Quote of note:

In his testimony, Graham said the FDA's Office of New Drugs unrealistically maintains a drug is safe unless reviewers establish with 95 percent certainty that it is not.

That rule does not protect consumers, Graham told the Senate committee. "What it does is it protects the drug," he said.

FDA reviewer says five drugs now on market are so worrisome they deserve another look
- DIEDTRA HENDERSON, AP Science Writer
Thursday, November 18, 2004
(11-18) 17:31 PST WASHINGTON (AP) --

At least five medications now sold to consumers pose such risks that their sale should be limited or stopped, said a government drug reviewer who raised safety questions earlier about the arthritis drug Vioxx.

In testimony Thursday before the Senate Finance Committee, Food and Drug Administration reviewer David Graham cited Meridia, Crestor, Accutane, Bextra and Serevent. Drug makers defended the use and safety of their products.

Graham contended the country is "virtually defenseless" against a repeat of the Vioxx debacle. Dr. Steven Galson of the FDA rejected that comment as having "no basis in fact."

Merck & Co. pulled Vioxx from the market on Sept. 30 after a study indicated the popular painkiller doubled the risk of heart attacks and stroke when taken for longer than 18 months.

The committee chairman, Sen. Charles Grassley, suggested an independent board of drug safety may be needed to ensure the safety of medications after FDA approval. An "awful lot of red flags" were raised before Vioxx was withdrawn, said Grassley, R-Iowa., and the agency disdained, rather than listened to, its own reviewers.

Graham contended that FDA has an inherent conflict of interest that triggers "denial, rejection and heat" when safety questions emerge about products it has approved.

…Grassley accused the FDA of attempting to intimidate Graham. Sen. Jeff Bingaman, D-N.M., urged President Bush to name a new leader at the FDA, where Lester Crawford is the acting commissioner.

Graham said he fears continued intimidation.

"I was frightened before," he told reporters after the hearing. "Senior management at the FDA did everything in their power to intimidate me prior to my testimony," he said.