One common theme that has been revisited time and time again on this blog since its very founding is the problem of how science and medicine are reported. For example, back when I first started blogging, years before I joined Science-Based Medicine in 2008, one thing that used to drive me absolutely nuts was the tendency of the press to include in any story about vaccines an antivaccine activist to “tell the other side” or for “balance” to the story. So in a story on vaccines, on one side you would have Paul Offit, a bona fide, legitimate vaccine expert, and on the other side you would have J.B. Handley, Jenny McCarthy, Andrew Wakefield, or a lesser light of the antivaccine movement. This same trope included stories about autistic children in which a reporter does a human interest story about a family struggling with raising an autistic child in which he lets the parents spout antivaccine misinformation, providing only a brief token quote by a scientist for “balance.” Thus, whether they intended it or not, the reporter would let the emotional impact of the story serve as persuasion to believe the parents’ antivaccine views. So, even though there was not (and hasn’t been at least since 2001 or probably much earlier) anything resembling legitimate scientific controversy over the question of whether vaccines cause or contribute to autism, the press aided the antivaccine movement in keeping alive the appearance of a controversy. It was, as I like to call these things, a manufactroversy, a controversy manufactured by the antivaccine movement to give the appearance of an actual scientific controversy. It’s a time-dishonored journalistic failing that is still a major problem with reporting on, for example, anthropogenic global climate change and genetically modified organisms (GMOs).
Sometimes, however, the press is teachable. A few years ago, after already having blogged about vaccines and autism for several years, I started noticing fewer stories with false “balance” and more stories that simply treated the antivaccine movement like the fringe movement it was, either not bothering to mention it or, if it had to mention it, basically letting scientists explain why it’s bad science and dangerous to public health. These days, false balance and stories that are antivaccine propaganda are relatively rare, aside from stories by fringe journalists like Sharyl Attkisson and Ben Swann. That’s a good thing. Unfortunately, I wish I could say that I really believe it was due to the efforts of skeptics and science advocates more than it was due to the discrediting of a major antivaccine figure, Andrew Wakefield, but even six years after Wakefield lost his medical license and saw his infamous 1998 Lancet paper linking the MMR vaccine to bowel disease in autistic children (the one that ignited the MMR scare in the UK) retracted, I’m not entirely sure. Be that as it may, there still remain blind spots in the press.
One of these blind spots, it would seem, is Stanislaw Burzynski. I can understand why his story might still be a blind spot. It’s nowhere near as big as the whole vaccine-autism or anti-climate science manufactroversies. Being a niche story that not a lot of people know about, it’s a hard one for us to educate journalists about. Be that as it may, I saw just such an example of false balance in the form of a credulous human interest story featuring Burzynski’s cancer quackery in the same way that a lot of stories about autistic children were done ten years ago. It’s a story by Bob Tedeschi and Sheila Kaplan for STAT News (usually a fairly reliable source of medical news but one that’s slipped up recently) entitled He’s 20. Has brain cancer. And is caught in the crossfire between the FDA and a renegade doctor. It’s about a very appealing, brave, and unfortunate young man named Neil Fachon:
The dizziness didn’t much worry Neil Fachon. Neither did the double vision. He was recovering from concussions he had sustained while playing sports, and the symptoms weren’t enough to keep him from his engineering classes at Northeastern University in Boston.
Then came some inexplicable struggles with handwriting and swallowing.
Doctors scheduled an MRI. On March 4, his life came unhinged.
If you’re a regular reader of this blog and have read some of my posts about Stanislaw Burzynski, you can guess what’s coming next. Fachon was found to have a brainstem mass that turned out to be diffuse intrinsic pontine glioma (DIPG), a form of brain cancer that’s usually inoperable when discovered because of its connection to the brainstem. Unfortunately, a diagnosis of DIPG is more or less a death sentence, although there are rare long term survivors, contrary to Burzynski’s claim that there are no cases of anyone surviving DIPG in the medical literature—other than some of his patients, of course.
