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Malario-Therapy For HIV (Henry Heimlich MD)

Updated 2004-12-15: At some time during the last 30 days or so, the Heimlich Institute removed web pages describing malariotherapy 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; the dates on which such web pages were posted and retrieved have been added. Editor's comments appear in Arial font gray text.

Protocol

I am at a loss to explain why Dr. Wilbert Jordan, M.D. is listed as a co-investigator with Dr. Heimlich in the protocol.

Informed Consent

Notice the enormously long waiver in the informed consent purporting to compel research subjects and their survivors to give up their rights to sue for damages should they be harmed or killed. Why didn't Dr. Heimlich and the IRB comply with federal regulation for informed consent? The applicable FDA guidance 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.

Expert Assessments of the Heimlich Institute's Clinical Trial Titled Induced Malaria as Therapy for HIV Infection

US Centers For Disease Control (CDC)

blue orb Chief, Malaria Branch, DPD NCID, Associate Director for Science, HIV NCID, Chief, Bacterial Zoonoses Branch, DVBID NCID, US Centers for Disease Control, comments on IMT (induced malariatherapy): A Potential Cure for AIDS, proposal circulated by The Heimlich Institute Foundation. (1993-04-29) pdf icon

US Food and Drug Administration (FDA)

Correspondence

blue orb Letter of Approval for Induced Malaria trial to Henry Heimlich M.D. from L. Terry Chappell M.D., Secretary, Great Lakes Association of Clinical Medicine Institutional Review Board (1 p.) [1994-05-27] pdf icon

blue orb Correspondence from Henry Heimlich M.D. to L. Terry Chappell M.D., Secretary, Great Lakes Association of Clinical Medicine Institutional Review Board, RE: FDA restrictions on IRB & status of clinical trial titled Heimlich Maneuver for Asthma (1 p.) [2000-04-25] pdf icon

blue orb Correspondence from Henry Heimlich M.D. to Jane Henney M.D., Commissioner, FDA, RE: FDA bias in description of IRB violations of federal regulations in approving Dr. Heimlich's malariotherapy research (5 pp.) [2000-05-04] pdf icon

blue orb Enclosure, Correspondence from Steven Masiello, FDA/CBER to L. Terry Chappell M.D., Secretary, Great Lakes College of Clinical Medicine Institutional Review Board, dated 2000-04-13, pp 9-10 pdf icon

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, Terry Chappell M.D., secretary of the 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.

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. In any event, FDA explained in exquisite detail precisely how the IRB failed to fulfill its obligation to protect research subjects in its approval of Dr. Heimlich's study. For the particulars, see the correspondence between FDA and the Great Lakes College of Clinical Medicine: http://www.bioethicswatch.org/foia/glccmindex.htm

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. ( 1 )

Learn more about the Great Lakes College of Clinical Medicine IRB: read the FDA Form 483s issued to the IRB, FDA warning letter issued to the IRB, correspondence between FDA and this organization, FDA warning letters issued to investigators conducting studies approved by this IRB, IRB membership, studies approved by the Great Lakes College of Clinical Medicine IRB, and the criminal indictment filed by the US government against a member of this IRB, and more.

Earlier Correspondence

Dr. Heimlich conducted earlier experiments in which research subjects with cancer and Lyme disease were infected with malaria, and to which the US Centers for Disease Control strenuously objected. The CDC memos and correspondence between Dr. Heimlich and the Centers for Disease Control are being indexed on this temporary holding page.

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Sponsorship and Funding

To a novice in financial matters, it seems as if Dr. Heimlich, the Heimlich Institute Foundation Inc., and its parent corporation, Deaconess Associations Inc. (as of 1998) have not been involved with the malariotherapy research on subjects with HIV/AIDS conducted by Dr. Chen in Guangzhou China since 1999 — nearly five years ago. A 2001 edition of the Heimlich Institute Foundation's newsletter claims that following a meeting with John Gall, chair of the Heimlich Institute board, Peter Akinola, Archbishop of the Anglican Church of Nigeria, obtained the support of the National Committee and has secured a physician to head the team and is currently recruiting doctors to participate in the treatment program. With all due respect, Archbishop Akinola is an inappropriate person to sponsor research of any sort, much less dubious research that's been condemned as unethical and lacking in scientific merit by American regulators. What can these men be thinking? The moment a powerful religious leader is associated with a research project, prospective subjects' spiritual devotion to their church could, and probably would, coerce them into enrolling in research for the wrong reasons – the idea is monstrous. ( 9 )

