Pete Cohen talks to Steve and Mary Jo Siegel

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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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
——————————————————————
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
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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] – 9/13/2007FDA 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
——————————————————————

Click to access 020815s018lbl.pdf

======================================
[8]
——————————————————————

Click to access ucm088593.pdf

======================================
[9] – 2007
——————————————————————

Click to access 022042lbl.pdf

======================================
[10] – 10/18/2013 – Deconstructing Dr. David H. (Orac) Gorski – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
——————————————————————
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
======================================

United States Food and Drug Administration (FDA): September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51

20131021-200529.jpg

20131021-200553.jpg
[1] – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
======================================
BB – Bob Blaskiewicz
——————————————————————
DJT – Didymus Judas Thomas
======================================
0:47:00
——————————————————————
BB“Ummm, o-kay”

“Uh, I want to turn this over to the people who are watching”

“Um, I want to give them a a chance to address you as well”

“Uhmmm, hi everyone”
——————————————————————
0:48:00
——————————————————————
0:53:00
——————————————————————
BB“A every time that I and and and and, and David (James @StortSkeptic the Skeptic Canary) points this out, that um, you you know you’re not going to speculate about the the FDA but then at every turn you’re invoking the FDA as being obstructionist
——————————————————————
0:54:02
——————————————————————
BB“I, I just find that to be contradictory and and self-defeating
======================================
DJT – Bob, exactly where did I invoke “the FDA as being obstructionist” ?
======================================
1:02:00
——————————————————————
BB“Um, it’s it’s it’s not the FDA’s, but you understand it’s not the FDA’s job to tell someone that their drug doesn’t work
——————————————————————
1:03:00
——————————————————————
BB“it’s it’s it’s up to Burzynski

“It’s up to Burzynski to show that his drug does work”

“And it’s always been his burden of proof

“He’s the one that’s been claiming this miracle cancer cure, forever”
======================================
DJT – Bob, Burzynski showed and proved what he needed to prove to the FDA in order to do phase 2 clinical trials, 9/3/2004 – FDA granted “orphan drug designation” (“ODD”) for Antineoplastons (A10 & AS2-1 Antineoplaston) for treatment of patients with brain stem glioma, .10/30/2008 – FDA granted “orphan drug designation” (“ODD”) for Antineoplastons (A10 and AS2-1 Antineoplaston) for treatment of gliomas, and FDA approved phase 3 [1-2]

Oh, and Bob, exactly when did Burzynski 1st claim “this miracle cancer cure” ?
======================================
1:04:02
——————————————————————
BB“Um, that we’d love to see, however we can’t see, however we can’t see it because of proti protri proprietary uh protections that the FDA is giving to Burzynski, right ?”

They’re not sharing his trial designs because they are his trial designs, right ?”

“That the makeup of his drug that he’s distributing are his, uh design, and his intellectual property

“So the FDA is protecting him, uh from outside scrutiny
======================================
DJT – Bob, you make it sound like it’s part of some grand “conspiracy” between Burzynski and the FDA to keep information from “The Skeptics™” [3]
——————————————————————
21CFR601

Subpart F–Confidentiality of Information

Sec. 601.50

Confidentiality of data and information in an investigational new drug notice for a biological product

(a) The existence of an IND notice for a biological product will not be disclosed by the Food and Drug Administration unless it has previously been publicly disclosed or acknowledged
======================================
BB“While you may imagine that that, that that the FDA is is somehow antagonistic toward him

“They’ve given him every opportunity, over 60 opportunities to prove himself worth uh their confidence and hasn’t
======================================
DJT – Bob, that certainly explains the 9/3/2004 and .10/30/2008 ODD’s and phase 3 clinical trial approvals by the FDA – NOT [1-2]
======================================
1:05:00
——————————————————————
1:42:00
——————————————————————
BB“I don’t, the thing is though that, that that’s a inver, shifting the burden of proof off of Burzynski”

“Burzynski has to prove them wrong, has to prove him right”

“The FDA is not there to say this doesn’t work”
======================================
DJT – Bob, who initiated and put into place the clinical trial hold ?

Burzynski ?

FDA ?

Both ?
======================================
1:43:30
——————————————————————
BB“So, I mean, honestly, um, saying “Well, when the F, FDA tells you that it doesn’t work, the FDA’s never gonna say that because that’s not their job
——————————————————————
1:44:00
——————————————————————
BB“That’s not an option, because they’re never gonna do it

“They relinquish, a lot of authority, over to Burzynski, and his Institutional Review Board, which, I would mention, has failed 3 reviews in a row”
======================================
Bob, where are the “final reports” for those “3 reviews” ?
======================================
BB“Right ?”

“It is Burzynski’s job to be convincing”

“It is not our uh, uh, it it it he hasn’t produced in decades

“In decades”

“In hundreds and hundreds of patients, who’ve payed to be on this”

“Hell, we’d we’d we’d like a prelim, well when you’re talking about something that is so difficult as brainstem glioma, that type of thing gets, really does in the publishing stream get fast-tracked there”
======================================
DJT – Bob, Burzynski has provided numerous phase 2 clinical trial preliminary reports, which our #fave oncologist has chosen to ignore [4]
======================================
BB“they test it”

“Yeah, and they they they want uh, that was evidence of fast-tracking is what, that rejection was uh e was very quickly
======================================
DJT – Bob, have you checked The Lancet Oncology [5] to see what was so much more important than Burzynski’s “phase 2 clinical trial Progression-Free Survival (PFS) and Overall Survival (OS) re patients 8 – 16 years after diagnosis, results” [6] and the Japanese antineoplaston study ? [7]
======================================
BB“So, how long will it be before Burzynski doesn’t publish, that you decide that uh perhaps he’s he‘s, doesn’t have the goods ?

“Um, so, uh, uh again, the FDA is not the arbiter of this

“It’s ultimately Burzynski”

“You’ve been speculating about what the FDA’s motivation are like crazy”

“Why not speculate about Burzynski a little bit”
======================================
DJT – Well, how have I been speculating ?
======================================
1:46:00
——————————————————————
BB“Well actually I’m not even asking you to speculate about Burzynski, I’m only asking you to tell me, how long would it take, uh how, for him to go unpublished like this, um, for this long, before you would doubt it ?”
======================================
DJT – Note how, above, without proving it, Bob claimed “at every turn you’re invoking the FDA as being obstructionist”, and now, directly above, again, without proving it, Bob claims “You’ve been speculating about what the FDA’s motivation are like crazy”
——————————————————————
DJT – what the journals keep saying, in response
======================================
BB“What ?”
======================================
DJT – You know, are they going to give The Lancet response, like they did in 2 hours and such, saying, “Well, we think your message would be best heard elsewhere,” or they gonna gonna give The Lancet response of, “Well, we don’t have room in our publication this time, well, because we’re full up, so, try and pick another place” ?
======================================
BB“But these but but but that doesn’t have any bearing on

“That doesn’t”

“Oh I’m not asking you how long, how long, would it take you for you to start doubting whether or not he has the goods ?

“How long would it take ?”

“It’s a it’s a it’s a question that should be answered by a number uh uh months ?

“Years ?”

“How long ?”

“It’s been 15 years already”
======================================
DJT – Well, you like to jump up and down with the “15 year” quote, but then again I always get back to, Hey, it’s when, when the report, when the clinical trial is done
——————————————————————
1:47:06
——————————————————————
DJT – Not that he’s been practicing medicine medicine for 36 years, or whatever, it’s when the clin, clinical trial was done
======================================
BB – “I could push it back to 36 years”

“He hasn’t shown that it works for 36 years”

“I can do that”

“I was being nice”
======================================
DJT – Note how Bob acts like he’s been hit with “The Stupid Stick”

If he wants to go back “36 years”, I can refer back to 1991 (11/15/1991) – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services (HHS), Public Health Service, National Institutes of Health (NIH), National Cancer Institute (NCI), sent a 1 page Memorandum Re:
Antineoplaston
to Decision Network, which advised, in part:

It was the opinion of the site visit team that antitumor activity was documented in this best case series and that the conduct of Phase II trials was indicated to determine the response rate” [8]
——————————————————————
DJT – The FDA A believes there is evidence of efficacy
======================================
BB – “Perhaps based on bad phase 2”
======================================
DJT – Well, we don’t know that

We don’t have the Freedom of Information Act information
——————————————————————
DJT – Remember, Bob is the one who told me during the 9/28/2013 Google+ Burzynski Discussion Hangout:

“You’re you’re you’re assuming”

“You’re you’re you’re assuming that”

“You’re assuming that”

“Um, I’m not assuming that”

“There is a correct answer here”

“You don’t know”

“You don’t know”

“You need to look into it”

“Alright ?”

“Before you dismiss it you have to look into it”

“Everytime somebody throws uh uh something to me,
I have to look into it”

“That’s just, it’s my responsibility as a reader”

“T t and what I would honestly expect and hope, is that you would be honest about this, to yourself, and and and that’s the thing we don’t, we often don’t realize that we’re not being honest with ourself

“I try to fight against it, constantly”

Bob just ASSUMED that the FDA approved phase 3 clinical trials for Burzynski “Perhaps based on bad phase 2”, but tells me NOT to ASSUME ?
======================================
BB“He withdrew”

“He withdrew the the phase 3 clinical trial”

“I that before recruiting,
although I’ve seen lots of people say they were on a phase 3 clinical trial

“I wonder how that happened”
======================================
DJT – Well, we know what happened in the movie because Eric particularly covered that when they tried to get what, what, was it 200 or 300 something institutions to take on a phase 3, and they refused
======================================
1:48:01
——————————————————————
BB“Uh did do do you think that if they thought that he was a real doctor that they all would have refused like that ?
======================================
DJT – Well, Eric gave the reasons that they said they would not take a particular uh phase 3

And so using that excuse that you you just gave there, I’m not even gonna buy that one, because that’s not one of the reasons
——————————————————————
Note how Bob pulls out the old “if they thought that he was a real doctor” line ?

