Respectful Insolence

It’s been a long time, been a long time, been a long lonely, lonely, lonely, lonely time.

Well, not really, although it has been a while since I’ve discussed Dr. Stanislaw Burzynski. Specifically, I last dedicated a post to him following the death of one of his famous patients, Billie Bainbridge, who incidentally had become famous because her family had managed to raise hundreds of thousands of pounds with the help of some U.K. celebrities. Burzynski, as regular readers will recall, became a frequent topic on this blog last fall after one of his lackeys decided to issue vacuous legal threats against skeptical bloggers who had called attention to his activities. These activities have included administering an unproven therapy that he calls antineoplastons to patients under the auspices of dubious clinical trials that appear mysteriously rarely to accrue sufficient patients and have not produced significant publications in several years. (Not that Burzynski’s earlier publications were ever particularly impressive.)

In the process, he developed a cult of personality, in which his false promise of “natural” and “non-toxic” therapy that can cure the incurable, has attracted desperate cancer patients from all over the world, as long as they can come up with the tens (or hundreds) of thousands of dollars that the Burzynski Clinic charges. It’s also managed to blind journalists, who should normally be a lot more skeptical, to the unethical nature of what he is doing. Mixed in with antineoplastons, Burzynski also claims to have cracked a nut that world-renowned cancer centers have yet to crack, specifically providing “personalized, gene-targeted cancer therapy” that works. Burzynski’s “personalized” therapy also puts the lie to the claim that his therapy is natural, because, as I explained before, based on the results of a commercial test Burzynski uses very expensive chemotherapeutic drugs and targeted therapies, all of which have significant toxicity. As I pointed out before, Burzynski doesn’t know what he’s doing; what he’s really doing is “personalized cancer therapy for dummies,” as I’ve put it before. Moreover, in doing so, he’s managed to co-opt an orphan drug.

So why am I revisiting Burzynski? After all, nothing much new is happening that hasn’t been happening for the last 30 years, particularly since legal maneuvering has delayed his appearance before the Texas Medical Board to determine whether he should be stripped of his license. Rather, I was made aware of a post by Keir Liddle entitled Investigating Burzynski, which revealed documents that I hadn’t seen before related to Burzynski’s activities. True, the documents are about a decade old, but they reveal some truly disturbing things about how Burzynski operates. In particular, they strongly suggest that Burzynski operates in much the same way that vaccine/autism quacks Mark and David Geier operate when doing their “clinical research.”

What has always been puzzling to me, ever since I became interested in Burzynski and his antineoplastons, is why Food and Drug Administration (FDA) not only continues to let Burzynski set up phase II clinical trial after phase II clinical trial, nearly all of which never accrue enough patients to publish. The last time I checked, there were over 60 clinical trials listed on ClinicalTrials.gov under Burzynski’s name. There still are. Even more puzzling to me is why the FDA apparently approved a phase III clinical trial of antineoplastons (A Randomized Study of Antineoplaston Therapy vs. Temozolomide in Subjects With Recurrent and / or Progressive Optic Pathway Glioma). The trial was submitted in December 2010 and is not yet open for recruitment, which strikes me as a rather long time given that the study start date was listed as having been scheduled to be December 2011. The study was then to have run until December 2015. In any case, the reason that this is an issue is that Burzynski apologists have been pointing to this study as “evidence” that there must be something to antineoplastons, the rationale being that otherwise the FDA would not have given the trial the go-ahead. Given that there is no good clinical data published by Burzynski that I’ve been able to find to support a phase II clinical trial, this has puzzled me and other skeptics, at least one of whom suspects that, however he persuaded the FDA to approve this trial, it suits Dr. Burzynski just fine that it has not opened yet. It is a suspicion that I share. Think about it. This phase III trial is the biggest and most effective club that Burzynski apologists have to beat skeptics over the head with. If Burzynski actually started accruing to the trial, its results would, by law, have to be posted to ClinicalTrials.gov. An approved but not yet accruing trial is an infinitely better weapon than a trial that accrues and produces no results. It’s also interesting to note that this clinical trial includes chemotherapy.

Be that as it may, what interested me the most were three documents: a letter to the Burzynski Clinic Institutional Review Board (IRB) from 2001; a report of a site visit to the Burzynski Clinic by the FDA Southwest Regional/District Office, Dallas District; and a warning letter from the FDA’s Human Subjects Protection Team, Division of Scientific Investigations, Office of Compliance dated 2009.

The first thing that leapt out at me is an offense that, to my mind, is identical to the offense committed by Mark and David Geier. Basically, the chair of the Burzynski Research Institute IRB is Carlton F. Hazlewood, PhD, who just so happens to be on the board of directors of the Burzynski Research Institute. Given that the Burzynski Clinic is trying to commercialize antineoplastons, this is a profound conflict of interest. Think of it this way: What would Burzynski’s defenders say if they found out that a sitting member of the board of directors of Merck, for example, was serving on the IRB that approves Merck’s clinical trials? This is the same thing. True, it’s not quite as bad as having the principal investigator of a study sitting on the IRB that approves his study, as Mark Geier has done, but it’s still quite dubious.

And there’s more, unfortunately, so much more. For instance, this report lists the following deficiencies:

  • Enrollment of subjects into antineoplaston study protocols prior to the protocol-specified interval following prior chemotherapy and/or radiation therapy.
  • Failure to report all serious adverse events (SAEs) and adverse events (AEs) to the agency and/or IRB.
  • Failure to follow proper informed consent procedures.
  • Failure to maintain adequate drug accountability records.
  • Discrepancies between case report forms and source documents.

Of note, there is another interesting admission in the report as well, specifically:

He [Burzynski] stated that the majority of prospective patients that present to the clinic do not qualify for entry into a study protocol and, therefore, are treated with traditional FDA-approved drugs/treatments; i.e., radiation or chemotherapy. Dr. Burzynski then added that approximately [REDACTED] of his patients were treated with antineoplastons.

Later, Burzynski admitted:

I asked Dr. Burzynski what other treatments are offered/done/given at his clinic. He stated that all other treatments are FDA-approved treatments, such as chemotherapy or radiation therapy.

Wow! I wonder if Suzanne Somers knows about this. Do Burzynski’s alt-med apologists know about this? Burzynski actually told FDA inspectors that he uses FDA-approved chemotherapeutic drugs for most of his patients. I also wonder if they know about some of the SAEs reported, such as hemorrhagic cystitis, serious diarrhea, pancreatitis, central line sepsis, pneumonia, renal acidosis, and even death. These are SAEs that weren’t even reported, as well. Whether they weren’t reported because Burzynski was intentionally hiding them or because he and his medical staff were clueless about what constitutes an SAE that must be reported, I don’t know. Even more amazingly, Dr. Burzynski didn’t seem to know that tumor measurements had to be reported on case report forms!

This report describes Burzynski IRB operations, including quite a few deficiencies:

  • Failure to keep a copy of the study protocol and informed consent form.
  • Failure to receive and/or require progress reports from the principal investigator for the study.
  • Failure to receive and/or require a final report from the principal investigator for the study prior to removal from the IRB’s active list of studies.
  • Failure to assure that FDA approval was obtained by the principal investigator for the study prior to the treatment of a patient under a special exception.
  • Approval of special exceptions via expedited review.

What I’d really like to know is who is on the Burzynski IRB. For instance, if Dr. Hazlewood, who has a massive conflict of interest, was allowed to serve as IRB chair since 1993, who else on the IRB has a conflict of interest? Inquiring minds want to know! They also want to know how, seven years later, the same problems (and even worse ones) were still going on at the Burzynski Research Institute and the Burzynski Clinic, as enumerated in this FDA warning letter:

  • The IRB approved research without determining that the following criteria were met: That risks to subjects were minimized and That 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.
  • The IRB Failed to prepare, maintain, and follow written procedures for conducting its initial and continuing review of research.
  • The IRB failed to ensure that informed consent would be sought from each prospective subject or the subject’s legally authorized representative.
  • The IRB failed to ensure that no member participated in the initial or continuing review of a project in which the member had a conflicting interest.
  • The IRB failed to conduct continuing reviews.

And, as mentioned before, Dr. Hazlewood has a massive conflict of interest:

For the (b)(4) study, you (IRB Chairman, Carlton F. Hazlewood, Ph.D.) are listed as a clinical investigator on the “Certification: Financial Interests and Arrangements of Clinical Investigators”; you are also listed as being an ex-officio advisor to the (b)(4)/IBR Central Registry Control Committee/Data Monitoring Committee. Therefore, you had a conflict of interest.

Minutes of the August 8, 2008 IRB meeting indicate that you attended this meeting and participated in the discussion of the (b)(4) study. At this meeting, the IRB voted to draft a letter to (b)(4) to inquire about the status of the animal toxicity studies. According to the minutes, all members were in favor, none were opposed, and none abstained. Minutes of the October 24, 2008 IRB meeting indicate that you attended the meeting and participated in the discussion of the (b)(4) study. At this meeting, the IRB voted to draft a letter to (b)(4) informing them that their application was on hold. The vote on this action is recorded as unanimous; therefore, according to the minutes of these two IRB meetings, you participated in the review of this study and voted on it even though you had a conflict of interest. We also note that you signed off on all correspondence sent by the IRB to Dr. (b)(6) and the sponsor in regard to this study.

And:

Our inspection revealed that, in some instances, when an IRB member had a conflict of interest for a particular study, another person, who was not an IRB member, was allowed to take the place of the conflicted member and participate in the IRB’s action. There is no provision in FDA regulations for this type of action.

In other words, the IRB played fast and loose with its membership roster.

Talk about the fox guarding the chicken coop! Is anyone willing to bet that there’s more than just this? This is the conflict of interest that could be documented on paper, a COI for which Hazlewood screwed up. I’d be willing to bet that Hazlewood has his hooks in many of Burzynski’s studies, just not as a co-investigator of one study. After all, he’s worked for Burzynski since the early 1980s and has been IRB chair since 1993. At the risk of being repetitive, I think it’s absolutely appropriate to point out one more time that Burzynski’s fans would go absolutely nuts if they discovered that a scientist who is listed as a co-investigator on a study for a drug company served on the IRB overseeing his study not just as a member, but as the chair of the committee!

OK, OK, I’ll stop now. I realize I might be pounding this point too hard. I hope you’ll understand, though. Being a clinical investigator myself, my mind just boggles thinking about this, and I can’t comprehend how Burzynski and Hazlewood have been able to get away with playing fast and loose with human subjects protection rules at least since the 1990s. I just can’t. That the FDA apparently approved a phase III clinical trial for any disease at the Burzynski Clinic after finding these violations is something I have even more trouble understanding. I’ve heard of whole medical schools being in danger of having their ability to do clinical research shut down until they corrected violations this serious; yet somehow Burzynski continues.

Comments

  1. #1 Darwy
    Røde grøde med fløde
    August 16, 2012

    I don’t get it.

    Seriously, how can people buy his brand of BS and claim it to be ambrosia?

    For all they scream, “COI BIG PHARMA!!!!EleventyOnE!!” They see what Burzynksi does as ‘situation normal’.

    Is it that they have some idealistic image of Burzynski as a neo-jesus figure who is leading them from the evil valley of Pharma into the promised alterna-land?

    They need rubber romper rooms.

  2. #2 Lawrence
    August 16, 2012

    If information like this came out regarding a normal “Pharma” company, you can guarantee that the woo-meisters would be up-in-arms and posting to high-heaven about it.

    Why does Dr. B get a pass? Why should he not have to follow the same guidelines and protocols that everyone else has to follow, especially in light of not publishing any results over the last 30 years?

    Seriously woo-heads – we know you are going to show up here, so how about not posting until you answer the following, simple, questions:

    1) Why hasn’t Dr. B published any clinical results?

    2) Are you aware that Dr. B, in the evidence uncovered above, admits to applying conventional treatments to his patients?

    3) Why does Dr. B force his patients to spend hundreds of thousands of dollars for clinical trials, when the “standard” clinical trial is normally FREE?

    How about it people? Why don’t you hold your idol to the same standard as everyone else?

  3. #3 Mrs Woo
    August 16, 2012

    Sadly, they will assure everyone that the COI demonstrated, etc., are all part of a conspiracy by “Big Pharma to close down an innocent and wonderful researcher who resists authority” rather than “there’s something not right there and these people might be much more interested in their own bottom line than patient interests.”

  4. #4 david
    August 16, 2012

    FDA wrote those letters over 10 years ago. What happened since?

  5. #5 Michael Wosnick
    August 16, 2012

    Shocking, yet not at all shocking at the same time.

  6. #6 palindrom
    August 16, 2012

    Good heavens.

    The list of things that the IRB has FAILED to do looks, to the untrained eye, pretty much like the list of things that an IRB would be REQUIRED to do.

    At my university, the sponsored research office seems to live in holy terror of “compliance issues”. I suppose Burzynski gets away with (almost literal) murder because he isn’t receiving Federal funds, but is instead simply bilking the desperate.

    It’s a good thing to be sure that all expenses are appropriate, but it’s something of a sad commentary that taxpayer money is looked after much more carefully than innocent patients.

  7. #7 Roger1234
    August 16, 2012

    Hey Orac – if you really want to “debunk” Burzynski’s ability to cure incurable cancer, not using a “natural substance” because you just made that part up – it’s a patented proprietary group of chemicals made in a laboratory, just like chemotherapy – perhaps you need to actually spend a few days at his clinic instead of writing this dribble and embarrassing the piss out of yourself. You will not do that, because you find it easier to hide behind your fake name “orac” and just make things up as you go along. Give it a rest. Your adoring readers are too stupid to research anything on their own. Based on the term’s definition, Orac is one of the biggest quacks out there.

  8. #8 Mu
    August 16, 2012

    What gets you in trouble with the feds is publishing falsified data. If you don’t publish, they can’t get to you…

  9. #9 Andreas Johansson
    August 16, 2012

    hemorrhagic cystitis, serious diarrhea, pancreatitis, central line sepsis, pneumonia, renal acidosis, and even death

    Whenever I see a list like that, I’m impressed that the writer resisted the temptation to refer to the last condition as “metabolic cessation” or the like.

    Anyway, disregarding whether “antineoplastons” actually work, about the only things distinguishing Burzynski from big bad Big Pharma seems to be sloppiness, grandiosity, and price. Now, obviously the 2nd will help attract some, but I’m wondering if we might also be seeing a variant on the phenomenon where people assume that if something is expensive it has to be good? Might the stupidly high price tags actually help attract patients?

  10. #10 Eric Lund
    August 16, 2012

    I had an “aha” moment while reading this post: Maybe the pharma shill gambit is little more than good old fashioned projection. Woo-pushers like Burzynski pull in big bucks pushing dubious treatments, so they assume that doctors like Orac do so as well.

    Of course one of the things an IRB is supposed to do is to prevent exactly that sort of thing. For that matter, I have done proposal reviews (for stuff that doesn’t involve human or other live animal subjects), and they always ask people to leave the room when somebody from that person’s institute is listed as a co-investigator on the proposal the panel is about to discuss. At least in my field, I cannot be on a proposal review panel if I am requesting funding in a proposal that panel is reviewing (at least one program officer has told me that this is the only way to guarantee that you are not on the panel). Having an IRB chairman who is both your co-investigator and a director of the institute bearing your name ought to be unthinkable–why hasn’t Dr. Hazelwood been asked to resign from at least one of those positions, and if he has been asked, why doesn’t the FDA have the teeth to back up the “or else” part of that?

  11. #11 Orac
    August 16, 2012

    @Roger1234

    It’s not me who just made up the claim that Burzynski is touting his therapy as “natural.” He does and his fans do. For instance, his therapy is referred to as “all-natural” and “non-toxic.”

    http://www.naturalnews.com/032998_Burzynski_cancer_cures.html

    Burzynski claims that antineoplastons are part of the body’s “natural biochemical defense system” in the body that whose power he is harvesting.

    http://www.burzynskiclinic.com/burzynski-clinic.html

    As for antineoplastons, I have been pointing out all along that they are chemotherapy and that all the B.S. about their being “natural,” “targeted,” and “non-toxic” is just that: pure B.S. I’m glad you understand that.

  12. #12 trrll
    August 16, 2012

    if you really want to “debunk” Burzynski’s ability to cure incurable cancer, not using a “natural substance” because you just made that part up – it’s a patented proprietary group of chemicals made in a laboratory, just like chemotherapy – perhaps you need to actually spend a few days at his clinic instead of writing this dribble and embarrassing the piss out of yourself. You will not do that, because you find it easier to hide behind your fake name “orac” and just make things up as you go along.

    Awwww….Isn’t it cute when a clueless defender of a quack shows up and accuses Orac of “hiding” behind his pseudonym–when in fact his real name is an open secret and virtually everything that appears in this blog is eventually published under his real name in another blog (albeit sometimes in a less amusingly insolent form).

  13. #13 thenewme
    August 16, 2012

    Despite all the evidence against him, somehow Burzynski has a large group of fans. For breast cancer specific examples, just go do community.breastcancer.org and do a search for his name there.

    Of course, most of his proponents there also happen to be the usual altie shills who “happen” to sell bogus supplements, treatments, wellness products and events, etc.

    Burzynski is despicable, and the only reason I can guess as to why he’s still practicing, is that he’s in Texas (proudly self-proclaimed anti-science state) and likely a big contributor to political activities.

  14. #14 Mike
    August 16, 2012

    *reads Roger’s post curiously*

    “Uncle Orac, is that one of those troll things I hear so much about? He’s funny. Like one of those monkeys at the zoo.”

  15. #15 THS
    cool, clear morning
    August 16, 2012

    Wow. I mean, like, wow. How do they do it?
    Odgen Nash line:
    So I took my mommy’s morals and I took my daddy’s crust

  16. #16 Marc Stephens Is Insane
    August 16, 2012

    Just a thought: Eric Merola, the producer of the Burzynski commercial, used the online name “Roger” last year to defend the doctor and his own movie. Could our Roger1234 be the very same Eric Clinton Merola?

  17. #17 Marc Stephens Is Insane
    Monrayal
    August 16, 2012

    Does anyone know when the postponed TMB hearings will take place? I remember seeing something here back in June
    –someone posted an update but I can’t seem to find that message thread right now.

  18. #18 Denice Walter
    August 16, 2012

    @ Eric Lund:

    re pharma shill as projection/ deflection

    You know, I survey alt med gurus and read about various ‘treatments’ ( courtesy AoA, TMR, web woo-meisters) and *often* am astounded to hear about UN-TESTED, HIGH DOSAGE vitamins, minerals, phyto-chemicals, herbs and industrial products ( and combinations thereof) being prescribed cavalierly as though they had NO deleterious effects.

    High dose vitamins are not side effect free; certain herbs like chaparral can be problematic; Ayurvedic and TCM herbal concoctions can be contaminated with metals and/ or include other substances that can be harmful. Yet I hear Null tell people to take products 5 times a day in combination with others; Adams champions a guy who sells black salve; Mercola warns about the *dangers* of SBM and simultaneously congratulates woo-meisters; parents of kids with ASDs write enthusiastically about using bleach ,chemical castration and lord knows what else…

    I understand that the younger Geier just got a slap on the wrist for impersonating a doctor:
    I wonder how many others we discuss here @ RI fit into exactly the same category because of their *counselling* activities and *nutritional advice*? Do you really think that AJW just gives lectures in Jamaica?

  19. #19 Marc Stephens Is Insane
    August 16, 2012

    Denice–not to derail this thread but do you think David Geier considers a $10,000 fine to be a slap on the wrist? Do they make so much money that this is only a minor speedbump for them? Will authorities now be scrutinizing his activities to make sure he doesn’t continue to impersonate a doctor?

  20. #20 Denice Walter
    August 16, 2012

    @ MSIS:

    *I* consider it to be a slap** on the wrist: I have no idea about their total earnings but they were/ are in many locations, I understand, and I haven’t a clue about how he’ll be monitored, if at all. His father is also still to be considered. Let’s not forget, these people are slippery- if there’s a way to continue making money, I’m sure they’ll find it.

    ** as opposed to a SLAPP.

  21. #21 Calli Arcale
    August 16, 2012

    Denice — ayurvedic concoctions aren’t just contaminated with metals; lead is the active ingredient intentionally put into some remedies. The mind boggles.

  22. #22 Narad
    August 16, 2012

    Does anyone know when the postponed TMB hearings will take place? I remember seeing something here back in June

    There was a hearing on June 27 over the Board’s motion to reconsider Order No. 12. There’s nothing currently on the SOAH docket for 503-11-1669.MD.

  23. #23 Marc Stephens Is Insane
    Monrayal
    August 16, 2012

    Narad:

    Thanks for the update, but what does that mean? What was discussed at the June hearing, i.e. what’s Order 12 and why would it need to be reconsidered?

  24. #24 Narad
    August 16, 2012

    i.e. what’s Order 12 and why would it need to be reconsidered?

    It dismissed the portion of the Board’s complaint predicated on Burzynski’s vicarious liability for the actions of his staff and dealt with a few evidentiary matters. They want to preserve the vicarious liability and exclude from Burzynski’s defense investigative material that he obtained as part of an earlier voluntary, informal proceeding.

  25. #25 elburto
    August 16, 2012

    But Calli, lead is. so sweet and yummy! It’s also all ~*natural*~, therefore it must be good for you.

    Roger, where have you gone? Come back and play with us tell us more about Stan’s Magic Micturitional Medicine.

  26. #26 Narad
    August 16, 2012

    In other regulatory news, courtesy AoA, hopelessly inept antivax lawyer Patricia Finn is suing the State Grievance Committee for the 9th District under the Civil Rights Act. My PACER account has lapsed and I’m feeling lazy, but if anyone wants to go looking, it’s case 7:2012cv05742.

  27. #27 Mojo
    August 16, 2012

    @Lawrence

    If information like this came out regarding a normal “Pharma” company, you can guarantee that the woo-meisters would be up-in-arms and posting to high-heaven about it.

    See also German Homeopathy Companies Pay Journalist who Smears UK Academic.

  28. #28 Daniel J. Andrews
    August 16, 2012

    Slight O/T, but maybe relevant. Skeptic organization, The 21st Floor has their site censored by the university for “hate and discrimination”. Except they don’t have hate speech, but recently have written critically of Scientology and Burzynski.

    They’re waiting to hear why they were censored.
    http://www.thetwentyfirstfloor.com/?p=4766

    hat tip: Simon Singh on Twitter

  29. #29 Narad
    August 16, 2012

    OK, my curiosity got the better of me: Patricia Finn’s complaint. I’m only skimming it, but paragraph 24 made me feel like I had just taken a ride on a log flume floating in crazy juice.

  30. #30 Mu
    August 16, 2012

    Sounds like a nasty divorce flowing over in her general law practice. As loony as she is, if her ex is really sleeping with the head of the regulatory commission, someone should have recused herself.

  31. #31 Narad
    August 16, 2012

    Paragraph 98 also appears to be a knowing exaggeration taken straight out of her self-promotional material (I’m not sure what it’s there for in the first place):

    98. On February 8, 2012 Plaintiff appeared on a radio show for NPR where she was interviewed about two federal cases she is handling on behalf of children who were excluded from school because they were not vaccinated.

    The actual reference is to this. Judging by the more recent entries that have audio, the whole thing was a ~5 minute news drop-in on WNYC. This is not “a radio show for NPR.”

    Her own FB post of February 8 indicates that she knows the difference:

    Fred Mogul of NPR affiliate WNYC interviewed Patti regarding lawsuits brought against the school district by parents who do not want their children vaccinated.

    This thing is really odd. Not only does she constantly capitalize sua sponte, she uses the construction “Sua Sponte Advertizing” at least twice.

  32. #32 Narad
    August 16, 2012

    As loony as she is, if her ex is really sleeping with the head of the regulatory commission, someone should have recused herself.

    This is true, but I haven’t actually seen it asserted yet. The “inappropriate relationship” seems to have been simple communication and alleged weird texting from the husband.

  33. #33 BKsea
    August 16, 2012

    Orac, I wonder if you are reading too much into a phase III trial listed on Clinicaltrials.gov. I manage trials for a (device) company I am involved with, including creating and maintaining entries on clinicaltrials.gov. As far as I know, I could enter anything I want there.

    I read the situation as Burzynski decided to try to proceed with a phase III trial and created an entry for it at Clinicaltrials.gov. Now, he is waiting for an NDE from the FDA to proceed (which he may never get). Is there any additional information to suggest this is incorrect?

  34. #34 Agrippina
    August 16, 2012

    BRI IRB is a nonprofit entity so (some) information is available in their IRS forms 990.
    FY 2008: http://tfcny.fdncenter.org/990_pdf_archive/200/200783537/200783537_200812_990.pdf

    FY 2007: http://tfcny.fdncenter.org/990_pdf_archive/200/200783537/200783537_200712_990.pdf

    FY 2006: http://tfcny.fdncenter.org/990_pdf_archive/200/200783537/200783537_200612_990.pdf

    FY 2005: http://tfcny.fdncenter.org/990_pdf_archive/200/200783537/200783537_200512_990.pdf

    FY 2004: http://tfcny.fdncenter.org/990_pdf_archive/200/200783537/200783537_200412_990.pdf

    Although the forms are clearly identified as BRI IRB, in the Foundation Center’s 990 database, they are indexed as “Bristol” Institutional Review Board.

    I believe this FDA proposal to debar to Dr Arthur Ericsson is related to the objectionable findings in the BRI IRB inspection: http://www.circare.org/fdawls3/ericsson_20080331.pdf
    More of same: http://www.circare.org/fdawls3/ericsson_20090304.pdf

    Earlier warning letter regarding possible misbranding of dietary supplements: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2006/ucm075778.htm

    Phase 3 trial for diffuse intrinsic pontine glioma: this 2009 press release announced the BRI contracted with CRO Premier Research to conduct a trial in subjects newly diagnosed with DIPG:
    http://www.burzynskiresearch.com/assets/PressRelease_01262009_BZYR.pdf

    It’s 21/2 years later and I’ve yet to see any indication the trial is open for recruitment.

