[15] – 1995 (4/3/1995) – Dr. Mario Sznol to Burzynski

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
======================================
[15] – 1995 (4/3/1995) – Dr. Mario Sznol to Burzynski
——————————————————————
Department of Health and Human Services, Public Health Services, National Institutes of Health, National Cancer Institutes

Dear Dr. Burzynski,

Dr. Friedman asked me to respond to your letter of 3/29/1995 regarding the change we have been considering in eligibility criteria for the Memorial Sloan-Kettering and Mayo Clinic phase II studies of antineoplastons

At the investigator’s request, the amendments to modify the eligibility restrictions for size of tumor, number of tumors, and leptomeningeal spread, and to allow entry of patients with KPS of 60, have been approved

These amendments were initiated by the investigators when it became apparent that many good candidates for the study were being excluded because of what were perceived to be overly stringent and unnecessary eligibility restrictions

Approximately a year ago, we wrote to you asking for your concurrence to make similar changes to the protocol

(see enclosed letter)

We have documented that the revised eligibility criteria are consistent with those used in your very own protocols that employ identical or nearly identical treatment regimens

Furthermore, in a review of the 7 patients in the best case series presented to NCI, we have found that perhaps 4 of the 7 patients who apparently had tumor shrinkage would not have been eligible to enter the NCI phase II studies under the original stringent eligibility criteria

(see attached)

These types of patients will now be eligible for study using the revised eligibility criteria proposed by the investigators and recently approved by CTEP

Despite the difficulties in accrual, we are committed to completing the phase II evaluation of the antineoplastons

Our goals remain unchanged, that is, we wish to determine whether the drugs used in the similar manner as you recommend, and in the similar population of patients, will yield results consistent with those in the best case series

As noted above, our careful evaluation of the materials you have provided indicate that the amendments to the eligibility criteria do not deviate from the eligibility criteria and methods you have employed in your experience

We would appreciate the opportunity to review your data, alluded to in your letter, that support the contention that inclusion of theses patients requires a different treatment regimen or is unsafe

In the meantime, we will allow the amendments to stand, since all evidence you have provided to date indicates that these newly eligible patients may have a chance for benefit without undue risk of harm, and are appropriate candidates for evaluation of the drug

We will forward the data on the 1st 5 patients in a separate mailing as you requested

Pg. 2

However, you have asked that we suspend accrual while you review the data

There is no medical or regulatory reason to suspend accrual at this time

Suspending accrual will likely further damage the efforts the investigators have made to increase accrual to the trial

Mario Sznol, M.D.

cc:

Dottie Tisevich
Michael Friedman, M.D.
Mary McCabe
Office of Alternative Medicine

Pg. 3

Antineoplaston Cases

1. Histology partial lobe glioblastoma multiforme
Size 2.3 cm largest diameter
Response CR possible
prior Tx RT, surgery

2. Histology anaplastic astrocytoma stage IV grade 3
Size 3.0 tumor 3.5 tumor and edema
Response CR possible
prior Tx RT

3. Histology infiltrating glioma (astrocytoma or mixed astrocytoma / oligodendroglioma)
Size 4.4
Response good PR, possible CR
prior Tx RT and BUdR; Procarbazine, CCNU, VCR; B-Interferon; DFMO and MGBG

4. Histology well differentiated Stage IV astrocytoma, possible juvenile pilocytic astrocytoma
Size 5.5 X 3.3
Response 40-50% decrease of solid component
prior Tx vitamins and laetrile

5. Histology glioblastoma multiforme
Size 6.5 x 5.0
Response 39% decrease
prior Tx RT

6. Histology glioma consistent with anaplastic astrocytoma, differential: anaplastic astrocytoma or spindle cell variant of oligodendroglioma
Size 5.1 x 2.2
Response CR
prior Tx RT

7. Histology Infiltrating anaplastic astrocytoma
Size 4.0 (L) 4.8 (bifrontal)
Response good response – possible CR
prior Tx RT
——————————————————————

======================================
1995 (4/3/1995) – Dr. Michael A. Friedman to Burzynski [16]
1995 (4/3/1995) – Dr. Mario Sznol to Burzynski [21] (3 pgs.)
1995 (3/29/1995) – Burzynski to Dr. Michael A. Friedman
======================================

Critiquing David H. Gorski, MD, PhD, FACS www.sciencebasedmedicine.org/editorial-staff/david-h-gorski-md-phd-managing-editor/

Critiquing David H. Gorski, MD, PhD, FACS http://www.sciencebasedmedicine.org/editorial-staff/david-h-gorski-md-phd-managing-editor/

“Our only goal is to promote high standards of science in medicine”
——————————————————————
http://www.sciencebasedmedicine.org/editorial-staff/
——————————————————————
So proclaims Science Based Medicine . org

6/10/2013 Gorski published:
======================================
BBC Panorama investigates Stanislaw Burzynski
——————————————————————
http://www.sciencebasedmedicine.org/bbc-panorama-investigates-stanislaw-burzynski/
======================================
“Burzynski hasn’t published anything other than case reports, tiny case series, and unconvincing studies, mostly (at least over the last decade or so) in crappy journals not even indexed on PubMed”
——————————————————————
Gorski’s above statement makes me wonder if PhD’s are handed out to any hack that requests one

Burzynski has published at least 4 publications which list all of the patients and information like:
======================================
[2] 16. 2003
(Pgs. 95-96) data charts
(Pg. 95)

Case
Sex
Age
Date of initial diagnosis
Tumor histology
Tumour location
Tumour size
Previous therapies
Karnofsky performance status
KPS baseline
Date of recurrence
(Pg. 96)
Start date
Stop date
Days on treatment
Dosage
Response
Status / date of death
Progression date
Survival time (weeks) from start
Time (weeks) to progression
Last contact

======================================
[9] 17. 2004
(Pgs. 316 + 318-321) data charts
(Pg. 316)

Gender
Age
Tumour histology
Tumour size (total of measured lesions)
Previous therapies
Karnofsky performance status
(Pg. 318)
Case
Age at admission
Sex
Ethnicity
Date of initial diagnosis
Pathology code
Visual Pathway Glioma (VPG)
Karnofsky baseline
Previous treatment
Multicentric tumour location
(Pg. 319)
” ”
(Pg. 320)
Case
Start date
Stop date
Days on treatment
Average dosage (IV treatment / PO treatment)
(Pg. 321)
Case
Response
Maximum response date
Time to maximum response (months)
Radiological PD as of 1/03/04
Progression Free Survival (PFS) (year)
Status
Karnofsky Performance Status (KPS) baseline
Karnofsky Performance Status (KPS) follow-up
Reason for withdrawal
Survival time from diagnosis (years)

======================================
[10] 18. 6/2005
(Pgs. 169 + 171
..172) data charts
(Pg. 169)

Gender
Tumor type
Tumor spread
Previous therapies
Age
Karnofsky performance status
(Pg. 171)
Case
Protocol
Gender
Age at Admission (years)
Ethnicity
Date of Initial Diagnosis
Tumor Type
Tumor Dissemination
Karnofsky Performance Status (KPS) Baseline
Previous treatment
(Pg. 172)
Case
Start Date
Stop Date
Days on Treatment
Average Dosage g/kg/d (A10 / AS2-1)

Case
Response
Radiological PD
Progression Free Survival (PFS) (month)
Status
Karnofsky Performance Status (KPS) Baseline
Karnofsky Performance Status (KPS) Follow-up
Reason for Withdrawal
Overall Survival from Diagnosis (OSD) (month)
Overall Survival from Start (OSS) (month)

======================================
[12] 19. 3/2006
(Pgs. 42-45) data charts
(Pg. 42)

Gender
Age
Tumor history
Tumor size at baseline
Previous therapies
Karnofsky Performance Status
(Pg. 43)
Case
Protocol
Sex
Age (years)
Date of Initial Diagnosis
Tumor Type
Tumor Dissemination
Recurrence
Karnofsky Performance Status (KPS) Baseline
Previous Treatment
(Pg. 44)
Case
Start Date
Stop Date
Days On
Average Dosage g/kg/d (A10 / AS2-1)
(Pg. 45)
Case
Response
Radiological PD
Progression Free Survival (PFS) (months)
Status
Karnofsky Performance Status (KPS) Baseline
Karnofsky Performance Status (KPS) Follow-Up
Reason for Withdrawal
Overall Survival from Diagnosis (OSD) (month)
Overall Survival from Start of antineoplaston(OST) (month)

======================================
Maybe Gorski should try “deconstructing” some of these, especially the ones where patients did NOT have chemotherapy or radiation therapy

I’ve even provided a handy reference list

But by George, I’m George Dubya dubious that Gorski can handle it, given his track record
� � � � � � � � � � � � � � � � �
[18] 12/2009 (Pg. 923)
1 – Special Exception (SE)
——————————————————————
[3] 1. 3/2004 (Pg. 52)
10 – subgroup
——————————————————————
[3] 1. 3/2004 (Pg. 55)
10 – Japan
——————————————————————
[11] 7. 7/2005 (Pg. 300)
10 – children
——————————————————————
[2] 16. 2003 (Pg. 98)
11 – Special Exception (SE)
——————————————————————
[7] 4. 10/2004 (Pg. 427)
11 – children
4 – children Study (ST)
7 – children Special Exception (SE)
——————————————————————
[1] 1. 10/2003 (Pg. 358)
12 – children
——————————————————————
[2] 16. 2003 (Pg. 91)
1st 12 – Study (ST)
——————————————————————
[4] 4. 9/2004 (Pg. 257)
12
——————————————————————
[9] 17. 2004 (Pg. 316)
1st 12 – children
——————————————————————
[15] 10. 6/2008 (Pg. 450)
1st 12 – children
——————————————————————
[10] 18. 6/2005 (Pgs. 169 + 176)
13 – children
——————————————————————
[8] 5. 10/2004 (Pg. 428)
17
——————————————————————
[20] 14. 6/2010 (Pg. ii95)
17
——————————————————————
[12] 19. 3/2006 (Pgs. 40-41 + 46)
18
——————————————————————
[3] 1. 3/2004 (Pg. 50)
19 – children
——————————————————————
[3] 1. 3/2004 (Pg. 55)
19 – Japan
——————————————————————
[14] 8. 10/2006 (Pg. 466)
19
——————————————————————
[16] 10/2008 (Pg. 821)
20
——————————————————————
[17] 12/2008 (Pg. 1067)
20
——————————————————————
[21] 15. 11/2010 (Pg. iv72)
20
——————————————————————
[5] 2. 10/2004 (Pg. 384)
22
——————————————————————
[6] 3. 10/2004 (Pg. 386)
31 – Special Exception (SE)
——————————————————————
[19] 13. 12/2009 (Pg. 951)
40
——————————————————————
[19] 13. 12/2009 (Pg. 951)
52 – Special Exception SE)
——————————————————————
[3] 1. 3/2004 (Pg. 55)
56 – Japan
——————————————————————
[6] 3. 10/2004 (Pg. 386)
60
——————————————————————
[3] 1. 3/2004 (Pg. 52)
62
——————————————————————
[3] 1. 3/2004 (Pg. 53)
80
——————————————————————
[13] 2006
30 (Pg. 173)
335 – children (Pg. 174)
1652 – adults (Pg. 174)
� � � � � � � � � � � � � � � � �
[18] 12/2009 (Pg. 923)
1 – evaluable Special Exception (SE)
——————————————————————
[2] 16. 2003 (Pg. 91)
1st 10 – evaluable Study (ST)
——————————————————————
[3] 1. 3/2004 (Pg. 52)
10 – evaluable subgroup
——————————————————————
[3] 1. 3/2004 (Pg. 55)
10 – evaluable Japan
——————————————————————
[11] 7. 7/2005 (Pg. 300)
10 – evaluable children
——————————————————————
[2] 16. 2003 (Pg. 98)
11 – evaluable Special Exception (SE)
——————————————————————
[7] 4. 10/2004 (Pg. 427)
11 – evaluable children
4 – evaluable children Study (ST)
7 – evaluable children Special Exception (SE)
——————————————————————
[1] 1. 10/2003 (Pg. 358)
12 – evaluable children
——————————————————————
[9] 17. 2004 (Pg. 316)
1st 12 – evaluable children
——————————————————————
[15] 10. 6/2008 (Pg. 450)
1st 12 – evaluable children
——————————————————————
[10] 18. 6/2005 (Pgs. 169 + 176)
13 – evaluable children
——————————————————————
[21] 15. 11/2010 (Pg. iv72)
13 – evaluable
——————————————————————
[8] 5. 10/2004 (Pg. 428)
17 – evaluable
——————————————————————
[20] 14. 6/2010 (Pg. ii95)
17 – evaluable
——————————————————————
[3] 1. 3/2004 (Pg. 51)
18 – evaluable children
——————————————————————
[12] 19. 3/2006 (Pgs. 40-41 + 46)
18 – evaluable
——————————————————————
[3] 1. 3/2004 (Pg. 55)
19 – evaluable Japan
——————————————————————
[14] 8. 10/2006 (Pg. 466)
19 – evaluable
——————————————————————
[16] 10/2008 (Pg. 821)
20 – evaluable
——————————————————————
[17] 12/2008 (Pg. 1067)
20 – evaluable
——————————————————————
[5] 2. 10/2004 (Pg. 384)
22 – evaluable
——————————————————————
[6] 3. 10/2004 (Pg. 386)
31 – evaluable Special Exception (SE)
——————————————————————
[19] 13. 12/2009 (Pg. 951)
52 – evaluable Special Exception SE)
——————————————————————
[3] 1. 3/2004 (Pg. 55)
56 – evaluable Japan
——————————————————————
[6] 3. 10/2004 (Pg. 386)
60 – evaluable
——————————————————————
[3] 1. 3/2004 (Pg. 52)
62 – evaluable
——————————————————————
[3] 1. 3/2004 (Pg. 53)
80 – evaluable
——————————————————————
[13] 2006
30 – evaluable (Pg. 173)
335 – children (Pg. 174)
1652 – adults (Pg. 174)
� � � � � � � � � � � � � � � � �
[1] 1. 10/2003 (Pg. 358)
escalating doses of ANP intravenous injections (IV) and subsequently capsules (po)
——————————————————————
[2] 16. 2003 (Pg. 91)
Patients received escalating doses of antineoplaston A10 and AS2-1 by intravenous bolus injections
——————————————————————
[2] 16. 2003 (Pg. 93)
Antineoplaston therapy was administered in gradually escalating doses by intermittent bolus injections 6 times a day using a portable Provider 6000 dual-channel pump (Abbott Laboratories, North Chicago, IL, USA)
——————————————————————
[5] 2. 10/2004 (Pg. 384)
ANP was given in escalating doses by intravenous bolus injections
——————————————————————
[9] 17. 2004 (Pg. 317)
Gradually escalating doses were administered by intermittent bolus injections 6 times a day using a portable Provider 6000 dual channel pump (Abbott Laboratories, North Chicago, IL, USA)
——————————————————————
[12] 19. 3/2006 (Pg. 40)
Antineoplastons A10 (A10I) and AS2-1 injections, were given in escalating doses by intravenous injections
——————————————————————
[20] 14. 6/2010 (Pg. ii95)
Patients received escalating doses of intravenous A10 and AS2-1 6 times daily
12 or more weeks – ANP
or
at least 4 weeks – ANP but developed progressive disease (PD)
——————————————————————
[21] 15. 11/2010 (Pg. iv72)
Patients received escalating doses of intravenous ANP 6 times daily
� � � � � � � � � � � � � � � � �
[2] 16. 2003 (Pg. 93)
Dose escalation was necessary to prevent peritumoral oedema
——————————————————————
[9] 17. 2004 (Pg. 317)
Gradual dose escalation was necessary to prevent peritumoral oedema
——————————————————————
[12] 19. 3/2006 (Pg. 44)
ANP was given by intravenous injections in escalating doses to prevent peritumoral oedema
� � � � � � � � � � � � � � � � �
[2] 16. 2003 (Pg. 93)
Treatment consisted of daily intravenous injections of antineoplaston A10 (300 mg / mL) and AS2-1 (80 mg / mL) through a Broviac or equivalent catheter
——————————————————————
[4] 4. 9/2004 (Pgs. 257-260)
he was admitted for administration of intravenous antineoplastons A10 and AS2-1 through a subclavian venous catheter by intermittent bolus injections 6 times per day using a portable pump
——————————————————————
[7] 4. 10/2004 (Pg. 427)
intravenous injection of ANP
——————————————————————
[8] 5. 10/2004 (Pg. 428)
intravenous infusions of ANP
——————————————————————
[9] 17. 2004 (Pg. 317)
300 mg / ML – Daily intravenous injections of A10
——————————————————————
[9] 17. 2004 (Pg. 317)
80 mg / ML – Daily intravenous injections of AS2-1
——————————————————————
[9] 17. 2004 (Pg. 317)
administered through a subclavian venous catheter
——————————————————————
[9] 17. 2004 (Pg. 315)
ANP intravenously initially and subsequently orally
——————————————————————
[10] 18. 6/2005 (Pg. 169)
intravenous infusions of 2 formulations of ANP, A10 and AS2-1
——————————————————————
[10] 18. 6/2005 (Pg. 170)
IV ANP
——————————————————————
[11] 7. 7/2005 (Pg. 300)
ANP was given intravenously daily through a subclavian venous catheter and double channel infusion pump
——————————————————————
[12] 19. 3/2006 (Pg. 42)
Treatment involved daily intravenous injections of A10I and AS2-1
——————————————————————
[12] 19. 3/2006 (Pg. 42)
The injections were administered every 4 hours through a subclavian venous catheter via a dual-channel infusion pump
——————————————————————
[14] 8. 10/2006 (Pg. 466)

ANP was given intravenously daily through a subclavian venous catheter and a double-channel infusion pump
——————————————————————
[15] 10. 6/2008 (Pg. 450)
Treatment consisted of intravenous infusions of antineoplastons (ANP) A10 and AS2-1
——————————————————————
[16] 10/2008 (Pg. 821)
ANP was administered intravenously daily through a subclavian central venous catheter by a double-channel infusion pump
——————————————————————
[17] 12/2008 (Pg. 1067)
ANP was administered intravenously daily through a subclavian venous catheter via a double-channel infusion pump
——————————————————————
[18] 12/2009 (Pg. 923)
The patient received intravenous injections of ANP every 4 hours through a subclavian central venous catheter via a double channel infusion pump followed by PO ANP only
——————————————————————
[18] 12/2009 (Pg. 923)
6/8/2000 – PO ANP
——————————————————————
[18] 12/2009 (Pg. 923)
IV ANP
——————————————————————
[19] 13. 12/2009 (Pg. 951)
ANP was administered daily through a subclavian venous catheter via a double channel infusion pump
� � � � � � � � � � � � � � � � �
[9] 17. 2004 (Pg. 317)
Intravenous injections were discontinued after determination of CR, PR, or stable disease (SD)
——————————————————————
[9] 17. 2004 (Pg. 317)
After discontinuation of injections, the patients continued A10 and AS2-1 in 0.5g capsules
——————————————————————
[18] 12/2009 (Pg. 923)
7/8/2004 – discontinued
——————————————————————
[18] 12/2009 (Pg. 923)
2/1999 – CR
� � � � � � � � � � � � � � � � �
[5] 2. 10/2004 (Pg. 384)
4.3 months – median duration of administration
——————————————————————
[21] 15. 11/2010 (Pg. iv72)
4.4 months – median duration of treatment
——————————————————————
[14] 8. 10/2006 (Pg. 466)
4 1/2 months – median duration of i.v. ANP
——————————————————————
[12] 19. 3/2006 (Pg. 40)
5 months – median duration of antineoplaston administration
——————————————————————
[8] 5. 10/2004 (Pg. 428)
5.2 months – administered median
——————————————————————
[19] 13. 12/2009 (Pg. 951)
5.4 months – median duration of treatment (ST)
——————————————————————
[19] 13. 12/2009 (Pg. 951)
5.6 months – median duration of treatment (SE)
——————————————————————
[7] 4. 10/2004 (Pg. 427)

5.7 months – average duration of ANP
——————————————————————
[16] 10/2008 (Pg. 821)
5.7 months – median duration of treatment
——————————————————————
[2] 16. 2003 (Pgs. 91 + 96)
6 months – median duration of treatment
——————————————————————
[17] 12/2008 (Pg. 1067)
6.5 months – median duration of treatment
——————————————————————
[1] 1. 10/2003 (Pg. 358)

