Mandatory clinical trial registration negative for Drug Makers (and their typical spin- oh, the side-effects???)
New bill targets drug data disclosure- Drug makers criticized for only publicizing favorable study results
By Laura Gilcrest, CBS MarketWatch
Last Update: 3:39 PM ET Sept. 8, 2004
WASHINGTON (CBS.MW) - Drug makers are increasingly under fire from patient and physicians group for hiding negative information about a new drug; data that the groups say is vital health data that should be publicly available. Responding to the criticism, lawmakers may unveil legislation on Capitol Hill this week to force drug companies to register their clinical trials before the studies begin, then submit the results to a public database. The bill, co-sponsored by Edward Markey (D-Mass.) and Henry Waxman (D-Calif.), may be introduced as part of a Congressional hearing Thursday that focuses on disclosure of data from pediatric studies of anti-depressant drugs, a Markey aide told CBS MarketWatch.
The House Energy and Commerce Committee's Oversight and Investigations Subcommittee, which is holding the hearing, is training its spotlight first on studies of anti-depressants in children, due to a troubling rise in suicide rates among young patients taking these drugs.
Under the bill, firms would have to register their studies of new therapies as a condition of (Institutional Review Board) approval, the aide said. (IRBs are the independent bodies that monitor clinical studies and report any problems to the U.S. Food and Drug Administration.)
The Markey aide said that the study results would go into the existing database at the National Library of Medicine, which is run by the National Institutes of Health. The database was designed for patients to find studies of drugs for serious or life-threatening diseases, she said, but the expanded database would allow physicians to learn more about new drugs so they can make better treatment decisions. The bill may exempt early trial phases, such as Phase One safety testing, but the details are still being worked out, she said.
"We want (clinical trial registration) to be mandatory to make sure drug companies aren't hiding anything," she said.
Under current rules, drug makers are able to withhold to the public unfavorable studies of drugs in the regulatory pipeline - such as a study showing that the drug doesn't work against a particular disease. For example, a drug maker can publicize results of a pediatric clinical trial showing that its drug is effective in treating depression in pediatric patients, but can hold back studies showing the new therapy didn't work in treating anxiety disorder.
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