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FDA panel told public drug trials needed to avoid Vioxx problems

Wednesday, Feb. 16, 2004
Contact: Susan Herold, 202-462-6262

FDA Panel Told Mandatory Public Drug Trials Would Help Bring Safety Concerns to Light Faster

(Washington, D.C.) – At today’s Food and Drug Administration hearings on the safety of arthritis pain drugs, Consumers Union renewed its call for the agency to address systemic problems that have delayed and stifled availability of drug safety information to the public. It also urged the FDA to push for laws to make drug studies public.
“To a great extent, the public has lost confidence in the ability and the willingness of FDA to protect consumers from unreasonably dangerous drugs,” Consumers Union said in statement to the FDA advisory panel.
“Had clinical trial data regarding NSAIDS (arthritis pain medication) been more widely available, it is likely this joint meeting to consider the safety of these drugs would have occurred several years ago, saving lives and better protecting public health.”
Click here to read our comments. The key points submitted by Consumers Union to the panel call for: 1) a strong and independent Office of Drug Safety 2) passage of law requiring all drug companies register and make public the results of all their clinical drug trials and 3) increased funding to compare the effectiveness and safety of drugs in the same class.
Consumers Union’s free public education project on the safety, effectiveness and price of prescription drugs, Consumer Reports Best Buy Drugs, has a free report on these arthritis pain drugs at its Web site, www.CRBestBuyDrugs.org. The report identifies Best Buys in this category – based on independent analysis of safety, effectiveness and price – and gives in-depth information on the options available for treating arthritis pain.