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

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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/
======================================

Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 8)

onforb.es/11pwse9

http://t.co/vh3cgAR6hW

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

Musings on the intersection of Articles, Bias, and Censorship

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

4/19/2013 @ 9:43PM

A Film Producer, A Cancer Doctor, And Their Critics

FW 1 week ago

“Erm, what conflict of interest?”

FW (also known as @frozenwarning), your “conflict of interest” with “facts”

Do you know how utterly, completely, fruit looping bonkers that is?

Seriously, get a grip.

FW 1 week ago

“Sadly Burzynski isn’t following FDA standards, as their warning letters and current inspection shut down proves.”

FW, being from the United Kingdom, are you even knowledgeable about the FDA warning letter process?

“He’s been doing his “research” for 40 years.”

“How long do you think he should be allowed to continue without showing his data?”

FW, what do you call THIS ?

Burzynski Clinical Trials (The SEC filings)
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2
“As I said earlier, the Phase 3 trial has been registered since 2010 and Burzynski shows no inclination to start it, having NOT A SINGLE PATIENT RECRUITED.”

FW, as I said earlier, did you pay attention to this?

Burzynski: Not every cancer clinical trial taking place in the United States is listed on our NCI clinical trials database
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-not-every-cancer-clinical-trial-taking-place-in-the-united-states-is-listed-on-our-nci-clinical-trials-database
Burzynski’s Securities and Exchange Commission (SEC) Form 10-Q for the quarterly period ended 5/31/2010 states:

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

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

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

ResearchPoint is currently conducting feasibility assessment

ResearchPoint has secured interest and commitment from number of sites selected

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

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

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

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

“I’ll tell you what these patients lose, they lose time, and quality of life, and hundreds of thousands of dollars on an unproven therapy that they are being misled about, and no-one in that situation deserves that.”

FW, isn’t EVERY drug in the clinical trial process “unproven therapy,” until such time as the FDA approves it?

Are you saying that because EVERY drug in the clinical trial process is “unproven therapy,” there should be NO clinical trials AT ALL?

FW 1 week ago

“Hah, if the FDA took any notice of the criticism, then I’m glad to hear it, though if Burzynski had not conducted his trials in an unethical and unscientific way, which was obvious merely from what his patients reported, they would have had no reason to shut his operation down.”

FW, what information do you have from the FDA that supports your comments?

“Why continue?”

“Well, there’s the so called gene targeted therapy that he still peddles for vast amounts of money, which isn’t gene targeted at all, merely a way of selling random scattergun, often off label chemotherapy.”

FW, where are your reliable independent sources (citation(s), reference(s), and / or link(s)?

“There are no retainers, that’s another of your usual batshit theories, used instead of answering the questions.”

FW, I’m still waiting for you to answer my questions

“Classy of you to use my family bereavements in such a way though.”

“I can assure you, they got the best care available and luckily no quack ever tried to con them. If they had, they would have got short shrift.”

FW, so, unfortunately, even though your family “got the best care available,” they still passed?

Which also happens to Burzynski

rjblaskiewicz 1 week ago

“Damn it, Eric. Wouldn’t your time be better spent recutting your movie so it didn’t suck?”

rjblatherskiewicz, I don’t see you on here with your lame comments:

Have you heard of Anthony Jeselnik’s “Defend Your Tweet?”

I’d like to find out how you’d “Defend Your Comments”

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
Critiquing Bob Blaskiewicz (#Burzynski Cancer is Serious Business, Part II)
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/critiquing-bob-blaskiewicz-burzynski-cancer-is-serious-business-part-ii
Boris Ogon 1 week ago

(citing Astroturfwatch’s comments):

“They refuse to fact check anything. Namely Phase 2 results showing a 25% cure rate for brainstem glioma, never accomplished in medical history—ever.”

“Published plan as day in a ‘internationally peer-reviewed’ article.”

(Boris Ogon)

“You mean PMIDs 12718563 and 16484713? (These, at least, are the ones that Merola cites, which I assume is the sum total of your “fact checking.”)”

