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Posts Tagged Stanislaw Burzynski

USA Today versus Stanislaw Burzynski

This is an SBM public service announcement—with blogging! Think of it as a bonus post, and don’t forget to read Mark Crislip’s regular biweekly offering, as it’s about an article in Skeptical Inquirer that particularly irritated him—and me, as well. Because, as we all know, the world needs more Mark Crislip.

I’ve made no secret of how much I despise Stanislaw Burzynski, the self-proclaimed cancer doctor and medical researcher who has been treating patients with an unproven, unapproved chemotherapeutic agent since 1977, seemingly slithering around, under, over, and past all attempts to investigate him and shut him down. Indeed, just type his name in the search box of this blog, and you will see copious evidence of my disdain for the man. Over 37 years, Burzynski has become a hero to the cancer quackery industry, touted as the man who can cure incurable cancers that science-based medicine can’t, even though his treatment, antineoplastons, allegedly peptides isolated from blood and urine that normally keep cancer in check in healthy people, are by any reasonable definition chemotherapy. Indeed, they are toxic, with a number of side effects reported, the most common and dangerous of which being life-threatening hypernatremia (elevated sodium levels in the blood). All you have to do is to type Burzynski’s name into the search box of this blog, and you’ll find copious documentation of the abuses of patients, science, and clinical trials perpetrated by Stanislaw Burzynski and the cult of personality that has evolved around him. He’s even acquired his very own film propagandist, a credulous fellow named Eric Merola, who has made two astoundingly bad documentaries that are nothing more than unabashed hagiographies of the brave maverick doctor curing cancer where no one else can. They’re chock full of misinformation, pseudoscience, spin, and obvious emotional manipulation, and the first one at least, was very popular.

For the longest time, I’ve been hoping that major mainstream news organizations would take this story on. It’s happened from time to time, but until 2013 it hadn’t happened in a long time. Earlier this year, the BBC featured Burzynski in an episode of its long-running series Panorama. It was a mixed bag that took the fairly easy path of making it all about the patients and never really delved into what I believe to be the central mystery of the four-decade-long Stanislaw Burzynski story, and that’s how he’s managed to keep his medical license and register clinical trials right up until 2012. That was a disappointment, although much of the rest of the Panorama episode was very good. He still has his medical license, but as I’ve pointed out several times, the FDA placed a partial clinical hold on Burzynski’s antineoplaston phase II clinical trials back in the summer of 2012. A partial clinical hold means that no new patients could be enrolled, but patients already on them could continue to receive treatment. In 2012, apparently a child died on antineoplastons, and so a partial clinical hold was placed on the trials involving children. That clinical hold was extended to adults in January 2012, with much wailing and gnashing of teeth among Burzynski apologists, as the FDA investigated between January and March. We now know the results of that investigation, but we never knew much about how that partial clinical hold came about.

Now, thanks to Liz Szabo at USA Toda, we know from her article “Doctor accused of selling false hope to families“:
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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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Medical cranks: Why we fight

Never let it be said that I can’t match Mark Crislip in shameless self-promotion. The world might indeed need more Mark Crislip™, but I like to think that it needs a bit more David Gorski, too. So, in that spirit, here are the videos, recently released by the James Randi Educational Foundation, of Bob Blaskiewicz, myself, and some key SBM players that you’ve come to know and love. The first video is my talk at The Amazing Meeting in July about Stanislaw Burzynski, MD, PhD. It’s entitled Why We Fight (Part I): Stanislaw Burzynski Versus Science-Based Medicine. The second video is Bob Blaskiewicz, of Skeptical Humanities and The Other Burzynski Patient Group, It’s entitled, appropriately enough, Why We Fight (Part II): It’s All About the Patients. The third video is of the panel that followed to discuss Medical Cranks and Quacks. Enjoy!

Oh, and consider it a bit of a taste of what’s to come tomorrow…and don’t forget to pay attention to Bob Blaskiewicz’s plea at the end of his talk to contact him if you’re interested in becoming active. At TAM, he had a sign-up sheet that he discussed at around 21:06 in the video. Online, just mosey on over to The Other Burzynski Patient Group and contact Bob Blaskiewicz. We will very likely be asking you to help very soon.

