Friday, September 15, 2006
Posted by The Dean of Cincinnati
 Previously, I reported how Dr. Vic Wulsin’s so-called “literature review” on malariotherapy for the Heimlich Institute actually reads like a fundraising prospectus. In this report—which she says got her fired after claiming that malariotherapy has no scientific validity—Wulsin attempts to make ethical claims. However, what kind of a doctor makes ethical statements while promoting the advancement of research deemed vacant of validity? Is Dr. Vic Wulsin ethically challenged? Should ethically challenged candidates serve in public office?
If anyone has questions about how Wulsin addresses her role in malariotherapy experiments, just check out this video excerpt on YouTube. She says the following:
So as an epidemiologist I was asked to study it [malariotherapy]. I did a literature review, and determined that there was not evidence to show that it was effective or helpful. This was disappointing to Hank Heimlich who, of course, wanted to pursue it. So, I gave my report, and my consultancy ended the next day. And we remain respectful friends, but it’s not something that I think has any scientific validity.
So let’s recap—just in the interest of clarity: Wulsin says (1) She determined there was no evidence to show that malariotherapy was effective or helpful, (2) Malariotherapy has no scientific validity.
In her report to the Heimlich Institute, Wulsin includes some statements which would seem—upon a cursory examination—to indicate that she wanted to do the right thing. However, when compared with other excerpts from the same report, it appears Dr. Wulsin is ethically challenged.
She wrote:
V. Ethics
“First, do no harm,” is a fundamental sine qua non of medical training. Not surprisingly, Immunotherapy has received sporadic, but not inconsequential, criticism from the medical establishment as well as others. Institutional review boards (IRBs) at research establishments serve the purpose of protecting patients from over-zealous scientists who might, with the best possible intentions, nevertheless unnecessarily expose vulnerable and disempowered patients to risky and potentially life-damaging or life-shortening treatments, procedures, and interventions. “Informed consent” from study subjects is a necessary but insufficient component of accepted clinical research.
The political atmosphere surrounding HIV/AIDS patients is particularly sensitive, in large part due to a) the terminal nature of the disease; b) the societally-censured major modes of
transmission (sex and injecting drug use); c) its higher prevalence among marginalized groups such as homosexuals, persons of color, Africans, and commercial sex workers; and d) controversy and the perception of inconsistent or inadequate measures to stop its spread.
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.
The proceeding paragraphs strike me as hypocritical indeed. The first study in China suffered from egregious ethical and regulatory lapses, among which were failure to obtain IRB review and approval, as well as failure to obtain informed consent. Wulsin demonstrates an awareness of the need to consider how best to protect vulnerable groups of subjects, as well as issues of marginalization involved in HIV and drug use. Yet she fails or refuses to pass judgment on the obvious: the majority of subjects in both Chinese studies were likely prisoners.
The articles in her literature review note that the most subjects contracted HIV through IV drug use; IV drug use is a crime in China, and HIV infected addicts are traditionally first identified upon being imprisoned. For more on this topic see: Locked Doors: The Human Rights of People Living with HIV/AIDS in China. Human Rights Watch. August, 2003. Available here.
Notice that Wulsin never calls for experiments on any US citizens. If she really were concerned about ethical medical practices, why not explore options here at home and not the third world? But if Wulsin is ethically challenged, that would explain why she includes suggestions like this at the end of her report:
Programmatic Next Steps
1. Write a strategic plan for the Heimlich Institute.
2. Rename malariotherapy “Immunotherapy” ["IT"].
3. Verify and elaborate on East Africa Phase II trial.
4. Explore further collaborating with Michele Ashby, the Denver Gold Group, and/or the CEOs, medical directors, &/or others of appropriate mining companies.
5. Complete and publish review of Immunotherapy.
Despite giving lip service to the vulnerability of certain groups of research subjects, Wulsin proposes the Heimlich Institute pursue malariotherapy research for HIV with mine owners in South Africa. I can scarcely imagine a more vulnerable subject population than miners who are effectively indentured servants living in remote areas. Nowhere does Wulsin suggest malariotherapy be conducted on U.S. citizens.
Elsewhere in her report, Wulsin concludes “The preponderance of evidence indicates that neither malaria nor Immunotherapy will cure HIV/AIDS,” and that data from both Chinese and African trials are “erratic.” So what should we make of her “Programmatic Next Steps”?
Renaming malariotherapy “immunotherapy” will not overcome its stigma, the absence of confirmatory data, or the unethical lapses in human subject protections; that Wulsin concludes the Heimlich Institute should do this suggests her complicity in an effort to conceal unethical research practices by obfuscation.
And what is going on with the reference to Michele Ashby, of the Denver Gold Group? Wulsin purported to elaborate on the issues of research in developing nations and with subjects who are effectively “captives.” Why then would she suggest pursuing conditions highly conducive to unethical practices?
Check out this excerpt from an article by Tom Francis in Radar Magazine:
In particular Heimlich targeted South African gold mines, which employ a large population of poor, AIDS-ravaged miners who live in prison camp–like conditions. Wulsin told me that over the last several years Heimlich has sought to convince South African gold mining companies of the merits of malariotherapy, in the hope that they would allow him to conduct clinical trials on the miners, many of whom are HIV-positive. Wulsin was to have a role in this effort. She says that in 2002 the gold mines sent doctors to visit Heimlich in Cincinnati to discuss the prospects for a study, but the talks eventually broke down over disagreements over who would pay for what. According to Wulsin, Michele Ashby—then the chief executive of Denver Gold Group, an international consortium of gold mines—was acting as a broker between Heimlich and the mines. Wulsin’s report notes that Heimlich spoke at the Mining Investment Forum in 2002, in Denver, where Ashby introduced him to “12 CEOs who operate in South Africa and other locations.” When I called to ask Ashby about her role in malariotherapy, she hung up on me.
While Francis goes on to claim that Wulsin’s report “proposes significant upgrades in safeguards, oversight, and accountability before moving forward,” he is simply quiet on the degree to which her proposals for upgrades contradict her plan for further research. He does, however, note the following: “Wulsin even suggests changing the name ‘malariotherapy’ to ‘immunotherapy,’ suggesting that the very treatment itself was tainted.” In an article about Henry Heimlich, it may have been out of Francis’ scope to take on Wulsin. But that line signals a lack of internal consistency concerning Wulsin’s report—which The Cincinnati Beacon obtained from Dr. Robert Baratz, President of the National Council Against Health Fraud.
Here is another extensive quotation from the report. Notice how Wulsin advocates for continued investigation into malariotherapy, though she states elsewhere that it doesn’t work. What kind of senselessness is this?
IX. Conclusion
Immunotherapy: Past, Present, Future
Immunotherapy claims a fascinating history of effectiveness for another largely sexually transmitted epidemic. Its safety was demonstrated over much of the twentieth century, precluding the necessity of Phase I clinical trials for replicating its use for HIV. Phase II clinical trials have resulted in positive, though discrepant, results in 20 Chinese and 8 East African HIV-positive individuals. Currently the Heimlich Institute has no formal association with either of these trials, although the sponsor of the East African work maintains contact with the Heimlich Institute and shares results regularly. No written protocol is available for this innovative work in which patients acquire malaria naturally and are followed thereafter.
Further field studies of Immunotherapy, including Phase III and IV clinical trials, require the verification of the encouraging results from East Africa, elaboration on discrepancies between them and the results from the Phase II trial in China, and professional dissemination and transparent discussion with scientists, physicians, and other stakeholders.
The Heimlich Institute: Strengths, Weaknesses, Opportunities, Threats
A summary of the strengths, weaknesses, opportunities, and threats ("SWOT") of the Heimlich Institute can open the door for a more detailed, relevant, and exhaustive analysis to guide its strategic, operational, and administrative plans. The strengths of the Heimlich Institute center on Dr. Heimlich himself: his brilliance, his creativity, his passion, his reputation, and his development of the Heimlich Maneuver that has saved thousands, if not millions, of lives. Dr. Heimlich does not shy away from controversy and has improved the world on account of his courage and persistence. He has constructed a strong, independent Board of Directors and
established a working relationship with a multi-million-dollar non-profit institution, the Deaconess Associations Incorporated.
Looks like Wulsin is trying to ride the fence on this one—though such equivocation is the hallmark of a mediocre politician and not an ethical doctor. In some places, she acknowledges the need for more institutional oversight and the fact that research indicates malariotherapy is not effective. Then, she turns around, calling for more data and more collaboration with slave-like laborers in African gold mines. And in the excerpt above, she shifts from advocating more elaboration on East African and Chinese data, to a glowing and gushing ego-stroke of her boss, Dr. Henry Heimlich. (Remember, Wulsin hoped to take over as Heimlich’s successor to the Institute.)
These inconsistencies are troubling. Dr. Vic Wulsin appears to be ethically challenged, flip-flopping from page to page in her report. However, no matter the silver linings we can find along the way, the bottom line is that—at the end of her report—Wulsin advocated for more research concerning something she finds scientifically invalid, and she pushed to re-establish contact with gold mining companies that could provide access to third-world slave-like laborers.
And this is someone the Democrats herald as a progressive? Looks like Wulsin isn’t the only ethically challenged person out there.
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Read ”Dr. Vic Wulsin: Ethically Challenged? Part I”
Read ”Wulsin Pressured into Press Statement by The Cincinnati Beacon? (Ethically Challenged, Part Three)”
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