Tag Archives: tell

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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Pete Cohen talks to Steve and Mary Jo Siegel

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This is our the best and the dearest, uh, patient who came to our clinic 20
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2
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2 years ago
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22 years ago
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and she was in the, she came with Hodgkin lymphoma, and a stage 4, and she didn’t have good, uh, prognosis
How long, did they tell you
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They told me that I was gonna die, of non-Hodgkins lymphoma
That I had a fatal disease
They would treat me for awhile with, uh, chemotherapy and radiation, um, a bone marrow transplant, and, um, we, they, we would see what would happen, but no cure
Not a cure at all
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So
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That was 22 years ago
Um, I thank God everyday that I found Dr. Burzynski’s clinic, and Dr. Burzynski and his staff
Um, I was on his treatment for, um, 3 months when this huge tumor on the side of my neck started to reduce and finally disappeared
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So we adopted her as our, uh, family
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(laughs)
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Yeah
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and now, she is our family member, and many others
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So tell me, uh, how did you find out about Dr. Burzynski?
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I was in a cancer support group, and, uh, one of the ladies in there said, you know, you have non-Hodgkins lymphoma
There’s a doctor in Houston whose been treating it with very good results
You should go and check it out
Which I went back home to my husband and said: “There’s Dr. Burzynski in Houston, Texas, and he’s having good results,” and, ah, Steve said: “You know, I’ve heard of this doctor
You know, I wrote his name down”
He’d heard about him
Wrote his name down for future use, and I think about, uh, the next couple of days we were in Houston, and we got to the clinic and I just felt I was in the right place
Everybody there
It was
The feeling was so different than being at a UCLA or a USC or Dana Farber
It was just
I knew immediately I was in the right place, and I met Dr. Burzynski
Well first of all Dr. Barbara came out and hugged me, and, uh, it was, it was so wonderful and I’ll never forget the feeling of, of, uh, my first walk into the Burzynski Clinic
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So tell me, what did, uh, any, did, did you have an oncologist at home and tell them that you were coming here ?
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Yeah, we did
Um, uh, I had an oncologist at UCLA who was a lymphoma specialist, and he was the one that told me I would die of the disease
Um, when we told him that we were going to see Dr. Burzynski, he wasn’t, uh, overjoyed, to say the least, and he told us very negative things and, uh, but I thought, he wasn’t offering me anything, and, uh, when I did get to the Burzynski Clinic, Dr. Burzynski said to me: “I think I can help you,” he said
He didn’t
He didn’t tell me, he was going to cure me
He didn’t
He just said: “I think I can help you,” and, it was non-toxic, and the, um, conventional medicine was offering me high-dose chemotherapy, radiation, and in fact, in mu, as much radiation as people who were, uh, within one mile of ground zero at Hiroshima, and, and they were going to bring me as close to death as possible, and then, rescue me
Uh, and then Dr. Burzynski was going to do this and actually have, where actually I would have hope of a cure, non-toxically
My hair never fell out
I felt well
Um, I lead my normal life
I drove my kids to school
I cleaned the house
Whatever
You know
It was
It’s a wonderful treatment
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So, at what point did you realize, I’m free of cancer ?
Do you remember that point of ?
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Uh, well I remember the point
I remember it very well
Um, the, it
It’s so big
Um, I had, uh, several CAT scans
I had 2 CAT scans in a row
The first one that showed no cancer at all, and, um, I had them done at UCLA, and, um, and then I had a second one, 3 months later, and that one was, was absolutely clear
So, um, it was, it was an amazing feeling, and actually 48 hours was following me, because it was, it was a really a big story, um, you know
Cancer throughout my body
No, no cancer at all and, and my medical records show, um, you look at my X-rays, my CAT scans, from starting Dr. Burzynski’s treatment, um, to approximately 9 months later
Reduction, reduction, reduction, until there was no cancer
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So what did, what did your oncologist say ?
Did you, did you go back to your oncologist and say: “You said I was gonna die”
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Uh, yes, we did that
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And what did he say ?
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And, and actually people would call him and a, people who were interested in Dr. Burzynski, and he would say: “Oh, she’s a spontaneous remission”
He would never accept the fact that I was treated, and cured by Dr. Burzynski, but my medical records prove it, and of, you know I, There are so many patients like me
I’m not the only one
So
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So ok, tell me
Let me ask you a couple more questions
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Mhmm
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What sort of a person do you think Dr. Burzynski is?
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Well aside from being the most wonderful, gentle, sensitive, caring doctor, and you don’t find many of those
I went to many doctors, while, while we were trying to find the answer
Many, and Dr. Burzynski is so above them
He, because he really makes you feel like a person, and that he cares, and, he’s also a genius
He, I know that he speaks about 8 languages
He’s an expert on the Bible
He, he just knows so much about everything
Um, I love to be in the room with him
He’s a very special man
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So, you recovered, and then, ’cause you, when did you set up the patient support group, and why did you do that ?
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Uh, actually my husband and I did that together, and it was during, um, the trials, uh, the Texas State Board started, in fact, I became a patient, and 2 months later, ah, he was brought to a hearing in front of the Texas State Medical Board, and so Steve and I, um, organized the patients to, um, be at that hearing to support Dr. B, ’cause he’d been going through this long before I became a patient, but, um, we wanted to show support, because I was already starting to fe, I was feeling better already
I was already seeing some reduction, and now my, the medicine was in jeopardy
I, It could be taken away from me at any time
So we decided to organize the patients and to show support, and all the patients wanted to help, a, uh, obviously
So, um, we’d go to every hearing, every, uh, the trial, we were there every day, um, and we would, patients would march in front of the court building, um,
It was, it was really a sight
An unbelievable sight
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And why do you think that he was treated the way that he was treated ?
Why do you think they wanted to take him down ?
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I think it’s because
There’s many reasons
I think the main reason is because what Dr. Burzynski does is making what all other conventional doctors are doing wrong, because chemotherapy is not the answer
Chemotherapy makes people sick, and, uh, most of the time it does not cure people
Um, all that poison and radiation
There’s gotta be a better way, and there is a better way
Dr. Burzynski has found it
I was sick
I had cancer 22 years ago
Um, my hair never fell out, and, uh, it was a treatment that I was grateful to be on every day
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So how many patients have you come in contact with that Dr. Burzynski
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Hundreds
Hundreds, and as you say by my patient group web-site
Um, I think I have about 90 stories on there now, and there are many more, because, um, I haven’t been able to get in touch with everybody, but over the years, uh, people give me their stories
Sometimes people will call me, um, but we, we are a patient group because we, we’ve all been helped or cured by Dr. Burzynski, and we, we want everybody to have access to this treatment

Steve actually had the chance to ask one of, uh, one of the prosecutors, um, at the trial, that exact question: “What would you do,” and he was prosecuting Dr. Burzynski, and he actually said: “I’d be first in line”
So, once you know the whole story, and you know the science, and you, especially if you do the research, um, you, you can come to the truth, and the truth is, Dr. Burzynski, has cured cancer
He cured me
I’ve been in remission for, in remission, for, uh, 22 years, and that’s a cure, and, uh, he could help so many, many, many more people
The, he has breast cancer patients now that are, that are doing so well
He has many
I just talked to an ovarian cancer patient
He has, um, all, all different types of cancers
What he needs is funding from our government
Um, all other doctors and, and, um, institutions, they get ah, mu, get so much money from the government
Dr. Burzynski doesn’t get one penny
If we could just think
If, d, if the government would just fund Dr. Burzynski, he could have a cure for all cancers
I believe that with all my heart, and somehow, some day this has to happen
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The Sceptics (10:37)
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Yeah, just tell me what this whole kind of skeptic movement
You do any research on Dr. Burzynski there’s a few things
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Yes
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that always come up
This guy Saul
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Saul Green
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Yeah
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Mmm
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and some other stuff
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Yeah
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So just tell me
What’s that all about and where did that all come from ?
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It stems from, uh, a lawsuit that was filed against, uh, Dr. Burzynski
Actually it was, uh, an insurance company, that didn’t wanna pay for, uh, for the treatment
A particular patient had been treated here in Texas, uh, was put into remission
Was successfully treated and then it turns out the insurance company did not wanna pay for it, so they brought in these people
These quote unquote experts
Cancer experts of, you know, rather dubious backgrounds
This is all that they do, is they look for ways to demean people
They look for ways to blacken their reputation
They ultimately became a group known as Quack watch, and these were brought in as the expert witnesses to say that this is not an approved treatment, albeit, was not true
They said the treatment didn’t work and clearly it did, and, uh, they have since gotten funding from insurance companies, from the government, private funding, and they go around to debunk things that are against mainstream, um, medicine, and, uh, their, their support comes from the insurance company and from the pharmaceutical companies who benefit from, from their work, and, uh, it expanded
Expanded all over the world to, uh, they’re in the United States, they’re in the U.K., they’re in Australia, and, uh, they have a very big presence
When the internet came into being they, you know, they went viral with this kind of stuff
So when you type in Burzynski, uh, a lot of the negative comes up first
So that’s the first thing you see is all this negative stuff, and it’s all hearsay
None of it has any basis in fact
It’s all lies
Um, you know, he, Dr. Burzynski never did anything illegal ever, and it was all based on, on very questionable legal grounds that he was ever sued, that he was, that any case was ever brought against him by the FDA or the Texas Medical Board, and all of those cases failed
They never held up to scrutiny
They all failed, and here Dr. Burzynski is today, and he’s thriving, and people come here from all over the world to be treated
Many are cured of their cancers, and, uh, all of these people in the Quack watch are gone
Uh, Saul Green has passed away
Uh, I don’t wish him ill, but I’m glad he’s not here, thank you, and all of these other people are gone and they’re not thriving, and they’re just like, you know, they’re like bacteria or like fungus under rocks, and when you shine a light on them, they can’t hold up to the scrutiny
The real light is here
The real truth is here in Houston at the Burzynski Clinic
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Thoughts on Dr. Burzynski (13:46)
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What do you think of Dr. Burzynski, yourself ?
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I, I, I think Mary Jo’s pretty much summed it up
Uh, I, am of course
It, it, it’s not an unbiased opinion
It can’t be
He’s the man that saved my wife
Uh, she was cast off, um, as, as, as an incurable
She was told time and time again, not just by her on, oncologist at UCLA, Dr. Peter Rosen, but we went all over the country
We went to USC in, University of Southern California, UCLA, Stanford Medical, Dana-Farber; which is associated with Harvard, uh, in, uh, Boston, and everywhere we went, she was told: “There’s no hope”
“You’re gonna die”
“It’s just a matter of time”
“We have to see how long, how long it’s gonna take”
Um, against my better wishes, we came to the Burzynski Clinic, and she said: “I’m starting today,” and I said: “Don’t you think we should go back and discuss with Dr. Rosen at UCLA ?
She said: “No, they have nothing to offer me”
She was that brave, and we started that day, and we’ve never looked, we’ve never looked back
So to ask me about what I think about Dr. Burzynski, when my wife was told she was gonna die, and I was already making plans for how am I going to take care of my children without Mary Jo; my life partner, and he saved her life, I’m not gonna give you unbiased
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Mhmm
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an unbiased opinion of how I feel about the man
There’s probably nobody, that I have greater love and greater respect for, uh, in, in the whole world, and, uh, to add about how, how smart, how intelligent this man is, ah, expert on, on history as Barbara was saying
Expert on religion
He’s an expert on mushrooms
He knows more about mushrooms than any 10 mushroom experts in the world
Bees
He knows about bees
Who cares about bees, but he knows everything, because bees happen to be a rich production source of antineoplastons
Who knew ?
Dr. Burzynski knew, and that’s why we need to listen to him
We as a society
The world needs to listen to this man
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Conventional Cancer Treatment and The FDA (16:05)
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When you put some critical thought, critical analysis, you find that chemotherapy initially works
What it is, it’s a good, the first time around it’s a good tumor shrinking, they’re good tumor shrinking agents, but over the long run they create so many problems that eventually, the tumor becomes, the cells become resistant and the tumor takes over, or, if it is successful in shrinking the tumor to, to a, a size where the patient can survive, what happens after that is there’s a secondary cancer that’s created by the chemotherapy, with very few exceptions
Testicular cancer is one exception where it works
Some childhood leukemia’s they’ve had some great success with chemotherapy, but by in large it’s a failed modality, and the side effects are so bad as, as to be called horrific, uh, is how I would describe them from what I’ve seen in, in my family and in my friends, and my associates that’ve had to undergo it
So why do we allow that, when something like antineoplastons and Burzynski’s treatment, totally non-toxic, working with the body, allowing you to lead a normal life, and on it statistically for the number of people that have been treated, uh, compared to the number of people that have walked out of here in remission, or cured after 5 years; whatever definition you wanna use, we don’t allow that
We look at that as, uh, conventional medicine looks at like that as, looks at that as some sort of quackery
This is, this is, uh, critical thinking and science turned on its head, and it doesn’t make sense, and it goes back to what I was saying before
Why it doesn’t make sense, because there’s entrenched financial interests, and there’s a paradigm that says we do for cancer, we do chemotherapy, we do radiation, we do surgery, and that’s it
Anything else is not acceptable, because it goes against the paradigm

In the bureaucracy we know as the FDA
We’ve been fighting them for so long and they’ve been described as “The B Team”
“The B Team” is,that they be here when you come in and you start complaining, your problem starts, they be here, and when you decide to quit complaining because you’ve beat your head against the wall for so many years, they still be here (laugh)
So it’s “The B Team”
They’re bureaucrats
This is what they do
There, they have a certain set of tasks
Certain things that they’re tasked with
Protection of the food and drug supply of the United States, whatever that means
Whatever they deem it to mean
Whatever they decide it means
That’s what they’re gonna do, and it’s pretty hard to fight that
It’s pretty hard, unless you have a political, unless you have a, a, a, a political, ah, constituency, and you can put a lot of pressure on them
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So
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and that’s the only way
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So what’s the answer ?
What will, uh
How will Dr. Burzynski prevail ?
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Ultimately, in, in my, in my, in my view, the real tragedy is, is that he’s not going to prevail here in the United States
It’s going to be extremely difficult
It’s an uphill battle that, knowing Dr. Burzynski, he’s gonna keep fighting it, uh, and, and he’ll keep fighting that battle, but the real opportunity for him is to, uh, move this product and license it overseas, and, uh, other countries are interested
Other countries are more open, uh, to new modalities
They’re not entrenched, uh, and don’t have the financial, uh, interests, the, that are, the entrenched financial interests like we do here, like chemotherapy and, and, uh, radiation therapy, and I think that’s where ultimately we as Americans, as sad as it is, are going to have to go overseas to be treated and to get this medication

The FDA is so capricious in their decision-making, and in their exception granting, uh, that if Pat had AIDS, and this was anti-AIDS medication; proven or not or only with limited, uh, proven efficaciousness, uh, and proven limited proof that it was somewhat non-toxic, she would be able to get approval like that
The FDA has taken a drug approval process that generally takes anywhere from 10 to 15 years, and where there is political, successful political pressure applied, they have reduced that down to some cases 4 to 8 months as in the case of the anti-HIV drugs, and that’s because there is a very strong, very powerful political lobby in Washington, and throughout the country, and they have been able to apply pressure at key points in, uh, Congress
Congress puts that pressure on the FDA, says: “C’mon let’s get the ball forward
These are voting people
We have millions of people in this country with HIV who are compacted together and make a viable political force
Let’s move forward”
In the case of multiple-myeloma
In the case of these cancers or these people that wanna be treated, who have failed all conventional therapy, and wanna be treated by Dr. Burzynski with something that we know works
Something that is, is non-toxic, they, they don’t have
We’re not a viable political force
We’re not important to the Washington bureaucrats, to the Washington lawmakers
So nothing gets done, and these exceptions for the use of antineoplastons are not granted, and that’s, that’s the sad truth
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Steve and Mary Jo Siegel
January 2012
22:01
11/9/2012
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Turkey Lurkey Thanksgiving Title

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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 MILLION – Mr. H. Dean Steinke, former Merck employee from federal share of settlement amount (1997 – 2001)
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$23.5 MILLION – Mr. 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
——————————————————————
In addition to criminal plea
agreed to settle civil Food, Drug, and Cosmetic Act liabilities by entering into consent decree of permanent injunction
——————————————————————
Charged in criminal information filed with violation of Food, Drug, and Cosmetic Act, following investigation by Food and Drug Administration’s (FDA) Office of Criminal Investigations
——————————————————————
Plea agreement signed by Lilly and United States

Complaint for permanent injunction

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

a. preventing or reducing risk of breast cancer

b. reducing risk of cardiovascular disease

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

1. systems
2. processes
3. policies
4. procedures
relating to promotion of drug and company’s compliance with consent decree
——————————————————————
FDA made following announcement to postmenopausal women who have taken drug for prevention or treatment of osteoporosis:
——————————————————————
“No postmenopausal woman who has taken Evista for the prevention or treatment of osteoporosis is affected by this action, as this matter today relates only to unapproved uses of Evista.”
——————————————————————
Defendant agreed to plead guilty to charge in information
——————————————————————
Defendant agreed to resolve complaint for permanent injunction by agreeing to consent decree of permanent injunction
——————————————————————
http://www.justice.gov/opa/pr/2005/December/05_civ_685.html
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[2] – 11/13/2013 – The War on Cancer (I don’t think it means, what you think it says it means) #Winning?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/13/httpcancer-orgacsgroupscontentepidemiologysurveilancedocumentsdocumentacspc-036845-pdf/
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[3] – 12/21/2006 – On the messiness of evidence-based medicine
——————————————————————
http://scienceblogs.com/insolence/2006/12/21/the-messiness-of-evidencebased-medicine/
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[4] – 9/13/2007 – FDA 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] – 9/14/2007 – FDA 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] – 9/17/2007 – Evista Approved for Reducing Breast Cancer Risk:
——————————————————————
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048474.htm
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[7] – 2007
——————————————————————

Click to access 020815s018lbl.pdf

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[8]
——————————————————————

Click to access ucm088593.pdf

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[9] – 2007
——————————————————————

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
——————————————————————
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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