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Stanislaw Burzynski in USA Today: Abuse of clinical trials and patients versus the ineffectiveness of the FDA and Texas Medical Board

I’ve made no secret of how much I despise Stanislaw Burzynski, the self-proclaimed cancer doctor and medical researcher who has been treating patients with an unproven, unapproved chemotherapeutic agent since 1977, seemingly slithering around, under, over, and past all attempts to investigate him and shut him down. Along the way, Burzynski has become a hero to the cancer quackery industry, touted as the man who can cure incurable cancers that science-based medicine can’t, even though his treatment, antineoplastons, allegedly peptides isolated from blood and urine that normally keep cancer in check in healthy people, are by any reasonable definition chemotherapy. Indeed, they are toxic, with a number of side effects reported, the most common and dangerous of which being life-threatening hypernatremia (elevated sodium levels in the blood). All you have to do is to type Burzynski’s name into the search box of this blog, and you’ll find copious documentation of the abuses of patients, science, and clinical trials perpetrated by Stanislaw Burzynski and the cult of personality that has evolved around him. He’s even acquired his very own film propagandist, a credulous fellow named Eric Merola, who has made two astoundingly bad documentaries that are nothing more than unabashed hagiographies of the brave maverick doctor curing cancer where no one else can. They’re chock full of misinformation, pseudoscience, spin, and obvious emotional manipulation, and the first one, at least, was very popular.

For the longest time, I’ve been hoping that major mainstream news organizations would take this story on. It’s happened from time to time, but until 2013 it hadn’t happened in a long time. Earlier this year, the BBC featured Burzynski in an episode of its long-running series Panorama. It was a mixed bag that took the fairly easy path of making it all about the patients and never really delved into what I believe to be the central mystery of the four decade long Stanislaw Burzynski story, and that’s how he’s managed to keep his medical license and register clinical trials right up until 2012. That was a disappointment, although much of the rest of the Panorama episode was very good. He still has his medical license, but as I’ve pointed out several times, the FDA placed a partial clinical hold on Burzynski’s antineoplaston phase II clinical trials back in the summer of 2012. A partial clinical hold means that no new patients could be enrolled in his clinical trials, but patients already on them could continue to receive antineoplastons. In 2012, apparently a child died on antineoplastons, and so a partial clinical hold was placed on the trials involving children. That clinical hold was extended to adults in January 2012, with much wailing and gnashing of teeth among Burzynski apologists, as the FDA investigated between January and March. We now know the results of that investigation, but we never knew much about how that partial clinical hold came about.

Now, thanks to Liz Szabo at USA Today, we know from her article Doctor accused of selling false hope to families:

On the last day of his life, Josia Cotto’s parents gave him a choice.

The 6-year-old boy had been fighting an inoperable brain tumor for 10 months. When his mother, Niasia Cotto, found him in his bed, unresponsive and unable to open his eyes, “we knew there was nothing else that we could do,” she said.

An ambulance took Josia to a hospice room at a local hospital. His parents covered him in a soft, blue-and-white blanket, hugged him and held his small hand for the last time.

“We told him the choice was his, whether to keep fighting or be in peace with God,” said his mother. “He chose.”

Josia’s parents would have paid any price to save him.

A Texas doctor, two months, earlier, had given them one: $25,000 upfront, by cash or check.

It turns out that Josia Cotto was the child who died of complications from Burzynski’s treatment:

The FDA’s patience with Burzynski apparently wore out after Josia died.

In a report sent to the FDA after the boy’s death, Burzynski’s staff acknowledged that his last blood sample, taken the day he passed away,showed a blood sodium level of 205 millimoles per liter, a level that is typically fatal. Burzynski’s staff blamed that reading on a “false laboratory report based on a contaminated sample.”

Yet hypernatremia is one of antineoplastons’ most common side effects, known to doctors for two decades.

One of Burzynski’s own informed consent documents — the form that patients sign before they begin treatment — put the risk at 21%.

On July 30, 2012 — six weeks after Josia’s death — the FDA forbade Burzynski from giving antineoplastons to any new children.

I was astounded to see that number. I’ve never, ever seen a sodium level that high. Typically, normal is typically between 135 and 145 mEq/L, with slight variations of that range depending on the lab. Burzynski’s excuse, which I’ve heard at various times as being due to an “improper blood draw” or as described above, is purest nonsense. A bad blood draw typically produces falsely elevated potassium levels, not sodium levels. Unless the technician spiked Josia’s sample with 3% saline or something like that, there’s no way to get the leve that high. Josia almost certainly died because of hypernatremia from antineoplaston therapy.

To me, this is the biggest revelation of the story: The story and identity of the child who was killed by Burzynski’s treatments. We also learn that—surprise! surprise!—Stanislaw Burzynski is an enormous tool. Look at him dismiss his critics, particularly former patients, many of whom, let’s recall, have terminal cancer, many of whom are dead:

Burzynski dismisses criticism of his work, referring to his detractors as “hooligans” and “hired assassins.”

As for criticism from former patients, Burzynski says, “We see patients from various walks of life. We see great people. We see crooks. We have prostitutes. We have thieves. We have mafia bosses. We have Secret Service agents. Many people are coming to us, OK? Not all of them are the greatest people in the world. And many of them would like to get money from us. They pretend they got sick and they would like to extort money from us.”

History will vindicate him, Burzynski says, just as it has vindicated other persecuted medical “pioneers,” such as Louis Pasteur. In the future, Burzynski says, everyone will use his therapies, and the cancer treatments used today — such as surgery, chemotherapy and radiation — will be regarded as barbaric. “There will be a time when people will see the light,” he says, “and our treatments will be used by everyone.”

You know, whenever I hear Burzynski fans like Eric Merola accuse skeptics of attacking cancer patients, of accusing them of horrible things, I think I will throw this quote right back in their faces. Here’s Burzynski calling his patients prostitutes, thieves, and mafia bosses, and “not the greatest people in the world,” while accusing them of wanting to “extort money from us.” Not surprisingly, he also liberally uses the Galileo gambit, but that’s not surprising, as he’s repeatedly made the hilariously arrogant and scientifically ignorant claim that he is a pioneer in genomic and personalized cancer therapy and that M.D. Anderson Cancer Center and other world-class cancer centers are “following his lead.” Indeed, he claimed to have invented the field 20 years ago. Sadly, his publication record does not support such grandiose claims.

