Critiquing: Stanislaw Burzynski in USA Today: Abuse of clinical trials and patients versus the ineffectiveness of the FDA and Texas Medical Board (swell inflammation phenomenon)

Posted on November 20, 2013 by didymusjudasthomas

Liz Szabo’s USA TODAY “killer cancer” article as interpreted by “Orac” made 3 claims [0]:
——————————————————————
“Conventional cancer treatment can also cause tumors to swell temporarily,” [1]

“due to”

“inflammation,” [2]

“A patient who isn’t familiar with this”

“phenomenon” [3]

“may assume her tumor is growing”
——————————————————————
The issue with citing these 3 studies is that each then needs to be reviewed to determine if they have any relevance to the patients Burzynski has treated in the phase II clinical trials:
——————————————————————
[1] – 12/2009 – Pseudoprogression and pseudoresponse in the treatment of gliomas
——————————————————————
1. Has Burzynski treated patients with gliomas, brain tumours, or recurrent glioblastoma ?
——————————————————————
2. Has Burzynski’s patients been treated with combined chemo-irradiation with temozolomide which may induce in 20-30% ?
——————————————————————
[2] – 5/2008 – Clinical features, mechanisms, and management of pseudoprogression in malignant gliomas
——————————————————————
1. Has Burzynski treated patients with glioblastoma ?
——————————————————————
2. Have any of Burzynski’s patients been treated with temozolomide chemoradiotherapy ?
——————————————————————
3. so-called pseudoprogression
can occur in up to 20% of patients
——————————————————————
4. can explain about 1/2 of 20%
——————————————————————
[3] – In support of this “phenomenon”, the article provides a link to a Canadian web-site which
posits:
——————————————————————
“RT/TMZ is now widely practiced and the standard of care for appropriately selected patients, we are learning more about the consequences of RT/TMZ”

“One phenomena, termed Pseudo-Progression (psPD)…”
——————————————————————
The problem is that this only applies to “Glioblastoma Multiforme (GBM)”, and the article provides NO proof whatsoever, that any of Burzynski’s “Glioblastoma Multiforme (GBM)” patients have taken “RT/TMZ”
——————————————————————
Additionally, the site cites the reference as:

Sanghera, Perry, Sahgal, et al., “Sunnybrook Health Sciences Odette Cancer Centre” (in press, Canadian Journal of Neuroscience)

(“In press” refers to journal articles which have been accepted for publication, but have not yet been published)

However, the journal article in question was published 1/2010, so it has NOT been “in press” for over 3 years and 7 months [4]
——————————————————————
GorskGeek stupidly suppositories:
——————————————————————
“It’s very heartening to see a story like this in a major news outlet, and I must congratulate Ms. Szabo for her thorough deconstruction of the phenomenon that is Stanislaw Burzynski“
——————————————————————
GorskGeek, just because a great portion of Liz Szabo’s USA TODAY article quoted verbatim from The Skeptics™ play book, does
NOT mean she was anymore successful at “deconstructing” Burzynski [5], anymore than you have NOT
——————————————————————
GorskGeek then regurgitates:
——————————————————————
“Remember how I said that Bob Blaskiewicz will want your help?”

