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

Mark Crislip, founder of the Society for Science-Based Medicine, whose board of directors I’m proud to be serving on, an organization that you should join if you haven’t already, sometimes jokes that our logo should be an image of Sisyphus, the king of Ephyra whom Zeus punished by compelling him to roll an immense boulder up a hill. However, the boulder was enchanted and, as soon as Sisyphus reached the top, it would roll back down the hill. Sisyphus was thus forced to repeat this action throughout all eternity. The metaphor is obvious. Those of us who try to combat quackery and the infiltration of pseudoscience in medicine often feel a lot like Sisyphus. I always used to argue that, as amusing as it might be to have such a logo as an “in” joke, it’s far too much of a downer to inspire what SSBM wants to inspire: Action in the form of volunteers taking on projects, such as converting Quackwatch into a wiki and then continuously updating and adding to that wiki indefinitely. We have to believe that there is hope of someday succeeding. “Let’s push that boulder up a hill one more time!” does not exactly constitute an inspiring rally cry, although I can definitely understand the feeling at times the older I get and the longer I’ve been doing this. We can all appreciate gallows humor at times, and, besides, I’m not that pessimistic. I can’t afford to be.

Even so, I can understand the Sisyphus analogy right now with respect to an unfortunately frequent subject of this blog, the doctor in Houston who proclaims himself a cancer doctor, even though he has no formal training in medical oncology, isn’t even board-certified in internal medicine, the prerequisite for undertaking advanced training in medical oncology, and has no discernable training in clinical trials management. I’m referring, of course, to Stanislaw Burzynski, MD, PhD, the Polish doctor who since 1977 has been treating patients with substances that he has dubbed “antineoplastons” (ANPs). What are ANPs? Burzynski claimed to have discovered ANPs during his time at Baylor and described them as endogenous cancer-fighting chemicals in human blood and urine. Unfortunately, he soon became convinced that only he could develop them into an effective chemotherapy drug and left Baylor to administer ANPs to his own cancer patients. Patients flocked to him because he claimed to be able to cure cancers that conventional medicine can’t cure.

This led to a series of battles between Burzynski and various authorities, including the Texas Medical Board, the FDA, and various attorneys general, because of his use of ANPs, which are not and never have been FDA approved, as well as for various—shall we say?—issues with insurance companies. Ultimately, in the 1990s Burzynski beat the rap and effectively neutered the FDA’s case against him by submitting dozens of clinical trials to the FDA for approval, which, given how much pressure the FDA was under from Burzynski’s friends in high places (like Texas Representative Joe Barton), the FDA ended up approving. However, as Burzynski’s lawyer himself bragged, these clinical trials were shams designed to allow Burzynski to keep treating cancer patients, not clinical trials designed to produce any real evidence of efficacy. Not surprisingly, although Burzynski has published the odd case report or tiny case series, he has not yet published the full results of even a single one of his many phase II trials. There is, quite simply, no convincing evidence that ANPs have significant antitumor activity in vivo in humans, even after 37 years. Meanwhile, the FDA has found numerous examples of Burzynski’s abuse of clinical trials, failure to keep necessary data, and failure to protect human subjects, while exposés by BBC Panorama and Liz Szabo at USA TODAY have been most unflattering, revealing at least one dead child as a result of the toxicity of Burzynski’s drug and a pattern of minimizing and hiding reports of adverse reactions.

I had at least two other ideas for what I thought would be informative, entertaining, and timely posts, but then late last week I found out about a new development in Burzynski’s latest battle to try to use patients as weapons again to bring pressure to bear on the FDA (as he did in the 1990s) to allow patients with brain tumors to be treated with ANPs under single patient INDs, also known as compassionate use exemptions or expanded access programs. Such exemptions allow some patients who have no good conventional options access to unapproved investigational agents. Ironically, one of the most damning findings about the Burzynski Research Institute and Burzynski Clinic from the FDA investigation last year was how Burzynski would play fast and loose with the rules regarding approval by the institutional review board (IRB) of such exemptions. IRBs are committees mandated by the Office for Human Research Protections (OHRP) to protect human research subjects by approving and monitoring clinical trials to make sure that patients are not placed at undue risk, that proper informed consent is given, and that clinical trials conform to all ethical and legal requirements. Let’s just put it this way. The FDA caved. You’ll see what I mean shortly. Worse, it caved in a way that basically abdicated its responsibility.

Those of you who read my not-so-super-secret other blog will realize that I’ve already begun the discussion over there, making part of this post repetitive. However, there have been new developments over the weekend, and I very much want a record of this abdication of duty by the FDA on this blog as well—in more detail, of course.

“Just when I thought I was out, they pull me back in.”

Sadly, the brief little quote from Michael Corleone (as played by Al Pacino) in The Godfather, Part III, basically sums up my feelings with respect to Stanislaw Burzynski. Every time I think that I can give the topic a rest for a while (and, believe me, I do want to give it a rest), something invariably seems to happen to pull me back in. So it was Thursday evening, when I was made aware of a new development so disappointing that I’m still wiping the dirt off my chin from my jaw dropping to the floor. Even more amazing is that my disappointment stems from my perception of cynicism that actually was not Burzynski’s, but rather by the FDA in response to Burzynski’s cynical use of cancer patients as shields and weapons against the FDA that has led some of us who support science-based medicine to be subjected to criticism from the families of patients with cancer, who have been erroneously convinced that Stanislaw Burzynski is their loved ones’ last chance to survive. Actually, I can’t tell if it’s a cynical move or a breathtakingly naïve move, but it’s a huge mistake regardless, as you’ll see. I’m guessing that some will think of it as a very clever move, and so it is, but it’s a cleverness we could use less of.

About a year ago, Burzynski was once again investigated by the FDA. Because of the death of a patient due to hypernatremia (elevated sodium level) due to ANPs in 2012, the FDA put a partial clinical hold on his pediatric clinical trials and extended it to all of his clinical trials. What this means is that, although Burzynski can continue to treat patients who are already in his clinical trials, he can’t enroll any new patients in them. Of course, one of the big issues with Burzynski that contributed to his problems is that he abused the FDA process known as the single patient IND, which is more commonly known as the compassionate use exemption. These are special case exemptions in which a single patient is allowed access to an investigational agent outside the auspices of a clinical trial. Indeed, when the FDA slapped him down most recently, in December, one of its findings was just that: Burzynski abused the single patient IND process and his institutional review board (IRB), the committee that’s supposed to oversee clinical trials and safeguard the interests and safety of clinical trial subjects, played fast and loose with the rules.

Since the appearance of a USA TODAY story by Liz Szabo spelling out all of these issues, Burzynski has been frantically trying to save his empire. Whether “encouraged” by Burzynski or just by one of the patient groups that have become true believers, patients with deadly cancer have been starting petitions, pressuring legislators to intercede on their behalf to the FDA, and paint Burzynski’s ANPs as their only hope of survival. I have no doubt that these patients believe it, but they have the potential to inadvertently do great mischief to the law, either through their use of their tragic stories to promote misguidedright to try” laws or through their use of patient stories to pressure the FDA to loosen protections on human subjects in clinical trials. Perhaps the most tragic story is that of Rafael Elisha Cohen, a six-year-old child with medullablastoma who is not doing well and whose parents have been at the forefront of pressuring the FDA. As horrible as the Cohens’ situation is—and we all understand that it’s a horrible, horrible thing to have a child dying of brain cancer—unfortunately, the FDA appears to have decided to cave. The other day, on a Facebook page dedicated to raising money and pressuring the FDA, Devorah Teicher Cohen announced:

UPDATE-

Thanks to everyones hard work the FDA did end up approving the Antineoplastins for compassionate use – they do not let Dr B administer it.

The condition is, if an oncologist request this protocol FDA will issue compassionate use within 24 Hours.

FDA recognizes the data of those who survived aggressive brain tumors due to the ANP and is therefor after a long and cruel wasting TIME period allowing it. There are currently 8 pediatric patients that need this medicine NOW!!!!

Refael Elisha can not travel at this point…so we would need an oncologist in the NY area… we are in touch with other kids that are ready to get on a plain if they get the signal of a cooperating oncologist.

It is beyond words to express our sadness that FDA ended approving the drug but Elisha is in critical condition at the moment.

We are not holding our breath and are trying different alternatives , If HASHEM wills it we will get the medicine but if not, that is from Hashem for the good. in the meantime Please put your fillers out there and message me in privet if you have any leads , even if not in NY it might work out for the other desperate children.

im copying the announcement from ANP site

Wanted: One brave courageous oncologist or oncologists willing to examine and treat up to eight pediatric brain cancer patients who have run out of treatment options and now require a Compassionate Use IND Emergency Treatment protocol from the U.S. Food and Drug Administration. The ANP Coalition needs your help now. Please visit www.anpcoalition.org or call (925) 699-9116. Thank You

When I first saw this message on the Prayers for Elisha Facebook page, I was cautious. I could find confirmation of this news nowhere else, not even on the ANP Coalition webpage. Then, on Friday afternoon, Liz Szabo, the USA TODAY reporter who previously published her epic expose of the Burzynski cancer machine back in November, basically confirmed the report with a followup story in USA TODAY, FDA agrees to let patients get controversial drug:

The Food and Drug Administration has agreed to allow a handful of cancer patients to receive unapproved drugs from a controversial Texas doctor, but only if they can find another physician to administer them.

The drugs are made by Houston doctor Stanislaw Burzynski, who was the subject of a USA TODAY investigation last year. While his supporters consider him a medical maverick, mainstream doctors describe him as a snake-oil salesman. Burzynski has claimed for more than 36 years to be able to cure certain hard-to-treat brain tumors with drugs he calls antineoplastons. The National Cancer Institute notes that Burzynski has never published definitive evidence that his drugs cure cancer or even help people live longer.

