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Monday, September 18, 2006
Victoria’s Secret: Politics, Opinion, and Science Collide at the Heimlich Institute
Posted by The Dean of Cincinnati
Faced with growing concern about her failure to inform authorities about illicit research being carried out through the Heimlich Institute, congressional candidate Victoria Wells Wulsin has finally released the report itself after weeks of promising it to this forum.
The report however has been changed by the insertion of an “after the fact” Executive Summary. The original report had no such summary. Normally an Executive Summary condenses the report into a précis for the busy reader. The purported Executive Summary put forward by Wulsin is a selected extract of the few parts of the report which are critical of “Malariotherapy” slanted in a way to make it appear that Wulsin was critical of Heimlich’s work in this area. Missing from the Executive Summary are examples of how Wulsin suggested that work continue, expand, and be renamed.
Wulsin’s changing of the report by seemingly adding the summary as if it were there all along is akin to a doctor modifying a medical record after the fact, an illegal and unethical act.
Robert Baratz, MD, PhD, DDS, President of the National Council Against Health Fraud, has written an overview of the Malariotherapy work at the Heimlich Institute and Wulsin’s role in it. His comments appear below, followed by a link to the Wulsin report. The Beacon has an unedited version of the original report which confirms these findings.
###
The world of politics is quite different from the world of science. Science is driven by data, politics by the public’s opinions of a candidate. Real scientists rest their careers on a search for the truth—following rules of ethical conduct, and carefully drawn experiments. Politicians fill their sails, and their lungs, with the prevailing winds of public interest, fears, and opinion, hoping to ride these winds into office, and stay there.
We expect our scientists to be honest, accurate, and dedicated to finding the truth. Our expectations of politicians may start that way, but the reality is often different.
Enter the Heimlich Institute, now essentially a one-person show with a checkered history. Its head, body and tail is Henry Heimlich, former chief of surgery at the Jewish Hospital, having left there at the height of his career under cloudy circumstances. The Institute has been a platform for Heimlich for the past 30 years. After gaining notoriety in 1974 for promoting abdominal thrusting for those who aspirated solid objects, Heimlich has since relentlessly tried to push this method for treatment of drowning and asthma, where it is inappropriate and dangerous. The Heimlich Institute was his pulpit and a filter for fund-raising.
Stripped of homey talk, a presence, and the gift for gab, the essence of what has come from the Heimlich Institute for the past 30 years has been Henry Heimlich’s opinion. When asked repeatedly for data to support his claims there have been none, or merely a series of unsupported anecdotes, coupled with his strong personality.
While abdominal thrusting for choking has been Heimlich’s holy grail, even that has recently been found wanting by the American Heart Association and the Red Cross. More effective chest thrusts were demonstrated convincingly by Charles Guildner, an anesthesiologist, as early as 1976. Instead of embracing the data, and coalescing it with his method, Heimlich attacked Guildner, suggesting his work was unethical. Guildner was put under the gun for several years until vindicated by medical authorities. Guildner’s work has been confirmed by other medical scientists and fits the anatomy and physiology of choking. In contrast, Heimlich’s mantra seems to be: “My way is the only way.” Not quite the stuff of which science is made.
The Heimlich Institute has moved around. It was, for a time, headquartered at Xavier University, but departed under a cloud. For a time it was unaffiliated, but since 1998 has been a part of Deaconess Associations. Its fund-raising and money are murky. There are repeated rumors of off-shore accounts, double sets of books and other clandestine activities. But they are not the subject of this piece, and so will be left for discussion on another day.
Beyond abdominal thrusting Henry Heimlich’s other holy grail has been “Malariotherapy” - injecting malaria into people deliberately to “treat” cancer, Lyme disease, and, most recently, HIV infection. Malaria is caused by a small, single-celled animal called a protozoan. Amoebae are also protozoans. The malarial parasite lives within red blood cells and circulates around the body. Red cells last 100 days and when they are worn out the parasites may be released. Also, when it is time to replicate, the organisms do so in concert in multiple cells, bursting the cells and releasing a “bloom” of parasites into the blood stream. When this happens high fevers occur and the infected individual becomes quite ill. Malaria is spread when a mosquito ingests a “blood meal” and then passes the parasites on to another individual. Standard antibiotics do not work with protozoans. There are highly effective medications to treat malaria in all of its varieties, quickly and at low cost.
