Jan. 14, 2008

Drug Companies, FDA Lagged in Warning Public About Zetia, Vytorin

Statement by Sidney Wolfe, M.D., Director of Public Citizen’s Health Research Group

Users of the prescription cholesterol medicine Zetia and Vytorin received some troubling news from the makers of the drug today: Although the pills they’re taking lower their cholesterol, there is no evidence that they reduce the risk of heart attacks and strokes, and may, in fact, be putting them at risk.

We first warned against using Vytorin, a combination of Zetia and the cholesterol drug Zocor (now generically available as simvastatin), in December 2004 on our Web site, WorstPills.org. At the time, we said that people should wait at least seven years before taking this new drug, considering that Vytorin wasn’t a “breakthrough” drug, which offers a documented advantage over older, proven drugs.

The Food and Drug Administration's (FDA) own pharmacology reviewer recommended against approval of Vytorin, warning that tests showed serious toxicity in laboratory animals, regardless of how small of an amount of this combination drug was used.

Now, a clinical trial by Merck and Schering-Plough adds to our concerns. It is disturbing that the companies completed the trial in April 2006 but found excuse after excuse not to release the unfavorable results to the public until today.

Unfortunately, we are not surprised. There’s a $20 billion market for cholesterol-lowering drugs and companies will do whatever it takes to get as much of that market as they can, even if it means letting people continue to take prescription drugs that they know are not beneficial and that even may be harmful.

Merck and Schering-Plough offer the excuse that their data are complicated and their analysis of the clinical trial took much longer than anticipated. We’re not convinced. What’s much more likely is that the companies put their stockholders above their responsibility to public health.

We wish we could say this is an isolated case but there are too many other examples of negative findings being buried in the FDA’s files. This year, the drug industry gave $400 million to the drug division of the FDA, which   funds most of the salaries of those scientists who review drugs. You would have to be living on a cloud to think that the money doesn’t have an impact on the FDA’s drug approvals or regulation of the industry.

At the very least, what we learned today is that people who have been taking Vytorin should talk with their doctors and find a better medication.

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