Elisha Cohen

Attacks on the FDA on Mercola.com

oracknows — Tue, 11 Mar 2014 02:02:25 +0000

Attacks on the FDA on Mercola.com

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, Mercola.com. I'm referring to a man named Ric Schiff, who wrote a post for Mercola.com 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, www.BraidenNorton.com.)

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.

And:

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.

oracknows Mon, 03/10/2014 - 22:02

Categories

Social Sciences

"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.

On the plus side, many of those ODs were eventually reported to the FDA.

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.

http://imgur.com/V3ldbD9

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
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf

"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.

http://healthypets.mercola.com/sites/healthypets/archive/2014/02/24/kar…

"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.

http://www.bbc.com/news/business-26553715

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

https://en.wikipedia.org/wiki/Herbalife

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).

Stanislaw Burzynski and the cynical use of cancer patients as shields and weapons against the FDA, this time with rock stars

oracknows — Wed, 12 Feb 2014 02:00:18 +0000

Stanislaw Burzynski and the cynical use of cancer patients as shields and weapons against the FDA, this time with rock stars

I don't know if it's a sign that I've arrived as being a bit more influential than just a blogger or just dumb luck when reporters start sending me things, but I'll take it. It's like blog fodder being served to me on the proverbial silver platter. Unfortunately, as a result of receiving a press release, FDA Denies Treatment to Two Terminally Ill Young Women, from two different sources, after yesterday's hilarious (if I do say so myself) bit of fun with a certain woman who fancies herself a "Thinker" when everything she writes shows that she is anything but, I find myself tackling a much more serious topic that elicits in me a complicated mix of outrage and sadness because it involves corrupting the most noble impulses of the human spirit by yoking them to the service of a man who deserves none of it at the expense of dying cancer patients. Did I say "dying cancer patients"? Given that I did, you know of whom I speak. Yes, it's Stanislaw Burzynski yet again. Truly, Count Stash is very much like what his heavy Polish accent reminds me of: A vampire who, no matter how many times you shoot or stab him (unless it's with a wooden stake through the heart), always rises again. I had hoped that Liz Szabo's excellent USA TODAY cover story about Burzynski in November might have been that stake, but unfortunately it appears not to have been.

As I've been documenting since before the Christmas holidays, patients with deadly brain tumors, both children and adult, have been putting themselves into the news in the service of trying to get the Food and Drug Administration (FDA) to lift its partial clinical hold on trials of Burzynski's "wonder drug," antineoplastons (ANPs). Those of you who've followed this story will recall that, as the result of a death of a child named Josia Cotto in June 2012 due to hypernatremia (too much sodium in the blood, a known complication of ANP therapy), the FDA put a partial clinical hold on Stanislaw Burzynski's clinical trials. Later, in January 2013, the FDA showed up at the Burzynski Clinic for an inspection and expanded the partial clinical hold to include adults. Now, to review briefly, a partial clinical hold means that Burzynski can keep treating the subjects already enrolled in his ANP clinical trials but cannot enroll any new subjects to those trials. The trials are, in essence, closed to accrual. That's why, beginning around Thanksgiving and continuing until now, there has been a concerted effort to try to reverse that situation. The Burzynski Clinic was very much built on the idea that he had a "natural" and "nontoxic" therapy (ANPs) that could cure incurable brain cancers. Without that concept, he was in trouble.

Burzynski's cynically jumping on the bandwagon of "personalized medicine," arrogant to the point of proclaiming himself a "pioneer" in the field of genomic medicine, by offering what he has referred to as "personalized gene-targeted cancer therapy" but what I refer to as "making it up as you go along." Unfortunately for Stash, this involves nothing more than using a commercially available gene test and then using its results to pick a cocktail of very expensive targeted chemotherapy agents from big pharma, which doesn't really sit too well with the "natural" crowd. Besides, the only difference between what Burzynski is doing and what, say, M. D. Anderson is doing is that Burzynski clearly doesn't know what he is doing and M. D. Anderson does. Moreover, poor Burzynski doesn't offer anything that any "brave maverick" oncologist couldn't offer. There's nothing unique in his "personalized, gene-targeted therapy." Given the choice of going to M.D. Anderson, Memorial Sloan-Kettering, or any number of cancer centers doing cutting edge genomic research in cancer or Burzynski's Houston office building, where are you going to go? It's no wonder Burzynski is floundering without ANPs. ANPs distinguished him from the pack, let him claim to have something "natural" that no one else had (never mind that he chemically synthesized ANPs in his manufacturing facility). Also unfortunately for Stash, selling an existing drug as a "prodrug" for ANPs apparently wasn't selling much better, either.

All of this is likely why a group known as the ANP Coalition was founded by a man, Ric Schiff, who is on the board of directors of the Burzynski Research Institute. It's why groups like the Alliance for Natural Health USA (ANH-USA) have tried to smear Liz Szabo and use patient stories to try to tug on the heartstrings of its members to the point where they will write their legislators to put pressure on the FDA to lift some of the restrictions on ANP use by allowing compassionate use exemptions for ANPs for patients with horrible tumors, people like a young Jewish boy in Houston with a medulloblastoma (an aggressive tumor of the brain) named Raphael Elisha Cohen, a twelve year old girl named McKenzie Lowe, who has a diffuse intrinsic brainstem glioma (DIPG), and Liza Cozad, the wife of the drummer in rock star Sammy Hagar's band, Liza Cozad, who also has a DIPG. It is Liza Cozad and McKenzie Lowe who were the subject of the press release from ANH-USA sent to me, which I will reproduce in full in case it goes down the memory hole:

McKenzie Lowe, age 12, and Liza Cozad Lauser, age 46, are both battling diffuse intrinsic pontine glioma (DIPG), a type of cancer that attacks the brain stem. There are currently no effective, FDA-approved treatments for this disease. The one option that has shown promise, antineoplastons therapy, is being denied them by the US Food and Drug Administration.

“Antineoplastons, which are peptides and amino acid derivates that activate tumor-suppressing genes, have shown tremendous potential in battling DIPG,” explained Gretchen DuBeau, executive and legal director of the Alliance for Natural Health USA (ANH-USA). “It is quite literally the only effective tool available to fight the disease, but in both these cases the FDA is preventing their use of the therapy. These young women have applied for Compassionate Use Exemptions, but neither has been granted permission to begin treatment,” DuBeau said.

The “Compassionate Use” or “Single Patient Protocol” exemption via the FDA’s expanded access rule allows for the case-by-case use of an experimental or unapproved drug outside of a clinical trial. To qualify, applicants must prove that they have a life-threatening condition; that no other treatment exists; and that the treatment offers no more risk than the disease. “Both candidates meet all these criteria,” DuBeau noted, “yet the exemptions are being withheld.”

The FDA’s denial has evoked a media uproar and a groundswell of support for the women. Senator Kelly Ayotte (R-NH) sent the agency a personal letter requesting that the FDA grant Ms. Lowe’s exemption. Two online petitions have garnered over 80,000 signatures asking the White House to intercede and pressure the agency to grant the exemptions.

“In addition,” DuBeau said, “ANH-USA forwarded over 26,000 letters to Congress from its members, asking that action be taken. And Sammy Hagar, former front man for Van Halen, is hosting a rock legends concert on February 12 to raise money and awareness for Ms. Lauser, who is the wife of his drummer, David Lauser.”

Lauser told reporters, “Why would you withhold something that would give her a chance?”

“Given the aggressive nature of this disease,” DuBeau explained, “the FDA’s failure to act swiftly to grant exemptions to these young women is seriously jeopardizing their ability to fight the cancer that has invaded their bodies. But since the FDA is not required to respond in any particular time frame,” DuBeau said, “there are no guarantees that an answer will come in time.”

The same misconceptions behind Burzynski's ANPs that were in the last set of press releases by the ANH-USA are there again, the most important of which is the flawed central premise, that ANPs are the only things that could give Lowe and Cozad a chance at survival. Sadly, because, despite the roughly six dozen phase II clinical trials Burzynski registered, only one of them has been completed, and that trial's final results remain unpublished. Indeed, there is no significant difference between the press release above and the press release issued January 6 about—you guessed it—Liza Cozad and McKenzie Lowe. The only difference is that press release was more detailed about Cozad's and Lowe's condition, and this one updates the efforts going into trying to pressure legislators to petition the FDA to do something that the FDA should never do: Compromise science and patient safety for political considerations.

I realize that these two people, one woman, one girl, are in a horrible situation. They have unrelenting, currently incurable disease. The problem is this. There is no evidence that Burzynski can do any more for them with his ANPs than conventional medicine can with science- and evidence-based palliative care, and there is plenty of evidence that ANPs are not benign drugs. Arguably, they are even more so than some commonly used varieties of chemotherapy. Burzynski likes to claim that no one has ever survived DIPG, but that claim is simply not true. Survival is rare, but certainly not unprecedented. So, absent the results of properly designed and conducted clinical trials, properly reported, there is simply no evidence to support Burzynski's claims other than the odd case report and small case series from the larger phase II trials, none of which are particularly convincing. Indeed, even his latest attempt at scientific relevance, poster presentations at the Society of Neuro-Oncology meeting last December showed some pretty abysmal results.

Perhaps the most infuriating aspect of this effort by ANH-USA and the ANP Coalition is one that I almost have to laugh at. Do you remember how the ANH-USA tried to claim that USA TODAY was running a "smear campaign" against Burzynski, based on Liz Szabo's expose? It was a ridiculously over-the-top lie, of course, but it comes across as even sillier given the article I saw in USA TODAY just last night, Sammy Hagar: Drug lobbyist (Really), which really should shatter any notion that there is some vast pharma-controlled conspiracy at USA TODAY to crush the upstart Burzynski because he's too close to the cure for cancer:

In the “Not Something You See Every Day” category, former Van Halen frontman Sammy Hagar is leading a group of other hard rock musicians in a campaign to get the Food and Drug Administration to approve an experimental treatment for a friend’s brain cancer.

In a letter sent at the end of January to FDA’s Center for Drug Evaluation and Research, Hagar and pals ask the agency to allow Liza Cozad-Lauser to have access to “an experimental treatment involving the use of antineoplastons.”

Cozad-Lauser is the wife of Hagar’s drummer, David Lauser, and the other signatories on the letter share the heavy metal connection: Van Halen drummer Michael Anthony; bassist Jack Blades of Night Ranger and guitarist Joe Satriani, who has played with a range of bands including Deep Purple.

I'm not a huge fan of Sammy Hagar's music, although I did like some of the stuff he did with Van Halen and some of his solo work, but I do have to say: He sounds like a straight up guy trying to do what he thinks is the right thing. Unfortunately, unbeknownst to Hagar, his altruistic impulse has been partially placed in the service of a cause that will harm cancer patients, his friend's wife included. Raising money for his friend's wife is good. Raising money and "awareness" among his fans to petition Congress in favor of Burzynski is not. The problem is that, while raising money for his friend's wife is a good thing, that good thing becomes very tainted if the purpose of the money raised from his concert tonight is to lobby Congress to pressure the FDA or even change the law. It's very easy to understand wanting to help a bandmate's wife, but unfortunately Hagar's desire to do good has been yoked to a cause that will, if he succeeds, harm cancer patients who are drawn into Burzynski's orbit. Worse, it's clear that Hagar and his friends have been fed the party line by someone associated with Burzynski. Just look at this statement issued by Hagar and friends:

“We are aware there are differences of opinion within the medical community regarding the efficacy and potential of antineoplastons in treating patients afflicted with this illness,” they write. “We are not asking the FDA to take a side in this debate. We are writing to simply urge that Liza be allowed to receive the treatment she seeks while research on the potential of antineoplastons for potential widespread use continues.”

No, there really aren't "differences of opinion within the medical community regarding the efficacy and potential of antineoplastons" against cancer, unless you define "difference of opinion" as Burzynski and his acolytes versus every other oncologist and oncology professional organization. Hagar has, sadly, fallen for the manufactroversy. ANPs have already been researched and judged almost universally by anyone who's looked at them besides Burzynski and a Japanese researcher not to have significant potential against cancer. Worse, if the FDA were to allow a compassionate use exemption for Liza Cozad Lauser and McKenzie Lowe, then there would be no valid reason for it to refuse a compassionate use exemption for anyone that Burzynski could produce with a terminal cancer. He'd be back in business again, no pesky need to publish those clinical trials he's already claimed to have done, no need to enroll more patients on clinical trials. That alone would be reason enough, but, as much as Burzynski drones will try to paint me as cold and heartless, I'm thinking of Liza Cozad and McKenzie Lowe. As hard as it is for their families to accept, they would be better off not going anywhere near the Burzynski Clinic. Burzynski will treat them, and they will spend a lot of time with portable infusion pumps, ports, IV medications, and the like. In the end, they will likely suffer a significant decrease in the quality of their remaining life, with no evidence that choosing ANPs will prolong it significantly.

What's clear to me is that Burzynski is trying to do what worked for him the last time his back was against the wall, in the 1990s: (1) rally the base by appearing on quackery-friendly radio shows (now usually podcasts) claiming oppression and firing Godwins at his enemies (oh, look, he just did it a couple of days ago); (2) tug at the heart strings with cancer patient anecdotes like this entirely credulous one recently published, Dartmouth dad appeals to FDA to renew son's tumor treatment (even Hannah Bradley and Pete Cohen recorded a video in support of the effort); (3) recruit celebrities like Sammy Hagar and Joe Satriani; and (4) try to pressure individual Congressional representatives. It's even worked with Sen. Kelly Ayotte (R-NH), and, although I haven't been able to locate the letter to the FDA from her, I'm told that it's worked with Sen. Jeanne Shaheen (D-NH).

There's little doubt at the moment that Burzynski is in trouble. I've heard rumors that, when put together with other sources to which I have access, paint a picture of a clinic in big trouble due to a large drop in patient volume. The Texas Medical Board is on his case again. The FDA, for now at least, shows no signs of loosening up its partial clinical hold on ANP clinical trials. As bad as his situation is, though, Burzynski could still potentially turn it around if he succeeds in his strategy, as I've outlined above. That's why now is not the time to be complacent. Now is the time to turn up the heat. Write your Congressmen and Senators. Don't let credulous articles like this one or the USA TODAY article pass without letters to the editor. Be ready for all the entertainment blogs and magazines that will likely report on Sammy Hagar's concert as an uplifting human interest story and ignore or downplay the issues with ANPs. Now is not the time to let the pressure off.

oracknows Tue, 02/11/2014 - 21:00

Categories

Social Sciences

These tactics disgust me. They make a mockery of cancer patients like myself who participate in real clinical trials.
With only a small chance of benefit, we risk sacrificing much of the remaining quality time in our lives so that research can be advanced, not so that celebrities can bump their friends to the front of the line.

Just to be clear, this kind of media campaign wouldn't be any more palatable if these patients were seeking uncontrolled access to trials that really did have some potential for benefit. The breast cancer bone marrow transplant story from the 90's illustrates how end-plays around the process delay research. If every cancer patient who is willing to risk taking experimental drugs gets them through politics not protocols, who is left to actually be in a controlled trial?

We are not asking the FDA to take a side in this debate

Instead, they are asking the FDA not to take a side in the scam-or-experiment debate, which is unfortunate, that being the FDA's job.

I'm not surprised that Ayotte has fallen for this scam. She has been reliable in the sense that whatever her opinion on a given issue, you can safely assume that the opposite is closer to the truth.

Shaheen is up for re-election this year. I know the Republicans have dreams of taking that seat, although I'm not aware of a plausible candidate to take her on (and I'm one of her constituents).

Ignorance is a bipartisan issue.
http://dish.andrewsullivan.com/2014/01/29/vaccination-is-neither-red-no…

Merck (Glaxo, Sanolfi, you pick) has been experimenting on cancer patients for 35 years. They refuse to publish their results, but they claim that their special, non-toxic medicine works. The FDA has finally stopped this activity after a child died from receiving the therapy and numerous lapses were found in Merck's medical recordkeeping (including falsification of data), financial management, and care for the welfare of experimental subjects.

Do you think anyone would be lobbying the FDA to allow Merck to continue after they'd done that? Doubtful. Burzynski is a multimillionaire living in a $6M mansion in Houston.

$6M buys a lot of mansion.

MedTek - Unfortunately, that's not a very effective argument, given that a couple of big pharma companies have recently received ten-figure fines precisely for promoting drugs for unproven uses while hiding evidence of life-threatening side effects, and their business is still in full swing while their CEOs and major investors lounge freely about their own multi-million-dollar mansions.

Jane, the pharmaceutical companies were punished (likely not harshly enough) and can now no longer promote those drugs for the unproven uses. Shouldn't Burzynski be held to the same standards? Fined a large amount and stopped from promoting his quack cure for unproven uses?

The FDA has fined drug manufacturers for promoting certain drugs for "off label" use.

http://en.wikipedia.org/wiki/List_of_off-label_promotion_pharmaceutical…

Burzynski has never completed clinical trials for his ANPs or gotten approval from the FDA, during the 30 plus years he has been "treating" cancer patients. And, as Orac stated above, he now prescribes (and sells, through his pharmacy), cancer treatment drugs which have no proven therapeutic value for his patients' particular types of cancers. (The kitchen sink approach)

The thing is, if a good friend said to you, "My wife has found a wonderful new treatment for her cancer, will you help raise money to pay for it?" would you say "Great, sign me up!" or would you say "What exactly is this treatment? Is it proven? I want to research it before I join in the fundraising." Most people would go straight to the first and consider the second tactless or worse. I myself think that caution would be the part of a good friend, but I'm in a minority there.

I would ask for time to investigate before deciding, and then I'd say something like, "I've checked out this doctor of your wife's, and I don't like what I've learned, I don't think he can help her. In good conscience I can't promote him or raise money for him. I think you ought to hear what I've found out, but it's okay if you don't want to, and whatever you and your wife decide to do, I won't criticize you. I'll still be your friend, and be with you through everything, I just won't help you raise money."

Lifestyle, experimental injected substance and medical advice from rock musicians.

What could possibly be wrong?

@Vasha #10- I too would be in the same minority there. I'm afraid occasions like that are really not a good time to be your usual tactful self & not ask questions as there's simply too much at stake.

Of course, living in Australia (where it is generally known that proven cancer treatments, for now, anyway) are covered by the State makes it a lot easier to identify situations in which a friend may be the target of a scam. I have found myself in the situation where I was concerned that a friend was being hoodwinked by "alternative" medicine. Although I wasn't directly asked for money my forthrightness regarding the issue did not bode well for the friendship, which I suppose can only be expected.

Surely Burzynski & his long used method of by-passing federal law regarding clinical trials is no secret by now? I understand the desperation of families of the desperately ill, though I'm frequently shocked by the willingness of some people to believe in a "conspiracy to suppress cancer cures". One only has to read a few of the replies to Hannah Bradley's latest vlog to see how virulent an idea it is.

It is despicable when anyone uses terminally ill children to further their own cause. Imagine the (justified) outcry if larger drug companies tried it as a marketing ploy.

their business is still in full swing while their CEOs and major investors lounge freely about their own multi-million-dollar mansions

Dispatch from the Why In G-d's Name Am I Bothering to Fact-Check This Dep't:

Merck's CEO is Bucks County, PA, parcel 47-009-031-019, a four-bedroom house on a 1.56 acre lot, valued at $1.12 million. Not that 5210 square feet is anything to sneeze at, mind you.

