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Odds and ends left over after the Panorama Burzynski Clinic report: Burzynski versus his own SEC filing

I realize that I’ve been focusing on Stanislaw Burzynski the last couple of days, but it’s just been one of those weeks. Between the release of Eric Merola’s latest paean to the Brave Maverick Doctor and BBC Panorama’s report on Burzynski and his activities, it’s been an eventful week. My review of the second Burzynski movie and the Panorama report explain a lot, but there are some loose ends left over. So I might as well take care of that today before resuming regular blogging topics. (Yes, I know Stanislaw Burzynski is a regular blogging topic, but too much of a bad thing can get tiresome, no matter how much outrage I feel and express over his activities, leading to heapin’ helpings of not-so-Respectful Insolence.

As devastating as the Panorama story was, complete with Burzynski smirking his usual annoying, smug smirk and asking the reporter if he has Alzheimer’s disease because he’s asking him the same question (stay classy, Stash, stay classy), there were a lot of aspects dealt with little or not at all. First and foremost of those issues not dealt with whose absence was a huge mistake was the issue of the most recent FDA investigation of the Burzynski Clinic. It’s so bad that Josephine Jones is openly wondering 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 on 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 one of the odds and ends I wanted to touch upon, and it’s an issue 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 wil 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 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 whI 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 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 that “there can be no assurance that an NDA for Antineoplastons, as a treatment for cancer, will ever be approved by the FDA.”

That hardly sounds as though antineoplastons will be approved “soon.” After all, an NDA hasn’t even been submitted, and Burzynski is saying in his own SEC filings that he can’t predict 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, exaggerate, and even lie to the public, but lying on an SEC filing would carry serious consequences.

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.

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 dropoout 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.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

102 replies on “Odds and ends left over after the Panorama Burzynski Clinic report: Burzynski versus his own SEC filing”

Stan is basically stuck in a Catch-22 situation. Enough people are now aware that he has had long enough to gather ‘data’ and prove whether his treatment works or not, and what the side effect profile actually is. If he publishes, then he’ll have to properly reveal his protocols, and the real identity of the drugs (PA, PAG, PB, all of which are off-patent and can be bought easily), and then other doctors around the world can start using them, so nobody needs to come and pay him $$$$$$. If he doesn’t publish, or show enough evidence of efficacy, enough people are now suspicious that it’s no good (putting off potential patients), and the FDA can clamp down properly. In which case, no more patients and no more $$$$. Either way he loses, and hopefully thirty years of audacious claims and misled patients comes to an end.

Depending on whether or not Burzynski is listed as an officer of the company, he’s not “strictly” held to the statements in the SEC filing…..because of Sarbanes Oxley & other financial regulatory changes, the CEO / CIO of any company can be held criminally-liable for misinformation contained in any SEC filings (they are required to sign-off on all information as “factually accurate and correct).

Again, if Burzynski isn’t listed as an officer, he can say whatever he wants about ANP or any other treatments, since he’s not “officially” part of the leadership of the clinic.

Of course, it would be interesting to take a run at the new head of PR for the company to explain the discrepancies between what Dr. B has stated publicly and what the Clinic is telling to the Government (and potential investors).

If the Panorama team were aware of the SEC filings it would be unlikely to report them.

The programme is pitched at a certain level, a level which seems to decrease year on year, and trying to even explain what SEC filings were would take up a fair bit of time.

You’ll have noticed that the language/tone of the programme isn’t exactly high-brow. The target audience of BBC1 isn’t intellectuals or professionals. The content is made so that it’s understood by, and accessible to, as large an audience as possible, so that the channel can grab the largest audience share.

Although BBC1 do put out some absolute gold sometimes, it’s almost all from the Wildlife dept. We’re talking about a channel where, of the five largest viewing figures in the channel’s history, four of those slots are occupied by Eastenders.

They don’t want to turn viewers off by being too technical or in-depth, so Panorama’s “investigations” are, all too often, just human interest stories masquerading as hard-hitting investigative journalism. There are a few good episodes from the last few years, but even a stopped clock is right twice a day.

I’d love to see a full-length documentary into Burzynski on BBC4, or even a strong segment on Newsnight, Jeremy Paxman would rip Scamley up one side and down the other, but I doubt it will ever happen.

I really hope this is the end of the Piss-poor Protocol. Now if only someone could clamp down on his fantasy “gene-targeted therapy”.

