Pete Cohen chats with Dr. Stanislaw Burzynski – Interview #2

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Dr. B interview #2
2/7/2013 (10:31)
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Why do you continue to do this ?
Why haven’t you just, given up ?

Because I am right
Why should I stop when I have 100’s of people who are cured

Mhmm

from incurable brain tumors
Ok
We have over 100 people, who are surviving over 5 years, just in the supervised clinical trials with brain tumors
So obviously this works (laughing)
It works in great way
So why should I stop because, some evil people like me to stop ?
It doesn’t make any sense
Evil will lose
So we are right, and we’re going to win
Not, uh, no matter how soon this will be established, but we are going to win

Well, for what it’s worth, and this is something, this is why I wanted to put myself, uh, in front of the camera with you
Obviously I spent 8 months, um, and I’ll try and not get too emotional about it, because that’s unprofessional (laughs)

Yes

but I spent, I spent a long time, looking into this, speaking to people,

Yes

You have very kindly given me access to everything here

Sure

Speak to anyone
Speak to patients
To see medical records, and I have, uh, been amazed by what I, what I’ve seen
I know the statistics are now showing, in the world, that one in two men, will have cancer
One in 3 women, will have cancer

Yes

It’s a, it’s a massive problem

That’s right

And I can see that you’ve genuinely found, uh, a cure for cancer

(?)

You know, it might not work for everyone, but if you’re given the su

Yeah

given the support

Yes

If you’re given, uh, the, uh, I don’t know, just the support basically, and the funds maybe, you could really, do some work, that could change, the whole (nature ?)

Absolutely, and then we can get better, and better
Of course, what you have now is not yet the finished products
We understand that
That’s something we can substantially improve
The response rate can be improved
So, certainly, all of this can be done, but, obviously, we need the resources
We need time to do it, and most of my time is spent with such silly thing like, uh, uh, protecting ourselves against attacks from, the people who are hired to destroy us
Ok
Obviously, there are some companies who are working on the payroll of pharmaceutical business, who are trying to smear us
To spread bad publicity about us
To generate lies about us
These people are criminals, and they are still flourishing
The end for them will come soon, but they are still hurting the other people
because the other people will not take treatment
They will not come, and they will die
Ok
There is no cure for, uh, uh, malignant brain tumors which are inoperable, ok, and we can cure at least, good percent of these people
We presented, our results, at many, many, 1st class
scientific congresses, like nuero-oncology congresses, cancer congresses, and it’s important for U.K.
I showed you yesterday, eh, presentation on brainstem glioma in children

Yeah, I have it here

and at the same, uh, Congress, in Edinburgh, we presented also another, eh, eh, paper, on the treatment of glioblastoma multiforme, and the survival on, about 88 patients, in glioblastoma multiforme
So obviously, I make, I make this available to everybody , they would like to listen, come to my presentation
They, they, they know about it, but they don’t want to know about it

Why not ?

(laughs) Because they are working
They are slaves of the big pharmaceutical cartels, ok, and on the payroll of big companies
They hate to see somebody else outside, the slavery, who can do it
I’m free man
I can, ah, do the research because, I am spending my own money for it
I don’t need to beg pharmaceutical companies or government to give me the money
I can do it on my own
They hate it
These people
They hate it because they have slave mentality

Mmm

They arch their back for scraps of money from the table, of some powerful companies, from the government, and they, how can you deal with s, slaves
They don’t want to see something new because this would disrupt, slavery system
Ok
So, current medical education s, system is manufacturing robots
They don’t think on their own, they use only what, the government, or the lawyers of the government, or what the administrators will tell them to do, ok, and if they don’t then they get punished, ok (laughs), and that’s a great system for a ph, pharmaceutical companies, because obviously they can make a lot of money, but it’s not a great system for people who have cancer because they don’t have good results

So you’ve presented at these conferences, and people don’t come up to you afterwards and say:

Mhmm

“I want to come and see what you’re doing
I’ve got to see this for myself”

Ah, well, uh, at each of these Congresses I meet a few doctors who are top specialists in their area who will come to me and say: “Ok, this looks very interesting
We’d like to know more about it
Please send me some, eh, results and a few cases that I can review,”
and that’s what you do

Yeah

You send them these cases, and that’s the end of it
I don’t hear from them anymore because they’re afraid to move any

Mmm

further, ok, because they know if they move further, they get punished
They don’t receive grants
They’d be scrutinized by their peers
They’re afraid
Ok (laughs)

Yeah

They work for us

Yeah

they work for us undercover
We have over 100 telephone callers who used to work with us, but they don’t want anybody to know about it because they’d be immediately attacked by the other guys

And the pharmaceutical world as well

Ah, well, the other guys are obviously working for cartels
Uh, they’re on the payroll, a, oh, of big business, which is cancer business, and they don’t want to lose it
Uh, in average, uh, city you might have say about 20 oncologists
One of them may work for us, but he does not no, want to tell anybody that he’s doing this because he would be destroyed by the other guys
These 20 guys will jump on him and he will, won’t have practice anymore
Ok

Yeah

So that’s, uh, the travesty, but, uh, uh, I believe that this is coming to the end
Ultimately, su, more and more doctors will learn what we do

Yeah

and more and more patients will benefit, and the breakthrough will come, but before the breakthrough will come, you have the toughest time

Mmm

because, the opposition is mounting the attacks
Whenever we came up with an announcement that was in the 20th century, we have such and such success, you are furiously attacked by the other guys, who are on payroll, uh, of cartels
Ok (laughs), for no apparent reason
You should be congratulated but we are attacked, because they see we are going to win, and they hate to see this because this means they won’t see money anymore for them, ok, or at least they think they won’t, they won’t have their payroll anymore
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Dr. Burzynski on publishing (6:18)
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So why does, why does, ev, everyone hide behind this thing of saying about publishing, because that’s the thing you hear all the time

Well, we cannot publish until the time is right (laughs)

Yeah

If you would like to publish the results of, of a
10 year survival, for instance

Mmm

Which we have
Nobody has over 10 year survival in
malignant brain tumor, but we do, and if you like to do it right, it takes time to prepare it, and that’s what we do now
What we publish so far
We publish numerous, uh, publications which were, interim reports when we are still continuing clinical trials
Now we are preparing, a number of publications for final reports
Eh, many of my publications were rejected by known publi, by known journals like

Why ?

like Lancet, like JAMA,
like New England Journal of Medicine
Why ?
Because they say: “Sorry, but you didn’t receive enough priority to be published, and if you look in these journals and 1/2 of the, these journals, they are advertising for pharmaceutical companies
Obviously if this would come from a pharmaceutical company, this would be published on the 1st page

Mhmm

Ok
Because this, you don’t have objectivity with these guys
They are on the payrolls of the big cartels, ok, and again and if you try again to send, oh, oh, my manuscript to good journals, if they reject it, we go on Internet and you describe what are these guys
So then everybody will know, because I have very good evidence
that we tried many times to publish in 1st class journals, and we are always rejected

It’s just, persistent

And not, and not because of lack of scientific knowledge
No, because of lack of priority
And who has priority ?
The guys who are paying money for advertising
Ok
So that’s, unfortunately what I think will end sometime
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And we are now preparing publication, on some of these results
We have already published the results on the technique of very difficult variety of breast cancer, which is triple-negative breast cancer
Now we are preparing another article on the technique of
gynecological cancer, which is best series of over 100 patients treated with incurable ovarian cancer, uterine cancer, (?)
So this, has now been prepared for press
Eh, of course, I would like to, give everybody intravenous antineoplastonssee, if they qualified, but, this is limited by the government, because the government limits us to only the patients who are
have
brain tumors, but the other patients, they can be treated through this combination of medication which work on the genes
Antineoplastonswork on over 100 different genes
That’s why they give us, very good advantage
There are medications that also work on a number of different genes, and we can combine them together, and use them in the right way
So
that’s what we’ll continue to perfect, and that’s, uh, most of our patients
been treated with just combination of targeted medications
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The Future (9:00)
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Why do you continue to do this ?
Because you know the truth, and you want to get the truth out there ?

Absolutely, because we understand we on the right track
Somebody has to do it
I was lucky enough to, find out about it
We have evidence that we are right, and, uh, I don’t think, why should I stop if, people that don’t have sufficient knowledge, who are working, on behalf of some big business, would like to stop us
We are right, and we would like to continue to help people, and, uh, that is what is going to happen
Of course, probably the best reason to make a discovery, and let it stay as it is and ask the other people to publish after I die

Yeah

That’s what happened with the discovery of Nicolaus Copernicus, who was my countryman
Eh, his book was published, sss, when he died, and, uh, for good reason, because of such fears for execution of the people who followed him
like

Hmmm

Galileo, Giordano Bruno, that it took the church, uh, only until recently to agree that, uh, they made the error, in the case
Ok
So if you come up with some breakthrough, you have a choice
Keep it quite until the other guys who understand what you do
or try to use it
In my case, I decided to use it, because I would like to, help people, and now that we can save people, so why should I keep quiet, ok, but certainly if, my work won’t get published because it keeps getting rejected by some of the journals, then we wait until I die, and then we let the other guys publish it
So, ok
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Pete Cohen chats with Dr. Juan F. Martinez-Canca, Neurosurgeon (Consultant) about Hannah Bradley

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Juan F. Martinez-Canca – Consultant – Neurosurgeon
(20:31)
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So tell me a little about brain tumors

When did you kind of first come across your first brain tumor ?

My very first brain tumor was in high school, unknown entity, fascinating, enigmatic

Unknown, is the word

Uh yes, I hoped

I must say the uh vocation initially in my case came at an early stage in my life

I remember very well, 3 years old saying I will be a doctor, a doctor, a doctor, and gradually I became aware of this vocation from neurosurgery but really I didn’t know what from because of vocations like see it
I put in my soul, so what ?
Here we are

vocation
realize that in the following years
My first professional brain tumor was impressed in 1996, something called glioblastoma multiforme, and I was uh, uh, shocked, and thrilled, and excited by seeing a nasty glioma as my register described it

And I was uh in as you can see my poor English
I just wrote in my notebook nasty glioma must be nasty in the history of classification

That person died, unfortunately after a few months, it was a very bad disease, at that stage, was really advanced and uh that was my first ? with reality
The glioblastoma, or nasty gliomas kill people
And that was the starting point of a, of a very complex process that I am still never looking (?)
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Hannah’s Operation (1:35)
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In the case of Hannah we wanted to wake her up to make sure that we could remove the whole entire ter (?) as much as we can see, or feel it, without damaging, basic structures

Language, relation with outside world, movement, etcetera, etcetera

That requires a very specific and very expert high expertise from the, from the surgeon, because normally everyone is not awake during this
It’s a very specific operation

Mr ? we were lucky, was there to do it, and I was lucky enough to be the co-pilot

So we performed this procedure
I can’t remember the date now

April, the 1st

April
Correct
Good date
So

April Fools Day

On April the 1st we awakened ?
and I remember very well, that huge feeling of satisfaction, at the end of the procedure

I have, I still have my pictures, do you remember ?

