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]
======================================
REFERENCES:
======================================
[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
======================================
[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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Pete Cohen chats with Sonali Patil, Ph.D., Research Scientist at The Burzynski Clinic

======================================
1/2012Sonali Patil, Ph.D., Research Scientist at The Burzynski Clinic
(18:22) 9/18/2012
======================================
So you, you, you’re a scientist here ?

I’m a scientist here

And, and you work, just with antineoplastons ?

Not necessarily
This is our cell biology lab, and in molecular biology we do basic research on the antineoplastons
Sometimes we also study it in combination with the other, uh, medicines that Dr. Burzynski is interested in
So, but mostly antineoplaston
This is looking at mechanism for action
Trying to understand how it treats the cancer cells, is able to kill the cancer cells without damaging the other cells of the body
So mostly antineoplaston is the target here

And what do you think about
antineoplastons ?

We have found, uh, very interesting, uh, molecular pathways targets that antineoplaston is targeting, working very effectively to kill the cells, um, probably better than many other drugs, because, um, it has multiple targets, and so attacks the cells from many different angles, and is able to kill the cancer cells, more effectively

So, can I ask you, how did you come to work in, th, the Burzynski
the institution ?

Through an advertisement, it was
My position was advertised
I started 8 years ago, and

So ok
So it was advertised

Mhmm

So when you applied for the job, were you aware of the controversy of, (comments to self: learn to talk)
So when, when did you find out ?

Uh, eh, as soon as I joined (laughing)

Oh yeah ?

Few months later
I thought, it’s easy to find
It’s not hard

Of course

It’s not even, uh

Wha, what about any of you other colleagues, that prior to coming here ?
I mean, did they say anything to you, like, you know ?

Well they brought something up
(?) in, uh, uh, being there for him during this trial, my boss, my previous boss was here before me
Uh, so I have a very open picture of it, and it doesn’t bother me
He came up against it and won

Yeah

So that’s a good thing

An, and why do you think, it kinda hasn’t been, kinda lost the word, hasn’t taken off, you know ?
Has the scientific community hasn’t really embraced ?

Well anything that is non-traditional always, you know, takes its own time to get to people
Besides, the traditionalists don’t want it coming out because, uh, it affects, a lot of other things, um, finance, in, in the big Pharma

Right

that is affected by this
So, um, if it, if it were, um, a medicine already with another big company, it probably would already be out in the market by now, but, uh, it’s because it’s one man’s show
He’s fighting against, uh, traditional medicine, big, big centers like M.D. Anderson right here in Houston
So, most people want to believe, uh, what the other doctors, the oncologists, are telling them, because that’s what everybody does
So very few filter out of that and come looking for him, because they’ve lost hope there, and they’ve tried everything else, and they come because; which I wish they wouldn’t, come here as a last resort, you know

Mmm

and, by then, sometimes, uh, enough damage has been done that is sometimes even he cannot cure
It’s not magic
It’s
There’s a logic to the way the medicine works
The science behind it is not, it’s not just a magic bullet
So, and you have to target it at the right time
Catch cancer at the right time

So I have a, friend of my mother’s at home, whose spent, her whole, academic career, 20, 30 years, researching, astrocytomas

Mhmm

And, uh, you know, I did my research, and, I was no doubt that we were coming here
No question
My, my research was more based on people

Excuse me

On people
Talking to people who had been treated, and seeing the results, and then looking at the research afterwards, and she was just saying that “I’ve spent all my years, research, and research, and research, I can’t find anything, that validates, this, this treatment
Now I’m not asking you to comment on what she said, but,

No, validation, validation basically means, uh, proof in scientific community
If you’re not accepted into the scientific community, you’re not going to be able to present that truth, and we go and present at conferences all the time, eh, when it comes to publishing papers, uh, we haven’t been very successful
Dr. Burzynski has published, uh, a lot of data of his patients
So it’s out there

Yeah

If you, if you want to believe it, and you’re looking for it, you’ll find it

Yeah

It’s just, um, it’s not in the mainstream places, because it gets rejected out of there
Um, it’ll probably take some time to get into those spots where everybody else is publishing, and everybody else is talking about it, but it doesn’t mean that it’s not true

So obviously you’re here on a daily basis
So when was the 1st

Last 8years

So the last 8 years
When was the 1st time you actually saw, was it in the dish where you actually saw it ?

Well we see it, we’ve seen it for years before I came here

Yeah, but when was the 1st time you saw it, when you came here yourself and you saw ?

Well we see it every day
Um, we have cancer cells in the lab, that we treat, with the medicine
We see them dying
We see them undergoing a necrosis, which is the cancer deaths, pathway, that most people study and talk about

So

So, it’s happening, it’s happening in front of our eyes everyday
So, we have proof for it
you know (?)
We just have to get it out there, and there’s a, there’s a system to all that

Um

and were trying to, get it through the system, and get it out there

So what, when you 1st realized there is something here, did you not just feel like just shouting from the rooftops and telling everybody?

Well I wasn’t the one who discovered
He did, in the ’80’s

Yeah

and since then he’s been shouting from the rooftop
It’s just, nobody would listen to him

Yeah, yeah

So, you know, we’re just doing the, uh, actually it’s backwards
People usually do, uh, pre-clinical research 1st, because the medicine

Mhmm

goes out and to the patients, and we, we are kind of doing it, the other way around
He already has patient data
He’s been treating people
on this
People, survivors walking around, to tell the story, and now we are being made to understand how it works in the cells
So, it’s, it’s kinda doing, the research, after the trials

Just tell me
One more question
What’s it like
How would you describe Dr. Burzynski ?

I admire his, uh, passion, for what he does
He truly believes in what he does, and to me that’s, that’s a big thing
If you don’t believe in yourself, then nobody else will, and, his memory
He, he has tremendous memory, and, uh, uh, quick thinking
He’s able to piece together stuff, uh, research articles, papers, put together puzzle, come up with a theory
He does that every day, every time I meet him it’s, it’s interesting to me to see how his brain works

you say, in, in the purest sense, he’s a scientist

I think he’s a doctor 1st, but a doctor who’s very, very interested in science, and that’s an important thing, because a lot of, uh, doctors don’t care about the research, and he does
I think, I think his primary aim is to treat patients, mostly

So if there were any type of skeptic, research scientist out there, what would you say to them about what goes on here?

We do, we do, everything that happens in any other lab, anywhere else
I went to school at Houston, ah, so, I know exactly how the labs work
We do exactly what they do

Yeah

Um, we try to write up our papers, and send them to the journals, just like everybody else does
Uh, present at conferences
We try to get our data out there
Um, we’re trying to do our best, just the way everyone else is

I, I suppise trying to do your best it, it, it’s fascinating because you actually have something

Yeah

that really, really does work

Mhmm

I mean, it’s a cure, right ?

We believe it is

It’s a cure for cancer
Not for all cancers
I actually asked Dr. Burzynski

Mhmm

I filmed him the other day and said to him, why do you, specialize in brain tumors ?

Mhmm

Do you know what his answer was ?

What was it ?

He said it’s because it’s the most difficult type of cancer

Well it is if, if you think about it
I don’t think there are many doctors who claim to have survivors, eh, at least in the numbers that he has, to present

Yeah

and, um, I hear that at conferences too when we, were standing around, they will look at the slides, eh, eh, which is a tumor, and they will say: “Well that’s not a tumor,” ye, “it’s just necrosis
It’s just a patch on the skin, and you just cured nothing, and”, uh, all the, “the patient was probably cured from, the therapy that he took elsewhere, you know, the radiation he got 10 years ago”
“That’s probably what cured him,” but, you know, th, those kind of patients will be rejected from other, hospitals, don’t survive, that far enough to, to tell a story

So what is it ?
Just people living in denial ?
Is it fear ?
Is it ?

Fear or denial
I’m going to do what everybody else does
Why, why should I go out and do something different, here ?
Yeah (?)

And, and lastly, you know the, the power the pharmaceutical companies have

Well of course
I mean, but I’m nobody to, comment about that

Yeah, yeah

You know
There’s, there’s a lot going on behind the scenes that we are not even aware of, but this is just what, um, my experience is, when I talk to other doctors at meetings and conferences, and they, you’re immediately dismissed as, oh, you know: “What you’re going to say doesn’t really make any sense because you work for, Dr.

