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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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[19] – 1995 (6/6/1995) – Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health and Human Services (HHS), Public Health Service, National Institutes of Health (NIH) 3 page letter to Burzynski
This letter is intended to respond to the major issues which have been raised in your recent correspondence of 4/20/1995 and 5/16/1995
Your accusations are serious and require comment
I will 1st address the questions you raised about individual patients participating in the NCI-sponsored antineoplaston studies
2 patients were treated at the National Cancer Institute
Patient .26-77-03-9 had evidence of focal glioblastoma multiforme on the biopsy reviewed at the NCI
A different specimen submitted to Dr. Rorke may or may not be relevant
This patient, however, had a brain scan 3 weeks prior to study entry
Patient .27-53-76-5 had a tumor which was 0.8 cm larger than the eligibility criteria dictated
Although pharmacologic data were obtained on both, neither patient is counted in an assessment of response
Both patients had objective tumor progression and are now off study
With respect to the other patients, I am including specific patient summaries from the treating investigators which address your other concerns; in particular, a response to your serious and unfounded statement that patient #196370 was treated in an unethical manner
Also contrary to your statement, you have been sent monthly clinical summaries of these patients since 7/1994 directly from Theradex
(see 3/9/1994 letter)
Having provided this information, I must convey my deep pessimism about the potential for continued interactions with you regarding these trials
Given recent events and your clearly articulated bias that the Mayo Clinic, Memorial Sloan Kettering Hospital and even the National Cancer Institute could not fairly test your product
(please see your letters of 10/26/1993 and 4/20/1995),
I now see a diminishing chance for a productive dialogue with you
Historically, the NCI has demonstrated pragmatism and flexibility in working with a wide variety of individuals and organizations to explore diverse interventions of potential benefit to the cancer patient
However, such a fruitful collaboration may simply not be possible with you
Pg. 2
The decision to suspend the NCI antineoplaston studies was reached by the investigators and the NCI and was explained in our letter of 5/12/1995
(see enclosed)
While we have frequently solicited your advice, we are in no way obligated to obtain your consent
Our interactions with you have been similar to those with pharmaceutical companies or other independent investigators
In the interest of testing antineoplastons, we have consistently considered your advice and recommendations but that in no way cedes control of these studies to you
(please refer to our letters of 7/15/1993, 10/20/1993, and 11/2/1993)
Your insistence on dictating the manner in which we conduct our review of these clinical trials is both presumptuous and inappropriate
The future of these trials rests entirely with the investigators and the NCI, since our primary obligation is to the American public
Recognizing your potential conflict of interest as the developer and the most visible proponent of antineoplastons, we could not responsibly act in any other manner
In contrast to the tenor of your unsupported statements, the NCI bases its position on scientific data
You have stated that you have a vast clinical experience with antineoplastons and we have generally been deferential to your demands despite the lack of substantive data
However, our scientific standards are broadly applied to all studies
The data and level of proof we require from you is much the same as that for other professional collaborators who make such claims
The 7 case records initially examined by the NCI hardly constitute a definition scientific result
It is naive and misleading for you to suggest that the experience of 2 of those patients who had tumors in excess of 5 cm provides adequate proof for all your contentions about tumor size, dose, etc., unless these were the only 7 brain tumor patients from your entire experience who had any hint of benefit
To be precise, in order to responsibly and properly assess your claims and accusations (as per your 4/20/1995 letter), we request that you provide the following information:
1. Exactly how many adult patients with primary brain tumors have you evaluated and treated with antineoplastons?
2. When analyzed by histological type, performance status, prior therapy, concurrent therapy (including chemotherapy), disease size and focality, how many adult brain tumor patients had objective responses?
Please characterize the quality and magnitude and duration of these responses
3. What dose, duration, schedule, and composition of antineoplastons did these patients receive?
Which of these patients benefited objectively?
What toxicities were encountered?
Do you have pharmacokinetic or pharmacodynamic data to support your contention that certain types of brain tumor patients require specific regimens?
4. For these patients, what statistical analyses relate patient or tumor characteristics with exact treatment regimen and outcome?
Pg. 3
If you provide such specific data, we can properly assess your claims
Lacking such information, we cannot
Moreover, your charges that patients received inappropriate care are not supportable without such detailed information
If, after careful consideration, the investigators at Memorial Sloan Kettering and Mayo Clinic do not reopen their studies, it is unlikely that the NCI will attempt to conduct further antineoplaston trials
Any unused antineoplaston material will, of course, be returned to you
Since we can make no judgement about the benefit or toxicity of antineoplastons at this time, we will be interested in the published outcome of peer reviewed studies that you or others may perform
If the NCI investigators choose to continue these studies, you will be so informed
In either circumstance, we will continue to sponsor clinical research of small molecules that may have differentiating properties (such as pure phenylacetate and phenylbutyrate)
cc:
Senator Joseph Biden
Senator Barbara Boxer
Senator Diane Feinstein
Senator Tom Harkin
Senator Barbara Mikulski
Congressman Berkley Bedell
Congresswoman Nancy Pelosi
Dr. Jan Buckner
Dr. Jay Greenblatt
Mr. Richard Jaffe
Dr. Wayne Jonas
Mr. Robert Lanman
Ms. Mary McCabe
Dr. Mark Malkin
Dr. Tony Murgo
Dr. Ralph Moss
Dr. David Parkinson
Dr. Edward Sondik
Dr. Mario Sznol
Dr. Dorothy Tisevich
Dr. Alan Trachtenberg
Mr. Frank Wiewel
Dr. Robert Wittes
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1993 (10/26/1993) – Burzynski to
1994 (3/9/1994) –
1994 (7/1994) – Burzynski to Theradex
1995 (4/20/1995) – Burzynski to
1995 (5/12/1995) – to Burzynski
1995 (5/16/1995) – Burzynski to
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