Count Scamula, whom one might idly observe has substantially fewer responsibilities, is Harris County, TX, account 1298230010001. Regrettably, their search engine is down. It value at just over $5 million, and from memory, the house alone has a footprint of a third of an acre, about 6 times that of Merck's CEO's, with something like 10 bedrooms. The lot, again from memory, is around 20 acres.

I'd say that the complaint that the comparison is "not a very effective argument" is rather sorely dependent upon the fact that Scamley basically has no job other than "promoting drugs for unproven uses while hiding evidence of life-threatening side effects."

^ ("it is valued at"; time to plug the Firefox memory leak with signal 9 again)

It's good that this "pioneer in gene targeted therapy" was able to use a commercial service for genotyping tumor (for gene targeted therapy) that was already providing services to a couple hundred medical centers.

I suppose he's like the pioneers who settled the American West in the 1960's by buying a home there. Bold pioneers who crossed the Continental Divide in driving snow, using nothing but a Greyhound bus and an Interstate.

jane,

a couple of big pharma companies have recently received ten-figure fines precisely for promoting drugs for unproven uses while hiding evidence of life-threatening side effects

Which drugs are you referring to? If it's Avandia, you should also add that those alleged "life-threatening side effects" turned out to be unfounded.

I have developed some sympathy for drug companies recently. Many of the high-profile cases that appear to prove that drug companies are interested only in money, and not in patients welfare don't hold up to closer scrutiny. I think this is part of a current trend towards demonizing large corporations, which I don't think is very helpful.

For example GSK spent billions developing Avandia, a hypoglycemic drug prescribed for diabetes. The drug is very effective, and works by increasing insulin sensitivity, which is reduced in type 2 diabetics. However, between 2007 and 2010 some studies found an association between use of the drug and increased risk of cardiovascular disease. GSK were censured and fined for not making this information available at the time it launched the drug. The drug was withdrawn and law suits were brought, all of which must have cost GSK huge amounts of money.

However, more recent studies suggest that all drugs of this class have some adverse CV effects, though this is hard to tease out from the adverse CV effects of diabetes itself. Avandia now appears to be one of the safer hypoglycemic drugs, and the FDA have removed the restrictions on its marketing. This means that many patients were put on more dangerous and less well-tested drugs while Avandia was under suspicion. It seems to me that more patients were put at risk and were very probably hurt by the knee-jerk reactions of regulators than by the behavior of GSK.

It does seem odd to me that GSK were censured and fined for developing and marketing a very effective drug that is no recognized to be very safe, while Burzynski has been apparently free to peddle his dangerous and unproven treatments for decades relatively unmolested.

Bold pioneers who crossed the Continental Divide in driving snow, using nothing but a Greyhound bus and an Interstate.

Forced by hunger to resort to eating a Doner on the way, no doubt...

@Kreb

In these parts we spell it donair. Which leads me to wonder if the problems of the Donner Party were all due to bad spelling.

The whole find a cure for cancer is a total scam.

Lots of fat cats making money and people are dying, like my mom did and grandmother before that.

It's a big money maker. Why find a cure.

The blood suckers (drug companies) are making a killing and the FDA is in bed with them. Yeah, they fine. Got to look like they are doing something. But they are the government.

And do you people here REALLY trust your government?

Are you kidding me. This government would bankrupt a lemonade stand.

@Mike - so, what about the groups of Cancer that can be cured? How about the longer survival rates?

Anything other than rant?

Okay. They are all saints.

What was I thinking?

And what's up with drugs causing serious problems with some patients. Drugs approved by the almighty FDA?

Any repercussions for them?

Not really, they are the government! They are not responsible for anything.

Mike, please try to make sense.

I think you will find that when drugs go bad it also goes bad for the drug companies. Vioxx ring any bells?

You are being incoherent because most of the things you claim don't happen have happened.

@mike

So, got any actual proof for your rant?

Mike, your shot pattern is all over the place. Try adjusting your choke bore.

Mike,

The blood suckers (drug companies) are making a killing and the FDA is in bed with them. Yeah, they fine. Got to look like they are doing something. But they are the government.

If only the drug companies, FDA and US Government were made up of human beings like you and me, with parents and wives and children who got cancer, and who got cancer themselves. Then maybe they would care about finding cures for diseases instead of wanting everyone to be sick forever. But no, those inhuman bastards, "they fine" while the rest of us suffer the increasing longevity and healthy old age they are inflicting on us.

If only drug companies operated like normal companies, with shareholders who want them to make a profit by producing safe and effective drugs, instead deliberately making poisons to kill their customers for no apparent reason.

[/sarcasm]

One more thing:

Are you kidding me. This government would bankrupt a lemonade stand.

The most successful economy on the planet is run by idiots who would "bankrupt a lemonade stand"? What chance do the rest of us have?

@Kreb - good point....and I will point out that it was government intervention and regulations that prevented the fairly regular series of "Depressions" that the US has experienced since its founding, right up until the Great Depression.....not exactly a great track record for "Big Business."

The 2008 Crash can be directly linked to the Federal Reserve keeping any and all regulation away from so-called Derivative Swaps & encouraging the fanciful accounting that made the mortgage collapse happen.

Not really, they are the government! They are not responsible for anything.

Perhaps you'd like to get your shıt together and actually say something about Scamislaw. Do you "REALLY trust" this asshοle?

That joke about eating Doner is either the internets award winner or in seriously bad taste (pun stolen from Isaac Asimov). I can remember heading up I-80 in the eastern Sierras and being turned back by the highway patrol because of an early season snowfall. I doubled back and actually stayed in the town of Truckee, which figures centrally in the Donner party account. Getting into weather at an altitude above 8000 feet can be serious in that part of the world. A little further south of that route, they close the Tioga Pass for most of the winter due to snow, but it's at 10,000 feet, and about 80 miles east of there, they close Titus Canyon (in Death Valley) during the summer because of the heat. The world record high temperature is at Badwater, on the valley floor, but Titus Canyon, although mostly unrecorded, is said to be worse.

people are dying, like my mom did and grandmother before that.
Yeah, my mother died too. And my grandmother before that. My great-grandparents and great-great-grandparents are also all dead. I'm beginning to see a pattern.

Bob G.,

That joke about eating Doner is either the internets award winner or in seriously bad taste (pun stolen from Isaac Asimov).

Is it too soon? I could continue with jokes about it not being my idea of a party...

I recently stumbled upon an episode of a ghost-hunting TV show, in which Jack Osborne went to the site where the Donner party got stuck, in the winter, and tried to contact some spirits trapped there by spiritual indigestion or something. Their thermal camera went haywire, probably due to the cold, one of them got scratched by a twig, and something resembling teeth chattering was picked up on their audio recorder, so definitely ghosts. I'm not sure why, but I have some affection for such nonsense, such as the over-optimistically named 'FInding Bigfoot', now into its 5th season.

#19 I have to agree. Thinking we'll find "a cure" for cancer, when there are loads of different types of cancers, with different causes and different mechanisms, in different parts of the body, is pretty scamulous.

Of course, that's pretty much exactly what Burzynski does.

I thought the Donner party was the one Rudolph didn't get invited to.

I went to Change.org to sign a friend's petition, and the sponsored petition I was offered next was for the Burzinski clinic. When I searched for the direct link to the petition, it turns out there are a TON of petitions to "legalize antineoplastons" etc.

http://www.change.org/search?utf8=%E2%9C%93&q=antineoplaston

You ought To be ashamed of yourself. Don't you dare use my name for your so-called article. I promise you you have no idea what you are talking about. The Science is there and the FDA as well as the national Institute acknowledged it years ago, so do not speak about that which you do not know. I'm sorry you're so scared of something that works. You might want to do your research next time (my guess is you work for a drug company has so many of the people with this attitude do) it doesn't matter. They have been approved for phase III clinical trials - . this means they passed phase 1 (safety) as well as phase II (efficacy); frankly for those of us who can be cured this by this WHEN STANDARD MEDICINE ADMITS THEY HAVE NO CURE just do not speak at all will do yourself well.

I'm very, very sorry, Liza. You are surrounded by awesome friends of immense generosity and compassion. However, if the FDA allows you on the treatment, there will be no basis to protect other patients from this: https://theotherburzynskipatientgroup.wordpress.com/damning-fda-finding… The good news, however is that there are other trials into brainstem tumors open. You can review them here: http://clinicaltrials.gov/ct2/results?term=brainstem+glioma&recr=Open

@Liza - legitimate clinical trials don't charge their patients hundreds of thousands of dollars for unproven treatments...think about that....

"I promise you you have no idea what you are talking about"

Even though the author is an oncologist?

Also, if you dislike your name being used in an article then you should be going after those who released those press releases. If you make it public, then you do not have any cause to object to those who comment on your choices. Especially when that person is a qualified cancer doctor.

this means they passed phase 1 (safety) as well as phase II (efficacy)

Sadly, untrue. Phase-II trials were open for many many years but the results -- if Burzynski bothered to record them -- simply disappeared down the memory hole. Burzinski's own lawyer boasts about the fact that the trials were a joke, a way of getting around legal barriers and charging people for snake-oil.

They have been approved for phase III clinical trials

And now they're unapproved again. Perhaps they aren't safe or effective after all.

Sounds like Liza has been lied to by the clinic....

Liza,

I'm sorry if my post has upset you. I realize that you probably won't believe this, but I wrote it for you and others in your horrible, horrible situation. I know, at least as much as it is possible to know without being in your shoes, how terrible your situation is. I can also sense how desperate you and your husband are, and i appreciate how Sammy Hagar thinks he's doing the right thing for you. I really hate that I'm one of the ones who has to say this, but Stanislaw Burzynski can't save you. There is no convincing evidence that he has been able to save anyone, his claims otherwise notwithstanding. I realize that you likely won't believe me, but I feel obligated to say it anyway. I am also very aware that, no matter how sensitive I try to be, I will be easily painted as the bad guy for saying this.

The Science is there

Where? Burzynski certainly isn't coughing it up.

and the FDA as well as the national Institute acknowledged it years ago

No, they haven't.

I’m sorry you’re so scared of something that works.

What "we," if I can risk speaking generally, are scared of is Burzynski continuing to be allowed to swindle desperate people and those who care deeply about them. Your decision is your decision, and it's a cruel one to have had imposed upon you and yours. As Bob Blaskiewicz notes above, though, there are legitimate clinical trials available. They don't make promises. Burzynski does, and afterward, his groupies make excuses.

They have been approved for phase III clinical trials – .

One such trial was approved. It closed without enrolling a single patient.

this means they passed phase 1 (safety) as well as phase II (efficacy)

Unfortunately, it doesn't. As Burzynski's own lawyer, Richard Jaffe, has freely admitted, the very existence of the phase 2 trials is "an artifice."

I'm sorry that I (and others) have to argue with you here, but repeating the Burzynski propaganda that you have been led to believe demands a response, as difficult as it is provide.

Liza,

I’m sorry you’re so scared of something that works. You might want to do your research next time (my guess is you work for a drug company has so many of the people with this attitude do)

So, you brought out the hoary old pharma shill gambit. Consider this, if you will:

Pharmaceutical companies make a *lot* of different products. If they went out of the cancer chemotherapy business tomorrow, they would still have plenty of other products to offer, and the great majority of their employees would still have jobs. But Burzynski's sole business is treating cancer patients. If he stopped treating cancer patients tomorrow, he and all his employees would be out of work.

Who, then, has the greater incentive to ignore contrary evidence? To shade the truth in their own favor? To lie? Who is most likely to act the shill in this case?

Speaking of the pharma shill gambit, it's not really a good fit for Burzynski's position. The usual way it goes is, "Big Pharma is suppressing a cheap natural cure for cancer because it's cheap -- so they can't make a lot off it -- and it's natural -- so they can't patent it and so won't research it. Buy my book and this overpriced supplement, and tell Big Pharma to take a long walk off a short pier!"

But that doesn't work for Burzynski. His treatment isn't cheap, and natural or not, it can be patented because he did patent it. Big Pharma has every incentive to license it from him and he has every incentive to license it to them. If he cares about saving lives, he could save a lot more lives by licensing a working treatment so that it can be provided to millions than he can in his one clinic. If all he cares about is money, he'd make a lot more from licensing fees for a working treatment that could be used on millions than he does off his one clinic. The only incentive for him not to license it to Big Pharma, and Big Pharma not to license it from him, it is that it isn't a working treatment.

And speaking of patents, he's sat on his antineoplastons patents for so ling that the original patents have expired. Big Pharma could have gotten on the gravy train years ago with a working treatment based on antineoplastons without paying him or anyone else any royalties ... but they haven't. Because it isn't a working treatment.

Let's consider also the insurance companies. They won't pay for Burzynski's treatment. If it worked and was even comparable in price to the other treatments that they do pay for as doctors desperately try to find an effective treatment, what incentive would insurance companies have *not* to pay for it? They aren't wed to Big Pharma -- indeed they will often push people to generics instead of drugs under patent, thereby depriving Big Pharma of income. They don't pay for Burzynski's antineoplastons because they don't believe he has a working treatment. And they with their experts are in a lot better position to review the evidence than is a cancer patient who is desperate to find something, anything, that will work.

Speaking some more of the pharma shill gambit, since the standard form doesn't work for Burzynski, he and his minions have come up with another form, the "pride" form. That is, Big Pharma won't use his treatment because it was invented outside the mainstream and that hurts the pride of mainstream researchers.

The problem with this is that billions of dollars in profit will salve a lot of hurt pride. And Big Pharma companies exist to make money for their shareholders. If a Big Pharma company's board of directors allowed the company to disregard billions in potential profits for emotional reasons, that board of directors would be in big trouble from the shareholders. Does anyone really believe that in over thirty years *nobody* has thought to bring a shareholder's suit against a board of directors for disregarding potentially billions of dollars in profits for a working treatment for no good reason?

Someone would have brought such a suit. Unless, of course, those who have the time, expertise, and emotional distance which a desperate cancer patient lacks, have examined the evidence and determined that Burzynski does not have a working treatment.

Speaklng of legal actions, if the clinic is fraudulent, why hasn't it been shut down? Why isn't he (Burzynski) in jail, let alone have a medical license or even sanctions? Seriously curious as to what the prevailing 'wisdom' is here.

@kc

Orac's actually talked about that quite a bit. The following link is a pretty good analysis of why he's managed to keep on chugging along for so long (apologies that it's not a hyperlink: I'm either incompetent at HTML, or my browser just likes to crash when I try it):

http://scienceblogs.com/insolence/2013/11/15/stanislaw-burzynski-in-usa…

Long story short, the Texas Medical Board (and most medical boards in general) is very hesitant to act unless it's an extremely clear-cut case of criminal activity, such as murder, sexual assault, etc; whereas the FDA is hamstrung by influential Burzynski supporters and the fact that he's very, very good at exploiting loopholes.

Well, that's unexpected. I just copied and pasted the web address and it linked it for me. I don't remember it doing that before.

I guess I probably am just incompetent :P

WordPress even adds the rel="nofollow" tag to the links it creates that way. :-)

IF: Long story short, the Texas Medical Board (and most medical boards in general) is very hesitant to act unless it’s an extremely clear-cut case of criminal activity, such as murder, sexual assault..

Sexual assault isn't a crime in Texas. I doubt the TMB even thinks murder is a crime.

indigo_fire, did you post the right link? that doesn't address my questions. I would expect at least sanctions or malpractice lawsuits. I don't see even those, though I didn't do an extensive search.

I fear kc is being deliberately obtuse.

I fear kc is being deliberately obtuse.

Yup. The scare quotes ('wisdom') and Just Asking Questions attitude are a dead giveaway.

I fear Johanna doesn't understand that ad hominem attacks are not refutation.

I fear Johanna doesn’t understand that ad hominem attacks are not refutation.

1. Johanna's comment is nowhere close to an ad hominem (by the way, what does that mean in your own words?)

2. A refutation of what? You've made no actual arguments so far. You observed that there haven't been sanctions or malpractice suits, and concluded...nothing.

Adam, I'm dead serious about shutting down the clinic if it's fraudulent. However, I'm not swayed by bad argumentation, or unsubstantiated opinion. Some people have made some references to legitimate, documented issues and they have credibility. Those of you who are incapable of such are inconsequential and a waste of time, and probably air.

Adam, my HS taught latin and I took debate, not to mention formal logic. If you don't understand it, google it.
Frankly now you're being deliberately obtuse, or sadly maybe it's not deliberate. look at the context of the discussion. and try again.

Politicalguineapig, please do not make statements like this: "Sexual assault isn’t a crime in Texas. I doubt the TMB even thinks murder is a crime." You know that they are not true and only cause unfriendly responses to you.

that doesn’t address my questions. I would expect at least sanctions or malpractice lawsuits. I don’t see even those, though I didn’t do an extensive search.

Then you didn't search very hard.

However, Texas is a very doctor-friendly and malpractice suit-averse state. There's a strict cap on pain and suffering damages; as a result few lawyers will take malpractice cases on a contingency basis. In other words, it's about as perfect a state for Burzynski as there is.

http://scienceblogs.com/insolence/2013/09/20/patients-endangered-by-fai…

do you have links to sanction, malpractice, lawsuit information?

LW: How are they not true? If something isn't prosecuted, that's the same as it being legal.

Oh come on PGP, that's demonstrably false.

http://www.tdcj.state.tx.us/documents/Statistical_Report_FY2012.pdf

Page 26.

If all violations of a law must be prosecuted 100% of the time in order for those violations to be considered illegal acts then... the world is a lawless place.

@kc

Yes that's the right link, and it certainly does answer the part of your second sentence where you asked why he still has his medical license (which is under the purview of the Texas Medical Board) and whether he's sanctioned or in jail (which FDA actions against him would likely lead to).

If you think that that doesn't answer any of your questions, then you either need to formulate them better, or you're being obtuse.

i hate to feed trolls but here you are (again, since orac and others already gave you this info ) http://reg.tmb.state.tx.us/OnLineVerif/Phys_ReportVerif_new.asp

@brook, that produces an OLEDB error. And if all you can do is display bad links and bad manners, please go back to reading your graphic novels.

Guess I'm just obtuse Indigo, which is damn funny given where my IQ stands on a bell curve. Now if all you can do if post links to someone else's thoughts, I'm off to find someone who has a brain.

kc, have you read the FDA's inspection report?

http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegu…

"You failed to protect the rights, safety, and welfare of subjects under your care. Forty-eight (48) subjects experienced 102 investigational overdoses between January I, 2005 and February 22, 2013."

kc: "I fear Johanna doesn’t understand that ad hominem attacks are not refutation."
kc: "Now if all you can do if post links to someone else’s thoughts, I’m off to find someone who has a brain."

Good luck with your search. And you can mail me a replacement irony meter c/o Orac.

Yes Adam, I've read some of those. I'm not disputing there are some serious issues there. I'm looking for tangible evidence of sanction, malpractice or lawsuit , hence my request enumerating them. Are there complaints? If there are complaints, why is the medical assoc. not investigating? Where are the lawsuits? For those too dull witted to recognize it otherwise, I am seriously asking why isn't the medical community policing itself? There's the first problem.
Tangentially, there are some serious admissions of corruption at the FDA. Again, for the dull-witted, I"m not saying that the substantiated corruption at the FDA is in anyway related to the BC issue, but it speaks to the credibility of the organization. Most of what I see here is the same lack of rigor that the clinic is (apparently justifiably) accused of. I see a lot of people talking, but few with anything to say.

@ Dangerousbacon, nice quip - who did you copy that from? Got any original thoughts?

Kc, my apologies. just go to the TX medical board (http://www.tmb.state.tx.us/) and search for Burzyinski. The pater's middle name is Rajmund.

