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

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

The movie, Burzynski: Cancer Is A Serious Business, Part 2, was released to online sources on Saturday and will be released on DVD on July 1. As much as I detest Eric Merola and don’t want him to profit from his deceptions, I also wanted to see what the finished product actually looked like. So I swallowed hard, paid, and watched. It was probably the worst $15 I ever spent, but at least it’s tax-deductible for my not-so-secret other blog, from which I do earn a small amount of money for my writing. Of course, from my perspective, actually seeing the movie is almost anticlimactic given that we’ve had detailed reports from screenings of the movie by skeptics (excuse me, Skeptics) who attended, replete with conspiracy mongering, repeating claims to the movie to an echo chamber, and even Fabio Lanzoni. However, there are things one can’t adequately evaluate using second hand reports. Moreover, it just so happens that tonight the BBC will be airing an episode of its long-running news series Panorama about Burzynski. The episode is entitled Cancer: Hope for Sale? Although I fear the producers falling into the trap of false balance, I’ve heard enough from my connections to suspect that Burzynski won’t be happy at all about the story. After all, his minions have been pre-emptively attacking Panorama since Burzynski patients have let it be known that they had been interviewed for the report. Now, if we “Skeptics” were the all-powerful, overarching, nefarious force that Burzynski’s acolytes paint us as, one might think that we had planned it this way, to have the BBC Panorama episode come out the Monday after the release of Eric Merola’s movie. I’ll let Eric Merola puzzle over that one. No doubt he’ll build another one of his—shall we say?—imaginative conspiracy theories over this.

So what about the movie itself? First, let me point out that, after having seen the movie (which I will henceforth call “Burzynski II”, to distinguish it from the first Burzynski movie, which I will call “Burzynski I”), there’s nothing I would change in my original discussion of it. Burzynski II really is just like Burzynski I, only more so. I refer you to the link for my discussion of many of the problems with the movie. Here I will concentrate mainly on issues that I haven’t discussed before, because actually seeing Burzynski II was a revelation. (Heh, I put that sentence there on purpose Eric Merola; quote mine it if you dare!) First, as a movie, Burzynski II is at least as bad as Burzynski I. Eric Merola is a crappy, crappy filmmaker. The narration is done by the same creepy-sounding narrator such that it sounds like a low bit rate MP3 (say, 32 kbps); certain medical terms are mispronounced; there are lots of errors; and Merola demonstrates the same tendency to switch back and forth between camera angles in which the subjects of his interviews are looking at the camera to angles where they are not. The effect, I’m guessing, was intended to be edgy. What it ended up being (to me, at least) was irritating as hell. The music and cheesy graphics are also much the same as they were in Burzynski I.

The other thing that I wasn’t prepared for was just how unrelenting Burzynski II was in its propaganda. Burzynski I was one-sided to the point of ridiculousness, but Burzynski II takes that ridiculousness to the next level, much as each sequel to the original Transformers or The Fast and the Furious movies tends to be bigger, louder, and dumber than its predecessor. This is not a good thing. In Burzynski II, I mentioned that the messages are:

  1. Stanislaw Burzynski is a genius who invented “personalized gene targeted cancer therapy,” and is now being emulated by centers like M.D. Anderson, which are furiously trying to catch up.
  2. Burzynski is a Brave Maverick Doctor who is curing patients that conventional science can’t cure, and it’s not his fault when he can’t.
  3. Burzynski is a real scientist with tons of data supporting antineoplaston therapy who is being unjustly hounded by the FDA, the NCI, and big pharma to prevent him from bringing his cancer cure to market.
  4. The Japanese are on the verge of publishing definitive clinical trial evidence that antineoplastons work!
  5. Skeptics are evil meanies who cackle evilly as they terrorize cancer patients online and delight in crushing their hope.

Unfortunately, in Burzynski II the messages are even less subtle (if that were possible) than in Burzynski I. Whereas Burzynski I hit you over the head with its messages repeatedly if they were a series of 2x4s, in Burzynski II the 2x4s have bricks attached to their ends.