We were taking some pictures during the operation
and that is ? like a trophy, because some people are not very good, some of the people are not very well, but in this case we had fantastic surgeon, a fantastic patient, and a great environment, and it worked very well
And the end of the operation, I remember seeing Hannah’s brain without physical tumor, microscopic means with the eyes
Of course, millions and millions of cells still widespread in the brain
A tumor is never a circumscribed entity
It goes all over the place
Nevertheless, it was a very satisfactory physical procedure
We send the samples for histological purposes
and unfortunately we were wrong, because it was not a grade 2, not a grade 1, it was a grade 3 tumor
? the next step
The grading of the tumors
When grade 1’s and 2’s, usually consider the good guys in the field
But not a good thing to have a brain tumor, but you have to choose, choose a grade 1, or a grade 2
Grades 3 and 4 featured by malignancy
By aggressiveness
They are far more active tumors than the 1’s and 2’s
Maybe the grow much bigger, and they are far more aggressive than the other 2
Specially grade 4
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(3:42)
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So you got out most of it, yeah ?

Yeah, it was fun but got a good job here because you’ve got most of the tumor out, and we have Hannah talking, moving, and uh conversing normally
She was no percentage (?) deficit
At some point during the operation she had some stuff, a fitting, some sort of vagueness and she couldn’t talk very well, so we had to stop right away, and change the level of, of oxygenation, but other the operation, microscopically speaking, the whole tumor was taken away

So the tumor was taken away, so it was a success, but in the back of your mind did you know that, did, the job was not complete ?

We always know
We always know that
Except when we are talking with a benign meningeal (?) grade 1 that we can take physically lump away
Except in those cases of rare, rare success and joy
Most of the tumors we know, have millions of cells that remain in the brain, and they can be very, very aggressive

So, did you know in the back of your mind that what you were really doing, in this case, was probably just prolonging her life ?

Uh, in a way we are providing a setting, for a 2nd stage therapy to take place
Certainly, if we do nothing about it in the large (?), which is a (?) part of her brain, Hannah had little chance to survive, many weeks from now
Once the whole thing developed, we knew it was a count down
We need to do 2 things, to establish a way to help her to prolong her life with best programs
That’s, is a universally accepted
Removing a tumor is no longer an option
Again, I believe that (camcorder ?)

Yeah

So Hannah had radiotherapy, and you saw the scans after the radiotherapy, and, and what did you see ?

Ok
We decided, no Hannah decided to go through conventional pathways of treating of tumors, which is oncology medicine (?)
She had radiotherapy, which aim is to kill the remaining cells we have not been able to remove, remove in surgery

So, that happens, and Hannah had a shrinking stage of uh of things, with subsequent scans show the suc success
It was not much tumor
However, the remaining amount of cells were there from day one
We knew they existed, and they were visible on the scan
We could actually produce the scans later right ?

Yeah

And I will show you pictures of Hannah
And we knew there was (reserve ?) tumor
The aim of the radiotherapy was to try and kill these remnants of tumor that have remained behind
In her case, it was not much tumor left, because we know that subsequent scans were done following radiotherapy
Still the small areas of tumor highlighting halo were still here, as you, as a (?), as a reminder, of the main tumor

Inevitably those cells would progress again, to a further tumor, and usually, to a high grade tumor where the tumor progressed, normally is not rare, to see that they, scale one grade
So, the fear here with Hannah was get, this grade 3, would progress to grade 4 at some point
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Dr. Martinez on Dr. Burzynski (6:50)
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Quite obviously you knew that I did a lot of investigating

I looked for people in the world who were still alive, who had uh, this type of tumor

I spoke to you

You told me, of, some things uh, and I’d mentioned to you Dr. Burzynski

What did you

What did you think about that when I 1st mentioned it to you ?

Well, when you mentioned that to me I didn’t know Dr. Burzynski at all

I knew there were some people going to Houston for some therapy, among them, one well known Spanish singer, but she’s well known, very well known actually, going from a, from a another kind of tumor, not a, not a brain tumor
But I knew vaguely about this a, this a person in, in Texas, with his uh fancy treatment, challenging establishment, but, as I said, a little
amount of, of knowledge in my brain
in my brain
Well, I knew immediately when you mentioned that, as well as other options that we discussed, I looked at every option you’ve showed me, because you were really active in looking and intimate, in the literature
You gave me 2 or 3 main leads of reading, but certainly Burzynski came as the most solid one, because the rest of them you gave me were really experimental therapies, with little or no success, and uh more in my dimension but more imagination than technique, with them
So, I look at Burzynski’s story, and was almost immediately moved about, about his personal uh yearning
Is a person who has been, how many years now ?
20+ ?

30

30+, sorry, fighting against the very powerful medical establishment, and subjected to court judgments, to punishment by a, by a (?) community, to intense scrutiny, and uh, ostracized by the so-called uh conventional doctors
Despite that, 30 years + later, still doing his business, in fact, the most important thing, with a huge amount of people, smiling, alive, and very healthy following the diagnosis of the tumor
To me that was something revealing
No matter whether this man advocates, on praying to the moon, or going to the sea, (whatever it is ?)
The fact is the fact
He has a large # of patients, alive and well, following diagnosis of tumor
In fact, the most important, children, at the age of 3 or 4, being treated by this uh therapy, reaching 30’s, reaching 20’s, and alive, and very nice, this a living example, that this man, is not uh, selling air
Ok
For that I went to the films, available to everyone on the Internet, on YouTube, except the usual terms of communication
I dislike very much, they commit (?)
I really dislike it
But, I must admit it was a good way, to put the facts to the public
This way
The main criticism of Burzynski in the scientific community, is the lack of reliable communications
That, that’s a fact
I will not go into this during this interview, this chat

Yeah

Ok
Because I think it’s a matter for, further discussion
I only go to the physical facts that you can see
In the last court proceedings, there were a large # of supporters, saying, we are the living example, of this process isn’t pantomime (?)
Well I think in my humble microscopical opinion, Burzyn, Burzynski’s trying to do, is to show another way to treat cancer

Another way which directs completely from the current guidelines
The current guidelines are full of financial interests, are full of international agreements, and of course someone who attempts to upset this structure will face serious adversity
This man is brave enough to put his person, his family, his world, on the spot, to fight for the truth
To me, it’s clear
This guy, not going into details again, I don’t want to go into technical details today, because something for further discussion, but only the facts he’s presented, is strong enough to stop and think about it
That’s why, I would like to say, in the 1st instance

And obviously you’ve seen Hannah’s su, scans, and you saw her last scan, and you can see uh her

Well since you told me about this, I intense look at the Internet again, all the available evidence, I looked at his, uh, not publications but at his data
I, I have no peer-review qualifications yet, about Burzynski’s cases, but I look at practical cases
Too many, to be a random chance of, oh this is, she has a one in a million
No, it has, many ones in a million to be a chance
So this man is presenting something serious
So, I ask (?) (?)
Forced to do, because, I thought, ok, what you face here is a conventional radiotherapy, chemotherapy, but if you look at the #’s, that is again, in the public domain, people with grade 3’s, will not survive longer
Grade 4’s, do not survive longer
My duty as doctor is to tell the patient, the person with the grade 4 tumor, you have about 11 months to live without treatment
Be lucky
With treatment is unpredictable
(I don’t know ? or all along ?)
But the #’s are #’s
If you look at the data, people die very quickly from a grade 4
Grade 3, follows very closely
So I thought, there’s nothing to lose by this therapy, because #1 is not incompatible wha, with what you have been doing so far, and it gives you a chance to change perspective, to change environment
Go to a different setting, and try it
That’s a fact (?)
Plus the fact that many, many, many people are being treated (?)
under this guidance, and they are surviving very well, and they are alive

Mmm

Hannah’s case
When are you going to Texas ?

We went in December

December
Well you come back just a few days ago

We came back 3 weeks ago in January

So in that period Hannah had her tumor treated with antineoplastons, and there has already been a scan, which shows shrinking of 15%

Yeah

Is such a long, long journey, you have a nice little period, a month and a 1/2 maybe ?

Yeah

After so many months of punishment and suffering, and which have a nice (result ?)
Plus, the emotion of Hannah
Hannah has come back to normal, I think
I remember her very depressed and the beginning of story, and not having any single hope in her mind
I remember a video where she was crying
Now she has this chuckle in the video when she is joking about the scan, and so positive and optimistic, and the results cannot be more promising
That, in my view, (certain was seen ?) in detail, I think
——————————————————————
Hannah’s MRI scans (13:34)
——————————————————————
Take a look at this
This area of bright, intensity here, is not in the right, so poorly, is abnormal
And that was the 1st pictures we saw for Hannah
And some people said, that must be a stroke because of this a straight line there, and there
Normally, as a rule of thumb, something with a wedge shape, tends to be a stroke, because the vessel, providing blood, opens in the small vessels in a wedge fashion
It look a stroke to me actually, to, to be, to be honest, the very fact that we thought it was a stroke, but then we came to recognize it was a tumor, for all the features in (?)
So this is the 1st picture
If we look at the, on the side of the screen, we have now a different view
Instead of looking from the feet, we’re looking at front of Hannah
Eyes are here
That’s the brain
Left side
Right side
Look at the left side, because we know, the tumor’s (?) on the left
We look to go, deeper in her head, and we see, a dark area
It’s a different fashion (?) and that’s why you can see the white, becomes like a black
And you can see, the edges of this is strange, formation
Clearly abnormal because nothing there in the side
So this, was the question for the individual
What is it ?
So after a little bit of discussion we came to the conclusion that thought it was a glioma, tumor, from description, in the brain
So

This is after the operation

After the operation

Operation

This is the 17th through the 4th

Yep
We go on the right side better because this is the film
We see here something very clear
I want to get another view, so you understand a little bit better
Yeah, this
In this view, you can see
Can you see that ?

Yep

You can see the (?)
The chunk of bone, we take away, to go into the brain
And these are screws and plates, to keep things in place
2 screws, one little plate
And there, the other one
Ok ?
So this is the axis
Let’s put it on the right so you can see it better
Here, you can see it much better how the craniotomy is performed with one hole, one drill, to put the, the saw and drill away, and you can lift this cover
Ok ?
At the end of the operation we put this plates, one there, one there, one there, and one there, as you can see
2 little plates
2 little screws with one plate to fix the hole
Ok ?
And then, the skin itself
——————————————————————
The Future for the Treatment of Cancer (16:18)
——————————————————————
So, so how do you think uh brain tumors will be treated in the future ?

That’s a, that’s a very good question
Uh, certainly not this way
Let me give an answer for another time
But certainly not this way, because uh the chemotherapy, the main, the main group of chemotherapy is that, it is itself a killing agent
You are using, destructive element, to try and prolong life
In, in itself makes no sense to me
Of course, the, the argument for that from the, from the (chemical ?) companies, from the people who produce this (?), excuse me, this doctor, we are saving lives, and it’s true
This is the only way, officially admitted today, to treat tumors, chemotherapy

So do you think we’ll have a cure for cancer ?

I’m hope it is
I think it’s coming, actually, but uh, but uh, it’s not accepted

Then you think Dr. Burzynski’s really on to something ?

Definitely
The evidence is overwhelming
He’s not I think, the evidence
What I think is irrelevant
Oh my opinion is one opinion in, in millions of them
But if you look at the facts, Dr. Burzynski is achieving things
It’s not, it’s not promising
Is it
It’s the delivery of things
If, if I don’t understand it incorrectly
The head of our patients, he’s an ex-patient of cancer
Am I right ?
This girl had a brain tumor
Hannah was talking to people have been cured
So this is a fact
This is not tales
This is not uh, uh, selling, thin air
This man, whatever he’s doing, because of his story
Part of his secret agenda, the
chemicals (?)
be explained
I not asking for the patent of his things
I don’t, I don’t care anyway
But he’s working with compounds, with substances created by this man, that cure people

So why do you think more people aren’t receptive, to the, you know, other oncologists, neurosurgeons ?

That’s a very complex question because uh we are fighting against a very well established protocol of producing doctors that think in a very particular way
Who, whoever decides to direct from that way of thinking is in hot water
Invariably
The scientific community these days, is uh biased by peer-reviewed publications, commonly accepted guidelines, and there’s no space whatsoever, for any, eh, diversion from the norm
Put it this way
Ok
I’m not saying that I directed (?) from norm
I’m not here to argue the system, but I am here, to ask questions
I would like to ask questions
Why, we have to accept
I was in medical school, and I was told by a pediatrician, (?) of the (?) service, babies should a stop breast feeding at the month #4, and they start with these magic formulas for babies
At that, at that point I believed
At that point I was a very young medical student
I said, (?) the head of pediatricians tell me, my baby has to stop breast feeding, at the age of 4 months, must be true
He is a doctor, but he’s a stupid (doc ?
I am so sorry to disagree
He was delivering, a very nasty message
Basically you should continue, 2 years away, 3 years away, when the baby says, that’s it
Naturally stop the breast feeding
You understand what I mean ?
So, in the same fashion, the oncologist delivers the message that they have been taught, by the teachers
And then you go up in the scale
Ok
If you go up in the pyramid, the top of the pyramid is usually money, eh, economic interests, political interests, namely
We go outside the core mains of medicine
That’s why my complaint
That’s why my fight here
I would like to ask those things
I may be wrong, by at the end of the day
I may be
I don’t know
I don’t know all the answers
But if at the end of very good search, I am convinced that this is the only way, I say, I am sorry
I had to ask
Go back to the norm
But (?)
I totally suspect that the norm is wrong
There must be another way
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http://www.neurokonsilia.com/About-Us.html
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United States Food and Drug Administration (FDA): September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51

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[1] – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
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BB – Bob Blaskiewicz
——————————————————————
DJT – Didymus Judas Thomas
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0:47:00
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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”
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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
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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
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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
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https://stanislawrajmundburzynski.wordpress.com/2013/10/04/september-28-2013-the-skeptics-burzynski-discussion-by-bob-blaskiewicz-21951/
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[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/
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[3] – The Skeptics @Majikthyse reveals madjik research skilz:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/26/the-skeptics-majikthyse-reveals-madjik-research-skilz/
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[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/
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[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/
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[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/
======================================

[8] – 1993 (10/26/1993) – Burzynski to Dr. Michael A. Friedman

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
======================================
[8] – 1993 (10/26/1993) – Burzynski to Dr. Michael A. Friedman
——————————————————————
Dear Dr. Friedman,

In response to your letter of 10/20/1993, it is difficult for me to understand why the entire 1st page of your letter is used to discuss the simplest issue:

that adults should use a different dosage than that used for children

Since you agreed to the study procedure of Protocol BT-6 as recommended in my letter of 6/9/1993, we have not requested any changes in the structure of treatment which was accepted by Memorial-Sloan-Kettering Cancer Center (MSKCC)

As you confirmed in your letter of 10/20/1993, you know very well that since 4/1/1993 of this year my recommended dosage of Antineoplaston AS2-1 for adults is 0.4g/kg/24h

Again, I confirmed that this is the right dosage for adults in my letter to Dr. Shoemaker of 8/24/1993

Yet, for no apparent reason, you insist on using in the adult treatment protocol the dosage 0.6g/kg/24h which I recommend for children

It is generally known that a child’s body weight is much lower than that of adults

This should be reflected in the escalation of the dosages

My recommendation as to how to escalate the dosages for adults was submitted to the NCI on 6/4/1992

Yet, for no apparent reason the MSKCC protocol, which is designed for adults, escalates the dosages in the small increments recommended for children

The principle behind dose escalation is to accomplish the maximum dosage in 3 to 5 days, not 3 to 4 weeks, which would expose the patient to the unnecessary risk of tumor progression

I appreciate very much that you have finally decided to follow my recommendation regarding dosage and dosage escalation

Regarding the number of patients to be treated at MSKCC, the contradictory, incomplete, and inconsistent information is being supplied by you

The MSKCC’s protocol of 4/16/1993, 7/13/1993, and 8/30/1993 describe the treatment of 35,

Pg. 2

but not 70 patients

(please see paragraph 12.1, pg. 10 of the protocol, which is attached)

It was our understanding that 35 patients would be treated at MSKCC and at the Mayo Clinic

I never agreed for the treatment of 70 patients at MSKCC

Since I have to produce the medicine for the trial and pay for it, it is vitally important to me to know how many patients will be treated

The treatment of an additional 35 patients may cost up to 2 million dollars

Contrary to the information given by NCI that we received the money for the production of medicine, this money went apparently into a “black hole”

(“Black Holism,” The Village Voice, 7/29/1993, enclosed)

We have received none of the money which the Office of Alternative Medicine gave to the NCI for funding the trials with our medicine

Contrary to the opinion expressed in your letter, we see no reason for modifying Fleming’s Phase II clinical trial design and introducing more stringent than usual criteria for response evaluation

We request that Fleming’s original design be used, which calls for the initial treatment of 15 patients with at least one responder, instead of 20 patients and 2 responders

Given the fact that there is no existing treatment effective in this type of cancer, one responder in 15 is certainly significant and would be reason enough to expand the trial

I found your your requirement for 14 days to complete scans and laboratory tests prior to treatment very interesting

It is a very well known fact that glioblastoma multiforme is such an active tumor that if 2 weeks elapses from the time of the scan and the beginning of treatment, the tumor may increase by more than 50%

This means that even before the patient begins treatment, he can be classified as an increasing disease case

In most of the hospitals in the U.S., including out tiny clinic, all pretreatment tests including the scans can be done in one day

Therefore, I insist that the pretreatment evaluation, including brain scans, be done within 7 days from the time treatment begins

Regarding the Karnofsky Performance Status (PS), it is unclear to me why you have backed off from your own recommendation in your letter of 5/5/1993 (copy attached) that “patients with Karnofsky PS of below 70% should be excluded”

I am requesting that as recommended by NCI, the patient’s PS should be 70% to 100%

I agree that both scan data and neurological assessment can be described in the analysis of response, but the decision of how to classify response should be based on tumor measurements alone

All of these patients will have been extensively treated before

As the result of previous neurotoxic treatments, a number of these patients will deteriorate neurologically even if the Antineoplastons eradicate the

Pg. 3

tumor

The purpose of the protocol is to evaluate the antitumor effect, not to prove that Antineoplastons can repair brain damage resulting from chemotherapy and radiation

In this 1st independent study with Antineoplastons, in order to assure that patients will derive the most benefit from the treatment, it is critically important to schedule more frequent evaluations of the data than waiting until after the accrual of 14 patients, i.e. waiting 9 months

(Based on an accrual of 2 patients per month, if we wait until 14 patients are accrued and treated, 9 months will pass before the 1st evaluation takes place)

Therefore, I request that reviews of the studies be performed after the treatment of each group of 5 patients, i.e. after 6 months

I agree, however, that you will provide the Theradex printout to us as you receive it

In addition to patient welfare, there is another reason for more frequent patient evaluations

As you stated in your letter, I have no doubt that the investigators at MSKCC have extensive experience treating glioma

However, MSKCC is known to be biased against Antineoplastons

At least 3 researchers associated with MSKCC published willful misrepresentations and distortions about Antineoplaston research

Because of the controversial nature of the upcoming Antineoplaston clinical trials, it is essential that they are conducted in a manner beyond any suspicion of bias

Contrary to the opinion expressed in your letter, NCI is responsible for the trial’s delay

As you well know, the NCI selected an MSKCC investigator in 9/1992

In spite of our repeated requests, 8 months were waisted before the NCI produced the 1st draft of the protocol

As promised in my letter to you of 11/11/1992, the supply of Antineoplastons has been prepared and was shown to Ms. Mary McCabe of NCI during the site visit on 2/9/1993

The medicine was ready to be released pending final approval approval of the labels by the FDA and our final QC inspection

The medicine will be sent to you immediately once you make the corrections to the protocol that we have requested

Since you mentioned that patient recruitment has begun already, I would be glad to accept these patients immediately under my care and offer them free medicine as we wait for the protocol to be revised and the treatment at MSKCC to begin

The MSKCC protocol in its current form would threaten the welfare of these patients

In your letter you stated that your mission is to find and develop better therapies for cancer patients, and that your only obligation is to those patients

However, the way

Pg. 4

you proceed leads me to question that for the following reasons:

1) Out of numerous cancer treatment centers, you selected 2:

MSKCC and Mayo Clinic, which are known to be strongly biased against alternative treatments

