Stanislaw Burzynski in NEWSWEEK: How long can his “unprecedented medical malfeasance” continue?

I didn’t think I’d be writing about Stanislaw Burzynski again so soon, but to my surprise a very good article in Newsweek describing cancer quack Stanislaw Burzynski popped up in my Google Alerts yesterday. I hadn’t expected much in the way of news coverage about Burzynski for several months, given that the second half of Burzynski’s trial before the Texas Medical Board had been delayed by his having suffered a heart attack and isn’t expected to begin again for several months. Entitled Cancer “visionary” Stanislaw Burzynski stands trial for unprecedented medical malfeasance and by Tamar Wilner, it’s the sort of article I like to see in the mainstream media but, unfortunately, fail to see often enough. Instead, unfortunately, far more common are articles and films using sympathetic cancer patients to try to defend Burzynski. I say I was “surprised” by it because, although I do remember being in contact with Wilner in November, I had more or less forgotten about our exchange and had no idea when or if the article would be published. I have, after all, learned over the years that just because a journalist contacts you about an article doesn’t necessarily mean that the article will ever see print.

The Newsweek article begins with the story of a patient. It’s one who I haven’t blogged about before, surprisingly:

When Sandra Cohen was diagnosed with breast cancer, she did whatever she could to avoid chemotherapy. She took homeopathic remedies and herbs, and she changed her diet. She even tried laser therapy. Nothing worked. When she reached stage IV—the cancer metastasized to her lungs, clavicle bone and lymph nodes—her doctors were shocked. “The doctors here just kind of shook their heads and said, ‘How did you let this go so far?’” she recalls.

But she didn’t give up. Instead, she went to Stanislaw Burzynski.

It turns out that Cohen is like a lot of Burzynski patients about whom I’ve blogged. She appears to have been helped by conventional medicine but credits Burzynski, although it’s not clear to me whether she is joking or not, as the passage is somewhat ambiguous:

Sandra Cohen is a Burzynski success story—sort of. She went to him seeking antineoplastons, and when she didn’t qualify, she reluctantly started on chemotherapy and later agreed to surgery. Five years later, she is cancer-free. “Dr. Burzynski saved my life,” Cohen says.

I wish there had been a bit more detail given, as it’s very difficult for me to analyze this case the way I’ve analyzed other Burzynski patients. More important is the description to a wide audience of Burzynski’s malfeasance. Kudos to the editor who chose the term “unprecedented medical malfeasance” to describe Burzynski’s activities over the last four decades. If there is a precedence to what Burzynski has done, I am unaware of it. Certainly, I’m unaware of anyone who’s practiced this way as long as Burzynski has and gotten away with charging patients such outrageous fees to administer an unproven cancer medication. As I’ve discussed more times than I can remember, he’s been doing this at least since around 1977, possibly earlier.

Let’s recap the TMB charges:

In a 48-page complaint, the Texas Medical Board says Burzynski and his staff knowingly misled patients, attracting them to the clinic with the promise of being included in trials for antineoplastons, when they knew most of the patients wouldn’t qualify. The doctor or his staff told patients they would get the antineoplastons, before charging large retainers and ordering other treatments. The Burzynski clinic admits that about 5,700 of its 8,000 patients have received treatment other than antineoplastons.

Yes, this is the “bait and switch” Burzynski does. When he can’t give antineoplastons because a patient doesn’t meet the inclusion criteria for one of his trials, Burzynski offers him his incompetent version of “personalized gene-targeted cancer therapy” for dummies often containing sodium phenylbutyrate, all the while bragging risibly about being a “pioneer” in the field of genomic medicine.

I also like how Wilner grasps the essence of Burzynski’s “make it up as you go along” claims for his “personalized gene-targeted therapy”:

On its website, the Burzynski Clinic says it offers “personalized cancer therapy,” using genetic analysis to customize treatment for each patient. But in expert testimony for the medical board, Dr. Cynthia Wetmore, director of the Center for Clinical and Translational Research at Emory–Children’s Pediatric Research Center in Atlanta, said, “There’s not a possible way to tell what drug is helping and what drug is not helping. The drugs are given in unstandard [ sic ] combinations that never have been tested. They’re given in unstandard doses that are not known to be effective or safe. And combining them is experimenting on humans, which cannot be done outside a clinical study. That’s unethical. ”

Indeed.

