Sunday, October 08, 2006

Anti-Quack Group Demands Wulsin Cough Up Sponsor of Heimlich AIDS Experiments

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)

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:  http://www.circare.org/foia2/malarioth_protocolocr.pdf

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.



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:



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

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says:
08 Oct 2006  at  07:50 pm | #

In the issue of fairness, Dean, did you contact Dr. Baratz and his National Council?

says:
09 Oct 2006  at  04:32 am | #

Huh?

J Dehner says:
09 Oct 2006  at  05:26 am | #

If she’s got nothing to hide, why shouldn’t Wulsin provide the name of the American sponsor?

Dr. Hankenstein says:
09 Oct 2006  at  06:40 am | #

Yossarian, for the past year, Dr. Baratz has published articles on the Beacon on a variety of Heimlich-related medical quackeries.

says:
09 Oct 2006  at  07:21 am | #

How did Dr. Batatz find out about Dr. Wulsin in the first place? Why was Dr. Baratz cc you in on correspondence to Dr. Wulsin? Where do you fit in?

So - Did you initially contact Dr. Baratz and his National Council with the Dr. Wulsin story OR was this story an issue that he was researching independently?

Dr. Hankenstein says:
09 Oct 2006  at  08:47 am | #

Yossarian: Did you initially contact Dr. Baratz and his National Council with the Dr. Wulsin story OR was this story an issue that he was researching independently?

###

from Cincinnati Business Courier, January 21, 2005

Few of Henry Heimlich’s research theories have provoked as much criticism as his assertion that malaria could be used to cure AIDS. 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.

That puts Henry Heimlich “on a par with the worst of the World War II experiments on humans carried out by the Japanese and the Germans,” said Dr. Robert Baratz, president of Peabody, Mass.-based National Council Against Health Fraud, an independent consumer protection group. He advocates against many forms of alternative medicine.

Baratz said he believes Heimlich violated federal law by not getting approval to conduct the Chinese research from a United States-based Institutional Review Board (IRB). More importantly, he said, it “violates the basic principles of human research, which are not to do any harm.”

(snip)

Dr. Victoria Wells is an epidemiologist who specializes in women’s health issues, particularly the spread of AIDS in Africa. Last February, she was hired by the Heimlich Institute to do a four-month literature review of malariotherapy, a review that ended with her recommendation that the institute should not continue active research.

“A group in Africa is doing research on this and is at the six- to nine-month state of follow-up,” Wells said. “I recommended the institute wait to see what those results showed before pursuing it further.”

###

Anti-Fraud Group: Is there Blood on the Heimlich Award Committee’s Hands?
originally published on Jan. 28th, 2005.

From: “Robert S. Baratz, MD, PhD” Date: Thu, 27 Jan 2005 14:17:30 -0500
To: Cincinnati Business Courier “Healthcare Hero” Award Judges:
Sharron DiMario, John M. Rice, Ph.D, Julie Isphording, Barry Malinowski MD, O’dell Owens

HEIMLICH’S MANEUVERS: IS THERE BLOOD ON THE AWARD’S COMMITTEE’S HANDS?

Tonight the Cincinnati Business Courier will bestow its “Lifetime Hero Award” on Dr. Henry Heimlich for a lifetime of “achievements” in health care.

Recently we wrote the Business Courier to question the propriety of this award (copy of email below). Our argument was that under even mild scrutiny Heimlich has been engaging in illicit research on humans for years. We believe this includes applications of the “Heimlich Maneuver”, especially promotion of use of this for drowning and asthma. The entire story of some of the illicit experiments has yet to be told.

(snip)

It is simply not acceptable to conduct any form of experiments on humans without oversight of an Institutional Review Board for the Protection of Human Studies, and an ethical protocol. Injecting humans with blood from other people that had not been screened, and which contained a disease-containing organism is not just ethically challenged, but criminally wrong. To do this in another country or in a cross-border scheme to avoid scrutiny is equally criminal. There is no doubt that the “malariatherapy” experiments were done. The attached document details that and more. See also this reference for further details.

http://www.circare.org/malariotherapy.htm

###

Eddie says:
09 Oct 2006  at  10:01 am | #

Yo Yossie,
All you have to have been doing is follow this story to realize that Dr. B. has been there almost since Day 1. So you jump in at the last minute and wonder why? We have been asking about the IRB question for 2 years.

