This is an SBM public service announcement—with blogging! Think of it as a bonus post, and don’t forget to read Mark Crislip’s regular biweekly offering, as it’s about an article in Skeptical Inquirer that particularly irritated him—and me, as well. Because, as we all know, the world needs more Mark Crislip.
I’ve made no secret of how much I despise Stanislaw Burzynski, the self-proclaimed cancer doctor and medical researcher who has been treating patients with an unproven, unapproved chemotherapeutic agent since 1977, seemingly slithering around, under, over, and past all attempts to investigate him and shut him down. Indeed, just type his name in the search box of this blog, and you will see copious evidence of my disdain for the man. Over 37 years, Burzynski has become a hero to the cancer quackery industry, touted as the man who can cure incurable cancers that science-based medicine can’t, even though his treatment, antineoplastons, allegedly peptides isolated from blood and urine that normally keep cancer in check in healthy people, are by any reasonable definition chemotherapy. Indeed, they are toxic, with a number of side effects reported, the most common and dangerous of which being life-threatening hypernatremia (elevated sodium levels in the blood). All you have to do is to type Burzynski’s name into the search box of this blog, and you’ll find copious documentation of the abuses of patients, science, and clinical trials perpetrated by Stanislaw Burzynski and the cult of personality that has evolved around him. He’s even acquired his very own film propagandist, a credulous fellow named Eric Merola, who has made two astoundingly bad documentaries that are nothing more than unabashed hagiographies of the brave maverick doctor curing cancer where no one else can. They’re chock full of misinformation, pseudoscience, spin, and obvious emotional manipulation, and the first one at least, was very popular.
For the longest time, I’ve been hoping that major mainstream news organizations would take this story on. It’s happened from time to time, but until 2013 it hadn’t happened in a long time. Earlier this year, the BBC featured Burzynski in an episode of its long-running series Panorama. It was a mixed bag that took the fairly easy path of making it all about the patients and never really delved into what I believe to be the central mystery of the four-decade-long Stanislaw Burzynski story, and that’s how he’s managed to keep his medical license and register clinical trials right up until 2012. That was a disappointment, although much of the rest of the Panorama episode was very good. He still has his medical license, but as I’ve pointed out several times, the FDA placed a partial clinical hold on Burzynski’s antineoplaston phase II clinical trials back in the summer of 2012. A partial clinical hold means that no new patients could be enrolled, but patients already on them could continue to receive treatment. In 2012, apparently a child died on antineoplastons, and so a partial clinical hold was placed on the trials involving children. That clinical hold was extended to adults in January 2012, with much wailing and gnashing of teeth among Burzynski apologists, as the FDA investigated between January and March. We now know the results of that investigation, but we never knew much about how that partial clinical hold came about.
Now, thanks to Liz Szabo at USA Toda, we know from her article “Doctor accused of selling false hope to families“:
On the last day of his life, Josia Cotto’s parents gave him a choice.
The 6-year-old boy had been fighting an inoperable brain tumor for 10 months. When his mother, Niasia Cotto, found him in his bed, unresponsive and unable to open his eyes, “we knew there was nothing else that we could do,” she said.
An ambulance took Josia to a hospice room at a local hospital. His parents covered him in a soft, blue-and-white blanket, hugged him and held his small hand for the last time.
“We told him the choice was his, whether to keep fighting or be in peace with God,” said his mother. “He chose.”
Josia’s parents would have paid any price to save him.
A Texas doctor, two months, earlier, had given them one: $25,000 upfront, by cash or check.
It turns out that Josia Cotto was the child who died of complications from Burzynski’s treatment:
The FDA’s patience with Burzynski apparently wore out after Josia died.
In a report sent to the FDA after the boy’s death, Burzynski’s staff acknowledged that his last blood sample, taken the day he passed away, showed a blood sodium level of 205 millimoles per liter, a level that is typically fatal. Burzynski’s staff blamed that reading on a “false laboratory report based on a contaminated sample.”
