All’s fair in Drugs and War

(4/1998 – 8/2003)
United States alleges GSK participated in

misleading medical journal article that misreported that clinical trial of drug demonstrated efficacy in treatment when study failed to demonstrate efficacy
At same time, United States alleges, GSK didn’t make available data from 2 other studies in which drug also failed to demonstrate efficacy
(2001 – 2007)
United States alleges GSK failed to include certain safety data about drug in reports to FDA meant to allow FDA to determine if drug continues to be safe for approved indications and to spot drug safety trends
missing information included data regarding certain post-marketing studies
data regarding 2 studies undertaken in response to European regulators’ concerns about safety of drug
United States alleges GSK stated drug had positive cholesterol profile despite having no well-controlled studies to support that message

Johnson & Johnson (J&J) and subsidiaries, Janssen Pharmaceuticals Inc. and Scios Inc.
Janssen Pharmaceutica Products, L.P.
$2.2 BILLION +
11/4/2013, Monday
Johnson & Johnson (J&J) and Janssen
complaint alleges J&J and Janssen were aware drug posed serious health risks, but companies downplayed these risks
For example, when J&J study of drug showed significant risk of strokes and other adverse events in patients, complaint alleges Janssen combined study data with other studies to make it appear there was lower overall risk of adverse events
year after J&J received results of 2nd study confirming increased safety risk for patients taking drug, but hadn’t published data, one physician who worked on study cautioned Janssen
“[a]t this point, so long after [the study] has been completedwe must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”
complaint alleges Janssen knew patients taking drug had increased risk, but nonetheless promoted drug as “uncompromised by safety concerns
When Janssen received initial results of studies indicating drug posed same risk as other antipsychotics, complaint alleges company retained outside consultants to re-analyze study results and ultimately published articles stating drug was actually associated with lower risk
J&J and another of its subsidiaries, Scios Inc.
8/2001 – FDA approved drug to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity
approval based on study involving hospitalized patients experiencing severe heart failure who received infusions of drug over average 36-hour period
complaint alleged Scios had no sound scientific evidence supporting medical necessity of outpatient infusions and misleadingly used small pilot study to encourage serial outpatient use of drug

Abbott Laboratories Inc.
5/7/2012, Monday
(2001 – 2006)
company marketed drug in combination with atypical antipsychotic drugs even after its clinical trials failed to demonstrate adding drug was any more effective than atypical antipsychotic alone for that use
1999 – forced to discontinue clinical trial of drug due to increased incidence of adverse events, including
experienced by study participants administered drug
funded 2 studies of use of drug
both failed to meet main goals established for the study
When 2nd study failed to show statistically significant treatment difference between antipsychotic drugs used in combination with drug and antipsychotic drugs alone, waited nearly 2 years to notify sales force about study results and another 2 years to publish results

AstraZeneca LP / AstraZeneca Pharmaceuticals LP
4/27/2010, Tuesday
engaged doctors to conduct studies on unapproved uses of drug
recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies doctors in question didn’t conduct
then used

as basis for promotional messages about unapproved uses of drug
11/26/2013 – United States Department of Justice (DOJ) versus BIG Pharma: BIG Pharma fought the law, and the law won ?:

Pete Cohen chats with Richard A. Jaffe, Esq.

4/2012Pete Cohen chats with Rick Jaffe
(33:59) 11/9/2012
Richard A. Jaffe, Esq.
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 ?
Even charlatans have testimony
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


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


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


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


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 ?

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


and you could just see quite clearly he was very uncomfortable


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 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 ?



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 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



The stuff with the, this kid, this blogger



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
So, that’s what I call, the church of medical orthodoxy
So, that’s what I call

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


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 ?

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

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

Oh really ?

