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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 (10/5/1995) – Robert B. Lanman National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Counsel, Public Health Division 1 page letter to Richard A. Jaffe, Esq.
This is in response to your 9/8/1995 letter in which you reiterate your request for copies of individual patient records and argue that the protocol for the study of Antineoplastons specifically provides that medical records of patients treated by the Principal Investigators will be provided to Dr. Burzynski
We have reviewed the protocols and have not found any such commitment
Moreover, it is not the practice of the National Cancer Institute (NCI) to obtain individual patient records from Principal Investigators
It is our understanding that NCI offered to allow Dr. Burzynski to participate in an interim and final meeting in which patient data from the study was to be reviewed
However, these meetings never took place because of the insufficient patient accrual and decision not to complete the study
With regard to the portion of the medical record which you forwarded, the stamp does indicate that the patient was seen at the National Institutes of Health’s Clinical Center
We have learned that 2 patients were enrolled in the Sloan-Kettering study through the Clinical Center and hence, even though the Clinical Center did not have its own protocol, it has medical records for those 2 individuals
However, without the consent of the patient or the next of kin in the event that the patient is deceased, we cannot release these records
See 45 CFR S 5b.9.
Given that you apparently have already obtained at least one of the patient’s records, we fail to understand why you are pursuing this matter
D. Parkinson, M.D.
M. McCabe, R.N.
1995 (10/5/1995) – Robert B. Lanman to Richard A. Jaffe