Burzynski has been unable to give these drugs since 2013, when the FDA placed his experiments on hold after the death of a 6-year-old New Jersey boy taking antineoplastons. In December, the FDA sent Burzynski a warning letter, noting that he inflated his success rates and failed to report side effects and to prevent patients from repeatedly overdosing. The Texas Medical Board also charged Burzynski last year with false advertising.

None of this stopped the FDA from caving:

The FDA acknowledged Friday that it has agreed to allow them to use the experimental drug, but only if they can find a qualified, independent physician to administer the drug. Beyond infusing the drug and overseeing their care, the doctor would have to formally apply for expanded access to an “investigational new drug,” as well as get approval from an institutional review board, an independent panel that reviews safety and ethical issues involved in clinical trials.

Can anyone figure out why I can’t make up my mind whether this decision, if what the Cohens say is true, is stunningly cynical or stunningly naïve on the part of the FDA? Instead of standing firm for science and gently continuing to point out that it can’t allow any more single patient INDs for ANPs be approved based on science, Burzynski’s past violations of FDA regulations, and, above all, the need to follow the FDA’s mandate and mission to protect vulnerable cancer patients, instead the FDA has dangled more false hope of a single-patient IND in front of Elisha’s family (and the eight other children petitioning for such INDs). It’s hard to believe that the FDA is not aware that it is incredibly unlikely that any reputable pediatric oncologist would agree to administer ANPs under these conditions, given Burzynski’s reputation.

In a way, what the FDA is doing inadvertently compounds the families’ agony. Now they have hope again, except that this time it’s doubly false: False because, based on existing evidence and what we know now, ANPs almost certainly don’t work and false because of how incredibly unlikely it is that any pediatric oncologist will take on such a patient and administer ANPs, given Burzynski’s history, the utter lack of supporting science for the efficacy of ANPs, and the not-inconsiderable amount of work and expense that would be necessary in order to do so. The families will now be showing up in the offices of pediatric oncologists, begging them to agree to do a single patient IND and administer ANPs to these patients. Ditto some adult oncologists. Indeed, according to Szabo’s report, Liza Covad-Lauser, wife of rock star Sammy Hagar’s drummer David Lauser, claims that she has already found a doctor willing to administer the antineoplastons. One wonders if this doctor knows what he is getting himself into. As cynical as it might sound of me to say so, I can’t help but wonder whether being the wife of a member of a rock star’s band, who can garner signatures on petitions by other rock stars, has an effect.

Here’s why the FDA’s action is doubly cynical (or nave). As alluded to in Szabo’s article, according to FDA regulations, there are a number of requirements for a single patient IND and several things any physician seeking to administer an investigational agent as a single patient IND must do. Here’s the most important one that makes it even more unlikely that any single patient IND will be granted, except for perhaps briefly as an “emergency exemption” in which IRB approval can be briefly deferred:

5. Informed Consent Statement that states that informed consent and approval of the use by an appropriate Institutional Review Board (IRB) will be obtained prior to initiating treatment. In the case of an emergency, treatment may begin without prior IRB approval, provided the IRB is notified of the emergency treatment within 5 working days of treatment.

See what I mean? Even if a family were to find an oncologist willing to jump through all the hoops to get a patient on a single patient IND to be treated with ANPs, that single patient IND would still have to be approved by the IRB of the institution where that oncologist practices. Sure, the oncologist could declare the treatment an “emergency”—although in none of the cases that I’m aware of other than that of Elisha Cohen could be properly termed an emergency so urgent that the physician couldn’t wait a week or two to have the IRB formally discuss the IND, even if ANPs actually did have any efficacy—and start treatment pending IRB approval, but as soon as the IRB convened to discuss the IND, very likely the plug would be pulled. No more ANPs. Remember, these would be real IRBs, not Stanislaw Burzynski’s sham IRB chaired by an old crony of his.

There’s another question to consider. Stanislaw Burzynski routinely used to treat some of these patients for free, supplying ANPs for no cost and waiving case management fees. No doubt this offer was primarily for publicity, to blunt the accusation that, based on the exorbitant amounts of money charged to previous patients, Burzynski is in it for the money. So, not surprisingly, according to Szabo’s report, Burzynski is still offering to provide the drug for free. That’s all well and good, but it leaves all the other expenses of treatment, which will not be paid for by insurance because ANPs are not an FDA-approved drug. Who’s going to pay for all of that? While it is true that some of the families have raised quite a bit of money (Elisha’s family, for instance, has raised nearly $150,000), others aren’t so lucky.

A massive Burzynski propaganda victory?

Supporters of Stanislaw Burzynski wasted no time in using the FDA decision to defend Burzynski and, ironically, to attack the FDA. Many of you might remember McKenzie Lowe, the 12-year-old girl diagnosed with diffuse intrinsic pontine glioma (DIPG) in 2012. Her family has been trying to have her treated by Stanislaw Burzynski, making videos and lobbying Congress. Indeed, they succeeded in persuading their senator, Senator Kelly Ayotte (R-NH), to write to the FDA urging it to consider allowing McKenzie to be treated by Burzynski. On a Facebook page Friends of McKenzie Lowe, a message was posted on Sunday simultaneously rejoicing at the news as evidence that McKenzie has a chance to live and lambasting Liz Szabo:

As you all probably have read in the USA Today the FDA has agreed to let Mckenzie and the other people who want to use ANP CAN USE IT!!!! FANTASTIC!!!!! But as you can see the writer of the article is very bias on the negative side. As usual she one again took something good for these patients and in stead of focusing on the positive response from the FDA she took another swing at bashing Dr. Burzynski and his clinic. There was no mention of or comments from Anthony Stout, Rick Schiff, Jessica Ressel, Randy Hinton, Philip Norton and many many more..

Let’s go back in history to all the nay Sayers that said Christopher Columbus was crazy. The world is flat, you will fall off the end. Hmmm. Einstein was a quack… Hmmm. Isaac Newton and Galileo were also shunned by their peers… Thank god they had the fortitude to push aside the nay sayers and continue to prove them ALL wrong. Imagine where we would ALL be today if they had listened to their critics and not persevered with what they believed.

Unfortunately, this is known as the Galileo Gambit, a nice, concise term used to argue that if you are vilified for your ideas it must mean that you are right. Unfortunately, what supporters of pseudoscientists and quacks frequently forget is that there are two requirements necessary to be able to credibly claim the mantle of Galileo. Not only must you be vilified, but you must be correct. Only one of these applies to Stanislaw Burzynski, and it isn’t the second one.

As has been the case whenever I’ve discussed patients like McKenzie Lowe, Liza Covad-Hauser, Rafael Elisha Cohen, and others, I understand, at least as much as it is possible to understand without actually being in their shoes. As I’ve pointed out before, it was only five years ago that my mother-in-law died of widely-metastatic breast cancer. Burzynski couldn’t have saved her. ANPs couldn’t have saved her. And I know I’m going to take some flak for saying this, but ANPs cannot save McKenzie Lowe. At least, there is no convincing evidence that they can, and, quite frankly, the only blame for why this is true should be placed at the feet of Stanislaw Burzynski himself. He’s the one who, thinking himself the “brave maverick doctor” to whom the rules of science don’t apply, has failed to produce such evidence. While I understand the desperation these families are feeling, I keep hoping that they will realize that it is not doing McKenzie, Elisha, or any of the others any favors to subject them to toxic chemotherapy—and, make no mistake, ANPs are toxic chemotherapy, efforts of advocates to paint them as “natural” and “nontoxic” notwithstanding. As I’ve pointed out time and time again: If there’s anything worse than dying of a terminal illness, it’s dying of a terminal illness and suffering unnecessary complications or pain for no benefit in the process.

I can totally understand why families like the Lowes might become very excited about the possibility of being able to use ANPs. As misled as they have been and mistaken as their belief is, they do, after all, genuinely believe that ANPs represent the last chance their loved ones have to be able to survive their cancer. Unfortunately, our old “friend” and Burzynski’s very own propagandist, Eric Merola, who has produced two fawning “documentaries” about the Great Man chock full of misinformation and exaggerations, coupled with attacks on Burzynski critics and skeptics, has no such excuse and deserves none of the compassion that we should all have for patients dying of brain tumors and the families who love them. Not surprisingly, he, too, has leapt into the fray with a typically frothing-at-the-mouth conspiracy-laden pile of fetid dingos’ kidneys of a response to Liz Szabo’s story, in which he examines it line-by-line and basically responds with typical Burzynski propaganda, misinformation and lies.

There’s too much there for a full response in this post. Besides, most of the misinformation that’s there I’ve covered before, often multiple times. Perhaps I’ll respond a bit more on my not-so-super-secret other blog. Here, I simply want to point out a few of the most egregious examples. For example, here is probably the most egregious lie on Merola’s part:

A DIPG in a child has never been cured in medical history — why would the FDA make such a claim in this case? It’s quite simple, the science proved it works and cures in many cases, and therefore the science was allowed to progress. There are no “claims” other than what can be proven. Maybe it’s because the cancer industry doesn’t like anyone else “claiming” anything as they own the luxury of claiming what cancer medications work or not work — and we know how well that has worked out for us.

As I’ve pointed out before, this is, quite simply, untrue. It’s also been pointed out time and time again to Merola that this is untrue. Long-term survival for patients with DIPG is rare, definitely, but it’s always dangerous to make an absolute statement like the one that Merola has done. Contrary to Burzynski’s claim, there are occasional long-term survivors, some of whom received little or no therapy, such Connor Frankenberg, a child from Germany, and two patients who underwent spontaneous remission. There is even a site, the DIPG Registry, whose purpose is reporting on how patients with DIPG do and promoting Just One More Day, a registered non-profit 501(c)(3) organization dedicated to helping families affected by a diffuse intrinsic pontine glioma, established by the families of DIPG victims. The DIPG Registry concludes that, although the vast majority of children with DIPGs do poorly:

The bottom line is: 1) we really don’t understand DIPGs, and 2) there are children who have been diagnosed with DIPGs-based on the incomplete knowledge that we currently have- who truly have had spontaneous regression of their tumors and 3) most of the children with reports of spontaneous regression have been very young.

