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.




#1 S.Hill on Monday July 07, 2014 at 10:57am

I’m pleased CFI made a statement about Burzynski. But this post leaves me wondering if you were chastized for it? It sounds like you are defending your statement.

I understand the commonalities of mistaken beliefs from pseudoscience and religion. If CFI stuck to that, I could see more of an appropriate umbrella mission to the organization.

However, CFI spends a great deal of effort advocating for secular rights and freedom from religion (that is not focused on reason and evidence as much as ethics). I do not see a significant overlap between that and applying evidence-focused skepticism because they require different agendas and focus.

While I think it’s excellent to work towards progress in both, CFIs mission and content is muddled (and diluted) by conflating these issues. It may be that supporters of CFI have an interest in both areas but that does not mean the issues themselves should be handled together - some things are better consumed seperately, not on the same plate.

Because I’m interested in science and the public, an entire half of what CFI puts out in content (regarding secular issues) is not really my subject area. When two arms of one org are attempting to keep tabs on such different areas, it’s highly confusing to the audience. We never know what agenda we’re going to get today.

With the schism that has erupted in the past few years over support for social justice issues, new atheism, and the traditional scientific skepticism advocates, it seems incredibly obvious that these two (or three) areas deserve seperate agendas.

I find no problem with the way you separate your journals into the two areas. I’m just seeing the conflation in your mission, the public face of CFI including the various independent branches, your events, and in your web content. I can’t really figure out what you are doing these days. Are you promoting atheism, social justice, freedom from religion, civil rights, or applied skepticism? It’s all messily smooshed together.

Sharon Hill
CFI Science and Technical consultant

#2 Ronald A. Lindsay on Tuesday July 08, 2014 at 12:42pm


Thanks for your thoughtful and well-considered comments. They are so thoughtful and well-considered that I will have to give you a promissory note to respond to them more fully later.

For now, I’ll just say that no CFI supporter specifically criticized our statement on Burzynski. That said, from time-to-time, we do receive criticism from some of our supporters, in some cases not entirely unlike the substance of your observations (but not typically stated as eloquently). For example, if CFI issues a statement on alt-med, especially acupuncture, that usually elicits a handful of emails from self-styled humanists/secularists asking why we’re criticizing a medical therapy, in some cases a medical therapy that they assert has worked for them. Criticism from the skeptic side is more diffuse and sporadic, but the gist of it is that the self-styled skeptics claim they have no interest in church-state separation or religious issues. Moreover, they will sometimes say that if CFI is science-oriented, we should not be working on church-state separation matters or advocating for keeping religion out of public policy, as advocacy on such matters lacks any scientific or empirical foundation. As you put it, these are perceived as “ethical” issues.

I respectfully disagree that they are purely ethical issues, if by “ethical” issues you mean to imply that they are issues with respect to which science, empirical investigation, and evidence-based reasoning play no role. Let me state this as succinctly as possible. Public policy can either be based on messages from a transcendent spirit world, which is how all too many people would have it, or it can be shaped by relevant empirical inquiry and secular reasoning. Consider, for example, programs intended to reduce teen pregnancy and STDs. Some, based on religious precepts, have urged that such programs emphasize sexual abstinence. Others believe such programs should emphasize comprehensive sex education. Which approach is better? If you think messages from an unverifiable spirit world trump all else then maybe you’ll go for the abstinence-only program. If, however, you believe a successful program should be determined by empirical evidence you’ll opt for comprehensive sex education, as many studies have shown that abstinence-only programs are not as effective in reducing teen pregnancy and STDs.

You ask what we at CFI promote. We promote science and secularism. We at CFI believe secularism and science go hand-in-hand. We don’t believe we’re sending out a mixed message. Both secularism and science ask us to look to the natural world of facts and evidence for answers, and reliance on facts and evidence does have policy implications, even on so-called “values” issues such as freedom of conscience, same-sex marriage, and assisted dying, to name a few issues on which CFI advocates.

By the way (WARNING: SHAMELESS PLUG COMING), I expand on these topics in my forthcoming book The Necessity of Secularism (available from Pitchstone early December).

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