Respectful Insolence

Here we go again.

Every time I think I can get away from this topic for a while, I get sucked back in. Indeed, it seems that hardly a week can go by when I don’t find myself pulled inexorably back to this horrible, horrible clinic and what I consider to be the abuses of science and clinical trials that go on there on a daily basis. Whether it be the patients who are offered false hope at the cost of tens or hundreds of thousands of dollars in the form of a chemotherapeutic drug known as antineoplastons that, contrary to what it is claimed, is not “non-toxic,” “natural,” or even particularly well-targeted gene-targeted cancer therapy, or other incompetence, the Burzynski Clinic is drawing me back below its event horizon again, like the irresistable black hole made up of supercompressed greed that I see it to be. If there was ever a target for skepticism and critical thinking where the consequences of letting a “brave maverick doctor” run roughshod over human subjects protections. How he has continued to get away with it for over 30 years is one of the great questions in drug regulation. Somehow, he does, year after year.

A while back, I discussed in depth what I referred to as Stanislaw Burzynski versus regulations protecting human subjects. Sadly, up until recently, when it came to a battle versus human subjects protections and Burzynski, Burzynski almost always won. Who knows? he might even win his latest kerfuffle with the FDA, which was recently on site at the Burzynski Clinic, resulting in an at least temporary shut down of antineoplaston usage and advertising. However, as Elton John’s song goes, I’ve seen that movie, too, and I have little faith that the FDA will do anything. Thirty years of impotence in the face of what Burzynski does will do that for me. On the other hand, Bob Blaskiewicz has obtained, through the Freedom of Information Act, the FDA Form 483 from at least part of the recent FDA visit to the Burzynski Clinic. It’s the most recently dated FDA report I’ve ever seen (dated February 7, 2013) and consists of the observational notes from the inspection that took place from January 22 to February 7, 2013. Given that it was apparently mentioned by attendees at the screening of the second installment of Eric Merola’s apparently never-ending hagiography of the Great Man on March 9 that the FDA was still at the Burzynski Clinic then, these notes can only be viewed as preliminary, but they are telling. They deal mainly with the Institutional Review Board (IRB) that oversees Burzynski’s clinical trials.

I’ve discussed the problems with Burzynski’s IRB before, and these notes simply amplify and add detail to the problems that were already known. These notes suggest how Burzynski uses his IRB to get around some of the restrictions that were placed on him using antineoplastons. As you might recall, the Common Rule demands that all clinical trials by investigators whose institutions receive federal funding or that are being done in order to win FDA approval for a drug or device must be overseen by an IRB, whose purpose is to protect the human subjects who take place in the trials. This is an absolutely essential purpose of the IRB, its key reason for existence. It is not there to evaluate the science, except to the extent that badly designed clinical trials based on bad science endanger human subjects. Its purpose is to make sure that the risks and benefits of clinical trials are reasonably balanced, make sure that patients entering clinical trials receive adequate informed consent, and to keep an eye on the trial as it is being carried out, evaluating adverse event reports and, if necessary, shutting the trial down if there are too many or if one group starts doing too poorly relative to the other.

First, let’s recap what has been known about Burzynski’s IRB. First, we know that the IRB is headed by Carlton F. Hazlewood, PhD, who just so happens to be on the board of directors of the Burzynski Research Institute. As I noted before, given that the Burzynski Clinic is trying to commercialize antineoplastons, this is a profound conflict of interest. I also ask you to think of it this way again: 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 oversees Merck’s clinical trials? This is the same thing. True, it’s not quite as bad as having the principal investigator of a study chair the IRB overseeing his studies, as Mark Geier has done, but it’s pretty bad. This should not be done. Again, one wonders how Eric Merola, for instance, would react if pharmaceutical companies or even research institutes trying to commercialize a discovery made by their investigators could allow high ranking leadership sit on their IRBs. Apparently, however, to propagandists and apologists like Eric Merola, when Burzynski does it, it’s just ducky.

Before we move on to the new notes, lets look at the things the FDA dinged Burzynski for over the last ten years:

  • 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.
  • 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.
  • 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.

Reading the Form FDA 483 notes from the FDA’s latest visit is like a bad acid flashback of the letters sent to Burzynski over the last decade or so. Included in the notes are observations that:

  • “The IRB [Institutional Review Board] used an expedited review procedure for research which did not appear in an FDA list of categories eligible for expedited review, and which had not previously been approved by the IRB. Specifically, your IRB routinely provided expedited approvals for new subjects to enroll under Single Patient Protocols.”
  • “The IRB approved the conduct of research, but did not determine that the risks to subjects were reasonable in relation to the anticipated benefits (if any) to subjects, and to the importance of the knowledge that might be expected to result. Specifically, your IRB gave Expedited Approval for several Single Patient Protocols (SPP) without all the information necessary to determine that the risk to subjects are minimized.”
  • “The IRB did not determine at the time of initial review that a study was in compliance with 21 CFR Part 50 Subpart D, ‘Additional Safeguards for Children in Clinical Investigations.’ Specifically, an IRB that reviews and approves research involving children is required to make a finding that the study is in compliance with 21 CFR Part 50 Subpart D, ‘Additional Safeguards for Children in Clinical Investigations.’ Your IRB approved research involving children without documentation of the IRBs finding that the clinical investigation satisfied the criteria under Subpart D.”
  • “The IRB did not follow its written procedure for conducting its initial review of research. Specifically, the IRB is required to follow its written procedures for conducting initial and continuing review. Your IRB did not follow your written procedures for conducting initial and continuing review because these subjects received IRB approval via an expedited review procedure not described in your Standard Operating Procedures. If your IRB would have followed your own SOP for initial and continuing review, the following subjects would have received review and approval from the full board rather than an expedited review.” [2 adults and 3 pediatric patients are listed.]
  • “The IRB has no written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any unanticipated problems involving risks to human subjects or others. Specifically, your current SOP-2012 v2-draft doc does not describe the requirements on Investigators on how unanticipated problems are reported to the IRB, Institutional Official, and the FDA, such as time intervals and the mode of reporting, or otherwise address how the prompt reporting of such instances will be ensured.”
  • “The IRB has no written procedures [in the SOP-2012 v2-draft doc] for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any instance of serious or continuing noncompliance with theses [sic] regulations or the requirements or determinations of the IRB.”
  • “A list of IRB members has not been prepared and maintained, identifying members by name, earned degrees, representative capacity, and any employment or other relationship between each member and the institution.”

I mean, seriously. How long and how often can Burzynski get away with this sort of crap? The same deficiencies keep popping up again and again. Burzynski then assures the FDA, that, really and truly, this time the Burzynski Clinic will play nice and obey the regulations governing human subjects research. Lather, rinse, and repeat.

One violation in particular deserves a bit more discussion, as I’ve covered most of the others before in my previous posts on Dr. Burzynski versus the FDA. Burzynski’s apparent belief that the rules governing IRBs and overseeing clinical trials don’t apply to him because he is curing cancer seems to know no bounds.

In any case, I’m referring to Burzynski’s apparent abuse of the expedited approval process through his IRB. Quite reasonably, the Department of Health and Human Services through its= Office of Human Research Protections (OHRP) which oversees IRBs, do not require the same sort of approval process for every sort of human subjects research. For instance, in the case of human subjects research that involves pre-existing samples that have been de-identified can be exempted from full IRB review and oversight because, well, there are no human subjects to be endangered, even through linking of their identities to a specimen demonstrating a disease. Lots of research gets done this way, for example analyzing or staining pre-existing samples looking for a biomarker or a change in expression of a protein. I’ve done projects like this. This is Exemption 4, and there are several other exempt categories.

However, Burzynski doesn’t abuse the exemption process, which, let’s face it, would be very hard to abuse for the most part. What he appears to be abusing is the expedited approval process. The expedited review process generally involves approving things like minor revisions to research protocols and informed consent forms. “Expedited” generally means just that: Expedited. A full IRB review is not done, and a streamlined, faster process is used. Expedited approval can also be used for protocols that fall under categories that the HHS deems to be “minimal risk,” described thusly on the University of Kentucky website:

Expedited procedures can only be used to review a study if the only involvement of human subjects fits one or more of the categories specified in the federal regulations and if all of the procedures present no greater than “minimal risk.”

The IRB reviewer confirms that all of the research activities fit in one or more of the expedited categories. If the research includes activities that do not fit in the categories, the study is not eligible for expedited review even if the research involves “minimal risk.”

The Department of Health and Human Services defines minimal risk to mean “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” [45 CFR 46.102(2)(i)].

Investigators are asked to provide a risk assessment, but it is the IRB reviewer’s responsibility to determine whether the research meets the federal definition.

The IRB reviewer must consider two questions:

  • Is the probability of the harm or discomfort anticipated in the proposed research greater than that encountered ordinarily in daily life or during the performance of routine physical or psychological examinations or tests?
  • Is the magnitude of the harm or discomfort greater than that encountered ordinarily in the daily life or during the performance of routine physical or psychological examinations or tests?

If the answer is “yes” to either of these questions, then the research does not meet the definition of minimal risk.

A list of the types of research that can be approved through expedited review can be found on the OHRP website. These include things like blood draws, prospective collection of biological specimens by noninvasive means (one could collect urine specimens, for instance, under a protocol approved through the expedited review process), and research involving data that has already been collected. Here’s a hint: Approving “single patient protocols” for an investigational drug that is not FDA-approved does not fall into any of the categories for which expedited review is appropriate, particularly when so many of the patients involved are children and particularly when the drug being tested can cause severe hypernatremia. Basically, from my reading, Burzynski seems to be using the expedited review process to treat patients with antineoplastons who do not qualify for any of his numerous phase II trials, and he seems to have been getting away with it.

