Stanislaw Rajmund Burzynski, Stanislaw R. Burzynski, Stanislaw Burzynski, Stan R. Burzynski, Stan Burzynski, S. R. BURZYNSKI, S. Burzynski, Arthur Burzynski, Hippocrates Hypocrite Hypocrites Critic Critics Critical HipoCritical
I’ve made no secret of how much I dispute David H. Gorski, a la “Orac”, the “self-proclaimed”brain cancer doctor and brain cancer researcher who has been treating readers with an unproven, unapproved, NOT ordinarychemotherapeutic agent since Jesus just left Chicago, bound for Nawlins, seemingly Elaphe longissimaslithering around, under, over, and past all attempts to intestate him and shut him up
Along the way, GorskGeek has become a hero to the cancer hackery industry, touted as the man who can cure incurable insomnia that science-based medicine can’t, even though his treatment, insolence, allegedly pop tarts isolated from bloopers and Uranus that normally keep insomnia in check in healthy people, are by any reasonable definition NOT ordinary chemotherapy
Indeed, they are toxic, with a number of side effects reported, the most common and dangerous of which being life-threatening hyperactivity (elevated sugar levels in the blood)
All you have to do is to type GorsGeek’s name into the search box of this blog, and you’ll find copious documentation of the abuses of patience, science, and critical trials perpetrated by “Orac” and the cult of impersonality that has evolved around him
He’s even acquired his very own film perpougendist, a credulous fellow named Bob Blaskiewicz, who has made 2 astoundingly bad hackumentaries that are nothing more than unabashed hagiographies of the brave maverick doctor curing insolence where no one else can
They’re chock full of misinformation, pseudononsense, spin, and obvious emotional manipulation, and the 2nd one, at least, was very popular
For the longest time, I’ve been hoping that major mainstream news organizations would take this story on
—————————————————————— GorskGeekclaims:
“Now, thanks to Liz Szabo at USA Today, we know from her article Doctor accused of selling false hope to families [1]:
“Yet hypernatremia is one of antineoplastons’ most common side effects, known to doctors for two decades”
—————————————————————— GorskGeek, of course, does NOT care to mention the 2 hypernatremia studies that I listed in the 2nd of my 3 critiques on USA TODAY’s“hatchet job” of Burzynski[2], because, as he accuses others:
THEY DO NOT FIT HIS NARRATIVE
—————————————————————— GorskGeek continues:
—————————————————————— “showed a blood sodium level of 205 millimoles per liter, a level that is typically fatal“
“I was astounded to see that number“
“I’ve never, ever seen a sodium level that high“
“Typically, normal is typically between 135 and 145 mEq/L, with slight variations of that range depending on the lab”
“Burzynski’s excuse, which I’ve heard at various times as being due to an “improper blood draw” or as described above, is purest nonsense”
“Unless the technician spiked Josia’s sample with 3% saline or something like that, there’s no way to get the leve that high”
“Josia almost certainly died because of hypernatremia from antineoplaston therapy“
“To me, this is the biggest revelation of the story:”
“The story and identity of the child who was killed by Burzynski’s treatments“
——————————————————————
I did NOT know that GorskGeek was the Medical Examiner for the United States Food and Drug Administration
—————————————————————— GorskGeek is mistaken, as the “purest nonsense” is his nonsensical claim:
“I’ve never, ever seen a sodium level that high“
The reasonGorskGeek has:
“never, ever seen a sodium level that high”
is because he’s a “hack”, who’s more interested in churning out as many blogsplats as he can, rather than doing real“science-based medicine”research
As evidence of MY claim, I submit:
—————————————————————— 9/2004 – A Non-Fatal Case of Sodium Toxicity (Hypernatremia)
—————————————————————— “6 year old boy who was taken to the hospital following a seizure attack, and lab analyses revealed a serum sodium (Na+) levels of 234 mEq/L”
“A search of the boy’s house led to the discovery of rock salt in the cabinet and a container of table salt”
“Extrapolating from the serum sodium (Na+) level, it was estimated that the child had ingested approximately 4 tablespoons of rock salt, leading to the acute toxicity“
“A literature search revealed that the serum sodium (Na+) concentration in the present report was the highest documented level of sodium in a living person“
Non-Fatal 193-209 mEq/L have been reported previously [3]
——————————————————————
We also learn that—surprise! surprise!—GorskGeek is an enormous tool
(as opposed to having “an enormous tool” His cranium is too small to have “enormous tool”)
—————————————————————— GorskGeek then hacks:
—————————————————————— “Look at him dismiss his critics, particularly former patients, many of whom, let’s recall, have terminal cancer, many of whom are dead:”
“Burzynski dismisses criticism of his work, referring to his detractors as “hooligans” and “hired assassins.””
—————————————————————— GorskGeek, you are a “hooligan”, liar, lame, loser, et al.
—————————————————————— GorskGeek proceeds:
—————————————————————— “You know, whenever I hear Burzynski fans like Eric Merola accuse skeptics of attacking cancer patients, of accusing them of horrible things”
“I think I will throw this quote right back in their faces”
“Here’s Burzynski calling his patients prostitutes, thieves, and mafia bosses, and “not the greatest people in the world,” while accusing them of wanting to “extort money from us.””
—————————————————————— GorskGeek, LAME attempt at another LIE
Burzynski did NOT CALL his patients what YOU claim he called them
Let me repeat it for YOU, because I have the sneaking suspicion that YOU are “intellectually challenged”
BurzynskiSAID:
“We see patients from various walks of life”
“We see great people”
“We see crooks”
“We have prostitutes”
“We have thieves”
“We have mafia bosses”
“We have Secret Service agents”
“Many people are coming to us, OK?”
“Not all of them are the greatest people in the world”
—————————————————————— GorskGeek, just in case you did NOT learn this at the University of Michigan, there is a difference between SAYING“WE SEE” and / or “WE HAVE”, and CALLING someone something
Allow me to provide you with a great example
If I SAY that YOU are the BIGGEST POMPOUS ASS I’ve ever seen, and YOU are NOT a BIG POMPOUS ASS, then THAT is derogatory
However, if I CALL YOU the BIGGEST POMPOUS ASS that I have ever seen, because you really and truly are a BIG POMPOUS ASS; as you are, then THAT is NOT derogatory
—————————————————————— GorskGeek tries again:
—————————————————————— “Not surprisingly, he also liberally uses the Galileo gambit, but that’s not surprising, as he’s repeatedly made the hilariously arrogant and scientifically ignorant claim that he is a pioneer in genomic and personalized cancer therapy and that M.D. Anderson Cancer Center and other world-class cancer centers are “following his lead.””
“Indeed, he claimed to have invented the field 20 years ago”
“Sadly, his publication record does not support such grandiose claims“
—————————————————————— GorskGeek, how would you know ?
You proved that you weren’t smarter than a 5th grader when you could NOT find Burzynski’s1997 Antineoplastons, oncogenes and cancer [4]
—————————————————————— “Curious as to just what the heck Burzynski was talking about here, I searched PubMed for this alleged review article”
“I couldn’t find it on PubMed“
“Perhaps Burzynski proposed this “revolutionary” new idea in a peer-reviewed article that’s not indexed in PubMed, but if he did I couldn’t find it using Google and Google Scholar“[5]
So why should ANYONE believe that you were able to locate the rest of his publications
and review all of them?
