Merck Saw Vioxx Risk While FDA Hid Data: GrassleyOct 7, 2004 | Investor's Business Daily
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The U.S. Food and Drug Administration tried to cover up a study done by an FDA employee that showed a cardiac risk linked to Merck's (MRK) arthritis drug Vioxx, Sen. Charles Grassley said Thursday.
"It seems that while Merck was taking a fresh look at its clinical data in search of trouble, the [FDA] was challenging its own researcher," said Grassley, R-Iowa, chairman of the Senate Finance Committee.
The committee is investigating how the FDA reviews drugs for safety. The investigation comes after disclosure of health risks associated with Vioxx and with the use of anti-depressants in children.
In a statement, Grassley said that his committee found that FDA staffer David Graham led a study into Vioxx's cardiac risks, but that Graham was threatened and intimidated into keeping his findings quiet.
After failing to persuade Graham to water down his study's results, Grassley charged, Graham's supervisor wrote that Merck had to be advised of the newly discovered safety risk before it became public.
Merck's long-term study of Vioxx for the drug's use in treating colon polyps was ultimately halted when an increased cardiac risk was found. The company pulled its drug from the market last week, sending the firm's stock into a tailspin.
FDA officials were unavailable for comment.