Chain Drug Review - Congressional committee wants to see Vytorin analysis
WASHINGTON — The House Energy and Commerce Committee wants the Food and Drug Administration to turn over the results of an analysis about the potential links between cancer and the cholesterol drug Vytorin, which is sold jointly by Merck & Co. and Schering-Plough Corp.
A recent study indicated that Vytorin not only failed to help people with heart value disease avoid further problems but also appeared to increase their risk of cancer.
The study, known as SEAS, revealed that slightly higher incidents of cancer deaths were seen in those taking Vytorin–39, versus 23 on a placebo.
Scientists who conducted the study cautioned against panic, noting that even well-designed clinical trials sometimes produce erratic results.
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But other scientists and cardiologists say the study cannot be so easily dismissed.
Both Vytorin and Zetia, a companion drug, are prescribed monthly to nearly 3 million people and are among the world’s top-selling medications.
The drugs had combined sales of $5 billion in 2007.
The results of the study heighten concerns about the safety and effectiveness of Vytorin, according to Dr. Steven Nissen, a former president of the American College of Cardiology.
Six months ago a clinical trial of Vytorin failed to show that the medication helped patients, which led to a panel of cardiologists recommending that Vytorin and Zetia be used only as a last resort. Since that time sales of both drugs have plummeted, with analysts saying the SEAS study represents a worst-case scenario for Merck and Schering.
“We believe the commercial downside of a negative study is likely greater than the upside on positive results,” says Steve Scala, an analyst at Cowen Investment Bank.
For its part, Merck says its long-term financial earnings remain un clear after the result of the study.
Meanwhile, Fred Hassan, Schering’s chief financial officer and chairman, says the company’s strong stable of drugs in late-phase development would help supplement the “cholesterol challenge we’re facing.”
Vytorin is a single pill that combines Zocor (simvastatin) and Zetia (ezetimibe), two cholesterol-lowering medications. Both are also available as single pills.
Decades of research has revealed that statins reduce the risk of heart attacks and do not raise the risk of cancer, but the new safety concerns center around ezetimibe.
About 2 million prescriptions a month are written for ezetimibe–either independently as Zetia or in the Vytorin combination pill–in the United States alone. The SEAS trial involved nearly 1,900 patients whose heart valves were partially blocked. The patients were given either Vytorin or a placebo pill.
“No significant difference was observed between the treatment groups for the combined primary endpoint,” said Dr. Terje Pedersen, the principal investigator for the study.
The primary endpoint is the result that scientists hope to prove when running clinical trials.
However, a patient in the SEAS trail taking Vytorin had a sharply higher risk of developing cancer.
The analysis of potential links between cancer and Vytorin was given to the FDA but not to the House Commerce Committee, which has been investing the safety of prescription drugs and has reviewed the marketing of Vytorin.
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COPYRIGHT 2008 Gale, Cengage Learning