It appears the Heimlich Institute and Deaconess have additional possible clinical trial sites for malariotherapy experiments on subjects with HIV/AIDS in African nations, and are engaged in, or plan to conduct more malariotherapy experiments:

Both of these scenarios are indefensible: clinical investigators and sponsors are obligated to make every effort to avoid situations in which inequalities in authority and status might coerce people to enroll in research.

malariotherapy funding

Notes

1.Actress Amy Irving gave $50,000. Other major supporters included actress Estelle Getty, high-powered agent Sandy Bresler and ventriloquist Paul Winchell, according to Heimlich's foundation and other sources. Fueled by hundreds of thousands of dollars from such celebrity donations, Heimlich researchers have begun injecting a small group of HIV-positive men in China with malaria-infected blood. Pamela Warrick, Heimlich's Audacious Maneuver, Los Angeles Times, October 30, 1994.

2. Heimlich Institute Foundation Inc. IRS Form 990, FY 1998, p.2. Accessed 2004-12-05 at: http://www.guidestar.org/

3. Heimlich Institute Foundation Inc. IRS Form 990, FY 1999, p.2. Accessed 2004-12-05 at: http://www.guidestar.org/

4. Heimlich Institute Foundation Inc. IRS Form 990, FY 2000, p.2. Accessed 2004-12-05 at: http://www.guidestar.org/

5. Heimlich Institute Foundation Inc. IRS Form 990, FY 2001, p.2. Accessed 2004-12-05 at: http://www.guidestar.org/

6. Heimlich Institute Foundation Inc. IRS Form 990, FY 2002, p.2. Accessed 2004-12-05 at: http://www.guidestar.org/

7. Deaconess Health Association Fund, Inc. IRS Form 990, FY 2002, p. 15, Part II Schedule of Grants and Allocations: Heimlich Foundation – $ 106,139. There is nothing to indicate these funds were or were not spent on malariotherapy for HIV/AIDS research. Accessed 2004-12-05 at: http://www.guidestar.org/

8. Acknowledgements: Protocol, data management and information retrieval were supplied by the Heimlich Institute. Patient selection and care, and laboratory measurements were provided by the Municipal Health and Anti-Epidemic Station and the Yishou Hospital, both of Guangzhou. We thank the staffs of these institutions for their assistance. Henry J. Heimlich, Xiao Ping Chen, Bin Quan Xiao, Shu Gou Liu, Yue Hen Lu, Eric G. Spletzer, Ji Li Yao. Malariotherapy for HIV patients. Mechanisms of Ageing and Development 93 (1997) 84.

9. p. 228, Phase-1 Studies of Malariotherapy for HIV Infection. Chen, Xiaoping, Henry J. Heimlich, Binquan Xiao, Shugou Liu, Yuehen Lu, Jili Yao, and Eric G. Spletzer. Chin Med Sci J 1999 Dec;14(4):224-8

10. Impact of Acute Vivax Malaria on the Immune System of HIV-Positive Subjects. Chen, X. et al. Poster No. 149, AIDS Vaccine 2001 (2001-09-06 to 08). Accessed 2004-12-08 at: http://63.84.172.40/Posters/149.1.a.pdf pdf icon

11. Procedure and clinical assessments of malariotherapy: recent experience in 20 HIV patients. Chen X, Xiao B, Xu H, Shi W, Gao K, Rao J. Chin Med J 2003 Jul;116(7):1016-21. Accessed 2004-12-08 at: http://www.cma.org.cn/cmj/PDF/2003/200371016.pdf pdf icon

12. Impact of acute vivax malaria on the immune system and viral load of HIV-positive subjects. Chen X, Xiao B, Shi W, Xu H, Gao K, Rao J, Zhang Z. Chin Med J 2003; 116(12):1810-1820. Accessed 2004-12-08 at: http://www.cma.org.cn/cmj/PDF/2003/2003121810.pdf pdf icon

Media Coverage

Conference uninvites doctor advocating malaria therapy for AIDS
Anita Wadhwani, The Tennessean, 2004-10-30
URL: http://www.tennessean.com/local/archives/04/09/60558228.shtml?Element_ID=60558228

According to the article, A spokesman for Heimlich called the cancellation the latest consequence of a 'very weird Internet smear campaign' intended to discredit the doctor's theories, which have resulted in negative press accounts over the past several years.