Now THAT would be a “grandiose claim”
—————————————————————— GorskGeek was also the village “idiot savant” (minus the “savant”) who face planted:
“how Burzynski never explains which genes are targeted by antineoplastons … “[6]
GorskGeek must have fumed for days when he found I “fact-checked” his fluff and found it false: [7-8]
—————————————————————— GorskGeekhopes to wreak havoc when he harrumphs:
—————————————————————— “For instance, experts are saying the same things I’ve been saying for a couple of years now about Burzynski’s anecdotes of “miracle cures,” such as Hannah Bradley and Laura Hymas”
“The reasons for these anecdotes include:”
“Burzynski often relies on anecdotes, which don’t tell the full story”
“Burzynski’s therapies are unproven“
“Burzynski’s patients may have been misdiagnosed“
“Burzynski’s patients may have been cured by previous therapy“
“There’s a reason why I’ve spent so much time deconstructing Burzynski anecdotes, and it’s for all of those reasons plus that anecdotes are often interpreted incorrectly by patients without medical training”
“Even doctors who are not oncologists sometimes interpret such anecdotes incorrectly to indicate that the cancer therapy chosen is the therapy that cured the patient“
“It’s not just Burzynski patient anecdotes, but it’s any cancer cure anecdote“
“That’s why clinical trials are necessary to differentiate all these confounding effects from actual effects due to the treatment”
—————————————————————— GorskiGeek displays what an abject #FAIL he is, as the question he should be asking is:
Why is the Food and Drug Administration FORCING patients to #FAIL conventional treatments; such as surgery, chemotherapy, and radiation therapy, before being allowed to utilize antineoplaston therapy ?
If the FDA was NOT doing this, then GorskGeek and the “so-called experts” would NOT have this crutch to fall back on
GorskGeek, please list all the other phase II clinical trials where the F.D.A. has done this, and please also explain what would you do if the FDA did this to YOUR clinical trials ?
I know this might require some “Grapefruits” on your part, but do try and see if you can find yours in order to pull this off, if you’re NOT the coward I think you are
And when you’re done with that, please try to explain away the case of Jessica Ressel-Doeden
GorskGeekwinds up for the pitch of bullshit
He ratchets back his right arm and rockets it right into his rectum, reaches ’round and pulls out this righteousness:
—————————————————————— “Not coincidentally, Hannah Bradley had surgery, chemotherapy, and radiation, and Laura Hymas had radiation and chemotherapy”
GorskGeek, Hannah Bradley NEVER had chemotherapy, unless you are now going to claim that by “chemotherapy” you meant antineoplastons [9]
Hannah specifically mentioned:
“Chemotherapy also mentioned but not strong enough for that” [10]
—————————————————————— GorskGeek:
“Even doctors who are not oncologists sometimes interpret such anecdotes incorrectly” ?
I think you meant, even breast cancer oncologist specialists who are NOT brain cancer oncology specialists interpret incorrectly, you JackASS
====================================== [4] – 1997 – Burzynski. S.R. Antineoplastons. oncogenes and cancer. Anti-Aging Medical Therapeutics, Vol.1. Klatz RM.
Goldman R. (Ed). Health Quest Publication 1997; Marina del Rey, CA. USA
Pg. 24
——————————————————————
====================================== 4/2012 – Pete 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 ?
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 Rockefellerconspiracy
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
======================================
Musings on the intersection of Articles, Bias, and Censorship
(The Big 3: A.B.C.)
4/19/2013 @ 9:43PM
A Film Producer, A Cancer Doctor, And Their Critics
Allen Jones 1 day ago
“Interesting article.”
“Since there are two competing sides here I decided to do a bit of research on Burzynski and his treatment.”
“Success seems to be defined in terms of anecdotes only.”
“And after a continued search there seems to be just as many anecdotes of failures for this treatment.”
“Reading the website “the other Burzynski patient group” that outline all the heart wrenching failures of this treatment was difficult.”
“My conclusion is that this Burzynski is a quack of the lowest level.”
“Shameful!!!”
Allen Jones, I really can NOT adequately express how convincing your “alleged” “bit of research” sounds
Shameful!!!”???
claire G 1 day ago
@Guy Chapman,
(claire G, I really can NOT adequately express how convincing your use of @Guy Chapman is, considering as how “Guy Chapman” has gone by “guychapman” in all 18 of his “erudite” posts)
“It seems to me that actually the FDA are being very fair to Burzynski.”
claire G, please expand on how THIS is “the FDA” “being very fair to Burzynski.”
“Despite the massive problems with hsi institutional review board, and his abject failure to publish results, they continued to allow him to register new trials.”
claire G, please expand on:
“they continued to allow him to register new trials.”
Exactly WHEN did “they continued to allow him to register new trials” “[d]espite the massive problems with hsi institutional review board”?
Please advise WHERE
“his abject failure to publish results”
was a condition for him “to register new trials.”
“I can’t think of anyone else in that position”.”
“You are so right.”
claire G, “you are so right”
“I can’t think of anyone else in that position”.
Exactly HOW are you going to answer THOSE questions?
“That cracking sound you hear is the FDA bending over backwards to accommodate Burzynski!”
claire G, please explain exactly HOW was the FDA requiring radiation in the phase 3 clinical trial, bending over backwards to accommodate Burzynski!”
Securities and Exchange Commission (SEC) Form 10-Q for the quarterly period ended 5/31/2010:
1/13/2009 Company announced Company had reached an agreement with FDA for Company to move forward with pivotal Phase III clinical trial of combination Antineoplaston therapy plus radiation therapy in patients with newly diagnosed, diffuse, intrinsic brainstem gliomas (DBSG)
Agreement was made under FDA’s Special Protocol Assessment procedure, meaning design and planned analysis of Phase III study is acceptable to support regulatory submission seeking new drug approval
2/1/2010 Company entered into agreement with Cycle Solutions, Inc., dba ResearchPoint to initiate and manage pivotal Phase III clinical trial of combination Antineoplastons A10 and AS2-1 plus radiation therapy (RT) in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma
ResearchPoint is currently conducting feasibility assessment
ResearchPoint has secured interest and commitment from number of sites selected
Upon completion of assessment, randomized, international phase III study will commence”
Study’s objective is to compare overall survival of children with newly-diagnosed DBSG who receive combination Antineoplastons A10 and AS2-1 plus RT versus RT alone
” … only obstacles now are $300 million $s needed to pay for final phase of clinical testing-and FDA requiring children with inoperable brainstem glioma to also undergo radiation
treatment in Phase 3 trials, claiming it would be “unethical” not to do so”
“For all the whining and complaining by Burzynski fans that he’s been so hounded and mistreated by the FDA,”
Only the rich, powerful, and the affluent who are “in the know” can get it now (no longer in the USA).”
“Ha!”
“So what you mean then is that nothing has really changed?”
claire G, are you indicating that antineoplastons were NOT available in the USA?
“It was always only either the very wealthy or those who could scrap together the $200,00.00 from donations who could afford antineoplastons.”
claire G, are you indicating that EVERY antineoplaston patient has had to “SCRAP together the $200,00.00”?
“By not publishing his research so that it could be peer reviewed and approved by the FDA Burzynski assured that antineoplastons would not be covered by insurance.”
claire G, please provide your citation(s), reference(s), and / or link(s) which support your:
“By not publishing his research so that it could be peer reviewed and approved by the FDA
“The results of clinical trials are OFTEN published in peer-reviewed scientific journals”
” … WHETHER OR NOT the results are published in a peer-reviewed scientific journal … “ http://m.cancer.gov/topics/factsheets/clinical-trials This makes it clear that clinical trial results “are OFTEN” published, but sometimes they are “NOT” published “in a peer-reviewed scientific journal”
The Declaration of Helsinki doesn’t indicate WHEN results MUST be published
“If you were sitting on this effective cure for cancers that affect children especially, wouldn’t you want to do whatever it took to make it available to anyone who needed it?”
claire G, ask the FDA
“Isn’t that what an ethical, caring, humanitarian would do?”
claire G, I refer you to the above
Boris Ogon
“You are right now having a live “debate” in front of more than 10,000 people, … “
Peter Lipson, Contributor
Musings on the intersection of science, medicine, and culture
3,932 views
Not so much
Waiting for the 10,000
Peter Lipson, Contributor
Musings on the intersection of science, medicine, and culture
4/19/2013 @ 9:43PM
Peter Lipson: “Speech is best countered by more speech”
Musings on the intersection of Articles, Bias, and Censorship
(The Big 3: A.B.C.)
