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Stanislaw Burzynski’s propaganda victory on antineoplastons: The FDA really caves

It’s been a while since I wrote a substantive post for this blog about the Houston cancer doctor and Polish expat Stanislaw Burzynski who claims to have a fantastic treatment for cancer that blows away conventional treatment for cancers that are currently incurable. The time has come—and not for good reasons. The last time was primarily just a post announcing my article about Burzynski being published in Skeptical Inquirer. When last we saw Stanislaw Burzynski on this blog, it was a post that I hated to write, in which I noted that the Food and Drug Administration (FDA) had caved to patient and legislator pressure and allowed compassionate use exemptions (otherwise known as single patient INDs) to continue. The catch? Cynically, the FDA put a condition on its decision, specifically that no doctor associated with Burzynski nor Burzynski himself could administer the antineoplastons. This set off a mad scramble among Burzynski patients wanting ANPs to find a doctor willing to do all the paperwork and deal with Burzynski to administer ANPs. The family of one patient, McKenzie Lowe, managed to succeed.

It’s hard for me to believe that it’s been almost three years since I first started taking an interest in Burzynski. Three long years, but that’s less than one-twelfth the time that Burzynski has been actually been administering an unproven cancer treatment known as antineoplastons (ANPs), a drug that has not been FDA-approved, to patients, which he began doing in 1977. Yes, back when Burzynski got started administering ANPs to patients, I was just entering high school, the Internet as we know it did not exist yet (just a much smaller precursor), and disco ruled the music charts. It’s even harder for me to believe, given the way that Burzynski abuses clinical trial ethics and science, that I hadn’t paid much attention to him much earlier in my blogging career. After all, I’m a cancer surgeon, and here’s been this guy treating patients with advanced brain cancers using peptides that, according to Burzynski, do so much better against what are now incurable tumors than standard of care while charging huge sums of money to patients on “clinical trials.” It might be a cliché to quote the Dead this way, but what a long, strange trip it’s been. Because there has been a major development in this saga whose context you need to know to understand, I’m going to do a brief recap. Long-time regulars, feel free to skip the next couple of paragraphs, as they just try to bring people up to date and include a lot of links for background, or, if you haven’t already, read this summary of Burzynski’s history published earlier this year in Skeptical Inquirer. Newbies, listen up. Read the next two paragraphs. You need to know this to understand why I’m so unhappy.

Incidents that I never blogged about here (but fortunately a certain “friend” of mine did on another blog) that have occurred since the FDA caved and (sort of) lifted the partial clinical hold on ANPs included:

  • For the first time in 37 years, Burzynski published what was purported to be the complete results of one of his phase I/II clinical trials. The results were—shall we say?—underwhelming.
  • Before that Burzynski had published 42.5% of one of his phase I/II trials, with even more unconvincing results.

Meanwhile, since he received that warning letter from the FDA late last year, in addition to making unconvincing claims excusing the issues described in the FDA warning letter, he’s been trying to enlist patients, both cute children and the semi-famous, to persuade legislators to pressure the FDA to let his clinical trials open again after they had been put on a partial clinical hold in the wake of the death of a child from hypernatremia (too much sodium in the blood), as reported by Liz Szabo in USA TODAY. All the while Burzynski has continued to charge patients large sums of money, while bragging that he didn’t charge for the actual ANPs. For those unfamiliar with the story, a partial clinical hold means that Stanislaw Burzynski can’t enroll any new patients on clinical trial but can continue to treat patients already enrolled.

Yes, three months ago—has it been that long already?—I noted with dismay that, under the onslaught of sympathetic cancer patients who understandably but incorrectly believe that Burzynski is their last chance to live, the FDA did indeed cave, although in the most weaselly way imaginable, stating that Stanislaw Burzynski could again enroll patients under compassionate use exemptions (also known as single patient INDs), even though the FDA warning letter had found gross deficiencies in the Burzynski Research Institute Institutional Review Board (BRI-IRB), which is run by an old crony of Burzynski’s who just so happens to be chair of the board of directors of the BRI and was found to be negligent in protecting patients by playing fast and loose with the regulations for enrolling patients on single patient INDs. The condition was that Burzynski himself or anyone working for him couldn’t be the physician treating the patients, leaving the patients to find a doctor willing to oversee the administration of ANPs.

And so it was for three months, with desperate patients with terminal brain tumors scrambling to find some doctor willing to do the paperwork to get the FDA to allow him to administer ANPs and also willing to work with such a disreputable character. McKenzie Lowe’s family, for instance, managed to find a retired family practitioner named Terry Bennett to agree to this. (More on this later.) Then, last week, this bombshell landed, courtesy of Liz Szabo again, in a story entitled “FDA gives controversial doc green light to restart work“:

The Food and Drug Administration has given a controversial Houston doctor the green light to resume administering experimental cancer treatments.

The FDA has lifted restrictions on a clinical trial run by Stanislaw Burzynski, who was the subject of a USA TODAY investigation last year. Burzynski, 70, has wrangled with state and federal medical authorities for nearly 40 years over his claims that he has discovered natural substances that can fight certain cancers.