It's tragic,' said spokesman Bob Kraft. 'He's 84 years old.'

A smear campaign is unnecessary to discredit the use of malariotherapy for HIV — the CDC did that roughly a decade ago. It's also difficult, if not impossible, to discredit that which has never been credited.( 2 ) UCLA thought so highly of Dr. Heimlich's research that when the university substantiated allegations that one of their faculty members was involved in this research in 2003, they determined that this involvement violated federal regulations as well as UCLA policy for the protection of human research subjects, and reported the involvement to the Office For Human Research Protections and the National Institutes of Health. No doubt the OHRP determination letter on this matter will be interesting. ( 3 )

What's tragic is a physician-researcher who steadfastly refuses to accept expert peer judgment that testing malariotherapy in research subjects with HIV/AIDS is unjustified and unethical. Worse yet, Dr. Heimlich is arrogant enough to reject the expert opinion of the regulator. When FDA took administrative action against the Great Lakes Association of Clinical Medicine IRB for improperly approving his research, Dr. Heimlich went so far as to assert in writing that the compliance director of FDA/Center for Biologics Evaluation and Research failed to understand the fundamental purpose of the IRB.

Dr. Heimlich asserted that the IRB's purpose is to review proposed medical research to determine its risk-benefit ratio and to supervise the progress of the research, particularly with regards to patient safety. Unfortunately this is rather wide of the mark. According to 21 CFR 56.102 (g), Institutional Review Board (IRB) means any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects. (emphasis added) ( 4 )

It's also misleading and incorrect to call research participants patients – they're research subjects, and to call them otherwise is to invite therapeutic misconception, whereby people agree to enroll in research in the mistaken belief that the purpose of research is to cure or ameliorate their condition. It isn't. When or if this happens, it's surely a benefit, but it's incidental nonetheless.

These difficulties are compounded by Dr. Heimlich's selection of a vulnerable subject population and the use of an extensively defective misleading instrument purporting to be an Informed Consent, whereby research subjects would:

agree to hold harmless the Heimlich Institute, Dr. Wilbert Jordan, Dr. Henry Heimlich, and all other health care providers involved in any way in this study. You understand that the use of Induced Malaria Therapy is on an experimental basis, and that this treatment has not been approved for use by the FDA or any other governmental agency. You voluntarily accept all risks associated with the use of the product, known or unknown. You understand that this agreement is binding on you, your estate, your heirs and assigns, and extends to all liability of any nature whatsoever, including any claim for negligence or failure to warn. You hereby bind yourself, your estate, your heirs and assigns, and any person or entity claiming to act on your behalf or on behalf of your estate, your heirs or assigns, not to make any claim against any person or entity whatsoever, for anything of value, arising out of the use, manufacture or distribution of this product.

At the same time, research subjects were also assured that Dr. Heimlich and the Heimlich Institute Foundation, Inc. do not practice medicine or provide medical care. This assertion might strike readers as nonsensical and perverse, given the fact that the previous paragraph demanded subjects waive their rights to claim damages arising from negligence or failure to warn, which arise from the fiduciary duties of a physician engaged in the practice of medicine.

And what is this product to which research subjects must forsake all claims? ( 5 )

This dubious effort to insulate the investigators from liability is matched by a clinical trial design which required research subjects to forego HIV therapies for duration of the treatment and follow-up period as a condition of enrollment. The duration of treatment and follow-up turned out to be as long as 24 months in some cases, according to a 1996 report by Dr. Heimlich. ( 6 )

Surely we can do better than this.

As for Dr. Heimlich's age, it's difficult to see how advancing age exempts him from the ethical obligations society imposes upon researchers. In any case, advancing age should bring advancing wisdom.

Heimlich may discuss malaria therapy for AIDS
Anita Wadhwani, The Tennessean, 2004-10-29
URL: http://www.tennessean.com/local/archives/04/09/60513010.shtml?Element_ID=60513010

Slightly off topic, but do we have some kind of national hobby?

3 Americans wanted for injecting HIV patients with animal vaccine
J Dey, Express India, 2004-10-24
URL: http://www.expressindia.com/print.php?newsid=37593

Dr. Eponymous
Brad Herzog, Cornell Alumni Magazine, March 2004
URL: http://heimlichinstitute.com/Cornell_Alumni_Magazine.html

Related
Heimlich Manuevers – Doctor Responds to Critics
Henry Heimlich MD, Cornell Alumni Magazine, MAY/JUNE 2004 VOLUME 106 NUMBER 6
URL: http://cornell-magazine.cornell.edu/Archive/2004mayjun/depts/Correspondence.html

Board rebukes AIDS evaluator — Doctor had helped Heimlich associate
Robert Anglen, The Cincinnati Enquirer, 2003-04-18
URL: http://www.enquirer.com/ editions/2003/04/18/loc_heimlich18.html

UCLA Medical Institutional Review Board Issues Its Determination in the Fahey Case Regarding Claims About Malariotherapy Studies for HIV
UCLA Press Release, 2003-04-16
URL: http://www.newsroom.ucla.edu/page.asp?id=4130

Malarial Treatment for Chinese AIDS Patients Prompts Inquiry in U.S.
Donald G. MacNeil Jr., The New York Times, 2003-03-04
URL: http://www.talkabouthealthnetwork.com/group/misc.health.aids/messages/90126.html

National News, Researcher Violated Rules, UCLA Says
CDC News Updates, April 16, 2003
URL: http://www.thebody.com/cdc/news_updates_archive/2003/apr16_03/fahey_violation.html

Heimlich Courts Controversy with AIDS Malaria Tests
Deena Beasley, Reuters, 2003-04-14 (Courtesy of AEGIS)
URL: http://www.aegis.com/news/re/2003/RE030415.html

Heimlich maneuvers in AIDS Therapy
Reuters, 2003-04-14
URL: http:// www.cnn.com/2003/HEALTH/conditions/04/14/health.aids.malaria.reut/index.html

Scientists linked to Heimlich investigated – Experiment infects AIDS patients in China with malaria
Robert Anglen, The Cincinnati Enquirer, 2003-02-16
URL: http://enquirer.com/editions/ 2003/02/16/loc_heimlich16.html

Therapy's value challenged
Jeyling Chou, The Daily Bruin Online, 2003-02-24
URL: http://www.dailybruin.ucla.edu/news/printable.asp?id=23065&date=2/24/2003

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

Heimlich: A victim of quackery
Timothy Gorski M.D., The Skeptic, The Newsletter of the North Texas Skeptics, Vol. 9, No. 5 1995-05
URL: http://www.ntskeptics.org/1995/1995may/may1995.htm#healthy

Heimlich's Audacious Maneuver
Pamela Warrick, The Los Angeles Times, 1994-10-30
URL: http://www.bioethicswatch.org/foia/media1.htm

Heimlich Maneuvers to Cure AIDS
CDC Summary, National AIDS Info Clearinghouse, 1994-11-02
URL http://www.aidsinfobbs.org/library/cdcsums/1994/449

CDC Chokes on AIDS Treatment Proposal
CDC Summary, National AIDS Info Clearinghouse, 1993-05-26
URL: http://www.aidsinfobbs.org/library/cdcsums/1993/084

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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.
Henry J. Heimlich, Xiao Ping Chen, Bin Quan Xiao, Shu Gou Liu, Yue Hen Lu, Eric G. Spletzer, Ji Li Yao
URL: http://web.archive.org/web/20040209070512/www.heimlichinstitute.org/malariohiv.html
Page last modified: 2004-02-09. Page retrieved from internet cache on 2004-12-15.

