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Stanislaw Burzynski’s propaganda victory on antineoplastons: The FDA caves

Mark Crislip, founder of the Society for Science-Based Medicine, whose board of directors I’m proud to be serving on, an organization that you should join if you haven’t already, sometimes jokes that our logo should be an image of Sisyphus, the king of Ephyra whom Zeus punished by compelling him to roll an immense boulder up a hill. However, the boulder was enchanted and, as soon as Sisyphus reached the top, it would roll back down the hill. Sisyphus was thus forced to repeat this action throughout all eternity. The metaphor is obvious. Those of us who try to combat quackery and the infiltration of pseudoscience in medicine often feel a lot like Sisyphus. I always used to argue that, as amusing as it might be to have such a logo as an “in” joke, it’s far too much of a downer to inspire what SSBM wants to inspire: Action in the form of volunteers taking on projects, such as converting Quackwatch into a wiki and then continuously updating and adding to that wiki indefinitely. We have to believe that there is hope of someday succeeding. “Let’s push that boulder up a hill one more time!” does not exactly constitute an inspiring rally cry, although I can definitely understand the feeling at times the older I get and the longer I’ve been doing this. We can all appreciate gallows humor at times, and, besides, I’m not that pessimistic. I can’t afford to be.

Even so, I can understand the Sisyphus analogy right now with respect to an unfortunately frequent subject of this blog, the doctor in Houston who proclaims himself a cancer doctor, even though he has no formal training in medical oncology, isn’t even board-certified in internal medicine, the prerequisite for undertaking advanced training in medical oncology, and has no discernable training in clinical trials management. I’m referring, of course, to Stanislaw Burzynski, MD, PhD, the Polish doctor who since 1977 has been treating patients with substances that he has dubbed “antineoplastons” (ANPs). What are ANPs? Burzynski claimed to have discovered ANPs during his time at Baylor and described them as endogenous cancer-fighting chemicals in human blood and urine. Unfortunately, he soon became convinced that only he could develop them into an effective chemotherapy drug and left Baylor to administer ANPs to his own cancer patients. Patients flocked to him because he claimed to be able to cure cancers that conventional medicine can’t cure.

This led to a series of battles between Burzynski and various authorities, including the Texas Medical Board, the FDA, and various attorneys general, because of his use of ANPs, which are not and never have been FDA approved, as well as for various—shall we say?—issues with insurance companies. Ultimately, in the 1990s Burzynski beat the rap and effectively neutered the FDA’s case against him by submitting dozens of clinical trials to the FDA for approval, which, given how much pressure the FDA was under from Burzynski’s friends in high places (like Texas Representative Joe Barton), the FDA ended up approving. However, as Burzynski’s lawyer himself bragged, these clinical trials were shams designed to allow Burzynski to keep treating cancer patients, not clinical trials designed to produce any real evidence of efficacy. Not surprisingly, although Burzynski has published the odd case report or tiny case series, he has not yet published the full results of even a single one of his many phase II trials. There is, quite simply, no convincing evidence that ANPs have significant antitumor activity in vivo in humans, even after 37 years. Meanwhile, the FDA has found numerous examples of Burzynski’s abuse of clinical trials, failure to keep necessary data, and failure to protect human subjects, while exposés by BBC Panorama and Liz Szabo at USA TODAY have been most unflattering, revealing at least one dead child as a result of the toxicity of Burzynski’s drug and a pattern of minimizing and hiding reports of adverse reactions.
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Posted in: Cancer, Clinical Trials, Politics and Regulation

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The Burzynski Empire strikes back

You might have noticed that I was very pleased last Friday, very pleased indeed. Given the normal subject matter of this blog, in which we face a seemingly-unrelenting infiltration of pseudoscience and quackery into even the most hallowed halls of academic medicine, against which we seem to be fighting a mostly losing battle, having an opportunity to see such an excellent deconstruction of bad science and bad medicine in a large mainstream news outlet like USA TODAY is rare and gratifying. As you might recall, USA TODAY reporter Liz Szabo capped off a months-long investigation of Dr. Stanislaw Burzynski and his Burzynski Clinic with an excellent (and surprisingly long and detailed) report, complete with sidebars explaining why cancer experts don’t think that Burzysnki’s anecdotes are compelling evidence that his treatment, antineoplastons, has significant anticancer activity and a human interest story about patients whom Burzynski took to the cleaners. Most of this, of course, is no news to SBM readers, as I’ve been writing about Dr. Burzynski on a fairly regular basis for over two years now. It’s just amazing to see it all boiled down into three articles and ten short videos in the way that Szabo and USA TODAY did, to be read by millions, instead of the thousands who read this blog. Szabo also found out who the child was who died of hypernatremia due to antineoplastons in June 2012, a death that precipitated the partial clinical hold on Burzynski’s bogus clinical trials, about which both Liz Szabo and I have quoted Burzynski’s own lawyer, Richard Jaffe, from his memoir, first about Burzynski’s “wastebasket” trial, CAN-1:

As far as clinical trials go, it was a joke…it was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment. The FDA wanted all of Burzynski’s patients to be on an IND, so that’s what we did.

And Jaffe’s characterization of the six dozen phase II clinical trials that Burzynski submitted in the late 1990s was this:

A cancer clinic cannot survive on existing patients. It needs a constant flow of new patients. So in addition to getting the CAN-1 trial approved, we had to make sure Burzynski could treat new patients. Mindful that he would likely only get one chance to get them approved, Burzynski personally put together seventy-two protocols to treat every type of cancer the clinic had treated and everything Burzynski wanted to treat in the future…Miracle of miracles, all of Burzynski’s patients were now on FDA-approved clinical trials, and he would be able to treat almost any patient he would want to treat!

I’m just repeating those quotes again, because they can’t be emphasized enough. Quite frankly, if I were Burzynski, I’d fire Jaffe for having published such statements in his book. But that’s just me. In the meantime, let’s take a look at the counterattack and why Burzynski’s excuses regarding the deficiencies found in the FDA reports do not ring true.
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Posted in: Cancer, Clinical Trials, Science and the Media

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