Last week, I reviewed a long-expected (and, to some extent, long-dreaded) documentary by Eric Merola, a filmmaker whose talent is inversely proportional to his yen for conspiracy, pseudoscience, and quackery. Through a quirk of fate that couldn’t have worked out better if I had planned it myself, a long-expected investigation of the Burzynski Clinic by the BBC aired on its venerable news program Panorama last Monday. It was entitled, appropriately enough, Cancer: Hope for Sale? Ever since learning that the BBC was working on this back in January or February, skeptics have been looking forward to it with a mixture of anticipation and dread, anticipation because we expected that the Panorama crew would “get it” (in the interests of full disclosure, I will mention that I was interviewed over the phone by a Panorama producer and exchanged e-mails to answer questions and suggestions), but a bit of dread because we feared the bane of all news reporting on issues of science and medicine: false balance.
So now that the report was finally aired, how was it? You can either watch it on iPlayer (if you’re in the UK) or on YouTube (if you’re not, assuming it’s still there):
Patients versus false balance, with regulatory issues missing
Although it’s better than the vast majority of reports on Burzynski that I’ve seen, I’m afraid it still ended up being a mixed bag. I’ll start with my general impression and then discuss some specifics that particularly stood out to me. Fortunately, there were parts of the report that hit home, and hit home hard. Unfortunately, every time I thought that Panorama was going in for the kill, the reporter (Richard Bilton) all too often seemed to back off. Perhaps it was the editing. From my interactions with a producer and reports I got from other skeptics who had similarly been contacted by the BBC, the team working on the report seemed to “get it,” which is why I can’t help but wonder if something got watered down in the final edit. Or perhaps it was the story structure imposed on this report, which was simultaneously a “he said, she said” portrait of a patient who believes in Burzynski and thinks he saved her, two Burzynski patients who died but whose families still express little or no regret over having decided to make the trip to Houston, and one patient who thinks Burzynski ripped him off. Interspersed with these stories was an overarching “where’s Waldo?” meta-story of Bilton trying to score an interview with the elusive subject of his report (whom he, predictably, gets to interview near the end of the report), all peppered with brief interviews with experts whose comments are generally critical but often softened with caveats that turn some of the criticisms into mush.
From my perspective, what is simultaneously the greatest strength and greatest weakness of this report is its relentless focus on patients. Specifically, the stories of four patients are covered: Hannah Bradley, Luna Petagine, Amelia Saunders, and Wayne Merritt. The first three patients were U.K. patients who travelled to Houston to be treated by Burzynski; Merritt lives in Georgia. This focus is a strength, because it provides an emotional hook upon which viewers can hang their attention, and, of course, the reason Stanislaw Burzynski’s activities are so harmful. However, this relentless focus is simultaneously a near-fatal weakness in that the obsessive focus on the patients seems to prevent the report from delving into a lot of issues that are also very important in any discussion of Stanislaw Burzynski. For instance, there was little or no mention of the recent FDA investigation of the Burzynski Clinic and the partial clinical hold placed on antineoplaston usage, zero mention of how Burzynski recently managed to beat an effort by the Texas Medical Board to strip him of his medical license by throwing his employed doctors under the bus, and only the most superficial treatment of how in general it is considered unethical to demand payment from patients to participate in clinical trials. Nor is there any mention of how the Burzynski Clinic waged a campaign of harassment against bloggers who criticized Burzynski back in 2011. Indeed, one of the victims of that harassment, Rhys Morgan, was interviewed by the Panorama crew, but he was informed that his interview was cut from the final version because it didn’t fit the narrative. There is even at least one howler in which Bilton intones that “nobody knows exactly what’s in his treatment,” when in fact it is fairly well known what antineoplastons are and has been for at least 25 years. All you have to do is to read Saul Green’s reports on Quackwatch and in The Cancer Letter from the 1990s.
Unfortunately, the story repeatedly falls prey to that weakness of first following this patient or patient’s family, then following that patient or patient’s family. Admittedly, the overall impression of Burzynski left behind is not favorable, but we don’t get a good overview of what he is doing and why it is so wrong, just what he did with respect to these four patients plus a little background. Of the patients, Luna Petagine’s and Amelia Saunders’ stories are the most heart-wrenching. Indeed, Luna’s story was featured last year on a BBC documentary about the Great Ormond Street Hospital, and some excerpts from this documentary are shown to introduce Luna and her story. One of them reminded me very much of the conversation with her NHS oncologist that Laura Hymas recorded and allowed Eric Merola to include in his propaganda piece, except that in video it is so much more intense. In this scene, the oncologist tries to point out to Ms. Petagine that he doesn’t know what Burzynski is doing or how to take care of her daughter when she returns. I really felt for this oncologist, too. However, this segment on Luna also highlights another irritating aspect of this report, which hit me over the head in the very next scene, when Ms. Petagine in essence lambastes the NHS oncologists because they couldn’t save her daughter’s life, saying, “The NHS told me Luna’s going to die. This man is telling me that he thinks he can cure her.”
The report includes interviews with experts like Professor Richard Grundy of Nottingham Children’s Hospital. Grundy points out that Burzynski has not published the complete results of any of his phase II clinical trials. Right after him is Professor Peter Johnson of Cancer Research U.K. discussing the importance of reproduction of results. Actually, this is one of the stronger segments in that it points out the importance of publishing scientific results in the medical literature and how that is the key to convincing other scientists of the validity of your work. That was very clear and concise. It’s also, unfortunately, simultaneously one of the weaker segments in that it ends up sounding as though there’s just no evidence and we don’t know about antineoplastons. In other words, it sounds as though they very well could work, if only the clinical trials were done. It’s a theme that is repeated throughout the report but that ignores the astounding level of sheer deception that goes on at the Burzynski Clinic, the allegations of overfilling, and how Burzynski has abused the clinical trial process to keep treating patients with antineoplastons without actually having to do the science that any other doctor would be required to do to validate a new treatment. True, not all the doctors who question Burzynski’s treatment are that wishy-washy. Dr. Elloise Garside, a research scientist, echoes a lot of the questions I have, such as why Burzynski never explains which genes are targeted by antineoplastons, what the preclinical evidence supporting their efficacy are, or what the scientific rationale is to expect that they might have antitumor activity. (Yes, we’re talking prior plausibility, baby!) This explanation was provided right after Bilton and she sat through a screening of the first Burzynski movie, which was a fairly nice touch.
None of this is to say that there weren’t aspects of the report that were very powerful and spot on. I just wish there were more of them or that more time had been allotted for them. For instance, there was the discussion of how Burzynski attracts new patients, which led to a trip to a screening of Eric Merola’s first foray into medical propaganda; i.e., his first movie in 2010 extolling the glory that to him is Stanislaw Burzynski. There’s even a sarcastic little rejoinder about how Burzynski takes his message to the movies rather than publishing in the peer-reviewed scientific literature. Particularly amusing is how Panorama includes a scene from the first Burzynski movie in which Burzynski lambastes the panel evaluating him, saying how he will get his antineoplastons approved all over the world and bring them to justice, while promising the hundreds of patients who died because of them will come back to haunt them until their deaths.
Yeah, Stan’s as warm and fuzzy as ever.
Panorama also confirms what skeptics have suspected for a long time now, namely that the Burzynski movie has been very, very effective in attracting patients to the Burzynski Clinic. During an interview with Hannah Bradley, whom we’ve met before. There’s no real evidence that Burzynski’s treatment is responsible for Bradley’s good fortune in having lived more than two years with her cancer thus far, but she attributes her survival to him. Unfortunately, she is also incorrect when she says that there’s no evidence that antineoplastons work or that they don’t work. The preponderance of evidence supports the contention that they don’t work, but there is uncertainty, which Burzynski exploits to the max. In any case, as lovely a young woman as I think Ms. Bradley is, the whole segment is painful to watch, as she asks ignorant questions like, “What says radiotherapy works?” When the reporter points out that the peer-reviewed literature says it works, Ms. Bradley says, “But not for everyone,” which is technically true but ignores that there isn’t any evidence comparable to that for radiotherapy that antineoplastons work for anyone. As much as I like Hannah Bradley and her boyfriend Pete Cohen and hope Hannah continues to do well, I can’t let such statements go unchallenged.