Burzynski II does have a slightly different structure than Burzynski I, however, although overall it’s very similar in many ways. Burzynski I spent the first 30 minutes or so discussing patient anecdotes to “prove antineoplastons work,” and then spent most of its last hour or so lambasting the FDA, the Texas Medical Board, and big pharma. Burzynski II, on the other hand, although it begins similarly with some text declaring just how awesome Burzynski is and how evil the FDA, the Texas Medical Board, and big pharma are, followed by a montage of news and TV segments extolling Burzynski and/or attacking his critics, is a bit more free-form, interspersing patient anecdotes with attacks on big pharma, plus a truly bizarre segment attacking “The Skeptics” near the end. I’ve already dealt with at least four of these anecdotes before, those of Laura Hymas (whose anecdote is the main one), Hannah Bradley (who gets surprisingly little screen time), Tori Moreno, and Amelia Saunders (whose anecdote is perhaps the most heart-wrenching if you know what happened—more on that later); so I won’t dwell on these anecdotes again here except for aspects that I haven’t discussed before that seeing the actual finished movie bears light on.

An ethical conundrum dealt with correctly

One of the things I wondered about last time was a segment in the movie in which Laura and her fiancé Ben Hymas, having decided to go to the Burzynski Clinic, met with Ms. Hymas’ NHS oncologist to try to find out if the NHS would continue to cover her MRI scans, blood tests, and other medical “necessities” once she returned home to the U.K. Ms. Hymas, as you might recall, is a young woman who developed a brain tumor, underwent conventional therapy that only had limited success in slowing the tumor, and ultimately ended up deciding to go to the Burzynski Clinic. It is revealed in the movie that Ben Hymas had decided to record the conversation with the oncologist, and Eric Merola decided to include the recording in his movie. The results are not exactly what Merola intended. Merola clearly intended it to be damning of the NHS; in reality what I saw was a clinician desperately trying to do the right thing and dissuade Laura from a course of action that he considered to have almost no likelihood of helping. For instance, when Ms. Hymas says that the oncologist (who is not named) would not treat her if she went to Burzynski, here’s what he said:

Oh, no, no, no, no, no. Let’s make it very clear. Dr. Burzynski is a person who provides “private care,” in a non-conventional way—that we do not quite understand, or would condone.

Later, he says:

It’s not just his antineoplaston approach, which is controversial to say the least. I’ve had patients there who got cocktails of medications that could have a rationale to work in brain tumor patients but have never been tried and tested in this excessive combination.

The oncologist tries to point out that Burzynski’s clinical trials are not supported by the NHS or his hospital and explains that Ms. Hymas can’t expect the NHS to pick up the tab for tests required by Burzynski for a clinical trial not sanctioned by the NHS. He goes on to explain how the trial is not ethically approved at any NHS hospital and that because he’s not convinced that this is a useful therapy he can’t treat her according to Burzynski’s protocol and that he can’t provide care to her as long as she is under Burzynski’s care.

And here’s where the FDA’s failure has put doctors like this one in a bad position. Ms. Hymas’ mother keeps harping on how if the FDA approved these trials they must be legitimate and can’t be unethical. You know and I know that that’s not necessarily true (and, in fact, I’ve recently learned a lot about how and why these trials were originally approved by the FDA despite the lack of adequate preclinical evidence, but that’s a topic for another post). Another doctor at the NHS also apparently did agree to such an arrangement, which also put this poor oncologist on the spot in talking with the Hymas. Still, in the end, this oncologist said point blank that he does not feel it would be right of him to take instructions or even advice from Burzynski for what is and is not required, although he did appear to indicate a receptiveness to ordering Laura’s scans.

I keep thinking of what I would do if I were in that oncologist’s shoes. I don’t know. I do find it despicable that Merola would use an apparently secret recording of a private conversation and put it in a public movie. This should serve as a warning to all cancer doctors: If you have a Burzynski patient, expect to be taped and conduct yourself as though your words could show up in the next Merola infomercial.

The patients again and an ethical conundrum dealt with incorrectly

To the old familiar anecdotes are added new ones. I’m going to start with the one that is both new to me and most horrifying to me as a cancer surgeon, even more so than the cases I’ve discussed before such as Amelia Saunders or Hannah Bradley. I’m referring to Chris Onuekwusi, a man who was diagnosed with stage I colon cancer. Yes, you read that right. I’m referring to a patient with a stage I colon cancer. You should know that stage I colorectal cancer is very, very treatable. Resecting the involved segment of the colon or rectum containing the cancer has a high probability of curing it. Assuming it really is stage I, chemotherapy might not even be needed. (We don’t know for sure that Onuekwusi’s cancer really was stage I, because often surgeons don’t know the full stage of colorectal cancer until after surgery.) Instead of undergoing straightforward surgery that we know to have a high probability of success (which, I’ll also point out, can be done these days through minimally invasive laparoscopic techniques), Onuekwusi balked, as described in more detail than in the movie in this article on the Burzynski Patient Group website. He had even gone for a second opinion at one of the leading cancer centers in the world, the University of Texas M.D. Anderson Cancer Center, where the surgeon told him the same thing. He needed surgery first.