In the past doctors associated with MSKCC have voiced strong opposition to Antineoplaston therapy and have published articles full of misrepresentations and distortions

2) The protocol approved by you will allow the disease to progress between the pretreatment evaluation and the beginning of treatment

3) Due to the slow escalation of dosages, patients will most likely have marked increase of tumor size beginning the treatment at the correct dosage level

4) In spite of my numerous requests (letters of 4/29/1993, 6/9/1993, and 8/24/1993) to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991 to have a separate clinical trial for glioblastoma multiforme and anaplastic astrocytoma, you continue to combine both types of tumors together

Even in your most recent stratification strategy submitted to the FDA, you are planning to treat initially 20 patients without specifying whether those 20 patients are per each stratum (glioblastoma vs. anaplastic astrocytoma), or whether this initial group of 20 patients consist of a mixture of glioblastoma and anaplastic astrocytoma

If the latter is the case, then we can expect that among these 1st 20 patients, most will have glioblastoma, which is more common and more difficult to treat

In case of treatment failure in these 20 patients, it will be easy to make the statement that Antineoplastons do not have therapeutic effect in both tumor categories

5) The protocol now states in paragraph 10.2, 10.3, and 10.4 that the objective decrease of tumor size is not enough to be considered a true response to treatment, that there must also be improvement in neurological function

As I explained in my letter of 10/13/1993 to Dr. Greenblatt, it is not unusual in my practice to see patients whose tumor has disappeared, but who have deteriorated neurologically as the result of delayed toxicity from radiation therapy and chemotherapy

Since these patients in the MSKCC study have been pretreated, and since there has been no indication that anything, including Antineoplastons, can repair brain damage caused by chemotherapy and radiation, I request that the criteria including restored neurological functioning be removed from paragraphs 10.2, 10.3, and 10.4 of the protocol

Pg, 5

6) Finally, by limiting our access to the data and not allowing review until after the 1st 14 patients have been treated, it would be easy to deviate from the protocol and supply inadequate treatment, and then claim that due to the the failure of the 1st 14 patients it would be a waste of the taxpayers money to proceed with further treatment

Your final statements that you are ready to proceed with the treatment with Antineoplastons without our participation caught me by surprise

It is hard to imagine that a Federal employee would consider patent infringement, thus infringing on the patent rights of thousands of our shareholders

Once again, I urge you to take our requests seriously, honor the guidelines of the NCI’s Decision Network on 12/2/1991, and make proper corrections to the protocol, so that objective clinical studies can begin immediately

In the meantime, I would be glad to treat for free all the patients presently recruited, and will submit progress reports weekly for the NCI’s review and evaluation

SRB/cf

cc:

Senator Joseph Biden
Senator Barbara Boxer
Senator Dianne Feinstein
Senator Tom Harkin
Senator Barbara Mikulski
Congressman Berkley Bedell
Congresswoman Nancy Pelosi
Dr. Samuel Broder
Dr. Jan Buckner
Dr. Bruce Chabner
Dr. Daniel Eskinazi
Dr. Jay Greenblatt
Dr. Joseph Jacobs
Dr. Mark Malkin
Ms. Mary McCabe
Dr. David Parkinson
Dr. Mario Sznol
Ms. Dorothy Tisevich
======================================

======================================
1993 (10/26/1993) – SRB to [5]
1993 (10/26/1993) – SRB to [14]
1991 (12/2/1991) – guidelines of the NCI’s Decision Network [5 Pgs.]
1992 (6/4/1992) Burzynski to NCI
1992 (9/1992) – NCI selected MSKCC investigator
1992 (11/11/1992) – Burzynski to Dr. Michael A. Friedman
1993 (2/9/1993) – NCI Mary McCabe site visit
1993 (4/1/1993) –
1993 (4/16/1993) – MSKCC protocol
1993 (4/29/1993) – Burzynski to
to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991
1993 (5/5/1993) – Dr. Michael A. Friedman to Burzynski
1993 (6/9/1993) – Burzynski to
to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991
1993 (7/13/1993) – MSKCC protocol
1993 (7/29/1993) – “Black Holism,” The Village Voice
1993 (8/24/1993) – Burzynski to Dr. Dale Shoemaker
to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991
1993 (8/30/1993) – MSKCC protocol
1993 (10/20/1993) – Dr. Michael A. Friedman to Burzynski
======================================

[1] – 1991 (10/4/1991) – Site visit – Antineoplaston Cases

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
======================================
[1] – 1991 (10/4/1991) – Site visit – Antineoplaston Cases (1 pg.)
——————————————————————
1. Histology partial lobe glioblastoma multiforme (GBM)
Size 2.3 cm largest diameter
Response Complete Response (CR) possible
prior Treatment (Tx) Radiation Therapy (RT), surgery

2. Histology anaplastic astrocytoma stage IV grade 3
Size 3.0 tumor 3.5 tumor and edema
Response CR possible
prior Treatment (Tx) Radiation Therapy (RT)

3. Histology infiltrating glioma (astrocytoma or mixed astrocytoma / oligodendroglioma)
Size 4.4
Response good PR, possible CR
prior Treatment (Tx) Radiation Therapy (RT) and BUdR; Procarbazine, CCNU, VCR; B-Interferon; DFMO and MGBG

4. Histology well differentiated Stage IV astrocytoma, possible juvenile pilocytic astrocytoma
Size 5.5 X 3.3
Response 40-50% decrease of solid component
prior Treatment (Tx) vitamins and laetrile

5. Histology glioblastoma multiforme (GBM)
Size 6.5 x 5.0
Response 39% decrease
prior Treatment (Tx) Radiation Therapy (RT)

6. Histology glioma consistent with anaplastic astrocytoma (AA), differential: anaplastic astrocytoma or spindle cell variant of oligodendroglioma
Size 5.1 x 2.2
Response Complete Response (CR)
prior Treatment (Tx) Radiation Therapy (RT)

7. Histology Infiltrating anaplastic astrocytoma (AA)
Size 4.0 (L) 4.8 (bifrontal)
Response good response – possible Complete Response (CR)
prior Treatment (Tx) Radiation Therapy (RT)

20130912-191141.jpg
======================================
1991 (10/4/1991) – site visit [3]
======================================

Robert J. (don’t call me “Bobby”) Blaskiewicz’s #Epic Skeptic “Word-Salad” #Fail – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51

