FDA Insider: Rx Risks Suppressed

(CBS)  The Food and Drug Administration announced Tuesday it is setting up an independent board to monitor the safety of prescription drugs.

This follows a number of cases in which drugs the agency said were safe ... turned out not to be.

The new FDA monitoring board is a direct response to all the heat the Food and Drug Administration's gotten for supposedly ignoring, even suppressing, its own scientists' safety concerns. The independent FDA drug safety board will have one main priority: to expose dangers of drugs once they hit the market.

As CBS News Correspondent Sharyl Attkisson reports, it's an area where critics say the FDA too often fails.

But even as the new safety board was being announced, more possible drug dangers are being suppressed at the FDA, at least according to FDA scientist David Graham.

Graham, the associate director for the FDA's Office of Drug Safety, blew the whistle on his bosses before Congress last fall for silencing him and his colleagues on the risks of Vioxx and other drugs. At issue now is what managers will let him tell at the FDA advisors meeting this week about the heart risks of popular painkillers.

He has told FDA management that he has important findings that ought to be presented, but, as Graham says, he's been instructed to keep quiet.

"What they have told me is that I may not," says Graham. "They've told me that I dare not.

"They've told me that 'you will not.'"

What FDA advisors "will not" hear about is the new study Graham just finished with a doctor at Stanford University - the largest of its kind. It covers not only Vioxx, but also alternatives like Celebrex and Mobic and reportedly exposes new heart risks.

The FDA wouldn't agree to an interview, but told CBS News that Graham can present his study if he wants to. Graham believes if he does, he'll be fired for insubordination.

Which raises the question if an FDA scientist has important information, why should he be asking to present it, shouldn't his bosses be compelling him to present it?

"You would think that if the FDA were working for the public and were interested in drug safety that that would be their exact reaction,'' says Graham.

It's just one reason why FDA critics say, even with an independent drug safety committee, there's more work to be done to reform the FDA. One senator is drafting legislation to give Graham's drug safety office at the FDA more independence and authority.