Critiquing: The Institute of Medicine report on cancer care: Is the system “in crisis”?

[1] – 9/19/2013 – “Americans love to fight, traditionally”

“All real Americans love the sting and clash of battle…When you, here, everyone of you, were kids, you all admired the champion marble player, the fastest runner, the toughest boxer, the big league ball players, and the All-American football players”

“Americans love a winner”

“Americans will not tolerate a loser”

– General George S. Patton, Jr., June.5, 1944

The above might as well be Greek to Dr. David H. Gorski a/k/a “Orac”

He’s the epitome of the word “loser”

Indeed, “Orac” described his work-place nemesis as “user hostile”

After 5 years, he still didn’t fully understand much of it, and he claims he’s not exactly computer illiterate

Gorski is that “guy” who couldn’t even find Burzynski’s publication:

[2] – 1997 – Burzynski. S.R. Antineoplastons. oncogenes and cancer

[3] – “Orac” batted the big “O” when he tried to find “the scientific rationale to expect that” antineoplastons “might have antitumor activity”

[4] – Gorski was geniusless when it came to finding “which genes are targeted by antineoplastons,“ proving that he really does NOT know Burzynski’s personalized gene-targeted therapy

In fairness, I will point out that he hasn’t put the time in to learn all the ins and outs of the system …

He pontidefecates about phase II clinical trials when his name isn’t even on a phase 2 trial, too

[5] – 9/19/2013 – He’s the “guy” who’s “mystified” as to how Stanislaw Burzynski “has managed to keep practicing for 36 years after he first began treating patients with an unapproved (not ordinary) chemotherapeutic drug (the concoction of peptides purportedly isolated from blood and urine that Burzynski dubbed “antineoplastons” because of their alleged ability to inhibit the growth of cancer)”

This is not an issue unique to Gorski; I’ve discussed other cases like this, such as Bobby Blaskiewicz, who used his man-crush relationship with Gorski to appear on the Skeptic Canary Show; Davey James, who was only recently stripped of his license to practice in several states of mind; Adam Jacobs, who went so far as to use his business influence to alter his Dianthus Mediclueless web-site in London to be more hack friendly, and an interventist who administered twerkpidity to posers who didn’t have common sense and defrauded minions for tens of millions of minutia

It’s a general problem

However, as far as doctors who should have been shut down a long time ago, “Orac” takes the cake

[6] – He has NOT yet figured out that Burzynski learned from the best

[7] – Who could do it better than someone like Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH) who Burzynski had to deal with:

“This is, as you point out, a most serious matter, and I was hoping that you could allay my concerns by showing me where they are unfounded

“However, your letter conspicuously fails to address them

“You also make reference to “numerous factual misstatements” but fail to identify any of them, much less provide documentation to show they are false”

Pg. 2

“I am glad that you plan to “thoroughly examine the accusations” I have made”

“I also eagerly await a substantiative response to the points raised in my letter of 4/20/1995”

20130920-220216.jpg

20130920-220507.jpg
After all, can we really take a person seriously, who claimed:
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[8] – 11/2/2012 – “Personally, having pored over Burzynski’s publications … “
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[9] – 5/8/2013 – “I’ve searched Burzynski’s publications … “
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[10] – 6/5/2013 – “ … I do know cancer science”
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Uhhhhhhh … yeah

But do you really know Burzynski’s cancer science when you did NOT even know:

“which genes are targeted by antineoplastons“?

Has “GOraCON” (“Orac” + @Gorskon) even read these ?
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[11] – 10/2003 – Waldbillig R, Burzynski SR. Mechanism of action, uptake, and gene array studies on the antineoplastic agent phenylacetylglutamine (PG) in human glioma cells U-87. Neuro-Oncology. 2003; 5: 309

Volume 5 Issue 4 October 2003

(genes CD38, OASL, and TCF8)
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[12] – 10/2007 – Patil, S., Burzynski, S.R., Mrowczynski, E., Grela, K. Phenylacetylglutamine (PG) and phenylacetate (PN) interact additively to produce detachment-induced apoptosis/anoikis in glioblastoma cells. Neuro-Oncology 2007; 9:482

Volume 9 Issue 4 October 2007

We have conducted a total human gene array screen using the Affymetrix Human Genome plus 2.0 oligonucleotide arrays, for genes regulated by PG and a combination of PG and PN

gene TXNIP was up-regulated almost 5-fold with PG, and almost 120-fold using a combination of PG and PN

genes that are significantly up-regulated are CLDND1, ATF3, CASP5, TP53, TRIB3, and UNC5B

Genes that were down-regulated include AKT2, ASPM, CDCA8

(caspase 5, p53, netrin receptor) and AKT pathway (AKT2, TRB3)
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[13] – 10/2008 – Patil, S., Burzynski, S., Chittur, S., Mrowczynski, E., Grela, K. Antineoplaston AS2-1 affects cell cycle checkpoints, leading to apoptosis in human glioblastoma cells. Neuro-Oncology 2008; 10:786

Volume 10 Issue 5 October 2008

Affymetrix Human Genome

CDCs 25A and 25B, cyclins D3 and E, and CDKs 3, 4, and 6

ORC1L and CDC6

MCMs 2, 3, 4, 5, 6, and 7, and CDC7

cyclins A, B1, and B2, polykinase 1, and CDKs 1 and 2

MAD2L1, BUB1 and CDC20

p21, p53, and GADD45A

p21/CDKN1A, and PPM1A

Based on pathway analysis, it was observed that anti-neoplastons affected the expression of more than 40 genes instrumental in the cell cycle in GBM cells
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[14] – 12/2008 – Patil, S., Burzynski, S., Chittur, S., Mrowczynski, E., Grela, K. The ingredients of antineoplaston AS2-1 down-regulate glycolysis pathways in glioblastoma cells. Neuro-Oncology 2008; 10:1148

Volume 10 Issue 6 December 2008

In 2004 the FDA granted orphan drug designation for antineoplastons A10 and AS2-1 for the treatment of brainstem glioma

12 FDA-supervised phase II clinical trials have confirmed anti-tumor efficacy in several types of brain tumors

A total human gene array screen using the Affymetrix Human Genome

The expression of mRNA for vitamin D3 up-regulated protein 1 (VDUP1) was found to be over 100 fold higher for cells treated with PG and PN

succinate dehydrogenase C (SDHC), fumarate hydrogenase (FH), succinate-CoA ligase 1 and 2 (SUCLG1and 2), and aconitase 2 (ACO2)
——————————————————————
[15] – 11/2010 – Patil S, Burzynski SR, Mrowczynski E, Grela K. Targeting MicroRNAs in Glioma Cells with Antineoplastons. Neuro-Oncology 2010; 12, iv10

Volume 12 Supplement 4 November 2010

This study was done using the Dharmacon mRNA profiling array (Thermo Fisher Scientific)

mRNAs 125a-5p and 125a-3p

mRNAs 125a-5p has recently been shown to be regulated by the epidermal growth factor receptor and to function as a tumor suppressor in lung cancer