Ironically, I can’t help but note that Pete Cohen also showed up on the radio to be interviewed by Victoria Derbyshire on BBC Radio 5 Live (at around the 1:44 mark). I can’t help but mention it here, because Mr. Cohen gives away several interesting tidbits. For instance, it’s very obvious that the Burzynski Clinic is in communication with him, because Mr. Cohen claims that Burzynski is preparing manuscripts for publication and that he has even submitted several to “top journals.” He even claims that Burzynski has asked that they be independently reviewed. In doing so, Cohen echoes the claims in some of the Q&A’s after screenings of Eric Merola’s most recent movie that Burzynski’s papers have been rejected without being sent out for peer review. It’s also not exactly clear what Cohen means by that. Studies submitted to journals won’t be published without going out for peer-review. Maybe he’s referring to some of the papers we’ve heard about from Mr. Cohen and others that were editorially rejected and not even sent out for peer review because the editor either didn’t think them appropriate or didn’t want to waste the reviewers’ time. Mr. Cohen also repeatedly says how he has approached experts in brain cancer and begged them to come out to the Burzynski Clinic to “see for themselves.” Seemingly, he can’t understand that it is not necessary for a scientist or doctor to meet Dr. Burzynski or visit his clinic. It means nothing. Nada. Zero. Zip. In science, all that matters is what you publish, and Burzynski hasn’t published anything other than case reports, tiny case series, and unconvincing studies, mostly (at least over the last decade or so) in crappy journals not even indexed on PubMed.
Without a doubt, the most effective part of the story is the segment in which Dr. Jeanine Graf of the Texas Children’s Hospital is introduced. Dr. Graf is the director of the pediatric intensive care unit there and has taken care of lots of Burzynski patients, as her hospital is “just down the road” from the Burzynski Clinic and these unfortunate children are brought to her hospital when they decompensate. Indeed, coupled with this segment is an interlude where Luna Petagine’s mother complains that the staff there know and recognize Burzynski patients (and, she notes, hate the Burzynski Clinic). Particularly damning is how Ms. Petagine said that the Texas Children’s Hospital Staff “were always cleaning up Burzynski’s messes.” Luna was brought to the Texas Children’s Hospital during her time in Houston, and the staff there recognized right away that she was a Burzynski patient because they had seen so many similar patients suffering the same complications before. It was also clear how much contempt the staff there had for the Burzynski Clinic. If there’s one thing Panorama did right in this report, it’s showing how seeing so many already-dying children show up in their ICU because of hypernatremia due to antineoplaston therapy will do that. Perhaps the most devastating part of this segment was seeing Dr. Graf stating, point blank, that she’s never seen a Burzynski patient survive. True, she does point out that patients don’t come to her until they are in extremis, but the fact remains that she’s never seen any of them live.
It’s a sad and devastating segment.
Unfortunately, during the most critical part of the story of all, in which Bilton finally “finds Waldo” and is granted an audience with Stanislaw Burzynski, Bilton came across (to me, at least) as unprepared. Fortunately for Bilton, Burzynski was, as is so often the case, his own worst enemy, smirking and behaving in his usual arrogant, dismissive manner to any sort of challenge. (You can see a sample of it here, towards the end of the promo.) If Burzynski were a bit less full of himself and the greatness that he thinks he possesses, he could have wiped the floor with Bilton. As it is, the interview was pretty much a draw. Burzynski claims that antineoplastons can cure cancer, but not for everyone. Burzynski smirks when asked how many patients he’s treated and how many have survived, dodging the question by saying that the FDA won’t let him until he’s published his results. Bilton tells him that’s not true; the FDA has told him that Burzynski can tell him as long as he doesn’t promote antineoplastons. Burzynski asks Bilton why he doesn’t have a letter from the FDA. Burzynski dismisses Bilton with retorts like:
You look like a bright man but you’re asking me the same question again and again. Are you catching Alzheimer’s disease or what?
As I said, Burzynski’s arrogance, dismissiveness, and condescension make him his own worst enemy. Bilton was very, very lucky.
Burzynski also pulls out the old trope that, the FDA wouldn’t have let him use antineoplastons for 20 years in clinical trials if they weren’t safe and potentially effective, that the FDA wouldn’t let him “sell hope without evidence.” (Those of us following Burzynski for a while know, unfortunately, that that isn’t necessarily true.) Burzynski then promises that antineoplastons will be approved “soon” (they almost certainly won’t), after which he goes on to repeat the same refrain he’s been repeating for the last decade or so about how he’s on the verge of publishing all the results that will convince everyone. “Just you wait,” Burzynski is saying, in effect, “I’ll show them. I’ll show them all!”
One notes that we’re still waiting.
Ultimately, the Burzynski Clinic did release some results, stating that 776 patients with brain tumors were treated in trials and that 15.5% have survived five years. Of course, this is an utterly meaningless factoid (if factual it even is), because we don’t know what kinds of tumors, what grades, how they were treated beforehand, or any other confounding factors. Burzynski needs to publish, but I highly doubt that he will, at least not in a form that is informative to real oncologists.