A potential reason for a high dropout rate is that the patients may be unable to complete a full treatment (whatever that is), likely due to inability to pay. Not only is charging for participation in clinical trials unethical, it also screws up the study because financial limitation interferes. (And provides a delay before starting treatment that makes a handy excuse.)

If Burzynski really wanted to get these trials completed, he would set things up so that the barriers to enrolling were as small as possible. For these desperate people seeking hope, the biggest barrier — and what we’ve seen delays the start of treatment by significant months because of the up-front charges and then causes dropouts when they cannot continue to pay — is $$. And his mansion and I-came-here-with-nothing tale suggests that these costs and that barrier are significantly higher than necessary.

Several patient stories have mentioned the escalation in charges and additional fees as they progress. In some cases is seems to result in taking every penny they can raise, much sooner than they anticipated, and then forcing them to drop out. In some cases they suspend treatment while trying to get more money, which is hardly a way to test a protocol. It does make them easy to exclude — even from a collection of anecdotes — while taking everything.

Meanwhile, I’m curious how his pushing off responsibility onto others squares with him being the one who is personally paid rather than the clinic (or the treating physician). How are these funds classified (e.g. for taxation)?

Also not mentioned is that donations to the clinic are preferred by personal check made to DR B (or at least, that used to be the case). Dodgy as hell.

@Patricia – after reading through some of the financials, it certainly appears to be a pretty messy situation over there.

1) Burzynski owns the building where the Clinic is based & he charges the Clinic rent.

2) Burzynski also provides all of the operating capital for the Clinic, but charges back for (again rent) and other expenses related. This allows him to skim off any and all profits from the clinic in the name of “expenses” leaving them to report either a small loss or net-neutral revenue.

3) Members of the IRB (which are supposed to be Independent of the organization they oversee) are actually sitting on the Clinic’s Board of Trustees.

This is a very complex web of financial arrangements that allow the Clinic to operate, Burzynski to take all of the profits as “business expenses” related to the Clinic, and basically makes the Clinic report “Zero” Profit & not pay taxes on it.

Scary stuff…..

I predict that Stan will do a swift ass-covering exercise with the antineoplastons. He won’t publish his “results” (he doesn’t want to, obviously [presumably ANPs are useless] and if tried he’d be laughed out of the building), and so he thinks he can weasel out of presenting any meaningful data by pretending the nasty FDA has stopped him being able to.

Once this particular failed bridge is burnt he will be able to concentrate on his new scam, “gene targeted” therapy.

But “gene targeted” therapy is done through Caris testing and uses approved Big Pharma drugs (eg Tarceva etc), which come with huge cost and a raft of potential adverse effects. So he’ll quickly lose the support of the “no chemo”/alt-med brigade.

As SB is making lots of statements that run contrary to the information contained in the SEC statement he could be in real trouble for market manipulation. As a publicly traded company you can’t state “we’re doing great” when you’re doing lousy. It would be poetic justice if he goes down for SEC violations, like Al Capone went down on tax evasion charges.

I’m confused: a few minutes ago the entire 29 minute episode was there (I swear!); now it’s just a three-minute snippet that gets cuts off midstream. Did the BBC pull the entire episode for some copyright reason? This is very frustrating as I just set aside a half-hour to watch it.

Lawrence @2: IANAL, but don’t the liability provisions of Sarbanes-Oxley only apply to official financial statements of the company? He gives the straight story in the SEC filing because doing otherwise would be a felony. As for what he says to the public, there is an abracadabra involving the words “forward-looking statements” which he can invoke to make shareholder lawsuits disappear. Anything he says about putative publications or prospective FDA approvals would qualify as “forward-looking statements.” I haven’t checked his press releases, but Burzynski would be stupid not to take advantage of that loophole, and I haven’t seen any evidence Burzynski (or his lawyers, who should have pointed out this rule to him if he had been unaware of it) is stupid. Maybe he got careless, but I would expect that Burzynski has covered his posterior.

@Lawrence : thanks.

Though how does he pull claiming the money is expenses (and the clinic is responsible, not him) when it’s paid to him personally, directly by the patients?

And who owns his house? Building and maintaining that must be hugely expensive, hard to do that without personal taxable income. Or does he somehow charge that to the clinic too?

It seems the full Panorama episode is back up on YouTube at the link I posted above.

Patricia: in 2010, according to Harris County records I easily found online, his property taxes alone were over $100,000.

@Mu – depending on how the ownership is structured, you’d be surprised at what people can get away with…..

