FDA Accelerated Approval: September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51

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BB – Bob Blaskiewicz ——————————————————————
DJT – Didymus Judas Thomas
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0:29:00
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BB – “Who had the better results ?” [1]
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DJT – Well, I would have to find you one, there were like 3
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BB – “Okay”
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DJT – There were like 3 major ones that Burzynski has mentioned in his publications to cross-reference his trials versus their trials as far as the results [2]
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radiation therapy and chemotherapy with cisplatin
(Mandell et al.) (6/1992 – 10/1997) [65]
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Low dose thalidomide and temodar
(Phuphanich, et al.) [66]
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recurrent Glioblastoma Multiforme (GBM) with newest forms of Chemotherapy
(Prados et al.) [67]
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DJT – And so, I, there was one back in 1999 that had better results than a lot of these clinical trials that come afterwards [3]

So when we talk about, you know, what’s really right for the patients well we can see that the drug companies want to test their drugs through clinical trials and, you know, and if your kid dies, well, unfortunately the kid dies

Even though we showed better results in 1999 with a different type of treatment, you would have thought that maybe they would have poured more investment into that particular treatment but that’s not necessarily how the clinical trial system works
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0:30:00
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0:32:07
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BB“When you, when you think about a major, sorry, go ahead”
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0:33:03
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DJT – And plus, like I’ve said before
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BB“Yeah, right, uh”
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DJT – We’ve still got the accelerated approval thing that’s out there, you know, like the FDA’s given Temodar and, and Avastin, and another drug, whereas they’re not doing the same thing for antineoplastons, eve even though for all intents and purposes from what we know, antineoplastons have had better success rates than Temodar and Avastin when they were approved
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BB – “Antineoplastons has a better rate ?”
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DJT – Well from the information that’s been published in certain um publications
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BB – “Right”
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DJT – And in, and in not only Burzynski’s but elsewhere in, in newspapers or articles, or such like that
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BB – “Right, one of the things that that there there are 2 points to be made here”

“Uhm, the 1st one is that major pharmaceutical companies that are getting this accelerated approval have a track record of producing results which Burzynski does not have

“Secondly, when it comes to ummm the rates of antineoplastons, how can we possibly say without a single published trial he, that he has an improved rate over Temodar or anything like that, and that’s exactly what would show to us whether or not his rate is better, the the types of publications that he’s done, that look really good on paper, ummm, to the to the, the common persons eye are these case series where he goes through and picks out people who have happened to have survived”
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0:34:47
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BB“But what that doesn’t tell us is whether or not the antineoplaston had anything to do with it”

“What you need to do is go and separate the background noise, the random weird rare but very real survive, unexpected survivals that occur, and separate those, uhhh, from any effect of antineoplaston, he’s never done that”
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0:35:10
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DJT – Well what I found interesting is when the FDA approved these other 1 or 2 drugs, some of them specifically said that, uhhh, some of these drugs had, you know, (no) better survivability or they showed no better rate than any previous treatment but we’re approving it anyway

Basically that’s what the publication said and I published this on my blog in an article specifically about, you know, those 2 or 3 drugs that the FDA approved for brainstem or brain related cancers

And so, you know, I’m not going to buy that argument about that, about that specific thing [4-6]
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Temodar (Temozolomide):
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1/1999Temozolomide received accelerated approval by the U.S. Food and Drug Administration for treatment of ANAPLASTIC ASTROCYTOMA (brain cancer) patients
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At time of approval, NO RESULTS were available from randomized controlled trials in refractory ANAPLASTIC ASTROCYTOMA that show clinical benefit such as improvement in disease-related symptoms or prolonged survival
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1/1999 – Was the United States Food and Drug Administration’s accelerated approval based on the PUBLISHED FINAL RESULTS OF A PHASE II (2) CLINICAL TRIAL?
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NO

1/1999FDA Accelerated Approval

9/1999Phase 2 publication

12/2000publication
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9/1999 – Multicenter phase II trial of temozolomide in patients with ANAPLASTIC ASTROCYTOMA or anaplastic oligoastrocytoma at first relapse

Temodal Brain Tumor Group

All investigators concurred that a 6-month end point was appropriate in the GBM setting because, at that time,
most patients failed to respond to the drug

University of Texas M.D. Anderson Cancer Center, Houston, TX, USA
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12/2000Temozolomide and ANAPLASTIC ASTROCYTOMA:

new indication

NO CLEAR PROOF OF EFFICACY
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NO BETTER THAN SURVIVAL BEFORE THE INTRODUCTION OF temozolomide
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2004 – Supratentorial high-grade ASTROCYTOMA and DIFFUSE BRAINSTEM GLIOMA:

two challenges for the pediatric oncologist

The addition of chemotherapy seems to improve the survival of a subset of these children, particularly those with glioblastoma multiforme

2-year survival rates remain poor for children with supratentorial neoplasms, ranging from 10%-30%

Less than 10% of children with diffuse brainstem gliomas survive 2 years

Despite aggressive treatment approach, outcome for children with these tumors remains poor; long-term survival rates range from <10%to 30% for most supratentorial tumors and are <10% for diffuse brainstem gliomas

Division of Neuro-Oncology, Department of Hematology-Oncology, St. Jude Children’s Research Hospital, Memphis, Tennessee, USA
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1/1/2005 (11/24/2004) – Role of temozolomide after radiotherapy for newly diagnosed diffuse BRAINSTEM GLIOMA in children:

results of a multiinstitutional study (SJHG-98)

Department of Hematology-Oncology, St. Jude Children’s Research Hospital, Memphis, Tennessee, USA
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administration of temozolomide after RT DIDN’T ALTER POOR PROGNOSIS associated with newly diagnosed diffuse BRAINSTEM GLIOMA in children

All (33) patients died of disease progression (median survival, 12 months)

estimated 1-year survival rate was 48%
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Avastin (Bevacizumab):
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5/6/2009U.S. Food and Drug Administration (FDA) granted accelerated approval of Avastin (bevacizumab) for people with GLIOBLASTOMA (brain cancer) with progressive disease following prior therapy

Currently, NO DATA available from randomized controlled trials demonstrating improvement in disease-related symptoms or increased survival with Avastin in GLIOBLASTOMA
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5/6/2009 – Was the United States Food and Drug Administration’s accelerated approval based on the PUBLISHED FINAL RESULTS OF A PHASE II (2) CLINICAL TRIAL?
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.2/10/20091st arm Phase 2 publication

5/6/2009FDA Accelerated Approval

1/1/20102nd arm publication

The answer is: The 1st arm of the phase 2 clinical trial was published .2/10/2009, before the 5/6/2009 FDA approval, and the 2nd arm was published 1/1/2010, after the FDA approval
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Study NCI 06-C-0064E
All patients had documented disease progression after receiving temozolomide and radiation therapy

Efficacy of Avastin in GLIOBLASTOMA that progressed following prior therapy supported by another study that used same response assessment criteria as AVF3708g
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Afinitor (Everolimus):
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Afinitor (ubependymal giant cell ASTROCYTOMA (SEGA) brain tumor)
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10/29/2010FDA granted accelerated approval for Afinitor (Novartis) after single Phase 2 study of only 28 patients
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none of their tumors went away completely
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10/29/2010 – Was the United States Food and Drug Administration’s accelerated approval based on the PUBLISHED FINAL RESULTS OF A PHASE II (2) CLINICAL TRIAL?
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NO

10/29/2010FDA Accelerated Approval

10/12/2011publication
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10/12/2011 (8/1/2011) – Everolimus tablets for patients with
subependymal giant cell ASTROCYTOMA

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BB“But if you think about that, I mean that if it does have a a an improvement rate above uh other treatments”
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0:36:03
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BB“That still has an improvement rate, you know, that, that would give another option to people, ummm, even if in the aggregate their rates aren’t better”

“It might work on some individuals tumors rather than on, you know, you you it it is it taken as a, as a lump but extend life by uh quality of life for 3 months or something um in some cases but, you know, it it still has an effect, a real effect, and deserves to be out there”
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DJT – Well one of these newspaper articles specifically said, you know, Avastin would maybe keep you alive for maybe 4 more months

So, you know, take that
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BB – “That’s a long time when someone is dying”
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0:37:02
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See [3]
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REFERENCES:
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[1] – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
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https://stanislawrajmundburzynski.wordpress.com/2013/10/04/september-28-2013-the-skeptics-burzynski-discussion-by-bob-blaskiewicz-21951/
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[2] – Review Articles on Clinical Trials:
1. 3/2004
INTEGRATIVE CANCER THERAPIES
The Present State of Antineoplaston Research
Integrative Cancer Therapies 2004;3:47-58
Volume 3, No. 1, March 2004
DOI: 10.1177/1534735-403261964

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http://www.burzynskiclinic.com/images/stories/Publications/994.pdf
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[3] – Critiquing https://theotherburzynskipatientgroup.wordpress.com
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https://stanislawrajmundburzynski.wordpress.com/2013/08/24/critiquing-httpstheotherburzynskipatientgroup-wordpress-com/
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[4] – Burzynski: Why has the FDA NOT granted Accelerated Approval for Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal) ?:
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https://stanislawrajmundburzynski.wordpress.com/2013/07/28/burzynski-why-has-the-fda-not-granted-accelerated-approval-for-antineoplastons-a10-astengenal-and-as2-1-astugenal/
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[5] – Wayne State University, Detroit, Michigan, quickly realized that David H. Gorski, MD, PhD, FACS is NOT doing something wrong when he LIES about Burzynski:
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https://stanislawrajmundburzynski.wordpress.com/2013/08/27/wayne-state-university-detroit-michigan-quickly-realized-that-david-h-gorski-md-phd-facs-is-not-doing-something-wrong-when-he-lies-about-burzynski/
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[6] – Orac’s “Oracolyte” Narad proves he has the research skilz of his “god”:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/08/oracs-oracolyte-narad-proves-he-has-the-research-skilz-of-his-god/
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