“Now’s the time to contact him, if you haven’t already”
——————————————————————
GorskGeek, Bob Blaskiewicz needs “HELP” in the same manner as you need “HELP”, because, as I have proved, you both act like compulsive liars
======================================
REFERENCES:
======================================
[0] – 11/15/2013 – Stanislaw Burzynski in USA Today: Abuse of clinical trials and patients versus the ineffectiveness of the FDA and Texas Medical Board
——————————————————————
http://scienceblogs.com/insolence/2013/11/15/stanislaw-burzynski-in-usa-today-abuse-of-clinical-trials-and-patients-versus-the-ineffectiveness-of-the-fda-and-texas-medical-board/
======================================
[1] – 12/2009 – Pseudoprogression and pseudoresponse in the treatment of gliomas
pseudo-phenomenona
——————————————————————
http://www.ncbi.nlm.nih.gov/pubmed/19770760/
——————————————————————
Curr Opin Neurol. 2009 Dec;22(6):633-8. doi: 10.1097/WCO.0b013e328332363e
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/19770760/
——————————————————————
Department of Neuro-Oncology, Antoni van Leeuwenhoek Hospital/Netherlands Cancer Institute, Amsterdam, The Netherlands
======================================
[2] – 5/2008 – Clinical features, mechanisms, and management of pseudoprogression in malignant gliomas
——————————————————————
http://www.ncbi.nlm.nih.gov/pubmed/18452856/
——————————————————————
Lancet Oncol. 2008 May;9(5):453-61. doi: 10.1016/S1470-2045(08)70125-6
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/18452856/
——————————————————————
Department of Neuro-oncology, Daniel den Hoed Cancer Centre, Erasmus Medical Centre, Rotterdam, Netherlands
——————————————————————
http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(08)70125-6/fulltext
——————————————————————
occurs more frequently and earlier after temozolomide chemotherapy than after radiotherapy alone
chemoradiotherapy
recurrent malignant glioma progression within 1st 3 months
======================================
[3] – What is Pseudo-Progression Following Treatment for Glioblastoma Multiforme?
——————————————————————
Phenomenon – Psuedo-progression (GBM), Brain Tumour Foundation of Canada
——————————————————————
http://www.braintumour.ca/1649/ask-the-expert-psuedo-progression-gbm
======================================
[4] – 1/2010 – Pseudoprogression following chemoradiotherapy for glioblastoma multiforme
——————————————————————
http://www.ncbi.nlm.nih.gov/pubmed/20169771/
——————————————————————
Can J Neurol Sci. 2010 Jan;37(1):36-42
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/20169771/
======================================
[5] – 11/17/2013 – Critiquing: Stanislaw Burzynski in USA Today: Abuse of clinical trials and patients versus the ineffectiveness of the FDA and Texas Medical Board (Getting Worse is Getting Better):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/17/httpscienceblogs-cominsolence20131115stanislaw-burzynski-in-usa-today-abuse-of-clinical-trials-and-patients-versus-the-ineffectiveness-of-the-fda-and-texas-medical-board/
======================================

Dr. David H. “Orac” Gorski http://sciencebasedmedicine versus Personalized Treatment at Burzynski Clinic

Posted on September 5, 2013 by didymusjudasthomas

The above chart is used for ease of reading since it is similar to the one used by Gorski in his article. The below relates to Gorski’s chart

Data as of July 17, 2011 based on medical records of the first 1770 evaluable patients
——————————————————————
The table shows response rates for 22 selected common cancer types treated at the Burzynski Clinic (by highest rate of OR – Objective Response)
——————————————————————
DEFINITIONS:
——————————————————————
OR – Objective Response includes CR, PR, MR & IM
——————————————————————
CR – Complete Response. Complete disappearance of all signs of cancer in response to treatment of 4 weeks or longer
——————————————————————
PR – Partial Response. More than 50% decrease in the size of the tumors (the sum of cross-sectioned area of the tumor) in response to treatment of 4 weeks or longer
——————————————————————
MR – Minor Response. Significant decrease (more than 25% in the size of tumors with simultaneous increase in size of some of the other tumors
——————————————————————
IM – Improvement. Decrease in size of the tumors, not confirmed yet by the second follow-up radiological measurement
——————————————————————
SD – Stable Disease
——————————————————————
PD – Progressive Disease
======================================
[1] – 12/12/2012 – Gorski posted: Stanislaw Burzynski: A pioneering cancer researcher or a quack?