As a translational researcher who frequently works with clinical investigators, I just can’t figure out how Burzynski keeps getting away with it. Either the FDA is more impotent than I had thought, or he has some serious pull with some powerful people. If my university received even one report like this, it would be quite possible that all federal research funding to the university for biomedical research would be suspended until the university fixed the problems to the satisfaction of the federal government. Yet the FDA has found Burzynski to be deficient in numerous areas of human subjects protection not once but at least twice over the last decade and appears to be poised to find it to be deficient in many of the same areas yet again.

If there’s one thing I’ve learned over the years about Brave Maverick Doctors, it’s that they often come to believe that the rules don’t apply to them. They crave the respectability of science, of course, but they are too impatient or too arrogant to play by the rules of science. Unfortunately, that often includes the rules designed to protect human subjects in clinical trials. We’ve seen it before with Mark and David Geier, who formed their own IRB stacked with their cronies. We’ve now seen it with Stanislaw Burzynski, who formed his own IRB. In the world of these Brave Maverick Doctors, the IRB apparently exists not to protect human subjects, but is instead viewed as a formality to funnel patients into whatever they want to do to treat them.

In my recent post in which I discussed Burzynski: Cancer Is A Serious Business, Part 2 (or, as I like to call it: Burzynski II: Electric Boogaloo or Burzynski II: This Time It’s Peer-reviewed), I told you five things I learned from the movie, all of which was pretty much pure nonsense turned into a massive infomercial for the Burzynski Clinic. There was one thing, however, I didn’t tell you, and now seems like a perfect time to tell you.

According to our moles who attended the movie, in the Q&A session after the movie, there was considerable—shall we say?—venting (well, ranting, actually) at the FDA and the federal government, which were described in terms of “health tyranny” and religious dogma in which antineoplastons were represented as being a safe “natural” alternative to chemotherapy, radiation, and surgery that is “totally nontoxic.” Of course, as I’ve pointed out many times before, this is massively stupid, given that antineoplastons are chemotherapy. In the midst of this, apparently an audience member asked Mini-B (my name for Greg Burzynski, Stanislaw Burzynski’s son and heir apparent to the Burzynski cancer empire) said that they had thought about it and that “everyone has an opinion.” It was also revealed that Burzynski is working with other countries to make this a possibility and that some doctors in China is apparently interested in bringing antineoplastons to China. This also led to the obvious revelation that Merola has a seriously inflated view of Burzynski’s importance and the importance of the “health freedom” movement supporting him, which was represented as being bigger than Gandhi, Martin Luther King, and the Occupy Movement.

I’d like to conclude by making a prediction. I could be wrong, but if the FDA is not impotent this time (a big “if,” I admit), I could easily see Burzynski moving to San Diego, the better to open a branch of the Burzynski Clinic in Tijuana to take advantage of Mexico’s less—shall we say?—rigorous laws and human subjects protections. I could then see him using the Houston branch for his “personalized gene-targeted cancer therapy” (for dummies), which is easier to do in the U.S. because he can use his antineoplaston prodrug (as he calls it) sodium phenylbutyrate off-label, as he does now, and add it to his “everything but the kitchen sink” cocktail of targeted therapies based on simplistic interpretations of a commercial test, as he also does now. Meanwhile, in Tijuana, he could shed any pretense of trying to prove that his antineoplastons work against advanced cancer any better than conventional therapy, and just sell, sell, sell. In fact, I wonder why he hasn’t done this before. Maybe he really loves Houston.

In that case, I guess he could always dispatch Mini-B to San Diego.

Comments

  1. #1 LW
    March 26, 2013

    ” If my university received even one report like this, it would be quite possible that all federal research funding to the university for biomedical research would be suspended until the university fixed the problems to the satisfaction of the federal government. ”

    Maybe that’s why Burzynski keeps getting away with it. They can’t cut off research funding because he doesn’t receive any; he just parasitizes desperate, dying patients and their families.

  2. #2 Dangerous Bacon
    March 26, 2013

    You know, if this keeps up, Burzynski might have to face the ultimate penalty – a really really firm warning letter from the FDA.

  3. #3 elburto
    March 26, 2013

    I am shocked I tell you, shocked to find out that Count Stan isn’t playing by the rules.

    +1 to LW for pointing out that he has an untapped source of money; the hopes and fears of dying people, and the goodwill of those who want to help them.

  4. […] Stanislaw Burzynski versus regulations protecting human research subjects, revisited Orac, Respectful Insolence, 26/03/13 […]

  5. #5 Mu
    March 26, 2013

    The problem is – what mechanism does the FDA have to get to him? He’s not getting federal funds, so they can’t disbar him from further contracting. He’s not violating standard of care as most of his patients are beyond standard care (and after the close shave he just had with the Texas medical board he’s probably going to be extra careful on his record keeping).
    So, unless there’s a “past performance” clause in clinical trial approval that allows the FDA to turn down new trails because the old ones were shoddy I don’t see what rule the FDA can apply to get rid of him.

