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 In response to growing concerns about the drug, Paxil’s maker, GlaxoSmithKline, released unpublished data.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… Read full this story
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