About three months ago, I was displeased to see in a normally reliable source of medical news (STAT News) a story about a patient of cancer quack Stanislaw Burzynski, Neil Fachon, that fell victim to every trope that Burzynski’s used for 40 years to present himself to the press as a “brave maverick” doctor and researcher rather than the unethical quack that he is. Basically, as was the case of so many similar stories in the 1990s and more recently, the story was framed as one of a desperate patient battling the FDA to save his life, instead of what the story really represented was a desperate patient being taken advantage of by a man who was once a promising physician-scientist who, obsessed with amino acids he found in the blood and urine of patients that he thought were part of the body’s natural anti-cancer defense system, turned into a quack back when disco ruled.
As I pointed out at the time, we’ve been down this road many times. A young adult or a child is diagnosed with a brain tumor like the one Fachon was diagnosed with or some similarly deadly cancer. The patient usually (but not always) undergoes conventional therapy that, predictably, fails and ultimately finds out about Burzynski. That patient then overcomes all obstacles, be they financial or the FDA to reach the Great Man and undergo his magical ANP therapy. In general, the main obstacle is financial, hence the stories of Burzynski patients raising hundreds of thousands of dollars to obtain ANPs. Credulous journalists would then do stories very much like the STAT News story about Neil Fachon, spinning the story as a tragic but hopeful tale of a brave young person battling all odds to obtain the one treatment that might save his or her life. It has become such a common trope, stretching back at least 20 years, in stories about Burzynski patients, that four years ago I referred to it as “kind-hearted strangers and the failure of medical journalism.”
Well, STAT News went a long way towards making up for its previous travesty of a story. Even better, it was one of the two journalists who screwed up so badly before, Sheila Kaplan, who did the redeeming with a story entitled To help cancer patients, lawmakers pushed access to a controversial doctor. In the process, she revealed that Burzynski has used Texas’ new “right to try” law to bypass the FDA on at least one occasion, validating my many warnings that such laws are custom made for a quack like Burzynski. Over the five years or so that I’ve been writing about Burzynski, the lack of science behind his continued belief in antineoplastons, and how he exploits patients with terminal cancers to sell them false hope that antineoplastons might save them even though even the best evidence Burzynski can come up with shows that they don’t work against any known cancer, I’ve frequently pointed out how powerful legislators have run interference for Burzynski, either by pressuring the FDA to lay off, as Rep. Joe Barton (R-Dallas) did in the 1990s by dragging then FDA director David Kessler in front of his committee to torture him over the FDA’s prosecution of Burzynski for administering unapproved drugs. That’s just one example. As part of that political theater and ever since, Burzynski has encouraged his patients and fans to contact their Senators and Congressional Representatives to put pressure on the FDA, and apparently they’re still at it, as Kaplan documents:
From 2011 to 2016, 37 members of Congress wrote to the FDA about Burzynski, several of them numerous times, according to documents obtained by STAT under the Freedom of Information Act. Most of the lawmakers asked the agency to grants constituents “compassionate use exemptions” so that they could try his unapproved drugs, or to allow his clinical trials to proceed.
Burzynski told STAT that the “interventions by lawmakers were helpful.”
Not coincidentally, this time period corresponds to the time when critical news stories first started being published in the blogosphere when one of Burzynski’s employees, a contractor named Marc Stephens hired for SEO and to improve Burzynski’s web presence, issued legal threats against Rhys Morgan, a British teenager (at the time) and skeptic who had written critical blog posts about Burzynski and his recruitment of patients from the UK to feed his Houston clinic. This same employee also started threatening other skeptics, and ultimately the embarrassment became so great that Burzynski was forced to disavow him. It then encompasses the time period when the FDA put a partial clinical hold on Burzynski’s clinical trials (more on those trials later) in the wake of the death of a six year old child named Josiah Cotto due to severe hypernatremia (too much sodium in the blood, a common sequelae of ANP administration) and then inexplicably lifted it. More recently, the Texas Medical Board initiated action once again to strip Burzynski of his license to practice medicine, a case that is still ongoing. Basically, Burzynski has been under siege for five years now, and when he’s under siege, as he was in the 1990s, his first move is to try to apply pressure to lawmakers to apply pressure on the FDA.
