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]:
“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 ?”
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]
[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
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

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
[2] – 11/13/2013 – The War on Cancer (I don’t think it means, what you think it says it means) #Winning?:
[3] – 12/21/2006 – On the messiness of evidence-based medicine
[4] – 9/13/2007FDA Approval for Raloxifene Hydrochloride (Brand name(s): Evista®): Approved for breast cancer risk reduction:
[5] – 9/14/2007FDA Approves New Uses for Evista: Drug Reduces Risk of Invasive Breast Cancer in Postmenopausal Women:
[6] – 9/17/2007Evista Approved for Reducing Breast Cancer Risk:
[7] – 2007

Click to access 020815s018lbl.pdf


Click to access ucm088593.pdf

[9] – 2007

Click to access 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
[11] – 11/4/2013

Critiquing: The Institute of Medicine report on cancer care: Is the system “in crisis”?

[1] – 9/19/2013 – “Americans love to fight, traditionally”

“All real Americans love the sting and clash of battle…When you, here, everyone of you, were kids, you all admired the champion marble player, the fastest runner, the toughest boxer, the big league ball players, and the All-American football players”

“Americans love a winner”

“Americans will not tolerate a loser”

– General George S. Patton, Jr., June.5, 1944

The above might as well be Greek to Dr. David H. Gorski a/k/a “Orac”

He’s the epitome of the word “loser”

Indeed, “Orac” described his work-place nemesis as “user hostile”

After 5 years, he still didn’t fully understand much of it, and he claims he’s not exactly computer illiterate

Gorski is that “guy” who couldn’t even find Burzynski’s publication:

[2] – 1997 – Burzynski. S.R. Antineoplastons. oncogenes and cancer

[3] – “Orac” batted the big “O” when he tried to find “the scientific rationale to expect that” antineoplastons “might have antitumor activity”

[4] – Gorski was geniusless when it came to finding “which genes are targeted by antineoplastons,“ proving that he really does NOT know Burzynski’s personalized gene-targeted therapy

In fairness, I will point out that he hasn’t put the time in to learn all the ins and outs of the system …

He pontidefecates about phase II clinical trials when his name isn’t even on a phase 2 trial, too

[5] – 9/19/2013 – He’s the “guy” who’s “mystified” as to how Stanislaw Burzynski “has managed to keep practicing for 36 years after he first began treating patients with an unapproved (not ordinary) chemotherapeutic drug (the concoction of peptides purportedly isolated from blood and urine that Burzynski dubbed “antineoplastons” because of their alleged ability to inhibit the growth of cancer)”

This is not an issue unique to Gorski; I’ve discussed other cases like this, such as Bobby Blaskiewicz, who used his man-crush relationship with Gorski to appear on the Skeptic Canary Show; Davey James, who was only recently stripped of his license to practice in several states of mind; Adam Jacobs, who went so far as to use his business influence to alter his Dianthus Mediclueless web-site in London to be more hack friendly, and an interventist who administered twerkpidity to posers who didn’t have common sense and defrauded minions for tens of millions of minutia

It’s a general problem

However, as far as doctors who should have been shut down a long time ago, “Orac” takes the cake

[6] – He has NOT yet figured out that Burzynski learned from the best

[7] – Who could do it better than someone like Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH) who Burzynski had to deal with:

“This is, as you point out, a most serious matter, and I was hoping that you could allay my concerns by showing me where they are unfounded

“However, your letter conspicuously fails to address them

“You also make reference to “numerous factual misstatements” but fail to identify any of them, much less provide documentation to show they are false”

Pg. 2

“I am glad that you plan to “thoroughly examine the accusations” I have made”

“I also eagerly await a substantiative response to the points raised in my letter of 4/20/1995”


After all, can we really take a person seriously, who claimed:
[8] – 11/2/2012 – “Personally, having pored over Burzynski’s publications … “
[9] – 5/8/2013 – “I’ve searched Burzynski’s publications … “
[10] – 6/5/2013 – “ … I do know cancer science”
Uhhhhhhh … yeah

But do you really know Burzynski’s cancer science when you did NOT even know:

“which genes are targeted by antineoplastons“?

Has “GOraCON” (“Orac” + @Gorskon) even read these ?
[11] – 10/2003 – Waldbillig R, Burzynski SR. Mechanism of action, uptake, and gene array studies on the antineoplastic agent phenylacetylglutamine (PG) in human glioma cells U-87. Neuro-Oncology. 2003; 5: 309

Volume 5 Issue 4 October 2003

(genes CD38, OASL, and TCF8)
[12] – 10/2007 – Patil, S., Burzynski, S.R., Mrowczynski, E., Grela, K. Phenylacetylglutamine (PG) and phenylacetate (PN) interact additively to produce detachment-induced apoptosis/anoikis in glioblastoma cells. Neuro-Oncology 2007; 9:482

