[9] – 1993 (11/2/1993) – Dr. Michael A. Friedman to Burzynski

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
[9] – 1993 (11/2/1993) – Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment, National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Services, National Institutes of Health (NIH) to Burzynski [3 pgs.]

Department of Health and Human Services, Public Health Services, National Institutes of Health

Dear Dr. Burzynski:

With regard to your letter of 10/26/1993, you specifically state

“The medicine will be sent to you immediately once you make the corrections to the protocol that we have requested”

We have substantial factual disagreements and scientific reservations with many of the comments made in your 10/26/1993 letter, including your preposterous claim that the NCI wasted 8 months

Nonetheless, we will accede to all the modifications that you have stipulated

We do so because we are committed to beginning the clinical studies as quickly as possible

We presume that these are your final comments, since all the changes will have been made and we will have addressed all of your concerns regarding these studies

The revised protocol will be sent to you as soon as it is received from the investigators

Based on the promise in your letter, we expect that the drug will be shipped to the NCI repository the next day

The changes to made to the protocol are as follows:

1. The dose and schedule will be modified as exactly as your require

We believe this to be the dose and schedule found in your protocol BT6, with dose escalation and maximum dose guidelines for adults clarified in your letter of 10/13/1993

2. The Memorial study, as written, has 2 separate components, one for patients with glioblastoma multiforme and one for patients with anaplastic astrocytoma

Accrual to each stratum proceeds independently, and analyses of each stratum is separate

However, we will ask the investigators from Mayo Clinic to join the Memorial study, rather than conducting an independent trial

This will effectively evaluate on the one hand patients with glioblastoma multiforme, and on the other hands those with anaplastic astrocytoma

Pg. 2

Patients with either disease will be enrolled at both Memorial and Mayo sites

This modification has 2 advantages — it limits total accrual to 35 patients per histology, as you request; and it accelerates accrual, since each institution can enter both types of patients on the studies

3. As you stipulated, Fleming’s original statistical design will be used utilized
15 patients will be entered independently to each stratum; for each stratum, if there is 1 response, accrual will proceed to a total of 35 patients

Thus total accrual will be 70 patients if both strata proceed past the 1st stage

(the initial 15 patients per histology)

4. According to your wishes, all scans for tumor measurements and laboratory test will be performed within 7 days of initiating protocol therapy, rather than the standard 14 days now specified in the protocol

5. The eligibility criteria will be modified to accept only patients with a Karnofsky performance status of 70-100%

6. As you require, the protocol response criteria will be based on objective tumor measurements and will not include assessment of neurologic status

Neurologic status will be evaluated separately

7. In accordance with your letter, we will arrange a review of data after accrual of the 1st 5-6 patients, which should occur 6 months after the study has been initiated

This should be sufficient to assure that the conduct of the study is satisfactory

The Theradex database is also available to precisely determine if the conduct of the study has followed protocol guidelines; the study centers will also be audited on-site by Theradex (independent contractors) every 3 months

In your letter you express concern regarding what you perceive to be bias against alternative treatments by Mayo Clinic and Memorial investigators

Please note that the investigators participating in the antineoplaston studies volunteered to do so because of the findings of the NCI review of your best case series

To my knowledge none of the participating investigators have expressed (publicly or privately) a position for or against Antineoplastons

Both institutions have a distinguished record in clinical investigations, and have been leaders in subjecting all treatments (including alternative interventions) to fair and objective clinical research

We are confident that credible clinical studies will be conducted

Pg. 3

Finally, if even after modifying these studies in accordance with your stated wishes, you are unwilling to supply the antineoplaston materials, please inform me as quickly as possible

We will then seek alternative sources of this family of molecules for proper clinical evaluation

Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program, Division of Cancer Treatment, NCI


Dr. Samuel Broder
Dr. Jan Bruckner
Dr. Bruce Chabner
Dr. Jay Greenblatt
Dr. Joseph Jacobs
Dr. Mark Malkin
Ms. Mary McCabe
Dr. David Parkinson
Dr. Mario Sznol
Ms. Dorothy Tisevich

1993 (11/2/1993) – Dr. Michael A. Friedman to SRB [9]
1993 (11/2/1993) – Dr. Michael A. Friedman to Burzynski [14]
1993 (11/2/1993) – Dr. Michael A. Friedman to SRB [19] (3 pgs.)
1993 (11/2/1993) – Dr. Michael A. Friedman to Burzynski [24]
1993 (10/13/1993) – Burzynski to Dr. Michael A. Friedman
1993 (10/26/1993) – Burzynski to Dr. Michael A. Friedman