Comment to the paper: The response and survival of children with recurrent diffuse intrinsic pontine glioma based on phase II study of antineoplastons A10 and AS2-1 in patients with brainstem glioma : Stanislaw R. Burzynski, Tomasz J. Janicki, Gregory S. Burzynski, Ania Marszalek.

Abstract

Although Burzynski et al. conclude that antineoplastons are a useful treatment, their results do not adequately support their conclusion, and much of what we know about antineoplastons suggests that antineoplastons can have serious and potentially life-threatening side effects, with no evidence of efficacy that could justify that risk. While many of the problems with the paper will be immediately apparent to readers (for instance, the decision to exclude over half of the patients from analysis), readers should also be aware of the context in which the study, BT-11, was conducted. In the 1990s, when the BT-11 trial was initiated, it was one of over 70 clinical trials of antineoplastons that, according Stanislaw Burzynski’s lawyer, Richard Jaffe, would allow Burzynski “to treat almost any patient Burzynski would want to treat!” In all the years since, not a single one of those 70+ clinical trials has culminated in a meaningful paper. For all intents and purposes, the medical community knows nothing more about antineoplastons than they did when the trials opened, and the current paper does not change that. Over the course of these never-ending and apparently unpublishable clinical trials, the US Food and Drug Administration has periodically inspected the Burzynski Research Institute (BRI) and the principal investigator, Stanislaw Burzynski. The FDA have released the observational notes (form 483s) and other documents from these inspections which specifically refer to BT-11, as well as to studies underway at the BRI concurrently with BT-11 and the BRI Institutional Review Board (IRB) that oversaw all of the studies. They are shocking reading, and detail an unbroken string of abysmal FDA site reviews of the Burzynski Research Institute spanning the last 14 years. For instance, a 483 form 2001 noted that “Subjects were started on antineoplaston treatment prior to the protocol-specified interval following prior chemotherapy and/or radiation therapy,” including a patient participating in trial BT-11, who had too recently been treated with etoposide. During the same visit, inspectors observed that “Not all serious adverse events and adverse events are reported to FDA and IRB,” including two patients in BT-11, including one patient who had to be removed from the chemotherapy all together because of recurring pancreatitis. Inspectors also observed a “failure to address and resolve reported patient overdoses in BRI query reports to determine the reason for the possible overdose and to take corrective action to prevent recurrence,” including two patients in BT-11. Additionally, the files of at least two patients in the BT-11 did not record independent tumor measurements by consultants. In the Establishment Inspection Report, the FDA investigator recorded: