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”

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)
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[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
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[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” ?
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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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Critiquing: Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies

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[3] – Critiquing: Dr. David H. “Orac” Gorski and The Skeptics™
http://www.scienceblogs.com/Insolence
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Critiquing: Dr. David H. “Orac” Gorski and The Skeptics™ http://www.scienceblogs.com/Insolence

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[4] – Critiquing: Dr. David H. “Orac” Gorski, M.D., Ph.D, L.I.A.R.:
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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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Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies

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DID Dr. Michael A. Friedman FIB?:
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DID Dr. Michael A. Friedman FIB ?

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Dr. Michael A. Friedman, DATA ?:
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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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Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet “fact sheet”

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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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Click to access 971.pdf

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[12] – 10/2007
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Click to access 5169.pdf

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[13] – 2008
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Click to access 7854.pdf

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[14] – 2008
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Click to access 7897.pdf

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[15] – 11/2010
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Click to access 8636.pdf

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[16] – 6/2012
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Click to access 9219.pdf

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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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Click to access 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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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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DID Dr. Michael A. Friedman FIB ?

[1] – 6/6/1995 – 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), sent a 3 page letter to Burzynski, in response to his letters of 4/20/1995 and 5/16/1995, which advised, in part, on page 1:

“I will 1st address the questions you raised about individual patients participating in the NCI-sponsored antineoplaston studies“

“2 patients were treated at the National Cancer Institute”

“Patient .26-77-03-9 … at the NCI“

“Patient .27-53-76-5 … “
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6/6/1995 we know “2 patients were treated at the National Cancer Institute” [1]

[2] – 8/23/1995 – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Council, Public Health Division, sent a 1 page letter; which he copied Dr. Michael A. Friedman on, to Burzynski’s attorney, Richard A. Jaffe, Esq., which was in response to his letter of 7/21/1995, and advised, in part:

” … you requested in your letter that we provide you or Dr. Burzynski with the medical records of patients treated by the Principle Investigators”

“The NCI does not possess any individual patient records to provide to Dr. Burzynski”
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6/6/1995 we know per Dr. Michael A. Friedman’s letter that “2 patients were treated at the National Cancer Institute” [1]

8/23/1995 we know that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients per National Institutes of Health (NIH) Legal Advisor Robert B. Lanman [2]

[3] – 9/19/1995 – 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), sent a 2 page letter to Burzynski, which advised, in part:

“I am replying to your 8/29/1995 letter in which you requested “detailed records” of the patients treated in the National Cancer Institute sponsored trials of antineoplastons“

Pg. 2

“We have no individual patient records in our possession in addition to the Theradex reports”
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6/6/1995 we know from Dr. Michael A. Friedman’s letter that “2 patients were treated at the National Cancer Institute”[1]

8/23/1995 we know that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients per National Institutes of Health (NIH) Legal Advisor Robert B. Lanam’s letter [2]

9/19/1995 we know that Dr. Michael A. Friedman advised that “We have no individual patient records in our possession …”[3]

8/23/1995 we know that Dr. Michael A. Friedman was copied on Robert A. Lanman’s letter which stated that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients [2]

All Americans are “presumed to know the law”, so we know that Dr. Michael A. Friedman would have advised Robert B. Lanman if his 8/23/1995 written statement to Burzynski’s attorney, Richard A. Jaffe, Esq., was NOT TRUE [2]

[0] – 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”

[4] – 10/5/1995 – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Counsel, Public Health Division, sent a 1 page letter to Burzynski’s attorney, Richard A. Jaffe, Esq., which advised, in part:

“This is in response to your 9/8/1995 letter in which you reiterate your request for copies of individual patient records and argue that the protocol for the study of Antineoplastons specifically provides that medical records of patients treated by the Principal Investigators will be provided to Dr. Burzynski”

“With regard to the portion of the medical record which you forwarded, the stamp does indicate that the patient was seen at the National Institutes of Health’s Clinical Center“

“We have learned that 2 patients were enrolled … through the Clinical Center and hence … the Clinical Center … has medical records for those 2 individuals”
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6/6/1995 we know from Dr. Michael A. Friedman’s letter that “2 patients were treated at the National Cancer Institute” [1]

8/23/1995 we know that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients per National Institutes of Health (NIH) Legal Advisor Robert B. Lanam’s letter [2]

8/23/1995 we know that Dr. Michael A. Friedman was copied on Robert A. Lanman’s letter which stated that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients [2]

9/19/1995 we know that Dr. Michael A. Friedman advised that “We have no individual patient records in our possession …” in his letter to Burzynski [3]

10/5/1995 we know that Robert B. Lanman admitted that ” … the National Institutes of Health’s Clinical Center … has medical records for those 2 individuals”, in his letter [4]

All Americans are “presumed to know the law”, so we know that Dr. Michael A. Friedman would have advised Robert B. Lanman if his 8/23/1995 written statement to Burzynski’s attorney, Richard A. Jaffe, Esq., was NOT TRUE [2], and / or would have advised Burzynski in his 9/19/1995 letter that the National Cancer Institutes Clinical Center had “medical records for those 2 individuals” [3]

Dr. Michael A. Friedman

6/6/1995 you advised Burzynski that “2 patients were treated at the National Cancer Institute” [1]

