Note: Orac is away somewhere warm recharging his Tarial cells for further science and skepticism. In the meantime, he is rerunning some of his favorite posts. Given that the blog seems to have been infiltrated with Burzynski trolls again and Eric Merola threatens to make a sequel to the execrable movie he made about Burzynski a couple of years ago, now seems a perfect time to rerun a post of Orac's from about a year ago. In fact, now might be a perfect time to rerun the whole trio, as Orac has been thinking he needs to do a major update and reanalysis, and where better to start than with the original analysis? Besides, at the very least, it'll annoy Burzynski fans and start showing up in Google searches again.
I've been thinking about the Holy Hand Grenade of Antioch. You remember the Holy Hand Grenade, don't you? It was in Monty Python and the Holy Grail, where a cleric goes on and on about how "three shall be the number thou shalt count, and the number of the counting shall be three. Four shalt thou not count, neither count thou two, excepting that thou then proceed to three."
Yesterday, I counted two and am now proceeding to three.
I figured that, after spending two posts on how Burzynski's minions and shills (in particular a man named Marc Stephens) have been making baseless legal threats against bloggers, I should talk a bit more about the evidence regarding Dr. Burzynski claims as evidence for the efficacy of his antineoplaston therapy, and a perfect way to do that is to take a closer look at another medical propaganda film, this one made to sing the praises of Dr. Burzynski as a brave maverick doctor curing cancer while The Man tries to keep him down (and, of course, let cancer patients die because they can't have access to the glory that is Dr. Burzynski).
I've never been shy about letting my readers know exactly what I think of certain medical propaganda movies. No one would ever confuse my reviews with those of Roger Ebert (mine tend to be a lot longer, for one thing, and concentrate on science much more than moviemaking), but I do sometimes subject myself to these movies when I can find a way to watch them online that doesn't cost me any money. I do so hate the thought of my money finding its way into the pockets of quackery supporters. A little more than a week ago, I deconstructed a blatantly anti-vaccine movie that's been making the rounds called The Greater Good, while before that I took on a movie (Simply Raw: Reversing Diabetes in 30 Days) that tried to convince its viewers that it's possible to cure type I diabetes with a raw vegan diet, dangerous advice if ever there was any. And who could forget the documentary paean to the cancer quackery known as Gerson protocol called The Beautiful Truth?
The appearance of a--shall we say?--fan of Dr. Stanislaw Burzynski to harass and threaten bloggers who criticized Dr. Burzynski's pseudoscientific and unproven anticancer therapy known as antineoplastons reminded me that there is another medical propaganda movie floating around out there. It appeared several months ago and started making the rounds of various film festivals over the summer. Since then, I've seen it pointed to as "proof" that Dr. Burzynski is not a cancer quack but rather a misunderstood genius who has discovered the cure for most cancers but has been persecuted by the FDA, the Texas Medical Board, and big pharma because his "natural" therapy supposedly endangers their hegemony and, above all, profits. I'm referring to a documentary film by writer/producer Eric Merola called Burzynski The Movie: Cancer Is Serious Business. Not surprisingly, quackery promoters like Joe Mercola and Mike Adams are singing the praises of this movie to high heaven. Indeed, Mike Adams is even hosting the movie in streaming form on his website. If you don't want to go to Adams' website, the movie is also available for free on YouTube:
[NOTE: The Documentary Channel has apparently asserted a copyright claim and forced YouTube to take the video down. The video, however, is still available at that other wretched hive of scum and quackery besides The Huffington Post, NaturalNews.tv.
Given that Marc Stephens seems to want to bring attention to Dr. Burzynski so badly, I thought that the least I could do is to oblige him by reviewing Burzynski The Movie and bringing what attention I can to it. In the process, I might even look into a couple of Burzynski's studies that I've read and found to be--well--lacking, to put it kindly. Is it my fault that the attention I mean to bring to Dr. Burzynski and what is in essence a one hour and forty-five minute commercial for the Burzynski Clinic and Burzynski Research Institute is not the sort of attention that Mr. Stephens wants? Well, actually, it is, but Burzynski certainly deserves a heapin' helpin' of not-so-Respectful Insolence, but, oddly enough, hasn't gotten it. One might even say, he's been Insolenopenic, if you know what I mean.
Of course, Orac can fix that.
A pledge is made
The first thing I wondered upon forcing myself to watch this movie, which, let me tell you, took some effort, was who Eric Merola is. Certainly, he's an incredibly credulous fellow, given how easily and hard he falls for various bad arguments and bad science put forth by Dr. Burzynski and a man who basically serves as Dr. Burzynski's costar in the movie, namely Dr. Julian Whitaker, a man who bills himself as an "alternative health pioneer." We've met Dr. Whitaker before, as he is also one of Suzanne Somer's physicians and was featured in her book Knockout. In Burzynski The Movie, Dr. Whitaker has his nose embedded so far up Dr. Burzynski's rectum that Dr. Burzynski wouldn't need a colonoscopy if Merola just strapped a light to Dr. Whitaker's face. We haven't, as far as I can remember, met Eric Merola before. In the movie's promotional materials, Merola is described as a freelance art director for many of the top Madison Avenue advertising agencies in New York who launched Merola Productions, a company that's done ads for a number of large companies and projects for various cable channels. According to Merola, the reason he wanted to do Burzynski The Movie because:
After spending over a decade immersed in all aspects of the media world, Eric became aware of Dr. Stanislaw Burzynski and realized his was a story that must be told. Having always been heavily influenced by the power of documentary films, he set out to direct and produce the story of Dr. Burzynski and his patients.
Personally, given Merola's background in advertising, I have to wonder whether Dr. Burzynski just hired Merola to make an infomercial. Merola claims the movie was his idea, but I have a hard time believing it. I suppose it's possible given that he is apparently steeped in cancer quackery books, but the end product of his work is so one-sided that it's a joke, and a bad one at that. Certainly this movie plays like one. There's even something very odd and disconcerting about the narration. It has an almost robotic quality about it, and the background music is uniformly ominous while the production values are definitely second rate. In addition, unlike even The Greater Good, which at least throws a few token scientists and skeptics in to argue the "other side" only to shoot them down, never is heard in this movie a skeptical word about Dr. Burzynski. The praise heaped on Burzynski and the venom poured on his critics get pretty tiring after a while. By the time the documentary's credits rolled, I was drained. That's definitely 1:48 h of my life that I'll never get back.