You might think that my reaction upon reading this would be “WTF?” It wasn’t. However, that was only because I had had that reaction a week ago, when I read a press release from the BRI, “Burzynski Research Institute, Inc. Announces Lifting Of The FDA Partial Clinical Hold – Phase 3 Clinical Study Agreed Upon“:

The Burzynski Research Institute, Inc. (BRI) announced today that U.S. Food and Drug Administration (FDA) has notified the company that its partial clinical hold on its IND for Antineoplastons A10/AS2-1 Injections has been lifted. The FDA has determined that under its IND the Company may initiate its planned Phase 3 study in newly diagnosed diffuse, intrinsic, brainstem glioma. The Company is continuing discussions with the Agency in an effort to finalize additional details of the phase 3 study protocol for the potential clinical trial.

The FDA’s decision to lift the clinical hold marks an important step in the development of Antineoplastons for the treatment of various forms of brain tumors in the US. At the same time, the Company is evaluating possible next steps for the Antineoplastons clinical program given the current progress and anticipated resource requirements of the ongoing program.

That was when I had my “WTF?” moment. However, noting the obviously intentionally vague language of the press release, I decided to wait until I could learn more and obtain confirmation rather than to blog the press release. For one thing, Burzynski could have just been spinning furiously, and there could have been a lot less to this press release than met the eye. It wouldn’t be the first time. Also, I just couldn’t believe that the FDA would so horrifically fail patients with brain cancer yet again the way it now has. I could sort of see why the FDA issued its previous ruling that allowed other doctors to enroll patients in single patient INDs of ANPs. At the time, the FDA was under a lot of pressure from legislators being contacted by constituents about families in their state or district with brain cancer who wanted to be treated by Burzynski. Its cynical solution must have seemed downright Solmonic at the time to the administrators who thought of it. But this? There’s nothing in the press release that says that the conditions that led to the partial clinical hold were resolved. Yesterday, however, there was this in Szabo’s story:

In a statement issued Wednesday), the FDA confirmed that it has lifted its restrictions on Burzynski because he answered all of their questions. In particular, Burzynski addressed “common and serious (and in some cases fatal) adverse drug reactions, as well as accurate information on how often tumors shrink after treatment with antineoplastons.”

Notice something missing? I did. The FDA said nothing about the BRI-IRB, which was soundly chastised for approving single patient INDs without full meetings of the committee. It also said nothing about the massive conflicts of interest that exist in the IRB and how it can’t possibly be independent. Sure, if Burzynski talked the talk adequately, I might see how the FDA might be either snowed or too tired to fight any more. I could see how it might be tempted to let him open his bogus clinical trials again—but only if Burzynski were forced to use a truly independent IRB, not his crony-packed IRB that basically rubber stamps whatever it is he wants to do with no questions and no evident effort to protect the welfare and rights of clinical trial subjects. Any IRB worth its salt will refuse to approve a clinical trial now and then and/or issue warnings to principal investigators for inadequate documentation, too many adverse events, etc. Has the BRI-IRB ever done this? Not as far as anyone I know can tell. Of course, it’s not really up to the FDA to oversee the function of IRBs. Rather, it’s more a function of the Office of Human Research Protections (OHRP). Long have I wondered: Where the heck has the OHRP been all these years?

It’s not as though Burzynski isn’t up to his old tricks again, either. Even with another physician overseeing the treatment of McKenzie Lowe, he’s managing to find ways to charge patients huge sums of money, even as he isn’t charging them for the ANPs. Indeed, the other day, Dr. Bennett, the physician who is overseeing the treatment of McKenzie Lowe whom I mentioned near the beginning of this article, was featured in an article in a local newspaper “Dr. feels misled in cancer treatment costs“. The money quotes are here:

But there was something Bennett didn’t know.

Bennett’s decision was based, in part, on a newspaper article that said Burzynski had agreed to donate the medicine required for McKenzie’s treatment. But what Bennett didn’t know is that Burzynki [sic] planned to charge the family for the clinical costs associated with the therapy.

LaFountain said the first month’s bill is expected to be $28,000. Every month after that is expected to cost $16,000. The treatment usually lasts eight to 12 months.

And health insurance won’t cover a dime of it.

And here:

Bennett says a representative of the Burzynski Clinic called him on that date seeking payment for the first month of McKenzie’s therapy. Prior to that, Bennett, who is donating his services, thought Burzynski was doing the same.

Instead, said Bennett, “I’m supposed to be the bag man for all of this. They want me to collect the 30 grand for the family and send it to Burzynski.”

Elsewhere, Bennett said, “It [the Burzynski Clinic] meets all the criteria for a bait and switch operation.” Yes, even Dr. Bennett found out the hard way how the Burzynski Clinic operates. None of this is anything new. Burzynski has been trying to dodge this tactic for years by saying that he doesn’t charge patients for his actual drug, the ANPs, giving the impression that he’s not charging them much of anything. However, the reality is that costs can rapidly add up to hundreds of thousands of dollars, which is why fundraisers by families of Burzynski patients have been a feature surrounding the Burzynski Clinic operation for decades, as has been documented time and time and time again.

This is a doctor who wants to help and is willing to take risks, even if inappropriately in this case, and he feels used by Burzynski. Indeed, his comparing himself to a “bag man” is a particularly apt metaphor, because that’s what he is in this: A bag man. It’s his job to collect the cash from the family of a dying child and ship it to Burzynski. Ironically, this news story appeared on the very same day as Burzynski’s press release, and, of course, Szabo’s story appeared yesterday. Did the FDA know Burzynski was doing this? It strains credulity to think that the FDA didn’t know about this abuse of a desperately ill child’s family, given that information regarding how it will be paid for is part of a single patient IND application, indeed part of all clinical trial applications. Indeed, that Burzynski gets away with this is yet more evidence that his IRB is nothing more than a rubber stamp, because any independent IRB would ask some very hard questions about such an arrangement. Very hard questions indeed. It’s painfully obvious that the BRI-IRB has never asked hard questions any IRB should be asking about any clinical trial Burzynski has proposed or about how his clinical trials are being carried out.

