Saturday, 17 December 2011

Time for Pressure on Media Promoting and FDA Facilitating the Burzynski Clinic Quack-Scam

The criticism of the close to fraudulent cancer treatment scam operated by the Burzynski Clinic that I have covered in some earlier posts (here, here), due to its attempt to silence public criticism through legal threats and general bullying and harassment, needs to shift focus. We know that what the clinic does is a confidence scam of a classic type: The necessary confidence-part is secured by conveying an impression of offering a "last hope" experimental treatment to desperate cancer patients and their close ones (while what one is actually offering is a procedure that has been experimental for three decades and not been shown to have any sort of effect in spite of all these years of research devoted to that end). The actual scam is the appallingly high price charged for the FDA-approved chemotherapy treatment that has to accompany the experimental one, lest the clinic would be clearly guilty of severe malpractice. But, as I said, this is now well-known and need not be further supported, besides mentioning some additional details that have surfaced lately, such as the disastrous track-record of the Burzynski clinic's clinical trials and the piquant fact that those who want to make donations to support the clinic's research are asked to wire the money directly not to the clinic or its attached research center, but to the dear Dr. Burzynski himself, and the fact that said Dr. Burzynski is under investigation for rather serious misconduct by the Texas Medical Board.

But let's not once again lose ourselves in what we already know, but ask the question: what makes the scam possible? One, of course, is the combination of the quite understandable desperation of anyone who has been struck by the information that one or one of one's close ones has incurable, terminal cancer – this is the source of there being a prey for the Burzynski vulture-strategy. Second, equally obvious, the complete  ruthlessness of the clinic itself and , at least, its leadership and its medical and management staff. But the fact is that that the clinic is extended ample help and support from two directions that are not equally obvious or expected.

One of these is "old" mass media. What started the whole story this round was an article in the UK newspaper The Observer, promoting a charity call for financial support of a family that wanted to take their sick child into the Burzynski program, but couldn't afford it (no wonder!). It was blog posts (primarily this one and this one) reacting to the fact that an otherwise respectable newspaper in this way made itself into a mindless megaphone of a quack-scam that attracted the wrath of the Burzynski Clinic, eventually leading to the ensuing threats and harassment. Later, it has been discovered, that the very BBC choose to publish a more or less similar item. Quite recently, The Evening Standard (also the UK) made a rather similar publication, wording its article carefully to make the facts about the Burzynski treatment look dubious and inconsequential by placing the word 'unproven' last in the article and surrounding it with square quote-marks (thus implicitly conveying the message: 'that's the establishment using fancy words to hide the fact that they don't care about seriously ill children'). Representatives of all publishers have defended the publication of their articles (here, here and here), but seem not to understand what they have been doing – which is making themselves into marketing tools of the confidence scam of the Burzynski Clinic for the prospect of attracting a few more readers. They all refer to a "human interest" reason for publication, but this falls apart as soon as one sees through the shallow, shiny coating that makes the Burzynski Clinic remind of a respectable health care institution at first glance. This is simply bad news-evaluation, poor research and bad publication judgement. Unless, of course, there are deals under the table that would at least make the publication make short-sighted financial sense. In either case, I fully concur with Josephine Jones' conclusion that the publications are immoral.

The other source of support comes from the U.S. Food and Drug Administration, FDA. This was a theme of the criticism that was pursued by Oxford University neurolopsychology professor and popular author Dorothy Bishop early on and which I mentioned in my first post on Burzynski. With all the threats and harassment against bloggers, however, it sadly disappeared as a major theme in the discussion. For, this is a fact: one thing that makes the Burzynski Clinic scam possible to run within the limits of the law is the fact that FDA has been continuously granting the clinic permission to run clinical trials for several decades. This despite the set-up of the scam operation, where these trials are systematically exploited to press enormous amounts of money off of desperate and vulnerable people. There are three very good reasons for why this should make the FDA retract all trial permissions. 

First, one may plausibly argue that what the Burzynski Clinic does is to use the hugely elevated charge for regular chemotherapy to cover the costs of the clinical trials, which means that what people are in fact paying for is to be allowed to participate in experiments with unproven procedures. But this goes against all minimally decent research ethical standards. When a patient participates in a clinical trial, it is the the patient who is doing the clinic running the trial a service, not the other way around. If anyone should be payed anything, it is the patient who should receive and the clinic that should give.

Second, the confidence scam is by itself reason enough to withdraw permissions. Someone may try to argue that, for a private health care institution, it is not wrong or unreasonable to cover costs of research by distributing them in the form of a price increase on offered services (that's a bit like viewing research as a part of the overhead). However, in the case of the Burzynski Clinic, this argument is unavailable for two reasons. One, the clinic offers but two services: regular chemotherapy on its own, or chemotherapy plus the experimental procedure, and it is the price of the latter that is elevated. Two, the clinic's marketing shows that in reality the research and the regular clinical practice cannot be separated. The Burzynski Clinic has but one service on offer: regular and approved chemotherapy with add-on of an experimental procedure. From whatever side one looks, this is a clinical trial, and that is what the clinic charges for.

Third, the track-record of both the past research of the clinic and the scientific publication of Dr. Burzynski himself is, in combination, a rather serious reason for doubting both the scientific basis for viewing the research as defensible in the first place, and the competence of the Burzynski Clinic team to conduct it. Add to this the investigation of the Texas medical Board mentioned above, and you can add reason to doubt the scientific, medical and ethical integrity of the research leader.

If the FDA was to decide to review the entirety of this complex of reasons, I'm quite sure that they would indeed find cause to revoke the permissions for conducting clinical trials granted to the Burzynski Clinic. And if not that, so at least reasons for changing some of its regulation so that a decision to revoke could indeed be supported. In effect, there are very good reasons to pressure the FDA on this point. Not being a US citizen, I myself do not feel well placed to figure out the best strategy for doing that in an effective manner (petitions? open letters? formal complaints?....), but if someone better placed takes an initiative, I would be more than happy to get on the wagon!