Cancer is a disease of abnormal cells growing abnormally. There are many types of cancer, each different. Cancer can be a fatal disease and the word raises fear among those with this diagnosis. Prevention, or in its place, early detection and proper treatment, often leads to successful outcomes. As with many unwanted and serious diseases victims are often desperate, and prey for quacks. A consistent method of cancer quacks has been “elevated temperature treatments.” In some test-tube settings cancer-like cells are heat sensitive. The quacks generalized this to all cancers claiming that high-heat therapy can kill off the cancer. What better way to do this than by inducing a fever? From this leap-frog logic, “Malariotherapy” was born.
[I note that very recent cancer treatment experiments with hyperthermia are quite different and involve specific agents and specific types of cancer.]
There are references to cancer treatments sponsored by Heimlich, some abroad. Not to be dissuaded by negative outcomes, and intense criticism, Heimlich switched his emphasis to Lyme disease, a bacterial illness easily treated by common antibiotics. Here too “Malariotherapy” was promoted and used. When this was also put under scrutiny by authorities and medical groups, Heimlich switched to using “Malariotherapy” for HIV infection. More recently the idea of hyperthermia was discarded and now “immune” boosting, another tenant of quackery, was put forward to justify the “Malariotherapy”.
Good science builds on prior discoveries. Good science starts with known facts, and then shows, via a pilot experiment with an animal or cell culture model that the idea might work. Thereafter a number of animal and other preliminary studies are done before any notion of human experiments is entertained. These precepts seem foreign to the Heimlich Institute where “fire, ready, aim” seems to be the sequence. We’re asked to accept this approach since Henry Heimlich is a maverick and has been “right before.” “Right about what?” seems a reasonable question.
As previously reported on these pages, in the mid 1990s Heimlich was told in no uncertain terms that his ideas about “Malariotherapy” were unsupported by science by various government health officials, scientists and others. Instead of collecting data in animal and similar experiments to prove his speculations, Heimlich continued to work clandestinely on humans. See CIRCARE’s website for a lengthy and annotated review on this topic.
Heimlich has contended that his work was endorsed and approved by Institutional Review Boards for Human Experimentation (IRB’s). No quite so. The IRB which allegedly approved Heimlich’s work was told to suspend operations in 2000 and shut down a year later. Heimlich’s work was singled out as non-conforming to rules and regulations. Claims were later made that the work was “foreign” (done in China) and not subject to US FDA scrutiny. Initial denials were made of involvement of US institutions, or work on US soil. Not so again. Heimlich’s spokesperson Robert Kraft of Dan Pinger’s PR Agency claimed that Heimlich had stopped this work. Not so again according to a recent article in Radar Magazine (also reported here). While the FDA was investigating Heimlich in 1999 and 2000, and claims of no US involvement were being made, Heimlich had penned the following to comedienne Phyllis Diller, one of his financial suppoters, showing that UCLA involvement went back to 1996, and that UCLA personnel were active participants, placing the matter under FDA aegis.
From a handwritten letter to actress Phyllis Diller, July 13, 1999, offered for sale on EBay.
I have enclosed some material concerning the Malariotherapy for AIDS research. The results have been so effective that in 1996 UCLA asked to join me and now carry out the lab work and send their professor to China regularly. We have been invited to treat many patients in Africa and are arranging to do so. And you were there in the beginning!
All my love,
Henry Heimlich
Enter Victoria Wells Wulsin, MD, epidemiologist, and present congressional candidate, who began work in the second half of 2004 for the Heimlich Institute. As reported here Dr. Wulsin was courted as a potential successor to Dr. Heimlich for the leadership of the Heimlich Institute. She was apparently paid tens of thousands of dollars as a consultant to write a report on “Malariotherapy” for the “board” of the Institute. Mind you this was after all of the reports and correspondence on “Malariotherapy” with the CDC, FDA, and others. This was after all of the press on this subject in the LA Times, NY Times, UCLA Bruin, and other newspapers, including the Cincinnati Enquirer. See the CIRCARE compilation.