I can only imagine what Fachon and others with the same diagnosis go through, the desperation they feel. From the comfortable “old” age that I’ve achieved, I can’t imagine what it would have been like at that age to face such a fate. I wouldn’t have graduated from college, wouldn’t have become a physician, wouldn’t have gotten married, wouldn’t have become a scientist, wouldn’t have achieved my minor notoriety as a blogger. You get the idea. I can understand why a young man of 20 would want to try anything to have a shot at all those things.
Unfortunately, so does Stanislaw Burzynski.
Burzynski’s been a fairly frequent topic on this blog ever since I really became aware of him in 2011. For details, you can learn all you need about Stanislaw Burzynski from my article in Skeptical Inquirer, Stanislaw Burzynski: Four Decades of an Unproven Cancer Cure, and Bob Blaskiewicz’s article Skeptic Activists Fighting for Burzynski’s Cancer Patients. There has also been some excellent reporting on Burzynski, including the USA TODAY feature by Liz Szabo, a segment on the long-running BBC News program Panorama, and a recent NEWSWEEK article by Tamar Wilner. Then there’s The Other Burzynski Patient Group, which tells the tales of patients who died after having been taken advantage of by Burzynski. These resources, which show up in Google searches, are part of the reason that to me there’s no excuse for STAT News publishing an article like the one under discussion. There’s so much easily available on the web telling the ugly story of just how Burzynski has operated over the last 40 years and, in particular, since the late 1990s. A simple Google search is all it takes.
Be that as it may, the CliffsNote version of the infuriating saga of Stanislaw Burzynski is as follows. Burzynski is a Polish expat who, by the accounts we can find, was a promising medical student. In 1970, he fled his native country to the US in order to avoid being inducted into the Polish Army as a result of his refusal to join the Communist Party. Arriving with only $20 in his pocket, he stayed with an uncle and eventually got a job doing research at the Baylor College of Medicine, where he became interested in endogenous substances that prevented cancer. During that time, he discovered what he later dubbed “antineoplastons” (ANPs) substances isolated from the blood and urine that appeared to have antitumor activity in cell culture. So far, so good. There was nothing out of the ordinary, and by the mid-1970s Burzynski appeared to be a promising medical researcher. Then something went wrong.
It didn’t take him long to “go rogue” and start treating cancer patients in his private clinic with ANPs beginning around 1976. Since then he’s been in near-constant battles with medical authorities as he built an empire based on treating the most hopeless cancer patients with ANPs, particularly patients with brain cancer. There were multiple attempts by the Texas Medical Board to remove his medical license. In the 1990s, Burzynski was facing prosecution for insurance fraud, but, as the result of a judge’s ruling, was allowed to continue to use ANPs as long as that use was part of an FDA-sanctioned clinical trial. So, as Burzynski’s then-lawyer Robert Jaffe put it, ““If the judge wants clinical trials, we’ll give him clinical trials.” So that’s just what they did. As further described by Jaffe:
The CAN-1 protocol had almost two hundred patients in it and there were at least a dozen different types of cancers being treated. And since all the patients were already on treatment, there could not be any possibility of meaningful data coming out of the so-called clinical trial. It was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment. The FDA wanted all of Burzynski’s patients to be on an IND, so that’s what we did.
As a result:
CAN-1 allowed Burzynski to treat all his existing patients. That solved the patients’ problems, but not the clinic’s. A cancer clinic cannot survive on existing patients. It needs a constant flow of new patients. So in addition to getting the CAN-1 trial approved, we had to make sure Burzynski could treat new patients. Mindful that he would likely only get one chance to get them approved, Burzynski personally put together seventy-two protocols to treat every type of cancer the clinic had treated and everything Burzynski wanted to treat in the future.