9.5 months – median duration of IV ANP
——————————————————————
[11] 7. 7/2005 (Pg. 300)
9 1/2 months – median duration of administration
——————————————————————
[9] 17. 2004 (Pgs. 315 + 320)
16 months (1 year 4 months) average duration of intravenous ANP
——————————————————————
[15] 10. 6/2008 (Pg. 450)
16.5 months – median
——————————————————————
[9] 17. 2004 (Pg. 320)
19 months – average duration of oral ANP
——————————————————————
[10] 18. 6/2005 (Pgs. 168 + 170)
20 months (1 year 8 months) administered average duration
� � � � � � � � � � � � � � � � �
[1] 1. 10/2003 (Pg. 358)
28.6 months – median duration of po ANP
After obtaining at least minor response (SD), the treatment continued with po ANP
——————————————————————
[4] 4. 9/2004 (Pg. 257)
655 consecutive days – administration of antineoplastons A10 and AS2-1 with the exception of a few short interruptions
� � � � � � � � � � � � � � � � �
[16] 10/2008 (Pg. 821)
5.69 g/kg/day – median average dosage of A10
——————————————————————
[17] 12/2008 (Pg. 1067)
5.8 g/kg/day – median average dosages of A10
——————————————————————
[21] 15. 11/2010 (Pg. iv72)
6.0 g/kg/day – median average dosages of A10
——————————————————————
[5] 2. 10/2004 (Pg. 384)
6.37 g/kg/day – average dosage of Antineoplaston A10
——————————————————————
[1] 1. 10/2003 (Pg. 358)
7.95 g/kg/day – average dosage of A10
——————————————————————
[9] 17. 2004 (Pgs. 315 + 320)
7.95 g/kg/day – average dosage of A10
——————————————————————
[15] 10. 6/2008 (Pg. 450)
8.36 g/kg/day – average dosage of A10
——————————————————————
[19] 13. 12/2009 (Pg. 951)
9.0 g/kg/day – median of average dosages of A10 (ST)
——————————————————————
[14] 8. 10/2006 (Pg. 466)
9.2 g/kg/day – average dosage of A10
——————————————————————
[12] 19. 3/2006 (Pg. 40)
9.22 g/kg/day – average dosage of A10I
——————————————————————
[8] 5. 10/2004 (Pg. 428)
9.4 g/kg/d – median of average dosages of A10
——————————————————————
[19] 13. 12/2009 (Pg. 951)
9.4 g/kg/day – median of average dosages of A10 (SE)
——————————————————————
[10] 18. 6/2005 (Pgs. 168 + 170)
10.30 g/kg/day – average dosage of A10
——————————————————————
[7] 4. 10/2004 (Pg. 427)
10.6 g/kg/d – median of average dosages of A10
——————————————————————
[2] 16. 2003 (Pg. 91)
11.3 g/kg/day – average dosage of A10
——————————————————————
[11] 7. 7/2005 (Pg. 300)
12.16 g/kg/day – average dosage of A10
======================================
[2] 16. 2003 (Pg. 96)
5.3-16.1 g/kg/day – dosage of A10
� � � � � � � � � � � � � � � � �
[1] 1. 10/2003 (Pg. 358)
0.28 g/kg/d – average dosage of A10 and AS2-1
After obtaining at least minor response (SD), the treatment continued with po ANP
——————————————————————
[9] 17. 2004 (Pg. 320)
0.28 g/kg/day – average dosage of A10 and AS2-1
� � � � � � � � � � � � � � � � �
[4] 4. 9/2004 (Pg. 257)
8.15 g/kg/d – maximum dosage of A10
� � � � � � � � � � � � � � � � �
[2] 16. 2003 (Pg. 96)
11.3 g/kg/day – average maximum dosage of A10
——————————————————————
[12] 19. 3/2006 (Pg. 42)
13.37 g/kg/day – maximum dosage of A10I (SD = 7.36 g/kg/day)
� � � � � � � � � � � � � � � � �
[2] 16. 2003 (Pg. 93)
20 g/kg/day – highest tolerated or effective dosage of A10 not exceeding
� � � � � � � � � � � � � � � � �
[2] 16. 2003 (Pg. 96)
331.4 kg – maximum total dose of A10
� � � � � � � � � � � � � � � � �
[5] 2. 10/2004 (Pg. 384)
0.24 g/kg/day – average dosage of Antineoplaston AS2-1
——————————————————————
[17] 12/2008 (Pg. 1067)
0.24 g/kg/day – median average dosages of AS2-1
——————————————————————
[16] 10/2008 (Pg. 821)
0.28 g/kg/day – median average dosage of AS2-1
——————————————————————
[19] 13. 12/2009 (Pg. 951)
0.3 g/kg/day – median of average dosages of AS2-1 (ST and SE)
——————————————————————
[21] 15. 11/2010 (Pg. iv72)
0.3 g/kg/day – median average dosages of AS2-1
——————————————————————
[12] 19. 3/2006 (Pg. 40)
0.31 g/kg/day – average dosage of AS2-1
——————————————————————
[14] 8. 10/2006 (Pg. 466)
0.32 g/kg/day – average dosage of AS2-1
——————————————————————
[9] 17. 2004 (Pgs. 315 + 320)
0.33 g/kg/day – average dosage of AS2-1
——————————————————————
[1] 1. 10/2003 (Pg. 358)
0.34 g/kg/d – average dosage of AS2-1
——————————————————————
[15] 10. 6/2008 (Pg. 450)
0.37 g/kg/day – average dosage of AS2-1
——————————————————————
[10] 18. 6/2005 (Pgs. 168 + 170)
0.38 g/kg/day – average dosage of AS2-1
——————————————————————
[2] 16. 2003 (Pg. 91)
0.4 g/kg/day – average dosage of AS2-1
——————————————————————
[7] 4. 10/2004 (Pg. 427)
0.4 g/kg/d – median of average dosages of AS2-1
——————————————————————
[8] 5. 10/2004 (Pg. 428)
0.4 g/kg/d – median of average dosages of AS2-1
——————————————————————
[11] 7. 7/2005 (Pg. 300)
0.41 g/kg/day – average dosage of AS2-1
� � � � � � � � � � � � � � � � �
[2] 16. 2003 (Pg. 96)
0.2-0.6 g/kg/day – dosage of AS2-1
� � � � � � � � � � � � � � � � �
[4] 4. 9/2004 (Pg. 257)
0.35 g/kg/d – maximum dosage of
AS2-1
� � � � � � � � � � � � � � � � �
[2] 16. 2003 (Pg. 96)
0.4 g/kg/day – average maximum dosage of AS2-1
� � � � � � � � � � � � � � � � �
[2] 16. 2003 (Pg. 93)
0.4 g/kg/day – highest tolerated or effective dosage of AS2-1 not exceeding
� � � � � � � � � � � � � � � � �
[12] 19. 3/2006 (Pg. 42)
0.49 g/kg/day – maximum dosage of AS2-1 (SD = 0.26 g/kg/day)
� � � � � � � � � � � � � � � � �
[2] 16. 2003 (Pg. 96)
23.9 kg – maximum total dose of AS2-1
� � � � � � � � � � � � � � � � �
[1] 1. 10/2003 (Pg. 358)
1 / 9% – nonevaluable due to only 4 weeks of treatment and lack of follow-up scans
This patient died while on treatment due to a brain infarct and was counted as a treatment failure
——————————————————————
[7] 4. 10/2004 (Pg. 427)
1 – nonevaluable
——————————————————————
[9] 17. 2004
1 – nonevaluable due to only receiving 4 weeks of ANP and no follow-up scans
This patient died while receiving ANP due to a nonhemorrhaging brain infarction and was considered a treatment failure (Pg. 320)
(only 4 weeks after initiation of ANP Pg. 321)
(There was no evidence that these were treatment related deaths Pg. 321)
——————————————————————
[2] 16. 2003 (Pg. 96)
Patient 2 unable to be evaluated because didn’t have follow-up MRI to determine response
——————————————————————
[2] 16. 2003 (Pg. 96)
Patient 11 unable to be evaluated because died of intratumoral hemorrhage and her duration of treatment was too short to short for evaluation of response
——————————————————————
[8] 5. 10/2004 (Pg. 428)
2 – nonevaluable due to lack of follow-up scans
——————————————————————
[7] 4. 10/2004 (Pg. 427)
3 Special Exception (SE) – nonevaluable
——————————————————————
[21] 15. 11/2010 (Pg. iv72)
7 – couldn’t be evaluated due to an inadequate duration of treatment and lack of follow-up magnetic resonance imaging (MRI) scans
——————————————————————
[19] 13. 12/2009 (Pg. 951)
12 – not evaluable due to too short a duration of treatment and lack of follow-up MRIs
� � � � � � � � � � � � � � � � �
[2] 16. 2003 (Pg. 97)
4 – died from the tumour
4 – died from aspiration pneumonia
2 – intratumoral bleeding
——————————————————————
[7] 4. 10/2004 (Pg. 427)
One CR patient developed recurrence after premature discontinuation of ANP and obtained a 2nd CR after ANP was restarted
This patient who initially had multiple metastases to the brain and spinal cord died due to aspiration pneumonia and was confirmed by autopsy as disease free
——————————————————————
[9] 17. 2004
1 patient who had stable disease discontinued ANP against medical advice and died 4.5 years later (Pgs. 315 + 320)
(There was no evidence that these were treatment related deaths Pg. 321)
——————————————————————
[10] 18. 6/2005
1 patient passed away after 6 years, 10 months from the start of the treatment (3 years after discontinuation of ANP)
The cause of death was recurrent pneumonia, possibly due (Pg. 170)
to chronic immunosuppression from chemotherapy administered prior to ANP (patient 1) (Pg. 172)
——————————————————————
[12] 19. 3/2006 (Pg. 45)
The deaths of 12 patients were most likely tumor related
——————————————————————
[12] 19. 3/2006 (Pg. 45)
There was a single death due to a pulmonary embolism
——————————————————————
[12] 19. 3/2006 (Pg. 45)
2 cases of death possibly resulting from aspiration pneumonia
� � � � � � � � � � � � � � � � �
[2] 16. 2003 (Pg. 97)
The 2 surviving patients weren’t previously treated with chemotherapy and radiation therapy and didn’t develop pneumonia or intratumoral bleeding
——————————————————————
[10] 18. 6/2005 (Pg. 169)
6 hadn’t received prior chemotherapy or radiation
——————————————————————
[10] 18. 6/2005 (Pg. 175)
6 long-term
——————————————————————
[12] 19. 3/2006 (Pgs. 40-41)
6 – didn’t have radiation therapy or chemotherapy
——————————————————————
[16] 10/2008 (Pg. 821)
No patients received radiation or chemotherapy before starting ANP, but 6 patients underwent surgery and 14 had biopsy only
——————————————————————
[18] 12/2009 (Pg. 923)
The tumor was inoperable
� � � � � � � � � � � � � � � � �
[2] 16. 2003
Patient 3 (Pg. 95)
Patient 8 (Pg. 95)
Case 10 (Pgs. 96-97)
——————————————————————
[3] 1. 3/2004
Case Study, Patient 1 (Pgs. 50-51)
Case Study, Patient 2 (Pgs. 51-52)
Case Study, Patient 3 (Pgs. 53-54)
Case Study, Patient 4 (Pg. 54)
Case Study, Patient 5 (Pg. 55)
——————————————————————
[9] 17. 2004
Case 8 (Pgs. 321-322)
Case 10 (Pgs. 321 + 323)
——————————————————————
[10] 18. 6/2005 (Pgs. 172-173)
Patient 4
——————————————————————
[10] 18. 6/2005 (Pgs. 173-174)
Patient 11
——————————————————————
[12] 19. 3/2006 (Pgs. 45-46)
Case Report Patient 12
� � � � � � � � � � � � � � � � �
[2] 16. 2003 (Pg. 94)
Trial design – Fleming
——————————————————————
[9] 17. 2004 (Pg. 317)
Trial design – Fleming
� � � � � � � � � � � � � � � � �
======================================
Gorski has claimed:
======================================
6/7/2013 “Unlike Mr. Merola, I am indeed very concerned with getting my facts correct”
——————————————————————
http://scienceblogs.com/insolence/2013/06/07/i-want-my-anp/
======================================
6/5/2013 “ … I do know cancer science”
——————————————————————
http://scienceblogs.com/insolence/2013/06/05/odds-and-ends-about-burzynski-clinic/
======================================
11/2/2012 “Personally, having pored over Burzynski’s publications … “
——————————————————————
http://scienceblogs.com/insolence/2012/11/02/stanislaw-burzynski-fails-to-save-another-patient/
======================================
5/8/2013 “I’ve searched Burzynski’s publications … “
——————————————————————
http://scienceblogs.com/insolence/2013/05/08/eric-merola-and-stanislaw-burzynskis-secret-weapon-against-the-skeptics-fabio-lanzoni-part-2/
======================================
☆AnthonyJeselnik☆
🚫GorskonOrac🚫
You tweeted 12:44pm-3/30/13📄