There’s a lot more in this story, some of it contained in the sidebar stories Experts dismiss doctor’s cancer claims and Families run out of hope, money after cancer treatments. Other than some of the revelations that I didn’t really know much about before, much of what is contained in the rest of this story will be familiar to regular readers here. For instance, experts are saying the same things I’ve been saying for a couple of years now about Burzynski’s anecdotes of “miracle cures,” such as Hannah Bradley and Laura Hymas. The reasons for these anecdotes include:

  • Burzynski often relies on anecdotes, which don’t tell the full story.
  • Burzynski’s therapies are unproven.
  • Burzynski’s patients may have been misdiagnosed.
  • Burzynski’s patients may have been cured by previous therapy.

There’s a reason why I’ve spent so much time deconstructing Burzynski anecdotes, and it’s for all of those reasons plus that anecdotes are often interpreted incorrectly by patients without medical training. Even doctors who are not oncologists sometimes interpret such anecdotes incorrectly to indicate that the cancer therapy chosen is the therapy that cured the patient. It’s not just Burzynski patient anecdotes, but it’s any cancer cure anecdote. That’s why clinical trials are necessary to differentiate all these confounding effects from actual effects due to the treatment. Indeed, the patients featured in Ms. Szabo’s article have nearly all been discussed by me before, including Mary Jo Siegel, who had a fairly indolent cancer for which the standard of care has changed from very aggressive treatment up to and including a bone marrow transplant to less aggressive therapy that acknowledges that these are fairly indolent tumors. Worse, her story is lost in the mists of time, where what now exists are only highly selected medical records posted on various websites.

Indeed, Ms. Szabo even explains one aspect of the concept of pseudoprogression in a simpler way than I did, lo, those many moons ago:

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

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

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

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

FDA inspections, obtained through the Freedom of Information Act, show that Burzynski has repeatedly failed to follow that basic practice.

Pseudoprogression can be a real confounder in assessing the response of brain tumors to therapy, being observed up to 28% of the time. It’s most common after surgery and radiation therapy, although it can happen after chemotherapy too. Not coincidentally, Hannah Bradley had surgery, chemotherapy, and radiation, and Laura Hymas had radiation and chemotherapy. These are the sorts of pitfalls that real cancer doctors doing real clinical trials already know about and work to minimize. Burzynski, in his arrogance, never thought he needed to bother with the sort of expertise that could validate his therapy. None of this stops Burzynski patients from being lured into spending hundreds of thousands of dollars on Burzynski’s treatments.

It’s very heartening to see a story like this in a major news outlet, and I must congratulate Ms. Szabo for her thorough deconstruction of the phenomenon that is Stanislaw Burzynski. True, a bit of false balance did sneak in here and there. For instance, the Siegels are featured as are other Burzynski patients who believe he cured them when he almost certainly did not in a video accompanying the story, and the title of the series is a rather cliched “Science or Snake Oil.” However, the false balance that is so ingrained in the culture of journalism seems to be noticeably less apparent in this article than on many other stories about Burzynski that I’ve read. That’s good.

Before I close, I can’t help but mention that the most disappointing thing about this news story was that it still hasn’t revealed what I consider to be the two central mysteries of the Burzynski saga: First, how is it that Stanislaw Burzynski can still practice medicine? I know it’s Texas, but this has been going on for nearly 37 years. Second, why has he been allowed to continue to do clinical trials up until a little more than a year ago, and why is it that, even now, the FDA hasn’t shut him down permanently? Ms. Szabo sheds a little light on that, but nothing that regular readers of this blog don’t already know about the political machinations in the 1990s that led to Burzynski’s six dozen phase II clinical trials. Apparently, even Ms. Szabo and USA Today couldn’t crack that nut. Maybe public pressure can. The concluding section of the story tells us why we need to try:

No one told Josia’s parents about any of this.

Not Burzynski. Not the FDA.

Jose and Niasia Cotto had no idea that their son’s death prompted an investigation by the FDA, until they were contacted by USA TODAY.

The Cottos had long believed that Burzynski could have cured their son if only they had taken Josia to see him first, before giving him radiation and chemotherapy. They had even hoped to launch a non-profit, A Life for Josia Foundation, to help other children with cancer gain access to Burzynski’s treatment.

Now, they don’t know what to think.

Remember how I said that Bob Blaskiewicz will want your help? Now’s the time to contact him, if you haven’t already.

By Orac

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

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

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

To contact Orac: [email protected]

86 replies on “Stanislaw Burzynski in USA Today: Abuse of clinical trials and patients versus the ineffectiveness of the FDA and Texas Medical Board”

“Not all [quacks] are the greatest people in the world. And many of them would like to get money from [people desperate for a cure]. They pretend they [have a cure] and they would like to extort money from [patients/victims].”

That’s a mighty shiny mirror you’ve got there, Mr. Burzynski…

Sad to finally put a name to the story (the child who was killed by Dr. B’s “treatment.”)

Just had a look at the article in USA Today and of course the Burzynski fanboys & -girls are coming out of their holes in the comments section to defend their Maverick doctor, using all the usual tropes that we are so familiar with: “chemo causes cancer”, “big pharma is afraid to loose business”, etc.. All sprinkled with some patient anecdotes and some helping of unrelated “ObamaCare is evil” on the side.

Oh my god. What an enormous egotist. Patients *pretend* to get sick from his antineoplastons just so they can sue??? Like Josia *pretended* to die of them, and he couldn’t be bothered to even tell the parents the truth? Well, of course not; they were setting up a fundraising effort to help get other kids treated by Burzynski; of course he wouldn’t tell them the truth if they were raising money for him. Would upset the gravy train. But now they know. And if they are passionate enough to set up a fundraising campaign . . . well. I wonder if Burzynski’s just created another Rita Swan.