His name has been tarnished
——————————————————————
There’s a lot more, to that, than just, people playing politics, this, this, a whole lot of stuff going on behind there
So, I don’t think it’s, it’s (supression ?) as much, it’s just trying to tell your story, uh, so that somebody would listen and accept it, uh, maybe using, the right channels, going, presenting it in a different way, make it more convincing
All that, would help

So if it, if it was you, in his position, would you not have just given up ?
Or would you

Oh, definitely
We all talk about it all the time, that the amount of determination that he has, most people, would back off and leave, but like I said, he believes in what he does, and that’s what keeps him going

Yeah
As far as publishing is concerned, ’cause a lot of scientist want to see

We’ve tried
We, we, don’t get past the initial screening
We repeatedly send it back to other journals and that’s the process I keep doing all the time
Comes back, I send it back to another journal
Hopefully, one day it will get it

So, let, let, let, let me get this straight, ok ?
You write articles, right ?

Papers

Papers

Mhmm

and you submit them to, medical journals

Mhmm

and then what happens ?

They come back

Why do they come back ?

Sometimes, um, if they get to reviewers, uh, it’s not enough data, or, which I understand
We can work on changing, modifying papers, but, many times they come back, without any reason
They just get rejected, at the 1st, screen itself
So they come back without any reason

And why do you feel that is, in your own humble opinion ?

Wha ? (laughing) not humble opinion
It’s, it’s hard, um, publishing is a tricky game, you know ?
You have to publish once, to get your name in there, and then, they might publish you again, but, uh, with the negative publicity that we already had, and most of the community would look at the name and say: “Oh we, we just don’t want to, want to even read it”
So, it, it doesn’t even get past the 1st screen, because they don’t turn, flip the 1st page even

Ok, so, what you’re saying is that you see things that are published in these journals

Oh yes

And, you see ?

very similar stuff
We try to, we try to do research that is on par, uh, with what everybody else is doing, as far as the techniques, the ana, the data analysis
We, we try to do everything which is the standard for, uh, the research community, but, doesn’t get past

Um, how frustrating must that be for you ?

Mmm, it is (laughing), it is

So do you feel like you’re a party, or you’re trying to get into a party, and knocking on the door, and no one’s letting you in ?

I feel like that at the conferences too because, um, sometimes they come up to your, poster presentations, and, um, they’ll ridicule you right there, while you’re standing there by your presentation

Ok, just last thing, because one of the things I heard

Mhmm

recently, which were, that, uh, there’s some evidence that Dr. Burzynski has from, from the phase 2 clinical trials, showing people who have, uh, glioblastomas who’ve been alive for 10 years

Mhmm

and there’s something there that they want to try and get published

Mhmm

What you’re saying is, that might never get published ?

Well, Dr. Burzynski’s case is different
He has published some of his patient data
I’m talking about the research, uh, the pre-clinical research, the cell culture data, the molecular data
Um, we haven’t had success getting that out, but, he has, he also faces rejection a lot, but he doe, he has managed to get ta, a few publications in

So how does it work ?
If, if you submit something they can
What’s the process ?
They can submit it back ?

That’s not, there’s a review
There’s a whole review board
Um, you can select your reviewers
It goes through couple of cycles of review before it’s, agreed that they will publish it
So,

And in case they say no to publishing it

You can

do you, can you take it somewhere else ?

Yeah, you can take it somewhere else, but, um, but it’s, the peer-reviewed journals that are the ones that you want to get into, you can publish whatever you want, ah, that doesn’t count
That’s why when, somebody who’s of, uh, any significance in science would not even look at those articles if they’re not in a peer-review journal
So, they have to get into a decent place to make a mark

Do you think that will happen ?
What do you think has to happen in order for ?

It’ll happen, in, in time
They can’t keep refusing you
We, we try again and again
——————————————————————
But in time they just want to, not focus on it, and just have’m, bring in more numbers, and keep doing this, and in the meantime keep treating, some number of patients
On, on, top of everything, my personal belief is, uh, brain tumors are not, uh, a money-raising factor, because it’s a, it’s a minority cancer
If this were treating, uh, mainstream cancers as they’re called, as, uh, breast cancer, maybe they would look at it more seriously, but the numbers, with the brain tumors, which is a good thing
I mean it’s a deadly cancer
You don’t want more people to have it, but, that puts it in the category of, um, you know, not so feasible, as far as the money-making
And so, the priority; even though, it’s the most vicious, and it should be looked at more seriously, but, it’s not the one that brings the big bucks

So

So, put it aside

So why would the FDA, haven’t closed him down then ?

Because they, they, uh, believe the data that he’s sending them so far, and they don’t have a valid point to, just say no, it doesn’t work, and put it away
They see effect, and so they want, more numbers, more data

Is it, it the phase 2 trial is finished ?

Mhmm

but they’re still accepting people ?

Yeah

on more like a special ?

