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

Believe in Facts ???

Get out the popcorn !!!
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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
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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:
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See No Evil

Hear No Evil

Speak No Evil
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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
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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
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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

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If I wanted to lower myself to Gorski’s level, I could delete comments from my blog
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6/4/2013, Gorski must have evacuated this from deep within his bowels:
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Stanislaw Burzynski versus the BBC
http://scienceblogs.com/insolence/2013/06/04/stanislaw-burzynski-versus-the-bbc/
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I was busy at the time reviewing the British Broadcasting Corporation’s Panorama bit on Burzynski:
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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/
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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/
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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:
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“After yesterday’s epic deconstruction of the latest propaganda-fest from … Eric Merola, on his most admired subject, “brave maverick doctor” Stanislaw Burzynski”
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(6/3/2013) in relation to Gorski’s cherry-picked “review” which I critiqued:
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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/
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Gorski posits:
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“I needed something science-based to cleanse the rancid taste of intelligence-insulting nonsense from my mind”
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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:
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“I was interviewed over the phone by a producer of the show and exchanged e-mails to answer questions”
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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:
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” … 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 …”
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This seems to be:

Misdirection

Disinformation

Misinformation

by Gorski, as anyone can read the case documents:
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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/
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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:
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” … only the most superficial treatment of how in general it is considered unethical to demand payment from patients to participate in clinical trials”
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though he provides NO basis in FACT for this statement

He also laments:
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“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”
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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
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I find Rhys Morgan abnormally prehensile:
https://stanislawrajmundburzynski.wordpress.com/2013/04/20/i-find-rhys-morgan-abnormally-prehensile/
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Gorski cries:
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“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”
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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:
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“All you have to do is to read Saul Green’s reports on Quackwatch and in The Cancer Letter from the 1990s”
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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:
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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
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Gorski fumes:
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“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”
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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:
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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/
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Gorski flabbergasts:
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“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”
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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:
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” … 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”
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However, Gorski FAILS to address these issues:
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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/
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Gorski marches onward, jackbooted:
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“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!)”
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So, Gorski is saying that Dr. Elloise Garside has something in common with the “expert”, Professor Richard Grundy

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

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

“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2″
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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/
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Gorski then blesses us with:
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” … 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”
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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
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See #12:
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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/
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How disingenuous, Gorski

Your opinion should mean

Nada

Zip

Zero

“Orac,” the false god continues on his rampage:
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“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”
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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:
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The #Burzynski B.S. App:
https://stanislawrajmundburzynski.wordpress.com/2013/06/06/the-burzynski-b-s-app-2/
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Gorski comes to what he must think is his penultimate moment:
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“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”
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Again, Gorski FAILS to discuss:
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Burzynski: HYPERNATREMIA:
https://stanislawrajmundburzynski.wordpress.com/2013/04/24/burzynski-hypernatremia/
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And:
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“Perhaps the most devastating part of this segment was seeing Dr. Graf stating, point blank, that she’s never seen a Burzynski patient survive”
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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
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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/
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Gorski then rattles off:
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“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”
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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:
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“Burzynski then promises that antineoplastons will be approved “soon””

“(they almost certainly won’t)”
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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:
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“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”
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But this is because Gorski prefers NOT to pay attention; welcome to “Short Attention Span Theatre”, or seeming to NOT read Burzynski’s publications:
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Colorado Public Television – PBS:
https://stanislawrajmundburzynski.wordpress.com/2013/03/09/colorado-public-television-pbs/
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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/
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Gorski posted comments on the Colorado Public Television (PBS) (CPT12) Facebook page where this was posted:
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6/5/2013 Gorski continued his blatherskite:
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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/
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This is where I start leading to heapin’ helpings of not-so-Respectful Insolence

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

Burzynski updates Scientific Publications page:
https://stanislawrajmundburzynski.wordpress.com/2013/03/12/burzynski-updates-scientific-publications-page/
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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:
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“Now I’m not a businessman, and I don’t understand anything but the very basics of business”
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But then goes on to claim:
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“but I do know cancer science”
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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:”
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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”
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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:
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“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”
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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
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“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.””
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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”:
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“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”
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The ONLY “HUGE RED FLAG” is how inept Gorski is
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Gorski, you’re no Craig Masilow, but you are a LIAR
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I’ve done the 1st one for you
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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
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http://www.burzynskiclinic.com/images/stories/Publications/970.pdf


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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And THIS is the Gorski who has claimed to have reviewed almost all of Burzynski’s antineoplaston publications
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11/2/2012

“Personally, having pored over Burzynski’s publications … “
http://scienceblogs.com/insolence/2012/11/02/stanislaw-burzynski-fails-to-save-another-patient/
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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/
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Is Dr. David H. “Orac” Gorski Down and Out in Detroit and an Ethically Bankrupt Researcher ?

