Dec 03 2012
About a year ago, I became interested in a physician named Stanislaw Burzynski who has been treating cancer with compounds that he calls “antineoplastons” for over three decades without, in my opinion, ever having ever produced any compelling evidence that antineoplastons have significant anticancer activity. Although I had been vaguely aware of Burzynski and his activities, it was the first time that I had looked into them in a big way.
Having found very few skeptical, science-based takes on Burzynski and having noted that the Quackwatch entries on Burzynski (1, 2, 3) were hopelessly out of date, I wrote a trilogy of posts about him, starting with a review of an execrably bad movie made by a simultaneously credulous yet cynical independent writer, producer, and director named Eric Merola whose primary business, appropriately enough, is mainly marketing. The movie was Burzynski The Movie: Cancer Is A Serious Business, a “documentary” (and I’m being polite here) that I characterized at the time as a bad movie and bad P.R. In brief, I saw this movie as a hagiography, a propaganda film so ham-fisted that, if she were still alive, it would easily simultaneously make Leni Riefenstahl blush at its blatantness and feel nauseated how truly awful it was from a strictly film making standpoint. It was also chock full of highly dubious science, in particular Burzynski’s latest venture, which is to sell “personalized gene-targeted cancer therapy” similarly lacking in oncological insight, so much so that I observed at the time that it was as though Dr. Burzynski read a book called Personalized Cancer Therapy for Dummies and decided he is an expert in genomics-based tailoring of targeted therapies to individual cancer patients. Finally, I completed the trilogy by pointing out that lately Burzynski has been rebranding an orphan drug that showed mild to moderate promise as an anticancer therapy.
Since then, I haven’t commented much about Stanislaw Burzynski on this blog (although fans of a certain Plexiglass box of blinking lights know that I’ve written about him elsewhere), except to use him as an example of a physician gone horribly wrong and an utter incompetent when it comes to personalized therapy. In essence, Burzynski represents the potential dark side of personalized medicine in that, even though he has no skills or expertise necessary to navigate the complex and cutting-edge field, he nonetheless orders cancer profiling tests from a company whose tests don’t look that useful to me, “interprets” the results, and then orders up a witch’s brew of expensive, targeted agents with potentially synergistic toxicities that have not been validated as combination therapy. Basically, the way Burzynski puts together “personalized therapy” reminds me of Severus Snape mixing potions together at Hogwarts—with one big difference. Snape knew what he was doing and his potions worked. The same cannot be said of Burzynski, who from my perspective understands neither molecular biology, genomics, nor, let’s face it, cancer.
However, a lot has happened in the year since I last wrote specifically about Burzynski on this blog, particularly in November. First, the long and sadly ineffectual effort by the Texas Medical Board to strip Burzynski of his license has come to an ignominious end—for the Texas Medical Board. Second, an announcement by Eric Merola on the Burzynski Movie YouTube channel that he is going to be releasing another movie about Burzynski in early 2013, which, according to Merola, will be “picking up where the first internationally award-winning documentary left off.”
I can hardly wait. No, really. I can hardly wait. Such targets only come around maybe once every few years.
First, let’s look at how Burzynski in my opinion got away with murder.
The Texas Medical Board flails once again
Right before Thanksgiving, I learned from Patrick “Tim” Bolen that apparently Burzynski might have slithered away from justice yet again. The last time, his hearing in front of the Texas Medical Board to strip him of his license was postponed by various legal maneuvers. Bolen gloated about the failure of “skeptics” and cited a letter from Burzynski’s attorney Rick Jaffe:
On November 19, 2012, judges of the Texas State Office of Administrative Hearings dismissed the Texas Medical Board’s pending case against Dr. Burzynski. The investigation started by the board in 2008 involved Burzynski’s novel off-label use of combination gene targeted therapy. Early on, two medical board informal settlement panels found that the use of these combination drugs on the advanced cancer patients involved was within the standard of care. However, the Texas Medical Board refused to drop the case and instead filed a formal complaint against Dr. Burzynski alleging the same standard of care violations previously rejected by the board settlement panels. After two years of intense litigation, the case was set for trial in April 2012. However, a week before trial, the administrative law judges dismissed most of the charges against Dr. Burzynski which forced the Board to seek to adjourn the case to do some reevaluation. After the judges denied the Board’s attempt to reverse the previous partial dismissal of the case, the Board did more reevaluation and moved to dismiss the entire case. We didn’t oppose the motion and on November 19, 2012, the case was dismissed.
The cutting-edge, multi-agent gene targeted therapy devised by Dr. Burzynski which was at the heart of this proceeding is still being given at the clinic and is helping countless patients. The Burzynski Clinic thanks all of its supporters and wishes all a Happy Thanksgiving and thanks – Rick.
Certainly, the gloating by the likes of Patrick “Tim” Bolen and Burzynski’s lawyer shed no light on the question, nor did this triumphant screed by someone who calls herself Sarah the Healthy Economist:
Why has Dr. Burzynski been so relentlessly persecuted first by the United States Government and then the Texas Medical Board for so many years?
Follow the money my friends!
The multi-agent gene targeted therapy called Antineoplastons is a nothing short of a huge medical breakthrough that promises to completely shatter the cut, poison, burn Standard Of Care – surgery, chemotherapy and radiation treatment. When clinical trials are completed and Antineoplastons approved, it will be the first time in history that a single individual and not a pharmaceutical company holds the exclusive patent to manufacture and distribute these gene targeted medicines on the open market.
Uh, no. Antineoplastons don’t represent “multi-agent gene targeted therapy.” The person who wrote this bit of gloating is clearly too ignorant of what Burzynski actually does and claims to know that the “gene-targeted” therapy he claims to provide is not antineoplastons (although Burzynski somehow manages always to include antineoplastons in his concoctions). Nor is what Burzynski does anything that will “completely shatter” the current cancer treatment paradigm.
None of this stops the hyperbole, though:
Parents have particular reason to rejoice that the case against Dr. Burzynski has been dismissed. One form of childhood cancer – diffuse, intrinsic, childhood brainstem glioma for which conventional medicine has no cure has been cured by Antineoplastons (with dozens of others). [ANP - PubMed 2003] [ANP - PubMed 2006] [ANP - Cancer Therapy 2007] [Rad & other - PubMed 2008] [Chemo/Rad - PubMed 2005]
Congratulations Dr. Burzynski on this huge win against the foes that are attempting to silence you and stop your amazing work. The road ahead is still long until treatment with Antineoplastons is widely available to all Americans, but this recent victory brings a big one home for the little guy!
The heart of the case brought against Burzynski brought by the TMB was his off-label use of targeted therapies in treating cancer patients, or, as I’ve referred to it a couple of times already, “personalized therapy for dummies.” It is actually astounding to see the number of targeted drugs in the drug cocktails used by Burzynski. Not only was Burzynski using chemotherapy and a lot of it, but he was using some very expensive products of big pharma in a medically unsupportable manner. So let’s head over to the actual legal rulings. I do this, of course, with a bit of trepidation because, of course, I’m not a lawyer. However, even not being a lawyer, I think the reasons for the dismissal become fairly obvious by reading some of the motions and rulings. Plus I had input from a real lawyer, our very own Jann Bellamy.
So why was Buryznski’s case dismissed? To find out, you too can get the relevant PDFs if you wish, just by going to the Texas State Office of Administrative Hearings (SOAH) and, using a guest account, and searching for docket 503-11-1669. The “money filings” are ORDER NO. 12 – RULING ON RESPONDENTS MOTION FOR DISPOSITION, STAFFS SPECIAL EXCEPTIONS, AND MEMORIALIZING PARTIES STIPULATION OF FACTS and ORDER N O. 16 » GRANTING AND DENYING IN PART STAFFS MOTION FOR RECONSIDERTION OF ORDER NO. 12. Basically, the TMB had gone after Burzynski based on the doctrine of vicarious liability, which means in essence that the TMB was arguing that Burzynski was responsible for the actions of the physicians working for him who had cared for the patients at the heart of the TMB case against Burzynski. In response, Burzynski moved to dismiss and/or strike TMB allegations against him to the extent that the allegations were based on the actions of other physicians working at his clinic. His attorney’s argument was that, under administrative law, there is no vicarious liability for the actions of others. This is apparently different from tort law (for example, medical malpractice), where the physician can be held liable for the actions of physicians working under his control or supervision in some circumstances. The bottom line is that the administrative judge ruled in Burzynski’s favor. From the RESPONDENT’S REPLY TO THE BOARD STAFF’S SUPPLEMENTAL RESPONSE ON THE CONSOLIDATE MOTION FOR DISMISSAL AND SUMMARY DISPOSITION:
Respondent’s ownership of the clinic and his self-designation as the clinic’s chief physician on some forms, his ability to hire and fire everyone, and even that the forms which state that he is in “charge of treatment” (as stated in the informed consent forms for patient A) is only evidence of responsibility under vicarious liability theory, given the fact that the medical records detail exactly what doctors provided services to these two patients and who was involved in the delivery of medical care to these patients.
The judge accepted this reasoning, which meant that the TMB apparently faced the bad option of trying to prosecute a case based only on what the complaint alleged that Burzynski himself did. It’s not clear why the TMB voluntarily dismissed the case after this ruling, but perhaps the TMB’s lawyers concluded that there wasn’t a strong enough case based only on the allegations against only Burzynski. Basically, by throwing his fellow physicians working for him under the bus, Burzynski walks. Why do I say “throwing them under the bus”? Simple. The TMB could, if it so desired, begin actions against the individual physicians who took care of these patients, and I sincerely hope that the TMB does just that.
As for the significance of the ruling, contrary to what Burzynski’s apologists would like you to believe, this ruling says absolutely nothing about whether what Burzynski is doing is good science or not. It says exactly nothing about whether what Burzynski is doing is good medicine or not. It says even less about whether Burzynski’s clinical trials are ethical or not. All the board found was that, as a matter of law, the TMB couldn’t bring action against Burzynski on the basis of actions performed by doctors under his supervision. So it’s a non sequitur when someone like Patrick “Tim” Bolen exults that Burzynski’s somehow been vindicated, Sarah the Healthy Economist says “alternative cancer treatment wins big,” or Burzynski’s lawyer Richard Jaffe says something like, “The cutting-edge, multi-agent gene targeted therapy devised by Dr. Burzynski which was at the heart of this proceeding is still being given at the clinic and is helping countless patients.” Just because the judge ruled on a narrow point of law regarding whether specific allegations were admissible in a case against Burzynski says nothing about the validity of Burzynski’s work, nor does it in any way vindicate him. He got off on a technicality, and that’s all. It’s even sillier when someone like Jeffrey Phelps tries to spin the outcome of this case as evidence that cancer quacks ranging from Max Gerson to Royal Rife (and quite a few in between) must be on to something and that their rejection by the scientific community was unfounded.
That still leaves the claim by Jaffe that “two medical board informal settlement panels found that the use of these combination drugs on the advanced cancer patients involved was within the standard of care.” Unfortunately, we have no way of finding out what the settlement panels did or didn’t find because the proceedings of such panels are confidential, being as the name implies an attempt to see if the parties can settle the case prior to litigation. One notes that the board appears to have disagreed with Burzynski’s characterization of the settlement proceedings.
I’m not going to lie or downplay it here, though. The dismissal of the TMB action against Burzynski is a major setback to efforts to stop what Burzynski is doing. He’s now basically free to continue to do what he’s been doing for the last thirty years. Once burned, it’s unlikely that the TMB will take another crack at him any time soon. The last time it did was back in the 1990s. Will it be in the 2020s before a future board decides to try again, or will Burzynski retire or die before then, leaving his son Greg to carry on the family business?
Unfortunately, it’s clear that this ruling sets the stage for Burzynski II — or is it III? Given that Burzynski managed to slither away from justice back in the 1980s, when the TMB and the FDA were both on his case, making the current incarnation of Burzynski the second installment, although he didn’t get a such a willing sycophant to make a movie about him back then.
And now, Burzynski The Sequel: Even Burzynskier than the first movie!
Just yesterday, my Google Alerts did what the name implies and alerted me to a new development in the Burzynski saga. Meanwhile, a couple of Burzynski fans dropped some links on my blog, for instance this one from the Burzynski The Movie website:
For most patients being treated by the Burzynski Clinic today—their advanced cancer itself runs secondary to the constant barrage of skepticism coming not only from their local oncologists—who simply do not understand Burzynski’s therapy—but also from their own friends and family who feel their loved ones are not making the correct treatment decisions—even though mainstream oncology has already left many of them for dead.
As this story unfolds, the audience will witness a real-time change of hearts and minds from many doctors and families.
Unlike the first documentary, we have interviewed board-certified oncologists, surgeons, and neurosurgeons for this film who witnessed their patients leave their care to return in great health, after opting for the Burzynski Clinic.
Since the mapping of the Cancer Genome, Burzynski has pioneered an expansion of his therapy that he calls, “Personalized Gene-Targeted Cancer Therapy”, where each patient’s Genomic Cancer Atlas is mapped, and a treatment regimen is personally tailored for each individual patient—vs. the conveyor belt, “one size fits all” approach that current oncology adheres to. This part of the film will likely be the first time most of the audience will become aware of this new direction.
Due to the slow-moving bureaucratic obstacles of Antineoplastons by the FDA, this new expanded “personalized gene-targeted” direction has allowed more patients who are denied access to Antineoplastons by the FDA to benefit from Burzynski’s practice in ways never before thought possible.
Note the framing. There are those nasty skeptics, oncologists, and promoters of science-based medicine who, out of concern for patients going to the Burzynski Clinic, try to warn patients that Burzynski doesn’t have the goods. Merola will show them! He’ll do it using what are, in essence, religious conversion stories, in which the metaphorical St. Paul is knocked off his horse by the sheer awesomeness that is Burzynski, recants his previous skepticism as the “miracle” of antineoplastons and Burzynski’s “personalized” therapy is revealed, and becomes a believer. Notice, however, no mention of—oh, you know—scientific evidence.
It also looks as though Merola is going to amp up the conspiracy theory angle again. I’m not sure how he will achieve this, given that the first installment in Burzynski The Movie was one-third anecdotes, two-thirds broadsides against the FDA and the Texas Medical Board chock full of conspiracy theories. In any case, I’d love to see what Burzynski and his propagandist have to say about his “personalized gene-targeted cancer therapy for dummies”-approach to personalized cancer therapy, because from what I can tell on his website and publicly available sources, not only does Burzynski completely misunderstand targeted therapy, thinking that working on more genes must be better (here’s a hint: chemotherapy works on a lot of genes), but he misapplies very basic knowledge of genomics by using a “one from column A, two from column B”-style mixing and matching of targeted agents devoid of any deep understanding of the consequences.
Let’s take a look at the trailer:
The clip starts off with what is very old news, a press conference by the director of the FDA through much of the 1990s David Kessler, being asked at a press conference whether the process of expedited review introduced then for anticancer therapies would speed up the approval of antineoplastons. Clearly, the two reporters asking questions are believers, as they keep badgering Kessler after he says that he doesn’t want to focus on any single anticancer agent. We’re then told ominously that less than one year after this press conference America’s federal and state agencies lost a “fourteen year campaign attempting to permanently revoke Burzynski’s medical license” and declares that “Burzynski’s victory” resulted in the government abandoning its attempt to “hijack” these medicines. Merola also accuses the government of colluding with one of Burzynski’s own scientists to file patents on Burzynski’s therapies, listed as patent numbers 6037376, 5635532, 5852056, 5654333, 5661179, 5635533, 5843994, 5710178 (which is the same as 5843994), 5877213 (listed as a continuation of 779744, which was abandoned), and 5881124. Several of these appear to be redundant, being continuations or combinations of other patents. Be that as it may, the researcher to which Merola refers is Dvorit Samid, who is currently Vice President of Medical Affairs at Synta Pharmaceutical and was Section Chief Differentiation Control, National Cancer Institute/National Institutes of Health Division of Cancer Treatment from 1990 to 1995. These patents have mainly to do with phenylacetic acid, which was one compound that Burzynski referred to as AS-2.1, and derivatives mostly as anticancer or differentiation compounds in in vitro systems. One of these patents (5881124) has nothing to do with antineoplastons and is in fact an imaging patent. Maybe it’s a typo that Merola will fix before he releases his movie.
Be that as it may, the claim that Dvorit Samid “stole” Burzynski’s antineoplaston patents strikes me as rather questionable (at best), given that, first, Samid was not “one of Burynski’s scientists” but a section chief at the NCI. Also, using Merola’s counting methods, Burzynski himself has four patents on antineoplastons, issued in the 1980s. These include 4,470,970, 4,558,057, 4,559,325, and 4,444,890 and since the 1990s has filed numerous patent applications for antineoplastons for everything from treating cancer using liposomal delivery systems, to treating hypercholesterolemia and Parkinson’s disease. What exactly happened between Burzynski and the NCI is difficult to discover, as it is documented objectively in few places but trumpeted around the web by Burzynski-friendly sources. Even a paper analyzing the incident from a sociological standpoint isn’t particularly revealing, given that it, too, slants towards Burzynski and was published in a highly dubious journal.
Next up is a mention of Burzynski’s infamous phase III clinical trial, A Randomized Study of Antineoplaston Therapy vs. Temozolomide in Subjects With Recurrent and / or Progressive Optic Pathway Glioma. What has always been puzzling to me, ever since I became interested in Burzynski and his antineoplastons, is why Food and Drug Administration (FDA) not only continues to let Burzynski set up phase II clinical trial after phase II clinical trial, nearly all of which never accrue enough patients to publish. Indeed, if you search ClinicalTrials.gov for “Burzynski” or “antineoplaston,” exclude all the trials with “unknown” status, you’ll find the aforementioned phase III trial, a whole lot of trials with “unknown” status, and a trial unrelated to antineoplastons for which a man named Joseph Burzynski appears to be an investigator at one of the sites.
One notes that Burzynski’s phase III trial, although approved in December 2010, is not yet open to accrual, even though it was scheduled to begin accruing patients in December 2011. In any case, the reason that this is an issue is that Burzynski apologists have been pointing to this study as “evidence” that there must be something to antineoplastons, the rationale being that otherwise the FDA would not have given the trial the go-ahead. Given that there is no good clinical data published by Burzynski that I’ve been able to find to support a phase II clinical trial, this has puzzled me and other skeptics, at least one of whom suspects that, however he persuaded the FDA to approve this trial, it suits Dr. Burzynski just fine that it has not opened yet. It is a suspicion that I share. Think about it. This phase III trial is the biggest and most effective club that Burzynski apologists have to beat skeptics over the head with. If Burzynski actually started accruing to the trial, its results would, by law, have to be posted to ClinicalTrials.gov. An approved but not yet accruing trial is an infinitely better weapon than a trial that accrues and produces no results. It’s also interesting to note that this clinical trial includes chemotherapy.
As for the phase II trials, there are lots of trials listed as having “unknown” status (meaning that their status has not been verified in over two years) but still listed as being “open” as well. There are also several studies listed as “withdrawn.” It’s a total of 62 trials over the last 20 years or so, and not a single one of them, as far as I and others who have looked at them have ever been able to tell, has produced any useful evidence for the efficacy of antineoplaston therapy. Is it any wonder that many of us suspect that these “clinical trials” are shams designed to get around the orders of the Texas Medical Board back in the 1990s that prohibited Burzynski from using antineoplastons except within the context of being tested in clinical trials?
The rest of the trailer consists of nothing more than the usual Burzynski blather, anecdotes, this time bolstered with two conversion stories involving credulous oncologists who are now Burzynski believers.
The human toll
If there’s one thing that disturbs me most of all about Burzynski, it’s my perception of how he abuses the clinical trials process, something he does as blatantly, if not more so, than antivaccine “researchers.” In this, Burzynski arguably exceeds the worst excesses of big pharma in that big pharma does not charge patients to participate in its clinical trials. Experimental drugs and all nonstandard care and tests related to the clinical trials are paid for by the drug company or, in the case of clinical trials funded by the government, but the grants funding the trials. In contrast, Burzynski typically charges tens to hundreds of thousands of dollars to participate in his “clinical trials.” When big pharma abuses the clinical trials process it is rightfully called out by Burzynski apologists. But when Burzynski does things as bad, such as using a biased and useless institutional review board to oversee his “trials,” and even worse from an ethical standpoint, such as charging patients huge sums of money to buy drugs at pharmacies he owns and using them as a “human ATM,” he is the brave maverick doctor being persecuted by The Man because he has the “natural” cancer cure that “they” don’t want you to know about and is given gushing coverage in a book by Suzanne Somers. Ben Goldacre recently released a book castigating big pharma for misleading patients and doctors. Burzynski supporters give us Eric Merola and his propagandistic “documentaries.”
