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When urgency to cure beats research ethics, bad things happen

Editor’s note: Just for your edification, here’s a “bonus” post. True, you might have seen this recently elsewhere, but it’s so appropriate for SBM that I couldn’t resist sharing it with those of you who might not read the other source where this was published recently. :-)

I’ve written a lot about Stanislaw Burzynski and what I consider to be his unethical use and abuse of clinical trials. Before that, I used to regularly write about Mark Geier and his unethical use and abuse of IRBs and clinical trials. Both doctors use their own IRBs stacked with their own cronies to rubberstamp scientifically and ethically dubious studies. Mark Geier got away with it for years. Stanislaw Burzynski got away with it for decades and, apparently, is still getting away with it to some extent. (His IRB is chaired by an old Baylor crony of his from the 1970s, and he has been cited for numerous problems with his IRBs.) I’d like to contrast how their unethical research, in which Mark Geier and his son David subjected autistic children to chemical castration with Lupron to decrease testosterone levels and allegedly make mercury easier to chelate (to them mercury was bound by testosterone, something that doesn’t happen under physiological conditions but requires organic solvents) and Stanislaw Burzynski administered an unproven cancer chemotherapy (antineoplastons) to hundreds of patients over the years and charged them for it, compares to a recent case in the news.

The case has been mentioned by PZ Myers. It happened that it involves the same sort of tumors that Stanislaw Burzynski claims to be able to cure, namely brain tumors. It happened at the University of California Davis (UC Davis) and involved two very prominent neurosurgeons there, a former head of the department Dr. J. Paul Muizelaar and Dr. Rudolph J. Schrot, who were found to have violated university’s faculty code of conduct with their experimental work. When you read this part of the story, you’ll shiver. At least, I did:
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Posted in: Cancer, Clinical Trials, Medical Ethics

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Dr. Stanislaw Burzynski’s cancer “success” stories

The year 2012 was rung out and the year 2013 will be rung in by news that Eric Merola, propagandist for “brave maverick doctor” Stanislaw Burzynski who claims to have developed a cancer treatment far superior to current conventional science- and evidence-based cancer treatments, is releasing releasing a sequel to his wildly successful documentary (in the “alternative cancer” underground, that is) Burzynski The Movie: Cancer Is Serious Business. In fact, the sequel is coming out on DVD on March 5, and you can even preorder it now. I somehow doubt that Eric Merola will send me a screener DVD to review, but I did review the first movie because it easily falls into a genre that I like to refer to as medical propaganda movies, which are almost always made in support of dubious medical treatments. My mostly lame jokes about proposed titles aside (e.g., Burzynski II: Electric Boogaloo, Burzynski II: This Time It’s Peer-Reviewed, or even Burzynski II: Quack Harder), it’s very clear that in the wake of the Texas Medical Board’s decision to drop its case against Burzynski on a technicality, Burzynski and his very own Leni Riefenstahl named Eric Merola are planning on a huge publicity blitz, in which Burzynski will be portrayed as, yes, a “brave maverick doctor” whom “They” (as in the FDA, drug companies, and the Texas Medical Board, a.k.a “The Man”) tried to keep down but failed because he has The Natural Cure For Cancer “They” Don’t Want You Sheeple To Know About.

I come back to this again because Merola’s strategy for Burzynski II, as I pointed out, is going to involve “conversion stories” of oncologists who didn’t believe in Burzynski’s magic antineoplastons but do now, attacks on skeptics who have been critical of his work (like me), and, of course, testimonials for success stories. I don’t know how I missed this before, but what exactly that will mean in practice is actually spelled out pretty well in an installment of a video blog by a Burzynski patient named Hannah Bradley. Bradley became famous for her battle against a malignant brain tumor, her decision to go to the Burzynski Clinic, and the prodigious fundraising efforts of her partner Pete Cohen through their Team Hannah website and vlog. In this vlog, recorded on September 7, 2012, Pete and Hannah are happy because in their previous vlog of July 27, 2012, they reported that, after having received Dr. Burzynski’s antineoplaston treatment Hannah has had a “complete response,” and indeed the MRI scans shown in their movie, Hannah’s Anecdote, do appear to show just that (more on that later).

