UCLA and NIH Involvement in Malariotherapy Research in Subjects with HIV/AIDS

On 2002-10-08 the UCLA Office for Protection of Research Subjects (UCLA OPRS) wrote to Professor John Fahey M.D. asking him to respond to allegations that he participated in research conducted by Xiao Ping Chen, M.D., in which Chinese subjects diagnosed with HIV/AIDS were deliberately infected with malaria, ostensibly to assess the efficacy of induced malaria to stimulate the immune system as a treatment for HIV/AIDS. The complaint received by UCLA further alleged that because Dr. Fahey had arranged for Xiao Ping Chen, M.D. to participate in the NIH Fogarty International Program, NIH funds were expended to support research that failed to comply with the Common Rule for the protection of human research subjects and moreover caused the institution to be engaged in research which lacked IRB review and approval.

Overall impression: Steve Peckman and the UCLA Office for Protection of Research Subjects did an outstanding job in their investigation of the complaint involving Dr. Fahey and did so under circumstances which some people might consider difficult. Readers are left to wonder what the NIH's Fogarty International Center knew about the use of its award.

Peckman S. UCLA Office for Protection of Research Subjects. Letter to John Fahey M.D. 2002-10-02. Available from http://www.circare.org/foia4/uclaoprs_fahey20021002.pdf. Accessed on 2006-03-04.

The allegation regarding Dr. Fahey incorporated the following documents by reference:

1. Malaria and AIDS Epidemics in Africa. The Heimlich Institute Foundation. 2004-02-05. Available from http://web.archive.org/web/20040206063245/www.heimlichinstitute.org/aidsafrica.html. Accessed on 2006-03-04.
2. John McDougall Interview with Henry Heimlich M.D. The McDougall Newsletter. July–August 1998. Available from http://web.archive.org/web/20000819051540/http://drmcdougall.com/Newsletter/july_aug1.html. Accessed on 2006-03-04.
3. The Heimlich Institute. Heimlich Institute Using Malariotherapy to Treat HIV/AIDS Infection. Caring World. Vol.1. No.1. Winter 1998. Available from http://www.heimlichinstitute.org/media/CaringWorldWinter98.pdf. Accessed on 2006-03-04.
4. The Heimlich Institute. Malariotherapy Research to Treat HIV/AIDS ($1.2 million). Caring World. Vol.1. No.3. Fall 1999. Available from http://www.heimlichinstitute.org/media/CaringWorldFall99.pdf. Accessed on 2006-03-04.
5. Heimlich H. Letter to Jane Henney, Commissioner, FDA. 2000-05-04. Available from http://www.bioethicswatch.org/foia/hh_fda_20000504.pdf. Accessed on 2006-03-04. (Note: the version in the complaint is redacted by FDA. This version, however, is not redacted and was obtained by CIRCARE among public documents in LS-0112061-MED. Wisconsin Medical Examining Board, In the Matter of the Disciplinary Proceedings Against Eleazar Kadile M.D.)
6. Chen XP, Heimlich HJ, Xiao B, Liu S, Lu Y, Yao J, Spletzer EG. Phase–1 Studies of Malariotherapy for HIV Infection. Chin Med Sci J. 1999 Dec;14(4):224-8. Available from http://www.bioethicswatch.org/foia/imt_cjms1999.pdf. Accessed on 2006-03-04.
7. Chen XP. et al. Impact of Acute Vivax Malaria on the Immune System of HIV-Positive Subjects. Poster No. 149. AIDS Vaccine 2001. 2001-09-06 to 08. Available from http://web.archive.org/web/20030721190418/http://63.84.172.40/Posters/149.1.a.pdf. Accessed on 2006-03-04.

In his initial response to the UCLA OPRS on 2002-10-17 Dr. Fahey denied the allegations. Dr. Fahey subsequently sent an addendum to this response on 2002-10-24 in which he noted that Dr. Chen's funding ended in 1999.

Fahey JL. Letter to UCLA Office for Protection of Research Subjects. 2002-10-17. Available from http://www.circare.org/foia4/fahey_uclaoprs20021017.pdf. Accessed on 2006-03-04.

Fahey JL. Letter to UCLA Office for Protection of Research Subjects. Addendum to letter of 2002-10-17. 2002-10-24. Available from http://www.circare.org/foia4/fahey_uclaoprs20021024.pdf. Accessed on 2006-03-04.

On 2002-11-22 the UCLA Daily Bruin published an article on Dr. Fahey's involvement in the Heimlich Institute's malariotherapy research:

Researchers' possible link to malariotherapy scrutinized. Edward Chiao & Jeyling Chou. The Daily Bruin Online. 2002-11-22. Available from http://www.dailybruin.ucla.edu/news/printable.asp?id=21891&date=11/22/2002. Accessed on 2006-03-04.