“What I found interesting is a table that posted from the brochure”

“Looking at the table, I noticed immediately that Dr. Burzynski says nothing about survival rates, only “objective response rates,” which are not defined in a meaningful way”
——————————————————————
Gorski, what do you NOT understand about:

Objective Response (OR) includes:

Complete Response (CR)
Partial Response (PR)
Minor Response (MR)
Improvement (IM)
——————————————————————
[1] – 12/12/2012 – “The pamphlet defines them as as anything from an “improvement” (defined as “decrease in size of the tumors, not confirmed yet by the second follow-up radiological measurement”) to “complete disappearance of all signs of cancer,” which is utter bollocks”

“There are standardized ways of measuring tumor response agreed upon by radiologists and oncologists, such as the RECIST criteria”

“Burzynski lumps all responses together in an oncologically meaningless way”
——————————————————————
Gorski, when I did a search in PubMed on this data, why did I get these results ?

6,421-“Objective Response” (2013+prior)
570-phase I:”Objective Response” (2013+)
2,453-phase II:”Objective Response” (2013+)
618-phase III:”Objective Response” (2013+)
19,385-“Complete Response” (2013+prior)
1,182-phase I:”Complete Response” (2013+)
3,851-phase II:”Complete Response” (2013+)
811-phase III:”Complete Response” (2013+)
15,718-“Partial Response” (2013+prior)
1,688-phase I:”Partial Response” (2013+)
4,421-phase II:”Partial Response” (2013+)
497-phase III:”Partial Response” (2013+)
969-“Minor Response” (2013+prior)
155-phase I:”Minor Response” (2013+prior)
314-phase II:”Minor Response” (2013+prior)
12-phase III:”Minor Response” (2009+prior)
10,617-“Stable Disease” (2012+prior)
1,890-phase I:”Stable Disease” (2013+prior)
4,114-phase II:”Stable Disease” (2013+prior)
379-phase III:”Stable Disease” (2013+prior)
11,616-“Progressive Disease” (2013+prior)
615-phase I:”Progressive Disease” (2013+)
1,941-phase II:”Progressive Disease” (2013+)
261-phase III:”Progressive Disease” (2013+)
361,181-Improvement (2013+prior)
1,372-phase I:Improvement (2013+prior)
2,838-phase II:Improvement (2013+prior)
2,293-phase III:Improvement (2013+prior)
1,593-RECIST:(2013+prior)
165-phase I:RECIST:(2013+prior)
475-phase II:RECIST:(2013+prior)
87-phase III: RECIST:(2013+prior)
======================================
And these results ?
——————————————————————
[34] – 5/2007 – “Objective Response” (OR)
Guidance for Industry
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
——————————————————————
[35] – 5-6/2008 – “Complete Response” (CR)
Translating Cancer Trial Endpoints Into the Language of Managed Care

National Cancer Institute (NCI) defines Complete Response (CR) as the “disappearance of all signs of cancer in response to treatment.”
——————————————————————
[36] – 12/1998 – “Partial Response” (PR)
Response Evaluation Criteria in Solid Tumors (RECIST) Quick Reference:

At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD
——————————————————————
[37] – 1/20/2006 – “Minor Response” (MR)
FDA/AACR/ASCO
Public Workshop on Brain Tumor Clinical Trial Endpoints
——————————————————————
[38] – 5/2007 – “Stable Disease” (SD)
Response Evaluation Criteria in Solid Tumors (RECIST) Quick Reference:

Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum LD since the treatment started
——————————————————————
[39] – 4/2008 – “Progressive Disease” (PD)
Response Evaluation Criteria in Solid Tumors (RECIST) Quick Reference:

At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
======================================
REFERENCES:
======================================
[1] – 12/12/2012 – Stanislaw Burzynski: A pioneering cancer researcher or a quack?
——————————————————————
http://scienceblogs.com/insolence/2012/12/12/stanislaw-burzynski-a-pioneering-cancer-researcher-or-a-quack/
======================================
[2] – 6,421 – “Objective Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Objective+Response%22
======================================
[3] – 570 – phase I: “Objective Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Objective+Response%22+%22Phase+I%22
======================================
[4] – 2,453 – phase II: “Objective Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Objective+Response%22+%22Phase+II%29
======================================
[5] – 618 – phase III: “Objective Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Objective+Response%22+%22phase+III%22
======================================
[6] – 19,385 – “Complete Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Complete+Response%22
======================================
[7] – 1,182 – phase I: “Complete Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Complete+Response%22+%22phase+I%22
======================================
[8] – 3,851 – phase II: “Complete Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Complete+Response%22+%22phase+II%22
======================================
[9] – 811 – phase III: “Complete Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Complete+Response%22+%22phase+III%22
======================================
[10] – 15,718 – “Partial Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Partial+Response%22
======================================
[11] – 1688 – phase I: “Partial Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Partial+Response%22+%22phase+I%22
======================================
[12] – 4,421 – phase II: “Partial Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Partial+Response%22+%22phase+II%22
======================================
[13] – 497 – phase III: “Partial Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Partial+Response%22+%22phase+III%22
======================================
[14] – 969 – “Minor Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Minor+Response%22
======================================
[15] – 155 – phase I: “Minor Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Minor+Response%22+%22phase+I%22
======================================
[16] – 314 – phase II: “Minor Response” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Minor+Response%22+%22phase+II%22
======================================
[17] – 12 – phase III: “Minor Response” (2009+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Minor+Response%22+%22phase+III%22
======================================
[18] – 10,617 – “Stable Disease” (2012+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Stable+Disease%22
======================================
[19] – 1890 – phase I: “Stable Disease” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Stable+Disease%22+%22phase+I%22
======================================
[20] – 4,114 – phase II: “Stable Disease” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Stable+Disease%22+%22phase+II%22
======================================
[21] – 379 – phase III: “Stable Disease” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Stable+Disease%22+%22phase+III%22
======================================
[22] – 11,616 – “Progressive Disease” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Progressive+Disease%22
======================================
[23] – 615 – phase I: “Progressive Disease” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Progressive+Disease%22+%22phase+I%22
======================================
[24] – 1,941 – phase II: “Progressive Disease” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Progressive+Disease%22+%22phase+II%22
======================================
[25] – 261 – phase III: “Progressive Disease” (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=%22Progressive+Disease%22+%22phase+III%22
======================================
[26] – 361,181 – Improvement (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=Improvement
======================================
[27] – 1372 – phase I: Improvement (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=Improvement+%22phase+I%22
======================================
[28] – 2,838 – phase II: Improvement (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=Improvement+%22phase+II%22
======================================
[29] – 2,293 – phase III: Improvement (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=Improvement+%22phase+III%22
======================================
[30] – 1,593 – RECIST (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=RECIST
======================================
[31] – 165 – phase I: RECIST (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=RECIST+%22phase+I%22
======================================
[32] – 475 – phase II: RECIST (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=RECIST+%22phase+II%22
======================================
[33] – 87 – phase III: RECIST (2013+prior)
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/?&term=RECIST+%22phase+III%22
======================================
[34] – 5/2007 – “Objective Response” (OR)
Guidance for Industry
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
——————————————————————

Click to access ucm071590.pdf

——————————————————————
http://www.fda.gov/ohrms/dockets/ac/01/slides/3782s1_02_matrix/sld025.htm
======================================
[35] – 5-6/2008 – “Complete Response” (CR)
Translating Cancer Trial Endpoints Into the Language of Managed Care
——————————————————————
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2651701/
Biotechnol Healthc. 2008 May-Jun; 5(1): 22–35.
PMCID: PMC2651701
======================================
[36] – 12/1998 – “Partial Response” (PR)
Response Evaluation Criteria in Solid Tumors (RECIST) Quick Reference:
——————————————————————
http://ctep.cancer.gov/protocolDevelopment/docs/quickrcst.doc
======================================
[37] – 1/20/2006 – “Minor Response” (MR)
FDA/AACR/ASCO
Public Workshop on Brain Tumor Clinical Trial Endpoints
——————————————————————

Click to access ucm120811.pdf

======================================
[38] – 5/2007 – “Stable Disease” (SD)
Response Evaluation Criteria in Solid Tumors (RECIST) Quick Reference:
——————————————————————
http://ctep.cancer.gov/protocolDevelopment/docs/quickrcst.doc
======================================
[39] – 4/2008 – “Progressive Disease” (PD)
Response Evaluation Criteria in Solid Tumors (RECIST) Quick Reference:
——————————————————————
http://ctep.cancer.gov/protocolDevelopment/docs/quickrcst.doc
======================================

Posted in critique, critiques, critiqued, critiquing, Gorski ScienceBlogs.com/Insolence ScienceBasedMedicine, research | Tagged "Barbara Kamanos Cancer Center", "Barbara Kamanos Cancer Institute, "Biotechnol Healthc. 2008 May-Jun; 5(1): 22–35. PMCID: PMC2651701", "Center for Drug Evaluation and Research U.S. Food and Drug Administration Rockville Maryland USA", "doi: 10.1634/theoncologist.13-S2-19 The Oncologist April 2008 vol. 13 Supplement 2 19-21", "Endpoints for Assessing Drug Activity in Clinical Trials", "FDA/AACR/ASCO Public Workshop on Brain Tumor Clinical Trial Endpoints", "Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics", "Guidance for Industry FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products", "minor response", "Oncologist. 2008;13 Suppl .2:19-21. doi: 10.1634/theoncologist.13-S2-19", "Stanislaw Burzynski: A pioneering cancer researcher or a quack?", "Translating Cancer Trial Endpoints Into the Language of Managed Care", "Wayne State University School of Medicine", "Wayne State University", #sciencebasedmedicine, (IM), (MR), (OR), @gorskon, @oracknows, @ScienceBasedMed, Burzynski Clinic, Complete Response, CR, Critiquing Dr. David H. Orac Gorski http://www.sciencebasedmedicine.org, http://cancerbiologyprogram.med.wayne.edu/faculty/gorski.php, http://en.wikipedia.org/wiki/David_Gorski, http://m.theoncologist.alphamedpress.org/content/13/suppl_2/19.abstract, http://m.theoncologist.alphamedpress.org/content/13/suppl_2/19.long, http://prognosis.med.wayne.edu/article/dr-gorski-named-codirector-of-michigan-breast-oncology-quality-initiative, http://sciencebasedmedicine.org, http://scienceblogs.com/Insolence, http://scienceblogs.com/insolence/2012/12/12/stanislaw-burzynski-a-pioneering-cancer-researcher-or-a-quack/, https://stanislawrajmundburzynski.files.wordpress.com, http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ucm120811.pdf, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071657.pdf, http://www.fda.gov/ohrms/dockets/ac/01/slides/3782s1_02_matrix/sld025.htm, http://www.ncbi.nlm.nih.gov/m/pubmed/, http://www.ncbi.nlm.nih.gov/m/pubmed/18434634/, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2651701/, http://www.ncbi.nlm.nih.gov/pubmed/, http://www.ncbi.nlm.nih.gov/pubmed/18434634/, http://www.scienceblogs.com/Insolence, http://www.wsusurgery.com/facultyc3/david-gorski/, http://www.wsusurgery.com/research-team-dr-gorski/, https://mobile.twitter.com/gorskon, https://mobile.twitter.com/oracknows, https://mobile.twitter.com/ScienceBasedMed, Improvement, Objective Response, oncologically, oncologists, Partial Response, PR, Progressive Disease, PubMed, radiological, radiologists, RECIST, src=https://stanislawrajmundburzynski.files.wordpress.com/2013/09/20130904-221632.jpg", stable Disease | Leave a reply

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Critiquing: Stanislaw Burzynski in USA Today: Abuse of clinical trials and patients versus the ineffectiveness of the FDA and Texas Medical Board (swell inflammation phenomenon)

Dr. David H. “Orac” Gorski http://sciencebasedmedicine versus Personalized Treatment at Burzynski Clinic