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Burzynski Research Institute (PK)

Burzynski Research Institute (PK) (BZYR)

0.0405
0.00
(0.00%)
Closed July 20 4:00PM

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Key stats and details

Current Price
0.0405
Bid
0.0311
Ask
0.043
Volume
-
0.00 Day's Range 0.00
0.013 52 Week Range 0.085
Market Cap
Previous Close
0.0405
Open
-
Last Trade
Last Trade Time
Financial Volume
-
VWAP
-
Average Volume (3m)
8,656
Shares Outstanding
131,448,444
Dividend Yield
-
PE Ratio
-3.92
Earnings Per Share (EPS)
-0.01
Revenue
-
Net Profit
-1.34M

About Burzynski Research Institute (PK)

Sector
In Vitro,in Vivo Diagnostics
Industry
In Vitro,in Vivo Diagnostics
Headquarters
Wilmington, Delaware, USA
Founded
1970
Burzynski Research Institute (PK) is listed in the In Vitro,in Vivo Diagnostics sector of the OTCMarkets with ticker BZYR. The last closing price for Burzynski Research Insti... (PK) was $0.04. Over the last year, Burzynski Research Insti... (PK) shares have traded in a share price range of $ 0.013 to $ 0.085.

Burzynski Research Insti... (PK) currently has 131,448,444 shares outstanding. The market capitalization of Burzynski Research Insti... (PK) is $5.32 million. Burzynski Research Insti... (PK) has a price to earnings ratio (PE ratio) of -3.92.

BZYR Latest News

PeriodChangeChange %OpenHighLowAvg. Daily VolVWAP
1000.04050.04050.040515000.0405CS
40.010233.66336633660.03030.050.0303104040.04395851CS
120.00051.250.040.050.030386560.04390046CS
26-0.0015-3.571428571430.0420.050.013125160.03467385CS
52-0.03-42.55319148940.07050.0850.013111020.04440015CS
1560.009530.64516129030.0310.15750.012286780.04006518CS
2600.009430.22508038590.03110.15750.0061226430.03620464CS

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BZYR Discussion

View Posts
sunspotter sunspotter 3 weeks ago
In February 2017, following lengthy hearings, the Texas Medical Board recommended Burzynski's medical license be revoked, with the revocation suspended, and a fine of $360,000 for billing irregularities and other violations...........

A Reuters fact-check concluded that "Online claims that the drugs are a cancer 'cure' and that any of them has been FDA-approved, are misleading."

Although the therapy is promoted as natural and benign, it is in reality a form of chemotherapy with harmful side effects including severe neurotoxicity."

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

One day soon, and it can't be soon enough, Satan and all his imps will be torturing Stanislaw for all eternity.

They're already warming up on his late wife and literal partner-in-crime, Barbara.
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sunspotter sunspotter 1 year ago
Stanislaw Burzynski belongs in Hell. I hope he gets there soon.
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sunspotter sunspotter 1 year ago
“In spite of the success of his therapy, he has faced the prosecution of big pharma and the FDA which has tried to stop his therapy from spreading in the United States.”

His “therapy” never worked, except to make him a multi millionaire.

Stanislaw Burzynski belongs in Hell. I hope he gets there soon.
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StocktonCA StocktonCA 1 year ago
Documentary on Stanislaw R. Burzynski’s revolutionary cancer cure treatment based on his discovery on the mechanics of cancer, which lead him to the creation of the Antineoplaston Therapy. Dr. Burzynski’s Therapy has successfully cured thousands of terminal cancer patients for the last 30 years and has demonstrated to be 3 to 5 times more effective than the conventional chemotherapy and radiation treatments.
In spite of the success of his therapy, he has faced the prosecution of big pharma and the FDA which has tried to stop his therapy from spreading in the United States.
Visit the Burzynski Clinic and learn more about the ANP Therapy here:
http://www.burzynskiclinic.com
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sunspotter sunspotter 1 year ago
https://www.quackometer.net/blog/2012/03/the-burzynski-millions.html

The Burzynski Millions
19th March, 2012 Andy Lewis Burzynski 48

Dr Stanislaw R. Burzynski presents himself as a lone maverick doctor, struggling against the vested interests and great wealth of the medical profession. He claims to have found a safe and effective form of cancer treatment that can save children with the deadliest forms of cancer. But he claims the medical authorities and “Cancer Industry” do not want you to know this and will try anything to shut him down. They have their millions to protect.

Burzynski came to America from Poland “with twenty dollars in his pocket, a theory in his head, and an indefatigable attitude that shown in his smile.” He had an idea, that a chemical extracted from urine, could cure cancer. From that humble beginning, he has fought the authorities to build the clinic and laboratories needed to give life to children where all others are happy to see them die rather than lose their profits.

And so, when parents of desperately ill children from around the world hear about the Burzynski Clinic, they will have to find the money themselves. The UK’s NHS will not fund it, nor will health insurers. But his experimental protocols are not cheap and the many months of treatment will require hundreds of thousands of dollars. The only way for most parents to be able to afford to clutch at this straw is through massive fund raising appeals and the kind hearts of celebrities who help out. Newspapers and TV leap on the story of the beautiful and dying children being helped by well known faces such as Peter Kay, Radiohead, Badly Drawn Boy and Cheryl Cole.

In order to struggle on with his pioneering work, he asks you to donate and send him personal cheques.

There is, of course, another side.

Burzynski’s critics argue that in the 30 years he has been researching his antineoplaston therapies, he has failed to publish any convincing data. He has been running so-called trials for decades and yet there are no peer-reviewed articles that would allow others to objectively assess his results. He relies on testimonials and advertising to appeal directly to patients whereas such cases should normally be referred.

Stanislaw Burzynski has also been accused of massively overcharging his clients for their treatment, for not disclosing his ownership relationship with a pharmacy that sells his products, and treating patients ‘like cash machines’. His financial management of his Research Institute has been described as rendering the investment” “worthless” as cash is written off and in so doing so, ‘shafting his investors’.

He is currently under investigation by the Texas Medical Board for “failure to practice medicine in an acceptable professional manner”, negligence, lack of professional diligence, failure to disclose to patients the nature of their treatments, failure to obtain informed consent, providing medically unnecessary services to a patient and behaving in “unprofessional or dishonorable conduct that is likely to deceive or defraud the public or injure the public”.

His treatments, far from being an alternative to chemotherapy are just a mish-mash of conventional chemo given in highly unconventional ways and orphaned drugs with no good evidence behind them. He also sells a bizarre range of anti-aging creams and vitamin food supplements.

And when Burzynski is criticised he hires goons to try to shut people up.

In the context of this gulf between the two views of Dr Stanislaw Burzynski, last night I tweeted a couple of Google Earth images of where Dr Burzynski lives. This was bound to be controversial and, no doubt, this post will attract some criticism. Indeed, what I am about to do is conduct an ad hominem argument. But I shall explore this later.

So, here are the pictures.

burzynski

burzynski2

Dr Burzynski is obviously not financially struggling. This is a 10 acre, 15 thousand square foot, $6 million dollar residence with 15 bathrooms, saunas and swimming pools.

No matter which version of the truth you wish to believe, I think it is worth understanding that having come to America with $20, Dr Burzynski has done very well for himself with his 30-year-old, unproven, urine-derived cancer therapy, and that the fund-raising efforts being conducted by all those celebrities and media outlets are, at least in part, going to help pay for someone to polish those foot-high gold initials on Dr Burzynski’s gate next to the guard house to his residence.

Of course, I immediately saw some criticism for posting what might be seen as private and personal information and for me being hypocritical.

Indeed, most of the time I am very critical of people who use ad hominem attacks. That is, when the argument resort to attacking the personal characteristics of a person rather than the science and evidence. It is a common tactic amongst homeopaths and other quacks to respond to criticisms of the science with accusation that the critic is a shill, for example. However, when the question is about the personal characteristics, morals and motives of an individual then discussing the individual is not a fallacy. Understanding that Burzynski is a very wealthy man is an important factor in understanding what is going on since he is directly accused of overcharging and financially exploiting the desperation of families hit with cancer.

Burzynski charges his patients to take part in his own clinical trials. He is only allowed to treat patients with antineoplastons from within a trial. And unlike participants in other medical trials, Burzynski charges them a huge amount of money – hundreds of thousands. Thus, if Burzynksi’s treatments are found to work, then the financial risk of that investigation is being taken by his patients – people with cancer. If the trials are not positive, then Burzynski will still have gained financially and his patients will have lost both their lives and their money. It would look as if, he is not taking any risk at all in these trials. That is a unique position to be in. His patients are carrying all the risks associated with his research. And it is worth noting again, that when people sign up to trials, they expect their participation to benefit humanity – and that can only be done by publication of results. Thus, a failure to publish is a moral outrage.

His current and future patients should understand these issues and come to their own conclusions.

It has also been suggested that posting such pictures is somehow ‘intimidatory’.

Indeed, when 17 year old blogger Rhys Morgan first posted about Burzynski last year, the hired gangster, Marc Stephens told Rhys to take down his blog posts and sent him pictures of his house. Am I doing the same thing?

Context is everything. Stephens sent pictures to Rhys as a threatening manoeuvre. I am not threatening Burzynski. I am not sending him the message, “I know where you live”. I am providing evidence of the vast amount of money accumulated through the treatment of people with cancer and to show that this is not the story of the wealth of vested interests against a lone struggling researcher. I am not prone to do such things – but I think we are dealing with quite an exceptional case where Burzynski himself has created the framework of the argument about how he is being attacked by vested interests worth millions.

Indeed, even if Burzynski’s cures could be shown to be effective, such accumulation of wealth would have to raise eyebrows. Why is Burzynski not doing everything in his power to ensure that doctor’s world wide are using his approach? Why is he not getting help from other doctors and laboratories to gain the benefits of scale in producing his treatments. Why is he keeping his data, results and methods all to himself?

I think there are only a few credible answers to these questions and I don’t think they need spelling out.
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sunspotter sunspotter 1 year ago
Yeah. $460 down the drain for some poor sucker.

Could be worse- they could have given their life savings to that murderous crook Burzynski like so many suffering families have.
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BJ2018 BJ2018 1 year ago
wow what a run! sorry sunspot
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sunspotter sunspotter 1 year ago
Worth repeating:

"Stanislaw Burzynski’s propaganda victory on antineoplastons: The FDA caves Posted by David Gorski on March 24, 2014 Mark Crislip, founder of the Society for Science-Based Medicine, whose board of directors I’m proud to be serving on, an organization that you should join if you haven’t already, sometimes jokes that our logo should be an image of Sisyphus, the king of Ephyra whom Zeus punished by compelling him to roll an immense boulder up a hill. However, the boulder was enchanted and, as soon as Sisyphus reached the top, it would roll back down the hill. Sisyphus was thus forced to repeat this action throughout all eternity. The metaphor is obvious. Those of us who try to combat quackery and the infiltration of pseudoscience in medicine often feel a lot like Sisyphus. I always used to argue that, as amusing as it might be to have such a logo as an “in” joke, it’s far too much of a downer to inspire what SSBM wants to inspire: Action in the form of volunteers taking on projects, such as converting Quackwatch into a wiki and then continuously updating and adding to that wiki indefinitely. We have to believe that there is hope of someday succeeding. “Let’s push that boulder up a hill one more time!” does not exactly constitute an inspiring rally cry, although I can definitely understand the feeling at times the older I get and the longer I’ve been doing this. We can all appreciate gallows humor at times, and, besides, I’m not that pessimistic. I can’t afford to be. Even so, I can understand the Sisyphus analogy right now with respect to an unfortunately frequent subject of this blog, the doctor in Houston who proclaims himself a cancer doctor, even though he has no formal training in medical oncology, isn’t even board-certified in internal medicine, the prerequisite for undertaking advanced training in medical oncology, and has no discernable training in clinical trials management. I’m referring, of course, to Stanislaw Burzynski, MD, PhD, the Polish doctor who since 1977 has been treating patients with substances that he has dubbed “antineoplastons” (ANPs). What are ANPs? Burzynski claimed to have discovered ANPs during his time at Baylor and described them as endogenous cancer-fighting chemicals in human blood and urine. Unfortunately, he soon became convinced that only he could develop them into an effective chemotherapy drug and left Baylor to administer ANPs to his own cancer patients. Patients flocked to him because he claimed to be able to cure cancers that conventional medicine can’t cure. This led to a series of battles between Burzynski and various authorities, including the Texas Medical Board, the FDA, and various attorneys general, because of his use of ANPs, which are not and never have been FDA approved, as well as for various—shall we say?—issues with insurance companies. Ultimately, in the 1990s Burzynski beat the rap and effectively neutered the FDA’s case against him by submitting dozens of clinical trials to the FDA for approval, which, given how much pressure the FDA was under from Burzynski’s friends in high places (like Texas Representative Joe Barton), the FDA ended up approving. However, as Burzynski’s lawyer himself bragged, these clinical trials were shams designed to allow Burzynski to keep treating cancer patients, not clinical trials designed to produce any real evidence of efficacy. Not surprisingly, although Burzynski has published the odd case report or tiny case series, he has not yet published the full results of even a single one of his many phase II trials. There is, quite simply, no convincing evidence that ANPs have significant antitumor activity in vivo in humans, even after 37 years. Meanwhile, the FDA has found numerous examples of Burzynski’s abuse of clinical trials, failure to keep necessary data, and failure to protect human subjects, while exposés by BBC Panorama and Liz Szabo at USA TODAY have been most unflattering, revealing at least one dead child as a result of the toxicity of Burzynski’s drug and a pattern of minimizing and hiding reports of adverse reactions. I had at least two other ideas for what I thought would be informative, entertaining, and timely posts, but then late last week I found out about a new development in Burzynski’s latest battle to try to use patients as weapons again to bring pressure to bear on the FDA (as he did in the 1990s) to allow patients with brain tumors to be treated with ANPs under single patient INDs, also known as compassionate use exemptions or expanded access programs. Such exemptions allow some patients who have no good conventional options access to unapproved investigational agents. Ironically, one of the most damning findings about the Burzynski Research Institute and Burzynski Clinic from the FDA investigation last year was how Burzynski would play fast and loose with the rules regarding approval by the institutional review board (IRB) of such exemptions. IRBs are committees mandated by the Office for Human Research Protections (OHRP) to protect human research subjects by approving and monitoring clinical trials to make sure that patients are not placed at undue risk, that proper informed consent is given, and that clinical trials conform to all ethical and legal requirements. Let’s just put it this way. The FDA caved. You’ll see what I mean shortly. Worse, it caved in a way that basically abdicated its responsibility. Those of you who read my not-so-super-secret other blog will realize that I’ve already begun the discussion over there, making part of this post repetitive. However, there have been new developments over the weekend, and I very much want a record of this abdication of duty by the FDA on this blog as well—in more detail, of course. “Just when I thought I was out, they pull me back in.” Sadly, the brief little quote from Michael Corleone (as played by Al Pacino) in The Godfather, Part III, basically sums up my feelings with respect to Stanislaw Burzynski. Every time I think that I can give the topic a rest for a while (and, believe me, I do want to give it a rest), something invariably seems to happen to pull me back in. So it was Thursday evening, when I was made aware of a new development so disappointing that I’m still wiping the dirt off my chin from my jaw dropping to the floor. Even more amazing is that my disappointment stems from my perception of cynicism that actually was not Burzynski’s, but rather by the FDA in response to Burzynski’s cynical use of cancer patients as shields and weapons against the FDA that has led some of us who support science-based medicine to be subjected to criticism from the families of patients with cancer, who have been erroneously convinced that Stanislaw Burzynski is their loved ones’ last chance to survive. Actually, I can’t tell if it’s a cynical move or a breathtakingly naïve move, but it’s a huge mistake regardless, as you’ll see. I’m guessing that some will think of it as a very clever move, and so it is, but it’s a cleverness we could use less of. About a year ago, Burzynski was once again investigated by the FDA. Because of the death of a patient due to hypernatremia (elevated sodium level) due to ANPs in 2012, the FDA put a partial clinical hold on his pediatric clinical trials and extended it to all of his clinical trials. What this means is that, although Burzynski can continue to treat patients who are already in his clinical trials, he can’t enroll any new patients in them. Of course, one of the big issues with Burzynski that contributed to his problems is that he abused the FDA process known as the single patient IND, which is more commonly known as the compassionate use exemption. These are special case exemptions in which a single patient is allowed access to an investigational agent outside the auspices of a clinical trial. Indeed, when the FDA slapped him down most recently, in December, one of its findings was just that: Burzynski abused the single patient IND process and his institutional review board (IRB), the committee that’s supposed to oversee clinical trials and safeguard the interests and safety of clinical trial subjects, played fast and loose with the rules. Since the appearance of a USA TODAY story by Liz Szabo spelling out all of these issues, Burzynski has been frantically trying to save his empire. Whether “encouraged” by Burzynski or just by one of the patient groups that have become true believers, patients with deadly cancer have been starting petitions, pressuring legislators to intercede on their behalf to the FDA, and paint Burzynski’s ANPs as their only hope of survival. I have no doubt that these patients believe it, but they have the potential to inadvertently do great mischief to the law, either through their use of their tragic stories to promote misguided “right to try” laws or through their use of patient stories to pressure the FDA to loosen protections on human subjects in clinical trials. Perhaps the most tragic story is that of Rafael Elisha Cohen, a six-year-old child with medullablastoma who is not doing well and whose parents have been at the forefront of pressuring the FDA. As horrible as the Cohens’ situation is—and we all understand that it’s a horrible, horrible thing to have a child dying of brain cancer—unfortunately, the FDA appears to have decided to cave. The other day, on a Facebook page dedicated to raising money and pressuring the FDA, Devorah Teicher Cohen announced: UPDATE- Thanks to everyones hard work the FDA did end up approving the Antineoplastins for compassionate use – they do not let Dr B administer it. The condition is, if an oncologist request this protocol FDA will issue compassionate use within 24 Hours. FDA recognizes the data of those who survived aggressive brain tumors due to the ANP and is therefor after a long and cruel wasting TIME period allowing it. There are currently 8 pediatric patients that need this medicine NOW!!!! Refael Elisha can not travel at this point…so we would need an oncologist in the NY area… we are in touch with other kids that are ready to get on a plain if they get the signal of a cooperating oncologist. It is beyond words to express our sadness that FDA ended approving the drug but Elisha is in critical condition at the moment. We are not holding our breath and are trying different alternatives , If HASHEM wills it we will get the medicine but if not, that is from Hashem for the good. in the meantime Please put your fillers out there and message me in privet if you have any leads , even if not in NY it might work out for the other desperate children. im copying the announcement from ANP site Wanted: One brave courageous oncologist or oncologists willing to examine and treat up to eight pediatric brain cancer patients who have run out of treatment options and now require a Compassionate Use IND Emergency Treatment protocol from the U.S. Food and Drug Administration. The ANP Coalition needs your help now. Please visit www.anpcoalition.org or call (925) 699-9116. Thank You When I first saw this message on the Prayers for Elisha Facebook page, I was cautious. I could find confirmation of this news nowhere else, not even on the ANP Coalition webpage. Then, on Friday afternoon, Liz Szabo, the USA TODAY reporter who previously published her epic expose of the Burzynski cancer machine back in November, basically confirmed the report with a followup story in USA TODAY, FDA agrees to let patients get controversial drug: The Food and Drug Administration has agreed to allow a handful of cancer patients to receive unapproved drugs from a controversial Texas doctor, but only if they can find another physician to administer them. The drugs are made by Houston doctor Stanislaw Burzynski, who was the subject of a USA TODAY investigation last year. While his supporters consider him a medical maverick, mainstream doctors describe him as a snake-oil salesman. Burzynski has claimed for more than 36 years to be able to cure certain hard-to-treat brain tumors with drugs he calls antineoplastons. The National Cancer Institute notes that Burzynski has never published definitive evidence that his drugs cure cancer or even help people live longer. Burzynski has been unable to give these drugs since 2013, when the FDA placed his experiments on hold after the death of a 6-year-old New Jersey boy taking antineoplastons. In December, the FDA sent Burzynski a warning letter, noting that he inflated his success rates and failed to report side effects and to prevent patients from repeatedly overdosing. The Texas Medical Board also charged Burzynski last year with false advertising. None of this stopped the FDA from caving: The FDA acknowledged Friday that it has agreed to allow them to use the experimental drug, but only if they can find a qualified, independent physician to administer the drug. Beyond infusing the drug and overseeing their care, the doctor would have to formally apply for expanded access to an “investigational new drug,” as well as get approval from an institutional review board, an independent panel that reviews safety and ethical issues involved in clinical trials. Can anyone figure out why I can’t make up my mind whether this decision, if what the Cohens say is true, is stunningly cynical or stunningly naïve on the part of the FDA? Instead of standing firm for science and gently continuing to point out that it can’t allow any more single patient INDs for ANPs be approved based on science, Burzynski’s past violations of FDA regulations, and, above all, the need to follow the FDA’s mandate and mission to protect vulnerable cancer patients, instead the FDA has dangled more false hope of a single-patient IND in front of Elisha’s family (and the eight other children petitioning for such INDs). It’s hard to believe that the FDA is not aware that it is incredibly unlikely that any reputable pediatric oncologist would agree to administer ANPs under these conditions, given Burzynski’s reputation. In a way, what the FDA is doing inadvertently compounds the families’ agony. Now they have hope again, except that this time it’s doubly false: False because, based on existing evidence and what we know now, ANPs almost certainly don’t work and false because of how incredibly unlikely it is that any pediatric oncologist will take on such a patient and administer ANPs, given Burzynski’s history, the utter lack of supporting science for the efficacy of ANPs, and the not-inconsiderable amount of work and expense that would be necessary in order to do so. The families will now be showing up in the offices of pediatric oncologists, begging them to agree to do a single patient IND and administer ANPs to these patients. Ditto some adult oncologists. Indeed, according to Szabo’s report, Liza Covad-Lauser, wife of rock star Sammy Hagar’s drummer David Lauser, claims that she has already found a doctor willing to administer the antineoplastons. One wonders if this doctor knows what he is getting himself into. As cynical as it might sound of me to say so, I can’t help but wonder whether being the wife of a member of a rock star’s band, who can garner signatures on petitions by other rock stars, has an effect. Here’s why the FDA’s action is doubly cynical (or nave). As alluded to in Szabo’s article, according to FDA regulations, there are a number of requirements for a single patient IND and several things any physician seeking to administer an investigational agent as a single patient IND must do. Here’s the most important one that makes it even more unlikely that any single patient IND will be granted, except for perhaps briefly as an “emergency exemption” in which IRB approval can be briefly deferred: 5. Informed Consent Statement that states that informed consent and approval of the use by an appropriate Institutional Review Board (IRB) will be obtained prior to initiating treatment. In the case of an emergency, treatment may begin without prior IRB approval, provided the IRB is notified of the emergency treatment within 5 working days of treatment. See what I mean? Even if a family were to find an oncologist willing to jump through all the hoops to get a patient on a single patient IND to be treated with ANPs, that single patient IND would still have to be approved by the IRB of the institution where that oncologist practices. Sure, the oncologist could declare the treatment an “emergency”—although in none of the cases that I’m aware of other than that of Elisha Cohen could be properly termed an emergency so urgent that the physician couldn’t wait a week or two to have the IRB formally discuss the IND, even if ANPs actually did have any efficacy—and start treatment pending IRB approval, but as soon as the IRB convened to discuss the IND, very likely the plug would be pulled. No more ANPs. Remember, these would be real IRBs, not Stanislaw Burzynski’s sham IRB chaired by an old crony of his. There’s another question to consider. Stanislaw Burzynski routinely used to treat some of these patients for free, supplying ANPs for no cost and waiving case management fees. No doubt this offer was primarily for publicity, to blunt the accusation that, based on the exorbitant amounts of money charged to previous patients, Burzynski is in it for the money. So, not surprisingly, according to Szabo’s report, Burzynski is still offering to provide the drug for free. That’s all well and good, but it leaves all the other expenses of treatment, which will not be paid for by insurance because ANPs are not an FDA-approved drug. Who’s going to pay for all of that? While it is true that some of the families have raised quite a bit of money (Elisha’s family, for instance, has raised nearly $150,000), others aren’t so lucky. A massive Burzynski propaganda victory? Supporters of Stanislaw Burzynski wasted no time in using the FDA decision to defend Burzynski and, ironically, to attack the FDA. Many of you might remember McKenzie Lowe, the 12-year-old girl diagnosed with diffuse intrinsic pontine glioma (DIPG) in 2012. Her family has been trying to have her treated by Stanislaw Burzynski, making videos and lobbying Congress. Indeed, they succeeded in persuading their senator, Senator Kelly Ayotte (R-NH), to write to the FDA urging it to consider allowing McKenzie to be treated by Burzynski. On a Facebook page Friends of McKenzie Lowe, a message was posted on Sunday simultaneously rejoicing at the news as evidence that McKenzie has a chance to live and lambasting Liz Szabo: As you all probably have read in the USA Today the FDA has agreed to let Mckenzie and the other people who want to use ANP CAN USE IT!!!! FANTASTIC!!!!! But as you can see the writer of the article is very bias on the negative side. As usual she one again took something good for these patients and in stead of focusing on the positive response from the FDA she took another swing at bashing Dr. Burzynski and his clinic. There was no mention of or comments from Anthony Stout, Rick Schiff, Jessica Ressel, Randy Hinton, Philip Norton and many many more.. Let’s go back in history to all the nay Sayers that said Christopher Columbus was crazy. The world is flat, you will fall off the end. Hmmm. Einstein was a quack… Hmmm. Isaac Newton and Galileo were also shunned by their peers… Thank god they had the fortitude to push aside the nay sayers and continue to prove them ALL wrong. Imagine where we would ALL be today if they had listened to their critics and not persevered with what they believed. Unfortunately, this is known as the Galileo Gambit, a nice, concise term used to argue that if you are vilified for your ideas it must mean that you are right. Unfortunately, what supporters of pseudoscientists and quacks frequently forget is that there are two requirements necessary to be able to credibly claim the mantle of Galileo. Not only must you be vilified, but you must be correct. Only one of these applies to Stanislaw Burzynski, and it isn’t the second one. As has been the case whenever I’ve discussed patients like McKenzie Lowe, Liza Covad-Hauser, Rafael Elisha Cohen, and others, I understand, at least as much as it is possible to understand without actually being in their shoes. As I’ve pointed out before, it was only five years ago that my mother-in-law died of widely-metastatic breast cancer. Burzynski couldn’t have saved her. ANPs couldn’t have saved her. And I know I’m going to take some flak for saying this, but ANPs cannot save McKenzie Lowe. At least, there is no convincing evidence that they can, and, quite frankly, the only blame for why this is true should be placed at the feet of Stanislaw Burzynski himself. He’s the one who, thinking himself the “brave maverick doctor” to whom the rules of science don’t apply, has failed to produce such evidence. While I understand the desperation these families are feeling, I keep hoping that they will realize that it is not doing McKenzie, Elisha, or any of the others any favors to subject them to toxic chemotherapy—and, make no mistake, ANPs are toxic chemotherapy, efforts of advocates to paint them as “natural” and “nontoxic” notwithstanding. As I’ve pointed out time and time again: If there’s anything worse than dying of a terminal illness, it’s dying of a terminal illness and suffering unnecessary complications or pain for no benefit in the process. I can totally understand why families like the Lowes might become very excited about the possibility of being able to use ANPs. As misled as they have been and mistaken as their belief is, they do, after all, genuinely believe that ANPs represent the last chance their loved ones have to be able to survive their cancer. Unfortunately, our old “friend” and Burzynski’s very own propagandist, Eric Merola, who has produced two fawning “documentaries” about the Great Man chock full of misinformation and exaggerations, coupled with attacks on Burzynski critics and skeptics, has no such excuse and deserves none of the compassion that we should all have for patients dying of brain tumors and the families who love them. Not surprisingly, he, too, has leapt into the fray with a typically frothing-at-the-mouth conspiracy-laden pile of fetid dingos’ kidneys of a response to Liz Szabo’s story, in which he examines it line-by-line and basically responds with typical Burzynski propaganda, misinformation and lies. There’s too much there for a full response in this post. Besides, most of the misinformation that’s there I’ve covered before, often multiple times. Perhaps I’ll respond a bit more on my not-so-super-secret other blog. Here, I simply want to point out a few of the most egregious examples. For example, here is probably the most egregious lie on Merola’s part: A DIPG in a child has never been cured in medical history — why would the FDA make such a claim in this case? It’s quite simple, the science proved it works and cures in many cases, and therefore the science was allowed to progress. There are no “claims” other than what can be proven. Maybe it’s because the cancer industry doesn’t like anyone else “claiming” anything as they own the luxury of claiming what cancer medications work or not work — and we know how well that has worked out for us. As I’ve pointed out before, this is, quite simply, untrue. It’s also been pointed out time and time again to Merola that this is untrue. Long-term survival for patients with DIPG is rare, definitely, but it’s always dangerous to make an absolute statement like the one that Merola has done. Contrary to Burzynski’s claim, there are occasional long-term survivors, some of whom received little or no therapy, such Connor Frankenberg, a child from Germany, and two patients who underwent spontaneous remission. There is even a site, the DIPG Registry, whose purpose is reporting on how patients with DIPG do and promoting Just One More Day, a registered non-profit 501(c)(3) organization dedicated to helping families affected by a diffuse intrinsic pontine glioma, established by the families of DIPG victims. The DIPG Registry concludes that, although the vast majority of children with DIPGs do poorly: The bottom line is: 1) we really don’t understand DIPGs, and 2) there are children who have been diagnosed with DIPGs-based on the incomplete knowledge that we currently have- who truly have had spontaneous regression of their tumors and 3) most of the children with reports of spontaneous regression have been very young. Young like Tori Moreno, I might add. The big problem is that Burzynski appears not to keep good enough records to demonstrate one way or the other whether he can cure DIPG, and we already know from recent FDA findings and Liz Szabo’s USA TODAY report that he has misclassified partial and complete responses. Yes, DIPG is a horrible disease, with only 10% surviving beyond two years. Unfortunately, there is no convincing evidence that Burzynski can do any better than conventional oncology, much less cure DIPG, as much as his propagandist Eric Merola repeats the claim that he can. Worse, Burzynski hasn’t published a single one of his completed phase II clinical trials, even though he’s had well over 15 years to complete them. With tumors this lethal, most such trials should be completed within five years, which brings us to more of Merola’s misinformation: The National Cancer Institute notes that Burzynski has never published definitive evidence that his drugs cure cancer or even help people live longer. The above links are examples definitive published evidence. Notice how this writer links to a PDF highlighting her point, vs. the National Cancer Institute (NCI) website itself. Is it perhaps because on the NCI website it clearly says: “A phase II study also conducted by the developer [Burzynski] and his associates at his clinic reported on 12 patients with recurrent and diffuse intrinsic brain stem glioma. Of the ten patients who were evaluable, two achieved complete tumor response, three had partial tumor response, three had stable disease, and two had progressive disease. Patients ranged in age from 4 to 29 years.” The NCI felt its own source to be “definitive enough”, why not Liz? *Source: www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page5#Reference5.12 Merola clearly does not understand the difference between “responses” and cures. Similarly, he does not understand what constitutes “definitive evidence.” (Hint: It isn’t case reports, tiny case series published in bottom-feeding journals, or incomplete phase II trials. Moreover, just because the NCI cited a crappy review article by Burzynski that reported partial results phase II trials, a ten year old partial report of a phase II trial, a dubious paper published in an integrative medicine journal, and another review article published by Burzynski in a journal that appears not to be even indexed by PubMed does not constitute “definitive evidence” that ANPs work. All it means is that the NCI was examining the existing published evidence on its way to writing this: To date, no randomized controlled trials examining the use of antineoplastons in patients with cancer have been reported in the literature. Existing published data have taken the form of case reports or series, phase I clinical trials, and phase II clinical trials, conducted mainly by the developer of the therapy and his associates. While these publications have reported successful remissions with the use of antineoplastons, other investigators have been unable to duplicate these results [10] and suggest that interpreting effects of antineoplaston treatment in patients with recurrent gliomas may be confounded by pre-antineoplaston treatment and imaging artifacts.[11,14,16] Reports originating from Japan on the effect of antineoplaston treatment on brain and other types of tumors have been mixed, and in some Japanese studies the specific antineoplastons used are not named.[9] In many of the reported studies, several or all patients received concurrent or recent radiation therapy, chemotherapy, or both, confounding interpretability. Mr. Merola, that’s hardly “definitive”! Nor is the “definitive” study by Hidaeki Tsuda featured in the second Burzynski movie, given that nothing has been published to allow us to evaluate the methods. Nor is the fact that The Lancet Oncology apparently editorially rejected a manuscript submitted by Burzynski evidence of any sort of “conspiracy” against him. Indeed, I now probably know why Burzynski’s manuscript was rejected. Look at the title: “Glioblastoma multiforme: A report of long-term progression-free and overall survival of 8 to over 16 years after antineoplaston therapy and a review of the literature”. Yes, the title seems to indicate that this is just another small case series. No wonder The Lancet Oncology didn’t even bother to send it out for review! Of course, Merola can’t resist a swipe at yours truly, who was quoted in the article: A guy who is paid to write blogs attacking this innovation and other innovations that compete with the status quo, a guy who has never once met a Burzynski patient, never once visited the Burzynski clinic, a guy who supposedly finished his residency and now writes “thought police” blogs for a living — yeah, let’s hear more about what this guy has to say, that’s productive. He does fit the angle for Liz’s one-sided propaganda, so I understand why she included his irrelevant opinion. I don’t know whether to laugh or be annoyed at Merola’s continued lies about me. Once again, I do not need to visit the Burzynski Clinic to know that ANPs almost certainly don’t work. I did finish my residency and am board certified in surgery. If Mr. Merola doesn’t believe that, he can go to the American Board of Surgery website and search for my name in the section that lets the public verify the board certification of surgeons, realizing that you can’t become board certified without finishing an accredited residency. Finally, I don’t actually blog for a living. It’s my hobby. I’m not paid at all for my work at SBM, and at my not-so-super-secret other blog I make a small amount of money that I could completely do without if that gig ever went south or I decided to bolt. As for having something worthwhile to say, well, let’s just say that I’d put my record for science-based analysis against Mr. Merola’s record for pseudoscience-based propaganda any day, particularly in light of his latest paean to another brave maverick, this time promoting the long-discredited cancer quackery known as laetrile. At least Merola included a link to my page on SBM. He seems to think it’s something nefarious, while I’m more than happy to include a link to it here. Please, read. Why did the FDA cave? What is puzzling to me is why the FDA caved. While it is true that the ANP Coalition managed to get a few misguided legislators, the most prominent of whom was Senator Kelly Ayotte (R-NH), to write letters to the FDA urging that it consider allowing ANPs to be made available through single patient IND/expanded access to their constituents, the letters were fairly wishy-washy. Moreover, the Change.gov petition to the White House response to a We The People online petition to have the FDA allow Elisha Cohen access to ANPs through compassionate use exemption resulted in a response that, boiled down to it essence, said that it’s the FDA’s job to make such decisions, and let the FDA do its job, along with links to various FDA web pages with information about investigational drugs and information about how the FDA could be contacted. It was a shockingly reasonable response. One rationale reported in Szabo’s article seems to be that by allowing ANPs to be used but excluding Burzynski from having anything to do with administering them other than producing them, in essence, relegating him to the role of a drug manufacturer, useful data might be obtained and patients protected while obtaining that useful data. This is utter nonsense. As Howard Ozer is quoted in Szabo’s article: “This is a cop-out,” says Ozer, director of the University of Illinois Cancer Center, who studied Burzynski’s research results in the 1990s. “Because it can be toxic and cause life-threatening sodium problems, patients (who take antineoplastons) are at risk and could die,” Ozer says. The scientific community will learn nothing by giving these patients antineoplastons, because there will be no comparison group, Ozer says. Any doctor who agrees to give antineoplastons could be biased in favor of them, which could skew the results. Exactly. As Dr. Peter Adamson points out in the article, after 37 years, if antineoplastons were the wonder drugs that Burzynski claims them to be, scientists would know it by now. ANPs aren’t wonder drugs. There isn’t even any evidence that they’re better than standard-of-care, as dismal as that is for DIPG. It is possible that one of the Senators or other legislators did indeed pressure the FDA, leading the relevant enforcement officials to come up with this decision in order to get them off their backs without actually doing anything. They could credibly say, “Hey, we offered compassionate use, but I’m sure you’ll agree that, given his history, we can’t let Burzynski be the one to administer the ANPs on compassionate use. Look at his history of playing fast and loose with IRBs and not obeying the rules with respect to INDs.” This might even sound convincing and seem clever, which is why I rather suspect that Dr. Henry Friedman is right when he says: “It will deflect criticism from anybody who says the FDA is unilaterally denying dying patients something that could help them,” says Friedman, deputy director of the Preston Robert Tisch Brain Tumor Center at Duke University in North Carolina, who also reviewed Burzynski’s studies in the 1990s. “It will get FDA off the hook.” That, I believe, is exactly why the FDA did it, not to help dying children. Unfortunately, the consequences of the FDA’s decision are likely to be disastrous. Long-suffering families will have false hope extended to them once again, only to find out that it’s a useless offer. In addition to continuing to scramble to raise money, they’ll scramble to find oncologists willing to do the not-inconsiderable work to get a single-patient IND approved and administer ANPs, something few, if any of them, are likely to succeed at. The families don’t know it yet, but what the FDA has done will only add to their misery. Indeed, I’ve already seen reports that patients have contacted “dozens” of pediatric oncologists looking for one who will administer ANPs, and, given that the number of pediatric oncologists in the US is small, a significant proportion of them are likely to be contacted. Meanwhile, Burzynski gets a propaganda victory, thanks to the FDA’s failure to enforce its own standards, and alt-med proponents get another conspiracy theory to add to the list of conspiracy theories surrounding Burzynski already." http://www.sciencebasedmedicine.org/stanislaw-burzynskis-propaganda-victory-on-antineoplastons-the-fda-caves/
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sunspotter sunspotter 1 year ago
And more:

'My Cancer Free Life'? Not So Fast
— Reality docuseries as a commercial for quack doc
by David Gorski, MD, PhD November 15, 2018

When I first encountered Stanislaw Burzynski and the Burzynski Clinic around a decade ago, I didn't know what to make of him. Sure, he seemed quacky, with all the testimonials of miracle cures and the claims that he cured deadly brain cancers, like diffuse intrinsic pontine glioma (DIPG), that conventional oncology could do no more than palliate. Sure, it was rather odd that he had never done a fellowship in oncology or an oncology-related specialty.