(For those who don’t know the story, Rita Swan’s son died of meningitis because her Christian Scientist practitioners told her that only prayer could save him and that he was getting better, all of which was completely untrue. As a result, she devoted her life to ending religious exemptions that shielded faith healers from prosecution, and she’s been remarkably successful although it has taken decades of very hard work.)

Hope this is cool, but I started a website just linking to all the various science/pro-vaccine articles I frequent. Hoping to have resources and articles as well. No ads on the site, not trying to make money. Calling it Sage of Autism.

http://www.sageofautism.com

Cheers.

Patients *pretend* to get sick from his antineoplastons just so they can sue???

Many of them are so perfidious that having paid Burzynski a small fortune, they *pretend* to progress in their illness and finally die, just so they can sue him for some money back.

In a report sent to the FDA after the boy’s death, Burzynski’s staff acknowledged that his last blood sample, taken the day he passed away,showed a blood sodium level of 205 millimoles per liter, a level that is typically fatal. Burzynski’s staff blamed that reading on a “false laboratory report based on a contaminated sample.”

That’s higher than the highest sodium I ever saw in almost 25 years working in clinical biochemistry labs that measure literally hundreds of blood sodiums every day. I have sometimes seen sodiums of over 180 in patients who did not survive.

I have only very rarely seen a falsely elevated sodium due to contamination; when someone has used sodium heparin as an anticoagulant for a blood gas sample, and then squirted the same sample into a tube for sodium measurement. Even then the sodium was only mildly increased.

I have often seen a high potassium due to the use of potassium EDTA as an anticoagulant (and of course due to hemolysis as Orac mentioned), but there simply isn’t enough sodium in a sodium heparin syringe to cause a false reading that high. I can’t think if any other way that sort of contamination could possibly happen, therefore I call BS.

A few of the pro-Burzynski folks on that article are claiming the FDA destroyed his records, even citing this as a reason no results have been published.

I have a feeling we’ll be seeing a lot more of this BS argument.

Incidentally, that reminded me of a time during the good old days when we had blood gas analyzers in the laboratory and doctors would run up with a sample on ice (these days many departments have their own blood gas machine).

One night I had just mixed and injected a sample into our blood gas machine when the doctor, who was waiting for the results, asked if I could run some electrolytes on the same sample. “What anticoagulant did you use?” I asked. If he had used lithium heparin it wouldn’t affect the results, whereas sodium heparin might falsely elevate the sodium, as I mentioned above.

“Anticoagulant?” he replied blankly.

I looked down at the machine, the only blood gas analyzer in the hospital, that was now entirely and solidly clogged with coagulated blood, and that it would take me the next couple of hours to dismantle and clean, and sighed.

Krebiozen – I too have felt the joy of cleaning the teeny weeny lines of the blood gas analyzer. I also have never seen a sodium that hight.

Herr Doktor: The dog ate it.

@Krebiozen #12: Must have been the really old days before color-coded Vacutainer tubes.

“AdamG
November 15, 2013
A few of the pro-Burzynski folks on that article
are claiming the FDA destroyed his records, ”

No problem, we can just reconstruct the data by ordering back-copies of all of the medical journals which have been publishing his results for the last 30 years.

hahahahahahahahahahahahahahahahahahah

Nick Theodorakis

@Krebiozen #12: Must have been the really old days before color-coded Vacutainer tubes.

It was some years ago. Isn’t arterial blood still taken with a plain syringe? I have had little to do with blood gases since BG analyzers were put in ITU, A+E and SCBU (that’s HDU, ER and NNU to Americans I believe). He should have flushed the syringe with heparin before doing the arterial stab, but didn’t.

@Bob added to the feed!

Repetitive self-promotion added to the killfile!

Going forward, you might want to confine the URL to the “location” box.

…. the take-away I get from this story is that he is still allowed to practice. I can’t say anything else; too upset by that, sorry

Ironic timing that this fake news release was published today on one of those “pay PR” sites.

(By the way, is this the “international oncology” conference Eric Merola says he attended recently? Anti-aging is the same as oncology in his world?!)

Burzynski Clinic Presents Over Five Years Survival Data From Phase II Trials of ANP for Inoperable Brain Tumors at the Congress

11/15/2013 | 09:34pm US/Eastern

The Burzynski Clinic (BC) announced today that it made a keynote speaker presentation at the 2nd Annual Congress of Asia-Pacific Academy of Anti-Aging Medicine in Beijing, China. Based on the presentation in Beijing, a total of 401 eligible patients (patients who received over 28 days of treatment) with advanced inoperable brain tumors have been treated with antineoplaston A10 and antineoplastons AS2-1 therapy (ANP) in phase II studies. Most of the patients (87%) were diagnosed with high-grade tumors and the remaining patients were diagnosed with low-grade tumors. The patients were diagnosed by pathologists not associated with BC and objective responses were verified by Central Radiology Review. The group of 77 patients (19%) survived over five years from the treatment start. Of particular interest were results in patients with brainstem gliomas. The group of 17 patients with brainstem glioma underwent the treatment and 65% of these patients survived over five years. An additional group of 42 patients diagnosed with diffuse intrinsic pontine glioma (DIPG) have been treated and a total of 19% survived over five years.

The quality of survival is very good and there is no long-term toxicity related to ANP.

These clinical results are very encouraging, since they describe a positive ANP effect on some of the worst malignancies in the entire oncology field, but they will require FDA approval.

Burzynski Clinic is committed to developing treatments for cancer based on genomic and epigenomic principles.

Forward-looking statements in this release are made pursuant to the safe harbor provisions of the federal securities laws. Information contained in forward-looking statements is based on current expectations and is subject to change, and future events may differ materially from those discussed herein due to a number of factors, including, but not limited to, risks and uncertainties related to the clinic’s ability to use Antineoplastons A10 and AS2-1. Burzynski Clinic does not undertake to update any such forward-looking statements or to publicly announce developments or events relating to the matters described herein.

