Stanislaw Burzynski: Slapped down by the FDA once again

I sometimes think that Stanislaw Burzynski is a lot like the Bloody Mary of folklore, or perhaps Candyman of the famous horror movie—or perhaps like a number of other legends and horror stories—in that all it seems to take for him to show up in the blogosphere again is for me to recite his hame enough times. Yes, I know that it's a bit of confirmation bias on my part and whether or not some new Burzynski news happens to come to the fore again has little or nothing to do with my invocation of his name, but it is a rather amusing thought. Be that as it may, it was just late last week that I pointed out that another one of Burzynski's patients had died tragically. This week, I find out from several of my readers that a new warning letter from the Food and Drug Administration to the Burzynski Clinic dated October 18 had been posted to the FDA website. Basically, the FDA is calling out Dr. Burzynski for his promotion of antineoplaston therapy because his antineoplastons are considered investigational and it is illegal to advertise and promote investigational agents as being effective.

As the FDA warning letter states:

Antineoplastons are investigational new drugs that do not have marketing authorization in the United States. An investigational new drug (IND) application was submitted to the FDA in [REDACTED].

Promotion of an investigational new drug is prohibited under FDA regulations at 21 CFR 312.7(a), which states, “A sponsor or investigator, or any person acting on behalf of a 1 sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.”

The websites, including the posted press releases and embedded videos, contain claims such as the following that promote Antineoplastons as safe and/or effective for the purposes for which they are being investigated or otherwise promote the drugs.

The FDA letter then lists a number of examples from the Burzynski Clinic website, including glowing statements about how well antineoplastons allegedly work, press releases that are in essence nothing more that testimonials of miracle cures and amazing responses in patients, plus a number of promotional appearances by Dr. Burzynski himself in which he touts antineoplastons as being, in essence, the greatest breakthrough in cancer therapy ever. I'm amused to note that one of the clips mentioned by the FDA in its complaint was an interview that Burzynski did for KHOU in Houston appear no longer to be on YouTube, at least as far as I've been able to find. Two of the videos, which I have watched before, are now private, and I can't find the other part. However, the same video appears to be present on the KHOU website in two parts. The FDA points out that it is illegal to make these sorts of claims for a drug that has not yet been FDA-approved for a given indication:

As stated above, some of the above-referenced claims suggest that the drugs are “well tolerated,” “work without causing side effects,” and have demonstrated “remarkable” results. The totality of these claims suggest that Antineoplastons, investigational new drugs, are safe and/or effective for the treatment of the various types of brain tumors indicated above, when they have not been approved for these uses.

Since Antineoplastons are investigational new drugs, the products’ indication(s), warnings, precautions, adverse reactions, and dosage and administration have not been established and are unknown at this time. Promoting Antineoplastons as safe and effective for the purposes for which they are under investigation, by making representations such as those noted above, is in violation of 21 CFR 312.7(a).

I've discussed Burzynski on numerous occasions, and I think the FDA is actually being too easy on him. As I've pointed out as recently as last week, a credulously clueless filmmaker named Eric Merola made a "documentary" that was, in effect, a 90 minute commercial for the Burzynski Clinic and Stanislaw Burzynski that only contributed to his cult of personality, all with the obvious complete cooperation of Stanislaw Burzynski and his clinic. In addition, Burzynski advertises antineoplastons as part of his "personalized gene targeted cancer therapy," which I tend to refer to as "making it up as you go along." It's rather odd, of course (well, no, it isn't, actually), that somehow every single one of the "personalized gene targeted cancer therapy" regimens that Burzynski ever comes up with always seem s to include antineoplastons (or, sodium phenylbutyrate, which is the same thing as one of the antineoplastons that Burzynski sells). Regardless of what Burzynski calls them, however, he promotes antineoplastons with glowing terms.