Overall, the producers of Panorama did a decent, but flawed job of taking on Burzynski. Part of the problem might have been that a half hour is just too short. It’s really difficult to explain 36 years of history and the ins and outs of Burzynski’s battles with the law and patients in just a half hour; so apparently Panorama didn’t even try. That left it asking the question at the beginning of how Burzynski has gotten away with this for so long but not really even trying to give an answer at the end. It also might be that expectations were too high in the skeptic community, myself included. While I can understand the decision to concentrate on patients as the center of the story, the problem with that decision is that it’s a well-trod path that crowds out too many other important issues that ended up getting short (or, far more commonly, no) shrift in this Panorama episode. In the end, Panorama played it safe, and its report ended up being fairly unoriginal and guaranteed not to be the definitive look at Burzynski. It’s a very good thing that Panorama decided to shine a light into the recesses of the Burzynski Clinic, but at best it’s a first, flawed step. As good as much of this episode is, some of it is not, and I fear that an opportunity has been lost.
Stanislaw Burzynski against his own SEC filings
A lot of things happened last week with respect to Stanislaw Burzynski. In addition to Eric Merola releasing his documentary and Panorama finally airing its report, it was pointed out to me by a number of readers that there was new information to be had in Burzynski’s most recent SEC filings for the Burzynski Research Institute. The reason this is important is that it provides us with information against which we can compare Burzynski’s claims in both Merola’s movie and the Panorama report. Part of what inspired me to look into this was Josephine Jones openly asking whether Burzynski lied to the BBC. Regular followers of the Burzynski saga will remember that in January the FDA showed up at Burzynski’s operations to investigate. As Merola likes to harp on, FDA investigators stayed until March. Currently we are awaiting the FDA’s decision, which is usually posted to the FDA website in the form of a formal letter. In any case, the reason this is relevant is because the FDA put a clinical hold on antineoplastons and barred the enrollment of any new patients in any of Burzynski’s protocols. Moreover, in response to a warning letter from the FDA last fall about promoting an unapproved drug, in January the Burzynski Clinic removed all references to antineoplaston therapy on its website, which is rather like Major League Baseball removing all references to, well, baseball on its website.
To recap, we know that last year a child suffered a severe adverse reaction to antineoplaston therapy, which led to the FDA putting a clinical hold on antineoplastons for children. Then, in January apparently, the clinical hold was placed on antineoplastons for adults as well, although apparently patients already receiving them could continue to do so. Actually, I wondered about that when I saw a rather fascinating part of the Panorama report, namely a tour of Burzynski’s manufacturing facility, which, we are told, can crank out 300 L of antineoplaston solution per day.
Which brings us to the Burzynski Research Institute SEC report, something that Josephine Jones touches on as well. Throughout Eric Merola’s infomercial for Burzynski and the BBC Panorama report, we are told by Burzynski, his acolytes, and his shills that antineoplastons will be approved by the FDA “soon,” that he’s been doing the trials to gain FDA approval over the last 15 or 20 years, and, oh, by the way, not to worry. We have been promised repeatedly that all those phase II clinical trials that Burzynski registered will similarly be published “soon.” Even Pete Cohen, Hannah Bradley’s partner, showed up on BBC Radio 5 promising that Burzynski is furiously submitting manuscripts for publication. But what’s really happening?
Josephine Jones points us to this recent SEC report for the Burzynski Research Institute for the fiscal year ending February 28, suggesting that we read the section entitled Partial Clinical Hold on Phase II and Phase III Clinical Trials. So I did. Now I’m not a businessman, and I don’t understand anything but the very basics of business. A lot of these SEC reports might as well be Greek to me, but I do know cancer science. I also know what Burzynski and his acolytes have been saying, one of which is that the phase III trial will probably never be done because it’s “too expensive.” Yet in the report, we read:
On February 23, 2010, the Company entered into an agreement with Cycle Solutions, Inc., dba ResearchPoint (“Research Point”) to initiate and manage a pivotal Phase III clinical trial of combination Antineoplastons A10 and AS2-1 plus radiation therapy (RT) in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma. Research Point has secured interest and commitments from a number of sites selected. Upon completion of this assessment, a randomized, international Phase III study will commence. The study’s objective is to compare overall survival of children with newly-diagnosed, diffuse, intrinsic brainstem glioma (DBSG) who receive combination Antineoplastons A10 and AS2-1 plus RT versus RT alone.