Mr. Ogon, I don’t see any comments from “Merola” on the Forbes comments, but maybe you are referring to Astroturfwatch’s comments:

“Namely Phase 2 results showing a 25% cure rate for brainstem glioma, never accomplished in medical history—ever”

“Notice the chart on page 172 (page 8 of PDF).”

“Find just one, any single cure for this tumor type and you can’t, outside of Antineoplastons FDA sanctioned clinical trials:”
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf
(Boris Ogon)

“Let’s take them in turn, noting first that

“(1) neither represents the results of a completed Phase 2 trial and”

“(2) it’s essentially the same group in both.””

“We know the following about the ultimate group of 13:”

““Medulloblastoma was diagnosed in 8 patients, pineoblastoma in 3 patients, and other PNET in 2 patients.”

“Prior therapies included surgery in 12 patients (1 had biopsy only, suboccipital craniotomy), chemotherapy in 6 patients, and radiation therapy in 6 patients.”

“Six patients had not received chemotherapy or radiation.”

“The first reference is to Drugs in R&D 4:91 (2003).”

“This is a pharmacy journal, which immediately calls into question the adequacy of the available peer review.”

“It also appears to have briefly gone out of business, with no articles published in 2010.”

“Its JCR IF for 2009 was 1.354, which represented an increase of “more than 35%” of 2008; it did not even have an IF in 2011, but in this year, it was ranked 114 out of 221 in its SCImago category, *after* it had switched to “Gold OA,” which may well lead one to wonder whether it was even a third-tier journal earlier on.”

“The side effects included anemia, hypernatremia, agranulocytosis, and granulocytopenia.”

“End result?”

“The results of this study compared favourably with the responses of patients treated with radiation therapy and chemotherapy.”

“Color me unimpressed.”

“This gets better with the next one, though.”

“The second reference is to Integrative Cancer Therapies 4:168 (2005).”

“One may suspect from the title that we may have a problem here.”

“A look at the current editorial board leaves one distinctly unimpressed.”

“In particular, it includes *Ralph Moss.*”

“If this name doesn’t immediately set of a warning klaxon in your head, you’re not familiar with cancer crankery.”

“With a 2011 IF of 2.136, it currently ranks 118 of 196 in the JCR oncology category.”

“It shared this number with papers about acupuncture and green tea, but let’s cut to the chase:”

“The percentage of patients’ response is lower than for standard treatment of favorable PNET.”

“That’s right, “antineoplastons” did *worse* than standard treatment.”

“He tries to salvage something from this mess by suggesting that “antineoplastons” might someday prove useful for some categories of PNETs.”

“*Neither* paper claims superiority over conventional treatment.”

Mr. Ogon, where did you get your data from?

The “chart on page 172 (page 8 of PDF):”
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf
refers to:

2006 Adis – Pediatr Drugs 2006; 8 (3)

pg 172

Treatments for Astrocytic Tumors

Table II. Treatment of 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
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
[% (no. )]
27 (8) – CR – CR = complete response
[% (no. )]
20% (6) – PR – PR = partial response
[% (no. )]
23% (7) – SD – SD = stabile disease
30% (9) – PD = progressive disease

pg 177

88. Burzynski SR, Weaver RA, Janicki T. Long-term survival in phase II studies of antineoplastons A10 and AS2-1 (ANP) in patients with diffuse intrinsic brain stem glioma [abstract]. Neuro-oncol 2004; 6: 386

This is the 2004 publication, NOT 2003

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/m/pubmed/15563234
Drugs R D. 2004;5(6):315-26

pg 172

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}

(Above, I also provide the best next case to compare to)

pg 177

89. Burzynski SR, Weaver RA, Janicki TJ, et al. Targeted therapy with ANP in children less than 4 years old with inoperable brain stem gliomas [abstract]. Neuro-oncol 2005; 7: 300

Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with antineoplastons A10 and AS2-1.
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
Integr Cancer Ther. 2005 Jun;4(2):168-77

pg 173

1.4.3 Targeted Therapy

“…multi-targeted therapy with ANP has shown promising results [12;88-91]”

pg 176

90. Burzynski SR, Lewy RI, Weaver RA, et al. Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma: a preliminary report. Drugs R D 2003; 4: 91-101

