On June 18, 2014, the British Medical Journal published a report by Harvard Medical School researchers that the black box warning on SSRIs had paradoxically led to an increase in suicide attempts by youth. In their conclusion, the researchers wrote: “Safety warnings about antidepressants and widespread media coverage decreased antidepressant use, and there were simultaneous increases in suicide attempts among young people.”
What the Researchers Found
The study appeared online in the British Medical Journal. The researchers, led by Christine Lu, found that following the FDA’s black box warning, there was a slight decrease in antidepressant use in a cohort of 1.1 million adolescents (ages 10 to 17). At the same time, there was an increase in the number of youth from that cohort who were treated at a hospital or emergency room for “psychotropic drug poisoning,” which they regarded as a proxy for a suicide attempt. Two years after the warning, there was an increase of 2 to 4 poisonings per 100,000 youth in their cohort. The researchers did not find any increase in completed suicides.
How the Media Reported The Story
Here’s how various media reports framed the significance of the research:
NBC News: “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.”
Bloomberg: “A widely publicized warning by U.S. regulators a decade ago about risks for teenagers taking antidepressants led to plummeting prescriptions and increased suicide attempts.”
Washington Post: “Government warnings a decade ago about the risks associated with children and adolescents taking antidepressants appear to have backfired, causing an increase in suicide attempts and discouraging many depressed young people from seeking treatment, according to a study published Wednesday in the academic journal BMJ.”
• The FDA issued its warning after finding that in randomized clinical trials, which are supposed to be the gold standard in research, antidepressants doubled the risk of suicidal ideation in children and adolescents. Why is this study, which tells of a correlation, now seen as trumping the RCT findings?
• How significant is an increase of two to four drug poisonings per 100,000 youth, with no increase in actual suicides?
• Anecdotal accounts of youth committing suicide on SSRIs, or attempting suicide while on antidepressants often involve violent acts: hangings, etc. This study, by focusing only on “drug poisonings,” would not see such drug-induced suicide attempts. Why didn’t the researchers explore this fact?
• There has been a notable increase in the use of other psychotropic drugs, and also abuse of oxycontin, heroin, and other painkillers. Could this have accounted for the increase in drug poisonings—two to four per 100,000—reported by the Harvard researchers. Why didn’t they discuss this possibility?
• Why did NBC News, Bloomberg and other news media outlets report that this study showed causation? Why did so many not question whether the authors’ conclusions were justified?
In the British Medical Journal
- Mark Olfson, Columbia University & Michael Schoenbaum, National Institute of Mental Health
- Adrian Preda, University of California Irvine
- Peter Gøtzsche, Nordic Cochrane Center
- Glen I. Spielmans, Metropolitan State University
- David T. Healy, Bangor University
- Bernard J. Carroll 1, and 2, Pacific Behavioral Research Foundation
- Dee Mangin, McMaster University
- Thomas J. Moore, Institute for Safe Medication Practices
- Brady Case, Brown University
- Gerald Gaines, Depression Recovery Centers
- Kristina K. Gehrki
- JK Anand
- Robert O Bartlett, Hergest Unit
John M. Nardo, Emory University (retired)
- Catherine W. Barber & Matthew Miller & Deborah Azrael, Harvard School of Public Health
- Selling Sickness
- Baum, Hedlund, Aristel, & Goldman Attorneys
- PLOS Blogs, Adrian Preda
- 1 Boring Old Man
- Behaviorism and Mental Health, Philip Hickey 1 and 2
Our Conclusion (July 17, 2014)
Once the criticisms of this study are reviewed, as has been done by critics writing in the British Medical Journal, it is clear that it should not have been published. It adds an unwarranted conclusion to the body of scientific evidence, and one that has the potential to do considerable harm. Here are some of the paper’s substantial flaws:
• The number of hospitalizations or treatment in an emergency room due to psychotropic drug poisoning is not a good proxy for suicide attempts.
• The coding for psychotropic drug poisoning included youth that had been “poisoned” by SSRI antidepressants, stimulants, and other psychotropic drugs. Thus, this metric could best be seen as providing information related to potential risks from the use of psychotropic drugs; there is no suicidal data on youth who weren’t using psychotropic drugs. A teenager or young adult who was depressed and didn’t use a psychotropic drug, but tried to commit suicide by some other means, wouldn’t even show up in this database of psychotropic drug poisonings.
• The researchers’ stated conclusion, which was that a decrease in antidepressant prescribing in youth following the black box warning led to an increase in suicide attempts, isn’t supported by their own data. (1) There was not a significant decrease in SSRI prescriptions to teenagers and young adults following the black box warning. (2) Psychotropic drug poisonings are not a good proxy for suicide attempts. (3) This coding category actually tells of poisonings due to the use of psychiatric drugs, as opposed to their non-use. (4) Finally, there was no significant increase in the number of poisonings.
• Other evidence and evidence using more reliable proxies show suicide attempts and suicidal behaviors in youth did not increase during the time frames analyzed.
Based on this flawed research, newspapers published a story that creates a damaging misconception, which is that SSRIs appear to protect against suicide attempts in depressed teenagers and youth, when randomized clinical trials showed the opposite. As such, this study may lead to an increase in the prescribing of SSRIs to youth and young adults, which–based on the RCT data– will expose them to an increased risk of suicide.