Three years should be plenty of time to line up clinical sites for a phase III trial. Of course, given that after three years the clinical trial hasn’t been opened, more than likely no reputable institution wants to partner with the Burzynski Research Institute, and ResearchPoint collected its checks. Then came the partial clinical hold, which affected this phase III trial as well as all the phase II trials, and, fortunately for patients, Burzynski’s antineoplaston operation is shut down. Revealed in the SEC report, of all places, is why.
It’s a long excerpt, but I think it’s important. There’s a lot of legalese and FDA bureau-speak, but the meaning should be fairly clear to a layperson:
In a letter dated June 25, 2012, the Company informed the FDA of a serious adverse event which may have been related to the administration of Antineoplastons. On July 30, 2012, the FDA placed a partial clinical hold for enrollment of new pediatric patients under single patient protocols or in any of the active Phase II or Phase III studies under IND 43,742. The FDA imposed this partial clinical hold because, according to the FDA, insufficient information had been submitted by the Company to allow the FDA to determine whether the potential patient benefit justifies the potential risks of treatment use, and that the potential risks are not unreasonable in the context of the disease or condition to be treated. The FDA cited 21 C.F.R. § 312.42(b)(2)(i), 21 C.F.R. § 312.42(b)(1(iv), and 21 C.F.R. § 312.42(b)(3)(i), as grounds for imposition of a clinical hold; and 21 C.F.R. § 312.305(a)(2), a criteria for expanded access use. The FDA advised the Company that until it resolved the matter to FDA’s satisfaction, the Company could not enroll new pediatric patients in any protocol under such IND. The Company later notified the FDA in a September 24, 2012 letter that it was closing pediatric protocol BT-10 (under IND 43,742) for enrollment effective September 25, 2012, and that it would also terminate the protocol once all active patients had completed the study.
In other words, no more antineoplastons for children, not now, and, hopefully, not ever. Burzynski can continue to treat children on his protocols who had already started treatment, but that’s it. This is very good news. After all, the Burzynski Research Institute is shutting down the pediatric protocol.
This ultimately led to the partial clinical hold being extended to adults:
In a teleconference on January 9, 2013 between the FDA and the Company, followed by a letter of the same date, the FDA notified the Company that the agency was placing IND [investigational new drug application] 43,742 on partial clinical hold, due to a lack of a complete response to the issues raised by the FDA and what the FDA deemed a misleading, erroneous, and incomplete investigator brochure. The FDA cited 21 C.F.R. § 312.42(b)(2)(i) and 21 C.F.R. § 312.42(b)(1)(iii), as grounds for imposition of a clinical hold. The FDA further advised the Company that until it resolved the matter to the FDA’s satisfaction, that the Company could not enroll new adult or pediatric patients in any protocol under such IND. The FDA also placed protocols B-52 and B-54 on clinical hold due to what the FDA deemed to be an unreasonable and significant risk of illness or injury to human subjects. The FDA cited 21 C.F.R. § 312.42(b)(2)(i) and 21 C.F.R.§ 312.42(B)(1)(i), as grounds for imposition of a clinical hold. The FDA advised the Company that until it resolved the matter to FDA’s satisfaction, the Company could not legally conduct the identified clinical studies under such IND.
In a letter dated April 9, 2013, the Company responded to the issues raised by the FDA in its January 9, 2013 letter to the Company. In a letter dated May 9, 2013 from the FDA, the FDA advised the Company that the Company’s April 9, 2013 letter was not a complete response to all the issues listed in the FDA’s letter dated January 9, 2013, and the FDA also identified the issues that were not fully addressed by the Company’s response. The FDA further advised the Company that until it satisfactorily addressed all the issues in the FDA’s letter dated January 9, 2013, that the FDA could not complete its review, and the clinical hold could not be removed.
