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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[16] – 1995 (4/20/1995) – Burzynski to Dr. Mario Sznol
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Mario Sznol, M.D., Department of Health and Human Services, National Institutes of Health
Dear Dr. Sznol,
Your letter of 4/3/1995
(copy attached)
does not provide adequate justification for the changes in the protocol for
“Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Advanced
Recurrent Astrocytomas.”
Let me make perfectly clear that, as the discoverer and developer of antineoplastons and the individual with nearly 20 years clinical experience using them, it is my professional opinion that the drugs will not produce substantial benefit in such advanced patients
The current protocol has had success only in patients who have tumors not exceeding 5 cm in diameter and who do not have multiple tumors or leptomeningeal or systemic metastases
As the Senior Investigator of NCI requested, patients should have Karnofsky Performance Status of not lower than 70%
(letter attached)
As I have repeatedly informed you, it is exactly because of the current protocol’s failure to benefit advanced patients that we developed new and more aggressive protocols for such advanced tumors, for example, provides antineoplaston A10 in doses 3 times greater than that specified in the protocol currently being used
In order to make such dosing possible, we are using a much higher concentration of A10 — 300mg/mL instead of 80mg/mL
The dosing schedule being used for such advanced tumors is also quite different
Instead of injections of each antineoplaston every 30 minutes, patients receive a much greater amount every 4 hours
Pg. 2
The acceptance of very advanced brain tumor patients to the current protocol would be highly unethical because there is no realistic chance they will have a meaningful response
The list attached to your letter of 4/3/1995 (enclosed), proves my observation that patients who had tumors substantially larger than 5 cm do not respond well under the current protocol
There were only 2 such patients, with the largest tumor diameter corresponding to 5.5 and. 6.5 cm
Both had less than 50% decrease in the size of their tumors
According to the existing protocol, patients should have more than a 50% decrease in tumor size to be classified as responders
Please bear in mind that the point of this trial is not to prove once again that this protocol does not work in patients with very large tumors, multifocal tumors, and low Karnofsky scores
We have already established this fact
Moreover, the informed consent form as currently written falsely implies that the discoverer of antineoplastons believes such advanced patients may benefit substantially from the current protocol
In fact, I have specifically informed you on several occasions that I do not believe advanced patients will obtain substantial benefit
Please be forewarned that you may face legal liability resulting from these unethical misrepresentations
We are anxiously awaiting the complete data on the 1st 5 patients as promised in your letter of 4/3/1995
Based on the limited information received from Theradex on the 1st 7 cases, we have reason to believe that the protocol has been violated in every case
5 cases have been accepted in violation of inclusion criteria
Due to interruptions in the treatment schedule and the time necessary to escalate the dosage, one of these patients received less than 3 weeks of full dose treatment
Such duration of treatment was not sufficient to show the effectiveness of the therapy
Finally, 2 additional patients were removed from the study and said to have progression of disease when in fact no progression was documented
One of these patients, #4369975, underwent tumor resection 3 weeks after discontinuation of the treatment with antineoplastons
Microscopic examination of the tumor specimen confirmed absence of viable tumor cells
It is clear that what was classified as tumor progression corresponded to extensive necrosis or tumor death
What I thought was especially inexcusable and unethical is that the 30 year old patient #196370, who clearly did not have progression of the tumor, was removed from the study against the criteria for removal listed in the protocol
This patients died a few months later
I strongly believe that if the patient had continued the treatment under the protocol, his life would have been saved
Attached to this letter, you will find a list of
Pg. 3
violations of the protocol
Based on these violations, it is clear that the current investigators are unable to conduct this study under the current protocol
I hereby request that:
1) The National Cancer Institute immediately terminate the current investigators and appoint mew investigators at different medical institutions acceptable to Burzynski Research Institute
2) Patient accrual must cease until such investigators and institutions are appointed
Until you appoint the new investigators, I will provide free treatment and medical care under my supervision as long as necessary to the patients currently being treated under the protocol
SRB/cf
Enclosure
cc:
Senator Joseph Biden
Senator Barbara Boxer
Senator Diane Feinstein
Senator Tom Harkin
Senator Barbara Mikulski
Congressman Berkly Bedell
Congresswoman Nancy Pelosi
Dr. Jan Buckner
Dr. Daniel Eskinazi
Dr. Michael Friedman
Dr. Jay Greenblatt
Mr. Richard Jaffe
Dr. Mark Malkin
Ms. Mary McCabe
Dr. Ralph Moss
Dr. David Parkinson
Ms. Dorothy Tisevich
Mr. Frank Wiewel
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1995 (4/20/1995) – Burzynski to [14]
1995 (4/20/1995) – Burzynski to [15] (3 pgs.)
1995 (4/3/1995) – Dr. Mario Sznol to Burzynski
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