Dec 01 2011

Burzynski Tries to Distract and Intimidate

The shenanigans at the Burzynski clinic (a highly dubious cancer clinic in Texas) continue. I wrote recently about the attempt by one Marc Stephens who claimed to represent the clinic to intimidate science bloggers who have (appropriately, in my opinion) been sharply criticizing Burzynski for running a quack cancer clinic. The most slimy aspect of Stephens’ actions was to go after a high school student, Rhys Morgan, with legal threats. Rhys also lives in the UK where a libel suit, even if completely frivolous, can be ruinous. Stephens also sent a Google map image of Rhys’s house to Rhys – a not-so-subtle threat of physical violence against Rhys personally (“watch out, kid, I know where you live!”).

There was some speculation about whether or not Stephens really represents the Burzynski clinic, or perhaps he is just a rogue supporter, but that speculation has now been put to rest by a press release from the clinic. The document is worth some close scrutiny, as it is an excellent example of propaganda and how such dubious practitioners will try to distract from the real issues. Here is the press release:

The Burzynski Clinic is issuing the following public statement regarding recent internet activity between U.K. bloggers who have provided inaccurate information regarding the Clinic and Marc Stephens.
Marc Stephens was recently hired by the Burzynski Clinic as an independent contractor to provide web optimization services and to attempt to stop the dissemination of false and inaccurate information concerning Dr. Burzynski and the Clinic.

We understand that Marc Stephens sent a google map picture of a blogger’s house to the blogger and made personal comments to bloggers. Dr. Burzynski and the Clinic feel that such actions were not appropriate. Dr. Burzynski and the Burzynski Clinic apologize for these comments. Marc Stephens no longer has a professional relationship with the Burzynski Clinic.

These bloggers will be contacted by attorneys representing the Clinic informing them of the specific factual statements contained in these blogs which the Clinic believes are false and defamatory, including the following

A. Antineoplastons are made from urine. False – Antineoplastons are synthesized from chemicals

B. That Dr. Burzynski falsely claims to have a PhD. – False. In fact, Dr. Burzynski has a Ph.D. from the Medical Academy of Lublin and a copy of an official affadavit will be put up at the Burzynski Clinic website (www.cancermed.com).

C. There are no scientific studies supporting antineoplaston treatment since 2006. False – below is alist of publications and abstracts providing the results of the FDA-approved clinical trials since 2006 which demonstrate the treatment’s efficacy on a wide variety of brain tumors.

U.K. bloggers made factual misstatements about the clinic as a response to a funding campaign relating to a U.K. patient named Laura Hyman who was diagnosed with glioblastoma multiforme, a deadly form of cancer. She commenced treatment at the Clinic in August 2011. We are happy to report that Laura is doing well on antineoplaston treatment and that her tumor is shrinking. Her personal blog about her treatment by the Burzynski Clinic is at www.hopeforlaura.com.

Eleven (11) phase II FDA-approved clinical trials using antineoplastons for various forms of brain tumors have been completed. Based on the positive results the FDA has granted permission to undertake phase III clinical trials. The results fo these trials are detailed in the Burzynski Research Institute’s SEC (Securities and Exchange Commission) filings available at (http://finance.yahoo.com/q/sec?s=bzyr.ob)

Contact: Renee Trimble, Director of Public Relations

The first paragraph gives us a pretty clear image of what happened. Stephens was a hired pit bull given the task of stopping legitimate criticism of Burzynski and his clinic online. Now that this blew up in their faces, Burznyski is trying to distance himself from Stephens and essentially throw him under the bus. How did he think Stephens was going to silence the criticism? Through careful scientific argument? Stephens is a “web optimization” consultant, not a medical expert. It seems to me that Stephens did exactly what Burzynski expected him to do – go around threatening any blogger who dared point out that Burzynski just might be  a quack. It’s also likely that the details were left to Stephens, and it is also likely that Burzynski did not anticipate or know about sending the picture of Rhys’s house. But you can’t be too shocked that when you hire a pit bull to attack your critics that they might bite someone.

The core of the press release is a series of distractions from the real issues. This is a common tactic – pick on trivial or incidental issues as if that undermines the credibility of your critics, and ignore the meat of their criticism. Let’s go through these one by one. The press release states:

A. Antineoplastons are made from urine. False – Antineoplastons are synthesized from chemicals

The issue of how “antineoplastons” are made is quite irrelevant to the question of whether or not they are safe and effective for the treatment of any type of cancer. Some blogs mentioned as an aside that Burzynski first purified the peptides from urine, and most actually got this correct – that the peptides “can be” purified from urine, or were “originally” obtained from urine. Burzynski misrepresents these claims as if they were specifically stating that he currently obtains these peptides from urine. Most blogs didn’t bother going into these details, because they are mostly irrelevant.

