FDA Whistleblower says Agency Smeared Him over his Vioxx Views

posted on:
May 31, 2006

author:
Staff

 A U.S. Food and Drug administration whistleblower who claimed Merck & Co.’s Vioxx painkiller caused 140,000 heart attacks and strokes testified that co-workers at his agency tried to damage his reputation. 

I experienced threats, intimidation and actually what, in my view, appears to have been a very organized and orchestrated campaign to smear and discredit me,” Dr. David Graham said in a May 9 videotaped testimony taken for Vioxx litigation. FDA officials worked "hand in glove” with Merck to tarnish him, Graham said according to a sealed transcript of his remarks obtained by Bloomberg News.

Graham came to prominence in November 2004 when he told a U.S. Senate panel that Vioxx was "the single greatest drug safety catastrophe” in U.S. history and that the FDA was “incapable of protecting America against another Vioxx.” Merck had withdrawn the drug weeks earlier, after a study showed Vioxx doubled the risk of heart attacks after 18 months of use.

Merck, the fourth-largest U.S. drugmaker, faces 12,000 Vioxx lawsuits. Vioxx users and their families already have won $298 million in total damages at three trials, an amount that will be cut to $48 million under state damage limits.

Graham’s testimony may be used by future Vioxx users to challenge Merck’s claim that the FDA’s 1999 approval of the drug shows that it was safe and adequately tested.

Defense Funds

Merck, based in Whitehouse Station, New Jersey, has set aside $970 million to defend the Vioxx lawsuits and nothing to cover liability. The company has vowed to fight every case. Merck has won three other cases at trial.

"Dr. Graham’s comments do not represent a fair assessment of the science or his own agency,” said Ted Mayer, a Merck attorney at Hughes Hubbard & Reed in New York. "Unlike Dr. Graham, we have the utmost respect for the agency, its dedicated scientists, and its procedures.”

U.S. District Judge Eldon Fallon in New Orleans, who is overseeing 5,200 federal Vioxx suits, ordered Graham’s deposition over FDA objections, saying it was “vitally important” to "know the truth surrounding Vioxx” and the agency’s role.

Graham, an epidemiologist and 22-year FDA veteran, said that agency employees who try to block a drug’s approval or limit its marketability are "severely reprimanded, pressured, criticized and threatened.”

Merck attorney Phil Beck sought to undermine Graham’s credibility during the deposition. Beck asked about FDA e-mails accusing Graham of using "bad science” in both his Senate testimony and in a 2005 article in the Lancet, a medical journal. In the Lancet article, Graham estimated that Vioxx caused 88,000 to 140,000 cases of serious coronary heart disease.

Vioxx Withdrawal

Beck asked Graham about telling the journal’s editor that the FDA had warned Merck about the article. Beck also asked Graham about saying his analysis was what prompted Merck to pull the drug. Merck says it withdrew Vioxx because of a study showing the increased risk after 18 months.

"That was kind of a wild and crazy charge you made to the editor of Lancet, don’t you agree?” Beck asked Graham, who has worked on 10 drugs that were withdrawn.

"No, it’s not wild and crazy,” Graham said. "If you experienced what I experienced, you would understand.”

The next Vioxx trial begins June 5 in Atlantic City, New Jersey. Elaine Doherty, 68, will try to convince jurors that the drug caused her heart attack. Doherty’s attorney, Michael Galpern, wouldn’t comment on the deposition. About 6,400 Vioxx lawsuits are awaiting trial in Atlantic City.

Graham, associate director of medicine and safety in the FDA’s Office of Drug Safety, reached his conclusions about Vioxx after examining its safety with Vanderbilt University researcher Wayne Ray.

The Vigor Study

They studied records of 1.4 million patients insured by Kaiser Permanente and looked at a 2000 study, known as Vigor. It found Vioxx caused five times more heart attacks than the painkiller naproxen. They also compared Vioxx with other painkillers, including Pfizer Inc.’s Celebrex.

By August 2004, Graham had concluded that Vioxx caused 27,000 heart attacks and strokes and was a risk at doses of more than 25 milligrams. Some FDA colleagues faulted Graham in e- mails, noting that he found only 10 heart attacks among users of high-dose Vioxx.

"This is misleading at best and deceptive at worst,” Dr. John Jenkins wrote in an e-mail discussed during the videotaped testimony. "These types of overstated conclusions are typical of David’s writing.”

Another colleague, Sharon Hertz, wrote that Graham’s findings were "simply bad science,” according to the testimony. Dr. Anne Trontell said Graham “overstepped the bounds” of what he could say about Vioxx, his testimony showed.

Graham declined to comment.

Conference in France

Even after the criticism, Graham testified that the FDA still approved his request to present the data at a conference in France. After the meeting, Graham and Ray reclassified high-dose and low-dose Vioxx users, recalculated the number of heart attacks based on rates found in clinical trials and made new assumptions about the drug’s 20 million users. The changes led Graham make a higher estimate for the number of heart attacks.

"The record shows that others in the agency felt that in his article there was evidence of data manipulation, and he makes speculative projections that have no sound basis in science,” Mayer said. "It’s not surprising that he drew criticism with regard to those matters.”

He presented the new numbers to the Senate Finance Committee on Nov. 18, 2004, and included them in the article submitted to the Lancet, prompting Dr. Steven Galson at Merck to contact the journal’s editor, Richard Horton. Merck’s intervention delayed publication of the Lancet article, Graham testified.

A Promotion

Graham said former FDA Commissioner Lester Crawford had offered him a promotion nine days before his Senate testimony. Graham said he declined and was surprised by the timing.

"The commissioner is offering me this really high-level job with a lot of responsibility, and then one week later, he’s calling me all sorts of names in an FDA public statement that’s issued on the eve of my Senate testimony,” Graham said.

Notes of a meeting between a Merck scientist and an FDA official before the Senate testimony refer to "an opportunity to get message out on Graham,” according to Graham’s testimony.

Thomas Kline, who represents Vioxx users, said the FDA “was suggesting to Merck that we provide journalists with a copy of our critique on Graham,” according to the testimony.

"Quite shocked” was how Graham described his reaction to the notes. The evidence "demonstrates more clearly just how widespread the organized campaign to discredit and smear me was, that I’m not crazy and psychotic.”

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