The presentation above appears to have been published as:

Malariotherapy for HIV patients
Heimlich HJ, Chen XP, Xiao BQ, Liu SG, Lu YH, Spletzer EG, Yao JL. Mech Ageing Dev. 1997 Feb; 93 (1-3): 79-85
URL: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9089572

Abstract: The objective of this study was to determine whether HIV patients who undergo malariotherapy experience beneficial immunological change without iatrogenic complications. In an approved, prospective study, asymptomatic. HIV-positive patients were inoculated with P. vivax malaria and the malaria infection was allowed to run a predetermined course according to standard malariotherapy protocols and was cured with chloroquine. After termination of the malaria, the patients have been followed for 2 years with clinical and immunological monitoring. In the first two HIV-positive patients, CD4 counts rose significantly from pre-malaria measurements and remain at normal levels 2 years later without further treatment of any kind. During this time, the patients remained clinically well. An additional six HIV-positive patients were treated with malariotherapy and have remained clinically well during the first 6 months after treatment. These initial studies demonstrate malariotherapy results in an increase in CD4 counts of HIV-positive patients. Furthermore, these increases persist beyond the presence of malaria, for at least 2 years.

The history of malariotherapy for neurosyphilis. Modern parallels
Austin SC, Stolley PD, Lasky T., JAMA, 1992 Jul 22-29;268(4):516-9
URL: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=1619744

Reminiscence – Fever therapy for general paresis
Michael R. Albert. International Journal of Dermatology 38 (8); 633-37
URL: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10487458&dopt=Abstract

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The Heimlich Institute

Malariotherapy for HIV, The Heimlich Institute
URL: http://web.archive.org/web/20040208100720/http://www.heimlichinstitute.org/malariotherapy.html
Page last modified: 2004-02-08. Page retrieved from internet cache on 2004-12-15.

The Validity of Malariotherapy
URL: http://web.archive.org/web/20040213042346/www.heimlichinstitute.org/mtvalidity.htm
Page last modified: 2004-02-13. Page retrieved from internet cache on 2004-12-15.

Malariotherapy: An Affordable and Accessible Treatment For HIV/AIDS
Presented by Dr. Henry Heimlich at the PanAfrica 2002 AIDS Conference, October 31, 2002
URL: http://web.archive.org/web/20040213030917/www.heimlichinstitute.org/PanAfrica2002.htm
Page last modified: 2004-02-13. Page retrieved from internet cache on 2004-12-15.

Index of Miscellaneous Pages on Malariotherapy for HIV/AIDS from the Heimlich Institute

Malariotherapy Papers
URL: http://web.archive.org/web/20040208221633/www.heimlichinstitute.org/malariopapers.html
Page last modified: 2004-02-08. Page retrieved from internet cache on 2004-12-15.

Malaria and AIDS Epidemics in Africa
URL: http://web.archive.org/web/20040206063245/www.heimlichinstitute.org/aidsafrica.html
Page last modified: 2004-02-20. Page retrieved from internet cache on 2004-12-15.

Heimlich tries using malaria as low-cost HIV treatment
Michael Woods, The Toledo Blade, 1996-07-15
URL: http://web.archive.org/web/20040209070314/www.heimlichinstitute.org/malaria.html
Page last modified: 2004-02-09. Page retrieved from internet cache on 2004-12-15.

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Recent Science on Malaria and HIV

Ethical Dimensions of HIV/AIDS
HIV InSite Knowledge Base Chapter August 2001. Leslie E. Wolf, JD, MPH, University of California San Francisco & Bernard Lo, MD, University of California San Francisco
URL: http://hivinsite.ucsf.edu/InSite-KB-ref.jsp?p

Malaria and HIV
HIV InSite Knowledge Base Chapter March 2002. James Whitworth, MD, FRCP, Medical Research Council Programme on AIDS, Uganda Virus Research Institute
URL: 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, June 23-25, 2004
URL: http://www.who.int/hiv/pub/prev_care/en/WHO%20Malaria%20and%20AIDS.pdf pdf file

US 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 antimalarial 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).