It has also been shown that the over-expression of mRNA 125a or mRNA 125b caused reduced migration and invasion of SKBR3 breast cancer cells

Using the total human microarray screen (Affymetrix)

AKT2
——————————————————————
[16] – 6/2012 – Sonali, S. Patil, Stanislaw R. Burzynski, Emilia Mrowczynski, Krzysztof Grela, Sridar V. Chittur. Phenylacetylglutaminate and Phenylacetate in combination Upregulate VDUP1, cause cell cycle blockade and Apoptosis in U87 Glioblastoma cells. Journal of Cancer Therapy 2012;3:192-200
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[17] – 9/2012 – Patil, S., Burzynski S.R., Mrowczynski, E., Grela, K. P.003. Phenylacetylglutaminate in combination with Phenylbutyrate effectively inhibits growth of brain tumor cell In Vitro. Neuro-Oncology 2012;14(Suppl. 3):iii16

Volume 14 Supplement 3 September 2012

The FDA granted Orphan Drug designation for Antineoplastons A10 and AS2-1 for the treatment of gliomas, in 2009

12 FDA-supervised Phase II clinical trials have confirmed anti-tumor efficacy in several types of brain tumor

AKT2

PG is not toxic to normal cells whereas PB has dose-limiting neuro-cortical toxicity
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Cancer care: Is the system “in crisis” ?

The Institute of Medicine, just in case you’re like “Orac” and have NOT yet figured it out, “the system” has been “in crisis” since the Gubment “forgot” who they are here to serve

[18] – Gorsi, maybe you can explain to The Institute of Medicine why the Cancer care system is “in crisis” because M.D.’s with Ph.D’s who hold positions “at an NCI-designated comprehensive cancer center,”are responsible for massive fact-checking #FAILS

What did you do, Gorski ?

Phone It in again ?
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REFERENCES:
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[1] – 9/19/2013 – The Institute of Medicine report on cancer care: Is the system “in crisis” ?
——————————————————————
http://scienceblogs.com/insolence/2013/09/19/the-institute-of-medicine-report-on-cancer-care-is-the-system-in-crisis/
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[2] – 1997 – Critiquing: Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies:
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https://stanislawrajmundburzynski.wordpress.com/2013/07/26/x/
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[3] – Critiquing: Dr. David H. “Orac” Gorski and The Skeptics™
http://www.scienceblogs.com/Insolence
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/08/critiquing-dr-david-h-orac-gorski-and-the-skeptics/
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[4] – Critiquing: Dr. David H. “Orac” Gorski, M.D., Ph.D, L.I.A.R.:
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https://stanislawrajmundburzynski.wordpress.com/2013/08/07/critiquing-dr-david-h-orac-gorski-m-d-ph-d-l-i-a-r/
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[5] – 9/19/2013 – Another case of the failure of physician regulation endangering patients
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http://scienceblogs.com/insolence/2013/09/19/another-case-of-the-failure-of-physician-regulation-endangering-patients/
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[6] – 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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DID Dr. Michael A. Friedman FIB?:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/18/did-dr-michael-a-friedman-fib/
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Dr. Michael A. Friedman, DATA ?:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/19/dr-michael-a-friedman-data/
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Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet “fact sheet”:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/19/critiquing-national-cancer-institute-nci-at-the-national-institutes-of-health-nih-cancernet/
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[8] – 11/.2/2012
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http://scienceblogs.com/insolence/2012/11/02/stanislaw-burzynski-fails-to-save-another-patient/
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[9] – 5/8/2013
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http://scienceblogs.com/insolence/2013/05/08/eric-merola-and-stanislaw-burzynskis-secret-weapon-against-the-skeptics-fabio-lanzoni-part-2/
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[10] – 6/5/2013
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http://scienceblogs.com/insolence/2013/06/05/odds-and-ends-about-burzynski-clinic/
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[11] – 10/2003
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http://www.burzynskiclinic.com/images/stories/Publications/971.pdf
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[12] – 10/2007
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http://www.burzynskiclinic.com/images/stories/Publications/5169.pdf
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[13] – 2008
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http://www.burzynskiclinic.com/images/stories/Publications/7854.pdf
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[14] – 2008
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http://www.burzynskiclinic.com/images/stories/Publications/7897.pdf
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[15] – 11/2010
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http://www.burzynskiclinic.com/images/stories/Publications/8636.pdf
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[16] – 6/2012
——————————————————————
http://www.burzynskiclinic.com/images/stories/Publications/9219.pdf
——————————————————————
Journal of Cancer Therapy, 2012, 3, 192-200
doi:10.4236/jct.2012.33028 Published Online June 2012
5. Acknowledgements
This study was supported by and carried out at the Burzynski research Institute (BRI), Houston TX, USA. The Microarray assay was supported by BRI and carried out at Center for Functional Genomics, University of Albany, NY, USA
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[17] – 9/2012
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http://www.burzynskiclinic.com/images/stories/Publications/9291.pdf
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http://www.burzynskiclinic.com/scientific-publications.html
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[18] – Wayne State University, Detroit, Michigan, quickly realized that David H. Gorski, MD, PhD, FACS is NOT doing something wrong when he LIES about Burzynski:
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https://stanislawrajmundburzynski.wordpress.com/2013/08/27/wayne-state-university-detroit-michigan-quickly-realized-that-david-h-gorski-md-phd-facs-is-not-doing-something-wrong-when-he-lies-about-burzynski/
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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
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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
——————————————————————
[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)
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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
======================================
[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
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[1] – Date Last Modified 10/1995
——————————————————————

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
——————————————————————

20130919-174650.jpg

20130919-174914.jpg
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[2]
——————————————————————
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)
——————————————————————
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
======================================
[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/
======================================

Does David H. “Orac” Gorski, M.D., Ph.D, really CARE about Breast Cancer patients?

Dr. Gorski (@gorskon @OracKnows @ScienceBasedMed
http://www.scienceblogs.com/Insolence
#ScienceBasedMedicine
http://www.sciencebasedmedicine.org)
is advertised as being a “Breast Cancer Specialist”

The question is, does he really CARE about Breast Cancer patients?

2000-2001, clinical studies were conducted on breast cancer patients in Egypt, using antineoplaston A10
======================================
Burzynski: Egypt antineoplaston publications:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-egypt-antineoplaston-publication/
======================================
7/3/2000 they noted:
——————————————————————
Antineoplastons first described by Burzynski are naturally occurring peptides and amino acid derivatives, which control neoplastic growth
——————————————————————
Antineoplaston A-10 level measured in urine of:
31 breast cancer patients
17 normal women
——————————————————————
Significantly lower antineoplaston A-10 levels detected among patients with breast cancer
——————————————————————
Data suggest strong inverse association of urinary antineoplaston A-10 level with breast cancer
——————————————————————
Potential utility of antineoplaston A-10 as predictive test for women at risk of developing breast cancer
======================================
8/31/2000 they noted:
—————————————————————
Antineoplastons are naturally occurring cytodifferentiating agents
—————————————————————
Chemically, they are medium and small sized peptides, amino acid derivatives and organic acids, which exist in blood, tissues and urine
—————————————————————
Findings confirm presence of immune defects among patients with breast cancer and results should stimulate development of new strategies to induce and augment immunity for treatment of breast cancer
—————————————————————
Antineoplaston A-10 may provide rational basis for designing trials to employ its immune modulatory potentials as adjuvant therapy in breast cancer patients
======================================
12/2000 they noted:
—————————————————————
4 new piperidinedione A10 analogs synthesized and tested for antimitotic activity on human breast cancer cell line against prototype A10 and antibreast cancer drug tamoxifen
—————————————————————
DNA binding capacity of compounds evaluated against A10
—————————————————————
“3A” and “3C” had weaker biological profiles than lead compound A10
—————————————————————
“3B” and “3D” were several-fold more potent antiproliferative agents than A10 and tamoxifen and had significantly higher capacity to bind DNA than A10
======================================
10/1/2001 they noted:
—————————————————————
Reports on structural characterization of new antineoplaston (ANP) representatives
—————————————————————
Combination heat with pH modification had virtually no effect on obtained peaks, attesting to stability and purity of compounds
—————————————————————
One had superior affinity to DNA than prototype ANP-A10
======================================
8/2005 Antineoplastons such as A10 include naturally occurring peptides and amino acid derivatives that CONTROL NEOPLASTIC GROWTH OF CELLS
——————————————————————
Findings indicate antineoplaston A10 ANTITUMOR EFFECT could be utilized as effective therapy for breast cancer patients
——————————————————————
Antineoplaston induces G1 arrest by PKCα and MAPK pathway in SKBR-3 breast cancer cells
Hideaki H TSUDA Antineoplaston A10
http://www.ncbi.nlm.nih.gov/pubmed/16012735
Antineoplaston induces G1 arrest by PKCo and MAPK pathway in SKBR-3 breast cancer cells
http://www.ncbi.nlm.nih.gov/m/pubmed/16012735
Antineoplaston induces G(1) arrest by PKCalpha and MAPK pathway in SKBR-3 breast cancer cells
http://www.spandidos-publications.com/or/14/2/489
Oncol Rep. 8/2005; 14(2):489-94
http://gyouseki.kurume-u.ac.jp/PDF/ichiran_2005.pdf
Oncol Rep 14(2):489-94 (2005)
http://research.kurume-u.ac.jp/K90RES.php?scode=49485632873864
Oncol Rep. 2005; 14:489–94
http://onlinelibrary.wiley.com/doi/10.1002/iub.574/abstract
Oncol. Rep. 14, 489–494
http://onlinelibrary.wiley.com/doi/10.1002/iub.574/full
Oncology Reports, 8/2005, Volume 14 Number 2
Pages: 489-494
http://onlinelibrary.wiley.com/store/10.1002/iub.574/asset/574_ftp.pdf?v=1&t=hbr9z60q&s=0b1c1e8655db9c54b45dbf72062e8b11cb7895ac
Oncology Reports, Spandidos Publications
Department of Surgery, Kurume University School of Medicine, Kurume, Fukuoka, Japan
======================================
� � � � � � � � � � � � � � � �
1/2008 Novel mechanism through which all-trans retinoic acid (ATRA) and antineoplaston, ANTICANCER DRUG, CAUSED CELL GROWTH INHIBITION IN BREAST CANCER CELLS through effects on intracellular pathways
——————————————————————
Antineoplaston caused down-regulation of PKCalpha protein expression, resulting in INHIBITION of ERK MAPK phosphorylation, with resultant INHIBITION of Rb phosphorylation leading to G(1) arrest

Preclinical studies of molecular-targeting diagnostic and therapeutic strategies against breast cancer
http://www.ncbi.nlm.nih.gov/pubmed/18224398
antineoplaston
http://www.ncbi.nlm.nih.gov/m/pubmed/18224398
Breast Cancer 15(1):73-8 (2008)
DOI: 10.1007/s12282-007-0015-y
http://link.springer.com/article/10.1007%2Fs12282-007-0015-y
15(1):73-8
http://www.springerlink.com/content/p724x34746l56v73
Department of Surgery, Kurume University, Fukuoka, Japan
http://ci.nii.ac.jp/naid/10021288533
======================================
Burzynski has made it clear that:

… antineoplaston A10 rather than antineoplaston AS2-1 is main active drug
—————————————————————
Pg. 99
—————————————————————
http://www.burzynskiclinic.com/images/stories/Publications/960.pdf
—————————————————————
Burzynski has been using the “Parent” generation of antineoplastons in the phase II clinical trials, and could NOT just switch to new antineoplaston analogs which may produce better results

Also, Burzynski has made it clear that successive generations of antineoplastons have been developed which may also produce better results
—————————————————————
To those who seemed to think Burzynski’s phase II clinical trials were taking too long, he was following science based medicine’s:
—————————————————————
Pg. 94
—————————————————————
2-stage phase II clinical trial design proposed by Fleming [3]
—————————————————————
Pg. 100 References
—————————————————————
3. Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics 1982; 38: 143-51
http://www.ncbi.nlm.nih.gov/pubmed/7082756/
Biometrics. 1982 Mar;38(1):143-51
http://www.ncbi.nlm.nih.gov/m/pubmed/7082756/
Biometrics Vol. 38, No. 1, Mar., 1982
http://www.jstor.org/discover/10.2307/2530297?uid=3739656&uid=2460338175&uid=2460337855&uid=2&uid=4&uid=83&uid=63&uid=3739256&sid=21102549294733
—————————————————————
To those who have made ridiculous statements to the effect that Burzynski is a murderer, and ignore that he has dealt with patients whom science based medicine’s chemotherapy therapy and / or radiation therapy did NOT work, what’s the difference when science based medicine fails?
——————————————————————
33 / 100% – DIED OF DISEASE PROGRESSION
——————————————————————
2004 – Supratentorial high-grade ASTROCYTOMA and DIFFUSE BRAINSTEM GLIOMA:
——————————————————————
two challenges for the pediatric oncologist
http://www.ncbi.nlm.nih.gov/pubmed/15047924/
Oncologist. 2004;9(2):197-206
http://www.ncbi.nlm.nih.gov/m/pubmed/15047924/
Oncologist 9, 197-206
http://m.theoncologist.alphamedpress.org/content/9/2/197.long
Division of Neuro-Oncology, Department of Hematology-Oncology, St. Jude Children’s Research Hospital, Memphis, Tennessee, USA
======================================
David James (@StortSkeptic) tweeted at 7:08pm – 1 Aug 13:

The new Doctor Who will be Stanislaw #Burzynski. He manages to continually avoid getting cornered and he gets away with murder.

—————————————————
To those who say that antineoplastons are toxic, what is the difference with science based medicine’s chemotherapy therapy or radiation therapy when we know that NOT all patients will experience all possible side-effects of a drug?

