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THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Tel. 212-595-8974             142 West End Ave Suite 28P                     FAX: 212-595-9086
New York, NY 10023
www.ahrp.org

December 5, 2002
Mr. Edward Swindell
Acting Associate General Counsel for Ethics
Office of General Counsel, Ethics Division
Department of Health and Human Services
200 Independence Ave. SW
Room 700 E, HHH Building
Washington, DC 20201

Ph:  (202) 690-7258
Fx:  (202) 690-5452

Dear Mr. Swindell,

I am writing to you requesting an Ethics Division review of violations of NIH ethical policies regulating outside activities for NIH employees who testify as experts.

A lawsuit charging unethical research conduct in a NIMH sponsored study expected to go to trial in the Los Angeles Superior Court in January, 2003.

Attached is a complaint from two plaintiff families who have requested assistance from the Alliance for Human Research Protection. We hereby request the Ethics Division to review this matter and also to refer this matter to the Inspector General because the fact pattern appears to us to reflect systemic conflict of interest violations. What is more, we further contend that the failure of the UCLA researchers to implement the blinded study, as called for in the research protocol, constituted a breach of contract between the NIMH and UCLA that effectively precluded obtaining valid research findings. For this breach, we urge the Office of the Inspector General to take action to recover the tax-payer funds that were expended.

This litigation involves NIMH-funded schizophrenia research that has been widely criticized in the lay press and academic journals. One of the research subjects, Tony Lamadrid, after suffering a severe psychotic relapse, committed suicide in a later phase of the research, for which no protocol existed, but during which data continued to be collected (according to the findings of the (then) Office of Protection from Research Risks (now) Office of Human Research Protections). The other subject, Greg Aller, also suffered a severe psychotic relapse.

This NIMH-funded study was described in Congressional testimony by the (then) Director of OPRR, Gary Ellis, before the House Veterans Administration sub-committee, April 26, 1999:

At UCLA, we identified through the mid-1990s a culture of noncompliance with federal human subject regulations.

OPPR investigated this case and found that the informed consents over a ten-year period had failed to meet the requirements of applicable federal regulations (OPRR Report, May, 1994).

Throughout the period when this experiment was being investigated by state and federal agencies, discussed by the National Bioethics Advisory Commission, and in various Congressional hearings, NIMH administrators actively sought to protect and shield the researchers from accountability. Since NIMH had approved and funded the research a real conflict of interest exists.

The Alliance for Human Research Protection urges a review by your office and an ethics investigation by the Inspector General.  We believe that supporting documentation will demonstrate that NIMH administrators have utterly disregarded applicable ethical guidelines when they attempted to protect researchers with whom they have ongoing relationships.

Since NIMH administrator, Daniel Weinberger, M.D., is scheduled to be deposed in the coming weeks – we believe that an expedited review by your office and the Inspector General would be appropriate.

Please do not hesitate to contact us for any additional information that you may require.

Sincerely,

Vera Hassner Sharav
President
The Alliance for Human Research Protection

Cc: NIH ethics counselors
       Elias Zerhouni, MD., Director, NIH
       Richard Nakamura, MD, Director NIMH
       Mark McLellan, MD. Commissioner, FDA
       Janet Rhenquist, Esq. Inspector General, DHHS