OVER 100 OVERDOSES AND ALL BASELINE SCANS “DESTROYED”
In November, the FDA released inspection notes from a visit to the Burzynski Clinic that took place at the beginning of last year. The owner, Stanislaw Burzynski, has claimed for over 35 years to have a proprietary treatment that treats the most deadly brain cancers (as well as AIDS and a whole host of other unrelated diseases). He has been distributing these drugs under the auspices of “clinical trials” for over 15 years. Of the over 60 trials that Burzynski opened he has completed and published exactly zero.
The latest FDA observations are damning in the extreme. For instance:
- Burzynski (as investigator, the subject of the inspection) “failed to comply with protocol requirements related to the primary outcome, therapeutic response [...] for 67% of study subjects reviewed during the inspection.” This means that several patients who were reported as “complete responses” did not meet the criteria defined in the investigational plan, as were patients who were reported as having a “partial response” and “stable disease.” This means that his outcomes figures for these studies are inaccurate.
- Additionally, some patients admitted failed to meet the inclusion criteria for the study.
- Even though patients needed to have a physician back home to monitor their progress prior to enrolling in a trial, the FDA found a patient who began receiving treatment before a doctor had been found.
- Patients who had Grade 3 or 4 toxic effects were supposed to be removed from treatment. One patient had 3 Grade 3 events followed by 3 Grade 4 events. Another patient had 7 disqualifying toxic events before he was removed from the study.
- Burzynski did not report all adverse events as required by his study protocols. One patient had 12 events of hypernatremia (high sodium), none of which was reported. There are several similar patients.
- 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.
- “Your [...] tumor measurements initially recorded on worksheets at baseline and on-study treatment [...] studies for all study subjects were destroyed and are not available for FDA inspectional review.” This is one of the most damning statements, as without any…not a single baseline measurement…there is no way to determine any actual effect of the antineoplaston treatment. This means that Burzynski’s studies–which by last account cost $30,000 to begin and $7000 a month to maintain–are unpublishable.
- Some adverse events were not reported to the Burzynski Clinic IRB for years. (One patient had an adverse event in 1998 and the oversight board did not hear about it until 2005.)
Since the release of this information, the Burzynski Clinic has been the subject of a USA Today feature which chronicled his abysmal research track record and failure to produce meaningful results. Now that Burzynski is facing sanctions with the FDA and the Texas Medical Board, it is time that skeptics acted to make sure that this Teflon quack does not get off again. Please sign our new petition. The Skeptics for the Protection of Cancer Patients will see to it that your signature makes gets in the hands of lawmakers.