Is Bob now claiming that Burzynski is NOT even a “real doctor” ?
======================================
BB – “He’s changed things”
======================================
DJT – Eric said they gave
======================================
BB“That The Lancet is a top-tier journal like New England Journal of Medicine

“It’s basically be, besieged by uh 100′s of people submitting their, their, their reports”

“Um, it’s just, you know, let’s say he, someone has such a thin publishing record as Burzynski does, do you think that it’s likely that he will ever get in a top-tier journal ?

“What about the the Public Library of Science?”

“It’s not the only journal there”

“What about BMC Cancer ?”

“There’s lots of places that he can go”
======================================
DJT – We’ll I’m
======================================
BB“Um, and he doesn’t seem to to have evailed himself of that, as far as I can tell

“And I would know because he’d get rejected, or he’d be crowing, you know”
——————————————————————
1:49:02
——————————————————————
BB – “Either way, he’s gonna tell us what happens”

He told us what happened with The Lancet, you know”

“I don’t have any evidence that suggests to me that he’s even trying”
======================================
Note how Bob refers to Burzynski’s numerous publications as “such a thin publishing record”

Bob, do I need to count all of these for you ? [9]
——————————————————————
DJT – Well, I’m, I’m sure that they’re going to keep you appraised just like they have in the past, just like Eric has done in the past

So

I mean, we’ll see what happens with the Japanese study [7]
======================================
BB – “So let’s go back to this”

“How long will it take ?”

“How long will it take before you, the Japanese study’s interesting too because we should be able to find that in the Japanese science databases, and we can find, we can’t find it at all

“We can’t find it anywhere”

“And, and those are in English, so it’s not a language problem

“We can’t find that anywhere”

“We’ve asked”

“We asked Rick Schiff, for, for that study”

“And, and it hasn’t come to us

“He is now I believe on the Board of Directors, over there”
——————————————————————
1:50:00
——————————————————————
BB – “He should have access to this”

“We can’t get it”
======================================
Bob, did you ask:

1. Annals of Oncology 2010;21:viii221 ?

2. European Society for Medical Oncology (ESMO), Colorectal cancer, Abstract: 3558, May 17, 2010 ?

3. Colorectal Cancer Association of Canada, COLORECTAL CANCER RESEARCH, Month Ending June 19, 2009
11. Antineoplaston Therapy Doubles 5-Year Survival Rate Following Curative Resection of Hepatic Mets (May 27/09) pg. 5 of 20 ?

4. Kurume University School of Medicine (Japan) Department of Surgery ?

5. Hideaki Tsuda ? [7]
======================================
BB – “How how long will it take before you recognize that, nothing is forthcoming ?”

“How long would that take ?”
======================================
DJT – Well that’s like me asking “How long is it going to take for y’all’s, y’all‘s Skeptics to respond to my questions ?”

Because y’all haven’t been forthcoming
======================================
BB“Well, I mean, were talking about a blog here

“We’re talking about life”

“No, we’re talking about a blogger’s feelings in that case

“In in this case we’re talking about, 1,000′s of patients, over the course of of of generations, you know”

“This is important stuff”

“This is not eh eh equating what’s happening to to patients with what’s happening to you is is completely off-kilter as far as I can tell

“It’s nothing”

“It’s nothing like you not getting to say something on my web-site”

“You know”

“This is they they have thrown in with Burzynski, and they’ve trusted him, and he’s produced nothing

“Nothing of substance”
——————————————————————
1:51:00
——————————————————————
BB – “Nothing that that has made all of that um, uh, n nothing th th th that uh his peers would take seriously”

“The other thing that that that strikes me now is that, you know, you you you you keep saying that, well Eric is going to to share things with you”

“Does it ever concern you eh uh eh occur to you that Eric might not be reliable ?”
======================================
Bob, do you want to have a contest to determine which of you is more “reliable” ?
======================================
DJT – Well, he gave you The Lancet information and he posted the e-mail in the movie, and Josephine Jones posted a copy of it [6]
======================================
BB“He then, and then he”

“And then he he, you know, the the the the dialogue that sprung up around that was, well see, he’s never going to get to get published”

“Well you’re just setting yourself up for wish fulfillment”

“You want him to be, persecuted, so you are ecstatic when he doesn’t get to publish, which is unfortunate for all the cancer patients, who really thought that one day, all the studies were going to be published”
——————————————————————
1:52:00
======================================
DJT – Well, y’all are free to, you know, claim that all you want, because I don’t always agree with Eric, and uh, he’s free to express his opinion
======================================
BB – “Where has Eric been wrong ?”
======================================
DJT – Well I don’t necessarily believe, what Eric would say about, you know, The Lancet that refused to publish the 2nd one, for the reasons he stated, and which y’all have commented on, including Gorski

You know, I don’t necessarily agree with that

I am more agreeable to y’all, saying that, you know, they’re busy, they’ve got other things to do, but I’m kind of still laughing at their 1st response which he showed in the movie about how they felt about, you know his results would be better in some other publication

I thought that was kind of a ridiculous response to give someone
======================================
BB“It’s it’s it’s it’s a form letter

“You know”

“They’re just saying, “No thanks””

““Thanks, but no thanks” is what they were saying, in the most generic way possible”

“Like I said, they’re besieged by researchers trying to publish
——————————————————————
1:53:05
======================================
DJT – Well you would think that if its a form letter they would use the same form that they used the 2nd time

You know, they didn’t use the same wording that they used the 1st time

I would have think that, you know, their 2nd comment
======================================
BB“So, so, possibly”

“So possibly what you are saying is that they in fact have read it, and after having read it they’ve rejected it”

“Is that what you’re saying ?”

“Because that’s what peer-review is”
======================================
DJT – Nah, I’m not saying that they did that all

I’m just sayin’, you know, that they gave, 2 different responses, and I would think that the 2nd one they gave
======================================
BB – “Do you know it was the same editor, that it came from the same desk ?”

“You can’t make that assumption that that the form letter will be the same form letter every time”

“I mean you just can’t

“I mean in in some ways we have a lot of non-information that you’re filling in, with what you expect, as as opposed to what’s actually really there, and I I I just think you’re putting too much uh stock in one uh, uh, in in in in this uh the publication kerfuffle
——————————————————————
1:54:16
——————————————————————
BB“Um”
======================================
DJT – Well I find it funny, something along the lines of, you know, “We believe your message would be received better elsewhere, you know

I don’t see that as a normal response, a scientific publication would send to someone trying to publish something

I mean, to me that sounds, like, if you’re doing that, and you’re The Lancet Oncology, maybe you need to set some different procedures in place, ‘cuz you would think that with such a great scientific peer-reviewed magazine, that they would have structured things in as far as how they do their operations
======================================
BB“Well, not necessarily

“I’ve been in any # of professional groups where the organization is just not optimal, and publications certainly th there are all sorts of pressures from all sorts of different places”
——————————————————————
1:55:08
——————————————————————
BB“I I have no problems whatsoever with seeing that this might not be completely uh um uh streamlining uniform processes as possible

“The fact that it’s not uniform, doesn’t have anything to do with Burzynski not publishing, not producing good data”

“Not just going to a, you know, god, even if, even if, let’s put it this way, even if he went to a pay to play type publication where you have to pay in order to get your manuscript accepted; and he has the money to do this, it wouldn’t take that much, and he were to put out a good protocol, and he were to show us his data, and he would make his, his his stuff accessible to us, then we could validate it, then we could look at it and say, “Yeah, this is good,” or “No, this is the problem, you have to go back and you have to fix this””

“Right ?”

“So we really, every time we talk about the letter that he got, yeah that doesn’t have much to do with anything, really”
——————————————————————
1:56:02
——————————————————————
BB – “We wanna see the frickin’ data”

“And if he had a cure for some cancers that otherwise don’t have reliable treatments, he has an obligation to get that out there anyway he can

“And if if peer-review doesn’t, you know, play a, if peer-review can’t do it, you know, isn’t fast enough for him, then he should take it to the web, and he should send copies out to every pediatric, uh, you know, oncologist that there is

“That’s the way to do it”
======================================
DJT – Well, I’m sure, I’m sure Gorski would have a comment about that, as he’s commented previously about how he thinks uh Burzynskishould publish
======================================
1:57:10
——————————————————————
BB“It’s the, it’s the data itself

“If if Burzynski is is, is confident in his data, he will put it out there

“Right ?”

“One way or the other”
======================================
DJT – Like I said before

Like I said before on my blog, you know, even if Burzynski publishes his phase 2 information, Gorski can just jump up and down and say, “Well, that just shows evidence of efficacy, you know, it’s not phase 3,
so it doesn’t really prove it”

——————————————————————
1:58:04
——————————————————————
DJT – So then he can go on, you know, for however many years he wants to
======================================
2:01:00
——————————————————————
BB“Um, almost no treatment goes out without trials

“Massive amounts of data are required”
======================================
Bob, do you think that’s the 2.5 million pages of clinical trial data that Fabio said Burzynski sent to the FDA ? [10]
======================================
2:02:00
——————————————————————
BB“Uh, in in in that sense, you know, uh all the the the, you know, kind of back-peddling and and and trying to defend him is is going to, not going to help his case at all
======================================
Bob, exactly where did I exhibit any “kind of back-peddling” ?
======================================
2:03:03
——————————————————————
BB
“You are, honestly as far as I can tell you are doing the um, you know, you’re you’re ah throwing up uh, uh, uh, you’re giving me another uh invisible dragon in the garage, um”
======================================
DJT – Well y’all, y’all can call things what y’all want

I mean, y’all can give these, fallacy arguments and all that garbage that y’all like, because that’s what y’all like to talk about instead of dealing with the issues

I mean, Gorski doesn’t want to deal with the issues
======================================
2:04:11
——————————————————————
BB“Okay, so”

“What you’re telling me is that you trust the FDA to to be able to tell you when he’s not doing, good science, but also that you don’t trust the FDA”

“Do you see an inherent conflict there ?”
======================================
DJT – How did I say I, I didn’t trust them ?
======================================
BB“Well, when I, whenever I would ask about, like, why would these trials aren’t happening uh and, you know, you say well the the FDA’s arranged it

“The FDA’s in control”

“They sign off on these things”

“But they’re they’re they’re they’re at the same that they’re, they’re trustworthy they’re also not trustworthy depending on what you need for the particular argument at the time
——————————————————————
2:05:12
——————————————————————
BB – “You’re suggesting that they’re untrustworthy”
======================================
DJT – No, I’m just sayin’ that I’ve raised questions and none of The Skeptics wanna to uh talk about ‘em [11]
======================================
BB“Do you know that the FDA pulled out of the prosecution ?”

