bærekraftig fordi investering i ny teknologi og utstyr er nedprioritert.)

Norske sykehus forfaller: Må bruke telefaks og verdens eldste kreftmaskin
tv2.no 11.3.2017
Helsepersonell løper fortere enn før, men norske sykehus har ikke blitt mer effektive av den grunn. Det skyldes for få investeringer i nytt utstyr og teknologi.

Det er flere leger, flere sykepleiere, høyere levealder og færre unngåelige dødsfall enn tidligere.

Men sannheten er at det norske helsevesenet ikke er bærekraftig fordi investering i ny teknologi og utstyr er nedprioritert.

Utdatert
Det slår en ny rapport om helseutgifter fast. Rapporten «Bruker vi for mye på helse?» utført av Menon Economics på oppdrag fra Legeforeningen og Norsk Sykepleierforbund ble offentliggjort fredag.

Det står mindre utstyr, maskiner og bygg bak hver ansatt i helsesektoren i dag enn for 10 år siden. Og over tretti prosent av all medisinsk utstyr i Norge er utdatert.

– Vi ser at drift i økende grad har blitt prioritert fremfor investeringer. Det hjelper ikke å løpe fort om man ikke har godt verktøy. Det sier seg selv at en håndverker som kun får benytte seg av en håndsag kan få til mye, men med elektrisk verktøy ville han kommet enda lengre, sier Erland Skogli, partner i Menon Economics og en av forfatterne bak rapporten.

Ved å ikke gjøre større investeringer i teknologi skisserer rapporten to alvorlige utfall:

  • Dødsraten i Norge vil øke i forhold til i andre land.
  • Helsevesenet deles i to, hvor de rike kjøper seg den beste behandlingen. (…)

(Anm: Defibrillators made by St Jude Medical are prone to battery failure, FDA warns. BMJ 2016;355:i5571 (Published 14 October 2016).)

(Anm: Medisinsk utstyr kan hackes. Amerikanske myndigheters granskning fastslår nå at pacemakere og implanterte hjertestartere "på nett" har farlige sikkerhetshull.Dagens pacemakere og implanterte hjertestartere har trådløs kommunikasjon og kan kobles på internett, skriver artikkelforfatterne. I tv-serien Homeland ble den amerikanske visepresidenten (til høyre) tatt livet av ved at pacemakeren hans ble hacket. (dn.no 19.1.2017).)

(Anm: Hendelser som involverer medisinsk utstyr. Statens helsetilsyn mottar jevnlig varsler om hendelser som involverer bruk av medisinsk utstyr. Det kan handle om feil på utstyr eller at utstyret brukes feil, og i noen tilfeller har det medført betydelig skade på pasient eller dødsfall. (…) Foretakets ansvar Foretaket har ansvar for å sikre kvaliteten på medisinsk utstyr ved anskaffelser, og for opplæring i forsvarlig bruk av dette utstyret. Særlig aktuelt er ansvaret for opplæring når nytt medisinsk utstyr skal innføres. (helsetilsynet.no 5.5.2017).)

(Anm: U.S. FDA clears Xarelto blood thinner despite faulty trial device. Oct 11 (Reuters) - The U.S. Food and Drug Administration on Tuesday said it has determined the widely-used blood thinner Xarelto to be safe and effective for patients with the heart condition atrial fibrillation after serious doubts arose over the major study used to gain approval of the drug. (finance.yahoo.com 11.10.2016).)

(Anm: The Sarepta dilemma: Bioethics expert Arthur Caplan says it’s time to rethink how to regulate compassion. Arthur Caplan was never enthusiastic about the idea of an FDA approval for Exondys 51 (eteplirsen) for Duchenne muscular dystrophy. When it came through, the noted NYU bioethics expert saw it as a deviation from the FDA’s policies on how drugs should be studied and reviewed, focusing on safety and a clear signal of efficacy. But there were a lot of things wrong with it. “The trial was poor,” Caplan tells me, “and even with small numbers I think it could have been done better.” The vehement public lobbying by Duchenne families to get it across the finish line also didn’t convince him that the agency needed to make it available. (endpts.com 10.10.2016).)

(Anm: Ambu-direktør: Smittefare på hospitaler får alt for lidt opmærksomhed. Det har været et begivenhedsrigt første halvår af 2016 for medicoselskabet Ambu, men adm. direktør Lars Marcher stiller sig også kritisk over for dialogen om smittefaren på hospitaler og de nye regler for medicinsk udstyr. (medwatch.dk 29.7.2016).)

(Anm: Endelig rapport: Alvorlige blødninger hos to barn etter mandeloperasjon– fikk ikke forsvarlig helsehjelp. Bakgrunnen for dette tilsynet var en uventet alvorlig hendelse der en fem år gammel pike fikk akutt og alvorlig blødning ni dager etter mandeloperasjon på en privatklinikk. Etter at det stedlige tilsynet fant sted, ble det varslet om en ny hendelse der også en gutt på fire år fikk alvorlige blødninger fire dager etter mandeloperasjon ved samme klinikk. Gutten døde som følge av den alvorlige komplikasjonen. Ved utførelsen av mandeloperasjonene ble det benyttet diatermi (høyfrekvent vekselstrøm ved lav spenning for å varme opp vevet), såkalt «varm kirurgi».  Diatermiapparatet var rutinemessig innstilt på maksimal effekt. Den aktuelle operatøren var daglig leder og kirurg ved klinikken. Han representerte derfor virksomheten, i tillegg til at han utførte samtlige mandeloperasjoner ved klinikken.  (helsetilsynet.no 9.3.2017).)

- Produktfeil gjorde at sykehusutstyr ikke ble vasket

Produktfeil gjorde at sykehusutstyr ikke ble vasket
aftenposten.no 20.7.2012
Olympus er ansvarlige for produksjonsfeilen på vaskemaskinen ved et sykehus i Danmark. Norske sykehus har samme leverandør.

En feil ved en vaskemaskin på Slagelse Sygehus i Danmark kan ha ført til at over 700 pasienter er blitt smittet med HIV-virus eller leverbetennelse. Det bekrefter sykehuset overfor Aftenposten.no.

- Alle pasienter er blitt undersøkt bakterielt, og ingen har hatt infeksjon. Men vi har ennå ikke fått kontrollert for om de har virusinfeksjon, sier ledende oversykepleier ved kirurgisk avdeling ved Slagelse sykeshus Dorthe Denta. (...)

(Anm: Hygiene (smittsomme sykdommer / infeksjoner / smittevern) (mintankesmie.no).)

- FDA tjenestemenn ønsker et nasjonalt kontrollsystem for medisinsk utstyr

FDA officials want a national review system for medical devices
massdevice.com 12.7.2016
A pair of top officials at the FDA are advocating for a national oversight system for medical devices that would combine pre- and post-market clinical studies with adverse event reporting and electronic health records.

FDA commissioner Dr. Robert Califf and Dr. Jeffrey Shuren, head of the agency’s Center for Devices & Radiological Health, wrote in the Journal of the American Medical Assn. that their vision would incorporate “ecosystem stakeholders such as patients, health care professionals, health care organizations, payers, the medical device and digital health industries, and the government.”

Their system would be built on the National Evaluation System for Health Technology the FDA launched in 2012, taking “a strategic approach to linking and using clinically based data sources, such as registries, electronic health records (EHRs), and claims data” that “could potentially reduce the burdens of obtaining appropriate evidence across the life cycle of a device.” (…)

(Anm: Medical executives face criminal charges for “misbranded” devices. Two US medical device executives are facing criminal charges for off-label promotion of a device to treat nasal sinus problems. (…) This was not the first time that a device cleared through the 510(k) pathway made it on to the market despite being manufactured in a manner intended to enable off-label use rather than the original use in the predicate device cited. BMJ 2016;353:i3270  (Published 10 June 2016).)

(Anm: Sinus Attack! Pain in the forehead or between the eyes? Upper teeth ache? Face feeling full, nose stuffy and congested? You may have a common complaint that sends many people to a doctor's office: sinus trouble. (webmd.com 5.5.2017).)

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

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

(Anm: Frykter at medisinsk utstyr skal hackes – nå bes bransjen om å rydde opp. Digitalisering av helsesektoren fører med seg innovasjon, men også økt risiko. Amerikanske myndigheter kommer nå med klare formaninger til bransjen om å sikre produktene mot kybertrusler. (digi.no 29.12.2016).)

(Anm: Editorials. Pacemaker battery scandal.  Much can and should be done to maximise the longevity of existing devices. BMJ 2016;352:i228 (Published 04 February 2016).)

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

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

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

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

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

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

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

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

(Anm: Industry paid $6.5 bn to US physicians and hospitals in 2014. BMJ 2015;351:h3697 (Published 07 July 2015).)

- Den danske virksomhed BK Medical har sammen med dets amerikanske moderselskab betalt omkring 100 millioner kroner i to forlig med de amerikanske myndigheder for en måned siden.

Dansk firma betaler gigantbøde for at undgå sag om bestikkelse.
dr.dk 18.7.2016
Den danske virksomhed BK Medical har betalt en rekordhøj bøde til de amerikanske myndigheder i juni for at undgå en retssag om mulig korruption.

Den danske virksomhed BK Medical har sammen med dets amerikanske moderselskab betalt omkring 100 millioner kroner i to forlig med de amerikanske myndigheder for en måned siden.

Det sker for at undgå retssager om mulig bestikkelse, bedrageri, skatteunddragelse og overtrædelse af den amerikanske regnskabslovgivning. BK Medical fremstiller ultralydsudstyr og har hovedsæde i Herlev ved København.

Det fremgår af pressemeddelelser fra det amerikanske finanstilsyn og justitsministerium. (...)

(Anm: Dansk medicoselskab betaler trecifret millionbeløb i amerikansk forlig. En langvarig bestikkelsessag er nu endt med et trecifret millionforlig for den danske udvikler af ultralydsudstyr BK Medical. (medwatch.dk 18.7.2016).)

(Anm:Disclosing payments from drug companies should be mandatory for doctors, says academy. BMJ 2015;351:h4197  (Published 03 August 2015).) 

(Anm:The uneasy, unbreakable link of money, medicine. (medicalnewstoday.com 3.8.2015).)

(Anm: – Å tolke bildene er som å lese i kaffegrut. Ulike krav til stat og privat. Mens private helseaktører må vrake syv år gammelt røntgenutstyr, opererer Oslo universitets­sykehus med maskiner fra forrige århundre. Foretakstillitsvalgt Eli Skorpen, her med 17 år gammelt mr-utstyr, ønsker at Helse Sør-Øst skal stille samme krav til eget sykehus, Oslo universitetssykehus, som til private. (dn.no 2.12.2015).)

(Anm: How Much Medical Sales People Can Make. (…) Let’s get right to it, how much money do medical sales reps earn on average? According to the newest MedRep survey the average medical sales rep salary in 2016 is $145,147, with an average base of $88,038, an increase in both numbers since 2015. Of those who responded, the majority of work for manufacturers while a third of respondents sell medical or surgical devices, and one quarter sell pharma or specialty pharma. (cafepharma.com 16.6.2016).)

(Anm: CardioBrief: Dollars for Heart Docs. —Analysis of CMS database shows some docs pocketed millions from drug and device makers. $300 million dollars. That's how much industry paid to cardiologists and other related healthcare professionals between August 2013 and December 2014 for consulting, speaking, and other various activities, according to new data published by CMS in the Open Payments database. (medpagetoday.com 23.7.2015).)

- Biomet havde betalt bestikkelse til statsansatte leverandører af sundhedsydelser i Argentina, Brasilien og Kina for at sikre sig forretninger med hospitaler. (- Ifølge anklagerne havde Biomet gemt betalinger i dets regnskaber som "kommission", "konsulenthonorarer", "royalties" og "videnskabelige incitamenter".)

Biomet bryder aftale med det amerikanske justitsministerium.
medwatch.dk 16.6.2016
Det amerikanske medicoselskab Zimmer Biomet har haft svært ved at overholde en aftale med det amerikanske justitsministerium, som blev indgået tilbage i 2012 i forbindelse med en korruptionssag.

En aftale mellem det amerikanske medicoselskab Biomet (i dag Zimmer Biomet) og det amerikanske justitsministerium indgået tilbage i 2012 er nu blevet misligholdt af Biomet. Det skriver Reuters.

Aftalen blev indgået for at forlige anklager om, at Biomet havde betalt bestikkelse til statsansatte leverandører af sundhedsydelser i Argentina, Brasilien og Kina for at sikre sig forretninger med hospitaler. Ifølge anklagerne havde Biomet gemt betalinger i dets regnskaber som "kommission", "konsulenthonorarer", "royalties" og "videnskabelige incitamenter". (…)

(Anm: How a medical device maker kept U.S. hospitals in the dark about deadly infections. (…) Even as patients died and others were put at risk, Olympus continued to sell the device and failed to warn U.S. hospitals that the scopes were tied to dangerous infections, according to interviews with dozens of hospital officials, doctors, regulators and former Olympus employees. (latimes.com 19.12.2015).)

(Anm: Manufacturers failed to report infections from duodenoscopes, US investigation finds. Manufacturers of hard to clean duodenoscopes that spread potentially life threatening, antibiotic resistant bacterial infections to hundreds of patients in the United States and Europe failed to meet their legal obligations to report serious infections and deaths to federal regulators, says a US Senate committee report released on 13 January. BMJ 2016;352:i240 (Published 14 January 2016).)

(Anm: U.S. FDA knew devices spread fatal 'superbug' but does not order fix. U.S. health regulators have known since at least 2009 that the medical devices at the center of the "superbug" outbreak at UCLA can transmit lethal infections but have not recommended any new safety requirements, a lapse that threatens patient safety, experts in hospital-acquired infections said. The latest outbreak involving the reusable devices called duodenoscopes, which are inserted down the throat, may have exposed 179 patients at UCLA's Ronald Reagan Medical Center in Los Angeles and contributed to two deaths. (reuters.com 20.2.2015).)

(Anm: FDA-nøl i amerikansk medico-skandale. Det tog 17 måneder før de amerikanske sundhedsmyndigheder fik advaret læger og offentligheden om livstruende bakterier. Det der bør fungere som patienter og forbrugeres vagthund på sundhedsområdet, den amerikanske sundhedsmyndighed, FDA, har fejlet. Det skriver The Wall Street Journal. (medwatch.dk 19.1.2016).)

(Anm: FDA Took 17 Months to Notify Doctors on Scopes’ ‘Superbug’ Dangers. Senate Democrats’ report says 16 U.S. hospitals traced drug-resistant infections to devices. Food and Drug Administration took 17 months to notify doctors and the public of “superbug” infection dangers from certain scopes used in gastrointestinal procedures in hospitals, according to a report by Senate Democrats released Wednesday. (washingtonpost.com 14.1.2016).)

(Anm: Konkurrencemyndighed undersøger det franske høreapparatmarked. De franske konkurrencemyndigheder har igangsat en undersøgelse af høreapparatmarkedet i Frankrig, hvor især danske William Demant sidder tungt på detailbranchen. (medwatch.dk 10.2.2016).)

- Organisationer: Medicinsk udstyr skal kontrolleres grundigere (- Det er uholdbart, at det er forbrugerne, der skal være forsøgspersoner.)

Organisationer: Medicinsk udstyr skal kontrolleres grundigere
b.dk 21.5.2015
Efter de seneste års skandalesager med medicinsk udstyr som blandt andet kunstige hofter og hjerteklapper kræver læge- og patientorganisationer, at reglerne omkring udstyret strammes.

Det er alt sammen medicinsk udstyr, der opereres ind i kroppen på patienter, og som de seneste år har været centrum for flere skandalesager.

Det bør derfor overvåges, testes og evalueres langt grundigere, end det bliver i dag, mener både Lægeforeningen og Forbrugerrådet TÆNK, skriver Jyllands-Posten.

»Det er absurd, at medicinsk udstyr, som skal opereres ind i kroppen, ikke følger samme lovgivning som lægemidler, der skal testes grundigt i kliniske studier, før de frigives til forbrugerne. Det bliver mere og mere normalt at få indopereret medicinske reservedele i kroppen, så det er uholdbart, at det er forbrugerne, der skal være forsøgspersoner,« siger seniorrådgiver Sine Jensen, Forbrugerrådet Tænk, til Jyllands-Posten.

Både Forbrugerrådet Tænk og Danske Patienter er enige i, at manglende afprøvninger og test går hårdt ud over patientsikkerheden.

Lægeforeningen kræver blandt andet at udstyret overvåges gennem et nationalt implantatregister, hvor patienter kan blive registreret, så det vil være nemmere at finde patienterne, hvis der er fejl ved udstyret.

Sundhedsminister Nick Hækkerup (S) har meldt ud, at sådan et register vil blive oprettet. (…)

(Anm: Er udstyret i orden? - Debat om medicinsk udstyr (taenk.dk 4.7.2013).)

(Anm: Medicoindustrien kalder kritik "forenklet". Myndighederne herhjemme og i EU er i fuld gang at finde løsninger på mange af de problemstillinger, som Lægeforeningen og Forbrugerrådet Tænk rejser om medicinsk udstyr, mener Medicoindustrien. (medwatch.dk 21.5.2015).)

(Anm: Deadly superbug infections from tainted scopes greater than thought. The number of potentially deadly infections from contaminated medical scopes is far higher than what federal officials previously estimated, a new congressional investigation shows. As many as 350 patients at 41 medical facilities in the U.S. and worldwide were infected or exposed to tainted gastrointestinal scopes from Jan. 1, 2010, to Oct. 31, 2015, according to the Food and Drug Administration. (cnn.com 15.4.2016).)

(Anm: Ble feilinformert om positiv klamydiatest. Tusen pasienter kan ha fått feil svar på kjønnssykdomsstest. (…) I Roche Diagnostics Norge AS sier de imidlertid at de ikke har gjort noe galt. – Vi mener vi har gitt god nok opplæring. Det er sterkt beklagelig at dette skjer, men så lenge det er mennesker involvert i testingen så kan slikt dessverre skje, sier administrerende direktør Jens Jensen. (nrk.no 7.6.2016).)

(Anm: Dansk medicovirksomhed taber international scannerstrid. Den danske medicovirksomhed LBN Medical har i Sø- og Handelsretten tabt en millionstrid om en mangelfuld MR-scanner leveret til en spansk diagnostikvirksomhed. (medwatch.dk 24.6.2015).)

(Anm: Tandsjukdom efter implantat. Nästan var sjätte person som fått tandimplantat drabbas av en allvarlig inflammation i angränsande vävnader, peri-implantit. Det visar en studie vid Sahlgrenska akademin i Göteborg. Studien omfattar 4 716 personer som fick tandimplantat 2003-2004. Nio år efteråt hade 14,5 procent drabbats av peri-implantit, som liknar tandlossning men har ett snabbare och aggressivare förlopp, skriver Dagens Nyheter. De som drabbas behöver ytterligare behandling, vilket kan bli ekonomiskt kännbart. Över 30 000 patienter i Sverige fick förra året nya tänder som skruvas fast i käkbenet. (dagensmedisin.no 28.10.2015).)

(Anm: Antidepressiva er ifølge ny studie knyttet til mislykkede tannimplantater. (Antidepressants linked to tooth implant failure, new study finds.) (- Forskning viser at bruk av antidepressiva firedobler risikoen for implantat svikt. For hvert år dobler antidepressiva risikoen for svikt.) (medicalnewstoday.com 10.3.2016).)

(Anm: Antidepressiva ökar risken för benbrott hos äldre. (…) Den förhöjda risken för höftfraktur gällde alla de vanliga antidepressiva läkemedlen, SSRI-preparat, mirtazapin och SNRI-preparat (selektiva serotonin- och noradrenalinåterupptagshämmare. Sambandet gällde även då det kontrollerats för andra faktorer som ålder, annan medicinering som ökar fallrisken, benskörhet, socioekonomisk status, kroniska sjukdomar och psykiatriska diagnoser.) (lakemedelsvarlden.se 12.1.2017).)

(Anm: Heart disease risk higher with latent tooth infection. If you missed your last dental checkup, a new study might encourage you to book that appointment right away; researchers have identified a higher risk of heart disease for individuals who have hidden tooth infections. (…) Last year, for example, a study published in Infection and Immunity suggested that the bacterium involved in gum disease may also raise the risk of heart disease. Now, researchers from the University of Helsinki in Finland have uncovered a link between dental root tip infection, known as apical periodontitis, and greater risk for acute coronary syndrome (ACS) - an umbrella term for conditions that involve blocked blood flow to the coronary arteries. (medicalnewstoday.com 3.8.2016).)

(Anm: Munhälsan bättre än på 80-talet – men tandlossning ökar igjen. De två största tandsjukdomarna karies och parodontit (tandlossning) minskade fram till 2008. Därefter ökade antalet individer med parodontit och den positiva utvecklingen för karies stannade av. – Även om munhälsan har förbättras under denna 30-årsperiod ser vi en försämring mellan 2008 och 2013 då det gäller främst tandlossning, säger Kristina Edman vid Uppsala universitet har undersökt munhälsans utveckling över en trettioårsperiod. (forskning.se 3.5.2016).)

(Anm: Stimulant Medications Linked to Bone Mass Reductions in Children, Adolescents. BOSTON -- April 6, 2016 -- Use of stimulant medications in the treatment of attention deficit hyperactivity disorder (ADHD) in childhood and adolescence is associated with significant reductions in bone mass, according to a study presented here at the 98th Annual Meeting of the Endocrine Society (ENDO). (…) “We suggest that stimulant medications, which release and block reuptake of dopamine and norepinephrine, may affect bone mass,” said the researchers. (dgnews.docguide.com 6.4.2016).)

(Anm: FDA warns of unintentional head movement during surgery despite use of skull clamp. The FDA warned healthcare providers of the risk of skull clamp slippage before or during surgical procedures, saying it has received more than 1,000 reports of the problem since 2009. (fiercepharma.com 26.2.2016).)

(Anm: US to require safety warnings for Essure sterilization device. BMJ 2016;352:i1283 (Published 03 March 2016).)

(Anm: Olympus to pay $646m to settle charges over device sales. BMJ 2016;352:i1309 (Published 03 March 2016).)

(Anm: New England Journal of Medicine essay on morcellation prompts a call for retraction. An essay by a New England Journal of Medicine correspondent that questioned the US Food and Drug Administration’s (FDA) ruling that power morcellation was contraindicated in most women for the removal of benign uterine fibroids has prompted a call for a retraction and an apology by two doctors leading the fight against the device’s use. BMJ 2016;352:i1752 (Published 24 March 2016).)

- Dårlig test af sikkerhed

Nye studier ser store problemer med amerikanske medicogodkendelser
medwatch.dk 13.8.2015
MedWatch anbefaler:   Et nyt studie peger på, at godkendelsestiden for nye, innovative medicoprodukter i USA er uforholdsmæssig lang, mens et andet studie påpeger, at sikkerheden af de produkter, der bliver skubbet hurtigt ud på markedet, ikke undersøges ordentligt.

Mens de amerikanske myndigheder, FDA, der står for godkendelser af nye medicinal- og medicoprodukter i landet, har gjort store fremskridt for at nedbringe tiden for evaluering af ansøgninger for lægemidler, så har man ikke sikret den samme fremgang inden for evaluering af medicinsk udstyr, konkluderer et nyt studie.

Samtidig peger et andet studie på, at sikkerheden af de produkter, der kommer hurtigere på markedet gennem en særlig regulatorisk genvej, ikke bliver ordentligt undersøgt.

FDA’s evalueringsproces ser ud til at forsinke godkendelse af nye, innovative medicoprodukter, hvilket pålægger producenterne yderligere omkostninger. Det er ifølge erhvervsmagasinet Forbes konklusionen i studiet “Innovation under Regulatory Uncertainty: Evidence from Medical Technology,” som er foretaget af Ariel Dora Stern fra Harvard Business School. (…)

”Jeg blev ved med at høre, hvor frustrerende og uigennemskuelig processen for godkendelse af nyskabende medicinsk udstyr er,” siger Ariel Dora Stern til Forbes.

Dårlig test af sikkerhed
FDA har dog indført en genvej til markedet for medicoprodukter kaldet Premarket Approval. Gennem denne genvej kan højrisiko-medicoprodukter blive godkendt til markedet efter blot et studie, der viser produktets effekt og sikkerhed. Producenten skal så efterfølgende foretage yderligere studier for at verificere sikkerheden.

Men et andet studie viser, at der er langt mellem disse postmarketing-studier i USA. Det skriver Reuters.

Studiet, som er foretaget af Dr. Joseph S. Ross fra Yale University School of Medicine, har undersøgt alle de 28 højrisiko-produkter, der opnåede tidlig godkendelse fra FDA i 2010 og 2011.

Her er konklusionen ifølge nyhedsbureauet, at selvom man i USA har et strengere system for godkendelse af medicinsk udstyr, så har man ikke de samme muligheder for at følge op på sikkerheden af udstyret, efter det er kommet på markedet, som man for eksempel har i Europa. (…)

- Alle resultater fra kliniske studier på legemidler, vaksiner og medisinskteknisk utstyr må publiseres, fastslår organisasjonen, i sitt nyeste forsøk i kampen mot tilbakeholdelse av forskningsdata.

Krever åpenhet om alle resultater.
dagensmedisin.no 15.4.2015
– Vår intensjon med dette er å dele kunnskapen om forskningen for å bedre folkehelsen, uttaler Dr. Marie-Paule Kieny i WHO, som onsdag kom med sin uttalelse:

Alle resultater fra kliniske studier på legemidler, vaksiner og medisinskteknisk utstyr må publiseres, fastslår organisasjonen, i sitt nyeste forsøk i kampen mot tilbakeholdelse av forskningsdata.

Legemiddelindustrien har kommet et stykke på vei for å forplikte seg til offentliggjøring, men kritikerne mener de ikke gjør nok for å sikre at leger har tilgang til alle data fra kliniske studier.

WHO vil også at eldre studier som ikke er offentliggjort skal offentliggjøres. Resultater fra disse kan fortsatt være viktige i forskning og medisinsk praksis i dag. (…)

(Anm: WHO calls for increased transparency in medical research (who.int 14.4.2015).)

(Anm: FN krever global handling for åpenhet om kliniske forsøk. (UN calls for global action on clinical trial transparency. In a landmark report released today, the United Nations called on governments worldwide to pass legislation requiring clinical trials to be registered, and their methods and results to be fully reported. The report, authored by a high-level panel appointed by UN Secretary General Ban Ki-moon, explicitly calls for clinical trial study designs, protocols, data sets, and test results to be made publicly available.) (alltrials.net 14.9.2016).)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(Anm: Association of anticholinergic burden with adverse effects in older people with intellectual disabilities: an observational cross-sectional study. Conclusions Older people with intellectual disabilities and with mental health conditions were exposed to high anticholinergic burden. This was associated with daytime dozing and constipation. The British Journal of Psychiatry Dec 2016, 209 (6) 504-510.)

(Anm: New study links autism to mutations in mitochondrial DNA (medicalnewstoday.com 31.10.2016).)

(Anm: Økning i dødsfall blant pasienter med psykiske lidelser må etterforskes, sier parlamentsmedlem. (Rise in deaths of mental health patients needs investigating, says MP.) BMJ 2016;352:i518 (Published 26 January 2016).)

(Anm: Medisinske feil — den tredje største dødsårsaken i USA. Medisinske feil inkluderes ikke i dødsattester eller i rangeringen av dødsårsaker. (...) Medisinske feil "fører til mer enn 250 000 dødsfall i USA årlig". (Medical error—the third leading cause of death in the US. Medical error is not included on death certificates or in rankings of cause of death. (...) Medical error 'causes more than 250,000 deaths in the U.S. annually.) BMJ 2016;353:i2139 (Published 03 May 2016).)

(Anm: Forskere: Medisinske feil nå tredje største dødsårsak i USA (Researchers: Medical errors now third leading cause of death in United States) (washingtonpost.com 3.7.2016).)

(Anm: Legemiddelfirmaer har inngått forlik om påstander om villeding av leger om overlevelsesdata for kreft. (Drug companies settle claim of misleading doctors on cancer survival data) (- Medisinsk svindel sto for mer enn halvparten av 3,5 milliarder dollar som ble utbetalt i erstatninger i fjor. Vanligvis involverte dette beskyldninger om bestikkelser betalt for å generere falske pasienter eller unødvendige behandlinger og resepter som er belastet Medicare.) BMJ 2016;353:i3361 (Published 15 June 2016).)

(Anm: Den britiske regjeringen har drevet lobbyvirksomhet overfor EU-kommisjonen for å få vedtatt en mer avslappet tilnærming til reguleringer av legemidler, medisinsk utstyr og mat, ifølge et brev som BMJ har fått tilgang til. (The UK government has been lobbying the European Commission to adopt a more relaxed approach to regulating drugs, devices, and food, a letter seen by The BMJ has shown.) BMJ 2016;353:i3357 (Published 15 June 2016).)

(Anm: Gruppe (Transparency International) ber om flere tiltak for å takle korrupsjonen innen legemiddelindustrien. (Group calls for more to be done to tackle corruption in the pharmaceutical industry) (…) På begynnelsen av 2016 har én av 10 korrupsjonsundersøkelser i USA involvert legemiddelfirmaer, hvilket ifølge rapporten er et langt høyere antall saker enn det som involverer banksektoren. BMJ 2016;353:i3099 (Published 02 June 2016).)

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

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

(Anm: Udenlandske hospitaler vil bruge dansk sporing. Det skal være lettere at spore og tælle medicinsk udstyr på hospitalerne. Derfor har en ung dansk virksomhed udviklet et sporings- og tællesystem, der allerede mærker stor efterspørgsel fra udlandet. Selskabet har netop åbnet et ”USA-kontor”. (medwatch.dk 18.3.2015).)

- EUs godkjenningssystem setter døren åpen for farlig utstyr

Medical Device Regulation (Regulering av medisinsk utstyr)
EU approval system leaves door open for dangerous devices (EUs godkjenningssystem setter døren åpen for farlig utstyr)
BMJ 2012;345:e7173 (24 October 2012)
Da BMJ og Daily Telegraph besøkte myndighetenes kontrollorgan EVPU i nordlige Slovakia var kontorene fylt med utbrente vannkokere og brødristere, som vitnet om de "sikkerhets"-tester som finner sted i bygningen. EVPU er et av de private firmaene som vurderer om elektriske produkter er trygge nok til å selges i hele EU. De avgjør om et produkt kan gis et CE-sertifikat som tillater at det kan selges over hele Europa. (When the BMJ and Daily Telegraph visited the notified body EVPU in northern Slovakia, its offices were lined with burnt-out kettles and toasters, testimony to the “safety” tests that take place in the building. EVPU is one of the private companies that assesses whether electrical products are safe to be sold throughout the European Union. It decides whether to award a product a CE certificate to allow it to be sold across Europe.)

Men selskapets aktiviteter er ikke begrenset til lisensiering av vannkokere og brødristere for å se om de går i luften når de pugges inn etter europeiske regler, firmaet er også autorisert for å sertifisere medisinske implantater som hofte- og kneproteser. (But, the company’s activities are not restricted to licensing kettles and toasters to see if they blow up when plugged in—under European rules, the firm is also authorised to certify medical implants such as hips and knee prostheses.)

Det europeiske systemet for regulering har skapt utbredt bekymring om hvorvidt medisinske eksperter virkelig er i første linje når det gjelder å avgjøre hvilke enheter som kan implanteres i pasienter. (...) (The European system of regulation has sparked widespread concern over whether medical experts are really at the vanguard of deciding which devices can be implanted in patients.)

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

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

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

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

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

(Anm: US FDA to accept foreign trial data for approving medical devices. The FDA is releasing draft guidance articulating its current policy of accepting valid clinical data obtained from foreign clinical studies in support of premarket submissions for medical devices. .. (outsourcing-pharma.com 21.4.2015).)

- FDAs divisjonsledere ignorerer sikkerhetsspørsmål ved godkjenning av utstyr

Dispute Flares Inside FDA Over Safety of Popular Blood-Pressure Drugs (Krangel om sikkerheten til populære blodtrykksmedisiner blusser opp innen FDA)
online.wsj.com 30.5.2013
Den mest solgte klassen av blodtrykksmedisiner er under angrep fra en ualminnelig kilde: en seniorkontrollør hos Food and Drug Administration. (The top-selling class of blood-pressure drugs is under attack from an unusual source: a senior regulator at the Food and Drug Administration.)

