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”
——————————————————————
[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”
——————————————————————
Below is how the “fact sheet” looked before and after the “fact sheet’s” “factual issues” were fixed
======================================
BOLD = changes
======================================
[1] – 10/1995 – CancerNet from the National Cancer Institute

CANCER FACTS

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

National Cancer Institute • National Institutes of Health Department of Health and Human Services
======================================
[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
——————————————————————
[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
======================================
[1] – 10/1995 – Dr. Burzynski has used these compounds to treat patients with various cancers
——————————————————————
[2] – 5/20/2002 – Dr. Burzynski has used antineoplastons to treat patients with a variety of cancers
======================================
[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
——————————————————————
[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
======================================
[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
——————————————————————
[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
——————————————————————
[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)
======================================
[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
——————————————————————
[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.”
——————————————————————
[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”
======================================
[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
——————————————————————
[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
——————————————————————
[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)
======================================
[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
======================================
[1] – 10/1995 – Two protocols were developed by the participating Cancer Center investigators with extensive review and input from NCI and Dr. Burzynski
——————————————————————
[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
======================================
[1] – 10/1995 – These studies began in 1993 at Memorial Sloan-Kettering Cancer Center, Mayo Clinic, and the NIH Clinical Center
——————————————————————
[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
======================================
[1] – 10/1995 – However, accrual to these studies was very slow and only nine patients were enrolled
——————————————————————
[2] – 5/20/2002 – Patient enrollment in these studies was slow, and by August 1995 only nine patients had entered the trials
======================================
[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
——————————————————————
[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
——————————————————————
[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
======================================
[1] – 10/1995 – Because these studies were closed prior to completion, no conclusions can be made about the effectiveness or toxicity of antineoplastons
——————————————————————
[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
======================================
[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
======================================
REFERENCES:
======================================
[1] – Date Last Modified 10/1995
——————————————————————
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
——————————————————————
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
======================================
[1] – Date Last Modified 10/1995
——————————————————————

20130919-152521.jpg

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

Editorial changes were made on 5/20/2002
——————————————————————

20130919-174650.jpg

20130919-174914.jpg
——————————————————————
[2]
——————————————————————
http://www.emory.edu/KomenEd/PDF/Treatment/Antineoplastons.pdf
======================================
[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)
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/18/24-1995-10271995-burzynski-to-dr-richard-klausner-7-pgs/
======================================
[0] – Title 18, Part I, Chapter 47, § 1001
——————————————————————
18 USC § 1001 – Statements or entries generally
——————————————————————
http://www.law.cornell.edu/uscode/text/18/1001
======================================
[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/
======================================
[G] – 1991 (12/2/1991) – NCI Decision Network Report on Antineoplastons:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/17/6-1991-12291-nci-decision-network-report-on-antineoplastons/
======================================
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:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
======================================

Advertisements

Critiquing: Aetna: Antineoplaston Therapy and Sodium Phenylbutyrate

[1] – Aetna, Clinical Policy Bulletin: Number: 0240 Policy claims:

Aetna considers antineoplaston therapy (auto-urine therapy) and associated medical services experimental and investigational because there is insufficient evidence published in the peer-reviewed medical literature validating the effectiveness of antineoplaston therapy for any indication“
====================================
Interestingly, the above “claim” does NOT provide any specific citation(s), reference(s), or link(s) to support this claim

[2] – “auto-urine therapy” is generally defined as using one’s own urine, drinking urine, etc., which is NOT what “antineoplaston therapy” is, according to the National Cancer Institute (NCI) at the National Institutes of Health (NIH)
——————————————————————
[3] – 10/4/1991 – Five doctors (3 from the Cancer Therapy Evaluation Branch (CTEP); including the Head of the Quality Assurance and Compliance Section, Regulatory Affairs Branch, Cancer Therapy Evaluation Program, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, and 2 invited consultants; including one from the National Institutes of Health (NIH) Clinical Center) visited the offices of Dr. Stanislaw R. Burzynski
——————————————————————
[4] – 10/31/1991 – Michael A. Friedman, M.D. Associate Director, Cancer Therapy Evaluation Program (CTEP), Department of Health &Human Services, National Institutes of Health, National Cancer Institute, sent a one page Memorandum to Bruce A. Chabner, M.D., Director, Division of Cancer Treatment, which stated, in part:

“I thought you would be interested in this for several reasons:”

“3. Antineoplastons deserve a closer look”

“It turns out that the agents are well defined, pure chemical entities
=======================================
=======================================
“The human brain tumor responses are real”

20130911-102213.jpg
=======================================
[5] – 11/15/1991 – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, sent a 7 page letter to Decision Network, which stated, in part, on page one:
=======================================
=======================================
“It was the opinion of the site visit team that antitumor activity was documented in this best case series … “

20130911-122216.jpg
=======================================
[6] – 12/2/91 – NCI (National Cancer Institute), Decision Network Report on Antineoplastons, states in part, on page 11:

20130911-134634.jpg
=======================================
“The site visit team determined that antitumor activity was documented in this best case series … “
=======================================
=======================================
[7] – CANCER FACTS
National Cancer Institute • National Institutes of Health Department of Health and Human Services, Antineoplastons, pg. 1

=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “

20130911-094155.jpg
=======================================
[8] – Page 1 of 6, BlueCross BlueShield of Alabama, Antineoplaston Cancer Therapy, Policy #: 280, Category: Medicine, states, in part, on page 2 of 6:

Key Points:
=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “
=======================================
=======================================
[9] – ANTINEOPLASTON THERAPY, HS-183, pg. 2
=======================================
=======================================
“After the reviewers found some evidence of antitumor activity … “
=======================================
=======================================
These facts indicate to me that Aetna’s claim about “antineoplastons”, is “debatable”

Maybe they should have learned how to use the Freedom of Information Act (FOIA)
=======================================
REFERENCES:
=======================================
[1]
——————————————————————
http://www.aetna.com/cpb/medical/data/200_299/0240.html
=======================================
[2]
——————————————————————
http://m.cancer.gov/topics/CAM/antineoplastons/Patient
——————————————————————
http://cancer.gov/topics/CAM/antineoplastons/Patient
——————————————————————
http://cancer.gov/topics/CAM/antineoplastons/Patient?print=1
——————————————————————
http://m.cancer.gov/topics/CAM/antineoplastons/Patient?print=1
=======================================
[7]
——————————————————————
http://www.emory.edu/KomenEd/PDF/Treatment/Antineoplastons.pdf
=======================================
[8]
——————————————————————
https://www.bcbsal.org/providers/policies/final/280.pdf
=======================================
[9]
——————————————————————
https://www.wellcare.com/WCAssets/corporate/assets/HS183_Antineoplaston_Therapy.pdf
=======================================

Critiquing: Cancer Research UK What we know about antineoplastons

[1] – Cancer Research UK claims:

“Some people promote antineoplaston therapy as a cancer treatment

“But available scientific evidence does not support claims that antineoplaston therapy is effective in treating or preventing cancer

” Although Dr Burzynski’s own clinic have reported positive results for these trials, no other researchers have been able to show that this type of treatment helps to treat cancer
====================================
Interestingly, the above “claim” does NOT provide any specific citation(s), reference(s), or link(s) to support this claim
——————————————————————
[2] – 10/4/1991 – Five doctors (3 from the Cancer Therapy Evaluation Branch (CTEP); including the Head of the Quality Assurance and Compliance Section, Regulatory Affairs Branch, Cancer Therapy Evaluation Program, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, and 2 invited consultants; including one from the National Institutes of Health (NIH) Clinical Center) visited the offices of Dr. Stanislaw R. Burzynski
——————————————————————
[3] – 10/31/1991 – Michael A. Friedman, M.D. Associate Director, Cancer Therapy Evaluation Program (CTEP), Department of Health &Human Services, National Institutes of Health, National Cancer Institute, sent a one page Memorandum to Bruce A. Chabner, M.D., Director, Division of Cancer Treatment, which stated, in part:

“I thought you would be interested in this for several reasons:”

“3. Antineoplastons deserve a closer look”

“It turns out that the agents are well defined, pure chemical entities
=======================================
=======================================
“The human brain tumor responses are real”

20130911-102213.jpg
=======================================
[4] – 11/15/1991 – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, sent a 7 page letter to Decision Network, which stated, in part, on page one:
=======================================
=======================================
“It was the opinion of the site visit team that antitumor activity was documented in this best case series … “

20130911-122216.jpg
=======================================
[5] – 12/2/91 – NCI (National Cancer Institute), Decision Network Report on Antineoplastons, states in part, on page 11:
=======================================
=======================================
“The site visit team determined that antitumor activity was documented in this best case series … “

20130911-134634.jpg
=======================================
[6] – CANCER FACTS
National Cancer Institute • National Institutes of Health Department of Health and Human Services, Antineoplastons, pg. 1

=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “

20130911-094155.jpg
=======================================
[7] – Page 1 of 6, BlueCross BlueShield of Alabama, Antineoplaston Cancer Therapy, Policy #: 280, Category: Medicine, states, in part, on page 2 of 6:

Key Points:
=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “
=======================================
=======================================
[8] – ANTINEOPLASTON THERAPY, HS-183, pg. 2
=======================================
=======================================
“After the reviewers found some evidence of antitumor activity … “
=======================================
=======================================
These facts indicate to me that Cancer Research UK’s claim about “antineoplastons”, is “debatable”

Maybe they should have learned how to use the Freedom of Information Act (FOIA)
=======================================
REFERENCES:
=======================================
[1]
——————————————————————
http://www.cancerresearchuk.org/cancer-help/about-cancer/cancer-questions/what-is-antineoplaston-therapy
=======================================
[6]
——————————————————————
http://www.emory.edu/KomenEd/PDF/Treatment/Antineoplastons.pdf
=======================================
[7]
——————————————————————
https://www.bcbsal.org/providers/policies/final/280.pdf
=======================================
[8]
——————————————————————
https://www.wellcare.com/WCAssets/corporate/assets/HS183_Antineoplaston_Therapy.pdf
=======================================
Burzynski: Japan antineoplaston publications:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/02/19/burzynski-japan/
=======================================
Burzynski: China antineoplaston publications:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-china-antineoplaston-publications/
=======================================

Critiquing: Wikipedia – Burzynski Clinic

[1] – Wikipedia, claims:
——————————————————————
“There is a scientific consensus that antineoplaston therapy is unproven and of little promise in treating cancer””
——————————————————————
“… a Mayo Clinic study found no benefit from antineoplaston treatment.[1]””
——————————————————————
“The Memorial Sloan-Kettering Cancer Center has stated: “Bottom Line: There is no clear evidence to support the anticancer effects of antineoplastons in humans.”[1]””
——————————————————————
Interestingly, the above 1st claim by “Wikipedia” does NOT provide any specific citation(s), reference(s), or link(s) to support this claim
——————————————————————
[2] – 2/1999 – What “Wikipedia” does NOT advise the reader about the 2nd and 3rd claims, is that the conclusion of the study was:

“Although we could not confirm any tumor regression in patients in this study, the small sample size precludes definitive conclusions about treatment efficacy
——————————————————————
[3] – 6/1999 – Wikipedia also does NOT point out that Burzynski replied to the 2/1999 publication, that:

[A] – Study tested dosing regimen known to be ineffective

[B] – Dosages of A10 and AS2–1 used in study were meant for treatment of single small lesion (<5 cm)

5 of the 6 evaluable patients had either multiple nodules or tumors larger than 5 cm

[C] – As the provider of A10 and AS2–1, I strongly suggested to the National Cancer Institute (NCI) that these patients receive a much higher dose, consistent with greater tumor load

[D] – Study was closed when I insisted the NCI either increase the dosage or inform the patients that the drug manufacturer believed that the treatment was unlikely to be effective at the dosages being used
(letter to Dr M. Sznol, NCI, on 4/20/1995)

[E] – Review of clinical data in the article by Buckner et al proves validity of my position

[F] – Study patients had extremely low plasma antineoplaston levels

My phase 2 study dosage regimen produced plasma phenylacetylglutamine (PG) levels 35 times greater, phenylacetylisoglutamine (isoPG) levels 53 times greater, and phenylacetate (PN) levels 2 times greater than those reported by Buckner et a1 [1]

[G] – Clinical outcomes reported by Buckner et al, based on inadequate dosage schedule, differ dramatically from my phase 2 studies in which higher dosage regimen was used

[H] – They reported no tumor regression

In contrast, in 1 of my ongoing studies on protocol BT-9, 4 of 8 evaluable patients with astrocytoma had objective responses [2]

[I] – Difference in outcomes primarily due to difference in dosage schedules

[J] – Another factor that may have caused a lack of response in the study by Buckner et al is duration of treatment was too brief

Almost all patients in their study received treatment for less than 30 days

1 patient received only 9 days of treatment

Current studies indicate objective tumor responses usually observed after 3 months of therapy

Additional 8 months of treatment usually needed to obtain maximal therapeutic effect

[K] – Ambiguities in response evaluation and analysis in article by Buckner et al

In.2 patients, tumor necrosis attributed to “radio-necrosis”

Interpretation’s clouded by fact antineoplaston-induced necrosis can be indistinguishable from radionecrosis

[L] – Analysis by Buckner et al could’ve highlighted 2 patients with recurrent glioblastoma who survived for more than 1 year

This is of interest because patients typically have life expectancy of 3 to 6 months

[M] – At time of the study by Buckner et al, the sponsor, NCI, decided against higher dosing regimen I proposed and closed the study

Study used dosing regimen known to be ineffective
======================================
[4] – 10/4/1991 – Five doctors (3 from the Cancer Therapy Evaluation Branch (CTEP); including the Head of the Quality Assurance and Compliance Section, Regulatory Affairs Branch, Cancer Therapy Evaluation Program, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, and 2 invited consultants; including one from the National Institutes of Health (NIH) Clinical Center) visited the offices of Dr. Stanislaw R. Burzynski
——————————————————————
[5] – 10/31/1991 – Michael A. Friedman, M.D. Associate Director, Cancer Therapy Evaluation Program (CTEP), Department of Health &Human Services, National Institutes of Health, National Cancer Institute, sent a one page Memorandum to Bruce A. Chabner, M.D., Director, Division of Cancer Treatment, which stated, in part:

“I thought you would be interested in this for several reasons:”

“3. Antineoplastons deserve a closer look”

“It turns out that the agents are well defined, pure chemical entities
=======================================
=======================================
“The human brain tumor responses are real”

20130911-102213.jpg
=======================================
[6] – 11/15/1991 – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, sent a 7 page letter to Decision Network, which stated, in part, on page one:
=======================================
=======================================
“It was the opinion of the site visit team that antitumor activity was documented in this best case series … “

20130911-122216.jpg
=======================================
[7] – 12/2/91 – NCI (National Cancer Institute), Decision Network Report on Antineoplastons, states in part, on page 11:
=======================================
=======================================
“The site visit team determined that antitumor activity was documented in this best case series … “

20130911-134634.jpg
=======================================
[8] – CANCER FACTS
National Cancer Institute • National Institutes of Health Department of Health and Human Services, Antineoplastons, pg. 1

=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “

20130911-094155.jpg
=======================================
[9] – Page 1 of 6, BlueCross BlueShield of Alabama, Antineoplaston Cancer Therapy, Policy #: 280, Category: Medicine, states, in part, on page 2 of 6:

Key Points:
=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “
=======================================
=======================================
[10] – ANTINEOPLASTON THERAPY, HS-183, pg. 2
=======================================
=======================================
“After the reviewers found some evidence of antitumor activity … “
=======================================
=======================================
These facts indicate to me that Wikipedia’s claim about “antineoplastons”, is “debatable”

Maybe they should have learned how to use the Freedom of Information Act (FOIA)
=======================================
REFERENCES:
=======================================
[1]
——————————————————————
http://en.wikipedia.org/wiki/Burzynski_Clinic
——————————————————————
http://en.m.wikipedia.org/wiki/Burzynski_Clinic
——————————————————————
Antineoplastons, Memorial Sloan-Kettering Cancer Center
======================================
[2] – 2/1999 – A10 and AS2-1 – Phase II
Mayo Clinic Proceedings
http://www.ncbi.nlm.nih.gov/m/pubmed/10069350
Phase II Study of Antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in Patients With Recurrent Glioma

Material & Methods:

Patients received escalating doses of A10 and AS2-1 by multiple intermittent intravenous injections with use of portable programmable pump to the target daily dose of 1.0 g/kg for A10 and of 0.4 g/kg for AS2-1

Mean steady-state plasma concentrations of phenylacetate & phenylacetylglutamine after escalation to the target doses of A10 and AS2-1 were 177 +/-101 ug/mL & 302 +/- 102 ug/mL, respectively

Results:

9 patients were treated, in 6 of whom treatment response was assessable in accordance with protocol stipulations
http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)63835-4
Comment in Jun; 74 (6): 641-2
http://www.sciencedirect.com/science/article/pii/S0025619611638354
Mayo Clin Proc 74(2):9 (1999), PMID .10069350
http://www.mayoclinicproceedings.org/article/S0025-6196(11)63835-4/fulltext
DOI: 10.4065/74.2.137
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS0025619611638354.pdf
Mayo Clin Proc 1999; 74: 137–145
http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.2003.01098.x/full
Mayo Clin Proc 1999; 74: 137–45
http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.2003.01098.x/references
J C Buckner, M G Malkin, E Reed, T L Cascino, J M Reid, M M Ames, W P Tong, S Lim, W D Figg
http://onlinelibrary.wiley.com/store/10.1046/j.1365-2796.2003.01098.x/asset/j.1365-2796.2003.01098.x.pdf?v=1&t=hbs6xce2&s=3423e3cd1955667e8e8cdf33323faf0bd85b6a29
Department of Oncology, Mayo Clinic Rochester, Minnesota USA
http://onlinelibrary.wiley.com/store/10.1046/j.1365-2796.2003.01098.x/asset/j.1365-2796.2003.01098.x.pdf?v=1&t=hbrndkdf&s=e0af2d3bfb13841852d92a839d3a4932a5f4bb48
======================================
[3] – 6/1999 – A10 and AS2-1
http://www.ncbi.nlm.nih.gov/pubmed/10377942
Efficacy of antineoplastons A10 and AS2-1
http://www.ncbi.nlm.nih.gov/m/pubmed/10377942
S R Burzynski
Mayo Clin Proc 74 (6): 641-2 (1999),
Mayo Clin Proc. 1999 Jun; 74 (6): 641-2
http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)64143-8
Comment on
Mayo Clin Proc. 1999 Feb; 74 (2): 137-45 PMID .10377942
http://www.mayoclinicproceedings.org/article/S0025-6196(11)64143-8/fulltext
Mayo Clin Proc. 1999
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS0025619611641438.pdf
Comment on
Mayo Clinic Proc. 1999; 74: 641–642 (letter)
http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)64143-8
Mayo Clin Proc
74 (6): 641-2
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS0025619611641438.pdf
Mayo Clin Proc 74 (6): 1 (1999),
Elsevier Ltd.
DOI: 10.4065/74.6.641
1999 – A10 and AS2-1 – Mayo
Buckner, Reid, & Malkin
Mayo Clin Proc 74 (6): 2 (1999),
Elsevier Ltd.
DOI: 10.4065/74.6.641-a
http://www.mayoclinicproceedings.org/article/S0025-6196(11)64144-X/fulltext
Mayo Clinic Proceedings
74(6):2 1999 Elsevier Ltd.
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS002561961164144X.pdf
=======================================
[8]
——————————————————————
http://www.emory.edu/KomenEd/PDF/Treatment/Antineoplastons.pdf
=======================================
[9]
——————————————————————
https://www.bcbsal.org/providers/policies/final/280.pdf
=======================================
[10]
——————————————————————
https://www.wellcare.com/WCAssets/corporate/assets/HS183_Antineoplaston_Therapy.pdf
=======================================

