Healthy Skepticism Library item: 13485

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Chester MR, Bridson J.
When will NICE or the FDA make stent manufacturers prove they are not merely latter day snake oil salesmen?
BMJ 2008 Apr 9; epub
http://www.bmj.com/cgi/eletters/336/7647/743#193170

Abstract:

The US Food and Drugs Administration (FDA) have finally recognised that coronary stent manufacturers have not undertaken adequate long-term studies to establish the safety and efficacy of their products. The National Institute for Health and Clinic Excellence (NICE) came to similar conclusions in 2007 and went so far as to issue draft guidance that drug eluting stents should not be implanted in coronary arteries. NICE subsequently backed down under intense pressure from lobby groups including the influential British Cardiovascular Intervention Society (BCIS). Professional societies rightly have a proper place in providing unbiased advice that should be objective and free from vested interest. However, BCIS can make only a dubious claim to objectivity on the subject of stents, given that its board includes two representatives of the manufacturing industry (1)…

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NEWS:
Jeanne Lenzer
Longer, better studies of coronary stents are needed, FDA tells industry
BMJ 2008; 336: 743
http://www.bmj.com/cgi/content/extract/336/7647/743