Yet hypernatremia is one of antineoplastons’ most common side effects, known to doctors for two decades.
One of Burzynski’s own informed consent documents — the form that patients sign before they begin treatment — put the risk at 21%.
On July 30, 2012 — six weeks after Josia’s death — the FDA forbade Burzynski from giving antineoplastons to any new children.
I was astounded to see that number. I’ve never, ever seen a sodium level that high. Typically, normal is between 135 and 145 mEq/L, with slight variations of that range depending on the lab. Burzynski’s excuse, which I’ve heard at various times as being due to an “improper blood draw” or as described above, contamination, is purest nonsense. A bad blood draw typically produces falsely elevated potassium levels, not sodium levels. Unless the technician spiked Josia’s sample with 3% saline or something like that, there’s no way to get the level that high. Josia almost certainly died because of hypernatremia from antineoplaston therapy.
To me, this is the biggest revelation: The story and identity of the child who was killed by Burzynski’s treatments. We also learn that—surprise surprise!—Stanislaw Burzynski is an enormous tool. Look at him dismiss his critics, particularly former patients, many of whom, let’s recall, have terminal cancer, many of whom are dead:
Burzynski dismisses criticism of his work, referring to his detractors as “hooligans” and “hired assassins.”
As for criticism from former patients, Burzynski says, “We see patients from various walks of life. We see great people. We see crooks. We have prostitutes. We have thieves. We have mafia bosses. We have Secret Service agents. Many people are coming to us, OK? Not all of them are the greatest people in the world. And many of them would like to get money from us. They pretend they got sick and they would like to extort money from us.”
History will vindicate him, Burzynski says, just as it has vindicated other persecuted medical “pioneers,” such as Louis Pasteur. In the future, Burzynski says, everyone will use his therapies, and the cancer treatments used today — such as surgery, chemotherapy and radiation — will be regarded as barbaric. “There will be a time when people will see the light,” he says, “and our treatments will be used by everyone.”
You know, whenever I hear Burzynski fans like Eric Merola accuse skeptics of attacking cancer patients, accusing them of horrible things, I think I will throw this quote right back in their faces. Here’s Burzynski calling his patients prostitutes, thieves, and mafia bosses, and “not the greatest people in the world,” while accusing them of wanting to “extort money from us.” He also liberally uses the Galileo gambit, but that’s not surprising, as he’s repeatedly made the hilariously arrogant and scientifically ignorant claim that he is a pioneer in genomic and personalized cancer therapy and that M.D. Anderson Cancer Center and other world-class cancer centers are “following his lead.” Indeed, he claimed to have invented the field 20 years ago. Sadly, his publication record does not support such grandiose assertions.
There’s a lot more in this story, some of it contained in the sidebars “Experts dismiss doctor’s cancer claims” and “Families run out of hope, money after cancer treatments. Other than some of the revelations that I didn’t really know much about before, much of what is contained in the rest of this story will be familiar to regular readers here. For instance, experts are saying the same things I’ve been saying for a couple of years now about Burzynski’s anecdotes of “miracle cures,” such as Hannah Bradley and Laura Hymas. The reasons for these anecdotes include:
- Burzynski often relies on anecdotes, which don’t tell the full story.
- Burzynski’s therapies are unproven.
- Burzynski’s patients may have been misdiagnosed.
- Burzynski’s patients may have been cured by previous therapy.
There’s a reason why I’ve spent so much time deconstructing Burzynski anecdotes, and it’s for all of those reasons plus that anecdotes are often interpreted incorrectly by patients without medical training. Even doctors who are not oncologists sometimes interpret such anecdotes incorrectly to indicate that the cancer therapy chosen is the therapy that cured the patient. It’s not just Burzynski patient anecdotes, but it’s any cancer cure anecdote. That’s why clinical trials are necessary to differentiate all these confounding effects from actual effects due to the treatment. Indeed, the patients featured in Ms. Szabo’s article have nearly all been discussed by me before, including Mary Jo Siegel, who had a fairly indolent cancer for which the standard of care has changed from very aggressive treatment up to and including a bone marrow transplant to less aggressive therapy that acknowledges that these are slow-growing tumors. Worse, her story is lost in the mists of time, where what now exists are only highly selected medical records posted on various websites.
