Dolcefino: "Burzynski has published!"

By Keir Liddle

images (5)Wayne Dolcefino has been engaged in a discussion over on the East England Skeptical Society blog with David James regarding the Burzynski clinic. Both sides currently seem very frustrated with one another and although the dialogue has been “mature” it does appear to have reached an impasse.

Though a number of comments given by Dolcefino via email and on the blog are very interesting:

“The clinic is actively compiling the data from it’s completed trial and is seeking to publish it in peer review journals. You want to see data published. So does the clinic. Dr. Burzynski knows this is a critical juncture for his research.”

I am sure all of Burzynskis critics will be delighted to hear that the clinic wants to publish and has finally reached this critical juncture at just a little over 35 odd years since Burzynski started exploring the use of antineoplastons as a cancer treatment. Equally I am sure all of Burzynskis patients who have been enrolled in his many, many, many, clinical trials over the years be delighted to know that their data will finally see the light of day.

I also further suspect that thousands of other patients with DIPG and Glioma will also be very interested to see Burzynskis results and delighted at the prospect he is finally ready to share his much touted revolutionary cancer treatment with them and the world. Particularly given his failure to publish has effectively meant that these thousands of patients worldwide could not receive Burzynskis ANP treatment.

We all been waiting a hell of a long time to see any of Burzynsksi results and when/if they surface it will be interesting to be able to finally confirm or deny a few little things regarding his research. /Alongside the question of whether antineoplastons show any convincing efficacy as a treatment of cancer it will be interesting to see if Burzynskis research protocols are as bad as has been previously reported.

However another interesting aspect to Dolcefinos’ replies to David James is the following statement found in the first comment below Davids latest blog:

“Ignoring the fact there are public SEC filings of interim data on 14 clinical trials available for you to analyze.”

So have all the critics and skeptics of Burzynski and ANP been grossly unfair in saying that the clinic hasn’t published trial result in peer reviewed journals?

No. Far from it. Given a SEC filing is is a financial statement or other formal document submitted to the U.S. Securities and Exchange Commission (SEC) and not, as you may have already guessed a peer reviewed medical or oncology journal.

A total of 78 filings from the Burzynski Clinic are freely available for use to peruse and analyse but what data is available and how is it presented?

The first report that states anything of interest is the Burzynski Research Institutes 2011 annual report. Which actually tells us what kinds of trials Dr. B claims he is conducting:

“All of the Company’s clinical trials, except one, involve the use of Historic Controls. Further, all trials except the CAN-1 study are “prospective clinical trials” (“PCT”). A PCT is a clinical trial wherein patients are accrued into and follow the clinical trial protocol from the very beginning of the trial. A retrospective trial is a trial in which data from patients treated prior to the start of a clinical trial is considered. Results of retrospective trials are, in most instances, not acceptable to the FDA. In addition, there are no clinical trials being conducted that involve “double blind” studies and all but one clinical trial involve no randomization into multiple treatment groups.”

It also contains some information about 14 of the research institutes protocols and states the results Burzynski is claiming from these. The protocols explore the use of ANPs on a range of brain tumours (primarily glioma) and of the protocols involve research conducted on children. The protocol results are presented in table form recording the number of patients recruited, the number evaluable for treatment and how many show “complete response”, “partial response”, “stable disease” or “progressive disease”. Terms we already know, thanks to Quackwatch and the cancer letter, that Burzynski has determined his own definitions for.

These protocols are clearly going concerns as figures are also available in the 2009 and 2010 reports.

What do I make of the data?

Well very little as of yet, though I intend to look at it more closely over the next few days, but I can report that, asides from the scant information described above, there is no detailed description of method, randomisation and not statistical analysis. I can also report that in EVERY single one of the protocol results reported by Burzynski in SEC filings the majority of patients showed progressive or stable disease.

There is in short absolutely nothing in these SEC reports that approaches anything like the rigour and information needed in a peer reviewed journal article. To determine if these reported results are worth a damn we need details of Burzynskis methodology and we need a rigorous statistical analysis.

As it stands the information contained alone within the SEC reports is about as valuable to medical research as an inflatable dart board is to Jockey Wilson.

But it raises a very interesting question if  the clinic has no problem publishing information for the SEC, why do they seem to have such problems publishing their trial conclusions in the past in peer-reviewed medical journals?