The revelation that Burzynski knows how to get his patients and fans to apply pressure to patients was not really anything new, although the detail and the description of how widespread it was is useful information. The real revelation, which confirms something I’ve been warning about since “right-to-try” laws that I’ve been so critical of started proliferating like so much kudzu until 31 states have them and started to really fear after Texas passed its very own right-to-try law last year. Given that I just wrote a long post about right-to-try last week, I don’t want to go into too much detail about such laws again other than to explain that such laws claim to allow terminally ill patients the “right to try” experimental therapeutics that have passed phase I trials and are still undergoing clinical trials, although it also indemnifies the physician recommending the treatment and the manufacturer of the drug or device from liability if anything goes wrong and provides no financial assistance to patients, making it something only the rich will likely be able to take advantage of. Anyway, if you want a detailed description of why right-to-try is such a cruel sham, check out this post, or this post, or this one.
Unfortunately, the revelation that Burzynski is using right-to-try bypass the FDA is buried in a very short passage in Kaplan’s article about how appeals to the FDA to allow patients to access antineoplastons through the FDA’s Expanded Access/Compassionate Use program don’t always succeed:
The appeals don’t always work. In the 5-year-old’s case, for example, while waiting for the FDA to make a decision, Burzynski said he used a Texas state law to circumvent the agency and start treatment.
What was that state law? What could it possibly have been other than Texas’ right-to-try law, which is basically a blank check for Burzynski? Here’s what I said about Burzynski the very first time I wrote about right-to-try:
In other words, these “right to try” laws are nothing but feel-good placebos. They have no real effect because reputable pharmaceutical companies will not cross the FDA by providing an investigational drug to patients without a proper IND. That means that they only companies that might take advantage of “right to try” laws would be disreputable companies like Stanislaw Burzynski’s institute. Like Burzynski, “right to try” laws offer nothing to cancer patients but false hope. In fact, I’m hard-pressed to think of anyone whom these laws would benefit other than Burzynski, which makes me wonder if his minions have anything to do with promoting them.
Of course, in fairness, I have to point out that, among cancer quacks, Burzynski is in a unique situation in that his antineoplastons meet the criteria for right-to-try. They passed phase I studies, and he still has registered clinical trials testing them registered with the FDA. Given Texas’ right-to-try law, he can basically do as he pleases—for now. After all, if his clinical trials of antineoplastons were ever to cease, they wouldn’t be eligible for right-to-try any more. So Burzynski has to walk the proverbial tightrope. He can’t just use right-to-try willy nilly as often as he likes to maximize profit because he would (1) deprive his sham clinical trials of patients and (2) risk finally alienating the FDA enough to finally pull the plug. To be honest, though, given how irresponsibly the FDA has behaved in reinstating Burzynski’s clinical trials, which were designed to get around his prosecution in the 1990s and allow him to continue to administer antineoplastons (details here), even after the death of a child, I don’t think Burzynski has much to worry about here, particularly given all the legislators advocating for patients to the FDA, as described by Kaplan:
The congressional interventions have come from Republicans and Democrats alike. Besides Yoho, Texas Republican Senators Ted Cruz and John Cornyn, and New Hampshire Senators Jean Shaheen (D) and Kelly Ayotte (R), among others, have advocated for Burzynski’s treatment for their constituents.
Representatives Doug Lamborn, a Republican from Colorado, and Carol Shea-Porter, a Democrat from New Hampshire, who has left Congress, and Joe Pitts, the Pennsylvania Republican chairman of the House health subcommittee, among others, have also pushed the FDA to grant constituents access to either Burzynski’s drugs or one of his clinical trials.
