Merck Drug Scandal
It's not as if people in power didn't know about the impending disaster — what David Graham, a Food and Drug Administration (FDA) drug safety official, calls “maybe the single greatest drug-safety catastrophe in the history of this country.''
Testifying before a Senate committee in November, Dr. Graham put the number in United States who had suffered heart attacks or stroke as result of taking the arthritis drug Vioxx in the range of 88,000 to 139,000.
As many as 40 percent of these people, or about 35,000-55,000, died as a result, Graham said.
The unacceptable cardiovascular risks of Vioxx were evident as early as 2000 — a full four years before the drug was finally withdrawn from the market by its manufacturer, Merck, according to a study released by The Lancet, the British medical journal.
“This discovery points to astonishing failures in Merck's internal systems of post-marketing surveillance, as well as to lethal weaknesses in the U.S. Food and Drug Administration's regulatory oversight,” The Lancet editors wrote.
Authors of the Lancet study pooled data from 25,273 patients who participated in 18 clinical trials conducted before 2001. They found that patients given Vioxx had 2.3 times the risk of heart attacks as those given placebos or other pain medications.
Merck withdrew Vioxx on September 30, 2004, after a company-sponsored trial found a doubling of the risks for heart attack or stroke among those who took the medicine for 18 months or more.
Merck says it disclosed all relevant evidence on Vioxx safety as soon as it acquired it, and pulled the drug as soon as it saw conclusive evidence of the drug's dangers.
“Over the past six years,” Merck CEO Raymond Gilmartin told the Senate Finance Committee at the November hearing where Graham made his big splash, “since the time Merck submitted a New Drug Application for Vioxx to the FDA, we have promptly disclosed the results of numerous Merck-sponsored studies to the FDA, physicians, the scientific community and the media and participated in a balanced, scientific discussion of its risks and benefits.”
Until the September clinical trial results came in, Gilmartin said, “the combined data from randomized controlled clinical trials showed no difference in confirmed cardiovascular event rates between Vioxx and placebo and Vioxx and NSAIDs other than naproxen. When data from the APPROVe study [the September results] became available, Merck acted quickly to withdraw the medicine from the market.”
But there is evidence that strongly suggests a different version of the story.
The Lancet findings came in the wake of new disclosures that suggest Merck was fully aware of Vioxx's potential risks by 2000.
The Wall Street Journal revealed e-mails that confirm Merck executives' knowledge of their drug's adverse cardiovascular profile — the risk was “clearly there,” according to one senior researcher.
Merck's marketing literature included a document intended for its sales representatives which discussed how to respond to questions about Vioxx — it was labeled “Dodge Ball Vioxx.”
“Given this disturbing contradiction — Merck's own understanding of Vioxx's true risk profile and its attempt to gloss over these risks in their public statements at the time — it is hard to see how Merck's chief executive officer, Raymond Gilmartin, can retain the confidence of the public, his company's most important constituency,” the Lancet editors wrote. “The FDA's position is no less [un]comfortable. The public expects national drug regulators to complete research in their ongoing efforts to protect patients from undue harm. But, too often, the FDA saw and continues to see the pharmaceutical industry as its customer — a vital source of funding for its activities — and not as a sector of society in need of strong regulation.”
Dr. Graham, the federal drug-safety reviewer, continues to seek to publish his study demonstrating the dangers of Vioxx, but he has been delayed and demeaned by top officials at the Food and Drug Administration.
At the Senate hearing, Dr. Graham said that the FDA “as currently configured is incapable of protecting America against another Vioxx,” because of ties between agency reviewers and the pharmaceutical industry.
Graham says that as a result of his testimony, his bosses have threatened to toss him out of the FDA's drug safety unit.
In December 2004, a group of 22 members of the U.S. House of Representatives sent a letter to the FDA complaining about efforts to intimidate and smear Dr. Graham.
House members, led by Bart Stupak, D-Michigan, sent the letter to acting FDA Commissioner Lester Crawford “to express strong dismay at recent reports about efforts taken by some at FDA to discredit and smear Dr. Graham.”
“This shameful behavior by management cannot continue, and we demand you put a stop to it,” the letter said.
“Your treatment of Dr. Graham undoubtedly has had a chilling effect on the willingness of FDA employees to speak up and disagree when they believe the public's health is at risk,” the letter said.
If Graham were targeting just Merck, his job might be safe. But it is about more than Vioxx and Merck.
At the Senate hearing, Graham said that at least five medications currently on the market pose such risks that their sale ought to be limited or stopped. Graham named the five as Meridia, Crestor, Accutane, Bextra and Serevent.
In November 2004, Forbes.com — capitalist tool that it claims to be — named David Graham “face of the year.”
We join with Forbes in saluting Graham “for his steadfast advocacy of drug safety and his willingness to blow the whistle on his bosses.”
“Without Graham, the Vioxx debacle might have been seen as an isolated event,” Forbes wrote. “But because he was willing to step into the spotlight, the withdrawal of Vioxx from the market looks like part of a systemic failure to properly weigh the risks and benefits of drugs. To hear Graham tell it, this is part of a systemic failure to address drug safety on the part of the FDA, a story that reaches back over the entirety of his 20-year career at the agency. That could kick-start a broad debate over what risks we're willing to take every time we swallow pills. In the long run, change would be good for regulators and drug companies.”
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