Tag Archives: small

Pete Cohen films Pat and Steve Clarkson

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Reply

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Pat Clarkson, and I come from Danville, California, which is near San Francisco, and I have multiple myeloma; which is not a common cancer
About 20,000 people in the United States have the disease, and about 10,000 die every year, and 10,000 get the disease
So it’s a relatively small number of folks,that have it
So it’s not well
It’s not as well researched as some of the other cancers, um, but we’re hoping that the, um, Burzynski Clinic can help me

There’s not much hope for me
I, I have probably, a, uh, prognosis of a couple, couple years
Maybe a year or two to live, um, without, um, without I, I, an alternative method of treatment, and that’s why
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If I could say this a little differently
The conventional medicine, or what we would call conventional medicine, which is, you know, chemotherapy, radiation, uh, surgery; which is not possible with, uh, multiple myeloma because there is no, no large tumor that can be surgically removed, uh, the doctors have told us basically there is no cure, and that, and I, I say doctors; this is our local oncologist, um, and the head of oncology at, um, University of California, San Francisco; which is a very well respected school, uh, hospital, that there is no, uh, no reasonable possibility of a cure
Um, by contrast, uh, Dr. Burzynski, we have found out, has, uh, cured several people with myeloma, and he’s cured many other people with different kinds of cancer
The problem is, uh, that the FDA in its wisdom, will not allow us to, uh, be treated with the, uh, antineoplastons that are the backbone of the Burzynski therapy
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Well they’ve told us that they don’t have evidence that it’s, um, that it’s an effective treatment
Uh, that, they don’t have evidence that it’s not, non-toxic; which in fact, uh, is incorrect because the FDA does have evidence that it’s non-toxic
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Through the Senator’s office at the, the FDA is saying that they, they don’t know for sure that it’s not toxic; that’s not true, uh, and they don’t know that it will cure the disease, and therefor they can’t approve it
We’re willing
Pat’s willing to take the odds of a treatment, that is not 100% guaranteed, and let’s face it, most of the treatments that are approved by the FDA, are toxic, and are not guaranteed
So we don’t really understand, uh, why they have an issue with it, except that, uh, there’s an awful lot of money involved
Um, one of the peculiarities of the FDA, we understand they’re, by law, required to get much of their funding from the very companies that they’re supposed to be supervising

As, as I understand, uh, the Constitution, there is no basis in the Constitution for the Federal Government to be telling, an American, who they can use for a doctor or what drugs that they can use for, uh, their, their illness
Yet, over the years this, uh, this power has grown and been accepted at the FDA, and now it’s a, uh, uh, it’s, it’s out of control
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We have asked the FDA what is different about my case
Why I don’t get an exemption
We don’t have a response yet to that, to that question
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While doctors are generally very bright; they have to be to get through medical school, but they don’t have any training in critical, critical thinking, and most of them that I run into are not particularly good critical thinkers
The world they live in is to memorize a set of symptoms, then to look up or remember what those symptoms suggest in terms of a disease, and then remember or look up what the treatment is

So, here we have, um, uh, Dr. Burzynski, who is also a Ph.D biochemist, which is a, a interesting and, and very useful, uh, combination, who discovered that, um, in people who have cancer, they generally don’t have, or they have very reduced levels of what he now calls, uh, antineoplastons, and neoplaston is simply the medical jargon for cancer; so it’s anti-cancer, in effect, um, he discover the people who, uh, don’t have cancer, do have, high levels of this, and determined from research that these are controlled by, um, by the genes, and it’s part of the body’s immune system, in effect
We all produce cancer cells everyday of our lives
Like we produce bac, or have bacteria in our gi, digestive tract, that is controlled, by certain genes
In this case, um, he discovered that by, uh, by injecting, uh, or infusing, uh, these, they’re called peptides, peptide, that the patient could be helped
How, how innocuous, or how anti-toxic, can you have
It’s a, it’s a substance th, the body itself produces, unless the genes have shut down
Which is the case in, uh, some, in most, or at least half I guess, of multiple myeloma cases
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My, my message would be that they don’t have the right to tell me to hold a, a life or a death, um, decision
They, they don’t have the right to tell me that, um, I can’t have treatment that I seek, or I will die
I don’t think they have that right to do that
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Treatment is available
Uh, it is our choice
We are free Americans
We’re well informed
Uh, well educated
It should be our choice, and the Federal government in any, in any form should not have the authority to interfere with that
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Uh, nothing’s guaranteed in this world, um, but we’ve got, um, we’ve got some confidence in this clinic and in this treatment
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Pat & Steve Clarkson
January 27, 2012
Houston, Texas
6:25
2/3/2012
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Wikipedia or Wikipediantic ? – wants your 3 pounds of flesh (WikiPEEdia, UR all INe)

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[WP:SOP] “Statement of principles from Wikipedia founder Jimbo Wales, as updated by the community since then. 7.”)

