Resources for Food and Drug Administration (FDA)

Was The FDA Given A Secret Vytorin Report?

www.pharmalot.com

Two weeks ago, the House Energy & Commerce Committee stepped up its probe of the controversial cholesterol pill by demanding Merck and Schering-Plough, which jointly market Vytorin, turn over documents relating to the SEAS trial and its analysis. This trial, you may recall, turned up an unexpected link to cancer and cancer-related deaths (back story).

In particular, the committee wanted the analysis by Oxford University’s Richard Peto, who is running one of two larger Vytorin trials and maintains the cancer findings are a bizarre fluke. His report, which the drugmakers insist they did not underwrite, was submitted to the FDA. But the drugmakers refused to provide the report without “assurances” it wouldn’t be released to the public. Instead, the committee was told to get the report from the FDA, since Peto provided a copy to the agency.

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