Volume 9 Issue 4 October 2007

We have conducted a total human gene array screen using the Affymetrix Human Genome plus 2.0 oligonucleotide arrays, for genes regulated by PG and a combination of PG and PN

gene TXNIP was up-regulated almost 5-fold with PG, and almost 120-fold using a combination of PG and PN

genes that are significantly up-regulated are CLDND1, ATF3, CASP5, TP53, TRIB3, and UNC5B

Genes that were down-regulated include AKT2, ASPM, CDCA8

(caspase 5, p53, netrin receptor) and AKT pathway (AKT2, TRB3)
[13] – 10/2008 – Patil, S., Burzynski, S., Chittur, S., Mrowczynski, E., Grela, K. Antineoplaston AS2-1 affects cell cycle checkpoints, leading to apoptosis in human glioblastoma cells. Neuro-Oncology 2008; 10:786

Volume 10 Issue 5 October 2008

Affymetrix Human Genome

CDCs 25A and 25B, cyclins D3 and E, and CDKs 3, 4, and 6

ORC1L and CDC6

MCMs 2, 3, 4, 5, 6, and 7, and CDC7

cyclins A, B1, and B2, polykinase 1, and CDKs 1 and 2

MAD2L1, BUB1 and CDC20

p21, p53, and GADD45A

p21/CDKN1A, and PPM1A

Based on pathway analysis, it was observed that anti-neoplastons affected the expression of more than 40 genes instrumental in the cell cycle in GBM cells
[14] – 12/2008 – Patil, S., Burzynski, S., Chittur, S., Mrowczynski, E., Grela, K. The ingredients of antineoplaston AS2-1 down-regulate glycolysis pathways in glioblastoma cells. Neuro-Oncology 2008; 10:1148

Volume 10 Issue 6 December 2008

In 2004 the FDA granted orphan drug designation for antineoplastons A10 and AS2-1 for the treatment of brainstem glioma

12 FDA-supervised phase II clinical trials have confirmed anti-tumor efficacy in several types of brain tumors

A total human gene array screen using the Affymetrix Human Genome

The expression of mRNA for vitamin D3 up-regulated protein 1 (VDUP1) was found to be over 100 fold higher for cells treated with PG and PN

succinate dehydrogenase C (SDHC), fumarate hydrogenase (FH), succinate-CoA ligase 1 and 2 (SUCLG1and 2), and aconitase 2 (ACO2)
[15] – 11/2010 – Patil S, Burzynski SR, Mrowczynski E, Grela K. Targeting MicroRNAs in Glioma Cells with Antineoplastons. Neuro-Oncology 2010; 12, iv10

Volume 12 Supplement 4 November 2010

This study was done using the Dharmacon mRNA profiling array (Thermo Fisher Scientific)

mRNAs 125a-5p and 125a-3p

mRNAs 125a-5p has recently been shown to be regulated by the epidermal growth factor receptor and to function as a tumor suppressor in lung cancer

It has also been shown that the over-expression of mRNA 125a or mRNA 125b caused reduced migration and invasion of SKBR3 breast cancer cells

Using the total human microarray screen (Affymetrix)

[16] – 6/2012 – Sonali, S. Patil, Stanislaw R. Burzynski, Emilia Mrowczynski, Krzysztof Grela, Sridar V. Chittur. Phenylacetylglutaminate and Phenylacetate in combination Upregulate VDUP1, cause cell cycle blockade and Apoptosis in U87 Glioblastoma cells. Journal of Cancer Therapy 2012;3:192-200
[17] – 9/2012 – Patil, S., Burzynski S.R., Mrowczynski, E., Grela, K. P.003. Phenylacetylglutaminate in combination with Phenylbutyrate effectively inhibits growth of brain tumor cell In Vitro. Neuro-Oncology 2012;14(Suppl. 3):iii16

Volume 14 Supplement 3 September 2012

The FDA granted Orphan Drug designation for Antineoplastons A10 and AS2-1 for the treatment of gliomas, in 2009

12 FDA-supervised Phase II clinical trials have confirmed anti-tumor efficacy in several types of brain tumor


PG is not toxic to normal cells whereas PB has dose-limiting neuro-cortical toxicity
Cancer care: Is the system “in crisis” ?

The Institute of Medicine, just in case you’re like “Orac” and have NOT yet figured it out, “the system” has been “in crisis” since the Gubment “forgot” who they are here to serve

[18] – Gorsi, maybe you can explain to The Institute of Medicine why the Cancer care system is “in crisis” because M.D.’s with Ph.D’s who hold positions “at an NCI-designated comprehensive cancer center,”are responsible for massive fact-checking #FAILS

What did you do, Gorski ?

Phone It in again ?
[1] – 9/19/2013 – The Institute of Medicine report on cancer care: Is the system “in crisis” ?
[2] – 1997 – Critiquing: Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies:
[3] – Critiquing: Dr. David H. “Orac” Gorski and The Skeptics™