“Did you know that the FDA pulled out of the prosecution um of his criminal case, because they were backing a researcher ?”
======================================
Bob, would that “researcher” be Dvorit D. Samid, who was in Burzynski: Cancer is Serious Business (Part I) ?
——————————————————————
DJT – Well, we know a lot stuff they did, but that still doesn’t impress me that they pulled out of the prosecution

I mean
======================================
BB“Yeah, the the the it wasn’t the FDA who was pressing charges, it was a Federal prosecutor
======================================
DJT – Right
======================================
BB“Right”

“And and, they declined to provide information that the prosecution needed

“That’s important”

“That that that’s really important

“That he has been given the benefit of the doubt, and he has come up wanting, for decades now”
======================================
DJT – Well I find it interesting a lot of this uh, a lot of these letters that were provided between, you know, the government and Burzynski, when the uh phase 2 study was going on, at the behest of the NCI

You know, anybody who reads that stuff knows, that when you just ignore the person that’s been doing, do treating their patients for 20 something years, or close to 20 years, and you change the protocol without his approval, and you don’t use the drugs in the manner that he knows works
======================================
2:10:15
——————————————————————
BB“One of the interesting things about Doubting Thomas that I think you should definitely consider for yourself, is that at some point, when faced with the real opportunity to prove or disprove his assertions, he doubted himself”

“And that’s important”

“And that’s where you’re falling short in the analogy”
======================================
DJT – Well, I think The Skeptics, Skeptics are falling short because, you know, they don’t own up to
======================================
BB – “I’ve laid out exactly what it would take for me to turn on a fucking dime”

“I have, I have made it abundantly clear what I need

“Gorski has made it abundantly clear”

“Everybody else, Guy, and David, and Josephine Jones, uh, the Morgans, all of them have made it abundantly clear, what it would take to change our minds, and you’ve never done that”
——————————————————————
2:11:02
——————————————————————
BB“And even in this, this was an opportunity to do that

“To come up with a basis for understanding, where it’s like, you know what, If we can show this, you know, if we can show a this guy, that, that, there, that his standards are not being met, then, you know, we could possibly have some sort of ongoing dialogue after this”
======================================
DJT – So I can say that since the Mayo Clinic (Correction: M.D. Anderson) finished their study in 2006, and it took them until 2013, to actually publish it, then I can say, well, Burzynski finished his in 2009, which was 3 years later, which would give Burzynski until 2016
======================================
BB“Why wasn’t that study”
======================================
DJT – for me to make up my mind (laughing)
======================================
BB“Why wasn’t that, that that that, still . . again, it it doesn’t seem really to to approach the the the, main question here

“You know, um . . what are the standards that you have that it isn’t, what are your standards to show that it isn’t efficacious ?
——————————————————————
2:12:05
======================================
DJT – Well I can say, well I’m going to have to wait, the same amount of time I had to wait for Mayo (Correction: M.D. Anderson) to publish their study; which was from 2006 to 2013
======================================
BB“Why was the Mayo”

“Why was the Mayo (Correction: M.D. Anderson) study delayed ?”
======================================
Note how Bob ASSUMES that the publishing of the final results of the M.D. Anderson study were delayed
——————————————————————
DJT – How do you know it was delayed ?
======================================
BB“Well you said you had so many years before you finish it and go in”
======================================
DJT – I mean, has anybody
======================================
BB“Why, why did it take so long ?
======================================
DJT – done a review of when a clinical trial is studied, and completed, and how long it took the people to publish it ?

You know

If they could point to me a study that’s done that, and say, well here’s the high end, here’s the low end of the spectrum, here’s the middle
======================================
BB“I have something for you, okay ?”

“Send me that”

“Could you send me that study the way that it was published because um, just just send me the final study, um, to my e-mail address”
======================================
DJT – Sure
======================================
BB“Um, because, I can ask that question of those researchers, why was this study in this time, and what happened in-between”
——————————————————————
2:13:03
——————————————————————
BB – “Why did it take so long for it, for it to come out”
======================================
DJT – Sure, but that’s not gonna, you know like, answer an overall question of, you know, somebody did a comparative study of all clinical trials, and, when they were finished, and at, and when the study was actually published afterwards

You know, that’s only gonna be one, particular clinical study
======================================
BB“Right”

“Um, but it it would, perhaps, answer the question; because you’re using it as an example on the basis of which to dismiss criticism, whether or not, uh, it is the standard, and therefor you’re allowed to accept that Burzynski hasn’t published until 2016, or, um, it’s an anomaly, which is also a possibility, that most stuff comes out more quickly
======================================
DJT – Well, we know that the Declaration of Helsinki doesn’t even give a standard saying, You must publish within x amount of years,” you know ?

So, I’ve yet to find a Skeptic who posted something that said, “Here are the standards, published here”
======================================
2:14:07
——————————————————————
BB“I I, yeah, the other thing that David James points out is you know, why 2016 when he’s had 36 years already ?
======================================
DJT – Again, we get back to, when the clinical trial is finished, not when Burzynski started
======================================
BB“Treating people”
======================================
DJT – I mean, you would expect to find a results to be published after, the final results are in
======================================
BB – “You would expect the Burzynski Patient Group to be a lot bigger after 36 years, and in fact is
======================================
DJT – You would expect some people would want to have confidentiality, and maybe not want to be included
======================================
BB – “So, if you’re unsure about this stuff, if you’re unsure about the the time to publication, why are you defending it so hard, other than saying, “I don’t know, I really need to”
======================================
DJT – Why am I unsure ?
======================================
BB“Uh about the
======================================
DJT – (laughing) I just gave you an example
======================================
BB“The reasons, the reasons for which that he’s, no, why are you defending him so hard, when you’re unsure ?
——————————————————————
2:15:02
======================================
DJT – Oh, who said I was unsure ?

I just gave you an example
——————————————————————
Note how Bob ASSUMES that I’m “unsure” when I had the same answer since 0:32:07 [12]

Bob, who approves “Accelerated Approval” ?

1. FDA ?

2. A peer-reviewed scientific journal ?

3. The Skeptics™ ?

Bob, It’s your unlucky [13]
======================================
REFERENCES:
======================================
[1] – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/04/september-28-2013-the-skeptics-burzynski-discussion-by-bob-blaskiewicz-21951/
======================================
[2] – FDA grants Orphan Drug Designation (ODD) for A10 and AS2-1:
——————————————————————

Click to access PressRelease_12022008_BZYR(2).pdf

——————————————————————
josephinejones (@_JosephineJones), D Nile ist http://josephinejones.wordpress.com/2013/01/23/happy-birthday-dr-burzynski-and-goodbye-antineoplastons/comment-page-1/#comment-8921
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/23/josephinejones-_josephinejones-d-nile-ist-httpjosephinejones-wordpress-com20130123happy-birthday-dr-burzynski-and-goodbye-antineoplastonscomment-page-1comment-8921/
======================================
[3] – The Skeptics @Majikthyse reveals madjik research skilz:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/26/the-skeptics-majikthyse-reveals-madjik-research-skilz/
======================================
[4] – Critiquing David H. Gorski, MD, PhD, FACS http://www.sciencebasedmedicine.org/editorial-staff/david-h-gorski-md-phd-managing-editor/
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/21/critiquing-david-h-gorski-md-phd-facs-www-sciencebasedmedicine-orgeditorial-staffdavid-h-gorski-md-phd-managing-editor/
======================================
[5] – The Lancet Oncology
——————————————————————
http://www.thelancet.com/journals/lanonc/onlinefirst
——————————————————————
http://www.thelancet.com/journals/lanonc/issue/current
======================================
[6] – FINALLY, one of “The Skeptics™” has the “Balls” to do what even Dr. David H. “Orac” Gorski would NOT do:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/12/finally-one-of-the-skeptics-has-the-balls-to-do-what-even-dr-david-h-orac-gorski-would-not-do/
======================================
[7] – Burzynski – The Antineoplaston Randomized Japan Phase II Clinical Trial Study:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/28/burzynski-the-antineoplaston-randomized-japan-phase-ii-clinical-trial-study/
======================================
[8] – Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet “fact sheet”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/19/critiquing-national-cancer-institute-nci-at-the-national-institutes-of-health-nih-cancernet/
======================================
[9] – Stanislaw Rajmund Burzynski Publications:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/16/stanislaw-rajmund-burzynski-publications/
======================================
[10] – Critiquing: In which the latest movie about Stanislaw Burzynski “cancer cure” is reviewed…with Insolence:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/18/critiquing-in-which-the-latest-movie-about-stanislaw-burzynski-cancer-cure-is-reviewed-with-insolence-2/
======================================
[11] – QUESTIONS the Critics and Cynics, “The Skeptics™” do NOT want to ANSWER:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/23/questions-the-critics-and-cynics-the-skeptics-do-not-want-to-answer/
======================================
[12] – The Biggest Loser: “The Skeptics™” Guy Chapman (guychapman @vGuyUK @SceptiGuy) http://www.chapmancentral.co.uk/blahg/ – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/18/the-biggest-loser-the-skeptics-guy-chapman-guychapman-vguyuk-sceptiguy-httpwww-chapmancentral-co-ukblahg-september-28-2013-the-skeptics/
======================================
[13] – Burzynski: Why has the FDA NOT granted Accelerated Approval for Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal) ?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/28/burzynski-why-has-the-fda-not-granted-accelerated-approval-for-antineoplastons-a10-astengenal-and-as2-1-astugenal/
======================================

September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51

20131005-081923.jpg
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All comments by Professor Robert J. (Bob) Blaskiewicz of University of Wisconsin, Eau Claire “fame” should be considered as likely LIES until such time as he keeps his word to respond on this blog, to criticism of him on this blog
——————————————————————
“I hope somebody is writing all this down out there, so that we can go back and look at these claims later, right ?”
——————————————————————
1:19:00
——————————————————————
Seriously, Bob ?

