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.
What I didn’t tell you at the time (mainly because it hadn’t happened yet) is that Eric Merola himself contacted me to appear in Burzynski II. I kid you not. About a month ago, back in early December, out of the blue I got an e-mail from Merola. I responded, as you might imagine, skeptically, pointing out the blindingly obvious, namely that it would be very easy for Merola to edit me to look really bad. Indeed, I wouldn’t put it past him to try to light me from below, the way they did to William Shatner in that episode of Star Trek in which the transporter split James Kirk into two Kirks, a good Kirk and an evil Kirk. (Yes, it was the evil Kirk who got the under lighting.) Add a little heat on the location, and—voilà!—you have a sweaty, poorly lit Dr. Gorski looking even more disreputable than he normally does!
Merola returned with an offer in which he assured me that he would not be interviewing me, that I could say anything I want. Of course, the same problem applies. He could easily put my segment after images of children with brain tumors and parents railing at skeptics as cold, heartless bastards who want their children to die. Through the magic of creative editing, enter the cold, heartless bastard cast by the producer and director, to be torn apart elsewhere in the movie. No, it was obvious after consulting with trusted friends with more media experience than myself, as well as the media relations people where I work, all of whom agreed that I’d be crazy to do this, that I would in fact be very foolish to agree to Merola’s offer. Far be it from me to do something that my media relations people tell me would be a very bad idea to do; so I politely declined. If, however, there is a segment in Burzynski II attacking me, trying to make me look like some pharma shill loon, and then painting me as somehow cowardly (rather than rational) to have declined the opportunity to show up on Burzynski’s little infomercial, don’t be surprised and don’t forget: You heard it here first. It wouldn’t surprise me if there were, given that Merola actually contacted Bob Blaskiewicz’s place of employment to try to intimidate him into silence. No, I knew it wouldn’t be wise from the beginning, but my ego wouldn’t let me just say no right off the bat, which is what I should have done.
Mentioning Bob Blaskiewicz brings me to another development in the long-running Burzynski saga, and that’s a chance for some positive skeptical action to highlight what’s going on at the Burzynski Clinic. Indeed, because he’s spearheading this particular bit of skeptical activism is exactly why Merola targeted Bob Blaskiewicz for what I view as harassment at his place of employment. First, Bob set up a website that he called The Other Burzynski Patient Group, to counter the glowing testimonials and seemingly miracle cures found on The Burzynski Patient Group with examples of a more typical outcomes of Burzynski patients gathered from public sources and social media. In addition, he’s come up with a campaign to wish Dr. Burzynski a happy birthday this year, skeptic style:
In honor of Dr. Stanislaw Burzynski’s 70th birthday on January 23rd, 2013, the Skeptics for the Protection of Cancer Patients are fundraising for St. Jude Children’s Hospital. Our goal is to raise at least $30,000 by Burzynski’s birthday, the approximate cost of entering one of his clinical trials of antineoplaston therapy. On his birthday, we will deliver a present to the Clinic, a challenge to Dr. Burzynski to match the total sum donated by skeptics, science advocates, and others who value good research into devastating forms of childhood cancer. The more you give, the more we ask of Burzynski.
Please visit http://www.crowdrise.com/fightchildhoodcancer/ and donate to St. Jude, a fantastic organization that does not turn away patients who cannot pay.
As I’ve heard it said, if Burzynski actually agreed to do this and match whatever money is raised, it would be the only good thing he’s ever done for cancer patients in his entire miserable career. Of course, it’s impossible to shame a man who has no shame; so I doubt that Burzynski will match this generous gift. You can, however, help by donating or, if you are a blogger or podcaster, writing about the campaign and examining what Burzynski is doing for yourself. If you are a skeptic and support science-based medicine, it will be difficult to conclude anything differently than what I’ve concluded.
The time for comic relief in the form of my lame jokes is over. Let’s get serious and illustrate what I mean. Here is the latest sad tale I’ve learned about from the Burzynski Clinic. I started out light-hearted because Burzynski’s antics to promote himself can be quite funny at times, but the effect his clinic has on patients is anything but funny. It’s deadly serious.
