Reports published by the FDA show unrecorded adverse events, failure to obtain proper informed consent, failure to disclose additional costs and systematic destruction of the very patient records that might establish whether the treatment works or not.
This follows on from the suspension of his Institutional Review Board, the closing of all trials to new participants, the withdrawal of trials that have not yet recruited and the removal of antineoplastons from the list of available treatments at the Burzynski Clinic.
This is quite big.
Note: there is no credible evidence to support the claim that Burzynski has a PhD.
Read these documents.
Legally informed consent was not obtained from a subject or the subject’s legally authorized representative.
That is what led to Andrew WakefieldW being struck off.
4. The S. R. Burzynski Study Monitoring Plan, MQA-001 Revision A (Monitoring Plan), Section 16, Adverse Events, requires Monitoring and Quality Assurance (MQA) staff to “verify that information on all AE are … summarized in the CRFs on monthly basis.”
You failed to monitor as required by Section 1 6 of your Monitoring Plan. The investigator did not report adverse events (AEs) experienced by study subjects, including 18 cases of hypernatremia.
Hypernatremia is a commonly reported side effect of “antineoplastons” due to the exceptionally high sodium levels in the drugs.
But by far the most serious item, given that Burzynski was notionally running clinical trials with the claimed intent of receiving marketing approval for antineoplastons is this:
Failure to prepare or maintain adequate case histories with respect to observations and data pertinent to the investigation.
a. Your MRI tumor measurements initially recorded on worksheets at baseline and on-treatment MRI studies for all study subjects were destroyed and are not available for FDA inspectional review.
b. Original case report forms (CRFs) for studies [elided] on which data were originally recorded and reported to the Sponsor were not available for FDA inspection and review. As stated by study personnel, original CRFs were not retained with the revised CRF versions.
Yes, you read that right. The baseline and treatment records for patients on the “clinical trials” were destroyed.
Without that data, without evidence that proper informed consent was obtained, and with the evidence of ethical violations and failure to report adverse events, it is unlikely that any reputable journal will publish the one study that has completed; the balance are probably unpublishable due to destruction of data.
Feel free to send details of suitable commercial property in Tijuana to: Stanislaw Burzynski MD, 4040 North Central Expressway, Suite 300, Dallas, T 75204
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.