As we approach the release date for Eric Merola’s second propaganda film dubbed “Burzynski II: This time it’s peer-reviewed“, I have to wonder what the game plan is. As far as I can see there are not many outcomes towards which Slippery Stan might be working. The options appear to be FDA approval, going alternative or going South.
I think he is headed South.
Let me run through my reasoning.
Why it matters
Any idiot can claim to cure cancer. Cancer patients are, by and large, desperate and expecting to die. If they do die, it’s not a surprise. If they don’t, they can easily be persuaded to credit their survival to whatever snake oil they tried last. Cancer outcomes are measured in terms of prognosis and survival – but prognosis is notoriously inaccurate in early diagnosis. If doctors give someone a few months to live and they last two years, it’s likely that the doctors just didn’t have enough data on that patient’s disease yet, rather than some miracle cure having extended life.
This is an important truth. Purported cancer cures run the gamut from dangerous (black salve) through implausible and utterly improbable (homeopathy) to the mass of unproven and generally thoroughly discredited “alternative” therapies such as Hoxsey, Gerson, Clark’s Zapper, detox and so on.
The only credibly identified way to separate exploitative bullshit and delusion, from effective emergent therapies, is the scientific method. Trials, tests, independent replication, and open debate.
Failure to engage fully with the scientific community, and especially with those who investigate a treatment skeptically, is a red flag for quackery. And refusal to do so is close to being a 100% reliable litmus test for quackery.
Most of the theatre of trials we’ve seen to date looks on the face of it as if it’s intended to get FDA approval for antineoplastons – but scratch the surface and that interpretation looks less likely.
In order to get approval you have to show a solid in vitro effect at usable doses, a reasonably unambiguous effect in humans i phase II trials, and a concrete benefit over the existing standard of care in phase III trials. All of these require publication in peer-reviewed journals.
Burzynski has, as his fans point out, published a few papers. Most of these are conference reports and other low grade material that is not peer reviewed. A few people have also published some cautiously positive results from early tests, notably in Japan. But the output is staggeringly thin for 35 years of supposedly near-continuous investigation.
Does Burzynski want FDA approval?
An alternative interpretation is that the clinical trials have been a fig leaf to allow Burzynski to continue to market his treatment in the absence of approval, an end-run around the consent decree which allowed him to keep practising when he was found guilty of selling unapproved medicines across state lines.
I believe the latter, because form everything I have seen it appears to me that Stanislaw Burzynski does not care if the FDA approves his antineoplastons. As far as he is concerned the jury is in: they work, he believes they work, so any independent approval is an irrelevance. I am pretty convinced of this.
He is wrong, of course. Not necessarily about the antineoplastons (though it’s likely he is wrong about those) but he is wrong about the idea that approval, which is basically the rubber stamp which says you have convinced people who are not vested n the product, is irrelevant. There is a massive brouhaha right now about the release of trial data by pharmaceutical companies, the alltrials initiative championed by Ben Goldacre among others. By cherry-picking the evidence you publish, you will almost always overstate the benefit of your treatment.
But more than that: if he gets FDA approval, he will no longer be the “brave maverick”. The secret will be out, other people will be able to probe the soft underbelly of his treatment regime and maybe even use better science and better knowledge to improve it. I don’t think he is up for that. In his mind, he seems to be the lone genius whose understanding cannot be approached by mere mortals – I think he has been reading his own PR for so long that this inevitable consequence of being surrounded by yes-men has surely set in. I do not think he can handle the cognitive dissonance that would result from approval, which would be followed by genuine tests of his treatments against other drugs, and would establish not only whether it works or not, but whether it works better than other treatments. This last looks, on the face of it, to be extremely unlikely. It also seems unlikely that his supposed mechanism is in fact the right one.
It’s my view that if “antineoplastons” were approved, the result would be in short order the discovery that Burzynski has been playing science for 35 years with only limited understanding, due in large part to his failure to follow the publish-and-collaborate model that has been the core of most genuine scientific advance in the last century.
If your main concern is to do business and “heal” people without all the tiresome business of evidence and regulation, the world of “alternative” medicine is the way to go. You can make the most extraordinary claims and as long as you move every few years to stay ahead of state health boards you can keep in business almost indefinitely.
You can also use the “bait and switch” tactics beloved of supplement purveyors, where you describe miracle cures and discuss the terrible effects of “toxins” in one place, and sell remedies in another, pretending that you are not formally making these curative claims at point of sale.
I don’t think Slippery Stan is going that way because most of his reputation seems to depend on administering standard cancer therapies (i.e. chemo) and pretending that he is doing it in a s”special” way. That requires a medical license, and that in turn pretty much precludes “going altie”.
Tijuana in Mexico has two things going for it as far as Slippery Stan is concerned: first, it’s close to the border and already has a thriving alternative health tourism market; and second, it has notoriously lax regulation (although they did eventually shut Hulda Clark down). In Tijuana you can offer amygdalin, Gerson, Hoxsey or any one of a number of quack cancer “cures” and get away with it as long as you’re not actively killing people (other than by deluding them into thinking that drinking juiced vegetables can cure cancer).
Commercial property is relatively cheap and the climate is nice.
It’s the perfect place for a
quack charlatan brave maverick doctor to hang up his shingle.
And I believe that the upcoming Burzynski II is little more than a press release informing the world of this. Screw the FDA, if you want your cancer cured come to Doctor Stan’s
Snake Oil Gene Targeted Cancer Therapy Emporium and pay the nurse on the way in.
It is not clear how someone with such a visceral reaction against any form of critical questioning, could ever handle the process of scientific debate. Can you imaging Burzynsi at a meeting of oncologists, calmly fielding penetrating questions about the details of his work and his outcomes? All the evidence we have to date suggests that any questioning is interpreted as wanting people to die and hating patients for being “cured”. Anything that interferes with the process of belief appears not to be acceptable to him.
So, for my money, Burzynski is headed for the border. You saw it here first (maybe).