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NIH Director Francis Collins doesn’t understand the problem with CAM

As the sole cancer surgeon among our stable of Science-Based Medicine (SBM) bloggers, I’m probably the most irritated at the infiltration of pseudoscience into academia (or, as we sometimes like to call it, quackademic medicine) in the realm of cancer. Part of the reason, of course, is that cancer is so common and that the consequences of adding pseudoscience to cancer therapy are among the most devastating. Witness, for instance, the use of Gonzalez therapy to treat pancreatic cancer, a form of quackery that harms patients and resulted in incredibly unethical and disastrous clinical trial of Gonzalez quackery versus chemotherapy whose results were entirely predictable, given the lack of prior plausibility of the treatment: Gonzalez protocol patients did worse, with no evidence that the therapy impacted the natural history of the disease and the Gonzalez patients scoring lower on quality of life measures. Or look at what happens when patients with breast cancer choose quackery over science-based therapy.

I realize that “complementary and alternative medicine” (CAM) or, what quackademics like to call it now, “integrative medicine” (IM) is meant to refer to “integrating” alternative therapies into SBM or “complementing” SBM with a touch of the ol’ woo, but I could never manage to understand how “integrating” quackery with SBM would do anything but weaken the scientific foundation of medicine. Moreover, weakening those foundations would have more consequences than just “humanizing” medicine; weaker scientific standards would allow not just ancient quackery like traditional Chinese medicine (TCM) into academia, but it would also provide an opening for drug and device companies to promote their wares under less rigorous requirements for evidence. There’s also perhaps a touch of personal embarrassment involved. After all, oncology and cancer surgery tend to be specialties that are the most steeped in science. If I had to rank specialties for how science-based they are, I’d certainly put oncology near the top, which is why I tend to come down so hard on “integrative oncology” and, even worse, “naturopathic oncology.”

Consequently, I was doubly disturbed several months ago when I learned that the director of the National Institutes of Health, Francis Collins, had agreed to be the keynote speaker at the Eight International Society for Integrative Oncology Conference in Cleveland, OH. I say “doubly” disturbed because it disturbed me that Francis Collins would agree to speak at such a function and, perhaps even more, because the host institution was Case Western Reserve University, the institution where I both completed my surgery residency and my PhD in Physiology and Biophysics. Sadly, it now appears that my old stomping grounds at University Hospitals has been thoroughly infiltrated with quackademic medicine, as evidenced by this clinical trial of reiki for psoriasis that’s making the rounds of news services and the offering of acupuncture, reiki, and even reflexology at various UH facilities through the University Hospitals Connor Integrative Medicine Network. Let me tell you, there was none of this pseudoscience going on when I finished my residency there in 1996. Seeing it there now provokes a reaction in me not unlike Sylvester Junior’s reaction when his father Sylvester embarrasses him, particularly when I noted that the director of the CWRU Comprehensive Cancer Center, Dr. Stanton L. Gerson, was to give one of the keynote talks, entitled, “The Future of Integrative Oncology.” (Hint for those of you not familiar with classic Looney Tunes cartoons: A paper bag is involved.) I guess that by expressing my extreme disappointment and embarrassment that the institution where I learned to become a surgeon has during the last 15 years gone woo, I’ve probably just killed any opportunity I might have to work at the Case Comprehensive Cancer Center ever again. Oh, well, add it to the list, along with Beth Israel and my alma mater the University of Michigan.)

Back when I first learned about it, I thought about blogging the meeting, but without much concrete to go on, given the copious other SBM-related topics to blog about, all I could do was to write a critical open letter to Dr. Collins about his decision to accept the offer to be the keynote speaker at the Society for Integrative Oncology (SIO). Then yesterday I saw popping up in my e-mail a notice from the American Society of Clinical Oncology (ASCO), along with a link to a story in its publication The ASCO Post entitled NIH Director Calls for Rigorous Evaluation of Integrative Medicine to Provide Evidence of Efficacy.

Et tu, Dr. Collins?
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Posted in: Basic Science, Cancer, Clinical Trials, Politics and Regulation

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Why Do We Really Need Clinical Trials?