  35. #35 ChrisP
    August 16, 2012

    The supporters of Burzynski et al. turn a convenient blind eye to his lack of process, something they would flay pharmaceutical companies over. This is because the whole exercise is not about Burzynski’s practices, but about the fact that he is against the establishment of the FDA and modern medicine.

    Burzynski has been co-opted because his fight against the FDA appeals to the natural order of the world as seen by alternative medicine defenders. Any corruption or illegality is simply air-brushed aside as a conspiracy to shut them up by Big Pharma. As will the upcoming court action. Burzynski et al. cynically exploit this thinking in order to make money.

    I am often in awe of how many contradictory ideas alt med defenders can keep in their heads at the same time without the ideas meeting and spontaneously imploding.

  36. #36 Marc Stephens Is Insane
    August 16, 2012

    ChrisP,

    You mean people like like Timmy Bolen, who spent years working for Hulda Clark, selling her “liver flukes cause cancer” theories to the world. Then, right after she died, Bolen stared shilling for Burzynski. If Clark was right, then Burzynski is wrong. I always wondered how he reconciled that in his little mind.

    The alt world semingly will support anyone working from outside the system, even when everything is contradictory. The same people support Gerson AND Burzynski AND Simoncini AND Robert O. Young. They can’t all be right.

  37. #37 Denice Walter
    August 16, 2012

    OT: but quackery and woo DO seem to thrive in Texas…

    AoA’s editor ( I’m assuming Dan, since they have 3) shrieks today about the scheduled pesticide spraying of Dallas to combat the West Nile virus problem: he notes that children developing neurological conditions should be in their future.
    Commenters carry on as per usual.

  38. #38 Spectator
    August 16, 2012

    Burzynski needs to brand his racket as the

    “Creation Anti-Cancer Cure”, using “God, not Evolution ‘Science’ to Cure Cancer”, and declare the investigation to be tool of “evolutionists, university professors and jews”.

    Thus ends any issues with the Texas board. Simples.

  39. #39 Narad
    August 16, 2012

    I must apologize for my fascination with this Finn complaint.

    Plaintiff and her lawyer had not seen the findings before, and quickly reviewed them before entering the committee meeting room to receive the discipline.

    And I don’t even care for King Crimson.

  40. #40 Krubozumo Nyankoye
    August 17, 2012

    I’ll go out on a limb here because I am in a particularly cynical state of mind. Everyt con in the world operates on the principle of something for nothing. A few people manage to pull it off, Romney, the Koch brotheres, Adelsone and many others. They might as well have printing presses to churn out Federal Reserve Certificates.

    And saddly, perversely, that is a prime criterion for success. As a mass collective, we tend to accept the ridiculous idea that being rich is an accomplishment.

    Thus frauds such as this one, can thrive at the expense of the doomed, and the many who sympathize with the doomed.

    Medicine is of course a ripe discipline for this kind of fraud because it is so important. It is literally a matter of life and death.

    What I find odd and inexplicable is that millions, litterally are incarcerated for using or selling an innocent weed, while perverted nostrums such as this clinic’s witches brew go on and on with the gravest threat they face being to be shut down, only ot reincarnate under a different veil.

    Back in the day we had an expression that described this kind of situation pretty clearly, it was FUBAR.

    From the rain forest, where nothing really matters.

  41. #41 Pareidolius
    The Edge of Night
    August 17, 2012

    I’m watching my own neice become an altie zealot in the making. One of her dear friend’s husband is just 40 years old. They have several children and are facing his death from pancreatic cancer. He has opted for Burzynski. My neice claims that Kaiser told him that he had months to live and “will have nothing to do with him now.” It’s all the evil FDA and Monsanto and I’m waiting for Hitler to show up soon. She’s so anguished over his illness (understandable) and she’s lashing out because it isn’t fair and someone must be to blame. I don’t dare say anything at this point, but her constant pushing of Burzynski and Gerson (and their respective infomercial/movies) as heroes on Facebook is galling and I don’t really know how to broach the subject without being cut off. I think time is the only thing that will allow for her to hear anything negative about these charlatans. I’m just biting my lip for now.

  42. #42 Kathryn
    Valley of the Heart's Delight
    August 17, 2012

    I don’t recall what type of cancer a good friend’s late husband had, but they felt his Kaiser physicians treated it as well as possible and gave them no temptation to fall prey to alternative treatments.

  43. #43 Paul Morgan (@drpaulmorgan)
    United Kingdom
    August 17, 2012

    Hazlewood is indeed an “interesting” character. His links to Burzynski may be more complicated than it appears on the surface. I’ve blogged on a few things that I’ve found out http://drpaulmorgan.posterous.com/carlton-hazlewood-the-burzynski-research-inst
    Maybe someone in the US can find out more.

  44. #44 Lawrence
    August 17, 2012

    It both sickens and angers me that Dr. B is able to use the millions he’s made in bilking Cancer patients to prolong the legal process so he can continue bilking additional millions from new Cancer patients…..a sick cycle if there ever was one.

  45. #45 elburto
    August 17, 2012

    Marc Stephens is Insane – re. the alternuts and their contradictory loyalties:

    The enemy of Teh Big Pharmas!!!11 my enemy is my friend.</center

  46. #46 elburto
    August 17, 2012

    Apologies for messed up formatting. My autocomplete changed it!

  47. #47 Old Rockin' Dave
    August 17, 2012

    During the time in the 1980s when I worked at Mount Sinai Hospital in New York, a thoracic surgeon did a heart transplant; Sinai was not a state-approved heart transplant center. New York State shut down *every* activity at the hospital related to transplantation, related or not: kidney transplants, bone marrow transplants, transplanting the African violets on office windowsills (Well, not really – I made that last one up). Given that the FDA and state health departments and regents draw from the same pool of people, it is shocking to me that decisive action has not been taken against Burzynski. Maybe someone should look into his political connections and donations. It wouldn’t be the first time that medical policymakers have been shut down by “higher authority”.

  48. #48 Old Rockin' Dave
    August 17, 2012

    A few minutes after posting here, I came across this:
    http://www.smbc-comics.com/index.php?db=comics&id=2706#comic

  49. #49 Marc Stephens Is Insane
    August 17, 2012

    Dave,

    This is from Josephine Jones’s blog:

    Political contributions

    Dr Stanislaw Burzynski and his wife Barbara Burzynski (who is also Director of the Burzynski Research Institute) have both made interesting political contributions.

    According to the Texas Tribune Campaign Finance Data (source: Texas Ethics Committee), between November 2000 and December 2011, Stanislaw Burzynski made 27 donations ranging from $50 to $300 to Texpac (Texas Medical Association Political Action Committee.

    In September and October 2010, he also made contributions of $1000 and $5000 to Texas Governor Rick Perry’s campaign.

    But the most surprising figure is the $50,000 donated by Barbara Burzynski to the Conservative Republicans of Texas. Unsurprisingly, ‘Conservative Republicans’ believe in free-market solutions to health care and in cutting government spending and regulation.

    Incidentally, Conservative Republicans also campaign against abortion – or as they call it, for the ‘sanctity of human life’ (while supporting capital punishment and the right to own guns). They also don’t believe that homosexuality should (in their words) be taught as an ‘acceptable alternative lifestyle’.

  50. #50 Phoenix Woman
    August 17, 2012

    Mrac @ 12:30 — good catch! That explains a lot.

  51. #51 Old Rockin' Dave
    August 17, 2012

    Marc,
    thanks, I knew someone would come up with something. It’s very suggestive, but not quite the smoking gun that I suspect is lying out there waiting to be discovered.

  52. #52 herr doktor bimler
    August 17, 2012

    re. the alternuts and their contradictory loyalties:
    It comes down to ‘professional courtesy’, as they said when the sharks wouldn’t eat the lawyer.

  53. #53 flip
    August 18, 2012

    It’s obvious why Burzyinski continues doing the same thing, despite the warnings. The FDA never actually does anything after repeated warnings. So B. continues, knowing full well the FDA won’t bother following up.

    On a completely off-topic … topic…

    I would love it if Orac would write a bit about something I’ve recently discovered. There’s an awful lot of people who post wanted ads for writers for “self help”/woo-based guides out there on the net. It seems everyone who’s ever experienced any illness wants to have their personal experience ghost-written and marketed. Not to mention those who have set up their own “wellness” clinics.

    Seems as though these people have trouble explaining their own ideas and are expecting freelance writers to take up the job. Unsurprisingly a lot of people apply for these jobs…

    Now I know I have no right to request such things… but consider this a friendly nudge anyway ;)

  54. #54 DanielR
    Los Angeles, CA USA
    August 19, 2012

    I stumbled upon this blog accidentally and then read about Dr. Burzynski. The author of this blog sounds rather vindictive, caustic, venomous, and resembles petty gossip column style (yet less skilled). It reads like the here say blabber one hears from the televangelist Pat Robertson or the theatrics of an Ann Colter. Any relation?

    Why would there be condemnation of a cancer treatment alternative? Even if it was highly toxic, had major side effects, damaged you liver, heart and lungs, caused patients to lose their hair, caused nausea and vomiting, and then death, wouldn’t that be equivalent to standard therapies?

    Could someone explain this to me like I was a 6 yr old?

  55. #55 Gray Falcon
    August 20, 2012

    Could someone explain this to me like I was a 6 yr old?

    It doesn’t work.

  56. #56 JGC
    August 20, 2012

    Even if it was highly toxic, had major side effects, damaged you liver, heart and lungs, caused patients to lose their hair, caused nausea and vomiting, and then death, wouldn’t that be equivalent to standard therapies?

    If it were equivalent to standard therapies Burzinsky would be able to idnetify the mechanism by which antineoplastins act, actual evidence that they are efficacious, would have completed pre-clinical and clinical trials assessingindentifying maximum tolerated dosage, their safety and toxicity profiles, full ADME characterization, and demonstrated efficacy , etc.

    And finally he wouldn’t have charged a single subject a dime to participate in any of his clincal trials.

    There is no evidence that antineoplastins work, For that matter there’s actually no evidence that he’s conducting clinical trials with the intent of proving they work, rather than simply as a way to get around legal obstacles which would otherwise prevent him from continuing to charge patients exorbitant fees for treatment at his clinic.