@Eric – if Burnzynski isn’t an “officer of the company” it really doesn’t matter, since he wouldn’t have to sign off on the financial statements.

In fact, in reading the filings, Burzynski is presented as more of a landlord / consultant, than an actual owner or partner in the company / clinic.

Then if he’s not actually part of the company, why does it say this on the Burzynski CLinic website:
“Donate to Clinical Trials & ResearchThe Burzynski Clinic accepts monetary dontations toward the continuation of the Clinical Trials and Research. You donate by check or Money Order payable to: S.R.Burzynski, M.D., Ph.D. Please note that donations are not tax deductible.”

A move to Mexico might be the next step. Tijuana here we come!

Ah yes, Brave Maverick Doctor (TM) forced to leave the US because of Big Government Interference (TM).

This has all the hallmarks of a continuing alt-med saga.

Then if he’s not actually part of the company, why does it say this on the Burzynski CLinic website

To maintain the illusion that he funds the Clinic’s “work” through his “private practice.” (I haven’t gone back to check whether Scamley’s signature actually appears anywhere on the 10-K.)

Burzinsky is an officer of the company, I took a look at the latest SEC filing. He is listed as the President and a Director.

OT – but is reportage of alt med fol de rol and ri-ra in Texas** ever truly OT @ RI?

At AoA today, Dan Burns outlines AJW’s appeal ( no, not THAT appeal- that one’s over and done with) wherein we learn that:
the BMJ attorneys resemble a tornado,
AJW’s rep, McBride, has a free legal clinic for parents of children in special education and has a child with ASD, AND
you can still donate money to help Andy.

“‘Science” blogs is mentioned and rather interesting similes/ metaphors are employed in both post and comment ( “get away car”, “get in bed”, “wriggle” et al).

** -btw- I am trying to figure out if Austin is in the crappy part of Texas or the really crappy part of Texas ( i.e, the steamy hot and,humid flood plane or the burnt out, inhospitable-to-life desert)? The map does very little good for me but I’d guess the former.

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 dropoout rate is a huge red flag. We don’t know the reasons for this dropout rate.

Andrea W’s story may give us a clue as to one of the reason’s for the high dropout rate:

On October 1 [Andrea’s] brain swelled massively, just as her flight home was beginning its descent. Henry Friedman, a neuro-oncologist at Duke University, and Victor Levin, a brain-tumor specialist at MD Anderson Cancer Center in Houston, and Boehm, her neurosurgeon, say she should never have traveled any distance from a hospital emergency room. Counters Burzynski: “It’s not up to us; that’s up to the local physician.” Boehm says the Burzynski clinic never called to ask him whether Andrea was fit to fly.

The patient history in Burzynski’s report to the FDA states that Walsh did not die under his care. She is listed as having withdrawn from treatment September 30, two days before she died. But according to the [W]s and [Andrea’s friend], a nurse, Andrea was still receiving antineoplastons just before she boarded the plane. “If she withdrew, why was she carrying a suitcase full of the medicine?” [her father] asks. Burzynski says he listed [Andrea] as having withdrawn on September 30 because that was the last day she was treated.

For further context, Andrea learned about 10 days earlier that her tumor had doubled in size. Burzynski told her she had to come down to the Clinic or she would be dropped. The day before she left the Clinic to return home, Burzynski told her that the tumor was breaking up, that it was shrinking. Her family then paid the standard $7,000 payment for the next months round of medication.

Denice Walter – Austin is actually in a fairly nice part of Texas. It is not as hot and humid as Houston, though slightly more so than Dallas. Winter is basically a non-event. Summers tend to be hot and dry, with high temperatures in the 30-41 C range. It’s reasonably green, though not as forested as east Texas. Normally it’s not nearly as arid as El Paso, though I understand that the last couple of drought years have taken their toll.

I think Austin is the best of Texas, the gateway to the beautiful hill country and home to my favorite bat colony. It’s wonderful, art and music based culture is peppered, like most culturally interesting places, with the credulous and fear-based. It’s a miracle that anyone survives a liberal arts education. I say that as a liberal and an artist.

Just reading these stories makes me feel sick, I can’t even begin to imagine how awful it must be for the families.

You know, Cancer sucks no matter who you are & who treats you….but, at least by committing to treatment options that have sound science & results behind them, you are giving yourself the best possible chances of survival.

There is a special place in Hell for the people that work with Dr. B and continue this charade for him…I won’t even mention here the “good doctor” belongs…..

