Wednesday, 30 November 2011

Lame Response from the Burzynski Clinic

Yesterday, the Burzynski Clinic issued a press release in response to the massive twitter (1, 2) blog and eventually old media coverage of how an alleged representative of the clinic bullied and threatened bloggers exposing the highly unethical practices of the clinic (see my former post). What the clinic does is to charge huge sums of money for people to access what is described on the clinic's website as "tomorrow's cancer treatment today" (duh!), which basically consists of state of the art treatment of chemo-/radiation-therapy (available at much cheaper cost at other clinics) plus Dr. Burzynski's own little discovery, antineoplaston, that has remained in the phase II of clinical trial, where the aim is to demonstrate any sort of benign effect, for several decades with zero results. One very limited version of the treatment (for Brainstem Glioma, a very malign and inoperable form of cancer) has been approved by the FDA for studies in phase III, going beyond this limit – planned to start this year according to the clinic's website. This approval has been issued under a special so-called orphan drug statute, meaning that the FDA considers there to be an extra important reason to allow research due to the rareness and severity of the disease combined with the fact that there is no existing very efficient treatment. There are no details on the arms of the trial, but one may assume that since there is some efficiency of chemo- and radiotherapy also regarding Gliomas, the setup will be such therapies by themselves compared to the same plus Burzynski's own invention. Any other arrangement would be a scandal.

In any case, the deeply unethical and very close to fraudulent practice of conveying to devastated people hit by the tragic information that they or one of their loved ones suffer from incurable cancer that they can access some sort of miracle cure if only they empty their savings accounts in the greedy lap of the Burzynski Clinic has to stop. It is highly problematic already in a phase II trial, but it is completely unacceptable and against all research ethical standards in a phase III trial. In fact, if anyone should be paying anyone anything it is the Burzynski clinic that should pay trial participants for their service to lend out their already heavily burdened bodies and minds to help investigate a procedure that as yet has shown no clinical effect whatsoever. And if FDA regulation allows such practice in phase III, it has to change, effected immediately, since it is a loophole for manipulating and conning seriously ill and very vulnerable people.

Of course, as always in science, caution should be exercised in predicting results of forthcoming studies. Basically, we'll see what the phase III trial eventually shows. But if this summary of the history of research on Dr. Burzynski's research is to be believed, there is not much cause for optimism. But, hey, I haven't said anything about the press release yet, so let's go there.

The most important message of the press release is that the clinic clearly distances itself from the content of the messages sent to bloggers by Marc Stephens and stating that said Stephens is not a representative of the clinic, but....:

So, Stephens was indeed hired by the clinic to do the job that he did, he just did it so bad it is even fascinating. To see this, we go to the next stage of the message when the clinic starts to address how it will now proceed in relation to said bloggers with regard to said dissemination of allegedly false information:

Of these, points A and B are inconsequential for the matter at hand (although it may be noted that point A is a lie, search for ANTINEOPLASTON A 10 here and see for yourself). They don't affect at all to what extent the Burzynski clinic is manipulating vulnerable people to pay out hundreds of thousands of US dollars for a treatment they could have received much cheaper elsewhere and with an add on with no proven effect. Tastelessly enough, in the press release is included a report on how a single, named patient who is in one of these phase II trials is doing. I will not name her, and I find it rather inappropriate of the clinic to do so. In any case, the statement that she is improving because of Dr. Burzynski's antineoplaston treatment lacks all foundation, since antineoplaston has not yet been demonstrated to have any effect. The patient's promising form is thus most probably the effect of the radio-/chemo-therapy administered in addition to the antineoplaston addition. In any case, a phase II trial cannot prove otherwise, no matter how many patients are included.

So, what about point C, then? This indeed is of some relevance, since scientific publication is the sign that a researcher has made progress in a way that is condoned by independent scientific specialists in the area. Well, after 2006, the list provided in the press release states 1-3 articles a year up to 2010 (when there is one). None for 2011, apparently. But anyway, that's pretty OK, isn't it? Well, actually not, according to this look into what sort of publications these are. In short, the publication record of Dr. Burzynski's research isn't worth zilch. Prior to 2007 it is either published in journals with no impact factor at all (meaning not even considered serious enough a scientific journal to be worthy a rank in terms of importance), or a ridiculously low one for a medical journal (meaning that virtually no one pays attention to what is published there). This, in turn, implies that stuff sent to these journals is stuff that no one of the more influential and better journals deems worthy of publication. It may be added, that if there had indeed been some result of a new cancer therapy, that would be material for the most high esteem journals in the world. In addition, these journals turn out to be either fronts for pseudo-science or the works of happy local amateurs.

From 2007, however, there are articles listed from the quite respectable  journal Neuro-Oncology. But..... wait a minute, I may just as well directly quote Jen McCreight, whose analysis I am using:

Burzynski has not published a single paper in this journal. Every single citation is an abstract from a presentation made at a conference. For those of you not in academia, we like to hold conferences where people can present their research and network. However, you’re allowed to present preliminary results that haven’t been published yet. Any scientist can submit abstracts in order to speak at conferences, and if that single paragraph sounds interesting, you get to give a talk. It’s pretty much impossible to judge how legitimate research is from an abstract (or presentation) alone, and some conferences are not competitive at all when it comes to who gets to speak – they have plenty of spaces to accept all presenters. Journals often act as archives for conferences they’re affiliated with, and will list those abstracts.
This means that none of Burzynski’s research from this journal has actually been peer-reviewed by the journal. The fact that he never actually published this data says a lot. Seriously – if you legitimately found something that helped cure cancer, prestigious journals would be tripping over themselves to have you publish in them. The fact that you can’t publish your research anywhere except in the occasional bottom-of-the-barrel shady journal means your research is terrible.
 McCreight in addition rounds off with the observation that there have been several attempts to replicate the promising results of antineoplaston reported by Burzynski, but all have failed.

So, there we are. After 2006-2007, Dr. Burzynski has made numerous presentations at scientific conferences reporting promising results, but no one seems to be able to replicate these. These presentations have indeed been abstracted in the journal Neuro Oncology. However, after some articles in scientifically completely insignificant journals, after 2007 there are no scientific articles reporting Dr. Burzynski's research in print.

In effect, due to the list of publications provided by the press release, the scientific standing of the Burzynski Clinic now actually looks even less impressive than before. In effect, the call for the clinic to immediately shut down its preposterous financial scam has been strengthened. And so has the case for FDA to urgently revise any regulation making such scams possible.