Is the FDA Protecting Burzynski?

And if so, why? Last night is had a phone call with Elisabeth Lee, Regulatory Counsel, Division of Information Disclosure Policy at the Center for Drug Evaluation and Research. This was in relation to my request under the US Freedom of Information Act, which I submitted on 7th February. Here is the text of my request:

Please provide the reference(s) for the following publication(s):

All studies demonstrating efficacy of antineoplaston treatment, submitted by The Burzynski Research Institute, and/or Dr Stanislaw Burzynski, and/or The Burzynski Clinic, in support of the application to proceed to phase III clinical trials.

Please note that, as approval for phase III has been granted by the FDA, and there is now an obligation to publish hypothesis-testing research, it is to be expected that the information I have requested will have either been published, or is pending publication. If the latter is the case, please state where publication will take place.

I received an acknowledgement via snail mail dated 9th February, and nothing after that until I started chasing last week. The US FOI Act has the same 20-day response benchmark as ours does, so this was a long way over. The request was passed from pillar to post until it arrived on the desk of Ms Lee, who emailed me and asked me to phone her. Here are some highlights of the conversation.

EL: This is a complex request. Have you made previous FOI requests to the FDA?

Me: No, not previously.

EL: Well complex requests normally take 18-24 months for a response.

Me: Excuse me, but what is complex about it?

EL: A simple request is something that is already available, that we would pull from our databases, in a short amount of time. The FDA is not able to confirm or deny the existence of any information on new drug applications, or to confirm the status of new drug applications.

Me: What puzzles me is how the FDA has allowed at least 61 `trials’ to be conducted, without showing any evidence of efficacy. My understanding is that in order to get into phase III one would have to show some efficacy from earlier phase studies. Is this information you can’t give me?

EL: (Long pause): Erm – we can’t discuss drug research prior to approval of the drug.

Me: You do realise of course that this drug has been investigational for over three decades?

EL: I understand…..

Me: So this could go on indefinitely?

EL: I can’t speak to that unfortunately.

Well you get the drift. The conversation went on like this for several minutes more, with every question stonewalled. So let’s summarise:

  • The FDA has been approving clinical trials which don’t meet the most basic of scientific standards (that the FDA would demand of drug companies).
  • The FDA does not consider that charging desperate people huge sums for an unproven treatment is unethical.
  • The FDA is not worried about non-compliance by the Burzynski Research Institute’s institutional review board (ethics committee) and the Institute itself, because it has not closed out the warning letter. Note that I regularly get notified by the FDA of regulatory action being taken against other IRBs and investigators.
  • The FDA has given approval for a phase III trial but refuses to justify that approval.

The FDA has used the `complex request’ option to block this request. In fact it is not complex at all. The FDA has given phase III approval, and will have issued that in writing to the applicant. The document is readily available. It is curious that the FDA is trying to use two ways of blocking this request. One is that it’s a `complex request’, which it isn’t, and the other is that all information prior to drug approval for marketing is confidential. My guess is that they are using the first in order to defend their failure to reply within 20 days, and the second as `belt and braces’.

But I am of course not sufficiently familiar with US law, and would value contributions from American friends. There is something very odd going on here.

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17 Responses

  1. Say the FDA is against Burzynski because they are in the pockets of Big Pharma, and say that the information that they hold generally supports the efficacy of his anti-neoplaston treatment. Would this explain their failure to reply promptly to your FOI request?

    • I can’t see how your comment makes the slightest logical sense. After 30+ years of research, if there were good efficacy data would it not by now have been published? Why does Burzynski have to fund his operation by extorting money from desperate people, when a venture fund would be glad to support a revolutionary cancer treatment? That would turn Burzynski into Big Pharma! You miss the point that the standards the FDA demands of Big Pharma (and I know, having worked in drug development for 35 years) are vastly more rigorous than they have been letting Burzynski get away with. I want to know why.

      • OK, so why do you think they let him get away with it?

