Skeptics for the Protection of Cancer Patients runs down what is contained in documents released by the US Food and Drug Administration (FDA) regarding dubious cancer doctor Stan Burzynski. Hey, Stan, it’s NOT looking good for you and your clinic:
Why don’t doctors tell you that Stanislaw Burzynski has a non-toxic cure for cancer?
Because it’s toxic, and any evidence it might cure cancer, has been shredded.
Stanislaw Burzynski runs cancer treatment center that uses an experimental, unproven and potentially harmful form of treatment that he claims cures cancer. But he has not done the science to show that it actually does anything useful. More than that, is the way he has utterly failed to live up to medical, ethical and scientific standards, as noted in our continuing coverage of his expensive treatment center.
Yesterday, the FDA released inspection notes [PDF] from a visit to the Burzynski Clinic that took place at the beginning of this year. One of these files had already been released to the public earlier this year. A blogger has picked up on a new document that information and its implications, should they hold up, are absolutely damning for the Burzynski Clinic and especially for the lead researcher, Stanislaw Burzynski.
Among the observations noted by FDA inspectors:
Burzynski “failed to comply with protocol requirements related to the primary outcome, therapeutic response [...] for 67% of study subjects reviewed during the inspection.”
Some patients admitted to the study failed to meet the inclusion criteria for the study. Or they did not have a physician to monitor their progress prior to enrolling in a trial. Or, those patients showing toxic effect were not removed from the study.
Burzynski did not report all adverse events as required by his study protocols. Patients experienced hypernatremia (high sodium), for example.
Burzynski failed to maintain the records required by his protocols.
The FDA told Burzynski: “You failed to protect the rights, safety, and welfare of subjects under your care. Forty-eight (48) subjects experienced 102 investigational overdoses between January 1, 2005 and February 22, 2013, according to the [trial number redacted] List of Hospitalizations/SAE (serious adverse events) [redacted]/ Overdose [redacted]/Catheter Infection report. Overdose incidents have been reported to you [....] There is no documentation to show that you have implemented corrective actions during this time period to ensure the safety and welfare of subjects.” [emphasis added] It seems that these overdoses are related to the protocol, which requires family members to administer the drugs via programmable pump on their own. Further, patient records show that there were many more overdoses that were not included in the Hospitalization/SAE/Overdose list.
Tip: R. Blaskiewicz
Addition: FDA Documents Paint Disturbing Picture Of Burzynski Cancer Clinic – Forbes. Cool shout out for Bob Blaskiewicz and Tim Farley of Virtual Skeptics and Dr. David Gorski of Science-based Medicine.