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Posts Tagged Stanislaw Burzynski

The Texas Medical Board vs. Stanislaw Burzynski, 2014 edition

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As I begin this post, I’m on a miserably crowded, hot, stinky flight winging my way home from TAM. This puts me in the perfect mood to write about my bête noire to conquer all bêtes noires, namely Stanislaw Burzynski, the Polish expat doctor who claims to have much better results treating deadly brain cancers than conventional oncology, even though he is not an oncologist and has never even completed the prerequisite training for an oncology fellowship, namely an internal medicine residency. Actually, I don’t mean that in the way that you probably think I mean it. This time around, unlike the last time around, writing about Burzynski will put me in a better mood to endure being slapped into a sardine can in coach, barely able to move, barely able to type, but needing to get a blog post out on Monday.

If you remember, the last time I wrote about Burzynski, the Food and Drug Administration (FDA) had caved, and by “caved” I mean that it had lifted the partial clinical hold on Burzynski’s clinical trials. As is usual with the long and winding saga that is Burzynski, I feel compelled to give a brief review for any newbie who might encounter this post. Old hands at this story can skip ahead or just skim.

Two years ago, a child named Josia Cotto died of hypernatremia (elevated sodium level in the blood) due to receiving treatment for a brain tumor from the Burzynski Clinic using Burzynski’s “miracle drug” antineoplastons. Hypernatremia is a known complication of ANP treatment, and, as a result of this child’s death, the FDA put a partial clinical hold on Burzynski’s clinical trials for pediatric patients, which meant that he could continue to treat children already enrolled in his clinical trials but could not enroll any new patients. Six months later, this partial hold was extended to all of Burzynski’s clinical trials, and in early 2013 the FDA inspected the Burzynski Clinic and Burzynski Research Institute (BRI). (more…)

Posted in: Cancer, Clinical Trials, Politics and Regulation

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The Center for Inquiry weighs in on the FDA’s mishandling of Stanislaw Burzynski’s clinical trials

We interrupt our usually scheduled post for an important announcement. OK, we do nothing of the sort. Scott Gavura’s post will go live a little later this morning. In the meantime, here’s a public service announcement about a frequent topic of mine, Stanislaw Burzynski, that I’d like you to read.

As you recall, last week, the FDA inexplicably decided to lift the partial clinical hold on Stanislaw Burzynski’s bogus clinical trials of antineoplastons, which he’s used since the 1990s as a pretext to charge huge sums of money for “case management fees” to patients for a treatment whose efficacy he has never demonstrated. Yesterday, the Center for Inquiry laid in, and has sent a letter to legislators:

“We are frankly stunned to hear that the clinical hold against Dr. Burzynski has been lifted,” writes CFI in its letter. For decades, Dr. Burzynski and the Houston-based Burzynski Research Institute have been trafficking in unproven and scientifically baseless cancer treatments based on compounds known as antineoplastons, derived from human urine, which Burzynski claims — without evidence — can target and destroy cancer cells. He has taken advantage of desperate patients who are at their most vulnerable, and willing to pay any price.

After the death of a six-year-old patient in 2012, the FDA placed a hold on Burzynski’s trials with children, followed by a hold on trials with adults in 2013, prohibiting him from taking on new patients on whom he could experiment and from whom he could extract more money.

Over several decades, his clinic has proven it is unable to properly protect patient rights, adhere to basic ethical or scientific protocols, or even maintain correct patient records. It has also shown it is willing to exploit desperate cancer patients and their families, milking them out of enormous sums of money. But it has yet to show even a shred of evidence that its cancer treatments have any positive effect whatsoever.

“We struggle to see why the FDA continues to enable this deceptive, antiscientific, and unethical medical adventurism and profiteering, even for patients who are terminally ill,” writes CFI. “Given the behavior of Dr. Burzynski and the Burzynski Research Institute over the course of nearly three decades of failed research and trials, and in the face of a complete lack of scientific evidence demonstrating the efficacy of their expensive and dangerous antineoplaston treatment, we find the FDA’s decision perplexing and profoundly disturbing.”

The full text of the letter can be found here.

If only groups like the American Cancer Society would write similar letters. Cancer patients have been taken advantage of for nearly four decades, and Burzynski has made a mockery of the clinical trial process for nearly 20 years. It’s gone on way too long.

Posted in: Cancer, Clinical Trials, Politics and Regulation

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

It’s been a while since I wrote a substantive post for this blog about the Houston cancer doctor and Polish expat Stanislaw Burzynski who claims to have a fantastic treatment for cancer that blows away conventional treatment for cancers that are currently incurable. The time has come—and not for good reasons. The last time was primarily just a post announcing my article about Burzynski being published in Skeptical Inquirer. When last we saw Stanislaw Burzynski on this blog, it was a post that I hated to write, in which I noted that the Food and Drug Administration (FDA) had caved to patient and legislator pressure and allowed compassionate use exemptions (otherwise known as single patient INDs) to continue. The catch? Cynically, the FDA put a condition on its decision, specifically that no doctor associated with Burzynski nor Burzynski himself could administer the antineoplastons. This set off a mad scramble among Burzynski patients wanting ANPs to find a doctor willing to do all the paperwork and deal with Burzynski to administer ANPs. The family of one patient, McKenzie Lowe, managed to succeed.

It’s hard for me to believe that it’s been almost three years since I first started taking an interest in Burzynski. Three long years, but that’s less than one-twelfth the time that Burzynski has been actually been administering an unproven cancer treatment known as antineoplastons (ANPs), a drug that has not been FDA-approved, to patients, which he began doing in 1977. Yes, back when Burzynski got started administering ANPs to patients, I was just entering high school, the Internet as we know it did not exist yet (just a much smaller precursor), and disco ruled the music charts. It’s even harder for me to believe, given the way that Burzynski abuses clinical trial ethics and science, that I hadn’t paid much attention to him much earlier in my blogging career. After all, I’m a cancer surgeon, and here’s been this guy treating patients with advanced brain cancers using peptides that, according to Burzynski, do so much better against what are now incurable tumors than standard of care while charging huge sums of money to patients on “clinical trials.” It might be a cliché to quote the Dead this way, but what a long, strange trip it’s been. Because there has been a major development in this saga whose context you need to know to understand, I’m going to do a brief recap. Long-time regulars, feel free to skip the next couple of paragraphs, as they just try to bring people up to date and include a lot of links for background, or, if you haven’t already, read this summary of Burzynski’s history published earlier this year in Skeptical Inquirer. Newbies, listen up. Read the next two paragraphs. You need to know this to understand why I’m so unhappy. (more…)

Posted in: Cancer, Clinical Trials, Politics and Regulation

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How “they” view “us”

Over the weekend, I was perusing my Google Alerts, along with various blogs and news websites, looking for my weekly topic, when I noticed a disturbance in the pseudoscience Force. It’s a phenomenon I’ve noticed many times before, but, as far as I can tell, I haven’t actually blogged about it here, at least not specifically, although I have mentioned it, particularly in posts about Stanislaw Burzynski. I have, however, blogged about it over at my not-so-super-secret other blog, which means that some of the thoughts (if you can call them that) that I plan to lay down in this post will likely seem familiar to some of you, but I think this is an important enough topic that I should cover it here, too. As arrogant as I might sometimes seem, even I’m not so deluded as to think that the fraction of SBM readers who are regulars at my not-so-super-secret other blog is anything greater than a clear minority, and even for those of you for whom there’s overlap I’ll try to make things different enough to be interesting.

On Friday, Sharon Hill published a post over at Doubtful News entitled Chiropractors get their spine out of place over critique. It’s about how chiropractors have reacted to a post by Steve Salzberg over at Forbes entitled New Medicare Data Reveal Startling $496 Million Wasted On Chiropractors. Salzberg’s blog post was basically about just that, namely the amount of money billed Medicare by chiropractors, information that’s possible to obtain since the government released Medicare billing data for individual practitioners. Salzberg pointed out that half a billion dollars is a lot of money, more than twice as much as what is wasted every year on the National Center for Complementary and Alternative Medicine (NCCAM) and the National Cancer Institute’s Office of Cancer Complementary and Alternative Medicine (OCCAM). The result was rapid. Chiropractors swarmed, complaining to Forbes.com, and making the usual threats to sue, much as they actually did sue Simon Singh and, fortunately, saw their lawsuit blow up in their faces.

This, of course, can be looked upon as a purely mercenary protection of turf and livelihood not unlike how Daniel Kopans attacks any study that finds mammography to be less effective than thought (or even ineffective) in decreasing deaths from breast cancer. There is, however, a form of backlash against criticism of pseudoscience that is different and, when I first encountered it, more disturbing to deal with. It’s a level of pure, visceral hatred that is difficult to understand; that is, until you try to put yourself into your “enemy’s” shoes. Consider this post an exercise in doing just that, an exercise that will no doubt shock at least one of our readers.
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Posted in: Cancer, Chiropractic, Critical Thinking, Genetically modified organisms (GMOs), Science and the Media, Vaccines

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Bob and I are now published in Skeptical Inquirer

As regular readers know, I was quite happy that Skeptical Inquirer (SI) agreed to publish articles by Bob Blaskiewicz and myself about the highly dubious cancer doctor in Houston known as Stanislaw Burzynski. Indeed, Bob and I have been busily doing our best to promote it, appearing on various podcasts, including Point of Inquiry and, most recently, The Skeptics’ Guide to the Universe, where once again we’ve called on skeptics to help us put pressure on our elected officials to prevent Dr. Burzynski from continuing to take advantage of desperate cancer patients, many with incurable disease, particularly incurable brain cancers. It’s in this spirit that I write this uncharacteristically brief post.

My only disappointment thus far was that SI is still largely print-only, which meant that I could only expose our article to subscribers and urge nonsubscribers to pick up a copy (which, by the way, you can still do, as I believe the issue with Bob’s and my articles is still on the stands). Given that my article was designed to be a primer on Stanislaw Burzynski for skeptics, while Bob’s article was intended to make suggestions about what you as supporters of science-based medicine can do to try to protect cancer patients, I’m now happy to announce that SI has published both of our articles online:

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Posted in: Cancer, Politics and Regulation

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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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Eric Merola and Ralph Moss try to exhume the rotting corpse of Laetrile in a new movie

Note: Some of you have probably seen a different version of this post fairly recently. I have a grant deadline this week and just didn’t have time to come up with fresh material up to the standards of SBM. This left me with two choices: Post a “rerun” of an old post, or recycle something. I decided to recycle something for reasons explained in the first paragraph of this post.

As I was deciding what to write about this week, I realized that, surprisingly, there is precious little on Science-Based Medicine about the granddaddy of modern cancer quackery, Laetrile. Given that the final nails were placed in the coffin of the quackery that was Laetrile more than 30 years ago in the form of a clinical trial that didn’t show a hint of a whiff of benefit in cancer patients, many of our younger readers might not even know what Laetrile is. But, as I explained when I wrote about Stanislaw Burzynski’s early years in the 1970s, which happened to be they heyday of Laetrile, in cancer quackery everything old is eventually new again, and Laetrile is apparently soon to be new again. True, it’s never really disappeared completely, because, again, no matter how discredited a cancer quackery is, someone somewhere will keep selling it and some poor cancer patient somewhere will be taken in. In any case, it occurred to me that we at SBM have discussed the politics of Laetrile. Indeed, Kimball Atwood once referred to it as the “the most lucrative health fraud ever perpetrated in the United States.” Moreover, Kimball makes a convincing case that the Laetrile controversy was an important precursor that laid the groundwork for advocates of “alternative medicine”—or, as it later became known, “complementary and alternative medicine” (CAM) or “integrative medicine—to successfully lobby for the founding at the National Institutes of Health of what later was named the National Center for Complementary and Alternative Medicine (NCCAM). However, there didn’t appear to be a post dedicated to discussing Laetrile itself, and something happened last week that allows me to rectify that situation.

So how is Laetrile about to become new again? Remember our old buddy Eric Merola? He’s the guy who made two—count ‘em—two conspiracy-laden, misinformation-ridden, astonishingly bad bits of “great man” propaganda disguised as documentaries about a Houston cancer doctor peddling unproven cancer treatments and charging his patients tens and even hundreds of thousands of dollars for the privilege of being under his care while receiving this magic elixir, known as antineoplastons. Over the last several months, ever since he unleashed Burzynski: The Sequel on an unprepared and uninterested world, Merola has been hinting about his next project. Given Merola’s involvement in Zeitgeist: The Movie and his primary role in throwing together two hack propaganda pieces that were so blatantly worshipful of Burzynski that Leni Riefenstahl, were she still alive and able to see them, would have told Merola to cool it with the overheated hero worship and portrayal of his movie’s subject as a god-man a bit, I knew his next movie would be more of the same. I also knew it would not be about Burzynski.
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Posted in: Basic Science, Cancer, Clinical Trials, Politics and Regulation

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Stanislaw Burzynski: Using 1990s techniques to battle the FDA today

It figures that I couldn’t go three weeks into 2014 without the topic of Stanislaw Burzynski rearing its ugly head. I had hoped to make it to February or even beyond before feeling the gravitational tug of the wretched hive of ignominious and unethical behavior, but here we are, only 20 days into the new year. So be it.

2013 finished with serious setbacks for Stanislaw Burzynski and his unproven cancer treatment that he dubbed “antineoplastons” (ANPs) way back in the early 1970s. As you might recall, in November, two things happened. First, the FDA released its initial reports on its inspection of the Burzynski Clinic and Burzynski Research Institute (BRI) carried out from January to March 2013. They were damning in the extreme, pointing out the shoddy operating methods of the institutional review board (IRB) used by the BRI to approve and oversee Burzynski’s “clinical trials” (and I use the term loosely) of ANPs. Violations included using expedited approvals to review single patient protocols, something so far outside the purview of what the expedited approval process was intended for, namely approving minor tweaks to human subjects research protocols without requiring a full meeting of the IRB, that the FDA called Burzynski out for it. Other violations included failure to report serious adverse events (SAEs) and adverse events (AEs) to the FDA and/or the IRB, failure to follow proper informed consent procedures, failure to determine that risks to subjects were minimized and that risks to subjects were reasonable in relation to anticipated benefits, if any, and a lot of other violations, which are listed in my previous post on the subject. (more…)

Posted in: Cancer, Clinical Trials, Politics and Regulation

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The Skeptics for the Protection of Cancer Patients need your help

We at SBM don’t normally ask our readers for much, if anything, other than to read and for the subset of you who like to be active in the comments to have at it. However, given the story of Stanislaw Burzysnki, which I’ve been covering with frequent blog posts for over two years now, how could I not listen to the appeal of my friend and co-conspirator (note to Burzysnki fans: that “co-conspirator” bit was sarcasm) to take action in the wake of the USA TODAY story that ran two and a half weeks ago. Despite the disingenuousness of Burzynski’s response, unfortunately he’s still managing to find his way into legitimate scientific meetings.
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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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