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

20131021-200529.jpg

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

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

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

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

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

“And it’s always been his burden of proof

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

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

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

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

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

Subpart F–Confidentiality of Information

Sec. 601.50

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

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

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

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

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

Burzynski ?

FDA ?

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

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

“It is Burzynski’s job to be convincing”

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

“In decades”

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

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

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

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

“It’s ultimately Burzynski”

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

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

“That doesn’t”

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

“How long would it take ?”

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

“Years ?”

“How long ?”

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

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

“I can do that”

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

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

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

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

“You’re you’re you’re assuming”

“You’re you’re you’re assuming that”

“You’re assuming that”

“Um, I’m not assuming that”

“There is a correct answer here”

“You don’t know”

“You don’t know”

“You need to look into it”

“Alright ?”

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

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

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

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

“I try to fight against it, constantly”

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

“He withdrew the the phase 3 clinical trial”

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

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

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

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

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

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

“What about the the Public Library of Science?”

“It’s not the only journal there”

“What about BMC Cancer ?”

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

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

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

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

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

So

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

“How long will it take ?”

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

“We can’t find it anywhere”

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

“We can’t find that anywhere”

“We’ve asked”

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

“And, and it hasn’t come to us

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

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

1. Annals of Oncology 2010;21:viii221 ?

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

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

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

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

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

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

“We’re talking about life”

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

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

“This is important stuff”

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

“It’s nothing”

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

“You know”

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

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

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

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

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

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

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

You know, I don’t necessarily agree with that

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

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

“You know”

“They’re just saying, “No thanks””

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

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

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

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

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

“Is that what you’re saying ?”

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

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

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

“I mean you just can’t

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

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

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

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

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

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

“Right ?”

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

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

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

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

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

“Right ?”

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

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

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

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

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

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

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

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

“The FDA’s in control”

“They sign off on these things”

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

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

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

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

“That’s important”

“That that that’s really important

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

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

“And that’s important”

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

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

“Gorski has made it abundantly clear”

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

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

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

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

You know

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

“Send me that”

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

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

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

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

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

Bob, who approves “Accelerated Approval” ?

1. FDA ?

2. A peer-reviewed scientific journal ?

3. The Skeptics™ ?

Bob, It’s your unlucky [13]
======================================
REFERENCES:
======================================
[1] – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/04/september-28-2013-the-skeptics-burzynski-discussion-by-bob-blaskiewicz-21951/
======================================
[2] – FDA grants Orphan Drug Designation (ODD) for A10 and AS2-1:
——————————————————————
http://www.burzynskiresearch.com/assets/PressRelease_12022008_BZYR(2).pdf
——————————————————————
josephinejones (@_JosephineJones), D Nile ist http://josephinejones.wordpress.com/2013/01/23/happy-birthday-dr-burzynski-and-goodbye-antineoplastons/comment-page-1/#comment-8921
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/23/josephinejones-_josephinejones-d-nile-ist-httpjosephinejones-wordpress-com20130123happy-birthday-dr-burzynski-and-goodbye-antineoplastonscomment-page-1comment-8921/
======================================
[3] – The Skeptics @Majikthyse reveals madjik research skilz:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/26/the-skeptics-majikthyse-reveals-madjik-research-skilz/
======================================
[4] – Critiquing David H. Gorski, MD, PhD, FACS http://www.sciencebasedmedicine.org/editorial-staff/david-h-gorski-md-phd-managing-editor/
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/21/critiquing-david-h-gorski-md-phd-facs-www-sciencebasedmedicine-orgeditorial-staffdavid-h-gorski-md-phd-managing-editor/
======================================
[5] – The Lancet Oncology
——————————————————————
http://www.thelancet.com/journals/lanonc/onlinefirst
——————————————————————
http://www.thelancet.com/journals/lanonc/issue/current
======================================
[6] – FINALLY, one of “The Skeptics™” has the “Balls” to do what even Dr. David H. “Orac” Gorski would NOT do:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/12/finally-one-of-the-skeptics-has-the-balls-to-do-what-even-dr-david-h-orac-gorski-would-not-do/
======================================
[7] – Burzynski – The Antineoplaston Randomized Japan Phase II Clinical Trial Study:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/28/burzynski-the-antineoplaston-randomized-japan-phase-ii-clinical-trial-study/
======================================
[8] – Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet “fact sheet”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/19/critiquing-national-cancer-institute-nci-at-the-national-institutes-of-health-nih-cancernet/
======================================
[9] – Stanislaw Rajmund Burzynski Publications:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/16/stanislaw-rajmund-burzynski-publications/
======================================
[10] – Critiquing: In which the latest movie about Stanislaw Burzynski “cancer cure” is reviewed…with Insolence:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/18/critiquing-in-which-the-latest-movie-about-stanislaw-burzynski-cancer-cure-is-reviewed-with-insolence-2/
======================================
[11] – QUESTIONS the Critics and Cynics, “The Skeptics™” do NOT want to ANSWER:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/23/questions-the-critics-and-cynics-the-skeptics-do-not-want-to-answer/
======================================
[12] – The Biggest Loser: “The Skeptics™” Guy Chapman (guychapman @vGuyUK @SceptiGuy) http://www.chapmancentral.co.uk/blahg/ – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/18/the-biggest-loser-the-skeptics-guy-chapman-guychapman-vguyuk-sceptiguy-httpwww-chapmancentral-co-ukblahg-september-28-2013-the-skeptics/
======================================
[13] – Burzynski: Why has the FDA NOT granted Accelerated Approval for Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal) ?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/28/burzynski-why-has-the-fda-not-granted-accelerated-approval-for-antineoplastons-a10-astengenal-and-as2-1-astugenal/
======================================

Dr. Michael A. Friedman, DATA ?

[1] – 11/2/1993 – Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Services, National Institutes of Health (NIH), sent a 3 page letter to Burzynski, which advised, in part, on page 1:

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

“The Theradex database is also available … “
——————————————————————
[1] – 11/2/1993 – This makes it clear that: “review of data” is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-161419.jpg

20130918-152526.jpg
[2] – 1995 (4/3/1995) – Dr. Mario Sznol, Department of Health & Human Services (HHS), Public Health Services, National Institutes of Health (NIH), National Cancer Institutes (NIH), sent a 2 page letter for Dr. Michael A. Friedman, to Burzynski, in response to his letter of 3/29/1995, which advised, in part, on page 1:

“We will forward the data on the 1st 5 patients in a separate mailing as you requested”
——————————————————————
[2] – 4/3/1995 – This makes it clear that: “We will forward the data … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-134020.jpg

20130918-134632.jpg
[3] – 1995 (4/20/1995) – Burzynski sent a letter to Dr. Mario Sznol, Department of Health & Human Services (HHS), National Institutes of Health (NIH), in response to his letter of 4/3/1995, which advised, in part, on page 2:

“We are anxiously awaiting the complete data on the 1st 5 patients as promised in your letter of 4/3/1995″
——————————————————————
[3] – 4/20/1995 – This makes it clear that: “We are anxiously awaiting the complete data … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-162456.jpg
[4] – 1995 (5/16/1995) – Burzynski sent a letter to Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), National Institutes of Health (NIH), in response to his letter of 5/12/1995, which advised, in part, on page 2:

“I still have not received the complete data on the 1st 5 patients, which was promised in your letter of 4/3/1995″
——————————————————————
[4] – 5/16/1995 – This makes it clear that: “I still have not received the complete data … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-164323.jpg
[5] – 1995 (6/6/1995) – Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH), sent a 3 page letter to Burzynski, in response to his letters of 4/20/1995 and 5/16/1995, which advised, in part, on page 1:

“Also contrary to your statement, you have been sent monthly clinical summaries of these patients since 7/1994 directly from Theradex

(see 3/9/1994 letter)
——————————————————————
[5] – 6/6/1995 – This makes it clear that: ” … you have been sent monthly clinical summaries … directly from Theradex IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-165840.jpg
[6] – 8/23/1995 – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Council, Public Health Division, sent a 1 page letter to Burzynski’s attorney, Richard A. Jaffe, Esq., which he copied Dr. Michael A. Friedman on, which was in response to his letter of 7/21/1995, which advised, in part:

” … you requested in your letter that we provide you or Dr. Burzynski with the medical records of patients treated by the Principle Investigators”

“To our knowledge, Dr. Burzynski has received, on an ongoing basis, complete copies of the reports prepared by Theradex after the Principle Investigators submit their data”

“Dr. Burzynski has received precisely the same information that is provided to the National Cancer Institute (NCI)”

“The NCI does not possess any individual patient records to provide to Dr. Burzynski”
——————————————————————
[6] – 8/23/1995 – This makes it clear that: ” … Dr. Burzynski has received … complete copies of the reports prepared by Theradex after the Principle Investigators submit their data” IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-154154.jpg
[7] – 1995 (9/19/1995) – Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH), sent a 2 page letter to Burzynski, which advised, in part:

“I am replying to your 8/29/1995, letter in which you requested “detailed records” of the patients treated in the National Cancer Institute sponsored trials of antineoplastons”

“Our records indicate that the data has been regularly supplied to you by our contractor, Theradex, as listed below:”

7/18/1994 Clinical Studies Summary
8/24/1994 Clinical Studies Summary
9/19/1994 Clinical Studies Summary
10/24/1994 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report
11/14/1994 Clinical Studies Summary
12/19/1994 Clinical Studies Summary
1/13/1995 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report
2/21/1995 Clinical Studies Summary
3/15/1995 Clinical Studies Summary
4/10/1995 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report

Pg. 2

“We have no individual patient records in our possession in addition to the Theradex reports”
——————————————————————
[7] – 9/9/1995 – This makes it clear that: ” … data has been regularly supplied to you by our contractor, Theradex … :” IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-160216.jpg

20130918-161029.jpg
[8] – 10/5/1995 – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Counsel, Public Health Division, sent a 1 page letter to Burzynski’s attorney, Richard A. Jaffe, Esq., which advised, in part:

“This is in response to your 9/8/1995 letter in which you reiterate your request for copies of individual patient records and argue that the protocol for the study of Antineoplastons specifically provides that medical records of patients treated by the Principal Investigators will be provided to Dr. Burzynski”

“It is our understanding that NCI offered to allow Dr. Burzynski to participate in an interim and final meeting in which patient data from the study was to be reviewed”

“However, these meetings never took place because of the insufficient patient accrual and decision not to complete the study”

“With regard to the portion of the medical record which you forwarded, the stamp does indicate that the patient was seen at the National Institutes of Health’s Clinical Center”

“We have learned that 2 patients were enrolled in the Sloan-Kettering study through the Clinical Center and hence, even though the Clinical Center did not have its own protocol, it has medical records for those 2 individuals”
——————————————————————
[8] – 10/5/1995 – This makes it clear that: “… these meetings never took place because of the insufficient patient accrual and decision not to complete the study”, is NOT Theradex, but the prior letters do NOT mention the word “MEETINGS”
=======================================
[1] – 11/2/1993 – This makes it clear that: “REVIEW OF DATA” is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[2] – 4/3/1995 – This makes it clear that: “WE WILL FORWARD THE DATA … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[3] – 4/20/1995 – This makes it clear that: “We are anxiously awaiting the complete DATA … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[4] – 5/16/1995 – This makes it clear that: “I STILL HAVE NOT RECEIVED THE complete DATA … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[5] – 6/6/1995 – This makes it clear that: ” … you have been sent monthly clinical summaries … directly from Theradex IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[6] – 8/23/1995 – This makes it clear that: ” … Dr. Burzynski has received … complete copies of the reports prepared by Theradex after the Principle Investigators submit their data” IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[7] – 9/9/1995 – This makes it clear that: ” … data has been regularly supplied to you by our contractor, Theradex … :” IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-154926.jpg
Why would you advise Burzynski:

[2] – 4/3/1995 – “WE WILL FORWARD THE DATA” if you had FORWARDED “THE DATA” since

[5] + [8] – the 7/18/1994 Theradex Clinical Studies Summary ?

