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Panel widens probe of drug study delay
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More from BusinessTRENTON, N.J. (AP) — A congressional committee has broadened its probe of the delay by drugmakers Merck & Co. and Schering-Plough Corp. in releasing study data about their cholesterol drug Vytorin, saying Internet postings indicate that they knew the results long before releasing them.
The controversial study found that Vytorin wasn't as effective as advertised. The fallout has hammered the stocks of both companies, cut Vytorin sales, triggered potential class-action lawsuits and raised questions about the drugmakers' honesty.
In the latest development, the House Committee on Energy and Commerce has demanded documents from the chief executives of both drugmakers, as well as the Food and Drug Administration and the Webmaster for a Web site called Cafepharma Inc. On the site, anonymous postings by pharmaceutical sales representatives indicate that some reps knew about the results by March 2007.
"These Web site entries are obviously troubling and raise further questions as to whether anyone within Merck or Schering-Plough knew the results of the ENHANCE trial prior to the official release of data," committee letters to the officials state.
The Vytorin study, called ENHANCE, was completed in April 2006, but the companies didn't release partial results until Jan. 14, five weeks after the committee began investigating the delay.
Vytorin combines Schering-Plough's Zetia with Merck's older cholesterol drug Zocor, a former blockbuster available since June 2006 as a generic for about one-third Vytorin's cost. The study found Vytorin was no more effective than the generic at limiting plaque buildup in neck arteries, but did lower cholesterol a bit more.
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