Do you really think one of “The Skeptics™” was going to write all this down, when none of them showed that they had written down much of anything of much note about Burzynski 2 when they attended the screenings ? 🙂
——————————————————————
*Some words may or may not be missing, but it doesn’t take away from the final result
I will be adding separate critiques that break this down into manageable parts, but wanted to have entire video comments altogether here

——————————————————————
(0:04:38)
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Are you there ?
——————————————————————
Yes
——————————————————————
Okay, we might as well get started if were going to do this
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Okay
——————————————————————
(0:05:00)
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Alright, so ummm I guess we can start with uhhh bit of a conversation [0]

Uhhh

You’ve been on the Burzynski Hashtag for a long time – what’s you’re motivation ?
——————————————————————
Well as I put in my about page, I agreed with the juror that he was neither guilty or innocent [8]

So, so since I see all this opposition by these Skeptics, and I see that the they’re getting all of their facts straight

(Freudian sarcasm slip)

I decided to take the position of being a Skeptic Skeptic

In other words I am skeptical of Skeptics who do not fact-check their information before they post it on social media
——————————————————————
Okay
——————————————————————
And since I see ahhh y’all pretty much trying to take over the net with y’all’s information I decided to come back and correct all the false information that was being put out by other Skeptics
——————————————————————
So what information have Skeptics posted that they uhhh that they missed that demonstrates that Burzynski’s uhhh treatments are effective ?
——————————————————————
(0:06:00)
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What, what have we missed ?
——————————————————————
Well the major issue is that the FDA’s own information says if phase 3 trials are approved – phase 2 trials is to see if there’s evidence of effectiveness

And so if phase 3 trials are approved, that means you’ve provided evidence of effectiveness

That’s the FDA’s own information – I have that clearly on my blog [9]

Also the FDA has given Burzynski uhhh Orphan Drug Designation in 2004 for uhhh brainstem glioma and then in 2009 for all gliomas [10]

So that must mean that there is evidence of effectiveness, otherwise I don’t think they would be doing that

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0:07:00
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Well okay, uh one of the issues that Skeptics have with Burzynski is that in order to, let’s say, elevate uh the profile of his drug, in order to make sure that everybody who needs it can get, is to complete a phase 3 uh trial uh he started uh I believe was it just the one, right ?

Uhmmm, and that’s gone nowhere

In fact, it was withdrawn this I think within the last week

It doesn’t look like its going to happen, and this is, you know, for all the the phase 1 and phase 2 trials, those are very preliminary trials
——————————————————————
(0:08:00)
——————————————————————
Uhmmm, the phase 3 is is will be the gold standard, and also the bare minimum that that the larger medical community will accept uhhh as evidence, so it’s like you’ve lowered the bar for for evidence in a way that that you know oncologists don’t
——————————————————————
Well the issue is he was given 2 phase 3 trials that we know of

One was on uh Clinical Trials . gov – the one about eye cancer
——————————————————————
The the
——————————————————————
The vision cancer
——————————————————————
Right
——————————————————————
And then the other one was not posted on there, but then again the FDA has said, and I posted this on my blog because I specifically contacted and asked them and they said we don’t post all clinical trials on our web-site [11]
——————————————————————
(Correction: NCI)
——————————————————————
And so he obviously had that other one about brainstem glioma, that he was trying to get started [12]

But the other issue is that Skeptics have posted on there that he could not get that accelerated approval until he had published a phase 2 trial and that is exactly not the case because other drugs have been given accelerated approval before their results were published in phase 2 clinical trial publications, cuz, so that question remains as well [13]

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(0:09:00)
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9:13
——————————————————————
So, do you think that there is a uh uh conspiracy to keep Burzynski from publishing ?
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Well, what we do know is that in the movie, Merola showed that one page rejection from The Lancet
——————————————————————
Right
——————————————————————
where Burzynski was trying to show his results from like 8 to 16 years, and they said we think your uh publication would be seen best elsewhere, or some ridiculous statement like that

And so, I thought that funny of The Lancet [14]

20130930-164002.jpg
Of course, I understand their 2nd response, which came out, which Eric posted on his Facebook page, y’all, that y’all have talked about – that, you know, they’re busy, they get a lot of
submissions
——————————————————————
(0:10:00)
——————————————————————
I understand that, so obviously he would have to look for a different publication for both of those, things he’s trying to get published
——————————————————————
Clarification: Burzynski and Tsuda
——————————————————————
Right

So, uhmmm, as far as I understand it The Lancet, uhhh the the question of The Lancet publication ehhh is par for the course, that most people are, when they get a speedy rejection from a uh uh, uh journal, are actually uh grateful, because that means there allowed to go ahead and submit their material to another journal more quickly and get it out there

Uhm, but the reaction that we saw on the side of the Burzynski camp was that, see, they’ll never publish us
——————————————————————
(0:11:00)
——————————————————————
Uhm, which is, eg, taken as far as I can tell as evidence of a conspiracy or that his name is is poison uh I mean, I think it is, but uhmmm, that wasn’t indicated in the in the rejection letter in order to uh claim that it is is to go beyond the evidence which again we’re not really willing to do

So, uhmmm what is the the ration the the something that I think a lot of of a lot of The Skeptics have been curious about when it comes to your your your blog and your behavior on-line uhhh is that that that, that the format of your blog does not make sense to us, we don’t understand exactly what you’re trying to do with it

Could you kind of clarify that for us because it’s uhhh long and it’s it’s intense and there’s a lot of emotion behind it but we don’t understand exactly, what it’s supposed to mean
——————————————————————
(0:12:00)
——————————————————————
Well a lot of the time I’m making fun of y’all’s favorite oncologist, the way he words his blogs, and uhmmm I cite specifically from the FDA, from from the National Cancer Institute, from these other scientific sources, from scientific publications

I give people specific information so they can fact-check me, unlike a lot of The Skeptics who just go out there and say things and publish things on social media, they provide no back-up for their uhhh sayings

And so when I critique an oncologist or any other Skeptic I always provide source material so people can always fact-check me and I specifically said that people should fact-check everything ummm that the oncologist should say because he has, I’ve proven him to be frequently incorrect about his information and misleading
——————————————————————
(0:13:00)
——————————————————————
And so I’ve tried to add those things and allow people to search, on specific things like publications, or what I posted about The Lancet, or specifically about The Skeptics, or specifically about the oncologist

So whenever I see something posted new on Twitter, by y’all, sometimes I’ll check it out and sometimes I won’t, and sometimes I’ll comment on it
——————————————————————
Alright, ah have you read The Other Burzynski Patient Group ?
——————————————————————
I was, on there just yesterday to see some more of your post on there [15]
——————————————————————
So, ahmmm what is your response say to the story of Amelia Saunders ?
——————————————————————
Well the thing is, when you accepted this hangout, I published my newest blog article and I specifically listed all the information I had critiqued from you previously including Amelia, and I posted the specific Twitter responses by BurzynskiMovie; which is probably Eric, to your issues with Amelia, and he disagrees with what the oncologist posted, and so I pretty much let his Twitter responses stand to what the oncologist said [2]
——————————————————————
0:14:24
——————————————————————
Okay, what part of, what did I get wrong ?
——————————————————————
Well I also did a critique of the newspaper story that was put out about Amelia in the U.K. [16]

And they had 2, 2 patients that were dealt with

And
——————————————————————
Uh was that Amelia and Luna ?
——————————————————————
I believe, yes
——————————————————————
Luna was the other one, correct [17]
——————————————————————
And one of the patients, Burzynski has specifically published in one of his scientific publications that maximum dosage is not reached for a month
——————————————————————
0:15:00
——————————————————————
So if someone, so if someone only goes in there and has treatment for a month, they’re not even, you know, they’re finally going to reach the uh maximum dosage [18]

20131015-200045.jpg
And I think that was maybe the case with Luna, I think she was only there for a month

Oh, I, you’re talking, oh this is one of the very 1st ones that we did on the, on the site

Uhmmm, oh, her name is, her name escapes me at the moment

Um, but she wasn’t there for for very long but uh her condition deteriorated very rapidly

Uhmmm, and one of the questions that we had, we raised, is is, you know, you you don’t need to reach full dosage ’cause the the full dosage for these ANP seem to be pretty high, at least the sodium load that that that patients are asked to to carry, or required to carry if they they go on it

And we wondered if the sodium load was ah to great for someone who has a brain tumor, I mean uh, you know uh sodium load will increase your blood pressure, and these people have extra things in their brains that probably won’t react well to swelling, right, and and wont react well to pressure, so we were wondering, if in fact you don’t have to reach the full dosage in order to have uh severe side effects
——————————————————————
(0:16:00)
——————————————————————
Ummm, you know maybe you haven’t reached a therapeutic dose level, but that doesn’t mean that it didn’t have an effect on her

And you can clearly tell, that, you know in the videos, well at least the videos before the family took it down, that she was lethargic and a little bit out of it, she uh the the difference in her conscious state was no noticeable for anyone to see

Ummm, to, you know where she had been up and about to in her bed kind of slurring and and, and and and, in fact just disoriented, just looked like someone had taken the piss out of her
——————————————————————
0:17:00
——————————————————————
I mean, ummm, so that’s, that one, ummm, you know the critique that, reaching therapeutic levels and having a biological effect on someone are are clearly different things in her case

