By Les Ogilvie
Throughout The 21st Floor coverage of the Burzynski controversy/saga we have concentrated on criticism of the idea of antineoplastons. Antineoplastons are what Dr Stanislaw Burzynski is most famous for – a mix of human metabolites (Dr Burzynski often calls them “peptides”, but they’re not) which Burzynski believes naturally exhibit anti-cancer properties. Indeed, most of Burzynski’s flirtations with mass media have concentrated on the “antineoplaston” story. A fawning, excruciatingly one-sided, movie has been produced – “Burzynski the Movie: Cancer is Serious Business” – which tells the story of Burzynski’s discovery of “antineoplastons” and attempts by the establishment (principally, the FDA) to suppress this “cancer cure”. Mainstream news sources have carried stories about patients desperate to raise money to go for pioneering “antineoplaston” treatment at Burzynski’s clinic in the US. And high profile spokesmen for the alternative medicine industry, such as NaturalNews’ Mike “Mad as a Basket of Smashed Crabs” Adams and Joseph Mercola, have climbed over one another to fellate Burzynski over his “natural” cancer cure and stubborn refusal to give in to pressure from The Man.
Accordingly, we have allowed much of our focus to fall on the issue of antineoplastons. However, it is starting to appear very much as if these antineoplastons are something of a red herring.
The real story emerging from analysis of the Burzynski clinic (after their pseudo-legal attack dog Marc Stevens opened up a Pandora’s Box of scrutiny) centers on their off-label use of conventional chemo- and immuno-therapy. The term “off-label” refers to the use of a drug in conditions under which it is has not necessarily demonstrated efficacy. For example, a drug’s mechanism of action may be relevant to the physiology of more than one disease, and therefore we might have cause to believe a drug will be effective in conditions that it has not officially been tested for. However, such use is subject to regulation. Practitioners must, for example, ensure their patients are fully aware of the off-label nature of the medication and they must disclose forseeable side effects.
It is precisely this kind of “off-label” prescribing that has brought Burzynski’s clinic under the cosh of the Texas Medical Board, who are investigating the use of extremely conventional, extremely “Big Pharma”, anti-cancer agents in his practise. Mentioned in the report are erlotinib (Genetech, OSI Pharmaceuticals and Roche), dasatinib (BMS), vorinostat (Merck), sorafenib (Bayer), and capecitabine (Roche). With the exception of capecitabine and vorinostat (which are old-style chemotherapy) all of these treatments are what are called “targeted drugs”. Basically, a targeted drug is a drug which inhibits a particular protein which has known activity (usually aberrant activity) contributing towards a particular kind of cancer. This is a useful technique, because it avoids the large scale disruption to important biochemical processes that are so characteristic of old-style chemotherapy. It also goes some way to addressing the problem of the unbelievable complexity of cancer. For example, the permutations of cellular mistakes that have led to cancer can vary from patient to patient. If we can test a patient to get an idea of exactly what cellular processes have gone awry in their specific case, we can then, hopefully, administer drugs which target only these processes. This is “targeted therapy” and may well be the future of cancer treatment.
When Burzynski talks about “Personalised Gene Targeted Therapy” and “Customized Treatment for Over 50 Types of Malignancies” on his website, forget the so-called “antineoplastons”, it’s this use of conventional cancer drugs that he’s referring to. A fact that has been confirmed to Dr David Gorski by the clinic’s own Renee Trimble as detailed in his excellent, must-read, investigation.
Well, so what?
The problem is, to quote Dr Gorski, that Burzynski is using a haphazard “everything but the kitchen sink” approach to this treatment. He screens his patients for pro-cancer entities, just as in conventional targeted therapy, and then looks for drugs that work on these entities. Even if those drugs have never been approved for the particular kind of cancer being treated. What’s more, he appears to prescribe untested cocktails of targeted therapies with little concern for drug interactions or side-effects, and with incompetent and uninterpretable analyses of his “results”. It’s a dangerous game.
So, what of “antineoplastons”?
Another drug mentioned in the Texas Medical Board report may hint at the answer. Sodium Phenylbutyrate (Medicis Pharmaceutical) is a conventional “orphan drug”, intended principally for the treatment of urea cycle disorders. Interestingly, it is metabolised in the liver to form phenylacetate which is subsequently detoxified to produce phenylacetyl glutamine. At the Burzynski clinic, a mixture of phenylacetate and phenylacetyl glutamine is known as “antineoplaston AS2-1”. Further intrigue is provided by the news that the clinic has referred to sodium phenylbutyrate as a “pro-drug” for antineoplaston therapy. So, it would appear that Burzynski is prescribing his patients off-label sodium phenylbutyrate, and relying on this drug’s metabolites to support his claim that patients have been treated with “antineoplaston AS2-1”. Curiouser and curiouser.
What’s more, the possibility that phenylacetate may have anti-cancer properties has been mooted since 1959, when Burzynski was only 16 (scant evidence to support this idea has accumulated in the intervening years). So it is incorrect to claim that Burzynski “discovered” his antineoplastons, they were already under investigation while he was still in school. Moreover, it is also incorrect to claim that such treatment is not chemotherapy. If it worked for cancer (and evidence that it does so is very thin on the ground) it would almost certainly be as a result of its potential to act as a large-scale inhibitor of DNA transcription (i.e. not a targeted drug).
Would it be cynical to suggest that Dr Burzynski’s business model relies on prescribing a pot-pourri of off-label conventional drugs, while disingenuously marketing himself as a maverick medical genius whose revolutionary discovery (in reality a conventional medicine with a fancy new name) is being suppressed by the establishment? That the “natural”, “side-effect free”, cause-celebre-of-the-alternative-medicine-community, antineoplastons are little more than smoke and mirrors?
The case of Dr Stanislaw Burzynski is a strange one indeed.
Essential reading: Dr. Stanislaw Burzynski, antineoplastons, and the selling of an orphan drug as a cancer cure – Dr David Gorski, Science Based Medicine
Dr. Stanislaw Burzynski’s “personalized gene-targeted cancer therapy”: Can he do what he claims for cancer? – Dr David Gorski, Science Based Medicine