Being a translational-clinical investigator myself struggling to try to identify molecular targets in breast cancer and develop strategies to exploit them to treat breast cancer, what makes my blood boil, what makes puts my anger on a low seething boil that periodically bubbles over, is just how blatantly Burzynski flouts medical ethics, just how bad his science is, and how he exploits his patients by promising them what are in essence "miracle cures" and then charging them tens to hundreds of thousands of dollars in order to take part in his "clinical trials." Sure, he makes lots of excuses for why he does this. He'll tell anyone who'll listen that he runs a small research institute, that he doesn't have the money, but, a far as I can tell, it's all a sham. Burzynski represents himself as someone who came to America from Poland back in the 1960s “with twenty dollars in his pocket, a theory in his head, and an indefatigable attitude that shown in his smile.” These days, he's incredibly rich.

If Burzynski really believed in his therapy the way he says he does, he could manage to do clinical trials the way they're supposed to be done, with no expenses related to the experimental treatment paid for by the patient enrolling in the trial. Sure, he might not be able to do more than a few clinical trials, but he could do carefully targeted trials that might actually tell us whether antineoplastons have anticancer activity, rather than his laundry list of phase II trials, only a few of which accrue very many patients and even fewer of which he ever publishes on. That's the way big pharma has to do it; it's the way that medical academia has to do it; somehow, Burzynski doesn't think he should have to do it that way. Instead, he thinks it's perfectly fine to force his patients to pony up their life savings and more, to the point where many of them feel as though they have to start holding fundraisers in order to pay Burzynski's exorbitant charges for what they view as their last chance to live.

Indeed, it's even been alleged that Burzynski will go so far as to persuade patients to refuse chemotherapy, stem cell rescue, and other conventional therapy in favor of antineoplastons. The Twenty-First Floor has noticed that a video was posted to YouTube by a disgruntled Burzynski patient accusing him of just that. Unfortunately, that video is now private (just like the KHOU videos that Burzynski used to have on his website). Whether these allegations are true or not, I don't know, although they go so far as to accuse him of falsifying medical records, but they are of a piece with FDA's previous criticism of how Burzynski has played fast and loose with ethical approval of his clinical trials by institutional review boards.

I like to think that the noose is slowly tightening around Burzynski, between the FDA warning letters and his ongoing problems with the Texas Medical Board, but I can't. Although it is hard for me to imagine someone more deserving of being shut down and completely shunned from any and all medicine, over the last 30 years Burzynski has had amazing staying power and an ability to dodge the law and to represent himself as a Brave Maverick Doctor whose antineoplastons are a far better treatment than chemotherapy and radiation to gullible alternative medicine mavens, despite a record that, when looked at objectively, is quite dismal. I keep hoping I'm wrong, but I can't help but fear that once again he'll manage to slither his way out of his current difficulties. I truly hope I'm wrong.

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I look forward to the day when Burzynski is no longer allowed to practice medicine. The same goes for M. Geier - I'm hoping that soon Hawaii yanks his license so hard out from under him that he falls arse over end back to the mainland.

Good to hear that at least some action is being taken. I really wish, though, that the FDA would be given more teeth by Congress. There's sadly only so much that they can do to smack down unethical creeps like Burzynski.

I am aware of someone who went to see Dr. Bruzynski and figured out during the office visit that they were being scammed. They were summarily ejected from the office when they raised objections in view of other patients. I think that says it all.

By Michael Finfer, MD (not verified) on 07 Nov 2012 #permalink

I'll bet Burzynski's wrist is just a little bit sore today.

By Dangerous Bacon (not verified) on 07 Nov 2012 #permalink

Although it is hard for me to imagine someone more deserving of being shut down and completely shunned from any and all medicine

Oh I don't know, I think Wakefield deserves that crown. Then again, maybe all these medical frauds and cranks are equal...

And seriously, the FDA has been on his back since the 70s? WTF?

From the FDA document:

phase III trials scheduled to begin in 2009.”

Wow, and yet, still no patients enrolled...

Also this:

Our survival for children in the age up to three years, is 50% at five years, which is remarkable.

