Statins: A row over the use of cholesterol-lowering drugs and accusations of scientific bias in the American medical community threaten to undermine confidence in cardiovascular therapy on both sides of the Atlantic.
The Center for Science in the Public Interest (CSPI), a lobby group made up of prominent university doctors, has challenged the National Institutes of Health (NIH), America's co-ordinating body for health research and public policy advice, to appoint an independent panel to review cholesterol-lowering advice.
In a petition signed by more than 30 doctors, some from leading US hospitals and universities, the CSPI, whose membership is also drawn from Europe, warned that in drawing up its latest cholesterol treatment guidelines the NIH was relying on biased research and conclusions that misrepresent scientific evidence.
In July 2004 the NIH revised the conditions under which doctors might prescribe statins (cholesterol-lowering drugs). The NIH said statins could be used in cases where patients had no evidence of heart disease, opening up a larger population for the drugs. Until July statins were regarded as appropriate where patients needed protection from the risks of a second heart attack.
The CSPI noted statin manufacturers had funded the research on which NIH recommendations were based. Apart from the potential conflict of interest, the scientists also argued conclusions drawn from the research were simply wrong. They contended, for example, that the NIH's advice to prescribe statins to women with a moderately high risk of heart disease was unwarranted and not supported by any of the studies the NIH cites.
The CSPI's petition is part of an assault on cholesterol advice, not just in relation to statins but also to official dietary guidelines. The use of statins and recommendations for cholesterol-lowering food among women has become particularly controversial.
Radical nutritionists such as Mary Enig, author of Know Your Fats, said cholesterol-lowering diets among women were harmful. In support of Enig's view, Jeanne Driscoe, a medical doctor and nutritionist, and director of the Kansas University Center for Integrative Medicine, said: "There are now worrying signs that people who reduce their consumption of saturated fat [a major source of LDL cholesterol] in favour of Omega fats tend to suffer bleeding problems." Dr Driscoe is not affiliated to the CPSI or the cholesterol sceptics' lobby.
The CSPI petition, reported in the current issue of the British Medical Journal, was circulated around the internet among food campaigners.
The evidence on women who take statins, and are at moderately high risk of a heart attack, according to the CSPI, points to the possibility that statins might cause an increased risk of cardiovascular problems, though that risk is not statistically significant in the small trials the manufacturers report. The CSPI also cites statistics suggesting statin use may increase cancer risk.
The NIH has indicated it is standing by its advice.