The press release, however, is misleading – implying that the link to urine is completely false, and failing to mention that Burzynski originally identified and obtained them from urine. Saul Green posted an analysis on Quackwatch that gives the whole biochemical story of “antineoplastons”. He wrote:

In reality, AS-2.1 is phenylacetic acid (PA), a potentially toxic substance produced during normal metabolism. PA is detoxified in the liver to phenylacetyl glutamine (PAG), which is excreted in the urine. When urine is heated after adding acid, the PAG loses water and becomes 3-N-phenylacetylamino piperidine 2,6-dione (PAPD), which is insoluble. Normally there is no PAPD in human urine.

I recommend you  read the whole article – it puts Burzynski’s claims into a nice perspective. He has simply isolated proteins excreted in urine, messed around with them a little, and renamed them “antineoplastons.” In essence these are drugs that he is administering as chemotherapy. They have toxicity. There is no basic science reason to suspect they will have anti-cancer properties, and more than 30 years after Burzynski first started making claims for these peptides there is still no credible evidence that they are of any therapeutic value against cancer.

This is the basis of the criticism against Burzynski – not just the mere fact that the peptides are obtained from urine. And it matters not at all that he can now synthesize them from chemicals. The goal, of course, was just to be able to print the word “false” after a claim allegedly made by his critics (and he had to distort that claim, at least for most of the blogs I read, in order to do that).

Next up:

 That Dr. Burzynski falsely claims to have a PhD. – False. In fact, Dr. Burzynski has a Ph.D. from the Medical Academy of Lublin and a copy of an official affadavit will be put up at the Burzynski Clinic website (www.cancermed.com).

Again – not exactly what the bloggers have been saying. The original blog post criticizing Burzynski and to draw the ire of Stephens had this to say:

The website Quackwatch has raised concerns about the origin of Burzynski’s claimed PhD.

“Raised concerns” is not the same thing as making a direct claim that Burzynski does not have a PhD. What were those concerns? Saul Green investigated and found:

  • An official from the Ministry of Health in Warsaw informed me that when Burzynski was in school, medical schools did not give a Ph.D. [1].
  • Faculty members from at the Medical Academy at Lubin informed me that Burzynski received his D.Msc. in 1968 after completing a one-year laboratory project and passing an exam [2] and that he had done no independent research while in medical school [3].
  • In 1973, when Burzynski applied for a federal grant to study “antineoplaston peptides from urine,” he identified himself as “Stanislaw Burzynski, M.D, D.Msc.” [4]

Those sound like reasonable concerns. Burzynski promises an affidavit on his website, but so far it is not in evidence. And again – this is a side show. If his research were legitimate no one would  worry about his credentials. But since he is presenting himself as a “medical pioneer” it is reasonable to see if he is being dishonest about his credentials.

And finally:

C. There are no scientific studies supporting antineoplaston treatment since 2006. False – below is alist of publications and abstracts providing the results of the FDA-approved clinical trials since 2006 which demonstrate the treatment’s efficacy on a wide variety of brain tumors.

Again, not exactly true. It was pointed out that there does not appear to be any published studies since 2006. If you do a PubMed search for Burzynski or antineoplastons you will see this to be true. But Burzynski has a list of “studies” since 2006 that are not published in the peer-reviewed literature. They are mostly case reports and review articles presented as abstracts at meetings or published in non-peer-reviewed sources.

This is another distraction – distorting the actual points being made to make them seem false. The point of this is that Burzynski claims to be doing clinical research on antineoplastons. That is how he is able to use a non-FDA approved drug to treat cancer – he claims he is conducting clinical trials. Of course, he still charges his “subjects” up to hundreds of thousands of dollars for the privilege of being in his study.

This all seems like a dodge to get around the FDA, and the fact that it has been 5 years without a single publication in the peer-reviewed literature is curious. Tossing out a few case reports and reviews is not really evidence of major clinical research going on.

It is also very telling what is not in the press release – addressing the many serious concerns about Burzynski’s claims, the lack of science behind his practice, and the fact that more than 30 years on he is still doing preliminary type studies, not the kind that can truly determine if his “antineoplaston” treatment is worth the piss it used to be made from.

It is also clear from the press release that, while he is distancing himself from Stephens, he still wishes to continue to intimidate bloggers, especially in the UK. I wonder why he singled out the UK bloggers. Perhaps it has something to do with the ridiculous libel laws there.

The intimidation is not going to work. In my opinion Burzynski has been exploiting desperate cancer patients for years with dangerous pseudoscience. He has a lot to answer for, and I am glad to see that the science blogging community is holding his feet to the fire, and won’t be intimated by some hired internet thug.

