While I’m using my blog as an announcement platform today, I would be remiss not to mention that tomorrow is Dr. Stanislaw Burzynski’s birthday, and the Skeptics for the Protection of Cancer Patients are still raising money for St. Jude’s Children’s Hospital in order to try to get Dr. Burzynski to do something good for cancer patients for a change. The beauty of it is that, even if Burzynski declines, as is likely, there’ll still be a nice big donation to a real cancer center that does real good for children with cancer, which is in marked contrast to Burzynski. Harriet Hall has joined in the campaign and is auctioning off a beautiful, hand-knit afghan, knitted by the SkepDoc herself, the proceeds to go to the campaign. If you want to bid on it, it’s on Ebay and can be found here. If you don’t want an afghan (although why you wouldn’t, I have no idea), you can donate to the campaign here.
While I’m mentioning Dr. Burzynski again, a reader named W. Kevin Vicklund pointed something very interesting out in the comments of this post. Basically, the Burzynski Clinic has updated its webpage on clinical trials, and the new language is quite different from the old language:
[Introduction to]What are Clinical Trials?
Clinical trials (also clinical research, clinical studies) are research studies to determine whether experimental treatments, or new ways of using known therapies, are safe and effective. Carefully conducted clinical trials are necessary to find treatments that work in people and ways to improve health.
There are four phases of clinical trials in cancer treatment:
Phase I trials: to determine the safety of a new treatment
Phase II trials: to determine whether a certain kind of cancer responds to a new treatment
Phase III trials: to verify whether a new treatment is better than standard treatment
Phase IV trials: to find more specific information about a new treatment that has been already approved for use in patients
[Antineoplastons - Subject of Clinical Trials
Antineoplaston treatment is an experimental therapy offered by the Burzynski Clinic, currently available only within clinical trials.
Currently, there is 1 open clinical trial on Antineoplastons (as of January 2012). The clinical trial is registered with the FDA and result of the trial is reported to the FDA on an annual basis.
Read more about Antineoplaston Therapy]
Clinical trials conducted in our Clinic are FDA approved protocols. A protocol determines what will be done in a clinical trial and why. It outlines how many patients will participate in a clinical trial, type and frequency of medical testing, treatment plan, monitoring requirements and the evaluation plan. [Our staff physicians strictly follow the protocol and submit periodical reports on the progress of the study for FDA evaluation.]
Enrollment in Clinical Trials
The clinical trials encompass a variety of brain tumors in both children and adults. [Over the last ten years more than 2,000 patients have participated in the clinical trials on Antineoplastons.] Only patients eligible to enroll in clinical trials may receive Antineoplaston treatment under the study. [Ineligible patients may receive approval to enroll, from the FDA on an individual basis.]
To find out if you qualify for enrollment in clinical trials, please contact our Cancer Information Specialist.
[The list of open clinical trials is available at Clinicaltrials.gov (the FDA official clinical trials data bank). For the most recent information please contact the Burzynski Clinic directly.
The official reports on the progress of the clinical trials on Antineoplastons are presented regularly by Dr. Burzynski and his associates at various medical symposia and conferences. Mid-term reports from the clinical research are regularly published in peer-reviewed journals and subject-related scientific books.
View the most recent scientific publications.
Clinical Trials: Antineoplastons in Treatment of Brainstem Glioma
Orphan Drug designation
In September 2004, the FDA granted Orphan Drug designation for Antineoplastons A10 and AS2-1 for the treatment of Brainstem Glioma. The Orphan Drug designation has been extended to all Gliomas
The FDA's orphan drug program is intended to encourage research, development and approval of products for treatment of diseases that affect fewer than 200,000 patients in the United States per year and provide a significant therapeutic advantage over existing treatments.
Orphan drug designation enables the Burzynski Research Institute to apply for assistance from the Office of Orphan Product Development in guiding the drug through the regulatory approval process.
Phase III clinical trial - Brainstem Glioma
The protocol for the Phase III trials is ready. Phase III trials are expected to start in 2012.
Last Update: January 2012]
Rather interesting, don’t you think? At least, I thought so, which is why I mentioned it and reproduced Kevin’s comment in full. It looks as though in 2013 Burzynski has scrubbed mention of the infamous phase III clinical trial and the use of sodium phenylbutyrate, which, as I have pointed out, is what one antineoplaston is. Overall, the new Burzynski clinical trials page is much more stripped down, doesn’t mention a list of open clinical trials (mainly because, as far as I can tell, few, if any, of the more than 60 clinical trials Burzynski has registered at ClinicalTrials.gov are currently open to accrual; certainly the phase III trial is not). One wonders whether this change in the Burzynski Clinic’s clinical trials page means that the phase III trial is, as they say, kaput. Of course, I always suspected that it would never open anyway and was simply a way for Burzynski to make it look to patients as though the FDA has enough confidence in antineoplastons as cancer therapy to let him do a clinical trial. It all makes me wonder once again how Burzynski has gotten away with his shadow clinical trials game for around 20 years now and with administering a therapy with no convincing evidence of efficacy against the tumors he’s treating for 35 years.
If ever there was a place that desperately needed some light shined into its dark recesses, it’s the Burzynski Clinic.