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Dr. Stanislaw Burzynski, antineoplastons, and the selling of an orphan drug as a cancer cure

Over the last couple of weeks, I’ve been spending a lot of time (and, characteristically, verbiage) analyzing the phenomenon known as Dr. Stanislaw Burzynski and his “cancer cure” known as antineoplastons. In part I of this series, Stanislaw Burzynski: Bad medicine, a bad movie, and bad P.R., I used the legal threats against bloggers criticizing the credulous promotion by the British press of fundraising campaigns to send children with terminal cancer to the Burzynski Clinic and the promotion of the medical propaganda movie Burzynski The Movie: Cancer Is Serious Business to review the movie’s claims and look into Burzynski’s claims for antineoplastons. Not surprisingly, I found the evidence for extravagant claims for their anticancer effects unconvincing. In part II, Dr. Stanislaw Burzynski’s “personalized gene-targeted cancer therapy”: Can he do what he claims for cancer?, I looked into Dr. Burzynski’s recent efforts to “diversify his portfolio, in which he has apparently decided to ride the new wave of genomic medicine to claim he can do “personalized, gene-targeted cancer therapy.” I concluded that he does appear to do that, only very badly, in essence “making it up as he goes along.”

In this third and final part, I want to come back to antineoplastons, because it has been pointed out to me that there is an aspect of this story that has received little attention. One reader in particular has helped enormously in my education about this aspect of the Burzynski saga. I wish I could credit this person by name, but, for reasons I fully understand, I can’t. However, this person’s input was essential, and I’ve even appropriated (with permission, of course) a little bit of text here and there from our e-mail exchanges to “integrate” into this post. Putting this together with information in my previous posts, I think we can come to some conclusions about what it is that Dr. Burzynski is really doing.

Burzynski and an orphan drug

In the first part of this series, I pointed out that back in the 1970s Dr. Burzynski claimed to have discovered cancer-fighting substances in human urine, which he dubbed “antineoplastons,” claiming that patients with cancer had lower levels of these substances in their blood and urine. However, I was pretty vague about just what these substances were, other than to point out that they were modified amino acids and that since 1980 Dr. Burzynski has been synthesizing them in a chemistry lab rather than isolating them from urine as he had done up until then. This vagueness came simply from my interest in moving straight to looking at Burzynski’s claims rather than what these substances were. In retrospect, that might have been a mistake. The reason is that understanding what two of Burzynski’s antineoplastons are is critical to understanding what he is doing with them and why he might occasionally appear to be observing an antitumor response.
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Posted in: Basic Science, Cancer, Legal, Medical Ethics, Pharmaceuticals, Politics and Regulation

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Integrative Medicine: “Patient-Centered Care” is the new Medical Paternalism

Integrative Pitchmen

Several of us have written about how contemporary quacks have artfully pitched their wares to a higherbrow market than their predecessors were accustomed to, back in the day. Through clever packaging,* quacks today can reasonably hope to become professors at prestigious medical schools, to control and receive substantial grant money from the NIH, to preside over reviews for the Cochrane Collaboration, to be featured as guests and even as hosts on mainstream television networks and on PBS, to issue opinions in the name of the National Academy of Sciences, to be patronized by powerful politicians, and even to be chosen by U.S. presidents to chair influential government commissions.

The most successful pitch so far, and the one that the fattest quack-cats of all have apparently decided to bet the farm on, is “integrative medicine” (IM). Good call: the term avoids any direct mention of the only thing that distinguishes it from plain medicine. Its proponents, unsurprisingly, have increasingly come to understand that when they are asked to explain what IM is, it is prudent to leave some things to the imagination. They’re more likely to get a warm reception if they lead people to believe that IM has to do with reaching goals that almost everyone agrees are worthy: compassionate, affordable health care for all, for example.

In that vein, the two most consistent IM pitches in recent years—seen repeatedly in statements found in links from this post—are that IM is “preventive medicine” and that it involves “patient-centered care.” I demolished the “preventive” claim a couple of years ago, as did Drs. Lipson, Gorski, and probably others. Today I’ll explain why the “patient-centered care” claim is worse than fatuous.

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

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Pediatrics & “CAM” II: just wrong

In November, the journal Pediatrics published an entire supplement devoted to Pediatric Use of Complementary and Alternative Medicine: Legal, Ethical and Clinical Issues in Decision-Making. The authors purport to have “examined current legal, ethical, and clinical issues that arise when considering CAM use for children and identified where gaps remain in law and policy.” (S150) Their aim is to “illustrate the relevance and impact of identified [ethical, legal and clinical] guidelines and principles,” to recommend responses, identify issues needing further consideration, and thus “assist decision makers and act as a catalyst for policy development.” (S153)

Unfortunately, as we saw in Pediatrics & “CAM” I: the wrong solution, the authors’ solution for the “issues that arise when considering CAM use for children” consist, in the main, of placing a huge burden on the practicing physician to be knowledgeable about CAM, keep up with CAM research, educate patients about CAM, warn patients about CAM dangers, refer to CAM practitioners, ensure that CAM practitioners are properly educated, trained and credentialed, and so on.

