Rapid Responses to:

NEWS: Jeanne Lenzer Longer, better studies of coronary stents are needed, FDA tells industry BMJ 2008; 336: 743 [Full text]

Rapid Responses: Submit a response to this article

Rapid Responses published:

When will NICE or the FDA make stent manufacturers prove they are not merely latter day snake oil salesmen?

Professor Michael R Chester, John Bridson, Clinical Ethicist   (9 April 2008)

When will NICE or the FDA make stent manufacturers prove they are not merely latter day snake oil salesmen? 9 April 2008
Professor Michael R Chester, Consultant Cardiologist & Director of the National Refractory Angina Centre (NRAC) Liverpool RLBUHT, Thomas Drive, L14 3PE, John Bridson, Clinical Ethicist Send response to journal: Re: When will NICE or the FDA make stent manufacturers prove they are not merely latter day snake oil salesmen?	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Institute for Health and Clinic Excellence (NICE) came to similar conclusions in 2007 and went so far as to issue draft guidance that drug eluting stents should not be implanted in coronary arteries.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). Both NICE and the FDA have examined the evidence base for PCI and would have been aware that most angioplasty procedures provide a mild and temporary improvement in symptoms and have no beneficial impact on prognosis. (2,3) Remarkably, both organisations have ignored the fact that the absence of a sham study means that PCI’s mild and temporary benefits may be entirely explained by the placebo effect. This is no mere theoretical possibility of interest only to evidence-based purists. Separate studies by Diamond and Cobb famously demonstrated that sham procedures can be highly effective in producing significant and sustained improvements in angina (4,5). The principle of preventing unnecessary harm to patients underlies ethical objections to undertaking sham studies of invasive procedures. On the other hand, the same principle undermines the justification for allocating resources to procedures such as PCI, which have not been shown to be more efficacious than placebo, both because of the potential harms caused by the procedures and because of the diversion of those resources away from safer and less costly evidence-based treatment strategies (6,7) References 1. http://www.bcis.org.uk/about/council last visited 6.04.2008 2. Boden et al. Optimal Medical Therapy with or without PCI for Stable Coronary Disease. N Engl J Med 2007; 356:1503-1516 3. RITA-2 Trial Participants. Coronary angioplasty versus medical therapy for angina: the second Randomised Intervention Treatment of Angina (RITA-2) trial. Lancet 1997;350:461–468 4. Dimond et al. Evaluation of internal mammary ligation and sham procedure in angina pectoris. Circulation 1958 18:712- 713 5. Cobb et al. An evaluation of internal mammary artery ligation by a double blind technique. New Engl J Med 1959 20:1115-1118 6. Griffin et al. Cost effectiveness of clinically appropriate decisions on alternative treatments for angina pectoris: prospective observational study. BMJ 2007;334:624 (24 March) 7. Chester MR. Coronary heart disease trends in England and Wales from 1984 to 2004: concealed levelling of mortality rates among young adults. Featured correspondence Heart, Feb 2008; 94: 229. Competing interests: Professor Chester provides consultancy advice to service commissioners on effective person centred health resource deployment