  6. #6 Bronze Dog
    March 26, 2013

    The FDA could really use some teeth.

  7. #7 Todd W.
    http://www.harpocratesspeaks.com
    March 26, 2013

    @Mu

    Well, here are the acts prohibited by the FD&C Act, over which FDA has jurisdiction. And here are the possible penalties.

    There are a number of possible combinations of fines and/or imprisonment available to them, as well as placing temporary or permanent bans on him conducting human subjects research subject to the Common Rule. Of course, there are a number of ways for people to get around that last one, like setting up a new entity under a new name and carrying on as before.

    Most of what FDA can do really amounts to a slap on the wrist, though. The fines are relatively small. Jail sentences are short.

  8. #8 Mu
    March 26, 2013

    Todd, those are criminal penalties, which are really hard to make stick. And none of them authorize the FDA to deny further medical trials.

  9. #9 Eric Lund
    March 26, 2013

    This also led to the obvious revelation that Merola has a seriously inflated view of Burzynski’s importance and the importance of the “health freedom” movement supporting him, which was represented as being bigger than Gandhi, Martin Luther King, and the Occupy Movement.

    A variation on the Galileo Gambit. They laughed at Gandhi. They laughed at MLK. They laughed at Bozo the clown.

    As for moving to San Diego, the primary advantage would be to be within feasible daily commute distance of Tijuana. But if Dr. B really likes living in Houston and doesn’t mind driving a bit, there are several other border towns where he could open a branch, from Matamoros to Nuevo Laredo. He could spend one or two days a week at his clinic in that part of Mexico, then drive home and spend the rest of the week in Houston. One advantage of Houston: Real estate is much cheaper. He’d have to shell out some big bucks to get a house in San Diego that is anywhere near comparable to his Houston house.

  10. #10 Todd W.
    http://www.harpocratesspeaks.com
    March 26, 2013

    @Mu

    True, those were for criminal offenses. I should have included the following non-criminal enforcement options:

    There are also administrative actions they can take against the IRB, including halting current trials and withholding approval of future studies. They can also disqualify the IRB.

    FDA can also terminate any INDs, meaning no more trials. That potentially shuts down his use of antineoplastons in any situation, since even emergency use exemptions require an IND.

    They may also disqualify the investigator. In such situations, the investigator cannot receive or conduct research using an investigational drug/device. Alternatively, they may simply restrict the investigator, allowing him to conduct research and receive investigational products, but only under certain conditions (e.g., all activities must be done under the supervision of another qualified researcher).

  11. #11 Guy Chapman
    United Kingdom
    March 26, 2013

    I very much do think that it’s next stop Tijuana. Burzynski seems to me to have given up all hope of gaining approval for ANPs, and is clearly not about to entertain the idea that he might be wrong.

  12. #12 JGC
    March 26, 2013

    Based on his failure to publish a single completed Phase II study in more than 2 decades, I really don’t think Burzynski ever really sought to gain FDA approval for ANP’s. All he was seeking was the ability to keep charging people to receive treatment at his clinic, and the appearace of seeking approval by conducting (but never completing or publishing) clinical trials was just a necessary means to that end..

  13. #13 Dorothy
    Oz--the other one
    March 26, 2013

    It seems pointless to devise scenarios where Dr. B is shut down, only to spring up somewhere else, especially when that place is relatively easy for the marks to get to. He needs to be jailed for a long time and his evil spawn needs to be threatened with the same penalty if he takes up where Dad leaves off.

    Wouldn’t an analysis of the records determine if his “success” rate is any better than any other cancer treatment center? It seems that if his operation was exposed as not being any better than anything else (as Orac does here with making it clear that this “therapy” is indeed chemo), then people will lose interest in trying to obtain it.

    So rather than trying to get an underfunded and overburdened (to say nothing of politically hamstrung) FDA to get him for medical trial abuse, maybe we should just keep at discrediting the whole concept of antineoplastins being anything but poorly monitored chemo? Then the question is how to get that message spread as widely as possible.

  14. #14 Todd W.
    http://www.harpocratesspeaks.com
    March 26, 2013

    @Dorothy

    I’m still of the opinion that a good treatment by Frontline could help. Their investigations tend to be pretty good.

  15. #15 sheepmilker
    March 26, 2013

    Todd, there has been mention on Twitter that “Panorama”, a BBC investigative programme, will be doing something on Burzynski. Should be interesting!

  16. #16 Bob
    March 26, 2013

    Perhaps someone would write to the producers of Frontline and pitch the story?

  17. #17 Chris
    Uk
    March 26, 2013

    I am looking forward to Panorama. For those of you not in the Uk they don’t usually pull any punches, a high profile BBC investigative program.

  18. #18 JustaTech
    March 26, 2013

    I cannot believe that he is still allowed to run ‘trials’ after failing to report a serious adverse event. A serious adverse event is just that, serious, and even one can end up pulling the plug on a trial, because something is obviously not safe.

