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Attacks on the FDA on

I forgot if I ever mentioned that I have an article out in the current episode of Skeptical Inquirer about Stanislaw Burzynski. I call it a “primer for skeptics,” because that’s what it is. So, if you subscribe to SI (Skeptical Inquirer, not Sports Illustrated), read. If not, get thee to a newsstand before it’s gone. Thus endeth the plug and beginneth the Insolence.

When last I discussed Stanislaw Burzynski, I noted that, among other things, the state of Texas appears far more interested in putting abortion providers out of business than it does in protecting its citizens suffering from cancer from dangerous unproven chemotherapeutic agents, which is what Stanislaw Burzynski’s antineoplastons are. Meanwhile, every pro-quackery propaganda organ has been firing on all cylinders trying to drum up public support for pressuring Congress to pressure the FDA to let Burzynski administer his antineoplastons are and always have been. That’s not even including the fact that Burzynski uses lots of expensive targeted therapy along with chemotherapy as part of his incompetently administered “personalized gene-targeted cancer therapy,” or, as I like to call it, making it up as you go along. Coupled with that, Burzynski and his minions have been cynically using desperate cancer patients as pawns in their propaganda effort, even recruiting a rock star to help out. Indeed, some of us who have been following Burzynski, myself included, suspect that Burzynski and/or his supporters have been influential in promoting the recent rash of so-called “right to try” bills being considered in multiple states.

So it’s not surprising that one of Burzynski’s oldest supporters, a man who was featured in the very first movie made by Stanislaw Burzynski’s very own propagandist, Eric Merola, featured prominently, has published a resoundingly cranky defense of Stanislaw Burzynski. Unfortunately, he decided to do it what is arguably the number one “natural health” (translation: quackery) site on the Internet, I’m referring to a man named Ric Schiff, who wrote a post for entitled Medical System and Child Protective Services Run Amok: FDA Denies Hope for Dying Kids, and Other Abuses Waged Against Families Struggling to Help Their Ailing Children.

Schiff, as you might recall, is a San Francisco police officer whose daughter died in the 1990s after Burzynski treated her for a brain tumor. However, he does not blame Burzynski for failing to save her or for harming her. Rather, he blames the conventional therapy for his daughter’s death, claiming that she might have lived if only she hadn’t received chemoradiation before going to Burzynski and that Burzynski’s treatment had rendered her tumor free, although she died of radiation damage to the brain. Of note, I pointed out how irrelevant his assertion that, because he is a police officer, he is trained to detect fraud and therefore when he says there is no fraud in Burzynski he should be believed. As I pointed out at the time, Mr. Schiff might be a perfectly fine police officer, but that has pretty darned close to no bearing on his ability to determine whether or not Burzynski is on the up and up, and it has no bearing whatsoever on his ability to assess whether or not it was Burzynski could have saved his daughter. While I find it hard to be harsh on anyone who’s lost a child, I can’t help but note that Schiff has been spreading the Good News about Burzynski since then. More recently, he was found to have a profound conflict of interest in that he was appointed to the board of directors of the Burzynski Research Institute while a few months ago he apparently was one of the founders of a group, the ANP Coalition, that’s lobbying Congress either to change the law or to pressure the FDA to loosen up compassionate use exemptions. I’ve heard rumors that he’s since resigned from the board of directors, but I don’t have any evidence yet. If it’s true, it would go to show that there actually do exist conflicts of interest so severe that even the Burzynski Research Institute can’t tolerate them.

Be that as it may, Schiff is in fine fettle as he simultaneously attacks the FDA for not appreciating what a genius (he believes) Burzynski is and, in his mind, killing children:

It is often argued that the most heinous crimes that can be committed in our society are those committed against children. Defenseless children, who rely on the greater values and morality of society to provide for their safety, their growth and development.

But what happens when the government stands between parents and the possible cure for their child’s terminal illness? Take the following case for example. (The full story of Braiden Norton can be found on his Website,

I’ve discussed the Braiden Norton case before. As I pointed out at the time, by the parents’ own story, Braiden had a 50% chance of survival with conventional treatment. Also at the time, I mused that I might one day have to take a closer look at this particular case. Unfortunately, Mr. Schiff has made it mandatory that I do so now. I’m sorry he did, but he did.