Due & undue weight: [3]

“The relative prominence of each viewpoint among Wikipedia editors or the general public is not relevant & should not be considered,”

[WP:NPOV] “History of NPOV:” (Content # 6, Note 3)

(Neutral Point of View)
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TRANSLATION: Wikipedia editors, YOUR OPINION IS NOT RELEVANT
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MEANING: It is meaningless to attempt to slather your biased OPINION all over Wikipedia like butter on Texas toast, since supposedly, we only care about verifiable FACTS
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Wikipedia, what the problem is ?

Jimmy Donal Wales

Who ?

No, “The Who” is actually really British !

(as opposed to some “furreigner” who plops across the pond, wants to pound one of your pelts after a celebrity hunt, pops it in his bonnet, pip-pips about, and mounts it up on his rented wall along with what’s left of his balls)

I’m writing, of course, about “Jimbo,” the one who got away . . . Thankfully

The recipient of the write-up earlier this year in The New York Times [1] (Oh, pithy !!)
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Wales, who no longer runs the day-to-day operations of Wikipedia

“He applies his libertarian worldview to the Internet and has taken on institutions like the United States government“
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You must be bloody well right joking me

(joking me ? Quit jokin’ me !)

JimCrow’s ’bout as “libertarian” as Fidel Castro with a gun in his hand and (f)lies between his teeth; from traveling with the windows down

Stephen Colbert shoulda seen that comin’ from a 8 mile away

Hey Stephen, Report’ THAT !!!
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“He grew up in Huntsville, Ala., the son of a teacher and a retail man“
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And obviously, he didn’t “learnt” well

I think a refund’s in order

And here’s your free school Insolence to go with it

Happy eat in’

It is claimed that “HE” spends time:
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“traveling the world giving talks on free speech and Internet freedom“
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seriously ?

Seriously ??

SERIOUSLY ???

Welcome to MizFitTV

What would “Jymboree” know about “free speech” and “Internet freedom,“ anyway ?

How many days did you serve your country in the United States military ?

Oh, you did NOT realize that while you were in San Diego, you could have signed that contract ?

After all, he’s no Vincent Kennedy McMahon”
(“HE” knows where “HIS” GRAPEFRUITS are)
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“B.D.F.L., or the Benevolent Dictator for Life”
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How ’bout:

Big
Disappointing
Fascist
Loser ?
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“Argumentum ad Jimbonem” means dutifully following what Wales says, but there are even arguments about that”
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WP:NICETRY, but that’s “SHEEPLE”
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“One Wikipedia editor said, for instance, that Wales was no longer comfortable with the B.D.F.L. description”
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Jiminy Cricket !

Whazzamatta Jiminy?

Did “FASCIST” hit a bit too close to home ?
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“(There is, among some, a debate over what to call him)”

“Some users have also disputed the Latinized version of “Jimbo.”“

“(Should it be “Jimboni” or “Jimbini”?)”
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Can you smell what “The Rock” is cookin’ ?

La-La-La-La-Laaaaaaawwww, JIMBRONI !!!!!!!

Get ready, and bend over, ’cause I’m gonna shine this thing up, turn it sideways, and shove it straight up your Candy AstroTurf hatch
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Introduction (statement of principles) [WP:SOP]

“This is a statement of principles from Wikipedia founder Jimbo Wales, as updated by the community since then”
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(Or if you go by The New York Times article, [1] Jimbroni is the “co-founder” who tries to re-write history to make it appear that “HE” is the one-and-only Fascist Founder ?)
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“I should point out that these are my principles, such that I am the final judge of them”

“This does not mean that I will not listen to you, but it does mean that at some ultimate, fundamental level, this is how Wikipedia will be run”
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No, actually, it DOES mean that he will NOT listen to you, as was the case when he ignored my 2/7/2013 appeal

In his defense, perhaps Kate Garvey has his balls
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Principles

1. “Wikipedia’s success to date is entirely a function of our open community”

“This community will continue to live and breathe and grow only so long as those of us who participate in it continue to Do The Right Thing”

“Doing The Right Thing takes many forms, but perhaps most central is the preservation of our shared vision for the neutral point of view policy and for a culture of thoughtful, diplomatic honesty”
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The problem with this Wacky Tobacky “We are the (Wiki) World” WikiWhOReD Wonderland Jimbroni’s living in, is that “HE” has NOT been Doing The Right Thing since “HE” abdicated “his” “neutral point of view policy” and “culture of thoughtful, diplomatic honesty,” to “The Skeptics”

“The Skeptics,” who serve as gatekeepers of the Burzynski Clinic article, and who cite Dr. David H. Gorski a/k/a “Orac” aka GorskGeek as if he were a “reliable source”

“The Skeptics,” who bring new meaning to the term “Wikipedia Zero”

“The Skeptics,” who are Intellectual Cowards like their false god Gorski, the Closet Communist of Science-Based Medicine a/k/a Science-Basted Medicine aka Science-Based Mudicine (Spinning Bowel Movement), Wiki Wordsmith Wannabes, nut-jobbers, stale from their failure at the National Peanut Festival in Dothan, Alabama
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3. ““You can edit this page right now” is a core guiding check on everything that we do”

“We must respect this principle as sacred”
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Do the lies just dribble off your chin like phlegm?

You canNOT just go in and “edit” the Burzynski Clinic article “page right now”

That statement is pure, unadulterated Alabama B.S.

That’s NOT a “sacred principle,” it’s sacré “bull”
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7. “Anyone with a complaint should be treated with the utmost respect and dignity”
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Unfortunately, you do NOT practice what you preach, do you, HYPOCRITE ?
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“They should be encouraged constantly to present their problems in a constructive way”
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So that you can ignore the problem(s), right, Jimbroni ?
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“Anyone who just complains without foundation, refusing to join the discussion, should simply be rejected and ignored”
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THAT would automatically exclude all of “The Skeptics” now, wouldn’t it ?
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“We must not let the “squeaky wheel” be greased just for being a jerk”
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Jimbroni, why have you allowed “The Skeptics” to choose from their “squeaky” wheel-house bag o’ tricks, get all “greased” up and jerk” so many people around in such a big CIRCLE-JERK, for so long?
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8. “Diplomacy consists of combining honesty and politeness”

“Both are objectively valuable moral principles”

“Be honest with me, but don’t be mean to me”

“Don’t misrepresent my views for your own political ends, and I’ll treat you the same way”
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“Honesty” and “politeness” are really great “buzzwords,” Jimbroni, but they are as foreign to your “Skeptics,” as “moral principles”
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A great example of the questionable “honesty” and “moral principles” of one of your apparatchiks, was demonstrated 2/3/2013, 6:56, when I sent an arbitration appeal e-mail to Wikipedia, advising, in part, that the e-mail listed on Wikipedia; as the one that blocked users should use, did NOT work, because there was NO “@” sign in it

There was a . (period) where the “@” sign belonged
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2/3/2013, 8:11 AM, Anthony (AGK) BASC
 wikiagk@gmail.com advised:

“Everything you have said in that e-mail demonstrates a misunderstanding or misreading of Wikipedia policy”
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Check the “time” and “place” where you are, so that you, too, can advise, that according to Wikipedia, pointing out to them that the e-mail they advise people to use, DOES NOT WORK; because there is no “@” sign in it (instead, there’s a . (period)), translates into meaning:
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“Everything you have said in that e-mail demonstrates a misunderstanding or misreading of Wikipedia policy”
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Core principles

Wikipedia:Simplified ruleset [WP:SR]

Wikipedia does not have its own views, or determine what is “correct”
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I wish I could LIE like that, but I have a conscience
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12/24/2012, Monday – 3:52 pm – 21:52 (UTC) –
“We are told that 2013 will be a big year, but apparently his plan is to release another bullshit movie not to publish useful research”

[User Talk:JzG|Guy] ([User JzG/help|Help!]) [2]

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“Bullshit movie” ?
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Does anyone other than me NOT think it a “coinkydink” that some “Guy” on Wikipedia, going by the name “Guy”, using the same 2 words (“Bullshit movie”) as a “Guy” on Twitter ?
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2. Founding principles:

“Neutrality is mandatory . . . “
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I call B.S.

“Neutrality is mandatory,” EXCEPT on the Burzynski Clinic article, controlled by “The Skeptics”
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4. “Ignore all rules (IAR):”

“Rules on Wikipedia are not fixed in stone”
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Especially when Jimbroni allows “The Skeptics”
to “dictator” the “rules”
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“The spirit of the rule trumps the letter of the rule”

“The common purpose of building an encyclopedia trumps both”

“This means that any rule can be broken for a very good reason, if it ultimately helps to improve the encyclopedia”
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And “The Skeptics” are NOT required to provide ANY reason for having broken “any rule”
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“It doesn’t mean that anything can be done just by claiming IAR, or that discussion is not necessary to explain one’s decision”
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But do NOT expect Wikipedia to require anything from The Skeptics”
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Founding principles

1. “Neutral point of view (NPOV) as a mandatory editorial principle”
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EXCEPT when it comes to the Burzynski Clinic article
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12/26/2012 – I attempted to get Wikipedia to reference the interview which Burzynski’s attorney, Richard (Rick) A. Jaffe, and Lola Quinlan’s attorney; who posted it on his web-site, had given: [4]

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Please add re WP:NPOV that Burzynski’s attorney, Richard Jaffe has disputed Lola Quinlan’s claims:

“On February 1, 2012, Dr. Burzynski’s attorney, Richard Jaffe, disputed Lola Quinlan’s allegations on Houston’s KPRC News.”

Thank you very much.[[User: Didymus Judas Thomas 15:03, 12/26/2012 (UTC)
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So? [OR] Disputing it in the media probably means he doesn’t have a case. [/OR] In any case, a lawyer disputing the allegations against his client is not even news. — [[User: Arthur Rubin 15:24, 12/26/2012 (UTC)

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Arthur Rubin, I’m not sure what relevance your above post has re WP:NPOV since the article includes statements from attorneys representing both sides

17:51, 12/27/2012 (UTC) Didymus Judas Thomas

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12/24/2012, Monday – 3:54 pm (21:54.UTC) – “What they mean is that nobody else is doing any meaningful work on it, which necessarily means that it’s not considered in the least promising.”

[[User Talk:JzG|Guy]] ([User JzG/help|Help!])

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“Nobody else is doing meaningful work on it” ?

Ignores independent research done in Poland, Russia, Korea, Egypt, Japan, & China which specifically reference SRB’s publications in their publications re antineoplastons & phenylacetylglutamine (PG); which is AS2-5, & includes phase III trials published in China & continued research being published in China 12/17/2012?

FACTS:

1. I pointed out to Wikipedia, a 12/17/2012 scientific publication re antineoplastons, which referenced Burzynski @ 22. (antineoplaston AS21)

2. 7 days after this scientific journal was published, Wikipedia’a “Guy (Help!’s) ”response, Monday, 12/24/2012 @ 3:54 pm, is to advise me:

“What they mean is that nobody else is doing any meaningful work on it, which necessarily means that it’s not considered in the least promising.”

Guy (Help!) 3:54 pm, 12/24/2012, Monday

3. So, Wikipedia’s, Guy (Help!), defines an event having been published 7 days ago (12/17/2012 to 12/24/2012) as:

“…nobody else is doing any meaningful work on it…”

12/17/2012
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3524164
CDA-2 (cell differentiation agent 2), a URINARY preparation
http://po.st/g71N8P
CDA-2 and its main component PHENYLACETYLGLUTAMINE (PG or PAG)
Antineoplaston AS2-5 is PHENYLACETYLGLUTAMINE (PAG or PG)
http://redd.it/1dk974
Antineoplaston AS2-1 is a 4:1 mixture of phenylacetic acid (PA) and PHENYLACETYLGLUTAMINE (PAG or PG)
Antineoplastons AS2-5 and AS2-1 are derived from Antineoplaston A10
BURZYNSKI Reference: 22.
antineoplaston AS21
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0052117
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12/26/2012, Wednesday – 12:43 – “There is unlikely to be any dispassionate debate over ANPs while Burzynski continues with his unethical practices.”

JzG|Guy User:JzG/help|Help!

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Wikipedia: Judge, Jury, Executioner
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“The world, right now, considers Burzynski to be at best unethical and at worst a quack…”?

Since when did Wikipedia conduct a world-wide “opinion poll” re Burzynski ?

And if Wikipedia is correct, how did this happen ?

Burzynski referenced by other Cancer researchers:

2011 – Phase II trial of tipifarnib and radiation in children with newly diagnosed diffuse intrinsic pontine gliomas
http://neuro-oncology.oxfordjournals.org/content/13/3/298.full
University of California—San Francisco

Children’s Hospital Boston, Massachusetts

St Jude Children’s Research Hospital, Memphis, Tennessee

Seattle Children’s Hospital, Seattle, Washington

Children’s Hospital of Philadelphia, Pennsylvania

Children’s Hospital of Pittsburgh, Pennsylvania

Children’s National Medical Center, Washington, DC

Cincinnati Children’s Hospital Medical Center, Ohio

Neuro Oncol (2011) 13 (3): 298-306
doi: 10.1093/neuonc/noq202

5.723 Impact Factor

25. ↵ Burzynski SR
Treatments for astrocytic tumors in children: current and emerging strategies
Paediatr Drugs. 2006;8:167-178
http://link.springer.com/article/10.2165%2F00148581-200608030-00003
Pediatric Drugs
May 2006, Volume 8, Issue 3, pp 167-178
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Rhode Island Red attempts to get away with misquoting me:
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“The other argument is that the secondary sources (i.e., respected cancer organizations, FDA, etc.) are not reliable because they are Burzynski’s “competitors”

[[User: Rhode Island Red]] 4:18 pm, Yesterday (UTC−6)
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What a Wipocrite (Wiki + Hypocrite)

Steve Pereira (SilkTork) is such a “WIPOCRITE,” that he claims:
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“the community were united that your contributions were biased”
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He conveniently; like a good little mini-Jimbroni would, ignores ALL of his fellow WIPOCRITES comments, which completely ignored:
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([WP:SOP] “Statement of principles from Wikipedia founder Jimbo Wales, as updated by the community since then. 7.”)

Due & undue weight: [3]

“The relative prominence of each viewpoint among Wikipedia editors or the general public is not relevant & should not be considered,”

[WP:NPOV] “History of NPOV:” (Content # 6, Note 3)

(Neutral Point of View)
——————————————————————
1. 12/24/2012, Monday – 3:52 pm – 21:52 (UTC) – “We are told that 2013 will be a big year, but apparently his plan is to release another bullshit movie not to publish useful research”
——————————————————————
2. 12/24/2012, Monday – 3:54 pm (21:54.UTC) – “What they mean is that nobody else is doing any meaningful work on it, which necessarily means that it’s not considered in the least promising.”
——————————————————————
3. 12/26/2012, Wednesday – 12:43 – “There is unlikely to be any dispassionate debate over ANPs while Burzynski continues with his unethical practices.”
——————————————————————
4. 12/30/2012 8:58 “The world, right now, considers Burzynski to be at best unethical and at worst a quack…”?
——————————————————————
Am I NOT the only one convinced that “the community” was also “united” in something more than just their “goose-stepping ?
——————————————————————
Pereira, the imperfect ‘pedia Pimp tries to Wow his readers by waxing WikiWhOReD, by ignoring that ALL the previous BIASED opinion B.S. that his fellow-Facist forged ahead with, and which Wikipediantic history says means ABSOLUTELY NOTHING (say it again) because it is their BIASED OPINION and is ABSOLUTELY WORTHLESS, and it was as so much WikiLitter, well, he’s just facist-free speechless about that, as any Jimbroni AstroTurf Twerk should be
======================================
To show exactly what zealots these WikiPimps are, just absorb this exchange:
——————————————————————
“The Burzynski Clinic Article has:

“…a Mayo Clinic study found no benefit….”

But that was not what the study concluded

See below:
——————————————————————
“CONCLUSION:

Although we could not confirm any tumor regression in patients in this study, the small sample size precludes definitive conclusions about treatment efficacy.”
——————————————————————
In the interest of Neutrality, please remove the reference to Mayo entirely or change to;
——————————————————————
“…a Mayo Clinic study found that “the small sample size precludes definitive conclusions about treatment efficacy.”
——————————————————————
Thank you very much

Didymus Judas Thomas 21:12, 12/10/2012
——————————————————————
“How is “found no benefit” not a a fair and pithy description of the Mayo Clinic study’s summary?”

Alexbrn 21:24, 12/10/2012
——————————————————————
“I feel this should be changed under WP:NPOV because not every reader is going to understand the “Fair & Pithy” reason I was provided

I feel that the average reader reading this will read it as meaning a study was done & completed with the necessary # of people for an effective study, when that was not the conclusion as pointed out in my above post

Thank you very much.”

Didymus Judas Thomas 11:02, 12/18/2012
——————————————————————
NO RESPONSE

That’s right !

“NO RESPONSE” from the “mini-b” (a/k/a “mini-brain”), wannabe Fascists who are so zealous about using their alleged “Fair and Pithy” “found no benefit” WikiWhOReD; which they utilize in an effort to deceive those who are NOT smarter than a fifth-grader

These WikiPimps are so certain of the righteousness of their evangelical cause, that they do NOT even have the “GRAPEFRUITS” to use what the study’s conclusions actually said, and let the chips fall where they may

There are a lot of “chips” falling at Wikipedia

“BULL CHIPS”

JIMBRONI, you’re no Maggie Thatcher

You can’t even wear her pants
——————————————————————
Margaret Thatcher: “The Iron Lady”

Jimbroni: “No iron in the pants”
——————————————————————
Jimbroni’s list of Facist, mini-Hitler, Monty Pythonesque Women’s underwear wearing Wannabes on Wikipediantic:

1. Alexbrn
2. fluffernutter
3. NE Ent
4. Choyoołʼįįhí:Seb az86556 (Seb az86556)
5. Tom Morris
6. Guerillero
7. Dave Dial
8. John
9. Nstrauss
10. Yobol
11. Drmies
12. foxj
13. Ironholds
14. Rhode Island Red
15. Anthony (AGK) BASC wikiagk@gmail.com
16. Steve Pereira (Silk Tork) silktork@gmail.com
——————————————————————
WikiWhOReD (Wiki + Word + Whore): Pimping a word. Attempting to deceive someone by means of misdirection with words
——————————————————————
The South will rise again, just not in Jimbroni’s pants
——————————————————————
Happy Friday the 13th, Wikipediantic
======================================
REFERENCES:
======================================
[1] – 6/27/2013 – Jimmy Wales Is Not an Internet Billionaire (By AMY CHOZICK):
——————————————————————
http://mobile.nytimes.com/2013/06/30/magazine/jimmy-wales-is-not-an-internet-billionaire.html
======================================
[2] – 12/24/2012, Monday – 3:52 pm – 21:52 (UTC) – [User Talk:JzG|Guy] ([User:JzG/help|Help!])
——————————————————————
http://en.wikipedia.org/w/index.php?title=Talk:Burzynski_Clinic&diff=next&oldid=529537854
======================================
[3] – 12/26/2012 – Lola A. Quinlan:
——————————————————————
http://en.wikipedia.org/w/index.php?title=Talk:Burzynski_Clinic&diff=prev&oldid=529836971
——————————————————————
http://en.wikipedia.org/w/index.php?title=Talk:Burzynski_Clinic&diff=next&oldid=529836971
——————————————————————
Houston’s KPRC News:
——————————————————————
http://m.click2houston.com/news/Houston-cancer-doctor-draws-new-complaints-from-patients/-/16714936/8581480/-/hmrbjk/-/index.html
——————————————————————
Lola A. Quinlan’s attorney’s web-site:
——————————————————————
http://www.jag-lawfirm.com/burzynski-suit-kprc-02012012.html
======================================
[4] – –
——————————————————————
http://en.wikipedia.org/w/index.php?title=User_talk:Didymus_Judas_Thomas&diff=next&oldid=528610760
======================================

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These mini-b’s went so far as to allege all sorts of sockpuppetry