After Gorski’s “research” of Burzynski’s phase I (1) clinical trials:

Critiquing: How Stanislaw Burzynski became Burzynski the Brave Maverick Doctor, part 1:
https://stanislawrajmundburzynski.wordpress.com/2013/07/22/critiquing-how-stanislaw-burzynski-became-burzynski-the-brave-maverick-doctor-part-1/
he asserts:

“For one thing, in 1976 Burzynski had no animal data to speak of”

“In fact, the question of animal studies is an interesting one”

“Both Elias and Jaffe recount a story in which ANPs didn’t work in animal tumors, and Burzynski has been quoted in multiple places as claiming that ANPs are species-specific and that ANPs derived from human blood and urine don’t work in animal tumor models”

“This is in contrast to what Null reports in his near-contemporaneous account, in which he stated that in tissue culture and animal models Burzynski’s ANPs worked “specifically against certain types of cancer,” all with “no toxic side effects”

“It makes one wonder whether the “species specificity” was an excuse developed later to explain the lack of animal data”
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National Cancer Institute (NCI) at the National Institutes of Health (NIH)

Laboratory/Animal/Preclinical Studies:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page4
“Burzynski states that antineoplaston A is species-specific because it had no therapeutic effect when the human preparation was tested on animal tumor systems”

“Although this finding limits the usefulness of animal model testing, the developer has suggested that a “marked” therapeutic effect was produced in a xenograft bearing human tumor tissue.[1]”

“This claim is made only for antineoplaston A”

“Other formulations of antineoplastons have not been tested in animal models”

Gorski should REALLY read his own blog:
http://scienceblogs.com/insolence/2013/01/21/quoth-joe-mercola-i-love-me-some-burzynski-antineoplastons/
Comment #158 – Didymus Judas Thomas

At the Tu-Quack Center Educate Orac Oracle Phase I

February 4, 2013

.11/15/1982.- 2 Toronto physicians, Martin E. Blackstein, Head of the Division of Oncology at Mount Sinai Hospital & Daniel E. Bergsagel, Chief of Medicine at Princess Margaret Hospital, visited the Burzynski clinic & research institute
.
Both were powerful & respected physicians in the Canadian cancer establishment
.
They returned with a blistering, critical report
.
The essence of their critique was
.
(1) there was little evidence that antineoplastons had significant antitumor activity against human or animal cancers;
.
(2) SRB’s argument that antineoplastons were species-specific created a line of argument for avoiding standard animal & tissue culture screens & required testing in humans
.
SRB cooperated but was dubious
.
There were several test-tube & preventative models in which the drug had showed effectiveness, but the standard NCI pre-screen, P388 mouse leukemia, was not 1 of them. …
.
As he had predicted, these compounds were not effective against mouse leukemia
.
SRB reasonably suggested that NCI try the Antineoplastons in cell-culture assays that were similar to “human solid tumors, especially adenocarcinoma of the breast” …
.
SRB was hardly alone in voicing doubts about the P388 mouse model
.
1983 – Ironically, it was Dr. John Vendetti himself, chief of the NCI’s Drug Evaluation Branch, who coauthored an article in which he argued the limitations of this very mouse system
.
Scientists at NCI had found, for instance, that of 79 drugs which had previously been judged negative in the P388, 14 showed “significant activity” when retested in cell culture assays [1] [2]

Comment #163 – Didymus Judas Thomas

February 4, 2013

Orac’s blog hates links reformatting (www removed)
.
[1] http://www.commonweal.org/pubs/choices/21.html
[2] 9 Moss, The Cancer Ind., 14, 299-300
(Ralph Moss, The Cancer Industry)

27. Burzynski SR, Hendry LB, Mohabbat MO, et al. Purification of structure determination, synthesis and animal toxicity studies of antineoplaston A10. In: Proceedings of the 13th International Congress of Chemotherapy. Vienna, Austria; 1983:17, PS. 12.4 11-4.

34. Burzynski SR, Mohabbat MO, Burzynski B. Animal toxicology studies on oral formulation of antineoplaston A10. Drug Exptl Clin Res. 1984;10:113-118.

40. Ashraf AQ, Liau MC, Kampalath BN, et al. Pharmacokinetic study of radioactive antineoplaston A10 following oral administration in rats. Drugs Exptl Clin Res. 1987;13(suppl 1):45-50.
http://www.ncbi.nlm.nih.gov/pubmed/3569015/

http://www.ncbi.nlm.nih.gov/m/pubmed/3569015/
43. Ashraf AQ, Kampalath BN, Burzynski SR. Pharmacokinetic analysis of antineoplaston A10 injections following intravenous administration in rats. Adv Exptl Clin Chemother. 1988;6:33-39.

QUESTIONS the Critics and Cynics, “The Skeptics™” do NOT want to ANSWER

1. One “Orac” (Dr. David H. Gorski @oracknows @sciencebasedmed @gorskon #sciencebasedmedicine
http://www.scienceblogs.com/Insolence
http://www.sciencebasedmedicine.org)
claimed:


“Burzynski naturally has lots of excuses for why the trial failed and tried to blame the investigators, but his complaints are not convincing.”

When I requested that he respond to Burzynski’s comments re the study, he would NOT touch it with the proverbial ZZ Top

“Ten-Foot Pole”

What Critic, Cynic, or one of “The Skeptics™” is going to show more Bravery and Courage than “Orac”?
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2. If antineoplastons do NOT work, why, after Dvorit D. SAMID learned of them from Burzynski, did all the research, clinical studies, and phase I, phase II, and phase III clinical trials really start to get underway on
PHENYLACETYLGLUTAMINATE (PAG or PG)
PHENYLACETATE (PN)

and
PHENYLBUTYRATE (PB)?
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3. This individual claims to be a “cancer researcher”

If this individual’s “research” is so poor as a “cancer researcher,” what does that say about “research” re the “War on Cancer”?

My review of C0nc0rdance:
https://stanislawrajmundburzynski.wordpress.com/2013/03/23/my-review-of-c0nc0rdance/
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4. This individual claims to be a “Doctor,” “oncologist,” “breast cancer specialist,” and “cancer researcher”

If this individual’s “research” is so poor as a “cancer researcher,” what does that say about “research” re the “War on Cancer”?

Paging Doctor David H. Gorski, Paging Doctor David H. Gorski: There’s Mud in your Ears … Doktor Gorski?:
https://stanislawrajmundburzynski.wordpress.com/2013/05/28/paging-doctor-david-h-gorski-paging-doctor-david-h-gorski-theres-mud-in-your-ears-doktor-gorski/
He did NOT even refer to the below publication by Burzynski regarding “Treatment of Recurrent Triple-Negative Breast Cancer:”

8/2011 – Successful Treatment of Recurrent Triple-Negative Breast Cancer with Combination of Targeted Therapies
http://www.scirp.org/journal/PaperDownload.aspx?DOI=10.4236/jct.2011.23050
Journal of Cancer Therapy, 2011, 2, 372-376
doi:10.4236/jct.2011.23050 Published Online August 2011
(http://www.SciRP.org/journal/jct)
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5. Critics, Cynics, “The Skeptics™” state that Burzynski is NOT an oncologist, but can offer no explanation as to why this is supposedly “relevant,” they cannot explain if oncologists are somehow “better” than biochemists, nor do they want to answer the question:

“Does Burzynski work with any oncologists, and are any of them listed on his phase II clinical trial publications”?

http://www.burzynskiclinic.com/scientific-publications.html
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
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6. The British Broadcasting Corporation (BBC) Panorama program indicated that 776 Burzynski patients with brain tumours were treated in trials before 2008
http://t.co/nFpwlQg275
15.5% (120) survived more than 5 years

Critics, Cynics, “The Skeptics™”, what’s your survival rate?
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7. March 29, 1996

Then United States Food and Drug Administration Commissioner, David A. 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 information … up 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 accessavailabilityfor American patients for any drugthere’s reason to believemay work
——————————————————————
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”?

