NEWS RELEASE

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

Dingell, Stupak Comment on Decision to
Pull Vytorin Ads

Say While Decision is Important First Step, Committee
Investigation will Continue

Washington, D.C. – Rep. John D. Dingell (D-MI), the Chairman of the Committee on Energy and Commerce, and Rep. Bart Stupak (D-MI), the Chairman of the Oversight and Investigations Subcommittee, commented today on the decision by Merck & Co. and Schering-Plough to pull television advertising for the drug Vytorin. The lawmakers said the decision to pull the television advertising was an appropriate first step after study data revealed that the cholesterol drug is no more effective than a high dose of its generically available components.

“I am pleased that our investigation prompted these companies to pull advertising for Vytorin,” Dingell said. “However, our investigation is far from over and stopping this advertising by no means excuses these companies’ behavior.”

Stupak added that the Committee’s investigation is in its early stages and that important questions remain unanswered.

“Important questions about Vytorin, the marketing of this drug and the ENHANCE study still need to be answered,” Stupak said. “Did these companies know the results ahead of time? Why did they change the endpoints for the study? Did they escalate their marketing efforts because they knew the drug did not work? Did executives sell stock based upon the study's result? Our Subcommittee will continue pursuing answers to these questions.”

The Committee on Energy and Commerce began an investigation into the ENHANCE trial on December 11, 2007. The investigation was launched following concerns that, although the ENHANCE trial ended in April 2006, the data had not yet been released. The ENHANCE study compared the brand-name drug Vytorin to the generic drug simvastatin, both of which are used to treat patients with high-cholesterol. The study results show that Vytorin, which is a combination of Zetia and the generic simvastatin, resulted in no significant difference when compared to simvastatin alone.

The results were released on January 14, 2008. Since then, Dingell and Stupak requested additional information about Vytorin and the ENHANCE study trial from Schering-Plough Corporation and Merck & Co, Inc., the Food and Drug Administration (FDA), and the Centers for Medicare and Medicaid Services (CMS).

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