However, he was a Polish expat who seemingly was an excellent student. And he did have a brief career as a real cancer researcher at Baylor in the early 1970s. During that time he discovered the treatment for cancer (or so he thought) that led him to abandon Baylor around 1977 and set up a manufacturing facility to produce the treatment, which he had dubbed antineoplastons, and to administer them to patients, even though antineoplastons were not FDA-approved and for which, at best, Burzynski only had some relatively weak in-vitro evidence of anticancer activity, a story I wrote about in detail for Skeptical Inquirer 4 years ago.

Let's just put it this way: more than 40 years later, Burzynski has still failed to produce anything resembling convincing evidence that his antineoplastons are effective against cancer. But that hasn't stopped him from continuing to charge massive "management fees" that can run into the hundreds of thousands of dollars to administer antineoplastons to desperate cancer patients. Neither have multiple investigations by the FDA and the Texas Medical Board (TMB) driven him out of business.

Indeed, the most recent attempt by the Texas Medical Board to shut him down ended a year and a half ago in failure. Despite his having to pay a $360,000 fine and agree to submit to monitoring of his billing practices, to complete a medical ethics course (hilarious!), inform his patients that he owns the pharmacy he requires them to use, and submit his informed consent forms to the TMB for review, he's still out there attracting desperate cancer patients to his clinic. He even has a local TV station, KHOU-TV, running on its morning show Great Day Houston what is basically an advertisement for a new "reality" series called My Cancer Free Life, which is being produced by Uchenna Agu and features at least two Burzynski Clinic patients, Bo Edwards and Douglas Kruse, as testimonials for Burzynski's "miracle cures."

Here is the segment, which aired last week:


I had so many questions as I watch this eight-minute segment on Great Day Houston. Let's dig in, but, before I discuss the segment above in depth, let's first go through a little background regarding Burzynski and the media.

KHOU-TV has a history of promoting Burzynski

The first thing I wanted to know was why a local Houston TV station was promoting Stanislaw Burzynski. I had forgotten about it, but KHOU-TV has a long history of doing puff pieces on the Burzynski Clinic, so much so that Houston Press reporter Craig Malisow has even called them "B-jobs." For instance, here's a story from 2009 entitled "Controversial cancer doc: Proof on the way that urine treatment works." Its tagline? "Every day, cancer patients from all over the U.S. come to Houston for treatment. But some drive right past MD Anderson and head for Dr. Stanislaw Burzynski's clinic." It's a story full of false balance, with Burzynski touting how he's going to show that his antineoplastons work interspersed with a doctor from the MD Anderson Cancer Center saying that there is no evidence that it works. It, too, raised the ire of Malisow, and rightly so. Remember, too, that this was more than 30 years after Burzynski broke away from Baylor and started selling his treatments himself. In 2014, KHOU ran a story about how grateful Stanislaw Burzynski was for having gotten to meet Pope John Paul II in the 1980s and in 1996. Here's an excerpt:

Burzynski was recommended to the Vatican at a time when the Pope was rumored to be sick with colon cancer. The doctor was known for unconventional treatments, which did not involve surgery or chemotherapy.

'The government wasn't too nice for my husband's discovery,' said Dr. Barbara Burzynski, Burzynski's wife.

His treatments called Personalized Cancer Therapy are different from every other doctor. He said they target certain cancer cells to stop them from growing. Government officials and the medical community claimed his methods didn't work or at least, there wasn't any proof they did.

'I was being accused of a variety of things which I did not commit,' he said.

Thankfully the pope did not have cancer. But for his willingness to help, Burzynski was blessed with a medal from John Paul's successor, Pope Benedict XVI, which he feels is a strong endorsement of his techniques.

Yes, this really did happen. Also, let's just say that the Catholic Church or any other religion should not be trusted as a reliable guide to good medicine.

Also in 2014, KHOU-TV ran this nine-minute segment, "Overcoming cancer with the help of Dr. Burzynski," which was actually sponsored by the Burzynski Clinic:

This is pure propaganda, basically a brief infomercial for the Burzynski Clinic, complete with the host blathering about how other cancer centers are now adopting the methods of the Burzynski Clinic. (More on that later, but for now, I'll simply call that claim what it is: Nonsense. For example, Burzynski has basically claimed to have invented precision medicine. He did not.) There wasn't a single bit of misinformation or a single trope in this video segment that I hadn't heard before. In particular, he claims that he has a 50% 5-year survival for brainstem cancers, a claim for which Burzynski has never been able to produce anything resembling convincing evidence. The best evidence he can produce is not that good.

So we know right away that someone high up at KHOU-TV is a believer in Burzynski's quackery. Since 2016, Great Day Houston's producer has been Ralph Garcia, and its executive producer Kathy Richey, which implies it's someone higher up in the station who's interested in seeing pro-Burzynski propaganda aired. One wonders if it's Susan McEldoon, who's been the general manager there since 2007 and will be retiring soon. I couldn't find any evidence, though. Whatever the situation, it's clear that KHOU-TV has a thing for Burzynski. Who knows why or who it is who's responsible?

Who is Uchenna Agu?

I'm guessing that some of my readers recognize the name Uchenna Agu, but I must admit that I had no clue who he was when I first encountered this story. Yes, I was reduced to doing what I always do when I don't recognize a name: I Googled him. It turns out that Agu's fame comes from his appearance with his wife Joyce as contestants for The Amazing Race 7 in 2005 (which they apparently won) and later in The Amazing Race All-Stars in 2007. Since I don't think I've watched even a single episode of that show, I had no idea. In any event, he's also appeared in Push (2014) and Sanitatum (2018). (I know. That didn't help me either.) Apparently, he's now a producer and a managing partner at the consulting agency UEA Group.

As for the production companies involved, I noted a couple of interesting things. The blurbs under the story and on the YouTube page suggests Big or Small Media Entertainment, LLC for more information. Clicking on that link goes to an unclaimed domain and a GoDaddy page. They also mention video from TKGmediaproductions.com, which, it turns out, is owned by someone named Tony Garcia. I can't help but wonder if he's related to producer Ralph Garcia in some way.

My Cancer Free Life? It begins.

So let's get to My Cancer Free Life.

Given that there's minimal, if any, video footage shown in this segment promoting My Cancer Free Life, and I can't find any with my prodigious Googling skills, I couldn't help but wonder how early in production this "reality docuseries" is. Usually, in cases of a producer, director, or actor doing promotional interviews about his project, he'll be able to show at least a little footage. True, there is a brief clip at the beginning of the segment of Stanislaw Burzynski himself going on about how when he started it was the "dark ages of cancer treatment". Whether that was provided by Agu or was stock footage from past KHOU-TV infomercials on Burzynski, I don't know. It wasn't revealed. Ditto on some footage later in the segment of the Burzynski Clinic. I was impressed at how pedestrian it all looked. In any case, Great Day Houston host Deborah Duncan is next up to introduce the segment, which includes Uchenna Agu and the two Burzynski Clinic patients, Doug Kruse and Bo Edwards.

One thing that became apparent right away is that, unlike a lot of Burzynski Clinic patients, Kruse and Edwards maintain a low social media and Internet profile. Searches for their names plus "cancer" and/or "Stanislaw Burzynski" failed to turn up much other than this segment. Ironically, it turns out that Kruse once did comment on a blog that might be familiar to many of you on a post entitled How is it that in 2018 cancer Stanislaw Burzynski is still preying on desperate cancer patients? (Update). The date of the comment is August 6, 2018:

Dear Doctor. I say again....Hello! I came to Burzynski clinic March 2017 with stage 4 prostate cancer and kidney carcinoma. I responded well to treatment and returned to work at the office in December. This week my CT PET scan results are good and we are concluding treatment. I find several of the comments above blatantly false based on my experiences in being treated meeting with Dr. Burzynski about once a week for over a year. And, I have met in our IV room several who have recovered when standard of care was to go home and die, too. That includes one gentleman from Canada that go over pancreatic cancer as I observed week to week as a co-patient. I have spent the monthly cost for investment and am happy with the results noted. Request: Would you please increase the respectful part of your dialogue? Including complying with your own guidelines for comments and eliminating some of the abusive vocabulary, please. Respectfully, Douglas Kruse Jr. Houston, TX.


Clearly, there's not much in this comment to help me understand his testimonial other than that Mr. Kruse has stage IV prostate cancer and kidney cancer. It's not clear if he has both prostate and kidney cancer (which would be very unusual) or prostate cancer that's metastasized to the kidney (less uncommon). I'll discuss him more later on based on what he says on this KHOU-TV segment. As for Bo Edwards, I could find basically nothing about him other than links to the KHOU-TV segment. Searches on Facebook and Twitter didn't yield anything either. It's almost as though these patients were chosen for how little information about them is publicly available on Facebook, Twitter, YouTube, and various websites, even pro-Burzynski websites.

My Cancer Free Life? The propaganda is thick.

After we see Burzynski's smiling face going on about how the sequencing of the human genome was the milestone that revolutionized cancer treatment, Great Day Houston host Deborah Duncan reads an introduction that will make anyone familiar with Stanislaw Burzynski's four-decade scam cringe, so much so that I wondered if Burzynski himself had written it. She basically recounts that Burzynski discovered a gene-targeted cancer therapy back in the 1970s. This is, of course, ridiculous. Contrary to the hagiography of Eric Merola's two propaganda movies about Burzynski, Burzynski The Movie: Cancer Is A Serious Business and Burzynski: Cancer Is A Serious Business, Part II, in which it is claimed that Burzynski is a pioneer of "gene-targeted cancer therapy," Burzynski's two go-to treatments include the unproven and likely ineffective (antineoplastons) and the "make it up as you go along" (his "gene-targeted therapy").

Particularly risible have been Burzynski's arrogant, ego-fueled claims (mindlessly repeated on this segment) that he first described "gene-targeted therapy" and that he invented precision oncology, with major cancer centers like MD Anderson only now catching up to his vision. (I first saw this claim in Suzanne Somer's quackfest of a book, Knockout: Interviews With Doctors Who Are Curing Cancer And How To Prevent Getting It in the First Place.) It's a message parroted both by Duncan and Agu in this segment, and it's simply not true. Burzynski is not a "pioneer" in personalized gene-targeted cancer therapy and never has been. He is most definitely not a pioneer in immunotherapy either, contrary to Agu's assertion. That the segment starts out with a message painting Burzynski as a scientist ahead of his time tells me that what I'm seeing is propaganda far more than journalism and that Agu's docuseries will apparently preach this message tells me that Agu is more akin to Eric Merola than to a serious producer, at least when it comes to Burzynski. Let's just put it this way. If Burzynski had never been born, major cancer centers would be embracing precision medicine and immunotherapy now in exactly the same way, mainly because Burzynski has had zero positive effect on oncology.

When the camera pans out to show all the guests for the first time, my first reaction upon seeing Bo Edwards was that he looks very, very sick. Inexplicably, his whole right arm is bandaged and he has a catheter in place that is hooked up to a black bag that he's carrying. It makes me wonder if he's getting a continuous infusion of antineoplastons. In any event, he looks gaunt, and there's something funny about how his loose shirt sits on his bandaged right arm. Certainly, he does not look the way that Agu describes him (and Kruse), "cured of cancer."

In any event, we learn from Bo Edwards that the reason he went to the Burzynski Clinic after being diagnosed with stage IV cancer (type not yet specified) was because a friend of his wife with stage IV cancer (type not specified) had gone there 18 years ago and was cured. In any event, he was told that he could have chemotherapy (which probably wouldn't work); he could have radiation (which would likely only prolong his life marginally); or he could have radical surgery that would involve removing his arm, shoulder, and part of his upper chest. When I heard this, all I could think of was forequarter amputation, the same operation recommended to Jessica Ainscough, whose promotion of "holistic health" and alternative medicine led her to be known in Australia as the Wellness Warrior. She ultimately died of her disease after a very prolonged course, but what had frightened her from conventional treatment was the prospect of a forequarter amputation, a brutal operation that is rarely performed these days. Seeing Edwards' bandaged arm and hearing the recommendation that he have what sure sounded like a forequarter amputation, made me wonder if he has what Ainscough had, epithelioid sarcoma. In any event, the fact that he was offered such radical surgery suggested to me that he has some sort of sarcoma involving his upper arm and that he doesn't have metastases to distant organs. If he did, there's no way such radical surgery would even be considered.

So when was Bo Edwards diagnosed? It turns out that it wasn't that long ago. He was given the three options, according to his story, in January 2018, only 9 months ago. That's an awfully short time to be declared cured of any cancer. We're also shown zero evidence that Edwards is, in fact, cancer-free, as he claims. If he were cancer-free, I wonder, why is his arm bandaged and why is he still hooked up to an infusion device? As Edwards finished telling his story, I couldn't help but feel a wave of sorrow and empathy for him. He really believes he's been cured, and I hope he is, but everything about his story suggests otherwise and that he's just been fortunate thus far. I also couldn't help but notice that the Great Day Houston bug always seemed to be sitting over Edwards' other arm, where the infusion catheter was inserted under a bandage.

Mr. Kruse recounted his story next, and it was much as what you read in his comment cited above. He was diagnosed in March 2017. According to him, his wife took him to the emergency room then because his "system shut down," and he had high blood pressure. From the sound of it, he had prostate cancer metastatic to kidney and bone. He added that he was told that he should just go home and grieve with his family. Now, I suppose that's entirely possible, but it sounds a bit hard to believe. For one thing, prostate cancer, even metastatic prostate cancer, tends to be a slow-growing disease; it's not that surprising that someone with stage IV prostate cancer could be alive a year and a half after diagnosis. For another thing, treatments for prostate cancer have improved markedly since I was in medical school and residency. At a decent cancer hospital (and, let's not forget that M. Anderson is located in Houston), a patient with stage IV prostate cancer will be told that his disease is indeed incurable, but won't just be punted home as Edwards described. He'll be told that we have treatments that can slow down the progression of the disease and that he could have years left.

In fairness, I don't know the full extent of Kruse's disease. He didn't say, either in the blog comment above or on this segment on KHOU-TV. However, whenever I hear a story like his I wonder whether there was a misunderstanding of his prognosis or whether he went to a crappy hospital that doesn't do a lot of oncology. Again, I have no way of knowing from what I see here. In any event, Kruse's wife and daughter persuaded him to go to the Burzynski Clinic.

What does Burzynski do differently?

The final part of the segment began with Duncan asking Agu, "What does Dr. Burzynski do differently?" The answer told me just how deep the propaganda will be in this docuseries. I also wasn't too thrilled to see Agu invoke "right-to-try." After all, right-to-try is a scam designed to weaken the FDA, and Burzynski has been using it to get around the FDA. Agu then says that there is a DNA test that each patient must take before getting into the Burzynski Clinic, and "if you fall within that window, you're golden." At this point, I was shaking my head and wondering just what the heck Agu was talking about. He seemed to be implying that there was a small "window of opportunity" during which a patient can benefit from Burzynski's treatments. Given that Burzynski appears to specialize in extracting cash from patients who have advanced cancer, this statement makes little sense.

Duncan also pitched another slow, hanging ball right over the plate by asking, "Why isn't every treatment facility doing it this way?" If I were on the show, I'd have answered that the reason is simple. Burzynski has never shown anything resembling compelling evidence that his approach works better than what we do now -- or even that it works at all. Agu, of course, regurgitated an answer right out of the quackery defense league's manual about how cancer doctors have developed a "standard way" of treating cancer over the years such that "everyone is 'this is the way we do it' and it doesn't open the door to alternative treatment." In other words, it's the same old' same old'. Doctors are too close-minded. Doctors can't tolerate the competition. Doctors won't try anything different. He then went on to say that doctors should be referring to Burzynski "on the front end" after a DNA test to see if the patient "fits" (whatever that means).

Apparently, the docuseries won't just be about Burzynski, either, although clearly, it looks as though Burzynski will be a major focus. Agu says he'll also look at patients who have chosen conventional therapy and other alternative therapies. Anyone want to guess how well the ones who choose conventional therapy will do? I'm sure the selection will not be random. After all, Edwards and Kruse were given the opportunity to have almost the last word, which they took to go on about how Burzynski's given them hope. Unfortunately, I know otherwise. I know Burzynski. I've examined more testimonials by patients of his than I can remember, many of them analyzed right here on this blog. My friend Bob Blaskiewicz, who runs The Other Burzynski Patient Group, has done likewise. Basically, Burzynski's patients all pay tens or hundreds of thousands of dollars to be treated, often under sham clinical trials designed solely to let Burzynski avoid FDA actions. There is no good evidence that they do better than they would have done without Burzynski.

Conclusion: More Brave Maverick Doctor hagiography

I can't help but note how vague Edwards' and Kruse's testimonials were. There's so little information provided that I have a hard time figuring out what is going on with them (particularly Edwards with his right arm). I do know, however, that their stories fall into the classic format of alternative cancer cure testimonials, complete with their being told to "go home and die" (as many quacks like to characterize what doctors tell patients with incurable cancer), and then finding the Brave Maverick Doctor Burzynski. It sounds very much as though Agu's project will end up being much more hagiography than even reality TV or video. Of course, anyone who pays much attention to reality TV should know by now that reality shows are anything but reality and that most are pretty heavily scripted. At the very least, the contestants or characters are very carefully chosen by the producers to fit the demands of the show, whatever they are, humor, conflict, entertainment, or a specific message.

I wish Edward Kruse and Bo Edwards nothing but the best and truly hope that they are the exceptions, rather than the rule, when it comes to Burzynski patients. I also hope that Burzynski doesn't bankrupt them both before their cancers recur or advance. As for Uchenna Agu, I would urge him to read all the stories on The Other Burzynski Patient Group and to read up about Burzynski's abuses of clinical trial ethics and selling of cancer quackery for 40 years right here. Maybe he's not beyond hope, even if KHOU-TV in Houston appears to be beyond hope when it comes to shilling for Burzynski. The producers of Great Day Houston and the management of the station should know better, given that they're in the same city as he is. Unfortunately, in Texas, Burzynski has juice."

https://www.medpagetoday.com/publichealthpolicy/ethics/76358
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sunspotter sunspotter 1 year ago
And this is worth a read too:

https://theotherburzynskipatientgroup.wordpress.com/
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sunspotter sunspotter 1 year ago
Burzynski likes to steal money raised by the families and friends of sick kids in order to fund his lavish lifestyle. He finds a few new victims - often in Europe - every year.

When your beloved child is dying from a sadly incurable disease, you will clutch at any straw. And charlatans like Burzynski are happy to provide that straw.

These are the situations that Stanislaw Burzynski- may he die in agony and rot in hell as soon as possible - exploits.
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BJ2018 BJ2018 2 years ago
Nagasdog you still here? Anything new going on with this stock?
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sunspotter sunspotter 2 years ago
Burzynski likes to steal money raised by the families and friends of sick kids in order to fund his lavish lifestyle. He finds a few new victims - often in Europe - every year.

When your beloved child is dying from a sadly incurable disease, you will clutch at any straw. And charlatans like Burzynski are happy to provide that straw.

These are the situations that Stanislaw Burzynski- may he die in agony and rot in hell as soon as possible - exploits.
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sunspotter sunspotter 2 years ago
And this is worth a read too:

https://theotherburzynskipatientgroup.wordpress.com/
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sunspotter sunspotter 2 years ago
And more:

'My Cancer Free Life'? Not So Fast
— Reality docuseries as a commercial for quack doc
by David Gorski, MD, PhD November 15, 2018

When I first encountered Stanislaw Burzynski and the Burzynski Clinic around a decade ago, I didn't know what to make of him. Sure, he seemed quacky, with all the testimonials of miracle cures and the claims that he cured deadly brain cancers, like diffuse intrinsic pontine glioma (DIPG), that conventional oncology could do no more than palliate. Sure, it was rather odd that he had never done a fellowship in oncology or an oncology-related specialty.

However, he was a Polish expat who seemingly was an excellent student. And he did have a brief career as a real cancer researcher at Baylor in the early 1970s. During that time he discovered the treatment for cancer (or so he thought) that led him to abandon Baylor around 1977 and set up a manufacturing facility to produce the treatment, which he had dubbed antineoplastons, and to administer them to patients, even though antineoplastons were not FDA-approved and for which, at best, Burzynski only had some relatively weak in-vitro evidence of anticancer activity, a story I wrote about in detail for Skeptical Inquirer 4 years ago.

Let's just put it this way: more than 40 years later, Burzynski has still failed to produce anything resembling convincing evidence that his antineoplastons are effective against cancer. But that hasn't stopped him from continuing to charge massive "management fees" that can run into the hundreds of thousands of dollars to administer antineoplastons to desperate cancer patients. Neither have multiple investigations by the FDA and the Texas Medical Board (TMB) driven him out of business.

Indeed, the most recent attempt by the Texas Medical Board to shut him down ended a year and a half ago in failure. Despite his having to pay a $360,000 fine and agree to submit to monitoring of his billing practices, to complete a medical ethics course (hilarious!), inform his patients that he owns the pharmacy he requires them to use, and submit his informed consent forms to the TMB for review, he's still out there attracting desperate cancer patients to his clinic. He even has a local TV station, KHOU-TV, running on its morning show Great Day Houston what is basically an advertisement for a new "reality" series called My Cancer Free Life, which is being produced by Uchenna Agu and features at least two Burzynski Clinic patients, Bo Edwards and Douglas Kruse, as testimonials for Burzynski's "miracle cures."

Here is the segment, which aired last week:


I had so many questions as I watch this eight-minute segment on Great Day Houston. Let's dig in, but, before I discuss the segment above in depth, let's first go through a little background regarding Burzynski and the media.

KHOU-TV has a history of promoting Burzynski

The first thing I wanted to know was why a local Houston TV station was promoting Stanislaw Burzynski. I had forgotten about it, but KHOU-TV has a long history of doing puff pieces on the Burzynski Clinic, so much so that Houston Press reporter Craig Malisow has even called them "B-jobs." For instance, here's a story from 2009 entitled "Controversial cancer doc: Proof on the way that urine treatment works." Its tagline? "Every day, cancer patients from all over the U.S. come to Houston for treatment. But some drive right past MD Anderson and head for Dr. Stanislaw Burzynski's clinic." It's a story full of false balance, with Burzynski touting how he's going to show that his antineoplastons work interspersed with a doctor from the MD Anderson Cancer Center saying that there is no evidence that it works. It, too, raised the ire of Malisow, and rightly so. Remember, too, that this was more than 30 years after Burzynski broke away from Baylor and started selling his treatments himself. In 2014, KHOU ran a story about how grateful Stanislaw Burzynski was for having gotten to meet Pope John Paul II in the 1980s and in 1996. Here's an excerpt:

Burzynski was recommended to the Vatican at a time when the Pope was rumored to be sick with colon cancer. The doctor was known for unconventional treatments, which did not involve surgery or chemotherapy.

'The government wasn't too nice for my husband's discovery,' said Dr. Barbara Burzynski, Burzynski's wife.

His treatments called Personalized Cancer Therapy are different from every other doctor. He said they target certain cancer cells to stop them from growing. Government officials and the medical community claimed his methods didn't work or at least, there wasn't any proof they did.

'I was being accused of a variety of things which I did not commit,' he said.

Thankfully the pope did not have cancer. But for his willingness to help, Burzynski was blessed with a medal from John Paul's successor, Pope Benedict XVI, which he feels is a strong endorsement of his techniques.

Yes, this really did happen. Also, let's just say that the Catholic Church or any other religion should not be trusted as a reliable guide to good medicine.

Also in 2014, KHOU-TV ran this nine-minute segment, "Overcoming cancer with the help of Dr. Burzynski," which was actually sponsored by the Burzynski Clinic:

This is pure propaganda, basically a brief infomercial for the Burzynski Clinic, complete with the host blathering about how other cancer centers are now adopting the methods of the Burzynski Clinic. (More on that later, but for now, I'll simply call that claim what it is: Nonsense. For example, Burzynski has basically claimed to have invented precision medicine. He did not.) There wasn't a single bit of misinformation or a single trope in this video segment that I hadn't heard before. In particular, he claims that he has a 50% 5-year survival for brainstem cancers, a claim for which Burzynski has never been able to produce anything resembling convincing evidence. The best evidence he can produce is not that good.

So we know right away that someone high up at KHOU-TV is a believer in Burzynski's quackery. Since 2016, Great Day Houston's producer has been Ralph Garcia, and its executive producer Kathy Richey, which implies it's someone higher up in the station who's interested in seeing pro-Burzynski propaganda aired. One wonders if it's Susan McEldoon, who's been the general manager there since 2007 and will be retiring soon. I couldn't find any evidence, though. Whatever the situation, it's clear that KHOU-TV has a thing for Burzynski. Who knows why or who it is who's responsible?

Who is Uchenna Agu?

I'm guessing that some of my readers recognize the name Uchenna Agu, but I must admit that I had no clue who he was when I first encountered this story. Yes, I was reduced to doing what I always do when I don't recognize a name: I Googled him. It turns out that Agu's fame comes from his appearance with his wife Joyce as contestants for The Amazing Race 7 in 2005 (which they apparently won) and later in The Amazing Race All-Stars in 2007. Since I don't think I've watched even a single episode of that show, I had no idea. In any event, he's also appeared in Push (2014) and Sanitatum (2018). (I know. That didn't help me either.) Apparently, he's now a producer and a managing partner at the consulting agency UEA Group.

As for the production companies involved, I noted a couple of interesting things. The blurbs under the story and on the YouTube page suggests Big or Small Media Entertainment, LLC for more information. Clicking on that link goes to an unclaimed domain and a GoDaddy page. They also mention video from TKGmediaproductions.com, which, it turns out, is owned by someone named Tony Garcia. I can't help but wonder if he's related to producer Ralph Garcia in some way.

My Cancer Free Life? It begins.

So let's get to My Cancer Free Life.

Given that there's minimal, if any, video footage shown in this segment promoting My Cancer Free Life, and I can't find any with my prodigious Googling skills, I couldn't help but wonder how early in production this "reality docuseries" is. Usually, in cases of a producer, director, or actor doing promotional interviews about his project, he'll be able to show at least a little footage. True, there is a brief clip at the beginning of the segment of Stanislaw Burzynski himself going on about how when he started it was the "dark ages of cancer treatment". Whether that was provided by Agu or was stock footage from past KHOU-TV infomercials on Burzynski, I don't know. It wasn't revealed. Ditto on some footage later in the segment of the Burzynski Clinic. I was impressed at how pedestrian it all looked. In any case, Great Day Houston host Deborah Duncan is next up to introduce the segment, which includes Uchenna Agu and the two Burzynski Clinic patients, Doug Kruse and Bo Edwards.

One thing that became apparent right away is that, unlike a lot of Burzynski Clinic patients, Kruse and Edwards maintain a low social media and Internet profile. Searches for their names plus "cancer" and/or "Stanislaw Burzynski" failed to turn up much other than this segment. Ironically, it turns out that Kruse once did comment on a blog that might be familiar to many of you on a post entitled How is it that in 2018 cancer Stanislaw Burzynski is still preying on desperate cancer patients? (Update). The date of the comment is August 6, 2018:

Dear Doctor. I say again....Hello! I came to Burzynski clinic March 2017 with stage 4 prostate cancer and kidney carcinoma. I responded well to treatment and returned to work at the office in December. This week my CT PET scan results are good and we are concluding treatment. I find several of the comments above blatantly false based on my experiences in being treated meeting with Dr. Burzynski about once a week for over a year. And, I have met in our IV room several who have recovered when standard of care was to go home and die, too. That includes one gentleman from Canada that go over pancreatic cancer as I observed week to week as a co-patient. I have spent the monthly cost for investment and am happy with the results noted. Request: Would you please increase the respectful part of your dialogue? Including complying with your own guidelines for comments and eliminating some of the abusive vocabulary, please. Respectfully, Douglas Kruse Jr. Houston, TX.


Clearly, there's not much in this comment to help me understand his testimonial other than that Mr. Kruse has stage IV prostate cancer and kidney cancer. It's not clear if he has both prostate and kidney cancer (which would be very unusual) or prostate cancer that's metastasized to the kidney (less uncommon). I'll discuss him more later on based on what he says on this KHOU-TV segment. As for Bo Edwards, I could find basically nothing about him other than links to the KHOU-TV segment. Searches on Facebook and Twitter didn't yield anything either. It's almost as though these patients were chosen for how little information about them is publicly available on Facebook, Twitter, YouTube, and various websites, even pro-Burzynski websites.

My Cancer Free Life? The propaganda is thick.

After we see Burzynski's smiling face going on about how the sequencing of the human genome was the milestone that revolutionized cancer treatment, Great Day Houston host Deborah Duncan reads an introduction that will make anyone familiar with Stanislaw Burzynski's four-decade scam cringe, so much so that I wondered if Burzynski himself had written it. She basically recounts that Burzynski discovered a gene-targeted cancer therapy back in the 1970s. This is, of course, ridiculous. Contrary to the hagiography of Eric Merola's two propaganda movies about Burzynski, Burzynski The Movie: Cancer Is A Serious Business and Burzynski: Cancer Is A Serious Business, Part II, in which it is claimed that Burzynski is a pioneer of "gene-targeted cancer therapy," Burzynski's two go-to treatments include the unproven and likely ineffective (antineoplastons) and the "make it up as you go along" (his "gene-targeted therapy").

Particularly risible have been Burzynski's arrogant, ego-fueled claims (mindlessly repeated on this segment) that he first described "gene-targeted therapy" and that he invented precision oncology, with major cancer centers like MD Anderson only now catching up to his vision. (I first saw this claim in Suzanne Somer's quackfest of a book, Knockout: Interviews With Doctors Who Are Curing Cancer And How To Prevent Getting It in the First Place.) It's a message parroted both by Duncan and Agu in this segment, and it's simply not true. Burzynski is not a "pioneer" in personalized gene-targeted cancer therapy and never has been. He is most definitely not a pioneer in immunotherapy either, contrary to Agu's assertion. That the segment starts out with a message painting Burzynski as a scientist ahead of his time tells me that what I'm seeing is propaganda far more than journalism and that Agu's docuseries will apparently preach this message tells me that Agu is more akin to Eric Merola than to a serious producer, at least when it comes to Burzynski. Let's just put it this way. If Burzynski had never been born, major cancer centers would be embracing precision medicine and immunotherapy now in exactly the same way, mainly because Burzynski has had zero positive effect on oncology.

When the camera pans out to show all the guests for the first time, my first reaction upon seeing Bo Edwards was that he looks very, very sick. Inexplicably, his whole right arm is bandaged and he has a catheter in place that is hooked up to a black bag that he's carrying. It makes me wonder if he's getting a continuous infusion of antineoplastons. In any event, he looks gaunt, and there's something funny about how his loose shirt sits on his bandaged right arm. Certainly, he does not look the way that Agu describes him (and Kruse), "cured of cancer."

In any event, we learn from Bo Edwards that the reason he went to the Burzynski Clinic after being diagnosed with stage IV cancer (type not yet specified) was because a friend of his wife with stage IV cancer (type not specified) had gone there 18 years ago and was cured. In any event, he was told that he could have chemotherapy (which probably wouldn't work); he could have radiation (which would likely only prolong his life marginally); or he could have radical surgery that would involve removing his arm, shoulder, and part of his upper chest. When I heard this, all I could think of was forequarter amputation, the same operation recommended to Jessica Ainscough, whose promotion of "holistic health" and alternative medicine led her to be known in Australia as the Wellness Warrior. She ultimately died of her disease after a very prolonged course, but what had frightened her from conventional treatment was the prospect of a forequarter amputation, a brutal operation that is rarely performed these days. Seeing Edwards' bandaged arm and hearing the recommendation that he have what sure sounded like a forequarter amputation, made me wonder if he has what Ainscough had, epithelioid sarcoma. In any event, the fact that he was offered such radical surgery suggested to me that he has some sort of sarcoma involving his upper arm and that he doesn't have metastases to distant organs. If he did, there's no way such radical surgery would even be considered.

So when was Bo Edwards diagnosed? It turns out that it wasn't that long ago. He was given the three options, according to his story, in January 2018, only 9 months ago. That's an awfully short time to be declared cured of any cancer. We're also shown zero evidence that Edwards is, in fact, cancer-free, as he claims. If he were cancer-free, I wonder, why is his arm bandaged and why is he still hooked up to an infusion device? As Edwards finished telling his story, I couldn't help but feel a wave of sorrow and empathy for him. He really believes he's been cured, and I hope he is, but everything about his story suggests otherwise and that he's just been fortunate thus far. I also couldn't help but notice that the Great Day Houston bug always seemed to be sitting over Edwards' other arm, where the infusion catheter was inserted under a bandage.

Mr. Kruse recounted his story next, and it was much as what you read in his comment cited above. He was diagnosed in March 2017. According to him, his wife took him to the emergency room then because his "system shut down," and he had high blood pressure. From the sound of it, he had prostate cancer metastatic to kidney and bone. He added that he was told that he should just go home and grieve with his family. Now, I suppose that's entirely possible, but it sounds a bit hard to believe. For one thing, prostate cancer, even metastatic prostate cancer, tends to be a slow-growing disease; it's not that surprising that someone with stage IV prostate cancer could be alive a year and a half after diagnosis. For another thing, treatments for prostate cancer have improved markedly since I was in medical school and residency. At a decent cancer hospital (and, let's not forget that M. Anderson is located in Houston), a patient with stage IV prostate cancer will be told that his disease is indeed incurable, but won't just be punted home as Edwards described. He'll be told that we have treatments that can slow down the progression of the disease and that he could have years left.

In fairness, I don't know the full extent of Kruse's disease. He didn't say, either in the blog comment above or on this segment on KHOU-TV. However, whenever I hear a story like his I wonder whether there was a misunderstanding of his prognosis or whether he went to a crappy hospital that doesn't do a lot of oncology. Again, I have no way of knowing from what I see here. In any event, Kruse's wife and daughter persuaded him to go to the Burzynski Clinic.

What does Burzynski do differently?

The final part of the segment began with Duncan asking Agu, "What does Dr. Burzynski do differently?" The answer told me just how deep the propaganda will be in this docuseries. I also wasn't too thrilled to see Agu invoke "right-to-try." After all, right-to-try is a scam designed to weaken the FDA, and Burzynski has been using it to get around the FDA. Agu then says that there is a DNA test that each patient must take before getting into the Burzynski Clinic, and "if you fall within that window, you're golden." At this point, I was shaking my head and wondering just what the heck Agu was talking about. He seemed to be implying that there was a small "window of opportunity" during which a patient can benefit from Burzynski's treatments. Given that Burzynski appears to specialize in extracting cash from patients who have advanced cancer, this statement makes little sense.

Duncan also pitched another slow, hanging ball right over the plate by asking, "Why isn't every treatment facility doing it this way?" If I were on the show, I'd have answered that the reason is simple. Burzynski has never shown anything resembling compelling evidence that his approach works better than what we do now -- or even that it works at all. Agu, of course, regurgitated an answer right out of the quackery defense league's manual about how cancer doctors have developed a "standard way" of treating cancer over the years such that "everyone is 'this is the way we do it' and it doesn't open the door to alternative treatment." In other words, it's the same old' same old'. Doctors are too close-minded. Doctors can't tolerate the competition. Doctors won't try anything different. He then went on to say that doctors should be referring to Burzynski "on the front end" after a DNA test to see if the patient "fits" (whatever that means).

Apparently, the docuseries won't just be about Burzynski, either, although clearly, it looks as though Burzynski will be a major focus. Agu says he'll also look at patients who have chosen conventional therapy and other alternative therapies. Anyone want to guess how well the ones who choose conventional therapy will do? I'm sure the selection will not be random. After all, Edwards and Kruse were given the opportunity to have almost the last word, which they took to go on about how Burzynski's given them hope. Unfortunately, I know otherwise. I know Burzynski. I've examined more testimonials by patients of his than I can remember, many of them analyzed right here on this blog. My friend Bob Blaskiewicz, who runs The Other Burzynski Patient Group, has done likewise. Basically, Burzynski's patients all pay tens or hundreds of thousands of dollars to be treated, often under sham clinical trials designed solely to let Burzynski avoid FDA actions. There is no good evidence that they do better than they would have done without Burzynski.

Conclusion: More Brave Maverick Doctor hagiography

I can't help but note how vague Edwards' and Kruse's testimonials were. There's so little information provided that I have a hard time figuring out what is going on with them (particularly Edwards with his right arm). I do know, however, that their stories fall into the classic format of alternative cancer cure testimonials, complete with their being told to "go home and die" (as many quacks like to characterize what doctors tell patients with incurable cancer), and then finding the Brave Maverick Doctor Burzynski. It sounds very much as though Agu's project will end up being much more hagiography than even reality TV or video. Of course, anyone who pays much attention to reality TV should know by now that reality shows are anything but reality and that most are pretty heavily scripted. At the very least, the contestants or characters are very carefully chosen by the producers to fit the demands of the show, whatever they are, humor, conflict, entertainment, or a specific message.

I wish Edward Kruse and Bo Edwards nothing but the best and truly hope that they are the exceptions, rather than the rule, when it comes to Burzynski patients. I also hope that Burzynski doesn't bankrupt them both before their cancers recur or advance. As for Uchenna Agu, I would urge him to read all the stories on The Other Burzynski Patient Group and to read up about Burzynski's abuses of clinical trial ethics and selling of cancer quackery for 40 years right here. Maybe he's not beyond hope, even if KHOU-TV in Houston appears to be beyond hope when it comes to shilling for Burzynski. The producers of Great Day Houston and the management of the station should know better, given that they're in the same city as he is. Unfortunately, in Texas, Burzynski has juice."

https://www.medpagetoday.com/publichealthpolicy/ethics/76358
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sunspotter sunspotter 2 years ago
More on the sick scamster that is Stanislaw Burzynski:

"It’s been a while since I wrote a substantive post for this blog about the Houston cancer doctor and Polish expat Stanislaw Burzynski who claims to have a fantastic treatment for cancer that blows away conventional treatment for cancers that are currently incurable. The time has come—and not for good reasons. The last time was primarily just a post announcing my article about Burzynski being published in Skeptical Inquirer. When last we saw Stanislaw Burzynski on this blog, it was a post that I hated to write, in which I noted that the Food and Drug Administration (FDA) had caved to patient and legislator pressure and allowed compassionate use exemptions (otherwise known as single patient INDs) to continue. The catch? Cynically, the FDA put a condition on its decision, specifically that no doctor associated with Burzynski nor Burzynski himself could administer the antineoplastons. This set off a mad scramble among Burzynski patients wanting ANPs to find a doctor willing to do all the paperwork and deal with Burzynski to administer ANPs. The family of one patient, McKenzie Lowe, managed to succeed.

