Articles

The Ethics of “CAM” Trials: Gonzo (Part III)

A Reminder (Mainly to Myself): this Blog will Eventually get back to Discussing the NIH Trial of the “Gonzalez Regimen” for Treating Cancer of the Pancreas†

Which, if you’ll recall, is an arduous dietary and “detox” regimen that includes 150 pills per day, many of which contain pancreatic enzymes, two “coffee enemas” per day, ”a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest,” and more. In Part II I ventured off on a tangent about Laetrile and government sponsorship of trials of implausible cancer “cures.” That became more involved than I had planned (but also more enlightening, or so I hope), and Part III continues on that tangent.

The Politics of “Alternative Cancer Treatments”: the Lamentable Legacy of Laetrile (cont.)

The whole tide is beginning to turn toward metabolic therapy for degenerative disease and preventive medicine. Laetrile…has been the battering ram that is dragging right along with it…B-15,…acupuncture, kinesiology, …homeopathy and chiropractic…And we’ve done it all by making Laetrile a political issue.”

-Michael Culbert, editor of The Choice, the newsletter of the Committee for Freedom of Choice in Medicine. Quoted in 1979.¹

The Next Step: IAT Spawns the OTA Report on “Unconventional Cancer Treatments”…

In 1985, not long after the demise of Laetrile, pushers of implausible cancer treatments were in the news again. This time the treatment was the “immuno-augmentative therapy” (IAT) of Lawrence Burton. According to the 1990 Congressional Office of Technology Assessment (OTA) Report on Unconventional Cancer Treatments,

Treatment consists of daily self-injections of processed blood products, continuing for the life of the patient.

At least four IAT products may be prescribed to treat human cancer patients. The IAT brochure states that some of these are manufactured from the pooled blood of cancer patients and others from the pooled blood of human donors who do not have cancer.

The brochure describes IAT products as:

Deblocking Protein (DP) —an alpha 2 macroglobulin [etc.]

Tumor Antibody 1 (TA1) —a combination of alpha 2 macroglobulin, IgG, IgM, and IgA [etc.]

Tumor Antibody 2 (TA2) —differs from TA1 in potency and possibly composition of immunoglobulins [etc.]

Tumor Complement (TC)…Described as complement C3 that is uniquely active in activating TA1 and TA2. [etc.]

There is no record of Burton’s carrying out biochemical analyses of these materials to identify their components, and his patents describing their manufacture prescribe no tests for identity. Nor has independent analysis of IAT materials been reported from samples provided directly by Burton.

NCI analyzed IAT treatment materials provided by the family of a deceased IAT patient in 1984. According to the NCI analysis, all the treatment materials were dilute blood proteins, in which the major component was albumin, and all were reported to be devoid of the components described in the IRC brochure.

In 1985, according to the OTA report, Burton’s clinic in the Bahamas had been

closed by the Bahamian Government at the recommendation of the Pan American Health Organization (PAHO), after contamination of IAT treatment materials with hepatitis B and the AIDS virus was reported.

Shortly thereafter a group called the “IAT Patients Association”  (IATPA) was founded by Frank Wiewel, “whose father-in-law was a patient of Burton,” and whose name would become better known within a few years. According to the OTA Report,

IATPA was founded in July 1985 with the single goal of re-opening the Immunology Researching Centre (IRC), a clinic in the Bahamas at which Lawrence Burton offers IAT…The leadership of IATPA also persuaded then-Congressman Guy Molinari to hold public hearings on IAT…

Since the reopening of the IAT clinic in March 1986, IATPA leaders and a member of Congressman Molinari’s staff, acting as principal members of the Coalition (and later the Alliance for Alternative Medicine), helped to rally congressional interest, culminating in the request for OTA’s case study of IAT.

Thus it was the closing of the Burton’s IAT clinic that led shortly to the congressional request that the OTA prepare a report on “Unconventional Cancer Treatments.” Molinari’s original request, signed by 40 other legislators, was only for the OTA to design a study of IAT. Representative John Dingell asked that it include “unconventional” cancer treatments in general. (see also here and here for explanations of the OTA Report). The OTA bent over backwards to please advocates, placing on its Advisory Panel 8 members (out of 18) who were “generally supportive of unconventional treatments.”

…Which Tweaks the National Cancer Institute (NCI)

The OTA Report made several recommendations about “Evaluating Unconventional Cancer Treatments.” Among these were criteria for “Best Case Reviews,” which were adopted by the NCI in 1991 and are still in force. The OTA also designed a trial for IAT, as had been its charge, and went out of its way to try to persuade Lawrence Burton to participate in the planning:

OTA enlisted the assistance of academically-based experts in clinical trials, an oncologist from NCI and one from FDA, and asked Burton for his participation. Burton appointed a resident patient who was active in the IATPA, to represent him on this “IAT Working Group.” Burton himself would not participate except at interim and final decision points. As is turned out, this was a significant handicap.

