“The Amazing Meeting” (I don’t think it means, what you think it says it means): 2 Intellectually and Ethically Challenged Individuals, Twaddle at TAM 2013

Gentlemen, I start your Insolence 😇
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(1:30) [1]
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The “motto” of “The Amazing (Not so Much) Meeting” is “Fighting Fakers,” which is apropos, since I doubt that “Orac” the “Check my Facts” Hack of Dr. David H. Gorski, grasps the irony, that when I read some of his blog articles, you could easily switch his name with the name of some individual he is flogging, and the proverbial shoe fits, and:
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(1:40)
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“This is a guy who sometimes fools even, you know, physicians”
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(I couldn’t have said it better, myself) 😊
——————————————————————
(2:47)
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He states:

“There is a long segment about “The Skeptics”

(applause) 😝
——————————————————————
(4:25)
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“His lawyer wrote a book”

“About a half of it is about Burzynski [4]
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6:00
——————————————————————
Gorski mentions that Burzynski noticed that there were higher levels of these chemicals in healthy people, than people with cancer
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Whereas, Burzynski is on record as having said [5]:

” . . . healthy people have abundance of these chemicals in blood
Cancer patients have varied to none

I did NOT know before now, that GorskGeek thinks that “none” is a “level” 😶
——————————————————————
He continues:

AS2.1 – which is a chemical called phenylacetic acid, which is a byproduct of metabolism that turns into phenylacetylglutamine by the liver

A10 – soluble is basically the same thing
It breaks down to PAG
——————————————————————
WOW !

I thought it was: AS2 1 😊

They are “basically the same thing” ? 😳

What does Burzynski say ? [6]

Phenylacetylglutaminate (PG) and Phenylacetate (PN) are metabolites of Phenylbutyrate (PB) and are constituents of antineoplaston AS2-1

PG and PN are naturally occurring in human body as result of metabolism of phenylalanine in liver and kidneys

formulation of antineoplaston AS2-1 is 4:1 mixture of synthetic PN and PG

A10 is 4:1 mixture of PG and iso-PG

That does NOT look like “basically the same thing” to me 😛

20131111-160455.jpg
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(6:50)
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Gorski founders on:

“And these are substances which were actually studied in the ’50’s and ’60’s and not found to be particularly, um, promising, but, he didn’t know that then”
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GorskGeek has #FAILED miserably to prove that on his blogs [7] 😄
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(8:00)
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Gorski comments about Burzynski’s “animal testing,” “species specific” claims:

“There are ways of getting around that”
——————————————————————
But Gorski, again, has #FAILED miserably to prove it [8] 😅
——————————————————————
(12:00)
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Gorski makes lame excuses about the NCI phase II clinical trial [9] 😖
——————————————————————
(12:50)
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Gorski claims Burzynski was indicted for insurance fraud in the 1997 case 😱
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GorskGeek, care to try and prove that one also ? [10] 😃
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(14:25)
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Gorski then states that out of 61 trials on clinicaltrials . gov, “most” are “closed or unknown”
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GorskGeek #FAILED again 😁

At the time it was:

1 – Not Yet Recruiting
(OPEN)(Phase 3)
1 – COMPLETED
2 – WITHDRAWN
(Withdrawn due to slow enrollment)
7 – WITHDRAWN
(This study has been withdrawn prior to enrollment)
(9=WITHDRAWN)
10 – Recruiting
(10=OPEN)
40 – Active, not recruiting –
(40=CLOSED)
61 =TOTAL
——————————————————————
(15:20)
——————————————————————
Gorski attempts to go all “legal eagle”:

“Listen to Burzynski’s lawyer!”

“You listen to Burzynski’s lawyer; and, and I swear I don’t understand, like why Burzynski would let him, let his lawyer say stuff this damning in his own book, but he does”

“So, get a load of some of these quotes, referring to one of the clinical trials, he says:”

“It was a joke”

“. . . there could not be any possibility of meaningful data coming out of the so-called clinical trial, it was all an artifice, that, you know, designed so that they could continue giving the treatment

“The FDA wanted all of his patients to be on an IND, so, that’s what we did”
——————————————————————
Gorski, attorney Rick Jaffe is an American, living in America NOT the formerly communist Poland

He can say whatever he wants

GorskGeek is NOT a lawyer 😓

And there’s an excellent reason why

Nor is he schooled in the proper usage of the English language

FACT:

” . . . the so-called clinical trial . . .”

Any human being with a modicum of intelligence about the English language, understands that the term “clinical trial” is singular, i.e. one

Burzynski’s lawyer is obviously referring to the CAN-1 clinical trial mentioned in Burzynski’s 11/25/1997 Securities and Exchange Commission (SEC) filing [11]

One trial that is retrospective is CAN-1 Clinical Trial
——————————————————————
CAN-1 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH REFRACTORY MALIGNANCIES

133 patients
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Clinical trial of patients treated by Dr. Burzynski through 2/23/1996

FDA has indicated it will not accept data generated by this trial since it was not a wholly prospective one
——————————————————————
Gorski continues his trend of #FAILURES when he mentions the additional types of treatments that Burzynski was offering, but he #FAILED to mention [12] 😂
——————————————————————
” … in 1997, his medical practice was expanded to include traditional cancer treatment options such as chemotherapy, gene targeted therapy, immunotherapy and hormonal therapy in response to FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in the Company’s Antineoplaston clinical trials”
——————————————————————
(18:20)
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Gorski addresses the case of Tori Moreno
——————————————————————
Kim Moreno states:

“We originally were at Miller’s Children at Long Beach Memorial and then went to City of Hope

“We also sent her MRI’s to Dr. Fred Epstein in New York to be looked at”

Gorski suggests that 3 different opinions could have misdiagnosed Tori Moreno

You can read an interview with Tori’s mother [13]
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(19:45)
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Gorski goes on to mention Burzynski patients going to Texas Children’s Hospital with hypernatremia issues
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Gorski, do you mean this ? [14]

The changing pattern of hypernatremia in hospitalized children

Department of Pediatrics, Texas Children’s Hospital, Baylor College of Medicine, Houston, Texas, USA
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(20:00)
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Gorski mangles the case of Hannah Bradley, who had a grade 3 anaplastic astrocytoma brain tumor

GorskGeek makes excuses like “spontaneous remission”, but then provides no citation, reference, or link to a case of such a tumor having spontaneously exhibited remission [15]
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(20:40)
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Gorski states that antineoplastons are chemotherapy
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No, Gorski, antineoplaston are:

“…an unapproved drug, not ordinary “chemotherapy [16] 😣
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(21:53)
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Gorski claims in regard to Burzynski’s personalized gene-targeted therapy:

” . . . gives to the patient without regard for synergistic toxicity

“Boom, there you go”
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Gorski’s #FAIL rate continues, as Burzynski has stated that phase 2 and 3 publications are reviewed as part of this process [17]

Gorski, “BOOM, THERE YOU GO”
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Gorski, you should hire out to the Democratic Party as their mascot, because you must be the biggest pompous ASS I’ve ever seen 😜

Gorski, my advice: don’t quit your day job, HACK 😷
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The #TAM2013 audience then has to suffer through 22:36 of the blatherskite of Robert J. (don’t call me Bobby) “Bob” Blaskiewicz Blatherskitewicz [2]

He blathers about the “dozen,” “17,” “16 dead,” “pancreatic cancer,” “Joseph, who was alive but died well within the life expectancy given his diagnosis,” “Joann, who was alive but died within a year of starting therapy,” “Irene S., who was dead within month,” “Maxine, who was already dead,” the “103 in 2011,” “63 in mid-June,” “17 on original 1999 site,” “about 3 added a year,” the “about 50 stories,” “1/10th of patient names gathered,” “Amelia S. – 7, tumor breaking up,” “Chase,” “Cody – 1994, 20 years ago, 2 visits, 6 weeks treatment breaking up,” “David,” “Janet, 3 – 5 yrs., oncologist, now dead, ovarian cancer,” “Pete took video down,” “8,000 patients,” “probable ischemic necrosis,” “13 yr. old, getting worse getting better, vomited – Marlene, nurse,” “Rory died 2005,” “Supatra, swelling, last wed., brain tumor,” “Side-effect, 2%, sodium load,” “Andrea, U.S. News and World Report, 30% chance recovery, glioblastoma, ANP in luggage, died on plane,” “Cathy wanted to be on ANP, Greg Burzynski, found out only brain tumor,” “Denise D. breast cancer,” and finally:
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(18:45)
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” … and light as many fires under his butt as we can
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Mentions Rick Jaffe’s book Galileo’s Lawyer

IT’S ALL ABOUT THE PATIENTS [4]
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All you need to know about Blaskiewicz is:

“White man speak with forked tongue” [18]
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The 3rd video is a panel discussion, which includes “man-crush” tag-team [3]

Robert Blaskiewicz and David Gorski
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(8:00)
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Bob says:

“Yeah, I’m not that type of doctor
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Bob, the correct answer for you, is:

“I’m NOT a doctor” QUACK
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(13:05)
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Gorski gabs that he’s a:

“Game of Thrones Geek”
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I just knew I was right, GorskGeek [19]
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(14:00)
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The only female panelist mentions “bureaucrats”, “wimps”, and “people without balls”
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2 out of 3 ain’t bad

She describes the Bob and David show to a T
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(15:00)
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The claim is made that a Burzynski physician appeared on the Burzynski Facebook page announcing results
——————————————————————
(16:00)
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Gorski #whines that the Texas Medical Board wasn’t successful in shutting Burzynski down because of “politics”
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LAUGHABLE
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(20:55)
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Gorski gives his usual excuse:

“He’s not an oncologist”
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GorskiGeek, that claim is as dead as apparently, quite a number of your brain cells [15]
——————————————————————
(34:40)
——————————————————————
Audience members are given the opportunity to speak, and this is the garbage served up:
——————————————————————
“Hi, this is Susan

Ah, don’t forget to mention that Wikipedia has been a major battlefield

We’ve had 23,000 views to the clinic’s page this last month, also rebutr . . .”
——————————————————————
“Control the flow of information”
——————————————————————
Gorski pipes up:

“What she said”
——————————————————————
(35:20)
——————————————————————
Blatherskitewicz chimes in:

“When it comes to Wikipedia can I just mention that is, that is, that that is so effective that Wikipedia was singled out in the most recent Burzynski movie
——————————————————————
Gorski chirps:

“Yes”
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Bob yacks:

“as being controlled by evil skeptics
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Gorski ejaculates:

“No, seriously”
——————————————————————
Bob bleats:

“No”

(applause)
——————————————————————
“You have to unleash the evil hoards of skeptics

“Wahahaha” 👿
——————————————————————
Dr. Stanislaw Burzynski on Wikipedia:

“Simply don’t pay attention to it, because it, it’s not true”

“You won’t be able to, do any, clinical research which we do, without convincing evidence, especially when you have the most powerful agency in the government which is against you

“So they would love to find something which is wrong with what we are doing”

“Ah, so the fact that they’ve, um, agreed that what we have has value, and they allow us to do phase 3 clinical trials it means that we are right”

“Because, uh, uh, nobody who didn’t have any, concrete evidence that it works, would be able to go as far”

“So whatever Wikipedia says, well, I don’t care for them

(laughing) [5]
——————————————————————
Enlightening ?

Inspiring ?

Amazing ?

Hypocrites

Apparatchiks [20]
======================================
REFERENCES:
======================================
[1]David Gorski – Why We Fight (Part I): Stanislaw Burzynski Versus Science-Based Medicine – TAM 2013 11/8/2013 (22:44)
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[2]Robert Blaskiewicz – Why We Fight (Part II): It’s All About The Patients – TAM 2013 11/8/2013 (22:36)
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[3] – Medical Cranks And Quacks
TAM 2013 JREF
11/8/2013 (42:42)
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======================================
[4]“Galileo’s Lawyer” Richard A. Jaffe, Esq.
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http://www.richardjaffe.com
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[5] – 11/9/2013 – Pete Cohen chats with Dr. Stanislaw Burzynski:
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https://stanislawrajmundburzynski.wordpress.com/2013/11/09/pete-cohen-chats-with-dr-stanislaw-burzynski/
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[6] – 6/2012 – Journal of Cancer Therapy, 2012, 3, 192-200 doi:10.4236/jct.2012.33028 Published Online June 2012, Pg. 192
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Click to access 9219.pdf

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[7]Burzynski: Oh, RATS!!!:
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https://stanislawrajmundburzynski.wordpress.com/2013/07/26/the-lancet-oncology-peer-review-team-d-12-01519-fail-2/
======================================
[8] – Critiquing: How Stanislaw Burzynski became Burzynski the Brave Maverick Doctor, part 1:
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https://stanislawrajmundburzynski.wordpress.com/2013/07/22/critiquing-how-stanislaw-burzynski-became-burzynski-the-brave-maverick-doctor-part-1/
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[9] – 9/19/2013 – Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet “fact sheet”:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/19/critiquing-national-cancer-institute-nci-at-the-national-institutes-of-health-nih-cancernet/
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[10] – 9/25/2013 – Critiquing: National Council Against Health Fraud, Inc. – NCAHF News: JURY NULLIFICATION THWARTS BURZYNSKI CONVICTION:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/25/critiquing-national-council-against-health-fraud-inc-ncahf-news-jury-nullification-thwarts-burzynski-conviction/
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[11] – 7/9/2013 – Burzynski: The Original 72 Phase II Clinical Trials:
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https://stanislawrajmundburzynski.wordpress.com/2013/07/09/burzynski-the-original-72-phase-ii-clinical-trials/
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[12] – 4/26/2013 – Burzynski: FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in the Company’s Antineoplaston CLINICAL TRIALS:
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https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-fda-requirements-that-cancer-patients-utilize-more-traditional-cancer-treatment-options-in-order-to-be-eligible-to-participate-in-the-companys-antineoplaston-clinical-trials/
======================================
[13] – Tori Moreno
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http://www.cancerinform.org/aburzinterview2.html
======================================
[14] – 9/1999 – Pediatrics. 1999 Sep;104(3 Pt 1):435-9
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/10469766/
======================================
[15] – 11/2/2013 – Critiquing: Dr. Stanislaw Burzynski’s cancer “success” stories:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/02/critiquing-dr-stanislaw-burzynskis-cancer-success-stories/
——————————————————————
10/25/2013 – Hannah Bradley – I Feel Empowered, In Control Of My Body: Four Women On Fighting Cancer With Alternative Therapies http://www.telegraph.co.uk/health/10383724/I-feel-empowered-in-control-of-my-body-four-women-on-fighting-cancer-with-alternative-therapies.html
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/25/hannah-bradley-i-feel-empowered-in-control-of-my-body-four-women-on-fighting-cancer-with-alternative-therapies-httpwww-telegraph-co-ukhealth10383724i-feel-empowered-in-control-of-my-body-fo/
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[16] – NOT ORDINARY CHEMOTHERAPY
——————————————————————
https://bulk.resource.org/courts.gov/c/F3/27/27.F3d.153.93-2071.html
======================================
[17] – 9/4/2013 – University of Michigan, where is alum Dr. David H. “Orac” Gorski’s Grapefruits ?:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/04/university-of-michigan-where-is-alum-dr-david-h-orac-gorskis-grapefruits/
======================================
[18] – 10/13/2013 – Why “The Skeptics™” Perfessor Robert J. (don’t call me “Bobby”) “Bob” Blaskiewicz (@rjblaskiewicz) of University of Wisconsin, Eau Claire, “Fame,” is a Coward and a Liar:
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https://stanislawrajmundburzynski.wordpress.com/2013/10/13/why-the-skeptics-perfessor-robert-j-dont-call-me-bobby-bob-blaskiewicz-rjblaskiewicz-of-university-of-wisconsin-eau-claire-fame-is-a-coward-and-a-liar/
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[19] – 10/27/2013 – “The Skeptics™” Burzynski Bias, Censorship, Lies, and Alibi’s: September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/27/the-skeptics-lie-lied-lies-liars-lying-burzynski-bias-censorship-lies-and-alibis-september-28-2013-the-skeptics-burzynski-discussion-by-bob-blaskiewic/
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[20] – 11/9/2013 – Wikipedia Articles:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/11/burzynski-timeline/
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Advertisement

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

Click to access 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

Click to access 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

Click to access 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

Click to access 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

Click to access 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

Click to access 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

Click to access 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/

Click to access 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

Click to access 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.

Click to access 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

Click to access 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.

Click to access 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.

Click to access 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:

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