Pete Cohen films Pat and Steve Clarkson

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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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Advertisement

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 ?”
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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)
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$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
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EVISTA (FDA approved for prevention and treatment of osteoporosis in post-menopausal women)
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Eli Lilly and Company, Indianapolis, Indiana-based company
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12/21/2005, Wednesday
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$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
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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
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According to information
10/1998 – company reduced forecast of drug’s 1st year’s sales in U.S. from $401 million to $120 million
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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
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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
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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
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Under provisions of Food, Drug, and Cosmetic Act, drug misbranded when labeling didn’t bear adequate directions for each of intended uses
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Alleged in information, promoted drug as effective for reducing risk of breast cancer even after proposed labeling for this use specifically rejected by FDA
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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
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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
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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
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(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
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FDA made following announcement to postmenopausal women who have taken drug for prevention or treatment of osteoporosis:
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“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.”
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Defendant agreed to plead guilty to charge in information
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Defendant agreed to resolve complaint for permanent injunction by agreeing to consent decree of permanent injunction
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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:
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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:
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http://www.fda.gov/newsevents/newsroom/pressannouncements/2007/ucm108981.htm
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[6] – 9/17/2007Evista Approved for Reducing Breast Cancer Risk:
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http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048474.htm
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[7] – 2007
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Click to access 020815s018lbl.pdf

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[8]
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Click to access ucm088593.pdf

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[9] – 2007
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Click to access 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
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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
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http://www.justice.gov/opa/pr/2013/November/13-ag-1170.html
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