Over the last couple of weeks, I’ve been spending a lot of time (and, characteristically, verbiage) analyzing the phenomenon known as Dr. Stanislaw Burzynski, his “cancer cure” known as antineoplastons, and his incompetent version of “personalized gene-targeted cancer therapy.” In this third and final part, I want to come back to antineoplastons, because it has been pointed out to me that there is an aspect of this story that has received little attention. One of my readers in particular has helped enormously. I wish I could credit this person by name to express my gratitude, but, for reasons I fully understand, I am not permitted to. However, this person’s input was essential, and I’ve even appropriated (with permission, of course) a bit of text here and there e-mail exchanges to “integrate” into this post. Putting this together with information in my previous posts, I think we can come to some conclusions about what it is that Dr. Burzynski is really doing.

Antineoplastons = sodium phenylbutyrate

In the first part of this series, I pointed out that back in the 1970s Dr. Burzynski claimed to have discovered cancer-fighting substances in human urine, which he dubbed “antineoplastons.” However, I was pretty vague about just what these substances were, other than to point out that they were modified amino acids and that since 1980 Dr. Burzynski has been synthesizing them in a chemistry lab rather than isolating them from urine, as he had done before. This vagueness came simply from my interest in moving straight to looking at Burzynski’s claims rather than what these substances were. In retrospect, that might have been a mistake. The reason is that understanding what two of Burzynski’s antineoplastons are is critical to understanding what he is doing with them and why he might occasionally appear to be observing an antitumor response.

So what are antineoplastons? According to Quackwatch:

By 1985, Burzynski said he was using eight antineoplastons to treat cancer patients. The first five, which were fractions from human urine, he called A-1 through A-5. From A-2 he made A-10, which was insoluble 3-N-phenylacetylamino piperidine 2,6-dione. He said A-10 was the anticancer peptide common to all his urine fractions. He then treated A-10 with alkali, which yielded a soluble product he named AS-2.5. Further treatment of AS-2.5 with alkali yielded a product he called AS-2.1. Burzynski is currently treating patients with what he calls “AS-2.1” and “A-10.”

In reality, AS-2.1 is phenylacetic acid (PA), a potentially toxic substance produced during normal metabolism. PA is detoxified in the liver to phenylacetyl glutamine (PAG), which is excreted in the urine. When urine is heated after adding acid, the PAG loses water and becomes 3-N-phenylacetylamino piperidine 2,6-dione (PAPD), which is insoluble. Normally there is no PAPD in human urine.

What Burzynski calls “A-10” is really PAPD treated with alkali to make it soluble. But doing this does not create a soluble form of A-10. It simply reinserts water into the molecule and regenerates the PAG (Burzynski’s AS-2.5). Further treatment of this with alkali breaks it down into a mixture of PA and PAG. Thus Burzynski’s “AS-2.1” is nothing but a mixture of the naturally occurring substances PA and PAG.

If you peruse ClinicalTrials.gov for Burzynski’s current clinical trials, you’ll find that pretty much all of them use antineoplastons AS-2.1 and A-10; i.e., phenylacetic acid (PA) and phenyl acetyl glutamine (PAG). But wait! you might say. Why does this matter? PA and PAG are not sodium phenylbutyrate! True enough. However, right there, in one of the e-mails from Renée Trimble, PR flack from the Burzynski Clinic. I had asked her in an e-mail how the Burzynski Clinic did its “personalized gene-targeted cancer therapy,” and she responded:

The combination contains drugs which have synergistic activity which permits reduction of doses. The combination proven ineffective by prior data, is not used. Antineoplastons and their prodrug, phenyl butyrate, are important ingredients of the combination because they cover the spectrum of approximately 100 genes. Two articles in peer reviewed journals have been published by our group recently and are attached.

I’ve discussed the fallacy of the “100 to 200 genes” before in parts I and II of this series. However, what caught my eye was the statement that phenylbutyrate is a prodrug for these antineoplastons. For those who are not familiar with basic pharmacology, a prodrug is a drug that is metabolized into something else, and it is that something else that is the actual active molecule that produces a therapeutic effect. In other words, a prodrug must undergo a chemical conversion in the body before it is active. It is also interesting to note that the complaint against Dr. Burzynski from the Texas Medical Board also mentions phenylbutyrate:

Respondent prescribed a combination of five immunotherapy agents – phenylbutyrate, erlotinib, dasatinib, vorinostat, and sorafenib-which are not approved by the Food and Drug Administration (“FDA”) for the treatment of breast cancer, and which do not meet the FDA’s regulations for the use of off-label drugs in breast cancer therapy.

One of the papers that Ms. Trimble sent to me also features sodium phenylbutyrate. It’s a paper testing phenylbutyrate on esthesioneuroblastoma and nonsmall cell lung cancer and explains its rationale thusly:

Sodium phenylbutyrate (PB) is an FDA-approved drug for urea cycle disorders, and it is also indicated for the treatment of primary and recurrent glioma and acute promyelocytic leukemia [5,6]. PB is partially metabolized in the human body into phenylacetate (PN) [7]. Both PB and PN have been extensively studied for their effect on neuroblastoma [8]. Integration of PB into ne- uroblastoma therapy has been highly recommended [9]. Previous studies reveal that PB has cytotoxic effect on human neuroblastoma, and that it can be combined with cisplatin in novel chemotherapy regimens [8]. PB is a histone deacetylase (HDAC) inhibitor. New publications recommend the use of such FDA-approved drugs for the treatment of neuroblastoma [10,11].

And there you have it. Burzynski’s antineoplastons are nothing more than the byproducts of the body’s metabolism of a known drug, sodium phenylbutyrate. Yes, it does target genes, but not in the way commonly meant when we refer to “targeted therapy,” which normally means targeting one or a handful of related genes. Rather, it targets lots of genes, making it, in essence, no more “specific” than chemotherapy.

Let’s explore the implications of this little-publicized bit of information that Burzynski doesn’t exactly advertise.

An orphan drug

Sodium phenylbutyrate, it turns out, is a drug that was originally marketed as a treatment for urea cycle disorders. It goes under the trade names Buphenyl (Ucyclyd Pharma, Hunt Valley, USA Ammonaps (Swedish Orphan International). As you might gather from the name of the Swedish company that makes it, it is an orphan drug. What that means is that it is a drug that was developed to treat a rare medical condition. Because so few people suffer from such conditions (they are, after all, rare), there is little profit to be made in selling such drugs, meaning that for a pharmaceutical company it doesn’t make economic sense to go through the many hundreds of millions of dollars that it requires to obtain FDA approval for such drugs for such indications. That doesn’t even take into account that it might be difficult to accrue enough patients to do a phase III clinical trial to demonstrate efficacy and safety. Both the U.S. and the European Union have laws to facilitate the development and marketing of orphan drugs.

It turns out that sodium phenylbutyrate potentially has several indications. There is, of course, the aforementioned treatment of urea cycle disorders, which are inborn errors of metabolism. However, that’s not the only indication, as can be deduced by searching PubMed and ClinicalTrials.gov for the search term “phenylbutyrate.” What you’ll find are over 1,300 articles on PubMed and 35 clinical trials on ClinicalTrials.gov. These clinical trials include trials testing phenylbutyrate in amyotropic lateral sclerosis (i.e., Lou Gehrig’s disease), spinal muscular atrophy type I, spinocerebellar ataxia type 3, and, of course urea cycle disorders.

Doing a search for “phenylbutyrate AND cancer” on PubMed and ClinicalTrials.gov is also informative. There are currently several trials listed on ClinicalTrials.gov, most of them completed. Trials of sodium phenylbutyrate that do not list Dr. Burzynski as an investigator including trials of lung cancer, prostate cancer, metastatic solid tumors unresponsive to chemotherapy. Most of these trials are either completed or terminated, and some of them even have published results. For example, here are the results from a phase I clinical trial in glioma, conducted by the New Approaches to Brain Tumor Therapy (NABTT) CNS Consortium, which is funded by the National Cancer Institute (NCI), and published in Neuro-Oncology in 2005. Sadly, they are not promising, even for a phase I trial, which, as you might recall, is the preliminary “first in humans” sort of trial designed to test for safety and maximum tolerated dose, not efficacy, except as a secondary endpoint:

Of the 23 patients enrolled, 19 could be evaluated for tumor response. One CR and no PRs were noted, providing an overall response rate of 5% (95% confidence interval, 0-26%). Five patients (four GBM, one AA) demonstrated stable disease (SD) as the best response and a median time to progression of 5.4 months (range, 1.9-5.7 months). Thirteen patients (11 GBM, 2 AA) demonstrated progressive disease without a period of SD, and they all received fewer than four cycles of PB therapy. Fifteen patients were on enzyme-inducing anti-epileptic drugs. Of note, four of the six patients with CR or SD were on enzyme-inducing antiepileptic drugs. Nineteen of the 20 patients who could be evaluated for survival have died. The total number of person-years of follow-up was 18.2, and the surviving patient has been followed for more than five years. Median survival time was 5.4 months.

There are other trials as well, a few of which I will briefly mention:

  1. The Novel Deacetylase Inhibitor AR-42 Demonstrates Pre-Clinical Activity in B-Cell Malignancies In Vitro and In Vivo. (Preclinical study.) This study used a modified version of sodium phenylbutyrate (AR-42, also known as OSU-HDAC42) in preclinical models of B-cell malignancies including cell culture and SCID mice to show that AR-42 showed promise in this class of malignancies.
  2. A phase I dose-finding study of 5-azacytidine in combination with sodium phenylbutyrate in patients with refractory solid tumors.. (Phase I trial.) Conclusion: “”The combination of 5-AC and phenylbutyrate across three dose schedules was generally well tolerated and safe, yet lacked any real evidence for clinical benefit.”
  3. Combination of cytotoxic-differentiation therapy with 5-fluorouracil and phenylbutyrate in patients with advanced colorectal cancer. (Phase I trial) Conclusion: “Weekly infusions of FUra followed by PB were fairly well tolerated with disease stabilization in 3/4 (75%) of patients. This is the first report to demonstrate the feasibility of combining a cytotoxic agent with a HDACi as a cancer treatment.”
  4. Phase I dose escalation clinical trial of phenylbutyrate sodium administered twice daily to patients with advanced solid tumors. (Phase I trial.) Conclusion: “Administration of PBA in a twice-daily infusion schedule is safe. The maximum tolerated dose is 300 mg/kg/day. Study designs with more convenient treatment schedules and specific molecular correlates may help to further delineate the mechanism of action of this compound. Future studies evaluating PBA’s ability to induce histone acetylation and cell differentiation alone or in combination with other anti-neoplastics are recommended.”
  5. Complete response of a recurrent, multicentric malignant glioma in a patient treated with phenylbutyrate. (Case report.) After treatment of an anaplastic astrocytoma of the frontal lobe with radiation therapy and Procarbazine-CCNU-Vincristine, the tumor recurred as multiple lesions in this patient, who was started on sodium phenylbutyrate. This patient’s tumors regressed over nine months until they disappeared. Her complete response lasted over 20 months, which continued after discontinuation of sodium phenylbutyrate. The authors concluded: “This is the first report, to our knowledge, of a complete and durable response of a malignant glioma to phenylbutyrate. These clinical findings are consistent with the antiglioma effects of phenylbutyrate noted by Engelhard et al. [4], who described antiproliferative effects, inhibition of urokinase and c-myc expression, as well as impairment of cell migration and invasiveness, and induction of differentiation.”

If you look over the PubMed references, it turns out that researchers first examined phenylacetate as a potential treatment for cancer as far back as 1959, and there are some clinical trials still listed on ClinicalTrials.gov testing phenylacetate against various cancers, although there is understandably some overlap with the trials testing sodium phenylbutyrate, most likely because somewhere in the trial it’s mentioned that phenylacetate is a metabolite of phenylbutyrate. This trial, however, only used phenylacetate in children with recurrent or progressive brain tumors. It’s been completed, but unfortunately no results have yet been reported.

But why should sodium phenylbutyrate be suspected to be a potential anticancer drug? It turns out that it inhibits an enzyme known as histone deacetylase. Histones, the molecular biology geeks out there will know, are proteins around which DNA is wrapped in such a way that a “scaffolding” is formed. The whole complex of DNA and its associated proteins is called chromatin. When DNA is wrapped around its histones, it is usually transcriptionally inactive or silent; i.e., it’s not transcribed into RNA and translated into protein. Histone acetylases and deacetylases modify histones to make them either more or less “sticky,” respectively, to DNA. In other words, chromatin that is more acetylated is generally more active in making its gene products and chromatin that is less acetylated is less active or even silent. Indeed, histone acetylation and deacetylation are major epigenetic mechanisms of controlling gene activity. It turns out that histone deacetylase (HDAC) inhibitors (HDIs) can have anticancer effects by inducing the accumulation of hyperacetylated chromatin, thus shutting down certain genes, and inhibiting the acetylation of other proteins that regulate gene expression. Some of the mechanisms proposed include inhibition of a protein known as p21WAF1/CIP1, which regulates p53, among others. No doubt this is the sort of rationale that leads Dr. Burzynski to tout his claim that his antineoplastons shut down “100 to 200 genes.” Currently, besides sodium phenylbutyrate, two other HDAC inhibitors are FDA-approved: Vorinostat and Romidepsin, both for cutaneous T-cell lymphoma. Several others are in the pipeline, from phase I to phase III clinical trials.

One interesting take on phenylbutyrate as a cancer treatment can be found at, of all places, the website of an insurance company. Basically, Aetna has a policy regarding antineoplastons and phenylbutyrate which is worth considering. Basically, Aetna states that it considers antineoplastons and associated medical services to be “experimental and investigational because there is insufficient evidence published in the peer-reviewed medical literature validating the effectiveness of antineoplaston therapy for any indication.” However, in contrast, Aetna considers sodium phenylbutyrate to be:

  • “…medically necessary for the treatment of acute promyelocytic leukemia and malignant glioma.”
  • “…experimental and investigational for the treatment of breast cancer, prostate cancer or cancers other than acute promyelocytic leukemia and malignant glioma.”
  • “…experimental and investigational for the treatment of amyotrophic lateral sclerosis, beta-thalassemia, insulin resistance and beta-cell dysfunction, maple syrup urine disease, sickle cell anemia, spinal muscular atrophy, and for all other indications.”

Insurance companies tend to be pretty conservative in deciding what therapies to cover; so the fact that Aetna will cover sodium phenylbutyrate for some indications, including at least one cancer, puts a rather fascinating spin on the issue that will become important later in this discussion.

A blind squirrel

At this point, the reader might be tempted to ask whether Orac has gone off the deep end and become a Burzynski apologist. He might be wondering whether I’m invoking a couple of old and corny sayings about how even a blind squirrel finds an acorn every once in a while or how a stopped clock is correct twice a day. Such a reader has only to go back to part II in my series to disabuse himself of that notion, given how I pointed out that it’s not the concept of “personalized gene-targeted therapy” to which I object. It’s how Burzynski does it and how he corrupts the very concept through his “everything but the kitchen sink” approach to throwing “targeted” therapies at cancer patients willy-nilly without a systematic rationale for picking them or, it seems, any concern for potential adverse reactions due to combining drugs that have not been tested adequately in combination.

My point is that the Burzynski saga is more complicated than the simple narrative that a lot of skeptics, even skeptics I admire greatly, have imposed on it, which appears to be that Burzynski is a quack; antineoplastons are “toxic byproducts” and don’t work; and that’s that. Quack Dr. Burzynski might be, but unfortunately his possible quackery has intersected and contaminated real science. So let’s put sodium phenylbutyrate and antineoplastons in context. While it is true that, thus far, there is little evidence that sodium phenylbutyrate is effective in most cancers (some brain tumors like gliomas might be an exception), it’s also not correct from a scientific and skeptical standpoint to dismiss it, and thus antineoplastons, out of hand. There is enough evidence out there (the complete response in a glioma patient, for instance) to suggest that there might–just might–be something to this approach. However, is it a magic bullet?

Of course not!

And that’s where Dr. Burzynski goes astray. Not only is he “doing it wrong” but he’s “selling it wrong” as well, charging huge sums of money for his special cocktail of targeted therapies and sodium phenylbutyrate under the guise of clinical trials and forcing patients to bear the cost, while enticing them to bear that cost by making extravagant promises and wrapping his selling of antineoplastons up as part of “personalized gene-targeted therapy.” He’s also prescribing huge doses of antineoplastons (up to 25 g/kg/d for A10 and 80 mg/kg/d for AS-2.1, as we have seen). both of these are so far above the maximal tolerated dose of 300 mg/kg/d determined in the phase I trial I cited above as to be terrifying. True, in all fairness, antineoplastons A-10 and AS-2.1 are not sodium phenylbutyrate, making comparisons of MTDs perilous, but they are metabolites of this drug and their molecular weights are not so different that using nearly 100-fold more than the MTD seems advisable or safe. It’s also true that Dr. Burzynski often claims that very high doses are needed to be effective. Indeed, a key part of the collapse of his NCI trial in the 1990s was due to Dr. Burzynski’s unhappiness with the dosing schedule and his belief that it should be higher, while the NCI was concerned about the risk of serious side effects. Even if he were correct, which he might have been, a drug that requires doses so high that it causes hypernatremia due to the sodium in its salt is rarely a particularly useful drug. Even worse, switching to phenylbutyrate as drug that “generates neoplastons in the blood,” as Burzynski has called it, isn’t a particularly good strategy. The phase I trial I mentioned above that studied the pharmacokinetics of phenylbutyrate indicates that it’s not a good source of phenylacetate, as the authors concluded:

In summary, phenylbutyrate exhibits saturable, nonlinear pharmacokinetics after intravenous administration and achieves peak concentrations in the range of in vitro tumor activity. Concentrations of the active, intermediate metabolite (phenylacetate) were low in this study and did not achieve levels at which saturation occurs. The conversion of phenylbutyrate to phenylacetate was high (80%), but the rapid, subsequent conversation to phenylacetylglutamine resulted in serum levels of phenylacetate that were much lower than those seen when the drug is given intravenously. We conclude that phenylbutyrate should not be considered a clinically useful prodrug of phenylacetate and that phenylbutyrate and phenylacetate should be pursued as independent antineoplastic agents.

In other words, Dr. Burzynski’s rationale for using phenylbutyrate, namely that it’s a prodrug for antineoplastons, while technically true, is deceptive. The reason is that pharmacokinetic studies suggest that phenylbutyrate does not generate clinically useful concentrations of phenylacetate in the blood. Also, as we have seen, the NCI’s concerns were not without foundation, particularly its concern about the risk of severe hypernatremia, which several of Dr. Burzynski’s patients have experienced. Also in all fairness, in the publications of two trials of sodium phenylbutyrate that Ms. Trimble sent me, Dr. Burzynski used 200 mg/kg/d or 6 g/d, which in a typical 70 kg adult is around 85 mg/kg/d, both of which are below the maximum tolerated dose determined in the study I mentioned above. Also, given that they are below the MTD, they are also almost certainly at a dose that fails to generate significant concentrations of “antineoplastons” in the blood. Worse, Dr. Burzynski is also adding sodium phenylbutyrate to a whole bunch of other drugs whose interactions with it have not been studied.

As much as I hate to admit it, there is a modicum of science here. It’s just that, in Dr. Burzysnki’s hands, unfortunately it’s incredibly sloppy science, Trials are not designed so that they can ever answer the question of whether the real drug, namely sodium phenylbutyrate, is effective, either alone in combination, against cancer, and, if it is, against which cancers. Rather, they appear custom-designed so that Dr. Burzynski can keep administering antineoplastons (which, remember, are nothing more than the metabolic breakdown products of sodium phenylbutyrate) to patients. It’s also incredibly unethical science in that Dr. Burzynski is requiring patients to pay huge amounts of money out-of-pocket for unvalidated combinations of targeted therapies thrown together with (these days, at least) sodium phenylbutyrate and sold as “personalized gene-targeted cancer therapy.” As for his clinical trials, he has been warned by the FDA about lax Institutional Review Board procedures that fail to protect human subjects, fail to guarantee adequate informed consent, do not adequately monitor studies with ongoing reviews, and fail to report conflicts of interest of IRB members. In other words, not only does Dr. Burzynski do “personalized targeted therapy” badly; he does clinical trials badly as well.

So what exactly is Burzynski up to? Why, if sodium phenylbutyrate is available from not one, but two pharmaceutical companies as an orphan drug and the NCI and many other researchers are investigating it (and were investigating phenylacetate before that), would Dr. Burzynski have such an interest in portraying himself as a “brave maverick doctor“? Why does he still have such an intense interest in attracting people to his clinic using the “antineoplaston” brand name, now coupled with his new brand, “personalized gene-targeted cancer therapy”? Why does he sell so much chemotherapy–yes, chemotherapy, as I have shown–along with cocktails of expensive targeted therapies which, although less toxic than cytotoxic chemotherapy, still carry risks, not to mention cost a lot of money? Why do his supporters (and, let’s be honest, Dr. Burzynski himself) portray his therapy as “nontoxic” and “not chemotherapy,” even implying that it is not a product of big pharma, even though we have just seen that it is?

Looking at the claims of the Texas Medical Board against Dr. Burzynski, which include overprescribing without benefit and running his own pharmacy, and the costs of treatment at the Burzynski Clinic, which are freely discussed on patient blogs such as Supatra’s Fairy Fund and Cancer is a Bad ASS Bitch But We Are Badder (not to mention the claims of Wayne Merritt that Dr. Burzysnski is massively overcharging) that I discussed last week, I start to get the impression that what we are dealing with is not a misunderstood scientist or a “brave maverick doctor, but something more slippery, someone who skirts the fuzzy line between bad science and outright quackery for profit.

This starts to become very important when you consider what price people will pay for hope. As far as I can see and based on what I’ve found out, Dr. Burzynski’s antineoplastons appear to be nothing more than a different way of administering sodium phenylbutyrate. The difference is that they are administered at very high doses, and added to (in what appears to be most patients at the Burzynski Clinic these days) a luxury cocktail of chemotherapy and eye-wateringly expensive targeted cancer therapies prescribed off-label using a “Targeted Cancer Therapy for Dummies”-level interpretation of a genomic assessment of the patient’s tumor the company Caris, which is still also at an experimental stage.

Here’s where it gets even more interesting.

As I mentioned above, the insurance company Aetna has a policy outlining under what conditions and for what diseases it will cover sodium phenylbutyrate therapy. In that policy, it also states:

Since sodium phenylbutyrate has been approved by the FDA for treatment of other indications, physicians can prescribe it for patients without any danger of legal sanctions or need for compassionate use exemptions. However, there is no adequate evidence in the peer-reviewed published medical literature demonstrating that the use of sodium phenylbutyrate improves the clinical outcomes of patients with cancers of the prostate, breast, or cancers other than acute promyelocytic leukemia and malignant glioma. Current evidence is limited to in vitro and in vivo studies and Phase I studies. Prospective Phase III clinical outcome studies are necessary to determine the clinical effectiveness of sodium phenylbutyrate for cancer.

Note this phrase: “…physicians can prescribe it for patients without any danger of legal sanctions or need for compassionate use exemptions.”

Here’s what the Memorial Sloan Kettering Cancer Center has to say about it, with full links to many of the studies and a handy rundown of toxicology data (including the fact that each 500 mg tablet of sodium phenylbutyrate contains approximately 62 mg sodium – which is why, at the doses Burzynski must be using, is a massive risk of side effects including hypernaetraemia and death). Note this important phrase: “Patients are prescribed phenylbutyrate off-label to treat cancer.”

So the main thing that Burzynski stands to gain from continuing the way he is continuing is uninformed patients who have (or, like some patients who manage to raise a lot of money through medical fund raisers, can get) lots of money. These are patients who are already prone to be attracted to woo and who have come to think from reading various websites and other sources of information that antineoplastons are somehow something magical and amazing. Of course, they don’t realize it’s nothing more than phenylbutyrate and, more importantly, that, if they have one of the cancers for which there is evidence of efficacy, they could ask their oncologist to prescribe the drug off-label, although their insurance may not pay for it. They also don’t appear to be informed that there is a significant body of published evidence about the safety and efficacy of phenylbutyrate and that the way Dr. Burzynski uses its metabolites A-10 and AS-2.1 often far exceeds what one might estimate to be the MTD.

What Burzynski is really doing

It appears that during his urine and blood purification process so many decades ago, Burzynski stumbled on known compounds, PA and PAG, and has been using them to treat all sorts of cancers at extremely high doses based on weak evidence of clinical efficacy (probably brain tumours are the only real indication where it might be useful). Despite the persistent lack of evidence that these compounds have significant anticancer activity in humans, he continues to use and promote them at his clinic, charging patients through the nose to join his clinical trials rather than joining in a wider research effort test the drug in the right way. Indeed, the Burzynski website is still putting out this line: “Antineoplastons (ANP) are peptides and amino acid derivatives, discovered by Dr. S. Burzynski, M.D., Ph.D. in 1967.” As the literature shows, however, what is probably one active metabolite (phenylacetate) was already being researched in the 1950s, and the other probable active metabolite, phenylacetylglutamine, was investigated in the urine of cancer patients in 1958. Burzynski didn’t “discover” these two chemicals. All he did was to purify them from urine, then throw them them at patients in extremely high doses. This he did for decades until, sometime in the last several years, he apparently discovered that these chemicals are metabolites of sodium phenylbutyrate; so he switched to that. Then, like the “brave maverick doctor” that he thinks himself to be, he decided that the way to sell his antineoplastons and phenylbutyrate was to “rebrand” them as part of his “personalized gene-targeted cancer therapy.”

What cancer patients considering going to the Burzynski Clinic need to know is that antineoplastons (or to give them their correct name, phenylbutyrate) appear to be no better than many experimental therapies at a very early stage of development. There is phase I data that has produced toxicity data and an MTD. However, there is no convincing evidence of efficacy, except maybe in certain brain tumors. Indeed, it is quite possible, based on the case report and phase I trial testing phenylbutyrate in patients with glioma, that Dr. Burzynski’s therapy does, almost quite by accident, produce the occasional complete response. The problem is that we have no idea if this is any better or worse than anyone else’s results because Dr. Burzynski doesn’t do the necessary phase III trials to find out, even though he has well over 60 phase I/II trials listed at PubMed over the last 15 or 20 years.

Be that as it may, Dr. Burzynski’s antineoplastons are not “natural, non-toxic compounds that cure cancer.” They are drugs, plain and simple. Worse, they are drugs of unknown efficacy. Nor is Dr. Burzynski doing anything unique or in any way superior to what cancer researchers elsewhere do, his claims otherwise notwithstanding. In fact, what Dr. Burzynski does and how he does it are a pale shadow, a parody, of what real cancer research centers do. He does “personalized therapy” so badly that it’s a joke, and he uses an orphan drug off-label in combination with other off-label chemotherapy drugs and targeted therapy while selling his combination as some sort of radical breakthrough in cancer therapy. Meanwhile, the alt-med underground promotes Dr. Burzynski as “the man who cures the most intractable cancers” naturally. He’s not. He’s being represented to desperate patients with incurable cancers as their “last hope,” worth any price to reach. After all, what price would you pay for your last chance at survival or that of a loved one? Of your child? To what lengths would you go to get to the man who, you are told, is the only man in the world who can save your life?

Unfortunately, it’s not even clear to me that Dr. Burzynski’s cured a single cancer. In fact, Skeptical Humanities has been tallying publicly available cases of patients who went to Burzynski and did not survive. It’s a depressing read, and these are stories we don’t see, even from much of the mainstream press. In the process, the harm he is doing is incalculable as he tarnishes the reputation of a perfectly fine experimental anticancer drug (phenylbutyrate) and the very concept of “personalized cancer therapy” with the stench of quackery. Certainly, it doesn’t help that of late he’s branched out into dubious anti-aging remedies, forming a new division of his clinic called AminoCare.

Unfortunately, what we have here is a case of crank magnetism, and the people who pay the price are the desperate patients enticed to spend tens of thousands of dollars for a combination of chemotherapy, thrown-together targeted therapies, and an orphan drug sold as something unique and brilliant.

Comments

  1. #1 Beamup
    March 26, 2012

    Have any of you watched the documentary about Burzynski?

    The commercial, you mean.

    Funny how his methods too have better results than modern medicine.

    Funny how he refuses to publish his results, if they really are better. It’d make him stinking rich and immensely famous, as well as saving countless lives, if his claims were true.

    Besides this guy talks about the Antineoplastons being toxins. Is chemo not?

    Burzynski is lying by claiming his ANPs aren’t chemo, is the point.

  2. #2 Lawrence
    March 26, 2012

    @lee – there are 197 comments above yours. I would imagine you might want to read at least some of them (which deal directly with the points you attempted to make), before making a fool of yourself….just saying.

  3. #3 JGC
    March 26, 2012

    Lee @ 197

    Documentary? With apologies to The Princess Bride, “You keep using that word. I don’t think it means what you think it means.”

    Burzynski the Movie isn’t a documentary: it’s an info-mercial for his clinic produced by a PR flack named Eric Merola who has no other ‘documentaries’ to his credit. It provides absolutely no evidence supporting antineoplastin safety or efficacy, instaed offering only cherry picked testimonials from three of Burzynski’s marks–I’m sorry, his “clients”.

    It’s been discussed here previously in detail–see http://scienceblogs.com/insolence/2011/11/burzynski_the_movie_subtle_its_not.php

    By all means recall that real scientists who are trying to demonstrate the validity of their claims don’t hire PR firms to produce documentaries about them, they’re theories or their medical practice: they submit their work to peer reviewed scientific journals for publication.

  4. #4 Alexandria
    March 27, 2012

    Most of the comments above come from a lack of understanding of what his practice consists of. If necessary a low dose chemo is used. The medication may be administered once a week at lower dose than large dose every three weeks. The newer drugs are called monoclonal antibodies and their job is to cut off the blood supply to tumors. Almost any cancer facility is going to use what is at their disposal to cure the patient. Chemotherapy comes from the a word meaning kill bad cells. Cancer is not a linear disease…it mutates, and what works on the “main” tumor will not work on lets say any growths coming form this original tumor. When these monoclonal antibodies were FDA approved, each one was tested on many different cancers. Therefore the one where the greatest efficacy was shown is the cancer the drug gets FDA approval for. But that does not mean in combination with other drugs that it can’t be effective on another form of cancer than the original approval. That is why FDA will later say it is effective for this cancer or that cancer. This is primarily what Burzynski does. So the fact that they are expensive, who dictates that fee, many of the Burzynski patients apply for free drugs, the clinic helps with the paperwork and presto, patient get drug free of charge. Does Burzynski care, no , he wants his patient to follow the treatment plan whatever it takes. As far a money, the clinic is out of network with every major commercial carrier. Therefore ins is billed for those with out of network benefits. If the ins pays and many times it does, the patient will be getting a refund from part of or close to all of the original money deposited. And if you think for one moment MDA, Cancer Treatment centers of America is free, then you are from fucking Pluto.MDA normally asks for a cashiers check for at least $125,00. Just ask them,and God forbid ins denies a claim and the patient is due to come in, guess what, they get to pay. Did you really think everyplace else is free…at least he is trying to do something. It appears we are always ready to find fault with the next person but God forbid we should shake his hand..People love to point fingers, blame, bitch about, because this is apparently all they have to do. His stats are no worse than any other facility..With all the billions of dollars donated to MDA or other “private institutions” no one has any idea how to cure even one cancer. Burzynski is not receiving one dollar of these massive donations given to these other facilities. I know what I am talking about, and what goes on day to day in many facilities. So before you start complaining and bitching and moaning, you go find a cure.

  5. #5 herr doktor bimler
    March 27, 2012

    His stats are no worse than any other facility.

    Sadly, “no stats at all” is worse.

  6. #6 adelady
    March 28, 2012

    “That is why FDA will later say it is effective for this cancer or that cancer.

    The FDA issues recommendations based on the confirmed results of properly conducted trials.

    This is primarily what Burzynski does.

    Not exactly. He gets approval to do certain things in accordance with FDA rules. Then he doesn’t deliver any results to be confirmed. If he has results suitable for consideration by the FDA, then they should be submitted.

    If he, and you, seriously contend that his approach is both more successful and has less side-effects than current therapies, then he is depriving many doctors of better treatments for their patients. Even worse, he’s denying many, many thousands of people across the world the benefits of his protocol.

    You say he’s serious about getting better outcomes than other doctors. If that’s true, he should get his results in to the FDA pronto so that everyone can benefit from this improvement.

  7. #7 herr doktor bimler
    March 28, 2012

    So before you start complaining and bitching and moaning, you go find a cure.

    So evidence of fraud, quackery, exploitation and barratry can be ignored unless the person pointing it out has personally cured cancer? That must save time.

  8. #8 Genius
    March 28, 2012

    LOL! Incredible. At first I thought Burzynski was a quack, then I read this post. It reminded me so much of the posts I read about the 9/11 inside job. I realize now that when this much hatred is directed at one man, and so much money and effort is placed in discrediting him, that he MUST be real! Burzynski is not a quack! He has saved many lives! What an American hero! If it wasn’t for all the hatred on this post I probably would have fell for it. Now I am definitely a supporter. It doesn’t surprise me at all how hateful the posters on this forum are, after willfully allowing so many children to die using antiquated radiation therapy methods. How sick of their own lives they must be to support vile human garbage like those at the FDA! Imagine, all that human suffering for a pithy 250 foot yacht. How insignificant is the wealthy person? So insecure and vain. Like the Enron guy who blew his brains out outside his home. These men have nothing. They are fools.

  9. #9 Chris
    March 28, 2012

    Genius:

    He has saved many lives!

    Prove it.

  10. #10 Narad
    March 28, 2012

    At first I thought Burzynski was a quack, then I read this post.

    Perhaps you should consider musical theater as a backup, as this dramatic performance was a bit less than convincing.

  11. #11 LW
    March 28, 2012

    At first I thought Bernie Madoff was running a Ponzi scheme, then I read this post. It reminded me so much of the posts I read about the 9/11 inside job. I realize now that when this much hatred is directed at one man, and so much money and effort is placed in discrediting him, that he MUST be real! Madoff was not running a Ponzi scheme! He has saved many fortunes! What an American hero! If it wasn’t for all the hatred on this post I probably would have fell for it.

  12. #12 Lawrence
    March 28, 2012

    At first I thought Jim Jones was a mass-murderer & cult leader, then I read this post. It reminded me so much of the posts I read about 9/11 inside job. I realize noth that when this much hatred is directed at one man, and so much money and effort is placed in discrediting him, that he MUST be real! Jim Jones wasn’t running a cult & all those people must be alive somewhere! What an American hero. If it wasn’t for all the hatred on this post I probably would have fell for it.

  13. #13 Marc Stephens Is Insane
    March 28, 2012

    Hey Genius! You should have stuck with your first thought…

    You’re right; there is a lot of hatred on this site aimed at people who take advantage of desperate, sick people.

    There’s an ex-doctor who injects baking soda into breast tumors; is he a hero? What about a guy who sells a drink made of industrial bleach? A hero? Someone else thinks he can cure cancer with coffee enemas–I guess he’s also a hero by your standards. What about all the psychic healers in Brazil who claim they can remove disease just by looking at you? They ALL say they can help people. All heros? Where do you draw the line?

    The point is all these quacks have plenty of testimonials from people who think they were cured of cancer by these con artists. Just because Burzynski is a bit more
    “science-y” doaesn’t make him any different from the other carnival acts with false claims and false hope.

    Thirteen days until April 11th!!!

  14. #14 josh
    April 23, 2012

    i wish some one would shoot you in the face for trying to make money over human lives. God i wish some one would. …And make some money off it!!! But people will believe your bullshit if you lie well enough. Right in the face.

  15. #15 josh
    April 23, 2012

    i wish some one would shoot you in the face for trying to make money over human lives. God i wish some one would.

  16. #16 Chris
    April 23, 2012

    Josh, threatening violence against Burzynski or anyone else is not helpful. Unfortunately all one can do is expose charlatans like him to prevent people from wasting their money on fraudulent medical claims.

  17. #17 Olivia
    April 24, 2012

    Listen! Dr Burzinsky has treated thousands of patients of cancer!! How dare you try to put that in a bad light?!? FDA, government, media are all LIARS, all manipulated by the masonic powers!! People need to stop sooo being naive and believe everything they are told by this shameful government!!!

  18. #18 LW
    April 24, 2012

    “THE GOVERNMENT CAN’T MAKE MONEY OFF WELL PEOPLE!”

    Really? They got a lot on April 15 off people who were well enough to work.

  19. #19 novalox
    April 24, 2012

    @olivia

    Conspiracy theory much?

  20. #20 Beamup
    April 24, 2012

    @ Olivia:

    You do realize that TREATING thousands of patients doesn’t mean BENEFITING thousands of patients? And that even if his BS works, he’s acting grossly unethically by charging astronomical rates for “clinical trials” that never get published? AND if we assume his claims are correct, effectively killing many more thousands by refusing to publish his results so that others may benefit?

  21. #21 Raging Bee
    April 24, 2012

    “Masonic powers?” Jesus fucking Christ, that’s the most obsolete conspiracy nonsense I’ve ever heard. Olivia, do you even know what the word “Mason” means?

  22. #22 Cynical Pediatrician
    April 24, 2012

    Never underestimate those nefarious bricklayers.

  23. #23 Cynical Pediatrician
    April 24, 2012

    Never underestimate those nefarious bricklayers.

  24. #24 JGC
    April 24, 2012

    MAYBE you should try writing a non biased report and get ALL your facts straight and stop trying to disprove a Doctor trying to cure cancer and start telling us why the government won’t approve this treatment.

    Because they can’t: there’s no evidence for the FDA to consider when weighing approval. Despite years of charging patients to participate in so-called clinical trials Burzynski hasn’t published his results nor provided the FDA the Phase I, II and III clinical trial results needed to secure approval. (While he theoretically has a Phase II trial open, it’s status has remained “not recruiting”.)

  25. #25 Bronze Dog
    April 24, 2012

    “Masonic powers?” Jesus fucking Christ, that’s the most obsolete conspiracy nonsense I’ve ever heard. Olivia, do you even know what the word “Mason” means?

    Never underestimate those nefarious bricklayers.

    I’m still trying to figure out how Urist McMason made an obsidian bed that’s comfortable for my nobles to sleep in and get happy thoughts. I know strange moods are supposed to let you make anything out of nearly any other material, but come on.


    Onto our most recent troll and possible Burzynski shill:

    People need to stop sooo being naive and believe everything they are told by this shameful government!!!

    You’re an idiot if you think this is about believing the government. The government isn’t influencing how we think about the case. We’re critical thinkers. We’re skeptics. We care about quality evidence, and we know something about scams. Burzynski shows every sign of being yet another con artist.

    You’re the one naively believing whatever someone’s been telling you.

    Meme:

    “THE GOVERNMENT CAN’T MAKE MONEY OFF WELL PEOPLE!”

    In addition to healthy people being able to pay taxes, I would think insurance companies want healthy people. Insurance companies don’t have to pay out anything if you don’t get sick. They make the most profit off of people who don’t make claims and don’t need medication. That’s why your premiums go up if you’re unhealthy: They have to get more money from you to counteract the extra claims they expect you to make.

    It’s like car insurance. If you’re an unsafe driver, they might not even accept you, for fear of paying more money in damages than they can squeeze from you in premiums.

  26. #26 DQ
    April 28, 2012

    This blogpost is somewhat helpful, but I was disappointed with a few inaccuracies and shaded statements which are intended not to get at the truth but obviously intended to denigrate Dr. Burzynski. You said he simply renamed existing drugs, but he has many patents. You said he interfered with the trials, but shouldn’t the actual protocol be testing, not an ineffectual variant? Is is success really just a “blind squirrel” phenomenon? Burzynski says it’s a game between the FDA and big pharma to discredit him. Seems like this article plays into that game. If this were a fair evaluation, you would look at the successes too (without the sarcasm).

  27. #27 Lawrence
    April 28, 2012

    @DQ – what successes? Dr. B refuses to publish his results….why exactly is that?

  28. #28 Militant Agnostic
    April 28, 2012

    I wonder why the all the Bullshitski shills are necromancy old threads, while none have showed up on the latest post about how credulous reporters are enabling fundraising by fresh marks.?

  29. #29 DQ
    April 28, 2012

    @Lawrence I think Burzynski says he is afraid to release the results mostly because of the decades of government attacks on him and his character. I wouldn’t be surprised if his lawyers advised he not release documentation that a government lawyer could cherry pick for possible violations of the law. They tried to indict him four or five times, but the grand jury refused. When they finally assembled a grand jury would would accuse him, they manufactured some 70 counts against him, of which only one minor count survived. He has spent millions defending himself against government persecution (yes, I think it would qualify as persecution at this point). So, really? You really want him to release more protocols? You really think it won’t just become evidence in another trumped-up legal argument? If you want to see the success, I suggest you look at the medical records release online by the patients themselves at http://www.burzynskipatientgroup.org/patient-medical-records. To say there is no evidence of success is like walking into the middle of a basketball game with earplugs and a blindfold and insisting there is no game. I suggest you examine sources other than those provided by the industry or the FDA or other government attackers.

  30. #30 Lawrence
    April 28, 2012

    @DQ – so, rather than release his results, which should, in your estimation, show overwhelming success of his protocols, he instead is trying to protect himself?

    That doesn’t sound very altruistic now, does it? Given that clinical trials are almost exclusively free, yet Dr. B continues to charge 100’s of thousands of dollars, yet refuses to publish any results for potential duplication, how exactly is this supposed to be considered kosher?

    And when people did try to replicate his treatment (I believe it was either Japanese or Korean researchers) they had to abandon their efforts because of the extreme toxicity of the treatment.

    Rather than watch a Dr. B propaganda movie, you should examine the facts that are available – that Dr. B has been able to abuse the FDA clinical trial process to con hundreds of sick people out of millions of dollars to support a treatment protocol that has no published data supporting that it actually works.

    After 30 years, isn’t it well past time to publish something?

  31. #31 Bronze Dog
    April 28, 2012

    Sooooo, producing test results, thereby potentially proving his good intentions and proving his treatments work would prove him guilty?

    So, because he suppresses his own science, that’s the reason he’s relying on well-known con artist tactics? That’s why he’s charging patients so much money for the privilege of being tested in a clinical trial (that’s biased by the money selection criteria instead of randomized) that will never be published?

    DQ, you’re advocating underhandedness as a research technique and claiming transparency is a threat. That’s the rationale of a scoundrel. This isn’t about treating cancer, this is about defending your lord guru, right or wrong.

  32. #32 Marc Stephens Is Insane
    April 28, 2012

    If Burzynski had any hard evidence to publish proving his claims, he’d win a Nobel prize, become a trillionaire and a world hero. Any theories that he’s deliberately hiding his results are insane.

    In addition, he uses chemo on most patients.

  33. #33 DQ
    April 28, 2012

    Okay guys, look, I got no chips in this game. As an outside observer it just seems odd that he would be attacked in this way for so long. Hopefully it’s encouraging to you that he’s in Phase II on I think 4 or 5 protoicols, and entering phase III on another. It seems to me that his very complicated protocols were previously so simplified in the trials that he knew they wouldn’t work and withdrew. He didn’t want to produce the contrary evidence you now cite in opposition to what is successful with his patients. He doesn’t want to release complete protocols so the drug companies can cut him out of the money stream by creating patents around him. Maybe that is selfish. I’m sure he wants to get paid, and if I were him I would want to get paid too. He has good reason to be paranoid. So, I hear what you’re saying, but at the same time, I’m skeptical of your skepticism. I think you just like the sport of debate. I don’t think you’re really thinking about the torture of chemotherapy as an alternative, and I don’t think you’ve read the stories of cured patients. His success cannot come from what you claim is essentially a placebo at best. It’s working. Does that count for anything???

  34. #34 Marc Stephens Is Insane
    April 28, 2012

    About this Holy Grail Phase III trial that all Burzynski’s defenders use to prop themselves up:

    It’s only ONE trial that’s been approved, and only for children, and it dates back to 2009. His target for the start of the trial was Dec. 2011. He needs to round up 70 subjects (a tiny number of subjects for any Phase III trial, by the way).

    We’re now almost into May 2012 and the trial is still not even open for subject recruitment. It’s unlikely he will ever begin this mythical trial.

  35. #35 Chris
    April 28, 2012

    DQ, has he recruited any patients for that phase III clinical trial? It was supposed to start months ago. Let us look at it. Nope, it still says “This study is not yet open for participant recruitment.”

    Looking at the list, of the sixty one clinical trials only one has been completed. That is not a good track record for thirty years of research.

  36. #36 Lawrence
    April 28, 2012

    @DQ – don’t you think by publishing his results in a public medical journal, it would serve to protect his “interests” as opposed to keeping them under wraps?

    His “phase 3” trial was supposed to start last year, but hasn’t yet – no reason given, even though he continues to “treat” patients.

    Since he doesn’t publish his results, how can you confirm his so-called successes?

    You also know he uses Chemo too, right?

    If I was going in for treatment, I would like to know that there is actual evidence to back up the efficacy of the protocol I was being given. In this case, all that has been provided is a bunch of stories, backed by the fact that Dr. B charges hundreds of thousands of dollars, when in the same circumstances with any other clinical trial, the patients aren’t charged a dime.

    There are plenty of legal mechanisms in place, should Dr. B need to protect his IP – in this case, though, because he isn’t providing actual results or data, it is a perfect cover for him to continue to siphon millions of dollars from his patients without any accountability at all.

    And, he can continue to claim to be a victim of the drug companies and FDA to boot, because his supporters love a “martyr.”

  37. #37 Bronze Dog
    April 28, 2012

    If anyone’s suppressing Burzynski’s research, it’s Burzynski. The only motivations I can think of are greed and delusion because he’s not doing what an honest, altruistic scientist would do.

    An honest scientist wouldn’t have any reason to delay publication of positive results for decades. If he got negative results, he would have moved onto more fruitful research long ago. If he suspected there was some flaw in the study, he would turn it over to peer review so they could engage in constructive criticism and he could start over and avoid those mistakes. Only a delusional scientist would keep testing after negative results, use cherry-picked anecdotes to falsely bolster his confidence and recruit test subjects, and avoid scientific scrutiny.

    An honest scientist wouldn’t charge patients ridiculous amounts to participate, because that would make the selection non-random, biasing the results and negating the study’s value. Patients who invest a lot of money into a treatment are also emotionally invested in interpreting their situation in a positive light. Statistical analysis is how we remove our rose-colored glasses.

    An altruistic scientist would instead pay for the study by asking for research grants and donations. He wouldn’t give out false promises of results, only that his treatment be given a chance to live up to his hopes. A con artist, however, would seek to make a profit by overcharging desperate patients for drugs that can be bought more cheaply. He would encourage people to spread cherry-picked testimonials to convince laypeople who don’t understand science. He wouldn’t publish his statistics and research methodology because that would allow scientists to discover the scam.

    An honest scientist wouldn’t take a long time to publish a study unless what he’s studying really and truly takes decades to gather the data and make conclusions from them. In the case of a long term cancer treatment study, he’d at least publish preliminary results of what happens in the first few years and then continue following the patients for longer increments. That way, if the initial results are promising, other scientists can try to replicate them, and not have to wait for decades.

    An altruistic scientist wouldn’t keep his research to himself. Science today depends on a culture of altruism. Scientists are expected to share information relatively freely. Science thrives with transparency and cooperation because new research depends on the reliability of existing knowledge. The era of the lone genius toiling in isolation is long dead because we’ve got good reason to think we’ve figured out all the “obvious” stuff. New research is about the fine details and nuances or the rare and exotic. A scientist who wants to find something new needs to know what others have already found out. Keeping your research secret from the world is downright Randian, because it depends on authoritarianism and the blind trust of consumers, instead of informed consent.

    If Burzynski is allowed to continue his scam, that sets a precedent for big pharmaceutical companies to do the same.

  38. #38 Narad
    April 28, 2012

    You said he simply renamed existing drugs, but he has many patents.

    Have you happened to read them? See if you might find some, ah, commonalities (aside from the obvious one of not really panning out).

  39. #39 Mephistopheles O'Brien
    April 28, 2012

    His success cannot come from what you claim is essentially a placebo at best. It’s working. Does that count for anything???

    If it were working, that would count for a great deal. “Working” in this case means that it provides results at least as good as the current standard of care. If you have high quality, statistically and scientifically sound evidence that this treatment works at least as well as the current standard of care, please share.

  40. #40 LW
    April 28, 2012

    Burzynski’s defender DQ @249 says that Burzynski doesn’t publish because it would cut off his income stream if others knew his protocol.

    In the first place, that is really reprehensible if he actually has a cure for any currently incurable cancer. He could save thousands, maybe tens of thousands, of lives just by releasing his protocol but he won’t because that would cut off his income stream, and DQ thinks that’s *understandable*? I think it’s utterly reprehensible. Or at least I would if I believed his claims.

    In the second place, I personally know a surgeon who came up with an effective treatment for a previously pretty intractable condition. What did he do? He did the clinical trials — not charging patients a penny for the treatment — and then he reported it in full: his protocol, the results in various patients, his hypothesis as to why it worked — everything. He gave lectures. He wrote follow-up papers. He did everything in his power to give the benefit to every patient he could.

    Did it cut into his income stream? Well, actually it couldn’t since unlike Burzynski he didn’t charge for experimental treatment. But he had all the patients he could handle because everyone knew he was the inventor. There’s a certain aura about the inventor that makes people want to see him even if others can do exactly the same thing.

    So I am totally unimpressed by this claim.

  41. #41 Militant Agnostic
    April 28, 2012

    Bronze Dog @253

    I hope you have that in a text file for quick pasting the next time a Burzynksi shill or apologist shows up. That is one of the best and most thorough smackdowns on the subject I have seen and we have had some good ones here.

  42. #42 Bronze Dog
    April 28, 2012

    I had considered making it a post on my blog. I think I’ll go ahead and post it and add appropriate links, later.

  43. #43 pv
    April 28, 2012

    Burzynski’s modus operandi is pretty much standard alternative-reality-medicine practice. Always jam tomorrow, and never any published or verifiable results. A marketing strategy predicated on exploiting people’s fears, and setting himself up as a saviour.

    In what way is Burzynski different from Bernie Madoff? Both rip off the savings of people trying to improve their future or protect themselves. In the case of Burzynski’s clients they are trying to save their lives. In the case of Madoff’s clients many were trying to provide for their old age.

    Madoff is now in prison, and rightly so. But what Burzynski does, it seems to me, is orders of magnitude worse and more disgusting because he exploits the dying and the resources and understandable desires of the relatives of the dying.

    All alt-reality-med is reprehensible because it is fraudulent and exploitative, but really is there anything more despicable than what Burzynski is doing? Why isn’t he behind bars?

  44. #44 B-rad
    May 3, 2012

    Wow. A lot of well educated people on this thread. I’m a bit distressed it disintegrated into emotionally driven silliness…but we are all human I guess.

    Regarding any problem: Our attitude on how we approach the issue has a great deal to do with how we form our understanding of results, whether they be motivation or demotivation to continue.

    I dare say, Orac, that you use the word “unfortunately”, “I hate to say”, etc. in alarming fashion in your article. You seem disappointed that some credit be given to Dr. B. I am concerned about your objectivity as such. But you are well educated, and seem a real professional. So kudos. Perhaps some introspection is in order to refresh your perspective.

    If we wish to solely focus on progress, then we would endeavour to focus on the results pertaining to gliomas, etc…and try to extrapolate from there…can we bridge such results into other types of malignancies? What are the mechanisms that have proven effective in the case of treatment of gliomas, and what can we do with that understanding?

    Instead, we focus on Dr. B and his monetary gain. All true. He seems to act in a proprietary fashion related to his research and treatment. A turn off, I get it. But is this truly relevant? Pharmaceutical companies have no scruples and are solely driven by profit (this is accepted knowledge). Does that mean that all of their drugs are ineffective.

    This avenue of critical analysis is a non starter. We seem to be mixing apples and oranges, and falling off topic. The objective is to focus on positive results, and drive forward to more positive results if they can truly be replicated. Are we thinking in this fashion? Truly?

    In addition, the propaganda that is Dr. B’s documentary (it is propaganda certainly) states openly that 3 out of 4 of his patients die with glioma. Yet, such a success rate is double/triple/etc. that of other modalities, with much less suffering…he seems to be open about that. So I am unsure why he is being labeled misleading as a “cure all.”

    A lot of people have passed, and more certainly will. So? Cancer is deadly, we all get this. Hence our interest. Again, perhaps we are off topic. Our focus on how he markets his treatments (target specific, tailored, etc). Yes, you dont like the labeling.

    Sure, again. Dr. B seems to have some businessman in him. So? What does that have to do with his results? Is he greedy. Maybe. So?

    And lastly, you focus often on derivatives of compounds, the fact that compounds (or their derivatives) are available at a cheaper rate somewhere else, the fact that these compounds,etc. have been in the realm of study for fifty years. So?

    I don’t understand. Please explain to a lay person. I am no genius, but buying bananas is not the same as a vial of Kcl (simplified, I know). But you get it. Again, he wants money, whether for his practice or to service his Mercedes. Ok, I get it. I don’t care about him as a person, I care about his data, and his positive results (few or many, whatever).

    I truly believe with all the brainpower on this thread, if you redirected your efforts to the study of the potential benefits (whether solely for glioma or other types)…the realm of cancer research would benefit greatly. No pharmaceutical companies required, because they are not to be trusted. Lets focus on his successes, and go from there.

    And forget peer review at this time. He is proprietary. It is his right. Perhaps unethical, but I dont have the luxury to care. The objective is to develop more and more positive results to save lives. So, we must broker some other form of cooperation with him. Maybe a better broker is in order here. More bees with honey…

    When you seek to discredit, you only discredit yourself.

    So the guy wants money. I get it. Expensive business he is in, and maybe he does drive a Mercedes. Who the hell cares. The children in his propaganda were not CG images…he has had some success…instead, this is the drivel. “Peer review”, “He charges a lot”… ????

    Please. He could be a billionaire octopus for all anyone cares. Why has he done well with gliomas? What can you scientists do with what we know about his successes? Lets try and build on this. Redirect your efforts, please.

  45. #45 Chris
    May 3, 2012

    B-rad:

    Why has he done well with gliomas? What can you scientists do with what we know about his successes?

    What evidence do we have that he has done well with gliomas? What successes? Where are the results of the clinical trials? Why is the first one on that list for gliomas not recruiting, when it was scheduled to start last year?

    How is asking those questions repeatedly “emotional driven silliness”?

  46. #46 novalox
    May 3, 2012

    @b-rad

    When he actually publishes some reseach about his “clinical trails” that can be critically analyzed (and no, propaganda “documentaries” don’t coun’t), then we can talk.

    Otherwise, judging by his refusal to publish, the unethicalness of his actually charging patients for his “trials”, and his harassment of people who question his “methods” via his “lawyers”, he deserves all the questions and scorn he gets.

  47. #47 B-rad
    May 3, 2012

    Chris,

    No desire to see objective data, studies would ever be considered emotionally driven silliness. Apologies if that was your impression.

    I believe the general consensus is that his modalities show some efficacy with glioma patients, as evidenced by the couple children highlighted in his propaganda whom have survived and prospered following his treatment. There seems to be some commentary saying same, though I am a lay man..so more research would be required to provide quotes.

    But imaging, etc shows remission. The “children” are now 20-25 years old. This seems convincing. But yes, I would like more data too. Perhaps we can broker that with a different approach.

  48. #48 Lawrence
    May 3, 2012

    @B-rad – you miss the point. We have no idea if he has been successful or not, because he has yet to publish the results of his work. It says something, as well, that other research groups that attempted to replicate his work had to abandon those efforts because the treatments, at face-value, were too toxic to continue to be used.

    As an educated group of people, we do demand evidence before accepting claims – and in this case, we have no evidence to speak of – so we are left with a Doctor (and I have to use the term loosely here) who has conducted his research over the course of 30 years, charging patients hundreds of thousands of dollars (whereas, your so-called Big Pharma charges nothing for clinical trials), starting numerous clinical trials as a means of “gaming” the FDA system, but produces no results that can be verified.

    “Big Pharma” is required to pass any new treatment or drug through a rigorous testing process & publish results of those trials for independent verification and replication. What about Dr. B places him above this process?

    What we have is a con artist, who has been allowed to take advantage of hundreds, if not thousands of desperate patients, all the while having him play the martyr card every time people try to demand actual evidence that he can do what he claims……seems pretty clear to me.

  49. #49 Chris
    May 3, 2012

    B-rad:

    I believe the general consensus is that his modalities show some efficacy with glioma patients, as evidenced by the couple children highlighted in his propaganda whom have survived and prospered following his treatment.

    We need the results of clinical trials, not two case reports. And there should be more evidence after thirty years of “research.”

    Even being a layman, you should have been able to understand that by the article and comments on this page. If you need help learning why there are issues with Burzynski’s lack of publishing results here are a couple of reading suggestions:

    Snake Oil Science: The Truth about Complementary and Alternative Medicine by R. Barker Bausell

    Lies, Damned Lies, and Science: How to Sort Through the Noise Around Global Warming, the Latest Health Claims, and Other Scientific Controversies by Sherry Seethaler

    Both books are easy to read, and sometimes humorous. They should both be available at your local library.

  50. #50 Lawrence
    May 3, 2012

    @B-rad – We all look forward to the results of your conversations with Dr. B & successfully getting him to release actual clinical data for study and replication….

  51. #51 b-rad
    May 3, 2012

    yup. i get it. lack of data to justify positive outcomes and further effort. logical. reasonable.

    but i want his data. so i am willing to accept (on the outside) his dubious proprietary practices to get it. he is just one man, and we don’t operate like that. but if he has anything that will help, i would like to get access for you scientific guys and gals to review it.

    there is some basis to support interest and effort in gaining access to his data. hence, this blog. but an overtly adversarial tone will not get us that access. im not being funny, i dont care who or what he is, including a rich octopus 🙂

    i just want his data to build upon. he wants to be paid for that. ok. fine. how much then?

  52. #52 Marc Stephens Is Insane
    May 3, 2012

    B-rad:

    I’ve said it before and others have said it more eloquently than me. IF Burysnki had any real breakthrough going on in his little clinic in Texas, he’d be shouting it from the rooftops. He’d win a Nobel Prize, be a worldwide hero and become a trillionaire. He’d be able to sell his treatment to the highest bidder, or license a chain of clinics around the world. And yet he’s hiding his breakthrough because we haven’t asked him nicely to show it us?

    He hasn’t shown any proof because he’s a fraud and his deceptive practices are the only way he can stay in business.

    And several people from the “movie” (i.e. commercial) and his website have died. No mentions, no memorials, no tributes.

    Oh, and one patient was dying while they were filming him for the movie but they used him in the final propaganda anyway.

    Can’t wait for this king of quacks to face the music with the TMB and lose his license.

  53. #53 Bronze Dog
    May 3, 2012

    The problem with Burzynski’s opacity and patient selection bias are suspicious on their own. He’s operating under the same conditions quacks do. If he was doing genuine scientific research, he wouldn’t be operating like that.

    Why should we give him special treatment? If he wants to convince us he’s right, he should publish his results in the medical journals like any other researcher. Until he provides evidence for his hypothesis, we’re justified in sticking with the null hypothesis: That his treatments don’t work.

  54. #54 Beamup
    May 3, 2012

    MSII is correct. If Burzynski actually had positive results, he would have published them. Full stop. Ergo, we can conclude with a fair degree of confidence that either he simply doesn’t bother to collect and analyze data, OR he does so and the results are negative.

    There is no “there” there.

  55. #55 Marc Stephens Is Insane
    May 3, 2012

    Oh, and B-rad, I’d suggest you read this story from the Houston Press, late 2008, where Burzynski reveals how mentally deranged he is:

    http://www.houstonpress.com/2009-01-01/news/cancer-doctor-stanislaw-burzynski-sees-himself-as-a-crusading-researcher-not-a-quack/

    In case you don’t feel like reading it all, here is the salient part where he calls the reporter, on the record, “a shit” with a “little brain” for daring to question him:

    “I have the right to do whatever research I want, okay?” he says, followed closely by, “I spent 42 years practicing medicine, doing research, and you are little man for asking such question, okay? Maybe in three years I get Nobel Prize, and you’ll look like a shit, okay, asking me such stupid questions, okay?”

    The Press explains that the reasoning behind the questions is this: Is Burzynski convinced that he’s done everything possible to get antineoplastons federally approved, and thus covered by insurance, thus giving a chance to those dying children whose parents can’t afford the steep payments? But when pressed as to why — even after the prolonged litigation with the FDA — he still hasn’t been able to prove his treatment’s efficacy, he is equally offended.

    “You know why?” he says. “Because I came to this country with $15 in my pocket, okay? Because I didn’t speak English when I came to this country. I learned it by myself. And in order for me to do what I am doing now, I needed to establish a pharmaceutical company. I needed to establish the research institute, okay, from the scratch, okay? And I need to do all of this from my own money, which I am, okay? How many years it would take for you to do it if you come to the country [from] like, say, Afghanistan?”

    The Press also asks why, if one of the biggest barriers to sharing a promising cancer treatment with the rest of the world is his language skills, he hasn’t enlisted the help of English-speaking scientists.

    Burzynski laughs that one off. “Listen your little brain to this thing: I came to this country with $15, okay? How can you enlist somebody, paying him $5 [out of] $15, okay?”

    Which leads to one of the most troubling aspects of the Burzynski saga: Why have no credible oncologists stood up for him? Why don’t oncologists regularly refer their patients to his clinic? Why aren’t the greatest minds in medicine calling for the swift approval of antineoplastons?

    If they are out there, the Press needs to hear from them. Burzynski obliges as best he can, throwing out the name of perhaps his biggest ally in medicine (using that term loosely). That is Julian Whitaker, an alternative medicine practitioner who claims to be “board-certified in antiaging medicine.” That could be true — it’s just a question of which board he’s talking about. One thing is for sure: It’s not the American Board of Medical Specialties, which is what most doctors are talking about when they say “board-­certified.” The ABMS does not recognize “anti­-aging” as a medical specialty. When asked for the names of supporting doctors who don’t have Web sites featuring “Rollback Savings!” on their lines of nutritional supplements, Burzynski eventually comes up with Bruce Cohen, a brain tumor specialist at the Cleveland Clinic. Cohen did not return calls.

    Does this sound like the kind of mentally-stable, rational person you’d give a quarter-million dollars to and trust with your life?

    And B-rad, are you aware of the mythical Phase III trial that will never get started?

  56. #56 madder
    May 3, 2012

    To Beamup’s comment, I would add:

    “…he simply doesn’t bother to collect and analyze data, and is therefore not actually conducting clinical trials at all…”

    not to nitpick, but just to hammer the point for benefit of b-rad and others. The two options seem to be that the data either don’t exist or are negative. Neither one helps Burzynski.

  57. #57 JGC
    May 3, 2012

    I believe the general consensus is that his modalities show some efficacy with glioma patients, as evidenced by the couple children highlighted in his propaganda whom have survived and prospered following his treatment.

    I’m afraid what you believe isn’t true: there is no general consensus that Burzynski’s ‘modalities’ show efficiacy in treating glioma patients, even if we were to take claims that a couple children highlighted in his propaganda have survived and prospered following his treatment at face value. We’re prevented from reaching any such concensus by Burzynski’s silence: his failure to publish results of his trials.

    but i want his data. so i am willing to accept (on the outside) his dubious proprietary practices to get it.

    You will never get his data, however, because Burzynski isn’t interested in demonstrating antineoplastin therapy works. He’s only interested in continung to be allowed to attract more and more desparate people willing to pay exorbitant sums to receive it to his clinic.

  58. #58 Marc Stephens Is Insane
    May 3, 2012

    From The New York Times way way back in 1996 about Burzynski. Nothing has changed in 16 years!!

    http://www.nytimes.com/1996/07/24/us/to-the-hopeless-a-cancer-cure-beckons.html?pagewanted=all&src=pm

    Here’s a nugget:

    Most researchers who find a promising treatment publish their results in a prestigious medical journal. Dr. Burzynski said he had submitted a paper to The New England Journal of Medicine, but that it had been rejected. “So to hell with them,” he said.

    Dr. Burzynski said that as with Einstein and Pasteur, history will prove him right. Cures like his, he said, “have never happened before in medical history, so if The New England Journal of Medicine refuses to publish my paper, why should I waste my time with these fools?”

    The F.D.A. has not approved antineoplastons because Dr. Burzynski has never completed clinical trials, controlled tests involving patients taking a new drug intended to prove whether a drug works and is safe. The agency will not discuss trials that are under way.

    The indictment of Dr. Burzynski states that “between 1983 and March 24, 1995, Dr. Burzynski had enrolled and treated only two patients under F.D.A.-authorized clinical trials.”

    Dean Mouscher, who is directing the clinical trials for Dr. Burzynski, said Dr. Burzynski was too busy treating patients, running an antineoplastons manufacturing plant, and conducting his own research to enroll patients in clinical trials to satisfy the F.D.A. Mr. Mouscher said he himself had a bachelor’s degree in French and “no medical background.”

    Pressed by the courts, Dr. Burzynski has put about 400 patients in clinical trials approved by the agency, Mr. Mouscher said.

    “We saw the handwriting on the wall and started putting everyone in clinical trials,” Mr. Mouscher said. The details of clinical trials of new drugs are considered proprietary, the F.D.A. said, but Mr. Mouscher said the agency was allowing Dr. Burzynski to give his drug only to patients for whom all other therapies had failed.

    Dr. Burzynski said he already had evidence from his patients’ experience. Some see their tumors shrink and others are cured, he said. And, he said, he can provide doctors who will back him up.

    One doctor he suggested, Dr. Bruce Cohen, a neurooncologist at the Cleveland Clinic, said that at the request of an insurance company he had a single session with a boy who had gone to Dr. Burzynski in lieu of receiving chemotherapy for a brain tumor. “His tumor did shrink on the therapy he received from Dr. Burzynski,” he said. That was four years ago, Dr. Cohen said. And, he added, “that was the first and last time I saw that child.”

  59. #59 ThisWebsiteIsOwnedByPharmComp
    May 7, 2012

    Is this article is a joke? It seems owned by a Pharma company. The reason why the FDA and Texas Medical boards are after him is because of the Pharm lobbyists. He owns that patents and they are trying everything to do to get him put in jail, thrown out, etc.

    Burzyinski has helped cure so many people after their Oncologists have already given up on them. As is the case with most Alternative treatments.

  60. #60 Mephistopheles O'Brien
    May 7, 2012

    @275 – do you have any evidence to back that up?

  61. #61 JGC
    May 7, 2012

    Burzynski’s cured so many people? If we assume that’s the case just for the sake of argument, one has to ask he would expect the FDA, the Texas Medical association or anyone else to ever know since he’s never bothered to publish the results of all those ‘clinical traals’ he keeps unethically charging patients to be a part of.

    Maybe we can start by asking you that question, ThisWebsite–how do you know he’s cured anyone? I mean, you do have actual evidence to back up your claim, I trust–something other than a collection of patient testimonials.

    Right?

  62. #62 Bronze Dog
    May 7, 2012

    The irony: The pharma companies would love to be able to operate the way Burzynski does. They wouldn’t have to do expensive clinical trials, just bluff about the “proven” efficacy of their new drugs by cherrypicking testimonials.

    To support Burzynski is to support the greediest parts of the pharmaceutical industry and undermine scientific progress.

  63. #63 Chris
    May 7, 2012

    Pharma Shill Gambit:

    Burzyinski has helped cure so many people after their Oncologists have already given up on them. As is the case with most Alternative treatments.

    Prove it. Show us the real scientific evidence. Post the titles, dates and journals that show the results of the Phase 3 clinical trials.

  64. #64 assassin of capitalist pigs
    May 12, 2012

    So who is paying your bills Orac? Pharma or the FDA?
    Whore!

  65. #65 novalox
    May 12, 2012

    I certainly hope that the poster assassin of capitalist pigs is a poe because that was such an idiotic post.

    But judging by the low intelligence of the post by the troll, I have a feeling that there may be a sock puppet with a inferiority complex or a burzynski fanboi.

    @assassin of capitalist pigs
    Like stated before, post some real scientific evidence.

  66. #66 herr doktor bimler
    May 12, 2012

    “Maybe in three years I get Nobel Prize, and you’ll look like a shit, okay, asking me such stupid questions, okay?”

    This was three years and three months ago. Oh dear, another deadline missed.

  67. #67 Marc Stephens Is Insane
    May 12, 2012

    Dok–that’s nothing. Did you see the interview I posted from The New York Times way back in 1996? Nothing has changed in 16 years!!

    http://www.nytimes.com/1996/07/24/us/to-the-hopeless-a-cancer-cure-beckons.html?pagewanted=all&src=pm

    Listen your little brain to this, okay? (from 1996, remember…)

    The F.D.A. has not approved antineoplastons because Dr. Burzynski has never completed clinical trials, controlled tests involving patients taking a new drug intended to prove whether a drug works and is safe. The agency will not discuss trials that are under way.

    The indictment of Dr. Burzynski states that “between 1983 and March 24, 1995, Dr. Burzynski had enrolled and treated only two patients under F.D.A.-authorized clinical trials.”

    Dean Mouscher, who is directing the clinical trials for Dr. Burzynski, said Dr. Burzynski was too busy treating patients, running an antineoplastons manufacturing plant, and conducting his own research to enroll patients in clinical trials to satisfy the F.D.A. Mr. Mouscher said he himself had a bachelor’s degree in French and “no medical background.”

    Pressed by the courts, Dr. Burzynski has put about 400 patients in clinical trials approved by the agency, Mr. Mouscher said.

    “We saw the handwriting on the wall and started putting everyone in clinical trials,” Mr. Mouscher said. The details of clinical trials of new drugs are considered proprietary, the F.D.A. said, but Mr. Mouscher said the agency was allowing Dr. Burzynski to give his drug only to patients for whom all other therapies had failed.

    Dr. Burzynski said he already had evidence from his patients’ experience. Some see their tumors shrink and others are cured, he said. And, he said, he can provide doctors who will back him up.

    One doctor he suggested, Dr. Bruce Cohen, a neurooncologist at the Cleveland Clinic, said that at the request of an insurance company he had a single session with a boy who had gone to Dr. Burzynski in lieu of receiving chemotherapy for a brain tumor. “His tumor did shrink on the therapy he received from Dr. Burzynski,” he said. That was four years ago, Dr. Cohen said. And, he added, “that was the first and last time I saw that child.”

    **************

    On a recent visit he presided over his clinic and showed no trace of modesty. Short, stocky and frenetic with crinkly blue eyes and a mustache, he compared himself to Einstein and Pasteur. “I am doing this,” he said, “because I am trying to help humanity.”

    **************

    He is certainly successful financially. The indictment claims that his gross income from 1988 to 1994 was $40 million, and that he took home $1 million a year. His practice is solely devoted to antineoplastons, and his clinic is the only one offering the treatment in the United States.

  68. #68 j
    May 12, 2012

    4 or 5 grand juries and no indictments!!!! And found not guity on another! And real people alive today because of it. All the proof I need! Obviously its not going to work on everyone. But even if it works 10% of the time its worth it. And anyone whose been through chemotherapy will tell u that!!

  69. #69 Chris
    May 12, 2012

    So what? What does the science say? j, show us the title, journals and dates of the PubMed indexed papers that show it even works 10% of the time.

  70. #70 Bronze Dog
    May 12, 2012

    I have more confidence in scientific data about scientific questions than I do in the legal system. The local legal system has far more loopholes and potential for corruption than the diverse international scientific community.

    It’s funny how with alties, state institutions are either an absolute, unquestionable authority or an corrupt, monolithic coalition of all the evils in the world, dependent on which way the wind blows.

  71. #71 Chief Critic
    May 13, 2012

    Your story is so full of shit! You are obviously in the crotch of big pharma’s RACE AGAINST THE CURE of cancer. Anyone who believes what they are told by the gov’t, FDA or Big Pharma is a puppet and a fool. You should be ashamed of yourself because anyone who knows about Dr. Burzynski know he has done more to help cancer patients than any other doctor(=whores) out there. Fuck you and your fuzzy science.

  72. #72 Nathan
    May 17, 2012

    Dr.Burzynski saved my mothers life

  73. #73 Marc Stephens Is Insane
    May 17, 2012

    Prove it then. Details please, not a six-word sentence fragment.

  74. #74 herr doktor bimler
    May 17, 2012

    You are obviously in the crotch of big pharma’s RACE AGAINST THE CURE of cancer.< ?i>

    Best mixed metaphor EVER.

  75. #75 herr doktor bimler
    May 17, 2012

    You are obviously in the crotch of big pharma’s RACE AGAINST THE CURE of cancer.
    Best mixed metaphor EVER.

  76. #76 Ender
    May 17, 2012

    Hey! My doctor(=whores) is the best doctor(=whores) there is, and has cured over 130% of Cancer in his patient! How dare you blacken his name you sheeple?
    He can’t publish his results because the FDA hates results and BIG PHARMA (=WHORES) keeps paying them secret money to stop him.
    Now I would like you to apologise to all doctor(=whores) out there for your foul sheeple calumny.

  77. #77 kabjoly@yahoo.com
    May 20, 2012

    Why did you spend so much time to write this bs article? or who is paying you to do so? Bottom line he’s saving people’s lives something you can’t even appreciate.

  78. #78 Thomas
    May 20, 2012

    “Why did you spend so much time to write this bs article? ”

    Wow. You’ve laid out the facts in such a detailed fashion, with well-documented evidence, that there is simply no way to doubt the accuracy of your conclusions… Not.

  79. #79 starr
    May 20, 2012

    he has SAVED LIVES.

    end of article.

  80. #80 Shay
    May 20, 2012

    Then why doesn’t he publish his findings, star, so other desperately ill cancer patients can benefit from them?

  81. #81 Science Mom
    May 20, 2012

    Re: kabjoly and starr; well we are dealing with someone who thought Marc Stephens was a spiffy idea. Why not these two?

  82. #82 elburto
    May 21, 2012

    Shay- who do you think you are, using logic and asking for facts!

    We should just believe what Bullshitski says, trust his weird little sycophants, or else be revealed as evil allopathic tools of teh BIG PHARMA!!!!111

    PS- Stan cured my pet goldfish of fin cancer. It was worth every penny to see Splashy Shinysides well again. A bargain at only £5,318,008

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