      • I genuinely have no idea why the FDA is doing this, hence my questions. Maybe there is some legal loophole they don’t want more people to know about. Look, unlike many other national regulators, the FDA runs a blacklist of disqualified investigators. It’s tougher on non-compliant investigators than most regulators are. Also, there is ample justification to inspect Burzynski, but they won’t do it. Why? They simply refuse to say.

    • If the FDA were trying to suppress Burzynski’s data, why would they give permission for a Phase 3 trial? That is a clear attempt to force him to publish his results, which he has refused to do for years. I doubt Burzynski will do a phase 3 though, because he doesn’t want that kind of scrutiny.

      • I believe that that is most likely the case. Burzynski has had several legal wins against the FDA in order to get his phase I and II trials going. He has had phase III for some time now, but doesn’t appear to be moving forward since it would further expose him as the fraud that he is.

        Meanwhile, patients continue to fall for his snake-oil and those of us on the non-profit side are dumbfounded as fundraisers for his patients drain resources.

  2. Just got response from FDA. My request is denied, reason given is “Trade secret and confidential information”. Where do we go from here? Is there not a single elected representative in the USA who cares enough to ask the FDA some searching questions?

  3. [...] Is the FDA Protecting Burzynski? (majikthyse.wordpress.com) [...]

  4. [...] Supporters of Dr Burzynski often argue that the FDA have been part of a conspiracy to suppress him. However, the FDA have continued to approve Burzynski’s clinical trials. They don’t seem to have taken regulatory action against Burzynski since the 2009 warning letter to the Burzynski Research Institute. They have even approved a phase III trial. It could even be argued that the FDA are protecting Burzynski. [...]

  5. Uau, guilty if you do, guiltier if you don’t
    Nobody actually answers the questions: does he cure? does he not cure?
    If he is a quack, he would be behind bars and not be able to go to phase 3. Now to hint that FDA is protecting him that is precious.
    All blogging crap, zero investigatory work
    Proof people, proof

    The web is full of air shakers, of you don’t plan to say anything meaningful keep your traps shut

  6. Hey

    Got a great idea for you bloggers:
    Open your(advertised) blogging site, rant about something with loads of hits(check google for this).
    In this case, blog about Burzynski, he seems to be on the news.
    In fact, I will do this and make some cash while I am at it.
    Ah….
    being a professional critic: produce nothing, make money, just like the banking industry :-p
    This is me shaking air now

    • I would like to reply, but your comment is largely unintelligible. Read properly and you will find investigative work. There is such a thing as free speech, which is why I have approved your abusive comment.

    • Hurrah! The “paid shill” gambit. Only one problem: Burzynski is getting rich on this, whereas we’re not. Do please drop Big Pharma a line on our behalf and ask them to get the cheque in the post Real Soon Now or we’ll start busting their chops about their manipulation of drug trial data.

      Oh, wait, we’re already doing that…

  7. That is really funny to find this blog.
    “f he is a quack, he would be behind bars and not be able to go to phase 3. ”

    Logically incorrect, a lot of people was speeding on the freeway and only a few got busted.

  8. Phases of clinical trials
    http://en.wikipedia.org/wiki/Phases_of_clinical_research

    Citation
    Phase III
    Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current ‘gold standard’ treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions. Phase III trials of chronic conditions or diseases often have a short follow-up period for evaluation, relative to the period of time the intervention might be used in practice.[4] This is sometimes called the “pre-marketing phase” because it actually measures consumer response to the drug.

    To perform phase III it is needed around $20 000 000 – $30 000 000.

    • Sorry, that cost is utter rubbish. It is expensive to take a drug from initial development to approval, but Burzynski isn’t doing that. He already has a cheap generic drug, there are no drug development costs. The reason he won’t do Ph3 is because he would have to a) cooperate with the authorities and possibly a real cancer centre and he can’t afford that sort of scrutiny, and b) he would have to publish the results and he knows they would be negative.

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