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Reps. Dingell, Stupak to Continue ENHANCE Trial Investigation

Study Results Raise Questions, Show No Benefit from Brand-Name Drug

WASHINGTON, Jan. 14, 2008– Rep. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Rep. Bart Stupak (D-MI), Chairman of the Subcommittee on Oversight and Investigations, today responded to Merck and Schering-Plough’s release of the ENHANCE study results by affirming that their investigation into the ENHANCE trial would continue. 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. Additional questions had been raised by the fact that Merck and Schering-Plough did not register the clinical trial in a timely manner. Furthermore, Merck and Schering-Plough attempted to change the study endpoints, and thus the study results, prior to the public release of the results. According to the companies, this change was recommended by an unnamed advisory panel.

“Today’s announcement that the ENHANCE study failed to find any positive benefit from the addition of Zetia to a common, inexpensive, generic therapy raises concerns that attempts were made to mask the minimal value of this new drug. Additionally, Merck and Schering-Plough’s delay in releasing study results, as well as their attempt to manipulate the data is, quite frankly, suspicious,” said Dingell. “Heart disease is a serious and growing national problem. American consumers and their doctors should not have had to wait nearly two years for this information. Why did Merck and Schering-Plough go to great lengths to delay the study results? Why did they attempt to manipulate the data? We will continue our investigation until these questions are answered.”

“In light of today’s results, which were released nearly two years after the ENHANCE trial ended, it is easy to conclude that Merck and Schering-Plough intentionally sought to delay the release of this data,” said Stupak. “It’s currently unclear whether these companies knew that adding a new expensive drug accomplished nothing more than an established, cheaper, generic. But it is clear that our investigation is far from over.

Contact: Jodi Seth or Brin Frazier, 202-225-5735

Posted: January 2008

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