Thomas A. Marciniak trosser sjefene og ber om sterkere advarsler om legemidler kjent som angiotensin reseptor blokkere eller ARB-er, ifølge interne dokumenter som er gjennomgått av The Wall Street Journal. (...) (Bucking his bosses, Thomas A. Marciniak is seeking stronger warnings about the drugs known as angiotensin receptor blockers, or ARBs, according to internal documents reviewed by The Wall Street Journal.)

ARB-er på markedet i USA inkluderer Novartis AG's Diovan, Daiichi Sankyo Co.'s Benicar, Merck & Co.'s Cozaar, Boehringer Ingelheim GmbH's Micardis; Avapro, fra Sanofi SA og Bristol-Myers Squibb Co.; og AstraZeneca PLC's Atacand. Pasienter som tar disse legemidler for å unngå hjerteanfall, slag og hjertesvikt. (...) (ARBs on the market in the U.S. include Novartis AG's Diovan, Daiichi Sankyo Co.'s Benicar, Merck & Co.'s Cozaar, Boehringer Ingelheim GmbH's Micardis; Avapro, from Sanofi SA and Bristol-Myers Squibb Co.; and AstraZeneca PLC's Atacand. Patients take these medicines daily to avoid heart attack, stroke and heart failure.)

Det er det som skjedde innen FDA sier Dr. Marciniak, som advarte andre i kontrollorganet mot at resultater i tabellform fra firmaer høyst sannsynlig produserte upålitelige resultater: "Søppel inn, søppel ut," skrev han. (That is what happened to the FDA, says Dr. Marciniak, who warned others in the agency that taking results tabulated by companies was likely to produce unreliable results: "Garbage in, garbage out," he wrote.)

Blant annet sa Dr. Marciniak i en intern analysegjennomgang av journalen at FDAs metaanalyser ikke teller opp tilfeller av "lungekreftsvulster" som lungekreft, hvilket de er. (Among other things, Dr. Marciniak said in an internal analysis viewed by the Journal that the FDA meta-analysis didn't count cases of "lung carcinomas" as lung cancers, which they are.)

Mens slike dissenser mellom FDA-vurderere sjeldent kommer til uttrykk har indre stridigheter om legemidler eller medisinsk utstyr noen ganger oppstått. I 2008 skrev ni ansatte i FDAs ustyrsdivisjon til medlemmer i kongressen og fortalte at divisjonsledere ignorerer sikkerhetsspørsmål ved godkjenning av utstyr. (...) (While such vocal dissent by FDA reviewers is rare, internal disputes about drugs or medical devices have occasionally arisen. In 2008, nine employees in the FDA's device division wrote to members of Congress saying the division's leaders were ignoring safety issues when approving devices.)

(Anm: Angiotensin II receptor antagonist (en.wikipedia.org).)

(Anm: Varslere (medisinske varslere) (whistleblowers) etc. (mintankesmie.no).)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(Anm: Association of anticholinergic burden with adverse effects in older people with intellectual disabilities: an observational cross-sectional study. Conclusions Older people with intellectual disabilities and with mental health conditions were exposed to high anticholinergic burden. This was associated with daytime dozing and constipation. The British Journal of Psychiatry Dec 2016, 209 (6) 504-510.)

(Anm: New study links autism to mutations in mitochondrial DNA (medicalnewstoday.com 31.10.2016).)

(Anm: Økning i dødsfall blant pasienter med psykiske lidelser må etterforskes, sier parlamentsmedlem. (Rise in deaths of mental health patients needs investigating, says MP.) BMJ 2016;352:i518 (Published 26 January 2016).)

(Anm: Medisinske feil — den tredje største dødsårsaken i USA. Medisinske feil inkluderes ikke i dødsattester eller i rangeringen av dødsårsaker. (...) Medisinske feil "fører til mer enn 250 000 dødsfall i USA årlig". (Medical error—the third leading cause of death in the US. Medical error is not included on death certificates or in rankings of cause of death. (...) Medical error 'causes more than 250,000 deaths in the U.S. annually.) BMJ 2016;353:i2139 (Published 03 May 2016).)

(Anm: Forskere: Medisinske feil nå tredje største dødsårsak i USA (Researchers: Medical errors now third leading cause of death in United States) (washingtonpost.com 3.7.2016).)

(Anm: Legemiddelfirmaer har inngått forlik om påstander om villeding av leger om overlevelsesdata for kreft. (Drug companies settle claim of misleading doctors on cancer survival data) (- Medisinsk svindel sto for mer enn halvparten av 3,5 milliarder dollar som ble utbetalt i erstatninger i fjor. Vanligvis involverte dette beskyldninger om bestikkelser betalt for å generere falske pasienter eller unødvendige behandlinger og resepter som er belastet Medicare.) BMJ 2016;353:i3361 (Published 15 June 2016).)

(Anm: Den britiske regjeringen har drevet lobbyvirksomhet overfor EU-kommisjonen for å få vedtatt en mer avslappet tilnærming til reguleringer av legemidler, medisinsk utstyr og mat, ifølge et brev som BMJ har fått tilgang til. (The UK government has been lobbying the European Commission to adopt a more relaxed approach to regulating drugs, devices, and food, a letter seen by The BMJ has shown.) BMJ 2016;353:i3357 (Published 15 June 2016).)

(Anm: Gruppe (Transparency International) ber om flere tiltak for å takle korrupsjonen innen legemiddelindustrien. (Group calls for more to be done to tackle corruption in the pharmaceutical industry) (…) På begynnelsen av 2016 har én av 10 korrupsjonsundersøkelser i USA involvert legemiddelfirmaer, hvilket ifølge rapporten er et langt høyere antall saker enn det som involverer banksektoren. BMJ 2016;353:i3099 (Published 02 June 2016).)

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

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

- Hvordan kan vi få høy kvalitet på rutinedata for å overvåke sikkerheten for enheter og prosedyrer?

How can we get high quality routine data to monitor the safety of devices and procedures? (Hvordan kan vi få høy kvalitet på rutinedata for å overvåke sikkerheten for enheter og prosedyrer?)
BMJ 2013;346:f2782 (7 May 2013)
Following recent problems with some medical devices, Bruce Campbell, Andrew Stainthorpe, and Carole Longson suggest some pragmatic steps to improve safety data

Difficulties with medical devices and discussions at the European Commission about new regulations have focused attention on how to introduce devices and procedures safely.1 2 Both medical devices and new procedures are typically introduced with little evidence from clinical trials or observational data. The regulatory requirements for research evidence on the efficacy and on the short and long term safety of new devices are universally less stringent than those for medicines.3 To protect patients from harm we need to gather as much information as possible about adverse events; for implanted devices the data should be over the long term.4 Recent events such as the Poly Implant Prothèse (PIP) breast implant scandal show that data gathering is still not happening as it should. We examine the reasons for inadequate collection of data and explain what steps might be taken to improve it. (...)

- Første gjennomgang, som er basert på "totaliteten av bevis," er publisert

YODA and truth seeking in medicine
Editorial
BMJ 2013;347:f4251 (2 July 2013)
Making sense of the curious case of rhBMP-2

Last month, Annals of Internal Medicine published a package of articles unveiling the first fruits of the Yale University Open Data Access (YODA) project. At the core of this novel concept is the idea of a coordinating organization—YODA—simultaneously commissioning two independent systematic reviews of patient level data for a medical product, and subsequently offering the data to researchers more broadly.1 2 3 4 5 (...)

Despite the under-reporting, interpretations about treatment effect based on patient level data and unpublished internal reports were no different from those based on published data alone. Although it is somewhat reassuring that in this particular case the published literature did not misrepresent what is known about the relative effectiveness of rhBMP-2 versus iliac crest bone grafting, it does not excuse under-reporting, and in other cases the situation could have been different.

But the safety of rhBMP-2 remains an open question. Only 23% of all adverse events recorded in the trials were mentioned in journal publications.9 Even with all the data, neither review reached strong conclusions about the safety of rhBMP-2, although both reviews identified a possible increased risk of harms such as cancer. The reviewers reported that safety data were not systematically collected in the trials and adverse events were classified using Medtronic’s own non-standardized “in house” coding system (developed in partnership with the Food and Drug Administration).9 (...)

First reviews are published that are based on the “totality of the evidence” (Første gjennomgang, sm er basert på "totaliteten av bevis," er publisert)
BMJ 2013;346:f3909 (17 June 2013)
Forskere og medisinske utgivere har innledet "et historisk øyeblikk for åpen forskning" etter at en medisinsk utstyrsprodusent ga forskerne enestående tilgang til alle data som de hadde på et av sine produkter for uavhengig evaluering. (Scientists and medical publishers have heralded “a historic moment for open science” after a medical device company gave researchers unprecedented access to all the data they had on one of their products for independent evaluation.)

The reviews were done by two independent teams using the same data. They both found that recombinant human bone morphogenetic protein 2 (rhBMP-2), an orthobiological agent used in some surgeries to promote bone growth, shows little benefit in spinal fusion compared with iliac crest bone graft or other bone grafts, and that it may cause more harms.

Resultatene er publisert i Annals of Internal Medicine, og er basert på data på pasientnivå fra kliniske studier utført av Medtronic, som ble delt med forskere via Yale University open data access (YODA)-prosjekt. 1 2 (The findings are published in the Annals of Internal Medicine and are based on patient level data from clinical trials conducted by Medtronic, which were shared with researchers through the Yale University open data access (YODA) project.1 2)

The data are now being made available to others who want to examine them to answer further scientific questions.

In an editorial, the YODA team praised the work that led to the first ever reviews being published that are based on the “totality of the evidence” and created a new standard in medicine.3

They added: “Let us resolve to have this effort be the first step in the next era of cooperation among industry, academia, clinicians, and the public—one that rewards data sharing, promotes open science, and ultimately makes it untenable to obscure data relevant to the risks and benefits of approved medical products.” (...)

- En tredjedel av de totale kneproteser i USA er "ikke formålstjenlig"

One third of total knee replacements in US are 'inappropriate'
medicalnewstoday.com 30.6.2014
One third of total knee replacements in the US are "inappropriate" when applied to a Spanish patient classification system, according to a study published in Arthritis & Rheumatology, a journal of the American College of Rheumatology.

Figures from the Agency for Healthcare Research and Quality show that more than 600,000 knee replacements are performed each year in the US. This surgery has become increasingly more common over the past 15 years, with studies showing a 162% annual volume increase in Medicare-covered knee replacement surgeries during 1991-2010.

Experts are divided on the reasons for this growth, with some maintaining it demonstrates that the procedure is effective, while others argue the surgery is being overused. One concern of the critics who believe total knee arthroplasties (TKA) are being overused is that the procedure "is highly reliant on subjective criteria."

For the new study, researchers from Virginia Commonwealth University in Richmond examined the criteria that is used to determine appropriateness for TKA.

The authors point out that the investigated criteria have not been studied in the US and have been developed in other countries. (…)

(Anm: Using a validated algorithm to judge the appropriateness of total knee arthroplasty in the United States: A multi-center longitudinal cohort study Arthritis & Rheumatology 2014 (DOI: 10.1002/art.38685).)

(Anm: New study of patients receiving physical therapy following total knee replacement raises new concerns over referral for profit. (medicalnewstoday.com 26.2.2016).)

- Kommentarer: Europa trenger en sentral, transparent, og bevisbasert reguleringsprosess for utstyr

Commentary: Europe needs a central, transparent, and evidence based regulation process for devices (Kommentarer: Europa trenger en sentral, transparent, og bevisbasert reguleringsprosess for utstyr)
BMJ 2013;346:f2771 (7 May 2013)
Last September, the European Commission published proposals to update regulations for medical devices in order to improve patient safety.1 The proposals are being discussed by the European parliament where critical debate is being led by the Committee on Environment, Public Health and Food Safety. (...)

NHS can help foster safe and innovative medical devices, says report (NHS kan bidra til å fremme trygt og nyskapende medisinsk utstyr, iføle rapport)
BMJ 2013;346:f4007 (20 June 2013)
Two UK academies have called for an overhaul of the way medical devices are assessed for safety and performance in Europe, adding that meaningful trials could be done in the NHS.

The Royal Academy of Engineering and the Academy of Medical Sciences held a round table meeting in January to establish the evidence for assessing medical devices. Included were clinicians, engineers from healthcare, and representatives of the industry, academia, funding agencies, and regulators. (...)

- Pasienter sviktes av dårlig kontroll av utstyr, advarer kirurger

Dømt for brystimplantat-svindel
dagensmedisin.no 10.12.2013
Grunnleggeren av det franske selskapet PIPs er dømt til fire års fengsel for salg av potensielt giftige brystimplantat.

Tirsdag ble Jean-Claude Mas (74), grunnleggeren av Poly Implant Prothèse (PIP), dømt i en fransk domstol til fire års fengsel for svindel, ifølge VG.

Implantatene ble solgt over hele verden.

Om lag 300.000 kvinner i 65 land, blant dem Norge, skal ha fått operert inn PIP-implantater. I 2011 kom det frem at disse implantatene hadde dobbelt så stor risiko for å sprekke, sammenlignet med tilsvarende produkter fra andre selskaper.

I februar i fjor konkluderte en europeisk ekspertgruppe med at foreliggende data ikke ga grunnlag for å konkludere om det er noen helserisiko for kvinner som har fått satt inn såkalte PIP-brystimplantater. (...)

(Anm: Det blev ingen strafflindring för Jean-Claude Mas, grundaren av bolaget Poly Implant Prothèse (PIP). Den 76-årige Mas dömdes redan 2013 till fyra års fängelse, permanent näringsförbud och böter på cirka 700 000 kronor. Domstolen ändrade inte heller de överklagade straffen för fyra andra PIP-direktörer. (dagensmedicin.se 3.5.2016).)

Patients are let down by poor device regulation, warn surgeons (Pasienter sviktes av dårlig regulering av utstyr, advarer kirurger)
BMJ 2012;345:e7221 (25 October 2012)
Pasienter blir "sviktet" av dårlig kontroll av hofteproteser og annet medisinske utstyr, som tillaterat potensielt farlige produkter kommer ut på det europeiske markedet, advarer Royal College of Surgeons i dag. (Patients are being “failed” by the poor regulation of hip prostheses and other medical devices, which is potentially allowing dangerous products onto the European market, the Royal College of Surgeons warns today.)

In a letter to the Daily Telegraph the college and the British Orthopaedic Association warn that revelations in a joint BMJ and Daily Telegraph investigation about the system are a “stark reminder” of the “urgent need to address the regulatory flaws.”

The investigation today discloses that the regulation of European medical products is also being “sub contracted” to Asian firms.1

One of the firms (ITC), based in Seoul, said that it had a 100% success rate and “there was no case . . . which [is] rejected.” (...)

Device licensing bodies sometimes put business before safety, an investigation finds (Myndighetenes kontrollorganer som gir tillatelser setter noen ganger forretninger foran sikkerhet, viser en granskning)
BMJ 2012;345:e7138 (25 October 2012)
Some of the 76 “notified bodies” that are charged with evaluating the safety and reliability of clinical devices for use in the European Union have been exposed as being more interested in attracting business than guarding the safety of patients.

The BMJ and the Daily Telegraph conducted a “secret shopper” exercise to test the processes that notified bodies use for assessing devices on behalf of national and EU regulators.1 These are commercial enterprises and issue CE certificates (signifying compliance with European standards) for toys and toasters as well as medical devices.

For the exercise the BMJ and the Daily Telegraph created an imaginary, large diameter metal on metal hip prosthesis similar to an implant that was recalled after it was found to have unacceptably high failure rates and to have released metal ions into patients’ blood. Reporters took a glossy brochure on the hip implant to 14 notified bodies in five countries and applied to get quotations for CE certification. (...)

The scandal of medical device regulation (Skandalen med regulering av medisinsk utstyr)
EDITOR'S CHOICE
BMJ 2012;345:e7180 (24 October 2012)
Try describing Europe’s system for regulating medical devices and, as Peter McCulloch says in his editorial this week, the response from your audience will be incredulous (doi:10.1136/bmj.e7126). Read his description and see if you too find yourself asking, “How could this have come about?” It’s a question that now demands urgent remedy. If this was not already clear from recent BMJ investigations (BMJ 2011;342:d2748, BMJ 2012;344:e1410), a new investigation makes it uncontrovertibly so. Working with undercover reporters from the Telegraph newspaper, the BMJ’s Deborah Cohen has exposed a fragmented, poorly regulated, market driven system, with financial incentives to prioritise manufacturers’ interests over those of patients, and with no requirement for clinical evaluation of a device’s safety or effectiveness (doi:10.1136/bmj.e7090).

Armed with a fictitious hip implant modelled on one that was recalled on safety grounds in 2010, the reporters approached 14 of the 78 “notified bodies” to which the European Union delegates the job of certifying medical devices. The one to which they eventually submitted their glossy dossier was happy with the design and confirmed that it would approve the device subject to manufacturing documents and a factory visit. (...)

Medical Device Regulation
How a fake hip showed up failings in European device regulation
(Hvordan en falsk hofte avdekket mangler hos europeisk kontrollorgan for utstyr)
BMJ 2012;345:e7090 (24 October 2012)
Deborah Cohen investigates how EU authorities would be prepared to allow a fake hip prosthesis with dangerous design flaws onto the market

The Changi TMH (total metal hip) does not exist. It is a large diameter metal-on-metal hip prosthesis invented by the BMJ and the Daily Telegraph to test Europe’s systems for regulating high risk medical devices. It was modelled on an implant that has been described as one of the biggest disasters in orthopaedic history.

In our submission to gain market entry, our fictitious company, Changi, explicitly stated that the device was similar to three controversial implants. Two of these have been recalled by their manufacturers and two are subject to legal action in the United States. And even though the dossier we created said that tests had shown that our hip prosthesis produced potentially toxic levels of metal ions in the body, the implant was passed as having an acceptable design for use in patients across Europe. (...)

Revnede brystimplantater gir nye EU-regler
vg.no 26.9.2012
SKANDALE: Flere hundre av implantatene fra den franske produsenten revnet og måtte opereres ut.

Som følge av skandalen rundt defekte brystimplantater vil EU-kommisjonen nå skjerpe kontrollen med medisinsk utstyr. Regelendringen vil også gjelde for Norge.

Det ble i fjor kjent at flere hundre tusen kvinner har fått operert inn såkalte PIP-implantater av dårlig kvalitet. EU ble kritisert for å ha for svake regler for medisinsk utstyr og legger nå opp til et skjerpet regelsett.

- For bare noen måneder siden ble alle sjokkert over skandalen rundt brystimplantater som gjaldt flere titusener kvinner i Europa og rundt om i verden, sa helsekommissær John Dalli da han onsdag la fram forslaget.

- Vi må gjøre det vi kan for at dette aldri skjer igjen, fortsatte han. (...)

FDA proposes tightening post-market oversight of medical devices (FDA foreslår å skjerpe tilsynet av medisinsk utstyr etter markedsføring)
BMJ 2012;345:e6140 (11 September 2012)
The US Food and Drug Administration is proposing additional steps to strengthen the post-market surveillance of medical devices. The FDA’s recommendations were made public in a report released on 6 September.1

“A medical device postmarket surveillance system should quickly identify poorly performing devices, accurately characterize and disseminate information about real-world device performance, including the clinical benefits and risks of marketed devices, and efficiently generate data to support premarket clearance or approval of new devices and new uses of currently marketed devices,” says the introduction to the report. (...)

Watchdog group says “massive lobbying effort” by medical device industry threatens public health (Vaktbikkje-gruppe sier "massiv lobbying-innsats" av produsenter av medisinsk utstyr truer folkehelsen)
BMJ 2012;344:e1521 (28 February)
A watchdog group says that the medical device industry has lavished millions of dollars on US politicians in a “massive lobbying effort” to promote legislation that will weaken oversight of the industry and endanger the public.

The charges were made on 15 February by Public Citizen, a non-profit watchdog organisation based in Washington, DC, during a Congressional hearing on the Medical Device User Fee Act. Consumer groups and industry representatives clashed during the hearing on the proposed legislation, which was hammered out after a year of negotiations between the industry and the Food and Drug Administration. (...)

UK medical device regulation is criticised as both cumbersome and inadequate (Britisk kontroll av medisinsk utstyr kritisert for å være både besværlig og mangelfull)
BMJ 2012;344:e1202 (17 February)
Medical device regulations were criticised last week by manufacturers who make devices and doctors who use them.

At a press briefing on 16 February, manufacturers said the regulations were unnecessarily cumbersome, while doctors criticised them for being inadequate and subject to conflicts of interest. The recent breast implant affair may have brought the issue to public attention, but medical professionals and manufacturers alike say they have been questioning the system for years. (...)

Europe is updating rules on medical devices after implant fiasco (Europa oppdaterer regler for medisinsk utstyr etter implantatfiasko)
BMJ 2012;344:e766 (30 January)
Pressure is growing for stricter European controls on medical devices and better traceability after the discovery of defective silicone gel breast implants manufactured by the French company Poly Implants Prosthèses (PIP).

The European Commission, after being questioned by a British Labour member of the European parliament, Linda McAvan, confirmed last week that it is working on updating existing medical devices legislation that came into force in March 2010.

While welcoming the move, Mrs McAvan suggested that because many women are unsure whether their breast implants are defective, unique identification of products could ensure effective tracking in future. With up to 500 000 women (mostly outside the European Union) affected, the Labour MEP also emphasised the need for better international cooperation.

The Belgian Liberal MEP Fréderique Ries also called on the commission to request a study into the possible health risks of silicone implants in general.
The commission had already begun assessing how to update the existing medical devices legislation two years before the French authorities became aware of the defective implants in early 2010 and is expected to present proposals before the end of June. (...)

(Anm: Hofteproteser (Boneloc, ASR etc.) (mintankesmie.no).)

Medical Device Regulatory Reform
Insights From the Watchman Left Atrial Appendage Closure Technology for Stroke Prophylaxis in Atrial Fibrillation

Arch Intern Med. 2011;171(18):1670-1672 (October 10)
(...) Medical devices play an increasingly prominent role in modern health care delivery. Medical devices that potentially pose an unreasonable risk of illness or injury (Class III devices) are currently approved by the US Food and Drug Administration (FDA) via 2 major regulatory pathways. Low- to medium-risk devices require evidence of substantial equivalence to a predicate device, as determined by the 510(k) process. High-risk devices require a confirmatory study to support a premarket approval (PMA) application based on valid scientific evidence that there is reasonable assurance that the device is safe and effective.

Although by necessity the regulatory framework for device approval is different from that of drug approval, there are increasing concerns that the regulatory standards for approval are less stringent for devices than for drugs. It is claimed that devices are often approved based on studies that lack adequate strength and may be prone to bias. Herein, we briefly review the nonapproval decision by the FDA for the Watchman (Atritech Inc, Plymouth, Minnesota) left atrial appendage closure device for stroke prevention in patients with nonvalvular atrial fibrillation (hereinafter, "Watchman"). Important insights gained from the Watchman experience are utilized to instantiate a proposal for greater rigor, clarity, efficiency, and transparency in device evaluation, approval, and surveillance. (...)

Medical Devices — Balancing Regulation and Innovation (Medisinsk utstyr — Balansere regulering og innovasjon)
NEJM 2011 (August 10)
Many Americans benefit from the implantation of medical devices, such as artificial joints and lifesaving defibrillators. Tragically, many also suffer or even die from complications related to medical devices that were never studied in clinical trials before being implanted in patients. As devices have evolved and become more complex, our device-approval system has become incapable of assuring safety and effectiveness. The system we use today was created 35 years ago in an era of much simpler and fewer devices, and it is now outdated. (...)

Clinical data on high risk medical devices should be made publicly available (Kliniske data for høyrisiko medisinsk utstyr bør gjøres offentig tilgjengelige)
BMJ 2011; 342:d4162 (30 June)
Doctors and patients should have access to information on clinical trial data used to approve high risk medical devices so that they can make informed decisions about the devices they use, a WHO agency says.

In a report the Belgian Health Care Knowledge Centre recommends that the EU Medical Devices Directive should be adapted to require all manufactures of high risk medical devices to carry out “high quality randomised trials . . . with clinically relevant endpoints.” (...)

The trouble with medical devices (Problemet med medisinsk utstyr)
BMJ 2011; 342:d3123 (18 May)
In 1993 a BMJ editorial warned of the “fashion trade” in joint replacements (BMJ 1993;306:732). It said this was costing health services many millions of pounds each year and causing patients pain and distress through early failure of unproved implants. This week an investigation by the BMJ and Channel 4 Dispatches shows how right this view was and how little has changed. (...)

The story makes uncomfortable reading. It shows how poorly we evaluate and regulate medical devices (doi:10.1136/bmj.d2748). It shows the flaws in a system that, as Nick Freemantle comments (doi:10.1136/bmj.d2839), might be ok for toasters and kettles but is completely inadequate for treatments that affect patients’ quality of life and can cause their death. It also shows, as Matthew Thompson and colleagues describe, the lack of transparency over what tests are done before a device is approved (doi:10.1136/bmj.d2973). A recent study in the United States analysed data on devices recalled from the market. In their study just published in BMJ Open (http://bmjopen.bmj.com/content/early/2011/05/12/bmjopen-2011-000155.abstract), Thompson and colleagues tried to replicate the study in the UK. They found it impossible. The US Food and Drug Administration publishes a list of devices on the market and says what regulatory processes these had passed through. No such information is available from the UK’s Medicines and Healthcare products Regulatory Agency. The Freedom of Information Act is trumped by laws that protect commercial confidentiality. (...)

Group Faults the F.D.A. on Oversight of Devices (Kontrollorgan kritiserer FDAs tilsyn med utstyr)
nytimes.com 12.4.2011
The Food and Drug Administration is allowing some high-risk devices like artificial hips to be sold without strenuous testing, despite promises that it would address regulatory issues affecting them, a federal watchdog group plans to testify on Wednesday.

The group, the Government Accountability Office, found that the F.D.A. has taken some recent steps to determine if certain high-risk medical devices should undergo more testing before being sold. But in the meantime, it is continuing to approve dozens of such devices annually with scant review, exposing patients to risks. (...)

FDA Criticized Over Device Approvals (FDA kritisert for godkjenning av utstyr)
online.wsj.com 17.2.2011
WASHINGTON—-Congressional Republicans criticized the Food and Drug Administration on Thursday over medical-device approvals, saying the clearance process has become so slow and unreliable that device makers are moving to Europe and taking jobs with them.

An FDA official challenged those assertions during a House hearing and said the European system lacks safety checks. He was joined by two prominent doctors who said that in the wake of recent device recalls, including some linked to serious injuries and deaths, the FDA must review its use of a short-cut clearance program. The program is popular with industry, which doesn't want it restricted. (...)

Study: Harmful Medical Devices Got FDA Approval Too Easily (Studie: Skadelig medisinsk utstyr får FDA-godkjenning for lett)
healthfinder.gov 14.2.2011
CHICAGO – Most medical devices recalled in recent years because of deaths or life-threatening problems were cleared for approval under less stringent regulations that don't require human testing, an analysis found.

The report comes as the Food and Drug Administration is reviewing sweeping proposals to revise the medical device approval process. The studied devices fell under rules for products similar to ones on the market, not regulations for brand new ones, which call for more extensive testing.

Thousands of deaths or serious medical problems occurred in patients with the recalled devices, which included external heart defibrillators, brain shunts and implanted pumps that deliver cancer drugs, the researchers said. (...)

FDA spokeswoman Karen Riley said the study's findings aren't new and noted that the recalls it highlighted represent a small portion of the more than 19,000 devices cleared through the less strict standard during those years.

The report appears in Monday's Archives of Internal Medicine. An editorial says the analysis shows that "millions of Americans may be at risk for device-related injuries and recalls from high-risk devices that were cleared by FDA without any supporting clinical trial data." (...)

(Anm: Medical Device Recalls and the FDA Approval Process. Arch Intern Med. 2011 (Published online February 14).)

(Anm: Comment on "Medical Device Recalls and the FDA Approval Process" Arch Intern Med. 2011 (Published online February 14).)

Regulation of devices (Regulering av utstyr)
BMJ 2010; 341:c5730 (2 November)
Lessons can be learnt from drug regulation

The development, approval, and surveillance of medical devices have some features in common with those for prescription drugs, as well as others that are even more challenging. Yet the regulatory traditions of the device world are strikingly different from those of drugs and often much more problematic. This is shown in the linked feature by Lenzer and Brownlee (doi: 10.1136/bmj.c4753), which describes the history of a vagus nerve stimulator to treat epilepsy—a device with a worrying risk-benefit ratio.1 (...)

Why the FDA can’t protect the public (Hvorfor FDA ikke kan beskytte publikum)
BMJ 2010; 341:c4753 (2 November)
Medical device makers often fail to properly conduct safety studies and the US Food and Drug Administration provides scant oversight. Jeanne Lenzer and Shannon Brownlee look at some of the problems with post approval surveillance of novel devices (...)

Grassley Questions FDA on Med Device Approval (Grassley stiller spørsmål om godkjenning av medisinsk utstyr)
dotmed.com 22.2.2010
Senator Charles Grassley (R-IA), Senate Finance Committee Ranking Member, has asked the U.S. Food and Drug Administration (FDA) for updates on new guidelines for medical device makers in the marketing and use of modified devices under the FDA's 510(k) system. (...)

FDA May Tighten Rules for Medical Devices
businessweek.com 18.2.2010
More stringent safety regulations for medical devices are being considered by the U.S. Food and Drug Administration, which will get input from manufacturers, doctors and consumer advocates at a meeting Thursday.

If device approval rules are tightened, experts say it could mean more time and money for companies looking to market devices such as pacemakers, heart valves, drug pumps and hip replacements, the Associated Press reported. (...)

Science and Lobbying at the F.D.A. (Vitenskap og lobbyvirksomhet hos FDA)
EDITORIAL
nytimes.com 3.10.2009
The Food and Drug Administration, newly energized under the Obama administration, has now admitted that it capitulated to political pressure when it approved a knee-repair device in the waning days of the Bush administration. (...)

FDA device chief resigns following complaints (FDAs utstyrsjef går av etter klager)
businessweek.com 11.8.2009
The head of the Food and Drug Administration's medical device division is stepping down, months after staff scientists alleged they were pressured to approve certain products.

In a letter to agency staffers, Daniel Schultz says he and FDA Commissioner Margaret Hamburg agreed his resignation "would be in the best interest of the center and the agency."

FDA's device division, which Schultz led for five years, has been under scrutiny since earlier this year when nine scientists wrote to the Obama administration transition team complaining they were pressured to approve medical devices against their professional judgment.

Lawmakers are investigating the complaints. (...)

FDA Tells Drug and Device Makers to Give Balanced Picture of Risks in Ads, Labels
JAMA. 2009;301(24):2541. (June 24)
The US Food and Drug Administration (FDA) is advising the makers of medications and medical devices to avoid misleading consumers with marketing strategies that deemphasize the risks of these products.

Promotional materials that omit or minimize risk information are the most frequent reason the agency issues enforcement letters to companies, and the FDA says it has received requests from industry for clarification about what it considers a violation. In the new guidance (http://www.fda.gov/cder/guidance/7427dft.pdf), the agency emphasizes that simply including risk information is not enough to satisfy its requirements; rather, the agency weighs whether marketing materials leave consumers or clinicians with a balanced impression of a product's risks and benefits. (...)

To Review Safety, Effectiveness of Some Older Medical Devices
kaisernetwork.org 9.4.2009
FDA on Wednesday announced it will ask several medical device manufacturers to submit data detailing the safety and effectiveness of some of their products already available on the market, the New York Times reports. The manufacturers will have 120 days to submit the data (Harris, New York Times, 4/9). (...)

Political Lobbying Drove FDA Process (Politisk lobbying drev FDA-prosess)
online.wsj.com 6.3.2009
WASHINGTON -- Den nylige godkjennelsen av nytt utstyr for behandling av kneskader fulgte en lobbykampanje, som ifølge dokumenter, seiret over gjentatte avslag fra forskere innen FDA. (The recent approval of a new device to treat knee injuries followed a lobbying campaign that overcame repeated rejections by scientists within the Food and Drug Administration, agency documents show.)

FDAs interne uenighet om Menaflex, som brukes ved de mest vanlige kneskader som rammer alt fra unge idrettsutøvere til eldregenerasjonen, setter press på et statlig tilsynsorgan som har ansvaret for en fjerdedel av den amerikanske økonomien. Det fremgår at enkelte seniorledere hos FDA i dokumenter klaget over håndteringen av Menaflex, produsert av ReGen Biologics Inc., som viser hvordan politisk press fra industrien kan påvirke vitenskapelige konklusjoner. (...) (The FDA's internal dissent over Menaflex, which targets the most-common knee injury afflicting everyone from high-school athletes to baby boomers, is straining a government agency that oversees a quarter of the U.S. economy. Some senior FDA staff members complained in documents that the handling of Menaflex, made by ReGen Biologics Inc., shows how political and industry pressure can influence scientific conclusions.)

