The Burzynski Clinic continues to issue press releases. Still more hilarity ensues.

No matter how much I try, it seems that I can’t escape blogging about Stanislaw Burzynski. Regular readers here are familiar with Dr. Burzynski, the “maverick” cancer doctor (he’s not an oncologist) who claims that peptides he’s isolated from urine and now synthesizes in his lab and manufacturing facility are highly effective anticancer drugs, so much so that he claims much better results with deadly cancers like glioblastoma than conventional medicine can produce.

There are a number of reasons for my continually being sucked back into the Burzynski orbit, like a spaceship wandering too close to a black hole. First of all, a couple of years ago, when I first started to take an interest in his clinic, his “antineoplaston” cancer treatment, and his “personalized gene-targeted cancer therapy,” I feel as though I served a real public service. The reason is that all the skeptical literature on Burzynski and his dubious cancer cures was way out of date, at least from a scientific standpoint. For instance, although much of what was written about antineoplastons still applied, no one was emphasizing that Burzynski was using an already FDA-approved drug, phenylbutyrate, as a prodrug to generate antineoplastons. More importantly, Burzynski had branched out. He wasn’t using just antineoplastons anymore. Unfortunately, somewhere along the line Burzynski discovered genomics and dove in with reckless abandon (not to mention a heapin’ helpin’ of the arrogance of ignorance) to create what I like to call personalized gene-targeted cancer therapy for dummies.

Fortunately for cancer patients, 2013 has not been a particularly good year for Burzynski. While it’s true that his propagandist, whose first movie about Burzynski as a “brave maverick doctor” in 2010 took off in 2011 and brought Burzynski more fame and probably even more fortune, the sequel to the movie, Burzynski: Cancer Is A Serious Business, Part 2, although equally dishonest as the first Burzynski movie, appears not to have had nearly as much of an effect. Sure, Merola tried, trotting out all his old techniques and coupling them with ridiculously overblown attacks on “The Skeptics,” but it seems not to have stuck. Meanwhile, Dr. Burzynski’s ally in Japan, Dr. Hidaeki Tsuda, seems thus far unable to publish his randomized clinical trial of antineoplastons, much to the consternation of Burzynski apologists like Eric Merola. Meanwhile, a celebrity anecdote that was intended to prove to the world that Burzynski is the real deal fizzled as, sadly, the celebrity’s sister succumbed to her cancer, something that truly depressed me because palliative care would have been so much better.

Particularly curious is a series of press releases by the Burzynski Research Institute (BRI) and Burzynski Clinic in which Burzynski comments about some scientific issue or other. I took note of this phenomenon three or four weeks ago, when Burzynski commented on a rather interesting bit of cancer science—inanely, of course. I was wondering what this was about and why he would be issuing such pointless press releases. Maybe he got a new PR company, but for the life of me I couldn’t figure out why the BRI has been releasing such press release dreck in addition to its usual scientific dreck. I think I know now (and I know that several of you out there suspect and/or know why the BRI might be doing this), but bear with me a little while longer, because what the BRI is doing gets weirder, and it appears to be accelerating.

In just the last two or three days there have been at least five articles designed to highlight the Burzynski Clinic commenting about some cancer-related issue or study or other. They’ve been popping up on my Google Alerts, and readers have been sending one or the other of them to me. They include an article about breast cancer in young women (of course it is, this being October, which is Breast Cancer Awareness Month); an article about the Burzynski Clinic helping teens cope with parents’ cancer; an article about the risk factors for brain cancer; an article expressing “concern” about the “rise in 9/11 cancers”; and an article “questioning” whether aspirin can prevent colorectal cancer. The last article in particular is pretty disingenuous. The way it’s written seems to imply that the Burzynski Clinic had something to do with the research showing that aspirin can decrease the risk of colorectal cancer and other cancers. It didn’t. (Look at the first couple of sentences, “A new study shows that taking an aspirin every other day lowers the risk of colon cancer in women, say experts at Burzynski Clinic. In the study, women who took low dose aspirin every other day for 18 years had a 20 percent lower chance of developing colon cancer.”

There are other fishy things about these articles. For instance, look at the article on aspirin and colorectal cancer. Look at the author’s picture, a guy named Martin Jones. Does that picture look familiar to you? It should if you’re on Facebook a lot. Basically, it’s the face of every actor to play Batman in the movies morphed into a “perfect Bruce Wayne.” There are also a lot of other articles by “Martin Jones,” most unrelated to the BRI and all appearing to be a lot of public relations dreck. Now look at the story about 9/11 cancers. It’s supposedly written by someone named Mike Anderson. Look at his photo. Does it look familiar? Again, if you’re on Facebook a lot you might have noticed this very picture being passed around. It’s one of the “faces of tomorrow,” in which a photographer named Mike Mike travels to various cities and takes photos of 100 people there, after which he combines the faces to produce one male and one female individual. The photo of the “author” of the article about breast cancer in young women appears to be a stock photograph that shows up here and even seems to have his own Google Plus page. I suppose it’s possible that this is a real person, but it sure doesn’t look like it to me. Meanwhile, the photo used for the breast cancer article has clearly Photoshopped a stock image of a teen wearing a hoody and carrying a backpack into the foreground of the picture of the woman lying in the bed. The same teen appears here in a different pose, and the same photo appears here.