Special basis, and, um, sometimes compassionate grounds

(compassion exception)

Uh, exceptions

That’s normal ?

Yes
So

(Yes I guess it is a funding issue ?)

Right

(Like FDA, during the 2nd phase of clinical trials they found the data to be, real, real one, and they gave him the ok to go for 3rd phase of clinical trials, but just to go through this process you would probably need $100,000)

(?) and that’s stalling

(even more, millions dol, millions of dollars, to go through the 3rd phase of clinical trials, and)

(?)

(he’s a single doctor
It’s a 1st case)

Yeah

(probably in American history)

It is

(that single doctor is trying, to get a his job)

Self-funded

(approval
Self-funded
Whatever you’ve seen on that plant, everything came out of his practice
So he was the one who funded, literally the, the, research and development phase, but those installation, operation, all this big plant was built ?)

Yes, ’cause, uh,

(private)

one of the things I hear a lot, I’ve heard slot in the U.K. is that: “Why is he charging people for clinical trials ?

Well, uh, how else would you run this place ?

Exactly
How will you run this place, and how else will people be on the trial, because

Right

you know, there’s no pharmaceutical company involved here, right ?

There’s nothing
Nothing
It’s all out of his pocket
Every single bit
So
And what is stalling (?) is (?) again is, is funds
Money

Yeah, I also heard that the phase 3 they wanna do radiotherapy with, with it

Mmm

Hopefully, that will not be the case, but

we’re trying to
I think, uh, he is trying to fight against that, but, the FDA is the FDA, so

And what do you think about this case, he’s now got coming up in April ?
You know, he’s got this court case

Well there’s always something

Yeah (laughing)

He, he’s won before, so

Yeah

Do you think he needs the support, do you think he feels the support from, from all of you ?

I think so, for sure

(Oh, absolutely)

Yeah

Nobody forced us to work here

(Ah-hah)

Yeah

We get paid, but, you know
I could always look for another job if I needed to (laugh)

Yeah
So would you stay here because you really believe in what’s going on here ?

(?)

(Yes, that’s one thing that’s unique about our operation, and I’m talking about this location is, uh, whoever joined the company; and we have a guys who joined the company in the 80’s, 90’s
They stay with the company
Turnover is zero)

Yeah

(Joined the company
Stays with the company
It’s a challenge)

Yeah

(It’s a (?) challenge for us)
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Dr. Michael A. Friedman, DATA ?

[1] – 11/2/1993 – Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Services, National Institutes of Health (NIH), sent a 3 page letter to Burzynski, which advised, in part, on page 1:

7. “In accordance with your letter we will arrange a review of data after accrual of the 1st 5-6 patients, which should occur 6 months after the study has been initiated”

“The Theradex database is also available … “
——————————————————————
[1] – 11/2/1993 – This makes it clear that: “review of data” is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

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[2] – 1995 (4/3/1995) – Dr. Mario Sznol, Department of Health & Human Services (HHS), Public Health Services, National Institutes of Health (NIH), National Cancer Institutes (NIH), sent a 2 page letter for Dr. Michael A. Friedman, to Burzynski, in response to his letter of 3/29/1995, which advised, in part, on page 1:

“We will forward the data on the 1st 5 patients in a separate mailing as you requested”
——————————————————————
[2] – 4/3/1995 – This makes it clear that: “We will forward the data … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

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[3] – 1995 (4/20/1995) – Burzynski sent a letter to Dr. Mario Sznol, Department of Health & Human Services (HHS), National Institutes of Health (NIH), in response to his letter of 4/3/1995, which advised, in part, on page 2:

“We are anxiously awaiting the complete data on the 1st 5 patients as promised in your letter of 4/3/1995″
——————————————————————
[3] – 4/20/1995 – This makes it clear that: “We are anxiously awaiting the complete data … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-162456.jpg
[4] – 1995 (5/16/1995) – Burzynski sent a letter to Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), National Institutes of Health (NIH), in response to his letter of 5/12/1995, which advised, in part, on page 2:

“I still have not received the complete data on the 1st 5 patients, which was promised in your letter of 4/3/1995″
——————————————————————
[4] – 5/16/1995 – This makes it clear that: “I still have not received the complete data … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-164323.jpg
[5] – 1995 (6/6/1995) – 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), sent a 3 page letter to Burzynski, in response to his letters of 4/20/1995 and 5/16/1995, which advised, in part, on page 1:

“Also contrary to your statement, you have been sent monthly clinical summaries of these patients since 7/1994 directly from Theradex

