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
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