Yesterday, the FDA released inspection notes 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.
The information and its implications, should they hold up, are absolutely damning for the Burzynski Clinic and especially for the lead researcher, Stanislaw Burzynski. Those of us who have been researching this topic have known about these findings for a long time, from almost the moment it could be requested through a Freedom of Information Act request (6 months before it appeared on the FDA website), but we have been careful to not release it through blogs. We wanted to see that it got as high profile a release as possible. Of course, the cat is out of the bag in a big way, and so I want to let you know what these documents say.
Among the newly released observations by FDA inspectors:
1) 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.
2) Additionally, some patients admitted failed to meet the inclusion criteria for the study.
3) 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.
4) Patients who had Grade 3 or 4 toxic effects were 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.
5) 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.
6) 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.
All of that is included in the first observation. The second observation showed that Burzynski failed to maintain the records required by his protocols. Specifically:
1) "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. I'd be stunned if this finding were not investigated by legal authorities.
2) 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.)
3) The FDA observed that the informed consent document did not include a statement of extra costs that might be incurred. Specifically, some informed consent documents were signed days to weeks before billing agreements, and in a couple of cases no consent form could be found.
4) The clinic was unable to account for its stock of antineoplastons.
Get fired up. Write about the findings, tweet links to the findings, tell your doctors and ask them to complain to the Texas Medical Board. We have to make sure that nothing like this EVER happens again.
Bob Blaskiewicz is a Marion L. Brittain Postdoctoral Fellow at Georgia Tech in Atlanta, where he teaches writing and research courses that take extraordinary claims as their topic. He is co-editor of the site Skeptical Humanities.