WHAT IS MISDIRECTION? Critiquing “Antineoplastons: Has the FDA kept its promise to the American people ?”

March 29, 1996

Then United States Food and Drug Administration Commissioner, David 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 trialsfewer 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 informationup front

4. we’re going to require further study AFTERapproval … 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
——————————————————————
BOTTOM LINE:
——————————————————————
Everything else is MISDIRECTION
——————————————————————
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”?
======================================
2003 – 2009 Phase II preliminary
——————————————————————
2003 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs R D. 2003;4(2):91-101
(Drugs in R and D / Drugs in Research and Development)

2003: Protocol – recurrent diffuse intrinsic brain stem glioma

12 – Patients Accrued
10 – Evaluable Patients

2 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
3 / 30% – # and % of Patients Showing Stable Disease
2 / 20% – # and % of Patients Showing Progressive Disease
======================================
http://www.burzynskiclinic.com/scientific-publications.html
Interim Reports on Clinial Trials:

1. 10/2003

NEURO-ONCOLOGY

Burzynski, S.R., Weaver, R.A., Bestak, M., Lewy, R.I., Janicki, T.J., Jurida, G.F., Paszkowiak, J.K., Szymkowski, B.G., Khan, M.I.

Phase II study of Antineoplastons A10 and AS2-1 (ANP) in children with recurrent and progressive MULTICENTRIC GLIOMA

A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/970.pdf
Neuro-Oncology. 2003; 5: 358
Volume 5 Issue 4 October 2003

10/2003 – Protocol – MULTICENTRIC GLIOMA

12 – Children Patients Accrued
10 – Evaluable Patients
(9 months-17 years / 9 – median age)

4 / 33% – # and % of Patients Showing Complete Response
2 / 25% – # and % of Patients Showing Partial Response
4 / 33% – # and % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease
1 / 9% – # and % of Patients Nonevaluable due to only 4 weeks of treatment / lack of follow-up scans
======================================
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
http://www.burzynskiclinic.com/images/stories/Publications/960.pdf

Pgs. 91-92 and 95

3/1996 – Protocol – recurrent diffuse intrinsic BRAIN STEM GLIOMA (3/1996 – 5/1999 enrolled / Pg. 94)

12 – Patients Accrued (6 males / 6 females)
(4-29 years / 10 – median age)
10 – Evaluable Patients

2 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
3 / 30% – # and % of Patients Showing Stable Disease
2 / 20% – # and % of Patients Showing Progressive Disease
======================================
2004 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
Drugs R D. 2004;5(6):315-26
(Drugs in R and D / Drugs in Research and Development)

2004: Protocol – incurable recurrent and progressive multicentric glioma

12 – Patients Accrued
(9 – median age)
11 – Evaluable Patients

4 / 33% – # and % of Patients Showing Complete Response
3 / 25% – # and % of Patients Showing Partial Response
4 / 33% – # and % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease
======================================
Interim Reports on Clinial Trials:

2. 10/2004

NEURO-ONCOLOGY

BT-20
Patients With GLIOBLASTOMA MULTIFORME (GBM)

Weaver, R.A., Burzynski, S.R., Bestak, M., Lewy, R.I., Janicki, T.J., Szymkowski, B., Jurida, G., Khan, M.I., Dolgopolov, V.

Phase II study of Antineoplastons A10 and AS2-1 (ANP) in recurrent GLIOBLASTOMA MULTIFORME
http://www.burzynskiclinic.com/images/stories/Publications/1218.pdf
Neuro-Oncology. 2004; 6: 384
Volume 6 Issue 4 October 2004
Abstracts from the Society for Neuro-Oncology Ninth Annual Meeting, Toronto, Ontario, Canada, November 18-21, 2004

Pg. 385

10/2004 – Protocol – glioblastoma multiforme (GBM) which recurred or progressed post surgery, radiation therapy, and / or chemotherapy

22 – Evaluable Patients
(6 men / 16 women / 27-63 /47 – median age)

1 / 4.5% – # and % of Patients Showing Complete Response
1 / 4.5% – # and % of Patients Showing Partial Response
12 / 54.5% – # and % of Patients Showing Stable Disease
8 / 36.5% – # and % of Patients Showing Progressive Disease
======================================
Interim Reports on Clinial Trials:

3. 10/2004 (DBSG)

NEURO-ONCOLOGY

Burzynski, S.R., Weaver, R. Bestak. M., Lewy, R.I., Janicki, T., Jurida, G., Szymkowski, B., Khan, M., Dolgopolov, V.

Long-term survivals in phase II studies of Antineoplastons A10 and AS2-1 (ANP) in patients with diffuse intrinsic BRAIN STEM GLIOMA
http://www.burzynskiclinic.com/images/stories/Publications/1219.pdf
Neuro-Oncology. 2004; 6: 386
Volume 6 Issue 4 October 2004

60 patients
(31 didn’t meet admission criteria to the study and were treated under Special Exception (SE))

10/2004 – Protocol – patients with diffuse intrinsic BRAIN STEM GLIOMA (DBSG)

29 – Evaluable Patients

7 / 24% – # and % of Patients Showing Complete Response
6 / 21% – # and % of Patients Showing Partial Response
6 / 21% – # and % of Patients Showing Stable Disease
10 / 34% – # and % of Patients Showing Progressive Disease
——————————————————————
31 – Evaluable Patients: Special exception (SE)

5 / 16% – # and % of Patients Showing Complete Response
2 / 6% – # and % of Patients Showing Partial Response
16 / 52% – # and % of Patients Showing Stable Disease
8 / 26% – # and % of Patients Showing Progressive Disease
======================================
Interim Reports on Clinial Trials:

4. 10/2004 (AT/RT of CNS)

NEURO-ONCOLOGY

BT-14

CHILDREN WITH RHABDOID TUMOR OF THE CENTRAL NERVOUS SYSTEM

Burzynski, S.R., Weaver, R. Bestak. M., Janicki, T., Jurida, G., Szymkowski, B., Khan, M., Dolgopolov, V.

Phase II studies of antineoplastons A10 and AS2-1 (ANP) in children with atypical teratoid/rhabdoid tumors (AT/RT) of the central nervous system

A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/1146.pdf
Neuro-Oncology. 2004; 6: 427
Volume 6 Issue 4 October 2004
Abstracts from the Eleventh International Symposium on Pediatric Neuro-Oncology, Boston, Massachusetts, June 13-16, 2004

10/2004 – Protocol – children with atypical teratoid / rhabdoid tumors (AT / RT) of the central nervous system

11 – Children Patients Accrued
8 – Evaluable Patients
(7 treated under Special Exception (SE))

2 / 25% – # and % of Patients Showing Complete Response
1 / 12.5% – # and % of Patients Showing Partial Response
1 / 12.5% – # and % of Patients Showing Stable Disease
4 / 50% – # and % of Patients Showing Progressive Disease
======================================
Interim Reports on Clinial Trials:

5. 10/2004

NEURO-ONCOLOGY

BT-12

CHILDREN WITH PRIMITIVE NEUROECTODERMAL TUMORS (PNET)

Burzynski, S.R., Weaver, R. Bestak. M., Janicki, T., Szymkowski, B., Jurida, G., Khan, M., Dolgopolov, V.

Treatment of PRIMITIVE NEUROECTODERMAL TUMORS (PNET) with antineoplastons A10 and AS2-1 (ANP)

Preliminary results of phase II studies
http://www.burzynskiclinic.com/images/stories/Publications/1147.pdf
Neuro-Oncology. 2004; 6: 428
Volume 6 Issue 4 October 2004
Abstracts from the Eleventh International Symposium on Pediatric Neuro-Oncology

10/2004 – Protocol – PRIMITIVE NEUROECTODERMAL TUMORS (PNET)

17 – Patients Accrued
15 – Evaluable Patients
(12 months – 23 years / 6 – median age)

3 / 20% – # and % of Patients Showing Complete Response
2 / 13.4% – # and % of Patients Showing Partial Response
5 / 33.3% – # and % of Patients Showing Stable Disease
5 / 33.3% – # and % of Patients Showing Progressive Disease
======================================
Interim Reports on Clinial Trials:

17. 2004

DRUGS IN R&D
Drugs in R and D
(Drugs in Research and Development)

Burzynski, S.R., Weaver, R., Lewy, R., Janicki, T. Jurida, G., Szymkowski, B., Khan, M., Bestak, M.

Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma.

A Preliminary Report.
http://www.ncbi.nlm.nih.gov/pubmed/15563234
Drugs R&D 2004;5(6):315-326.
http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
Drugs R D. 2004;5(6):315-26
http://www.burzynskiclinic.com/images/stories/Publications/1194.pdf

incurable recurrent and progressive multicentric glioma

Pg. 320

3 – treated under Special Exception (SE) granted by the US FDA

Pgs. 317 and 320

7/31/1996 – (7/31/1996 – 4/3/2002 as of 3/1/2004) Protocol – children with recurrent and progressive multicentric glioma (MCG)

Pg. 317

BT-13

children with low-grade astrocytoma

BT-23

children with visual pathway gliomas


Pgs. 317 and 320-321

12 – Children Patients Accrued (Pgs. 315-316)
(9 months – 17 years / 9- median age)
(6 – male / 6 – females)
10 – Evaluable Patients (Pg. 315)

4 / 33% – # and % of Patients Showing Complete Response
3 / 25% – # and % of Patients Showing Partial Response
4 / 33% – # and % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease
1 / 9% – # and % of Patients Non-evaluable
——————————————————————
Pg. 325

Compare: Chamberlain and Grafe. [38]

1995 – Protocol – solitary recurrent chiasmatic hypothalamic gliomas treated with oral etoposide


14 – Patients Accrued
14 – Evaluable Patients

1 / 7% – # and % of Patients Showing Complete Response
4 / 29% – # and % of Patients Showing Partial Response
3 / 21% – # and % of Patients Showing Stable Disease
6 / 43% – # and % of Patients Showing Progressive Disease

Pg. 326

38. Chamberlain MC, Grafe MR. Recurrent chiasmatic-hypothalamic glioma treated with oral etoposide. J Clin Oncol 1995; 13: 2072-6
http://www.ncbi.nlm.nih.gov/pubmed/7636550/
J Clin Oncol. 1995 Aug;13(8):2072-6.
http://www.ncbi.nlm.nih.gov/m/pubmed/7636550/
Department of Neurosciences, University of California, San Diego, La Jolla, USA.
http://m.jco.ascopubs.org/content/13/8/2072.long
Arch Neurol. 1995 May;52(5):509-13.
http://www.ncbi.nlm.nih.gov/pubmed/7733847/
Department of Neurosciences, University of California-San Diego, USA.
http://www.ncbi.nlm.nih.gov/m/pubmed/7733847/
Arch Neurol. 1995;52(5):509-513. doi:10.1001/archneur.1995.00540290099024.
http://archneur.jamanetwork.com/Mobile/article.aspx?articleid=593460
——————————————————————
Compare: The Pediatric Oncology Group. [39]

10/2000 – Protocol – solitary progressive optic pathway tumors with carboplatin

50 – Patients Accrued
50 – Evaluable Patients

2 / 4% – # and % of Patients Showing Partial Response
37 / 74% – # and % of Patients Showing Stable Disease
11 / 22% – # and % of Patients Showing Progressive Disease

39. Mahoney DH, Cohen ME, Friedman HS, et al. Carboplatin is effective therapy for young children with progressive optic pathway tumors: a Pediatric Oncology Group phase II study. Neuro-oncol 2000; 2: 213-20
http://www.ncbi.nlm.nih.gov/pubmed/11265230/
Neuro Oncol. 2000 Oct;2(4):213-20.
http://www.ncbi.nlm.nih.gov/m/pubmed/11265230/
Baylor College of Medicine, Houston, TX, USA.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1920597/

http://neuro-oncology.oxfordjournals.org/content/2/4/213.full.pdf
======================================
2005 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
Integr Cancer Ther. 2005 Jun;4(2):168-77
(Integrative Cancer Therapies)

2005: Protocol – recurrent disease or high risk

13 – Patients Accrued
(1-11 – age / 5 years 11 months – median age)
13 – Evaluable Patients

3 / 23% – # and % of Patients Showing Complete Response
1 / 8% – # and % of Patients Showing Partial Response
4 / 31% – # and % of Patients Showing Stable Disease
5 / 38% – # and % of Patients Showing Progressive Disease
——————————————————————
(Updated 2007)
http://www.cancer-therapy.org/CT/v5/B/HTML/42._Burzynski,_379-390.html
2005 – Protocol – incurable recurrent and progressive multicentric glioma

13 – Patients Accrued

3 / 23% – # and % of Patients Showing Complete Response
1 / 8% – # and % of Patients Showing Partial Response
4 / 31% – # and % of Patients Showing Stable Disease
5 / 38% – # and % of Patients Showing Progressive Disease
======================================
2006 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
Integr Cancer Ther. 2006 Mar;5(1):40-7
(Integrative Cancer Therapies)

2006: Protocol – high-grade pathology (HBSG)

– Patients Accrued
18 – Evaluable Patients

2 / 11% – # and % of Patients Showing Complete Response
2 / 11% – # and % of Patients Showing Partial Response
7 / 39% – # and % of Patients Showing Stable Disease
7 / 39% – # and % of Patients Showing Progressive Disease
======================================
Interim Reports on Clinial Trials:

BT-03


BT-11

BRAIN STEM GLIOMA (BSG)

BT-18

6. MIXED GLIOMA

ADULT PATIENTS WITH MIXED GLIOMA

“mixed glioma”, a type of primary malignant brain tumor (PMBT)

BT-22

8. CHILDREN WITH PRIMARY MALIGNANT BRAIN TUMORS

CAN-01 (CAN-1)

PATIENTS WITH REFRACTORY MALIGNANCIES

19. 3/2006

Burzynski, S.R., Janicki, T.J., Weaver, R.A., Burzynski, B. Targeted therapy with Antineoplastons A10 and AS2-1 of high grade, recurrent, and progressive BRAINSTEM GLIOMA. Integrative Cancer Therapies 2006;5(1):40-47
http://www.ncbi.nlm.nih.gov/pubmed/16484713
Integr Cancer Ther. 2006 Mar;5(1):40-7
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
DOI: 10.1177/1534735405285380
http://www.burzynskiclinic.com/images/stories/Publications/5825.pdf

http://m.ict.sagepub.com/content/5/1/40.long?view=long&pmid=16484713
Pgs. 40-41

4 phase 2 trials

BRAINSTEM GLIOMA (BSG)

patients with inoperable tumor of high-grade pathology (HBSG)
glioblastoma

recurrent diffuse intrinsic glioblastomas and ANAPLASTIC ASTROCYTOMAs of brainstem

Pg. 43

BT-03 – 1 / female
BT-11 – 13 (8 males/5 females)
BT-18 – 1 / female
BT-22 – 2 / females
CAN-01 – 1 / female

Pg. 44

High-grade, recurrent, and progressive brainstem gliomas

Pgs. 40-42 and 44-45

7/12/1988 (7/12/1988 – 11/13/2003 as of 6/10/2005) – Protocol – recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem high-grade pathology (HBSG)

18 – Evaluable Patients (Pgs. 40-43)
(8 males / 10 females / 2-42 / 10 – median age / Pgs. 42-43)

2 / 11% – # and % of Patients Showing Complete Response
2 / 11% – # and % of Patients Showing Partial Response
7 / 39% – # and % of Patients Showing Stable Disease
7 / 39% – # and % of Patients Showing Progressive Disease
======================================
Interim Reports on Clinial Trials:

BT-11

BRAIN STEM GLIOMA

8. 10/2006

Burzynski, S.R., Janicki, T.J., Weaver, R.A., Szymkowski, B.G., Khan, M.I., Dolgopolov, V. Treatment of multicentric BRAINSTEM GLIOMAs with antineoplastons (ANP) A10 and AS2-1. Neuro-Oncology. 2006; 8:466.
http://www.burzynskiclinic.com/images/stories/Publications/2105.pdf
Volume 8 Issue 4 October 2006
Abstracts for the Eleventh Annual Meeting of the Society for Neuro-Oncology (SNO)

Brainstem gliomas and multicentric tumors (MBSG)

10/2006 – Protocol – Brainstem gliomas and multicentric tumors (MBSG)

19 – Evaluable Patients
3.9 – 40.8 years (9.2 – median age)
(90% less than 18 years old)

2 / 11% – # and % of Patients Showing Complete Response
1 / 5% – # and % of Patients Showing Partial Response
7 / 37% – # and % of Patients Showing Stable Disease
9 / 47% – # and % of Patients Showing Progressive Disease
======================================
2007
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf
2004 – Protocol – small group of patients with progressive LGA, ANP
60% – % of Patients Showing Complete Response
10% – % of Patients Showing Partial Response
——————————————————————
2004 – Protocol – low-grade astrocytoma in children
Burzynski [39] – Reference
Phase II d – d = Preliminary results – Study type
P – P = progressive tumor – Tumor type
(no. of pts) – pts = patients
ANP (10) – ANP = antineoplastons A10 and AS2-1 – Treatment
10 – Evaluable Patients {(78) = most in a study}
OS [%] – OS = overall survival
100% (1 yr) – 90% (3 yr) – Efficacy
93 mo – MST = MST = median survival time – {96 (1 y) next closest}
60% (6) – % and # of Patients Showing Complete Response {24 (11) next closest}
10% (1) – % and # of Patients Showing Partial Response {60% (9) best other study}
30% (3) – % and # of Patients Showing Stable Disease + MR = minor response {70% (14) best other study}
0% (0) – % and # of Patients Showing Progressive Disease {4% (2) next closest}
PFS (%)
90 (1 y) – 90 (3 y) – PFS = progression-free survival {100 (1 y) – 68 (3 y) best other study
——————————————————————
2004 – Protocol – diffuse, intrinsic brainstem glioma in children
Burzynski et al. [88] – Reference
Phase II – Study Type
(no. of pts) – pts = patients
RP (30) – RP = recurrent and progressive tumor – Tumor type
30 – Evaluable Patients
ANP – ANP = antineoplastons A10 and AS2-1 – Treatment – ANP
OS (%) – OS = overall survival
[2y; 5y]
46.7; 30 – Efficacy
MST (mo)
19.9 – MST = median survival time
27% (8) – % and # of Patients Showing Complete Response
20% (6) – % and # of Patients Showing Partial Response
23% (7) – % and # of Patients Showing Stable Disease
30% (9) – % and # of Patients Showing Progressive Disease
——————————————————————
Burzynski et al. [89] – Reference
Phase II – Study Type
(no. of pts) – pts = patients
RPS (10) – RPS = recurrent and progressive tumors in children aged <4y – Tumor type {(66) = most in a study}
ANP – ANP = antineoplastons A10 and AS2-1 – Treatment – ANP
OS (%) – OS = overall survival
[2y; 5y] – Efficacy
60; 20 {46.7 (30) = next best study}
MST (mo)
26.3 – MST = median survival time – {19.9 = next best study}
[% (no. )]
30% (3) – CR = complete response – {27% (8) = next best study}
[% (no. )]
0% (0) – PR = partial response – {56% (1) = next best}
[% (no. )]
40% (4) – SD = stable disease – {44% (25) = best}
[% (no. )]
30% (3) – PD = progressive disease – {23% (13) = best}
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Interim Reports on Clinial Trials:

BT-11

BRAIN STEM GLIOMA

9. 4/2007 (NDBSG)

Burzynski, S.R., Weaver, R.A., Janicki, T.J., Jurida, G.F., Szymkowski, B.G., Kubove, E. Phase II studies of Antineoplastons A10 and AS 2-1 (ANP) in children with newly diagnosed diffuse, intrinsic BRAINSTEM GLIOMAs. Neuro-Oncology 2007; 9:206.
http://www.burzynskiclinic.com/images/stories/Publications/4021.pdf
Volume 9 Issue 2 April 2007
Abstracts from the Twelfth International Symposium on Pediatric Neuro-Oncology

4/2007 – Protocol – newly diagnosed diffuse, intrinsic BRAINSTEM GLIOMAs (NDBSG)

20 – Evaluable assessable children Patients
(3 months-20 years – age)

6 / 30% – # and % of Patients Showing Complete Response
2 / 10% – # and % of Patients Showing Partial Response
4 / 20% – # and % of Patients Showing Stable Disease
8 / 40% – # and % of Patients Showing Progressive Disease
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Interim Reports on Clinial Trials:

BT-11

BRAIN STEM GLIOMA

Special exception (SE)

13. 12/2009 (DBSG)

Burzynski, S.R., Janicki, T.J., Weaver, R.A., Szymkowski, B., Burzynski, G.S. Phase II study of antineoplastons A10 and AS2-1 in patients with BRAINSTEM GLIOMA. Protocol BC-BT-11. Neuro-Oncology 2009, 11:951.
http://www.burzynskiclinic.com/images/stories/Publications/8639.pdf
Volume 11 Issue 6 December 2009
Abstracts from the Third Quadrennial Meeting of the World Federation of Neuro-Oncology (WFNO) and the Sixth Meeting of the Asian Society for Neuro-Oncology (ASNO)
May 11-14, 2009
Yokohama, Japan

12/2009 – Protocol – BRAINSTEM GLIOMAs

40 – Patients Accrued
28 – Evaluable Patients
(23 children / 5 young adults)

5 / 18% – # and % of Patients Showing Complete Response
4 / 14% – # and % of Patients Showing Partial Response
12 / 43% – # and % of Patients Showing Stable Disease
7 / 25% – # and % of Patients Showing Progressive Disease
——————————————————————
Special exception (SE)

12/2009 – Protocol – BRAINSTEM GLIOMAs

52 – Evaluable Patients
(40 children / 12 young adults)

5 / 10% – # and % of Patients Showing Complete Response
2 / 4% – # and % of Patients Showing Partial Response
28 / 54% – # and % of Patients Showing Stable Disease
17 / 32% – # and % of Patients Showing Progressive Disease
——————————————————————
BT-11 and special exception (SE)
92% – diffuse intrinsic brainstem gliomas (DBSG)

Overall survival (OS) – 2 years:
42% – special exception (SE)
36% – BT-11

Overall survival (OS) – 5 years:
19% – special exception (SE)
25% – BT-11
======================================
Compare: standard radiation therapy in combination with chemotherapy (RAT) (Mandell et al. 1999)

2% – % of Patients Showing Complete Response
31% – % of Patients Showing Partial Response

Mandell LR, Kadota R, Freeman C, et al. There is no role for hyperfractionated radiotherapy in the management of children with newly diagnosed diffuse intrinsic brain stem tumors: results of pediatric oncology group phase III trial comparing conventional vs. hyperfractionated radiotherapy. Int J Radiat Oncol Biol Phys. 1999;43:959-964.
http://www.ncbi.nlm.nih.gov/pubmed/10192340/
Int J Radiat Oncol Biol Phys. 1999 Mar 15;43(5):959-64.
http://www.ncbi.nlm.nih.gov/m/pubmed/10192340/
International Journal of Radiation Oncology*Biology*Physics
Volume 43, Issue 5, 15 March 1999, Pages 959–964
http://www.sciencedirect.com/science/article/pii/S036030169800501X
Department of Radiation Oncology, Mount Sinai Medical Center, New York, NY, USA.
6/1992 – 10/1997

Overall survival (OS):
7% – 2 years
0% – 5 years
=====================================
COMBINED:
——————————————————————
Overall survival (OS) – 2 years:
——————————————————————
42% – antineoplastons: special exception (SE)

36% – antineoplastons: BT-11

7% – standard radiation therapy in combination with chemotherapy (RAT)
——————————————————————
Overall survival (OS) – 5 years:
——————————————————————
25% – antineoplastons: BT-11

19% – antineoplastons: special exception (SE)

0% – standard radiation therapy in combination with chemotherapy (RAT)
� � � � � � � � � � � � � � � � �
Break The Walls Down:

——————————————————————
And “THAT’s The BOTTOM LINE”
Because Stone Cold Said So

——————————————————————
IT’s GO TIME
Time To Play The Game:

——————————————————————
Break The Walls Down:

=====================================

I show JzG what a “FACT” is: Burzynski: FAQ (Frequently Asked Questions): Clinical Trial Results:

Burzynski: FAQ (Frequently Asked Questions): Clinical Trial Results:
redd.it/1e458n
FAQ
http://po.st/SLDlJ
Who is JzG and why should you care?

JzG claims there is a “misleading factoid”

JzG does NOT seem to comprehend that the reason something is titled as a “FACT,” is because it is NOT misleading

JzG does NOT seem to understand that indicating that a “FACT” is misleading, is oxymoronic

It is a “FACT” that:

“Trial results are not always publicly available, even after a clinical trial ends”

(Source: U.S. National Library of Medicine, National Institutes of Health)

An individual with the same initials (JzG also known as JzG|Guy) is one of the “gatekeepers” of the “Burzynski Clinic” Wikipedia page, as I documented HERE:

guychapman (Guy Chapman) Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 9)
redd.it/1dpsj6
(Guy Chapman, @SceptiGuy, @vGuyUK, guychapman)

http://redd.it/1dpsj6
Wikipedia apologist Guy Chapman’s United Kingdom “blahg:”
http://www.chapmancentral.co.uk/blahg
Wikipedia, what’s your motivation?:
redd.it/1dk974
WP
http://t.co/N7ErbunCV2
JzG are you related to Guy Chapman?