8/23/1995 you were copied on Robert A. Lanman’s letter which stated that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients [2]

8/23/1995 we know that you did NOT advise Burzynski that National Institutes of Health (NIH) Legal Advisor Robert B. Lanman’s written statement was NOT TRUE [2]

9/19/1995 you advised Burzynski that “We have no individual patient records in our possession …” [3]

10/5/1995 – Robert B. Lanman admitted that ” … the National Institutes of Health’s Clinical Center … has medical records for those 2 individuals” [4]

Dr. Michael A. Friedman, I know that you would NOT break 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”

Dr. Michael A. Friedman, please let me know why what you did was NOT a LIE

My primary obligation is to the American public, because, I know you would tell the TRUTH, since, in your words, you “could not responsibly act in any other manner”
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[0] – Title 18, Part I, Chapter 47, § 1001

18 USC § 1001 – Statements or entries generally
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http://www.law.cornell.edu/uscode/text/18/1001
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[24] – 1995 (10/27/1995) – Burzynski to Dr. Richard Klausner (7 pgs.)

This page is linked to:
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Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
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Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies

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[24] – 1995 (10/27/1995) – Burzynski 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH)

I was shocked to read the Cancernet “fact sheet” the NCI has been distributing about the cancellation of the clinical trials of antineoplastons, the anti-cancer drugs I discovered and developed

I find it scandalous that a government agency is putting out a public document containing such blatantly false information

Let me remind you that the only reason the clinical trials of antineoplastons were stopped is that NCI would not conduct them as per our written agreement

NCI’s “fact sheet” tries to obscure that simple fact with misinformation such as the following:

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

For this review, Dr. Burzynski selected from his entire clinical experience 7 brain tumor patients whom he felt had a beneficial effect from antineoplastons.”

This misstatement is obviously calculated to make the reader think that in my entire clinical experience I have had only 7 patients who benefitted from antineoplaston treatment, which is wildly untrue

In fact, I prepared not 7, but dozens of cases for the NCI reviewers

As you must know, the reviewers were able to spend just one day at the clinic–enough time to review only 7 cases

Cancernet then compounds that misstatement with the following:

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

To the contrary, the patient medical records that NCI scientists reviewed were exhaustive and did contain “all available patient information.”

In fact, Michael Hawkins, M.D., leader of the site visit team, specifically complimented me on how complete and well-organized they were

The next misstatement is the following:

“The reviewers of this series determined that there was presumptive evidence of antitumor activity . . .”

Pg. 2

Now that the NCI’s Cancer Therapy Evaluation Program (CTEP) is under fire for misconduct in these clinical trials, it is rewriting history

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

Their report (minutes of Decision Network committee meeting enclosed) stated that “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” (my italics)

In other words, according to the site visit team, there was no question that the treatment worked in the cases reviewed

All that remained to be determined were the numerator and the denominator

Even the NCI’s own previous “fact sheet” on antineoplastons, dated 2/17/1994, (enclosed), 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” (my italics)

But by far the most outrageous misstatement is the following:

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

The NCI never made any effort to “reach a consensus.”

Instead, it simply violated the written protocol we had agreed upon

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

in other words, NCI was accepting patients whose brains and spinal cords were literally consumed by large malignant tumors–patients so advanced as to have no chance whatsoever

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

The above is all well documented

While we were still in the negotiating stages, Michael Friedman, M.D. of the NCI wrote me a letter dated 11/2/1993 (enclosed) “. . . we will accede to all the modifications that you have stipulated.”

Dr. Friedman specifically agreed to exclude patients with:

* tumors larger than 5 cm (2 inches)
* multiple tumors
* metastases to spinal cord
* Karnofsky performance scores less than 70%

Based on Dr. Friedman’s written assurance that NCI would honor this exclusion criteria, I provided NCI with a large quantity of antineoplastons, and the clinical trial began

on 3/23/1994, Mario Sznol, M.D., of NCI wrote me proposing that NCI drop the exclusion for multiple tumors and spinal cord metastases, increase the maximum tumor size from 5 cm to 8 cm, and lower the Karnofsky score from 70 to 60 (enclosed)

in a response dated 4/19/1994 (enclosed), I wrote back that I would be glad to help NCI design a separate trial for such advanced patients, using a more aggressive dosage schedule

But I made it clear that it would be unethical to use the current dosage schedule on such patients since my experience had shown that such patients do not respond well to it

Pg. 3

As proof , I pointed out that in the NCI’s own review of patients treated with antineoplastons, the only ones who had less than 50% tumor shrinkage were exactly those with tumors greater than 5 cm

I did not hear back from NCI and assumed the matter had been dropped

Nearly one year later–in 3/1995–I learned that NCI had made all the changes to which I had objected

In fact, NCI went even further

Rather than raising the maximum tumor size from 5 to 8 cm as the NCI earlier suggested, it began accepting patients with any size tumor

I insisted that NCI either honor our agreement or change the Informed Consent statement (which patients must read and sign) to reflect the fact that I, the drug’s discoverer and developer, felt that the treatment was unlikely to be effective in such advanced patients in the doses being used

Rather than honor it’s commitment to conduct the study as agreed, NCI cancelled it

I find it particularly curious that now neither NCI nor Memorial Sloan-Kettering Cancer Center (MSK) will take responsibility for changing the exclusion criteria, and are instead pointing fingers at each other

in his letter of 4/3/1995 (enclosed), Dr. Sznol repeatedly refers to the “revised” eligibility criteria proposed by the [Memorial Sloan-Kettering] investigators” (my italics)

But, in a letter to John Lewis, M.D., of Memorial Sloan-Kettering’s Institutional Review Board dated 1/31/1995 (enclosed), the Chief Investigator, MSK’s Mark Malkin, M.D., writes that

“Further amendments, as described below, have been made at the request of NCI” (my italics)

If the changes to the protocol are as the NCI would have the world believe, why is everyone connected to them scurrying to disavow responsibility?