Young like Tori Moreno, I might add.

The big problem is that Burzynski appears not to keep good enough records to demonstrate one way or the other whether he can cure DIPG, and we already know from recent FDA findings and Liz Szabo’s USA TODAY report that he has misclassified partial and complete responses. Yes, DIPG is a horrible disease, with only 10% surviving beyond two years. Unfortunately, there is no convincing evidence that Burzynski can do any better than conventional oncology, much less cure DIPG, as much as his propagandist Eric Merola repeats the claim that he can. Worse, Burzynski hasn’t published a single one of his completed phase II clinical trials, even though he’s had well over 15 years to complete them. With tumors this lethal, most such trials should be completed within five years, which brings us to more of Merola’s misinformation:

The National Cancer Institute notes that Burzynski has never published definitive evidence that his drugs cure cancer or even help people live longer.

The above links are examples definitive published evidence. Notice how this writer links to a PDF highlighting her point, vs. the National Cancer Institute (NCI) website itself. Is it perhaps because on the NCI website it clearly says:

“A phase II study also conducted by the developer [Burzynski] and his associates at his clinic reported on 12 patients with recurrent and diffuse intrinsic brain stem glioma. Of the ten patients who were evaluable, two achieved complete tumor response, three had partial tumor response, three had stable disease, and two had progressive disease. Patients ranged in age from 4 to 29 years.”

The NCI felt its own source to be “definitive enough”, why not Liz?

*Source:

http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page5#Reference5.12

Merola clearly does not understand the difference between “responses” and cures. Similarly, he does not understand what constitutes “definitive evidence.” (Hint: It isn’t case reports, tiny case series published in bottom-feeding journals, or incomplete phase II trials. Moreover, just because the NCI cited a crappy review article by Burzynski that reported partial results phase II trials, a ten year old partial report of a phase II trial, a dubious paper published in an integrative medicine journal, and another review article published by Burzynski in a journal that appears not to be even indexed by PubMed does not constitute “definitive evidence” that ANPs work. All it means is that the NCI was examining the existing published evidence on its way to writing this:

To date, no randomized controlled trials examining the use of antineoplastons in patients with cancer have been reported in the literature. Existing published data have taken the form of case reports or series, phase I clinical trials, and phase II clinical trials, conducted mainly by the developer of the therapy and his associates. While these publications have reported successful remissions with the use of antineoplastons, other investigators have been unable to duplicate these results [10] and suggest that interpreting effects of antineoplaston treatment in patients with recurrent gliomas may be confounded by pre-antineoplaston treatment and imaging artifacts.[11,14,16] Reports originating from Japan on the effect of antineoplaston treatment on brain and other types of tumors have been mixed, and in some Japanese studies the specific antineoplastons used are not named.[9] In many of the reported studies, several or all patients received concurrent or recent radiation therapy, chemotherapy, or both, confounding interpretability.

Mr. Merola, that’s hardly “definitive”! Nor is the “definitive” study by Hidaeki Tsuda featured in the second Burzynski movie, given that nothing has been published to allow us to evaluate the methods. Nor is the fact that The Lancet Oncology apparently editorially rejected a manuscript submitted by Burzynski evidence of any sort of “conspiracy” against him. Indeed, I now probably know why Burzynski’s manuscript was rejected. Look at the title: “Glioblastoma multiforme: A report of long-term progression-free and overall survival of 8 to over 16 years after antineoplaston therapy and a review of the literature”. Yes, the title seems to indicate that this is just another small case series. No wonder The Lancet Oncology didn’t even bother to send it out for review!

Of course, Merola can’t resist a swipe at yours truly, who was quoted in the article:

A guy who is paid to write blogs attacking this innovation and other innovations that compete with the status quo, a guy who has never once met a Burzynski patient, never once visited the Burzynski clinic, a guy who supposedly finished his residency and now writes “thought police” blogs for a living — yeah, let’s hear more about what this guy has to say, that’s productive. He does fit the angle for Liz’s one-sided propaganda, so I understand why she included his irrelevant opinion.

I don’t know whether to laugh or be annoyed at Merola’s continued lies about me. Once again, I do not need to visit the Burzynski Clinic to know that ANPs almost certainly don’t work. I did finish my residency and am board certified in surgery. If Mr. Merola doesn’t believe that, he can go to the American Board of Surgery website and search for my name in the section that lets the public verify the board certification of surgeons, realizing that you can’t become board certified without finishing an accredited residency. Finally, I don’t actually blog for a living. It’s my hobby. I’m not paid at all for my work at SBM, and at my not-so-super-secret other blog I make a small amount of money that I could completely do without if that gig ever went south or I decided to bolt. As for having something worthwhile to say, well, let’s just say that I’d put my record for science-based analysis against Mr. Merola’s record for pseudoscience-based propaganda any day, particularly in light of his latest paean to another brave maverick, this time promoting the long-discredited cancer quackery known as laetrile.

At least Merola included a link to my page on SBM. He seems to think it’s something nefarious, while I’m more than happy to include a link to it here. Please, read.

Why did the FDA cave?

What is puzzling to me is why the FDA caved. While it is true that the ANP Coalition managed to get a few misguided legislators, the most prominent of whom was Senator Kelly Ayotte (R-NH), to write letters to the FDA urging that it consider allowing ANPs to be made available through single patient IND/expanded access to their constituents, the letters were fairly wishy-washy. Moreover, the Change.gov petition to the White House response to a We The People online petition to have the FDA allow Elisha Cohen access to ANPs through compassionate use exemption resulted in a response that, boiled down to it essence, said that it’s the FDA’s job to make such decisions, and let the FDA do its job, along with links to various FDA web pages with information about investigational drugs and information about how the FDA could be contacted. It was a shockingly reasonable response.

One rationale reported in Szabo’s article seems to be that by allowing ANPs to be used but excluding Burzynski from having anything to do with administering them other than producing them, in essence, relegating him to the role of a drug manufacturer, useful data might be obtained and patients protected while obtaining that useful data. This is utter nonsense. As Howard Ozer is quoted in Szabo’s article:

“This is a cop-out,” says Ozer, director of the University of Illinois Cancer Center, who studied Burzynski’s research results in the 1990s.

“Because it can be toxic and cause life-threatening sodium problems, patients (who take antineoplastons) are at risk and could die,” Ozer says.

The scientific community will learn nothing by giving these patients antineoplastons, because there will be no comparison group, Ozer says. Any doctor who agrees to give antineoplastons could be biased in favor of them, which could skew the results.

Exactly. As Dr. Peter Adamson points out in the article, after 37 years, if antineoplastons were the wonder drugs that Burzynski claims them to be, scientists would know it by now. ANPs aren’t wonder drugs. There isn’t even any evidence that they’re better than standard-of-care, as dismal as that is for DIPG.

It is possible that one of the Senators or other legislators did indeed pressure the FDA, leading the relevant enforcement officials to come up with this decision in order to get them off their backs without actually doing anything. They could credibly say, “Hey, we offered compassionate use, but I’m sure you’ll agree that, given his history, we can’t let Burzynski be the one to administer the ANPs on compassionate use. Look at his history of playing fast and loose with IRBs and not obeying the rules with respect to INDs.” This might even sound convincing and seem clever, which is why I rather suspect that Dr. Henry Friedman is right when he says:

“It will deflect criticism from anybody who says the FDA is unilaterally denying dying patients something that could help them,” says Friedman, deputy director of the Preston Robert Tisch Brain Tumor Center at Duke University in North Carolina, who also reviewed Burzynski’s studies in the 1990s. “It will get FDA off the hook.”

That, I believe, is exactly why the FDA did it, not to help dying children. Unfortunately, the consequences of the FDA’s decision are likely to be disastrous. Long-suffering families will have false hope extended to them once again, only to find out that it’s a useless offer. In addition to continuing to scramble to raise money, they’ll scramble to find oncologists willing to do the not-inconsiderable work to get a single-patient IND approved and administer ANPs, something few, if any of them, are likely to succeed at. The families don’t know it yet, but what the FDA has done will only add to their misery. Indeed, I’ve already seen reports that patients have contacted “dozens” of pediatric oncologists looking for one who will administer ANPs, and, given that the number of pediatric oncologists in the US is small, a significant proportion of them are likely to be contacted.

Meanwhile, Burzynski gets a propaganda victory, thanks to the FDA’s failure to enforce its own standards, and alt-med proponents get another conspiracy theory to add to the list of conspiracy theories surrounding Burzynski already.

Posted in: Cancer, Clinical Trials, Politics and Regulation

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

  1. goodnightirene says:

    I don’t see it so much as a “cave”, rather an unhappy compromise of sorts. The true believers are not persuaded by your lengthy and detailed scientific reports on SB, and the FDA cannot change their minds, so they are making an effort to seem responsive to desperate people. The FDA is as much a victim of this ignorance as are the parents of the children with cancer and other patients of SB who have been misled by SB.

    In an ideal world the FDA would not do this, as science would prevail, but we all know that policy is deeply affected by ideology/politics.

    Not all parents of ill children respond this way, and while my heart goes out to all families with ill children, my deepest respect is reserved for those who face such an illness with reason and the dignity it brings to a sad and heartbreaking situation.

    1. David Gorski says:

      I don’t see it so much as a “cave”, rather an unhappy compromise of sorts.

      You say “unhappy compromise,” I say “cave.” In the end, I think that my characterization is more accurate. Basically, the FDA washed its hands of the issue and foisted it off onto (mostly) the pediatric oncology community. Worse, it makes the FDA look craven, and it won’t get the Burzynski drones off its back. They’ll proclaim that this is a conspiracy in which the FDA “knows that ANPs work” but has it in so much for Burzynski that it won’t let him prove it. Basically, the FDA gets the worst of both worlds this way.

