This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
======================================
[5] – 1991 (11/15/1991) – Dr. Michael J. Hawkins to Decision Network
——————————————————————
Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services (HHS), Public Health Service, National Institutes of Health (NIH), National Cancer Institute (NCI)
Re: Antineoplaston
[7 pgs. – 1 pg.]
To: Decision Network
Attached is a summary of a review of a best case series of antineoplastons in the treatment of brain tumors which was conducted by CTEP at the Burzynski Research Institute and some background information on antineoplastons A10 and AS2-1
7 patient cases were presented at the site visit and the records, pathology slides and scans documenting response were reviewed
It was the opinion of the site visit team that antitumor activity was documented in this best case series and that the conduct of Phase II trials was indicated to determine the response rate
At the DN meeting, Dr. Burzynski will present some brief background data on antineoplastons and Dr. Nicholas Patronas, a neuroradiologist from the Clinical Center who was on the site visit team, will review the radiologic findings for the committee
Antineoplastons are being proposed for DN IV (Phase II trials)
We feel the 1st step is to confirm the observations of Dr. Burzynski in brain tumors
Initially 3 or 4 Phase II trials would be conducted (one trial in each of the following diseases: glioblastoma multiforme, anaplastic astrocytoma, pediatric brain tumors and possibly low grade astrocytomas) using antineoplaston A10 and AS2-1 in exactly the same manner Dr. Burzynski gave them in the cases we reviewed
A decision regarding subsequent trials (e.g.–other tumors, additional Phase I development, Phase III trials in brain tumors, etc) would be deferred until the results of these initial trials were known
Dr. Burzynski is willing to provide sufficient antineoplaston A10 and AS2-1 for these studies
The only impact on DCT would be the IND filing and the use of our clinical trials resources
cc: Dr. Burzynski
======================================
Didymus Judas Thomas' Hipocritical Oath Blog 