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16 Responses to Dolcefino: "Burzynski has published!"

  1. Keir,

    Read your latest comments and I just wanted to respond. First, I am not frustrated at all. I have told anyone who eliminates attacks on patients that I will try to get answers to the questions asked. I did not bring up the issue of insurance . I responded to a question . Then I am questioned for trying to change the subject, when I wasn’t who asked. I was only suggesting that if someone does not know the answer, they should be careful speculating, especially when they are wrong.

    I read you are a PHD student. I could not tell whether you are a cancer researcher, but I am certainly not one. I was asked about publishing data, and I responded with what the clinic tells me. They are analyzing the recently completed Phase 2 trials and are actively seeking publishing. I know you are aware it takes the biggest drug companies decades to often bring a drug to market. The trials began in the 90s. You quote me erroneously.

    I know the SEC is a financial government agency, and I was simply offering folks a place to look at the interim data for the clinical trials which were reported along with financial data because I was asked. I appreciate your clinical review did not totally satisfy your interest, but again I was just offering up that information because I was told it was there.

    I know you are skeptical, but I can tell you the clinic is actively working on the data and seeking peer review publication. The clinic is also following the guidance of the FDA about talking about the final results of the trials . If you want to criticize their silence, that is certainly your right. If you had invested years and alot of money into research would you jeopardize it .

    I appreciate the conversation. More than anything I just wanted to let you know you can always e mail me wayne@dolcefinocom.com . I have only been trying to get people to focus on legitimate questions, with the belief that every patient should research their options, and make the best decision they can in bad circumstances. You may not agree with the oncologists at the clinic, but that is why people fight so strongly here for choice.

    One other note, I notice people seem to have trouble with my comments about the vast majority of patients are not involved in clinical trials at the clinic. They are not. I am not sure how I can be any clearer.

  2. There are two issues with Burzynski.

    One I suppose falls under the research institute and that is the failure to publish. I remain skeptical that we will see these results but ever hopeful.

    The other is an issue with the “personalised” or “targeted” therapy that many believe isn’t actually targeted in the sense Burzynski claims.

    I appreciate the clarification of your position. I’m not particularly interested in the insurance issue (asides from how it relates to prior fraud investigations related to ANP prescription) as it besides the main point which is the worry that treatments and clinical trials are being misrepresented and missold. That any serious attempt at the publication of results has been so lacking. It’s worth noting that not only does the Research Institute publish “results” in SEC findings but Dr Burzynski is very willing to offer up unconfirmed preliminary results in conference abstracts. Which just looks dubious because there is a far less rigorous standard of scrutiny and peer review for conference abstracts than there is for medical journals.

    The main concern regarding Burynskis clinical practice, these are distinct from concerns about his clinical trials. In the main there is the concern that patients may be confused by the promotion of ANPs as “natural” and “non-toxic” by various vocal supporters of the clinic. When ANP is neither, it’s simply another untested (as it shall remain until pub) form of chemo and when it seems personalised therapy generally involved various mixtures of chemo drugs and orphan drugs.

    Quite how he has determined what combinations are effective or how is not really adequately explained by claims of genomic analysis.

    I am indeed a PhD student in health service research (from a psychology background) so I have a fair knowledge of how to design trials and studies and the interpretation of studies. Though I have some blind spots with some kind of pharmacological variants.

  3. Should add that Les is the cancer PhD.

  4. Appreciate your comments. We will watch how it unfolds together I hope. And I promise I will keep you posted . Feel free to e mail any time.

  5. I would welcome clarification as to what is meant by “attacks on patients”. I don’t know of anyone who has been attacking patients, but it is an accusation that seems to be cropping up quite often.

    • There have been incidences where swear words have been tweeted at the official accounts of patients fund raising campaigns.

      The only incident I actually saw was one individual swearing at the account (after they had been engaged in a long back and forth initiated by a third party IIRC) and this was roundly condemned by the vast majority of critics and skeptics on the hashtag. This occurred in December 2011.

      There was another brief incident recently when someone tweeted on the hashtag, not directed at any patients or individuals claiming to be relatives or friends of patients, that those appearing in Burzynski 2: were actors.

      This incident involved no swearing.

      These are the two I am aware of.

      It is also worth noting that one of @burzynskisaves favourite tricks on the hashtag is to mention both skeptics and patients families in his replies to Skeptics.