Wikipediantic, why don’t you list all the dates and times I was supposedly doing all of these activities; and don’t forget to include all the time I spent blogging, on Twitter, making comments on articles, etc., and once you have all that data compiled, explain how one individual could do all that in a 24-hour day

That’s right Wikipediantic

I’m challenging you to put up or shut up your cornholio

All’s fair in Drugs and War

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GlaxoSmithKline
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$3 BILLION
——————————————————————
7/2/2012
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(4/1998 – 8/2003)
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United States alleges GSK participated in
preparing
publishing
distributing
misleading medical journal article that misreported that clinical trial of drug demonstrated efficacy in treatment when study failed to demonstrate efficacy
——————————————————————
At same time, United States alleges, GSK didn’t make available data from 2 other studies in which drug also failed to demonstrate efficacy
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(2001 – 2007)
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United States alleges GSK failed to include certain safety data about drug in reports to FDA meant to allow FDA to determine if drug continues to be safe for approved indications and to spot drug safety trends
——————————————————————
missing information included data regarding certain post-marketing studies
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data regarding 2 studies undertaken in response to European regulators’ concerns about safety of drug
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United States alleges GSK stated drug had positive cholesterol profile despite having no well-controlled studies to support that message
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Johnson & Johnson (J&J) and subsidiaries, Janssen Pharmaceuticals Inc. and Scios Inc.
Janssen Pharmaceutica Products, L.P.
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$2.2 BILLION +
——————————————————————
11/4/2013, Monday
——————————————————————
Johnson & Johnson (J&J) and Janssen
——————————————————————
complaint alleges J&J and Janssen were aware drug posed serious health risks, but companies downplayed these risks
——————————————————————
For example, when J&J study of drug showed significant risk of strokes and other adverse events in patients, complaint alleges Janssen combined study data with other studies to make it appear there was lower overall risk of adverse events
——————————————————————
year after J&J received results of 2nd study confirming increased safety risk for patients taking drug, but hadn’t published data, one physician who worked on study cautioned Janssen
——————————————————————
“[a]t this point, so long after [the study] has been completed … we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”
——————————————————————
complaint alleges Janssen knew patients taking drug had increased risk, but nonetheless promoted drug as “uncompromised by safety concerns”
——————————————————————
When Janssen received initial results of studies indicating drug posed same risk as other antipsychotics, complaint alleges company retained outside consultants to re-analyze study results and ultimately published articles stating drug was actually associated with lower risk
——————————————————————
J&J and another of its subsidiaries, Scios Inc.
——————————————————————
8/2001 – FDA approved drug to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity
——————————————————————
approval based on study involving hospitalized patients experiencing severe heart failure who received infusions of drug over average 36-hour period
——————————————————————
complaint alleged Scios had no sound scientific evidence supporting medical necessity of outpatient infusions and misleadingly used small pilot study to encourage serial outpatient use of drug
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Abbott Laboratories Inc.
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$1.5 BILLION
——————————————————————
5/7/2012, Monday
——————————————————————
(2001 – 2006)
——————————————————————
company marketed drug in combination with atypical antipsychotic drugs even after its clinical trials failed to demonstrate adding drug was any more effective than atypical antipsychotic alone for that use
——————————————————————
1999 – forced to discontinue clinical trial of drug due to increased incidence of adverse events, including
somnolence
dehydration
anorexia
experienced by study participants administered drug
——————————————————————
funded 2 studies of use of drug
both failed to meet main goals established for the study
——————————————————————
When 2nd study failed to show statistically significant treatment difference between antipsychotic drugs used in combination with drug and antipsychotic drugs alone, waited nearly 2 years to notify sales force about study results and another 2 years to publish results
======================================

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AstraZeneca LP / AstraZeneca Pharmaceuticals LP
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$520 MILLION
——————————————————————
4/27/2010, Tuesday
——————————————————————
engaged doctors to conduct studies on unapproved uses of drug
——————————————————————
recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies doctors in question didn’t conduct
——————————————————————
then used
studies
articles
as basis for promotional messages about unapproved uses of drug
======================================
REFERENCE:
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11/26/2013 – United States Department of Justice (DOJ) versus BIG Pharma: BIG Pharma fought the law, and the law won ?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/26/united-states-department-of-justice-versus-big-pharma-big-pharma-fought-the-law-and-the-law-won/
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