Limit CAM? Not happening

Curiously absent are recommendations placing responsibility on those who profit from the sale of CAM products and services — the dietary supplement manufacturers, homeopaths, acupuncturists, and the like — whose actions are directly responsible for the deleterious effects on patients’ health detailed in the supplement articles and described in the earlier post.

Apparently the authors’ view is that there is no accommodation to CAM too onerous to ask the practicing physician or the patient to bear. Even though they plainly locate the problems they describe — a missed diagnosis, ineffective treatments, drug therapy interactions, poor advice — in the CAM services and products themselves, suggesting that these services and products be limited or eliminated never seems to cross their minds.

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Posted in: Acupuncture, Chiropractic, Herbs & Supplements, Homeopathy, Legal, Medical Ethics, Politics and Regulation, Vaccines

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Update on CPSOs Draft Policy

Four months ago David Gorski wrote about the  College of Physicians and Surgeons of Ontario’s (CPSO) draft policy on “non-allopathic” medicine. He pointed out:

It’s obvious from the wishy-washy approach to the scientific basis of medicine, the waffle words when it comes to whether an “allopathic” physician should support “non-allopathic” therapies, and the apparently inadvertent use of language favored by quacks that there were far too many “alternative” practitioners involved in drafting this policy.

I agree.  The proposed policy addresses the issue of so-called complementary and alternative medicine (CAM) and has drawn serious criticism from Canadian physicians (at least those who are paying attention and have the slightest clue about what is going on). The backlash is good to see, but it is not nearly vigorous enough.

There is now an update to this story as the CPSO has published a revised policy proposal. There are some improvements, based on the criticism, but still there are problems with the policy.

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Posted in: Politics and Regulation, Public Health

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Stanislaw Burzynski: Bad medicine, a bad movie, and bad P.R.

And the Lord spake, saying, “First shalt thou take out the Holy Pin. Then shalt thou count to three, no more, no less. Three shall be the number thou shalt count, and the number of the counting shall be three. Four shalt thou not count, neither count thou two, excepting that thou then proceed to three. Five is right out. Once the number three, being the third number, be reached, then lobbest thou thy Holy Hand Grenade of Antioch towards thy foe, who, being naughty in my sight, shall snuff it.

Cleric from Monty Python and the Holy Grail

I’ve always wondered about the power of the number three. When it comes to quackery propaganda movies, certainly three seems to be the magic number. For example, The Greater Good, an anti-vaccine propaganda film, features three anecdotes, three children allegedly suffering from vaccine injury, and it interspersed its interviews with experts, both real (such as Dr. Paul Offit) and phony (such as Barbara Loe Fisher) with vignettes from these children’s stories interspersed between them in a highly biased manner. I have to wonder whether these cliches are taught in film school, given that they seem to be so common. Such were the thoughts running through my brain as I watched the latest medical propaganda film by writer/producer Eric Merola that’s floating around the blogosphere and the film circuit, Burzynski The Movie: Cancer Is Serious Business. In this movie, there are three testimonials, and, if anything, they are far more manipulative than even the testimonials featured in The Greater Good, because each of them are of the type that portrays doctors as sending a patient home to die; that is, until a “brave maverick doctor,” one Stanislaw R. Burzynski, MD, PhD, comes to the rescue with his unconventional and unproven therapy. The only difference is that this film counts testimonials up to the number three in the beginning as “proof” that Burzynski can cure cancer before lobbing the Holy Hand Grenade of Burzynski towards its foes in the hopes that, being naughty in the filmmaker’s sight, the FDA and Texas Medical Board will snuff it. Or, as a caption says right at very the beginning of the movie:

This is the story of a medical doctor and PhD biochemist who has discovered the genetic mechanism that can cure most human cancers. The opening 30 minutes of this film is designed to thoroughly establish this fact — so the viewer can fully appreciate the events that follow it.

It turns out that the grenade is a dud.
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Posted in: Basic Science, Cancer, Clinical Trials, Medical Ethics, Politics and Regulation, Science and the Media

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Pediatrics & “CAM” I: the wrong solution

Oh no!  Not again! The venerable medical journal Pediatrics devotes an entire supplement this month to Pediatric Use of Complementary and Alternative Medicine: Legal, Ethical, and Clinical Issues in Decision-Making.