It’s even worse than that, though. Check out what I found on a website devoted to penny stocks, “Burzynski Research Institute (BZYR) Reignites On FDA Approaval” [sic]:

Focusing since 1967 on the isolation of various biochemicals produced by the human body as part of the body’s possible defense against cancer, the penny stock of Burzynski Research Institute, Inc. (BZYR) has exploded on the scene thanks to the efforts of CEO and President Stanislaw R. Burzynski, M.D., Ph.D. After notification that the U.S. Food and Drug Administration lifted its partial clinical hold on its IND for Antineoplastons A10/AS2-1 Injections, shares of BZYR stock begun to trade and are putting on a good show thus far. Although only around 25 million shares issued and outstanding do not belong to the founder who is determined to treat of various forms of brain tumors, the large jump upwards has made this little biotech burz-worthy.

You know, with all the typos and English that sounds as though it were written by someone who isn’t a native English speaker, this made me suspicious that Burzynski or someone from Burzynski’s clinic wrote it. Either that, or the web page is written by non-English speakers, which seems likely given that I found the same sorts of weird-sounding sentence constructions in other articles and I know Burzynski’s people can produce serviceable English prose when they need to. Be that as it may, I have little doubt that the Burzynski clinic is trying to take advantage of the FDA decision to bolster its flagging finances, which have been reportedly hurting since the partial clinical hold was placed. Whether this article on a website hawking penny stocks has anything to do with it, I don’t know, but its appearance right around this time sure doesn’t seem coincidental to me.

So what happened? Why did the FDA cave so ignominiously? How could it ignore 37 years of Burzynski’s therapeutic misadventures and abuse of science and the clinical trial process? I have a few ideas, but none of them are satisfying, and all of them are speculation, ranging from educated to, well, just speculation. Back in the 1990s, it was powerful legislators like Joe Barton leaning on the FDA to let Burzynski be Burzynski. Today, there are no visible and obvious champions in Congress for Burzynski. Even so, that doesn’t necessarily mean that such congressional patrons don’t exist, given the campaign waged by patient families and the Burzynski clinic to get people to write their Congressmen and Senators. Another likely possibility is that the FDA is just tired. If it shuts Burzynski down, it will be portrayed for years as the bad guy denying patients a chance at life, and there will be an enormous court battle. If it decides to fight, the FDA could end up with years of litigation, and, given the FDA’s unfortunately limited budget, it has to pick its battles. Does it help the FDA’s mission overall if it drains so many resources fighting what it likely views as small fry like Burzynski that it finds late in the fiscal year that it can’t afford to go after a large drug company over lack of resources? I don’t know, but given how long Burzynski’s been at it, the FDA’s decision is still an extreme dereliction of its duty to the public.

Whatever the reason that the FDA caved, we’ll probably never know. We can make FOIA requests, but the FDA is notoriously tight with the information it permits to be releases because it’s forbidden from releasing information that might endanger trade secrets of the companies it regulates and it appears to take a fairly expansive view of what constitutes such information. At least, we’ll probably never know unless we can get a powerful Senator or Congressman (or two) interested and as outraged as we skeptics are. A Congressional investigation, as unlikely as that sounds, is probably the only thing that will get to the bottom of the FDA’s utter failure. It’s clear that in this case the FDA is no longer able or willing to protect the safety, finances, or rights of patients with advanced cancer.

Posted in: Cancer, Clinical Trials, Politics and Regulation

Leave a Comment (55) ↓

55 thoughts on “Stanislaw Burzynski’s propaganda victory on antineoplastons: The FDA really caves

  1. Eldric IV says:

    What exactly is “the talk” referenced in the addendum?

    My residency having just ended, I am in the fortunate position of being in Missouri at my brother’s house. He is in the fortunate position of being a voting Missouri resident. A phone call is in our future.

    1. David Gorski says:

      What exactly is “the talk” referenced in the addendum?

      A failure to edit it out of the piece, which I modified from a post that appeared elsewhere last week.

  2. Bob Blaskiewicz says:

    The Senator’s office was quite helpful and the Skeptics for the Protection of Cancer Patients facebook group will be following up with them. Thanks everyone. It was a great meeting.

        1. Joey says:

          Yes, I get the point quite well. You don’t accept the fact that kids with brain tumors are getting bettor outcomes with ANP.

          1. Chris says:

            Only because there is no real evidence!

          2. Windriven says:

            “You don’t accept the fact that kids with brain tumors are getting bettor outcomes with ANP.”

            That “fact” is not in evidence. If someone can demonstrate with scientific rigor that ANP treatment improves outcomes for ANYTHING, we would accept that and be happy for the lives it would help. But given the facts in evidence to date, we aren’t holding our collective breath.

          3. WilliamLawrenceUtridge says:

            You don’t accept the fact that kids with brain tumors are getting bettor outcomes with ANP.