What you got against graphic novels?

thanks Brook, I'll check it out.
re: graphic novels - nothing, they make excellent compost. :)

Kc, you want to know why "they" (I'm on a phone and must use shorthand) aren't prosecuting B.

Shouldn't you ask "them", perhaps? After all, I can't speak for the Texas Medical Board...

@johanna, I don't know who you are are what your background is. However, I'm throwing your comment back at you. if you find the time for meaningless posts, perhaps your time would be better spent lobbying those organizations who could positively affect the issues your profess to care about.

kc, what is your solution?

kc, if you don't think that FDA report is evidence of malpractice, I'm not sure what you think would be.

@chris, @adam, see my response to Johanna.

@AdamG, thanks for the link for the Texas Department of Criminal Justice. On page 30, they list numbers received with "offenses of record" including sexual assault, sexual assault on a child, and indecency with a child. They also include assault, and a sexual assault might be charged as assault instead or in addition, depending on now strong the prosecutor thought the evidence for the case was.

Politicalguineapig, you appear to be thinking of some case which you think should have been charged but was not. That can happen for a number of reasons, including a corrupt prosecutor who is paid off or simply indifferent to crimes against women.

But even if that is what happened in the case you are thinking of, that does not mean that every district attorney in the State is paid off or indifferent. And, if you learned of the case you're thinking of on the Internet, that may not be what happened at all -- descriptions of crimes on the Internet frequently bear only a passing resemblance to the actual evidence.

@kc, there's Lola Quinlan's lawsuit:

http://scienceblogs.com/insolence/2012/01/20/more-trouble-for-dr-stanis…

So, kc, have you written some letters?

Yes Adam, I’ve read some of those. I’m not disputing there are some serious issues there. I’m looking for tangible evidence of sanction, malpractice or lawsuit , hence my request enumerating them. Are there complaints?

Yes.

If there are complaints, why is the medical assoc. not investigating?[/blockquote]

Assuming you mean the American Medical Association: Because that's not what it does.

Where are the lawsuits?

Most personal injury lawsuits are settled out of court confidentially and never become part of the public record.

However, there is -- as noted -- Lola Quinlan's suit.

Additionally, there are some patient lawsuits among the cases you'll find at the Harris County Clerk's Office website, which is here:

http://www.hcdistrictclerk.com/Edocs/Public/search.aspx

For those too dull witted to recognize it otherwise, I am seriously asking why isn’t the medical community policing itself?

The honor system is unreliable.

There’s the first problem.

Well....But we don't use the honor system to police the medical community in this country.

So, no. It's not.

@chris, I'm not the one(s) spending copious amounts of time spewing on the internet for no apparent reason other thane self gratification it seems. But yes, where I feel it's appropriate, I write letters, or try to do more than pontificate.

@ann, speaking of dull witted, I supposed you missed the link to the article orac posted that blamed in part the failure of the medical board for the egregious lack of action re: neurosurgeon and compared it to Burzynski? or the part where they can't investigate if there aren't complaints? I'm pretty much done responding to the sophomoric attempts at debate. It's like arguing with a 7th grader.

kc: I’m not the one(s) spending copious amounts of time spewing on the internet "

Please tabulate your contributions versus mine in the last twenty four hours. I believe you have posted more comments here than myself.

So what is your solution? What have you done to achieve that solution?

I would expect at least sanctions or malpractice lawsuits. I don’t see even those, though I didn’t do an extensive search.

It's very difficult to tease out, but from here it looks a lot like Count Scamula settled with Lola Quinlan. There were two causes in the 269th District, Nos. 201203429 and 201203429A. It looks like Scamislaw was not faring well in the former, leading to the severance attempt in the latter. The First Court of Appeals file for the (interlocutory, which is uncommon) appeal is here.

Most of these links go nowhere. Note also that Quinlan represented by her original attorney, Gibson, and Jaffe here, who was representing BRI in the original action. As with these documents, most of those in the 201203429A action are toast. I can't really see any way around it but a settlement. Moreover, if BRI was severed from the action, it's not going to show in the SEC filings.

^ "was represented"

One can search for the 269th District cases here (just use "Quinlan" and "Burz" as the party names). A login is required in order to view documents.

Ah, now I see that some of this ground has already been covered.

@ kc

graphic novels – nothing, they make excellent compost.

I doubt it. All of these inks...
And you may think you are smart, but the above sentence show how small-minded you are.

Guess I’m just obtuse Indigo, which is damn funny given where my IQ stands on a bell curve.

Anybody with a passing familiarity with potential energy would realize that the only option here is 100.

As usually, I forget to check my esses before posting the above quip. The astute reader will realize my sentence has two places where it could have used an extra 's'. I'm fine with both, so pick the one you prefer.

"Quinlan represented by her original attorney, Gibson, and Jaffe here, who was representing BRI in the original action."

I wonder how that happened. I would have thought both parties would have objections to his switching sides.

@ann, speaking of dull witted,

I prefer to think of myself as literal-minded.

I supposed you missed the link to the article orac posted that blamed in part the failure of the medical board for the egregious lack of action re: neurosurgeon and compared it to Burzynski? or the part where they can’t investigate if there aren’t complaints?

No, I saw them. But the words you used were "medical association."

Thanks for your clarification. The amended answer is that the most recent investigation by the medical board of which I'm aware ended without a finding of fact on the substance of the issues charged because the defense successfully argued that Burzynski himself was not personally responsible for the actions in question.

You can read about the charges here:

http://blogs.houstonpress.com/hairballs/2014/01/burzynski_texas_medical…

Also, speaking of dull-witted and/or literal-minded:

I believe you misunderstood Orac's meaning. It's possible for them to investigate without complaints by third parties. And they may be doing so even as we type, for all I know. But it's not typical for them to do so, because they don't really have the resources, staff or funding for self-starting investigations. So they largely rely on the press and public.

That's also true for the FDA, the EPA and -- ftm -- the IRS and any number of other state and federal bureaucracies, to a greater or lesser extent. Enforcement dollars are limited. The squeakiest wheel gets the grease.

I’m pretty much done responding to the sophomoric attempts at debate. It’s like arguing with a 7th grader.

I didn't know I was debating. I just thought I was answering your questions. (You're welcome, by the way.)

But thanks for your candor and charm.

@kc

Yes, as a matter of fact, I have written to my elected reps and the Texas MB several times about SB's egregious ways.

But at the moment, I'm mostly occupied by trying to manage a full time job and providing support for my father while he's fighting leukemia, so I've had other things on my mind.

kc appears to believe s/he was debating two propositions:
1) I'm smarter than any of you.
2) the Burzynski clinic is not engaged in fraud.

Of course, kc only made insinuations as to the second proposition, Just Asking Questions instead of actually stating a claim, so it's not surprising that commenters thought they were answering questions instead of engaging in debate. I took debate in high school too, and we always stated the proposition we were attacking or defending, but I suppose different schools have different approaches.

Evidence for the first proposition: kc knows how to spell ad hominem. Evidence against: s/he doesn't know what it means (Johanna's comment on kc's behavior was not a logically invalid argument against a proposition because it was not an argument at all and kc had not presented a proposition as s/he was Just Asking Questions).

Evidence for the second proposition: (a) kc's assertion that if Burzynski were engaged in fraud, then there would be lawsuits and sanctions against him and (b) kc's claim that we were unable to produce evidence of lawsuits and sanctions against him.

Of course, we did produce evidence of at least one lawsuit: Lola Quinlan's. I notice kc didn't have a word to say about that. And Burzynski has been charged with insurance fraud, and more recently his antineoplaston operation has been shut down.

Moreover, the conditional statement doesn't even make sense. Was Al Capone guilty of nothing but tax evasion? The fact that the authorities can't seem to stop someone doesn't mean his actions are not fraudulent.

It always makes me laugh when someone makes themselves look a twit (an ill-mannered twit in this case) and then manages to look even more foolish by pompously explaining how clever and well-educated they are.

To say nothing of the illogic of hating on graphic novels in this context.

@ Johanna

I'm sorry to read that about you dad.

@ Brook

To say nothing of the illogic of hating on graphic novels in this context.

It was just a roundabout way for kc to insult its opponents by implying they have the mind of a small child. But it just shows it doesn't go out much.

Maybe we should ask Darryl Cunningham to write a graphic novel on Burzynski.

One also cannot help noticing a certain pattern:
- straight answer by a regular: "it's just your opinion, don't you have facts?"
- link to another thread (full of links to facts): "it's just someone else's opinion, are you unable to have ideas on your own?"
- link to the FDA website: "Poo, they are corrupt, that they are saying has no credibility"
- link to a complaint, as asked: silence.

One is forced to conclude there is no pleasing kc.

@Helianthus

Thanks. It's all very crazy but he's being treated at UCSF and I must say, if you're going to fight cancer, that's a great place at which to do it. Things are looking kind of bleak, but it's not too late yet. (So if I seem prickly, that's probably why...)

oh please, just call me a poopey-head, you know you want to. I'm going back to the grown up table now.

Of course, we did produce evidence of at least one lawsuit: Lola Quinlan’s. I notice kc didn’t have a word to say about that.

sorry, that should be quoted and attributed to LW.

@KC,

Me think you have a thin skin...

Alain

oh please, just call me a poopey-head, you know you want to.

Heaven forfend. But if I did or said anything to give you that impression, by all means, please bring it to my attention so that I can apologize for the discourtesy.

I’m going back to the grown up table now.

As you wish.

I wonder how that happened. I would have thought both parties would have objections to his switching sides.

He didn't. If you look at cause 201203429A, Quinlan is represented by Scamislaw's attorney Hughes, with only Robin Reid still having Gibson as counsel. This is very good reason, if you ask me, to think that Quinlan had already agreed to a settlement from the Burzynski entities proper to keep BRI, which has to make public disclosures, out of it.

I'll note that kc flounced fairly promptly after having had evidence provided of what he was demanding. And, courtesy of Josephine Jones, there's more.

The Richert case (which doesn't name BRI) is now set for a November 3 trial.

And, courtesy of Josephine Jones, there’s more.

I was over at the Harris County Clerk's website compiling those, even as you posted. But if it's okay to just use Josephine Jones's excellent work, that list also occurs in a....Well. In a list form, in this post here:

http://josephinejones.wordpress.com/2013/05/13/burzynski-the-false-prom…

Or, for ease of reference:

Has Burzynski been sued by patients?

Yes. The following patients (or their families) have all sued Burzynski: Kay Wimberley, Christina Bedient, Gail Middleton, Lilly Louise Adams, Lola Quinlan, Robin Reid (and more recently, Meridee Richert). Hamilton was wrong to claim that these lawsuits were all frivolous and accusatory and all dismissed. For example, Kay Wimberley’s parents, Stanley and Bernice Zabodyn, received a $300, 000 settlement.

However, it's also generally true that what's in the record isn't necessarily indicative. Settling out of court is more the rule than the exception.

"oh please, just call me a poopey-head, you know you want to."

All the best debaters close with that statement. It's like "Carthago delenda est", only more ... special.

Of course, I like to think that I or my commenters would use a higher class of insult.

I think it's conceivable that there might be times when "poopey-head" would simply be the mot juste, which would automatically imbue it with class.

I can't say I'm anticipating that, exactly. But neither am I ruling it out.

@helianthus - oh, I know why kc flung poo. Graphic novels just struck me as particularly funny in this setting. It wasn't even effective as an ad hominem attack. For all s/he/it knows, I could share their opinion. Or I could be Joe Sacco, Alison Bechdel, or David Selznick happily making my living writing great books. (I'm on one of the kiddos touch screen devices. I'm too lazy too learn how to neatly hyper link in apple so you'll have to do your own duck duck go)

@ann

Sometimes, if you throw a "poopey-head" into an argument it so surprises/distracts the other person that you both have time to consider what you're really arguing about.

Perhaps I had a deprived childhood -- and adulthood -- but I learned the word "poopie-head" on Respectful Insolence. I have not yet had occasion to use it.

Sometimes, if you throw a “poopey-head” into an argument it so surprises/distracts the other person that you both have time to consider what you’re really arguing about.

Hence the old mnenomic couplet:

To render minds occupi-ed
Call other people "poopey-head."

Or maybe I just made that up. I forget.

Or maybe:

Il ne sait pas sur le pied
danser. I called him "Poopey-head."

“poopey-head” would simply be the mot juste, which would automatically imbue it with class.

Merde-tete!

Hmm, "pen cachu"

Nah, it just doesn't work in Welsh.

I'd like to address the folks who seemed to be convinced that S.R. Burzynski's Antineoplastons have never been scientifically tested and/ or that ANP has never been tested or passed any FDA approved clinical trials.
If you do your research, you'll find that ANP has undergone and passed Phase 1 and Phase 2 Clinical trials….for the less informed, Phase 1 means testing for safety, Phase 2, for efficacy (is it effective).
The FDA allowed a 10 person quota for children with DIPG (brainstem tumors) to have access to ANP but stopped access to new patients circa 2012.
In other words, there were and are still people receiving this "non-effective" drug as it appears to be keeping them alive well after their original prognosis..in some cases children surveying over two years after given 6 months to live.
Also, I read one persons blog inferring that people who choose not to be "guinea pigs" in a clinical trial by submitting themselves to unproven methods are infringing on getting pharmaceuticals tested properly…are you serious?
My wife has been to ALL the major cancer centers in the USA and ALL the doctors say there is no standard treatment that will save her life…and currently, there are no clinical trials proven effective (let alone safe) that can with inoperable brainstem tumorsr!

I'd like to think we have choice as Americans, i.e. decide how we want to live *or** die for that matter.
One must ask the question, "if Burzynski is a fraud or more importantly, if ANP is ineffective, why are human beings still receiving the drug?"

I'm sure my comments will not have any impact on the mentality on a website dedicated to drama and propaganda!

ORAC, "Big Brother Is Watching You!" G. Orwell, 1984

Her's some had evidence:
NARRATOR (reading along with title card of Dr. Nicholas Patronas):  During this trial, one of the National Cancer Institute’s leading experts, Dr. Nicholas Patronas, a board-certified radiologist since 1973, professor of radiology at Georgetown University, and founder of the neuroradiology section of the National Cancer Institute [SOURCE: NIH Staff Pages]—recognized the absurdity of the Texas Medical Board’s case against Burzynski, put his own career on the line and flew himself to Texas to testify on Dr. Burzynski’s behalf. Dr. Patronas testified under oath his role at the National Cancer Institute.
NARRATOR (reading along with the official court transcript from the May 24, 1993 hearing): [SOURCE: Original complete court transcript of the entire testimony 1993]  Q (Jaffe): Basically, just in layman’s terms, you do all of the imaging work and interpretation for the National Cancer Institute’s testing of drugs?  A (Dr. Patronas): Exactly. That’s my job, to assess the effectiveness of the drugs that are given there.   Q (Jaffe): Did there come a time when you became aware of Dr. Burzynski?  A (Dr. Patronas): Yes, the National Cancer Institute asked me to join a group of other physicians and scientists, and come to Houston on a site visit to Dr. Burzynski’s Institute. I was called as an expert in assessing the images to evaluate the effectiveness of his treatment. The basic conclusion, was that in five of the patients with brain tumors, that were fairly large, the tumor resolved, disappeared.   Q (Jaffe): And that’s part of what you do at the hospital, is to evaluate treatments on brain cancer patients? A: Well, since I am the neuroradiologist I see all brain tumors. And I see a large volume of them.   Q (Jaffe): You testified that five of the patients had their tumors resolved, they all...   A (Dr. Patronas): Disappeared.   Q (Jaffe): Disappeared? Can you give us some kind of context of that? How often does that happen? Just by spontaneous remission?  A (Dr. Patronas): I’m not aware that spontaneous remission occurs. The available treatments rarely produce results like that. The only medication, the only treatment, which I think is a last resort, is radiation therapy. Conventional chemotherapy is—provides very little, nothing, basically. So when this happens it is very rare. In these cases, all of the patients had already failed radiation.  Q (Jaffe): What happens with these patients, who failed radiation, with brain cancer?  A (Dr. Patronas): That’s it. They die.   Q (Jaffe): You are saying, that if someone has already failed radiation, there’s not much else?  A (Dr. Patronas): Nothing to offer, exactly.   Q (Jaffe): And there is nothing that you can do at the National Cancer Institute?  A (Dr. Patronas): Nothing we can do, not at this present time.   Q (Jaffe): What about these five patients? How come they lived?  A (Dr. Patronas): Well, it’s amazing, the fact that they are not handicapped from the side effects of any treatment, and the side effects of most aggressive treatments are worse than the tumor itself, so these particular individuals not only survived, but they didn’t have major side effects. So I think it’s impressive and unbelievable.   Q (Jaffe): How many times have you seen this in your experience? How often does this happen?  A (Dr. Patronas): I don’t. I have not seen it at any time.   Q (Jaffe): Now, let me ask you your opinion or advice. Based on what you have seen, what would happen, let’s say, for some reason Dr Burzynski’s brain tumor patients can’t get his medicine anymore, and have to go off treatment. What’s going to happen to them?  MR. HELMCAMP (prosecutor): Objection, Your Honor, not relevant.   MR. JAFFE (defense): I think it is relevant. That’s really the issue we are advocating in this case.   JUDGE: Overruled.   A (Dr. Patronas): I think these patients will die. [SOURCE: Original complete court transcript of the entire testimony 1993 (same as above)] 

@David - so what exactly has been Burzynski been doing for the last twenty years since then?

If you do your research, you’ll find that ANP has undergone and passed Phase 1 and Phase 2 Clinical trials

No doubt you can show the results from those Phase 2 trials.

“if Burzynski is a fraud or more importantly, [...] why are human beings still receiving the drug?”

The question kind of answers itself.

@David Lauser, let's accept, for the sake of argument, that twenty years ago Burzynski had a spectacularly effective treatment for incurable cancers.

Why didn't he publish the results of his trials? Why didn't he license it so thousands -- millions -- of sufferers could be saved? Before you reply that the evil FDA and the evil Big Pharma wouldn't let him, I remind you that there are hundreds of nations in this world that are not the U.S. and are not answerable to the FDA. There are clinics around the world offering pretended cancer cures that the evil FDA and the evil Big Pharma won't allow in the U.S.; why not Burzynski's?

I remind you that doctors, oncologists, even employees of the evil FDA and the evil Big Pharma, die of cancer or see their family members die of cancer. How is it that for twenty years, every single Big Pharma company -- and their Little Pharma competitors -- has ignored a cure which would make billions for them?

So as not to repeat myself, I'll point out my three comments starting at

http://scienceblogs.com/insolence/2014/02/12/stanislaw-burzynski-and-th…

I notice that no Burzynski defender has replied to them. Perhaps you'd like to.

@LW - not only that, but his patents have expired....at this point anyone could pick up the research and press on. So why haven't they?

Yep, I mentioned that in previous comments but, strangely, Burzynski defenders don't acknowledge it. Weird, isn't it?

Also, no discussion of Burzynski would be complete without this link:

http://theotherburzynskipatientgroup.wordpress.com/

The stories are painful to read, but are a must for anyone even considering dealing with Burzynski.

A quick note. You guys do realize that David Lauser is Liza Cozad's husband, don't you? Just to make sure you are all aware. Be civil. Mr. Lauser is going through a horrible time now with his wife. However, even though I recognize that and feel great sympathy for him, I can't let what he wrote about Burzynski go unanswered.

