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

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

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

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

Uhhh

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

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

(Freudian sarcasm slip)

I decided to take the position of being a Skeptic Skeptic

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

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

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

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

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

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

Uhmmm, and that’s gone nowhere

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

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

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

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

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

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

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

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

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

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

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

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

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

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

And they had 2, 2 patients that were dealt with

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

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And I think that was maybe the case with Luna, I think she was only there for a month

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

I’m sure that they’re tired of that

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

Uhhh [21]
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He’s read everything

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

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

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

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

Could you send me that link, to that publication

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

Uhm

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

So, just think

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(Clarification: 1997)

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

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

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

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

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

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

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

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

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

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

This is really important though

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Uhmmm, hi everyone

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

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

What was their experience, you know ?

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

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

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

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

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

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

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

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

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

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

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

(Clarification: 7)

And see the same MRI’s and scans, etcetera

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

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

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

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

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

Let me

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

That turns his claims into something that’s unfalsifiable

If I could give you an example of what unfalsifiable is

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

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

Well, I don’t see anything

Well it’s an invisible dragon

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

Well, it’s incorporeal

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

Well it’s heatless flame that it breathes

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

And, oh no it’s ah it’s floating

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

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

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

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

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

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

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

So what’s the hold-up ?

I mean, hopefully they’ve done an autopsy

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

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

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

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

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

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

Um

Hold on a sec

She is a cute kid though

Um, alright

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

They were delighted

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

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

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

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

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

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

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

Um, and that was a

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

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

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

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

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

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

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

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

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

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

Well, okay

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

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

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

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

That’s pretty basic

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

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

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

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

You’re you’re you’re assuming that

You’re assuming that

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

Um, this, what would, what would convince you that you’re wrong
——————————————————————
The FDA not giving him phase 3 approval [12], the FDA not giving him ODD designation [10]
——————————————————————
So you’re saying because the Orphan Drug Designation and the face that there’s a phase 3, therefor it works ?
——————————————————————
And showing that, and showing the FDA that there’s evidence of effectiveness [11]
——————————————————————
So what you’re saying is there’s nothing that would convince you now, that it doesn’t work
——————————————————————
Not until the FDA says it doesn’t work
——————————————————————
O-kay

Um, it’s it’s it’s not the FDA’s, but you understand it’s not the FDA’s job to tell someone that their drug doesn’t work
——————————————————————
Well they seem to be doing a good job of it
——————————————————————
1:03:00
——————————————————————
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
——————————————————————
Well I’m sure, I’m sure they wouldn’t have done things if they didn’t see some evidence that it was working
——————————————————————
Um, I don’t know if you’ve read Jaffe’s book
——————————————————————
No I haven’t read it [44]
——————————————————————
There seems to have been a lot going on there you really should look at it because it’s it’s it’s kind of revealing

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

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

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

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

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

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

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

So the FDA is protecting him, uh from outside scrutiny

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

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

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

Um, definitely look at that

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

That comes across very clearly

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

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

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

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

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

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

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

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

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

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

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

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

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

Now, someone has just sent a a note, uh that he has failed 3 different Institutional Review Board audits; this is Guy Chapman (@SceptiGuy), uh no other institution has a 3 for 3 fail, according to to Guy iye he knows no other one

Um, that 45% of phase 3 clinical trials fail due to deficient phase 2 design

Um, he has an approved phase 3, but phase 2 was deficient so phase 3 fails
——————————————————————
1:09:07
——————————————————————
Do you think that that could possibly have anything to do with why we’re not seeing the phase 3 advance
——————————————————————
Well #1 I don’t think the one with brainstem glioma where they wanted to use radiation with ANP was really the right way to go, I mean he’s already proven that uh he seems to have better results without [12]
——————————————————————
He’s claimed
——————————————————————
first starting radiation [20]
——————————————————————
He’s claimed

That’s a different thing altogether

And in fact
——————————————————————
Yeah but the thing is radi, I, the FDA was not saying, ok, one study, one side of the study we’re only going to use ANP, in the other side of the study we’re going to use radiation and and ANP like like they would normally do

No, they wanted to make him use radiation in both sides of the study [20]
——————————————————————
Well, you understand why they do that, because in order to, it’s
——————————————————————
They don’t do that with other drugs [13]
——————————————————————
No, they do do this with other drugs, well, it depends on the type
——————————————————————
1:10:01
——————————————————————
Some drugs it’s ethical to give something completely questionable, what they want to make sure that they at least get the standard care, you know which includes radiation

Um, and radiation does seem to extend life, reduce the size of some tumors some times

Um, do you concede, that in order to have a phase 3, you do not need to have a successful phase 2 ?

When 45% of phase 3 fail because they have a deficient phase 2 design, do you concede that ?
——————————————————————
Well I don’t buy anything Guy Chapman sells, considering his past record [46]
——————————————————————
Well, ok

It doesn’t matter where
——————————————————————
(laughing)
——————————————————————
It doesn’t matter where it comes from uh, um
——————————————————————
Well his theories are suspect, anything he hands out, let me tell ya [47]
——————————————————————
So-kay, um that would be shooting the messenger as opposed to dealing with the question, but
——————————————————————
But the question may be bogus, because of where the messenger has been bogus a lot of times before (laugh) [48]
——————————————————————
1:11:04
——————————————————————
the idea, the best, well, the best, well in that case the best response is “I don’t know”
——————————————————————
Well I’m just gonna say what I think about Chapman because he’s proven himself, many times to be questionable

I don’t see him on my blog responding to my criticism [7]
——————————————————————
There’s something that that we don’t know, you’re coming, honestly we didn’t know what to expect when we talked to you

We, were looking at the design, of your web-site and wondering whether or not we would be able to get a a coherent sentence out of you, because the web-site is disorganized, uh

Um, at at at at least it’s the organization is not apparent to the readers

Um, and um according to
——————————————————————
That’s like, that’s like saying that Gorski’s web-site is disorganized, his blog is like anti vaccine one day, Burzynski the next, blah blah blah
——————————————————————
No, that is tied together
——————————————————————
1:12:00
——————————————————————
(laughing)
——————————————————————
But let me, we know that that the the, the central concern is Burzynski

Ah, the source of this ah of of those #’s that I just gave you, Chapman has just updated me and he says um that it is, and I’ll go back to the, the ADR research . com issues in clinical research, so it’s the question, Bay Clinical uh Research and Clinical Development,a white paper called “Why do so many phase 3 clinical trials fail ?”

Uh, it’s prepared by Anistazios Retzios, Ph.D

Is Anistazios Retzios reliable ?

There is a correct here
——————————————————————
Well how would I know ?

I don’t have
——————————————————————
Exactly

That’s the right answer

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
——————————————————————
1:13:00
——————————————————————
Everytime somebody throws uh uh something to me, I have to look into it

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

Um
——————————————————————
Well you didn’t when I tried to get you to do stuff the 1st time, did ya ? [2]
——————————————————————
What, what stuff would you like
——————————————————————
(laughing)
——————————————————————
What stuff would you like me to do ?

I generally, I don’t read your blog
——————————————————————
Well I, the most, the mostly, excuse me, the most recent article I posted on there is the one about this particular conversation, where I went through all your comments that you had posted, and my response to them

And so I tried to consolidate everything into one, particular article
——————————————————————
Uh um, alright
——————————————————————
And that’s the newest article [2]
——————————————————————
Okay, I’ll look at that, and I will respond to it once I’ve taken a look at that, okay ?

Um, and I’ll respond on your web-site

Um, seems only fair

Um, one question I’d wondered, what is the Didymus Judas Thomas reference to
——————————————————————
1:14:00
——————————————————————
Well I thought that was pretty funny because doing biblical research, you come upon, Didymus Judas Thomas, or he’s all, also known by other names

He’s basically The Skeptic

And so, like I said, I consider myself to be Skeptic of The Skeptics
——————————————————————
Oh, so this is the Doubting Thomas
——————————————————————
I thought it was apropos

Of course
——————————————————————
This is the Doubting Thomas
——————————————————————
I’m doubting The Skeptics

Exactly
——————————————————————
Okay, so this is the one, you show me the, you put your your, the, your hand inside the wound

You know, Jesus says, basically, ok, bring it on, check me out, right ?
——————————————————————
Exactly
——————————————————————
Okay

Alright

That that, I didn’t, I didn’t realize that he was also, that that was the same guy

So, it’s it’s the Doubting Thomas

Um, what we would say, um, is that if Burzynski is the savior that he claims to be, that he should, open up his trials, he should open up his uh research uh protocols um and just say, “Look, bring it on”
——————————————————————
1:15:08
——————————————————————
Check out these wounds

But he’s never done that

Instead he he he wants us to just take the words of of of of his apostles

I don’t necessarily trust his apostles

I don’t think that they’re unbiased

(laughing)

I wanna see the data

I wanna see the the wounds in his hands and the the mark on his side
——————————————————————
Well I like how The Skeptics say, you know, all of Burzynski’s successes over the years are anecdotal and uh I consider on the same way that everything negative about Burzynski is anecdotal
——————————————————————
Oh, hey when when we talk about The Other Burzynski Patient Group, I don’t make any pretensions to make that my site proves anything

I I I really don’t

It’s not my job to prove anything

It’s Burzynski’s job

It is a researchers job to prove these things
——————————————————————
1:16:00
——————————————————————
Well my point is he’s proven them to the FDA because they’re the ones
——————————————————————
But we just pointed out, we just pointed out, that the FDA, often approves, phase 3 trials, based on flawed phase 2 clinical trials

That is therefor a real possibility in this case
——————————————————————
Could be, but I would have to read, read the
——————————————————————
Yes you would

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

But, um, uh but the way that you’d earlier phrased your uh your response to “could you possibly be proved wrong ?”, . . really did exclude other possibilities of of of of yourself being wrong

So if the FDA
——————————————————————
Well when it comes to Guy Chapman, yeah
——————————————————————
Well I’m not talking about the Guy Chapman

What you off, when I asked you, yourself, you know, what would prove you wrong, you said that the FDA hasn’t approved a phase 3
——————————————————————
1:17:03
——————————————————————
Well, ok

Let’s let’s back, let’s back up

What would the FDA, what happens if the FDA occasionally op op opposes, approves uh phase 3 trials, based on bad phase 2 trials

Would that be, would that cause any doubt in your mind ?

About the efficacy of ANP
——————————————————————
You still there ?
——————————————————————
Yeah, hello, yeah, you’re back
——————————————————————
Yeah, something cut off there for awhile
——————————————————————
Yeah Google+ is a little wonky sometimes

But, would, does, if you were to learn, that sometimes phase 3 trials, uh, are approved, and failed, based on flawed phase 2, would, would that make you reconsider your position of the phase 3 being evidence that it works
——————————————————————
1:18:00
——————————————————————
Well I would certainly look at that, but then again I would also look at the FDA granting him Orphan Drug Designation [10]
——————————————————————
Uh um could you send me that link, the, the, um . me see

I’m just looking at other things that are coming in on the Hashtag right now

Um, so the ANP is Orphan Drug status but is it Orphan Drug for glioma ?
——————————————————————
Orphan Drug for brainstem glioma and all gliomas [10]
——————————————————————
Is it sodium phenylbutyrate or is it the the versions of the drug, the AS10 stuff or A1 or whatever it’s called ?
——————————————————————
Right, it’s both AS10 AS2-1 and AS
——————————————————————
Clarification: A10 and AS2-1
——————————————————————
Okay, that’s what has Orphan Drug status

Alright, I’ll look into that

I hope somebody is writing all this down out there, so that we can go back and look at these claims later, right ?
——————————————————————
1:19:00
——————————————————————
So, oh, um

Do you have any questions for me ?