Basically, the movie is broken into two parts, an introductory section with three testimonials followed by the story of the "persecution" of Dr. Burzynski by the medical establishment. These testimonials are far more manipulative than even the testimonials featured in The Greater Good, because each of them are of the type that portrays doctors as sending a patient home to die; that is, until the "brave maverick doctor," (Stanislaw R. Burzynski, MD, PhD, of course) comes to the rescue with his unconventional and unproven therapy. These testimonials are, in essence, the best evidence the filmmaker can come up with to "prove" that Dr. Burzynski's "antineoplaston" therapy can cure cancer. Indeed, Merola makes this explicit right at the very beginning of the movie:
This is the story of a medical doctor and PhD biochemist who has discovered the genetic mechanism that can cure most human cancers. The opening 30 minutes of this film is designed to thoroughly establish this fact -- so the viewer can fully appreciate the events that follow it.
I watched, hoping to see evidence from science and clinical trials, but the only evidence presented to "thoroughly establish" that Burzynski "can cure most human cancers" consists not of clinical trials, not of animal studies, not of basic science. Rather, it consists of three testimonials that take up the first 30 minutes of the movie. The remaining tedious--and I do mean tedious, real tedious--hour-plus of the movie consists of one big, JFK-style conspiracy theory. Because of Burzynski's "miracle cure" for most cancers, known as "antineoplastons," if you believe Merola, the FDA, big pharma, and the cancer establishment want to put Burzynski out of business not to protect the public but rather to protect industry profits and FDA power. The rest of the movie is about the FDA, the NCI, the Texas Medical Board, and various other entities investigating, or, as the movie implies, persecuting this "brave maverick doctor" because he's found a cure for most kinds of cancer.
But has he?
Certainly all too many families seem to think he has. Indeed, a little over a week ago, a skeptical blogger whose work I admire, Andy Lewis, wrote a post about two charity concerts that a British performer named Peter Kay was doing to raise money to pay for the medical care of a four-year-old girl named Billie Bainbridge, who, tragically, has an inoperable and very rare brain tumor known as Diffuse Intrinsic Pontine Glioma (DIPG). Now, given that the UK has the NHS, which pays for the health care of its citizens, you might wonder why such spectacular sums of money (in this case, £200,000--I kid you not) would be needed for this child. It turns out that the money raised is to be used to take Billie to the Burzynski Clinic in Texas. This reminded me very much of a campaign I remember seeing two years ago for a woman with medullary thyroid cancer named Rene Louis, who, although she had health insurance, wanted to pursue Burzynski's methods, which her insurance quite correctly refused to pay for. In fact, it turns out that this is not an uncommon scenario for Burzynski patients, with patients like Louis or families like the Bainbridge or the Hofsess family, having been convinced that Burzynski is their only hope, going to the media and managing to get human interest stories written about their campaigns to raise money. Some, like Rene Louis or the Hofsess family, go so far as to set up charitable organizations to continue to raise money for others seeking Burzynski's treatment. Unfortunately, the "human interest" interest in these stories rarely mixes with a skeptical or science-based viewpoint, even though the more appropriate spin on such stories is to portray them as consumer issues. If only the spin on such stories was more like that of the story of Wayne Merritt!
For those of you who are unfamiliar with the woo that is antineoplaston therapy, I've written about it once before, and Quackwatch has more than one excellent summaries (here as well), as do the NCI website, the American Cancer Society, and others. The short version of the story behind antineoplastons is that there is no good basic science or clinical evidence to suggest that antineoplastons have any significant activity against cancer. Despite that fact, Burzynski has been able to administer them to patients for over 30 years, despite serious efforts by the Texas Medical Board to shut him down in the 1990s. Since then, he's operated under a consent decree that keeps him from administering medicines that are not FDA-approved except under the auspices of a clinical trial. So, as described above, Dr. Burzynski has lots of clinical trials and charges his patients lots of money for them. You think I'm exaggerating? Doubt no more. Here are the charges presented to a family seeking treatment for a member with bowel cancer:
- Physician review of all medical records before your consultation appointment: - $500 non-refundable payment to cover the cost of the physicians' and clinic's evaluation services.
- Amount due at the time of consultation is as follows:
- $1,000.00 - which covers the initial consultation appointment
- $4,000.00 - required for lab work - Dr. Burzynski will order our specific Genetic Tumor Markers test. Once Dr. Burzynski receives these results he will determine a personalized therapy which will best treat your cancer.
- After Dr Burzynski reviews results and determines your course of treatment a $10,000.00 deposit will be due to start basic treatment.
- Additional deposits for prescribed medications will be required due to the FDA just recently approving some of them. Their cost can be very high. That's why we do not know the exact cost for treatment until these medications have been prescribed. (Estimated deposit for these medications can range between $7,000.00 - $15,000.00).
- When you are discharged to go home the monthly deposit for basic treatment will range from $4,500 - $6,000, in addition to medications. From our experience, the treatment regimen may last between 4 to 12 months on average for the majority of our patients.
I'm starting to see now how Billie Bainbridge could need £200,000 fairly quickly, especially given that another blogger, Zeno, reports that there is also a $4,500 to $6,000 "monthly case management fee" charged to all patients at the Burzynski Cinic. He even appears to have photocopied an actual brochure from the clinic. Interesting how none of this information is locatable on the Burzynski Clinic website? What I found interesting is a table that Zeno posted from the brochure. I hope he doesn't mind my "borrowing" it:
Looking at the table, I noticed immediately that Dr. Burzynski says nothing about survival rates, only "objective response rates," which are not defined in a meaningful way. The pamphlet defines them as as anything from an "improvement" (defined as "decrease in size of the tumors, not confirmed yet by the second follow-up radiological measurement") to "complete disappearance of all signs of cancer," which is utter bollocks. There are standardized ways of measuring tumor response agreed upon by radiologists and oncologists, such as the RECIST criteria. Burzynski lumps all responses together in an oncologically meaningless way. Also remember, Burzynski often uses standard-of-care chemotherapy along with his antineoplastons; so we would expect some responses. The chart above, however, is virtually meaningless, if only for the simple reason that initial tumor response often doesn't correlate to overall survival, and overall survival is what we care about.
