Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet “fact sheet”

[1] – 1995 (10/1995) – The National Cancer Institute (NCI) at the National Institutes of Health (NIH) issued its CancerNet “fact sheet”

The problem is that there were “factual issues” with the CancerNet “fact sheet”
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[0] – All Americans are “presumed to know the law:”

Title 18, Part I, Chapter 47, § 1001

18 USC § 1001 – Statements or entries generally

(3) “makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry”
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Below is how the “fact sheet” looked before and after the “fact sheet’s” “factual issues” were fixed
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BOLD = changes
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[1] – 10/1995 – CancerNet from the National Cancer Institute

CANCER FACTS

National Cancer Institute
National Institutes of Health
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[2] – 5/20/2002 – CANCER FACTS

National Cancer Institute • National Institutes of Health Department of Health and Human Services
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[1] – 10/1995 – National Cancer Institute-Sponsored Clinical Trials of Antineoplastons

Antineoplastons are a group of compounds originally isolated from urine by Dr. Stanislaw Burzynski, who claims that they inhibit cancer cell growth
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[2] – 5/20/2002 – Antineoplastons

Antineoplastons are a group of synthetic compounds that were originally isolated from human blood and urine by Stanislaw Burzynski, M.D., Ph.D., in Houston, Texas
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[1] – 10/1995 – Dr. Burzynski has used these compounds to treat patients with various cancers
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[2] – 5/20/2002 – Dr. Burzynski has used antineoplastons to treat patients with a variety of cancers
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[1] – 10/1995 – In 1991, a “best case series” review was conducted by the National Cancer Institute (NCI) to evaluate clinical responses in a group of patients treated at Dr. Burzynski’s Houston facility
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[2] – 5/20/2002 – In 1991, the National Cancer Institute (NCI) conducted a review to evaluate the clinical responses in a group of patients treated with antineoplastons at the Burzynski Research Institute in Houston
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[1] – 10/1995 – For this review, Dr. Burzynski selected from his entire clinical experience seven brain tumor patients whom he felt had a beneficial effect from antineoplastons
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[2] – 5/20/2002 – The medical records of seven brain tumor patients who were thought to have benefited from treatment with antineoplastons were reviewed by NCI
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[3] – 10/27/1995 – Burzynski objected to [1] in a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH), on page 1:

[A] – Gives the reader the impression that in his entire clinical experience he had only 7 patients who benefitted from antineoplaston treatment

[B] – He prepared not 7, but dozens of cases for the NCI reviewers

[C] – The reviewers were able to spend just one day at the clinic–enough time to review only 7 cases

(averaging one case per hour)
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[1] – 10/1995 – This series did not constitute a formal clinical trial, since it was a retrospective review of medical records, did not include all available patient information, and included only cases selected by Dr. Burzynski
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[2] – 5/20/2002 – This did not constitute a clinical trial but, rather, was a retrospective review of medical records, called a “best case series.”
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[3] – 10/27/1995 – Burzynski objected to [1] in a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH), on page 1:

[D] – The patient medical records that NCI scientists reviewed were exhaustive and did contain “all available patient information.”

[E] – Michael Hawkins, M.D., leader of the site visit team, specifically complimented him on how complete and well-organized they were

[F] – 1991 (11/15/1991) – 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) sent a 1 page Memorandum Re:
Antineoplaston
to Decision Network:, which advised, in part:

“Seven patient cases were presented at the site visit and the records, pathology slides and scans documenting response were reviewed”
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[1] – 10/1995 – The reviewers of this series determined that there was presumptive evidence of antitumor activity and NCI then proposed that Phase II clinical trials be conducted to evaluate more definitively the response rate and toxicity of antineoplastons in adult patients with refractory brain tumors
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[2] – 5/20/2002 – The reviewers of this series found evidence of antitumor activity, and NCI proposed that formal clinical trials be conducted to further evaluate the response rate and toxicity of antineoplastons in adults with advanced brain tumors
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[F] – 1991 (11/15/1991) – 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)
sent a 1 page Memorandum Re:
Antineoplaston
to Decision Network:, which advised, in part:

“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”

[3] – 10/27/1995 – Burzynski objected to [1] in a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH), on page 1:

[G] – The statement of the NCI scientists who actually reviewed patient records was quite different from the above

Their report stated:

“The site visit team determined that antitumor activity was documented in the best case series and that the conduct of Phase II trials was indicated to determine the response rate

