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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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Visit the website maintained by Peter and Karen Heimlich for the most recent stories: http://medfraud.info/
A New Maneuver. Pamela Mills Senn. April 2007. Cincinnati Magazine.
Heimlich family maneuvers. Peter Korn. The Portland Tribune. 2007-04-13.
The Manuever. Chuck Goudie. ABC7 I–Team. 2006-11-17.
Dr. Henry Heimlich Widely Criticized. Robert Baratz. National Council Against Health Fraud, Quackwatch web site. 2006-10-12. Accessed on 2006-12-08 at: http://www.quackwatch.org/11Ind/heimlich.html
Is the Heimlich Maneuver Safe for Drowning Victims? Kevin Lamb. 2006-09-01. Dayton Daily News.
Outmaneuvered Part I. Thomas Francis. Radar Magazine. Published online on 2005-11-10.
Outmaneuvered Part II. Thomas Francis. Radar Magazine. Published online on 2005-11-11.
Son chokes on Heimlich's career. Dan Monk and Andrea Tortora. Cincinnati Business Journal. 2005-01-23.
Related: The Cincinnati Business Journal editorial explains the paper's decision to award its Lifetime Hero health care award to Dr. Heimlich, and adverts to an article describing their understanding of the issues involved with a number of Dr. Heimlich's activities. We respect the right of the Journal to bestow their award on anyone they choose. Writers Monk and Tortora claim their purpose was not to… to dismiss all criticism about his work, because some of it might be valid. Critics have included national medical groups and experts, as well.This statement suggests the Journal's understanding of some or all of the issues may be incomplete.
Some of the criticism,some of which might be valid,comes from:
- The Centers for Disease Control
- The Food and Drug Administration
- National Council for AIDS Prevention and Control of Mexico (CONASIDA)
- The American Heart Association
- Expert reviewers appointed by the Institute of Medicine at the National Academy of Science
- American Red Cross
- Opinions of AIDS experts included in the petition of Dr. Paul Bronston, M.D., concerning Dr. Heimlich's funding proposal titledIMT: A Potential Cure For AIDS
Criticism won't deter Hero award. Editorial. Cincinnati Business Journal. 2005-01-24.
Heimlich named Lifetime Hero; 72 to receive health care honors. Richard Curtis. Cincinnati Business Journal. 2004-12-27.
Mr. Johnson's article focuses on Dr. Heimlich's colleague, Glen Griffin, M.D., former Utah public health official who
tapped some professional contacts in Mexico City, paving the way for Heimlich's infamous 'malariotherapy' treatments on terminal cancer patients. In addition, he quotes expert opinion about the scientific and ethical issues involved in testing the Heimlich Maneuver for asthma.
The trouble with Henry. Shane Johnson. The Salt Lake City Weekly. 2004-12-30.
Mr. Guyette's article focuses on Dr. Heimlich and his promotion of the Heimlich Maneuver as the initial intervention in cases of near-drowning contrary to Red Cross and American Heart Association expert guidelines.
Off the deep end. Curt Guyette. Detroit Metro Times. 2004-12-08.
Related: Doctor and the skeptics. Letter to the editor. Henry Heimlich, M.D., with response of Curt Guyette. 2004-12-15.
Conference uninvites doctor advocating malaria therapy for AIDS. Anita Wadhwani. The Tennessean. 2004-10-30.
According to this 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.'
smear campaign is unnecessary to discredit the use of malariotherapy for HIV because 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. (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 so hubristic as 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 provide them with direct medical benefit. 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, claims 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.
Mr. Francis' article focuses on Dr. Heimlich's colleague, Dr. Edward A. Patrick, M.D., his medical credentials, and his role in the development and promotion of the Heimlich Maneuver for various purposes.
Playing Doctor. Thomas Francis. Cleveland Scene. 2004-10-27.
Related: Gore in the ER. Letter to the Editor. Cleveland Scene. 2004-11-17.
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.
Mr. Volk's article focuses on use of the Heimlich Maneuver as the initial intervention in cases of near-drowning contrary to Red Cross and American Heart Association expert guidelines.
Deadly Medicine. Steve Volk. Philadelphia Weekly. 2004-09-15.
Mr. Francis' article focuses on the use of the Heimlich Maneuver as the initial intervention in cases of near-drowning contrary to Red Cross and American Heart Association expert guidelines.
Heimlich's Maneuver. Thomas Francis. Cleveland Scene. 2004-08-11.
Related: Cons from the pros. Letter to the Editor. Cleveland Scene. 2004-09-01.
Dr. Eponymous. Brad Herzog. Cornell Alumni Magazine. March 2004.
Related: Heimlich Manuevers – Doctor Responds to Critics. Henry Heimlich M.D. Cornell Alumni Magazine. May/June 2004 Volume 106 Number 6.
In his response to Dr. Heimlich's letter (above), author Brad Herzog refers readers to correspondence of 2004-06-01 from B. Chris Brewster, President, United States Lifesaving Association (USLA), to Jim Roberts, Editor, Cornell Alumni Magazine. Mr. Brewster's letter reiterates the scientific and ethical basis upon which USLA objects to Dr. Heimlich's promotion of his maneuver as a first response in drowning rescue. Available from http://www.circare.org/foia2/Brewster_CAM_20040601.pdf
Related recent correspondence between Dr. Heimlich and the United States Lifesaving Association is available on the USLA web site. Peter Wernicki, M.D., Medical Advisor, United States Lifesaving Association, to Henry Heimlich, M.D. 2004-03-31, and letter in reply from Henry Heimlich, M.D. to Peter Wernicki, M.D. 2004-04-19. Accessed on 2007-04-06 at: http://www.usla.org/PublicInfo/library/HeimlichLetterandReplyMARAPR04.pdf
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.
In addition to these NIH funds from the Fogarty International Program (mis)used to support malariotherapy research in China, principal investigator Xiao Ping Chen, M.D., Ph.D., is currently funded by NIH as
Co-leader of clinical trials conducted by China-CIPRA (Comprehensive International Program for Research on AIDS (CIPRA) in China). Accessed on 2007-04-06 at: http://web.archive.org/web/20051130081411/http://www.chinaids.org.cn/cipra/e-index/people.asp
Malarial Treatment for Chinese AIDS Patients Prompts Inquiry in U.S. Donald G. MacNeil Jr. The New York Times. 2003-03-04.
Researcher Violated Rules, UCLA Says. CDC News Updates. 2003-04-16.
Heimlich Courts Controversy with AIDS Malaria Tests. Deena Beasley. Reuters, courtesy of AEGIS. 2003-04-14.
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
Related: Malariotherapy worth investigating. L. Terry Chappell, M.D. Letter to the Editor. The Cincinnati Enquirer. 2003-03-18.
Therapy's value challenged. Jeyling Chou. The Daily Bruin Online. 2003-02-24.
Researchers' possible link to malariotherapy scrutinized. Edward Chiao & Jeyling Chou. The Daily Bruin Online. 2002-11-22.
Heimlich: A victim of quackery. Timothy Gorski M.D. The Skeptic The Newsletter of the North Texas Skeptics. Vol. 9. No. 5 1995-05.
Heimlich's Audacious Maneuver. Pamela Warrick. The Los Angeles Times. 1994-10-30.
Heimlich Maneuvers to Cure AIDS. CDC Summary National AIDS Info Clearinghouse. 1994-11-02.
CDC Chokes on AIDS Treatment Proposal. CDC Summary National AIDS Info Clearinghouse. 1993-05-26.
