Editorial: Reveal test results
Saturday, Nov. 24, 2007 | 7:28 a.m.
The maker of popular cholesterol-lowering drugs Zetia and Vytorin completed clinical trials of the drugs two years ago but still has not made the results of those tests public. And a growing number of cardiologists are demanding to know whether these drugs - prescribed to about 800,000 Americans each week - are effective in lowering the risk of heart attack along with lowering LDL, or bad, cholesterol, The New York Times has reported.
Officials from Merck-Schering Plough Pharmaceuticals, manufacturer of the two drugs, say they will release some of the test results in March. But doctors told the Times the company should make all its test results public because doctors need to know whether their patients are unnecessarily risking heart attacks by taking drugs that in clinical trials only lowered cholesterol.
The critics, who include the head of cardiology at Walter Reed Army Medical Center, also say Merck-Schering Plough changed the scope and goal of the clinical trials after the tests were started - a practice that isn't considered scientifically sound because someone could change a study's goal to fit emerging results.
Two years ago the pharmaceutical industry promised to post on a federally funded Web site the results of clinical trials, which continue after a drug has been released to study long-term efficacy and side effects. At the time, the industry was being criticized for withholding information about negative test results. But companies don't face penalties for failing to release the results of clinical trials or for releasing only partial information.
This isn't right. People depend on drugs to keep them healthy and, in many cases, alive. Congress should work with federal drug regulators to require drug companies to release all clinical trial information and punish those that refuse to do so.
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