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Dr. Gregory Pais, ND
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A clinical trial of a widely used cholesterol drug has raised questions both about the medicine's effectiveness and about the behavior of the pharmaceutical companies that conducted the study.

Merck and Schering-Plough, which make the drug, Zetia, and a pill that contains it, Vytorin, found Zetia had failed to benefit patients in a two-year trial that ended in April 2006. Why is this only coming out now? Merck and Schering repeatedly missed their own deadlines for reporting the results while millions of patients have continued taking Zetia and Vytorin. Zetia and Vytorin account for about 20% of the cholesterol drugs on the U.S. market. Sales of the two drugs were $5 billion in 2007, and make up part of Merck's and Schering's profits.

In a press release, Merck and Schering said that not only did Zetia fail to slow the accumulation of fatty plaque in the arteries; it actually seemed to contribute to plaque formation.

"This is as bad a result for the drug as anybody could have feared," said Dr. Nissen, senior consulting editor to the Journal of the American College of Cardiology. "Millions of patients may be taking a drug that does not benefit them, raising their risk of heart attacks and exposing them to potential side effects," he said. "Patients should not be given prescriptions for Zetia unless all other cholesterol drugs have failed," he said.

The House Energy and Commerce Committee, which is investigating the delay, said in a statement that the negative results added to suspicions that the companies had deliberately sat on their findings from the study, which was known as Enhance. "In light of today's results, which were released nearly two years after the Enhance trial ended, it is easy to conclude that Merck and Schering-Plough intentionally sought to delay the release of this data," Representative Bart Stupak, Democrat of Michigan, said in a statement.

In the trial, patients received either Zocor - an older cholesterol drug - or a combination of Zocor and Zetia, in the pill form known as Vytorin. About 60 percent of patients who take Zetia do so in the Vytorin form, which like Zetia is jointly marketed by Merck and Schering. Worldwide, about one million prescriptions are written for Zetia and Vytorin each week, and about five million people are now taking the drugs worldwide.


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