Dr. Ann Blake & FDA Committee Meeting Dec. 12th On Antidepressants!

[Guest guest]

Please keep Dr. Ann Blake and all those going before the FDA

committee on Tuesday. I want this to be a win situation for all of

us! Please pass on & forward to all those who believe in this cause.

Thanks.

~

Announcement of happenings as we gather at the FDA meeting

Posted by: " atracyphd2@... " atracyphd2@...

Sun Dec 10, 2006 10:53 pm (PST)

When we got together for the FDA meeting in Feb of 2004 Mathy

Downing was gracious enough to arrange with her country club for our

Drug Awareness group to meet and have dinner there. We have a

wonderful meeting with so many of us all gathering to share our

experiences and brainstorm about what steps we wanted to take in the

near future. This time when we attempted to do the same (this time

at the hotel) we quickly learned that all the meeting rooms had been

taken by either the pharmaceutical companies or the FDA. BUT we

still wanted

to get together the night before. Then Kim sent the following e-mail

with the suggestions below. The idea of bringing pictures is a great

one as well.

I think this sounds like a great idea and we should all get together

as a support to one another. For all of you who plan on being there

please let me know so that we will know to watch for you all.

Dr. Ann Blake , Executive Director,

International Coalition for Drug Awareness

http://www.drugawareness.org

and author of Prozac: Panacea or Pandora? - Our Serotonin Nightmare

and audio Help! I Can't Get Off My Antidepressant!

(Order Number: 800-280-0730)

*******PLEASE FORWARD**********

To all the families, friends, etc. of antidepressant tragedies:

This is a big week for all of us. We have the opportunity to make

sure the FDA hears us demand that black box warnings get extended to

people of ALL ages not just 25 and under as the FDA suggested last

week. It's also going to be an emotional week as we prepare to

relive and retell our stories - all of which could have been

prevented if the FDA and drug companies did the right thing 15 years

ago.

As a show of our solidarity, we have made buttons that we would love

for everyone to wear to the hearing. " We are not just anecdotes. We

matter. " This is a direct shot at the FDA who personally told us

that Woody's story and others including Medwatch reports are just

anecdotes and the FDA needs to prove things scientifically since

they are a scientific organization. These buttons will make our

group easily identifiable to the members of the media, the FDA and

its panel members, and their drug company friends. Also, if you have

a photo of your loved one and want to make a photo button to wear,

please bring a photo or color copy that could be cut down to fit

into 4 " button. We will have blank buttons for you.

So, let's all gather together Tuesday evening at the hotel lobby/bar

like we did in 2004. Its totally informal and a great way to meet,

greet, and

offer support to each other before the hearing. We will also have

the buttons there for you to pick up. Also, there will be two press

briefings

on Tuesday where experts like Dr. Healy and Dr. Glenmullen will be

pointing out issues and flaws in the FDA meta analysis to the media

the

day before the hearing. The 2nd press event is at the hotel from 4-

6PM. Details in the attached email.

Please pass onto everyone you know who will be attending or even if

they are not able to attend. We could use all the support and well

wishes. Let's hope the FDA does the right things so that no other

family has to experience what we all have.

If you have any questions, please feel free to call me on my cell

612-877-0570.

See you Tuesday!!!

Kim Witczak and Swan

http://www.woodymatter.com (http://www.woodymatter.com/)

Using Woody's life and death to save others. Be smart. Be informed.

______________________________________

From: VERACARE [mail to:veracare@...]

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

_infomail1@..._ (mailto:infomail1@...)

Subject: FDA Rescinds--Advisory Hearing on Suicide Opened to

Speakers Who

Were Locked Out

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

_http://www.ahrp.org_ (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 & #8232;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 & #8232;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_

(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