            That’s not quite it – my real point is that for every anecdote you provide about a kid who didn’t die of what is generally an indolent tumor, there is at least one, probably several anecdotes of kids with brain tumors getting piss extracts and dying either of the tumor or hypernatremia. Your anecdotes are worthless to prove that Burzynski’s piss extracts work, particularly given the fact that these kids are also often getting high-dose chemotherapy at the same time. And because Burzynski does such an awful, awful job at publishing (in timeliness, quantity and above all quality because his “studies” are nothing more than shams designed to protect his income stream), we’ll never no if his piss extracts work. Which is just how Burzynski likes it, because it means he gets to keep charging customers dying of cancer (or in many cases their terrified, grieving parents) tens of thousands of dollars for the privilege of being in a clinical trial that will never achieve anything except making Stanislaw Burzynski richer.

  3. Sawyer says:

    I’m curious if rather than receiving specific pressure to go easy on Burzinski, leadership in the FDA instead feels general pressure to reduce oversight and regulations any time there’s possibility of public anger. We’re stepping outside the realm of science and medicine here and into the realm of politics so I don’t want to speculate too much, but I think it’s fairly well known that we have Congressmen floating around that think regulation is the spawn of Satan and will soon destroy America. I can envision shrewd members of the FDA deciding it’s not worth the risk of getting their entire agency obliterated over a handful of cancer patients.

    If that is indeed the issue, there doesn’t seem much that could be done to directly change the FDA’s approach. Instead the focus should be on informing consumers and politicians on how lone-wolf quacks in medicine operate so it would be easier to build support for proper oversight in the future. Democratic government institutions are built from the ground up.

    Of course I have no clue if this “lose the battle, win the war” strategy is even happening in the FDA. Whatever the rationale this decision with Burzinski seems to be a losing strategy in the long run. They are doing a pretty good job pissing off the only people that know how to properly inform the public about medicine. Who is even going to apply for jobs with the FDA in twenty years if this is their track record?

    1. Joey says:

      Burzynski has cured diffuse brain stem gliomas in children, for 20+ years. This is unheard of. Here is just one of many peer-reviewed articles:

      http://www.burzynskiclinic.com/images/stories/Publications/994.pdf

      You “skeptics” will be exposed. ANP is superior to radiation/chemo, and they know it. Approval would disrupt a multi-billion-$ business. That’s unacceptable, apparently.

      1. WilliamLawrenceUtridge says:

        Burzynski has cured diffuse brain stem gliomas in children, for 20+ years

        Actually, He hasn’t.

        Here is just one of many peer-reviewed articles:

        http://www.burzynskiclinic.com/images/stories/Publications/994.pdf

        Sure, if you define “many” as five. That’s the number of clinical trials Burzynski has published – the rest of his publications are dish, rat and case study papers. Oh, and two of those five were phase I trials – which means he was testing toxicity, not efficacy – they say nothing about whether his piss extracts can cure cancer, merely whether it kills people. Oh, and two are “phase II preliminary reports”, so they’re also out. So basically you’re left with one study of 40 patients, of which only 17 are actually reported. Oh, and despite piss extracts being an alleged “miracle”, only one of those seventeen patients was alive after five years.

        You “skeptics” will be exposed. ANP is superior to radiation/chemo, and they know it. Approval would disrupt a multi-billion-$ business. That’s unacceptable, apparently.

        See, the whole “greed” argument doesn’t work. If ANP were superior to radiation and chemo, Big Pharma would happily produce and sell it, and make millions from it. If it cures cancer, it is chemotherapy and everyone would love to have an additional option to treat cancer. But right now, because Burzynski hasn’t actually tested it properly (in particularly against current standard of care), nobody is interested. So instead, Burzynski gets to enrich himself personally in a substantial way (let’s not forget – it’s multiple hundreds of thousands of dollars in case management fees to get piss extracts injected into you).

        Tell me again why it’s bad for Big Pharma to make hundreds of millions of dollars selling proven chemotherapy but it’s just fine for Burzynski alone to make millions of dollars selling unproven chemotherapy? Because I see it as unethical. But maybe I’m kooky.

        1. Joey says:

          “Tell me again why it’s bad for Big Pharma to make hundreds of millions of dollars selling proven chemotherapy but it’s just fine for Burzynski alone to make millions of dollars selling unproven chemotherapy? Because I see it as unethical. But maybe I’m kooky.”

          Burzynski has all the patents. That’s why. The NCI tried to re-patent them, but they know it’ll never hold up in court.

          1. MadisonMD says:

            Burzynski has all the patents.

            Don’t patents expire after 25 years or so? Burzynski’s seems to date back to 1981. So no need to mention patents at all. It’s like talking about the patent on the current patent the Commodore Amiga has such an impact on sales. No, actually, I think the Amiga was a bit more recent…

            Incidentally, I did find one B patent that should hold up in a court of law. You’ll not guess in 23 years*

            It’s antineoplaston toothpaste!

            No kidding! And the really fantastic thing about it is, well let’s let the patent abstract speak to itself:

            … [It] acts advantageously to allow the composition to remove plaque, tartar, and oral disease-causing bacteria.

            So, if you want to talk about B protecting his toothpaste patents, go nuts. But no need to pretend that ANP is under patent protection anymore.

            ————————
            *23 years, because at the current rate of progress (17 patients reported since 1998), this is the estimated time required for B. to complete phase II.