The story of Seán Ó’Laighin
One thing that I regret about my “epic” trilogy of posts in late 2011 about the overblown claims, dubious science, and lack of any convincing clinical trial data to support the efficacy of Stanislaw Burzynski’s therapy is that I didn’t concentrate enough on the patients. The reason for that was because, at the time, I was very much interested in writing an updated scientific analysis of Burzynski’s claims. The QuackWatch entry on Burzynski and his “antineoplastons”, although containing useful material, was hopelessly out of date, so in reviewing Burzynski I I tried to update it. Most importantly, there was no information on Stanislaw Burzynski’s latest little project, namely hijacking the concept of personalized therapy based on gene expression profiles to do what he has referred to as “personalized gene-targeted cancer therapy.” So I wrote about that in order to point out that he was essentially doing “personalized cancer therapy for dummies” and that, contrary to his claims that his therapies are so much safer and less toxic, he was administering a lot of chemotherapy and expensive targeted agents. I plan to write more about that in the coming year, because I want to try to put it all together what it is that Burzynski is doing. Also, some Burzynski supporters have been sending me citations that (according to them) show that Burzynski has really and truly demonstrated that antineoplastons work! Finally, I noted that one of the antineoplastons that he had isolated was, in fact, an orphan drug known as sodium phenylbutyrate, which can be prescribed off-label.
A couple of weeks ago over the holidays, the Irish television station TG4 broadcast a report entitled Tar éis na Trialach (“After the Trial”) about a young man named Seán O’Laighin (also spelled Sean Lyne) who is celebrating his 21st birthday while battling an inoperable brainstem glioma. Part I of the 30 minute show can be found here and embedded below (note that part II will start playing automatically after a commercial at the end of part I):
It’s worth watching the whole thing. Even though most of it is in Irish, it does have subtitles. It’s a moving (and depressing) portrait of a young man who at age 19 was a talented hurler and nursing student with a promising career and his whole life ahead of him when he was diagnosed with an inoperable brainstem glioma. Shots of him as a boy (who really liked Eminem and Michael Jackson), as a vigorous and athletic young man, and as a student are interspersed with pictures of Seán in a wheelchair, having drugs infused, his family holding fundraisers to send him to the Burzynski Clinic, and, most poignantly, him sitting on the sidelines of a hurling pitch watching what I assume are his former teammates practice, himself no longer able to play because of the deterioration of his motor function to the point where he has difficulty walking. We learn that the first symptom that something was wrong was photophobia and difficulty learning to drive because he had trouble coordinating shifting and acceleration. He went to Beaumont Hospital, where a workup revealed that he had a mass in his brain accounting for his symptoms, and a biopsy of the mass revealed glioma. Seán was apparently given a prognosis of surviving approximately eight months to two years, and we see a shot of an oncologist named Dr. Aengus O’Marcaigh saying:
We can contain it with chemotherapy and/or radiation, but it’s incurable because it’s too dangerous to operate.
I’m sure that regular readers know what’s coming next, and it does. We see a shot of Seán’s mother, who tells viewers:
In the irish side, all really the talk was was of containment. And then we heard about Burzynski, and they offered the hope of a cure for us. Seán was only 19 so we decided to go for it.
Next is a very familiar story to those of us who have been following Burzynski. Treatment at the Burzynski Clinic easily runs into tens of thousands, if not hundreds of thousands, of dollars. Through a monumental effort, Seán’s family managed to raise €120,000 (which at today’s exchange rate is approximately $160,000) to go to Houston; so go to Houston they did. We see the video that appears to have been taken with an iPhone camera of the family, including Seán, his mother, his brother Tomás, and his sister Deirdre mugging for the camera in front of the Burzynski Clinic, overjoyed to be there because they think that this is Seán’s best hope for survival.