——————————————————————
David Gorski (@gorskon) tweeted at 12:44pm – 30 Mar 13:

——————————————————————
Defend your tweet😅
#Burzynski—
(@FauxSkeptic) May 23, 2013

——————————————————————
David Gorski (@gorskon)
5/23/13, 9:32 AM

——————————————————————
@FauxSkeptic No need to defend my Tweet. The defense is in the link.
http://www.sciencebasedmedicine.org/index.php/stanislaw-burzynski-bad-medicine-a-bad-movie
——————————————————————
NO, Dr. Gorski, you have NOT “deconstructed his “evidence” in depth before”
Burzynski: Cancer Is Serious Business (Part I) consists of the documentary; as well as the documents on the movie web-site, which you have NOT “deconstructed … in depth before”

(What Gorski did is termed: “cherry-picking”)

Maybe #ScienceBasedMedicine needs to change this
——————————————————————
“Our only goal is to promote high standards of science in medicine”
======================================
� � � � � � � � � � � � � � � � �
References:
� � � � � � � � � � � � � � � � �
http://www.burzynskiclinic.com/scientific-publications.html
� � � � � � � � � � � � � � � � �
[1] 1. 10/2003 (Pg. 358)
——————————————————————
Interim Reports on Clinial Trials:
NEURO-ONCOLOGY
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
======================================
[2] 16. 2003 (Pgs. 91-101)
——————————————————————
Interim Reports on Clinial Trials
BT-11 – BRAIN STEM GLIOMA
Special exception (SE) to BT-11
DRUGS IN R&D
Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma:
a preliminary report
recurrent diffuse intrinsic brain stem glioma
Drugs in R and D
(Drugs in Research and Development)
http://www.ncbi.nlm.nih.gov/pubmed/12718563
Drugs In R and D / Drugs in Research and Development:
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs R D. 2003;4(2):91-101
http://www.burzynskiclinic.com/images/stories/Publications/960.pdf
Drugs in R&D 2003;4:91-101
======================================
[3] 1. 3/2004 (Pgs. 47-58)
——————————————————————
Review Articles on Clinical Trials:
INTEGRATIVE CANCER THERAPIES
The Present State of Antineoplaston Research
http://www.burzynskiclinic.com/images/stories/Publications/994.pdf
Integrative Cancer Therapies 2004;3:47-58
Volume 3, No. 1, March 2004
DOI: 10.1177/1534735-403261964
======================================
[4] 4. 9/2004 (Pgs. 257-261)
——————————————————————
Case Reports:
INTEGRATIVE CANCER THERAPIES
Special exception (SE) to BT-11 BRAIN STEM GLIOMA
Long-term survival and complete response of a patient with recurrent diffuse intrinsic brain stem glioblastoma multiforme
http://www.burzynskiclinic.com/images/stories/Publications/1145.pdf
Integrative Cancer Therapies 2004;3:257-261
Volume 3, Number 3 September 2004
======================================
[5] 2. 10/2004 (Pg. 384)
——————————————————————
Interim Reports on Clinial Trials:
NEURO-ONCOLOGY
BT-20 Patients With GLIOBLASTOMA MULTIFORME (GBM)
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
======================================
[6] 3. 10/2004 (Pg. 386)
——————————————————————
Interim Reports on Clinial Trials:
(DBSG) (Study (ST) and Special Exception (SE))
NEURO-ONCOLOGY
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
======================================
[7] 4. 10/2004 (Pg. 427)
——————————————————————
Interim Reports on Clinial Trials:
(AT/RT of CNS) (Study (ST) and Special Exception (SE))
NEURO-ONCOLOGY
BT-14 CHILDREN WITH RHABDOID TUMOR OF THE CENTRAL NERVOUS SYSTEM
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
======================================
[8] 5. 10/2004 (Pg. 428)
——————————————————————
Interim Reports on Clinial Trials:
NEURO-ONCOLOGY
BT-12 CHILDREN WITH PRIMITIVE NEUROECTODERMAL TUMORS (PNET)
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
======================================
[9] 17. 2004 (Pgs. 315-326)
——————————————————————
Interim Reports on Clinial Trials:
DRUGS IN R&D
Drugs in R and D
(Drugs in Research and Development)
Pg. 317
BT-13 – children with low-grade astrocytoma
BT-23 – children with visual pathway gliomas
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
======================================
[10] 18. 6/2005 (Pgs. 168-177)
——————————————————————
Interim Reports on Clinial Trials:
INTEGRATIVE CANCER THERAPIES
BT-12 children with PRIMITIVE NEUROECTODERMAL TUMORS (PNET)
CAN-01 (CAN-1) PATIENTS WITH REFRACTORY MALIGNANCIES
Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with Antineoplastons A10 and AS2-1
http://www.ncbi.nlm.nih.gov/pubmed/15911929
Integrative Cancer Therapies 2005;4(2):168-177
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
Integr Cancer Ther. 2005 Jun;4(2):168-77
http://www.burzynskiclinic.com/images/stories/Publications/1220.pdf
DOI: 10.1177/1534735405276835
http://m.ict.sagepub.com/content/4/2/168.long?view=long&pmid=15911929
Volume 4 Number 2 June 2005
======================================
[11] 7. 7/2005 (Pg. 300)
——————————————————————
Interim Reports on Clinial Trials:
BT-11 BRAIN STEM GLIOMA
Targeted therapy with ANP in children less than 4 years old with inoperable brain stem gliomas. Neuro-Oncology. 2005; 7:300
http://www.burzynskiclinic.com/images/stories/Publications/1224.pdf
Volume 7 Issue 3 July 2005
Abstracts from the World Federation of Neuro-Oncology Meeting
======================================
[12] 19. 3/2006 (Pgs. 40-47)
——————————————————————
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
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
======================================
[13] 2006 (Pgs. 167-168)
——————————————————————
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf
======================================
[14] 8. 10/2006 (Pg. 466)
——————————————————————
Interim Reports on Clinial Trials:
BT-11 BRAIN STEM GLIOMA
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)
======================================
[15] 10. 6/2008 (Pg. 450)
——————————————————————
NEURO-ONCOLOGY
Interim Reports on Clinical Trials:
(OPG)
BT-23 – CHILDREN WITH VISUAL PATHWAY GLIOMA
Phase II study of antineoplastons A10 and AS2-1 (ANP) in children with optic pathway glioma:
A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/7287.pdf
Neuro-Oncology 2008; 10:450
Volume 10 Issue 3 June 2008
======================================
[16] 10/2008 (Pg. 821)
——————————————————————
NEURO-ONCOLOGY
Phase II study of antineoplastons A10 and AS2-1 (ANP) in patients with newly diagnosed anaplastic astrocytoma:
A preliminary report
http://www.burzynskiclinic.com/images/stories/Publications/7853.pdf
Neuro-Oncology 2008; 10:821
Volume 10 Issue 5 October 2008
======================================
[17] 12/2008 (Pg. 1067)
——————————————————————
NEURO-ONCOLOGY
Phase II study of antineoplastons A10 and AS2-1 infusions (ANP) in patients with recurrent anaplastic astrocytoma
http://www.burzynskiclinic.com/images/stories/Publications/7898.pdf
Neuro-Oncology 2008; 10:1067
Volume 10 Issue 6 December 2008
======================================
[18] 12/2009 (Pg. 923)
——————————————————————
Case Reports:
NEURO-ONCOLOGY
Over a 10-year survival and complete response of a patient with diffuse intrinsic brainstem glioma (DBSG) treated with antineoplastons (ANP)
http://www.burzynskiclinic.com/images/stories/Publications/8638.pdf
Neuro-Oncology 2009; 11:923
Volume 11 Issue 6 December 2009
======================================
[19] 13. 12/2009 (Pg. 951)
——————————————————————
Interim Reports on Clinial Trials:
BT-11 BRAIN STEM GLIOMA
(Study (ST) and Special Exception (SE))
Phase II study of antineoplastons A10 and AS2-1 in patients with brainstem glioma
Protocol BC-BT-11
http://www.burzynskiclinic.com/images/stories/Publications/8639.pdf
Neuro-Oncology 2009, 11:951.
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
======================================
[20] 14. 6/2010 (Pg. ii95)
——————————————————————
Interim Reports on Clinical Trials:
BT-13 – CHILDREN WITH LOW GRADE ASTROCYTOMA
A Phase II Study of Antineoplaston A-10 and AS-1 Injections in children with low-grade astrocytomas
http://www.burzynskiclinic.com/images/stories/Publications/8397.pdf
Neuro-Oncology 2010; 12, ii95.
Volume 12 Issue 6 June 2010
Antineoplaston A10 (Atengenal)
Antineoplaston AS2-1 (Astugenal)
======================================
[21] 15. 11/2010 (Pg. iv72)
——————————————————————
Interim Reports on Clinical Trials:
BT-18 – ADULT PATIENTS WITH MIXED GLIOMA
Preliminary Results of a Phase II Study of Antineoplastons A10 and AS2-1 (ANP) in Adult Patients with Recurrent Mixed Gliomas
http://www.burzynskiclinic.com/images/stories/Publications/8637.pdf
Neuro-Oncology 2010; 12:iv72.
Volume 12 Supplement 4 November 2010
======================================