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/m/pubmed/12718563
Drugs R D. 2003;4(2):91-101

91. Burzynski SR, Weaver RA, Janicki T. et al. Targeted therapy with antineoplastons A10 and AS2-1 (ANP) of high-grade, recurrent and progressive brain stem glioma. Integr Cancer Ther 2006 Mar; 5 (1): 40-7

Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma.
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713

Integr Cancer Ther. 2006 Mar;5(1):40-7

30 evaluable patients with recurrent and progressive DBSG

“>40% of patients survived for more than 2 years
30% more than 5 years.”

27% – CR – Complete Response
20% – PR – Partial Response
23% – SD – Stable Disease
30% – PD – Progressive Disease
[12,88]

pg 175

12. Burzynski SR Targeted therapy for brain tumors In: Columbus, F editor. Brain cancer research progress. New York: Nova Science Publishers Inc 2005

pg 173

10 evaluable children
aged <4 years diagnosed with DBSG treated with ANP
youngest 3-month-old infant
[89]

60% – 2-year survival rate
20% – 5-year survival rate
maximum survival more than 7 years

30% – CR – Complete Response
40% – SD – Stable Disease
30% – PD – Progressive Disease
[89]

“The results are compiled in table II.”

pg 174

2.3. Targeted Therapy

Multi-targeted ANP therapy is free from chronic toxicity in children and adults based on the results of numerous clinical studies involving

1652 adults
335 children
[147]

pg 178

147. Burzynski SR. Annual report to the FDA, IND 43,742, 2006

pg 174

Long-term follow-up of children treated with ANP for astrocytomas revealed:
normal development
no cognitive or endocrine deficiencies
normal fertility

>5 years – substantial number of patients tumor free
>17 years – follow-up period for some patients

pg 169

1.1.4. Targeted Therapy

Clinical trials with agents affecting single targets are in progress and the preliminary results of multi-targeted therapy with
antineoplastons (ANP) A10
and
AS2-1 have been reported
[39]

small group of patients with progressive LGA, ANP
60% – CR rate – Complete Response
10% – PR rate – Partial Response
median survival 7 years 9 months
maximum survival of more than 15 years
[39]

LGA = Low-Grade Astrocytomas
Table I. Selected chemotherapy regimens for the treatment of 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 {(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}
CR [% (no.)]
60% (6) – CR = complete response {24 (11) next closest}
PR [% (no.)]
10% (1) – PR = partial response {60% (9) best other study}
[% (no.)]
30% (3) – SD = stable disease + MR = minor response {70% (14) best other study}
[% (no.)]
0% (0) – PD = 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}

(Above, I also provide the best next case to compare to)

pg 176

39. Burzynski SR Clinical application of body epigenetic system: multi-targeted therapy for primary brain tumors. World and Ehrlich Conference on Dosing of Magic Bullets; 2004 Sep 9-11 Nurnberg

“One further has to take into account the fact that Scamley has been known to employ idiosyncratic definitions, such as classifying tumor *growth* as “stable disease” for “less than 50% reduction in size but no more than 50% increase in size of the tumor mass, lasting for at least twelve weeks.””

Mr. Ogon, did you read THIS ?

Burzynski: STABLE DISEASE
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-stable-disease
5/2007 – Guidance for Industry – Food and Drug Administration
Guidance for Industry

Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics

U.S. Department of Health and Human Services Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

May 2007 Clinical/Medical

“STABLE DISEASE should not be a component of ORR

STABLE DISEASE can reflect the natural history of disease”

(Pg. 10 of 22 = actual pg. 7 of PDF)
“…STABLE DISEASE can be more accurately assessed by TTP or PFS analysis (see below)”
(Pg. 11 of 22 = actual pg. 8 of PDF)

Time to Progression and Progression-Free Survival

TTP – Time to Progression

PFS – Progression-Free Survival

Time to Progression and Progression-Free Survival

TTP and PFS have served as primary endpoints for drug approval

TTP and PFS have served as primary endpoints for drug approval
(Pg. 11 of 22 = actual pg. 8 of PDF)

