04/14/2008 (10:01 am)
Lawmakers question makers on key Vytorin meeting
Two U.S. Democrats said on Friday their investigation had raised questions about how Merck & Co Inc (MRK.N: Quote, Profile, Research) and Schering-Plough Corp (SGP.N: Quote, Profile, Research) documented a key meeting about a controversial study of their Vytorin cholesterol drug.
House of Representatives Energy and Commerce Committee Chairman John Dingell and Rep. Bart Stupak said company documents showed minutes from a November meeting of outside experts reviewing the study were “created after the fact.”
The documents showed one of the experts complained the minutes did not reflect all the opinions expressed, although he said a later summary did.
A company spokeswoman said participants in the meeting had been told no minutes would be produced, so none were — until the Food and Drug Administration later requested them.
Dingell and Stupak, chairman of the oversight and investigations subcommittee, are probing why the companies did not release the study findings until 20 months after it ended.
The study showed Vytorin was no better than a cheaper generic drug at reducing plaque in neck arteries.
Vytorin, which had sales of $5 billion a year, accounts for the majority of Schering-Plough’s profits cash advance. Shares of Merck and Schering-Plough, which sell Vytorin through a joint venture, have fallen sharply since the results of the study, named Enhance, were released in January.
Dingell and Stupak, both Michigan Democrats, said they “continue to have serious concerns regarding the conduct and reporting” of the Enhance trial.
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