We sense from the very first sentence that we are in familiar territory:

Rapid increases the use of complementary and alternative medicine (CAM) raise important legal, ethical, clinical, and policy issues. (S150)

“Rapid increases”? And evidence of these “rapid increases?” None cited.

We do, however, see the same shopworn reference to popularity deconstructed elsewhere on SBM. What we learned by actually examining “the large 2007 US survey” which purportedly “revealed that ~4 in 10 adults and 1 in 9 children and youth used CAM products or therapies within the previous year”(S150) is that

…most hard-core CAM modalities are used by a very small percentage of the population. Most are less than five percent. Only massage and manipulation are greater than 10 percent. These numbers are also not significantly different from 10 or 20 years ago — belying the claim that CAM use is increasing.

We also find this definition of “CAM”:

a broad domain of healing resources …other than those intrinsic to the politically dominant health system of a particular society or culture in a given historical period. (S150)

I’m not sure what it takes to become “intrinsic” to the “politically dominant” healthcare system. If it includes being legal, licensed or covered by public and/or private insurance, that would appear to disqualify dietary supplements, chiropractic, acupuncture, homeopathy, homeopathic products and naturopathy as “CAM” in some, or in some cases all, of the American states.

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Defining what a “physician” is

The very concepts of “complementary and alternative medicine” (CAM) and “integrative medicine” (IM), the former of which “complements” science-based medicine with quackery and the latter of which “integrates” pseudoscience-based with science-based medicine are all about slapping a veneer of scientific legitimacy onto something that has failed to achieve such legitimacy through actual basic, translational, and clinical science. The reason I start out by saying this is to emphasize that CAM/IM is all about using language to persuade that pseudoscience is actually science-based. It’s far more about marketing than accurately communicating concepts. In CAM, everything is “holistic,” and doctors “care for the whole patient,” while “Western medicine” is “reductionistic” and “allopathic.” At the very heart of this language is a false dichotomy: That you must either embrace pseudoscience or that you somehow can’t provide care as compassionate and caring as what the quacks supposedly provide, nor are you able to provide for the emotional needs of your patients. There are two false dichotomies, actually, in that there is also the not-so-subtle implication in CAM that you can’t be truly “holistic” without—you guessed it—embracing the pseudoscience that is at the heart of many CAM/IM modalities.

This use and abuse of language for propagandistic purposes in CAM/IM is not limited to just these examples. In fact, the misuse of language infuses the whole enterprise of CAM/IM to the point that its adherents, not content with being mere “practitioners,” are trying to claim the very title of “physician” for themselves. I learned this from John Weeks, the main force behind the Integrator Blog, a blog dedicated to issues of CAM and IM. He’s the one who first let me know about Andrew Weil’s attempt to put together a board certification in IM. In particular, his reporting on the reaction of CAM/IM practitioners, both physicians and non-physicians, to this initiative by Andrew Weil was most illuminating to me. What was most telling was how further propagandistic use of the language focused on “dominance” by MDs, which in this case struck me as actually being closer to the truth than the usual CAM-speak is. In any case, Dr. Weil’s initiative does indeed appear to be more about taking control of CAM for physicians, his high-minded language about “establishing standards” notwithstanding.

This time around, Weeks has provided me with an education about how alternative/CAM/integrative practitioners now covet the title of “physician”. In the process, he also uses and abuses language in the same way that Andrew Weil and CAM/IM advocates do. This time around, it’s all about co-opting the title of “physician” for non-physician CAM practitioners. It’s bad enough to me when actual physicians are seduced by the pseudoscience of CAM, but this effort appears to be an intentional strategy designed to confuse the public by proclaiming as physicians practitioners who lack the essential skills to be a physician, such as acupuncturists, chiropractors, homeopaths, and naturopaths.
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Dummy Medicine, Dummy Doctors, and a Dummy Degree, Part 2.3: Harvard Medical School and the Curious Case of Ted Kaptchuk, OMD (concluded)

Dummy Medicine, Dummy Doctors, and a Dummy Degree, Part 2.3: Harvard Medical School and the Curious Case of Ted Kaptchuk, OMD (concluded)

A Loose End

In the last post I wondered if Ted Kaptchuk, when he wrote the article titled “Effect of interpretive bias on clinical research,” had understood this implication of Bayes’s Theorem: that interpretations of most scientific investigations are exercises in inverse probability, and thus cannot logically be done without consideration of knowledge external to the investigation in question. I argued that if Kaptchuk had

…understood the point when he wrote his treatise, he was dishonest in not explaining it and in not citing at least one pertinent article, such as Steven Goodman’s (which I’m willing to bet he had read). If he didn’t understand the point he should have withheld his paper.