I’ve spent a lot of times asking questions of you
——————————————————————
Well not really, since you mentioned that you’d go in and look at my most recent article, anything you show in there or any reply you give is going to cover, what we’ve gone over

And so we can re debate it there
——————————————————————
Mhmm

Guy Chapman, throws up the the, the comment, permission to investigate is not evidence of anything other than evidence of a valid protocol, not a uh, evidence of efficacy, in and of itself

That’s another comment

Um, alright then, this is your chance t, there are lots of people have lots of questions about me out there

Uh, about what my motivations are and such

I might as well put that out on the table just so it’s on the record, is that I am taking exactly no money from anyone for this, and have gotten nothin’ but grief from a lot of people, even people who (laugh), even people who support me have given me grief for this

Um, just so that you know, um, there have been, some of the things that have happened, oh, this is an important point too

Um, that when we have criticized this, uh, a # of us, especially Gorski, uh myself, uh Rhys Morgan, uh, um, and and uh Popehat, the the lawyer, blog, uh, um, who else was on there, um, oh, the Merritts, uh, t, uh Wayne Merritt, and his family, people have been critical of of of Burzynski have faced retaliation for opposing him ah and intimidation, and including, um, I had my uh a couple weeks before Christmas my, my, the Chancellor of my University was contacted via e-mail, and uh Eric Merola said that I had been um, uh, been spreading mis truths about Burzynski, that I had been a be, on my my show um had said things that were demonstratively untrue, and he also said that the drug was FDA approved, which it, you know, that’s not right

But um, he said that he was gonna do, talk about me in his new movie, in, uh, relat, in millions of homes, um, and he wanted to get a statement from the University
——————————————————————
1:22:02
——————————————————————
The University of course ignored him, and immediately let me know that I was going to get smeared

Um, I consulted my lawyer and uh uh, you know, the best course of action was figured out, and um uh a Gorski has had his accreditation board contacted, he’s had his bosses contacted, Rhys Morgan received threats of liable suits from somebody who had been hired, by the clinic, to clean up his on-line reputation if he didn’t take down his on-line review of Burzynski, uh, had his a picture of his house sent to him, clearly the message being, “We know where you live kid,” uh, Wayne Merritt; a pancreatic cancer patient, this is something that, that people generally, do not recover from, like generally, die from, received phone calls at home, from, this individual, threatening him with lawsuits; he doesn’t have a law degree so he’s misrepresenting himself
——————————————————————
1:23:15
——————————————————————
Um, but all of this, was done, to critics

Do you think that is deserved ?

Do you think that that is right ?
——————————————————————
Well I’ve specifically stated on my blog that Marc Stephens uh obviously didn’t know what he was doing and went about it the wrong way

My position was he should of bou, got around it, gone about it the way I did, which is, I blog, and show where Rhys is wrong [49], I blog and show where Gorski is wrong [40], I blog and show where you are wrong [2], or Josephine Jones [50], or Guy Chapman [7], etcetera

And, eh, y’all have every opportunity to come on my blog, and I’ve had very few takers, uh, one claiming to be from Wikipedia, who I shot down [51]
——————————————————————
1:24:04
——————————————————————
And hasn’t come back

So, you know, I am welcome to anybody trying to come on my blog, and prove what I posted is wrong, and debate anything

Unlike some of The Skeptics I don’t block people on my blog
——————————————————————
Mhmm
——————————————————————
I don’t give lame reasons for blocking people on my blog because I’m an American and I actually believe in “Free Speech”
——————————————————————
Well to be fair

It it it doesn’t strike me as necessarily a “Free Speech” issue, you know
——————————————————————
Well to me it is when Forbes removes all my comments, in response to Skeptics some, and I showed this from screen-shots

You know, stuff like that [52]
——————————————————————
Was it down-voted ?
——————————————————————
Oh no
——————————————————————
No
——————————————————————
It wasn’t down-voted
——————————————————————
Mhmm
——————————————————————
They, I mean I’ve got screen-shots of where my comments were there, between other people’s comments, and uh, and they just decided to remove all my comments, and I blogged specifically about, you know, what they did and, uh, Gorski’s good friend and pal who authored that particular article
——————————————————————
Mhmm
——————————————————————
So I, I like how The Skeptics run things, you know
——————————————————————
1:25:14
——————————————————————
Well we do have for for for for one thing, um, I guess to understand is that we are uh motivated by um uh a respect, this is the one thing that that all Skeptics I think um are uh respect critical thinking, um, and um respect scientific uh a we we’re mostly scientific enthusiasts, there’s some Skeptics who are not um, uh, you know oh u space nerds, or whatever who are um just sc scholars and the humanities but for the most part we all respect scientific consensus and we respect scientific method and have an enthusiasm for living in the real world, this is something that like all of us us are about
——————————————————————
1:26:00
——————————————————————
And to that end, sometimes that influence is how we run, is how we decide to run our personal web-sites

Um, uh, that whether or not we want our, to give a platform to people who disagree with us, um, you know, uh, when we do, uh . . it it is our sandbox, you know, right ?

This, this (laughter), we’re allowed to to let whoever we want into our sandbox if we, you know, uh if we want
——————————————————————
Well I think that people who really believe in “Free Speech,” and when it’s done rationally, I mean, Gorski would never, really respond to any of my questions, so I [53]
——————————————————————
Did he, did he leave them up ?

Did he leave them up ?
——————————————————————
Well I know that he specifically removed a review I did uh of his review of Burzynski I on his web, on his blog

But he’s pretty much left a lot of my comments up that I’ve seen

Uh, but he never really responded to my questions about, what he based his beliefs upon
——————————————————————
1:27:00
——————————————————————
Right, um, do you think that he is required to answer you
——————————————————————
Well I would think, if you’re going to base your position on a certain thing, and then you can’t back it up with scientific literature, uh, you should answer, maybe not specifically to me, but answer the question

Answer to your readers
——————————————————————
Right
——————————————————————
You know, I can tell his readers come on my blog because it shows that they come on my blog
——————————————————————
Mhmm

Um so a a question uh why were why do you have so many Twitter and Wikipedia sock-puppets
——————————————————————
Well the reason I have so many Twitter things is because, obviously, some of The Skeptics will be on there lying about some tweet I sent, and so Wikipedia, excuse me Twitter will do a little ol’, do their little, hey we’re going to block your account while we do blah blah blah, and I’m not gonna waste my time, going through their little review process, I’ll just create another uh Twitter address because, like, you know, if you read the Twitter information you can have a ridiculous amount of uh Twitter I.D.’s, and I’ll just use another Twitter I.D. and continue on
——————————————————————
1:28:15
——————————————————————
And so Wikipedia can say what they want, because I’ve only ever used one I.P., I’ve only got on there during one time, and when they finally said hey, you know, we’re not gonna uh grant your appeal, I completely left their web-site alone, so all that stuff [54]
——————————————————————
Wikipedia

You left Wikipedia
——————————————————————
that they post [55]

Yep [56]

So all that garbage that they posted about me, about how I supposedly got on-line, on these other articles is just entirely B.S. [57]
——————————————————————
Mhmm

Um a
——————————————————————
And if they can prove otherwise, I’d sure like to see it [58]
——————————————————————
Uh We have uh a response from David James, everyone uh gave you a fair shout

You were a spammer plain and simple

You couldn’t, you couldn’t

work out your questions
——————————————————————
But that’s what y’all always say

That’s what y’all like to say, about everything
——————————————————————
Twitter does not

Twitter does not block people for for arguing

Only for spamming and policy violations
——————————————————————
1:29:05
——————————————————————
Yeah I’m sure that’s what they like to say

I mean, you can report an e-mail, or report a twit, and they’ll block it

But um they’ll never come back and say, and this is why we blocked you, for this particular twit, for this particular reason
——————————————————————
Mhmm

Okay

Um, let me see

Each new account was blocked for additional violations of policies

Um, this is a uh uh referring to the Wikipedia rules too

Um, so
——————————————————————
Wikipedia is a joke [59]
——————————————————————
Um, Wikipedia, do you know why um they’ve locked the Burzynski page ?
——————————————————————
Oh sure, I’m sure, that’s no problem [60]

I don’t have any problem with them locking that [61]

You know, I could tell when I was on there, and when Merola was on there, because he had a different I.P. address than me, I could tell they were his questions because of the way they were formed [62]
——————————————————————
1:30:04
——————————————————————
So I said, well they’re not answering his questions, I’ll just take on that role, and uh ask his questions and ask further questions, and they didn’t wanna deal with it, you know [63]
——————————————————————
Did you notice the part where he threatened, did you notice the part where he threatened to expose Wikipedia
——————————————————————
Expose them for what ?

For doing what they do, which is basically provide false information and one-sided information ? [64]
——————————————————————
We have to, well, they they uh are looking that it’s not one-sided information they want to show

Like they discuss, there is controversy about this guy
——————————————————————
Oh, please

They get on there and they say hey, Lola Quinlan filed a lawsuit, but they don’t tell you anything else

They don’t tell you, you know, Jaffe’s side of the story, and her lawyer’s side of the story
——————————————————————
Yeah, Jaffe’s on there
——————————————————————
(laughing)
——————————————————————
Jaffe’s on there
——————————————————————
Oh Jaffe’s on there but on that specific article about Lola, they didn’t say, here’s the article that was posted on uh Lola’s attorney’s web-site that, that mentions both his responses and Jaffe’s responses, to the uh lawsuit
——————————————————————
1:31:10
——————————————————————
uh well you could add that if you hadn’t gotten blocked
——————————————————————
Uh, trust me, I tried to add that and they wouldn’t add it
——————————————————————
1:32:20
Okay

Um, so, who are you
——————————————————————
(laughter)

You know, The Skeptics like to be nasty, and so, I’ve been like Josephine Jones (@_JosephineJones)

If she wants to play anonymous, I’ll play anonymous [65]
——————————————————————
She’s gotten threats
——————————————————————
Well, I don’t threaten people

I don’t threaten Gorski

I don’t send letters to people’s employers

I deal with them directly, and, you know, if if they won’t answer questions, then, you know, I’ll just post them on my blog for other people to see, and question uh themselves
——————————————————————
So we don’t know who you are
——————————————————————
1:33:01
——————————————————————
Like I said, I’m going to be like Josephine Jones [66]
——————————————————————
Like, she has suffered at the hands of some really mess, and she’s also, you have to realize she’s in the U.K, where libel laws are very lax at this point

That’s changing, ah, but uh, the the legitimate criticism, there is a big case last, me maybe 2 years ago of Simon Singh, talking about an alternative therapy, and, um, he was just saying that there’s no evidence for it but it’s promoted by um chiropractors, or something, or something like that

And he got slapped with a libel suit that cost him several years of his life and a lot of money

Um, so, there are several reasons why someone in the U.K. might uh be uh reticent to use their real name um, uh, and legitimate reasons

Um, in the U.S., I’m not sure that there is
——————————————————————
1:34:00
——————————————————————
I’ve been using my real name for a long time now

Um, you know, Gorski blogs under his real name, and is critical of uh, uh, also, let’s face it, everyone know, knows who “Orac” is

Um, how do we know that you don’t work for the clinic ?
——————————————————————
Because I’ve said so

I’m not even in Texas

I was born in Texas, but I don’t live in Texas

I don’t even, didn’t even, uh live in Houston
——————————————————————
Mhm
——————————————————————
Wasn’t even close to Houston
——————————————————————
Well see, one of the the problems is, Ju, I don’t know if you were around for the BurzynskiSaves thing

Did you ever see that account ?
——————————————————————
Oh, of course, I, I’ve seen a lot of stuff goes on Twitter [67]

I’ve see y’all saying “Oh, we’re “The Skeptics” and y’all know are names,” but, there’s a lot of Skeptics that post on there with pseudonyms, also [68]
——————————————————————
Mhmm

Right

Oh no, I mean you have a right to do that but but I I’ve found that posting under a pseudonym diminishes my credibility

Um, so, . . the quote was uh um, uh, “Happily promotes bogus therapies,” was Simon Singh’s quote that got him sued
——————————————————————
1:35:10
——————————————————————
Um, but Josephine Jones does it to, quote “protect her family”

Um

So there’s that

Um, are you afraid for you’re family ?
——————————————————————
Well, I’m just not sure how some of these uh Skeptics will react considering their past behavior [69]

I mean, when Skeptics refuse to, I mean they block you on your blogs [70]

They block your comments [71]

You know, they decide, “Well, I’m maybe going to accept one comment from you, but I won’t accept anymore [72]

You know, to me that’s just ridiculous [73]

Uh, the action on Forbes that happened, the action on The Guardian that happened, where, you know, you had someone on Gorski’s blog basically lie to the Gua, to The Guardian to get them to get them to uh block my comment [74]

So, you know, I’m Skeptical of The Skeptics and their uh and what they would do [75]
——————————————————————
1:36:01
——————————————————————
Um, you don’t see that there would be anything to gain from, from going on-record ?
——————————————————————
Not really [76]

I like my anonymity just like Josephine Jones likes hers [77]

I mean, I will read her stuff and reply to it and treat it seriously jus, just like any other blogger [78]
——————————————————————
Um I I haven’t, I’ve never, honestly, I’ve never seen a Skeptic actually go after a person individually

Um, you know, uh, you, unless they were doing colossal harm to people

Um, to to focus on an, uh, let’s say, call someone’s work for um, yeah

Cite one example, of a Skeptic making shit for a Burzynski shill or anyone else in real life

That’s a quote

That’s, that’s something coming in from, from Guy
——————————————————————
1:36:00
——————————————————————
Well the thing is, some of these Skeptics use names, and they’re not necessarily their real names

So, you know, I’ve seen
——————————————————————
Like had anyone ever contacted Sheila Herron, or has anyone to to um, go after her job, or go after um, you know, my brother has gotten stuff from people

He didn’t tell me because he didn’t want to upset me, but my brother gets things from Burzynski supporters that are violent and threatening

