Respectful Insolence

I was very pleased last Friday, very pleased indeed. Given the normal subject matter of this blog, in which we face a seemingly unrelenting infiltration of pseudoscience and quackery into even the most hallowed halls of academic medicine, against which we seem to be fighting a mostly losing battle, having an opportunity to see such an excellent deconstruction of bad science and bad medicine in a large mainstream news outlet like USA TODAY is rare and gratifying. As you might recall, USA TODAY reporter Liz Szabo capped off a months-long investigation of Dr. Stanislaw Burzynski and his Burzynski Clinic with an excellent (and surprisingly long and detailed) report, complete with sidebars explaining why cancer experts don’t think that Burzysnki’s anecdotes are compelling evidence that his treatment, antineoplastons, has significant anticancer activity and a human interest story about patients whom Burzynski took to the cleaners. Most of this, of course, is new news to my readers, as I’ve been writing about Dr. Burzynski on a fairly regular basis for over two years now. It’s just amazing to see it all boiled down into three articles and ten short videos in the way that Szabo and USA TODAY did, to be read by millions, instead of the thousands who read this blog. Szabo also found out who the child was who died of hypernatremia due to antineoplastons in June 2012, a death that precipitated the partial clinical hold on Burzynski’s bogus clinical trials, about which both Liz Szabo and I have quoted Burzynski’s own lawyer, Richard Jaffe, from his memoir, first about Burzynski’s “wastebasket” trial, CAN-1.

Naturally, upon reading Liz Szabo’s story, I wondered how long it would be before there would be a response from Stanislaw Burzynski or his minions. It turns out that Burzynski actually responded to the FDA findings before the story ran, but over the weekend, everyone’s favorite Burzynski propagandist Eric Merola wasted no time losing his mind over the savaging of his heroic brave maverick doctor.

The Burzynski shills strike back

My original plan for today had been to look into the story in a bit more detail than I had time for on Friday, in particular addressing the Burzynski Clinic’s response to the original FDA report in more depth and looking at some historical context. I figured that the Burzynski Clinic would strike back at some point, but it hasn’t yet, not really. Instead, it’s unleashed its resident propagandist and attack chihuahua Eric Merola, the man who wrote and directed two “documentaries” about Burzynski that were such propaganda about the “great man” that they’d make Leni Riefenstahl blush. Merola rapidly posted on his own website an open letter to Liz Szabo and then turned around and went full Godwin on her at his movie’s website. His responses are remarkable for their intensity; so I’ll briefly deal with them before I get into the “meat” of this post. His first response, which made the rounds within a few hours after Szabo’s story appeared, was his open letter/e-mail to Szabo. His second response appeared on the website for his movies and was entitled Dear Burzynski Movie Subscribers.

Both responses contain the same sorts of tropes, misinformation, and pseudoscience that we’ve come to expect from Merola: USA TODAY is biased and in the pocket of big pharma. It was a “hit piece.” Burzynski is so far ahead of his time and will be vindicated (i.e., the Galileo gambit). It’s not just Burzynski, but the Japanese, who have “proven” that antineoplaston’s work. I’ve deconstructed these, and many more, of Merola’s nonsense over the last two years. What actually surprised me was the viciousness of the counterattack. For example, in his letter to Liz Szabo, he actually hopes that her child will get cancer, so that Burzynski supporters can gloat about it and Szabo will have to apologize to her children for her “perfidy” (in Merola’s eyes, at least):

Burzynski has found a life-saving cure for many cancers. You have just aided in helping to destroy that. I feel for you if your children get diagnosed with a pediatric brain tumor. You can look them in the eye and tell them “I’m sorry, I helped destroy the only thing that could have helped you.”

Such a nice guy. He denies that he hopes Szabo’s children will develop brain cancer, but then gloats gleefully over the possibility that she would have to face them after having—again in his mind—”helped to destroy the only thing that could have helped” them. In the dictionary, under the definition of “despicable,” there should be a picture of Eric Merola. Then, just when I thought Merola couldn’t go any lower, he does, this time in his longer response on his movie website:

Trying to “debunk” USA TODAY’s diatribe on Nov. 15, 2013 would be like someone living in Nazi Germany trying to debunk the writings of Joseph Goebbels, or an African American trying to explain to his slave master that he too is also a human being with rights and emotions, or the parents of an American soldier trying to explain to members of the Westboro Church how disrespectful it is to hold up signs that read “God Hates Fags” during their child’s funeral.

This type of unbridled hate and bigotry goes far too deep for any rational human discourse.

Obviously, to Merola asking Burzynski to follow normal rules regulating medical ethics and human subject protections in clinical trials is exactly like murdering millions of people, carrying out horrible medical experimentation, making untold numbers of Africans slaves, and harassing grieving families of soldiers killed in battle. My first thought on reading this is that it’s rare to see an article in which someone “goes Godwin” so quickly and so despicably. It’s only the third sentence, fer cryin’ out loud! Didn’t anyone ever teach Merola that you need to build up to that sort of climax?

It’s also one reason that I don’t have any compunction about comparing Merola to Leni Riefenstahl. Of course, the big difference between Leni Riefenstahl, unfortunately, is that she had talent, and Eric Merola does not. Just watch his movies—if you can stand the robotic narration, the choppy editing, and the cheesy graphics—if you don’t believe me. However, the intensity of the imaged used by Merola do demonstrate the intensity of the hate he bears for critics of his hero Stanislaw Burzynski. To Merola, we are Nazis, slave owners, and bigoted religious fanatics. This explains quite well why he decided to attack us so viciously and clownishly in his most recent movie. At the time, I described it as almost Monty Pythonesque, except that Monty Python were brilliant and produced such effects on purpose. Merola is a hack and is only funny by accident because he has no filters that tell him when he’s going way over the top. To him, we are infidels. We do not share his belief, but, even worse, we have the temerity to criticize his god, or, to mix metaphors shamelessly, to point out that his emperor has no clothes.

Since I’ve dealt with so many of the tropes included in Merola’s not-so-little rant, I hardly see the need to repeat myself. However, as a cancer surgeon, I find one of Merola’s lies to be as despicable, or perhaps more so, than his Nazi/slavery/Westboro Baptist Church comparisons. In essence, he denies the toxicity of antineoplastons in terms I’ve never seen anyone try to downplay before:

ANP… is toxic?

This was perhaps the most stunningly malicious use of emotion to manipulate the reader in any of the propaganda pieces against ANP in history. Never mind that tens of thousands of people die from complications from approved and properly prescribed pharmaceutical drugs per year—being one of the leading causes of death in the USA. Never mind that the average Stage IV cancer patient dies from complications due to chemotherapy and radiation before the disease has a chance to kill the patient. USA TODAY will have you believe that “sleeping in excess” a little bit while under ANP is a dangerous and toxic side effect of the therapy.

Never mind that not one single cancer patient in the history of ANP’s existence has ever died from the therapy.

Ever.

Tell that to the parents of Josia Cotto. Josia, as readers of Liz Szabo’s report will know, was the six year old boy with an inoperable brain tumor who died of hypernatremia (elevated sodium levels in the blood) as a result of Burzynski’s therapy. As I pointed out last Friday and Szabo reported in her story, before his death Josia’s serum sodium was measured at 205 mEq/L, way above the normal range of 136-145 mEq/L and well into the lethal range. As I pointed out then, I’ve never seen a sodium level anywhere near that high. During my residency, the highest I recall ever seeing was maybe around 180 mEq/L. As for Merola’s swipe about “sleeping in excess” as a toxicity, it’s rare for someone (but not Merola) to reveal such ignorance in a single sentence. Lethargy and somnolence can be symptoms of hypernatremia, and are often followed soon after by seizures. They can also be symptoms of the tumor progressing. Absolutely they are adverse events. Truly, Merola’s ignorance of what is and isn’t considered and adverse event and why it’s important to report all adverse events in clinical trials approaches black hole levels, from which no scientific knowledge can escape.

