[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
======================================
[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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[2] – This fact sheet was reviewed on 7/13/2001
Editorial changes were made on 5/20/2002
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[2]
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Click to access 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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[24] – 1995 (10/27/1995) – 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
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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
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[5] – 1991 (11/15/1991) – 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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[6] – 1991 (12/2/1991) – 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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