It’s hard for me to believe that it’s been almost three years since I first started taking an interest in Burzynski. Three long years, but that’s less than one-twelfth the time that Burzynski has been actually been administering an unproven cancer treatment known as antineoplastons (ANPs), a drug that has not been FDA-approved, to patients, which he began doing in 1977. Yes, back when Burzynski got started administering ANPs to patients, I was just entering high school, the Internet as we know it did not exist yet (just a much smaller precursor), and disco ruled the music charts. It’s even harder for me to believe, given the way that Burzynski abuses clinical trial ethics and science, that I hadn’t paid much attention to him much earlier in my blogging career. After all, I’m a cancer surgeon, and here’s been this guy treating patients with advanced brain cancers using peptides that, according to Burzynski, do so much better against what are now incurable tumors than standard of care while charging huge sums of money to patients on “clinical trials.” It might be a cliché to quote the Dead this way, but what a long, strange trip it’s been. Because there has been a major development in this saga whose context you need to know to understand, I’m going to do a brief recap. Long-time regulars, feel free to skip the next couple of paragraphs, as they just try to bring people up to date and include a lot of links for background, or, if you haven’t already, read this summary of Burzynski’s history published earlier this year in Skeptical Inquirer. Newbies, listen up. Read the next two paragraphs. You need to know this to understand why I’m so unhappy.

Incidents that I never blogged about here (but fortunately a certain “friend” of mine did on another blog) that have occurred since the FDA caved and (sort of) lifted the partial clinical hold on ANPs included:

For the first time in 37 years, Burzynski published what was purported to be the complete results of one of his phase I/II clinical trials. The results were—shall we say?—underwhelming.
Before that Burzynski had published 42.5% of one of his phase I/II trials, with even more unconvincing results.
Meanwhile, since he received that warning letter from the FDA late last year, in addition to making unconvincing claims excusing the issues described in the FDA warning letter, he’s been trying to enlist patients, both cute children and the semi-famous, to persuade legislators to pressure the FDA to let his clinical trials open again after they had been put on a partial clinical hold in the wake of the death of a child from hypernatremia (too much sodium in the blood), as reported by Liz Szabo in USA TODAY. All the while Burzynski has continued to charge patients large sums of money, while bragging that he didn’t charge for the actual ANPs. For those unfamiliar with the story, a partial clinical hold means that Stanislaw Burzynski can’t enroll any new patients on clinical trial but can continue to treat patients already enrolled.

Yes, three months ago—has it been that long already?—I noted with dismay that, under the onslaught of sympathetic cancer patients who understandably but incorrectly believe that Burzynski is their last chance to live, the FDA did indeed cave, although in the most weaselly way imaginable, stating that Stanislaw Burzynski could again enroll patients under compassionate use exemptions (also known as single patient INDs), even though the FDA warning letter had found gross deficiencies in the Burzynski Research Institute Institutional Review Board (BRI-IRB), which is run by an old crony of Burzynski’s who just so happens to be chair of the board of directors of the BRI and was found to be negligent in protecting patients by playing fast and loose with the regulations for enrolling patients on single patient INDs. The condition was that Burzynski himself or anyone working for him couldn’t be the physician treating the patients, leaving the patients to find a doctor willing to oversee the administration of ANPs.

And so it was for three months, with desperate patients with terminal brain tumors scrambling to find some doctor willing to do the paperwork to get the FDA to allow him to administer ANPs and also willing to work with such a disreputable character. McKenzie Lowe’s family, for instance, managed to find a retired family practitioner named Terry Bennett to agree to this. (More on this later.) Then, last week, this bombshell landed, courtesy of Liz Szabo again, in a story entitled “FDA gives controversial doc green light to restart work“:

The Food and Drug Administration has given a controversial Houston doctor the green light to resume administering experimental cancer treatments.

The FDA has lifted restrictions on a clinical trial run by Stanislaw Burzynski, who was the subject of a USA TODAY investigation last year. Burzynski, 70, has wrangled with state and federal medical authorities for nearly 40 years over his claims that he has discovered natural substances that can fight certain cancers.

You might think that my reaction upon reading this would be “WTF?” It wasn’t. However, that was only because I had had that reaction a week ago, when I read a press release from the BRI, “Burzynski Research Institute, Inc. Announces Lifting Of The FDA Partial Clinical Hold – Phase 3 Clinical Study Agreed Upon“:

The Burzynski Research Institute, Inc. (BRI) announced today that U.S. Food and Drug Administration (FDA) has notified the company that its partial clinical hold on its IND for Antineoplastons A10/AS2-1 Injections has been lifted. The FDA has determined that under its IND the Company may initiate its planned Phase 3 study in newly diagnosed diffuse, intrinsic, brainstem glioma. The Company is continuing discussions with the Agency in an effort to finalize additional details of the phase 3 study protocol for the potential clinical trial.

The FDA’s decision to lift the clinical hold marks an important step in the development of Antineoplastons for the treatment of various forms of brain tumors in the US. At the same time, the Company is evaluating possible next steps for the Antineoplastons clinical program given the current progress and anticipated resource requirements of the ongoing program.

That was when I had my “WTF?” moment. However, noting the obviously intentionally vague language of the press release, I decided to wait until I could learn more and obtain confirmation rather than to blog the press release. For one thing, Burzynski could have just been spinning furiously, and there could have been a lot less to this press release than met the eye. It wouldn’t be the first time. Also, I just couldn’t believe that the FDA would so horrifically fail patients with brain cancer yet again the way it now has. I could sort of see why the FDA issued its previous ruling that allowed other doctors to enroll patients in single patient INDs of ANPs. At the time, the FDA was under a lot of pressure from legislators being contacted by constituents about families in their state or district with brain cancer who wanted to be treated by Burzynski. Its cynical solution must have seemed downright Solmonic at the time to the administrators who thought of it. But this? There’s nothing in the press release that says that the conditions that led to the partial clinical hold were resolved. Yesterday, however, there was this in Szabo’s story:

In a statement issued Wednesday), the FDA confirmed that it has lifted its restrictions on Burzynski because he answered all of their questions. In particular, Burzynski addressed “common and serious (and in some cases fatal) adverse drug reactions, as well as accurate information on how often tumors shrink after treatment with antineoplastons.”

Notice something missing? I did. The FDA said nothing about the BRI-IRB, which was soundly chastised for approving single patient INDs without full meetings of the committee. It also said nothing about the massive conflicts of interest that exist in the IRB and how it can’t possibly be independent. Sure, if Burzynski talked the talk adequately, I might see how the FDA might be either snowed or too tired to fight any more. I could see how it might be tempted to let him open his bogus clinical trials again—but only if Burzynski were forced to use a truly independent IRB, not his crony-packed IRB that basically rubber stamps whatever it is he wants to do with no questions and no evident effort to protect the welfare and rights of clinical trial subjects. Any IRB worth its salt will refuse to approve a clinical trial now and then and/or issue warnings to principal investigators for inadequate documentation, too many adverse events, etc. Has the BRI-IRB ever done this? Not as far as anyone I know can tell. Of course, it’s not really up to the FDA to oversee the function of IRBs. Rather, it’s more a function of the Office of Human Research Protections (OHRP). Long have I wondered: Where the heck has the OHRP been all these years?

It’s not as though Burzynski isn’t up to his old tricks again, either. Even with another physician overseeing the treatment of McKenzie Lowe, he’s managing to find ways to charge patients huge sums of money, even as he isn’t charging them for the ANPs. Indeed, the other day, Dr. Bennett, the physician who is overseeing the treatment of McKenzie Lowe whom I mentioned near the beginning of this article, was featured in an article in a local newspaper “Dr. feels misled in cancer treatment costs“. The money quotes are here:

But there was something Bennett didn’t know.

Bennett’s decision was based, in part, on a newspaper article that said Burzynski had agreed to donate the medicine required for McKenzie’s treatment. But what Bennett didn’t know is that Burzynki [sic] planned to charge the family for the clinical costs associated with the therapy.

LaFountain said the first month’s bill is expected to be $28,000. Every month after that is expected to cost $16,000. The treatment usually lasts eight to 12 months.

And health insurance won’t cover a dime of it.

And here:

Bennett says a representative of the Burzynski Clinic called him on that date seeking payment for the first month of McKenzie’s therapy. Prior to that, Bennett, who is donating his services, thought Burzynski was doing the same.

Instead, said Bennett, “I’m supposed to be the bag man for all of this. They want me to collect the 30 grand for the family and send it to Burzynski.”

Elsewhere, Bennett said, “It [the Burzynski Clinic] meets all the criteria for a bait and switch operation.” Yes, even Dr. Bennett found out the hard way how the Burzynski Clinic operates. None of this is anything new. Burzynski has been trying to dodge this tactic for years by saying that he doesn’t charge patients for his actual drug, the ANPs, giving the impression that he’s not charging them much of anything. However, the reality is that costs can rapidly add up to hundreds of thousands of dollars, which is why fundraisers by families of Burzynski patients have been a feature surrounding the Burzynski Clinic operation for decades, as has been documented time and time and time again.

This is a doctor who wants to help and is willing to take risks, even if inappropriately in this case, and he feels used by Burzynski. Indeed, his comparing himself to a “bag man” is a particularly apt metaphor, because that’s what he is in this: A bag man. It’s his job to collect the cash from the family of a dying child and ship it to Burzynski. Ironically, this news story appeared on the very same day as Burzynski’s press release, and, of course, Szabo’s story appeared yesterday. Did the FDA know Burzynski was doing this? It strains credulity to think that the FDA didn’t know about this abuse of a desperately ill child’s family, given that information regarding how it will be paid for is part of a single patient IND application, indeed part of all clinical trial applications. Indeed, that Burzynski gets away with this is yet more evidence that his IRB is nothing more than a rubber stamp, because any independent IRB would ask some very hard questions about such an arrangement. Very hard questions indeed. It’s painfully obvious that the BRI-IRB has never asked hard questions any IRB should be asking about any clinical trial Burzynski has proposed or about how his clinical trials are being carried out.

It’s even worse than that, though. Check out what I found on a website devoted to penny stocks, “Burzynski Research Institute (BZYR) Reignites On FDA Approaval” [sic]:

Focusing since 1967 on the isolation of various biochemicals produced by the human body as part of the body’s possible defense against cancer, the penny stock of Burzynski Research Institute, Inc. (BZYR) has exploded on the scene thanks to the efforts of CEO and President Stanislaw R. Burzynski, M.D., Ph.D. After notification that the U.S. Food and Drug Administration lifted its partial clinical hold on its IND for Antineoplastons A10/AS2-1 Injections, shares of BZYR stock begun to trade and are putting on a good show thus far. Although only around 25 million shares issued and outstanding do not belong to the founder who is determined to treat of various forms of brain tumors, the large jump upwards has made this little biotech burz-worthy.

You know, with all the typos and English that sounds as though it were written by someone who isn’t a native English speaker, this made me suspicious that Burzynski or someone from Burzynski’s clinic wrote it. Either that, or the web page is written by non-English speakers, which seems likely given that I found the same sorts of weird-sounding sentence constructions in other articles and I know Burzynski’s people can produce serviceable English prose when they need to. Be that as it may, I have little doubt that the Burzynski clinic is trying to take advantage of the FDA decision to bolster its flagging finances, which have been reportedly hurting since the partial clinical hold was placed. Whether this article on a website hawking penny stocks has anything to do with it, I don’t know, but its appearance right around this time sure doesn’t seem coincidental to me.

So what happened? Why did the FDA cave so ignominiously? How could it ignore 37 years of Burzynski’s therapeutic misadventures and abuse of science and the clinical trial process? I have a few ideas, but none of them are satisfying, and all of them are speculation, ranging from educated to, well, just speculation. Back in the 1990s, it was powerful legislators like Joe Barton leaning on the FDA to let Burzynski be Burzynski. Today, there are no visible and obvious champions in Congress for Burzynski. Even so, that doesn’t necessarily mean that such congressional patrons don’t exist, given the campaign waged by patient families and the Burzynski clinic to get people to write their Congressmen and Senators. Another likely possibility is that the FDA is just tired. If it shuts Burzynski down, it will be portrayed for years as the bad guy denying patients a chance at life, and there will be an enormous court battle. If it decides to fight, the FDA could end up with years of litigation, and, given the FDA’s unfortunately limited budget, it has to pick its battles. Does it help the FDA’s mission overall if it drains so many resources fighting what it likely views as small fry like Burzynski that it finds late in the fiscal year that it can’t afford to go after a large drug company over lack of resources? I don’t know, but given how long Burzynski’s been at it, the FDA’s decision is still an extreme dereliction of its duty to the public.

Whatever the reason that the FDA caved, we’ll probably never know. We can make FOIA requests, but the FDA is notoriously tight with the information it permits to be releases because it’s forbidden from releasing information that might endanger trade secrets of the companies it regulates and it appears to take a fairly expansive view of what constitutes such information. At least, we’ll probably never know unless we can get a powerful Senator or Congressman (or two) interested and as outraged as we skeptics are. A Congressional investigation, as unlikely as that sounds, is probably the only thing that will get to the bottom of the FDA’s utter failure. It’s clear that in this case the FDA is no longer able or willing to protect the safety, finances, or rights of patients with advanced cancer."

https://sciencebasedmedicine.org/stanislaw-burzynskis-propaganda-victory-on-antineoplastons-the-fda-really-caves/
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sunspotter sunspotter 2 years ago
Worth repeating:

"Stanislaw Burzynski’s propaganda victory on antineoplastons: The FDA caves Posted by David Gorski on March 24, 2014 Mark Crislip, founder of the Society for Science-Based Medicine, whose board of directors I’m proud to be serving on, an organization that you should join if you haven’t already, sometimes jokes that our logo should be an image of Sisyphus, the king of Ephyra whom Zeus punished by compelling him to roll an immense boulder up a hill. However, the boulder was enchanted and, as soon as Sisyphus reached the top, it would roll back down the hill. Sisyphus was thus forced to repeat this action throughout all eternity. The metaphor is obvious. Those of us who try to combat quackery and the infiltration of pseudoscience in medicine often feel a lot like Sisyphus. I always used to argue that, as amusing as it might be to have such a logo as an “in” joke, it’s far too much of a downer to inspire what SSBM wants to inspire: Action in the form of volunteers taking on projects, such as converting Quackwatch into a wiki and then continuously updating and adding to that wiki indefinitely. We have to believe that there is hope of someday succeeding. “Let’s push that boulder up a hill one more time!” does not exactly constitute an inspiring rally cry, although I can definitely understand the feeling at times the older I get and the longer I’ve been doing this. We can all appreciate gallows humor at times, and, besides, I’m not that pessimistic. I can’t afford to be. Even so, I can understand the Sisyphus analogy right now with respect to an unfortunately frequent subject of this blog, the doctor in Houston who proclaims himself a cancer doctor, even though he has no formal training in medical oncology, isn’t even board-certified in internal medicine, the prerequisite for undertaking advanced training in medical oncology, and has no discernable training in clinical trials management. I’m referring, of course, to Stanislaw Burzynski, MD, PhD, the Polish doctor who since 1977 has been treating patients with substances that he has dubbed “antineoplastons” (ANPs). What are ANPs? Burzynski claimed to have discovered ANPs during his time at Baylor and described them as endogenous cancer-fighting chemicals in human blood and urine. Unfortunately, he soon became convinced that only he could develop them into an effective chemotherapy drug and left Baylor to administer ANPs to his own cancer patients. Patients flocked to him because he claimed to be able to cure cancers that conventional medicine can’t cure. This led to a series of battles between Burzynski and various authorities, including the Texas Medical Board, the FDA, and various attorneys general, because of his use of ANPs, which are not and never have been FDA approved, as well as for various—shall we say?—issues with insurance companies. Ultimately, in the 1990s Burzynski beat the rap and effectively neutered the FDA’s case against him by submitting dozens of clinical trials to the FDA for approval, which, given how much pressure the FDA was under from Burzynski’s friends in high places (like Texas Representative Joe Barton), the FDA ended up approving. However, as Burzynski’s lawyer himself bragged, these clinical trials were shams designed to allow Burzynski to keep treating cancer patients, not clinical trials designed to produce any real evidence of efficacy. Not surprisingly, although Burzynski has published the odd case report or tiny case series, he has not yet published the full results of even a single one of his many phase II trials. There is, quite simply, no convincing evidence that ANPs have significant antitumor activity in vivo in humans, even after 37 years. Meanwhile, the FDA has found numerous examples of Burzynski’s abuse of clinical trials, failure to keep necessary data, and failure to protect human subjects, while exposés by BBC Panorama and Liz Szabo at USA TODAY have been most unflattering, revealing at least one dead child as a result of the toxicity of Burzynski’s drug and a pattern of minimizing and hiding reports of adverse reactions. I had at least two other ideas for what I thought would be informative, entertaining, and timely posts, but then late last week I found out about a new development in Burzynski’s latest battle to try to use patients as weapons again to bring pressure to bear on the FDA (as he did in the 1990s) to allow patients with brain tumors to be treated with ANPs under single patient INDs, also known as compassionate use exemptions or expanded access programs. Such exemptions allow some patients who have no good conventional options access to unapproved investigational agents. Ironically, one of the most damning findings about the Burzynski Research Institute and Burzynski Clinic from the FDA investigation last year was how Burzynski would play fast and loose with the rules regarding approval by the institutional review board (IRB) of such exemptions. IRBs are committees mandated by the Office for Human Research Protections (OHRP) to protect human research subjects by approving and monitoring clinical trials to make sure that patients are not placed at undue risk, that proper informed consent is given, and that clinical trials conform to all ethical and legal requirements. Let’s just put it this way. The FDA caved. You’ll see what I mean shortly. Worse, it caved in a way that basically abdicated its responsibility. Those of you who read my not-so-super-secret other blog will realize that I’ve already begun the discussion over there, making part of this post repetitive. However, there have been new developments over the weekend, and I very much want a record of this abdication of duty by the FDA on this blog as well—in more detail, of course. “Just when I thought I was out, they pull me back in.” Sadly, the brief little quote from Michael Corleone (as played by Al Pacino) in The Godfather, Part III, basically sums up my feelings with respect to Stanislaw Burzynski. Every time I think that I can give the topic a rest for a while (and, believe me, I do want to give it a rest), something invariably seems to happen to pull me back in. So it was Thursday evening, when I was made aware of a new development so disappointing that I’m still wiping the dirt off my chin from my jaw dropping to the floor. Even more amazing is that my disappointment stems from my perception of cynicism that actually was not Burzynski’s, but rather by the FDA in response to Burzynski’s cynical use of cancer patients as shields and weapons against the FDA that has led some of us who support science-based medicine to be subjected to criticism from the families of patients with cancer, who have been erroneously convinced that Stanislaw Burzynski is their loved ones’ last chance to survive. Actually, I can’t tell if it’s a cynical move or a breathtakingly naïve move, but it’s a huge mistake regardless, as you’ll see. I’m guessing that some will think of it as a very clever move, and so it is, but it’s a cleverness we could use less of. About a year ago, Burzynski was once again investigated by the FDA. Because of the death of a patient due to hypernatremia (elevated sodium level) due to ANPs in 2012, the FDA put a partial clinical hold on his pediatric clinical trials and extended it to all of his clinical trials. What this means is that, although Burzynski can continue to treat patients who are already in his clinical trials, he can’t enroll any new patients in them. Of course, one of the big issues with Burzynski that contributed to his problems is that he abused the FDA process known as the single patient IND, which is more commonly known as the compassionate use exemption. These are special case exemptions in which a single patient is allowed access to an investigational agent outside the auspices of a clinical trial. Indeed, when the FDA slapped him down most recently, in December, one of its findings was just that: Burzynski abused the single patient IND process and his institutional review board (IRB), the committee that’s supposed to oversee clinical trials and safeguard the interests and safety of clinical trial subjects, played fast and loose with the rules. Since the appearance of a USA TODAY story by Liz Szabo spelling out all of these issues, Burzynski has been frantically trying to save his empire. Whether “encouraged” by Burzynski or just by one of the patient groups that have become true believers, patients with deadly cancer have been starting petitions, pressuring legislators to intercede on their behalf to the FDA, and paint Burzynski’s ANPs as their only hope of survival. I have no doubt that these patients believe it, but they have the potential to inadvertently do great mischief to the law, either through their use of their tragic stories to promote misguided “right to try” laws or through their use of patient stories to pressure the FDA to loosen protections on human subjects in clinical trials. Perhaps the most tragic story is that of Rafael Elisha Cohen, a six-year-old child with medullablastoma who is not doing well and whose parents have been at the forefront of pressuring the FDA. As horrible as the Cohens’ situation is—and we all understand that it’s a horrible, horrible thing to have a child dying of brain cancer—unfortunately, the FDA appears to have decided to cave. The other day, on a Facebook page dedicated to raising money and pressuring the FDA, Devorah Teicher Cohen announced: UPDATE- Thanks to everyones hard work the FDA did end up approving the Antineoplastins for compassionate use – they do not let Dr B administer it. The condition is, if an oncologist request this protocol FDA will issue compassionate use within 24 Hours. FDA recognizes the data of those who survived aggressive brain tumors due to the ANP and is therefor after a long and cruel wasting TIME period allowing it. There are currently 8 pediatric patients that need this medicine NOW!!!! Refael Elisha can not travel at this point…so we would need an oncologist in the NY area… we are in touch with other kids that are ready to get on a plain if they get the signal of a cooperating oncologist. It is beyond words to express our sadness that FDA ended approving the drug but Elisha is in critical condition at the moment. We are not holding our breath and are trying different alternatives , If HASHEM wills it we will get the medicine but if not, that is from Hashem for the good. in the meantime Please put your fillers out there and message me in privet if you have any leads , even if not in NY it might work out for the other desperate children. im copying the announcement from ANP site Wanted: One brave courageous oncologist or oncologists willing to examine and treat up to eight pediatric brain cancer patients who have run out of treatment options and now require a Compassionate Use IND Emergency Treatment protocol from the U.S. Food and Drug Administration. The ANP Coalition needs your help now. Please visit www.anpcoalition.org or call (925) 699-9116. Thank You When I first saw this message on the Prayers for Elisha Facebook page, I was cautious. I could find confirmation of this news nowhere else, not even on the ANP Coalition webpage. Then, on Friday afternoon, Liz Szabo, the USA TODAY reporter who previously published her epic expose of the Burzynski cancer machine back in November, basically confirmed the report with a followup story in USA TODAY, FDA agrees to let patients get controversial drug: The Food and Drug Administration has agreed to allow a handful of cancer patients to receive unapproved drugs from a controversial Texas doctor, but only if they can find another physician to administer them. The drugs are made by Houston doctor Stanislaw Burzynski, who was the subject of a USA TODAY investigation last year. While his supporters consider him a medical maverick, mainstream doctors describe him as a snake-oil salesman. Burzynski has claimed for more than 36 years to be able to cure certain hard-to-treat brain tumors with drugs he calls antineoplastons. The National Cancer Institute notes that Burzynski has never published definitive evidence that his drugs cure cancer or even help people live longer. Burzynski has been unable to give these drugs since 2013, when the FDA placed his experiments on hold after the death of a 6-year-old New Jersey boy taking antineoplastons. In December, the FDA sent Burzynski a warning letter, noting that he inflated his success rates and failed to report side effects and to prevent patients from repeatedly overdosing. The Texas Medical Board also charged Burzynski last year with false advertising. None of this stopped the FDA from caving: The FDA acknowledged Friday that it has agreed to allow them to use the experimental drug, but only if they can find a qualified, independent physician to administer the drug. Beyond infusing the drug and overseeing their care, the doctor would have to formally apply for expanded access to an “investigational new drug,” as well as get approval from an institutional review board, an independent panel that reviews safety and ethical issues involved in clinical trials. Can anyone figure out why I can’t make up my mind whether this decision, if what the Cohens say is true, is stunningly cynical or stunningly naïve on the part of the FDA? Instead of standing firm for science and gently continuing to point out that it can’t allow any more single patient INDs for ANPs be approved based on science, Burzynski’s past violations of FDA regulations, and, above all, the need to follow the FDA’s mandate and mission to protect vulnerable cancer patients, instead the FDA has dangled more false hope of a single-patient IND in front of Elisha’s family (and the eight other children petitioning for such INDs). It’s hard to believe that the FDA is not aware that it is incredibly unlikely that any reputable pediatric oncologist would agree to administer ANPs under these conditions, given Burzynski’s reputation. In a way, what the FDA is doing inadvertently compounds the families’ agony. Now they have hope again, except that this time it’s doubly false: False because, based on existing evidence and what we know now, ANPs almost certainly don’t work and false because of how incredibly unlikely it is that any pediatric oncologist will take on such a patient and administer ANPs, given Burzynski’s history, the utter lack of supporting science for the efficacy of ANPs, and the not-inconsiderable amount of work and expense that would be necessary in order to do so. The families will now be showing up in the offices of pediatric oncologists, begging them to agree to do a single patient IND and administer ANPs to these patients. Ditto some adult oncologists. Indeed, according to Szabo’s report, Liza Covad-Lauser, wife of rock star Sammy Hagar’s drummer David Lauser, claims that she has already found a doctor willing to administer the antineoplastons. One wonders if this doctor knows what he is getting himself into. As cynical as it might sound of me to say so, I can’t help but wonder whether being the wife of a member of a rock star’s band, who can garner signatures on petitions by other rock stars, has an effect. Here’s why the FDA’s action is doubly cynical (or nave). As alluded to in Szabo’s article, according to FDA regulations, there are a number of requirements for a single patient IND and several things any physician seeking to administer an investigational agent as a single patient IND must do. Here’s the most important one that makes it even more unlikely that any single patient IND will be granted, except for perhaps briefly as an “emergency exemption” in which IRB approval can be briefly deferred: 5. Informed Consent Statement that states that informed consent and approval of the use by an appropriate Institutional Review Board (IRB) will be obtained prior to initiating treatment. In the case of an emergency, treatment may begin without prior IRB approval, provided the IRB is notified of the emergency treatment within 5 working days of treatment. See what I mean? Even if a family were to find an oncologist willing to jump through all the hoops to get a patient on a single patient IND to be treated with ANPs, that single patient IND would still have to be approved by the IRB of the institution where that oncologist practices. Sure, the oncologist could declare the treatment an “emergency”—although in none of the cases that I’m aware of other than that of Elisha Cohen could be properly termed an emergency so urgent that the physician couldn’t wait a week or two to have the IRB formally discuss the IND, even if ANPs actually did have any efficacy—and start treatment pending IRB approval, but as soon as the IRB convened to discuss the IND, very likely the plug would be pulled. No more ANPs. Remember, these would be real IRBs, not Stanislaw Burzynski’s sham IRB chaired by an old crony of his. There’s another question to consider. Stanislaw Burzynski routinely used to treat some of these patients for free, supplying ANPs for no cost and waiving case management fees. No doubt this offer was primarily for publicity, to blunt the accusation that, based on the exorbitant amounts of money charged to previous patients, Burzynski is in it for the money. So, not surprisingly, according to Szabo’s report, Burzynski is still offering to provide the drug for free. That’s all well and good, but it leaves all the other expenses of treatment, which will not be paid for by insurance because ANPs are not an FDA-approved drug. Who’s going to pay for all of that? While it is true that some of the families have raised quite a bit of money (Elisha’s family, for instance, has raised nearly $150,000), others aren’t so lucky. A massive Burzynski propaganda victory? Supporters of Stanislaw Burzynski wasted no time in using the FDA decision to defend Burzynski and, ironically, to attack the FDA. Many of you might remember McKenzie Lowe, the 12-year-old girl diagnosed with diffuse intrinsic pontine glioma (DIPG) in 2012. Her family has been trying to have her treated by Stanislaw Burzynski, making videos and lobbying Congress. Indeed, they succeeded in persuading their senator, Senator Kelly Ayotte (R-NH), to write to the FDA urging it to consider allowing McKenzie to be treated by Burzynski. On a Facebook page Friends of McKenzie Lowe, a message was posted on Sunday simultaneously rejoicing at the news as evidence that McKenzie has a chance to live and lambasting Liz Szabo: As you all probably have read in the USA Today the FDA has agreed to let Mckenzie and the other people who want to use ANP CAN USE IT!!!! FANTASTIC!!!!! But as you can see the writer of the article is very bias on the negative side. As usual she one again took something good for these patients and in stead of focusing on the positive response from the FDA she took another swing at bashing Dr. Burzynski and his clinic. There was no mention of or comments from Anthony Stout, Rick Schiff, Jessica Ressel, Randy Hinton, Philip Norton and many many more.. Let’s go back in history to all the nay Sayers that said Christopher Columbus was crazy. The world is flat, you will fall off the end. Hmmm. Einstein was a quack… Hmmm. Isaac Newton and Galileo were also shunned by their peers… Thank god they had the fortitude to push aside the nay sayers and continue to prove them ALL wrong. Imagine where we would ALL be today if they had listened to their critics and not persevered with what they believed. Unfortunately, this is known as the Galileo Gambit, a nice, concise term used to argue that if you are vilified for your ideas it must mean that you are right. Unfortunately, what supporters of pseudoscientists and quacks frequently forget is that there are two requirements necessary to be able to credibly claim the mantle of Galileo. Not only must you be vilified, but you must be correct. Only one of these applies to Stanislaw Burzynski, and it isn’t the second one. As has been the case whenever I’ve discussed patients like McKenzie Lowe, Liza Covad-Hauser, Rafael Elisha Cohen, and others, I understand, at least as much as it is possible to understand without actually being in their shoes. As I’ve pointed out before, it was only five years ago that my mother-in-law died of widely-metastatic breast cancer. Burzynski couldn’t have saved her. ANPs couldn’t have saved her. And I know I’m going to take some flak for saying this, but ANPs cannot save McKenzie Lowe. At least, there is no convincing evidence that they can, and, quite frankly, the only blame for why this is true should be placed at the feet of Stanislaw Burzynski himself. He’s the one who, thinking himself the “brave maverick doctor” to whom the rules of science don’t apply, has failed to produce such evidence. While I understand the desperation these families are feeling, I keep hoping that they will realize that it is not doing McKenzie, Elisha, or any of the others any favors to subject them to toxic chemotherapy—and, make no mistake, ANPs are toxic chemotherapy, efforts of advocates to paint them as “natural” and “nontoxic” notwithstanding. As I’ve pointed out time and time again: If there’s anything worse than dying of a terminal illness, it’s dying of a terminal illness and suffering unnecessary complications or pain for no benefit in the process. I can totally understand why families like the Lowes might become very excited about the possibility of being able to use ANPs. As misled as they have been and mistaken as their belief is, they do, after all, genuinely believe that ANPs represent the last chance their loved ones have to be able to survive their cancer. Unfortunately, our old “friend” and Burzynski’s very own propagandist, Eric Merola, who has produced two fawning “documentaries” about the Great Man chock full of misinformation and exaggerations, coupled with attacks on Burzynski critics and skeptics, has no such excuse and deserves none of the compassion that we should all have for patients dying of brain tumors and the families who love them. Not surprisingly, he, too, has leapt into the fray with a typically frothing-at-the-mouth conspiracy-laden pile of fetid dingos’ kidneys of a response to Liz Szabo’s story, in which he examines it line-by-line and basically responds with typical Burzynski propaganda, misinformation and lies. There’s too much there for a full response in this post. Besides, most of the misinformation that’s there I’ve covered before, often multiple times. Perhaps I’ll respond a bit more on my not-so-super-secret other blog. Here, I simply want to point out a few of the most egregious examples. For example, here is probably the most egregious lie on Merola’s part: A DIPG in a child has never been cured in medical history — why would the FDA make such a claim in this case? It’s quite simple, the science proved it works and cures in many cases, and therefore the science was allowed to progress. There are no “claims” other than what can be proven. Maybe it’s because the cancer industry doesn’t like anyone else “claiming” anything as they own the luxury of claiming what cancer medications work or not work — and we know how well that has worked out for us. As I’ve pointed out before, this is, quite simply, untrue. It’s also been pointed out time and time again to Merola that this is untrue. Long-term survival for patients with DIPG is rare, definitely, but it’s always dangerous to make an absolute statement like the one that Merola has done. Contrary to Burzynski’s claim, there are occasional long-term survivors, some of whom received little or no therapy, such Connor Frankenberg, a child from Germany, and two patients who underwent spontaneous remission. There is even a site, the DIPG Registry, whose purpose is reporting on how patients with DIPG do and promoting Just One More Day, a registered non-profit 501(c)(3) organization dedicated to helping families affected by a diffuse intrinsic pontine glioma, established by the families of DIPG victims. The DIPG Registry concludes that, although the vast majority of children with DIPGs do poorly: The bottom line is: 1) we really don’t understand DIPGs, and 2) there are children who have been diagnosed with DIPGs-based on the incomplete knowledge that we currently have- who truly have had spontaneous regression of their tumors and 3) most of the children with reports of spontaneous regression have been very young. Young like Tori Moreno, I might add. The big problem is that Burzynski appears not to keep good enough records to demonstrate one way or the other whether he can cure DIPG, and we already know from recent FDA findings and Liz Szabo’s USA TODAY report that he has misclassified partial and complete responses. Yes, DIPG is a horrible disease, with only 10% surviving beyond two years. Unfortunately, there is no convincing evidence that Burzynski can do any better than conventional oncology, much less cure DIPG, as much as his propagandist Eric Merola repeats the claim that he can. Worse, Burzynski hasn’t published a single one of his completed phase II clinical trials, even though he’s had well over 15 years to complete them. With tumors this lethal, most such trials should be completed within five years, which brings us to more of Merola’s misinformation: The National Cancer Institute notes that Burzynski has never published definitive evidence that his drugs cure cancer or even help people live longer. The above links are examples definitive published evidence. Notice how this writer links to a PDF highlighting her point, vs. the National Cancer Institute (NCI) website itself. Is it perhaps because on the NCI website it clearly says: “A phase II study also conducted by the developer [Burzynski] and his associates at his clinic reported on 12 patients with recurrent and diffuse intrinsic brain stem glioma. Of the ten patients who were evaluable, two achieved complete tumor response, three had partial tumor response, three had stable disease, and two had progressive disease. Patients ranged in age from 4 to 29 years.” The NCI felt its own source to be “definitive enough”, why not Liz? *Source: www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page5#Reference5.12 Merola clearly does not understand the difference between “responses” and cures. Similarly, he does not understand what constitutes “definitive evidence.” (Hint: It isn’t case reports, tiny case series published in bottom-feeding journals, or incomplete phase II trials. Moreover, just because the NCI cited a crappy review article by Burzynski that reported partial results phase II trials, a ten year old partial report of a phase II trial, a dubious paper published in an integrative medicine journal, and another review article published by Burzynski in a journal that appears not to be even indexed by PubMed does not constitute “definitive evidence” that ANPs work. All it means is that the NCI was examining the existing published evidence on its way to writing this: To date, no randomized controlled trials examining the use of antineoplastons in patients with cancer have been reported in the literature. Existing published data have taken the form of case reports or series, phase I clinical trials, and phase II clinical trials, conducted mainly by the developer of the therapy and his associates. While these publications have reported successful remissions with the use of antineoplastons, other investigators have been unable to duplicate these results [10] and suggest that interpreting effects of antineoplaston treatment in patients with recurrent gliomas may be confounded by pre-antineoplaston treatment and imaging artifacts.[11,14,16] Reports originating from Japan on the effect of antineoplaston treatment on brain and other types of tumors have been mixed, and in some Japanese studies the specific antineoplastons used are not named.[9] In many of the reported studies, several or all patients received concurrent or recent radiation therapy, chemotherapy, or both, confounding interpretability. Mr. Merola, that’s hardly “definitive”! Nor is the “definitive” study by Hidaeki Tsuda featured in the second Burzynski movie, given that nothing has been published to allow us to evaluate the methods. Nor is the fact that The Lancet Oncology apparently editorially rejected a manuscript submitted by Burzynski evidence of any sort of “conspiracy” against him. Indeed, I now probably know why Burzynski’s manuscript was rejected. Look at the title: “Glioblastoma multiforme: A report of long-term progression-free and overall survival of 8 to over 16 years after antineoplaston therapy and a review of the literature”. Yes, the title seems to indicate that this is just another small case series. No wonder The Lancet Oncology didn’t even bother to send it out for review! Of course, Merola can’t resist a swipe at yours truly, who was quoted in the article: A guy who is paid to write blogs attacking this innovation and other innovations that compete with the status quo, a guy who has never once met a Burzynski patient, never once visited the Burzynski clinic, a guy who supposedly finished his residency and now writes “thought police” blogs for a living — yeah, let’s hear more about what this guy has to say, that’s productive. He does fit the angle for Liz’s one-sided propaganda, so I understand why she included his irrelevant opinion. I don’t know whether to laugh or be annoyed at Merola’s continued lies about me. Once again, I do not need to visit the Burzynski Clinic to know that ANPs almost certainly don’t work. I did finish my residency and am board certified in surgery. If Mr. Merola doesn’t believe that, he can go to the American Board of Surgery website and search for my name in the section that lets the public verify the board certification of surgeons, realizing that you can’t become board certified without finishing an accredited residency. Finally, I don’t actually blog for a living. It’s my hobby. I’m not paid at all for my work at SBM, and at my not-so-super-secret other blog I make a small amount of money that I could completely do without if that gig ever went south or I decided to bolt. As for having something worthwhile to say, well, let’s just say that I’d put my record for science-based analysis against Mr. Merola’s record for pseudoscience-based propaganda any day, particularly in light of his latest paean to another brave maverick, this time promoting the long-discredited cancer quackery known as laetrile. At least Merola included a link to my page on SBM. He seems to think it’s something nefarious, while I’m more than happy to include a link to it here. Please, read. Why did the FDA cave? What is puzzling to me is why the FDA caved. While it is true that the ANP Coalition managed to get a few misguided legislators, the most prominent of whom was Senator Kelly Ayotte (R-NH), to write letters to the FDA urging that it consider allowing ANPs to be made available through single patient IND/expanded access to their constituents, the letters were fairly wishy-washy. Moreover, the Change.gov petition to the White House response to a We The People online petition to have the FDA allow Elisha Cohen access to ANPs through compassionate use exemption resulted in a response that, boiled down to it essence, said that it’s the FDA’s job to make such decisions, and let the FDA do its job, along with links to various FDA web pages with information about investigational drugs and information about how the FDA could be contacted. It was a shockingly reasonable response. One rationale reported in Szabo’s article seems to be that by allowing ANPs to be used but excluding Burzynski from having anything to do with administering them other than producing them, in essence, relegating him to the role of a drug manufacturer, useful data might be obtained and patients protected while obtaining that useful data. This is utter nonsense. As Howard Ozer is quoted in Szabo’s article: “This is a cop-out,” says Ozer, director of the University of Illinois Cancer Center, who studied Burzynski’s research results in the 1990s. “Because it can be toxic and cause life-threatening sodium problems, patients (who take antineoplastons) are at risk and could die,” Ozer says. The scientific community will learn nothing by giving these patients antineoplastons, because there will be no comparison group, Ozer says. Any doctor who agrees to give antineoplastons could be biased in favor of them, which could skew the results. Exactly. As Dr. Peter Adamson points out in the article, after 37 years, if antineoplastons were the wonder drugs that Burzynski claims them to be, scientists would know it by now. ANPs aren’t wonder drugs. There isn’t even any evidence that they’re better than standard-of-care, as dismal as that is for DIPG. It is possible that one of the Senators or other legislators did indeed pressure the FDA, leading the relevant enforcement officials to come up with this decision in order to get them off their backs without actually doing anything. They could credibly say, “Hey, we offered compassionate use, but I’m sure you’ll agree that, given his history, we can’t let Burzynski be the one to administer the ANPs on compassionate use. Look at his history of playing fast and loose with IRBs and not obeying the rules with respect to INDs.” This might even sound convincing and seem clever, which is why I rather suspect that Dr. Henry Friedman is right when he says: “It will deflect criticism from anybody who says the FDA is unilaterally denying dying patients something that could help them,” says Friedman, deputy director of the Preston Robert Tisch Brain Tumor Center at Duke University in North Carolina, who also reviewed Burzynski’s studies in the 1990s. “It will get FDA off the hook.” That, I believe, is exactly why the FDA did it, not to help dying children. Unfortunately, the consequences of the FDA’s decision are likely to be disastrous. Long-suffering families will have false hope extended to them once again, only to find out that it’s a useless offer. In addition to continuing to scramble to raise money, they’ll scramble to find oncologists willing to do the not-inconsiderable work to get a single-patient IND approved and administer ANPs, something few, if any of them, are likely to succeed at. The families don’t know it yet, but what the FDA has done will only add to their misery. Indeed, I’ve already seen reports that patients have contacted “dozens” of pediatric oncologists looking for one who will administer ANPs, and, given that the number of pediatric oncologists in the US is small, a significant proportion of them are likely to be contacted. Meanwhile, Burzynski gets a propaganda victory, thanks to the FDA’s failure to enforce its own standards, and alt-med proponents get another conspiracy theory to add to the list of conspiracy theories surrounding Burzynski already." http://www.sciencebasedmedicine.org/stanislaw-burzynskis-propaganda-victory-on-antineoplastons-the-fda-caves/
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sunspotter sunspotter 2 years ago
You just “invested” in America’s most disgusting scam.