An even more serious matter is what appears to be the investigator’s relentless violations of the treatment protocol

Looking at the treatment summaries compiled by Theradex Corporation, the medical reporting company hired by NCI to compile and tabulate patient treatment data, it would appear that investigators violated the agreed-upon protocol in every patient treated

Apparent violations include the removal of patients from treatment who had no tumor growth (including one patient who, during subsequent surgery, was found to have no cancer cells remaining), and the removal of a patient for “skin reactions” caused not by antineoplastons, but by another drug patient was receiving, DPH

This is clear due to the fact that the patient’s skin condition worsened when he was taken off antineoplastons

It improved only after DPH was discontinued

The summaries provided by Theradex are somewhat sketchy, so I asked to review the complete records of patients tested–which Dr. Friedman had specifically promised to provide

NIH lawyer Robert Lanman replied in a letter dated 8/23/1995 (enclosed) that the NCI did not have any such records

In fact, several patients were treated at NCI and of course NCI has their complete medical records

When I demonstrated this by sending Mr. Lanman copies of patient records obtained by a patient’s family from NCI, he admitted in fact NCI does have patient records, but refused to release them

And he disregarded his own misstatements of fact by saying that

“Given that you apparently have already obtained at least one of the patient’s records, we fail to understand why you are perusing this matter” (letter from Robert Lanman dated 10/5/1995 enclosed)

Mr. Lanman also claims that NCI has “no such commitment” to release medical records of patients treated with antineoplastons

And Dr. Friedman, in a letter dated 9/19/1995 (enclosed), writes that Dr. Burzynski’s request for “detailed records” has been satisfied by the sketchy Theradex treatment summaries

Pg. 4

Both these statements directly contradict Dr. Friedman’s letter of 11/2/1993 (enclosed), in which he promises that

“In accordance with your letter, we will arrange a review of data after accrual of the 1st 5-6 patients, which should occur 6 months after the study has been initiated

This should be sufficient to assure that the conduct of the study is satisfactory

The Theradex database is also available . . .” (my italics)

In other words, Dr. Friedman promised to provide me with patient medical records, recognizing that the Theradex summaries are something quite separate

In that same 9/19/1995 letter, Dr. Friedman writes that

“We have no individual patient records in our possession in addition to the Theradex reports.”

Either he is deliberately misstating the facts, or he is out of touch with the Cancer Therapy Evaluation Program that he runs

Dr. Klausner, I request that you immediately withdraw the “fact sheet” the NCI is distributing which contains numerous and outrageous misstatements and distortion of fact

Thank you for your attention to this matter

SRB/cf

cc:

3+ pgs cc:
——————————————————————

======================================
1993 (11/2/1993) – Dr. Michael Friedman to Burzynski
1994 (2/17/1994) – NCI “fact sheet”
1994 (3/23/1994) – Dr. Mario Sznol to Burzynski
1994 (4/19/1994) – Burzynski to Dr. Mario Sznol
1995 (1/31/1995) – Dr. John L. Lewis
1995 (4/3/1995) – Dr. Mario Sznol to Burzynski
1995 (8/18/1995) –
1995 (8/23/1995) – Robert B. Lanman to Burzynski
1995 (9/19/1995) – Dr. Michael A. Friedman to Burzynski
1995 (10/5/1995) – Robert B. Lanman to Burzynski
======================================

[22] – 1995 (9/19/1995) – Dr. Michael A. Friedman to Burzynski (2 pgs.)

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————

Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies

======================================
[22] – 1995 (9/19/1995) – Dr. Michael A. Friedman, Michael A. Friedman, M.D., 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) 2 page letter to Burzynski

I am replying to your 8/29/1995, letter in which you requested “detailed records” of the patients treated in the National Cancer Institute sponsored trials of antineoplastons

Our records indicate that the data has been regularly supplied to you by our contractor, Theradex, as listed below:

Date Report

7/18/1994 Clinical Studies Summary
8/24/1994 Clinical Studies Summary
9/19/1994 Clinical Studies Summary
10/24/1994 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report
11/14/1994 Clinical Studies Summary
12/19/1994 Clinical Studies Summary
1/13/1995 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report
2/21/1995 Clinical Studies Summary
3/15/1995 Clinical Studies Summary
4/10/1995 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report

Pg. 2

I am enclosing a summary of the categories of data that are included in the reports you have received

These reports are the same ones that have been provided to us by the contractor during the conduct of the Antineoplaston studies

Both the format and frequency of these reports are routine for reporting data of ongoing NCI Phase II trials to the Cancer Therapy Evaluation Program staff

These are also the same types of reports that are provided to pharmaceutical companies when they are cosponsors of a study

