Turkey Lurkey Thanksgiving Title

Traditionally, Thanksgiving is best known as the Holiday that the Detroit Lions get the “stuffing” knocked out of them

However, this year, it’s time to tender the tainted twisted trophy of Thanksgiving Turkey-Lurkey to Detroit’s toasted triumvirate treat of two-faced twerk-salad troll turpitude, and I have the temerity to tinker and tamper until I pay tribute with therapeutic levels of Thoreauness in response to GorskGeek’s misinformation, disinformation, and MisDisInformation (Missed ‘Dis Information)

Wednesday, 12/21/2005, Indianapolis, Indiana-based Eli Lilly and Company was treated to truthification, in connection with their illegal promotion (misbranding) of pharmaceutical drug EVISTA; (FDA approved for prevention and treatment of osteoporosis in post-menopausal women), in the:

a. prevention in risk of breast cancer

b. reduction in risk of breast cancer

Alleged in information, promoted drug as effective for reducing risk of breast cancer EVEN AFTER PROPOSED LABELING FOR THIS USE SPECIFICALLY REJECTED by FDA [1]

GorskGeek, being the breast cancer oncology specialist he claims to be, and so concerned about breast cancer patients that he is that “guy” who speaks out passionately about issues like the 10-year American Cancer Society Cancer Facts & Figures, “Estimated Breast Cancer Deaths for Women”, which reflect that in 2002, 39,600 (15%) women were estimated to die from breast cancer, and this year, 2013, the estimate is 39,620 (14%), which is 20 women MORE than 10-years ago, and who rails tirelessly about the ACS’s “Estimated New Breast Cancer cases in Women”, which 10-years ago was 203,500 (31%) in 2002, and now, in 2013 is 232,340 (29%), which is ONLY
28,840 MORE
than 10-years ago [2]

Now THAT’s progress !

GorskGeek, of course, must accomplish all this under his breath

But I’m sure you’re wondering, dear reader, what was GorskGeek’s outraged blog about this American pharmaceutical manufacturer coughing up $36 MILLION ?

Well, let me tell you … just as soon as I find it

Wait for it

Wait for it

Wait for it

GorskGeek was unable to bring himself to blog about Evista until exactly one year later, on 12/21/2006, and even then, he was “mum’s the word” about the breast cancer claims [3]

Perhaps GorskGeek just “knew” that eventually Evista would finally be approved by the FDA for Eli Lilly’s preventing or reducing risk of breast cancer claims on 9/13/2007, and who were those paper-pushing FDA apparatchiks to prevent Lilly from implementing their “Internal business plan” ? [4-9]

GorskGeek wouldn’t want to damage his slim and non-existent chance of getting some Eli Lilly money for research, by blogging anything that might in any way be possibly construed as him saying anything negatory about the BIG Pharma teat he longs to suck off of

After all, Bob ‘n’ Weave Blaskiewicz (who sees every molehill as a mountain), did say about GorskGeek, 9/28/2013 [10]:
——————————————————————
1:58:04
——————————————————————
“But he is a, the thing is, the thing is, you thing you have to understand is Gorski, Gorski is a genuine expert, in matters re re regarding on oncology studies

“I mean, he has a”

“He, He’s able to convince people, he’s able to convince people, on the strength of his record, to give him money to carry out research

“People who know what they’re talking about”

“To give him money to carry out his research”

