: FDA Rescinds--Advisory Hearing on Suicide Opened to Speakers Who Were Locked Out

[Guest guest]

VERACARE <veracare@... <veracare%40ahrp.org>> wrote:

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org

FYI

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'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?

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. "

http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4272b1-01-FDA.pdf

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 " ?

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

(301)589-5200

Contact: Vera Hassner Sharav

212-595-8974

veracare@... <veracare%40ahrp.org>

woodymatters.com

Contact: Kim Witczak

(612) 877-0570

~~~~~~~~~~~~~~~~~~~~~~~~~~~~

From: Cerny, Igor [mailto:igor.cerny@... <igor.cerny%40fda.hhs.gov>]

Sent: Wednesday, December 06, 2006 4:49 PM

veracare@... <veracare%40ahrp.org>

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

Cicely.Reese@... <Cicely.Reese%40fda.hhs.gov> 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

igor.cerny@... <igor.cerny%40fda.hhs.gov>

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