The successive generations of antineoplastons may be even better and have less potential side-effects
=====================================
10/1/2010 As degradation product of Antineoplaston A10 in vivo, PHENYLACETYL GLUTAMINE showed ANTITUMOR ACTIVITIES
——————————————————————
Designed and radiosynthesized PHENYLACETYL GLUTAMINE derivative, achieved under mild reaction condition
——————————————————————
radiochemical purity of (S)-2-((S)-2-(4-(3-fluoropropyl)benzamido)-3-phenylpropanamido)pentanedioic acid ([18F]FBPPA) was 98%, and best radiochemical yield was up to 46%
——————————————————————
results revealed it might become potential PET imaging agent for DETECTING TUMORS
——————————————————————
Antineoplaston A10 phenylacetyl glutamine (PG) – (S)-2-((S)-2-(4-(3-[18F]fluoropropyl)benzamido)-3-phenylpropanamido)pentanedioic acid labeled with 18F
http://www.springerlink.com/content/tj0177485773007t
(S)-2-((S)-2-(4-(3-[18 F] fluoropropyl) benzamido)-3-phenylpropanamido) pentanedioic acid labeled with 18 F
http://link.springer.com/article/10.1007%2Fs10967-010-0633-2?LI=true
Journal of Radioanalytical and Nuclear Chemistry, 2010, 286, 1, 135
http://www.springerlink.com/content/tj0177485773007t
October 2010, Volume 286, Issue 1, pp 135-140
http://link.springer.com/article/10.1007%2Fs10967-010-0633-2
DOI
10.1007/s10967-010-0633-2
http://link.springer.com/article/10.1007/s10967-010-0633-2/fulltext.html
Burzynski References: 5. – 6.
http://onlinelibrary.wiley.com/doi/10.1021/js960120y/abstract

http://www.springerlink.com/content/tj0177485773007t
======================================
Antineoplastons as a blood or urine “cancer test”:
—————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/02/22/antineoplastons-as-a-blood-or-urine-cancer-test/
======================================

Critiquing: Dr. David H. “Orac” Gorski, M.D., Ph.D, LIAR: Stanislaw Burzynski versus the BBC

Believe in Facts ???

Get out the popcorn !!!
——————————————————————
Dr. David H. “Orac” Gorski is a liar

Let me put that in bold for emphasis

Dr. David H. “Orac” Gorski is a liar

Open wide and say ahhhhhhh …

DR. DAVID H. “ORAC” GORSKI IS A LIAR
——————————————————————
Much better !!!

Some things just look much better when they come in 3’s

And that must be what “Orac” is god thinks, since he seems to live by the the edict of the 3 wise monkeys:
——————————————————————
See No Evil

Hear No Evil

Speak No Evil
——————————————————————
Of course, to Gorski, Evil is any truth which he disagrees with, which he acts like does NOT exist, and obviously can NOT find on the Internet with his Commodore 64, or whatever piece of garbage he’s using, which he must have set to block any websites he wishes to NOT see
——————————————————————
Gorski, the Hypocrite, calls me a “CRANK”, which is especially hilarious, considering how much better my research is than his, without the bias

LIES

Misdirection

Disinformation

Misinformation

MisDisInformation
——————————————————————
David Gorski (@gorskon) tweeted at 3:24am – 14 Jul 13:

@Funkmon @HoracioHornblow Ha ha. It’s the rather pathetic crank Didymus Judas Thomas. That guy couldn’t buy a clue. #Burzynski

——————————————————————
If I wanted to lower myself to Gorski’s level, I could delete comments from my blog
——————————————————————
6/4/2013, Gorski must have evacuated this from deep within his bowels:
� � � � � � � � � � � � � � � �
Stanislaw Burzynski versus the BBC
http://scienceblogs.com/insolence/2013/06/04/stanislaw-burzynski-versus-the-bbc/
� � � � � � � � � � � � � � � �
I was busy at the time reviewing the British Broadcasting Corporation’s Panorama bit on Burzynski:
======================================
6/4/2013

The British are Coming, The British are Coming: Critiquing “Curing cancer or ‘selling hope’ to the vulnerable?”:
https://stanislawrajmundburzynski.wordpress.com/2013/06/04/the-british-are-coming-the-british-are-coming-critiquing-curing-cancer-or-selling-hope-to-the-vulnerable/
======================================
6/7/2013

IT MAY NOT BE SCIENCE: Critiquing “Curing cancer or ‘selling hope’ to the vulnerable?”:
https://stanislawrajmundburzynski.wordpress.com/2013/06/07/it-may-not-be-science-critiquing-curing-cancer-or-selling-hope-to-the-vulnerable/
======================================
But now that I have some time, lets all enjoy Gorski’s LIES

Misdirection

Disinformation

Misinformation

MisDisInformation

While I DISS his MisDisInformation

Since the dates involved are important in exposing Gorski’s LIES, Gorski states:
——————————————————————
“After yesterday’s epic deconstruction of the latest propaganda-fest from … Eric Merola, on his most admired subject, “brave maverick doctor” Stanislaw Burzynski”
——————————————————————
(6/3/2013) in relation to Gorski’s cherry-picked “review” which I critiqued:
======================================
7/18/2013

Critiquing: In which the latest movie about Stanislaw Burzynski “cancer cure” is reviewed…with Insolence:
https://stanislawrajmundburzynski.wordpress.com/2013/07/18/critiquing-in-which-the-latest-movie-about-stanislaw-burzynski-cancer-cure-is-reviewed-with-insolence-2/
======================================
Gorski posits:
——————————————————————
“I needed something science-based to cleanse the rancid taste of intelligence-insulting nonsense from my mind”
——————————————————————
My understanding of Gorski’s definition of #ScienceBasedMedicine is:

1. Visualize a Victim

2. Create biased blogposts utilizing:

a. LIES

b. Misdirection

c. Disinformation

d. Misinformation

e. MisDisInformation

Gorski advises:
——————————————————————
“I was interviewed over the phone by a producer of the show and exchanged e-mails to answer questions”
——————————————————————
I am NOT certain what qualifications BBC Panorama thought that Gorski has in order for him to be interviewed about Burzynski, unless they wanted the perspective of a LIAR

Gorski mentions “False balance”, which readers of his and / or my blog are all too familiar with when it comes to “Orac”

He whines that there is:
——————————————————————
” … zero mention of how Burzynski recently managed to beat an effort by the Texas Medical Board to strip him of his medical license by throwing his employed doctors under the bus …”
——————————————————————
This seems to be:

Misdirection

Disinformation

Misinformation

by Gorski, as anyone can read the case documents:
======================================
Burzynski: Texas Medical Board (TMB) and State Office of Administrative Hearings (SOAH):
https://stanislawrajmundburzynski.wordpress.com/2013/07/18/burzynski-texas-medical-board-tmb-and-state-office-of-administrative-hearings-soah/
======================================
and note that, as Richard A. Jaffe points out, Burzynski was:

1. NOT even in the USA during one of the patients care

2. there was no evidence that Burzynski met either patient

3. Burzynski was NOT the Doctor of Record for either patient

4. If the SOAH had an actual case, they could have gone after the actual Doctors of Record

What Gorski blogs is NOT worth the paper it is NOT written on

EVERYTHING Gorski blogs should be “Fact-Checked” for accuracy

He also ejects:
——————————————————————
” … only the most superficial treatment of how in general it is considered unethical to demand payment from patients to participate in clinical trials”
——————————————————————
though he provides NO basis in FACT for this statement

He also laments:
——————————————————————
“No, and there isn’t any mention of how the Burzynski Clinic waged a campaign of harassment against bloggers who criticized Burzynski back in 2011”
——————————————————————
What Gorski does NOT mention is that:

there isn’t any mention of how the bloggers waged a campaign of harassment against Burzynski

with their:

LIES

Misdirection

Disinformation

Misinformation
======================================
I find Rhys Morgan abnormally prehensile:
https://stanislawrajmundburzynski.wordpress.com/2013/04/20/i-find-rhys-morgan-abnormally-prehensile/
======================================
Gorski cries:
——————————————————————
“Indeed, one of the victims of that harassment, Rhys Morgan, was interviewed by the Panorama crew, but he was informed that his interview was cut from the final version because it didn’t fit the narrative”
——————————————————————
I thought it humorous when The Skeptics™ whined on Twitter that Rhys Morgan wasn’t going to make the cut

What was he going to say ?

How he copied all of his Burzynski blogsplats from other people’s blogs?

Gorski mentions:
——————————————————————
“All you have to do is to read Saul Green’s reports on Quackwatch and in The Cancer Letter from the 1990s”
——————————————————————
Of course, Gorski conveniently forgets to mention Green’s Confict-of-Interest, since Green was associated with a lawsuit against Burzynski

But then again, Gorski seems to have conveniently forgotten his own possible COI, which someone posted a link to on Twitter:
——————————————————————
David Gorski’s Financial PHARMA Ties What He Didn’t Tell You:
http://www.ageofautism.com/2010/06/david-gorskis-financial-pharma-ties-what-he-didnt-tell-you.html
——————————————————————
Gorski fumes:
——————————————————————
“One of them reminded me very much of the conversation with her NHS oncologist that Laura Hymas recorded and allowed Eric Merola to include in his propaganda piece, except that in video it is so much more intense”

“In this scene, the oncologist tries to point out to Ms. Petagine that he doesn’t know what Burzynski is doing or how to take care of her daughter when she returns”
——————————————————————
I guess the National Heath Service oncologist is possibly like Gorski, and he doesn’t know what Burzynski is doing because he has NOT read Burzynski’s publications:
=====================================
7/22/2013

Critiquing: In which Orac does Stanislaw Burzynski propagandist Eric Merola a favor… :
https://stanislawrajmundburzynski.wordpress.com/2013/07/22/critiquing-in-which-orac-does-stanislaw-burzynski-propagandist-eric-merola-a-favor/
======================================
Gorski flabbergasts:
——————————————————————
“The report includes interviews with experts like Professor Richard Grundy of Nottingham Children’s Hospital”

“Grundy points out that Burzynski has not published the complete results of any of his phase II clinical trials”
——————————————————————
What Gorski does NOT point out, is that for being a supposed “expert”, he sure does NOT give the impression that he’s taken the time to read Burzynski’s 2003-2010 phase II (2) clinical trials preliminary reports, in order to qualify as an “expert” on anything related to Burzynski

Gorski continues on as is his custom of being long-winded without much in the way of results:
——————————————————————
” … how Burzynski has abused the clinical trial process to keep treating patients with antineoplastons without actually having to do the science that any other doctor would be required to do to validate a new treatment”
——————————————————————
However, Gorski FAILS to address these issues:
======================================
WHAT IS MISDIRECTION? Critiquing “Antineoplastons: Has the FDA kept its promise to the American people ?”:
https://stanislawrajmundburzynski.wordpress.com/2013/06/08/what-is-misdirection-critiquing-antineoplastons-has-the-fda-kept-its-promise-to-the-american-people/
======================================
Gorski marches onward, jackbooted:
——————————————————————
“Dr. Elloise Garside, a research scientists, echoes a lot of the questions I have, such as how Burzynski never explains which genes are targeted by antineoplastons, what the preclinical evidence supporting their efficacy are, or what the scientific rationale is to expect that they might have antitumor activity”

“(Yes, we’re talking prior plausibility, baby!)”
——————————————————————
So, Gorski is saying that Dr. Elloise Garside has something in common with the “expert”, Professor Richard Grundy

Gorski rants on:
——————————————————————
“The preponderance of evidence supports the contention that they dont’ work, but there is uncertainty, which Burzynski exploits to the max”
——————————————————————
Amazing !!!

The United States Food and Drug Administration has authorized phase III (3) clinical trials, which means:
======================================
“[T]he emphasis in Phase 2 is on EFFECTIVENESS”

“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2″
======================================
Burzynski: The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-the-fdas-drug-review-process-ensuring-drugs-are-safe-and-effective/
======================================
Gorski then blesses us with:
——————————————————————
” … the claims in some of the Q&A’s after screenings of Eric Merola’s most recent movie that Burzynski’s papers have been rejected without being sent out for peer review”

“Studies submitted to journals won’t be published without going out for peer-review”

“Maybe he’s referring to some of the papers we’ve heard about from Mr. Cohen and others that were editorially rejected and not even sent out for peer review because the editor either didn’t think them appropriate or didn’t want to waste the reviewers’ time”
——————————————————————
Gorski, who did a “review” of Burzynski: Cancer Is Serious Business, Part II (2), 6/3/2013, somehow magically “forgets” the very next day, that the documentary indicates that Burzynski submitted a phase II (2) clinical trial for publication, and was refused in 2 hours 8 minutes and 51 seconds, and Gorski is as silent as the dead about the lame reason given for NOT publishing it
======================================
See #12:
======================================
Critiquing: In which the latest movie about Stanislaw Burzynski “cancer cure” is reviewed…with Insolence:
https://stanislawrajmundburzynski.wordpress.com/2013/07/18/critiquing-in-which-the-latest-movie-about-stanislaw-burzynski-cancer-cure-is-reviewed-with-insolence-2/
======================================
How disingenuous, Gorski

Your opinion should mean

Nada

Zip

Zero

“Orac,” the false god continues on his rampage:
——————————————————————
“In science, all that matters is what you publish, and Burzynski hasn’t published anything other than case reports, tiny case series, and unconvincing studies, mostly (at least over the last decade or so) in crappy journals not even indexed on PubMed”
——————————————————————
Gorski gives NO reason for NOT doing what I have done on my blog, or any relevance of a publication NOT being listed on PubMed:
======================================
The #Burzynski B.S. App:
https://stanislawrajmundburzynski.wordpress.com/2013/06/06/the-burzynski-b-s-app-2/
======================================
Gorski comes to what he must think is his penultimate moment:
——————————————————————
“Without a doubt, the most effective part of the story is the segment in which Dr. Jeanine Graf of the Texas Children’s Hospital is introduced”

“Dr. Graf is the director of the pediatric intensive care unit there and has taken care of lots of Burzynski patients, as her hospital is “just down the road” from the Burzynski Clinic and these unfortunate children are brought to her hospital when they decompensate”

“Particularly damning is how Ms. Petagine said that the Texas Children’s Hospital Staff “were always cleaning up Burzynski’s messes.””