We have no individual patient records in our possession in addition to the Theradex reports

As of the last report provided to you of 4/10/1995, prior to the studies being put on hold and subsequently closed, you were sent the same reports that were provided to CTEP staff and protocols T93-0078 and T93-0134

However, enclosed for your convenience is a recent print-out of the data that was prepared for our staff in a slightly different format

Once the routine quality control review of data entry has been completed, we will send you a final print-out
======================================
1995 (9/19/1995) – Friedman to Burzynski [18]
======================================

[18] – 1995 (5/16/1995) – Burzynski to Dr. Michael A. Friedman

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————

Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies

======================================
[18] – 1995 (5/16/1995) – Burzynski letter to Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), National Institutes of Health (NIH)

Thank you for your letter of 5/12/1995

You are correct in asserting that I raise issues of ethical misconduct, failure to obtain adequate informed consent and scientific misjudgment

To be exact, my letter points out specific violations of the clinical trial protocol made by the current investigators

I provided careful documentation of some of the most egregious violations, including the removal of a patient from the study who had no increase in tumor size and the inclusion of a patient with tumor pathology that did not meet the entry criteria

It seems possible that, in at least one one of these cases, failure to follow the protocol resulted in the patient’s unnecessary death

In this case, the patient was removed from the study following an MRI dated 5/2/1994

The conclusion of neuroradiologist Jim Cain, MD, is that this MRI shows that the tumor had not grown, and no new tumors are present

As you know, the protocol calls for patients to be taken off treatment if the tumor grows 50% or more, or a new tumor is present

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

Contrary to another of your statements, I did provide “specific clinical data which support” my contention that patients with large tumors do not respond well to the current protocol

Let me repeat from here

In the 1991 NCI review of 7 brain tumor cases, the only 2 patients with tumor size greater than 5.1 cm were also the only 2 patients to have less than 50% reduction of their tumor

The correlation between large tumor size and failure to respond is obvious

I am happy to learn that the trials have been put on hold

I must insist that they not be re-activated until I am satisfied that new investigators have been found who are capable of following the protocol — the original protocol on which we both agreed

As you know, the protocol was changed without anyone bothering to seek my advice, and certainly without my consent

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

However, this review must not be done by the people responsible for the violations being investigated

This would amount to a whitewash of the whole affair, and is unacceptable

The review must be done by an independent body of experts acceptable to both of us

Otherwise it will be meaningless

I still have not received the complete data on the 1st 5 patients, which was promised in your letter of 4/3/1995

I hope to receive the data soon

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

cc:

Senator Joseph Biden
Senator Barbara Boxer
Senator Diane Feinstein
Senator Tom Harkin
Senator Barbara Mikulski
Congressman Berkley Bedell
Congresswoman Nancy Pelosi
Dr. Jan Buckner
Dr. Jay Greenblatt
Mr. Richard Jaffe
Dr. Wayne Jonas
Mr. Robert Lanman
Ms. Mary McCabe
Dr. Mark Malkin
Dr. Tony Murgo
Dr. Ralph Moss
Dr. David Parkinson
Dr. Edward Sondik
Dr. Mario Sznol
Dr. Dorothy Tisevich
Dr. Alan Trachtenberg
Mr. Frank Wiewel
Dr. Robert Wittes
——————————————————————

======================================
1995 (5/16/1995) – Burzynski to [15]
(2 pgs.)
1991 NCI review of 7 brain tumor cases
1994 – 5/2/1994 – MRI
1995 (4/3/1995) – Dr. Michael A. Friedman to Burzynski
1995 (4/20/1995) – Burzynski to
1995 (5/12/1995) – Dr. Michael A. Friedman to Burzynski
======================================

Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies

One of Dr. David H. “Orac” Gorski’s “Oracolytes,” a wooshipper of their Lord and Master, Lord Frackonis AstroidZeneca posted this “gem” of a comment on National Geographic’s (#NatGeo) scienceblogs . com/Insolence
——————————————————————
[A] – 4/30/2013 – #98 – Krebiozen – May.28, 2013

BTW, DJT appears to have completely unraveled on his blog, calling Orac, “a self-proclaimed “cancer researcher” ” making many other blatantly libelous statements, ranting on, and on, and on. He is clearly unwell. If anyone who knows him personally happens to read this, please get him some professional help.
——————————————————————
What does Krebiozen think Dr. David H. “Orac” Gorski is going to do since I’ve been giving the “big reveal” to some of his lies, misdirection, misinformation, and disinformation ?

Sue me for telling the truth about his lies ?
——————————————————————
[B] – 12/.5/2012 – Gorski posted:

“Indeed, one could argue that that’s why the FDA and the NCI couldn’t work with him” (Burzynski)

“They didn’t know him when they agreed to work with him in the 1990s, but as they worked with him over the course of a few years they learned his true nature, leading to an inevitable schism, which taught the NCI a lesson about the consequences of dealing with pseudoscientists”
——————————————————————
Does Gorski provide a “citation” for his claim ?

no !

Does he provide a “reference” ?

No !!

A “link” ?

NO !!!

So where did Gorski come up with this unsubstantiated claim ?

