[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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[22] – 1995 (9/19/1995) – Dr. Michael A. Friedman to Burzynski (2 pgs.)

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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[22] – 1995 (9/19/1995) – Dr. Michael A. Friedman, Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH) 2 page letter to Burzynski

I am replying to your 8/29/1995, letter in which you requested “detailed records” of the patients treated in the National Cancer Institute sponsored trials of antineoplastons

Our records indicate that the data has been regularly supplied to you by our contractor, Theradex, as listed below:

Date Report

7/18/1994 Clinical Studies Summary
8/24/1994 Clinical Studies Summary
9/19/1994 Clinical Studies Summary
10/24/1994 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report
11/14/1994 Clinical Studies Summary
12/19/1994 Clinical Studies Summary
1/13/1995 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report
2/21/1995 Clinical Studies Summary
3/15/1995 Clinical Studies Summary
4/10/1995 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report

Pg. 2

I am enclosing a summary of the categories of data that are included in the reports you have received

These reports are the same ones that have been provided to us by the contractor during the conduct of the Antineoplaston studies

Both the format and frequency of these reports are routine for reporting data of ongoing NCI Phase II trials to the Cancer Therapy Evaluation Program staff

These are also the same types of reports that are provided to pharmaceutical companies when they are cosponsors of a study

We have no individual patient records in our possession in addition to the Theradex reports

As of the last report provided to you of 4/10/1995, prior to the studies being put on hold and subsequently closed, you were sent the same reports that were provided to CTEP staff and protocols T93-0078 and T93-0134

However, enclosed for your convenience is a recent print-out of the data that was prepared for our staff in a slightly different format

Once the routine quality control review of data entry has been completed, we will send you a final print-out
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1995 (9/19/1995) – Friedman to Burzynski [18]
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[21] – 1995 (8/23/1995) – 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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[21] – 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

cc:

M. Friedman, M.D.
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1995 (8/23/1995) – Robert B. Lanman to Richard A. Jaffe [17]
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