I don't think it's come up before, and my lack of scientific knowledge is showing here, but can you just accept anyone of any age in a study? I would have thought that you would specifically pick an age range and then stick with it. -- Not that I expect him to do that. But I would have thought that accepting anyone of any age would be a huge red flag?

Now we just wait for the frothing, sub-literate screeds of his flying monkeys. It'll be the usual "U r payed by Big Pharma and FDA they want his antenaplastins for theirself as they know its safe nontoxic CURE FOR CANCEr have you seen the movie??? it is prof that anitonipaltins work!!!"

I am practically pleading for first comment moderation to fail today! :-)

I was reading about a case just yesterday where a young couple went to him, and had to quit after one month because "Dr" Burzynski was charging them $30k a month which was, obviously, way out of reach. The clinic had lied to them, saying "Pay up front and your insurance will reimburse you".

They applied for a few trials, but were shocked to discover that they had been rejected. Why? Stan hadn't told them that one of the drugs (that cost them $3200 at his pharmacy, rather than the $270 list price) was a standard chemotherapeutic agent. The very thing they'd been trying to avoid.

He's a conniving, dangerous old ba$tard.

I will never forget little Luna Petagine, face distorted from the swelling in her brain ("It means the tumour is breaking down!" quoth the clinic), staggering about in nothing but a nappy, desperately chugging from a water bottle, and dribbling a constant stream of urine behind her.

To do that to a three year old is pure, undiluted evil. She deserved so much better than false hope and a mad dash across the globe, paid for by kind relatives, friends and strangers.

While Dr B certainly deserves a big, expensive smackdown, I agree with flip that Wakefield was more deserving of sanction. Wakefield's work fraud caused far more harm which continues today, more than a decade after he started his condemnation of MMR in favor of his own vaccine.

The common thread between these 2 monsters is money. Wakers took a pile of cash from a lawyer who was drooling to sue against MMR (and continues to rake in cash for lying to autism crowds), while Dr B takes it from dying cancer patients to whom he returns nothing.

Dr B robs dignity from the the end of life while Wakers robs health and life from the beginning. That also makes Wakefield a more serious threat.

@elburto

Hear, hear. I just know that on of burzynski's little troll followers is bound to come up on this thread and spew some idiocy.

Just getting the popcorn ready for some entertainment.

Maybe another of Dr. B's phony lawyers will be sending threatening letters to science bloggers.

"Govern yourself accordingly"

It amazes me that the health fooldom crowd lionise Burzynski, since he is doing exactly what Evil Big Pharma do only much worse.

By Guy Chapman (not verified) on 07 Nov 2012 #permalink

Although I usually don't rank order alt med prevaricators/ con artists/ charlatans ( those descriptions should cover them all), I agree with flip and MikeMa that AJW indeed deserves a special place on anyone's list.

But here's a difference that should separate Dr B out for another consideration: B actually 'treats' people- he directly benefits through his fees AND through his pharmacy. AJW is more of an enabler who assists parents in neglecting children's health by foregoing vaccines ( although he did order non-essential invasive testing on 12 subjects). Dr B's actions are more direct and thus traceable.

However, we should also remember that those who spread mythology via alt med ( take a bow, Mike and Gary) are in a class by themselves. Dr B is often one of their prime examples.

By Denice Walter (not verified) on 07 Nov 2012 #permalink

I followed the link to Quackometer's interesting and controversial article on Burzynski's palatial estate in Texas. There was a lot of hand-wringing over it being ad hominem and stooping to the level of Burzynski's thugs when they threatened Rhys Morgan by showing satellite pics of his house. I agree with Le Canard Noir in this case though. The facts and science used to question Burzynski's antineoplaston treatment are solid and stand on their own. But his side uses ad hominems freely to paint anyone opposed to St. Burzynski as some kind of rapacious monster in thrall to Big Gummint or Big Pharma. These pictures are worth a million words. Six million, actually. The gaudy SRB initials in gold on the gate was a tacky, nouveau riche move and describes a man with a huge ego (and questionable taste). This is someone who lives in splendor on proceeds culled from the misfortune of others. As a marketing and branding professional, I believe this approach is an essential part of the argument against this quack. He has a professional film maker manipulating the emotions of millions through his heart-tugging "documentary." We can at least pull the curtain back a bit to show him sitting in his smoking jacket, looking at himself in lovingly with a gilt hand mirror, delivering his Nobel acceptance speech for the thousanth time.

By Pareidolius (not verified) on 07 Nov 2012 #permalink

@flip

I don’t think it’s come up before, and my lack of scientific knowledge is showing here, but can you just accept anyone of any age in a study?

I can't speak to the POV of scientific validity (though I imagine that including children in a study that also looks at adults could skew things a bit), but from an ethics standpoint, studies including children need very careful consideration by the IRB overseeing the study to ensure proper protections of this vulnerable population. Considering his IRB has also received a warning letter (which is, as yet, not closed out, meaning his IRB didn't do squat to correct the issues raised by FDA), I doubt that proper protections were even put in place.

@Pareidolius:

We can at least pull the curtain back a bit to show him sitting in his smoking jacket, looking at himself in lovingly with a gilt hand mirror, delivering his Nobel acceptance speech for the thousanth time.

Except he knows that antineoplastons are a scam and that he'll never be awarded any form of scientific or humanitarian recognition.

By Rich Woods (not verified) on 07 Nov 2012 #permalink

@ flip: There is a cancer treatment central registry at the NCI:

http://www.cancer.gov/cancertopics/factsheet/NCI/clinical-trials-cooper…

NCI's Clinical Trials Cooperative Group Program

Key Points

The Clinical Trials Cooperative Group Program is designed to promote and support clinical trials (research studies) of new cancer treatments, explore methods of cancer prevention and early detection, and study quality-of-life and rehabilitation issues.

Cooperative groups include researchers, cancer centers, and community physicians throughout the United States, Canada, and Europe.

"....The Cooperative Group Program involves more than 3,100 institutions that contribute patients to group-conducted clinical trials. More than 14,000 individual investigators are registered to participate in NCI-supported cooperative group studies. Cooperative groups place more than 25,000 new patients into cancer treatment clinical trials each year.

The groups differ in structure and research focus. Some groups, such as the Children's Oncology Group, consist of investigators that have a particular medical specialty (e.g., pediatrics); some, such as the Radiation Therapy Oncology Group, study a specific type of cancer therapy; and others, such as the Gynecologic Oncology Group, focus on a group of related cancers. The groups share a common purpose—to develop and conduct large-scale trials in multi-institutional settings."

What I want to know is...how can one substance (antineoplastin) be a *treatment/cure* for every type of cancer?

While Dr B certainly deserves a big, expensive smackdown

The part of me that spends several hours per week in the 19th century favors horse-whipping.

Hey, even a week in the stocks and stripping his ill-gotten gains away would be a good start...

By Jay Chaplin (not verified) on 07 Nov 2012 #permalink

I have to say, I think Burzynski is much worse than Wakefield. They're both profiting off of lies and the suffering of others, but Wakefield, as some noted above, is more of an enabler. He dissuades people from vaccines, he encourages useless therapies for autism, and he accepts lots of speaking fees. He seems to be in it mostly for the adoration of his fans at this point, and to maintain the facade of falsehoods that he built up around himself.

Burzynski is the next level up. He directly harms people, every day. He knowingly orders medications that the patients don't know about he, he massively overcharges them and obfuscates the billing to avoid them learning this, he lies about insurance reimbursement, and he lies about the health and even living status of his patients as he attempts to lure others to their doom. The best analogy I can think of is Dr Brinkley, the "goat gland doctor", because he goes way beyond bad science and dangerous advice. (Brinkley's worse than Burzynski, IMHO. Maybe if Burzynski had the antioneoplastons mixed in NECC's wildly unsanitary conditions it would approach Brinkley's level of evil.)

By Calli Arcale (not verified) on 07 Nov 2012 #permalink

Off topic, but Prop 37 on Genetically Modified Foods failed in California:

http://vote.sos.ca.gov/returns/ballot-measures/

This was the ballot initiative that would have required labeling of anything that might include a genetically modified source. I was actually a little surprised by the result, which was that the initiative lost by half a million votes (out of 9 million cast -- California is a populous state).

I would attribute this result to the fact that a lot of people voted the right way for all the wrong reasons. The anti-37 group raised concerns that ultimately came down to a couple of arguments -- (1) that prop 37 didn't apply to all foods, but only to some -- why is this a problem, if you believe that a good start is a good start?, and (2) that it would have cost money to farmers, markets, and ultimately consumers, including an asserted $400 per year cost per household.

If you look at the county by county vote totals on the Ca Secretary of State website, it becomes obvious where the initiative lost big: The rural and farming areas including the central valley went against it about two to one, as did some of the traditionally conservative urban areas. It was only in the traditionally liberal, urban areas that the initiative was ahead, and this seems to have been based on arguments that people have the right to know what is in their food. The counterargument, that Prop 37 went well beyond a simple right to know, and added an obligation that would have affected all consumers, was ignored.

I suspect that this is not the last time this kind of item will come up. I think that allowing producers such as Whole Foods Market and "organic" farmers to label their products as GMO free, and sell them at a commensurate price, would be an acceptable compromise. The rest of us can continue to buy the usual mix of Roundup Ready corn products and BT resistant cotton tee shirts as we see fit.

Orac's point that the arguments against GMO's are related to other woo (I believe this is a reasonable summary) is well taken. In chatting with people who asked my views, I rapidly figured out that most people are blissfully unaware that DNA is a regular component of human nutrition, rather than something out of a horrror film. To the non-biochemist, the idea of messing with genes in any way is science-fictional. They also are not up on the recent history of genetics and cancer research, and tend to dwell in a 1960s era type of murky thought.

Naive question, but meant sincerely:

Is there a particular reason the FDA lets people such as continue? And scammers such as Hulda Clark who were practicing "medicine" without a license. That's a state issue, but it's in the general class of obvious and deadly scams.

Is it incompetence, indifference, lobbying, something else or simply the way things have always been and always will be?

And
Why are they not in jail?

By Spectator (not verified) on 07 Nov 2012 #permalink

@ Spectator:

Mainly, the FDA doesn't have the resources to pursue them. Their budget is VERY limited, so something has to get pretty large-scale before it gets that much on their radar.

@Spectator

To add to what Beamup said, FDA is really there to regulate the interstate marketing of foods, drugs and medical devices. They can go after someone for marketing a product that is not approved or that is marketed for an unapproved indication. They can go after someone for gross lack of safety of their product by denying/removing marketing approval. They can go after someone for not following current Good Manufacturing/Clinical/Lab Practices in the production/testing/distribution/marketing of a product. What they can't do is go after someone for bad medical practice (state Medical Board's jurisdiction) or marketing fraud (FTC's jurisdiction).

About the worst that FDA can do is to deny Burzynski approval to market his product for interstate commerce, strip him of the right to receive any Federal funding for his trials, or limit or remove his ability to conduct clinical trials.

The fact that people are being actively harmed by his practices got him on FDA's radar. If his impact was along the lines of Kinoki Detox Foot Pads, they probably wouldn't have lifted a finger. Since his treatments are not (yet) actively killing or maiming people at a large scale, FDA probably won't be doing a whole lot beyond warning letters and minor sanctions; there are bigger fish to fry, as it were.

They have limited funding, consequently limited staff resources and need to weigh this against the hundreds or thousands of other problems they need to deal with.

@ Todd:

Since the only way Burzynski can legally scam his victims is by cloaking the "treatments" as "clinical trials," removing his ability to conduct clinical trials would shut him down AFAICT. So they have the regulatory authority to do it - if they had the resources.

@ Bob G:

Correct. And I can hear the shrieking from thousands of miles away!

