Letters Suicidality and aggression during antidepressant treatment

Suicidality and aggression during antidepressant treatment: authors misinterpreted earlier paper from the FDA

BMJ 2016; 352 doi: https://doi.org/10.1136/bmj.i906 (Published 16 February 2016) Cite this as: BMJ 2016;352:i906
  1. Marc Stone1,
  2. physician
  1. 1Silver Spring, MD 20903, USA
  1. stonemarc{at}hotmail.com

Sharma and colleagues essentially duplicate, with more limited data, many of the analyses presented in our 2009 paper but seem not to have read our paper very carefully.1 2 They write, “The FDA did not consider the limitations of the trials that we identified and introduced some of their own—for example, by only counting events within 24 hours after the randomised phase was over.” Our event counts were based on individual adverse event reports because we were worried that the assessments by pharmaceutical sponsors may not have been accurate. Unlike the authors, we used a validated and standardised instrument to determine suicidal ideation or behaviour; their determinations seem to have been more subjective. As for the 24 hour “limitation,” this referred to the time of initial suicidal ideation or behaviour; someone who attempted suicide but who did not die from the attempt until several days later would have been counted—not much of a limitation.

As for their statement that “an FDA employee published a paper in 2001 using FDA data that showed 22 suicides in 22 062 patients randomised to antidepressants, which equates to 10 per 10 000 population, but in the large FDA meta-analysis five years later, five suicides were reported in 52 960 patients, or 1 per 10 000 population,” the “FDA employee” in question was the second author of our paper. The count of 22 suicides refers to all suicides in both placebo and treated groups, during open label extensions and studies. The count of five suicides refers only to people treated with antidepressants during double blind treatment periods.

Footnotes

  • Competing interests: None declared.

References

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