Critiquing: Memorial Sloan-Kettering Cancer Center (MSKCC)

[1]Memorial Sloan-Kettering Cancer Center (MSKCC), How It Works,, claims:

”Bottom Line: There is no clear evidence to support the anticancer effects of antineoplastons in humans”
——————————————————————
Interestingly, the above “Bottom Line” does NOT provide any specific citation(s), reference(s), or link(s) to support this claim
——————————————————————
[2] – 10/4/1991 – Five doctors (3 from the Cancer Therapy Evaluation Branch (CTEP); including the Head of the Quality Assurance and Compliance Section, Regulatory Affairs Branch, Cancer Therapy Evaluation Program, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, and 2 invited consultants; including one from the National Institutes of Health (NIH) Clinical Center) visited the offices of Dr. Stanislaw R. Burzynski
——————————————————————
[3] – 10/31/1991 – Michael A. Friedman, M.D. Associate Director, Cancer Therapy Evaluation Program (CTEP), Department of Health &Human Services, National Institutes of Health, National Cancer Institute, sent a one page Memorandum to Bruce A. Chabner, M.D., Director, Division of Cancer Treatment, which stated, in part:

“I thought you would be interested in this for several reasons:”

“3. Antineoplastons deserve a closer look”

“It turns out that the agents are well defined, pure chemical entities
=======================================
=======================================
“The human brain tumor responses are real”

20130911-102213.jpg
=======================================
[4] – 11/15/1991 – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, sent a 7 page letter to Decision Network, which stated, in part, on page one:
=======================================
=======================================
“It was the opinion of the site visit team that antitumor activity was documented in this best case series … “

20130911-122216.jpg
=======================================
[5] – 12/2/91 – NCI (National Cancer Institute), Decision Network Report on Antineoplastons, states in part, on page 11:
=======================================
=======================================
“The site visit team determined that antitumor activity was documented in this best case series … “

20130911-134634.jpg
=======================================
[6] – CANCER FACTS
National Cancer Institute • National Institutes of Health Department of Health and Human Services, Antineoplastons, pg. 1

=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “

20130911-094155.jpg
=======================================
[7] – Page 1 of 6, BlueCross BlueShield of Alabama, Antineoplaston Cancer Therapy, Policy #: 280, Category: Medicine, states, in part, on page 2 of 6:

Key Points:
=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “
=======================================
=======================================
[8] – ANTINEOPLASTON THERAPY, HS-183, pg. 2
=======================================
=======================================
“After the reviewers found some evidence of antitumor activity … “
=======================================
=======================================
These facts indicate to me that Memorial Sloan-Kettering Cancer Center’s (MSKCC) claim about “antineoplastons”, is “debatable”

Maybe they should have learned how to use the Freedom of Information Act (FOIA)
=======================================
REFERENCES:
=======================================
[1]
——————————————————————
http://www.mskcc.org/cancer-care/herb/antineoplaston
=======================================
[6]
——————————————————————
http://www.emory.edu/KomenEd/PDF/Treatment/Antineoplastons.pdf
=======================================
[7]
——————————————————————
https://www.bcbsal.org/providers/policies/final/280.pdf
=======================================
[8]
——————————————————————
https://www.wellcare.com/WCAssets/corporate/assets/HS183_Antineoplaston_Therapy.pdf
=======================================

Critiquing: American Cancer Society – Antineoplaston Therapy

[1] – The American Cancer Society Antineoplaston Therapy Overview claims:
=====================================
=====================================
” In other words, there is no convincing evidence showing that antineoplastons actually work
=====================================
=====================================
====================================
Interestingly, the above Overview does NOT provide any specific citation(s), reference(s), or link(s) to support this claim
——————————————————————
[2] – 10/4/1991 – Five doctors (3 from the Cancer Therapy Evaluation Branch (CTEP); including the Head of the Quality Assurance and Compliance Section, Regulatory Affairs Branch, Cancer Therapy Evaluation Program, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, and 2 invited consultants; including one from the National Institutes of Health (NIH) Clinical Center) visited the offices of Dr. Stanislaw R. Burzynski
——————————————————————
[3] – 10/31/1991 – Michael A. Friedman, M.D. Associate Director, Cancer Therapy Evaluation Program (CTEP), Department of Health &Human Services, National Institutes of Health, National Cancer Institute, sent a one page Memorandum to Bruce A. Chabner, M.D., Director, Division of Cancer Treatment, which stated, in part:

“I thought you would be interested in this for several reasons:”

“3. Antineoplastons deserve a closer look”

“It turns out that the agents are well defined, pure chemical entities
=======================================
=======================================
“The human brain tumor responses are real”

20130911-102213.jpg
=======================================
[4] – 11/15/1991 – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, sent a 7 page letter to Decision Network, which stated, in part, on page one:
=======================================
=======================================
“It was the opinion of the site visit team that antitumor activity was documented in this best case series … “

20130911-122216.jpg
=======================================
[5] – 12/2/91 – NCI (National Cancer Institute), Decision Network Report on Antineoplastons, states in part, on page 11:
=======================================
=======================================
“The site visit team determined that antitumor activity was documented in this best case series … “

20130911-134634.jpg
=======================================
[6] – CANCER FACTS
National Cancer Institute • National Institutes of Health Department of Health and Human Services, Antineoplastons, pg. 1

=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “

20130911-094155.jpg
=======================================
[7] – Page 1 of 6, BlueCross BlueShield of Alabama, Antineoplaston Cancer Therapy, Policy #: 280, Category: Medicine, states, in part, on page 2 of 6:

Key Points:
=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “
=======================================
=======================================
[8] – ANTINEOPLASTON THERAPY, HS-183, pg. 2
=======================================
=======================================
“After the reviewers found some evidence of antitumor activity … “
=======================================
=======================================
These facts indicate to me that the American Cancer Society’s claim about “antineoplastons”, is “debatable”

Maybe they should have learned how to use the Freedom of Information Act (FOIA)
=======================================
REFERENCES:
=======================================
[1]
——————————————————————
http://m.cancer.org/treatment/treatmentsandsideeffects/complementaryandalternativemedicine/pharmacologicalandbiologicaltreatment/antineoplaston-therapy
=======================================
[6]
——————————————————————
http://www.emory.edu/KomenEd/PDF/Treatment/Antineoplastons.pdf
=======================================
[7]
——————————————————————
https://www.bcbsal.org/providers/policies/final/280.pdf
=======================================
[8]
——————————————————————
https://www.wellcare.com/WCAssets/corporate/assets/HS183_Antineoplaston_Therapy.pdf
=======================================