4/19/2013 @ 9:43PM
A Film Producer, A Cancer Doctor, And Their Critics
randy hinton 5 days ago
Hey Petey!
“I am ready to sit on a stage with Eric in front of a large crowd and debate this matter with you ANYTIME YOUR READY.”
Petey!, responds:
guychapman 5 days ago
(citing randy hinton 5 days ago)
“WHY DID 230 CHILDREN’S HOSPITAL’S TURN DOWN BURZYNSKI’S PHASE 3 BRAINSTEM GLIOMA TRIAL???”
“The answer is in your own post.”
“They were not convinced the treatment was likely to provide benefit, so why on earth would they subject children to the side effects, infection risk and other known problems with ANP treatment?”
“Unlike Burzynski, they seem to have followed the dictates of the Helsinki declaration.”
guychapman, HOW has Burzynski NOT “followed the dictates of the Helsinki declaration.”?
YOU remind me of this randy hinton comment:
“The hospital’s don’t seem to want to discuss this matter publically.”
And neither do YOU
Sharon Hill 5 days ago
“I am thrilled with this piece.”
“My website, Doubtful News, was also a target of the Burzynski PR machine when they tried to shut down critique and questioning.”
Sharon Hill, I’m “doubtful” your website was worth the trouble
But look on the bright side
You just got free “Pub” in a BIASED CENSORING publication
It’ll be something you can tell the grandkids about
“Very pleased that this part of the story is getting out.”
“The bottom line is, there would be no problems if the clinic just met the same standards expected from all clinics – you follow the federal and state rules and you have evidence to back up your claims.”
“The fact that they have to retaliate the way they do is GOOD evidence they have nothing better to show.”
Sharon Hill, and I see that:
“The fact that you have to retaliate the way you do is GOOD evidence you have nothing better to show.”
As in, NO “citation(s),” NO “reference(s),” and / or NO “link(s)” that support your claims
ovalwooki 5 days ago
“Mr. Burzynski is a fraud, a thief, and a scoundrel.”
ovalwooki, so, like YOU ?
“When people are at their lowest, facing death for themselves or a Loved one, he holds out a lie disguised as hope, takes every dime from them that he can, and in some cases even threatens with lawsuits the very people he’s just ripped off.”
ovalwooki, and we should just take your word for it, because, WHY?
“He threatens innocent people who call him out on his horrible record of successful ” cures “ .”
ovalwooki, WHAT is:
“his horrible record of successful ” cures“ ?
“As far as I know, he’s cured no one, ever, and there is no validity to him or his methods, at all.”
ovalwooki, exactly WHAT does:
“As far as I know”
MEAN ?
“He clearly defines what is most flawed with our system of healthcare, here in America.”
ovalwooki, “clearly defines what is most flawed with our system of” yellow journalism, here in America
randy hinton 5 days ago
“In the 1950’s, Congressman Charles Tobey enlisted Benedict Fitzgerald, an investigator for the Interstate Commerce Commission, to investigate allegations of conspiracy* and monopolistic practices on the part of orthodox medicine.”
“This came about as the result of the son of Senator Tobey who developed cancer and was given less than two years to live by orthodox medicine.”
“That is when he learned of alleged conspiratorial practices on the part of orthodox medicine.”
“The final report clearly indicated there was indeed a conspiracy to monopolize the medical and drug industry and to eliminate alternative options.”
guychapman 3 days ago
“That was 60 years ago.”
“And it was not adopted as generally plausible even then.”
guychapman, so, what has changed since then, because there are definitely still dissimulators like YOU?
“By peerless I mean risible, of course.”
guychapman, so, like your comments, right?
JGC2013 4 days ago
“It seems to me there are nly too possibilities here:”
JGC2013, “nly” ?
“1) Antineoplastons don’t work and after two decades and 60-plus uncompleted and unplublished ‘clinical trials’ Burzinsky is fully aware that there is no evidence antineoplastons showing they are effective at treating advanced cancers, but despite this continues to charge patients to receive antineoplaston treatment for financial gain.”
“Orac” and the “Oracolytes” Cult of Misinformation: https://stanislawrajmundburzynski.wordpress.com/2013/04/29/orac-and-the-oracolytes-cult-of-misinformation/
“Or 2) antineoplastons DO work, and Burzinsky does have clinical evidence demonstrating efficacybut rather than publish the results of trials (allowing independent oncologists can first confirm and then adopt antineoplatosn therapy) he’s chosen not to publish in order to maintain a lucrative monopoly on antineoplaston herapy, offering it only to the small subset of cancer patients who afford to pay exorbitant fees to be treated at his clinic and effectively denying millions of other cancer patients access to a cure for their cancer.”
By a curious coincidence, several senior figures in the pharmaceutical industry today gave evidence to the House of Commons Science and Technology Committee on the specific issue of publication before and after the event for clinical trials and data, and discuss the obligations of those conducting trials. http://www.parliamentlive.tv/Main/Player.aspx?meetingId=13017 (from approx. 18:44 for the directly relevant content)
guychapman, thank you for keeping us appraised of what’s going in the United Kingdom, home to Kings, Queens, Dukes, Dutchesses, Earls, Counts, Countesses, Knights, Dragons, Wizards, etc., and that fairyland you’re living in
"Figures as low as 70-odd percent and as high as 90+ percent."
guychapman, just in case you have NOT noticed, Burzynski is in the United States of America
“Nobody citing zero percent as being acceptable or desirable, oddly.”
guychapman, YOU have “zero percent” acceptability or desirability, oddly.
AstroturfWatch 4 days ago
“Hey Peter Lipson, while you were at the Cleveland Clinic, did you speak to Dr. Bruce Cohen, the director of Neuro-oncology?”
“Because he is in “Burzynski Part 1″ and was Paul Michaels neuro-oncologist and watch Paul’s brain tumor “disappear” (after previously telling Paul’s parents “this is the worst case we’ve ever seen”.”
“Dr. Cohen is in the “trailer #2″ from Burzynski, Part 1 also.”
“I think Bruce is still there, perhaps you need to give old Bruce Cohen a call ;)”
“Science does not work by assuming that single voices in the wilderness somehow counter the consensus view.”
“The consensus of informed opinion is that Burzynski’s treatment is unproven and not terribly likely to become proven, not least because his science appears incompetent.”
guychapman, are you indicating that Dr. Cohen is NOT competent, and misdiagnosed his patient?
Boris Ogon
“You are right now having a live “debate” in front of more than 10,000 people, … “
3,932 views
Not so much
Waiting for the 10,000
| 4/19/2013 @ 9:43PM
Peter Lipson: “Speech is best countered by more speech”
posted an article of a very dubious nature on Forbes (#Forbes), which censored (deleted) comments submitted and screen-captured as having been posted to the article comments section
What did Forbes do to rectify this embarrassing blunder?
Well, they did NOT do what Wikipedia is supposed to do (Do the RIGHT THING), they instead changed their comment acceptance function so that it now does NOT post the comments to the comment section; where they can be screen- saved to show that you submitted them, but now prevents the comments from being posted to the comments section before being reviewed by their censor(s)
I was able to submit comments and screen save them to show I submitted them, but the below, for example, was still censored
Thursday, 5/2/2013-ATTEMPT 1:
Didymus Thomas 30 minutes ago
Mr. Ogon, is this one of the Kurume, Japan case studies you were referring to?
