Stanislaw Burzynski: Slapped down by the FDA once again

I sometimes think that Stanislaw Burzynski is a lot like the Bloody Mary of folklore, or perhaps Candyman of the famous horror movie—or perhaps like a number of other legends and horror stories—in that all it seems to take for him to show up in the blogosphere again is for me to recite his hame enough times. Yes, I know that it’s a bit of confirmation bias on my part and whether or not some new Burzynski news happens to come to the fore again has little or nothing to do with my invocation of his name, but it is a rather amusing thought. Be that as it may, it was just late last week that I pointed out that another one of Burzynski’s patients had died tragically. This week, I find out from several of my readers that a new warning letter from the Food and Drug Administration to the Burzynski Clinic dated October 18 had been posted to the FDA website. Basically, the FDA is calling out Dr. Burzynski for his promotion of antineoplaston therapy because his antineoplastons are considered investigational and it is illegal to advertise and promote investigational agents as being effective.

As the FDA warning letter states:

Antineoplastons are investigational new drugs that do not have marketing authorization in the United States. An investigational new drug (IND) application was submitted to the FDA in [REDACTED].

Promotion of an investigational new drug is prohibited under FDA regulations at 21 CFR 312.7(a), which states, “A sponsor or investigator, or any person acting on behalf of a 1 sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.”

The websites, including the posted press releases and embedded videos, contain claims such as the following that promote Antineoplastons as safe and/or effective for the purposes for which they are being investigated or otherwise promote the drugs.

The FDA letter then lists a number of examples from the Burzynski Clinic website, including glowing statements about how well antineoplastons allegedly work, press releases that are in essence nothing more that testimonials of miracle cures and amazing responses in patients, plus a number of promotional appearances by Dr. Burzynski himself in which he touts antineoplastons as being, in essence, the greatest breakthrough in cancer therapy ever. I’m amused to note that one of the clips mentioned by the FDA in its complaint was an interview that Burzynski did for KHOU in Houston appear no longer to be on YouTube, at least as far as I’ve been able to find. Two of the videos, which I have watched before, are now private, and I can’t find the other part. However, the same video appears to be present on the KHOU website in two parts. The FDA points out that it is illegal to make these sorts of claims for a drug that has not yet been FDA-approved for a given indication:

As stated above, some of the above-referenced claims suggest that the drugs are “well tolerated,” “work without causing side effects,” and have demonstrated “remarkable” results. The totality of these claims suggest that Antineoplastons, investigational new drugs, are safe and/or effective for the treatment of the various types of brain tumors indicated above, when they have not been approved for these uses.

Since Antineoplastons are investigational new drugs, the products’ indication(s), warnings, precautions, adverse reactions, and dosage and administration have not been established and are unknown at this time. Promoting Antineoplastons as safe and effective for the purposes for which they are under investigation, by making representations such as those noted above, is in violation of 21 CFR 312.7(a).

I’ve discussed Burzynski on numerous occasions, and I think the FDA is actually being too easy on him. As I’ve pointed out as recently as last week, a credulously clueless filmmaker named Eric Merola made a “documentary” that was, in effect, a 90 minute commercial for the Burzynski Clinic and Stanislaw Burzynski that only contributed to his cult of personality, all with the obvious complete cooperation of Stanislaw Burzynski and his clinic. In addition, Burzynski advertises antineoplastons as part of his “personalized gene targeted cancer therapy,” which I tend to refer to as “making it up as you go along.” It’s rather odd, of course (well, no, it isn’t, actually), that somehow every single one of the “personalized gene targeted cancer therapy” regimens that Burzynski ever comes up with always seem s to include antineoplastons (or, sodium phenylbutyrate, which is the same thing as one of the antineoplastons that Burzynski sells). Regardless of what Burzynski calls them, however, he promotes antineoplastons with glowing terms.

Being a translational-clinical investigator myself struggling to try to identify molecular targets in breast cancer and develop strategies to exploit them to treat breast cancer, what makes my blood boil, what makes puts my anger on a low seething boil that periodically bubbles over, is just how blatantly Burzynski flouts medical ethics, just how bad his science is, and how he exploits his patients by promising them what are in essence “miracle cures” and then charging them tens to hundreds of thousands of dollars in order to take part in his “clinical trials.” Sure, he makes lots of excuses for why he does this. He’ll tell anyone who’ll listen that he runs a small research institute, that he doesn’t have the money, but, a far as I can tell, it’s all a sham. Burzynski represents himself as someone who came to America from Poland back in the 1960s “with twenty dollars in his pocket, a theory in his head, and an indefatigable attitude that shown in his smile.” These days, he’s incredibly rich.

If Burzynski really believed in his therapy the way he says he does, he could manage to do clinical trials the way they’re supposed to be done, with no expenses related to the experimental treatment paid for by the patient enrolling in the trial. Sure, he might not be able to do more than a few clinical trials, but he could do carefully targeted trials that might actually tell us whether antineoplastons have anticancer activity, rather than his laundry list of phase II trials, only a few of which accrue very many patients and even fewer of which he ever publishes on. That’s the way big pharma has to do it; it’s the way that medical academia has to do it; somehow, Burzynski doesn’t think he should have to do it that way. Instead, he thinks it’s perfectly fine to force his patients to pony up their life savings and more, to the point where many of them feel as though they have to start holding fundraisers in order to pay Burzynski’s exorbitant charges for what they view as their last chance to live.

Indeed, it’s even been alleged that Burzynski will go so far as to persuade patients to refuse chemotherapy, stem cell rescue, and other conventional therapy in favor of antineoplastons. The Twenty-First Floor has noticed that a video was posted to YouTube by a disgruntled Burzynski patient accusing him of just that. Unfortunately, that video is now private (just like the KHOU videos that Burzynski used to have on his website). Whether these allegations are true or not, I don’t know, although they go so far as to accuse him of falsifying medical records, but they are of a piece with FDA’s previous criticism of how Burzynski has played fast and loose with ethical approval of his clinical trials by institutional review boards.

I like to think that the noose is slowly tightening around Burzynski, between the FDA warning letters and his ongoing problems with the Texas Medical Board, but I can’t. Although it is hard for me to imagine someone more deserving of being shut down and completely shunned from any and all medicine, over the last 30 years Burzynski has had amazing staying power and an ability to dodge the law and to represent himself as a Brave Maverick Doctor whose antineoplastons are a far better treatment than chemotherapy and radiation to gullible alternative medicine mavens, despite a record that, when looked at objectively, is quite dismal. I keep hoping I’m wrong, but I can’t help but fear that once again he’ll manage to slither his way out of his current difficulties. I truly hope I’m wrong.