It went downhill from there. At the first meeting in the Bahamas,

Burton’s participation in the discussion was limited mainly to the first morning. At that time, he characterized the OTA draft as “childish and inane.”

There was never a trial of IAT. There was never a case series suggesting safety or efficacy. There were several looks at records and documents by outsiders, including our own Wally Sampson, suggesting ineffectiveness. There were also several cases of hepatitis associated with the treatment, an incidence of skin abscesses at injection sites of 4.5/100 between 1983 and 1984, and evidence that some of the “blood products” had been contaminated with HIV. (All discussed and referenced here)

John Birch Lives: Paranoid IMC Advocates Play the “Freedom Card”

So much for good-faith attempts by the “establishment” to give advocates of Implausible Medical Claims (IMC) their day in court. Once again, however, the good guys failed to learn that lesson. As had been the case with Laetrile, IAT supporters blamed the government and the OTA for Burton’s failings:

…an IATPA member indicated, “in the course of these events, we [IATPA] became convinced that a conspiracy exists which suppresses evaluation of unconventional treatments and have become more broadly politically active in response to this.”

Michael Culbert, the veteran of the Laetrile wars and the author of the quotation that opened this blog entry, was succinct in his assessment of the entire OTA Report:

The document refers several times to the interesting phrase, “scientific medicine,” and therein lies not only the fallacy of the document, but indeed, of the entire thought system of the American medical establishment. We wonder when medicine stopped being an art and became a science. Orthodoxy cannot escape its blind allopathic paradigm; one based on, essentially, discarded Newtonian mechanistic principles.

It cannot any more grasp the concept of individualized, integrated, total metabolic protocols in the management of cancer than it can abandon its obsession with animal tumor systems, cell lines, tumor types, etc.

As Americans drop like flies to the pandemic of cancer, it should be clear that what we need is a new paradigm; a multi-factorial view of cancer causation; a body-wide concept of its management, and an abandonment of the status quo which has ill-served the nation.

Nothing could be more obscene than the spectacle of dying Americans denied freedom of choice in therapy having to go underground, go abroad, or do without. Nothing is more disturbing than the spectacle of government power being used to arrest, harass, chasten, and destroy physicians and researchers who, by adopting so called alternative approaches, are only trying to help their patients.

The vicious system which, on the one hand says “we cannot cure you,” and on the other hand says, “but don’t try some unproven remedy” and warns you always not to sneak off to Tijuana, must come to an end. It is blatantly immoral. And along with it is the randomized, placebo controlled, double-blind study. I can’t think of anything more immoral than using that as a rational scientific exercise.

The solution to all this, of course, is not scientific. It is political. If people have to take to the streets to secure what should be their birthright, freedom of choice in medicine, against the tyrannical concentration of economic and vested interests, then they will.

“Medical writer” Ralph Moss also addressed the OTA. He stated that he had worked at Memorial Sloan-Kettering as “assistant director of public affairs” from 1974-77. He claimed that he had “[blown] the whistle on [Sloan-Kettering's] cover-up” of an animal study of Laetrile, performed by Dr. Kanematsu Sugiura, which found that “in the control animals 80% had lung metastases but only 20% had them in the treated animals.” Moss chastised the OTA for allegedly not having acknowledged the “cover-up”:

This report on “Unconventional Cancer Treatments” was supposed to investigate a coverup. Instead it has become part of that coverup. In its present form, it will set back the study of non-toxic cancer treatments for years to come.

People are dying of cancer in this country. You remind me of that Ron Cobb cartoon of a little child dying of malnutrition. There are 8 or 10 doctors standing around its crib, pointing and questioning and rubbing their chins, like “What’s going on? We have to get the medical reports on this.”

People are dying.

We cremated Ron Wolin this week. It’s a very interesting story. Ron was co-founder of the Patients’ Rights Legal Action Fund and a patient of Dr. Burzynski. He was lying on a couch in Dr. Burzynski’s office in Houston when the FDA came in and seized 220,000 documents from Burzynski’s office. They took 11 filing cabinets, loaded them onto a U-Haul and drove away. And the very same day, Dr. Burton’s clinic was shut down in the Bahamas, July 17, 1985.

Now, I know what’s going on here and I’m not fooled. And I’ll tell you something: repression breeds resistance. Ron Wolin watched those records go out the door, then he founded an organization which forced the government to a standstill in the courts. And the same day, by coincidence, Frank Wiewel was in Dr. Burton’s clinic. You know, just a guy, with his father-in-law. And he watched Burton’s clinic closed and look, here he is. He’s the head of two cancer organizations. And I was just a guy who happened to be in the right place at the right time.

So, I’m not afraid of you, and I’m not afraid of what you’re doing. You’ll continue with this? Fine. We’ll continue to fight you.

Compare Moss’s account of the Sloan-Kettering “cover-up” with the account given on p. 23  of FDA Commissioner Kennedy’s 1977 report.

Moss reported the opinion of another person whose views would be heard again:

Gar Hildenbrand, who was both an Advisory Panel member and an outspoken activist, called on supporters of the Gerson diet and cancer patients in general to practice civil disobedience outside the meeting.