Are you there ?
Okay, we might as well get started if were going to do this
Alright, so ummm I guess we can start with uhhh bit of a conversation
Uhhh
You’ve been on the Burzynski Hashtag for a long time – what’s you’re motivation ?
Okay
So what information have Skeptics posted that they uhhh that they missed that demonstrates that Burzynski’s uhhh treatments are effective ?
What, what have we missed ?
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
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
The the
Right
So, do you think that there is a uh uh conspiracy to keep Burzynski from publishing ?
Right
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
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
Alright, ah have you read The Other Burzynski Patient Group ?
So, ahmmm what is your response say to the story of Amelia Saunders ?
Okay, what part of, what did I get wrong ?
Uh was that Amelia and Luna ?
Luna was the other one, correct
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
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
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
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
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
Uhmmm, what part of that is not absolutely terrifying to you
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
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
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
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
He’s read everything
I think
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
That would be good
Uhmmm
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
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
What protections are in place for patients as far as that these kids are and and their parents are protected
Who had the better results ?
Okay
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
Ummm, do you have any sense of when these trials are going to be published ?
From Laura ?
Right
When you, when you think about a major, sorry, go ahead
Yeah, right, uh
Antineoplastons has a better rate ?
Right
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
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
But if you think about that, I mean that if it does have a a an improvement rate above uh other treatments
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
That’s a long time when someone is dying
Well, one of
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, 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
That’s not necessary for other deactsylace 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 ?
thats not necessary for other deactsylace inhibitors
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
ah he has asked everything that Burzynski does looks sort of like the behaviors of pseudo-science
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
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
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
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
Um, these are all huge red flags, that you’re dealing with a quack
Um, why hasn’t Burzynski done anything to change that ?
Right
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
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
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
Uhmmm
Well
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 ?
Right
You know, you know
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 ?
Well that’s just a known side-effect, your going to know that going in, but we actually have people say
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
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 ?
Are they feeding these people their stories ?
Are they feeding these people their stories
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
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
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
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
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
I, I just find that to be contradictory and and self-defeating
Um, let me see
Well, that’s not necessarily true
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
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
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
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
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
The exact same thing
Um, and that was a
Have you read Chase’s story
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, well 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
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 ?
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
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
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 deactsylace 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
This is the whole reason for going
And it has nothing to do with the with the with the drugs
Which is, which is like which we just pointed out was a was an invisible dragon
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
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
So you’re saying because the Orphan Drug Designation and the face that there’s a phase 3, therefor it works ?
So what you’re saying is there’s nothing that would convince you now, that 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
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
Um, I don’t know if you’ve read Jaffe’s book
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
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
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 ?
So, there there’s a lot to that
Um, uh, but yeah, let me go back to the Twitter feed
Um
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
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
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
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
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, 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
Do you think that that could possibly have anything to do with why we’re not seeing the phase 3 advance
He’s claimed
He’s claimed
That’s a different thing altogether
And in fact
Well, you understand why they do that, because in order to, it’s
No, they do do this with other drugs, well, it depends on the type
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 ?
Well, ok
It doesn’t matter where
It doesn’t matter where it comes from uh, um
So-kay, um that would be shooting the messenger as opposed to dealing with the question, but
the idea, the best, well, the best, well in that case the best response is “I don’t know”
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
No, that is tied together
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 pase 3 clinical trials fail ?
Uh, it’s prepared by Anastassios Retzios, Ph.D
Is Anastassios Retzios reliable ?
There is a correct here
Exactly
That’s the right answer
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
Um
What, what stuff would you like
What stuff would you like me to do ?
I generally, I don’t read your blog
Uh um, alright
Okay, I’ll look at that, and I will respond to it once I’ve taken a look at that, okay ?
Um, and I’ll respond on your web-site
Um, seems only fair
Um, one question I’d wondered, what is the Didymus Judas Thomas reference to
Oh, so this is the Doubting Thomas
This is the Doubting Thomas
Okay, so this is the one, you show me the, you put your your, the, your hand inside the wound
You know, Jesus says, basically, ok, bring it on, check me out, right ?
Okay
Alright
That that, I didn’t, I didn’t realize that he was also, that that was the same guy
So, it’s it’s the Doubting Thomas
Um, what we would say, um, is that if Burzynski is the savior that he claims to be, that he should, open up his trials, he should open up his uh research uh protocols um and just say, “Look, bring it on”
Check out these wounds
But he’s never done that
Instead he he he wants us to just take the words of of of of his apostles
I don’t necessarily trust his apostles
I don’t think that they’re unbiased
I wanna see the data
I wanna see the the wounds in his hands and the the mark on his side
Oh, hey when when we talk about The Other Burzynski Patient Group, I don’t make any pretensions to make that my site proves anything
I I I really don’t
It’s not my job to prove anything
It’s Burzynski’s job
It is a researchers job to prove these things
But we just pointed out, we just pointed out, that the FDA, often approves, phase 3 trials, based on flawed phase 2 clinical trials
That is therefor a real possibility in this case
Yes you would
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
But, um, uh but the way that you’d earlier phrased your uh your response to “could you possibly be proved wrong ?”, . . really did exclude other possibilities of of of of yourself being wrong
So if the FDA
Well I’m not talking about the Guy Chapman
What you off, when I asked you, yourself, you know, what would prove you wrong, you said that the FDA hasn’t approved a phase 3
Well, ok
Let’s let’s back, let’s back up
What would the FDA, what happens if the FDA occasionally op op opposes, approves uh phase 3 trials, based on bad phase 2 trials
Would that be, would that cause any doubt in your mind ?
About the efficacy of ANP
Yeah, hello, yeah, you’re back
Yeah Google+ is a little wonky sometimes
But, would, does, if you were to learn, that sometimes phase 3 trials, uh, are approved, and failed, based on flawed phase 2, would, would that make you reconsider your position of the phase 3 being evidence that it works
Uh um could you send me that link, the, the, um . me see
I’m just looking at other things that are coming in on the Hashtag right now
Um, so the ANP is Orphan Drug status but is it Orphan Drug for glioma ?
Is it sodium phenylbutyrate or is it the the versions of the drug, the AS10 stuff or A1 or whatever it’s called ?
Okay, that’s what has Orphan Drug status
Alright, I’ll look into that
I hope somebody is writing all this down out there, so that we can go back and look at these claims later, right ?
So, oh, um
Do you have any questions for me ?
I’ve spent a lot of times asking questions of you
Mhmm
Guy Chapman, throws up the the, the comment, permission to investigate is not evidence of anything other than evidence of a valid protocol, not a uh, evidence of efficacy, in and of itself
That’s another comment
Um, alright then, this is your chance t, there are lots of people have lots of questions about me out there
Uh, about what my motivations are and such
I might as well put that out on the table just so it’s on the record, is that I am taking exactly no money from anyone for this, and have gotten nothin’ but grief from a lot of people, even people who, even people who support me have given me grief for this
Um, just so that you know, um, there have been, some of the things that have happened, oh, this is an important point too
Um, that when we have criticized this, uh, a # of us, especially Gorski, uh myself, uh Rhys Morgan, uh, um, and and uh Popehat, the the lawyer, blog, uh, um, who else was on there, um, oh, the Merritts, uh, t, uh Wayne Merritt, and his family, people have been critical of of of Burzynski have faced retaliation for opposing him ah and intimidation, and including, um, I had my uh a couple weeks before Christmas my, my, the Chancellor of my University was contacted via e-mail, and uh Eric Merola said that I had been um, uh, been spreading mis truths about Burzynski, that I had been a be, on my my show um had said things that were demonstratively untrue, and he also said that the drug was FDA approved, which it, you know, that’s not right
But um, he said that he was gonna do, talk about me in his new movie, in, uh, relat, in millions of homes, um, and he wanted to get a statement from the University
The University of course ignored him, and immediately let me know that I was going to get smeared
Um, I consulted my lawyer and uh uh, you know, the best course of action was figured out, and um uh a Gorski has had his accreditation board contacted, he’s had his bosses contacted, Rhys Morgan received threats of liable suits from somebody who had been hired, by the clinic, to clean up his on-line reputation if he didn’t take down his on-line review of Burzynski, uh, had his a picture of his house sent to him, clearly the message being, “We know where you live kid,” uh, Wayne Merritt; a pancreatic cancer patient, this is something that, that people generally, do not recover from, like generally, die from, received phone calls at home, from, this individual, threatening him with lawsuits; he doesn’t have a law degree so he’s misrepresenting himself
Um, but all of this, was done, to critics
Do you think that is deserved ?
Do you think that that is right ?
Mhmm
Well to be fair
It it it doesn’t strike me as necessarily a “Free Speech” issue, you know
Was it down-voted ?
No
Mhmm
Mhmm
Well we do have for for for for one thing, um, I guess to understand is that we are uh motivated by um uh a respect, this is the one thing that that all Skeptics I think um are uh respect critical thinking, um, and um respect scientific uh a we we’re mostly scientific enthusiasts, there’s some Skeptics who are not um, uh, you know oh u space nerds, or whatever who are um just sc scholars and the humanities but for the most part we all respect scientific consensus and we respect scientific method and have an enthusiasm for living in the real world, this is something that like all of us us are about
And to that end, sometimes that influence is how we run, is how we decide to run our personal web-sites
Um, uh, that whether or not we want our, to give a platform to people who disagree with us, um, you know, uh, when we do, uh . . it it is our sandbox, you know, right ?
This, this, we’re allowed to to let whoever we want into our sandbox if we, you know, uh if we want
Did he, did he leave them up ?
Did he leave them up ?
Right, um, do you think that he is required to answer you
Right
Mhmm
Um so a a question uh why were why do you have so many Twitter and Wikipedia sock-puppets
Wikipedia
You left Wikipedia
Mhmm
Um a
Uh We have uh a response from David James, everyone uh gave you a fair shout
You were a spammer plain and simple
You couldn’t, you couldn’t
work out your questions
Twitter does not
Twitter does not block people for for arguing
Only for spamming and policy violations
Mhmm
Okay
Um, let me see
Each new account was blocked for additional violations of policies
Um, this is a uh uh referring to the Wikipedia rules too
Um, so
Um, Wikipedia, do you know why um they’ve locked the Burzynski page ?
Did you notice the part where he threatened, did you notice the part where he threatened to expose Wikipedia
We have to, well, they they uh are looking that it’s not one-sided information they want to show
Like they discuss, there is controversy about this guy
Yeah, Jaffe’s on there
Jaffe’s on there
uh well you could add that if you hadn’t gotten blocked
Okay
Um, so, who are you
She’s gotten threats
So we don’t know who you are
Like, she has suffered at the hands of some really mess, and she’s also, you have to realize she’s in the U.K, where libel laws are very lax at this point
That’s changing, ah, but uh, the the legitimate criticism, there is a big case last, me maybe 2 years ago of Simon Singh, talking about an alternative therapy, and, um, he was just saying that there’s no evidence for it but it’s promoted by um chiropractors, or something, or something like that
And he got slapped with a libel suit that cost him several years of his life and a lot of money
Um, so, there are several reasons why someone in the U.K. might uh be uh reticent to use their real name um, uh, and legitimate reasons
Um, in the U.S., I’m not sure that there is
I’ve been using my real name for a long time now
Um, you know, Gorski blogs under his real name, and is critical of uh, uh, also, let’s face it, everyone know, knows who “Orac” is
Um, how do we know that you don’t work for the clinic ?
Mhm
Well see, one of the the problems is, Ju, I don’t know if you were around for the BurzynskiSaves thing
Did you ever see that account ?
Mhmm
Right
Oh no, I mean you have a right to do that but but I I’ve found that posting under a pseudonym diminishes my credibility
Um, so, . . the quote was uh um, uh, “Happily promotes bogus therapies,” was Simon Singh’s quote that got him sued
Um, but Josephine Jones does it to, quote “protect her family”
Um
So there’s that
Um, are you afraid for you’re family ?
Um, you don’t see that there would be anything to gain from, from going on-record ?
Um I I haven’t, I’ve never, honestly, I’ve never seen a Skeptic actually go after a person individually
Um, you know, uh, you, unless they were doing colossal harm to people
Um, to to focus on an, uh, let’s say, call someone’s work for um, yeah
Cite one example, of a Skeptic making shit for a Burzynski shill or anyone else in real life
That’s a quote
That’s, that’s something coming in from, from Guy
Like had anyone ever contacted Sheila Herron, or has anyone to to um, go after her job, or go after um, you know, my brother has gotten stuff from people
He didn’t tell me because he didn’t want to upset me, but my brother gets things from Burzynski supporters that are violent and threatening
I get letters telling me that I suck cancer’s dick
Um, I I’ve all sorts of things um, and I just, I’ve never seen that, that intrusion into real life on the part of uh, um, uh, Skeptics
I’ve never seen them doing that type of of of stuff
I’ve never seen them threatening bogus lawsuits
Um, and I I I wonder there, if there is some sort of, what do you think accounts for that, that difference?
Mhmm
Mhmm
I’ve I’ve I’ve shown up on, you know, as you, as you might, I imagine you moni, you monitor the Hashtag, right ?
Okay
Um, which is, which is your right
Um, uh, but every so often I jump in and say, you know, this movie has some flaws in it
You know, that’s something I say rather frequently
Um, and I invite people, if they’re interested, to take a look at a couple of links
I don’t, I, you’ll notice that I no longer force people to like, “Well how do you explain this ?,” because that doesn’t seem to be very persuasive, or work at all
Ah, only people who are open minded to having their mind changed, those are the only ones I want to talk to
So I give them a choice
Kind of like Morpheus in The Matrix really
Um, b, that was a joke for me
Um, um anyway
Um, but, it it I, honestly, I would encourage you to go on-record, um, but I have, less than nothing invested in that, so, um
Uh, what’s next for you
Well what happens
Well what happens if he doesn’t understand what you’re saying ?
I mean one of the
I mean seriously
Well, one of the problems I think that a lot of Skeptics have had, in in back channel discussions about this is that we don’t understand exactly what you’re saying
We certainly don’t understand why you’re so attached to him if you’ve never had any uh, you know, close dealing with uh, uh, with Burzynski
We don’t really understand that
Actually, especially when you consider, that all the information that we’ve put forward, that we’ve backed up with statements from uh, you know, uh, it, it, the statements that we have from from patients saying that you know, we’ve we’ve, we were told that, no that’s not exactly, they put it usually that but that that we believe that getting worse is getting better
Like how could someone continue to defend someone, when we pile up all of these different, you know, sources, saying the same thing ?
It it is, it is beyond us and we wonder if there’s absolutely anything that we could say that would convince you otherwise
But, I mean, but that means
Everything on The Other Other Burzynski Patient Group is referenced
It goes
There’s very little on
thehoustoncancerquack
There’s very little on
thehoustoncancerquack in the 1st place
Eh, right
The they both go to the same place
Uh un but, you know, we, the thing that that totally befuddles us, and is just endlessly frustrating, is like how many more examples, of patients believing that getting worse is getting better, and it’s not us saying it, it’s the patients saying it
And how many more of those patients do we need to to give you before you will like reconsider that perhaps you might be wrong ?
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
The evidence would be
The evidence
The evidence would be phase 2 trials
And ev the evidence would be a completed and published phase 3 trial
That’s not forthcoming
The phase 3
You don’t know that he’s trying
He’d start completing these trials
And he would, he would be soliciting um, uh, lots of um, uh, you know, you know he’d be putting out papers constantly um and if the the British Medical Journal example’s anything uh representative of how Burzynski works, he’d immediately tell everyone that his he’s being . . blackballed by the, by the journal, even when it’s just a courtesy that he gets a a rejection
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
So, given that what would, how many more patients do we have to show you before you consider that you may be wrong ?
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
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
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
Um, so, uh, uh again, the FDA is not the arbiter of this
It’s ultimately Burzynski
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 ?
You’ve been speculating about what the FDA’s motivation are like crazy
Why not speculate about Burzynski a little bit
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 ?
What ?
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
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
Perhaps based on bad phase 2
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
Uh did do do you think that if they thought that he was a real doctor that they all would have refused like that ?
He’s changed things
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
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
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
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
He should have access to this
We can’t get it
How how long will it take before you recognize that, nothing is forthcoming ?
How long would that take ?
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’ren 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
Nothing thas 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 ?
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
Where has Eric been wrong ?
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
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
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
Um
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
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
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
Oh I, I I I certainly don’t think that he would put a lot of stock in it, but I, I, I know Dave Gorski enough, he wants this to work
He has patients who are dying, you know
And if if if let’s say that that Burzynski could get ah his gene-targeted therapy to work on breast cancer patients in in a reliable way, that would be, such a help to these people, that that Gorski’s trying to help
And, it it it doesn’t make sense, I mean, there, some of the best um, one of the the most important developments in medical history, was the development of of just washing your hands uh uh before uh uh going in and delivering a baby
Right ?
The guy who did it, was a colossal jerk, but it still worked and it’s the standard now
Right ?
Um, yea, it doesn’t matter now whether or not Burz, whether or not Gorski agrees with how Burzynski publishes
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
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 ?
Well what about all the other physicians, um, going back long before the Burzynski thing broke on-line
Of all these patients, with whom they have long-established relationships, and then doctors essentially after years, of treating these patients, basically saying, “I can’t work with you anymore if you go to Burzynski”
What about that ?
Di, are all of these doctors just as biased ?
Did he get burned at some point ?
We don’t know
Yeah, well, you wouldn’t expect Eric Merola to say that he got, that a doctor got burned
Would you ?
But he, he doesn’t have, he hasn’t given us his data
He’s given, he’s given, he’s given case studies
He’s done
Okay
Except for a ph, completed phase 3 clinical trial
Yeah
One of the things, one of the things that I’ve noticed going through these um, well, well there there is that
Uh, Guy Chapman, “It’s a blog, not a peer-reviewed publication”
Um, almost no treatment goes out without trials
Massive amounts of data are required
Um, so, it it is kind of, slightly disingenuous to hold uh Gorski to the same . . standard that you would, it on his blog
I think that professionally he would make, he he he would follow-up on these things, but u what I’ve noticed when you you mention these other people who are working with with Burzynski as co-investigators, the co- investigators don’t seem to have access to these, to these records
Um, you know, when they have to, when a patient has to, and often you have someone like a pediatrician, uh, signing on um uh to eh eh to work with with, uh and arrange care for patients when they’re out of state, away from Burzynski
Um, it’s it’s it’s often not an oncologist
It’s accurate to say that B Burzynski is not a board s uh certified oncologist
It’s accurate to say that no trial has been completed and fully published
Um, yeah it’s um, it it it if, all of the arguing on behalf of Burzynski doesn’t give him a single phase 3
It doesn’t give him um a uh uh of of a completed and and published phase 2
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
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
What is the issue were not talking about
Yeah, but they
But they have track records that support the idea that you should trust them
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 ?
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
You’re suggesting that they’re untrustworthy
I I would say that the the FDA has given Burzynski every opportunity for decades
Every opportunity
When he didn’t have r r really, he got special treatment as far as I can tell
Uh, the, I’m rather stunned every morning I wake up and don’t see in the paper, that that place has has been closed down
I, I really am
Uh, so, you know, that one doesn’t really fly with me either
Um
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 ?
Yeah, the the the it wasn’t the FDA who was pressing charges, it was a Federal prosecutor
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
The, no, claims works
He claims works
One of the things I think
One of the things that I think is happening here
One of the things I think is happening here, is that lots of people have worked with Burzynski and then have stopped working with B Burzynski
Uh, you know, uh lots of uh uh uh these partnerships do not seem to work out in the end
I often wonder, if the uh, the way that these things are, are are playing out, because it’s s so reliable that they’re, that these partnerships are going to fail, I I wonder if th they are designed in such a way, that for instance, um a, uh, a a partner would be uncomfortable working
with him
Or um or that the specifications for what it takes to enter one of these trials is so high, that nobody will ever enter the trials
I mean, I wonder if they are, what, especially, like why hasn’t Burzynski left the country ?
That’s what I want to know
Exactly
If he was so, if he was s so persecuted and really cares about getting his treatment out to the world, why wouldn’t he ?
They’re, they’re lots of things going on here
David James has pointed this out, that a lot of questions I’m asking are not going answered
“I still don’t know how long it would take before you would have any doubts about Burzynski”
“I still have no idea, how often we can see patients reporting that signs of getting worse are getting better, before you would change your mind”
I’ve made it very clear that he just needs to have a completed study published and replicated before I support his right to go out and charge people what he’s charging for these, for these drugs, and I’m I’m just not seeing that here with you, and I I wonder what could come from, and don’t worry I will go to your site and I will comment on on on what you’ve run
Um, but, you know, I I I I it’s hard for Skeptics to imagine, what could be gained from engaging with you, if there seems to be no conceivable way, that we can, one, get a straight answer for, how many patients will have to report that getting worse is getting better before you starting doubting your opinion, or, uh, how many uh, uh, how many years does this have to go on before you decide that, “No, we probably just can’t produce the goods”
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
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
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
Why wasn’t that study
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 ?
Why was the Mayo
Why was the Mayo study delayed ?
Well you said you had so many years before you finish it and go in
Why, why did it take so long ?
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
Um, because, I can ask that question of those researchers, why was this study in this time, and what happened in-between
Why did it take so long for it, for it to come out
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
I I, yeah, the other thing that David James points out is, you know, why 2016 when he’s had 36 years already ?
Treating people
You would expect the Burzynski Patient Group to be a lot bigger after 36 years, and in fact is
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”
Uh about the
The reasons, the reasons for which that he’s, no, why are you defending him so hard, when you’re unsure ?
I’ve backed-up everything that
Every time that I’ve tried
and then other people
Way back
It is about
It is about as efficacious
Yeah, I’ve, and and I based that on a a a that type of thing
You, you, you can read that how you want, right ?
There
He does have the accent though
Right ?
No
Alright ?
No, but listen, like, it it it’s not, it, we we don’t understand why you defend himself so hard, when there is such a paucity of of of information out there
Um
Even if it’s true or false you, honestly though
Even if it’s true or false, in in that particular instance, you know, eh let’s just say that you’re right
Gorski gets that point completely wrong
It has no bearing on whether or not, ANP works
That’s a Red Herring
You’re just focusing on this, on this little niggly stuff, where the real question, is does it work ?
Are patients getting better at a better rate then not
or otherwise ?
We’re were talking about whether or not there’s evidence to suggest it works
The FDA, see that’s the thing
You, the FDA are are, you know, you invest them with, we’re just, we’re just circling around again
Uh um, alright
Well, this has gone on for rather a, longer than I thought it would
Um, I, uh, wanna thank you for coming on here
I wasn’t sure that you would actually do it
Um, I’m glad that you did
I’m glad that we talked
Um, I will look at your web-site, and we will, uh, we, uh, you, oh make sure that I I go to your blog and and I talk there
Um
Please do
And I will look at those
Maybe not in the next few days; I’ve got a lot going on but
Alright
Um
I don’t think he is
I don’t think he’s afraid
I just think he’s got a lot going on
He is act, a full-time surgical oncologist and researcher
He does have insane am, he has to pick and choose his battles
And if, if if he saw that we were going to ultimately be circling around our same arguments again and again; kind of like we’ve done here, um, he uh, you, he doesn’t have time for that, I don’t think
Alright
I I would ask that you to to go back over The The Other Burzynski Patient Group and take their stories seriously, because they deserve at least the same amount of consideration that the survivors do
That’s my
That’s my kids, okay
Well, Thanks for much for talking
I greatly appreciate it
Alright
Take it easy

