Sunday, October 08, 2006
Posted by The Dean of Cincinnati
Sunday night, the following letter was issued to Victoria Wulsin (congressional candidate in Ohio’s 2nd district) from Dr. Robert Baratz, President of the National Council Against Health Fraud. For anyone following the credibility of the Democratic Party in this particular race, the Vic Wulsin stories about malariotherapy are a must-read. In this letter, Baratz demands the name of the American sponsor for malariotherapy experiments. After quoting extensively from Wulsin’s report on malariotherapy to the Heimlich Institute, Baratz documents inconsistencies in Wulsin’s logic—indicating either a fabrication, an ethical disability, or some other lapse of reason unsuitable for an elected representative.
Dear Doctor Wulsin:
In your recently released report, “Immunotherapy and Beyond” ( from December 2004) prepared for the Heimlich Institute, you made reference to “an American sponsor” of Malariotherapy experiments in East Africa.
I am asking you now and immediately to reveal the name of this sponsor of illicit and immoral research. You have previously indicated you know the details. It is time to tell.
The following references in your paper, and the later added “Executive Summary”, are relevant: (bold type has been added for emphasis)
“2000 An American sponsor initiates discussions with the Heimlich Institute regarding Immunotherapy for East Africans.”
“Phase II clinical trials have resulted in positive, though discrepant, results in 20 Chinese and 8 East African HIV-positive individuals. Currently [2004] 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.”
2003 “An American sponsor commences infection with malaria among 12-13 HIV-positive East African patients.”
”2006 East African Phase II Clinical trial is published and/or presented and received with enlightened enthusiasm. East African investigator/s and the Heimlich Institute attain IRB approvals.”
“Reviewing the results of this consultation is limited by several key questions that remain unanswered. 1. What is the infectious agent of malaria in the East African pilot series?”
“[T]he independent analysis of the East African Phase II clinical trial provide interesting information regarding the relationship between malaria and AIDS ...”
“The original Chinese studies reported a consistent rise in CD4 counts, sustained over a 24-month period. More recent follow-up indicate some CD4 counts rise and others decline. The East African data are similarly erratic. Overall, five counts decline (Patients 1, 2, 3, 6, and 7) and three (Patients 4, 5, and 8) rise [see Table 2]. Furthermore, during the nine-month follow-up period the levels fluctuate: inconsistently but not unexpectedly.”
“These infections were acquired naturally, but not treated for at least two weeks following the first fever. These eight patients were among many patients interested in trying this novel therapy.
Patients with CD4 counts in the range of 200 - 500 were considered ideal. Patients with CD4 counts less than 200 were excluded, with the exception of the first volunteer who was particularly keen to participate. Viral loads, history of malaria, age, and pregnancy status were not considered as inclusion or exclusion criteria. The potential risks and benefits were explained to the patients. In addition to these 8 patients, 4-5 others underwent malarial infection, but were lost to follow-up.”
“The possible combinations of levels, durations, and ratios of cytokines associated with the human immune response are infinite. The single best laboratory indicator of HIV progression is probably the viral load itself. This is why the data from East Africa are so valuable.”
“Reasons for the discrepancies include: different infectious agent (Plasmodium vivax in China, probably Plasmodium falciparum in East Africa); different lengths of time of malarial infection; different treatment of malaria; additional medications; different nutritional or immunological status of study subjects; different sub-type ("clade") of HIV; different underlying immune status vis-à-vis malaria; different mode of transmission of HIV (primarily through injecting drug use in China, heterosexual transmission in East Africa); and different mode of transmission of malaria (injected in China, naturally acquired from mosquitoes in East Africa).”
“(Our East African colleagues are currently verifying the malarial infection in the eight subjects.) ”
Although you claim that these were “naturally acquired” infections in Africa your own paper shows this was not true. Please look at the text above.
You said that the patients were “interested in trying this novel therapy.” If it was “naturally acquired” all they had to do was go out in the bush and get malaria. They didn’t have to do anything to “participate” in the study as claimed. They weren’t getting anti-retroviral treatment, or anything else, so why would they “volunteer”? Were they paid? How did they get this so-called “natural infection”?
Dr. Heimlich’s idea of “naturally acquired” is not being bitten by a mosquito.
Please see:
I call your attention to section 4. “Each HIV positive patient will receive a natural inoculation containing malaria parasites.” There is nothing “natural “ about such an inoculation. It is a syringe of blood from someone with malaria.
Additionally I wish to point out to you the headings for the information summarized in Table 2.
Table 2: CD4-Counts and Viral Loads among HIV-positive Patients Infected with Malaria
| # |
Sex |
Age |
Pre-malaria |
Post-malaria |
6weeks |
3months |
6months |
9months |
How could have the sponsor “commenced infection” in 2003 if this was “naturally acquired” as you claim? How could you have known these counts “pre-malaria” with any precision if these were “naturally infected” individuals? Moreover, how could anyone have treated these individuals not knowing the type of malaria they had? Malaria doesn’t spontaneously remit. For there to have been pre- and post-malaria values that were valid there would have to be a time line that was based on the exact date of infection. Further, the treatment for that malaria would have to be based on some knowledge of the type of malaria involved.
Further, how on this God’s earth could these individuals have given consent to be “naturally infected” with malaria?
Any reasonable interpretation of the data suggests that the Chinese experiments were conducted on prisoners, and the East African experiments conducted on sex workers.
Later in your report you went on to say:
Ethics
Studies of Immunotherapy[Malariotherapy] are ethically justifiable as long as three conditions are met.
1. Patients must be informed of - and understand - the relative costs and benefits to Immunotherapy and its alternatives.
2. Research protocols must be approved by local (operating) and donor (managing) institutional review boards.
By investigation at UCLA and through FDA it was clear that the “Chinese” experiments you reviewed did not fit these ethical criteria. No valid US IRB approved the studies, and the IRB at UCLA was not consulted. The Deaconess Hospital, home and owner of the Heimlich Institute since 1998, did not have its IRB approve this work. Thus both the Chinese and the East African studies you reviewed were illicit and immoral.
See: http://www.circare.org/foia2/hhdocs.htm
Further, in your “time line” you indicated that the unnamed “American sponsor” would not get IRB approval until 2006, two years after you wrote your report. Thus the East African experiments you reviewed were immoral and illicit.
Along those same lines the sponsor failed to give conventional, available treatment for HIV infection, “Seven of the eight patients have marked reductions in viral loads without any antiretroviral therapy.” I note that none of the eight were treated, the other individual had higher loads.
By this letter I am asking you to reveal the American sponsor of the East African research. It is clearly violative of the very principles you point out and claim to represent.
In your own words, “‘First, do no harm,’ is a fundamental sine qua non of medical training.”
If you fail to reveal this sponsor you are not only violating your own stated creed as a physician but are sending a clear message to the voters of Ohio as to how you will deal with ethics if elected. You are doing continued harm by allowing these experiments to continue to be conducted on human beings.
As this is written the Speaker of the House, Mr. Hastert, is teetering on the brink of losing his position for failing to reveal that he knew of ethical violations by a recently resigned member. Is your failure to disclose the name of this sponsor any different?
You claimed in your later added Executive Summary that you were only doing a literature review. How is it then that you actually analyzed data in your report? These were raw, unredacted, human patient data. Your analysis was not a literature review, it was a participation in the studies.
I’d add one more thing.
You said, “Clinically, the eight patients continue to do well. Patient #1 has had a secondary infection, treated with antiretroviral drug therapy [HAART]. Patient #8 has been treated with “Bactrim” for tuberculosis but is now well. “
First, how do you know? Second, please note that antiretroviral drug therapy doesn’t treat secondary infections in HIV infected individuals. It only lowers the viral load. (But you said they all didn’t get anti-retroviral treatment—now you contradict yourself). Also, Bactrim (trimethoprim-sulfasoxazole) is not an effective treatment for TB, and most HIV associated TB is multi-drug resistant. As a doctor you should know that.
When you reveal the name of this sponsor we can track this down and get these patients proper care, that is, if they are still alive.
Cordially,
Robert S. Baratz, MD, PhD, DDS
President, National Council Against Health Fraud
Peabody, MA
cc: Cincinnati media
• Share This Article!
 Listen to this article
Help The Cincinnati Beacon Grow! Participate in Social Networking!
Members
Register
Tell us what you think!
Anonymous comments are allowed, but you can log in above to stamp your name and to avoid typing the anti-spam code.
|