“On March 9th,” he wrote, “hundreds of people with cancer, people recovering from cancer, and worried well people will walk into the streets. In the early morning, at the Office of Technology Assessment, cancer patients will lie down in front of the doors to tell Congress: ‘You allow this system to go unchallenged OVER MY DEAD BODY.’ “

Hildenbrand was, and is, a conspicuous proponent of Gerson Therapy, another “dietary” and “detoxification” scheme that relies heavily on coffee enemas. His own views (“As a medication, the coffee enema is in a class by itself”) and links to other such opinions can be found here.

The “Harkinites” are Born

Iowa Congressman Berkley Bedell was one of the signatories of Rep. Guy Molinari’s request to the OTA. The above-mentioned Frank Wiewel may have helped Bedell find “alternative” treatments after Bedell had found out that he had prostate cancer. Bedell was not quite as rabid in his views as were Wiewel, Hildebrand, and Moss, but was every bit as ignorant of biology and science. Those four—Bedell, Wiewel, Moss, and Hildebrand—would soon become known as the “Harkinites”: the “experts” hand-picked by Iowa Senator Tom Harkin to advise the Director of the NIH Office of Alternative Medicine, the brainchild of Harkin and Bedell.

Next week: the OAM, Gonzalez reappears, and more.

1. Bruzelius N. The Merchants of Laetrile. New England (magazine section), Boston Sunday Globe, June 17, 1979. Quoted in: Young JH. Laetrile in Historical Perspective. In: Young JH. American Health Quackery. Princeton, Princeton Univ. Press 1992, p. 245.

…………………………

†The “Gonzalez Regimen” Series:

1. The Ethics of “CAM” Trials: Gonzo (Part I)

2. The Ethics of “CAM” Trials: Gonzo (Part II)

3. The Ethics of “CAM” Trials: Gonzo (Part III)

4. The Ethics of “CAM” Trials: Gonzo (Part IV)

5. The Ethics of “CAM” Trials: Gonzo (Part V)

6. The Ethics of “CAM” Trials: Gonzo (Part VI)

7. The “Gonzalez Trial” for Pancreatic Cancer: Outcome Revealed

8. “Gonzalez Regimen” for Cancer of the Pancreas: Even Worse than We Thought (Part I: Results)

9. “Gonzalez Regimen” for Cancer of the Pancreas: Even Worse than We Thought (Part II: Loose Ends)

10. Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 1

11. Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 2

Posted in: Health Fraud, Medical Ethics, Politics and Regulation, Science and Medicine

Leave a Comment (9) ↓

9 thoughts on “The Ethics of “CAM” Trials: Gonzo (Part III)

  1. TsuDhoNimh says:

    During the big Laetrile mess in the 1970s, I was working in a large east coast medical center.

    One of the oncologists brought us a vial of what was supposed to be Laetrile that one of his desperate patients had brought back from Mexico. We analysed it, and found 100% lactose. Milk sugar, sold at hundreds of dollars a vial. Now that’s obscene.

  2. pmoran says:

    Before he dies, Ralph Moss should apologise to cancer patients for his key role in furthering the notion that there is a conspiracy to suppress alternative cancer cures.

    He has evolved into a comparatively sane commentator on “alternatives”, being prepared to sometimes expose fraud and bad science. He must by now know that his evaluation of the SLoan-Kettering Laetrile studies was utterly wrong. I note that he does not now recommend Laetrile to clients.

    Fat chance.

  3. overshoot says:

    Dang — that is some seriously high-octane WWW there:

    The document refers several times to the interesting phrase, “scientific medicine,” and therein lies not only the fallacy of the document, but indeed, of the entire thought system of the American medical establishment. We wonder when medicine stopped being an art and became a science. Orthodoxy cannot escape its blind allopathic paradigm; one based on, essentially, discarded Newtonian mechanistic principles.

    It cannot any more grasp the concept of individualized, integrated, total metabolic protocols in the management of cancer than it can abandon its obsession with animal tumor systems, cell lines, tumor types, etc.

    [...]

    The solution to all this, of course, is not scientific. It is political. If people have to take to the streets to secure what should be their birthright, freedom of choice in medicine, against the tyrannical concentration of economic and vested interests, then they will.

    I am stunned. We could spend a week on this passage alone. I’m not prepared to contemplate what Stu would do with this one. (WWSD? What Would Stu Do?)

  4. qetzal says:

    It cannot any more grasp the concept of individualized, integrated, total metabolic protocols in the management of cancer than it can abandon its obsession with animal tumor systems, cell lines, tumor types, etc., etc., blah, blah, blah

    Translation: We should be allowed to make up a different ‘treatment’ for every patient, and charge the poor saps whatever we want, without any regulations infringing on our inalienable rights to rip off desparate dying people. Besides, your outmoded reductionist, Newtonian style medicine can’t prove our magic herbs aren’t working!

Comments are closed.