“Right ?”
——————————————————————
1:59:00
——————————————————————
Yeah, right

Bobby 🙂

GorskGeek is hoping for a Happy Thanksgiving Golden Parachute; which is where he helps whistleblow about illegal BIG Pharma activity regarding some drug(s), which leaves him as the beneficiary of some funds like Mr. H. Dean Steinke, former Merck employee and his $68,190,000 MILLION from the federal government and states share of settlement amounts:
——————————————————————
$44,690,000 MILLIONMr. H. Dean Steinke, former Merck employee from federal share of settlement amount (1997 – 2001)
——————————————————————
$23.5 MILLIONMr. H. Dean Steinke, former Merck employee from the states share of settlement amount (1997 – 2001)
——————————————————————
Next, GorskGeek goes off on his fave autism prescription antipsychotic drug Risperdal, and the 11/4/2013, Monday, allegations concerning Global health care giant Johnson & Johnson (J&J) and its subsidiaries, $2.2 BILLION + fine regarding J&J Subsidiary Janssen (1999 – 2005) actions [11]
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REFERENCES:
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[1] – 12/21/2005
——————————————————————
EVISTA (FDA approved for prevention and treatment of osteoporosis in post-menopausal women)
——————————————————————
Eli Lilly and Company, Indianapolis, Indiana-based company
——————————————————————
12/21/2005, Wednesday
——————————————————————
$36 MILLION
——————————————————————
In connection with illegal promotion of pharmaceutical drug
——————————————————————
Pleading guilty to criminal count of violating Food, Drug, and Cosmetic Act by misbranding drug
——————————————————————
In addition to criminal plea
agreed to settle civil Food, Drug, and Cosmetic Act liabilities by entering into consent decree of permanent injunction
——————————————————————
Charged in criminal information filed with violation of Food, Drug, and Cosmetic Act, following investigation by Food and Drug Administration’s (FDA) Office of Criminal Investigations
——————————————————————
Plea agreement signed by Lilly and United States

Complaint for permanent injunction

Consent decree of permanent injunction signed by company and United States
——————————————————————
Information alleges 1st year’s sales of drug in U.S. were disappointing compared to original forecast
——————————————————————
According to information
10/1998 – company reduced forecast of drug’s 1st year’s sales in U.S. from $401 million to $120 million
——————————————————————
Internal business plan noted:

“Disappointing year versus original forecast.”
——————————————————————
Information alleges in order to expand sales of drug, Lilly sought to broaden market for drug by promoting it for unapproved uses
——————————————————————
Information alleges strategic marketing plans and promotion touted drug as effective in preventing and reducing risk of diseases for which drug’s labeling lacked adequate directions for use
——————————————————————
According to information: Evista
1. brand team
2. sales representatives
promoted drug for:
a. prevention in risk of breast cancer
b. reduction in risk of breast cancer
c. reduction in risk of cardiovascular disease
——————————————————————
Under provisions of Food, Drug, and Cosmetic Act, drug misbranded when labeling didn’t bear adequate directions for each of intended uses
——————————————————————
Alleged in information, promoted drug as effective for reducing risk of breast cancer even after proposed labeling for this use specifically rejected by FDA
——————————————————————
Information alleges executed illegal conduct using number of tactics, including:

1. One-on-one sales pitches by sales representatives promoting drug to physicians about off-label uses of drug

2. Sales representatives trained to prompt or bait questions by doctors in order to promote drug for unapproved uses

3. Encouraging sales representatives promoting drug to send unsolicited medical letters to promote drug for unapproved use to doctors on their sales routes

4. Organizing “market research summit’ during which drug was discussed with physicians for unapproved uses, including reducing risk of breast cancer

5.
a. Creating
b. distributing
to sales representatives “Evista Best Practices” videotape, in which sales representative states “Evista truly is the best drug for the prevention of all these diseases” referring to:

1). osteoporosis
2). breast cancer
3). cardiovascular disease
——————————————————————
Complaint for permanent injunction alleges executed illegal conduct using number of tactics, including:

1. Training sales representatives to promote drug for prevention and reduction in risk of breast cancer by use of medical reprint in way that highlighted key results of drug and thereby promoted drug to doctors for unapproved use

2. Some sales representatives were instructed to hide disclosure page of reprint which noted:

a. “All of the authors were either employees or paid consultants of Eli Lilly at the time this article was written,”

b. “The prescribing information provides that “The effectiveness of [Evista] in reducing the risk of breast cancer has not yet been established.””

3. Organizing “consultant meetings” for physicians who prescribed drug during which unapproved uses of drug discussed

4. Calculating incremental new prescriptions for doctors who attended Evista advisory board meetings in 1998

5. advisory board meetings included discussion of unapproved uses for drug

6. By measuring and analyzing incremental new prescriptions for doctors who attended advisory board meetings, Lilly was using this intervention as tool to promote and sell drug
——————————————————————
In addition to agreeing to plead guilty to criminal information and plea agreement signed by Lilly, settlement with United States includes following components:

(a) agreed to settle civil Food, Drug, and Cosmetic Act liabilities by entering into consent decree of permanent injunction

(1). As part of consent decree, agreed to comply with terms of permanent injunction, which will require company to implement effective training and supervision of marketing and sales staff for drug, and ensure any future off-label marketing conduct is detected and corrected

(2). agreed to be permanently enjoined from directly or indirectly promoting drug for use in:

a. preventing or reducing risk of breast cancer

b. reducing risk of cardiovascular disease

c. or for any other unapproved use in manner that violates Food, Drug, and Cosmetic Act unless and until FDA approves drug for additional use or uses
——————————————————————
(b) as part of consent decree, agreed to hire and utilize independent organization to conduct reviews to assist Lilly in assessing and evaluating Lilly’s

1. systems
2. processes
3. policies
4. procedures
relating to promotion of drug and company’s compliance with consent decree
——————————————————————
FDA made following announcement to postmenopausal women who have taken drug for prevention or treatment of osteoporosis:
——————————————————————
“No postmenopausal woman who has taken Evista for the prevention or treatment of osteoporosis is affected by this action, as this matter today relates only to unapproved uses of Evista.”
——————————————————————
Defendant agreed to plead guilty to charge in information
——————————————————————
Defendant agreed to resolve complaint for permanent injunction by agreeing to consent decree of permanent injunction
——————————————————————
http://www.justice.gov/opa/pr/2005/December/05_civ_685.html
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[2] – 11/13/2013 – The War on Cancer (I don’t think it means, what you think it says it means) #Winning?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/13/httpcancer-orgacsgroupscontentepidemiologysurveilancedocumentsdocumentacspc-036845-pdf/
======================================
[3] – 12/21/2006 – On the messiness of evidence-based medicine
——————————————————————
http://scienceblogs.com/insolence/2006/12/21/the-messiness-of-evidencebased-medicine/
======================================
[4] – 9/13/2007FDA Approval for Raloxifene Hydrochloride (Brand name(s): Evista®): Approved for breast cancer risk reduction:
——————————————————————
http://www.cancer.gov/cancertopics/druginfo/fda-raloxifene-hydrochloride
======================================
[5] – 9/14/2007FDA Approves New Uses for Evista: Drug Reduces Risk of Invasive Breast Cancer in Postmenopausal Women:
——————————————————————
http://www.fda.gov/newsevents/newsroom/pressannouncements/2007/ucm108981.htm
======================================
[6] – 9/17/2007Evista Approved for Reducing Breast Cancer Risk:
——————————————————————
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048474.htm
======================================
[7] – 2007
——————————————————————
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020815s018lbl.pdf
======================================
[8]
——————————————————————
http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088593.pdf
======================================
[9] – 2007
——————————————————————
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022042lbl.pdf
======================================
[10] – 10/18/2013 – Deconstructing Dr. David H. (Orac) Gorski – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/18/deconstructing-dr-david-h-orac-gorski-september-28-2013-the-skeptics-burzynski-discussion-by-bob-blaskiewicz-21951/
======================================
[11] – 11/4/2013
——————————————————————
http://www.justice.gov/opa/pr/2013/November/13-ag-1170.html
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A Message to Guy “Can’t Git-R-Done” Chapman

Guy “Crapman” Chapman is a SkeptiCoward©

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I’m NOT “Astroturfwatch” you twit
——————————————————————
“Guy” blogged another one of “The Skeptics™” #Fails [1]

He has a blog full of essentially misinformation, disinformation, misdirection, and lies regarding Burzynski, but the gist of it is that so far he has demonstrated to the entire world that he is that “Guy”, that “Yellow-Back” Chap, man, who has NOT demonstrated that he has the “Grapefruits”, to answer for his actions [2-4]

He claims my blog is “full of essentially incoherent commentary,” yet he offers NO explanation as to why it is that since its inception 2/14/2013, the Didymus Judas Thomas’ Hipocritical Oath Blog has had 9,626 visitors

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Where’s your stats, Guy ?

Lets “review” his latest piece of propaganda and Dezinformatsiya, shall we ?
——————————————————————
“The FDA approved a phase 3 trial, therefore Burzynski’s antineoplastons definitely work”
——————————————————————
#fail [5]

“[T]he emphasis in Phase 2 is on EFFECTIVENESS

“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2″
——————————————————————
“The Lancet rejected publication of the sole paper known to have been sumbitted from the one completed phase 2 trial, therefore there is a global conspiracy to suppress Burzynski”
——————————————————————
#Fail [6]

Bob Blaskiewicz postulated during the Google+ Hangout on Saturday, that this is a generic, usual, normal course-of-business rejection letter

NO such example is on Al Gore’s Internet

Whose got one ?

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Even in a Tweet, everybody must include all caveats and the full body of knowledge with footnotes, or stand convicted of lying
——————————————————————
#FaiL

Do NOT post deceptive Twits:

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#faIL

@SceptiGuy, on 5/25/2013, what did you NOT understand about her 5/23/2013 Cease and Desist Tweet ?

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A trial at a reputable cancer center once took several years to complete and publish, therefore failure to complete and publish a single trial in 40 years means nothing
——————————————————————
#FaiL

So, does this mean you wanted Burzynski to publish the phase 2 clinical trial final results before the trials were finished ?
——————————————————————
“Failure to participate on a partisan blog means you refuse to debate”
——————————————————————
#FAil [7]

Is this just another one of “The Skeptics™” Red Herring’s you like to use ?

The About page on my blog is crystal clear:

“The decision is that he is neither guilty nor innocent doesn’t mean he doesn’t need to do work within his practice, and the FDA obviously needs to pursue things as well

As I said on the Saturday Google+ Hangout, I consider myself to be a Skeptic Skeptic [8]

In other words, if you are going to be a true Skeptic, at least police yourself and “fact-check” before you insert foot-in-mouth and spread misinformation, disinformation, misdirection, and / or lies all over social media

Making lame excuses for NOT debating on my blog is like an atheist stating that they would NOT debate on Earth because creationists claim it was created by God
——————————————————————
“Failure to complete and publish trials is the single biggest reputational issue Burzynski has and it cannot be waved away or covered with a fig leaf of a single rejected paper”

“If you can’t understand why this is a problem, then we’re all wasting our time even talking to you”
——————————————————————
#FaIL [9]

YOUR failure to provide any citation(s), reference(s), and / or link(s) from the Declaration of Helsinki, United States Food and Drug Administration, National Cancer Institute (NCI) at the National Institutes of Health (NIH), or any other source to support your claim as to when you think Burzynski is required to publish, says it all
——————————————————————
“The average time from commencement of a trial to completion is 3-5 years”

“If a trial is going to be completed and published, very few take longer than 8 years to final publication”
——————————————————————
3/29/1996, then United States Food and Drug Administration Commissioner, David Kessler told the American people [10]:

2. The … FDA’s initiatives … will allowthe agencyto rely on smaller trialsfewer patients … if there is evidence … of partial response in clinical trials

A. What is the FDA’s definition of “smaller trials”?

B. What is the FDA’s definition of “fewer patients”?

Burzynski’s 2006 publication lists 1652 adults and 335 children (1,799 Total) [11]