Of course, none of this is new information. A Cancer Letter article from 1998 pointed out that investigators had observed “severe toxicity” in 33% of patients that necessitated stopping treatment. One of those patients experienced—yes—somnolence before developing seizures. I also note that one of Burzynski’s most famous patients, Hannah Bradley, who with her partner Pete Cohen proclaims herself cured of her brain cancer, thanks to Burzynski, suffered some pretty serious toxicities from antineoplastons herself, including high fevers to 103.9° F, shaking chills, and severe rashes. Pete even documented how badly Hannah reacted to antineoplastons in his YouTube documentary Hannah’s Anecdote.

The rest of Merola’s rant reads like a greatest hits compilation from cancer quacks. The system is corrupt. Oncologists know chemotherapy doesn’t work and only administer it to make money. The FDA is fascist. You get the picture. That’s the wingnut counteroffensive against Liz Szabo’s article. Now let’s see how Burzynski, knowing that Szabo’s story would be published soon, tried to pre-empt the FDA findings that I described in detail last week.

Burzynski tries to defend himself

Before I discuss why Burzynski’s explanations don’t excuse his activities, I can’t help but point out that I find it rather curious that the FDA released the two FDA Form 483′s describing what its investigators found at the Burzynski Clinic during their investigations from January to March 2013. To be honest, as I mentioned before, the biggest disappointment that I had over Szabo’s excellent reporting is that she apparently couldn’t get to the bottom of why the FDA has let Burzynski continue to run his dubious clinical trials for so long, despite multiple investigations over the preceding decade that had found deficiencies in his operation, particularly in how his institutional review board (IRB) works. (An IRB is a required committee that each institution doing human subjects research must have to approve and monitor human subjects research and ensure that it meets Office for Human Research Protections (OHRP) requirements.) Given that the USA TODAY story makes the FDA look very, very bad indeed—and more than justifiably so—it strikes me as more than a tad coincidental that the FDA finally released these preliminary reports a mere week before Szabo’s story was published, eight months after its investigation concluded. It’s almost as though the FDA were trying to cover its exposed posterior. One can only hope that Szabo’s story lights a fire under that same posterior to actually do something more about Burzynski, such as making the clinical hold permanent and banning him from ever doing any further clinical trials.

Be that as it may, let’s recap what the FDA found, summarized by yours truly. The findings came in two reports. The first set consisted of the first Form 483 and a warning letter issued by the FDA in late September:

  1. The IRB failed to follow FDA regulations regarding expedited review procedures [21 CFR 56.110(b)].
  2. The IRB approved research without determining that the following criteria were met: risks to subjects were minimized [21 CFR 56.111(a)(1)]; risks to subjects were reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be expected to result [21 CFR 56.111(a)(2)].
  3. The IRB failed to determine at the time of initial review that studies involving children are in compliance with 21 CFR part 50, subpart D, Additional Safeguards for Children in Clinical Investigations [21 CFR 56.109(h)]. This is a repeat violation from our 2010 inspection.
  4. The IRB failed to prepare, maintain, and follow written procedures and maintain adequate documentation governing the functions and operations of the IRB [21 CFR 56.108(a), 21 CFR 56.108(b), and 21 CFR 56.115(a)(6)].

As I discussed before, this is a massive failure of the Burzynski Research Institute (BRI) IRB. It is, in essence, the abuse of a process designed to allow minor changes to clinical trial protocols to be approved by an IRB without a full meeting of the IRB for a purpose for which the expedited approval process was never intended: to approve single-patient protocols, which are, in essence compassionate use exemptions that allow patients who normally wouldn’t meet the inclusion criteria of the trial to receive the experimental therapy. Such protocols require full meetings of the IRB to discuss. Of course, such abuses are not surprising, given that the BRI IRB is run by an old crony of Burzynski’s from his Baylor days, Charlton F. Hazlewood. There’s very little in the way of a response that Burzynski could make to these allegations and be convincing. OHRP rules on single patient protocols are not unclear:

A “single patient use” allows a physician to obtain access to an investigational drug for the treatment of a single patient. Usually, the patient is in a desperate situation and unresponsive to other therapies, or in a situation where no approved or generally recognized treatment is available. Further, there is usually little evidence that the proposed therapy is useful, but may be plausible on theoretical grounds or anecdotes of success. Access to investigational drugs for use by a single, identified patient may be gained either through the sponsor under a treatment protocol, or through the FDA, by first obtaining the drug from the sponsor, and then submitting a treatment IND to the FDA requesting authorization to use the investigational drug for treatment use [21 CFR 312.35].

There are situations when it is allowed to do single patient protocols without getting IRB approval first, but they are very uncommon:

First, the FDA human subjects regulations allow for a test article to be used in emergency situations without prior IRB approval provided that the emergency use is reported to the IRB within five working days; subsequent use of the test article must be reviewed by the IRB [21 CFR 56.104]. An emergency is defined as a life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval [21 CFR 56.102(d)]. [See Guidebook Chapter 2, Section B, "Food and Drug Administration Regulations and Policies."]

In other words, IRB approval is required before single patient use of investigational agents. This presentation confirms that. Indeed, it is listed as an impediment to single patient protocols because of the time and expense of convening a full IRB meeting for a single patient. Indeed, expedited review, the very same process that the BRI IRB used to approve single patient protocols, is listed as a potential solution to the difficulties in getting single patient protocols approved. Of course, that means that currently expedited review is not permitted as a method for an IRB to approve a single patient protocol. Oddly enough, there’s not much in the Burzynski Clinic response about single patient protocols.

The second set came from the second Form 483, which listed these deficiencies:

a. …For 18 of 27 (67%) of subjects, the investigator did not comply with the protocol requirements for assessing the efficacy endpoint of tumor response and recorded inaccurate assessments for tumor response in study records. For example:

  • Study [REDACTED]: Subjects 005297 and 007197 were inaccurately classified as Complete Response (CR). Subjects 004721 and 008765 were inaccurately classified as Partial Response (PR). Subjects 005974, 011373, 012184, 012206, and 12252 were inaccurately classified as Stable Disease (SD).
  • Study [REDACTED]: Subjects 06389, 11819, and 13660 were inaccurately classified as CR. Subjects 21428 and 23399 were inaccurately classified as PR.
  • Study [REDACTED]: Subject 009990 was inaccurately classified as CR. Subject 004881 was inaccurately classified as PR.
  • Study [REDACTED]: Subject 006239 was inaccurately classified as PR. Subject 004240 was inaccurately classified as SD.

b. You did not have a QA monitor properly monitor CRFs [case report forms] and subject records. The investigator destroyed critical subject case history records (target tumor measurement worksheets) or misplaced case history records (original subject CRFs) for all subjects.

There were several others, so many that I could do a series of posts about them, but these two stand out to me most of all:

  • Your MRI tumor measurements initially recorded at baseline and on-treatment MRI studies for all study subjects were destroyed and are not available for FDA inspectional review.
  • You failed to monitor as required by Section 16 of your Monitoring Plan. The investigator did not report adverse events (AEs) experienced by study subjects, including 18 cases of hypernatremia.