I looked after him when he came over

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


Critiquing: Amelia’s family ‘mislead by cancer clinic’

6/5/2013 – This article was published By Getreading [1]

“A family who sent their terminally ill daughter to the US for experimental treatment said the clinic misled them about her chances of survival

“The parents of Pride of Reading Child of Courage winner, four-year-old Amelia Saunders who died in January, say they were told she had a 54 per cent chance of survival with the clinical trial in Houston, Texas

“However mum Chantal Saunders, 36, believes the actual figure was just one per cent
Based on what ?
“A BBC Panorama investigation shown on Monday questioned whether the Burzynski Clinic was “selling hope” to families
Aren’t all cancer treatments “selling hope” ?
“In it, Mrs Saunders said:”

“I think that’s wrong” [54 per cent figure]

“I think that’s a complete lie”

“I think one per cent is a more accurate figure.”
Based on what ?
“Dad Richard, 35, says he has only found two patients of Dr Stanislaw Burzynski with the same rare brain tumour as Amelia who survived long-term”

“Mr Saunders, from Lower Earley, said:”

“It didn’t work for Amelia but we absolutely know it works for other people.”

“It’s hard to believe it works for Amelia’s tumour type and that’s what we have found tricky”

“I’ve had all sorts of excuses from them as to why they won’t release data on how many patients they treat and the outcomes”

“I think the figures Panorama were given show there was 700-odd patients they treated and something like 15 per cent survived over five years
Panorama’s figures were:

“They say 776 patients with brain tumours were treated in trials before 2008.”

“And that 15.5% had survived more than five years, which compares favourably to other treatments.” [2]
“If you look at all brain tumours that’s almost identical to any other treatment”
Based on what ?
“If you look at Amelia’s tumour alone you’re looking at almost zero per cent.”

Amelia was diagnosed with a rare tumour on her brain stem in February last year

“Her devastated family was told by doctors there was no treatment available in Britain”

“After finding out about Burzynski’s clinical trial, which has been running for 20 years, Amelia’s family decided to raise the money needed for the ‘antineoplaston’ treatment – a staggering £250,000 – in just a few weeks through donations”

Mrs Saunders, who also has two-year-old daughter Charlotte, said:”

“He was giving us more hope than I think realistically there was”
Based on what ?
Mr Saunders added:”

“We find it very hard to believe the treatment did nothing”

“We did no chemotherapy with her”

“To keep it stable for 11 months is incredible in itself, but how do we prove that?”

“We can’t.”
Why not ?

Were there not scans ?
“In November last year Dr Burzynski told the family a new scan showed Amelia’s tumour was breaking down

UK doctors at Great Ormond Street Hospital in London said it actually showed the tumour was continuing to grow
Based on what ?

Great Ormond Street Hospital having 36 years of experience treating patients with antineoplastons ?
“The family decided to stop the Burzynski treatment a few weeks later”
Based on what ?
“Although the family now has doubts over Burzynski’s success rate, Richard says they have spoken to others who have been helped by the drug”
“The family now has doubts over Burzynski’s success rate” ?

What was all this, then ?

a) “A family who sent their terminally ill daughter to the US for experimental treatment said the clinic misled them about her chances of survival

b) “However mum Chantal Saunders, 36, believes the actual figure was just one per cent

c) “I think that’s wrong” [54 per cent figure]

“I think that’s a complete lie”

d) “I think one per cent is a more accurate figure.”

e) “He was giving us more hope than I think realistically there was”
“He said:”

“We asked repeatedly throughout the time Amelia was under treatment for evidence to back up his claims, and he at no point produced this”

“We found patients ourselves through Facebook, forums, email and word of mouth”

“We want everyone to know that there are people who are living proof that the treatment works – but it just didn’t for our little girl”

“We just wish Dr Burzynski would speak the truth, and release proper, tangible results.”
So, you wanted him to “release proper, tangible results” before the clinical trials were finished ?
“The Saunders family have donated the rest of the money raised for Amelia to cancer research and other charities”

“This included £50,000 to a cancer treatment research team at the University of Nottingham

“Its Professor Richard Grundy said it was “unethical” for Dr Burzynski not to publish results from his trial
So, you wanted him to “publish results from his trial” before the clinical trial was finished ?
“Unfortunately the results from Dr Burzynski’s clinic are not published in any form that’s acceptable to the scientific community,” he said”
So a donation of £50,000 was made, which included to a cancer treatment research team at the University of Nottingham, where Professor Richard Grundy; who exhibits NO knowledge of antineoplastons in this article, is

How “convenient” for him and the University

In my opinion,’ it is “unethical” for Professor Grundy to NOT share his findings re Dr. Burzynski’s 2003-2010 phase 2 clinical trial preliminary reports [3]