For Burzynski Clinic
Carolyn Powers, 713-335-5664
[email protected]

© Business Wire 2013

Merola has written a rebuttal to USA Today:

http://ericmerola.com/my-email-to-usa-todays-liz-szabo-re-the-nov-15-2013-story-on-burzynski/

And our old friend Sheila Herron has chimed in on Merola’s Facebook page. She had a bad day:

Sheila Herron
I called USA Today and left a voicemail for Liz Szabo, the author of this biased hit piece, telling her shame on her for her biased journalism. I spoke withe the standards editor Brent Jones and complained to him about her bias in the article and on her Facebook page. The number is (800) 872-7073. The editor in chief is David Calloway. I also wrote an e-mail to Fran Visco of the National Breast Cancer Alliance/ Coallition, a lawyer and breast cancer survivor who attacks Dr. B. in the article, telling her shame on her as well. They are both on Facebook. I then wrote Glenn Beck and asked him to help us cancer patients- present and future, and Dr. B., by investgating and getting the word out about what is going on here, who the special interest groups are that are determined to destroy this dear, heroic, amazing man, my physician, who has, and continues to save my life. I’ve felt upset about this all day.

Ironic timing that this fake news release was published today on one of those “pay PR” sites.

Burzynski switched to ‘Business Wire’ as his peer-review journal of choice many years ago.

Merola has written a rebuttal to USA Today

It’s beyond cute that he caps it with a quote explicitly attributed to himself, Bringhurst dash and everything.

Best accidental tipoff I’ve noticed from the Scamway PR machine, courtesy Josephine Jones (PDF):

Once your treatment plan has been fulfilled, you will be discharged from the clinic and will return home to continue treatment with the assistance of your local physician(s).

This rather clearly does not mean “by us.”

If you appreciate the story, I’d recommend writing to the reporter and the editor to say so.

My guess is that the antivaxxers will *certainly* be writing, so…

@Krebiozen #22

Years ago when I was still drawing blood gasses the syringes were heparinized. Now most of the units’ instruments use little cartridges – no more fouled tubing.

I’ve never heard of a sodium over 200 in 15+ years in clinical labs, but we’d sometimes get pretty wacky values when a phlebotomist or nurse drew from above a running IV site. If antineoplastons are that sodium-rich, could something like that have happened as well…? Not that that excuses anything. Ugh. Ack. Every time Orac posts on Burzynski I read eagerly and feel worse.

Keokil,

Years ago when I was still drawing blood gasses the syringes were heparinized. Now most of the units’ instruments use little cartridges – no more fouled tubing.

I guess the doctor just grabbed a plain syringe without thinking, though this was circa 1990 in a hospital in a deprived part of London, and the equipment was somewhat primitive compared to what I was used to.

My experience with blood gas analyzers goes back to the early 80s when we would calibrate manually with injected buffer solutions and a cylinder full of a CO2/O2 mix, using knobs on the instrument, then get the patient sample in as quickly as possible before the damned thing would drift out of calibration again. Manually refilling and remembraning ISEs was fun too, as I recall. Now they are all plug and play.

I once suffered a needle-stick injury when a doctor just bent the needle over instead of capping the syringe with a blind hub – presumably they couldn’t find one. Oblivious to this I picked the syringe out of the ice and mixed it in the prescribed manner by rolling it between my hands. The needle sank an inch into the ball of my thumb. Thankfully, despite my fears, the patient turned out to be an old lady, not an IV drug user and was hepatitis negative. HIV was almost unknown back then.

I’ve never heard of a sodium over 200 in 15+ years in clinical labs, but we’d sometimes get pretty wacky values when a phlebotomist or nurse drew from above a running IV site.

The highest I ever saw was iatrogenic, and again related to blood gas measurement but at a different hospital. There was a blood gas machine on the intensive care unit, but it was out of action, with a large sign on it saying so, telling everyone to take blood gas samples to the lab. In the early hours I got a call from a doctor telling me his post liver transplant patient was acidotic and not responding to IV sodium bicarbonate. That was odd, since I hadn’t done any blood gases on that patient all night and I was standing next to the only functioning blood gas analyzer within 50 miles. You can imagine the awkward silence when I asked if he had noticed the large sign pointing out that the ITU machine wasn’t working. He either hadn’t or had ignored it, and had been happily monitoring his patient with a faulty machine.

Anyway, when I checked his patient’s gases on my functioning machine her pH was well over 8 and on checking her electrolytes her sodium was well over 180 – I don’t remember the exact value. She didn’t survive, but this was 30 years ago in the very early days of liver transplants when they generally didn’t anyway. As a naive young man I was horrified, not least by the shrugs I got when I reported it to my managers.

Well, it is true that most of Burznski’s patients won’t show the sort of secondary cancers that occur due to treatment with chemo, but that’s mainly because you can’t get a second type of cancer when you die from the first.

Wait a minute…I see goss negligence here. (REALLY?) The patient was sent home with no follow up after a treatment known to cause hypernatremia until the point he is taken to a hospital in a terminal level? Had this patient been followed with testing to moniter the sodium, the laboratory would of notified the provider when the levels hit a critical stage. This is obviously long before a terminal level as you all know. It is absolutely unbelievable that this could happen in this country. I agree with Orac, this quack needs his license revoked before he kills someone else. OT, sorta, but does Mercola have a license to practice medicine? I mean one other than the coupon on the back of the Mother Earth News. I have never found a record of his actually having a practice other than a Woo one.

Need I remind you of the Great Ormond Street video featuring little Luna and the awful effects of ANP?

I sent an email to Ms. Szabo congratulating her and I’m sending the article to my Congressman on the Health Energy and Commerce Oversight subcommittee, asking why the FDA has allowed this to go for so long.
Thanks Dr. Gorski and SBM, for educating me and the general public about Burznynski.

I haven’t opened this site in weeks, but as soon as I saw a link to the USA Today article about this guy, I bee-lined straight here. I was not disappointed. Lovely to see a major media outline shine light on this cockroach. Little comfort to his many victims, sadly…

Eric Merola has written a much longer response to the USA Today story on his Facebook page as an open letter to his subscribers.

http://burzynskimovie.com/index.php?option=com_content&view=article&id=148

Here are some highlights:

Wow, the medical establishment and the status quo cheerleaders have pulled out all the stops in their latest propaganda hit piece published in USA TODAY on November 15, 2013.

