Overvåkning etter markedsføring — Mangel på årvåkenhet, mangel på tillit. (Postmarketing Surveillance—Lack of Vigilance, Lack of Trust) (JAMA. 2004;292:2647-2650 (November 22))
The Food and Drug Administration "lacks a clear and effective process" for managing postmarket drug safety issues, says a Government Accountability Office report out Monday. (usatoday.com 23.4.2006)
Den någjeldende godkjenningsprosess for legemidler og biologiske substanser i USA er imidlertid utsatt for et intenst kritisk og undersøkende blikk, spesielt på grunn av bekymringer om påvirkning fra industrien. (Journal of the American Medical Association (JAMA))
FDA kritiseres for legemidlers sikkerhetsproblemer (FDA Is Criticized Over Drugs' Safety Problems) (washingtonpost.com 24.4.2006)
Keeping Science on Top in Drug Evaluation (NEJM 2007; 357:633-635 (August 16))
FDA kritiseres for legemidlers sikkerhetsproblemer
US FDA slammed over post-marketing studies
pharmatimes.com 28.10.2009
The US Food and Drug Administration (FDA) fast-track approval process for drugs to treat serious and life-threatening conditions requires makers to conduct post-marketing studies on their products, but a new study has found that some such studies have still not been completed more than eight years after the drugs were approved for marketing. (...)
Bristfällig redovisning av biverkningar i studier
lakemedelsvarlden.se 27.10.2009
Biverkningar rapporteras inte på ett tillfredsställande sätt i kliniska studier. Det visar en färsk genomgång av artiklar i världens mest inflytelserika medicinska tidskrifter. (...)
Franska forskare har granskat samtliga randomiserade, placebokontrollerad och dubbelblinda kliniska studier som jämför två behandlingar och publicerats i någon av världens sex mest inflytelserika vetenskapliga tidskrifter mellan 1 januari 2006 och 1 januari 2007. Resultatet publiceras i veckan nummer av Archives of internal medicine.
Visserligen nämndes biverkningar i närmare nio av tio artiklar. Men rapporteringen är allt annat än tillfredsställande, menar forskarna.
I hälften av artiklarna framgick det inte om patienter avbrutit behandlingen på grund av biverkningar och i tre av tio artiklar saknades information om allvarliga biverkningar. (...)
I en ledarkommentar i samma nummer av tidskriften poängteras att de flesta nya behandlingar endast har en liten, om ens någon, fördel i effekt jämfört med redan befintliga behandlingar. Därför är skillnader i biverkningar självklart en viktig faktor vid valet av behandling.
FAKTA: TIDSKRIFTERNA SOM UNDERSÖKTES:
• New England Journal of Medicine (NEJM)
• Lancet
• JAMA
• BMJ
• Annals of Internal Medicine
• PLoS Medicine (...)
Industry Years Behind on Testing Approved Drugs
nytimes.com 26.10.2009
WASHINGTON — Federal drug officials have long been criticized for failing to force drug makers to complete studies proving that their drugs work as hoped, and Congressional investigators on Monday released yet another report pointing out that some of these studies remain undone many years after being promised.
The result is that doctors and patients remain unsure whether some critical medicines used to treat illnesses like cancer and heart disease are actually beneficial. (...)
FDA Is Criticized Over Drugs' Safety Problems
washingtonpost.com 24.4.2006
Response to Approved Medications Cited
The Food and Drug Administration is sometimes too slow in picking up safety problems once drugs are on the market and in responding to emerging danger signals, a federal study concluded in a report to be released today.
The review by the Government Accountability Office found that the FDA does not have clear policies for addressing drug safety issues and that it sometimes excludes its best safety experts from important meetings. (...)
Report questions FDA's safety procedures (Rapport stiller spørsmål ved FDAs sikkerhetsprosedyrer)
usatoday.com 23.4.2006
The Food and Drug Administration "lacks a clear and effective process" for managing postmarket drug safety issues, says a Government Accountability Office report out Monday. (The Food and Drug Administration "lacks a clear and effective process" for managing postmarket drug safety issues, says a Government Accountability Office report out Monday.)
