By Keir Liddle
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?