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What's Wrong With This Research
Clinical Trial Documents Regulatory Correspondence
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Malariotherapy Research Publications Research on Malaria and HIV
Credibility FOIA: UCLA, NIH and John Fahey, M.D. Varia
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In 2004 The Heimlich Institute hired Victoria Wells Wulsin, M.D. to write a report that included a literature review of malariotherapy and a business plan for additional research. Dr. Wulsin released her report, to which she added an explanatory
Executive Summary, in the fall of 2006 following media inquiries during her campaign for congress. The report included data from an uncontrolled trial of malariotherapy in subjects with HIV/AIDS conducted in East Africa by an unnamed American sponsor.
Wulsin, VW. Immunotherapy and Beyond. December, 2004. Accessed on 2006-12-08 at: http://www.quackwatch.org/06ResearchProjects/wulsin_heimlich.pdf
Dr. Heimlich submitted this protocol to test induced malaria in Chinese subjects diagnosed with HIV/AIDS to the Great Lakes College of Clinical Medicine Institutional Review Board (GLCCM IRB) for review and approval in the spring of 1994. Neither unresolved ethical issues nor lack of jurisdiction over research conducted in China prevented the GLCCM IRB from approving Dr. Heimlich's research. Experts from the Food and Drug Administration, the Centers for Disease Control, and expert researchers at academic institutions, however, judged it be seriously flawed and unethical, as described below in the section titled
Expert Review & Critique of Malariotherapy Research Proposed by the Heimlich Institute. Six years later, following inspection of the GLCCM IRB, FDA suspended the IRB's authority to review and approve studies subject to FDA regulation when the agency concluded that the
IRB appears to lack the expertise or experience to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. FDA's evaluation of the GLCCM IRB is provided in the section titled: What's Wrong With This Research
Protocol: Induced Malaria Therapy (IMT) for HIV/AIDS. Heimich H. and The Heimlich Institute Foundation Inc. 1993-09-01: http://www.circare.org/foia2/malarioth_protocol.pdf
We are at a loss to explain why Dr. Wilbert Jordan M.D. is listed as a co-investigator with Dr. Heimlich in the protocol.
This is the consent form submitted by Dr. Heimlich for his malariotherapy study in China:
Consent Form: Induced Malaria as Therapy for HIV Infection. Heimich H. and The Heimlich Institute Foundation Inc. 1993-09-01: http://www.circare.org/foia2/imtconsentform_19931029.pdf
FDA judged the consent form to be deficient in a number of ways. Notice the enormously long waiver in the consent form purporting to compel research subjects and their survivors to give up their rights to sue for damages should they be harmed or killed (p. 3). Why shouldn't Dr. Heimlich and the Great Lakes College of Clinical Medicine IRB comply with federal regulations for informed consent? The FDA Clinical Investigator Information Sheets explicitly reminds investigators that:
… consent documents must not waive or appear to waive the rights of the subject or release or appear to release those conducting the study from liability for negligence. (1)
Dr. Heimlich and the Heimlich Institute Foundation used this proposal to raise money to conduct malariotherapy research on subjects diagnosed with HIV/AIDS. The proposal outraged a number of experts and federal officials.
IMT: A Potential Cure For AIDS A Proposal For Funding by The Heimlich Institute Foundation Inc. 1993: http://www.circare.org/foia2/hh_imt_proposal.pdf
Outrage at Dr. Heimlich's malariotherapy proposal motivated Dr. Paul K. Bronston, M.D. to circulate this petition in response: (2)
Petition to U.S. Federal Agencies, Public Citizen, and The National Council Against Health Fraud to investigate issues raised byIMT: A Potential Cure For AIDS,funding proposal circulated by the Heimlich Institute. 1993-05-07: http://www.circare.org/foia2/imtpetition.pdf
The physicians and scientists who signed the petition also provided expert appraisals of Dr. Heimlich's proposed research testing malariotherapy in people diagnosed with HIV/AIDS; their appraisals are not favorable — to put it mildly.
