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Dr. Stanislaw Burzynski’s “personalized gene-targeted cancer therapy”: Can he do what he claims for cancer?

Last week, I wrote a magnum opus of a movie review of a movie about a physician and “researcher” named Stanislaw Burzynski, MD, PhD, founder of the Burzynski Clinic and Burzynski Research Institute in Houston. I refer you to my original post for details, but in brief Dr. Burzynski claimed in the 1970s to have made a major breakthrough in cancer therapy through his discovery of anticancer substances in the urine that he dubbed “antineoplastons,” which turned out to be mainly modified amino acids and peptides. Since the late 1970s, when he founded his clinic, Dr. Burzynski has been using antineoplastons to treat cancer. Over the last 25 years or so, he has opened a large number of phase I and phase II clinical trials with little or nothing to show for it in terms of convincing evidence of efficacy. Worse, as has been noted in a number of places, high doses of antineoplastons as sodium salts are required, doses so high that severe hypernatremia is a concern.

Although antineoplastons are the dubious cancer therapy upon which Dr. Burzynski built his fame, they aren’t the only thing he does. Despite the promotion of the Burzynski Clinic as using “nontoxic” therapies that “aren’t chemotherapy” by “natural medicine” cranks such as Joe Mercola and Mike Adams, Dr. Burzynski’s dirty little secrets, at least as far as the “alternative medicine” crowd goes, are that (1) despite all of the attempts of Dr. Burzynski and supporters to portray them otherwise antineoplastons are chemotherapy and (2) Dr. Burzynski uses a lot of conventional chemotherapy. In fact, from my perspective, it appears to me as though over the last few years Dr. Burzynski has pivoted. No longer are antineoplastons the center of attention at his clinic. Rather, these days, he appears to be selling something that he calls “personalized gene-targeted cancer therapy.” In fact, it’s right there in the first bullet point on his clinic’s webpage, underlined, even! Antineoplastons aren’t even listed until the third bullet point.

But what is “personalized gene-targeted cancer therapy,” according to Dr. Burzynski? Here is how it is described:
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Posted in: Basic Science, Cancer, Clinical Trials, Pharmaceuticals

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A Seal of Approval

I have never belonged to the American Medical Association.  As a student I didn’t want to pay the dues. As a practicing physician I am of the opinion that the AMA has two often mutually exclusive goals (promoting physician income and patient care)  and they are doing both badly.

In the 1990’s the AMA entered into a contract with Sunbeam to get an AMA seal of approval for Sunbeam products, but due to objections the AMA backed out of the deal, in the end costing them almost 10 million dollars.

As was noted at the time:

“I think if we’d gone to trial,” Dr. Relman said on Saturday, ”probably a lot more relevant information would have been uncovered and made available to the membership. As a result of this settlement, we will never know the truth of what happened. It does not let the sun shine in.”

Yeah AMA. It is probably for good reason that only  around 29% f of US physicians belong to the AMA; I have never seen them as representing me or my patients.  Whether the AMA or physicians, I am automatically suspicious of any person or institution who puts their seal of approval on a product.  I figure they are only doing it for the money.  Not that there is anything wrong for that; I am for sale if anyone can meet my price.  Trusting endorsements is like George Carlin’s (I think) observation that he did not like doing standup for stoners since you never know if was the act or the dope that lead to the laughter. I know celebrities are paid for their endorsements; it is not conflict of interest when it is your job to sell a product. At least actors say they only play a doctor on TV.  But when professionals use their authority to recommend products, I would love to see a conflict of interest statement in the recommendation.

When I give a lecture I have to mention my conflicts of interest (COI)* and I have to specifically confirm or deny that I will mention products in which I have a financial interest^. The COI rules are nice, so you know, sort of, who has an interest in pleasing their corporate masters, although I suspect most doctors do not take COI statements seriously.  At IDSA this year most of the speakers gave their COI statements with a short, dismissive sneer and a roll of the eyes.  Me?  Potentially Biased? Puh-please. (more…)

Posted in: Science and Medicine, Science and the Media

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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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Blind-Spot Mapping, Cortical Function, and Chiropractic Manipulation

Picture of the human retina; the bright spot on the right is the blind spot where the optic nerve leaves the eye.

Picture of the human retina; the bright spot on the right is the blind spot where the optic nerve leaves the eye.

Steven Novella recently wrote about so-called “chiropractic neurology” and its most outspoken proponent, Ted Carrick.  In 2005 I published an article in The Scientific Review of Alternative Medicine (Vol 9, No 1, p. 11-15) entitled “Blind-Spot Mapping, Cortical Function, and Chiropractic Manipulation.” It was an analysis of a study Carrick had published.

Carrick read a shorter, popularized version of my critique in Skeptical Inquirer and responded with a diatribe that was inaccurate, distorted what I had said, and accused me of fraud, deception, and mis-representation.  He failed to offer a credible rebuttal of my specific criticisms; and, in my opinion, showed that he failed to understand some of my points. He referred to me as “Ms. Hall” and suggested that I was psychotic. He characterized my e-mail correspondence with him as “bizarre, rude, and offensive.” It was none of those, and I have copies of the e-mails to prove it. Carrick says he “forwarded it to the legal council for the American Chiropractic Association for review.”  Now that strikes me as bizarre.