The report was requested in late 2004 by Sen. Charles Grassley, R-Iowa, chair of the Senate Finance Committee, and Rep. Joe Barton, R-Texas, chair of the House Energy and Commerce Committee. (The report was requested in late 2004 by Sen. Charles Grassley, R-Iowa, chair of the Senate Finance Committee, and Rep. Joe Barton, R-Texas, chair of the House Energy and Commerce Committee.)
Concerns about how the FDA handled high-profile drug safety cases — two were Vioxx, the painkiller linked to heart attacks and strokes, and antidepressants, linked to suicidal behavior in children — spurred the request. (Concerns about how the FDA handled high-profile drug safety cases — two were Vioxx, the painkiller linked to heart attacks and strokes, and antidepressants, linked to suicidal behavior in children — spurred the request.)
"GAO observed that there is a lack of criteria for determining what safety actions to take and when to take them," the report states, noting that FDA officials, given a chance to review a draft, called its conclusions "reasonable" but did not comment on its recommendations. ("GAO observed that there is a lack of criteria for determining what safety actions to take and when to take them," the report states, noting that FDA officials, given a chance to review a draft, called its conclusions "reasonable" but did not comment on its recommendations.)
In an interview Friday, Grassley said the report backs up "what everybody seems to know, that the FDA needs reform, that things that go on in the FDA don't really protect the consumer. The FDA is kind of a Good Housekeeping seal of approval on drugs, and really, it's questionable (whether) they should have that honor." (In an interview Friday, Grassley said the report backs up "what everybody seems to know, that the FDA needs reform, that things that go on in the FDA don't really protect the consumer. The FDA is kind of a Good Housekeeping seal of approval on drugs, and really, it's questionable (whether) they should have that honor.")
A Proposal For Financing Postmarketing Drug Safety Studies By Augmenting FDA User Fees. (Et forslag til finansiering av studier på legemiddelsikkerhet etter markedsføring ved å øke FDA-brukergebyrer.)
Health Affairs (18 October 2005)
En trinnvis politisk reform som ville gjøre det mulig for FDA å komme seg ut av det nåværende dilemma angående legemiddelsikkerhet og publikums tillit. (An incremental policy reform that would enable the FDA
and others to exit the current dilemma regarding
drug safety and public trust.)
User fees
FDA Negotiating With Pharmaceutical Companies for Increase in User Fees
kaisernetwork.org 1.9.2006
Kaiser Daily Health Policy Report
Prescription Drugs
FDA officials and representatives of the pharmaceutical industry are in negotiations over the user fees that companies pay the agency to help fund the drug review process, the Wall Street Journal reports. According to the Journal, "Exact details of the deal they strike likely will take shape in the next few weeks." Under the 1992 Prescription Drug User Fee Act, pharmaceutical companies agreed to pay fees to FDA, and in return the agency agreed to aim to review drugs in 12 months or less. The companies pay fees when they file drug applications, and they also pay fees based on the number of manufacturing facilities they operate and the number of products they sell in the U.S. In fiscal year 1993, the industry paid a total of $8.9 million in user fees, accounting for 7% of the agency budget. The new PDUFA agreement, which must be approved by Congress, would begin Oct. 1, 2007. Each of the two times PDUFA has been renewed, "FDA has gained new funding," and the "industry has wrung concessions," the Journal reports. (...)
Overvåkning etter markedsføring — Mangel på årvåkenhet, mangel på tillit
Reporting of Conflicts of Interest in Meta-analyses of Trials of Pharmacological Treatments (Rapportering av interessekonflikter i metaanalyser av farmakologiske forsøksbehandlinger)
JAMA 2011;305(10):1008-1017 (March 9)
Context Disclosure of conflicts of interest (COIs) from pharmaceutical industry study funding and author-industry financial relationships is sometimes recommended for randomized controlled trials (RCTs) published in biomedical journals. Authors of meta-analyses, however, are not required to report COIs disclosed in original reports of included RCTs.
Objective To investigate whether meta-analyses of pharmacological treatments published in high-impact biomedical journals report COIs disclosed in included RCTs. (...)
