Respectful Insolence

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 The reason is that all the skeptical literature on Burzynski and his dubious cancer cures was way out of date, at least from a scientific standpoint.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 BurzynskiClinic.net 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.

Comments

  1. #1 oldmanjenkins
    Wooville Florida
    October 4, 2013

    It appears the BRI PR machine has taken the weird dial and turned it up to 11!

  2. #2 Eric Lund
    October 4, 2013

    A new study shows that taking an aspirin every other day lowers the risk of colon cancer in women, say experts at Burzynski Clinic.

    That’s rather brazen of them. Of course the sentence doesn’t say this, but people who are used to science news and who read this sentence would reasonably assume that the Burzynski Clinic was involved with, if not the lead institution on, the study in question. And if the actual lead institution were to challenge them on that point, the Burzynski Clinic could parse that sentence as saying, “This is our experts’ view of the study.”

    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?

    The pressure doesn’t need to be overt, particularly if Barton is on one of the relevant committees. Just the occasional “friendly” reminder when the appropriations bill that covers the FDA is being marked up in committee would deter the FDA. I’m sure the FDA would prefer not to go through another such hearing, especially with Barton and his friends determining what witnesses are called–the House Republican caucus has a well-deserved reputation for hostility to science, so the FDA would be made to look bad, regardless of the actual facts.

  3. #3 anarchic_teapot
    October 4, 2013

    I saw 3 of those articles, pointed oput by a Twitter friend, and wondered about the photographs, since the “correspondents” were clearly fake: all create accounts and start posting at the same time, on the same “news” network… Well, that clears it up beautifully. Thanks.

  4. #4 Woo Fighter
    October 4, 2013

    i saw someone post on Twitter (might have been MedTek, perhaps she’s reading this and can confirm?) that the aspirin study story was lifted verbatim from somewhere else, and the only changes were the substituted references to “Burzynski Clinic” replacing the name of the original source.

    I’ve looked back over Twitter posts but was not able to find the reference and the link to the plagiarised study, but I will keep looking.

  5. #5 MedTek
    October 4, 2013

    Not lifted verbatim, but large swathes of it, yes. I wonder if Dr. Nancy Cook, whose work this is, is aware that someone else is suggesting credit for it?

  6. #6 MedTek
    October 4, 2013

    This is the one that gets me:

    “In addition, the IRB member who granted the majority of these approvals, IRB Vice-Chairman Gary L. Harvey, was a community (i.e., nonscientific) member of the IRB with a Master’s degree in Business Administration. According to the IRB roster submitted with your February 28, 2013, written response, Mr. Harvey is self-employed in water rehabilitation services; therefore, he does not have the clinical expertise necessary to make the required informed evaluation of the risks to subjects and their reasonableness in relation to anticipated benefits.”

    So basically this guy with an MBA working in water rehabilitation was approving the administration of this toxic substance to small children (and other very sick people)?

  7. #7 Tim Farley
    http://skeptools.com
    October 4, 2013

    Skeptics who are interested in duplicating the fine detective work of MedTek et.al. who tracked down those stock photos being used for authors, would be well served to read this piece I wrote on reverse image search.

    With the right plugin installed in your browser, it is literally as easy as a right click on the offending image.

  8. #8 Tim Farley
    http://skeptools.com
    October 4, 2013

    On a related note, if you are trying to investigate whether an article similar to the ones mentioned here has plagiarized hunks that may have come from press releases or even Wikipedia, I recommend using this site: http://churnalism.sunlightfoundation.com/

  9. #9 Orac
    October 4, 2013

    Actually, I just used Google image search and found the images. :-)

  10. #10 Mark Thorson
    October 4, 2013

    Can’t Tsuda get published in one of the journals discussed here? All you need is a credit card.

    http://www.sciencemag.org/content/342/6154/60.full

  11. #11 Tim Farley
    http://skeptools.com
    October 4, 2013

    Yes, Google Image search is what my blog post is about – with a small caveat that sometimes left-right reversing the photo first, then searching it can find things that Google wouldn’t normally turn up. Also a note that there are plugins for Google Image search and TinEye that put it a right-click away, making it even easier.

  12. #12 Krebiozen
    October 4, 2013

    Orac,

    Why does the FDA keep investigating him, finding serious violations, and giving him, in essence, a slap on the wrist?

    I have wondered this too. I think it’s because most of Burzynski’s patients are terminal, at a point where conventional medicine has nothing but palliative treatment to offer. Telling patients whose conditions are hopeless that they can’t have one more desperate throw of the dice perhaps seems cruel to the FDA.

    Of course a small number of patients labeled as terminal survive, and a number turn out to have been successfully treated with late response to radiotherapy they received before seeing Burzynski and pseudoprogression leading to the appearance of success in some patients*. I suspect it is this appearance of possible success that has stayed the FDA’s hand in the past.

    * Of course there is always the small possibility that Burzynski’s treatments are effective, but in the absence of any comprehensively published results, we don’t know and can only speculate that if he could prove they work he would have done by now.

  13. #13 Dangerous Bacon
    October 5, 2013

    “I think it’s because most of Burzynski’s patients are terminal”

    Do we have enough information on his patients to confidently say this? I certainly have heard of people going to his clinic who could not be described as terminal. Some are hoping for what they think will be a safer alternative to standard treatments.