https://stanislawrajmundburzynski.wordpress.com/2013/06/08/what-is-misdirection-critiquing-antineoplastons-has-the-fda-kept-its-promise-to-the-american-people/
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8. The British Broadcasting Corporation (BBC) Panorama program indicated that 776 Burzynski patients with brain tumours were treated in trials before 2008
http://t.co/nFpwlQg275
Is that what the FDA means by:

rely on … fewer patients?
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9. 4/27/2013 (37:20) Fabio stated that
Burzynski had provided the FDA with 2.5 million pages of clinical trial documents

Is that what the FDA means by:

“unnecessary paperwork”?

and

“less information … up front”?
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10. Is this what the FDA means by:
https://stanislawrajmundburzynski.wordpress.com/2013/06/08/what-is-misdirection-critiquing-antineoplastons-has-the-fda-kept-its-promise-to-the-american-people/
if there is evidence … of partial response in clinical trials?
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11. Why was the United States Food and Drug Administration requiring that radiation be used in the Phase 3 Clinical Trial when Burzynski has shown better results with antineoplastons when radiation is NOT used?
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12. Who wants to defend the excuse that The Lancet gave for NOT Publishing the documentation which Burzynski sent to them, which is referred to in Burzynski: Cancer is Serious Business, Part II?
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13. Review Articles on Clinical Trials: 2. 2006 – Treatments for Astrocytic Tumors in Children: Current and Emerging Strategies. Pediatric Drugs 2006;8:167-178.
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf
2006 Adis – Pediatr Drugs 2006; 8 (3)

pg 174

2.3. Targeted Therapy

1652 adults
335 children
[147]


indicates 1,799 Burzynski patients

Is that what the FDA means by:

rely on … fewer patients?
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13. The FDA approved phase III (3) clinical trials for Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal); which means that they have shown evidence of effectiveness, yet they have NOT granted Accelerated Approval for them, even though they have done so for other treatments which had NOT yet published the final results of phase II (2) clinical trials, and which did NOT have as good Complete Response, Partial Response, Stable Disease, Minor Response, Progressive Disease, Objective Response, Progression-Free Survival, etc., rates:

Burzynski: Why has the FDA NOT granted Accelerated Approval for Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal) ?:
https://stanislawrajmundburzynski.wordpress.com/2013/07/28/burzynski-why-has-the-fda-not-granted-accelerated-approval-for-antineoplastons-a10-astengenal-and-as2-1-astugenal/

(Additional QUESTIONS being added)

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References:

1.

Post #73 – Didymus Judas Thomas

At the Tu-Quack Center Oracles of Deny to Respond tree

1/30/2013

Post #52 – Orac

“You do realize that that means that the Mayo trial failed to find evidence of efficacy, just as I said, don’t you?”

“The default of a finding like that is that there is no evidence of efficacy, not that failure to have adequate numbers to show an effect means that there’s an effect there”

“If SRB wants to convince skeptics that his treatments work better than conventional therapy, let him publish the evidence in a peer-reviewed journal in a manner that it can be independently verified”

“Thus far, he has failed to do so.”

Orac, I thoroughly enjoyed; with a dismissive limp wrist, you posted:

“Burzynski naturally has lots of excuses for why the trial failed and tried to blame the investigators, but his complaints are not convincing.”
http://scienceblogs.com/insolence/2013/01/21/quoth-joe-mercola-i-love-me-some-burzynski-antineoplastons
Now, why don’t you tackle those ?’s?

1. “[T]he study tested a dosing regimen known to be ineffective.”

2. “[D]osages used in the study “were meant for the treatment of a single small lesion…”

3. “5 of the 6 evaluable patients had either multiple nodules or tumors larger than” said single small lesion.

4. “As the provider,” SRB “strongly suggested to the NCI that these patients receive a much higher dose, consistent with their greater tumor load.”

5. “[T]he study was closed when” SRB “insisted that the NCI either increase the dosage or inform the patients that the drug manufacturer believed that the treatment was unlikely to be effective at the dosages being used (letter to Dr M. Sznol, NCI, on 4/20/1995).”

6. “A review of the clinical data in the article … proves the validity of” SRB’s “position” per SRB

7. “Their study patients had extremely low plasma antineoplaston levels.”