Let’s deal with what I view to be the worst of the worst, namely Burzynski’s apparent inability to accurately assess whether a patient is experiencing a complete response (CR) to therapy, a partial response (PR), stable disease (SD), or progressive disease (PD), terms that are fairly self-evident but that I defined in depth last time around. So how did Burzynski dance around the issue? He did it in a number of ways, because there were a number of reasons why individual patients were thought to have been misclassified. For example, the FDA notes:

Subject 23643 : The study protocol required the subject to be off chemotherapy for at least 4 weeks. The cbemotherapy on 7-17-12 and began treatment with the investigational product, one day later, on 7-18-12.

And indeed, the protocol did require:

At least eight weeks must have elapsed since the last dose of radiation therapy and at least four weeks must have elapsed since the last dose of chemotherapy (six weeks for nitrosoureas) or immunotherapy.

Since the full effectiveness of initial therapy including radiation therapy) may not be seen until a few months after the initial therapy is completed it is very difficult to analyze the effectiveness of initial therapy before the patient has completed treatment and follow-up. Because of this treatment decisions are usualty not made on the base of radiological studies performed earlier than four weeks following completion of radiation therapy.

The only exception is:

However, patients with clear evidence of disease progression during the initial therapy may be enrolled less than (8) eight weeks following the last dose of radiation therapy, less than 4 weeks after surgery or the last dose of chemotherapy. if the investigator has determined that it is safe to administer antineoplastons to such patients.

I mentioned, but did not explain, the phenomenon of “pseudoprogression,” because I was impressed with how well Szabo had explained it in her story. Pseudoprogression can confound treatment decisions regarding second line therapy after initial treatment, being basically a phenomenon in which late effects of radiation therapy can produce enhancing lesions that look all the world on MRI like tumor recurrence. There was a nice review of this topic a few years ago that describes the phenomenon. I referenced it in my discussion of pseudoprogression in the context of discussing another patient with brain cancer not cared for by Burzynski. As a reminder, I will quote the USA TODAY article again, because it is the most succinct explanation of pseudoprogression I have ever seen and therefore worth quoting one more time:

Many of Burzynski’s patients are terminally ill and have had one or more previous types of conventional cancer care — surgery, radiation or chemotherapy — before they see him.

But these therapies may have delayed benefits, taking weeks or months to shrink a tumor. So patients treated by Burzynski may credit him for their progress, just because he was the last doctor to treat them, says Peter Adamson, chair of the Children’s Oncology Group, an NCI-supported research network that conducts clinical trials in pediatric cancer.

Conventional cancer treatment can also cause tumors to swell temporarily, due to inflammation. A patient who isn’t familiar with this phenomenon may assume her tumor is growing. When that swelling subsides, patients may assume it’s because of Burzynski, Adamson says. In reality, the tumor was just returning to its previous size.

To avoid such confusions, researchers typically require patients to wait before starting a new treatment, Adamson says.

In other words, in a small but not inconsequential number of cases (perhaps as much as 28%, as I discussed before), apparent tumor progression really isn’t. That’s why it’s called pseudoprogression, and is defined as the delayed but still early effects of therapy mimicking tumor recurrence on MRI scans. In other words, therapy of brain tumors can result in the enhancement seen on MRI associated with the tumor to increase in size due to increased blood flow due to inflammation. The same phenomenon is very likely true for many Burzynski patients who are presented as “success stories.” They show pseudoprogression, and, as pseudoprogression does, the “enlarging cancer” decreases in size after the patient is put on antineoplastons. However, the decrease has nothing to do with the therapy. That’s why in Burzynski’s case well-conducted clinical trials are absolutely essential, as well as why clinical trials require patients to be off therapy from 4-8 weeks to avoid the confounding effects of pesudoprogression. Of course, the number of patients exhibiting pseudoprogression who don’t ultimately develop a real recurrence that kills them is much, much smaller, but not so small that it can’t explain many of Burzynski’s testimonials. In fact, I bet pseudoprogression in patients who were lucky enough to be cured or have had their tumors shrunk enough that it takes a long time to recur probably explains the majority of Burzynski’s brain cancer testimonials.

Another big issue that the FDA noted was that some of the patients whose tumor responses to antineoplastons had been overestimated by Burzynski were still on steroids. Steroids are often administered to brain cancer patients to lessen the edema (swelling) that frequently occurs around tumors. Given that the skull is a fixed volume, any swelling can result in increased intracranial pressure, which can damage the remaining brain. The problem here is that if Burzynski’s patients were on steroids, it could make the tumors appear smaller than they really are. Burzynski started out his excuse with some obfuscation that the guidelines for determining CRs have changed twice over the last several years. Well, yes, that’s true. As referenced by Burzynski, the Macdonald criteria for response assessment were changed in 2010 to incorporate changes in steroid doses as part of the definition of responses. For a response to be assessed as a CR or PR, the patient now has to be on stable or decreasing steroid doses. Burzynski tries to justify some of the patients this way:

Our definition ofa “patient off corticosteroids” is one who continues on the lowest dosage necessary for neurologic stability and is maintained at their level of comfort and function. This is ordinarily determined by decreasing the close until signs increase or become apparent and then increasing the dose until they subside. If deterioration is secondary to tumor growth or treatment–induced effects, the glucocorticoids dose may have to be increased to keep the patient comfortable. Hence, “off corticosteroids” in order to interpret response to treatment is defined as a patient that may either be off steroids or be receiving a stable steroid dose to maintain neurologic and physiologic stability.

Since the beginning of Phase ii study program under IND 43,742, the criteria used for assessing response to therapy in malignant brain tumors have changed twice. The most recent recommendations of the Response Assessment from the Neuro-Oncology Working Group became active in April, 2010. According to these recommendations, it has been accepted that complete and partial responses can be determined when the patient is on physiologic replacement doses of corticosteroids.

All of which is true, but irrelevant. Response criteria can’t be changed mid-stream in a clinical trial without actually altering the clinical trial. If the standard methodology of measuring tumor response changed, then if an investigator wants to use those changes he has to submit an amendment to his protocol to his IRB and the FDA and get it approved. Clearly, Burzynski didn’t do that, and according to his protocol the patient had to be off steroids. So the FDA called him on it.

Some of Burzysnki’s other excuses are ludicrous in the extreme, and I’ll deal with some of them briefly. For example, for one patient, Burzynski writes:

Patient 004240: An assessment of SD was determined based on the size of the
enhancing lesion and does not reflect the overall increase of tumor size due to
formation of a Cyst. The change in the overall size ofthe brainstem lesion on
studies between 2/21′/96 and 5/22/96 is due to an increase (4/10/96) and
collapse (5/22/96) of the cystic component of the lesion.

No, you don’t get to estimate tumor volumes that way, particularly back in 1996. It rather reminds me of the way Burzynski has played fast and loose calling responses when tumors get larger based on seeing increasing size of “cysts,” the way he did with Amelia Saunders.

For another patient, he seems to want to have it both ways:

Patient 005974: The enhancing portion of the tumor increased 30%, which met the criteria of SD using previously used criteria. Since we are amending the protocol, this patient will be reclassified as PD.

In other words, when I the old criteria don’t make me declare a patient as having PD, I use them. When they would force me not to call a CR or PR but the new criteria will, I use the new criteria. Again, you can’t flip back and forth between new and old criteria, picking whichever set of criteria gives you the better results. You have to pick one and stick with it for every subject on the trial. It’s acceptable to change to the updated criteria, but if as a principal investigator you choose to do that then you need to go back and reassess response for every single subject on your trial from day one using the new criteria.