1. L. Terry Chappell M.D. 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: FDA warning letter to Great Lakes College of Clinical Medicine IRB (2000-03-09) pp. 4, 9-10: http://www.circare.org/foia2/fda_glccm20000309.pdf
Death of subject number 6: p. 227, Phase-1 Studies of Malariotherapy for HIV Infection. Chen, XP, Heimlich JH, Xiao B, Liu S, Lu Y, Yao J, Spletzer EG. Chin Med Sci J. 1999 Dec;14(4):227: http://www.bioethicswatch.org/foia/imt_cjms1999.pdf
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. Accessed on 2007-04-06 at: http://www.cmj.org/Periodical/PDF/2003/2003121810.pdf
2. CDC Chokes on AIDS Treatment Proposal. CDC Summary, National AIDS Info Clearinghouse. 1993-05-26. Accessed on 2005-01-03 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. MMWR Weekly. October 04, 1991 / 40(39);665-666. Accessed on 2007-04-06 at: http://www.cdc.gov/mmwr/preview/mmwrhtml/00015272.htm; Epidemiologic Notes and Reports Imported Malaria Associated with Malariotherapy of Lyme Disease — New Jersey. MMWR Weekly. December 07, 1990 / 39(48);873-875. Accessed on 2005-01-03 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. Accessed on 2005-01-03 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. Henry Heimlich M.D. to Jane Henney M.D., Commissioner, FDA (2000-05-04) pp. 3-4: http://www.circare.org/foia2/hh_fda20000504.pdf
Violations of federal regulations: FDA warning letter to Great Lakes College of Clinical Medicine IRB (2000-03-09) pp. 4, 9-10: http://www.circare.org/foia2/fda_glccm20000309.pdf
21 CFR 56.102 (g) Protection of Human Subjects, Definitions. Accessed on 2005-01-03 at: 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: http://www.circare.org/foia2/imtconsentform_19931029.pdf
Compare the representations in the consent form 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. Henry Heimlich M.D. to Jane Henney M.D., Commissioner, FDA (2000-05-04) pp. 3: http://www.circare.org/foia2/hh_fda20000504.pdf
6. 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. Accessed on 2007-04-06 at: http://web.archive.org/web/20040209070512/www.heimlichinstitute.org/malariohiv.html (emphased added)
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.
A subsequent publication by Chen & Heimlich in 1999 (see note 7, below) describes a
follow up period between 24 and 30 months.
7. Phase-1 Studies of Malariotherapy for HIV Infection. Chen, XP, Heimlich JH, Xiao B, Liu S, Lu Y, Yao J, Spletzer EG. Chin Med Sci J. 1999 Dec;14(4):227: http://www.bioethicswatch.org/foia/imt_cjms1999.pdf
Malaria and HIV/AIDS: Interactions and Implications. Conclusions of a Technical Consultation Convened by WHO. June 23-25, 2004. Accessed on 2004-11-05 at: http://www.who.int/hiv/pub/prev_care/en/WHO%20Malaria%20and%20AIDS.pdf
9. Heimlich Institute's Caring World. 2001;3:3. Accessed on 2007-04-06 at: http://web.archive.org/web/20030421015912/http://www.heimlichinstitute.org/media/CaringWorldSummer01.pdf
10. 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):81. The paper is reproduced without pagination on the Heimlich Institute Foundation. Accessed on 2007-04-06 at: http://web.archive.org/web/20040209070512/www.heimlichinstitute.org/malariohiv.html
11. 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): 225: http://www.bioethicswatch.org/foia/imt_cjms1999.pdf
12. Phase-1 Studies of Malariotherapy for HIV Infection. Chen, XP, Heimlich JH, Xiao B, Liu S, Lu Y, Yao J, Spletzer EG. Chin Med Sci J. 1999 Dec; 14 (4): 227: http://www.bioethicswatch.org/foia/imt_cjms1999.pdf
13. Henry Heimlich M.D. to Jane Henney M.D., 2000-05-04, p.3: http://www.circare.org/foia2/hh_fda20000504.pdf
14. Henry Heimlich M.D. to Jane Henney M.D., 2000-05-04, p.3: http://www.circare.org/foia2/hh_fda20000504.pdf
15. Informed consent, Induced Malaria as Therapy for HIV Infection, p. 2: http://www.circare.org/foia2/imtconsentform_19931029.pdf
16. Henry Heimlich M.D. to Jane Henney M.D., 2000-05-04, p.3: http://www.circare.org/foia2/hh_fda20000504.pdf
17. FDA Warning Letter to Great Lakes College of Clinical Medicine IRB and L. Terry Chappell, M.D. (2000-03-09) p.9: http://www.circare.org/foia2/fda_glccm20000309.pdf; Great Lakes College of Clinical Medicine IRB to FDA (2000-05-26) p.2: http://www.circare.org/foia2/glccm_fda20000526.pdf
18. Transtracheal oxygen delivery systems on the market (not a complete listing): Heimlich MicroTrach ™ (brochure): http://web.archive.org/web/20021220154053/www.heimlichinstitute.org/MicroTrach1.html; The Heimlich Institute Foundation information on the Heimlich MicroTrach: http://web.archive.org/web/20021220073640/http://www.heimlichinstitute.org/microtrach.html. According to a 1998 review article (see the Postgraduate Medicine review article below), the Heimlich MicroTrach is (or was) distributed by Life Medical Technologies of Salt Lake City, Utah. According to the Utah Department of Commerce (Business Entity search online at: https://secure.utah.gov/bes/action/index), this Delaware corporation is no longer registered in Utah. This corporation currently does business as Zynex Medical Holdings: http://www.secinfo.com/$/SEC/Registrant.asp?CIK=846475&View=Registrant; Transtracheal Systems Inc.: http://www.transtracheal.com/products/scoop_products.asp; Cook ITOC, Cook Inc, Critical Care Division.
Safety and efficacy: American Association of Respiratory Care (AARC) Clinical Practice Guideline, Oxygen Therapy in the Home or Extended Care Facility. Accessed on 2007-04-06 at: http://web.archive.org/web/20021208011212/http://www.rcjournal.com/online_resources/cpgs/othefcpg.html; Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Accessed on 2005-01-02 at: http://www.guideline.gov/summary/pdf.aspx?doc_id=5591&stat=1&string=; Long-term oxygen therapy for COPD. Improving longevity and quality of life in hypoxemic patients. Weg JG, Haas CF. Postgraduate Medicine 1998; 103 (4): 143-158. Accessed on 2005-01-02 at: http://www.postgradmed.com/issues/1998/04_98/weg.htm; Centers for Medicare and Medicaid Services, National Coverage Determination, Home Oxygen Therapy. 2007-04-06 at: http://tinyurl.com/y32xmc
19. Henry J. Heimlich, M.D., Biography. Accessed on 2007-04-06 at: http://web.archive.org/web/20051217220501/http://www.heimlichinstitute.org/bio.html
20. Heimlich MicroTrach, Devices@FDA: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=PMN&id=K895130
21. FDA Enforcement Report. 1990-05-29. Accessed on 2005-01-02 at: http://www.fda.gov/bbs/topics/ENFORCE/ENF00067.html
22. Heimlich, HJ Without Animals: Advantages and Safety of Clinical Research. Proceedings of the First International Medical Conference Against Vivisection. Israel, 1989. Accessed on 2005-01-02 at: http://www.animalvoices.org/ADAV/heimlich.htm
23. Heimlich Devises Portable Breathing Device for Lung Disease Victims. Associated Press. 1984-04-18.
24. Henry J. Heimlich, M.D., Biography. Accessed on 2007-04-06 at: http://web.archive.org/web/20051217220501/http://www.heimlichinstitute.org/bio.html
25. Heimlich falsely claims he invented surgical procedure. Robert Anglen. The Cincinnati Enquirer. 2003-03-16. Accessed on 2005-01-03 at: http://www.enquirer.com/editions/2003/03/16/loc_heimlich16.html
26. Dr. Heimlich: The Man Behind the Manoever, Part II. Robert McKay. Saturday Evening Post. December 1986, p. 3. Accessed on 2005-01-03 at: http://www.findarticles.com/p/articles/mi_m1189/is_v258/ai_4530957/pg_3 (2007-04-06: no longer available online.)
Last Updated: 2008-02-24
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