For adult men and non pregnant women, WHO experts suggest that the effect of HIV on malaria may cause

WHO experts suggest there is evidence to conclude that the effects of dual infection may result in

Finally, WHO believes there is evidence to show that the effects of dual infection increases HIV viral load. ( 8 )

Did the investigators supply this information to the subjects enrolled in the malariotherapy trial? And when did they do so?

Reports and Media Coverage of HIV/AIDS in China

This Human Rights Watch report 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 US researchers working in China.

Locked Doors: The Human Rights of People Living with HIV/AIDS in China, Human Rights Watch (August 2003)
Accessed 2004-07-21 at: http://www.hrw.org/reports/2003/china0803/ pdf icon

Defusing China's Time Bomb Sustaining the Momentum of China's HIV/AIDS Response, A report of the CSIS HIV/AIDS Delegation to China, April 13-18, 2004, Center for Strategic and International Studies (CSIS)
Accessed 2004-07-21 at: http://www.csis.org/china/040617_China_AIDS_Timebomb.pdf pdf icon

HIV Epidemiology, Trends and Control Policies in Guangdong Province
Lin Peng, Jiang Linin, Zeng Changhong, Zhao Xixi, Zhou Huiqiong, Lin Kaisheng. Hong Kong AIDS Conference (1996)
URL: http://www.csu.med.cuhk.edu.hk/hkaids/research/a10.htm

Varia

Playing Doctor
Thomas Francis, The Cleveland Scene, 2004-09-27
URL: http://www.clevescene.com/issues/2004-10-27/news/feature_print.html#

This article focuses on the medical credentials of Dr. Heimlich's long time professional colleague and collaborator, Dr. Edward Patrick, M.D. The article raises serious questions about the verification process for medical credentials.

This web site brings together a large number of original documents and by reference to them, raises serious questions about the credibility of Dr. Heimlich and a number of his contributions to medicine.

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Notes

1. L. Terry Chappell, M.D., Letter to the editor, Cincinnati Enquirer, 2003-03-18, accessed 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, FDA warning letter to Great Lakes College of Clinical Medicine IRB [2000-03-09] pp. 4, 9-10, online at: http://www.bioethicswatch.org/foia/fda_glccm20000309.pdf pdf icon; death of subject number 6, p. 227, Phase-1 Studies of Malariotherapy for HIV Infection. Chen, Xiaoping, Henry J. Heimlich, Binquan Xiao, Shugou Liu, Yuehen Lu, Jili Yao, and Eric G. Spletzer. Chin Med Sci J 1999 Dec;14(4):227, online at: http://www.bioethicswatch.org/foia/imt_cjms1999.pdf pdf icon; death of case 12, p. 1812, Impact of acute vivax malaria on the immune system and viral load of HIV-positive subjects. Chen X, Xiao B, Shi W, Xu H, Gao K, Rao J, Zhang Z. Chin Med J 2003; 116(12):1810-1820, online at: http://www.cma.org.cn/cmj/PDF/2003/2003121810.pdf pdf icon

2. CDC Chokes on AIDS Treatment Proposal, CDC Summary, National AIDS Info Clearinghouse, 1993-05-26, online at: http://www.aidsinfobbs.org/library/cdcsums/1993/084; objections to use of malariotherapy in Lyme disease reiterating unacceptable risk/benefit ratio in Update: Self-Induced Malaria Associated with Malariotherapy for Lyme Disease — Texas, CDC MMWR Weekly October 04, 1991 / 40(39);665-666, online at: http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/00015272.htm; Epidemiologic Notes and Reports Imported Malaria Associated with Malariotherapy of Lyme Disease — New Jersey, CDC MMWR Weekly December 07, 1990 / 39(48);873-875, online at: http://www.cdc.gov/mmwr/preview/mmwrhtml/00001850.htm; lack of controlled trials confirming efficacy of malariotherapy: The history of malariotherapy for neurosyphilis. Modern parallels. Austin SC, Stolley PD, Lasky T., JAMA, 1992 Jul 22-29;268(4):516-9.

