No more antineoplastons? Will the FDA finally slap down Stanislaw Burzynski for good?

Earlier this week, there was a very bad, very credulous story was broadcast. Now, I realize that this is not an uncommon occurrence. Indeed, I’m sure that this sort of thing happens pretty much every day somewhere in the country and even on national media, but on this particular occasion the story was about a man who has become a frequent topic of this blog, namely Stanislaw Burzynski. Burzynski, as you recall, is the Polish physician who runs a cancer clinic in Houston that attracts desperate patients with advanced cancer from all over the world to spend huge sums of money for his treatment, which consist of chemicals he calls “antineoplastons.” What attracts these patients to travel thousands of miles and pay tens or hundreds of thousands of dollars? It’s the promise, promoted by the Burzynski Clinic and the various shills and minions who are true believers in Burzynski’s “alternative cancer therapy,” of life when conventional medicine cannot save them. Burzynski claims to have discovered endogenous anti-cancer compounds in human urine (his “antineoplastons”), and now he synthesizes them and administers them to patients. Unfortunately, there is no convincing evidence (or even much evidence at all) that antineoplastons have significant cancer activities or that they work better than conventional therapy, even against advanced cancers. Lately, he’s been coupling his antineoplastons with something he calls “personalized gene-targeted cancer therapy,” or, as I like to call it, “personalized cancer therapy for dummies.”

Unfortunately there are a lot of reporters out there who don’t get the message, particularly a credulous reporter from Fox 8 News in New Orleans named Rob Masson, who earlier this week did a story about a patient of Stanislaw Burzynski’s and in the process fell for just about every trope arising from Burzynski’s cult of personality and pretty much every bit of self-aggrandizing nonsense that Burzynski routinely lays down, to the point where I was thinking that it would be dangerous to play a drinking game where everyone had to drink every time a Burzynski talking point showed up, and the story is only around six minutes long! By the time Masson opines at the end how “after thirty years of doing this therapy,” Burzynski is “finally going to the FDA” the you’d be in serious danger of ethanol poisoning. Of course, it never occurs to Masson that perhaps the reason it’s been over 30 years is because there’s almost certainly no “there” there when it comes to antineoplastons, which is probably why Burzynski is moving on to what I call his “personalized cancer therapy for dummies” and his “rebranding” of antineoplastons as an “antiaging treatment” called Aminocare® genetic solutions.

It’s interesting to compare and contrast how the media reports on Burzynski with what’s actually going on over at the Burzynski Clinic, because just yesterday morning I became aware of a disturbance in the skeptical blogosphere, a notice, if you will. More about what I’m talking about in a moment, but first let’s look at the story Controversial Cure: Doctor defends cancer treatment. You can tell right away from the very title of the story that it’s going to be a puff piece “human interest story, and so it was:

It starts out with a woman, who declined to be identified, telling her story. Basically, she was diagnosed with breast cancer but decided to eschew mastectomy and conventional cancer therapy in favor of all manner of woo, which she thought worked for years. Given that the various dubious therapies this woman pursued have, as far as I can tell, no evidence of efficacy against breast cancer, in essence this woman remained untreated until:

And the cancer worsened. She developed tumors and by May 2008 she had fluid in her lungs — Mary finally sought a doctor’s treatment.

She became unconscious and was brought back to life with a massive blood transfusion. She then took estrogen blockers and her symptoms improved. But two years later, the cancer came back, this time in her back. Herbal remedies and pills were no longer an option.

Mary got 16 radiation treatments and, like many cancer patients, she followed that up with chemotherapy. But then heart problems caused doctors to stop the treatment.

Mary’s body could no longer tolerate traditional cancer therapies such as radiation and chemotherapy. So she went to Houston to see Dr. Stanislaw Burzynski.

