Dingell, Stupak Raise Concerns, Questions on ENHANCE Trial
Call on Merck, Schering-Plough and FDA to Provide Information
Washington, D.C. – Rep. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce, Rep. Bart Stupak (D-MI), Chairman of the Oversight and Investigations Subcommittee today wrote to Andrew von Eschenbach, Commissioner of the Food and Drug Administration (FDA), and to the CEOs of Schering-Plough Corporation and Merck & Co, Inc., requesting information about the ENHANCE study trial. 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 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 results were recently released on January 14, 2008.