*Ne plus ultra de* woo, MIke Adams, carries on as per usual @ Natural News today: he says that the measure " was defeated with the use of $45 million in fraudulent advertising and dirty tricks funded by Monsanto, PepsiCo, Coca-Cola, Kellogg, General Mills, DuPont, Bayer and other food and pesticide companies".. even "natural" brands "betrayed consumers".

Similar tripe courtesy of Gary Null at Progressive Radio Network. Both vow that the fight is not over.

@ Spectator:

If only. Governmental agencies and professional organisations don't persue alt med providers who harm customers or cause them to waste money, time and effort the WORLD OVER.
Nutritionists pretend to be doctors in health food/ supplement shops, yoga teachers and exercise teachers prescribe remedies and alt med gurus hold court as consulting physicians on radio and over the internet.
If only SOMEONE would chase these people down.

By Denice Walter (not verified) on 07 Nov 2012 #permalink

True that, Rich Woods. When it comes to quacks they are either well-meaning, delusional tools living a world of confirmation bias, or they're sociopathic charlatans who are deliberately scamming. The difference? One is unintentional manslaughter, the other is murder.

By Glaxxon Pharma… (not verified) on 07 Nov 2012 #permalink

@Shay, as someone who spends a lot of time in the medieval period courtesy of the Society for Creative Anachronism, I know of several practices even better than horsewhipping. Trial by Ordeal, for instance. In Anglo-Saxon times, this could be used in cases of perjury, so it's even applicable to Burzynski!

By Christine (the… (not verified) on 07 Nov 2012 #permalink

Oh, Christine. I'd do it. I'd even offer to play Ivanhoe. I've got a Mameluke sword in the upstairs closet that hasn't been used in years.

Thank you Todd W. That's kind of where I was heading. If studies with children require more/different ethical approval and scrutiny, then studies wouldn't normally combine both kids and adults in one... ?

What they can’t do is go after someone for bad medical practice (state Medical Board’s jurisdiction) or marketing fraud (FTC’s jurisdiction).

Where is the line between marketing fraud (FTC) and marketing for the incorrect indication or unapproved product (FDA)?

Thanks also to Lilady.

@Todd W et al

Thanks for the details, that explains a few things.

As long as attempts to balance the budget exempt the sacred cows which consume 3/4 of spending (retirement and military), actual functions of government will be short-staffed.

By Spectator (not verified) on 08 Nov 2012 #permalink

@flip

I'm not entirely certain where the division between FDA and FTC is. There does seem to be a bit of overlap.

We can at least pull the curtain back a bit to show him sitting in his smoking jacket, looking at himself in lovingly with a gilt hand mirror, delivering his Nobel acceptance speech for the thousanth time.

Except he knows that antineoplastons are a scam and that he’ll never be awarded any form of scientific or humanitarian recognition.

I'm not so sure. The part about him knowing, that is. A lot of conmen seem to fool themselves as well as their marks - L. Ron Hubbard actually wrote to the military asking them to confirm the 22 medals he earned in WWII, IIRC, when he would have been fully aware that he earned only four.

By Antaeus Feldspar (not verified) on 08 Nov 2012 #permalink

Thanks Todd. I guess I've got some homework to do...

Thanks Lilady!

@lilady

Heh...and that's just one part of FDA. There's still CBER, CDRH and CFSAN. Oh, and CVM, for veterinary medicine.

@Antaeus Feldspar,
It's my long-standing opinion that fraud in scientific research usually appears to be driven by sincere belief in some element of what the fraud is supposed to prove, with monetary gain being a secondary consideration at best. I believe the pattern holds consistently where the perpetrator actually holds professional credentials, but self-declared "doctors" COULD be another matter. It's my understanding that there is, in fact, some question about how or if Burzynski eared the title of "doctor".

A further consideration is that Burzynski can't be managing his operation alone. He might not, in any meaningful sense, even be in charge. Depending on how much he is relying on "support" from others day to day, it seems quite possible that he is insulated enough from the happenings at his clinic to sustain a real belief that his treatments work.

David N. Brown
Mesa, Arizona

By David N. Brown (not verified) on 09 Nov 2012 #permalink