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The Texas Medical Board vs. Stanislaw Burzynski, 2014 edition

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As I begin this post, I’m on a miserably crowded, hot, stinky flight winging my way home from TAM. This puts me in the perfect mood to write about my bête noire to conquer all bêtes noires, namely Stanislaw Burzynski, the Polish expat doctor who claims to have much better results treating deadly brain cancers than conventional oncology, even though he is not an oncologist and has never even completed the prerequisite training for an oncology fellowship, namely an internal medicine residency. Actually, I don’t mean that in the way that you probably think I mean it. This time around, unlike the last time around, writing about Burzynski will put me in a better mood to endure being slapped into a sardine can in coach, barely able to move, barely able to type, but needing to get a blog post out on Monday.

If you remember, the last time I wrote about Burzynski, the Food and Drug Administration (FDA) had caved, and by “caved” I mean that it had lifted the partial clinical hold on Burzynski’s clinical trials. As is usual with the long and winding saga that is Burzynski, I feel compelled to give a brief review for any newbie who might encounter this post. Old hands at this story can skip ahead or just skim.

Two years ago, a child named Josia Cotto died of hypernatremia (elevated sodium level in the blood) due to receiving treatment for a brain tumor from the Burzynski Clinic using Burzynski’s “miracle drug” antineoplastons. Hypernatremia is a known complication of ANP treatment, and, as a result of this child’s death, the FDA put a partial clinical hold on Burzynski’s clinical trials for pediatric patients, which meant that he could continue to treat children already enrolled in his clinical trials but could not enroll any new patients. Six months later, this partial hold was extended to all of Burzynski’s clinical trials, and in early 2013 the FDA inspected the Burzynski Clinic and Burzynski Research Institute (BRI).

The reason why the FDA’s decision late last month to lift this clinical hold is so puzzling is because the results of the FDA’s inspection were so damning. In particular, the FDA found that Burzynski exaggerated responses to therapy using inappropriate criteria, didn’t have original scans of many patients, and played fast and loose with the rules regarding enrolling patients onto clinical trials under single patient INDs (otherwise known as compassionate use exemptions). Let’s just say that Burzynski’s institutional review board (IRB), the committee whose charge under the Common Rule (which clinical trials meant to be used as the basis for FDA approval of a drug must follow) wasn’t exactly rigorous about following federal regulations or protecting patient rights and safety, and let’s further say that Burzynski’s response was…less than convincing. More puzzling, this is not the first time that the FDA has investigated Burzynski and found the very same sorts of violations by the BRI IRB; it’s a pattern that goes back to at least 2001 and continued at least until the FDA inspection. Let’s just put it this way. IRBs are supposed to be as independent as possible, and Burzynski’s IRB has been (and still is) chaired by Carlton F. Hazlewood, PhD, who just so happens to be on the board of directors of the Burzynski Research Institute. The conflict of interest and lack of ethics are astounding. Yet the FDA still lifted the partial clinical hold, a breathtaking failure to protect cancer patients.

That was the bad news.

The Texas Medical Board tries to do the right thing

During this time, the Texas Medical Board, which has tried and failed to strip Burzynski of his medical license on multiple occasions over the last four decades, has decided to take another whack at the piñata. I’m glad it did, even though, as has been discussed before with respect to multiple cases, including Rolando Arafiles and Christopher Duntsch, the TMB is toothless by design, thanks to an anti-regulatory bias that has led to laws that have vastly weakened its already-weak regulatory authority. That’s why, although I’m not optimistic that this time the TMB will prevail where in the past it has not, I’m glad it’s giving it the old college try, which is what it has done with an amended complaint against Burzynski dated July 10, 2014. I warn you: It’s over 200 pages long, but the spacing and repetition are such that I was able to read most of it even though I was busy with TAM. It’s a devastating document that, if the allegations are proven in court, should finally end Burzynski’s career. I’ll apologize if I’m a bit pessimistic, though. Burzynski has slithered out of tighter spots before.

Still, it’s worth discussing the allegations. Because of the length of the document, I can only hit the high points, but the complaint is there for you all to read if you are so inclined. If you’ve been following the Burzynski saga it’s definitely worth taking the time to do so. The introduction sets the stage:

Board Staff alleges that Respondent created a medical practice model based on marketing his proprietary anti-cancer drugs to patients without adequate measures for patient safety and therapeutic value. Respondent misled patients knowingly by promoting these drugs as an attraction to bring patients to his medical practice when Respondent was aware that he could not legally include most of those patients in FDA-approved Phase 21 clinical trials of his proprietary anti-cancer drugs. Respondent further misled patients into paying funds as a retainer prior to receiving any evaluation, diagnosis or treatment. Respondent further misled patients into: (1) paying exorbitant charges for drugs and medical services; (2) accepting care from unlicensed persons while Respondent and Respondent’s employees misrepresented those unlicensed persons to be licensed medical doctors in Texas and the United States of America; and (3) accepting care from health care providers who had little advanced education or training related to cancer treatment while Respondent and Respondent’s employees misrepresented those health care providers to be doctors with significant advanced education or training related to cancer treatment.

Having followed the Burzynski saga for three years now, I’m always heartened to see when a regulatory or law enforcement body “gets it” the way this paragraph demonstrates that the TMB appears to “get it” now. This is in sharp contrast to the weaselly justifications by the FDA for unleashing Burzynski’s bogus clinical trials—which, recall, his own lawyer characterized as “an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment” so that Burzynski “would be able to treat almost any patient he would want to treat!”—on unsuspecting desperate cancer patients again. The new allegation that I hadn’t been aware of was the part about using health care providers with little or no education or skill and representing them to patients as being doctors. Now that’s really bad by any stretch of the imagination, and a profound betrayal of the cancer patients whose desperation led them to Burzynski.

Patient A

Several of those desperate cancer patients are described in the complaint. I’m not going to go through all the cases, because there’s a depressing similarity to them in terms of the allegations of Burzynski’s wrongdoing, but it’s worth discussing at least a couple of them. I’ll start with Patient A, not only because it’s the first patient listed but because it’s a different story than we normally see at the Burzynski clinic. This patient had suspected colon cancer. I say “suspected,” because at the time he first presented to Burzynski he had not had any biopsies.

Patient A presented to the Burzynski clinic with a diagnosis of “sigmoid colon carcinoma metastatic to the liver.” This diagnosis was made on the basis of imaging studies that showed lesions in the liver suspicious for metastases and a colonoscopy that showed a “polypoid mass consistent with high-grade dysplasia and suspicious for invasive adenocarcinoma.” This, unfortunately, is not an uncommon presentation of colon cancer, except for one thing. Usually, there’s a biopsy done. A cardinal rule for treating cancer patients is that you do not initiate treatment without a tissue diagnosis from a biopsy. This tissue both proves that the patient has cancer and identifies the kind of cancer it is. Indeed, these days, when molecularly-targeted therapy is being increasingly used, the tissue also allows analysis of gene expression patterns that can guide the choice of treatment. The situations in which it is considered acceptable to begin treatment of presumed cancer in the absence of a tissue diagnosis are very uncommon and boil down to rare cases where the imaging is pathognomonic of the kind of cancer suspected and the clinician judges that a biopsy would be too risky.

Basically, patient A should have had a biopsy of both his sigmoid colon lesion and one or more of his liver lesions. There was no reason not to do this, as colonoscopic biopsies and needle biopsies of the liver are in general low risk procedures and the treatment of colon cancer is, increasingly, being guided by newer gene tests. Now, in fairness, Patient A had refused to undergo a biopsy when his local physician had recommended it and also refused to consider chemotherapy with FOLFOX3 with Avastin after a biopsy, which is within the standard of care. However, if that’s the case then Burzynski should have refused to treat him. Not only is it considered a gross breach of the standard of care not to have a tissue diagnosis before treating a patient, but nearly all clinical trials for cancer treatments absolutely require a tissue diagnosis, which means that this patient was ineligible for any of Burzynski’s clinical trials. Instead, without even recommending a biopsy, Burzynski began to treat patient A with anticancer medications.

