The world's four main pharmaceutical trade groups announced yesterday that they will publish far more data about clinical drug trials than now required by law.
The Pharmaceutical Research and Manufacturers Association, along with industry groups in Europe, Japan and some developing nations, said they will begin posting expanded information about new and ongoing trials by summer.
American companies are required by law to provide information on clinical trials dealing with life-threatening diseases, but the groups said yesterday they are now committed to going beyond that requirement and will provide information about trials for all diseases.
"Patients and physicians have asked pharmaceutical companies to make available information about all clinical trials, not just some trials, and make that information more accessible," PhRMA President Billy Tauzin said. "We're doing this because our industry recognizes that sometimes what the law requires doesn't give patients all they need."
After heavy criticism from medical and consumer groups for withholding information about trials with negative findings about their products, drug companies have been under considerable pressure to change their ways. The American Medical Association, as well as editors from top medical journals, has called for mandatory publishing of all clinical trials.
The new industry commitment to publish more clinical trial data will not be binding, however, and critics said that makes it insufficient. Reps. Henry A. Waxman (D-Calif.) and Edward J. Markey (D-Mass.) said earlier that they would introduce legislation requiring public disclosure of all later-stage clinical trial information.
"A voluntary proposal from the drug industry that is unenforceable and full of loopholes doesn't really move us forward," Waxman said. "We already know many companies ignore the current law."
Under the industry plan, information about new clinical trials will be posted on the government Web site, www.clinicaltrials.gov, beginning July 1. Trials of ongoing medicines will be posted by Sept. 13.
