Two large pharmaceutical companies are being asked to defend themselves against charges that they withheld information that an enhanced cholesterol-lowering drug is no more effective than generic statins.
Sen. Charles Grassley (R-Iowa), ranking member of the Senate Committee on Finance, charged that Merck & Co. and Schering Plough delayed releasing results of a trial study of Vytorin that compared that drug's performance with that of simvastatin, a generic statin that costs less than the brand-name drug.
Vytorin is a combination pill that contains Zetia, a brand-name cholesterol-lowering drug from Schering Plough, and a generic cholesterol medicine from Merck. Vytorin had estimated sales of $5 billion last year, but a presenter at a recent professional meeting said study findings suggest that the drug should not be prescribed.
Grassley said evidence indicates the trial was completed in April 2006, but results were not released until almost two years later, at the recent American College of Cardiology meeting.
He also charged that the companies spent millions recently to continue to market the drug to prescribing physicians, and he charged that the cardiology group received large contributions from the companies, totaling more than $5 million from Merck alone over the past five years.
"Delaying the release of the results from the ENHANCE trial not only affected medical decisions, but also imposed financial burdens on patients as well as the federal government," Grassley said. "Since the ENHANCE trial was completed in 2006, the federal government has paid (Merck and Schering Plough) hundreds of millions of dollars for Vytorin."
Grassley said he's troubled that the companies have been evasive in dealing with queries from John Kastelein, the primary investigator in the study. E-mails from Kastelein, a cardiologist at Academic Medical Center in Amsterdam, warned the companies that it appeared they were "trying to hide something" by not releasing result of the trial.
Grassley said the companies undertook a large marketing effort to convince physicians to continue to prescribe the drug.
"I remain troubled that (Merck and Schering Plough) failed to report any results from the trial until January 2008 while trying over the last year or two to get doctors to switch their patients to Vytorin from other less expensive drugs," he said.
He set an April 14 deadline for responses from the pharmaceutical companies.
Spokespersons from the drug companies denied that the companies are trying to delay the release of the trial's findings.