Scientist, father, husband and scoutmaster David Graham recently added another job to his résumé. Unlike the others, though, it's one he never sought.

©Gerald Herbert/AP
Graham: "FDA made me into a whistle-blower. It wasn't my intention to be a whistle-blower."

"FDA made me into a whistle-blower," Graham, a scientist in the Food and Drug Administration's Office of Drug Safety, said in a three-hour interview Saturday at a coffee shop near his home. "It wasn't my intention to be a whistle-blower.

"All I wanted to do was a study on Vioxx."

As a result of that study, Graham - who for the most part has worked in the relative obscurity typical of an FDA scientist - has appeared recently on Nightline, CNN and Good Morning America. His photo has run in major newspapers across the country. All this because he testified before a Senate panel Nov. 18 that the FDA, his employer for 20 years, is incapable of protecting the public from dangerous drugs once they come on the market.

"What I'm painting is a picture of an FDA that is completely insensitive to drug safety," Graham says.

On Saturday, no one seemed to recognize the wiry 50-year-old, clad in jeans, checked shirt and fleece vest, as he sipped his usual decaf mocha with skim milk and talked passionately about his new role as whistle-blower.

One customer did walk over to ask him to stop talking so loudly about bowel movements, part of his discussion of Lotronex, a drug for irritable bowel syndrome. It came back on the market after it was withdrawn because of safety concerns.

The study that has thrown Graham into the limelight involved analyzing a database of 1.4 million Kaiser Permanente members. Graham and his collaborators compared the rate of heart attacks and sudden cardiac deaths in patients who took Vioxx or Celebrex, its main competitor, or other non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen.

"We did this study because I recognized Vioxx was a potential disaster," Graham says. It had all the ingredients: a blockbuster drug used by millions that carried a significantly increased risk of heart attacks, the leading killer in industrialized countries. "I don't think that (FDA management) appreciated what we might find."

Graham and his collaborators found that Vioxx users had a higher rate of heart attacks and sudden cardiac deaths than Celebrex users.

Initially, the study received little publicity. Graham presented his results Aug. 25 at a scientific meeting in France. But five weeks later, on Sept. 30, Merck pulled Vioxx off the market because its own study had found a higher rate of heart attacks and strokes in patients taking the drug than in those on a placebo.

Suddenly, Graham's work and questions about what the FDA knew about Vioxx and when were making headlines. A whistle-blower was born. "FDA has made a systematic attempt to block me in the exercise of my free-speech rights," Graham says.

- Graham says his superiors pressured him to soften his conclusions before presenting them at the August meeting in France. In a news release the day before the Senate hearing, acting FDA commissioner Lester Crawford said Graham voluntarily revised his conclusions. "FDA encourages open and vigorous internal debate about the often difficult scientific questions it routinely faces," Crawford said.

Graham paints a different picture: "When you live in a climate of fear, retaliation and intimidation, no decision that one makes is entirely voluntary."

- E-mails between Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, and Richard Horton, editor of The Lancet, a medical journal that had accepted Graham's Vioxx study, suggest that the agency tried to plant doubts about the credibility of the results.

- Graham says friends at the FDA have told him that agency officials plan to force him into an administrative job. The agency, saying it could not discuss personnel matters, would neither confirm nor deny that Graham is to be transferred.

"I don't know what's at the bottom of this," Graham says. "The reaction of FDA management to my study of Vioxx is disproportionate to the study."

Sen. Chuck Grassley, R-Iowa, last week called for a government investigation into whether FDA management may have tried "to discredit an outspoken safety officer who was challenging the FDA's drug-safety policies." In a letter Monday, Grassley, chair of the Senate Finance Committee that heard Graham's testimony, asked Crawford whether he was planning to fire or transfer Graham against his wishes.

Graham says he has many supporters among the agency's rank and file as well as the public. Colleagues gathered in a cafeteria to watch a broadcast of his Senate testimony. When he returned to work the next day, they greeted him with hugs, kisses and pats on the back.

Graham says he has received hundreds of e-mails and telephone calls. Nearly all, he says, are variations on "thank you so much. You're in our prayers. We appreciate what you are doing. This must be so hard on your family."

Graham says he has heard concerns similar to his from counterparts who monitor medical devices and biologics, such as vaccines, but they're reluctant to come forward.

"They are absolutely afraid for their jobs," Graham says. "We've got families to support." He's married to his college sweetheart, and they have six children ages 9 to 23.

Graham could make a fortune as an expert witness, as other former FDA scientists have, says Wayne Ray, a preventive medicine professor at Vanderbilt University and co-author on Graham's Vioxx study.

But that won't happen, Ray says. "Dave is an excellent epidemiologist. He is extremely hardworking. He's extremely honest. He's extremely conscious of data and data accuracy. And he's very devoted to public health. Given those characteristics, I think the job he wants most is the job he has now."