“But see Burzynski.”
With a few minutes of internet searches you will find many examples where Burzynski failed to follow proper procedures in his studies. Among the problems have been the following:
The head of his Institutional Review Board IRB) to insure the safety of research is on the Board of Directors of his clinic. Imagine a Merck or Pfizer Board Member in charge of safety for their research — everyone would justifiably be screaming “Conflict of Interest!”
When patients have had prior chemotherapy or radiation, it is necessary to wait for some time prior to enrolling them into a new study lest the effects of the prior treatment falsely be attributed to the new treatment. Burzynski has not always observed this.
Burzynski has failed to report all serious adverse events (SAEs) and adverse events (AEs) to the FDA and/or IRB. This means you can’t trust his data regarding the safety of the treatments.
Burzynski has failed to follow proper informed consent procedures.
Burzynski has failed to keep proper records, failed to make proper progress reports, and failed to get the proper IRB approvals.
Burzynski’s IRB (run by a Board member, as noted above) approved research without determining that the risks to subjects were minimized and that risks to subjects were reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be expected to result. This is an essential criteria for any medical research and was put into place after atrocities such as the Nazi medical experiments and the Tuskegee study. The IRB fell down in numerous other areas as well.
After a child died from the side effects of the therapy — with a blood sodium level 50% higher than normal — the FDA forbade him from enrolling any more children. This petition was an attempt by Burzynski to bypass the rules and regulations that protect patients from these kinds of abuses. I am sorry for the family here, but the only real conclusion is that they and the supporters of this petition have been taken in by a quack.