All’s fair in Drugs and War

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GlaxoSmithKline
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$3 BILLION
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7/2/2012
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(4/1998 – 8/2003)
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United States alleges GSK participated in
preparing
publishing
distributing

misleading medical journal article that misreported that clinical trial of drug demonstrated efficacy in treatment when study failed to demonstrate efficacy
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At same time, United States alleges, GSK didn’t make available data from 2 other studies in which drug also failed to demonstrate efficacy
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(2001 – 2007)
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United States alleges GSK failed to include certain safety data about drug in reports to FDA meant to allow FDA to determine if drug continues to be safe for approved indications and to spot drug safety trends
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missing information included data regarding certain post-marketing studies
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data regarding 2 studies undertaken in response to European regulators’ concerns about safety of drug
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United States alleges GSK stated drug had positive cholesterol profile despite having no well-controlled studies to support that message
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Johnson & Johnson (J&J) and subsidiaries, Janssen Pharmaceuticals Inc. and Scios Inc.
Janssen Pharmaceutica Products, L.P.
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$2.2 BILLION +
——————————————————————
11/4/2013, Monday
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Johnson & Johnson (J&J) and Janssen
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complaint alleges J&J and Janssen were aware drug posed serious health risks, but companies downplayed these risks
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For example, when J&J study of drug showed significant risk of strokes and other adverse events in patients, complaint alleges Janssen combined study data with other studies to make it appear there was lower overall risk of adverse events
——————————————————————
year after J&J received results of 2nd study confirming increased safety risk for patients taking drug, but hadn’t published data, one physician who worked on study cautioned Janssen
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“[a]t this point, so long after [the study] has been completedwe must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”
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complaint alleges Janssen knew patients taking drug had increased risk, but nonetheless promoted drug as “uncompromised by safety concerns
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When Janssen received initial results of studies indicating drug posed same risk as other antipsychotics, complaint alleges company retained outside consultants to re-analyze study results and ultimately published articles stating drug was actually associated with lower risk
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J&J and another of its subsidiaries, Scios Inc.
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8/2001 – FDA approved drug to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity
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approval based on study involving hospitalized patients experiencing severe heart failure who received infusions of drug over average 36-hour period
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complaint alleged Scios had no sound scientific evidence supporting medical necessity of outpatient infusions and misleadingly used small pilot study to encourage serial outpatient use of drug
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Abbott Laboratories Inc.
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$1.5 BILLION
——————————————————————
5/7/2012, Monday
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(2001 – 2006)
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company marketed drug in combination with atypical antipsychotic drugs even after its clinical trials failed to demonstrate adding drug was any more effective than atypical antipsychotic alone for that use
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1999 – forced to discontinue clinical trial of drug due to increased incidence of adverse events, including
somnolence
dehydration
anorexia
experienced by study participants administered drug
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funded 2 studies of use of drug
both failed to meet main goals established for the study
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When 2nd study failed to show statistically significant treatment difference between antipsychotic drugs used in combination with drug and antipsychotic drugs alone, waited nearly 2 years to notify sales force about study results and another 2 years to publish results
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AstraZeneca LP / AstraZeneca Pharmaceuticals LP
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$520 MILLION
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4/27/2010, Tuesday
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engaged doctors to conduct studies on unapproved uses of drug
——————————————————————
recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies doctors in question didn’t conduct
——————————————————————
then used
studies
articles

as basis for promotional messages about unapproved uses of drug
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REFERENCE:
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11/26/2013 – United States Department of Justice (DOJ) versus BIG Pharma: BIG Pharma fought the law, and the law won ?:
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https://stanislawrajmundburzynski.wordpress.com/2013/11/26/united-states-department-of-justice-versus-big-pharma-big-pharma-fought-the-law-and-the-law-won/
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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)
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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)
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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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Pete Cohen chats with Richard A. Jaffe, Esq.