  14. #14 Krebiozen
    October 5, 2013

    Dangerous Bacon,
    I’m not certain, to be honest, though almost all the patients’ cases I have looked at were terminal. I suspect he may be treating more non-terminal cases and more non-brain -cancers recently, with his “personalized gene-targeted cancer therapy for dummies” as Orac calls it. Or has he always treated a range of cancers, but his glioma patients get more attention?

  15. #15 Delurked Lurker
    On a pale blue dot suspended in a sunbeam
    October 5, 2013

    Boogles the mind indeed Orac

    I am looking forward to the day when you post that Bullshitski has been shutdown and booted out of the US, mind you I am not holding my breath.

    That will be a great day :)

  16. #16 Tdoc
    October 5, 2013

    I am not sure that lumping AGW denialists with the others is really fair. I am pushing 70 now and remember quite well being told by the Ecologists in the ’60s and ’70s that we were facing an ICE AGE!!! if we didnt mend our ways. Now we are facing a heat wave, except that there has been no change in the global temps in 20 years and the ice caps are in great shape. Oh, and the 3d world is happy to take up any carbon we leave behind and use it to benefit their ecomomies as we crush our own. The AGW people seem to me to be more cult like in their refusal to debate or discuss and the true skeptics seem to be the AGW deniers.

  17. #17 herr doktor bimler
    October 5, 2013

    I am pushing 70 now and remember quite well being told by the Ecol

    Wrong thread, but never mind.
    I too was paying attention in the 60s and 70s and I do not remember such warnings. There was science populariser Nigel Calder in “The Weather Machine” in 1974… and “the return of the glaciers” was a popular trope among sf writers. Care to cite ‘the Ecologists’ by name?

    there has been no change in the global temps in 20 years
    B0llocks.

  18. #18 Krebiozen
    October 6, 2013

    Tdoc,

    the ice caps are in great shape.

    Not on this planet they’re not:

    Overall, 10.03 million square kilometers (3.87 million square miles) of ice were lost between the 2013 maximum and minimum extents. This was the seventh summer that more than 10 million square kilometers of ice extent were lost; all but one of the seven (the summer of 1990) have occurred since 2007.

  19. #19 Lawrence
    October 6, 2013

    @Kreb – according to the latest reports, not only is the total area shrinking, but the ice the remains is much thinner than it has been in the past…..

    Bad signs for the future.

  20. #20 Narad
    October 6, 2013

    I too was paying attention in the 60s and 70s and I do not remember such warnings.

    Probably for good reason.

  21. #21 Militant Agnostic
    On a planet where we obey the laws of themodynamics
    October 7, 2013

    @HDB

    I too was paying attention in the 60s and 70s and I do not remember such warnings.

    It has been said that if you remembered the sixties you weren’t there.

    I do recall alarmist headlines in the Rocky View News (a rural weekly distributed free to residents of the Municipal District of Rocky View) about a coming ice age during that time period. The editor, one Leif Ericson (who was definitely not related to Eric the Red) seemed to have bee in his bonnet about this.

  22. #22 zab
    October 15, 2013

    I think the only rational explanation is that Tdoc has slipped into our timeline from a parallel dimension. In the other timeline, the ice caps are still in good shape, and global cooling is the prime ecological threat. In order to counter-act this threat, the scientist have been pumping carbon-dioxide into the air, hoping to prevent the next ice age from wiping out all life on the planet.

  23. #23 Calli Arcale
    October 15, 2013

    Militant Agnostic: I’ve been enjoying getting a new/old Doctor Who fix by watching serials which are 45 years old but which I’ve never seen. One was “The Ice Warriors”, which came out on DVD after most of its episodes were rediscovered and the remaining missing episode replaced with animation. (The soundtracks for all episodes still exist, in one form or another.) The story revolves around a time in the future when Earth is threatened by an advancing ice age, and a device called an ionizer is being used to keep the glaciers at bay so that crops can be grown and humanity can remain prosperous. Somewhat amusingly, the crisis is attributed to a lack of CO2 in the atmosphere due to deforestation; the former is based in science, while the latter seems to demonstrate a rather serious misunderstanding on the part of the scriptwriter. I don’t think even in the 60s any biologist seriously thought plants made CO2.

  24. #24 Lawrence
    October 15, 2013

    @Calli – also, the last BBC update of “Day of the Triffids” explored a similar concept – that the Triffids were being harvested as an alternative fuel source & because of the lack of pollution (fossil fuels were replaced) there was a lot of concern around climate change from “global cooling.”

  25. #25 Narad
    October 15, 2013

    the last BBC update of “Day of the Triffids” explored a similar concept

    If you’re going to play that card, I just finished reading John “Tripods” Christopher’s The World in Winter. It’s a straight lack-of-insolation routine, with a bit at the end about anticyclones now making England dry and clear enough to try to grow potatoes or something. The part I can’t figure out is why Nigeria is preparing for tank battles with South Africa.

  26. #26 Khani
    October 15, 2013

    … wait, you need a *reason* for tank battles?

    Darnit, there goes my weekend.

  27. #27 sherri dudek
    usa
    December 15, 2013

    I think it is OUR BODY..OUR CHOICE…someone doesn’t want chemo or radiation in the conventional manor or do nothing at all, it is their choice….just as it is their choice to try antiplastons…
    Why should it matter to anyone but the person incharge of their own body. You are all paid by the big pharm guns. If one of them came up with this and hospitals made money on it there would be this option available also…