The FDA whistleblower who turned a public light on the dangers of pain medication Vioxx, told an Ann Arbor audience on Friday that the government needs to restructure the agency or more Americans will die.
Dr. David Graham is a scientist at the U.S. Food and Drug Administration. His job is to evaluate the safety of drugs after the FDA has approved them. Last year, he testified before the Senate that an FDA failure to act on research resulted in 140,000 Vioxx patients suffering heart attacks and 60,000 of them dying.
That death count “is the equivalent of the Vietnam War,” he told an audience of about 250 doctors, academics and the public at the University of Michigan Hospital.
The comments resonated in Ann Arbor, home to one of Pfizer Inc.’s drug research and development hubs. Pfizer pulled Bextra, a painkiller in the same class as Vioxx, from the market in April after the FDA asked for its recall, citing inadequate information about the risks associated with its long-term use.
Vioxx is made by Merck & Co. Inc. The Vioxx deaths, Graham said, occurred because of the failure of the FDA to protect the public.
The FDA declined to respond directly to Graham’s comments. But an FDA spokeswoman said the agency undertook a drug safety initiative in November to improve the way it evaluates drugs after they go public.
But Graham said it’s not enough and that catastrophic drug events will happen again without a major structural change in the agency assigned the task of making sure prescription drugs are safe and effective before they are made available to the public.
“Vioxx was the single greatest drug safety catastrophe in the history of the U.S.,” Graham said. “There are other catastrophes out there, they just haven’t been as monumental.”
And absent structural change, he said, there will be more.
Graham argues that the FDA needs two separate arms—one to evaluate the benefits of using a drug and how safe it is before it is made available to the public and another to independently evaluate drug safety once it’s out there.
He also said that the FDA’s focus is tied too closely to serving the pharmaceutical industry instead of serving the public.
“Right now 80 percent of FDA resources are focused on reviewing and approving new drugs for the market,” Graham said. At least 50 percent should be focused on making sure they’re safe once they’re out there, he said.
Mark Horn, medical director of the government relations group at Pfizer, said he is not convinced that there is a benefit to creating an adversarial relationship within the agency or between the agency and the pharmaceutical industry.
“Collaboration between the industry and the agency is a good thing,” Horn said. “It increases our productivity; it increases our efficiency.”
But Graham said there need to be independent checks and balances to ensure Americans get safe medicines.
Some of the FDA officials who approved the drug for public consumption in the first place are also responsible for regulating the drug’s safety after it goes on the market, he said.
It doesn’t work, Graham said, because those scientists have invested so much time and research in the approval process. By the time the drug gets on the market, they feel a parent-like ownership of the drug. Then, he said, they refuse to act or delay acting on information that indicates safety problems with drugs.
Between June 2000 and April 2002, while the FDA was negotiating with Merck about what the Vioxx label would say, Graham said, 16,000 people taking the drug suffered heart attacks. The drug was taken off the market last September.
“There’s a cost to delay and it’s measured in human lives,” Graham said.