As for Count Stan, what a reprehensible piece of work. If he’s delusional and well intentioned, that’s scary and awful. If he’s deliberately scamming, that’s worse. After seeing him speak in person, I can’t get his doppelganger’s voice out of my head . . . Phez vahn cleenical trial, mwa ha ha! Phez too cleenical trial, mwa ha ha! Phez tree cleenical trial mwa ha ha. . . .

It’s a miracle that anyone survives a liberal arts education.

Depends on what you mean by the term, I suppose.

And who owns his house?

A good question. I can only speculate, but it’s entirely possible that someone as savvy (or well-advised) and amoral as Burzynski might have incorporated himself. Not necessarily the same corporation as his clinic–if a corporation doesn’t have tradable shares, they don’t have to disclose anything to the SEC.

I know a guy, who coincidentally lives in Houston (I have no idea whether he and Burzynski know each other), who, along with his siblings and parents, incorporated his family. Among other things, that lets them write off one family gathering–excuse me, Board of Directors meeting–per year. (Or at least it did at the time he mentioned this corporation to me.)

There are a few states more corporate-friendly thanTexas, but not many. (Delaware, of course, was the winner of that race to the bottom.)

My stomach is turning reading these patient stories too, the people are already so desperate and then the demands pile on. I’m also starting to think that the high dropout rate isn’t a bug, it’s a feature.

@Bob – “Buffy – the Anti-Vax Slayer!!!” Yay!!!!

Good for her, glad to have her on board!

SEC filing talk. For once, something in my wheelhouse.

“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 that “there can be no assurance that an NDA for Antineoplastons, as a treatment for cancer, will ever be approved by the FDA.”

Those lines are more or less boilerplate in SEC filings for companies with drugs in clinical testing. I’m working on one currently in a Phase III that we know works (currently approved outside of the US) and in all likelihood will be approved in the coming years, and we still have similar lines in the SEC filings. Just because… you don’t know. Something might come up, something you didn’t expect, and against all logic, the trial fails. Negative language is in there to protect you from investors. If the trial fails, you want to be able to point to the filings and say “Look, see? We told you it might fail”. If you put in assurances that it will pass, and for whatever reason it fails, you end up in trouble with the SEC and your investors.

The best you can usually do is to say “While we expect that we will be able to file an NDA by [Date X], there can be no assurance, and we may never be able to file an NDA for [Drug Product Y]”

(the above is not to say I think that Burzynski is legit. In my opinion, he’s the worst kind of quack. But I don’t necessarily think conclusions can be drawn just because of language in his SEC filings)

@Andrew – I find most SEC filing to be so full of boiler-plate language as to be nearly useless for deciphering real information from them….

Eric Lund and Patricia,

According to tax records (link below), the house is listed in his name and his wife`s. No fancy incorporation sleight-of-hand here.

And his property taxes have gone down in the past few years. This year he only owes $86,000. The appraised value of the house and land have also gone down, now sitting at $4.35 million from a high a couple of years ago of close to $6 million.

You can look back at the past few years of tax history here:

Looking at the comments on CNN makes me appreciate what we see here.

Apologies for the OT cross-post (though are anti-vax antics ever OT here?) but Slate’s Bad Astronomy blog just posted a long piece about RFK Jr.’s antivax tendencies:

Lilady and Lawrence, heads up…I can’t see any AoA bots in the comments yet, but they will no doubt turn up. There are some jabs (ha!) at AutismOne and St. Andy Fakefield in there too.

I wonder how many people went through his clinic to buy that $6 million house and how many survive today.

@Edith Prickly

Phil Plait and his regulars can handle the anti-vaxxers pretty well. That’s actually where I got started before I began reading RI more regularly. It’s also where my site had its first iteration.

@Todd – unfortunately, the volume of comments now over at Slate makes it nearly impossible to track and comment what is being written about. I still love it & Phil is definitely on my Hero list.

  • I Observed your talk with Martin Vizzard yesterday
  • a lot of smart people her so I maybe you don’t need my input, about why SB is BS and why it matters
  1. Breaks the too Good/Bad to be true rule, (it is possible for a small clinic to be be innovative, but 20 without acceptance is too long)
  2. NO Method Explanation : Lack of accepted scientifc explanation for the method
  3. NO PROPER Evidence (replicated multiple times, randomised, double blind studies)
    Usually 3. validates 2. .. Now occasionally the results come first, and then the science is worked out later, but 20 years with no NO PROPER Evidence published is unbelievable
  4. Moral argument : What real Jesus keep his miiracle technique secret ?