I fully understand his sadness and desperation. Although I haven't felt it for my wife, my wife and I did experience it when my mother-in-law's breast cancer recurred in a widely metastatic form. I understand the feeling of wanting to try anything and wanting to believe. Unfortunately, there's zero evidence that Burzynski can help Liza, and lots of evidence that he can't. Those clinical trials are shams, I'm afraid. If you don't believe me, believe Stanislaw Burzynski's lawyer. As I documented several months ago, here's what Burzynski's lawyer, Richard Jaffe, wrote about them in his book about defending alternative medicine practitioners. The longest chapter was about Jaffe's defense of Burzynski during the 1990s, and this is what Jaffe wrote about Burzynski's clinical trials:

So we decided to hit the FDA with everything at the same time. All of his current patients would be covered in a single clinical trial which Burzynski called “CAN-1.” As far as clinical trials go, it was a joke. Clinical trials are supposed to be designed to test the safety or efficacy of a drug for a disease. It is almost always the case that clinical trials treat one disease.

The CAN-1 protocol had almost two hundred patients in it and there were at least a dozen different types of cancers being treated. And since all the patients were already on treatment, there could not be any possibility of meaningful data coming out of the so-called clinical trial. It was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment. The FDA wanted all of Burzynski’s patients to be on an IND, so that’s what we did.

And:

CAN-1 allowed Burzynski to treat all his existing patients. That solved the patients’ problems, but not the clinic’s. A cancer clinic cannot survive on existing patients. It needs a constant flow of new patients. So in addition to getting the CAN-1 trial approved, we had to make sure Burzynski could treat new patients. Mindful that he would likely only get one chance to get them approved, Burzynski personally put together seventy-two protocols to treat every type of cancer the clinic had treated and everything Burzynski wanted to treat in the future…Miracle of miracles, all of Burzynski’s patients were now on FDA-approved clinical trials, and he would be able to treat almost any patient he would want to treat!

Burzynski's ideas might have made sense at one time, but unfortunately they have failed the test of time and science. It pains me greatly to say this, because I know that's not what Mr. Lauser wants to hear, but it's true.

One other thing. That testimony from Dr. Patronas is over 20 years old. When Liz Szabo tried to contact Dr. Petronas for her USA Today story about Stanislaw Burzynski, she found that he didn't want to talk to her and basically hid behind NIH PR flacks, who gave Ms. Szabo a canned statement. It would appear that Dr. Patronas is no longer so enthusiastic about Burzynski. I only tell Mr. Lauser this because I think it's important for him to know if he's citing 20 year old testimony from him.

@Orac, I didn't know. Thank you.

@David Lauser, I apologize for my snarky tone. But I do urge you to read the stories at The Other Burzynski Patient Group.

Neuro Oncol. 2007 October; 9(4): 467–602. » MP-01. A CASE REPORT OF A COMPLETE RESPONSE AND 20-YEAR SURVIVAL OF A PATIENT WITH A RECURRENT DIFFUSE INTRINSIC BRAINSTEM ANAPLASTIC ASTROCYTOMA
Neuro Oncol. 2007 October; 9(4): 467–602.
doi: 10.1215/15228517-2007-039

MP-01. A CASE REPORT OF A COMPLETE RESPONSE AND 20-YEAR SURVIVAL OF A PATIENT WITH A RECURRENT DIFFUSE INTRINSIC BRAINSTEM ANAPLASTIC ASTROCYTOMA
Stanislaw Burzynski, Robert Weaver, and Barbara Szymkowski
Author information ► Article notes ▼ Copyright and License information ►

Review date: . Status:

High-grade diffuse intrinsic gliomas of the brainstem (HDBSG) that recur after radiation therapy carry a grave prognosis and have a median survival of less than 7 months. This presentation describes an unusually lengthy complete response (CR) of a 36-year-old female with HDBSG treated with Atengenal and Astugenal (ANP) which consist of synthetic analogs of naturally occurring phenylacetylglutamine, phenylacetylisoglutamine, and phenyl acetate.
The patient was diagnosed with a pontine glioma in June 1987 and biopsy performed on July 25, 1987, at UCSF confirmed an anaplastic astrocytoma. She was treated with hyperfractionated radiotherapy for a total dose of 76 Gy, which was completed on October 9, 1987. In February 1988, she developed diplopia, right facial paralysis and vertigo. A MRI of the head on February 25, 1988, showed interval enlargement of the tumor with extension to the right anterior pons and middle cerebral peduncle.
No further therapy was recommended at UCSF due to her tumor progression, and on May 23, 1988, she began treatment with ANP. On May 29, 1988, a low dose of methotrexate 7.5 mg PO daily (0.1 mg/kg/d) in five days on/off courses was added to ANP. On July 12, 1988, methotrexate was discontinued and she continued intravenous infusions of ANP only (the maximum dosage of Atengenal was 0.8g/kg/d and of Astugenal was 0.2g/kg/d). Intravenous ANP were discontinued on August 10, 1989 and replaced by oral ANP (the maximum dosages were 0.14g/kg/d).
All treatment was discontinued on January 21, 1990. Follow-up MRIs revealed gradual decrease and eventual disappearance of the tumor on January 23, 1989. Numerous subsequent MRIs confirmed CR. ANP was well tolerated with only minor reversible side effects including a skin rash, fever and slight leukopenia from which she recovered completely except for a mild right facial nerve paresis, which occurred after the initial tumor biopsy. She is currently doing well and has not suffered from any chronic toxicity related to ANP.
Periodical repeat MRIs of the head (the last on April 28, 2007) have shown no tumor recurrence. The National Cancer Institute (NCI) confirmed her diagnosis and CR during a site visit. ANP is a multitargeted therapy, which is currently pending use in Phase III trials in newly diagnosed diffuse intrinsic brainstem gliomas.
•
1.

All treating "AMA" Certified Oncologists say my wife will die form her brain tumor and that there is no cure with standard medicine.
ANP has passed Phase 1 & 2 Clinical trails…with no significant side effects and Dr. Burzynski has offered all treatment at no cost, i.e free!
Even if it doesn't work, Liza has the right as a citizen to freedom of choice.
Hey, if she dies after treatment, then the FDA has more cannon fodder…yes?
I say it is suspect that there's such a block on getting access, especially when I know for a fact that there are patients receiving it now…this isn't for the general population per se…and we aren't trying to set a precedent….Liza deserves a shot at this even if it just to make her feel empowered!

Nuff said….

Mr Lauser,
I am truly sorry your wife is so sick. I don't know the pain and desperation you must be feeling, but I remember what it was like watching my sister-in-law die of cancer 3 years ago.
I definitely sympathize with you.
But unfortunately, Dr Burzynski hasn't published the results of any of those Phase 2 trials so we have no evidence how effective or ineffective the ANP treatment is.
And at least one person has died from ANP itself.

That is why the FDA has stopped him from accepting patients.

I wish there were a way to empower Liza and I wish there were a way for her to enroll in a different experimental trial.
Unlike Dr Burzinski, most such trials are at no cost to the patient.

But, I would ask if you would please, has the Burzinski clinic quoted a price to you for this treatment?

Again, you have my deepest sympathy and that of many other commenters at this site as well.

Dr. Burzynski has offered all treatment at no cost, i.e free!

If this is meaningfully true, as opposed to Burzynski's well-known attempts to segregate charges from himself and the Burzynski Clinic, the Burzynski Research Institute, and the grossly inflated charges from the in-house Southern Family Pharmacy, it reflects even more poorly on Burzynski. He's never offered charity care. If he suddenly is now, the only explanation is that he smells publicity: he wants to take advantage of you, who are in a very vulnerable position, in a different way.

"ANP has passed Phase 1 & 2 Clinical trails…with no significant side effect"

As squirrelelite points out, the results of those trials have never been reported. We have only rumors that they were successful. Why has Burzynski chosen never to report his results?

But also -- it is entirely false that there are no significant side effects. At least one patient died from hypernatremia; that's why the FDA finally took action. Even where the patient didn't die of the treatment, the only way to keep their sodium levels down was to drink enormous amounts of water, which of course had to be excreted -- meaning their final months were spent running to the bathroom, not getting enough sleep because of the constant need for urination ....

Again, I urge you to read the stories at The Other Burzynski Patient Group. Those stories are mainly in the patients' own words, describing what their treatment was like.

I do feel sympathy for the desire of an adult to make her own health choices, even if they appear very unwise. But that doesn't mean that people should not be able to comment on those choices, in hopes of dissuading others from making the same mistake. And it certainly does not mean that people should not be able to criticize those who offer false hope.

"“ANP has passed Phase 1 & 2 Clinical trails…with no significant side effect”

Sounds like Dr. Charles NIchols promoting the heart drug Provasic in "The Fugitive". :)

With few exceptions, Burzynski's patents have expired.

With few exceptions, so have his patients.

ANP has passed Phase 1 & 2 Clinical trials

You have been lied to - since Burzynski has not published the results of these these Phase II trials, ANP has not "passed" anything. The fact that he has not published the results is strong evidence that ANP has failed.

Mr. Lauser:

I started to write a response, but it got so long that I decided to turn it into a new post. Please click on the link below to see what I have to say. Best wishes to you and your wife:

http://scienceblogs.com/insolence/2014/03/15/my-response-to-david-lause…

What incredible arrogance, inflated ego, and insensitivity has been displayed here. The case against the treatment has been presented. The simple truth is that Liza Cozad apparently has no options. She is an adult. So long as she is fully informed, she should have the right to determine what happens to her. It may not be your choice, but that's precisely the point. It's not your choice to make for anyone but yourself. There is no attempt here to provide access to any one but her. If the clinic provides the treatment pro bono, there is no financial argument. Even if they do not, you have to right to decide how you spend your own money, not how anyone else spends theirs. Not to be callous, but where is the downside? She is terminally ill. At worst, she dies and provides more data against the clinic and fodder for bloggers ad nauseum. Why would any rational person think they have the right to impose their choices on Liza Cozad and why would any rational person accept it?
To quote CS Lewis: "Of all tyrannies, a tyranny sincerely exercised for the good of its victims may be the most oppressive."

What an incredible lack of reading comprehension, FTW.

The issue is that Burzynski is attempting to use emotionally charged cases (such as Liza) to circumvent the FDA's very reasonable (and evidence-supported) block of further ANP "one-person trials." If Burzynski had bothered at all to follow the well-justified clinical trial procedures, perhaps Liza and other patients could make a "fully informed" choice.

This may be a case where the slippery slope argument is actually appropriate.
One person has already died from the effects of this treatment. And many more have paid hard earned and donated money to be treated this way with no evidence of effectiveness.
So, the FDA has stepped in to stop the show.
But now Liza Cozad says, "I'm and adult and I'm dying anyway and I want to pay my money and take my chances Please give me the treatment."
So, the FDA gives in and says, "OK you can have it but no one else."
But then the next dying patient complains, "you let Liza have it, why not me?"
And so it goes on and on the way it has been for years.

So the FDA finally steps in and says, "Enough already, no more ANP treatments to anyone else."

Which is what they have done.

There is a way for Liza Cozad to get ANP.

It would require a researcher or institution not affiliated with SB to submit a new PII trial design to the FDA and request permission to proceed with a trial. They would not need SB permission as the compounds in question are no longer under patent. There is precedent for this, from the FDA website:

"In 1991, the National Cancer Institute (NCI) reviewed some of Dr. Burzynski’s cases and decided to conduct clinical trials on antineoplastons at cancer centers. By August 1995, only 9 patients had enrolled and the clinical trials were closed before being completed.

4 years, 9 patients. I believe this trial has been discussed here in greater detail . Strange that such an allegedly effective compound failed to generate any interest from oncologists or patients once it was out of the hands of SB himself. Strange only until you realize that SB is a scam artist.

I'm not being serious. I'd be surprised if you could find a willing oncologist with research capabilities who would be interested in pursuing this research dead end. Even if it came all bow wrapped with funding included courtesy of rock concert fund raisers.

The fact that no other place on the planet is pursuing this approach speaks to the paucity of real evidence that SB has put forth.

Either he is a scam artist spouting lies about the effectiveness of his treatments, or he is a monster for withholding this treatment from the world for personal gain. If you favor the later, then he is a foolish monster, because he certainly could have made a lot more money by licensing out this wonder treatment and selling it globally.

I found the results of the NCI trial that was abandoned after 9 patients.

http://www.ncbi.nlm.nih.gov/pubmed/10069350?dopt=Abstract

RESULTS:

Nine patients were treated, in six of whom the treatment response was assessable in accordance with protocol stipulations. No patient demonstrated tumor regression. Reversible grade 2 or 3 neurocortical toxicity, consisting of transient somnolence, confusion, and exacerbation of an underlying seizure disorder, was noted in five patients. Mean steady-state plasma concentrations of phenylacetate and phenylacetylglutamine after escalation to the target doses of A10 and AS2-1 were 177+/-101 microg/mL and 302+/-102 microg/mL, respectively. Patients who exhibited confusion tended to have higher phenylacetate levels.

CONCLUSION:

Although we could not confirm any tumor regression in patients in this study, the small sample size precludes definitive conclusions about treatment efficacy. Antineoplaston-related toxicity was acceptable in most patients with appropriate dose modification, although severe neurocortical toxicity may occur. Steady-state plasma concentrations of phenylacetate with use of A10 and AS2-1 were similar to those reported with use of similar doses of phenylacetate alone.

I’d be surprised if you could find a willing oncologist with research capabilities who would be interested in pursuing this research dead end.

Particularly given that they seem lately to be playing back up the angle that antineoplastoids are HDAC inhibitors rather than cytotoxic. (I note with mild amusement that this patent (non-Burzynski) disagrees in passing (¶ 259).

That ship has long left Burzynski past the horizon.

Stanislaw Burzynski’s counteroffensive against the FDA and Texas Medical Board continues, part 2

oracknows — Thu, 30 Jan 2014 07:45:07 +0000

Stanislaw Burzynski’s counteroffensive against the FDA and Texas Medical Board continues, part 2

Believe it or not, I'm about to say the one and only good thing I will say about Stanislaw Burzynski in this post. After all, I was always taught to find the good in my opponents, no matter how vile I find them. Burzynski, for instance, has been peddling a cure for brain cancer (and other cancers) that he claims to have discovered in the blood and urine in the 1970s. Despite there being no convincing evidence of antitumor activity due to these peptides, which he dubbed antineoplastons, he has managed to win battle after battle with the FDA and the Texas Medical Board and to continue to prey upon desperate families of patients dying of brain cancer. So here's my one and only node to Stanislaw Burzynski. In the interview that I'm about to discuss, the host, Patrick Timpone, asked Burzynski about Tullio Simoncini and whether he thought there was anything to his cancer treatment. If you recall, Simoncini claims that cancer is a fungus and that sodium bicarbonate is the cure for cancer. I've dissected his idiotic claims before. Burzynski rejected it with that characteristic contempt he is so good at demonstrating, with a "No, no, no, I don't think that would have a chance."

Very good. That much, at least, Burzynski and I agree on about cancer. Simoncini is too loony even for Stanislaw Burzynski. Will small miracles never cease? Unfortunately, credulous stories about Burzynski patients definitely seem never to cease, for example Saving McKenzie Lowe: How You Can Help by Carol Robidoux and Grandfather goes to Washington to try and save ill Hudson granddaughter by April Guilmet. Both of these credulous journalists need to listen to an interview by Burzynski and his minions to see just how conspiratorial and full of hate they are.

So what is this interview I'm talking about? Well, the Burzynski propaganda machine, even as diminished and battered as it is in the wake of the USA TODAY report by Liz Szabo in November, still exists and has been on the road. To fire it up for the new year, Burzynski appeared on an Internet radio show hosted by the perfect host to interview him, a man so credulous, so gullible (or perhaps clever, depending on how you view his promotion of all manner of quackery on his website), so full of magical thinking that during the interview his nose was planted so far up Burzynski's rectum that even pushing a colonoscope up to Burzynski's ileum might not have located it. Patrick Timpone was just that credulous in his January 28 interview with Burzynski and minions.

Joining Burzynski were some of the usual suspects: Eric Merola, Burzynski's propagandist, the man who made two hagiographies of Stanislaw Burzynski (part 1 and part 2) painting him as a brave maverick doctor and the only doctor who can cure certain types of brain tumors; Ric Schiff, a San Francisco police officer who believes that Burzynski saved his little girl Crystin from a brain tumor but that conventional radiation therapy and chemotherapy killed her; Mary Jo Siegel, whom we've met before, a woman who thinks that Burzynski saved her from non-Hodgkin's lymphoma; and Donna Navarro, a woman whose son with a brain tumor died from apparently treatment-related causes back in 2001, the result of which was her participation in a movie known as Cut, Poison, Burn. I haven't really encountered her, but I've been meaning to watch the movie, which has been available online for a long time now. Maybe this will finally tweak me to do it.

In the meantime, I was curious what the Burzynski machine was up to. So I listened to the interviews, which encompassed nearly two and a half hours, so that you don't have to. Or you might want to. I don't know. As I sat in my office working on a grant earlier today, in the background I heard Burzynski's soothing Dracula-like voice and then the voices of his acolytes, all of whose voices have become unfortunately familiar. A lot of it I've heard before. Some of it I haven't. I'll try to hit the high points.

The first thing that became apparent to me listening to this radio interview is just how much Burzynski hates skeptics. He started out all pleasant and smarmy, telling Timpone to "ask me questions," and rapidly let his contempt become painfully obvious. Before the eight minute mark arrived, he had started a tirade where he refers to an "army of hooligans" who are "funded by big pharma" to orchestrate a "smear campaign" and who are "smearing us mercilessly everywhere." Yes, that's us skeptics. It actually rather warms the cockles of my heart to know that Stash cares about us enough to call us "the army of crooks called skeptics." It tells me we've been effective. I got a particularly warm, fuzzy feeling inside when Burzynski went all Godwin on us and said:

They learned form Nazis. They learned from Mr. Goebbels before World War II and are using the same tactics. They smear us at every step. They lie.

Then, typical of Stash, he makes the grandiose claim that by the end of the year we will all be gone. Why? It's not clear, but he implies that something will happen this year that will vindicate him. I can hardly wait. I won't bore you (too much, anyway) with the rest of the interview, because there's very little there that I haven't heard before. He tells a highly biased story of how he discovered antineoplastons. Then there's the same nonsense about the "Japanese trials" that I dissected when I reviewed the second Burzynski movie by Eric Merola. Interestingly, he lets it be known that these trials were funded by an unnamed wealthy donor, not by any sort of competitive grant funding. Then there's the same claim that he has been permitted to undertake phase III clinical trials of antineoplastons. Actually, as has been explained so many times in so many places that phase III trial never opened. It never accrued a single patient, despite being opened in December 2010. If you look for it on the ClinicalTrials.gov website, you'll see that its status is now listed as "This study has been withdrawn prior to enrollment," which means the study was halted prematurely, prior to enrollment of first participant. The study was last updated September 16, 2013, which is presumably when it was withdrawn. Basically, here Burzynski is either deluded or lying. Take your pick.

Other tunes on the Burzynski greatest hits album came fast and furious. The phase II trials are finished. (Then why haven't the final results of any of them been published?) According to Burzynski, hundreds of patients with inoperable brain tumors have been saved by antineoplastons. (If true, then that should be easy to prove. So why hasn't Burzynski proven it?) Antineoplastons are available in Japan and Australia, where all a doctor has to do is to call up the Japanese or Australian equivalent of the FDA and ask for a compassionate use exemption and you'll get it. (I'm going to have to look into this one sometime.) Burzynski rants about the FDA requiring that patients undergo the standard of care for brain tumors and failing it before they can be enrolled on antineoplastons. This, of course, is standard practice because it would be unethical to go straight to an experimental treatment without first having tried effective medication, even if its effectiveness leaves something to be desired. Burzynski claims that his results show that patients who get antineoplastons first do much better than those who receive them after chemotherapy, a claim that, again, if it were so obviously true as Burzynski claims should be easy to demonstrate from his data. He hasn't, which is why I wonder if Burzynski even knows what the term "selection bias" means. Of course patients who have tumors that haven't responded to chemotherapy will appear to do worse.

