[23] – 1995 (10/5/1995) – Robert B. Lanman to Burzynski (1 pg.)

This page is linked to:
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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
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https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[23] – 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

cc:

D. Parkinson, M.D.
M. McCabe, R.N.
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1995 (10/5/1995) – Robert B. Lanman to Richard A. Jaffe [19]
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[5] – 1991 (11/15/1991) – Dr. Michael J. Hawkins to Decision Network

This page is linked to:
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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
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https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[5] – 1991 (11/15/1991) – Dr. Michael J. Hawkins to Decision Network
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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

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