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Cholesterol Drug Not Effective in Study
By ALEX BERENSON,
The New York Times
Posted: 2008-01-15 10:54:23
(Jan. 15) - 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, cardiologists said Monday.
Merck and Schering-Plough, which make the drug, Zetia, and a pill that contains it, Vytorin, said Monday morning that Zetia had failed to benefit patients in a two-year trial that ended in April 2006.
The popular cholesterol drug Zetia did not beneift patients in a two-year clinical trial. Merck and Schering-Plough, the makers of the drug, which many patients take in a pill that contains it, Vytorin, said it failed to prevent the buildup of harmful plaque in arteries.
Merck and Schering repeatedly missed their own deadlines for reporting the results, leading cardiologists around the world to wonder what the study would show. At the same time, millions of patients have continued taking Zetia and Vytorin.
The drug companies blamed the complexity of the data for the delay. Now, barely a month after news articles noted the delay and Congress pressured the companies to disclose the study’s findings, the results are out.
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 — although by such a small amount that the finding could have been a result of chance.
Dr. Steven E. Nissen, the chairman of cardiology at the Cleveland Clinic, said the results were “shocking.”
“This is as bad a result for the drug as anybody could have feared,” said Dr. Nissen, a widely published researcher and 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.
Both companies’ shares fell Monday. Sales of the two drugs were $5 billion in 2007, and they are important contributors to Merck’s and Schering’s profits
http://news.aol.com/health/story/_a/cholesterol-drug-not-effective-in-study/20080115091109990001?ncid=NWS00010000000001
By ALEX BERENSON,
The New York Times
Posted: 2008-01-15 10:54:23
(Jan. 15) - 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, cardiologists said Monday.
Merck and Schering-Plough, which make the drug, Zetia, and a pill that contains it, Vytorin, said Monday morning that Zetia had failed to benefit patients in a two-year trial that ended in April 2006.
The popular cholesterol drug Zetia did not beneift patients in a two-year clinical trial. Merck and Schering-Plough, the makers of the drug, which many patients take in a pill that contains it, Vytorin, said it failed to prevent the buildup of harmful plaque in arteries.
Merck and Schering repeatedly missed their own deadlines for reporting the results, leading cardiologists around the world to wonder what the study would show. At the same time, millions of patients have continued taking Zetia and Vytorin.
The drug companies blamed the complexity of the data for the delay. Now, barely a month after news articles noted the delay and Congress pressured the companies to disclose the study’s findings, the results are out.
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 — although by such a small amount that the finding could have been a result of chance.
Dr. Steven E. Nissen, the chairman of cardiology at the Cleveland Clinic, said the results were “shocking.”
“This is as bad a result for the drug as anybody could have feared,” said Dr. Nissen, a widely published researcher and 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.
Both companies’ shares fell Monday. Sales of the two drugs were $5 billion in 2007, and they are important contributors to Merck’s and Schering’s profits
http://news.aol.com/health/story/_a/cholesterol-drug-not-effective-in-study/20080115091109990001?ncid=NWS00010000000001