Although it grated me to hear the narrator describe antineoplaston therapy as “controversial” (it’s not controversial from a scientific standpoint; there’s no evidence that it works), I give the producers credit for making it very clear that antineoplastons have never been “granted a general license by the FDA,” and calling them in a relatively dismissive tone “just a trial drug.” Also to their credit, the producers point out that Burzynski has never submitted his drug for conventional randomized clinical trials, and indeed he hasn’t. Not really. As I’ve described before, after having claimed to have discovered these magical chemicals in the urine and to have discovered that they are endogenous natural inhibitors of cancer, Dr. Burzynski has set up a lot of preliminary phase I and II trials whose results he never seems to publish in the peer reviewed literature. Instead, he likes to publish case reports and minuscule patient series in journals that aren’t even indexed by PubMed. No wonder, as the narrator puts it, the “medical profession here in Ireland are completely against it [going to the Burzynski Clinic].” Unfortunately, that didn’t stop Seán’s family doctor from agreeing to oversee Seán’s care in Ireland, which the Burzynski Clinic requires before it will let someone return to his home country under his treatment.
It’s definitely an ethical dilemma for doctors like this, because monitoring someone like Seán as he undergoes antineoplaston therapy isn’t just a matter of making oneself available in case there are problems. It involves ordering MRIs and other tests, as well as ordering blood work three times a week. I can’t help but note that if as a physician you order blood tests on a patient you are obligated to follow up the results and act on them if they are abnormal. Given that, contrary to Burzynski’s claims, antineoplaston therapy is not “non-toxic,” there’s a not inconsequential chance that a patient like Seán will end up in the emergency room and need to be admitted at some point. Then it’s up to you to fix the hypernatremia that antineoplastons cause. (I couldn’t help but note that the concentration of the antineoplaston infusion listed on the bags was 300 g/L, or a 30 per cent solution. That’s mighty concentrated stuff! No wonder severe hypernatremia is a known adverse reaction to antineoplaston therapy.
Although I knew a lot about Burzynski and antineoplastons already, what Seán’s story taught me is just how difficult the treatment is that Burzynski puts his patients through. Fortunately for Seán, his mother is a registered nurse and was able to handle mixing up the solutions under sterile conditions, infusing them into his Hickman catheter, drawing the blood work, and in general being his around-the-clock private duty nurse. According to Seán’s sister, it takes his mother 45 minutes just to prepare the infusion by mixing up the antineoplaston solution. Meanwhile Seán’s father quit his job to help take care of him, as Seán quite understandably laments that he can’t take care of himself anymore and has a very hard time just doing routine activities of daily living. In fairness, Seán would still require much of this care even if he were not being cared for through the Burzynski Clinic, but certainly the intense labor that is required to mix up and administer the antineoplaston solution would not be necessary if he were not being treated by Burzynski, nor would the expenditure of €120,000 or the massive effort it took to raise that much money.
The last half of the show alternates between preparations by Seán and his family for his 21st birthday party, with his friend taking him shopping for clothes, his family bringing his sister back home to Ireland from San Francisco, where she lives now, to surprise him, and other preparations, and Seán undergoing an MRI to determine whether his tumor had responded to the several months of antineoplaston therapy he had been undergoing. Fortunately, for Seán, his results took a few days to come back, which meant that he could enjoy his birthday party without the devastating news that later came. Not only did his tumor fail to shrink, but it didn’t even stabilize. In fact, it grew by 35%. Since tumor growth is usually measured on a 2D image, that means in terms of volume, his tumor grew by as much as (1.35)3 = 2.46-fold. He was taken off the antineoplaston therapy and is next shown looking for other alternatives, with his doctors suggesting that he go on Aviston, which appears to be a different spelling of the word “Avastin” or an alternate trade name. Assuming that’s the case, this is not an unreasonable option, given that gliomas tend to undergo a lot of angiogenesis.
There are a number of things about this documentary that one can learn if one is involved in caner care and knowledgeable about Stanislaw Burzynski. First of all, I find it rather telling that no one from the Burzynski Clinic, not even Stanislaw Burzynski himself, apparently agreed to appear either on camera or via telephone interview. Burzynski loves media attention; you can tell when he’s on camera that he’s just eating up the attention. Indeed, from my perspective he’s an egomaniac, full of the arrogance of ignorance about things like personalized cancer therapy, prone to contemptuously dismissing and attacking anyone who has the temerity to question the Great and Powerful Burzynski. Indeed, he’s even taken credit for pioneering the concept of personalized cancer therapy based on genes and the concept that cancer is a genetic disease, claiming to have published a journal article about it 20 years ago, allegedly long before conventional scientists and oncologists even thought of it. The problem, of course, is that, as far as I can tell, he published no such paper and personalized therapy is a concept older than 20 years. Of course, Burzynski tends to clam up when questioned about patients who didn’t get better pursuing his treatment or from interviewers who are not likely to be sycophants, toadies, and lackeys (e.g., Eric Merola). Whenever he does agree to be interviewed by a real journalist, generally he can’t prevent himself from lashing out at critics and making grandiose nonsensical claims.
More importantly than no one from the Burzynski Clinic showing up, there’s the question of the clinical trial. Remember how, in the 1990s, the agreement between the Texas Medical Board and Stanislaw Burzynski that allowed him to keep his license stipulated that Burzynski:
- Cannot distribute unapproved drugs [like antineoplastons] in Texas
- Can distribute “antineoplastons” only to patients enrolled in FDA approved clinical trials, unless or until FDA approves his drugs for sale
- Cannot advertise “antineoplastons” for the treatment of cancer
- Must place a disclaimer to his website, promotional material and ads stating that the safety and effectiveness of “antineoplastons” have not been established
Interestingly, although in the Irish television show antineoplastons are described as “trial therapy,” we learn nothing of the actual clinical trial, nor do we hear any mention of informed consent, protocol documents, etc. I’d give my proverbial eye teeth to get a look at the informed consent, protocol documents, and the description of exactly which clinical trial into which Seán was enrolled. If you go to ClinicalTrials.gov and type in “antineoplaston” plus either “glioma” or “glioblastoma,” you’ll find 16 trials. Eliminating the trials for children or for which glioma is not the tumor type being studied, that leaves four trials:
- Antineoplaston Therapy in Treating Patients With Brain Stem Glioma. The status of this trial is unknown. The study start date was listed as 1998, and the database entry was last updated in 2008. Given that it is very unusual for a phase II clinical trial to remain open for 14 years, it’s hard not to assume that this trial is dormant or closed. A search of the trial number (NCT00003459) on PubMed shows no publications.
- Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas. Same as above, except that the last update was in 2009, and the study start date was in 1996. A search of PubMed for this clinical trial number (NCT00003473) was similarly negative.
- Antineoplaston Therapy in Treating Patients With Brain Tumors. Same as above. A PubMed search for clinical trial number NCT00003457 yields nothing.
- Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme. The same, except that it was last updated in 2008. A search for clinical trial number NCT00003456 yields no publications.
So what we have here are a bunch of phase II clinical trials, which are meant to be preliminary, all started in the 1990s, all with statuses on ClinicalTrials.gov listed as unknown, none having been updated in at least three or four years, and none, apparently, having been published in the peer-reviewed literature, at least not in a form linkable to their ClinicalTrials.gov number using PubMed. As the NCI states in its review of the evidence concerning antineoplastons and cancer:
Antineoplaston therapy has been studied as a complementary and alternative therapy for cancer. Case reports, phase I toxicity studies, and some phase II clinical studies examining the effectiveness of antineoplaston therapy have been published. For the most part, these publications have been authored by the developer of the therapy, Dr. Burzynski, in conjunction with his associates at the Burzynski Clinic. Although these studies often report remissions, other investigators have not been successful in duplicating these results.
Given that these are all case series, phase I studies, and non-randomized phase II studies, it’s hard to believe that the FDA would allow Burzynski to keep all his phase II studies open over 13 years, particularly in light of the inability of other investigators to replicate his reported complete remissions, but apparently it has. All of this brings up the question yet again: Which clinical trial was Seán enrolled in? Inquiring minds want to know! What “clinical trials” are all those other patients being enrolled on? Again, inquiring minds want to know! Finally, why doesn’t Burzynski offer Seán his “personalized gene-targeted cancer therapy.” It probably wouldn’t be that big a deal to get the blocks of tissue from Seán’s biopsy and have them analyzed. Yes, inquiring minds do want to know, because they have had a great deal of difficulty figuring out how Burzynski gets away with what he gets away with when it comes to his clinical trials.
