The Burzynski Case: The FDA’s Failure to Prevent Exploitation of Desperate Patients

July 6, 2014

As supporters of CFI are aware, we critically examine not only religion but also pseudoscience.  Some regard these as distinct enterprises with little overlap.  As you might expect, most of us at CFI view things differently. 

Unifying our work is a methodological commitment to reason and evidence, whatever the particular issue under investigation.  Moreover, religion and pseudoscience share certain affinities. Not only does their success depend heavily on the suppression of evidence, fallacious reasoning, and the elevation of personal feelings of certitude over careful empirical inquiry, but religion and pseudoscience can also cause serious harm, both through their influence on public policy and their effects on the lives of individuals.  For example, CFI’s Keep Health Care Safe and Secular Campaign details some of the ways in which both religion and pseudoscience adversely affect health care policy and the treatment received by individual patients. 

And, in some instances, religion and pseudoscience share something else: they are vehicles for exploiting the desperate hopes and fears of the vulnerable. 

To state the obvious, most people do not want to die—at least not just yet—and the fear of an impending death caused by illness will motivate many people to try just about anything that might help them, whether it’s prayer, a saint’s relics, or some concoction thrown together by a peddler of snake oil.  The desperation of patients in these situations is understandable, and given their circumstances, one can hardly hold them culpable of anything but false hope. 

But those who exploit these false hopes, especially when the exploitation is done for financial gain, are blameworthy. Indeed, whether they are cloaked in priest’s vestments or a lab coat, they merit our severest condemnation.

That said, there is one critical difference between the holy man who claims to channel blessings from the spirit world and the fringe physician or scientist who claims to have developed some astonishing cure. We cannot and should not do much to curtail the spirit merchants. Although arguably science has removed  many of the arguments that theologians formerly used to “prove” the existence of God, the core claims of religion are not verifiable or testable. Religion deals with other-worldly matters. For that reason, one of the key foundational principles of the secular state is that government has nothing to do with religion, and if people want to babble on about unseen, undetectable spirits, that’s largely their business, provided that they don’t try to use these messages from the spirit world to guide public policy. (That’s been the problem, hasn’t it?) It’s up to other individuals —critical thinkers who care about the follies of their fellow humans—to point out the imprudence and irrationality of basing key life decisions on “faith” in unverifiable revelations that supposed deities share solely with some self-appointed prophets.

Fringe scientists, though, are in a different position. They claim to be dealing in the natural world, the world in which one can test a hypothesis. Furthermore, as science has become increasingly specialized, isolated laypersons are usually not equipped to challenge the claims of pseudoscientists, at least not the sophisticated ones. With some proper training in critical thinking, any reasonably intelligent person should be able to see through priestcraft, but I can’t very well set up a lab in my basement to test the latest alt-med “breakthrough.”  I need to rely on experts, including the experts employed at taxpayer expense by our regulatory agencies. Part of the mandate of the Food and Drug Administration is to ensure the public is able to base its health care decisions on accurate, scientifically sound information.  If the FDA doesn’t regulate the peddlers of fake cures and ineffective therapies, then these individuals are able to cloak themselves with the aura of scientific respectability.

Which brings me to the case of Stanislaw Burzynski. I’m not going to repeat here what CFI, and its team of scientific and medical advisors has already stated in letters to the FDA and press releases. Suffice it to say that for nearly four decades Burzynski has been promoting an unproven, scientifically unsound cancer therapy. Moreover, although the therapy is sometimes promoted as being “free,” patients  and their families wind up paying tens of thousands of dollars in clinical fees. (David Gorski details some of Burzynski’s tactics in this informative blog post.) It’s not as though the FDA has ignored Burzynski. To the contrary, the agency’s own investigators have cited his clinic for failure to comply with appropriate testing protocols, issuing warning letters to his clinic and, eventually, placing a hold on his mismanaged, unsuccessful, and risky clinical trials. Unfortunately, the agency reversed course recently—probably as a result of political pressure. Not only did the agency decide to allow Burzynski to treat individual cancer patients under a “compassionate use” exemption, but it also allowed him to restart his clinical trials.

The FDA’s actions represent an abandonment of its responsibilities to the public. Again, we all understand why desperate, terminally ill patients might turn to Burzynski and others of his ilk. It’s not the job of these emotionally burdened patients to assess cancer therapies and separate the legitimate ones from the fake ones. That’s the FDA’s job. It’s the FDA’s job to prevent exploitation. It’s the FDA’s job to shut down failures and exploiters like Burzynski. We don’t need a Federal Theological Agency. We do need a Food and Drug Administration that  properly uses its scientific expertise to protect patients.