I was contemplating writing a post along the same lines as Harriet’s post about evolutionary medicine last week, but then on Sunday morning I saw an article that piqued my interest. Sorry, Harriet, my response, if I get to it, might have to wait until next week, although we could always discuss the usefulness (versus the lack thereof) of evolutionary medicine over a beer or two at The Amazing Meeting in a few days. In the meantime, this week’s topic will revisit a topic near and dear to my heart, a topic that I tend to view (sort of) in a similar way as Harriet views evolutionary medicine, namely personalized medicine or the “individualization” of treatments. It’s a topic I’ve written about at least twice before and that Brennen McKenzie wrote about just last week. In essence, we both pointed out that when it comes to “complementary and alternative medicine” (CAM) or “integrative medicine” treatments for various conditions and diseases, what CAM practitioners claim to be able to do with respect to “individualized care” is nonsense based on fantasy. Science-based medicine already provides individualized care, but it’s individualized care based on science and clinical trials, not tooth fairy science.
Serendipitously, this point was driven home over the weekend in an article by Gina Kolata in the New York Times entitled In Treatment for Leukemia, Glimpses of the Future. While the story is basically one long anecdote that shows what can be done when new genomic technologies are applied to cancer, it also shows why we are a very long way from the true “individualization” of cancer care. It also turns out that I’ve discussed the same basic story before, but here I’ll try to discuss it in a bit more detail.
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.
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:
Every so often, I come across studies that leave me scratching my head. Sometimes, these studies are legitimate scientific studies that have huge flaws or come from an assumption that is very off-base. Other times, they involve what Harriet Hall has termed “tooth fairy science,” wherein the tools of science are used to study a phenomenon that is fantastical, whose very existence hasn’t been demonstrated. Many such studies, not surprisingly, are studies of “complementary and alternative medicine” (CAM) or “integrative medicine” (IM). Modalities like reiki (which is faith healing that substitutes Eastern mysticism for Christian beliefs) and homeopathy (which is, when you boil it down to its essence, sympathetic magic) fall into the category of therapeutic modalities that are based on fantasy but are studied as with the latest tools of science, producing no end to confusing noise. This “tooth fairy science” has, over the last few years, reached its epitome in the application of the latest genomics technology to, in essence, magic, and I’ve recently come across an incredible example of just such a thing. But, first, let’s take a step back to what is going on in medical science now before I introduce a concept that I’ve dubbed “woo-omics.”
A prelude to woo-omics: Genomics, proteomics, everywhere an “omics”
One of the most difficult problems in science-based medicine is how to do a better job identifying which patients will respond to which treatments. Clinical trials, by their very design, have to look at average responses in populations. In essence, a treatment is compared to either placebo or standard-of-care, a choice mainly driven by ethics and whether effective treatments exist for the condition being studied. It is then determined using statistics whether a significant difference exists between the two groups. The difficulty, as any clinician knows, is applying the results of clinical trials to individual patients. In any population, there is, after all, a range of responses to any drug or treatment, and it would be desirable to be able to predict which patients will fall at the end of the bell-shaped curve where the treatment is most effective and which will fall at the end of the curve where the treatment works poorly or not at all.