      His replies are typically designed to be combative and goad skeptics. Who enter into discussion with out realising they are also talking to patients families or patients themselves.

  6. Lawrence says:

    @Wayne – I do hope that all of the clinical results will be forthcoming, because I do hope that we (as a collective, skeptical community) are wrong, that Dr. B’s treatments are actually effective and offer hope to those who other would not…..because if they aren’t and it does turn out to be very much like we have surmised, then the clinic is going to have a lot to answer for.

    As a personal aside – have you asked the hard questions during the time at the clinic? Have you confirmed the details published regarding patient stories on “The Other Burzynski Patient Group?”

    Can you understand why we would feel the way that we feel, given the lack of actual evidence and concrete information that has been released over the last couple of decades? How about the lack of any real peer-review done on any of Burzynski’s treatments (not just ANPs, but his supposed “targeted” Cancer therapies)?

    Since you were an investigative reporter, I’m very interested to understand what led you to set aside your natural skepticism in this case.

  7. spikesandspokes says:

    Wayne

    Would it be possible to find out how many of the trials are deemed “recently completed” and the clinic are looking to publish, and how many are not going to be published, as it is not clear from the information that you have already provided or anything I have seen elsewhere. It would be something (in light of the All Trials intiative here in the UK)I would be very interested to know. Thanks, in advance, for any answer you may be able to get.

  8. I was aware of certain twitterstorms and of the @BurzynskiSaves tactic of copying patients into twitter conversations. If this is what Wayne is referring to as “attacking patients” then that is a gross exaggeration in my view, and wholly misleading. I also know of a couple of examples where skeptics have been in touch with patients or parents of patients, but I believe that they have always been polite and sensitive.

    This could be a genuine misunderstanding on Waynes part, which would be entirely understandable, given the behaviour of people like @BurzynskiSaves. Or it could be an attempt to give skepticism a bad name, and to distract from the real issues at hand here. It also seems to be based on a bit of a misunderstanding in that it assumes that Burzynski skeptics are an organised, co-ordinated group and that it would be possible for any one of us to “eliminate attacks on patients”.

    Also – even if we were mean, nasty, the scum of the earth and funded by pharmaceutical companies (as lots of pro Burzynski people seem to believe), that would still not solve or alter any of the problems with the Burzynski Clinic (I’ve already posted these on the post by David James that Wayne has already commented on but he might have missed them):

    The Burzynski Clinic has been:

    – Using an treatment for over 35 years without meaningful published data on efficacy and safety (the trials may only date back to the 90s but the use of ANPs does not).

    -Running large numbers of clinical trials without publishing data from those trials (SEC filings are not sufficient).

    -Charging patients to take part in clinical trials.

    -Sending out misleading information to prospective patients on the safety and efficacy of a treatment which is still considered new and investigational (information which is sometimes then reported in the press, effectively promoting the clinic).

    -Recommending dubious, misleading and unreliable websites to patients (such as the Burzynski Patient Group and Burzynski Movie sites, which give the impression that antineoplastons have been established to be safe and effective and the findings have suppressed).

    It is also an eponymous cancer clinic run by someone who is not an oncologist.

    Furthermore, there is a concern that Dr Burzynski and the Burzynski Clinic may also be giving patients false optimism concerning their prognoses. For example, there have been several instances where it seems Dr Burzynski or his staff have misread or misinterpreted MRI scans. Of course, we don’t know what the extent of this might be, but it is certainly a concern.

  9. I do think it is worth giving Wayne more credit than perhaps he has been given due to his association with Burzynski.

    But he would do well to remember that critics of Burzynski have been threatened with libel by his supporters, continually insulted and harassed by a minority of Burzynski supporters and almost never had any of their arguments refuted by the other side.

    I have only ever had one reply from the Clinic, via their official twitter stream, none to various emails. I have had no replies from the patient group (when informing them that they still hosted information about deceased patients) either.

    I’m not sure anyone else who has contacted them has heard anything back either.

    Also I am “looking forward” to a number of Skeptics being defamed in the next instalment of the Burzynki Movie in the abscence of convincing evidence of ANP efficacy.

    So we are coming from a position of mistrust. But one that is, I would argue, somewhat deserved.