Burzynski’s response sounds reasonable if you don’t know what he’s really doing:

Burzynski takes a different view—he says the drug combinations are evidence of his innovative approach to medicine. In an email to his former lawyer, Richard Jaffe, in January 2015, he wrote, “It takes a single pioneer to abolish dogma and save countless lives. This is our contribution to medical science.” Burzynski argued that it’s unfeasible to restrict practitioners only to tested drug combinations, because with almost 100 cancer drugs, testing every combination of five agents would result in “hundreds of thousands of trials.”

Well, yes, that’s true in a way, but that’s not the only way to do proper clinical trials of new drug combinations based on genomic testing. Has Burzynski ever heard of, for example, the SHIVA trial? Basically, it was a large clinical trial testing conventional therapy for cancer against molecularly targeted therapy based on tumor molecular profiling. Patients with metastatic cancer would be randomized to standard of care or to the sort of approach that Burzynski does. The difference, of course, is that the doctors doing the gene profiling know what they are doing, at least as much as it is possible to know in an area like this, given the uncertainties. They also had very carefully defined protocols about what to choose when certain gene mutations popped up. Guess what? The trial still disappointed. There was no difference between conventional treatment and personalized therapy in progression-free survival. I still believe there’s great promise for “precision medicine” using gene profiling to guide therapy like this, but it’s clear that we haven’t figured out how to do it right yet and that we lack good drugs for a lot of the molecular targets we discover.

Is there any reason to think that Burzynski can do it right when the best minds in genomic medicine have yet to crack this nut? No, there is not. I was particularly heartened to see Andrew Vickers agree. Vickers, you might recall, doesn’t like skeptics very much because of—shall we say?—a bit of insolence aimed at his acupuncture studies. In any case, Wilner recounts what regular readers have heard about since 2011, namely how Burzynski charges huge sums of money as “case management fees” to administer antineoplastons, how he downplays the toxicity of his magic antineoplastons, and how he has misinterpreted imaging studies. She even quotes Burzynski’s lawyer’s famous remark about how Burzynski’s clinical trials were a “joke” designed to let him treat whomever he wanted to treat with antineoplastons.

Wilner also asks a question that we all ask: Why does the FDA let these studies go on? The response is unsatisfying. First, as with most skeptics who’ve tried to ask the FDA the same question, the FDA simply refused to answer, leading to this observation:

Yale University oncology professor Joseph Paul Eder argues that it’s not really the FDA’s job to stop trials just because a drug doesn’t do anything. The system isn’t built that way. “Typically, whoever’s funding [the trial], the institution, NIH, or somebody else, would say, ‘You’re not meeting your goals. We’re going to need to stop the study,’” Eder says. Since Burzynski funds his own trials—at least in part through patient fees— and hasn’t established a partnership with any institution, there’s never been anyone to apply the brakes.

Technically, Eder is correct, but the answer is unsatisfying. Technically, it’s the job of the institutional review board and/or funding source to stop the trial. Of course, as I’ve documented before, Burzynski’s IRB is run by one of his cronies, and there’s no funding source to answer to. It’s a loophole that Burzynski’s been slithering through for 38 years.

However, it’s not entirely true that the FDA has no role. The FDA often has a lot to say about the design of clinical trials to be performed in order to develop evidence to use in support of an application for FDA approval, which is what Burzynski’s trials are intended for, at least if you believe Burzynski and his sycophants. Also, as we have seen, the FDA has shut Burzynski’s clinical trials down many times, seemingly never permanently despite massive violations of federal regulations overseeing clinical trials. Apparently, even the death of a child is not enough for the FDA to shut Burzynski down permanently. After each time the FDA inspects him or issues partial clinical holds, Burzynski issues soothing responses that somehow convince the FDA that, yes, this time Burzynski really, really, really will be good and play by the rules. In this, the FDA reminds me of Charlie Brown, with Burzynski being Lucy, who promises not to pull the football away again but always does.

And so it has been going for nearly 40 years.

Will the TMB finally stop Burzynski this time, afte so many failed attempts before. Will 2016 finally be the year that he’s shut down? It probably won’t be in 2016. With all the delays, it’s highly unlikely that the TMB will be able to issue a decision this year now. I am, however, still hopeful for 2017.

But not too hopeful.