[drugawareness] Congress Puts FDA Under Fire Over Antidepressants

[Guest guest]

> atracyphd2

> Thu, 9 Sep 2004 22:11:35 EDT

> [drugawareness] Congress Puts FDA Under

> Fire Over Antidepressants

>

> Sorry about the notice today on listening to the

> Congressional hearing live.

> They let us know at the very last minute that it

> would not be available after

> all. Considering all that happened today it is a

> shame that we could not

> listen in today.

>

> The article below will give you an idea of what

> happened and how very

> aggressive the Congressmen were in searching for

> answers to the questions we all have

> about these drugs and what has happened in this

> country as a result.

>

> I applaud Rep. Barton in his efforts along with all

> those on the subcommittee

> who worked so hard to gather the information for

> this hearing. And I would

> encourage all of you to thank those involved.

>

> Dr. Tracy

> ______________

>

> Ann Blake Tracy, Ph.D.,

> Executive Director, International Coalition For Drug

> Awareness

> Author: Prozac: Panacea or Pandora? - Our Serotonin

> Nightmare & audio tape on

> safe withdrawal: " Help! I Can't Get Off My

> Antidepressant! "

> Order Number: 800-280-0730

> Website: www.drugawareness.org

>

>

> “Unfortunately, over the last several months, the

> committee has been met

> mostly with stonewalling, slow-rolling and plain

> incompetency from the FDA,†said

> Barton, of Texas.

>

> The committee asked the agency to supply lawmakers

> with all related

> documents, but an FDA employee decided to limit the

> number of records it sent, Barton

> charged.

>

> If necessary, “we will send committee staff to the

> FDA with the (U.S.)

> Capitol Police ... and we will go through the files

> ourselves,†he said.

>

>

> FDA under fire in antidepressant case

> Lawmaker says agency has been uncooperative

>

> http://www.msnbc.msn.com/id/5953983/

> Â

> Reuters

> Updated: 6:59 p.m. ET Sept. 9, 2004

>

> WASHINGTON - A top Republican lawmaker Thursday

> charged the Food and Drug

> Administration with hindering a congressional

> investigation into whether the

> agency suppressed a possible link between

> antidepressant use and suicidal behavior

> in youth.

>

> Rep. Joe Barton, chairman of the House Energy and

> Commerce Committee, said

> the FDA has been uncooperative during the

> committee’s inquiry, which began as a

> general probe into the risks of the mood-enhancing

> medicines in children and

> teens.

>

> “Unfortunately, over the last several months, the

> committee has been met

> mostly with stonewalling, slow-rolling and plain

> incompetency from the FDA,†said

> Barton, of Texas.

>

> The committee asked the agency to supply lawmakers

> with all related

> documents, but an FDA employee decided to limit the

> number of records it sent, Barton

> charged.

>

> If necessary, “we will send committee staff to the

> FDA with the (U.S.)

> Capitol Police ... and we will go through the files

> ourselves,†he said.

>

> Dr. Janet Woodcock, FDA’s acting deputy

> commissioner for operations, said the

> agency had supplied the requested documents and the

> “FDA will make every

> effort to cooperate with the committee.â€

>

> She also said committee investigators had declined

> invitations to review

> documents at the FDA but were still welcome to do

> so.

>

> Seven months ago, the committee began probing

> whether the widely used drugs

> would increase the risk of children and teenagers

> committing suicide, prompted

> by the agency review of the medicines.

>

> One FDA reviewer, Andrew Mosholder, concluded there

> was a link, but other

> agency officials disagreed and decided Mosholder

> should not present his views at

> an advisory committee meeting held earlier this

> year.

>

> Questions about a possible link first arose last

> year when regulators

> reviewed clinical trials of children who took

> GlaxoSmithKline Plc’s Paxil. Only Eli

> Lilly and Co.’s Prozac, sold generically as

> fluoxetine, is approved for

> treating pediatric depression.

>

> The agency review also includes Pfizer Inc.’s

> Zoloft, Forest Laboratories Inc.

> ’s Celexa, Wyeth’s Effexor, Bristol-Myers

> Squibb’s Serzone, Solvay’s Luvox,

> Akzo Nobel’s Remeron, and two other

> GlaxoSmithKline drugs -- Wellbutrin and

> Zyban.

>

> The FDA has not reached a final decision about any

> link, but last month said

> it would update antidepressant labels to include

> information from various

> studies.

>

> It also called for a separate analysis from Columbia

> University that

> Mosholder has said echoes many of his concerns.

>

> A panel of outside experts convened by the FDA meets

> next week to discuss the

> new analysis and other information.

>

> The antidepressant controversy has prompted calls

> for better disclosure of

> clinical trials that yield unfavorable results.

> Manufacturers did not publicize

> studies that raised safety questions and that failed

> to show the effectiveness

> of most of the drugs in treating pediatric

> depression.

>

> To forestall future similar problems, major medical

> journals said this week

> they would not publish results from any clinical

> trials that are not registered

> in a national database.

>

> “The bottom line is that physicians and

> researchers who formulate treatment

> guidelines for patients must be able to trust the

> information that they use,â€

> Dr. Ronald Davis, an American Medical Association

> trustee, said at the hearing.

>

> Copyright 2004Â Reuters Limited. All rights

> reserved. Republication or

> redistribution of Reuters content is expressly

> prohibited without the prior written

> consent of Reuters.

>

> URL: http://www.msnbc.msn.com/id/5953983/

>