The #Burzynski hashtag on Twitter has lit up lately following the publication of a letter from the FDA requiring the Burzynski Clinic to cease publicising “antineoplastons” (ANPs) as safe and effective, and using patient testimonials, as the drugs are still investigational and therefore may not be promoted for the indications for which they are currently still under investigation.
The response of the single-purpose shill accounts has been predictable, and is a nice case study in the way quacks respond to criticism and controversy.
The first response was to castigate skeptics for failing to be equally critical of Genentech, also criticised by the FDA. In case it wasn’t obvious, here are some of the reasons that this argument is invalid:
- Problems with other companies in no way undermine the problems with Burzynski’s fraudulent claims.
- Nobody has identified any single-purpose accounts shilling Genentech, whereas there are numerous single-purpose Burzynski shill accounts.
- Genentech has a drug which is FDA approved for certain indications, their problem was promoting for other indications. Burzynski’s antineoplastons are not approved for any indication, they are unproven despite over 30 years of investigation (in reality 30 years of sale, there’s no actual evidence of any type of scientific exploration).
Having failed to prevail re Genentech they switched to a standard smokescreen tactic: ANPs must be safe and effective or the FDA would not have sanctioned a phase 3 trial.
Some of the reasons this argument is invalid:
- The existence of a trial very obviously does not prove that the outcome the trial is designed to test, is true. That is after all the entire point of the trial: if the existence of a Phase 3 trial proved that a drug were safe and effective then there would be no need for the trial in the first place!
- The trial has yet to recrtuit a single participant, according to clinicaltrials.gov.
- None of the Phase 2 trials (60 of them at last count) has ever been published.
Whatever the reason the FDA has allowed Burzynski to register yet another trial despite the massive flaws with his institutional review board and his conspicuous failure to publish any previous trial results, the mere existence of a phase 3 trial absolutely and categorically does not prove anything at all about the safety and/or efficacy of the treatment, the very question the trial is supposedly designed to answer.
After the failure of the first two arguments the shills fell back on their standard ploy of cherry-picking. Specifically, they cited a 1991 letter from an Associate Director at the National Cancer Institiute which says:
Antineoplastons deserve a closer look. It turns out that the agents are well-defined, pure chemical entities. They are relatives of Thalidomide with presumed good CNS penetration. We are workign with DTEP on them. The human brain tumour responses are real.
That was then, this is now. Twenty years later has the “presumed good CNS penetration” and “real” response translated into anything usable? Er, no. This is what NCI currently says about ANPs:
In 1991, the National Cancer Institute (NCI) reviewed some of Dr. Burzynski’s cases and decided to conduct clinical trials on antineoplastons at cancer centers. By August 1995, only 9 patients had enrolled and the clinical trials were closed before being completed. The U. S. Food and Drug Administration (FDA) gave Dr. Burzynski permission to conduct clinical trials of antineoplaston therapy at his own clinic. Ongoing non-randomized clinical trials at the Burzynski clinic continue to study the effect of antineoplastons on cancer.
So the 1991 letter refers to an investigation that was terminated less than five years later due to lack of any promising results. NCI rightly describes the treatment as “experimental” and makes it perfectly clear that nobody other than Burzynski is interested in further testing it. As they say here:
- Antineoplastons are drugs composed of chemical compounds that are naturally present in the urine and blood. They are an experimental cancer therapy that is purported to provide a natural biochemical substance that is excreted and therefore lacking in people with cancer.
- Antineoplastons were first proposed as a possible cancer treatment in 1976.
- Antineoplastons were originally isolated from human urine but are now synthesized from readily available chemicals in the developer’s laboratory.
- Antineoplastons are not approved by the U.S. Food and Drug Administration for the prevention or treatment of any disease.
- No randomized controlled trials showing the effectiveness of antineoplastons have been published in the peer-reviewed scientific literature.
- Antineoplaston side effects can include serious neurologic toxicity.
- Nonrandomized clinical trials investigating the anticancer efficacy of antineoplastons are underway at the developer’s institute.
In fact the evidence suggests that even Burzynski is not actually interested in testing ANPs. He has made up his mind. In his mind, no further tests are needed. The problem is that he is pretty much alone in this view, but is proceeding as if his assumptions are proven.
They aren’t. ANPs are unproven, and that is why the FDA have told Burzynski to stop promoting the treatment as safe and effective, because there is no credible independently verified evidence that they are either.