NEWS RELEASE

Committee on Energy and Commerce
Rep. John D. Dingell, Chairman

Dingell, Stupak Comment on Results of
New Vytorin Study

Findings Indicate that Vytorin May Increase Risk of Cancer, Death

Reps. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), Chairman of the Oversight and Investigations Subcommittee, today commented on the results of a new study that shows higher rates of cancer and death resulting from cancer in patients treated with Vytorin compared to those taking a placebo.

The Simvastin and Ezetimibe in Aortic Stenosis (SEAS) study for the treatment of aortic stenosis was conducted by Merck and Schering-Plough, manufacturers of Vytorin, a drug used to lower cholesterol.

"The results of this study once again raise questions about whether Vytorin is a safe and effective drug,” said Dingell. “I’m interested in learning what the FDA plans to do about this questionable drug. Our investigation will continue as we explore whether Vytorin may be more dangerous than we had previously been led to believe."

"The ENHANCE study showed that Vytorin was ineffective against cholesterol build-up, and now we're seeing that Vytorin may cause cancer deaths,” said Stupak. “I think it's legitimate to ask at this point whether Merck and Schering-Plough will voluntarily scale back the marketing of this drug and agree not to market Vytorin in direct-to-consumer ads.”

The Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations launched an investigation in December 2007 into the ENHANCE trial, a previous Vytorin study conducted by Merck and Schering-Plough. The investigation was launched following concerns that, although the ENHANCE trial ended in April 2006, the results were not released until January 2008. Merck and Schering-Plough decided to pull the television advertising for Vytorin after they released the study results, which revealed that Vytorin is no more effective in reducing cholesterol than a high dose of one of its generically available components alone.

Click here for more information about the Committee investigation.

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