Stanislaw Rajmund Burzynski, Stanislaw R. Burzynski, Stanislaw Burzynski, Stan R. Burzynski, Stan Burzynski, S. R. BURZYNSKI, S. Burzynski, Arthur Burzynski, Hippocrates Hypocrite Hypocrites Critic Critics Critical HipoCritical
Tag Archives: http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)64143-8
[1] – Wikipedia, claims:
—————————————————————— “There is a scientific consensus that antineoplaston therapy is unproven and of little promise in treating cancer””
—————————————————————— “… a Mayo Clinic study found no benefit from antineoplaston treatment.[1]””
—————————————————————— “The Memorial Sloan-Kettering Cancer Center has stated: “Bottom Line: There is no clear evidence to support the anticancer effects of antineoplastons in humans.”[1]””
——————————————————————
Interestingly, the above 1st claim by “Wikipedia” does NOT provide any specific citation(s), reference(s), or link(s) to support this claim
—————————————————————— [2] – 2/1999 – What “Wikipedia” does NOT advise the reader about the 2nd and 3rd claims, is that the conclusion of the study was:
“Although we could not confirm any tumor regression in patients in this study, the small sample size precludes definitive conclusions about treatment efficacy“
—————————————————————— [3] – 6/1999 – Wikipedia also does NOT point out that Burzynski replied to the 2/1999 publication, that:
[A] – Study tested dosing regimen known to be ineffective
[B] – Dosages of A10 and AS2–1 used in study were meant for treatment of single small lesion (<5 cm)
5 of the 6 evaluable patients had either multiple nodules or tumors larger than 5 cm
[C] – As the provider of A10 and AS2–1, I strongly suggested to the National Cancer Institute (NCI) that these patients receive a much higher dose, consistent with greater tumor load
[D] – Study was closed when I insisted the NCI either increase the dosage or inform the patients that the drug manufacturer believed that the treatment was unlikely to be effective at the dosages being used
(letter to Dr M. Sznol, NCI, on 4/20/1995)
[E] – Review of clinical data in the article by Buckner et al proves validity of my position
[F] – Study patients had extremely low plasma antineoplaston levels
My phase 2 study dosage regimen produced plasma phenylacetylglutamine (PG) levels 35 times greater, phenylacetylisoglutamine (isoPG) levels 53 times greater, and phenylacetate (PN) levels 2 times greater than those reported by Buckner et a1 [1]
[G] – Clinical outcomes reported by Buckner et al, based on inadequate dosage schedule, differ dramatically from my phase 2 studies in which higher dosage regimen was used
[H] – They reported no tumor regression
In contrast, in 1 of my ongoing studies on protocol BT-9, 4 of 8 evaluable patients with astrocytoma had objective responses [2]
[I] – Difference in outcomes primarily due to difference in dosage schedules
[J] – Another factor that may have caused a lack of response in the study by Buckner et al is duration of treatment was too brief
Almost all patients in their study received treatment for less than 30 days
1 patient received only 9 days of treatment
Current studies indicate objective tumor responses usually observed after 3 months of therapy
Additional 8 months of treatment usually needed to obtain maximal therapeutic effect
[K] – Ambiguities in response evaluation and analysis in article by Buckner et al
In.2 patients, tumor necrosis attributed to “radio-necrosis”
Interpretation’s clouded by fact antineoplaston-induced necrosis can be indistinguishable from radionecrosis
[L] – Analysis by Buckner et al could’ve highlighted 2 patients with recurrent glioblastoma who survived for more than 1 year
This is of interest because patients typically have life expectancy of 3 to 6 months
[M] – At time of the study by Buckner et al, the sponsor, NCI, decided against higher dosing regimen I proposed and closed the study
Study used dosing regimen known to be ineffective
====================================== [4] – 10/4/1991 – Five doctors (3 from the Cancer Therapy Evaluation Branch (CTEP); including the Head of the Quality Assurance and Compliance Section, Regulatory Affairs Branch, Cancer Therapy Evaluation Program, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, and 2 invited consultants; including one from the National Institutes of Health (NIH) Clinical Center) visited the offices of Dr. Stanislaw R. Burzynski
—————————————————————— [5] – 10/31/1991 – Michael A. Friedman, M.D. Associate Director, Cancer Therapy Evaluation Program (CTEP), Department of Health &Human Services, National Institutes of Health, National Cancer Institute, sent a one page Memorandum to Bruce A. Chabner, M.D., Director, Division of Cancer Treatment, which stated, in part:
“I thought you would be interested in this for several reasons:”
“3. Antineoplastons deserve a closer look”
“It turns out that the agents are well defined, pure chemical entities“
=======================================
======================================= “The human brain tumor responses are real”
======================================= [6] – 11/15/1991 – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, sent a 7 page letter to Decision Network, which stated, in part, on page one:
=======================================
======================================= “It was the opinion of the site visit team that antitumor activity was documented in this best case series … “
======================================= [7] – 12/2/91 – NCI (National Cancer Institute), Decision Network Report on Antineoplastons, states in part, on page 11:
=======================================
======================================= “The site visit team determined that antitumor activity was documented in this best case series … “
======================================= [8] – CANCER FACTS
National Cancer Institute • National Institutes of Health Department of Health and Human Services, Antineoplastons, pg. 1
=======================================
======================================= “The reviewers of this series found evidence of antitumor activity … “
======================================= [9] – Page 1 of 6, BlueCross BlueShield of Alabama, Antineoplaston Cancer Therapy, Policy #: 280, Category: Medicine, states, in part, on page 2 of 6:
Key Points:
=======================================
======================================= “The reviewers of this series found evidence of antitumor activity … “
=======================================
======================================= [10] – ANTINEOPLASTON THERAPY, HS-183, pg. 2
=======================================
======================================= “After the reviewers found some evidence of antitumor activity … “
=======================================
======================================= These facts indicate to me that Wikipedia’s claim about “antineoplastons”, is “debatable”
Maybe they should have learned how to use the Freedom of Information Act (FOIA)
======================================= REFERENCES:
======================================= [1]
—————————————————————— http://en.wikipedia.org/wiki/Burzynski_Clinic
—————————————————————— http://en.m.wikipedia.org/wiki/Burzynski_Clinic
——————————————————————
Antineoplastons, Memorial Sloan-Kettering Cancer Center
====================================== [2] – 2/1999 – A10 and AS2-1 – Phase II
Mayo Clinic Proceedings http://www.ncbi.nlm.nih.gov/m/pubmed/10069350
Phase II Study of Antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in Patients With Recurrent Glioma
Material & Methods:
Patients received escalating doses of A10 and AS2-1 by multiple intermittent intravenous injections with use of portable programmable pump to the target daily dose of 1.0 g/kg for A10 and of 0.4 g/kg for AS2-1
Mean steady-state plasma concentrations of phenylacetate & phenylacetylglutamine after escalation to the target doses of A10 and AS2-1 were 177 +/-101 ug/mL & 302 +/- 102 ug/mL, respectively
1. One “Orac” (Dr. David H. Gorski @oracknows @sciencebasedmed @gorskon #sciencebasedmedicine http://www.scienceblogs.com/Insolence http://www.sciencebasedmedicine.org)
claimed:
� “Burzynski naturally has lots of excuses for why the trial failed and tried to blame the investigators, but his complaints are not convincing.”
� When I requested that he respond to Burzynski’s comments re the study, he would NOT touch it with the proverbial ZZ Top
� “Ten-Foot Pole”
� What Critic, Cynic, or one of “The Skeptics™” is going to show more Bravery and Courage than “Orac”?
� � � � � � � � � � � � � � � � �
2. If antineoplastons do NOT work, why, after Dvorit D. SAMID learned of them from Burzynski, did all the research, clinical studies, and phase I, phase II, and phase III clinical trials really start to get underway on PHENYLACETYLGLUTAMINATE (PAG or PG)
PHENYLACETATE (PN)
and PHENYLBUTYRATE (PB)?
� � � � � � � � � � � � � � � � �
3. This individual claims to be a “cancer researcher”
�
If this individual’s “research” is so poor as a “cancer researcher,” what does that say about “research” re the “War on Cancer”?
� My review of C0nc0rdance: https://stanislawrajmundburzynski.wordpress.com/2013/03/23/my-review-of-c0nc0rdance/
� � � � � � � � � � � � � � � � �
4. This individual claims to be a “Doctor,” “oncologist,” “breast cancer specialist,” and “cancer researcher”
�
If this individual’s “research” is so poor as a “cancer researcher,” what does that say about “research” re the “War on Cancer”?
