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Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: quasi-experimental study

BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g3596 (Published 18 June 2014) Cite this as: BMJ 2014;348:g3596

Misleading the public

This article has already done a great deal of damage to the public health. People far more qualified than I have outlined the flaws in the data and methods, which I won’t repeat. But I feel compelled to speak out about the authors’ showcasing of “relative” figures. Instead of simply comparing actual antidepressant use in children before and after the FDA warning, they compared the rate of use post-warning with what they project it would have been if antidepressant use had continued to grow at the rate it did in the early years. While those who read the article with great care, and are well-versed in statistical methods, may understand the difference, the confusion it caused in the popular press was completely predictable.

Here is the news the public woke up to on June 18 as a result:

A so-called “black box” warning on antidepressants that the medications increase the risk of suicidal thinking and behavior in kids may have had a horrible side-effect. New research finds the warning backfired, causing an increase in suicide attempts by teens and young adults.

After the FDA advisories and final black box warning that was issued in October 2004 and the media coverage surrounding this issue, the use of antidepressants in young people dropped by up to 31 percent, according to the study published Wednesday in the British Medical Journal.

That drop in use resulted in a 22 percent increase in suicide attempts among adolescents and a 34 percent increase among young adults shortly after the warning, explains study senior author Stephen Soumerai, professor of population medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute. (1)

The authors are aware that these figures gravely misrepresent their findings about what happened in the wake of the FDA warnings. I realize they may have limited control over what NBC News or the Chicago Tribune say about their work. However, surely they could exert some influence over the press releases put out by the Harvard Medical School. (2,3) Ditto the press releases of NAMI (the National Alliance on Mental Illness) (4) and the American Foundation for Suicide Prevention (AFSP) (5) , two hugely influential nonprofits which were co-founded by, or have day-to-day access to, the leading figures in American psychiatry. All these outlets have repeated the flawed, alarmist figures word for word. Did those who knew better make any effort to help the general public do the math? Just the opposite.

The AFSP’s Chief Medical Officer, Dr. Christine Moutier, has openly called on the FDA to withdraw the black-box warning, an appeal which was featured on national TV news. The alleged “33 percent jump in suicide attempts” was cited by her fellow guest, Dr. Gene Beresin of Massachusetts General Hospital’s Clay Center for Healthy Young Minds. If asthma, heart attacks or any other medical condition were to increase by over 30% in such a short time, “the public would go ballistic,” he told ABC News’ Good Morning America. (6)

The authors of this study – and now, the BMJ as well – have a moral responsibility to do what they can to correct these serious distortions. Fifteen years ago, troubled teens might have faced a doctor who, relying on the peer-reviewed journals, had heard very little about the potential for suicidal thoughts and behaviors in adolescents given SSRI’s. Soon they may turn to doctors who have been effectively inoculated against taking those warnings seriously – once again, thanks to the “guidance” of the peer-reviewed journals. Haven’t “studies shown” that those warnings were a tragic mistake? they will ask. As a result they will be unable to recognize such reactions when they see them first-hand, or take the necessary steps to keep their patients safe.

1. “Black Box” warning on antidepressants raised suicide attempts, by Joan Raymond. NBC News, June 18, 2014 http://www.nbcnews.com/health/kids-health/black-box-warning-antidepressa... (accessed August 7, 2014)

2. Unintended danger from antidepressant warnings, by Jake Miller. Harvard Medical School News, June 18, 2014 http://hms.harvard.edu/news/health-care-policy/unintended-danger-antidep... (Accessed August 9, 2014)

3. Opinion: Time to lift the black box warning on antidepressants, by Steve Schlozman and Gene Beresin. Harvard Medical School News, July 2, 2014 http://hms.harvard.edu/news/opinion-time-lift-black-box-warning-antidepr... (Accessed August 9, 2014)

4. Did FDA Black Box warnings actually lead to an increase in suicides? By Kelly Todd. National Alliance on Mental Illness, undated. http://www.nami.org/template.cfm?Section=home%20&template=/ContentManage... (Accessed August 7, 2014)

5. Op-Ed: “Black Box” warning. American Foundation for Suicide Prevention, June 18, 2014 https://www.afsp.org/news-events/in-the-news/op-ed-black-box-warning (Accessed August 7, 2014)

6. Doctors call: End antidepressant warnings or risk suicides July 9, 2014 Susan Donaldson James, ABC News http://abcnews.go.com/Health/doctors-call-end-warning-antidepressants-ri... (Accessed August 7, 2014)

Competing interests: No competing interests

11 August 2014
Johanna Ryan
paralegal
RxISK.org
Chicago, USA