"The only sure benefit of doubling the market for statins
is to the bottom line of the drug companies."
Guidelines for medical treatment promulgated by medical specialty societies greatly influence doctors and public attitudes. The guidelines on cardiovascular risk released last week, if followed, would result in a doubling of the number of Americans taking statin drugs to prevent heart attacks and strokes.
But, as is often the case with specialty societies, the groups behind these new proposals, the American College of Cardiology and the American Heart Association,
Moreover, members of their guideline committees often work as paid consultants or speakers for companies whose sales will be affected by the guidelines. About half the members of the committee that wrote the cholesterol guidelines had financial ties to the makers of statins, The Boston Globe reported.
In 2005, a Food and Drug Administration advisory committee said it was O.K. to keep arthritis drugs like Vioxx on the market, despite evidence that their use increased the risk of heart attacks and strokes. But it was later revealed that 10 of the 32 members of the committee had ties to the companies that made the drugs. If their votes were discounted the decision would have gone the other way.
Another problem: Instead of targeting cholesterol levels, the new cardiac guidelines target all risk factors that together would predict at least a 7.5 percent chance of a heart attack or stroke in 10 years – including age, smoking and high blood pressure. Thus, you might be subject to statin treatment even if your “bad” cholesterol is quite low.
But why take a drug designed to lower cholesterol if that's not your problem? That seems nonsensical, unless there is very good evidence that statins have other, relevant effects. And that gets to the heart of the matter.
Far-reaching guidelines should be based on strong scientific evidence from randomized controlled clinical trials. Without it, all we have is the opinion of a group that, even though expert, has a financial conflict of interest.
(*) Marcia Angell is a senior lecturer in social medicine at Harvard Medical School. She is the former editor in chief of The New England Journal of Medicine.
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