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4/2012Pete Cohen chats with Rick Jaffe
(33:59) 11/9/2012
Richard A. Jaffe, Esq.
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How did you meet Dr. Burzynski?

A long time ago in 1988, um, he hired us to represent him in his Medical Board case, so, uh, started working for him then, and then there got to be more and more work, and, uh, at some point it was so much work, it was just easier for me to be down here
So I moved from New York to Texas, mostly just to, to represent him, and my wife was in the oil industry, so, it was a “no brainer” for her to move down here too

And how, were you intrigued by this whole case ?
I mean, did you work out straight away that this guy was genuine, and there was really something here ?

No (laugh)
How do you know, you know ?
At the time we represented, uh, a number of a alternative health practitioners around the country, and we heard a lot about Burzynski, but you don’t really know
I mean, um, um, there are a lot of stories out there
Every doctor seems to have a few patients, uh, that were helped
So initially, I mean, how do you know ?
His operation was larger than most of any, uh, health practitioners, alternative health practitioners in the country, and, uh, seemed a lot more sophisticated, but, uh, it’s not really until you dig in the medical records of the patients that you really see what’s going on
I mean, that’s what you really need
I mean,
It’s not really even, it’s
’cause this whole thing about anecdotal evidence, that everyone has testimony
so every doctor
You know what I mean ?
anybody
Even charlatans have testimony
people
one or two people
or 3 or 4 that’ll come, and say w
they were cured, and maybe, maybe the patients really believe that to be the case, but, um, oftentimes there’s other explanations
Prior treatment, um, the nature of the disease
Sometimes it’s such that their natural, the natural history is not straight linear, um, but after looking at some of the medical records, I mean, you know, I think
it’s just,
uh, anybody would become a believer, and indeed, I mean, government, government doctors have come down here and looked at

some of the records, and they were convinced that, that the treatment was causing remissions in some brain cancer patients

So, I mean, obviously lawyers, I imagine many lawyers all over the world would often take on a case, when they know, possibly the guy isn’t telling the truth, but they can see there’s still a story, and they, they, they, they, uh, represent that person, but for you, I suppose
that when you realized that there really was a story here, did you kind of get, emotionally caught up in this whole thing and think: “Right, th this guy’s got a cure for cancer, and I I need to bring this to, bring him to just, not bring him to justice, but, clear his name
Well, I think with Burzynski, more so than any client I’ve ever represented
He represents a unique constellation of medical services
He’s the only guy in the world doing what he’s doing with antineoplastons and now with this treatment, so, it’s really different
Uh, you know, with Burzynski, most of the patients, are in bad shape
They’re either dying, uh, they, or they have a disease for which there is no known cure, you know, like a lot of these brain tumors
So, even from the beginning, what’s different is their are many, many patients back then who were on the treatment, that uh, that felt that without this treatment they were going to die, and so that, that’s much different, than the average, any kind of lawsuit
Right ?
So th th these lawsuits, the Burzynski cases back then and now, uh, these cases matter, in a, in a deeper, and fundamental, and personal way than most anything, well I think that any lawyer does
I mean, any criminal defense lawyer, who defends an individual, is defending that person’s, uh, liberty
Alright ?
Versus incarceration
But here it, it wasn’t so much, or, it wasn’t exclusively about Burzynski, it was really about all these other patients, and they certainly believe they needed him, and, uh, uh, many of them, obviously did
So, so that, that, that’s a whole ‘nother dimension, which typically we lawyers don’t get involved in
So, I mean, it’s a responsibility but also a great privilege to be working on these kinds of cases

You’ve been representing him for how long ?

For a long time
Since 1988, continuously

And can you believe this is still going on ?

