WASHINGTON, D.C.--Several prominent members of Congress plan to introduce legislation that would create a clinical trials registry, in which all trials must be listed from inception and results posted as they emerge.
The idea of clinical trials registries has been bandied about for years. But it was brought to the fore last year, when the U.S. Food and Drug Administration's (FDA's) review of data on an antidepressant, Paxil, found that children taking it had higher-than-expected rates of self-harm. In response to growing concerns about the drug, Paxil's maker, GlaxoSmithKline, released unpublished data. They showed that Paxil was ineffective in treating depression in youngsters. FDA later admitted that only three of the 15 pediatric antidepressant trials submitted to it by various companies had found that the medication worked.
At a hearing yesterday, members of Congress spent nearly 2 hours grilling FDA official Janet Woodcock, who helps oversee drug approvals. She suggested that FDA's hands were tied when it came to releasing negative data about a company's trials. (Although companies must submit all relevant data to FDA, they're not required to release data publicly.) "This is a conundrum for the agency," said Woodcock, in response to a question about whether FDA has a responsibility to the medical community to release negative results.
One solution, some in Congress say, is a mandatory registry, in which all clinical trials must be registered at their inception. Representatives Henry Waxman (D-CA) and Edward Markey (D-MA) are planning to introduce legislation in the coming weeks for such a registry, and a companion bill in the Senate is also being written. Meanwhile, on 8 September, an international consortium of 13 medical journals announced that it would require trials to be registered before the journals would consider them for publication.
Pharmaceutical companies, however, are pressing for voluntary registration. Representatives from several, including GlaxoSmithKline and Eli Lilly, announced at yesterday's hearing that they will disclose the results of all trials they conduct. On 7 September, the Pharmaceutical Research and Manufacturers of America (PhRMA), an industry trade group, announced that it was launching a voluntary registry in October.
Some observers are dubious. "If it works, I'll be staggered," says Drummond Rennie, a physician and health policy expert at the University of California, San Francisco, and deputy editor of the Journal of the American Medical Association, of the drug-company registries. Rennie supports the kind of legislation Waxman and Markey plan to put forth. "You can't hide stuff like this from people in peril of dying," he says.