Conclusion Among a group of meta-analyses of pharmacological treatments published in high-impact biomedical journals, information concerning primary study funding and author COIs for the included RCTs were only rarely reported. (...)
Postmarketing Surveillance—Lack of Vigilance, Lack of Trust (Overvåkning etter markedsføring — Mangel på årvåkenhet, mangel på tillit.)
JAMA. 2004;292:2647-2650 (November 22)
Leger og pasienter forventer at når legemidler forskrives korrekt på indikasjoner anført i preparatomtalen og brukt som foreskrevet, vil disse legemidler som oftest ha nytteeffekter og ikke forårsake betydningsfull skade. Denne tillit til farmasøytiske produkter reflekterer tiltro til effektivitet og integritet ved legemiddelgodkjenning og overvåkningsprosess. (Physicians and patients expect that when medications are prescribed correctly for labeled indications and are used as directed, these medications generally will have beneficial effects and will not cause significant harm. This confidence in pharmaceutical products reflects trust in the effectiveness and integrity of the drug approval and monitoring process.)
Den någjeldende godkjenningsprosess for legemidler og biologiske substanser i USA er imidlertid utsatt for et intenst kritisk og undersøkende blikk, spesielt på grunn av bekymringer om påvirkning fra industrien. For eksempel etter godkjenningen av Prescription Drug User Fee Act i 1992, som økte budsjettet til Food and Drug Administration (FDA) ved innkreving av såkalt "brukerbetaling" fra farmasøytiske firmaer,1 har FDA mottatt omtrent 825 millioner dollar i godtgjørelse fra legemiddel- og biologiske produsenter i skatteårene 1993 t.o.m. 2001.2-3 I løpet av denne tiden, er median standard godkjenningstid for (dvs., "ikke-prioriterte") legemidler redusert fra 27 måneder i 1993 til 14 måneder i 2001, men som et uunngåelig resultat av raskere godkjenninger, er tilbaketrekninger av legemidler etter godkjenning økt fra 1,56 % i 1993-1996 til 5,35 % i 1997-2001.2 I tillegg, avslørte en granskning av 18 rådgivende ekspertgrupper hos FDA at mer enn halvparten av medlemmene i disse gruppene hadde direkte økonomiske interesser i legemidlet eller de emner som de vurderte og som de utarbeidet anbefalinger for.4 (...) (However, the current approval process for drugs and biological agents in the United States has come under intense scrutiny, most notably because of concerns about influence from industry. For instance, since adoption of the 1992 Prescription Drug User Fee Act, which augmented the budget of the Food and Drug Administration (FDA) by charging "user fees" to pharmaceutical firms,1 the FDA has received approximately $825 million in fees from drug and biologic manufacturers from fiscal years 1993 through 2001.2-3 During that time, median approval times for standard (ie, "nonpriority") drugs decreased from 27 months in 1993 to 14 months in 2001, but as an inevitable consequence of faster approvals, drug recalls following approval increased from 1.56% for 1993-1996 to 5.35% for 1997-2001.2 In addition, an investigation of 18 FDA expert advisory panels revealed that more than half of the members of these panels had direct financial interests in the drug or topic they were evaluating and for which they were making recommendations.4)
Systemet for overvåkning etter markedsføring krever en betydelig og lenge påkrevd omstrukturering. Før det skjer — som indikert i artikler i denne utgaven av JAMA, som legger frem nylige bevis på alvorlig skade fra mye brukte og tungt promoterte legemidler, som påvist gjennom industriens påvirkning av data etter markedsføring, og som belyser hvor langt enkelte produsenter er villige til å gå for å beskytte sine interesser — vil USA fremdeles være langt unna det å ha et effektivt, vaktsomhet, og pålitelig system for overvåkning etter markedsføring for beskyttelse av publikum. (The postmarketing surveillance system requires a long overdue major restructuring. Until that occurs—as indicated by the articles in this issue of JAMA, as epitomized by recent evidence of serious harms from widely used and heavily promoted medications, as demonstrated by the influence of industry over postmarketing data, and as illustrated by the lengths to which some manufacturers will go to protect their interests—the United States will still be far short of having an effective, vigilant, and trustworthy system of postmarketing surveillance to protect the public.)