According to the the entry on the Burzynski Patient Group website and website devoted to Braiden:

Braiden was diagnosed with a Juevenile Pylocytic Astrocytoma brain tumor that is located on the top of his brainstem at the age of one. He immediately underwent a 13 hour partial tumor resection surgery. Months later he had a subderal shunt installed to maintain proper pressure in his ventricles. Regardless of the surgery, the tumor grew back to its original size. We were pitched chemotherapy which I would ultimately turn down and instead bring Braiden to the Burzynski Clinic in Houston, TX where he was qualified to join an FDA phase 2 genetic targeted treatment called Antineoplastons. Braiden remained on this treatment for four years and responded beautifully to treatment while experiencing nearly zero side effects.

Braiden took a break from treatment in February of 2012 and has been completely free from any medication, showing signs of nothing short of vibrant health. However, a recent MRI in December 2013 showed signs of tumor growth. After having a extremely successful and professional experience with the Burzynski Clinic, it was a no-brainer that we continue Antineoplaston treatment. HOWEVER, to our surprise, the FDA is considering Braiden a ‘new patient’ therefore making the treatment completely inaccessible to him due to a convoluted ‘administrative hold’ they have placed on the Burzynski Clinic. How the FDA can declare my son a ‘new patient’ after being a proven success from Antineoplastons has our family and community flabbergasted.

The first thing that needs to be understood is that juvenile pylocytic astrocytoma is a rare pediatric brain tumor that, in most cases, is benign and slow-growing, and complete surgical resection can provide long term survival, or at least good quality of life for several years. Indeed, sometimes neurosurgeons will even delay surgery and choose watchful waiting, only intervening when the patient becomes more symptomatic. There is evidence in the literature that chemotherapy might be useful as an adjuvant in the case of an incomplete resection, which is what Braiden sounds like he had. Then, Braiden had an indolent course over five years, from 2008 to 2013, when his tumor apparently started growing again. On the website, we see two MRIs, represented as Braiden in 2008 and in 2012. Unfortunately they are difficult to interpret or compare because they are taken by very different techniques. It’s also difficult to determine whether antineoplastons truly had any effect, given how indolent these tumors often are. In any case, if, as the parents relate, Braiden’s tumor has started growing again, then there are still options, including an attempt at resecting it again, chemotherapy, and possibly radiation therapy, and, as has been pointed out elsewhere, even in the case of an incomplete resection, the ten year survival rate can be as high as 45%.

Once again, I have nothing but sympathy for parents with a child facing a life-threatening disease. However, there is no compelling evidence that Burzynski was responsible for Braiden’s previous good fortune or that his treatment would reverse the most recent recurrence. There is nothing in his story that justifies Schiff’s next rant. After proclaiming that the FDA “couldn’t care less about your welfare or last chance at hope” (which, by the way, is not true; otherwise there wouldn’t be a compassionate use protocol, also known as single patient IND), Schiff attacks:

The story of ANP brings to light some very interesting anomalies with respect to how cancer is dealt with in the US, both medically (called “standard of care”), and with respect to the FDA’s new drug approval process. ANP is a self-infused anticancer agent that can be dispensed on an out-patient basis. When it is successful, the patient can continue to live a fairly normal life as side effects tend to be relatively benign and short term. This makes the treatment much more desirable over conventional treatments, which would certainly lead to economic misfortune for the cancer industry if patients knew and understood the difference between these two types of treatments. Instead of fast-tracking ANP for the good of all, the FDA seems bent on curtailing its use whenever possible.


ANP offers a significant probability of survival to these patients and the FDA is well aware of that fact. Recently concluded ANP clinical trials showed ANP had greater efficacy for the treatment of brain tumors than all other clinical trials ever completed put together! But the FDA is demanding more. Under a compassionate request, it is established that there is no other treatment option. It is by definition a last ditch Hail Mary pass meant to save a life using an experimental (unapproved) treatment. There is virtually no legitimate argument for preventing these patients from receiving ANP because there is nothing that can be lost. They’re already dying.

What Mr. Schiff fails to mention are two things. First, it is Burzynski’s fault that the FDA is very resistant to permitting single patient INDs for his antineoplastons. He has utterly failed to publish evidence of efficacy and safety. Oh, sure, he’s registered six dozen phase II clinical trials, but he’s never published a completed trial, just a couple of preliminary reports and the occasional case study or small case series. If he’s had such miraculous results, he should be able to publish. If antineoplastons are as active against brain cancer as Burzynski’s patients believe, then he is profoundly irresponsible for not publishing. Of course, the real reason he doesn’t publish is because antineoplastons almost certainly don’t work, but if they did that would make Burzynski even more guilty of causing harm to patients than I believe him to be. Second, let’s not forget that a young boy named Josia Cotto died of complications of Burzynski’s treatment. That’s why the FDA put a partial clinical hold on antineoplastons for children, to follow it up with a hold on adults as well. That’s why Burzynski can’t treat new patients, only patients already on antineoplastons. That’s why the patients described by Schiff, most of whom I’ve discussed in detail before, can’t have antineoplastons. Given the utter lack of convincing evidence that antineoplastons have significant anticancer activity in humans and the existing evidence for their causing severe hypernatremia, these patients are almost certainly better off. As I’ve said before, there’s only one thing worse than dying of terminal cancer, and that’s to suffer complications with no hope of benefit or even to have your precious remaining days shortened unnecessarily.