– So does SB work better than chance ? NO ALMOST CERTAINLY NOT

WHY It Matters
When people believe in “alternative Medicine” SOME stop taking is REAL MEDICINE
( over the group it becomes HARMFUL to overall heath.)
He sucks money away from real research : Campaign money raised to send UK kids to his clinics might otherwise go to real charities

  • We saw from Martin that they are not promoting it as a MAGIC SOLUTION, but just say “there is a chance it can help” so sucking people in. Now we now that in any sickness a certain percentage will get magically better whatever happens and that is the game that SB is playing
    ..”look A-F died, but G & H have lived 5 over years”.. Now we know that would have happened ANYWAY
  • And he is helped by this “Not Pure enough justification” effect (when something fails people post justify it by saying “It works, but I just didn’t do it early/thoroughly enough”)

  • 2 other points

  1. CANCER DOES NOT KILL US ..It’s life that kills us. We are sure to die, but sometimes sickness brings the end earlier than we might like.
    2. GREAT PAIN Treatment available now, so people like Martin don’t have to suffer pain like years ago
  • So while he is right to research opportunities of Genuine clinics. He should not feel the guilt of “I did not nothing”, because the odd of spontaneous remission are within Normal medicine are greater than with “alternative Medicine”

Orac – maybe I am stupid
Patients Dying would explain a high number of drop out rate in the studies. They are usually coming to SB as their last chance. So we are not hoping he can get a 95% cure rate , but something statistically higher than chance.

..typo above “20 YEARS without acceptance is too long”

“- Patients Dying would explain a high number of drop out rate in the studies”

Surely patient dying and reasons for death are things that any study would be keenly interested in recording and presenting as results. Seems more likely that people are dropping out either because they’ve heard bad words about the clinic or they’re bled dry financially before they can complete.

Adam, we’ve had at least one report where a patient who died a couple of days after being treated by Burzynski and three days after purchasing a month’s supply of medicine was classified as “withdrawn from the study” (see my earlier comment at 26). She didn’t even manage to get home from her last treatment before she had to be rushed to the hospital. There is certainly a large number of people dropping out, but if what Andrea’s family says is true, Burzynski is cooking the books by claiming some dead patients as unevaluable when they were still on his protocol. Let’s be frank – if the allegations are true, he is engaging in research fraud (and quite possibly monetary fraud, since he’s reporting results in his SEC filings).

Which may be why he doesn’t publish.

here’s a link to Andrea W.’s story

Burzynski says he listed [Andrea] as having withdrawn on September 30 because that was the last day she was treated.

Apparently, patients are only enrolled in a study while they’re physically present and receiving treatment at the clinic. If they’re sent home with a few week’s supplies of ANP’s for self-administration they’ve been withdrawn from the study (until their next clinic appointment, presumably,, when suddenly they’re re-enrolled).


Unfortunately, Slate’s commenting system makes it nigh impossible to follow any conversation. Much preferred when he was over at Discover. But, yeah, it seems the conversation has largely veered off of RFK Jr.s’ anti-vaccinationism to focus on piddly tangent topics that were not the main thrust of Phil’s post (e.g., GMOs, imagined political motivations, etc.).

I am not fond of Slate’s commenting system either. Plus, Bad Astronomy already has a resident “Chris” who says exactly what I would say, only with more wit.

Surely patient dying and reasons for death are things that any study would be keenly interested in recording and presenting as results

This would be true of an honest study where the researcher is seeking the truth.

A new ANP activist/propaganda website has sprung up:

It’s paving the way for the establishment of foreign or overseas antineoplaston clinics and is asking for donations to help fund treatment for people who cannot afford it.

After 35 years of the inventor, the supporting medical community, and his patients trying to convince the American government and regulatory agencies to be allowed to freely participate in the drug approval process within our so-called “Free Market”, it has become apparent that seeking refuge in a non-American country to create a massive tourism industry for cancer patients may be inevitable.

Whether this fight is won in America, or won overseas, one thing is certain—the only way this fight can be won is if the majority of the world’s population understands the problem, and understands what Antineoplastons are.

If the United States still refuses to allow Antineoplastons into its marketplace, we will then make sure another country will be properly funded to set up the proper channels for Antineoplastons to be approved for their marketplace. Another avenue would be simply opening up a massive Antineoplastons clinic allowing the cancer patients of the world to seek treatment using Antineoplastons.

Upon gaining either market approval—or the funding the construction of an Antineoplaston clinic overseas, our funds will then go to make sure everyone who cannot afford to travel overseas to receive Antineoplaston therapy—can do so by requesting money through this organization.

@MSII – I wonder if that’s the reason old Stan keeps pumping out the ANPs by the gallon?


Maybe he’s building an ANP pipeline from Houston to Tijuana even as we speak?

But seriously, during the Q&A after one of the recent screenings Merola, Mini B. and the minions on stage implied moving to an overseas clinic might be inevitable if the FDA opposition is insurmountable. And that would be the best thing to happen, as trying to lure patients to Mexico, Brazil, Poland or Costa Rica would be much more difficult than getting them to Texas. Houston has the cachet of being in the USA, where there’s a perception that cutting-edge technology and modern facilities exist. I imagine it would be a tougher sell in the UK, for instance, to get families to raise hundreds of thousands of pounds to go to Mexico, home of quacks like Hulda Clark’s and Gerson’s clinics, or Brazil, where John of Fraud plies his trade.

Do you remember the recent stem cell thread where a “journalist” shill piped in to plug a clinic in Mexico? She writes for a “medical tourism” magazine backed by ta consortium of worldwide dubious clinics promising treatments not available (for good reason) in the US. I imagine Burzynski would quickly jump on that bandwagon if he is forced to relocate out of Houston.

More than likely he’d simply retire and hand control over to Mini B. to continue the family con.

Looks like the neoplastin pipe in the US has been turned off, and if the FDA is still run by scientists, it will not be turning on.

Habla Espanol Stan?

The other option is to go with the Gene targeted therapy route using off the shelf therapies. Doesn’t have quite the “Maverick Doctor” appeal.

And that would be the best thing to happen, as trying to lure patients to Mexico, Brazil, Poland or Costa Rica would be much more difficult than getting them to Texas.

Not to mention the expense of having to relocate the signage.

I was just watching again one of my all-time favourite movies, when one of the scenes put me in mind of Dr B. It seems an appropriate metaphor for Dr B’s business methods.

One difference is that in this scene, Tuco (“The Ugly”), although ruthless & amoral, is not running over the graves of his own victims to find the buried gold.

Burzynski has worked his ass off for over 30 years and has cured cancers that other wise couldn’t have. Its funny you all say how there is adverse reactions to his treatment. Wow a few people had reactions. How many people have had reactions from radiation? Ummm duh radiation will kill cancer lol radiation will zap the hell out of anything. Parasites, viruses, cells, animals duh. Radiation in isolated amounts is the best we can come up with. Zap an individuals immune system when the immune system is obviously compromised in the first place. Its funny that you all cannot see behind the veils. You trust cnn, fox, and the worst ….the FDA. You so easily say things like…. Is this FDA approved?? Well what does that mean and do you not have any concern about pharmaceutical companies paying the FDA for faster drug processes. How is the cure coming? Also if we found a cure for any disease what would happen to all those profits for these companies when the whole world was cured? What would these stocks to if a cure was actually found? The cure is already out but unfortunately there is no money in cures. Wake up people seriously get your head out of the cinnamon toast crunch commercials, drop the dove soap you wash with and stop listening to big industry. Your reality is based on a severely broken system that pays large sums of money to control, and sway public opinion. Or maybe whole grain lucky charms are magically delicious right? Im sure half of you would buy a box today if the FDA approved them as cancer treatment. Wake up for real do research outside of webmd, and all the mainstream research organizations. If you start putting pieces of the puzzle together you can see it clearly but you have to change your sources to find it. You will not find the answers in mainstream media or institutions. Everyone is paid off.

Jared –

  1. How do you know that Dr. Burzynski has a cure for cancer?
  2. Where is the high-quality data that shows how his treatment compares to the standard of care.
  3. Why is this so important to you?


@Jared Anderson – Let’s suppose as you propose that Whole Grain Lucky Charms were found by the FDA to be a safe and effective cancer treatment. That would mean that there would be a significant body of evidence published and reviewed that said While Grain Lucky Charms were a safe and effective cancer treatment, with specific descriptions for the types of cancers that it can be used to treat and how it can be used for that. If it were a safe and effective treatment for a particular cancer, and you had that particular cancer, and it remained as inexpensive and easy to obtain as it is now – why wouldn’t you buy a box? It would seem that turning your back on a proven cheap, safe, effective cancer treatment just because it’s a product of a large food company that advertises a lot would be, well, foolish.