Meanwhile, Burzynski hasn't published any scientific papers in peer-reviewed journals (at least none indexed on PubMed) since 2006, and none of them in a halfway respectable journal since 2004. Instead, he appears to prefer to publish by press release, reporting results of nonrandomized, single-arm phase II trials and presenting abstracts, where the standard for acceptance is much much lower, comparing his single arm results to historical controls and previous trials, and concluding that his therapy works. A search of ClinicalTrials.gov demonstrates that over the last 20 years, Burzynski has had dozens of phase I and phase II clinical trials, ten of which are still open and only one of which is listed as completed. Overall, it's a crappy record, to have so many phase I and II trials over the last 15 or 20 years and so little to show for it in terms of publications from phase II trials and any compound progressing to a phase III trial. Only one phase III trial is listed, and it hasn't opened yet. That's a failure in my book. No drug company or researcher would keep doing trials of a drug (and, yes, antineoplastons are drugs when used this way) with such an abysmal track record. A drug company would give it up as unpromising, and a university researcher would soon find he could no longer secure funding for more trials.
Of course, a pattern has emerged over the years. Whenever Burzynski does a trial, the results come out as promising, with minimal or mild toxicity. When other researchers do a trial with his neoplastons, the results aren't nearly as promising; in fact, the results are pretty much always negative, and significant adverse reactions are observed. In both cases, huge amounts of antineoplaston, ranging from 0.33 g/kg/d to 7.95 g/kg/d, the latter of which is a mind-blowing amount of any chemical to pump into someone's body. In the late 1990s three well-respected oncologists reviewed Burzynski's clinical trial evidence and all agreed that:
- The protocols are poorly designed and data are not interpretable.
- The toxicities of the antineoplastons treatment are significant and life-threatening.
- The data do not justify making antineoplastons available under special exceptions.
- Burzynski is conducting more clinical trials than his data justify.
- Burzynski's claim that antineoplastons produce "stable disease," which he considers a positive result, runs counter to established rules for interpretation of clinical trials data.
- Withdrawal by patients described by Burzynski as having responded is unusual in the practice of medicine.
- If Burzynski wants to convince patients and physicians that his drug works, he will have to accept the established mechanisms of clinical trials.
The science just isn't there. Yet, like the Energizer Bunny, Dr. Burzynski keeps going and going and going and going.
When you don't have science, hit 'em with testimonials!
It's abundantly clear, that scientifically speaking, Burzynski just doesn't have the goods. So, in making a hagiography of Dr. Burzynski in celluloid form, what choice does Burzynski's shill Eric Merola have, other than to beat his audience over the head with testimonials? If you thought The Greater Good was bad in its emotionally manipulative use of testimonials, you ain't seen nothing yet. Burzynski The Movie takes such manipulativeness to a new level, starting out with three testimonials. These include Jodi Fenton, Jessica Ressel, and Kelsey Hill. It turns out that jli has done an capable analysis of the three testimonials in this movie. As a cancer surgeon and researcher, however, I feel have something to add of my own, particularly in terms of clinical cancer treatment. In particular, I like to view these three testimonials as the three strikes that put Dr. Burzynski out.
As a medical professional, the first thing I noticed about these medical reports is that they have the definite air of having been cherry-picked. Certainly the reports included represent a highly selected subset of these patients' medical records, mainly just a series of radiology and pathology reports, and in one of them a key pathology report is missing. In the movie, little snippets of these reports, key parts of the text highlighted in yellow, are rapidly flashed onscreen, after which they disappear, all of which is designed to draw the viewer's attention to what the filmmaker wants, as jli points out in the case of Jodi Fenton. In Ms. Fenton's medical records two observations are most important to me. First, it is reported that there is no mass effect, compression of the ventricles, or midline shift, all of which imply that this mass was probably fairly slow growing. Second, a growth curve based on serial MRI tests is presented that is most curious. The pre-biopsy imaging suggests that the tumor is around 2 cm in diameter. However, the following table begins on 6/1/2000, which is two weeks after Fenton underwent a stereotactic biopsy of her lesion:
Notice something? The tumor's maximum diameter is now 0.5 cm, which is less than one-quarter what was reported. Given that tumor volume is proportional to the cube of the radius, that means that the tumor volume two weeks after her biopsy was roughly 64-fold (or more) smaller than it was before the biopsy. What's interesting is that then the residual tumor disappears within a month. It's highly unusual for chemotherapy (and, make no mistake, antineoplastons are chemotherapy) to shrink a tumor that fast. This brings up an intriguing possibility, mainly that the bulk of the tumor was removed by the biopsy process. I'm not a neurosurgeon, but I've seen the same sort of thing happen occasionally in small breast cancers that undergo a core needle biopsy, especially using a large biopsy needle; so it's not inconceivable to me that the same thing might happen in brain tumors. Whether such a thing is possible or not, it should also be noted that anaplastic astrocytomas can have a highly variable prognosis and growth rate, which means that Fenton's prognosis might not have been as bad as portrayed in the movie.
So what happened here? It's clear that this case was presented first because the film's producers thought this was their strongest case, mainly because the patient hadn't undergone any therapy before being treated with antineoplastons. So one of three things happened:
- The biopsy removed the cancer, and what was left behind was an inflammatory reaction.
- The biopsy removed much of the cancer, and antineoplastons worked on the rest
- Fenton is an outlier whose tumor regressed on its own
If Burzynski had real evidence that his therapy worked (i.e., clinical trial evidence), then he wouldn't be resorting to anecdotes like this one, which doesn't show conclusively that it was the antineoplastons that eliminated the tumor.