I could go on and on, but even I get tired after a while. However, I can’t finish without looking at one claim that Burzynski made as an excuse that almost cost me a keyboard as I was drinking coffee as I read it. Perhaps the most damning finding of the FDA was the Burzynski Clinic’s failure to keep original scans and records on some patients. Here is the Burzynski Clinic’s excuse:

ICH E6, section 1.51, also defines source data as “All information in original records and ‘certified’ copies of .original records or clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.”

The clinic notes contained copied source data oftumor measurements that had been verified, dated and signed, which from our interpretation would constitute being a “certified copy” of the data. We judged that the data of tumor measurements were accurate and could be audited back to the source document.

A5 for the issue of misplaced case history records original subject CRFS), we maintain that these original CRFs were populated with data that was derived from the patient case files and would not be considered original source data. The source data are the patient files. Back in the year 2000, BRI regulatory and clinical staff determined that the “original were considered inadequate and required redesigning in that they had a number of missing fields. As was done for the “original new CRFS were again generated from the source data in the case history records and not derived from the original CRFs. These “new are available for review. We retained a total of 132 of the “‘original which have been located in our archives. However, we do not plan to use these, based on the aforementioned reasons as well as not being source documents. The remaining ‘original which were not signed offon as true and accurate copies of source data were destroyed for the reason of being incomplete.

No, “certified” does not mean “copied onto new forms or into new computer database fields because we redesigned our forms.” Certified copies tend to be copies of medical records from other institutions used in the conduct of clinical trials; i.e., certified medical records such as any patient can request from a health care provider, as in photocopies of clinical records, copies of scans, or CDs or DVDs containing radiology tests. For a clinical trial, there is no excuse for destroying original documents from your own clinic used for a clinical trial. None. Ever. At least not without FDA and IRB approval before doing so. The reasons are obvious. It destroys the very paper trail that is critical to the trustworthy conduct of a clinical trial. Destroying such records indicates either gross incompetence or an investigator trying to hide something. This suspicion becomes particularly pertinent given that many of the original MRI scans of Burzynski patients appear to be missing, making it impossible for the FDA to do repeat measurements, in order to determine whether Burzynski’s response assessments were correct.

There are multiple other examples of dubious claims in Burzynski’s response, but I’ve mostly covered them in my original post on the FDA revelations. These include the hypernatremia cases that Eric Merola basically denied, which Burzynski tried to brush off due to changes in the Common Terminology Criteria for Adverse Events (CTCAE) over the years. In essence, he claimed that hypernatremia wasn’t listed on the earlier version of CTCAE; so he made up “clinical severity” criteria, which didn’t agree with the CTCAE. Now, the CTCAE has been around since 1983, although it was called the Common Toxicity Criteria until v.3 in 2003. Each version has added more criteria. Before 2003, Burzynski might have had a point; I can’t find whether CTC v.1 (1983 to 1996) or CTC v.2 (1996 to 2003) listed hypernatremia, but any time after 2003, he’s undoubtedly full of bovine feces, as CTCAE v.3.0 does list hypernatremia, as does CTCAE v.4.0.

Isn’t this enough?

I’ve written time and time again about what I call the central mysteries of the Burzynski saga. The first mystery is why the Texas Medical Board hasn’t been able to shut him down, despite over 30 years of trying. That’s the easier mystery to explain. The Texas Medical Board is a paper tiger, intentionally weak to protect doctors’ business interests. The second central mystery is why the FDA has let Burzynski get away with so many violations with respect to clinical trials. We know why he was allowed to register those clinical trials in the first place. Political pressure on the FDA from U.S. Representative Joe Barton and other woo-loving heavy hitters in the 1990s saw to his being able to register 72 phase 2 clinical trials, but what’s allowed those trials to remain registered, and why on earth did the FDA ever approve Burzynski’s one and only phase 3 clinical trial back in 2009, a trial that never accrued a single patient before closing?

The great thing about the USA TODAY story is that it is likely to be the most widely read detailed story about Burzynski ever published, given how large the circulation of USA TODAY is, and it was a front-page story. As good as it was, it doesn’t have all the answers. The first step is shutting Burzynski down, but that’s not enough. We need to know what’s wrong with the FDA that allowed Burzynski (mostly) free rein for so many years, and we need to fix it.

Comments

  1. #1 Yerushalmi
    November 18, 2013

    I liked the “sleeping in excess” excuse. I suppose from a certain point of view, Merola would probably claim that Josia Cotto is “sleeping in excess” right now.

  2. […] Eric Merola and Stanislaw Burzynski respond to the FDA findings and the USA TODAY story. Hilarity en… Orac, Respectful Insolence, 18/11/13 […]

  3. #3 Ren
    November 18, 2013

    One of Merola’s big complaints was that, allegedly, journals won’t publish Burzynski’s papers because he’s been tainted, or there is a vast pharma conspiracy or something. Then why not put it up on his own? Let the peer review be by all of us? We know he has a lot to hide. He claims he doesn’t. Prove us wrong.

  4. #4 Eric Lund
    November 18, 2013

    Ren @2: I’m not aware of anything in biomedical science comparable to the arXiv in physics, so in order to publish his stuff, Burzynski has to go to the journals. I would assume (but don’t actually know) that most if not all reputable biomedical journals would ask inconvenient questions like, “Were the protocols approved by an IRB that isn’t riddled with conflicts of interest?” Of course there are scam OA journals which would be eager to publish his work, but being a scammer himself (it takes a thief…), Burzynski probably realizes that these journals are scams.

    I’m not sure whether it’s coincidence or irony that IRB backwards is BRI.

  5. #6 Calli Arcale
    November 18, 2013

    “USA TODAY will have you believe that “sleeping in excess” a little bit while under ANP is a dangerous and toxic side effect of the therapy.”

    Huh. And here I’ve always been told that if my child sleeps too much, I need to call the doctor right away, because of how very many extremely bad things start out with that.

    Merola is a tool, in every possible sense of the word. Burzynski . . . well, the word I want to use for him is unprintable.

  6. #7 Todd W.
    http://www.harpocratesspeaks.com
    November 18, 2013

    @Eric Lund

    I think what Ren is referring to is, why doesn’t he just put together a paper and put it up online, say, on his web site? Let the world freely read and judge his research.

  7. #8 Ren
    November 18, 2013

    As usual, Todd reads my mind… Or reads between my lines. Or something.

    Look, I haven’t had coffee and I’m a grad student again. My English is lacking.

  8. #9 Todd W.
    http://www.harpocratesspeaks.com
    November 18, 2013

    @Ren

    I have a degree in Grad Student to English translation. That, or we share a hivemind.

  9. #10 Shay
    flat but undamaged central Illinois (at least my part of it)
    November 18, 2013

    Isn’t there some kind of regulatory oversight on IRB’s? How does Stan’s manage to keep functioning?

    I helped the epi students at our local nursing school set up a research project on flu vaccine uptake, and when I think of the hoops we had to jump through with the University’s IRB….

  10. #11 AdamG
    November 18, 2013

    I’m not aware of anything in biomedical science comparable to the arXiv in physics

    http://biorxiv.org/ lives! Although I highly, highly doubt any of Burzy’s papers would pass the screening process.

  11. #12 lkr
    November 18, 2013

    Journals would also have a problem with an author who routinely destroys lab images, data, notebooks

  12. #13 Narad
    November 18, 2013

    http://biorxiv.org/ lives!

    I’d spend some time complaining about the chi in the logo if I didn’t have to be out the door two minutes ago.

  13. #14 Michael
    http://www.skepticalraptor.com/skepticalraptorblog.php
    November 18, 2013

    Someone needs to arrest this charlatan. And since Mr. Andy Wakefield is down there too, maybe the jackbooted Black Ops police can sweep him up too.

