Skeptical activism has several simultaneous goals - to educate skeptics to improve their expertise in critical thinking and the details of specific pseudosciences and uncritical claims, to educate the general public about science and skepticism, and to take specific action to protect consumers, fight against fraudsters, lobby for better regulation, and other good works. The latter goal is often the most difficult, but has the potential of being the most immediately satisfying.
The skeptical movement's social media infrastructure allows us to mobilize tens of thousands of critical thinkers to apply public pressure where necessary - to defend from attacks on free speech, to focus attention on a particular scoundrel, or to pressure politicians into doing the right thing. While such activity is a constant background in skeptical activism, there are moments when opportunities arise for a focused concerted effort. I believe we are at a critical point of one such opportunity.
Stanislaw Burzynski has been exploiting desperate cancer patients for 37 years with his dubious "antineoplaston" treatment. Why his treatment is dubious has been well covered by David Gorski in multiple posts at Science-Based Medicine. Essentially Burzynski is offering unapproved chemotherapy for cancer patients, claiming that it is "natural" and that he is curing cancer patients who are not responding to standard treatment. He has also moved into the "personalized cancer treatment" realm.
His claims are scandalously evidence-free, and have certainly not met the threshold of scientific acceptance or FDA approval. It is amazing that he has been able to get away with this for decades. In the late 1990s the FDA was going after Burzynski for using an unapproved drug but for some mysterious reason decided not only to back off but to give Burzynski a way to keep selling is bogus treatment to cancer patients - in the guise of clinical trials.
Burzynski still charges patients tens of thousands of dollars for his treatment, and he has failed to publish even a single phase II trial (which is a preliminary clinical trial), let alone a full phase II trial (required for FDA approval). It seems he is just going through the motions of clinical research, just so he can keep charging desperate patients for his unproven drug.
From time to time Burzynski gets on the radar of regulators, and has the minor inconvenience of having to defend himself, but always manages to scurry away. There is never the sustained political will to take him down. Perhaps we have a window of opportunity to finally change that.
Last month on this blog Robert Blaskiewicz reported that the FDA has completed a recent inspection of Burzynski's clinic and clinical trials, including the IRB that is supposed to oversee his trials in order to protect the right of subjects. They found numerous egregious violations, including not following the research protocols, failing to report adverse events, and destroying original data such as MRI scans. The FDA charged that Burzynski, ""failed to protect the rights, safety, and welfare of subjects under your care."
This comes at the same time the USA today has published a scathing investigative report on Burzynski.
Burzynski has survived partly because over the years there are patients who believe that Burzynski has saved them. This is common for dubious clinics - some patients are going to get better despite the treatment, mostly because they also received standard care. The survivors can be mobilized to defend Burzynski whenever he gets into legal trouble. Those patients who die under Burzynski's ministrations are no longer around to provide balance.
Now hear comes the call to action - it is us skeptics who have to speak for the dead, to speak for those who may have survived but who were harmed by the false claims and false hope sold at high price by Burzynski, and to speak for all those future patients who will, in their desperation, succumb to the siren song of the gurus.
If you are a US citizen, then go to thehoustoncancerquack.com. There you will find detailed instructions for contacting your representative or senator to demand congressional investigation into Burzynski and his clinic.
Robert Blaskiewicz, who is heading this effort, also has this update:
"First, when you send your materials in to your representatives, you may want to send them to their DISTRICT offices. Security on Capitol Hill is tight, and anthrax screenings may delay deliveries significantly. Alternately, you may fax your documents to them (though in that case you might want to limit the FDA documents you send to only the most recent).
Second, we have found that there are a number of committees and caucuses relevant to the research and health issues we want investigated. Please see if you have representatives on the House Cancer Caucus (co-chaired by Steve Israel of New York and Lois Capps of New York), the Senate Cancer Coalition (chaired by Dianne Feinstein), and especially the Childhood Cancer Caucus (co-chaired by Michael McCaul of Texas and Chris Van Hollen of Maryland). It is important to ask members to support more urgent research into rare childhood brain tumors. As it stands, there are not a lot of good treatments for these tumors, and we want desperate parents to feel like they have better options than antineoplaston trials.
Lastly, and this is crucial, we have set up a feedback form for you to report back on your progress. We are gathering this information so that we can run the most efficient campaign possible."
For those outside the US you can still support the effort by spreading the word and focusing attention on Burzynski and this effort.
We will keep you updated on this campaign. On the evidence, this case appears open-and-shut. Burzynski if violating multiple ethical principles, his treatments are implausible and he has been using them for decades without doing proper research, and now he is charging patients to enter his dubious clinical trials. It's a dangerous farce. We need the political pressure to finally have regulatory agencies to their job, or be embarrassed by their failure.
Steven Novella, M.D. is the JREF's Senior Fellow and Director of the JREF’s Science-Based Medicine project.