Well, you know, uh, it’s, you know, it’s, it’s just ongoing
I mean, until there’s a cure for cancer, for all cancer, either done by acknowledged

or, uh, uh, to be Burzynski’s cure or somebody else’s
I mean, this is ongoing
And I guess the problem is, you know, ultimately, there’s nobody yet
Not even Burzynski has the cure for every cancer or
even every stage, or even ev, every, ev, ev, every person that had cancer
So, because it’s such a tough battle, and because, it doesn’t work on everyone
So you have these open questions
Ah, so, so,
Yeah, I mean, I guess, I, I can’t believe he’s still messing around with these clinical trials
I mean, I think that if the drug didn’t have his name attached to it, it’d probably would have been approved by now
So, and I think, so that, that’s unfortunate, I think, that when you fight the FDA, and even if you win, you know, the F, the repercussions, you know, you know I, you know I
Hopefully the drug will be approved, sometime in the future, but, but who knows ?

So, um, why do you think, why was it, I mean, obviously I came over here as you know, for this case, which is now not going ahead at the moment
Why, why, why is that ?
Wha, what has the judge, said ?

Well, of course, you have to (under)stand, this case involves a different type of treatment
It doesn’t involve antineoplastons,the drug Dr. Burzynski invented, and your friend is receiving, and it involves a new approach to cancer, which is sort of like personalized medicine, where they take a bunch of FDA approved drugs, that have shown some promise, on a particular cancer, but are not, uh, approved for that indication, and based on these early clinical trials showing promising results for genetic testing they give these combinations of FDA approved drugs, off-label to patients, and that’s really what the, this case is about, and, uh, you know I think, I don’t think they, they never had a case
I mean, they never had a case
The, the main allegation, in each, of the 2 patients involved, is that they used this treatment, which wasn’t sufficiently tested, and was non-therapeutic, and whatnot, and we had a, what I would call a dry run
We presented the evidence to the Board, or 2 members of the Board, in both of these cases
In each, in each case, the Board members felt that the treatment, was within the standard of care, given the advanced condition of the patient, or one patient, and given how rare the other patient’s tumor was
So, we had our dry run in each case, and the Board found in our favor on the main charge
They had some technical issues with medical records or whatnot, and, uh, the Board basically said, they took the position, ok, agree to some kind of sanction on these little charges, or, or we’re going to go after you on everything
So, we refused the honor, and, uh, the Board then charged him with the same thing that they already cleared him with, or on, and, and so we had to do, you know, basically the same case again, and, uh, the irony in, is in these 2 cases Burzynski wasn’t even in the country
He was, he was, he was away for, uh, in both, for both cases, when the patientscame
So, uh, the question is how do you hold someone responsible
Even if you own the clinic, for treatment administered and prescribed, by other doctors, and that concept of vicarious liability does not, uh, exist in jurisprudence, and in the law governing professional re, responsibility, anywhere in this country
So, the Board’strying to start that
You know, I think they just got in over their heads, they
Most people just knuckle under
You know, most people don’t, are afraid to go to court, so they’ll sign anything just to, you know, not to go forward, but, you know, Burzynski faced serious stuff
I mean, he set, faced, 5, 10, 15 years in jail
So he wasn’t going to be intimidated, by the Medical Board, and he refused to give in
So when I told the Board at the time, and I told them all along, they have no case, and o on the merits they have no case
We already won, and they have no case now, and, and slowly I think, the Board is starting to understand that

And what sort of a person would you say Dr. Burzynski is ?

Well I think he’s a complicated person
I mean, I think, uh, uh, you know, he, I think like a lot of mavericks; I represent a lot of mavericks around the, uh, uh, country
One of the main characteristics of these guys, is that they have absolute and total certainty, in what they believe in, in what they do, um, and no doubt
Uh, they all think they’re right
They all think that history is going to vindicate them
Now, I’ve represented some people where I personally doubt (laugh) that, uh, uh, that belief, but not in Dr. Burzynski’s case
I mean, I think he’s all, he’s definitely helping people
He’s definitely, uh, uh, uh, making, extending people’s lives, and curing some people that otherwise would have died, and so I think he, and so I think he happens to be right
So, uh, you know, so, but, but he’s a human
He’s got a big ego
He thinks he’s, uh, he thinks he has made an important, contribute to medicine, and he’s not shy about sharing that sentiment
So, uh, I think, and I think that he’s, uh, not American
So he comes with a completely different mentality towards, say, the government
Alright, he grew up in communist Poland, where everyone, where everyone, has to work around, the government, and I think that’s much harder here, and, you know, I think he has expectations that, that he would have a lot more freedom, than it turned out he had, too, and he thought he would not have to deal with the kind of government, uh, rigamarole that you have to deal with in communist, Poland