One thing I can tell from even this little bit of information is that the woman had an estrogen receptor (ER)-positive tumor, which might explain why she lived so long untreated. A subset of ER(+) tumors can be pretty indolent and take a long time to grow and spread, even after they’ve reached stage IV. More than likely, that’s the sort of breast cancer this woman had. Not knowing more about her original presentation, I can’t say for sure, but knowing her ultimate clinical course, I’m pretty sure that more than likely her cancer would have been curable if she had simply undergone the appropriate treatment when she was originally diagnosed. In any case, we have the story set up in a typical Burzynski hagiography: The patient is portrayed as at the end of the line, and only Dr. Burzynski can save her. He can’t, of course, but he’s very convincing, except, that is, to people who have a working understanding of cancer biology and molecular biology. To us, his blather about “turning molecular switches on and off” or how he was the first person to propose gene-targeted therapy are obviously nothing more than the arrogance of ignorance that nonetheless leads to failures of medical journalism. That’s not to say that the story is all bad; there is the token skeptic in the form of a local oncologist named Dr. Jane Gertle, who quite correctly points out that, compared to Burzynski, who has his patients pay for his “clinical trials,” pharmaceutical companies “put their money where their mouth is.”

Sadly, the patient, who is referred to as only “Mary,” died last week. Unfortunately, that didn’t stop this report from saying that although she never “completely kicked her cancer,” “she was showing progress.” If Mary’s outcome represented “showing progress,” I’d hate to see what would represent deterioration to this clueless reporter.

This reporter’s credulity aside, this is where Burzynski makes two revelations. First, he says:

We never charged patients in clinical trials.

My jaw dropped when he said this, and I don’t think Burzynski helped himself at all with this. Think about it. If he truly never charged patients to be on his clinical trials, then that means that he must be charging patients for an unproven drug not approved by the FDA, which he routinely ships across state lines as reported by multiple patients, in direct violation of the consent agreement with the Texas attorney general in the 1990s stating that Burzynski: “(a) cannot distribute unapproved drugs in Texas; (b) can distribute ‘antineoplastons’ only to patients enrolled in FDA approved clinical trials, unless the FDA approves his drugs for sale; (c) cannot advertise ‘antineoplastons’ for the treatment of cancer; and (d) on his website and in promotional material and ads must place a disclaimer that the safety and effectiveness of ‘antineoplastons’ have not been established.” If, on the other hand, the Burzynski Clinic actually has charged patients to be on clinical trials, as so many patients have reported, then Burzynski would appear not to have told the truth to the reporter. Either way, it’s not good, and I can’t figure out why he would say such a thing, and I’m not alone in wondering at the red flag Burzynski’s statement raises.

The next revelation was:

Phase two testing of Dr. Burzynski’s treatments are now wrapping up, both in Houston and overseas in China and Japan. He says he is eager to get through the next phase.

This statement raises even more eyebrows. First of all, as I and others have discussed time and time again, Burzynski has registered over 60 clinical trials at ClinicalTrials.gov over the last 20 years or so, but has reported none of them. Burzynski has been “wrapping up” his phase II trials at for at least 15 years now and appears no closer to publishing a convincing phase II trial than he’s ever been. I call BS. As for these clinical trials in China or Japan, I haven’t been able to find any evidence of them, other than references to the Japanese National Cancer Institute reporting that antineoplastons did not work in their studies and vague references from believers to research being done in Japan. None of it’s been published, as far as I can tell, at least nothing recent that contradicts existing studies that have failed to find a benefit from antineoplastons.

It is particularly amazing that Burzynski would make such claims in light of recent events. Not long ago, bloggers noticed that Burzynski had scrubbed antineoplastons from the Burzynski Clinic website in a recent update. At the time I characterized the observation as “rather interesting,” and thought that maybe it was due to a recent warning letter sent to the Burzynski Clinic by the FDA telling it to cease and desist advertising antineoplastons because doing so is promoting an unproven drug. Given how fast and loose Burzynski has appeared to play with human subjects protection regulations over the years, one wondered if something more was going on.