(Anm: median;
(av lat., 'som befinner seg i midten') midttall, midtverdi.
(statistikk). I statistikken er medianen den verdien av en variabel (f.eks. lønn, alder, høyde) som ligger midt i det statistiske materialet, det vil si at like mange individer i materialet har verdier over medianen som under den. Den foretrekkes fremfor det aritmetiske gjennomsnitt når man ønsker å beskrive den sentrale tendensen i materialet og ikke vil gi ekstreme verdier stor vekt. (Kilde: Store norske leksikon.)
Reporting Conflicts of Interest, Financial Aspects of Research, and Role of Sponsors in Funded Studies (Rapportering av interessekonflikter, økonomiske aspekter av forskning, og sponsorers rolle i betalte studier.)
JAMA 2005;294:110-111 (July 6)
FORSKNINGSSTUDIER I BIOMEDISINSKE TIDSSKRIFTER GRANSKES I ØKende grad, ikke bare deres vitenskapelige funn, kliniske konsekvenser, og konsekvenser for folkehelsen, men også på grunn av bekymringer i forbindelse med interessekonflikter hos granskerne1 angående villedende rapportering av industrisponset forskning.2(...) (RESEARCH STUDIES IN BIOMEDICAL JOURNALS ARE INcreasingly scrutinized, not only for their scientific findings and clinical and public health Implications, but also because of concerns related to conflicts of interest of investigators1 and concerns about misleading reporting of industry-sponsored research.2
I denne lederartikkelen gjennomgår og oppdaterer vi vår strategi for forfatternes rapportering av interessekonflikter og redegjørelse av økonomisk støtte og andre betalte bidrag for deres arbeid, så vel som krav om rapportering av industrisponsede studier. Mye av denne informasjon og fornuftsgrunnlaget for disse strategier er tidligere beskrevet i lederartikler4 og er detaljert i de gyldige JAMA- instruksjoner for forfatterne.5 (...) (In this editorial, we review and update our policies for authors reporting conflicts of interest and disclosing financial support and other paid contributions for their work, as well as the requirements for reporting of industry-sponsored studies. Much of this information and the rationale for these policies have been described in previous editorials4 and are detailed in the current JAMA Instructions for Authors.5)
Mens vi erkjenner at disse fremgangsmåter ikke er ufeilbarlige, tror vi fortsatt at mer transparent rapportering bør hjelpe til å sikre integriteten til medisinsk vitenskap; som setter leger, andre helsefagfolk, og publikum i stand til å fortolke resultatene fra vitenskapelige studier på riktig måte; og opprettholder publikums tiltro til biomedisinsk forskning. (While we recognize that these policies are not infallible, we continue to believe that more transparent reporting should help ensure the integrity of medical science; enable physicians, other health professionals, and the public to interpret the results of scientific studies appropriately; and maintain public confidence in biomedical research.)
Keeping Science on Top in Drug Evaluation
Keeping Science on Top in Drug Evaluation
NEJM 2007; 357:633-635 (August 16)
In many sectors of American life — energy, defense, finance, pharmaceuticals — the government stands poised between powerful industry groups and the needs of the citizenry. (...)
Of course, the system doesn't always perform as well as it should. In recent years, the FDA has been less stringent about allowing the participation of committee members who have commercial conflicts of interest, despite evidence that such ties help shape opinions.1 (...)
The same reauthorization bill, disappointing in so many respects, may tighten somewhat the conflict-of-interest rules for outside advisers. In addition, some recent committee decisions provide interesting contrasts with recommendations made several years ago about similar drugs.
During the 1999 approval process for rofecoxib (Vioxx, Merck), FDA internal reviewers noted early signals of a possible increase in cardiovascular risk. But the advisory committee focused instead on the hope that the drug would have less gastrointestinal toxicity than other nonsteroidal antiinflammatory drugs (NSAIDs), though such an advantage had not yet been convincingly demonstrated. When a quadrupling of the rate of myocardial infarction was documented a year later in a clinical trial comparing rofecoxib with naproxen, the agency allowed the company to imply that this was because of the cardioprotective effect of naproxen. (...)