In researching more of Kaptchuk’s opinions I’ve discovered that he had certainly read Goodman’s article, but that he either didn’t understand it or preferred to obscure its implications in deference to his ongoing project in belittling scientific knowledge. In a letter to the editor of the Annals of Internal Medicine in 2001, Kaptchuk opined that even if “more trials of distant healing with increased methodologic rigor” were positive, it still would not “be persuasive for the medical community”:

The situation resembles the predicament with homeopathy trials, another seemingly implausible intervention, where the evidence of multiple positive randomized, controlled trials will not convince the medical community of its validity. Additional positive trials of distant healing are only likely to further expose the fact that the underpinning of modern medicine is an unstable balance between British empiricism (in the tradition of Hume) and continental rationalism (in the tradition of Kant).

…It seems that the decision concerning acceptance of evidence (either in medicine or religion) ultimately reflects the beliefs of the person that exist before all arguments and observation. [Kaptchuk cites the second of the two Goodman articles that I referred to above, discussed here]

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CAM practitioners react to Andrew Weil’s proposal for a board certification for integrative medicine. It isn’t (all) pretty.

About a month ago, I discussed a rather disturbing development, namely the initiative by Dr. Andrew Weil to set up something he was going to call the American Board of Integrative Medicine, all for the purpose of creating a system of board certification for physicians practicing “integrative medicine” (IM), or, as I prefer to call them, physicians who like to integrate pseudoscience with their science, quackery with their medicine. Harsh? Yes. Accurate? Also yes. Unfortunately, many medical centers, both academic and community, are hopping on the IM bandwagon while more and more medical schools are “integrating” pseudoscience into their curricula. While one might expect Josephine Briggs of the National Center for Complementary and Alternative Medicine (NCCAM) to be cozy with IM, depressingly, even current director of the National Institutes of Health, Francis Collins, seems to have fallen into the trap.

As was admitted by Dr. Weil and his colleagues, this decision to create a board certification in IM was a huge about-face in that Weil had always argued that IM should be infused into all specialties of medicine. What happened, of course, is that once again marketing won out over idealism. Dr. Weil was concerned that there were lots of physicians and practitioners out there claiming to practice “integrative” medicine, many of whom had no qualifications in the field. At this point, the wag in me can’t resist pointing out that, given that IM “integrates” pseudoscience with science and that there really are no standards, scientific or otherwise, to guide IM practitioners (mainly because so much of IM is rank pseudoscience), why would this matter? The answer, again, comes down to branding and turf protection.

All of this is why seeing the reactions to Dr. Weil’s initiative from members of the “complementary and alternative medicine” (CAM) and IM community is very instructive. Fortunately, John Weeks of the Integrator Blog has come through again, quoting over twenty different people, including physicians, naturopaths, chiropractors, journalists, and other IM practitioners in an article entitled, appropriately enough, Integrator Forum: 20 Voices on Weil/U. Arizona and the American Board of Integrative Medicine. Yours truly is even mentioned (disparagingly, of course).

Uncharacteristically (for me), I’ll cut to the chase and tell you the results before I show you some of the quotes (with, of course, my own translation of what the IM-speak really means). Basically, physicians practicing IM tend to love what Dr. Weil is doing. All other practitioners (chiropractors, naturopaths, etc.) hate it. Of course, that’s not a big surprise given that Weil’s plan would in essence cut out all non-physician IM practitioners from being able to call themselves “integrative physicians” or, at the very least, to relegate them to a lower, non-board-certified rung in the practice hierarchy, which, I suspect, was the point all along. Andrew Weil wants IM to be “respectable,” and to him it will only become so if the riff-raff (i.e., non-physicians) are excluded.
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The Cure

Legislative Alchemy

In Legislative Alchemy I: Naturopathy, II: Chiropractic and III: Acupuncture, we learned how state legislatures transform scientifically implausible and unproven diagnostic methods and treatments into legal health care practices. Examples typical of the sheer nonsense found in both proposed and actual legislation include:

Naturopathic health care [is] a system of health care practices for the prevention, diagnosis, evaluation and treatment of illnesses, injuries and conditions of the human body through the use of education, nutrition, natural medicines and therapies and other modalities which are designed to support, stimulate or supplement the human body’s own natural self-healing processes.

[Chiropractic is] the science of adjustment, manipulation and treatment of the human body in which vertebral subluxations and other malpositioned articulations and structures that may interfere with the normal generation, transmission and expression of nerve impulse between the brain, organs and tissue cells of the body, which may be a cause of the disease, are adjusted, manipulated or treated.

[Acupuncture is] a form of health care that is based on a theory of energetic physiology that describes and explains the interrelationship of bodily organs or functions with an associated acupuncture point or combination of points that are stimulated in order to restore the normal function of the bodily organ or function.

This is gobbledygook, tarted up with a few scientific-sounding terms — “physiology,” “tissue cells,” “diagnosis.”

 

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