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16 responses so far

16 Responses to “Burzynski Tries to Distract and Intimidate”

  1. Todd W.on 01 Dec 2011 at 11:38 am

    Anarchic Teapot has raised some questions about the financial goings-on at the Burzynski Clinic, as well, over at his blog. I’m also very curious to see any of the FDA authorizations he has received allowing him to charge subjects to be in his clinical trials. They must exist, otherwise, he’d be breaking the law. Similarly, I’d really like to get a look at some of the consent forms for his trials to see if subjects are being adequately informed of everything, especially since the IRB for the Burzynski Research Institute received a warning letter from FDA in 2009 that still has not been closed, indicating that no corrective actions have been implemented by the IRB.

  2. Karl Withakayon 01 Dec 2011 at 11:49 am

    “That is how he is able to use a non-FDA approved drug to treat cancer – he claims he is conducting clinical trials. Of course, he still charges his “subjects” up to hundreds of thousands of dollars for the privilege of being in his study.”

    After following this story for a while now, a thought has just occurred to me. However unethical it is to charge people for participating in trials (essentially a backdoor to charging for an unapproved drug), those “trials” obviously can’t be randomized, placebo controlled studies, or it would be beyond unethical to charge people for participating.

    Rhetorical question: What value can those “trials” claim to have in regards to determining the efficacy and safety of the treatment?

  3. daijiyobuon 01 Dec 2011 at 12:25 pm

    @Karl:

    Hmmmm, and an awful lot of ‘self-selection’ going on by both the ‘investigators’ and the patient-participants.

    -r.c.

  4. Todd W.on 01 Dec 2011 at 12:52 pm

    @Karl Withakay

    Good point! Wish I’d thought of it. So, no randomization, which decreases the scientific validity of the trial. If he does randomize and charges the control group the same amount, then he is violating FDA regulations, since the regs only allow billing for the cost to manufacture/acquire the drug (i.e., direct costs), nothing else.

  5. leoneton 01 Dec 2011 at 1:08 pm

    Everyday, I work with people who labor over every detail of clinical trials to make sure that informed consent, clinical equipoise and data integrity regulations are met. It’s literally hard to believe that the FDA tolerates such flagrant violations of these norms at this “clinic”.

    Are their hands are tied by some onerous legal technicality?

  6. specialkon 01 Dec 2011 at 1:27 pm

    All the trials Dr B is running are phase 2 – these are not necessarily required to be randomised.
    CancerHelp UK says;
    Not all treatments tested in a phase 1 trial make it to a phase 2 trial. Phase 2 is sometimes written as phase II. These trials may be for people who all have the same type of cancer, or who have several different types of cancer. Phase 2 trials aim to find out

    * If the new treatment works well enough to test in a larger phase 3 trial
    * Which types of cancer the treatment works for
    * More about side effects and how to manage them
    * More about the best dose to use

    Although these treatments have been tested in phase 1 trials, you may still have side effects that the doctors don’t know about. Drugs can affect people in different ways.

    Phase 2 trials are often larger than phase 1. There may be up to 100 or so people taking part. Sometimes in a phase 2 trial, a new treatment is compared with another treatment already in use, or with a dummy drug (placebo). If the results of phase 2 trials show that a new treatment may be as good as existing treatment, or better, it then moves into phase 3.

    >>>>
    So you’re looking for dosage, toxicity and any inklings of efficacy. The trials aren’t actually designed to show true efficacy – you need phase 3 for that. After 2,000 patients treated in the past 10 years (according to the clinic website) you have to ask why he doesn’t have enough data to show that he is ready for phase 3.

    There is one phase 3 trial meant to be starting this year. But the paucity of convincing data after so many years of trials is rather suspicious. If there was significant evidence of efficacy (assuming his methodology is capable of showing it, which is highly doubtful based on previous criticisms of his trials http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page5) then he could licence it to a pharma company (or even set up his own) and make $$$$$$$$$.

    As he hasn’t, one can only ask questions as to why. And at the prices that his clinic is charging to take part in the trials (although he doesn’t charge for the actual drug, he charges for pretty much everything else around it), there is a fairly obvious answer.

    Incidentally, I wonder how many of his success stories are actually down to chemotherapy? http://www.burzynskiclinic.com/treatment-options.html

  7. Kawarthajonon 01 Dec 2011 at 2:50 pm

    I just read Rhys Morgan’s blog and the posts about this topic. I was very impressed with his tenacity and his responses to Marc Stephens – I would imagine that he will make a big name for himself as a sceptic in the future. It’s good to see him stand up to the bullying.