Dr. Michael A. Friedman, DATA ?

Where is the DATA ?
=======================================

DID Dr. Michael A. Friedman FIB ?

[1] – 6/6/1995 – Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH), sent a 3 page letter to Burzynski, in response to his letters of 4/20/1995 and 5/16/1995, which advised, in part, on page 1:

“I will 1st address the questions you raised about individual patients participating in the NCI-sponsored antineoplaston studies

“2 patients were treated at the National Cancer Institute”

Patient .26-77-03-9 … at the NCI

Patient .27-53-76-5 … “
——————————————————————
6/6/1995 we know “2 patients were treated at the National Cancer Institute” [1]

20130918-165840.jpg
[2] – 8/23/1995 – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Council, Public Health Division, sent a 1 page letter; which he copied Dr. Michael A. Friedman on, to Burzynski’s attorney, Richard A. Jaffe, Esq., which was in response to his letter of 7/21/1995, and advised, in part:

” … you requested in your letter that we provide you or Dr. Burzynski with the medical records of patients treated by the Principle Investigators”

“The NCI does not possess any individual patient records to provide to Dr. Burzynski”
——————————————————————
6/6/1995 we know per Dr. Michael A. Friedman’s letter that “2 patients were treated at the National Cancer Institute” [1]

8/23/1995 we know that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients per National Institutes of Health (NIH) Legal Advisor Robert B. Lanman [2]

20130918-154154.jpg
[3] – 9/19/1995 – Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH), sent a 2 page letter to Burzynski, which advised, in part:

“I am replying to your 8/29/1995 letter in which you requested “detailed records” of the patients treated in the National Cancer Institute sponsored trials of antineoplastons

Pg. 2

We have no individual patient records in our possession in addition to the Theradex reports”
——————————————————————
6/6/1995 we know from Dr. Michael A. Friedman’s letter that “2 patients were treated at the National Cancer Institute”[1]

8/23/1995 we know that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients per National Institutes of Health (NIH) Legal Advisor Robert B. Lanam’s letter [2]

9/19/1995 we know that Dr. Michael A. Friedman advised that “We have no individual patient records in our possession …”[3]

8/23/1995 we know that Dr. Michael A. Friedman was copied on Robert A. Lanman’s letter which stated that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients [2]

All Americans are “presumed to know the law”, so we know that Dr. Michael A. Friedman would have advised Robert B. Lanman if his 8/23/1995 written statement to Burzynski’s attorney, Richard A. Jaffe, Esq., was NOT TRUE [2]

[0] – Title 18, Part I, Chapter 47, § 1001

18 USC § 1001 – Statements or entries generally

(3) “makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry”

20130918-160216.jpg

20130918-161029.jpg
[4] – 10/5/1995 – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Counsel, Public Health Division, sent a 1 page letter to Burzynski’s attorney, Richard A. Jaffe, Esq., which advised, in part:

“This is in response to your 9/8/1995 letter in which you reiterate your request for copies of individual patient records and argue that the protocol for the study of Antineoplastons specifically provides that medical records of patients treated by the Principal Investigators will be provided to Dr. Burzynski”

“With regard to the portion of the medical record which you forwarded, the stamp does indicate that the patient was seen at the National Institutes of Health’s Clinical Center

“We have learned that 2 patients were enrolledthrough the Clinical Center and hence … the Clinical Centerhas medical records for those 2 individuals”
——————————————————————
6/6/1995 we know from Dr. Michael A. Friedman’s letter that “2 patients were treated at the National Cancer Institute” [1]

8/23/1995 we know that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients per National Institutes of Health (NIH) Legal Advisor Robert B. Lanam’s letter [2]

8/23/1995 we know that Dr. Michael A. Friedman was copied on Robert A. Lanman’s letter which stated that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients [2]

9/19/1995 we know that Dr. Michael A. Friedman advised that “We have no individual patient records in our possession …” in his letter to Burzynski [3]

10/5/1995 we know that Robert B. Lanman admitted that ” … the National Institutes of Health’s Clinical Center … has medical records for those 2 individuals”, in his letter [4]

All Americans are “presumed to know the law”, so we know that Dr. Michael A. Friedman would have advised Robert B. Lanman if his 8/23/1995 written statement to Burzynski’s attorney, Richard A. Jaffe, Esq., was NOT TRUE [2], and / or would have advised Burzynski in his 9/19/1995 letter that the National Cancer Institutes Clinical Center had “medical records for those 2 individuals” [3]

20130918-154926.jpg
Dr. Michael A. Friedman

6/6/1995 you advised Burzynski that “2 patients were treated at the National Cancer Institute” [1]

8/23/1995 you were copied on Robert A. Lanman’s letter which stated that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients [2]

8/23/1995 we know that you did NOT advise Burzynski that National Institutes of Health (NIH) Legal Advisor Robert B. Lanman’s written statement was NOT TRUE [2]