Randomized Phase II Study of Hepatic Arterial Infusion with or without Antineoplastons as Adjuvant Therapy after Hepatectomy for liver Metastases from Colorectal Cancer. Annals of Oncology 2010;21:viii221
Reply
Didymus Thomas 20 minutes ago
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Didymus Thomas 4 hours ago
Mr. Ogon, you commented:
“One further has to take into account the fact that Scamley has been known to employ idiosyncratic definitions, such as classifying tumor *growth* as “STABLE DISEASE” for “less than 50% reduction in size but no more than 50% increase in size of the tumor mass, lasting for at least twelve weeks.””
FDA has advised:
5/2007 – “Guidance for Industry – Food and Drug Administration”
“Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics”
“”STABLE DISEASE should not be a component of ORR”
“STABLE DISEASE can reflect the natural history of disease””
(Pg. 10 of 22 = actual pg. 7 of PDF)
“…STABLE DISEASE can be more accurately assessed by TTP or PFS analysis (see below)”
“Also, STABLE DISEASE can be more accurately assessed by TTP or PFS analysis (see below)”
(Pg. 11 of 22 = actual pg. 8 of PDF)
“Time to Progression and Progression-Free Survival”
“TTP – Time to Progression”
“PFS – Progression-Free Survival”
“TTP and PFS have served as primary endpoints for drug approval”
(Pg. 11 of 22 = actual pg. 8 of PDF)
And in addition, the below 2005 non-Burzynski study also uses “STABLE DISEASE?”
Role of temozolomide after radiotherapy for newly diagnosed diffuse brainstem glioma in children
Results of a multiinstitutional study (SJHG-98)
Reply
Didymus Thomas 15 minutes ago
Mr. Chapman, you commented:
” … the failure to publish any usable results from any single trial is grossly unethical”
“ The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective” advises:
“[T]he emphasis in Phase 2 is on EFFECTIVENESS”
“This phase aims to obtain PRELIMINARY DATA on whether the drug works in people who have a certain disease or condition”
“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2″
“These studies gather more information about safety and EFFECTIVENESS, studying different populations and different dosages and using the drug in combination with other drugs”
Reply
Didymus Thomas 9 minutes ago
Securities and Exchange Commission (SEC) Form 10-Q for the quarterly period ended 5/31/2010 states:
1/13/2009 Company announced Company had reached an agreement with FDA for Company to move forward with pivotal Phase III clinical trial of combination Antineoplaston therapy plus radiation therapy in patients with newly diagnosed, diffuse, intrinsic brainstem gliomas (DBSG)
Agreement was made under FDA’s Special Protocol Assessment procedure, meaning design and planned analysis of Phase III study is acceptable to support regulatory submission seeking new drug approval
2/1/2010 Company entered into agreement with Cycle Solutions, Inc., dba ResearchPoint to initiate and manage pivotal Phase III clinical trial of combination Antineoplastons A10 and AS2-1 plus radiation therapy (RT) in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma
ResearchPoint is currently conducting feasibility assessment
ResearchPoint has secured interest and commitment from number of sites selected
Upon completion of assessment, randomized, international phase III study will commence
Study’s objective is to compare overall survival of children with newly-diagnosed DBSG who receive combination Antineoplastons A10 and AS2-1 plus RT versus RT alone
Reply
Didymus Thomas 1 minute ago
2003-2006 phase II clinical trial preliminary reports.
The co-authors might include an oncologist:
Drugs R D.
2003;4(2):91-101
2004;5(6):315-26
Integr Cancer Ther.
2005 Jun;4(2):168-77
2006 Mar;5(1):40-7
Friday, 5/3/2013-ATTEMPT 2
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Mr. Ogon, 5/2007 – “Guidance for Industry – Food and Drug Administration”
“Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics”
“Stable disease can reflect the natural history of disease”
“Also, stable disease can be more accurately assessed by TTP or PFS analysis”
“TTP – Time to Progression”
“PFS – Progression-Free Survival”
“TTP and PFS have served as primary endpoints for drug approval”
The below study also uses “stable disease”
Cancer. 2005 Jan 1;103(1):133-9 DOI: 10.1002/cncr.20741
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Mr. Ogon, 5/2007 – “Guidance for Industry – Food and Drug Administration, Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics:” “Stable disease can reflect the natural history of disease”
This study uses “stable disease:”. Cancer. 2005 Jan 1;103(1):133-9 DOI: 10.1002/cncr.20741
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Forbes posted the 1 below comment out of the above:
Didymus Thomas 3 days ago
Mr. Ogon, is this one of the Kurume, Japan case studies you were referring to?
Randomized Phase II Study of Hepatic Arterial Infusion with or without Antineoplastons as Adjuvant Therapy after Hepatectomy for liver Metastases from Colorectal Cancer. Annals of Oncology 2010;21:viii221
One would hope that Forbes would learn a lesson about censoring individual’s comments, but instead, it seems that they learned a lesson about how to block comments
Here is the BIAS exhibited by Forbes, as far as whose comments they did NOT “censor”
– = “The Skeptic” Critics
+ = Questioning “The Skeptic” Critics
– = 70
+ = 44
+ = 25 more
(pg. 1)
rjblaskiewicz – guychapman – Peter Lipson – rjblaskiewicz – Vered Yasur –
Angel of Life + rjblaskiewicz – guychapman – guychapman –
Krista Cashatt +
(pg. 2)
Boris Ogon –
junkeeroo + Boris Ogon –
Sarah
junkeeroo +
junkeeroo + Boris Ogon – rjblaskiewicz –
Kendra Sue Too + Boris Ogon –
(pg. 3)
junkeeroo + Boris Ogon –
junkeeroo + guychapman – FW –
Angel of Life + rjblaskiewicz –
randy hinton + Boris Ogon – rjblaskiewicz –
(pg. 4)
lilady – Vered Yasur –
junkeeroo +
Tina Patterson +
chriswinter + guychapman –
Angel of Life + Boris Ogon – JGC2013 – guychapman –
(pg. 5)
lilady –
Angel of Life + Boris Ogon – FW –
junkeeroo +
Angel of Life + Peter Lipson –
Angel of Life +
junkeeroo + Boris Ogon –
(pg. 6)
Paul Morgan – guychapman – JGC2013 –
junkeeroo + FW –
junkeeroo + rjblaskiewicz – FW –
Angel of Life +
Angel of Life +
(pg. 7)
Angel of Life + FW –
AstroturfWatch + FW –
junkeeroo +
junkeeroo +
Angel of Life + Peter Lipson –
AstroturfWatch +
AstroturfWatch +
(pg. 8)
FW –
AstroturfWatch +
Angel of Life + FW – FW –
AstroturfWatch + FW – rjblaskiewicz – Boris Ogon – Boris Ogon –
(pg. 9)
Lynne – guychapman – guychapman – guychapman – guychapman –
randy hinton + guychapman – Boris Ogon – Boris Ogon – guychapman –
(pg. 10)
guychapman –
randy hinton + guychapman – Sharon Hill – oval wooki –
randy hinton + guychapman – JGC2013 – guychapman –
AstroturfWatch +
(pg. 11)
guychapman – Allen Jones – claire G – claire G –
randy hinton + lilady –
Didymus Thomas + lilady –
Didymus Thomas + lilady –
(pg. 12)
Didymus Thomas + lilady –
Didymus Thomas +
Didymus Thomas +
Didymus Thomas +
Didymus Thomas +
“The Skeptic” Critics TOTAL 18-guychapman – 13-Boris Ogon – 10-FW – _8-rjblaskiewicz – _6-lilady – _3-Peter Lipson – _3-JGC2013 – _2-claire G – _2-Vered Yasur – _1-Paul Morgan – _1-Lynne – _1-Sharon Hill – _1-oval wooki – _1-Allen Jones – 70-TOTAL
Questioning “The Skeptic” Critics TOTAL
12-junkeeroo +
10-Angel of Life +
_7-Didymus Thomas +
_6-AstroturfWatch +
_5-randy hinton +
_1-Krista Cashatt +
_1-Kendra Sue Too +
_1-Tina Patterson +
_1-chriswinter + 44-TOTAL
guychapman, THIS “good evidence” that you’re “without” ?