After Schiff’s little tirade, Mercola jumps in and, amazingly, likens the FDA’s partial clinical hold on antineoplastons to child abuse, while complaining about cases like that of Sarah Hershberger, in which the family of a 12-year-old Amish girl with leukemia refused further chemotherapy for her, an action that will almost certainly result in her death, unless she was lucky enough to be in the minority who achieve long term remission after induction chemotherapy and a dose or two of consolidation chemotherapy.

I don’t know how much traction this latest round of Burzynski propaganda will get. After all, it’s all mostly on quack websites. Unlike past propaganda efforts, Burzynski has had minimal access to mainstream sources, as he did in the 1990s and even as recently as a year ago. Right now, he’s trying to rally the base, using mouthpieces like Ric Schiff.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

19 replies on “Attacks on the FDA on”

“This makes the treatment much more desirable over conventional treatments, which would certainly lead to economic misfortune for the cancer industry if patients knew and understood the difference between these two types of treatments.”

I wonder why Big Pharma hasn’t been wooing Burzynski to license them sell his antineoplastons at the same huge markup he gets, or, since his original patents have apparently expired, just bringing the product to market themselves at the same huge markup. I thought they’d do anything for money, even curing cancer.

ANP is a self-infused anticancer agent that can be dispensed on an out-patient basis.

Ah, so Burzynski has decided to save money on nursing staff by out-sourcing the duties of drug administration to the patients themselves?

Projection. The blame for not “fast tracking” ANP is all the fault of Burzynski. So instead of recognizing that information, they blame the easiest target.

That decision to have patients self administer, bimler, seems to have contributed to over a hundred overdoses.

I pointed out how irrelevant his assertion that, because he is a police officer, he is trained to detect fraud

As a police officer allegedly trained to detect fraud, Schiff should know that victims of a scammer are often in denial about the fact that they have been scammed. And as I think I pointed out at the time, we have every reason to suspect that Schiff was one of Burzynski’s marks. That he nonetheless thinks that his assertion that Burzynski is on the level is sufficient evidence to consider Burzynski to be honest is evidence that Schiff is not such a good police detective.

Poisoning people for profit. With no demonstrable value to anyone but himself.

“…because he is a police officer, he is trained to detect fraud.”

A typical argument from authority, and therefore wholly inadequate. After many years both interviewing and being interviewed I know just how empty “training” can be, and why it is so often ignored once the training is more than a few years in the past. Better questions are:

– Give me an instance or two where you investigated and discovered fraud, and brought it to a successful conviction.
– Give an instance where you failed to detect fraud, and what lessons you learned from the experience.
– Provide references of peer/supervisor/client who can corroborate what you’ve claimed.

Being trained in a field says little of ability or effectiveness. At least in this case Schiff seems to have failed to detect fraud, even when presented with evidence. Whether his BRI COI is a cause or effect of this failure I won’t hazard to guess.

Yes, the FDA are such meanies for having rules that everyone needs to play by. Burzynski doesn’t like the rules and so doesn’t play by them, but it’s FDA’s fault for not approving a product that hasn’t met the rules put in place to protect people from fraudsters like Burzynski.

Burzynski acknowledges that patients with Low-Grade Astrocytomas (LGA) indolent tumors and even says spontaneous regressions are possible.

It is wonderful that Braiden Norton has seemed to have good success, but such success cannot be attributed to Burzynski’s treatments.

Source: Burzynski, SR. Treatments for Astrocytic Tumors in Chiìdren: Current and Emerging Strategies. Pediatric Drugs 2006; 8: 167-178.
Impact factor of Pediatric Drugs for 2012 is a low 1.884

“When it is successful, the patient can continue to live a fairly normal life as side effects tend to be relatively benign and short term.”

If by ‘fairly normal life’ we mean drinking and excreting liters of water constantly to avoid hypnotremia…

So if I understand correctly, these people are petitioning the FDA and demanding a law change which will allow Burzynski to (a) take all their money, in return for (b) sending them home with a Hickman line and industrial quantities of cheap chemicals.
I’m beginning to wonder they don’t bypass the FDA, Congress AND Burzynski by simply doing it themselves. It’s not as if Burzynski’s prescription ever varied to fit the patient’s condition.

