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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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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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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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Revealed by the FDA: The results of the most recent inspection of the Burzynski Clinic

After posting the talks that Bob Blaskiewicz and I gave at TAM this year, I realized that it’s been a while since I’ve written about the topic of those talks, namely Stanislaw Burzynski, the Houston cancer doctor who inexplicably has been permitted to continue to administer an unproven cancer treatment to children with deadly brain cancers for nearly 37 years now. Beginning in 1977, when he left Baylor College of Medicine and opened up the Burzynski Clinic, Burzynski has administered a cancer therapy that he calls antineoplastons to patients. After nearly four decades and several dozen phase II clinical trials started, he has never published a completed phase II trial. The only evidence he’s published consists mainly of cell culture studies, case reports, and couple of preliminary reports of his phase II clinical trials. Of course, Burzynski’s lawyer, Richard Jaffe, even dismissively admitted that these clinical trials are designed solely to allow Burzynski to keep giving antineoplastons.

So Burzynski operated from the late 1990s until summer 2012, charging exorbitant “case management” fees to enroll patients in his clinical trials, working with a credulous filmmaker who wanted to make a movie about him—twice—and flouting regulations designed to protect human subjects involved in clinical trials. Meanwhile, he branched out to “personalized gene-targeted cancer therapy,” which he promoted through Suzanne Somers; to AminoCare, which is basically antineoplastons sold as an antiaging nostrum (or, as Burzynski puts it, a “genetic solution to aging“); and to selling an orphan drug as a “prodrug” for antineoplastons.

So what happened in the summer of 2012? Apparently, there was a treatment-related death of a child, which led the FDA to issue a partial clinical hold on the Burzynski Clinic that prevented him from enrolling any new children on his clinical trials, although he could keep treating existing patients and enroll new adult patients. That partial clinical hold was extended to adults in January 2013, at which time the FDA arrived at the Burzynski Clinic to investigate. It was an event that was included at the tail end of Eric Merola’s second propaganda film about Stanislaw Burzynski and represented as, in essence, jackbooted fascists trying to keep the cure for cancer from The People. None of this stops credulous reporters from writing misleading articles with titles like Young mother with brain cancer given just a year to live BEATS the disease and gets married after having controversial treatment in the US, which is a story about Laura Hymas, a woman whose good fortune is most likely not due to Burzynski. Not long before that, there was another credulous article featuring another Burzynski patient, Hannah Bradley, as one of four patients treated for cancer with alternative therapies who are allegedly doing well. Again, Hannah Bradley’s good fortune is highly unlikely to be due to Burzynski’s nostrums.

All of this is why those of us who follow Burzynski have been waiting with the proverbial bated breath to find out what the FDA concluded. Just before the government shutdown the first shoe dropped, when the FDA released a warning letter to the Burzynski Research Institute (BRI). Then last week, the second shoe dropped, when the FDA released the original forms describing its findings regarding the inspection. The findings are, to put it mildly, damning in the extreme. In fact, now, more than ever, I wonder how on earth Burzynski has been allowed to continue to run clinical trials—or even practice—for so long. The findings include massive deficiencies in the Burzynski institutional review board (IRB), the committee responsible for making sure that regulations designed to protect human subjects in research are adhered to.
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Posted in: Cancer, Clinical Trials, Medical Ethics, Politics and Regulation

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No, sugar pills won’t repel insects, and other consequences of regulating nonsense

As a group blog, Science-Based Medicine brings a variety of perspectives to issues of science in medicine. However we align around a few core principles which define what science-based medicine is, and how it should be practiced. One principle we emphasize is the importance of subjecting the evaluation of all health interventions and treatments to a single, science-based standard. One of the biggest successes of the alternative medicine industry, worldwide, has been the embedding of different regulatory standards for the evaluation and approval of so-called “non-drug” products such as supplements, herbal products, and non-scientific treatment systems like homeopathy or traditional Chinese medicine (TCM). The implications cannot be overstated: this different and lower standard is now so firmly entrenched in most health systems that few seem to question its rationale, or consider the consequences. As a practicing pharmacist I spent the first decade of my career working within this regulatory framework without ever stepping back to question why we regulate some products differently. I started reading, took the red pill, and here I am today. (more…)

Posted in: Homeopathy, Science and Medicine

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FDA approval of drugs and transparency in clinical trial results

ResearchBlogging.orgNote: The reason that I am posting today rather than my usual Monday slot is because the article I discuss here was embargoed until last night. Consequently, I asked Harriet if she would trade days with me this week, and she was kind enough to do so.

One thing that science relies on almost absolutely is transparency. Because one of the most important aspects of science is the testing of new results by other investigators to see if they hold up, the diligent recording of scientific results is critical, but even more important is the publication of results. Indeed, the most important peer review is not the peer review that occurs before publication. After all, that peer review usually consists of an editor and anywhere from one to four peer reviewers on average. Most articles that I have published were reviewed by two or three reviewers. No, the most important peer review is what occurs after a scientist’s results are published. Then, all interested scientists in the field who read the article can look for any weakness in methodology, data analysis, or interpretations. They can also attempt to replicate it, usually as a prelude to trying to build on it.

Arguably nowhere is this transparency quite as critical as in the world of clinical trials. The reason is that medications are approved on the basis of these trials; physicians choose treatments; and different medications become accepted as the standard of care. Physicians rely on these trials, as do regulatory bodies. Moreover, there is also the issue of publication bias. It is known that “positive” trials, trials in which the study medication or treatment is found to be either efficacious compared to a placebo or more efficacious than the older drug or treatment it is to replace, are more likely to be published. That is why, more and more, steps are being taken to assure that all clinical trial results are made publicly available. For example, federal law requires that all federally-funded clinical trials be registered at ClinicalTrials.gov at their inception, and peer-reviewed journals will not publish the results of a clinical trial if it hasn’t been registered there. Also, beginning September 27, 2008, the US Food and Drug Administration Amendments Act of 2007 (FDAAA) will require that clinical trials results be made publicly available on the Internet through an expanded “registry and results data bank,” described thusly. Under FDAAA, enrollment and outcomes data from trials of drugs, biologics, and devices (excluding phase I trials) must appear in an open repository associated with the trial’s registration, generally within a year of the trial’s completion, whether or not these results have been published. Although there are some practical issues over this law, for example determining how much information can be disseminated this way without constituting prior publication, which is normally a reason to disqualify a manuscript from publication.
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Posted in: Clinical Trials, Medical devices, Politics and Regulation, Science and Medicine

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