            1. Windriven says:

              “Don’t patents expire after 25 years or so?”

              Twenty years from filing date. Optionally 17 years from issue date for patents filed before the mid-90s. Either way, any patent filed after 1994 is pretty much dead.

              1. MadisonMD says:

                So, basically, anyone could make and sell ANP. Well, B still has about 9 years to make a killing on the ANP toothpaste. After that, Proctor and Gamble can get in on it, if there is a market.

                I doubt the NCI will ever try to steal a patent, despite Joey’s prattle. After all, they have the track record of giving away exclusive rights to produce drugs (e.g. Taxol).

              2. Joey says:

                Patent expiration timing doesn’t start until the drug is actually approved.

              3. WilliamLawrenceUtridge says:

                Patent expiration timing doesn’t start until the drug is actually approved.

                Funny thing – patents are necessary to protect intellectual property so you can make a return on your investment in research funding. Burzynski actually makes a substantial, a multi-million dollar profit by charging massive, massive, massive patient care fees to people as part of an ostensible* clinical trial. The thing is – Burzynski makes a lot of money, probably a lot more money, if the antineoplaston’s aren’t patented. Patents are linked to approvals, approvals require clinical trials, and clinical trials would require actually testing the piss extracts to determine if they work. And they don’t. Burzynski makes a fuckton of money running sham clinical trials, he doesn’t need or want to patent anything because that would interrupt his revenue stream.

                So try again sport.

                *Now, keep in mind of course that Burzynski’s own lawyer has said, in a book he published, that the clinical trials only exist so Burzynski can keep charging patients for his unproven treatments; the clinical trials themselves are a sham.

              4. Windriven says:

                “Patent expiration timing doesn’t start until the drug is actually approved.”

                Twenty years from filing, Slick. Doesn’t matter if it is antineoplastons or antigravity artillery.

              5. MadisonMD says:

                Patent expiration timing doesn’t start until the drug is actually approved.

                Your grasp of patent law seems as bad as your grasp of medicine.

                See 35 U.S.C. 154 Contents and term of patent; provisional rights. (a) (2):

                (2) TERM.—Subject to the payment of fees under this title, such grant shall be for a term beginning on the date on which the patent issues and ending 20 years from the date on which the application for the patent was filed in the United States or, if the application contains a specific reference to an earlier filed application or applications under section 120, 121, or 365(c) from the date on which the earliest such application was filed.

                Emphasis added to help Joey comprehend.

                Anyway, Joey. That’s ’nuff of the patent nonsense. Can you please tell us more about the toothpaste? Are there any licensees? I’m curious to know if we will see ANP-flavor Colgate soon.

            2. Joey says:

              Why did govt try to patent them in the first place?! After BRI already had patents? You are experts at dodging and weaving. You’re the Ali of medical justice, bouncing all the questions off, and focusing on your memes (that you all repeat).

              1. Chris says:

                Citation needed.

              2. Windriven says:

                What Chris means Joey, is show some hard evidence that “the government tried to patent antineoplastons. Cite the application so that we can go to USPTO and see the smoking gun.

              3. MadisonMD says:

                In addition to needing a citation, how are the events of 20+ years ago relevant to effectiveness of ANP? If someone thought B’ s anecdotes looked promising in 1990 somehow that would be proof? I have demonstrated that your statements are factually wrong. Instead of ‘me culpa’ and thank you, I get accused of dodging as you yourself sidle away from the question of effectiveness altogether and substitute fairy tales about events 25 years ago regarding long expired patents. The irony.

                Now if you want to talk about evidence of effectiveness then show what I am missing. If you are going to spin irrelevant yarns and misinformation based on half truths then I am going to keep asking about the ANP toothpaste.

              4. WilliamLawrenceUtridge says:

                I’ve never heard it claimed before that the government ever tried to patent Burzynski’s piss extracts. Can you provide proof of your assertion? Is your evidence independent of anything but Burzynski’s own word? Because that’s not good evidence.

                Also, even assuming the government tried to patent Burzynski’s piss extracts (which let’s not forget, are actually just phenylacetic acid and phenylacetyl glutamine, waste metabolites the body excretes quickly and easily in urine) how does that account for the complete failure of all of Burzynski’s clinical trials? Let’s not forget, while he can cite individual case studies (most of whom seem to recieve a significant amount of conventional care at the same thing), his actual “phase II trials” are essentially negatives – out of 40 (or 17) kids with brain cancer, only one survived longer than five years. That’s not a cure, that seems rather strong evidence that Burzynski’s piss extracts are extremely ineffective, if not outright worthless.

                So those kids parents paid hundreds of thousands of dollars, that went right into Burzynski’s pocket, to enroll in a badly-designed clinical trial, that proved little more than “kids with brain cancer tend to die”.

                Why do you defend him?

          2. WilliamLawrenceUtridge says:

            Burzynski has all the patents. That’s why. The NCI tried to re-patent them, but they know it’ll never hold up in court.

            The NCI (which, incidentally, has a pretty decent page that essentially discusses how useless the piss extracts are) can’t patent them, it’s not a private company, it doesn’t manufacture or sell chemotherapy. It’s a federally-funded research granting institute. Further, Burzynski doesn’t make money from selling his piss extracts, he makes his millions of dollars from dying children and adults via the multi-hundreds of thousands of dollars case management fees that he charges. He can’t charge for his piss extracts, since they’re classified as an exploratory drug. So he makes up for it by charging a couple thousand to look at a scan here, a couple thousand to put in an IV there, and an extra couple tens of thousands per visit because he needs a new boat.

            Incidentally, if you were in a clinical trial for Baxter “Ground Zero For Asshole Sales Shenanigans” Pharmaceuticals (any Big Pharma, Baxter was the only one I could think of with two words in the name) you would get the drug for free, the care for free, and you might even be reimbursed for being a patient.

            Tell me again how great Burzynski is.

            Incidentally, it is known what antineoplastons (aka piss extracts) are. They’re just phenylacetic acid and 3-N-phenylacetylamino piperidine 2,6-dione, which are normally no present in urine (the liver turns phenylacetic acid into phenylacetyl glutamine, which you piss out, and 3-N-phenylacetylamino piperidine 2,6-dione is made by heating and adding acid to phenylacetyl glutamine, which Burzynski then heats and neutralizes to turn it back into phenylacetyl glutamine). We know what the piss extracts are, they’re a normal part of metabolism, it’s already found in your body, and it’s quickly processed back into a substance that you just piss out.

            Burzynski lies to people, and you’re falling for those lies. How do you feel about that?

        2. Joey says:

          5 is more than anyone else.

          1. WilliamLawrenceUtridge says:

            Yeah, but those five were a waste of money, a waste of time, cost the patients a huge amount of money and time, most of whom didn’t survive, Burzynski’s bragging to the contrary, and aren’t based on anything resembling prior probability. Oh, and were accompanied by high-dose chemotherapy as well. Did you know that? Burzynski likes to throw in some good ol’ fashion chemo along with his piss extracts, adding yet more pollution to the information cesspool – because you never know if the piss extracts did anything, or if it was the chemo that deserves all the credit.

            Also, did you not see how incredibly those studies undercut Burzynski’s claims? 40 people enrolled, only 17 reported (presumably the best cases) and of those 17, 16 were dead after five years! Does that sound like a fucking cancer cure to you? That sounds like “dying of cancer” to me, but maybe that’s because I understand 16 dead kids is considerably more than 1 live one. And if this is the same group of subjects, the whole 40, it’s even worse – only one out of forty survived, a survival rate of 2.5%! And you support this asshole as some kind of hero of cancer treatment? Why? Because if you ask me – the reason Big Pharma isn’t interested in Burzynski’s piss extracts is because they basically don’t work – based on his own numbers and publications!

            No wonder he waited twenty years before he published, it gave him so much more time to accumulate some hooker and blow money.

            I mean seriously, how can you defend him when he’s so patently dishonest? He lies to dying children and their desperate, sobbing parents, then shafts them with a bill for hundreds of thousands of dollars after their kid dies! And you’re willing to say even one nice thing about him?

            Why?

  4. Rich Remmy says:

    Burzynski’s treatments are expensive and they work. Traditional medicine’s treatments are expensive but do not work. If someone in your family had a terminal brain tumor and traditional medicine’s treatments did not work, wouldn’t you do everything in your power to help them live?

    1. Windriven says:

      “Burzynski’s treatments are expensive and they work. ”

      So where’s the objective evidence to back your claim? Is it a super duper deep dark secret?

      1. Joey says:

        Here’s a randomized phase II study from Japan that shows antineoplastons work:

        http://www.burzynskiclinic.com/images/stories/Publications/8774.pdf

        1. Windriven says:

          Joey, you need to ankle on over to Annals of Oncology and read the article that you linked. It shows pretty equivocal results (that isn’t a good thing).

          1. Joey says:

            Wrong link, sorry. Here’s the right one. Study done in Japan:

            http://www.burzynskiclinic.com/images/stories/Publications/968.pdf

            1. WilliamLawrenceUtridge says:

              That’s not a study, that’s a case report.

              How many people used the same approach and died of cancer?

              Also, he got radiation therapy and surgical resection – so what cured him, the piss extracts or the surgery (which is curative for many solid tumors) or the radiation therapy?

              Also, if I’m reading it right – he got surgery for his cancer, then he got piss extracts, then he got cancer again, then he got radiation therapy (or three rounds of microwave ablation, if that’s not the same thing), then he didn’t have cancer. So…if piss extracts are so great, why did he get two metastases followed by getting the tumors nuked? If piss extracts are so great, shouldn’t they have prevented the metastases?

              Sounds like your piss extracts suck.

              1. Joey says:

                “Piss extract”. You know very well he’s been making them synthetically since the early 90′s.

                Meanwhile Premarin, widely sold, is made from horse urine. You’re toting out all the typical “skeptic” (aka shill) lines.

              2. AdamG says:

                Sooo you have no response to the actual substance of the comment? Remember, when you claimed that you had “a randomized phase II study from Japan that shows antineoplastons work” but only presented a case study?

              3. WilliamLawrenceUtridge says:

                Yeah, I use “piss extracts” mostly to mock the origins of the compounds. Seeing as we know exactly what they are and how they got into the piss, I could switch to another term, but I consider the distasteful connotations to be apt. But at least I’m not saying “prison piss extracts”, right?

                Meanwhile Premarin, widely sold, is made from horse urine. You’re toting out all the typical “skeptic” (aka shill) lines.

                You know the difference? Premarin works (and is cleaved upon entering the GI tract into an estrogen that exactly mimics a human form – unlike Burzynski’s piss extracts which are actually a waste metabolite he’s re-introducing to the body along with a whole lot of chemotherapy and enough salt to put you in a coma).

              4. Harriet Hall says:

                It doesn’t make any difference whether a chemical compound is made in a plant, a horse, a human bladder, or a lab; but just for the record, I think Premarin is no longer made from horse urine. They say it is made from “natural sources” (unspecified) blended to approximate the mixture of hormones in a horse’s urine.

    2. KayMarie says:

      I think you may have framed that question incorrectly, at least for me.

      If you had the chance to get your loved one into a science-based research program where all of their medical costs of evaluating and treating them according the protocol as well as the costs of any complications were paid for completely by the researcher’s grants and they could show you ahead of time the data that indicates how well it is expected to work so that they may have a better chance to live or had the chance to put them into a speculative not so science based research program where you and your family will have to beg on the internet to afford the costs and any complications will be paid for by you or your insurance and where you have just the promises of the promoter of the approach and whomever writes their anecdotes/ad copy to review to see if it might work to give your loved one a chance of surviving, which would you choose?

      Of course the other option is to go with the standard protocol with the known survival rates that your insurance will help cover (or the charity arm of the hospital will cover) vs paying for a promise completely out of your own pocket.

      While I understand the do anything to save them, at least maybe we could at least try the approach a few of the Chinese TM/energy woo people I take exercises classes from tend to have. Do EVERYTHING get better faster, including the standard science-based protocols recommended by your physicians (so do the healing diet and the healing exercise and the mediation and the energy healing and the surgery and the chemo and the whatever else your doctor tells you to do). Probably will get them in trouble if any of the other CAM folks for not being true enough believers to proclaim that one must only do the woo. I know one practitioner who will actually drop you as a customer if you stop seeing your oncologist. How weird is that?

      My apologies for the excessive sentence length. Sometimes my English teacher’s love of Faulkner is all too apparent.

    3. Travis says:

      I was unaware that they work.
      Source?

    4. R Miller says:

      “Burzynski’s treatments are expensive and they work.”

      Well, you’re half right.

      “Traditional medicine’s treatments are expensive but do not work.”

      Well, you’re half right.

      Re-arrange some words and you might have a whole right.

      “If someone in your family had a terminal brain tumor and traditional medicine’s treatments did not work, wouldn’t you do everything in your power to help them live?”

      Yes, within reason. However, I would certainly not empty their or my bank account and jeopardize my family’s well-being because someone offers me mere hope and a suggestion of a treatment with no evidence of efficacy.

      Regardless, this is a perspective that you and many in our cultural possess, but understand it is not univerisal; the heroic idea that life must be preserved at any and all costs with reckless abandon, and that pure emotion must drive every decision beyond a certain point does not apply to all philosophies of medicine and health. Death is a reality, and it’s more productive to spend time cherishing the last bit of a life with family than burning the candle shopping around for quack after quack after quack in the hopes that *this time* it really will be the promisd supernatural prophet of God-granted oncological knowledge that no physician can access, and not yet another guy with a grin and a book to sell.

      1. Joey says:

        If you wanted to make money from a movie about pharma, you make one about Gleevac (sp?) Tell the story of the genius who invented it, and how much of an FDA-approved success it is.

        Don’t tell the other story if you want to make money. Eric Merola (dir of Burzinski: The Movie) is currently being audited by the IRS:

        https://www.youtube.com/watch?v=zfZW8YVya0c

        1. WilliamLawrenceUtridge says:

          The funny thing about Gleevec is – it works really, really well for one type of cancer. Like, phenomenally well. Like, cures 95% of patients with that single type of cancer with a very specific point mutation as an etiology (I think the mechanism is Gleevec binds to the very specific enzyme produced by the cancer-causing mutation). Give someone with Ph+CML and they’ll get better with Gleevec alone. Meanwhile your best bit of evidence appears to be a single case report of a guy who got three different kinds of cancer treatment. Can’t you see the difference?

          Don’t tell the other story if you want to make money. Eric Merola (dir of Burzinski: The Movie) is currently being audited by the IRS:

          Good, I hope he gets bankrupted and sent to prison.

  5. Windriven says:

    “I’m curious if rather than receiving specific pressure to go easy on Burzinski, leadership in the FDA instead feels general pressure to reduce oversight and regulations any time there’s possibility of public anger.”

    I wrote to Senator Patty Murray (D WA) and her legislative affairs aide for health policy regarding Burzinsky and followed that letter (Fedexed to her WA offices) with several phone calls to the legislative aide. I have received not so much as an ‘eff you’ form letter in return. If she runs again in 2016 I’ll make it an issue in the Seattle media framed as her protecting a dangerous quack.

  6. Vince says:

    I’m curious about your review of the Dr. Hideaki Tsuda of Kurume Medical University Phase I, II, and III studies where Antineoplastons have been independently tested for 27 years?

    1. Windriven says:

      Have some citations there Sparky? I checked Pubmed and found lots of lab work but I only a few Phase I human trials with very small study populations.

    2. WilliamLawrenceUtridge says:

      They may have been tested for 27, but the results were not published for essentially that entire period, and it turns out it’s mostly just petri dish studies. In other words – more of the same, scientifically useless trials to justify and gloss over the incredible money-maker that ANPs are for Burzynski and his asshole shills. But here are some links:

      http://www.sciencebasedmedicine.org/stanislaw-burzynskis-cancer-success-stories/

      http://www.sciencebasedmedicine.org/burzynski-cancer-is-a-serious-business-part-2-like-the-first-burzynski-movie-only-more-so/

      http://www.sciencebasedmedicine.org/stanislaw-burzynski-propaganda-versus-news/

      http://www.sciencebasedmedicine.org/stanislaw-burzynski-trying-to-relive-his-success-beating-the-rap-in-the-1990s/

      And some off-site links:
      http://scienceblogs.com/insolence/2013/08/12/antineoplaston-fails-publication/

      http://twentyfirstfloormirror.wordpress.com/2013/02/17/burzynski-the-japanese-research/

      1. Joey says:

        You honestly don’t think this is worthy of phase 3 trials, which have been continually disrupted by the FDA and the NCI since at least 1993?

        http://www.burzynskiclinic.com/images/stories/Publications/968.pdf

        I repeat. Pediatric diffuse brain stem gliomas cured (different study).

        1. MadisonMD says:

          Excuse me, Joey. It is hard to follow your scattered thoughts. Your link seems to be an N=1 case study on colorectal cancer. Why do you think that is relevant to glioma?

          Also, don’t you think it would be worth publishing the phase II study on DIPG prior to undertaking phase III? Didn’t B start the phase II study over 15 years ago? Actually many many phase II glioma trials? Did he complete any of the studies yet? I’d like to see the publication complete results of the phase 2 DIPG study before venturing an opinion on whether a phase 3 is indicated for this disease. I’d also like to know the outcomes of the >7000 patients treated over the past 30 years, not just the case reports for one or two cherrypicked from amongst thousands by B.

          Also, how did FDA disrupt a phase III trial? Wasn’t this the agency that forced B to actually open phase II trials in 1998? Without that agreement, wasn’t B’s plan simply to continue selling the drug to thousands of patients off trial and without clinical evidence of efficacy? How, in your mind, is that disrupting a phase III, since it doesn’t seem that B had any plan to undertake any such study?

          Finally, what do you and/or B propose for the control arm of the phase III trial? Just wondering.

          1. Joey says:

            “Didn’t B start the phase II study over 15 years ago? Actually many many phase II glioma trials?”

            No, because the FDA is playing interference. 5 grand juries, zero indictments. Unending harassment.

            1. AdamG says:

              How exactly did any of that, if true, prevent B from publishing his results from the last 15 years?

            2. WilliamLawrenceUtridge says:

              No, because the FDA is playing interference. 5 grand juries, zero indictments. Unending harassment.

              What you mean the FDA keeps getting harassed by politicians caving to sobbing children and parents?

              And actually – that’s not quite true. The FDA shut down the clinic and demanded changes and improvements. Burzynski is a bad-faith player, he doesn’t care about the FDA or their recommendations. He’s all about the Benjamins. So he’s stalling, he’s sliming up to congresspeople, he’s doing whatever he can to keep drawing it out and delaying actually having to fairly test his piss extracts (with high-dose chemotherapy, don’t forget about that). Because if he actually tested them in a good-faith manner, there would be evidence, and if the evidence is bad, he’d have a harder time charging patients hundreds of thousands of dollars in sweet, sweet case management fees that have made him so very, very rich. He’s been stringing the FDA and his patients along for decades now, and even found a way around the current restrictions by getting a third-party doctor to administer the piss extracts (oh, and then getting that third-party to shake down the families for the tens of thousands of dollars in case management fees that go straight back to the Burzynski clinic).

              Tell me again about how greedy Big Pharma is, and how Burzynski is just out to cure cancer?

        2. WilliamLawrenceUtridge says:

          You honestly don’t think this is worthy of phase 3 trials, which have been continually disrupted by the FDA and the NCI since at least 1993?

          No, I don’t. Also, are you a moron? That’s a case report for liver cancer, not brainstem glioma. And the FDA would love it if Burzynski would actually test his shitty piss extracts, but he doesn’t. He pretends to, but as his own laywer says – they only set up those bogus clinical trials because it was a way to keep making money. It’s not about curing cancer, it’s about Burzynski being a greedy and unethical shithead.

          Also, any reason why in his study of pediatric brain cancers, he only reported on 17 out of 40 patients? And only one of those 17 was alive after five years?

          1. MadisonMD says:

            That B. paper is pretty nifty, WLU. It turns out that if you look at a different MRI cross-section, the tumor totally disappears! (compare Figure 3 top, illustrating tumor with slice through eyeballs versus Figure 3, bottom with slice with no eyes in them). If he had thought to use this technique on every patient, his outcomes would have been even better. His complete response is no better, because he declared post-hoc that he would define it by metabolic imaging alone. This is not a standard definition, and you can clearly see residual tumor in Figure 2, bottom (less prominent because there is less vasogenic edema that appears as white on T2 MRI image– this improvement can be achieved with steroid pills).

          2. MadisonMD says:

            And only one of those 17 was alive after five years?

            Isn’t a 15-year survivor good enough to show ANP works!?

            Well, only if that would not happen without ANP. The Burzynski paper says that that patient had a pilocytic astrocytoma (see last paragraph in discussion in WLU’s link.) The 5-year survival rate for unresectable pilocytic astrocytoma is 92%.

            So, one 15-year survivor with pilocytic astrocytoma, a benign indolent tumor, means basically nothing.

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