He reminds of the situation that Burzynski found himself in when he relates that clinical investigators decided to change the protocol without his approval on a clinical trial of antineoplastons

Seriously, who in their right mind would ignore the input of the inventor and developer of a medicine with close to 20 years of clinical experience, and think they know more than that person ? [4]
[1] – Reading Post, Amelia’s family ‘mislead by cancer clinic’, By Getreading | 5 Jun 2013 07:59
[2] – 8/4/2013 – Critiquing Dr David H. “Orac” Gorski, M.D., Ph.D, LIAR: Stanislaw Burzynski versus the BBC:
[3] – 9/22/2013 – Critiquing Wikipedia: Burzynski Clinic – 2013 BBC documentary, Curing cancer or ‘selling hope’ to the vulnerable?;
[4] – Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet “fact sheet”:

Critiquing Wikipedia: Burzynski Clinic – 2013 BBC documentary, Curing cancer or ‘selling hope’ to the vulnerable?

Wikipedia must be too busy accusing me of using multiple Internet I.P. addresses to try and change every wiki article under the sun, instead of keeping their Burzynski article up-to-date

I await the in-depth analysis which breaks down my blog, Twitter, and Internet activity, showing that it was humanly possible for me to do all that has been claimed

But then again, maybe I’m NOT human !


Is that you HAL ?

Anywho, WP took a crack at addressing the British Broadcasting Corporation’s (BBC) Panorama documentary [1]

I did some critiques on the documentary article, documentary, and WP’s “credible source,” Dr. David H. Orac … Gorski [2-4]

“Burzynski exploits a legal loophole”by treating patients” with antineoplastons do so as part of a clinical trial, so the drug does not need a licence” for twenty years.” [66]

“Legal loophole” ?

Really ??

Not so much

It’s the law

“The Skeptics™” have had years to get it changed in Congress if it were a “legal loophole”

“According to Watford Observer, the mother of Luna Petagine, a young girl with a brain tumor, “cast doubt” on Burzynski’s “expensive treatment.” [67]

“Expensive treatment” ?

Based on what objective criteria ? [5-6]

The Reading Post said, the Panorama investigation shown on Monday questioned whether the Burzynski Clinic was ‘selling hope’to families” which doubted the statistics provided by the Burzynski Clinic. [68]

Based on what objective criteria ?

“They say 776 patients with brain tumours were treated in trials before 2008.”

“And that 15.5% had survived more than five years, which compares favourably to other treatments.” [6] (see #13)

Where’s Wikipedia’s survival rates for:

a) Chemotherapy

b) Radiation Therapy

c) Radiotherapy

d) Other

and their comparison of possible adverse effects of chemotherapy, radiation therapy, radiotherapy, other, compared to antineoplastons ?

The issues I had with the documentary were:

1. “The report includes interviews with experts like Professor Richard Grundy of Nottingham Children’s Hospital”

“Prof Richard Grundy treats children with cancer, and runs one of the UK’s biggest research projects into brain tumours.”

“He says it is “unethical” for Dr Burzynski not to share his findings:”

In my ‘opinion,’ it is “unethical” for Professor Grundy to NOT share his findings re Dr. Burzynski’s 2003-2010 phase 2 clinical trial preliminary reports [7]

2. “Unfortunately the results from Dr Burzynski’s clinic are not published in any form that’s acceptable to the scientific community.””

Explain [7]

3. Dr Jeanine Graf

“She sometimes treats patients from the Burzynski Clinic who have become critically ill, but she has never known any of them survive.”

How many patients ?

Richard Bilton asked for numbers from Burzynski, so he should be consistent and have asked Dr. Graf the same question

4. “He must believe in what he’s doing, but I have not been convinced by the existing scientific literature that his therapy has any efficacy.”

Where is Dr. Graf’s “in-depth” review of Dr. Burzynski’s above-listed publications ? [7]
[1] – Wikipedia: Burzynski Clinic – Legal Issues: 2013 BBC documentary, Curing cancer or ‘selling hope’ to the vulnerable?
[2] – 6/4/2013 – The British are Coming, The British are Coming: Critiquing
“Curing cancer or ‘selling hope’ to the vulnerable?”

[3] – 6/7/2013 – IT MAY NOT BE SCIENCE: Critiquing “Curing cancer or ‘selling hope’ to the vulnerable?”:
[4] – 8/4/2013 – Critiquing Dr David H. “Orac”
Gorski, M.D., Ph.D, LIAR: Stanislaw Burzynski versus the BBC:

[66] – Richard Bilton

there for posterity on YouTube
[67] – Watford Observer
[5] – 4/25/2013 – Burzynski: Costs of Cancer treatments:
[6] – 7/18/2013 – Critiquing: In which the latest movie about Stanislaw Burzynski “cancer cure” is reviewed…with Insolence:
See #10
[68] – Reading Post
[7] – 8/7/2013 – Burzynski: Phase II Clinical Trials Preliminary Reports:

[24] – 1995 (10/27/1995) – Burzynski to Dr. Richard Klausner (7 pgs.)

This page is linked to:
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
[24] – 1995 (10/27/1995) – Burzynski 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH)

I was shocked to read the Cancernet “fact sheet” the NCI has been distributing about the cancellation of the clinical trials of antineoplastons, the anti-cancer drugs I discovered and developed

I find it scandalous that a government agency is putting out a public document containing such blatantly false information

Let me remind you that the only reason the clinical trials of antineoplastons were stopped is that NCI would not conduct them as per our written agreement

NCI’s “fact sheet” tries to obscure that simple fact with misinformation such as the following:

“In 1991, a “best case series” review was conducted by the National Cancer Institute (NCI) to evaluate clinical response in a group of patients treated at Dr. Burzynski’s Houston facility

For this review, Dr. Burzynski selected from his entire clinical experience 7 brain tumor patients whom he felt had a beneficial effect from antineoplastons.”

This misstatement is obviously calculated to make the reader think that in my entire clinical experience I have had only 7 patients who benefitted from antineoplaston treatment, which is wildly untrue

In fact, I prepared not 7, but dozens of cases for the NCI reviewers

As you must know, the reviewers were able to spend just one day at the clinic–enough time to review only 7 cases

Cancernet then compounds that misstatement with the following:

“This series did not constitute a formal clinical trial, since it was a retrospective review of medical records, did not include all available information, and included only cases selected by Dr. Burzynski” (my italics)

To the contrary, the patient medical records that NCI scientists reviewed were exhaustive and did contain “all available patient information.”

In fact, Michael Hawkins, M.D., leader of the site visit team, specifically complimented me on how complete and well-organized they were

The next misstatement is the following:

“The reviewers of this series determined that there was presumptive evidence of antitumor activity . . .”

Pg. 2

Now that the NCI’s Cancer Therapy Evaluation Program (CTEP) is under fire for misconduct in these clinical trials, it is rewriting history

The statement of the NCI scientists who actually reviewed patient records was quite different from the above

Their report (minutes of Decision Network committee meeting enclosed) stated that “The site visit team determined that antitumor activity was documented in the best case series and that the conduct of Phase II trials was indicated to determine the response rate” (my italics)

In other words, according to the site visit team, there was no question that the treatment worked in the cases reviewed

All that remained to be determined were the numerator and the denominator

Even the NCI’s own previous “fact sheet” on antineoplastons, dated 2/17/1994, (enclosed), states that

“The NCI reviewed 7 cases of patients with primary brain tumors that were treated by Dr. Burzynski with antineoplastons and concluded that antitumor responses occurred” (my italics)

But by far the most outrageous misstatement is the following:

“On 8/18/1995, the studies were closed because a consensus could not be reached with Dr. Burzynski on the proposed changes to the protocol to increase accrual, and there was no hope of completing the studies in a timely manner.”

The NCI never made any effort to “reach a consensus.”

Instead, it simply violated the written protocol we had agreed upon

Without informing me, NCI changed the rules to allow patients with any size or number of tumors, low performance scores, and spinal cord metastases

in other words, NCI was accepting patients whose brains and spinal cords were literally consumed by large malignant tumors–patients so advanced as to have no chance whatsoever

When I found out and insisted that NCI either conduct the study as agreed or inform patients that I felt it was conducting the study improperly, NCI cancelled it

The above is all well documented

While we were still in the negotiating stages, Michael Friedman, M.D. of the NCI wrote me a letter dated 11/2/1993 (enclosed) “. . . we will accede to all the modifications that you have stipulated.”