      1. Frederick says:

        I agree with you, they open the door just a little, so they will take that as proof they are right.

        I wonder if the FDA did it hoping that, since they need a outsiders to supervised the “treatment” ( it is not a treatment of course ), it will make people see it is a fraud. Because most ethical doctor, and rational ones will not agree to give that scam to people. And they will be turn down often by oncologist who knows that it does not work. Od course this is naive, desperate people don’t gave up easily, ( we can understand that) and there is always Doctors with less ethic or just believe in letting people try bad idea.
        Good article By the way, and also you letters to David lauzers. Excellent response, it is hard but it has to be done, and it show how much you care.

        1. Michele says:

          I say ‘punt.’ They took the most cowardly of all possible courses here and punted their responsibility to protect patients–even from themselves–onto community oncologists who are now going to be under extreme and unfair pressure to administer a therapy that the FDA knows full well should not be available under any circumstances.

          What a tragic, FDA-enabled waste of time for oncologists, clinical administrators and IRB personnel to go through the motions of approving this for patients who need real therapy and need it urgently.

          1. David Gorski says:

            Yep. The FDA punted. It passed the buck. And pediatric oncologists (of which there are not very many, given how relatively rare pediatric malignancies, fortunately, are) will pay the price in harassment and phone calls.

  2. stanmrak says:

    Are folks here just now discovering what a corrupt, self-serving and misguided organization the FDA is? People in the CAM community have been saying this for decades.

    1. WilliamLawrenceUtridge says:

      CAM promoters are angry because the FDA is doing its job. Dr. Gorski is angry because it is not.

      A slight distinction.

      1. David Gorski says:

        Yeah, it cracks me up that stanmrak would think that my complaints about the FDA in this post have anything to do with quacks’ complaints about the FDA. :-)

      2. stanmrak says:

        Missed the point entirely. It doesn’t matter which way the FDA rules – they look after themselves first and are not to be trusted one way or the other.

        1. WilliamLawrenceUtridge says:

          Considering this is pretty much a lose-lose for everyone (Cohen doesn’t get treatment in anything close to a satisfying manner, ANP doesn’t get any sort of meaningful testing, the FDA looks like an obscurantist point-dodging douchebag, skeptics don’t get Burzynski shut down or his protocol disproven for once and for all), you seem to rather miss the point.

          In fact, the only real winner here seems to be Burzynski. Sure, he doesn’t get to sell to these eight kids, but the rest of his money machine – sorry, his clinical trials that he charges tens of thousands of dollars in “case management fees” to deliver high-dose conventional chemotherapy plus piss extracts with enough sodium to kill someone – gets to keep churning.

          Yeah, it would have been nice if the FDA took an actual stance instead of this “pleases nobody” middle ground. They didn’t. Everyone suffers.

          The head of the FDA should always be an experienced cancer researcher who is on his/her last job before retirement, so they always get to go out in a blaze of glory.

    2. rxpert says:

      You missed the point of this entirely.

  3. kevin says:

    What’s worse is even if the treatment does get administered, and when it doesn’t work, people will just claim the FDA took too long and the treatment happened too late to be effective.

    I ran into a Burzynski-truther, a father of my friend, the other month, and it is amazing the passion and zeal that he fought for this man with, even though he, nor any of his family members, have cancer. People want so badly to believe that the government is full of lies and misleading them. After getting riled up about Burzynski, he then showed me his bottles of glutathione and coffee bean extract and asked for my thoughts on their efficacy….

  4. Windriven says:

    “Can anyone figure out why I can’t make up my mind whether this decision, if what the Cohens say is true, is stunningly cynical or stunningly naïve on the part of the FDA?”

    I suspect it isn’t quite either cynicism or naïveté. More like cowardice. FDA doesn’t want the heat of denying the hope for a miracle from dying children. It also doesn’t want to allow Burzynski to muddle the record further by his inept record keeping. So, create a sort of Catch-22 where FDA says, ‘sure you can have ANPs – just use an independent oncologist’ while few oncologists and their IRBs will be willing to sign on. FDA gets to smirk and say, ‘we did our part.’ So yeah, cynical is probably right.

    On a positive note, presuming a few oncologists get sucked in, one hopes that their preumably accurate and detailed record keeping will drive a stake through the heart of ANPs.

  5. Frederick says:

    Funny how some peoples can in one hand, accuse the FDA, “big pharma” and Doctors to be just in for the money, and corrupted, and on the other hand, defend a Quack selling “Doctor” ( He do not deserve that title) that charge hundred of thousand of dollars, (And got a 6 millions dollars house ) for a freaking thing that cannot possibly work. Double standard, or just delusion?

    1. WilliamLawrenceUtridge says:

      One of my favourite standard replies is to point out that very double-standard.

  6. PMoran says:

    “We have to believe that there is hope of someday succeeding”

    In what? Such a pessimistic position suggests unrealistic objectives.

    I suppose the following will be classed as an attack on “tone” rather than a plea for smarter strategy, but the “our way or no way” approach to cancer quackery has historically always aroused passions, encouraged suspicion and stirred up human rights opposition.

    People just cannot understand that while there is some small possibility that a cancer treatment might help (and a testimonial or two will do that in very many minds), they might not be entitled to try the treatment at their own expense and risk when in desperate straits. (It is a little different when a child is involved and highly effective conventional methods exist.)

    I find it equally galling that a slimy person like B might seem to be supported or encouraged, but we either undertake the Sisyphean — no, not that — the impossible task of raising essentially whole populations to our level of scientific sophistication and conviction, or we remove some of the false glamour and legend surrounding these methods by being a tad permissive regarding them when people have nothing much to lose. Human behaviour, we know, can be paradoxical.

    So I think there is nothing much wrong with the FDA saying, “We don’t think these methods work, but for the sake of compassion we will not stand in the way of those who wish so desperately to use them. Those who do so should understand the following risks — .”

    What we should ensure, if at all possible , is that such patients are well-documented as having progressive, invasive cancer before starting B’s treatment, to the standard that would be usual when being entered into a conventional study. The expected outcomes of a few such highly publicised cases will then, (sadly), be unlikely to be misleading to others. It would soon get spread around if eight such patients all had bad outcomes, as is likely .

    1. David Gorski says:

      So I think there is nothing much wrong with the FDA saying, “We don’t think these methods work, but for the sake of compassion we will not stand in the way of those who wish so desperately to use them. Those who do so should understand the following risks — .”

      Really? I thought you familiar with Burzynski. Where does it end? How about laetrile, which you’ve correctly lambasted as quackery? What about Robert O. Young? Hoxsey therapy? Gerson therapy? Gonzalez protocol?

      Should the public be allowed to have access to them, too?

      And if you don’t think the public should have access to these therapies outside the auspices of a clinical trial, then why ANPs, which I’ve come to realize really fall into a similar category, although Burzynski is better at slapping a veneer of science on it? What is the dividing line? Or should there be one? Should any patient be able to pursue any quackery he likes, with the FDA’s shrugging its shoulders and getting out of the way? Yes or no, Peter. Yes or no?

      What we should ensure, if at all possible , is that such patients are well-documented as having progressive, invasive cancer before starting B’s treatment, to the standard that would be usual when being entered into a conventional study. The expected outcomes of a few such highly publicised cases will then, (sadly), be unlikely to be misleading to others. It would soon get spread around if eight such patients all had bad outcomes, as is likely .

      How can you be so naive after all these years? You know as well as I do that the deaths of cancer patients who rely on alternative treatments are often never reported and therefore rarely, at best, register with the public. On those rare occasions when they do register (e.g., Amelia Saunders), we hear excuses about the patient starting too late or the parents having made the decision to take the patient off ANPs.) For example, there was also the example of Burzynski showing up on the Sally Jesse Raphael Show back in the 1980s with all these “miracle” patients. A few years later, another show followed up on them and found that they were all either dead or were dying of a recurrence. Only one of them had turned out to have indolent disease and was still around. I seem to recall that you yourself have documented on your own website how patient testimonials for alt-med cancer cures, once on the web, never go away, even after the patient dies. It’s why this website exists:

      http://theotherburzynskipatientgroup.wordpress.com

      1. PMoran says:

        David: “Really? I thought you familiar with Burzynski. Where does it end? How about laetrile, which you’ve correctly lambasted as quackery? What about Robert O. Young? Hoxsey therapy? Gerson therapy? Gonzalez protocol?

        Should the public be allowed to have access to them, too?”
        ========================
        You know I am familiar with B, and it is part of MY point that the public already has almost unlimited access to these other methods in one form or another.

        Trying to stop B totally would affect one tiny form of cancer quackery (mainly for brain cancers) out of dozens of others, and this at the expense of massive publicity for his “cause” within alternative circles and cancer circles generally, also puzzlement in many as to why we would feel it necessary to do so. If as successful as you seem to wish, he would also simply move to the Bahamas (like Burton of IAT infamy) or elsewhere, anyway.

        Furthermore, in the extremely unlikely event that a superhuman effort eventually eliminated all those forms of cancer quackery one by one, there would still be claims circulating about miraculous diets, supplements, herbs or minerals, mind-body and religious or quasi-religious practices. These would be nearly equal potential for harm in those so motivated, even while other, newer forms of quackery were cropping up all the time.

        So massive efforts to suppress CAM for cancer may have little effect, while simply provoking more passion surrounding them and mistrust. And this state of affairs will continue so long as the mainstream has no complete answer to cancer, and the population contains a body of persons prepared to gamble on other methods — so probably for a long time .

        Do you see any worth to this viewpoint? If you cannot, and are, as it seems, pursuing rather unrealistic objectives then there is not much more to say.

        You also know that I am familiar with the other matters you mention. I was assuming that it would be possible to keep track of the fate of the known cases under discussion so that people like us could ensure that how they fared became public knowledge. I suppose that might not be true for privacy reasons — even so, any misrepresentations regarding their fate would add only marginally add to those Burzinski is already exploiting, so that this might not override compassionate considerations in some minds.