That’s basically been Burzynski’s modus operandi since 1997: Enroll desperate cancer patients on his bogus clinical trials and charge them huge “management fees” without charging for the actual drug itself. Thanks to word of mouth and rumor, not to mention two deeply deceptive propaganda films disguised as documentaries by Eric Merola, Burzynski built up quite a following, with dying cancer patients from all over the world wending their way to Houston, often after having raised huge sums of money to pay for the treatment by various means, including celebrity assistance, from kind-hearted individuals. Through it all, he managed never to publish the results of any of his clinical trials until recently, and, not surprisingly, they showed deeply unimpressive results; basically there’s no good evidence, even 40 years after Burzynski started peddling ANPs, that they have significant anticancer activity. Meanwhile, patients who put their hope in Burzynski die just as surely as they would have if they hadn’t.
In the interim, Burzynski grossly abused the clinical trial process, in particular with his deeply unethical practices. Also part of his MO has been to use sympathetic cancer patients as shields whenever the Texas Medical Board, the FDA, or other governmental authorities try to shut him down, having them show up and proclaim either that Burzynski saved their lives or that they will die if Burzynski’s operation is shut down. Because, thanks to the hype and Burzynski’s blandishments, these patients really believe they will die without him, they are very, very convincing. They’re trying the same thing at Burzynski’s ongoing hearing in front of the Texas Medical Board.
It’s an effective technique, too. A few years back, when 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), led the FDA to put a partial clinical hold on Burzynski’s clinical trials, it was in part the lobbying of patients that apparently persuaded the FDA to back down and reinstate Burzynski’s trials.
It doesn’t help that over the years Burzynski patients have been featured in articles like the one by Tedeschi and Kaplan that use the lazy trope of the brave patient fighting the system and doing whatever it takes to gain access to the only therapy that might save his life. (Never mind that in this case it won’t.) We’ve been down this road before with Burzynski many times. The story usually takes a variation of the form used by Tedeschi and Kaplan: A young adult or a child is diagnosed with DIPG or some similarly deadly cancer. The patient usually (but not always) undergoes conventional therapy that predictably fails, after which the family ultimately finds out about Burzynski. That patient then overcomes all obstacles, be they financial, government interference, or whatever, to reach the Great Man and undergo his magical ANP therapy. In general, the main obstacle is financial, hence the stories of Burzynski patients going to great extremes to raise hundreds of thousands of dollars to obtain ANPs. Examples include Chiane Cloete, whose family was “hoping to raise £130,000 to send her to a US clinic which could be the only chance of saving her life”; Billie Bainbridge, whose family raised hundreds of thousands of pounds and got celebrities involved to see Burzynski’s care; and Rachel Mackey. All were young. All had families who managed to raise prodigious sums of money to go to the Burzynski Clinic. All died. But before they died, credulous journalists did stories very much like the STAT News story about Neil Fachon, spinning the story as a tragic but hopeful story 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 it was referred to as “kind-hearted strangers and the failure of medical journalism.”
Nor is Tedeschi and Kaplan’s story about Fachon by any means the first story about a young person battling for his life but not being allowed to access ANPs because of the FDA. When the FDA placed its first partial clinical hold on Burzynski’s trials in 2013, there were a spate of stories about children with brain cancer who couldn’t access ANPs because of the “cold-hearted” and excessively bureaucratic FDA; e.g., Mackenzie Lowe (complete with video) and Liza Cozad. In Fachon’s case, the obstacle to be overcome is not financial, but the framing of the story is very similar to that of those stories out of the British press. Thanks to the failure of the FDA and Tedeschi and Kaplan’s failure to dig deeper and provide actual context, Fachon’s story is framed as a battle against the FDA using the same sort of frame as advocates of “right to try” legislation do. Worse, they do exactly what reporters did with the vaccine-autism link, “balancing” the story of a very sympathetic, suffering person who believes in an unscientific treatment with the facts and science of the treatment shaded in a way to leave open the plausibility that it might work. Thus, we see statements from Fachone and his family plus claims of evidence of efficacy taken at face value interspersed with statements from scientists about ethics and the lack of evidence for ANPs plus a dispassionate description of Burzynski’s battles against the FDA and Texas Medical Board.
Science and evidence never had a chance.
