March 28,

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Myrtle Norman
6 years ago
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1 April 16, 2014 The Honorable Margaret A. Hamburg, MD Commissioner Food and Drug Administration New Hampshire Ave. Silver Spring, MD Re: Stanislaw Burzynski and antineoplastons. Dear Commissioner Hamburg, We, the undersigned physicians, medical officials, scientists, and public policy scholars, write to you to express our deep concern regarding the Food and Drug Administration s (FDA) recent decision to allow cancer patients access to unapproved drugs provided by Stanislaw Burzynski. We submit this letter in collaboration with the Center for Inquiry, a nonprofit educational and advocacy organization, part of whose mission is to critically examine claims made by practitioners of alternative medicine. Dr. Burzynski, MD, PhD, has a long history of promoting unproven, almost certainly ineffective, and toxic treatments. In particular, Dr. Burzynski has claimed for more than 36 years that his drugs, antineoplastons (ANPs), result in substantially better outcomes than the current standard of care for malignant brain tumors. He has even claimed to be able to cure unresectable brainstem tumors with ANPs despite no reliable evidence to support his claims. Five months ago, Dr. Burzynski s clinic was the focus of a high-profile investigation by USA Today. 1 After a lengthy investigation, USA Today investigative reporter Liz Szabo detailed that Dr. Burzynski s drug treatments are both unsupported by evidence and harmful in their effects. For instance, as the article notes, the National Cancer Institute (NCI) has made clear that Dr. Burzynski has never published the results of a completed randomized controlled trial in a peer-reviewed medical journal that show that his drugs are an effective treatment for cancer, or even that they result in significant prolongation of survival. 2 This is despite the fact that in the late 1990s, Dr. Burzynski opened 72 phase II clinical trials of ANPs against various tumors. 3 Given the rapid lethality of many of the tumors studied in these clinical trials, one would expect that, if his treatment had scientific merit, he would have been able to complete and publish the results of many of 1 Szabo, Liz. Doctor accused of selling false hope to families. USA Today. Accessed March 28, National Cancer Institute. Questions and Answers About Antineoplastons. Accessed March 28, ClinicalTrials.gov. Search for Burzynski. Accessed April 2,

2 these trials in the 17 years since he submitted them. His failure to do so strongly suggests that there is no value to his treatment, because if there were he should have been able to report his results by now. Furthermore, while Burzynski has touted his treatment as an alternative to chemotherapy, the NCI has found that antineoplastons cause many of the same side effects as conventional chemotherapy: nausea, vomiting, headaches, muscle pain, confusion, and seizures. 4 In fact, as also stated by the NCI, Dr. Burzynski s drugs pose a risk of serious harm, including coma, swelling near the brain, and death. Therefore, his drugs are not only ineffective, but also pose a grave danger to the health and safety of cancer patients receiving them. Such toxicities might represent an acceptable trade-off if there were strong evidence supporting the efficacy of ANPs, as there is for approved chemotherapeutic agents, some of which produce significant toxicity. But there is no strong evidence supporting the efficacy of ANPs. To make matters worse, Dr. Burzynski continues to deceive people into thinking they should eschew proven medical treatments in favor of his clinical trials. The result is continued harm brought upon individuals and families. These points were covered in even greater detail in the March/April 2014 issue of the science magazine Skeptical Inquirer. 5 An article by Robert Blaskiewicz, Visiting Assistant Professor of Writing at the University of Wisconsin-Eau Claire, details the ongoing efforts by science advocates to investigate and challenge Mr. Burzynski s dangerous treatments, as well as raise funds for a legitimate cancer research hospital; and in a thorough and incisive essay, Dr. David H. Gorski, MD, PhD, FACS, analyzes the history of Dr. Burzynski s claims and removes any doubt regarding the lack of scientific evidence to support Burzynski s treatments. 67 The FDA formally recognized the problems with Dr. Burzynski s work, when it responded to the June 2012 death of a 6-year-old New Jersey boy with a brain tumor who was treated with ANPs by placing a partial clinical hold on Dr. Burzynski s pediatric 4 Mayo Clinic Proceedings. Phase II Study of Antineoplastons A10 (NSC ) and AS2-1 (NSC ) in Patients With Recurrent Glioma. February 1999, Volume 74. Accessed March 28, Skeptical Inquirer is the official magazine of the Committee for Skeptical Inquiry, an affiliate of the Center for Inquiry. 6 Blaskiewicz, Robert. Skeptic Activists Fighting for Burzynski s Cancer Patients. Skeptical Inquirer. March/April 2014, Volume Accessed April 1, atients 7 Gorski, David. Stanislaw Burzynski: Four Decades of an Unproven Cancer Cure. Skeptical Inquirer. March/April 2014, Volume Accessed April 1, n_cancer_cure

3 clinical trials, a hold that was extended to all of his clinical trials in early From January to March 2013, the FDA investigated the Burzynski Research Institute (BRI). The resulting warning letter to Dr. Burzynski in December 2013 noted that he inflated his success rates, did not adequately report side effects, and failed to prevent patients from repeatedly overdosing. 8 Worse, this latest warning letter is but the most recent in a string of such warning letters going back 15 years repeatedly detailing deficiencies in BRI clinical trial procedures and IRB operations. 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. 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. Thank you in advance for your consideration of this letter. Please do not hesitate to contact us with any questions or concerns. 8 Office of Scientific Investigations; Office of Compliance; Center for Drug Evaluation and Research; Food and Drug Administration. Warning Letter. December 3, Accessed March 28,

4 Respectfully, Stephen Barrett, MD Co- founder, National Council Against Health Fraud Robert Blaskiewicz, PhD Skeptics for the Protection of Cancer Patients Michael De Dora, MA Director, Center for Inquiry, Office of Public Policy Barbara Forrest, PhD Professor of Philosophy, Southeastern Louisiana University Kendrick Frazier Editor, Skeptical Inquirer Fellow, American Association for the Advancement of Science Christopher French, PhD, CPsychol, FBPsS, FRSA Professor of Psychology, Goldsmiths College, University of London

5 David Gorski, MD, PhD, FACS Professor of Surgery, Wayne State University Harriet Hall, MD Former U.S. Air Force flight surgeon Barry Karr Executive Director, Committee for Skeptical Inquiry Ronald A. Lindsay, JD, PhD President and CEO, Center for Inquiry William M. London, EdD, MPH Professor of Public Health, California State University, Los Angeles Eugenie C. Scott, PhD Chair, Advisory Council National Center for Science Education

6 Brahm Segal, MD Professor of Medicine, University at Buffalo School of Medicine Chief of Infectious Diseases, Roswell Park Cancer Institute Simon Singh, PhD Fellow, Committee for Skeptical Inquiry Sam Stubblefield, MD, FAAP Division of General Pediatrics Nemours, A.I dupont Hospital for Children Assistant Professor of Clinical Pediatrics, Thomas Jefferson Medical College CC: Janet Woodcock, MD, Director, Center for Drug Evaluation and Research

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