I consider him to be a coward

Wikipedia’s “Neutral” policy history clearly indicates:

“The relative prominence of each viewpoint among Wikipedia editors or the general public is not relevant and should not be considered, …”

[[WP:NPOV]] “History of NPOV:” (Content # 6, Note 3)

(Wikipedia: Neutral Point Of View)

This is also a “factoid,” and the JzG|Guy “gatekeeper” on Wikipedia gave it the same amount of respect JzG gives the U.S. National Library of Medicine, National Institutes of Health

Which leads one to wonder if they are twins, considering that one had the testicular fortitude to post a comment, and the other is a coward and trumpets U.K. views

One JzG|Guy commented on Wikipedia:

> “We are told that 2013 will be a big year, but apparently his plan is to

> release another bullshit movie not to publish useful research.” JzG|Guy
> User:JzG/help|Help! 21:52, 24 December 2013
>
See
http://en.wikipedia.org/w/index.php?title=User_talk:Didymus_Judas_Thomas&diff=next&oldid=528610760
to view this change

and:
>
> “There is unlikely to be any dispassionate debate over ANPs while Burzynski
> continues with his unethical practices.” JzG|Guy User:JzG/help|Help!
> 12:43, 26 December 2012
>
> Continues with his unethical practices.? Yet TMB/SOAH had their
> case dismissed? Is WP judge, jury, & executioner?

>
See
http://en.wikipedia.org/w/index.php?title=Talk:Burzynski_Clinic&diff=next&oldid=529537854
to view this change.

I could really care less what JzG|Guy’s “opinion” is, since:

Wikipedia’s “Neutral” policy history clearly indicates:

“The relative prominence of each viewpoint among Wikipedia editors or the general public is not relevant and should not be considered, …”

[[WP:NPOV]] “History of NPOV:” (Content # 6, Note 3)

(Wikipedia: Neutral Point Of View)

As the old military saying goes:

If I wanted your opinion … (Wikipedia) … I’d beat it out of you

In this blog post reply, Wikipedia shill “JzG” presents a single myopic misleading meme for a number of reasons in respect of Stanislaw Burzynski

JzG posits:

“Most obvious of these is that of the 61 trials registered by Burzynski over nearly two decades, only one has even been completed.”

WHAT “completed” trial is JzG referring to?

Good question, since I have yet to find one of “The Skeptics” who could adequately describe what Protocol, start date, and completion date apply to this “one” trial they keep mentioning

Antineoplaston Therapy in Treating Patients With Stage IV Melanoma
Phase II
Status: COMPLETED
Age: 18 and over
Protocol IDs: CDR0000066552, BC-ME-2, NCT00003509

11/25/1997 – FORM 10-SB
http://pdf.secdatabase.com/2573/0000950110-97-001598.pdf
ME-2 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN PATIENTS WITH MALIGNANT MELANOMA
8 40
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised

11/1/1999 – First received

5/23/2009 – Last updated

5/2009 – Last verified
http://clinicaltrials.gov/ct2/archive/NCT00003509
Burzynski Clinical Trials (The SEC filings):
redd.it/1e2f2i
5/1/2012 Certain prospective protocols which have reached a Milestone:
http://redd.it/1e2f2i
Antineoplaston Therapy in Treating Patients With Stage IV Melanomau
Melanoma (Skin)
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
COMPLETED
Age 18 and over
Protocol IDs
CDR0000066552
BC-ME-2, NCT00003509

http://cancer.gov/clinicaltrials/BC-ME-2
2009_05_26 Study Changes Recruitment status, Recruitment, Misc.
1 clinical_study study_id
2
is_fda_regulated Yes
is_section_801 Yes
delayed_posting No
resp_party name_title Stanislaw R. Burzynski
name_title organization Burzynski Clinic
organization resp_party

Fm: Active, not recruiting
To: COMPLETED

status date
Fm: 2008-04
To: 2009-05

date
Fm: 2008-01
To: 2005-02

last_release_date
Fm: 2008-07-23
To: 2009-05-23

http://clinicaltrials.gov/archive/NCT00003509/2009_05_26/changes
“COMPLETED:”

2009-05-23 (5/23/2009)

To put this in perspective, the below study done in 2006, was NOT published until about 7 years later, in 2013

2/13/2013 – The frequency, cost, and clinical outcomes of HYPERNATREMIA in patients hospitalized to a comprehensive CANCER center
http://www.ncbi.nlm.nih.gov/m/pubmed/23404230
Over 3 month period in 2006 re 3,446 patients, most of the HYPERNATREMIA (90 %) was acquired during hospital stay

Division of Internal Medicine, UT MD Anderson Cancer Center, Houston, TX, USA

Department of General Internal Medicine, University of Texas MD Anderson Cancer Center

Division of Endocrinology, Mayo Clinic

Support Care Cancer. 2013 Feb 13. [Epub ahead of print]

Supportive Care in Cancer
February 2013

DOI
10.1007/s00520-013-1734-6

http://link.springer.com/article/10.1007%2Fs00520-013-1734-6

JzG continues:

“Then there’s the fact that unpublished trials are not generally acceptable when applying for approval for a drug, or when promoting the drug (in this case it’s hardly relevant as he appears to have no intention of applying for approval; the trials seem to be used as an end-run around restrictions on his use of unapproved drugs).”

JzG ignores:

Burzynski: What happens when a clinical trial is over?:

National Cancer Institute (NCI) at the National Institutes of Health (NIH)

Cancer Clinical Trials

15. What happens when a clinical trial is over?

“The results of clinical trials are OFTEN published in peer-reviewed scientific journals”

” … WHETHER OR NOT the results are published in a peer-reviewed scientific journal … “
http://m.cancer.gov/topics/factsheets/clinical-trials
This makes it clear that clinical trial results “are OFTEN” published, but sometimes they are “NOT” published “in a peer-reviewed scientific journal”

Burzynski: Declaration of Helsinki:
redd.it/1e4ybx
Helsinki
http://po.st/ajl2Xy
The Declaration of Helsinki does NOT indicate WHEN final (completed) results of human clinical trials MUST be published

Burzynski: The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective:
redd.it/1e6gvj
Nowhere does it indicate that final (completed) human clinical trial results MUST be published in a peer-reviewed scientific medical journal
http://redd.it/1e6gvj
JzG comments:

“Why does the medical and scientific community not accept Burzynski’s claims to cure cancer? Because he has failed to publish credible evidence. The few papers he has published are neither compelling nor generally useful in evaluating his claims.”

JzG where is / are YOUR in-depth review(s) of the 2003-2007 phase II clinical trials preliminary reports?

Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 11)

onforb.es/11pwse9

http://t.co/vh3cgAR6hW

http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics
Didymus Judas Thomas, Contributor

Musings on the intersection of Articles, Bias, and Censorship

(The Big 3: A.B.C.)

4/19/2013 @ 9:43PM

A Film Producer, A Cancer Doctor, And Their Critics

Allen Jones 1 day ago

“Interesting article.”

“Since there are two competing sides here I decided to do a bit of research on Burzynski and his treatment.”

“Success seems to be defined in terms of anecdotes only.”

“And after a continued search there seems to be just as many anecdotes of failures for this treatment.”

“Reading the website “the other Burzynski patient group” that outline all the heart wrenching failures of this treatment was difficult.”

“My conclusion is that this Burzynski is a quack of the lowest level.”

“Shameful!!!”

Allen Jones, I really can NOT adequately express how convincing your “alleged” “bit of research” sounds

Shameful!!!”???

claire G 1 day ago

@Guy Chapman,

(claire G, I really can NOT adequately express how convincing your use of @Guy Chapman is, considering as how “Guy Chapman” has gone by “guychapman” in all 18 of his “erudite” posts)

“It seems to me that actually the FDA are being very fair to Burzynski.”

claire G, please expand on how THIS is “the FDA” “being very fair to Burzynski.”
http://burzynskimovie.com/images/stories/transcript/Documents/BurzynskiTriesToExposeNCI.pdf
“Despite the massive problems with hsi institutional review board, and his abject failure to publish results, they continued to allow him to register new trials.”

claire G, please expand on:

“they continued to allow him to register new trials.”

Exactly WHEN did “they continued to allow him to register new trials” “[d]espite the massive problems with hsi institutional review board”?

Please advise WHERE
“his abject failure to publish results”
was a condition for him “to register new trials.”

“I can’t think of anyone else in that position”.”

“You are so right.”

claire G, “you are so right”

“I can’t think of anyone else in that position”.

Exactly HOW are you going to answer THOSE questions?

“That cracking sound you hear is the FDA bending over backwards to accommodate Burzynski!”

claire G, please explain exactly HOW was the FDA requiring radiation in the phase 3 clinical trial, bending over backwards to accommodate Burzynski!”

Securities and Exchange Commission (SEC) Form 10-Q for the quarterly period ended 5/31/2010:

1/13/2009 Company announced Company had reached an agreement with FDA for Company to move forward with pivotal Phase III clinical trial of combination Antineoplaston therapy plus radiation therapy in patients with newly diagnosed, diffuse, intrinsic brainstem gliomas (DBSG)

Agreement was made under FDA’s Special Protocol Assessment procedure, meaning design and planned analysis of Phase III study is acceptable to support regulatory submission seeking new drug approval

2/1/2010 Company entered into agreement with Cycle Solutions, Inc., dba ResearchPoint to initiate and manage pivotal Phase III clinical trial of combination Antineoplastons A10 and AS2-1 plus radiation therapy (RT) in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma

ResearchPoint is currently conducting feasibility assessment

ResearchPoint has secured interest and commitment from number of sites selected

Upon completion of assessment, randomized, international phase III study will commence”

Study’s objective is to compare overall survival of children with newly-diagnosed DBSG who receive combination Antineoplastons A10 and AS2-1 plus RT versus RT alone

” … only obstacles now are $300 million $s needed to pay for final phase of clinical testing-and FDA requiring children with inoperable brainstem glioma to also undergo radiation
treatment in Phase 3 trials, claiming it would be “unethical” not to do so”

“For all the whining and complaining by Burzynski fans that he’s been so hounded and mistreated by the FDA,”

claire G, please pontificate on THIS:
http://stanislawrajmundburzynski.wiki-site.com/index.php/Main_Page
“I’ve never seen any doctor be allowed that much time and leeway to conduct clinical trials.”

claire G, please advise, what doctor has been allowed the next most “time and leeway to conduct clinical trials,” after Burzynski?

“The big question in many people’s minds is, WHY has Burzynski been given this special treatment?”

claire G, THIS “special treatment?

Antineoplastons: Has the FDA kept its promise to the American people ?:
https://stanislawrajmundburzynski.wordpress.com/2013/03/22/antineoplastons-has-the-fda-kept-its-promise-to-the-american-people
claire G, any questions NOW?

claire G 1 day ago

@AstroturfWatch,

“Antineoplastons are dead.

No more in the USA.

Only the rich, powerful, and the affluent who are “in the know” can get it now (no longer in the USA).”

“Ha!”

“So what you mean then is that nothing has really changed?”

claire G, are you indicating that antineoplastons were NOT available in the USA?

“It was always only either the very wealthy or those who could scrap together the $200,00.00 from donations who could afford antineoplastons.”

claire G, are you indicating that EVERY antineoplaston patient has had to “SCRAP together the $200,00.00”?

“By not publishing his research so that it could be peer reviewed and approved by the FDA Burzynski assured that antineoplastons would not be covered by insurance.”

claire G, please provide your citation(s), reference(s), and / or link(s) which support your:

“By not publishing his research so that it could be peer reviewed and approved by the FDA

Burzynski: What happens when a clinical trial is over?:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-what-happens-when-a-clinical-trial-is-over
National Cancer Institute (NCI) at the National Institutes of Health (NIH)

Cancer Clinical Trials

15. What happens when a clinical trial is over?

“The results of clinical trials are OFTEN published in peer-reviewed scientific journals”

” … WHETHER OR NOT the results are published in a peer-reviewed scientific journal … “
http://m.cancer.gov/topics/factsheets/clinical-trials
This makes it clear that clinical trial results “are OFTEN” published, but sometimes they are “NOT” published “in a peer-reviewed scientific journal”

Burzynski: FAQ: Clinical Trial Results
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-faq-clinical-trial-results/
Trial results are not always publicly available, even after a clinical trial ends

U.S. National Library of Medicine National Institutes of Health
http://www.nlm.nih.gov/services/ctresults.html
Burzynski: The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-the-fdas-drug-review-process-ensuring-drugs-are-safe-and-effective
“The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective”

“[T]he emphasis in Phase 2 is on EFFECTIVENESS”

“This phase aims to obtain PRELIMINARY DATA on whether the drug works in people who have a certain disease or condition”

“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2″

“These studies gather more information about safety and EFFECTIVENESS, studying different populations and different dosages and using the drug in combination with other drugs”
http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm
Burzynski: Declaration of Helsinki:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-declaration-of-helsinki
World Medical Association
http://www.wma.net/en/30publications/10policies/b3
PDF:
http://www.wma.net/en/30publications/10policies/b3/17c.pdf
PDF:
http://www.who.int/bulletin/archives/79(4)373.pdf
National Institutes of Health-HISTORY:
http://history.nih.gov/research/downloads/helsinki.pdf
The Declaration of Helsinki doesn’t indicate WHEN results MUST be published

“If you were sitting on this effective cure for cancers that affect children especially, wouldn’t you want to do whatever it took to make it available to anyone who needed it?”

claire G, ask the FDA

“Isn’t that what an ethical, caring, humanitarian would do?”

claire G, I refer you to the above

Boris Ogon

“You are right now having a live “debate” in front of more than 10,000 people, … “

Peter Lipson, Contributor
Musings on the intersection of science, medicine, and culture

3,932 views

Not so much

Waiting for the 10,000

Peter Lipson, Contributor

Musings on the intersection of science, medicine, and culture

4/19/2013 @ 9:43PM

Peter Lipson: “Speech is best countered by more speech”

Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 10)

onforb.es/11pwse9

http://t.co/vh3cgAR6hW

http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics
Didymus Judas Thomas, Contributor

Musings on the intersection of Articles, Bias, and Censorship

(The Big 3: A.B.C.)