Dr. Fahey wrote to the UCLA OPRS again on 2002-11-26, considering the issues raised in the article, in order to determine the clarity of my earlier responses to your specific questions and whether relevant issues were addressed. In light of subsequent evidence, e.g., that Dr. Fahey received data from subjects in malariotherapy studies, provided reagents for lab tests which were part of malariotherapy research, and corresponded with Dr. Heimlich about Dr. Chen's ongoing malariotherapy research, it's difficult to accept Dr. Fahey's assertion that he provided training and limited funding only, and was not involved with malariotherapy research or the Heimlich Institute.

In point of fact, according to Dr. Fahey's letter of 1996-08-08 to Dr. Heimlich, Dr. Fahey sought Dr. Heimlich out following a 1996 presentation of preliminary data from malariotherapy research conducted by Dr. Chen in China, and did so for the explicit purpose of developing a means of helping your Chinese colleagues in carrying out their studies.

Fahey JL. Letter to Henry Heimlich M.D. 1996-08-08. Available from http://www.circare.org/foia4/fahey_heimlich19960808.pdf. Accessed on 2006-03-04.

Fahey JL. Letter to UCLA Office for Protection of Research Subjects. 2002-11-26. Available from http://www.circare.org/foia4/fahey_uclaoprs20021126.pdf. Accessed on 2006-03-04.

The complaint received by the UCLA OPRS also alleged that Dr. Henry Heimlich was using UCLA's name to promote malariotherapy for HIV/AIDS. On 2002-11-05 Dr. Fahey assured UCLA Senior Associate Dean for Academic Affairs Michael Friedman, M.D. that he had not been involved with Dr. Heimlich and it would be appropriate for the institution to request that Dr. Heimlich cease and desist from the use of UCLA's name.

Fahey JL. Letter to Michael Friedman M.D., Senior Associate Dean for Academic Affairs, David Geffen School of Medicine at UCLA. 2002-11-05. Available from http://www.circare.org/foia4/fahey_friedman20021105.pdf. Accessed on 2006-03-04.

On 2002-12-02 ostensibly acting on Dr. Fahey's assurance that he was not involved with malariotherapy research on subjects diagnosed with HIV/AIDS sponsored or conducted by the Heimlich Institute, UCLA Campus Counsel Patricia Jasper wrote to Dr. Heimlich requesting him to stop using UCLA's name.

Jasper P. Letter to Henry Heimlich M.D. 2002-12-02. Available from http://www.circare.org/foia4/ucla_heimlich20021202.pdf. Accessed on 2006-03-04.

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To everyone's surprise, on 2002-12-16 Dr. Heimlich replied and enclosed correspondence to support the contention that UCLA professor Dr. John Fahey was indeed involved with malariotherapy research on subjects diagnosed with HIV/AIDS sponsored or conducted by the Heimlich Institute and conducted by Xiao Ping Chen, M.D. in China.

Heimlich H. Letter to Patricia Jasper. 2002-12-16. Available from http://www.circare.org/foia4/heimlich_ucla20021216.pdf. Accessed on 2006-03-04.

Enclosures, Henry Heimlich, M.D. to Patricia Jasper, Campus Counsel, UCLA. 2002-12-16:

1. Fahey JL. Letter to Henry Heimlich M.D. 1996-08-08. Available from http://www.circare.org/foia4/fahey_heimlich19960808.pdf. Accessed on 2006-03-04.
2. Fahey JL. Letter to Henry Heimlich M.D. 1997-08-06. Available from http://www.circare.org/foia4/fahey_heimlich19970806.pdf. Accessed on 2006-03-04.
3. Najera E. Letter to Xiao Ping Chen M.D. 1996-12-16. Available from http://www.circare.org/foia4/najera_chen19961216.pdf. Accessed on 2006-03-04.
4. Email correspondence. Heimlich H, Chen XP, Fahey JL. November 1997 – February 2001. Available from http://www.circare.org/foia4/uclafoia1.pdf. Accessed on 2006-03-04.

Dr. Heimlich's letter to Patricia Jasper of 2002-12-16 also asked that subsequent correspondence on this matter addressed to his attorney Joseph Dehner, Esq.

Jasper P. Letter to Joseph Dehner, Esq. 2003-02-26. Available from http://www.circare.org/foia4/ucla_dehner20030226.pdf. Accessed on 2006-03-04.

Dehner J. Letter to Patricia Jasper. 2003-02-27. Available from http://www.circare.org/foia4/dehner_ucla20030227.pdf. Accessed on 2006-03-04.

In the meanwhile the ULCA OPRS concluded that Dr. Fahey did not appear to have been engaged in human subject research as alleged in the complaint but nevertheless requested clarification of whether or not Dr. Chen had obtained IRB approval for research use of subject blood samples obtained during malariotherapy research and brought to UCLA, and what Dr. Fahey understood about Dr. Chen's activities and intentions.

Figlin RA. UCLA Office for Protection of Research Subjects. Letter to John Fahey M.D. 2002-12-10. Available from http://www.circare.org/foia4/uclaoprs_fahey20021210.pdf. Accessed on 2006-03-04.

