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.