del Rio C. Letter to Paul Bronston, M.D. 1993-03-12: http://www.circare.org/foia2/delrio_bronston_19930312.pdf
del Rio C. Letter to Lisa Wilson, The Pasadena Star-Tribune. 1993-05-04: http://www.circare.org/foia2/delrio_wilson_19930504.pdf
del Rio C. Letter to Paul Bronston, M.D. 1993-11-16: http://www.circare.org/foia2/delrio_bronston_19941116.pdf
Sonnenberg FA. Letter to Paul Bronston, M.D. 1993-03-10: http://www.circare.org/foia2/sonnenberg_bronston_19930310.pdf
Sigal LH. Letter to Paul Bronston, M.D. 1993-03-15: http://www.circare.org/foia2/sigel_bronston_19930315.pdf
Mitsuyasu RT. Letter to Paul Bronston, M.D. 1993-03-15: http://www.circare.org/foia2/mitsuyasu_bronston_19930315.pdf
Dominguez EA. Letter to Paul Bronston, M.D. 1993-03-10: http://www.circare.org/foia2/dominguez_bronston_19930310.pdf
Oliver A. Letter to Paul Bronston, M.D. 1993-03-16: http://www.circare.org/foia2/oliver_bronston_19930316.pdf
Lanzer M. Letter to Paul Bronston, M.D. 1993-03-15: http://www.circare.org/foia2/lanzer_bronston_19930315.pdf
U.S. Centers for Disease Control (CDC) RE: Induced Malaria Infection for the Treatment of HIV/AIDS. 1993-04-29: http://www.bioethicswatch.org/foia/cdc_hh_19930429.pdf
Dr. Heimlich's experiment testing malariotherapy on people diagosed with HIV/AIDS in Guangzhou, China was approved by the Great Lakes College of Clinical Medicine Institutional Review Board (IRB) in the spring of 1994; this letter was sent to Dr. Heimlich by the IRB:
Chappell LT. Letter to Henry Heimlich M.D. re: IRB approval for induced malaria trial. 1994-05-27. Avaiable from http://www.circare.org/foia2/glccm_hh19940527.pdf
In 1999 FDA suspended the IRB's authority to approve new studies or enroll new research subjects in clinical trials testing FDA-regulated products (e.g., drugs and devices) because the IRB failed to protect the rights and welfare of research subjects:
Masiello S. FDA Warning Letter to Great Lakes College of Clinical Medicine Institutional Review Board. 2000-03-09: http://www.circare.org/foia2/fda_glccm20000309.pdf
The FDA restriction on the Great Lakes College of Clinical Medicine IRB only applied to research with drugs and devices subject to FDA regulation. In this letter Dr. Heimlich describes the status of his clinical trials and the applicability of the FDA restriction to his research:
Heimlich H. Letter to L. Terry Chappell M.D. re: FDA restrictions on IRB and status of clinical trial titledHeimlich Maneuver for Asthma.2000-04-25: http://www.bioethicswatch.org/foia/hh_ltc_20000425.pdf
The FDA Warning Letter to the IRB described extensive violations of federal regulations for the protection of human research subjects in the approval of Dr. Heimlich's clinical trial of malariotherapy for HIV/AIDS, and described at length the ways in which the informed consent was deficient, and pointed out that a) the IRB lacked jurisdiction to approve research in China, and b) it was inappropriate for Dr. Heimlich to submit his malariotherapy research to the IRB in the first place. FDA's 14 page laundry list of violations and objectionable actions made the IRB appear inept and corrupt, and arguably extended to research approved by the IRB. Dr. Heimlich was apparently embarrassed and incensed at the extensive critique of his malariotherapy study in the FDA Warning Letter to the IRB, and in consequence wrote to the Commissioner of FDA. On 2000-06-08 FDA's Stephen Masiello replied on behalf of Commissioner Henney rejecting Dr. Heimlich's demands.
