WASHINGTON (Reuters) - Anonymous messages posted on a Web site raise questions about the handling of data on a Merck & Co Inc <MRK.N> and Schering-Plough Corp <SGP.N> cholesterol drug, two House of Representatives Democrats said on Monday.
By Lisa Richwine
WASHINGTON (Reuters) - Anonymous messages posted on a Web site raise questions about the handling of data on a Merck & Co Inc <MRK.N> and Schering-Plough Corp <SGP.N> cholesterol drug, two House of Representatives Democrats said on Monday.
The drugmakers have been criticized for delaying the release of results from a study called Enhance. That trial found the cholesterol pill Vytorin worked no better than a generic at preventing plaque build-up in neck arteries.
Top Democrats on the House of Representatives Energy and Commerce Committee said on Monday they had "recently learned" of and were examining anonymous messages posted in 2007 on a Web site for pharmaceutical sales representatives called Cafepharma.com. The Enhance study concluded in April 2006 but results were not released until January 2008.
!ADVERTISEMENT!"These Web site entries are obviously troubling and raise again the question of whether anyone within Merck or Schering-Plough knew the results of the Enhance trial prior to the official release," Michigan Reps. John Dingell and Bart Stupak said in a letter to the companies.
Dingell chairs the committee, while Stupak heads its oversight and investigations subcommittee.
According to the lawmakers, one March 2007 entry on the Web site states "have a buddy at (Schering-Plough Research Institute). He says that the study is a bust. Adding Zetia to already maxed out statin is useless." Another from June 2007 said "heard it crashed and burned!"
Zetia is one of the ingredients in Vytorin, which also contains the statin drug Zocor.
Another November 2007 entry said "word of mouth from investigators involved in running the trial is that it is a negative study," according to the letter.
In the letter, the congressmen asked Merck and Schering-Plough explain when and how officials became aware of the Cafepharma postings and what they have done or plan to do to probe the source of the entries. They also requested any records relating to the postings.
Merck spokesman Christopher Garland said the company would cooperate with the request, adding Merck had "acted with integrity and in good faith in this clinical trial" and "stands by the safety and efficacy profiles of both Zetia and Vytorin."
Lee Davies, a spokesman for the Merck and Schering-Plough joint venture that sells Vytorin, said the companies were in the process of responding to all the lawmakers' requests for information in the Vytorin probe and would answer the newest letter.
The lawmakers also sent letters requesting information about who may have posted the messages to Cafepharma.com and SoftLayer Technologies Inc, which they said operates the Web site. Officials at those companies could not immediately be reached for comment.
In addition, Dingell and Stupak asked the FDA for records about the Enhance study protocol, health problems reported with Vytorin, and other information. FDA spokeswoman Susan Cruzan said the FDA would review the letter and respond.
