FDA creates new drug safety board

By Shaoni Bhattacharya The US drugs regulator, the Food and Drugs Administration, is creating a new drug safety board to monitor drugs already on the market in the wake of the storm over the deadly risks associated with the drug Vioxx. The drugs body, which has come under fire in recent months for failing to inform the US public of potential risks of newly licensed drugs, announced the creation of its Drug Safety Oversight Board on Tuesday. “FDA understands that the public expects better and more prompt information about the medicines they take every day,” says acting commissioner Lester Crawford. “Our goal is to prepare the agency for these new demands by improving the way we monitor and respond to possible adverse health consequences that may arise regarding drugs that have been approved for sale to US consumers.” The new board will aim to make the agency’s “review and decision-making processes more independent and transparent”, it says. But the announcement has met with scepticism from consumer groups and ethicists who question the FDA’s closeness to the pharmaceutical industry and whether the independent board – to be staffed by members of the FDA and other government agencies – will have any real clout. Currently, the FDA’s Office of Drug Safety monitors drugs after they are licensed – learning about adverse events from drugs manufacturers and voluntary reports submitted by patients and doctors via its Medwatch programme. But it has been criticised for lacking independence and resources. The new drug safety board will share drug information more quickly and to a broader audience, the FDA promises. But experts are dubious. “It’s really a cosmetic way of dealing with a much more serious problem,” says Sidney Wolfe, director of the non-profit Public Citizen Health Research Group in Washington, DC, US. “In the absence of any fundamental change, it’s a cruel hoax.” He has called for the FDA to pull two other drugs in the same class as Vioxx from the market – Celebrex (celecoxib) and Bextra (valdecoxib). Others question the composition of the new board. “I’m a little surprised that the description of the board doesn’t include outside advisory committees empowered to ask the hardest questions,” Thomas Murray, president of the Hastings Center, a medical think tank in Garrison, New York, US, told Newsday. But representatives of the pharmaceutical industry have welcomed the move. A spokesman for the Pharmaceutical Research and Manufacturers of America says the group will support the FDA’s efforts. “The American Association of Pharmaceutical Scientists applauds the FDA for its proactive decision on this issue,” says Jerome Skelly, president of the non-profit organisation, made up of individual pharmaceutical scientists. “Discussing drug risks and benefits in such an environment is essential to maintaining public safety and protection.” The FDA came under fire when it emerged that data linking the anti-inflammatory drug Vioxx (rofecoxib) to an increased risk of heart attack and stroke had existed for years. The drug’s manufacturer – Merck & Co., Inc – voluntarily withdrew Vioxx in September 2004. The drugs agency was also accused by one of its own researchers, David Graham, of hindering him in publishing his negative findings on the controversial drug. New findings published on Wednesday further support the link between Vioxx and cardiovascular disease. The drug nearly doubled cardiovascular events when compared with placebo in the study of over 2500 people. Jeffrey Drazen, who writes an editorial alongside the research paper in New England Journal of Medicine,
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