Yet, despite all of this, Dr. Wulsin, who was shown fresh data that indicated “Malariotherapy” experiments were still going on as she did her review, and even remarked on those data, never blew the whistle on Heimlich or the Institute that experiments were still going on. Henry Heimlich was “uninvited” from the Pan Africa AIDS Conference over this very issue on October 30, 2004 at the height of Wulsin’s consultancy. Yet this too seemed to escape her notice.
She told one reporter that she did not find “Malariotherapy” effective, yet in her report to the Heimlich Institute she laid out plans to rename it, promote it, and do further research on it. She claimed that she was “fired” the day after the draft of her report was submitted. If the report was positive, as it was, then why was she fired?
My read of the report is, of course, my opinion, and you should read it and judge for yourself what she says.
Space and focus does not permit a full analysis of the flaws of the Wulsin report. What I see is an uncritical naive review, leaving out much of the science on this subject, especially the science that shows that co-infection with HIV and Malaria can make things significantly worse. Infection with malaria of someone with a compromised immune system with deficient T cells (needed to fight parasitic, protozoan infections) can make the malaria even worse than it normally would be, and also cause the HIV to accelerate as more T cells are generated and can thus get infected by the HIV. Heimlich (and Wulsin) have made notice that T cell counts rise slightly after infection with malaria. Maybe so, but the small numbers of subjects are not enough to be convincing. But, even if the rise is real, it is temporary, may represent normal variation, and does not affect the progression or intensity of HIV.
What I found most peculiar and troubling about Dr. Wulsin’s report for the Heimlich Institute was her apparent endorsement of what they were doing, continuing the “Malariotherapy” experiments. (Read the whole report and see for yourself.) The mysterious “sponsors” of the current African research and the details thereof should have absolutely been part of her review.
Dr. Wulsin now seeks the office of congresswoman, representing the citizens of Ohio. While we all can make small errors of judgment and may disagree from time to time, Wulsin’s activities at the Heimlich Institute go beyond simple mistakes. She knew exactly what she was doing, worked for a period of months, had access to records and resources, and was paid for it. How she was paid should be the subject of further investigation. In my opinion, her failure to stop the “Malariotherapy” by exposing it is reprehensible. If she claims she didn’t know then she is inept. Heimlich’s own spokesperson, Kraft, had proclaimed the work had stopped. It clearly had not. “Was Kraft lying?” is also a question to ask.
Any way you slice it Wulsin’s actions or lack of actions are not endorsements for a seat in Congress. If she wants to do some good for the citizens of Ohio she should reveal all she knows.
Enter Phil Heimlich, local politician as Hamilton County Commissioner, and Board Member of the Heimlich Institute. Money for “Malariotherapy” was listed for years, and even recent years, in the tax returns of the Heimlich Institute. Dr. Wulsin’s consultancy was to give a report to the Board and regular updates were given. Where was the Board of the Heimlich Institute for the past decade while the “Malariotherapy” was being done, largely on prisoners in China and poor Africans, both of which were deprived of effective HIV therapy for a unsupported, inane, unjustified trial of a dangerous and ineffective treatment on Third World Subjects.
The Heimlich Institute is quite a place, as are its associates.
Phil Heimlich and Victoria Wells Wulsin are both running for elective office this November. The voters should determine what kinds of people they want to represent them. The above does not ring well for either.
The Heimlich Institute should be closed. My mother, who has a few years on Henry Heimlich, is constantly taking courses to continue to learn and renew herself. Perhaps Henry would consider some in medical ethics and research methodology as the doors shut behind him and he reflects on his life and what he has done.
Robert S. Baratz, MD, PhD, DDS
President, National Council Against Health Fraud
Peabody, Massachusetts
Immunotherapy and Beyond by Victoria Wells Wulsin MD, PhD, December 2004. Note: the undated first page entitled “Executive Summary” was not part of Wulsin’s original report, but appears to have been written recently.
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18 Sep 2006 at 06:42 am | #
She knew exactly what she was doing, worked for a period of months, had access to records and resources, and was paid for it. How she was paid should be the subject of further investigation. In my opinion, her failure to stop the “Malariotherapy” by exposing it is reprehensible. If she claims she didn’t know then she is inept.
The situation is comparable to a reputable historian being paid to write a paper denying the Holocaust. By taking Heimlich’s money to write the report, Dr. Wulsin has ruined her own reputation.