So what did Burzynski recommend instead of surgery? He recommended a cocktail of three drugs given off-label: Zolinza, Xeloda, and Avastin. Zolinza is vorinostat, a histone deacetylase inhibitor; Xeloda is capecitabine, which is a prodrug for 5-fluorouracil (5-FU), a pyrimidine analog that inhibits the enzyme thymidylate synthetase and thereby inhibits DNA synthesis to toxic effect in rapidly dividing cells; and Avastin is bevacizumab, a humanized monoclonal antibody directed against vascular endothelial growth factor-A (VEGF-A). As I described in a previous post about Burzynski’s “personalized, gene-targeted cancer therapy,” apparently Burzynski sent Onuekwusi’s tumor to Caris for testing. Caris generated a report, as it always does, and Burzynski came up with a witches’ brew of new expensive targeted agents, all said to be “off-label.” Well, not exactly. One of these drugs is just an old chemotherapy drug in a new form. Xeloda is, in essence, 5-FU, a chemotherapeutic drug that has been used to treat colorectal cancer, both as adjuvant chemotherapy and first-line therapy for metastatic disease, for over 40 years. There’s nothing really “targeted” about the drug except that it inhibits an enzyme, the way that many drugs do and have been known to do for decades. The advantage of Xeloda is that it can be administered orally, which is a good thing. Similarly, Avastin, although relatively new, is also commonly used for colorectal cancer, albeit usually for metastatic disease and not as adjuvant chemotherapy. That leaves Zolinza, which is an HDAC inhibitor used to treat cutaneous T cell lymphoma. One wonders if Burzynski included a second HDAC inhibitor, his second favorite drug after antineoplastons, sodium phenylbutyrate.

So why was I so horrified by this anecdote compared to others? The reason is simple. Onuekwusi appears to have had a relatively easily curable cancer with standard surgery, and that surgery is usually not particularly morbid, given that the scans shown in the movie indicated that it was a right colon lesion, as opposed to a sigmoid or rectal lesion. It is, in my opinion, medical malpractice to treat such a patient first with chemotherapy (and yes, what Onuekwusi received was chemotherapy, as Xeloda is basically an oral form of one of the workhorses of chemotherapeutic drugs, 5-FU). We know that chemotherapy usually doesn’t do a lot of good as primary therapy of solid tumors like colorectal cancers, although as adjuvant therapy it is quite effective at decreasing the risk of recurrence after surgery. In contrast, we know that surgery is highly effective for stage I colorectal cancer. We even know that if this really were stage I colorectal cancer, Onuekwusi wouldn’t even have even needed chemotherapy! Surgery alone is the treatment of choice. So, by Merola’s own description, what Burzynski did was to administer a toxic form of treatment that was probably not needed (chemotherapy) using drugs that were not approved for that indication, and apparently didn’t insist that the patient needed surgery. Now, it’s possible that the combination of drugs did eliminate the tumor. It’s also possible that the tumor was very small and completely removed with colonoscopic biopsy, leaving an inflammatory reaction behind to be imaged on the PET-CT images shown in the movie, a reaction that subsided over three months. Either way, Onuekwusi (and Burzynski) might have gotten lucky. But they both took an enormous gamble that could well have cost Onuekwusi his life. In my opinion, Burzynski deserves to have his medical license taken away on the basis of how he treated Chris Onuekwusi alone, not even considering all the other dubious things he’s done.

The rest of the “new” cases (i.e., cases I hadn’t been familiar with) followed a similar pattern to cases I’ve discussed before, wherein it’s impossible to tell whether the patient’s good fortune is due to Burzynski’s treatment or not. That includes the patients with brainstem gliomas. We are told repeatedly by the narrator that spontaneous remission of a brainstem glioma has never been documented in the medical literature, despite an exhaustive search. All I can say is that Merola and Burzynski must not have searched very hard, because I quickly found a few, for instance, of pontine glioma (and two more) and a brainstem cavernoma. Remember Tori Moreno? She is a teenager who was diagnosed with a brainstem glioma as a neonate who features prominently in this film as a Burzynski success story. Despite what Tori’s father and Eric Merola claim, it’s quite possible that she underwent a spontaneous remission. True, such remissions are rare, but it’s not correct to say that they never happen. Truly, Merola’s “exhaustive” research skills need some upgrading. It took me two minutes to find those articles. No, I’m not saying that that’s definitely what happened; I’m merely pointing out that it could have happened, which is why clinical trials are so important.

Among the “new” patients is also a woman named Patricia Clarkson with multiple myeloma, who is filmed with her husband in front of large windows with the sun shining in. Yes, they are mostly backlit; one would think that Merola could have found a better, less distracting room to interview them in. Be that as it may, the segment is introduced with in essence a rant about the FDA requiring that patient fail standard therapy before they can have antineoplastons. That is, of course, a standard requirement for new cancer drugs because on an ethical basis doctors can’t administer experimental therapy whose efficacy is unknown if there are treatments whose efficacy is known. Another common design for a clinical trial is to compare standard of care treatment against standard of care treatment plus the experimental therapy.

This segment is introduced by a black screen of white text that says:

Even if the FDA’s prerequisite if fulfilled, the FDA holds full dictatorial rights to refuse patients’ access to antineoplastons if they choose.

Merola says that as if it were a bad thing. It’s a rule designed to protect patients. Merola makes it sound as though this is an arbitrary rule designed solely to keep patients from getting antineoplastons. Mr. Clarkson, of course, rails against the FDA for making it so difficult for his wife to be treated with antineoplastons. What is not shown is that Burzynski did treat her with sodium phenylbutyrate, the orphan drug that is a prodrug for one antineoplaston. As is the case with nearly every Burzynski testimonial, it’s impossible to tell whether Burzynski’s treatment has done any good due to confounding factors. In Clarkson’s case, multiple myeloma tends to be a disease that has a highly variable clinical course and can take years before it can kill, sometimes several years. In other words, its survival curve tends to have a long tail. Mrs. Clarkson was only diagnosed in 2011 It’s also a drug that almost always seems to be included with Burzynski’s “personalized gene-targeted cancer therapy regimens,” almost no matter what.

Seeing is believing?

I can’t do a review of this movie without revisiting stories we’ve seen before. Even though I’ve extensively covered the cases of Laura Hymas and Amelia Saunders before, to me seeing is knowing just how intellectually dishonest Eric Merola is. For instance, seeing the Saunders family, rather than just hearing about them from second-hand reports, was truly heart wrenching. They are such a caring family who were so desperate to do anything for their daughter. Worse, however, is the way that Merola makes it sound as though the reason that Amelia Saunders ultimately did not survive her tumor is because her parents decided to take her off the antineoplaston therapy. I’ve discussed this issue before. Briefly, in November 2012 it was noted that Amelia’s tumor had started to develop cystic regions. Burzynski told the Saunders that this was evidence that the tumor was dying. As I pointed out at the time, this was almost certainly nothing more than the tumor outgrowing its blood supply and developing necrosis in the center, not evidence of an antitumor effect. Sadly, two weeks later, pediatric oncologists at the Great Ormond Street Hospital told the Saunders the same thing and that they thought Amelia was in the end stage of her disease. It was at that point that the Saunders made the completely reasonable decision to take Amelia off the antineoplastons.

This is how Merola describes it:

Two months after this interview, Amelia’s brain tumor began to swell and fill with fluid. There was confusion and disagreement between their local radiologists and the radiologists in Houston about why this was happening—so her parents decided to discontinue antineoplaston therapy. Amelia passed away with her parents at her side on January 6, 2013.

Merola then opines:

Brainstem glioma is as rare as it is deadly. Approximately 500 children a year in the United States and 40 a year in England are diagnosed with it. An exhaustive search spanning 27 years of all available medical literature worldwide reveals the absence of any patient ever being cured or living five years after diagnosis.

As I said before, Merola’s research skills leave much to be desired. True, five year survival is very uncommon, but not so uncommon that it can’t be studied. Similarly, as I pointed out before, it’s not true that spontaneous remission of brainstem tumors in children “never happens.” It’s rare, but it does happen.

Seeing The Skeptics

I’ve already extensively discussed Merola’s attacks on skeptics before, in particular his misinformation and paranoid conspiracy mongering. He goes out of his way to portray us as either incredibly misguided (“they mean good but do evil!”), hopelessly in the pay of big pharma, or so evil that we, as I put it before, cackle with glee as we condemn cancer patients to certain death by taking their antineoplastons away. It’s so heavy handed that even Leni Reifenstahl would turn away in embarrassment if she were alive today and subjected to a viewing. (Some of that would also be due to her recognition of Eric Merola as a talentless hack when it comes to being a filmmaker.)

Particularly seemingly damning are a series of Tweets flashed on the screen saying things like the Hope for Laura fund (the fund set up by Laura Hymas to pay for her treatment at the Burzynski Clinic) “appears to be just a money laundry for a lying quack fraud” and “when Laura dies #Burzynski will just move on to his next mark if she doesn’t run out of money first.” I think I know whose Tweets these were, and all I can say to that person is this: Zip it. In fact, if I’m correct about whose Tweets these are I think I have already done so on Twitter when I’ve seen this person getting too close to attacking cancer patients. Still, as utterly insensitive and “dickish” as those Tweets were, they do not represent the majority of skeptics, but rather a few jerks. However, we as skeptics need to remember that a few jerks perceived (or painted) as attacking cancer patients can do immeasurable damage to the cause of science-based medicine. So if you’re one of those skeptics making comments like that, knock it off. If I see you doing it, I will call you out publicly.

In contrast, I find it very hard to believe that any but the most deluded hard-core Burzynski believers will find the segment in which Bob Blaskiewicz, creator of The Other Burzynski Patient Group and the force behind the idea of promoting donations to a real cancer charity and challenging Burzynski to match it, anything but completely risible. His voice is electronically altered to make it sound ominous and evil; his face is blurred out, and the Virtual Skeptics podcast in which he discussed Burzynski is represented as a “Skeptics’ teleconference,” in which it is implied that Merola somehow obtained a secret discussion. It’s all very silly. I’d say it’s almost Monty Pythonesque, except that Monty Python were brilliant and produced such effects on purpose. Merola is a hack and is only funny by accident because he has no filters that tell him when he’s going way over the top.

So is Merola’s treatment of yours truly. There’s a hilarious picture of my SBM page with my picture partially blurred out, onto which Burzynski places marks for emphasis that I’ve been funded by the DoD (past tense, Eric, not the present tense that you used), the NIH, ASCO, and other organizations (as if getting peer-reviewed research funding were a bad thing). Then there’s the bit about my former funding, a small grant that’s been expired nearly a year now from Bayer Healthcare. Then, of course, there’s my not-so-super-secret other blog, which—gasp!—accepts advertisements from pharmaceutical companies. I knew about all of that before, but actually seeing it onscreen was rather bizarre. I can only wonder what it would have been like to be sitting at a screening of this movie and seeing it.

Then, there was the kicker.

Eric Merola and Laura Hymas’ fiancé Ben Hymas called me a liar. Regarding this particular blog post, they claim that I intentionally linked to an older blog post describing Ms. Hymas’ MRI results and ignored a more recent MRI. Their claim is patently untrue. Note the date of the post in question: November 30, 2011 at 1 AM. (Yes, the post was written on November 29 and set to go live at 1 AM the next day.) Now note when Ms. Hymas underwent that other MRI scan: November 29, 2011. Finally, note when Ms. Hymas posted the results of that scan? November 30, 2011, after the blog post in question went live. I suppose the accusation is that I am not psychic and able to have anticipated that there would be an MRI scan. Moreover, I agree with a commenter who showed up on January 8 and pointed out:

He never claimed they were the November results. He was analyzing the October vs. September results. In fact, the October vs. September results are more significant (in terms of size) than the November vs. October results. Laura is misrepresenting the report.

Here is a breakdown of the sizes of the tumor (in cm or cm2:

Sept = 2.0×2.5 = 5.00

Oct = 1.8×2.1 = 3.78

Nov = 1.7×1.9 = 3.23

Now, the percent reduction in size:

Sept->Oct = (5.00-3.78)/5.00 = 24.4%

Oct->Nov = (3.78-3.23)/3.78 = 14.6%

Sept->Nov = (5.00-3.23)/5.00 = 35.4%

In other words, the 36% reduction was over 12 weeks, not 6 as claimed, and about 2/3rds of that reduction occurred between the two scans ORAC analyzed. Interesting that Laura never posted the MRI from the November scan for comparison, nor any of the earlier scans from when she was undergoing conventional treatment. Also interesting that she claims she was told that her radiotherapy couldn’t have any effect because she only completed 7 of 44 doses of chemotherapy.

My post from November 30, 2011 was correct as written at the time it was written. Ben Hymas is quite mistaken in saying about me, “He’s lying to them.” Moreover, if I had screwed up, I would have admitted it. Indeed, part of the reason I looked into this so closely was because I wondered if somehow Merola had actually found a mistake I had made. You know the saying about the proverbial blind squirrel occasionally managing to find a nut? It’s possible, albeit unlikely, and in fact there was no mistake. Well, that’s not entirely true. I did misspell Ms. Hymas’ name; it’s a mistake I went back and corrected when I discovered it. (You’ll have to forgive me, as it was the first time I had read about the Hymas case.) In any case, the only reason I didn’t post an update was because the commenters had done such a good job addressing the criticisms that showed up a couple of days later. Whether you think that I should have posted an update or not, one can’t help but note that nowhere does Eric Merola mention that I wrote a much more recent analysis of Ms. Hymas’ clinical situation in February 2013 that incorporates all updates. It also pains me that Mr. Hymas would take Merola’s explanation at face value. I feel nothing but sympathy for relatives and friends of cancer patients, and I want Ms. Hymas to do well, but it hurts to hear Ben Hymas repeat Eric Merola’s demonstrably false accusation against me.

In case either Hymas sees this post, let me briefly repeat my most recent assessment of Ms. Hymas’ history as described online, my basic conclusion about Ms. Hymas’ case in February was this:

Laura Hymas is different in that she provides somewhat more suggestive evidence for a possible antitumor effect from antineoplastons, given the longer period of time since she finished her radiation therapy and since her still being in complete remission five and a half months after her first scan showing no residual tumor. However, her case is by no means the slam-dunk evidence that Burzynski supporters claim it to be (or, for that matter, that Merola touts it as in his upcoming movie), given that it has been less than six months since confirmation of a complete response. Moreover, given that HDAC inhibitors do seem to have some efficacy against glioblastoma, it is not unreasonable to expect that antineoplastons might actually have had activity in Laura’s case. Making claims, as Burzynski does, however, that his antineoplaston therapy is more efficacious than conventional therapy is unwarranted based on a single patient. Conventional therapy can produce durable remissions and complete responses, too, and, although they are still rare, they are becoming more common. That’s why legitimate randomized clinical trials are needed to determine if PB/antineoplastons have antitumor effects in humans; which tumors are sensitive; if there are any biomarkers of sensitivity; and to separate the signal from the noise. Anecdotes like those of Hannah Bradley and Laura Hymas can be suggestive, but in and of themselves prove nothing.

There is nothing in Merola’s deceptive movie to change my assessment of what happened in the case of Laura Hymas’ brain tumor or my opinion of Eric Merola. If anything, having seen Burzynski II, my opinion of Merola has plummeted even further, something I hadn’t thought possible.

Evidence, evidence, wherefore art thou, evidence?

Another section of the movie that I was highly interested in, having discussed it before twice, was Dr. Hideaki Tsuda’s antineoplaston research in Japan, which Keir Liddle characterized as underwhelming, and rightly so. This segment came near the end of the movie, right after the segment on The Skeptics and obviously meant as a retort to Burzynski critics.

What I learned about the trial was this. The trial was of a design like what I mentioned above, chemotherapy alone versus chemotherapy plus antineoplastons. Specifically, the trial tested 5-FU infused directly into the hepatic artery for liver metastases versus 5-FU plus antineoplaston A10 and AS2.1. A10 was administered intravenously for one week, and AS2.1 was given in the form of capsules for at least one year. Dr. Tsuda takes pains to insist that he got no advice or assistance from Burzynski, but that protocol is very specific. Why antineoplastons A10 and A2.1? Why A10 for only one week? Why A2.1 for a year? I also note that this is a rather old technique. Back in the 1990s, intra-arterial chemotherapy for liver metastases was all the rage, but these days, because of more aggressive resection of liver metastases and newer, more effective chemotherapy regimens for metastatic colorectal cancer, intra-arterial chemotherapy is seldom used anymore, much less intra-arterial 5-FU. That’s not even considering the technical complexity of placing the intra-arterial infusion pump and the potential complications from having a catheter in the hepatic artery. Dr. Tsuda is behind the times. Indeed, one notes that the CT scans shown from Dr. Tsuda’s group purporting to demonstrate responses to his combined regimen all date back to 1999, which makes me wonder just when this trial was done and, if it was done so long ago, why it hasn’t been published already.