Uhmmm, now I never went on you know on to say ummm that uh she had uh reached therapeutic levels

Uhmmm, I I think as far as I went was that she went, she paid her $30,000 dollars and then she died

Uhmmm, and and and what part of that’s not true
——————————————————————
Well my only thing is, uh, we know that sometimes he will go to a maximum dosage, or you know, the suggested dosage, but he will back down off it, in fact in the uh adverse effects you mentioned those are specifically adverse effects mentioned in his publications, and when that happens normally they will subside within 24 to 48 hours is what it says once you take them off the treatment and let, you know, those conditions take care of themselves, and then you will slowly raise the medication again [19]

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0:18:33
——————————————————————
So, you know, it just didn’t tell, if only one month of treatment was enough to even start to do anything for her [20]
——————————————————————
Okay, so, um, going back to Amelia, um, some of the the most um I think the most serious charges is that we see a uh repeatedly in his uh uh stories of his patients, um those are all cited, those are all backed uh by, you know, um at least as good as anything the Burzynski Patient Group has ever done
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0:19:11
——————————————————————
Uhmmm, something that we see over and over are patients reporting over and over that signs of getting worse are signs if getting better

Um, in particular a, uh report that’s very common from from patients is that the center of their solid tumors are breaking up

One of the problems that we we we see is that that is more frequently a sign of ischemic necrosis that the tumor has outgrown its blood supply and that it’s dying on the inside

And when you see something like a 5th of the patients who we’ve been able to to document, reporting this excitedly, we get extremely concerned about what’s happening
——————————————————————
0:20:02
——————————————————————
Uhmmm, what part of that is not absolutely terrifying to you
——————————————————————
Well the thing is, the FDA has approved phase 3 <strong[12]and also given them the Orphan Drug Designation, which means they should have some knowledge about what’s going on, I would think [10]

Plus we don’t know for sure, we’ve heard about, ummm, some of the things supposedly the oncologist has talked about, which is cutting off the blood flow, to the tumor, which is something that some uhhh drugs can do, and I think that’s one of the things Burzynski has tried to do, ah he’s specifically mentioned it in his personalized treatment

But I don’t know for sure if it’s also something that’s done with the ANP’s in just the clinical trials environment
——————————————————————
0:20:02
——————————————————————
So, that could be a possibility
——————————————————————
Well, the the yeah I’ve never seen anyone say that the purpose of the antineoplastons is to cause uhhh, you know, to restrict the blood flow to the tumor and and and uh cause it to die that way, which is certainly one therapeutic approach that’s been, that’s been floated and research has been done on uh and might even be promising and uh what he’s saying is that cancer is caused by a lack of antineoplastons in the system and that basically what he is doing is antineoplaston uh uh supplement therapy uh rath, what’s the word I’m looking for, uhm uh, replacement therapy

Uh and there isn’t a doctor on the planet, uh not a medical specialist on the planet, who, I, who has identified at at as a contributing factor as a contributor to cancer or antineo or lack of antineoplastons

So
——————————————————————
Well
——————————————————————
Why isn’t he, you know, you understand that these doctors, ummm like nothing is true or false because a doctor says it is true or false
——————————————————————
0:22:26
——————————————————————
Uhmmm it’s it’s it but when the entire medical community uhhh who are des are desperately are are every bit as tired of seeing patients die uhmmm and seeing patients suffer or as anyone else’s families are you you imagine what an oncologist sees in that office over the course of of a year and there’s going to be unimaginable suffering

I’m sure that they’re tired of that

And that they would, you know, that if there was the slightest hint that antineoplaston deficiency was a cause of cancer that it would make it into the literature, with or without Burzynski
——————————————————————
0:23:10
——————————————————————
Uhhh ummm, why should we trust him when he has uh the sole uh the only person who had identified antineoplastons as a contributor to cancer when he is the sole manufacturer of the of the therapy uh when he is the uh sole prescriber of the therapy and when he is, where the sole distributor of the therapy from his pharmacy
——————————————————————
Well what I find interesting about these other doctors is like like the doctors mentioned in the movie and BBC Panorama’s report and in some of these newspaper articles where they are mentioned again is that these doctors never do a review of Burzynski’s scientific publications and including our favorite oncologist who refuses to do so [20]

Uhhh [21]
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0:24:10
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He’s read everything

I think
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Oh yeah he says he’s read everything but uh you know he claims that he’s uhmmm reviewed, reviewed uh Burzynski’s personalized gene targeted therapy but he, but then just a few months ago he admitted, you know, I don’t know where Burzynski says which genes are targeted by antineoplastons [22]

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And I pointed out which specific publications that Burzynski published, publications which specifically mention which genes are targeted by antineoplastons, and I said how can you claim that you’ve read and reviewed every Burzynski publication and you didn’t know which genes are targeted by antineoplastons when that’s specifically in the publications ? [10]

To me that tells me that you do not know how antineoplastons work be because you just admitted you don’t know which genes Burzynski talks about

I mean that’s just funny as heck to me that he would say that
——————————————————————
0:25:07
——————————————————————
Can you go ahead and send me that link that that I saw in the chat that you had uh posted a couple of times in the chat

Could you send me that link, to that publication

I can give you a minute to to go find it if that’s
——————————————————————
Well I’ve, I’ve got it on my blog

Uhm

I mean I can forward it to you at some point
——————————————————————
That would be good

Uhmmm
——————————————————————
But I agree with you about I don’t remember seeing anything about antineoplastons cutting off the blood flow to the, you know the blood brain barrier for sure either
——————————————————————
Well, yeah that’s a, that’s you know one of the major problems that this this cancer has is the location is such a pain to get to

Uhm, and often when we are talking about these cancers, the thing that gets me over and over and over, and this is something that I’ve learned from from working uh with others on the Burzynski Patient Group is what’s it like to be a cancer patient, only by proxy, man I couldn’t imagine really going through this myself, and, you know I’d hate to see my family go through this
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0:26:22
——————————————————————
That these people are at what could be described as a low point, they’re um uhhh, you get a diagnosis of uh brainstem glioma the prognosis is very bad

Uhmmm, there are only a few cases of people recovering from that, I mean they’re there uhm uhhh but, you know that it’s an, it’s an extremely grim prognosis

Uhhh and I worry that when they’re in that desperate state and especially let’s talk about the children, you have these kids who are uh you know 2 and 3 and have had this, you know uh awful diagnosis and the parents are willing to do literally anything to keep their kids alive
——————————————————————
27:16
——————————————————————
What protections are in place for patients as far as that these kids are and and their parents are protected
——————————————————————
0:27:30
——————————————————————
Well I think i know the point that you’re getting at uhhh about the IRB’s and all that good stuff

All I can say is that, you know the FDA can come in with any amount of investigators and say that you did this or that but you have the opportunity to respond, and so they can pretty much say anything, it’s only when the final report comes out that you can take that to the bank

And so all this speculation about what a investigative team may say about the clinic is, to me just like someone going into a lawsuit and saying so-and-so did this, you know, can you prove that, you know, did so-and-so do that [23]
——————————————————————
0:28:09
——————————————————————
So it’s the same thing with the FDA, these um little reports, the final report is what counts, and so, also what I find interesting is some of Burzynski’s publications specifically said, you know this particular uh clinical trial, the IRB was agreed upon by the FDA [24]

Well if if the FDA agreed upon it, you know, then some questions should arise about exactly what did the FDA agree upon

What would we find out from a Freedom of Information Act request on that ?

And, and what I also found interesting is when I did research on other clinical trials for brainstem glioma I found, you know, all these other science based medicine studies where 374 children had died in their studies [25]
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0:29:00
——————————————————————
And what I found interesting is back in 1999, they reported on a clinical trial, they had better results then all these clinical trials afterwards [18]
——————————————————————
Who had the better results ?
——————————————————————
Well, I would have to find you one, there were like 3
——————————————————————
Okay
——————————————————————
There were like 3 major ones that Burzynski has mentioned in his publications to cross-reference his trials versus their trials as far as the results

And so, I, there was one back in 1999 that had better results than a lot of these clinical trials that come afterwards

So when we talk about, you know, what’s really right for the patients well we can see that the drug companies want to test their drugs through clinical trials and, you know, and if your kid dies, well, unfortunately the kid dies

Even though we showed better results in 1999 with a different type of treatment, you would have thought that maybe they would have poured more investment into that particular treatment but that’s not necessarily how the clinical trial system works
——————————————————————
0:30:00
——————————————————————
Hmmm, yeah, the, Guy Chapman has just um uh tossed in a a, a comment

I guess uh that there are a lot of people who wanna talk to you (laughter)

Uh, Guy Chapman has just jumped in and said it looks like you forgot the phase 3 trial is withdrawn and none of the phase 2 trials were published

Uhmmm, this, this is not a minor thing for for for Skeptics

This, this is exactly what will convince us to get on board the Burzynski train is the publication of these trials

But even the preliminary trials, one has been finished, and none has been published in its entirety for over 15 years

When you consider that this is a, as you just pointed out, this is a a cancer, the, especially the brainstem gliomas

That these cancers uh the cases resolved fairly quickly, we know what the outcome are fairly quickly
——————————————————————
0:31:00
——————————————————————
Ummm, do you have any sense of when these trials are going to be published ?
——————————————————————
Well here’s my point, I mean, y’all probably get a better sense from, ummm, Hymas, about what’s going on with that
——————————————————————
From Laura ?
——————————————————————
From her uh fiancé, or husband, whatever his status happens to be right now (laugh)
——————————————————————
Right
——————————————————————
And uh also from Ric, uh they’re more closer to Burzynski than I am, because I have never met Burzynski, I have never e-mailed Burzynski, uhmmm never talked to Burzynski, never met him, blah blah blah

Uh, my sense is that since 1996 when the FDA talked about antineoplastons, that specific FDA Commissioner that was in charge at the time, he set out 7 major points about how there was going to be less people required and there was going to be less paperwork, there was going to be less stringent things about Partial Response [26]
——————————————————————
0:32:07
——————————————————————
And so, to me, the FDA is the final source to go to when people want to complain about how long their trials have lasted uh because the FDA is bottom line, you know, in charge of that