So basically, the FDA extended its clinical hold; the Burzynski Research Institute answered the FDA’s charges; and the FDA was not satisfied. Until the Burzynski Research Institute can adequately address those concerns, there will be no new patients enrolled. If I were a betting man, I’d bet that no new patients ever will be enrolled because maybe, just maybe, the FDA is finally cracking down on Burzynski for real. At least, that’s what I hope. I’m all too aware that it looked just as bad for Burzynski in the 1990s, which was the last time the FDA made a serious run at the Burzynski Research Institute, and Burzynski managed to slither away to come back bigger and stronger than ever. Even so, Burzynski’s own SEC filings suggest that all the bold talk of imminent approval of antineoplastons by the FDA and publication of the papers that will prove to the world that antineoplastons work are pipe dreams, stories to keep the marks on board and hoping. Indeed, even the report seems to concede that antineoplastons will likely never be approved, even going so far as to point out that “the Company cannot predict if and/or when it will submit an NDA [New Drug Application] to the FDA, nor can the Company estimate the number or type of additional trials the FDA may require.” Burzynski also warns:
Notwithstanding the response results of the trials that have reached a Milestone, management believes it is likely that the FDA may require additional clinical trials based upon such protocols to be conducted by an institution not affiliated with the Company or Dr. Burzynski before advising that an NDA filing is warranted. In addition, the FDA has indicated it will not accept the efficacy data, but will accept toxicity data generated by the Phase II study according to Protocol CAN-1 because the trial was partially retrospective. At this time, the Company cannot predict if and/or when it will submit an NDA to the FDA, nor can the Company estimate the number or type of additional trials the FDA may require. Further, there can be no assurance that an NDA for antineoplastons, as a treatment for cancer, will ever be approved by the FDA.
No assurance can be given that any new IND for clinical tests on humans will be approved by the FDA for human clinical trials on cancer or other diseases, that the results of such human clinical trials will prove that antineoplastons are safe or effective in the treatment of cancer or other diseases, or that the FDA would approve the sale of antineoplastons in the United States.
That hardly sounds as though antineoplastons will be approved “soon.” After all, the Burzynski Research Institute’s own SEC filing states that an NDA hasn’t even been submitted and that it can’t be predicted when an NDA will be filed. Presumably if Burzynski were truly on the verge of getting antineoplastons approved by the FDA he would have said so in his SEC filing. That’s why his SEC filings are so revealing. Burzynski can distort and exaggerate when speaking to the public, but lying on an SEC filing could carry potentially serious consequences.
Another interesting tidbit in the SEC filing is Burzynski’s report of the results of several of his clinical trials. They aren’t really “results’ per se, in that the information presented really isn’t provided in a form that really allows other investigators to evaluate it and potentially replicate it. Basically it’s a big table listing Burzynski Research Institute clinical trials and response rates reported. One thing that I noticed right away is that in most trials, the number of evaluable patients is smaller, sometimes much smaller, than the number of patients accrued. This is a huge red flag. For instance, in trial BT-20, there were 40 patients accrued by only 22 were evaluable. This sort of dropout rate is a huge red flag. We don’t know the reasons for this dropout rate. It could certainly skew the results, but even that’s impossible to tell from just a table of response rates and no further information. Of course, I realize that this is an SEC filing, not a scientific paper in the peer-reviewed literature, but if Burzynski has all this data to produce this table it boggles the mind that, given at least a decade and a half since these trials began, he hasn’t been able to publish any meaningful data thus far. That he hasn’t been able to do so is also a big red flag.
One can’t help but wonder why BBC Panorama didn’t look at this information. It could easily have fit into the narrative. Imagine a more prepared reporter, faced with the confident and sarcastic bloviation from Burzynski that antineoplastons will be approved “soon,” pulling out Burzynski’s own SEC filings and telling him that that’s not what he said in those filings. I can only imagine two reasons Bilton didn’t do that: The report wasn’t out when the interview occurred (which is possible, given the mentions of a date in early May) or lack of preparation. If it were the former situation, a more prepared reporter could have hammered Burzynski on how he could possibly say so confidently that antineoplastons were going to be approved “soon” with partial clinical holds by the FDA on children since the fall of 2012 and on adults since January 2013. These are hardly the sorts of issues that suggest imminent approval, contrary to Burzynski’s statements, which now must be viewed, in my opinion, as outright lies. Indeed, even if the SEC filing wasn’t published yet at the time this interview took place, imagine a voiceover tacked on after Burzynski’s statement pointing out that his own SEC filings contradicted his assertions. Moreover, bringing up these issues would arguably have fit into the narrative perfectly to point out that Burzynski is still promoting antineoplastons through surrogates by saying that FDA approval is imminent when, according to his SEC filing, he apparently hasn’t even filed an NDA yet. As much as the BBC got right in its coverage of Burzynski, aspects of its Panorama episode on Burzynski were pure frustration to those of us who have been following Burzynski for a while.
I wonder if Brian Deer would be interested in looking into the Burzynski Clinic and the Burzynski Research Institute.