9/19/1995 you advised Burzynski that “We have no individual patient records in our possession …” [3]

10/5/1995 – Robert B. Lanman admitted that ” … the National Institutes of Health’s Clinical Center … has medical records for those 2 individuals” [4]

Dr. Michael A. Friedman, I know that you would NOT break the law

Title 18, Part I, Chapter 47, § 1001

18 USC § 1001 – Statements or entries generally

(3) “makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry”

Dr. Michael A. Friedman, please let me know why what you did was NOT a LIE

My primary obligation is to the American public, because, I know you would tell the TRUTH, since, in your words, you “could not responsibly act in any other manner”
======================================
[0] – Title 18, Part I, Chapter 47, § 1001

18 USC § 1001 – Statements or entries generally
——————————————————————
http://www.law.cornell.edu/uscode/text/18/1001
======================================

[7] – 1993 (10/20/1993) – Dr. Michael A. Friedman to Burzynski (4 pgs.)

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
======================================
[7] – 1993 (10/20/1993) – Dr. Michael A. Friedman to Burzynski (4 pgs.)

Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment, National Cancer Institute (NCI), Department of Health & Human Services (HHS), National Institutes of Health (NIH) letter to Burzynski [4 Pgs.]

Dear Dr. Burzynski:

This letter is in response to your correspondence of 10/11/1993

(addressed to Dr. Sznol)

and of 10/13/1993

(to Dr. Greenblatt)

Your most recent comments regarding the approved study of antineoplastons in adults brain tumor patients, faxed to Dr. Greenblatt on 10/13/1993, come as quite a surprise

Particularly confusing are your comments regarding dose and schedule of antineoplastons proposed in that study (your comment #1)

Originally the dosage and schedule for this study was based on your protocol BT4

This version of BT4 was entitled,
“Therapy of high-grade glioma with continuous infusions of antineoplastons A10 and AS2-1”,
and was accompanied by 12 case histories

(patients with either anaplastic astrocytoma or glioblastoma multiforme treated apparently according to BT4)

In your letter of 4/26/1993, however you stated that protocol BT4 was only for low-grade gliomas

Furthermore, you noted that protocols BT5 or BT6 should be used for patients with anaplastic astrocytoma and gliobastoma multiforme

In that same letter (4/20/1993), you noted that AS 2-1 was tolerated well at doses of .5 gm/kg/24h by adult patients when administered in intermittent injections (this is method of administration in BT6 and in the IND study)

You stated that if given by continuous infusion, adults would experience increased sleepiness and tiredness, and specifically stated that the dosage of AS2-1 by continuous infusion for low-grade gliomas should be reduced to 0.4 g/kg/24h

You did not provide data to support these assertions, nevertheless, based on these comments and our review of the protocols BT4, BT5, BT6, we instructed the investigators to revise their protocol in accordance with your instructions

In the Consensus Review sent 5/5/1993, we instructed the Memorial Sloan Kettering investigators to pattern their protocol according to BT5, which was written for both children and adults
We specifically pointed out that BT6 was written for children

In your letter of 6/9/1993, regarding our Consensus Review, you specifically asked that the investigators use the treatment program according to BT6, knowing that the Memorial protocol was for adults with AA and/or GM

You did not at any time mention that dose escalation should be modified for adults, or mention any dose limitation for adults given the intermittent as specified in the BT6 protocol

Page 2

Your concerns regarding dose limitation in the previous letter appeared to be related to continuous infusion administration

The letter of 6/9/1993, contained only 4 comments and at that time you had both the protocol and Consensus Review in your possession

We transmitted your letter of 6/9 directly to the investigators, and all your requested changes were made

Our sincere efforts to attempt to duplicate your findings and follow your recommendations are frustrated by receiving contradictory, incomplete, and inconsistent information from you

We have, at multiple points in the protocol development, solicited your input and followed your guidance in getting recommended dose escalation and modification guidelines for adults

Please note that, one last time, we will ask the investigator to revise the protocol with regard to dose and schedule in compliance with your latest letter

However, we plan that the study will begin immediately and this will be the last such modification

Although you have not provided data to support each of your specific recommendation, we have incorporated them

With regard to comment #2 of your Fax of 10/13/1993, you have misinterpreted the protocol

The total number of potential patients is 35/stratum, (ie a total of 70 patients) allowing for an adequate Phase II evaluation of each group of patients

With regard to the statistical section, your #3 comment, there is little reason to assume that the modified Fleming design currently used in the protocol for the first stage of accrual is less appropriate than a design using 15 patients in the first stage

If the true response rate of the antineoplastons is 20% (standard criteria for activity in all our phase II trials considered worthy of further study), the chance of proceeding to the second stage of accrual with the current design is 93.1%

The chance of proceeding to the second stage using 15 patients in the first stage of accrual is 96.5%

These differences are not considered meaningful

With regard to your comment #4, we wish to maintain the standard clinical trials methodology used to evaluate new agents

We know of no evidence that obtaining a brain scan within 7 days of treatment versus within 14 days of treatment will in any way affect the evaluation of activity of a drug in this disease

The protocol clearly states that scans must be obtained within 2 weeks of study entry

Please also note that the practical difficulties in scheduling scans and completing the pretreatment work-up in just one week; the costs of repeating tests simply to meet this artificial deadline could not be justified and probably would not be covered by insurance companies

With regard to your point #5, (performance status) your own protocols allow patients with Karnofsky performance status of 60

We see no reason to demand a more stringent entry criteria for performance status than you have employed for your own patients

Page 3

With regard to your point #6, the use of neurologic status as well as CT scans/MRI findings to determine response, this was suggested to the investigators in our Consensus Review of 5/5/1993

You made no comment regarding this in your letter of 6/9/1993

This use of neurologic function as an additional criteria to determine response is an objective measurement and is standard among protocols we sponsor for glioma patients . .

