Merck and Schering-Plough concealed data in clinical trials

Congressmen John Dingell (D-MI) and Bart Stupak (D-MI) say that Merck and Schering-Plough concealed or manipulated clinical trial data for Vytorin. Trial results showed that Vytorin was no more effective than the cheap, generic versions.“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.

The House Energy and Commerce Committee wants more information about the so-called independent panel formed to review the Vytorin trial data, the study’s Data Safety Monitoring Board, stock sales by Schering-Plough execs and the amount of money spent on Vytorin by the Centers for Medicare and Medicaid Services.

Release of the Vytorin data was delayed almost two years and the primary endpoint was briefly changed without the consent of the lead investigator. “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."

The investigation is also focusing on the heavy advertising for Vytorin.