We Have Ways of Making You Not Talk
The FDAs David Graham, who testified before Congress about the dangers of the arthritis drug Vioxx, hasnt had a lot of support from his bosses. In fact, he expects to be transferred out of his job as associate director for science and medicine in the Office of Drug Safety in retaliation for speaking out. Despite enormous pressure from the FDA to keep quiet, Graham has voiced his concerns with eloquence, honesty and, at times, even poetry.
"Hope springs eternal in the human heart, I believe in the work. I have a hope that somehow or another, that some truth will get out."
David Graham, Associated Press, November 24
"FDA made me into a whistle-blower. It wasnt my intention to be a whistle-blower. All I wanted to do was a study on Vioxx."
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Graham, USA Today, November 30
"A senior manager from my office labeled our Vioxx study a in quotes scientific rumor. Eight days later, Merck pulled Vioxx from the market, and jetliners stopped dropping from the sky."
Graham, Senate Finance Committee Hearing, November 18
"Ive been contacted by several senators and by several members of the House of Representatives expressing their support for what Ive done. But this is an incredibly political process. Im a scientist, not a bureaucrat or a politician, and Im sort of trapped in the hurricane."
Graham, ABCs Good Morning America, November 24
SEN. CHARLES GRASSLEY: Is there any truth to the allegation that you will be leaving the FDA to make your fortune as an expert witness on safety drug safety?
DOCTOR DAVID GRAHAM: Oh, golly. Im sure FDA wishes that I would.
Senate Finance Committee Hearing, November 18
DOCTOR JANET WOODCOCK, FDA Deputy Commissioner: We feel that the drug development system in the United States is the gold standard. And I dont think you could find a drug development expert in this country who would disagree with that.
TED KOPPEL: Well, clearly you got one. And he works for you.
WOODCOCK: I said a drug development expert.
Nightline, November 23
"What were concerned about is the sort of hysterical charges that come out, that arent based on reality."
Dr. Steven Galson, acting director of FDAs Center for Drug Evaluation, NBCs Today, November 26.
"The response from senior management in my office . . . was . . . stressful. I was pressured to change my conclusions and recommendations. One drug safety manager recommended that I should be barred from presenting the poster at the meeting, and also noted that Merck needed to know our study results. So I guess Merck needed to know the results, but the public didnt."
Graham, before Senate Finance Committee, November 18
"Vioxx is a terrible tragedy and a profound regulatory failure. I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless."
Graham, Senate Finance Committee, November 18
"When it comes to safety, the Office of New Drugs paradigm of 95 percent certainty prevails. Under this paradigm, a drug is safe until you can show that with 95 percent or greater certainty it is not safe. . . . If the weatherman says there is an 80 percent chance of rain, most people would bring an umbrella. Using CDERs standard, you wouldnt bring an umbrella until the weatherman said there was a 95 percent or greater chance.
And I have a second analogy. Imagine that you have a pistol with a barrel having 100 chambers. Now, randomly place 95 bullets into those chambers. The gun represents a drug, and the bullets represent the probability, the certainty of a serious drug safety problem. Using CDERs standard, only when you have 95 bullets or more in the gun would CDER conclude that the gun is loaded, that is, that there are drug safety problems with that drug. Now, remove five bullets from the chamber. Now, we now have 90 bullets. Because there is only a 90 percent chance that when I pull the trigger a bullet will fire, CDER would conclude that the gun is not loaded, that is, the drug is safe."
Graham, Senate Finance Committee, November 18
"FDA encourages open and vigorous internal debate about the often difficult scientific questions it routinely faces."
Acting FDA commissioner Lester Crawford, explaining that Graham voluntarily revised his Vioxx conclusions before a meeting this summer in France
"When you live in a climate of fear, retaliation and intimidation, no decision that one makes is entirely voluntary."
Graham, responding to Crawfords quote, USA Today, November 30
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