Dr. Friedman specifically agreed to exclude patients with:

* tumors larger than 5 cm (2 inches)
* multiple tumors
* metastases to spinal cord
* Karnofsky performance scores less than 70%

Based on Dr. Friedman’s written assurance that NCI would honor this exclusion criteria, I provided NCI with a large quantity of antineoplastons, and the clinical trial began

on 3/23/1994, Mario Sznol, M.D., of NCI wrote me proposing that NCI drop the exclusion for multiple tumors and spinal cord metastases, increase the maximum tumor size from 5 cm to 8 cm, and lower the Karnofsky score from 70 to 60 (enclosed)

in a response dated 4/19/1994 (enclosed), I wrote back that I would be glad to help NCI design a separate trial for such advanced patients, using a more aggressive dosage schedule

But I made it clear that it would be unethical to use the current dosage schedule on such patients since my experience had shown that such patients do not respond well to it

Pg. 3

As proof , I pointed out that in the NCI’s own review of patients treated with antineoplastons, the only ones who had less than 50% tumor shrinkage were exactly those with tumors greater than 5 cm

I did not hear back from NCI and assumed the matter had been dropped

Nearly one year later–in 3/1995–I learned that NCI had made all the changes to which I had objected

In fact, NCI went even further

Rather than raising the maximum tumor size from 5 to 8 cm as the NCI earlier suggested, it began accepting patients with any size tumor

I insisted that NCI either honor our agreement or change the Informed Consent statement (which patients must read and sign) to reflect the fact that I, the drug’s discoverer and developer, felt that the treatment was unlikely to be effective in such advanced patients in the doses being used

Rather than honor it’s commitment to conduct the study as agreed, NCI cancelled it

I find it particularly curious that now neither NCI nor Memorial Sloan-Kettering Cancer Center (MSK) will take responsibility for changing the exclusion criteria, and are instead pointing fingers at each other

in his letter of 4/3/1995 (enclosed), Dr. Sznol repeatedly refers to the “revised” eligibility criteria proposed by the [Memorial Sloan-Kettering] investigators” (my italics)

But, in a letter to John Lewis, M.D., of Memorial Sloan-Kettering’s Institutional Review Board dated 1/31/1995 (enclosed), the Chief Investigator, MSK’s Mark Malkin, M.D., writes that

“Further amendments, as described below, have been made at the request of NCI” (my italics)

If the changes to the protocol are as the NCI would have the world believe, why is everyone connected to them scurrying to disavow responsibility?

An even more serious matter is what appears to be the investigator’s relentless violations of the treatment protocol

Looking at the treatment summaries compiled by Theradex Corporation, the medical reporting company hired by NCI to compile and tabulate patient treatment data, it would appear that investigators violated the agreed-upon protocol in every patient treated

Apparent violations include the removal of patients from treatment who had no tumor growth (including one patient who, during subsequent surgery, was found to have no cancer cells remaining), and the removal of a patient for “skin reactions” caused not by antineoplastons, but by another drug patient was receiving, DPH

This is clear due to the fact that the patient’s skin condition worsened when he was taken off antineoplastons

It improved only after DPH was discontinued

The summaries provided by Theradex are somewhat sketchy, so I asked to review the complete records of patients tested–which Dr. Friedman had specifically promised to provide

NIH lawyer Robert Lanman replied in a letter dated 8/23/1995 (enclosed) that the NCI did not have any such records

In fact, several patients were treated at NCI and of course NCI has their complete medical records

When I demonstrated this by sending Mr. Lanman copies of patient records obtained by a patient’s family from NCI, he admitted in fact NCI does have patient records, but refused to release them

And he disregarded his own misstatements of fact by saying that

“Given that you apparently have already obtained at least one of the patient’s records, we fail to understand why you are perusing this matter” (letter from Robert Lanman dated 10/5/1995 enclosed)

Mr. Lanman also claims that NCI has “no such commitment” to release medical records of patients treated with antineoplastons

And Dr. Friedman, in a letter dated 9/19/1995 (enclosed), writes that Dr. Burzynski’s request for “detailed records” has been satisfied by the sketchy Theradex treatment summaries

Pg. 4

Both these statements directly contradict Dr. Friedman’s letter of 11/2/1993 (enclosed), in which he promises that

“In accordance with your letter, we will arrange a review of data after accrual of the 1st 5-6 patients, which should occur 6 months after the study has been initiated

This should be sufficient to assure that the conduct of the study is satisfactory

The Theradex database is also available . . .” (my italics)

In other words, Dr. Friedman promised to provide me with patient medical records, recognizing that the Theradex summaries are something quite separate

In that same 9/19/1995 letter, Dr. Friedman writes that

“We have no individual patient records in our possession in addition to the Theradex reports.”