Diverse artikler
New FDA Regulation to Improve Safety Reporting in Clinical Trials (Ny FDA-regulering for å forbedre sikkerhetsrapportering i kliniske forsøk)
NEJM 2011 (June 8)
As part of an initiative designed to modernize the clinical trial enterprise, the Food and Drug Administration (FDA) recently published a regulation establishing a new safety-reporting paradigm for drugs being studied under investigational new drug applications (INDs).1 This rule — published last September and effective as of March 28, 2011 — is one in a series of steps the FDA is taking to enhance the protection of human subjects and improve trial conduct by streamlining the regulatory procedures for clinical trials. (...)
EMA rapped over access to adverse drug action reports (EMA skarpt kritisert over tilgang til rapporter for uheldige legemiddelvirkninger)
pharmatimes.com 11.5.2010
The European Ombudsman has urged the European Medicines Agency (EMA) to reconsider its refusal to provide access to documents relating to suspected adverse drug reactions (ADRs), stating that its failure to do so “constitutes an instance of maladministration.”
The case concerns an Irish citizen who in April 2008 had asked the EMA for reports on suspected ADRs relating to a nationally-authorised drug used in the treatment of severe forms of acne, such as those reactions which give rise to suicidal tendencies. The EMA refused such access, arguing that European Union (EU) transparency rules do not apply to ADR reports.
In September 2008 the complainant brought his case before the European Ombudsman, Nikiforos Diamandouros, who yesterday announced that he disagreed with the EMA’s argument and that, in his view, EU transparency rules apply to all documents held by the Agency.
Given that the EMA’s work has a direct impact on the health of European citizens, it is “of the utmost importance” for the EMA to give “the widest possible access to documents and also to pursue a pro-active information policy for the benefit of citizens,” said Mr Diamandouros. (...)
Is the conflict of interest unacceptable when drug companies conduct trials on their own drugs? Yes (Er interessekonflikter uakseptable når legemiddelfirmaer utfører forsøk på sine egne legemidler? Ja)
BMJ 2009;339:b4949 (29 November)
Ben Goldacre argues that the financial interests of drug companies lead to distorted evidence, but Vincent Lawton (doi:10.1136/bmj.b4953) believes that adequate safeguards exist to keep bias in check
The practice of medicine is based on evidence. We need this evidence base to be complete, and of the highest quality, so that we can make the right decisions, but at present, drug companies produce most of the evidence we use. There is no doubt that these companies have a conflict of interest when they conduct trials: they want to sell their products, and so naturally they want a positive result from the trials they sponsor. But there is now good evidence from systematic reviews, meta-analyses, and case studies that this conflict of interest results in bad evidence, which distorts medical decision making and so harms patients. (...)
Is the conflict of interest unacceptable when drug companies conduct trials on their own drugs? No (Er interessekonflikter uakseptable når legemiddelfirmaer utfører forsøk på sine egne legemidler? Nei)
BMJ 2009;339:b4953 (29 November)
Ben Goldacre (doi:10.1136/bmj.b4949) argues that the financial interests of drug companies lead to distorted evidence, but Vincent Lawton believes that adequate safeguards exist to keep bias in check
The drug industry is sometimes accused of finding it difficult to reconcile the difference between the strict disciplines of ethical science and its responsibility to its shareholders to return a healthy profit. Proposals to move control of this critical process in drug development into the hands of an "objective" third party need to be critically examined. Clinical trials are properly managed by a rigorous system of regulatory scrutiny throughout. Potential for conflict of interest, when clearly identified and controlled, is not unacceptable. (...)
- Fant fullt av feil i medisindatabase for leger
vg.no 9.1.2009
Allmennlegeforeningen: - Kan være meget alvorlig
(VG Nett) Legemiddelindustrien reagerer overfor Statens Legemiddelverk etter at en søkebase for medisiner viser seg å inneholde en rekke feilaktige opplysninger. (...)
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