And
——————————————————————
When you, when you think about a major, sorry, go ahead
——————————————————————
And my other point is that, uhmmm, when these trials finish, as I’ve pointed out on my blog, M.D. Anderson finished a trial in 2006 and didn’t publish the results electronically until January of this year [27]

So, just think

Burzynski’s 1st trial we know that finished in 2009

So we would still have more years to go before he caught up to M.D. Anderson as far as publishing

So for him to actually be trying to publish stuff now and The Lancet not publishing because they have other stuff to do, put in there, that’s understandable
——————————————————————
0:33:03
——————————————————————
So, we know that he’s trying to publish, uh but they’re going to keep it close to the vest obviously, from, from how they do their things, and where they’re trying to publish

And plus, like I’ve said before
——————————————————————
Yeah, right, uh
——————————————————————
We’ve still got the accelerated approval thing that’s out there, you know, like the FDA’s given Temodar and, and Avastin, and another drug, whereas they’re not doing the same thing for antineoplastons, eve even though for all intents and purposes from what we know, antineoplastons have had better success rates than Temodar and Avastin when they were approved [13]
——————————————————————
Antineoplastons has a better rate ?
——————————————————————
Well from the information that’s been published in certain um publications
——————————————————————
Right
——————————————————————
And in, and in not only Burzynski’s but elsewhere in, in newspapers or articles, or such like that
——————————————————————
Right, one of the things that that there there are 2 points to be made here

Uhm, the 1st one is that major pharmaceutical companies that are getting this accelerated approval have a track record of producing results which Burzynski does not have

Secondly, when it comes to ummm the rates of antineoplastons, how can we possibly say without a single published trial he, that he has an improved rate over Temodar or anything like that, and that’s exactly what would show to us whether or not his rate is better, the the types of publications that he’s done, that look really good on paper, ummm, to the to the, the common persons eye are these case series where he goes through and picks out people who have happened to have survived
——————————————————————
0:34:47
——————————————————————
But what that doesn’t tell us is whether or not the antineoplaston had anything to do with it

What you need to do is go and separate the background noise, the random weird rare but very real survive, unexpected survivals that occur, and separate those, uhhh, from any effect of antineoplaston, he’s never done that
——————————————————————
0:35:10
——————————————————————
Well what I found interesting is when the FDA approved these other 1 or 2 drugs, some of them specifically said that, uhhh, some of these drugs had, you know, better survivability or they showed no better rate than any previous treatment but we’re approving it anyway [13]

Basically that’s what the publication said and I published this on my blog in an article specifically about, you know, those 2 or 3 drugs that the FDA approved for brainstem or brain related cancers [28]

And so, you know, I’m not going to buy that argument about that, about that specific thing
——————————————————————
But if you think about that, I mean that if it does have a a an improvement rate above uh other treatments
——————————————————————
0:36:03
——————————————————————
That still has an improvement rate, you know, that, that would give another option to people, ummm, even if in the aggregate their rates aren’t better

It might work on some individuals tumors rather than on, you know, you you it it is it taken as a, as a lump but extend life by uh quality of life for 3 months or something um in some cases but, you know, it it still has an effect, a real effect, and deserves to be out there
——————————————————————
Well one of these newspaper articles specifically said, you know, Avastin would maybe keep you alive for maybe 4 more months

So, you know, take that [2]
——————————————————————
That’s a long time when someone is dying
——————————————————————
Well, we can wonder if some of Burzynski’s results are the same, otherwise why would the FDA say, you know, give the ODD [10], why would the FDA give the phase 3 approval [12]
——————————————————————
0:37:02
——————————————————————
Plus I don’t buy some of these doctors coming out and saying stuff, they have the opportunity just like the other doctors in Egypt [29], in Russia [30], in Germany, in, in Poland [31], in China [32 – 33], in Taiwan [34] that have done antineoplaston studies, I’m like, these people can do antineoplaston studies so what’s the excuse for all these other doctors who say that they supposedly can’t do them

You know, the information’s out there and
——————————————————————
Well, one of
——————————————————————
and like these other doctors can do it
——————————————————————
One of the problems that that doctors have in in this country when it comes to doing ummm antineoplastons studies to verify any any effect that uh Burzynski has uhhh I i think back to the one where people say well that the FDA sabotaged his trials, and
——————————————————————
Well, we kind of know that that’s a fact [35]
——————————————————————
Clarification: NIH, NCI, and the Investigators
——————————————————————
Well, if if you think about it though, um, the, the proposed action as I understand it of the antineoplaston is that it’s a deacetylase inhibitor, which slightly unspools DNA, that allows uh, which would allow uh proteins to get into a pair of damaged DNA

And we have drugs that do that which carry a much lower sodium load

Uh, um, it, that would have a therapeutic effect on and that the risks outweigh the possible benefits of using this one particular drug

Um, I’ve seen any number of people looking at um, if you look at the Luna ah Pettiguine uh uh story on The Other Burzynski Patient Group um you see that the doctor is absolutely horrified by the insane sodium load that that Burzynski’s patients are carrying

Um in in some ways that that sodium load is uh leading people to constantly drinking up to I’ve seen 12 liters of water a day
——————————————————————
0:39:11
——————————————————————
That’s not necessary for other deacetylase inhibitors

Um the, why would you prefer that to to another drug if it did essentially the same thing, that didnt have this massive side effect ?
——————————————————————
Well what we know from 1996 from Burzynski’s own information that he’s published, is that not only does he have the original parent antineoplastons, but he’s developed 2nd and 3rd generations, but he can’t just stop in the middle of his clinical trial and use the 2nd and 3rd generations which may be better [36]

(Clarification: 1997)

He can't uh use these other types of um antineoplastons that other researchers, researchers like Egypt [29], or Japan [37] have found um that may be better because he can’t just switch in the middle of the clinical trial
——————————————————————
0:40:04
——————————————————————
Now if he, if the FDA approves his product, well then, maybe he can roll out the 2nd and 3rd generation and these other types of antineoplastons that may be less harsh, but that’s all he’s got to work on and that takes us back to the FDA, having control over the entire process, as far as the paperwork, how many people are in the trials, etcetera
——————————————————————
Well that sss I believe that that’s proposed by the researchers, the design trial, you know they they sign off on it but that is is, is up to uh Burzynski uh my uh David James @StortSkeptic on the [38]
——————————————————————
Right
——————————————————————
ah he has asked everything that Burzynski does looks sort of like the behaviors of pseudo-science
——————————————————————
0:40:56
——————————————————————
So what we’re saying uhhh he does uh uhhh Burzynski like for instance like I said he has vertically integrated, ah, he controls all parts from identification to the creation of the drug uh to the diagnosing uh well he doesn’t do the diagnosing but he does um um prescribe and distribute, he does all that vertically, which is actually something that snake oil salesmen do
——————————————————————
0:41:32
——————————————————————
Another thing that that’s a red flag in Skeptic circles is that his one compound seems to be a sort of panacea for all sorts of different types of, of of cancers, um where we know that cancer has a a varied uh, uh, ideology and and the uh panaceas are are are to be and a variety of different types of causes um, in fact in any one tumor you would, you could say that these, these tumors are are completely uh heterogenous

The idea that there’s gonna be one knockout, it seems rather unrealistic

Um, additionally he charges immense amounts of money for this drug, um, even though the components cost pennies

Um, on top of that, um, there’s something that he asks for a a huge payment up front
——————————————————————
0:42:33
——————————————————————
That’s something that’s been warned against for generations of uh by anti-quack um uh crusaders if if they’re asking for everything up front, then be afraid

Ummm, another thing is that uh the kind of cult that’s sprung up around Burzynski, uh, one that is immune to uh criticism, reason, and pits people who are doing standard cancer research, as enemies, um, creating a black and white version of the world where there are good people and there are bad people
——————————————————————
0:43:15
——————————————————————
There are people who are fighting the disease, and then there are people who are really helping the disease

I mean, if you look at the, the new web-site by the Burzynski patients fighting back group, they say support the cure not the cancer

That’s a manikin world-view of black and white
——————————————————————
0:43:30
——————————————————————
Um, these are all huge red flags, that you’re dealing with a quack

Um, why hasn’t Burzynski done anything to change that ?
——————————————————————
Well I find it interesting that you talk about the cost, because I’ve done a lot of research about the cost, and I was just looking at the cost again this morning, and put it into that particular blog article I was talking about, that I did for this particular program [39]

And, um
——————————————————————
0:44:00
——————————————————————
The thing that’s funny is that people can say, ohhh Burzynski charges a lot, but the fact is, so does chemo, radiation, and some of these newspaper articles that have been published, and specifically in the movie, Burzynski 2, one of the people mentioned how much someone was paying for standard treatment

And I noticed our
——————————————————————
Right
——————————————————————
favorite oncologist didn’t comment about that in his movie review [40]
——————————————————————
Well, there, this is important

This is really important though

Wha, when she’s talking about, that’s Luna Pettiguine’s mother, is is talking about the costs there

Uhmmm, you, when someone is not insured in in this country,

Ahm, the, the the base cost that that’s calculated is, is the hospital only expects to get a fraction, a tiny fraction of that back from the insurance companies, and that’s why the costs are so inflated

Um, usually, when a patient is self-pay there is a self-pay price which is a more reasonable price
——————————————————————
0:45:01
——————————————————————
Additionally, all of those therapies, have demonstrated efficacy, and if Burzynski were to demonstrate his efficacy, $30,000 dollars to start on a life-saving treatment for a child would be a steal, and he would earn every nickel of it

Um, so, those arguments hold very little weight with us
——————————————————————
Well what I find interesting, you know, I’m not sure how people think he’s supposed to pay for the clinical trials, you know, if he’s supposed to go into debt, millions of dollars
——————————————————————
He has a a an enormous house that’s valued in the tens of millions of dollars, he could do that if if the other, the other thing he could do, and this, we would love to see him do this, wousa, would be apply to Federal grant

That, that would be amazing, if he could get a grant to study this stuff

But, you know, um, I I don’t think he’d be able to get one, I don’t think he’s shown uh that he can carry off a uh a research program responsibly
——————————————————————
0:46:08
——————————————————————
Uhmmm
——————————————————————
I find that funny considering the FDA approved phase 3, has given him ODD for brainstem glioma and also also all gliomas [12]

You know, that’s kind of ridiculous [10]

And the people
——————————————————————
Well
——————————————————————
gettin’ off about his house, well who cares ?

They don’t know where his money came for that particular source
——————————————————————
(Clarification: “They don’t know the particular source where his money came from for that house”)
——————————————————————
Oh he, have you noticed the the, the thing on his web-site where if you make a donation to the clinic it goes directly to him ?
——————————————————————
Well, you know, when you have good tax lawyers your tax lawyers will tell you how to structure things, and everybody in America has the right to structure their taxes in a manner that effectively serves them according to our Supreme Court

So, if you have a tax lawyer who tells you, hey this is the best way to do it, to save money, well, you may do that uh based upon your lawyer’s advice
——————————————————————
0:47:00
——————————————————————
So, maybe Burzynski has taken his tax lawyers advice, just like I’m sure he’s taken Richard Jaffe’s ad advice (laugh), which has proved well, for him
——————————————————————
Right
——————————————————————
You know, you know

That’s another thing
——————————————————————
Ummm, o-kay

Uh, I want to turn this over to the people who are watching

Um, I want to give them a a chance to address you as well

Uhmmm, hi everyone

Uhmmm, so, um, let’s, let’s wait for for that to roll in, and I do wait to go back to the, the the, the and let’s be very specific about this, the the things that you see on The Other Burzynski Patent Group, a patient reporting that um uh getting worse is getting better

How do you explain that ?
——————————————————————
0:48:00
——————————————————————
Well I guess we could ask, you know, Ben and Laura Hymas [41]

What was their experience, you know ?

Did they have, did she have to drink uh a lot of water because she was thirsty ?

You know, did she have to drink a lot of water due to the high sodium ?
——————————————————————
Well that’s just a known side-effect, your going to know that going in, but we actually have people say
——————————————————————
So I would ask her about her personal experience instead of saying, you know, instead of quoting some of these other people
——————————————————————
Are there, why why why not, these people, see this is the thing though

The reason that site was started was because the people that don’t make it don’t have a voice

And when you, when you whittle away, when you only look at the at the, the positive outcomes, which is exactly in Burzynski’s favor to only look at the positive outcomes, and to have no sense of how other people’s diseases progressed, right, you’re gonna get a skewed and inaccurate version of the efficacy of this particular drug

Now lets lets lets go back and not talk about Laura, lets talk about these patients who report symptoms of getting worse, as if they were signs of getting better

Some people say that oh it’s a healing crisis or it’s progression of the disease

Or other people say it’s breaking up in the middle, hurrah
——————————————————————
0:49:20
——————————————————————
No, it’s actually a tumor that’s growing

That record there, that’s being left by patients, whose stories are every bit as important as the as the stories of the patients who have lived, are painting a completely different picture

How do you explain that ?
——————————————————————
Well we all know the FDA is in charge of this, and so hopefully they know what’s going on
——————————————————————
Are they feeding these people their stories ?

Are they feeding these people their stories
——————————————————————
No, I’m sure the FDA can look at the records because Burzynski sent them 2.5 million pages according to our friend Fabio [42]

20131015-215557.jpg
0:50:00
——————————————————————
And uh, you know just something the doctors who came in and did the little ol’ one day, 6 patient records, where they reviewed all the records and slides, and MRI’s, etcetera, you know they can do the same thing, the FDA can do the same thing with all these patients [35]

(Clarification: 7)

And see the same MRI’s and scans, etcetera

I mean, we, we know that with all these 374 children I mentioned dying in other science-based medicine clinical trials [25]

I mean, they, FDA probably went through all their records

And, so, all these people didn’t look good either but, you know, the FDA still gave approval to Avastin and Te Temodar even though a lot of people died in their clinical trials [25]
——————————————————————
Okay I’m going to go back, I want to point something else out to you

Um, I have to, I don’t remember the exact patient so I have to go back to my web-site to take a look at it

Um
——————————————————————
0:51:00
——————————————————————
Because we are, because we’re on a Google+ stream that that’s a lot of data it takes awhile to bring up my, my site

Let me

Uhmmm
——————————————————————
I mean, we could agree that since Burzynski’s publication says that it’s going to take a month to get up to required dosage, and so we know, the tumor can still grow, like he said, up to 50%, he specifically acknowledges that in his publication, so, we know that can happen [43]
——————————————————————
0:51:35
——————————————————————
Well, that seems to give him an instant out, no matter what happens

That turns his claims into something that’s unfalsifiable

If I could give you an example of what unfalsifiable is

Um, and I’ll I’ll draw an uh, uh, case, uh hypothetical case of um uh proposed by Carl Sagan as the invisible dragon in your garage
——————————————————————
0:52:00
——————————————————————
If you say you have have a dragon in your garage, um, you know, you should be able to go over and verify that there’s a dragon in the garage

So let’s say we go over to Carl Sagan’s garage and, you know

Well, I don’t see anything

Well it’s an invisible dragon

Well okay, well then, let’s uh spray paint it

Well, it’s incorporeal

Well, uh, let’s measure for the heat of the breath

Well it’s heatless flame that it breathes

And, you know, okay, well then we’ll put flour down on the ground to see that it’s it it’s standing there

And, oh no it’s ah it’s floating

Well, you know, at some point, when you can’t falsify something

When you cannot, even in principle, prove something false, it’s indistinguishable from something that’s not there

And that kind of out, that oh well the tumor can keep on growing

Th (laugh) that that that’s an invisible dragon, as far as I can tell
——————————————————————
0:53:00
——————————————————————
Well we know from his own publications, he says he can’t just go in and start giving the maximum dose, or recommended dose right off the bat because a particular condition will occur, and he specifically mentions, in the publications what that condition is, I don’t remember it right off the top of my head [20]

But then again, his 2nd generation, his 3rd generation, his other form of antineoplastons that may work in the future, if approved, well those could possibly (not) have the same uh adverse effects that the current parent generation have [36]

But we don’t know, and like I said the FDA I’m sure knows because they have all the records, we don’t have them, and so unlike our favorite oncologist I’m not going to speculate, about what the FDA knows and I do not know
——————————————————————
A every time that I and and and and , and David points this out, that um, you you know your not going to speculate about the the FDA but then at every turn your invoking the FDA as being obstructionist
——————————————————————
0:54:02
——————————————————————
I, I just find that to be contradictory and and self-defeating

Um, let me see
——————————————————————
Well we know they stopped this particular trial, supposedly because a patient died

So what’s the hold-up ?

I mean, hopefully they’ve done an autopsy

What was found
——————————————————————
Well, that’s not necessarily true
——————————————————————
No
——————————————————————
I mean uh when it when it comes to the case um I’ve i’ve talked to oncologists about this

And when it comes to uh for instance in in this case it sounds like it was a pediatric patient who was dying, ummm, who had died, ummm, the,
the 1st inclination is to ascribe the death to, um, to the tumor, which actually, would be to Burzynski’s benefit if there were other cases, I’m not saying there were, but if there were other cases where this type of complication arose, and it was ascribed to the tumor they might well not do it, uh, do an autopsy

——————————————————————
0:55:08
——————————————————————
Um, it’s ah as you could imagine it could be very difficult for the families to do that especially when they have ooh ah, a possibility of what, you know, led to the ultimate demise, that didn’t involve them ultimately somehow being responsible for it, right?

So, it it it doesn’t seem to me that necessarily an autopsy would be um a a done deal

Um, let me see
——————————————————————
And we don’t have a final report from the FDA on what the findings were
——————————————————————
No we don’t and it would be irresponsible to completely speculate on on, on, the outcome of that uh, uh, uh, individual patient, I am still scrolling through looking for this story that I wanted to talk about
——————————————————————
0:56:00
——————————————————————
Uh, and, I guess I’ll

It should be in Amelia’s I I, I packed Amelia’s story with all the stories, um, that I could find um in what we’d written up already

Um

Hold on a sec

She is a cute kid though

Um, alright

Now, our favorite oncologist (laugh), as you keep putting it, um, uh, with with the Amelia story, um, uh, was able to correctly determine that the Saunders family, had a, did not understand the significance of this cyst that had opened up in, uh, that had opened up in the center of the tumor, in fact they were ecstatic

They were delighted

Um, the family, of Haley, um, S, also
——————————————————————
0:57:10
——————————————————————
Uh, the the family of Haley S., also, had the same reading given to them

Um, the same diagnosis uh same prognosis was to, was given to Justin B in 2006

A similar cyst in Lesley S’s story uh ah, was in 2006

Um, and that kept her on uh treatment for a a another month so that could be another $7,000 some odd dollars

We same thing in the, in the case of, uh, Samantha T in 2005

We see it again as far back as 1994, in Cody G’s story

And then lastly and and the worst uh thing that we’ve seen, the patients report that Burzynski himself told Chase uh Sammut
——————————————————————
0:58:00
——————————————————————
The exact same thing

Um, and that was a

Have you read Chase’s story
——————————————————————
I don’t remember specifically

Possibly not
——————————————————————
It would stick with you, because that case is grotesque

The parents, uh, there was even a uh, uh, a fight over whether or not the parents should be allowed to continue treating this kid

He was basically lying, uh, in a uh uh brain dead uh for all intents and purposes, uh, in a in a coma uh without possibility of reversal, in his parents living room for months

Um, eh, all the while, he’s still on the, uh, we’ll I don’t actually, I can’t say that, I don’t exactly know if he was on the treatment the whole time

Um, but, we do have this pattern, that is there, of people believing, that this particular pattern is, uh, progress, a a is not progression of disease but is is inducement to to stay on, um, eh, and this has been going on for decades

Eh, eh just based on what we’ve been able to find that patients have been reporting this for decades
——————————————————————
0:59:20
——————————————————————
At some point, you would think that a doctor would realize that perhaps what these patients are walking away with is inaccurate

Why hasn’t that changed ?
——————————————————————
Well he’s using the same 1st generation drug
——————————————————————
E wel that that that that’s not it

This is this is like the 2nd day of oncology class, that that’s what the tumor looks like

People are reporting that the tumor is no longer growing, um, or that the growing has slowed after they’ve started

Well, okay

There, there is an explanation for that, and why you can’t take that as necessarily being evidence of efficacy
——————————————————————
1:00:00
——————————————————————
Ah, the tumor grows exponentially while the resources are available to it, but then it reaches a point where it’s a self-limited growth, so it, the time between uh doublings in size decreases logarithmically

Um, so this is, this is like basic tumor physiology that we’re talking about, and his patients don’t leave his office, knowing these facts, for decades

This doesn’t have anything to do with the, do with the drug

This this
——————————————————————
Well I’m sure a lot of people leave the doctors office not knowing things (laugh), for decades
——————————————————————
But, but when it’s, this treatment is working or this is not evidence that the treatment is working

That’s pretty basic

I mean we’re not, we’re not talking about deacetylase inhibitors or anything like that were you’d really need to know something about

This is, whether or not, you’re getting the outcome that you want
——————————————————————
1:01:00
——————————————————————
This is the whole reason for going

And it has nothing to do with the with the with the drugs
——————————————————————
Well we know the contin, the tumors can uh continue to grow for awhile, at least, and certain effects that they probably would
——————————————————————
Which is, which is like which we just pointed out was a was an invisible dragon
——————————————————————
Well I’m sure, I mean, it’s going to continue to grow, in any other clinical trial too, for a certain awhile

I mean like
——————————————————————
you’re you’re you’re assuming

You’re you’re you’re assuming that

You’re assuming that

Um, I’m not assuming that
——————————————————————
Well we know that all these other kids died in these science-based medicine trials, and, you know, we can assume that that was the case there too [25]
——————————————————————
1:02:00
——————————————————————
Ultimately it would, but whether or not it it it had a genuine therapeutic effect is a different matter all together

Um, this, what would, what would convince you that you’re wrong
——————————————————————
The FDA not giving him phase 3 approval [12], the FDA not giving him ODD designation [10]
——————————————————————
So you’re saying because the Orphan Drug Designation and the face that there’s a phase 3, therefor it works ?
——————————————————————
And showing that, and showing the FDA that there’s evidence of effectiveness [11]
——————————————————————
So what you’re saying is there’s nothing that would convince you now, that it doesn’t work
——————————————————————
Not until the FDA says it doesn’t work
——————————————————————
O-kay

Um, it’s it’s it’s not the FDA’s, but you understand it’s not the FDA’s job to tell someone that their drug doesn’t work
——————————————————————
Well they seem to be doing a good job of it
——————————————————————
1:03:00
——————————————————————
it’s it’s it’s up to Burzynski

It’s up to Burzynski to show that his drug does work

And it’s always been his burden of proof

He’s the one that’s been claiming this miracle cancer cure, forever
——————————————————————
Well I’m sure, I’m sure they wouldn’t have done things if they didn’t see some evidence that it was working
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Um, I don’t know if you’ve read Jaffe’s book
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No I haven’t read it [44]
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There seems to have been a lot going on there you really should look at it because it’s it’s it’s kind of revealing

Um, that that that it seems that there was a lot of political pressure applied to the FDA which may have been, uh, uh, have influenced the way in which these these trials were approved

I I would say that it is a genuine con uh uh bit of confusion on the parts of Skeptics

We don’t know why the phase 3 trial was approved

I don’t know that we’ve seen even the phase 1 trials, we don’t know why he’s getting a phase 3

And there’s a real story in that, we think
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1:04:02
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Um, that we’d love to see, however we can’t see, however we can’t see it because of proti protri proprietary uh protections that the FDA is giving to Burzynski, right ?

They’re not sharing his trial designs because they are his trial designs, right?

That the makeup of his drug that he’s distributing are his, uh design, and his intellectual property

So the FDA is protecting him, uh from outside scrutiny

While you may imagine that that, that that the FDA is is somehow antagonistic toward him

They’ve given him every opportunity, over 60 opportunities to prove himself worth uh their confidence and hasn’t

Um, but I definitely recommend that you look at Jaffe’s book and you will see, I think, um that um it’s called um, uh Galileo’s
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1:05:00
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I know what it’s called [44]
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You know what it’s called, okay, yeah

Um, definitely look at that

Um, you, you will see, the ways in which, the way that we got to this point, isn’t necessarily having anything to do with the efficacy of the drug

That comes across very clearly

Um, you, you mentioned it yourself, he he’s done well to listen to Jaffe’s advice, right ?
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Right
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So, there there’s a lot to that

Um, uh, but yeah, let me go back to the Twitter feed

Um
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Well I’m just gonna say, you know, the F, the FDA doing what they’ve done, since they approved those 72 initial trials, pretty much speaks for itself [45]

I mean they’ve had every opportunity to shut this down, since then
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Well it sounds to me like they’re they’re not um, the the the you know, they’ve put the clinical hold on now because they now have evidence that somebody may have died because of the treatment
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1:06:06
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Um, I don’t know what the state of that is right now

Um, uh, oh my gosh, um, let me see

Someone has just sent me a, a ah a link to, are you following the Hashtag, as this is going on
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No, I’m just concentrating on what we’re doing
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Okay

I’m doing, I’m doing the 2 things at once and it’s um, ok ok well it’s well ok I can’t I can’t go in and read that right now

Um, I would, ok let me tell you exactly what it will take, for me to come around and promote Burzynski

Um, for me, he needs to get a publication in a uh, yeah, uh uh uh publication in a peer-reviewed journal, a respected peer-reviewed journal, not like the the Journal of Medical Hypothesis or things we just made up
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1:07:16
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Um, something, you know, a a good, respectable journal that oncologists would read, that research oncologists would read

I would need an completely independent group to replicate his findings, and then I’d be all for it

I would say that right now, the business model that the Burzynski Clinic seems to depend on, as best as I can tell from an outsider, that, um, uh, that it depends on people paying money up front

It doesn’t depend on him developing and taking away a viable drug, that he can market to the entire world

His business model as best I can tell, is to keep it in house
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1:08:03
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That seems, if it works, if his drug genuinely works, and he hasn’t sent it along to mass approval, where he gets, for a couple of years at least, you know, exclusive rights to produce and sell this stuff, for one of the most intractable diseases, uh that man eh can can can, you know, can get, um, that suggests to me that there’s something else going on here

Now, someone has just sent a a note, uh that he has failed 3 different Institutional Review Board audits; this is Guy Chapman (@SceptiGuy), uh no other institution has a 3 for 3 fail, according to to Guy iye he knows no other one

Um, that 45% of phase 3 clinical trials fail due to deficient phase 2 design

Um, he has an approved phase 3, but phase 2 was deficient so phase 3 fails
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1:09:07
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Do you think that that could possibly have anything to do with why we’re not seeing the phase 3 advance
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Well #1 I don’t think the one with brainstem glioma where they wanted to use radiation with ANP was really the right way to go, I mean he’s already proven that uh he seems to have better results without [12]
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He’s claimed
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first starting radiation [20]
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He’s claimed

That’s a different thing altogether

And in fact
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Yeah but the thing is radi, I, the FDA was not saying, ok, one study, one side of the study we’re only going to use ANP, in the other side of the study we’re going to use radiation and and ANP like like they would normally do

No, they wanted to make him use radiation in both sides of the study [20]
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Well, you understand why they do that, because in order to, it’s
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They don’t do that with other drugs [13]
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No, they do do this with other drugs, well, it depends on the type
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1:10:01
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Some drugs it’s ethical to give something completely questionable, what they want to make sure that they at least get the standard care, you know which includes radiation

Um, and radiation does seem to extend life, reduce the size of some tumors some times

Um, do you concede, that in order to have a phase 3, you do not need to have a successful phase 2 ?

When 45% of phase 3 fail because they have a deficient phase 2 design, do you concede that ?
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Well I don’t buy anything Guy Chapman sells, considering his past record [46]
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Well, ok

It doesn’t matter where
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(laughing)
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It doesn’t matter where it comes from uh, um
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Well his theories are suspect, anything he hands out, let me tell ya [47]
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So-kay, um that would be shooting the messenger as opposed to dealing with the question, but
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But the question may be bogus, because of where the messenger has been bogus a lot of times before (laugh) [48]
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1:11:04
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the idea, the best, well, the best, well in that case the best response is “I don’t know”
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Well I’m just gonna say what I think about Chapman because he’s proven himself, many times to be questionable

I don’t see him on my blog responding to my criticism [7]
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There’s something that that we don’t know, you’re coming, honestly we didn’t know what to expect when we talked to you

We, were looking at the design, of your web-site and wondering whether or not we would be able to get a a coherent sentence out of you, because the web-site is disorganized, uh

Um, at at at at least it’s the organization is not apparent to the readers

Um, and um according to
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That’s like, that’s like saying that Gorski’s web-site is disorganized, his blog is like anti vaccine one day, Burzynski the next, blah blah blah
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No, that is tied together
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1:12:00
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(laughing)
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But let me, we know that that the the, the central concern is Burzynski

Ah, the source of this ah of of those #’s that I just gave you, Chapman has just updated me and he says um that it is, and I’ll go back to the, the ADR research . com issues in clinical research, so it’s the question, Bay Clinical uh Research and Clinical Development,a white paper called “Why do so many phase 3 clinical trials fail ?”

Uh, it’s prepared by Anistazios Retzios, Ph.D

Is Anistazios Retzios r