The House Committee on Energy and Commerce has certainly milked this week's Vytorin debacle for publicity. Chairman John Dingell and investigations subchair Bart Stupak sent out a press release almost before the ink was dry on Merck and Schering-Plough's own announcement of the Enhance study results. Now, Newsweek has an interview with Stupak, who's promising hearings within a few weeks.
Stupak leaves no issue untouched in the Q&A, ranging from the expert panel (independent or not?) that advised the companies to change the trial's endpoint (did they or didn't they?) to the companies sitting on the data for almost two years (deliberately hiding bad results or not?) to the Schering execs selling their stock last spring (did they know something or not?) to the timing of the Vytorin marketing blitz. To its credit, Newsweek inserts the companies' responses into the interview, too: endpoints didn't change; results weren't hidden, just hard to interpret; the stock sales followed Schering's own rigorous approval process. Nor does Stupak pull punches on the FDA. "Why aren't they bringing all this out?" Stupak asks. "To get them to do anything after they approve a drug, it's hard."
To prep for the promised hearings, the committee is sending out more letters asking about specific issues, Stupak says, including the stock-option cash-out.
Meanwhile, Merck and Schering-Plough already are facing a lawsuit over Vytorin. Seeking refunds for people who used Vytorin, the suit alleges the companies misrepresented the drug and withheld significant information about it.