December 7

FDA Rescinds–Advisory Hearing on Suicide Opened to Speakers WhoWere Locked Out

Senior FDA-CDER officials who had attempted to lock out one third of the people who had signed up to speak at the FDA Psychopharmacologic Drugs Advisory Committee hearing about the risk of suicide for adults prescribed an SSRI antidepressant–were overruled!

We acknowledge the effort of the Deputy Commissioner to open the meeting.

The hearing is now open to everyone who had signed up by Nov. 21.

The issue before us now is to bring science back into the FDA drug reviewing process–so that 16 years do not have to elapse during which time thousands of preventable drug-induced suicides occurred before the FDA even examines the trials in its own drawers for lethal risk.

FDA has posted its analysis of 11 drugs that "represent the antidepressants approved in the last 25 years. The initial approval dates ranged from 1985 to 2004."

The problem is, they don't share the data–so how can we trust them after lying for 13 years by claiming "there is no evidence"?

FDA's analysis of 11 "second generation" antidepressants (SSRIs and SNRIs) that were approved between 1985 and 2004, has resulted in the acknowledgement that the drugs do pose a twofold increased risks of suicidal behavior (i.e., suicide attempts) in adults under <25–the odds ratio is 2.30 (Confidence Interval: 1.04 – 5.09) . 

However, in the same Table 18 the relative risk ratio is almost identical for ages 45 – 54: odds ratio is 2.29 (Confidence Interval:  0.73 – 7.14).

FDA's analysis is inconsistent with other analyses–including the British authority review which acknowledged completed suicides in the trials.
FDA 's analysis understates the data by selective inclusion.

Isn't it time to have a public debate with the scientists who had for 16 years attempted with no success to show FDA officials the data that validates patient advocates claim that antidepressants increase rather than decrease the risk of suicide.

How many preventable drug -induced casualties will it take before the FDA officials are held accountable for their failure to monitor or analyze drug safety hazards?

Our goal is to mandate that ALL clinical trial data involving human subjects must be posted on a publicly accessible website so that the interpretations of FDA-CDER officials can be validated or refuted.

FDA's failure to protect the public is more than just an issue to be debated for another 15 years– People's lives are at stake.

Two Press Briefings are planned to demonstrate the multiple flaws in FDA's methodology and to provide credible science-based information.

PRIOR to the FDA public hearing on Wednesday, Dec. 13, leading medical experts whose critical analyses have been VALIDATED through independent peer review–and by FDA's partial acknowledgement of the suicide risk– will comment about FDA's data analysis and about data the FDA has OMITTED from its analysis.

Internal FDA and drug company documents dating back to the mid-1980s, that have been under court-ordered seal will be shown. They tell the hidden story of the antidepressant suicide risk. 

Families who have suffered tragic losses of loved ones to drug-induced suicide will share their experience and their frustration in attempting to
deal with FDA officials who remain impervious to the human tragedy that they contribute toward.

Stay tuned for details:

What:   Press Briefing  #1:
When:    Tuesday, December 12, 2006

Place/Time:  9:00 AM – 11:00 AM

  National Press Club – First Amendment Lounge
  529 14th Street NW
  Washington DC 20045
  (202) 662-7500

  Press Briefing #2:
  4:00PM – 6:00PM

  Hilton Silver Spring — Assembly Room
  8727 Colesville Road
  Silver Spring, MD 20910

Contact: Vera Hassner Sharav
Contact:  Kim Witczak
(612) 877-0570

From: Cerny, Igor []
Sent: Wednesday, December 06, 2006 4:49 PM

Subject: Open Public Hearing for the December 13, 2006, Psychopharmacologic Drugs Advisory Committee

Due to the exceptional interest in the open public hearing for this meeting, the Agency has decided to expand the public hearing to accommodate all speakers who registered by the November 21, 2006 deadline (as specified in the Federal Register Notice that announced this meeting). Thus although you were initially not selected by the random lottery process, you may now use 3 minutes to speak at the open public hearing.

We apologize for this late notification. If you are indeed able to attend the meeting and wish to speak, you must notify Cicely Reese at either or by calling (301) 827- 6767. Remember, even if you are not able to attend, as long as you submitted written comments to either the LT. Reese the or Division of Dockets Management (HFA-305), Food and Drug Administration by the December 1, 2006, deadline (as specified in the Federal Register Notice that announced this meeting), your written comments will be considered by the Advisory Committee.
Thank you!

Igor Cerny, Pharm.D.
Director, Advisors and Consultants Staff
Office of Executive Programs
Center for Drug Evaluation and Research, FDA
5600 Fishers Lane, HFD-21
Rockville, MD 20857
(P) 301-827-6763; (F) 301-827-6778

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