Dr. Hankenstein says:
09 Oct 2006  at  02:05 pm | #

The Dean deserves a lot of credit for bringing this important story to public attention, but he can’t claim credit for bringing it to Dr. Baratz or his organization. NCAHF was watching Heimlich’s dangerous quackery long before Dr. Baratz became president.

From: Heimlich’s Audacious Maneuver by Pamela Warrick, Los Angeles Times, October 30, 1994

“He is risking people’s lives and he is trading on the life-saving aura of his name to get people to help him,” said Dr. John Renner of the National Council Against Health Fraud, which has been tracking the Heimlich project.

“After this, he won’t go down in history for the Heimlich maneuver. He’ll go down in history as a bizarre, mad scientist.”

Green Machine says:
09 Oct 2006  at  02:07 pm | #

Yossarian, what does it matter what role the Dean had in this investigation?

Is it not ok for the Dean to investigate Democrats?

You should demand answers from your candidates or at least refrain from shooting the messenger. It appears that Wulsin has some splainin to do.

says:
09 Oct 2006  at  02:55 pm | #

So Dean, Are you walking towrds your car while NOT answering my oringinal question or what?

Did you initially contact Dr. Baratz and his National Council with the Dr. Wulsin story OR was this story an issue that he was researching independently?

I am just curious.

says:
09 Oct 2006  at  03:37 pm | #

Sorry, Yossarian, I thought comments #6 and #8 made pretty clear that Baratz (and his organization) were on this story BEFORE little ol’ me.

says:
09 Oct 2006  at  03:39 pm | #

(In other words, I did not write them, but the 1994 date is long before my time!)

Green Machine says:
09 Oct 2006  at  04:53 pm | #

"Yossarian, what does it matter what role the Dean had in this investigation?”

“Is it not ok for the Dean to investigate Democrats?”

Yossarian, are you walking towards your car and not answering my questions? I’m just curious.

anon says:
09 Oct 2006  at  06:45 pm | #

Yossarian’s questions reveal a great deal about Yossarian. He/she is unconcerned with examining and understanding facts that indicate his/her favored candidate is a liar who appears to have taken part in abusive, illegal research that resulted in the loss of innocent life. What concerns Yossarian is identifying how the negative information came to light.

Yossarian appears clueless that his/her response is identical to the Bush administration’s conventional response when criminal activity is leaked by government sources; they investigate the leak, not the crime.

Good people should work towards all political parties purging themselves of unscrupulous, lying candidates. Obviously that goal is of no consequence to my-side-no-matter-what cheerleaders like Yossarian. We have enough of those in the game already.

komarek says:
09 Oct 2006  at  09:32 pm | #

Dean,

Let me just say again that whatever studies Dr. Heimlich was or is involved with are his responsibility, not Dr. Wulsin’s.

Dr. Baratz can claim what he wants, but I stand by my previous analysis of Dr. Wulsin’s report. Here is what is true:

Wulsin infected no one. She advocated that no further clinical trials occur before all previous studies were published. Wulsin wrote a single report that said, in essence, to Heimlich: You can only proceed when the prior work is out in in the open, and only after you get approval from multiple IRB’s.

Dr. Baratz is really overreaching when he claims that “naturally acquired” malaria infection is the same as Dr. Heimlich’s 1993 injected malaria protocol. In his own letter he quotes Wulsin as stating there was no protocol for the naturally-acquired malaria trials. Indeed, this was one of the very deficiencies Dr. Wulsin identified.

As to the existence of “pre-infection” and “post-infection data,” the simple explanation is that persons in the study were already being treated for HIV when they picked up malaria. Pre-malaria viral load data was in their existing medical records! Of course everyone realizes that AIDS is truly a crisis in Africa, and that, for many, there is no access to effective treatment. The essence of the East African study was delaying malaria treatment by a couple of weeks to see if it brought the HIV infection under control.