Spørsmålet går ikke bare på utstyrets effektivitet -- som fortsatt er omstridt -- men måten FDA gjennomfører egen godkjenningsprosess.(...) (At issue isn't just the efficacy of the device -- that remains in dispute -- but the nature of the FDA's own approval process.)

Is That Device Safe? (Er det derre utstyr trygt?)
nytimes.com 26.1.2009
The Food and Drug Administration has been justly pilloried for grievous flaws in its regulation of foods and drugs. Now Congressional investigators, and some of the agency’s own scientists, are charging that the F.D.A. has failed to adequately regulate medical devices. (...)

High risk medical devices escaped close review (Medisinsk utstyr med høy risiko godkjennes uten full gjennomgang)
yahoo.com/s/ap 16.1.2009
WASHINGTON – En hel del sensitivt utstyr, fra bestemte hofteledd til en type hjertestarter, har fått statlig godkjennelse uten en nøye vitenskapelig gjennomgang, ifølge kongressens granskere torsdag. (– Some medical devices for sensitive uses, from certain hip joints to a type of defibrillator, have won government approval without a close scientific review, congressional investigators said Thursday.)

Although Congress ordered the Food and Drug Administration years ago to resolve the issue, the agency approved 228 medical devices without a full scale review from 2003-2007, the Government Accountability Office said in a report.

Some devices approved under the less rigorous process have been recalled because of malfunctions and other problems, according to the consumer group Public Citizen. One device was an external defibrillator to assist heart attack victims.

Rapporten kommer idet FDAs Center for Devices and Radiological Health er gjenstand for påstander om at forskere er presset til å godkjenne medisinsk utstyr mot sine profesjonelle vurderinger. Ni forskere hos FDA skrev til Obamas overgangsteam sist uke og klaget på en "korrumpert" tilsynsprosess som setter folks liv i fare. (...) (The report comes as the FDA's Center for Devices and Radiological Health is the subject of allegations that scientists were pressured to approve medical machinery against their professional judgment. Nine FDA scientists wrote the Obama transition team last week complaining that a "corrupted" review process is putting public health at risk.)

F.D.A. Criticized on Device Approvals (FDA kritisert for godkjenninger av utstyr)
NYTIMES.COM 15.1.2009
WASHINGTON — Nearly two decades after Congress mandated that all high-tech medical devices be thoroughly reviewed before being approved for sale, the Food and Drug Administration still approves most such devices after minimal testing and perfunctory review. (...)

FDA Whistleblowers (FDA-varslere)
JAMA. 2009;301(2):152 (January 14)
A group of scientists within the Food and Drug Administration's (FDA’s) Center for Devices and Radiological Health (CDRH) said some of their managers corrupted the scientific review process and approved or cleared medical device applications in gross violation of federal laws and regulations. (...)

Internal Documents Show Scientists' Concern About Agency's Approval Process for Medical Devices, New York Times Reports
kaisernetwork.org 13.1.2009
Some FDA scientists have criticized the agency's approval process for medical devices, saying that many of the products receive approval without undergoing significant scientific testing, according to internal agency documents, the New York Times reports. The Times obtained the documents, including e-mails and other memorandums, which are being used as part of an ongoing internal agency probe into complaints from nine agency scientists about device approval methods and other issues at FDA's Office of Device Evaluation. (...)

In F.D.A. Files, Claims of Rush to Approve Devices
nytimes.com 12.1.2009
An official at the Food and Drug Administration overruled front-line agency scientists and approved the sale of an imaging device for breast cancer after receiving a phone call from a Connecticut congressman, according to internal agency documents. (...)

- Danske læger, der har indopereret en farlig hofteprotese, er sponseret af producenten bag

Medicoindustri har frit slag over for læger
business.dk 7.2.2012
Mens almindelige praktiserende læger ikke må tage imod selv de mindste gaver fra lægemiddelindustrien, så er der næsten ingen regler for, hvad læger må modtage fra producenter bag medicinsk udstyr.

Se også

Medicinalindustri klar til at droppe gaver
Læger efterlyser skrappere regler om bivirkninger
FN strides om farma-industriens patenter
Lundbeck afviser at blande sig i uvildig forskning
Dansk firma i bestikkelsessag

Men det skal der laves om på, mener flere politiske partier, efter DRs TV-Avisen har afsløret, at danske læger, der har indopereret en farlig hofteprotese, er sponseret af producenten bag.

"Vi har for tit set læger, der har nogle økonomiske interesser og der skal der være gennemsigtighed", siger sundhedsordfører Liselott Blixt (DF).
Som loven er i dag, må læger maksimalt få gaver på op til 300 kroner fra lægemiddelindustrien. Desuden skal lægerne søge om tilladelse hos lægemiddelstyrelsen, hvis de vil udføre konsulentarbejde eller på nogen måde samarbejde med lægemiddelindustrien. Al tilknytning offentliggøres på internettet.

Men intet af alt dette gælder, når lægerne samarbejder med medicoindustrien.

"Jeg synes, vi skal tage det samme regelsæt, vi har fra medicinområdet, hvor der findes nogle regler om sponsorater og samarbejde med industrien," siger sundhedsordfører Benedikte Kiær (K).

Oven i købet har de almindelige praktiserende læger, strammet deres egne etiske regler så meget, at de end ikke må tage imod små gaver som en kuglepen.

Og deres formand mener, at den nuværende lovgivning også burde gælde, når læger arbejder sammen med medicoindustrien.

"Som læger er det vigtigt, at vi står som uvildige i de situationer, hvor vi har med patienterne at gøre. Det gør vi bedst hvis der er klare og sikre regler", siger formand for de praktiserende læger Henrik Dibbern. (...)

Lægerne spiller ofte andenviolin på medico
dagenspharma.dk 7.2.2012
En stribe af nye afsløringer om relationerne mellem læger og medicoindustrien har fået alle op på barrikaderne.

Lægeforeningen og politikerne er rørende enige om at medicoindustrien skal sidestilles med medicinalindustrien, når det gælder at oplyse relationerne mellem lægerne og industrien.

Men det var ærligt taget en gratist:

Det ligger direkte i det udvalg som Sundhedsministeriet, at vi skal se på disse relationer.

Men problemet med de medicotekniske beslutninger er næppe lægelige. I hvert tilfælde ikke altid.

Nej, ofte er det administratorer, indkøbere, som industrien logrer for. Disse personalegrupper burde man sandelig også interessere sig for og deklarere deres relationer til industrien.

De bestemmer ofte langt mere end lægerne, når det gælder indkøb af udstyr. Skal de så ikke have deres egen database på Lægemiddelstyrelsens hjemmeside, lige som lægerne.

Det er mindst lige så relevant. (...)

- Defekte implantater, skumle legemidler og en tannløs vaktbikkje som svikter pasienter

Faulty implants, dodgy drugs and a toothless watchdog that's failing patients (Defekte implantater, skumle legemidler og en tannløs vaktbikkje som svikter pasienter)
dailymail.co.uk 10.1.2012
Just over two years ago consultant plastic surgeon Azhar Aslam became deeply worried — he’d had to remove eight silicone breast implants from women within a few months of each other because they had ruptured prematurely.

It struck him as highly unusual.

‘If implants do rupture, it is normally after seven to ten years, and it is usually caused by an impact, such as the wearer falling over or having a car accident,’ he says.

Last week, the Medicines and Healthcare products Regulatory Agency (MHRA) admitted the safety of breast implants was actually impossible for it to judge
‘But these implants had failed after only two to three years, and the patients had not been involved in any impact.’ (...)

The agency’s initial response to fears over the implants was to say the failure rate was only 1 per cent.

Then, last week, the MHRA admitted the safety of breast implants was actually impossible for it to judge, because an accurate record of the number of procedures has not been kept.

Clinics were blamed for this failing, with Health Secretary Andrew Lansley criticising them for providing ‘poor quality’ data. (...)

Sadly, this is not the first time the agency has been criticised for acting slowly and ineffectually.

In September 2010, for instance, the diabetes drug Avandia was finally banned in Britain after the European Medicines Agency ruled there was a serious risk it could lead to heart attacks or stroke.

Evidence against Avandia had been building since 2007. (...)

The MHRA did not reveal this warning to the public; it simply passed its information on to European authorities.

A few years earlier, media pressure was required to force the MHRA to act over another prescribed-drug danger. Again, it was a GlaxoSmithKline medicine — the antidepressant Seroxat. (...)

Vioxx was withdrawn from the market in the UK four years ago, but only after a 2004 U.S. study found it doubled the risk of heart disease
Then, in 2003, following two BBC Panorama programmes, the drug watchdog mounted its own investigation and discovered the manufacturer had hidden information about the suicide link.

After this, the MHRA said it wanted to require drug makers to share more information about clinical trials — but admitted that, without stronger legislation in place, there was no chance of prosecuting the company for what it called an ‘ethical lapse’.

The watchdog was not only asleep, it was toothless.

Similar problems arose with the arthritis painkiller Vioxx. This was withdrawn from the market in the UK four years ago, but only after a 2004 U.S. study found it doubled the risk of heart disease. Leading cardiologists had been flagging up the risks for years.

After Vioxx’s withdrawal it emerged that data from clinical trials had been ‘fudged’.

The MHRA launched an investigation into whether its maker, Merck, had correctly reported the side-effects of Vioxx to the authorities.

But government prosecutors decided that there was no realistic prospect of a conviction in this case.

The MHRA says the UK laws requiring disclosure of negative drug trial results have since been tightened. No companies have been prosecuted since then.
Yet it’s not just the agency’s supervision of drugs that raises concerns, but medical devices, too.

These include crucial items such as heart pacemakers.

Last May, the British Medical Journal (BMJ) said not enough was being done to check the safety of medical implants.

It says that in 2009 the MHRA received more than 9,000 reports of ‘adverse incidents’ involving medical devices.

More than 1,880 of these involved serious injury and 202 resulted in death. In one case, a patient’s combined pacemaker/defibrillator misfired more than 30 times in one day, delivering huge jolts of 750 volts direct to his heart. ¨

The BMJ has said our regulators are not ‘fit for purpose’ because of their failure to act in patients’ interests.

It is these sorts of problems that have led experts such as Andrew Herxheimer to call for the MHRA to be subjected to ‘root and branch reform’.

Dr Herxheimer is an emeritus fellow of the UK Cochrane Centre and a world leader in examining clinical trials to see how well therapies work.

One problem, says Herxheimer, is that the agency’s role is shrouded in confusion.

‘Its job description has not been defined,’ he says.

‘In fact, it seems to be acting as a rather secretive negotiating agency between the government and the pharmaceutical industry.

‘It is certainly too close to the pharmaceutical industry,’ adds Herxheimer. ¨

‘There appears to be a revolving door with people who have previously worked in the pharmaceutical industry coming to work inside the MHRA. ’

Accusations have long been made that the watchdog is too close to industrial interests, notably when Ian Hudson, who was worldwide safety director of GlaxoSmithKline until 2001, became director of licensing at the MHRA.

Nor have the agency’s actions helped assuage these kinds of concerns. (...)

(Anm: Tandsjukdom efter implantat. Nästan var sjätte person som fått tandimplantat drabbas av en allvarlig inflammation i angränsande vävnader, peri-implantit. Det visar en studie vid Sahlgrenska akademin i Göteborg. Studien omfattar 4 716 personer som fick tandimplantat 2003-2004. Nio år efteråt hade 14,5 procent drabbats av peri-implantit, som liknar tandlossning men har ett snabbare och aggressivare förlopp, skriver Dagens Nyheter. De som drabbas behöver ytterligare behandling, vilket kan bli ekonomiskt kännbart. Över 30 000 patienter i Sverige fick förra året nya tänder som skruvas fast i käkbenet. (dagensmedisin.no 28.10.2015).)

(Anm: Antidepressiva er ifølge ny studie knyttet til mislykkede tannimplantater. (Antidepressants linked to tooth implant failure, new study finds.) (- Forskning viser at bruk av antidepressiva firedobler risikoen for implantat svikt. For hvert år dobler antidepressiva risikoen for svikt.) (medicalnewstoday.com 10.3.2016).)

(Anm: Antidepressiva ökar risken för benbrott hos äldre. (…) Den förhöjda risken för höftfraktur gällde alla de vanliga antidepressiva läkemedlen, SSRI-preparat, mirtazapin och SNRI-preparat (selektiva serotonin- och noradrenalinåterupptagshämmare. Sambandet gällde även då det kontrollerats för andra faktorer som ålder, annan medicinering som ökar fallrisken, benskörhet, socioekonomisk status, kroniska sjukdomar och psykiatriska diagnoser.) (lakemedelsvarlden.se 12.1.2017).)

(Anm: Heart disease risk higher with latent tooth infection. If you missed your last dental checkup, a new study might encourage you to book that appointment right away; researchers have identified a higher risk of heart disease for individuals who have hidden tooth infections. (…) Last year, for example, a study published in Infection and Immunity suggested that the bacterium involved in gum disease may also raise the risk of heart disease. Now, researchers from the University of Helsinki in Finland have uncovered a link between dental root tip infection, known as apical periodontitis, and greater risk for acute coronary syndrome (ACS) - an umbrella term for conditions that involve blocked blood flow to the coronary arteries. (medicalnewstoday.com 3.8.2016).)

(Anm: Munhälsan bättre än på 80-talet – men tandlossning ökar igjen. De två största tandsjukdomarna karies och parodontit (tandlossning) minskade fram till 2008. Därefter ökade antalet individer med parodontit och den positiva utvecklingen för karies stannade av. – Även om munhälsan har förbättras under denna 30-årsperiod ser vi en försämring mellan 2008 och 2013 då det gäller främst tandlossning, säger Kristina Edman vid Uppsala universitet har undersökt munhälsans utveckling över en trettioårsperiod. (forskning.se 3.5.2016).)

(Anm: Stimulant Medications Linked to Bone Mass Reductions in Children, Adolescents. BOSTON -- April 6, 2016 -- Use of stimulant medications in the treatment of attention deficit hyperactivity disorder (ADHD) in childhood and adolescence is associated with significant reductions in bone mass, according to a study presented here at the 98th Annual Meeting of the Endocrine Society (ENDO). (…) “We suggest that stimulant medications, which release and block reuptake of dopamine and norepinephrine, may affect bone mass,” said the researchers. (dgnews.docguide.com 6.4.2016).)

- Medicinalgigant hemmeligholdt livsfarlige bivirkninger

Medicinalgigant hemmeligholdt livsfarlige bivirkninger
bt.dk 25.3.2012
Kontrastmiddel dræbte 50 danskere

Michael Madsen er bundet til sin kørestol efter anden dosis af kontrastmidlet Omniscan. En af de ting han savner er at gå en tur med sin gamle førerhund Lakrids.

Mere end 50 danskere er syge og døde af kontrastmidlet Omniscan. B.T. kan i dag fremlægge en hemmeligholdt intern forskningsrapport, som dokumenterer, at producenten GE Healthcare vidste, at midlet ville være livsfarligt for nyresvage patienter.

Alligevel holdt firmaet rapporten hemmelig og forlangte af danske myndigheder, at produktet blev brugt på netop nyresvage patienter.

B.T. dokumenterede allerede sidste år, at producenten GE Healthcare efter alt at dømme vidste, at produktet var skadeligt, men at de hemmeligholdt deres viden overfor danske myndigheder og læger. (...)

LÆS HELE RAPPORTEN HER

Kort om Omniscan-sagen
Kontrastmidlet Omniscan, der oprindeligt blev udviklet af Nycomed, har vist sig at være livsfarligt for patienter med en nedsat nyrefunktion. Produktet sprøjtes ind i patienter ved scanninger for at sikre et godt billede.

Omkring 100 danske patienter er blevet ram af sygdommen nefrogen systemisk fibrose, hvoraf 50 er døde, efter de har fået Omniscan.

I 1998 blev produktet ellers godkendt til brug på nyresvage patienter af Lægemiddelstyrelsen. Den faglige vurdering er siden kritiseret flere gange for at være stærkt mangelfuld og sjusket. Ifølge en advokatundersøgelse har Lægemiddelstyrelsen vildledt og fortiet oplysninger om sagen overfor Folketinget for at dække over sin fejl.

Danske patienter har fået udbetalt knap 20 mio. kr. i erstatning for Lægemiddelstyrelsens fejl.

Det er dog helt nyt, at producenten GE Healthcare tilsyneladende kendte til de skadelige bivirkninger, som var forbundet med Omniscan. (...)

- Å snu flodbølgen av interessekonflikter

Turning the tide on conflicts of interest (Å snu flodbølgen av interessekonflikter)
Editor's Choice
BMJ 2011; 343:d5147 (10 August)
The US Food and Drug Administration says it may loosen its conflict of interest policies (doi:10.1136/bmj.d5070). A shortage of independent experts means that its current rule—no more than 13% of advisers with industry ties—is delaying the introduction of new drugs, says its commissioner. (...)

Back tracking now on conflicts of interest would send the wrong message, especially to the EMA, which has some catching up to do. It still has a reputation for being more on the industry’s side than the public’s, not helped by its outgoing executive director Thomas Lönngren’s revolving door appointment as an adviser to industry (www.pharmatimes.com/Article/11-01-18/Ex-EMA_chief_joins_new_market_access_business.aspx).

WHO too is vulnerable to criticism on this score. A recent report on its handling of the A/H1N1 influenza pandemic concluded that it had not followed its own rules on conflict of interest and that these needed strengthening (BMJ 2011;342:d3378). Now it is under fire for proposals that would increase industry’s influence on how it sets its priorities (doi:10.1136/bmj.d5012). A word of warning to its director general: back in the 1990s, among those telling WHO to stick to its knitting and focus on infectious diseases in the third world were experts covertly funded by the tobacco industry (BMJ 2000;321:314, doi:10.1136/bmj.321.7257.314).

The FDA should stand firm. Not only is the tide turning in its favour, but strong policies are helping to turn the tide. So here’s a question: should the BMJ repeat the NEJM’s experiment and ban editorials and clinical reviews from authors with ties to industry? I’d welcome your views in rapid responses. (...)

(Anm: Gaver, smøring (gave gitt som bestikkelse) etc. (mintankesmie.no).)

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

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

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

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

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

Who watches the watchmen? (Hvem vokter vokterne?)
Nature 2011; 476: 125 (11 August)
I slutten av forrige måned foreslo de amerikanske myndigheter en gjennomgang av reguleringer for forskning på frivillige. Det innbefatter det å tillate enkelte etiske komiteer (Institutional Review boards (IRBs)) å overvåke amerikanske ”multisite” kliniske studier. Slike komiteer understøtter etikk og sikkerhet for et forsøk og gjennomgår alle forskningsprosjekter, protokoller og samtykkeformularer før de blir satt ut i livet. For tiden kan dusinvis eller et tyvetalls IRB-er - en for hvert forsøkssted - separat gjennomgå og godkjenne en klinisk studie og dens nødvendige dokumenter, hvilket fører til et massivt dobbeltarbeid og forsinkelser. (...) (Late last month, the US government proposed an overhaul of regulations covering research on human volunteers. It includes a move to allow single institutional review boards (IRBs) to oversee US multi-site clinical trials. Such boards underpin the ethics and safety of a trial, reviewing all research protocols and consent forms before it is launched. Currently, dozens or scores of IRBs — one for each trial site — can separately review and approve a clinical trial and its necessary paperwork, leading to massive duplication of effort and delays.)

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

FDA is criticised for hinting it may loosen conflict of interest rules (FDA kritisert for å antyde slakkere krav til interessekonflikter)
BMJ 2011; 343:d5070 (8 August)
The US Food and Drug Administration has come under fire for suggesting that it may loosen conflict of interest rules for its advisers, because of a shortage of experts without ties to the drug and medical devices industry.

The FDA’s commissioner, Margaret Hamburg, said that strict rules on conflict of interest implemented in 2008, which limit the proportion of advisory panellists with industry ties to 13%, may be slowing down approvals of products and hindering innovation.

Dr Hamburg told journalists at a meeting held by the non-profit watchdog Public Citizen in Washington, DC, on 25 July that the agency had to be sure it had “subject-matter experts” “for our important decision making,” reported the online news service Bloomberg News (http://bloom.bg/r2QbrF). (...)

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

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

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

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

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

Conflict-of-Interest Rules May Be Relaxed in 2012, Hamburg Says (Kan bli slakkere regler for interessekonflikter i 2012, ifølge Hamburg)
bloomberg.com 25.7.2011
Conflict-of-interest rules restricting scientists with financial ties to drug and device-makers from advising U.S. regulators may loosen next year, said Food and Drug Administration Commissioner Margaret Hamburg.

A 2008 policy limiting researchers who were paid by manufacturers from serving on advisory panels may be curtailing feedback the FDA receives, Hamburg told the advocacy group Public Citizen in Washington today. Changes may come through a renewal of the law letting the agency receive fees from companies such as Pfizer Inc. (PFE) for product reviews.

“We have to be sure that FDA has subject-matter experts that we need for our important decision making,” Hamburg said, adding that the agency also must “prevent inappropriate influence or distortion of information” that may compromise reviews. Patient-advocacy groups and academic researchers have expressed “valid concerns” about the conflict-of-interest policy, prompting an agency rules review, she said.

Republicans in Congress and manufacturers have criticized the pace of FDA reviews as too slow, blaming unanticipated requests for safety information from FDA staff and advisers. (...)

Conflict-of-Interest Rules May Be Relaxed in 2012, Hamburg Says (Kan bli slakkere regler for interessekonflikter i 2012, ifølge Hamburg)
bloomberg.com 25.7.2011
Conflict-of-interest rules restricting scientists with financial ties to drug and device-makers from advising U.S. regulators may loosen next year, said Food and Drug Administration Commissioner Margaret Hamburg.

A 2008 policy limiting researchers who were paid by manufacturers from serving on advisory panels may be curtailing feedback the FDA receives, Hamburg told the advocacy group Public Citizen in Washington today. Changes may come through a renewal of the law letting the agency receive fees from companies such as Pfizer Inc. (PFE) for product reviews.

“We have to be sure that FDA has subject-matter experts that we need for our important decision making,” Hamburg said, adding that the agency also must “prevent inappropriate influence or distortion of information” that may compromise reviews. Patient-advocacy groups and academic researchers have expressed “valid concerns” about the conflict-of-interest policy, prompting an agency rules review, she said.

Republicans in Congress and manufacturers have criticized the pace of FDA reviews as too slow, blaming unanticipated requests for safety information from FDA staff and advisers. (...)

- Opplysninger fra 120.000 norske pasienter lagret ulovlig i USA

Opplysninger fra 120.000 norske pasienter lagret ulovlig i USA
vg.no 28.3.2012
Pasientopplysninger fra over 120.000 pasienter ble hentet ut og lagret i USA av en utstyrsleverandør. Datatilsynet forventer at alle pasientene som er omfattet, blir orientert.

Utstyrsleverandøren GE Healthcare System har ulovlig hentet ut sensitiv informasjon om 126.344 pasienter fra ti forskjellige helseforetak i Norge som et ledd i overvåking av røntgenutstyr. Dette er i strid med norsk pasientlovgivning.

- I løpet av de siste ti årene er dette den største saken som vi har fått til behandling fra helsesektoren i Norge, sier avdelingsdirektør Helge Veum i Datatilsynet til Aftenbladet. (...)

- Medisinsk utstyr må følges opp etter godkjenning, ifølge senator

Medical Devices Need Follow Up After U.S. Approval, Senators Say (Medisinsk utstyr må følges opp etter godkjenning, ifølge senator)
businessweek.com 16.12.2011
Dec. 16 (Bloomberg) -- U.S. regulators would gain greater authority to track the use of devices, such as hip implants from Johnson & Johnson and vaginal meshes made by Boston Scientific Corp., that have sparked thousands of patient lawsuits, under a bill introduced in the Senate.

Under the legislation, the Food and Drug Administration could order companies to conduct safety studies of devices after they’re approved and could grant conditional approvals pending the result of ongoing trials. That would strengthen rules for products approved through the so-called 510(k) system, which now requires companies only to show their devices are similar to those already on the market.

The procedure was used to clear hip implants recalled in 2010 by J&J, the world’s largest maker of medical devices, and vaginal meshes that spurred an FDA warning earlier this year. In July, the Institute of Medicine, a U.S. advisory group, urged the FDA to replace 510(k), saying it didn’t ensure safety.

“Faulty medical devices, especially those implanted in the body, can have disastrous health impacts on patients,” said U.S. Senator Herb Kohl, one of the bill’s three sponsors, in a statement. “This legislation will help ensure that FDA can act quickly and decisively when there’s a problem and that the drive toward getting new technologies to market won’t come at the risk of patient safety.” (...)

Postmarketing Surveillance of Medical Devices — Filling in the Gaps
NEJM 2012 (February 14)
Failures of implantable medical devices, although rare, can carry a substantial risk of serious injury. From 2000 through 2011, more than 150 new high-risk medical devices were approved by the Food and Drug Administration (FDA) through the premarket approval (known as PMA) process, and an additional 600 devices were cleared through the less demanding 510(k) process, in four medical specialty areas (cardiovascular care, neurology, obstetrics and gynecology, and orthopedics; see graph.) The problem that Hauser describes (10.1056/NEJMp1114695) — the erosion of the insulation in St. Jude Medical's Riata leads for implantable cardioverter–defibrillators — highlights the fact that medical devices are complex assemblies of multiple components, and the failure of any single component can lead to unexpected and serious safety problems. Because it is impossible to design an implantable medical device with zero risk of failure, effective systems for monitoring safety after a device is on the market are essential for protecting the public health. Moreover, since incremental changes are made in medical devices throughout their life cycles, it is impractical to prospectively study each change comprehensively before marketing. Balancing the need for robust postmarketing safety monitoring with the need to avoid the stifling of innovation is a prime responsibility of the Center for Devices and Radiological Health (CDRH) at the FDA. (...)

- Et behov for nasjonalt register for medisinsk utstyr

A Need for a Medical Device National Registry (Et behov for nasjonalt register for medisinsk utstyr)
westpalmbeach.injuryboard.com 15.12.2011
It is thrilling to see something positive (and bipartisan) happening in Congress, after so many months of logjams and conflict.

On December 14, 2011, Senators Charles Grassley (R-Iowa), Richard Blumenthal (D-Connecticut), and Herb Kohl (D-Wisconsin) filed a new patient safety bill. This proposed legislation would require medical device and implant manufacturers to maintain an implant registry so that long-term safety and performance issues can be tracked.

This is not a new idea, as something similar was proposed nearly 20 years ago when a number of women suffered catastrophic injuries and systemic disease due to rupture and leakage of their breast implants. Previous efforts to pass this type of legislation, including the National Knee and Hip Replacement Registry Act of 2009, have failed. The FDA, however, has spent a great deal of effort over the past few years studying the best methods for implementation of national device registries in the United States in order to enhance post-marketing surveillance of approved devices, detect early safety signals, identify poorly performing products, and improve patient mortality and success rates.

This latest effort to implement a national device registry stems from the recall of the Depuy ASR metal-on-metal hip implant. The premature failure of these hip implant devices was first noted in Australia and New Zealand. Those countries maintain national databases that track the long-term performance of medical devices in patients. The first national joint registry for hip implants was established in Sweden in 1976, and similar registries have been used in England, Germany, Finland, Slovakia, Denmark, and Canada for nearly 30 years. (...)

- FDA (legemiddelkontrollen) saksøkt for overvåkning av ansatte

FDA staffers sue agency over surveillance of personal e-mail (FDA-medarbeidere saksøker kontrollorganet for overvåkning av personlig e-post)
washingtonpost.com 30.1.2012
The Food and Drug Administration secretly monitored the personal e-mail of a group of its own scientists and doctors after they warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients, government documents show.

The surveillance — detailed in e-mails and memos unearthed by six of the scientists and doctors, who filed a lawsuit against the FDA in U.S. District Court in Washington last week — took place over two years as the plaintiffs accessed their personal Gmail accounts from government computers. (...)

Copies of the e-mails show that, starting in January 2009, the FDA intercepted communications with congressional staffers and draft versions of whistleblower complaints complete with editing notes in the margins. The agency also took electronic snapshots of the computer desktops of the FDA employees and reviewed documents they saved on the hard drives of their government computers. (...)

FDA is sued for allegedly violating privacy of employees (FDA er saksøkt for angivelig brudd på personvern for ansatte)
BMJ 2012;344:e784 (1 February)
Six current and former employees of the US Food and Drug Administration (FDA) have sued that agency for allegedly violating their right to privacy by secretly monitoring their personal email activity. The doctors and scientists reviewed medical devices for the agency as part of the approval process.

Among the monitored activity were complaints to congressional staff members about the safety and efficacy of medical devices the agency approved, over objections from the employees.

The employees say they were harassed, terminated, or did not have their contracts as outside consultants renewed because of their contacts with those staff members. They claim they are covered under the Whistleblower Protection Act of 1989 that protects federal employees who report misconduct.
The FDA Center for Devices and Radiological Health began its internal investigation into the employees over concern for the potential release of confidential information. Its request for a formal investigation by the inspector general of the Department of Health and Human Services was twice denied. The FDA has a policy of not commenting on ongoing litigation.

“Who would have thought they [FDA] would have the nerve to be monitoring my communications to Congress?” Robert C Smith, MD, JD, told the Washington Post. “How dare they?” (www.washingtonpost.com/world/national-security/fda-staffers-sue-agency-over-surveillance-of-personal-e-mail/2012/01/23/gIQAj34DbQ_story.html).

Dr Smith is one of the litigants suing the agency. The radiologist was earlier employed by Cornell University and Yale University where he was “forced out” of his position in 1999. [legal document www.ctd.uscourts.gov/Opinions/021006.PCD.Smith.pdf ]. He sued both universities. He also serves on the board of directors of the National Whistleblowers Center.

But it is not clear whether Dr Smith is correct in his assertion of privacy. US law says that employers have the right to monitor electronic communications that are conducted using property owned by the employer, such as computers and cell phones. Government computers have a standard opening screen reminding the user that they have “no reasonable expectation of privacy” on that machine.

It is alleged that the FDA investigation used “screen capture” software to record everything that the user viewed while on the job, including personal email. It did not access the hard drive of personal computers at home.

The software is the same tool the FDA used to gain information and prosecute former employees who made millions of dollars on stock trades based on insider information of the devices they were reviewing. Insider trading is illegal.

An outside expert with knowledge of the situation, who would talk only on background, said the dispute was more of a personnel issue than a policy matter. The agency needs better procedures and processes on how internal disagreements are resolved.

Last summer the Institute of Medicine recommended legal changes in the way devices are reviewed and regulated by the Food and Drug Administration. www.iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx. (...)

- For godt til å være sant

For godt til å være sant
Tidsskr Nor Legeforen 2011; 131:2228-9 (15.11.2011)
Overvurdering av effekt, manglende rapportering av komplikasjoner og finansielle transaksjoner er avdekket i det som beskrives som den største skandalen i amerikansk ryggmedisin gjennom tidene.

«Yes, isn’t it pretty to think so,» skrev Ernest Hemingway i The Sun Also Rises.

Det er grunn til å gi honnør til Eugene Carragee, professor i ryggkirurgi ved Stanford University og redaktør av Spine Journal, og hans medforfattere. I en systematisk oversiktartikkel har de kritisk vurdert sikkerhetsprofilen til det beinvekststimulerende preparatet rhBMP-2 (recombinant human bone morphogenic protein-2 (1) over tid, fra de første industrisponsede studiene til senere uavhengige vurderinger av produktet, samt ved en uavhengig gjennomgang av offentlig tilgjengelige forskningsdata. De fant en oppsiktsvekkende mangel på rapportering av komplikasjoner i 13 industrisponsede studier med i alt 780 pasienter. Mens den angitte komplikasjonsraten var 0 % i de publiserte originalstudiene, fant de ved gjennomgang av dokumenter fra FDA (United States Food and Drug Administration) en rate på 10 - 50 %.

omplikasjoner som kan oppstå ved bruk av rhBMP-2, er løsning av implantat, infeksjon, urogenitale komplikasjoner og retrograd ejakulasjon ved fremre avstivningsoperasjoner i lenderyggen; radikulitt, ektopisk beindanning, beinresorpsjon og dårligere global effekt ved bakre avstivningsoperasjoner i lenderyggen; og i tillegg luftveisobstruksjon ved avstivningsoperasjoner i nakken. (...)

