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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?

To: Stephen O who wrote (8658)	11/24/2004 7:11:08 PM
From: Stephen O	Read Replies (1) \| Respond to of 9523

U.S. FDA's Graham Says He Was `Forced' to Become Whistleblower By Kerry Dooley Nov. 23 (Bloomberg) -- U.S. Food and Drug Administration doctor David Graham said circumstances at the agency ``forced'' him to become a whistleblower to protect consumers from dangerous drugs. Less than a week after Graham told a Senate Finance Committee of his concerns about the FDA, he appeared on ABC's ``Nightline'' program. Graham told the Senate panel that his research has led him to estimate that Merck & Co.'s Vioxx hurt 88,000 to 139,000 Americans, with 30 percent to 40 percent of them dying. The Vioxx withdrawal, the biggest for a prescription drug, is leading Congress to take a closer look at the FDA. The House Energy and Commerce Committee today said it will examine the agency's monitoring of Vioxx. The committee, which oversees the FDA, already was examining whether the agency delayed telling the public about risks of antidepressants. ``We have a system that is biased toward approving drugs almost regardless of the safety risks,'' Graham said in his ``Nightline'' interview. ``Any reason will be looked for to approve a drug, unless there's an overwhelming safety reason not to approve a drug.'' 10 Recalls Graham is a 20-year veteran of the FDA, where his work has contributed to the recalling of 10 medicines. A 1979 graduate of Johns Hopkins School of Medicine, Graham trained in medicine at Yale University and the University of Pennsylvania. About 20 million Americans tried Vioxx before Merck took the drug off the market. Merck's three-year study of Vioxx for fighting colon growths found that 15 per 1,000 patients taking the drug had heart attacks or strokes, compared with 7.5 for those taking a placebo. The FDA could have acted sooner to warn the public about Vioxx, Graham said. The agency should have acted after Merck released an earlier study, known as Vigor, that tied Vioxx to heart risk. ``If the public was the client and not industry, the high dose of Vioxx would have been banned from the market in 2000 when the results of the Vigor study were known,'' Graham said. The FDA's management has defended its handling of Vioxx, which the agency cleared in 1999. ``We have to recognize that all drugs have side effects, and some drugs have very rare side effects that are not going to be found until the drugs are on the market for awhile,'' Acting Deputy FDA Commissioner for Operations Janet Woodcock said on ``Nightline.'' ``That was the case with Vioxx.'' The FDA has said it will hold a meeting next year to review the safety of drugs similar to Vioxx. --Editor: Todd.