Now here’s the kicker:

9. At the time Patient A first met with Respondent and the other employees of the Burzynski Clinic, Respondent allowed Tolib Rakhmanov, a person who is not a licensed physician or health care provider in Texas or elsewhere in the United States of America, to represent to Patient A that Tolib Rakhmanov was a licensed medical doctor practicing medicine in Texas. Respondent and the other Burzynski Clinic employees under Respondent’s supervision and control continued to represent to Patient A and Patient A’s fiancee or to allow them to believe that Tolib Rakhmanov was a licensed medical doctor practicing medicine in Texas throughout Patient A’s treatment at the Burzynski Clinic.

10. Respondent and the other Burzynski Clinic employees under Respondent’s supervision and control referred to Tolib Rakhmanov as “Dr. Rakhmanov” in Patient A’s and Patient A’s fiancée’s presence. Respondent knew or reasonably knew that Tolib Rakhmanov signed documents, many of which were also signed by Patient A and Patient A’s fiancee, in manners that identified Tolib Rakhmanov as a medical doctor. Patient A and Patient A’s fiancée reasonably believed that Tolib Rakhmanov was a medical doctor licensed to practice medicine in the state of Texas. Respondent was responsible for the false, misleading and deceptive representation to Patient A and Patient A’s fiancée that Tolib Rakhmanov was a medical doctor licensed to practice medicine in the state of Texas.

Rakhmanov also performed tasks and services that obviously constitute the practice of medicine, including diagnosing and evaluating Patient A’s medical condition, making treatment recommendations, on numerous occasions (with all the dates listed). The TMB further alleges that Burzynski “directed and/or reasonably knew and allowed Tolib Rakhmanov, a person who is not a licensed physician or health care provider in Texas or elsewhere in the United States of America, to perform medical tasks that constituted the practice of medicine in the state of Texas in the evaluation, diagnosis and treatment of Patient A.”

Burzynski also promised the patient that he would receive ANPs and the FOLFOX/Vectibix treatment he desired, after which he demanded a large retainer for treatment. This is interesting, because Vectibix (generic name: panitumumab) is a targeted therapy that is only useful in cancers with a gene called KRAS that is not mutated. (KRAS is gene that is frequently mutated in colorectal cancer.) This is what I mean about how gene testing is becoming more important in colorectal cancer. Most colorectal cancers these days are tested for KRAS mutations to determine if Vectibix is an appropriate therapeutic regimen. According to the company’s website, Vectibix is “not indicated for the treatment of patients with KRAS-mutant mCRC [metastatic colorectal cancer] or for whom KRAS mutation status is unknown.” In other words, it was unequivocally not indicated for Patient A. That’s even leaving aside the issue of ANPs.

Actually, Patient A never received FOLFOX/Vectibix or ANPs. Instead, he received something else from Burzynski without his “adequately explaining to Patient A the difference in safety and efficacy between the therapy requested by Patient A and the therapy provided by Respondent and the employees of the Burzynski Clinic under his supervision and control.” Instead, Burzynski initiated treatment with phenylbutyrate. Remember phenylbutyrate? It’s the orphan drug that Burzynski touts as an ANP prodrug. Patient A also received a “partially FOLFOX equivalent regimen” consisting of oral Xeloda and intravenous Avastin, which I consider kind of a half-assed treatment that isn’t FOLFOX. Apparently Patient A improved for a while, which is quite possible given that he was receiving Xeloda (capecitabine), for which there is some evidence of efficacy, as well as Avastin, which is why it’s sometimes used as an alternative to FOLFOX. It’s unlikely that the phenylbutyrate did anything. I do have to note, however, that there is a passage in which “shrinkage” of a brain tumor is mentioned, which makes me think the TMB made a mistake and mixed up part of Patient B’s story with that of Patient A.

For some reason, Burzynski started changing drugs without adequate rationale. Eventually, the tumors started growing again, and the patient left Burzynski’s care, having paid an enormous amount of money, including a $4,500 monthly case management fee and a charge of $360 for 500 mg of sodium phenylbutyrate. During the course of Patient A’s treatment, Burzynski also used very expensive drugs that are not indicated for colorectal cancer, such as Afinitor (everolimus), which inhibits a protein called mTOR and is primarily used for kidney cancer and breast cancer, and Votrient (pazopanib), a tyrosine kinase inhibitor that blocks tumor growth, inhibits angiogenesis, and is used for renal cell carcinoma and soft tissue sarcoma.

The story is all very familiar if you’ve been following Burzynski and very depressing. There’s more, just in the case of Patient A, including failure to assess the patient’s mental status when recommending treatments, failing to provide anything resembling adequate informed consent, and having an ownership interest in the pharmacy dispensing the drugs Burzynski used, among other violations, but let’s move on to Patient B.

Patient B

Patient B is an interesting case, because part of it isn’t clear to me. In December 2010, Patient B had a diagnosis of brain cancer, which was successfully removed by craniotomy, which was followed by imaging studies that showed complete removal of the tumor. Post-operative chemotherapy and radiation therapy were recommended. Now here’s a part where it’s hard to understand what Burzynski did wrong if you don’t know a lot about him. The complaint alleges that Burzynski didn’t get a biopsy to confirm the existence of cancer before initiating anticancer treatment. Yet, conventional doctors had recommended postop chemotherapy and radiation, even though as far as they could tell the cancer had been completely removed. The difference is in intent. The chemotherapy and radiation therapy were being recommended as adjuvant treatments, in other words, treatments designed to decrease the risk that the tumor would recur, given that microscopic disease is almost always left behind. My guess (and it’s only a guess) is that Burzynski didn’t document that he was undertaking treatment for adjuvant purposes but rather made it sound in the medical record as though he were treating for therapeutic purposes for an existing cancer.

Later in the complaint it is alleged that “Respondent and/or employees under his direction and control failed to inform Patient B about the FDA-approved criteria for treatment with antineoplastons in one of Respondent’s sponsored clinical studies.” None of Burzynski’s trials that I can find are for the adjuvant treatment of brain cancer. They are, instead, for the treatment of existing brain tumors, most often recurrent or refractory brain tumors. Thus, Patient B almost certainly wasn’t eligible for any of Burzynski’s ANP clinical trials, because he had what we in the biz like to call “no evaluable disease,” often abbreviated NED, meaning that there wasn’t any currently detectable tumor whose response to therapy could be followed.

Next, we see the same depressing litany for Patient B as well, including lack of informed consent, failure to document treatment rationale, and, again, Burzynski Clinic staff who are not physicians being represented as such, including Tolib Rakhmanov and Larisa Tikhomirova. There again was the requirement for a large retainer to begin treatment. There was again the “bait and switch” in which Burzynski lured Patient B in with the promise of his ANP therapy and then used something different, including—of course!—phenylbutyrate, plus the usual witches’ brew of targeted drugs that we’ve seen before and that are not indicated in most brain cancers. It’s what I’ve referred to before as the “everything but the kitchen sink” approach.

In actuality, Patient B’s story in the complaint is poorly written and very confusing. I had trouble making heads or tails of part of it. It says that Patient B didn’t have any detectable tumor when he first consulted Burzynski in December 2010 and nails Burzynski for that, but then it describes Burzynski beginning treatment in February 2011 and an MRI scan:

On or about March 17, 2011, an MRI of Patient B’s brain revealed moderate decrease in the size of the brain lesion.

My guess, but I can’t be sure from the muddled and confusing description in the TMB complaint, is that this brain “lesion” was probably the inflammatory reaction to the patient’s surgery, which would have been expected to get smaller over the next three months anyway. A better way to say it would have been to be very clear from the start what the radiological findings were when the patient first approached Burzynski. If there was a lesion there, then it should have been pointed out whether it was suspicious for residual disease or whether the radiologists thought it was just normal postoperative changes. We can infer from the description that Patient B’s doctors must have thought that there was no residual disease, but then what is this “brain lesion” that was showing moderate decrease in size on March 17, 2011? I’m a cancer doctor who’s followed Burzynski, and even I’m not entirely sure what happened based on the description.

Be that as it may, many of the same complaints made against Burzynski for his treatment of Patient A apply to Patient B as well, and Patient B suffered considerable toxicity:

Respondent and other health care providers under Respondent’s direction and control treated Patient B without regard to the potential combined toxicities of drugs used pursuant to Respondent’s recommendations and directions. Respondent and other health care providers under Respondent’s direction and control referenced the case reports of other physicians not associated with the Burzynski Clinic as support for combined use of the drugs recommended and administered to Patient B. In those referenced case reports of physicians not associated with the Burzynski Clinic, however, those drugs were only used individually or in other combinations besides the combinations of drugs used for Patient B by Respondent and other health care providers under Respondent’s direction and control. In this regard, Respondent and other health care providers under Respondent’s direction and control violated the standard of care for reasons including:

a. Patient B suffered considerable toxicity affects.

b. Respondent violated the standard of care by failing to have an adequate medical rationale for this simultaneous use of these agents in anti-cancer therapy.

c. Respondent violated standards of adequate documentation by failing to document an adequate medical rationale for this simultaneous use of these agents in anti-cancer therapy.

d. Respondent also failed to adequately inform Patient B of this increased risk.

Same as it ever was. I note that Patient D’s case is a lot like Patient C’s case, one difference being that Sheryll Acelar was one of the non-physicians allegedly represented to the patient as a physician. Another name that came up as a Burzynski Clinic employees who was falsely represented to patients as being physicians was Lourdes DeLeon.

Patient G

Patient G is different in that Patient G was actually enrolled on one of Burzynski’s phase II clinical trials for a malignant astrocytoma of the optic nerve. For this patient, not only were there many of the same violations as listed for Patients A through F, but there were added allegations based on Burzynski’s treatment of the patient as part of this clinical trial:

14. Respondent failed to comply with federal regulations, the Burzynski Research Institute’s agreement with the FDA regarding the clinical study program for administration of antineoplastons and the approved protocols for the approved clinical study in which Patient G was enrolled. Such failures included Respondent’s direction and allowance for Patient G to be charged for the antineoplaston therapy and Respondent’s direction and allowance for these charges to be characterized as something else, “chemo prolong infuse” . This characterization was false, misleading and deceptive.

And:

40. The federal regulatory requirements for approval of single patient protocols for Phase 1 or Phase 2 clinical studies require that the investigator ensure that risks to patient/subjects are minimized and reasonable in relation to anticipated benefits.

41. Respondent, as principal investigator and as sponsor of the clinical study of antineoplaston therapy for Patient G, had a responsibility to ensure that risks to Patient G were minimized and reasonable in relation to anticipated benefits.

42. Ensuring that risks to patient/subjects are minimized and reasonable in relation to anticipated benefits requires (1) review of the subject’s medical records (history and physical examination) and (2) clarifying any outstanding issues with respect to the suitability of treating the patient/subject prior to granting institutional review board approval.

43. Respondent, as principal investigator and as sponsor of the clinical study of antineoplaston therapy for Patient G, failed to do the following to protect Patient G who was a patient/human subject in the clinical study of antineoplastons; (1) Respondent failed to take adequate measures to minimize risks to Patient G; and (2) Respondent failed to ensure that the risks to Patient G were reasonable in relation to anticipated benefits and the importance of the generalizable knowledge that may be expected to result.

44. Respondent’s failure, as principal investigator and as sponsor of the clinical study of antineoplaston therapy for Patient G, to ensure that risks to Patient G were minimized and reasonable in relation to anticipated benefits violated the standard of care, federal regulations, the Act and Board Rules.

This is the first time I’ve ever seen the TMB go after Burzynski for violating federal clinical trial regulations and human subjects research protections. I would like to see more of this. Another aspect of this case is unusual in that the TMB notes that the patient’s parent was allowed “to open an account whereby the public could read about Patient G’s medical and financial crisis and contribute money to that account.” The TMB alleges that Burzynski and his staff “reasonably were aware that the website that hosted this contribution account would provide any donations directly to the Burzynski Clinic to pay for the costs of Patient G’s treatment and that such costs had already been paid in advance by Patient G’s parent.” Patient G’s parent had a billing dispute with the Burzynski Clinic in which Burzynski refused to accept those donations as credit on Patient G’s account at the Burzynski Clinic and returned all the donations to the website that had acted as an intermediary for the donations. Burzynski also received significant reimbursement payments from an insurance company for Patient G’s care and refused to refund Patient G for benefits paid.

In other words, it’s all about making money from the dying and desperate.

And all the rest…

The TMB complaint also describes something that people who’ve been following the Burzynski case are well aware of, namely his advertising claims for ANPs, which are illegal under federal law because he made specific health claims for them and they are not yet FDA-approved for any indication. This is one thing that I haven’t been able to figure out. If a drug company did this, all the “natural health” advocates who defend Burzynski tooth and nail would howl bloody murder—and rightly so. But Burzynski does it, and he’s a hero being “persecuted” by the FDA and TMB. Ditto Burzynski’s failure to meet criteria for human subjects protection again and again, which are detailed very carefully in the last 30 pages or so of the complaint.

So what does it all mean? At the very least, it means that the TMB is serious this time. Does it mean that finally—finally—Burzynski is going down? I certainly hope so. Unfortunately, there’s no guarantee, and Burzynski has been found not guilty of similar charges before. Whatever happens with this case, thirty-seven years are too many, and no other cancer patient should pay hundreds of thousands of dollars for an ineffective treatment.

Posted in: Cancer, Clinical Trials, Politics and Regulation

Leave a Comment (71) ↓

71 thoughts on “The Texas Medical Board vs. Stanislaw Burzynski, 2014 edition

  1. Bob Blaskiewicz says:

    I’m starting to think that this Burzynski chap is not entirely a good doctor.

  2. K says:

    It’s a shame that the TMB complaint is a bit confused and shambolic in places – there are mix-ups between some of the cases and is confusing in places. Hopefully that won’t stop them throwing the book at him.

    1. David Gorski says:

      Yeah, clearly they mixed up part of Patient B’s history with that of Patient A, which is just plain sloppy. I realize there’s a certain format that has to be followed, such as stating that there wasn’t a diagnosis of cancer when Burzynski saw the patients, describing the treatment, listing the charges, etc., but, well, the sloppiness of much of the complaint did bother me. Sure, it’s possible that the TMB attorney’s office didn’t have much time to put it together, but even so…

      1. Enzo says:

        I hope they take the time to do this properly. The last thing we need is to leave Burzynski more room to wiggle out of this once again. Teflon quack.

  3. Lawrence says:

    The information regarding the IRB is particularly damning, as is the multiple misrepresentations of people at the clinic as “Dr’s” when in fact they were not…..despicable!

  4. James Peters says:

    I’ve said this before and I will say it again, why isn’t he in prison. His scam should be closed and any assets should be sold and given back to the families of his victims

    1. Lawrence says:

      Given the number of violations cited in the document (but do I wish they could have done a better job in the proof-reading department!) it is going to be hard for Count Stan to get out of some kind of punishment……

    2. Windriven says:

      Downstream MadisonMD estimates the Burzinsky has treated perhaps 20,000 patients. If he averaged $100,000 per patient that works out to $2 BILLION dollars. One can purchase a good deal of political cover for a tiny fraction of that.

      Also downstream Kathy wonders about Burzinsky’s tax history. After calculating his potential ‘take’ over the last 3 decades, I’d be interested in that too.

    3. Spectator says:

      We’re increasingly a society where laws are bent to whatever is PC in the context of the people manipulating the works. That can be left, right, up or down, but always away from truth.

      It is not always plutocrats with money, that trope provides convenient cover for far more malevolent activities. Money certainly figures in this case tho, perhaps in a starring role.

  5. @GeekPharm says:

    My guess about the “Doctors” that aren’t actually doctors are that they went to medical school in another country (and maybe even were licensed there) before moving to TX to join his clinic and either couldn’t pass the licensing exam or didn’t even bother trying.

    I predict that if the TMB is successful, he will simply close shop and move it all across the border to Mexico and continue doing what he’s doing,

  6. David Gorski says:

    Note that comments that are nothing more than pointing out typos or dropped words will be deleted after the error is corrected. It’s way better to e-mail Paul or myself about such things than to take up space in the comments with them. Just sayin’.

  7. Ben says:

    Test. Retest. Test some more. When you are done, TEST SOME MORE.

    This guy may indeed be a quack (very likely). However, how much evidence, EVIDENCE!, do we have that his methods do not work? Peer reviewed work? Published in journals? Tests by other folks?

    I reiterate – his patients are there voluntarily. They are pretty much under a death sentence anyway because the cancer they have. So, what gives you the right to tell these people how to seek medical treatment, live the remaining days of their life and choose their own path? Give them information, absolutely, but Let. Them. Decide.

    Maybe (and likely) his methods do not work. I say again and will keep saying – Show. Me. The. Evidence.

    So far no article I’ve read in SI has offered contradictory evidence backed up by empirical studies, only opinion. I see plenty of evidence presented that this guy actually is a quack, but nothing except aforementioned opinions that his treatments don’t work (and they may not.)

    1. David Gorski says:

      It is not up to critics to show that ANP treatment doesn’t work. It’s up to Stanislaw Burzynski to show that it does, something he’s failed at spectacularly, despite having had 37 years to test, retest, test some more and then when he’s done, TEST SOME MORE.

      The overall evidence from Burzynski and his supporters is consistent with the conclusion that ANPs have little or no anticancer activity.

    2. KayMarie says:

      So if I say injecting dihydrogen monoxide into subcutaneous fat cures cancer (I mean we all know how dangerous it is, it has to have an equal but opposite curative effect) I should be allowed to do it to whomever I want for however much money I want to charge until someone decides that they are going to waste the money to prove it doesn’t work.

      Research is rather expensive so that is why we usually ask that if you want to profit from it in some way (academic reputation included) you pay to prove it can work, and pay to prove it isn’t too dangerous to do to anyone. Science usually isn’t everything is always assumed to work until someone proves it otherwise. That whole extraordinary claims need evidence and the more extraordinary the claim the more extraordinary the evidence. Paradigm shifting stuff is out there, but it takes testing and retesting and doing enough good tests someone else in all the world decides it is worth testing it independently.

      As to “what is the harm?” (assuming the examples do not sound like harm to you for whatever reason) How many of the people who got NONE of the treatment they came for would have gotten 80% of the appropriate drug in the amount of time that you need to get it in for a good shot at a cure if they’d gone to a doctor who wasn’t just playing around with people to see if maybe some of this and some of that may work better than anything anyone actually researched before.

      These places (any of them) do not just accept those who have failed all other treatment so a WTH might as well do throw the spaghetti at the wall to see if any treatment sticks approach. Very often people try these un-scientific places first as they have slick advertising and generally do everything they can to keep you away from anything considered standard medical treatment.

      1. Spectator says:

        Of course using chemical dihydrogen monoxide won’t work! Cancer is evil, chemicals are evil, thus cancer thrives on chemicals.

        You have to use natural DHM, harvested from seawater! *

        * This is not original, compare the health sites touting sea salt vs “death salt” … I kid not.

        1. KayMarie says:

          I have read some of the our salt has completely different properties from your salt missives.

          Your body knows if that sodium ion came from big salt or not.

    3. R Miller says:

      You have the burden of proof backwards. Do you believe pharmaceutical companies should be allowed to distribute new drugs with no safety or efficacy data to the public, and only remove them once someone else finds they don’t work and/or kill people instead? If you believe this is not acceptable, what do you feel about Burzynski makes him an exception? It’s not only about Burzynski and ANPs, but about maintainingg a consistent standard that already should exist.

      You’re also creating a false equivalency in which we have no knowledge about ANPs outside of what is published as a clinical trial, thus allegedly no negative trial leaves us in the same position as having no positive trial. In the end, you are simply wrong, because the understanding that ANPs do not work is based upon our present knowledge of oncology, which is possible even if that evidence is not a direct clinical trial. If Burzynski had clinical data to counter those conclusions and challenge what is known about cancer, great – but as you admit, he doesn’t.

    4. WilliamLawrenceUtridge says:

      Test. Retest. Test some more. When you are done, TEST SOME MORE.

      This guy may indeed be a quack (very likely). However, how much evidence, EVIDENCE!, do we have that his methods do not work? Peer reviewed work? Published in journals? Tests by other folks?

      Yeah…the whole problem is there is essentially zero evidence that any of his piss extracts work despite existing for nearly 40 years. Despite this lack of evidence, he’s selling them to desperate cancer patients for hundreds of thousands of dollars. Which brings us to the real problem – Burzynksi is lying to the dying (and their parents) so he can turn their hope into fat profits. He’s an unethical shithead who has never tested anything – merely strung people along unethically until they died, then invoiced their estates.

      I reiterate – his patients are there voluntarily. They are pretty much under a death sentence anyway because the cancer they have. So, what gives you the right to tell these people how to seek medical treatment, live the remaining days of their life and choose their own path? Give them information, absolutely, but Let. Them. Decide.

      They may be there voluntarily, but under dishonest circumstances. In fact, the whole thing is dishonest – he’s using the sham of clinical trials to make money off of the dying, and lying to them the whole time. Would you be OK with Pfizer doing this, just saying “well, they’re dying anyway, let’s try to shave down their bank accounts on their way”? If not, why is it OK when Burzynski does it?

      Lying to peple hardly seems more ethical or acceptable merely because the people are dying. In fact, I would venture that the ethical burden to provide proof is higher because of the desperation. Burzynski isn’t selling used cars here, he’s telling parents he can cure their children’s cancer.

      Maybe (and likely) his methods do not work. I say again and will keep saying – Show. Me. The. Evidence.

      There. Is. None. That’s rather the point. The only evidence that exists shows that Burzynski is a bad-faith player doing his best to manipulate and game the system in order to milk profits out of the desperate.

      Call me crazy, but I think there should be evidence of efficacy before you sell an alleged cure to a cancer patient for $150,000.

      So far no article I’ve read in SI has offered contradictory evidence backed up by empirical studies, only opinion. I see plenty of evidence presented that this guy actually is a quack, but nothing except aforementioned opinions that his treatments don’t work (and they may not.)

      Well, if you really want to, you could go to pubmed and type in Burzynski, S. You get 49 results, most of which are irrelevant, and the only clinical trials are essentially partial reports that, upon analysis, show that his piss extracts are worthless.

      Why are you giving this guy the benefit of the doubt? His own lawyer has said “the clinical trials are a sham to make money”, yet you still somehow think his piss extracts are doing anything? Why?

      1. Daniel Thomas says:

        And about Chemo, or Radiation, does they work? Of course, not, so why are the doctor who prescribe this are out of the jail? Answer, US$ 100,000.00 just pay the first month of treatment.

        1. WilliamLawrenceUtridge says:

          Chemo and radiation do work, depending on the cancer, the stage of cancer, and the goal. They are not always curative, for many tumors or cancers they are palliative – extending life and reducing misery without eliminating all malignant cells. In some cases they are purely to reduce the size of a tumor to make excision easier. Claiming chemo and radiation don’t work doesn’t make them actually stop working. But each use of chemo and radiation is supported by clinical trials in humans, compared to either no treatment (rare these days) or best available options, as part of a well-structured research design. These clinical trials are generally free to the patients as well.

          In contrast, Burzynski’s lawyer has explicitly stated that the “clinical trials” are a sham to avoid being shut down by the FDA. They cost patients a lot of money – not for piss extracts, but for “case supervision” by non-doctors. The piss extracts, the apparently magical thing that Burzynski is ostenstibly testing, are given as part of a mish-mash of chemotherapy that essentially ensure you’ll never, ever be able to tell if the piss extracts actually do anything.

          The assertion that chemo and radiation don’t work is a lie told to you by the CAM providers who want to sell you their own crap which doesn’t actually work. Chemo and radiation are brutal and very hard on the body, but they do work given a specific purpose. As I said – it’s not always a cure, but you might get an extra six months of life, or three months where the tumor isn’t pressing on a nerve and therefore isn’t causing intolerable agony. Cancer is awful, cancer shills and assholes like Burzynski make it worse by exploiting the hopes and fears of dying patients or desperate parents. It’s contemptible.

        2. n brownlee says:

          You are badly mistaken. I know a dozen people who are cancer-free today, cured by surgery, chemotherapy drugs, and/or radiation, in various combinations. I, personally, am alive and walking around because of chemotherapy.

    5. MadisonMD says:

      @Ben:
      According to the Cancer Letter, Burzynski treated 963 with ANP in 1997 alone. This means he is sitting on the chart of upwards of 10,000 patients treated with ANP. Actually, easily over 20,000 at that rate since he has been giving ANP over 30 years. Yet, only a few cherrypicked case reports dribble out.

      So, now consider the patients who are there voluntarily. Lets assume you are in opposition to government regulation of medical care, and want to get back to the wild era of patent medicines. (Have you thought that through, really? Read this.)

      Well, even if you are such a free-market extremist for unregulated medicine, is it your opinion that Burzynski may give them a false impression of efficacy by focusing on the 5 of 10,000 = 0.05% previous patients who had the best outcomes? That clearly fails to qualify as informed consent.

      1. WilliamLawrenceUtridge says:

        If Ben is such a free-market absolutist, I wonder if he would be equally in favour of Big Pharma selling whatever they want to whoever wants to buy it. Or anyone providing medical care to anyone willing to pay for it. “Surgeons” (i.e. anyone who happens to own a knife) operating on whoever is willing to fork over the cash. Hell, Ted Bundy would be willing to do it for free!

        1. MadisonMD says:

          Perhaps he would select a slick-appearing barber-surgeon who re-uses bloody rags dried on a pole. A shave, a haircut and a lobotomy… two bits.

        2. Windriven says:

          “Ted Bundy would be willing to do it for free!”

          Risk free!

    6. Sugarbubbie says:

      I am so tired of this quack doctor having people defend him and his illegal treatment of cancer patients. To me (as a cancer patient, not once but twice) he is insulting the many oncs and patients who undergo the clinical trials it takes to get treatments approved. It’s a slap in the face to those of us who have participated in a trial (which I have) not knowing if it was going to work or not, but wanting to possibly help future cancer patients if it did. He needs to go to jail and those who defend him should be ashamed.

    7. Ric Schiff says:

      Gorsky is fully aware of the articles that have been published. For your edification they are on http://www.anpcoalition.org

      Gorsky spends a great deal of time and effort pontificating on a topic which has already been decided. Does ANP work? The FDA says that it clearly shows efficacy. They have completely ignored Gorsky’s mindless pleas to black list ANP and DR. Burzynski…..why? Because their investigators spent 3 months at the Clinic with full access to all the documentation. What does it mean when the FDA restores the IND after a partial clinical hold? It means that either they were wrong about their initial concerns, or any concerns have been mitigated.

      So what is Gorsky saying? That the FDA is in league with BRI? To gain some political favor? Does that really make any sense?

      What indeed….does Gorsky have to gain by misleading everyone as he does? That’s a very good question.

      1. David Gorski says:

        Poor Mr. Schiff. Can’t even spell my name right. Or maybe he thinks it’s an insult. Who knows?

        In any case, one notes that this is the same Mr. Schiff who set up the ANP Coalition while still on the board of directors of the Burzynski Research Institute, a rather unethical thing to have done that set him up with a massive conflict of interest. No wonder he had to step down from the board of directors after less than a year.

        As for those studies, they do not show what Mr. Schiff thinks they show:

        http://scienceblogs.com/insolence/2014/04/17/stanislaw-burzynski-publishes-42-5-of-one-clinical-trial/

        http://scienceblogs.com/insolence/2014/06/09/stanislaw-burzynski-publishes-his-antineoplaston-results-again-its-no-more-convincing-than-last-time/

        Perhaps theses posts should be crossposted to SBM, just for completeness’ sake when it comes to our discussions of Stanislaw Burzynski.

        As for what it means that the FDA caved by removing the BRI’s partial clinical hold, well, this is what it means:

        http://www.sciencebasedmedicine.org/stanislaw-burzynskis-propaganda-victory-on-antineoplastons-the-fda-really-caves/

        One notes the straw man argument in which Mr. Schiff suggests I’m arguing that the FDA is somehow in league with BRI. Any objective reader of this post with a reasonable level of intelligence would not come away with that message at all, because, of course, that is not what I said. May I suggest that Mr. Schiff read the post again, that is, if he bothered to actually read beyond the first paragraph the first time? It’s the least he could do, given the tens, if not hundreds, of thousands of words’ worth of scientific papers, blog posts, and the like by Burzynski and his supporters that I’ve read.

        As for political pressure, we know it happened in the past, back in the 1990s. So why is it so unbelievable that it might have happened again? Perhaps this video will help:

        http://www.sciencebasedmedicine.org/medical-cranks-why-we-fight

        Or this article in Skeptical Inquirer:

        http://www.csicop.org/si/show/stanislaw_burzynski_four_decades_of_an_unproven_cancer_cure/

        As for the “cui bono? argument Mr. Schiff makes at the end, the answer is: Certainly not me. Not only do I get no financial benefit (contrary to how Mr. Schiff clearly implies that I do) from deconstructing Burzynski’s claims, but time to time I have to put up with considerable harassment from Burzynski supporters, who seem to think that it will make any difference to complain to my dean about my criticism of Burzynski. I do, however, get the satisfaction of doing the right thing, whatever the other prices I pay for my criticism of Burzynski’s lack of science and abuse of the clinical trials process.

        1. Bob Blaskiewicz (@rjblaskiewicz) says:

          I’ve often wondered how the most hardcore of Burzynski’s supporters, and Ric is certainly one of them, reconcile the endless reports from patients that getting worse is getting better. Or how, when a Clinic is packed with phony doctors, they excuse that? They don’t even blink. I just don’t understand it.

          1. Windriven says:

            “They don’t even blink. I just don’t understand it.”

            10-20,000 patients over the last 30 years at, let’s say it is only $50,000 per on average. At the lowest reasonable estimate that amounts to half a BILLION dollars. On the upper end of reasonable it is closer to $2 billion.

            With that kind of money you don’t need to blink. You can afford all the Visine you need.

      2. MadisonMD says:

        Does ANP work? The FDA says that it clearly shows efficacy.

        What a blatant lie. Why, if you are on the board of directors, would you expose yourself to legal risk by making a blatantly false statement about the efficacy of the product? Why would you imply FDA approval when a NDA has not even been filed?

        That is very, very foolish.

        1. David Gorski says:

          Well, he’s not on the board of directors of the BRI anymore; so I guess he can say anything he wants now.

          It is, however, interesting that after all this time Mr. Schiff has so little comprehension of what removing the partial clinical hold means. Hint: It doesn’t mean that the FDA is on the verge of approving antineoplastons for anything. Nor does the resurrection of that phase III trial, which in its first incarnation was never opened and therefore never accrued a single patient.