It is scientifically acceptable to include the criteria for response as currently written in the protocol

At analysis, both scan data and objective neurologic assessment can be described

With regard to your letter of 10/11/1993, concerning data reviews, we are satisfied that reviewing the data after accrual of the first 14 patients/stratum is sufficient

We share your concerns about patient safety but believe that these investigators have extensive experience treating glioma patients, are superb and careful physicians, and have extensive experience administrating a range of investigational agents to these patients

Furthermore, the patients will be followed carefully, and dose reductions for expected toxicities will be carried out as specified in the protocol

Nevertheless, your experience with the agents is valuable and the availability of your guidance is much appreciated

If necessary, we will arrange a conference call at the end of treatment of the first 5 patients, or sooner if problems occur

Your participation in such a conference call, if necessary, would be welcome

We will provide the Theradex (CTMS) printout to you on a monthly basis as we receive it

We do not believe it is practical or necessary to supply data on an every 2 week basis

The most important unresolved issue at this time is that we are still waiting to receive the promised supply of antineoplastons to conduct these studies

Your letter of 11/5/1992, guaranteed a supply of the antineoplastons by 3/31/1993

(see attached)

As of today we still have not received it

Believing that you would be shipping drug to the NCI, and since the protocol is approved at Memorial Sloan Kettering, recruitment of patients has begun

As you point out, these patients have aggressive disease, and cannot afford to wait to begin treatment

We are prepared to try to assist you in meeting this commitment, but we know of no obstacle here at NCI

We urgently request, again, that you ship the drug immediately

Please be aware that our mission is to find and develop better therapies for cancer patients, and our only obligation is to those patients

Our agreement to pursue these studies with antineoplastons was based on suggestive evidence

Page 4

of activity noted in your best case studies

If you are unable or unwilling to provide the antineoplastons in the near future, we will pursue alternative sources to procure the drug or its active components, and will proceed with a clinical development plan to determine whether these chemicals have activity and are beneficial for patients

Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program, Division of Cancer Treatment, NCI, Department of Health and Human Services, National Institutes of Health

cc:

Dr. Samuel Broder
Dr. Jan Buckner
Dr. Bruce Chabner
Dr. Jay Grabnett
Dr. Joseph Jacobs
Dr. Mark Malkin
Ms. Mary McCabe
Dr. David Parkinson
Dr. Mario Sznol
Ms. Dorothy Tisevich
——————————————————————

======================================
1993 (10/20/1993) – Dr. Michael A. Friedman to Burzynski [8]
1992 (11/5/1992) – Burzynski ANP 3/31/1993
1993 (4/20/1993) – Burzynski (4/26/1993)? in that same letter
1993 (4/26/1993) – Burzynski
1993 (5/5/1993) – Consensus Review
1993 (6/9/1993) – Burzynski re Consensus Review
1993 (10/11/1993) – Burzynski to Dr. Mario Sznol
1993 (10/13/1993) – Burzynski fax to Dr. Jay Greenblatt
======================================

Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 8)

onforb.es/11pwse9

http://t.co/vh3cgAR6hW

http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics
Didymus Judas Thomas, Contributor

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 1 week ago

“Erm, what conflict of interest?”

FW (also known as @frozenwarning), your “conflict of interest” with “facts”

Do you know how utterly, completely, fruit looping bonkers that is?

Seriously, get a grip.

FW 1 week ago

“Sadly Burzynski isn’t following FDA standards, as their warning letters and current inspection shut down proves.”

FW, being from the United Kingdom, are you even knowledgeable about the FDA warning letter process?

“He’s been doing his “research” for 40 years.”

“How long do you think he should be allowed to continue without showing his data?”

FW, what do you call THIS ?

Burzynski Clinical Trials (The SEC filings)
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2
“As I said earlier, the Phase 3 trial has been registered since 2010 and Burzynski shows no inclination to start it, having NOT A SINGLE PATIENT RECRUITED.”

FW, as I said earlier, did you pay attention to this?

Burzynski: Not every cancer clinical trial taking place in the United States is listed on our NCI clinical trials database
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-not-every-cancer-clinical-trial-taking-place-in-the-united-states-is-listed-on-our-nci-clinical-trials-database
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

” … 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”

why was the FDA requiring “radiation
” in the phase 3 clinical trial?

“I’ll tell you what these patients lose, they lose time, and quality of life, and hundreds of thousands of dollars on an unproven therapy that they are being misled about, and no-one in that situation deserves that.”

FW, isn’t EVERY drug in the clinical trial process “unproven therapy,” until such time as the FDA approves it?

Are you saying that because EVERY drug in the clinical trial process is “unproven therapy,” there should be NO clinical trials AT ALL?

FW 1 week ago

“Hah, if the FDA took any notice of the criticism, then I’m glad to hear it, though if Burzynski had not conducted his trials in an unethical and unscientific way, which was obvious merely from what his patients reported, they would have had no reason to shut his operation down.”

FW, what information do you have from the FDA that supports your comments?

“Why continue?”

“Well, there’s the so called gene targeted therapy that he still peddles for vast amounts of money, which isn’t gene targeted at all, merely a way of selling random scattergun, often off label chemotherapy.”

FW, where are your reliable independent sources (citation(s), reference(s), and / or link(s)?

“There are no retainers, that’s another of your usual batshit theories, used instead of answering the questions.”

FW, I’m still waiting for you to answer my questions

“Classy of you to use my family bereavements in such a way though.”

“I can assure you, they got the best care available and luckily no quack ever tried to con them. If they had, they would have got short shrift.”

FW, so, unfortunately, even though your family “got the best care available,” they still passed?

Which also happens to Burzynski

rjblaskiewicz 1 week ago

“Damn it, Eric. Wouldn’t your time be better spent recutting your movie so it didn’t suck?”

rjblatherskiewicz, I don’t see you on here with your lame comments:

Have you heard of Anthony Jeselnik’s “Defend Your Tweet?”

I’d like to find out how you’d “Defend Your Comments”

My Critique of Bob Blaskiewicz (Colorado Public Television – PBS CPT12)
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/my-critique-of-bob-blaskiewicz-colorado-public-television-pbs-cpt12
Critiquing Bob Blaskiewicz (#Burzynski Cancer is Serious Business, Part II)
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/critiquing-bob-blaskiewicz-burzynski-cancer-is-serious-business-part-ii
Boris Ogon 1 week ago

(citing Astroturfwatch’s comments):

“They refuse to fact check anything. Namely Phase 2 results showing a 25% cure rate for brainstem glioma, never accomplished in medical history—ever.”

“Published plan as day in a ‘internationally peer-reviewed’ article.”

(Boris Ogon)

“You mean PMIDs 12718563 and 16484713? (These, at least, are the ones that Merola cites, which I assume is the sum total of your “fact checking.”)”

Mr. Ogon, I don’t see any comments from “Merola” on the Forbes comments, but maybe you are referring to Astroturfwatch’s comments:

“Namely Phase 2 results showing a 25% cure rate for brainstem glioma, never accomplished in medical history—ever”

“Notice the chart on page 172 (page 8 of PDF).”

“Find just one, any single cure for this tumor type and you can’t, outside of Antineoplastons FDA sanctioned clinical trials:”
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf
(Boris Ogon)

“Let’s take them in turn, noting first that

“(1) neither represents the results of a completed Phase 2 trial and”

“(2) it’s essentially the same group in both.””

“We know the following about the ultimate group of 13:”

““Medulloblastoma was diagnosed in 8 patients, pineoblastoma in 3 patients, and other PNET in 2 patients.”

“Prior therapies included surgery in 12 patients (1 had biopsy only, suboccipital craniotomy), chemotherapy in 6 patients, and radiation therapy in 6 patients.”

“Six patients had not received chemotherapy or radiation.”

“The first reference is to Drugs in R&D 4:91 (2003).”

“This is a pharmacy journal, which immediately calls into question the adequacy of the available peer review.”

“It also appears to have briefly gone out of business, with no articles published in 2010.”

“Its JCR IF for 2009 was 1.354, which represented an increase of “more than 35%” of 2008; it did not even have an IF in 2011, but in this year, it was ranked 114 out of 221 in its SCImago category, *after* it had switched to “Gold OA,” which may well lead one to wonder whether it was even a third-tier journal earlier on.”

“The side effects included anemia, hypernatremia, agranulocytosis, and granulocytopenia.”

“End result?”

“The results of this study compared favourably with the responses of patients treated with radiation therapy and chemotherapy.”

“Color me unimpressed.”

“This gets better with the next one, though.”

“The second reference is to Integrative Cancer Therapies 4:168 (2005).”

“One may suspect from the title that we may have a problem here.”

“A look at the current editorial board leaves one distinctly unimpressed.”

“In particular, it includes *Ralph Moss.*”

“If this name doesn’t immediately set of a warning klaxon in your head, you’re not familiar with cancer crankery.”

“With a 2011 IF of 2.136, it currently ranks 118 of 196 in the JCR oncology category.”

“It shared this number with papers about acupuncture and green tea, but let’s cut to the chase:”

“The percentage of patients’ response is lower than for standard treatment of favorable PNET.”

“That’s right, “antineoplastons” did *worse* than standard treatment.”

“He tries to salvage something from this mess by suggesting that “antineoplastons” might someday prove useful for some categories of PNETs.”

“*Neither* paper claims superiority over conventional treatment.”

Mr. Ogon, where did you get your data from?

The “chart on page 172 (page 8 of PDF):”
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf
refers to:

2006 Adis – Pediatr Drugs 2006; 8 (3)

pg 172

Treatments for Astrocytic Tumors

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.”

27% – CR – Complete Response
20% – PR – Partial Response
23% – SD – Stable Disease
30% – PD – Progressive Disease
[12,88]

pg 175

12. Burzynski SR Targeted therapy for brain tumors In: Columbus, F editor. Brain cancer research progress. New York: Nova Science Publishers Inc 2005

pg 173

10 evaluable children
aged <4 years diagnosed with DBSG treated with ANP
youngest 3-month-old infant
[89]

60% – 2-year survival rate
20% – 5-year survival rate
maximum survival more than 7 years

30% – CR – Complete Response
40% – SD – Stable Disease
30% – PD – Progressive Disease
[89]

“The results are compiled in table II.”

pg 174

2.3. Targeted Therapy

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

“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.””

Mr. Ogon, did you read THIS ?

Burzynski: STABLE DISEASE
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-stable-disease
5/2007 – Guidance for Industry – Food and Drug Administration
Guidance for Industry

Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics

U.S. Department of Health and Human Services Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

May 2007 Clinical/Medical

“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)”
(Pg. 11 of 22 = actual pg. 8 of PDF)

Time to Progression and Progression-Free Survival

TTP – Time to Progression

PFS – Progression-Free Survival

Time to Progression and Progression-Free Survival

TTP and PFS have served as primary endpoints for drug approval

TTP and PFS have served as primary endpoints for drug approval
(Pg. 11 of 22 = actual pg. 8 of PDF)

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.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)

http://www.ncbi.nlm.nih.gov/m/pubmed/15565574
St. Jude Children’s Research Hospital (Memphis, TN)
29 (88)
Texas Children’s Medical Center (Houston, TX)
2 (6)
Children’s Medical Center (Dallas, TX)
2 (6)
Cancer. 2005 Jan 1;103(1):133-9
Cancer 103, 133-139
Cancer Volume 103, Issue 1, pages 133–139, 1 January 2005
DOI: 10.1002/cncr.20741
Article first published online: 24 NOV 2004
American Cancer Society

http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/full
“Protip:”

“Before you start crying about how “‘fact-checking’ is no longer even on the table,” you might want to try figuring out what it actually is first.”

