Evidence of Drug Harm that the FDA Sought to Suppress

Evidence of Antidepressant Harm that the FDA Sought to Suppress from FDA’s Public Advisory Committee Meeting on February 2

Evidence was presented on February 2 at AHRP’s press briefing by the following scientists:

• David Healy, MD, Director of the North Wales Department of Psychological Medicine and Visiting Professor, University of Toronto:
  Analysis of Suicidality Evidence (ppt, 1.8 MB file)
  What GSK really thinks about Paxil for Children
• Irving Kirsch, Ph.D, Professor of Psychology University of Connecticut and David Antonuccio, Ph.D, Professor of Psychiatry and Behavioral Sciences University of Nevada School of Medicine:
  Is there evidence of efficacy in published reports?
• Thomas J. Moore, Health Policy Analyst, George Washington University Medical Center:
  Study 1: Safety concerns: increased use in children (pdf)
  Study 2: Evidence of increased suicidal / aggressive behavior (pdf)
  (available at: http://drugsafetyresearch.com/pages/library_main.htm )
• Joseph Glenmullen, MD, Clinical Instructor in Psychiatry, Harvard University:
  SSRIs, Akathisia, and Suicidality (ppt, 2.7 MB file)
• Donald H. Marks, MD, Ph.D, Consultant on pharmaceutical industry and drug adverse effect issues, Extant Medical Legal Consulting, LLC:
  SSRIs, Akathisia, and Suicidality (ppt, 3.8 MB file)

AHRP’s written testimony: Where is the Scientific Evidence to Justify Exposing Children to the Risks of Antidepressant Drugs?

FDA Background Memorandum Jan 5, 2004, for Advisory Committee Meeting Re: Suicidality Associated with Antidepressant Drug Treatment.

AHRP correspondence with FDA demonstrating that the FDA would not permit this evidence to be presented at the public hearing:

Feb. 19. Dr. David Healy letter to FDA: updated suicidal evidence not addressed by FDA