Most amusing of all (to me), Burzynski also claims that brain tumors "shrink away" within weeks. Little does he know that that claim looks more than ever to me like pseudoprogression, where inflammation from previous treatment, particularly radiation therapy, mimics tumor progression, which then naturally regresses over the course of—you guessed it!—four to eight weeks. More than ever, I'm convinced that many of Burzynski's "success stories" are him mistaking the regression of pseudoprogression for a real antitumor effect due to antineoplastons.
But, hey, according to Burzynski, we have "totalitarian medicine" and the system in the United States is "like the Nazi system of medicine," with everybody treated the same same way "to the glory of pharmaceutical industry and to the glory of the government, which tells them what to do."

Stash sure does like his Nazi analogies. I will give him credit, though, for an insufferable sense of how to tell everyone that they are peons and he is an Important Man. At the end of his segment, he says he has to leave because he has important people waiting for him who flew halfway around the world to see him. Nice.

Eric Merola showed up next, and I don't really have a lot of stomach for going through his nonsense except briefly. I've heard it all before and probably related most of it to you before. The only difference is that his "Zeitgeist" self came out more, and he was more explicitly conspiratorial than I've heard him before. To him, the assault on Burzynski is like the IRS investigating Tea Party-affiliated groups. Meanwhile, all the old tropes keep coming, with Burzynski mentioning Nicholas Patronas, a high ranking radiologist at the NIH who wrote a letter of support for Burzynski 20 years ago. Too bad Burzynski seems unaware that Liz Szabo tried to contact Dr. Patronas and described their interaction thusly:

As I looked at Burzynski’s endorsements, they fell through, either because they couldn’t be verified or because people apparently now don’t want to publicly be associated with Burzynski’s claims. His supporters like to quote some early supporters at NIH. For example, Dr. Dieter Schellinger. He is now elderly and said he has no memory of Burzynski. Dr. Nicholas Patronas is still at NIH, but did everything he could to avoid being quoted about Burzynski, and basically said any of his earlier comments were about preliminary work from the 1990s, and not meant to assess efficacy.

Oops.

None of this stopped a Merola greatest hit parade, including claims that Burzynski is "unfair competition" and "they" had to eliminate them. (Given that Burzynski has been doing what he's doing for 37 years, "they" sure have done a crappy job. He did, however, try out a new excuse, mainly that the reason that the phase III trial was withdrawn was that Burzynski hadn't started it, despite having approached 300 children's hospitals and been told "no," the implication being that "they" closed ranks and refused to work with Burzynski. Of course, it's not implausible that Burzynski had to close the trial because he had failed to enroll a single patient in nearly three years, and it's certainly plausible that no reputable pediatric oncologist wanted to get within a mile of Burzynski, but none of it was a conspiracy. It does amuse me, however, Merola can't even be bothered to keep his story consistent with what Burzynski says. Remember, Burzynski mentioned nothing about the phase III trial having been closed and implied that it would happen if only he could get the money.

Up next was Ric Schiff, who told his story yet again. I do feel obligated to mention here that what Schiff is doing is a massive conflict of interest that was undisclosed. Nowhere was it mentioned in the interview that in July 2013 Schiff was elected to the board of directors of the Burzynski Research Institute. So not only is there an undisclosed conflict of interest here, but one wonders how legal his involvement with the lobbying organization he appears to be heading up, the ANP Coalition, which I discussed last week.

I've always found his story a bit confusing. His daughter Crystin, diagnosed with a very rare malignant rhabdoid received chemotherapy and radiation, responded, recurred, and was treated with antineoplastons. Tragically, Crystin ultimately died. Schiff keeps saying that she was cancer-free when she died and that the chemotherapy and radiation killed her, but interestingly, unlike so many other patients featured in Merola's movie, no medical records were included, nor was the autopsy report. Also interestingly, Ric Schiff states that the doctor who treated Crystin had testified in a deposition for one of Burzynski's trials that he had cured two of his patients. This appears to be in marked contrast to what a legal record shows, namely that the doctor had testified against Burzynski in a previous trial. I'm sure there's an explanation, just as there's an explanation for Ric Schiff's claim that he's met "hundreds" of patients saved by Burzynski. Again, if that's true, where are these patients, and why can't Burzynski demonstrate this in clinical trials?

In any case, Schiff and later Mary Jo Siegel (whose case I've discussed before) spent a lot of time talking about the ANP Coalition, the group whose mission is to promote antineoplastons and lobby Congress to pressure the FDA to allow clinical trials to begin again. In that, they really are trying to recreate the 1990s playbook, and why not? It worked so spectacularly last time, when Congressional pressure led the FDA to fold and allow Burzynski to open 72 phase II clinical trials, about which Burzynski's lawyer Richard Jaffe so famously (now) wrote:

So we decided to hit the FDA with everything at the same time. All of his current patients would be covered in a single clinical trial which Burzynski called “CAN-1.” As far as clinical trials go, it was a joke. Clinical trials are supposed to be designed to test the safety or efficacy of a drug for a disease. It is almost always the case that clinical trials treat one disease.

The CAN-1 protocol had almost two hundred patients in it and there were at least a dozen different types of cancers being treated. And since all the patients were already on treatment, there could not be any possibility of meaningful data coming out of the so-called clinical trial. It was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment. The FDA wanted all of Burzynski’s patients to be on an IND, so that’s what we did.

CAN-1 allowed Burzynski to treat all his existing patients. That solved the patients’ problems, but not the clinic’s. A cancer clinic cannot survive on existing patients. It needs a constant flow of new patients. So in addition to getting the CAN-1 trial approved, we had to make sure Burzynski could treat new patients. Mindful that he would likely only get one chance to get them approved, Burzynski personally put together seventy-two protocols to treat every type of cancer the clinic had treated and everything Burzynski wanted to treat in the future…Miracle of miracles, all of Burzynski’s patients were now on FDA-approved clinical trials, and he would be able to treat almost any patient he would want to treat!

I know I've quoted that passage before, but it can't be repeated too many times, as far as I'm concerned, particularly in the context of reporting on what Burzynski minions, sycophants, toadies, and lackeys are saying. Also, every time Ric Schiff shows up, I'll point out that he is on the Burzynski Research Institute board of directors, because he never appears to see fit to mention this little bit of information when he's out shilling for Burzynski. I do wonder, however, if he's happy that Mary Jo Siegel mentioned that the lobbyist the ANP Coalition hired, Antonio C. Martinez II, costs $10,000 a month. One wonders where the money for that is coming from, one does, because it doesn't sound as though the ANP Coalition itself is bringing in much money.

Clearly, in the wake of the USA TODAY story, the level of paranoia is escalating. In fact, I recommend publicizing these interviews to the people who write stories like this one:

Fed up with unreturned calls to the FDA, Frank LaFountain drove himself to Washington, D.C., on Tuesday in a last-ditch attempt to save the life of his 12-year-old granddaughter, McKenzie Lowe.

Diagnosed with an inoperable brain tumor known as Diffuse Intrinsic Pontine Glioma (DIPG), the Hudson sixth-grader has already outlived the average life expectancy for children suffering from the rare condition.

This past November, about a year after McKenzie's diagnosis, her family began the process of seeking federal permission to pursue a controversial and experimental treatment for the little girl's rapidly growing brain tumor after several unsuccessful rounds of chemotherapy and radiation.

The Lowe family is still holding out hope that McKenzie can obtain antineoplaston treatment at a Texas clinic.

The correspondent, April Guilmet, goes on to write about how New Hampshire senators, moved by McKenzie's plight, have written letters to the FDA on her behalf. Again, I understand the human impulse to help children like McKenzie Lowe. Only a heartless bastard could fail to be moved by her story. But stories like Guilmet's do not help McKenzie or any other patient with brain cancer, just as the stories being written about Elisha Cohen do not help him. She also credulously swallows Ric Schiff's version of events regarding his daughter and, worse, appears to completely buy into the narrative being promoted by Burzynski's propagandists that Burzynski is McKenzie's only hope—and the only hope for another child with a brain tumor named Braiden Norton. In fact, the latter case is even more disturbing, given this:

Doctors at Boston Children's Hospital performed surgery to remove most of the tumor, but gave the boy a 50 percent chance of survival after the mass, located on Braiden's brain stem, began to grow again.

Specialists at Dana Farber Cancer Center recommended a yearlong course of chemotherapy but after further research the Nortons knew they wanted to find a gentler alternative.

"What they were going to give to my kid was a poisonous joke," Phil Norton said.

Three days before Braiden's first scheduled chemotherapy treatment, the Nortons discovered the Burzynski Clinic. Though doctors at Dana Farber advised against it, the family was soon on a plane bound for Texas.

So this case is more akin to that of Sarah Hershberger, in that the parents appear to be throwing away a 50% chance of long term survival for woo. As we have seen so many times, Burzynski claims that there is "no trace" of the tumor, but given his record interpreting brain imaging scans (not good). Also not mentioned is that pylocytic astrocytoma, the tumor type that Braiden has, is generally considered a benign tumor and tends to be slow growing. According to the parents' website, Braiden's tumor was a "low grade, benign, Pylocyic Astrocytoma." It also shows that Braiden suffered at least one catheter related infection due to the Portacath used to administer the antineoplastons.

I may have to look into this anecdote in more detail.

Meanwhile, people like Carol Robidoux are writing similarly credulous articles like Saving McKenzie Lowe: How You Can Help, promoting the Burzynski line. Once again, as I've described it, Burzynski is using patients as a weapon and a shield against the FDA. Unfortunately for him, he can't see to keep himself and his minions from letting the conspiratorial crazy flow when the audience is for alt-med "health freedom" activists, perhaps thinking that the mainstream outlets that he depends on for stories like those written by Robidoux and Guilmet to promote his cause and use those same patients to tug at the heartstrings of readers and legislators like the two senators from New Hampshire. I suggest that everyone, particularly Robidoux and Guilmet, listen to Burzynski's interview and the interviews with his minions done by Timpone and read Liz Szabo's excellent story on Burzynski. Then resolve to show a little skepticism before writing another story on McKenzie Lowe or other Burzynski patients. You are not helping them, as much as you think you are. I understand the impulse to help a suffering child, but your energies will not help any of these children but will help Burzynski in his war against the FDA.

oracknows Thu, 01/30/2014 - 02:45

Categories

Medicine

More than ever, I’m convinced that many of Burzynski’s “success stories” are him mistaking the regression of pseudoprogression for a real antitumor effect due to antineoplastons.

Orac is generous in thinking that Burzynski is "mistaken".

LW could be right, but I'm trying not to make assumptions.

http://www.indiegogo.com/projects/bought-movie-matching-funds

@JD - interesting that the two main points in the anti-vax section contradict each other....1) that parents can't sue vaccine manufacturers for damages & 2) that over $2Billion dollars have been awarded as compensation

Another example of how the anti-vax brigade can't keep their stories straight.

Orac said:
"After all, I was always taught to find the good in my opponents, no matter how vile I find them".

Oh, I wasn't.

OT- but are pseudo-scientific posturings of self-centred, money-hungry wankers in TEXAS ever TRULY OT @ RI?

Today Mikey reveals his master plan in a long-ish video at Natural News:
- he has discovered that 'healthy' foods contain ((shudder)) heavy metals
- these contaminants cause many health issues- esp those that affect cognition, emotions and mental health
- this is what "dumbed down" modern society
- if you get 'clear' like he did, you will begin to comprehend the dire straits in which the world finds itself.
- there is massive debt
- we should make drugs legal so gangs don't take over
- clean foods will save the world

Follow Mikey and you too can triumph over brain fog

@DW

Is Mikey an AGW denialist?

Do you think any of the journalists* that have written these credulous articles can be turned around by evidence of the crazy conspiracy statements emanating from the Burzinski camp and the evidence that his "treatment" is ineffective? Or are they too heavily invested and the cost of admitted they were fooled is too high?

*I am beginning to think that the number of actual journalists (as opposed to credulous copy-paste churnalists) in North America is in the low double digits.

@ Militant Agnostic:

Mike doesn't buy AGW but hopes that you'll buy his fearmongering about other subjects:
contaminated food, evil doctors, gang warfare, a police state and economic Ragnarok- coming soon to a location near YOU..

About journalists:
I don't know but I think that our constant re-iteration of the truly unfettered madness that exists in woo might be a way to get the brighter ones to walk away.

As I always say:
woo needs conspiracy theories to explain why it is not accepted as the status quo since it is SO advanced and effective.
So we can hit them with both sides of crazy.

The fact that "we will all be gone by the end of the year" because "something will happen this year that will vindicate [Burzynski]", causes one to reminisce about Mikey's big announcement on Jan. 6 (or was it 7) that--ahem--changed the way we think about science.

Burzynski seems to have a 37 year fantasy that indeed, oncology as we know it will by supplanted by him, soon.

Just prior to his Big News, Mikey wrote this for Natural News and Info Wars:

Historical deep freeze across North America proves global warming is getting worse, right?

@Denice,

I'd be tempted to reply if he has heard of the word homeostasis? It work for mother nature too.

Alain

Mr Woo thinks that reading about this man is making me too stressed. Sadly, I've also wandered into reading about other woo that is equally damaging/deadly and its results, so I don't think it is just Dr Burzynski.

I think reading the two articles trying to get help and support for the children depressed me even more? As long as he keeps doing the "maverick doctor" bit, there is a subset of the population that will be willing to believe that it's "the Man keeping the good guy down," rather than some man selling snake oil to some of the most desperate and frightened patients you can find.

I wonder if Dr Burzynski was originally inspired to look at urine because of the woo of urine therapy?

To him, the assault on Burzynski is like the IRS investigating Tea Party-affiliated groups.

Is Merola claiming that Burzynski's critics are, as alleged of the IRS auditors, attacking him for improper reasons, or is he claiming that the accusations against Burzynski are as truthful as the allegations that the IRS was specifically targeting Tea Party groups? In the IRS case, it turned out that people in the Cincinnati office were investigating groups on both ends of the political spectrum, progressive as well as Tea Party, to see whether they were engaging in political activities not allowed under the section of the Internal Revenue Code they were using to claim tax-exempt status. So it's a strange analogy for Merola to make to an audience that gets their news from sources other than Fox News.

1. Burzuynski is not being nice or even rational about science when he says that Simoncini's fungus-cancer idea doesn't have a chance of being true. He's just trying to discredit a competitor for the desperate woo dollar.

2. It's not a smear campaign when people are telling the truth about Burzynski's bad actions. It doesn't take a conspiracy for real medical doctors to tell their patients to avoid someone who was once and is being currently investigated by the FDA for fraud and killing patients.

3. Burzynski and his defenders do project their mistakes onto others, however, in that it takes a conspiracy (in the legal sense) to hide Burzynski's medical malpractice by altering records and submissions to the FDA.

they learned from Mr. Goebbels before World War II
That's Dr Goebbels to you, sonny.

brain tumors “shrink away” within weeks.
Burzynski sounds like he's promoting a new weight-loss drug. See those pounds melt away!

and Donna Navarro, a woman whose son with a brain tumor died from apparently treatment-related causes back in 2001, the result of which was her participation in a movie known as Cut, Poison, Burn. I haven’t really encountered her, but I’ve been meaning to watch the movie, which has been available online for a long time now.

She's also gotten in on the Hershberger action.

I'll go ahead and say it: Dr. Burzynski is a sociopath. So of COURSE he gets nasty when challenged--he's being thwarted. Be prepared for the wheels to come flying off this woo machine if the FDA and the Texas Medical Association shut him down.

Denice Walter @5:
So Mikey is now 'clear' by detoxing or whatever it is he has done - I always thought that to get 'clear'(TM) you had to go through round after expensive round of Scientology auditing.

@ Derek:

Aha! SOMEBODY understood my choice of words!

I'm one of the reporters that you referred to in this post, and I invite you to contact me, at your convenience. My email address is AGuilmet@newstote.com.
Kind regards,
April Guilmet

This fight with Dr. Burzinski is all about money. Surgeons, radiologists, and the makers of standard chemotherapy drugs want the public to believe that Dr. Burzinski is a quack selling a completely bogus treatment. There is a very good reason why attempts to shut Dr. Burzinski down have encountered so many thorny problems. The courts and others asked to shut him down don't want to deny life-saving treatment to anyone. It's true that antineoplastons have risks and some patients don't benefit at all. But others have indeed benefited regardless of what the so-called experts and powerful special interests want to believe.

Kelly, let's say that you had $1million and you wanted to invest it. You look around and find a new product with an awful lot of publicity and personal recommendations. It seems too good to be true. How hasn't some big multinational taken this over by now? Then you find a lot of conspiracy theories around why this might not have happened. Would you then invest your money with no further investigation or would you dig a little deeper, look for evidence that this new product really does what it says? Real evidence?

Hi Kelly,
I'm not a surgeon, radiologist, or in any way connected with Big Pharma (other than having benefitted from chemotherapy myself), and I'm certainly no expert or powerful special interest. I'm *just* a cancer patient, but I also want the public to understand that Burzynski is a NONcologist selling a completely bogus treatment.

Where, exactly, can we see evidence of these patients that Burzynski's treatment has supposedly helped? Of course I mean other than the few patients uses for advertising purposes and whose cases have been discussed previously.

What is your stake in all this? Why do you promote someone who has been shown to take vast amounts of money from lots of desperate cancer patients with absolute zero evidence of any effective/safe treatment for their illness?

Oops - apparently the DNS error I keep getting didn't prevent my posts from appearing - sorry for duplicates!

@Kelly Clover - if you have good, peer reveiewed, replicated evidence that Dr. Burzynski's treatments have better clinical outcomes than the current standard of care for any particular disease, please share. Thanks!

@MoB - I agree, if these Dr. B supporters have access to "super-secret" clinical trial information showing efficacy of his treatments, they should be sharing them with the world....I wonder why they aren't?

This fight with Dr. Burzinski is all about money. Surgeons, radiologists, and the makers of standard chemotherapy drugs want the public to believe that Dr. Burzinski is a quack selling a completely bogus treatment.

ORLY? Where are they? The only people I see "fighting" with Burzynski are a handful of folks who increasingly started to take notice of him around the time of the Marc A. Stephens debacle. The FDA, you may recall, has facilitated the operation of his money factory all these years. Do you think the TMB is in the pocket of "makers of standard chemotherapy drugs"? If so, why don't they provide the TMB with some competent lawyers?

On the other hand, Burzynski has long been a darling of the penny-stock pump 'n' dump crowd. Who's paying Merola's bills? It is well known who pays Burzynski's. "All about money," indeed. The mansion itself is a third of an acre.

For Dr. B, it is all about the money - always has been. He's set up his clinic so that all the profits are funneled to him by "charging" the clinic just enough for rent and expenses (and licensing his process) to make it look like the clinic either operates at a net-neutral or a small loss (for tax purposes).

All you need to do is read the clinic's SEC filings to see exactly how Dr. B operates....

All you need to do is read the clinic’s SEC filings to see exactly how Dr. B operates….

These are rather opaque unless one has an accountant to hand.