Mr. Ogon, what was that about

“fact-checking” ?

Lynne 1 week ago

“Angel of life, let me point out that there are many accounts of brain cancer survivors who were treated with conventional medicine.”

“Burzynski is not the only one.”

“A simple google search reveals that there are several cancer survivor groups and other accounts of healing via traditional scientific medicine.”

“Just one example:”

“virtualtrials.org”

“(go to the bottom of the page and click on survivor stories)”

“features 37 brain cancer patients who have survived from 5-30 years by choosing cutting edge research and clinical trials.”

“Their stories are identical to those of Burzynski patients.”

“Some people are just fortunate in their response to chemo, and make no mistake, Burzynski uses chemo.”

“There are a lot more examples out there.”

“Burzynski has not shown conclusively that he has a higher survival rate than conventional medicine, which would be so easy for him to do.”

Lynne, did you look HERE ?

Burzynski Clinical Trials (The SEC filings):
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2
“He could post it tomorrow; it doesn’t have to be in a peer reviewed journal.”

Lynne, at least you’re right about that:

Burzynski: What happens when a clinical trial is over?
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-what-happens-when-a-clinical-trial-is-over
“Instead, we are asked to just believe him because he’s such a nice guy who cares so much.”

Lynne, that’s one way to do it:

Burzynski: Declaration of Helsinki
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-declaration-of-helsinki
“To complete the equation, you have to know the denominator:”

Lynne, that’s another option:

Burzynski: FAQ: Clinical Trial Results
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-faq-clinical-trial-results/
“how many didn’t make it.”

Lynne, you could ask that too:

Antineoplastons: Has the FDA kept its promise to the American people ?
https://stanislawrajmundburzynski.wordpress.com/2013/03/22/antineoplastons-has-the-fda-kept-its-promise-to-the-american-people
“Conventional medicine is transparent and reports failures.”

Lynne, if you say so, though you provide no citation(s), reference(s), and / or link(s):

Burzynski: The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-the-fdas-drug-review-process-ensuring-drugs-are-safe-and-effective
“Burzynski doesn’t.”

Lynne, if you say so:

Burzynski – The Antineoplaston Randomized Japan Phase II Clinical Trial Study:
https://stanislawrajmundburzynski.wordpress.com/2013/03/28/burzynski-the-antineoplaston-randomized-japan-phase-ii-clinical-trial-study
“Just another reason the body of scientists don’t find him credible.”

Lynne, like THESE ?

Burzynski referenced by other Cancer researchers:
https://stanislawrajmundburzynski.wordpress.com/2013/04/24/burzynski-referenced-by-other-cancer-researchers
Boris Ogon

“You are right now having a live “debate” in front of more than 10,000 people, … “

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”

Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 1)

http://t.co/vh3cgAR6hW

onforb.es/11pwse9

http://t.co/vh3cgAR6hW

http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics
Didymus Judas Thomas, Contributor

Musings on the intersection of Articles, Bias, and Censorship

(The Big 3: A.B.C.)

4/19/2013 @ 9:43PM

rjblaskiewicz 1 week ago

(@rjblaskiewicz a/k/a Blatherskitewicz)

Mr. R.J. Blaskiewicz, is well known as:

“Bob Blaskiewicz, Faux Skeptic Exposed!”

There are numerous Internet pages and great pictures of him re Atlanta, Georgia, where he was called out, but hid behind his keyboard:

Sep 17, 2011 – Bob Blaskiewicz, Faux Skeptic Exposed!
http://www.wearechangeatlanta.com/2011/09/17/censorship-of-911-truth-by-ga-tech-professor-bob-blaskiwieckz
Bob Blaskiewicz, Faux Skeptic …
Oct 6, 2011

http://www.theprogressivemind.info/?p=71064
Skeptical Humanities
Jun 23, 2011 – Bob Blaskiewicz, Faux Skeptic Exposed
http://skepticalhumanities.com/2011/06/23/sneak-preview-of-things-to-come
September 21 …
Bob Blaskiewicz, Faux Skeptic …
CLASSIC PICTURE
http://www.wearechangeatlanta.com/tag/justice
Sep 17th, 2011
blaskiewicz
“blaskiewicz”. Bob Blaskiewicz, Faux Skeptic Exposed!
CLASSIC PICTURE
http://waca.wisemantis.com/tag/blaskiewicz
September …
Bob Blaskiewicz, Faux Skeptic …
Sep 17th, 2011
CLASSIC PICTURE
http://www.wearechangeatlanta.com/category/articles
guychapman 5 days ago

(@ScepticGuy @vGuyUK)

Mr Chapman leads “The Skeptics” with his 18 comments, revealing the BIAS of the Article, from his UK “blahg”
http://www.chapmancentral.co.uk/blahg
Mr. Chapman is best known for referring to people as “C*NTS”

Author

Peter Lipson, Contributor 1 week ago

(@palMD)

Dr. Lipson is best known for his outstanding “superficial” research re this Article, and its BIASED “ethically-challenged” and “fact-challenged” writing style
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/dr-peter-a-lipson-and-or-his-censors-is-a-coward-critiquing-a-film-producer-a-cancer-doctor-and-their-critics
4/23/2013
https://stanislawrajmundburzynski.wordpress.com/2013/04/23/forbes-censors-peter-lipson-speech-is-best-countered-by-more-speech-article-comments
4/20/2013
https://stanislawrajmundburzynski.wordpress.com/2013/04/20/a-film-producer-a-cancer-doctor-and-their-critics
rjblaskiewicz 6 days ago

Mr. Blaskiewicz makes the comment:

“You are wrong. But you know this.”