I get letters telling me that I suck cancer’s dick

Um, I I’ve all sorts of things um, and I just, I’ve never seen that, that intrusion into real life on the part of uh, um, uh, Skeptics

I’ve never seen them doing that type of of of stuff

I’ve never seen them threatening bogus lawsuits

Um, and I I I wonder there, if there is some sort of, what do you think accounts for that, that difference?
——————————————————————
Well I think that some people just have bad manners
——————————————————————
Mhmm
——————————————————————
I mean see, I’ve seen Skeptics on Twitter basically harass someone pro-Burzynski and keep sending them tweets, and that person specifically send them a tweet saying please keep, stop sending me tweets

You know, they didn’t go in and ask Twitter to block the, that particular person

That person just kept sending them tweets
——————————————————————
Mhmm
——————————————————————
So, you know, I’ve seen that stuff before
——————————————————————
I’ve I’ve I’ve shown up on, you know, as you, as you might, I imagine you moni, you monitor the Hashtag, right ?
——————————————————————
Yeah, I’ll look at it, and if you notice, I don’t uh, I usually don’t reply to Skeptics individually because I pretty much figure that y’all are gonna try and get my next account blocked whenever I do that kind of junk, so, well, you know, I just post what I want to post, under the Hashtag
——————————————————————
1:38:01
——————————————————————
Okay

Um, which is, which is your right

Um, uh, but every so often I jump in and say, you know, this movie has some flaws in it

You know, that’s something I say rather frequently

Um, and I invite people, if they’re interested, to take a look at a couple of links

I don’t, I, you’ll notice that I no longer force people to like, “Well how do you explain this ?,” because that doesn’t seem to be very persuasive, or work at all

Ah, only people who are open minded to having their mind changed, those are the only ones I want to talk to

So I give them a choice

Kind of like Morpheus in The Matrix really

Um, b, that was a joke for me

Um (laugh), um anyway

Um, but, it it I, honestly, I would encourage you to go on-record, um, but I have, less than nothing invested in that, so, um
——————————————————————
(Why would I want to reveal my identity, when David H. Gorski, M.D., Ph.D., FACS, a/k/a “Orac” claimed that he was pretty certain he knew who I was ?

Just Bring it, Gorski)

20131015-181243.jpg
——————————————————————
1:39:00
——————————————————————
Uh, what’s next for you
——————————————————————
Well I’ll just keep reviewing the, any inaccurate statements I see posted

You know, it depends on if it’s Gorski, you know

Gorski’s gone on there and posted inaccurate stuff, and I call him out, you know he’s basically said on his blog, you know, if I do something inaccurate, you know, I’ll ‘fess up to it

Well, I’ve pointed out where he’s done that and said “Hey, you said you were gonna ‘fess up to it”

If I said on my blog that I was going to ‘fess up to doing something wrong, and you caught me, well, then I should, come out and say, “Okay, you got me”

But Gorski won’t even do that, you know, he just continues to go on down the road, as if
——————————————————————
Well what happens

Well what happens if he doesn’t understand what you’re saying ?
——————————————————————
(laughing)
——————————————————————
I mean one of the
——————————————————————
excuse
——————————————————————
I mean seriously

Well, one of the problems I think that a lot of Skeptics have had, in in back channel discussions about this is that we don’t understand exactly what you’re saying
——————————————————————
1:40:01
——————————————————————
We certainly don’t understand why you’re so attached to him if you’ve never had any uh, you know, close dealing with uh, uh, with Burzynski

We don’t really understand that
——————————————————————
I find, I find
——————————————————————
Actually, especially when you consider, that all the information that we’ve put forward, that we’ve backed up with statements from uh, you know, uh, it, it, the statements that we have from from patients saying that you know, we’ve we’ve, we were told that, no that’s not exactly, they put it usually that but that that we believe that getting worse is getting better

Like how could someone continue to defend someone, when we pile up all of these different, you know, sources, saying the same thing ?

It it is, it is beyond us and we wonder if there’s absolutely anything that we could say that would convince you otherwise
——————————————————————
You know, I’m just going to let the FDA do their job, and let y’all speculate all y’all want

Uh, I mean (laugh)
——————————————————————
But, I mean, but that means
——————————————————————
1:41:00
——————————————————————
See, I’m here for full discussion

And y’all don’t seem to want to discuss, after y’all just go out there and spam the Internet with garbage, that you don’t back-up with citations and references and links
——————————————————————
Everything on The Other Other Burzynski Patient Group is referenced

It goes
——————————————————————
But some of your other stuff that you tweeted that you haven’t backed up with links, and some of the stuff on thehoustoncancerquack isn’t backed-up with links, and Gorski’s stuff
——————————————————————
There’s very little on
thehoustoncancerquack

There’s very little on
thehoustoncancerquack in the 1st place

——————————————————————
Well, that and the anp4all one

isn’t backed up
——————————————————————
Eh, right

The they both go to the same place

Uh un but, you know, we, the thing that that totally befuddles us, and is just endlessly frustrating, is like how many more examples, of patients believing that getting worse is getting better, and it’s not us saying it, it’s the patients saying it
——————————————————————
1:42:00
——————————————————————
And how many more of those patients do we need to to give you before you will like reconsider that perhaps you might be wrong ?
——————————————————————
When the FDA says he’s wrong

I mean, I’m not, I’m not just gonna accept your story
——————————————————————
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
——————————————————————
Burzynski provides the FDA with the evidence, and the FDA makes the
——————————————————————
The evidence would be
——————————————————————
the FDA doesn’t approve a drug
——————————————————————
The evidence
——————————————————————
if something’s not proved
——————————————————————
The evidence would be phase 2 trials

And ev the evidence would be a completed and published phase 3 trial

That’s not forthcoming

The phase 3
——————————————————————
Well you know that he’s trying

I mean, y’all can sit there and jump up and down all you want
——————————————————————
You don’t know that he’s trying

He’d start completing these trials

And he would, he would be soliciting um, uh, lots of um, uh, you know, you know he’d be putting out papers constantly um and if the the British Medical Journal example’s anything uh representative of how Burzynski works, he’d immediately tell everyone that his he’s being . . blackballed by the, by the journal, even when it’s just a courtesy that he gets a a rejection
——————————————————————
1:43:30
——————————————————————
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

So, given that what would, how many more patients do we have to show you before you consider that you may be wrong ?
——————————————————————
1:44:00
——————————————————————
Well, I’m gonna go with what the FDA is gonna do still because they’re running the show
——————————————————————
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

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
——————————————————————
What I find funny is that y’all complain, “Well, he hasn’t published, uh a final report”

Well his 1st final, was completed in 2009, and like I said, the M.D. Anderson 2006 study wasn’t published until 2, 2013

I mean, so y’all can jump up and down all you want

Y’all want a final report

Well, the final report will be done when the clinical trial is over
——————————————————————
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
——————————————————————
Well, unless you’re The Lancet, I guess
——————————————————————
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

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

It’s ultimately Burzynski

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 ?
——————————————————————
Well, I’m not gonna get into speculation, I’m just going to wait and see
——————————————————————
You’ve been speculating about what the FDA’s motivation are like crazy

Why not speculate about Burzynski a little bit
——————————————————————
Well, how have I been speculating ?
——————————————————————
1:46:00
——————————————————————
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 ?
——————————————————————
what the journals keep saying, in response
——————————————————————
What ?
——————————————————————
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

20130930-164002.jpg
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
——————————————————————
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
——————————————————————
Not that he’s been practicing medicine medicine for 36 years, or whatever, it’s when the clin, clinical trial was done
——————————————————————
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
——————————————————————
The FDA A believes there is evidence of efficacy
——————————————————————
Perhaps based on bad phase 2
——————————————————————
Well, we don’t know that

We don’t have the Freedom of Information Act information
——————————————————————
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
——————————————————————
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
——————————————————————
Uh did do do you think that if they thought that he was a real doctor that they all would have refused like that ?
——————————————————————
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
——————————————————————
He’s changed things
——————————————————————
Eric said they gave
——————————————————————
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
——————————————————————
We’ll I’m
——————————————————————
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
——————————————————————
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
——————————————————————
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
——————————————————————
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
——————————————————————
He should have access to this

We can’t get it

How how long will it take before you recognize that, nothing is forthcoming ?

How long would that take ?
——————————————————————
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
——————————————————————
Well, I mean, were talking about a blog here
——————————————————————
(laughing)
——————————————————————
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
——————————————————————
Nothing thas 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 ?
——————————————————————
Well, he gave you The Lancet information and he posted the e-mail in the movie, and Josephine Jones posted a copy of it
——————————————————————
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
——————————————————————
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
——————————————————————
Where has Eric been wrong ?
——————————————————————
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
——————————————————————
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
——————————————————————
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
——————————————————————
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
——————————————————————
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
——————————————————————
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
——————————————————————
Um
——————————————————————
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
——————————————————————
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
——————————————————————
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
——————————————————————
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
——————————————————————
Well, I’m sure, I’m sure Gorski would have a comment about that, as he’s commented previously about how he thinks uh Burzynski should publish
——————————————————————
Oh I, I I I certainly don’t think that he would put a lot of stock in it, but I, I, I know Dave Gorski enough, he wants this to work

He has patients who are dying, you know

And if if if let’s say that that Burzynski could get ah his gene-targeted therapy to work on breast cancer patients in in a reliable way, that would be, such a help to these people, that that Gorski’s trying to help
——————————————————————
1:57:10
——————————————————————
And, it it it doesn’t make sense, I mean, there, some of the best um, one of the the most important developments in medical history, was the development of of just washing your hands uh uh before uh uh going in and delivering a baby

Right ?

The guy who did it, was a colossal jerk, but it still worked and it’s the standard now

Right ?

Um, yea, it doesn’t matter now whether or not Burz, whether or not Gorski agrees with how Burzynski publishes

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
——————————————————————
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
——————————————————————
So then he can go on, you know, for however many years he wants to
——————————————————————
But he is a, the thing is, the thing is, you thing you have to understand is Gorski, Gorski is a genuine expert, in matters re re regarding on oncology studies

I mean, he has a
——————————————————————
Well,
——————————————————————
He, He’s able to convince people, he’s able to convince people, on the strength of his record, to give him money to carry out research

People who know what they’re talking about

To give him money to carry out his research

Right ?
——————————————————————
This is, this is a guy who must phone it in because, he went in there and posted the old Josephine Jones response that, you know, no drugs had been approved by the FDA without their final phase 2 publication 1st being published, which was not a factual statement, and you’ve made the same statement

So I, I’m thinking that Gorski just bought her statement and took it and ran with it, and before he fact-checked it, and what, what happened, it was wrong
——————————————————————
1:59:00
——————————————————————
I mean, Gorski needs to stop phoning stuff in, and check his sources before he posts stuff, because I’ve found many cases where, he hasn’t seemed to do that, and that’s why I question him
——————————————————————
Well what about all the other physicians, um, going back long before the Burzynski thing broke on-line

Of all these patients, with whom they have long-established relationships, and then doctors essentially after years, of treating these patients, basically saying, “I can’t work with you anymore if you go to Burzynski”

What about that ?

Di, are all of these doctors just as biased ?
——————————————————————
Well, I found it interesting that uh the one on the, Burzynski 2, you know he gave his ex excuses for not, working with uh, that patient, and, but yet, he was the same doctor that treated a another Burzynski patient, according to the movie
——————————————————————
2:00:00
——————————————————————
I mean, so what does he do ?

Pick and choose ?

Or do doctors pick and choose over there in Britain ?
——————————————————————
Did he get burned at some point ?
——————————————————————
Well, the movie didn’t say anything
——————————————————————
We don’t know

Yeah, well, you wouldn’t expect Eric Merola to say that he got, that a doctor got burned

Would you ?
——————————————————————
Well, I fail to see these doctors on there, providing any factual information, anywhere on the Internet about, uh their disagreements, in a serious way, instead of just making these over-broad statements, you know, “He hasn’t published anything in the blah blah blah,” and
——————————————————————
But he, he doesn’t have, he hasn’t given us his data
——————————————————————
Well, he’s provided some data, and specifically 4 publications
——————————————————————
He’s given, he’s given, he’s given case studies
——————————————————————
He’s given more than the case studies
——————————————————————
He’s done

Okay
——————————————————————
He’s done more than the case studies

He’s specifically given uh, almost all the information om an oncologist would want

And Gorski, and Gorski
——————————————————————
Except for a ph, completed phase 3 clinical trial
——————————————————————
(laughing)

I mean, I love Gorski, but he comes up with these stupid excuses like, “Well, Burzynski is not an oncologist”
——————————————————————
2:01:00
——————————————————————
Well, Gorski doesn’t go go in there and look at his other, his phase 2 clinical trial publications, as far as the preliminary reports, and look at the co-authors, and see if any of those guys are oncologists, and that they’re working with Gorski, I mean they’re working with Burzynski

I find that ridiculous
——————————————————————
Yeah

One of the things, one of the things that I’ve noticed going through these um, well, well there there is that

Uh, Guy Chapman, “It’s a blog, not a peer-reviewed publication” [79]

Um, almost no treatment goes out without trials

Massive amounts of data are required

Um, so, it it is kind of, slightly disingenuous to hold uh Gorski to the same . . standard that you would, it on his blog

I think that professionally he would make, he he he would follow-up on these things, but u what I’ve noticed when you you mention these other people who are working with with Burzynski as co-investigators, the co- investigators don’t seem to have access to these, to these records
——————————————————————
2:02:00
——————————————————————
Um, you know, when they have to, when a patient has to, and often you have someone like a pediatrician, uh, signing on um uh to eh eh to work with with, uh and arrange care for patients when they’re out of state, away from Burzynski

Um, it’s it’s it’s often not an oncologist

It’s accurate to say that B Burzynski is not a board s uh certified oncologist

It’s accurate to say that no trial has been completed and fully published

Um, yeah it’s um, it it it if, all of the arguing on behalf of Burzynski doesn’t give him a single phase 3

It doesn’t give him um a uh uh of of a completed and and published phase 2

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
——————————————————————
2:03:03
——————————————————————
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
——————————————————————
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
——————————————————————
What is the issue were not talking about
——————————————————————
Hey, I’ve said it to Gorski

He liked to back his stuff up on the Mayo study, yet he wouldn’t, he wouldn’t uh debate about the Mayo study

He likes to say, “Well, Burzynski is not an oncologist,” but he won’t, say Hey, look at the publications, are any of the guys on the publications oncologists ?

We know that Gorski, we know that Burzynski works with oncologists in his practice

So, just because Burzynski himself is not an an oncologist, does not necessarily mean anything

Do we need to go out, onto PubMed, and, and review every particular person that’s published something about cancer and see if they’re all oncologists ?

Seriously
——————————————————————
2:04:11
——————————————————————
I mean, Gorski will just
——————————————————————
Yeah, but they
——————————————————————
post a lot of stuff without backing it up
——————————————————————
But they have track records that support the idea that you should trust them
——————————————————————
Well, (laughing), I, you know, that’s up to someone’s opinion, considering some of the information that’s that the FDA has accepted, as far as giving these guys approval
——————————————————————
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 ?
——————————————————————
How did I say I, I didn’t trust them ?
——————————————————————
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
——————————————————————
Well, I didn’t say that they weren’t trustworthy, I just raised questions that no one wants to answer about ’em
——————————————————————
You’re suggesting that they’re untrustworthy
——————————————————————
No, I’m just sayin’ that I’ve raised questions and none of The Skeptics wanna to uh talk about ’em
——————————————————————
I I would say that the the FDA has given Burzynski every opportunity for decades

Every opportunity

When he didn’t have r r really, he got special treatment as far as I can tell

Uh, the, I’m rather stunned every morning I wake up and don’t see in the paper, that that place has has been closed down

I, I really am

Uh, so, you know,that one doesn’t really fly with me either

Um
——————————————————————
2:06:00
——————————————————————
Well, to me the FDA owes Burzynski for a lot of the garbage they pulled off against him (laugh), not to say, you know, they owe him in that way, but they owed him
——————————————————————
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 ?
——————————————————————
Well, we know a lot stuff they did, but that still doesn’t impress me that they pulled out of the prosecution

I mean
——————————————————————
Yeah, the the the it wasn’t the FDA who was pressing charges, it was a Federal prosecutor
——————————————————————
Right
——————————————————————
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
——————————————————————
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 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
——————————————————————
The, no, claims works

He claims works
——————————————————————
Well, he says they work together and they’re not going to work if you don’t use them that way
——————————————————————
One of the things I think

One of the things that I think is happening here
——————————————————————
(laughing)
——————————————————————
One of the things I think is happening here, is that lots of people have worked with Burzynski and then have stopped working with B Burzynski

Uh, you know, uh lots of uh uh uh these partnerships do not seem to work out in the end

I often wonder, if the uh, the way that these things are, are are playing out, because it’s s so reliable that they’re, that these partnerships are going to fail, I I wonder if th they are designed in such a way, that for instance, um a, uh, a a partner would be uncomfortable working with him
——————————————————————
2:08:18
——————————————————————
Or um or that the specifications for what it takes to enter one of these trials is so high, that nobody will ever enter the trials

I mean, I wonder if they are, what, especially, like why hasn’t Burzynski left the country ?

That’s what I want to know
——————————————————————
Why would he leave the country ?
——————————————————————
Exactly
——————————————————————
I think he’s made it clear
——————————————————————
If he was so, if he was s so persecuted and really cares about getting his treatment out to the world, why wouldn’t he ?
——————————————————————
2:09:00
——————————————————————
They’re, they’re lots of things going on here

David James has pointed this out, that a lot of questions I’m asking are not going answered

“I still don’t know how long it would take before you would have any doubts about Burzynski”

“I still have no idea, how often we can see patients reporting that signs of getting worse are getting better, before you would change your mind”

I’ve made it very clear that he just needs to have a completed study published and replicated before I support his right to go out and charge people what he’s charging for these, for these drugs, and I’m I’m just not seeing that here with you, and I I wonder what could come from, and don’t worry I will go to your site and I will comment on on on what you’ve run

Um, but, you know, I I I I it’s hard for Skeptics to imagine, what could be gained from engaging with you, if there seems to be no conceivable way, that we can, one, get a straight answer for, how many patients will have to report that getting worse is getting better before you starting doubting your opinion, or, uh, how many uh, uh, how many years does this have to go on before you decide that, “No, we probably just can’t produce the goods”
——————————————————————
2:10:15
——————————————————————
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
——————————————————————
Well, I think The Skeptics, Skeptics are falling short because, you know, they don’t own up to
——————————————————————
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
——————————————————————
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
——————————————————————
So I can say that since the Mayo Clinic 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
——————————————————————
Correction: M.D. Anderson
——————————————————————
Why wasn’t that study
——————————————————————
for me to make up my mind (laughing)
——————————————————————
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
——————————————————————
Well I can say, well I’m going to have to wait, the same amount of time I had to wait for Mayo to publish their study; which was from 2006 to 2013
——————————————————————
Clarification: M.D. Anderson
——————————————————————
Why was the Mayo

Why was the Mayo study delayed ?
——————————————————————
How do you know it was delayed ?
——————————————————————
Well you said you had so many years before you finish it and go in

——————————————————————
I mean, has anybody
——————————————————————
Why, why did it take so long ?
——————————————————————
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
——————————————————————
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
——————————————————————
Sure
——————————————————————
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
——————————————————————
Why did it take so long for it, for it to come out
——————————————————————
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
——————————————————————
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
——————————————————————
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
——————————————————————
I I, yeah, the other thing that David James points out is, you know, why 2016 when he’s had 36 years already ?
——————————————————————
Again, we get back to, when the clinical trial is finished, not when Burzynski started
——————————————————————
Treating people
——————————————————————
I mean, you would expect to find a results to be published after, the final results are in
——————————————————————
You would expect the Burzynski Patient Group to be a lot bigger after 36 years, and in fact is
——————————————————————
You would expect some people would want to have confidentiality, and maybe not want to be included
——————————————————————
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”
——————————————————————
Why am I unsure ?
——————————————————————
Uh about the
——————————————————————
(laughing) I just gave you an example
——————————————————————
The reasons, the reasons for which that he’s, no, why are you defending him so hard, when you’re unsure ?
——————————————————————
2:15:02
——————————————————————
Oh, who said I was unsure ?

I just gave you an example

I mean, I’m just, I believe in free and open debate

I mean, I believe, if y’all are gonna spam the Internet, the Internet with garbage that y’all do not back-up, with specific
——————————————————————
I’ve backed-up everything that
——————————————————————
references
——————————————————————
Every time that I’ve tried
——————————————————————
(laughing)
——————————————————————
and then other people
——————————————————————
Like your tweet that said uh, “antineoplastons is uron, is Unicorn pee,” right ?
——————————————————————
Way back

It is about
——————————————————————
(laughing)
——————————————————————
It is about as efficacious

We have the same
——————————————————————
“Burzynski is a vampire”

Good one (laughing)
——————————————————————
Yeah, I’ve, and and I based that on a a a that type of thing
——————————————————————
He sucks their blood out of ’em right ?

Yeah (laughing)

Humor

Okay, I understand humor
——————————————————————
You, you, you can read that how you want, right ?
——————————————————————
(laughing)
——————————————————————
There

He does have the accent though

Right ?

No (laugh)
——————————————————————
Well, that’s because he’s Polish
——————————————————————
(laughing)

Alright ?

No, but listen, like, it it it’s not, it, we we don’t understand why you defend himself so hard, when there is such a paucity of of of information out there

Um
——————————————————————
2:16:09
——————————————————————
What I defend, is that, y’all post stuff, a lot of Skeptics post stuff, including Gorski, and they do not back it up, with references, citations, or links

Gorski will just post stuff, like he did about saying, you know, the FDA would not approve, uh, accelerated approval, without a final phase 2 clinical trial being published, which was an incorrect statement, he did not provide any link
——————————————————————
Even if it’s true or false you, honestly though
——————————————————————
We know it’s false
——————————————————————
Even if it’s true or false, in in that particular instance, you know, eh let’s just say that you’re right

Gorski gets that point completely wrong

It has no bearing on whether or not, ANP works
——————————————————————
Well, I’m just
——————————————————————
That’s a Red Herring
——————————————————————
I’m just
——————————————————————
You’re just focusing on this, on this little niggly stuff, where the real question, is does it work ?
——————————————————————
Not
——————————————————————
Are patients getting better at a better rate then not
——————————————————————
2:17:01
——————————————————————
That’s
——————————————————————
or otherwise ?
——————————————————————
Well, that is just lame
——————————————————————
Y’all, Skeptics, like to sh spam Twitter, and social media, with all this negative stuff about Burzynski, but then when I ask you to back it up, you can’t back it up, and then, and then on this conversation you want to come down and pinhole it, to a specific subject, you know, the nitty-gritty

Well, if y’all were only debating the nitty-gritty, we would only be d debating the nitty-gritty, but that’s not what y’all do
——————————————————————
We’re were talking about whether or not there’s evidence to suggest it works
——————————————————————
Well, we know the FDA’s said there is
——————————————————————
The FDA, see that’s the thing

You, the FDA are are, you know, you invest them with, we’re just, we’re just circling around again
——————————————————————
(laughing)
——————————————————————
Uh um, alright

Well, this has gone on for rather a, longer than I thought it would
——————————————————————
2:18:00
——————————————————————
Um, I, uh, wanna thank you for coming on here

I wasn’t sure that you would actually do it

Um, I’m glad that you did

I’m glad that we talked

Um, I will look at your web-site, and we will, uh, we, uh, you, oh make sure that I I go to your blog and and I talk there

Um
——————————————————————
And I’ll give you those links that I told you I would give you
——————————————————————
Please do

And I will look at those

Maybe not in the next few days; I’ve got a lot going on but
——————————————————————
Yeah, that’s fine
——————————————————————
Alright

Um
——————————————————————
Well, I thought it was productive too

You know, I don’t see why Gorski is afraid of debating issues
——————————————————————
I don’t think he is
——————————————————————
on the Internet, on his blog
——————————————————————
I don’t think he’s afraid

I just think he’s got a lot going on

He is act, a full-time surgical oncologist and researcher

He does have insane am, he has to pick and choose his battles

And if, if if he saw that we were going to ultimately be circling around our same arguments again and again; kind of like we’ve done here, um, he uh, you, he doesn’t have time for that, I don’t think
——————————————————————
2:19:00
——————————————————————
I mean
——————————————————————
Hey, he has time to post about, “Hey, uh, Burzynski got a Catholic award from somebody,” which, has nothing to do with antineoplastons, whatsoever

So, you know, he’s not focusing just in on, “Do antineoplastons work, yes or no?,” “When will Burzynski publish ?,” yes or no ?

You know, he’s putting all this ridiculous side junk, you know

So, I am not going to take that seriously
——————————————————————
Alright

I I would ask that you to to go back over The The Other Burzynski Patient Group and take their stories seriously, because they deserve at least the same amount of consideration that the survivors do

That’s my
——————————————————————
Exactly
——————————————————————
That’s my kids, okay

Well, Thanks for much for talking

I greatly appreciate it
——————————————————————
You bet

Thank you
——————————————————————
Alright

Take it easy
——————————————————————
You too
====================================
====================================
END
====================================
====================================
I thought that this was very productive, because it proved that Randy Hinton was correct when he commented on #Forbes:

“[Y]ou people always control the conversation
====================================
======================================
REFERENCES:
======================================
====================================
[0] – Bobby Blaskiewicz Bows Up ‘Bout Burzynski:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/24/bobby-blaskiewicz-bows-up-bout-burzynski/
======================================
[1] – 9/28/2013 – Burzynski discussion: By Bob Blaskiewicz – 2:19:51
——————————————————————
http://m.youtube.com/?client=mv-google#/watch?v=pa97hXMbUL0
======================================
[2] – The Skeptics™” Robert J. (don’t call me “Bobby”) Blaskiewicz wants to Debate:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/27/the-skeptics-robert-j-dont-call-me-bobby-blaskiewicz-wants-to-debate/
======================================
[3] – “The Skeptics” are “debatable”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/29/the-skeptics-are-debatable/
======================================
[4] – Bob Burzynski Skeptic Sez Multiforme Manuscript Meme Message Memorable:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/30/bob-burzynski-skeptic-sez-multiforme-manuscript-meme-message-memorable/
======================================
[5] – What to do when a Burzynski Skeptic suggests you not do it:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/01/what-to-do-when-a-burzynski-skeptic-suggests-you-not-do-it/
======================================
[6] – “The Skeptics™” Definition of “Debate”
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/03/the-skeptics-definition-of-debate/
======================================
[7] – A Message to Guy “Can’t Git-R-Done” Chapman:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/03/a-message-to-guy-cant-git-r-done-chapman/
======================================
[8] – About | Didymus Judas Thomas’ Hipocritical Oath Blog
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/about/
======================================
[9] – 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/
======================================
[10] – Critiquing: The Institute of Medicine report on cancer care: Is the system “in crisis”?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/21/critiquing-the-institute-of-medicine-report-on-cancer-care-is-the-system-in-crisis/
======================================
[11] – 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/
======================================
[12] – Burzynski Securities and Exchange Commission (SEC) Links:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/29/burzynski-securities-and-exchange-commission-sec-links/
——————————————————————
http://www.itnonline.com/article/fda-approves-trial-radiation-therapy-brain-stem-glioma
======================================
[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/
======================================
[14] – 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/
======================================
[15] – The Guardian: Censorship and Bias – Six stubborn myths about cancer:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/31/the-guardian-censorship-and-bias-six-stubborn-myths-about-cancer/
======================================
[16] – Critiquing: Amelia’s family ‘mislead by cancer clinic’:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/23/critiquing-amelias-family-mislead-by-cancer-clinic/
======================================
[17] – Critiquing: Watford Observer – ‘He said he hoped to cure my daughter’:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/22/critiquing-watford-observer-he-said-he-hoped-to-cure-my-daughter/
======================================
[18] – Review Articles on Clinical Trials:

1. 3/2004 – The Present State of Antineoplaston Research

Integrative Cancer Therapies 2004;3:47-58
Volume 3, No. 1, March 2004

DOI: 10.1177/1534735-403261964

Volume 3 Number 1.March.2004

Pg. 50
——————————————————————
http://www.burzynskiclinic.com/images/stories/Publications/994.pdf
======================================
[19] – Antineoplastons: Adverse Effects:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/02/antineoplastons-adverse-effects/
======================================
[20] – 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/
======================================
[21] – Critiquing: Dr. David H. “Orac” Gorski, M.D., Ph.D, LIAR: Stanislaw Burzynski versus the BBC:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/04/critiquing-dr-david-h-orac-gorski-m-d-ph-d-liar-stanislaw-burzynski-versus-the-bbc/
======================================
[22] – Critiquing: Dr. David H.
“Orac”Gorski, M.D., Ph.D, L.I.A.R.:

——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/07/critiquing-dr-david-h-orac-gorski-m-d-ph-d-l-i-a-r/
======================================
[23] – 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/
======================================
[24] – Burzynski: Institutional Review Board (IRB):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/02/burzynski-institutional-review-board-irb/
======================================
[25] – Critiquing https://theotherburzynskipatientgroup.wordpress.com
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/24/critiquing-httpstheotherburzynskipatientgroup-wordpress-com/
======================================
[26] – WHAT IS MISDIRECTION? Critiquing
“Antineoplastons: Has the FDA kept its promise to the American people ?”

——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/08/what-is-misdirection-critiquing-antineoplastons-has-the-fda-kept-its-promise-to-the-american-people/
======================================
[27] – Burzynski: HYPERNATREMIA:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/24/burzynski-hypernatremia/
======================================
[28] – Wayne State University, Detroit, Michigan, quickly realized that David H. Gorski, MD, PhD, FACS is NOT doing something wrong when he LIES about Burzynski:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/27/wayne-state-university-detroit-michigan-quickly-realized-that-david-h-gorski-md-phd-facs-is-not-doing-something-wrong-when-he-lies-about-burzynski/
======================================
[29] – Burzynski: Egypt antineoplaston publications:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-egypt-antineoplaston-publication/
======================================
[30] – Burzynski: Russia antineoplaston publications:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-russia-antineoplaston-publications/
======================================
[31] – Burzynski: Poland antineoplaston publications:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-poland-antineoplaston-publications/
======================================
[32] – Burzynski: China antineoplaston publications:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-china-antineoplaston-publications/
======================================
[33] – Burzynski and China / Taiwan, ROC:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/02/18/burzynski-china-taiwan-roc/
======================================
[34] – Burzynski and Taiwan, ROC:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/02/20/burzynski-taiwan-roc/
======================================
[35] – 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/
======================================
[36] – Burzynski Securities and Exchange Commission (SEC) Links:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/29/burzynski-securities-and-exchange-commission-sec-links/
======================================
[37] – Burzynski: Japan antineoplaston publications:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/02/19/burzynski-japan/
======================================
[38] – Critiquing the #SkepticCanary: “The Skeptics™” (SkeptiCowards©) Bob Blatherskitewicz and the so-called, self-proclaimed “Cancer Researcher“:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/03/critiquing-the-skepticcanary-the-skeptics-skepticowards-bob-blatherskitewicz-and-the-so-called-self-proclaimed-cancer-researcher/
======================================
[39] – 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/
======================================
[40] – 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/
======================================
[41] – What to do when a Burzynski Skeptic suggests you not do it:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/01/what-to-do-when-a-burzynski-skeptic-suggests-you-not-do-it/
======================================
[42] – Critiquing “When is a skeptic not a skeptic”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/05/26/critiquing-when-is-a-skeptic-not-a-skeptic/
======================================
[43] – Critiquing: In which Orac does Stanislaw Burzynski propagandist Eric Merola a favor…:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/22/critiquing-in-which-orac-does-stanislaw-burzynski-propagandist-eric-merola-a-favor/
======================================
[44] – Galileo’s Lawyer
——————————————————————
http://www.richardjaffe.com/jaffe/
======================================
[45] – Burzynski: The Original 72 Phase II Clinical Trials:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/09/burzynski-the-original-72-phase-ii-clinical-trials/
======================================
[46] – Critiquing “Burzynski: Another fact-blind troll, who predicted that?”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/24/critiquing-burzynski-another-fact-blind-troll-who-predicted-that/
======================================
[47] – My review of “Burzynski: A note to the PBS ombudsman”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/23/my-review-of-burzynski-a-note-to-the-pbs-ombudsman/
======================================
[48] – guychapman (Guy Chapman) Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 9):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/05/05/guychapman-guy-chapman-critiquing-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics-page-9/
======================================
[49] – I find Rhys Morgan abnormally prehensile:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/20/i-find-rhys-morgan-abnormally-prehensile/
======================================
[50] – 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/
======================================
[51] – I show JzG what a
“FACT”
is: Burzynski: FAQ (Frequently Asked Questions): Clinical Trial Results:

——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/05/14/i-show-jzg-what-a-fact-is-burzynski-faq-frequently-asked-questions-clinical-trial-results/
======================================
[52] – Dr. Peter A. Lipson (and / or his Censor(s)) is a Coward: Critiquing “A Film Producer, A Cancer Doctor, And Their Critics”:
——————————————————————
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/
======================================
[53] – IMPORTANT: The live “debate” that wasn’t-A Film Producer, A Cancer Doctor, And Their Critics:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/29/important-the-live-debate-that-wasnt-a-film-producer-a-cancer-doctor-and-their-critics/
======================================
[54] – “The Skeptics:” Your problem is, Wikipedia IS censored:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/14/the-skeptics-your-problem-is-wikipedia-is-censored/
====================================
[55] – Wikipedia, what’s your motivation?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/05/02/wikipedia-whats-your-motivation/
====================================
[56] – WikipediA or WikipediAin’t ?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/05/16/wikipedia-or-wikipediaint/
====================================
[57] – Wikipedia, your Burzynski BIAS is showing:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/05/18/wikipedia-your-burzynski-bias-is-showing/
====================================
[58] – Wikipedia, you’ve sprung a Wiki Leak:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/05/21/wikipedia-youve-sprung-a-wiki-leak/
====================================
[59] – On the 6th day, HE created WIKIPEDIA, and on the 7th, WikipedBiaS:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/05/30/on-the-6th-day-he-created-wikipedia-and-on-the-7th-day-wikipedbias/
====================================
[60] – Wikipedia, do you serve up Mud Pies with your Wikipedia Lies ?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/05/31/wikipedia-do-you-serve-up-mud-pies-with-your-wikipedia-lies/
====================================
[61] – Critiquing: Wikipedia – Burzynski Clinic:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/10/critiquing-wikipedia-burzynski-clinic/
====================================
[62] – Critiquing Wikipedia: Burzynski Clinic, Colorado Public Television (CPT12), and Public Broadcasting System (PBS)
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/12/critiquing-wikipedia-burzynski-clinic-colorado-public-television-cpt12-and-public-broadcasting-system-pbs/
====================================
[63] – A Critical Analysis of Wikipedia’s “Failure to Communicate”
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/13/a-critical-analysis-of-wikipedias-failure-to-communicate/
====================================
[64] – Critiquing Wikipedia: Burzynski Clinic – 2013 BBC documentary, Curing cancer or ‘selling hope’ to the vulnerable?
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/22/critiquing-wikipedia-burzynski-clinic-2013-bbc-documentary-curing-cancer-or-selling-hope-to-the-vulnerable/
======================================
[65] – Josephine Jones and the Cult of Misinformation:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/13/josephine-jones-and-the-cult-of-misinformation/
======================================
[66] – The Burzynski Skeptics:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/18/the-burzynski-skeptics/
======================================
[67] – “The Skeptics” (Burzynski: Cancer is Serious Business, Part II) |:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/24/the-skeptics/
====================================
[68] – Critiquing the Skeptics re “Funny how you never see Orac and this person in the same place at the same time”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/02/critiquing-the-skeptics-re-funny-how-you-never-see-orac-and-this-person-in-the-same-place-at-the-same-time/
====================================
[69] – “The Skeptics”-Tracking the Twits that Tweet:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/the-skeptics-tracking-the-twits-that-tweet/
====================================
[70] – Shall We Play A Game? “The Skeptics” (SkeptiCowards) vs. “The Skeptics’” Critics #Burzynski The 1st ever “LIE OFF”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/05/23/shall-we-play-a-game-the-skeptics-skepticowards-vs-the-skeptics-critics-burzynski-the-1st-ever-lie-off/
====================================
[71] – “The Skeptics” Theme Song:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/05/25/the-skeptics-theme-song/
====================================
[72] – Thawing out “The Skeptics” @FrozenWarning (FrozenBoring):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/01/thawing-out-the-skeptics-frozenwarning-frozenboring/
====================================
[73] – “The Skeptics™” Doctor David H. Gorski is one of the “SkeptiCowards©” (I kid you not): Houston, We Have a Problem:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/02/the-skeptics-doctor-david-h-gorski-is-one-of-the-skepticowards-i-kid-you-not-houston-we-have-a-problem/
====================================
[74] – 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/
====================================
[75] – The Burzynski Skeptics:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/18/the-burzynski-skeptics/
====================================
[76] – Critiquing: Stanislaw Burzynski comments on new cancer science, hilarity ensues because of The Skeptics™ comments:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/11/critiquing-stanislaw-burzynski-comments-on-new-cancer-science-hilarity-ensues-because-of-the-skeptics-comments/
====================================
[77] – 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/
====================================
[78] – The Skeptics @Majikthyse reveals madjik research skilz:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/26/the-skeptics-majikthyse-reveals-madjik-research-skilz/
====================================
[79] – The dishonesty of Guy Chapman, “The Skeptics” shill:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/12/the-dishonesty-of-guy-chapman-the-skeptics-shill/
====================================
======================================
[80] –

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Critiquing: The Institute of Medicine report on cancer care: Is the system “in crisis”?

[1] – 9/19/2013 – “Americans love to fight, traditionally”

“All real Americans love the sting and clash of battle…When you, here, everyone of you, were kids, you all admired the champion marble player, the fastest runner, the toughest boxer, the big league ball players, and the All-American football players”

“Americans love a winner”

“Americans will not tolerate a loser”

– General George S. Patton, Jr., June.5, 1944

The above might as well be Greek to Dr. David H. Gorski a/k/a “Orac”

He’s the epitome of the word “loser”

Indeed, “Orac” described his work-place nemesis as “user hostile”

After 5 years, he still didn’t fully understand much of it, and he claims he’s not exactly computer illiterate

Gorski is that “guy” who couldn’t even find Burzynski’s publication:

[2] – 1997 – Burzynski. S.R. Antineoplastons. oncogenes and cancer

[3] – “Orac” batted the big “O” when he tried to find “the scientific rationale to expect that” antineoplastons “might have antitumor activity”

[4] – Gorski was geniusless when it came to finding “which genes are targeted by antineoplastons,“ proving that he really does NOT know Burzynski’s personalized gene-targeted therapy

In fairness, I will point out that he hasn’t put the time in to learn all the ins and outs of the system …

He pontidefecates about phase II clinical trials when his name isn’t even on a phase 2 trial, too

[5] – 9/19/2013 – He’s the “guy” who’s “mystified” as to how Stanislaw Burzynski “has managed to keep practicing for 36 years after he first began treating patients with an unapproved (not ordinary) chemotherapeutic drug (the concoction of peptides purportedly isolated from blood and urine that Burzynski dubbed “antineoplastons” because of their alleged ability to inhibit the growth of cancer)”

This is not an issue unique to Gorski; I’ve discussed other cases like this, such as Bobby Blaskiewicz, who used his man-crush relationship with Gorski to appear on the Skeptic Canary Show; Davey James, who was only recently stripped of his license to practice in several states of mind; Adam Jacobs, who went so far as to use his business influence to alter his Dianthus Mediclueless web-site in London to be more hack friendly, and an interventist who administered twerkpidity to posers who didn’t have common sense and defrauded minions for tens of millions of minutia

It’s a general problem

However, as far as doctors who should have been shut down a long time ago, “Orac” takes the cake

[6] – He has NOT yet figured out that Burzynski learned from the best

[7] – Who could do it better than someone like 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) who Burzynski had to deal with:

“This is, as you point out, a most serious matter, and I was hoping that you could allay my concerns by showing me where they are unfounded

“However, your letter conspicuously fails to address them

“You also make reference to “numerous factual misstatements” but fail to identify any of them, much less provide documentation to show they are false”

Pg. 2

“I am glad that you plan to “thoroughly examine the accusations” I have made”

“I also eagerly await a substantiative response to the points raised in my letter of 4/20/1995”

20130920-220216.jpg

20130920-220507.jpg
After all, can we really take a person seriously, who claimed:
——————————————————————
[8] – 11/2/2012 – “Personally, having pored over Burzynski’s publications … “
——————————————————————
[9] – 5/8/2013 – “I’ve searched Burzynski’s publications … “
——————————————————————
[10] – 6/5/2013 – “ … I do know cancer science”
——————————————————————
Uhhhhhhh … yeah

But do you really know Burzynski’s cancer science when you did NOT even know:

“which genes are targeted by antineoplastons“?

Has “GOraCON” (“Orac” + @Gorskon) even read these ?
——————————————————————
[11] – 10/2003 – Waldbillig R, Burzynski SR. Mechanism of action, uptake, and gene array studies on the antineoplastic agent phenylacetylglutamine (PG) in human glioma cells U-87. Neuro-Oncology. 2003; 5: 309

Volume 5 Issue 4 October 2003

(genes CD38, OASL, and TCF8)
——————————————————————
[12] – 10/2007 – Patil, S., Burzynski, S.R., Mrowczynski, E., Grela, K. Phenylacetylglutamine (PG) and phenylacetate (PN) interact additively to produce detachment-induced apoptosis/anoikis in glioblastoma cells. Neuro-Oncology 2007; 9:482

Volume 9 Issue 4 October 2007

We have conducted a total human gene array screen using the Affymetrix Human Genome plus 2.0 oligonucleotide arrays, for genes regulated by PG and a combination of PG and PN

gene TXNIP was up-regulated almost 5-fold with PG, and almost 120-fold using a combination of PG and PN

genes that are significantly up-regulated are CLDND1, ATF3, CASP5, TP53, TRIB3, and UNC5B

Genes that were down-regulated include AKT2, ASPM, CDCA8

(caspase 5, p53, netrin receptor) and AKT pathway (AKT2, TRB3)
——————————————————————
[13] – 10/2008 – Patil, S., Burzynski, S., Chittur, S., Mrowczynski, E., Grela, K. Antineoplaston AS2-1 affects cell cycle checkpoints, leading to apoptosis in human glioblastoma cells. Neuro-Oncology 2008; 10:786

Volume 10 Issue 5 October 2008

Affymetrix Human Genome

CDCs 25A and 25B, cyclins D3 and E, and CDKs 3, 4, and 6

ORC1L and CDC6

MCMs 2, 3, 4, 5, 6, and 7, and CDC7

cyclins A, B1, and B2, polykinase 1, and CDKs 1 and 2

MAD2L1, BUB1 and CDC20

p21, p53, and GADD45A

p21/CDKN1A, and PPM1A

Based on pathway analysis, it was observed that anti-neoplastons affected the expression of more than 40 genes instrumental in the cell cycle in GBM cells
——————————————————————
[14] – 12/2008 – Patil, S., Burzynski, S., Chittur, S., Mrowczynski, E., Grela, K. The ingredients of antineoplaston AS2-1 down-regulate glycolysis pathways in glioblastoma cells. Neuro-Oncology 2008; 10:1148

Volume 10 Issue 6 December 2008

In 2004 the FDA granted orphan drug designation for antineoplastons A10 and AS2-1 for the treatment of brainstem glioma

12 FDA-supervised phase II clinical trials have confirmed anti-tumor efficacy in several types of brain tumors

A total human gene array screen using the Affymetrix Human Genome

The expression of mRNA for vitamin D3 up-regulated protein 1 (VDUP1) was found to be over 100 fold higher for cells treated with PG and PN

succinate dehydrogenase C (SDHC), fumarate hydrogenase (FH), succinate-CoA ligase 1 and 2 (SUCLG1and 2), and aconitase 2 (ACO2)
——————————————————————
[15] – 11/2010 – Patil S, Burzynski SR, Mrowczynski E, Grela K. Targeting MicroRNAs in Glioma Cells with Antineoplastons. Neuro-Oncology 2010; 12, iv10

Volume 12 Supplement 4 November 2010

This study was done using the Dharmacon mRNA profiling array (Thermo Fisher Scientific)

mRNAs 125a-5p and 125a-3p

mRNAs 125a-5p has recently been shown to be regulated by the epidermal growth factor receptor and to function as a tumor suppressor in lung cancer

It has also been shown that the over-expression of mRNA 125a or mRNA 125b caused reduced migration and invasion of SKBR3 breast cancer cells

Using the total human microarray screen (Affymetrix)

AKT2
——————————————————————
[16] – 6/2012 – Sonali, S. Patil, Stanislaw R. Burzynski, Emilia Mrowczynski, Krzysztof Grela, Sridar V. Chittur. Phenylacetylglutaminate and Phenylacetate in combination Upregulate VDUP1, cause cell cycle blockade and Apoptosis in U87 Glioblastoma cells. Journal of Cancer Therapy 2012;3:192-200
——————————————————————
[17] – 9/2012 – Patil, S., Burzynski S.R., Mrowczynski, E., Grela, K. P.003. Phenylacetylglutaminate in combination with Phenylbutyrate effectively inhibits growth of brain tumor cell In Vitro. Neuro-Oncology 2012;14(Suppl. 3):iii16

Volume 14 Supplement 3 September 2012

The FDA granted Orphan Drug designation for Antineoplastons A10 and AS2-1 for the treatment of gliomas, in 2009

12 FDA-supervised Phase II clinical trials have confirmed anti-tumor efficacy in several types of brain tumor

AKT2

PG is not toxic to normal cells whereas PB has dose-limiting neuro-cortical toxicity
——————————————————————
Cancer care: Is the system “in crisis” ?

The Institute of Medicine, just in case you’re like “Orac” and have NOT yet figured it out, “the system” has been “in crisis” since the Gubment “forgot” who they are here to serve

[18] – Gorsi, maybe you can explain to The Institute of Medicine why the Cancer care system is “in crisis” because M.D.’s with Ph.D’s who hold positions “at an NCI-designated comprehensive cancer center,”are responsible for massive fact-checking #FAILS

What did you do, Gorski ?

Phone It in again ?
======================================
REFERENCES:
======================================
[1] – 9/19/2013 – The Institute of Medicine report on cancer care: Is the system “in crisis” ?
——————————————————————
http://scienceblogs.com/insolence/2013/09/19/the-institute-of-medicine-report-on-cancer-care-is-the-system-in-crisis/
======================================
[2] – 1997 – Critiquing: Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/26/x/
======================================
[3] – Critiquing: Dr. David H. “Orac” Gorski and The Skeptics™
http://www.scienceblogs.com/Insolence
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/08/critiquing-dr-david-h-orac-gorski-and-the-skeptics/
======================================
[4] – Critiquing: Dr. David H. “Orac” Gorski, M.D., Ph.D, L.I.A.R.:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/07/critiquing-dr-david-h-orac-gorski-m-d-ph-d-l-i-a-r/
======================================
[5] – 9/19/2013 – Another case of the failure of physician regulation endangering patients
——————————————————————
http://scienceblogs.com/insolence/2013/09/19/another-case-of-the-failure-of-physician-regulation-endangering-patients/
======================================
[6] – Critiquing: Dr. Michael A. Friedman, 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/
======================================
DID Dr. Michael A. Friedman FIB?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/18/did-dr-michael-a-friedman-fib/
======================================
Dr. Michael A. Friedman, DATA ?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/19/dr-michael-a-friedman-data/
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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/
======================================
[8] – 11/.2/2012
——————————————————————
http://scienceblogs.com/insolence/2012/11/02/stanislaw-burzynski-fails-to-save-another-patient/
======================================
[9] – 5/8/2013
——————————————————————
http://scienceblogs.com/insolence/2013/05/08/eric-merola-and-stanislaw-burzynskis-secret-weapon-against-the-skeptics-fabio-lanzoni-part-2/
======================================
[10] – 6/5/2013
——————————————————————
http://scienceblogs.com/insolence/2013/06/05/odds-and-ends-about-burzynski-clinic/
======================================
[11] – 10/2003
——————————————————————
http://www.burzynskiclinic.com/images/stories/Publications/971.pdf
======================================
[12] – 10/2007
——————————————————————
http://www.burzynskiclinic.com/images/stories/Publications/5169.pdf
======================================
[13] – 2008
——————————————————————
http://www.burzynskiclinic.com/images/stories/Publications/7854.pdf
======================================
[14] – 2008
——————————————————————
http://www.burzynskiclinic.com/images/stories/Publications/7897.pdf
======================================
[15] – 11/2010
——————————————————————
http://www.burzynskiclinic.com/images/stories/Publications/8636.pdf
======================================
[16] – 6/2012
——————————————————————
http://www.burzynskiclinic.com/images/stories/Publications/9219.pdf
——————————————————————
Journal of Cancer Therapy, 2012, 3, 192-200
doi:10.4236/jct.2012.33028 Published Online June 2012
5. Acknowledgements
This study was supported by and carried out at the Burzynski research Institute (BRI), Houston TX, USA. The Microarray assay was supported by BRI and carried out at Center for Functional Genomics, University of Albany, NY, USA
======================================
[17] – 9/2012
——————————————————————
http://www.burzynskiclinic.com/images/stories/Publications/9291.pdf
======================================
http://www.burzynskiclinic.com/scientific-publications.html
======================================
[18] – Wayne State University, Detroit, Michigan, quickly realized that David H. Gorski, MD, PhD, FACS is NOT doing something wrong when he LIES about Burzynski:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/27/wayne-state-university-detroit-michigan-quickly-realized-that-david-h-gorski-md-phd-facs-is-not-doing-something-wrong-when-he-lies-about-burzynski/
======================================

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

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
======================================
[24] – 1995 (10/27/1995) – Burzynski 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH)

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

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

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

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

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

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

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

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

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

Cancernet then compounds that misstatement with the following:

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

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

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

The next misstatement is the following:

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

Pg. 2

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

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

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

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

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

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

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

But by far the most outrageous misstatement is the following:

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

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

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

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

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

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

The above is all well documented

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

Dr. Friedman specifically agreed to exclude patients with:

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

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

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

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

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

Pg. 3

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

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

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

In fact, NCI went even further

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

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

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

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

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

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

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

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

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

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

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

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

It improved only after DPH was discontinued

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

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

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

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

And he disregarded his own misstatements of fact by saying that

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

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

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

Pg. 4

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

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

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

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

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

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

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

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

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

Thank you for your attention to this matter

SRB/cf

cc:

3+ pgs cc:
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20130920-130547.jpg
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1993 (11/2/1993) – Dr. Michael Friedman to Burzynski
1994 (2/17/1994) – NCI “fact sheet”
1994 (3/23/1994) – Dr. Mario Sznol to Burzynski
1994 (4/19/1994) – Burzynski to Dr. Mario Sznol
1995 (1/31/1995) – Dr. John L. Lewis
1995 (4/3/1995) – Dr. Mario Sznol to Burzynski
1995 (8/18/1995) –
1995 (8/23/1995) – Robert B. Lanman to Burzynski
1995 (9/19/1995) – Dr. Michael A. Friedman to Burzynski
1995 (10/5/1995) – Robert B. Lanman to Burzynski
======================================

[19] – 1995 (6/6/1995) Dr. Michael A. Friedman to Burzynski (3 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/
======================================
[19] – 1995 (6/6/1995) – Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health and Human Services (HHS), Public Health Service, National Institutes of Health (NIH) 3 page letter to Burzynski

This letter is intended to respond to the major issues which have been raised in your recent correspondence of 4/20/1995 and 5/16/1995

Your accusations are serious and require comment

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 had evidence of focal glioblastoma multiforme on the biopsy reviewed at the NCI

A different specimen submitted to Dr. Rorke may or may not be relevant

This patient, however, had a brain scan 3 weeks prior to study entry

Patient .27-53-76-5 had a tumor which was 0.8 cm larger than the eligibility criteria dictated

Although pharmacologic data were obtained on both, neither patient is counted in an assessment of response

Both patients had objective tumor progression and are now off study

With respect to the other patients, I am including specific patient summaries from the treating investigators which address your other concerns; in particular, a response to your serious and unfounded statement that patient #196370 was treated in an unethical manner

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)

Having provided this information, I must convey my deep pessimism about the potential for continued interactions with you regarding these trials

Given recent events and your clearly articulated bias that the Mayo Clinic, Memorial Sloan Kettering Hospital and even the National Cancer Institute could not fairly test your product

(please see your letters of 10/26/1993 and 4/20/1995),

I now see a diminishing chance for a productive dialogue with you

Historically, the NCI has demonstrated pragmatism and flexibility in working with a wide variety of individuals and organizations to explore diverse interventions of potential benefit to the cancer patient

However, such a fruitful collaboration may simply not be possible with you

Pg. 2

The decision to suspend the NCI antineoplaston studies was reached by the investigators and the NCI and was explained in our letter of 5/12/1995

(see enclosed)

While we have frequently solicited your advice, we are in no way obligated to obtain your consent

Our interactions with you have been similar to those with pharmaceutical companies or other independent investigators

In the interest of testing antineoplastons, we have consistently considered your advice and recommendations but that in no way cedes control of these studies to you

(please refer to our letters of 7/15/1993, 10/20/1993, and 11/2/1993)

Your insistence on dictating the manner in which we conduct our review of these clinical trials is both presumptuous and inappropriate

The future of these trials rests entirely with the investigators and the NCI, since our primary obligation is to the American public

Recognizing your potential conflict of interest as the developer and the most visible proponent of antineoplastons, we could not responsibly act in any other manner

In contrast to the tenor of your unsupported statements, the NCI bases its position on scientific data

You have stated that you have a vast clinical experience with antineoplastons and we have generally been deferential to your demands despite the lack of substantive data

However, our scientific standards are broadly applied to all studies

The data and level of proof we require from you is much the same as that for other professional collaborators who make such claims

The 7 case records initially examined by the NCI hardly constitute a definition scientific result

It is naive and misleading for you to suggest that the experience of 2 of those patients who had tumors in excess of 5 cm provides adequate proof for all your contentions about tumor size, dose, etc., unless these were the only 7 brain tumor patients from your entire experience who had any hint of benefit

To be precise, in order to responsibly and properly assess your claims and accusations (as per your 4/20/1995 letter), we request that you provide the following information:

1. Exactly how many adult patients with primary brain tumors have you evaluated and treated with antineoplastons?

2. When analyzed by histological type, performance status, prior therapy, concurrent therapy (including chemotherapy), disease size and focality, how many adult brain tumor patients had objective responses?

Please characterize the quality and magnitude and duration of these responses

3. What dose, duration, schedule, and composition of antineoplastons did these patients receive?

Which of these patients benefited objectively?

What toxicities were encountered?

Do you have pharmacokinetic or pharmacodynamic data to support your contention that certain types of brain tumor patients require specific regimens?

4. For these patients, what statistical analyses relate patient or tumor characteristics with exact treatment regimen and outcome?

Pg. 3

If you provide such specific data, we can properly assess your claims

Lacking such information, we cannot

Moreover, your charges that patients received inappropriate care are not supportable without such detailed information

If, after careful consideration, the investigators at Memorial Sloan Kettering and Mayo Clinic do not reopen their studies, it is unlikely that the NCI will attempt to conduct further antineoplaston trials

Any unused antineoplaston material will, of course, be returned to you

Since we can make no judgement about the benefit or toxicity of antineoplastons at this time, we will be interested in the published outcome of peer reviewed studies that you or others may perform

If the NCI investigators choose to continue these studies, you will be so informed

In either circumstance, we will continue to sponsor clinical research of small molecules that may have differentiating properties (such as pure phenylacetate and phenylbutyrate)

cc:

Senator Joseph Biden
Senator Barbara Boxer
Senator Diane Feinstein
Senator Tom Harkin
Senator Barbara Mikulski
Congressman Berkley Bedell
Congresswoman Nancy Pelosi
Dr. Jan Buckner
Dr. Jay Greenblatt
Mr. Richard Jaffe
Dr. Wayne Jonas
Mr. Robert Lanman
Ms. Mary McCabe
Dr. Mark Malkin
Dr. Tony Murgo
Dr. Ralph Moss
Dr. David Parkinson
Dr. Edward Sondik
Dr. Mario Sznol
Dr. Dorothy Tisevich
Dr. Alan Trachtenberg
Mr. Frank Wiewel
Dr. Robert Wittes
——————————————————————

======================================
1993 (10/26/1993) – Burzynski to
1994 (3/9/1994) –
1994 (7/1994) – Burzynski to Theradex
1995 (4/20/1995) – Burzynski to
1995 (5/12/1995) – to Burzynski
1995 (5/16/1995) – Burzynski to
======================================

[18] – 1995 (5/16/1995) – Burzynski to Dr. Michael A. Friedman

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/
======================================
[18] – 1995 (5/16/1995) – Burzynski letter to Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), National Institutes of Health (NIH)

Thank you for your letter of 5/12/1995

You are correct in asserting that I raise issues of ethical misconduct, failure to obtain adequate informed consent and scientific misjudgment

To be exact, my letter points out specific violations of the clinical trial protocol made by the current investigators

I provided careful documentation of some of the most egregious violations, including the removal of a patient from the study who had no increase in tumor size and the inclusion of a patient with tumor pathology that did not meet the entry criteria

It seems possible that, in at least one one of these cases, failure to follow the protocol resulted in the patient’s unnecessary death

In this case, the patient was removed from the study following an MRI dated 5/2/1994

The conclusion of neuroradiologist Jim Cain, MD, is that this MRI shows that the tumor had not grown, and no new tumors are present

As you know, the protocol calls for patients to be taken off treatment if the tumor grows 50% or more, or a new tumor is present

This is, as you point out, a most serious matter, and I was hoping that you could allay my concerns by showing me where they are unfounded

However, your letter conspicuously fails to address them

You also make reference to “numerous factual misstatements” but fail to identify any of them, much less provide documentation to show they are false

Pg. 2

Contrary to another of your statements, I did provide “specific clinical data which support” my contention that patients with large tumors do not respond well to the current protocol

Let me repeat from here

In the 1991 NCI review of 7 brain tumor cases, the only 2 patients with tumor size greater than 5.1 cm were also the only 2 patients to have less than 50% reduction of their tumor

The correlation between large tumor size and failure to respond is obvious

I am happy to learn that the trials have been put on hold

I must insist that they not be re-activated until I am satisfied that new investigators have been found who are capable of following the protocol — the original protocol on which we both agreed

As you know, the protocol was changed without anyone bothering to seek my advice, and certainly without my consent

I am glad that you plan to “thoroughly examine the accusations” I have made

However, this review must not be done by the people responsible for the violations being investigated

This would amount to a whitewash of the whole affair, and is unacceptable

The review must be done by an independent body of experts acceptable to both of us

Otherwise it will be meaningless

I still have not received the complete data on the 1st 5 patients, which was promised in your letter of 4/3/1995

I hope to receive the data soon

I also eagerly await a substantiative response to the points raised in my letter of 4/20/1995

cc:

Senator Joseph Biden
Senator Barbara Boxer
Senator Diane Feinstein
Senator Tom Harkin
Senator Barbara Mikulski
Congressman Berkley Bedell
Congresswoman Nancy Pelosi
Dr. Jan Buckner
Dr. Jay Greenblatt
Mr. Richard Jaffe
Dr. Wayne Jonas
Mr. Robert Lanman
Ms. Mary McCabe
Dr. Mark Malkin
Dr. Tony Murgo
Dr. Ralph Moss
Dr. David Parkinson
Dr. Edward Sondik
Dr. Mario Sznol
Dr. Dorothy Tisevich
Dr. Alan Trachtenberg
Mr. Frank Wiewel
Dr. Robert Wittes
——————————————————————

======================================
1995 (5/16/1995) – Burzynski to [15]
(2 pgs.)
1991 NCI review of 7 brain tumor cases
1994 – 5/2/1994 – MRI
1995 (4/3/1995) – Dr. Michael A. Friedman to Burzynski
1995 (4/20/1995) – Burzynski to
1995 (5/12/1995) – Dr. Michael A. Friedman to Burzynski
======================================

[16] – 1995 (4/20/1995) – Burzynski to Dr. Mario Sznol

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/
======================================
[16] – 1995 (4/20/1995) – Burzynski to Dr. Mario Sznol
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Mario Sznol, M.D., Department of Health and Human Services, National Institutes of Health

Dear Dr. Sznol,

Your letter of 4/3/1995

(copy attached)

does not provide adequate justification for the changes in the protocol for

“Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Advanced
Recurrent Astrocytomas.”

Let me make perfectly clear that, as the discoverer and developer of antineoplastons and the individual with nearly 20 years clinical experience using them, it is my professional opinion that the drugs will not produce substantial benefit in such advanced patients

The current protocol has had success only in patients who have tumors not exceeding 5 cm in diameter and who do not have multiple tumors or leptomeningeal or systemic metastases

As the Senior Investigator of NCI requested, patients should have Karnofsky Performance Status of not lower than 70%

(letter attached)

As I have repeatedly informed you, it is exactly because of the current protocol’s failure to benefit advanced patients that we developed new and more aggressive protocols for such advanced tumors, for example, provides antineoplaston A10 in doses 3 times greater than that specified in the protocol currently being used

In order to make such dosing possible, we are using a much higher concentration of A10 — 300mg/mL instead of 80mg/mL

The dosing schedule being used for such advanced tumors is also quite different

Instead of injections of each antineoplaston every 30 minutes, patients receive a much greater amount every 4 hours

Pg. 2

The acceptance of very advanced brain tumor patients to the current protocol would be highly unethical because there is no realistic chance they will have a meaningful response

The list attached to your letter of 4/3/1995 (enclosed), proves my observation that patients who had tumors substantially larger than 5 cm do not respond well under the current protocol

There were only 2 such patients, with the largest tumor diameter corresponding to 5.5 and. 6.5 cm

Both had less than 50% decrease in the size of their tumors

According to the existing protocol, patients should have more than a 50% decrease in tumor size to be classified as responders

Please bear in mind that the point of this trial is not to prove once again that this protocol does not work in patients with very large tumors, multifocal tumors, and low Karnofsky scores

We have already established this fact

Moreover, the informed consent form as currently written falsely implies that the discoverer of antineoplastons believes such advanced patients may benefit substantially from the current protocol

In fact, I have specifically informed you on several occasions that I do not believe advanced patients will obtain substantial benefit

Please be forewarned that you may face legal liability resulting from these unethical misrepresentations

We are anxiously awaiting the complete data on the 1st 5 patients as promised in your letter of 4/3/1995

Based on the limited information received from Theradex on the 1st 7 cases, we have reason to believe that the protocol has been violated in every case

5 cases have been accepted in violation of inclusion criteria

Due to interruptions in the treatment schedule and the time necessary to escalate the dosage, one of these patients received less than 3 weeks of full dose treatment

Such duration of treatment was not sufficient to show the effectiveness of the therapy

Finally, 2 additional patients were removed from the study and said to have progression of disease when in fact no progression was documented

One of these patients, #4369975, underwent tumor resection 3 weeks after discontinuation of the treatment with antineoplastons

Microscopic examination of the tumor specimen confirmed absence of viable tumor cells

It is clear that what was classified as tumor progression corresponded to extensive necrosis or tumor death

What I thought was especially inexcusable and unethical is that the 30 year old patient #196370, who clearly did not have progression of the tumor, was removed from the study against the criteria for removal listed in the protocol

This patients died a few months later
I strongly believe that if the patient had continued the treatment under the protocol, his life would have been saved

Attached to this letter, you will find a list of

Pg. 3

violations of the protocol

Based on these violations, it is clear that the current investigators are unable to conduct this study under the current protocol

I hereby request that:

1) The National Cancer Institute immediately terminate the current investigators and appoint mew investigators at different medical institutions acceptable to Burzynski Research Institute

2) Patient accrual must cease until such investigators and institutions are appointed

Until you appoint the new investigators, I will provide free treatment and medical care under my supervision as long as necessary to the patients currently being treated under the protocol

SRB/cf

Enclosure

cc:

Senator Joseph Biden
Senator Barbara Boxer
Senator Diane Feinstein
Senator Tom Harkin
Senator Barbara Mikulski
Congressman Berkly Bedell
Congresswoman Nancy Pelosi
Dr. Jan Buckner
Dr. Daniel Eskinazi
Dr. Michael Friedman
Dr. Jay Greenblatt
Mr. Richard Jaffe
Dr. Mark Malkin
Ms. Mary McCabe
Dr. Ralph Moss
Dr. David Parkinson
Ms. Dorothy Tisevich
Mr. Frank Wiewel
——————————————————————

======================================
1995 (4/20/1995) – Burzynski to [14]
1995 (4/20/1995) – Burzynski to [15] (3 pgs.)
1995 (4/3/1995) – Dr. Mario Sznol to Burzynski
======================================

[15] – 1995 (4/3/1995) – Dr. Mario Sznol to Burzynski

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/
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[15] – 1995 (4/3/1995) – Dr. Mario Sznol to Burzynski
——————————————————————
Department of Health and Human Services, Public Health Services, National Institutes of Health, National Cancer Institutes

Dear Dr. Burzynski,

Dr. Friedman asked me to respond to your letter of 3/29/1995 regarding the change we have been considering in eligibility criteria for the Memorial Sloan-Kettering and Mayo Clinic phase II studies of antineoplastons

At the investigator’s request, the amendments to modify the eligibility restrictions for size of tumor, number of tumors, and leptomeningeal spread, and to allow entry of patients with KPS of 60, have been approved

These amendments were initiated by the investigators when it became apparent that many good candidates for the study were being excluded because of what were perceived to be overly stringent and unnecessary eligibility restrictions

Approximately a year ago, we wrote to you asking for your concurrence to make similar changes to the protocol

(see enclosed letter)

We have documented that the revised eligibility criteria are consistent with those used in your very own protocols that employ identical or nearly identical treatment regimens

Furthermore, in a review of the 7 patients in the best case series presented to NCI, we have found that perhaps 4 of the 7 patients who apparently had tumor shrinkage would not have been eligible to enter the NCI phase II studies under the original stringent eligibility criteria

(see attached)

These types of patients will now be eligible for study using the revised eligibility criteria proposed by the investigators and recently approved by CTEP

Despite the difficulties in accrual, we are committed to completing the phase II evaluation of the antineoplastons

Our goals remain unchanged, that is, we wish to determine whether the drugs used in the similar manner as you recommend, and in the similar population of patients, will yield results consistent with those in the best case series

As noted above, our careful evaluation of the materials you have provided indicate that the amendments to the eligibility criteria do not deviate from the eligibility criteria and methods you have employed in your experience

We would appreciate the opportunity to review your data, alluded to in your letter, that support the contention that inclusion of theses patients requires a different treatment regimen or is unsafe

In the meantime, we will allow the amendments to stand, since all evidence you have provided to date indicates that these newly eligible patients may have a chance for benefit without undue risk of harm, and are appropriate candidates for evaluation of the drug

We will forward the data on the 1st 5 patients in a separate mailing as you requested

Pg. 2

However, you have asked that we suspend accrual while you review the data

There is no medical or regulatory reason to suspend accrual at this time

Suspending accrual will likely further damage the efforts the investigators have made to increase accrual to the trial

Mario Sznol, M.D.

cc:

Dottie Tisevich
Michael Friedman, M.D.
Mary McCabe
Office of Alternative Medicine

Pg. 3

Antineoplaston Cases

1. Histology partial lobe glioblastoma multiforme
Size 2.3 cm largest diameter
Response CR possible
prior Tx RT, surgery

2. Histology anaplastic astrocytoma stage IV grade 3
Size 3.0 tumor 3.5 tumor and edema
Response CR possible
prior Tx RT

3. Histology infiltrating glioma (astrocytoma or mixed astrocytoma / oligodendroglioma)
Size 4.4
Response good PR, possible CR
prior Tx RT and BUdR; Procarbazine, CCNU, VCR; B-Interferon; DFMO and MGBG

4. Histology well differentiated Stage IV astrocytoma, possible juvenile pilocytic astrocytoma
Size 5.5 X 3.3
Response 40-50% decrease of solid component
prior Tx vitamins and laetrile

5. Histology glioblastoma multiforme
Size 6.5 x 5.0
Response 39% decrease
prior Tx RT

6. Histology glioma consistent with anaplastic astrocytoma, differential: anaplastic astrocytoma or spindle cell variant of oligodendroglioma
Size 5.1 x 2.2
Response CR
prior Tx RT

7. Histology Infiltrating anaplastic astrocytoma
Size 4.0 (L) 4.8 (bifrontal)
Response good response – possible CR
prior Tx RT
——————————————————————

======================================
1995 (4/3/1995) – Dr. Michael A. Friedman to Burzynski [16]
1995 (4/3/1995) – Dr. Mario Sznol to Burzynski [21] (3 pgs.)
1995 (3/29/1995) – Burzynski to Dr. Michael A. Friedman
======================================

[14] – 1995 (3/29/1995) – Burzynski to Dr. Michael A. Friedman (2 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/
======================================
[14] – 1995 (3/29/1995) – Burzynski to Dr. Michael A. Friedman (2 pgs.)
——————————————————————
Michael A. Friedman, M.D., Associate Director,Cancer Therapy Evaluation Program, Division of Cancer Treatment, NCI, National Institutes of Health

Dear Dr. Friedman,

It has been brought to my attention that the protocol

“Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Advanced Recurrent Malignant Astrocytomas”

has been amended to accept patients with tumors measuring over 5 cm in diameter, multiple tumors, or with leptomeningeal or systemic metastases

Another change involves lowering of the Karnofsky Performance Status score to 60%

You assured me in your letter of 11/2/1993 that

“The dose and schedule will be modified exactly as you require”

and

“The eligibility criteria will be modified to accept only patients with Karnofsky Performance Status of 70% – 100%

I am outraged that without my knowledge Memorial Sloan-Kettering Cancer Center with NCI’s permission changed the protocol

Treatment of patients with tumors larger than 5 cm, with multiple tumors, and leptomeningeal spread or distant metastases will require a different protocol with a different schedule and different dosages

the use of the existing protocol for such very advanced brain tumor patients will only expose them to unnecessary risks without giving them substantial benefit

I hereby request that the amendments described above be cancelled immediately and the original protocol be used for the treatment as promised in your letter of 11/2/1993

We will be glad to propose a different protocol for patients with larger and multiple tumors and meningeal involvement

In addition, the procedure we agreed upon calls for a thorough review by us of the 1st 5 patients as soon as they are accrued

Your last annual report indicates

Pg. 2

that you had accrued that number of patients 6 months ago

As a result, the review of data is long overdue

Please send us the complete records of the 1st 5 patients so that we may review them as specified

Please do not accrue any more patients until this data has been sent and our review completed

SRB/cf

cc:

Dr. Jan Bruckner
Dr. Michael C. Christian
Dr. Jay Greenblatt
Dr. Mark Malkin
Ms. Mary McCabe
Dr. David Parkinson
Dr. Mario Sznol
Ms. Dorothy Tisevich
——————————————————————

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1993 (11/2/1993) – Dr. Michael A. Friedman to Burzynski
======================================

[12] – 1994 (4/19/1994) – Burzynski to Dr. Mario Sznol [2 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/
======================================
[12] – 1994 (4/19/1994) – Burzynski to Dr. Mario Sznol [2 Pgs.]
——————————————————————
Mario Sznol, M.D., Head, Biologics Evaluation Section, Investigational Drug Branch, CTEP, DCT, National Cancer Institute

Dear Dr. Sznol,

I am glad to learn from your letter of 3/23/1994 that some patients have already been enrolled in the NCI-sponsored trials of Antineoplastons and there is a strong interest of the NCI and the Investigators to broaden the study

While I think that, ultimately, Antineoplastons would prove useful in the treatment of more advanced cases of malignant brain tumors, I think that to expand the trials now through admission of such difficult cases is premature

The 1st stage of the studies which are currently in progress should be completed in order to have the most accurate preliminary evaluation of anticancer activity

I sincerely hope that the Investigators conducting the study will report good results in the treatment of at least some of the initial 15 patients involved in stage I

However, if the reverse is true, then it won’t make any sense to conduct trials in very advanced cases if less advanced cases do not respond

I would expect that there would be a significant difference in response between the patients admitted under current acceptance criteria and the expanded eligibility criteria proposed in your letter of 3/23/1994

Therefore, I think that such patients should be involved in a separate trial for large and multifocal tumors, and treated and evaluated according to a modified protocol

SRB/cf

cc:

David Parkinson, M.D.
Mike Friedman, M.D.
Dale Shoemaker, Ph.D.
Jay Greenblatt, Ph.D.
Dean Mouscher, BRI
Mary McCabe, R.N.
Samuel Broder, M.D.
Bruce Chabner, M.D.
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1994 (3/23/1994) – Dr. Mario Sznol to Burzynski
1994 (4/19/1994) – Burzynski to Dr. Mario Sznol [20] (2 pgs.)
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[11] – 1994 (3/23/1994) – Dr. Mario Sznol to Burzynski [2 pgs.]

This page is linked to:
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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
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https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[11] – 1994 (3/23/1994) – Dr. Mario Sznol to Burzynski [2 pgs.]
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Department of Health and Human Services, Public Health Services, National Institutes of Health, National Cancer Institutes

Dear Dr. Burzynski,

As you know, the NCI-sponsored trials of antineoplastons have been initiated and some patients have been enrolled

However, a great many more have sought access to the trial but have not been allowed to participate because of their inability to meet all the eligibility criteria

Because of this, there is strong interest on our part and that of the investigators to broaden the eligibility criteria

While we recognize the need for and value of clear eligibility criteria, we believe that the protocol now excludes some patients who would otherwise be good candidates for the trial

Specifically, we would propose the following changes in the eligibility criteria:

1. Change the allowable Karnofsky performance status from 70 to 60, as originally written in the protocol

2. Change the exclusion for size of tumor from greater than 5 cm to greater than 8 cm

3. Drop the exclusion for multifocal tumors or leptomeningeal spread

By keeping the performance status score at 60 as a requirement for entry, we believe that the protocol will still be safe for patients, and the drug will get a fair test for antitumor efficacy

We have noted that your protocols for adults (copies of which you have provided to CTEP) have similar eligibility criteria to those proposed above (ie, KPS of 60 required and no exclusion for size of tumor, multifocal tumor, or leptomeningeal spread)

We have also noted that some patients eligible for treatment on NCI-sponsored protocols appear to have been told by your staff that they could receive the antineoplastons at your institute

They have asked us the obvious question, that is, if you have enough evidence of efficacy to offer the antineoplastons as treatment to those patients, why is it that they would not be good candidates for a protocol attempting to determine and confirm the antitumor activity of the agent?

We would appreciate any help you might give us in responding to these inquiries

Pg. 2

Mario Sznol, M.D., Head, Biologics Evaluation Section, Investigational Drug Branch,Cancer Therapy Evaluation Program, Division of Cancer Treatment,
National Cancer Institute

cc:

David Parkinson, M.D.
Mike Friedman, M.D.
Dale Shoemaker, Ph.D.
Jay Greenblatt, Ph.D.
Dean Mouscher, BRI
Mary McCabe
Samuel Broder, M.D.
Bruce Chabner, M.D.
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1994 (3/23/1994) – Dr. Mario Sznol to Burzynski [20] (2 pgs.)
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