  8. HHCon 01 Dec 2011 at 5:02 pm

    I would file this FDA case under Bed, Bath, and the Great Beyond. While the patient is getting ready for the hospital bed, the Doctor of Metaphysics takes a bath in the patient’s money, whilst the patient moves to the Great Beyond.

  9. Enzoon 01 Dec 2011 at 6:11 pm

    A quick look at clinical trials (ongoing and concluded) with the search term “antineoplaston” will pull up Burzynski’s stuff. Over 60 trials, apparently. The phase III trial is not currently open, but it is scheduled to begin this month (Dec 2011).

    Link here:
    http://www.clinicaltrials.gov/ct2/show/NCT01260103?term=antineoplastons&rank=1

    You can see what arms are included in the trials. For the phase III study, at least, temozolomide treatment is used as the comparator. This is pretty standard for gliomas. They don’t publish the protocol for these things, so I’m not sure if the 70 people this trial is aiming for are going to be receiving the standard of care in addition to Burzynski’s “combination antineoplaston therapy” (as is the case for most new anti-cancer agent potentials). The trial summary does state all enrolled patients will have gone through standard chemo (cisplatin).

    I’m confused, though. Do antineoplastons have a previously established safety profile? Cancer therapeutics do have several special cases applied to them when it comes to FDA new drug applications and clinical trial approval, but I don’t see how studies like this have been approved in the absence of good pre-clinical evidence. Any insight into how this has progressed to Phase III?

    For the record, the trial information has “No publications provided ” for additional information (to be fair, though, this isn’t uncommon) and Burzynski is listed as the principle contact as “Stanislaw R Burzynski, MD PhD”

  10. SARAon 01 Dec 2011 at 9:46 pm

    The distraction of the nitpicking is a nice lesson in being specific, rather than vague when you are exposing someone like this.
    He finds it easy to choose items that can marked as “false” in technicality and that is all that someone who is inclined to believe him needs to see.
    They now have confirmation that those who made these statements are wrong.
    His supporters will now look no further and people on the fence will feel less inclined to trust your side. From now on, both sides will be preaching to the choir as they battle it out.

    You either make the point specifically right the first time or you lose your advantage in converting those who support him or are on the fence.

  11. specialkon 02 Dec 2011 at 4:52 am

    Interestingly, this account (http://kassidysroadtorecovery.blogspot.com/2011/06/june-28-2011.html) seems to say that dr B is giving someone “targeted treatments” (ie cancer drugs – usually-abs or -ibs – see the FDA list linked to from Burzynski’s own website http://www.burzynskiclinic.com/treatment-options.html).

    But all his open trial protocols bar one say that no other immunotherapy treatment or anti-cancer drugs should be used (http://clinicaltrials.gov/ct2/results?term=%22Burzynski+research+institute%22&recr=Open). So how the hell can you tell if the antineoplastons are working, if you’re giving someone chemo (which is what these targeted drugs are) as well? They may not be traditional cytotoxics, but they’re still very potent drugs with a significant side-effect risk.

    There is something extremely fishy going on here.

  12. eiskrystalon 02 Dec 2011 at 5:45 am

    Antineoplastons are made from urine. False – Antineoplastons are synthesized from chemicals

    Oh my god, you mean they aren’t “natural”?!?

    Never thought i’d see a quack pulling that reverse.

  13. specialkon 02 Dec 2011 at 6:31 am

    Also this account here – patient getting $$$ chemo that her own “evil” oncologist won’t recommend, and antineoplastons on top:
    http://adventureandhope.blogspot.com/2011/11/doctors-or-as-our-oncologist-at-kaiser.html

  14. Steven Novellaon 02 Dec 2011 at 8:52 am

    Sara – you are correct, but with any complex issue it is very difficult to be ironclad. If someone is not playing fair and is dedicated to finding something to nitpick, and is willing to distort what you say, it is almost impossible to shield yourself against it. But you do certainly want to make it more difficult to do so.

  15. specialkon 02 Dec 2011 at 10:23 am

    Interesting post here from a UK family going through treatment at the clinic – paying $$$$ in hidden and unexpecetd costs. Uttrely shocking:
    http://supatrascancerfight.blogspot.com/2011/10/info-for-new-burzynski-patients.html

  16. SARAon 02 Dec 2011 at 7:04 pm

    Steve,
    I hope you realized that I was not referring you specifically, but the “universal” you of all of us. I could have worded that better.

    You’re probably right, it would be nearly impossible to avoid the professional nitpicker, no matter how hard one tried. Particularly, since ethics is not impeding their efforts and it would be impeding the skeptic (at least I hope it would).

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