Yes, the story is factually accurate, but the impression and message it leaves are profoundly misleading. For example:
Despite his record, the Food and Drug Administration authorized Burzynski to run a clinical trial of his treatment on a brain stem tumor. The clinical trial meant the family would not have to pay for the treatment, which can run in the tens of thousands of dollars and is not covered by insurance.
In mid-April, Neil became the one and only patient enrolled.
The Fachon family, who live in East Greenwich, R.I., had read critiques of Burzynski’s treatment on the websites of the National Cancer Institute (which says there’s no known benefit), and Memorial Sloan Kettering Cancer Center (which says it could be useful as a supplemental therapy for breast cancer). They’d read testimony, too, from Burzynki’s many impassioned, though less credentialed, fans. Neil and his sister, Evie, a senior at Northeastern, had even held a Skype conversation with a woman in Argentina who credited Burzynski with curing her fatal brain tumor.
Everyone was shocked when the FDA abruptly ordered the trial shut down, without making public the reason. The agency reversed course just as abruptly, and just as mysteriously, last week, after the Fachon family filed their lawsuit. A federal court order dated May 27 indicated that the FDA would let Neil Fachon continue his therapy.
“I can’t put into words the stress and the mental trauma that the FDA put us through,” Wendy Fachon said. “How they treated us was absolutely abysmal.”
I understand completely why Ms. Fachon might feel that way. I really do. In reality, what the FDA was doing was to try to protect her son from exploitation by a quack, a con man, to protect him from subjecting himself to risk with no potential for benefit. That’s what the FDA is there to do.
I have actually been meaning to blog about this story for a while, as I did see news reports nearly two weeks ago in which US District Court Judge John J. McConnell, Jr. ruled that the “Defendants [FDA] are restrained and enjoined from interfering with this treatment for Mr. Fachon until a full hearing on a preliminary injunction takes place. The Court finds that there is a likelihood of success on the merits because Mr. Fachon has a liberty interest in continuing to receive a drug addressing his life-threatening disease that the FDA had previously allowed him to receive.” Of course, there is no good evidence that this drug actually addresses the life-threatening disease of Neil Fachon—or anyone else, for that matter. It also strikes me as a very dangerous precedent for a federal judge to overrule an FDA decision, as such rulings are seldom made based on science.
In fairness, though, I can see one point that the judge made, namely this: The reason the FDA shut down Burzynski’s clinical trial in April 2016 was on the basis of an inspection of ANP manufacturing facilities in March 2015, a delay that Judge McConnell characterized as “extraordinarily long and unexplained.” He not unreasonably wondered why the FDA took no action during the 13-month period between the inspection and the placing of a hold on the clinical trial in which Fachon was enrolled. Personally, I, too wonder that.
As you know, in general I support the FDA. Indeed, I have on occasion written paeans to FDA heros like Frances Kelsey, who prevented the approval of thalidomide in the early 1960s. I have explained how “right to try” laws are cruel shams of placebo legislation that promise cures to terminally ill patients but deliver, in essence, nothing and are in fact an long game to gut the authority of the FDA in the name of a libertarian ideology. Indeed, given that Texas recently passed its own “right to try” legislation, I’m rather surprised that Burzynski didn’t just administer ANPs to Fachon in Houston under Texas’ new law. There was nothing to stop him. On the other hand, perhaps Burzynski was concerned that his clinical trial being under a clinical hold might have invalidated right-to-try in this case, particularly if he were to do it while his trial in front of the Texas Medical Board was still in progress.
Unfortunately, as much as I’ve defended the FDA, I can’t defend its utter failure to protect the public from Stanislaw Burzynski. It’s failed time and time and time again, and it failed yet again in this instance. It’s handling of the Stanislaw Burzynski case has been a travesty. I could (sort of) understand why the FDA backed down in the 1990s. Back then, Burzynski had powerful allies in Congress, such as Rep. Joe Barton (R-Texas), who used his powerful committee chair to torture then FDA Director David Kessler over the FDA’s treatment of Burzynski, complete with the aforementioned political theater of Burzynski patients pleading for their lives; more specifically, pleading for the FDA to let Burzynski continue.
Unfortunately, Neil Fachon’s family is cut from the same cloth. Wendy Fachon, for instance, works for a magazine called Natural Awakenings Rhode Island. I’m familiar with Natural Awakenings. We have our own version called Natural Awakenings Detroit. Basically, it’s a quack magazine. No wonder Neil Fachon was so open to the claims of Stanislaw Burzynski. His mother works for a magazine that basically exists to advertise quackery.
Overall, despite being factually accurate, the STAT News story gives a profoundly misleading impression, namely that there might be benefit due to ANPs and that Burzynski, despite his checkered past, should be allowed to continue. If you don’t believe me, look at the conclusion of Tedeschi and Kaplan’s article, which provides the impression that the authors clearly want to leave you with
“Especially for kids going through this kind of thing — myself included — it’s something we need to be reminded of, because the whole situation can become so oppressive at times,” he said. “So to have that message of positivity and laughter and love for life … that’s the message I’m trying to bring to people.”
Meanwhile, Wendy Fachon said she is considering supporting legislative initiatives that might help patients in similar situations gain more control over their medical treatment. She has already heard of at least one other child who was blocked by the FDA from joining her son on Burzynski’s trial.
“My heart goes out to those families, because I know what it’s like,” she said.
As for Neil’s future, she said: “We are very optimistic for his recovery. His story can’t end now. I think his story is just beginning.”
“I’m feeling pretty good,” he said. “I don’t plan to stop feeling pretty good any time soon.”
Unfortunately, this is almost certainly not true. I realize that it’s not at all unlikely that the family might see this piece, and it gives me no pleasure that they might. No doubt Burzynski supporters will label me insensitive for being blunt, but it needs to be said, because pretending that Burzynski’s ANPs might be giving Fachon a fighting chance, as Tedeschi and Kaplan have done whether they realize it or not, does neither Fachon nor his family any favors. Worse, publishing an article like this potentially does other cancer patients damage by planting the idea that Burzynski might be on to something in their minds. Indeed, the spate of stories about UK patients with brain cancer raising money to come to Houston were the best advertising that Burzynski’s money couldn’t buy. This article is cut from the same cloth.
I stand for cancer patients, and part of that stand is to provide accurate information in as empathetic a manner as I can. Unfortunately, from my perspective, cancer patients are being deceived by Burzynski advocates who cloak Burzynski’s profoundly unethical activities in the mantle of “right to try.” Neil Fachon is a victim. He’s been dealt a horrible hand. Burzynski isn’t going to make it any better. Rather, he’s using Neil Fachon, and unfortunate patients like him, as advertising fodder, in essence victimizing him a second time, after the DIPG made him a victim the first time. Burzynski is also using such patients as weapons in his battle with the government, just as he did in the 1990s. Basically, in structure, this story is no different than the many stories I saw a decade ago that featured for antivaccine parents who blamed their child’s autism on vaccines and, based on that belief, subjected them to all manner of quack treatments based on that belief. Sure, the denials of scientists were included, but the overall impression left was of brave parents bucking the system and doing anything the thought necessary to cure their children.
In the end, especially given the way that Tedeschi and Kaplan chose to conclude their article, the overall impression left by it is that the FDA was wrong to shut down Burzynski’s clinical trial, that Fachon should be allowed the “right to try” Burzynski’s disproven—that’s right, not unproven, disproven—treatment, and that his struggle could benefit other cancer patients by forcing the FDA to let patients have more access to experimental therapies. It will not, at least not if it prolongs the farce that is the Burzynski Clinic. In fact, it would be a great thing for patients with DIPG if the Burzynski Clinic were to shut down today. Stanislaw Burzynski has had 40 years to prove that his ANPs have anticancer activity. Even given opportunity after opportunity, he’s utterly failed. Tedeschi and Kaplan should realize that, but they didn’t. After all, that wouldn’t be a very uplifting message. It might, however, save others from making the same mistake that so many others have.