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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


 

Ms. Vera Hassner-Sharav
Alliance for Human Research Protection
142 West End Ave, 28 P
New York, New York 10023

November 15, 2002

Dear Ms. Hassner-Sharav,

As you know, our family and the Lamadrid family are involved in litigation involving an NIMH-funded schizophrenia relapse experiment conducted by UCLA researchers.

Our trial is scheduled in the Los Angeles Superior Court for January, 2003.

NIMH sponsored the schizophrenia research with millions of dollars and has demonstrated a direct and substantial interest over time in protecting the interests of the researchers, though NIH policy prohibits an NIH employee from testifying in a case in which a government entity (NIMH) has a direct interest. NIMH has a vested interest.

We were recently notified by defendants’ counsel that Daniel R. Weinberger, M.D., Chief of NIMH’s Clinical Brain Disorders Branch, has been engaged to serve as an expert witness on behalf of the UCLA defendants. Dr.Weinberger is scheduled to be deposed on December 20, 2002.

NIMH, the sponsor of the research, approved Dr. Weinberger’s request to testify for UCLA, disregarding applicable NIH ethical policies and procedures. For example:

1) Controversial Case

NIH policy prohibits an NIH employee from testifying in a controversial case. Substantial evidence demonstrates that this case is highly controversial and has been controversial since the original complaint was filed with OPRR in April, 1991.

Reports on this case have appeared in the United Press & Associated Press, a New York Times article and editorial, an editorial in the Los Angeles Times, a report in Time Magazine, the Washington Post, CNN’s Larry King Live, ABC’s 20/20, ABC Evening News, etc. Several U. S. Congressional Committee hearings have discussed this case. In addition, there have been numerous discussions in medical, legal and academic journals about the controversial nature of this case.

2) Continuing NIMH Ethical Violations

Releasing Unpublished Information

Payment for Testimony About Official NIMH Duties

NIMH permitted another NIMH administrator (in addition to Dr. Weinberger) to testify as an expert in this case and the following ethical violations of NIH ethical policies took place:

a) While NIH policy prohibits an NIMH employee from revealing unpublished information in an outside activity, a NIMH administrator testified on behalf of UCLA and provided testimony for UCLA that included unpublished information.

b) While NIH policy prohibits an NIMH employee from receiving compensation for outside activities that relate to official duties and responsibilities, a NIMH administrator testified about his official NIMH duties and was paid $13, 090.20 for consulting and for his 83-minute deposition.

3)   Direct Interest in Case Demonstrated by NIMH

a) NIMH supported UCLA’s action to block access to patient records (1991) in violation of California state law, until a California health agency ruled that the records must be provided to the patient. (The records had been withheld by UCLA for 2 ¸ years).

b) Though OPRR determined (1994) that legally valid informed consent had not been obtained by UCLA for over a ten-year period, the Director of NIMH at that time (Fred Goodwin, M.D.) defended UCLA’s informed consent process as appropriate.

c) The NIMH administrator who served as an expert for UCLA consulted with OPRR (1992) during its investigation of UCLA but when he was deposed by plaintiffs’ attorney, the administrator was unable to recall his previous consulting with OPRR.

We believe that the approval recently granted to Dr. Weinberger, a senior NIMH administrator, to testify as an expert against us in our trial that challenges NIMH-sponsored research, was improperly granted and should be promptly rescinded.

(A list of relevant Exhibits is attached.)

The Aller and Lamadrid families would appreciate your assistance in directing this matter to the appropriate persons at NIH and related government entities.

                                                                        Sincerely,
                                                                        Bob Aller