Members of the House Energy and Commerce Committee blasted the Food and Drug Administration (FDA) last week for urging drug companies to withhold information on the efficacy of antidepressants used on children. The controversy comes just as patient advocacy groups, the American Medical Association, and a dozen medical journal editors are calling on pharmaceutical companies to register their clinical trials in order to meet increasing public demand for information on the effectiveness and safety of drugs. Lack of Information on Clinical Trials Leads to Use of Ineffective Drugs After British scientists determined in February that many antidepressants were not only ineffective but perhaps even unsafe for children, the FDA and the House Subcommittee on Oversight and Investigations began to review the clinical trials withheld from the public. The FDA also conducted its own studies on the safety and efficacy of antidepressants used on children. Two internal FDA studies confirmed that antidepressants do pose an increased risk of suicidal ideation for children. Furthermore, two thirds of clinical trials on antidepressants used on children found that the antidepressant medication performed no better than placebos. According to testimony from drug companies during a House Energy and Commerce Committee hearing on Sept. 9, FDA encouraged drug companies to withhold clinical trials information from the public. Drug company executives testified that FDA regulators said that releasing the information could scare parents and physicians away from the drugs. According to the Washington Post, "Janet Woodcock, FDA's deputy commissioner for operations, responded that regulators believe the jury is still out on the drugs. The negative trials, she said, did not mean the medications were ineffective." Because the FDA allowed and even urged the drug companies to withhold the clinical trial data, physicians and the public were denied critical information on the efficacy of such drugs. On September 15, FDA's Psychopharmacologic Drugs Advisory Committee and Pediatric Advisory Subcommittee recommended in a vote of 25-1 that antidepressants for children include a "black box" label warning of the increased risk of suicidal ideation associated with the drug. The black box warning is the highest level of label warning that the FDA issues. In a public statement, FDA supported the assessment of the committee. Journal Editors Demand Registration of Clinical Trials As reported by OMB Watch in July, FDA is actually required to keep a databank of information on clinical trials by the FDA Modernization Act of 1997, but the agency does not enforce it. The FDA had previously argued that it has not enforced the law because though the statute gives them the authority to establish the database, it does not give the agency explicit authorization to enforce reporting requirements. One indication of the incompleteness of the database is that a mere 16 percent of the registered trials were reported by the pharmaceutical industry, even though more than 80 percent of trials are funded by for-profit companies. Because the act is not enforced, drugs companies can pick and choose which studies they will make publicly available. Gregory D. Curfman, Executive Editor of the New England Journal of Medicine, told the Washington Post, "When a pharmaceutical company sponsors a clinical trial and the results turn out not to be in the best financial interests of the company, it has been our experience these results are not made public." The editors of 12 medical journals have responded by requiring drug companies to register their trials -- before the results of the study are known -- in order for the resulting studies to be eligible for publication. The editors hope to compel the pharmaceutical industry to release more information, particularly when studies yield results unfavorable to the industry. Although pharmaceutical companies could still withhold results, knowledge of the undisclosed clinical trials would still reveal critical information to the public. The House Energy and Commerce Committee will conduct another hearing Sept. 23 on "FDA's Role in Protecting Public Health: Examining FDA's Review of Safety & Efficacy Concerns in Anti-Depressant Use by Children."