BTW, the Richert case against Burzynski and BC/BS is going to trial. The latter party is probably fine; Count Scamislaw, not so much. Does anyone know whether Quinlan was settled after the nonsuiting?

I just noticed this following disclaimer was recently added to Merola's film website. I wonder if there was any legal impetus, in light of all the recent events surrounding Burzynski, that prompted Merola to add this paragraph:

Disclaimer: This documentary film series is not affiliated with Dr. Stanislaw Burzynski MD, PhD, The Burzynski Clinic, or the Burzynski Research Institute, Inc. It is an independent film series produced by Eric Merola, and should not be misunderstood as an advertisement for the Burzynski Clinic. This film series and this web site is not intended to replace professional medical advice.

Not to be misunderstood as an advertisement?!! I almost spit my tea all over my keyboard and screen!

I think while we are in the subject of discussing "scams", it's time to look at all those so-called "successes" in conventional treatment of most kinds of cancer. The fact is that virtually no real progress has been made in conventional treatment of most cancers in the past several decades, despite billions of dollars going to "research", and billions that have gone to pay for chemotherapy, surgery, radiation, all to put people through misery for the last months of their lives. Yes, there are a few cancers that can be successfully treated today -- non-hodgkins lymphoma, prostate, and arguably (though I believe questionably), breast cancer. But for most others, drastic and very expensive treatment yields rather poor responses. E.g. why is chemotherapy still considered "the best" way to treat pancreatic cancer, when the best outcome seems to be a 5% survival. That isn't an answer. It is reminiscent of a radio program I heard as a child, discussing bacteria transmitted in surgery: "The surgery was a success, but the patient died". It still rings in my ears today, but now I hear "The chemotherapy and radiation were a success, but the patient died"

It is enough to make me believe (like so many others), that many, if not most of those involved in providing conventional cancer treatments don't want to find out that there is, in fact, a better way of doing things. Maybe not simpler (as so many alternative scams are), but better. It's just going to take "thinking outside the box". And while we are at it, why isn't anyone looking at what is causing what appears to be an increase in some kinds of cancer in recent years? -- Particularly what appears to be an increase in "untreatable" cancers? Perhaps if we could figure that out, we could do more real prevention.

In short -- I believe there has to be a better way. Perhaps if there were not so much animosity towards considering any kind of "alternative" and all that energy going to suppress them, it might be possible to find some approaches that would really be effective. There are answers out there, but we don't seem to be capable of opening our minds to find them.

There is no "animosity" towards "other ways." There is just skepticism and a requirement for actual data that demonstrate that these "other ways" have promise, something that is utterly lacking for Burzynski. Instead, we get this:

http://scienceblogs.com/insolence/2014/02/12/stanislaw-burzynski-and-th…

As the other "credulous" reporter referenced here, I just want to reinforce that the story I wrote was one of several written about a family taking desperate measures to save a child with cancer who had run out of "conventional" treatment options. They were well aware of the quackery charges against Dr. Burzynski, yet were willing to take a calculated risk. It is not my duty as a journalist to tell them they are making a mistake - although I did discuss with the grandfather what I had learned about Burzynski in researching it on background for the story. He knew it all, and had visited the clinic himself. For the poster of this blog to persist in calling me a "credulous" reporter in the context of this blog reinforces to me that he is unable to comprehend that sometimes the elements of a story are not what the story is actually about. I cannot and will not investigate Dr. Burzynski – it was out of my realm of expertise and resources, and has already been done by other investigative health and regional reporters; I will report why a New Hampshire family is feeling so desperate that they are willing to petition the FDA for an unproven and controversial treatment. There was nothing about what I wrote that added credulity to Dr. Burzynski or his method.

How can a choice be both desperate and calculated? I think desperate is more accurate. Further, conventional treatment includes supportive and palliative care. No, conventional treatments had not been exhausted. By no means is it a controversial treatment either. It is an ineffective treatment, and if, god forbid, you need to spend 10 minutes "investigating" Burzynski to realize that, it will be time well spent. Outside of your expertise? That's why reporters call experts. And maybe you don't have the resources to make a phone call, but then again, newsroom budgets are being squeezed, eh? You were sitting on a much more important, revealing, and sinister story and completely missed it. And you gave B free press. And how can you run things like "How you can help" and think that you aren't adding credibility to Burzynski? Is it helping to send someone into a quack's clutches? Take this:

"McKenzie's grandfather, Frank LaFountain, said the FDA has proof the controversial treatment, available through a clinic in Texas, has a 33 percent cure rate, versus that of conventional cancer treatment, which has a 0 percent cure rate for the kind of cancer McKenzie is up against."

Aaaand did you check this? A claim about a new treatment about an incurable cancer needs to be checked. Or did you just allow unsubstantiated conspiratorial bullshit to constitute the bulk of your article? Oh, wait, you just passed it on. How can you not be painted justly as a quack's dupe when you say:

"Watch the YouTube video, uploaded here, in which McKenzie and her grandfather tell their story. Then, go to change.org and sign the petition.

"Then, pass it on."

No, not misleading at all. I mean, other than your readers and, apparently, yourself.

I know. I'm shocked that Ms. Robidoux would think that readers who know something about Stanislaw Burzynski and antineoplastons should reasonably interpret her story as anything more than an advertorial for Burzynski, given how sympathetic it was for the family and how the "controversy" over his therapy was treated in such an obligatorily rote fashion, a mere afterthought tacked on because of the required "tell both sides" narrative in journalism. Sorry, I don't buy it. Ms. Robidoux basically transcribed Burzynski propaganda without checking any of it and blithely whisked over the issues with Burzynski as a "controversy" that the parents are "aware of." I mean, seriously. Her article was entitled "Saving McKenzie Lowe: How you can help," fed cryin' out loud.

I stand by my characterization of Ms. Robidoux as a credulous reporter.

@Orac - agreed. This wasn't even about offering a "balanced" view....which we know there are times when there is no balance (because one side is incredibly wrong, wrong, wrong), but in this case, we have a reporter who didn't even attempt to portray the real facts or present the idea that this isn't a "controversial" treatment, so much as it is a treatment that never been shown to be effective, ever!

Speaking as a former journalist, I want to defend Ms. Robidoux against the allegation that she's a credulous reporter.

Robidoux: " I cannot and will not investigate Dr. Burzynski – it was out of my realm of expertise and resources, and has already been done by other investigative health and regional reporters; I will report why a New Hampshire family is feeling so desperate that they are willing to petition the FDA for an unproven and controversial treatment."

There's nothing in her comments or story to prove that she's credulous and willing to take Burzynski entirely at face value. It is entirely possible that Ms. Robidoux is just lazy and irresponsible, which is a different matter entirely. It takes a certain amount of effort to do justice to a story, and perhaps Ms. Robidoux just didn't care to do her job properly.

Either way, of course, her story is a disservice to her readers.

"There was nothing about what I wrote that added credulity to Dr. Burzynski or his method."

If you don't know the difference between credulity and credibility, you shouldn't be a reporter.

Speaking from more than 20 years' experience as a reporter, editor and journalism enabler, I can say with no heistation that Robidoux's self-serving prattle simply reinforces the massive journalism fail she and her editors committed. She sacrifices the family's financial resources for the sake of more eyeballs and click-throughs. Pathetic.

The charge that Ms Robidoux was credulous seems entirely fair to me. Her article showed no sign of wanting to get at the truth: she merely took Burzynski's PR at face value.

It's a shame that she seems to want to try to defend her mistake, rather than learning from it.

I think it makes it even worse that Ms. Robidoux acknowledges that she knew that Burzynski has been exposed as a charlatan and snake oil salesman and yet still wrote her credulous article, even encouraging people to sign that misleading petition and committed all the other journalistic sins that have been enumerated.

When the many issues in her article were brought to her attention, the only change (if I remember correctly) was to add a hyperlink to the USA Today article.over the existing text.

I do give her credit for actually responding to the criticism, however.

This is "churnalism", recycling press releases under the guise of reportage. It happens everywhere, but it is particularly dangerous in the health arena (and of course this is how the Daily Mail gets most of its health content).

It's not just lazy reporting, it's dangerously irresponsible and a dereliction of duty. If you're going to shill for a quack at least be aware that's what you are doing!

Stanislaw Burzynski and the cynical use of cancer patients as shields and weapons against the FDA

oracknows — Wed, 22 Jan 2014 06:00:50 +0000

Stanislaw Burzynski and the cynical use of cancer patients as shields and weapons against the FDA

I realize that I just wrote about infamous cancer doctor Stanislaw Burzynski yesterday. (Note how I refuse to call him an "oncologist," mainly because he isn't one, having never completed an oncology fellowship—or even an internal medicine residency, the usual prerequisite to do an oncology fellowship.) However, there's a bit more that I wanted to touch on before moving on to other topics. What brought this on was a Google Alert that appeared in my in box yesterday relevant to yesterday's post. You might recall that yesterday I mentioned a campaign by the Alliance for Natural Health USA (ANH-USA) to encourage people to write to their legislators to put pressure on the FDA to allow Stanislaw Burzynski to treat patients with inoperable brain cancers on compassionate use protocols and, of course, to attack Burzynski's critics, in particular Liz Szabo and the newspaper that published her expose of Burzynski, USA TODAY. A key aspect of this campaign by the ANH-USA was a claim that somehow the FDA had violated the privacy of one of Burzynski's patients by providing to Szabo some of his medical records included in records of its investigation. This led ANH-USA to proclaim:

The FDA violated Burzynski patients’ privacy. “A lot of our patients were obviously very irked about the article, and called the USA Today team,” a Burzynski staff member told us. “The parents of one young patient called a USA Today reporter, who then sent the parents their own child’s confidential medical records—which the reporter had received from the FDA. The family frantically called us [the clinic], ‘I just got an email from USA Today, they sent me our son’s full medical records!’” The reporter had sent not only the son’s medical records, but those of other patients as well.

Don't bother clicking on the link. As I mentioned in yesterday's post, it's dead. At the time, I wondered why. Now, thanks to my Google Alert, I know. The ANH-USA actually admitted screwing up:

In our recent article “Dying Patients Denied Access to Dr. Burzynski’s Potentially Lifesaving Treatment,” we quoted a Burzynski clinic employee who stated that the FDA shared private medical records with a USA Today reporter. We have since learned that this was not accurate.

USA Today’s reporter had previously stated, “I read about N’s case in a document that Dr. Burzynski sent to the FDA, in response to its ongoing investigation.” This seemed to confirm the allegation that the FDA had given the reporter confidential patient information. However, in response to our article, the reporter now says, “Those patient records did not come from the FDA, so there was no privacy violation on their part.” The first statement appears to have been an attempt to protect the identity of the person who did provide the confidential patient information.

My guess is that, given its previous history, the ANH-USA must have found out a doozy of a—shall we say?—inconvenient fact to have not only removed its original attack on Liz Szabo and USA TODAY but also to have admitted that it had screwed up. Anyone want to bet that it was the Burzynski Clinic that sent those records in error? It wouldn't surprise me. Whatever the case, however those records got out of the Burzynski Clinic, this explains why the ANH-USA article is gone from its website. That might do it. Other ideas might come to your mind to explain this rather startling development.

Attacks from the ANH-USA on Szabo and Burzynski critics are understandable. That's it's MO, its raison d'être, if you will. It exists to promote "natural health" (whatever that means), and for whatever reason that toxic mass of chemically synthesized peptides known as antineoplastons, manufactured by brave maverick doctor Stanislaw Burzynski, has somehow become considered to be "natural healing," rather than what it really is, chemotherapy. Again, although it's puzzling that the ANH-USA would view chemotherapy like Burzynski's ANPs as "natural," it's not at all surprising that, once having made that determination, it would attack Burzynski critics or anyone exposing the truth about what Burzynski does. Again, the ANH-USA is ideologically committed to treatments like Burzynski's.

I can also understand why cancer patients and their families would rally around Burzynski, at least the ones who have come to believe in him. That's even easier to understand than why the ANH-USA would rally around him. These patients and families really and truly believe that Burzynski is the only one who can save them or their loved ones. Faced with the prospect of impending death, no price is too much to pay, and no countering information can be tolerated, because the alternative if Burzynski can't do what he claims to be able to do is too terrible to contemplate. This is why families like those of McKenzie Lowe, Refael Elisha Meir ben Devorah Cohen, and Eliza Cozad, for example, go to such lengths to raise money. Even after Szabo's expose, these patients's families believed. Burzynski is expensive, but who can put a price on the lives of their loved ones, even if there are critics and doubts? Before them there were many more, as I've documented over the last couple of years.

Szabo herself noticed this phenomenon. Indeed, there is now a two part story about her investigation of the Burzynski Clinic that is quite revealing, Q&A with Liz Szabo: Braving legal threats to investigate a medical folk hero and Q&A with Liz Szabo Part 2: Seeing the humanity in the harshest of critics. The first thing I couldn't help but notice is this statement by Szabo:

The first was Burzynski himself. I first wrote about Burzynski very briefly in a cover story about a new book on alternative medicine, which was, as our lawyer described it, a “longish book review.” As part of my routine reporting, I emailed Burzynski for a response to the book, which was not flattering to him.

I expected Burzynski to ignore me or decline the interview. Instead, I got an 8-page response from his attorneys, warning us of the dangers of writing about their client. That was a first. I’ve never in my life gotten a legal warning about a story before I’ve even written a word. It was a red flag. Also, it was hard to believe that his lawyer could really whip up a letter like this in 24 hours. It seemed more likely that the lawyer had it on file and was perhaps in the habit of sending legal warnings to journalists. That bugged me. Whenever someone works that hard to keep a story from being published, it’s a pretty good sign that you need to write it.

Ironically, Stanislaw Burzynski and his lawyer Richard Jaffe might very well have brought Szabo's investigation on themselves. If they had just ignored her or given a perfunctory or unenlightening response, her interest in the story might never have been piqued, and that devastating USA TODAY article might never have come to be. Worse, she discusses the families:

One couple wrote to say that they are still hoping to see Burzynski, and they’re actually petitioning the FDA to get his trials reopened. It was difficult to know what to say to them. They are undeterred by all the criticism.

She also notes that the people seeking out Burzynski and attacking her are, by and large, good people in bad situations. So even after the expose in USA TODAY, people still want to see Burzynski; they are still raising money; and, as I discussed yesterday, they're even resurrecting an old strategy that Burzynski used the last time his back was really up against the wall in the mid-1990s. The fundraising campaigns and campaigns to lobby Congress suck in more than just those directly involved with the families and patients, too. They suck in local businessmen, who, for example, donate proceeds from their pizza restaurant to funds set up by the family of a Burzynski patient, reminiscent of the sorts of fundraising efforts inspired by patients like Hannah Bradley, Laura Hymas, Amelia Saunders, and many others.

I've always wondered what the source of the power of purveyors of dubious cancer treatments is. Patients and families are the source of their power, yes, but that doesn't explain it all, because they are a relatively small number of people in the grand scheme of things. Their belief, however, is incredibly intense, and the intensity of their belief serves as the nidus of a community. That pizza shop owner in Nashua, NH believes he is doing great good by raising money for McKenzie Lowe's campaign and by gathering signatures on petitions to the FDA and lawmakers to grant compassionate use exemption for ANPs for these patients. U.S. Sen. Kelly Ayotte (R-NH) believes she is doing good for one of her constituents by writing a letter to the FDA asking the FDA Commissioner not to "stand in the way when no other treatment options are available for an already terminally ill child." The Jewish communities that have rallied around the plight of Raphael Elisha Meir ben Devorah Cohen to raise well over $100,000 and over 100,000 signatures on a We The People petition, enough signatures that the Obama administration will have to respond. The campaign has even gone international, with stories appearing in Israel and other Jewish communities around the world. Basically, what "brave maverick cancer doctors" like Burzynski do is to pervert the best instincts of humans, the desire to help a fellow human in distress and to build communities to do it. These communities spring up to help, and they end up becoming tools of the Burzynski advertising machine.

Aiding and abetting this is another good human trait, the desire to think the best of people, to respect others, to let them find their own way without interference. How this is used as a sword and shield, like the patients, against Burzynski critics is exemplified by a post by Randy Barnes, who argues that we should "respect" the parents of Elisha Cohen:

I am not a fan of the Burzynski Clinic, and I agree with many of the criticisms leveled at Stanislaw Burzynski and his treatments. But this is not about my opinion of the clinic. Raphael Elisha’s parents are the only ones with the right and responsibility to make the best decisions they can in a horrible situation that no one who has not faced the loss of a child can possibly understand. The Cohen family is fully aware of the controversy. They have read the articles on the clinic. However, they have also spoken to people who are convinced that Burzynski cured their cancer. As Raphael Elisha’s parents, they have decided to pursue this course of treatment if it is made available.

In the meantime, the family continues its frantic race against time as they search across the globe for other experimental medications that could be a fit for Raphael Elisha. And friends and supporters of the Cohens continue to pray, donate money, and sign the petition.

None of this, unfortunately, does Elisha any actual good with respect to his cancer. I realize that what I said can come across as harsh and that some families are likely to react very negatively to it, but it's true. The community that has sprung up around Elisha Cohen might provide emotional support and make the family feel good, but ANPs will not help Elisha. These petitions will not help Elisha survive his cancer. The same is true of all the other cancer patients whose families are petitioning the White House, their legislators, and the FDA in Stanislaw Burzynski's name. They will, however, help Stanislaw Burzynski in his battle against the FDA and the Texas Medical Board. Unwittingly, blinded by a noble desire not to cause the family any more pain than they are already enduring, people conflate "respecting the family's decision" with not telling them they're making a huge mistake, which, if they are successful, will result in their loved one undergoing a toxic therapy with no better chance of helping him than conventional treatment while, even worse, it will allow Stanislaw Burzynski to prey on cancer patients again. Desperate to help their loved ones, these families have become unwitting pawns in Burzynski's battle with the authorities, while all the well-meaning, good people who do things like hold fundraisers in their pizza parlors to help these families have also become pawns.

Again, I realize that's harsh, but that's what Burzynski counts on: No matter how much his critics try to sugar coat their criticisms, they will be accused of "attacking patients." Indeed, that's a huge part of the entire message of the section on "The Skeptics" in Eric Merola's second movie about Burzynski: To paint them as heartless bastards cackling over the misfortune of cancer patients seeking out Burzynski's concoction and hoping that they die. Nothing could be further from the truth. My way of respecting the families of Burzynski patients is to assume that they will be able to handle coming across science-based analyses of Burzynski's claims and actions in their Google searches and, yes, evenanalyses of the testimonials of patients who believe they've been cured by Burzynski to show that there's no convincing evidence that Burzynski has been responsible for saving a single cancer patient. I realize that it's probably too late for families like the ones described here. But if I prevent even a single new family from falling under Burzynski's spell or even a single legislator from harassing the FDA on Burzynski's behalf, I will consider my efforts to have been worth it. The real petitions and investigations that should be going on are asking our representatives and Kathleen Sebelius, Secretary of Health and Human Services, the Department in which the FDA is housed in the federal government, why the FDA has let Burzynski get away with his abuse of cancer patients and clinical trials for 37 years.

oracknows Wed, 01/22/2014 - 01:00

Categories

Medicine

Frequently, victims of a con don't want to admit that they've been conned. Burzynski's patients, and the next-of-kin of his patients who have died, are in this category. I've even seen this happen in cases where the only loss was pride: a guy I knew in college once offered several people a liquid which he identified as a traditional Taiwanese beverage (it was actually soy sauce), and his earlier victims helped him to draw in his later victims. I can see how people who have spent thousands of dollars on Burzynski's treatments might double down on that position.

