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Voluntary drug trial registry won’t ensure prescription drug safety

Thursday, Jan. 6, 2005
Susan Herold, 202-462-6262

Drug Industry’s Plan to Voluntarily Report Clinical Trials
Falls Short of Ensuring Drug Safety for Consumers

(Washington, D.C.) – A global pharmaceutical industry plan announced today to “voluntarily disclose” information about clinical drug trials falls far short of ensuring the safety of prescription drugs on the market, as drug companies still will not be legally required to make public the potentially negative results of their studies or the possible harmful side effects.
“Trusting drug companies to publicize negative information is a bitter pill for consumers to swallow,” said Rob Schneider, director of Consumers Union’s Prescription for Change campaign, an effort to improve prescription drug safety and pricing.
“If drug companies do not have a legal requirement to place important details of their drug studies in a public registry and disclose the results, we continue to run the risk of having unsafe drugs on the market that doctors and consumers aren’t aware of,” Schneider said.
Consumers Union continues to support federal legislation that would require drug manufacturers to publicly register all clinical drug trial and make the trial results public. In the past year, information has surfaced that the makers of Paxil and Vioxx may have known about negative clinical trial results about their products, but did not make the information public. Paxil now carries the strongest safety warnings, and Vioxx was removed from the market.
The Pharmaceutical Research and Manufacturers of America said beginning July 1, its member companies will voluntarily post information on all new clinical trials to a government Website. All ongoing trials are to be posted by Sept. 13. Under current law, drug companies are only required to register clinical trials that deal with serious or life-threatening diseases or conditions, but are not required to provide the trial results.
According to published reports of the industry trade group’s plan, not only is the proposal voluntary, it also does not cover posting of Phase I studies – the first step in the drug approval process. It also calls for results to be published within one year of a new drug’s approval, or within one year of a new trial being completed.
“Trial results and data should be immediately posted, so consumers and physicians have the most current information,” said Janell Mayo Duncan, regulatory counsel for Consumers Union. “And we want to ensure that all studies of drugs now on the market are available. That is why it is so important that we have a law requiring all this vital drug safety information be made public.”
For more information on a clinical trial registry law, go to Consumers Union