Ortopeder i lommen på industrien
Tidsskr Nor Legeforen 2011; 131:2250-3 (15.11.2011)
Utviklingen av nye ortopediske produkter er avhengig av tett samarbeid mellom ortopedene og industrien. De siste årene er det imidlertid blitt avdekket en rekke tilfeller av økonomisk samrøre mellom industrien og deler av det ortopediske fagmiljø i USA. Dette har aktualisert spørsmålet om i hvilken grad ortopedirelatert forskning og utvikling kan ha vært påvirket av uheldige økonomiske incentiver.

Interessekonflikter oppstår i det øyeblikk ortopeden, eller avdelingen vedkommende arbeider i, oppnår økonomisk fordel av å promotere eller ta i bruk ett bestemt produkt. I sin mest ekstreme form kan det dreie seg om å motta godtgjørelse for konsulentoppdrag, salgsprovisjoner for et produkt man har vært med på å utvikle (royalties), aksjer eller opsjoner i firmaet. I de senere år er det blitt avdekket en rekke eksempler på slike økonomiske koblinger, først og fremst blant ortopeder i USA. Samtidig som samarbeid med industrien er av avgjørende betydning for utvikling, klinisk implementering og evaluering av ortopediske implantater, vil eventuelle interessekonflikter hos samarbeidende ortopeder kunne føre til svekket kvalitetssikring i ett eller flere ledd. Dette kan i så fall tenkes å føre til økt risiko for uheldige behandlingsutfall, også for norske pasienter operert med slikt utstyr. (...)

- Dansk firma i bestikkelsessag

Dansk firma i bestikkelsessag
business.dk 7.10.2011
BK Medical i Herlev, der producerer ultralydsudstyr til sygehuse og klinikker, mistænkes for at have bestukket sine distributører til at skaffe sig ordrer.

Det fremgår af en regnskabsmeddelelse, som BK Medicals amerikanske ejer, Analogic Corp, har udsendt, skriver DR Nyheder.

Ifølge meddelelsen er Analogic Corp i forbindelse med en regnskabsgennemgang blevet opmærksom på mulige uregelmæssigheder i det danske datterselskab, der vedrører mulig bestikkelse af distributører.

Analogic Corp oplyser videre, at et antal ansatte i BK Medical er afskediget ligesom selskabet som konsekvens af sagen har afbrudt samarbejdet med flere udenlandske distributører.

Samtidig har selskabet anmeldt sagen til både de danske og amerikanske myndigheder.

BK Medicals administrerende direktør, Jesper Lomborg Manigoff, bekræfter, at sagen eksisterer, men ønsker ikke at kommentere den overfor DR Nyheder og henviser i stedet til Analogic Corp.

Det har ikke været muligt at få en kommentar fra det amerikanske selskab. (...)

- Medisinsk tidsskrift kritiserer Medtronic voldsomt for betalinger til leger

Det amerikanske senat: Medtronic skrev tidskriftartikler
medwatch.dk 29.10.2012
Ifølge en ny rapport fra det amerikanske senat har medico-giganten være involveret i at skrive videnskabelige artikler og betalt læger for at gøre det.

Det amerikanske senats finanskomité skriver i en rapport d. 26. oktober, at Medtronic hemmeligt har forfattet artikler i medicinaltidskrifter, samt betalt millioner af dollars til læger i ”konsultationsgebyrer.”

Medtronic er et af medicoindustriens førende selskaber og verdens største producent af hjerterytmeprodukter.

Rapporten handler primært om bekymringer vedrørende Medtronics håndtering af InFuse, et redskab der bruger et genetisk fremstillet protein til at skabe knoglevækst ved operationer i rygsøjlen.

Redskabet, der blev godkendt i 2002, var en kæmpesucces for Medtronic og indbragte selskabet i omegnen af 800 mio. dollars om året. Salget er siden faldet drastisk, eftersom en række artikler i tidsskriftet The Spine Journal har dokumenteret, at InFuse øger risikoen for sterilitet, infektioner, og kræft.

Senatets rapport konkluderer, efter at have gennemgået 5000 af Medtronics dokumenter over 16 måneder, at selskabet har været ”stærkt involveret i at skrive, redigere, og udforme indholdet af artikler til medicinske tidsskrifter.” Artikler, som konstaterede, at InFuse ikke havde nogen bivirkninger.

Dokumenter udgivet af de amerikanske sundhedsmyndigheder FDA viser dog, at patienter, der deltog i testforsøg med InFuse, oplevede smerter, cyster, infektioner, samt andre komplikationer.

Rapporten konstaterer endvidere, at Medtronic betalte 210 mio. dollars til læger i perioden fra november 1996 til december 2010.

Læs resten af historien, samt Medtronics svar på anklagen, hos Medical Daily. (...)

U.S. Senate: Leading Medical Device Company Ghost-Wrote Articles, Paid Physicians (Senatet: Ledende medisinsk utstyrsfirma spøkelsesskrev artikler, betalte leger)
medicaldaily.com 25.10.2012
Medtronic spøkelsesskrev og redigerte artikler utgitt i medisinske tidsskrifter, og betalt leger millioner av dollar i "konsultasjons"-avgifter, uttalte United States Senate's Finance Committee i en rapport i dag. (Medtronic ghost-wrote and edited articles released in medical journals, and paid physicians millions of dollars in "consulting" fees, the United States Senate's Finance Committee stated in a report today.)

The United States Senate's Finance Committee released a report today, which stated that Medtronic ghost-wrote and edited articles released in medical journals, and paid physicians millions of dollars in "consulting" fees.

Medtronic is a leading company in the medical device industry, and is the world's largest maker of heart-rhythm products. The report mostly concerns Medtronic's care of the InFuse device, which uses a genetically engineered protein to create bone growth for spinal fusion surgery along with a fusion device. For a time, the InFuse device, which was approved for use in 2002, was a huge moneymaker for Medtronic, garnering the company $800 million a year. Its sales have since plunged since a series of articles written in The Spine Journal showed that InFuse elevated risk for infertility, infections, and cancer. Since then, sales of the device are a fraction of what they once were, at $141 million during the second quarter of 2011. (…)

Medical Journal Slams Medtronic Over Payments To Doctors (Medisinsk tidsskrift kritiserer Medtronic voldsomt for betalinger til leger)
blogs.forbes.com 28.6.2011
A major medical journal has taken the dramatic step of publishing a series of articles alleging that side effects were downplayed or omitted in scientific articles about a Medtronic product used in spine surgery.

Instead, authors repeatedly asserted the device, called Infuse, caused few complications, according to the report by The Spine Journal, the official publication of the North American Spine Society. Moreover, the journal says, the authors of those often had received significant amounts of money from Medtronic.

On every large study of Infuse, at least one author had received at least $10 million in royalties, consulting, or other payments from Medtronic, according to Eugene Carragee, the Spine Journal’s editor.

“I was really shocked,” says Carragee, who is also a professor at Stanford University. “I wouldn’t have thought I was very naïve about this stuff. I’ve been doing this for 25 years.” (...)

Richard Kuntz, Medtronic’s chief scientific officer, says he has found no evidence that Medtronic played a role in preparing the papers, aside from answering the questions of the outside academics. There were no ghostwriters, as has appeared to occur with other published studies. (...)

Carragee sees a need for much more disclosure of financial conflicts. Among the steps being taken: instead of disclosing payments from companies as footnotes, The Spine Journal intends to put them in the body of articles. That means that if they are incorrect, it could stand as grounds for retraction. This could also lead readers to take the payments more seriously.

“I think that if you do a service for the company and the service is worth ‘X’ amount of money you should get ‘X’ amount of money,” says Carragee. “But if you’re writing advertising copy it should be in the advertising section.” (...)

(Anm: The Spine Journal 2011 (June 28).)

Journal Blasts Industry-Funded Researchers in Spine Surgery Studies for Flawed Research, Undisclosed Financial Relationships (Tidsskrift kritiserer industrifinansierte forskere voldsomt for mangelfull forskning for ryggoperasjon-studier, og ikke å ha opplyst om økonomiske forbindelser)
JAMA 2011 (June 28)
The financial ties between clinical researchers who conducted studies on a product used in spine surgery and the manufacturer of the product have come under fire, raising questions about the integrity of this industry-sponsored research. (...)

An editorial appearing today in The Spine Journal sharply questions the objectivity of purportedly independent researchers participating in industry-funded studies of a product used in spinal fusion surgery.

The editorial is part of a special issue of the journal that focuses on a product containing synthetic bone growth factor, recombinant bone morphogenetic protein-2 (rhBMP-2), manufactured by Medtronic under the name Infuse Bone Graft. The product is intended to allow surgeons to bypass harvesting bone graft material directly from their patients.

In another section of the special issue, a review article assessed published reports of 13 original industry-sponsored studies of safety and efficacy of rhBMP-2 in 780 patients. In these studies, the researchers reported no adverse events such as unintended bone growth. But the authors of the review, using US Food and Drug Administration data summaries, follow-up publications, and administrative and organizational databases analyses, estimate that between 10% to 50% of patients should have experienced an adverse event, including life-threatening events. The authors also said that as of March 2011, Medtronic had paid the clinical investigators of the 13 studies amounts ranging from $560 000 to $23.5 million per study. (...)

In the editorial, the editor of The Spine Journal, Eugene J. Carragee, MD, of the Stanford University School of Medicine and colleagues wrote that the “choirboy defense”—the belief that theirs is an honest profession with unimpeachable integrity and the highest ethical standards—can no long apply to researchers in the spine community. “It harms patients to have biased and corrupted research published,” they wrote. “It harms patients to have unaccountable special interests permeate medical research. It harms patients when poor publication practices become business as usual.” (...)

Medtronic Surgeons Held Back, Study Says (Medtronic: Kirurger hemmeligholdt informasjon, ifølge studie)
online.wsj.com 29.6.2011
Surgeons who conducted clinical trials to test a Medtronic Inc. bone-growth protein widely used in spine surgery didn't report serious complications that arose in those trials in their research papers, a new study says.

Over the past decade, 15 of those surgeons have collectively received at least $62 million from the medical-device giant for unrelated work, according to a Wall Street Journal analysis of Medtronic documents and of recent disclosures made on the company's website.

Last week, the Senate Finance Committee began investigating whether Medtronic's large payments to the surgeons played a role in the fact they didn't report the ... (...)

Surgeons in Medtronic trials omitted results: report (Kiruger i Meditronic-forsøk utelot resutater, ifølge rapport)
reuters.com 28.6.2011
(Reuters) - Surgeons conducting clinical trials to test a Medtronic Inc bone-growth protein used in spine surgery, some of whom got at least $62 million from the company, failed to report serious complications in their research papers, the Wall Street Journal reported.

Fifteen of the surgeons got at least $62 million from the company over the past decade, the paper said, citing an analysis of Medtronic documents and disclosures on the company's website.

A new study in the Spine Journal said serious complications including cancer, sterility, infections, bone dissolution and worsened back and leg pain, occurred in 10 to 50 percent of patients who were administered Infuse or a sister product in 13 clinical trials funded by Medtronic and conducted by the surgeons between 2000 and 2010, the Wall Street Journal said. (...)

- For dårlig overvåkning av medisinsk utstyr

FDA needs better recall monitoring, says GAO (FDA trenger bedre overvåkning av tilbaketrekking, ifølge GAO)
in.reuters.com 23.6.2011
(Reuters) - Congressional auditors have faulted U.S. health regulators for failing to track unsafe medical devices after they are recalled, opening the door to further risks to patients.

The Government Accountability Office (GAO) found 21 high-risk recalls between 2005 and 2009 where companies were unable to correct or remove faulty devices. Its report, dated June 14, was released to the public on Wednesday.

"The FDA can't tell if recalls of high-risk devices were carried out successfully because it lacks criteria for assessing device recalls and doesn't routinely review recall data," said Senator Charles Grassley in a statement, referring to the U.S. Food and Drug Administration.

"It looks like the FDA is missing an opportunity to proactively identify and address risks presented by unsafe devices," he said.

High profile recalls include last year's massive recall of artificial hips from Johnson & Johnson's DePuy unit. Some 93,000 patients worldwide had that line of hip implant.

Medtronic had to recall heart defibrillator leads several years ago, while the FDA recently expanded a recall of coronary imaging catheters from Boston Scientific Corp.

The FDA has already issued seven high-risk device recalls this month. The agency said on Wednesday it had taken steps to improve the recall process with a program launched last November. (...)

(Anm: Medical Devices: FDA Should Enhance Its Oversight of Recalls. GAO-11-468 June 14, 2011 (pdf).)

Lobbynettverket

As Congress Goes on Break, Health Lobbying Heats Up
online.wsj.com 6.8.2009
Medical-device makers are adamant that U.S. health care needs fixing. They're equally adamant that they shouldn't have to pay for it.

"If you're looking for savings, don't come at us," says Tim Trysla, a top industry representative. He has marched into the offices of 120 lawmakers, sometimes with General Electric Co. officials in tow, to argue that the government already provides so little reimbursement for high-tech medical scans that it shouldn't chop payments further.

Groups of all stripes are blitzing lawmakers to shape a trillion-dollar health-care overhaul that would reach into every business and every home in the country. In the lobbying frenzy, many longtime allies are divided, often pitting hospital against hospital, retailer against retailer and doctor against doctor. And, not surprisingly, the fault lines emerge where the bills' provisions would cost them money.

With the legislation now held up until after Congress's August recess, interest groups are treating the next few weeks as a critical time for rank-and-file members to try to snare one-on-one meetings with lawmakers back in their home districts. (...)

The Lobbying Web (Lobbynettverket)
nytimes.com 1.8.2009
PRESIDENT OBAMA entered the White House challenging Washington’s political culture and promising a retooled health care system. Now the persistence of the former threatens his ability to deliver the latter.

Mr. Obama’s jampacked domestic agenda, from new rules for Wall Street to limits on carbon emissions, has set off a full-scale lobbying brawl involving the “narrow interests” he derided in his Inaugural Address. The health care fight represents the biggest brawl of all.

The $133 million in lobbying expenditures by health industry interests in the second quarter of 2009 alone — the most of any sector by far, according to the Center for Responsive Politics — hardly sounds like the change Mr. Obama or his supporters had in mind. And in fact the strategic course the White House has chosen may have had the unintended effect of increasing the breadth and complexity of the battle involving those interests. (...)

Lobbyists battle over drug sales (Lobbyister kjemper om legemiddelsalg)
usatoday.com 28.7.2009
WASHINGTON — As Congress struggles with a massive health care overhaul, several lobbying powerhouses — including the pharmaceutical industry and the nation's largest advocacy group for retirees — are locked in a contentious fight over the future of biotechnology drugs.

Both sides have spent heavily to sway lawmakers in the debate over how long to keep the expensive drugs exempt from generic competition. President Obama is pushing for seven years of exclusivity as he looks to trim costs to help pay for his health care plan — five years less than what the industry wants. (...)

- Leverandører for LFH en viktig alliansepartner for Legemiddelindustrien

Leverandører for LFH en viktig alliansepartner for Legemiddelindustrien
lfh.no (9.11.2010)
Karita Bekkemellem holdt innlegg på LFHs ekstraordinære generalforsamling 26.oktober.

LFH er en viktig samarbeidspartner og vi kan lage en felles møteplass med myndighetene, sa Karita Bekkemellem på møtet. LFH har i høst underskrevet samarbeidsavtaler med de regionale helseforetakene, og LMI har hatt gleden av å være med på disse møtene. Det er viktig at vi nå står sammen om å påse at lederne i helseforetakene informerer og følger avtalene, sa Bekkemellem. Vi har nå samarbeidsavtaler som regulerer samhandlingen, og vi må nå sørge for at det blir samhandling og samarbeid som kommer pasientene tilgode, og som også fremmer forskning og næringsutvikling i Norge, sa Bekkemellem.

Bekkemellem slo fast at innsatsen fra kommersielle leverandører er for lite verdsatt i helsepolitikken, og at det må være et mål for oss å sitte ved myndighetenes bord der avgjørelsene blir tatt. Våre produkter står til sammen bare for 8 prosent av utgiftene ved helseforetakene, men vi kan effektivisere helsetjenesten dersom våre produkter raskt blir tatt i bruk, sa Bekkemellem. (...)

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

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

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

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

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

- Amerikanske medisinske skoler bryter fremdeles regler for interessekonflikter, ifølge rapport

US medical school faculty still break conflict of interest rules, report says (Amerikanske medisinske skoler bryter fremdeles regler for interessekonflikter, ifølge rapport)
BMJ 2010; 341:c7435 (30 December)
ProPublica, an independent, non-profit investigative journalism project, reported that although medical schools have strengthened their rules about faculty members’ interactions with drug companies, some doctors still break their institutions’ conflict of interest rules.

The report is part of ProPublica’s Dollars for Docs project, which it launched in October 2010 (BMJ 2010;341:c6026; doi:10.1136/bmj.c6026).

The recent report said that some medical schools with tough conflict of interest policies were not checking to make sure faculty members followed the rules. It pointed to Stanford University, among others, saying that faculty members had not disclosed ties to drug and device companies. (...)

- Medicogiant frygter Google. (- Vi bruger 1,5 mia. dollar på forskning og udvikling i Medtronic – og størstedelen af dem på udvikling. Google bruger 8 mia. dollar om året på forskning og udvikling.)

Medicogiant frygter Google
medwatch.dk 12.5.2014
Verdens største medicoselskab Medtronic mener, at den største trussel til selskabets markedsdominans vil komme fra teknologigiganten Google i den nærmeste fremtid.

Den amerikanske storkoncern Medtronic er verdens største aktør udelukkende med fokus på medicomarkedet. En række rivaler står dog på spring for at kapre markedsandele på det lukrative marked, mens spørger man selskabets direktør for medicinsk teknologi, kommer den største trussel til selskabets dominans fra en noget uventet kant.

”Vores ærkerival om 20 år vil ikke være Boston Scientific eller St. Jude Medical eller Covidien eller HeartWare. Det vil være Google. Det er jeg helt sikker på,” udtaler Dr. Stephen Oesterle, vice president, medicine & technology, ifølge mediet massdevice.com.

Selvom Medtronic indtager førstepladsen på markedet for medicinsk udstyr og bruger store summer på forskning og udvikling, så kan koncernen langt fra hamle op med teknologigiganten.

”Vi bruger 1,5 mia. dollar på forskning og udvikling i Medtronic – og størstedelen af dem på udvikling. Google bruger 8 mia. dollar om året på forskning og udvikling, og, så vidt jeg kan se, bruger de størstedelen af dem på forskning,” tilføjer direktøren.

Google har på det seneste bevæget sig ind på flere dele af sundhedsområdet, bl.a. gennem oprettelsen af biotekselskabet Calico, der har som erklæret mål at forlænge menneskers liv, samt med de meget omtalte smart glasses, der meget vel kan blive standardudstyr på hospitaler og sygehuse verden over indenfor en overskuelig årrække. (...)

(Anm: Søk, søkemotorer, søkeord, annonsering, internett etc. (mintankesmie.no).)

- Et av de siste fremstøtene fra Google og morselskapet Alphabet går sammen med legemiddelgigant GlaxoSmithKline og satser seks milliarder kroner på bioelektronikk.

Nå vil Google kurere sykdom med elektriske impulser som overstyrer kroppen
e24.no 3.8.2016
Et av de siste fremstøtene fra Google og morselskapet Alphabet går sammen med legemiddelgigant GlaxoSmithKline og satser seks milliarder kroner på bioelektronikk.

Verily, et av selskapene under Google og Alphabet, trår nå inn i et av de mest nytenkende feltene innen medisin, og satser 6 milliarder kroner i et joint venture med legemiddelgiganten GlaxoSmithKline.

Satsningen får navnet Galvani Bioelectronics, og skal forske på et eksperimentelt felt innen medisin/teknologi der biologi og elektronikk fusjoneres.

Verily ligger under Alphabet og Googles såkalte X-arm, der diverse teknologiselskaper blant annet satser på roboter, selvkjørende biler, droner og internett-tilgang for å nevne noe.

Galvani Bioelectronics skal eies 55 prosent av GSK og 45 prosent av Verily/Alphabet/Google, ifølge Recode.

Det medisinske feltet av bioelektronikken går kort fortalt ut på at forskerne kartlegger de elektriske impulsene som styrer mekanismer og funksjoner i menneskekroppen - og hvordan man kan overstyre disse når det går galt og kroppen blir syk.

Financial Times skrev mer om feltet i mars, les artikkelen her. (…)

(Anm: UPDATED: Google’s Verily and GlaxoSmithKline hatch a $713M plan to spark a biorevolution. Global pharma giant GlaxoSmithKline is teaming up with Google’s life sciences venture Verily, channeling its four-year effort to create new nanotech-based bioelectronic therapeutics into a startup called Galvani Bioelectronics, with joint plans to invest $713 million into the venture over the next 7 years. (endpts.com 1.8.2016).)

(Anm: Scientists aim to harness power of body’s electrical impulses to treat patients. (…) High quality global journalism requires investment. Until now the pharmaceutical industry has been based on chemistry and biology. Patients are treated with drugs that work through biochemical interactions with the body’s molecular pathways. Now GlaxoSmithKline, the UK pharmaceutical company, is pioneering a different approach: so-called bioelectronics, or electroceuticals. These aim to turn our electrical impulses into a mainstay of medical treatment. (ft.com 2.3.2016).)

(Anm: Kai A. Olsen, professor i informatikk, Høgskolen i Molde og Universitetet i Bergen. Lettvint om selvkjørende biler. Det som bør bekymre teknologi­entusiastene er hvorfor vi ikke allerede har selvkjørende biler på veiene. Veidirektør Terje Moe Gustavsen tror ikke det er så veldig lenge til det blir ulovlig for mennesker å holde i rattet. NAFs kommunikasjonssjef Inger Elisabeth Sagedal går så langt som å gi et årstall for når de selvkjørende bilene overtar. Ifølge henne vil vi være der i 2030. (dn.no 26.7.2017).)

Google-stifter finansierer medicinalfirmaers forskning

Google-stifter finansierer medicinalfirmaers forskning
medwatch.dk 11.5.2012
Sergey Brin, der har opbygget en enorm formue gennem Google, kaster af personlige årsager betydelige summer ind i GSK og Pfizers forskning i Parkinsonslægemidler.

Den ene af de to Google-stiftere, Sergey Brin, opdagede i 2008, at han har et gen, der prædisponerer ham for Parkinsons. Et gen, som han deler med sin mor, der allerede har udvklet sygdommen.

Dette fik ifølge Bloomberg den hovedrige IT-entreprenør (han har en anslået formue på 19 mia. dollar) til øge donationerne til forskningen på området.
Indtil videre har han doneret 132 mio. dollar, hovedsageligt til Michael J. Fox Foundation for Parkinson’s Research. Og en del af pengene er gået direkte til GSK og Pfizers udvikling af lægemidler.

I 2009 donerede Brin 15 millioner dollar, der er møntet på udviklingen af såkaldt LRRK2-medicin, og han har været hovedsponsor på Fox Fondens LRRK2-indsats siden. (...)

Alastair Reith, der er GSK's forskningsleder på projektet, mener ikke, at arbejdet med lægemidlerne havde været muligt uden donationen, for hjernesygdomme er ifølge lederen ikke højt på prioritetslisten hos medicinalfirmaerne. (...)

Diverse artikler

J&J ramt af milliarddyr dom i hoftesag.
medwatch.dk 18.3.2016
Fem sagsøgere har i Texas fået tildelt en milliardstor erstatning fra Johnson & Johnsons datterselskab DePuy i sagen om hofteimplantater, hvor omkring 8000 flere sagsøgere venter, alene i Texas.

500 mio. dollars, eller hvad der svarer til 3,3 mia. kr. Så meget er fem sagsøgere ifølge Reuters blevet tildelt af en jury ved en domstol i Texas.

De fem havde sagsøgt Johnson & Johnson-datterselskabet DePuy i en retssag, hvor selskabets metal-mod-metal-hofteimplantat Pinnacle beskyldes for at være defekt og forårsage metalaffald i patienternes blod. Udfaldet blev, at juryen fandt, at Pinnacle-hofterne var mangelfuldt designet, og at selskaberne ikke advarede offentligheden om deres risici.

Domme i disse tidlige retssager er ikke bindende for resten af retssagerne, der fortsat venter for J&J, men bruges til at hjælpe med at vurdere værdien af de resterende krav. Mere end 8000 Pinnacle-relaterede retssager er blevet konsolideret ved Texas' føderal domstol. J&J vil dog appellere dommen og forventer, at erstatningen ved appeldomstolen kan blive reduceret til så lidt som 10 mio. dollars. (…)

DePuy stoppede med at sælge metal-mod-metal-versionen af Pinnacle i 2013. I øvrigt samme år, som man betalte 2,5 mia. dollars i forlig for at afslutte mere end 7000 retssager vedrørende en anden metal-mod-metal-hofte, ASR, som blev tilbagekaldt i 2010. (…)

Norske kirurger planla å operere med pirat-skalpeller – kan være svært farlig.
tv2nyhetene.no 18.6.2015
De ulovlige instrumentene skulle brukes av en legeklinikk på Østlandet.

– Dette er første gangen vi ser ulovlige kirurgiske instrumenter bli beslaglagt, og det er svært alvorlig, sier seniorrådgiver i Helsedirektoratet, Ingeborg Hagerup-Jensen til TV 2.

Det medisinske utstyret kom med flyfrakt til Gardermoen denne uken. Avsenderen er fra Pakistan og utstyret er bestilt av en privat legeklinikk på Østlandet. (…)

Potentielt livsfarlige MR-scannere i Danmark
medwatch.dk 25.2.2015
Tusindvis af MR-scannere fra GE Healthcare er blevet klassificeret som potentielt livsfarlige af FDA. Flere scannere er distribueret til Danmark. (…)

Studie: Kompressionsstrumpor har ingen effekt
dagensmedicin.se 7.3.2014
Patienter som lottats till att använda kompressionsstrumpor efter en djup ventrombos fick inte minskad risk för bestående svullnad och smärta från benet, enligt en studie i Lancet.

– Det här är en mycket välgjord undersökning. Men det finns en del frågetecken. Och resultaten behöver upprepas i en annan studie innan man eventuellt skulle avskaffa den här behandlingen, säger Lennart Stigendal, överläkare vid koagulationscentrum på Sahlgrenska universitetssjukhuset i Göteborg. (...)

Efter två års uppföljning fanns det ingen skillnad mellan grupperna i andelen deltagare som drabbats av posttrombotiskt syndrom, det vill säga smärta, bensvullnad och ibland bensår på grund av skadade klaffar i benens blodkärl.

Enligt forskarna var resultatet detsamma när olika undergrupper av deltagarna analyserades, till exempel bland flitiga användare som använt strumporna mer än tre dagar per vecka.

Studien är den hittills största på området och resultaten skiljer sig från andra mindre studier, där man sett större effekt av kompressionsstrumpor. Enligt forskarna ifrågasätter deras resultat användningen av kompressionsstrumpor som rutinåtgärd efter djup ventrombos. (...)

(Anm: Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial. Lancet 2014; 383: 880–888.)

Knap 1.000 sagsøger Medtronic
medwatch.dk 6.3.2014
Den amerikanske medicogigant Medtronic bliver trukket i retten af knap 1.000 utilfredse amerikanere, og ligeså mange kan stå klar i kulissen.

Omkring 1.000 amerikanere har sagsøgt medicokoncernen Medtronic pga. selskabets knoglevækst-produkt, Infuse - og ligeså mange sager kan være på vej. Det fremgår af en artikel fra det amerikanske nyhedssite twincities.com.

Herudover undersøger en række stater selskabets salg og markedsføring af produktet, som bruges i forbindelse med rygradskirurgi.

Infuse, der også går under navnet BMP-2, indeholder et biologisk stof som stimulerer knoglevæksten i rygraden. Produktet er implanteret i mere end 1 million mennesker. Men i de fleste af disse tilfælde er produktet blevet brugt i indikationer, det ikke er godkendt mod – såkaldt off-label brug. Ifølge mediet gør det sig gældende i op til 85 pct. af sagerne.

”Når du bruger et produkt off-label i 85 pct. af tilfældene, så løber du ind i problemer,” siger den ortopædiske kirurg Dan Spengler til twincities.com.
Da salget af Infuse toppede, solgte det for 800 mio. dollar årligt. Men siden 2011 er salget faldet markant.

(Anm: Nearly 1,000 sue Medtronic over Infuse bone growth product (twincities.com 4.3.2014).)

New and unproved medical devices
Editorial
BMJ 2013;347:f7413 (19 December 2013)
Enthusiasts need educating about the clinical, ethical, and legal implications of choices supported by limited data

There is a well established nomenclature for describing the uptake of new technologies.1 “Innovators” adopt a novel approach the fastest; they are often mavericks and have personalities that feature a high tolerance for risk. “Early adopters” are the next to take up the new technology. Their behavior, which is only slightly more circumspect, has been described as self conscious experimentation.2 Together, these professionals are one standard deviation greater than average in terms of speed of adoption than their peers and make up about 16% of the relevant population.2 (...)

Medicoindustrien frygter dyre EU-regler
medwatch.dk 25.9.2013
Medico & Rehab: Den danske og europæiske brancheforening for medicofirmaer er bekymrede for, at de nye og strammere EU-regler for godkendelse af medicinsk udstyr, vil give dyre forsinkelser. Ren lobbysnak, mener EU-politiker.

I kølvandet på en række implantat-skandaler vil man stramme reglerne for godkendelse af medicinsk udstyr. Et nyt udkast til regelsættet er på vej til afstemning i EU-parlamentet, men som de ser ud nu, er den danske brancheforening Medicoindustrien ikke tilfreds, skriver dagbladet Børsen.

"Vi er meget i tvivl om, at det, som foreligger, nu også er til fordel for patientsikkerheden. Og det, vi med sikkerhed ved, er, at det vil gøre processen langt mere tidskrævende og dyrere," siger vicedirektør i Medicoindustrien Lene Lauersen til avisen. (...)

Varsler medisinsk-teknisk katastrofe i diabetesomsorgen
dagensmedisin.no 25.9.2013
Vil REGULERE: EASD-president Andrew Boulton og BMJs Deborah Cohen ønsker regulering av medisinskteknisk utstyr i EU.

Presidenten for den europeiske diabetesforeningen varsler en katastrofe innen diabetesomsorgen dersom EU ikke overvåker dette markedet strengere.

BARCELONA: Andrew Boulton, presidenten i den Europeiske diabetesforeningen EASD, fortalte på en pressekonferanse onsdag at stadig flere rapporter dreier seg om manglende regulering og overvåking av medisinskteknisk utstyr, også innenfor diabetesområdet.

Feil på insulinpumper
– En studie viste at av 640 insulinpumper som ble sjekket mellom 2001 og 2007, var det feil med 36 prosent av pumpene. 16 av dem sviktet fullstendig. Studier fra USA viser lignende tall om insulinpumper, og her var det flere dødsfall som følge av feilene, sa Bolton.

EASD har lenge lobbet for et forslag om å innføre et eget byrå som skal overvåke og regulere dette markedet.

Vil følge norsk eksempel
De krever at EU nå følger Skandinavias standarder for regulering av medisinsk utstyr:

Norge, Sverige og Danmark har det såkalte The Scandinavian Evaluation of Laboratory Equipment for Primary Care, som gjennomfører tester av utstyr for blant annet å sikre at det fungerer sikkert. (...)

Registreringspligt for medicinsk udstyr indføres
medwatch.dk 7.8.2013
MEDICO & REHAB: Som en del af patient-sikkerhedspakken fra regeringen træder en registreringspligt snart i kraft for danske importører og distributører af medicinsk udstyr hos Sundhedsstyrelsen. Medicoindustrien bakker op om tiltaget. (...)

Medtronic kædet til dødsfald
medwatch.dk 3.7.2013
Medicogiganten Medtronic har udsendt advarsler om et af selskabets produkter, som er blevet kædet sammen med 14 dødsfald.

Amerikanske Medtronic har udsendt fire advarsler om sit produkt SyncroMed Implantable Infusion System, efter produktet er blevet kædet sammen med 14 dødsfald. Det skriver hjemmesiden qmed.com.

Udstyret er til såkaldt intratekal levering af medicin for patienter med smerter og spasmer af spinal eller cerebral oprindelse, oplyser Medtronic ifølge hjemmesiden i en pressemeddelelse. Det vil sige, at medicinen leveres direkte i patientens krop i flydende form via et kateter hjulpet af en pumpe.

