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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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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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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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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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Eric Merola’s conspiracy-mongering and more of Dr. Stanislaw Burzynski’s cancer “success” stories

About a month ago, Eric Merola screened his second movie about “brave maverick doctor” Stanislaw Burzynski, Burzynski: Cancer Is A Serious Business, Part 2 (henceforth referred to as “Burzynski II”), a screening that Brian Thompson and an unnamed colleague from the James Randi Educational Foundation (JREF) attended, took notes, and even managed to ask a question. At the time, I took advantage of Brian’s awesome commentary about his experience on the JREF Swift Blog, his copious notes, and my read on Eric Merola’s trailers for the movie, what he said in the first movie, and his own promotional material to write about how Merola dishonestly demonizes what he refers to as “The Skeptics” (i.e., us) and five major misconceptions about Burzynski, cancer, and skeptics promoted in Burzynski II, all with a heapin’ helpin’ of conspiracy mongering. In this post, I will delve into a little more detail about the fundamental intellectual dishonesty behind Eric Merola’s conspiracy mongering and discuss two of the cases being used to “prove” that Burzynski can cure cancer, mainly because they are appearing along with Merola on the publicity trail. Merola himself, thankfully (I guess) has allowed me to do this by posting an edited version of that original Q&A to YouTube:

In particular, note how everything I said in my previous post about what went on at the Q&A is verified, and, in fact, you now have the details. I will try to mention the specific time points to refer to as I go along. Also note that there is a segment at about the 47:45 mark in which JREF’s Brian Thompson (blurred out but still recognizable) speaks with the husband of one of Burzynski’s patients that is worth watching and that I will briefly discuss further into this post.
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Posted in: Cancer, Clinical Trials, Science and the Media

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Burzynski: Cancer Is A Serious Business, Part 2: Like the first Burzynski movie, only more so?

Film producer Eric Merola seems to think that there is a conspiracy of skeptics (whom he calls The Skeptics) who are fanatically hell-bent on harassing his hero, Brave Maverick Doctor Stanislaw Burzynski. According to his latest film Burzynski: Cancer Is A Serious Business, Part 2 (henceforth referred to as Burzynski II, to distinguish it from part 1, to which I will refer as Burzynski I), there is a shadowy cabal of Skeptics out there just waiting to swoop down on any Burzynski supporter who has the temerity to Tweet support for him, any cancer patient being treated by Burzynski who Tweets or blogs about it, and any cancer patient even thinking about going to the Burzynski Clinic. I know this because he’s made it very clear in the promotional materials of his movie that that’s what he thinks and that skeptics were going to be the main target of his “film making” in his latest hagiography devoted to Stanislaw Burzynski. Very clear indeed. And, given how ham-fisted he was in his conspiracy mongering in Burzynski I, I’d be lying if I didn’t admit that I was at least a little concerned, because Merola made an explicit promise to “name names.” So were some other skeptics. After all, Merola isn’t exactly known for intellectual honesty (or even talent) in film making. We expected a heavy duty sliming, and curiosity (not to mention concern over our reputations) made us very—shall we say?—curious about what Merola was going to say about us.

So it was with great interest that I learned that Burzynski II was going to be screened at a film festival in San Luis Obispo last weekend. Its DVD release having been delayed from March 5 to July 1, I had thought that my curiosity about the contents of the movie would probably have to wait, and it will, at least as far as seeing the movie. A review of the movie suggested dark insinuations about Burzynski critics abounded, but that was not enough. Fortunately, a small posse of skeptics, lead by the intrepid Brian Thompson, made posthaste for San Luis Obispo. When the reports and copious handwritten notes in perfect encoded reptilian script came back, however, I was faced with a problem. How does one review or discuss a movie second-hand? How does one report on a movie that one hasn’t seen, about which one has to trust the powers of observation (and not to mention the note taking capabilities) of someone else, no matter how well briefed beforehand about what to look for? I decided that there was only one thing to do, and that’s just to go ahead and do it. I realize that there are likely huge swaths of information missing, but I definitely got a flavor of the movie from Brian’s detailed account plus discussions, and a definite idea of how it is going to be promoted from what was reported to have been said during the Q&A. Then I’ll discuss each of these points, thus inflating the rather thin observations I have from our Skeptics into a real post. Unfortunately, more detail from me will have to wait until the official release of the movie, or until such a time as Merola tries to bring the movie to somewhere in my neck of the woods. (Wouldn’t that be amusing?)

So here are the five things I learned (secondhand) from the Burzynski II screening, thanks to The Skeptics.
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Posted in: Cancer, Clinical Trials, Science and the Media

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Three myths about Stanislaw Burzynski and The Skeptics

As I finished last week’s post, I promised myself that I wouldn’t write about Stanislaw Burzynski again this week. After all, counting this post I will have done 13 posts so far in 2013, and, counting this one, four of them will have been about Burzynski, and three out of the last five posts (three out of four, really, if we eliminate my blatant self-promotion for the talk I gave to the National Capital Area Skeptics over the weekend). It’s the same sort of thing that I sometimes comment about over at my not-so-super-secret other blog when seemingly all my posts are about the antivaccine movement for days at a time. Still, as Michael Corleone said in The Godfather, Part III (admittedly the weakest of the Godfather movies), “Just when I thought I was out…they pull me back in.” Except, I guess, that I never really was out and, as long as Burzynski’s propagandist is coming after skeptics, myself included, I’ve come to the reluctant conclusion that I can’t be out for a long time.

Besides, with the first screening of the Burzynski sequel, Burzynski: Cancer Is Serious Business, Part II (which I’ll simply call Burzynski II, given Eric Merola’s penchant for long titles with multiple subtitles) at the San Luis Obispo International Film Festival yesterday, it looks as though I will find myself on the receiving end of what, from what I can gather, will be a withering and deceptive campaign of personal attack directed against myself and other skeptics who are critical of Burzynski’s treatments and methods. Like Josephine Jones, I can’t help but admit to feeling a little trepidation over this. Meanwhile, given that the Burzynski movie is now finding its way out into the wild, I thought it would be worthwhile to compare the myth-making about Burzynski in the movie with reality. There are so many myths being perpetuated by Merola and Burzynski, so I thought I’d take on three of the most flagrant ones. At some point, once I know the nature of the attacks against me, I will have to respond to specific allegations. Unfortunately, that might not be possible until after the DVD release in July. However, for now, I hope to make this post a resource that takes on the most blatant examples of exaggeration, cherry picking, and spin likely to be in the movie. Hopefully after that I can leave this topic alone for a while and explore more of the big wide world of science-based medicine and offenses against it.
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Posted in: Cancer, Science and the Media

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Dr. Stanislaw Burzynski’s cancer “success” stories update: Why is the release of the Burzynski sequel being delayed?

It’s no secret that I happen to be on several mailing lists of groups or doctors whose dedication to science is—shall we say?—questionable. Of course, the reason I join such mailing lists is to keep my finger on the pulse of pseudoscience, so to speak. Between such lists and strategically selected Google Alerts (the latter of which appear to be failing me these days), I’m usually aware of potential blogging material fast on selected topics that have become my bailiwick on this blog. So it was that I became aware on Saturday of a development regarding the movie about Stanislaw Burzynski that was going to be released direct to DVD this week.

I wrote about this “documentary” a couple of weeks ago, because it had become pretty clear that a significant part of the movie will be dedicated to a PR counterattack (more like a smear job) on skeptics who have been critical of Burzynski, criticism that apparently goaded him to use a rather unhinged individual by the name of Marc Stephens to threaten skeptical bloggers who had written posts critical of Burzynski’s science (more appropriately, his lack of science), and his proclivity for charging patients huge amounts of money to be in clinical trials, a practice that is in general considered at best questionable. The brouhaha in the blogosphere led me to pay attention to Burzynski in a way that I hadn’t before. Sure, I had heard of him, but I hadn’t really delved deeply into his claims. That situation was rectified in late 2011, as I reviewed the first propaganda movie made about Burzynski by Eric Merola, Burzynski The Movie: Cancer Is Serious Business. As I delved deeper, I learned that Burzynski’s evidence for the anticancer efficacy of his “antineoplaston therapy” doesn’t hold up; that his “personalized gene-targeted cancer therapy” is anything but personalized or gene-targeted; and that he’s using an orphan drug now in what appears to me to be a strategy to bypass restrictions on his use of antineoplastons that he agreed to in a consent agreement with the Texas Attorney General back in 1998 that allow him only to use these drugs as part of a valid clinical trial.

So I awaited the approach of this week with a mixture of anticipation and trepidation; anticipation because I wanted to see what sort of bizarre new conspiracy theories (or new twists on old conspiracy theories) that Merola could weave, and trepidation because I don’t know how badly Merola will trash me (and people I know) in his movie and such attacks could cause me difficulties. Suffice to say, it looked very much as though Merola was going to resurrect Jake Crosby’s scurrilous attacks against me from three years ago. So it was with great surprise that I read this e-mail on Saturday morning, sent to the Burzynski Movie mailing list:

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

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Dr. Stanislaw Burzynski’s antineoplastons versus patients

Prelude: Doin’ the Antineoplaston Boogaloo with Eric Merola and Stanislaw Burzynski

In December I noted that Eric Merola, the “film maker” (and, given the quality of his work, I do use that term loosely) who was responsible for a movie that was such blatant propaganda that it would make Leni Riefenstahl blush were she still alive (Burzynski The Movie: Cancer Is Serious Business, in case anyone’s interested), was planning on releasing another propaganda “documentary” about Stanislaw Burzynski later this year. Merola decided to call it Burzynski: Cancer Is Serious Business, Chapter 2 | A Modern Story. Wondering what it is with Merola and the multiple subtitles, I had been hoping he would call the Burzynski sequel something like Burzynski The Movie II: This Time It’s Peer-Reviewed (except that it’s still not, not really, and I can’t take credit for that joke, as much as I wish I could) or Burzynski The Movie II: Even Burzynskier Than The First, or Burzynski The Movie II: Burzynski Harder. Mercifully, I doubt even Merola would call the film Burzynski II: Antineoplaston Boogaloo. (If you don’t get this last joke because you are either not from the US or are too young to remember, check out the Urban Dictionary.)

In any case, Merola named the sequel what he named it, and we can all look forward to yet another propaganda film chock full of conspiracy theories in which the FDA, Texas Medical Board, National Cancer Institute, and, for all I know, the CIA, FBI, and NSA are all out to get Merola’s heroic “brave maverick doctor,” along with a website full of a “sourced transcript” to be used by Burzynski minions and shills everywhere to attack any skeptic who dares to speak out. The only good thing about it, if you can call it that, is that I’m guaranteed material for at least one juicy blog post, at least as long as I can find a copy of Burzysnki II online, as I was able to do with Burzynski I, thanks to Mike Adams at NaturalNews.com and other “alternative sites” that were allowed to show the whole movie for a week or so before folks like Joe Mercola were allowed to feature the complete film on their websites indefinitely.

Maybe Eric Merola will send me a DVD review copy when the movie is released. Or maybe not.
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