        2. MadisonMD says:

          B. and his cronies seem to think that the plan to open a phase III trial is evidence. That is a very odd concept.

          Frankly, a phase III trial of ANP is not feasible:
          (1) Patients who ‘believe’ will not want randomization to control arm (temozolamide? or require entry after standard radiation with no treatment control).
          (2) Phase III will require more patients than phase II with more strict eligibility criteria (e.g. radiation and perhaps no prior temozolamide for one). If he is averaging 1 patient/year accrual of phase II, then he will never complete a roughly 1-200 patient trial.
          (3) Patients who are randomized to control will incur far fewer costs than those randomized to ANP. I mean, ethics has never been a barrier before, but can it be possible that he charges patients $10K+/month if they are randomized to ANP and nothing if they are randomized to control?
          (4) Endpoint. What will he select for endpoint? Overall survival would seem to be the only viable choice as progression-free survival or response are poor surrogates. What this means is that there can be no crossover; i.e. once a DIPG patient is randomized to the control arm, that patient will not be able to receive ANP at all. That would not be popular for individuals that seek treatment with B.

          For all these reasons, a phase III trial simply cannot and will not ever be done by B. His only hope is to get his many phase II trials open again, but I’m not sure of the removing of the partial clinical hold will allow this?

          1. WilliamLawrenceUtridge says:

            Not to mention, what about his “kitchen sink” protocol for cancer treatments? Will he just keep randomly giving out high-dose chemotherapy along with half getting piss extracts and the other half just getting massive doses of sodium in an IV? How do you control for the hodge-podge of different and irrational chemotherapies he doses each patient with?

            The data will be scatter, meaningless scatter. His favourite kind. I wonder what percentage of results he would release, would he stick with 42.5% for continuity, or maybe go to 17.6%, or perhaps 66.6% for the symbolism?

      3. WilliamLawrenceUtridge says:

        The FDA says that it clearly shows efficacy.

        Really? Where? Such a dramatic statement is simply begging for a URL to substantiate your point. Could you please link to the FDA webpage that says piss extracts work?

        What does it mean when the FDA restores the IND after a partial clinical hold?

        Well, as Dr. Gorski points out in his post on the topic, it means that considerable political and public pressure has been put on the FDA, mostly by parents of dying children who have been lied to by Burzynski to make them think he is their last hope. That’s, in fact, rather the problem – Burzynski has been able to lie, cheat, misrepresent and game the process for decades. When he’s finally essentially forced to reveal his data, it turns out that his patients actually die pretty much as you would expect – in pain, from untreatable cancers (and sometimes from so much salt their body shuts down).

        That the FDA is in league with BRI? To gain some political favor? Does that really make any sense?

        Not to gain political favour, to avoid public pressure. The FDA is a politically-based entity, like all public entities. And like those political entities, its survival, resources and authority come from a political process, politicians making decisions about its budget, staffing and powers. Those politicians in turn base their decisions in part on pressure from constituents. Which is why Burzynski is putting such effort into patients, with their pathos-filled stories and dying children, lobbying news and government. Because with that kind of press, the FDA gets painted as a bad guy and the politicians have to look humane if they want to be re-elected.

        It’s the very worst of democracy in action, sadly. And it makes perfect sense.

        What indeed….does Gorsky have to gain by misleading everyone as he does?

        What’s misleading? You asked a whole bunch of leading questions, which have actually been answered here and elsewhere, and proclaim you have won. The only misleading thing here is that you are pretending that the answers don’t exist. You shithead.

  8. Kathy says:

    I wonder what his tax situation is? Remember Al Capone.

  9. Nathan Miller says:

    Thanks Dr. Gorski for the summary and exposition on some of the document’s murkier areas. There was certainly a lot of repetition of problematic practices described among all the patients, which I hope will speak to a modus operandi, but I’m also hopeful (though hoping my optimism isn’t misplaced) given the emphasis placed on “The Respondent” having an overriding role over direction and recommendations of the clinic’s employees.

  10. Frederick says:

    @geekpharm I thought that too, something other country standards are different, but in any case it is totally unethical to let yourself being presented as a doctor when you are not. Every ones of his employees seems to be bad people as much as he is. For me this whole clinic seem more and more like a cult.

    I try hard not to hate people, but I hate this man, and everybody who work for him. This comment is only a angry comment, don’t take that as a literal comment, But damn I want to go there and kick the ass of everyone working there, and punch That burzynski in the face with my Friend EASTON.

    He his your bête noire, But in Quebec , he also Qualify as ”un tabarnak de crosseur”.

    1. @GeekPharm says:

      I totally agree with you. I hope my comment didn’t sound like I was trying to excuse them for it. It is completely unethical, just like everything else happening at that clinic

  11. Mike says:

    Lourdes Deleon shows up in poor Denise D’s blog entries as “Dr. Deleon.”

    The LinkedIn of Sheryll Acelar says she graduated from St Luke’s College of Medicine in 2004. This is a school in the Philippines. Acelar shows up as “Dr. Acelar” in the stories of Brynlin S., Evan W, and Kenneth J.

  12. Derek Freyberg says:

    It is interesting that all of the patients who form the basis of the Complaint went to Stan wanting ANPs and only one of them received them, and these are patients who came to the Burza Clinic back in 2009/2010 or so. I wonder how much of Stan’s business of late is in ANPs, and how much is in “oncology for dummies”.
    Another interesting thing is that two of the seven walked away from Stan, one in only a week.
    And the sodium phenylbutyrate (the “kinda sorta ANP” that Stan can legally dispense outside of a clinical trial). 500 mg/day. That’s less than 100 mg sodium. It’s almost as if Stan caught on that hypernatremia from “real” ANPs is not such a good thing, but this way he can still talk ANP-type hype to his patients.
    It is a pity that the Complaint has some obvious errors, such as the ones that Dr. Gorski has commented on, and perhaps some less obvious ones as well; but I assume that the TMB can correct the record when the case gets to an Administrative Law Judge.

  13. Kim says:

    I still want to know why no one has *ever* survived diffuse glioblastoma brain cancer *except* some of Dr, Burzynski’s patients. He’s got to be on to something.

    1. n brownlee says:

      Where did you get that idea Burzynski’s flacks? Even a quick Wiki search (with searchable, solid references) could disabuse you.

      “UCLA Neuro-Oncology publishes real-time survival data for patients with this diagnosis.[64] They are the only institution in the United States that shows how their patients are performing. They also show a listing of chemotherapy agents used to treat GBM tumors.Despite a poor prognosis, there are a small amount of survivors that have been GBM free for more than 10–20 years.

    2. MadisonMD says:

      I still want to know why no one has *ever* survived diffuse glioblastoma brain cancer *except* some of Dr, Burzynski’s patients.

      If you want to be taken seriously, you should be both specific and accurate. You are neither. First, I believe you mean diffuse intrinsic pontine glioma (DIPG). Second, your statement is easily demonstrated to be false:
      1. Vallero et al. demonstrate one patient with survival exceeding 5 years (which comprises 4% of patients).
      2. Jenkin et al. report a 5-year survival of 20% for brainstem tumors, and historical reported rates of 0-38% 5-year survival.

      Now contrast these results with B’s. Burzynski’s only long term survivor in his recently published “DIPG” paper actually had pilocytic astrocytoma, a benign CNS tumor with a 5-year survival of 92%.

      Most reputable researchers talk about median surivival, which is indeed pretty dismal for garden variety DIPG and often <1 year. Burzynski talks about the 'best case scenario' which may, for all we know, occur in <1% of his patients. We are not told what the median survival of all treated patients. The best case scenarios that he has published, when evaluated, seems due to some result due to a more indolent tumor type, and has nothing to do with treatment.

      If you are looking for better treatment options for DIPG, the Pittsburgh group has published some promising preliminary vaccine results. Incidentally, they also have one long-term survivor, which again belies your claim.

      1. David Gorski says:

        Yes, spontaneous regression of DIPG is rare, but, contrary to what Burzynski claims (he claims that no one has ever survived DIPG), spontaneous regressions do occur, and some patients, even though their tumors don’t regress, survive a very long time with DIPG:

        http://www.sciencebasedmedicine.org/stanislaw-burzynskis-propaganda-victory-on-antineoplastons-the-fda-caves/

        There’s even a website that keeps track of such cases:

        http://dipg.blogspot.com

        And case reports:

        http://www.ncbi.nlm.nih.gov/pubmed/16206736

        Why does Burzynski keep lying about this?