Men en fejl i denne del af udstyret kan føre til utilsigtet levering af medicinen, hvilket kan resultere i over- eller underdosering af lægemidlet. (...)

Prevalence and nature of adverse medical device events in hospitalized children
J Hosp Med. 2013 Jun 7. doi: 10.1002/jhm.2058. [Epub ahead of print]
Abstract Our objective was to describe the prevalence and nature of adverse medical device events (AMDEs) in tertiary care children's hospitals. In our retrospective cohort study of patients at 44 children's hospitals in the Pediatric Health Information System (PHIS), we included all inpatient stays with an AMDE-related diagnosis from January 1, 2004 to December 31, 2011. We identified AMDEs by diagnoses that specified a device in their definition. We included events present on admission as well as those complicating hospital stays. We described the characteristics of these admissions and patients, and stratified analysis by device category and presence of a complex chronic condition. Of 4,115,755 admissions in the PHIS database during the study period, 136,465 (3.3%) had at least 1 AMDE. Vascular access and nervous system devices together represented 44.4% of pediatric AMDE admissions. The majority (75.5%) of AMDE admissions were of children with complex chronic conditions. The most common age group was patients aged 2 years or less at the time of their first AMDE-related admission. AMDEs occur commonly in a population cared for in tertiary children's hospitals. Research to more specifically delineate AMDEs and their predictors are next steps to understand and improve device safety in children. Journal of Hospital Medicine 2013. © 2013 Society of Hospital Medicine. (...)

FDA warns of risk of cyberattacks on medical equipment, hospital networks
modernhealthcare.com 14.6.2013
The Food and Drug Administration issued a notice on Thursday asking medical device manufacturers and healthcare facilities to introduce controls that would guard against cyberattacks on medical equipment and hospital networks.

Because many medical devices connect to the Internet, they are at risk of being infected with computer viruses that can affect the way they operate, putting patients' health in jeopardy. And devices and networks that are not properly secured leave them and the data they contain vulnerable to unauthorized access and use. (...)

The FDA is recommending that manufacturers implement security controls such as user authentication, stronger passwords, physical locks and card readers. Other suggestions include security patches and restrictions on updates to authenticated code, as well as design approaches that maintain a device's critical functionality even in the event of an attack or breach. (...)

Trials are needed before new devices are used in routine practice in Europe
BMJ 2013;346:f1646 (Published 18 March 2013)
As the EU debates new legislation to regulate medical devices, Philipp Storz-Pfennig, Mechtild Schmedders, and Matthias Dettloff provide examples from Germany to show why the current proposals do not go far enough and call for further assessment after market approval

A growing number of examples, including metal on metal hip implants and breast implants, show the harm that can result from new devices and procedures being introduced without a rigorous assessment of their safety and efficacy.1 2 3 4 5 6 7 This has led to the wide acceptance that the system for regulating medical devices, particularly in the European Union (EU) is flawed. The European parliament is currently debating proposals put forward last year by the European Commission to reform the EU legislation for medical devices and in vitro diagnostics.8 9

However, the new proposals will not change market access to new devices appreciably.10 Notified bodies will continue to grant market approval (through CE certificates), although quality assurance will be stepped up—the European Commission will have to set up a medical devices coordination group to supervise notified bodies and advise on their assessments of new high risk devices and diagnostic tests, and there will be harmonised criteria for accreditation. After a device is approved, there will also be stronger postmarketing surveillance. The proposals include the introduction of a “unique device identifier” and unheralded inspections of device manufacturers by notified bodies. (...)

Companies Dig Into Sunshine Rule Details In Preparation For Aug. 1 Go-Live Date
elsevierbi.com 14.2.2013
Executive Summary
CMS has finalized several sunshine rule provisions: the definition of “applicable manufacturer” has been narrowed; many payments to speakers at continuing medical education programs and events need not be reported; and the agency will allow manufacturers to supply contextual information on the public database. (...)

Analysis: When implanted medical devices go wrong, who pays? (Analyse: Når det går galt med implantert medisinsk utstyr, hvem betaler?)
reuters.com 8.10.2012
(Reuters) - Insurance companies, often stuck with the tab for health services when a medical device fails, are ready to share the pain.

As the number of costly, high-profile recalls rises, along with pressure to cut their own spending, insurers are starting to pin more of the responsibility on manufacturers.

If they succeed, medical device makers - already worried about weaker global demand for many of their products and the impact of a new U.S. tax on their profits - will have even more costs in the wake of product recalls, the biggest of which can already lead to billions of dollars in expenses.

"The (insurance) plans are being more aggressive. The reason it gets so much more focus now is because there are so many cases," said Mark Fischer, chairman of Rawlings & Associates, a unit of the Rawlings Group that helps insurance companies recoup payments from the party that was deemed at fault for claims, a legal service known as subrogation.

In recent years, more than a hundred medical devices were recalled out of concern they could cause serious injury or death. (...)

J&J Said to Pay $600,000 to Settle First Suits Over Hips (J&J sies å ha betalt 600 000 dollar for å forlike første hofte-søksmål)
bloomberg.com 22.8.2012
Johnson & Johnson (JNJ), which faces about 8,000 lawsuits over hip implants it recalled in 2010, agreed to pay about $600,000 to resolve three cases in the first settlements of the litigation, people familiar with the accords said.

Officials of J&J’s DePuy unit agreed earlier this month to settle Nevada residents’ suits over the company’s ASR hip implants, two people familiar with the agreement said. The company will pay about $200,000 a case to resolve the suits before they were scheduled to go to trial later this year, the people said. They spoke on condition of anonymity because they weren’t authorized to speak publicly about the accords. (...)

Professor advarer mod ny sundhedsskandale i Boneloc-klassen
politiken.dk 19.8.2012
Mange hundrede danske kvinder med nedsunket underliv har fået indopereret et potentielt dødeligt aggregat, siger gynækolog.

En skandale af mindst samme omfang som Boneloc-sagen kan være undervejs i det danske sundhedsvæsen.

Professor i gynækologi på Herlev Sygehus Gunnar Lose advarer mod syntetiske 'net', som mange hundrede danske kvinder med nedsunket underliv har fået indopereret. De skal typisk afhjælpe fødselsskader ved at sikre, at livmor og blære ikke falder ud af skeden.

I Ugeskrift for Læger kalder han metoden for »en tikkende bombe«, fordi komplikationerne ved nettene, såkaldte mesh-implantater, kan være yderst alvorlige - i enkelte tilfælde dødelige. Alligevel undlader lægerne at orientere patienterne om risikoen.

»Internationale opgørelser viser, at hos 10 procent skærer nettet sig igennem til skeden, og 10 procent får smerter ved samleje. Det er mange«, siger Gunnar Lose til Ritzau.

»I sjældne tilfælde opstår der hul til tarmen eller urinvejene. Sker det, kan det ende med, at kvinden dør«, siger han. (...)

Patienternes sikkerhed er i fare
Når Gunnar Lose frygter, at der forude venter en skandale af samme omfang som Boneloc- og senest DePuy-hofteproteserne, skyldes det, at nettene, ligesom hofteproteserne, frit kan markedsføres.

Producenten skal blot godtgøre, at de ligner noget, der allerede er på markedet.

»Når medicinsk udstyr kan komme på markedet, uden at der foreligger kliniske data, kræver det en ekstraordinær overvågning både fra lægerne og myndighedernes side. Den overvågning har vi ikke, og derfor er patienternes sikkerhed i fare«, siger Gunnar Lose. (...)

Gir ubrukelige gaver til helsevesenet i fattige land
abcnyheter.no 3.8.2012
Mye medisinsk utstyr som er utviklet for bruk i rike land, blir ubrukelig når det gis til fattige land. 40 prosent av det medisinske utstyret i utviklingsland står ubrukt, viser en fersk rapport.

Et gambisk sykehus mottok utstyr til oksygenbehandling, men maskinene krevde en annen elektrisk spenning enn det de fikk av strømleverandøren. Et sykehus i Nicaragua fikk lamper til operasjonsstua, men hadde ikke råd til lyspærer.

Det er bare noen av eksemplene på feilslått medisinsk bistand i en rapport som tidsskriftet Lancet har laget sammen med forskere ved Imperial College London.

Mye medisinsk utstyr som er utviklet for bruk i rike land, blir ubrukelig når det gis til fattige land. 40 prosent av det medisinske utstyret i utviklingsland står ubrukt, viser en fersk rapport. (...)

Produktfeil gjorde at sykehusutstyr ikke ble vasket
aftenposten.no 20.7.2012
Olympus er ansvarlige for produksjonsfeilen på vaskemaskinen ved et sykehus i Danmark. Norske sykehus har samme leverandør.

En feil ved en vaskemaskin på Slagelse Sygehus i Danmark kan ha ført til at over 700 pasienter er blitt smittet med HIV-virus eller leverbetennelse. Det bekrefter sykehuset overfor Aftenposten.no.

- Alle pasienter er blitt undersøkt bakterielt, og ingen har hatt infeksjon. Men vi har ennå ikke fått kontrollert for om de har virusinfeksjon, sier ledende oversykepleier ved kirurgisk avdeling ved Slagelse sykeshus Dorthe Denta. (...)

(Anm: Hygiene (smittsomme sykdommer / infeksjoner / smittevern) (mintankesmie.no).)

Dansk sykehus opererte 719 pasienter med skittent utstyr
aftenposten.no 19.7.2012
En teknisk feil betyr at smitte kan ha blitt videreført fra pasient til pasient.

En feil i en spesiell vaskemaskin på Slagelse Sygehus i Danmark, kan i verste fall ha ført til at over 700 pasienter kan ha blitt smittet med HIV-virus eller leverbetennelse ifølge DR Sjælland.

Feilen innebærer at kikkerter som lå i vaskemaskinen, og som brukes ved mage og tarm-operasjoner ikke ble spylt ordentlig. Dermed kan det ha blitt videreført smitte fra pasient til pasient i løpet av de ni månedene hvor spylefunksjonen i vaskemaskinen har vært i stykker.

- Da feilen ble oppdaget, ble spyleren straks skiftet ut, sier spesialansvarlig overlege Ole Bendtsen på Kirurgisk avdeling på Slagelse Sygehus.

- Alle vil nå bli tilbudt en undersøkelse for å se om de er blitt smittet. Han understreker, at smitterisikoen er veldig liten.

Hendelsen er rapportert til avdelingslederne på sykehuset, og det er disse som har bedt om at det blir gitt skriftlig beskjed til alle de 719 pasientene som har hatt kikkertene inne i kroppen under operasjon. (...)

Krever svar om Trond Mohns sykehusgaver
dagbladet.no 15.5.2012
Når milliardær Trond Mohn donerer medisinsk utstyr til Sykehus-Norge, havner bestillingene hos Siemens. Nå har en hemmelig konkurrent satt advokat på saken.

(Dagbladet): - Er de vel bevarte disse juristene? Jeg synes de burde skamme seg.

Det sier den gavmilde bergenseren og næringslivslederen Trond Mohn til Dagbladet.

Utbruddet skyldes et brev fra advokatfirmaet Steenstrup Stordrange til Helse Midt-Norge-sjef Gunnar Bovim, med kopi til Helse- og omsorgsdepartementet.

Advokatfirmaet representerer en ikke-navngitt Siemens-konkurrent som tilsynelatende har sett seg lei på at PET CT- og MR-skannere milliardæren stadig donerer til Sykehus-Norge, alle er merket med tyske Siemens.

Gavene «har resultert i innkjøp av maskiner fra Siemens, uten at vi er kjent med at disse anskaffelsene var gjenstand for forutgående anbudskonkurranser», heter det i brevet. (...)

Evaluating Sex Differences in Medical Device Clinical Trials
JAMA 2012 (Published online February 29)
Time for Action

The safety and effectiveness of medical treatments can differ in men and women for many reasons related to different epidemiologic characteristics, physiology, and body size. In general, women have higher bleeding rates and procedural morbidity and mortality than men, which means that their risk/benefit ratios for many implanted medical devices can differ from men. Therefore, sex-specific safety and effectiveness data are necessary for informed patient decision making. In 2008, the US Food and Drug Administration (FDA) convened 2 workshops on this topic that included multiple stakeholders—patient groups, medical device industry representatives, academia, and government officials. In December 2011, the FDA released a draft guidance informed by these workshops, entitled “Evaluation of Sex Differences in Medical Device Clinical Studies.”1​ This document discusses the underrepresentation of women in medical device clinical trials and provides recommendations for increasing enrollment of women and performing sex-specific analyses. A 90-day public comment period began on December 19, 2011. (...)

Medico-direktør: Vi tvinges til at betale lægers rejser
medwatch.dk 8.2.2012
Medicoindustrien har intet problem med mere åbenhed om samarbejdet med læger. Foreningen ønsker samtidig et opgør med de såkaldte uddannelsesrejser, som industrien tvinges til at betale i forbindelse med udbud.

Den danske medicoindustri er helt indstillet på at skabe mere åbenhed og strammere regler for samarbejdet mellem industrien og de læger, der bruger medicoudstyr eller indopererer eksempelvis hofter.

Det fortæller direktør i brancheforeningen Medicoindustrien, Peter Huntley.

"Vi har principielt ingen problemer med at der skal være den samme åbenhed og gennemsigtighed i samarbejdet mellem læger og lægemiddelindustrivirksomheder og mellem læger og medicovirksomheder. Det er ikke noget, der er problematisk for os, men som det er nu, hviler de to industrier på to forskellige lovgivninger, og derfor skal vi selvfølgelig finde ud af, hvorfra og hvortil reglerne skal gå," siger Peter Huntley.

Kravene om mere åbenhed er fremsat af flere politikere og patientforeninger, efter det er kommet frem, at Protesekompagniet, der forhandlede de farlige franske hofter, ASR, har sponsoreret ortopædkirurgisk selskab, som er en forening af danske ortopædkirurger.

Protesekompagniet har ikke ønsket at udtale sig, men henviser i stedet til Peter Huntley. (...)

Regler må ikke hæmme vidensdeling
Selvom Medicoindustrien ikke ser noget problematisk i en øget åbenhed om sponsering og samarbejder, så advarer Peter Huntley dog imod helt at forbyde industrien at samarbejde med lægerne.

"Vi skal passe på, at reglerne ikke bliver så skrappe, at virksomhederne ikke har mulighed for at bidrage, når der holdes konferencer eller annoncere på lægernes hjemmeside, for så bliver det svært at udveksle erfaringer og viden. Men hvis man vil have regler om åbenhed, så er vi med på den, siger Peter Huntley. (...)

No need to loosen conflict rules, U.S. FDA head says
reuters.com 1.2.2012
(Reuters) - Congress should not loosen conflict of interest rules to expand the pool of potential U.S. government health advisers, the head of the Food and Drug Administration said on Wednesday.

Lawmakers had proposed bills that would change the rules to make it easier to find more qualified people and speed the review of drugs or devices.

The head of the FDA's drugs division testified in August that the agency was struggling to recruit highly qualified people for its advisory panels. (...)

FDA: J&J delayed reporting insulin pump problems
seattletimes.nwsource.com 11.1.2012
The widening quality problems at health giant Johnson & Johnson have former regulators and analysts mystified, as yet another J&J business - at least the seventh - has come under scrutiny. (...)

This time it's the unit that makes insulin pumps for diabetics, Animas Corp., that's being investigated. The Food and Drug Administration has warned Animas that unless it corrects violations soon, it could face fines and other sanctions for selling faulty insulin pumps and delaying disclosures of serious injuries to patients using its OneTouch Ping and 2020 pumps.

The FDA ordered Animas to explain by Jan. 20 why it kept selling pumps known to fail and also to submit a plan to rectify its failure to promptly report cases where its device might have caused or contributed to death or serious injury.

In a Dec. 27 warning letter posted online by the FDA Tuesday, the agency wrote to Animas and J&J CEO Bill Weldon that inspectors found Animas, based in West Chester, Pa., never reported on one complaint about serious patient injury and delayed reporting on two others. Those patients were hospitalized with dangerously high blood sugar, respiratory failure and coma, and a life-threatening complication called diabetic ketoacidosis caused by lack of insulin to break down blood sugar. (...)

(Anm: Ketoacidosis is a metabolic state associated with high concentrations of ketone bodies, formed by the breakdown of fatty acids and the deamination of amino acids..  (en.wikipedia.org).)

(Anm: Ketoacidose, en fryktet akutt komplikasjon ved diabetes mellitus. På grunn av insulinmangel vil økt fettforbrenning føre til dannelse av ketonlegemer (ketonstoffer). Konsekvensene er surgjøring av organismen, dehydrering og koma. Tilstanden kan utløses hos diabetikere f.eks. i forbindelse med infeksjonssykdommer. Rask behandling med tilførsel av store mengder væske (fysiologisk saltvann) og insulin er påkrevet. Se også diabetes mellitus. Kilde: Store norske leksikon.)

As Doctors Use More Devices, Potential for Distraction Grows
nytimes.com 14.12.2011
Hospitals and doctors’ offices, hoping to curb medical error, have invested heavily to put computers, smartphones and other devices into the hands of medical staff for instant access to patient data, drug information and case studies.

But like many cures, this solution has come with an unintended side effect: doctors and nurses can be focused on the screen and not the patient, even during moments of critical care. And they are not always doing work; examples include a neurosurgeon making personal calls during an operation, a nurse checking airfares during surgery and a poll showing that half of technicians running bypass machines had admitted texting during a procedure.

This phenomenon has set off an intensifying discussion at hospitals and medical schools about a problem perhaps best described as “distracted doctoring.” In response, some hospitals have begun limiting the use of devices in critical settings, while schools have started reminding medical students to focus on patients instead of gadgets, even as the students are being given more devices. (...)

Medtronic settles U.S. probe over doctor kickbacks
reuters.com 12.12.2011
(Reuters) - Medtronic Inc has agreed to pay $23.5 million to settle allegations that it paid kickbacks to doctors to encourage them to use its pacemakers and defibrillators, the U.S. Justice Department said on Monday.

The company was accused of seeking physicians to participate in studies and registries and paying doctors fees of between $1,000 to $2,000 per patient for information and data collected as long as they used Medtronic's devices, according to the Justice Department.

Medtronic caused false claims to be submitted to the federal healthcare programs Medicare and Medicaid, the Justice Department said. The settlement resolves two whistleblower lawsuits against the company.

"Kickbacks, like those alleged here, distort sound medical judgments with financial incentives paid for by the taxpayers," Tony West, assistant attorney general for the Justice Department's civil division, said in a statement.

The company previously disclosed the anticipated settlement and recorded a $24 million expense in its 2011 fiscal year, according to its securities filings. (...)

Financial Payments by Orthopedic Device Makers to Orthopedic Surgeons
Arch Intern Med 2011;171 1759-1765
Background There is ongoing concern over potential conflict of interest inherent in physician relationships with industry. However, there are limited empirical data detailing the prevalence and magnitude of these relationships. Our objective was to use data made available by a US Department of Justice (DOJ) lawsuit to describe the extent of orthopedic surgeons' financial relationships with implant manufacturers. (...)

Conclusions The impact of the DOJ settlement in the short term appears complex, with an increase in payments, a decline in the number of consultants, and an increase in the proportion of consultants drawn from academia. There is a need for clearer specific requirements for disclosure to allow for meaningful long-term analyses to be performed. (...)

Medical devices regulation needs to be overhauled, says cardiologist
BMJ 2011; 343:d6671 (14 October)
The standards of evidence required for licensing medical devices should be the same as for drugs, Peter Wilmshurst told a Royal College of Surgeons meeting this week.
Dr Wilmshurst, a consultant cardiologist at the Royal Shrewsbury Hospital, gave his personal perspective on the need for an overhaul of medical devices regulation after his defence of three defamation claims.

The US medical device company NMT Medical sued Dr Wilmshurst after he spoke of his concerns about the migraine intervention with STARFlex technology (MIST) trial, in which he was the principal cardiologist (BMJ 2008;337:a2412, doi:10.1136/bmj.a2412). The defamation claims recently ended after almost four years when the company went into liquidation.

“I believe concerns about litigation have prevented some doctors from reporting adverse events,” Dr Wilmshurst told the meeting, called “New techniques and new technologies: ethics and patient safety.” (...)

Medical Devices — Balancing Regulation and Innovation
N Engl J Med 2011; 365:975-977 (September 15)
Many Americans benefit from the implantation of medical devices, such as artificial joints and lifesaving defibrillators. Tragically, many also suffer or even die from complications related to medical devices that were never studied in clinical trials before being implanted in patients. As devices have evolved and become more complex, our device-approval system has become incapable of assuring safety and effectiveness. The system we use today was created 35 years ago in an era of much simpler and fewer devices, and it is now outdated.

A recent, but not rare, example provides a cautionary tale about the challenges of ensuring that complex medical devices are both effective and safe. Osteoarthritis of the hip joint is a common and debilitating disorder. Each year, nearly a quarter of a million patients with advanced painful arthritis receive a total hip replacement in the hope that it will restore mobility and improve their quality of life.1 Conventional artificial hip implants consist of a metal ball inserted into a plastic cup. In 2005, a new metal-on-metal design was introduced in which both components were made from a metal alloy. The design was touted as a major innovation that would improve durability and reduce the risk of hip dislocation — advantages that were especially appealing to younger patients but were never tested. (...)

(Anm: Hip OA Linked to Excess Mortality. —Poor physical function from hip OA explained 42.9% of all-cause mortality. (medpagetoday.com 2.7.2015).)

Medical Devices and Health — Creating a New Regulatory Framework for Moderate-Risk Devices
N Engl J Med 2011; 365:977-979 (September 15)
The recently released Institute of Medicine (IOM) report Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years recommends that the Food and Drug Administration (FDA) begin to develop a new regulatory framework for moderate-risk (class II) medical devices.1 Regulation of devices began in 1938, and the regulatory structure reflected the relative simplicity of the devices that were on the market at that time. By the 1970s, the original regulatory framework was no longer adequate or flexible enough to deal with the growing array of device types and the increasing sophistication of new devices. Sporadic public health disasters associated with a few devices generated substantial public concern. Consequently, Congress passed the Medical Device Amendments of 1976,2 which established the framework for the current system. In 1990 and 1997, Congress enacted significant changes to the original statute.3 (...)

Läkemedelsverket lägger stor vikt vid informationen
dagensmedicin.se 1.9.2011
Läkemedelsverket är mycket bekymrat över att hälso- och sjukvården inte rapporterar in fel på medicinteknisk utrustning, skriver Arne Kardell från myndighetens enhet för medicinteknik.

Dagens Medicin skriver i en ledare i nr 34/11 följande:

”Läkemedelsverket är medvetet om den dåliga kunskapen ute i sjukvården, men anser inte att det är myndighetens sak att informera om detta utan hänvisar till att varje vårdgivare är skyldig att upplysa personalen om detta. En märkligt passiv hållning från en myndighet vars uppgift är att förbättra säkerheten i sjukvården. Det borde dessutom vara en självklarhet att Socialstyrelsen och Läkemedelsverket bytte information och samarbetade kring arbetet med att göra den medicintekniska utrustningen säkrare.” (...)

Clinical Trials Neglect the Elderly
newoldage.blogs.nytimes.com.com 19.8.2011
The randomized clinical trial, long the gold standard of medical research, supposedly provides the most reliable data regarding which drugs, devices and procedures prove effective on real patients and which don’t. But when the people enrolled in the trial are quite different from those who will actually use the drug or device or undergo the procedure, the data are far less reliable.

Yet it happens, startlingly often, with old people. They’re not well presented in clinical trials, a fact that undermines their doctors’ best efforts at providing treatment.
“In taking care of older patients, we’re often guessing the best therapy on insufficient data,” said a frustrated Dr. Ken Covinsky, a geriatrician at the University of California, San Francisco. For any given treatment, “the risks and benefits may be very different for older patients, but we have no evidence to use.” (...)

Medical Devices and Health — Creating a New Regulatory Framework for Moderate-Risk Devices
NEJM 2011 (August 10)
The recently released Institute of Medicine (IOM) report Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years recommends that the Food and Drug Administration (FDA) begin to develop a new regulatory framework for moderate-risk (class II) medical devices.1 Regulation of devices began in 1938, and the regulatory structure reflected the relative simplicity of the devices that were on the market at that time. By the 1970s, the original regulatory framework was no longer adequate or flexible enough to deal with the growing array of device types and the increasing sophistication of new devices. Sporadic public health disasters associated with a few devices generated substantial public concern. Consequently, Congress passed the Medical Device Amendments of 1976,2 which established the framework for the current system. In 1990 and 1997, Congress enacted significant changes to the original statute.3 (...)

Medtronic Hires Yale to Review Infuse Safety
medpagetoday.com 3.8.2011
Medtronic, whose spine surgery product called Infuse has come under attack, has agreed to spend $2.5 million for an independent review of its safety and effectiveness by Yale University researchers.

As part of the review, Medtronic will provide the Yale reviewers with patient data from all Infuse clinical trials as well as all reports of adverse events reported to the FDA since Infuse came on the market in 2002.

Harlan Krumholz, MD, a professor of internal medicine at Yale and a prominent cardiologist, will lead the review.

The unprecedented move by Medtronic comes after months of investigative news reports and research studies by independent doctors raising concerns about serious complications with the product.

Those complications were not revealed in medical journal articles published over nearly a decade -- articles that were written by doctors who have received tens of millions of dollars in royalties and other payments from the company. Several of those news reports were published in the Milwaukee Journal Sentinel and MedPage Today.

A U.S. Senate committee is now investigating the matter.

In June, the entire issue of the Spine Journal was devoted to research papers and commentaries focusing on the unreported complications with Infuse.

Spine Journal editor Eugene Carragee, MD, the Stanford University orthopedic surgeon who spearheaded the journal's initiative, said he was delighted by Medtronic's decision to agree to the Yale review. (...)

Medical-device review system doesn't do its job, FDA told
seattletimes.nwsource.com 29.7.2011
Federal health regulators asked the country's leading medical experts two years ago to recommend ways to improve the government's system for approving most medical devices, ranging from pacemakers to X-ray scanners.

WASHINGTON — Federal health regulators asked the country's leading medical experts two years ago to recommend ways to improve the government's system for approving most medical devices, ranging from pacemakers to X-ray scanners. On Friday the experts came back with a surprise answer: scrap it because it fails to protect patients.

Even more surprising, the Food and Drug Administration (FDA) dismissed the idea.

The Institute of Medicine's panel said in a report that the U.S. government should abandon the 35-year-old system used to clear medical devices because it provides little assurance that the implants are actually safe.

The 12-member group's advice, commissioned by the FDA, is not binding. (...)

IOM Tells FDA to Scrap Medical Device Program
JAMA 2011 (July 29)
The Institute of Medicine says that the US Food and Drug Administration’s process to clear low- and moderate-risk devices is fundamentally flawed and should be abandoned. (Image: JAMA, ©AMA)

In an eagerly awaited report, the Institute of Medicine (IOM) said today that thousands of medical devices cleared every year for sale are not assessed for safety and effectiveness, and that the clearance process should be abandoned.

The report criticized the 35-year-old 510(k) process that the US Food and Drug Administration (FDA) uses to allow low- to moderate-risk devices—everything from tongue depressors to heart valves and hip implants—to be sold and used in patient care. The process has come under fire in recent years from consumers, physicians, and industry officials. They’ve contended that it overlooks safety and efficacy and is an unpredictable, inconsistent regulatory pathway. (...)

Experts say medical device review system 'flawed'
seattletimes.nwsource.com 29.7.2011
Federal health regulators asked the country's leading medical experts two years ago to recommend ways to improve the government's system for approving most medical devices, ranging from pacemakers to X-ray scanners. On Friday the experts came back with a surprise answer: scrap it because it fails to protect patients. Even more surprising, FDA summarily dismissed the idea.

Federal health regulators asked the country's leading medical experts two years ago to recommend ways to improve the government's system for approving most medical devices, ranging from pacemakers to X-ray scanners. On Friday the experts came back with a surprise answer: scrap it because it fails to protect patients. Even more surprising, FDA summarily dismissed the idea.

The Institute of Medicine's panel said in a report that the U.S. government should abandon the 35-year-old system used to clear medical devices because it provides little assurance that the implants are actually safe.

The 12-member group's advice, commissioned by the Food and Drug Administration, is not binding. And experts questioned its real-world impact after the FDA immediately distanced itself from the advice it had requested. (...)

Doctors overuse heart treatment, despite guidelines (Leger overforbruker hjertebehandling, til tross for retningslinjer)
reuters.com 11.7.2011
(Reuters Health) - The controversial use of stents days after a heart attack has continued unabated in the United States, even after a landmark study and new guidelines said the pricey therapy does not help patients.

Just over half of patients who have survived at least 24 hours after a heart attack will have a stent -- a small metal mesh tube -- placed to open a blocked coronary artery, and that rate has not changed from 2005 through 2008.

The findings add to concerns about overuse of the heart devices, made by companies such as Boston Scientific, Abbott Laboratories, Medtronic Inc and Johnson & Johnson.

Stenting procedures cost the United States about $12 billion every year, and researchers say it is time doctors take responsibility for the nation's spiraling health costs.
"I think physicians have to rise to the challenge," said Dr. Judith Hochman, a cardiologist at New York University, who led the new work. (...)

Senators Look Into Medtronic, Doctors (Senatorer gransker Medtronic, leger)
online.wsj.com 23.6.2011
The Senate Finance Committee is investigating whether surgeons who received large sums of money from medical-device giant Medtronic Inc. for consulting and other work failed to note complications associated with a Medtronic bone-growth protein that has become widely used in spinal surgery.

The inquiry was triggered in part by an upcoming study in a medical journal showing that numerous complications associated with the product, Infuse Bone Graft, occurred in clinical trials of the product but went unreported in a dozen research papers about those trials that Medtronic sponsored between 2000 and 2009, people familiar with the matter said. (...)

Senators Investigate Medtronic Spine Device
medpagetoday.com 22.6.2011
A U.S. Senate committee has launched an investigation into reports that doctors with financial ties to the medical device company Medtronic were aware of potentially serious complications with a spine surgery product made by the company yet failed to reveal those problems in published journal articles.

Citing news articles based on a Milwaukee Journal Sentinel/MedPage Today investigation, two powerful members of the Senate Finance Committee contacted Medtronic Tuesday demanding an extensive list of documents, including financial records and communications between the company and doctors who have received millions in royalties and other payments from Medtronic over the last decade.

Medtronic was warned not to destroy or make inaccessible any of the documents, data, or other related information in the letter signed by committee chairman Max Baucus (D-Mont.) and senior member Chuck Grassley (R-Iowa). (...)

Device Approval
JAMA. 2011;305(22):2280 (June 8)
A commitment by the Food and Drug Administration (FDA) to require a more stringent approval process for high-risk medical devices remains unfulfilled, said the Government Accountability Office (GAO) in a report presented in an April 13 hearing of the Senate Special Committee on Aging (http://1.usa.gov/hB8QDG).

The GAO had previously reported that the FDA should take steps to ensure that high-risk devices undergo the most stringent premarket review process (http://1.usa.gov/jQlfL5). The FDA has issued a final rule for only 1 type of high-risk device, the GAO testified at the hearing. The remaining 26 types of high-risk devices, such as automated external defibrillators and implantable hip joints, can still enter the US market through a less stringent process.

“The drive toward getting new technologies to market shouldn't be done at the risk of patient safety,” said Committee Chairman Sen Herb Kohl (D, Wis), in a statement. “Faulty medical devices, especially those implanted in the body, can have a disastrous impact on the health of those who use them.” (...)

Patienter fick onödig strålning
dagensmedicin.se 3.6.2011
Flera patienter har utsatts för onödig strålning vid Länssjukhuset Ryhov i Jönköping. Ett fel på röntgenutrustningen gjorde att den tog fler bilder än vad som behövdes.

De felaktiga undersökningarna pågick under fem månader, från oktober 2010 till mars i år. Först efter att en patient fått göra åtta omtagningar av samma bild kontaktades en sjukhusfysiker och ett röntgenrör byttes ut.

Länssjukhuset har anmält händelsen till Strålsäkerhetsmyndigheten. I anmälan skriver sjukhuset att den extra stråldos som patienterna har utsatts för är mycket liten och att risken för framtida men är låg, uppger Sveriges Television. (...)

Public Citizen: Key data left out of Alzheimer's study (Public Citizen: Nøkkeldata utelatt i Alzheimer-studie)
reuters.com 10.5.2011
* Group claims accuracy data excluded from medical journal

* Public Citizen says raises risk of unreliable results

CHICAGO May 10 (Reuters) - A U.S. consumer group alleged on Tuesday that researchers with ties to Eli Lilly and Co (LLY.N) withheld important information from a medical journal in their study of an imaging drug for Alzheimer's disease.