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

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Cancer Treatment Centers of America: Revisiting the epitome of “integrative” cancer care

Three weeks ago, I mentioned in a post that the week of October 7 to 14 was declared by our very own United States Senate to be Naturopathic Medicine Week, which I declared unilaterally through my power as managing editor of Science-Based Medicine (for what that’s worth) to be Quackery Week. One wonders where the Senate found the time to consider and vote for S.Res.221, which reads:

S.Res.221 – A resolution designating the week of October 7 through October 13, 2013, as “Naturopathic Medicine Week” to recognize the value of naturopathic medicine in providing safe, effective, and affordable health care.

I know, I know, it probably took all of five minutes to consider and vote for this, thanks to Sen. Barbara Mikulski (D-MD), who sponsored it. In any case, as October 7 approached, I thought about how I could keep my promise to blog about naturopathy this week, and I came up with a way to do it. It’s a bit roundabout, but I think it fits. The idea derives from a discussion I was having a while back about one of my “favorite” hospitals, namely the Cancer Treatment Centers of America, in which a colleague of mine questioned why there were so many CTCA ads on NPR and why CTCA is sponsoring shows on PBS such as the upcoming The Emperor of All Maladies by Ken Burns. Although I can’t wait to see this particular series, I am a bit worried that the infiltration of quackademic medicine will make an appearance, given that CTCA is a major sponsor. (more…)

Posted in: Cancer, Homeopathy, Naturopathy

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When doctors betray their patients and science-based medicine for money

We spend a lot of time on this blog discussing failures of the medical system. Usually, we such discussions occur in the context of how unscientific practices and even outright quackery have managed to infiltrate what should be science-based medicine (SBM) in the form of so-called “complementary and alternative medicine” (CAM) or “integrative medicine,” in which the quackery of alternative medicine is “integrated” with SBM. Our attitude towards this practice is, of course, completely in tune with that of fellow SBM blogger Mark Crislip when he so famously wrote, “If you integrate fantasy with reality, you do not instantiate reality. If you mix cow pie with apple pie, it does not make the cow pie taste better; it makes the apple pie worse.” However, as grave a threat to SBM as CAM and integrative medicine are, there is a threat at least as grave here in the U.S. (and, I presume, in many places in the world). It has little or nothing to do directly with CAM, but often CAM practitioners benefit from it. What I am referring to is the utter ineffectiveness of most state medical boards in reining in quackery and bad physician behavior that endangers patients. A recent story about a prominent Detroit area oncologist named Farid Fata, MD, who has been arrested and charged with administering unnecessary chemotherapy and of diagnosing patients with cancer who turned out not to have cancer in order to defraud Medicare, has led me to think that now might be a good time to revisit this issue. Then I heard about an Ohio spine surgeon indicted for performing unnecessary surgeries to defraud insurance companies, and I knew that now is a good time to revisit the issue.

I’ve discussed this issue before with respect to various practitioners over the years. One that comes to mind immediately is Dr. Rolando Arafiles at the Winkler County Memorial Hospital in Kermit, TX. Basically, a CAM-friendly physician was practicing substandard medicine, and two nurses reported him anonymously to the Texas Medical Board. Dr. Arafiles was a business partner with Winkler County Sheriff Robert Roberts, who left no stone unturned to discover who had complained about his good buddy, leading to the prosecution of the two whistleblowing nurses for violation of patient privacy, even though Texas law explicitly said that using patient information to report substandard care is not a violation of patient privacy. The entire medical establishment seemed to be trying to come down on the two brave nurses like the proverbial ton of bricks. Ultimately, the Texas Medical Board did the right thing, but it took a long time, and two responsible nurses who couldn’t bear seeing Dr. Arafiles continue to betray patient trust. There are many other examples, such as that of Dr. Rashid Buttar, a North Carolina doctor known for using “alternative” treatments for autism and cancer who got off with a slap on the wrist for some truly horrendous violations of the standard of care.

And don’t even get me started on the utter failure of the Texas Medical Board to put a stop to Dr. Stanislaw Burzynski’s unethical abuse of clinical trials and use of an unproven cancer drug for over 36 years or on how it took decades to finally put a stop to Dr. Mark Geier’s autism quackery in the United States. So what about these recent cases have in common? It’s that they were both busted by the feds. The relevant state medical boards in Michigan and Ohio (both states in which I hold a medical license) did not detect the medical misadventures and did, as far as I can tell, basically nothing to stop it.
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Posted in: Health Fraud, Politics and Regulation

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Stanislaw Burzynski: The Early Years, part 1

It’s been a week now since I got back from TAM, where Bob Blaskiewicz and I tag-teamed a talk about a man who has become a frequent topic of this blog, namely Stanislaw Burzynski. I’ve been meaning to come back to the topic of Burzynski, but from a different angle. There hasn’t been much in the way of news lately other than the release of Eric Merola‘s most recent propaganda “documentary,” Burzynski: Cancer Is A Serious Business, Part 2, but, believe it or not, there remain lots of loose ends that I haven’t covered. This time around, the angle is this: How did Burzynski get his start? His is a story that goes back over 46 years, and in the beginning he seemed to be a promising young academic physician and a perfectly respectable researcher. So what happened? How did he evolve from a seemingly idealistic young Polish physician to what he has been for many years now?

I started to think about this when I was writing my post about “alternative cancer cures” circa 1979, because one of the three articles written by Gary Null and various coauthors that appeared in Penthouse magazine in the fall that year, The Suppression of Cancer Cures, was dedicated primarily to Stanislaw Burzynski and his “antineoplastons,” which at the time were new news, so to speak. However, Null’s article, even though it was contemporaneous with Burzynski’s having recently struck out on his own and started his own clinic, didn’t reveal everything that I was interested in learning. Actually, the more I read, the more I realize that no source really reveals everything that I want to know about that time period in the 1970s and early 1980s that produced the Stanislaw Burzynski that we know and don’t love today. Available sources all tend to be either pro-Burzynski, Burzynski himself, or vague in the extreme about what happened. Fortunately, my research for my TAM talk will serve multiple purposes. Since the talk was so brief and required me to cover 40+ years of history in a mere 20 minutes, there was a lot left out. I hate to let all that research go to waste; so I’m going to use it for an intermittent series of blog posts.
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Posted in: Cancer, Clinical Trials, Politics and Regulation

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Doing Eric Merola a favor…

Believe it or not, I’m going to do Eric Merola (who doesn’t particularly like me, to the point of thinking, apparently, that I’m a white supremacist who doesn’t like evidence but does like to eat puppies) a favor. Having been away at TAM and otherwise occupied hanging out with fellow skeptics and, more stressfully, getting ready to give a talk in front of as many as 1,000 people on Saturday, somehow I missed this. Well, actually, I didn’t miss it, but somehow I forgot to post it, even though it would have only take a few minutes. Then when I got home I still forgot to post it. Now there are only three days left (four, counting today) for me to do it; so I’d better get to it. My having forgotten to do this is particularly amazing given the subject of my main stage talk at TAM, our old buddy Stanislaw Burzynski. I’m even doing it as an extra “bonus” post on a day that I don’t usually post on SBM.

I wonder if Merola will appreciate the favor I’ve done him?

Eric Merola, as you recall, is a filmmaker who was responsible for two propaganda films about Stanislaw Burzynski, the dubious cancer doctor who has used “antineoplastons” to treat cancer without having published any decent clinical trial evidence that they do what he claims. Back in 2010, Merola released the first of a not-so-dynamic duo of films, the first of which was called Burzynski The Movie: Cancer Is A Serious Business (or B1, as I like to call it). The movie didn’t do much for a year or more, but then über-quack Joe Mercola promoted it, and somehow Eric Merola landed an interview with Dr. Oz on his radio show. The sequel, the slightly less pretentiously titled Burzynski: Cancer Is A Serious Business, Part 2 (or B2, as I like to call it), was then released June 1 on various pay-per-view modes. As has been pointed out, it’s no better than the first, and it features direct attacks on the skeptics who had the temerity to criticized Burzynski and Merola over the last couple of years.
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Posted in: Cancer, Science and the Media

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BBC Panorama investigates Stanislaw Burzynski

Last week, I reviewed a long-expected (and, to some extent, long-dreaded) documentary by Eric Merola, a filmmaker whose talent is inversely proportional to his yen for conspiracy, pseudoscience, and quackery. Through a quirk of fate that couldn’t have worked out better if I had planned it myself, a long-expected investigation of the Burzynski Clinic by the BBC aired on its venerable news program Panorama last Monday. It was entitled, appropriately enough, Cancer: Hope for Sale? Ever since learning that the BBC was working on this back in January or February, skeptics have been looking forward to it with a mixture of anticipation and dread, anticipation because we expected that the Panorama crew would “get it” (in the interests of full disclosure, I will mention that I was interviewed over the phone by a Panorama producer and exchanged e-mails to answer questions and suggestions), but a bit of dread because we feared the bane of all news reporting on issues of science and medicine: false balance.

So now that the report was finally aired, how was it? You can either watch it on iPlayer (if you’re in the UK) or on YouTube (if you’re not, assuming it’s still there):

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

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Stanislaw Burzynski: A deceptive propaganda movie versus an upcoming news report

Well, I’ve finally seen it, and it was even worse than I had feared.

After having heard of Eric Merola’s plan to make a sequel to his 2010 propaganda “documentary” about Stanislaw Burzynski, Burzynski The Movie: Cancer Is Serious Business, which I labeled a bad movie, bad medicine, and bad PR, I’ve finally actually seen the finished product, such as it is. Of course, during the months between when Eric Merola first offered me an “opportunity” to appear in the sequel based on my intense criticism of Burzynski’s science, abuse of the clinical trials process, and human subjects research ethics during the last 18 months or so, there has been intense speculation about what this movie would contain, particularly given how Merola’s publicity campaign involved demonizing skeptics, now rechristened by Merola as “The Skeptics,” a shadowy cabal of people apparently dedicated (according to Merola) to protecting big pharma and making sure that patients with deadly cancers don’t have access to Burzynski’s magic peptides, presumably cackling all the way to the bank to cash those big pharma checks.
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Posted in: Cancer, Clinical Trials, Science and the Media

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“Alternative” cancer cures in 1979: How little things have changed

Sometimes blogging topics arise from the strangest places. It’s true. For instance, although references to how tobacco causes cancer and the decades long denialist campaign by tobacco companies are not infrequently referenced in my blogging (particularly from supporters of highly dubious studies alleging a link between cell phone radiation and cancer and the ham-handed misuse of the analogy by antivaccinationists, who seem to think that vaccine companies engage in deceit on a scale similar to the deceptive practices of tobacco companies in “denying” that vaccines cause autism and all the other conditions, diseases, and horrors their fevered imaginations attribute to them), I’ve never really delved particularly deeply into one of the most useful repositories of documents on the topic that exists, namely the UCSF Legacy Tobacco Documents Library. Actually, the reason I started poking around there is not due to tobacco science, but because a fellow blogger mentioned to me that there were some articles and documents about Stanislaw Burzynski there dating back to the late 1970s. My curiosity was piqued.

As I explored, however, I learned that the documents there were not so much about Stanislaw Burzynski per se. In fact, they were more about the state of the underground “alternative cancer cures” industry in the late 1970s, which interested me greatly. The reason is that, when it comes to having delved so deeply into cancer quackery, I’m a relative newbie. Compared to, for example, Wally Sampson, Stephen Barrett, Peter Moran, or even Kimball Atwood, I’m inexperienced, having only noticed this phenomenon in a big way in the Usenet newsgroup misc.health.alternative back around 2001 or so, give or take a year. As a result, I don’t have the shared historical perspective that they do, mainly because I can only learn about that era from reading, studying, and talking to people who were active then. After all, in the late 1970s I was still in high school, and in the 1980s I was in college and medical school. There was no Internet (at least none that I had access to and that contained the wealth of easily accessible information to which we have become accustomed). In any case, in high school I had other interests, and throughout the 1980s I was too focused on getting an education and training to be a surgeon and researcher, a process that extended into the late 1990s. (Yes, it takes that long sometimes, particularly if you are masochistic enough to want to get a PhD, complete a general surgery residency, and do a fellowship in surgical oncology.)
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Posted in: Cancer, Health Fraud, History

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