Discussion of antidepressant black-box warnings and youth suicide

By | May 2, 2018

In many situations, randomized controlled trials are infeasible and one must draw conclusions from observational data.  Certain quasi-experimental designs – for example, interrupted time series analyses – strengthen the conclusions that can be drawn from observational data.  However, particularly when the intervention evaluated is important, either clinically or from a health policy perspective, implied or explicitly stated conclusions about causality often give rise to great controversy.

This month’s issue of Medical Care features an exchange between Dr. Marc Stone (and here) of the Food and Drug Administration and Professor Christine Lu and colleagues (and here) from Harvard University. The exchange focuses on the impact of the FDA boxed warnings and subsequent media attention on antidepressant treatment of youth and whether there was a resulting increase in youth suicide attempts.  The exchange highlights the types of the issues that arise when attempting to draw causal conclusions from observational data:

  • the appropriateness of different databases and research designs for different purposes;
  • the validity of proxy measures;
  • competing hypotheses to explain observed trends; and
  • the strengths and weaknesses of interrupted time series designs to identify potential causal relationships.

We have created this moderated forum to provide a place for continued discussion of the issues raised by both Dr. Stone and Professor Lu and colleagues. We encourage all commenters to be civil and respectful. Our hope is that this forum will allow for meaningful exchanges among researchers and other stakeholders in this debate.

Michael Shwartz

Michael Shwartz is the Richard D. Cohen Professor in Management at the Questrom School of Business, Boston University and is a Senior Investigator at the VA Center for Healthcare Organization and Implementation Research. He has done work in disease screening, risk adjustment, health care costs and outcomes, quality of care, small area variations, substance abuse, organizational analyses and provider profiling. Much of his current work focuses on quality and patient safety measurement and the role and potential of composite measures. He has recently completed a large grant evaluating the impact on quality and safety culture and measures in 6 VA hospitals of actively engaging senior leadership with front-line staff in order to identify and prioritize quality improvement interventions.

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About Michael Shwartz

Michael Shwartz is the Richard D. Cohen Professor in Management at the Questrom School of Business, Boston University and is a Senior Investigator at the VA Center for Healthcare Organization and Implementation Research. He has done work in disease screening, risk adjustment, health care costs and outcomes, quality of care, small area variations, substance abuse, organizational analyses and provider profiling. Much of his current work focuses on quality and patient safety measurement and the role and potential of composite measures. He has recently completed a large grant evaluating the impact on quality and safety culture and measures in 6 VA hospitals of actively engaging senior leadership with front-line staff in order to identify and prioritize quality improvement interventions.