  14. #15 DLC
    November 18, 2013

    Is Bursinski just a con artist or does he suffer from Dunning-Kruger effect ? Well, the two are not mutually exclusive.

  15. #16 Eric Lund
    November 18, 2013

    Isn’t there some kind of regulatory oversight on IRB’s?

    That’s what the FDA is supposed to be doing here, but aren’t (at least not in an effective manner).

    It makes me wonder whether one of BRI’s research activities has involved obtaining photographs of FDA inspectors in compromising positions. (That kind of research does not require IRB approval, but there may be other relevant statutes.) There are other ways to explain the FDA’s need to release those forms as a CYA exercise, but all of them make them or BRI or both look bad.

  16. #17 Chico
    Shaking with Cold Fury
    November 18, 2013

    On behalf of all canines known as “Chihuahua”, I must vehemently protest your use of our breed name in referring to that Merola human. Donkeys and hyenas are certainly deserving of derision but clearly the noble breed of Chihuahua does not merit this flagrant disrespect.

    I “respectfully” ask that you cease and desist in defaming our fine and loyal Chihuahua brethren by associating us with evil huckster-frauds.

    Your friend, Chico

  17. #18 lilady
    November 18, 2013

    Could 3 poster presentations by Stan and his crew in San Francisco at The World Federation of Neuro-Oncology on November 22, 2013, be used in lieu of publishing his
    brain tumor treatment trials in a medical journal?

    https://soc-neuro-onc.conference-services.net/programme.asp?conferenceID=3676&action=prog_categories

    A Phase II study of antineoplastons A10 and AS2-1 (ANP) in children with high-grade glioma(Protocol BT-06)
    Tomasz Janicki*, Stanislaw Burzynski, Gregory Burzynski, Ania Marszalek
    Friday, November 22, Scientific Meeting: Poster session – 7pm – 9:00pm

    NO-058

    A Phase II study of antineoplastons A10 and AS2-1 (ANP) in children with high-grade glioma(Protocol BT-06)

    Tomasz Janicki 1 ,2, Stanislaw Burzynski1 ,2, Gregory Burzynski1 ,2, Ania Marszalek1
    1Burzynski Clinic, Houston, TX, USA, 2Burzynski Research Institute, Houston, TX, USA

    There are no standard treatment recommendations for patients with high grade glioma after recurrence. New therapies are required for patients whose tumor recurs after first-line treatment. This single-arm, two stage, interventional Phase II study evaluated the efficacy and safety of ANP in children with high grade glioma. All patients had failed standard therapy including surgery, radiation, and chemotherapy. Nineteen patients were enrolled in the study (safety population) and twelve patients with a median age of 9.7 years, ranging in age from 1 to 17.5 years, who met eligibility criteria, were evaluated. The majority of subjects (11/12) were Caucasian and 7 (58%) were female. Half of the patients were diagnosed with glioblastoma, 42% with anaplastic astrocytoma, and one with rhabdoid tumor. Previous treatment included surgery in all patients (8 had tumor resection, and the 4 underwent biopsy only), chemotherapy in all patients and radiation therapy in 10 patients. At least 8 weeks elapsed between initiation on ANP and previous radiation and 6 weeks for chemotherapy with nitrosoureas. Antineoplastons were administered intravenously every four hours (median dose of A10 10.7 g/kg/d and AS2-1 0.43 g/kg/d) until objective response was documented or until progression. The median duration of antineoplastons treatment was 31.7 weeks (range 11 to 120 weeks). Responses were assessed by gadolinium-enhanced MRI repeated every 8 weeks. A complete response and partial response was documented in 4/12 (33%), stable disease in 3/12 (25%). Progression free survival at six months was 58% and overall survival at one year was 46%. One patient (8%) is still alive, 8 years post-treatment. All Grade 3 and 4 toxicities (two hypernatremia’s and one decrease of neutrophils) were reversible. There were no chronic toxicities. It is concluded that antineoplastons show efficacy with an acceptable profile in this cohort of patients with recurrent high-grade glioma.

    A Phase II study of antineoplastons A10 and AS2-1 in adult patients with recurrent glioblastoma multiforme based on Protocol BT-21
    Gregory Burzynski*, Stanislaw Burzynski, Tomek Janicki, Ania Marszalek
    Friday, November 22, Scientific Meeting: Poster session – 7pm – 9:00pm

    NO-020

    A Phase II study of antineoplastons A10 and AS2-1 in adult patients with recurrent glioblastoma multiforme based on Protocol BT-21

    Gregory Burzynski 1 ,2, Stanislaw Burzynski1 ,2, Tomek Janicki1 ,2, Ania Marszalek1
    1Burzynski Clinic, Houston, TX, USA, 2Burzynski Research Institute, Houston, TX, USA

    Treatment of recurrent glioblastoma multiforme (GBM) creates one of the most difficult challanges in neuro-oncology. The aim of this presentation is to evaluate the responses and survival of 24 recurrent GBM patients and toxicity in all 33 eligible patients. The study accrued patients who developed disease progression during standard treatment within eight weeks from completion of radiation therapy (RT) and six weeks from chemotherapy. Forty candidates were registered but only 33 patients were eligible. The seven noneligible patients received less than 28 days of treatment with Antineoplastons A10 and AS2-1. Among the eligible patients there were 24 cases of recurrent GBM that progressed during prior treatment, four patients with anaplastic astrocytoma and five persistent GBM. Previous treatment included surgery in all patients (18 had tumor resection, and 6 underwent biopsy only), chemotherapy in 75% of patients and radiation therapy in 88% of patients. Antineoplastons were administered intravenously every four hours (median dose of A10 10.7 g/kg/d and AS2-1 0.43 g/kg/d) until objective response was documented or until progression. The median duration of ANP treatment was 13.2 weeks ranging (4.6 – 80.3). Responses were assessed by MRI repeated every eight weeks, and or PET scan. Objective responses were determined in 16.7% of cases (complete response, and partial response in 8.3% each). Progression-free survival at six months was 25%. Overall survival is 39.3% at one year, 4.4% at two years, five and ten years. The treatment was well tolerated with reversible grades 3 and 4 toxicity including four cases of hypernatremia, two of fatigue, two of hypokalemia, and a single case of somnolence. There were no chronic toxicities. In conclusion, ANP is well tolerated and compares favorably to the current treatment for recurrent GBM.

    A Phase II study of antineoplastons A10 and AS2-1 in pediatric recurrent diffuse intrinsic pontine glioma
    Stanislaw Burzynski*, Tomasz Janicki, Gregory Burzynski, Ania Marszalek
    Friday, November 22, Scientific Meeting: Poster session – 7pm – 9:00pm

    NO-021

    A Phase II study of antineoplastons A10 and AS2-1 in pediatric recurrent diffuse intrinsic pontine glioma

    Stanislaw Burzynski 1 ,2, Tomasz Janicki1 ,2, Gregory Burzynski1 ,2, Ania Marszalek1
    1Burzynski Clinic, Houston, TX, USA, 2Burzynski Research Institute, Houston, TX, USA