Which aptly describes him:
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/critiquing-bob-blaskiewicz-burzynski-cancer-is-serious-business-part-ii
3/26/2013
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/my-critique-of-bob-blaskiewicz-colorado-public-television-pbs-cpt12
guychapman 5 days ago

Mr. Chapman commented:

“What it does not include is the results from any one of the 61 registered trials on human subjects since 1996.”

Which goes to show that he does NOT know the subject-matter:

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)

2 – Terminated (Withdrawn due to slow enrollment)
7 – Withdrawn (This study has been withdrawn prior to enrollment)

The above 9 studies were NOT even started, which means that there would NOT be any “results” for them

1 – Not Yet Recruiting (Open)(Phase 3)
10 – Recruiting (Open)
11 – Open (1 Not Yet Recruiting / 10 Recruiting)

The above 11 studies had NOT even started, so there would also NOT be any results for them

That’s 20 subtracted from the 61, right there, leaving 41

Mr. Chapman goes on to state:

“Even without the fact that charging for participation in trials is unusual to say the least, the failure to publish any usable results from any single trial is grossly unethical.”

Mr. Chapman does NOT provide any information as to how clinical trials are to be run without charging for them, or any information as to how much the clinical trials cost

Mr. Chapman is just another “voice crying in the wilderness,” who complains, but does NOT provide any solution(s); which is so very “last century”

Mr. Chapman continues:

” … the failure to publish any usable results from any single trial is grossly unethical.”

Mr. Chapman does NOT provide any information from the United States Department of Health and Human Services (HHS), U. S. Food and Drug Administration (FDA), National Cancer Institute (NCI) at the National Institutes of Health (NIH), Declaration of Helsinki, or any other source, that supports his statement
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-what-happens-when-a-clinical-trial-is-over
Burzynski: Declaration of Helsinki:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-declaration-of-helsinki
“Trial results are not always publicly available, even after a clinical trial ends:”
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-faq-clinical-trial-results/
Burzynski: What happens when a clinical trial is over?
“National Cancer Institute (NCI) at the National Institutes of Health (NIH), Cancer Clinical Trials, 15. What happens when a clinical trial is over?,” advises:
“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 … ”
This makes it clear that clinical trial results “are OFTEN” published, but sometimes they are “NOT” published “in a peer-reviewed scientific journal”
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-what-happens-when-a-clinical-trial-is-over
Mr. Chapman does NOT seem to be able to grasp the American concept of “citation(s), reference(s), or link(s) to any independent reliable source

guychapman 5 days ago

Mr. Chapman posits; with his usual verbosity, in his “lame duck” attempt at masking his ignorance on the subject and hoping that, as the court stated:

“The U.S. v. Article’~ court stated that the FDA’s responsibility was to protect the ultimate consumer, which included protection of “the ignorant, the unthinking and the credulous.”‘

… that he will be able to overwhelm:

“the ignorant, the unthinking and the credulous.”‘

with the amount of verbiage he was allowed to ejaculate

Mr. Chapman states:

“I am puzzled by your schizophrenic attitude to the FDA though.”

Mr. Chapman does NOT want to touch this below with the proverbial

“10 Foot Pole:”

Burzynski: Managing social conflict in complementary and alternative medicine research: the case of antineoplastons
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-managing-social-conflict-in-complementary-and-alternative-medicine-research-the-case-of-antineoplastons
Documents/BurzynskiTriesToExposeNCI.pdf
http://burzynskimovie.com/images/stories/transcript/Documents/BurzynskiTriesToExposeNCI.pdf
Mr. Chapman, why was the FDA requiring “radiation” in the phase 3 clinical trial?

” … 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”

Mr. Chapman continues:

“It seems to me that actually the FDA are 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.”

Mr. Chapman, again, does NOT provide any support for his statement
https://stanislawrajmundburzynski.wordpress.com/2013/03/27/my-critique-of-oracs-stanislaw-burzynski-versus-regulations-protecting-human-research-subjects-revisited
To use Mr. Chapman’s own words back at him:

“I can’t think of anyone else in that position.”

The dishonesty of Guy Chapman, “The Skeptics” shill
https://stanislawrajmundburzynski.wordpress.com/2013/04/12/the-dishonesty-of-guy-chapman-the-skeptics-shill
Krista Cashatt 6 days ago

“What an amazing amount of disinformation and propaganda concerning Burzynski…hope you get some money in the deal”

What she said

Boris Ogon 6 days ago

“You are right now having a live “debate” in front of more than 10,000 people, … ”

3,581 views

Not so much

Waiting for the 10,000

4/19/2013 @ 9:43PM
Peter Lipson: “Speech is best countered by more speech”

Burzynski: Department of Health and Human Services: OFFICE OF INSPECTOR GENERAL-THE FOOD AND DRUG ADMINISTRATION’S OVERSIGHT OF CLINICAL TRIALS

Daniel R. Levinson Inspector General
September 2007 OEI-01-06-00160

75% of inspections target previously completed trials and often focus on verifying quality of clinical trial data

75% of BiMo inspections during FY 2000–2005 period were surveillance inspections, which generally target previously completed trials and often focus on verifying quality of clinical trial data
https://oig.hhs.gov/oei/reports/oei-01-06-00160.pdf