As for the trial, were 65 patients, 33 in the control group and 32 in the antineoplaston group. Dr. Tsuda reported in the movie that the median survival for the control group was 36 months (which is actually rather long for liver metastases treated with intra-arterial 5-FU alone) and that the median survival for the 5-FU plus antineoplaston group was 70 months. Again, all I can do is to emphasize the usual things. This study is not published in peer-reviewed literature, and it was, in my estimation, highly irresponsible of Dr. Tsuda to promote it in a propaganda film before he actually published the results. We have no way of knowing whether the two groups were well-matched or if there were other methodological problems with the study. Let’s just put it this way. It’s way premature of Dr. Tsuda to proclaim that it’s “obviously not anecdotal any more.” Publish first, and let the scientific community be the judge of that.

There was also another part that makes me wonder whether this study will ever be published. Right after Dr. Tsuda proclaims antineoplastons not to be anecdotal any more, we’re treated to this quote from him:

We can’t go any further with these clinical trials allowing antineoplastons to gain market approval exclusively for the Japanese people—due to the Unites States FDA and the power they have over the world market.

The FDA would retaliate against any Japanese pharmaceutical company who would try to get antineoplastons approved in Japan by no longer approving their other drugs for the market in the USA.

It’s the perfect conspiracy theory. Dr. Tsuda claims to have data from a randomized clinical trial that’s good enough to use to gain approval for antineoplastons from Japan’s equivalent of the FDA, but he says he can’t because the FDA would retaliate against Japanese pharmaceutical companies. As I said, one wonders whether Dr. Tsuda will ever publish the results of his trial.

That leaves us with John James, who is listed as a research scientist with Targacept Pharmaceuticals, ranting about how cancer is profitable, how pharmaceutical companies have no incentive to find cures for cancers, instead preferring chronically administered drugs, and telling the sheeple (OK, he doesn’t actually use that word, but the meaning is clear) to “wake up.” What’s not pointed out is that Dr. James no longer works for Targacept and instead has started working for Healing Seekers, a group that does expeditions to remote areas of the world looking for “natural” cures. In fact, he appears to have left Targacept in October 2012, which makes me wonder whether if his participation in this movie had anything to do with it, as the timing fits. Or perhaps he was just a victim of the wave of layoffs that hit in October in the wake of the failure of Targacept’s two ADHD drugs in recent clinical trials. After a similar round of layoffs earlier in 2012, perhaps James saw the writing on the wall.

No, none of it is particularly convincing if you know anything about cancer research. I could change my mind if Dr. Tsuda actually published his results and it turns out that his trial was very well designed, but from seeing him describe them in a propaganda movie like this? Not so much.

In the end, if Burzynski had the evidence, he would have very likely published it by now. Through other skeptics who attended a screening of Burzynski II in the San Francisco area, I’ve learned that Ric Schiff, whom we’ve met before both here and elsewhere and who is now, according to reports I’ve been getting, really peeved that I questioned his claim that he is an “expert” in detecting medical fraud when as a cop he views himself as a “fraud expert,” is claiming that all the phase II studies recently wrapped up and are being prepared for publication. I have my doubts about that, but let’s assume it’s true for the moment. If that’s the case, then I submit that Merola should have waited until after some of those complete phase II have been published in the peer-reviewed literature to release his movie. Then his trumpeting of Burzynski’s “triumph” over the FDA, the Texas Medical Board, big pharma, and The Skeptics might have been somewhat more convincing. Data talks. BS walks. And there’s no doubt that Burzynski II is pure BS.

Now, all I have to do for now is to wait until I have access to the episode of Panorama airing tonight in the U.K.



Posted by David Gorski

Dr. Gorski's full information can be found here, along with information for patients. David H. Gorski, MD, PhD, FACS is a surgical oncologist at the Barbara Ann Karmanos Cancer Institute specializing in breast cancer surgery, where he also serves as the American College of Surgeons Committee on Cancer Liaison Physician as well as an Associate Professor of Surgery and member of the faculty of the Graduate Program in Cancer Biology at Wayne State University. If you are a potential patient and found this page through a Google search, please check out Dr. Gorski's biographical information, disclaimers regarding his writings, and notice to patients here.