  10. Keir,

    I know for a fact that the clinic has begun to contact peer review journals to publish the data from completed trials once it is finally analyed because I have seen the correspondence. Peer review journals I am told do not normally publish interim data. That data has been presented at neuro-oncology congresses and published as abstracts in a high impact peer-reviewed journal called’ Neuro-oncology’. If you cannot get a copy send me your address and I will forward from here.

    So there is interim data out there, and alot of it. As far as the Burzynski patient group, that is a separate organization, and I do not work for them, or have any involvement in what they do with their website.

    As far as this upcoming move, I do not work for the filmmaker. I am told he does not work for the clinic , or is being paid by the clinic.

    When I comment about attacks on patients I refer specifically to comments made by others I have read, even folks with Dr. in front of their names, that the patients who support Dr. Burzynski exhibit a cultist behavior. That is just plain silly. If you were told you were dying, and you went to a medical facility for treatment and years later you were happy as a clam , you would be singing praises too. I know I would.

    I appreciate your words in response. Anytime .

    Wayne

  11. Adam Jacobs says:

    Hello Wayne.

    I’m grateful for your engaging here. I have a couple of questions for you, if you don’t mind.

    You talk about “completed trials”. According to clinicaltrials.gov, Burzynski has registered 61 trials of ANPs, of which only one is complete.

    Is that information accurate, or have more trials than that now been completed? If more have been completed, then you’d be doing Dr B a big favour if you remind him of the importance of updating the clinicaltrials.gov records.

    Are you able to put a figure on the number of trials that have been completed?

    As someone who works in the publication of clinical trials, I do appreciate that it’s not realistic to expect to publish the results of a trial the day after the trial completes. But we would generally expect to see something within a year or so of completion.

    Can you say when the trials completed? Can you estimate when the publications will be submitted to the journals?

    Many thanks in advance for taking the time to respond.

  12. John says:

    I am no scientist so there is one aspect of this that I just cannot understand. If Dr Burzynski is trying to get these results published and prove the efficacy of this treatment but has not yet completed the trials or achieved proven significant and replicable results, then how has he been using the treatment for 35 years. Surely that demonstrates a fairly callous disregard for any kind of testing if after so long without significant conclusions or the ability to “put the drug on the market” it would be extremely irresponsible to offer the treatment.

    But as I say, I’m not a scientist.

  13. I am aware of the Neuro oncology abstracts.

    It is worth noting that NeuroOncology is not a high impact journal in the field of oncology, nor particularly generally.

    It is also worth noting that the threshold for conference or poster abstract publication is far, far lower than that for peer reviewed journals. They are another poor substitute for actual articles.

    It’s also worthy of note that the sheer length of time it has taken the clinic to get to a position of being ready to publish is decidedly odd. It does look a lot like their “stopping rule” for recruitment was effectively analyse the data and if it’s favourable stop recruitment if not we will do a few more (which is also a trick common to big pharma in some of their drug studies).

    Basically just carry on until you get the result you want.

  14. Adam Jacobs says:

    analyse the data and if it’s favourable stop recruitment if not we will do a few more (which is also a trick common to big pharma in some of their drug studies).

    Forgive me for being a little off the main topic here, Keir, but I have to pick you up on that. Any regulated trials done by big pharma will have very precisely defined stopping rules, in which the statistical implications of stopping early when you have good results will be rigorously taken into account. You really can’t just “make it up as you go along” in big pharma, the way that Burzynski seems to.

    I suspect you’ve been reading Bad Pharma, haven’t you? Don’t necessarily believe everything you read there! What Goldacre said about stopping trials early was quite simply wrong, as I’ve previously blogged about.

  15. jcmacc says:

    Wayne Dolcefino says:

    “One other note, I notice people seem to have trouble with my comments about the vast majority of patients are not involved in clinical trials at the clinic. They are not. I am not sure how I can be any clearer.”

    This is very clear and, if true, very problematic. This means that Burzynski would be selling patients unapproved therapies outside a trial which is totally illegal. This is true both for “antineoplastons” as well as the convential drugs he is using off label i.e. in contexts not approved by the FDA.

    In defending Burzynski against his mistreatment of the clinical trial process, this – taken at face value – is an admission of far greater criminality.

    The only defence would be that Burzynski is treating his patients with approved drugs for the correct indication. That destroys any claim to be in any way different to a standard, genuine oncologist.

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