Indeed, Ms. Szabo even explains one aspect of the concept of pseudoprogression in a simpler way than a certain “friend” of mine did, lo, those many moons ago:
Many of Burzynski’s patients are terminally ill and have had one or more previous types of conventional cancer care — surgery, radiation or chemotherapy — before they see him.
But these therapies may have delayed benefits, taking weeks or months to shrink a tumor. So patients treated by Burzynski may credit him for their progress, just because he was the last doctor to treat them, says Peter Adamson, chair of the Children’s Oncology Group, an NCI-supported research network that conducts clinical trials in pediatric cancer.
Conventional cancer treatment can also cause tumors to swell temporarily, due to inflammation. A patient who isn’t familiar with this phenomenon may assume her tumor is growing. When that swelling subsides, patients may assume it’s because of Burzynski, Adamson says. In reality, the tumor was just returning to its previous size.
To avoid such confusions, researchers typically require patients to wait before starting a new treatment, Adamson says.
FDA inspections, obtained through the Freedom of Information Act, show that Burzynski has repeatedly failed to follow that basic practice.
Pseudoprogression can be a real confounder in assessing the response of brain tumors to therapy, being observed up to 28% of the time. It’s most common after surgery and radiation therapy, although it can happen after chemotherapy too. Not coincidentally, Hannah Bradley had surgery, chemotherapy, and radiation, and Laura Hymas had radiation and chemotherapy. These are the sorts of pitfalls that real cancer doctors doing real clinical trials already know about and work to minimize. Burzynski, in his arrogance, never thought he needed to bother with the sort of expertise that could validate his therapy. None of this stops Burzynski patients from being lured into spending hundreds of thousands of dollars on Burzynski’s treatments.
It’s very heartening to see a story like this in a major news outlet, and I must congratulate Ms. Szabo for her thorough deconstruction of the phenomenon that is Stanislaw Burzynski. True, a bit of false balance did sneak in here and there. For instance, the Siegels are featured, as are other Burzynski patients who believe he cured them when he almost certainly did not, in a video accompanying the story, and the title of the series is a rather clichéd “Science or Snake Oil.” However, the false balance that is so ingrained in the culture of journalism seems to be noticeably less apparent in this article than on many other stories about Burzynski that I’ve read. That’s good.
Before I close, I can’t help but mention that the most disappointing thing about this news story was that it still hasn’t revealed what I consider to be the two central mysteries of the Burzynski saga: First, how is it that Stanislaw Burzynski can still practice medicine? I know it’s Texas, but this has been going on for nearly 37 years. Second, why has he been allowed to continue to do clinical trials up until a little more than a year ago, and why is it that, even now, the FDA hasn’t shut him down permanently? Ms. Szabo sheds a little light on that, but nothing that regular readers of this blog don’t already know about the political machinations in the 1990s that led to Burzynski’s six dozen phase II clinical trials. Apparently, even Ms. Szabo and USA Today couldn’t crack that nut. Maybe public pressure can. The concluding section of the story tells us why we need to try:
No one told Josia’s parents about any of this.
Not Burzynski. Not the FDA.
Jose and Niasia Cotto had no idea that their son’s death prompted an investigation by the FDA, until they were contacted by USA TODAY.
The Cottos had long believed that Burzynski could have cured their son if only they had taken Josia to see him first, before giving him radiation and chemotherapy. They had even hoped to launch a non-profit, A Life for Josia Foundation, to help other children with cancer gain access to Burzynski’s treatment.
Now, they don’t know what to think.
Remember how I said that Bob Blaskiewicz will want your help? Now’s the time to contact him, if you haven’t already.