And, and how do you think it might all pan out for him ?
I mean, I know you don’t have a crystal ball, but if you could look, 5 or 10 years down into the future, and, do you think that he will have got somewhere, to be accepted in the medical (?) of oncology ?

Well, I certainly hope so
I mean, 5, 10 years from now
I mean, I think, at a minimum, what’s going to happen, there will be many, many patients who will be alive, and continue to be alive because of him
Some, will have their lives extended
Some will be cured
Some wi, won’t be cured, and will die
So, I think that’s for sure, going to happen
You know, is there going to be an end to, uh, all this ?
We had a period of maybe 10 years where there was very little action with the Board, but, uh, you know, it’s hard, frankly, I mean, just in, and again my perspective, like I’m in a, like a, a sergeant in the trenches, in trench (laugh) warfare
So, it’s hard for me to see the big picture
I mean, I just keep fighting these battles, and there’s one, after another, after another
So this is really just the latest, and on there’s civil lawsuits, and then there are people on the Internet, and then, you know, there could be more Medical Board investigations
So, lo, look there are a lot of people who don’t like what he’s doing
They think what he’s doing is either unethical or wrong, or shouldn’t be giving drugs, these drugs to people, except under clinical trial conditions, and, you know, he has detractors, and he has a lot of supporters
I mean, uh, mostly amongst the patients he’s cured
So, I don’t know that, that, that is gonna resolve itself
I mean, ultimately, he’s one of the few people in the country, that, or maybe the only person in the country that does what he does, and, it’s not the way medicine is practiced, in this country, typically
Right, and, you know, I think what he does, is, is more, is more patient oriented, in a sense that, once you’ve been told you’re terminal, why should you just get the palliative care that a medical oncologist thinks, you know, they should be given
even though when, no one ever gets cured of chemotherapy, once it’s palliative, once you have stage 4, solid tumor

Mmm

I mean, they give chemotherapy for what they call palliative reasons, which means, not curative
So, this concept of giving, just conventional chemotherapy to make you feel better, extend your life 9 weeks, I mean, y, not everyone wants to do that
Some people want a shot for a real cure, and, you know, based on the evidence with antineoplastons
, I mean, he seems to be giving people that shot, and curing some of the people
So, you, you know, I don’t see how, this thing gets resolved
Up until the time that the
treatment, the
antineoplastons is approved by the FDA and, you know,
it’s, it’s hard to see a clear path, for that, for a lot of reasons, not the least of which is financial
I mean, it takes dozens of 10’s of millions of dollars

Mmm

or 10, 100’s of millions
So, I mean, someone has to finance the clinical trials
The drug companies aren’t interested right now
They’d just as soon, buy a drug that’s been fully tested
So, I mean, the drug company response has not been overwhelming, because, even though this phase 2 phase, have resolved, and, and, uh, they have excellent results, the drug companies want to wait and see
So, uh, it’s, it’s big money
I don’t think there’s any way in the world Dr. Burzynski, himself, can fund phase 3
I mean, he, he funded everything else now, but phase 3 are, is a much bigger stage involving dozens and 100’s of patients, and that’s just within the financial means of any individual

it seems like it’s unlikely that its going to happen right
I mean, even from the point of view of, what, with phase 3 trials, they’ll be with children

with brainstem gliomas, right
and the FDA’s saying they’ve got to have radiation

Yeah I, um,
I unfortunately, I haven’t been involved in that process
I just see the result, and I, I, I just don’t see how any parent agrees to that, you know

I don’t see how any parent agrees to it
I don’t see how clinical investigator, agrees to do it
Um, I don’t know
I got so, I got some questions of the FDA as to, why they forced him into this particular protocol
I mean, I don’t know
I don’t have any facts or evidence, but I, I, just doesn’t make any sense to me

what’s you’re about that ?

I don’t know
I mean, I, it just doesn’t seem to me, that it’s a, that it’s a fair clinical trial that

Mmm

either an investigator would find ethical, or a patient, or a family, would agree to have their patient treat, their, their kid treated under
I mean, it just doesn’t make any sense to me
I mean, it’s worse than
I mean, both phases, both phases, both arms of the study, you get radiation
It’s radiation alone versus radiation with his stuff
So, I mean, it just doesn’t make any sense to me, given, given the clinical, the phase 2 clinical trial results

So just a, so just a few things, like, you know I’m going to talk about big Pharma, and then talk about the FDA

Right

They talk about the many people as if they’re one person, but, you know, they’re obviously a collective group of individuals who work for an organization, right ?

Well, I mean, I think, the concern is, that the FDA now, by statute is, in no small part funded, by the pharmaceutical industry
It’s like “Pay as you go”
So the, the pharmaceutical ind, industry now, pays for, the processing of the clinical trials by the FDA
So, and then you have the whole concept of the revolving door
You have a lot of government officials going into the drink, uh, drug companies
So I think that’s another problem
So, I mean, you know, I think conspiracy is too strong of a word, m, but, you know, I will say, I don’t think the system’s set up, for an individual like Burzynski, to get a drug approved
I, I, I just don’t see
There’s no support for that
I mean, the days
I mean, it’s like, Einstein, you know ?
He sat in a patent office, and, and doodled, and had his little theory
He could never get his, stuff published today, you know ?
Where did he go to school
?
Where was he teaching, you know ?
So Burzynski has a lot of the same problems
They say he doesn’t publish, but, they won’t let him publish
So, uh, or they won’t let him publish , in, in the mainstream journals
So, I, I, I think though, I think the, I think the system, has a strong bias, against a guy with a discovery
So, that’s not quite saying, there’s a conspiracy, but it’s, it’s sort of along the same lines, and, you know, the conspiracy implies some kind of, um, intentionality on the part of one or two, or some small group or coterie of people, and I don’t know, I don’t think that’s really the case
I think what happens is, the institutions are such that, they allow certain things, and disallow certain things
Alright ?
I think that’s just
there’s no
I don’t think there’s any 2, 3, 4, or some, coterie of Rocka, they’re like a Rockefeller conspiracy
People are saying that there are 12 industrials
That they control the world
I mean, I don’t see that happening, but, the whole system is such that, you know, it’s, it’s
I guess what, uh
The, there’s a book by, uh, a, a, Thomas Kuhn, the Structure of Scientific Revolutions, and he talks about, normal science, and how science progresses, in terms of paradigm shifts
So, normal scientific medicine, works, uh, by big institutions doing, studies about combinations of drugs, after drug companies, invent mostly, modifications of existing drugs, and, less commonly, completely new drugs, and, uh, less commonly, different classes of drugs
So, you have a whole, you have a whole pipeline from a drug company, a whole, uh, uh, mechanism of testing, by the universities, funded by the pharmaceutical company, uh, all the pharmaceutical companies, and that, that just doesn’t lend itself, to one guy, sitting someplace in Houston, or wherever, and having a drug, put through that process
That just doesn’t happen
Burzynski is, so far as I can tell, the only person, to ever completed, a phase 2 trials on a drug he invented
I don’t think that’s ever happened, before, and I don’t think it’ll ever happen again

Ah, was it ’98, was it the chairman, uh

Kessler ?