It’s enough to make one want to give up hope for any goodness in the human condition.

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

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

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

ANP was originally derived from human blood and urine. Since the early 1980’s is has been synthesized in a lab, and thus patented. USA TODAY takes another emotional stab describing the odor of ANP as “unpleasant”. In comparison, nurses have to wear full anti-toxic suits to administer most chemotherapy, and must stand behind huge metal walls when administering radiation. Why mention the “unpleasant odor?” It gives the reader the illusion that somehow this doctor is giving his patients urine, thus resulting in an “unpleasant” emotional response. (Never mind that the widely used drug Premarin is pregnant horse urine).

When you read the USA TODAY diatribe, you will find this type of rhetoric a constant throughout.

This is likely the industry’s last “Hurrah!” before trying to finally shut ANP down for good.

Taking one simple glance at history—using simple common sense—we will find that everything of scientific innovation has come from the fringe, and has directly threatened the status quo at the start. From The Wright Brothers to Steve Jobs – they were all once considered “fringe mavericks” until their efforts merged into the mainstream and became a participant in the “status quo.” The status quo is there to create its own legion of followers, while only those who dare to step out of it and take a risk with something that could change it—those are the only people in human history that have ever contributed to changing it. These innovators didn’t listen to anyone except their own hearts and minds—while ignoring all the noise around them.

Remember what frightens the establishment about Antineoplastons has nothing to do with a Polish man in Texas who invented them. It’s about their loss of control and authority—over a highly profitable and highly sustainable share of a totalitarian market. Anyone who feels the need to come up with “Conspiracy Theories” to explain the lack of acceptance of ANP by the establishment in any other way, simply doesn’t understand how the system works.

In solidarity,
Eric Merola

I’m shocked how many people support this guy. It seems like all an alt-med quack has to do is claim that the “machine” is holding them down and the conspiracy folk come out in support. Shame.

Conspiracies provide *just* enough doubt the the lay public for them to think, “what if?” We all have things we question about the establishment, but most of us hardly view that everything is a conspiracy. Hopefully it’s ridiculous enough that people won’t fall for it. I find it incredible that he says conspiracy theories about why ANP isn’t excepted are ridiculous…when it’s so obviously [the conspiracy] that the establishment doesn’t want to lose control. These groups are like cults. Straight up cults.

So, Merola claims that “not one patient has died of the ANP treatment, ever!” So how about the kid who is cited in the very article he lambasts?

Should be interesting….

I’m not a violent man by nature. I’d much rather live and let live. But this guy I wouldn’t spit on if he were on fire. If he happened to fall belly first onto a butcher knife I’d be sorely tempted to just walk the hell on by. He’s selling snake oil to people who are desperate for a real cure with a positive outcome, and he doesn’t even care that so many of his patients die. There used to be a derogatory term for a surgeon who was so bad that his patients had a better chance to live if they did not allow him to hack them up. I forget it now, but Bursinski sure as hell qualifies. The man’s a ghoul, and a graveyard filler.

DLC — the word is butcher.

Regarding the Merola response to USA Today, there are a couple of observations that can be made. None is all that new or exciting, because the diatribe is just a lot of generalizations. But still . . .

It is not true that all scientific innovation comes from the fringe. If you look at the basic discoveries and laws of chemistry, from Lavoisier to Gibbs, they come from establishment figures. Lavoisier was so establishment that he was executed by the French Revolution. The laws of particle motion and much of particle physics came from Cambridge, and the anatomical studies that led to modern medicine came from European universities. Even the Wright brothers were not fringe, per se. They just happened to be working in a field that was fairly competitive at the time, and their skill in engine building was one of the necessary requirements for doing what they did.

We might concede that aseptic surgery was a little slow in being adopted in the US, but the point is that real life evidence ultimately forced its adoption, just as the lumpectomy has apparently replaced more radical surgery for a considerable number of patients.

The other part of this misleading argument is that discoveries that changed the ruling paradigm did not remain hidden away. It obviously took a few years for some of the older crowd to adapt to modern wave mechanics and quantum theory, but the system as a whole adapted quite readily and even reasonably quickly.

Of course the big secret is that these laws and discoveries were subjected to testing and found to be useful. Lots of other hypotheses were discarded along the way, including phlogisten, the idea that heavier objects fall faster, the idea that matter can be destroyed in a chemical reaction.

The other argument made by Merola that I think should be flogged more heavily by the rationalist group (skeptics, if you will, but this is so obvious that it doesn’t require a lot of mental skepticism) is the argument that Dr B is an innovative scientist. It’s painfully obvious that Burzynski was essentially playing around with 1960s era science when he worked on the so called antineoplastons. It was an era in which the structure and organization of genes was unknown, and it was an era in which the tools for directly cloning, sequencing, and analyzing gene structure were not yet invented. I don’t fault Burzynski for looking for a magic bullet — just as botanists and early oncologists looked for botanical products, snake venom treatments, and the like. But only some magic bullets really have that magic, and the ANP treatment doesn’t seem to have a lot of it. In fact, if you look at Burzynski’s hypothesis, it essentially comes down to the idea that something that is a little lower in cancer patients is therefore, in some way, a causitive factor. Might be true (a very long shot) or might not. Meanwhile, science moved on, rapidly and powerfully, to the point that the ANP idea is just a minor subset of the idea of using histone modification as a last ditch effort to slow down growth of some cells.

In other words, if there had been any innovative impetus in Bursynski since the 1970s, he might have contributed some little thing to modern cancer biology and treatment. Instead, he stays stuck in his youth, flogging a largely discredited treatment. It’s only reality that has intruded upon his domain, forcing him to steal the idea of gene based therapy, which he obviously is not contributing to.

I don’t think that there is much likelihood of converting the truly bonded Burzynski supporters, but I think there was a significant failure in responding to all those sad families that were trying to raise money in foreign countries to bring their children to Texas. They should have been informed more forcibly that the ANP treatment is not innovative at all, that it has been a failure for 40 years and more, and they should look for different clinical trials if they want to go that route. Instead, they somehow became convinced that this was an experimental treatment that has obtained some good results. I don’t think that doctors want to destroy all hope in their patients and their families, but perhaps the English press could have done a better job.

@ Bob G: Thank you for a nice summary that will be helpful.

Another thing that the Burzynski crowd and Merola get wrong is the claim that Burzynski is the only one who has ever cured brain cancer. Merola aggressively preaches it; apparently he didn’t even do a simple internet search, which would have yielded several websites describing brain tumor survivors who had conventional treatment. Picking one randomly:

http://csn.cancer.org/node/137027

Science based medicine also provides real statistics for survival, something Burzynski won’t cough up the evidence for.

It is not true that all scientific innovation comes from the fringe. If you look at the basic discoveries and laws of chemistry, from Lavoisier to Gibbs, they come from establishment figures.

And let’s not forget the kooks’ all-time favorite Galileo Gallelei. He had issues with authority and was not exactly a diplomatic sort of a person, but he was working solidly within the academic establishment of the day, teaching in universities in Pisa and Padua, and he was a respected academic as well. He just had a talent for pissing off powerful people.

Facepalming at the conspiracy assertion that the FDA destroyed Burzynski’s records.

As skeptics, we’ve been demanding that Burzynski publish his results and pointed out that if his treatment works, his silence and opacity are arguably more damning than simply being a quack. Now they’ve given yet another excuse as to why he can’t publish. Ironically, if it were true that the FDA destroyed his records, it’s again more damning. If you sincerely think that there’s a conspiracy to cover up your cancer cure, the most rational action would be to spread your data everywhere you can, where everybody can see it. That is the opposite of what Burzynski has done.

@ Bob G. Just a layman here, but I do believe they were cloning stem cells at the university of Wisconsin in the 1960’s. The molecular structure of dna was discovered in 1953, while the first gene was sequenced in 1972. And I have read a little about genes, and it seems in some ways that we know less today. Like how the first organism to have its whole genome sequenced ( a worm a fraction of a mm long, about 1,200 cells total) has 24,000 genes, and the next organism ( a fruit fly, a much more complex organism) has only 18,000. Then the very next organism sequenced ( human) had only 25,000. But hey, I’m just using real numbers and facts, you can just go along with the consensus, call me a quack, laugh at me, and that makes you smart.
Why can’t people acknowledge that this cancer treatment deserves more research and funding. Rather than pretend we’re all smarter then this guy. Oh, and by the way, everyone here keeps talking about the misfortune of some kid dying from high sodium levels in the blood. But hospitals kill THOUSANDS of people every year in routine procedures, by accident, and gross negligence, and that’s ok. They don’t need their licenses suspended. Yet this guy is trying to do all new treatments. Ever think that this may have been a tragic accident. Which means their might be more safety protocol necessary, to make it completely avoidable. As opposed to other treatments, drugs, even vaccines!, that you accept a completely unavoidable risk, that you might be killed.

Why can’t people acknowledge that this cancer treatment deserves more research and funding. Rather than pretend we’re all smarter then this guy.

Troy, why don’t you acknowledge that I am the handsomest man in the universe and bench-press 5000 pounds? Oh, right, because you don’t have any evidence to support those claims. Why don’t we “acknowledge” that Burzynski’s treatment actually does one single g–d— thng that helps even one cancer patient survive any longer, or with any improved quality of life? Because there’s no evidence that it does.

Entitlement syndrome is disgusting, Troy, and it doesn’t make it one bit less disgusting that you’re displaying your disgusting entitlement syndrome on behalf of Burzynski rather than yourself. You’re still whining like a brat that you only get treated as the genius who has the cure for cancer when you actually have the cure for cancer, and you can’t get everyone slobbering all over you with gratitude just because you say you have it. Well, boo-fricking-hoo, Troy, and an extra “screw you” for slamming the doctors and hospitals giving people science-based treatment for cancer instead of Burzynski’s useless quackery.

Burzynski has had decades to do more research. He claims to be doing clinical trials. If there is anything to his theory, he should publish the results.

Either it works or it doesn’t. If it doesn’t work, he is conning dying people out of large amounts of money, and depriving them of the chance to spend their last months with their families. If it does work, he has condemned many innocent people to death by not publishing his results so other doctors can use his treatment. Doctors who are really trying to cure cancer don’t destroy the records that could help them figure out what works, what doesn’t, what might need changing, and whether they’re on the wrong track.

Yet this guy is trying to do all new treatments.

“New”? Here are your choices, Troy: Are “antineoplastons” cytotoxic, HDAC inhibitors, or some combination of these?

I will note in advance that they’re pretty freaking pathetic by either standard.

Troy,

Just, what are your assumptions?

Can you tell us point by point each of your assumption regarding the scientific process used by students and investigators and also, your assumption regarding Burzinski?

Thanks
Alain

Troy, ny,December 21, 2013:

@ Bob G. Just a layman here, but I do believe they were cloning stem cells at the university of Wisconsin in the 1960′s. The molecular structure of dna was discovered in 1953, while the first gene was sequenced in 1972. And I have read a little about genes, and it seems in some ways that we know less today.

And how might that be? What ways?

Like how the first organism to have its whole genome sequenced ( a worm a fraction of a mm long, about 1,200 cells total) has 24,000 genes, and the next organism ( a fruit fly, a much more complex organism) has only 18,000. Then the very next organism sequenced ( human) had only 25,000. But hey, I’m just using real numbers and facts, you can just go along with the consensus,

Perhaps you should “have read a little [more] about genes,” or asked someone who actually understands genetics, since you seem to be under the mistaken impression that the size of an organism’s genome has some profound connection with your impression of the organism’s phenotype.

call me a quack,

I wouldn’t call you a quack, since you haven’t shown us indications that you are one. A Dunning-Kruger example, almost certainly, but not a quack (until you try to sell us magic potions, like Burzynski’s).

laugh at me,

Not would I laugh. Dunnif-Kruger syndrome is a cause for pity, not laughter.

and that makes you smart.

Your lack of understanding doesn’t make anyone ‘smart’.

Why can’t people acknowledge that this research and funding.

Why do you think that Orac spends so much time writing grant proposals for research in various cancers? Wouldn’t that behavior seem to show some acknowledgment that “cancer treatment deserves more research and funding”?

Rather than pretend we’re all smarter then this guy.

(I presume that ‘this guy’ refers to Burzynski.) No, we don’t claim to be smarter that Burzinski, just infinitely more honest and empathetic, less willing to defraud random cancer victims and the FDA. We do stand (or sit, as the case may be) in amazement at Burzynski’s ability to get away with skirting the laws and regulations for so long, at his prowess at scamming so much money from so many marks.

Oh, and by the way, everyone here keeps talking about the misfortune of some kid dying from high sodium levels in the blood.

We mention this in light of Burzynski’s absurd claims that his chemotherapy has no danger, no side-effects, and couldn’t possibly kill His marks patients.

But hospitals kill THOUSANDS of people every year in routine procedures, by accident, and gross negligence, and that’s ok. They don’t need their licenses suspended.

What does that distraction have to do with Burzynski’s fraud? Who has ever said that gross negligence is ok? Do you have any credible sources for your mushy figures?

Yet this guy is trying to do all new treatments.

Burzynski’s chemotherapy was new over thirty years ago, when it was found to be possibly efficacious, marginally, in the treatment of a single cancer variety. Other treatments are known (and have been known since Burzynski’s first claims) to be more efficacious and safer at treating the only cancer variety his chemo has any effect on.

Ever think that this may have been a tragic accident.

It may have been an accident. The tragedy is that the patient (with his family and the well-wishers that Burzynski defrauded) was Burzynski’s mark.

Which means their might be more safety protocol necessary, to make it completely avoidable.

Of course, Burzynski has avoided safety protocols like the plague, usually by placing his pets (co-conspirators?) on the IRB that is legally responsible for overseeing all aspects of Burzynski’s ‘research’, especially the safety protocols.

As opposed to other treatments, drugs, even vaccines!, that you accept a completely unavoidable risk, that you might be killed.

We accept risks serious problems (even death) when the risk is low and the likelihood of gain is acceptably high. The processes that lead toward approval (or not) of drugs (even vaccines!) are designed to measure risks and benefits. The processes that occur with approved drugs (even vaccines!) refine and perhaps correct those measurements. Should any of these processes reveal that the risk-benefit ratio is not good enough, approval is not granted or is rescinded.
Burzynski’s big idea was to sign up or those processes and subvert them, so that he did not ever produce measurements of risks or benefits. In fact, the FDA has found that significant portions of the partial measurements/progress reports were faked.

In my eighth paragraph above
the word marks should have <strike> markup; the word His is capitalized to indicate how Burzynski’s ego would likely render it.

And in the my last paragraph above, the word ‘of’ is missing from the phrase ‘risks of serious problems’ in the first sentence.

@Troy – wow, that’s really deep (sarcasm.) You do realize your profound realization that genome size doesn’t necessarily match phenotypic complexity is taught in freshman biology, right? (One of the factors involved is that organisms with multiple life stages often require a different set of genes for each life stage.) Also, try to read for comprehension next time. If the first gene wasn’t sequenced until 1972, then Bob G. is correct in saying that the “structure and organization” of genes was unknown in the 1960s. Lastly, its ridiculous to assert that we know less about genes now than we did in the ’60s. It’s because we know more that we also realize how much more there is to discover – that’s what makes science so exciting. But Burzynski isn’t interested in discovery – he’s interested in making money off of desperate people. He’s been charging people thousands of dollars for his “therapy” for 30+ years without presenting a shred of evidence that it actually works. The old “science doesn’t know everything” chestnut isn’t going to justify that kind of behavior.

The government agencies that now sit in judgment of Dr.
Burzynski are severely corrupted by special interests and cannot be trusted. The FDA is looking out for the financial interests of big pharma and other big money cancer therapy interests. The government long ago limited clinical trials to those who previously had unsuccessful conventional treatments. It’s not surprising that some patients soon died.
When you read between the lines, you find evidence that some of Dr. Burzinski’s patients greatly benefited from his treatments and others did not or may have even been harmed.
Since there are many different types of cancer this really isn’t surprising. Powerful special interests stand to lose huge amounts of money if conventional treatments are replaced with something completely different. This is what the fight with the government is really all about.

@Kelly – except that if he treatment worked, any major Pharma company would have ponied up hundreds of millions of dollars to buy it, to get a leg up on their competition……logic certainly isn’t a strong suit of the typical Dr. B fanatic.

The government agencies that now sit in judgment of Dr.
Burzynski are severely corrupted by special interests and cannot be trusted.

And your evidence for that accusation?

Do you HAVE any evidence, or is your logic along the lines of “IF government agencies were ordered to surpress Miwakuh Kyuurs by big pharma paymasters, they’d say there was no evidence for B.’s treatment being any good; they say there’s no evidence for B.’s treatment, THEREFORE they’re corrupted by special interests”? That’s a fallacy called “affirming the consequent”; I can use the same logic to ‘prove’ that my uncle Charley is a bulldog, since if he was a bulldog he’d love steaks.

The FDA is looking out for the financial interests of big pharma and other big money cancer therapy interests.

FACT: Stan Burzynski has made himself a very, very rich man by exploiting what even his own legal counsel acknowledges is a loophole in the law, allowing him to market his UNPROVEN treatments as if people should be paying HIM for letting him experiment on them.

How come you’re not willing to consider the idea that maybe it’s the single doctor rolling in the money and adulation who’s telling lies for profit, hmmmm?

The government long ago limited clinical trials to those who previously had unsuccessful conventional treatments. It’s not surprising that some patients soon died.

Yeah, and if you understood what you’re attempting to judge, you’d realize it SHOULD be that way. You might try to tow a drowning person in to the shore with a line of dental floss. You wouldn’t do it if you have a perfectly good rope there. You’d only try the desperate experiment (the dental floss, or Dr. B’s treatments that STILL don’t have any completed clinical trials indicating efficacy after thirty years) when more reliable methods (conventional treatments) have been tried and failed.

When you read between the lines, you find evidence that some of Dr. Burzinski’s patients greatly benefited from his treatments and others did not or may have even been harmed.

The problem with “reading between the lines” is that any damn fool can see what they want to see that way. If I want to, I can claim that I see your admission that you’re actually a paid publicity representative for Burzynski, hiding “between the lines” of your comments here. Does that seem legit to you? If not, then stop invoking the same principle to claim that B.’s trials should somehow be regarded as successful when they haven’t produced successful results.

Since there are many different types of cancer this really isn’t surprising. Powerful special interests stand to lose huge amounts of money if conventional treatments are replaced with something completely different. This is what the fight with the government is really all about.

Again, any EVIDENCE for this assertion, or are you hoping that if you ASSERT it over and over, that will replace any need for evidence?

Powerful special interests stand to lose huge amounts of money

They would also stand to make a lot of money if they started to take over the ANP market, if it actually worked as well as Burzynski claims (or actually worked at all).

if conventional treatments are replaced with something completely different

Even to qualify Burzynski’s treatments as “completly different” is not true:
– he has been using conventional chemo drugs, albeit in unusual – and unvalidated – dosage and applications;
– the ANP molecular structure, AFAIK, don’t represent a huge breakthrough in anticancer drugs, a very diverse family which already ranges from metal-based drugs (like cisplatin) to complicated organic molecules like Paclitaxel (taxol).
Well, ANPs would be a big breakthrough if Burzynski could find some time to publish his results.
(you know, like Semmelweis and his students did to prove that physicians needed to wash their hands in order to prevent puerperal fever).

When you read between the lines, you find evidence that some of Dr. Burzinski’s patients greatly benefited from his treatments and others did not or may have even been harmed.

I’ve been completely unable to find any evidence–between the lines, above the lines, below the lines, beside the lines wherever–benefited at all from his treatments. Can you provide examples ofm this evidence you claim exists? (And recall I’m asking for evidence, rather than testimonials from people claiming they’ve benefitted.)

Powerful special interests stand to lose huge amounts of money if conventional treatments are replaced with something completely different.

How so? If developing and marketing a new or improved treatment must always result in lost profit, no drug company would ever bother researching a new drug to treat an indication for which treatments exist.

Yet they annually spend tens or hundreds of millions researching new and improved drugs to treat things like cardiac disease, asthma, allergies–i.e., things for which they’re already selling existing therapeutics.

I read the 28 page report from the National Cancer Institute. It reaches no conclusions as to whether antineoplastons work or not. Instead it says that controlled randomized trials are needed but don’t exist. It cites a number of medical trials that do exist. It’s understandable that they would not accept information provided only by the clinic owned and managed by Burzinski as conclusive.
A previous study conducted by the Mayo clinic only had 9 participants. That study failed to show any benefit from antineoplastons but it was much too small to draw any conclusions. Dr. Burzinski never claimed that all cancer patients would benefit. The only thing that NCI established as proven is that antineoplastons are not free of risk of harm to cancer patients.

Pubmed lists these ID’s for Phase II trials.
15563234
12718563
as well as this non-Burzinski study which apparently Kelly referred to:
10069350
Unlike Burzinski’s reports, it notes
” we could not confirm any tumor regression in patients in this study”
A small number of patients, but doesn’t sound very promising.

I read the 28 page report from the National Cancer Institute. It reaches no conclusions as to whether antineoplastons work or not. Instead it says that controlled randomized trials are needed but don’t exist.

You mean from the 1991 visit? The one from which this quote gets bandied about?

“The site visit team documented anti-cancer activity in this best-case series and determined that Phase II trials are warranted to determine the response rate.”

P.S. Could you provide some information about finding the “28 page report”? Because it would totally suck if this were actually the report on Joseph Gold’s hydrazine cure that often gets mentioned in the next breath.

A previous study conducted by the Mayo clinic only had 9 participants. That study failed to show any benefit from antineoplastons but it was much too small to draw any conclusions.

I believe this has already been explained to you at SBM.

Dr. Burzinski never claimed that all cancer patients would benefit.

The problem isn’t what he’s claimed but what he’s failed to demonstrate–that even one cancer patient has benefited from antineoplaston treatment.

On teh other hand, we know that at least one has died while undergoing treatment due to antineoplaston induced hyponatremia.

Narad, the 28 page report I’m talking about is listed under Antineoplastons(PDQ)-National Cancer Institute.

Where? Do you mean that you printed out the Web page, it happened to come out at 28 pages, and you declared it a “report”?

I started reading that “report” — I don’t have time right now for the whole thing — but I noted that some researchers were testing analogs of the antineoplastons. If we accept, for the sake of argument,that Burzynski really developed a cure for cancer, or even some cancers, and that he has been willfully denying it to dying patients worldwide for his personal enrichment, one would think that those who developed analogs to get around his patents would do the decent thing, prove their findings, and humbly accept the unimaginable fame and fortune that would accrue to the discoverers of a cure for cancer. But somehow their work fifteen years ago doesn’t seem to have led to that result. I wonder why not.

@LW – I also believe that Burzynski’s original patents are just about to expire or may have expired already….making it a moot point.

Kelly Clover,

As you point out, the NCI web site says there is insufficient evidence available to show that antineoplastons are safe and effective at treating cancer. Logically there are two alternative explanations:

1. The evidence exists but has not been published.
2. The evidence does not exist.

If the evidence does not exist, then one may reasonably question what the Burzynski clinic has been doing all these years in their various registered trials. One might also wonder whether the evidence that is available shows a reasonable likelihood of good results in the trials that would be necessary to gather and publish proper evidence of effectiveness and safety.

If the evidence does exist but has not been published, then one might reasonably ask why that is. Various scenarios spring to mind; however, given the time involved and the work that has been claimed I can’t think of a particularly good reason for this.

Dr. Burzyinski and his clinic have been treating people with drugs of unproven effectiveness, and promoting the same actively. If a major pharmaceutical company had worked the same way Dr. Burzynski has worked they would be subject to quite justified criticism and condemnation.

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