I personally am not willing to accept that some brave, maverick doctor has a cure just on his/her say so.


Wake up for real do research outside of webmd, and all the mainstream research organizations. If you start putting pieces of the puzzle together you can see it clearly but you have to change your sources to find it. You will not find the answers in mainstream media or institutions. Everyone is paid off.

I have been involved in medical research, and have known many people, doctors, professors, PhD students and others involved in medical research over the years,. and I have never heard as much as a whisper about anyone being paid off, or suppressing any cures for anything at all. I have heard a lot of grumbling about the lack of money for research grants and fixed term contracts, but conspiracies? Nothing, even when these people have had far too much to drink, and you might think they would spill the beans. Either these people are very good at keeping secrets, and I was never accepted into the inner cabal, or there is no huge conspiracy.

Where do you recommend looking for the answers? Let me guess. Natural News, If you believe them, any information they don’t agree with is from people who have been paid off, and the lack of information to support their claims is because it has been suppressed by people who have been paid off. You can prove anything, from alien abductions to 9/11 conspiracies if you accept this kind of “research”. You should open your eyes and see that you have been misled into believing nonsense.

Oh, I almost forgot the requisite “lol duh” and “baa”.

Yawn another drive by troll spouting the same old nonsense of looking for answers on Google U.

The people who tell us not to trust mainstream media / governmental sources provide ALTERNATIVE MEDIA services: they dream up stories that capture the audience’s attention in order to sell advertising, so-called “educational resources” ( books, films, radio channels) and products such as supplements, food, food preparation machines, water filters etc. Usually they include a page called “Store” and some even unabashedly ask for “Donations”. Thus they are not informing us out of the goodness of their hearts or out of any respect for veracity but because they want to make money off of their readers.

And how do I know this? Because I have surveyed some of the most prolific dens of iniquity for many years and have seen how they have been transformed from purely health concerns to more far-reaching topics ( including economics, politics, general conspiracy mongering) in order to capture readers’ attention in any way they could.
In order to make readers believe that they are providing them with beneficial information and that they are “on their side”.

So that they can sell ad space or products. They masquerade as useful information or as news to hide their prime motive: selling products as well as hope and dreams whilst selling their own personae and creating a career for themselves.

The likes of Jared presumably don’t know any scientific researchers, and imagine we are all either evil geniuses cackling about our world domination plans over bubbling test tubes, or nerdy wimps too afraid of our evil genius (reptoid) masters to say a word about the natural cures we routinely suppress.

That’s why from time to time I trot out my experiences working and socializing with scientific researchers, who are for the most part decent and relatively normal people, and how I have never heard a squeak about any such conspiracies. It’s a somewhat futile whackatroll exercise, but I have a vain hope it might sometimes do some good.

Multiple Burtrollskis on both SBM and RI the past couple of days. One wonders if Orac’s TAM talk has ‘ol Stan & Co. worried, one does… 🙂

Why are you all so paranoid about Burzynski? Are you all in fear of losing your jobs or potential income? He must be doing something right as he was granted the right to run clinical trials. His methods can’t be any worse than the torture, sickness and death that has occurred from the miserable, outdated and useless chemo and radiation treatments. Let’s face it folks, no matter how you spin it, those methods are useless and archaic. THEY DON”T WORK!!! Only for a few cancers and even then, the cancer comes back with a vengeance in many cases. Let’s stop harassing and trying to prevent someone who is actually trying to do something to actually treat and possibly wipe out cancer. God knows it’s not coming from any pharmaceutical company and yes, I do know what I’m talking about…I worked in clinical drug trials for a major pharmaceutical company. Would you like one of your loved ones to go through the horrendous ordeal of chemo or radiation therapy…or if it were you, would YOU choose to go through that misery rather than a treatment that has no where near the horrendous side effects of the poisonous chemo and radiation? I myself would do anything I could to get to Burzynski’s clinic rather then let them inject me with that poison. Face the facts…time for a BIG change in dealing with cancer and many other diseases that Big Pharm is making huge profits from.