(see 3/9/1994 letter)
——————————————————————
[5] – 6/6/1995 – This makes it clear that: ” … you have been sent monthly clinical summaries … directly from Theradex IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

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[6] – 8/23/1995 – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Council, Public Health Division, sent a 1 page letter to Burzynski’s attorney, Richard A. Jaffe, Esq., which he copied Dr. Michael A. Friedman on, which was in response to his letter of 7/21/1995, which advised, in part:

” … you requested in your letter that we provide you or Dr. Burzynski with the medical records of patients treated by the Principle Investigators”

“To our knowledge, Dr. Burzynski has received, on an ongoing basis, complete copies of the reports prepared by Theradex after the Principle Investigators submit their data”

“Dr. Burzynski has received precisely the same information that is provided to the National Cancer Institute (NCI)”

“The NCI does not possess any individual patient records to provide to Dr. Burzynski”
——————————————————————
[6] – 8/23/1995 – This makes it clear that: ” … Dr. Burzynski has received … complete copies of the reports prepared by Theradex after the Principle Investigators submit their data” IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

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[7] – 1995 (9/19/1995) – 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), sent a 2 page letter to Burzynski, which advised, in part:

“I am replying to your 8/29/1995, letter in which you requested “detailed records” of the patients treated in the National Cancer Institute sponsored trials of antineoplastons”

“Our records indicate that the data has been regularly supplied to you by our contractor, Theradex, as listed below:”

7/18/1994 Clinical Studies Summary
8/24/1994 Clinical Studies Summary
9/19/1994 Clinical Studies Summary
10/24/1994 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report
11/14/1994 Clinical Studies Summary
12/19/1994 Clinical Studies Summary
1/13/1995 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report
2/21/1995 Clinical Studies Summary
3/15/1995 Clinical Studies Summary
4/10/1995 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report

Pg. 2

“We have no individual patient records in our possession in addition to the Theradex reports”
——————————————————————
[7] – 9/9/1995 – This makes it clear that: ” … data has been regularly supplied to you by our contractor, Theradex … :” IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

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[8] – 10/5/1995 – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Counsel, Public Health Division, sent a 1 page letter to Burzynski’s attorney, Richard A. Jaffe, Esq., which advised, in part:

“This is in response to your 9/8/1995 letter in which you reiterate your request for copies of individual patient records and argue that the protocol for the study of Antineoplastons specifically provides that medical records of patients treated by the Principal Investigators will be provided to Dr. Burzynski”

“It is our understanding that NCI offered to allow Dr. Burzynski to participate in an interim and final meeting in which patient data from the study was to be reviewed”

“However, these meetings never took place because of the insufficient patient accrual and decision not to complete the study”

“With regard to the portion of the medical record which you forwarded, the stamp does indicate that the patient was seen at the National Institutes of Health’s Clinical Center”

“We have learned that 2 patients were enrolled in the Sloan-Kettering study through the Clinical Center and hence, even though the Clinical Center did not have its own protocol, it has medical records for those 2 individuals”
——————————————————————
[8] – 10/5/1995 – This makes it clear that: “… these meetings never took place because of the insufficient patient accrual and decision not to complete the study”, is NOT Theradex, but the prior letters do NOT mention the word “MEETINGS”
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[1] – 11/2/1993 – This makes it clear that: “REVIEW OF DATA” is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[2] – 4/3/1995 – This makes it clear that: “WE WILL FORWARD THE DATA … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[3] – 4/20/1995 – This makes it clear that: “We are anxiously awaiting the complete DATA … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[4] – 5/16/1995 – This makes it clear that: “I STILL HAVE NOT RECEIVED THE complete DATA … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[5] – 6/6/1995 – This makes it clear that: ” … you have been sent monthly clinical summaries … directly from Theradex IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[6] – 8/23/1995 – This makes it clear that: ” … Dr. Burzynski has received … complete copies of the reports prepared by Theradex after the Principle Investigators submit their data” IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[7] – 9/9/1995 – This makes it clear that: ” … data has been regularly supplied to you by our contractor, Theradex … :” IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-154926.jpg
Why would you advise Burzynski:

[2] – 4/3/1995 – “WE WILL FORWARD THE DATA” if you had FORWARDED “THE DATA” since

[5] + [8] – the 7/18/1994 Theradex Clinical Studies Summary ?

Dr. Michael A. Friedman, DATA ?

Where is the DATA ?
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