4/19/2013 @ 9:43PM

A Film Producer, A Cancer Doctor, And Their Critics

randy hinton 5 days ago

Hey Petey!

“I am ready to sit on a stage with Eric in front of a large crowd and debate this matter with you ANYTIME YOUR READY.”

Petey!, responds:

guychapman 5 days ago

(citing randy hinton 5 days ago)

“WHY DID 230 CHILDREN’S HOSPITAL’S TURN DOWN BURZYNSKI’S PHASE 3 BRAINSTEM GLIOMA TRIAL???”

“The answer is in your own post.”

“They were not convinced the treatment was likely to provide benefit, so why on earth would they subject children to the side effects, infection risk and other known problems with ANP treatment?”

“Unlike Burzynski, they seem to have followed the dictates of the Helsinki declaration.”

guychapman, HOW has Burzynski NOT “followed the dictates of the Helsinki declaration.”?

YOU remind me of this randy hinton comment:

“The hospital’s don’t seem to want to discuss this matter publically.”

And neither do YOU

Sharon Hill 5 days ago

“I am thrilled with this piece.”

“My website, Doubtful News, was also a target of the Burzynski PR machine when they tried to shut down critique and questioning.”

Sharon Hill, I’m “doubtful” your website was worth the trouble

But look on the bright side

You just got free “Pub” in a BIASED CENSORING publication

It’ll be something you can tell the grandkids about

“Very pleased that this part of the story is getting out.”

“The bottom line is, there would be no problems if the clinic just met the same standards expected from all clinics – you follow the federal and state rules and you have evidence to back up your claims.”

“The fact that they have to retaliate the way they do is GOOD evidence they have nothing better to show.”

Sharon Hill, and I see that:

“The fact that you have to retaliate the way you do is GOOD evidence you have nothing better to show.”

As in, NO “citation(s),” NO “reference(s),” and / or NO “link(s)” that support your claims

ovalwooki 5 days ago

“Mr. Burzynski is a fraud, a thief, and a scoundrel.”

ovalwooki, so, like YOU ?

“When people are at their lowest, facing death for themselves or a Loved one, he holds out a lie disguised as hope, takes every dime from them that he can, and in some cases even threatens with lawsuits the very people he’s just ripped off.”

ovalwooki, and we should just take your word for it, because, WHY?

“He threatens innocent people who call him out on his horrible record of successful ” cures “ .”

ovalwooki, WHAT is:

“his horrible record of successful ” cures“ ?

“As far as I know, he’s cured no one, ever, and there is no validity to him or his methods, at all.”

ovalwooki, exactly WHAT does:

“As far as I know”

MEAN ?

“He clearly defines what is most flawed with our system of healthcare, here in America.”

ovalwooki, “clearly defines what is most flawed with our system of” yellow journalism, here in America

randy hinton 5 days ago

“In the 1950’s, Congressman Charles Tobey enlisted Benedict Fitzgerald, an investigator for the Interstate Commerce Commission, to investigate allegations of conspiracy* and monopolistic practices on the part of orthodox medicine.”

“This came about as the result of the son of Senator Tobey who developed cancer and was given less than two years to live by orthodox medicine.”

“That is when he learned of alleged conspiratorial practices on the part of orthodox medicine.”

“The final report clearly indicated there was indeed a conspiracy to monopolize the medical and drug industry and to eliminate alternative options.”

guychapman 3 days ago

“That was 60 years ago.”

“And it was not adopted as generally plausible even then.”

guychapman, so, what has changed since then, because there are definitely still dissimulators like YOU?

“By peerless I mean risible, of course.”

guychapman, so, like your comments, right?

JGC2013 4 days ago

“It seems to me there are nly too possibilities here:”

JGC2013, “nly” ?

“1) Antineoplastons don’t work and after two decades and 60-plus uncompleted and unplublished ‘clinical trials’ Burzinsky is fully aware that there is no evidence antineoplastons showing they are effective at treating advanced cancers, but despite this continues to charge patients to receive antineoplaston treatment for financial gain.”

JGC2013, THAT certainly explains THIS:

Burzynski – The Antineoplaston Randomized Japan Phase II Clinical Trial Study:
https://stanislawrajmundburzynski.wordpress.com/2013/03/28/burzynski-the-antineoplaston-randomized-japan-phase-ii-clinical-trial-study
“In which case he’s a fraud, exploiting desparate people for his own personal gain.”

JGC2013, THAT certainly explains THIS:

“Orac” and the “Oracolytes” Cult of Misinformation:
https://stanislawrajmundburzynski.wordpress.com/2013/04/29/orac-and-the-oracolytes-cult-of-misinformation/
“Or 2) antineoplastons DO work, and Burzinsky does have clinical evidence demonstrating efficacybut rather than publish the results of trials (allowing independent oncologists can first confirm and then adopt antineoplatosn therapy) he’s chosen not to publish in order to maintain a lucrative monopoly on antineoplaston herapy, offering it only to the small subset of cancer patients who afford to pay exorbitant fees to be treated at his clinic and effectively denying millions of other cancer patients access to a cure for their cancer.”

JGC2013, THAT certainly explains THIS:
https://stanislawrajmundburzynski.wordpress.com/2013/05/04/critiquing-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics-page-9/
“In which case he’s a monster.”

JGC2013, this is NOT a Rob Zombie film

My 1st-hand Review of Orac’s 2nd-Hand Review – Burzynski: Cancer is Serious Business, Part II:
https://stanislawrajmundburzynski.wordpress.com/2013/03/14/my-1st-hand-review-of-oracs-2nd-hand-review-burzynski-cancer-is-serious-business-part-ii
“I personally can’t envision any third posibility. Can anyone else?”

JGC2013,

3). Citation(s), reference(s), and / or link(s)

guychapman 4 days ago

By a curious coincidence, several senior figures in the pharmaceutical industry today gave evidence to the House of Commons Science and Technology Committee on the specific issue of publication before and after the event for clinical trials and data, and discuss the obligations of those conducting trials.
http://www.parliamentlive.tv/Main/Player.aspx?meetingId=13017 (from approx. 18:44 for the directly relevant content)

guychapman, thank you for keeping us appraised of what’s going in the United Kingdom, home to Kings, Queens, Dukes, Dutchesses, Earls, Counts, Countesses, Knights, Dragons, Wizards, etc., and that fairyland you’re living in

"Figures as low as 70-odd percent and as high as 90+ percent."

guychapman, just in case you have NOT noticed, Burzynski is in the United States of America

Travel Tex
http://www.traveltex.com/
“Texas. It’s like a WHOLE OTHER COUNTRY”

Don’t Mess With Texas

“Nobody citing zero percent as being acceptable or desirable, oddly.”

guychapman, YOU have “zero percent” acceptability or desirability, oddly.

AstroturfWatch 4 days ago

“Hey Peter Lipson, while you were at the Cleveland Clinic, did you speak to Dr. Bruce Cohen, the director of Neuro-oncology?”

“Because he is in “Burzynski Part 1″ and was Paul Michaels neuro-oncologist and watch Paul’s brain tumor “disappear” (after previously telling Paul’s parents “this is the worst case we’ve ever seen”.”

“Dr. Cohen is in the “trailer #2″ from Burzynski, Part 1 also.”

“I think Bruce is still there, perhaps you need to give old Bruce Cohen a call ;)”

Bruce H. Cohen, MD Bio – The United Mitochondrial Disease Foundation
http://www.umdf.org/site/c.8qKOJ0MvF7LUG/b.8047243/k.612C/Bruce_H_Cohen_MD_Bio.htm
Dr. Cohen joined Cleveland Clinic’s department of Neurology, in Cleveland, Ohio , in 1989

guychapman 3 days ago

“You don’t get it do you?”

“Science does not work by assuming that single voices in the wilderness somehow counter the consensus view.”

“The consensus of informed opinion is that Burzynski’s treatment is unproven and not terribly likely to become proven, not least because his science appears incompetent.”

guychapman, are you indicating that Dr. Cohen is NOT competent, and misdiagnosed his patient?

Boris Ogon

“You are right now having a live “debate” in front of more than 10,000 people, … “

3,932 views

Not so much

Waiting for the 10,000

| 4/19/2013 @ 9:43PM

Peter Lipson: “Speech is best countered by more speech”

Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 9)

onforb.es/11pwse9

http://t.co/vh3cgAR6hW

http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics
Didymus Judas Thomas, Contributor

Musings on the intersection of Articles, Bias, and Censorship

(The Big 3: A.B.C.)

4/19/2013 @ 9:43PM

A Film Producer, A Cancer Doctor, And Their Critics

guychapman 5 days ago

“Ah yes, a 1996 news story based on claims from the clinic.”

guychapman, would you like an opportunity to re-read the below and try again?

junkeeroo 1 week ago

The Washington Times, December 5, 1996:

Doctor’s lifesaving effort could land him in prison
– FDA ignores cancer drug’s success

HOUSTON – Federal prosecutors concede that a cancer doctor they will put on trial here in January for using an innovative but unapproved drug has been “saving lives.”

guychapman, that’s NOT

“…claims from the clinic”

“Bold claims, too. Since then he’s registered 61 clinical trials.”

guychapman, that’s NOT taking into consideration the 72 clinical trials listed on the Securities and Exchange (SEC) filings for

11/25/1997 – Form 10-SB

11/25/1997 – Company sponsoring 72 Phase II clinical trials conducted pursuant to INDs filed with FDA which are currently ongoing

“Where are the published results that back his claims?”

guychapman, HERE:

Burzynski Clinical Trials (The SEC filings):
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2
guychapman,

“The FDA is a large organisation made up of all kinds of people from clerks to political appointees.”

“No whistleblowers.”

guychapman, how do YOU know?

Surely YOU do NOT expect people to believe something just because you posted it?

Considering your stellar track-record

Where is your independent reliable citation(s), reference(s), and / or link(s)?

“Great conspiracy, really well controlled.”

guychapman, I posted this on your “blahg:”
http://www.chapmancentral.co.uk/blahg
and it was censored (removed)”:

Are you a coward like “Orac,” @gorskon, @oracknows, @ScienceBasedMed, Dr. David H. Gorski?
http://burzynskimovie.com/images/stories/transcript/Documents/BurzynskiTriesToExposeNCI.pdf
“Especially since it necessarily also covers MSKCC, NCI, ACS, CRUK and dozens of other organisations.”

guychapman, where are their reliable independent antineoplaston clinical studies?

“I think the number of people engaged in actively suppressing Burzynski’s miracle cure must be in the hundreds of thousands by now and includes lab technicians, scientists, doctors, regulators, politicians and charities in at least ten countries.”
http://t.co/N7ErbunCV2
guychapman, like THIS?
redd.it/1dk974
Wikipedia, what’s your motivation?
http://redd.it/1dk974
Didymus Judas Thomas’
http://www.reddit.com/tb/1dk974
Hipocritical Oath Blog
https://stanislawrajmundburzynski.wordpress.com/2013/05/02/wikipedia-whats-your-motivation/
“Conspiracies that watertight could give you the world on a plate.”

“I mean, Watergate only involved a handful of people and it was busted almost immediately.”

guychapman, you employ a favorite tactic of critics like you

It seems you are more interested in addressing form (CAPITALIZATION) over substance (the real issues)

Maybe you think that your verbosity (17 posts) will somehow lend credibility to your 3 comments re the Declaration of Helsinki; which does NOT state WHEN human clinical trial results MUST be published, and even though you have repeatedly proclaimed that Burzynski has NOT published the FINAL results of any of his phase 2 clinical trials, you have NOT provided any indication as to WHEN any of those trials were completed so that they can be compared to the 2006 study I cited whose results were published in 2013

You also commented:

“In order to claim that he can cure incurable tumours, he needs to publish high quality clinical trial evidence in peer-reviewed journals,”

yet you do NOT provide any citation, reference, or link that overrides the National Cancer Institute (NCI) at the National Institutes of Health (NIH) information re publication which I have commented on previously.

