FDA Research Grant for SSRI's

From the Alliance for Human Research Protection

FYI

A fifteen year struggle by critics of the drug-centered treatment paradigm in psychiatry is being indirectly validated both by the FDA and the National Institute of Mental Health who are addressing the issue of SSRI and suicide publicly.

The FDA is planning a year long study of the evidence of SSRI antidepressants and the risk of suicide in adults. The first advisory committee hearing of the Drug Safety and Risk Management Advisory Committee is scheduled for December 8-9. See here

The following research grant being offered by the National Institute of Mental Health:

Program Number: 85476
Title: RFA-MH-06-001-- Antidepressant Treatment and Suicidality
Sponsor: National Institute of Mental Health/NIH/DHHS

SYNOPSIS:
The sponsor offers support for research to study the relationship between use of antidepressant medications, especially the selective serotonin reuptake inhibitors (SSRIs), and suicidality (including suicidal ideation, suicidal attempts, and suicide deaths).

This RFA is designed to encourage innovative, multi-disciplinary, multi-method efforts to explore the pharmacological, psychological and social mechanisms that potentially put some individuals at greater risk for suicidality when prescribed antidepressants.

This RFA will use the NIH research project grant (R01), Exploratory/ Developmental grant (R21) and R34 award mechanisms.

Deadline(s): 11/21/2005 12/20/2005
Established Date: 09/28/2005
Follow-Up Date: 01/01/2006
Review Date: 09/28/2005

Contact: Jane Pearson, Ph.D.

Address: Division of Services and Intervention Research
6001 Executive Blvd.
Room 7160, MSC 9635
Bethesda, MD 20892-9635
U.S.A.

E-mail: jp36u@nih.gov

Program Website
Tel: 3014-443-3598
Deadline Ind: Receipt
Deadline Open: No

*See Restrictions for further information.

DEADLINE NOTE
The deadline for receipt of optional letters of intent is November 21,
2005. The deadline for receipt of full applications is December 20, 2005.
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AHRP believes that it is essential that research grants under this NIMH RFA NOT be awarded to any of the psychiatrists who helped perpetuate the lie that these drugs were "safe and effective" and led the fight against warnings about the drugs implication in increasing the risk of suicide, violence, and severe withdrawal symptoms.

In particular, psychiatrists associated with the American College of Neuropsychopharmacology (ACNP) or the American Psychiatric Association (APA), or the American Academy of Child and Adolescent Psychiatry (AACAP) should be disqualified from the NIMH grant examining the link beteween antidepressants and suicide--as should employees of PhRMA, the Pharmaceutical trade lobbying association.

The ACNP, APA, and AACAP have been instrumental in misleading physicians and the public by vehemently denying the scientific evidence, rejecting the analyses by several independent expert panels who determined that SSRIs posed an increased suicide risk for children and adolescents compared to those given a sugar pill. Even as the FDA now estimates that the risk of suicidality in children prescribed an SSRI to be as high as 1 in 50.

Two weeks prior to FDA's advisory committee hearing (February 2004) the ACNP issued a "preliminary" Task Force report by the leading US psychiatric establishment at a highly publicized press briefing orchestrated by a public relations agency (GYMR) which also disseminated the report. ACNP's discredited report and its sweeping unsubstantiated, false assertions about the safety of SSRIs for children--"No significant Increase in Suicidal Behaviour in Clinical Trials of Youth"--was was aggessively promoted by GYMR, in an effort to divert public attention from the evidence. ACNP's bald claim was made on the basis of partial evidence--excluding substantial unpublished data kept under company seal.

Following the FDA advisory requiring Black Box warnings on all SSRI drug labels (October 1004) the APA defiantly issued a news release stating:

"The American Psychatric Association believes that antidepressants save lives."

No such claim may be made by any SSRI drug manufacturer because there is absolutely no evidence to support it.

Another avenue being used to perpetuate the lies is to disseminate misinformtion and false claims about SSRIs through proxies such as a hastily formed website, ParentsMedGuide.org, whose long list of sponsoring organizations are closely linked to pharmaceutical companies.

Posted on this website are purpoted "Guides " prepared by the APA and the AACAP. while it is claimed that the purpose of the guides is "to help patients, families, and physicians make informed decisions about obtaining and administering the most appropriate care for a child with depression" the claims made are patently false:

" There is no evidence that antidepressants increase the risk of suicide." See here

FDA is working closely with the manufacturers of all marketed antidepressants to fully evaluate the risk of suicidality in adults treated with these drugs. The FDA has asked these manufacturers to identify all placebo-controlled trials conducted in adults in their development programs for their antidepressant products, regardless of the indication studied, and to provide information from these trials to FDA.

Manufacturers are being asked to use a similar approach to assembling this information as was used in evaluating the risk of suicidality in placebo-controlled trials in pediatric patients treated with antidepressant medications. The method used to analyze the data for risk of suicidality in children using antidepressant medications is described in more detail at the following web page link

A similar approach will be used for adults.

FDA’s comprehensive review will involve many hundreds of individual clinical trials and many thousands of adult patients. It is expected that this review will require a year or more to complete because of the large number of trials and the thousands of adverse events that must be checked for possible evidence of suicidality. The FDA will make the results of its review available to the public once its analyses are complete, and will update this advisory in the meantime if more definitive information becomes available.

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