It's also quite revealing that Szabo's routine request for comment was met with an eight-page legal threat. Burzynski and his lawyer must have assumed that Szabo would back off, as others had before. But Szabo is an all-too-rare creature: a real journalist in a position to commit acts of real journalism. The last thing you want to do when such a person calls is act like you have something to hide.

What I frequently try to point out to people bringing up Elisha Cohen's case is that the FDA has not actually forbidden the use of neoplastons. The FDA has only forbidden the use of Burzynski. Surely if there were something to the whole neoplaston idea, you'd find another doctor willing to treat you with them.

You can't? Hmm. Maybe that should tell you something.

And it isn't like Burnzynski's patents are either expired or just about to expire - at this point, if anyone else was interested, they should certainly be either doing so or getting prepared to do so....I agree, that fact that no one else in the world seems to want to touch these things should tell you something.

A clarification: Antineoplastons represent an unapproved drug. Consequently, they cannot be used in routine clinical practice. They can only be used in the context of an approved clinical trial. Aside from Hidaeka Tsuda in Japan, there are no other investigators besides Burzynski running clinical trials with antineoplastons of whom I'm aware. So shutting Burzynski down basically means no more antineoplastons, at least in the U.S., because, as you point out, no reputable researcher that I'm aware of is interested in carrying out clinical trial research using them. This has been true since the last time Burzynski collaborated with the Mayo Clinic and others to carry out clinical trials. The clinical trials were resoundingly negative, and Burzynski was such a pain to work with that no one else wanted to work with him.

Wonder if Randy Barnes would accept his own argument as a valid defense of parents choosing other unproven alt med treatments, for indications other than cancer, which are also known to cause serious side effects and for which there's no evidence of efficacy?

Consider autism--does he support a parent's right to choose chemical castration (a la the Geirs)?

How about bleach enemas?

"The autistic chilld's parents are the only ones with the right and responsibility to make the best decisions they can in a horrible situation that no one who is not caring for an autistic child can possibly understand. The family is fully aware of the controversy and have read the articles on bleach enemas using industrial grade bleaches like Miracle Mineral Solution. However, they have also spoken to people who are convinced that bleach enemas recovered their autistic children."

Or is this argument somehow only supposed to be apply when we're talking about cancer and the use of ANP's?

"which, if they are successful, will result in their loved one undergoing a toxic therapy with no better chance of helping him than conventional treatment while, even worse, it will allow Stanislaw Burzynski to prey on cancer patients again"

Is this just poor phrasing or am I misunderstanding? I read this as meaning ANP works as well as conventional treatment but no better? Whereas I was under the impression that there is no scientific evidence that ANPs work at all.

Please excuse my ignorance, but I, as a layperson, would never think to call someone an oncologist who didn't even complete the requisite training? Am I at risk of consulting a doctor who says they are, say, an orthopedic surgeon who has actually never touched a scalpel, or does this tend to only happen in the Land of Woo?

You have me a bit alarmed as a patient -granted, I usually try to know a bit about the doctor I am seeing before "hiring" them, but though I have read repeatedly "Burzynski is not an oncologist," it never occurred to me until today that there might be other MD's out there playing the same word games.

@Chuff: There are still many cases of cancer which are beyond the reach of conventional medicine. The best that can be done in such cases is palliative care, to make the patient's remaining time as painless as possible. This is one reason why Burzynski is able to operate as he currently does: many of these patients, and their families, aren't willing to take "no" for an answer to the question of whether they can be saved. Denial ain't just a river in Africa. So when someone like Burzynski answers that question with "Yes, but it will cost you …", many people will jump at the chance, notwithstanding the alarm bells that should be going off.

Is this just poor phrasing or am I misunderstanding? I read this as meaning ANP works as well as conventional treatment but no better?

That's what you read into it. All it means is that it's possible that ANPs might have some minimal antitumor activity but that we know it's not, as Burzynski says, as as good as conventional therapy (which is quite crappy for some of these tumors).

@Mrs Woo: It depends on jurisdiction, but in most US states, all you need is an MD (or equivalent degree, as specified by state law--unfortunately, in some states that means NDs and ODs) and a license to practice medicine in that state. Some states require a board certification of doctors claiming a specialty, but others do not. I don't know specifically about Texas law, but based on what I know of that state, I would expect them to be less strict than some.

"That’s what you read into it. All it means is that it’s possible that ANPs might have some minimal antitumor activity but that we know it’s not, as Burzynski says, as as good as conventional therapy (which is quite crappy for some of these tumors)."

Ahhh. Thanks, that explains it.

@Eric, I fully agree. I feel that if he genuinely believed ANPs worked there would have been a flood of positive trials by now. Either that or there is some serious self-delusion going on.

There's limited possibilities re: Burzynki believing ANP's work, given that he's been giving them to patients for more than 3 decades under the legal fiction of conducting Phase II clinical trials.

One, the data shows that they aren't effective but he's withholding publication in order to continue to run a lucrative practice providing desperate patients treatment he knows doesn't work. In which case he's the worst kind of conman.

Or the data show ANP's do work, but he's withholding publication in order to maintain a very lucrative monopoly on a cure for cancer, preventing it from being adopted as standard of care and denying the millions of cancer patients worldwide who can't raise enough money to travel to texas and be enrolled at his clinic access to a cure for the cancer that will kill them.

In which case he's worse than a conman--he's a monster.

I have decided to look on the “bright side” of this: Most people given the horrible news of a terminal cancer do NOT seek SB’s bogus treatment. We need to tell a few of their stories--how they coped, how the medical establishment treated them (medically and otherwise).

Good point, Dorothy. Quackery propers from the failure of cancer medicine, because investments on treatment are based on drug company benefits, rather than on changing strategies.
http://www.youtube.com/watch?v=FBLnL4XA6fc

Forgive me if this has been covered elsewhere, but perhaps a regular wouldn't mind explaining to a fellow minion what the supposed mechanism of ANP therapy even is? It seems like Burzynski treats (*ahem*) a lot of brain tumors, but can ANPs even cross the blood brain barrier?

@JGC: I think we can rule out your second option. If there were anything to ANPs as therapy, Burzynski would find it more profitable overall to run his trials by the book, and thereby avoid the scrutiny (and associated legal fees) he's getting from the FDA and the Texas Medical Board. Or alternatively, his legal fees would be an investment in getting a lucrative contract to manufacture ANPs and distribute them to doctors performing those trials--his profit per patient would be less, but he'd make it up on volume.

Also, "conman" and "monster" are not mutually exclusive options.

@Dorothy: I like your idea. Certainly, many terminal cancer patients accept their prognosis. It's likely that others look into the alleged treatments Burzynski and others offer and conclude that they can't (or are unlikely to, or are not worth the price to) deliver on their promises.

IMHO, the 'accidental' release of records blamed on the FDA sounds like a defense/delay tactic by Stanislaw Burzynski. As long as everyone is talking about the release of records they aren't talking about the actual treatments and the ethics of offering up expensive and profitable false hope to cancer patients. Odds are the fall guy within the Burzynski staff has already been selected and paid off. After some psychodrama to allow the organization to express how much they love their dedicated staff and how sad they are having to let them go the selected person will finally admit that hey did the deed and reflexively blamed the always bullying FDA. It will all be stage managed for effect and be assured that the sacrificial lamb will won't suffer much and can expect to get a job within one of the larger anti-vaccine organizations after an appropriate interval so that few notice.

It is nearly impossible to be too cynical.

The ....chilld’s parents are the only ones with the right and responsibility to make the best decisions they can

Except in cases where they are wholly unqualified to do so.

Burzynski first suggested that cancer is 'a disease of cellular information processing and antineoplastons seem to 'correct the program inside the cell' changing a cancerous cell back to a normal cell. (Then again, he also claims that they aren't toxic and that they aren't chemotherapy.)

He's since moved on to suggest tmultiple other possible mechanisms--that they work by inhibiting oncogenes, by suppressing protein synthesis, and by activating tumor suppressor genes.

The latter proposed mechanisms are presumably based on the fact that antineoplastons are metabolites of a known drug, sodium phenylbutyrate, a histone deacetylase inhibitor which has been seen to inhibit protein synthesis in cultured cells. In prostate cancer cell lines--and again in culture--PB has been seen to inhibit VEGF production and to induce apoptosis.

This would seem to me to be a more plausible mechanism by which ANP's might act, if cancer cells were more sensitive to ANP's than normal cells and if a therapeutic circulating level could be achieved with an acceptable side effect profile. That doesn't appear to be the case, however: a number of clinical trials looking at sodium phenylbutyrate as a cancer treatment have been conducted by researchers other than Burzynski (including at least one in glioma patients, Stan's berad and butter) but show no evidence it holds promise as a treatment for advanced cancers.

the ANH-USA is ideologically committed to treatments like Burzynski’s.

Indeed, part of their brief is to defend homeopathy.

Burzynski staff member: a USA Today reporter ... sent the parents their own child’s confidential medical records

Central to the staff member's outrage is the fact that the parents gained access to their child's records. Presumably those records were Burzynski IP.

For the parents, this was evidently the first revelation that their child died from clinical malpractice. What had Burzynski told them previously?

Szabo:

“I read about N’s case in a document that Dr. Burzynski sent to the FDA, in response to its ongoing investigation.”

ANH-USA:

This seemed to confirm the allegation that the FDA had given the reporter confidential patient information. [...] The first statement appears to have been an attempt to protect the identity of the person who did provide the confidential patient information.

This bizarre wordtwisty misreading -- to explain why they accepted the Burzynski defamation of Szabo & the FDA without bothering to check with either -- suggests that they are uncomprehending idiots, or Burzynski sockpuppets. Or of course they could be both.

Dorothy, a resource like the one you suggest does exist: just google "The OTHER Burzynski Patient Group." It popped up on the autocomplete by the time I got to the "B" in Burzynski.

I'll be writing my congresscritters this weekend.

JGC@#12:

There is a third option, which is of course the 'true believer' option. He's convinced that ANPs work. ANPs don't work in other places because interfering and skeptical doctors prevent patients from actually following the protocols. (See the previously-mentioned third-party test that was called off due to the side effects.) If you look at all the evidence through properly rose-coloured glasses, every single failure gets written off as somebody else's mistake, because of course the ANPs work, why would he have spent all his life pushing this if they don't work?

There is no bright side to the Burzynski Clinic. That some people don't end up there is cold comfort. All we can do is make sure it does NOT happen again. And you can help. And you should if you're mad about what's been going on. You have a chance of ending something as ethical, in my opinion, as the Tuskegee Experiment, which has gone on just as long, included 8X as many people, and went on while the FDA was giving him horrible site review after horrible site review and letting it continue. NOW STOP KVETCHING--STEP UP AND HELP US STOP IT! thehoustoncancerquack.com

I'm a longtime reader but only chiming in now because this is getting into one of my areas of expertise: administrative law. I have a lot of hope that this case will stick, if only because the current FDA agency head and staff have shown that they are focused on science over politics. This is the agency that approved the Plan B availability for teenagers without a prescription (a decision which was overturned by the head of the HHS, but the HHS wouldn't have any power over the due process hearing that would be involved in this case). If anything, I don't think it would be political pressure stopping them but concerns about the best use of funds. There is no question that this guy is going to appeal a negative decision, and the agency might wonder if the time and money spent on 5 years of appeals might be better spent on other things. That should be what anyone says when contacting a representative about the issue; that this is the type of issue that we want tax money being spent on because it is costing lives and giving people false hope.

I just can't believe anyone would still consider Burz after learning he also pitched his snake oil ANPs as a cure for HIV as well.

Oh - and he also invented and sells 'miracle anti-aging cream' and anti-cancer toothpaste (!).

Sickeningly evil, scum of the Earth charlatan. All he cares about is getting rich. No scam too low for our Stan.

Let's hope more evidence of his swindling and lies comes out soon. He deserves to die in jail.

Don't forget that (as reported on this blog), antineoplaston therapy has also been proposed as a preventative against aging (Stan authored a paper on this some years ago, and an antineoplaston-containing supplement has been touted for use against aging and Alzheimer's):

http://www.zenbuffy.com/2012/03/its-burzynski-jim-but-not-as-we-know-it/

In my experience, it is highly characteristic of snake oil to be marketed as effective against a wide range of disparate conditions.

Burzynski does look rather old for someone who possesses the cure for aging.

antineoplaston therapy has also been proposed as a preventative against aging (Stan authored a paper on this some years ago

At the same time, he is careful to market his anti-aging products under the Aminocare label, to keep them separate from his main operation, so he is presumably aware that it is not a good look to have too many fingers in the alt-health care. But at the same time, the thought of a pool of money out there for anti-aging products -- and none of it going to him -- is too strong to resist.

The Aminocare side-line is the strongest evidence against the "sincerely deluded" interpretation of Burzynski's behaviour.

As 2013 draws to a close in the skeptical world...

oracknows — Tue, 31 Dec 2013 10:30:18 +0000

As 2013 draws to a close in the skeptical world...

As I write this, 2013 is drawing to a close, with only a little more than 12 hours to go before the crowds now gathering at Times Square and elsewhere ring in 2014. For some of you, 2014 has already arrived or will arrive many hours before it does for me. I'm not normally one to do much navel gazing, but 2013 has been a mixed year. As far as this blog goes, for instance, readership is up, with over 3.5 million page views for the year, although that's still a little below the blog's height before the whole "Pepsigate" thing. (It's really hard to believe that was almost three and a half years ago!) It's sad to think it's taken so long for traffic to get back up to where it was before that debacle,

While it's true that the usual topics, such as antivaccine pseudoscience, various forms of "complementary and alternative medicine" (CAM), and the science and clinical practice of oncology, dominated in 2013, it's clear that 2013 was also the year of one person, at least on this blog. That person, of course, is Stanislaw Burzynski, the erstwhile Houston cancer doctor with board certification—or even training!—in oncology and no board certification even in internal medicine. (Board eligibility or certification in internal medicine is a prerequisite for a medical oncology fellowship.) This interest, of course, is a spillover from 2012 and even late 2011, when I first took a major interest in Burzynski and his magical urine-derived (now chemically synthesized) cure for deadly cancers, antineoplastons. Indeed, as 2013 dawned, I had received an invitation from Eric Merola himself, Stanislaw Burzynski's very own Leni Riefenstahl (but without the talent), to appear on camera in the sequel to the first propaganda film about Burzynski, released in 2010 but not taking the quackosphere by storm until 2011. I politely declined.

Still, trying to refute the misinformation being spread about Burzynski by his sycophants, toadies, and lackeys really hit full gear in 2013 with the release of Merola's second movie about Burzynski, which, as I predicted before its release, was going to be just like the first one, only Burzynskier. And so it was, except for one thing: An all out assault on "skeptics" (i.e., people like me) who had been critical of Burzynski's science (or, more appropriately, lack of science), who are portrayed in Merola's second Burzynski movie as evil meanies who cackle evilly as they terrorize cancer patients online and delight in crushing their hope. No, I'm not exaggerating either. Bob Blaskiewicz and I had been collaborating in writing about the pseudoscience promoted by Burzynski, how bogus his clinical trials were, and how he has not published the complete results of any of his phase II trials in the peer-reviewed scientific literature. All he has are anecdotes that fall apart when examined closely. Much of our work is summarized in these talks given by Bob and a certain "friend" of this blog at The Amazing Meeting in July:

In any case, thanks to the efforts of people like Bob, a whole bevy of other skeptical bloggers (and Twitterers), and (at the risk of being insufficiently modest) myself, Burzynski finally found himself getting mainstream notice—and not in a good way. I like to think that I had a small part in this change in reporting, as one of the several skeptical bloggers who kept writing about Burzynski throughout 2012 and 2013. In any case, where before he could routinely count on credulous or careless journalists reporting his party line and not mentioning all the unethical and questionable things he did when patients and families, convinced that Burzynski was the only person who could save them or their loved ones raised prodigious sums of cash to go to Houston, in 2013 there was more skeptical coverage. There were even two large stories, one in the UK by the venerable BBC newsmagazine Panorama, and one here in the States in USA TODAY, documenting the Burzynski story. Through it all, the FDA had investigated Burzynski beginning in January and closed the year by issuing its reports finding horrible lapses in clinical trial conduct, such as not reporting severe adverse reactions to his antineoplaston therapy and inappropriately using the expedited approval process to allow his IRB to rubberstamp single patient protocol exemptions so that individual patients could receive antineoplastons. He even gave the FDA medical records of a patient who died that did not match the contents of the medical records the FDA examined at his office. (Oops!) Yes, different sets of records were apparently maintained on a child with a terminal brain tumor whose life was cut even shorter because Burzynski’s treatment killed him.

Even so, there is more work to do. Even after the USA TODAY report was published in November, Burzynski managed nonetheless to present some very unimpressive results of his phase II trials at the Society of Neuro-Oncology Meeting in San Francisco. Meanwhile, his supporters, undeterred by facts and science, have developed a new tactic, which is to have the families of people with deadly brain cancers petition the FDA to allow them to receive antineoplastons under a compassionate use exemption. Such patients have included McKenzie Lowe, Liza Cozad, the wife of Sammy Hagar's drummer, and a young Jewish boy from the Houston area, Elisha Cohen, whose appeals have made it as far as Israel. Bob Blaskiewicz characterized this effort as exploiting the misery of a family, and, sadly, that's an appropriate characterization.

For our efforts, in 2013 Bob and I withstood a whole lot of ad hominem attacks and outright attempts at character assassination. Other skeptical bloggers also endured such attacks, but Eric Merola has referred to this blog as an "anti-Burzynski" blog, which it is not, given that Burzynski is only one of many topics this blog covers, and yours truly as a white supremacist who likes to eat puppies.

Still, however much hate is directed in my direction, Bob Blaskiewicz seems to be the most prominent target. I think I know why. While I write about how the science doesn't support Burzynski's treatments and how his knowledge of genomics that, according to him, guides his "personalized gene-targeted cancer therapy" is woefully deficient, Bob goes to the heart of the Burzynski empire. In The Other Burzynski Patient Group (TOBPG), devised as a counterweight to the Burzynski-approved Burzynski Patient Group (BPG), whose purpose is to publish anecdotes of Burzynski patients whom he's "cured," Bob publishes patient stories that illustrate just how ineffective antineoplastons are and how abused Burzynski patients are. Patients from the BPG are prominently featured in both of Eric Merola's "documentaries" cum propaganda films. As a cancer doctor, I sometimes find it difficult to read the accounts documented in TOBPG because they make me so angry. (They should make you angry too.) Add these accounts to my analyses of why the various anecdotes of surviving Burzynski patients are not powerful evidence that Burzynski cured them and are instead almost entirely consistent with patients either having indolent disease or having been cured by prior therapies, and the very foundation of the advertising drive that supports Burzynski is undermined.

I can't resist finishing out the year with two observations. First, the attacks on skeptics by Burzynski fans and shills continues apace. Just last night, Eric Merola was Tweeting stuff like this:

@BurzynskiMovie thanks 2 fans of Dr #burzynski 4 compiling this blog, must have been a lot of work 2 flw #sociopaths http://t.co/Euz4qNetzr

— Burzynski Movie (@BurzynskiMovie) December 31, 2013

If you go to the link, you'll see it's a blog post entitled BURZYNSKI SKEPTIC – INTRO TO THE SOCIOPATHIC RANTING OF BIGOTRY AND HATE BY THE ANTI-BURZYNSKI ASTROTURF / “SKEPTICS” (AKA “STATUS QUO CHAUVINISTS”). It's dated over six months old but mentions things that happened in the last week. I don't think that Eric Merola wrote it, but he did Tweet it (multiple times), making it fair game. It's also instructive to look at. Talk about a sociopathic rant! Basically, in this little rant, all opposition to Burzynski is due to pharma paying his opponents off; that is, when his opponents aren't like Hitler:

Notice PHIL HARRIS’ tweet. Racism is also common with the personalities the industry hires to carry out this dirty work. Sort of like hiring a professional hit man, these are not nice people. Imagine how deranged a human being must be to sit around all day getting paid to insult cancer patients on twitter and anyone practicing the concept of “thinking for yourself”. It’s right out of the policies of Mein Kampt.