“If there’s one thing Panorama did right in this report, it’s showing how seeing so many already dying children show up in our ICU because of hypernatremia due to antineoplaston therapy will do that”
——————————————————————
Again, Gorski FAILS to discuss:
======================================
Burzynski: HYPERNATREMIA:
https://stanislawrajmundburzynski.wordpress.com/2013/04/24/burzynski-hypernatremia/
======================================
And:
——————————————————————
“Perhaps the most devastating part of this segment was seeing Dr. Graf stating, point blank, that she’s never seen a Burzynski patient survive”
——————————————————————
What is REALLY “devastating” is that Gorski is NOT able to indicate exactly how MANY patients this allegedly applies to, because, whereas Gorski’s fave reporter, Richard Bilton, wants to know how many Burzynski patients were treated in the phase II (2) clinical trials, he acts like Gorski’s “bud”, Dr. Peter A. Lipson, who also has had “issues” with consistency
======================================
Dr. Peter A. Lipson (and / or his Censor(s)) is a Coward: Critiquing “A Film Producer, A Cancer Doctor, And Their Critics”:
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/dr-peter-a-lipson-and-or-his-censors-is-a-coward-critiquing-a-film-producer-a-cancer-doctor-and-their-critics/
======================================
Gorski then rattles off:
——————————————————————
“Burzynski smirks when asked how many patients he’s treated and how many have survived, dodging the question by saying that the FDA won’t let him until he’s published his results”

“Bilton tells him that’s not true; the FDA has told him that Burzynski can tell him as long as he doesn’t promote antineoplastons”

“Burzynski asks Bilton why he doesn’t have a letter from the FDA”
——————————————————————
If Gorski had bothered to read all the comments I posted on his blog re my Burzynski research, he would know that Burzynski has every right to be wary

But Gorski’s arrogance, dismissiveness, and condescension make him his own worst enemy

He then faceplants:
——————————————————————
“Burzynski then promises that antineoplastons will be approved “soon””

“(they almost certainly won’t)”
——————————————————————
I guess Gorski can now see the future, and is all-knowing and omnipotent

But then again, “Orac” is god

“god” goes on to say:
——————————————————————
“Ultimately, the Burzynski Clinic did release some results, stating that 776 patients with brain tumors were treated in trials and that 15.5% have survived five years”

“Of course, this is an utterly meaningless factoid”

“because we don’t know what kinds of tumors, what gradess, how they were treated beforehand, or any other confounding factors”
——————————————————————
But this is because Gorski prefers NOT to pay attention; welcome to “Short Attention Span Theatre”, or seeming to NOT read Burzynski’s publications:
======================================
Colorado Public Television – PBS:
https://stanislawrajmundburzynski.wordpress.com/2013/03/09/colorado-public-television-pbs/
======================================
My Critique of Bob Blaskiewicz (Colorado Public Television – PBS CPT12):
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/my-critique-of-bob-blaskiewicz-colorado-public-television-pbs-cpt12/
======================================
Gorski posted comments on the Colorado Public Television (PBS) (CPT12) Facebook page where this was posted:
======================================

======================================
6/5/2013 Gorski continued his blatherskite:
——————————————————————
Odds and ends left over after the Panorama Burzynski Clinic report: Burzynski versus his own SEC filing
http://scienceblogs.com/insolence/2013/06/05/odds-and-ends-about-burzynski-clinic/
——————————————————————
This is where I start leading to heapin’ helpings of not-so-Respectful Insolence

Gorski posts:
——————————————————————
“(stay classy, Stash, stay classy)”
——————————————————————
I am NOT positive as to why a LIAR would advise Burzynski to “stay classy” when he has absolutely NO moral or ethical standing to do so

The proverbial “pot calling the kettle, black”

Gorski blathers:
——————————————————————
” … in January the Burzynski Clinic removed all references to antineoplaston therapy on its website … “
——————————————————————
As I stated up top, Gorski must have his computer set so that it will NOT access Burzynski’s website, since I posted this:
======================================
3/12/2013

Burzynski updates Scientific Publications page:
https://stanislawrajmundburzynski.wordpress.com/2013/03/12/burzynski-updates-scientific-publications-page/
======================================
This includes the link to Burzynski’s ANTINEOPLASTON publications, which Gorski claims do NOT exist on Burzynski’s website

Perhaps this helps explain Gorski’s lack of knowledge re antineoplastons

Gorski admits:
——————————————————————
“Now I’m not a businessman, and I don’t understand anything but the very basics of business”
——————————————————————
But then goes on to claim:
——————————————————————
“but I do know cancer science”
——————————————————————
Gorski goes on to comment on material which I posted on his blog

Comment #128 Didymus Judas Thomas

At the Tu-Quack Center Correcting Orac’s EPIC & Legendary Research

February 2, 2013
http://scienceblogs.com/insolence/2013/01/21/quoth-joe-mercola-i-love-me-some-burzynski-antineoplastons/
“Yet in the report, we read:”
——————————————————————
On February 23, 2010, the Company entered into an agreement with Cycle Solutions, Inc., dba ResearchPoint (“Research Point”) to initiate and manage a pivotal Phase III clinical trial of combination Antineoplastons A10 and AS2-1 plus radiation therapy (RT) in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma”
——————————————————————
It’s good to see that in JUNE, Gorski is finally catching up to what I posted on his blog in FEBRUARY

Gorski goes on to comment:
——————————————————————
“Of course, given that after three years the clinical trial hasn’t been opened, more than likely no reputable institution wants to partner with the Burzynski Research Institute, and ResearchPoint collected its checks”
——————————————————————
This is the same Gorski who allegedly blogged about the documentary which covered this issue, which he “supposedly” did a“review” on

Gorski, who above claimed that he does NOT understand “business”, suddenly puts on his “lawyer” hat
——————————————————————
“There’s a lot of legalese and FDA bureau-speak, but the meaning should be fairly clear to a layperson”:

“Indeed, even the report seems to concede that antineoplastons will likely never be approved, even going so far to point out that “the Company cannot predict if and/or when it will submit an NDA [New Drug Application] to the FDA, nor can the Company estimate the number or type of additional trials the FDA may require.””

“Burzynski also warns that “there can be no assurance that an NDA for Antineoplastons, as a treatment for cancer, will ever be approved by the FDA.””