Josephine Jones has been maintaining a master list of blog posts about Burzynski, and there you can find, along with several of my posts, links to a whole bunch of posts about patients and families who, lured by the false hope of the Burzynski clinic, spent hundreds of thousands of dollars for his antineoplaston therapy. Often, such families, who come from all over the world to the Burzynski Clinic in Houston, undertake truly prodigious fundraising efforts to come up with the requisite cash, a significant proportion of which is due up front. Most famously, there was Billie Bainbridge, a British girl diagnosed with intrinsic pontine glioma in 2010 who became famous in the U.K. because her family managed to persuade several British celebrities to hold two charity concerts to pay for her treatment at the Burzynski Clinic. Indeed, it was critical looks by U.K. bloggers, including a U.K. teen named Rhys Morgan, that led to a flack from the Burzynski Clinic making crude, thuggish, vacuous and bizarre legal threats to silence Morgan, behavior that that got even more bizarre after Burzynski, embarrassed and none too pleased by the attention, cut him loose while issuing a classic “notpology.”
Unfortunately but not unexpectedly, Billie Bainbridge died last spring.
Unfortunately, there are many other patients like Billie, the main difference being that most of them can’t muster the star power that Billie’s family could:
- Brynlin Sanders, a four-year-old girl from Kansas who developed brainstem glioma. Her family held fundraisers, including one on New Year’s Eve that netted $50,000. Not surprisingly, Burzynski didn’t save her.
- Jesse Bessant, a two-year-old boy from New Zealand with an inoperable brainstem tumor whose family raised over $300,000 to take him to the Burzynski Clinic.
- Isabelle Tan, a young woman from Singapore with an inoperable brain tumor who went to the Burzynski Clinic.
- Chiane Cloete, a six-year-old girl from the U.K. with a rare brain tumor whose parents are raising £130,000 to take her to the Burzynski Clinic.
- Rachael Mackey, the most recent patient I am aware of, was a 28-year-old woman with an oligoastrocytoma. She underwent surgery to remove it, but it recurred, and the second time around the surgeons were not able to remove it all. She died on October 28. Bob Blaskiewicz over at Skeptical Humanities has started a Storify page that chronicles Rachael Mackey’s experiences with the Burzynski Clinic. It’s truly sad.
- Amelia Saunders, a four-year-old girl from the U.K. who suffers from a large inoperable brainstem astrocytoma. As of October 4, they reportedly have raised £249,776 to pay for Burzynski’s treatments.
In fairness, the patients who have died after seeking care from Stanislaw Burzynski would almost certainly have died anyway. However, when they go to Burzynski they end up being charged tens or hundreds of thousands of dollars unnecessarily for his antineoplaston therapy, for which there is no compelling evidence of efficacy, although there are a lot of questionable anecdotes. They end up facing enormous financial pressures, and many of the families of these patients hold fundraisers and try to generate publicity, the better to attract donors to give them the money that they have been led to believe is the only hope their loved ones have to survive. Yes, these patients uniformly all eventually die, as is unfortunately virtually inevitable given the nature of their disease, but there’s no evidence that Burzynski prolongs their lives or contributes to their quality of life. Worse, Burzynski extracts huge sums of money from their families for the “privilege” of being on one of his many dubious clinical trials, funded by kind-hearted strangers and fueled by Burzynski’s cult of personality.
In the wake of his victory against the TMB (and, let’s not kid ourselves, even though a judge’s ruling on a fine point of law says nothing about the validity of Burzynski’s methods, this is a massive victory for Burzynski, at least in the arena of public opinion), it looks as though 2013 is going to be a year of a renewed push by Burzynski to convince the public that he isn’t a quack. Certainly the TMB isn’t likely to touch him again any time soon, although we can still hope it will go after the doctors working for him. One wonders if it’s possible to get a skilled, high-powered investigative journalist from a major news organization to look into this story. For a while, ABC News seemed to be interested (a producer actually contacted me in April to see if I would be willing to appear on camera). Unfortunately, apparently its news crew lost interest after Burzynski’s hearing scheduled for April was postponed, because I never heard from this producer again. I hope another organization will step up to the plate.
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