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In the wake of the Vioxx and Bextra recalls, a coalition of health and consumer groups is calling for reform in the process used by the FDA to test and approve new drugs. These groups include the Center for Science in the Public Interest, the National Women's Health Network, the Center for Medical Consumers, the U.S. Cochrane Center Consumer Coalition, and several other health-advocacy groups. They charge that the FDA has become too reliant on scientists connected with industry that it routinely grants waivers for conflicts of interest. The groups are also calling for greater transparency and for greater opportunities for public participation in the federal advisory committee process.
In light of the Vioxx fiasco, FDA drug chief Dr. Steven Galson told a congressional hearing in May 2005 that the agency is taking steps to improve awareness by the public and doctors of potential drug risks as soon as they arise. He said that what was happening with Vioxx wasn't clear-cut until the research was completed the previous summer. He also acknowledged that it may have taken too long to put a new warning label on the drug.
Critics, and now some lawmakers contend that the FDA failed to police Merck's efforts to downplay Vioxx's cardiovascular risks, including a card of misleading safety information that salespeople distributed to doctors. Although a link between Vioxx and heart attacks first emerged in a medical journal in 2000, Merck managed to build the drug into a $2.5 billion-a-year product by 2003. Representative Henry Waxman, a Democrat from California, said. "Merck gave its sales force a specific script to use with doctors when showing them the card, telling them to say to doctors that the cardiovascular mortality of Vioxx was eight times lower than other drugs."
Critic Dr. David Graham has argued 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 a recent conference. "At least 50 percent should be focused on making sure they're safe once they're out there", he said.
The House Committee on Government Reformheld a hearing in Washington on May 5, 2005 on what Merck, the third-largest U.S. drugmaker, and the U.S. Food and Drug Administration should have done to protect the public from the dangers of Vioxx. The committee said its staff examined more than 20,000 pages of Vioxx-related documents before the meeting. Representative Gil Gutknecht, a Minnesota Republican, told the committee "It (the FDA) seems to be that they are shirking their responsibility to consumers and physicians."
Because of failure of the FDA's drug approval policy, combined with the lack of any FDA resources to monitor drugs once they reach the marketplace, "We are faced with what may be the single greatest drug-safety catastrophe in the history of this country or the history of the world... a catastrophe that I strongly believe could have (and) should have been avoided," according to the testimony of scientist David Graham before the Senate Finance Committee. Graham is the director for Science and Medicine at the FDA's Office of Drug Safety.
In a letter to the FDA dated March 10, 2005, a group of health and consumer advocates said the agency failed to comply with the Federal Advisory Committee Act (FACA) when it assigned scientists with ties to manufacturers of arthritis pain drugs known as Cox-2 inhibitors, including Vioxx and Celebrex, to serve on a panel charged with evaluating those drugs. Last month, Center for Science in Public Interests (CSPI) found that of 32 experts serving on the FDA's Arthritis Drug and Drug Safety Advisory Committee, ten had received funding from Pfizer, Merck, or Novartis.
|Sheri Ann Richerson|