One wonders if Burzynski had some influence on some of the legislation Sen. Ted Cruz proposed last year. I understand that lawmakers listen to their constituents and often try to intervene when they are having problems with a federal agency, but many of these lawmakers fell prey to the same false hope that was driving patients to contact them. I must admit that I was happy to learn that one of my Senators, Sen. Debbie Stabenow (D-MI), has instead been listening to the mother of a patient victimized by Burzynski:
Sandy Smith wishes they would stop. In 2007, her son Andrew was being treated at Burzynski’s clinic for DIPG — or diffuse intrinsic pontine glioma, a rare form of cancer that attacks the victim’s brain stem.
Anxious about his progress, Smith began looking into the cases of other children treated there for the same cancer. They had all died.
She and her husband Shawn pulled Andrew out of the clinic and eventually brought him to the National Institutes of Health. Andrew lived another two years, an unusually long amount of time for a child with a DIPG diagnosis, and longer than any child who stayed with Burzynski survived.
On the fifth anniversary of Andrew’s death, aware that Burzynski supporters were claiming in widely distributed promotional materials that an upcoming trial would cure 1 out of 3 kids with DIPG, and fearing for those children’s safety, Smith wrote to one of her senators, Michigan Democrat Debbie Stabenow. She asked Stabenow to pass along the record of Andrew’s experience to the FDA.
Stabenow did so, and the FDA called Smith. She hopes their conversation gave the agency ammunition in its long battle with Burzynski. She believes that lawmakers who don’t fully understand what is happening in the clinic, and push for participation, do a disservice to their constituents.
It turns out that Smith, who has said she felt misled by Burzynski, who washed his hands of her son after he developed major complications. (Sound familiar?) Their family had also spent $24,000 in two weeks in Houston, which was more than her husband, the minister of a small church, made in a year, having raised the money from donations from other churches.
I’ve learned on social media that the Goldwater Institute claims to know of 40 or more patients who have received experimental drugs through right-to-try, although its executive VP, Christina Sandefur, denies that she knows of any Burzynski patients utilizing right-to-try. Kaplan’s article shows that Burzynski is using right-to-try, just as I predicted he would. I don’t know if it’s just this one patient, but I’d be willing to bet it’s more than that. Right-to-try is just the tool he’s been waiting for to keep his antineoplaston business from folding.
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Gee, can one enjoin the right to try on him?
I'm thinking of hung, drawn and quartered.
Although, perhaps I'm just thinking mercifully.
and when someone asks that he "right to try" extends to human sacrifice? I mean shouldn't I have the right to try to cure my disease by eating the still-beating heart of one of my enemies captured during battle?
And shame on the politicians who helped shape this law.
@2
Seriously you think equating the right for a terminally ill person to try a compound which has past phase 1 clinical trials to the right to deliberately kill another person?
I read it as sarcastic imagery of the slippery slope that right-to-try laws are.
@Mike: I agree with Science Mom's interpretation of Zach's comment. He was taking the thought process behind right-to-try laws to its logical extreme. Many cultures in the past have practiced human sacrifice, whether of virgins or of captured enemy warriors. These sacrifices have not been shown to be less medically effective (for people other than the victim) than antineoplastons. On the contrary, Burzynski's patients end up just as dead as the sacrifice victims; the former group just take longer to die.
Erm, I had Zach pinned immediately.
But then, I'm the Emperor of hyperbole in extremis to make a humorous point, recognized by nearly all.
But then, I go so far overboard, it's beyond obvious what's going on.
It's argumentum ad absurdium, taken a bit pale, likely due to inexperience in the method. ;)
I'm very good at the absurd, one look at my face proves that. ;)
A face better made for radio does not exist.
Shit! My nose just protruded through the damned monitor.
Did I mention *why* my eyes are brown? ;)
Zzzzzzzzzzzzzzzzzzzt!
Just as a heads up, final arguments have been submitted in his case, and the judges have about 40 more days to go through the 75,000 pages of documents to come up with their findings. Those will be passed along to the Medical Board for a final ruling. The TMB absolutely crucified him over billing practices. There are so many aggravating factors that I find it hard to believe that he would have a license this time next year.
"I have never heard of antineoplastons," said Yu Xiong, deputy president of the Shanghai Institute of Pharmaceutical Industry.
http://english.sina.com/life/2012/0202/436685.html
"“I have never heard of antineoplastons,” said Yu Xiong, deputy president of the Shanghai Institute of Pharmaceutical Industry."
Oddly, I have. alas, we're speaking of something far from your capabilities in physics, as they're farking antimatter.
Hence, dude wants to destroy a state sized area at a minimum, to "cure" the incinerated patient.
I'm of of using an effector field on him, but I'll let Special Circumstances handle him.
You all went off of the control list once we learned of the sublimed returned in your midst and the open invitation from said individual.*
*Ya gotta read Ian Banks The Culture series to get a hint.
Burzynski should publicize his formula. This way, anyone willing to milk a stallion could create, and self-administer his potion. A liquid chromatography column could effectively separate the antineoplastons from the rest of the horse-pee no doubt.
No special law required this way.
I am all for medical choice, but I am willing to bet that there are more effective alternative cancer treatments than this. There are many to choose from. Burzynski charges quite a bit of money for simple polypeptides.
Oh, Ted, they are MAGIC polypeptides.
As I have noted on previous threads about Burzynski, the fact that he doesn't do anything like this is a significant tell. If I really had something I thought was a major medical breakthrough, I would publish the finding in the literature, or at least file a patent application and license it to somebody who could scale up the production process. Burzynski has not done this. Instead, he is behaving more or the less the way I would behave if I were attempting to run a con involving a purported medical treatment: charge the suckers^H^H^H^H^H^H^Hpatients large amounts of money for the treatment, and keep all production in house so that the only way they could get it would be through my clinic.
@ Eric Lund
As it turns out, he has filed a patent for antineoplastons. The main peptide mentioned is 3-[N-phenylacetylaminopiperidine]-2,6-dion and is separated from the urine using a liquid chromatography:
"According to one sequential separational process, the urine ultrafiltrate is acidified, filtered again, and subjected to high performance liquid chromatography employing a silica gel C-18 column. The fraction detected and collected as refractive index peak after elution with 450 ml water is referred to as antineoplaston fraction A1."
Each subsequent antineoplaston [a2-a5] is so named by progressive iterations of chromatographic separation.
Catherine the Great.
https://en.wikipedia.org/wiki/Legends_of_Catherine_the_Great
Lol, because size does matter.
From the link #8 Mark Thorson provided
Wang Youzhi, director of the inspection department of the Shanghai Food and Drug Administration, said advertisements for phase-two trial drugs are forbidden in China, and the drugs can be treated as counterfeit medicine if they are found to be sold on the market.
It looks like Wang Youzhi is saying that this may be a criminal offence. Perhaps we can look forward to Burzynski being extradited to China?
And this is also why I always feel so conflicted when I see posts about various online fundraisers (GoFundMe etc) for kids with cancer. I feel terrible for the child and their family, but way too often the treatment they are trying to pay for is total quackery.
RI's primary weapon is public discussion. RI should continue to try to attract and educate B patients that have legit claims on malpractice and / or fraud. Removal of more patient rigthts is not my idea of desired success.
Drug restrictions drive the problems to drug access and crazy pricing. Having been on the (non)receiving end of this, I'm sure that US citizens have been routinely deprived of cheap generic drugs that could save, substantially prolong or enhance their lives.
The US and states need to come up with measures that account the businesses but at least preserve the individuals' rights. Right now, We the little people are infringed, mistreated, untreated and overcharged by "proper" medicine due to FDA and state restrictions that yield a lot of medical problems and high prices. "Right to try" is merely a sideshow.
All else is tongue clucking while you step on our faces.
@prn #17: if you're unhappy about drug prices, you'd do better to point your ire at the patent system (which is broken and no one disputes this) than the FDA. It's the 7 year period of exclusivity that allows supply and demand pricing that keeps drug prices so high.
Panacea@18
I do think patent medicine prices and serial patents with extensions can certainly be abusive, that's the business.
However it's the ridiculously priced or unavailable generics that kill or deprive more people for higher % margins and simply unearned premiums. In fact, over priced, unused or unavailable generics help drive the patent medicines' price premiums.
Then part of the problem would be bribes and contributions from pharmaceutical representatives to prescribing doctors. The effect of course would be MD's having a bias for prescribing the more expensive option.
When human sacrifice passes the phase 1 trial and is approved for further trials, we'll talk.
Sciencebasedmedicine.org has degenerated. This is what the moderator has to say about Baylor: "Yes but Baylor is a naturopathy school, they are morons."
You are conflating two different problems. Yes the business end of the pharmaceutical industry, particularly in the U.S. is (to be charitable) is less than good and many inexpensive, effective drugs are not on the market. However, people need to be protected from snake-oil and dangerous, inadequately tested drugs/devices which yes (much to your chagrin) are "alternative remedies". These are not mutually-exclusive.
Ted @ 22, why don't you raise your concern there then?
@Science Mom is a misnomer
Why don’t you go eat some PurinaChow® you rat.
Fendelsworth why do you keep giving yourself away.
Hello, Travis aka Fendelsworth. Still working on your identity issues? I see your most recent personality, Squiggles, was recently banned from SBM.
Cripes, I killfiled it almost immediately. I find it strange that others are seemingly slow to pick up on the routine.
Chris, he's also Ferbie Blerbigus, Erik and of course Lord Windemere. Given the content of his comments, I'd say identity issues are the least of his worries.
Well you are preternaturally good at that. I had my suspicions but didn't want to get caught up seeing Fendelsworth everywhere without a clear sign.
It works both ways: in many cases US citizens have to buy the generics rather than the name-brand medications. This is because insurance providers, which like pharmaceutical manufacturers are corporations and therefore want to maximize profit, will try to spend as little as they are allowed to get away with, just as other players in health care will try to charge as much as they are allowed to get away with. Many people loath insurance companies as much as or more than Big Pharma, and justifiably so, as insurers have a reputation for screwing their customers (PPACA has helped that situation somewhat, but not eliminated it).
The patent system exists for a reason: it allows inventors (including pharmaceutical companies) some assurance that they will be able to profit from their inventions (new drugs, in this case). It costs money to develop a new product, and a for-profit company won't make the effort if somebody can sell a cheap knock-off a week after their painstakingly developed product comes to market. Yes, there are issues with the patent system--the precise tradeoffs we are making are often far from ideal. But we have to make some tradeoff if we want to have new drugs in the future.
Where the FDA comes into all of this is that they have a system that is designed to make sure any new drugs on the market are safe and effective. These rules exist because, in the old regulatory regime, many people were killed or injured by drugs that were not safe, e.g., thalidomide. That's a general truism for a lot of government regulations in a lot of fields: they exist because people died without them. You can make a case that the FDA approval system needs some tweaks. But "right-to-try" is a poor choice, because it opens a loophole big enough for Burzynski's mansion to fit. Of course he's going to take advantage of this loophole.
Science Mom is Fendlesworth!
Still waiting for Chris' idiotic Rawhide parody...
Science Mom, my excuse was I was barely paying attention to this thread. Oh, lookie! He is pulling the "put-name-here is Fendelsworth" routine. He tried that recently at SBM.
Well, I have been falsely accused of being Fendlesworth before, and it always ends in a ban. Whenever I start talking about certain issues someone screams "Fendlesworth", which is as far as I can tell, a code-word for "ban".
Do any of the "right to try" laws have monitoring provisions for keep tabs of what diagnoses and what "right to try" treatments were tried (while still respecting patient confidentiality, of course)? Since Burzynski is the only quack using antineoplastons, such a monitoring provision would provide info as to how often he's using this law fill his coffers and coffins.
"I get banned when someone recognises me but it's not me even though I just said it was." Blimey.
Science Mom: "Blimey."
It is like he can't even remember the previous incidences when he pulled the same stupid stunts.
Well, I have been falsely accused of being Fendlesworth before, and it always ends in a ban.
Brilliant.
I didn't really care one way or the other; quick isomorphism on the horizon was good enough.
I refuse to believe even Fendelsworth could be this clueless, so have to applaud the creature for self-poe well executed.
But, for the sake of spoiling the joke conversation, which ones were you, rather than Fendlesworth?
Yes, your repeated and ubiquitous habit of recommending dog food for human consumption must be stopped!
Or maybe it's your silly temper tantrums and what you (and only you) no doubt assume are "snappy" retorts.
Or maybe, just maybe it's just using sock puppets.
@ChrisHicke
nope, no monitoring provisions.
There is a back story here of which I am unaware, but I do know that sockpuppetry is one of the few offenses for which Orac will drop the banhammer. And I agree that the poster whose 'nym is derived from the protagonist of Airplane! (the one with the "drinking problem") was over the line in comment #25, which to me seemed to come out of left field.
@ Eric, Ted Striker=Fendelsworth, Annabel, Michelle and numerous other 'nyms on Discus. He's a particularly obnoxious troll who got his ickle fee fees hurt on another blog when he fell short of defending the infamous Petrik et al. aluminium/Gulf War Syndrome "study". I suppose he thinks that's a clever insult or somesuch.
@12
Quote from Eric Lund @12 : "..... If I really had something I thought was a major medical breakthrough, I would publish the finding in the literature, or at least file a patent application .........Burzynski has not done this....."
Really ? Even a basic search of the US Patent Database shows that Burzynski has around 20 patents in his name starting from the 5 February 1982 and the last one 2005
These are the links to just four od them:
LINK 1 :
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u…
LINK 2:
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u…
Link 3 :
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u…
Link 4 :
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u…
"Christina Sandefur, denies that she knows of any Burzynski patients utilizing right-to-try" Goldwater Institute makes statements about Right to Try access, but not one state requires that request in any way be filtered or channeled through the Goldwater Institute. And telling them would likely be a violation of HIPPA. So, why would anyone give them credit for knowing whether someone has gotten access to anything, in any state, through the program???
I am in favour of "right to try" laws, but *also* in favour of them having a mandatory no-charge clause... Patients are free to try and companies to supply - provided they don't get a penny for the drug, only the clinical data.
I am sure a lot of companies will be significantly less interested in fighting for "patient rights" in those circumstances.
It would seem to me this wold lead to patients and their advocates lobbying for increased delay in approving new drugs in order to increase the time period in which they must be provided free. This would then induce the pharmaceutical companies to hide their research on new drugs, lest they cannibalize their old drug sales.
Head over to Popehat if you haven't been paying enough attention to Bob Blaskiewicz.
I'm sad to say I just saw on Twitter that Burzynski patient and one of his most militant supporters, Sheila Herron, has died.
I couldn't find any newspaper obituary online but I did find that a Tacoma-area death certificate was filed in her name on Sept. 26. You have to request copies of the certificates from the records department, they're not posted online.
I had a feeling something was wrong as her Twitter account had been inactive for the past three months. She had been a regular contributor, posting several Tweets a week regularly.
She was the person who reported Orac to authorities for one of his columns deconstructing her (public) claims about Stan's success.
I wonder how long it will take for the Burzynski PR websites to acknowledge her death?
(Of course she may have been hit by a bus and her death had nothing to do with her cancer...)
Of course even it was the cancer that recurred and killed her, Burzynski apologists would just spin it to say that the ANPs extended her life and allowed her to travel the world and enjoy her favourite bands (and support Trump) after the mean oncologists and Big Pharma "sent her home to die" something something something.
Any chance it might have been the conventional treatment she received (as described by Orac) that bought her those extra years and Stan's ANP's did nothing (except cost her lot$)?