3. UCLA Medical Institutional Review Board Issues Its Determination in the Fahey Case Regarding Claims About Malariotherapy Studies for HIV, UCLA Press Release, 2003-04-16, online at: http://www.newsroom.ucla.edu/page.asp?id=4130

4. In response to FDA's description of the ways in which the IRB failed to protect the rights and welfare of research subjects in their approval of the study titled A Pilot Study of Induced Malaria Therapy in 30 Human Immunodeficiency Virus Positive Individuals, Dr. Heimlich sent a vitriolic letter of complaint to FDA alleging, among other things, that the FDA investigator's statement indicates his failure to understand the fundamental purpose of the IRB. The IRB's purpose is to review proposed medical research to determine its risk-benefit ratio and to supervise the progress of the research, particularly with regards to patient safety. Correspondence from Henry Heimlich M.D. to Jane Henney M.D., Commissioner, FDA, (2000-05-04) pp. 3-4, online at: http://www.bioethicswatch.org/foia/hh_fda_20000504.pdf pdf icon ;   violations of federal regulations, FDA warning letter to Great Lakes College of Clinical Medicine IRB [2000-03-09] pp. 4, 9-10, online at: http://www.bioethicswatch.org/foia/fda_glccm20000309.pdf pdf icon; 21 CFR 56.102 (g), Protection of Human Subjects, Definitions: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=56&showFR=1

5. Informed consent, Induced Malaria as Therapy for HIV Infection, pp. 3-4, online at: http://www.bioethicswatch.org/foia/malarioth_icf.pdf pdf icon; Compare the representations in the informed consent asserting that Dr. Heimlich does not practice medicine or provide medical care with what Dr. Heimlich claimed in writing to FDA Commissioner Henney: Dr. Heimlich is the principal investigator for this research and was personally involved in all procedures mentioned. He made repeated trips to China to oversee patients' treatments., Correspondence from Henry Heimlich M.D. to Jane Henney M.D., Commissioner, FDA, (2000-05-04) pp. 3, online at: http://www.bioethicswatch.org/foia/hh_fda_20000504.pdf pdf icon

6. Methods – Institutional Review Board approval was obtained for this study. Criteria for acceptance included asymptomatic HIV infection, absence of other concurrent infections and willingness to not participate in other HIV therapies for duration of the treatment and follow-up period. Informed consent to participate in this clinical prospective study of malariotherapy for HIV infection was obtained. As part of the protocol, patients agreed to take appropriate measures to avoid risking HIV reinfection during the course of the study.;
Experimental Results – HIV patients were treated with one course of malariotherapy and had no complications. One patient's CD4 cells rose from 889 to 1260 and was 941 two years after malariotherapy; the second patient's CD4 cells rose from 269 to 953 and was 650 two years after treatment. These patients have remained well for two years with no further treatment of any kind. The other six patients treated with malariotherapy also remain clinically well after six months. (with chart);
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. Henry J. Heimlich, Xiao Ping Chen, Bin Quan Xiao, Shu Gou Liu, Yue Hen Lu, Eric G. Spletzer, Ji Li Yao, online at: http://web.archive.org/web/20040209070512/www.heimlichinstitute.org/malariohiv.html (page last updated on 2004-02-09; retrieved on 2004-12-15), with emphasis added. A subsequent publication by Chen & Heimlich in 1999 (see note 7, below) describes a follow up period ranging from 24 to 30 months.

7. Phase-1 Studies of Malariotherapy for HIV Infection. Chen, Xiaoping, Henry J. Heimlich, Binquan Xiao, Shugou Liu, Yuehen Lu, Jili Yao, and Eric G. Spletzer. Chin Med Sci J 1999 Dec;14(4):227, online at: http://www.bioethicswatch.org/foia/imt_cjms1999.pdf pdf icon

8. Malaria and HIV/AIDS: Interactions and Implications, Conclusions of a Technical Consultation Convened by WHO, June 23-25, 2004. Accessed 2004-11-05 at: http://www.who.int/hiv/pub/prev_care/en/WHO%20Malaria%20and%20AIDS.pdf pdf file

9. Heimlich Institute's Caring World. 2001;3: 3. Accessed 2004-12-08 at: http://www.heimlichinstitute.org/media/CaringWorldSummer01.pdf pdf icon


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Last Updated: 2005-03-30