    Ethics: you’re doing it wrong!

  19. #19 BugLady
    Houston TX
    March 26, 2013

    I’m sick to death of having to drive by his clinic every day on my way to round at one of our local LTACs. Frankly, if this makes him move to California… Hooray! He is an embarrassment to the medical community here in Houston.

  20. #20 Liz
    Redmond, WA
    March 26, 2013

    I monitor oncology clinical trials for a living and this whole situation makes me sick! How can the FDA let this go on? As mentioned in other comments, there is PLENTY the FDA can do to completely shut this guy down.

  21. #21 Jergen
    March 26, 2013

    He must have naughty pictures of someone at the FDA.

  22. #22 rjblaskiewicz
    March 26, 2013

    Liz,

    Do you have any idea about how we make this happen?

  23. #23 Politicalguineapig
    March 26, 2013

    Liz: How can the FDA let this go on?

    I was under the impression (perhaps they are too) that the FDA cannot operate in Texas. A great many rules do not apply there, since it is a border state.

  24. #24 Narad
    March 26, 2013

    I was under the impression (perhaps they are too) that the FDA cannot operate in Texas.

    No. The FDA cannot regulate intrastate commerce (which is why the TMB had to tell Scamley that he couldn’t sell them in-state, either). That’s it. They still have full authority over the trials.

  25. #26 thenewme
    March 27, 2013

    Would the FTC be a more effective avenue than the FDA?

  26. #27 zackoz
    Australia
    March 27, 2013

    Narad, if the FDA has authority over the trials, surely they can shut them down? Or have I misunderstood you?

    Orac, this had me confused:

    “In the midst of this, apparently an audience member asked Mini-B (my name for Greg Burzynski, Stanislaw Burzynski’s son and heir apparent to the Burzynski cancer empire) said that they had thought about it and that “everyone has an opinion.” ”

    I didn’t understand this. Is something missing from the sentence?

  27. #28 Narad
    March 27, 2013

    Narad, if the FDA has authority over the trials, surely they can shut them down? Or have I misunderstood you?

    Sure they can. This 21 CFR 312. The whole “FDA cannot operate in Texas” routine was just some babbling from Squidymus that he picked up from Ralph Moss.

  28. #29 Narad
    March 27, 2013

    ^ “This is”

  29. #30 lilady
    March 27, 2013

    @ zackoz: If you reread the entire paragraph, according to Orac’s interpretation of the “mole’s” notes. there were a number of Dr. B’s *supporters* in the audience who were “ranting” about the FDA and “health freedom” (nonsense).

    Dr. B’s son, was asked about “it” (the FDA, I presume), and Dr. B Jr. replied “everyone has an opinion”.

    IMO, Dr. B Jr. gave a very vague reply, and IMO, the vague reply was deliberate to avoid answering any additional questions that might be posed about why the FDA inspectors were going through the clinic’s IRB records.

    I have a suspicion that the 10 days the FDA inspectors were checking the IRB’s records…is just a small piece of the records they were going through.

    “Everyone has an opinion”..or…”Opinions are like a$$holes, everyone has one” :-)

  30. #31 zackoz
    March 27, 2013

    Thanks Lilady, that clarifies it. I could well imagine that they wouldn’t want to go into detail about why they were being investigated.

    Thanks also to Narad. So the FDA has the authority, but I assume no one is taking bets that they will actually assert that authority.

  31. #32 Orac
    March 27, 2013

    Didymus’ argument is hilarious in his latest “post” TrackBack above. Basically, it boils down to saying that other IRBs sometimes get caught. Saying in essence, as Diddy-ums does, “Hey, they do it too!” is not generally considered a particularly compelling defense, except perhaps among seven year olds.

  32. #33 Todd W.
    http://www.harpocratesspeaks.com
    March 27, 2013

    Re: Why the FDA hasn’t acted before to shut him down

    I have a couple guesses on this. The biggest reason I see is resources. FDA has a huge range of products and people they need to regulate. I suspect that Burzynski was viewed as relatively small fish in the grand scheme of things, and so was relegated to a middling spot on the list of things they need to focus on.

    The other thing at play is that even though FDA does have authority to do quite a bit, from what I’ve seen they tend to take the least-disruptive approach and escalate as needed: warning letter first giving the offender a chance to correct what they’re doing, for example. It’s a reasonable approach. I mean, you don’t want to just shut someone down who might be willing to follow the rules but, through ignorance, perhaps, made mistakes. Even after the first investigation, it may not be clear, particularly to someone removed from the subject to know who are the good eggs and who are the bad ones.

    Then there are the regulatory requirements that FDA must follow, like minimum timeframes they must follow and how that clock can be reset under various circumstances.

    I think the biggest thing, though, is the decision for how they allocate resources.