    Brainstem gliomas (BSG) are rare tumors of which diffuse intrinsic pontine gliomas (DIPG) comprise a distinct group. Numerous trials have been conducted in DIPG without a proven pharmacological treatment benefit. Prior interim report on this phase II study of antineoplastons (ANP) A10 and AS2-1 provided data on 40 patients diagnosed with BSG. This report is focused on final results of 17 out of 40 patients diagnosed with recurrent pediatric DIPG (RPDIPG). The median age in this group was 8.8 years (range 4.5-18.5), with 9 females and 8 males. Previous treatment included radiation therapy (RT) in 15 patients, chemotherapy in 11 patients and surgery in 2 patients. At least eight weeks elapsed from initiation of ANP and previous RT and six weeks from chemotherapy with nitrosoureas. ANP was administered daily through a subclavian venous catheter via infusion pump. The median duration of treatment was 5.6 months. The median of average dosages of A10 was 8.8 g/kg/d and 0.40 g/kg/d of AS2-1. Responses were assessed by MRI repeated every eight weeks. In the RPDIPG group, a complete response (CR) was 6%, partial response (PR) 23.5%, and stable disease (SD) 23.5%. 6 month progression-free survival (PFS) was 35.3%. 1 year overall survival (OS) was 29.4%, 2 years 11.8%, and 5, 10 and 14 years 5.9%. One patient has OS and PFS of 14 years from the treatment start. Grade 4 toxicities including hypernatremia, hypokalemia and fatigue occurred in less than 18% of patients. Grade 3 fatigue, somnolence, skin allergy and urinary incontinence occurred in 6-12 %. There were no chronic adverse events. Responding patients experienced improved quality of life. The results suggest that ANP shows efficacy and an acceptable tolerability in patients with RPDIPG.

  18. #19 MedTek
    November 18, 2013

    @lilady – given the FDA’s findings about misrepresentation of responses and the loss of initial tumor measurements, I’m not sure how anyone can take it seriously.

  19. #20 lilady
    November 18, 2013

    I’d love it, if someone could flood the conference center with reprints of the USA Today article.

  20. #21 Eric Lund
    November 18, 2013

    @lilady: I don’t know whether the scientific society in question provides even minimal kook filters on conference presentations–the societies I am most familiar with do not. (Allegedly, one of the duties of the president of the American Physical Society is chairing the crackpot session at APS meetings.) I am familiar with the permute-the-author-list game they are playing–it’s normally done to evade rules against having multiple presentations by the same first author. I see that Mini-B is supposed to be one of the presenting authors. It may or may not be coincidental that the other two authors on these abstracts also have Polish names.

    As MedTek says, the FDA’s findings should make anybody question their results. Burzynski et al. may be counting on conference attendees being unaware of the FDA findings, together with the default assumption (dubious in this case) that the described work has actually been performed and the results accurately reported, to get people to view their work favorably (or at least neutrally). Sadly, I have no reason to think Burzynski et al. are wrong in this expectation.

  21. #22 Bob G
    Los Angeles
    November 18, 2013

    Ordinarily, when you apply to a conference to do a poster, you don’t submit the data (such as photos, tables, graphs), nor do you submit the methods section or much else. You send the title, list of authors, an experimental abstract, and eventually the conflict of interest statement. This is not peer reviewed published work, but a chance to present your data and arguments at the pre-publication level. The poster you present at the conference will include the methods, data, results and discussion. Of course it is expected that the work you present in poster form will ultimately be submitted for publication, but sometimes that takes a while. In Dr B’s case, the “a while” seems to be quite long indeed.

  22. #23 Narad
    November 18, 2013

    In the RPDIPG group, a complete response (CR) was 6%, partial response (PR) 23.5%, and stable disease (SD) 23.5%. 6 month progression-free survival (PFS) was 35.3%. 1 year overall survival (OS) was 29.4%, 2 years 11.8%, and 5, 10 and 14 years 5.9%.

    It’s bad enough that they saw fit to paper over the actual numbers with percentages as though the latter were results per se, but you’d think they could at least avoid hoking it up even worse by trying to make a single data point become yet more “precise” in the space of three sentences.

  23. #24 herr doktor bimler
    November 18, 2013

    Of course there are scam OA journals which would be eager to publish his work, but being a scammer himself (it takes a thief…), Burzynski probably realizes that these journals are scams.

    SCIRP has managed to extract some money from him.

  24. #25 herr doktor bimler
    November 18, 2013

    5, 10 and 14 years 5.9%

    Yes, “5.9%” does sound more scientifical than “one patient (out of 17)”.

  25. #26 Johanna
    San Francisco
    November 18, 2013

    @lilady

    Hmm, I’m in San Francisco and have access to an excellent color copier… Where’s the event (that website is not very informative – itself a bit telling, methinks…)

  26. #27 Johanna
    November 18, 2013

    PS… Aha, found it. Marriott hotel at 4th & Mission, right in downtown. *chortles*

  27. #28 Nick Theodorakis
    November 18, 2013

    @lilady, Bob G:
    When I used to present data at scientific meetings, the presentations in meetings that I used to attend were explicitly stated to be non-published data. If someone wanted to cite data from a meeting, it would have to be cited as a “personal communication.” One reason for this is that if the presentation counted as a publication, the authors could not then publish it again in a “real journal,” because it had already been published.

    There were a few societies that did publish the proceedings of their meetings, but often they ran into a “catch-22″ in that many researchers didn’t want to submit their best data there but would rather save it for more prestigious journals and meetings.

  28. #29 The Very Reverend Battleaxe of Knowledge
    November 18, 2013

    Has anybody been monitoring DJT? Has he gotten Medieval on USA Today’s ass yet?

  29. #30 Lawrence
    November 18, 2013

    @TVRBA – oh, I guess I’ve made him angry…..lol….

  30. #31 Narad
    November 18, 2013

    If someone wanted to cite data from a meeting, it would have to be cited as a “personal communication.” One reason for this is that if the presentation counted as a publication, the authors could not then publish it again in a “real journal,” because it had already been published.

    That specific example is most certainly not a “private communication” where I come from.

  31. #32 lilady
    November 18, 2013

    Johanna, that would be a great caper. Too bad, that I’m too far away from SFO to join you.

    So….are these “poster presentations” similar to the posters that the dear daughter did for her 6th grade science fair? IIRC, (it’s been soooo many years), she presented her poster on a tri-fold
    poster in the general purpose room/lunchroom of her school. She won an award for her poster presentation, even though she never published her research in a professional journal.

  32. #33 Narad
    November 18, 2013

    oh, I guess I’ve made him angry…..lol….

    I seem to be missing the part where he demonstrates the 18 CENSORED COMMENTS bit, but at least there’s the consolation of the deranged meltdown itself. “I’ll show them!!! I’ll POST DOZENS OF PICTURES OF MY PHONE FOR NO APPARENT REASON!!! AAAHAHAHAHAHA!!!!”

  33. #34 Narad
    November 18, 2013

    So….are these “poster presentations” similar to the posters that the dear daughter did for her 6th grade science fair?

    Probably in smaller type (random example from what I have on my mind; some folks do get all fancy-like).

  34. #35 Lawrence
    November 18, 2013

    @Narad – I didn’t realize I quoted quite so well…..double the pleasure, double the fun!

  35. #36 palindrom
    November 18, 2013

    In my field, it’s perfectly permissible to cite published abstracts of presentations at meetings, though if the same result has since been peer-reviewed it’s considered preferable to cite the paper instead of the presentation. And posters at scientific meetings are serious business. It’s a science fair, all right, but a professional, grown-up science fair.

    That’s not to say that B’s presentation isn’t purest BS, which it no doubt is.

  36. #37 Darwy
    Røde grøde...
    November 19, 2013

    I presented my work at a conference in France this year; as far as publication, I’m collaborating with a research group to publish together, where I’ll be listed as second author.

    Works for me.

  37. #38 Lina
    November 19, 2013

    Obviously, to Merola asking Burzynski to follow normal rules regulating medical ethics and human subject protections in clinical trials is exactly like…carrying out horrible medical experimentation

    Hmmm, about that horrible medical experimentation, Mr. Merola, funny you should mention that….

  38. #39 Lina
    November 19, 2013

    * I probably should have noted, the quote is Orac, the Goebbels quote by Merola, looks a little misleading the way I put it

  39. #40 Eric Lund
    November 19, 2013

    Marriott hotel at 4th & Mission

    That’s one block from the Moscone Center. Is this group so big that they overflow the Moscone Center? If not, then that hotel is a strange choice, as many who are going to conferences/conventions at the Moscone Center stay there (I have done so myself), and it might be difficult for other groups to get a block of rooms there.

    In any case, good luck on your mission.

  40. #41 Johanna
    November 19, 2013

    @Eric – I seriously doubt it, as the Salesforce hoedown is occupying Moscone all week long – and, by gum, they’re almost as bad as Oracle World. I suspect it’s far more likely that The World Federation of Neuro-Oncology has merely rented a couple of meeting rooms at the Marriott itself (although I’m surprised they had anything – Salesforce has consumed South of Market…)

  41. #42 Eric Lund
    November 19, 2013

    That may be why they had to hold the meeting on a Friday evening–my guess is that the Salesforce people will be either out partying, or on their way home. But it must have been a challenge for people going to the Neuro-Oncology conference to get hotel rooms. I’m part of a group that meets annually at the Moscone Center, and the hotel booking crew feels compelled to offer us options in the Fisherman’s Wharf area, as well as a hotel or two out on Van Ness. I prefer something closer, like Union Square.

  42. #43 Johanna
    November 19, 2013

    @Eric – next time you’re looking for a place near Union Square, check out Hotel Diva. It’s a wonderful spot across the street from the A.C.T. on Geary. It’s fabulous, in every sense of the word.

  43. #44 W. Kevin Vicklund
    November 19, 2013

    NO-020

    A Phase II study of antineoplastons A10 and AS2-1 in adult patients with recurrent glioblastoma multiforme based on Protocol BT-21

    Gregory Burzynski 1 ,2, Stanislaw Burzynski1 ,2, Tomek Janicki1 ,2, Ania Marszalek1
    1Burzynski Clinic, Houston, TX, USA, 2Burzynski Research Institute, Houston, TX, USA

    Treatment of recurrent glioblastoma multiforme (GBM) creates one of the most difficult challanges in neuro-oncology. The aim of this presentation is to evaluate the responses and survival of 24 recurrent GBM patients and toxicity in all 33 eligible patients. The study accrued patients who developed disease progression during standard treatment within eight weeks from completion of radiation therapy (RT) and six weeks from chemotherapy. Forty candidates were registered but only 33 patients were eligible. The seven noneligible patients received less than 28 days of treatment with Antineoplastons A10 and AS2-1. Among the eligible patients there were 24 cases of recurrent GBM that progressed during prior treatment, four patients with anaplastic astrocytoma and five persistent GBM. Previous treatment included surgery in all patients (18 had tumor resection, and 6 underwent biopsy only), chemotherapy in 75% of patients and radiation therapy in 88% of patients. Antineoplastons were administered intravenously every four hours (median dose of A10 10.7 g/kg/d and AS2-1 0.43 g/kg/d) until objective response was documented or until progression. The median duration of ANP treatment was 13.2 weeks ranging (4.6 – 80.3). Responses were assessed by MRI repeated every eight weeks, and or PET scan. Objective responses were determined in 16.7% of cases (complete response, and partial response in 8.3% each). Progression-free survival at six months was 25%. Overall survival is 39.3% at one year, 4.4% at two years, five and ten years. The treatment was well tolerated with reversible grades 3 and 4 toxicity including four cases of hypernatremia, two of fatigue, two of hypokalemia, and a single case of somnolence. There were no chronic toxicities. In conclusion, ANP is well tolerated and compares favorably to the current treatment for recurrent GBM.

    So some interesting numbers there. Out of 33 eligible patients:

    16.7%*33= 5.5 had a complete or partial response (2.75 for each type)

    25%*33= 8.25 had progression-free survival at six months

    39.3%*33= 13 lived at least one year

    4.4%*33= 1.5 lived at least 2 years (and were still alive 10 years later

    Where is he getting all these half and quarter patients? Well, maybe he was talking about the 24 recurrent GBM patients and just got sloppy in the abstract:

    16.7%*24= 4 had a complete or partial response (2 for each type)

    25%*24= 6 had progression-free survival at six months

    39.3%*24= 9.43 lived at least one year

    4.4%*24= 1.06 lived at least 2 years (and were still alive 10 years later

    As near as I can tell, the 4.4% only works for 1 out of 23 patients, if you work with integers and properly round. And the 39.3% doesn’t seem to have been properly rounded (unless the numbers are 11 of 28) – 13/33=39.4%.

    So I’m betting he’s mixing his groups (eligible vs. recurrent GBM patients) to put forward the best numbers without telling the reader that he’s doing so. Whatever he is doing, his math at some point is wrong.

  44. #45 Eric Lund
    November 19, 2013

    So I’m betting he’s mixing his groups (eligible vs. recurrent GBM patients) to put forward the best numbers without telling the reader that he’s doing so.

    Your explanation of Mini-B’s math is more generous than mine would be. As the old joke says, 43% of statistics are made up on the spot.

  45. #46 Shay
    In a holding pattern
    November 19, 2013

    When I was on active duty we referred to that as either SWAG (Scientific Wild-Ass Guess) or MSU (Making Sh%t Up).

  46. #47 herr doktor bimler
    November 19, 2013

    The seven noneligible patients received less than 28 days of treatment with Antineoplastons A10 and AS2-1

    What happened then? Were they poisoned too badly to include them in rating ‘toxic response’ , or did their bank accounts run dry?

  47. #48 ChrisL
    November 19, 2013

    @WKV – the way the abstract is worded, it isn’t that sloppy in that it does state in the second sentence that response and survival was evaluated in only 24 patients, and that the 33 “eligible” patients provided toxicity data. If they assessed survival using the Kaplan-Meier method (as would be the norm), the survival results can’t be calculated from the raw data in the abstract.

    With respect to the 9 patients (= 33 – 24) who were “eligible” but did not contribute to the response or survival analysis, they are the 4 with anaplastic astrocytoma and the 5 with persistent GBM. So the title indicates that the abstract is focusing on those with recurrent GBM, but presumably the actual protocol allowed enrolment of patients with AA and persistent GBM. Certainly leaves one suspicious that the response and survival data for those 9 weren’t good. If the study allowed them to take part, why exclude them from the response and survival analysis?

    What is definitely suspicious is declaring 7 patients (= 40 – 33) as “ineligible” because they started but didn’t complete 28 days of study treatment. They were enrolled, so presumably were “eligible” for the study. If you want to “exclude” them from the response analysis because they didn’t get enough drug to have an effect on tumour… may be defendable, but you’d still expect them to contribute to the toxicity results. Especially as severe toxicity may well have resulted in early discontinuation of treatment as pointed out by herr doktor bimler.

  48. #49 Tony Brunt
    Christchurch, New Zealand
    November 19, 2013

    Yippee, I’m a “pharmawhore”. I posted a couple of links to this article and the USA today article, and, um, suggested that Dr B was a quack on a Facebook share of Eric Mercola’s site. And wouldn’t you know it, my comment has mysteriously disappeared, with a comment saying that some pharawhores have posted! Nothing like allowing a free and open debate! And the funniest bit of all is that I am a humble gardener that has nothing to do with with the medical world at all. (Full disclosure, I did date a Doctor once, but she traded me in for a fisherman)

  49. #50 Narad
    November 20, 2013

    Whatever he is doing, his math at some point is wrong.

