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”?
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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)?
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3. This individual claims to be a “cancer researcher”
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If this individual’s “research” is so poor as a “cancer researcher,” what does that say about “research” re the “War on Cancer”?
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My review of C0nc0rdance:
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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?:
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)
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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”?
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http://www.burzynskiclinic.com/scientific-publications.html
Interim Reports on Clinial Trials:
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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
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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
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Critics, Cynics, “The Skeptics™”, what’s your survival rate?
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7. March 29, 1996
�
Then United States Food and Drug Administration Commissioner, David A. Kessler told the American people:
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1. We will eliminate unnecessary paperwork … that used to delay or discourage … cancer research … by non-commercial clinical investigators
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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
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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
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3. We will accept … less information … up front –
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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
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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
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6. The uhh agency has … many … trials … has has approved trials … for patients … with antineoplastons
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7. We are committed to providing expanded access … availability … for American patients for any drug … there’s reason to believe … may work
——————————————————————
Antineoplastons: Has the FDA kept its promise to the American people ?
——————————————————————
A. What is the FDA’s definition of “unnecessary paperwork”?
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B. What is the FDA’s definition of “smaller trials”?
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C. What is the FDA’s definition of “fewer patients”?
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D. What is the FDA’s definition of “evidence … of partial response“?
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E. What is the FDA’s definition of “less information … up front”?
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F. What is the FDA’s definition of “we’re going to require further study AFTER … approval”?
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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”?
�
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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?
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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”?
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10. Is this what the FDA means by:
if there is evidence … of partial response in clinical trials?
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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?
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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?
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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)
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pg 174
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2.3. Targeted Therapy
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1652 adults
335 children
[147]
�
indicates 1,799 Burzynski patients
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Is that what the FDA means by:
�
rely on … fewer patients?
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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:
Burzynski: Why has the FDA NOT granted Accelerated Approval for Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal) ?:
(Additional QUESTIONS being added)
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References:
1.
Post #73 – Didymus Judas Thomas
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:
“Burzynski naturally has lots of excuses for why the trial failed and tried to blame the investigators, but his complaints are not convincing.”
http://scienceblogs.com/insolence/2013/01/21/quoth-joe-mercola-i-love-me-some-burzynski-antineoplastons
Now, why don’t you tackle those ?’s?
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.”
18. “It is regrettable that, at the time of the study … the sponsor, NCI, decided against the higher dosing regimen that I proposed and closed the study.”
Stanislaw Rajmund Burzynski, M.D., Ph.D and “Freedom of Speech”
IMPORTANT: The live “debate” that wasn’t-A Film Producer, A Cancer Doctor, And Their Critics:
IMPORTANT: The live “debate” that wasn’t-A Film Producer, A Cancer Doctor, And Their Critics
Post #85 – Orac – April 28, 2013
“Well, DJT tried to comment last night and got caught in the moderation trap.”
“I’m not letting DJT through.”
“He’s been banned for very good reason, and I will not rescind the ban.”
http://scienceblogs.com/insolence/2013/04/26/all-truth-comes-from-public-debate-a-corollary-to-crank-magnetism/
My below blog contained a copy of the comment I submitted to his blog:
IMPORTANT: The live “debate”-A Film Producer, A Cancer Doctor, And Their Critics
All Mr. Hinton would have to do is ask “Orac” to respond to my post 73 on his blog, and it would be all over, since “Orac” has adopted his “Hold the Mayo” attitude, and shows no indication that he would ever be brave enough to touch it with the proverbial ZZ Top
“Ten Foot Pole”
because he’s probably aware of what would happen if he did
One of “Orac’s” “Oracolytes” posted on Forbes (#Forbes):
onforb.es/11pwse9
http://t.co/vh3cgAR6hW
“I already offered you a forum on a science blog to debate with a real respected surgical oncologist, with a guarantee that he never moderates the “debate”.”
http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics
IMPORTANT: The live “debate”-A Film Producer, A Cancer Doctor, And Their Critics:
IMPORTANT: The live “debate”-A Film Producer, A Cancer Doctor, And Their Critics
This is Dr. David H. Gorski’s blog
Dr. Gorski censored (blocked) my comments
We are supposed to believe that he’s now NOT going to block someone’s comments???
http://scienceblogs.com/insolence/2013/04/26/all-truth-comes-from-public-debate-a-corollary-to-crank-magnetism/
#66 – Didymus Judas Thomas
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”
“Burzynski naturally has lots of excuses for why the trial failed and tried to blame the investigators, but his complaints are not convincing”
http://scienceblogs.com/insolence/2013/01/21/quoth-joe-mercola-i-love-me-some-burzynski-antineoplastons
I challenged “Orac” about this and this reply was posted which included my point at the beginning of the reply:
1/29/2013
“An excellent explanation of how dubious Stanislaw Burzynski’s activities are”
Posted by Orac on January 28, 2013
http://scienceblogs.com/insolence/2013/01/28/an-excellent-explanation-of-how-dubious-stanislaw-burzynskis-activities-are
Post #52 – Orac
January 29, 2013
“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:
“Burzynski naturally has lots of excuses for why the trial failed and tried to blame the investigators, but his complaints are not convincing.”
http://scienceblogs.com/insolence/2013/01/21/quoth-joe-mercola-i-love-me-some-burzynski-antineoplastons
Now, why don’t you tackle those ?’s?
[SOURCE: Feb. 1999 Mayo Clinic Publication pg 2, 3 PDF]
Click to access Feb99MayoClinicPubANP.pdf
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 Objective:
http://www.mayoclinicproceedings.org/article/S0025-6196(11)63835-4/fulltext
To assess the pharmacokinetics, toxicity, and efficacy of antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261)
http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)63835-4
Design:
http://www.sciencedirect.com/science/article/pii/S0025619611638354
We initiated a phase II trial in order to determine whether evidence of antitumor activity of A10 and AS2-1 could be documented
Click to access PIIS0025619611638354.pdf
Comment in Jun; 74 (6): 641-2
http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.2003.01098.x/full
Mayo Clin Proc 74(2):9 (1999)
http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.2003.01098.x/references
1999 Elsevier Ltd.
http://onlinelibrary.wiley.com/store/10.1046/j.1365-2796.2003.01098.x/asset/j.1365-2796.2003.01098.x.pdf?v=1&t=hbs6xce2&s=3423e3cd1955667e8e8cdf33323faf0bd85b6a29
DOI: 10.4065/74.2.137
http://onlinelibrary.wiley.com/store/10.1046/j.1365-2796.2003.01098.x/asset/j.1365-2796.2003.01098.x.pdf?v=1&t=hbrndkdf&s=e0af2d3bfb13841852d92a839d3a4932a5f4bb48
Mayo Clin Proc 1999; 74: 137–45
Burzynski responded by pointing out:
6/1999 – A10 and AS2-1 – SRB http://www.ncbi.nlm.nih.gov/m/pubmed/10377942
Efficacy of antineoplastons A10 and AS2-1
S R Burzynski
Mayo Clin Proc 74 (6): 641-2 (1999),
Mayo Clin Proc. 1999 Jun; 74 (6): 641-2 Comment on Mayo Clin Proc. 1999 Feb; 74 (2): 137-45 PMID .10377942 Elsevier Science
http://www.mayoclinicproceedings.org/article/S0025-6196(11)64143-8/fulltext
Mayo Clinic Proc. 1999; 74: 641–642 (letter) 74 (6): 641-2
http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)64143-8
Mayo Clin Proc 74 (6): 1 (1999), 1999 Elsevier Ltd.
Click to access PIIS0025619611641438.pdf
DOI: 10.4065/74.6.641
This was responded to:
6/1999 – Mayo Clin Proc 74(6):2 (1999), DOI: 10.4065/74.6.641-a
http://www.mayoclinicproceedings.org/article/S0025-6196(11)64144-X/fulltext
Mayo Clinic Proceedings
Volume 74, Issue 6 , Pages 641-642, June 1999
Click to access PIIS002561961164144X.pdf
References:
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/
http://m.cancerres.aacrjournals.org/content/52/7/1988.abstract
http://cancerres.aacrjournals.org/content/52/7/1988
2. Danesi R, Nardini D, Basolo F, Del Tacca M, SAMID D . Myers CEo Phenylacetate inhibits protein isoprenylation and growth of the androgen-independent LNCaP prostate cancer cells transfected with the T24 Ha-ras oncogene. Mol Pharmacal. 1996; 49:972–979
http://www.ncbi.nlm.nih.gov/m/pubmed/8649357/
http://m.molpharm.aspetjournals.org/content/49/6/972.long
3. Chang SM, Kuhn LG, Robins HI, et al. Phase II study of phenylacetate in patients with recurrent malignant glioma: a North American Brain Tumor Consortium report. J Clin Oneal. 1999; 17:984–990
http://www.ncbi.nlm.nih.gov/m/pubmed/10071293/
http://m.jco.ascopubs.org/content/17/3/984.long
4. Thibault A, Cooper MR, Figg WD, et al. (SAMID D). A phase I and pharmacokinetic study of intravenous phenylacetate in patients with cancer. Cancer Res. 1994; 54:1690–1694
http://www.ncbi.nlm.nih.gov/m/pubmed/8137283/
http://m.cancerres.aacrjournals.org/content/54/7/1690.abstract
http://cancerres.aacrjournals.org/content/54/7/1690
PII: S0025-6196(11)64144-X
doi: 10.1016/S0025-6196(11)64144-X
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:
Click to access BurzynskiTriesToExposeNCI.pdf
Burzynski: Managing social conflict in complementary and alternative medicine research: the case of antineoplastons:
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2.
Antineoplastons: Phenylacetylglutaminate (PG or PAG), Phenylacetate (PN), and Phenylbutyrate (PB):
Antineoplastons: Phenylacetylglutaminate (PG or PAG), Phenylacetate (PN), and Phenylbutyrate (PB)
Phenylacetylglutamine (PG or PAG):
Phenylacetate (PN):
Phenylbutyrate (PB):
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Didymus Judas Thomas' Hipocritical Oath Blog 