Whistleblower at FDA steps into the spotlight

Scientist: The reluctant celebrity says he has put his job on the line with his warnings about drug safety.

December 06, 2004|By David Kohn | David Kohn,SUN STAFF

Lately, strangers have been coming up to David Graham, wanting to shake his hand and thank him. That wouldn't be unusual if he were a rock star or an actor. But he's neither.

He's a career government scientist, a self-described "big-time introvert" who likes poetry and hiking.

Over the past few weeks, the 50-year-old epidemiologist has become an accidental celebrity. He has testified before Congress and appeared on the CBS Evening News, Nightline, and the front pages of newspapers around the country.

"When I went up to New York for Good Morning America, people stopped me on the street," he says, shaking his head. "It was amazing."

Graham, a safety officer for the Food and Drug Administration, earned his moment in the spotlight by repeatedly accusing his bosses of failing to guarantee the safety of America's drugs.

He says the agency ignored mounting evidence that Vioxx, a popular anti-inflammatory, multiplied the risk of heart attacks at least three-fold. As a result, he and others say, the drug may have caused up to 55,000 unnecessary heart attack deaths between its approval in 1999 and Merck's decision to pull it from the market Sept. 30.

And Graham says the FDA continues to allow other risky drugs to be sold.

In return, his bosses have ridiculed his findings and labeled his work "junk science." Graham says the FDA is trying to keep him from publishing his findings on Vioxx, and wants to transfer him out of its drug safety division. In the nearly three weeks since his Senate testimony, he says, none of his supervisors has so much as spoken to him.

As Graham sees it, the enormity of the Vioxx debacle has been obscured, because the damage occurred so gradually.

"What we have here with Vioxx is a tragedy that was played out day in and day out for five years, one patient at a time," he said.

He worries that without stark images to spur public anger, the FDA and the pharmaceutical industry will rebuff attempts at reform. And if the current system continues unchanged, he argues, Vioxx won't be the last drug safety disaster.

"The longer the delay, the easier it's going to be to forget," he says. "Then it becomes numbers, and it just gets swept under the rug. But this is real, and it's immense."

The conflict has taken its toll. Thin to start with, Graham has dropped about 10 pounds since the Vioxx controversy began two months ago. His cheekbones seem ready to burst through his skin, and his clothes balloon around his limbs.

Still, Graham seems energized. With his pale blue eyes and short, graying hair, he resembles a priest in an old movie, the resolute character who persuades the murderer to let the hostage go and give himself up.

Despite his recent renown, Graham remains profoundly unassuming. He doesn't own a suit, and has only one sports coat, which he bought 20 years ago. He wore it to his Senate appearance.

Over tea at a mall restaurant in suburban Washington, he talks passionately about drug safety, and his unlikely path from anonymous epidemiologist to national whistleblower.

Raised in northwest New Jersey, he is the son of a corporate businessman and a homemaker. He graduated from Johns Hopkins Medical School in 1979 and trained to be a neurologist. But during his residency, he realized that while he enjoyed helping patients, he was bored making the same diagnoses day after day.

In search of more intellectual excitement, he decided to become an epidemiologist, and returned to Hopkins for a public-health degree. He has spent the past 20 years at the FDA, working on drug safety issues.

Despite recent events, Graham still enjoys his work. Now the associate director for science and medicine in the Office of Drug Safety, he studies a range of drugs and advises colleagues on their research.

He sees his job as more than solving epidemiological puzzles. "To me, the public is my patient," he says. "I'm trying to do everything that I can for that patient."

During his tenure at the FDA, Graham has helped recall 10 hazardous drugs, including Vioxx and Lotronex, a medicine for irritable bowel syndrome that turned out to increase the risk of serious intestinal inflammation (It's now back on the market, but for limited use).

Colleagues praise Graham's analytical skills, and say he doesn't speak out unless he has solid evidence.

"He's got a very good track record," says Paul Stolley, a University of Maryland epidemiologist who worked in the FDA's drug safety office in 2000, and knows Graham well. "He's no hothead. He's doing this because he thinks these drugs are dangerous and he's going to save lives."

For Graham, the issue is clear: His employer is falling down on the job. He and other critics says the FDA is much too cautious about recalling potentially unsafe drugs.

"They demand overwhelming evidence that a drug is harmful before they will act," he says. "They've given the drugs a free pass on safety. "

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