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
======================================
[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
======================================

Critiquing: Dr. David H. “Orac” Gorski, M.D., Ph.D, LIAR: Stanislaw Burzynski versus the BBC

Believe in Facts ???

Get out the popcorn !!!
——————————————————————
Dr. David H. “Orac” Gorski is a liar

Let me put that in bold for emphasis

Dr. David H. “Orac” Gorski is a liar

Open wide and say ahhhhhhh …

DR. DAVID H. “ORAC” GORSKI IS A LIAR
——————————————————————
Much better !!!

Some things just look much better when they come in 3’s

And that must be what “Orac” is god thinks, since he seems to live by the the edict of the 3 wise monkeys:
——————————————————————
See No Evil

Hear No Evil

Speak No Evil
——————————————————————
Of course, to Gorski, Evil is any truth which he disagrees with, which he acts like does NOT exist, and obviously can NOT find on the Internet with his Commodore 64, or whatever piece of garbage he’s using, which he must have set to block any websites he wishes to NOT see
——————————————————————
Gorski, the Hypocrite, calls me a “CRANK”, which is especially hilarious, considering how much better my research is than his, without the bias

LIES

Misdirection

Disinformation

Misinformation

MisDisInformation
——————————————————————
David Gorski (@gorskon) tweeted at 3:24am – 14 Jul 13:

@Funkmon @HoracioHornblow Ha ha. It’s the rather pathetic crank Didymus Judas Thomas. That guy couldn’t buy a clue. #Burzynski

——————————————————————
If I wanted to lower myself to Gorski’s level, I could delete comments from my blog
——————————————————————
6/4/2013, Gorski must have evacuated this from deep within his bowels:
� � � � � � � � � � � � � � � �
Stanislaw Burzynski versus the BBC
http://scienceblogs.com/insolence/2013/06/04/stanislaw-burzynski-versus-the-bbc/
� � � � � � � � � � � � � � � �
I was busy at the time reviewing the British Broadcasting Corporation’s Panorama bit on Burzynski:
======================================
6/4/2013

The British are Coming, The British are Coming: Critiquing “Curing cancer or ‘selling hope’ to the vulnerable?”:
https://stanislawrajmundburzynski.wordpress.com/2013/06/04/the-british-are-coming-the-british-are-coming-critiquing-curing-cancer-or-selling-hope-to-the-vulnerable/
======================================
6/7/2013

IT MAY NOT BE SCIENCE: Critiquing “Curing cancer or ‘selling hope’ to the vulnerable?”:
https://stanislawrajmundburzynski.wordpress.com/2013/06/07/it-may-not-be-science-critiquing-curing-cancer-or-selling-hope-to-the-vulnerable/
======================================
But now that I have some time, lets all enjoy Gorski’s LIES

Misdirection

Disinformation

Misinformation

MisDisInformation

While I DISS his MisDisInformation

Since the dates involved are important in exposing Gorski’s LIES, Gorski states:
——————————————————————
“After yesterday’s epic deconstruction of the latest propaganda-fest from … Eric Merola, on his most admired subject, “brave maverick doctor” Stanislaw Burzynski”
——————————————————————
(6/3/2013) in relation to Gorski’s cherry-picked “review” which I critiqued:
======================================
7/18/2013

Critiquing: In which the latest movie about Stanislaw Burzynski “cancer cure” is reviewed…with Insolence:
https://stanislawrajmundburzynski.wordpress.com/2013/07/18/critiquing-in-which-the-latest-movie-about-stanislaw-burzynski-cancer-cure-is-reviewed-with-insolence-2/
======================================
Gorski posits:
——————————————————————
“I needed something science-based to cleanse the rancid taste of intelligence-insulting nonsense from my mind”
——————————————————————
My understanding of Gorski’s definition of #ScienceBasedMedicine is:

1. Visualize a Victim

2. Create biased blogposts utilizing:

a. LIES

b. Misdirection

c. Disinformation

d. Misinformation

e. MisDisInformation

Gorski advises:
——————————————————————
“I was interviewed over the phone by a producer of the show and exchanged e-mails to answer questions”
——————————————————————
I am NOT certain what qualifications BBC Panorama thought that Gorski has in order for him to be interviewed about Burzynski, unless they wanted the perspective of a LIAR

Gorski mentions “False balance”, which readers of his and / or my blog are all too familiar with when it comes to “Orac”

He whines that there is:
——————————————————————
” … zero mention of how Burzynski recently managed to beat an effort by the Texas Medical Board to strip him of his medical license by throwing his employed doctors under the bus …”
——————————————————————
This seems to be:

Misdirection

Disinformation

Misinformation

by Gorski, as anyone can read the case documents:
======================================
Burzynski: Texas Medical Board (TMB) and State Office of Administrative Hearings (SOAH):
https://stanislawrajmundburzynski.wordpress.com/2013/07/18/burzynski-texas-medical-board-tmb-and-state-office-of-administrative-hearings-soah/
======================================
and note that, as Richard A. Jaffe points out, Burzynski was:

1. NOT even in the USA during one of the patients care

2. there was no evidence that Burzynski met either patient

3. Burzynski was NOT the Doctor of Record for either patient

4. If the SOAH had an actual case, they could have gone after the actual Doctors of Record

What Gorski blogs is NOT worth the paper it is NOT written on

EVERYTHING Gorski blogs should be “Fact-Checked” for accuracy

He also ejects:
——————————————————————
” … only the most superficial treatment of how in general it is considered unethical to demand payment from patients to participate in clinical trials”
——————————————————————
though he provides NO basis in FACT for this statement

He also laments:
——————————————————————
“No, and there isn’t any mention of how the Burzynski Clinic waged a campaign of harassment against bloggers who criticized Burzynski back in 2011”
——————————————————————
What Gorski does NOT mention is that:

there isn’t any mention of how the bloggers waged a campaign of harassment against Burzynski

with their:

LIES

Misdirection

Disinformation

Misinformation
======================================
I find Rhys Morgan abnormally prehensile:
https://stanislawrajmundburzynski.wordpress.com/2013/04/20/i-find-rhys-morgan-abnormally-prehensile/
======================================
Gorski cries:
——————————————————————
“Indeed, one of the victims of that harassment, Rhys Morgan, was interviewed by the Panorama crew, but he was informed that his interview was cut from the final version because it didn’t fit the narrative”
——————————————————————
I thought it humorous when The Skeptics™ whined on Twitter that Rhys Morgan wasn’t going to make the cut

What was he going to say ?

How he copied all of his Burzynski blogsplats from other people’s blogs?

Gorski mentions:
——————————————————————
“All you have to do is to read Saul Green’s reports on Quackwatch and in The Cancer Letter from the 1990s”
——————————————————————
Of course, Gorski conveniently forgets to mention Green’s Confict-of-Interest, since Green was associated with a lawsuit against Burzynski

But then again, Gorski seems to have conveniently forgotten his own possible COI, which someone posted a link to on Twitter:
——————————————————————
David Gorski’s Financial PHARMA Ties What He Didn’t Tell You:
http://www.ageofautism.com/2010/06/david-gorskis-financial-pharma-ties-what-he-didnt-tell-you.html
——————————————————————
Gorski fumes:
——————————————————————
“One of them reminded me very much of the conversation with her NHS oncologist that Laura Hymas recorded and allowed Eric Merola to include in his propaganda piece, except that in video it is so much more intense”

“In this scene, the oncologist tries to point out to Ms. Petagine that he doesn’t know what Burzynski is doing or how to take care of her daughter when she returns”
——————————————————————
I guess the National Heath Service oncologist is possibly like Gorski, and he doesn’t know what Burzynski is doing because he has NOT read Burzynski’s publications:
=====================================
7/22/2013

Critiquing: In which Orac does Stanislaw Burzynski propagandist Eric Merola a favor… :
https://stanislawrajmundburzynski.wordpress.com/2013/07/22/critiquing-in-which-orac-does-stanislaw-burzynski-propagandist-eric-merola-a-favor/
======================================
Gorski flabbergasts:
——————————————————————
“The report includes interviews with experts like Professor Richard Grundy of Nottingham Children’s Hospital”

“Grundy points out that Burzynski has not published the complete results of any of his phase II clinical trials”
——————————————————————
What Gorski does NOT point out, is that for being a supposed “expert”, he sure does NOT give the impression that he’s taken the time to read Burzynski’s 2003-2010 phase II (2) clinical trials preliminary reports, in order to qualify as an “expert” on anything related to Burzynski

Gorski continues on as is his custom of being long-winded without much in the way of results:
——————————————————————
” … how Burzynski has abused the clinical trial process to keep treating patients with antineoplastons without actually having to do the science that any other doctor would be required to do to validate a new treatment”
——————————————————————
However, Gorski FAILS to address these issues:
======================================
WHAT IS MISDIRECTION? Critiquing “Antineoplastons: Has the FDA kept its promise to the American people ?”:
https://stanislawrajmundburzynski.wordpress.com/2013/06/08/what-is-misdirection-critiquing-antineoplastons-has-the-fda-kept-its-promise-to-the-american-people/
======================================
Gorski marches onward, jackbooted:
——————————————————————
“Dr. Elloise Garside, a research scientists, echoes a lot of the questions I have, such as how Burzynski never explains which genes are targeted by antineoplastons, what the preclinical evidence supporting their efficacy are, or what the scientific rationale is to expect that they might have antitumor activity”

“(Yes, we’re talking prior plausibility, baby!)”
——————————————————————
So, Gorski is saying that Dr. Elloise Garside has something in common with the “expert”, Professor Richard Grundy

Gorski rants on:
——————————————————————
“The preponderance of evidence supports the contention that they dont’ work, but there is uncertainty, which Burzynski exploits to the max”
——————————————————————
Amazing !!!

The United States Food and Drug Administration has authorized phase III (3) clinical trials, which means:
======================================
“[T]he emphasis in Phase 2 is on EFFECTIVENESS”

“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2″
======================================
Burzynski: The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-the-fdas-drug-review-process-ensuring-drugs-are-safe-and-effective/
======================================
Gorski then blesses us with:
——————————————————————
” … the claims in some of the Q&A’s after screenings of Eric Merola’s most recent movie that Burzynski’s papers have been rejected without being sent out for peer review”

“Studies submitted to journals won’t be published without going out for peer-review”

“Maybe he’s referring to some of the papers we’ve heard about from Mr. Cohen and others that were editorially rejected and not even sent out for peer review because the editor either didn’t think them appropriate or didn’t want to waste the reviewers’ time”
——————————————————————
Gorski, who did a “review” of Burzynski: Cancer Is Serious Business, Part II (2), 6/3/2013, somehow magically “forgets” the very next day, that the documentary indicates that Burzynski submitted a phase II (2) clinical trial for publication, and was refused in 2 hours 8 minutes and 51 seconds, and Gorski is as silent as the dead about the lame reason given for NOT publishing it
======================================
See #12:
======================================
Critiquing: In which the latest movie about Stanislaw Burzynski “cancer cure” is reviewed…with Insolence:
https://stanislawrajmundburzynski.wordpress.com/2013/07/18/critiquing-in-which-the-latest-movie-about-stanislaw-burzynski-cancer-cure-is-reviewed-with-insolence-2/
======================================
How disingenuous, Gorski

Your opinion should mean

Nada

Zip

Zero

“Orac,” the false god continues on his rampage:
——————————————————————
“In science, all that matters is what you publish, and 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 gives NO reason for NOT doing what I have done on my blog, or any relevance of a publication NOT being listed on PubMed:
======================================
The #Burzynski B.S. App:
https://stanislawrajmundburzynski.wordpress.com/2013/06/06/the-burzynski-b-s-app-2/
======================================
Gorski comes to what he must think is his penultimate moment:
——————————————————————
“Without a doubt, the most effective part of the story is the segment in which Dr. Jeanine Graf of the Texas Children’s Hospital is introduced”

“Dr. Graf is the director of the pediatric intensive care unit there and has taken care of lots of Burzynski patients, as her hospital is “just down the road” from the Burzynski Clinic and these unfortunate children are brought to her hospital when they decompensate”

“Particularly damning is how Ms. Petagine said that the Texas Children’s Hospital Staff “were always cleaning up Burzynski’s messes.””

“If there’s one thing Panorama did right in this report, it’s showing how seeing so many already dying children show up in our ICU because of hypernatremia due to antineoplaston therapy will do that”
——————————————————————
Again, Gorski FAILS to discuss:
======================================
Burzynski: HYPERNATREMIA:
https://stanislawrajmundburzynski.wordpress.com/2013/04/24/burzynski-hypernatremia/
======================================
And:
——————————————————————
“Perhaps the most devastating part of this segment was seeing Dr. Graf stating, point blank, that she’s never seen a Burzynski patient survive”
——————————————————————
What is REALLY “devastating” is that Gorski is NOT able to indicate exactly how MANY patients this allegedly applies to, because, whereas Gorski’s fave reporter, Richard Bilton, wants to know how many Burzynski patients were treated in the phase II (2) clinical trials, he acts like Gorski’s “bud”, Dr. Peter A. Lipson, who also has had “issues” with consistency
======================================
Dr. Peter A. Lipson (and / or his Censor(s)) is a Coward: Critiquing “A Film Producer, A Cancer Doctor, And Their Critics”:
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/dr-peter-a-lipson-and-or-his-censors-is-a-coward-critiquing-a-film-producer-a-cancer-doctor-and-their-critics/
======================================
Gorski then rattles off:
——————————————————————
“Burzynski smirks when asked how many patients he’s treated and how many have survived, dodging the question by saying that the FDA won’t let him until he’s published his results”

“Bilton tells him that’s not true; the FDA has told him that Burzynski can tell him as long as he doesn’t promote antineoplastons”

“Burzynski asks Bilton why he doesn’t have a letter from the FDA”
——————————————————————
If Gorski had bothered to read all the comments I posted on his blog re my Burzynski research, he would know that Burzynski has every right to be wary

But Gorski’s arrogance, dismissiveness, and condescension make him his own worst enemy

He then faceplants:
——————————————————————
“Burzynski then promises that antineoplastons will be approved “soon””

“(they almost certainly won’t)”
——————————————————————
I guess Gorski can now see the future, and is all-knowing and omnipotent

But then again, “Orac” is god

“god” goes on to say:
——————————————————————
“Ultimately, the Burzynski Clinic did release some results, stating that 776 patients with brain tumors were treated in trials and that 15.5% have survived five years”

“Of course, this is an utterly meaningless factoid”

“because we don’t know what kinds of tumors, what gradess, how they were treated beforehand, or any other confounding factors”
——————————————————————
But this is because Gorski prefers NOT to pay attention; welcome to “Short Attention Span Theatre”, or seeming to NOT read Burzynski’s publications:
======================================
Colorado Public Television – PBS:
https://stanislawrajmundburzynski.wordpress.com/2013/03/09/colorado-public-television-pbs/
======================================
My Critique of Bob Blaskiewicz (Colorado Public Television – PBS CPT12):
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/my-critique-of-bob-blaskiewicz-colorado-public-television-pbs-cpt12/
======================================
Gorski posted comments on the Colorado Public Television (PBS) (CPT12) Facebook page where this was posted:
======================================

======================================
6/5/2013 Gorski continued his blatherskite:
——————————————————————
Odds and ends left over after the Panorama Burzynski Clinic report: Burzynski versus his own SEC filing
http://scienceblogs.com/insolence/2013/06/05/odds-and-ends-about-burzynski-clinic/
——————————————————————
This is where I start leading to heapin’ helpings of not-so-Respectful Insolence

Gorski posts:
——————————————————————
“(stay classy, Stash, stay classy)”
——————————————————————
I am NOT positive as to why a LIAR would advise Burzynski to “stay classy” when he has absolutely NO moral or ethical standing to do so

The proverbial “pot calling the kettle, black”

Gorski blathers:
——————————————————————
” … in January the Burzynski Clinic removed all references to antineoplaston therapy on its website … “
——————————————————————
As I stated up top, Gorski must have his computer set so that it will NOT access Burzynski’s website, since I posted this:
======================================
3/12/2013

Burzynski updates Scientific Publications page:
https://stanislawrajmundburzynski.wordpress.com/2013/03/12/burzynski-updates-scientific-publications-page/
======================================
This includes the link to Burzynski’s ANTINEOPLASTON publications, which Gorski claims do NOT exist on Burzynski’s website

Perhaps this helps explain Gorski’s lack of knowledge re antineoplastons

Gorski admits:
——————————————————————
“Now I’m not a businessman, and I don’t understand anything but the very basics of business”
——————————————————————
But then goes on to claim:
——————————————————————
“but I do know cancer science”
——————————————————————
Gorski goes on to comment on material which I posted on his blog

Comment #128 Didymus Judas Thomas

At the Tu-Quack Center Correcting Orac’s EPIC & Legendary Research

February 2, 2013
http://scienceblogs.com/insolence/2013/01/21/quoth-joe-mercola-i-love-me-some-burzynski-antineoplastons/
“Yet in the report, we read:”
——————————————————————
On February 23, 2010, the Company entered into an agreement with Cycle Solutions, Inc., dba ResearchPoint (“Research Point”) to initiate and manage a pivotal Phase III clinical trial of combination Antineoplastons A10 and AS2-1 plus radiation therapy (RT) in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma”
——————————————————————
It’s good to see that in JUNE, Gorski is finally catching up to what I posted on his blog in FEBRUARY

Gorski goes on to comment:
——————————————————————
“Of course, given that after three years the clinical trial hasn’t been opened, more than likely no reputable institution wants to partner with the Burzynski Research Institute, and ResearchPoint collected its checks”
——————————————————————
This is the same Gorski who allegedly blogged about the documentary which covered this issue, which he “supposedly” did a“review” on

Gorski, who above claimed that he does NOT understand “business”, suddenly puts on his “lawyer” hat
——————————————————————
“There’s a lot of legalese and FDA bureau-speak, but the meaning should be fairly clear to a layperson”:

“Indeed, even the report seems to concede that antineoplastons will likely never be approved, even going so far to point out that “the Company cannot predict if and/or when it will submit an NDA [New Drug Application] to the FDA, nor can the Company estimate the number or type of additional trials the FDA may require.””

“Burzynski also warns that “there can be no assurance that an NDA for Antineoplastons, as a treatment for cancer, will ever be approved by the FDA.””

“That hardly sounds as though antineoplastons will be approved “soon.””
——————————————————————
I find it remarkable that Gorski, while admitting above that he does NOT understand
“business”, seemingly expects the reader to believe that he understands “legalese”

Gorski bounds on in his new found knowledge as a “legal mastermind”:
——————————————————————
“Another interesting tidbit in the SEC filing is Burzynski’s report of the results of several of his clinical trials”

“They aren’t really “results’ per se, in that the information presented really isn’t provided in a form that really allows other investigators to evaluate it and potentially replicate it”

“Basically it’s a big table listing Burzynski Research Institute clinical trials and response rates reported”

“One thing that I noticed right away is that in most trials, the number of evaluable patients is smaller, sometimes much smaller, than the number of patients accrued”

“This is a huge red flag”

“For instance, in trial BT-20, there were 40 patients accrued by only 22 were evaluable”

“This sort of dropoout rate is a huge red flag”

“We don’t know the reasons for this dropout rate”

“It could certainly skew the results, but even that’s impossible to tell from just a table of response rates and no further information”
� � � � � � � � � � � � � � � �
The ONLY “HUGE RED FLAG” is how inept Gorski is
� � � � � � � � � � � � � � � �
Gorski, you’re no Craig Masilow, but you are a LIAR
� � � � � � � � � � � � � � � �
I’ve done the 1st one for you
======================================
http://www.burzynskiclinic.com/images/stories/Publications/960.pdf

Pg. 96

2 patients unable to be evaluated

patient 2 didn’t have follow-up MRI to determine response

patient 11 died of intratumoral hemorrhage and duration of treatment too short for evaluation of response
======================================
http://www.burzynskiclinic.com/images/stories/Publications/970.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/994.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/1145.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/1146.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/1147.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/1194.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/1220.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/2105.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/5825.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/7287.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/7853.pdf


=====================================
http://www.burzynskiclinic.com/images/stories/Publications/7898.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/8397.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/8637.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/8638.pdf


======================================
http://www.burzynskiclinic.com/images/stories/Publications/8639.pdf


======================================
And THIS is the Gorski who has claimed to have reviewed almost all of Burzynski’s antineoplaston publications
======================================
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/
======================================

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}
� � � � � � � � � � � � � � � � �
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
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:

BT-11

BRAIN STEM GLIOMA

Special exception (SE)

13. 12/2009 (DBSG)

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

12/2009 – Protocol – BRAINSTEM GLIOMAs

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

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

12/2009 – Protocol – BRAINSTEM GLIOMAs

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

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

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

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

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

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

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

36% – antineoplastons: BT-11

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

19% – antineoplastons: special exception (SE)

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

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

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

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

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

The #Burzynski (B.S.) Bump Rap

Yo …

Let me tell you how it’s DONE

We don’t get paid to do IT

We just do it for FUN

We fact-check your SH*T

Until the morning SUN

We know we have you on the RUN

‘Cause you hide behind your keypad SON

We know your “C”-RAP

Because it came out from between your BUNS

And we “Smell What You’re COOKIN’”

And out it COMES

The same ol’ cr*p that rolls right off the tip of your TONGUE

Do you really believe your own HYPERBULL?

Or are you really that DUMB?

I KNOW, who I AM

I AM, Number ONE

I KNOW, who I AM

I don’t fit into your “Master Plan”

(Piss-Off)

I KNOW, who I AM

I AM Number ONE

I KNOW, who I AM

I AM, Number ONE

wiki-wiki-wiki

That’s right WIKIPEDIA

You’re NOT Number ONE

(I got HIS Number)

You threw your MUD

Then hid behind a Black-Hole SUN

You dished out your MUD-BATH

Did you think you had WON?

A Yellow-Journalism AWARD?

(THAT’s just Piss-Poor)

WikipedBiaS!

Did you say WikipediAin’t your SON?

Holy “C”-RAP!!

Did You See THAT!!!

All dressed up wearing your best CummerBUND

Did you think you could get away with thumbin’ your Nose at your own THUMB?

Dum, Dum Dum DUMB

Well here I COME

Like a little TRICKER-TREATER

Get outta here with your SCHTICK!!!

Oh NO, Here comes PETER

Yo, What’s THAT in his HAND?

I don’t think it’s a water METER

Maybe he caught another BOTTOM FEEDER!!!

Yo Yo Ma, I heard it was just another TWITTER TWEETER

Yo, Yo, Yo, YOU want “NEW” INSOLENCE?

I don’t need your “Cult” of “MUD”

“M”isinformation

“U”ndereducated

“D”isinformation

MIS-DIS-INFORMATION

Doctor DISSIMULATION

You’re the Metastasis of Misinformation

The scourge of a NATION

I heard you liked “HUSTLER”

Which explains your problem with Mental Master-Debation

Mel Brooks just called and said “HELLO BALLS”

But I heard your head was on VACATION

“You can’t handle the TRUTH”

If we got you on #MizTV

It’d be like: “really?, Really??, REALLY???”

YO

“You Can’t “C” Me”

You couldn’t handle an Epic Rap Battle of HIS-STORY

You’ve got delusions of “C”-Rappin’ with #Eminem on #MTV

Your #TedNugents #Nugents would be on display for the Whole World Wide Web to SEE

Maybe you should hurry up and run back home to your M-O-M-M-IEEE!!!

I KNOW, who I AM

I AM, Number ONE

I don’t fit into your “Master Plan”

I AM, Number ONE

(It’s better to be Pissed-OFF than Pissed-ON “little man”)

I KNOW, who I AM

I AM, Number ONE

Hey Ho “SkeptiCowards©”

Is THAT all you’ve GOT?

You remind me of Ike TURNER

Was THAT your best SHOT?

Maybe ya betta stay at HOME

Sittin’ on the POT

Until you solve that PROBLEM

That requires too much THOUGHT

Like how to answer a QUESTION

Or “Where are your FACTS?”

Because you’ve been runnin’, hidin’, and DODGIN”

After you had another Faux Tu-Quoque ATTACK

All I hear from some of youse MOUTHS

Is Quack-ack-ack-ack-ACK

I thought Billy Joel warned YOU

Bout having a Heart Attack-ack-ack-ack-ACK

This is the “Home of the BRAVE”

(Maybe you should “Learn to SWIM”)

Before you start to Hack-ack-ack-ack-ACK

George Washington cut down a Cherry TREE

(Was THAT your Cherry-Pickin’ Tree? Whoa is ME!)

They say Lizzie Borden gave her mother 40 Whack-ack-ack-ack-ACKS

• I KNOW, who I AM

I AM, Number ONE

I don’t fit into your “Master Plan” ?

I AM, who I AM

I KNOW, who I AM

I AM, Number ONE

I KNOW who I AM

I AM Number ONE

Oh NO! Here comes Peter AGAIN – FLEA!!

Did he really rob himself to pay PAUL?

I heard him mumble something ’bout CaliCultication

And another Brick in the WALL

Mary told me he denied himself THRICE

As he was trying to Break Down The WALLS

If we don’t hurry up we’ll be LATE

For the World Premiere of the New MONSTER’s BALLS

Lil’ Johnny’s got a DATE

With the New Kids Down the HALL

And we’re going to the “Stones'” CONCERT

We’re gonna throw some BACK

So ya betta’ duck YA’LL

Here’s comes some more Roberta FLACK

Now that wall doesn’t seem so TALL

They’re comin’ to America’s CALL

Now, why is #CMPunk a #Heyman Guy PAUL?

• I KNOW, who I AM

I AM, Number ONE

Your “Master Plan” is like a yellowed Bed Pan

I AM, who I AM

I KNOW, who I AM

I AM, Number ONE

I KNOW who I AM

I AM Number ONE

Oh NO !

Anyone heard ’bout what happens when Birds ATTACK?

Look Out BELOW!

The sky changes from 50 shades of Grey

To #Metallica #FadeToBLACK

Rockapocalypse !!!

@TheRock said #ItDoesntMatter

What BBC Spam-o-rama

the “Riddler” wannabe

or Blatherskitewicz SAID

Your #DavidBowie 15 seconds of #Fame

has you #BurningDownTheHouse with your #TalkingHEADS

#Jabroni

Critics and Cynics

“The Skeptics™”

I thought you had Grapefruits

like @VinceMcMahon

But all you’ve got is #FruityPebbles

like @JohnCena

I feel so ROBbed Van DAMN !!!

what ! What !! WHAT !!!

is your GOAL?

You wouldn’t touch”IT”with a #ZZTop #TenFootPOLE

Your #Garbage smells #Special

#NineInchNails #HeadLikeAHole ?

Your Salem Witch Trial

#HistoryOfTheWorld PartI

was FROZEN

BORING

#PinkFloyd #ComfortablyNUMB

Like a #SuperTramp

You #HideInYourShell

You Blatherskite without a CLUE

Who the … are YOU ?

#WhoAreYou ?

#TheWHO ?

#WeKnowThatTheHypnotizedNeverLie
http://youtu.be/zYMD_W_r3Fg #BloodyWellRight you SEE ?
http://t.co/IY53fEpnBu
You talk about “deconstruction”

#AWESOME

@TripleH #TimeToPlayTheGame ?

#MMA ?

#UFC ?

#WWE ?

Like #KidRock sings

“And this is for the Questions that don’t have any Answers”

U can’t out “C”-Rap ME

Yo #Eminem

May I Have Your Attention PLEASE ?

This ain’t about ME

It’s about the F-D-A
redd.it/1h2slh
and Dr. Stanislaw Rajmund #BURZYNSKI

• I KNOW, who I AM

I AM, Number ONE

I KNOW, who I AM

I AM, who I AM

I KNOW, who I AM

I AM, Number ONE

I KNOW who I AM

I AM Number ONE

“The Skeptics™” Doctor David H. Gorski is one of the “SkeptiCowards©” (I kid you not): Houston, We Have a Problem

The loquacious Dr. David H. Gorski is one of a number of bona fide card-carrying “SkeptiCowards©” (I kid you not)

One has to wonder, when does he (“Orac” @gorskon @oracknows @sciencebasedmed #sciencebasedmedicine) find time to be the so-called ‘self-proclaimed’ “CANCER RESEARCHER” when he’s devoting so much time to his precious blogs?
(http://www.scienceblogs.com/Insolence)

(http://www.sciencebasedmedicine.org)
And, is his devotion to his “Oracolytes” having a deleterious effect on his ability to do the proper “fact-checking” required of his:

Misinformation

Disinformation

MisDisInformation

Misdirection

Dissimulation

Non-Citation(s)

Non-Reference(s)

Non-Link(s)

blatherskitewicz

Dr. Gorski is:

“The Metastasise of MisDisInformation”

“The Doctor of Dissimulation”

He ejaculated this:

Burzynski The Movie: Is Stanislaw Burzynski a pioneering cancer researcher or a quack?

Posted by Orac on November 29, 2011
http://scienceblogs.com/insolence/2011/11/29/burzynski-the-movie-subtle-its-not/
Stanislaw Burzynski: A pioneering cancer researcher or a quack?

Posted by Orac on December 12, 2012
http://scienceblogs.com/insolence/2012/12/12/stanislaw-burzynski-a-pioneering-cancer-researcher-or-a-quack/
“…it’s basically one big conspiracy theory…”

Dr. Gorski raises the issue of “conspiracy theory,, but then is too much of a SkeptiCoward©” (I kid you not), to address that as an issue

As I’ve said before of the “good” Dr. Gorski:

1. Lead

2. Follow, or

3. Get Out of the Way

and he is content to choose “3.”

When men were men:
http://redd.it/1fiok2
When Men Were Men:
http://www.reddit.com/tb/1fiok2
“The Skeptics” Theme Song:
https://stanislawrajmundburzynski.wordpress.com/2013/05/25/the-skeptics-theme-song/
Orac and the Cult of “Misinformation” (Part III):
https://stanislawrajmundburzynski.wordpress.com/2013/03/11/orac-and-the-cult-of-misinformation-part-iii/
IMPORTANT: The live “debate”-A Film Producer, A Cancer Doctor, And Their Critics:
https://stanislawrajmundburzynski.wordpress.com/2013/04/27/important-the-live-debate-a-film-producer-a-cancer-doctor-and-their-critics/
IMPORTANT: The live “debate” that wasn’t-A Film Producer, A Cancer Doctor, And Their Critics:
https://stanislawrajmundburzynski.wordpress.com/2013/04/29/important-the-live-debate-that-wasnt-a-film-producer-a-cancer-doctor-and-their-critics/
Thawing out “The Skeptics” @FrozenWarning (FrozenBoring):
https://stanislawrajmundburzynski.wordpress.com/2013/06/01/thawing-out-the-skeptics-frozenwarning-frozenboring/