20131003-184941.jpg
“A quick sample says that the first 60 of Burzynski’s phase 2 trials were all registered on the same day”

“1 November 1999, presumably following the consent decree which forbade him from administering antineoplastons outside of a registered clinical trial”
——————————————————————
fAil [11]

If you’re correct; which is rare, 3/29/1996, why did then US FDA Commissioner, David Kessler tell the American people [10]:

6. The uhh agency hasMANY … trials … has has approved trialsfor patientswith antineoplastons ?

Why does Burzynski’s 11/25/1997 SEC Form 10-SB filing list 72 phase 2 clinical trials ? [12]

Could it be because you are wrong ?
——————————————————————
“The trial that completed, was finished in February 2005”
——————————————————————
Are you certain ? [13]

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“The single phase 3 trial is withdrawn”
——————————————————————
Guy, did you contact the National Cancer Institute (NCI) at the National Institutes of Health (NIH) like I did, where they advised me: “Not every cancer clinical trial taking place in the United States is listed on our NCI Clinical Trials Database” ? [14]
——————————————————————
“I do not choose to debate on DJT’s blog”
——————————————————————
Guy, can you see the yellow stripe down your back ?

(I won’t say “spine,” because you haven’t shown that you have one)
——————————————————————
“He has a long history of misrepresenting differences of opinion as evidence of deceit (e.g. his claim that 0/61 is evidence that I can’t count, rather than what tit is, brevity during a rapid exchange of suggested questions during a Google hangout, where the person to whom the suggestion is made, is fully aware of the full context of 0/1/61 published/complete/registered”
——————————————————————
Guy, why don’t you just PROVE IT ?

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#fAiL

Guy, hasn’t ONE been completed ?

20131003-202310.jpg
You wanted him to publish before the clinical trials were finished ?
——————————————————————
“So that kind of stuff is not the actions of an honest broker”
——————————————————————
Guy, what do you call all of your above FAILS?
——————————————————————
“I wouldn’t expect DJT to debate here, nor would I be interested in giving him a platform; am happy to debate in an open forum where there are comprehensible questions and some sort of moderation to prevent tactics such as the Gish gallop”
——————————————————————
Talk about “Gish galloping”

First you post: I wouldn’t expect DJT to debate here … “

and then you posted: ” … nor would I be interested in giving him a platform …”

which just shows that you were NOT sincere when you posted your 1st comment

What you are basically saying when you posted: ” … I am happy to debate in an open forum where there are comprehensible questions and some sort of moderation to prevent tactics such as the Gish gallop, is that you are NOT competent enough to call “Gish gallop” and prove it during any debate

You want “Mommy” to protect you from someone who is more intelligent than you are ?

That’s what I hear you saying
——————————————————————
“Sorry, your blog is not an “open forum” and the majority of what’s written there is gibberish”
——————————————————————
I understand you

My blog is meant for intelligent people who can grasp ideas, dry wit, and other concepts humans use to communicate with each other

Unfortunately, I take it you are NOT like the other 9,600* people who have visited my blog
——————————————————————
“I recommend you stop trying to satirise someone else’s style and instead write in your own words”
——————————————————————
Why would I take any advice from you ?

You’re one FAIL after another

I’ll satirize (and spell it correctly) that Ph.D. FAIL “Orac” all I want
——————————————————————
“And read them back, if necessary to a friend, so that you get the general air of “what the hell does that even mean?””

“knocked out of it”
——————————————————————
It’s readily apparent who needs to check them self

Because you act as if you’ve been “knocked out of it” for quite some time

Maybe you should wear a helmet
——————————————————————
“Twitter is about rapid-fire debate”
——————————————————————
What the problem is ?

