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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
 – 1995 (8/23/1995) – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Council, Public Health Division 1 page letter to Richard A. Jaffe, Esq.
This is in response to the issues raised in your 7/21/1995 letter
First, you raised questions as to how clinical trials of antineoplastons could proceed absent Dr. Burzynski’s concurrence
Although NCI clearly prefers to conduct or sponsor studies with permission of such an individual is not required
In the present case, even assuming that the clinical trials involved some of Dr. Burzynski’s patented products or processes, the use of antineoplastons would be permissible under the research exemption
However, in light of the recent decision to close the studies at the Mayo Clinic and Memorial Sloan-Kettering, conveyed to Dr. Burzynski in a letter from Dr. Michael A. Friedman dated 8/18/1995, these issues now seem moot
In addition, you requested in your letter that we provide you or Dr. Burzynski with the medical records of patients treated by the Principle Investigators
To our knowledge, Dr. Burzynski has received, on an ongoing basis, complete copies of the reports prepared by Theradex after the Principle Investigators submit their data
Dr. Burzynski has received precisely the same information that is provided to the National Cancer Institute (NCI)
The NCI does not possess any individual patient records to provide to Dr. Burzynski
Finally, we are not aware of any “committee” investigating Dr. Burzynski’s allegations regarding the protocols
M. Friedman, M.D.
1995 (8/23/1995) – Robert B. Lanman to Richard A. Jaffe