Dr. Wulsin shared Dr. Baratz’s concern about inadequate documentation of how patients picked up their malaria infections. She said that it raised questions about the reliability of the data.

Remember, Dr. Wulsin neither devised nor conducted any of this research. She wrote about it after the fact, noting problems with the ethics of the process, and the reliability of outcomes data. And got fired for it.

Finally, the very premise of this post—that Dr. Baratz now seeks to “learn the identity” of the East African study sponsors—is a red herring. I recall numerous Beacon postings identifying various persons as sponsors of this research. You can’t seriously claim both to know and to not know who they were.

--pk---

anon says:
10 Oct 2006  at  06:50 am | #

komarek: Finally, the very premise of this post—that Dr. Baratz now seeks to “learn the identity” of the East African study sponsors—is a red herring. I recall numerous Beacon postings identifying various persons as sponsors of this research. You can’t seriously claim both to know and to not know who they were.

Wulsin’s report does not identify the American sponsor. Your comment pretends that previous discussions on this board have identifed the sponsor. If that’s the case, then you name the sponsor.

Your other arguments are nothing but debating gymnastics designed to exonerate Dr. Wulsin from responsibility. You have no more access to the materials than the rest of us. Nevertheless, you draw sweeping conclusions about the medical care received by the patients.

Rather than posting your comments on the board, I suggest you write directly to Dr. Baratz and let us all know how he responds. His e-mail address is posted under his signature. My guess is that you will find an excuse to avoid doing so.

Mal DeMerde says:
10 Oct 2006  at  06:56 am | #

Here’s komarek again, trying to give cover for Wulsin. Who cares what he says? I’m waiting for Wulsin’s reply. The last time she played dodge ball was with the Dean which resulted in her releasing her report.

The National Council Against Health Fraud has nailed some formidable medical crooks, including a big fish named Heimlich. If I were Wulsin, I’d answer tout suite.

Anon says:
10 Oct 2006  at  07:13 am | #

pk,

gonna take more splainin than that. looks real bad for vic and phil. imagine a d&r both being ruined by the same unethical behavior. spin, spin, spin.

Fresh flowers says:
10 Oct 2006  at  09:59 am | #

I have heard of some experiments going on in Africa under the pretext of new treatments, but I thought they were some epics.

Eddie says:
10 Oct 2006  at  06:53 pm | #

Hey Ko,
Do you have any idea how and IRB operates? The people who are on the boards and who are employed by the organization are RESPONSIBLE for the actions of their investigators. So, Dr. Vic was an employee and therefore a responsible party!

komarek says:
11 Oct 2006  at  06:36 am | #

Folks:

Everyone posting on this blog has their own agenda, including Dr. Baratz.

I reviewed every external link on this Beacon post. Not a single one (except for Dr. Wulsin’s report) relates to the East African clinical trials. The links all focus on Dr. Heimlich’s activities in the 1990s. And even Dr. Baratz never claims that Dr. Wulsin devised or participated in the East African experiments. She wrote about them, just once.

I could be wrong about the “American sponsor” being a part of the public record. The info is there or it isn’t. Still, the claim about wanting to follow up to get the East African patients proper care seems a bit insincere. How much of the cost of care of East African AIDS patients can Dr. Baratz reach into his pocket and finance? We’re not talking about nominal medication copays here!

For some background on the AIDS crisis in Africa, let’s look at a 2000 BBC report.

Aids in America hasn’t been conquered, but it has been controlled. Why, then, are we seeing the epidemic spin out of control in the developing world? Why are the drugs capable of inhibiting HIV having no impact in the countries where the virus is now rampant? Put simply, the people that need the latest anti-retroviral drugs in Africa cannot afford them - and the people that make them are driven by a hard-headed pursuit of profit.

The multi-billion-dollar pharmaceutical corporations of America have spent millions of dollars testing and manufacturing HIV-inhibiting drugs. They are bitter rivals in the market place, but on one key issue they’ve long had a common interest - using international copyright law to maintain their grip on the manufacture, distribution and pricing of Aids drugs, such as AZT, worldwide.