In a letter published in the Journal of the American Medical Association, Public Citizen criticized a Jan. 19 study that assessed the effectiveness of brain scans using Lilly's Amyvid, an experimental dye to detect brain abnormalities.

They said the study authors excluded data on how accurately the scans were interpreted from one physician to the next. (...)

Financial Ties Bind Medical Societies to Drug and Device Makers (Økonomiske bånd mellom medisinske foreninger og legemiddel- og utstyrsprodusenter)
propublica.org 5.5.2011
Billboards from a medical device company near Moscone Center in San Francisco, site of a Heart Rhythm Society convention. Photo by Robert Durell for ProPublica.

SAN FRANCISCO — From the time they arrived to the moment they laid their heads on hotel pillows, the thousands of cardiologists attending this week’s Heart Rhythm Society conference have been bombarded with pitches for drugs and medical devices.

St. Jude Medical adorns every hotel key card. Medtronic ads are splashed on buses, banners and the stairs underfoot. Logos splay across shuttle bus headrests, carpets and cellphone-charging stations. (...)

Doctors' groups welcome medical company dollars
usatoday.com 5.5.2011
SAN FRANCISCO — From the time they arrived to the moment they laid their heads on hotel pillows, the thousands of cardiologists attending this week's Heart Rhythm Society conference have been bombarded with pitches for drugs and medical devices.

Last year's four-day event brought in more than $5 million, including money for exhibit booths the size of mansions and company-sponsored events. This year, there are even more "promotional opportunities," as the society describes them.

Concerns about the influence of industry money have prompted universities such as Stanford and the University of Colorado-Denver to ban drug sales representatives from the halls of their hospitals and bar doctors from paid promotional speaking.

Yet, one area of medicine still welcomes the largesse: societies that represent specialists. It's a relationship largely hidden from public view, said David Rothman, who studies conflicts of interest in medicine as director of the Center on Medicine as a Profession at Columbia University.

Professional groups such as the Heart Rhythm Society are a logical target for the makers of drugs and medical devices. They set national guidelines for patient treatments, lobby Congress about Medicare reimbursement issues, research funding and disease awareness, and are important sources of treatment information for the public.

Dozens of such groups nationwide encompass every medical specialty from orthopedics to hypertension. (...)

Medical Groups Shy About Detailing Industry Financial Support
propublica.org 5.5.2011
When it comes to the money they get from drug and device makers, many medical associations and health advocacy groups would rather not publicize who gave and how much.

In December 2009, Sen. Charles Grassley, R-Iowa, sent a letter asking 33 organizations to list their industry funding and note whether they made the information public.

ProPublica's review of the responses shows wide variations in the groups' reliance on such funding. Those with a heavy proportion of industry support often represented specialists who use pricey drugs and devices.

In contrast, larger advocacy groups reported accepting proportionately less money from industry sources.

Grassley, as well those who research conflicts of interest, say it's impossible to assess potential bias without knowing the scope of such relationships.

If a group gets millions from a company that makes a product used by its members, it is reasonable to wonder whether the guidance it offers on treatments would benefit that company, he said.

For example, federal agencies may want to take into account a group's donors when the group lobbies for new treatments or changes in Medicare coverage. That's only possible if a group's funding is disclosed.

"My feeling is it's not the total answer, but at least it does a lot of good," said Grassley, who is encouraging the groups to post their corporate donors online. "Transparency, the public's right to know, brings some accountability." (...)

Medical Experts Dispute a Hospital’s Claims on Heart Device Data
nytimes.com 20.4.2011
Several medical experts have disputed the basis for a Las Vegas hospital’s claim that patients benefited when cardiologists there switched to heart devices made by a company that paid it consulting fees, saying data to support that claim did not exist.

This month, University Medical Center of Southern Nevada said in a statement, “results to date show significantly improved outcomes for our cardiac patients” who got heart implants made by a little-known company, Biotronik. The statement was attributed to Kathleen Silver, the chief executive of the hospital.

Ms. Silver issued that statement after an article in The New York Times reported that cardiologists there switched in 2008 to using Biotronik devices after that company started paying them thousands of dollars in consulting fees.(...)

Stent studies don't reflect "real world" patients
reuters.com 7.4.2011
NEW YORK (Reuters Health) - Stroke-preventing devices are not being tested in people who resemble the patients most likely to receive them, a new study shows.

The researchers looked at tests being done as part of "post-market surveillance studies," which test products that are already approved and in general use by the public.

They found that patients who had small mesh tubes, called stents, placed into their neck in these studies were healthier than other patients in a broader nationwide registry of people who received stents.

"We were surprised," said Dr. Robert Yeh, the lead author of the study and a cardiologist at Massachusetts General Hospital and Harvard Medical School.

"The intention and presumption of most post-marketing studies is that they represent the group of patients that we see in clinical practice."

Yet the patients in the larger registry database who weren't in the post-marketing studies were 50 percent more likely to have had a stroke in the past, and were four times as likely to die in the hospital, Yeh said.

"When we look at these results (from post-marketing surveillance) we should be a little bit careful in applying them to the patient in front of us," Yeh told Reuters Health. (...)

Bill would post every physician's Medicare billing data on Internet
ama-assn.org 4.4.2011
Doctor privacy advocates defend a 30-year ban on releasing data from challenges on Capitol Hill and in the courts.

Washington -- A Senate bill aimed at curtailing Medicare fraud would publish physician billing data online, letting viewers determine how much individual doctors earn annually from the program.

The release of the data has been prohibited by a court ruling for more than 30 years. But some lawmakers recently stepped up their efforts to lift the ban and bring Medicare billing data to light to prevent fraud. (...)

UPDATE 1-Pfizer, GSK paid $262 mln to U.S. doctors in 2010 (Pfizer, GSK betalte 262 millioner dollar til amerikanske leger i 2009)

U.S. Sues Boston Scientific
manufacturing.net 28.1.2011
MINNEAPOLIS (AP) -- The U.S. government sued Boston Scientific Corp. on Thursday, alleging its Guidant unit knew some of its implantable heart devices were defective but continued to sell them anyway, putting patients' lives at risk.

In a complaint filed in federal court in Minnesota, the government alleges Guidant knew as early as April 2002 that one model of its implantable cardioverter defibrillators might not deliver a life-saving jolt when needed. A similar problem was found in another model in 2003.

The complaint alleges Guidant fixed the problems, but continued to sell the defective devices it had in stock. It also did not recall the devices already on hospital shelves. In addition, the complaint alleges the company hid the issue from patients, doctors and the Food and Drug Administration and continued to file for Medicare reimbursements for defective implants. (...)

Medical Device Registries Improve Patient Safety
ivanhoe.com 29.12.2010
(Ivanhoe Newswire) – A detailed and standardized national registry of commonly used joint replacement devices would improve patient outcomes and create clinical and financial efficiencies, according to this study.

Information on the more than 600,000 total knee and hip replacements performed annually in the United States could enhance patient safety and quality of care, as well as providing a foundation for more in-depth research projects that will contribute to better outcomes as increasing numbers of replacements are performed in the future. (...)

2 Senators Raise Questions on Use of Medtronic Device
nytimes.com 27.12.2010
Two senators are raising new questions about an experimental use of a Medtronic device in spinal surgery on veterans and soldiers at the Walter Reed Army Medical Center from 2002 to 2004.

Senators Max Baucus, Democrat of Montana and chairman of the Senate Finance Committee, and Charles E. Grassley of Iowa, the committee’s ranking Republican, wrote the commanding general of Walter Reed on Dec. 17 to ask about safeguards in a study by three Army surgeons. Senator Grassley’s office provided the letter to The New York Times.

The senators asked what the Army was doing to investigate certain back surgeries at Walter Reed and whether patients had been told they were receiving devices for uses not cleared by the Food and Drug Administration. They also asked how Army protocols could ensure proper review of medical tests involving soldiers and veterans. The surgeons, who have received money from Medtronic, had implanted and written about a Medtronic device called Hydrosorb Mesh, which contained a bone-growth material called Infuse. (...)

Secrets of the System
Top Spine Surgeons Reap Royalties, Medicare Bounty

online.wsj.com 2o.12.2010
Norton Hospital in Louisville, Ky., may not be a household name nationally. But five senior spine surgeons have helped put it on the map in at least one category: From 2004 to 2008, Norton performed the third-most spinal fusions on Medicare patients in the country.

The five surgeons are also among the largest recipients nationwide of payments from medical-device giant Medtronic Inc. In the first nine months of this year alone, the surgeons—Steven Glassman, Mitchell Campbell, John Johnson, John Dimar and Rolando Puno—received more than $7 million from the Fridley, Minn., company. (...)

Regulation is flawed (Regulering er mangelfull)
BMJ 2010; 341:c7016 (7 December)
Something is fundamentally wrong with a drug regulatory system that makes it increasingly difficult to do independent pragmatic trials of widely used but unproven drugs yet licenses a ridiculously expensive drug with no randomised evidence that it improves clinical outcomes over the cheap unlicensed preparation.1 2 (...)

FDA is gold standard of review (FDA er gullstandard for saksbehandling)
BMJ 2010; 341:c7004 (7 December)
Brownlee and Lenzer had clearly made up their minds about the Food and Drug Administration (FDA) and medical device community before writing their article.1 It is unfortunate that they didn’t acknowledge the cutting edge advances and improvements to patient care medical devices provide every day.

Today, with such medical advances, the average American can expect to live to 78, a 65% increase over the past 100 years. The medical device industry is perhaps one of the greatest unsung contributors to increased life expectancy. Research has shown that since 1980 death rates have declined 16% and Americans spend 56% fewer days in hospital, partly because of medical devices. (...)

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. (...)

Surveillance and medical devices (Overvåkning og medisinsk utstyr)
BMJ 2010; 341:c6999 (7 December)
Lenzer and Brownlee highlight the potential value for postmarketing surveillance,1 but this is true not only for “complex” or new devices.

The UK government’s decision in 2001 to replace reusable tonsillectomy instruments with single use devices, because of the risk from variant Creutzfeldt-Jakob disease, is a lesson in point. These were not complex devices, but widespread adverse events followed, and they were subsequently withdrawn in England. In Wales, we did not return to reusable instruments, but tonsillectomy temporarily ceased before the procurement and introduction of specified single use instruments, which were then surveyed in use.2 (...)

Medical Devices and the FDA Approval Process
Arch Intern Med. 2010;170(20):1831-1833 (November 8)
Balancing Safety and Innovation

The use of medical devices has greatly increased during the past decade. Indeed, more than 8000 new medical devices are marketed in the United States annually.1 The US Food and Drug Administration (FDA) is responsible for assuring the safety and effectiveness of devices prior to and following approval for use in the United States. The FDA classifies medical devices according to risk of causing harm. Class I and II devices are considered to be low risk and approval may be accomplished through a relatively simple "premarket notification" or 510(k) clearance, which does not require clinical data. Class III devices are those considered high risk; Class III devices generally require a premarket approval (PMA) process that includes clinical data showing safety and effectiveness. When Congress established device classes in 1976, its intent was that all Class III devices eventually would be required to undergo premarket review through the more stringent PMA process.2(p17) (...)

J&J, DePuy Face Potential Half-Billion Dollar U.K. Suit Over Hip Implants (J&J, DePuy møter mulig britisk søksmål på en halv million dollar for hofteimplantater)
topdevicecompanies.com 27.10.2010
October 27, 2010
Johnson & Johnson’s DePuy subsidiary counts more than 10,000 patients in the United Kingdom who need new surgery to replace hip implants. The patients were notified by DePuy they should have their operations reviewed to see if components used in their artificial joints were causing problems, in come cases tumors and leeching toxic metals into their blood. They and other patients claiming an inability to walk or excrutiating pain are expected to take part in a class action suit estimated to cost J&J more than $545 million. (Click here for more)

“10,000 Hip Replacement Patients Told Their Operations May Need To Be reversed After Receiving Faulty Implants” – Daily Mail (10/24/10) (...)

Gruppesøksmål mot DePuy Ortopedi
news-medical.net 27.10.2010
Den ledende advokatkontor i Nurenberg, Paris, Heller & McCarthy har inngitt et gruppesøksmål mot Johnson & Johnson's kunstige ledderstatning selskap DePuy Ortopedi, Inc., på vegne av klienter som led skader som følge av selskapets nå-tilbakekalte hip nye enheten. (Sak nr. 1:10 CV02222, US District Court, Northern District of Ohio, Eastern Division)

"Revisjon" Surgeries Påkrevd

DePuy nylig tilbakekalte to hofteoperasjon produkter - ASR Hip Resurfacing System og ASR XL Acetabular System - etter data viste at innen fem år, en av åtte pasienter trengte "revisjon operasjoner," som er nødvendig når en kunstige leddet ikke riktig passform eller bryter ned for tidlig. Om 93 000 mennesker rundt om i verden har fått en av disse potensielt feil hofte implantater.

De juridiske fagfolk på Nurenberg, Paris, Heller & McCarthy forvente at gruppesøksmål å inkludere hundrevis, om ikke tusenvis, av ofre. Ledet av advokat David M. Paris, søksmålet er at søker å hjelpe de som har mottatt en DePuy ASR hip implantat og erfarne smerter, hadde problemer med å gå, eller trengte en revisjon kirurgi for å fikse en defekt hip implantat. (...)

Grassley to FDA: How do you handle docs' conflicts of interest? (Grassley til FDA: Hvordan ivaretas legers interessekonflikter?)
massdevice.com 25.10.2010
Sen. Charles Grassley asks the Food and Drug Administration for details on how it handles potential conflicts of interest for physicians who are on medical device or pharmaceutical firms' payrolls.

Sen. Charles Grassley fired off the latest in a series of letters aimed at the healthcare bureaucracy, this times asking Food & Drug Administration chief Dr. Margaret Hamburg how her agency handles physicians' potential conflicts of interest.

The Iowa Republican, citing financial disclosure forms filed by Medtronic Inc. (NYSE:MDT) and ethical guidelines for physicians who are on medical device and pharmaceutical firms' payroll, Grassley asked Hamburg to describe how the agency treats "financial interests that may present a conflict."

Noting that FDA rules require the disclosure of "significant financial interests" of the clinical investigators companies employ, Grassley asked Hamburg to specify how the agency decides whether those interests affect "the rights and welfare of human subjects" or the integrity of trials.

"Assuming there are no compelling circumstances, are there financial interests that the FDA would consider too significant a conflict to be appropriate for a clinical investigator to be involved in a study?" Grassley asked. "Does FDA advise manufacturers on specific steps that should be taken to minimize potential bias? Are there actions that FDA expects companies to take to manage potential conflicts of interest?" (...)

Grassley quizzes FDA chief on conflicts
startribune.com 22.10.2010
A U.S. senator has asked the head of the Food and Drug Administration whether the agency monitors medical device companies' payments to doctors who are involved in clinical studies of the companies' products.

In a letter to FDA Commissioner Margaret Hamburg sent Friday, Sen. Charles Grassley cites information about Medtronic Inc. that surfaced in a separate inquiry.

That query discovered that of 50 clinical investigators studying Medtronic products, "almost all ... received significant payments" from the Fridley-based medical technology company.

In some cases, doctors also had a "proprietary interest in the product being tested and a financial arrangement where the value of compensation could be influenced by the outcome of the study," Grassley said. (...)

VA doctor's Medtronic ties spark more Grassley queries
startribune.com 21.10.2010
Iowa senator asks whether a high-level VA official still has links to the medical technology company.

Sen. Charles Grassley has sent letters to Medtronic Inc. as well as the head of the U.S. Department of Veterans Affairs asking for more information about a high-ranking official at the VA who was once a consultant for the medical technology company. (...)

Grassley questions new VA official's ties to Medtronic
massdevice.com 8.10.2010
Sen. Charles Grassley wants answers about a newly appointed Veterans Administration official's ties to Medtronic Inc.

The appointment of a former Medtronic Inc. (NYSE:MDT) consultant to one of the top spots at the U.S. Dept. of Veterans Affairs is drawing scrutiny from Sen. Charles Grassley (R-Iowa).

Grassley, a high-profile thorn in the side of medical device and pharmaceutical firms when it comes to the transparency of their relationships with physicians, sent a letter to VA secretary Eric Shinseki asking whether Dr. Stephen Ondra's judgment is likely to be swayed by his association with the Fridley, Minn.-based medical device monolith.

Grassley asks Shinseki whether "policy advice and decisions at the VA are vulnerable to potential conflicts of financial interest" in the Sept. 28 letter, according to the Minneapolis Star Tribune. (...)

VA official's Medtronic ties raise concerns
startribune.com 6.10.2010
Sen. Grassley questions whether the past relationship could create conflicts of interest.

A prominent U.S. senator has raised questions about the appointment of a former Medtronic Inc. consultant to a top position at the U.S. Department of Veterans Affairs, according to documents obtained by the Star Tribune.

In a Sept. 28 letter to Veterans Affairs Secretary Eric Shinseki, Sen. Charles Grassley asks whether Dr. Stephen Ondra's "policy advice and decisions at the VA are vulnerable to potential conflicts of financial interest" given his prior relationship with the Fridley-based medical technology giant. (...)

FDA moves toward tighter medical device oversight
news.yahoo.com 3.8.2010
WASHINGTON – Makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed each year.

The Food and Drug Administration released recommendations Tuesday night designed to improve oversight of the U.S. device industry, including the government's ability to revoke approval for products that prove unsafe or ineffective.

The FDA's report comes nearly a year after FDA's medical devices division endured a storm of criticism from public health advocates and lawmakers. (...)

FDA Moves Toward Tighter Medical Device Oversight
pharmapro.com 4.8.2010
WASHINGTON (AP) — Makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed each year.

The Food and Drug Administration released recommendations Tuesday night designed to improve oversight of the U.S. device industry, including the government's ability to revoke approval for products that prove unsafe or ineffective.

The FDA's report comes nearly a year after FDA's medical devices division endured a storm of criticism from public health advocates and lawmakers. (...)

Medical publication ghostwriting report gets a mixed review
orthosupersite.com 22.7.2010
Medical publishing was the latest industry to be put under the microscope in the push for greater transparency in many fields when the office of United States Senator Charles Grassley released a new report on medical ghostwriting on June 24, but at least one medical publishing association is questioning some of its contents.

The staff report of the Committee on Finance on the practice of medical ghost writing followed a 2-year review of the role that pharmaceutical and medical device companies play in developing articles for publication in medical journals. According to a press release from the senator’s office, Grassley has urged the National Institutes of Health (NIH) to incorporate the report’s findings in its new, final disclosure guidelines for federal grant recipients. (...)

June's Biotech Busts And Breakthroughs
forbes.com 2.7.2010
Forbes' monthly look at the best and worst performers in the drug and medical device industries.

The first rule about biotech is that the unexpected will happen. June was proof. (...)

U.S. experts weigh how to reduce radiation from scans (Amerikanske eksperter vurderer hvordan stråling kan reduseres)
reuters.com 24.6.2010
(Reuters) - The Food and Drug Administration should step in to protect patients from radiation from CT scanners, according to one expert in the ongoing debate over the safe use of medical imaging.

Others say doctors should stop ordering so many scans, which often find conditions that might have been better left untreated. But they argue against FDA regulation, which may keep companies from investing in new innovations.

Both sides of the debate, published on Wednesday on the New England Journal of Medicine website, reflect ongoing concerns about how to best use advanced diagnostic tests.

Overuse of the costly scans has been a concern of policymakers for the past few years, prompting cuts in Medicare reimbursement. And recent studies on radiation risks from computed tomography or CT scans and several cases of accidental radiation overdoses have drawn the attention of the FDA.

A CT scan of the chest exposes a patient to more than 100 times the radiation of an X-ray and an abdominal CT scan is roughly equivalent to 400 chest X-rays. (...)

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

Industry Gifts Okay with Most Doctors (Gaver fra industrien er ok for de fleste leger)
medpagetoday.com 22.6.2010
Increased emphasis on conflicts of interest has yet to sway physicians' generally positive attitudes toward drug and device manufacturers' marketing activities, a survey of almost 600 attending physicians and trainees showed.

More than 70% of respondents saw nothing inappropriate about attending sponsored lunches, and 25% had no problems with accepting large gifts from industry representatives, according to an article in the June issue of Archives of Surgery.

Surgeons, trainees, and respondents unfamiliar with institutional policies on conflict of interest tended to have more positive attitudes about gifts. (...)

(Anm: Physician Attitudes Toward Industry - A View Across the Specialties. Arch Surg. 2010;145(6):570-577 (June).)

(Anm: Gaver, smøring (gave gitt som bestikkelse) etc. (mintankesmie.no).)

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

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

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

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

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

Blodtrykksapparater på legekontorer
Tidsskr Nor Legeforen 2010; 130:1233-5 (17.6.2010)
Bakgrunn. Blodtrykksmåling er en av de mest benyttede prosedyrer i klinisk medisin. Vurdering og behandling av blodtrykk genererer store utgifter og har betydelige implikasjoner for de individer det angår. Det er viktig at blodtrykksapparatene gir nøyaktige målinger. Kvikksølvapparater har vært dominerende i hundre år, men erstattes nå av andre typer. Det foreligger ikke nasjonale anbefalinger angående apparatvalg. Målet med denne studien var å kartlegge hvilke blodtrykksapparater som brukes i allmennpraksis og i hvilken grad det var etablert rutiner for kontroll og kalibrering av apparatene. (...)

Fortolkning. Det ser ut til å være behov for å etablere rutiner for kvalitetssikring av blodtrykksapparater i norsk primærhelsetjeneste. (...)

Norske pasienter er prøvekaniner
tidsskriftet.no 3.6.2010
I Norge foregår det utstrakt og fordekt utprøvning av medisinsk utstyr utenfor kliniske studier. Produktene brukes på vanlige pasienter i den kliniske hverdag, ikke sjelden uten at disse er informert, skriver medisinsk redaktør i Tidsskriftet, Michael Bretthauer.

– Antakelig skjer de fleste utprøvninger av nytt medisinsk utstyr på denne fordekte måten. Det er bekymringsfullt, skriver Bretthauer på lederplass. (...)

«Skall jag inte randomiseras?»
Tidsskr Nor Legeforen 2010; 130:1119 (3.6.2010)
I 2007 kjøpte Sykehuset Telemark og Radiumhospitalet hver sin robot som opererer prostatakreft. Samlet innkjøpspris var rundt 30 millioner kroner (1). Kritiske røster påpekte at det ikke fantes randomiserte studier som viser at robotkirurgien er bedre enn vanlig kirurgi og foreslo å gjennomføre en slik studie med de nyinnkjøpte robotene, men dette ble avvist av fagmiljøet. I en fersk systematisk oversiktsartikkel konkluderes det nå at det fortsatt ikke finnes gode kliniske studier som belegger nytten av robotkirurgi ved prostatakreft (2). Pasienter i Oslo og Telemark blir operert med denne teknikken hver eneste dag, uten at vi vet om dette er god behandling. (...)

F.D.A. Toughens Process for Radiation Equipment (FDA skjerper undersøkelser av stråling fra utstyr)
nytimes.com 8.4.2010
The Food and Drug Administration said Thursday that it was taking steps to reduce overdoses, underdoses and other errors in radiation therapy by strengthening the agency’s approval process for new radiotherapy equipment. (...)

Too Much Radiation? The FDA Wants to Know (For mye stråling? FDA ønsker å vite)
usnews.com 30.3.2010
Agency set to open two days of public comment on risks from scans (...)

In February, the FDA noted that the benefits of medical imaging were considerable because they've led to disease being diagnosed earlier, allowing better treatment options, including "image-guided therapies that help save lives every day."

But to keep radiation exposure to a minimum, the agency asked that doctors and patients keep two principles in mind: that each procedure must be justified and that the radiation be given at the minimum dose required. (...)

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

Staffer: FDA suppressed imaging safety concerns (Ansatt: FDA unnlot å informere om sikkerhetsbekymringer ved bildebehandling)
boston.com 30.3.2010
A former Food and Drug Administration scientist said Tuesday his job was eliminated after he raised concerns about the risks of radiation exposure from high-grade medical scanning.

Dr. Julian Nicholas told an audience of imaging specialists that he and other FDA staffers "were pressured to change their scientific opinion," by managers in the agency's medical device division.

Nicholas, now a physician at the Scripps Clinic in San Diego, said he and eight other staffers raised their concerns with the division's top director last September.

"Scientific and regulatory review process for medical devices was being distorted by managers who were not following the laws," Nicholas said. A month later Nicholas' position was "terminated," he said.

The allegations about suppression of scientific dissent within FDA are not the first, and come at an inopportune time for the agency. (...)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(Anm: Association of anticholinergic burden with adverse effects in older people with intellectual disabilities: an observational cross-sectional study. Conclusions Older people with intellectual disabilities and with mental health conditions were exposed to high anticholinergic burden. This was associated with daytime dozing and constipation. The British Journal of Psychiatry Dec 2016, 209 (6) 504-510.)

(Anm: New study links autism to mutations in mitochondrial DNA (medicalnewstoday.com 31.10.2016).)

(Anm: Økning i dødsfall blant pasienter med psykiske lidelser må etterforskes, sier parlamentsmedlem. (Rise in deaths of mental health patients needs investigating, says MP.) BMJ 2016;352:i518 (Published 26 January 2016).)

(Anm: Medisinske feil — den tredje største dødsårsaken i USA. Medisinske feil inkluderes ikke i dødsattester eller i rangeringen av dødsårsaker. (...) Medisinske feil "fører til mer enn 250 000 dødsfall i USA årlig". (Medical error—the third leading cause of death in the US. Medical error is not included on death certificates or in rankings of cause of death. (...) Medical error 'causes more than 250,000 deaths in the U.S. annually.) BMJ 2016;353:i2139 (Published 03 May 2016).)

(Anm: Forskere: Medisinske feil nå tredje største dødsårsak i USA (Researchers: Medical errors now third leading cause of death in United States) (washingtonpost.com 3.7.2016).)

(Anm: Legemiddelfirmaer har inngått forlik om påstander om villeding av leger om overlevelsesdata for kreft. (Drug companies settle claim of misleading doctors on cancer survival data) (- Medisinsk svindel sto for mer enn halvparten av 3,5 milliarder dollar som ble utbetalt i erstatninger i fjor. Vanligvis involverte dette beskyldninger om bestikkelser betalt for å generere falske pasienter eller unødvendige behandlinger og resepter som er belastet Medicare.) BMJ 2016;353:i3361 (Published 15 June 2016).)

(Anm: Den britiske regjeringen har drevet lobbyvirksomhet overfor EU-kommisjonen for å få vedtatt en mer avslappet tilnærming til reguleringer av legemidler, medisinsk utstyr og mat, ifølge et brev som BMJ har fått tilgang til. (The UK government has been lobbying the European Commission to adopt a more relaxed approach to regulating drugs, devices, and food, a letter seen by The BMJ has shown.) BMJ 2016;353:i3357 (Published 15 June 2016).)

(Anm: Gruppe (Transparency International) ber om flere tiltak for å takle korrupsjonen innen legemiddelindustrien. (Group calls for more to be done to tackle corruption in the pharmaceutical industry) (…) På begynnelsen av 2016 har én av 10 korrupsjonsundersøkelser i USA involvert legemiddelfirmaer, hvilket ifølge rapporten er et langt høyere antall saker enn det som involverer banksektoren. BMJ 2016;353:i3099 (Published 02 June 2016).)

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

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

Scientists Say F.D.A. Ignored Radiation Warnings (Forskere sier at FDA ignorerte advarsler mot stråling)
nytimes.com 28.3.2010
WASHINGTON — Urgent warnings by government experts about the risks of routinely using powerful CT scans to screen patients for colon cancer were brushed aside by the Food and Drug Administration, according to agency documents and interviews with agency scientists.

After staying quiet for a year, the scientists say they plan to make their concerns public at a meeting of experts on Tuesday called by the F.D.A. to discuss how to protect patients from unnecessary radiation exposures. The two-day meeting is part of a growing reassessment of the risks of routine radiology. The average lifetime dose of diagnostic radiation has increased sevenfold since 1980, driven in part by the increasing popularity of CT scans. Such scans can deliver the radiation equivalent of 400 chest X-rays. (...)

Teknologene omformer sykehusene
innodesign.no 1.2.2010
Utviklingen innen blant annet medisinsk bildeteknologi er driveren i omformingen av norsk helsevesen.

– Vi er midt i en revolusjon på linje med den industrielle.

Regjeringens helsereform er blant annet en konsekvens av den teknologiske utviklingen innen medisinsk diagnostisering og behandling.

Det sier professor Dr. med. Erik Fosse ved Intervensjonssenteret på Rikshospitalet. (...)

New studies question FDA's medical approval process (Nye studier stiller spørsmål ved FDAs medisinske godkjennelsesprosess)
examiner.com 31.12.2009
The US Food and Drug Association (FDA) has come under fire once again this week. Two independent studies were published that are critical of the agency's approval process for medical devices. These findings may prove to have long lasting effects in the US justice system. A court case decided in 2008, Riegel versus Medtronic, concluded that approval from the FDA grants companies that produce medical devices free and clear of lawsuits resulting in injuries from their products. (...)

The other study, conducted by researchers from the FDA and Boston’s Beth Israel Deaconess Medical Center, will be published in the upcoming issue of the American Journal of Therapeutics, indicating that about 40% of the studies used to decide what devices are approved lack clear definitions of safety requirements."

These studies follow hot on the heels of other lawsuits with dire consequences that involved FDA approved drugs. Recent headlines featuring tragic birth defects caused by FDA approved antidepressants such as Zoloft and Paxil have shaken consumer confidence in the agency's standards. Even seemingly benign medicine with the FDA's seal of approval is causing grave concern. A good example is the popular denture creams, Fixodent and Poligrip, which are currently facing litigation for zinc poisoning. (...)

FDA corruption in question (...)

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

Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices
JAMA. 2009;302(24):2679-2685 (December 23/30)
Context Medical devices are common in clinical practice and have important effects on morbidity and mortality, yet there has not been a systematic examination of evidence used by the US Food and Drug Administration (FDA) for device approval. (...)

Conclusion Premarket approval of cardiovascular devices by the FDA is often based on studies that lack adequate strength and may be prone to bias. (...)

F.D.A. to Seek New Standards on Human Test Data
nytimes.com 29.12.2009
The Food and Drug Administration is developing guidelines that will set tougher scientific standards for data from tests on humans that makers of medical devices submit when seeking approval of their products, a top agency official said. (...)

In recent years, the agency has come under criticism from lawmakers, researchers and patient advocates for the standards it uses in approving medical devices. The issue of F.D.A. oversight has also taken on particular significance because of a recent United States Supreme Court decision that has shielded makers of high-risk devices from patient lawsuits if their product was approved by the agency. (...)

Medical Device Studies Lack Scientific Rigor, Researchers Find
businessweek.com 29.12.2009
Dec. 29 (Bloomberg) -- Cardiac pacemakers, stents and other medical devices implanted each year in hundreds of thousands of U.S. heart patients often are approved by government regulators based on insufficient scientific review, researchers said.

About two of three cardiovascular devices approved by the U.S. Food and Drug Administration from 2000 to 2007 were tested in a single clinical trial rather than multiple studies, said scientists at the University of California, San Francisco. Eighty-eight percent of the studies failed to include, as a primary goal, a direct clinical measure of whether patients felt better, their heart function improved or they lived longer, the researchers found.

Senator Charles Grassley, a Republican from Iowa, has criticized the FDA’s device review process as too friendly to the industry. The agency said in a Sept. 24 report that its approval of a knee implant made by Hackensack, New Jersey-based ReGen Biologics Inc. was flawed and needed to be re-examined. The FDA asked the Institute of Medicine, an advisory body, to review the approval procedure used for most medical devices, though not for the majority of cardiovascular devices. (...)

Journal editor gets royalties as articles favor devices
jsonline.com 24.12.2009
In 2002, Thomas Zdeblick, a University of Wisconsin orthopedic surgeon who has pocketed millions of dollars in royalties from the spinal device maker Medtronic, took over as editor-in-chief of a medical journal about spinal disorders.

It would be the beginning of a beautiful friendship.

In the years to come, Zdeblick would receive more than $20 million in patent royalties from Medtronic for spinal implants sold by the company. And the medical journal he edited would become a conduit for positive research articles involving Medtronic spinal products, a Journal Sentinel analysis found.

Zdeblick took over editorship of the Journal of Spinal Disorders & Techniques seven years ago. Since then, studies involving Medtronic spinal products or that were funded by Medtronic appeared in the journal at least once per issue, on average. (...)

