In the New England Journal of Medicine, Richard Friedman and Marc Stone present very different arguments about the reliability of the body of research into antidepressants, suicidality, and FDA black box warnings, and what that body of research is truly telling us.
Friedman concludes: “Given that the agency’s 2007 modification of the black-box warning has not been sufficient to prevent what seems to be a chilling effect on depression treatment — perhaps the mere presence of a warning speaks louder than any clarification it may contain — I believe it’s unlikely that further modification would be helpful. I would therefore argue that the FDA should consider removing the warning entirely.”
However, virtually all of the scientific evidence that Friedman relies on is raised into question by Stone, who concludes, “These data should be sufficient to dispel any serious concerns, but nearly 10 years after the labeling changes, the idea that the boxed warning had adverse consequences persists in the minds of many health professionals, in the media, and among the general public. Because thousands of data sources, geographic areas, time frames, and outcome measures can be examined, continued pursuit of this question will probably provide additional examples that achieve little beyond reinforcing concerns about something that did not happen.”
The FDA Warning on Antidepressants and Suicidality — Why the Controversy? (Stone, Marc B. N Engl J Med. October 30, 2014. DOI: 10.1056/NEJMp1411138)
Antidepressants’ Black-Box Warning — 10 Years Later (Friedman, Richard A. N Engl J Med. October 30, 2014. DOI: 10.1056/NEJMp1408480)
Upon Further Review: Did the Black Box Warning on SSRIs Lead to Increased Suicide Attempts in Youth? (Mad In America, June 23, 2014)