Either he is deliberately misstating the facts, or he is out of touch with the Cancer Therapy Evaluation Program that he runs

Dr. Klausner, I request that you immediately withdraw the “fact sheet” the NCI is distributing which contains numerous and outrageous misstatements and distortion of fact

Thank you for your attention to this matter



3+ pgs cc:




1993 (11/2/1993) – Dr. Michael Friedman to Burzynski
1994 (2/17/1994) – NCI “fact sheet”
1994 (3/23/1994) – Dr. Mario Sznol to Burzynski
1994 (4/19/1994) – Burzynski to Dr. Mario Sznol
1995 (1/31/1995) – Dr. John L. Lewis
1995 (4/3/1995) – Dr. Mario Sznol to Burzynski
1995 (8/18/1995) –
1995 (8/23/1995) – Robert B. Lanman to Burzynski
1995 (9/19/1995) – Dr. Michael A. Friedman to Burzynski
1995 (10/5/1995) – Robert B. Lanman to Burzynski

[6] – 1991 (12/2/1991) – NCI Decision Network Report on Antineoplastons

This page is linked to:
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
[6] – 1991 (12/2/91) – NCI Decision Network Report on Antineoplastons [5 pgs. – Pg. 11] guidelines of the NCI’s Decision Network
Minutes of the Meeting of the NCI’s Decision Network Regarding Antineoplastons A10 and AS2-1 12/2/1991

Pg. 11 (2nd pg.)

B. Candidates for DN Stage IV
Antineoplastons A10 and AS2-1, NSCs 648539D and 620261/#2

The antineoplastons have been considered as unconventional manner of cancer treatment because there have been very few independent interpretable scientific data on their potential clinical efficacy

Based on a recent report of observed responses in brain cancer patients treated with antineoplastons at the Burzynski Research Institute (founded by Dr. S.R. Burzynski) in Houston, Texas, the Cancer Therapy Evaluation Program (CTEP) conducted a site visit to review a “best case” series of clinical responses to antineoplastons in the treatment of brain tumors at the Institute

This case series does not constitute a clinical trial; the cases were selected on the basis of positive response from many different studies of antineoplaston treatment at the Institute

The site visit team determined that antitumor activity was documented in this best case series and that the conduct of Phase II trials were indicated to determine the response rate

The antineoplastons were presented as DN Stage IV candidates for the conduct of Phase II trials in glioblastoma multiforme, anaplastic astrocytoma, pediatric brain tumors, and low-grade gliomas, to confirm the observation of brain tumors at the Burzynski Institute

It was proposed that the same treatment regimen as that used at the Institute would be used in the Phase II trials

A decision regarding subsequent trials (e.g., other tumors, additional Phase I development, Phase III trials in brain tumors) would be deferred until the results of these initial trials were known

If the antineoplastons are approved for Phase II study, Dr. Burzynski will provide supplies of the materials for the clinical trials to the NCI free of charge

Dr. Burzynski presented background on antineoplaston research

His research is based on the hypothesis that antineoplastons are components of a biochemical defense system against cancer

The antineoplastons are medium and small peptides and amino acid derivatives that form the defense against cancer by inducing differentiation in neoplastic cells
Initial study on antineoplastons was concentrated on isolation of peptides in blood and urine of healthy people

Pg. 12 (2nd pg.)

Two main groups of antineoplastons have been isolated

Pg. 13 (3rd pg.)
Pg. 14 (4th pg.)

Decision: Antineoplastons A10 (NSC 648539D) and AS2-1 (NSC 620261/#2) passed DN Stage IV






1991 (12/2/1991) – guidelines of the NCI’s Decision Network [5 pgs.] [8]