CIRCARE's Accomplishments

We have been singularly instrumental in bringing documented evidence of abuse in human subject research to public attention. We disseminate information to the public and have provided documented testimony about unethical psychosis-inducing experiments before the National Bioethics Advisory Commission [(NBAC, 1997-09-18 (1)], and before several Congressional committee hearings [April 1998 (2); April 1999 (3)].

This public testimony, and the testimony by individuals and families who have been victimized in human research studies, led to federal investigations by the Office of Protection from Research Risks (1998), resulting in the cessation of some of those experiments, and NBACs recommendations to add federal protections for decisionally impaired human subjects.

Among the experiments halted were:

1. Subjects with schizophrenia enrolled in medication withdrawal experiments at UCLA, which caused subjects to relapse (4).
2. Dubious fenfluramine experiments at the New York State Psychiatric Institute and Mount Sinai Medical Center that put minority children at risk without medical justification [NY Times, 1998-04-15 (5); 1999-06-12 (6)].
3. Ketamine experiments that misinformed patients about ketamines psychosis-inducing effect at the Maryland Psychiatric Research Center [NY Times, 1998-05 (7); The Washington Post, 1998-08-01: (8)].
4. With our assistance, a complaint was filed with OHRP describing concerns about the SATURN trial, an NIH-funded study that coerced student athletes into participating in mandatory drug testing. The SATURN trial was suspended in October 2002, and terminated in early 2004. (9)

The prize winning investigative series in the Boston Globe, Doing Harm: Research on the Mentally Ill, 1998-09-15-18 (10), was based largely on information provided by CIRCARE. The uncontested exposure of abuse in that series led Dr. Steve Hyman, then Director of the National Institute of Mental Health, to halt 30 of NIMH's own clinical studies, acknowledging that the experiments failed to meet medical ethical standards. (11) Our efforts have even begun to disturb some psychiatrists, as reflected in the 1999 editorial published in the American Journal of Psychiatry. (12)

In 2002, for the first time CIRCARE assisted patient advocates in Canada concerned about dubious clinical trials of EmpowerPlus conducted at the University of Utah and the University of Calgary; working together, complaints were filed with Health Canada and OHRP. In January 2002 Health Canada terminated the trials at Calgary, and in August 2002, OHRP issued a determination letter to the University of Utah regarding an investigator who conducted research despite prior IRB disapproval and without adequate informed consent. In 2004, criminal charges were filed against the Synergy Group of Canada Inc., distributor of EmpowerPlus drug products, for alleged violations of the Canadian Food and Drug Act. (13)

Notes

1. CIRCARE Testimony: Adil Shamoo Ph.D., CIRCARE Co-Founder. 1997-09-18. Available from http://bioethics.georgetown.edu/nbac/transcripts/sep97/human.pdf

2. CIRCARE Testimony: Adil Shamoo Ph.D., CIRCARE Co-Founder. 1998-04. Available from http://www.house.gov/reform/hearings/healthcare/fda498/shamoo.pdf

3. CIRCARE Testimony: Adil Shamoo Ph.D., CIRCARE Co-Founder. 1999-04-21. Available from http://www.house.gov/va/hearings/schedule106/apr99/4-21-99J/shamoo.htm

4. For the Sake of Science. Joy Horowitz. The Los Angeles Times. 1994-09-11.

5. Experiments on Children Are Reviewed. Philip J. Hilts. New York Times. 1998-04-15.
URL: http://query.nytimes.com/gst/fullpage.html?res=9C0DEEDB163CF936A25757C0A96E958260&sec=health&pagewanted=all

6. 2 Institutions Faulted for Tests on Children. Nina Bernstein. The New York Times. 1999-06-12.

7. Psychiatric Researchers Under Fire. Philip J. Hilts. The New York Times. 1998-05-19.
URL: http://query.nytimes.com/gst/fullpage.html?res=9F0DEFDC1639F93AA25756C0A96E958260&sec=health&pagewanted=print

8. Research Volunteers Unwittingly at Risk. Rick Weiss. The Washington Post. 1998-08-01.
URL: http://www.washingtonpost.com/wp-srv/national/science/ethical/ethical.htm

9. The SATURN Trial:

Oregon Health & Science University News Release. 2003-04-29. Available from http://www.ohsu.edu/news/2003/042903saturn.html

Oregon Health & Science University News Release. 2003-04-15. Available from http://www.ohsu.edu/news/2003/041503saturn.html

Borror KC. Office for Human Research Protections Determination Letter to Oregon Health & Science University. 2004-01-15. Available from http://www.hhs.gov/ohrp/detrm_letrs/YR04/jan04g.pdf

Borror KC. Office for Human Research Protections Determination Letter to Oregon Health & Science University. 2003-04-17. Available from http://www.hhs.gov/ohrp/detrm_letrs/YR03/apr03c.pdf

10. Doing Harm: Research on the Mentally Ill. Testing takes human toll. Robert Whitaker and Delores Kong. The Boston Globe. 1998-11-15.
URL: http://web.archive.org/web/19991008230951/http://boston.com/globe/nation/packages/doing_harm/day1.htm

Doing Harm: Research on the Mentally Ill. Debatable forms of consent. Delores Kong and staff. The Boston Globe. 1998-11-16.
URL: http://web.archive.org/web/20000916151238/boston.com/globe/nation/packages/doing_harm/day2.htm

Doing Harm: Research on the Mentally Ill. Lure of riches fuels testing. Robert Whitaker. The Boston Globe. 1998-11-17.
URL: http://web.archive.org/web/20000916151306/boston.com/globe/nation/packages/doing_harm/day3.htm

Doing Harm: Research on the Mentally Ill. Still no solution in the struggle on safeguards. Delores Kong. The Boston Globe. 1998-11-18.
URL: http://web.archive.org/web/20010613014648/boston.com/globe/nation/packages/doing_harm/

11. Marshall E. NIMH to Screen Studies for Science and Human Risks. Science. 1999; 283: 464-465.

12. Salzman C. Not All Psychiatric Research is Bad. American Journal of Psychiatry. 1999;156:987-988.

13. Clinical trials testing EmpowerPlus:

McNeilly PJ. Office for Human Research Protections Determination Letter to the University of Utah. 2002-08-19. Available from http://www.hhs.gov/ohrp/detrm_letrs/YR02/aug02e.pdf

Questions and Answers: Health Canada's Actions Against EmpowerPlus. June, 2003. Available from http://www.hc-sc.gc.ca/english/protection/warnings/2003/empowerplus.htm

Akoury M. Health Canada. Correspondence to Bonnie J. Kaplan, Ph.D. / Unsatisfactory Clinical Trials License Application for studies titled Nutraceutical Treatment of Mental Disorders in Adults: An RCT with Bipolar Disorder and Fibromyalgia Clinical Study. 2002-01-04. Available from http://www.circare.org/FOIA/hc_cta_20020104.pdf

Index of documents relating to psychiatric research testing EmpowerPlus on adults and children at the University of Utah and the University of Calgary. Available from http://www.circare.org/FOIA/ATIPindex.htm

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Last Updated: 2007-02-20

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