        1. Andrey Pavlov says:

          Peter, I’m reading this as saying that the task is insurmountable and therefore shouldn’t be attempted. It will generate more harm than good along the way and inevitably lead to a Pyrrhic victory at best.

          What am I missing?

          1. PMoran says:

            “Peter, I’m reading this as saying that the task is insurmountable and therefore shouldn’t be attempted.”

            Again, what do you mean by “the task”? If you have set yourself the objective that cancer sufferers will meekly allow themselves to die of cancer without trying other things when our methods have failed then I am asking, “have you thought this through?” Also, “how do you see this coming about?” and “when will it start to happen, now that we have not a lot to show from fifty years or more of the most “curmudgeonly” medical opposition to dubious cancer treatments?”.

            I am still thinking matters through myself, but a preliminary idea is anything we do or say as a profession beyond providing a sound scientific opinion, along with an impression of the degree of certainty involved, and as far as possible then permitting cancer sufferers to make their own decisions, can do more harm than good.

            The implied objective is one of trying to make sure that people are coming to minimal harm from cancer quackery, to the degree that that is possible under present conditions. It looks towards the restoration of mutual trust, rather than approaches that have not proved very effective so far, such as attacks upon the quacks, and various attempts at legal prohibitions. (I don’t mean to say that these don’t have some place.)

            On this approach, once we have made it clear that we are “almost certain” that B’s treatment does not work (as David says above) we have done 95% of our duty and of what is practical and realistic. It is then for the patient and relatives to decide where they are prepared to invest their trust and other resources.

            Yet we can still undermine trust in our opinion in a flash. For example few lay persons will understand it if we seem to be urging the FDA to obstruct people with otherwise no hope for from trying other treatments at their own discretion, expense and risk. While that may not quite the message David intends, many people will not read past a headline above, which conveys just that message.

            We recently discussed how seeming to be presenting overly romantic views of conventional capabilities can have the reverse effect to that desired.

            1. Andrey Pavlov says:

              Again, what do you mean by “the task”?

              I don’t know – whatever it is that you are referring to. I was using it as the generic term to refer to the topic of your argument. I was just trying to parse what it is you think we should do in general before getting lost in the specifics again.

              If you have set yourself the objective that cancer sufferers will meekly allow themselves to die of cancer without trying other things when our methods have failed then I am asking, “have you thought this through?”

              The fact that you can even consider that as even a guess at what my (or others’) objective could be is telling me that one or both of us is not communicating or understanding well at all.

              No, the objective is to be as accurately informative as possible, to show a waste of time and money for what it is and why, to use what we know about placebo effects and the perceived efficacy of CAM (the patience, dedicated listening time, counseling time, ect) to the benefit of ourselves and our patients, and yes to also help patients (and family) be OK with death. One of the 3 fellowships I am strongly considering is in palliative care. I believe that there are things in life worse than death and we are in a unique position to inflict that on people. I also believe that by far the most caring and humane thing to do is not to just keep throwing $hit at the wall and hoping it sticks, all so that the patient and family feel like they are “doing something” in their darkest hours, but to strive to make it OK for them to die. Yes, it is a much more difficult task, yes it does not always work, yes some patients (and families, but my first duty is to my patient) want to try absolutely everything and for them what I would perceive as spinning their wheels and wasting time and money is not. For those patients we should still strive to help them, kindly and compassionately. That does not mean we need to ever endorse CAM or do anything but discuss its lack of efficacy. That is no different than discussions about futility of care. You see Peter, the point is to have a uniformity in the approach. In the same way as having a discussion about why a 2nd bone marrow transplant is not advisable, or how ceasing CPR is the right thing to do, discussing how acupuncture or homeopathy or anything else is not advisable is perfectly reasonable. The only differences is that there are times when a bone marrow transplant is scientifically and medically reasonable to recommend. There is not the same for CAM. But the negative side of both are there and can both be discussed in the same manner and with the same intent. I’m not going to recommend that 2nd bone marrow transplant if the pain, cost, complications, and likelihood of success don’t make it worthwhile. I see no difference in approaching the use of CAM.

              We are also in a unique position to sway a patient and family in how they view death and dying (and pain, and grief, and difficulty). Throwing up our hands and just not saying anything, or pretending that “sure it may help, probably not, but what’s the harm” is doing a disservice to our patients. But in the same way I can’t force my patient to stop smoking, I’m not going to force my patient to stop getting acupuncture. That doesn’t mean I won’t try and dissuade (as possible) my patient from smoking… nor dissuade them from ditching acupuncture. Yes, obviously the risk:benefit is different for the two, but in both cases the risks outweigh the benefits (but both have benefits!). My patient who is heavily comorbid, having extreme difficulty coping with medical and social circumstances, and is a smoker is probably not in a state for me to press too hard on the smoking cessation. I may even forgo discussing it at all until a better time; it’s a matter of picking battles in the context of the patient for an end goal of improved health. The same may be for my patient who uses acupuncture. He may not be in a stable enough place for me to push hard to cease the useless (and potentially harmful) activity. It has benefits in the same way smoking has benefits for my other patient. And yes, since the risks are definitely a fair bit lower for acupuncture how high on my priority list and how hard I push it will vary accordingly!

              It is all about having a uniform standard and platform. That doesn’t equate to saying the exact same things in the exact same manner in all given contexts.

              Also, “how do you see this coming about?”

              I see it coming about slowly. Through consistent and persistent efforts at education and explanation of the relevant topics. The same way I see the eventual death of religion. Ideas spread and good ideas win. Keep having and presenting good ideas and let it take its course. I can’t (and wouldn’t if I could) force people at gunpoint.

              The trick is that if you are to stalwart people dig in their heels. However if you waffle they pounce on your uncertainty. It is ultimately a zero sum game. Pseudoscientists and theists win debates by sounding certain, not based on the merits of their arguments. In the case of damned if you do and damned if you don’t, I (and I believe the others here) would argue that doing is better than not. Those that we lose in the middle because they very our certainty as overweening are an inevitability. We we lose others in a different middle with a different tack. The question is, in which way do we lose more? I don’t think that is answered nor easily answerable. We apparently differ in opinion – I think we will lose many more in the long term by being anything but stalwart and confident.

              when will it start to happen, now that we have not a lot to show from fifty years or more of the most “curmudgeonly” medical opposition to dubious cancer treatments?”.

              I disagree with your characterization here. You are implicitly arguing that our tack is the same one that has been ongoing for 50 years and we’re obviously failing, ergo time to change tack. Yes, certain components – most notably the stalwartness – are shared. But the overall tack is otherwise fundamentally different. It is adapting to an era of information access never before even imagined. I’d say that there is not enough time to actually empirically evaluate our tack. But the analogous situations with theists and conspiracy theorists show promise and lend credibility. The fact that this site is becoming ever more popular, garnering the attention of both academia (e.g. Cochrane) and media (e.g. Dr. Novella on Dr. Oz’s show) is further evidence. The fact that groups are organizing on campuses for the first time to fight what we call quackademia, that the Friends of Science in Medicine and the SfSBM exist (and that the FSM is gaining credibility in the media and used as a reference in popular journalism on relevant topics) are more evidence.

              along with an impression of the degree of certainty involved,

              Indeed. The difference is that you seem to think our language of certainty is too certain for your tastes. We disagree. It is open to disagreement both ways. Nobody pretends it is a settled fact how to communicate precisely how unlikely or likely something is. Numbers are great, but that is not what most people understand and can internalize. You have a 1 in 1,000 chance of developing [x]. What does that mean to a patient? It becomes subjective how to convey that. Your consistent complaint has been that our word choice is, in your subjective opinion, too certain or too stalwart. Fine, but that is not the empirical argument you pretend it is.

              we have done 95% of our duty and of what is practical and realistic. It is then for the patient and relatives to decide where they are prepared to invest their trust and other resources.

              Sure. But I argue that the remaining 5% is worth fighting for as well. And that includes “above and beyond” steps like fighting to shut B down. Fighting to prevent rank quackery from being lionized by legislation. Fighting to prevent the (credulous) teaching of it in universities.

              You wouldn’t make the same argument about engineering standards. You wouldn’t say the ASME is 95% done by simply putting out a technical paper on the safety limitation of boilers and then let the consumers and building contractors decide what to do with that. You would see it as perfectly reasonable to actually make it law that those minimum safety standards be met.

              It is messier and more difficult to do so in medicine and we are much more likely to misstep than the ASME. But that doesn’t mean why shouldn’t be trying to do it.

              Yet we can still undermine trust in our opinion in a flash. For example few lay persons will understand it if we seem to be urging the FDA to obstruct people with otherwise no hope for from trying other treatments at their own discretion, expense and risk.

              Sure. But you act like that is somehow unique to our profession. It is certainly more pronounced in our profession. But I have talked with people from all walks of life you say the same thing about engineering regulations or environmental regulations or safety regulations. There are people who mistrust OSHA because they feel it is undue governmental oversight so that an industry can make money selling unnecessary safety equipment. We don’t pander to them and we shouldn’t pander to their analogues in medicine. I mean, after all, why shouldn’t a family be allowed to buy a sub-standard boiler for their building at their own discretion, expense, and risk?

              Where to reasonably set that minimum and how to make it enforceable is always up for debate. It is less debatable in engineering since that is much more dry and clear cut. But their are still huge debates about it. That doesn’t mean we stop the debate and give it a pass; neither in medicine.

              While that may not quite the message David intends, many people will not read past a headline above, which conveys just that message.

              “Government imposes new safety regulation that will cost factories millions and lose thousands of jobs.”

              “New regulation set to save lives of hundreds of factory workers”

              Most people also won’t read past those headlines either. But that’s not the point. You’re not going to win your battle in the headline. Your argument is… what? That a “nicer” headline would be better to rope people into reading the article and thus be convinced? That seems a bit naive to me.