A point I make over and over again when talking about new or alternative therapies that are not supported by good clinical trial evidence is that lower-level evidence, such as theoretical justifications, anecdotes, and pre-clinical research like in vitro studies and animal model testing, can only be suggestive, never reliable proof of safety or efficacy. It is necessary to begin evaluating a new therapy that does not yet have clinical evidence to support it by showing a plausible theory for why it might work and then moving on to demonstrate that it actually could work through pre-clinical research, which includes biochemistry, cell culture, and animal models. These sorts of supporting preclinical evidence are what we refer to when we refer to the “prior plausibility” of a clinical study. But this kind of evidence alone is not sufficient to support using the therapy in real patients except under experimental conditions, or when the urgency to intervene is great enough to balance the significant uncertainty about the effects of the intervention.

In support of this conclusion, we can consider the inherent unreliability of individual human judgments and all the many ways in which inadequately controlled research can mislead us. And we can reflect on how promising results in early trials often melt away when better, larger, more rigorous studies are done that better control for bias (the so-called Decline Effect). And it is not at all difficult to compile a large list of examples of the harm inadequately studied medical interventions can cause.

But what I’d like to do here is focus on a particularly good specific example of why thorough clinical trial evaluation of promising ideas is not just a nice extra to confirm what we already believe is true, it is the only way to genuinely know whether our treatments to more good than harm.

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Posted in: Cancer, Clinical Trials, Herbs & Supplements, Science and Medicine

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The Cancer Cure Anecdote

Dr. Ian Gawler, a veterinarian, suffered from osteogenic sarcoma (a form of bone cancer) of the right leg when he was 24 in 1975. Treatment of the cancer required amputation of the right leg. After completing treatment he was found to have lumps in his groin. His oncologist at the time was confident this was local spread from the original cancer, which is highly aggressive. Gawler later developed lung and other lesions as well, and was given 6 months to live due to his metastatic disease.

Gawler decided to embark on an alternative treatment regimen, involving coffee enemas, a vegetarian diet, and meditation. Eventually he was completely cured of his terminal metastatic cancer. He has since become Australia’s most famous cancer survivor, promoting his alternative approach to cancer treatment, has published five books, and now runs the Gawler Foundation.

At least, that is the story he believes. There is one major problem with this medical tale, however – while the original cancer was confirmed by biopsy, the subsequent lesions were not. His oncologist at the time, Dr. John Doyle, assumed the new lesions were metastatic disease and never performed a biopsy. It was highly probable – the timing and the location of the new lumps following a highly aggressive cancer. But even a diagnosis that is 95% likely will be wrong in 1 patient out of 20 – which means a working physician will have patients with the 5% diagnosis about once a week. The standard of practice today would be to do a biopsy to get tissue confirmation of the diagnosis, and rule out the less likely alternatives.

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Posted in: Cancer

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The compassion gambit

I’ve spent the last three weeks writing about a “brave maverick doctor” by the name of Stanislaw Burzynski who claims that he can cure cancers that regular oncologists cannot. He uses a combination of what he calls “antineoplastons” (which, it turns out, are more or less than the active metabolites of an orphan drug known as sodium phenylbutyrate) plus a very expensive cocktail of chemotherapy and targeted agents chosen in a haphazard fashion and thrown together with little rhyme or reason. This week, I had planned to move on. However, I felt that I had to mention the Burzynski saga because it provides me with the most appropriate segue to a topic I’ve been meaning to write about for a long time, possibly since this blog began. In fact, it’s about as perfect a framework as I can think of upon which to drape the points I want to make in this post.

What I will discuss is perhaps the most effective, devastating attack that proponents of quackery, woo, and nonsense aim at supporters of science-based medicine (SBM). As far as that is the case, it is not effective because it’s fact-based, evidence-based, or science-based. Far from it. Rather, it’s effective because it appeals to the emotions and very effectively demonizes SBM proponents to the point where they often have a hard time standing their ground when it is used. Sometimes, it preemptively prevents them from even speaking up in the first place. It’s a little tactic that I like to call the “compassion gambit,” which means trying to discredit critics of “alternative” medicine by painting them as cold, unfeeling, uncaring, arrogant monsters who want to hurt or kill children (and probably get a big smile on their faces when they torture puppies, to boot).
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Posted in: Cancer, Science and Medicine, Science and the Media, Vaccines

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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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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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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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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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“And one more thing” about Steve Jobs’ battle with cancer

I’ve written quite a bit about Steve Jobs in the wake of his death nearly four weeks ago. The reason, of course, is that the course of his cancer was of intense interest after it became public knowledge that he had cancer. In particular, what I most considered to be worth discussing was whether the nine month delay between Jobs’ diagnosis and his undergoing surgery for his pancreatic insulinoma might have been what did him in. I’ve made my position very clear on the issue, namely that, although Jobs certainly did himself no favors in delaying his surgery, it’s impossible to know whether and by how much he might have decreased his chances of surviving his cancer through his flirtation with woo. However much his medical reality distortion field might have mirrored his tech reality distortion field, my best guess was that Jobs probably only modestly decreased his chances of survival, if that. I also pointed out that, if more information came in that necessitated it I’d certainly reconsider my conclusions.

The other issue that’s irritated me is that the quackery apologists and quacks have been coming out of the woodwork, each claiming that if only Steve Jobs had subjected himself to this woo or taken this supplement, he’d still be alive today. Nicholas Gonzalez was first out of the gate with that particularly nasty, unfalsifiable form of fake sadness, but he wasn’t the only one. Recently Bill Sardi claimed that there are all sorts of “natural therapies” that could have helped Jobs, while Dr. Robert Wascher, MD, a surgical oncologist from California (who really should know better but apparently does not) claims that tumeric spice could have prevented or cured Steve Jobs’ cancer, although in all fairness he also pointed out that radical surgery is currently the only cure. Unfortunately, he also used the failure of chemotherapy to cure this kind of cancer as an excuse to call for being more “open-minded” to alternative therapies. Even Andrew Weil, apparently stung by the speculation that Jobs’ delay in surgery to pursue quackery might have contributed to his death, to tout how great he thinks integrative cancer care is.

Last week, Amazon.com finally delivered my copy of Walter Isaacson’s biography of Steve Jobs. I haven’t had a chance to read the whole thing yet, but, because of the intense interest in Jobs’ medical history, not to mention a desire on my part to see (1) if there were any new information there that would allow me to assess how accurate my previous commentary was and (2) information that would allow me to fill in the gaps in the story from the intense media coverage. So I couldn’t help myself. I skipped ahead to the chapters on his illness, of which there are three, entitled Round One, Round Two, and Round Three. Round One covers the initial diagnosis. Round Two deals with the recurrence of Jobs’ cancer and his liver transplant. Finally, Round Three deals with the final recurrence of Jobs’ cancer, his decline, and death.

Before I start, a warning: I’m going to discuss these issues in a fair amount of detail. If you want “medical spoilers,” don’t read any further. On the other hand, one spoiler I will mention is that there was surprisingly little here that wasn’t reported before; the only difference is that there is more detail. However, the details are informative.
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Posted in: Cancer, Nutrition, Science and the Media

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More Breast Cancer Awareness Month pseudoscience from (who else?) Joe Mercola

I have mixed emotions regarding Breast Cancer Awareness Month. On the one hand, I look forward to it because it provides us with a pretext to get out science-based messages about breast cancer and to highlight a lot of the cool science that we do at our cancer center. On the other hand, the quacks see an opportunity in Breast Cancer Awareness Month to spread their message too. That message, not surprisingly, generally involves attacking science-based modalities for the detection and treatment of breast cancer and promoting their “alternative” methods. For example, last year, Christiane Northrup promoted thermography as somehow being better than mammography for the early detection of breast cancer. It’s not. Yet there she is this year again, still promoting the same nonsense. In years past, I’ve seen people like Dennis Byrne promoting a link between abortion and breast cancer, a link that is not supported by science. I’ve seen the likes of Mike Adams claiming that Breast Cancer Awareness Month is nothing more than a conspiracy by the male-dominated “cancer industry” to keep women down and misinformation about “myths” of breast cancer while likening the “cancer industry” to Nazi extermination camp commanders and chemotherapy to Zyklon-B. I kid you not about that last part. Indeed, during October, I frequently get to look forward to images like this one (click for a larger image):

Or this one:
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Posted in: Basic Science, Cancer, Clinical Trials

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