THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

142 West End Ave. Suite 28P
New York, NY 10023
January 27, 2004

***PRESS BRIEFING***

When: February 2, 2004, 11:45 - 1:45
Where: Holiday Inn, Bethesda, site of FDA's Advisory Committee Meeting (8 AM to 5 PM)
Re: Antidepressants and reports of suicidal risks for children
Specifically: AHRP Press Briefing in the Potomac Room, 1st Mezzanine

The British drug authority has banned the use of most SSRI antidepressant drugs for the treatment of depression in children under 18, citing a two-to-threefold increased risk of suicidal behavior and lack of evidence of a benefit for depressed children. Two SSRIs - Paxil and Effexor - are no longer recommended by their manufacturer for use in children. Prozac is no longer recommended by Eli Lilly for children in the U.K.

In contrast to the British medicines authority review of the evidence, the FDA has refused to allow independent scientists to present documented evidence related to these drugs' hazards and their failure to demonstrate a benefit for depressed children. In a recent background memorandum for the February 2 advisory committee meeting, the FDA cites only published references favorable to the SSRIs, with the exception of one - the very first article to raise concerns about an SSRI drug-induced suicide risk, published in 1990. Furthermore, the FDA has enlisted the help of scientists and institutions with major financial ties to the companies whose drugs are under scrutiny.

The Alliance for Human Research Protection (AHRP) believes that the integrity of science and scientific discourse depends upon a fair and open examination of all of the evidence so that it can be independently verified. To facilitate an open and fair discourse, AHRP is sponsoring a press briefing by prominent, independent, scientific experts who are concerned about the effectiveness and safety of these widely used drugs in children.

Among the distinguished scientists who will present their original documented analyses and / or summaries of scientific evidence from a variety of sources - including never disclosed clinical trial data:

• David Healy, MD, Director of the North Wales Department of Psychological Medicine and Visiting Professor, University of Toronto
• Irving Kirsch, Ph.D, Professor of Psychology University of Connecticut
• David Antonuccio, Ph.D, Professor of Psychiatry and Behavioral Sciences University of Nevada School of Medicine
• Thomas J. Moore, Health Policy Analyst, George Washington University Medical Center
• Joseph Glenmullen, MD, Clinical Instructor in Psychiatry, Harvard University.
• Donald H. Marks, MD, Ph.D, Consultant on pharmaceutical industry and drug adverse effect issues, Medical Legal Consulting, LLC.

The evidence to be disclosed at the briefing- some for the first time - will shed new light on the scope and nature of the life-threatening risks these drugs pose for some children. For example, Dr. David Healy, whose compelling evidence led to the recent British review of these drugs' safety, has prepared an updated analysis. Based information in company documents, he compares rates of suicidality and aggression in children and adolescents in placebo controlled SSRI trials. Based on company documents, he will offer an analysis of why the data on hazards has been so slow to emerge. The FDA has not answered any of his requests to participate in their review.

Thomas J. Moore has just completed two studies about the safety of antidepressant drugs in children. The first study reveals that antidepressant use in children doubled in just four years, and identifies new safety concerns. The second study shows suicidal/aggressive behaviors occurred more frequently than expected among children taking any of the leading antidepressant drugs.

All of these presentations are posted on the AHRP website as of noon, Monday, Feb. 2, 2004.

AHRP believes the scientific validity of FDA's limited review and reliance on psychiatrists with financial conflicts of interest, is suspect and may be calculated to minimize the scope of the problem.

Following the scientists' presentations, Lisa Van Syckel, whose daughter attempted suicide after being prescribed an SSRI, will be leading a panel of families whose children suffered life-threatening drug effects. A father will testify that he lost his 13-year old son after he was prescribed an SSRI because he had trouble adjusting to a new school. The boy, with no history of depression, hanged himself 7 days after taking the drug. A teenager who was prescribed an SSRI for migraine headaches describes the drug's harrowing effects that led her to attempt suicide. Adult survivors of drug-induced suicide attempts when they were teenagers will speak as well.

AHRP Statement, Press Briefing

Reply to the American College of Neuropharmacology's Report on SSRI and Suicidal Behavior in Children - Jonathan Leo, Ph.D.

FDA Sham Conflicts of Interest Policy