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What The Drug Companies Are Not Telling You and The Vioxx Scandal

 

DR. DAVID GRAHAM IS LOSING WEIGHT AGAIN. His wife noticed first, then his colleagues at the Food and Drug Administration.

Graham is a skinny man, and when he drops weight, his cheekbones seem to sit higher on his face. His striped cotton shirts, the frumpy uniform of a government scientist, hang more loosely on his narrow frame. But he isn't eating, and no wonder:

Graham, the scientist who brought the Vioxx scandal to the nation's attention, feels like a marked man.

"I'm no longer welcome," he says, sitting in a Rockville , Maryland , coffee shop in early February. He has just left another frustrating day at work, where his boss warned him not to disclose new safety findings about a popular class of painkillers called Cox-2 inhibitors.

In a few minutes, he is due at his son's Boy Scout meeting, but all he can talk about now is the exhaustion of working in a drug-safety system in turmoil. "I'm hoping things will calm down, but I don't think the FDA will let that happen," he says. "How do you get off the merry-go-round?"

In August 2004, Graham told his supervisors that, in light of his research, high-dose prescriptions of the painkiller Vioxx, which appeared to triple heart attack rates, should be banned. They told him to be quiet. Their reasoning was circular:

That's not the FDA's position; you work here; it can't be yours. Dr. John Jenkins, the FDA director of new drugs, argued that because Graham's findings didn't replicate the drug's warning label, Graham shouldn't be raising the warning. Another supervisor, Anne Trontrell, called Graham's position "particularly problematic since FDA funded this study." Days after

Graham's pronouncement, the agency approved Vioxx for use in children.

But Graham was right. The following month, Merck pulled Vioxx from the market after its own research found that the drug, even when taken at low dosages, doubled the risk of heart attack. The announcement provided Graham no vindication. With a scandal on the horizon, the FDA brass now saw him as a danger. They couldn't silence the message, so they tried to take out the messenger.

Dr. Steven K. Galson, the acting director of the drug-evaluation division at the FDA, told reporters that Graham's work "constitutes junk science." Then he sent an email to an editor at the prestigious British medical journal The Lancet, questioning the "integrity" of Graham's data-a suspicion that proved baseless. The FDA's acting commissioner, Dr. Lester

Crawford, criticized Graham for evading the agency's "long-established peer review and clearance process." Another official made calls to at least one Senate staffer, disparaging Graham personally and professionally.

Eventually, he was heard. In November he went before the Senate Finance Committee hearing on Vioxx. Gaunt (he'd lost 12 pounds over three months) but very lucid, Graham took his place before a bank of cameras, wearing his only sport coat, a 20-year-old blue blazer with brass buttons.

He explained his conclusion that patients taking high doses of Vioxx were suffering heart attacks. "The estimates range from 88,000 to 139,000 Americans," he said. "Of these, 30 to 40 percent probably died. For the survivors, their lives were changed forever." According to the top end of those projections, the toll

Vioxx had already taken was comparable to the number of Americans killed in Vietnam . "The FDA, as currently configured,"

Graham told the committee, "is incapable of protecting America against another Vioxx. We are virtually defenseless."

But three months later, as Graham sips iced tea in a Rockville café, what the drug companies are not telling you is that the FDA is again trying to suppress his research, this time on the effects of pain medications similar to Vioxx. "I think we've already articulated our preference," his supervisor,

Dr. Paul Seligman, wrote him in a terse email. The agency doesn't want Graham presenting his latest research to scientists who will be meeting in a few days to discuss the drugs.

David Graham is headstrong, but not insubordinate. He cannot afford to lose his job. His family has just moved to a new house. His wife, Nancy, stopped working as a lawyer so she could home school their six children. Really, though, he has no more time to sit here worrying. The Boy Scouts are competing for their merit badges this evening. He finishes his iced tea.

"I've made a commitment," he says, before walking out the door. "I'll weigh myself this evening."

We live in the pharmaceutical era of medicine, a time of tablet-sized miracles and blockbuster serums. More than 70 new drugs are approved every year, adding to the thousands for which American doctors already write some 3 billion annual prescriptions.

The medications prolong countless lives and cause millions of harmful side effects. For most patients, the benefits far outweigh the dangers. An aging man will risk diarrhea to restore his virility. A cancer patient will lose her hair in the hope that chemotherapy will save her life.

FDA safety officers like Graham spend their lives searching out the other type of pills, the unexpected killers that harm patients after the FDA has approved them.

 

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