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May 10, 2008, 04:13:13 PM
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ICSPP Media Release 2-2-04: A Challenge To The FDA To Make All Data Available on SSRI PDF Print E-mail

Media Release

 

Contact: 

            Dr. Dominick R. Riccio                                   Dr. Lloyd Ross

            Executive Director                                           U.S. Regional Director

            International Center For The Study                  International Center For The

           Of Psychiatry & Psychology                             Study Of Psychiatry & Psychology

           1036 Park Avenue                                             27 North Broad Street

           New York, New York 10028                            Ridgewood, New Jersey 07450

           (212) 585-3758                                                  (201)  445-0280

           E-Mail: DJRICCIO@aol.com                           LloydRoss1@WORLDNET.att.net

 

February 2, 2004

 

FOR IMMEDIATE RELEASE

 

A Challenge To The FDA To Make All Data Available on SSRI Antidepressants and Suicide

 

The Food and Drug Administration, in their review of the efficacy of SSRI medications for children which begins on February 2, 2004, has thus far refused to allow independent researchers to present their findings regarding the hazards and lack of benefits of these SSRI antidepressant drugs.  These independent researchers are not being allowed any time at the hearing to present their findings. 

 

The International Center For The Study of Psychiatry and Psychology, an independent research and educational network comprised of psychiatrists, psychologists, and leading mental health researchers is requesting that the FDA modify this hearing in three ways.

 

(1) Invite independent researchers such as Dr. David Healy and Dr. David Antonnucio to present their findings and recommendations.  This will allow respected researchers who do not represent the pharmaceutical companies who market these drugs to present independent findings.

 

(2) The FDA advisory committee that is to hear testimony on the SSRIs must be free of any conflicts of interest.  Anyone with current or previous ties to any of the pharmaceutical companies that market SSRIs present a clear conflict of interest. Backgrounds and financial ties of committee members must be publicly documented, unlike the 1991 FDA Prozac hearing in which 5 of the 9 committee members were given ?waivers? to participate in spite of their conflict of interest.

 

(3) According to the Washington Post, January 29, 2004, page A01, the makers of the SSRI antidepressants have refused to disclose the details of their clinical trials, describing them as ?trade secrets.?  The FDA must require this information to be made public.

 

We are calling on the FDA to restore public and professional confidence in the safety and integrity of the drug approval process.

 
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