Cong. Hearing Disclosure Pediatric SSRI Trials

[Guest guest]

> JustSayNo

> Thu, 08 Jul 2004 02:53:05 -0000

> [sSRI-Research] Cong Hearing Re: Disclosure

> Pediatric SSRI Trials

>

>

> ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

> Promoting openness and full disclosure

> http://www.ahrp.org

>

> FYI

>

> A hearing has been tentatively set for July 20th by

> the House

> subcommittee on oversight and investigations,

> chaired by Congressman

> James Greenwood. The hearing will address issues of

> disclosure

> involving pediatric antidepressant drug trials--or

> more accurately,

> non-disclosure of adverse findings. The unpublished

> evidence comes

> from concealed company data.

>

> Questions, will no doubt be raised about the

> responsibility of drug

> manufacturers (ie., trial sponsors), of those who

> conducted the

> trials, and prominent psychiatrists whose names

> appear in published

> reports that fail to disclose negative

> findings--neither the drugs'

> failure to demonstrate a benefit nor the most severe

> adverse effects.

>

> Recently, concealed findings have been brought to

> public attention,

> such as, evidence of severe drug withdrawal

> symptoms, evidence of

> drug-induced agitation/ aggression / hostility /

> mania/ and even a

> two-fold suicidal behavior in children /adolescents

> testing an SSRI

> antidepressant compared to those given a placebo.

>

> As disturbing as company suppression of vital

> information about drug

> safety and benefit is, the uncovering of suppression

> by FDA officials-

> -who are paid to protect the public health--is a

> stunning betrayal of

> public trust.

>

> On February 1, 2004, Rob Waters of the San Francisco

> Chronicle

> revealed that senior FDA officials were suppressing

> the agency's own

> medical expert, Dr. Andrew Mosholder, a child

> psychiatrist, from

> presenting his analysis of the unpublished company

> data and

> recommendations at a public FDA advisory committee

> meeting ( February

> 2, 2004) that had convened for that purpose.

>

> The advisory committee heard compelling testimony

> from more than 50

> families whose children had suffered because the

> risks have been

> concealed from physicians and the public. Their

> testimonies

> corroborated the data analyzed by Dr. Mosholder. His

> analysis and

> recommendations were in harmony with those of the

> British Medicines

> authority. Although the advisory committee did not

> hear Dr.

> Mosholder's recommendations, they reached the same

> conclusion, urging

> the FDA to issue " Black Box " warning labels.

>

> As noted, the suppression of Dr. Mosholder's report

> was first

> revealed by the San Francisco Chronicle, Feb. 1--the

> day before the

> advisory committee meeting. I personally informed

> the committee of

> the report and its suppression in my comments. Not

> a single reporter

> present at the meeting saw fit to enquire of FDA

> officials why Dr.

> Mosholder was prevented from presenting his

> findings. Two months

> passed before someone in the major media understand

> the significance

> of such suppression of vital information. On March

> 30, Sharyl

> Attkisson of CBS evening News reported the issue.

> See:

>

http://www.cbsnews.com/stories/2004/03/30/eveningnews/main609491.shtml

>

>

>

> Contact: Vera Hassner Sharav

> Tel: 212-595-8974

> e-mail: veracare

>

>

>

> http://news.ft.com/servlet/ContentServer?

> pagename=FT.com/StoryFT/FullStory & c

> =StoryFT & cid=1087373496224

>

> Financial Times

>

> Anti-depressant hearings set for this month By

> Christopher Bowe in

> New York

> Published: July 5 2004 18:41 |

>

> A House of Representatives subcommittee is planning

> to hold hearings

> in the first half of this month to address questions

> on the potential

> for anti-depressants to cause suicidal behaviour in

> children.

>

> The Oversight and Investigation subcommittee, led by

> James Greenwood,

> the Pennsylvania Republican on the House Energy and

> Commerce

> committee, intends to gather information on the use

> of anti-

> depressants by children, potential safety

> consequences and US

> regulatory research into safety issues.

>

> Also, the subcommittee will gather information on

> the circumstances

> of an internal recommendation made by a Food and

> Drug Administration

> researcher.

> Considerable interest has focused on allegations

> that FDA senior

> officials barred Dr Andrew Mosholder, an FDA

> scientist, from

> releasing his recommendation that anti-depressants

> increased the risk

> of suicidal tendencies in young people. He also

> recommended immediate

> further regulatory warnings about their use by

> minors.

>

> Dr Mosholder found that the drugs, particularly

> selective serotonin

> reuptake inhibitors (SSRIs), continue to pose

> questions about risk of

> side- effects, especially in children.

>

> He also raised questions about the regulators'

> review of trial data

> and safety warnings from such data.

>

> In May, Columbia University's Division of Child and

> Adolescent

> Psychiatry released a study showing parents' worries

> about depression

> medication.

> About 68 per cent of parents feared that

> anti-depressants were over-

> prescribed to young people, according to the study

> conducted by the

> Carmel Hill Center for Early Diagnosis and Treatment

> at the

> university.

>

> However, while 31 per cent of parents considered

> anti-depressants

> harmful to adolescents, 69 per cent thought the

> drugs were not

> harmful or did not know. More than half the parents

> responded that

> teenagers received treatment for depression without

> being clinically

> depressed.

>

> Prior to a February regulatory advisory committee

> meeting to weigh

> the risks of anti-depressants and suicide, Dr

> Mosholder completed a

> review of clinical trials. He concluded that

> anti-depressants could

> be linked to increased suicidal tendencies in

> children and

> recommended regulators act.

>

> But he was prevented from presenting that view to

> the advisory panel.

> Senator Charles Grassley, Republican from Iowa,

> wrote to regulators

> that Dr Mosholder was given a " script to read " .

>

> The FDA began an investigation aimed at identifying

> the leak of the

> Mosholder report, according to a congressional

> source.

>

>