Back in November I wrote about a study which, like others that came before it, casts doubt about the benefits of cholesterol reduction. In this study, combining a stating with ezetimibe (which reduces cholesterol absorption from the gut) produced less favourable outcomes than a statin coupled with niacin (vitamin B3) in terms of arterial health. According to one commenter referring to this and other studies “”there is not a shred of evidence that it [ezetimibe] does anything good for blood vessels or heart disease.”
The repeated failure of ezetimibe to do anything apparently useful was picked up last week in a piece which appeared in the Journal of the American Medical Association . One of the important points made by the piece is that ezetimibe was licensed by the FDA in the US on the basis of its cholesterol-lowering properties. The piece goes on to highlight the fact that this ‘benefit’ has not been proven to translate into real clinical benefit (say, in terms of reduced risk of heart attack or death). The questions asks why so many doctors are prepared to prescribe a drug that has not been proven to do anyone any good.
In response to this, one commenter attributes this at least in part to people’s inability to question their own actions. “Physicians say, ‘This is my practice, and I think I am doing the right thing,'” was his comment. Another commenter suggested “There is a problem in America, and that is clinical inertia,” he said. “When evidence comes out, physicians are slow to change their prescription patterns.”
Another reason for the enthusiasm doctors appear to have for ezetimibe concerns the effective marketing of this, essentially, unproven agent. Its success is based on its ability to reduce cholesterol, remember, not on any evidence that it saves peoples lives or prevent heart attacks.
The article quotes Peter Kim, president of Merck Research Laboratories (Merck makes and markets ezetimibe). He says “Given the broadly accepted, scientifically validated importance of lowering LDL and the millions of people in the United States alone who are not at their recommended treatment goals, Vytorin [a combination of the statin simvastatin and ezemetimibe] and Zetia [ezetimibe] remain effective options for physicians to treat their appropriate patients.”
Obviously, one would expect a representative of Merck to attempt to put our focus on cholesterol rather than the absence of evidence for clinical benefit. The thing is, though, even if cholesterol reduction is broadly beneficial, that does not mean that something that reduces cholesterol is automatically beneficial. As I’ve mentioned before, if a known poison such as arsenic or cyanide was shown to have cholesterol-reducing properties, that would not be a reason for swallowing that poison every day.
Also, is cholesterol-reduction really beneficial? Previously, I have reported on evidence which links lowered cholesterol levels with an increased risk of death, with particular links to an increased risk of cancer. And perhaps it’s important not to forget that ezetimibe itself has been linked with an increased risk of death due to cancer.
Make no mistake about it, the aggressive and effective marketing of ezetimibe should remind us of just how important it is to have drugs licensed not on the basis of their impact on supposed markers of health (e.g. cholesterol levels), but on actual health and risk of disease and death.
1. Mitka M. Cholesterol Drug Lowers LDL-C Levels But Again Fails to Show Clinical Benefit. JAMA. 2010;303(3):211-212.