Well said Francine! I was diagnosed with breast cancer 4 years ago & endured 6 rounds of chemotherapy. I was violently ill from the poisonous mix of several drugs that was pumped into my body. None of these drugs were new or innovative. Just the same old poisonous, cookie cutter regime that’s been used for decades & gets given to everyone that has similar breast tumor pathology. These drugs have a long list of very unpleasant side effects and can cause deafness, neuropathy, loss of taste, irrepairable damage to organs & heart muscle as well as the added benefit of potentially causing leukemia down the track. That’s just naming a few….
You know what, Bursynski may not be the answer for everyone but as an adult I should have the choice of what treatment I wish to pursue & how much money I want to spend on it. It’s my choice about my health. I should’nt be forced into an outdated & clearly ineffective treatment plan just because Big Pharma says so. I know how much money Pharmaceutical companies make as I was employed by them for many years. It’s all bullshit. It’s not about wellness, it’s ALL about profit!!!!

I notice you complain about the side effects of your cancer treatments, but you show no gratitude whatsoever to your oncologist for saving your life. I firmly believe that if you had used Burzynski’s treatments instead you would very likely be dead, like many other of his patients. If you were very lucky you might have joined the few other survivors of his perpetual and never-published clinical trials as walking commercials for his clinic.

You know what, Bursynski may not be the answer for everyone but as an adult I should have the choice of what treatment I wish to pursue & how much money I want to spend on it. It’s my choice about my health. I should’nt be forced into an outdated & clearly ineffective treatment plan just because Big Pharma says so.

You don’t think people should have to prove that a cancer treatment is safe and effective before selling it to people? Why hasn’t Burzynski published his clinical trial results? Have you read
Orac’s post
that describes how Burzynski’s lawyer cynically exploited loopholes in the law to allow him to open numerous clinical trials he has no intention of ever publishing.

I know how much money Pharmaceutical companies make as I was employed by them for many years. It’s all bullshit. It’s not about wellness, it’s ALL about profit!!!!

Did you and francine work for the same pharmaceutical company? If so you must know how competitive they are, and just how much money a pharmaceutical company can make from a successful cancer treatment. Genentech makes over $1.2 billion every year from Herceptin, for example. Why would any drug company suppress an even more successful cancer treatment? It could put their competitors out of business for good.

Kat, francine,

Surely one of you can tell me, then, where the convincing, independently replicated evidence from well conducted studies published in peer reviewed journals that any of Dr.Burzynski’s treatments are better in any objective sense than the current standard of care.

FWIW – I’d just as soon every treatment that said it could cure cancer better than surgery, radiation, and chemotherapy were actually safe and effective, as I receive no income from the existing stable of treatments. However, I believe that before you start selling people something that is supposed to be a cure, it should be proven safe and effective at least as rigorously as existing drugs were.

Frankly, I’m surprised that you aren’t concerned that people may be throwing away good money on ineffective treatments. At least in your case, Kat, can I presume that the treatments that you dislike so much (and I can see that they were very unpleasant) may have actually done you some good?

Krebiozen – you need not take my opinion as a lack of gratitude! I was given no other option or treatment plan by my oncologist other than the one carried out & I stuck religiously to her plan. I have a very healthy respect for my Oncologist. That doesn’t mean I can’t have opinions about the treatments used. Everyone is entitled to their own thoughts & opinions given that we are on a free speech forum.

Mephistopheles O’Brien – I am still breathing today, so yes, I guess you could say that it was a preferable outcome. However, I would not say the treatments were good for me. I’m not going to bore everyone with the list of side effects I had the misfortune of experiencing. We all now how unpleasant chemotherapy is. Lets face it………it’s toxic poison. Researched or not!

There is always an argument fore & against most things in life. I have watched both Bursynski documentaries & done lots of research & reading on his & other alternative methods. He does not promise cure. Neither does standard treatment of chemo or radiation. All treatments are a life extender, not a cure. My Onc tells me that people who’ve had cancer are NEVER out of the woods as their original cancer can flare 10 or so years after their original diagnosis. I just feel that people should be able to choose a method of treatment that they feel could be of benefit, no matter how outside the square it is. If you have exhausted standard methods & could benefit from an alternative treatment, why wouldn’t you try it? Brain cancers seem to be where Bursynski has had most success & standard treatments have failed miserably. Are the skeptics implying that the success stories that Bursynski’s patients share are liars?

I’m upset that the FDA has shut down the use of Antineoplastons. Who is it hurting? If people wish to spend top dollar on it, it’s their prerogative. We know without a shadow of a doubt that tobacco causes lung cancer & that fatty fast food contributes to heart disease but you don’t see people shutting down the doors of Phillip Morris or KFC & McDonalds.

Also chemo is NOT safe or overly effective. Thousands of people die each year from the side effects of Chemotherapy & not their actual cancer. If chemo is so effective, why are people all over the globe dying from cancer?

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