Burzynski steals from desperate cancer patients, their relatives and friends.

Frankly he should be imprisoned for life, and I’m only being that charitable because I oppose the death penalty.
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Iapetus Iapetus 2 years ago
I've just invested in the stock because after 30 years, the FDA and their bosses in Big Pharma haven't been able to stop him as they have done others in history. Harry Hoxey and Royal Rife are two examples. Hoxey actually won his case in California against the AMA because so many people came to testify that they had been cured of cancer, including a U.S. Senator' son who himself had been cured. Rife who cured 16 out of 16 cancer patients in a trial, was "accidentally" given the wrong drug while himself been hospitalized for a minor heart condition.

They've tried and failed to prosecute him several times and it's all well documented. Go to the website: https://www.canuexplain.com/news/proven-cancer-cure-by-dr-burzynski-in-fda-cover-up/

Remember if it didn't work, they would have long ago been able to prosecute him because he had been openly treating people and still is in his trials. He just made it past Phase II and is headed for Phase III.

If people don't realize how stacked the deck is by big pharma, the AMA and the government, you're just not willing to look at the plethora of evidence. I think there are at least 12 books on Fraudci's corrupt activities alone. One book says he the most powerful and dangerous bureaucrat in armeican history.
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sunspotter sunspotter 4 years ago
"Stanislaw Burzynski’s propaganda victory on antineoplastons: The FDA caves Posted by David Gorski on March 24, 2014 Mark Crislip, founder of the Society for Science-Based Medicine, whose board of directors I’m proud to be serving on, an organization that you should join if you haven’t already, sometimes jokes that our logo should be an image of Sisyphus, the king of Ephyra whom Zeus punished by compelling him to roll an immense boulder up a hill. However, the boulder was enchanted and, as soon as Sisyphus reached the top, it would roll back down the hill. Sisyphus was thus forced to repeat this action throughout all eternity. The metaphor is obvious. Those of us who try to combat quackery and the infiltration of pseudoscience in medicine often feel a lot like Sisyphus. I always used to argue that, as amusing as it might be to have such a logo as an “in” joke, it’s far too much of a downer to inspire what SSBM wants to inspire: Action in the form of volunteers taking on projects, such as converting Quackwatch into a wiki and then continuously updating and adding to that wiki indefinitely. We have to believe that there is hope of someday succeeding. “Let’s push that boulder up a hill one more time!” does not exactly constitute an inspiring rally cry, although I can definitely understand the feeling at times the older I get and the longer I’ve been doing this. We can all appreciate gallows humor at times, and, besides, I’m not that pessimistic. I can’t afford to be. Even so, I can understand the Sisyphus analogy right now with respect to an unfortunately frequent subject of this blog, the doctor in Houston who proclaims himself a cancer doctor, even though he has no formal training in medical oncology, isn’t even board-certified in internal medicine, the prerequisite for undertaking advanced training in medical oncology, and has no discernable training in clinical trials management. I’m referring, of course, to Stanislaw Burzynski, MD, PhD, the Polish doctor who since 1977 has been treating patients with substances that he has dubbed “antineoplastons” (ANPs). What are ANPs? Burzynski claimed to have discovered ANPs during his time at Baylor and described them as endogenous cancer-fighting chemicals in human blood and urine. Unfortunately, he soon became convinced that only he could develop them into an effective chemotherapy drug and left Baylor to administer ANPs to his own cancer patients. Patients flocked to him because he claimed to be able to cure cancers that conventional medicine can’t cure. This led to a series of battles between Burzynski and various authorities, including the Texas Medical Board, the FDA, and various attorneys general, because of his use of ANPs, which are not and never have been FDA approved, as well as for various—shall we say?—issues with insurance companies. Ultimately, in the 1990s Burzynski beat the rap and effectively neutered the FDA’s case against him by submitting dozens of clinical trials to the FDA for approval, which, given how much pressure the FDA was under from Burzynski’s friends in high places (like Texas Representative Joe Barton), the FDA ended up approving. However, as Burzynski’s lawyer himself bragged, these clinical trials were shams designed to allow Burzynski to keep treating cancer patients, not clinical trials designed to produce any real evidence of efficacy. Not surprisingly, although Burzynski has published the odd case report or tiny case series, he has not yet published the full results of even a single one of his many phase II trials. There is, quite simply, no convincing evidence that ANPs have significant antitumor activity in vivo in humans, even after 37 years. Meanwhile, the FDA has found numerous examples of Burzynski’s abuse of clinical trials, failure to keep necessary data, and failure to protect human subjects, while exposés by BBC Panorama and Liz Szabo at USA TODAY have been most unflattering, revealing at least one dead child as a result of the toxicity of Burzynski’s drug and a pattern of minimizing and hiding reports of adverse reactions. I had at least two other ideas for what I thought would be informative, entertaining, and timely posts, but then late last week I found out about a new development in Burzynski’s latest battle to try to use patients as weapons again to bring pressure to bear on the FDA (as he did in the 1990s) to allow patients with brain tumors to be treated with ANPs under single patient INDs, also known as compassionate use exemptions or expanded access programs. Such exemptions allow some patients who have no good conventional options access to unapproved investigational agents. Ironically, one of the most damning findings about the Burzynski Research Institute and Burzynski Clinic from the FDA investigation last year was how Burzynski would play fast and loose with the rules regarding approval by the institutional review board (IRB) of such exemptions. IRBs are committees mandated by the Office for Human Research Protections (OHRP) to protect human research subjects by approving and monitoring clinical trials to make sure that patients are not placed at undue risk, that proper informed consent is given, and that clinical trials conform to all ethical and legal requirements. Let’s just put it this way. The FDA caved. You’ll see what I mean shortly. Worse, it caved in a way that basically abdicated its responsibility. Those of you who read my not-so-super-secret other blog will realize that I’ve already begun the discussion over there, making part of this post repetitive. However, there have been new developments over the weekend, and I very much want a record of this abdication of duty by the FDA on this blog as well—in more detail, of course. “Just when I thought I was out, they pull me back in.” Sadly, the brief little quote from Michael Corleone (as played by Al Pacino) in The Godfather, Part III, basically sums up my feelings with respect to Stanislaw Burzynski. Every time I think that I can give the topic a rest for a while (and, believe me, I do want to give it a rest), something invariably seems to happen to pull me back in. So it was Thursday evening, when I was made aware of a new development so disappointing that I’m still wiping the dirt off my chin from my jaw dropping to the floor. Even more amazing is that my disappointment stems from my perception of cynicism that actually was not Burzynski’s, but rather by the FDA in response to Burzynski’s cynical use of cancer patients as shields and weapons against the FDA that has led some of us who support science-based medicine to be subjected to criticism from the families of patients with cancer, who have been erroneously convinced that Stanislaw Burzynski is their loved ones’ last chance to survive. Actually, I can’t tell if it’s a cynical move or a breathtakingly naïve move, but it’s a huge mistake regardless, as you’ll see. I’m guessing that some will think of it as a very clever move, and so it is, but it’s a cleverness we could use less of. About a year ago, Burzynski was once again investigated by the FDA. Because of the death of a patient due to hypernatremia (elevated sodium level) due to ANPs in 2012, the FDA put a partial clinical hold on his pediatric clinical trials and extended it to all of his clinical trials. What this means is that, although Burzynski can continue to treat patients who are already in his clinical trials, he can’t enroll any new patients in them. Of course, one of the big issues with Burzynski that contributed to his problems is that he abused the FDA process known as the single patient IND, which is more commonly known as the compassionate use exemption. These are special case exemptions in which a single patient is allowed access to an investigational agent outside the auspices of a clinical trial. Indeed, when the FDA slapped him down most recently, in December, one of its findings was just that: Burzynski abused the single patient IND process and his institutional review board (IRB), the committee that’s supposed to oversee clinical trials and safeguard the interests and safety of clinical trial subjects, played fast and loose with the rules. Since the appearance of a USA TODAY story by Liz Szabo spelling out all of these issues, Burzynski has been frantically trying to save his empire. Whether “encouraged” by Burzynski or just by one of the patient groups that have become true believers, patients with deadly cancer have been starting petitions, pressuring legislators to intercede on their behalf to the FDA, and paint Burzynski’s ANPs as their only hope of survival. I have no doubt that these patients believe it, but they have the potential to inadvertently do great mischief to the law, either through their use of their tragic stories to promote misguided “right to try” laws or through their use of patient stories to pressure the FDA to loosen protections on human subjects in clinical trials. Perhaps the most tragic story is that of Rafael Elisha Cohen, a six-year-old child with medullablastoma who is not doing well and whose parents have been at the forefront of pressuring the FDA. As horrible as the Cohens’ situation is—and we all understand that it’s a horrible, horrible thing to have a child dying of brain cancer—unfortunately, the FDA appears to have decided to cave. The other day, on a Facebook page dedicated to raising money and pressuring the FDA, Devorah Teicher Cohen announced: UPDATE- Thanks to everyones hard work the FDA did end up approving the Antineoplastins for compassionate use – they do not let Dr B administer it. The condition is, if an oncologist request this protocol FDA will issue compassionate use within 24 Hours. FDA recognizes the data of those who survived aggressive brain tumors due to the ANP and is therefor after a long and cruel wasting TIME period allowing it. There are currently 8 pediatric patients that need this medicine NOW!!!! Refael Elisha can not travel at this point…so we would need an oncologist in the NY area… we are in touch with other kids that are ready to get on a plain if they get the signal of a cooperating oncologist. It is beyond words to express our sadness that FDA ended approving the drug but Elisha is in critical condition at the moment. We are not holding our breath and are trying different alternatives , If HASHEM wills it we will get the medicine but if not, that is from Hashem for the good. in the meantime Please put your fillers out there and message me in privet if you have any leads , even if not in NY it might work out for the other desperate children. im copying the announcement from ANP site Wanted: One brave courageous oncologist or oncologists willing to examine and treat up to eight pediatric brain cancer patients who have run out of treatment options and now require a Compassionate Use IND Emergency Treatment protocol from the U.S. Food and Drug Administration. The ANP Coalition needs your help now. Please visit www.anpcoalition.org or call (925) 699-9116. Thank You When I first saw this message on the Prayers for Elisha Facebook page, I was cautious. I could find confirmation of this news nowhere else, not even on the ANP Coalition webpage. Then, on Friday afternoon, Liz Szabo, the USA TODAY reporter who previously published her epic expose of the Burzynski cancer machine back in November, basically confirmed the report with a followup story in USA TODAY, FDA agrees to let patients get controversial drug: The Food and Drug Administration has agreed to allow a handful of cancer patients to receive unapproved drugs from a controversial Texas doctor, but only if they can find another physician to administer them. The drugs are made by Houston doctor Stanislaw Burzynski, who was the subject of a USA TODAY investigation last year. While his supporters consider him a medical maverick, mainstream doctors describe him as a snake-oil salesman. Burzynski has claimed for more than 36 years to be able to cure certain hard-to-treat brain tumors with drugs he calls antineoplastons. The National Cancer Institute notes that Burzynski has never published definitive evidence that his drugs cure cancer or even help people live longer. Burzynski has been unable to give these drugs since 2013, when the FDA placed his experiments on hold after the death of a 6-year-old New Jersey boy taking antineoplastons. In December, the FDA sent Burzynski a warning letter, noting that he inflated his success rates and failed to report side effects and to prevent patients from repeatedly overdosing. The Texas Medical Board also charged Burzynski last year with false advertising. None of this stopped the FDA from caving: The FDA acknowledged Friday that it has agreed to allow them to use the experimental drug, but only if they can find a qualified, independent physician to administer the drug. Beyond infusing the drug and overseeing their care, the doctor would have to formally apply for expanded access to an “investigational new drug,” as well as get approval from an institutional review board, an independent panel that reviews safety and ethical issues involved in clinical trials. Can anyone figure out why I can’t make up my mind whether this decision, if what the Cohens say is true, is stunningly cynical or stunningly naïve on the part of the FDA? Instead of standing firm for science and gently continuing to point out that it can’t allow any more single patient INDs for ANPs be approved based on science, Burzynski’s past violations of FDA regulations, and, above all, the need to follow the FDA’s mandate and mission to protect vulnerable cancer patients, instead the FDA has dangled more false hope of a single-patient IND in front of Elisha’s family (and the eight other children petitioning for such INDs). It’s hard to believe that the FDA is not aware that it is incredibly unlikely that any reputable pediatric oncologist would agree to administer ANPs under these conditions, given Burzynski’s reputation. In a way, what the FDA is doing inadvertently compounds the families’ agony. Now they have hope again, except that this time it’s doubly false: False because, based on existing evidence and what we know now, ANPs almost certainly don’t work and false because of how incredibly unlikely it is that any pediatric oncologist will take on such a patient and administer ANPs, given Burzynski’s history, the utter lack of supporting science for the efficacy of ANPs, and the not-inconsiderable amount of work and expense that would be necessary in order to do so. The families will now be showing up in the offices of pediatric oncologists, begging them to agree to do a single patient IND and administer ANPs to these patients. Ditto some adult oncologists. Indeed, according to Szabo’s report, Liza Covad-Lauser, wife of rock star Sammy Hagar’s drummer David Lauser, claims that she has already found a doctor willing to administer the antineoplastons. One wonders if this doctor knows what he is getting himself into. As cynical as it might sound of me to say so, I can’t help but wonder whether being the wife of a member of a rock star’s band, who can garner signatures on petitions by other rock stars, has an effect. Here’s why the FDA’s action is doubly cynical (or nave). As alluded to in Szabo’s article, according to FDA regulations, there are a number of requirements for a single patient IND and several things any physician seeking to administer an investigational agent as a single patient IND must do. Here’s the most important one that makes it even more unlikely that any single patient IND will be granted, except for perhaps briefly as an “emergency exemption” in which IRB approval can be briefly deferred: 5. Informed Consent Statement that states that informed consent and approval of the use by an appropriate Institutional Review Board (IRB) will be obtained prior to initiating treatment. In the case of an emergency, treatment may begin without prior IRB approval, provided the IRB is notified of the emergency treatment within 5 working days of treatment. See what I mean? Even if a family were to find an oncologist willing to jump through all the hoops to get a patient on a single patient IND to be treated with ANPs, that single patient IND would still have to be approved by the IRB of the institution where that oncologist practices. Sure, the oncologist could declare the treatment an “emergency”—although in none of the cases that I’m aware of other than that of Elisha Cohen could be properly termed an emergency so urgent that the physician couldn’t wait a week or two to have the IRB formally discuss the IND, even if ANPs actually did have any efficacy—and start treatment pending IRB approval, but as soon as the IRB convened to discuss the IND, very likely the plug would be pulled. No more ANPs. Remember, these would be real IRBs, not Stanislaw Burzynski’s sham IRB chaired by an old crony of his. There’s another question to consider. Stanislaw Burzynski routinely used to treat some of these patients for free, supplying ANPs for no cost and waiving case management fees. No doubt this offer was primarily for publicity, to blunt the accusation that, based on the exorbitant amounts of money charged to previous patients, Burzynski is in it for the money. So, not surprisingly, according to Szabo’s report, Burzynski is still offering to provide the drug for free. That’s all well and good, but it leaves all the other expenses of treatment, which will not be paid for by insurance because ANPs are not an FDA-approved drug. Who’s going to pay for all of that? While it is true that some of the families have raised quite a bit of money (Elisha’s family, for instance, has raised nearly $150,000), others aren’t so lucky. A massive Burzynski propaganda victory? Supporters of Stanislaw Burzynski wasted no time in using the FDA decision to defend Burzynski and, ironically, to attack the FDA. Many of you might remember McKenzie Lowe, the 12-year-old girl diagnosed with diffuse intrinsic pontine glioma (DIPG) in 2012. Her family has been trying to have her treated by Stanislaw Burzynski, making videos and lobbying Congress. Indeed, they succeeded in persuading their senator, Senator Kelly Ayotte (R-NH), to write to the FDA urging it to consider allowing McKenzie to be treated by Burzynski. On a Facebook page Friends of McKenzie Lowe, a message was posted on Sunday simultaneously rejoicing at the news as evidence that McKenzie has a chance to live and lambasting Liz Szabo: As you all probably have read in the USA Today the FDA has agreed to let Mckenzie and the other people who want to use ANP CAN USE IT!!!! FANTASTIC!!!!! But as you can see the writer of the article is very bias on the negative side. As usual she one again took something good for these patients and in stead of focusing on the positive response from the FDA she took another swing at bashing Dr. Burzynski and his clinic. There was no mention of or comments from Anthony Stout, Rick Schiff, Jessica Ressel, Randy Hinton, Philip Norton and many many more.. Let’s go back in history to all the nay Sayers that said Christopher Columbus was crazy. The world is flat, you will fall off the end. Hmmm. Einstein was a quack… Hmmm. Isaac Newton and Galileo were also shunned by their peers… Thank god they had the fortitude to push aside the nay sayers and continue to prove them ALL wrong. Imagine where we would ALL be today if they had listened to their critics and not persevered with what they believed. Unfortunately, this is known as the Galileo Gambit, a nice, concise term used to argue that if you are vilified for your ideas it must mean that you are right. Unfortunately, what supporters of pseudoscientists and quacks frequently forget is that there are two requirements necessary to be able to credibly claim the mantle of Galileo. Not only must you be vilified, but you must be correct. Only one of these applies to Stanislaw Burzynski, and it isn’t the second one. As has been the case whenever I’ve discussed patients like McKenzie Lowe, Liza Covad-Hauser, Rafael Elisha Cohen, and others, I understand, at least as much as it is possible to understand without actually being in their shoes. As I’ve pointed out before, it was only five years ago that my mother-in-law died of widely-metastatic breast cancer. Burzynski couldn’t have saved her. ANPs couldn’t have saved her. And I know I’m going to take some flak for saying this, but ANPs cannot save McKenzie Lowe. At least, there is no convincing evidence that they can, and, quite frankly, the only blame for why this is true should be placed at the feet of Stanislaw Burzynski himself. He’s the one who, thinking himself the “brave maverick doctor” to whom the rules of science don’t apply, has failed to produce such evidence. While I understand the desperation these families are feeling, I keep hoping that they will realize that it is not doing McKenzie, Elisha, or any of the others any favors to subject them to toxic chemotherapy—and, make no mistake, ANPs are toxic chemotherapy, efforts of advocates to paint them as “natural” and “nontoxic” notwithstanding. As I’ve pointed out time and time again: If there’s anything worse than dying of a terminal illness, it’s dying of a terminal illness and suffering unnecessary complications or pain for no benefit in the process. I can totally understand why families like the Lowes might become very excited about the possibility of being able to use ANPs. As misled as they have been and mistaken as their belief is, they do, after all, genuinely believe that ANPs represent the last chance their loved ones have to be able to survive their cancer. Unfortunately, our old “friend” and Burzynski’s very own propagandist, Eric Merola, who has produced two fawning “documentaries” about the Great Man chock full of misinformation and exaggerations, coupled with attacks on Burzynski critics and skeptics, has no such excuse and deserves none of the compassion that we should all have for patients dying of brain tumors and the families who love them. Not surprisingly, he, too, has leapt into the fray with a typically frothing-at-the-mouth conspiracy-laden pile of fetid dingos’ kidneys of a response to Liz Szabo’s story, in which he examines it line-by-line and basically responds with typical Burzynski propaganda, misinformation and lies. There’s too much there for a full response in this post. Besides, most of the misinformation that’s there I’ve covered before, often multiple times. Perhaps I’ll respond a bit more on my not-so-super-secret other blog. Here, I simply want to point out a few of the most egregious examples. For example, here is probably the most egregious lie on Merola’s part: A DIPG in a child has never been cured in medical history — why would the FDA make such a claim in this case? It’s quite simple, the science proved it works and cures in many cases, and therefore the science was allowed to progress. There are no “claims” other than what can be proven. Maybe it’s because the cancer industry doesn’t like anyone else “claiming” anything as they own the luxury of claiming what cancer medications work or not work — and we know how well that has worked out for us. As I’ve pointed out before, this is, quite simply, untrue. It’s also been pointed out time and time again to Merola that this is untrue. Long-term survival for patients with DIPG is rare, definitely, but it’s always dangerous to make an absolute statement like the one that Merola has done. Contrary to Burzynski’s claim, there are occasional long-term survivors, some of whom received little or no therapy, such Connor Frankenberg, a child from Germany, and two patients who underwent spontaneous remission. There is even a site, the DIPG Registry, whose purpose is reporting on how patients with DIPG do and promoting Just One More Day, a registered non-profit 501(c)(3) organization dedicated to helping families affected by a diffuse intrinsic pontine glioma, established by the families of DIPG victims. The DIPG Registry concludes that, although the vast majority of children with DIPGs do poorly: The bottom line is: 1) we really don’t understand DIPGs, and 2) there are children who have been diagnosed with DIPGs-based on the incomplete knowledge that we currently have- who truly have had spontaneous regression of their tumors and 3) most of the children with reports of spontaneous regression have been very young. Young like Tori Moreno, I might add. The big problem is that Burzynski appears not to keep good enough records to demonstrate one way or the other whether he can cure DIPG, and we already know from recent FDA findings and Liz Szabo’s USA TODAY report that he has misclassified partial and complete responses. Yes, DIPG is a horrible disease, with only 10% surviving beyond two years. Unfortunately, there is no convincing evidence that Burzynski can do any better than conventional oncology, much less cure DIPG, as much as his propagandist Eric Merola repeats the claim that he can. Worse, Burzynski hasn’t published a single one of his completed phase II clinical trials, even though he’s had well over 15 years to complete them. With tumors this lethal, most such trials should be completed within five years, which brings us to more of Merola’s misinformation: The National Cancer Institute notes that Burzynski has never published definitive evidence that his drugs cure cancer or even help people live longer. The above links are examples definitive published evidence. Notice how this writer links to a PDF highlighting her point, vs. the National Cancer Institute (NCI) website itself. Is it perhaps because on the NCI website it clearly says: “A phase II study also conducted by the developer [Burzynski] and his associates at his clinic reported on 12 patients with recurrent and diffuse intrinsic brain stem glioma. Of the ten patients who were evaluable, two achieved complete tumor response, three had partial tumor response, three had stable disease, and two had progressive disease. Patients ranged in age from 4 to 29 years.” The NCI felt its own source to be “definitive enough”, why not Liz? *Source: www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page5#Reference5.12 Merola clearly does not understand the difference between “responses” and cures. Similarly, he does not understand what constitutes “definitive evidence.” (Hint: It isn’t case reports, tiny case series published in bottom-feeding journals, or incomplete phase II trials. Moreover, just because the NCI cited a crappy review article by Burzynski that reported partial results phase II trials, a ten year old partial report of a phase II trial, a dubious paper published in an integrative medicine journal, and another review article published by Burzynski in a journal that appears not to be even indexed by PubMed does not constitute “definitive evidence” that ANPs work. All it means is that the NCI was examining the existing published evidence on its way to writing this: To date, no randomized controlled trials examining the use of antineoplastons in patients with cancer have been reported in the literature. Existing published data have taken the form of case reports or series, phase I clinical trials, and phase II clinical trials, conducted mainly by the developer of the therapy and his associates. While these publications have reported successful remissions with the use of antineoplastons, other investigators have been unable to duplicate these results [10] and suggest that interpreting effects of antineoplaston treatment in patients with recurrent gliomas may be confounded by pre-antineoplaston treatment and imaging artifacts.[11,14,16] Reports originating from Japan on the effect of antineoplaston treatment on brain and other types of tumors have been mixed, and in some Japanese studies the specific antineoplastons used are not named.[9] In many of the reported studies, several or all patients received concurrent or recent radiation therapy, chemotherapy, or both, confounding interpretability. Mr. Merola, that’s hardly “definitive”! Nor is the “definitive” study by Hidaeki Tsuda featured in the second Burzynski movie, given that nothing has been published to allow us to evaluate the methods. Nor is the fact that The Lancet Oncology apparently editorially rejected a manuscript submitted by Burzynski evidence of any sort of “conspiracy” against him. Indeed, I now probably know why Burzynski’s manuscript was rejected. Look at the title: “Glioblastoma multiforme: A report of long-term progression-free and overall survival of 8 to over 16 years after antineoplaston therapy and a review of the literature”. Yes, the title seems to indicate that this is just another small case series. No wonder The Lancet Oncology didn’t even bother to send it out for review! Of course, Merola can’t resist a swipe at yours truly, who was quoted in the article: A guy who is paid to write blogs attacking this innovation and other innovations that compete with the status quo, a guy who has never once met a Burzynski patient, never once visited the Burzynski clinic, a guy who supposedly finished his residency and now writes “thought police” blogs for a living — yeah, let’s hear more about what this guy has to say, that’s productive. He does fit the angle for Liz’s one-sided propaganda, so I understand why she included his irrelevant opinion. I don’t know whether to laugh or be annoyed at Merola’s continued lies about me. Once again, I do not need to visit the Burzynski Clinic to know that ANPs almost certainly don’t work. I did finish my residency and am board certified in surgery. If Mr. Merola doesn’t believe that, he can go to the American Board of Surgery website and search for my name in the section that lets the public verify the board certification of surgeons, realizing that you can’t become board certified without finishing an accredited residency. Finally, I don’t actually blog for a living. It’s my hobby. I’m not paid at all for my work at SBM, and at my not-so-super-secret other blog I make a small amount of money that I could completely do without if that gig ever went south or I decided to bolt. As for having something worthwhile to say, well, let’s just say that I’d put my record for science-based analysis against Mr. Merola’s record for pseudoscience-based propaganda any day, particularly in light of his latest paean to another brave maverick, this time promoting the long-discredited cancer quackery known as laetrile. At least Merola included a link to my page on SBM. He seems to think it’s something nefarious, while I’m more than happy to include a link to it here. Please, read. Why did the FDA cave? What is puzzling to me is why the FDA caved. While it is true that the ANP Coalition managed to get a few misguided legislators, the most prominent of whom was Senator Kelly Ayotte (R-NH), to write letters to the FDA urging that it consider allowing ANPs to be made available through single patient IND/expanded access to their constituents, the letters were fairly wishy-washy. Moreover, the Change.gov petition to the White House response to a We The People online petition to have the FDA allow Elisha Cohen access to ANPs through compassionate use exemption resulted in a response that, boiled down to it essence, said that it’s the FDA’s job to make such decisions, and let the FDA do its job, along with links to various FDA web pages with information about investigational drugs and information about how the FDA could be contacted. It was a shockingly reasonable response. One rationale reported in Szabo’s article seems to be that by allowing ANPs to be used but excluding Burzynski from having anything to do with administering them other than producing them, in essence, relegating him to the role of a drug manufacturer, useful data might be obtained and patients protected while obtaining that useful data. This is utter nonsense. As Howard Ozer is quoted in Szabo’s article: “This is a cop-out,” says Ozer, director of the University of Illinois Cancer Center, who studied Burzynski’s research results in the 1990s. “Because it can be toxic and cause life-threatening sodium problems, patients (who take antineoplastons) are at risk and could die,” Ozer says. The scientific community will learn nothing by giving these patients antineoplastons, because there will be no comparison group, Ozer says. Any doctor who agrees to give antineoplastons could be biased in favor of them, which could skew the results. Exactly. As Dr. Peter Adamson points out in the article, after 37 years, if antineoplastons were the wonder drugs that Burzynski claims them to be, scientists would know it by now. ANPs aren’t wonder drugs. There isn’t even any evidence that they’re better than standard-of-care, as dismal as that is for DIPG. It is possible that one of the Senators or other legislators did indeed pressure the FDA, leading the relevant enforcement officials to come up with this decision in order to get them off their backs without actually doing anything. They could credibly say, “Hey, we offered compassionate use, but I’m sure you’ll agree that, given his history, we can’t let Burzynski be the one to administer the ANPs on compassionate use. Look at his history of playing fast and loose with IRBs and not obeying the rules with respect to INDs.” This might even sound convincing and seem clever, which is why I rather suspect that Dr. Henry Friedman is right when he says: “It will deflect criticism from anybody who says the FDA is unilaterally denying dying patients something that could help them,” says Friedman, deputy director of the Preston Robert Tisch Brain Tumor Center at Duke University in North Carolina, who also reviewed Burzynski’s studies in the 1990s. “It will get FDA off the hook.” That, I believe, is exactly why the FDA did it, not to help dying children. Unfortunately, the consequences of the FDA’s decision are likely to be disastrous. Long-suffering families will have false hope extended to them once again, only to find out that it’s a useless offer. In addition to continuing to scramble to raise money, they’ll scramble to find oncologists willing to do the not-inconsiderable work to get a single-patient IND approved and administer ANPs, something few, if any of them, are likely to succeed at. The families don’t know it yet, but what the FDA has done will only add to their misery. Indeed, I’ve already seen reports that patients have contacted “dozens” of pediatric oncologists looking for one who will administer ANPs, and, given that the number of pediatric oncologists in the US is small, a significant proportion of them are likely to be contacted. Meanwhile, Burzynski gets a propaganda victory, thanks to the FDA’s failure to enforce its own standards, and alt-med proponents get another conspiracy theory to add to the list of conspiracy theories surrounding Burzynski already." http://www.sciencebasedmedicine.org/stanislaw-burzynskis-propaganda-victory-on-antineoplastons-the-fda-caves/
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sunspotter sunspotter 4 years ago
Missed the last sentence:


Burzynski likes to steal money raised by the families and friends of sick kids in order to fund his lavish lifestyle. He finds a few new victims - often in Europe - every year.

When your beloved child is dying from a sadly incurable disease, you will clutch at any straw. And charlatans like Burzynski are happy to provide that straw.

These are the situations that Stanislaw Burzynski- may he die in agony and rot in hell as soon as possible - exploits.
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sunspotter sunspotter 4 years ago
Burzynski likes to steal money raised by the families and friends of sick kids in order to fund his lavish lifestyle. He finds a few new victims - often in Europe - every year.

When your beloved child is dying from a sadly incurable disease, you will clutch at any straw. And charlatans like Burzynski are happy to provide that straw.

These are the situations that Stanislaw Burzynski- may he die in agony and rot in
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sunspotter sunspotter 4 years ago
Never. For obvious reasons.
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Zorch305 Zorch305 4 years ago
When are the Flea Dicks Association gonna approve of this
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ALERTS100%to10000%GAIN ALERTS100%to10000%GAIN 4 years ago
BZYR gonna run
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MD05 MD05 5 years ago
Lets hope they let him do his work this time. Amazing none of the documentaries did any good.
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BJ2018 BJ2018 5 years ago
The research funding agreement is renewed again so that's good. I didnt notice other changes. Maybe we will get more news this year regarding the holds and more trials and whatnot. Still long for me
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Nagasdog Nagasdog 5 years ago
Annual report 10K out? any thing good?
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BJ2018 BJ2018 5 years ago
when is their quarterly financial report due?
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BJ2018 BJ2018 5 years ago
I think some financials this week maybe. Hoping for good news!
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Nagasdog Nagasdog 5 years ago
ANY NEWEST ?
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Nagasdog Nagasdog 5 years ago
Friend of mine who went to visit relatives in Houston Texas carefully he found out that that the Buerzunski clinic really is open and really his relatives told him that cures people. I dont know why they dont come out with some kind of news when really they have positive results from people they cured. According the news my friend collected now he is going to buy as much as he can.
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Nagasdog Nagasdog 5 years ago
I recall my personal opinion, looks no news.....
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Nagasdog Nagasdog 5 years ago
My personal opinion, this month will come out news.
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BJ2018 BJ2018 5 years ago
Am I seeing a bullish reverse-head-shoulders pattern on top of a bullish breakout past the 50day moving average? : )
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BJ2018 BJ2018 5 years ago
Its a different private company in Isreal. The process seems the same though: Amino Acid Derivatives. BZYR owns the patents in the United States so we have an upper hand. Either BZYR get bought out or the process gets more well known and the FDA can no longer ignore the results and approves further trials with BZYR. Or bzyr could continue treating under the "Right to Try Act" that was just passed last year or the "orphan drug" program as well.
: ) Lots of possibilities it seems.
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Nagasdog Nagasdog 5 years ago
But nothing mention for Burzynski's clinic and or cure.
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BJ2018 BJ2018 5 years ago
Looking good. I got some more of the stock. This just came out:

https://www.jpost.com/HEALTH-SCIENCE/A-cure-for-cancer-Israeli-scientists-say-they-think-they-found-one-578939

Looks like others are also showing that the process works! BZYR is set up to take advantage of this as soon as fda allows it. and under the new law and new head of fda this could happen at any time : ) good spec play id say
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Nagasdog Nagasdog 5 years ago
Still breathing...............
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BJ2018 BJ2018 6 years ago
I read the report. looks normal to me. glad i bought cause bids are higher now. looks like the funding agreement is in place : ) What a deal. Good stock to own for a spec play imho
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Nagasdog Nagasdog 6 years ago
10 Q out, Does any body understand better than me, is this filing any good or better?
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BJ2018 BJ2018 6 years ago
Freedom-To-Try Bill should help BZYR. Stock looks to be bottoming. Good sized bid here
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Nagasdog Nagasdog 6 years ago
Another person 15 years old he cured in Burzynski clinic. I know his father
we use to work together. I asked if there are many people for cure ,he told me yes and 8 out of 10 cured as he knows. soon will approve from FDA after all the president Trump he signed it.
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Nagasdog Nagasdog 6 years ago
Another wondering. Why Dr. Burzynski never came out to report (lets say) this year cured these numbers of people? to mention something?
And as everybody see this price is the lowest in the last 5 years.
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Nagasdog Nagasdog 6 years ago
Very good, but I wonder why none of these cured people came out to talk in news papers about it?
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Nagasdog Nagasdog 6 years ago
Very good, but I wonder why none of these cured people came out to talk in news papers about it?
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Nagasdog Nagasdog 6 years ago
I found more and more people that they or heard others they say they know people they cured in Burzynski clinic. And now that the government approved to try any new treatment expect the best, I wish to have $$ to invest on. Very soon we will read tremendous news, I expect within 2 weeks the way I make search.
Good luck to all of us.
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Nagasdog Nagasdog 6 years ago
Any day FDA will approve the BZYR clinics therapy, more and more I hear positive.
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BJ2018 BJ2018 6 years ago
Technical sells most likeley I imagine. Burzynski still owns over 80% of the company and is funding the company as well so seems like a good deal to me
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Nagasdog Nagasdog 6 years ago
The lowest the last 5 years? Why?
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