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November 24, 2004

Is the FDA Smearing a Whistleblower?

I wish I had blogged this earlier! Less than a week ago, the Washington Post reported on the testimony of David Graham, a drug safety official at the FDA. Now, most of the time, agency testimony is not at all dramatic. Everyone knows what is going to be said before it is said. Trust me on this, I've testified half a dozen times in Congress. Graham bucked the trend:

A veteran Food and Drug Administration safety officer said yesterday at a Senate hearing on the abrupt recall of the arthritis drug Vioxx that five other widely used drugs should either be withdrawn or more sharply restricted because they have dangerous side effects.
Describing the agency he works for as incapable of stopping dangerous drugs from entering and staying on the market, David J. Graham, associate director of the Office of Drug Safety, told the senators that the FDA's role in reviewing and approving new drugs sometimes conflicts with its duty to address safety issues.

Asked by Sen. Jeff Bingaman (D-N.M.) to identify the five drugs, Graham hesitated and then named them to the startled listeners: the popular cholesterol-lowering drug Crestor, the weight-loss drug Meridia, the painkiller Bextra, the acne medication Accutane and the asthma medication Serevent.

Each poses different issues, Graham said in response to senators' questions, but all require more aggressive FDA action.

Damn! This never happens. But retaliation for this type of speech happens all the time. Today's Washington Post describes underhanded attempts at the FDA to undermine Graham:

Managers at the Food and Drug Administration last month anonymously called a group that protects whistle-blowers in an attempt to discredit an outspoken agency safety officer who was challenging the FDA's drug safety policies, the legal director of the whistle-blower group said yesterday.
Tom Devine of the nonprofit Government Accountability Project (GAP) said the anonymous callers did not identify themselves but he is "100 percent positive" they were managers at the FDA because of their phone numbers and other identifying information. He said he initially took the callers' concerns seriously but later came to see the calls as an effort to smear the whistle-blower, Associate Director David J. Graham of the Office of Drug Safety...

Although the FDA initially sharply criticized Graham's testimony -- one top official called him "irresponsible" and a practitioner of "junk science" -- the agency yesterday tightened the restrictions on one of the five drugs Graham had criticized, the acne medication Accutane...

"The calls came under the guise of being anonymous whistle-blowers," Devine said. "They were clearly working together and shared allegations -- mostly that Dr. Graham's research was unreliable and that there were serious questions of possible scientific misconduct with his study. They said Graham wouldn't address their concerns, and that he was a demagogue and a bully."...

In that account, Devine said the FDA was "employing a classic law of whistleblower reprisal -- the smokescreen syndrome -- which shifts the spotlight from the message to the messenger. The agency attempted to discredit Dr. Graham rather than provide any scientific evidence contradicting his conclusions."

Posted by chris at November 24, 2004 10:04 AM

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