complementaire en alternatieve geneeskunde
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Complementaire behandelwijzen Maatschappij Noodklok over 'objectief' onderzoek
| Noodklok over 'objectief' onderzoek |
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Het Amerikaanse tijdschrift JAMA luidde in September 2008 de noodklok. Veel onderzoek naar de effectiviteit en veiligheid van medicijnen is helemaal niet objectief! In de inleiding van het artikel meteen de feiten. Antibiotica die onderzocht worden door de industrie zelf, lijken in de artikelen die daarover in de pers verschijnen veiliger te zijn dan ze in werkelijkheid zijn! Manipulatie van onderzoeksgegevens komt dus nog steeds voor! We citeren: Over the past 2 decades, the pharmaceutical industry has gained unprecedented control over the evaluation of its own products. Drug companies now finance most clinical research on prescription drugs, and there is mounting evidence that they often skew the research they sponsor to make their drugs look better and safer. Dit bleek weer zo te zijn in twee recente artikelen over een veel gebruikte pijstiller: Clinical research that is published is often biased, usually by designing the studies in ways that will almost inevitably yield favorable results for the sponsor. This can be done in many ways. For example, comparator drugs may be administered at a too-low dose, so that the sponsor's drug looks more effective, or at a too-high dose, so that the sponsor's drug has relatively fewer adverse effects. Other maneuvers include choosing a composite outcome so that a favorable outcome can be selected as the "primary" end point; publishing only part of the data, as in the case of the publication of results from just the first half of the CLASS study of celecoxib, when the data were positive;[1] and downplaying evidence of serious adverse effects, as in the case of the VIGOR trial of rofecoxib.[2]Very often bias takes the form of comparing a new drug with a placebo when the relevant question is how it compares with an existing drug. OEPS! Richtlijnen ook niet 'objectief'Nu nog wat ergers! In de richtlijnen die aangeven hoe bepaalde aandoeningen behandeld kunnen worden, zitten ook bugs. We volgen JAMA op de voet nu:[3] Conflicts of interest may bias more than research. They may also affect influential practice guidelines issued by professional and governmental bodies, as well as decisions by the Food and Drug Administration (FDA). A study of 200 panels that issued practice guidelines found that more than one-third of the authors acknowledged that they had some financial interest in the drugs they recommended. [4] En dan over cholesterolverlagers. Ook hier werden de richtlijnen vastgesteld door niet onafhankelijke wetenschappers, 8 van de 9 panelleden hadden een financiele band met de makers van de statines.....: After the National Cholesterol Education Program, sponsored by the National Institutes of Health (NIH) in conjunction with the American Heart Association and American College of Cardiology, called for sharply lowering the desired levels of low-density lipoprotein cholesterol, it was revealed that 8 of 9 members of the panel writing the recommendations had financial ties to the makers of statins. Bron van deze gegevens: Tuller D. Seeking a fuller picture of statins. New York Times. July 20, 2004:D5. En we maken het nog ernstiger, ook de overheid in de VS is niet onpartijdig. En de richtlijnen voor het voorschrijven van medicijnen aan mensen met psychiatrische aandoeningen zijn eveneens niet zuiver: Of the 170 contributors to the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition), 95 had financial ties to drug companies, as did all contributors to the sections on schizophrenia and mood disorders. Perhaps most importantly, many members of the FDA's 16 standing committees that advise the FDA on drug approvals also have financial ties to drug companies. Although these individuals are supposed to recuse themselves from participating in decisions about drugs made by specific companies with which they have a financial relationship, that requirement is frequently waived by FDA authorities. En de redacteur van een van s'werelds meest invloedrijke medische bladen (the New England Journal of Medicine) stelt dan vervolgens: Looking at this picture altogether, it would be naive to conclude that bias is only a matter of a few isolated instances. It permeates the entire system. Physicians can no longer rely on the medical literature for valid and reliable information. This is the conclusion I reluctantly reached toward the end of my 2 decades as an editor of the New England Journal of Medicine, and it has been reinforced in subsequent years. Clinicians just do not know anymore how safe and effective prescription drugs really are, but these products are probably nowhere near as good as the published literature indicates. OEPS indeed! En wordt in Nederland recentelijk luid geroepen dat BTW op alternatieve geneeskunde nodig is, omdat het allemaal niet bewezen zou zijn...en dus 'kwakzalverij' zou zijn. Gemeten volgens dezelfde onderzoeksnormen komt dan in de reguliere geneeskunde minstens evenveel 'kwakzalverij' voor. Voor dit onloochenbare feit moeten de ogen van onze beleidsmakers en politici nu eens echt open gaan, en bovendien hun oren moeten sluiten voor de nergens op slaande kreet dat alternatieve geneeskunde allemaal niet bewezen is! Het tegendeel is waar. Dat hopen we nu met al die artikelen op IOCOB en onze nieuwsbrieven op indringende wijze duidelijk gemaakt te hebben. De schrijver van dit artikel schreef er een heel boek over: Angell M. The Truth About the Drug Companies: How They Deceive Us and What to Do About It. New York, NY: Random House; 2004. Literatuur in het stuk van Dr Angell: 1. Ross JS, Hill KP, Egilman DS, Krumholz HM. Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation.JAMA. 2008;299(15):1800-1812.
15. Angell M. The Truth About the Drug Companies: How They Deceive Us and What to Do About It. New York, NY: Random House; 2004.
Referenties[1]: Silverstein FE, Faich G, Goldstein JL, Simon LS, Pincus T, Whelton A, Makuch R, Eisen G, Agrawal NM, Stenson WF, Burr AM, Zhao WW, Kent JD, Lefkowith JB, Verburg KM, Geis GS. | Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: A randomized controlled trial. Celecoxib Long-term Arthritis Safety Study. | JAMA. | 2000 Sep 13;284(10):1247-55. [2]: Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, Day R, Ferraz MB, Hawkey CJ, Hochberg MC, Kvien TK, Schnitzer TJ; VIGOR Study Group. | Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. | N Engl J Med. | 2000 Nov 23;343(21):1520-8, 2 p following 1528. [3]: Angell M. | Industry-sponsored clinical research: a broken system. | JAMA. | 2008 Sep 3;300(9):1069-71. [4]: Taylor R, Giles J. | Cash interests taint drug advice. | Nature. | 2005 Oct 20;437(7062):1070-1.
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