FDA findings about Burzynski are out

[rjblaskiewicz]

All,

On Thursday, Tim Farley notified us that form 483s (FDA inspection notes) from an inspection at the Burzynski Clinic in March were released in the FDA's FOIA electronic reading room. I have worked up a summary of the findings and have linked to the originals.

theotherburzynskipatientgroup.wordpress.com/damning-fda-findings-about-stanislaw-burzynskis-trials/

For the backstory on Burzynski and how he treats patients (like disposable ATMs) see the pair of TAM talks on him (by me and David Gorski) just posted on youtube by the JREF:

(Gorski's talk--Burzynski's history.)
http://www.youtube.com/watch?v=kxLJhZ1MTBQ&feature=c4-overview&list=UUdGkmb5zEDXnPSmQlV43t0Q

(Bob's talk--What he's done to patients)
http://www.youtube.com/watch?v=NqA5eWjr4pk&feature=c4-overview&list=UUdGkmb5zEDXnPSmQlV43t0Q

I'm hoping that this does not violate forum rules, but if you are interested in a coordinated push on congress to see how this happened and see to it that it never happens again, please email me at gmail. (same username)

 

[catsmate]

That link. Hopefully this will encourage people to avoid this dangerous, fraudulent quack.

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. A blogger has picked up on a new document should the its information and its implications hold up is absolutely damning for the Burzynski Clinic and especially for the lead researcher, Stanislaw Burzynski, about whom the report was written. 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. Now 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 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.
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.

 

[bigred]

Frankly this sounds like a big yawn. So he's full of it, his methods highly questionable, his results missing when it's convenient, nothing to prove anything he does even works, blah blah blah. All very old news and the pathetic FDA continuing to be a kickstand on a tank, near as I can tell. I'll have more interest when I see a link about this POS going to trial, FINALLY getting busted, and someone throwing away the key while the crowd cheers.