    Maybe it’s a running gag of some sort.

  50. #51 herr doktor bimler
    November 20, 2013

    Maybe it’s a running gag of some sort.
    It must be a tradition, or an old charter or something.

  51. #52 dingo199
    November 20, 2013

    Over this side of the pond, we need to keep original documentation and case records on every patient in a trial for a minimum of 28 years.

    ..and excessive somnolence has been called out as a “horribly devastating neurological side effect” of the pandemic flu vaccine.

  52. #53 Andreas Johansson
    November 21, 2013

    Narad wrote:

    I’d spend some time complaining about the chi in the logo if I didn’t have to be out the door two minutes ago.

    Just pretend they’re using one of those western variants of the Greek alphabet that used chi for /ks/.

  53. #54 Andy
    November 21, 2013

    A little off topic but – whatever happened to the PR guy (not Merola) who started working for BRI a year or so ago?

  54. #55 Narad
    November 22, 2013

    A little off topic but – whatever happened to the PR guy (not Merola) who started working for BRI a year or so ago?

    Marc Anthony Stephens, (562) 843-9398, mastephens1@gmail.com,
    nitwit extraordinaire, of maswebdesignhosting.com, independentcreditrepair.com, and (suspended) California entity C2908971, MAS Acquisitions, Inc.? This seems consistent.

  55. #56 Narad
    November 22, 2013

    The craptastic autolinking of E-mail addresses has me in the mod queue. I think Stephens is here.

  56. #57 Narad
    November 22, 2013

    Yah, a search on “800-686-1065″ is dead-on for his “talents.” Check this one out.

  57. #58 Woo Fighter
    November 22, 2013

    I think Andy is asking about former Houston TV reporter Wayne Dolcefino, not Stephens.

    Dolcefino only lasted a few months representing Burzynski; I speculate he was retained on a short-term contract (six months?) and when Burzynski realized he wasn’t getting any results from Dolcefino, his contract with the clinic was not renewed.

    Dolcefino reached out to David James on the Skept!cal blog and responded to a handful of emails, wherein he was caught in several lies and much evasiveness. David never established whether Dolcefino really didn’t know the truth or was covering it up.

    Dolcefino’s only other claim to fame working for Stan was orchestrating that appearance by Josh Duhamel at the clinic last Christmas, which was recorded and posted on the clinic’s webiste for posterity.

  58. #59 Woo Fighter
    November 22, 2013

    On a slightly unrelated note, Merola has started hinting about his new documentary called Second Opinion, coming out in 2014. He is also teasing that there will be a companion book to the film, but he is withholding all other information until a later date.

    He did post a couple of “hints” about the movie and it seems to revolve around the US government’s “war on cancer” first announced by Richard Nixon and what he perceives to be either FDA corruption or incompetence.

  59. #60 Woo Fighter
    November 22, 2013

    Merola set up a Facebook page for his new movie a few weeks ago:

    https://www.facebook.com/SecondOpinionMovie

  60. #61 Narad
    November 22, 2013

    I think Andy is asking about former Houston TV reporter Wayne Dolcefino, not Stephens.

    Rats, that’s too bad, as Stephens seems to be wallowing in desperate scammer insanity.

  61. #63 Ritchie Annand
    November 25, 2013

    “I’d spend some time complaining about the chi in the logo if I didn’t have to be out the door two minutes ago.”

    We can just hope that it refers to the chi squared test, which is a reasonably common test in biological studies :)

  62. #64 mulberry sale
    http://www.motleyandhope.co.uk/p7ap/linkss.php?module=list&brand=mulberry-sale&page=1
    November 26, 2013

    Eric Merola and Stanislaw Burzynski respond to the FDA findings and the USA TODAY story. Hilarity ensues. – Respectful Insolence mulberry sale http://www.motleyandhope.co.uk/p7ap/linkss.php?module=list&brand=mulberry-sale&page=1

  63. #65 Tiffany
    November 26, 2013

    *sigh* When is somebody going to take this man’s meducal license? http://practicalfrugality.com/please-read-help-save-12-year-old-mckenzie-lowe/

  64. #67 Renate
    December 1, 2013

    What is DJT trying to say on his blog? With alies like him, I suppose one doesn’t need enemies.

  65. #68 Kassandra
    December 22, 2013

    Ya’ll ought to get the other side of the story. Burzynski has been pursued by the FDA, the AMA and the Federal government for years.
    They’ve tried to steal his patents even. The only reason he’s still in practice is his high powered attorneys and a a very savvy way off fighting off the establishment
    He actually DOES cure cancer…and they don’t like it. They went after Linus Pauling ( Nobel physicist in the same way. Why? becasue cancer is big business in American hospitals.
    How many success stories does big PhRMA have with their cut, burn and poison approach? Not many. But THEY sure make $$$ off the suffering, don’t they? Even tho most of their patients recur after 5 years.
    No treatment is going to be 100% successful.
    Go take a look at the other side before you self righteously pass judgment based on AMA propaganda. It may save your or someone else’s life:
    http://www.burzynskimovie.com/

  66. #69 TG
    January 19, 2014

    Thank you, Kassandra.

  67. #70 Scottynuke
    January 19, 2014

    Or Kassandra could have taken a moment to use the search function up top of the page and seen that the piece of flaming propaganda she’s pimping has been deconstructed time and time again.

    But bots never stop to check, now do they?

  68. #71 Helianthus
    January 19, 2014

    @ Kassandra

    Oh, a Cassandra. Cursed by the Greek gods to never be believed when she tells the True.
    Trying a few lies to see if you have better luck?

    Go take a look at the other side before you self righteously pass judgment based on Burzynski propaganda. It may save your or someone else’s life:
    The other Burzynski patient group

  69. #72 Narad
    January 19, 2014

    They went after Linus Pauling ( Nobel physicist in the same way.

    *koff*

  70. #73 lilady
    January 19, 2014

    “They went after Linus Pauling ( Nobel physicist in the same way.”

    Hmmm, must be a different Linus Pauling than the Linus Pauling who was awarded a Nobel Chemistry prize and the Nobel Peace Prize.

    http://en.wikipedia.org/wiki/Linus_Pauling

  71. #74 herr doktor bimler
    January 19, 2014

    I was wondering whether Narad’s cough was directed at Pauling’s upgrade from chemistry to physics, or the claim that “They went after Linus Pauling … in the same way”.
    Precisely when the FDA (or anyone else) “went after” Pauling — other than in Kassandra’s rich fantasy life — remains undocumented.

  72. #75 Narad
    January 19, 2014

    Mainly the former, but the latter certainly occurred to me. I assume that “they” had a nonspecific antecedent.

  73. #76 Militant Agnostic
    January 19, 2014

    @HDB

    Pauling’s upgrade from chemistry to physics

    Bit of a hidden assumption there. Is this because crankery in old age is supposed to be the sole privilege of physicists?

  74. #77 herr doktor bimler
    January 19, 2014

    Bit of a hidden assumption there.
    Biassed by my own qualification? UNPOSSIBLE.

  75. […] So what is this interview I’m talking about? Well, the Burzynski propaganda machine, even as diminished and battered as it is in the wake of the USA TODAY report by Liz Szabo in November, still exists. To fire it up […]

  76. […] and detail. Early on, Stanislaw Burzynski and his minions tried to do some damage control, with hilarious results given how inept and unconvincing his excuses were for all the violations of ethics and patient care […]

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