Doctors' Spat Exposes FDA Loophole
online.wsj.com 23.12.2009
At Northwestern University's prestigious research hospital, one heart doctor is making a serious accusation against another. Nalini Rajamannan alleges that Patrick McCarthy, her former professional idol, engaged in "human experimentation" on patients' hearts without their approval.

Dr. McCarthy, a noted surgeon, categorically denies it. "Does that sound plausible?" he says.

As part of the brawl, Dr. Rajamannan sought a financial agreement with Northwestern that included a $2 million endowed research chair.
The dispute centers on a silver-dollar-sized piece of silicone and metal known as a Myxo ring, used to pinch together leaky heart valves. Dr. McCarthy invented it. (...)

Grassley Works for Disclosure of Drug Company Payments to Medical Groups (Grassley arbeider for offentliggjøring av legemiddelfirmaers betaling til medisinske foreninger)
pharmatimes.com 8.12.2009
WASHINGTON, Dec. 8, 2009 --- Senator Grassley has asked 33 medical groups for information about the financial backing they get from the pharmaceutical, medical device and insurance industries.

"These organizations have a lot of influence over public policy, and people rely on their leadership. There’s a strong case for disclosure and the accountability that results," Grassley said. (...)

Senator seeks sources of health groups' funds
reuters.com 8.12.2009
WASHINGTON (Reuters) - The senior Republican on the Senate Finance Committee has asked the American Medical Association and 32 other medical groups to disclose the financial backing they receive from drug and medical device manufacturers and insurance companies. (...)

Senator Grassley Seeks Financial Details From Medical Groups
nytimes.com 7.12.2009
A top Republican senator, Charles E. Grassley, has sent letters to the American Medical Association, the American Cancer Society and 31 other disease and medical advocacy organizations asking them to provide details about the amount of money that they and their directors receive from drug and device makers.
Such funding amounts are often considered proprietary by the organizations and their directors, but critics contend that the industry’s sway over such groups leads them to lobby on industry’s behalf. (...)

Dent-O-Sept-lærdommer
Tidsskr Nor Legeforen 2009; 129:2330 (19.11.2009)
Det må settes strengere krav til mikrobiologisk renhet for medisinsk utstyr, særlig det som brukes til de mest sårbare pasientgruppene.

– I dag er det strengere krav for sjampo og hudkrem enn for medisinsk utstyr, sier overlege Bjørn G. Iversen. (...)

En tredel av pasientene ble ikke smittet direkte fra munnpenslene, men indirekte via sykehuspersonalet, medisinsk utstyr og miljøet. For de mest sårbare pasientene kan nesten apatogene bakterier likevel være sykdomsfremkallende. Da holder det ikke at utstyret er rent, det må være høygradig desinfisert, og helst sterilt, sier han.

Ingen ble stilt strafferettslig ansvarlig for utbruddet, noe Iversen stiller seg svært kritisk til.

– Det strider mot min rettsfølelse, sier han. Iversen disputerte for dr.philos.-graden ved Universitetet i Oslo 23.9. 2009. (...)

Health-Bill Disclosure Rule Is Resisted
online.wsj.com 13.11.2009
At Issue, Drug Makers' Sponsorship of Doctors' Continuing Education Classes

WASHINGTON—Health legislation moving through Congress would force drug makers to disclose how much they spend on continuing medical education classes for doctors, sparking some resistance from the industry.

For-profit continuing medical education companies have seen revenue fall by double digits in the last year, according to industry statistics, following congressional investigations into the influence of drug makers on medical research and course content. (...)

At Top Schools, More Than Half the Profs Have Industry Ties
By Jacob Goldstein
blogs.wsj.com 4.11.2009
Sometimes it seems like everybody has financial ties to the drug or device industry. As it turns out, it’s only a little more than half of everybody.
A survey conducted in 2006-07 and published this week in the journal Health Affairs found that 53% of academic research faculty in the life sciences at top schools reported financial ties to industry. (...)

Device group inefficiently uses adverse-event reports
modernhealthcare.com (29.10.2009)
A new study from the HHS inspector general's office has found that while overall reporting of medical device adverse events increased significantly between 2003 and 2007, the Food and Drug Administration's Center for Devices and Radiological Health, or CDRH, has done an inadequate job of using those reports to detect and address product safety concerns.“We found that CDRH has not documented follow-up on adverse events, nor does it consistently read adverse-event reports for the first time in a timely manner,” wrote HHS spokesman Don White in an e-mail sent to reporters. “In addition, CDRH rarely acts when manufacturers and user facilities submit reports late.” (...)

Doctors' disclosure list less complete than industry's
boston.com 7.10.2009
Doctors who receive money from drug or medical device makers are expected to reveal those payments when speaking at professional meetings or submitting a manuscript to a medical journal. A new study led by Boston researchers found that the accuracy of physicians' disclosures fell short when compared to what orthopedic device makers reported. (...)

Helseutstyr kan være laget av barn
nrk.no 5.9.2009
Norske sykehus bruker medisinsk utstyr som kan være laget av barn.

Mye medisinsk utstyr produseres under svært dårlige arbeidsforhold i Pakistan og India, og barnearbeid er svært vanlig.

Dette dokumenterte Dagsrevyen allerede for 14 år siden, mye tyder på at problemet er like stort i dag.

- Det finnes nok helt sikkert sånne produkter også i dag. Hvor mange det er, vet vi ikke, sier president Torunn Janbu i Den norske lægeforeningen.

- Det blir galt om vi kjøper inn ting til helsevesenet som har gått utover helsen til de som har laget det, slår hun fast overfor NRK Dagsrevyen. (...)

U surgeon's deals with Medtronic draw fire (Kirurg ved University of Minnesota kritiseres for avtaler med Medtronic)
startribune.com 29.7.2009
Sen. Charles Grassley, R-Iowa also is scrutinizing whether the University of Minnesota adequately oversees potential conflicts of interest.

A top spine surgeon at the University of Minnesota who has reaped more than $1 million consulting for Medtronic Inc. is facing tough questions from a prominent U.S. senator investigating financial conflicts in medicine. (...)

Top UCLA surgeon is demoted after failing to disclose conflicts of interests (Toppkirurg ved UCLA degradert etter å ha unnlatt å opplyse om interessekonflikter)
BMJ 2009;339:b3071 (29 July)
A top orthopaedic surgeon from the University of California, Los Angeles (UCLA) has been demoted after failing to disclose financial links with the medical companies whose products he was researching.

The Wall Street Journal (http://online.wsj.com, 22 Jul, "Surgeon faces probe of research") reports that Jeffrey Wang allegedly failed to tell the university about payments of $459 500 he received between 2004 and 2007 from the companies. Charles Grassley, the US Republican senator who has pursued unreported payments by drug companies to doctors and researchers, is said to have written to the university’s vice chancellor about the payments. (...)

The New Sentinel Network — Improving the Evidence of Medical-Product Safety
healthcarereform.nejm.org July 27th
In 2007, Congress directed the Food and Drug Administration (FDA) to create a new postmarketing surveillance system that will, by 2012, be using electronic health data from 100 million people to prospectively monitor the safety of marketed medical products.1 This new system is intended to complement existing systems of “spontaneous” adverse-event reporting. In May 2008, the FDA announced the Sentinel Initiative, which would “access the capabilities of multiple, existing data systems (i.e., electronic health record systems, medical claims databases).”2 The network of data systems is intended both to detect signals (i.e., higher-than-expected rates of adverse outcomes) and to confirm signals, including those suggested by other sources, and to do so rapidly and quantitatively. At a recent Senate hearing before her confirmation, FDA Commissioner Margaret Hamburg stated that close postmarketing monitoring of medical-product safety would remain a high priority during her tenure.3 (...)

Surgeon Faces Probe of Research (Kirurgs forskning granskes)
online.wsj.com 22.7.2009
A top surgeon at the University of California, Los Angeles, has lost his position as executive director of its spine center and faces an investigation by the school into his research after allegedly failing to disclose he was being paid by several companies whose products he was studying.

Between 2002 and 2008, Jeffrey Wang repeatedly failed to report on forms filed with the state and with the medical school that he was receiving consulting payments, stock options and royalties from five companies on whose products he was conducting research, according to the university. The failure to report these relationships "violated university guidelines," the school said.

"UCLA regrets that in the case of Dr. Jeffrey Wang, associate professor of orthopedic surgery, a pattern of non-disclosure could have persisted without our knowledge," the school said in a statement. "We are committed to examining our processes to determine how, as an institution, we will prevent similar problems in the future." (...)

Vanskelig – men viktig – med kritisk vurdering av ny teknologi
I Norderhaug M K Gjertsen B Mørland
Tidsskr Nor Legeforen 2009; 129:1355-6 (25.6.2009)
I Tidsskriftet nr. 7/2009 stiller Bach-Gansmo & Bogsrud seg kritisk til de norske prosedyrene ved og premissene for evaluering av nytt medisinskteknisk utstyr, som positronemisjonstomografi (PET) (1). Vi er enige i at det er en utfordring å vurdere instrumenter og metoder som er i utvikling. En systematisk vurdering av forskningsbasert kunnskap er imidlertid viktig for å avklare hva vi vet om helsetjenestetiltak, også når det gjelder vurdering av PET. De fleste nye teknologier har et utviklingsforløp der nytte og risiko vurderes gjennom forskning, og PET-teknologien er i så måte ikke unik. (...)

Watching over the medical device industry
BMJ 2009;338:b2321 (23 June)
Although all new drugs have to be tested to get regulatory approval, the same is not necessarily true for medical devices. (...)

The device industry, according to several experts and external assessments, operates in a disturbingly lax regulatory environment that is riddled with conflicts of interest. As a result, the safety and efficacy of many of the highest risk devices on the market today have never been adequately tested—or tested at all. (...)

Pasienter dør av slurvefeil
vg.no 22.6.2009
Flere pasienter mister hvert år livet fordi leger og sykepleiere bruker behandlingsutstyr feil.

De siste ti årene er det meldt om nærmere 90 dødsfall knyttet til elektromedisinsk utstyr som blir brukt til behandling av pasienter. De fleste dødsfallene skjer på grunn av slurv fra leger og sykepleiere, skriver Bergens Tidende.

- Dette er selvsagt alvorlig. Slike feil bør ikke skje, sier sjefingeniør Arild Hammer i Direktoratet for samfunnstrygghet og beredskap (DSB).

Blant tabbene som gjøres, er feil innstilling av utstyr til medikamentell behandling, slik at pasientene får for store doser av legemiddelet i seg. Flere ulykker skjer også fordi utstyret blir montert feil. (...)

Senator probes Army surgeon's links to Medtronic
philly.com 19.5.2009
WASHINGTON - Sen. Charles Grassley is investigating a former Army surgeon who the Army alleges forged signatures and fabricated data in a study touting the benefits of an implant from Medtronic.

In a letter to the Walter Reed Medical Center, the Iowa Republican asks Army officials to hand over their investigation of Dr. Timothy Kuklo, who authored a paper on Medtronic's Infuse that had to be withdrawn after publication. (...)

Study of device to treat severely injured soldiers in Iraq was fake, claims army
BMJ 2009;338:b2026 (19 May)
A top surgeon has been charged by officials at Walter Reed Army Medical Center with falsifying data from a study about the efficacy of a surgical device used to treat soldiers in Iraq with blast injuries to the tibia.

He is also charged with forging the signatures of all four of his coauthors in the study (Journal of Bone and Joint Surgery 2008;90:1068-72).

The 48 year old surgeon, Timothy Kuklo, claimed a 92% success rate in treating open tibia fractures with the Infuse device, a small cage that contains protein used in the manufacture of new bone. The article, "Recombinant human bone morphogenetic protein-2 for grade III open segmental tibial fractures from combat injuries in Iraq," was retracted in March after Walter Reed notified the journal of its findings. (...)

Chemical in Medical Plastics Hard on the Heart
ivanhoe.com 6.5.2009
(Ivanhoe Newswire) – A chemical found in IV bags and catheters might be putting patients’ hearts at risk.

New research out of Johns Hopkins finds this chemical – called cyclohexanone – may be leaching out of the plastics used to make these devices and ending up in the fluids meant to help people get better when they are in the hospital. In a study involving rats, the chemical resulted in a slower pumping of less blood, weaker heart contractions, and increased fluid retention and swelling. (...)

Mystisk fejl under operationer på dansk sygehus
politiken.dk 17.4.2009
Aalborg Sygehus kan ikke finde forklaringen på, hvorfor ti operationer ikke forløb, som de skulle.

Ved ti operationer i løbet af februar var der på Aalborg Sygehus problemer med det udstyr, der sørger for, at den bedøvede patient får tilstrækkeligt med ilt under operationen. (...)

Preventing Misconnection Errors – Medical Device Safety Calendar
accessdata.fda.gov (April 2009)
FDA has received many reports of patient injuries and deaths when different device delivery systems are mistakenly connected to each other. These errors are often facilitated by fittings called Luer connectors, which allow different systems to be easily, but erroneously, connected. (...)

F.D.A. to Seek New Proof for Old Medical Devices
nytimes.com 8.4.2009
WASHINGTON — Federal regulators said Wednesday that that they would ask makers of some of the riskiest medical devices to prove that their products are safe and effective — a step that critics have said is long overdue.

In January, the Government Accountability Office issued a report scolding the Food and Drug Administration for failing for decades to fix its system for reviewing categories of devices that have been on the market since before the enactment of the medical device law in 1976. (...)

Lege dømt for tapping av virksomheten
vg.no 30.3.2009
En lege er dømt til fengsel i åtte måneder for å ha tappet legevirksomheten sin med inntil 4,1 millioner kroner.

Dommen i Haugaland tingrett slår fast at risikoen for å bli oppdaget var svært lav, og at det derfor er ekstra viktig at det ble reagert så strengt.

Legen var både styreleder og daglig leder, og har i utførelsen av disse rollene overført betydelige pengebeløp til et utenlandsk selskap som hun - og/eller hennes bror - kontrollerte, melder Økokrim.

Utad fremstod overføringene som betaling for leasing av lasermaskiner.

Legen må også tåle inndragning på 2,5 millioner kroner. (...)

Dømt for ulovlig tapping av legeklinikk
dagbladet.no 28.3.2009
(...) Haugaland tingrett har dømt en lege til åtte måneders ubetinget fengsel for å ha tappet sin egen klinikkvirksomhet for 4,1 million kroner.

Tappingen har skjedd ved at klinikkens maskinpark ble solgt til et selskap på kanaløya Guernsey og deretter leaset tilbake til klinikken.

Selskapet på Guernsey var eid av legen og hennes bror, melder Haugesunds Avis. (...)

Vurdering av ny medisinsk teknologi
Tidsskr Nor Legeforen 2009; 129:646 (26.3.2009)
T Bach-Gansmo T V Bogsrud
Prosedyrene og premissene ved evaluering av nytt medisinskteknisk utstyr ivaretar ikke helsevesenets behov, eksemplifisert ved den sene innføring av positronemisjonstomografi (PET) i Norge. (...)

Pharmaceutical, Medical Device Industries Concerned About Sharfstein as FDA Deputy Director
Kaisernetwork.org 19.3.2009
The pharmaceutical and medical device industries have praised the nomination of former New York City Health Commissioner Margaret Hamburg as FDA commissioner, but they are "nervous in varying degrees" about the nomination of Baltimore Health Commissioner Joshua Sharfstein as principal deputy commissioner of the agency, CongressDaily reports. (...)

Medtronic Links Device for Heart to 13 Deaths
nytimes.com 13.3.2009
Medtronic said Friday that at least 13 people might have died in connection with a heart device that it recalled in 2007 but was still in widespread use, including four patients whose deaths were related to efforts by doctors to surgically remove the product. (...)

Separately, a previously undisclosed Food and Drug Administration report indicates that Medtronic began receiving reports soon after the device reached the market in late 2004 that the cable, known as the Sprint Fidelis, was fracturing. The company also revised its manufacturing process in the months before withdrawing the Sprint Fidelis from the market, according to the F.D.A. report, which was provided to The New York Times by lawyers suing Medtronic. (...)

Drugs v. Devices
EDITORIAL
nytimes.com 14.3.2009
Now that the Supreme Court has ruled that patients can sue drug companies in state courts for harm caused by medicines approved by the Food and Drug Administration, Congress ought to give patients the same right to sue makers of medical devices. (...)

Crackdown on Doctors Who Take Kickbacks (Slår ned på leger som tar penger under bordet)
Nytimes.com 3.3.2009
WASHINGTON — Federal health officials and prosecutors, frustrated that they have been unable to stop illegal kickbacks to doctors from drug and device companies, are investigating doctors who take money for using these products.

For years, prosecutors rarely pursued doctors because they believed that juries would sympathize with respected clinicians. But within a few months, officials plan to file civil and criminal charges against a number of surgeons who they say demanded profitable consulting agreements from device makers in exchange for using their products. (...)

In January, Eli Lilly agreed to pay a $1.4 billion fine to settle federal criminal charges that it illegally marketed Zyprexa. (...)

Reframing relations with Pharma
Drug companies are not alone

BMJ 2009;338:b761 (24 February)
Although I agree with Godlee about pharmaceutical companies and their interaction with doctors and continuing medical education,1 they are not the only sinners. The same could just as easily be said about medical device manufacturers and their relations with clinicians—for example, about joint prostheses and orthopaedic surgeons and pacemakers and cardiologists.

If we are going to address this issue, let’s do it comprehensively, not just for drug companies. (...)

Lawmakers Seek to Return Right to Sue Device Makers
nytimes.com 19.2.2009
(...) She is considering suing the doctors, as well as the device’s maker, Medtronic, which she said bore blame for her husband’s death. But a Supreme Court decision last year stands as a barrier against suing medical device companies — an obstacle that some members of Congress want to remove. (...)

Medical Device Reviews, Criticism From Scientists Indicate Need for FDA Reform, Editorial States
kaisernetwork.org 27.1.2009
A report recently released by the Government Accountability Office that found FDA for years "has failed ... to subject some of the riskiest devices to a rigorous review mandated by Congress," as well as concerns recently raised by FDA scientists, indicates the need for reforms at the agency, a New York Times editorial states. According to the editorial, the report found that FDA continues to use a review and approval process established in 1976 for high-risk, Class III medical devices and that the process does not ensure the safety and effectiveness of the products. A group of FDA scientists also recently "complained to the Obama transition team -- and before that to Congress and to the agency's commissioner -- that during the Bush years, managers in charge of medical device reviews had corrupted and distorted the process in ways that put the public at risk," the editorial states. (...)

Top Hazards From Medical Devices in Hospitals
wsj.com 22.12.2008
Already worried about going to the hospital? If so, you probably should skip this post.

The ECRI Institute, which researches patient safety issues, issued its second annual report on the top 10 technology hazards that every hospital should pay more attention to.

Without further ado, here are the top five problems for 2008:

1. Alarm hazards
2. Needlesticks and injuries from sharps
3. Air embolisms from contrast media injectors
4. Retained devices and fragments left in patients
5. Surgical fires

Five hazards, including air embolisms from contrast injectors, make their debut this year, shouldering aside some doozies, like infusion pump programming errors and the misconnection of blood pressure monitors to IV lines.

Dan Ault, senior project engineer and manager for ECRI’s problem reporting network and author of the report, tells the Health Blog that none of the items dropped from the list have stopped being “significant concerns.” The revisions, he says, are based on the prevalence and severity of reports the group has received over the last year, recalls and other published reports. (...)

F.D.A. Scientists Accuse Agency Officials of Misconduct (FDA-forskere anklager tilsynsledere for tjenesteforsømmelse)
Nytimes.com 17.11.2008
WASHINGTON — Top federal health officials engaged in “serious misconduct” by ignoring concerns of scientists at the Food and Drug Administration and approving for sale unsafe or ineffective medical devices, the scientists have written in a letter to Congress.

“These allegations are deeply concerning,” said the committee chairman, Representative John D. Dingell, Democrat of Michigan, “and we intend to uncover whether any F.D.A. activity has compromised the health and safety of American consumers.”

Heidi Rebello, an agency spokeswoman, said, “The F.D.A. will respond directly to the committee’s concerns.”

The letter to Congress, dated Oct. 14, is part of a growing chorus of dissent from what had long been a tight-lipped agency. In decades past, scientists rarely disagreed publicly with their agency’s decisions, and any concerns they had about important decisions were whispered among veterans. (...)

US senators inquire into ties between stent makers and doctors (Amerikanske senatorer etterforsker bånd mellom stentprodusenter og leger)
BMJ 2008;337:a2363 (4 November)
Published 2008, doi:10.1136/bmj.a2363
Two US senators have asked the non-profit Cardiovascular Research Foundation and Columbia University to clarify their financial relations with manufacturers of cardiac devices such as stents.

Chuck Grassley, senior Republican member of the Senate Committee on Finance, and Herb Kohl, chairman of the Senate Special Committee on Aging, have been investigating links between the medical drug and device industry and influential doctors for several years (BMJ 2008;336:1268, 7 Jun, doi:10.1136/bmj.39598.476250.DB; 2008;336:1327, 14 Jun, doi:10.1136/bmj.39609.364688.DB; 2008;337:a929, 21 Jul, doi:10.1136/bmj.a929; 2008;337:a2088, 16 Oct, doi:10.1136/bmj.a2088; 2008;337:a2200, 21 Oct, doi:10.1136/bmj.a2200). (...)

Direct-to-Consumer Advertising of Medical Devices Under Scrutiny
JAMA 2008;300(17):1985-1986 (November 5)
The increasing use of direct-to-consumer advertising of medical devices is making some physicians and legislators uneasy.

They question whether the public can truly comprehend, based on 60-second television commercials, ad pages in newspapers and popular magazines, or Internet pages, the benefits and risks of such device-based medical interventions as a total hip replacement or the use of stents in a percutaneous coronary intervention. They also are raising questions about how the US Food and Drug Administration (FDA) will handle its regulatory role over device advertising. (...)

Hip deals put money in pocket
chicagotribune.com 26.10.2008
Partnerships between surgeons, implantmakers raise ethical concerns

The nearly 1 million Americans who will be getting an artificial hip or knee in the coming year may want to ask another question besides when they'll get back on their feet.

How much money is their orthopedic surgeon pocketing from the company making the joint implant? The answer could range from zero to more than a million dollars, in spite of a federal anti-kickback case that targeted such payments a year ago. (...)

Sens. Grassley, Kohl Ask Cardiovascular Research Foundation, Columbia University Researchers To Disclose Financial Contributions From Medical Device Makers
kaisernetwork.org 17.10.2008
Sens. Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) on Thursday sent letters to the Cardiovascular Research Foundation and Columbia University seeking financial disclosures and other information regarding their relationships with manufacturers of pharmaceutical drugs and medical devices, the New York Times reports. The lawmakers are among sponsors of legislation (HR 5605, S 2029) that would address conflict of interest issues and require disclosure of all financial ties between medical researchers, institutions and drug and device manufactures.

Grassley and Kohl in the letter asked Columbia officials to provide information about disclosures regarding financial ties to the prescription drug and medical device industries made to the university by two prominent researchers -- Martin Leon and Gregg Stone -- who have connections to the foundation. According to the Times, Leon is a former chair of CRF and Stone is its current chair. (...)

Ties Between Doctors and Stent Makers Queried
nytimes.com 16.10.2008
WASHINGTON — Heart doctors and makers of medical devices meeting for their annual convention here got a sobering piece of news on Thursday — two senators are asking tough questions about financial ties between the doctors and the companies.

The two lawmakers, Charles E. Grassley, Republican of Iowa, and Herb Kohl, Democrat of Wisconsin, sent a letter asking the nonprofit group that sponsors the conference, the Cardiovascular Research Foundation, for information about its financial relationships with device manufacturers and drug producers. (...)

Lawmakers ask about doc payments from device industry
modernhealthcare.com 16.10.2008
Sens. Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) sent inquiries to Columbia University and to the Cardiovascular Research Foundation to determine whether research physicians affiliated with the institutions received money from the medical-device industry.

Letters sent to both institutions are specifically seeking information about the foundation’s support for an annual conference promoting cardiac devices and techniques, plus the additional financial relationships between professors of medicine and cardiac-device companies featured at this conference. (...)

Suit says Meditronic gave doctors plush gifts
fiercehealthcare.com 25.9.2008
Apparently, Medtronic really loves surgeons--so much so that it gave them lots of presents. The medical devicemaker allegedly gave doctors some very plush gifts for using its products, including sexy entertainment, trips to Alaska and patent royalties for inventions in which they had no part, according a lawsuit brought by a former Medtronic lawyer.

The suit targets not only Medtronic, but also 10 doctors, including surgeon Jeffrey Wang, now director of the University of California at Los Angeles's Comprehensive Spine Center.

The allegations are focused on Medtronic's spinal-devices unit, which has $3 billion in annual revenue. Among other things, the suit contends that the unit had sham consulting agreements with more than 100 surgeons who were strictly vehicles to funnel payoffs to them in exchange for their using the unit's products. Medtronic had previously agreed to pay $40 million to the federal government to settle related allegations. (...)

More MRIs may reignite debate
startribune.com 26.7.2008
As regulators track the rapid growth of medical imaging facilities, a new center with high-profile partners opens in Edina. (...)

Its opening is likely to reignite a debate on whether Minnesota has too many diagnostic imaging facilities, encouraging doctors to order unnecessary procedures and pushing up medical costs. It's also likely to raise the ethically thorny question of whether doctors should refer patients to a facility in which they have a financial stake. (...)

Tracking and identification tags can interfere with critical devices in hospitals
BMJ 2008;337:a584 (Published 4 July 2008)
JAMA2008;299:2884-90
Dutch researchers have uncovered a new threat in an already hazardous healthcare environment—malfunction of medical devices caused by tracking tags that use radiofrequency identification technology. The technology, which is already used in security access cards and antitheft tags on clothes, can be used in hospitals to tag and track expensive equipment, identify drugs to prevent counterfeiting, and monitor the quality of blood products, among other things. (...)

Medical-Device Safety and the FDA
NEJM 2008;359:88-89 (July 3)
To the Editor: In his Perspective article, Maisel (March 6 issue)1 criticizes the response of the Food and Drug Administration (FDA) to adverse events preceding the recall of Medtronic's Sprint Fidelis implantable cardioverter–defibrillator (ICD) leads. The FDA agrees with Maisel's premise that physicians and patients should receive accurate and timely information about problems with marketed medical devices. (...)

Why Doctors Should Worry about Preemption
NEJM 2008;359: 1-3 (July 3)
A leading drug company may be poised to win a landmark legal victory next fall. If the drug manufacturer, Wyeth, prevails in a case soon to be argued before the U.S. Supreme Court (Wyeth v. Levine),1 drug companies could effectively be immunized against state-level tort litigation if their products that have been approved by the Food and Drug Administration (FDA) are later found to be defective. (...)

Implant firms pay doctors millions (Implantatfirmaer betaler leger millioner)
philly.com 29.6.2008
As joint replacements have increased, so have payments to surgeons.
First of two articles.

In the past decade, hip- and knee-replacement surgery has exploded - nearly doubling to about 750,000 operations a year and fueling a multibillion-dollar implant industry with profit margins approaching 20 percent.

With so much money in play, competition among artificial hip and knee manufacturers has fostered a system of five-, six- and seven-figure payments to doctors in royalties, consulting deals and speaking fees.

Those financial arrangements, long an open secret in the medical community, have now come under intense scrutiny from federal prosecutors and members of Congress - who are considering legislation requiring disclosure.

Critics question whether the payments can present a conflict of interest by skewing doctors' judgments on how best to treat their patients. At the same time, some concede that payments to pioneering surgeons who help design and patent artificial joints and other medical devices are legitimate.

Federal investigators who have examined the deals have in some cases found large consulting fees paid to doctors for little or no work, lavish trips disguised as medical seminars, and direct payments to surgeons that seemed aimed at convincing them to use a company's products.

Last year, a U.S. attorney in New Jersey filed criminal complaints alleging that four of the largest artificial-joint makers conspired to violate a federal anti-kickback statute by making payments to surgeons as inducements to use their medical devices. (...)

FDA Finds Many Possibly Life-Threatening Medical Equipment Malfunctions Result From Software Problems (FDA oppdager mange mulige livstruende tekniske feil som skyldes software problemer)
kaisernetwork.org 30.6.2008
The Baltimore Sun on Monday examined how FDA, with help from experts in the information technology and scientific fields, has found that medical equipment "might not malfunction because it was poorly designed or badly made ... but because the computer code running it includes a mistake."

According to the Sun, the "impact of that glitch can be increasingly serious because the latest automation is removing the doctors and nurses who watched for machine mix-ups" in the past. FDA in 2004 created a forensic software department to address the increased number of medical equipment recalls related to software problems. The department includes 10 mathematicians, computer scientists and a physicist who previously designed military satellites. In 2007, 23 of the medical equipment recalls that FDA considered life-threatening involved software problems. (...)

Flaws in medical coding can kill (Feil i medisinsk koding kan ta liv)
baltimoresun.com 30.6.2008
Spread of computers creates new dangers, FDA officials warn

WASHINGTON - After a routine piece of medical equipment started mysteriously killing hospital patients a few years ago, the federal government turned to a small team of its software experts in suburban Maryland for help.

The team's discovery - a flaw in a computer code that caused a drug pump to administer heavy overdoses - led to a recall, warnings and rewriting of the equipment's software. The discovery also illustrated a new threat behind some lifesaving medical devices. (...)

FDA Plans Near-Instantaneous Sentinel for Safety of Drugs and Devices
medpagetoday.com 22.5.2008
WASHINGTON, May 22 -- The FDA revealed plans today to develop a system that will allow nearly real-time monitoring of drug and device safety.

The so-called Sentinel initiative will permit "proactive surveillance of medical products on the market," Mike Leavitt, the secretary of Health and Human Services, said at a press conference.

The initiative is a response to last year's Food and Drug Administration Amendments Act, which called for active post-market surveillance of medical products. (...)

Group Urges Ban on Medical Giveaways (Gruppe ber om forbud mot medisinske gaver)
nytimes.com 28.4.2008
Drug and medical device companies should be banned from offering free food, gifts, travel and ghost-writing services to doctors, staff members and students in all 129 of the nation’s medical colleges, an influential college association has concluded.

The proposed ban is the result of a two-year effort by the group, the Association of American Medical Colleges, to create a model policy governing interactions between the schools and industry. While schools can ignore the association’s advice, most follow its recommendations. (...)

New Focus of Inquiry Into Bribes: Doctors (Ny fokus på granskning av bestikkelser: Leger)
nytimes.com 22.3.2008
A long-running federal investigation into the orthopedic device industry’s suspected kickback payments to hip and knee surgeons now has the doctors in the spotlight.

Having reached settlements with the five leading makers of artificial joints last year over the payments, the government has been focusing on the many doctors who receive money as the companies’ paid consultants.

“We are going to be looking at those soliciting kickbacks,” Lewis Morris, the chief counsel in the federal office that pursues civil complaints of Medicare fraud, told an audience of hundreds of doctors, company representatives and investors this month in San Francisco at the annual meeting of the American Academy of Orthopedic Surgeons. (...)

Dr. Coon declined to say how much he was owed after Zimmer halted payments in October. Zimmer’s disclosure said it paid him $158,420 last year — in addition to $1,944 for air travel, $2,498 for lodging, $1,034 for meals, $440 for ground transportation and $10 for a gift. (...)

Medical Device Industry Spent More Than $28M on Lobbying Federal Government in 2007, Analysis Finds
kaisernetwork.org 21.3.2008
Medical device companies in 2007 spent more than $28 million on lobbying the federal government, compared with $26.5 million in 2006, according to a preliminary analysis of U.S. Senate records conducted by the Center for Responsive Politics, the St. Paul Pioneer Press reports. In 2007, medical device companies lobbied Congress on an FDA reform bill, Medicare legislation, a bill that would require companies to disclose payments to physician consultants and legislation that would encourage health insurers to cover remote monitoring devices. (...)

Patients Deserve More Information On Potentially Faulty Devices – Maisel (Pasienter fortjener mer informasjon om mulig defekt utstyr - Maisel)
medicaldevicestoday.com 10.3.2008
A leading expert on medical device safety wants Congress to compel FDA and manufacturers to provide more consumer protections for patients with implanted devices.

"The welfare of medical device recipients must become a higher priority for the FDA and manufacturers, and it is increasingly apparent that such a change will require Congressional action," William Maisel, M.D., argues in an editorial in the March 6 New England Journal of Medicine. (...)