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf
And in addition, the below 2005 non-Burzynski study also uses “STABLE DISEASE:”

Role of temozolomide after radiotherapy for newly diagnosed diffuse brainstem glioma in children
Results of a multiinstitutional study (SJHG-98)

http://www.ncbi.nlm.nih.gov/m/pubmed/15565574
St. Jude Children’s Research Hospital (Memphis, TN)
29 (88)
Texas Children’s Medical Center (Houston, TX)
2 (6)
Children’s Medical Center (Dallas, TX)
2 (6)
Cancer. 2005 Jan 1;103(1):133-9
Cancer 103, 133-139
Cancer Volume 103, Issue 1, pages 133–139, 1 January 2005
DOI: 10.1002/cncr.20741
Article first published online: 24 NOV 2004
American Cancer Society

http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/full
“Protip:”

“Before you start crying about how “‘fact-checking’ is no longer even on the table,” you might want to try figuring out what it actually is first.”

Mr. Ogon, what was that about

“fact-checking” ?

Lynne 1 week ago

“Angel of life, let me point out that there are many accounts of brain cancer survivors who were treated with conventional medicine.”

“Burzynski is not the only one.”

“A simple google search reveals that there are several cancer survivor groups and other accounts of healing via traditional scientific medicine.”

“Just one example:”

“virtualtrials.org”

“(go to the bottom of the page and click on survivor stories)”

“features 37 brain cancer patients who have survived from 5-30 years by choosing cutting edge research and clinical trials.”

“Their stories are identical to those of Burzynski patients.”

“Some people are just fortunate in their response to chemo, and make no mistake, Burzynski uses chemo.”

“There are a lot more examples out there.”

“Burzynski has not shown conclusively that he has a higher survival rate than conventional medicine, which would be so easy for him to do.”

Lynne, did you look HERE ?

Burzynski Clinical Trials (The SEC filings):
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2
“He could post it tomorrow; it doesn’t have to be in a peer reviewed journal.”

Lynne, at least you’re right about that:

Burzynski: What happens when a clinical trial is over?
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-what-happens-when-a-clinical-trial-is-over
“Instead, we are asked to just believe him because he’s such a nice guy who cares so much.”

Lynne, that’s one way to do it:

Burzynski: Declaration of Helsinki
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-declaration-of-helsinki
“To complete the equation, you have to know the denominator:”

Lynne, that’s another option:

Burzynski: FAQ: Clinical Trial Results
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-faq-clinical-trial-results/
“how many didn’t make it.”

Lynne, you could ask that too:

Antineoplastons: Has the FDA kept its promise to the American people ?
https://stanislawrajmundburzynski.wordpress.com/2013/03/22/antineoplastons-has-the-fda-kept-its-promise-to-the-american-people
“Conventional medicine is transparent and reports failures.”

Lynne, if you say so, though you provide no citation(s), reference(s), and / or link(s):

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
“Burzynski doesn’t.”

Lynne, if you say so:

Burzynski – The Antineoplaston Randomized Japan Phase II Clinical Trial Study:
https://stanislawrajmundburzynski.wordpress.com/2013/03/28/burzynski-the-antineoplaston-randomized-japan-phase-ii-clinical-trial-study
“Just another reason the body of scientists don’t find him credible.”

Lynne, like THESE ?

Burzynski referenced by other Cancer researchers:
https://stanislawrajmundburzynski.wordpress.com/2013/04/24/burzynski-referenced-by-other-cancer-researchers
Boris Ogon

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

3,799
views

Not so much

Waiting for the 10,000

4/19/2013 @ 9:43PM

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

Burzynski: The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective

“The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective” advises:
“[T]he emphasis in Phase 2 is on EFFECTIVENESS”
“This phase aims to obtain PRELIMINARY DATA on whether the drug works in people who have a certain disease or condition”
“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2″
“These studies gather more information about safety and EFFECTIVENESS, studying different populations and different dosages and using the drug in combination with other drugs”
http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm