Drug Makers Fail To Disclose Zetia’s Serious Health Risks

Drug makers Merck and Schering-Plough never published the results of studies regarding Zetia, an anti-hyperlipidemic drug often prescribed to lower cholesterol levels. The studies raise issues about Zetias effect on the liver. Enhance, one research study of Zetia, was completed in April of 2006.

The results of Enhance have recently been discovered. The study contains information about Zetias risks on the liver. Some patients showed elevated liver enzymes and were dropped from the study. Merck and Schering-Plough who have been criticized for not releasing the results of the Enhance study, are said to probably earn around $5 billion from Zetia sales this year.

Doctors have claimed that Merck and Schering-Ploughs failure to disclose the results of their research promptly could have left the public with a view of Zetia that is misleading and more favorable in terms of its benefits and safety.

The studies were conducted from 2000 to 2003 and were not posted on industry web sites where companies are required to register results of all trials ongoing after October of 2002. References to these studies were discovered by New York Times in the briefing papers of the F.D.A. web site. Dr. Robert J. Spiegel, an executive at Schering, stated that the unpublished data was reviewed by the F.D.A and approved for use with side statins like Lipitor, Crestor or Zocor.

However, drug safety experts have stated that the F.D.A. is not quick enough to warn the public about popular medicines that have been discovered to have adverse effects, such as Vioxx, Avandia, and Zyprexa. Unlike the F.D.A., regulators in Canada and Australia have issued warnings about Zetia’s ability to cause pancreatitis, hepatitis, and even depression. These warnings which were issued since 2005, have been disregarded in the United States.

Doctors, in deciding what treatment steps to take, must weigh a drug’s possible side effects and risks with its benefits. However, there is a lack of evidence that proves Zetia can actually reduce strokes and heart attacks, something that cholesterol drugs intend to do. Medical research and evidence shows that statins used alone, like Lipitor can protect against stroke and heart attack.

Yale cardiologist, Dr. Harlan Krumholz, after being told about the unpublished Zetia studies, stated that There is important evidence, but its not in public view. Its hidden from investigators. The unpublished trials reveal that among those who took Zetia with a statin, 11 times as many people suffered serious health-related problems than those who took a statin alone and nearly all problems were related to the liver.

Even with this information, the F.D.A., in approving Zetia, regarded Zetias risks as minor without requesting Merck and Schering to conduct longer research trials. In 2004, the drug industry made a promise to make improvements in terms of disclosing results of research. And although Merck and Schering-Plough published results of studies of Zetia for periods of 12 weeks, patients who develop liver problems show signs of development after 12 weeks.

President Bush recently signed a new law enabling an increase in the penalties for drug companies that do not release information about their products promptly enough. However, the new law is only applicable to newer trials and the Zetia trials will not be covered by the laws guidelines and rules.

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