“The Skeptics™” think Twitter is a “debate forum”, but you do NOT have the cranial capacity to “debate”

What “The Skeptics™” do is called “mental bastardization”
——————————————————————
“Don’t pretend that any statement is ever intended to be a nuanced and scientifically rigorous statement of the prevailing consensus view, because it isn’t, and it’s not pretending to be”
——————————————————————
As far as I’m concerned, the vast majority of your twits are “pretending”
——————————————————————
“It’s fair to ask for a source or a clarification, it’s grossly misleading to cherry-pick individual tweets and misrepresent a lack of detail as deliberate malfeasance”
——————————————————————
The FACT is, a plethora of your twittering has as its source, your posterior
——————————————————————
“That’s the kind of tactic that gets you ignored and dismissed as a mendacious time-sink; if that’s the image you’re striving for then fine but I don’t think it is”
——————————————————————
Everyone already knows what you are

Guy “Crapman”
——————————————————————
“There you go”
——————————————————————
I could NOT have said it better myself
——————————————————————
“And now, if you don’t mind, I will get on with other things”
—————————————————————
LIKE THIS ?

EXPLAIN THIS [15]

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Prove I spammed 🙂

Are you a man ?

Or are you a

SkeptiCoward© ?

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REFERENCES:
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[1] – 10/2013 – A Message to DJT
——————————————————————
http://t.co/Rd9CVSaKcq
——————————————————————
http://www.chapmancentral.co.uk/blahg/2013/10/a-message-to-a-djt/
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[2] – 3/24/2013 – Critiquing “Burzynski: Another fact-blind troll, who predicted that?”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/24/critiquing-burzynski-another-fact-blind-troll-who-predicted-that/
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[3] – 4/12/2013 – The dishonesty of Guy Chapman, “The Skeptics” shill:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/12/the-dishonesty-of-guy-chapman-the-skeptics-shill/
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[4] – 5/5/2013 – guychapman (Guy Chapman) Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 9):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/05/05/guychapman-guy-chapman-critiquing-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics-page-9/
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[5] – 4/25/2013 – 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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[6] – 9/30/2013 – Bob Burzynski Skeptic Sez Multiforme Manuscript Meme Message Memorable:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/30/bob-burzynski-skeptic-sez-multiforme-manuscript-meme-message-memorable/
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[7] – About | Didymus Judas Thomas’ Hipocritical Oath Blog
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/about/
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[8] – 10/3/2013 – “The Skeptics™” Definition of “Debate”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/03/the-skeptics-definition-of-debate/
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[9] – 4/25/2013 – Burzynski: Declaration of Helsinki:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-declaration-of-helsinki/
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[10] – 6/8/2013 – 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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[11] – Treatments for Astrocytic Tumors in Children: Current and Emerging Strategies. Pediatric Drugs 2006;8:167-178. (Pediatr Drugs 2006; 8 (3)), 2.3. Targeted Therapy, pg. 174
——————————————————————
8/21/2013 – Critiquing David H. Gorski, MD, PhD, FACS http://www.sciencebasedmedicine.org/editorial-staff/david-h-gorski-md-phd-managing-editor/
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/21/critiquing-david-h-gorski-md-phd-facs-www-sciencebasedmedicine-orgeditorial-staffdavid-h-gorski-md-phd-managing-editor/
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[12] – 7/9/2013 – Burzynski: The Original 72 Phase II Clinical Trials:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/09/burzynski-the-original-72-phase-ii-clinical-trials/
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[13] – 6/26/2013 – Burzynski: The Clinical Trials:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/26/burzynski-the-clinical-trials/
——————————————————————
http://clinicaltrials.gov/archive/NCT00003509/2009_05_26/changes
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[14] – 4/26/2013 – Burzynski: Not Every Cancer Clinical Trial Taking Place In The United States Is Listed On Our NCI Clinical Trials Database:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-not-every-cancer-clinical-trial-taking-place-in-the-united-states-is-listed-on-our-nci-clinical-trials-database/
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[15]
——————————————————————
http://www.ncbi.nlm.nih.gov/pubmed/23408699/
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