Comments on: FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications http://www.bioethicsinternational.org/blog/2007/05/02/fda-proposes-new-warnings-about-suicidal-thinking-behavior-in-young-adults-who-take-antidepressant-medications/ Where Healthcare, Life Science & Ethics Meet Sun, 22 Aug 2010 18:34:47 -0700 http://wordpress.org/?v=2.8.5 hourly 1 By: Jeffrey Dach http://www.bioethicsinternational.org/blog/2007/05/02/fda-proposes-new-warnings-about-suicidal-thinking-behavior-in-young-adults-who-take-antidepressant-medications/comment-page-1/#comment-490 Jeffrey Dach Sun, 17 Jun 2007 14:03:36 +0000 http://www.bioethicsinternational.org/?p=119#comment-490 According to <a href="http://psycinfo2.apa.org/doi/index.cfm?doi=10.1037/1522-3736.5.1.533r" rel="nofollow">Dr. Irving Kirsch in Prevention & Treatment</a>, “there is now unanimous agreement that the mean difference between response to SSRI antidepressant drugs and response to inert placebo is very small. It is so small that, despite sample sizes involving hundreds of participants, 57% of the SSRI trials funded by the pharmaceutical industry failed to show a significant difference between drug and placebo. Most of these negative data were not published and were accessible only by gaining access to US Food and Drug Administration (FDA) documents. Various methods were used to manipulate the results of SSRI drug studies to insure a favorable outcome: 1) Responders to the placebo are eliminated at the beginning of the study. (Placebo washout) 2) Benzodiazepine sedatives were given to mask the SSRI induced agitation. 3) Unfavorable drug studies are buried in the file cabinet and not disclosed to the public. 4) Miscoding suicidal events as "emotional lability", and homicidal events as "aggression" to hide suicidal events from regulators. 5) False attribution of suicide to the placebo arm. 6) Hiring ghost writers to make the medical articles more favorable. 7) Cash settlements for SSRI drug litigants which seals records and withholds unfavorable drug studies from the public. For more information and links see my <a href="http://jeffreydach.com/2007/05/14/paxil-prozac-and-ssri-induced-suicide-by-jeffrey-dach-md.aspx" rel="nofollow">Paxil, Prozac, and SSRI Induced Suicide Newsletter</a> <a href="http://www.drdach.com/" rel="nofollow">Jeffrey Dach MD</a> According to Dr. Irving Kirsch in Prevention & Treatment, “there is now unanimous agreement that the mean difference between response to SSRI antidepressant drugs and response to inert placebo is very small. It is so small that, despite sample sizes involving hundreds of participants, 57% of the SSRI trials funded by the pharmaceutical industry failed to show a significant difference between drug and placebo. Most of these negative data were not published and were accessible only by gaining access to US Food and Drug Administration (FDA) documents.

Various methods were used to manipulate the results of SSRI drug studies to insure a favorable outcome:

1) Responders to the placebo are eliminated at the beginning of the study. (Placebo washout)

2) Benzodiazepine sedatives were given to mask the SSRI induced agitation.

3) Unfavorable drug studies are buried in the file cabinet and not disclosed to the public.

4) Miscoding suicidal events as “emotional lability”, and homicidal events as “aggression” to hide suicidal events from regulators.

5) False attribution of suicide to the placebo arm.

6) Hiring ghost writers to make the medical articles more favorable.

7) Cash settlements for SSRI drug litigants which seals records and withholds unfavorable drug studies from the public.

For more information and links see my Paxil, Prozac, and SSRI Induced Suicide Newsletter

Jeffrey Dach MD

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