House Subcommittee Requests Unpublished Data on Antidepressant Use in Children
The House Energy and Commerce Committee's Subcommittee on Oversight and Investigations on Wednesday asked Pfizer, Wyeth, Eli Lilly and GlaxoSmithKline to submit any unpublished data involving the use of antidepressants in children, Bloomberg/Philadelphia Inquirer reports (Dooley, Bloomberg/Philadelphia Inquirer, 2/5). Last month, the Washington Post reported that some pharmaceutical companies have declined to disclose or publish most clinical trials on the use of selective serotonin reuptake inhibitors to treat depression in children. Concerns about the use of SSRIs in children has increased since the British Medicines and Healthcare Products Regulatory Agency in a December letter to British physicians recommended against the use of six SSRIs in children because of a potential link to an increased risk of suicide. The FDA last October issued a public health advisory that asked U.S. physicians to use caution when they prescribe antidepressants to children and adolescents. The FDA committee has begun to review the results of 20 studies of eight antidepressants that involved more than 4,100 children because of concerns about the effects of the medications (Vedantam, Washington Post, 1/29). Pharmaceutical companies are not required to release data from unpublished studies. Some critics said that practice makes it possible for pharmaceutical firms to keep "unfavorable data secret," Reuters reports.
In a letter to the drug makers, subcommittee Chair Jim Greenwood (R-Pa.) wrote that the panel is requesting the information "in light of protecting the public health of children and/or the need to expedite public and physician confidence in the use of antidepressants" (Reuters, 2/4). Greenwood wrote that the U.S. psychiatric establishment has "repeatedly assured" the public about the safety of antidepressants, but he added that "some psychiatrists and advocates are concerned that mainstream psychiatry is biased by widespread financial ties to the pharmaceutical industry" (Bloomberg/Philadelphia Inquirer, 2/5). A GSK spokesperson said that the company "expects to fully cooperate" with the request, and a Wyeth spokesperson said that the company is evaluating the letter. Spokespeople for Lilly and Pfizer did not respond to requests for comment, Reuters reports (Reuters, 2/4).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.