The saddest part
Perhaps the saddest part of the show is the end, because it demonstrates how a person like Burzynski, by offering false hope, can tempt even highly intelligent people who would normally be skeptical of such claims. As I’ve said before, if I were facing a terminal disease like the Seán is facing, even I’m not entirely sure that someone like Burzynski couldn’t tempt me. I don’t want to die any more than Seán does. But that doesn’t change the insight into Burzynski’s hold on his patients, even when his antineoplastons don’t work. For instance, here’s Seán’s mother’s response to a question asking whether she thought going to Houston was a waste of time given that the antineoplastons didn’t work:
No, not at all because there was a girl that was there a month before us from England. She’s now tumor-free. If you didn’t try you wouldn’t know.
Of course, given Burzynski’s unreliability and his frequent misinterpretation of CT scans and MRIs, it’s impossible to know whether this girl truly is tumor-free or not. Burzynski has been known to give interpretations of MRI scans to families that are so wrong they’re not even wrong, as they say. For instance, in the case of Andy Cayon, Burzynski told him that his tumor had shrunk by 84% when it had not. It turns out that Burzynski had misinterpreted the MRI and measured the whole where part of the tumor had been removed, not the tumor itself. In essence, Burzynski misinterpreted the healing process from surgery as tumor shrinkage. Truly, Seán’s tumor must have grown so much that even Burzynski couldn’t spin it as somehow being a response to antineoplastons.
Similar to Cayon, in the case of another patient, Amelia Saunders, Burzynski told the parents that the cysts forming in her brainstem tumor meant that the antineoplaston therapy was working. Unfortunately, oncologists and surgeons like myself know that many solid tumors can outgrow their blood supply, such that the cells in the center of the tumor become ischemic due to low blood flow and die. This is something that is commonly seen in advanced solid malignancies. Tumors frequently, as they progress, evolve into a relatively thin rim of viable, growing cells surrounding a central area of necrotic tumor tissue. Sometimes, if you get into a tumor while trying to resect it, that necrotic cellular debris will squirt out like so much disgusting toothpaste out of a toothpaste tube. (We try to avoid this happening, as it means we didn’t get a good margin of normal tissue and can seed tumor cells.) In contrast, when tumors shrink due to chemotherapy or other treatment, they often shrink from the outside in (because that’s usually where the most rapidly proliferating cells are). True, they don’t always shrink that way and sometimes do have spread-out areas of necrosis, but that’s less characteristic. Of course, Amelia’s tumor wasn’t shrinking, which made it less likely that her cysts were due to treatment effect.
Fortunately, Amelia’s father, as much as he wanted to believe in Burzynski, was an intelligent man. He took the MRI to a real neuroradiologist at Great Ormond Street Hospital who told him the truth: Amelia’s tumor was progressing. Sadly, over the next few weeks, Amelia’s tumor progressed, and she died about a week ago. At least Amelia’s family had some time to try to come to terms with her impending death. How many of Burzynski’s patients and families are denied that?
Instead, Burzynski families and their patients often fall into the trap, like Seán’s sister:
I think with everything you do in life you will always have people who make negative remarks. One of my friends started telling me that she had heard bad things about Burzynski, and I just said, “Do you know what? I don’t want to hear it.” A positive mental attitude is so important. It’s so important to a person who is ill, to feel as if he has hope. To feel as if he has a reason to get out of bed in the morning.
The show concludes with an image of Seán sitting in his wheelchair, watching his ex-teammates practice hurling, and saying how after he is through with his cancer he wants so badly to get back to playing again. It’s a devastatingly poignant moment that increased my contempt for Stanislaw Burzynski and the false hope he gives cancer patients under the guise of research, often at the cost of hundreds of thousands of dollars borne by their families and friends.
How does he keep getting away with it? I don’t know. But I mean to find out if I can.
ADDENDUM: James Randi has recently posted an interview about his experience with science-based cancer treatment that’s worth checking out.