QUESTIONS the Critics and Cynics, “The Skeptics™” do NOT want to ANSWER

1. One “Orac” (Dr. David H. Gorski @oracknows @sciencebasedmed @gorskon #sciencebasedmedicine
http://www.scienceblogs.com/Insolence
http://www.sciencebasedmedicine.org)
claimed:


“Burzynski naturally has lots of excuses for why the trial failed and tried to blame the investigators, but his complaints are not convincing.”

When I requested that he respond to Burzynski’s comments re the study, he would NOT touch it with the proverbial ZZ Top

“Ten-Foot Pole”

What Critic, Cynic, or one of “The Skeptics™” is going to show more Bravery and Courage than “Orac”?
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2. If antineoplastons do NOT work, why, after Dvorit D. SAMID learned of them from Burzynski, did all the research, clinical studies, and phase I, phase II, and phase III clinical trials really start to get underway on
PHENYLACETYLGLUTAMINATE (PAG or PG)
PHENYLACETATE (PN)

and
PHENYLBUTYRATE (PB)?
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3. This individual claims to be a “cancer researcher”

If this individual’s “research” is so poor as a “cancer researcher,” what does that say about “research” re the “War on Cancer”?

My review of C0nc0rdance:
https://stanislawrajmundburzynski.wordpress.com/2013/03/23/my-review-of-c0nc0rdance/
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4. This individual claims to be a “Doctor,” “oncologist,” “breast cancer specialist,” and “cancer researcher”

If this individual’s “research” is so poor as a “cancer researcher,” what does that say about “research” re the “War on Cancer”?

Paging Doctor David H. Gorski, Paging Doctor David H. Gorski: There’s Mud in your Ears … Doktor Gorski?:
https://stanislawrajmundburzynski.wordpress.com/2013/05/28/paging-doctor-david-h-gorski-paging-doctor-david-h-gorski-theres-mud-in-your-ears-doktor-gorski/
He did NOT even refer to the below publication by Burzynski regarding “Treatment of Recurrent Triple-Negative Breast Cancer:”

8/2011 – Successful Treatment of Recurrent Triple-Negative Breast Cancer with Combination of Targeted Therapies
http://www.scirp.org/journal/PaperDownload.aspx?DOI=10.4236/jct.2011.23050
Journal of Cancer Therapy, 2011, 2, 372-376
doi:10.4236/jct.2011.23050 Published Online August 2011
(http://www.SciRP.org/journal/jct)
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5. Critics, Cynics, “The Skeptics™” state that Burzynski is NOT an oncologist, but can offer no explanation as to why this is supposedly “relevant,” they cannot explain if oncologists are somehow “better” than biochemists, nor do they want to answer the question:

“Does Burzynski work with any oncologists, and are any of them listed on his phase II clinical trial publications”?

http://www.burzynskiclinic.com/scientific-publications.html
Interim Reports on Clinial Trials:

16. 2003

DRUGS IN R&D
Drugs in R and D
(Drugs in Research and Development)

BT-11

BRAIN STEM GLIOMA

Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA:

a preliminary report.
http://www.ncbi.nlm.nih.gov/pubmed/12718563
Burzynski, S.R.
Lewy, R.I.
Weaver, R.A.
Axler, M.L.
Janicki, T.J.
Jurida, G.F.
Paszkowiak, J.K.
Szymkowski, B.G.
Khan, M.I.
Bestak, M.

http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs R D. 2003;4(2):91-101
Drugs in R&D 2003;4:91-101

Click to access 960.pdf

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6. The British Broadcasting Corporation (BBC) Panorama program indicated that 776 Burzynski patients with brain tumours were treated in trials before 2008
http://t.co/nFpwlQg275
15.5% (120) survived more than 5 years

Critics, Cynics, “The Skeptics™”, what’s your survival rate?
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7. March 29, 1996

Then United States Food and Drug Administration Commissioner, David A. Kessler told the American people:

1. We will eliminate unnecessary paperwork … that used to delay or discourage … cancer research … by non-commercial clinical investigators

2. The … FDA’s initiatives … will allow …the agency … to rely on smaller trialsfewer patients … if there is evidence … of partial response in clinical trials

I don’t want to get into any particular … agent … except let me point out … that … the information needs to be part … of clinical trials

3. We will accept … less information … up front –

4. we’re going to require further study AFTERapproval … because the science … has matured

5. The important – point … is that information needs to be gathered … through scientific means … through clinical – trials … and I think – that’s … that’s very important uhh very … important point

You can’t … just … use an agent here – or there … you have to use it … as part of a clinical trial … so we can get information … on whether the drug works

6. The uhh agency has … many … trials … has has approved trials … for patients … with antineoplastons

7. We are committed to providing expanded accessavailabilityfor American patients for any drugthere’s reason to believemay work
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/22/antineoplastons-has-the-fda-kept-its-promise-to-the-american-people
——————————————————————
A. What is the FDA’s definition of “unnecessary paperwork”?

B. What is the FDA’s definition of “smaller trials”?

C. What is the FDA’s definition of “fewer patients”?

D. What is the FDA’s definition of “evidence … of partial response“?

E. What is the FDA’s definition of “less information … up front”?

F. What is the FDA’s definition of “we’re going to require further study AFTER … approval”?

G. What is the FDA’s definition of “We are committed to providing expanded access … availability … for American patients for any drug … there’s reason to believe … may work”?

https://stanislawrajmundburzynski.wordpress.com/2013/06/08/what-is-misdirection-critiquing-antineoplastons-has-the-fda-kept-its-promise-to-the-american-people/
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8. The British Broadcasting Corporation (BBC) Panorama program indicated that 776 Burzynski patients with brain tumours were treated in trials before 2008
http://t.co/nFpwlQg275
Is that what the FDA means by:

rely on … fewer patients?
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9. 4/27/2013 (37:20) Fabio stated that
Burzynski had provided the FDA with 2.5 million pages of clinical trial documents

Is that what the FDA means by:

“unnecessary paperwork”?

and

“less information … up front”?
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10. Is this what the FDA means by:
https://stanislawrajmundburzynski.wordpress.com/2013/06/08/what-is-misdirection-critiquing-antineoplastons-has-the-fda-kept-its-promise-to-the-american-people/
if there is evidence … of partial response in clinical trials?
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11. Why was the United States Food and Drug Administration requiring that radiation be used in the Phase 3 Clinical Trial when Burzynski has shown better results with antineoplastons when radiation is NOT used?
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12. Who wants to defend the excuse that The Lancet gave for NOT Publishing the documentation which Burzynski sent to them, which is referred to in Burzynski: Cancer is Serious Business, Part II?
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13. Review Articles on Clinical Trials: 2. 2006 – Treatments for Astrocytic Tumors in Children: Current and Emerging Strategies. Pediatric Drugs 2006;8:167-178.

Click to access 1252.pdf

2006 Adis – Pediatr Drugs 2006; 8 (3)

pg 174

2.3. Targeted Therapy

1652 adults
335 children
[147]


indicates 1,799 Burzynski patients

Is that what the FDA means by:

rely on … fewer patients?
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13. The FDA approved phase III (3) clinical trials for Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal); which means that they have shown evidence of effectiveness, yet they have NOT granted Accelerated Approval for them, even though they have done so for other treatments which had NOT yet published the final results of phase II (2) clinical trials, and which did NOT have as good Complete Response, Partial Response, Stable Disease, Minor Response, Progressive Disease, Objective Response, Progression-Free Survival, etc., rates:

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/

(Additional QUESTIONS being added)

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References:

1.

Post #73 – Didymus Judas Thomas

At the Tu-Quack Center Oracles of Deny to Respond tree

1/30/2013

Post #52 – Orac

“You do realize that that means that the Mayo trial failed to find evidence of efficacy, just as I said, don’t you?”

“The default of a finding like that is that there is no evidence of efficacy, not that failure to have adequate numbers to show an effect means that there’s an effect there”

“If SRB wants to convince skeptics that his treatments work better than conventional therapy, let him publish the evidence in a peer-reviewed journal in a manner that it can be independently verified”

“Thus far, he has failed to do so.”

Orac, I thoroughly enjoyed; with a dismissive limp wrist, you posted:

“Burzynski naturally has lots of excuses for why the trial failed and tried to blame the investigators, but his complaints are not convincing.”
http://scienceblogs.com/insolence/2013/01/21/quoth-joe-mercola-i-love-me-some-burzynski-antineoplastons
Now, why don’t you tackle those ?’s?

1. “[T]he study tested a dosing regimen known to be ineffective.”

2. “[D]osages used in the study “were meant for the treatment of a single small lesion…”

3. “5 of the 6 evaluable patients had either multiple nodules or tumors larger than” said single small lesion.

4. “As the provider,” SRB “strongly suggested to the NCI that these patients receive a much higher dose, consistent with their greater tumor load.”

5. “[T]he study was closed when” SRB “insisted that the NCI either increase the dosage or inform the patients that the drug manufacturer believed that the treatment was unlikely to be effective at the dosages being used (letter to Dr M. Sznol, NCI, on 4/20/1995).”

6. “A review of the clinical data in the article … proves the validity of” SRB’s “position” per SRB

7. “Their study patients had extremely low plasma antineoplaston levels.”

8. SRB’s “phase 2 study dosage regimen produced plasma phenylacetylglutamine levels that are 35 times greater, phenylacetylisoglutamine levels 53 times greater, and phenylacetate levels 2 times greater than those reported…’”

9. “The clinical outcomes reported … based on their inadequate dosage schedule, differ dramatically from” SRB’s “phase 2 studies in which a higher dosage regimen was used.”

10. “They reported no tumor regression. In contrast, in 1 of” SRB’s “ongoing studies on protocol BT-9, 4 of 8 evaluable patients with astrocytoma had objective responses.’”

11. “The difference in outcomes is primarily due to the difference in dosage schedules,” per SRB

12. “Another factor that may have caused a lack of response in the study by … is that the duration of treatment was too brief.”

13. “Almost all the patients in their study received treatment for less than 30 days.”

14. “1 patient received only 9 days of treatment.”

15. “The current studies indicate that objective tumor responses are usually observed after 3 months of therapy.”

16. “An additional 8 months of treatment is usually needed to obtain a maximal therapeutic effect.”

17. “[A]mbiguities in the response evaluation and analysis in the article…”

a) “In 2 patients, tumor necrosis was attributed to “radionecrosis.””

b) “However, such an interpretation is clouded by the fact that antineoplaston-induced necrosis can be indistinguishable from radionecrosis.”

c) “Moreover, the analysis … could have highlighted the 2 patients with recurrent glioblastoma who survived for more than I year.”

d) “This is of interest because these patients typically have a life expectancy of 3 to 6 months.”

18. “It is regrettable that, at the time of the study … the sponsor, NCI, decided against the higher dosing regimen that I proposed and closed the study.”
https://stanislawrajmundburzynski.wordpress.com/2013/03/24/stanislaw-rajmund-burzynski-m-d-ph-d-and-freedom-of-speech/
IMPORTANT: The live “debate” that wasn’t-A Film Producer, A Cancer Doctor, And Their Critics:
https://stanislawrajmundburzynski.wordpress.com/2013/04/29/important-the-live-debate-that-wasnt-a-film-producer-a-cancer-doctor-and-their-critics/
Post #85 – Orac – April 28, 2013

“Well, DJT tried to comment last night and got caught in the moderation trap.”

“I’m not letting DJT through.”

“He’s been banned for very good reason, and I will not rescind the ban.”
http://scienceblogs.com/insolence/2013/04/26/all-truth-comes-from-public-debate-a-corollary-to-crank-magnetism/
My below blog contained a copy of the comment I submitted to his blog:
https://stanislawrajmundburzynski.wordpress.com/2013/04/27/important-the-live-debate-a-film-producer-a-cancer-doctor-and-their-critics/
All Mr. Hinton would have to do is ask “Orac” to respond to my post 73 on his blog, and it would be all over, since “Orac” has adopted his “Hold the Mayo” attitude, and shows no indication that he would ever be brave enough to touch it with the proverbial ZZ Top

“Ten Foot Pole”

because he’s probably aware of what would happen if he did

One of “Orac’s” “Oracolytes” posted on Forbes (#Forbes):
onforb.es/11pwse9

http://t.co/vh3cgAR6hW
“I already offered you a forum on a science blog to debate with a real respected surgical oncologist, with a guarantee that he never moderates the “debate”.”
http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics
IMPORTANT: The live “debate”-A Film Producer, A Cancer Doctor, And Their Critics:
https://stanislawrajmundburzynski.wordpress.com/2013/04/27/important-the-live-debate-a-film-producer-a-cancer-doctor-and-their-critics/
This is Dr. David H. Gorski’s blog

Dr. Gorski censored (blocked) my comments

We are supposed to believe that he’s now NOT going to block someone’s comments???
http://scienceblogs.com/insolence/2013/04/26/all-truth-comes-from-public-debate-a-corollary-to-crank-magnetism/
#66 – Didymus Judas Thomas

IMPORTANT: The live “debate”-A Film Producer, A Cancer Doctor, And Their Critics | Didymus Judas Thomas’ Hipocritical Oath Blog

April 27, 2013

Your comment is awaiting moderation.

Seriously ? Gorski ? Let’s remember that it is YOU who would NOT answer my questions, and instead inacted your “Hold the Mayo” posture re post 73

Let’s review your

“deconstructed his “evidence” in depth before” claim

1/21/2013 Orac posted THIS blog:

“Quoth Joe Mercola:

I love me some Burzynski antineoplastons

Posted by Orac on January 21, 2013″

” … In particular, a multicenter phase II trial carried out by investigators at the Mayo Clinic was a big failure, with a median survival of 5.2 months in patients with anaplastic oligoastrocytoma, anaplastic astrocytoma, or glioblastoma multiforme that had recurred after radiation therapy”

“Burzynski naturally has lots of excuses for why the trial failed and tried to blame the investigators, but his complaints are not convincing”
http://scienceblogs.com/insolence/2013/01/21/quoth-joe-mercola-i-love-me-some-burzynski-antineoplastons
I challenged “Orac” about this and this reply was posted which included my point at the beginning of the reply:

1/29/2013

“An excellent explanation of how dubious Stanislaw Burzynski’s activities are”

Posted by Orac on January 28, 2013
http://scienceblogs.com/insolence/2013/01/28/an-excellent-explanation-of-how-dubious-stanislaw-burzynskis-activities-are
Post #52 – Orac

January 29, 2013

“CONCLUSION: Although we could not confirm any tumor regression in patients in this study, THE SMALL SAMPLE SIZE PRECLUDES DEFINITIVE CONCLUSIONS ABOUT TREATMENT EFFICACY.”

“You do realize that that means that the Mayo trial failed to find evidence of efficacy, just as I said, don’t you?”

“The default of a finding like that is that there is no evidence of efficacy, not that failure to have adequate numbers to show an effect means that there’s an effect there”

“If SRB wants to convince skeptics that his treatments work better than conventional therapy, let him publish the evidence in a peer-reviewed journal in a manner that it can be independently verified”

“Thus far, he has failed to do so”

I responded to Orac, quoting his reply at the beginning of my reply:

Post #73 – Didymus Judas Thomas

At the Tu-Quack Center Oracles of Deny to Respond tree

January 30, 2013

Post #52 – Orac

“You do realize that that means that the Mayo trial failed to find evidence of efficacy, just as I said, don’t you?”

“The default of a finding like that is that there is no evidence of efficacy, not that failure to have adequate numbers to show an effect means that there’s an effect there”

“If SRB wants to convince skeptics that his treatments work better than conventional therapy, let him publish the evidence in a peer-reviewed journal in a manner that it can be independently verified”

“Thus far, he has failed to do so”

Orac, I thoroughly enjoyed; with a dismissive limp wrist, you posted:

“Burzynski naturally has lots of excuses for why the trial failed and tried to blame the investigators, but his complaints are not convincing.”
http://scienceblogs.com/insolence/2013/01/21/quoth-joe-mercola-i-love-me-some-burzynski-antineoplastons
Now, why don’t you tackle those ?’s?

[SOURCE: Feb. 1999 Mayo Clinic Publication pg 2, 3 PDF]

Click to access Feb99MayoClinicPubANP.pdf

2/1999 – A10 and AS2-1 – Phase II – Mayo Clinic Proceedings http://www.ncbi.nlm.nih.gov/m/pubmed/10069350
Phase II Study of Antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in Patients With Recurrent Glioma Objective:
http://www.mayoclinicproceedings.org/article/S0025-6196(11)63835-4/fulltext
To assess the pharmacokinetics, toxicity, and efficacy of antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261)
http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)63835-4
Design:
http://www.sciencedirect.com/science/article/pii/S0025619611638354
We initiated a phase II trial in order to determine whether evidence of antitumor activity of A10 and AS2-1 could be documented

Click to access PIIS0025619611638354.pdf

Comment in Jun; 74 (6): 641-2
http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.2003.01098.x/full
Mayo Clin Proc 74(2):9 (1999)
http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.2003.01098.x/references
1999 Elsevier Ltd.
http://onlinelibrary.wiley.com/store/10.1046/j.1365-2796.2003.01098.x/asset/j.1365-2796.2003.01098.x.pdf?v=1&t=hbs6xce2&s=3423e3cd1955667e8e8cdf33323faf0bd85b6a29
DOI: 10.4065/74.2.137
http://onlinelibrary.wiley.com/store/10.1046/j.1365-2796.2003.01098.x/asset/j.1365-2796.2003.01098.x.pdf?v=1&t=hbrndkdf&s=e0af2d3bfb13841852d92a839d3a4932a5f4bb48
Mayo Clin Proc 1999; 74: 137–45

Burzynski responded by pointing out:

6/1999 – A10 and AS2-1 – SRB http://www.ncbi.nlm.nih.gov/m/pubmed/10377942
Efficacy of antineoplastons A10 and AS2-1
S R Burzynski
Mayo Clin Proc 74 (6): 641-2 (1999),
Mayo Clin Proc. 1999 Jun; 74 (6): 641-2 Comment on Mayo Clin Proc. 1999 Feb; 74 (2): 137-45 PMID .10377942 Elsevier Science
http://www.mayoclinicproceedings.org/article/S0025-6196(11)64143-8/fulltext
Mayo Clinic Proc. 1999; 74: 641–642 (letter) 74 (6): 641-2
http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)64143-8
Mayo Clin Proc 74 (6): 1 (1999), 1999 Elsevier Ltd.

Click to access PIIS0025619611641438.pdf

DOI: 10.4065/74.6.641

This was responded to:

6/1999 – Mayo Clin Proc 74(6):2 (1999), DOI: 10.4065/74.6.641-a
http://www.mayoclinicproceedings.org/article/S0025-6196(11)64144-X/fulltext
Mayo Clinic Proceedings
Volume 74, Issue 6 , Pages 641-642, June 1999

Click to access PIIS002561961164144X.pdf

References:

1. SAMID D , Shack S, Sherman LT. Phenylacetate: a novel nontoxic inducer of tumor cell differentiation. Cancer Res . 1992; 52:1988–1992
http://www.ncbi.nlm.nih.gov/m/pubmed/1372534/

http://m.cancerres.aacrjournals.org/content/52/7/1988.abstract

Click to access 1988.full.pdf

http://cancerres.aacrjournals.org/content/52/7/1988
2. Danesi R, Nardini D, Basolo F, Del Tacca M, SAMID D . Myers CEo Phenylacetate inhibits protein isoprenylation and growth of the androgen-independent LNCaP prostate cancer cells transfected with the T24 Ha-ras oncogene. Mol Pharmacal. 1996; 49:972–979
http://www.ncbi.nlm.nih.gov/m/pubmed/8649357/

http://m.molpharm.aspetjournals.org/content/49/6/972.long
3. Chang SM, Kuhn LG, Robins HI, et al. Phase II study of phenylacetate in patients with recurrent malignant glioma: a North American Brain Tumor Consortium report. J Clin Oneal. 1999; 17:984–990
http://www.ncbi.nlm.nih.gov/m/pubmed/10071293/

http://m.jco.ascopubs.org/content/17/3/984.long
4. Thibault A, Cooper MR, Figg WD, et al. (SAMID D). A phase I and pharmacokinetic study of intravenous phenylacetate in patients with cancer. Cancer Res. 1994; 54:1690–1694
http://www.ncbi.nlm.nih.gov/m/pubmed/8137283/

http://m.cancerres.aacrjournals.org/content/54/7/1690.abstract

Click to access 1690.full.pdf

http://cancerres.aacrjournals.org/content/54/7/1690
PII: S0025-6196(11)64144-X

doi: 10.1016/S0025-6196(11)64144-X

1999 Mayo Foundation for Medical Education and Research.
Elsevier Inc.

The above four (4) references in the response to Burzynski might be relevant if all that antineoplastons consisted of was phenylacetate

Phenylacetylglutaminate (PAG or PG) and Phenylacetate (PN) are metabolites of Phenylbutyrate (PB) and are constituents of antineoplaston AS2-1

Antineoplastons AS2-1 and AS2-5 are DERIVED FROM A10

AS2-1=4:1 mixture of PHENYLACETIC ACID (PA) and Phenylacetylglutamine (PAG or PG)

National Cancer Institute (NCI) at the National Institutes of Health (NIH)
Antineoplastons
General Information:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page2
This is “what would happen” if “Orac” did have the “Bravery,” “Courage,” “Gumption,” “Intestinal Fortitude,” “Testicular Fortitude,” to address this issue:

Click to access BurzynskiTriesToExposeNCI.pdf

Burzynski: Managing social conflict in complementary and alternative medicine research: the case of antineoplastons:
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-managing-social-conflict-in-complementary-and-alternative-medicine-research-the-case-of-antineoplastons/
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2.
Antineoplastons: Phenylacetylglutaminate (PG or PAG), Phenylacetate (PN), and Phenylbutyrate (PB):
https://stanislawrajmundburzynski.wordpress.com/2013/06/17/phenylacetylglutaminate-pg-or-pag-phenylacetate-pn-and-phenylbutyrate-pb/
Phenylacetylglutamine (PG or PAG):
https://stanislawrajmundburzynski.wordpress.com/2013/06/18/phenylacetylglutamine-pg-or-pag/
Phenylacetate (PN):
https://stanislawrajmundburzynski.wordpress.com/2013/06/18/phenylacetate-pn/
Phenylbutyrate (PB):
https://stanislawrajmundburzynski.wordpress.com/2013/06/18/phenylbutyrate-pb/
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