(minutes of Decision Network committee meeting)
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[1] – 10/1995 – The decision by NCI to sponsor the study of an agent in a clinical trial does not indicate that the agent is or will be useful in the treatment of cancer patients, only that it merits further evaluation in a research setting

Efforts to study antineoplastons in a scientifically rigorous manner have required complex interactions among NCI, clinical investigators, the National Institutes of Health’s (NIH) Office of Alternative Medicine, the Food and Drug Administration, advocates from the alternative medicine community, and Dr. Burzynski
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[1] – 10/1995 – Two protocols were developed by the participating Cancer Center investigators with extensive review and input from NCI and Dr. Burzynski
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[2] – 5/20/2002 – Investigators at several cancer centers developed protocols for two phase II clinical trials with review and input from NCI and Dr. Burzynski
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[1] – 10/1995 – These studies began in 1993 at Memorial Sloan-Kettering Cancer Center, Mayo Clinic, and the NIH Clinical Center
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[2] – 5/20/2002 – These NCI-sponsored studies began in 1993 at the Memorial Sloan-Kettering Cancer Center, the Mayo Clinic, and the Warren Grant Magnuson Clinical Center at the National Institutes of Health
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[1] – 10/1995 – However, accrual to these studies was very slow and only nine patients were enrolled
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[2] – 5/20/2002 – Patient enrollment in these studies was slow, and by August 1995 only nine patients had entered the trials
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[1] – 10/1995 – On 8/18/1995, the studies were closed because a consensus could not be reached with Dr. Burzynski on the proposed changes in the protocol to increase accrual, and there was no hope of completing the studies in a timely manner
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[2] – 5/20/2002 – Attempts to reach a consensus on proposed changes to increase accrual could not be reached by Dr. Burzynski , NCI staff, and investigators, and on 8/18/1995, the studies were closed prior to completion
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[3] – 10/27/1995 – Burzynski objected to [1] in a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH), on page 1:

[H] – The only reason the clinical trials of antineoplastons were stopped is that NCI would not conduct them as per our written agreement

[I] – Even the NCI’s own previous “fact sheet” on antineoplastons, dated 2/17/1994, states that

“The NCI reviewed 7 cases of patients with primary brain tumors that were treated by Dr. Burzynski with antineoplastons and concluded that antitumor responses occurred

[J] – The NCI never made any effort to “reach a consensus.”

[K] – It simply violated the written protocol we had agreed upon

[L] – Without informing me, NCI changed the rules to allow patients with any size or number of tumors, low performance scores, and spinal cord metastases

[M] – When I found out and insisted that NCI either conduct the study as agreed or inform patients that I felt it was conducting the study improperly, NCI cancelled it
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[1] – 10/1995 – Because these studies were closed prior to completion, no conclusions can be made about the effectiveness or toxicity of antineoplastons
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[2] – 5/20/2002 – Because of the small number of patients in these trials, no definitive conclusions can be drawn about the effectiveness of treatment with antineoplastons
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[1] – 10/1995 – It is rare that this kind of NCI-sponsored clinical study cannot be successfully completed

The NCI is disappointed by this outcome but is continuing to evaluate related compounds in clinical trials in order to determine if they may be of benefit in the treatment of patients with cancer
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REFERENCES:
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[1] – Date Last Modified 10/1995
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CancerNet from the National Cancer Institute

CANCER FACTS

National Cancer Institute
National Institutes of Health

National Cancer Institute-Sponsored Clinical Trials of Antineoplastons

Antineoplastons are a group of compounds originally isolated from urine by Dr. Stanislaw Burzynski, who claims that they inhibit cancer cell growth

Dr. Burzynski has used these compounds to treat patients with various cancers

In 1991, a “best case series” review was conducted by the National Cancer Institute (NCI) to evaluate clinical responses in a group of patients treated at Dr. Burzynski’s Houston facility

For this review, Dr. Burzynski selected from his entire clinical experience seven brain tumor patients whom he felt had a beneficial effect from antineoplastons

This series did not constitute a formal clinical trial, since it was a retrospective review of medical records, did not include all available patient information, and included only cases selected by Dr. Burzynski

The reviewers of this series determined that there was presumptive evidence of antitumor activity and NCI then proposed that Phase II clinical trials be conducted to evaluate more definitively the response rate and toxicity of antineoplastons in adult patients with refractory brain tumors

The decision by NCI to sponsor the study of an agent in a clinical trial does not indicate that the agent is or will be useful in the treatment of cancer patients, only that it merits further evaluation in a research setting