� Paging Doctor David H. Gorski, Paging Doctor David H. Gorski: There’s Mud in your Ears … Doktor Gorski?: https://stanislawrajmundburzynski.wordpress.com/2013/05/28/paging-doctor-david-h-gorski-paging-doctor-david-h-gorski-theres-mud-in-your-ears-doktor-gorski/
He did NOT even refer to the below publication by Burzynski regarding “Treatment of Recurrent Triple-Negative Breast Cancer:”
�
8/2011 – Successful Treatment of Recurrent Triple-Negative Breast Cancer with Combination of Targeted Therapies http://www.scirp.org/journal/PaperDownload.aspx?DOI=10.4236/jct.2011.23050
Journal of Cancer Therapy, 2011, 2, 372-376
doi:10.4236/jct.2011.23050 Published Online August 2011
(http://www.SciRP.org/journal/jct)
� � � � � � � � � � � � � � � � �
5. Critics, Cynics, “The Skeptics™” state that Burzynski is NOT an oncologist, but can offer no explanation as to why this is supposedly “relevant,” they cannot explain if oncologists are somehow “better” than biochemists, nor do they want to answer the question:
�
“Does Burzynski work with any oncologists, and are any of them listed on his phase II clinical trial publications”?
� http://www.burzynskiclinic.com/scientific-publications.html
Interim Reports on Clinial Trials:
�
16. 2003
�
DRUGS IN R&D
Drugs in R and D
(Drugs in Research and Development)
� BT-11
� BRAIN STEM GLIOMA
�
Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA:
�
a preliminary report. http://www.ncbi.nlm.nih.gov/pubmed/12718563 Burzynski, S.R.
Lewy, R.I.
Weaver, R.A.
Axler, M.L.
Janicki, T.J.
Jurida, G.F.
Paszkowiak, J.K.
Szymkowski, B.G.
Khan, M.I.
Bestak, M. http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs R D. 2003;4(2):91-101
Drugs in R&D 2003;4:91-101
� � � � � � � � � � � � � � � � �
6. The British Broadcasting Corporation (BBC) Panorama program indicated that 776 Burzynski patients with brain tumours were treated in trials before 2008 http://t.co/nFpwlQg275 15.5% (120) survived more than 5 years
�
Critics, Cynics, “The Skeptics™”, what’s your survival rate?
� � � � � � � � � � � � � � � � �
7. March 29, 1996
�
Then United States Food and Drug Administration Commissioner, David A. Kessler told the American people:
�
1. We will eliminate unnecessary paperwork … that used to delay or discourage … cancer research … by non-commercial clinical investigators
�
2. The … FDA’s initiatives … will allow …the agency … to rely on smaller trials … fewer patients … if there is evidence … of partial response in clinical trials
�
I don’t want to get into any particular … agent … except let me point out … that … the information needs to be part … of clinical trials
�
3. We will accept … less information … up front –
�
4. we’re going to require further study AFTER … approval … because the science … has matured
�
5. The important – point … is that information needs to be gathered … through scientific means … through clinical – trials … and I think – that’s … that’s very important uhh very … important point
�
You can’t … just … use an agent here – or there … you have to use it … as part of a clinical trial … so we can get information … on whether the drug works
�
6. The uhh agency has … many … trials … has has approved trials … for patients … with antineoplastons
�
7. We are committed to providing expanded access … availability … for American patients for any drug … there’s reason to believe … may work
—————————————————————— https://stanislawrajmundburzynski.wordpress.com/2013/03/22/antineoplastons-has-the-fda-kept-its-promise-to-the-american-people
——————————————————————
A. What is the FDA’s definition of “unnecessary paperwork”?
�
B. What is the FDA’s definition of “smaller trials”?
�
C. What is the FDA’s definition of “fewer patients”?
�
D. What is the FDA’s definition of “evidence … of partial response“?
�
E. What is the FDA’s definition of “less information … up front”?
�
F. What is the FDA’s definition of “we’re going to require further study AFTER … approval”?
�
G. What is the FDA’s definition of “We are committed to providing expanded access … availability … for American patients for any drug … there’s reason to believe … may work”?
