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Malariotherapy for HIV (Henry Heimlich MD) Pt. V

blue square What's Wrong With This Research
blue square Study Documents     blue square Regulatory Correspondence
blue square Funding and Sponsorship     blue square Media Articles
blue square Research Publications     blue square Research on Malaria and HIV
blue square Credibility     blue square FOIA: UCLA, NIH and John Fahey, M.D.   blue square Varia

Credibility

Malariotherapy for HIV/AIDS

Editor's comments appear in Arial font gray text.

In a recent editorial published by the Cincinnati Business Journal, the following information about Dr. Heimlich and his malariotherapy research in China was offered:

He tested his theory in China with a three-year study that ended in 1996. He claims the Chinese experiments provide evidence that malarial fever boosts the body's immune system, enabling it to fight AIDS. In 1997, he reported that eight patients were treated with a curable form of malaria. Two years later, one patient had died of unrelated causes. Seven others showed positive signs of recovery with elevated levels of an immune system cell that is targeted by the AIDS virus. Henry Heimlich said he doesn't know what became of the patients after 1997. He said the Heimlich Institute no longer conducts or funds malariotherapy research but continues to follow research on the topic, and he believes it's a valid treatment. (19)

We assume this information is accurate because the article describes interviews with both Dr. Heimlich and Bob Kraft, the press agent retained by the Heimlich Institute Foundation Inc. On this basis, it appears there are some problems.

1. If Dr. Heimlich's study in China was in fact a three-year study that ended in 1996, he started his study without ethical or scientific review and approval: institutional review board approval (such as it was) was obtained by Dr. Heimlich from the Great Lakes College of Clinical Medicine IRB on 1994-05-27. (20)

A) If Dr. Heimlich's study in China was in fact a three-year study that ended in 1996, why would the 2000-05-05 meeting minutes of the Great Lakes College of Clinical Medicine IRB record that the IRB terminated Dr. Heimlich's induced malaria study by the FDA request in the letter to the IRB of April 13th, approximately four years after Dr. Heimlich (now) claims the study was closed? Even this IRB could not terminate a study that had been closed for four years. (32)

B) If Dr. Heimlich's study in China was in fact a three-year study that ended in 1996, why do the 2000-02-25 meeting minutes of the Great Lakes College of Clinical Medicine IRB record extending approval of Dr. Heimlich's malariotherapy study for the next six months, through 2000-09-16?

Continuing Review/Updates

Dr. Heimlich's study S043 Induced Malaria Therapy … The treated HIV patients in this study are still doing well. The exception of not including the Patient Bill of Rights due to complications of the data being collected in China, and a request to submit data to the IRB, the motion to approve Dr. Heimlich's study S043 Induced Malaria Therapy … was given at significant risk with approval until September 16, 2000 by John Trowbridge and 2nd by Tim Guilford. The vote was 11-0 in favor. (33)

Extension of IRB approval isn't automatic: Dr. Heimlich would have applied for extension of approval for his malariotherapy research in writing at least two weeks before approval expired, according to the GLCCM IRB Rules. (34)

C) This discrepancy raises obvious questions: why would the 2000-02-25 GLCCM IRB meeting minutes record that the treated HIV patients in this study are still doing well unless Dr. Heimlich told them this?

D) If Dr. Heimlich doesn't know what became of the patients after 1997, how could he tell the GLCCM IRB that the treated HIV patients in this study are still doing well? It's a cinch only one of his statements can be true. Or neither of them.

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If Dr. Heimlich doesn't know what became of the patients after 1997, why did he describe their condition as of 2001 in response to questions posed by the New York Times?

The study, which ended in 1996, reported then that all eight were alive and had normal CD4 counts; the H.I.V. virus cripples the immune system by destroying CD4 cells. Dr. Heimlich said on Feb. 21 that, as of his last contact with his Chinese colleagues in 2001, one man was dead of non-AIDS-related causes and the rest were alive. (35)

3. If Dr. Heimlich doesn't know what became of the patients after 1997, how might the Heimlich Institute Foundation Inc. justify continued fundraising for malariotherapy research between 1998 and today? (21)

A) If the Heimlich Institute no longer conducts or funds malariotherapy research, when did they stop? This question is especially pertinent given the current solicitation for funds to support malariotherapy for HIV/AIDS on the Heimlich Institute Foundation web site, as well as similar solicitations on the web site of its parent corporation, Deaconess Associations Inc. (22)

B) According to their tax returns, between 1998 and 2002, the Heimlich Institute Foundation Inc. expended $173,332 on AIDS research and education. Given Dr. Heimlich's claims published by the Journal, it's reasonable to ask how the Heimlich Institute Foundation, a 501(C)3 corporation, spent the donations it solicited and received for malariotherapy for HIV/AIDS during this period. (23)

In response to charges of gross deviation from widely shared ethical principles governing human research leveled at Dr. Heimlich over his malariotherapy for HIV/AIDS research by Robert Baratz, M.D., Ph.D, president of the National Council Against Health Fraud, the Journal printed this:

Henry Heimlich gave the Courier a June 8, 2000, letter to him from the Food and Drug Administration, which says the Chinese government is the appropriate authority for oversight of such foreign research, not a United States-based IRB.

We appreciate that the Journal is in a difficult position, so we thought we'd help by pointing out the obvious:

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We discuss the ethical issues arising from Dr. Heimlich's malariotherapy research in detail elsewhere, but it's worth quoting FDA's explanation of what the Great Lakes College of Clinical Medicine IRB did wrong in its approval of Dr. Heimlich's research, and why it was inappropriate for him to have sought IRB approval in the first place. Because Dr. Heimlich was not affiliated with a US research institution, and because the study was conducted outside the US, FDA regulations did not apply to Dr. Heimlich himself. That said, it's a fair statement that the issues FDA found objectionable do reflect on Dr. Heimlich's familiarity with scientific and ethical principles of human research. From the FDA letter of 2000-04-13, to Great Lakes College of Clinical Medicine IRB, L. Terry Chappell, M.D.:

7. We have the following comments regarding the IRB's review and approval of the study entitled Induced Malaria as Therapy for HIV Infection. We strongly disagree that the IRB properly considered the scientific merit of the study and that the protocol minimized risks to subjects concerning this study, as expressed in you response letter dated March 17, 2000, for the following reasons:

A. The protocol is inadequate in that it does not describe what testing was done to screen the malarial parasite donors. The direct injection of blood from a malaria parasite donor into a study subject would not be permitted in the U.S. because cultured malaria parasites are available. The IRB did not review information about how subjects and malaria parasite donors are recruited and screened.

B. The statement in the response letter that the IRB's approach [to the study] was no different than if the research was conducted in the U.S. demonstrates 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.

Page 10 – Great Lakes College of Clinical Medicine IRB

C. We reject your position that the IRB was able to consider the community attitudes of the Chinese population in which the research was to be conducted. Given the great differences between Chinese and American cultures, we do not accept that the GLCCM was capable of understanding Chinese attitudes about the research. This is one reason, among many, that the academic institution in China that was associated with the research, as referenced in your response letter, should have obtained governmental and approval from a local IRB (or equivalent body).

D. Although Dr. Heimlich's Foundation is apparently underwriting this research study, he has no responsibilities for subject screening, study procedures, or evaluation of the subjects, and appears to have no direct supervisory role over the study. Dr. Heimlich is not obligated to obtain IRB approval for his limited involvement in this study, and, indeed, in this case, it was inappropriate for him to do so.

E. The IRB file for this study did not contain the Chinese translation of the protocol or consent form. In general, when study subjects are non-English speakers, the IRB must assure that the consent form translation is accurate.

F. Please describe the IRB's efforts to determine that this study had been approved by the appropriate office in the Ministry of Health and by the local institution(s) where the research was conducted. The IRB should rescind approval of this study and defer the human subject protection responsibilities to the responsible Chinese authorities.

Please provide documentation that the IRB has informed the Chinese clinical investigator of his responsibility to obtain the appropriate Chinese government and local institutional approval for their research. (24)

It's also unclear that Dr. Heimlich's a three-year study that ended in 1996 in China did, in fact, have ethical approval from local Chinese government authorities.

If it's true that that Dr. Heimlich's a three-year study that ended in 1996 had appropriate review and approval from review boards from municipal, provincial and Ministry of Health authorities, as well as the provincial scientific committee, why isn't this described in the published articles? The fact that these alleged approvals are omitted argues that no such approvals were obtained. (26)

The 2000-06-08 FDA letter to Dr. Heimlich (received by the Journal) was in response to his vituperative letter of 2000-05-04 to FDA Commissioner Jane Henney, M.D., in which he wrote, inter alia:

The research is being carried out by the Chinese government's equivalent of the U.S. Public Health Service, which is under their Ministry of Health. The senior Chinese scientific investigator is the Director of the Center for AIDS Control and Research of the Centers for Public Health and Disease Control (i.e., the Chinese Public Health system).  

The project received independent approval from review boards from municipal, provincial and Ministry of Health authorities, as well as the provincial scientific committee. (25)

Dr. Heimlich's statement that the senior Chinese scientific investigator is the Director of the Center for AIDS Control and Research of the Centers for Public Health and Disease Control should be corrected to read the senior Chinese investigator is the Director of the Division of AIDS Control and Prevention, Guangzhou Center for Disease Control and Prevention.

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In his letter of 2000-05-04 to FDA Commissioner Henney, Dr. Heimlich makes a number of peculiar statements which are contradicted elsewhere.

Dr. Heimlich reiterated his belief that FDA had no jurisdiction over his research because:

We have an earlier letter from the FDA indicating that the FDA has no authority over our research, since we are not interested in developing a 'product' or filing an investigational application ('IND') …

If this is accurate, why would Dr. Heimlich's purported informed consent for malariotherapy for HIV/AIDS compel subjects to release all future claims on this product?

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. (36 [emphasis mine])
 

But this would miss the point: FDA did have jurisdiction over the GLCCM IRB, and the FDA administrative action of 2000-03-09 catalogued approval of Dr. Heimlich's induced malariotherapy for HIV/AIDS study, and its deficient informed consent with the rest of the IRB's violations of federal regulations — simply put: Dr. Heimlich's trial was among the ways in which the Great Lakes Association of Clinical Medicine IRB failed to protect the rights and welfare of human research subjects.

FDA objected to the Great Lakes Association of Clinical Medicine IRB's approval of Dr. Heimlich's malariotherapy protocol because, inter alia:

Although Dr. Heimlich's Foundation is apparently underwriting this research study, he has no responsibilities for subject screening, study procedures, or evaluation of subjects, and appears to have no direct supervisory role over the study. (1)

Dr. Heimlich responded that:

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. (2)

To Chinese research subjects enrolled in this trial, however, Dr. Heimlich made quite different representations in his informed consent:

Neither Dr. Heimlich nor the Heimlich Institute Foundation Inc. practices medicine or provide (sic) medical care. They are involved in the malariatherapy project solely from the standpoint of evaluating scientific data. (3)

These statements are mutually exclusive: either Dr. Heimlich was personally involved in his capacity as a physician or he was not. It's troubling that he appears to feel free to absolve himself of the responsibilities of principal investigator so far as the research subjects are concerned, — perhaps to forestall any litigation that might arise — yet also claim to act as principal investigator in correspondence with FDA during the course of attempting to justify submitting his malariotherapy study to the Great Lakes Association of Clinical Medicine IRB, which lacked authority to review and approve studies conducted exclusively outside the U.S.

In response to FDA's complaint that the GLCCM IRB had approved Dr. Heimlich's malariotherapy protocol despite the fact that it was inadequate in that it does not describe what testing is done to screen malarial parasite donors, Dr. Heimlich asserted that:

Our protocol states that: 1) the blood should only contain Plasmodium vivax, 2) that repeated thick and thin blood smear examination for parasites other than the desired Plasmodium should be carried out, 3) negative antibody screens for syphilis, hepatitis, HIV, CMV, and any other infections suggested by history and physical examination are required. This is in accordance with standard blood screening procedures used for transfusion blood. (29)

This assertion is incorrect. Dr. Heimlich's protocol for the study titled Induced Malaria as Therapy for HIV submitted to the GLCCM IRB does not contain any information about the screening of donor blood. (30)

Dr. Heimlich defended his actions to FDA by arguing that a) the malariotherapy trial had not one, but two ethical review and approvals, and b) the Great Lakes Association of Clinical Medicine IRB approved the malariotherapy trial based on knowledge that it had local ethical review and approval by officials at the Chinese trial site. Dr. Heimlich asserted to FDA that:

Because of his great respect for the several hundred physician members of GLCCM and their IRB, and to have the benefit of their advice, he sought IRB approval even though it was not required.

And:

The project received independent approval from review boards from municipal, provincial and Ministry of Health authorities, as well as the provincial scientific committee. GLCCM most certainly understood this situation – apparently much better than the FDA investigator. Perhaps the FDA investigator can explain what he means by the Chinese attitudes about the research and why this does not reflect any type of ethnic bias. (4)

Dr. Heimlich's assertion that Great Lakes Association of Clinical Medicine IRB approved the malariotherapy trial with the knowledge that it had local ethical review and approval is flatly contradicted by the IRB: the FDA warning letter of 2000-03-09 objected that the name of the clinical investigator was indicated only by XXXXXX in the IRB records, and in response to the agency's further correspondence, by letter of 2000-05-26, Dr. Chappell (IRB secretary) informed FDA that:

We have requested the name of the Chinese clinical investigator from Dr. Heimlich, to inform the investigator of his responsibility to obtain the appropriate Chinese government and local institutional approval for the research. (5)

It's obvious the IRB did not have knowledge of approval in China as Dr. Heimlich claimed if they didn't know who was conducting the trial.

It's also unclear that the trial had appropriate approvals in China when it first began. Dr. Heimlich and his co-investigators do not indicate that ethical approval was obtained from the appropriate local authorities in Guangzhou in all of their publications: the earliest article is vague; another suggests difficulty in obtaining ethical approval, and it is not until 2003 that publications explicitly state that approval was obtained from the Municipal Department of Health of Guangzhou, the Provincial Department of Health of Guangdong, and the Provincial Committee of Science and Technology of Guangdong, China. The initial publication in 1997 simply reads:

Institutional Review Board approval was obtained for this study. (6)

The investigators' statement in the 1999 article is curious – Dr. Heimlich's protocol approved by the Great Lakes Association of Clinical Medicine IRB would enroll 30 subjects; in China, enrollment was limited to 10:

Through a couple of institutional board discussions, a final approval of phase-1 studies (no more than 10 cases) of malariotherapy for HIV infection conducted in Guangzhou was obtained from the board. (7)

Difficulty in obtaining ethical approval is described several pages later:

A lot of reports have shown that malaria stimulates immune system to produce a variety of immune factors including IL-1, IL-4, IL-6, TNF-α, IFN-α, IFN-γ, IL-2R, and sCD8 and increase of many of these factors is harmful to HIV/AIDS patients (such as promotes HIV replication) based on the data of HIV/AIDS research. This was why many doctors including American and Chinese doctors opposed us when Dr. Henry J. Heimlich first proposed the idea of malariotherapy for HIV/AIDS early in 1992. In a couple of institutional board discussions on this issue, many criticisms came from the board members, and during the time, Dr. Xiaoping Chen proposed a hypothesis to discuss with those who opposed us that all these harmful factors would do (sic) increase during malarial phase based on our previous knowledge on malaria, but after termination of malaria, these factors would sharply recover to baseline, and even to lower than baseline due to a feedback mechanism of immune system. The board finally approved us to treat no more than 10 HIV patients with the therapy in the phase-1 studies. (8)

According to a 1994 article published by the Los Angeles Times:

Heimlich said that the nine HIV-positive patients who have been infected with malarial blood are men in their 20s and 30s who have given informed consent. Our protocols meet all the standards — exceed the standards required in the U.S. I am very strict, he said.

Dr. Heimich's assertion that his induced malariotherapy for HIV/AIDS research conducted in China met or exceeded US requirements is incorrect. The departures from US regulations for the protection of human subjects in Dr. Heimlich's purported informed consent for the study titled A Pilot Study of Induced Malaria Therapy in 30 Human Immunodeficiency Virus Positive Individuals are enumerated at length in the FDA's warning letter to the Great Lakes College of Clinical Medicine IRB. Moreover, Dr. Heimlich submitted his research protocol to an IRB that lacked the legal authority to review or approve it. Finally, Dr. Heimlich and his Chinese co-investigators reported on eight subjects, not nine. What happened to the apparently missing ninth subject? (9)

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Heimlich MicroTrach ™

At first glance, this device should be a non-issue. The Heimlich MicroTrach ™ is simply one of a number of transtracheal oxygen delivery systems on the market. Like nasal cannulae, transtracheal oxygen delivery systems provide oxygen therapy to patients in their homes. Unlike nasal cannulae, transtracheal delivery systems increase treatment compliance, decrease total oxygen gas used, and appear to improve quality of life in appropriately selected patients. (10)

What's problematic about this device isn't whether or not it's safe and effective in appropriately selected patients, but rather the claims made by Dr. Heimlich about the regulatory history of this device. In his biography on the Heimlich Institute Foundation web site, Dr. Heimlich claims that:

In 1980, Dr Heimlich conceived of the Heimlich MicroTrach ™, a tiny tube inserted into the trachea at the base of the neck under local anesthesia. Immediately approved by the Food and Drug Administration, the MicroTrach ™ has many advantages over other methods of oxygen delivery. (11)

This claim is contradicted by information available from the FDA. According to the agency's device information database, the Heimlich MicroTrach was approved for use on November 7, 1989. (12) Less than a year later, an FDA Enforcement Report records that the Heimlich MicroTrach was the subject of a manufacturer-initiated recall prompted by information that the catheter may kink within the trachea. What's more, according to this same enforcement report, the Heimlich MicroTrach, a small gage tracheostomy catheter, was intended to permit administration of low flow oxygen to patients during surgery — this is clearly not the intended use for which the device is currently marketed (continuous or near-continuous home oxygen therapy) nor is it consistent with the uses touted elsewhere by Dr. Heimlich. (13)

At a 1989 conference, Dr. Heimlich described the experimental use of the Heimlich MicroTrach in pediatric subjects with cystic fibrosis as follows:

Cystic Fibrosis

We have treated hundreds of these patients and the procedure is being done around the country and is approved by the FDA. We found that by putting a little saline solution into the Heimlich Micro-Trach, it forces a cough that expels secretions and also loosens the mucus. It seemed logical – logical is the operative factor – that if we used this method in cystic fibrosis (CF), it would clear out the secretions that kill CF patients. Ninety-eight percent of CF children die because of the thick secretions in the lungs, causing infections and destroying the lungs. They die mostly in childhood or adolescence. Some now get to over age twenty. So if you put the Micro-Trach into the CF patient and they squirt a little saline solution through it, it obviously loosens the secretions, which they cough up. In the last year-and-a-half, we have enlisted six cystic fibrosis centers in children's hospital at universities around the United States – and we'll be happy to do it here in Israel, if you wish – and we have been starting to treat these children. What sense would there have been to try to do animal experiments? It was possible to go to the internal review boards (IRB's) of these institutions, which decide whether you can do human experimentation, and they all agreed that we could go ahead and do it. The logic was there. It is possible to convince the people in these clinical areas to proceed with a previously untried procedure, if you can show the logic and can convince them of its importance. The CF program has progressed well enough so that we are now expanding to 5 or 6 more CF centers and by the end of the year, we will have collected enough data – no animal experimentation – enough data to have proved the procedure that is literally turning lives around for these children. (14)

Several of these statements are peculiar or incorrect.

1. We have treated hundreds of these patients and the procedure is being done around the country and is approved by the FDA.

2. It was possible to go to the internal review boards (IRB's) of these institutions, which decide whether you can do 'human experimentation', and they all agreed that we could go ahead and do it.

3. The CF program has progressed well enough so that we are now expanding to 5 or 6 more CF centers and by the end of the year, we will have collected enough data – no animal experimentation – enough data to have proved the procedure that is literally turning lives around for these children.

On April 18, 1984 the Associated Press published an article on Dr. Heimlich titled Heimlich Devises Portable Breathing Device for Lung Disease Victims, ostensibly describing the MicroTrach, which included the following:

In a speech Monday at an Illinois Institute of Technology seminar, Heimlich said patients with emphysema, black lung, pulmonary fibrosis and other debilitating lung diseases already have had the 5 1/2 -inch Teflon tubes inserted into their windpipes.

Heimlich said the device was linked to a portable 6-pound oxygen unit that supplied air for eight hours. This permitted a return to work for patients who previously were almost confined to bed while wearing face masks or nasal tubes attached to large oxygen tanks, he said.

Charles Spurry, 65, a retired resident of suburban Northfield who was one of 88 patients equipped with the tube in a 10-minute procedure at Deaconess Hospital in Cincinnati, said he used his unit on the golf course.

Spurry said his insurance covered most of the $3,500 tube insertion. (15)

Since hospitals do not, as a rule, implant unapproved devices in patients outside of clinical trials, and since insurance companies even today do not regularly reimburse patients for unapproved devices, this report suggests that the MicroTrach device had several iterations or that there were a number of devices to which the same trade name was applied.

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Reversed Gastric Tube Operation

In his biography on the Heimlich Institute web site, Dr. Heimlich credits himself with the development of the Reversed Gastric Tube operation on the esophagus:

In the 1950s, a month after completing training in general and chest surgery, Dr. Heimlich conceived of an operation to replace the esophagus. After successfully performing the procedure, he presented the results at an American Medical Association meeting in 1961. The procedure, dubbed a hot medical discovery by Life Magazine, was the first total organ replacement in history. It is used today to overcome birth defects of the esophagus. (16)

An article appearing in 2003 in the Cincinnati Enquirer, however, offers a radically different version:

For more than 40 years, Cincinnati icon Dr. Henry Heimlich has been taking credit for a world-famous operation that was actually developed first by a Romanian surgeon behind the Iron Curtain.

In interviews, biographies and promotional materials, Heimlich has told anyone who would listen that he performed the world's first total organ replacement.

But even before Heimlich wrote his first article about the Heimlich Operation on dogs in 1955, the procedure had been performed dozens of times on humans by Romanian surgeon Dr. Dan Gavriliu, an Enquirer investigation has found.

Gavriliu now calls Heimlich a liar and a thief. He says Heimlich not only took credit for the operation, but also lied when he said they co-authored a paper for an international surgery conference. (17)

A 1986 article in the Saturday Evening Post provides yet another variant:

The morning mail also brings him a letter from Bucharest, from a doctor he has not seen since 1956, when he traveled to Rumania to exchange information with the only other doctor in the world performing the replacement esophagus operation, in which the lower part of the stomach, which secretes no acid, is sewn or stapled off, then cut free and raised as a tube, with blood supply still intact, to replace the damaged esophagus.

Dr. Heimlich developed the technique during a meeting. It came to him whole and in detail. He knew immediately it would work. Afterward, he scribbled the basic procedure on a napkin for the chief of surgery at Mount Sinai Hospital, and the man ignored it. Undaunted, Dr. Heimlich, then 30 years old, walked down the street to the New York Medical College and wrangled the use of lab space and a $300 grant to test his theory on dogs. Working alone, he could not keep the animals alive through the surgery. Some interns he was teaching helped him out; when a dog finally did survive, he paid the animal custodian $5 for each week he could keep it alive.

He published a paper on the operation, but it was several years before he got a chance to perform it on a human patient. When he did, he altered his technique, and the man died. That, Dr. Heimlich says, is the true test of how much you believe in yourself and your idea. He did not stop. When he got a second chance at another hospital, the operation went smoothly and the patient, previously terminal, recovered. (18)

Res ipsa loquitur.

See also Funding and Sponsorship of Induced Malariotherapy research.

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Notes

1. Correspondence from Henry Heimlich M.D. to Jane Henney M.D., (2000-05-04) p.3 pdf small icon

2. Correspondence from Henry Heimlich M.D. to Jane Henney M.D., (2000-05-04) p.3 pdf small icon

3. Informed consent, Induced Malaria as Therapy for HIV Infection, p. 2 pdf small icon

4. Correspondence from Henry Heimlich M.D. to Jane Henney M.D., (2000-05-04) p.3 pdf small icon

5. FDA Warning Letter to Great Lakes College of Clinical Medicine IRB, L. Terry Chappell, M.D., Secretary (2000-03-09), p.9 pdf small icon; L. Terry Chappell, M.D., Secretary, Great Lakes College of Clinical Medicine IRB, to FDA (2000-05-26), p.2, respectively. pdf small icon

6. 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 web site at: http://web.archive.org/web/20040209070512/www.heimlichinstitute.org/malariohiv.html (page last updated on 2004-02-09; retrieved on 2004-12-31)

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): 225

8. 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

9. Heimlich's Audacious Maneuver, Pamela Warrick, The Los Angeles Times, 1994-10-30. Violations of federal regulations in approval of 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 pdf small icon; Lack of authority of GLCCM IRB to review or approve study titled A Pilot Study of Induced Malaria Therapy in 30 Human Immunodeficiency Virus Positive Individuals: Steven Masiello, FDA/CBER to Henry Heimlich, M.D., in reply to correspondence of 2000-05-04 from Henry J. Heimlich, M.D. to FDA Commissioner Jane Henney, M.D. (2000-06-08) pdf small icon; Number of subjects: 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 web site at: http://web.archive.org/web/20040209070512/www.heimlichinstitute.org/malariohiv.html (page last updated on 2004-02-09; retrieved on 2005-02-05).

10. Transtracheal oxygen delivery systems on the market (not a complete listing):
I. Heimlich MicroTrach ™ (brochure): http://www.heimlichinstitute.org/MicroTrach1.html, and Heimlich Institute Foundation information on the Heimlich MicroTrach http://www.heimlichinstitute.org/microtrach.html. According to a 1998 review article (see the Postgraduate Medicine review article by Weg & Haas below), the Heimlich MicroTrach is (or was) distributed by Life Medical Technologies of Salt Lake City, Utah. Data from the Utah Department of Commerce (Business Entity search online at: https://secure.utah.gov/bes/bes), suggests this Delaware corporation is no longer registered in Utah. The corporation currently does business as Zynex Medical Holdings: http://www.secinfo.com/$/SEC/Registrant.asp?CIK=846475&View=Registrant.
II. Transtracheal Systems Inc.: http://www.transtracheal.com/products/scoop_products.asp.
III. 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 2005-01-02 at: http://www.rcjournal.com/online_resources/cpgs/othefcpg.html ; Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Accessed 2005-01-02 at: http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=5591&string=oxygen; Long-term oxygen therapy for COPD. Improving longevity and quality of life in hypoxemic patients. John G. Weg, Haas, Carl F. Postgraduate Medicine 1998; 103 (4): 143-158. Accessed 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, accessed 2005-01-02 at: http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=240.2&ncd_version=1&basket=ncd%3A240%2E2%3A1%3AHome+Use+of+Oxygen

11. Henry J. Heimlich, M.D., Biography, accessed 2005-01-02 at: http://www.heimlichinstitute.org/bio.html

12. Heimlich MicroTrach ®, Devices@FDA: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=PMN&id=K895130

13. FDA Enforcement Report, 1990-05-29, accessed 2005-01-02 at: http://www.fda.gov/bbs/topics/ENFORCE/ENF00067.html

14. Henry Heimlich, M.D., Without Animals: Advantages and Safety of Clinical Research , From the Proceedings of the First International Medical Conference Against Vivisection; Israel, 1989. Accessed 2005-01-02 at: http://www.animalvoices.org/ADAV/heimlich.htm

15. Heimlich Devises Portable Breathing Device for Lung Disease Victims, AP, 1984-04-18

16. Henry J. Heimlich, M.D., Biography, accessed 2005-01-03 at: http://www.heimlichinstitute.org/bio.html

17. Heimlich falsely claims he invented surgical procedure, Robert Anglen, The Cincinnati Enquirer, 2003-03-16. Accessed 2005-01-03 at: http://www.enquirer.com/editions/2003/03/16/loc_heimlich16.html

18. Dr. Heimlich: The Man Behind the Manoever, Part II, Robert McKay, Saturday Evening Post, December 1986, p. 3. Accessed 2005-01-03 at: http://www.findarticles.com/p/articles/mi_m1189/is_v258/ai_4530957/pg_3

19. Son chokes on Heimlich's career, Dan Monk and Andrea Tortora, Cincinnati Business Courier (2005-01-23) Accessed 2005-02-05 at: http://msnbc.msn.com/id/6860389/

20. 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 (1994-05-27) pdf small icon

21. Chart of Malariotherapy for HIV/AIDS, funding and sponsorship, with following notes. According to the Heimlich Institute Foundation Inc.'s IRS Forms 990, they expended $173,332 on AIDS research and education between 1998 and 2002. Current solicitations for donations on the Heimlich Institute Foundation web site are quoted at this link.

22. Chart with notes, Malariotherapy for HIV/AIDS, funding and sponsorship. Current solicitations for donations on the Heimlich Institute Foundation and Deaconess Associations Inc. web sites are quoted at this link.

23. See Note 21, above.

24. FDA to Great Lakes College of Clinical Medicine IRB, L. Terry Chappell, M.D., Secretary (2000-04-13), p. 9-10 pdf small icon. Extended discussion of ethical deficiencies of study titled A Pilot Study of Induced Malaria Therapy in 30 Human Immunodeficiency Virus Positive Individuals.

25. 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, p. 4 (2000-05-04) pdf small icon

26. Institutional affiliation and title of principal investigator Xiaoping Chen: 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. Accessed 2005-02-05 at: http://www.cma.org.cn/cmj/PDF/2003/2003121810.pdf pdf small icon.
Publications which make no mention of explicit approval by Chinese authorities:
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. Accessed 2005-02-05 at: http://web.archive.org/web/20040209070512/www.heimlichinstitute.org/malariohiv.html.
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. Compare with the explicit statement by Chen et al. in 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 (Engl). 2003 Jul;116(7):1017. Accessed 2005-02-05 at: http://www.cma.org.cn/cmj/PDF/2003/200371016.pdf pdf small icon.

26. Dr. Heimlich's malariotherapy for HIV/AIDS condemned by CDC: 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 small icon. Condemned by expert AIDS researchers: Expert opinions of proposed IMT Study (IMT for HIV/AIDS) accompanying petition sent to federal agencies by Paul Bronston, M.D. Condemned by head of AIDS research at NIH: leading AIDS researcher Dr. Anthony Fauci, who called malaria therapy 'quite dangerous and scientifically unsound' , in Heimlich's Audacious Maneuver, Pamela Warrick, The Los Angeles Times, 1994-10-30. Condemned by leaders of US consumer protection organizations: Lurie, P. and S. Wolfe. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med. 1997;337(12):853-6. Robert Baratz, M.D., Ph.D., Son chokes on Heimlich's career, Dan Monk and Andrea Tortora, Cincinnati Business Courier (2005-01-23). Condemned by research protection advocacy groups: CIRCARE (self-evidently); Association for Human Research Protection, Infomail of 2003-04-17.

27. Deficiencies in informed consent for study titled Induced Malaria as Therapy for HIV, FDA Warning Letter to Great Lakes College of Clinical Medicine IRB, L. Terry Chappell, M.D., Secretary (2000-03-09), pp. 9–10 pdf small icon

28. Civil, criminal, and administrative actions against GLCCM IRB members and researchers (not a complete listing).

29. Correspondence from Henry Heimlich M.D. to Jane Henney M.D., (2000-05-04) p.1 pdf small icon

30. Informed consent for study titled Induced Malaria as Therapy for HIV pdf small icon

31. 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., in 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. Accessed 2005-02-05 at: http://web.archive.org/web/20040209070512/www.heimlichinstitute.org/malariohiv.html. Number of people diagnosed with AIDS in Guangdong province in 1995: 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). Accessed 2005-02-05 at: http://www.csu.med.cuhk.edu.hk/hkaids/research/a10.htm.

32. The following studies were terminated. Dr. Heimlich's study S043 Induced Malaria Therapy was terminated by the FDA request in the letter to the IRB of April 13th: GLCCM IRB Meeting Minutes, p.1 (2000-05-05) pdf small icon

33. Continuing Review/Updates … Dr. Heimlich's study S043 Induced Malaria Therapy … The treated HIV patients in this study are still doing well. The exception of not including the Patient Bill of Rights due to complications of the data being collected in China, and a request to submit data to the IRB, the motion to approve Dr. Heimlich's study S043 Induced Malaria Therapy … was given at significant risk with approval until September 16, 2000 by John Trowbridge and 2nd by Tim Guilford. The vote was 11-0 in favor: GLCCM IRB Meeting Minutes, p.2 (2000-02-25) (Emphasis original, and inaccurate. The GLCCM IRB was under the erroneous impression that all proposed research had to be assessed like Class III device studies: significant risk (SR) and non-significant risk (NSR) designations apply only to device studies – not to drugs or malaria parasites.) pdf small icon

34. Rules, Institutional Review Board, Great Lakes College of Clinical Medicine: No.8 When approved, you are required to submit a continuing review in writing two weeks prior to the expiration date. Any study exceeding one year without approval will be terminated. (Revision of 1/00; emphasis original) pdf small icon

35. Malarial Treatment for Chinese AIDS Patients Prompts Inquiry in U.S., Donald G. McNeil, Jr., The New York Times, 2003-03-04

36. Correspondence from Henry Heimlich M.D. to Jane Henney M.D., (2000-05-04) p.1 pdf small icon; Informed consent, Induced Malaria as Therapy for HIV Infection, p. 4 pdf small icon


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Last Updated: 2007-04-01

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