Well, it seems that Gorski has cited The Cancer Letter before without attribution
——————————————————————
[C] – 9/25/1998 – “Stanislaw Burzynski, a Polish-trained physician who initially produced antineoplastons by extracting them from human urine”
——————————————————————
[D] – 2/19/2013 – Now where have I seen a questionable statement like this before ?
——————————————————————
[E] – 1/14/2013 – Gorski posted: “As you might recall, antineoplastons are chemicals that Burzynski found in the urine of cancer patients … “
——————————————————————
[C] – 9/25/1998 – The Cancer Letter indicated that a:

“trial of antineoplastons, coordinated by NCI, began at Memorial Sloan-Kettering Cancer Center, the Mayo Clinic, and the NIH Clinical Center“
——————————————————————
And that the
——————————————————————
“trial, which tested Burzynski’s drug in advanced recurrent malignant glioma, accrued 9 patients and was aborted as a result of a dispute“

“The dispute generated a stack of mutually recriminating memos, in which Burzynski accused the investigators of attempting to scuttle the trial, while NCI officials responded with requests that Burzynski provide the data that would back his accusations
——————————————————————
[F] – 6/23/2013 – Gorski has already proved that he does NOT have what it takes to provide the answers for the National Cancer Institute (NCI) at the National Institutes of Health (NIH)
——————————————————————
[G] – 3/30/2013

Odd how @BurzynskiMovie pretends I haven't deconstructed his "evidence" in depth before. http://t.co/uiGeNelAlb @bbcpanorama @vguyuk @fxnwo

— David Gorski, MD, PhD (@gorskon) March 30, 2013

NO, Dr. Gorski, you have NOT “deconstructed his” evidence “in depth before”

Burzynski: Cancer Is Serious Business (Part I) consists of the documentary; which covered some of this, as well as the documents on the movie web-site, which you have NOT “deconstructed … in depth before”, since you
“cherry-picked” what you reviewed

Allow me
=======================================
[1] – 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 (RAB), Cancer Therapy Evaluation Program (CTEP), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH), National Cancer Institute (NCI), and 2 invited consultants; including one from the National Institutes of Health (NIH) Clinical Center) visited the offices of Dr. Stanislaw R. Burzynski
=======================================
[2] – 10/30/1991 – Dorothy K. Macfarlane, M.D., Head, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH), National Cancer Institute (NCI) sent a 1 page letter and 5 page Memorandum to Burzynski
=======================================
[3] – 10/30/1991 – Dorothy K. Macfarlane, M.D., Head, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Department of Health & Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), sent the 5 page Memorandum re: Review of Brain Tumor Cases Treated With Antineoplastons to 6 doctors
=======================================
======================================
[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 (NIH), National Cancer Institute (NCI), 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”

=======================================
[5] – 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 7 page letter re: Antineoplaston 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 … “

=======================================
[6] – 12/2/1991 – 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 … “

=======================================
[00] – 1991 (12/1991) – the National Cancer Institute (NCI) initiated phase II clinical trials of A10 and AS2-1 (antineoplastons)
=======================================
[7] – 10/20/1993 – Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institutes (NCI), Department of Health and Human Services (HHS), National Institutes of Health (NIH) sent a 4 page letter to Burzynski, which had on page 4:
=======================================
======================================
“If you are unable or unwilling to provide the antineoplastons in the near future, we will pursue alternative sources to procure the drug or its active components, and will proceed with a clinical development plan to determine whether these chemicals have activity and are beneficial for patients“

=======================================
[8] – 10/26/1993 – Burzynski sent a 5 page letter to Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institutes (NCI), National Institutes of Health (NIH), which had on page 5
=======================================
======================================
“Your final statements that you are ready to proceed with the treatment with Antineoplastons without our participation caught me by surprise”

“It is hard to imagine that a Federal employee would consider patent infringement, thus infringing on the patent rights of thousands of our shareholders”

——————————————————————
Dr. Michael A. Friedman, please take time away from being a “member of the Nominating Committee” and “director” at Forbes (#Forbes)
——————————————————————
http://www.forbes.com/profile/michael-friedman/
——————————————————————
to let us know how you planned to:

“pursue alternative sources to procure the drug (Antineoplaston) or its active components”

when Burzynski has a patent on some of “its active components” ?

I’m sure your position has nothing to do with the “hack piece” Forbes did on Burzynski where they censored my comments [000]
=======================================
[9] – 11/2/1993 – Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services, Public Health Services, National Institutes of Health (NIH), sent a 3 page letter to Burzynski, which had on page 3
=======================================
======================================
“Finally, if even after modifying these studies in accordance with your stated wishes, you are unwilling to supply the antineoplaston materials, please inform me as quickly as possible”

“We will then seek alternative sources of this family of molecules for proper clinical evaluation”

Dr. Michael A. Friedman, please take time away from planning your retirement from “City of Hope”
——————————————————————
http://m.prnewswire.com/news-releases/city-of-hope-names-robert-stone-as-new-chief-executive-officer-192239551.html
——————————————————————
to let us know how you planned to:

” … then seek alternative sources of this (Antineoplaston) family of molecules for proper clinical evaluation”, when Burzynski has a patent on some of “this family of molecules”?
=======================================
[10] – 1/18/1994 – Proposal for Clinical Investigation [2 pgs.]

Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Advanced Recurrent Malignant Astrocytomas

N.C.I. Protocol # T93-0078

Pg. 2

1.0 Protocol Summary – Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Advanced Recurrent Malignant Astrocytomas

1.1 Patient Eligibility

k) Patients with tumors > 5 cm in diameter, multifocal tumors, or with leptomeningeal or with systemic metastases are excluded

1.2 Pretreatment Evaluation

1.3 Treatment Plan

=======================================
[11] – 3/23/1994 – Mario Sznol, M.D., Head, Biologics Evaluation Section, Investigational Drug Branch, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Services, National Institutes of Health (NIH), National Cancer Institutes (NCI) sent a 2 page letter to Burzynski requesting to:

1. Lower the Karnofsky performance status (KPS) from 70 to 60

2. Raise the tumor size restriction from 5 cm or less to 8 cm or less

3. Drop the exclusion of multifocal tumors and leptomeningeal spread

=======================================
[12] – 4/19/1994 – Burzynski sent a 2 page letter to Mario Sznol, M.D., Head, Biologics Evaluation Section, Investigational Drug Branch, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Services, National Institutes of Health (NIH), National Cancer Institutes (NCI), the it was his opinion that cancer patients with larger tumors should:

1. NOT be included in the protocol intended for patients with smaller tumors receiving less antineoplastons

2. Cancer patients with larger tumors should be accepted in a separate protocol for larger tumors using larger doses of antineoplastons if the existing protocol showed promise

=======================================
[13] – 1/31/1995 – Mark G. Malkin, M.D. sent a one page letter to John L. Lewis, M.D., Chairman, Institutional Review Board (IRB), Memorial Sloan-Kettering Cancer Center (MSKCC) re: T93-0078, RE: Protocol # 93-105, indicating that the National Cancer Institute (NCI) had changed the protocol by:

1. Lowering the Karnofsky Performance Status Score (KPS) from 70% to 60%

2. Removing the exclusion criteria so that there was “no exclusion based on tumor size, multifocality, or leptomeningeal or systemic metastases”

Dr. Mark G. Malkin, the Institutional Principal Investigator, Department of Neurology, Memorial Sloan-Kettering Cancer Center (MSKCC) who sent this letter to Dr. John L. Lewis, the Protocol Chairman, can you take time from your position at the Medical College of Wisconsin
——————————————————————
http://www.mcw.edu/neurology/faculty/MarkMalkin.htm
——————————————————————
and explain why Burzynski was NOT copied on this letter since you knew from his 4/19/1994 response [12] to your 3/23/1994 letter [11] that he did NOT agree to changing the protocol?
=======================================
[14] – 3/29/1995 – Burzynski sent a 2 page letter to Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), National Institutes of Health (NIH), advising him that he had learned that the protocol had been changed without his knowledge or concurrence by:

1. Lowering the Karnofsky Performance Status score (KPS) from 70% to 60%

2. Changing the eligibility criteria from tumors 5 cm or less to patients with tumors measuring over 5 cm in diameter, multiple tumors, or with leptomeningeal spread or systemic metastases

Dr. Michael A. Friedman, please take time from your Non-Executive Director appointment at Smith & Nephew plc (LSE: SN, NYSE: SNN), the global medical technology business
——————————————————————
http://www.smith-nephew.com/news-and-media/news/michael-a-friedman-md-appointed-non-executive-director/
——————————————————————
and advise why these changes where made to the protocol, when your 3 page letter of 11/2/1993 [9] to Burzynski, advised:

Pg. 1

“[W]e will accede to all the modifications that you have stipulated”

“The changes to made to the protocol are as follows:”

1. “The dose and schedule will be modified exactly as your require”

Pg. 2

5. “The eligibility criteria will be modified to accept only patients with a Karnofsky performance status of 70-100%“

=======================================
[15] – 4/3/1995 – Mario Sznol, M.D., Department of Health and Human Services (HHS), Public Health Services, National Institutes of Health (NIH), National Cancer Institutes (NCI) sent a 2 page letter to Burzynski for Dr. Michael A. Friedman in response to Burzynski’s 3/29/1995 letter [14] advising:

“At the investigator’s request, the amendments to modify the eligibility restrictions for size of tumor, number of tumors, and leptomeningeal spread, and to allow entry of patients with KPS of 60, have been approved“

as if the National Cancer Institute (NCI) had NOT already changed the protocol 1/31/1995 [13]

=======================================
[16] – 4/20/1995 – Burzynski sent a 3 page letter to Mario Sznol, M.D., Department of Health and Human Services (HHS), National Institutes of Health (NIH)

=======================================
[17] – 4/26/1995 –

=======================================
[18] – 5/16/1995 – Burzynski sent a 3 page letter to Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), National Institutes of Health (NIH)

=======================================
[19] – 6/6/1995 – Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH), sent a 3 page letter to Burzynski

=======================================
[0000] – 7/27/1995 pg. A17 The Washington Post

In Absentia, Regulators Put on Trial by Critics

‘But researchers who have tried to duplicate Burzynski’s success have been frustrated, said Michael A. Friedman, associate director of the National Cancer Institute’s cancer therapy evaluation program in no small part because Burzynski has refused to cooperate fully”

Dr. Michael A. Friedman
——————————————————————
https://tulane.edu/presidentialsearch/michael-friedman.cfm
——————————————————————
I’m sure that Dr. David H. Gorski a/k/a “Orac” would have something to say about you commenting on a clinical trial before the final results were published, but what do you mean by:

“Burzynski has refused to cooperate fully” ?
=======================================
[20] – 8/18/1995 – CancerNet from the National Cancer Institute (NCI) [2 Pgs.]
Date Last Modified 10/1995

=======================================
[21] – 8/23/1995 – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor sent a one page letter to Richard A. Jaffe, which advised, in part:

“The NCI does not possess any individual patient records to provide to Dr. Burzynski”

=======================================
[22] – 9/19/1995 – Dr. Michael A. Friedman sent a 2 page letter to Burzynski, which advised, in part, on page 2:

“We have no individual patient records in our possession in addition to the Theradex reports”

=======================================
[23] – 10/5/1995 – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor sent a one page letter to Richard A. Jaffe, which advised, in part:

“With regard to the portion of the medical record which you forwarded, the stamp does indicate that the patient was seen at the National Institutes of Health’s Clinical Center”

“We have learned that 2 patients were enrolled in the Sloan-Kettering study through the Clinical Center and hence, even though the Clinical Center did not have its own protocol, it has medical records for those 2 individuals”

=======================================
[24] – 10/27/1995 – Burzynski sent a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH)

=======================================
[00] – 1995 (12/1995) – the National Cancer Institute (NCI) initiated phase II clinical trials of A10 and AS2-1 (antineoplastons) from 12/1991 – 12/1995
=======================================
[25] – 1/15/1998 – Robert J. Waldbillig, Ph.D.

Pharmacokinetics of Antineoplaston A10 and AS2-1 in Patients with Neoplastic Disease (2 pgs.)

Pg. 2

Translated into ug/mL from page 22 of 1998 FDA report on ANP

Plasma Antineoplaston Levels in Patients During Treatment

Name of Antineoplaston Ingredient
PG
IsoPG
PN

Plasma Levels (ug/mL)

Mayo Clinic (MC)
302
14 to 35
177

Burzynski
11088
2376
476

Ratio
Burzynski / MC
36 x higher
67-169 x higher
2.7 x higher
=======================================
[26] – 2/1999 Volume 74 Number 2 [3 Pgs. – Pg. 137]

Phase II Study of Antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in Patients With Recurrent Glioma

Jan C. Buckner, M.D. (Mayo) Dept.Oncology
Mark G. Malkin, M.D.
Eddie Reed, M.D.
Terrence L. Cascino, M.D.
Joel M. Reid, Ph.D.
Matthew M. Ames, Ph.D.
William P.Y. Tong, Ph.D.
Silam Lam, Ph.D.
William D. Figg, Pharm.D.

Patients with
anaplastic astrocytoma
and
glioblastoma multiforme

=======================================
National Cancer Center (NCI) at the National Institutes of Health (NIH), I do believe this is some of “the data that would back his” (Burzynski’s) “accusations”

Dr. David H. Gorski a/k/a “Orac”, enjoy !
======================================
REFERENCES [A – G]:
======================================
[A] – 4/30/2013 – Eric Merola and Stanislaw Burzynski’s secret weapon against The Skeptics™: Fabio Lanzoni (I kid you not)
——————————————————————
http://scienceblogs.com/insolence/2013/04/30/eric-merola-stanislaw-burzynskis-secret-weapon-against-the-skeptics-fabio-lanzoni/
======================================
[B] – 12/5/2012 – Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————
http://scienceblogs.com/insolence/2012/12/05/arrogance-of-ignorance-about-cancer/
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[C] – 9/25/1998 – The Antineoplaston Anomaly: How a Drug Was Used for Decades in Thousands of Patients, With No Safety, Efficacy Data
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http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/burzynski2.html
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The Cancer Letter, Vol. 24, No. 36, Sept.25, 1998
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[D] – 2/19/2013
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http://m.cancer.gov/topics/CAM/antineoplastons/Patient?print=1
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http://m.cancer.org/treatment/treatmentsandsideeffects/complementaryandalternativemedicine/pharmacologicalandbiologicaltreatment/antineoplaston-therapy
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[E] – 1/14/2013 – The story of Seán Ó’Laighin, patient of Dr. Stanislaw Burzynski
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http://scienceblogs.com/insolence/2013/01/14/the-story-of-sean-olaighin-patient-of-dr-stanislaw-burzynski/
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[F] – 6/23/2013 – QUESTIONS the Critics and Cynics, “The Skeptics™” do NOT want to ANSWER:
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QUESTIONS the Critics and Cynics, “The Skeptics™” do NOT want to ANSWER

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[G] – 3/20/2013 – David Gorski (@gorskon) tweeted at 12:44pm – 30 Mar 13:
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REFERENCES:
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1] – 1991 (10/4/1991) – Site visit – Antineoplaston Cases:
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[1] – 1991 (10/4/1991) – Site visit – Antineoplaston Cases

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[2] – 1991 (10/30/1991) – Dr. Dorothy K. Macfarlane letter to Burzynski:
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[2] – 1991 (10/30/1991) – Dr. Dorothy K. Macfarlane letter to Burzynski

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[3] – 1991 (10/30/1991) – Dr. Dorothy K. Macfarlane Memorandum – 10/4/1991 – site visit (5 pgs.):
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[3] – 1991 (10/30/1991) – Dr. Dorothy K. Macfarlane Memorandum – 10/4/1991 – site visit (5 pgs.)