18 Sep 2006 at 07:53 am | #
When Jason, my main phony man, doesn’t like the comments he gets for his distorted views, he simply rehashes the same rhetoric and links around the unfavorable comments:
For the record an attorney, instructor already set the record straight:
komarek says:
18 Sep 2006 at 01:35 am | #
Dean,
I just read the report, and there is no news damaging to Wulsin in it.
My previous comments stand. Regarding the East African research—these were not studies where white-coated researchers injected hapless victims with malaria. These were 8 individual cases where people acquired their malaria cases “naturally,” that is, through mosquito bites. The eight patients, facing an AIDS death sentence, were being treated for their malaria. They did consent to delaying the start of antimalarial treatment “for at least two weeks.” See page 9 of the original report (page 11 of the pdf file).
Of course these infections and the delays in treatment all happened before Wulsin became involved in reporting on this subject.
Wulsin’s report says that further work can’t continue until these original 8 cases are followed longer, and until the case studies are published, verified and elaborated. Contrary to your claims, Wulsin does not suggest, condone or sanction further malarial infections or delays in treating malarial infections. See her timeline on page 16 of the report (page 18 on the pdf file I downloaded):
“2005 - 18-24 month follow-up on pilot series of 8 patients concludes with extremely positive results.
“2006 - East African Phase II Clinical trial is published and/or presented and received with enlightened enthusiasm.
“2006 - East African investigator/s and the Heimlich Institute attain IRB approvals.
“2006 - East African Phase II Clinical trial is published and presented and received with guarded interest.”
Wulsin’s report is, of course, dated December 2004, well in advance of any of this anticipated activity.
Note that Wulsin also recommends that any further clinical trials obtain approval of institutional review boards not just in Africa, but also from those in “donor nations.”
Here is what she says:
“Research in Third World countries, notably in Africa, has notoriously neglected sanctions from operational (usually local) and supporting/donor (often First World) institutions through IRB approval. Given the discrepancy in standard of care between the First and Third Worlds, clinical trials should be conducted only with approval from both local and donor IRBs.” This is from page 13 of the pdf file, page 11 of the original report.
You can see that Wulsin is expressing the same concern you and others have about the ethics of conducting medical research in third-world nations.
Dean, your criticisms of Wulsin with respect to this matter are just wrong.
--pk---
Why would Jason, my main phony man, attempt to conceal comments concerning this matter. The home page refers the public to:
Previous: Ethically Challenged, Part Two: Looking for Wulsin’s Silver Lining—Comments (31)
However: the most recent comments on the topic is:
Wulsin Pressured Into Press Statement by The Cincinnati Beacon? (Ethically Challenged, Part Three)
Sunday, September 17, 2006
The public can see the “true colors”.
Pathetic !
18 Sep 2006 at 08:05 am | #
When a philosophical, medical dentist, whose name to fame is advising the public that weight loss treatments may not live up to their claims, then becomes political analyst :
BUYER BEWARE !
18 Sep 2006 at 09:15 am | #
Dean:
Again you offer up complaints about Dr. Heimlich!
Wulsin clearly had no role in, and has no blame for, Dr. Heimlich’s medical failures.
Those who wish to be informed about Wulsin’s role should read the whole report.
Wulsin never participated in experimentation re: malaria. She told Heimlich that the ongoing 2004 human trials—involving 8 people who were in fact already being given standard medical treatment for malaria they caught through mosquito bites—must be published, verified, and scrutinized, before any further clinical trials could be justified.
Even then, she said further clinical trials should not go forward unless multiple Institutional Review Boards reviewed all the evidence and gave the go-ahead.
--pk---
18 Sep 2006 at 01:13 pm | #
komarek, I’d welcome your answers to the following questions.
It’s been almost two years since Wulsin says she stopped working for the Heimlich Institute. She’s had plenty of time to report Heimlich to oversight agencies for engaging in ongoing unethical human subjects research which continues to put vulnerable, impoverished Africans at risk, yet there’s no indication that she ever did. (It’s fair to assume if she did, she’d have touted that in her materials.)