It is apropo you commented:

“Watergate only involved a handful of people and it was busted almost immediately,”

since President Nixon is credited with starting the

“War on Cancer”

and when Watergate occurred he was told that there was a cancer on the Presidency, but Watergate occurred in 1972 and Nixon didn’t resign until 2 years later, in 1974

It is also appropriate that you mention oncologist David Gorski; who disclosed on social media that Peter Lipson is his “pal”

Did you review Burzynski’s 2003-2006 phase 2 clinical trials preliminary reports to see if any of the authors listed on them is an oncologist?

No?

That’s why your observation that Burzynski (a biochemist) is NOT an oncologist, is irrelevant

Do you have any proof to back up your remarkable claim:

“Against that we have an anonymous shill who takes every word of the Burzynski clinic and its supporters as Revealed Truth”?

No?

That’s because you’re wrong about that just like the other issues I’ve listed above

Mr. Chapman, you attempts at obfuscation of the issues, does not impress

guychapman 5 days ago

You don’t really understand the scientific concept of proof do you?

guychapman, you do NOT really understand the concept of proof, do you?

“That probably explains why you are swallowing Burzynski’s PR hook line and sinker.”

guychapman, NO, unlike you, I actually reviewed things and am able to provide “citations,” “references,” and / or “links”

“In order to claim that he can cure incurable tumours, he needs to publish high quality clinical trial evidence in peer-reviewed journals.”

guychapman, where is your “citation(s),” “reference(s),” and / or “link(s)”?

“He needs to publish his science in a way that others can understand and replicate.”

guychapman, do you mean, like THIS?

Stanislaw Rajmund Burzynski Publications:
https://stanislawrajmundburzynski.wordpress.com/2013/03/16/stanislaw-rajmund-burzynski-publications
Burzynski updates Scientific Publications page:
https://stanislawrajmundburzynski.wordpress.com/2013/03/12/burzynski-updates-scientific-publications-page
Antineoplastons, which were first described by Burzynski:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/antineoplastons-which-were-first-described-by-burzynski
Burzynski: Poland antineoplaston publications:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-poland-antineoplaston-publications
Burzynski: South Korea antineoplaston publications:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-south-korea-antineoplaston-publications
Burzynski: Russia antineoplaston publications:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-russia-antineoplaston-publications
Burzynski: Egypt antineoplaston publications:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-egypt-antineoplaston-publication
Burzynski: Japan antineoplaston publications:
https://stanislawrajmundburzynski.wordpress.com/2013/02/19/burzynski-japan
Burzynski: China antineoplaston publications:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-china-antineoplaston-publications
Burzynski and China / Taiwan, ROC:
https://stanislawrajmundburzynski.wordpress.com/2013/02/18/burzynski-china-taiwan-roc
Burzynski and Taiwan, ROC
https://stanislawrajmundburzynski.wordpress.com/2013/02/20/burzynski-taiwan-roc
Burzynski, China, and Dvorit D. Samid:
https://stanislawrajmundburzynski.wordpress.com/2013/02/21/burzynski-china-dvorit-d-samid
Burzynski, Ming-Cheng Liau, and Gi-Ming Lai:
https://stanislawrajmundburzynski.wordpress.com/2013/02/24/burzynski-ming-cheng-liau-gi-ming-lai
Review Article: Antineoplastons:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/review-article-antineoplastons
Burzynski – The Antineoplaston Randomized Japan Phase II Clinical Trial Study:
https://stanislawrajmundburzynski.wordpress.com/2013/03/28/burzynski-the-antineoplaston-randomized-japan-phase-ii-clinical-trial-study
“The people who need to understand and replicate his work in order to validate it, have been complaining for two decades and more that he has failed to do this.”

guychapman, WHO are “The people”?

“The appeal to conspiracy as an excuse for failure to publish any compelling results is a stable feature of quackery.”

guychapman, YOU ARE part of the “conspiracy” as long as you remain silent and play “dumb” about things like “censorship” and “bias” by Wikipedia; who you are the “apologist” for, and Forbes

“It is not a feature of science as such.”

And neither is your ignorance and inability to provide any citation(s), reference(s), and / or link(s)

guychapman 5 days ago

“That was 1996. Since then he’s registered 60 phase II and eon phase III clinical trials.”

guychapman, “eon”?

“Of these he has completed only one, and has failed to publish any meaningful data from any”

guychapman, where is your in-depth review of these publications?

Drugs in R and D (Drugs in Research and Development)

Drugs R D. 2003;4(2):91-101
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs R D. 2004;5(6):315-26
http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
Integrative Cancer Therapies

Integr Cancer Ther. 2005 Jun;4(2):168-77
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
Integr Cancer Ther. 2006 Mar;5(1):40-7
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
2007
http://www.cancer-therapy.org/CT/v5/B/HTML/42._Burzynski,_379-390.html

http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf
Critiquing “The Skeptic” Burzynski
redd.it/1dld1j
Critics: A Film Producer, A Cancer
http://redd.it11dld1j
Doctor, And Their Critics (page 8)
http://www.reddit.com/tb/1dld1j

https://stanislawrajmundburzynski.wordpress.com/2013/05/03/critiquing-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics-page-8/
“(which is in contravention of the Helsinki Protocol governing human trials).”

guychapman, exactly WHERE does the Declaration of Helsinki indicate THAT?

Burzynski: Declaration of Helsinki
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-declaration-of-helsinki
“There’s only so much cherry picking you can do.”

guychapman, YOU are the “cherry-picking” King

“The scientific consensus is based on the totality of evidence, or rather in this case the totality of lack of credible evidence.”

guychapman, YOU have NOT provided “credible evidence” of anything, other than your own ignorance:

The dishonesty of Guy Chapman, “The Skeptics” shill
https://stanislawrajmundburzynski.wordpress.com/2013/04/12/the-dishonesty-of-guy-chapman-the-skeptics-shill
guychapman 5 days ago

“PDJT aka “Astroturfwatch” – the irony of a contributor to an astroturfing campaign of the magnitude of Burzynski’s calling skeptics for non-existent astroturfing is amusing.”

guychapman, are you related to, or know this “lilady”?

Orac, a lilady, the
redd.it/1dgqa1
Oracolytes: “The Skeptic” Burzynski Critics: A
http://redd.it/1dgqa1
Film Producer, A Cancer Doctor, And
http://www.reddit.com/tb/1dgqa1
Their Critics:
https://stanislawrajmundburzynski.wordpress.com/2013/05/01/orac-a-lilady-the-oracolytes-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics/
because you sound similar to lilady with your ASSumptions
“You say:”

“Find just one, any single cure for this tumor type and you can’t, outside of Antineoplastons”

guychapman, NO, “you” did NOT say that, since I am NOT “you”

(Forbes)

Didymus Thomas 5 days ago

As former President Ronald Reagan used to say: “Well, there you go again.”

Let me make this perfectly clear and unambiguous as I can.

1. I am NOT Dr. Stanislaw R. Burzynski, I have never worked for him, I have never met him.

2. I am NOT AstroTurfWatch.

3. I am NOT Eric Merola, I have never worked for him, I have never met him.

4. I am NOT Randy Hinton, I have never met him, this article is the first place I have seen his name.

“What you mean is:”

“Find just one, any single cure for this tumor type and you can’t, including Antineoplastons”.

guychapman, when are you going to show whether you are just a coward or not, and PROVE IT?

“Because the point about which you are in denial is that there is no credible evidence that antineoplastons cure anything.”

guychapman, WHAT does this indicate?

The FDA’s Drug Review Process:

Ensuring Drugs Are Safe and Effective

“[T]he emphasis in Phase 2 is on EFFECTIVENESS”

“This phase aims to obtain PRELIMINARY DATA on whether the drug works in people who have a certain disease or condition”

“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2″

“These studies gather more information about safety and EFFECTIVENESS, studying different populations and different dosages and using the drug in combination with other drugs”
http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm
“The endlessly repeated list of low quality publication does not come anywhere close to filling in the gap which ought to be filled by the sixty-one human trials he never published – and all the available evidence indicates he never had any intention of doing so.”

guychapman, WHAT does this indicate?

The “FACT” one should know is that clinicaltrials . gov does NOT contain the same data as the National Cancer Institute (NCI) at the National Institutes of Health (NIH) cancer . gov web-site:

61 TOTAL
1 – Not Yet Recruiting (Open)(Phase 3)
1 – Closed
2 – Terminated (Withdrawn due to slow enrollment)
7 – Withdrawn (This study has been withdrawn prior to enrollment)
10 – Recruiting (Open)
11 – Open (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)

The below 1st link: 10 Active (Open):
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11475951
The below 2nd link: 25 Closed-1st screen / 15 Closed-1 Completed-2nd screen:
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11476036
NONE of the above are “UNKNOWN” per the above 2 National Cancer Institute (NCI) at the National Institutes of Health (NIH) links:

10 – Recruiting (Open)
11 – Open (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)

10=Open
11=1 Not Yet Recruiting / 10 Recruiting
40=Closed
61-TOTAL

“I don’t think he cares any more about the Helsinki Declaration than he does about any other area of medical ethics.”

guychapman, have you even read the Declaration of Helsinki?

Because if you had, you should be able to indicate which section supports your comment

WHAT was that you were saying about “ethics”?

guychapman 5 days ago

“There’s an interesting parallel with Burzynski here.”

guychapman, there’s an interesting parallel with guychapman, Guy Chapman, @SceptiGuy, @vGuyUK, and the Wikipedia Guys: JzG|Guy and Guy (Help!)
http://t.co/N7ErbunCV2
Wikipedia, what’s your motivation?
redd.it/1dk974
Didymus Judas Thomas’
http://redd.it/1dk974
Hipocritical Oath Blog
http://www.reddit.com/tb/1dk974

https://stanislawrajmundburzynski.wordpress.com/2013/05/02/wikipedia-whats-your-motivation/
“Hoxsey, too, used patient anecdotes and conspiracy theories to sustain his business in the absence of credible evidence for a cure;”

guychapman, thank you for bringing up the issue of:

“absence of credible evidence”

THAT describes you to a “T”

If the shoe fits, wear it

“How do you recommend we should tell the difference between Burzynski and his shill Merola, and the palpable fraud and quack Hoxsey?”

guychapman,

“How do you recommend we should tell the difference between guychapman and his shill Guy Chapman, and the palpable fraud and quack @SceptiGuy / @vGuyUK?”

Guy (Help!)

User:JzG/help|Help!

Trust me, Guy, nothing can help YOU

Boris Ogon 6 days ago

“One interesting element is that Merola himself hasn’t shown up to defend his vexatious DMCA claim, which he has effectively admitted to be meritless by offering to drop it if c0nc0rdance can somehow get the after-the-fact third-party mirrors to not include his E-mail address.”

Boris Ogon, did you entirely ignore the Forbes article?

"A well-known “vlogger” who goes by the handle “C0nc0rdance” reports receiving a DMCA take-down notice from Eric Merola after posting a video critical of Burzynski."

"According to C0nc0rdance:
He objected to my “Fair Use” of a small low-res image of his movie poster.”

“Instead, he drops a post on his Facebook page complaining about this article and mischaracterizing the situation, and 10 minutes later, his adherents appear and start babbling incoherently.”

Boris Ogon, are you referring to THIS?

My review of C0nc0rdance:
redd.it/1dm31j

http://redd.it/1dm31j

http://www.reddit.com/tb/1dm31j

https://stanislawrajmundburzynski.wordpress.com/2013/03/23/my-review-of-c0nc0rdance
Mr. Ogon, I guess you were too lazy to type it, sort of like your “research”?

Burzynski, The Movie shared a link.
about an hour ago

“Wow, and people say the “Skeptics” (aka Astroturf campaign) aren’t powerful and with the system behind them.”

“This is what happens when I take down a YouTube video making false claims against my film and Burzynski as well as illegally using copyrighted images of me without permission within (not to mention publishing my personal emails in which I received countless profanity filled threats also in their YouTube post, and they claim “we” threaten – this is the system fighting back, hard):

“Again, Eric: Section 512(f) isn’t entirely toothless.”

Mr. Ogon, though your “research,” IS

"Send some more bogus takedowns and see what happens."

Mr. Ogon, do you mean THIS?

Dr. Peter A. Lipson (and / or his Censor(s)) is a Coward: Critiquing

“A Film Producer, A Cancer Doctor, And Their Critics:”
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/dr-peter-a-lipson-and-or-his-censors-is-a-coward-critiquing-a-film-producer-a-cancer-doctor-and-their-critics
Dr. Lipson does not opine about the manufactured “hysteria” activities by the Burzynski “Critics,” that occurred on Twitter, YouTube, and other social media sites, which entailed this “fact-challenged” video being “mirrored” (duplicated), a ridiculous amount of times

Boris Ogon 5 days ago

For anyone unfamiliar with the tiresome tactic of “Didymus [Judas] Thomas” of trying to drive signal-to-noise ratio into the ground while being completely unable to respond coherently, this is not a bad place to start:
http://goo.gl/f59kT
He was eventually blocked under the “Competence is Required” policy and started shooting off typically garbled E-mails to Jimmy Wales demanding personal attention.

Mr. Ogon, do you have a relationship with Wikipedia?

Mr. Ogon, did you research THIS on Wikipedia?

[“Remedies may be appealed to, and amended by, Jimbo Wales, …”

([[WP:AP]] Wikipedia:Arbitration/Policy 2.9 Appeal of decisions)]

Mr. Ogon, are you referring to THIS?
http://t.co/N7ErbunCV2
Wikipedia, what’s your motivation?
redd.it/1dk974
Didymus Judas Thomas’
http://redd.it/1dk974

http://www.reddit.com/tb/1dk974
Hipocritical Oath Blog
https://stanislawrajmundburzynski.wordpress.com/2013/05/02/wikipedia-whats-your-motivation/
Mr. Ogon, why don’t you bring your coward self over to my blog where I do NOT censor comments, and let’s find out how you do under Sunshine and Blue Sky?

Boris Ogon

“You are right now having a live “debate” in front of more than 10,000 people, … “

3,907 views

Not so much

Waiting for the 10,000

4/19/2013 @ 9:43PM

Peter Lipson: “Speech is best countered by more speech”

Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 7)

onforb.es/11pwse9

http://t.co/vh3cgAR6hW

http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics
Didymus Judas Thomas, Contributor

Musings on the intersection of Articles, Bias, and Censorship

(The Big 3: A.B.C.)

4/19/2013 @ 9:43PM

A Film Producer, A Cancer Doctor, And Their Critics

FW 6 days ago

"“Making people undergo clinical trials that hold no promise” – Quite, it is abhorrent that Burzynski does this, and has been doing it for many years."

FW (also known as @frozenwarning), has no proof that anyone is “Making people undergo clinical trials…"

FW continues:

"The FDA was ordered by a scientifically illiterate judge to allow these trials, they had no choice."

FW again makes an unsubstantiated claim

"That the FDA hasn’t stopped this charade is bizarre and inexcusable IMO."

FW, the FDA knows what is going on, unlike you

"Hopefully that will soon happen."

FW, it doesn't look like it:
http://www.china-burzynski.com

http://www.china-burzynski.com/lczl/bingrengushi_135135.html

http://www.china-burzynski.com/lxwm
"There is, as yet, no evidence that he has cured any type of cancer, all we have are a few, mainly historical anecdotes."

FW, have you seen this?

"The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective" advises:

“[T]he emphasis in Phase 2 is on EFFECTIVENESS”

“This phase aims to obtain PRELIMINARY DATA on whether the drug works in people who have a certain disease or condition”

“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2″

“These studies gather more information about safety and EFFECTIVENESS, studying different populations and different dosages and using the drug in combination with other drugs”
http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm
"By the way, the Phase 3 trial that is registered to Burzynski is not for brain tumours, sorry to disappoint you."

FW, are you saying that you do NOT know what you are writing about?

Because, that is what it looks like to me

Burzynski's Securities and Exchange Commission (SEC) Form 10-Q for the quarterly period ended 5/31/2010 states:

1/13/2009 Company announced Company had reached an agreement with FDA for Company to move forward with pivotal Phase III clinical trial of combination Antineoplaston therapy plus radiation therapy in patients with newly diagnosed, diffuse, intrinsic brainstem gliomas (DBSG)

Agreement was made under FDA’s Special Protocol Assessment procedure, meaning design and planned analysis of Phase III study is acceptable to support regulatory submission seeking new drug approval

2/1/2010 Company entered into agreement with Cycle Solutions, Inc., dba ResearchPoint to initiate and manage pivotal Phase III clinical trial of combination Antineoplastons A10 and AS2-1 plus radiation therapy (RT) in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma

ResearchPoint is currently conducting feasibility assessment

ResearchPoint has secured interest and commitment from number of sites selected

Upon completion of assessment, randomized, international phase III study will commence

Study's objective is to compare overall survival of children with newly-diagnosed DBSG who receive combination Antineoplastons A10 and AS2-1 plus RT versus RT alone

AstroturfWatch 6 days ago

AstroturfWatch, in referring to the author of the article, as well as some of the individuals who posted comments unsupported by any facts, stated:

"And truth and integrity is not an option for them."

"They refuse to fact check anything."

"Anyone can be a journalist nowadays, and “fact-checking” is no longer even on the table."

I proved those statements to be true:

A Film Producer, A Cancer Doctor, And Their Critics:
https://stanislawrajmundburzynski.wordpress.com/2013/04/20/a-film-producer-a-cancer-doctor-and-their-critics
Forbes censors Peter Lipson
http://www.reddit.com/tb/1czvol
“Speech is best countered by more speech” article comments:
https://stanislawrajmundburzynski.wordpress.com/2013/04/23/forbes-censors-peter-lipson-speech-is-best-countered-by-more-speech-article-comments
Dr. Peter A. Lipson (and / or his Censor(s)) is a Coward: Critiquing “A Film Producer, A Cancer Doctor, And Their Critics:"
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/dr-peter-a-lipson-and-or-his-censors-is-a-coward-critiquing-a-film-producer-a-cancer-doctor-and-their-critics
Critiquing “The Skeptic” Burzynski
http://t.co/n1IzlVmZEu

http://reddit.it/1d8am2
Critics: A Film Producer, A Cancer
http://www.reddit.com/tb/1d8am2
Doctor, And Their Critics (page 1)
https://stanislawrajmundburzynski.wordpress.com/2013/04/27/critiquing-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics-page-1/
Critiquing “The Skeptic” Burzynski
http://reddit.it/1d922h
Critics: A Film Producer, A Cancer
http://www.reddit.com/tb/1d922h
Doctor, And Their Critics (page 2)
https://stanislawrajmundburzynski.wordpress.com/2013/04/28/2-critiquing-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics-page-2/
Critiquing “The Skeptic” Burzynski
http://reddit.it/1daz6g
Critics: A Film Producer, A Cancer
http://www.reddit.com/tb/1daz6g
Doctor, And Their Critics (page 3)
https://stanislawrajmundburzynski.wordpress.com/2013/04/29/critiquing-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics-page-3/
Critiquing “The Skeptic” Burzynski
http://t.co/KnWNoDeWYT

http://reddit.it/1dc3ka
Critics: A Film Producer, A Cancer
http://www.reddit.com/tb/1dc3ka
Doctor, And Their Critics (page 4)
https://stanislawrajmundburzynski.wordpress.com/2013/04/29/critiquing-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics-page-4/
Critiquing “The Skeptic” Burzynski
http://redd.it/1df875
Critics: A Film Producer, A Cancer
http://www.redd.com/1df875
Doctor, And Their Critics (page 5)
https://stanislawrajmundburzynski.wordpress.com/2013/04/30/critiquing-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics-page-5/
Critiquing “The Skeptic” Burzynski
http://redd.it/1dg2w9
Critics: A Film Producer, A Cancer
http://wew.redd.com/1dg2w9
Doctor, And Their Critics (page 6)
https://stanislawrajmundburzynski.wordpress.com/2013/04/30/critiquing-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics-page-6/
Critiquing “All truth comes from
http://www.reddit.com/tb/1d9hsa

http://redd.it/1d9hsa
public debate”: A corollary to crank
http://www.reddit.com/tb/1d9hsa
magnetism
https://stanislawrajmundburzynski.wordpress.com/2013/04/28/critiquing-all-truth-comes-from-public-debate-a-corollary-to-crank-magnetism/
IMPORTANT: The live “debate”-A Film Producer, A Cancer Doctor, And Their Critics
https://stanislawrajmundburzynski.wordpress.com/2013/04/27/important-the-live-debate-a-film-producer-a-cancer-doctor-and-their-critics/
IMPORTANT: The live “debate”
http://t.co/KnWNoDeWYT

http://redd.it/1dcja2
that wasn’t-A Film Producer, A
http://www.reddit.com/tb/1dcja2
Cancer Doctor, And Their Critics
https://stanislawrajmundburzynski.wordpress.com/2013/04/29/important-the-live-debate-that-wasnt-a-film-producer-a-cancer-doctor-and-their-critics/
Orac, a lilady, the Oracolytes: “The
http://redd.it/1dgqa1
Skeptic” Burzynski Critics: A Film
http://www.reddit.com/tb/1dgqa1
Producer, A Cancer Doctor, And Their Critics
https://stanislawrajmundburzynski.wordpress.com/2013/05/01/orac-a-lilady-the-oracolytes-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics/
Orac and the Oracolytes
http://redd.it/1defev
“Orac” and the “Oracolytes” Cult of
http://www.redd.com/1defev
Misinformation
https://stanislawrajmundburzynski.wordpress.com/2013/04/29/orac-and-the-oracolytes-cult-of-misinformation/
FW 6 days ago

"So you’d rather get your information from an advertising film than doctors, scientists and researchers."

Dr. Burzynski is a doctor, as is his wife, and if you look at the co-authors on his clinical trial publications, and actually research them, you can determine what they are, as well

"That’s your choice, misguided though it is."

If anyone has been "misguiding" anyone, I would say that it is the author, you, and a number of other individuals who posted comments

"Don’t expect rational people to stop trying to stop Burzynski though."

I do NOT see that you've been "rational"
"What he is doing is unscientific, unethical and immoral."

It's good to learn that you are now judge, jury, and executioner

You remind me of Wikipedia

"Also, the moon landings were real."

FW, it's good to learn that at least you got one thing correct

junkeeroo 6 days ago

FW, I understand that for you “rational and intelligible” means that it corresponds to your biased framework.

Perhaps one day you or your conscience will awaken to reality.

junkeeroo, good point, but I do NOT believe its going to happen any time soon

junkeeroo 6 days ago

re: rather “than doctors, scientists and researchers”

You truly do live in lala-land.

Best of luck to you…

What junkeeroo said

Author

Peter Lipson, Contributor 6 days ago

"There is ZERO published data to support these assertions."

"Please, if you know of something out there other than what you saw in a movie, let us know."

Dr. Lipson, if that's what you call these, oh, well

Burzynski Clinical Trials (The SEC filings)
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2
Called-out comment

AstroturfWatch 6 days ago

Internationally peer-reviewed published data, page 172
(page 8 of PDF):

Brainstem glioma.

Never been cured in history.

Antineoplastons first ever cures.
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf
FW 6 days ago

"I have no particular interest int he FDA as I work for the NHS in the UK,which also doesn’t support Burzynski due to the lack of evidence on efficacy and safety, and the dubious practices."

FW, sounds like you could use a little help, just like Dr. Lipson:

Burzynski Clinical Trials (The SEC filings)
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2
"Merola doesn’t investigate, he is a blind disciple of Burzynski."

FW, from what I can tell, if anyone has proven to be a "blind disciple," it has been YOU

"Not once has he addressed the perfectly valid criticisms."

FW, I said it before and I'll say it again:

It’s a bit hard to address anything when Forbes is censoring (deleting) your comments

"Let’s look at it this way, if Burzynski had a 25% success rate, why has he not published this miraculous data?"

"Yet again, you show that Burzynski supporters do not know what they are reading."

FW, on the subject of people NOT knowing what they are reading, you do NOT appear very knowledgeable, considering your lack of any citation(s), reference(s), and / or links

Boris Ogon

“You are right now having a live “debate” in front of more than 10,000 people, … “

Peter Lipson, Contributor
Musings on the intersection of science, medicine, and culture

3,799 views

Not so much

Waiting for the 10,000

4/19/2013 @ 9:43PM

Peter Lipson: “Speech is best countered by more speech”

Orac, a lilady, the Oracolytes: “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics

http://t.co/vh3cgAR6hW

onforb.es/11pwse9

http://t.co/vh3cgAR6hW

http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics
Randy Hinton issued a challenge on this Forbes (#Forbes) article by Peter Lipson

randy hinton 1 week ago

“So anytime you want to come out from behind your keyboard and debate this in front of 10,000 people LIVE and I will make you cry like a baby and beg for your mama.”

“Orac,” then posted on his blog:
http://scienceblogs.com/insolence
“All truth comes from public debate”: A corollary to crank magnetism
Posted by Orac on April 26, 2013

http://scienceblogs.com/insolence/2013/04/26/all-truth-comes-from-public-debate-a-corollary-to-crank-magnetism/
“Orac” posted my tweet:

“The SkeptiCowards”couldn’t handle a live Debate
They believe in “Free Speech”as long as it’s their speech-that takes the Cake!
#Burzynski

— QbertQbert (@QbertQbert) April 26, 2013

“Orac” commented:

“One also can’t help but note a similarity here between DJT and Mr. Hinton, but what that means I will leave to each individual reader to decide for him or herself.”

lilady posted:

#32 – lilady – April 26, 2013

“I think it is incredibly sad that yet another politician has been taken in by a Burzynski patient’s family…make that a potential patient of Burzynski.”

“I suspect that Mr. Hinton and Congressman Duncan do not have the ability to evaluate how Dr. Burzynski has been scamming vulnerable patients and their families for more than thirty years.”

lilady proceeded to make ASSumptions about Mr. Hinton’s daughter on the Forbes article comments:

lilady 4 days ago

“Mr. Hinton”

“Instead of attacking oncologists who tried to help your child and didn’t play fast and loose with her prognosis, might I suggest that you direct your animosity and your research skills toward Stanislaw Burzynski?”

“One of my favorite science bloggers, who is a cancer surgeon, has written extensively about Dr. Burzynski, his clinic and his lack of Stage 3 trials…in addition to Dr. Burzynski’s charging patients and their families exorbitant fees for his doomed to failure treatments.”

“You made a statement about debating…”

“So anytime you want to come out from behind your keyboard and debate this in front of 10,000 people LIVE and I will make you cry like a baby and beg for your mama.”

“I’m taking you up on that challenge and inviting you to join the discussion at this science blog:”
http://scienceblogs.com/insolence/2013/04/26/all-truth-comes-from-public-debate-a-corollary-to-crank-magnetism/
lilady then reported back to “Orac” and the “Oracolytes:”

#43 – lilady – April 26, 2013

“Randy Hinton has been posting on a Forbes blog about Burzynski”

“(Expand All Comments).”

“Scroll over to Page 3 to see his rant and his challenge to debate people.”

“I replied to him (Page 4) and invited him to join us on RI to discuss/debate Burzynski’s treatment.”

“He hasn’t replied to me.”
http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics/#comment-170
Mr. Hinton set lilady straight about her “fact-challenged” inaccurate statement on Forbes:

“”Instead of attacking oncologists who tried to help your child and didn’t play fast and loose with her prognosis…”

randy hinton 3 days ago

“I have heard this propaganda crap now for 6 year’s and I know the fact’s.”

“I will not waste my time with a CHAT on line where you people alway’s control the conversation.”

“ANYTIME you want to debate this in front of a live audience, all you have to do is set it up as long as there are no restriction’s on what is said or expressed.”

“If you do this I promise you that you will end up so embarrassed it will take you a year to get over it.”

“Stanislaw Burzynski was the only one who told the truth to me at all and the Ronald McDonald House refused us a room because we were at his clinic.”

“Then Texas Children’s Hospital REFUSED TO PUT A SHUNT IN MY DAUGHTER’S HEAD because we would go back to his clinic.”

“Then M.D.Anderson repeatedly ignored me when I pointed out a problem about my daughter over and over again and this lead to a MASSIVE seizure that put her out of commission for 3 day’s.”

“THEN they admitted they screwed up.”

“Then 2 year’s later I learn that the trial that MUSC told me did not exist and the treatment that MUSC told me did not exist HAD SAVED 4 ASTROCYTOMA AND 2 PONTINE GLIOMA PATIENT’S without radiation or chemotherapy and the FDA told me.”

“SO ANYTIME YOUR READY BOY.”

lilady, instead of apologizing for her previous gaff, proceeded with the kind of comments one can expect from a true Skeptic on Forbes:

lilady 3 days ago

“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”.”

“I’m calling you out on your anecdotal stories and your support of Burzynski’s *treatment*. So prove me wrong by coming to this blog:”
http://scienceblogs.com/insolence/2013/04/26/all-truth-comes-from-public-debate-a-corollary-to-crank-magnetism/
lilady again, then reported back to “Orac” and the “Oracolytes:

#58 – lilady – April 27, 2013

“Randy Hinton posted a comment 8 hours ago on Peter Lipson’s Forbes blog…now demanding a “public debate”.”

“(Expand All Comments-pg 11)”
http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics/
“randy hinton 8 hours ago”

(Mr. Hinton’s comments from Forbes)

lilady continues:

“I again posted back at him”

“lilady 10 minutes ago”comments from Forbes)
http://scienceblogs.com/insolence/2013/04/26/all-truth-comes-from-public-debate-a-corollary-to-crank-magnetism/
I could NOT resist commenting:

Didymus Thomas 3 days ago

“Ha ! This “oncologist” refused to reply to my post on his blog, months ago!”

“Now he’s going to “debate”?”

I posted on my blog:

IMPORTANT: The live “debate”-A Film Producer, A Cancer Doctor, And Their Critics
https://stanislawrajmundburzynski.wordpress.com/2013/04/27/important-the-live-debate-a-film-producer-a-cancer-doctor-and-their-critics/
lilady then proceeded to make more ASSumptions on Forbes:

lilady 2 days ago

“Ha Didymus Thomas…You opened your huge tin of Spam, months ago! And, you “Didymous Judas Thomas” and your sock puppets were banned by Wikipedia.”
http://en.wikipedia.org/wiki/Category:Suspected_Wikipedia_sockpuppets_of_Didymus_Judas_Thomas
lilady ASSumes that I had “sock puppets” on WP, but is unable to cite who those “alleged” sock puppets were

lilady continues with yet another of her “factually-challenged” ASSumptions:

“You and Randy Hinton are sounding suspiciously alike.”

Yeah, like THIS:

“Orac” and the “Oracolytes” Cult of Misinformation | Didymus Judas
http://redd.it/1defev
Thomas’ Hipocritical Oath Blog
https://stanislawrajmundburzynski.wordpress.com/2013/04/29/orac-and-the-oracolytes-cult-of-misinformation/
#142
“Orac” and the “Oracolytes” Cult of Misinformation | Didymus Judas Thomas’ Hipocritical Oath Blog
April 29, 2013

[…] http://scienceblogs.com/insolence/2013/04/26/all-truth-comes-from-public-debate-a-corollary-to-crank…
[…]
lilady again, for the 3rd time, reports back to “Orac” and the “Oracolytes:
#71 – lilady – Here, and still waiting for Randy Hinton. – April 27, 2013

“Randy Hinton has not replied to my two posts on Peter Lipson’s Forbes blog and my invitations to “debate” here….but DJT, just replied in his stead.”

“See pg 11 (Expand All Comments)”
http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics/
I posted a reply to “Orac’s” blog, on my blog:

(which shows up on “Orac’s blog)

Critiquing “All truth comes from public debate”: A corollary to crank magnetism
https://stanislawrajmundburzynski.wordpress.com/2013/04/28/critiquing-all-truth-comes-from-public-debate-a-corollary-to-crank-magnetism/
#77
http://www.reddit.com/tb/1d9hsa
Critiquing “All truth comes from public debate”: A corollary to crank magnetism:
http://www.reddit.com/tb/1d9hsa
April 28, 2013
[…] http://scienceblogs.com/insolence/2013/04/26/all-truth-comes-from-public-debate-a-corollary-to-crank…
[…]
“Orac” posted on his blog:

#85 – Orac – April 28, 2013

“I’m calling you out on your anecdotal stories and your support of Burzynski’s *treatment*.”

“So prove me wrong by coming to this blog:”

“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.”

“Mr. Hinton, however, may comment if he so desires, but he has to do it under his own name.”

I then posted on my blog:

(which shows up on “Orac’s blog)

IMPORTANT: The live “debate” that wasn’t-A Film Producer, A Cancer Doctor, And Their Critics
https://stanislawrajmundburzynski.wordpress.com/2013/04/29/important-the-live-debate-that-wasnt-a-film-producer-a-cancer-doctor-and-their-critics/
#137
http://t.co/KnWNoDeWYT
IMPORTANT: The live “debate” that wasn’t-A Film Producer, A Cancer Doctor, And Their Critics | Didymus Judas Thomas’ Hipocritical Oath Blog
http://www.reddit.com/tb/1dcja2
April 29, 2013
[…]
#142 – “Orac” and the “Oracolytes” Cult of Misinformation | Didymus Judas Thomas’ Hipocritical Oath Blog
April 29, 2013

[…] http://scienceblogs.com/insolence/2013/04/26/all-truth-comes-from-public-debate-a-corollary-to-crank…
[…]
lilady posted on Forbes:

“So, Randy Hinton, will you be debating a real surgical oncologist? Or are you one of DJT’s sockies?”

I replied:

Didymus Thomas 2 days ago

As former President Ronald Reagan used to say:

“Well, there you go again.”

Let me make this perfectly clear and unambiguous as I can.

1. I am NOT Dr. Stanislaw R. Burzynski, I have never worked for him, I have never met him.

2. I am NOT AstroTurfWatch.

3. I am NOT Eric Merola, I have never worked for him, I have never met him.

4. I am NOT Randy Hinton, I have never met him, this article is the first place I have seen his name.

lilady replied back with her “day old fish” ASSumption:

lilady 2 days ago

“But you ARE Didymus Judas Thomas, who, along with his/her sock puppets, are banned from Wikipedia:”
http://en.wikipedia.org/wiki/Category:Suspected_Wikipedia_sockpuppets_of_Didymus_Judas_Thomas
Again, like a true “Skeptic,” lilady ASSumed that I had “sock puppets” on WP, but is unable to cite who those “alleged” sock puppets were

lilady continued:

“So, Randy Hinton…why don’t you post at the blog I linked to?”

lilady, who must NOT have understand Mr. Hinton’s comment:

“I will not waste my time with a CHAT on line where you people alway’s control the conversation”

I replied back on Forbes:

Didymus Thomas 2 days ago

1. Do you have a point ?

2. Do you have a relationship with Wikipedia?

3. Why is it that on the Wikipedia “Brainstem Glioma” Prognosis page it has “needs citations,” when I can do an Internet search and find reliable independent sources for that information?

4. Do you really want to get into a debate about WP, or do you want to handle one issue at a time?

5. “The U.S. v. Article’~ court stated that the FDA’s responsibility was to protect the ultimate consumer, which included protection of “the ignorant, the unthinking and the credulous.”‘

I posted number 5, since I thought it most aptly described the “lilady” I was dealing with

lilady replied on Forbes:

lilady 2 days ago

“I have no connection with Wikipedia and you and your sock puppets have been banned from the site.”

“Your posts only indicate that you and your sockies’ Spam are ignorant in basic science and cancer treatment.”

I replied:

Didymus Thomas 1 day ago

1. lilady, please explain what you did bit (sic-“not”) understand re Randy Hinton’s comment:

“I will not waste my time with a CHAT on line where you people alway’s control the conversation”

2. The fact that you were not able to offer a coherent response to point 3 of my reply says it all

3. WP claims to have a neutral policy: “The principles upon which this ‘policy’ is based cannot be superseded by ‘other policies’”

Yet, even WP apologist, Guy Chapman is unable to explain why, when WP claims ‘other policies’ are supposedly “co-equal” with the neutral policy, that none of those ‘other policies’ also indicate that: “The principles upon which this ‘policy’ is based cannot be superseded by ‘other policies’”

4. As former President George Herbert Walker Bush said: “Read … my … lips”

Most Read on Forbes

lilady has been silent since then on Forbes and on “Orac’s” “debate” blog

Boris Ogon

“You are right now having a live “debate” in front of more than 10,000 people, … “

3,796 views

Not so much

Waiting for the 10,000

4/19/2013 @ 9:43PM

Peter Lipson: “Speech is best countered by more speech”

Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 6)

onforb.es/11pwse9

http://t.co/vh3cgAR6hW

http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics
Didymus Judas Thomas, Contributor

Musings on the intersection of Articles, Bias, and Censorship

(The Big 3: A.B.C.)

4/19/2013 @ 9:43PM

A Film Producer, A Cancer Doctor, And Their Critics

guychapman 5 days ago

“All we can tell from the records is that he completed *one* phase 2 trial (out of 60), with no indication of success or failure, and has not published the full results from a single one of these trials.”

Mr. guychapman (also known as Guy Chapman, @SceptiGuy, @vGuyUK), when does this say he must publish human clinical trials by?

Burzynski: Declaration of Helsinki:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-declaration-of-helsinki
“Here’s a really simple question for you: what is Burzynski’s median five-year survival rate compared with standard of care for specific tumour types and stages?”

Mr. guychapman, have you looked here?

Burzynski Clinical Trials (The SEC filings)
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2
“You’ll need to cite a reliable independent source, of course.”

Mr. guychapman, have you looked here?

Burzynski: What happens when a clinical trial is over?
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-what-happens-when-a-clinical-trial-is-over
“You know, a peer-reviewed publication of decent quality.”

Mr. guychapman, have you looked here?

The “National Cancer Institute (NCI) at the National Institutes of Health (NIH)
Cancer Clinical Trials
15. What happens when a clinical trial is over?
http://m.cancer.gov/topics/factsheets/clinical-trials
advises:
“The results of clinical trials are OFTEN published in peer-reviewed scientific journals”
” … WHETHER OR NOT the results are published in a peer-reviewed scientific journal … “

This makes it clear that clinical trial results “are OFTEN” published, but sometimes they are “NOT” published “in a peer-reviewed scientific journal”

“He claims to have treated thousands of patients, this cohort is large enough to perform at least some basic statistical analysis.”

Mr. guychapman, have you looked here?

Burzynski – The Antineoplaston Randomized Japan Phase II Clinical Trial Study
https://stanislawrajmundburzynski.wordpress.com/2013/03/28/burzynski-the-antineoplaston-randomized-japan-phase-ii-clinical-trial-study
JGC2013 4 days ago

“Actually, although Burzynski did submit a design for a phase III trial round about 2009, as of this date not a single patient has been enrolled in this study.”

JGC2013, did you read the Securities and Exchange Commission (SEC) filings?

Burzynski’s Securities and Exchange Commission (SEC) Form 10-Q for the quarterly period ended 5/31/2010 states:
1/13/2009 Company announced Company had reached an agreement with FDA for Company to move forward with pivotal Phase III clinical trial of combination Antineoplaston therapy plus radiation therapy in patients with newly diagnosed, diffuse, intrinsic brainstem gliomas (DBSG)
Agreement was made under FDA’s Special Protocol Assessment procedure, meaning design and planned analysis of Phase III study is acceptable to support regulatory submission seeking new drug approval
2/1/2010 Company entered into agreement with Cycle Solutions, Inc., dba ResearchPoint to initiate and manage pivotal Phase III clinical trial of combination Antineoplastons A10 and AS2-1 plus radiation therapy (RT) in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma
ResearchPoint is currently conducting feasibility assessment
ResearchPoint has secured interest and commitment from number of sites selected
Upon completion of assessment, randomized, international phase III study will commence
Study’s objective is to compare overall survival of children with newly-diagnosed DBSG who receive combination Antineoplastons A10 and AS2-1 plus RT versus RT alone

JGC2013, but then again:

Burzynski: Not every cancer clinical trial taking place in the United States is listed on our NCI clinical trials database
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-not-every-cancer-clinical-trial-taking-place-in-the-united-states-is-listed-on-our-nci-clinical-trials-database
FW 6 days ago

“And yet the American Cancer Society makes exactly the same criticisms of Burzynki that all other critics do:”
http://www.cancer.org/treatment/treatmentsandsideeffects/complementaryandalternativemedicine/pharmacologicalandbiologicaltreatment/antineoplaston-therapy
“No credible evidence.”

FW (also known as @frozenwarning), where is their independent antineoplaston clinical study publications?

rjblaskiewicz 6 days ago

“It’s not a thread about the inherent corruption throughout all of medicine.”

“It’s about some bully/man-child trying to shut up critics.”

Mr. rjblaskiewicz (also known as Bob Blaskiewicz, so, like Forbes was?

A Film Producer, A Cancer Doctor, And Their Critics:
https://stanislawrajmundburzynski.wordpress.com/2013/04/20/a-film-producer-a-cancer-doctor-and-their-critics
Forbes censors Peter Lipson “Speech is best countered by more speech” article comments:
https://stanislawrajmundburzynski.wordpress.com/2013/04/23/forbes-censors-peter-lipson-speech-is-best-countered-by-more-speech-article-comments
Dr. Peter A. Lipson (and / or his Censor(s)) is a Coward: Critiquing “A Film Producer, A Cancer Doctor, And Their Critics:”
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/dr-peter-a-lipson-and-or-his-censors-is-a-coward-critiquing-a-film-producer-a-cancer-doctor-and-their-critics
“You are wrong. But you know this.”
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/critiquing-bob-blaskiewicz-burzynski-cancer-is-serious-business-part-ii
3/26/2013
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/my-critique-of-bob-blaskiewicz-colorado-public-television-pbs-cpt12
Called-out comment

FW 6 days ago

“junkeroo, when you post something rational and intelligible,I will happily respond.”

FW (also known as @frozenwarning), when you post something rational and intelligible, I will happily respond.”
onforb.es/11pwse9

http://t.co/vh3cgAR6hW

http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics
“Instead of cherry picking 20 year old newspaper articles, can I suggest that you try and explain why Burzynski has started 60+ trials, finished one, and never reported the results in peer reviewed journals as any reputable scientist should do?”

FW, have you read these?

Burzynski: What happens when a clinical trial is over?
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-what-happens-when-a-clinical-trial-is-over
The “National Cancer Institute (NCI) at the National Institutes of Health (NIH)
Cancer Clinical Trials
15. What happens when a clinical trial is over?
http://m.cancer.gov/topics/factsheets/clinical-trials
advises:
“The results of clinical trials are OFTEN published in peer-reviewed scientific journals”
” … WHETHER OR NOT the results are published in a peer-reviewed scientific journal … “

This makes it clear that clinical trial results “are OFTEN” published, but sometimes they are “NOT” published “in a peer-reviewed scientific journal”
"As for this mythical Phase 3 trial, which was registered in 2010 and has yet to recruit a single patient, in a tumour that is relatively curable by real medicine."

"I suspect permission to do this was an attempt by the FDA to force Burzynski to do a decent RCT."

"Unfortunately it backfired, because he seems quite happy to never start this trial, instead using it as a marketing tool, in the same way as he is happy to use individual patients."

FW, why was the FDA requiring “radiation
” in the phase 3 clinical trial?

” … only obstacles now are $300 million $s needed to pay for final phase of clinical testing-and FDA requiring children with inoperable brainstem glioma to also undergo radiation
treatment in Phase 3 trials, claiming it would be “unethical” not to do so”

Boris Ogon

“You are right now having a live “debate” in front of more than 10,000 people, … “

3,791 views</strong

Not so much

Waiting for the 10,000

| 4/19/2013 @ 9:43PM

Peter Lipson: “Speech is best countered by more speech”

Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 5)

http://t.co/vh3cgAR6hW

onforb.es/11pwse9

http://t.co/vh3cgAR6hW

http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics
Didymus Judas Thomas, Contributor

Musings on the intersection of Articles, Bias, and Censorship

(The Big 3: A.B.C.)

4/19/2013 @ 9:43PM

A Film Producer, A Cancer Doctor, And Their Critics

FW 6 days ago

“Ah, the usual Burzynski conspiracy theorists are here.”

“As usual, not a single one of the valid criticisms are addressed.”

FW (also known as @frozenwarning)

It’s difficult to address any “allegedly” valid criticisms when Forbes’ censors are blocking (deleting) them

Dr. Peter A. Lipson (and / or his Censor(s)) is a Coward: Critiquing “A Film Producer, A Cancer Doctor, And Their Critics”
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/dr-peter-a-lipson-and-or-his-censors-is-a-coward-critiquing-a-film-producer-a-cancer-doctor-and-their-critics
“Time for this man to be stopped, 40 years is more than long enough to have produced the results of his numerous, badly run trials.”

FW, what year did Burzynski start clinical trials?

Because it sounds like you do NOT know what you’re talking about

Burzynski Clinical Trials (The SEC filings)
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2
“Patients are free to choose whatever treatment they like, but that choice should be informed and sellers of miracle cures must not be allowed to mislead those patients.”

frozenwarning, NO, patients are NOT free to choose whatever treatment they like:

Burzynski: United States Supreme Court:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-united-states-supreme-court
Boris Ogon 6 days ago

“Scamley, however, is able to offer phenylbutyrate (which is all “antineoplastons” actually come down to) and his hopelessly incompetent “gene-targeted therapy” to anyone who’s willing to shell out.”

Mr. Ogon, PHENYLBUTYRATE (PB)is NOT (all “antineoplastons” actually come down to):

Antineoplastons AS2-1 and AS2-5 are DERIVED FROM A10

PHENYLACETYLGLUTAMINATE (PAG or PG) and PHENYLACETATE (PN) are metabolites of PHENYLBUTYRATE (PB) and are constituents of antineoplaston AS2-1

AS2-1=4:1 mixture of PHENYLACETIC ACID (PA) and PHENYLACETYLGLUTAMINE (PAG or PG)

Antineoplaston AS2-5=PHENYLACETYLGLUTAMINE (PAG or PG)

Paul Morgan 5 days ago

“Perhaps you would be so kind as to link to where the 61 registered clinical trials by Burzynski are published?”

“Oh…… you can’t.”

Mr. Morgan:

The “National Cancer Institute (NCI) at the National Institutes of Health (NIH)

Cancer Clinical Trials

15. What happens when a clinical trial is over?

advises:

“The results of clinical trials are OFTEN published in peer-reviewed scientific journals”
” … WHETHER OR NOT the results are published in a peer-reviewed scientific journal … “

http://m.cancer.gov/topics/factsheets/clinical-trials
This makes it clear that clinical trial results “are OFTEN” published, but sometimes they are “NOT” published “in a peer-reviewed scientific journal”

“Let’s just stick to simple, verifiable facts here.”

“Stansislaw Burzynski, the Burzynski Clinic and Burzynski Research Institute have 61 clinical trials registered.”

“The list is available here.”
http://clinicaltrials.gov/ct2/results?term=antineoplaston&Search=Search
“You will note that only ONE trial has ever been completed.”

“By anyone’s standard, that is an appallingly low completion rate.”

“The results have never been published anywhere.”

Mr. Morgan, what YEAR was that “ONE trial” completed?

“No doubt Burzynski and his cronies will continue to spin the line that he’s submitted to journals but they’ve blocked him, when the more likely scenarios are any papers submitted have been rejected due to poor science or there haven’t been any journal submissions.”

“If there have been any journal submissions, there will be a correspondence chain, either emails or paper letters.”

“It would be simple enough for Burzynski to publish them on his website or on a service such as Google Docs.”

Mr. Morgan, have you looked here?

Burzynski Clinical Trials (The SEC filings)
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2
“The single registered Phase 3 trial was never started and – it seems from the Clinic’s own website – seems to have quietly been “forgotten” by them.”

Mr. Morgan, did you know this?

Burzynski: Not every cancer clinical trial taking place in the United States is listed on our NCI clinical trials database
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-not-every-cancer-clinical-trial-taking-place-in-the-united-states-is-listed-on-our-nci-clinical-trials-database
“As for the remaining 59 trials, we can see that 50 have status “unknown”, 2 are “termiinated” and 7 “withdrawn”.”

Mr. Morgan, did you know this?

The “FACT” one should know is that clinicaltrials . gov does NOT contain the same data as the National Cancer Institute (NCI) at the National Institutes of Health (NIH) cancer . gov web-site:

61 TOTAL
1 – Not Yet Recruiting (Open)(Phase 3)
1 – Closed
2 – Terminated (Withdrawn due to slow enrollment)
7 – Withdrawn (This study has been withdrawn prior to enrollment)
10 – Recruiting (Open)
11 – Open (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)

The below 1st link: 10 Active (Open):
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11475951
The below 2nd link: 25 Closed-1st screen / 15 Closed-1 Completed-2nd screen:
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11476036
NONE of the above are “UNKNOWN” per the above 2 National Cancer Institute (NCI) at the National Institutes of Health (NIH) links:

10 – Recruiting (Open)
11 – Open (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)

10=Open
11=1 Not Yet Recruiting / 10 Recruiting
40=Closed
61-TOTAL

“These trials have been running (allegedly) for many years.”

“These are the plain facts of the matter.”

Mr. Morgan, when does the Declaration of Helsinki indicate that the final results of human clinical trials must be published?

Burzynski: Declaration of Helsinki
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-declaration-of-helsinki

“No matter how you try to play it, the simple fact is that there is no published evidence of benefit for antineoplastons, either from Burzynski or anyone else – the Japanese stuff from Kurume is no more than a few case reports.”

Mr. Morgan, is this one of those case reports?

Burzynski – The Antineoplaston Randomized Japan Phase II Clinical Trial Study
https://stanislawrajmundburzynski.wordpress.com/2013/03/28/burzynski-the-antineoplaston-randomized-japan-phase-ii-clinical-trial-study
“If you actually analyse what Burzynski has actually published, it’s a bunch of reports of laboratory work, a mish-mash of case reports and a jumbled-up mixture of preliminary results of mixed-up trials presented as posters at various conferences.”

“Poster presentations prove nothing – they are the lowest form of publication, usually used as a means of presenting preliminary thoughts and ideas, not as proof of efficacy of a therapy.”

“Given that BUrzynski has been researching antineoplastons since he arrived in the USA in 1970 and he first used the term antineoplaston in a publication in 1976 (check out his CV on his website), it’s pretty poor to consider poster presentations of preliminary results as being of any merit whatsoever!”

“Typically, Burzynski supporters will point to the volume of publications but completely fail to grasp the issue of quality.”

“Essentially, Burzynski has been researching antineoplastons for more than 35 years as has failed abjectly to provide any evidence of benefit for their efficacy.”

Mr. Morgan, do you know when the clinical trials were completed?

Burzynski: What happens when a clinical trial is over?
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-what-happens-when-a-clinical-trial-is-over
“Game over.”

Mr. Morgan, really?
http://www.china-burzynski.com

http://www.china-burzynski.com/lczl/bingrengushi_135135.html

http://www.china-burzynski.com/lxwm
Boris Ogon

“You are right now having a live “debate” in front of more than 10,000 people, … “

3,778 views

Not so much

Waiting for the 10,000

| 4/19/2013 @ 9:43PM

Peter Lipson: “Speech is best countered by more speech”