Kessler
I saw, an interview he gave, press, a press conference where he was explaining about, being able to fast-track
The FDA trying to make it possible to fast-track, you know, drugs that have shown, you know, positive, rather than going through all of this sort of clinical trial, and there’s a guy in the, in the press conference who started asking questions about Burzynski

Right

and you could just see quite clearly he was very uncomfortable

Right

asking questions about, uh, about Dr. Burzynski
How do you think someone like him,
would view, someone like Dr. Burzynski ?

Not favorably
I think that, uh,

Do you think they must know ?
Do you think they must, even he, let’s just say, if he were on his own, he, he knows there’s something there
That he’s obviously got something

I,
I don’t know, uh
I think, that, the guys in conventional medicine, because Burzynski came from orthodox medicine
He was at Baylor
He was a researcher at Baylor
So, I think, they’re not going to Burzynski, is that, he didn’t go about it, the way, other physicians would have done it, other scientists would have done it
So normally what would happen, is, uh, uh, I mean, I think the critical, point in his story is that, when he was at Baylor, and his, uh, professor was supporting him, this Unger, left, you know, they had space for him
They wanted him to go in the Oncology, uh, Department, but, they wanted the patent, to his drug, and he wouldn’t do it
So, that would have been the more conventional approach
You give up the patent rights, you become part of the team, then some big institution, uh, uh, shepherds the drug through, and then they find some drug company support, who will split the patent with the university
So, had he done that, uh, you know, I think the drug woulda been approved by now, but, you know, it was his drug
He came to America with it, and he wasn’t going to give it all away
So, I mean, I just think that’s, you know, I mean and that’s, you know, I think he wasn’t expecting that kind of thing in America
Maybe in communist Poland, but not in America
So I think that really, you know, set him down the path of being a, a, an alternative health practitioner

And wha, wha, what was it like for you when, uh, winning, the case, in was it, 199, 3, 1998 ?

’97

1997

Well, you know, there wasn’t just one case
I mean, I mean, it was everyone
I mean, I analogize it to, like whack-a-mole, or whack-a-rat, you know
You have, like a rat come out of, of a hole, and you bang him, and one comes out of this hole, and all of a sudden you’ve got 2, and then 3, and, so, you know, during the early ’90’s, I mean, I mean, there were 3 grand juries, uh, we had the Medical Board action, which went to hearing in ’93
The Texas Department of Health sued him in ’92
Half a dozen insurance companies had sued, uh, uh, sued him for, for some, for Racketeering
Uh, Texas Air Quality Department went after him
I’m trying to think who else
So, all of this happened, over the course of 3, or 4, or 5 years, and it was just, continuous, and so, one agency would, would get active, and then, they get beaten down
Then somebody else would come, uh, come up, and surface, and indeed, I mean, you know, it, you know, some of them flat out said they were waiting to see what happened, with this oth, wha, what happened with this other agency, and they weren’t gonna do anything, and then when they got tired, they decided, that this new agency had to do something
So, I mean, that was flat out, what happened
So, yeah, I mean, it culminated in the criminal case, I suppose, but even there it was up and down
I mean, the judge ordered, uh, ordered, prohibited him from giving the treatment to anybody else, because the Texas Medical Board case, ultimately went against us, and then we had to go Congress, and Congress forced the FDA to put all his patients on clinical trials which made the Medical B, Board case moot, and then we won the criminal case
So, after we won the criminal case in, uh, ’97, things got quiet for a little bit
So that, that, that was good
I mean, it was quiet
I mean, relatively quiet, and then, uh, lately in the last couple years it’s been very active again

So the worst case scenario would have been
What would have been the worst case scenario ?

For when ?

And this, this
What could have happened this week if the case had gone ahead ?