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[4] – 1991 (10/31/1991) – Dr. Michael A. Friedman Memorandum to Dr. Bruce A. Chabner (1 pg.):
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[4] – 1991 (10/31/1991) – Dr. Michael A. Friedman Memorandum to Dr. Bruce A. Chabner (1 pg.)

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[5] – 1991 (11/15/1991) – Dr. Michael J. Hawkins to Decision Network:
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[5] – 1991 (11/15/1991) – Dr. Michael J. Hawkins to Decision Network

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[6] – 1991 (12/2/1991) – NCI Decision Network Report on Antineoplastons:
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[6] – 1991 (12/2/1991) – NCI Decision Network Report on Antineoplastons

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[00] – 1991 (12/1991) – Burzynski: Managing social conflict in complementary and alternative medicine research: the case of antineoplastons:
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Burzynski: Managing social conflict in complementary and alternative medicine research: the case of antineoplastons

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[7] – 1993 (10/20/1993) – Dr. Michael A. Friedman to Burzynski (4 pgs.):
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[7] – 1993 (10/20/1993) – Dr. Michael A. Friedman to Burzynski (4 pgs.)

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[8] – 1993 (10/26/1993) – Burzynski to Dr. Michael A. Friedman:
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[8] – 1993 (10/26/1993) – Burzynski to Dr. Michael A. Friedman

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[000] – Dr. Peter A. Lipson (and / or his Censor(s)) is a Coward: Critiquing “A Film Producer, A Cancer Doctor, And Their Critics”:
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Dr. Peter A. Lipson (and / or his Censor(s)) is a Coward: Critiquing “A Film Producer, A Cancer Doctor, And Their Critics”

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[9] – 1993 (11/2/1993) – Dr. Michael A. Friedman to Burzynski:
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[9] – 1993 (11/2/1993) – Dr. Michael A. Friedman to Burzynski

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[10] – 1994 (1/18/1994) – Proposal for Clinical Investigation (2 pgs.):
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[10] – 1994 (1/18/1994) – Proposal for Clinical Investigation (2 pgs.)

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[11] – 1994 (3/23/1994) – Dr. Mario Sznol to Burzynski [2 pgs.]:
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[11] – 1994 (3/23/1994) – Dr. Mario Sznol to Burzynski [2 pgs.]

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[12] – 1994 (4/19/1994) – Burzynski to Dr. Mario Sznol [2 Pgs.]:
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[12] – 1994 (4/19/1994) – Burzynski to Dr. Mario Sznol [2 Pgs.]

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[13] – 1995 (1/31/1995) – Dr. Mark G. Malkin to Dr. John L. Lewis (1 pg.):
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[13] – 1995 (1/31/1995) – Dr. Mark G. Malkin to Dr. John L. Lewis (1 pg.)

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[14] – 1995 (3/29/1995) – Burzynski to Dr. Michael A. Friedman (2 pgs.):
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[14] – 1995 (3/29/1995) – Burzynski to Dr. Michael A. Friedman (2 pgs.)

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[15] – 1995 (4/3/1995) – Dr. Mario Sznol to Burzynski:
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[15] – 1995 (4/3/1995) – Dr. Mario Sznol to Burzynski

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[16] – 1995 (4/20/1995) – Burzynski to Dr. Mario Sznol;
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[16] – 1995 (4/20/1995) – Burzynski to Dr. Mario Sznol

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[17] – 1995 (4/26/1995) (Pg. 3):
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[17] – 1995 (4/26/1995) (Pg. 3)

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[18] – 1995 (5/16/1995) – Burzynski to Dr. Michael A. Friedman:
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[18] – 1995 (5/16/1995) – Burzynski to Dr. Michael A. Friedman

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[19] – 1995 (6/6/1995) Dr. Michael A. Friedman to Burzynski (3 pgs.):
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[19] – 1995 (6/6/1995) Dr. Michael A. Friedman to Burzynski (3 pgs.)

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[0000] – 7/27/1995 – 1 pg.
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Click to access Scqd59b00.pdf

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2 pgs.
——————————————————————

Click to access Syiw77d00.pdf

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[20] – 1995 (8/18/1995) – CancerNet from the National Cancer Institute (2 pgs.): CANCER FACTS
National Cancer Institute • National Institutes of Health Department of Health and Human Services, Antineoplastons, pg. 1
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[20] – 1995 (8/18/1995) – CancerNet from the National Cancer Institute (2 pgs.)

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

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[21] – 1995 (8/23/1995) – Robert B. Lanman to Burzynski (1 Pg.):
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[21] – 1995 (8/23/1995) – Robert B. Lanman to Burzynski (1 Pg.)

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[22] – 1995 (9/19/1995) – Dr. Michael A. Friedman to Burzynski (2 pgs.):]
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[22] – 1995 (9/19/1995) – Dr. Michael A. Friedman to Burzynski (2 pgs.)

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[23] – 1995 (10/5/1995) – Robert B. Lanman to Burzynski (1 pg.):
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[23] – 1995 (10/5/1995) – Robert B. Lanman to Burzynski (1 pg.)

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[24] – 1995 (10/27/1995) – Burzynski to Dr. Richard Klausner (7 pgs.):
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[24] – 1995 (10/27/1995) – Burzynski to Dr. Richard Klausner (7 pgs.)

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