1. Do you think Wulsin has an ethical obligation to report these violations?
2. Why do you think she has failed to do so?
3. Would you be willing to write her and ask these same questions? If not, why not?
18 Sep 2006 at 02:12 pm | #
komarek wrote:
You keep missing the crux of the entire issue. Firstly, she says she found that malariotherapy has no scientific validity. Why would she advocate for more experiments—with or without IRB approval—if that is the case? When she took this gig, malariotherapy had already been discredited by institutions like the WHO. But still, she wants to rename it to avoid bad press, and contact Michele Ashby of the Denver Gold group. Why?
You keep focusing on those parts of the report that make her look ethical—while ignoring the rest. In my second article on this topic (Looking for Wulsin’s Silver Lining), I tried to look at both sides. I have recognized that she called for more oversight, etc. But how exactly that matches these other components should give us pause.
On all your comments, you continually neglect these other aspects of the report. Why do you do that?
18 Sep 2006 at 02:15 pm | #
Also, on another strand (that got hijacked by Freedom Fighter’s drivel) komarek made a thoughtful rebuttal. I had lost track of it. Here it is:
18 Sep 2006 at 05:10 pm | #
[Editor’s note: FF, your comment has been moved here.]
18 Sep 2006 at 08:42 pm | #
Dean
Thanks for thinking of my comments as “thoughtful.”
I really don’t think your claim, that Wulsin had an ethical obligation to report the malaria experiments, is justified. Wulsin presents the ongoing trial as one which had problems, but not one which appears plainly abusive. The East African trial had results that were at least in part, successful in reducing HIV loads in some of the 8 patients. None of these patients had been infected by clinicians. She does note an assortment of problems in interpreting the results. She also notes that the patients consented to participating in these trials. She reported that the patients needed to be followed for a longer period of time in order to learn their ultimate outcomes.
It’s only fair to take Wulsin at her word that, if she were retained to continue investigating the practice, that no one else would have become infected with malaria in the name of the Heimlich Institute unless and until those eight East African case studies were published, reviewed, and verified. IRB approvals would have been obtained before proceeding. Wulsin certainly did not attempt to make a case for malariotherapy before an IRB. That’s because she stopped working for Heimlich after making her report.
I really don’t think you’re suggesting that Wulsin was required to monitor Heimlich’s work after her contract was terminated!
I do understand that Wulsin expresses less outrage about Dr. Heimlich than you do.
I just don’t think that this is a problem for her candidacy.
--pk---
18 Sep 2006 at 08:43 pm | #
Nice title.
19 Sep 2006 at 03:50 am | #
Well, though thoughtful, there is one thing, komarek, you avoid—the one question I keep posing.
Wulsin wrote:
You wrote:
I am taking Wulsin at her word. While elaborating on the East Africa Phase II trial, she wanted to rename malariotherapy to avoid bad press, and she wanted to contact Michele Ashby of the Denver Gold Group. Reestablishing contacting with the abused mining workers is highly suspect, given how Wulsin would have us believe her position is that malariotherapy has no scientific validity.
19 Sep 2006 at 06:01 am | #
komarek: Wulsin presents the ongoing trial as one which had problems, but not one which appears plainly abusive.
Had problems? Not abusive?
1) From the Radar article:
Mekbib Wondewossen is an Ethiopian immigrant who makes his living renting out cars in the San Francisco area, but in his spare time he works for Dr. Heimlich, doing everything from “recruiting the patients to working with the doctors here and there and everywhere,” Wondewossen says. The two countries he names are Ethiopia and the small equatorial nation of Gabon, on Africa’s west coast.
“The Heimlich Institute is part of the work there — the main people, actually, in the research,” Wondewossen says. “They’re the ones who consult with us on everything. They tell us what to do.”
Wondewossen says that the project does not involve syringes full of malaria parasites. “We never induce the malaria,” he says. “We go to an epidemic area where there is a lot of malaria, and then we look for patients that have HIV too. We find commercial sex workers or people who play around in that area.” Such people are high-risk for HIV, and numerous studies show the virus makes its victims more vulnerable to malaria.
A key to containing malaria is speedy treatment. In the most resource-poor areas, clinicians who lack the equipment necessary for diagnosing malaria will engage in presumptive treatment at the first signs of fever. This, says Wondewossen, runs contrary to Heimlich’s interests. What physicians in Africa usually do “is terminate the malaria quickly when someone gets sick,” he says. “But now we ask them to prolong it, and when we ask them to do that, the difference is very, very big.”
Untreated malaria is horrible and includes periods of 105-degree fever, excessive sweating followed by chills and uncontrollable shivering, blinding headaches, vomiting, body aches, anemia, and even dementia. Heimlich’s malariotherapy literature recommends the patient go two to four weeks without treatment. Delay in treatment, warns the CDC, is a leading cause of death.
Wondewossen say that the researchers involved in the study are not doctors. He refuses to name members of the research team, because he says it would get them into trouble with the local authorities. “The government over there is a bad government,” he says. “They can make you disappear.”
2) Withholding conventional medical treatment from patients is a fundamental violation of human subjects protection law.
komarek is untroubled by Wulsin’s conduct. Others, including medical oversight agencies, may not agree.
19 Sep 2006 at 07:30 am | #
komarek: It’s only fair to take Wulsin at her word
Why? She’s repeatedly lied, changed her story, and only released the report when the Dean was about to get it out first.
The only reason she released the report is because last week Howard Dean and Chris Redfern were informed that the Beacon was about to post it. The party wanted her to get out in front of that and made her do it in hopes of controlling the message. That’s why she added the Executive Summary - to soften the blow. As Dr. Baratz explains, making the Executive Summary appear to be part of the original report was an intentional attempt to mislead.
Don’t believe me? Ask Wulsin.
Again, why take Wulsin at her word? If she was running as a Republican, her relentless defenders here would be equally relentless criticizing her disgraceful participation in the Heimlich trials, meanwhile pocketing $10,000/month.
Since Wulsin now finds so much fault with “malariotherapy” and her former employer, when does she intend to return all that ill-gotten loot to Henry Heimlich, money which came not from the Heimlich Institute but from his personal account at Johnson Investments?
Don’t believe me? Ask Wulsin. Or ask Tim Johnson to deny it.
19 Sep 2006 at 08:15 am | #
Dean -
Item by item:
1. Write a strategic plan for the Heimlich Institute.
Comment: This is not a problem.
2. Rename malariotherapy “Immunotherapy” ["IT"].
Comment: Not a problem. Reason: If the procedure would have proven itself out with the publication of the clinical trials as she recommends (see my prior remarks) the name change could not be objectionable. She certainly isn’t advocating hiding any clinical evidence regarding the practice itself!
3. Verify and elaborate on East Africa Phase II trial.
Comment: This is the proper thing to do. See my prior posts.
4. Explore further collaborating with Michele Ashby, the Denver Gold Group, and/or the CEOs, medical directors, &/or others of appropriate mining companies.
Comment: I think “explore” in the context of Wulsin’s report means “talk about, evaluate, review, consider” --not “buy into whatever they are doing or have done in the past.” Throughout her report, Wulsin focuses on ethical paths to take. “Exploring” as a “programmatic next step” is certainly not an endorsement of anyone else’s actions. This “next step” does not advocate taking any unethical actions in the future.
5. Complete and publish review of Immunotherapy.
Comment: Writing up the existing studies is the proper thing to do. She recommends putting the evidence in the public record so it can be evaluated.
--pk---
19 Sep 2006 at 02:53 pm | #
komarek continues to walk around the dead elephant which is that Heimlich’s “malariotherapy” is so radioactive that UCLA had to discipline faculty who were associated with Heimlich in China. Wulsin knew all that when she got involved with him a year later. komarek can make all the excuses he wants for Wulsin, but that won’t repair her reputation.
Meanwhile, the various Henry Heimlich medical fraud stories continue to develop. komarek’s time might better be spent saying prayers that reporters stay away from this one.
19 Sep 2006 at 03:07 pm | #
Here’s your chance people:
Jim Wallis and leaders of The Amos Project for a public meeting and candidate forum:
Oct 2nd, 2006
7-9 p.m.
At the Cintas Center at Xavier University, Cincinnati, Ohio
Invited candidates:
For Governor
Kenneth Blackwell
Ted Strickland
For U.S. Senate
Sherrod Brown – confirmed
Mike DeWine
For U.S. Congress District 1
Steve Chabot
John Cranley – confirmed
For U.S. Congress District 2
Jean Schmidt
Victoria Wells Wulsin
For Hamilton County Commissioner
Phil Heimlich - confirmed
David Pepper – confirmed