Well, the worst case scenario would be, there would be a finding, that, that it’s a depart, it’s a departure from the standard of care to use, uh, off-label drugs, that haven’t been approved by the
FDA for an indicated use, and you can’t use the combination of the drugs until someone gives the stamp of approval saying that their safe and effective, which means, you know, you couldn’t, it couldn’t, you couldn’t give the treatment anymore to patients
So you have 100’s of patients that are on this multi-agent gene-targeted therapy, and ultimately that form of treatment is only available at the Burzynski Clinic
I mean, I don’t think that even clinical trials
Burzynski, depending on how you look at it, he’s a few years ahead of, of, uh, well, even the clinical trials
I mean, they’re some clinical trials now on different kinds of cancer where they’re doing 1, 2, or 3 agents
He’ll use 4 or 5, albeit, lesser dosages
So he’s treated 1,000’s of patients like that, but there’s no place else in the world where people can get, the treatment
So it’s kinda the same thing as back in the ’90’s
We have people on drugs, uh, which are unavailable, uh, and, only available through Burzynski
So, if he couldn’t give them, to people, then they wouldn’t get ’em, and, they’re terminal, and, they’re doing well
I mean, or they’re not going to do as well, or they’re going to die
So, it’s, I guess it, it’s sort of the same thing here, ah, uh, only, uh, the irony is all these drugs are, approved by the FDA, and most cancer patients get off-label, uh, drugs
Drugs off-label
So that’s, very common in cancer
It’s just that not common with the drug used on these patients, and in the combinations used

So, this finally
Whe, when you’ve, uh, won these cases, I mean, there must be, it must be good, right ?
It must be good feeling

I had a good feeling last week
I mean, I mean, you know, or I’ve been working non-stop, for months, every day
I mean, there’s no day off in this kind of stuff
It’s just constant
It’s just, his war
There’s always something to do, and then I’m a solo practitioner
So, when the judge cut the heart of the Board’s case out, I’ve been telling the Board, that they can’t, that they have no basis to, to, to bring charges against him, for several years, since 2010
, 2009, and they’re not listening, and, and, I was pretty sure that once you had a judge look at the case, they would, rule in our favor, you know, but the problem is the Board is, like a law unto themselves, and they think they can do anything, and, uh, they just changed the law, in September
So actually, the Board has no recourse
They, they used to be able to change findings of facts, and conclusions of law, but as of September, 2011, they can no longer do so
So, if the, judges’ ruling s, uh, stands, as I think they will, their only remedy is going to be to appeal to a State District Court, and they’re not used to that, because they, like exercising, uh, complete authority
So, they’re in a new position, and I’m sure this is the 1st case, that they’ve ever, not gotten what they want to, from, from a judge, administrative law judge, and not being able to correct it
So, I mean, that, this is a good ti, completely new experience for the Board, and I feel bad for them (both: laughing)

You, you, you do
As a Board they all sit down, and as a group of people, and talk about Dr. Burzynski, and, and, and work out how they’re gonna bring him down, and then ?

Well, that’s more the conspiracy
I, I, I, I think that, some of the Board members, may know of him
He, but, but, but like I say, he’s appeared in front of these informal settlement conferences, and basically, individually they, I mean, exonerate him, of, of the main charges, but I, I, I think that, you know, when we talk about the Board, the Board other than these a, acting informal settlement conferences, where you have one Board member, and one member of some district disciplinary review committee, we’re not really talking about the Board members, these doctors, and lay members of the Board, we’re talking about the Board staff, and that’s the lawyers and administrators of the Board, and I think, you know, I don’t know
I have some, uh, uh, they need to clean house
I mean, they’re getting some very, very bad legal advice, and I, I just think the legal advice at the top, is, is, is horrible, and, and they need to make some dramatic changes, and I think it would be better for the people of Texas if they, just did some house cleaning with the administrative staff there

And what do you think about the way that, uh, Dr. Burzynski’s been , what’s the word, in England, he’s got a very bad press there

(Alright ?)

and, um, why do you think that is ?

