FDA: Most Drug Makers Skip Study Listings

The drug industry is largely ignoring a federal law requiring that thousands of medical studies be listed on a government database, federal research suggests. The Internet-based database, ClinicalTrials.gov, opened in 2000. It's not meant to be a comprehensive list, but any study of a treatment's effectiveness against a serious disease is supposed to be listed. The requirements were further spelled out for industry in 2002 Food and Drug Administration (news - web sites) guidelines. An FDA (news - web sites) check against its own internal research lists shows that in 2002, just 48 percent of industry-funded studies for cancer therapies alone were reported to the public database. In contrast, more than 90 percent of National Cancer Institute (news - web sites)-funded studies were listed, said FDA Associate Commissioner Theresa Toigo. The FDA hopes to finish its evaluation of 2002 study listings by year's end, but Toigo said there are no signs that treatments for other diseases fared better — or that compliance has improved much since. FDA officials say the law includes no penalties for database violations, so it's unclear what can be done to spur compliance. While this database lists only the existence of certain studies, doctor groups are debating whether some more comprehensive registry might ensure that all results of such studies eventually are made public. Doctors recently learned that drug makers never published many studies where childhood antidepressant use failed, publicizing only positive results. Some 5,754 ongoing studies — just 13 percent of them industry-funded — were listed on ClinicalTrials.gov Tuesday. Drug companies conduct the vast majority of the nation's treatment studies.

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