“That hardly sounds as though antineoplastons will be approved “soon.””
——————————————————————
I find it remarkable that Gorski, while admitting above that he does NOT understand
“business”, seemingly expects the reader to believe that he understands “legalese”

Gorski bounds on in his new found knowledge as a “legal mastermind”:
——————————————————————
“Another interesting tidbit in the SEC filing is Burzynski’s report of the results of several of his clinical trials”

“They aren’t really “results’ per se, in that the information presented really isn’t provided in a form that really allows other investigators to evaluate it and potentially replicate it”

“Basically it’s a big table listing Burzynski Research Institute clinical trials and response rates reported”

“One thing that I noticed right away is that in most trials, the number of evaluable patients is smaller, sometimes much smaller, than the number of patients accrued”

“This is a huge red flag”

“For instance, in trial BT-20, there were 40 patients accrued by only 22 were evaluable”

“This sort of dropoout rate is a huge red flag”

“We don’t know the reasons for this dropout rate”

“It could certainly skew the results, but even that’s impossible to tell from just a table of response rates and no further information”
� � � � � � � � � � � � � � � �
The ONLY “HUGE RED FLAG” is how inept Gorski is
� � � � � � � � � � � � � � � �
Gorski, you’re no Craig Masilow, but you are a LIAR
� � � � � � � � � � � � � � � �
I’ve done the 1st one for you
======================================
http://www.burzynskiclinic.com/images/stories/Publications/960.pdf

Pg. 96

2 patients unable to be evaluated

patient 2 didn’t have follow-up MRI to determine response

patient 11 died of intratumoral hemorrhage and duration of treatment too short for evaluation of response
======================================
http://www.burzynskiclinic.com/images/stories/Publications/970.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/994.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/1145.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/1146.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/1147.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/1194.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/1220.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/2105.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/5825.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/7287.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/7853.pdf


=====================================
http://www.burzynskiclinic.com/images/stories/Publications/7898.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/8397.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/8637.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/8638.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/8639.pdf


======================================
And THIS is the Gorski who has claimed to have reviewed almost all of Burzynski’s antineoplaston publications
======================================
11/2/2012

“Personally, having pored over Burzynski’s publications … “
http://scienceblogs.com/insolence/2012/11/02/stanislaw-burzynski-fails-to-save-another-patient/
======================================
5/8/2013

“I’ve searched Burzynski’s publications … “
http://scienceblogs.com/insolence/2013/05/08/eric-merola-and-stanislaw-burzynskis-secret-weapon-against-the-skeptics-fabio-lanzoni-part-2/
======================================

Burzynski: The Original 72 Phase II Clinical Trials

11/25/1997 – FORM 10-SB
http://pdf.secdatabase.com/2573/0000950110-97-001598.pdf
� � � � � � � � � � � � � � � � �
1 trial that is retrospective is CAN-1 Clinical Trial
——————————————————————
CAN-1

PATIENTS WITH REFRACTORY MALIGNANCIES
——————————————————————
Clinical trial of patients treated by Dr. Burzynski through 2/23/1996

Analysis has been made of patients with PRIMARY MALIGNANT BRAIN TUMORS (PMBT) in CAN-1 trial:

40 evaluable patients

17 experienced more than 50% reduction in size of tumors, of whom 7 had complete disappearance of tumor

FDA has indicated it will not accept data generated by this trial since it was not a wholly prospective one
=======================================
As of 10/1997, only 2 clinical trials have reached a Milestone
� � � � � � � � � � � � � � � � �
“Clinical Trial BT-11”
——————————————————————
BT-11

PATIENTS WITH BRAIN STEM GLIOMA
——————————————————————
Another trial of Clinical Trial BT-11 involves patients with brain stem glioma

5/1996 trial approved by FDA

After accrual of 12 patients:

1 complete response
3 partial response
� � � � � � � � � � � � � � � � �
“Clinical Trial BT-18”
——————————————————————
BT-18

ADULT PATIENTS WITH MIXED GLIOMA
——————————————————————
Clinical Trial BT-18

intravenous administration of Antineoplastons A10 and AS2-1 in

treatment of “mixed glioma”, a type of PRIMARY MALIGNANT BRAIN TUMORS (PMBT)
——————————————————————
3/1996 was approved by FDA

Results evaluated after 9 patients accrued:

2 complete responses
2 partial responses
� � � � � � � � � � � � � � � � �
ACTIVE PHASE II CLINICAL TRIALS
=======================================
Title of Protocol

Subject of Protocol and Date

Number of Persons Enrolled

Number of Patients who may Participate in the Study
=======================================
AD-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH CARCINOMA OF THE ADRENAL GLAND

2
40
——————————————————————
BL-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH CARCINOMA OF THE BLADDER

3
40
——————————————————————
BR-10 PROTOCOL FOR RANDOMIZED CONTROLLED TRIAL COMPARING METHOTREXATE TREATMENT ALONE TO THE COMBINATION OF METHOTREXATE AND ANTINEOPLASTON A10

7
40
——————————————————————
BR-12 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH CARCINOMA OF THE BREAST

17
40
——————————————————————
BR-14 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 CAPSULES IN

PATIENTS WITH ADVANCED BREAST CANCER

6
40
——————————————————————
BR-6 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN

CHILDREN WITH HIGH GRADE GLIOMA

9
40
——————————————————————
BT-7 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH GLIOBLASTOMA MULTIFORME

34
40
——————————————————————
BT-8 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH ANAPLASTIC ASTROCYTOMA

9
40
——————————————————————
BT-9 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH BRAIN TUMORS

11
40
——————————————————————
BT-10 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

CHILDREN WITH BRAIN TUMORS

5
40
——————————————————————
BT-11 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH BRAIN STEM GLIOMA

15
40
——————————————————————
BT-12 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

CHILDREN WITH PRIMITIVE NEUROECTODERMAL TUMORS; (PNET)

5
40
——————————————————————
BT-13 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

CHILDREN WITH LOW GRADE ASTROCYTOMA

7
40
——————————————————————
BT-14 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

CHILDREN WITH RHABDOID TUMOR OF THE CENTRAL NERVOUS SYSTEM

3
40
——————————————————————
BT-15 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA

17
40
——————————————————————
Pg. 7
=======================================
BT-16 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

ADULT PATIENTS WITH LOW GRADE ASTROCYTOMA

5
40
——————————————————————
BT-17 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

ADULT PATIENTS WITH OLIGODENDROGLIOMA

5
40
——————————————————————
BT-18 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

ADULT PATIENTS WITH MIXED GLIOMA

12
40
——————————————————————
BT-19 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH NEUROFIBROMA AND SCHWANNOMA

0
40
——————————————————————
BT-20 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

ADULT PATIENTS WITH GLIOBLASTOMA MULTIFORME

35
40
——————————————————————
BT-21 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

ADULT PATIENTS WITH PRIMARY MALIGNANT BRAIN TUMORS

19
40
——————————————————————
BT-22 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS

4
40
——————————————————————
BT-23 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN

CHILDREN WITH VISUAL PATHWAY GLIOMA

2
40
——————————————————————
BT-24 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN

PATIENTS WITH EPENDYMOMA

7
40
——————————————————————
BT-25 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN

PATIENTS WITH CRANIOPHARYNGIOMA

0
40
——————————————————————
BT-26 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN

PATIENTS WITH CHOROID PLEXUS NEOPLASM

1
40
——————————————————————
BT-27 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN

PATIENTS WITH GERM CELL TUMOR OF THE BRAIN

0
40
——————————————————————
BT-28 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 INFUSIONS IN

PATIENTS WITH MENINGIOMA

2
40
——————————————————————
CAN-1 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH REFRACTORY MALIGNANCIES

133
133
——————————————————————
CO-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH ADENOCARCINOMA OF THE COLON

12
40
——————————————————————
CO-3 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 CAPSULES IN

PATIENTS WITH ADENOCARCINOMA OF THE COLON

4
40
——————————————————————
ES-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH ADENOCARCINOMA OF THE ESOPHAGUS

4
40
——————————————————————
HB-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

CHILDREN WITH HEPATOBLASTOMA

0
40
——————————————————————
Pg. 8
=======================================
HE-2 PHASE II STUDY OF ANTINEOPLASTONS A10 IN

PATIENTS WITH PRIMARY LIVER CANCER

1
40
——————————————————————
HN-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH CARCINOMA OF THE HEAD AND NECK

6
40
——————————————————————
LA-3 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH ADENOCARCINOMA OF THE LUNG

13
40
—————————————————————–
LA-4 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH LARGE CELL, UNDIFFERENTIATED CARCINOMA OF THE LUNG

4
40
——————————————————————
LA-5 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH BRONCHIAL ALVEOLAR CARCINOMA OF THE LUNG

1
40
—————————————————————–
LA-6 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH SQUAMOUS CELL CARCINOMA OF THE LUNG

5
40
——————————————————————
LA-7 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH SMALL CELL CARCINOMA OF THE LUNG

2
40
——————————————————————
LA-10 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 CAPSULES IN

PATIENTS WITH NON SMALL CELL LUNG CANCER

9
40
——————————————————————
LY-3 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH NON-HODGKIN’S LYMPHOMA

2
40
——————————————————————
LY-6 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH NON-HODGKIN’S LYMPHOMA, LOW GRADE

18
40
——————————————————————
LY-7 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH NON-HODGKIN’S LYMPHOMA, INTERMEDIATE GRADE

10
40
——————————————————————
LY-8 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH NON-HODGKIN’S LYMPHOMA, HIGH GRADE

1
40
——————————————————————
LY-9 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH MANTLE ZONE LYMPHOMA

4
40
——————————————————————
LY-10 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 WITH

CHRONIC MYELOGENOUS LEUKEMIA

0
40
——————————————————————
LY-11 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH MYCOSIS FUNGOIDES – SEZARY SYNDROME

0
40
——————————————————————
LY-12 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA

0
40
——————————————————————
LY-13 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH PRIMARY LYMPHOMA OF THE GASTROINTESTINAL TRACT

0
40
——————————————————————
LY-14 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 INFUSIONS IN

PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

2
40
——————————————————————
Pg. 9
=======================================
MA-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH MESOTHELIOMA

4
40
——————————————————————
ME-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH MALIGNANT MELANOMA

8
40
——————————————————————
MF-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH MALIGNANT FIBROUS HISTIOCYTOMA

0
40
——————————————————————
MM-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH MULTIPLE MYELOMA

5
40
——————————————————————
MW-2 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH MACROGLOBULINEMIA OF WALDESTROM

0
40
——————————————————————
NB-2 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH NEUROBLASTOMA

1
40
——————————————————————
NE-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH NEUROENDOCRINE TUMORS

3
40
——————————————————————
OV-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH CARCINOMA OF THE OVARY

5
40
——————————————————————
PA-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH CARCINOMA OF THE PANCREAS

11
40
——————————————————————
PN-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH PRIMITIVE NEUROECTODERMAL TUMOR OUTSIDE THE CENTRAL NERVOUS SYSTEM

1
40
——————————————————————
PR-4 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE

11
40
——————————————————————
PR-5 PHASE II STUDY OF

ADENOCARCINOMA OF THE PROSTATE

WITH ANTINEOPLASTON A10 AND AS2-1 CAPSULES

16
40
——————————————————————
PR-6 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 CAPSULES IN COMBINATION WITH TOTAL ANDROGEN BLOCKADE IN

PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE

0
40
——————————————————————
PR-8 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE

0
40
——————————————————————
RN-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH CARCINOMA OF THE KIDNEY

9
40
——————————————————————
SA-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH SOFT TISSUE SARCOMA

8
40
——————————————————————
SI-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH CARCINOMA OF THE SMALL INTESTINE

1
40
——————————————————————
ST-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH ADENOCARCINOMA OF THE STOMACH

6
40
——————————————————————
UC-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH CARCINOMA OF THE UTERINE CERVIX AND/OR VULVA

8
40
——————————————————————
10
=======================================
UP-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH CARCINOMA OF AN UNKNOWN PRIMARY

6
40
——————————————————————
WT-2 PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN

PATIENTS WITH WILMS’ TUMOR

2
40
——————————————————————

FDA had authorized Dr. Burzynski to conduct trials of antineoplastons as an investigational drug in clinical studies of some cancers and in special exception cases

(4) the FDA had authorized Dr. Burzynski to conduct trials of antineoplastons as an investigational drug in clinical studies of some cancers and in special exception cases
http://caselaw.lp.findlaw.com/data2/californiastatecases/A087171.DOC
Dr. Burzynski had been authorized since 3/1989 by FDA to treat patients clinically with antineoplastons provided I obtained a special exception

Dr. Burzynski states in a declaration:

“I had been authorized since March 1989 by the FDA to treat patients clinically with antineoplastons provided that they were enrolled in a Phase II clinical trial or I obtained a special exception that allowed me to administer treatment that did not meet one or more of the requirements for acceptance into the trial”

the FDA accepted an investigational new drug application (IND) authorizing him

FDA approval
Investigational New Drug (IND)
AIDS

FDA approval on Investigational New Drug (IND) applications for every drug he uses

Burzynski: Managing social conflict in complementary and alternative medicine research: the case of antineoplastons

3/2004 – antineoplastons – A10 and AS2-1
http://www.ncbi.nlm.nih.gov/m/pubmed/15035877
From 12/1991 – 12/1995 phase II clinical trials were conducted

This publication covers the issues involved

National Cancer Institute (NCI)

National Institutes of Health Office of Alternative Medicine (OAM)

International Peace and Conflict Resolution Program, School of International Service, American University, Washington, DC, USA
Integr Cancer Ther. 2004 Mar;3(1):59-65
Integr Cancer Ther 3(1):59-65 (2004)
Integrative Cancer Therapies
HighWire Press
DOI:10.1177/1534735404263448

Burzynski: The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective

“The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective” advises:
“[T]he emphasis in Phase 2 is on EFFECTIVENESS”
“This phase aims to obtain PRELIMINARY DATA on whether the drug works in people who have a certain disease or condition”
“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2″
“These studies gather more information about safety and EFFECTIVENESS, studying different populations and different dosages and using the drug in combination with other drugs”
http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm