March 14, 2013 David Gorski posted on ScienceBasedMedicine . org [1] and ScienceBlogs . com/Insolence [2]
3.
“Merola bemoans how unfair it is (to him) that the FDA is requiring a phase III clinical trials for Burzynski’s antineoplastons and refusing to grant accelerated approval for them, as it did for Temodar and Avastin”
“It seems like a compelling point on the surface if you don’t know about the drug approval process or Burzynski; indeed, The Skeptics who viewed the movie wondered about this claim”
“Here’s what, as far as I can tell from my reports, Merola leaves out”
“Temodar and Avastin both had proper, completed, and published phase II trials before approval”
Does Gorski provide a reference to support his statement ?
“Temodar and Avastin both had proper, completed, and published phase II trials before approval”
NO !
Does he provide a citation ?
NO !!
Does he provide a link ?
NO !!!
Why not ?
Is it because Science Based Medicine . org proclaims:
“Our only goal is to promote high standards of science in medicine” ? [3]
Is it because “Orac” is god ??
Is it because Gorski has proclaimed:
6/5/2013 “ … I do know cancer science”??? [4]
Is it because “Orac” says:
6/7/2013 “Unlike Mr. Merola, I am indeed very concerned with getting my facts correct” ???? [5]
1/1999 Temodar (Temozolomide): received accelerated approval by the U.S. Food and Drug Administration for treatment of anaplastic astrocytoma (brain cancer) patients [6]
Was the United States Food and Drug Administration’s 1/1999 accelerated approval based on the PUBLISHED FINAL RESULTS OF A PHASE II (2) CLINICAL TRIAL?
The answer is: NO
1/1999 – FDA Accelerated Approval [6]
9/1999 – Phase 2 publication [7]
12/2000 – publication [8]
5/6/2009 U.S. Food and Drug Administration (FDA) granted accelerated approval of Avastin (bevacizumab) for people with glioblastoma (brain cancer) with progressive disease following prior therapy [9]
Was the United States Food and Drug Administration’s 5/6/2009 accelerated approval based on the PUBLISHED FINAL RESULTS OF A PHASE II (2) CLINICAL TRIAL?
.2/10/2009 – 1st arm Phase 2 publication [10]
5/6/2009 – FDA Accelerated Approval [9]
1/1/2010 – 2nd arm publication [11]
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
So, Gorski has been caught in yet another LIE
But no worries !
5/31/2013 Orac posted:
“Burzynski has a contingent of defenders who have targeted skeptics like me for special abuse, up to and including harassing me at work by calling my university to complain about my online verbiage critical of Burzynski and implying that I am somehow doing something wrong”
“(My university quickly realized that I was not.)” [12]
Gorski obviously has carte blanche to LIE
I wonder what
Wayne State University
Wayne State University School of Medicine
Section of Breast Surgery / Graduate Program in Cancer Biology
Barbara Ann Karmanos Cancer Center / Institute
Alexander J. Walt Comprehensive Breast Center
American College of Surgeons Committee on Cancer
Institute for Science in Medicine
National Geographic
ScienceBlogs . com
and
ScienceBasedMedicine . org
all think of this, knowing that they could become the next
“wretched hive of scum and hackery ?”
David H. Gorski, MD, PhD, FACS,
maybe you should check your FACTS
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[1] Burzynski: Cancer Is A Serious Business, Part 2: Like the first Burzynski movie, only more so?
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http://www.sciencebasedmedicine.org/burzynski-cancer-is-a-serious-business-part-2-like-the-first-burzynski-movie-only-more-so/
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[2] Five things I learned (second hand) from the recent screening of Burzynski: Cancer Is Serious Business, Part 2
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http://scienceblogs.com/insolence/2013/03/14/five-things-i-learned-second-hand-from-the-recent-screening-of-burzynski-cancer-is-serious-business-part-2/
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[3] ScienceBasedMedicine Editorial Staff
——————————————————————
http://www.sciencebasedmedicine.org/editorial-staff/
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[4] Odds and Ends about Burzynski Clinic
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http://scienceblogs.com/insolence/2013/06/05/odds-and-ends-about-burzynski-clinic/
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[5] I want my ANP
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http://scienceblogs.com/insolence/2013/06/07/i-want-my-anp/
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[6] 1/1999 Temodar (Temozolomide): received accelerated approval by the U.S. Food and Drug Administration
——————————————————————
http://clincancerres.aacrjournals.org/content/11/19/6767.full
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[7] 9/1999 – Multicenter phase II trial of temozolomide in patients with anaplastic astrocytoma or anaplastic oligoastrocytoma at first relapse
Temodal Brain Tumor Group
http://www.ncbi.nlm.nih.gov/pubmed/10561351/
J Clin Oncol. 1999 Sep;17(9):2762-71.
http://www.ncbi.nlm.nih.gov/m/pubmed/10561351/
JCO September 1999 vol. 17 no. 9 2762
http://m.jco.ascopubs.org/content/17/9/2762.abstract
ERRATA: Correction for vol. 17, p. 2762 JCO Nov 1, 1999:3693
http://m.jco.ascopubs.org/content/17/9/2762.long
University of Texas M.D. Anderson Cancer Center, Houston, TX, USA
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[8] 12/2000 – Temozolomide and anaplastic astrocytoma:
new indication
http://www.ncbi.nlm.nih.gov/pubmed/11475493/
Prescrire Int. 2000 Dec;9(50):170-1.
http://www.ncbi.nlm.nih.gov/m/pubmed/11475493/
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[9] 5/6/2009 U.S. Food and Drug Administration (FDA) granted accelerated approval of Avastin (bevacizumab)
——————————————————————
http://www.drugs.com/newdrugs/fda-grants-accelerated-approval-avastin-brain-cancer-glioblastoma-has-progressed-following-prior-1342.html
Study AVF3708g
http://www.cancer.gov/cancertopics/druginfo/fda-bevacizumab
Study NCI 06-C-0064E
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[10] .2/10/2009 Phase II Trial of Single-Agent Bevacizumab Followed by Bevacizumab Plus Irinotecan at Tumor Progression in Recurrent Glioblastoma
http://www.ncbi.nlm.nih.gov/pubmed/19114704/
J Clin Oncol. 2009 Feb 10;27(5):740-5. doi: 10.1200/JCO.2008.16.3055
http://www.ncbi.nlm.nih.gov/m/pubmed/19114704/
Epub 2008 Dec 29
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2645088/
JCO February 10, 2009 vol. 27 no. 5 740-745
http://m.jco.ascopubs.org/content/27/5/740
Published online before print December.29, 2008, doi: 10.1200/JCO.2008.16.3055
http://m.jco.ascopubs.org/content/27/5/740.long
Neuro-Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA
http://m.jco.ascopubs.org/content/27/5/740.full
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[11] 1/1/2010 Bevacizumab: in previously treated glioblastoma
http://www.ncbi.nlm.nih.gov/pubmed/20108991/
Drugs. 2010;70(2):181-9. doi: 10.2165/11203890-000000000-00000
http://www.ncbi.nlm.nih.gov/m/pubmed/20108991/
Drugs January 2010, Volume 70, Issue 2, pp 181-189
http://link.springer.com/article/10.2165%2F11203890-000000000-00000
Adis, a Wolters Kluwer Business, Auckland, New Zealand
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[12] On “helping” that is anything but
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http://scienceblogs.com/insolence/2013/05/31/on-helping-that-is-anything-but/
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