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]:
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1:58:04
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“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
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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:
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$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)
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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
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In connection with illegal promotion of pharmaceutical drug
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Pleading guilty to criminal count of violating Food, Drug, and Cosmetic Act by misbranding drug
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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
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Plea agreement signed by Lilly and United States

Complaint for permanent injunction

Consent decree of permanent injunction signed by company and United States
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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.”
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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?:
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https://stanislawrajmundburzynski.wordpress.com/2013/11/13/httpcancer-orgacsgroupscontentepidemiologysurveilancedocumentsdocumentacspc-036845-pdf/
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[3] – 12/21/2006 – On the messiness of evidence-based medicine
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http://scienceblogs.com/insolence/2006/12/21/the-messiness-of-evidencebased-medicine/
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[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
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[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
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[6] – 9/17/2007Evista Approved for Reducing Breast Cancer Risk:
——————————————————————
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048474.htm
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[7] – 2007
——————————————————————
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020815s018lbl.pdf
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[8]
——————————————————————
http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088593.pdf
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[9] – 2007
——————————————————————
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022042lbl.pdf
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[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/
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[11] – 11/4/2013
——————————————————————
http://www.justice.gov/opa/pr/2013/November/13-ag-1170.html
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Critiquing: Doctor accused of selling false hope to families (USA TODAY NEWS, NATION, Liz Szabo, USA TODAY)

20131116-002847.jpg
I gave Liz Szabo and USA TODAY the chance to act like a Spike Lee joint and “Do the Right Thing”, the same day their article came out [1]

I gave them the opportunity to prove that their article was a legitimate piece of journalism with some semblance of integrity, and NOT just akin to one of “The Skeptics™ phoned-in “rubber-stamped” yellow journalism hit pieces

Instead, it seems that Liz Szabo and / or USA TODAY decided to act as if they had rolled a Spike Lee joint

I sent an e-mail with 2 editorial corrections, and only one (correcting Lisa Merritt’s comment
link from taking the reader to the 1999 Mayo Clinic report instead of to her comments), was corrected [2]

The 2nd correction which they #FAILED to do, earns them well deserved INSOLENCE
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The article claims:
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Burzynski, 70, calls his drugs “antineoplastons” and says he has given them to more than 8,000 patients since 1977.”
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20131116-004037.jpg
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However, if you select the “8,000 patients” link, the referenced page does NOT indicate that at all [2]
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20131116-064344.jpg
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It advises:
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“That same year, Dr. Burzynski founded his clinic in Houston where he’s since treated over 8,000 patients.” [3]
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20131116-064326.jpg
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Nowhere does it indicate that he “treated 8,000 patients” with antineoplastons
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20131116-064409.jpg
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The question that Liz Szabo and USA TODAY should answer, is:

1. Who is your “fact-checker”, and
2. are they smarter than a 5th grader ?
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In fact, Burzynski’s 2002 Securities and Exchange Commission (SEC) filing advises:

” … in 1997, his medical practice was expanded to include traditional cancer treatment options such as chemotherapy, gene targeted therapy, immunotherapy and hormonal therapy in response to FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in the Company’s Antineoplaston clinical trials” [4]
——————————————————————
The article continues:
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“Individual success stories can be misleading, said Arthur Caplan, a professor and head of the division of bioethics at NYU Langone Medical Center”
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The question Arthur Caplan should be asking is:

Why has the United States Food and Drug Administration required Burzynski’s clinical trial patients to fail conventional therapies; such as surgery, chemotherapy, and radiation, BEFORE they are allowed to be treated with antineoplaston therapy ?

If the F.D.A. did NOT impose these restrictions upon Burzynski’s clinical trials, then the question Arthur Caplan raises would be moot
——————————————————————
The article quotes Dr. Jan Buckner as saying:
——————————————————————
“When I hear a story that is way out of the norm, the first question I ask is,

‘OK, is the diagnosis even correct?‘ ”

Buckner said”

“If the diagnosis wasn’t right to start with, it doesn’t matter what the treatment was.”

“Brain tumors are notoriously difficult to diagnose, Buckner says”

“When dealing with rare brain cancer, doctors may disagree about how to interpret imaging results up to 40% of the time”
——————————————————————
I wonder if Dr. Jan Buckner would agree with David Gorski; who is a BREAST cancer oncology specialist, and NOT a BRAIN cancer oncology specialist, who has the presumptiveness to speculate that 3 different medical opinions could have misdiagnosed Tori Moreno in August 1998; who was diagnosed with a very large tumor, about 3 inches in the largest diameter and located in the brain stem, which was too risky for surgery, and about which her parents were told by ALL 3, that Tori’s brain cancer was fatal and, she would die in a few days or at the most, 2-6 weeks, and that there was nothing that could be done, and was finally put on Burzynski’s antineoplaston therapy in October, when she was about 3 ½ months old, and in such condition that they were afraid that she might die at any time, David H. Gorski, M.D., Ph.D., FACS; who claims, “I do know cancer science” , has the audacity, because of his “book learnin'” has the temerity to postulate his “science-based medicine theory” that Miller’s Children at Long Beach Memorial misdiagnosed Tori Moreno’s inoperable stage 4 BSG

David Gorski has the gall to profer that City of Hope misdiagnosed Tori Moreno’s inoperable stage 4 brain stem glioma

David Gorski has the chutzpah to pontificate that Dr. Fred Epstein in New York misdiagnosed Tori Moreno’s inoperable stage IV brainstem glioma [5]
——————————————————————
The article then quotes Peter Adamson, chair of the Children’s Oncology Group:
——————————————————————
“But these therapies may have delayed benefits, taking weeks or months to shrink a tumor

“So patients treated by Burzynski may credit him for their progress, just because he was the last doctor to treat them, says Peter Adamson, chair of the Children’s Oncology Group, an NCI-supported research network that conducts clinical trials in pediatric cancer

Conventional cancer treatment can also cause tumors to swell temporarily, due to inflammation

“A patient who isn’t familiar with this phenomenon may assume her tumor is growing

“When that swelling subsides, patients may assume it’s because of Burzynski, Adamson says”
——————————————————————
This is laughable

In support of this “phenomenon” , the article provides a link to a Canadian web-site [6]

The site posits:
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“RT/TMZ is now widely practiced and the standard of care for appropriately selected patients, we are learning more about the consequences of RT/TMZ”

“One phenomena, termed Pseudo-Progression (psPD)…”
——————————————————————
The problem is that this only applies to “Glioblastoma Multiforme (GBM)”, and the article provides NO proof whatsoever, that any of Burzynski’s “Glioblastoma Multiforme (GBM)” patients have taken “RT/TMZ”
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Additionally, the site cites the reference as:

Sanghera, Perry, Sahgal, et al., “Sunnybrook Health Sciences Odette Cancer Centre” (in press, Canadian Journal of Neuroscience)

(“In press” refers to journal articles which have been accepted for publication, but have not yet been published)

However, the journal article in question was published 1/2010, so it has NOT been “in press” for over 3 years and 7 months [7]

Get your act together, aye, Canada !
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The article rants and raves on and on about FDA inspection reports from as far back as 1998, but at least they did quote Richard A. Jaffe:

“In Burzynski’s defense, Jaffe notes that inspection reports represent preliminary findings

“The FDA has not yet issued final conclusions”
——————————————————————
The article posts this ridiculous claim:
——————————————————————
“Yet the National Cancer Institute says there is no evidence that Burzynski has cured a single patient, or even helped one live longer
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That’s NOT what this seems to suggest [8]
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Then the article quotes pediatric oncologist Peter Adamson, a professor of pediatrics and pharmacology at Children’s Hospital of Philadelphia