Ask the FDA to Inspect Burzynski Research Institute

Why has this investigational site not been inspected by the FDA? I am going to write to the head of enforcement as follows:

Constance Lewin, M.D., M.P.H.
Branch Chief, Good Clinical Practice Branch I
Division of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Building 51, Room 5354
10903 New Hampshire Avenue
Silver Spring, MD 20993, USA

Dear Dr Lewin

Re: The Burzynski Research Institute, 9432 Katy Freeway, Houston, Texas 77055

The activities of this investigational site have attracted attention worldwide. For well over 20 years Dr Burzynski has been administering investigational drugs, which he calls antineoplastons, to patients with very advanced cancers. He charges extremely high fees for entering patients in what he claims are clinical trials. Hitherto none of these `trials’ has met internationally recognised standards of design. Of 61 protocols registered on http://www.clinicaltrials.gov, 34 are recorded as of unknown status, six have been withdrawn, and only one has been completed. There are only five publications from this investigator on PubMed indexed as clinical trials, but three appear to be reporting on the same study.

In 2009 The FDA issued a warning letter to the Burzynski Research Institute IRB, citing multiple violations. These violations implicated The Burzynski Research Institute itself in various breaches of Good Clinical Practice.  Can you tell me please why the warning letter has not been closed out, and why The Burzynski Research Institute has not received a for-cause inspection by the FDA? In particular, I am wondering how approvals for phase I and phase II trials could have been issued over so many years, when the protocols were so obviously of no real scientific value. For example, protocol NCT00003533 states its objectives as:

  • Provide treatment with antineoplastons A10 and AS2-1 for patients with incurable, metastatic, hormone-refractory adenocarcinoma of the prostate.
  • Describe response to, tolerance to, and side effects of this regimen in these patients.

The first objective has no scientific aim or predicted outcome. Please explain how the FDA can consider this to be acceptable practice. I am aware that BRI claims antineoplastons to be orphan drugs, but that does not excuse abuse of the scientific method.

To illustrate the level of concern many people have for this matter, I would direct you to a digest at:

http://josephinejones.wordpress.com/2011/11/29/burzynski-blogs-my-master-list/.

Here in the UK, the public is being asked to contribute to fund-raising efforts to pay for the treatment of children by Dr Burzynski. As a professional in clinical research, it is easy for me to see that there is no realistic prospect of success from this treatment. How does the FDA justify allowing this investigator to continue?

Yours sincerely

This will have to go via snail mail as I could not find an email for Dr Lewin. But her phone number is +1 301-796-3397. In any case a paper letter will be less vulnerable to the delete button. What if she got 50 such letters? Get writing.

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28 Responses

  1. Awesome. After I’m done teaching, I’ll totally send off my version.

    Let’s do eeet!

  2. Thanks guys for the email address. I knew it must be available somewhere!

  3. Excellent. Will be in the mail today. Would a change.org petition be of any use?

  4. [...] Majikthyse shows you how to ask the FDA to inspect the Burzynski Research Institute here. [...]

  5. Constance Lewin – was there ever a longer postal address in the history of the world?

  6. Email sent, using that letter as a basis (not verbatim, obviously)

  7. Do it! Maybe now the FDA will be forced to actually tell the world that the medicines work – on a public forum! This is a GREAT idea!

    • That would be great! If Burzynski really has a safe, effective treatment for cancer, then by all means, let’s get the evidence out in the open so more people will learn about it.

      Of course, if he’s a fraud who’s been abusing a weakness in the regulatory environment to enable him to bilk desparate people out of their money with a bogus therapy, then why wouldn’t you want him shut down?

      This is not a difference of opinion or a clash of personalities: the evidence either backs him up, or it doesn’t.

  8. [...] Ask the FDA to Inspect Burzynski Research Institute Majikthyse, 30/11/11 [...]

  9. Update for anyone who missed my Twitter feed. The FDA replied the same day and agreed to answer my questions by 9th December. So bookmark this page!

    • So, what did the FDA have to say? I suspect I know.

      • I got this last Friday:

        We appreciate you sharing the blog with us and have taken the opportunity to review your post concerning Dr. Burzynski.