The FDA’s Drug Review Process:
Ensuring Drugs Are Safe and Effective
“[T]he emphasis in Phase 2 is on EFFECTIVENESS”
“This phase aims to obtain PRELIMINARY DATA on whether the drug works in people who have a certain disease or condition”
“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2″
“These studies gather more information about safety and EFFECTIVENESS, studying different populations and different dosages and using the drug in combination with other drugs” http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm
“61 registered human trials, one completed, zero results published, from any of them.”
guychapman, do you mean THIS ?
clinicaltrials . gov does NOT contain the same data as the National Cancer Institute (NCI) at the National Institutes of Health (NIH) cancer . gov web-site:
61 TOTAL
1 – Not Yet Recruiting (Open)(Phase 3)
1 – Closed
2 – Terminated (Withdrawn due to slow enrollment)
7 – Withdrawn (This study has been withdrawn prior to enrollment)
10 – Recruiting (Open)
11 – Open (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)
10 – Recruiting (Open)
11 – Open (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)
10=Open
11=1 Not Yet Recruiting / 10 Recruiting
40=Closed
61-TOTAL
“The Burzynski fans’ snowstorm of irrelevant, low-grade publications in low impact journals and conference abstracts that aren’t even peer-reviewed, do not address this at all.”
guychapman, are you referring to THIS ?
The “National Cancer Institute (NCI) at the National Institutes of Health (NIH)
Cancer Clinical Trials,
15. What happens when a clinical trial is over?”
“The results of clinical trials are OFTEN published in peer-reviewed scientific journals”
” … WHETHER OR NOT the results are published in a peer-reviewed scientific journal … “ http://m.cancer.gov/topics/factsheets/clinical-trials This makes it clear that clinical trial results “are OFTEN” published, but sometimes they are “NOT” published “in a peer-reviewed scientific journal”
“The Helsinki Declaration states the obligations of those conducting trials in humans, and getting the results (good or bad) published and available is a core requirement.”
guychapman, WHERE does the Declaration of Helsinki indicate WHEN the final results of human clinical trials MUST be published?
“Gerson’s therapy is known to be ineffective and potentially harmful, but he used patient anecdotes – people sincerely convinced they had undergone a miracle cure – to promote his business.”
“What *objective* mechanism do you propose we use to distinguish between Burzynski and the quack Gerson?”
guychapman, how about the publications and Securities and Exchange (SEC) filings cited on my page 9 critique?
“2. Burzynski has registered 61 clinical trials in humans, completed one and published no useful data from any.”
guychapman, you obviously have a very “fast and loose” definition of “no useful data”
Exactly WHAT is your definition of “no useful data”?
“Can you name any mainstream cancer research operations that have similar rates of failure to compete and publish?”
guychapman, can you name any mainstream publications like Forbes that have similar rates of failure to “compete” and publish my 15+ comments in reply to your 18 comments?
Do you think it was because they knew that I would “rip you a new one” and you would be left there as the proverbial “Emperor (who) has no clothes”?
“3. How many people do you estimate are involved, globally, in the conspiracy to suppress Burzynski’s treatment?”
“My rough guess is a few hundred thousand.”
“Can you give a better estimate with reasons?”
guychapman, let’s start with YOU, guychapman (Guy Chapman, @SceptiGuy, @vGuyUK, http://www.chapmancentral.co.uk/blahg), your pals at Wikipedia; Jimmy (Jimbo) Donal Wales, http://www.jimmywales.com, (@jimmy_wales – whom you re-twit on Twitter), JzG|Guy, Guy, Anthony (AGK) BASC, Alexbrn, Dave Dial, Drmies, NE Ent, fluffernutter, foxj, jpgordon, Guerillero, Ironholds, John, Lord Sjones23, Tom Morris, Nstrauss, Steve Pereira/SilkTork, Rhode Island Red, Arthur Rubin, Choyoołʼįįhí:Seb az86556 (Seb az86556), Sgerbic, IRWolfie, Six words, Yobol, @RudyHellzapop, @_JosephineJones, @JCmacc1, @Malboury, @DianthusMed, @medTek, @StopBurzynski, @StortSkeptic, Dr. Peter A. Lipson (@palMD), #Forbes censor(s), Dr. David H. Gorski (@gorskon, @oracknows, @ScienceBasedMed, #sciencebasedmedicine, http://www.scienceblogs.com/Insolence, http://www.sciencebasedmedicine.org, The Faux Skeptic Revealed! Bob Blaskiewicz (@rjblaskiewicz, R.J. Blaskiewicz, Blatherskitewicz), C0nc0rdance, Boris Ogon, lilady, JGC2013, claire G, Sharon Hill, Allen Jones, Lynne, @JCmacc1, Paul Morgan (@drpaulmorgan), oval wooki, Vered Yasur, (the Forbes group) and http://burzynskimovie.com/images/stories/transcript/Documents/BurzynskiTriesToExposeNCI.pdf, etc.
“4. When you talk about Antineoplastons not being chemotherapy, what, in your mind, distinguishes the intravenous administration of one chemical from the intravenous administration of another, other than the fact that it’s Burzynski doing it?”
2/13/2013 – The frequency, cost, and clinical outcomes of HYPERNATREMIA in patients hospitalized to a comprehensive CANCER center http://www.ncbi.nlm.nih.gov/m/pubmed/23404230 Over 3 month period in 2006 re 3,446 patients, most of the HYPERNATREMIA (90 %) was acquired during hospital stay
Division of Internal Medicine, UT MD Anderson Cancer Center, Houston, TX, USA
Department of General Internal Medicine, University of Texas MD Anderson Cancer Center
Division of Endocrinology, Mayo Clinic
Support Care Cancer. 2013 Feb 13. [Epub ahead of print]
“In order to maintain their doses of ANP, patients are required to drink obscene amounts of water every day (some report up to 12 quarts or more)”
“If they fail to do so, they may lapse into unconsciousness or die”
Let’s put this in perspective
FACT: Some sources indicate:
1) A man should drink about
3 liters (101.44 ounces / 3 quarts 5.44 ounces) per day
{12 quarts = 384 ounces = 11.356 liters}
[12 quarts in 24 hours = 1/2 quart or 16 ounces per hour]
2) Extremely healthy kidneys could process about 30 ounces (approx .9 liters) of water in an hour
{30 ounces in 24 hours = 720 ounces}
[720 ounces = 22.5 quarts per day]
3) A person with healthy kidneys could develop water intoxication by drinking about 2 to 3 times what their kidneys can process
So, if extremely healthy kidneys could process about 30 ounces per hour and 12 quarts per day would require one to only drink 16 ounces per hour, that means one is being asked to drink 14 ounces less per hour than what extremely healthy kidneys could process
So even if one drinks more than 16 ounces per hour so that one does not have to be awake hourly, there is still opportunity to do that
Of course, there are certain other factors that might have to be taken into consideration depending on the patient
“6. Burzynski has convinced you that he can cure incurable cancers.”
