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
======================================

======================================
http://www.richardjaffe.com
======================================

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

20131021-200529.jpg

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

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

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

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

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

“And it’s always been his burden of proof

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

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

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

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

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

Subpart F–Confidentiality of Information

Sec. 601.50

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

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

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

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

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

Burzynski ?

FDA ?

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

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

“It is Burzynski’s job to be convincing”

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

“In decades”

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

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

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

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

“It’s ultimately Burzynski”

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

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

“That doesn’t”

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

“How long would it take ?”

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

“Years ?”

“How long ?”

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

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

“I can do that”

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

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

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

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

“You’re you’re you’re assuming”

“You’re you’re you’re assuming that”

“You’re assuming that”

“Um, I’m not assuming that”

“There is a correct answer here”

“You don’t know”

“You don’t know”

“You need to look into it”

“Alright ?”

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

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

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

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

“I try to fight against it, constantly”

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

“He withdrew the the phase 3 clinical trial”

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

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

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

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

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

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

“What about the the Public Library of Science?”

“It’s not the only journal there”

“What about BMC Cancer ?”

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

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

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

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

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

So

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

“How long will it take ?”

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

“We can’t find it anywhere”

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

“We can’t find that anywhere”

“We’ve asked”

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

“And, and it hasn’t come to us

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

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

1. Annals of Oncology 2010;21:viii221 ?

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

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

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

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

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

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

“We’re talking about life”

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

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

“This is important stuff”

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

“It’s nothing”

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

“You know”

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

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

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

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

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

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

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

You know, I don’t necessarily agree with that

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

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

“You know”

“They’re just saying, “No thanks””

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

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

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

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

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

“Is that what you’re saying ?”

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

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

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

“I mean you just can’t

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

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

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

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

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

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

“Right ?”

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

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

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

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

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

“Right ?”

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

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

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

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

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

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

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

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

“The FDA’s in control”

“They sign off on these things”

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

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

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

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

“That’s important”

“That that that’s really important

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

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

“And that’s important”

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

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

“Gorski has made it abundantly clear”

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

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

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

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

You know

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

“Send me that”

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

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

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

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

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

Bob, who approves “Accelerated Approval” ?

1. FDA ?

2. A peer-reviewed scientific journal ?

3. The Skeptics™ ?

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

Click to access PressRelease_12022008_BZYR(2).pdf

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

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

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

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

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

Uhhh

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

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

(Freudian sarcasm slip)

I decided to take the position of being a Skeptic Skeptic

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

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

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

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

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

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

Uhmmm, and that’s gone nowhere

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

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

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

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

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

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

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

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

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

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

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

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

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

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

And they had 2, 2 patients that were dealt with

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

I’m sure that they’re tired of that

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

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

I think
——————————————————————

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

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

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

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

Could you send me that link, to that publication

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

Uhm

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

So, just think

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(Clarification: 1997)

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

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

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

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

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

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

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

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

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

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

This is really important though

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Uhmmm, hi everyone

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

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

What was their experience, you know ?

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

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

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

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

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

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

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

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

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

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

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

(Clarification: 7)

And see the same MRI’s and scans, etcetera

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

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

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

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

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

Let me

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

That turns his claims into something that’s unfalsifiable

If I could give you an example of what unfalsifiable is

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

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

Well, I don’t see anything

Well it’s an invisible dragon

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

Well, it’s incorporeal

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

Well it’s heatless flame that it breathes

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

And, oh no it’s ah it’s floating

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

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

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

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

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

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

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

So what’s the hold-up ?

I mean, hopefully they’ve done an autopsy

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

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

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

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

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

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

Um

Hold on a sec

She is a cute kid though

Um, alright

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

They were delighted

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

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

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

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

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

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

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

Um, and that was a

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

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

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

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

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

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

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

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

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

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

Well, okay

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

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

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

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

That’s pretty basic

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

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

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

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

You’re you’re you’re assuming that

You’re assuming that

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

Um, this, what would, what would convince you that you’re wrong
——————————————————————
The FDA not giving him phase 3 approval [12], the FDA not giving him ODD designation [10]
——————————————————————
So you’re saying because the Orphan Drug Designation and the face that there’s a phase 3, therefor it works ?
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And showing that, and showing the FDA that there’s evidence of effectiveness [11]
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So what you’re saying is there’s nothing that would convince you now, that it doesn’t work
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Not until the FDA says it doesn’t work
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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
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Well they seem to be doing a good job of it
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1:03:00
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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
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Well I’m sure, I’m sure they wouldn’t have done things if they didn’t see some evidence that it was working
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Um, I don’t know if you’ve read Jaffe’s book
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No I haven’t read it [44]
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There seems to have been a lot going on there you really should look at it because it’s it’s it’s kind of revealing

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

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

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

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

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

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

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

So the FDA is protecting him, uh from outside scrutiny

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

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

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

Um, definitely look at that

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

That comes across very clearly

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

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

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

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

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

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

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

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

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

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

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

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

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