        The information you received is FDA’s statement to reporters and consumers. Dr. Lewin followed CDER policy and will continue to do so by forwarding your inquiries to CDER’s Trade Press staff, who are responsible for directly responding to all Trade Press inquiries. We acknowledge your patience in the interim and regret missing your deadline. However, at this time, Dr. Woodcock’s response is the only information that we can provide with respect to Dr. Burzynski related inquiries. Please keep in mind that your questions all refer to an Investigational New Drug (IND) application. Details of an IND are proprietary and cannot be shared publicly by FDA.

        The last bit is not entirely correct. The warning letter already published relates to an IND (investigational new drug), so not all such information is confidential. I know very little about US law but I suspect there is a very strong public interest argument for overriding the need for confidentiality.

      • Have you tried contacting the US lawyer(s) who have blogged about Burzynski and Marc Stephens to check the US legality issues? There must be a bunch out there. [The guys at Popehat might be a place to start.] I’ve seen US Law School online material about healthcare law that uses Burzynski, and the judgements relating to him and his clinic, extensively as a teaching example.

        Anyway, think it might be worth a try in order to be able to respond authoritatively to the FDA’s comments about ‘for legal / regulatory reasons we can’t say more”, and the trade-off with the wider public interest. Several of the published US legal judgements on Burzynski that can be found online are quite explicit about the overriding duty of regulators to protect the public, and specifically to protect cancer patients with grim diagnoses who everyone recognises are in danger of being exploited.

  10. Gee, now you see what we are up against. Neither those “for” or “against” this guy can get any information out of the FDA – need we say more about how shady this establishment is? Face it you guys, the treatment is legit. Wake up and smell the science.

    • NoWay: I have no idea of what you mean by `legit’. What this is all about is whether it works, and the ethics of charging desperate people vast amounts of money for an unapproved treatment. So far, evidence of efficacy is virtually nil, and there is nothing special about `antineoplastons’ anyway. That is the science.

  11. I’ve been trying hard to get information, too. It’s damn near impossible. You think the FDA would jump on the chance of discrediting Burzynski but they simply aren’t coming up with ‘anything’ to support his illegitimacy. And as a skeptic, I’m searching high and low for it. What I have found is that he’s been approved for two phase III trials. Some level of efficacy must be proven or there would never have been phase III trials approved for recruiting. Never. It just doesn’t happen. Furthermore, one of these trials was formally announced on the Burzynski Research site in 2009. As a publicly listed company, if the media release of this trail was fraudulent, the US Securities & Exchange commission would have taken Burzynski to task in a second. No charges have been laid. I don’t understand the answer, but my skepticism is now swaying to the other side. Perhaps, Burzynski is not the fraud everyone is painting him out to be.

  12. majikthyse

    I wonder if the FDA are just being ultra-careful of what it says in case it prejudices future legal action?

  13. Where’s the evidence that Burzynski’s treatment doesn’t work? I don’t want to hear anyones opinion or skepticism based on … “I have a degree in (insert degree name)” or “I am a professional (insert profession here).” Those statements aren’t proof that you know what you are saying or that what you think is right in anyway. If it doesn’t work then where is the proof? If his treatment works even only a percentage of the time … how is that any different from the current forms of treatment that are completely backed by the FDA? Personally, if I was given a diagnosis that death was as close as a few months away … I would drink my own piss if I thought it would help. Why should the government have the right to step into my life and stop me?

    • Phatfly, you need to understand how science works. Science does not advance by proving negatives. In reality, that’s an impossible task anyway. The onus is not on anybody to prove Burzynski wrong. He is the one making the claim, so he has the obligation to provide the evidence. What if I were to claim that sticking a pickled earthworm up your nose will cure your cancer? Would you do it? Moreover, if I said that each earthworm costs $10000, would you pay? Frankly, there is no more published evidence in support of Burzynski than there is for the earthworm.

      What I have said here is not opinion. You ask how this treatment differs from FDA approved treatments. It differs in terms of evidence. No solid evidence in support of antineoplastons has been published. Good evidence in support of all FDA approved anti-cancer drugs has been published. That is the difference. My opinion is not important, the evidence is. No drug is 100% effective, but whereas (depending on how you define response) you might get a 70% response to an approved drug, we have no solid response evidence for antineoplastons.

      Also, it is hitherto unheard of to charge people money to participate in clinical trials. In normal clinical research, if any money changes hands, it is invariably in the other direction (that is most certainly the case for phase I studies, the type which Burzynski has been running for 25 years or so).

      “I would drink my own piss if I thought it would help”.

      So what makes you think it would help? The only thing that’s worth considering is the evidence. Anything else is fantasy.

  14. Hello All,

    Following is my post I made on:

    http://scienceblogs.com/insolence/2012/04/stanislaw_burzynski_kind-hearted_strange.php?utm_source=networkbanner&utm_medium=link

    today Wednesday 04/25/2012

    For even more on the Burzynski issue and a description of my special app I created entirely on my own
    rom scratch that provides a perspective of it unlike any other (or any other subject or topic for that matter) bring up:

    http://scienceblogs.com/insolence/2012/04/will_stanislaw_burzynski_slither_away_fr.php

    Two others in the same genre from the blog:

    http://scienceblogs.com/insolence/2012/03/dr_stanislaw_burzynski_strikes_again.php
    http://scienceblogs.com/insolence/2012/03/another_burzynski_patient_dies.php

    Again, Majikthyse I hope I did you proud.

    Joel S.

    ===============================================================

    Hello All,

    On 11/30/2011 “Majikthyse” who I perceive is from England sent a letter to FDA Good Practical Branch Chief Dr. Constance Lewin a “What the hell is going on with the FDA???” inquiry letter. Being from England he probably has less standing than an American citizen to get (a) response(s) from them but with the FDA’s long track history of deflection and obfuscatioin and ducking the issue with bureaucratic dribble (OK let’s call it is: Bullshit) and other delay tactics, it really doesn’t make much of a difference. Perhaps what does make a difference is as an American citizen in good standing and still alive lest my cancer takes me down which it ultimately probably will, I can submit a FOIA request letter. Here is the first of perhaps many (?) FOIA requests that I hope will bring some clarity to the Burzynski issue; at least who did (not) do what when. Hopefully “Majikthyse” if you see this I hope I’ve done you proud. Joel S.

    http://majikthyse.wordpress.com/2011/11/30/ask-the-fda-to-inspect-burzynski-research-institute/

    U.S. Food and Drug Administration (FDA) FOIA Officer Darshini Satchi
    U.S. Food and Drug Administration (FDA)
    10001 New Hampshire Avenue
    HILL-3111
    Silver Spring, MD, 20993-0002
    Re: Freedom of Information Act Request
    Wednesday, April 25, 2012

    Dear Darshini Satchi / FDA FOIA Officer

    This is a request under the Freedom of Information Act.

    I request that a copy of the following document concerning the following subject matter be provided to me:

    The notification letter to the Burzynski Research Institute (BRI) Institutional Review Board (IRB) that certifies and/or acknowledges that it has adequately and sufficiently rectified and/or addressed all the criteria and stipulations of the October 5, 2009 FDA Warning Letter composed or written by Dr. Kevin A. Prohaska, Acting Human Subjects Team Lead, Division of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration where he categorically cited the deficiencies of the BRI IRB procedures for the protection of human subjects.

    The FDA Reference code for this document is Ref: 10-HFD-45-09-01

    Here is the link to the document itself posted to the public at large on the FDA web site:

    http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192711.htm

    In order to help to determine my status for purposes of determining the applicability of any fees, you should know that I am an individual seeking information for personal use and not for a commercial use.

    I request a waiver of all fees for this request. Disclosure of the requested information to me is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the government and is not primarily in my commercial interest. I intend to post the full notification letter verbatim on the Internet as well as any additional commentary, if any, provided with respect to it by the FDA.

    I request that the information I seek be provided in electronic format, and I would like to receive it on a personal computer disk or a CD-ROM. If this is not possible a standard paper document will suffice.

    I ask that my request receive expedited processing because it will immensely contribute to my ability to evaluate and consider viable cancer treatment options that are the foundation of some of the most important decisions of my life. Furthermore the feedback and opinions from the public will only serve to enhance my study and evaluations thus my compelling reason to disseminate the results of my request to the public at large.

    I also include a telephone number at which I can be contacted during the hours of 10AM to 10 PM EST/EDT Monday through Sunday, if necessary, to discuss any aspect of my request.

    Thank you for your consideration of this request.

    Sincerely,

    Joel Shapiro
    119 Schilling Lane
    Rochester, NY, 14618
    Phone numbers in order of preference:
    (585) 255-0997 (Cell)
    (585) 473-7013
    (585) 250-8053

  15. [...] Ask the FDA to Inspect Burzynski Research Institute (majikthyse.wordpress.com) [...]

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