              We recently discussed how seeming to be presenting overly romantic views of conventional capabilities can have the reverse effect to that desired.

              Yes, but that doesn’t tell us what the outcome on the whole is. Or in the long term. It doesn’t signal a need to completely change tack. It signals a need to look a little more closely, pay more attention, and perhaps tweak things a bit. Perhaps more evidence will come to bear that adds to it and thus really does force a change of tack. But so far, I haven’t seen it.

              1. PMoran says:

                I can’t regard that response as well-thought-through, Andrey. Here are two matters that stand out.

                You were affronted at the suggestion that you were expecting cancer patients to meekly accept death rather than use CAM when conventional treatments have failed .

                Yet a little later you propose just that: — ( “— how they view death and dying —”) — as one of the solutions to the problem of CAM use by cancer patients.

                In addition to this bewildering inconsistency, you state that you are in a “unique position” to help people face death.

                How, exactly ? What possible support does the emotional barrenness of science, and the meaninglessness that it has so far found for human existence, offer a dying patient?

                We scientists like to affect that we derive solace in the grandeur and mysteries of the universe, but that may merely demonstrate the universality and depth of certain human needs, also that scientists are as prone as anyone else to fulfil them with make-believe and self-deception.

                2. You state : “The difference is that you seem to think our language of certainty is too certain for your tastes.” when I have explicitly supported David’s statement that we can be “almost certain” on the present evidence that B’s treatment doesn’t “work” (meaning “have any worthwhile favorable effect upon cancer”).

                The problem we have is that even that correct but maximumly sustainable statement is an important concession for the at least fifty per cent of the public that is not sure how well they can trust our opinions to begin with. They will accordingly adjust the possibilities upwards, easily reaching a ball-park that is of interest to otherwise doomed people, and who are also under other pressures from their own family and tribal groups. (That “almost certain” also helps explain the FDA’s somewhat cautious behaviour).

                Science, no matter how brilliant we may be at it, does not offer clear-cut solutions to such human problems.

                I dare to suggest that we can blunder around in these scenarios with a sense of utter moral and scientific righteousness, egged on by our admirers, while possibly just making matters worse, helping with our rhetoric if not our actions to feed the passions and the mistrust of fresh generations of cancer sufferers and their relatives.

                That is what your ill-judged call for “fighting to shut B down” risks, at this stage of proceedings.

                It has always done so in the past. Political and legislative solutions to CAM problems are mainly only practical when you have either lot of patient complaints or a lot of dead bodies. It is not a good strategy i.e. conducive to mutual trust for us doctors to be at forefront of efforts to obstruct CAM use in every which way we can. Our unwritten contract with society is as an adviser, not a controller.

              2. Harriet Hall says:

                Peter,
                Several of us have repeatedly asked you to write a guest article explaining your ideas more clearly and specifying exactly what you think we “should” be doing instead of what you think we “are” doing. It would take less of your time in the long run and would do more to communicate with us than continuing your usual comments. I do think you have something important to say, but the way you have been articulating it has generated more heat than light and has left your readers confused.

              3. MadisonMD says:

                … you were expecting cancer patients to meekly accept death rather than use CAM when conventional treatments have failed .

                If you delete ‘meekly’ then that is exactly what I expect. (Meekly plays on emotion).

                It is a mercy to be honest with cancer patients, to tell the truth to people who then then use this to plan a limited future. Yet helping a dying patient to accept death is a mercy. It is a dishonest omission to avoid speaking the truth with someone suffering from incurable cancer. Honesty is the fundamental basis of palliative care and the reason why many dying cancer patients end their lives at home or hospice peacefully surrounded by the family, instead of on a ventilator in the ICU surrounded by doctors and nurses with paddles and needles. I deal with this regularly.

              4. Andrey Pavlov says:

                I agree with Dr. Hall. You’ve once again offered nothing new, insightful, nor substantive. Your best comment is picking a nit at what you feel is some substantive contradiction in my thoughts on death and dying. MadisonMD said it well and probably better than I. But the fact that you are implying that we as physicians are not in a unique position to help patients and families face death undercuts your entire thesis. I can’t tell if you are just using that as a rhetorical tack or if you are genuinely clueless as to how using science based medicine and evidence in the context of a dying patient can indeed help them face it. To put it bluntly, you’re either disingenuous or profoundly wrong. Palliative care exists as a speciality for a reason – and somehow it isn’t staffed by CAM practitioners and priests, but actual physicians who use science to inform their practice.

                I feel like I may be finally starting to understand a bit of what you are trying to say. And if that is the case, I am confident that you are wrong.

                So we can leave it at that. I’m done wasting my time dancing circles with you. It has proven fruitless to the extreme and that should be quite telling to you. But you seem to have the “lone maverick” attitude about it, so do as you please. I shan’t bother responding to anything else you write unless it is a fully fleshed out guest post. For all the time we’ve spent dueling, you should be able to put something together. Your continued failure to do so is also telling in and of itself.

      2. Earthman says:

        Followed the link to the other Burzynski site, and my is it grim reading. There is a picture of SB with a patient and he is dressed in a lab coat. It is surely easy to spot a quack doctor when they dress as a lab technician. Also, a telling part of the account of the patient on the opening page is that their first visit to the SB clinic was to see the doctors and the ‘financial team’, wow what a give away.

    2. Andrey Pavlov says:

      Jesus said the poor will always be with us. Peter says the scientifically unsophisticated will always be with us.

      Well, time to pack up our bags. We’ll never, not even in our great- great-great- great-great- great-great- great-great- great-great- great-great- great-great- great-great- great-great- great-great- great-great- great-grandchildren’s lives have anything but a majority of unsophisticated lay people driving CAM use.

      Well, I’m convinced. Come on Dr. Gorski. Time for us to close up shop and use the extra time to get our Integrative Medicine board certs.

      1. David Gorski says:

        Indeed. Sadly, we’ll have to wait until at least November, because the demand to sit for the “integrative medicine” boards was so high. We might not be able to do it until 2015, but at least that’ll give us time to study.

        Maybe I’ll even contact Burzynski and ask him if he’d let me be one of the docs to administer ANPs to one of the eight children petitioning the FDA. Why not? If you can’t beat ‘em, join ‘em.

        1. Andrey Pavlov says:

          I’m sure they would make some sort of special consideration. Having a notable skeptic like you join their ranks would be a huge feather in their cap! And then you can hobnob with the crème de la crème of the integrative medicine elite. You and Andrew Weil, Deepak Chopra, and Dr. Oz can sit on a yacht, dining on only the finest supplements. Oh I can imagine it now… only the most pristine green coffee bean extract, hand pressed by Honduran virgins, while a Reiki master channels quantum energy into each capsule.

          Ah, the good life. If only we’d stop being so needlessly curmudgeonly perhaps we too could live it.

      2. PMoran says:

        Well, Andrey, once again having a necessarily minimal acquaintance with a subject has not stopped you from making non-contributory comment. Nor has the fact that present strategies don’t seem to be producing desired results, as Dr Gorski laments.

        In the perhaps fond hope of advancing constructive dialogue, I will move on and state that anything we do or say as a profession beyond providing sound scientific opinion, along with an impression of the degree of certainty involved, so that people are respected and as far as possible permitted to make their own decisions on health matters, can do more harm than good.

        It doesn’t matter how scientifically and morally correct we think we are. In fact the more overbearing we are in these respects the more we are likely to provoke the responses such as “if you are so smart you cure my cancer!” It is unfair and unrealistic to expect seriously ill people and their relatives to toe scientific lines that are devised to keep science strong and accurate ictated by default necessity of serious scepticism.

        “ANPs almost certainly don’t work –” That almost

        It can also erode confidence in our judgments if we seem to be inexplicably (to them) opposing actions that may have only a remote chance of benefit, but which don’t harm anyone else whichever way things turn out i.e. are none of our business, once we have offered our opinion.

        You wrongly assume that I amn advising total passivity. That is not so. I am trying to ensure that our words count.

        stated . We need to be sure that our obstructiveness is not in weird way lending

        he maturity and lack of bias in our judgements. It can arouse counterproductive passions as do many attempts to legislate against quackery (make sure you have plenty of actual bodies) .It is not smart to look at cancer quackery as a matter of us versus “a majority of unsophisticated lay people”. It would make more sense to ask why a scientifically unsophisticated public is not deferring to our expert opinion.

        That smacks of the hubris and blundering ignorance that
        In the interests of more mature dialogue, I will move on and state that anything we do or say as a profession beyond providing sound scientific opinion, along with an impression of the degree of certainty involved, so that people can as far as possible be permitted to make their own decisions on health matters, can do more harm than good.

        From then on everything depends upon where people are prepared to invest their trust, and any false steps will erode confidence in the maturity and unbiased nature of our judgement. They also can arouse counterproductive passions, as do many attempts to suppress “quackery” through legislation ( always make sure you have plenty of actual bodies!) . .

        You are a perfect example of what I mean. In accord with the extremely poorly supported notion that more public education is the answer, You cast the present problem as us versus a “majority of unsophisticated lay people”? “If you are so smart, why are YOU unable to stop my cancer”, will be the inevitable response.

        That is not meant to be proof that any CAM they have chosen works — it should be read as a signal that you are carrying quite the wrong understanding of the situation into the dialogue, and that it is probably already too late to restore lost credibility.

        this as

        1. PMoran says:

          I accidentally sent an unfinished message I had decided not to send, as being too inflammatory in relation to a matter that requires more sober thought.

          My apologies to Andrey and to everyone for my clumsiness.. I will send a better response to Andrey’s more reasonable question.

