Published On: Wed, Apr 16th, 2014

Experts express concern about use of Stanislaw Burzynski’s ‘antineoplastons’ for cancer treatment

A group of medical, scientific and policy experts joined forces with the Center for Inquiry (CFI) in sending a letter to Food and Drug Administration (FDA) Commissioner, Margaret A. Hamburg, MD expressing concern over the agencies decision to allow cancer patients access to unapproved drugs provided by Texas-based doctor Stanislaw Burzynski.

Global Dispatch 200x119In a CFI press release today they note, Over the course of four decades, Dr. Burzynski has promoted and administered unproven, almost certainly ineffective, and toxic treatments to cancer patients. He has claimed for more than 36 years that the use of his drugs, “antineoplastons” (ANPs), results in substantially better outcomes than the current standard of evidence-based care for malignant brain tumors. He has even claimed to be able to cure irremovable brainstem tumors – despite the total lack of reliable evidence to support his claims.

Recently, Burzynski’s treatments were examined in depth in the March/April 2014 issue of Skeptical Inquirer, the science magazine published by CFI’s Committee for Skeptical Inquiry. In particular, an essay by Dr. David H. Gorski, MD, PhD, FACS, analyzes the history of Dr. Burzynski’s claims and makes starkly clear that no scientific evidence exists to support his treatments.

In the letter they state:

We appreciate that the FDA has been a stalwart defender of science and evidence-based medicine. Throughout its history, the FDA has worked in good faith to protect the American people from unsafe food and drugs, especially those pushed by people seeking to reap profit by misleading and harming others.

That is why we are puzzled and dismayed by a recent decision by the FDA to allow single patient Investigational New Drug (IND) applications for patients to be treated with ANPs. While it is true that this decision also banned Burzynski from submitting such INDs, we respectfully submit that this decision is at odds with the FDA’s history and inconsistent with the agency’s obligation to protect the American public from unsafe and ineffective drugs. While the FDA may believe its decision shows compassion towards the patients and families of Dr. Burzynski, we hold that its decision will only increase their agony and suffering.

Desperate families will now spend their loved ones’ remaining time chasing the phantom of the promise that a qualified oncologist will agree to do the not inconsiderable bureaucratic and scientific work necessary to treat these patients on single patient INDs. It is also questionable whether any qualified IRB not run by a longtime friend of Stanislaw Burzynski and the chair of the BRI board of directors, as the BRI IRB is, would approve such INDs.

CFI, a nonprofit that advances reason, science, and secular values, concludes in its letter:

The FDA has an obligation to minimize the damage being done by purveyors of false medical treatments who harm others, such as Dr. Burzynski. That is why we now urge you to move to immediately end Dr. Burzynski’s clinical trials of ANPs, rescind his status as a medical researcher, and, in concert with the HHS Office of Human Research Protection under whose jurisdiction it falls, close his Institutional Review Board permanently. We also urge you to make clear to Dr. Burzynski’s patients, and the general public, that the agency is taking these measures because of the lack of scientifically reliable evidence to support Burzynski’s claims regarding the efficacy of antineoplastons, and his long record of non-compliance with regulations designed to protect human research subjects.”

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