  33. #34 Krebiozen
    March 27, 2013

    I suspect the FDA don’t see Burzynski as a priority because he is generally ‘merely’ offering false hope to patients who are very unlikely to survive anyway. If he were persuading patients to forgo treatments that had a good chance of curing them or of significantly extending their lives, perhaps they would see him as a target worth expending their resources on, but he seems to walk that line very carefully without ever quite crossing it. Sadly there are plenty of even more dangerous quacks for the FDA to pursue.

  34. #35 Todd W.
    http://www.harpocratesspeaks.com
    March 27, 2013

    @Krebiozen (#34)

    Exactly. His overall impact, in the greater marketplace, is relatively minor. Unfortunately, he has a large negative impact on that smallish slice he attracts. While it would be nice for the FDA to finally take action against him, there are bigger fish to fry, which is why it’s so important that people like Orac, Bob Blaskiewicz, Josephine Jones, The 21st Floor and others to keep on him. The more negative publicity he gets, the easier I think it will be for the FDA to justify acting.

  35. #36 Lawrence
    March 27, 2013

    @Todd – with the issues with Compounding Pharmacies right now, along with the Budget Sequester, I can see why Dr. B isn’t a priority, but hopefully if they’ve already gone down this road to a point, they can come up with something to at least start holding him accountable……but, we’ll see.

  36. #37 Todd W.
    http://www.harpocratesspeaks.com
    March 27, 2013

    @Lawrence

    Indeed. Definitely some big issues that have a much broader effect on public health.

    But at least they have the warning they sent to Dr. B’s IRB several years ago, which the IRB apparently didn’t bother to respond to (the warning letter was not closed out). So, there’s at least a basis established for FDA to escalate whatever actions they may take, rather than just another warning letter and several more years of waiting for a reply, especially considering the failures this time round are nearly identical to the issues in the first warning.

  37. #38 Narad
    March 27, 2013

    Basically, it boils down to saying that other IRBs sometimes get caught.

    It’s amusing that he cites Texas Applied Biomedical, since upshot of the very letter that he’s copying and pasting from was that the IRB had approval of all its new trials withheld and enrollment in existing trials suspended until and unless they were able to get their act together. I take it that he would have no problem with such an outcome in this case.

    One interesting tidbit from the December 2008 inspection is that, apparently, the PI on one of the relevant studies had received an NIDPOE for “administering a [sic] investigational new drug (IND) [redacted] to study subjects without an IND in effect, violating a clinical hold by giving subjects [redacted] after FDA issued an order to delay the proposed clinical investication, and failing to obtain informed consent in accordance with the Code of Federal Regulation (CFR) statues [sic]. That’s quite a hammer.

  38. #39 ChrisP
    March 27, 2013

    I dropped Didymus a comment on his blog. He hasn’t had any comments and I figured he might be feeling lonely.

  39. #40 Denice Walter
    March 27, 2013

    @ ChrisP:

    OMFG! I skimmed over Diddy’s blog- post by post including references to myself…
    There are seemingly endless cascades of verbiage, aren’t there?

    I was reminded of the scene in ‘A Beautiful Mind’ when Nash’s wife discovers what he was ‘working’ on for months in secret.

  40. #41 Bob G
    Los Angeles
    March 27, 2013

    OT — Karen Black raises money to get cancer treatement in Switzerland:

    http://abcnews.go.com/blogs/entertainment/2013/03/karen-black-cancer-fundraiser-takes-off/

    When this story broke a few days ago, the actress and her husband were looking to raise about $22,000 to cover travel and living expenses for an experimental treatment in Switzerland. Unlike some of the other cases we read about here on RI, Black had fairly aggressive traditional treatment including surgery, radiation, and chemotherapy, but her ampullary cancer came back and she has metastatic disease. The other difference with this case is that the experimental therapy was apparently recommended by a doctor of hers. The public funding appeal has worked to the tune of about $45,000. This seems like a lot to me, but it is also small change compared to customary costs in American hospitals, and seems to be small change compared to the Dr B stories.

  41. #42 elburto
    March 28, 2013

    @Denice – I’m imagining the opening scene of Burzynski 3: And on the Third Day…

    [start scene]

    The scene fades in. A backlit screen glows coldly. It provides the only source of illumination in the murky gloom of a room that seems almost subterranean due to the total lack of natural light.

    Diddums is feverishly banging away on his keyboard, at a disorganised and cluttered desk.

    As our eyes adjust to the murky conditions we see evidence of food and drinks in various stages of decay, littering the room and radiating outward from his position at the desk. There are ashtrays so overflowing that they look more like mole hills, and every surface (bar the ceiling) is covered by hypergraphia and stained with the greasy residue from cigarette smoke.

    The camera pans upward to reveal a Twistine Chapel ceiling fresco of his beloved Saint Scamislaw, smiling beatifically, arms opened wide, and surrounded by a host of cherubim with Hickman lines and backpacks full of ANP pumps..