Source: http://news.bbc.co.uk/hi/english/static/in_depth/africa/2000/aids_in_africa/drugs.stm. 


By the way, Dr. Baratz seems to be, for better or worse, a cheerleader for the pharmaceutical industry. The website for the National Council against Health Fraud, http://www.ncahf.org, criticizes alternative medicine - acupuncture, homeopathy, chiropractic - but not once does it mention a pharmaceutical company disaster, of which there have been many.

--pk---

komarek says:
11 Oct 2006  at  08:01 am | #

When I reread Dr. Baratz’ letter I realized I was incorrect when I said he did not accuse Dr. Wulsin of “participating” in the East African experiments. He did, but his accusation is clearly not justified.

Here is what Dr. Baratz said:

These were raw, unredacted, human patient data.  Your analysis was not a literature review, it was a participation in the studies.

But does reading data make Dr. Wulsin a participant? Certainly not. And did Dr. Wulsin ever claim, as Dr. Baratz implies, that she did not have access to raw data? No again.

Here is Dr. Wulsin (on pages 2-3 of her 2004 report (page 5 of the PDF file) describing her work on this project. First she describes the literature review. Then she says:

Secondly, I would conduct independent analyses on available data that had not been published. I have been unable to glean additional data from China, but have obtained raw data from East Africa. Thirdly, I planned to speak to as many of the leaders in the field of Immunotherapy as possible, beginning with HJH and ES, and leading to a site visit of ongoing trials in China and/or East Africa. I have succeeded in speaking directly with several scientists involved with malaria, HIV/AIDS, and/or Immunotherapy, but was unable to speak to key contacts in China and East Africa.
The site visits did not materialize due to severed relations (China) and logistical difficulties (East Africa).

Again, the “news” about Dr. Wulsin’s “participation” is that there is no news. She merely reported on data she read. She could not have “participated” in these experiments because she never even spoke to the people who were conducting the studies!

--pk---

says:
15 Oct 2006  at  05:37 pm | #

As komarek says:


Again, the “news” about Dr. Wulsin’s “participation” is that there is no news.

Many of you ostensibly wanted the report. It’s available here.

I don’t know much about Dr. Baratz except he or associates have gone after practices such as acupuncture, approved for use by the American Medical Association, and eye movement desensitization and reprocessing (EMDR), approved for use by the American Psychological Association (APA).  I can’t speak with any authority on medical issues, but I can let you know the criteria for saying a psychological treatment is “empirically supported” (Chambless & Hollon, 1998; DeRubeis & Crits-Christoph, 1998) is quite stringent.  EMDR has met such criteria.  Thus, to go after EMDR can only be considered agenda driven.

This entire exercise seems to me to be only an attempt at Swift-boating Dr. Wulsin.

References

Chambless, D. L. & Hollon, S. D. (1998). Defining empirically supported therapies.
Journal of Consulting and Clinical Psychology, 66(1), 7-18.

DeRubeis, R. J. & Crits-Christoph, P. (1998). Empirically supported individual and group
psychological treatments for adult mental disorders. Journal of Consulting and Clinical
Psychology, 66(1), 37-52.

anonymous says:
16 Oct 2006  at  08:27 am | #

I’ve often thought that there’s no one who can analyze an epidemiological report quite like a political blogger. Especially if he’s spoon-fed his talking points by a dentist with an agenda.

weight loss says:
16 Apr 2007  at  08:49 am | #

"Patients with prior exposure to malaria or who show a positive reaction to the intradermal test dose of malaria. Such a reaction consists of an area of redness or swelling > 10 mm in diameter, fever, dyspnea, change in blood pressure, or the development of rash within 48 hours. Such patients will be included if it can be demonstrated that they are still susceptible to different acceptable strains.” how come?

AdaWakeman says:
04 Dec 2007  at  03:43 am | #

well...have to tell you something. Did you knew that with 81 days remaining before the Democratic primary in the 2nd Congressional District, the Wulsin campaign is going full speed ahead.
Ada Working Capital

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