Semper Fidelis — Consumer Protection for Patients with Implanted Medical Devices (Semper Fidelis - Forbrukerbeskyttelse for pasienter med implantert medisinsk utstyr)
NEJM 2008;358:985-987 (March 6, 2008)
When the Food and Drug Administration (FDA) approved the Medtronic Sprint Fidelis implantable cardioverter–defibrillator (ICD) lead in 2004 on the basis of bench testing but no human clinical data, there was no public outcry. Physicians rapidly incorporated the new electrode into their practice, welcoming its small diameter and ease of implantation. During the ensuing 3 years, 90% of Medtronic ICDs were implanted with this lead (see diagram). But in October 2007, after 38 months on the U.S. market and 268,000 implantations worldwide, the Fidelis was voluntarily recalled by Medtronic because of its propensity to fracture. The large number of affected patients, the billions of dollars at stake in the ICD market, and the controversy surrounding the timing of communication with physicians and patients about the lead's performance highlight the shortcomings of the regulatory system for medical devices and underscore the urgent need for legislation that will ensure adequate protection for the patients receiving them. (...)

Senate Panel to Question
online.wsj.com 27.2.2008
Payments to Surgeons

Five makers of orthopedic implants paid more than $221 million to surgeon "consultants" in 2007, according to a U.S. Senate committee that plans to question the payments at a hearing today.

The companies -- Zimmer Holdings Inc. and Biomet Inc. of Warsaw, Ind.; Stryker Corp. of Kalamazoo, Mich.; Smith & Nephew PLC of London, and the DePuy Orthopaedics unit of Johnson & Johnson, New Brunswick, N.J. -- agreed to disclose the payments in September in settling government allegations that they violated antikickback laws by paying physicians to use their products exclusively.

Four of the companies -- all but Stryker -- also agreed to pay $310 million to settle claims that the payments were, in reality, rewards to doctors who selected a company's hip and knee implants, even when they weren't necessarily the best for a particular patient. Stryker agreed to government supervision but didn't make a payment. The companies didn't admit any wrongdoing. (...)

Senate panel probes medical device companies (Senatet gransker medisinske utstyrsfirmaer)
reuters.com 26.2.2008
WASHINGTON (Reuters) - Medical device companies will come under scrutiny on Wednesday when a U.S. Senate committee probes financial payments to doctors which some say are aimed at creating loyalty for products like artificial hips and knees.

The U.S. Senate Special Committee on Aging will discuss gifts, royalties and other financial enticements made to doctors and surgeons from medical device makers, and consider legislation requiring the companies to disclose the incentives on the Internet.

According to a report prepared for the committee hearing, Zimmer Holding made $86 million in direct payments to doctors in 2007, while Stryker Corp made at least $40 million in such payments. Both companies are major makers of artificial hips and knees.

The figures may underestimate the payments because of delays in reporting. Sen. Herb Kohl, the Wisconsin Democrat who heads the aging panel, said he will release full results from the six-month investigation into the payments at the hearing. (...)

For F.D.A., a Major Backlog Overseas
nytimes.com 29.1.2008
WASHINGTON — The Food and Drug Administration is so understaffed that, at its current pace, the agency would need at least 27 years to inspect every foreign medical device plant that exports to the United States, 13 years to check every foreign drug plant and 1,900 years to examine every foreign food plant, according to government investigators.

Computer systems at the drug agency are so inadequate that it can only guess the number of the plants, and it cannot produce a list of those that have not been inspected. The situation is particularly dire in China, which has more drug and device plants than any other foreign nation but where F.D.A. inspections are few.

These findings come from a series of reports by the Government Accountability Office — obtained by The New York Times — scheduled to be released Tuesday at a hearing of the House Energy and Commerce Committee. (...)

Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections. GAO-08-428T, January 29
gao.gov 29.1.2007
(...) The small number of inspections completed to date by accredited third-party organizations raises questions about the practicality and effectiveness of establishing similar programs that rely on third parties to quickly help FDA fulfill its responsibilities. (...)

FDA Cannot Meet Requirements for Inspections of Medical Device Manufacturing Facilities, GAO Report Finds
kaisernetwork.org 29.1.2008
Prescription Drugs

FDA cannot meet requirements for inspections of medical device manufacturing facilities in the U.S. and abroad, according to a Government Accountability Office report scheduled for release on Tuesday at a hearing of the House Energy and Commerce Oversight and Investigations Subcommittee, the Wall Street Journal reports (Wilde Mathews, Wall Street Journal, 1/29).

The report found that inspections of all medical device manufacturing facilities abroad would take FDA 27 years. FDA computer systems cannot determine the number of medical device manufacturing facilities abroad that export products to the U.S. or which facilities the agency has inspected, the report found (Harris, New York Times, 1/29). According to the report, FDA inspects U.S. facilities that manufacture the highest-risk medical devices once every three years and facilities that manufacture moderate-risk medical devices once every five years. "Both are supposed to be looked at every two years," the Journal reports. (...)

Varierande kunskap om medicintekniskt regelverk
lakemedelsverket.se 28.1.2008
Tillverkare av medicintekniska produkter har mycket varierande kunskap om de krav som ställs på deras produkter. Det visar en kontroll som Läkemedelsverket nyligen genomfört.

Läkemedelverket har gjort en marknadskontroll av ett antal medicintekniska företag för att se vilken kunskap de har om regelverket kring sina produkter. Granskningen visade på stora variationer mellan olika företag, medan medelnivån på kunskapen var acceptabel. Generellt var kunskapen större hos de stora internationella företagen. (...)

Mandatory disclosure of trial results for drugs and devices
Editorials
BMJ 2008;336:170 (26 January)
New US law will require public posting of all the main results and data on harms (...)

"For Cause" Inspections Find Galloping Clinical Trial Violation Rate
medicaldevicestoday.com 7.1.2008
This article is reprinted from "The Gray Sheet" – January 7, 2008
The violation rate for clinical trial sponsors shot up in fiscal year 2007, hitting a 10-year high, with FDA finding many of the problems during inspections triggered by complaints, according to CDRH.

Of the 40 trial sponsors inspected by the device center's division of bioresearch monitoring (BIMO) last year, 33% were classified by FDA as "official action indicated" (OAI), denoting that significant regulatory violations were found. That compares with 11% of the 53 sponsors inspected in fiscal 2006 that were significantly out of compliance, the best industry performance in 10 years.
Device companies were the target of eight BIMO warning letters in 2007, five more than in 2006. (...)

Kirurger i USA fikk betalt for å bruke leddproteser
Tidsskr Nor Lægeforen 2008; 128: 74-6 (3.1.2008)
Fem amerikanske utstyrsprodusenter har innrømmet å ha betalt ortopediske kirurger penger for at de skulle benytte visse hofte- og kneproteser. Selskapene har inngått forlik med myndighetene, der fire av dem må betale til sammen 311 millioner amerikanske dollar i bot. Det er fortsatt uklart om enkeltkirurger vil bli straffet.

Det er forbudt for firmaer å betale enkeltindivider for å bruke deres produkter (kickback). Etterforskningen viste at det i perioden 2002 - 06 var vanlig å betale enkeltkirurger «konsultasjonshonorarer» på opptil flere hundre tusen dollar i året, ofte kombinert med utenlandsreiser og andre godtgjørelser. De fem selskapene, som står for nesten 95 % av det amerikanske markedet, har forpliktet seg til å endre praksis, bedre opplæringen av sine ansatte og bli overvåket av offentlige myndigheter i 18 måneder. Med dette forliket unngår de å bli ekskludert fra Medicare, som betaler for helsetjenester, inkludert leddkirurgi, til svært mange eldre. Saken ble bredt omtalt av amerikanske medier for flere år siden, og forliket er nylig omtalt i BMJ (1).

En nettside om forskningsetikk har lagt ut navnene til om lag 50 kirurger som har mottatt mer enn 1 million amerikanske dollar hver (2). På nettsiden til American Academy of Orthopedic Surgeons understreker organisasjonens president at det må være full åpenhet om legers interessekonflikter og finansielle bindinger til utstyrsprodusenter, men at pengeoverføringer oftest er honorar for konsulentarbeid, forskning eller opplæringsvirksomhet (3). (...)

Hjertestødere redder liv – men ødelægger livskvalitet
berlingske.dk 14.12.2007
(...) 3000 danskere har en hjertestøder, der minimerer risikoen for at dø af hjertestop. Men det livreddende stød er så smertefuldt, at patienterne lever i frygt. 30 procent af dem har tegn på depression efter et år med hjertestøder. (...)

Frykter sentralisert innkjøpsmakt
helserevyen.no 3.12.2007
Helseforetakene og NAV har fått så stor innkjøpsmakt at de kan utradere store deler av en bransje når de velger én leverandør. (...)

- Ingen fare
- Vi er klar over faren, men den er ikke reell, sier adm. direktør Terje Skansen i Helseforetakenes innkjøpskontor (HINAS), som er eid av de fire regionale helseforetakene.

HINAS har oppnådd rundt 200 millioner kroner i rabatter siden det ble etablert i 2002.

Skansen mener bransjen må finne seg i at noen faller fra og andre kommer til.

- Du kan være sikker på at når det lyses ut en ny stor kontrakt, så er de internasjonale produsentene raske til å etablere et apparat her, sier han.

Helseforetakene kjøper inn for 20 milliarder kroner hvert år, 4-5 milliarder av dette er medisinsk utstyr. (...)

New FDA Center Rife With Risks
forbes.com 14.10.2007
WASHINGTON - The Food and Drug Administration is moving with unprecedented speed to launch a drug research center to be paid for by companies it regulates.

The goal of the Reagan-Udall Foundation, approved by Congress and signed into law late last month, is to streamline and improve the development of drugs and medical devices, a goal long sought by regulators and the biggest players in the industry, such as Merck & Co., Pfizer Inc., Wyeth, GlaxoSmithKline PLC, and Johnson & Johnson. (...)

Open Clinical Trials
Published at www.nejm.org October 3, 2007 (10.1056/NEJMe0706501)
On September 27, 2007, President Bush signed into law the Food and Drug Administration Revitalization Act, which aims to improve the FDA's ability to ensure the safety of the nation's drugs and medical devices. The legislation not only reauthorizes the user-fee mechanism that has been part of the agency's funding since 1992, but also increases the agency's overall financial resources. Although the user-fee approach to funding has been controversial because the fees are paid by the pharmaceutical industry, which the FDA is charged with regulating, legislators believed that user fees provide a stable monetary base that is crucial to the effectiveness of the agency. (...)

Medtronic, Again Questioned Over Payments to Doctors, Is Subject of Senator’s Inquiry
nytimes.com 27.9.2007
An influential senator is raising new questions about payments made to spine surgeons by Medtronic, one of the nation’s largest makers of medical devices.

Medtronic, which reached a $40 million settlement last year with the federal government over accusations that the company had paid illegal kickbacks to doctors for using its spinal devices, has continued to pay doctors millions of dollars in consulting fees, according to a lawyer representing a whistle-blower involved in the case.

Senator Charles E. Grassley, Republican of Iowa, has written to Medtronic, asking the company to explain, among other things, any payments made since the period covered by the settlement. The letter is part of a broad inquiry by Mr. Grassley into the financial ties that often exist between doctors and the companies that make medical devices and drugs. (...)

Nytt norsk løftesystem for helsetjenesten
helserevyen.no 19.9.2007
En ny type personløfter skal avlaste slitne rygger i helsetjenesten. Personløfteren Molift Nomad, som kan løfte flere hundre kilo, er valgt til Månedens produkt i design-og-arkitektursenteret (DogA) i oktober. (...)

Dataimplantat kobles til kreft
helserevyen.no 12.9.2007
Implantater med sporingsteknologi basert på radiobølger utviklet for å redde liv, kan vise seg å være kreftfremkallende. (...)

Implantatet består av en RFID-brikke (Radio Frequency Identification) med informasjon om pasientens sykdomshistorie, og er til nå operert inn i kroppen hos rundt 2000 personer verden over.

RFID-brikken fra Verichip ble i 2005 kåret til en av årets mest innovative teknologier, og ble tidlig godkjent av de amerikanske mat- og medisinmyndighetene for implantering i mennesker. Brikken skulle nemlig kunne redde liv ved at leger fikk rask tilgang til en pasients sykdomshistorie gjennom skanning av brikken. (...)

Elektrisk instrument begynte å brenne inne i pasientens kropp
vg.no 16.8.2007
BERGEN (VG) Pasienten lå på operasjonsbordet da det elektrokirurgiske apparatet begynte å brenne ukontrollert, inne i kvinnens kropp. (...)

Pasienter får millionregning
nrk.no 15.3.2007
Mange pasienter må bruke maskiner for å holde seg i live. De må selv ta regningen med å forsikre maskinene, en regning på mange hundre millioner kr. (...)

95.000 låner medisinsk utstyr
For å kunne bo hjemme, har funksjonshemmede som Hilde Andersen hjelpere og avanserte hjelpemidler. (...)

Medisinsk utstyr tok livet av seks personer i fjor
vg.no 8.3.2007
Seks personer døde i fjor på grunn av svikt eller feil bruk av medisinsk teknisk utstyr, viser tall fra Direktoratet for samfunnssikkerhet og beredskap (DSB).

Til sammen fikk DSB 141 meldinger om uhell, ulykker og nestenulykker i forbindelse med bruk av medisinsk teknisk utstyr i fjor. Seks av hendelsene førte til dødsfall, mens 45 andre endte med at pasienter ble skadd. (...)

- Sykehusene sliter med elektromedisinsk utstyr som burde vært skiftet ut, sier Siri Tau Ursin, leder av Overlegeforeningen og sentralstyret i Legeforeningen, til Dagsavisen. (...)

FDA seeks to better track medicines, devices
startribune.com 12.1.2007
The agency plans to create a network to spot safety risks in drugs and medical devices after they reach consumers. (...)

Fortsatt miljøgift i medisinsk utstyr
dagsavisen.no 19.12.2006
Fra nyttår blir det forbudt å selge leker med ftalater. Likevel kan det drøye før de kjemiske stoffene blir fjernet fra medisinsk utstyr. (...)

Weitz & Luxenberg Responds to Report of Panelists' Financial Ties to Stents
genengnews.com 11.12.2006
As the Food and Drug Administration panel converged last week in Washington to review the incidence of lethal blood clots linked to drug-eluting stents, a Bloomberg News article revealed that six physicians who have been advising U.S. regulators on the matter, have financial ties to Johnson & Johnson, maker of the Cypher (Cordis) Stent, and Boston Scientific Corp., maker of the Taxus Express(2) Paclitaxel-Eluting Coronary Stent. The panel has just recommended allowing those dangerous products to remain on the market.

Of today's FDA decision, Paul J. Pennock, director of the drug and medical device litigation unit at Weitz & Luxenberg, P.C., said, "It is unsurprising that the Panel would vote in favor of the stents despite the strong evidence that drug-eluting stents carry life-threatening risks." (...)

FDA warns of stent complications
WASHINGTON — New drug-oozing stents widely used to prop open clogged arteries are associated with an increased risk of blood clots, heart attacks and death for the majority of patients receiving the devices, an expert panel concluded Friday. (...)

Pasientregister kan redde liv
tv2.no 28.11.2006
Helse- og omsorgsdepartementet ønsker å opprette et pasientregister for å fange opp feil ved utstyr ved norske sykehus.

Flere pasienter opplever livsfarlige bivirkninger over helt nytt medisinsk utstyr. Helse- og omsorgsdepartementet ønsker å opprette et pasientregister for å fange opp feil ved utstyr ved norske sykehus. Men Datatilsynet er kritisk til et register som følger pasientenes sykdomshistorie, melder TV 2 Nyhetene.
Et bredt utvalg av norske leger mener et slikt register kan redde liv.

- Pasientene er trygge og kan være forsikret om at den informasjonen som blir lagret om dem ikke blir misbrukt og kun vil være tilgjengelig for et fåtall personer. Den informasjonen vi kan få fra registeret vil kunne bidra til å redde liv, sier John-Arne Røttingen, direktør for Nasjonalt kunnskapssenter for helsetjenesten, til TV 2 Nyhetene. (...)

Sjukhus dåliga på att rapportera farliga produkter
netdoktor.passagen.se 15.11.2006
Sjukhus är skyldiga att rapportera fel på medicinska produkter men detta
görs endast i mycket liten utsträckning. Det uppger Läkemedelsverket som får
in rapporter om fel från tillverkarna. Antalet rapporter från just
tillverkarna har ökat med tre gånger under perioden 2002 till 2006 medan
antalet rapporter från sjukvården under samma period har minskat. Arne
Kardell vid läkemedelsverket tror att det kan bero på att vårdpersonalen
inte hinner, inte vet hur anmälan ska fyllas i eller inte vet att de är
skyldiga att göra en anmälan. De vanligaste felrapporterna som
Läkemedelsverket får gäller hjälpmedel som rullstolar, rollatorer och
patientliftar. (...)

FDA Announces Plans To Impose Stricter Medical Device Safety Standards
medicalnewstoday.com 12.11.2006
FDA on Thursday released recommendations for improving post-market surveillance of medical devices, the AP/Los Angeles Times reports. Safety concerns for post-market monitoring of medical devices "grew after last year's slew of high-profile recalls or safety warnings affecting more than 200,000 defibrillators," according to the AP/Times (AP/Los Angeles Times, 11/10). (...)

FDA may change handling of safety issues
yahoo.com 9.11.2006
The Food and Drug Administration plans to revamp how it handles safety issues with the stents, pacemakers, implantable defibrillators and other medical devices it regulates.

As it does so, it plans to utilize data-mining techniques that could give the agency early warning of potential problems. (...)

New Nerve Test, a Moneymaker, Divides Doctors
nytimes.com 20.10.2006
SIDE EFFECTS
For many doctors, it’s an irresistible pitch: a $250 profit from a 15-minute test.
With that lure, some 12,000 of the nation’s physicians have purchased an automated device that checks patients for nerve disease. Such a diagnosis might otherwise require extensive testing by specialists. (...)

One neurologist cites an extreme case, in which a general practitioner diagnosed arm numbness as carpal tunnel syndrome but missed the main cause: a brain tumor. (...)

Krever gransking av «drittpakke»
helserevyen.no 17.10.2006
Aksjon forsvar Lærdal sykehus krever at Helse Vest blir gransket for bevisst planting av en «drittpakke» for å stoppe foretaksmøtet om Lærdal sykehus i september.

Det går fram av en e-post Aksjon forsvar Lærdal har sendt til helse- og omsorgsminister Sylvia Brustad etter at Helse Vest i går offentliggjorde en rapport fra revisorfirmaet Deloitte som viser at Lærdal sjukehus (Helse Førde) har gjort innkjøp som både er på kant med loven om offentlige innkjøp, etiske retningslinjer og interne retningslinjer. (...)

Revisor fant lovbrudd i Lærdal-saken
helserevyen.no 16.10.2006
Revisor har nå slått fast at ortopediklinikken ved Lærdal sjukehus i Helse Førde har gjort innkjøp som både er på kant med loven om offentlige innkjøp, etiske retningslinjer og interne retningslinjer. (...)

Lærdal-ortopedien hadde unntak
helserevyen.no 2.10.2006
Ortopediklinikken i Lærdal var ikke forpliktet til å følge den innkjøpsavtalen Helse Vest har beskyldt klinikken for å ha brutt.

Saken om Helse Vests gransking av Ortopediklinikken i Lærdal, og overlege Truls Jellestad, er kommet i et underlig lys etter at NRK Sogn og Fjordane i dag har avdekket at Helse Førde ikke har tiltrådt den avtalen klinikken er beskyldt for å ha brutt.

Det viser seg nemlig at Ortopediklinikken i Lærdal var unntatt fra innkjøpsavtalen i Helse Vest om innkjøp av ortopedisk utstyr inntil Helse Førde eventuelt ville tiltre i løpet av avtaleperioden. (...)

Physicians push FDA to drop recall use
yahoo.com 28.9.2006
WASHINGTON - The Food and Drug Administration is considering not using the word "recall" to warn patients and doctors about defective pacemakers and defibrillators at the request of a physicians' group struggling to deal with a loss of public confidence in the safety of implantable heart devices.

FDA officials say they are conducting focus groups to see whether the currently used "recall" term is causing undue alarm when used to refer to heart devices the agency has decided might be faulty. (...)

Lege granskes for innkjøp
aftenposten.no 28.9.2006
Legen i Lærdal skal ha handlet utstyr helt utenom offisielle avtaler og regelverk.

Nå settes det i gang en omfattende granskning av saken. Den anerkjente ortopeden i Lærdal har over lang tid kjøpt utstyr til operasjoner, proteser og annet ortopedisk utstyr fra en og samme leverandør. (...)

Uten avtale
Dette er en leverandør som ikke har avtale med Helse Vest. Dermed er reglene for anskaffelser brutt. Samtidig skal legen etter det Aftenposten erfarer ha mottatt gratis utstyr fra leverandøren. Det skal blant annet dreie seg om PC-utstyr. Om utstyret bare har vært brukt på sykehuset, eller om legen også har hatt glede av dette i privat sammenheng, er ikke kjent foreløpig. (...)

The Price of Growth in the Medical-Device Industry
New England Journal of Medicine is owned 2006;355:337-339 (July 27)
In one of the most dramatic corporate acquisitions in recent memory, Boston Scientific, a large manufacturer of medical devices, outbid industry giant Johnson & Johnson to purchase Guidant Corporation earlier this year. Joining Boston Scientific in this effort was Abbott Laboratories, which paid $5 billion for Guidant's endovascular-device business. The outcome could hardly have been anticipated when Johnson & Johnson agreed to purchase Guidant for $25 billion in December 2004. In the wake of disclosures of lawsuits over allegedly defective Guidant devices, Guidant agreed to reduce the purchase price to $21.5 billion. Then Boston Scientific stepped in with a higher... [Full Text of this Article]

Life threatening Malfunction of Implantable Cardiac Devices
The New England Journal of Medicine (NEJM) 2006;354:2309-2311 (June 1)
During the summer of 2005, in the wake of widespread criticism of its failure to communicate the potentially fatal malfunctions of its implantable defibrillators,1,2 Guidant Corporation created an independent panel, of which we were members. The purpose of the panel was to conduct an unbiased examination of these incidents, including the methods used to identify the malfunctions and evaluate products in the post-marketing phase and the policies regarding communication within the corporation and with physicians and patients. The panel was also asked to recommend corrective actions. Concurrently, the Heart Rhythm Society — which represents physicians who implant . . . [Full Text of this Article]

Doctors Urge Safety Panels for Devices
nytimes.com 27.4.2006
A major medical group called yesterday for sweeping changes in how the medical device industry and the government oversee implanted heart devices, and urged companies to use outside experts to help them decide when to issue alerts about potential safety problems in products. (...)

"Manufacturers are in the best position to evaluate their own devices," the medical group wrote in its report yesterday. "However, a concern with this system is that the evaluation of the devices and the recommendations for actions by those within the company involves an inherent conflict of interest that could affect the outcome." (...)

F.D.A. Plans to Intensify Oversight of Heart Devices
nytimes.com 7.4.2006
The Food and Drug Administration plans to strengthen how it monitors critical heart devices like defibrillators by appointing outside medical experts to help it review the safety of units already on the market, a top agency official says. (...)

Surgical Device Poses a Rare but Serious Peril
nytimes.com 17.3.2006
A burn (circled) from an insulation failure on an electrical instrument. (...)

"It wouldn't surprise me in the least if it caused more than 100 deaths and 10,000 injuries annually," said Dr. Alan Johns, a Fort Worth gynecologist who frequently teaches courses on the complications of laparoscopy.

No one has precise data, because the physical evidence of the initial burn is often destroyed in the effort to save patients when infections or other symptoms become apparent days or weeks later, and by then the surgical tools have been discarded or cleaned for reuse. What's more, hospitals are under no obligation to look for evidence of such burns or report the details of such cases.

Safety advocates say the risk of burns can be reduced by relatively inexpensive scanning devices that can be used before surgery to test electrical wands for insulation cracks. Moreover, the risk can be virtually eliminated by using wands with monitoring systems that shut them down instantly if power is leaking.

New doubts about devices (Ny tvil om utstyr)
EDITORIAL
latimes.com 21.2.2006
FOR DECADES, PHARMACEUTICAL companies have lavished gifts on doctors, including meals, sports tickets and extravagant trips billed as "educational seminars." Now there's growing evidence that such graft, to use the term in its nonmedical sense, is migrating to the fast-growing medical device industry. (FOR DECADES, PHARMACEUTICAL companies have lavished gifts on doctors, including meals, sports tickets and extravagant trips billed as "educational seminars." Now there's growing evidence that such graft, to use the term in its nonmedical sense, is migrating to the fast-growing medical device industry.)

Earlier this month, the renowned Cleveland Clinic announced tighter conflict-of-interest rules after a hospital investigation found that its chief executive had a financial relationship with a medical device firm that sold products used in a type of surgery the hospital has advocated. Last month, it was revealed that a former employee at industry giant Medtronic Inc. has filed a whistle-blower lawsuit alleging that the company improperly paid millions of dollars to dozens of surgeons across the country, possibly encouraging them to perform unnecessary surgeries. (One doctor allegedly received $400,000 for eight days of work a year.) (Earlier this month, the renowned Cleveland Clinic announced tighter conflict-of-interest rules after a hospital investigation found that its chief executive had a financial relationship with a medical device firm that sold products used in a type of surgery the hospital has advocated. Last month, it was revealed that a former employee at industry giant Medtronic Inc. has filed a whistle-blower lawsuit alleging that the company improperly paid millions of dollars to dozens of surgeons across the country, possibly encouraging them to perform unnecessary surgeries. (One doctor allegedly received $400,000 for eight days of work a year.)

Another worrisome trend: surgeons who own their own medical device companies, which then sell to hospitals where the surgeons work. The practice may be legal, but California's attorney general has started an investigation into the issue. (Another worrisome trend: surgeons who own their own medical device companies, which then sell to hospitals where the surgeons work. The practice may be legal, but California's attorney general has started an investigation into the issue.)

At best, questionable financial relationships such as these dilute the public's faith in doctors. At worst, they may be putting patients' lives at risk. (At best, questionable financial relationships such as these dilute the public's faith in doctors. At worst, they may be putting patients' lives at risk.)

Since last year, Guidant Corp. has recalled or issued safety advisories for nearly 88,000 defibrillators and more than 200,000 pacemakers. At least seven deaths have been linked to faulty devices, and company executives evidently knew of problems long before they disclosed them to physicians. The company has used financial incentives to sell its products to doctors; surely those who've taken advantage of those incentives without asking too many questions deserve some scrutiny, if not blame. (Since last year, Guidant Corp. has recalled or issued safety advisories for nearly 88,000 defibrillators and more than 200,000 pacemakers. At least seven deaths have been linked to faulty devices, and company executives evidently knew of problems long before they disclosed them to physicians. The company has used financial incentives to sell its products to doctors; surely those who've taken advantage of those incentives without asking too many questions deserve some scrutiny, if not blame.)

Like the pharmaceutical industry before it, the medical device industry has agreed to a voluntary code of ethics that bans most industry gifts to doctors. But voluntary guidelines aren't enough, and few companies are paying attention. As baby boomers age, the industry is set for a huge financial windfall. For their own good as well as that of their patients, doctors and manufacturers must clean up their act. (Like the pharmaceutical industry before it, the medical device industry has agreed to a voluntary code of ethics that bans most industry gifts to doctors. But voluntary guidelines aren't enough, and few companies are paying attention. As baby boomers age, the industry is set for a huge financial windfall. For their own good as well as that of their patients, doctors and manufacturers must clean up their act.)

Ti personer døde som følge av svikt i sykeutstyr
aftenposten.no 2.2.2006
Ti personer døde i fjor i forbindelse med teknisk svikt eller svikt i bruken av elektromedisinsk utstyr, viser en oversikt fra Direktoratet for samfunnssikkerhet og beredskap (DSB).

I fem av de ti tilfellene med dødelig utgang var det mangelfull kjennskap til bruk av det tekniske utstyret hos klinikere og ambulansepersonell som førte til dødsfallene. Med ett unntak dreide det seg om hjertestartmaskiner eller defibrillatorer, opplyser avdelingsdirektør Arild Hammer i DSB.

I de resterende fem tilfellene var det teknisk svikt i to tilfeller og ukjent årsak i tre tilfeller bak dødsfallene.

- Det burde ikke forekomme slike ulykker, ulykkestallet burde vært ned mot null. Her er det snakk om folk som skal på sykehus for å bli friske og som i stedet får en slik skjebne. Det verste synes jeg er de tilfellene der brukerne ikke behersker utstyret, og denne mangelen på kunnskap hos brukerne av utstyret overrasker oss. Det er jo laget så mange og sterke rutiner at slike ulykker ikke skulle skje, sier Hammer til NTB.

Tallet på dødsfall i forbindelse med bruk av sykeutstyr har ligget på mellom 7-8 til 12-14 i de siste årene.

I tillegg til dødsfallene var det 39 skader i forbindelse med bruk av teknisk sykeutstyr og 102 nesten-ulykker i fjor. I de siste årene har tallet på dødsfall, skader og nesten-ulykker ligget på omkring 200 i året. Tallet på tilfeller har med andre ord vært forholdsvis stabilt, opplyser Hammer. (...)

FDA report details flaws in med tech surveillance
fiercehealthcare.com (24.1.2006)
One of the factors which has given med tech an edge over pharma and biotech in recent years has been a comparative lack of regulation. That may be changing. The FDA this week released an internal report that concedes the agency could be doing more to regulate medical devices.

According to researchers, the Center for Medical Devices and Radiological Health, the agency body responsible for tracking potential problems, often does not have access to the data it needs to evaluate products after they reach the market. The information collected is usually not complete, the report adds, making it almost impossible for the agency to determine how serious a problem is and evaluate appropriate steps needed to address it. The FDA notes it is working toward an electronic system for monitoring and collecting data on errors and considering other changes designed to improve post-marketing surveillance.
- see this report from the FDA (pdf)

The Government Accountability Office (GAO) today released the following reports, testimony, and correspondence (30.9.2005)
Food and Drug Administration: Limited Available Data Indicate That FDA Has Been Meeting Some Goals for Review of Medical Device Applications. GAO-05-1042, September 30 http://www.gao.gov/cgi-bin/getrpt?GAO-05-1042
Highlights - http://www.gao.gov/highlights/d051042high.pdf (...)

F.D.A. Data on Defibrillators Expected (FDA-data på defibrillatorer forventet)
New York Times 16.9.2005
-Food and Drug Administration har planer om å frigi en studie på fredag på et møte med hjertespesialister, som viser at implanterbare hjertedefibrillatorer, har hatt en økende forekomst av funksjonsfeil, opplyste en byråleder. (...) (- The Food and Drug Administration plans to release a study on Friday at a meeting of heart specialists that shows that implantable heart defibrillators have been malfunctioning at an increasing rate, an agency official said.)

Studien fant at funksjonsfeil ved pacemaker eller defibrillator var direkte ansvarlig for 61 bekreftede dødsfall av nesten tre millioner innretninger implantert i studieperioden. (...) (The study found that pacemaker or defibrillator malfunctions were directly responsible for 61 confirmed deaths out of the nearly three million devices implanted in the study period.)

F.D.A. Had Report of Short Circuit in Heart Devices (FDA hadde rapporter på kortslutning i hjerteutstyr)
The New York Times 12.9.2005
Dokumenter som New York Times har fått tilgang til viser at Food and Drug Administration, måneder før de gikk ut med en sikkerhetsvarsel i juni om problemer med hjerteustur fra Guidant Corporation, hadde mottatt en rapport fra et firma som viste at noen av enhetene var kortsluttet. (...) (Months before the Food and Drug Administration issued a safety alert in June about problems with Guidant Corporation heart devices, the agency received a report from the company showing that some of those units were short-circuiting, agency records obtained by The New York Times show.)

Dr. Hauser sa at dersom byrået hadde opplyst om det, kunne det ha reddet herr Oukrops liv. (Dr. Hauser said that if the agency had disclosed it, it might have saved Mr. Oukrop's life.)

"De har trolig aldri lest rapporten," sa han. "Dette er bare skandaløst." (...) ("They probably didn't even read the report," he said. "This is just scandalous.")

Hospitaler bruger livsfarlige pumper
Berlingske Tidende 25.7.2005
Danske hospitaler bruger farlige medicinpumper, som har kostet menneskeliv i USA. Virksomheden bag pumperne advarer nu mod, at pumperne kan gå i stå, men vil ikke trække dem tilbage. Formanden for Folketingets sundhedsudvalg vil have pumperne fjernet. (...)

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