Fahey JL. Letter to UCLA Office for Protection of Research Subjects. 2002-12-30. Available from http://www.circare.org/foia4/fahey_uclaoprs20021230.pdf. Accessed on 2006-03-04.

At some point after the letter of 2002-12-10 to Dr. Fahey, the correspondence enclosed with Dr. Heimlich's letter to Campus Counsel Patricia Jasper (above) made its way to the UCLA OPRS. No doubt they were taken aback having made their determination based upon Dr. Fahey's assurance that he was not involved with Dr. Heimlich's malariotherapy research conducted by Xiao Ping Chen, M.D. in China.

Figlin RA. UCLA Office for Protection of Research Subjects. Letter to John Fahey M.D. 2003-02-14. Available from http://www.circare.org/foia4/uclaoprs_fahey20030214.pdf. Accessed on 2006-03-04.

UCLA Office for Protection of Research Subjects. Staff Evaluation: malariotherapy research allegations. 2003-03-23. Available from http://www.circare.org/foia4/uclaoprs_faheyeval20030323.pdf. Accessed on 2006-03-04. (Note: We assume this evaluation refers to information provided by Dr. Fahey in response to UCLA OPRS' request of 2003-02-14 and withheld from disclosure under FOIA.)

On 2003-03-30 UCLA OPRS notified Dr. Fahey of their determination. UCLA concluded that Dr. Chen brought subject samples to UCLA which were coded with indirect links to personal identifiers, and this met the definition of engagement in human subject research, and as such required review and approval by the UCLA IRB. They also determined it was Dr. Fahey's responsibility to ensure IRB approval as required as part of his supervision of Dr. Chen, his trainee participating in the Fogarty International Program.

Figlin RA. UCLA Office for Protection of Research Subjects. Letter to John Fahey M.D. 2003-03-30. Available from http://www.circare.org/foia4/uclaoprs_fahey20030330.pdf. Accessed on 2006-03-04.

In response to the final determination of the UCLA OPRS Dr. Fahey wrote back asking how he could be expected to know that Dr. Chen's research at UCLA in 1997 required IRB approval, noting that in the determination, they cited a 1999 policy.

Fahey JL. Letter to UCLA Office for Protection of Research Subjects. 2003-04-29. Available from http://www.circare.org/foia4/fahey_uclaoprs20030429.pdf. Accessed on 2006-03-04.

On 2003-06-10 UCLA OPRS replied, explaining Dr. Fahey was mistaken because the policy had been in effect since 1996.

Figlin RA. UCLA Office for Protection of Research Subjects. Letter to John Fahey M.D. 2003-06-10. Available from http://www.circare.org/foia4/uclaoprs_fahey20030610.pdf. Accessed on 2006-03-04.

Dr. Chen's Post Training AIDS–Related Activity following training through the Fogarty International Program is listed as Phase I study of malariotherapy for HIV/AIDS. This begs the question of what Dr. Chen was doing in the research conducted prior to and during his training, from which he sent Dr. Fahey subjects' data, and for which he requested reagents to conduct lab tests.

UCLA Table 4: Cumulative Listing of Individuals Receiving Postdoctoral Training. 1997-09-30. Available from http://www.circare.org/foia4/ucla_table4.pdf. Accessed on 2006-03-04.

UCLA released the bibliography of publications by Xiao Ping Chen, M.D. while he was a participant in the AIDS International Research and Training Program (AIRTP), sponsored by the NIH Fogarty International Program and supervised at UCLA by Dr. Fahey. It may strike readers as odd that the publications exclude Dr. Chen's 1999 paper on malariotherapy which thanks Dr. Fahey for financial and professional support. (Chen XP, Heimlich HJ, Xiao B, Liu S, Lu Y, Yao J, Spletzer EG. Phase–1 Studies of Malariotherapy for HIV Infection. Chin Med Sci J. 1999 Dec;14(4):224-8. p.228. Available from http://www.bioethicswatch.org/foia/imt_cjms1999.pdf. Accessed on 2006-03-04.)

UCLA Bibliography of Publications by Xiao Ping Chen M.D. Undated. Available from http://www.circare.org/foia4/ucla_bibliographyofpublications.pdf. Accessed on 2006-03-04.

Borror KC. Office for Human Research Protections. Letter to UCLA. 2003-03-19. Available from http://www.circare.org/foia4/ohrp_ucla20030319.pdf. Accessed on 2006-03-04.

Brookshire JL. UCLA Office for Protection of Research Subjects. Letter to the Office for Human Research Protections. 2003-06-24. Available from http://www.circare.org/foia4/ucla_ohrp20030624.pdf. Accessed on 2006-03-04.

UCLA. Press Release (revisions): Medical Institutional Review Board Decision in Fahey case. 2003-04-02. Available from http://www.circare.org/foia4/uclapr_revisions20030402.pdf. Accessed on 2006-03-04.

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Last Updated by EW on: 2006-03-04

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