Science-Based Medicine ? Dr. Stanislaw Burzynski's cancer ...

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:

Dear Burzynski Movie Subscribers:

Major International Distribution Deal For
Burzynski: Cancer Is Serious Business, Part II:

We are pleased to announce that Burzynski: Cancer Is Serious Business, Part II has landed a major international distribution deal with one of America?s top distribution companies.

We can?t give out any specific details until everything is finalized, but promise to keep you informed. All we can say is, if you live in North America and own a television set, you will be likely able to see this new documentary by summer. However, the distribution deal stretches beyond just television.

Given this new development, we had to halt all pre-sales for the DVD to follow the protocols required of us by the distribution company. We are re-opening pre-sales now, with the new ship date being July 1, 2013 (instead of March 5, 2013).

The rest of the e-mail consisted of explanations of how those who had already preordered the movie for March 5 shipping would get a bonus if they kept their orders active and waited until July to receive their DVD.

On the surface, this would appear to be a horrible development, if Merola has indeed managed to secure some sort of international distribution deal. However, I?m not quite so sure that it is, as I?ll explain below. In fact, in retrospect an announcement of this sort should not have come as such a surprise to me for two reasons. The first reason is that, earlier this week, I had contemplated purchasing a copy of this movie so that I could know what it contained. However, not being thrilled with potentially revealing my name, credit card information, and home address to Eric Merola?s company, I thought that, if I were to order this movie, I?d do it through PayPal if that were an option and have it shipped to either my work address, which is public, or to a postal box. So I went to the Burzynski Movie website, only to find a message claiming that, due to high demand, orders were temporarily no longer being taken. That sounded odd to me, but oh, well?

Worst of all, there was also a notice that the first Burzynski movie will be shown twice on Thursday, March 7 on the Denver affiliate of Colorado PBS (discussed here). However, as I read this self-congratulatory bit of blather from Eric Merola, whose job it is to compose self-congratulatory blather for use in corporate infomercials, something seemed odd. I didn?t know what it was at the time, but it soon became apparent when someone sent me a link relevant to my post from two weeks ago about Burzynski?s cancer ?success? stories that very likely aren?t. What I discovered is that Hannah Bradley, one of the ?success stories? and a woman whose partner had made his own video about Burzynski and who will feature prominently in Eric Merola?s latest paean to the ?brave maverick doctor? Burzynski, had finally posted a new vlog:

When last I discussed Hannah Bradley?s story, I pointed out how cute I thought Hannah and her partner Pete were. Their love for each other radiates from the screen. However, I also felt obligated to point out why I thought that she was not the ?miracle cure? that she was being advertised as by Eric Merola. For a complete explanation, read my previous post. The CliffsNotes version for those who don?t want to read my previous lengthy post is that Hannah?s tumor, an astrocytoma (which is a form of glioma) did indeed appear to regress, but that regression can likely be explained by the surgery and radiation therapy that she had. The other part of the argument was that it is premature to represent Hannah as some sort of ?miracle cure,? given that the median survival for someone with her tumor is in the range of two to three years, and she?s only just reaching the two year mark. In other words, contrary to the story being spun about her by Merola and Burzynski, it is not that surprising that her tumor has what appears to be a radiographically near-complete remission (by ?radiographically? I mean what can be seen on imaging studies like MRIs) or that she is still alive. Her progress is still well within the expected behavior of the tumor that she has. If she were alive four or five years from now and tumor-free, that would be much more remarkable. Even then, however, it would not be evidence that the antineoplastons saved her because there are occasional complete remissions in this tumor type, and long term survivors, although uncommon, are not so uncommon that Hannah must be evidence that antineoplastons are so miraculously effective that they saved her when conventional medicine could not.

Finally, what most made me wonder about what was happening to Hannah was my simple observation that she and Pete have not posted images of any of her MRIs since late August. This is in marked contrast to each new MRI up to that point, which did show promising regression of the enhancing lesion and cystic area left over from her surgery. Also, she and Pete posted a vlog on November 1 that sounded as though it had bad news, but apparently took it down, as it?s not there anymore. As I said two weeks ago, I was worried. Real worried.

Now comes this latest vlog, and I?m more worried about Hannah than ever. Indeed, I almost fear to say what I feel obligated to say, because no matter how I do it, it?s likely to be spun, as Merola?s movie clearly has done to other skeptics with his ham-fisted shots of cancer patients crying about how skeptics are ?attacking? them, as an ?attack? on Hannah and Pete or as trying to rob them of hope. I also realize that there is a fine line between trying to use a case like Hannah Bradley?s as a means of educating the public about ineffective cancer ?cures? and coming off as attacking someone with a serious cancer. I try very hard not to cross that line, and I think I?ve been successful, for instance, here. However, if there?s one thing I?ve learned during all these years, it?s that if the person I?m discussing finds out about my post, that person always perceives it as an attack and lashes out. Similarly, Burzynski?s groupies realize that it is very effective to appeal to emotions and cast Burzynski?s critics as heartless villains so in the thrall of big pharma, ideology, or whatever that they will viciously rip into a patient whose life is threatened with a deadly cancer. Personally, I?d be very happy for Hannah and Pete if she were to survive to outlive me, whether it were due to conventional therapy, Burzynski?s therapy, or a combination of the two. I hate seeing people die of cancer, which is one big reason I became a surgical oncologist in the first place. And if it were Burzynski?s antineoplastons that did the trick, I?d be both happy at the discovery and furious at Burzynski for jerking people around for so many decades instead of doing the work it takes to prove the value of his treatment.

So why am I even more worried than ever about Hannah? It started right from the first shot of her latest vlog. Look at her face. It?s subtle, but, I think real: an increased asymmetry in which her lower lip on the left part of her face is droopier than I had ever noticed before. I first noticed this in her Christmas vlog but it appears worse now, particularly in comparison to her in the 40 minute Hannah?s Anecdote, which included lots of shots of her from December 2011 and January 2012. In those shots, she appeared to have had a bit of this going on then, but it was quite subtle. It?s not so subtle anymore in her latest vlog and suggests that the tumor might be growing and impinging on nerves going to her face. She also struggles for words in a way that I don?t recall ever having seen her do before. At one point, she has a hard time thinking of the word ?risk? and has to be prompted by Pete. All of this makes me wonder if she?s developed an anomic aphasia. I could be wrong about Hannah?s facial asymmetry; I?m not a neurologist. I?m also less sure about the aphasia; it could well be that she simply had a bit of difficulty finding a word not worse than any other person. In fact, I?d like to be wrong about this (and any neurologists and/or neurosurgeons out there reading tell me if I?m wrong about this?I?ll tack on an addendum if you convince me). But I don?t think I am, at least not about the facial asymmetry.

Next, Hannah admits that she has a ?really cystic area in my head? but insists that there?s no enhancing tumor and doesn?t really say if what is there is increasing in size or stable. Given her affect and the expression on her face when she discusses these issues, I truly fear that it must be growing. There?s also the issue of the marked change in how she and Pete discuss her scans. In Hannah?s Anecdote and their vlog of July 27, 2012, Hannah and Pete exult (and understandably so!) that Hannah has had a ?complete response.? Now, ?complete response? means just that: a complete response to therapy. No tumor detectable by MRI. That implies that anything seen on imaging now must have arisen between the scan of last August and now. Presumably, it arose between August and November, the time when she and Pete first noted that the news was ?not the best of news.?

I hate to say it, but I?ve seen this story before. I?ve even encountered it before myself. Burzynski has a tendency to tell patients with brain tumors that the formation of ?cystic areas? is a good thing that indicates his treatment is working. The most recent example I remember of this was Amelia Saunders, whose father reported on Facebook in November that Burzynski told them this:

Tonight is the update we?d always hoped we?d be able to write, but it has taken an enormous amount of faith and hard work to get this far ? and there were many times we didn?t think this would happen.

Amelia?s tumour is dying, from the inside. We?ll be getting another opinion from here on this, but the scans do back this up. There are cysts forming inside the tumour where cancer cells would have been before.

For the moment, we seem to be winning our little battle.

We are trying our hardest not to get too excited yet. These cysts are forming inside the tumour but it isn?t shrinking ? however this proves the treatment is working. Remember that Amelia has received no other treatment.

Amelia Saunders, as you recall, was the unfortunate little girl who developed an inoperable diffuse intrinsic pontine glioma and whose family managed to raise ?200,000 in just 12 weeks to send her to the Burzynski Clinic for antineoplaston therapy. In September, several stories in the UK represented her as a ?miracle cure? because she was able to attend her first day of school. Unfortunately, as I knew at the time, the ?cysts? that Burzynski was holding out as evidence that the antineoplastons were working were nothing of the sort. I knew that they almost certainly represented areas of ischemia (low blood flow) leading to tissue death as the tumor outgrew its blood supply. This is a phenomenon commonly seen in advanced malignancy. I knew this because tumor angiogenesis has been one of my areas of research interest, and I?m a co-author on one of the first papers to show that combining antiangiogenic therapy with radiation showed promise in animal models. Basically, tumor cells are constrained in their growth to the diffusion of oxygen and nutrients in aqueous solution unless they can induce the ingrowth of blood vessels, a process called tumor angiogenesis. That?s why tumors can frequently can outgrow their blood supply by growing faster than they can induce blood vessels to grow, and when that happens, areas in the center of the tumor will die and liquify. Surgeons are very familiar with this phenomenon, as are radiologists. Tumors frequently, as they progress, consist of a relatively thin rim of viable, growing cells surrounding a central area of necrotic tissue.

Not long after Burzynski?s whitewashing of Amelia?s November scan, Amelia started to deteriorate clinically. By late December, it was clear that she was dying. Sadly, Amelia finally passed away on January 6. Hers was a truly heartbreaking story, not the least of which because of the way that Stanislaw Burzynski appears to have strung the family along. I fear that he is doing the same with Pete and Hannah, who don?t deserve that any more than Amelia and her family did. One notes that in Pete and Hannah?s vlog of September 7, 2012, Eric Merola points out that Amelia Saunders was going to feature prominently in Burzynski II. This was shortly before stories about her going to school for the first time popped up all over the UK press, giving Burzynski some of the best press he?s ever had.

All of this brings us full circle to the sudden unexpected delay in release of Burzynski II: This Time It?s Peer-reviewed or Burzynski II: Electric Boogaloo (as I like to call the second Burzynski movie). Learning about Hannah?s latest scan right around the same time that I learned about the delay in release of Burzynski II made it difficult to avoid speculating that the two were somehow linked. Yes, it could well be a case of confusing correlation with causation and leaping to unwarranted conclusions. If that turns out to be the case, I will certainly admit I made a mistake. However, does it strike anyone else as odd that it is announced that the release of Merola?s movie is delayed three days before it was originally scheduled to be released and on the very same day we learn that one of its ?stars? who was going to be presented as a ?miracle cure,? as slam dunk evidence, along with Laura Hymas, that Burzynski cures incurable brain tumors, is no longer cancer-free? True, Hannah and Pete didn?t actually say that explicitly, but the inescapable implication is there. After all, when they thought that Hannah had had a complete response, they weren?t at all shy about saying so, while now they hem and haw. Again, this is one area where I?d be not just happy to be wrong, but downright ecstatic. Unfortunately, I fear I am not.

It might be that the reason for the delay in releasing Burzynski II is exactly as Merola has represented it. But one wonders why it would take four months and why the sudden last minute ?distribution deal.? Maybe it?s not so odd if Merola needs time to re-edit the movie in light of recent developments, which include questions about Hannah?s condition, the audit of the Burzynski Clinic and Burzynski Research Institute by the FDA, which has shut its antineoplaston operation down at least temporarily, and one possible development that I know about but can?t really discuss publicly yet.It just wouldn?t do to release the movie now and have large parts of it be refuted by events occurring soon after its release, such as the FDA shutting down the Burzynski Research Institute for good or one of the movie?s two ?success stories? turning out not to be as represented. After all, Merola acknowledged publicly that, unlike the case with the first Burzynski movie, this time around the subject is ?fast moving? and events are moving rapidly. Maybe they?re moving more rapidly than even he thought.

Merola tries to paint Burzynski as the iconoclast, the ?brave maverick doctor? who is curing cancer while big pharma, the ?cancer industry,? and the government through the FDA try to shut him down to protect their hegemony. From my perspective, the real story needs to be emphasized again and again. There are many patients whose families have gone to huge lengths to raise sums as high as several hundred thousand dollars to pay for treatment at the Burzynski Clinic under the auspices of Dr. Burzynski?s ?clinical trials? that never seem to produce much in the way of useful data despite his having opened and closed dozens of them since he was ordered in the 1990s by the Texas Medical Board and the FDA not to use antineoplaston therapy except in the context of a clinical trial. Despite that, Dr. Burzynski has set up quite the cottage industry in which patients pay hundreds of thousands of dollars for the ?privilege? of being treated on a ?clinical trial? with antineoplaston therapy, even though it is not FDA-approved, has never been convincingly shown to work, and has significant toxicities despite Burzynski?s claims that his treatment is so nontoxic. So we have many patients harnessing the generosity of kind-hearted strangers to pay for woo. It?s a depressing litany of people, mostly children, teenagers, and young adults like Billie Bainbridge, Kelli Richmond, Olivia Bianco, and Shana Pulkinen. And, most recently, there have been Rachael Mackey and Amelia Saunders. There are so many more.

And now there Hannah Bradley, who, I hope, really is cured but unfortunately have ample reason to fear is not. All of these stories are used by Burzynski apologists and promoters to feed into the cult of personality that is Stanislaw Burzynski. Desperate, in many cases dying, people are used to sell what I consider to be the myth of Burzynski. Again, this is a delicate topic to take on, but I see little choice but to analyze these stories. As long as they are being used by people like Eric Merola to sell Dr. Burzynski?s ?legend,? they have to be discussed. After all, film projects like Merola?s entice these patients to come from all over the world to spend precious weeks of their remaining time in a foreign country far away from home and pay hundreds of thousands of dollars that they don?t need to spend for a treatment that almost certainly cannot save them and for which there is no good published evidence. Remember, Hannah and Pete have even stated that Merola?s first movie about Burzynski was a huge reason they became convinced that the Burzynski Clinic was Hannah?s only hope. Stating publicly on this blog that it isn?t is not easy, because I take care of cancer patients. Even though I have thus far been fortunate enough not to have cancer myself, that doesn?t mean family members haven?t; indeed, my mother-in-law died nearly four years ago of a particularly nasty form of breast cancer. Even as a cancer doctor, I still wanted to believe that there was hope, even though all my knowledge told me that there wasn?t. At that point, even I might have been tempted by Burzynski. My only hope is that putting this sort of analysis of the patient cases used to sell Burzynski?s antineoplastons out there can give patients who are thinking of going to the Burzynski Clinic a science-based assessment of Burzynski?s work to allow them to make a much more informed choice, in marked contrast to the marketing that is all they will find in the work of Eric Merola and others who function in essence as unpaid advertisers to promote the glory that is Burzynski. These propagandists spin a story of one man who can cure cancers that no one else can, and that story is very compelling to desperate people with advanced cancer. Sadly, when it comes to Eric Merola, evidence doesn?t matter, and it is the patients who are potentially harmed.

Source: http://www.sciencebasedmedicine.org/index.php/burzynski-success-stories-update-movie-sequel/

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