8. SRB’s “phase 2 study dosage regimen produced plasma phenylacetylglutamine levels that are 35 times greater, phenylacetylisoglutamine levels 53 times greater, and phenylacetate levels 2 times greater than those reported…’”

9. “The clinical outcomes reported … based on their inadequate dosage schedule, differ dramatically from” SRB’s “phase 2 studies in which a higher dosage regimen was used.”

10. “They reported no tumor regression. In contrast, in 1 of” SRB’s “ongoing studies on protocol BT-9, 4 of 8 evaluable patients with astrocytoma had objective responses.’”

11. “The difference in outcomes is primarily due to the difference in dosage schedules,” per SRB

12. “Another factor that may have caused a lack of response in the study by … is that the duration of treatment was too brief.”

13. “Almost all the patients in their study received treatment for less than 30 days.”

14. “1 patient received only 9 days of treatment.”

15. “The current studies indicate that objective tumor responses are usually observed after 3 months of therapy.”

16. “An additional 8 months of treatment is usually needed to obtain a maximal therapeutic effect.”

17. “[A]mbiguities in the response evaluation and analysis in the article…”

a) “In 2 patients, tumor necrosis was attributed to “radionecrosis.””

b) “However, such an interpretation is clouded by the fact that antineoplaston-induced necrosis can be indistinguishable from radionecrosis.”

c) “Moreover, the analysis … could have highlighted the 2 patients with recurrent glioblastoma who survived for more than I year.”

d) “This is of interest because these patients typically have a life expectancy of 3 to 6 months.”

18. “It is regrettable that, at the time of the study … the sponsor, NCI, decided against the higher dosing regimen that I proposed and closed the study.”
https://stanislawrajmundburzynski.wordpress.com/2013/03/24/stanislaw-rajmund-burzynski-m-d-ph-d-and-freedom-of-speech/
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/
Post #85 – Orac – April 28, 2013

“Well, DJT tried to comment last night and got caught in the moderation trap.”

“I’m not letting DJT through.”

“He’s been banned for very good reason, and I will not rescind the ban.”
http://scienceblogs.com/insolence/2013/04/26/all-truth-comes-from-public-debate-a-corollary-to-crank-magnetism/
My below blog contained a copy of the comment I submitted to his blog:
https://stanislawrajmundburzynski.wordpress.com/2013/04/27/important-the-live-debate-a-film-producer-a-cancer-doctor-and-their-critics/
All Mr. Hinton would have to do is ask “Orac” to respond to my post 73 on his blog, and it would be all over, since “Orac” has adopted his “Hold the Mayo” attitude, and shows no indication that he would ever be brave enough to touch it with the proverbial ZZ Top

“Ten Foot Pole”

because he’s probably aware of what would happen if he did

One of “Orac’s” “Oracolytes” posted on Forbes (#Forbes):
onforb.es/11pwse9

http://t.co/vh3cgAR6hW
“I already offered you a forum on a science blog to debate with a real respected surgical oncologist, with a guarantee that he never moderates the “debate”.”
http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics
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/
This is Dr. David H. Gorski’s blog

Dr. Gorski censored (blocked) my comments

We are supposed to believe that he’s now NOT going to block someone’s comments???
http://scienceblogs.com/insolence/2013/04/26/all-truth-comes-from-public-debate-a-corollary-to-crank-magnetism/
#66 – Didymus Judas Thomas

IMPORTANT: The live “debate”-A Film Producer, A Cancer Doctor, And Their Critics | Didymus Judas Thomas’ Hipocritical Oath Blog

April 27, 2013

Your comment is awaiting moderation.

Seriously ? Gorski ? Let’s remember that it is YOU who would NOT answer my questions, and instead inacted your “Hold the Mayo” posture re post 73

Let’s review your

“deconstructed his “evidence” in depth before” claim

1/21/2013 Orac posted THIS blog:

“Quoth Joe Mercola:

I love me some Burzynski antineoplastons

Posted by Orac on January 21, 2013″

” … In particular, a multicenter phase II trial carried out by investigators at the Mayo Clinic was a big failure, with a median survival of 5.2 months in patients with anaplastic oligoastrocytoma, anaplastic astrocytoma, or glioblastoma multiforme that had recurred after radiation therapy”

“Burzynski naturally has lots of excuses for why the trial failed and tried to blame the investigators, but his complaints are not convincing”
http://scienceblogs.com/insolence/2013/01/21/quoth-joe-mercola-i-love-me-some-burzynski-antineoplastons
I challenged “Orac” about this and this reply was posted which included my point at the beginning of the reply:

1/29/2013

“An excellent explanation of how dubious Stanislaw Burzynski’s activities are”

Posted by Orac on January 28, 2013
http://scienceblogs.com/insolence/2013/01/28/an-excellent-explanation-of-how-dubious-stanislaw-burzynskis-activities-are
Post #52 – Orac

January 29, 2013

“CONCLUSION: Although we could not confirm any tumor regression in patients in this study, THE SMALL SAMPLE SIZE PRECLUDES DEFINITIVE CONCLUSIONS ABOUT TREATMENT EFFICACY.”

