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In January, users of the prescription cholesterol medicines ezetimibe (ZETIA) and the combination drug ezetimibe and simvastatin (VYTORIN) received some troubling news from the makers of the drugs: A newly-released study showed that although the pills lower cholesterol, there is no evidence that they reduce the risk of heart attacks and strokes, and may, in fact, be putting patients at risk. One of the ingredients of VYTORIN, simvastatin, does lower cholesterol and reduce the risk of heart...
In January, users of the prescription cholesterol medicines ezetimibe (ZETIA) and the combination drug ezetimibe and simvastatin (VYTORIN) received some troubling news from the makers of the drugs: A newly-released study showed that although the pills lower cholesterol, there is no evidence that they reduce the risk of heart attacks and strokes, and may, in fact, be putting patients at risk. One of the ingredients of VYTORIN, simvastatin, does lower cholesterol and reduce the risk of heart attacks and strokes when used alone. Simvastatin is available as a generic drug, while VYTORIN and ZETIA do not yet have generic counterparts.
We first warned Worst Pills, Best Pills News readers against using VYTORIN in a December 2004 article. The article stated that people should wait at least seven years before taking this new combination 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 regardless of how small of an amount of this combination drug was used, warning that tests showed serious toxicity in laboratory animals.
The 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 January 2008.
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 may even 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, it is estimated that the drug industry will give $400 million to the drug division of the FDA. This money 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.
What you can do
People who have been taking ZETIA or VYTORIN to lower their cholesterol should talk with their doctors and find an alternate treatment. A lifestyle consisting of a healthy diet, adequate rest, exercise and no smoking is the best prevention of cardiovascular disease. If lifestyle changes are not enough, some patients, especially those who have already had a heart attack or stroke, should consider drugs such as lovastatin (MEVACOR), atorvastatin (LIPITOR), simvastatin (ZOCOR), pravastatin (PRAVACHOL) or extended release niacin (NIASPAN). All of these drugs have been shown to prevent heart attacks.