  57. #57 Marc Stephens Is Insane
    August 21, 2012

    It doesn’t take long for the quacks to appear in order to exploit a celebrity death and drum up business, and here’s another example.

    There was a rumour (since denied by the family) that film director Tony Scott had terminal brain cancer and that’s why he killed himself. Peter Bowditch at ratbags.com has posted some tweets from a Burzynski supporter claiming Dr. B. could have cured Scott and imploring people to spread the word about Stan.

  58. […] at my fast and furious, whether it be the dubious testimonial I discussed yesterday, yet another deconstruction of the moral bankruptcy that is Stanislaw Burzynski, or my take on the sheer quackery that is “naturopathic oncology.” The first rule of […]

  59. […] wait. I’m not talking about Stanislaw Burzynski this time. But we do still have a problem, and it’s a problem that resembles the Burzynski […]

  60. #60 EatatJoes
    August 23, 2012

    His film(s?) are very persuasive to those who are already wary of chemotherapy/Big Pharma/etc. I know of someone who is at one of his clinics. I do not know how that person is doing but I’m wondering how much money was paid to get that person there.

  61. #61 DLC
    August 23, 2012

    And still, Burzinksy refuses to publish. Why ? because he can flog his quackery for outlandish sums to poor desperate people right up until his urine extract is proven to be piss. Anybody else think this behavior is despicable ?

  62. #62 Joel Shapiro
    United States
    August 29, 2012

    There are so many aspects to this continuing Burzynski saga with each in its own right begging to be addressed first e.g. how the FDA has give Dr. Burzynski the clearance to conduct Phase III trials when the FDA formally contends Antineoplastins have not been shown to prevent or treat any illness or malady in general or cancer in particular.

    This is a prerequisite for Phase III trials. How is it that Dr. Burzynski was given Phase III trial clearance by the FDA? If this is not enough in its own right how is it that the FDA permits continued Phase III drug trial clearance in light that Dr. Burzynski or to be technically correct Burzynski’s IRB has not adequately addressed the terms, conditions and criteria of a stern warning issued by the FDA (specifically Dr. Kevin Prohaska)?

    I’ve meticulously documented all of this throughout Orac’s Respectful Insolence scienceblogs and I’ll be soon making a web page devoted documenting this in explicit detail.

    In an unfortunate but best figurative analogy I can come up with; if you consider Dr. Bruzynski a cancer overtaking precious dollars that could be used for cancer research and treatments in the pipeline that show far greater real promise albeit less than advertised fake snake-oil promise of Dr. Bruzynski’s urine based antineoplastons as much as I abhor Dr. Bruzynski milking the system I really don’t blame him at all, I blame the system which allows him and his descendants to live long and prosper. The system in this case is the FDA and the Texas Medical Board.

    Say you’re a rat or a cockroach (I’m sure you’re not but for argument’s say you are) and say you’ve found yourself a hoarder like one of those on the cable show. Wonderful wonderful boxes of half eaten pizzas and frozen dinners. Once you’ve established yourself in your particular good situation do I blame you for taking advantage of all aspects; in this case some hoarder providing you the possible best case scenario of preferred digs and food sources?

    Of course not!

    Probably if you were a rat or cockroach I figured you’d have their mindset and if “intelligently discussed or pleaded” with you to take yourself elsewhere and your health threat to the community you’d do so on your own volition? (!)

    HA! Again, of course not!

    I can you and see the rats and cockroaches from all quarters will come back saying they’re really not such bad guys after all. Y’all might might contend they’re part of the nature cycle and all their disease threat claims like the plague for one are really overblown.

    So I pull out, post, regurgitate all the rat and cockroach disease vector studies, stats and data that point by point show you really are what you are: a menace to society.to anybody who’ll listen,

    That’s an important thing indeed in of itself to do but in of itself it’s really a dead end. You may claim you’re offended, threaten to sue me for defamation of character and it may reach someone looking to live next door but as far you’re concerned life’s good!

    No what’s needed as the “cure for you” is to prod the system to take action: in this case your public health department for letting you and your hoarder maintain status quo.

    As you really are the health threat you think you aren’t what’s really needed is to prod, pursue, protest, out on a continuing basis to the ends of the earth the system that permits you to continue to be; to exist.

    In your case it’s the public health department. They (should) know more than anybody the threat you pose to society and likewise the FDA of Dr. Bruzynski and his antineoplastons.

    In your case it is the COMBINATION of your presence and the inaction of the public health that is overall threat to society. But as disgusting as you the rat or cockroach is for being a public health threat I really don’t blame you for your existence. I REALLY blame the public health department for allowing your and your hordes of brethren to continue to exist where the threats you pose compound by the day.

    The same thing thing in all context with respect to the Dr, Bruzynski and the FDA and the Texas Medical Board.

    Joel S.

  63. […] Stanislaw Burzynski versus regulations protecting human research subjects [Respectful Insolence] (scienceblogs.com) […]

  64. […] Burzynski for peddling an unproven cancer cure, charging his patients for taking part in his clinical trials, and his “personalized medicine for dummies” approach to targeted […]

  65. […] Stanislaw Burzynski versus regulations protecting human research subjects Orac, Respectful Insolence, 16/08/12 […]

  66. […] 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 […]

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