The second case was Jessica Ressel, who was diagnosed with a diffuse brainstem glioma in 1996. One thing that I noticed right away in perusing the records included with the film is that there is no pathology report. I found this rather curious, given that the pathology report was included in the last case. I also found the actual MRI view included in the report to be odd as well. See what I mean:
Do you see what bothers me? I'll give you a hint: there shouldn't be any yellow in this MRI scan. The authors obviously marked the area of abnormality with the same yellow marker that was used elsewhere. Trying to look under the yellow mark to see the most important parts of the scan, I don't see anything "diffuse" about that glioma; it looks pretty well encapsulated. Unlike the definition of a diffuse brainstem glioma, it doesn't take up anywhere near 50% of the brainstem diameter, although the yellow marking does conspire to make it look larger.
More importantly, looking at the tables tracking tumor volume, I see another problem, mainly that the volume of the enhancing lesion is all over the place, jumping up and down for several months. In fact, it takes the tumor over a year to disappear, and it doesn't even start to shrink consistently until nearly nine months after antineoplaston treatment started. This sort of behavior is strongly suggestive to me that the treatment probably had little to do with the disappearance of the mass, as drugs that are active against a tumor generally result in measurable shrinkage a lot faster than that and the tumor actually increased in size for a while during antineoplaston therapy. Moreover, the changes in tumor size don't appear to correlate very well to the changes in dosage. After all, if the tumor shrank significantly on the MRI of September 21 and Burzynski attributes that to doubling the dose of antineoplastons, then how does he explain the tumor size increasing significantly again on the November 11 scan? In any case, the behavior of this tumor makes me wonder about the diagnosis, which makes me wonder why the pathology report isn't included, as it was for the other two testimonials. Could it be that there was no biopsy of this tumor? If that's the case, then there are many reasons to doubt that this was ever a brainstem glioma in the first place, first, because its behavior was not consistent with one and, second, because brainstem tumors are heterogeneous and even highly suspicious lesions on MRI can be benign 13% of the time.
Strike two! Testimonial number two proves little or nothing.
If Burzynski had real evidence that his therapy worked (i.e., clinical trial evidence), then he wouldn't be resorting to anecdotes like this one, which doesn't show conclusively that it was the antineoplastons that eliminated the tumor.
The last patient is Kelsy Hill. Basically, at age 6 months, Hill was diagnosed with a baseball-sized tumor in her abdomen, which, according to the parents was in her kidneys, as well as in her liver and lungs. She was operated on, and a mass was removed, as described on this pathology report. What was initially curious to me about this particular testimonial is the question of why a surgeon would have operated if the baby already had liver and lung metastases at the time of diagnosis. The only reason to operate in the presence of lung metastases that I could think of would be if the surgeon thought he was going after a neuroblastoma, which is not an unreasonable assumption, particularly if the adrenal cortical carcinoma was nonfunctioning. Neuroblastoma is a childhood tumor that presents as a rapidly growing abdominal mass, but even when there are metastases it is often still potentially curable. It's also the most common cancer in infancy. Consequently, an infant presenting with a large abdominal mass and metastases is often considered to have neuroblastoma until proven otherwise, although the presence of lung metastases is more consistent with an adrenal cortical carcinoma. Finally, there is the issue of whether the child had an adrenal cortical carcinoma or adenoma. The former is malignant; the latter is benign, and it's not always easy to differentiate the two. The parts of the pathology report with special stains that can help differentiate between the two are missing.
More puzzling is, again, the behavior of the multiple liver and lung masses noted in the supplemental data. First, the raw data presented don't match the parents' description in that there are no liver masses noted until 2/22/2006, which is nearly six months after the initial surgery. It's also inconsistent with the narration of the movie:
Upon the removal of Kelsey's left kidney and left adrenal gland, her diagnosis was confirmed at the University of Texas Medical Branch, and again at M.D. Anderson cancer center. Where, a month later, M.D. Anderson also confirmed that Kelsey's cancer had spread to her lungs. After desperately researching Kelsey's situation, her family decided to decline all chemotherapy treatments offered my M.D. Anderson, and instead, enroll Kelsey into one of Dr. Burzynski's clinical trials. By this time, Kelsey's cancer had also spread into her liver.
Again, Kelsy's surgery was in September 2005; no evidence of liver metastases appears to have been noted until February 2006. When did she start the antineoplaston therapy? Was it shortly after surgery? If that's the case, then her liver lesions developed and her lung lesions grew while she was on the antineoplaston therapy. Or did she not start antineoplastons until the appearance of liver lesions in February? If that's the case, then why did her doctors leave her untreated for five months while her lung masses increased in size? No, what seems most likely is that antineoplaston treatment began soon after surgery, Kelsy's tumors grew for several months after that, and new liver lesions appeared while she was on therapy. Of course, it's not even clear if these lesions were metastases because there's no evidence that Burzynski or Kelsy's other doctors ever biopsied any of them. Again, there are no pathology reports of core needle biopsies of the suspected metastases.
Strike Three! Burzynski's out!
If you can't keep your pledge about the evidence, hit 'em with conspiracies and bad science!
Merola's pledge that the the opening 30 minutes of the movie would "thoroughly establish" that Burzynski has discovered the genetic mechanism that can cure most cancers was clearly not kept. These three testimonials do not constitute convincing evidence that antineoplastons can cure cancer. Given that they are almost certainly the absolute best cases that Burzynski could come up with, I'm forced to wonder what the denominator was. How many patients were treated with antineoplastons and didn't exhibit results even this good? Thousands upon thousands. Meanwhile, interspersed throughout these testimonials are comparisons of Burzynski's results to results of standard therapy that are deceptive in the extreme, given that small, unrandomized groups subject to selection bias are not comparable to larger clinical trials of standard-of-care treatments. Merola also can't resist using all sorts of scary graphics when discussing the chemotherapy drugs used as standard of care, referring to doxorubicin as the "red death" and taking care to point out that mitotane was derived from an insecticide. One thing's for sure, Eric Merola isn't subtle. He hits you over the head with his pro-Burzynski anti-pharma message over and over and over again. It must be that advertising background again.
The rest of the movie can be dispensed with rather quickly, as it's basically one big conspiracy theory, in which the NCI, the Texas Medical Board, the FDA, and, of course, big pharma (as represented by PhRMA all persecute poor, poor Dr. Burzynski because, if you believe the Eric Merola, (1) Burzynski has cured cancer and is a threat to big pharma and its chemotherapy monopoly; (2) Burzynski is a threat to the fees big pharma pays to the FDA to oversee clinical trials; (3) the NCI can't abide the competition. This whole section of the movie is introduced thusly by a narrator with an exceedingly creepy voice, complete with ominous-sounding background music playing:
The pharmaceutical industry is arguably the most profitable industry on our planet, with its profits being triple that of all of the Fortune 500 companies. Rising profits result in rising stock prices, the only way this industry can sustain this profitable momentum is by continuing to introduce new patented drugs. And since the pharmaceutical industry relies on the FDA as it's gatekeeper to introduce these new drugs, it's in their best interest to insure the FDA remains as compliant as possible. And since the FDA is also an office of the United States government, it's in the government's best interest to preserve one of it's most powerful industries. The former editor-in-chief of the New England Journal of Medicine, Dr. Marcia Angell, has been very outspoken with the idea that it's time to take the Food and Drug Administration back from the drug companies.
Repeat variations of this sort of passage over and over and over again interspersed with archival footage of various legal proceedings against Burzynski and occasional observations by Drs. Whitaker and Burzynski whining about how they are being persecuted, and you'll get an idea of what the last hour of the movie is like. It was painful to sit through because it was so blatant and, quite frankly, not very well produced--and there was that annoying robot-like narration describing the proceedings at every point. Particularly vile was the excessive use of the numerous testimonials of crying patients and parents telling various bodies of lawmakers or the Texas Medical Board that they'll die if Dr. Burzynski is convicted or has his license revoked. The paranoid conspiracy aura that surrounds Burzynski The Movie is palpable and becomes quite oppressive by the end of the movie. Pharma, the NCI, the FDA, the Texas Medical Board, and every medical authority are all against Burzynski, and he is the heroic doctor battling against all odds to bring his cure for cancer to all. Yes, it's just that nauseatingly blatant. At every point, antineoplastons are presented as nontoxic and effective, when they are neither. In fact, they can be quite toxic.
In fact, it should be emphasized that, despite all the claims that they are somehow "natural," antineoplastons are chemotherapy, as much as Drs. Whitaker and Burzynski try to portray them as "targeted." In fact, they're no longer even isolated from urine but synthesized and purified in Burzynski's laboratory, something that would normally be anathema to the "natural remedies" crowd. Indeed, early in the movie, there's a hilarious part where Burzynski, outraged at the criticism he received for using something extracted from urine, points out that hormone replacement therapy in the form of Premarin is isolated from horse urine. So obviously Burzynski's antineoplastons are just like Premarin, and doctors don't heap such contempt on that drug! The difference, of course, is that no one doubts that the estrogens and progesterone actually work; it's just that the question of an elevated risk of breast cancer has led to Premarin's having fallen out of favor.
One part of the movie that truly insults the intelligence of anyone with a modicum of knowledge about drug therapy occurs near the beginning of the movie. It's a part that, as a cancer surgeon who is interested in targeted therapies for breast cancer, I found particularly idiotic. First, there is a screen with this caption:
Antineoplastons target the specific genes that allow cancer to grow and flourish.
No evidence is presented to demonstrate this, of course, but there are nifty (and very science-y) images of DNA double helices flying towards the viewer, along with the chemical structures of various targeted drugs. A little later we see:
There are currently over 25 FDA-approved gene-targeted cancer drugs on the market today.
Many of them can only target single genes.
All of which is true but irrelevant if Burzynski is trying to sell antineoplastons as targeted therapy. Now here's the kicker:
Antineoplastons work on close to one hundred different genes.
You know what you call a drug that works on "close to 100 genes"? I don't know either, but you don't call it a "targeted" therapy unless all those genes are genes affected by the single target being inhibited; i.e., are downstream targets of the gene targeted by antineoplastons. In other words, Burzynski is trying to have it both ways. He's administering chemotherapy to patients on clinical trials and charging them for the privilege, but he's trying to represent his treatment as being somehow "targeted." That's why I say: Repeat after me. Antineoplastons are chemotherapy. Worse, they're chemotherapy that almost certainly doesn't work against cancer. At best, looking at the evidence, I conclude that they might have very minimal anticancer activity, and even that's doubtful.
The real problem with cancer research
Writer/producer Eric Merola uses Burzynski The Movie as a forum to pound on what he perceives as the shortcomings of the current regulatory system overseeing drugs. If anything, he's right that our drug regulatory system has severe shortcomings, but not for the reasons he thinks. Certainly it's not because it's trying to shut Burzynski down. Just the opposite. The huge flaw in our drug regulatory system is that, after over 30 years, it has failed to determine once and for all whether or not antineoplastons have any anticancer activity, despite allowing Dr. Burzynski to treat thousands of patients with them while driving the dialogue about whether antineoplastons work or not and portraying himself as a persecuted "brave maverick doctor." More disturbing from an ethics standpoint, somehow, Burzynski is still able to enroll patients on clinical trials, despite having failed to show compelling preclinical evidence of efficacy; worse, he charges them huge sums of money for the "privilege" of being on one of his clinical trials, something that is generally considered highly unethical, to the point of wondering how any Institutional Review Board could possibly approve such studies, particularly given that the FDA has warned Burzynski about how his IRB fails to protect human research subjects. Unfortunately, the Texas Medical Board failed to shut him down in the 1990s. It's apparently gearing up again to try to do so in early 2012. One can only hope that this time it's more successful.
In the end, Burzynski The Movie is perhaps the most appropriate vehicle for propagandizing Dr. Burzynski. Like Burzynski, it's unsubtle, low rent in the extreme, and lacking in anything resembling scientific evidence. Unfortunately, desperate cancer patients with terminal disease, even ones who would normally be more skeptical, can be blinded to the utter lack of evidence to support antineoplaston therapy because Dr. Burzynski gives them hope. Unfortunately, it's a false hope that has a high likelihood of draining their bank accounts to maintain Dr. Burzynski's empire of pseudoscience before they die.
Wow--a rerun of the very first Orac post I ever read.
It's sad that two of the four patients named have died: we all know about Billie Bainbridge, but Kelsey Hill, one of the cases used in the movie died, about two weeks after Orac wrote the piece in 2011. I guess Merola won't be using her story as a follow-up in the new commercial.
It also pisses me off that Eric Merola's own cousin Domenica, who died as a Burzynski patient, still appears to be alive and fundraising. Couldn't anyone be bothered to take down this webpage or update it in two years?
We've all questioned Merola's motivation in making the commercial for Stan, and we've wondered if a paper trail would trace the financing back to Burzynski.
What if Merola offered to make the movie as payment for his cousin's "treatment"? Do I now sound like a tinfoil conspiracy nut?
Just noticed something:
Domenica Prescott (Eric Merola's first cousin) died May 11, 2011. Nine days before that, she posted on the "Setting Them Free" page that her tumour was "diminishing" (let me guess, turning into a cyst). She had only been on the antineoplastons for four weeks when Stan gave her this good news.
Nine days later:
So this is at least the third case I can think of where Stan told patients their tumours were shrinking within a week or so of their deaths. Does he lie to everyone and just tell them what they want to hear? How can a doctor diagnose a tumour as "shrinking" and then have that patient die a week later?
I am fortunate to even have been made aware of Dr. Burzynski and Antineoplastons as another option via my cousin Eric Merola's work on Dr. Burzynski's story.
Right now, I fully qualify for FDA-approved clinical trials using Antineoplastons to treat my Glioblastoma brain cancer. All I need is the money to pay for it.
I have a sad now.
Do I dare push my luck with one more post before bedtime?
"Setting Them Free" appears to be nothing more than yet another fundraising vehicle for Burzynski patients, with a religious angle. On the current Patient Gallery" five people are asking for money for Stan.
Two have died (Nadyne and Anita); one went to Burzysnki and one did not.
The stories and medical histories are on each patient's profile. Nadyne went through the entire Robert O. Young Miracle pH scam first which failed. She didn't make it to Houston.
Anita did attend the clinic but ran out of money. She is convinced she developed cancer from stress of a family crisis and financial devastation. This is from her page:
My husband is a contract writer working most jobs that last only 3 months. As a contract worker, he receives no benefits. We have maxed out our credit cards to $30,000, and our modest home has a $200,000 mortgage, on which we pay $1300/month. We need to find $5,000/month to continue my treatment at the Burzynski Clinic. We cannot find a doctor in our home state that will even help us maintain the Burzynski protocol. This includes Mass General Yawkey Cancer Center, Dana-Farber Cancer Institute, and Beth-Israel Cancer Center. They are stuck in their age-old “standard of treatment,” (radiation and chemo) that they have used for many years. My HMO does not help with the expenses, since the Houston clinic is not in their network. We desperately need your help if I am going to live.
From Gaby's profile:
Unfortunately, in the Spring of 2010 I found a lump on my left breast that turned out to be invasive ductal carcinoma which had spread to the lymph nodes. This required major surgery to remove the tumors and lymph nodes affected. My doctors recommended traditional chemo and radiation but I chose to follow the holistic route. Sadly, four months later I found 3 more lumps which are the same type of invasive cancer that keeps returning.
Why do people think they know better than doctors?
She's now looking for $10,000 a month for Stan when following the doctor's recommendations might have prevented all this.
From a pathologist's perspective: Based on the report of the infant's adrenal tumor, it does sound like a carcinoma (noting the extensive necrosis, vascular invasion and soft tissue invasion), so I doubt it was a benign adenoma. Without seeing immunostains (as noted, the addendum that should mention them is missing) one could not confidently say the tumor is primary or a metastasis.
There is a sneering comment attached to the report concerning its disclaimer about tests not cleared by the FDA. This is a standard disclaimer that path labs (including ours) use to describe immunostains, which do not have to be specifically approved by the FDA, but which are demonstrated to work by published research. Merola or whoever put in this comment apparently did not bother to check this out, or felt they could score a cheap point over it. Regardless, pathology immunostains are a well-established diagnostic modality based on both research and clinical practice, which is not something one can say for Burzynski's antineoplastons.
This includes Mass General Yawkey Cancer Center, Dana-Farber Cancer Institute, and Beth-Israel Cancer Center.
Interestingly, just this year, those hospitals were ranked by U.S. News & World Reports' Best Hospitals Survey within the cancer specialty as #7, #5 and #48, respectively. Two hospitals in the top ten in the nation for treating cancer.
Sorry to keep on about it, but referring again to Jodi Fentons' medical records (PDF) on the movie website, I'm still intrigued by the frozen section that was done during Jodi Fenton's stereotactic biopsy. As I understand it, a frozen section is only done when a rapid histopathology result is required during surgery. The only reason the surgeon would require a result during surgery, while the patient is still on the table, is if he/she was going to do something different, depending on what the result was. I also understand that it is possible to do a stereotactic tumor excision, as well as a biopsy.
I know Orac has suggested that the biopsy itself was responsible for the reduction in size of Jodi's tumor, but I suspect that her tumor was biopsied, and when the frozen section result came back as "High grade glioma", the surgeon proceeded to remove as much of the tumor as he/she considered to be safe. Jodi's tumor was in her parietal lobe, well away from her brain stem, so it should have been possible to remove most of it safely. Nowhere in the medical records released does it state that her tumor was inoperable. This would explain why the volume of the tumor as measured by MRI reduced by 97% between 5/11/00 and 6/1/00 (before starting Burzynski's treatment, it is worth emphasizing), if the tumor was removed on 5/15/00. Does this make sense to any surgeons or histopathologists out there?
Another thing I have noticed, in the letter from an unnamed person at OncoImaging, is this:
Review of the brain FDG PET scan performed on 6/8/00 demonstrated a frontoparietal photopenic focus consistent with a lack of metabolic activity. This corresponds to the MRI finding of necrosis with edema, and the lack of FDG uptake is consistent with no residual neoplasm.
The part in bold is highlighted in yellow. This means that 2 days after starting neoplastons on 6/6/00 (or possibly before since the radiology report for the MRI referred to is absent so we don't know the date - perhaps it was the one done on 6/1/00), the tumor had completely disappeared, leaving nothing but dead tissue and inflammation. As Orac points out above, it normally takes weeks for chemotherapy to shrink a tumor, certainly not 2 days.
It certainly looks as if this is yet another case in which a tumor was successfully removed, and the patient interpreted her doctors' advice to follow up with adjuvant chemotherapy and radiotherapy which would improve her chances of survival as being her only chance of survival. Once again the patient took a gamble by not having the adjuvant treatments and the gamble paid off, but another completely ineffective treatmet got the credit. I very much doubt that Burzynski had anything to do with it, apart from relieving Jodi of large amounts of money, of course.
I think it is very likely that Jodi Fenton owes her life to Dr. Rich who, according to another document on the movie website (PDF), performed Jodi's surgery at Saint John's Health Center in Santa Monica.
May I propose a third option regarding what Burzynski is?: a twat.
Should I consider this Doctor's credentials as more credible than Orac's?
Dr. Nicholas Patronas, is currently the Senior Clinician, Chief. Section of Neuroradiology,, Radiology and Imaging Sciences, National Institutes of Health, NIH Clinical Center
Court Testimony Of Nicholas Petronas, MD
(Board-Certified Radiologist Professor of Radiology at Georgetown University, and Founder of the Neuroradiology section of the National Cancer Institute)
Discussing the effectiveness of antineoplaston treatment vs. chemotherapy and radiation treatment in brain cancer.
May 24, 1993
Administrative Hearing Docket .503-92-509
License No. D-9377
In The Matter Of The Complaint Against Stanislaw R. Burzynski, M.D.
Before The Texas State Board Of Medical Examiners
Before Earl A. Corbitt, Administrative Law Judge
Volume I of II
May 24, 1993
Q: Dr. Petronas, what is your profession?
A: I'm a radiologist, a medical doctor specializing in radiology.
Q: Would you tell us briefly your educational background?
A: Well, after the medical school we have a year internship, four years residency in radiology, and in addition I had an entire year of training in neuroradiology. So my subspecialty is neuroradiology. It is the evaluation of the regions of the central nervous system.
Q: And would you relate your work experience, please?
A: when I finished my training I was at the University of Chicago for seven years as a staff radiologist at the University Hospital. And then I moved to the National Institutes of Health where I worked from '81 to '85 as a staff radiologist at the clinical center, which is the hospital of the National Institutes of Health. Then I moved to Georgetown University where I became full professor of radiology. And the National Institutes of Health contracted Georgetown radiological services, and I was sent from Georgetown back to NIH to cover the section.of Neuroradiology.
Q: And so you work at the National Institutes of Health hospital; is that where you work?
A: yeah, at the hospital initially as a federal employee from '81 to '85, and then on contract from Georgetown University. So I am one of the 17 radiologists who provide radiological services to the National Institutes of Health.
Q: What is the function or purpose of the hospital of the National Institutes of Health?
A: As you know, there are a lot of research protocols that
are going on, and people who are admitted to this facility are being admitted to try experimental treatment. As they are admitted to the hospital, the hospital requires an X-ray Department and radiologists to man the department. And so we evaluate the various lesions that are being admitted under these approved protocols, and we assess the effectiveness of the treatment given there, using imaging modalities such as MRI or CT scans and regular radiology.
Q: And that would be for the various health departments or what's called institutes?
A: Exactly, the various institutes, yes.
Q: Like the National Cancer Institute, that's one of them?
A: That's the biggest of all, yeah.
Q: What-- Basically then, you do the, in layman's terms, you do all the imaging work and interpretation for the National Cancer Institute testing of drugs?
Q: Because-- and what happens is, they give the drugs to the people and you have to get-- they have to have a scan before to see what they had--
Q: --then when they go into treatment they have to get scans to see what, if any, effect--
A: To see whether they are effective or not, yes.
A: That's my job, to assess the effectiveness of the drugs that are given there and to provide the diagnosis at the initial stage, upon admission.
Q: Dr. Petronas, did there come a time when you became aware of Dr. Burzynski?
A: Yes, it was when Michael Hawkins from NCI asked me to join a group of other physicians and scientist and come to Houston on a site visit to Dr. Burzynski's Institute in order to assess the best case scenario that he had to present us of his patients who were treated with antineoplastons. So that was the first time when I was aware that there was an anticancer agent. And I was called as an expert in assessing the images to evaluate, together with the rest, the other five members of that team, to evaluate the effectiveness of his treatment.
Q: And did you have occasion to actually go down to Houston, Texas?
A: Yes, we spent about seven hours at the Burzynski Institute and we reviewed the material that was given to us.
Q: What material did you review?
A: Initially there was a presentation of the cases by Dr. Burzynski; each different case was studied seperately. We were given the history, the pathology, the previous treatment and the timing of these treatments, and we have someone who recorded these data.
Then the histological slides were presented to one of our neuropathologist, one neuropathologist who was also a guest consultant in the team. We reviewed the slides and confirmed the histological of the grade of the tumor that Dr. Burzynski was indicating in his presentation. Then there were assessments of the images, either CT scans or CAT scans, or MRI scans. They were serial studies in any given patient. So we were able to see how the tumor started and how it ended up under treatment.
Q: How many patients did you concern yourself with at that time?
A : we reviewed the material of seven cases. We did not have more time to review more. These were the--
Q: So that basically took up the whole day?
A : The whole day. yes; one hour per case.
Q: And what happened after you reviewed the cases?
A: Well, we took our notes and we discussed the findings, and there was a report that was issued indicating what we found.
Q: We have marked for identification Exhibit 27. Will you see if you can identify that for us?
A: Yeah, I have seen this. Yeah.
Q: And is this-- What exactly is this?
A: it was a letter to Dr. Burzynski from Dorothy Macfarlane, one of the people who was part of the team. And the memorandum shows or summarizes are findings for each individual patient. And this is exactly document that we came up with.
Q: What was the basic conclusion of the-- that you indicated?
A: The basic conclusion was that in five of the patients with brain rumors that were fairly large, the tumor resolved, disappeared.
Q: Was that just happenstance? I mean, was that just by some miracle of--
A: Well, since the treatment given was started after the previous conventional treatments which had failed previously, we took the position that this probably represents the result of this new treatment. And so there was only minimal residual tissue at the tumor bed, which looked like a sca, and had no fissures to support that there was a tumor in the majority of the cases. Two of seven patients did not do very well. One of them deceased. The tumor dissolved at least
microscopically; we could see it with the naked eye, but it recurred later, a year later. And the other, there was
very, very minimal decrease in the size of the tumor. But the tumor was very big, the last one, the seventh, last two cases did not survive, although there was definite improvement in one of the two last cases.
Q: I guess that would be called an objective response in that these patients--
A: exactly, because we were six people and we all looked at images and we saw the chronological order. We checked the names of the patients on the films, and the files were obtained at different institutions from the entire country, basically where the patients were located. And we had no reason to believe that these were not the results of the treatments.
Q: Doctor, based on what you have testified to before about your background and credentials, it's fair to say, isn't it, that you have seen a lot of brain cancer patients?
A: yes, in fact, we see a lot of these cases.
Q: And that's part of what you do at the hospital, is to evaluate treatments on brain cancer patients?
A: Well, different cancers, but since I am the neuroradiologist I see all brain rumors. And I see a large volume of then.
Q: Now, with regard to at least the five patients, I think
you testified that five of the patients had their rumors resolved, they all--
Q: --disappeared. Can you give us some kind of context of that? How often does that happen with any-- with no treatment, just by spontaneous remission, or by whatever it is that you--
A: I'm not aware that spontaneous remission occurs; I don't think it does. And the available treatment only rarely produce results like that. The only medication-- the only treatment, which I think is the last resort, is radiation therapy. Chemotherapy has very little to offer unless there is an experimental protocol somewhere. However, conventional chemotherapy is-- provides very little, nothing, basically. Radiation, there are some reports indicating that radiation treatment in children particularly could lead to resolution of the rumors, although I don't know whether it is a permanent one or temporary. So when this happens it is very rare. And I have seen only isolated here and there where that has happened with radiation .
Q: With one case here or there--
Q: --an isolated report, you are talking about on a case by
A: Yeah. Well, radiation should give these results, if it works at all, the first two months after completion of the treatment. In these cases, all the patients had already failed radiation because they were treated months, several months after radiation was
given and had failed.
Q: What happens with these patients? Lets say they failed radiation; what happens then to the patient with brain cancer?
A: Well, it depends on the grade of the tumor. If the tumor is low grade, astrocytoma, and we are talking about primary gliomas, if it is low grade, survival for years is possible. If it is an intermediate grade, the anaplastic, the mean survival is two years, and if it is the high grade glioma the mean survival is about 12 months. That's it; they die in 12 months, they disappear.
Q: Now-- So are you saying basically for someone that's failed radiation-- It sounds like you are saying that if someone has already failed radiation, at least, that there's not too much else--
A: nothing to offer, exactly.
Q: --and that these people are going to eventually die of their disease, barring any unforeseen event or cure?
Q: and there is nothing that any-- that you could do at NCI?
A: Nothing we can do, no; not at the present time.
Q: All right. What about these five patients that are all basically doing-- how come they lived?
A: Well, it's amazing, the fact that they are living and some of them are doing well. They are not-- they are not handicapped from the side effects of any treatment, and worse than the tumor itself. So these particular individuals not only survived, but they didn't have major side effects. So I think it is impressive and unbelievable.
Q: How many times have you ever seen this, in your experience, that someone comes with a drug like this, to have this kind of effect? How often does that happen?
A: I don't-- I have not seen it at any time with the medication that is given systematically. We have done-- we have an experimental protocol at the NIH where we inject a chemotherapeutic agent through the carotid artery, the artery that goes to the brain, and we have three survivals with this technique, by providing massive amounts of chemotherapeutic drugs to the brain that harbors the tumor. And we destroy the tumor, but we destroy a large part of the brain as well, and the patients became severely handicapped , and a life that's not worth living.
And so I have three cases with this particular experimental protocol which resulted in killing the tumor, but a large part of the healthy brain as well. So overall the protocol was abandoned and is not any more in effect because of the serious side effects that we witnessed.
Q: Now, let me ask your opinion or advice. Based on what you have seen from these patients-- I mean, I think the opinion actually, or the letter actually concludes that the site team concluded that there was antitumor effect from the antineoplastons. What would happen, let's say for some reason Dr. Burzynski's brain tumor patients can't get the medicine any more and have to go off treatment. What's going to happen to them, in your opinion?
A: I think these patients will die.
Q: One of the patients you reviewed was F.M.; is that correct? What happened in his case?
A: The tumor was very large and very involved the hypothalamus, a very sensitive part of the brain cannot be operated, and had both cystic components and fleshy components, mass like. And the lesion disappeared . This patient did not have previous treatment, if I recall, other than-- previous chemotherapy or radiation, and the tumor disappeared under our eyes. It was a low grade astrocytoma, wich is comparable with long survival. However, even those low grade astrocytomas, when we see them, they don't go away even though they may permit the person to live for many years. In this particular patients case the tumor disappeared, and there was a small, tiny remnant left, small percentage of the original size. And there has been several years since then and the patient is well, I'm told.
Q: So at least for the patient you would not recommend that
he go off the treatment, would you?