Uh, why, well, I mean, look
I mean, I think, people have opinions
They’re,
they have the right to express opinions
I mean, I think, uh, some of his agents did some things that I think, were not wise, in retrospect
I mean

Mhmm

Uh,

The stuff with the, this kid, this blogger

Yes

(?)

And I think that, uh
I think you have to be very careful, about what you tell people that are expressing opinions, and, you know, I mean, I, I, I think, you know, I think there’s a reason why, lawyers get involved in these cases, and should be involved, and I think what happens is, you know, I think there was a, you know, a well meaning, individual, who just went too far, and I think stirred things up unnecessarily so
You know, I mean, I think someone who had some legal training, acting on Burzynski’s behalf, might not have made some of the, you know, just faux pas that were made
So, I mean, that stirred, some things up, and I think

(?) stirred something up that was already there ?
You know, ’cause, I know, I’ve spoken to so many people in the U.K., and, uh, and you find very few people that have anything positive to say
In fact, a friend of mine who’s a famous doctor on television, when I was here, he was on British television with a little girl, and her father, who were trying to, uh, raise money to, um, come over here and, um, in fact, they couldn’t come anywhere, come, they couldn’t come anyway, because, the, uh, FDA said that this type of brain tumor, she couldn’t be treated anyway
But this doctor, who’s a friend of mine said, uh, Dr. Burzynski is, you know, he’s a medical pioneer
He’s, uh, uh, he said that and then literally, for 2 months, non-stop, I think especially on Twitter, they said that he never should have said this, and the guy is a quack, and he’s a, he’s a fraud, and

So your, your friend got in trouble for saying that he’s a pioneer ?

He didn’t get in trouble, but I mean he got a lot of bad press, for speaking on television with this child next to him, saying that, Dr. Burzynski was, you know, a pioneer, and pioneers often have a hard time, and

Right, right

And, you know, you look at Twitter, uh, you probably don’t
You could be (laugh) and you just see, it’s probably, probably the only, 30, hard, hard core people, who spend, all of their time, trying to

Yeah, I think that’s right
I think it’s a very small group, of people, that are making pretend it’s a big movement
I mean, we’ve looked, at some of the traffic
We’ve analyzed some of the traffic
I don’t even think it’s 30
I think it’s more like, 3, or 4, or 5, that are creating things, and then someone had some friend who’s an actor, who has, you know, 3 million followers, and all
So it’s really a very small group of people, but historically, medical doctors who have stood up for Burzynski, have had negative consequences
We had, someone from the National Cancer Institute, NIH testify, this Nick Patronas, and he got in a lot of trouble for doing that
So, you know, it’s not, it’s, unfortunately, you know, speaking up for Burzynski can have, uh, negative career consequences, or, or just some bad P.R., but that’s, part of being a pioneer
It doesn’t mean that, uh, Burz, I mean, if anything, I mean, it shows, it shows that’s like the medical mafia
Yeah
So, that’s what I call, the church of medical orthodoxy
So, that’s what I call
So

Well I, I think it’s gonna be so interesting when I get this film broadcasted, to see what kind of reaction we get
It, it’s just a story I felt I had to (?)

Where are, where are you going to try and get it ?

I’m going to try and get it
I know people at the BBC

Right

I’ve worked in television
So I’m going to try

Oh really, (?)

I’m gonna try those avenues, but you know what ?
Even if it doesn’t

You have cable
You have some kind of public access ?

Yeah
I’ve, I’ve worked in television for years
So I’ve, I have a very good stab at getting it out there, but if I don’t, I’ll get it broadcasted on the Internet

Oh sure
You do, do a YouTube or something, or do what Merola did as a documentary

(?)

That’s had an amazing impact

Yeah
He’s making a sequel
Eric was just over in England

Oh really ?

I looked after him when he came over

Yeah
He wanted to talk to some of the patients and doctors

Eric, I said, ah, you know, so, we’ll see
But listen, I really appreciate the opportunity to ah

Ok, no problem

really, to be able to talk to you
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http://www.richardjaffe.com
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