Heimlich H. Letter to Jane Henney, M.D., Commissioner, FDA. 2000-05-04: http://www.circare.org/foia2/hh_fda20000504.pdf
Masiello S. Letter to Henry Heimlich, M.D. 2000-06-08: http://www.circare.org/foia2/fda_hh20000608.pdf
Despite widespread condemnation of Dr. Heimlich's malariotherapy research, and despite FDA's lengthy enumeration of violations of federal regulations by the Great Lakes Association of Clinical Medicine IRB in their inappropriate approval of the malariotherapy study, following the Cincinnati Enquirer's first article in March 2003, L. Terry Chappell, M.D., secretary of the GLCCM IRB, nonetheless wrote the Enquirer in support of Dr. Heimlich and the malariotherapy study approved by the IRB:
Dr. Henry Heimlich should be applauded for his research on treating AIDS with malariotherapy. The type of malaria used was easily curable with medications, and indeed there were no serious complications reported in his research project. The research was carried out according to the scientific guidelines.
Medications used to treat AIDS are not highly effective, can be toxic and are prohibitively expensive. Resistance to these medications is developing.
Malariotherapy is much cheaper than conventional drugs for AIDS. Health officials from several African counties have expressed considerable interest in Heimlich's pilot project. The therapy has the potential to be a major force against one of our greatest disease challenges. (3)
Contrary to Dr. Chappell's assertion that
no serious complications were reported in his research project, two research subjects died. On any account, death qualifies as a serious complication. (4)
You have to wonder what Dr. Chappell thinks
scientific guidelines are. The trial protocol had no bibliography, so he and his fellow IRB members had no way in which to judge the scientific merit of the study they approved. IRB members didn't know the name of the principal investigator conducting the study in China — it's difficult to understand how they could evaluate the way in which the study was to be carried out if they didn't know who carried it out. As part of their obligation to research subjects in the review of proposed research protocols, IRB members would need to evaluate the credentials of the investigators and the resources and policies of the institution.
Additional correspondence between FDA and the Great Lakes College of Clinical Medicine IRB, FDA Form 483s, criminal indictments, and administrative actions against IRB members and clinical investigators approved by the IRB are available at: http://www.circare.org/foia2/docs.htm
Dr. Heimlich previously conducted experiments in which research subjects with cancer and Lyme disease were infected with malaria, and to which the US Centers for Disease Control objected. The CDC memos and correspondence between Dr. Heimlich and the Centers for Disease Control are available at: http://www.circare.org/foia2/hhdocs.htm
Chen XP, Xiao B, Shi W, Xu H, Gao K, Rao J, Zhang Z. Impact of acute vivax malaria on the immune system and viral load of HIV-positive subjects. Chin Med J. 2003;116(12):1810-1820. Accessed on 2006-05-18 at: http://www.cmj.org/Periodical/PDF/2003/2003121810.pdf
Chen XP, Xiao B, Xu H, Shi W, Gao K, Rao J. Procedure and clinical assessments of malariotherapy: recent experience in 20 HIV patients. Chin Med J. 2003;116(7):1016-21. Accessed on 2006-05-18 at: http://www.cmj.org/Periodical/PDF/2003/200371016.pdf
