The Burzynski Soap Opera

Burzynski’s Export Drive

The saga of Dr Stanislaw Burzynski and his antineoplastons (ANPs) is in danger of turning into a soap opera. Well actually it probably already has, as it has gone on for decades with no real plot and no end in sight. Many bloggers have been as puzzled as I as to why the US regulator, the FDA, allows this to continue. Admittedly, from time to time the FDA takes some sort of action, but it is never decisive – he is always allowed to carry on charging desperate patients vast sums to receive an unproven drug. First, let’s look a little more at what is happening here in the UK. I am indebted to Liz Woeckner of Citizens For Responsible Care and Research, who has identified at least 10 British patients who have travelled to Burzynski’s clinic in Houston, started treatment, and then returned home with supplies of antineoplastons (ANPs) in their luggage – apparently complete with IV administration sets. Liz has also compiled a pack of documents obtained form the FDA under Freedom of Information requests, which demonstrate the long history of serious regulatory violations at Burzynski’s facility. I’ll leave you to digest that lot.

Well, here is the list of UK patients that we have collated so far:

Luna Petagine (Raglan Gardens, Oxhey): http://www.lunapetagine.co.uk/diary

Amelia Saunders (Reading, Berkshire): http://www.ameliasmiracle.com/2.html. Note that Burzynski’s `exemption’ trial (ie patients could be treated outside an approved protocol) closed in 2006, and this patient was born in 2008 so must have been treated under an approved protocol.

Billie Bainbridge: http://www.billiebutterflyfund.org/billies-story/

Claire Faulkner: http://www.clairefaulkner.co.uk/

Hannah Bradley: http://teamhannah.com/

Laura Hymas: http://www.hopeforlaurafund.co.uk/

Chiane Cloete: http://helpmefightcancer.co.uk/

Supatra Emily Adler: http://supatrascancerfight.blogspot.com/p/home_10.html

Gus Lilly: http://web.archive.org/web/20110203164359/http://guslilley.com/

Andrew Sherwood: http://www.thesherwoodfoundation.org.uk/Home: Site has now been taken down.

Once I had this list, my first question was: if these patients are all taking ANPs (and apparently under FDA approved protocols), have UK physicians obtained ethics approval? Let me remind you that worldwide all clinical trials of investigational drugs must be reviewed by an independent ethics committee, and must have approval from the national drug regulatory authority. Not only does the ethics committee review the protocol, it also must review all patient-facing documents, including any advertising for recruitment to the study. That would include any websites.

Joan Kirkbride, Director of Operations, National Research Ethics Service, told me:

We have searched our database using the search terms: antineoplastons; A10 (Atengenal, Cengenal); AS2-1 (Astugenal, Fengenal) and Burznyski and have not returned any results.

“However Dr Burznyski would not be permitted to be a Chief Investigator for a trial in the UK as he is USA based and it is a requirement that such a person be based in the UK.

“My understanding is that there are other mechanisms to provide investigational medicinal products outside a clinical trial protocol eg for compassionate use but the MHRA would be able to provide further information in this regard.

Now hang on a minute, there are these trade names Atengenal and Cengenal. While surfing with those names, I also came across another one, Astugenal. Two of these, Atengenal and Astugenal, are being actively marketed by a California company Pediatrica USA, but not to US consumers. The company “acts as a patient’s representative so that these experimental yet potentialy (sic) life-saving drugs may be made available to developing countries. US residents cannot use this website.” Needless to say, the company operates in association with Burzynski. I would really like an expert oncologist to review the material on this site, in particular the descriptions of the mechanisms of action. But whether or not there is substance to the claims, the scenario is clearly one of exporting an investigational drug without a full dossier on efficacy, safety and quality. Is it not interesting that `developing countries’ are targeted? Would it not be more lucrative to export to say the EU? But of course, it also has tough regulatory legislation. The export drive is set out in this SEC filing, which lists the countries involved, and for which this contract engages a marketing company, Carigen.

I also spoke to the UK regulator, the MHRA, and learned that there had been no submissions for regulatory approval for ANP studies in the UK. I had already checked the EudraCT database and found nothing, although this is notoriously incomplete. The fact remains that if certain UK doctors are involved, they are not simply prescribing an unlicensed drug, they are acting as investigators for a drug classified by the FDA as in development.

I had another go at the FDA about these UK patients, but the reply (from the Center for Drug Evaluation and Research) totally avoided the question, and simply reiterated that ANPs are investigational drugs. Although I didn’t ask about illegal promotion, I did get this:

The FDA has sent an Untitled Letter to The Burzynski Research Institute (BRI) and The Burzynski Clinic for promotional and marketing claims about the safety and efficacy of its antineoplastons, investigational new drugs that have not been approved by the FDA.  The unapproved promotional claims made by BRI violate the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations. The promotion of investigational new drugs is prohibited by law and the agency is concerned BRI’s promotional claims will mislead patients about the safety and efficacy of the unapproved antineoplastons.  FDA plays an important role in ensuring sponsors provide accurate information about their investigational drug products to patients and health care professionals.

FDA requested that BRI submit a written response to the Untitled Letter by November 1, 2012, stating whether BRI intends to comply with FDA’s request that it cease the dissemination of violative promotional materials for antineoplastons, and explain its plan for discontinuing use of such violative materials. We are currently reviewing BRI’s response. Because this is an open case, we are unable to share additional information at this time.

That was on 7th November 2012 (sorry, there is so much stuff that this post took a long time!). Others I think have already picked up on the FDA’s warning letter, referring to this earlier website and also to the Burzynski Research Institute site. The two sites appear to have removed all promotional claims, but the Burzynski Clinic site still links to the patient group site, where you can find all the usual hyped-up claims.

Naturally I pressed CDER for an answer about exporting ANPs, and was simply referred to the legislation. It seems impossible to get a direct answer. But from exports, we move to imports, or the lack of them. This import refusal was issued by the FDA over two years ago. It appears that Burzynski was trying to get ANPs made abroad.

The FDA seems to be under fire from both sides. The patient groups constantly press for immediate approval of ANPs, as exemplified by this package sent to the Clinton administration (shows how long this has been going on). Look at page 31 – the FDA quite rightly refused to consider a submission for marketing approval from a single investigator.

Well this is a rather disparate collection of facts, but it reflects the vast complexity of Burzynski’s operations. To boil it down to essentials, there must be some UK doctors under whose care patients are receiving ANPs, and it’s not clear whether the imports and exports of ANPs are lawful. So far we have one name, Dr Simon Berrisford, cited by the parents of Burzynski patient Andrew Sherwood (site taken down as noted above). I do not know any more than that, indeed I do not know Dr Berrisford’s role, and I would not presume to ask him to breach patient confidentiality. But I am still curious as to what his role is. If he is operating as a co-investigator of Dr Burzynski, then he needs approval from a UK ethics committee and from the MHRA. There are no records of those approvals. If he is not operating as a co-investigator, then research data on an investigational drug are not being collected, as required by the FDA.

I have been looking at Burzynski’s study protocols, cached here. I am way out of date it seems – we have here 72 protocols listed. At www.clinicaltrials.gov there are only 62. Burzynski gives his protocols internal numbers, which don’t appear on clinicaltrials.gov, so it’s extremely difficult to work out whether we are talking about the same studies. However to take one example at random, protocol BT-7 is entitled “Antineoplastons A10 And AS2-1 In Patients With Glioblastoma Multiforme”, and was dated originally 1996. On clinicaltrials.gov study 60 has the same title, and is stated to have started in 1998. My suspicion is that here we have a bizarrely large number of studies, which are created to accommodate whatever patients come through the door (look at the vast range of conditions), and go on for decades. If that is not the case, I’ll be perfectly happy to publish a correction, but it’s up to Burzynski to show how I am wrong. Note the large number of changes to this protocol logged on clinicaltrials.gov, over the period June 2005- August 2008. Most of these are trivial, but I did notice that in 2007 the primary study indication was changed from “Recurrent Adult Brain Tumor” to “Brain and Central Nervous System Tumors”. This is quite unusual in my experience, and again suggests that protocols are being customised to suit patients.

I was deeply shocked by this paragraph in the informed consent section of protocol BT-14:

If your child is injured as a result of participation in this treatment, emergency care will be made available by the hospital and billed to you as part of your medical expenses. No financial consideration or compensation will be provided for a research related injury.

I have never heard of any such clause in any study, let alone receiving ethics approval. All clinical trials of investigational drugs are required to have insurance in place against drug-induced injury. This protocol is about as unethical as it’s possible to get. We already know that the institutional review board (IRB – or ethics committee in European parlance) is attached to the Burzynski Research Institute. Indeed it is called the Burzynski Research Institute IRB. It is quite clear that this IRB does little or nothing to protect patients. We also know that it received a damning inspection report from the FDA in 2008, but when I asked the FDA whether that had been closed out I got the usual stone wall. But again CIRCARE has the story. Some 10 months after the inspection, the FDA issued a warning letter, in October 2009. There is nothing on public record since then.

I have also been looking again at the investigator site inspection which the FDA carried out in 2001. Note that this was a `directed’ inspection, what we call these days `for cause’. It must have been in response to something that raised their suspicions. A possible cause could have been the detailed report published in The Cancer Letter in 1999, reproduced at QuackWatch with permission. Worth reading if you have the time. Anyway, here are the warning letter, the inspection report, and Burzynski’s response. The heavy redactions are of course excessive, and reflect the US obsession with secrecy. Note that item 6 of the warning letter states that Burzynski failed to include mandatory wording in the informed consent information. This demonstrates that ethical review is essential, and that it simply wasn’t happening. So far, I have been unable to identify any further action from the FDA, but as a clinical research professional here are my observations:

  1. The inspection report shows that Burzynski was at that time very clearly an incompetent investigator. International standards for Good Clinical Practice (GCP) say that everyone involved in clinical trials must be qualified by education, training and experience. Burzynski is not a board certified oncologist, which I would have thought was essential for what he is doing (I looked on the Texas Medical Board database). Why has he not been listed by the FDA as a debarred investigator?
  2. There is no mention anywhere of independent study monitoring. This is frankly baffling. It is a GCP requirement that three roles are in place, sponsor, investigator, and monitor. The last is normally carried out by a clinical research associate (CRA), who does inter alia the checking of case report forms versus source documents. They also check drug accountability, another major violation at the site. Obviously nobody was doing that, yet the FDA did not ask who should have been doing it. At inspections, it isn’t mandatory for the CRA to be present, but the documents on site must include a log of monitoring visits carried out. The inspector should check those to ensure the visits did happen. Everything checked by the CRA should have a signature to verify they did it. There’s not a word about any of this in the report.
  3. None of the documents includes the letters from the FDA which Burzynski claims give permission to treat patients off-protocol. I think it is very important to clarify what is going on here. If there is no such permission, then GCP applies to everything he is doing, wherever it is in the world.
  4. The FDA inspection report mentions that Burzynski was charging patients for ANPs. Yet they don’t list this as a violation. So why mention it? They seem to think it was unusual. The clue may be that the matter doesn’t come up in the warning letter, most likely because the FDA was not confident that such an allegation would stand up in court – in the light of Burzynski’s track record through the courts.

This post could easily go on for another four pages, so I think I need to stop here and let you assimilate it. More to come.

STOP PRESS! Just saw the post from Josephine Jones that suggests the BRI studies are on clinical hold. No point in asking the FDA for more news of course, we’ll have to wait and see. A while back I asked readers to press the FDA to inspect Burzynski, and now it seems they are. But I am intrigued as to the legality of suddenly shipping a vast load of ANPs to this patient – for which presumably they will get a huge bill.

14 Responses

  1. Small note: I don’t think Chiane Cloete is currently being treated by Burzynski, nor will she be, according to her father’s blog:

    “we spoke to, followed, and monitored a few children closely, that did go to Burzynski, and we feel Burzynski is not the way forward for us. Although Burzynski is very good, we feel, what Chiane requires and needs, is somewhere that focus more on her Gene dysfunctional diagnosis, which is lynch syndrome. ”

    http://helpmefightcancer.co.uk/2013/01/31/update-31-01-13/

  2. According to Count Burz’s hilarious grandstanding CV*, he owns the trademarks on those drug names.

    *Seriously, you have to see it – includes such gems as being ‘one of the youngest people to qualify as a doctor in Poland, aged 24′, (eg. at the same age as every other med student finishing the normal 6yr course) and lists some of his 212 patents including anti-cancer toothpaste (I shit you not).

    Oh yes, the scumbag claims to be a real Count as well. Just like he’s a real doctor.

    • Burzynsky, as well as several other “alternative medicine” practitioners and their methods are hyped and supported in the US by several prominent “Medihyperazzi” who earn megabucks from online aggressive marketing of expensive but useless products to desperate patients. These medihyperazzi or medihypesters always put forth the refrain that the imminent Nobel Laureates whom they endorse are being persecuted by The Establishment and Big Pharma who fear loss of profits from orthodox medical treatment (usually referred to by pejorative designations such as “slash and burn”), who would otherwise be cured by the alternative medicine treatments. Their obscene marketeering profits from their endorsed products enable them to hire batteries of high-powered lawyers to filibuster and otherwise protect them from action by regulatory agencies. As disparaged in (responsible) medical journalism, their products are always described as “amazing, miraculous, mind-boggling.. etc. etc” with the usual online marketing gimmicks such as “this amazing, miraculous, mind-boggling product, hitherto available only from an exotic source at $ or Eu 999.99 is offered from this site at only $ or Eu 499.99 only if you order by credit card in the next 10 minutes, plus $ or Eu 399.99 shipping and handling! As a bonus we will waive shipping and handling if you subscribe to our (newsletter, monthly purchase service, etc) with automated payments from your bank account or credit card at only $ or Eu 99.99 per month. Terms and Conditions apply. (Ten pages of legal jargon with liberal use of indemnify, hold harmless and other caveat emptor words and phrases for the purchaser to initial and sign are appended). In my ten years plus study of “alternative medicine” I have found it to be 99% marketing hype and BS, often invoking anecdotal, paranormal or fantasy elements in descriptions and testimonials. Add the 1% possible real benefits to the 30% placebo effect even with well informed patients gives a 31% therapeutic advantage to these treatments over no treatment. And so this industry thrives, as does narcotics peddling. Educating the public about the format of these scams, as does “Quackwatch” seems to be a good option, please circulate this opinion if you consider it valid.

  3. Pediatricusa.com gives an address of
    1150 El Camino Real Suite 141
    San Bruno, CA 94066
    ph: 6505805111

    This is actually a shopping mall, the suite is occupied by Dart Ops, a gaming arena: http://dartops.com/

    The phone number given has been used to register several other sites:
    ownlegacy.com
    pediatricmeds.com
    ownlegacy.net
    dartops.com

    Pediatricmeds.com is a dead site currently. Wayback doesn’t really show anything useful.

    Pediatricusa.com is a godaddy site.

    The owner of Dart Ops lists Burzynski among his favorites on Facebook.

  4. Why does it matter? It doesn’t. I just found it interesting that either the website development or the actual export of ANP to international clients is being handled out of CA.

  5. [...] The Burzynski Soap Opera majikthyse, 09/02/13 [...]

  6. [...] therapy except in the context of a clinical trial. Despite that, Dr. Burzynski has set up quite the cottage industry in which patients pay hundreds of thousands of dollars for the “privilege” of being [...]

  7. [...] therapy except in the context of a clinical trial. Despite that, Dr. Burzynski has set up quite the cottage industry in which patients pay hundreds of thousands of dollars for the “privilege” of being treated on [...]

  8. [...] his trials are of such poor quality that no reputable journal would touch them. Maybe his trials violate generally accepted ethical standards, which would also mean that no reputable journal would publish them. This is pure speculation [...]

  9. Of all those GB patients listed, they are all dead except Laura and Hannah who are still “in treatment”. and Chiane who didn’t go to Burzynski.

  10. The Soap Opera continues…
    Starring actors: Burzynski, Kiran Schmidt, john of god and by special appearance…THE POPE!!!!
    Episode 101…..“And for my next act…” Dr Buzynski honored by the Catholic Church
    Scene 1
    Kiran Schmidt, on bended knee emotes. .”It is my great honor to have Dr Burzynski , the world renowned Cancer therapist of Houston/ Texas , join the Medical Order of the Knights Hospitaller and his work honored by the Catholic Church by being initiated as “Commander of the Knight-order of St.Gregory the Great”‘
    Burznski….”I am beginning to see already the final third stage of the scientific revolution. I am “converting” oncologists and basic scientists all over the world to my ideas and now I am working on entire countries that have shown interest in introducing my approach of cancer treatment and prevention.. ..I can see the approaching paradigm shift”

    http://lakishajj.wordpress.com/2013/07/16/and-for-my-next-act-dr-buzynski-honored-by-the-catholic-church/

    Question: What do Burzynski, Kiran Schmidt and john of god all have in common?

    • Thanks – although with the Catholic Church such a vast, complex, secretive and ultimately pernicious organisation it appears hard to verify this claimed `honour’. I am still not sure of Burzynski’s mindset. I think he may be somewhat deranged, with delusions of grandeur, to the extent that anything he does is justifiable to him. Richard Nixon said “If the President does it, it is legal”. Same sort of thing.

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