“You do realize that that means that the Mayo trial failed to find evidence of efficacy, just as I said, don’t you?”

“The default of a finding like that is that there is no evidence of efficacy, not that failure to have adequate numbers to show an effect means that there’s an effect there”

“If SRB wants to convince skeptics that his treatments work better than conventional therapy, let him publish the evidence in a peer-reviewed journal in a manner that it can be independently verified”

“Thus far, he has failed to do so”

I responded to Orac, quoting his reply at the beginning of my reply:

Post #73 – Didymus Judas Thomas

At the Tu-Quack Center Oracles of Deny to Respond tree

January 30, 2013

Post #52 – Orac

“You do realize that that means that the Mayo trial failed to find evidence of efficacy, just as I said, don’t you?”

“The default of a finding like that is that there is no evidence of efficacy, not that failure to have adequate numbers to show an effect means that there’s an effect there”

“If SRB wants to convince skeptics that his treatments work better than conventional therapy, let him publish the evidence in a peer-reviewed journal in a manner that it can be independently verified”

“Thus far, he has failed to do so”

Orac, I thoroughly enjoyed; with a dismissive limp wrist, you posted:

“Burzynski naturally has lots of excuses for why the trial failed and tried to blame the investigators, but his complaints are not convincing.”
http://scienceblogs.com/insolence/2013/01/21/quoth-joe-mercola-i-love-me-some-burzynski-antineoplastons
Now, why don’t you tackle those ?’s?

[SOURCE: Feb. 1999 Mayo Clinic Publication pg 2, 3 PDF]
http://burzynskimovie.com/images/stories/transcript/Documents/Feb99MayoClinicPubANP.pdf
2/1999 – A10 and AS2-1 – Phase II – Mayo Clinic Proceedings http://www.ncbi.nlm.nih.gov/m/pubmed/10069350
Phase II Study of Antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in Patients With Recurrent Glioma Objective:
http://www.mayoclinicproceedings.org/article/S0025-6196(11)63835-4/fulltext
To assess the pharmacokinetics, toxicity, and efficacy of antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261)
http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)63835-4
Design:
http://www.sciencedirect.com/science/article/pii/S0025619611638354
We initiated a phase II trial in order to determine whether evidence of antitumor activity of A10 and AS2-1 could be documented
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS0025619611638354.pdf
Comment in Jun; 74 (6): 641-2
http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.2003.01098.x/full
Mayo Clin Proc 74(2):9 (1999)
http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.2003.01098.x/references
1999 Elsevier Ltd.
http://onlinelibrary.wiley.com/store/10.1046/j.1365-2796.2003.01098.x/asset/j.1365-2796.2003.01098.x.pdf?v=1&t=hbs6xce2&s=3423e3cd1955667e8e8cdf33323faf0bd85b6a29
DOI: 10.4065/74.2.137
http://onlinelibrary.wiley.com/store/10.1046/j.1365-2796.2003.01098.x/asset/j.1365-2796.2003.01098.x.pdf?v=1&t=hbrndkdf&s=e0af2d3bfb13841852d92a839d3a4932a5f4bb48
Mayo Clin Proc 1999; 74: 137–45

Burzynski responded by pointing out:

6/1999 – A10 and AS2-1 – SRB http://www.ncbi.nlm.nih.gov/m/pubmed/10377942
Efficacy of antineoplastons A10 and AS2-1
S R Burzynski
Mayo Clin Proc 74 (6): 641-2 (1999),
Mayo Clin Proc. 1999 Jun; 74 (6): 641-2 Comment on Mayo Clin Proc. 1999 Feb; 74 (2): 137-45 PMID .10377942 Elsevier Science
http://www.mayoclinicproceedings.org/article/S0025-6196(11)64143-8/fulltext
Mayo Clinic Proc. 1999; 74: 641–642 (letter) 74 (6): 641-2
http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)64143-8
Mayo Clin Proc 74 (6): 1 (1999), 1999 Elsevier Ltd.
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS0025619611641438.pdf
DOI: 10.4065/74.6.641

This was responded to:

6/1999 – Mayo Clin Proc 74(6):2 (1999), DOI: 10.4065/74.6.641-a
http://www.mayoclinicproceedings.org/article/S0025-6196(11)64144-X/fulltext
Mayo Clinic Proceedings
Volume 74, Issue 6 , Pages 641-642, June 1999
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS002561961164144X.pdf
References:

1. SAMID D , Shack S, Sherman LT. Phenylacetate: a novel nontoxic inducer of tumor cell differentiation. Cancer Res . 1992; 52:1988–1992
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/

http://m.cancerres.aacrjournals.org/content/52/7/1988.abstract

http://m.cancerres.aacrjournals.org/content/52/7/1988.full.pdf

http://cancerres.aacrjournals.org/content/52/7/1988
2. Danesi R, Nardini D, Basolo F, Del Tacca M, SAMID D . Myers CEo Phenylacetate inhibits protein isoprenylation and growth of the androgen-independent LNCaP prostate cancer cells transfected with the T24 Ha-ras oncogene. Mol Pharmacal. 1996; 49:972–979
http://www.ncbi.nlm.nih.gov/m/pubmed/8649357/

http://m.molpharm.aspetjournals.org/content/49/6/972.long
3. Chang SM, Kuhn LG, Robins HI, et al. Phase II study of phenylacetate in patients with recurrent malignant glioma: a North American Brain Tumor Consortium report. J Clin Oneal. 1999; 17:984–990
http://www.ncbi.nlm.nih.gov/m/pubmed/10071293/

http://m.jco.ascopubs.org/content/17/3/984.long
4. Thibault A, Cooper MR, Figg WD, et al. (SAMID D). A phase I and pharmacokinetic study of intravenous phenylacetate in patients with cancer. Cancer Res. 1994; 54:1690–1694
http://www.ncbi.nlm.nih.gov/m/pubmed/8137283/

http://m.cancerres.aacrjournals.org/content/54/7/1690.abstract

http://m.cancerres.aacrjournals.org/content/54/7/1690.full.pdf

http://cancerres.aacrjournals.org/content/54/7/1690
PII: S0025-6196(11)64144-X

doi: 10.1016/S0025-6196(11)64144-X

1999 Mayo Foundation for Medical Education and Research.
Elsevier Inc.

The above four (4) references in the response to Burzynski might be relevant if all that antineoplastons consisted of was phenylacetate

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

Antineoplastons AS2-1 and AS2-5 are DERIVED FROM A10

AS2-1=4:1 mixture of PHENYLACETIC ACID (PA) and Phenylacetylglutamine (PAG or PG)

National Cancer Institute (NCI) at the National Institutes of Health (NIH)
Antineoplastons
General Information:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page2
This is “what would happen” if “Orac” did have the “Bravery,” “Courage,” “Gumption,” “Intestinal Fortitude,” “Testicular Fortitude,” to address this issue:
http://burzynskimovie.com/images/stories/transcript/Documents/BurzynskiTriesToExposeNCI.pdf
Burzynski: Managing social conflict in complementary and alternative medicine research: the case of antineoplastons:
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-managing-social-conflict-in-complementary-and-alternative-medicine-research-the-case-of-antineoplastons/
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2.
Antineoplastons: Phenylacetylglutaminate (PG or PAG), Phenylacetate (PN), and Phenylbutyrate (PB):
https://stanislawrajmundburzynski.wordpress.com/2013/06/17/phenylacetylglutaminate-pg-or-pag-phenylacetate-pn-and-phenylbutyrate-pb/
Phenylacetylglutamine (PG or PAG):
https://stanislawrajmundburzynski.wordpress.com/2013/06/18/phenylacetylglutamine-pg-or-pag/
Phenylacetate (PN):
https://stanislawrajmundburzynski.wordpress.com/2013/06/18/phenylacetate-pn/
Phenylbutyrate (PB):
https://stanislawrajmundburzynski.wordpress.com/2013/06/18/phenylbutyrate-pb/
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