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

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[1] – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
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BB – Bob Blaskiewicz
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DJT – Didymus Judas Thomas
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0:47:00
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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”
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0:48:00
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0:53:00
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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
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0:54:02
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BB“I, I just find that to be contradictory and and self-defeating
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DJT – Bob, exactly where did I invoke “the FDA as being obstructionist” ?
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1:02:00
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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
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1:03:00
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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”
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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” ?
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1:04:02
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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
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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]
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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
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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
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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]
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1:05:00
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1:42:00
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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”
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DJT – Bob, who initiated and put into place the clinical trial hold ?

Burzynski ?

FDA ?

Both ?
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1:43:30
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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
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1:44:00
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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”
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Bob, where are the “final reports” for those “3 reviews” ?
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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”
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DJT – Bob, Burzynski has provided numerous phase 2 clinical trial preliminary reports, which our #fave oncologist has chosen to ignore [4]
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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
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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]
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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”
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DJT – Well, how have I been speculating ?
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1:46:00
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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 ?”
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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”
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DJT – what the journals keep saying, in response
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BB“What ?”
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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” ?
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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”
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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
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1:47:06
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DJT – Not that he’s been practicing medicine medicine for 36 years, or whatever, it’s when the clin, clinical trial was done
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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”
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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]
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DJT – The FDA A believes there is evidence of efficacy
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BB – “Perhaps based on bad phase 2”
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DJT – Well, we don’t know that

We don’t have the Freedom of Information Act information
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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 ?
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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”
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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
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1:48:01
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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 ?
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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
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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” ?
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BB – “He’s changed things”
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DJT – Eric said they gave
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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”
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DJT – We’ll I’m
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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”
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1:49:02
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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”
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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]
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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]
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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”
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1:50:00
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BB – “He should have access to this”

“We can’t get it”
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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]
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BB – “How how long will it take before you recognize that, nothing is forthcoming ?”

“How long would that take ?”
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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
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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”
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1:51:00
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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 ?”
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Bob, do you want to have a contest to determine which of you is more “reliable” ?
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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]
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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”
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1:52:00
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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
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BB – “Where has Eric been wrong ?”
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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
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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
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1:53:05
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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
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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”
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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
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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
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1:54:16
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BB“Um”
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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
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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”
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1:55:08
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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”
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1:56:02
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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”
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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
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1:57:10
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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”
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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”

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

“Massive amounts of data are required”
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Bob, do you think that’s the 2.5 million pages of clinical trial data that Fabio said Burzynski sent to the FDA ? [10]
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2:02:00
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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
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Bob, exactly where did I exhibit any “kind of back-peddling” ?
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2:03:03
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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”
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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
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2:04:11
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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 ?”
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DJT – How did I say I, I didn’t trust them ?
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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
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2:05:12
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BB – “You’re suggesting that they’re untrustworthy”
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DJT – No, I’m just sayin’ that I’ve raised questions and none of The Skeptics wanna to uh talk about ‘em [11]
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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 ?”
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Bob, would that “researcher” be Dvorit D. Samid, who was in Burzynski: Cancer is Serious Business (Part I) ?
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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
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BB“Yeah, the the the it wasn’t the FDA who was pressing charges, it was a Federal prosecutor
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DJT – Right
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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”
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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
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2:10:15
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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”
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DJT – Well, I think The Skeptics, Skeptics are falling short because, you know, they don’t own up to
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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”
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2:11:02
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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”
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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
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BB“Why wasn’t that study”
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DJT – for me to make up my mind (laughing)
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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 ?
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2:12:05
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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
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BB“Why was the Mayo”

“Why was the Mayo (Correction: M.D. Anderson) study delayed ?”
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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 ?
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BB“Well you said you had so many years before you finish it and go in”
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DJT – I mean, has anybody
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BB“Why, why did it take so long ?
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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
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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”
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DJT – Sure
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BB“Um, because, I can ask that question of those researchers, why was this study in this time, and what happened in-between”
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2:13:03
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BB – “Why did it take so long for it, for it to come out”
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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
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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
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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”
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2:14:07
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BB“I I, yeah, the other thing that David James points out is you know, why 2016 when he’s had 36 years already ?
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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/
======================================

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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 ?
=======================================

[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: Aetna: Antineoplaston Therapy and Sodium Phenylbutyrate

[1] – Aetna, Clinical Policy Bulletin: Number: 0240 Policy claims:

Aetna considers antineoplaston therapy (auto-urine therapy) and associated medical services experimental and investigational because there is insufficient evidence published in the peer-reviewed medical literature validating the effectiveness of antineoplaston therapy for any indication
====================================
Interestingly, the above “claim” does NOT provide any specific citation(s), reference(s), or link(s) to support this claim

[2] – “auto-urine therapy” is generally defined as using one’s own urine, drinking urine, etc., which is NOT what “antineoplaston therapy” is, according to the National Cancer Institute (NCI) at the National Institutes of Health (NIH)
——————————————————————
[3] – 10/4/1991 – Five doctors (3 from the Cancer Therapy Evaluation Branch (CTEP); including the Head of the Quality Assurance and Compliance Section, Regulatory Affairs Branch, Cancer Therapy Evaluation Program, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, and 2 invited consultants; including one from the National Institutes of Health (NIH) Clinical Center) visited the offices of Dr. Stanislaw R. Burzynski
——————————————————————
[4] – 10/31/1991 – Michael A. Friedman, M.D. Associate Director, Cancer Therapy Evaluation Program (CTEP), Department of Health &Human Services, National Institutes of Health, National Cancer Institute, sent a one page Memorandum to Bruce A. Chabner, M.D., Director, Division of Cancer Treatment, which stated, in part:

“I thought you would be interested in this for several reasons:”

“3. Antineoplastons deserve a closer look”

“It turns out that the agents are well defined, pure chemical entities
=======================================
=======================================
“The human brain tumor responses are real”

20130911-102213.jpg
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[5] – 11/15/1991 – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, sent a 7 page letter to Decision Network, which stated, in part, on page one:
=======================================
=======================================
“It was the opinion of the site visit team that antitumor activity was documented in this best case series … “

20130911-122216.jpg
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[6] – 12/2/91 – NCI (National Cancer Institute), Decision Network Report on Antineoplastons, states in part, on page 11:

20130911-134634.jpg
=======================================
“The site visit team determined that antitumor activity was documented in this best case series … “
=======================================
=======================================
[7] – CANCER FACTS
National Cancer Institute • National Institutes of Health Department of Health and Human Services, Antineoplastons, pg. 1

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=======================================
“The reviewers of this series found evidence of antitumor activity … “

20130911-094155.jpg
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[8] – Page 1 of 6, BlueCross BlueShield of Alabama, Antineoplaston Cancer Therapy, Policy #: 280, Category: Medicine, states, in part, on page 2 of 6:

Key Points:
=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “
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[9] – ANTINEOPLASTON THERAPY, HS-183, pg. 2
=======================================
=======================================
“After the reviewers found some evidence of antitumor activity … “
=======================================
=======================================
These facts indicate to me that Aetna’s claim about “antineoplastons”, is “debatable”

Maybe they should have learned how to use the Freedom of Information Act (FOIA)
=======================================
REFERENCES:
=======================================
[1]
——————————————————————
http://www.aetna.com/cpb/medical/data/200_299/0240.html
=======================================
[2]
——————————————————————
http://m.cancer.gov/topics/CAM/antineoplastons/Patient
——————————————————————
http://cancer.gov/topics/CAM/antineoplastons/Patient
——————————————————————
http://cancer.gov/topics/CAM/antineoplastons/Patient?print=1
——————————————————————
http://m.cancer.gov/topics/CAM/antineoplastons/Patient?print=1
=======================================
[7]
——————————————————————
http://www.emory.edu/KomenEd/PDF/Treatment/Antineoplastons.pdf
=======================================
[8]
——————————————————————
https://www.bcbsal.org/providers/policies/final/280.pdf
=======================================
[9]
——————————————————————
https://www.wellcare.com/WCAssets/corporate/assets/HS183_Antineoplaston_Therapy.pdf
=======================================

Critiquing: Wikipedia – Burzynski Clinic

[1] – Wikipedia, claims:
——————————————————————
“There is a scientific consensus that antineoplaston therapy is unproven and of little promise in treating cancer””
——————————————————————
“… a Mayo Clinic study found no benefit from antineoplaston treatment.[1]””
——————————————————————
“The Memorial Sloan-Kettering Cancer Center has stated: “Bottom Line: There is no clear evidence to support the anticancer effects of antineoplastons in humans.”[1]””
——————————————————————
Interestingly, the above 1st claim by “Wikipedia” does NOT provide any specific citation(s), reference(s), or link(s) to support this claim
——————————————————————
[2] – 2/1999 – What “Wikipedia” does NOT advise the reader about the 2nd and 3rd claims, is that the conclusion of the study was:

“Although we could not confirm any tumor regression in patients in this study, the small sample size precludes definitive conclusions about treatment efficacy
——————————————————————
[3] – 6/1999 – Wikipedia also does NOT point out that Burzynski replied to the 2/1999 publication, that:

[A] – Study tested dosing regimen known to be ineffective

[B] – Dosages of A10 and AS2–1 used in study were meant for treatment of single small lesion (<5 cm)

5 of the 6 evaluable patients had either multiple nodules or tumors larger than 5 cm

[C] – As the provider of A10 and AS2–1, I strongly suggested to the National Cancer Institute (NCI) that these patients receive a much higher dose, consistent with greater tumor load

[D] – Study was closed when I insisted the NCI either increase the dosage or inform the patients that the drug manufacturer believed that the treatment was unlikely to be effective at the dosages being used
(letter to Dr M. Sznol, NCI, on 4/20/1995)

[E] – Review of clinical data in the article by Buckner et al proves validity of my position

[F] – Study patients had extremely low plasma antineoplaston levels

My phase 2 study dosage regimen produced plasma phenylacetylglutamine (PG) levels 35 times greater, phenylacetylisoglutamine (isoPG) levels 53 times greater, and phenylacetate (PN) levels 2 times greater than those reported by Buckner et a1 [1]

[G] – Clinical outcomes reported by Buckner et al, based on inadequate dosage schedule, differ dramatically from my phase 2 studies in which higher dosage regimen was used

[H] – They reported no tumor regression

In contrast, in 1 of my ongoing studies on protocol BT-9, 4 of 8 evaluable patients with astrocytoma had objective responses [2]

[I] – Difference in outcomes primarily due to difference in dosage schedules

[J] – Another factor that may have caused a lack of response in the study by Buckner et al is duration of treatment was too brief

Almost all patients in their study received treatment for less than 30 days

1 patient received only 9 days of treatment

Current studies indicate objective tumor responses usually observed after 3 months of therapy

Additional 8 months of treatment usually needed to obtain maximal therapeutic effect

[K] – Ambiguities in response evaluation and analysis in article by Buckner et al

In.2 patients, tumor necrosis attributed to “radio-necrosis”

Interpretation’s clouded by fact antineoplaston-induced necrosis can be indistinguishable from radionecrosis

[L] – Analysis by Buckner et al could’ve highlighted 2 patients with recurrent glioblastoma who survived for more than 1 year

This is of interest because patients typically have life expectancy of 3 to 6 months

[M] – At time of the study by Buckner et al, the sponsor, NCI, decided against higher dosing regimen I proposed and closed the study

Study used dosing regimen known to be ineffective
======================================
[4] – 10/4/1991 – Five doctors (3 from the Cancer Therapy Evaluation Branch (CTEP); including the Head of the Quality Assurance and Compliance Section, Regulatory Affairs Branch, Cancer Therapy Evaluation Program, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, and 2 invited consultants; including one from the National Institutes of Health (NIH) Clinical Center) visited the offices of Dr. Stanislaw R. Burzynski
——————————————————————
[5] – 10/31/1991 – Michael A. Friedman, M.D. Associate Director, Cancer Therapy Evaluation Program (CTEP), Department of Health &Human Services, National Institutes of Health, National Cancer Institute, sent a one page Memorandum to Bruce A. Chabner, M.D., Director, Division of Cancer Treatment, which stated, in part:

“I thought you would be interested in this for several reasons:”

“3. Antineoplastons deserve a closer look”

“It turns out that the agents are well defined, pure chemical entities
=======================================
=======================================
“The human brain tumor responses are real”

20130911-102213.jpg
=======================================
[6] – 11/15/1991 – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, sent a 7 page letter to Decision Network, which stated, in part, on page one:
=======================================
=======================================
“It was the opinion of the site visit team that antitumor activity was documented in this best case series … “

20130911-122216.jpg
=======================================
[7] – 12/2/91 – NCI (National Cancer Institute), Decision Network Report on Antineoplastons, states in part, on page 11:
=======================================
=======================================
“The site visit team determined that antitumor activity was documented in this best case series … “

20130911-134634.jpg
=======================================
[8] – CANCER FACTS
National Cancer Institute • National Institutes of Health Department of Health and Human Services, Antineoplastons, pg. 1

=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “

20130911-094155.jpg
=======================================
[9] – Page 1 of 6, BlueCross BlueShield of Alabama, Antineoplaston Cancer Therapy, Policy #: 280, Category: Medicine, states, in part, on page 2 of 6:

Key Points:
=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “
=======================================
=======================================
[10] – ANTINEOPLASTON THERAPY, HS-183, pg. 2
=======================================
=======================================
“After the reviewers found some evidence of antitumor activity … “
=======================================
=======================================
These facts indicate to me that Wikipedia’s claim about “antineoplastons”, is “debatable”

Maybe they should have learned how to use the Freedom of Information Act (FOIA)
=======================================
REFERENCES:
=======================================
[1]
——————————————————————
http://en.wikipedia.org/wiki/Burzynski_Clinic
——————————————————————
http://en.m.wikipedia.org/wiki/Burzynski_Clinic
——————————————————————
Antineoplastons, Memorial Sloan-Kettering Cancer Center
======================================
[2] – 2/1999 – A10 and AS2-1 – Phase II
Mayo Clinic Proceedings
http://www.ncbi.nlm.nih.gov/m/pubmed/10069350
Phase II Study of Antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in Patients With Recurrent Glioma

Material & Methods:

Patients received escalating doses of A10 and AS2-1 by multiple intermittent intravenous injections with use of portable programmable pump to the target daily dose of 1.0 g/kg for A10 and of 0.4 g/kg for AS2-1

Mean steady-state plasma concentrations of phenylacetate & phenylacetylglutamine after escalation to the target doses of A10 and AS2-1 were 177 +/-101 ug/mL & 302 +/- 102 ug/mL, respectively

Results:

9 patients were treated, in 6 of whom treatment response was assessable in accordance with protocol stipulations
http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)63835-4
Comment in Jun; 74 (6): 641-2
http://www.sciencedirect.com/science/article/pii/S0025619611638354
Mayo Clin Proc 74(2):9 (1999), PMID .10069350
http://www.mayoclinicproceedings.org/article/S0025-6196(11)63835-4/fulltext
DOI: 10.4065/74.2.137
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS0025619611638354.pdf
Mayo Clin Proc 1999; 74: 137–145
http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.2003.01098.x/full
Mayo Clin Proc 1999; 74: 137–45
http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.2003.01098.x/references
J C Buckner, M G Malkin, E Reed, T L Cascino, J M Reid, M M Ames, W P Tong, S Lim, W D Figg
http://onlinelibrary.wiley.com/store/10.1046/j.1365-2796.2003.01098.x/asset/j.1365-2796.2003.01098.x.pdf?v=1&t=hbs6xce2&s=3423e3cd1955667e8e8cdf33323faf0bd85b6a29
Department of Oncology, Mayo Clinic Rochester, Minnesota USA
http://onlinelibrary.wiley.com/store/10.1046/j.1365-2796.2003.01098.x/asset/j.1365-2796.2003.01098.x.pdf?v=1&t=hbrndkdf&s=e0af2d3bfb13841852d92a839d3a4932a5f4bb48
======================================
[3] – 6/1999 – A10 and AS2-1
http://www.ncbi.nlm.nih.gov/pubmed/10377942
Efficacy of antineoplastons A10 and AS2-1
http://www.ncbi.nlm.nih.gov/m/pubmed/10377942
S R Burzynski
Mayo Clin Proc 74 (6): 641-2 (1999),
Mayo Clin Proc. 1999 Jun; 74 (6): 641-2
http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)64143-8
Comment on
Mayo Clin Proc. 1999 Feb; 74 (2): 137-45 PMID .10377942
http://www.mayoclinicproceedings.org/article/S0025-6196(11)64143-8/fulltext
Mayo Clin Proc. 1999
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS0025619611641438.pdf
Comment on
Mayo Clinic Proc. 1999; 74: 641–642 (letter)
http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)64143-8
Mayo Clin Proc
74 (6): 641-2
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS0025619611641438.pdf
Mayo Clin Proc 74 (6): 1 (1999),
Elsevier Ltd.
DOI: 10.4065/74.6.641
1999 – A10 and AS2-1 – Mayo
Buckner, Reid, & Malkin
Mayo Clin Proc 74 (6): 2 (1999),
Elsevier Ltd.
DOI: 10.4065/74.6.641-a
http://www.mayoclinicproceedings.org/article/S0025-6196(11)64144-X/fulltext
Mayo Clinic Proceedings
74(6):2 1999 Elsevier Ltd.
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS002561961164144X.pdf
=======================================
[8]
——————————————————————
http://www.emory.edu/KomenEd/PDF/Treatment/Antineoplastons.pdf
=======================================
[9]
——————————————————————
https://www.bcbsal.org/providers/policies/final/280.pdf
=======================================
[10]
——————————————————————
https://www.wellcare.com/WCAssets/corporate/assets/HS183_Antineoplaston_Therapy.pdf
=======================================

Critiquing: Memorial Sloan-Kettering Cancer Center (MSKCC)

[1]Memorial Sloan-Kettering Cancer Center (MSKCC), How It Works,, claims:

”Bottom Line: There is no clear evidence to support the anticancer effects of antineoplastons in humans”
——————————————————————
Interestingly, the above “Bottom Line” does NOT provide any specific citation(s), reference(s), or link(s) to support this claim
——————————————————————
[2] – 10/4/1991 – Five doctors (3 from the Cancer Therapy Evaluation Branch (CTEP); including the Head of the Quality Assurance and Compliance Section, Regulatory Affairs Branch, Cancer Therapy Evaluation Program, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, and 2 invited consultants; including one from the National Institutes of Health (NIH) Clinical Center) visited the offices of Dr. Stanislaw R. Burzynski
——————————————————————
[3] – 10/31/1991 – Michael A. Friedman, M.D. Associate Director, Cancer Therapy Evaluation Program (CTEP), Department of Health &Human Services, National Institutes of Health, National Cancer Institute, sent a one page Memorandum to Bruce A. Chabner, M.D., Director, Division of Cancer Treatment, which stated, in part:

“I thought you would be interested in this for several reasons:”

“3. Antineoplastons deserve a closer look”

“It turns out that the agents are well defined, pure chemical entities
=======================================
=======================================
“The human brain tumor responses are real”

20130911-102213.jpg
=======================================
[4] – 11/15/1991 – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, sent a 7 page letter to Decision Network, which stated, in part, on page one:
=======================================
=======================================
“It was the opinion of the site visit team that antitumor activity was documented in this best case series … “

20130911-122216.jpg
=======================================
[5] – 12/2/91 – NCI (National Cancer Institute), Decision Network Report on Antineoplastons, states in part, on page 11:
=======================================
=======================================
“The site visit team determined that antitumor activity was documented in this best case series … “

20130911-134634.jpg
=======================================
[6] – CANCER FACTS
National Cancer Institute • National Institutes of Health Department of Health and Human Services, Antineoplastons, pg. 1

=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “

20130911-094155.jpg
=======================================
[7] – Page 1 of 6, BlueCross BlueShield of Alabama, Antineoplaston Cancer Therapy, Policy #: 280, Category: Medicine, states, in part, on page 2 of 6:

Key Points:
=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “
=======================================
=======================================
[8] – ANTINEOPLASTON THERAPY, HS-183, pg. 2
=======================================
=======================================
“After the reviewers found some evidence of antitumor activity … “
=======================================
=======================================
These facts indicate to me that Memorial Sloan-Kettering Cancer Center’s (MSKCC) claim about “antineoplastons”, is “debatable”

Maybe they should have learned how to use the Freedom of Information Act (FOIA)
=======================================
REFERENCES:
=======================================
[1]
——————————————————————
http://www.mskcc.org/cancer-care/herb/antineoplaston
=======================================
[6]
——————————————————————
http://www.emory.edu/KomenEd/PDF/Treatment/Antineoplastons.pdf
=======================================
[7]
——————————————————————
https://www.bcbsal.org/providers/policies/final/280.pdf
=======================================
[8]
——————————————————————
https://www.wellcare.com/WCAssets/corporate/assets/HS183_Antineoplaston_Therapy.pdf
=======================================