� https://stanislawrajmundburzynski.wordpress.com/2013/06/08/what-is-misdirection-critiquing-antineoplastons-has-the-fda-kept-its-promise-to-the-american-people/
� � � � � � � � � � � � � � � � �
8. The British Broadcasting Corporation (BBC) Panorama program indicated that 776 Burzynski patients with brain tumours were treated in trials before 2008 http://t.co/nFpwlQg275
Is that what the FDA means by:
�
rely on … fewer patients?
� � � � � � � � � � � � � � � � �
9. 4/27/2013 (37:20) Fabio stated that
Burzynski had provided the FDA with 2.5 million pages of clinical trial documents
Is that what the FDA means by:
� “unnecessary paperwork”?
�
and
� “less information … up front”?
� � � � � � � � � � � � � � � � �
10. Is this what the FDA means by: https://stanislawrajmundburzynski.wordpress.com/2013/06/08/what-is-misdirection-critiquing-antineoplastons-has-the-fda-kept-its-promise-to-the-american-people/
if there is evidence … of partial response in clinical trials?
� � � � � � � � � � � � � � � � �
11. Why was the United States Food and Drug Administration requiring that radiation be used in the Phase 3 Clinical Trial when Burzynski has shown better results with antineoplastons when radiation is NOT used?
� � � � � � � � � � � � � � � � �
12. Who wants to defend the excuse that The Lancet gave for NOT Publishing the documentation which Burzynski sent to them, which is referred to in Burzynski: Cancer is Serious Business, Part II?
� � � � � � � � � � � � � � � � �
13. Review Articles on Clinical Trials: 2. 2006 – Treatments for Astrocytic Tumors in Children: Current and Emerging Strategies. Pediatric Drugs 2006;8:167-178.
2006 Adis – Pediatr Drugs 2006; 8 (3)
� pg 174
� 2.3. Targeted Therapy
� 1652 adults
335 children
[147]
�
indicates 1,799 Burzynski patients
�
Is that what the FDA means by:
�
rely on … fewer patients?
� � � � � � � � � � � � � � � � �
13. The FDA approved phase III (3) clinical trials for Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal); which means that they have shown evidence of effectiveness, yet they have NOT granted Accelerated Approval for them, even though they have done so for other treatments which had NOT yet published the final results of phase II (2) clinical trials, and which did NOT have as good Complete Response, Partial Response, Stable Disease, Minor Response, Progressive Disease, Objective Response, Progression-Free Survival, etc., rates:
At the Tu-Quack Center Oracles of Deny to Respond tree
1/30/2013
Post #52 – Orac
“You do realize that that means that the Mayo trial failed to find evidence of efficacy, just as I said, don’t you?”
“The default of a finding like that is that there is no evidence of efficacy, not that failure to have adequate numbers to show an effect means that there’s an effect there”
“If SRB wants to convince skeptics that his treatments work better than conventional therapy, let him publish the evidence in a peer-reviewed journal in a manner that it can be independently verified”
“Thus far, he has failed to do so.”
Orac, I thoroughly enjoyed; with a dismissive limp wrist, you posted:
1. “[T]he study tested a dosing regimen known to be ineffective.”
2. “[D]osages used in the study “were meant for the treatment of a single small lesion…”
3. “5 of the 6 evaluable patients had either multiple nodules or tumors larger than” said single small lesion.
4. “As the provider,” SRB “strongly suggested to the NCI that these patients receive a much higher dose, consistent with their greater tumor load.”
5. “[T]he study was closed when” SRB “insisted that the NCI either increase the dosage or inform the patients that the drug manufacturer believed that the treatment was unlikely to be effective at the dosages being used (letter to Dr M. Sznol, NCI, on 4/20/1995).”
6. “A review of the clinical data in the article … proves the validity of” SRB’s “position” per SRB
7. “Their study patients had extremely low plasma antineoplaston levels.”
8. SRB’s “phase 2 study dosage regimen produced plasma phenylacetylglutamine levels that are 35 times greater, phenylacetylisoglutamine levels 53 times greater, and phenylacetate levels 2 times greater than those reported…’”
9. “The clinical outcomes reported … based on their inadequate dosage schedule, differ dramatically from” SRB’s “phase 2 studies in which a higher dosage regimen was used.”
10. “They reported no tumor regression. In contrast, in 1 of” SRB’s “ongoing studies on protocol BT-9, 4 of 8 evaluable patients with astrocytoma had objective responses.’”