Efforts to study antineoplastons in a scientifically rigorous manner have required complex interactions among NCI, clinical investigators, the National Institutes of Health’s (NIH) Office of Alternative Medicine, the Food and Drug Administration, advocates from the alternative medicine community, and Dr. Burzynski

Two protocols were developed by the participating Cancer Center investigators with extensive review and input from NCI and Dr. Burzynski

These studies began in 1993 at Memorial Sloan-Kettering Cancer Center, Mayo Clinic, and the NIH Clinical Center

However, accrual to these studies was very slow and only nine patients were enrolled

On 8/18/1995, the studies were closed because a consensus could not be reached with Dr. Burzynski on the proposed changes in the protocol to increase accrual, and there was no hope of completing the studies in a timely manner

Because these studies were closed prior to completion, no conclusions can be made about the effectiveness or toxicity of antineoplastons

It is rare that this kind of NCI-sponsored clinical study cannot be successfully completed

The NCI is disappointed by this outcome but is continuing to evaluate related compounds in clinical trials in order to determine if they may be of benefit in the treatment of patients with cancer
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[2] – This fact sheet was reviewed on 7/13/01

Editorial changes were made on 5/20/02
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CANCER FACTS

National Cancer Institute • National Institutes of Health Department of Health and Human Services

Antineoplastons

Antineoplastons are a group of synthetic compounds that were originally isolated from human blood and urine by Stanislaw Burzynski, M.D., Ph.D., in Houston, Texas

Dr. Burzynski has used antineoplastons to treat patients with a variety of cancers

In 1991, the National Cancer Institute (NCI) conducted a review to evaluate the clinical responses in a group of patients treated with antineoplastons at the Burzynski Research Institute in Houston

The medical records of seven brain tumor patients who were thought to have benefited from treatment with antineoplastons were reviewed by NCI

This did not constitute a clinical trial but, rather, was a retrospective review of medical records, called a “best case series.”

The reviewers of this series found evidence of antitumor activity, and NCI proposed that formal clinical trials be conducted to further evaluate the response rate and toxicity of antineoplastons in adults with advanced brain tumors

Investigators at several cancer centers developed protocols for two phase II clinical trials with review and input from NCI and Dr. Burzynski

These NCI-sponsored studies began in 1993 at the Memorial Sloan-Kettering Cancer Center, the Mayo Clinic, and the Warren Grant Magnuson Clinical Center at the National Institutes of Health

Patient enrollment in these studies was slow, and by August 1995 only nine patients had entered the trials

Attempts to reach a consensus on proposed changes to increase accrual could not be reached by Dr. Burzynski , NCI staff, and investigators, and on 8/18/1995, the studies were closed prior to completion

A paper describing this research, “Phase II Study of Antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in Patients With Recurrent Glioma,” appears in Mayo Clinic Proceedings 1999, 74:137–145

Because of the small number of patients in these trials, no definitive conclusions can be drawn about the effectiveness of treatment with antineoplastons

At present, the Burzynski Research Institute is conducting trials using antineoplastons for a variety of cancers
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[1] – Date Last Modified 10/1995
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20130919-152521.jpg

20130919-152702.jpg
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[2] – This fact sheet was reviewed on 7/13/2001

Editorial changes were made on 5/20/2002
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20130919-174650.jpg

20130919-174914.jpg
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[2]
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http://www.emory.edu/KomenEd/PDF/Treatment/Antineoplastons.pdf
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[3] – 10/27/1995 – Burzynski sent a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH)
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https://stanislawrajmundburzynski.wordpress.com/2013/09/18/24-1995-10271995-burzynski-to-dr-richard-klausner-7-pgs/
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[0] – Title 18, Part I, Chapter 47, § 1001
——————————————————————
18 USC § 1001 – Statements or entries generally
——————————————————————
http://www.law.cornell.edu/uscode/text/18/1001
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[F] – 1991 (11/15/1991) – 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) sent a 1 page Memorandum Re:
Antineoplaston
to Decision Network
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/17/5-1991-11151991-dr-michael-j-hawkins-to-decision-network/
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[G] – 1991 (12/2/1991) – NCI Decision Network Report on Antineoplastons:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/17/6-1991-12291-nci-decision-network-report-on-antineoplastons/
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Critiquing: Dr. Michael A. Friedman, 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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[19] – 1995 (6/6/1995) Dr. Michael A. Friedman to Burzynski (3 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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[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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