  7. stanmrak says:

    As with all things in life, there is another side to the story, equally valid to the people it affects….

    http://articles.mercola.com/sites/articles/archive/2014/03/25/cancer-treatment-antineoplastons.aspx?e_cid=20140325Z1_DNL_art_1&et_cid=DM41444&et_rid=465374267

  8. kevin says:

    Woke up to this headline from Dr. Mercola today – “Why Are Terminal Patients Being Blocked from Making Their Own Decisions?” Masquerading under the free choice argument is getting old.

    http://articles.mercola.com/sites/articles/archive/2014/03/25/cancer-treatment-antineoplastons.aspx?e_cid=20140325Z1_DNL_art_1&utm_source=dnl&utm_medium=email&utm_content=art1&utm_campaign=20140325Z1&et_cid=DM41444&et_rid=465126618

    1. David Gorski says:

      It’s also a reprint of an article Mercola posted two weeks ago, which is hilarious because this was before the FDA decision. Consequently, there is no mention that the FDA is actually going to let these children receive ANPs, as I discussed in my post above. In the meantime:

      http://scienceblogs.com/insolence/2014/03/11/ric-schiff-attacks-the-fda-on-mercola-com/

  9. lilady says:

    The last update on Elisha Cohen was posted on February 4th, from Columbia Hospital, NYC…and it was ominous:

    http://www.youcaring.com/medical-fundraiser/help-raphael-elisha-meir-ben-devorah-cohen/104108

    “Dear Friends,

    Much has happened since we last posted an update. The Cohen family has relocated to New York where Rephael Elisha is receiving care from specialists at Columbia University. They are so grateful for all the kindness and support that has been given to them there.

    Please continue to have Rephael Elisha Meir ben Devorah in your prayers. He is currently in the hospital in critical condition.

    Here is an update that Rabbi Cohen wrote at the beginning of the week:
    We’ve been in the PICU all last week recovering from a seizure. MRI done on Friday and it was briefly revealed to us that the disease has gotten worse. We haven’t reviewed the scans with our doctor yet so we don’t know to what extent.

    That will be this coming Monday. Meanwhile we have been moved from the PICU to the oncology floor where he continues to have seizures.

    It’s scary from all sides.

    G-d willing the Doctors will still be willing to implement the original plan that we came to Columbia in the first place.

    Columbia does have an awesome integrated staff with Alternative medicine which we are very excited about.”

    Frankly, I have my doubts that any pediatric oncologist who is affiliated with Columbia (Columbia Presbyterian Hospital or Columbia University Medical Center), would be willing to put this young boy, who is diagnosed with a medulla blastoma, through a course of ANP treatments.

  10. WilliamLawrenceUtridge says:

    Do you know what would be nice to see out of the FDA? If they were willing to, rather than namby-pamby “it might work if we can find someone to do it” mealy-mouthing over an issue like this, instead taking the bull by the horns and actually running a clinical trial on it. They could answer the question if they were the ones to set up a protocol, put in control groups and follow patients as they…well…gradually died of untreated cancer I guess. Or succumbed as Burzynski doses them with questionable amounts of chemotherapy in even more questionable combinations.

    1. MadisonMD says:

      @WLU
      The FDA never has run or sponsored a clinical trial. In fact, I doubt this could be done legally, because actually performing research on cancer is the purview of another branch of the Department of Health and Human Services, namely NCI/NIH. Moreover what you propose was done by the NCI 20 years ago, with the experience documented in The Cancer Letter in 1998 and results published in 1999.

      Even were it legal, what you propose is not practical. If the FDA/NCI were to ignore the ethical principle of equipoise and actually start a RCT, they would not get buy-in from investigators who actually run trials or doctors who actually enroll them (see quote from Rich Schilsky in Cancer Letter link–basically he says, yeah show us the promising data and then we will run a trial–which sounds pretty damn reasonable to me). Physicians don’t enroll patients in trials of therapies or changes in practice that they believe not helpful or detrimental to their patients. You need broad buy-in from the medical community. You could only get it if Burzynski releases the results on the thousands and thousands of patients he has treated.

      Even if such a trial were done, and was negative, it wouldn’t end there. Burzynski could say the trial was done incorrectly, drugs given wrong, etc. Hold on a second, this is exactly what he said when the NCI trial was published.

      Been there, done that.

      1. WilliamLawrenceUtridge says:

        Yeah, I know, but a man can dream.

  11. lilady says:

    Test post.

  12. Ronald says:

    What baffles me is the fact that ‘modern medicine’ is allowed to use dangerous toxins and toxic therapies (for instance ‘chemo therapy’) under the cover of ‘science’, without a problem, while, at the same time attacking ‘alternative therapies’ which are by no means toxic or dangerous for ones health. Also, the placebo effect applies to ALL therapies, allopathic or not, and this is a great concern for modern medicine too (I hope you see the irony in this too).

    Please people, do yourself a favor and read up on, for instance, the history of chemo therapy and ask yourself a few questions. If this simplistic approach is the best science has to offer, that should start to make you think and wonder, no? In my opinion, after studying the subject of ‘illness’ by myself, for several years, we are mislead by the medical establishment, who, to my surprise, have no trouble selling their poison to people in (health) trouble, in the meantime calling everything they don’t approve with ‘quackery’. This situation would be funny, was it not that it’s so sickening…

    1. David Gorski says:

      Also, the placebo effect applies to ALL therapies, allopathic or not, and this is a great concern for modern medicine too (I hope you see the irony in this too).

      No one has ever shown objective improvements in progression free or overall survival due to placebo effect, or any objective tumor shrinkage due to placebo effects.

      Please people, do yourself a favor and read up on, for instance, the history of chemo therapy and ask yourself a few questions. If this simplistic approach is the best science has to offer, that should start to make you think and wonder, no?

      You mean the way I did a few months ago?

      http://www.sciencebasedmedicine.org/chemotherapy-doesnt-work-not-so-fast-a-lesson-from-history/

    2. weing says:

      “What baffles me is the fact that ‘modern medicine’ is allowed to use dangerous toxins and toxic therapies (for instance ‘chemo therapy’) under the cover of ‘science’, without a problem,”
      Without a problem? Really? I don’t think you have studied this at all. Chemotherapy is not given to healthy people. Have you studied CAM enough to know that besides being useless to the ill, it can be dangerous?

    3. Dave says:

      The posters here know an awful lot about the history of chemotherapy.

      Cancer cells are distinguished from normal cells by unremitting cell division and growth. The older chemothaerapy agents worked by killing cells as they divided. Unfortunately some normal cells also divide continually – those in hair follicles and the bone marrow. Older chemo agents affect these cells also, leading to the side effects.. The trick was to dose the chemo enough to kill the cancer cells without hitting too many normal cells.

      In the past decade there has been a big shift in the way the newer chemo agents work. A number of new agents such as rituximab target specific atigens on the the surface of cancer cells, selectively killing those cells expressing those antigens. Other agents inhibit vascular endothelial growth factor, inhibiting the growth of blood vessels into the tumor. Others target specific products, such as the tyrosine kinase inhibitors (some hematologic malignancies are caused by a chromosome translocation which creates a new gene which causes an enzyme called tyrosine kinase to be produced, which causes unrestricted cell division). Now attempts are being made to create activated T cells directed against cancer cells, though this is in trials. I could give different examples but I think the point has been made. Comments such as yours are repeated often in this site and just indicate the commenter’s lack of knowlege about cancer and about current chemo regimens.

    4. WilliamLawrenceUtridge says:

      Ronald, what happens if those nontoxic, safe alternatives don’t work? What happens if they aren’t actually safe and nontoxic? Laetrile, for instance, fails both. It’s ineffective, and it kills people via cyanide poisoning.

      Can you point to a safe, nontoxic chemotherapeutic agent that is actually effective? Aside from surgery for solid tumors I mean.

      In your quest to find information on “illness”, when you uncovered “effective” treatments, did you ask yourself these questions?

      1) Is it really an alternative? Many treatments proposed as “alternative”, such as weight loss, exercise and proper diet, all of which prevent a multitude of poor health outcomes, are recommended routinely by all doctors and all mainstream medical associations.

      2) What evidence supports it? Many quacks promote their treatments on the basis of questionable or fraudulent evidence. For instance, doctors will promote cures of individual patients, but follow-up finds that they actually died years before of the illness the quack claimed to have cured, like cancer for instance.

    5. Sawyer says:

      Please people, do yourself a favor and read up on, for instance, the history of chemo therapy and ask yourself a few questions.

      I would guess the regular contributors to SBM probably have somewhere in the neighborhood of 100,000 hours of education and training related to cancer or pharmacology. Do you realize how insulting and idiotic it is to pretend that they don’t know the first thing about chemotherapy?

      And if you don’t like listening to the so called “medical establishment” on cancer, what about those of us here that have never drawn a single paycheck coming from a drug company, or even from the NIH? What the hell is our motivation to promote a useless therapy or deny people “real” alternative medicine? We’re all suckers too I suppose for trying to understand the actual science instead of spending time on zany conspiracy websites.

  13. Bob says:

    David Gorski – There is hardly a blogger I have more respect for than you.

  14. Brad says:

    The Hagar situation struck a nerve with me, and I had a feeling you’d bring it up. I saw a link on Facebook a month ago about how Joe Satriani was helping to lobby for Hagar’s wife to get ANP’s. Satriani is my hero, he’s a guitar god. I was so disappointed in him.

  15. John Taylor says:

    Patients with some of these severe, aggressive forms should be allowed to make their own informed decisions. A comment Somewhere read that a few cases exist worldwide of survival or spontaneous remission of DIPG so the child who ANP cured must have been fluke. Fluke or not, these kids are going to die. If cancer doesn’t kill them, the secondary effects of the conventional treatments will. But hopefully not for at least five years so we can say they were cured! If I was in that boat, I would not want my options limited. No way ANP is more toxic than radiation or chemo. The cancer establishment uses patients as chattel. Let them make their own decisions. If Burzynski was so bad, word of mouth between patient families would be enough to put him out of business. If he was a really shrewd con man it might take awhile but it would happen. Bottom line is the families with loved ones he has helped testify what he does works. If my child had cancer, I would care more about personal testimony than “science”. Science can be engineered to show anything. Especially within a system as full of conflicts of interest as ours.