Yes, I know I made a tongue-in-cheek reference comparing Eric Merola to Leni Riefenstahl "without the talent," but I couldn't think of a more famous and blatant propagandist to compare him to. Mea culpa. If someone can think of a better example, I'll use it.

In the meantime, apparently Bob Blaskiewicz is a Nazi, too:

Bob Blaskiewicz bragging just before he and his paid wanna-be Nazi cronies apparently hacked the Burzynski Clinic webpage.

No evidence is presented to back up this charge, of course. That doesn't stop the person who created the blog from continuing:

Robert “Bob” Blaskiewicz is an unbridled sociopath who sadly teaches English to children (if their parents only knew) - which is hilarious that he claims to teach “science” (lying pathologically is a part of the package of a sociopath like Bob)- he spends all day, every day, 7 days a week, nearly 24 hours a day following internet alerts to fight anyone online who finds out about Dr. Burzynski, a Burzynski patient, or anyone that dares talk about stepping outside of the status quo in regards to trying to save their own life (think Holocaust prisoner seeing an open door to the bunker, and Robert “Bob” Blaskiewicz is the guy that is secretly working for Hitler that says “oh no, you need to stay here, you will be fine if you stay here.” If you encounter this lunatic online, steer clear, unless you are ready to enter a realm of nonsensical, illogical, crazy neo-nazi style fireworks of fear, hate and unbridled bigotry.

Robert “Bob” Blaskiewicz is also the lunatic behind the cancer death list called “the other burzynski patient group” – He’s a very unstable and sick person.

Sadly, in comparison, I only get a mention as being the "highest paid" anti-Burzynski blogger of all, who "unleashes a fury of paid bigotry and hate unmatched by the late Adolf Hitler." Would that it were true that I actually got paid to blog about Burzynski, other than the small amount I make for blogging in general, which I would make whether I blogged about Burzynski or not! It's at least enough to keep me in high speed Internet service and cable, anyway, and that's only because of my aforementioned traffic last year.

In any case, all of us, apparently, including Bob Blaskiewicz, Peter Bowditch, Adam Jacobs, Paul Morgan (who is not even the same Paul Morgan described in the rant), Guy Chapman, Phil Harris, Rhys Morgan, and me, are on the verge of, well, let me just quote:

Just a small collection of the ranting tweets of hate from the Astroturf campaign known as “The Skeptics” towards scientific innovation that competes with the status quo, with a heavy focus on Dr. Stanislaw Burzynski and any of his patients. The Cancer Industry relies on such campaigns coupled with their Guerrilla-style internet vandalism tactics to highjack the search engines with slanted, biased, straw man, and often falsified information. You will notice they will never address a root argument. They rely only on bigoted and Chauvinist remarks, feeding on the fear in people – instead of rational and reasonable discussion. It is only a matter of time before they begin picketing the funerals of cancer patients.

Project much? What Burzynski and his minions (no, not those Minions, who are cute and cuddly, in marked contrast to the nastiness of Burzynski and many of his minions) fear is that perhaps finally the jig is up and Burzynski's gravy train ride is coming to an end. Thanks to skeptics influencing popular press, Burzynski can no longer count on credulous reporting or anecdotes that go uncorrected, and, until now, that has been his primary method of selling antineoplastons to the public.

If there was a "win" in the skeptical world in 2013, it has to be the unmasking of Stanislaw Burzynski to expose the utter lack of convincing science behind his antineoplaston therapy. Unfortunately, that is not enough. Burzynski is still practicing, and, although the FDA has issued warnings that make it incredibly unlikely that Burzynski will ever realize his apparent dream of seeing antineoplastons achieve FDA approval, he has pivoted to promoting his incompetently administered M.D. Anderson-wannabe "personalized gene-targeted cancer therapy." However, that does not appear to be as enticing to patients as antineoplastons for the simple reason that, if I were a cancer patient and wanted to have my tumor tested and treated according to new genomic analyses, I would go to M.D. Anderson Cancer Center, Memorial Sloan-Kettering Cancer Center, or any of the several NCI-designated comprehensive cancer centers that are doing this work. I would not go to the clinic of a "brave maverick doctor" who obviously has no clue what he is talking about with respect to what is now referred to as "precision medicine," much less how to do this sort of research and treatment right. In the meantime, we can't let ourselves get complacent. As Burzynski's latest attempt to influence Senators to pressure the FDA demonstrates, the patient anecdotes remain powerful tools to influence, and Burzynski is not afraid to use them cynically.

As 2013 draws to a close, for now Burzynski still stands, and he still practices. That is the unfinished work that lies ahead in 2014. In 2012, the Texas Medical Board failed to do what should have been done decades ago and strip Burzynski of his medical license. Maybe in 2014 it will finally succeed.

oracknows Tue, 12/31/2013 - 05:30

Categories

Social Sciences

Oh, Pepsi-gate, I forgot about that, during my quiet days. Memories...

And, a heartfelt congratulations on the one and only truly appropriate and eloquent way to go...there, in a blog. I snorted. The only other one I can think of that would even come close is Orwell's Ministry of Truth.

Thanks for the Science, amd for wading into cesspools not many of us are willing to. Happy New Year eveyone! May you all start 2014 only a little hung over.

You've done an admirable job this entire year of exquisitely dissecting all those sCAMs in your posts, Orac.

Happy New Year to you and to all your minions.

- lilady

I do not expect that either the quality or the relative frequency and absolute depth of woo-infested internet cesspools will see improvement in 2014- because..
.
Mikey will unveil his freshest tripe, Jake will continue his solipsistic "journalism", the sceptics will be "exposed" for all their worth courtesy of the "scholars in residence" @ PRN, TMs/ AoAers will dream up new ways to market both themselves and their incessant, mindless palaver, AJW hasn't yet been contained and altmedia mavens will continue to scoff at anything reasonable which SBM and reality itself has to offer.
In other words, 'business as usual'.

I extend my hopeful wishes for a happy and productive new year to our esteemed and gracious host ( with the most) and his many minions- as deeply entangled and financially compromised in the sordid web of pharma malfeasance as they are.

As for me- I have to prepare myself for the thankfully last outing of the holiday season which means that altho' I have assembled a totally b!tching outfit, I must work on my hair with a scaldingly hot steel implement for - alas! - I have hair that only a 20 year old, aspiring male hipster with a band would love and I am not a 20 year old, aspiring male hipster etc.

Have a happy new year, Orac!

As a year end gift (?) I present to you some blog fodder from your neighborhood:
http://oxfordhbot.com/our-staff/

Someone on the JREF forum had the place recommended to her mother by a relative. It looks horrifying, especially since there are no real medically trained staff. The "doctor" has a "doctoral degree in Autism and Medical Research from Wayne State University."

Oooh, and the "Dr. Sheffield" also does not have a medical degree:
http://www.hyperbaricmedicine.com/About_Us.htm

Chris, I clicked the link, and I love this opening sentence, The Powell’s were introduced to Hyperbaric Oxygen Therapy (HBOT) when researching for treatment options for their young daughter who developed viral encephalitis after a bout with chicken pox. Such a harmless diseases.

DW, do you really want to be a 20-year-old aspiring hipster?

@ AOP:

NO, NO, NO! (non-existent) g-d forbid !
I have HAIR that THEY would adore and display in pr photos.

@ DW Oh thank goodness.

If only Burzysnki could be stopped in 2014. Would be a celebration that would make any frustrations the year brought more than tolerable. There is nothing more frustrating than knowing desperate people are being taken advantage of, again and again.

Wishing a happy and prosperous New Year to Orac and all of his minions, as well as our evil galactic overlords.

Sadly, in comparison, I only get a mention as being the “highest paid” anti-Burzynski blogger of all, who “unleashes a fury of paid bigotry and hate unmatched by the late Adolf Hitler.”

Okay, but at least they got in the Hitler comparison. Xmas came after all!

Happy New Year to Orac and the Commentry.

I’ve read about this, but not in nearly enough detail to make an educated comment that’s on-target

Oh, look, ARCpoint comment spammer "Lindsey Leonard"/"Byron Berry"/"Drew Regan" is back. This time, abuse-at-cyberlynk.com has been notified.

^ "cyberlynk.comnet"

I'm with you on pretty much everything except the gravy-train ride. I think the Burzynski shills are not paid shills, they are not profiting directly from it (which is what this implies, though I am certain you didn't mean it).

They are a much more dangerous class of shill: the True Believer. And the more the cognitive dissonance piles up, the more vicious they are likely to get.

I recently had to go, reluctantly, to the police to stop someone who is in a lot of trouble with the "officers of the leur" as Clouseau would put it. I suspect that it may become necessary to exercise some form of restraint over a very small number of individuals in the Burzynski camp. Most of them are simply howling with the pain, but a couple of these characters come across as genuinely deranged.

We may have found the Dennis Markuze of sectarian medicine.

Keep up the good fight, O Blinking One.

Considering that Slate.com can usually be counted on as one of the voices of science reason, I was more than perturbed to open their site today and see a link to an article stating that "Exercise prevents, treats. or cures basically everything."

http://www.slate.com/articles/health_and_science/medical_examiner/2013/…

Phil Plait must be really cranky about that right now.

As a parting gift, AoA/ Dachel offer up a hint about new concerns ( * a la* the Canary Party):
"Tragically Hip, Chronically Sick..."

On that note, fearless leader and beloved fellow/ sister minions,
over and out.
DW

I’m with you on pretty much everything except the gravy-train ride. I think the Burzynski shills are not paid shills, they are not profiting directly from it (which is what this implies, though I am certain you didn’t mean it).

I never said they were. I meant Burzynski and his cronies at the Burzynski Clinic are aware that the gravy train could well be coming to the end.

I saw this story on the CBS morning program, and was surprised to see only the science side of the story -- no "balance..." Good for Lancaster General Hospital, BTW.

Nurse Fired For Refusing To Get Flu Shot
http://tinyurl.com/lqx3rjk

I can't understand the mentality of people, in a hospital setting, that refuse to take the necessary precautions to protect the charges in their care - especially in light of the overwhelming evidence that the flu shot is safe (if not entirely, incredibly effective - depending on the strain and year).

Thanks Orac for all the time, expertise and Insolence you put into RI. This blog has been something of a refuge over the past few years. Thanks to the regulars too for the different strengths that you bring to the discussions. Some of you put in a lot of time here and this lurker wants you to know that your efforts are very much appreciated. Here's to another great year at RI!

@ Carolyn: I already "on it". A number of the "RI Regulars" have already posted comments. :-)

Thanks and a very Happy New Year to Orac and all of his minions!! I read this blog everyday, I have learned so very much from you all and truly enjoy seeing the quacks and their followers/nutjobs taken down with facts that are backed up by science/proof and sources to find additional information, the added snark makes it very entertaining.
Please believe me when I tell you that what you all do does have an impact, alot of people are reading and learning but like me either do not comment or do so infrequently.
Please keep up the good work and always remember that what you do matters, it matters alot.
Cheers!!!

Great post. Your accuracy and persistence are appreciated.
One thing -- there appears to be an important word missing from the second sentence in the second paragraph. "no"

Happy and productive 2014 to you, Doc Orac.

Fred

Also, no need to post my previous comment. I mainly wanted to notify you of the missing no.

So what was the end result of Pepsigate? Trying to read with minions running around and screaming, I can't find what finally happened.

Thank you for all that you do Orac, you are a true hero to me, and keep the hope alive that we can one day be a science based society instead of woo/faith based. *raises glass of apple juice* Cheers

I don’t think that Eric Merola wrote it

It seems a bit too sloppy for that, although the same entity does repost, without attribution, the 2013 November 16 Burzynski movie newsletter (as does "Kelly the Kitchen Kop"), where one finds a succession of similar themes:

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

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

"When one applies that hate and bigotry to one's freedom to choose his own cancer therapy, along with an innovative scientist's supposed right to develop a new technology to fight a disease like cancer within a so called 'free society'—it is a recipe for disaster.

"In case we haven't noticed, we all live in a totalitarian capitalist society—from the USA to China (Take it from me, I was in Ghangzhou [sic] for 7 days last week myself). The very idea of a 'free market' is not one that exists in our society. If the market were free, then Antineoplastons would freely be on the market, instead of being resisted by the state. If the market were free, the banks would have freely failed back in 2008, instead of being protected by the state....

"What always comes with a good propaganda campaign, is a herded army willing to join its fight to preserve the totalitarian status quo by one's association of the group."

Merola of course has pointed at the W—pedia definition of "astroturf before" and also capitalizes "Cancer Industry."

There are a few graphics that aren't hosted locally, though. I'll take a look at the Gravatar MD5 hash later, but I have to do my Dead Pool picks.

Disagreeing with Burzynski is "Sort of like hiring a professional hit man"? Oh dear.

Scared Momma:

So what was the end result of Pepsigate? Trying to read with minions running around and screaming, I can’t find what finally happened.

Lots of bloggers left for places like FreeThoughtBlog, Scientopia, and elsewhere. Stuff was in shambles for a bit, and all has quieted down. And then National Geographic kind of took over ScienceBlogs.

As it turns out, there are now many fairly good science blogs now being sponsored by magazines. There is Wired, ScientificAmerican, another by National Geographic (Phenomena), and on and on.

Side note, referring back to an MSII post from 2012: W—pedia notes that Menudo's Draco Rosa dumped Count Scamula. Let's hope that his relapse is still amenable to curative treatment.

Awesome! Thank you Chris,!

Happy New Year, everyone!

Happy new year!

Orac, thanks for the hard work you put into taking on the quacks of this world. Hopefully we will see Burzynski loose his licence in the upcoming year.

Another long time lurker here that would like to say a huge thanks to Orac! RI is one of a handful of blogs I consistently read daily and is always my first stop every morning followed by SBM.

I also would like to thank all of the regular commenters, I learn so much from you all.

Happy New Year!

Happy New Year to Orac and his minions. I am yet another lurker chiming in to let you all know how much I appreciate the discussion here.

HOLIDAY GREETING BEGINS----------------------------------------

Shills and Minions,

Your concept of "important" never ceases to confound and baffle. From all the fol de rol that accompanies your seasonal transition you probably think that your planetary mechanics are a cause celebre across the Orion Arm. I can assure you that it is not. We have a lovely homeworld and 36 planets under various stages of subjugation. They all have their orbital eccentricities and vary from a stolid 0º of tilt (Eubrax VI) to a north pole-melting 42º on VX33863b, a dreadful little planet that doesn't even deserve a name (but is full of lovely gold, so we snatched it). Your obsession with "New Year's Rockin' Eve" isn't even really fully agreed upon by your fractious little clan of monkeys. What year is it really? 2014? 4713? 5774? To quote the great philosopher Ren Höek, it's all just stewmeat and handpuppets.

Really, Shills and Minions, pull yourselves together, sober up and get back to work. This planet isn't going to make itself safe for me and my scaly compatriots, you know. And you'd better hope we win out over the species competing for the domination of your little backwater. The Kthrakxx Hive and the Ventraxian Demipentium are numerous and resourceful. And besides, 7 out of 10 subjugated species agree, lizards are cruel and cold, but bugs are just plain creepy.

Lord Draconis Zeneca, VH7ihL
Forward Mavoon of the Great Fleet, Pharmaca Magna of Terra, Party Pooper of P-21 Prime

Glaxxon PharmaCOM Orbital
10110011100011110000111110000011111100000011111110000000

---------------------------------------------HOLIDAY GREETING ENDS

Someone please take poor "Fred" aside and explain about the whole "well-intentioned yet horribly misguided pedantry" thing. Don't worry Fred, we've all done it at least once, and I hear they're close to an effective treatment for SIWOTI syndrome. As for me, I'm still exhausted from excessive age-inappropriate dancing until 2:30 this morning. Happy New Year Insoleers!

How is it that the FDA (link in OP) doesn't say "failure to meet the standard of care". Surely having proper documentation of treatments and procedures for your patients and following proper ethical guidelines has a lot to do with providing care that meets standards?

On a somewhat related note: my wish for this year is to keep up with all the good science blogging (and comments!) but I know that's a pipe dream. But my thanks go to you Orac and to the regulars here. My dad recently found out he had cancer, and I am extremely grateful for all the SBM posts that geared me towards being rational about this whole horrid situation. You guys have educated me.

Thank you.

@ Hinterlander:
@ LurkeyLoo:
@ Lacy:
@ C.C.:

Heavens, four lurkers step forth nearly at the same time- or is it space? An auspicious start to the new year!

Slogging through the rancid malarial swamps of the metaphorical biofilm that is woo is a dirty job- but someone has to do it. So I, being called to this vocation, proceed. And hearing from you makes that misery actually tolerable.

@ flip:

Altho' I'm glad to hear you I'm sorry to hear your news.

Honestly, I used to think that alt med was an idiot tax. Not anymore. It's exploitative, predatory, and unforgivable.

@flip

How is it that the FDA (link in OP) doesn’t say “failure to meet the standard of care”. Surely having proper documentation of treatments and procedures for your patients and following proper ethical guidelines has a lot to do with providing care that meets standards?

Easy. The FDA doesn't regulate medical practice. That's the job of state medical boards.

I'm realizing my irony meter is woefully inadequate. Any recommendations for an upgrade? The thing keeps overloading and spitting sparks every time I load RI and many other websites as well. A model with SarcasmBoost and a Fur'n'Fangs adapter would be a plus but not necessary (it's amazing the things you can mod with four sets of claws).

Bigotry, you keep using that word, etc. Ai yi yi. (Somewhat o/t, but I just finished Lawrence Wright's Going Clear earlier today. There seems to be this theme of co-opting the language of social justice with these groups selling false hope, whether it's the Church of Scientology or the Burzynski Clinic.)

You'll note that the Bursinski camp does what every charlatan does, and try to sling mud at the people accusing them of being hucksters. Oh, and there are still people who believe the line of bullshit spewed by Kevin Trudeau too. Hard to understand it, but there are. So B's followers will probably continue to sing his praises, even after -- can we dare hope? -- put out of business by the FDA.

Actually, I think Fred's correction is important - I don't find every error worth pointing out, but this one entirely reversed the meaning of most of the sentence.

If I hadn't been a good reader, and the sentence complex enough that the secondary clause made me go "wait, that doesn't fit" then I would have walked away thinking that Burzynski actually has qualifications for patient care that he lacks.

Thanks for the informed comentary Orac, I mostly lurk but I do appreciate that your efforts might save a few reasonable people some anguish. Preying on the desperate and doomed is about as despicable as you can get but it seems to be both commonplace and widely accepted.

The fight will continue forever because greed appears to be an innately human trait, at least in some individuals. What a sad thing, that with all our progress we still carry the baggage of primitive and profoundly immoral capacities and have to stuggle with them, as if there was no choice involved.

Some times is is necessary to peel back the facade and see clearly just how putrid and decayed the substrate of our flawed society really is. As a surgeon, you do an excellent job of that and I have nothing but admiration for you doing so.

Fare forward.