Chen XP, et al. Impact of Acute Vivax Malaria on the Immune System of HIV-Positive Subjects. Poster No. 149. AIDS Vaccine. 2001. Accessed on 2005-09-10 at: http://web.archive.org/web/20030721190418/http://188.8.131.52/Posters/149.1.a.pdf
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;14(4):224-8. Accessed on 2005-09-10 at: http://www.bioethicswatch.org/foia/imt_cjms1999.pdf
Chen XP, Heimlich HJ, Xiao BQ, Liu SG. Interaction of Malaria and HIV Infection: Malariotherapy For AIDS. Hong Kong AIDS Conference. 1996. Accessed on 2005-09-10 at: http://www.csu.med.cuhk.edu.hk/hkaids/research/b03.htm
The investigators report that amajority of the 8 HIV patients experienced a sustained increase in CD4 levels during our 1-2 years follow up without further treatment of any kind, and all remained clinically well.Presumably the assessment does not include the deceased subject among this group. (5)
Heimlich HJ, Chen XP, Xiao BQ, Liu SG, Lu YH, Spletzer EG, Yao JL. CD4 response in HIV+ patients treated with malariotherapy. Int Conf AIDS 1996 Jul 7-12;11:91 (abstract no. We.B.3200). Accessed on 2005-09-10 at: http://www.aegis.com/conferences/iac/1996/web3200.html
Heimlich HJ, Chen XP, Xiao BQ, Liu SG, Lu YH, Spletzer EG, Yao JL. Malariotherapy For HIV Patients. Presented by Dr. Henry Heimlich at the First International Conference on Immunology and Aging, National Institutes of Health, Bethesda, June 18, 1996. Accessed on 2006-09-09 at: http://web.archive.org/web/20021022101930/http://www.heimlichinstitute.org/malariohiv.html
The presentation above was published as:
Heimlich HJ, Chen XP, Xiao BQ, Liu SG., Lu YH, Spletzer EG, Yao JL. Malariotherapy for HIV patients. Mech Ageing Dev. 1997;93(1-3):79-85. Abstract available at: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9089572
Austin SC, Stolley PD, Lasky T. The history of malariotherapy for neurosyphilis. Modern parallels. JAMA. 1992;268(4):516-9. Abstract available at: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=1619744
Albert MR. Reminiscence – Fever therapy for general paresis. International Journal of Dermatology. 2000;38(8): 633-37. Abstract available at: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10487458&dopt=Abstract
Hoffman SL. Experimental Challenge of Volunteers with Malaria. Ann Intern Med. 1997;127(3):233-235. Accessed on 2006-09-30 at: http://www.annals.org/cgi/content/full/127/3/233
Raju TNK. Hot Brains: Manipulating Body Heat to Save the Brain. Pediatrics. 2006;117(2):e320-321. Accessed on 2006-09-08 at: http://pediatrics.aappublications.org/cgi/reprint/117/2/e320
Unbound MedLine, s. v. malariotherapy. Accessed on 2008-03-04 at: http://www.unboundmedicine.com/medline/ebm/research/malariotherapy
Updated 2004-12-15: At some time within the last 30 days, the Heimlich Institute removed web pages promoting the scientific validity of malariotherapy and describing studies on subjects with HIV/AIDS conducted, sponsored, or proposed by the Institute. As a result, some links in this page go to web pages retrieved from the internet cache.
Malariotherapy for HIV. The Heimlich Institute. Undated.
The Validity of Malariotherapy. The Heimlich Institute. Undated.
Malariotherapy: An Affordable and Accessible Treatment For HIV/AIDS. Presented by Dr. Henry Heimlich at the PanAfrica 2002 AIDS Conference, October 31, 2002.
Malariotherapy Papers / What is Malariotherapy?
Malaria and AIDS Epidemics in Africa. The Heimlich Institute. Undated.
Heimlich tries using malaria as low-cost HIV treatment. Michael Woods. The Toledo Blade. 1996-07-15.
Link found between mother's malaria and child's HIV. Bennen Buma Gana. SciDevNet. 2005-11-18.
