Turkey Lurkey Thanksgiving Title

Traditionally, Thanksgiving is best known as the Holiday that the Detroit Lions get the “stuffing” knocked out of them

However, this year, it’s time to tender the tainted twisted trophy of Thanksgiving Turkey-Lurkey to Detroit’s toasted triumvirate treat of two-faced twerk-salad troll turpitude, and I have the temerity to tinker and tamper until I pay tribute with therapeutic levels of Thoreauness in response to GorskGeek’s misinformation, disinformation, and MisDisInformation (Missed ‘Dis Information)

Wednesday, 12/21/2005, Indianapolis, Indiana-based Eli Lilly and Company was treated to truthification, in connection with their illegal promotion (misbranding) of pharmaceutical drug EVISTA; (FDA approved for prevention and treatment of osteoporosis in post-menopausal women), in the:

a. prevention in risk of breast cancer

b. reduction in risk of breast cancer

Alleged in information, promoted drug as effective for reducing risk of breast cancer EVEN AFTER PROPOSED LABELING FOR THIS USE SPECIFICALLY REJECTED by FDA [1]

GorskGeek, being the breast cancer oncology specialist he claims to be, and so concerned about breast cancer patients that he is that “guy” who speaks out passionately about issues like the 10-year American Cancer Society Cancer Facts & Figures, “Estimated Breast Cancer Deaths for Women”, which reflect that in 2002, 39,600 (15%) women were estimated to die from breast cancer, and this year, 2013, the estimate is 39,620 (14%), which is 20 women MORE than 10-years ago, and who rails tirelessly about the ACS’s “Estimated New Breast Cancer cases in Women”, which 10-years ago was 203,500 (31%) in 2002, and now, in 2013 is 232,340 (29%), which is ONLY
28,840 MORE
than 10-years ago [2]

Now THAT’s progress !

GorskGeek, of course, must accomplish all this under his breath

But I’m sure you’re wondering, dear reader, what was GorskGeek’s outraged blog about this American pharmaceutical manufacturer coughing up $36 MILLION ?

Well, let me tell you … just as soon as I find it

Wait for it

Wait for it

Wait for it

GorskGeek was unable to bring himself to blog about Evista until exactly one year later, on 12/21/2006, and even then, he was “mum’s the word” about the breast cancer claims [3]

Perhaps GorskGeek just “knew” that eventually Evista would finally be approved by the FDA for Eli Lilly’s preventing or reducing risk of breast cancer claims on 9/13/2007, and who were those paper-pushing FDA apparatchiks to prevent Lilly from implementing their “Internal business plan” ? [4-9]

GorskGeek wouldn’t want to damage his slim and non-existent chance of getting some Eli Lilly money for research, by blogging anything that might in any way be possibly construed as him saying anything negatory about the BIG Pharma teat he longs to suck off of

After all, Bob ‘n’ Weave Blaskiewicz (who sees every molehill as a mountain), did say about GorskGeek, 9/28/2013 [10]:
——————————————————————
1:58:04
——————————————————————
“But he is a, the thing is, the thing is, you thing you have to understand is Gorski, Gorski is a genuine expert, in matters re re regarding on oncology studies

“I mean, he has a”

“He, He’s able to convince people, he’s able to convince people, on the strength of his record, to give him money to carry out research

“People who know what they’re talking about”

“To give him money to carry out his research”

“Right ?”
——————————————————————
1:59:00
——————————————————————
Yeah, right

Bobby 🙂

GorskGeek is hoping for a Happy Thanksgiving Golden Parachute; which is where he helps whistleblow about illegal BIG Pharma activity regarding some drug(s), which leaves him as the beneficiary of some funds like Mr. H. Dean Steinke, former Merck employee and his $68,190,000 MILLION from the federal government and states share of settlement amounts:
——————————————————————
$44,690,000 MILLIONMr. H. Dean Steinke, former Merck employee from federal share of settlement amount (1997 – 2001)
——————————————————————
$23.5 MILLIONMr. H. Dean Steinke, former Merck employee from the states share of settlement amount (1997 – 2001)
——————————————————————
Next, GorskGeek goes off on his fave autism prescription antipsychotic drug Risperdal, and the 11/4/2013, Monday, allegations concerning Global health care giant Johnson & Johnson (J&J) and its subsidiaries, $2.2 BILLION + fine regarding J&J Subsidiary Janssen (1999 – 2005) actions [11]
======================================
REFERENCES:
======================================
[1] – 12/21/2005
——————————————————————
EVISTA (FDA approved for prevention and treatment of osteoporosis in post-menopausal women)
——————————————————————
Eli Lilly and Company, Indianapolis, Indiana-based company
——————————————————————
12/21/2005, Wednesday
——————————————————————
$36 MILLION
——————————————————————
In connection with illegal promotion of pharmaceutical drug
——————————————————————
Pleading guilty to criminal count of violating Food, Drug, and Cosmetic Act by misbranding drug
——————————————————————
In addition to criminal plea
agreed to settle civil Food, Drug, and Cosmetic Act liabilities by entering into consent decree of permanent injunction
——————————————————————
Charged in criminal information filed with violation of Food, Drug, and Cosmetic Act, following investigation by Food and Drug Administration’s (FDA) Office of Criminal Investigations
——————————————————————
Plea agreement signed by Lilly and United States

Complaint for permanent injunction

Consent decree of permanent injunction signed by company and United States
——————————————————————
Information alleges 1st year’s sales of drug in U.S. were disappointing compared to original forecast
——————————————————————
According to information
10/1998 – company reduced forecast of drug’s 1st year’s sales in U.S. from $401 million to $120 million
——————————————————————
Internal business plan noted:

“Disappointing year versus original forecast.”
——————————————————————
Information alleges in order to expand sales of drug, Lilly sought to broaden market for drug by promoting it for unapproved uses
——————————————————————
Information alleges strategic marketing plans and promotion touted drug as effective in preventing and reducing risk of diseases for which drug’s labeling lacked adequate directions for use
——————————————————————
According to information: Evista
1. brand team
2. sales representatives
promoted drug for:
a. prevention in risk of breast cancer
b. reduction in risk of breast cancer
c. reduction in risk of cardiovascular disease
——————————————————————
Under provisions of Food, Drug, and Cosmetic Act, drug misbranded when labeling didn’t bear adequate directions for each of intended uses
——————————————————————
Alleged in information, promoted drug as effective for reducing risk of breast cancer even after proposed labeling for this use specifically rejected by FDA
——————————————————————
Information alleges executed illegal conduct using number of tactics, including:

1. One-on-one sales pitches by sales representatives promoting drug to physicians about off-label uses of drug

2. Sales representatives trained to prompt or bait questions by doctors in order to promote drug for unapproved uses

3. Encouraging sales representatives promoting drug to send unsolicited medical letters to promote drug for unapproved use to doctors on their sales routes

4. Organizing “market research summit’ during which drug was discussed with physicians for unapproved uses, including reducing risk of breast cancer

5.
a. Creating
b. distributing
to sales representatives “Evista Best Practices” videotape, in which sales representative states “Evista truly is the best drug for the prevention of all these diseases” referring to:

1). osteoporosis
2). breast cancer
3). cardiovascular disease
——————————————————————
Complaint for permanent injunction alleges executed illegal conduct using number of tactics, including:

1. Training sales representatives to promote drug for prevention and reduction in risk of breast cancer by use of medical reprint in way that highlighted key results of drug and thereby promoted drug to doctors for unapproved use

2. Some sales representatives were instructed to hide disclosure page of reprint which noted:

a. “All of the authors were either employees or paid consultants of Eli Lilly at the time this article was written,”

b. “The prescribing information provides that “The effectiveness of [Evista] in reducing the risk of breast cancer has not yet been established.””

3. Organizing “consultant meetings” for physicians who prescribed drug during which unapproved uses of drug discussed

4. Calculating incremental new prescriptions for doctors who attended Evista advisory board meetings in 1998

5. advisory board meetings included discussion of unapproved uses for drug

6. By measuring and analyzing incremental new prescriptions for doctors who attended advisory board meetings, Lilly was using this intervention as tool to promote and sell drug
——————————————————————
In addition to agreeing to plead guilty to criminal information and plea agreement signed by Lilly, settlement with United States includes following components:

(a) agreed to settle civil Food, Drug, and Cosmetic Act liabilities by entering into consent decree of permanent injunction

(1). As part of consent decree, agreed to comply with terms of permanent injunction, which will require company to implement effective training and supervision of marketing and sales staff for drug, and ensure any future off-label marketing conduct is detected and corrected

(2). agreed to be permanently enjoined from directly or indirectly promoting drug for use in:

a. preventing or reducing risk of breast cancer

b. reducing risk of cardiovascular disease

c. or for any other unapproved use in manner that violates Food, Drug, and Cosmetic Act unless and until FDA approves drug for additional use or uses
——————————————————————
(b) as part of consent decree, agreed to hire and utilize independent organization to conduct reviews to assist Lilly in assessing and evaluating Lilly’s

1. systems
2. processes
3. policies
4. procedures
relating to promotion of drug and company’s compliance with consent decree
——————————————————————
FDA made following announcement to postmenopausal women who have taken drug for prevention or treatment of osteoporosis:
——————————————————————
“No postmenopausal woman who has taken Evista for the prevention or treatment of osteoporosis is affected by this action, as this matter today relates only to unapproved uses of Evista.”
——————————————————————
Defendant agreed to plead guilty to charge in information
——————————————————————
Defendant agreed to resolve complaint for permanent injunction by agreeing to consent decree of permanent injunction
——————————————————————
http://www.justice.gov/opa/pr/2005/December/05_civ_685.html
======================================
[2] – 11/13/2013 – The War on Cancer (I don’t think it means, what you think it says it means) #Winning?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/13/httpcancer-orgacsgroupscontentepidemiologysurveilancedocumentsdocumentacspc-036845-pdf/
======================================
[3] – 12/21/2006 – On the messiness of evidence-based medicine
——————————————————————
http://scienceblogs.com/insolence/2006/12/21/the-messiness-of-evidencebased-medicine/
======================================
[4] – 9/13/2007FDA Approval for Raloxifene Hydrochloride (Brand name(s): Evista®): Approved for breast cancer risk reduction:
——————————————————————
http://www.cancer.gov/cancertopics/druginfo/fda-raloxifene-hydrochloride
======================================
[5] – 9/14/2007FDA Approves New Uses for Evista: Drug Reduces Risk of Invasive Breast Cancer in Postmenopausal Women:
——————————————————————
http://www.fda.gov/newsevents/newsroom/pressannouncements/2007/ucm108981.htm
======================================
[6] – 9/17/2007Evista Approved for Reducing Breast Cancer Risk:
——————————————————————
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048474.htm
======================================
[7] – 2007
——————————————————————
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020815s018lbl.pdf
======================================
[8]
——————————————————————
http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088593.pdf
======================================
[9] – 2007
——————————————————————
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022042lbl.pdf
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[10] – 10/18/2013 – Deconstructing Dr. David H. (Orac) Gorski – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/18/deconstructing-dr-david-h-orac-gorski-september-28-2013-the-skeptics-burzynski-discussion-by-bob-blaskiewicz-21951/
======================================
[11] – 11/4/2013
——————————————————————
http://www.justice.gov/opa/pr/2013/November/13-ag-1170.html
======================================

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)
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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:

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