All this use of stock images and outright plagiarism are very bizarre, particularly given the inane (I know, I’m using that word a lot, but it fits too well) discussions in each press release. I had thought of discussing each press release in detail to deconstruct it, but then I thought: Why bother? Each release was obviously written by some hack, says nothing new, and, in fact, makes me wonder what kind of crappy PR company is behind this. All these sponsored links, plus the website that I mentioned before, smell very much like the work of an SEO “expert”—likely hired by the BRI and Burzynski Clinic. But why?

I rather suspect that this is the reason. What this is is a warning letter from the FDA to the Burzynski Clinic that was released right before the government shutdown. Links to it have been popping up all over Twitter, and a few of you have e-mailed it to me over the last several days. I didn’t blog about it because, well, I didn’t see anything new in it. However, perhaps I was wrong not to at least mention it, even if there wasn’t anything new. The reason is that this warning letter represents evidence that the FDA finally acted on the findings I blogged about in detail back in March, and it’s a much more digestible summary of the deficiencies found by the FDA than the FDA Form 483 was. So it’s worth a brief mention, as the BRI IRB has been dinged before many times in the past for the same sorts of violations described. This time the FDA dinged it for:

  1. The IRB failed to follow FDA regulations regarding expedited review procedures [21 CFR 56.110(b)].
  2. The IRB approved research without determining that the following criteria were met: risks to subjects were minimized [21 CFR 56.111(a)(1)]; risks to subjects were reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be expected to result [21 CFR 56.111(a)(2)].
  3. The IRB failed to determine at the time of initial review that studies involving children are in compliance with 21 CFR part 50, subpart D, Additional Safeguards for Children in Clinical Investigations [21 CFR 56.109(h)]. This is a repeat violation from our 2010 inspection.
  4. The IRB failed to prepare, maintain, and follow written procedures and maintain adequate documentation governing the functions and operations of the IRB [21 CFR 56.108(a), 21 CFR 56.108(b), and 21 CFR 56.115(a)(6)].

Once again, one violation in particular is particularly glaring, specifically Burzynski’s continued abuse of the expedited approval process through his IRB, and that’s his abuse of the expedited review process to sign up patients for single patient protocols (SPPs). The expedited review process generally involves approving things like minor revisions to research protocols and informed consent forms. Basically, from my reading back in March, I concluded that Burzynski seemed to be using the expedited review process to treat patients with antineoplastons who do not qualify for any of his numerous phase II trials. This FDA letter confirms it, stating bluntly, “Under FDA regulations, SPPs are not eligible for review via the expedited review procedure.” From my reading, this seems to be how Burzynski got around

I’ve said it before, and I’ll say it again, though: The central mystery behind Burzynski is how he’s gotten away with it for 37 years. It is the single question about Burzynski whose answer I want to know more than the answer to any other question about him before I die. Why does the FDA keep investigating him, finding serious violations, and giving him, in essence, a slap on the wrist? As I pointed out in March, just since 2000, he’s been investigated at least three times, and he’s received FDA warnings for his violation of human subjects regulations on multiple occasions before. This is simply the most recent. The last two times, Burzynski managed to resurrect his bogus clinical trials. This time, he’s been shut down for over a year in that there was a partial clinical hold placed on his pediatric trials in the summer of 2012 and that hold was extended to adult antineoplaston trials in early 2013. However, if he comes up with an answer that satisfies the FDA, he could conceivably have those same bogus trials resurrected yet again. Why doesn’t the FDA shut down any clinical trials done BRI and Burzynski Clinic permanently? Why doesn’t it at least shut down the BRI IRB, which would have the effect of shutting down the Burzynski Clinic because no reputable IRB would ever approve the clinical trials there? To get its scientifically dubious clinical trials approved, Burzynski needs an IRB run by an old crony of his from Baylor (Carleton Hazelwood) who just so happens to be the chairman of the board of BRI, a massive conflict of interest. Any other IRB with so many repeated violations and such a massively obvious conflict of interest would be shut down. Any other research institute with so many violations of FDA regulations would not be allowed to do clinical trials of any kind.

Yet the BRI persists. No matter how many times the FDA investigates it, no matter how many warning letters the FDA sends it, the BRI continues. In the 1990s, a powerful Congressman, Rep. Joe Barton, put serious pressure on the FDA through public hearings, the public dressing down of then-FDA director David Kessler, and who knows what behind-the-scenes pressure tactics to let Burzynski open clinical trials of antineoplastons. As Burzynski’s own lawyer put it, those trials were “all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment.” Since the FDA folded in response to Barton’s pressure in the 1990s, I haven’t heard news of Barton applying pressure to the FDA again over its investigations of Burzynski. True, the Republicans were in the minority during four years of the period since then, but even after they won the House back in 2010 I haven’t heard of any political pressure being brought to bear on the FDA. so I wonder: Is the FDA still so cowed from its previous experience that it can’t just pull the plug and shut Burzynski down completely?

It boggles the mind.