ALLIANCE FOR HUMAN RESEARCH PROTECTION
(AHRP)

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

***PRESS RELEASE***

September 11, 2004

Contact: Vera Hassner Sharav, President, AHRP
Tel. No: 212-595-8974
Cell: 917-375-5083

***AHRP PRESS BRIEFING***

Re: Antidepressants and suicide-related risks for children

When: September 14, 2004, 12:00 P.M.

Where: Holiday Inn, Bethesda, site of FDA's Advisory Committee Meeting

Specifically: Washington Room opposite FDA's

The FDA bears responsibility for a credibility crisis in medicine. The FDA has allied itself with the pharmaceutical industry, adopted that industry's culture of arrogance and concealment of evidence - even as children's life-safety were put on the line. The hazardous side-effects of SSRI antidepressants were concealed for 25 years with FDA's tacit approval - lest the truth impede industry's mega-profit goals. Indeed, FDA's limited review of selective evidence, its reliance on information supplied by psychiatrists with financial conflicts of interest, and the invited presentations by Pfizer and Eli Lilly, are calculated to minimize the scope of the problem.

The Alliance for Human Research Protection will convene a press briefing at which five independent experts will review scientific and clinical evidence, shedding light on what was known 20 years ago, what is known and not known today about the safety and efficacy of antidepressant drugs.

The issues to be addressed at the press briefing, and the documented evidence presented, will not be explored by the FDA advisory committee meeting - inasmuch as independent analysts were excluded from the discussion. All critical analyses and reports from outside independent experts have been excluded from the committee deliberations - much as Dr. Mosholder's report and recommendations were suppressed for six months - until it was made public by The Alliance for Human Protection who posted it on its website in July.

The five independent expert presenters are:

• Peter Mansfield, MD, University of Adelaide (Australia), Director of Healthy Skepticism will discuss the illusion of potency in light of the meta-analyses in the British Medical Journal (which he co-authored) and the Lancet
  
  
• Peter Breggin, MD, a psychiatrist with a sub-specialty in clinical psychopharmacology, who was among the first to recognize adverse antidepressant drug reactions
  
  
• Lawrence Diller, MD, a pediatrician and family therapist who has evaluated and treated more than 2,500 children
  
  
• Stefan Kruszewski, MD, a clinical and academic psychiatrist, and Associate Medical Director of Physicians' Health Programs, Pennsylvania Medical Society, who will discuss the impact of over-prescribing SSRIs for children in state custody
  
  
• David Healy, MD, Director of the North Wales Department of Psychological Medicine and Visiting Professor, University of Toronto, who in large measure has brought pressure to bear on the FDA to examine the pediatric data. Dr Healy will shed light on FDA's asymmetric standards for evaluating efficacy and safety, and will present newly uncovered documents.

Children's lives have been been put on the line by concealed hazardous side-effects of SSRI antidepressants. The FDA lent its support to the least forthcoming drug manufacturers--even exerting pressure on companies that were willing to disclose suicide-related risks on their antidepressant drugs labels. FDA officials forced Wyeth and Forest to toe the line.

Following the independent experts' presentations, questions from members of the press will be answered. Families will also share experiences that show the chilling reality of the life-threatening consequences of SSRI antidepressant drug use in children and adolescents.

See also:

Senator Chuck Grassley's letter, Sept. 7, 2004, to HHS Sec. Tommy Thompson and FDA Acting Commissioner, Lester Crawford, about FDA's failure to disclose documents and intimidation of agency employees.

http://finance.senate.gov/press/Gpress/2004/prg091004.pdf

September 7, 2004
The Honorable Tommy G. Thompson
Secretary
Department of Health and Human Services
Hubert Humphrey Building, Room 416 G
200 Independence Avenue, SW
Washington, D.C. 20201

Mr. Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane, Room 1547
Rockville, MD 20857

Dear Secretary Thompson and Dr. Crawford:

Since May 4, 2004, the Food and Drug Administration (FDA) has responded incompletely to my requests for information related to whether the FDA is effectively addressing drug safety concerns, and protecting the public health at the level expected by the American people. Specifically, for several months now my Committee staff has reviewed, among other concerns, whether the FDA suppressed an analysis completed by Dr. Andy Mosholder about the possible link between antidepressants and suicide among children and adolescents. While some information has been provided on a timely basis, quite a number of requests remain outstanding and deadlines have long ago passed.

Dr. Crawford, when we met awhile ago, you assured me that the FDA would respond completely and cooperate fully with the Committee on these matters. Further, my Committee staff reached an agreement with FDA staff that information and documents would be provided consistently on a "rolling basis." However, as I have stated previously, the FDA continues to delay and provide incomplete information and responses. Accordingly, I would appreciate your immediate attention to these outstanding requests:

1. On May 18, 2004, I requested that the FDA supply a number of documents regarding Dr. Mosholder's report on antidepressants. The FDA responded to this request on July 12th and July 28th. However, the FDA did not respond to question #6 in my letter dated May 18th.
   
   Specifically, I requested all e-mails regarding the contents and findings of Dr. Mosholder's report on SSRIs. I asked that the FDA include all e-mails written by Drs. Mosholder, Seligman, Trontell, Avigan, Temple, Jenkins, Katz, and Laughren. This response was due on May 28th - more than three months ago.
   
   
2. On June 1, 2004, I asked that the FDA advise its employees that they have the right to speak directly to Congress or to a Committee of Congress without interference. After the FDA failed to address this request, I asked again in a July 2nd letter. It is now September and I have not yet heard from the FDA whether it will notify its employees that they are free to speak to me, to my staff members and to Members of Congress without fear of reprisal.
   
   
3. On June 3, 2004, I requested that the FDA provide all documents and correspondence between the Office of Drug Safety and GlaxoSmithKline (GSK) regarding the antidepressants, Paxil. In addition, I requested all documents and correspondence between Dr. Mosholder and GSK regarding the data GSK submitted to the FDA on Paxil. The FDA has failed to respond to either of these requests that were due on June 14th.
   
   
4. On July 23, 2004, I sent the FDA a detailed list of questions and documentation requests regarding the following:
   a) the Columbia University Reclassification Study;
   b) FDA's July 2nd response to my May 11th letter;
   c) the organizational structure of the Office of New Drugs and the Office of Drug Safety;
   d) potential conflicts of interest in the Office of the Chief Counsel;
   e) FDA's Independent Validation and Verification process for clinical trial data; and
   f) recent news reports regarding the alleged concealment of safety data by drug manufacturers.

My letter dated July 23rd set a deadline of July 30th and the FDA has failed to respond to this inquiry entirely. In addition, some of these questions are repeated from my letter dated May 11th, which was due in full on June 7, 2004. My letter dated July 2, 2004, also brought up the issue of outstanding document requests and long overdue deadlines.

In closing, I request the aforementioned documentation immediately. While some delay may be unavoidable and even understandable, months of delay and a pattern of incomplete responses and information is not consistent with your personal assurances to me. Reasonable extensions of time may be appropriate at times, but the FDA cannot simply side-step its responsibilities to Congress. FDA's response to date and further delay is simply unacceptable.

Please have your staff coordinate with my staff regarding this letter by Friday, September 10th. Thank you in advance for your written response by September 17, 2004, unless it is available sooner. In responding to my requests, please repeat each numbered request, followed by its accompanying response. In the event that documents or other materials are requested, please be sure to mark them accordingly.

Sincerely,
Charles E. Grassley
Chairman