        1. WilliamLawrenceUtridge says:

          Why does Burzynski keep lying about this?

          I’m going to go with “money”.

          The real question for me is, why is it not easier to find out that DIPG isn’t a death sentence? Why don’t patients find this out sooner from non-Burzynski sources? It took me minutes of digging to get some results showing infrequent long-term survival. Why don’t the major sites discussing it (hospitals, the NIH, Mayo Clinic, etc.) note the rare occurrence of survival?

          Of course, even the most lethal of cancers (small-cell lung and melanoma?) have survival rates in the low single-digits. Sure, they’re incredibly deadly, killing most very quickly – but not all. Some survive. So being able to isolate single cases is never, ever meaningful, no matter what the disease. There will always be some who live.

          1. Missmolly says:

            ‘Why is it not easier to find out that DIPG is not a death sentence?’
            The problem is that (in paeds, anyway), survival is absolutely dismal for true classic DIPG, and there is currently no treatment that prolongs survival above palliative radiotherapy. So you need to be clear with patients and their families that the therapy you’re proposing is to buy them time, and if a miracle happens and they survive longer it’s because the tumour behaved unexpectedly. It’s an aphorism in paed onc that if a kid with DIPG lives 3 years past diagnosis, they never had DIPG to begin with.

            We want them to spend their remaining lives living as hard as they can, in the knowledge that every extra day together is a gift. Then they can actually be prepared and make good choices about site of dying, advanced care planning, legacy making etc when/if they do start to progress. Focussing disproportionately on the tiny number who do well muddies parents’ abilities to understand how concerning the diagnosis is, and frankly kinda feels like lying.

            Incidentally, I find it weird that DIPG in the US seems to mean ‘anything anywhere near the brainstem’. In my world, Pilocytic Astros can’t be called DIPG- they’re focal or better circumscribed, often amenable to biopsy and even resection, and behave totally differently, as can be seen in B’s bullshit partial ‘study’.

            1. WilliamLawrenceUtridge says:

              Thank you very much for the correction and the context Missmolly, it is greatly appreciated.

        2. MadisonMD says:

          Why does Burzynski keep lying about this?

          My money is on money too.

          WLU:

          The real question for me is, why is it not easier to find out that DIPG isn’t a death sentence?

          Most physicians would be honest about the dismal prognosis with median survival <1 year, not on the miracles in <10% of cases. When Burzynski moves the goalpost to define success as 'we had someone live 5 years once,' then he fails to give an accurate depiction of the likely outcome. Most physicians won't do that.

          How many patients saw through the ugly lies after failure ANP failed? How many thousands looked at B's face, crushed with disappointment as the ugly truth revealed itself just before they were silenced by death?

        3. Brett Snodgrass, MD says:

          Dear Dr. Gorski,

          Please permit this comment to remain on your blog. You have attacked Burzynski based on his personal thinking that anti-neoplastins are just “oh so amazing.” I have limited no opinion on the matter, because they are still in a clinical trial for specifc grades of tumors.

          We do not know why Valganciclovir prolongs survival in Children with Glioblastoma Multiforme, we do not have a clinical trial on the matter. Nonetheless, it works.

          I apologize, but you remind me of one of the super brilliant people that win math contests, etc. Test high on IQ charts, etc. People like that are brilliant, but they are not always correct.

          Please permit me to elaborate. The Texas Medical Board has reprimanded Dr. Burynski with a false advertising claim, with claims of charging too much. He was administering two “new-to-market” monoclonal antibodies and they likely cost upwards of $100,000 together.”

          It is beyond me why you hate alternative medicine so much. Not only have you repeatedly alleged that antineoplastins do not work in tumors, you have done this before a single current-era clinical trial transparency blog has posted. The current era (with better trial transparency) has posted. You presume you are science based and then you maliciously attack a man who is in the middle of a clinical trial. Have you ever recrutied patients for a clinical trial? Did you identify where, in the code of federal regulations, section 21, that Dr. Burzynski violated the law?

          Please do not encourage the Texas Medical Board to file more fraudulent claims. Most high school students know that “safe and effective,” is NOT described by what the Texas Medical Board cited as “serious,” side effects, and “phase three trial needed.”

          If you hate Burnsyki and claim he is a bad guy for some other reason, then I will hear you, but I have seen how unfathomably odious medical boards can be to win their case. The Judge saw this and it is permanently documnted in United States Court Record. That the medical board knowingly and consciously attempted to deceive the judge in order to frame Dr. Adem as someone who provided bad care.

          I wish you the best as you continue to promote science. Yet the Texas Medical Board’s claim against Burynski is not science-based. It is not even based on common sense.

          Kind regards Sir,
          -BrettMD

          1. Brett Snodgrass, MD says:

            I apologize it was a clinical trial.

            http://www.ncbi.nlm.nih.gov/pubmed/23404447
            Kind regards,
            -BrettMD

            1. MadisonMD says:

              Great. But nobody is selling valganciclovir to patients based on this double blind RCT hypothesis-generating study. The authors conclude only that :

              Prolonged OS in Val>6M patients suggest that future randomized trials are warranted and should evaluate whether continuous antiviral treatment can improve outcome in glioblastoma patients.

              Now contrast this to Burzynski who hasn’t even finished a phase II much less a RCT study and yet has sold his drug to well over ten thousand desperate patients. Also the hypothesis is more plausible for valganciclovir because it is based on the concept that a virus causes the cancer and treating the virus can improve outcomes. This idea has good precedent with HIV-induced cancer, although not with HPV.

              So what you are showing, in effect, is that there is better data–an actual RCT–to treat CMV-positive GBM with valganciclovir–which is not sufficient to accept into routine practice per the researchers themselves–than with antineoplastons, which is being sold to desperate cancer patients. I don’t see how this helps your argument.

              1. Brett Snodgrass, MD says:

                Thank you for your reply.

                If Burzynski has sold ANPs to many people, than that should be what the Texas Medical Board takes Dr. Buryznski to court for.

                I am incompletely familiar and unqualified to comment on Burzynski as a good or bad; or as person that charges for an investigational drug.

                All I can comment on is what he is doing now, and what the Texas Medical Board has filed against him. The false advertising claim has nothing to do with these things that he supposedly.

                Kind regards,
                -Brett

              2. MadisonMD says:

                Hi Brett,
                Dr. Burzynski started selling ANP in the late 1970s and by 1997 was selling to 963 patients per year. He has continued to do so until, I believe last year. If there was conservatively average of 500 patients per year between 1981 and 2010 (leaving out years on the end, again conservatively), he has treated a minimum of 15,000. All were sold an unproven therapy for frightening and deadly cancer although, even today, there is no phase II trial completed– which would have only required recording and reporting objective responses in about 40 of these 15,000 patients.

                Can you please read the articles linked and comment on whether, in your opinion, Burzynski’s behavior is ethical or unethical?

              3. WilliamLawrenceUtridge says:

                Burzynski is a bad, greedy, unethical asshole. You shouldn’t be defending him in any way, shape or form. His ideas are terrible, they are not backed by science, and he’s only using the pretense of science to try to rope in more desperate and terrified patients. He doesn’t care about publishing, he only cares about enrolling and charging fat fees to new customers. His own lawyer published a book saying essentially this.

              4. MadisonMD says:

                I find Brett Snodgrass, MD rather creepy. Everytime he posts, I see dead people.

          2. WilliamLawrenceUtridge says:

            Please permit this comment to remain on your blog.

            Comments are quite supportive of free expression, as long as you are a person and not a bot, you can usually post – so you can stop pretending this is a blog that censors.

            I have limited no opinion on the matter, because they are still in a clinical trial for specifc grades of tumors.

            You might be interested to know that Burzynski’s own lawyer has said that Burzynski is abusing the clinical trial process to make money off of his customers. Search for “lawyer” in the post, then read the link.

            It is beyond me why you hate alternative medicine so much.