    Suddenly an anguished howl breaks the silence. The camera pans back. to Diddums, clutching his head in his hands and rocking back and forth. A stream of indecipherable wailing pours forth from his mouth as the camera zooms closer to the spittle-flecked monitor to reveal two words in stark black on white…

    RESPECTFUL INSOLENCE

    The camera fades to black with the shrieking continuing to echo around the room.

    [end scene]

  42. #43 Broaire
    USA
    March 28, 2013

    Why would dvorit samid try to steal his patent, the texas board of medicine try to strip his license and FDA witch hunt to the tune of 60 mil if there was nothing to it. Where did all the cured people come from? Actors. I think opinions are like armpits. Every one has two.

  43. #44 elburto
    March 28, 2013

    Which “cured people”? Some names would be lovely, along with proof of their original diagnoses and evidence of 5+ years of survival after being labelled “no evidence of disease” by an actual oncologist.

    Should be really easy though, yeah? Thanks in advance!

  44. #45 herr doktor bimler
    March 28, 2013

    Why would […] the texas board of medicine try to strip his license and FDA witch hunt to the tune of 60 mil if there was nothing to it.
    This is an interesting argument. If the Texas Board of Medicine and the FDA treat Burzynski as a fraud, this proves he is not a fraud. What?

    Where did all the cured people come from?
    Also, where are they now?

  45. #46 Broaire
    USA
    March 28, 2013

    Watch the credits at the end for names
    http://www.youtube.com/watch?v=0zBBfN5mQa8

  46. #47 Broaire
    USA
    March 28, 2013

    Shouldn’t take a rocket scientist to check them out
    http://www.youtube.com/watch?v=0zBBfN5mQa8
    Logical question why would elan want to steal the patent and have ten or 11 patents filed under their surrogate dvorit samid if they did NOT think they would profit from a “useless” treatment. Please not all people are doctors but we are not stuck on stupid either.

  47. #48 LW
    March 28, 2013

    Logical question why would elan want to steal the patent and have ten or 11 patents filed under their surrogate dvorit samid if they did NOT think they would profit from a “useless” treatment.

    And where is the wildly successful and lucrative treatment resulting from the stolen patents?

    Are you aware that Burzynski’s early patents have expired, so anyone who cared to could start producing wildly successful and lucrative treatments based on them? Yet somehow no one has. Odd, isn’t it?

  48. #49 elburto
    March 28, 2013

    No, pretty sure I asked for proof of Burzynski patients who have spent five or more years with the label “no evidence of disease” from a legitimate oncologist.

    Crucially, we need proof of the original diagnosis, and that they didn’t receive any form of conventional treatment prior to, or after, their time on ANPs.

    YouTube credits aren’t documentation, sorry! Also, I can’t watch the video, but I’d take a punt on at least one of those names being dead or seriously ill.

  49. #50 Broaire
    USA
    March 28, 2013

    I watched the film on Netflix in its entirety and was a skeptic however once you see the lengths the state, fda, nci, and us govt went to discredit the man only to lose every time it makes you think

  50. #51 AdamG
    March 28, 2013

    How are you a skeptic if you took the movie’s claims at face value?

  51. #52 Narad
    March 28, 2013

    Why would dvorit samid try to steal his patent

    Perhaps you’re unclear on the concept. It’s not possible to “steal” a patent. Scamley has plenty of patents. So, if you’re going to regurgitate make this assertion, go through the relevant patents and identify the “theft” for everyone. Note that this does not mean listing patent numbers or quoting from a Burzynski interview, it means reading them and demonstrating which were “stolen.”

  52. #53 Chemmomo
    where citations don't include "youtube"
    March 28, 2013

    AdamG,

    How are you a skeptic if you took the movie’s claims at face value?

    Well, Broaire did use past tense: was a skeptic.

    However, I’m pretty sure Broaire and I don’t share the same definition of “skeptic.” Mine does not include the characterization “is easily swayed by watching videos.”

  53. #54 Melissa G
    March 28, 2013

    For comment #42, I LOL’ed so hard, elburto! :D :D :D Well done.

  54. #55 elburto
    March 28, 2013

    I watched the film on Netflix

    Oh I love Netflix! I can’t believe that the government is pitching kids against each other, in a battle to the death, to punish them for the sins of their ancestors. Isn’t that horrible?

    Saw it on Netflix, must be true. Film does not lie, I mean how can it? It’s right there on the screen.

  55. #56 elburto
    March 28, 2013

    @Melissa – Thanks! I have Joel and Ethan Coen attached to direct. That should bring us some top Hollywood talent to star as Diddums and Count Scamula.

    Oh, and Pixar have agreed to work on the plexiglass box of blinking lights. It’s so exciting, it’s the first time they’ve worked on a character for a live action movie.

  56. #57 Melissa G
    March 28, 2013

    Oooh, I’d love to see Clooney as Diddums and Billy Bob Thornton as Scamislaw! DREAM CAST!!!

    I know he’s not even in this movie, but I see Quentin Tarantino as Jake Crosby.

  57. #58 herr doktor bimler
    March 29, 2013

    Watch the credits at the end for names

    Names in movie credits are not required to be real people.

  58. #59 Krebiozen
    March 29, 2013

    Broaire,

    Shouldn’t take a rocket scientist to check them out

    If you mean Jodi Fenton, Jessica Ressel and Kelsey Hill, you should probably read Orac’s take on the movie and those 3 cases.

    In short, Jodi Fenton had surgery and was tumor free just 3 days after starting antineoplastons, which strongly suggests it was the surgery that cured her, not the antineoplastons.

    Jessica Ressel apparently didn’t have a biopsy, so we don’t know what the mass seen on MRI actually was, only that it grew and shrank erratically without any noticeable relation to the treatment she was given, and eventually disappeared. It could have been a malignant tumor or a benign tumor, we simply don’t know.

    Kelsey Hill’s diagnosis was also questionable, her biopsy don’t provide the necessary data to say if she had a malignant adrenal cortical carcinoma or a benign adenoma. Her adrenal gland tumor was removed surgically and the “metastases” in her lungs and liver were never biopsied, so we don’t know for certain what they were. Whatever they were they grew for the first few months on antineoplastons.

    I’m not a rocket scientist, but I don’t think those cases are very impressive. What we really need are some clinical trial results, but Burzynski seems curiously disinclined to share these with us.

  59. #60 JGC
    March 29, 2013

    Broaire, let me try to explain something to you: the flm you watched on Netflix isn’t evidence that ANP’s cure advanced stage cancers.

    The claims made by the patients appearing in the film that their cancers were cured by ANP’s aren’t evidence that their cancers actually were cured by ANP’s.

    The fact that the FDA acted when they had found the clinic’s use and advertising of ANP’s for treating cancer unlawful isn’t evidence that ANP’s work.

    The fact that the TBM has tried t revoke Bursynski’s license to practice isn’t evidence that ANP’s work.

    You know what would be evidence that ANP’s work? Published results from clinical trials demonstrating their efficacy.

    And you know what else? Burzynski has initiated more than 60 Phase II clinical trials over the past few decades to demonstrate ANP efficacy, but has not published results from a single completed trial. Nothing. Nada. Zip.

    So tell me, Broaire, why do you think that is?

    Is Burzynski witholding publication because the trials don’t demonstrate ANP’s work, but he wants to be able to keep charging patients exorbitant amounts to receive treatment at his clinic?

    Or is it because they instead show ANP’s do work but Burzynski is keeping the evidence secret to maintain a very lucrative monopoly on the treatment, thereby denying millions of cancer patients around the globe affordable access to a cure for their disease?

    After 20 years/60 trials there either is hard evidence that they work or there is no hard evidence that they work. So take your pick: is he a conman or is he a monster? He’s one or the other.

  60. #61 Krebiozen
    March 29, 2013

    JGC,

    Burzynski has initiated more than 60 Phase II clinical trials over the past few decades to demonstrate ANP efficacy, but has not published results from a single completed trial. Nothing. Nada. Zip.

    It’s actually even worse than that, since he has published selected bits and pieces from those Phase II trials that appear to show antineoplastons are effective.

    That seems to me to be a bit like me claiming I have the paranormal ability to make a coin come up heads every time, and showing as evidence a movie made from clips of the fifty times out of a hundred that a coin I tossed came up heads, and omitting the fifty times it came up tails.

  61. #62 elburto
    HMS Critical Thinking
    March 29, 2013

    Krebiozen- That’s how all woo and flim-flam merchants operate though, isn’t it? Celebrate the hits, ignore the misses, and blame any failure on the victim’s lack of faith.

  62. #63 Stacey H
    Washington State
    April 17, 2013

    I’ve met Burzynski personally, Orac, and you hit the nail on the head. To call him arrogant is a gross understatement. He is, quite possibly, the most arrogant person I’ve ever met in my life, as are many of his billing staff. My 26 year-old daughter was diagnosed with an inoperable Anaplastic Astrocytoma on her optic nerve in August 2012. She was a failed subject of Dr. Burzynski’s clinical trail late last year. My biggest issue with them right now is that fraudulent billing by his billing department. I was made to take out a large loan so I could pay everything up front; they sneakily collected from my insurance as well, and now refuse to refund thousands of dollars in overpayments! They are a den of liars and thieves, in my opinion. If anyone does deal with them, I warn you to get everything in writing and pay careful attention to their reluctance to provide this. It is telling. The problem is, by the time you visit this operation, you are so desperate and vulnerable you will listen to anything, sign anything do just about anything to save yourself or the person you love. I say this only to show that this man and the way he runs his business appear to be unethical on every level.

    Mini-B?!? I laughed myself silly over that one.

  63. […] website in January. It is believed that following a recent inspection, the US FDA have closed the “clinical trials” loophole that had been allowing Burzynski to sell these old, unproven drugs to terminal cancer […]

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