The FDA’s David Graham, who testified before Congress about
the dangers of the arthritis drug Vioxx, hasn’t 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 wasn’t my intention
to be a whistle-blower. All I wanted to do was a study on Vioxx.”

—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

“I’ve been contacted by several senators and by several members
of the House of Representatives expressing their support for what I’ve done.
But this is an incredibly political process. I’m a scientist, not a bureaucrat
or a politician, and I’m sort of trapped in the hurricane.”

—Graham, ABC’s 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. I’m 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 don’t
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 we’re concerned about is the sort of hysterical charges
that come out, that aren’t based on reality.”

—Dr. Steven Galson, acting director of FDA’s Center for Drug
Evaluation, NBC’s 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 didn’t.”

—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 CDER’s standard, you wouldn’t 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 CDER’s 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 Crawford’s quote, USA Today, November

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