Wolf LE, Lo B. Ethical Dimensions of HIV/AIDS. HIV InSite Knowledge Base Chapter, August 2001. Accessed on 2006-09-08 at: http://hivinsite.ucsf.edu/InSite?page=kb-08-01-05
Whitworth J. Malaria and HIV. HIV InSite Knowledge Base Chapter, March 2002. Accessed on 2006-09-08 at: http://hivinsite.ucsf.edu/InSite?page=kb-05&doc=kb-05-04-04
Malaria and HIV/AIDS: Interactions and Implications. Conclusions of a Technical Consultation Convened by WHO. World Health Organization. 2004-06-23 through 25. Accessed on 2006-09-08 at: http://www.who.int/hiv/pub/prev_care/en/WHO%20Malaria%20and%20AIDS.pdf
U.S. and international research guidelines oblige investigators to inform research subjects of any new information during the course of enrollment that might prompt the subjects to reconsider their decision to participate. Has there been significant new data since subjects were initially enrolled in the malariotherapy trial? WHO concludes there is detrimental interaction between malaria and HIV:
Among adult men and non-pregnant women, HIV/AIDS may augment the risk of malarial illness, especially in those with advanced immunosuppression. In areas of unstable malaria transmission, HIV-infected adults may be at increased risk of developing severe malaria. HIV-infected adults with low CD4 cell counts may also be more susceptible to treatment failure of anti malarial drugs. Furthermore, acute malaria episodes temporarily increase viral replication and hence HIV viral load. As an important cause of anaemia, malaria frequently leads to blood transfusions, which is a potential risk factor for HIV infection (see Box 2).
This report prepared by Human Rights Watch describes endemic prejudice against persons diagnosed with HIV/AIDS, and draws attention to a number of situations in which this prejudice has caused PLWAs to loose fundamental civil liberties. The conditions described create formidable challenges for even the most highly qualified U.S. researchers working in the field.
Locked Doors: The Human Rights of People Living with HIV/AIDS in China. Human Rights Watch. August 2003. Accessed on 2006-09-08 at: http://www.hrw.org/reports/2003/china0803/
Defusing China's Time Bomb Sustaining the Momentum of China's HIV/AIDS Response, A report of the CSIS HIV/AIDS Delegation to China. Center for Strategic and International Studies (CSIS). April 13-18, 2004. Accessed on 2006-09-08 at: http://web.archive.org/web/20040626050636/http://csis.org/china/040617_China_AIDS_Timebomb.pdf
Peng L, Linin J, Changhong Z, Xixi Z, Huiqiong Z, Kaisheng L. HIV Epidemiology, Trends and Control Policies in Guangdong Province. Hong Kong AIDS Conference, 1996. Accessed on 2006-09-08 at: http://www.csu.med.cuhk.edu.hk/hkaids/research/a10.htm
In an apparent attempt to defend himself against allegations of scientific misconduct in the falsification of a case report describing the alleged rescusitation of a near-drowning victim, Dr. Patrick posted these documents purporting to be hospital records from the case: http://www.bioethicswatch.org/foia/patrick_limaERnotes.pdf
1. U.S. Food and Drug Administration. Guidance for Institutional Review Boards and Clinical Investigators, 1998 Update. Accessed on 2004-09-28 at: http://www.fda.gov/oc/ohrt/irbs/informedconsent.html#waiver
2. Paul Kenneth Bronston, M.D. Accessed on 2007-04-13 at: http://www.ca-experts.com/exp_wit/pbronston.htm
3. Chappell LT. Letter to the editor. Cincinnati Enquirer. 2003-03-18. Accessed on 2004-09-28 at: http://www.enquirer.com/editions/2003/03/18/editorial_wwwedit2let18.html
Violations of federal regulations in study titled
A Pilot Study of Induced Malaria Therapy in 30 Human Immunodeficiency Virus Positive Individuals: Masiello S. FDA warning letter to Great Lakes College of Clinical Medicine Institutional Reveiw Board. 2000-03-09, pp. 4, 9-10: http://www.circare.org/foia2/fda_glccm20000309.pdf
4. Death of subject no. 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;14(4):224-8, p. 227: http://www.bioethicswatch.org/foia/imt_cjms1999.pdf
Death of subject no. 12: Chen XP, Xiao B, Shi W, Xu H, Gao K, Rao J, Zhang Z. Impact of acute vivax malaria on the immune system and viral load of HIV-positive subjects. Chin Med J. 2003;116(12):1810-1820, p. 1812. Accessed on 2007-04-13 at: http://www.cmj.org/Periodical/PDF/2003/2003121810.pdf
5. Death of subject no. 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;14(4):224-8, p. 227: http://www.bioethicswatch.org/foia/imt_cjms1999.pdf
Last Updated: 2009-03-12
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