Wall Street Journal Examines Controversy at FDA Over Report on Antidepressant Use in Children
The Wall Street Journal on Tuesday looked at the ongoing debate over why FDA medical officer Dr. Andrew Mosholder was not allowed to testify at a February public hearing about a report he compiled that found antidepressants may lead to suicidal behavior in children (Wilde Mathews, Wall Street Journal, 5/25). Last month, FDA officials acknowledged that agency managers did not allow Mosholder to testify at the hearing because they considered the results of his analysis preliminary. House and Senate Republican leaders at the end of March launched investigations into whether FDA managers prevented the release of the report. According to unnamed FDA sources, Mosholder planned to present a preliminary report that found selective serotonin reuptake inhibitors may increase the risk of suicide in children. A senior FDA official said that Mosholder did not present the report because the results were not finalized. The 33-page report, based on an analysis of 22 studies that involved 4,250 children and seven antidepressants, found that children who took the medications were twice as likely as those who took placebos to become suicidal. The report found that Effexor and Paxil almost tripled the risk of suicidal behavior, that Zoloft more than doubled the risk and that Prozac increased the risk the least. However, FDA officials raised some concerns about how Mosholder classified suicidal behavior in the report. FDA has commissioned researchers at Columbia University to perform a new study of the data to determine which behaviors the agency should consider suicidal (California Healthline, 4/16).
According to the Journal, critics have accused FDA of "a cover-up to protect a lucrative market for drug makers." However, the Journal reports that the events of the case "suggest a more complex situation, in which the agency took the initiative in uncovering much of the data but hesitated to make a declaration that was sure to alarm many patients and doctors." The situation "illustrates the FDA's challenge in balancing the need for prompt warnings about potential side effects from drugs against the risk of discouraging the use of helpful medicine," the Journal reports. The results of the Columbia study are due in June, and later in the summer the FDA advisory committee on antidepressants will meet to examine the updated information (Wall Street Journal, 5/25).
The different approaches that the United States and Britain have taken to the issue of antidepressant use in children leading to suicidal behavior illustrate the degree to which the health care cultures in the countries differ, Dr. Sally Satel, a psychiatrist and resident scholar at the American Enterprise Institute, writes in a New York Times commentary. After examining the clinical data, British regulators "strongly urged doctors not to use certain antidepressants ... for childhood depression because the risk of self-harm and suicidal thoughts was judged to be too great," Satel writes. However, officials in the United States, after examining the same data, decided that there was not enough evidence to "make up their minds on the safety issue, and doctors here continue to prescribe antidepressants to children in volume," Satel continues. She attributes the different reactions to a number of factors, among them "Americans' greater faith in medication, resulting from an enthusiasm about technological progress"; a tendency in the United States to "sell diagnoses"; fewer choices in medication in Britain; a "more modest sense of entitlement" among British patients; and the relative ease with Americans can obtain prescription drugs. "All of these factors help explain why British health regulators have a lower tolerance for risk," Satel writes, concluding, "Lacking a strong cultural investment in antidepressants, [the British] have already decided that any risk of self-harm is too high" (Satel, New York Times, 5/25).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.