I am re-publishing the entire text of my article here as an instructive example of what passes for science in the chiropractic neurology community. Readers can judge for themselves whether my critique amounts to fraud and whether I am showing signs of psychosis, whether Carrick is a good scientist and whether his reply to my critique was appropriate. (more…)

Posted in: Chiropractic, Diagnostic tests & procedures, Neuroscience/Mental Health, Ophthalmology

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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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Acupuncture for Amblyopia

An recent article in the journal Ophthalmology reported the results of a clinical trial that evaluated acupuncture as an adjunctive treatment for anisometropic amblyopia. In the abstract, the authors conclude:

Acupuncture is a potentially useful complementary treatment modality that may provide sustainable adjunctive effect to refractive correction for anisometropic amblyopia in young children. Further large-scale studies seem warranted.

A little background information is in order.

In a healthy visual system the various structures in the eye focus light ambient light to form a sharp image on the retina. The retina functions like the CCD in a digital camera. Light energy is transduced to electrical signals, which are transmitted through the optic nerve. The signals from the optic nerve are relayed to the occipital cortex (at the very back of the brain) where they are interpreted into the experience of vision.

Amblyopia is often called “lazy eye”. If during childhood the brain is deprived of quality visual information it does not mature properly and loses the potential for good vision. Any opacity within the eye which significantly degrades the quality of the image forming on the retina (such as congenital cataract) can cause amblyopia. Strabismus (misalignment of the 2 eyes) can also cause amblyopia. If the eyes are not aligned, the brain has difficulty reconciling the disparate images from the 2 eyes. In order to avoid double vision the brain may “ignore” the input from one eye, and corresponding part of the visual cortex will not develop properly. Extreme, uncorrected, refractive errors (nearsightedness, farsightedness or astigmatism) can cause amblyopia. Patients with different refractive errors in their 2 eyes, a condition known as anisometropia, can also develop amblyopia in one eye.
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Posted in: Acupuncture, Ophthalmology, Science and Medicine

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Antioxidants and Exercise: More Harm Than Good?

Multivitamin supplementation has been getting a rough ride in the literature, as evidence emerges that routine supplementation for most is, at best, unnecessary. Some individual vitamins are earning their own unattractive risk/benefit profiles: Products like folic acid, calcium, and beta-carotene all seem inadvisable for routine supplementation in the absence of deficiency or medical indication. Vitamin E, already on the watch list,  looks increasingly problematic, with data recently published confirming the suspected association of supplementation with an elevated risk of prostate cancer.

Reading through the vitamin posts here at SBM, one issue comes through repeatedly: The danger of assuming therapeutic benefits in the absence of confirmatory evidence. Vitamin supplement have the patina of safety and of health, a feature that’s reinforced when you purchase them: You don’t need a prescription, you don’t get counseled on their use, and there isn’t a long list of frightening potential side effects to accompany the product. You can pull a bottle off the shelf, and take any dose you want. After all, how harmful can vitamins be when you can buy 5 pounds of vitamin C at a time, or vitamin E capsules in a 1000-pack?  But the research signals seem to be getting stronger, and most are pointing in the same direction: what we though we knew about antioxidants was based on simplistic hypotheses about nutrition and health. And while we thought we were doing ourselves good with antioxidant supplements, we may have been doing harm. (more…)

Posted in: Herbs & Supplements, Science and Medicine

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The Prince of CAM

Prince Charles is a big supporter of “natural” medicine, which in practice means unscientific and ineffective medicine. He has no particular expertise in this area, and there is absolutely no legitimate reason why he should have any influence over the practice of medicine in the UK. But he is the Prince of Wales, and he has chosen to use that celebrity to promote CAM.

Prince Charles has also recently been criticized for his credulous support for medical nonsense. The Telegraph recently reported that Simon Singh, co-author with Edzard Ernst of Trick or Treatment, and exposer of CAM pseudoscience, spoke about Prince Charles at the recent Hay Festival in India. Singh had some sharp criticism, including:

He only wants scientific evidence if it backs up his view of the natural treatment of health conditions…

We presented evidence that disputes the value of alternative medicine and despite this he hasn’t changed his mind…

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Posted in: Science and Medicine

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HPV Vaccine for Boys

A recent announcement is likely to generate a lot of controversy. The Advisory Committee on Immunization Practices of the CDC has recommended that boys and young men be vaccinated against human papillomavirus (HPV). Previously the guidelines said boys “could” be given the HPV vaccine. Now they have recommended that boys age 11 to 12 “should” be vaccinated, as well as boys age 13 to 21 who have not already had the full series of 3 shots. The vaccine can also be given to boys as young as 9 and to young men age 22 to 26.

The vaccine was originally promoted as a way to prevent cervical cancer. Boys don’t have a cervix, so why should they be subjected to a “girl’s” vaccine? There are some good science-based reasons:

  • Boys can transmit the virus to female sex partners later in life, leading to cervical cancer in women.
  • More importantly, boys themselves can also be directly harmed by the virus. It can cause genital warts, cancer of the head and neck (tongue, tonsils and throat), anal and penile cancer, respiratory papillomatosis, and giant condyloma of Buschke and Lowenstein. In rare cases, immunocompromised patients can develop epidermodysplasia verruciformis.
  • There are other unconfirmed concerns: HPV has been associated with cardiovascular disease in one study.

Some of these conditions are not common, and the most common one, genital warts, may sound trivial. But “a picture is worth a thousand words,” so here is a link to a picture of a giant condyloma of Buschke and Lowenstein as an example of what HPV can do to the unvaccinated. The picture is not pleasant. If you are squeamish, you may not want to look at it. If you can’t even stand to look at it, imagine how devastating it would be to have it appear on your own body, and how nice it would be to be vaccinated against it.

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Posted in: Cancer, Vaccines

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