Warning: anecdote follows.

Advocates of ANPs claim a “fairly normal life”, although I agree with JGC that polyuria and polydipsia are hardly “fairly normal.”

My son coned because of an undiagnosed pylocytic astrocytoma.

He had “conventional” medical treatment, differing only in that it started with cardiorespiratory resuscitation in order to get him to surgery. His side effects were limited to the period of recovery from neurosurgery.

Following his “conventional” treatment, my son now lives a completely normal life (that’s if anyone can call the life of a university student normal).

It’s still a much better lifestyle than the “fairly normal life” following Burzynski’s “treatment” with ANPs.

a proven success from Antineoplastons

“Proven success” is an odd choice of words, in the context of a request for further treatment after the cancer’s predicted post-surgical recurrence. I would have thought that “A proven lack of success” would be a better description.

Still, Burzynski didn’t actually kill the patient, which is a success if the bar is set low enough.

What Mr. Schiff fails to mention are two things. First, it is Burzynski’s fault that the FDA is very resistant to permitting single patient INDs for his antineoplastons. He has utterly failed to publish evidence of efficacy and safety. Oh, sure, he’s registered six dozen phase II clinical trials, but he’s never published a completed trial, just a couple of preliminary reports and the occasional case study or small case series. If he’s had such miraculous results, he should be able to publish…

As I typically say, if anyone’s suppressing Burzynski, it’s Burzynski. An honest researcher in Burzynski’s position would have done all the tests and published the results decades ago. If the results were as amazingly positive as the hype would have us believe, antineoplastons would be mainstream drugs by now and cancer researchers would have moved onto other tough medical issues.

Researchers know they have to be able to move onto new questions because it’s their job to find answers to the current crop. Fortunately for their job security, answers tend to lead to new questions and there are always humans suffering from something, even if it’s old age and symptoms of living. And there’s always the demand for alternative answers with gentler side effects. Scientific research inherently attracts people who want to change the way we look at the world. Researchers don’t get fame, fortune, or warm fuzzies from maintaining the status quo. Researchers who fail to publish are more likely to wind up in obscurity and unable to get grants to fund their experiments. Science isn’t exactly the most lucrative career, either, so much of the time, researchers are people motivated to the point that they’re willing to give up luxuries to be on the bleeding edge of human knowledge.

Burzynski, however, has exploited loopholes (and, of course, unwitting victims deceived by propaganda) to make stagnation very profitable. Quack sympathizers want to make those loopholes even larger. It seems to me that most won’t be happy until human experimentation is completely unregulated and the free market replaces objective measures of safety and efficacy are replaced with measures of market penetration, profit margin, and subjective satisfaction achieved through brand loyalty-inspired rationalization and peer pressure.

Wow, that is one woo filled site. I had the unfortunate opportunity to link to the following article about the use of homeopathy and homoechords being used in organic dairy production.

“That was back in 1999 or 2000. Now when he uses homeopathics, he likes to use what he calls multi-potency homeochords. He still must “diagnose” (select) the correct remedy. He still needs to know what the remedies are called. But once he knows 3-4 indications, he knows what remedy is most appropriate. He then uses it in a multi-potency combination:mother tincture 1X, 2X,4X,12C, 30C and 200C – equal parts of ever increasing diluted and vigorously shaken original plant material.”

@Mike 15,

I am really puzzled by the use of multi-potency homeopathic remedies and haven’t seen a good explanation of what they think the benefit is. (My sister-in-law’s boy “friend” was bringing her some of them before she died of cancer.)

In scientific chemistry, the 1X concentration would swamp the higher potencies, assuming the dissolved chemical has any effect at all.

But, in homeopathic reasoning, the most potent tincture (200C) should overwhelm the lower potency parts.

So why mix them up?

Pardon the digression but this would appear to be a bit of good news:

Today it was reported on the Beeb that USA regulators have launched an investigation into Herbalife, makers of herbal supplements, on the grounds that Herbalife is a ‘pyramid scheme’ that works by recruiting new sellers rather than by actually selling product.

For more dirt on Herbalife including reports of liver damage, see also:

I’ve heard rumors that he’s since resigned from the board of directors, but I don’t have any evidence yet.

If so, they haven’t told the SEC. Departure of a director looks to be a Form 8-K triggering event (item 5.02); if so, it would have had to be reported within four business days (as was his appointment).

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