House widens probe into cholesterol drug
TRENTON, N.J. - A House committee investigating the safety and effectiveness of the popular cholesterol drug Vytorin and one of its components is turning up the heat on the drug's makers.
The chief executives of Merck & Co. and Schering-Plough Corp. already were facing a deadline of yesterday to produce extensive data on a clinical study called SEAS that indicated a possible cancer risk from Vytorin, which combines Merck's Zocor, a statin, and Schering-Plough's Zetia, a different type of cholesterol fighter that is the component under suspicion.
Now the House Energy and Commerce Committee wants answers to more questions and is asking the companies to let committee staff question the key statistics expert who has analyzed data on cancer cases and deaths in the SEAS study and two other ongoing Vytorin studies.
In a letter to Merck CEO Richard Clark and Schering-Plough CEO Fred Hassan this week, the committee directs the companies to answer questions about the analysis and a report on it by statistics expert, Sir Richard Peto, codirector of the Oxford University Clinical Trials Service Unit.
The letter states the committee had expected "a complete assessment of Vytorin's association with cancer in the SEAS study," but only got a five-page report, relayed by the Food and Drug Administration on Aug. 21, that contained little more information than what Peto already had released publicly.
"We are concerned that an esteemed scientific consultant to Merck and Schering-Plough may have generated a secret report to FDA," wrote the committee chairman, Representatives John Dingell, and Bart Stupak, the chairman of its Subcommittee on Oversight and Investigations. Both men are Democrats from Michigan.
FDA spokeswoman Susan Cruzan said she's not aware of any secret report.