    1. weing says:

      “No way ANP is more toxic than radiation or chemo.” How would you know that without testing using science? The real question is does it do anything? Again you need to test it using science. If it doesn’t do anything and is not toxic like a drop of water, why not just use water? It’s a helluva lot cheaper.

      “Science can be engineered to show anything.”
      Oh, really? Maybe planes don’t really fly, the internet and your computer don’t really work. It’s just pretend like kids with tin cans and a string making a telephone.

    2. Windriven says:

      ” If Burzynski was so bad, word of mouth between patient families would be enough to put him out of business.”

      You have GOT to be kidding. You misunderstand the power of marketing. Gates became a zillionaire marketing operating systems that were pieces of crap until XP SP2. He used his franchise with IBM early on, then used preferential pricing of OSs to hardware manufacturers who agreed to use MS exclusively. WordPerfect was a far superior word processor to early versions of Word but MS bundled it with other second rate software to make it attractive to corporate buyers. The quality of the software eventually caught up and excelled (if you’ll pardon the pun) but largely because the competition had been starved of cash. I take nothing away from Gates. He achieved something monumental. But the achievement was a product of marketing not of technical innovation which, so far as I can tell is spelled C-O-P-Y in Redmond.

      Dying people and – often to a greater degree their families – tend to be frightened and desperate. This makes them an attractive market for sCAMmers. They want to believe. They need to believe. And when the scam fails it is inevitably because they didn’t find the scam soon enough. These people are to be pitied. The sCAMsters on the other hand should be drawn, quartered, minced, boiled in Crisco, buzzed in a food processor and used as fish food for piranhas.

      1. R.w.Foster says:

        That would be letting them off too lightly.

      2. Chris says:

        “He used his franchise with IBM early on, then used preferential pricing of OSs to hardware manufacturers who agreed to use MS exclusively.”

        He was also helped by having an open system which was great for computer home brewers, like dear spouse who built HAM radio equipment in high school (but was too shy to talk to strangers… the predecessor to Byte Magazine was “Computing 73″, created by a HAM radio magazine. “73″ has some meaning… I can’t find anything online, but there were a few copies in my basement until a woman from Paul Allen’s computer museum came and took them along with several boxes of Byte magazine away).

        He was also helped by Apple Computer pricing their systems too high. I don’t understand the dedication is users have. I once had iTunes on my system, but removed it because it had usability issues.

        By the way, I really liked Lotus’ AmiPro word processing program. I also really liked their calendar organizer. So much so I still have a version (from after IBM bought it out) on my computer.

    3. Sawyer says:

      If Burzynski was so bad, word of mouth between patient families would be enough to put him out of business. If he was a really shrewd con man it might take awhile but it would happen.

      One of the things that we have seen hundreds of times is that when you have a small group of people that are enthusiastic about an idea, the conversations that happen are absolutely NOT congruent with the scientific evidence for that idea. This is painfully obvious if you study the history of alternative medicine, although to be fair the same phenomena happens with real science too. People make a tremendous emotional investment (not to mention a financial one) when they go try Burzinski’s treatments. Once you buy into the narrative that he’s saving lives, it becomes incredibly difficult to question that narrative.

      This is how quacks have made a living for over a century. And as windriven pointed out, it’s also how clever advertisers get people to buy mediocre products. The difference is that mediocre products can eventually be molded into something better. The likelihood that ANPs will help people with cancer is headed in the opposite direction; it shrinks exponentially every day that Dr. Burzi refuses to publish trial results.

    4. WilliamLawrenceUtridge says:

      Patients with some of these severe, aggressive forms should be allowed to make their own informed decisions.

      Agreed, but emphasis must be placed on informed. As in, patients should be informed that there is no evidence that Burzynski’s treatments work, that he uses mixed high-dose chemotherapy with no rationalization to type and amount, that he charges very, very high case management fees, that his clinical trials are nothing of the sort, that his own lawyer has admitted the only reason they pretend to be running clinical trials is because it lets him keep making money, that patients have died and been hospitalized because of his practice of using massive infusions of sodium, that he has been found lying about his patients’ cancer progressions and regressions, and so forth. Yes, patients should definitely be informed – with real information, not the feel good huckster pablum that he gets his acolytes to spoonfeed desperate parents.

      Burzynski bucks and insults the “cancer establishment” for marketing reasons, not because he gives a shit about patients. If he gave a shit about patients, he would test his drugs properly that way he could help millions of them, instead of bare dozens that he personally treats at a cost of $10,000 per day in his home clinic that specifically allows him to avoid FDA penalties for sales across state lines.

      If Burzynski was so bad, word of mouth between patient families would be enough to put him out of business. If he was a really shrewd con man it might take awhile but it would happen.

      Are you kidding me? Do you know how long Bernie Madoff operated? As long as 40 years. Also, do you know what cognitive dissonance is? It’s what allows people to preserve their ideas of themselves. For instance – if a parent of a child watches their child die of cancer, after blowing $250,000 on treatments for piss extracts, they are far more likely to say “at least my baby lived longer thanks to Stan’s piss extracts” than they are to say “that douchebag fed my kid piss for four months, cost me a quarter-mill, and he should be stabbed in the face”.

      It’s very hard for people to admit they were wrong, particularly when it would mean admitting your child suffered a painful death from an agonizing treatment that emptied your bank account, all because you were too desperate to believe what real cancer doctors were telling you.

      If my child had cancer, I would care more about personal testimony than “science”. Science can be engineered to show anything. Especially within a system as full of conflicts of interest as ours.

      Three points:

      1) Yes, rather obviously you would accept personal testimony. Would you go looking for dissenting cases though? Would you go looking for the families of patients who died? Would you ask Stan “could you put me in touch with the mothers and fathers of kids who died because of hypernatremia?”

      2) Science can’t be engineered to show anything, but fraud can masquerade as science. Why you think Burzynski’s alternative of “deliberately abusing the clinical trials process to make money” is superior, I’m not sure.

      3) Why is it that Pfizer has a conflict of interest, but Burzynski doesn’t? How much money does Burzynski personally put in his pocket because of his lies about conducting clinical trials that never report out? You think Burzynski doesn’t make a handsome profit and revel in all the grateful parents that come to see him? And you think once the kid dies, he keeps meeting with those grateful parents or gives them a refund on the tens of thousands of dollars he charged them?

      1. Xogenisis says:

        Where’s the data to support all your hearsay and invented explanations? I am alerted immediately when someone purports to know what is in the mind of someone else.. The lie is obvious and the ethics of the liar are to be questioned.
        Why get all excited about a doctor who has been using a method of treatment for over 30 years. A doctor who has built a very large medical manufacturing facility to support his research. One who has been investigated by 5 federal grand juries. It is certainly easy enough to get the data to show the safety and efficacy of these treatments in the millions of documents seized from the doctor by the federal government. Yet you want us to believe you have a grip on the doctor’s state of mind? Your magical powers of mind reading are certainly better than any fraud of which you accuse the doctor.
        No data to backup insinuations make you an idle gossip or worse. Think profit motive.

        1. Windriven says:

          Well Xo, your old buddy Burzynski is big on promises but short on follow thru. He’s started a whole raft of ‘clinical trials’ but has yet to report them out. Further, as FDA has cited, he keeps sh!t records.

          You are familiar with the old computer acronym GIGO, yes?

        2. WilliamLawrenceUtridge says:

          Where’s the data to support all your hearsay and invented explanations?

          Wrong question. The right questions are, where is Burzynski’s evidence to support the effectiveness of piss extracts, where are his clinical trials now that it’s been over a decade, and where is his justification for charging customers thousands of dollars to be enrolled in clinical trials that never seem to report out?

          It is certainly easy enough to get the data to show the safety and efficacy of these treatments in the millions of documents seized from the doctor by the federal government.

          If it’s easy enough to do, why hasn’t Burzynski done so? And why has a review of said documents by outside experts found not just missing information, but outright errors (possibly deliberate lies, possibly simple incompetence, possibly even simple optimism leading to errors?

          Why does Burzynski have to keep bringing political pressure to bear to prevent federal agencies from doing their job? Why can’t he, with all the resources available to him (in the form of tens of thousands of dollars raked in from patient fees for most of his patients), simply do finish his clinical trials? Why does he need to appeal to senators rather than demonstrating his nigh-miraculous cures with data? Why did his lawyer publicly admit, of his own volition, in a book he wrote himself, that Burzynski’s “clinical trials” are “an artifice” to continue treating existing patients and to bring in new ones?

          No data to backup insinuations make you an idle gossip or worse. Think profit motive.

          Actually, profit motive does inform my insinuations and gossip – the idea that Burzynski has considerable profit motive to keep avoiding proper tests of his piss extracts so he can keep raking in his sweet, sweet case management fees.

          I rather heavily lean on this and prominently discuss it in the comment you reply to – Burzynski shows considerable evidence of abusing the clinical trials system to make money.

          Why are you so skeptical that Burznyski might be in it for the money?

  16. RE: The FDA doesn’t cave at all, it simply applies its “blue sky law” onto the unscrupulous physician’s untested and undocumanted non-RCTs of “antineoplastons”!?

    I would generally concur with the Goodnightirene’s assessment of yet another David Gorski’s magnum opus on SBM vs SB!?

    I reckoned that the FDA simply cannot violate the “patient-physician confidentiality law” itself, one that is professionally under the auspices of the IRB and the single patient IND rules; the FDA can only apply the general “blue sky law” (as in the stock markets) in this very infamous SB/ANPs case, as a last resort (but not cave nor compromise) as referenced above!?

    Best wishes, Mong 4/7/14usct2:16p; practical science-philosophy critic; author “Decoding Scientism” and “Consciousness & the Subconscious” (works in progress since July 2007), Gods, Genes, Conscience (iUniverse; 2006) and Gods, Genes, Conscience: Global Dialogues Now (blogging avidly since 2006).

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