Maybe there was, which brings us back what might really be going on at the Burzynski Clinic. Yesterday morning, I awoke to multiple Twitter notices and e-mails pointing out that one of our British skeptical friends, Keir Liddle, had posted some news over at Josephine Jones’ blog while, five hours behind the UK, I slept. Then I had to go to work and couldn’t revisit the topic until last night. What I learned is that the parents of a patient at the Burzynski Clinic had posted on their Caring Bridge blog that the Burzynski Clinic is currently undergoing an audit by the FDA and that the Burzynski Clinic is, for now, shut down when it comes to administering antineoplastons. Like Keir, I won’t reveal the name of the patient, but I will quote a bit more than he did from the blog:

The Burzynski Clinic is going through some issues right now. They are in the process of getting audited for the past month by the FDA. The FDA has also gotten approved to continue their audit for another month. I believe it was August, the FDA stopped new pediatric patients because a child had went into a tumor related coma and did not get enough water during treatment, thus spiking the sodium level to a fatal level. Now, in January, for reasons unknown to me, the FDA has suspended new adult patients from the ANP as well. I do not know when the new patients will be allowed again or if any restrictions on current patients will also follow. Friday, the Burzynski Clinic shipped us 3 months of ANP, where they normally only ship 2 weeks. They are being proactive and making sure we have the meds she needs just in case any medicine production is stopped. Apparently, a person who monitors the medicine production had a serious medical emergency. This, along with the FDA auditing has us a little on edge waiting to see how it all plays out. Even though this is bad news for the clinic, there is silver lining because when this is finished, the clinic should be moving into Phase 3 of the clinical trail and hospitals and doctors should be able to start prescribing the ANP and doing clinical trials of their own. To my knowledge, Dr. Burzynski has the only medicine not sponsored or picked up by a pharma company. I think that’s why things don’t work like they do for normal drug approval.

So much for Burzynski’s frequent claim that antineoplastons are nontoxic. Dangerous levels of hypernatremia (high sodium) are a known and expected complication of administering a drug as its sodium salt in such enormous quantities, and I do mean enormous quantities. Indeed, the dose of sodium that can be administered from the high dose antineoplaston protocol can be as high as 148 g per day from the high dose antineoplaston formulation, which for an 88 kg patient would require that 12 L of free water be administered in order to prevent massive hypernatremia. If this patient’s family’s account is true, it would appear that a child died of hypernatremia while under Burzynski’s care, and that finally got the attention of the FDA. I have no idea if what this patient’s family is saying is accurate or not, but they don’t have any reason to lie. Moreover, if this really is what Burzynski is telling his patients (and it sounds as though it is), we should find more patients telling the same tale soon enough.

What would be even better would be if we soon hear of the FDA bringing an enforcement action to stop Burzynski from treating anyone else with antineoplastons and investigate—I mean really investigate—what Burzynski was really doing all those years when he claimed to be signing up patients to phase II clinical trials while the Burzynski Clinic charged tens and hundreds of thousands of dollars for antineoplaston therapy, much of which had to be paid out-of-pocket because insurance companies and government health plans quite reasonably won’t pay for unproven therapies. Sadly, I fear that, should the FDA finally shut Burzynski’s antineoplaston operation down, it won’t stop him. It wouldn’t surprise me at all if he packed up his clinic (or part of his clinic) and moved it to, say, Tijuana or Costa Rica or someplace else where patient protections are—shall we say?—not quite as rigorous as they are in most industrialized countries. There, Burzynski’s clinic could function along with all the other alternative cancer clinics. Indeed, his Houston operation could even become a “feeder” for his out-of-country operation, applying his “personalized gene-targeted therapy for dummies” approach. Or he could even dump antineoplastons altogether, pivoting to switch completely over to some combination of his “personalized gene-targeted therapy” and/or sodium phenylbutyrate.

No, as optimistic as I’ve become that maybe—just maybe—the FDA has finally gotten serious about Stanislaw Burzynski and the Burzynski Clinic, I’m under no illusion that even if the FDA shut him down it would mean the end of Burzynski’s “alternative” cancer treatments.

But it would be an excellent first step.