Following up some links from the coverage of the Burzynski matter. From David Colquhoun, an item from the National Council Against Health Fraud newsletter March/April 1997:
The trial of Stanislaw Burzynski for cancer fraud ended in a hung jury (6-6)
on March 4. CBS’s 48 Hours‘ interviews of jurors told the tale as to why
they couldn’t agree. Clearly, the jurors agreed that Burzynski was guilty as
charged of violating court orders not to distribute his unapproved
“Antineoplastons” in interstate commerce, but the fact that some desperate
cancer patients believed Burzynski’s remedy was keeping them alive (or, at
least, was keeping their hope for recovery alive) made the case too emotional a matter for them to convict him of his crimes. One juror who was interviewed admitted that she had disregarded the judge’s instructions to ignore such issues.
The CBS reporter confronted Burzynski with the calculation that, based upon his fee system and patient load, his annual income would be $20 million. Burzynski concurred but said that not all of his patients paid their bills. Burzynski claims that his medicine is quite costly to produce. Cancer
researcher and NCAHF board member, Saul Green, PhD, pointed to prices in a catalog showing that a bottle of medicine cost Burzynski 80 cents.
The Burzynski trial was stereotypical. Supporters paraded with placards
extolling the doctor and his cure, while the media reporter focused on a few
individuals who apparently do have cancer but whose survival is no more than one would expect from any group of patients. The prosecution is shown as dealing with technical points of law, while the doctor and his patients are “real people.”
It is classical deception by illusion. Viewers have no way of knowing if the
demonstrators are really cancer patients. A study of a laetrile rally in 1978
found having cancer did not predict participation in an anti-FDA rally; rather being against fluoridation, disliking MDs, liking chiropractors, and shopping in health food stores were the determinants. Viewers have no way of evaluating the real medical conditions of the patients shown. Most are not even aware of just how normal a cancer patient can look and feel even in advanced stages of the disease. And, no one knows the proportion of failures among the large number of patients who Burzynski has treated over the two decades he has promoted his remedy.
Trial by placard waving emotion is a form of mob rule. More and more it
seems like society is letting emotion overrule the sound judgment of carefully considered law.
I had assumed that this trial hadn’t undergone ethical scrutiny, because I could not see how any committee could agree that it was ethical to charge someone enormous sums of money to take part in a research
project in which there was no guarantee of benefit. I suspect that many people would pay up if they felt they’d exhausted all other options. But this doesn’t mean it’s right.I was surprised, then, to discover that the Burzynski trial had undergone review by an Institutional Review Board (IRB – the US term for an ethics committee). A letter describing the FDA’s review of the relevant IRB is available on the web. It concludes that “the IRB did not adhere to the applicable statutory requirements and FDA regulations governing the protection of human subjects.” There’s a detailed exposition of the failings of the Burzynski Institute IRB, but no mention of fees charged to patients. So I followed a few more links and came to a US government site that described regulatory guidelines for ethics committees, which had a specific section on Charging for Investigational Products. It seems the practice of passing on research costs to research participants is allowed in the US system.
Well don’t I feel proud of the US system.