11. “The difference in outcomes is primarily due to the difference in dosage schedules,” per SRB
12. “Another factor that may have caused a lack of response in the study by … is that the duration of treatment was too brief.”
13. “Almost all the patients in their study received treatment for less than 30 days.”
14. “1 patient received only 9 days of treatment.”
15. “The current studies indicate that objective tumor responses are usually observed after 3 months of therapy.”
16. “An additional 8 months of treatment is usually needed to obtain a maximal therapeutic effect.”
17. “[A]mbiguities in the response evaluation and analysis in the article…”
a) “In 2 patients, tumor necrosis was attributed to “radionecrosis.””
b) “However, such an interpretation is clouded by the fact that antineoplaston-induced necrosis can be indistinguishable from radionecrosis.”
c) “Moreover, the analysis … could have highlighted the 2 patients with recurrent glioblastoma who survived for more than I year.”
d) “This is of interest because these patients typically have a life expectancy of 3 to 6 months.”
IMPORTANT: The live “debate”-A Film Producer, A Cancer Doctor, And Their Critics | Didymus Judas Thomas’ Hipocritical Oath Blog
April 27, 2013
Your comment is awaiting moderation.
Seriously ? Gorski ? Let’s remember that it is YOU who would NOT answer my questions, and instead inacted your “Hold the Mayo” posture re post 73
Let’s review your
“deconstructed his “evidence” in depth before” claim
1/21/2013 Orac posted THIS blog:
“Quoth Joe Mercola:
I love me some Burzynski antineoplastons
Posted by Orac on January 21, 2013″
” … In particular, a multicenter phase II trial carried out by investigators at the Mayo Clinic was a big failure, with a median survival of 5.2 months in patients with anaplastic oligoastrocytoma, anaplastic astrocytoma, or glioblastoma multiforme that had recurred after radiation therapy”
“CONCLUSION: Although we could not confirm any tumor regression in patients in this study, THE SMALL SAMPLE SIZE PRECLUDES DEFINITIVE CONCLUSIONS ABOUT TREATMENT EFFICACY.”
“You do realize that that means that the Mayo trial failed to find evidence of efficacy, just as I said, don’t you?”
“The default of a finding like that is that there is no evidence of efficacy, not that failure to have adequate numbers to show an effect means that there’s an effect there”
“If SRB wants to convince skeptics that his treatments work better than conventional therapy, let him publish the evidence in a peer-reviewed journal in a manner that it can be independently verified”
“Thus far, he has failed to do so”
I responded to Orac, quoting his reply at the beginning of my reply:
Post #73 – Didymus Judas Thomas
At the Tu-Quack Center Oracles of Deny to Respond tree
January 30, 2013
Post #52 – Orac
“You do realize that that means that the Mayo trial failed to find evidence of efficacy, just as I said, don’t you?”
“The default of a finding like that is that there is no evidence of efficacy, not that failure to have adequate numbers to show an effect means that there’s an effect there”
“If SRB wants to convince skeptics that his treatments work better than conventional therapy, let him publish the evidence in a peer-reviewed journal in a manner that it can be independently verified”
“Thus far, he has failed to do so”
Orac, I thoroughly enjoyed; with a dismissive limp wrist, you posted:
1. SAMID D , Shack S, Sherman LT. Phenylacetate: a novel nontoxic inducer of tumor cell differentiation. Cancer Res . 1992; 52:1988–1992 http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/
1999 Mayo Foundation for Medical Education and Research.
Elsevier Inc.
The above four (4) references in the response to Burzynski might be relevant if all that antineoplastons consisted of was phenylacetate
Phenylacetylglutaminate (PAG or PG) and Phenylacetate (PN) are metabolites of Phenylbutyrate (PB) and are constituents of antineoplaston AS2-1
Antineoplastons AS2-1 and AS2-5 are DERIVED FROM A10
AS2-1=4:1 mixture of PHENYLACETIC ACID (PA) and Phenylacetylglutamine (PAG or PG)
National Cancer Institute (NCI) at the National Institutes of Health (NIH) Antineoplastons
General Information: http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page2 This is “what would happen” if “Orac” did have the “Bravery,” “Courage,” “Gumption,” “Intestinal Fortitude,” “Testicular Fortitude,” to address this issue:
Didymus Judas Thomas' Hipocritical Oath Blog 