            I can’t speak for Dr. Gorski, but I hate it because its practitioners are terrible scientists, hypocrites who claim conflict of interest from real doctors while ignoring their own, who never acknowledge how unlikely or disproven their treatments are, who oppose helpful and proven medical interventions such as vaccination, who milk desperate patients during a time time of vulnerability, and overall are simply unethical assholes who are also clueless.

            If alt med practitioners want respect – conduct proper trials and reflect the results in practices and speech. Don’t ask for special treatment, don’t demand a chance to ride the kiddie bus of medicine. Apply a uniform standard to medical research and proof.

            Not only have you repeatedly alleged that antineoplastins do not work in tumors, you have done this before a single current-era clinical trial transparency blog has posted.

            Burzynski hasn’t published any clinical trials that I’ve known. The best he’s managed so far are the astonishingly negative subset of patients who apparently represent the best he could do.

            I would have far less of a beef with Burzynski if he actually published, but he doesn’t. He dodges, he hides, he claims conspiracy, and he unethically exploits desperate and dying patients, all to make money. He’s a horrible human being.

            Did you identify where, in the code of federal regulations, section 21, that Dr. Burzynski violated the law?

            So as long as he doesn’t violate the law, Burzynski can charge his patients tens of thousands of dollars in case fees to deliver unproven treatments and that’s OK? Wow, you have incredibly low ethical standards.

            If you hate Burnsyki and claim he is a bad guy for some other reason

            SBM has a “search” bar, and the post has categories, one of which is stanislaw burzynski. Click on it, read the links, then come back and tell us what a great guy Stan is, who totally doesn’t exploit dying patients with unproven and dangerous chemicals.

            1. Brett Snodgrass, MD says:

              Okay, I thought my prior comment was deleted, I may be mistaken, I apologize for the ambiguous, possibly misleading request.

              Kind regards,
              -Brett

    3. EL says:

      There are a small number of known survivors having no connection with Burzynski, so your initial premise is incorrect. Further, when I was looking into this clinic for my husband (GBM, deceased 2001), I noted that survival stats lumped stages together. An astrocytoma stage 2 is a different animal, and marketing drugs to those with GBM based on stats for lower stage patients is deceptive and unethical.

      The more I learned, the more I saw that this was a quack preying on the desperate and dying. I hope the TBM shuts him down.

  14. KayMarie says:

    Do we know for certain his long-term survivors actually have that brain tumor, he doesn’t seem to be that careful with some of his other patients?

    And there are reports of other patients with long term survival rates (usually seem to have an atypical features of the disease) so odds are if he saw enough of them he’d eventually get one of the atypical ones.

  15. C_TX says:

    Hello to Dr. Gorski and those Drs that post comments. I am not a doctor, I barely passed basic H.S. biology. I have an off-topic question, if someone would indulge me.

    Ahem…

    How in the holy hell do you doctors remember all this stuff? This post in particular refers to a variety of medications, by both their commercial and generic names, plus a variety of proteins/genes/cells/chemicals/statistical terms/treatment protocols/diagnostic paths and on and on and on.

    Are you smarter than me (Wait, yes you are). Do y’all have books handy to refer to this stuff.

    In other words, I’m just curious if a post like this is off the top of one’s head based on years of education and training? Or do practicing docs have a full library to refer to when they can’t remember something from freshman biology (I’ve seen the books in your office!)

    Most sincerely,
    -And awed fan of the brainiacs

    1. simba says:

      From what I’ve seen most doctors remember a lot of it, particularly the ones they come across a lot and the anatomical terms, and then keep a few books to look up for less common diseases and drugs. And, of course, brush up on the scientific papers.

    2. KayMarie says:

      Generally stuff you use day in and day out you tend to remember off the top of your head. Docs also have to do continuing education and other sorts of things to maintain their license so that helps keep things fresher than it is for people who just had high school bio then never used it again.

      I remember one professor that had all the students scared until I let them know he just spent the summer finishing up a text book on the subject so of course he had all that in his head and didn’t need his notes. There is something intimidating about someone coming in with nothing but a piece of chalk and lecturing non-stop for an hour in great detail.

      I’ve actually had a doctor pull the text off the shelf and double check something (maybe because I’m an academic so they are more willing to share process). The text was basically the diagnostic algorithms so we went over my medical tests based on the text to make sure we hadn’t missed any of the usual standard of care things. Ended up being a reaction to a medication that isn’t that common so many primary care docs wouldn’t have it in their brain (and wasn’t the kind of thing in the text we consulted), but the dermatologist had seen it often enough to recognize it.

  16. C_TX says:

    P.S.

    I forgot latin, anatomy, and just general big words.

  17. anastasia chaparro says:

    Obviously you do not have the ability for logical thought. You have taken what you want to hear only, and put it into a tight little corner of which only your cynical group of talkers and non movers or shakers reside. I suppose you think that the FDA approved drugs to combat cancer are far better than anything out there as well.
    Although you may concur with those who do nothing but provide empty rhetoric about topics on an everyday basis, you do not scare those of us whom actually “do something about it”. Your column is full of empty words and you take fiction of what the government wants you to know and regurgitate it as fact to the masses who do nothing about anything except whine when their lives are not going well. Shame on you and your little faction. Get real and be helpful for once is my advice to you. Truth hurts or makes you mad? Try truly listening for once instead of regurgitating your scatalogical breakfast of corn syrup and irradiated milk sometime.

    1. Woo Fighter says:

      You HAVE to check out Anastasia’s website. She thinks she’s a druid priestess or a witch or something. Maybe she believes she can heal cancer with her magick. If so, she has something in common with ol’ Stan.

      http://www.anastasia-chaparro.com/

      “A witch? And how do you know she is a witch?”

      “She turned me into a newt!”

      1. MadisonMD says:

        :)! That is a helluva website.

        Obviously a druid priestess trumps all in logical thought:

        save a tree, save a faerie, love a crystal, love the arth

        Old Stan should be proud of his critical and incisive supporters.

    2. WilliamLawrenceUtridge says:

      I suppose you think that the FDA approved drugs to combat cancer are far better than anything out there as well.

      Yes. Compared to unproven drugs in general, FDA-approved drugs have actually been tested. Compared to Burzynski’s piss extracts, they’re even better – the piss extracts have been identified as “phenylacetic acid” and “3-N-phenylacetylamino piperidine 2,6-dione“, which are already part of normal metabolism. If they prevented or treated cancer, well, nobody would get cancer because we already produce both.

      Your column is full of empty words and you take fiction of what the government wants you to know and regurgitate it as fact to the masses who do nothing about anything except whine when their lives are not going well.

      It may appear that way when you don’t understand any of the words, but trust me – they mean something. Perhaps if you read a book on anatomy and physiology, you might start the process to understand why Dr. Gorski’s criticisms are damning and Burzynski’s claims are nonsense.

      Get real and be helpful for once is my advice to you.

      Read a book is mine to you. The Emperor of all Maladies is a good start.

      ry truly listening for once instead of regurgitating your scatalogical breakfast of corn syrup and irradiated milk sometime.

      That’s hilarious advice coming from someone who just posted your little content-free comment. And for breakfast today I had whole wheat bread and fruit. Most days I have a mixture of flax seed and yogurt, thanks.

  18. MadisonMD says:

    Obviously you do not have the ability for logical thought.

    To whom do you direct this ad hominem and what evidence do you offer for this conclusion?

    I suppose you think that the FDA approved drugs to combat cancer are far better than anything out there as well.

    No, probably not. There are probably a host of better things out there that are not yet found. Until then, it is best to use treatments that are rigorously proven to be effective rather than guessing at the effectiveness of urine extracts derived from a failed 1970′s era hypothesis.

    Shame on you and your little faction. Get real and be helpful for once is my advice to you. Truth hurts or makes you mad? Try truly listening for once instead of regurgitating your scatalogical breakfast of corn syrup and irradiated milk sometime.

    The only thing I can derive from this screed is that you do not have any facts, evidence or reasoning to offer. Is it extreme anger that drives you to type such incomprehensible evidence-free text?

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