Another Study Contradicts FDA Advisory Concerning Newer Antidepressants
Yet another large scale study has contradicted the March 2004 FDA public health advisory warning that newer antidepressants are associated with worsening depression and suicidality. This new study of over 65,000 patients who were enrolled in the Group Health Cooperative and receiving antidepressants found no increased risk of suicide associated with prescription of newer antidepressants, including, notably, the selective serotonin reuptake inhibitors (SSRIs) [Link]. Results of this study are consistent with results of a recent of study of 146, 095 patients receiving antidepressants in primary care in the United Kingdom [Link], as well as two meta-analyses of the results of clinical trials data.James Coyne is Professor of Psychology and Co-director of the Health Research and Behavioral Sciences Program of the Abramson Cancer Research Institute of University of Pennsylvania
Even at the time of its warning, the FDA conceded that available evidence did not indicate any increased risk of suicide associated with these drugs. [Link]. At the hearings leading to the FDA public health advisory, first personal accounts from the family members of victims of suicide and vocal representatives of groups who had never encountered a psychotropic medication they liked were favored over research data. The FDA's handling of the issue of risks associated with antidepressants gives a new dimension to concerns about how the agency makes decisions.
Controversies about how the efficacy and safety of antidepressants are promoted have played a defining role in the discussions of conflict of interest in the bioethics literature, even if there is little attention to whether the best evidence actually indicates a risk for suicidality. However, more than has been acknowledged in this literature, debates about the safety of antidepressants have been clashes of conflicting financial interests. No doubt the drug companies producing the new antidepressants want us to believe that these drugs are absolutely safe and as dramatically effective as seen in the television commercials. They will spend enormous amounts of money to get their message across, including by enlisting key opinion leaders in psychiatry. Yet, there is big money behind the other side as well, though often undisclosed. For instance, take David Healy, whose "Normal Volunteers Study" of employees at his hospital given antidepressants has become the primary source for claims that even nondepressed persons became suicidal when they take SSRIs. He has widely been portrayed as a "self-effacing" hero fearlessly challenging the drug companies for the public good [Link]. Yet, at the time of his study, he was actually receiving substantial financial support, from Pharmacia a drug company attempting to capture a share of the SSRI market with a nonSSRI antidepressant [Link]. And the results of his study had immediate application in Healy's work as an expert witness in civil litigation, from which he has been making hundreds of thousands of dollars.
Healy had made his own contribution to the meta analysis of data concerning the safety of SSRIs, claiming to find that SSRIs were over 7 times more likely than other antidepressants to be associated with a fatal suicide attempt [Link]. This figure is comfortably over the odds ratio of 2.0 arbitrarily needed in the post-Daubert era to establish general causation in product liability. Unfortunately, readers showed that Healy's claims were contradicted by the data in his own article, and a correction was issued that acknowledged a lack of any differences between SSRIs and older antidepressants in terms of rates of fatal suicide attempts [Link]. Maybe financial interests sometimes do lead to distorted presentations of data.
Now that research data are available concerning SSRIs and suicidality, it might be time to revisit some of what has been said in the bioethics literature concerning the controversy in terms of conflict of interest and bias. A re-examination of the literature could lead to a more nuanced and sophisticated discussion of COI than has occurred so far.