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Posted in: Cancer, Clinical Trials, Science and the Media

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Dr. Stanislaw Burzynski’s antineoplastons versus patients

Prelude: Doin’ the Antineoplaston Boogaloo with Eric Merola and Stanislaw Burzynski

In December I noted that Eric Merola, the “film maker” (and, given the quality of his work, I do use that term loosely) who was responsible for a movie that was such blatant propaganda that it would make Leni Riefenstahl blush were she still alive (Burzynski The Movie: Cancer Is Serious Business, in case anyone’s interested), was planning on releasing another propaganda “documentary” about Stanislaw Burzynski later this year. Merola decided to call it Burzynski: Cancer Is Serious Business, Chapter 2 | A Modern Story. Wondering what it is with Merola and the multiple subtitles, I had been hoping he would call the Burzynski sequel something like Burzynski The Movie II: This Time It’s Peer-Reviewed (except that it’s still not, not really, and I can’t take credit for that joke, as much as I wish I could) or Burzynski The Movie II: Even Burzynskier Than The First, or Burzynski The Movie II: Burzynski Harder. Mercifully, I doubt even Merola would call the film Burzynski II: Antineoplaston Boogaloo. (If you don’t get this last joke because you are either not from the US or are too young to remember, check out the Urban Dictionary.)

In any case, Merola named the sequel what he named it, and we can all look forward to yet another propaganda film chock full of conspiracy theories in which the FDA, Texas Medical Board, National Cancer Institute, and, for all I know, the CIA, FBI, and NSA are all out to get Merola’s heroic “brave maverick doctor,” along with a website full of a “sourced transcript” to be used by Burzynski minions and shills everywhere to attack any skeptic who dares to speak out. The only good thing about it, if you can call it that, is that I’m guaranteed material for at least one juicy blog post, at least as long as I can find a copy of Burzysnki II online, as I was able to do with Burzynski I, thanks to Mike Adams at NaturalNews.com and other “alternative sites” that were allowed to show the whole movie for a week or so before folks like Joe Mercola were allowed to feature the complete film on their websites indefinitely.

Maybe Eric Merola will send me a DVD review copy when the movie is released. Or maybe not.
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Posted in: Cancer, Clinical Trials

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The latest chapter in the seemingly never-ending saga of dichloroacetate as a cancer treatment

The road from an idea to a useful drug is a long one, and in cancer it is often particularly long. One reason is that to be able to tell whether a given treatment is effective against cancer often takes several years at a minimum, in order to determine if patients receiving the new treatment are surviving their disease longer than those who are not. Surrogate endpoints are usually not enough. Tumor shrinkage in response to a drug often does not correlate with prolongation of survival, although the converse (i.e., lack of tumor shrinkage in response to a new drug) does strongly correlate with failure of a treatment to prolong survival. In other words, effects observed on surrogate endpoints are not enough to judge whether a cancer therapy is working or not.

Three years ago, predating the existence of this blog by nearly a year, I became aware of a story that involved many of the issues in bringing a compound from the laboratory to the clinic. The case was unusual in that is is very rare to see the scientific process by which new drugs progress through the stages of cancer research, from concept to testing in cell culture to testing in animals to testing in humans challenged so strongly by patients themselves. The reason that this normally doesn’t occur is that new cancer treatments are almost always the product of either university-conducted research, pharmaceutical company-conducted research, or partnerships between the two. This case was markedly different in that it involved a chemical that was not only easy to synthesize, but cheap and long out of patent. Even more intriguing, it targeted a metabolic abnormality found in many cancer cells, an abnormality first described nearly 80 years before by Otto Warburg in 1928. This latter aspect of the drug gave it every appearance of a “rediscovery” of old wisdom that big pharma had ignored for 80 years, and that only added to its mystique.

The chemical was dichloroacetate (DCA), and three years ago it created a world-wide sensation. Last week, it created a sensation again, as breathless news reports once again overhyped its promise. Since I’ve been following the story since early 2007, I appear to be in as good a position as anyone to tell the story thus far and put the new findings into context. To begin that process, let’s head back to January 2007.
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Posted in: Cancer, Clinical Trials, Health Fraud

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