“What figures has he given you for his five-year survival versus standard of care?”
guychapman, HERE:
2003 – Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma:
incurable recurrent and progressive multicentric glioma
6 patients were diagnosed with pilocytic astrocytoma
4 with low-grade astrocytoma
1 with astrocytoma grade 2
1 case of visual pathway glioma, a biopsy was not performed due to a dangerous location
1 patient was non-evaluable due to only 4 weeks of ANP and lack of follow-up scans
1 patient who had stable disease discontinued ANP against medical advice and died 4.5 years later
10 patients are alive and well from 2 to >14 years post-diagnosis
2004
Protocol – incurable recurrent and progressive multicentric glioma
12 – Patients Accrued
– Evaluable Patients
33% – % of Patients Showing Complete Response
25% – % of Patients Showing Partial Response
33% – % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease
2005 – Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with antineoplastons A10 and AS2-1 http://www.ncbi.nlm.nih.gov/m/pubmed/15911929 Integr Cancer Ther. 2005 Jun;4(2):168-77
13 children with recurrent disease or high risk
6 (46%) survived more than 5 years
2005
Protocol – recurrent disease or
high risk
– Patients Accrued
– Evaluable Patients
23% – % of Patients Showing Complete Response
8% – % of Patients Showing Partial Response
31% – % of Patients Showing Stable Disease
38% – % of Patients Showing Progressive Disease
2006 – Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma http://www.ncbi.nlm.nih.gov/m/pubmed/16484713 Integr Cancer Ther. 2006 Mar;5(1):40-7
Brainstem glioma carries the worst prognosis of all malignancies of the brain
Most patients with brainstem glioma fail standard radiation therapy and chemotherapy and do not survive longer than 2 years
Treatment is even more challenging when an inoperable tumor is of high-grade pathology (HBSG)
patients with inoperable tumor of high-grade pathology (HBSG) treated with antineoplastons in 4 phase 2 trials
22% – overall survival at 5 years
17+ years maximum survival for a patient with anaplastic astrocytoma
5+ years for a patient with glioblastoma
5+ year survival in recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem in a small group of patients
Table II. Treatment of diffuse, intrinsic brainstem glioma in children
Burzynski et al. [88] – Reference
Phase II – Study Type
(no. of pts) – pts = patients
RP (30) – RP = recurrent and progressive tumor – Tumor type
ANP – ANP = antineoplastons A10 and AS2-1 – Treatment – ANP
OS (%) – OS = overall survival
[2y; 5y]
46.7; 30 – Efficacy
MST (mo)
19.9 – MST = median survival time
[% (no. )]
27 (8) – CR – CR = complete response
[% (no. )]
20% (6) – PR – PR = partial response
[% (no. )]
23% (7) – SD – SD = stabile disease
30% (9) – PD = progressive disease pg 177
88. Burzynski SR, Weaver RA, Janicki T. Long-term survival in phase II studies of antineoplastons A10 and AS2-1 (ANP) in patients with diffuse intrinsic brain stem glioma [abstract]. Neuro-oncol 2004; 6: 386
This is the 2004 publication, NOT 2003
Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma : a preliminary report. http://www.ncbi.nlm.nih.gov/m/pubmed/15563234 Drugs R D. 2004;5(6):315-26
pg 172
Burzynski et al. [89] – Reference
Phase II – Study Type
(no. of pts) – pts = patients
RPS (10) – RPS = recurrent and progressive tumors in children aged <4y – Tumor type {(66) = most in a study}
ANP – ANP = antineoplastons A10 and AS2-1 – Treatment – ANP
OS (%) – OS = overall survival
[2y; 5y] – Efficacy
60; 20 {46.7 (30) = next best study}
MST (mo)
26.3 – MST = median survival time – {19.9 = next best study}
[% (no. )]
30% (3) – CR = complete response – {27% (8) = next best study}
[% (no. )]
0% (0) – PR = partial response – {56% (1) = next best}
[% (no. )]
40% (4) – SD = stable disease – {44% (25) = best}
[% (no. )]
30% (3) – PD = progressive disease – {23% (13) = best}
(Above, I also provide the best next case to compare to)
pg 177
89. Burzynski SR, Weaver RA, Janicki TJ, et al. Targeted therapy with ANP in children less than 4 years old with inoperable brain stem gliomas [abstract]. Neuro-oncol 2005; 7: 300
Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with antineoplastons A10 and AS2-1. http://www.ncbi.nlm.nih.gov/m/pubmed/15911929 Integr Cancer Ther. 2005 Jun;4(2):168-77
pg 173
1.4.3 Targeted Therapy
“…multi-targeted therapy with ANP has shown promising results [12;88-91]”
pg 176
90. Burzynski SR, Lewy RI, Weaver RA, et al. Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma: a preliminary report. Drugs R D 2003; 4: 91-101
Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma: a preliminary report. http://www.ncbi.nlm.nih.gov/m/pubmed/12718563 Drugs R D. 2003;4(2):91-101
91. Burzynski SR, Weaver RA, Janicki T. et al. Targeted therapy with antineoplastons A10 and AS2-1 (ANP) of high-grade, recurrent and progressive brain stem glioma. Integr Cancer Ther 2006 Mar; 5 (1): 40-7
Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma. http://www.ncbi.nlm.nih.gov/m/pubmed/16484713 Integr Cancer Ther. 2006 Mar;5(1):40-7
30 evaluable patients with recurrent and progressive DBSG
“>40% of patients survived for more than 2 years
30% more than 5 years.”
Multi-targeted ANP therapy is free from chronic toxicity in children and adults based on the results of numerous clinical studies involving
1652 adults
335 children
[147]
pg 178
147. Burzynski SR. Annual report to the FDA, IND 43,742, 2006
pg 174
Long-term follow-up of children treated with ANP for astrocytomas revealed:
normal development
no cognitive or endocrine deficiencies
normal fertility
>5 years – substantial number of patients tumor free
>17 years – follow-up period for some patients
pg 169
1.1.4. Targeted Therapy
Clinical trials with agents affecting single targets are in progress and the preliminary results of multi-targeted therapy with
antineoplastons (ANP) A10
and
AS2-1 have been reported
[39]
small group of patients with progressive LGA, ANP
60% – CR rate – Complete Response
10% – PR rate – Partial Response
median survival 7 years 9 months
maximum survival of more than 15 years
[39]
LGA = Low-Grade Astrocytomas
Table I. Selected chemotherapy regimens for the treatment of low- grade astrocytoma in children
Burzynski [39] – Reference
Phase II d – d = Preliminary results – Study type
P – P = progressive tumor – Tumor type
(no. of pts) – pts = patients
ANP (10) – ANP = antineoplastons A10 and AS2-1 – Treatment {(78) = most in a study}
OS [%] – OS = overall survival
100% (1 yr) – 90% (3 yr) – Efficacy
93 mo – MST = MST = median survival time – {96 (1 y) next closest}
CR [% (no.)]
60% (6) – CR = complete response {24 (11) next closest}
PR [% (no.)]
10% (1) – PR = partial response {60% (9) best other study}
[% (no.)]
30% (3) – SD = stable disease + MR = minor response {70% (14) best other study}
[% (no.)]
0% (0) – PD = progressive disease {4% (2) next closest}
PFS (%)
90 (1 y) – 90 (3 y) – PFS = progression-free survival {100 (1 y) – 68 (3 y) best other study
(Above, I also provide the best next case to compare to)
pg 176
39. Burzynski SR Clinical application of body epigenetic system: multi-targeted therapy for primary brain tumors. World and Ehrlich Conference on Dosing of Magic Bullets; 2004 Sep 9-11 Nurnberg
Otherwise, check with the Food and Drug Administration (FDA)
Where are they published?
guychapman, if you have NOT yet figured THAT out…
“7. There are numerous cases where the Burzynski clinic has said a tumour is “dying from the inside”, but where it turns out that it is growing aggressively and suffering necrosis due to outstripping its blood supply; this is usually a precursor to the death of a patient only weeks after being told they were on the way to a cure.”
“How do you account for this repeated error?”
guychapman, WHERE is the documentation?
Boris Ogon
“You are right now having a live “debate” in front of more than 10,000 people, … “
3,919 views
Not so much
Waiting for the 10,000
4/19/2013 @ 9:43PM
Peter Lipson: “Speech is best countered by more speech”
Musings on the intersection of Articles, Bias, and Censorship
(The Big 3: A.B.C.)
4/19/2013 @ 9:43PM
A Film Producer, A Cancer Doctor, And Their Critics
guychapman 5 days ago
“Ah yes, a 1996 news story based on claims from the clinic.”
guychapman, would you like an opportunity to re-read the below and try again?
junkeeroo 1 week ago
The Washington Times, December 5, 1996:
Doctor’s lifesaving effort could land him in prison
– FDA ignores cancer drug’s success
HOUSTON – Federal prosecutors concede that a cancer doctor they will put on trial here in January for using an innovative but unapproved drug has been “saving lives.”
guychapman, that’s NOT
“…claims from the clinic”
“Bold claims, too. Since then he’s registered 61 clinical trials.”
guychapman, that’s NOT taking into consideration the 72 clinical trials listed on the Securities and Exchange (SEC) filings for
11/25/1997 – Form 10-SB
11/25/1997 – Company sponsoring 72 Phase II clinical trials conducted pursuant to INDs filed with FDA which are currently ongoing
“Where are the published results that back his claims?”
“I mean, Watergate only involved a handful of people and it was busted almost immediately.”
guychapman, you employ a favorite tactic of critics like you
It seems you are more interested in addressing form (CAPITALIZATION) over substance (the real issues)
Maybe you think that your verbosity (17 posts) will somehow lend credibility to your 3 comments re the Declaration of Helsinki; which does NOT state WHEN human clinical trial results MUST be published, and even though you have repeatedly proclaimed that Burzynski has NOT published the FINAL results of any of his phase 2 clinical trials, you have NOT provided any indication as to WHEN any of those trials were completed so that they can be compared to the 2006 study I cited whose results were published in 2013
You also commented:
“In order to claim that he can cure incurable tumours, he needs to publish high quality clinical trial evidence in peer-reviewed journals,”
yet you do NOT provide any citation, reference, or link that overrides the National Cancer Institute (NCI) at the National Institutes of Health (NIH) information re publication which I have commented on previously.
It is apropo you commented:
“Watergate only involved a handful of people and it was busted almost immediately,”
since President Nixon is credited with starting the
“War on Cancer”
and when Watergate occurred he was told that there was a cancer on the Presidency, but Watergate occurred in 1972 and Nixon didn’t resign until 2 years later, in 1974
It is also appropriate that you mention oncologist David Gorski; who disclosed on social media that Peter Lipson is his “pal”
Did you review Burzynski’s 2003-2006 phase 2 clinical trials preliminary reports to see if any of the authors listed on them is an oncologist?
No?
That’s why your observation that Burzynski (a biochemist) is NOT an oncologist, is irrelevant
Do you have any proof to back up your remarkable claim:
“Against that we have an anonymous shill who takes every word of the Burzynski clinic and its supporters as Revealed Truth”?
No?
That’s because you’re wrong about that just like the other issues I’ve listed above
Mr. Chapman, you attempts at obfuscation of the issues, does not impress
guychapman 5 days ago
You don’t really understand the scientific concept of proof do you?
guychapman, you do NOT really understand the concept of proof, do you?
“That probably explains why you are swallowing Burzynski’s PR hook line and sinker.”
guychapman, NO, unlike you, I actually reviewed things and am able to provide “citations,” “references,” and / or “links”
“In order to claim that he can cure incurable tumours, he needs to publish high quality clinical trial evidence in peer-reviewed journals.”
guychapman, where is your “citation(s),” “reference(s),” and / or “link(s)”?
“He needs to publish his science in a way that others can understand and replicate.”
“The appeal to conspiracy as an excuse for failure to publish any compelling results is a stable feature of quackery.”
guychapman, YOU ARE part of the “conspiracy” as long as you remain silent and play “dumb” about things like “censorship” and “bias” by Wikipedia; who you are the “apologist” for, and Forbes
“It is not a feature of science as such.”
And neither is your ignorance and inability to provide any citation(s), reference(s), and / or link(s)
guychapman 5 days ago
“That was 1996. Since then he’s registered 60 phase II and eon phase III clinical trials.”
guychapman, “eon”?
“Of these he has completed only one, and has failed to publish any meaningful data from any”
guychapman, where is your in-depth review of these publications?
Drugs in R and D (Drugs in Research and Development)
“PDJT aka “Astroturfwatch” – the irony of a contributor to an astroturfing campaign of the magnitude of Burzynski’s calling skeptics for non-existent astroturfing is amusing.”
guychapman, are you related to, or know this “lilady”?
“Find just one, any single cure for this tumor type and you can’t, outside of Antineoplastons”
guychapman, NO, “you” did NOT say that, since I am NOT “you”
(Forbes)
Didymus Thomas 5 days ago
As former President Ronald Reagan used to say: “Well, there you go again.”
Let me make this perfectly clear and unambiguous as I can.
1. I am NOT Dr. Stanislaw R. Burzynski, I have never worked for him, I have never met him.
2. I am NOT AstroTurfWatch.
3. I am NOT Eric Merola, I have never worked for him, I have never met him.
4. I am NOT Randy Hinton, I have never met him, this article is the first place I have seen his name.
“What you mean is:”
“Find just one, any single cure for this tumor type and you can’t, including Antineoplastons”.
guychapman, when are you going to show whether you are just a coward or not, and PROVE IT?
“Because the point about which you are in denial is that there is no credible evidence that antineoplastons cure anything.”
guychapman, WHAT does this indicate?
The FDA’s Drug Review Process:
Ensuring Drugs Are Safe and Effective
“[T]he emphasis in Phase 2 is on EFFECTIVENESS”
“This phase aims to obtain PRELIMINARY DATA on whether the drug works in people who have a certain disease or condition”
“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2″
“These studies gather more information about safety and EFFECTIVENESS, studying different populations and different dosages and using the drug in combination with other drugs” http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm
“The endlessly repeated list of low quality publication does not come anywhere close to filling in the gap which ought to be filled by the sixty-one human trials he never published – and all the available evidence indicates he never had any intention of doing so.”
guychapman, WHAT does this indicate?
The “FACT” one should know is that clinicaltrials . gov does NOT contain the same data as the National Cancer Institute (NCI) at the National Institutes of Health (NIH) cancer . gov web-site:
61 TOTAL
1 – Not Yet Recruiting (Open)(Phase 3)
1 – Closed
2 – Terminated (Withdrawn due to slow enrollment)
7 – Withdrawn (This study has been withdrawn prior to enrollment)
10 – Recruiting (Open)
11 – Open (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)
10 – Recruiting (Open)
11 – Open (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)
10=Open
11=1 Not Yet Recruiting / 10 Recruiting
40=Closed
61-TOTAL
“I don’t think he cares any more about the Helsinki Declaration than he does about any other area of medical ethics.”
guychapman, have you even read the Declaration of Helsinki?
Because if you had, you should be able to indicate which section supports your comment
WHAT was that you were saying about “ethics”?
guychapman 5 days ago
“There’s an interesting parallel with Burzynski here.”
guychapman, there’s an interesting parallel with guychapman, Guy Chapman, @SceptiGuy, @vGuyUK, and the Wikipedia Guys: JzG|Guy and Guy (Help!) http://t.co/N7ErbunCV2 Wikipedia, what’s your motivation?
redd.it/1dk974 Didymus Judas Thomas’ http://redd.it/1dk974 Hipocritical Oath Blog http://www.reddit.com/tb/1dk974
guychapman, thank you for bringing up the issue of:
“absence of credible evidence”
THAT describes you to a “T”
If the shoe fits, wear it
“How do you recommend we should tell the difference between Burzynski and his shill Merola, and the palpable fraud and quack Hoxsey?”
guychapman,
“How do you recommend we should tell the difference between guychapman and his shill Guy Chapman, and the palpable fraud and quack @SceptiGuy / @vGuyUK?”
Guy (Help!)
User:JzG/help|Help!
Trust me, Guy, nothing can help YOU
Boris Ogon 6 days ago
“One interesting element is that Merola himself hasn’t shown up to defend his vexatious DMCA claim, which he has effectively admitted to be meritless by offering to drop it if c0nc0rdance can somehow get the after-the-fact third-party mirrors to not include his E-mail address.”
Boris Ogon, did you entirely ignore the Forbes article?
"A well-known “vlogger” who goes by the handle “C0nc0rdance” reports receiving a DMCA take-down notice from Eric Merola after posting a video critical of Burzynski."
"According to C0nc0rdance: He objected to my “Fair Use” of a small low-res image of his movie poster.”
“Instead, he drops a post on his Facebook page complaining about this article and mischaracterizing the situation, and 10 minutes later, his adherents appear and start babbling incoherently.”
“Wow, and people say the “Skeptics” (aka Astroturf campaign) aren’t powerful and with the system behind them.”
“This is what happens when I take down a YouTube video making false claims against my film and Burzynski as well as illegally using copyrighted images of me without permission within (not to mention publishing my personal emails in which I received countless profanity filled threats also in their YouTube post, and they claim “we” threaten – this is the system fighting back, hard):
For anyone unfamiliar with the tiresome tactic of “Didymus [Judas] Thomas” of trying to drive signal-to-noise ratio into the ground while being completely unable to respond coherently, this is not a bad place to start: http://goo.gl/f59kT
He was eventually blocked under the “Competence is Required” policy and started shooting off typically garbled E-mails to Jimmy Wales demanding personal attention.
Mr. Ogon, do you have a relationship with Wikipedia?
Mr. Ogon, did you research THIS on Wikipedia?
[“Remedies may be appealed to, and amended by, Jimbo Wales, …”
([[WP:AP]] Wikipedia:Arbitration/Policy 2.9 Appeal of decisions)]
Musings on the intersection of Articles, Bias, and Censorship
(The Big 3: A.B.C.)
4/19/2013 @ 9:43PM
A Film Producer, A Cancer Doctor, And Their Critics
FW 6 days ago
"“Making people undergo clinical trials that hold no promise” – Quite, it is abhorrent that Burzynski does this, and has been doing it for many years."
FW (also known as @frozenwarning), has no proof that anyone is “Making people undergo clinical trials…"
FW continues:
"The FDA was ordered by a scientifically illiterate judge to allow these trials, they had no choice."
FW again makes an unsubstantiated claim
"That the FDA hasn’t stopped this charade is bizarre and inexcusable IMO."
http://www.china-burzynski.com/lxwm
"There is, as yet, no evidence that he has cured any type of cancer, all we have are a few, mainly historical anecdotes."
FW, have you seen this?
"The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective" advises:
“[T]he emphasis in Phase 2 is on EFFECTIVENESS”
“This phase aims to obtain PRELIMINARY DATA on whether the drug works in people who have a certain disease or condition”
“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2″
“These studies gather more information about safety and EFFECTIVENESS, studying different populations and different dosages and using the drug in combination with other drugs” http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm
"By the way, the Phase 3 trial that is registered to Burzynski is not for brain tumours, sorry to disappoint you."
FW, are you saying that you do NOT know what you are writing about?
Because, that is what it looks like to me
Burzynski's Securities and Exchange Commission (SEC) Form 10-Q for the quarterly period ended 5/31/2010 states:
1/13/2009 Company announced Company had reached an agreement with FDA for Company to move forward with pivotal Phase III clinical trial of combination Antineoplaston therapy plus radiation therapy in patients with newly diagnosed, diffuse, intrinsic brainstem gliomas (DBSG)
Agreement was made under FDA’s Special Protocol Assessment procedure, meaning design and planned analysis of Phase III study is acceptable to support regulatory submission seeking new drug approval
2/1/2010 Company entered into agreement with Cycle Solutions, Inc., dba ResearchPoint to initiate and manage pivotal Phase III clinical trial of combination Antineoplastons A10 and AS2-1 plus radiation therapy (RT) in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma
ResearchPoint is currently conducting feasibility assessment
ResearchPoint has secured interest and commitment from number of sites selected
Upon completion of assessment, randomized, international phase III study will commence
Study's objective is to compare overall survival of children with newly-diagnosed DBSG who receive combination Antineoplastons A10 and AS2-1 plus RT versus RT alone
AstroturfWatch 6 days ago
AstroturfWatch, in referring to the author of the article, as well as some of the individuals who posted comments unsupported by any facts, stated:
"And truth and integrity is not an option for them."
"They refuse to fact check anything."
"Anyone can be a journalist nowadays, and “fact-checking” is no longer even on the table."
"So you’d rather get your information from an advertising film than doctors, scientists and researchers."
Dr. Burzynski is a doctor, as is his wife, and if you look at the co-authors on his clinical trial publications, and actually research them, you can determine what they are, as well
"That’s your choice, misguided though it is."
If anyone has been "misguiding" anyone, I would say that it is the author, you, and a number of other individuals who posted comments
"Don’t expect rational people to stop trying to stop Burzynski though."
I do NOT see that you've been "rational"
"What he is doing is unscientific, unethical and immoral."
It's good to learn that you are now judge, jury, and executioner
You remind me of Wikipedia
"Also, the moon landings were real."
FW, it's good to learn that at least you got one thing correct
junkeeroo 6 days ago
FW, I understand that for you “rational and intelligible” means that it corresponds to your biased framework.
Perhaps one day you or your conscience will awaken to reality.
junkeeroo, good point, but I do NOT believe its going to happen any time soon
junkeeroo 6 days ago
re: rather “than doctors, scientists and researchers”
You truly do live in lala-land.
Best of luck to you…
What junkeeroo said
Author
Peter Lipson, Contributor 6 days ago
"There is ZERO published data to support these assertions."
"Please, if you know of something out there other than what you saw in a movie, let us know."
Dr. Lipson, if that's what you call these, oh, well
"I have no particular interest int he FDA as I work for the NHS in the UK,which also doesn’t support Burzynski due to the lack of evidence on efficacy and safety, and the dubious practices."
FW, sounds like you could use a little help, just like Dr. Lipson:
FW, from what I can tell, if anyone has proven to be a "blind disciple," it has been YOU
"Not once has he addressed the perfectly valid criticisms."
FW, I said it before and I'll say it again:
It’s a bit hard to address anything when Forbes is censoring (deleting) your comments
"Let’s look at it this way, if Burzynski had a 25% success rate, why has he not published this miraculous data?"
"Yet again, you show that Burzynski supporters do not know what they are reading."
FW, on the subject of people NOT knowing what they are reading, you do NOT appear very knowledgeable, considering your lack of any citation(s), reference(s), and / or links
Boris Ogon
“You are right now having a live “debate” in front of more than 10,000 people, … “
Peter Lipson, Contributor
Musings on the intersection of science, medicine, and culture
3,799 views
Not so much
Waiting for the 10,000
4/19/2013 @ 9:43PM
Peter Lipson: “Speech is best countered by more speech”
Didymus Judas Thomas' Hipocritical Oath Blog 