Stanislaw Rajmund Burzynski, Stanislaw R. Burzynski, Stanislaw Burzynski, Stan R. Burzynski, Stan Burzynski, S. R. BURZYNSKI, S. Burzynski, Arthur Burzynski, Hippocrates Hypocrite Hypocrites Critic Critics Critical HipoCritical
Tag Archives: “In which the latest movie about Stanislaw Burzynski’s “cancer cure” is reviewed…with Insolence”
—————————————————————— DJT – Didymus Judas Thomas
—————————————————————— BB – Bob Blaskiewicz
====================================== (0:12:00)
—————————————————————— DJT – 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
—————————————————————— (0:13:00)
—————————————————————— DJT – 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
——————————————————————
—————————————————————— DJT – 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
—————————————————————— 0:14:24
======================================
If it's true that #burzynski and his adman Merola have insinuated that parents are to blame for Amelia's death that's utterly disgusting.
====================================== DJT – 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 [4]
“I think” ====================================== 11/2/2012 – “Personally having pored over Burzynski’s publications” ======================================
DJT – 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
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 ?
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 [5]
—————————————————————— 0:25:07
—————————————————————— DJT – 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 [6] ====================================== “Temodar and Avastin both had proper, completed, and published phase II trials before approval” ======================================
====================================== Bob Blaskiewicz (@rjblaskiewicz) tweeted at 10:44am – 31 Jul 13:
@TomLemley1 @AceofSpadesHQ @mikespillane The FDA won’t approve his drug until he ever finishes and publishes a trial. clinicaltrials.gov/ct2/results?te…
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
——————————————————————
—————————————————————— 0:44:00
—————————————————————— DJT – 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 favorite oncologist didn’t comment about that in his movie review [7]
——————————————————————
—————————————————————— 1:11:04
—————————————————————— BB – “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”
—————————————————————— DJT
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
—————————————————————— BB – “No, that is tied together”
—————————————————————— 1:12:00
—————————————————————— BB – “But let me, we know that that the the, the central concern is Burzynski“ ======================================
This is so Hilarious
Bob, why don’t you give a detailed explanation of how my blog with all its different search functions, is more “disorganized” than yours, and how about an in-depth data-analysis of Gorski’s “Respectful Insolence” blog, listing the # of Burzynski articles versus other articles
Oh
By the way, if you have NOT yet figured it out, my entire blog is Burzynski related ====================================== DJT – 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
—————————————————————— BB – “Did he, did he leave them up ?”
“Did he leave them up ?”
—————————————————————— DJT – 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
—————————————————————— BB – “Right, um, do you think that he is required to answer you ?”
—————————————————————— DJT – 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 [8]
—————————————————————— BB – “Right”
—————————————————————— DJT – You know, I can tell his readers come on my blog because it shows that they come on my blog
——————————————————————
—————————————————————— 1:34:00
—————————————————————— BB – “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”
——————————————————————
—————————————————————— 1:39:00
—————————————————————— BB – “Uh, what’s next for you”
—————————————————————— DJT – 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
====================================== ====================================== 6/3/2013 – “[I]f I had screwed up, I would have admitted 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
——————————————————————
—————————————————————— 1:56:02
—————————————————————— DJT – Well, I’m sure, I’m sure Gorskiwould have a comment about that, as he’s commented previously about how he thinks uh Burzynski should publish
—————————————————————— BB – “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
—————————————————————— BB – “Um, yea, it doesn’t matter now whether or not Burz, whether or not Gorski agrees with how Burzynski publishes” ======================================
This is Laughable
Nowhere have I seen any indication from Gorski of a positive nature towards Burzynski [9] ====================================== DJT – Like I said before
Like I said before on my blog, you know, even if Burzynski publishes his phase 2 information, Gorski can just jump up and down and say, “Well, that just shows evidence of efficacy, you know, it’s not phase 3, so it doesn’t really prove it”
—————————————————————— 1:58:04
—————————————————————— DJT – So then he can go on, you know, for however many years he wants to
—————————————————————— BB – “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”
—————————————————————— DJT – Well,
—————————————————————— BB – “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 ?”
—————————————————————— DJT – 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
—————————————————————— DJT – 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
——————————————————————
—————————————————————— DJT – 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
—————————————————————— BB – “Except for a ph, completed phase 3 clinical trial”
——————————————————————
(laughing)
DJT – I mean, I love Gorski, but he comes up with these stupid excuses like, “Well, Burzynski is not an oncologist”
—————————————————————— 2:01:00
—————————————————————— DJT – 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
——————————————————————
Uh, Guy Chapman, “It’s a blog, not a peer-reviewed publication”
—————————————————————— BB – “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” ====================================== PROVE IT [10] ====================================== 2:03:03
—————————————————————— DJT – I mean, Gorski doesn’t want to deal with the issues
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
—————————————————————— DJT – I mean, Gorski will just
—————————————————————— BB – “Yeah, but they”
—————————————————————— DJT – post a lot of stuff without backing it up
——————————————————————
—————————————————————— 2:16:09
—————————————————————— DJT – 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
—————————————————————— BB – “Even if it’s true or false you, honestly though”
—————————————————————— DJT – We know it’s false
—————————————————————— BB – “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”
——————————————————————
—————————————————————— 2:18:00
—————————————————————— DJT – You know, I don’t see why Gorski is afraid of debating issues
—————————————————————— BB – “I don’t think he is””
—————————————————————— DJT – on the Internet, on his blog
—————————————————————— BB – “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
—————————————————————— BB – “I mean”
—————————————————————— DJT – 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
====================================== [0] – “Our only goal is to promote high standards of science in medicine”
====================================== [1] – 12/12/2012 – “Burzynski lumps all responses together in an oncologically meaningless way”
====================================== [2] – .3/14/2013
—————————————————————— “Temodar and Avastin both had proper, completed, and published phase II trials before approval”
====================================== [3] – .3/30/2013
——————————————————————
“[I]f I had screwed up, I would have admitted it”
====================================== The LIE
====================================== [2] – 6/4/2013 – Gorski LIED:
” … Burzynski never explains which genes are targeted by antineoplastons … “
—————————————————————— [3] – 8/7/2013 – I pointed out to Gorski the majority of Burzynski’s publications which explain “which genes are targeted by antineoplastons … “, although there are even more
—————————————————————— [4] – DISCLAIMER: “Because he is still a working academic surgeon and researcher (and hopes to remain so until he retires, which means—hopefully–for another 20 years or possibly even more), Dr. Gorski must emphasize that the opinions expressed in his posts on SBM are his and his alone … “
Gorski might incorrectly assume that his DISCLAIMER is going to allow him to hide like a snake in the grass, but it’s NOT
I have yet to see his admission that he “screwed up”, even though he has claimed:
—————————————————————— [5] – “Our only goal is to promote high standards of science in medicine”
—————————————————————— [6] – 11/.2/2012 – “Personally, having pored over Burzynski’s publications … “
—————————————————————— [7] – 5/8/2013 – “I’ve searched Burzynski’s publications … “
—————————————————————— [8] – 5/31/2013 – “Burzynski has a contingent of defenders who have targeted skeptics like me for special abuse, up to and including harassing me at work by calling my university to complain about my online verbiage critical of Burzynski and implying that I am somehow doing something wrong”
“(My university quickly realized that I was not.)”
—————————————————————— [9] – 6/5/2013 – “ … I do know cancer science”
—————————————————————— [10] – 6/7/2013 – “Unlike Mr. Merola, I am indeed very concerned with getting my facts correct”
====================================== An Ethical Conundrum
======================================
To me, the message the institutions that Gorski is affiliated with are sending a message that it’s okay to LIE
and, we hire LIARS
And that’s the position I’m taking until Gorski puts on some Big Boy pants and takes accountability for his actions
[1] – 8/27/2013 – Usually I do NOT read the Comments on Dr. David H. “Orac” Gorski’s National Geographic scienceblogs . com/Insolence, but I was researching a comment I remembered seeing, and came upon this hilarious example of one of Orac’s “Oracolytes” proving that he could do horrific research, just like his “god”
—————————————————————— [2] – #80 – Narad – August 31, 2013
For years, Gorski has been able to comment on Burzynski’s “personalized gene targeted therapy” with impunity
It’s about time he received some personal attention, leading to heapin’ helpings of not-so-Respectful Insolence
All of the below articles by Gorski were tagged as having to do with:
personalized gene targeted cancer therapy, or mention it
—————————————————————— http://scienceblogs.com/insolence/tag/personalized-gene-targeted-cancer-therapy/
—————————————————————— I AM ADDING TO THIS AS I GO ALONG
====================================== [1] – 6/5/2013 – ” … in January the Burzynski Clinic removed all references to antineoplaston therapy on its website … “
—————————————————————— [2] – 8/4/2013 – I proved Gorski wrong since Burzynski’s scientific publications regarding antineoplaston therapy are on the Burzynski website
====================================== [1] – 6/5/2013 – “Three years should be plenty of time to line up clinical sites for a phase III trial”
“Of course, given that after three years the clinical trial hasn’t been opened, more than likely no reputable institution wants to partner with the Burzynski Research Institute, and ResearchPoint collected its checks”
—————————————————————— [3] – 7/18/2013 – This statement by Gorski is disingenuous since 6/3/2013 he reviewed Burzynski: Cancer Is Serious Business, Part II where this issue was addressed, and he made NO COMMENT about it in his review
Gorski can distort, exaggerate, and even lie to the public
====================================== [1] – 6/5/2013 – “Another interesting tidbit in the SEC filing is Burzynski’s report of the results of several of his clinical trials”
“They aren’t really “results’ per se, in that the information presented really isn’t provided in a form that really allows other investigators to evaluate it and potentially replicate it”
“Basically it’s a big table listing Burzynski Research Institute clinical trials”
“Of course, I realize that this is an SEC filing, not a scientific paper in the peer-reviewed literature, but if Burzynski has all this data to produce this table it boggles the mind that, given at least a decade and a half since these trials began, he hasn’t been able to publish any meaningful data thus far”
“That he hasn’t been able to do so is also a big red flag”
—————————————————————— [5] – 8/21/2013 – That Gorski has NOT been able to prove that the 4 Burzynski publications I refer to are NOT “meaningful data” is a big red flag
====================================== [6] – 6/4/2013 – “It’s a theme that is repeated throughout the report but that ignores the astounding level of sheer deception that goes on at the Burzynski Clinic, the allegations of overfilling, and how Burzynski has abused the clinical trial process to keep treating patients with antineoplastons without actually having to do the science that any other doctor would be required to do to validate a new treatment”
—————————————————————— [7] – 6/23/2013 – This is the 1st time I’ve seen Gorski allege “overfilling,” and I sure have NOT seen him provide any proof of that or that Burzynski is NOT doing “the science that any other doctor would be required to do to validate a new treatment”
If anyone is being “deceptive,” it seems to be Gorski
====================================== [6] – 6/4/2013 – Dr. Elloise Garside, a research scientists, echoes a lot of the questions I have, such as how Burzynski never explains which genes are targeted by antineoplastons, … “
—————————————————————— [8] – 8/7/2013 – Gorski has NO response for where I list where Burzynski “explains which genes are targeted by antineoplastons”
====================================== [6] – 6/4/2013 – ” … what the preclinical evidence supporting their efficacy are … “
—————————————————————— [9] – 3/16/2013 – Gorski does NOT mention where he’s reviewed “the preclinical evidence supporting their efficacy”
====================================== [6] – 6/4/2013 – ” … or what the scientific rationale is to expect that they might have antitumor activity”
—————————————————————— [10] – 8/8/2013 – Gorski reviewed “Burzynski: Cancer Is Serious Business” (Part I), but acts as if Dvorit D. Samid was NOT mentioned, and that he is NOT aware that the BurzynskiMovie website contains supporting documentation
I can’t let such statements go unchallenged
It means NadaZeroZip
====================================== [6] – 6/4/2013 – “In science, all that matters is what you publish, and Burzynski hasn’t published anything other than case reports, tiny case series, and unconvincing studies, mostly (at least over the last decade or so) in crappy journals not even indexed on PubMed”
—————————————————————— [5] – 8/21/2013 – I remain unimpressed that Gorski has NOT written a review of Burzynski’s 2003-2010 phase II clinical trial preliminary reports
====================================== [6] – 6/4/2013 – “Without a doubt, the most effective part of the story is the segment in which Dr. Jeanine Graf of the Texas Children’s Hospital is introduced”
“Dr. Graf is the director of the pediatric intensive care unit there and has taken care of lots of Burzynski patients, as her hospital is “just down the road” from the Burzynski Clinic and these unfortunate children are brought to her hospital when they decompensate”
“Indeed, coupled with this segment is an interlude where Luna Petagine’s mother complains that the staff there know and recognize Burzynski patients (and, she notes, hate the Burzynski Clinic)”
“Particularly damning is how Ms. Petagine said that the Texas Children’s Hospital Staff “were always cleaning up Burzynski’s messes.””
“Luna was brought to the Texas Children’s Hospital during her time in Houston, and the staff there recognized right away that she was a Burzynski patient because they had seen so many similar patients suffering the same complications before”
“It was also clear how much contempt the staff there had for the Burzynski Clinic”
“If there’s one thing Panorama did right in this report, it’s showing how seeing so many already dying children show up in our ICU because of hypernatremia due to antineoplaston therapy will do that”
“Perhaps the most devastating part of this segment was seeing Dr. Graf stating, point blank, that she’s never seen a Burzynski patient survive”
“True, she does point out that patients don’t come to her until they are in extremis, but the fact remains that she’s never seen any of them live”
—————————————————————— [11] – 4/24/2013 – What is so ridiculous about this is that Richard Bilton wanted numbers from Burzynski, but then when it came to this part of the documentary, he somehow forgets how to ask how many patients this applies to, and Gorski compounds this by trying to blame hypernatremia on antineoplaston therapy, but he refuses to explain how it is that in this Division of Internal Medicine / Department of General Internal Medicine, University of Texas, MD Anderson Cancer Center, Houston, TX, USA, cancer study, over a 3 month period in 2006 re 3,446 patients, most of the HYPERNATREMIA (90 %) was acquired during hospital stay, and these patients were NOT on antineoplaston therapy
Arrogance, dismissiveness, and condescension make him his own worst enemy
====================================== [6] – 6/4/2013 – “Burzynski also pulls out the old trope that, if the FDA has been letting him use antineoplastons for 20 years in clinical trials if they weren’t safe and potentially effective, that the FDA wouldn’t let him “sell hope without evidence.””
“(Those of us following Burzynski for a while know, unfortunately, that that isn’t necessarily true.)”
—————————————————————— [12] – 4/25/2013 – “The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective” advises:
“[T]he emphasis in Phase 2 is on EFFECTIVENESS”
“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2″
The FDA has approved Burzynski’s phase 3 clinical trials, which means that antineoplastons have shown evidence of effectiveness, whether Gorski likes it or NOT
====================================== [6] – 6/4/2013 – ” … he goes on to repeat the same refrain he’s been repeating for the last decade or so about how he’s on the verge of publishing all the results that will convince everyone”
“One notes that we’re still waiting”
—————————————————————— [13] – 7/25/2013 – Gorski provides NO citation to support his statement, and, he did a review of “Burzynski: Cancer Is Serious Business, Part II,” but conveniently does NOT comment in his review about the refusal e-mail shown in the film, and its suspect content
====================================== [6] – 6/4/2013 – “Burzynski needs to publish, but I highly doubt that he will, at least not in a form that is informative to real oncologists”
—————————————————————— [5] – 8/21/2013 – I’m waiting for Gorski to prove that the 4 Burzynski publications I refer to are “NOT in a form that is informative to real oncologists”
Why don’t YOU cite a phase 2 clinical trial final publication that has substantially more data fields than the 4 publications I mention ?
====================================== [4] – 6/3/2013 – “I refer you to the link for my discussion of many of the problems with the movie”
“Here I will concentrate mainly on issues that I haven’t discussed before, because actually seeing Burzynski II was a revelation”
“(Yes, I put that sentence there on purpose, Eric Merola; quote mine it if you have the cojones)”
—————————————————————— [3] – 7/18/2013 – Gorski, don’t wait for Eric Merola to quote you
I’ve quoted you
Now let’s see if YOU have the cajones
MY review of your “review” should be a revelation to YOU
====================================== [4] – 6/3/2013 – “I’m referring to Chris Onuekwusi, a man who was diagnosed with stage I colon cancer”
“Instead of undergoing straightforward surgery that we know to have a high probability of success (which, I’ll also point out, can be done these days through minimally invasive laparoscopic techniques), Onuekwusi balked, as described in more detail than in the movie in this article on the Burzynski Patient Group website”
“He had even gone for a second opinion at one of the leading cancer centers in the world, the University of Texas M.D. Anderson Cancer Center, where the surgeon told him the same thing”
“He needed surgery first”
—————————————————————— [3] – 7/18/2013 – Mr. Onuekwusi did NOT want surgery
====================================== [4] – 6/3/2013 – “So what did Burzynski recommend instead of surgery?”
“He recommended a cocktail of three drugs given off-label:”
“Zolinza, Xeloda, and Avastin”
“Zolinza is vorinostat, a histone deacetylase inhibitor; Xeloda is capecitabine, which is a prodrug for 5-fluorouracil (5-FU), a pyrimidine analog that inhibits the enzyme thymidylate synthetase and thereby inhibits DNA synthesis to toxic effect in rapidly dividing cells; and Avastin is bevacizumab, a humanized monoclonal antibody directed against vascular endothelial growth factor-A (VEGF-A)”
“As I described in a previous post about Burzynski’s “personalized, gene-targeted cancer therapy,” apparently Burzynski sent Onuekwusi’s tumor to Caris for testing”
====================================== [14] – 3/2010 – Burzynski advised that a blood or pathology specimen can be used for testing, and that results from a blood test can be obtained within 2 days, and used and refined by a pathology specimen within 2 to 3 weeks
====================================== [4] – 6/3/2013 – “Caris generated a report, as it always does, and Burzynski came up with a witches’ brew of new expensive targeted agents, all said to be “off-label.””
====================================== [15] – 5/17/2011 – Well, not exactly
Burzynski made it clear in part 2 of this interview that there is constant searches of medical literature (phase 2 and phase 3 publications) to research the medications to be used based on the cancer genes involved, and that they have worked on software so oncologists can use it to choose the best medications instead of reinventing the wheel and having to review the medical literature again
So, he does NOT come up with a “witches’ brew”
====================================== [4] – 6/3/2013 – “One of these drugs is just an old chemotherapy drug in a new form”
“Xeloda is, in essence, 5-FU, a chemotherapeutic drug that has been used to treat colorectal cancer, both as adjuvant chemotherapy and first-line therapy for metastatic disease, for over 40 years”
“There’s nothing really “targeted” about the drug except that it inhibits an enzyme, the way that many drugs do and have been known to do for decades”
“The advantage of Xeloda is that it can be administered orally, which is a good thing”
====================================== [16] – What Gorski fails to mention is that Xeloda (Capecitabine) is approved to be used alone or with other drugs to treat:
Stage III colon cancer in patients who have had surgery to remove cancer
May also apply to unapproved uses being studied
—————————————————————— [17] – fluoropyrimidine carbamate belonging to class of antineoplastic agents called antimetabolites
As prodrug, capecitabine is selectively activated by tumor cells to cytotoxic moiety, 5-fluorouracil (5-FU); subsequently, 5-FU is metabolized to 2 active metabolites, 5-fluoro-2-deoxyuridine monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP) by tumor cells and normal cells
FdUMP inhibits DNA synthesis and cell division by reducing normal thymidine production, while FUTP inhibits RNA and protein synthesis by competing with uridine triphosphate for incorporation into RNA strand
====================================== [4] – 6/3/2013 – “Similarly, Avastin, although relatively new, is also commonly used for colorectal cancer, albeit usually for metastatic disease and not as adjuvant chemotherapy”
====================================== [18] – What Gorski fails to mention is that Avastin (Bevacizumab) is approved to be used alone or with other drugs to treat:
Colorectal cancer that has metastasized (spread to other parts of body)
May also apply to unapproved uses being studied
—————————————————————— [19] – A recombinant humanized monoclonal antibody directed against the vascular endothelial growth factor (VEGF), a pro-angiogenic cytokine
Bevacizumab binds to VEGF and inhibits VEGF receptor binding, thereby preventing the growth and maintenance of tumor blood vessels
====================================== [4] – 6/3/2013 – “That leaves Zolinza, which is an HDAC inhibitor used to treat cutaneous T cell lymphoma”
====================================== [20] – What Gorski fails to mention is that Zolinza (Vorinostat) is a histone deacetylase inhibitor, approved for treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in patients with progressive, persistent, or recurrent disease
May also apply to unapproved uses being studied
—————————————————————— [21] – A synthetic hydroxamic acid derivative with antineoplastic activity
Vorinostat, a 2nd generation polar-planar compound, binds to catalytic domain of histone deacetylases (HDACs)
Allows hydroxamic moiety to chelate zinc ion located in catalytic pockets of HDAC, thereby inhibiting deacetylation and leading to accumulation of both hyperacetylated histones and transcription factors
Hyperacetylation of histone proteins results in upregulation of cyclin-dependant kinase p21, followed by G1 arrest
Hyperacetylation of non-histone proteins such as tumor suppressor p53, alpha tubulin, and heat-shock protein 90 produces additional anti-proliferative effects
Agent induces apoptosis and sensitizes tumor cells to cell death processes
Vorinostat crosses blood-brain barrier
====================================== [4] – 6/3/2013 – “One wonders if Burzynski included a second HDAC inhibitor, his second favorite drug after antineoplastons, sodium phenylbutyrate”
====================================== [22] – 11/19/2012 – Gorski, if you had done “exhaustive research” on Burzynski and “Gene-Targeted Cancer Therapy,” you would have viewed this @youtube video:
Texas Med. Bd. v. Dr. Burzynski – Gene-Targeted Cancer Therapy – Case Dismissed 11/19/2012
BurzynskiMovie
and you would have heard Mr. Onuekwusi say at 3:45, that he took phenylbutyrate (PB)
====================================== [4] – 6/3/2013 – “So, by Merola’s own description, what Burzynski did was to administer a toxic form of treatment that was probably not needed (chemotherapy) using drugs that were not approved for that indication, and apparently didn’t insist that the patient needed surgery”
====================================== [23] – 12/13/2012 – Gorski publishes so much garbage that he may have forgotten his article where he posted:
“Then, there is also this video, produced by the Burzynski clinic itself:”
“At around the three minute mark, the announcer states:”
“We combine gene-targeting drugs and low dose chemo, if needed”
====================================== [4] – 6/3/2013 – “Now, it’s possible that the combination of drugs did eliminate the tumor”
====================================== Gorski, do you think that’s because as mentioned in [15], above, Burzynski would review publications like this ?
[24] – 8/23/2011 – A randomized, phase III trial of capecitabine [Xeloda] plus bevacizumab [Avastin] (Cape-Bev) versus capecitabine plus irinotecan plus bevacizumab (CAPIRI-Bev) in first-line treatment of metastatic colorectal cancer: the AIO KRK 0110 trial/ML22011 trial [1st-line treatment of patients with unresectable metastatic colorectal cancer (mCRC)]
—————————————————————— [25] – 11/2/2010 – Vorinostat [Zolinza] synergises with capecitabine [Xeloda] through upregulation of thymidine phosphorylase
—————————————————————— [26] – 4/2012 – Phase I–II study of vorinostat [Zolinza] plus paclitaxel and bevacizumab [Avastin] in metastatic breast cancer: evidence for vorinostat-induced tubulin acetylation and Hsp90 inhibition in vivo
—————————————————————— [4] – 6/3/2013 – “In my opinion, Burzynski deserves to have his medical license taken away on the basis of how he treated Chris Onuekwusi alone, not even considering all the other dubious things he’s done”
====================================== [27] – 8/27/2013 – In my opinion, Gorski deserves to have his medical license taken away on the basis of how he has misinformed, disinformed, and lied about Burzynski, not even considering all the other dubious things he’s done
====================================== [4] – 6/3/2013 – “All I can say is that Merola and Burzynski must not have searched very hard, because I quickly found a few … “
“Truly, Merola’s “exhaustive” research skills need some upgrading”
“It took me two minutes to find those articles”
====================================== [22] – 11/19/2012 – All I can say is that Gorski must NOT have searched very hard, because I quickly found this @youtube video about Dr. Burzynski – Gene-Targeted Cancer Therapy, which includes a segment on Burzynski’s cancer gene testing at 2:45
Truly, Gorski’s “exhaustive” research skills need some upgrading, since nowhere does it indicate that Burzynski was involved with doing Merola’s research
It took me 2 minutes to find this out
Seeing is believing?
To me seeing is knowing just how intellectually dishonest David Gorski is
====================================== [4] – 6/3/2013 – Seeing The Skeptics
“Particularly seemingly damning are a series of Tweets flashed on the screen saying things like the Hope for Laura fund (the fund set up by Laura Hymas to pay for her treatment at the Burzynski Clinic) “appears to be just a money laundry for a lying quack fraud” and “when Laura dies #Burzynski will just move on to his next mark if she doesn’t run out of money first.””
“I think I know whose Tweets these were”
“In fact, I’m sure I know whose Tweets these were, and all I can say to that person is this:”
“Zip it”
“Stop it”
“Put a sock in it”
“In fact, if I’m correct about whose Tweets these are I think I have already done so on Twitter when I’ve seen this person getting too close to attacking cancer patients”
“Still, as utterly insensitive and “dickish” as those Tweets were, they do not represent the majority of skeptics, but rather a few jerks”
“However, we as skeptics need to remember that a few jerks perceived (or painted) as attacking cancer patients can do immeasurable damage to the cause of science-based medicine”
“So if you’re one of those skeptics making comments like that, knock it off”
“If I see you doing it again, next time I will call you out publicly”
====================================== [28] – 2/19/2013 – Like this ?
——————————————————————
Of course it's always possible that the money launderers are appearing as themselves in the #Burzynski advertisement.
——————————————————————
And this ?
——————————————————————
BurzynskiSaves (@BurzynskiSaves) tweeted at 7:42pm – 25 Dec 11:
“@RatbagsDotCom:They will be even more vulnerable when Laura dies and #Burzynski forgets her and moves on to the next mark” #unconscionable https://twitter.com/BurzynskiSaves/status/151115741888909312
—————————————————————— [29] – 8/1/2013 – And like you called this guy out ?
——————————————————————
David James (@StortSkeptic) tweeted at 7:08pm – 1 Aug 13:
The new Doctor Who will be Stanislaw #Burzynski. He manages to continually avoid getting cornered and he gets away with murder.
The new Doctor Who will be Stanislaw #Burzynski. He manages to continually avoid getting cornered and he gets away with murder.
====================================== [4] – 6/3/2013 – “Then, there was the kicker”
“Eric Merola and Laura Hymas’ fiancé Ben Hymas called me a liar”
“Ben Hymas is quite mistaken in saying about me,”
““He’s lying to them.””
“Moreover, if I had screwed up, I would have admitted it”
“Indeed, part of the reason I looked into this so closely was because I wondered if somehow Merola had actually found a mistake I had made”
“You know the saying about the proverbial blind squirrel occasionally managing to find a nut?”
“It’s possible, albeit unlikely, and in fact there was no mistake”
“There is nothing in deceptive to change my assessment of what happened in the case of or my opinion of Eric Merola”
====================================== [3] – 7/18/2013 – As I said before, Gorski’s research skills leave much to be desired
Gorski is a hack and is only funny by accident because he has no filters
If anything, having seen his “review” of Burzynski II, my opinion of Gorski has plummeted even further, something I had thought possible
Gorski, so you got lucky like a blind squirrel and found an error
However, this does NOT change the fact that you’ve been proven to be a liar
Do you want me to subtract one of your lies from the tally ?
====================================== [30] – 5/9/2013 – “On what basis is he “targeting” his therapy?”
“As I’ve recounted before, Burzynski usually sends off blood and tissue samples to Caris for testing”
“The Caris Target Now™ test, which since my discussion of Burzynski’s “personalized therapy” appears to have been renamed Caris Molecular Intelligence and is now available at more levels of service (although its reports look much the same to me), is nothing unique to the Burzynski Clinic”
“Anyone who is willing to pay for it can have it, and the report will be the same”
“In any event, there is as yet no convincing evidence that the Caris tests (or any of the other competing tests) result in better outcomes”
====================================== [31] – 5/28/2013 – A key pillar of Gorski’s position on Burzynski’s “personalized gene-targeted cancer therapy” is that he alleges that he is “someone relatively knowledgeable about the state of personalized cancer therapy”
I can’t help but wonder why it is that he did NOT know the above information
Maybe he isn’t as knowledgeable about personalized cancer therapy and targeted therapies as he claims
(Oh, wait. He isn’t!)
That’s why when he wrote his “review” on Sheila Herron, he did NOT even refer to Burzynski’s publication:
—————————————————————— [32] – 8/2011 – Successful Treatment of Recurrent Triple-Negative Breast Cancer with Combination of Targeted Therapies
When it comes to Gorski’s “story writing” pal Robert J. “Bob” Blaskiewicz, I might allow for some leeway since he’s only a “Perfessor,” but with Gorski on the other hand, I’m not nearly so benevolent
In my ever-Insolent opinion, he and his propagandist are cynically using patients like human shields to deflect criticism
Activities I cannot countenance
====================================== [33] – 4/19/2013 – “I now think I probably know with around 95% certainty) and Didymus Judas Thomas (whose identity I’m probably about 75% sure of … also obsessively read anything posted about Eric Merola or Stanislaw Burzynski on any social media”
====================================== [34] – 4/19/2013 – Gorski has had over 4 months to say who he thinks I supposedly am, and so far he’s been a failure
But then again, as could be expected, he was wrong about his 2nd theory as well
Finally, I believe that people like Gorski are hypocrites, feeling free to paint Burzynski to their heart’s content (from what I’ve read about Burzynski on blogs, Twitterarticles, and elsewhere, posted by biased, disingenuous, “holier than thou” Skeptics, in them Burzynski is all but portrayed as Satan Incarnate) but running like whipped puppies to the Coward section when either they or Gorski are criticized, no matter how civil, reasonable, or science-based that criticism is (and my blog is all of the above)
The reason is, of course, clear
Having no convincing science, no convincing medicine, and no convincing evidence to support their hero’s antineoplastons hackery or “personalized MUD-targeted therapy for dummies,” they resort to Twitter thuggery
Same as it ever was
One more thing:
If Gorski and his crew of sycophants, toadies, and lackeys are offended by my opinion, my characterization of them that I have based on analyses of claims and observation of the behavior of them and their propagandist, they should try something different to shut me up
I have just the thing, too
Publishing the results of some of the responses to my blog for the scientific community comes to mind first
If Gorski really has the goods, as he and “The Skeptics” claim, then he can best shut me up by bringing the science—solid, convincing science, that is
I’ve said it before many times, and I’ll say it again:
I can be convinced by strong truthful and factual evidence
I have yet to see anything resembling strong evidence from Gorski
At least, if he has such evidence he hasn’t published it yet, preferring to publish a mixture of whiny blog articles where he takes a swipe at Burzynski, tiny-mind series, unimpressive basic science, and the like in bottom-feeding blog articles, some of which aren’t even indexed in PubMed
Nor is a conspiracy of cowardice—excuse me, “The Skeptics”—the reason why trying to ignore criticism will boomerang on “The Skeptics”
It’s all because of their own behavior and willingness to distort, misinform, and slime Burzynski
====================================== [35] – 1/14/2013 – “As you might recall, antineoplastons are chemicals that Burzynski found in the urine of cancer patients and that (or so he claims)”
====================================== [36] – 2/19/2013 – Seriously, Gorski ?
Where did you come up with that ?
After comparing the blood of healthy people to the blood of people with cancer, Dr. Burzynski found that people with cancer have lower amounts of a certain group of chemicals
====================================== [35] – 1/14/2013 – “None of this would have been too bad if only he had actually bothered to do the proper science and clinical trials to demonstrate that antineoplastons (1) have significant anti-cancer activity and (2) have acceptable levels of toxicity”
====================================== [10] – 8/8/2013 – Here’s (1)
—————————————————————— [37] – 2/19/2013 – And (2)
====================================== [35] – 1/14/2013 – “Oh, sure, he has a bunch of clinical trials listed on ClinicalTrials.gov, but virtually all of them are listed as having “unknown” status, and it’s unclear whether most, if any, of them are actually accruing”
====================================== [38] – 5/21/2011 – Cancer Breakthrough: 50-60% Success Rate, Cures the Incurable
May 21, 2011
12 phase 2 clinical trials have been successfully completed under supervision of FDA, and now conducting 3 phase 3 clinical trials
Or I can cite from Burzynski’s Securities and Exchange Commission (SEC) filings re his phase 2 clinical trials like you did [1] – 6/5/2013
====================================== [35] – 1/14/2013 – “In any case, Merola named the sequel what he named it … along with a website full of a “sourced transcript” to be used by Burzynski minions and shills everywhere to attack any skeptic who dares to speak out”
====================================== [39] – Gorski, you should have used the “sourced transcript” so you didn’t end up embarrassing yourself as much as you have
Actually, no one who is an apologist for Dr. Gorski, a.k.a. “Orac,” who over years ago unleashed MUD-targeted therapy on unsuspecting cancer patients, much likes Burzynski
It’s not surprising
Basically, Gorski’s a hack
—————————————————————— [40] – Or, you can use this – Burzynski: The Movie — Illustrated Screenplay and Screencap Gallery (Nader Library):
====================================== [35] – 1/14/2013 – “Part of the reason that Eric Merola doesn’t like me, aside from the fact that I am willing to help publicize Bob Blaskiewicz’s present to Dr. Burzynski for his 70th birthday on January 23, is that I think that every so often I happen to run into stories about the bad science and unethical nature of Burzynski’s work, and I blog about it”
====================================== [41] – 3/26/2013 – Maybe Eric does NOT like you because part of that “present” was your “pal” saying:
“The Burzynski clinic is a place you go to die”
—————————————————————— [42] – 8/24/2013 – Gorski, where were you when these 374 children died of brain cancer in #ScienceBasedMedicine clinical trials ?
====================================== [35] – 1/14/2013 – “I also run into patient stories”
“Although I don’t cover them as systematically as Bob does, I like to think that what I lack in comprehensiveness of coverage I make up for with my in-depth knowledge of cancer science and treatment”
====================================== [43] – 8/31/2013 – Your “in-depth knowledge of cancer science and treatment” ?
You sure have NOT presented a very strong case for that
Is your “man-crush”, Robert J. “Bob” Blaskiewicz still adding false statements to his “stories” ?
====================================== [35] – 1/14/2013 – “There are a number of things about this documentary that one can learn if one is involved in caner care and knowledgeable about Stanislaw Burzynski”
“Indeed, he’s even taken credit for pioneering the concept of personalized cancer therapy based on genes and the concept that cancer is a genetic disease, claiming to have published a journal article about it 20 years ago, allegedly long before conventional scientists and oncologists even thought of it”
“The problem, of course, is that, as far as I can tell, he published no such paper and personalized therapy is a concept older than 20 years”
====================================== [44] – 7/26/2013 – Indeed, from my perspective Gorski’s an egomaniac, full of the arrogance of ignorance about things like Burzynski’s “personalized cancer therapy”, prone to contemptuously dismissing anyone who has the temerity to question the Great and Powerful “Orac” is god
Because I was able to find the publication with NO problem
“Orac’s” Oracolytes remind me of the “believer” who said:
“god said it, and I believe it, so that settles it”
Of course, “Orac” is Oz tends to clam up when questioned by people who are NOT likely to be sycophants, toadies, and lackeys
====================================== [35] – 1/14/2013 – “Given that these are all phase II studies, it’s hard to believe that the FDA would allow Burzynski to keep them open over 13 years, but apparently it has”
====================================== [45] – 7/26/2013 – Gorski, why don’t you ask the FDA?
3/29/1996 Then United States Food and Drug Administration Commissioner, David Kessler told the American people:
“The … FDA’s initiatives … will allow …the agency … to rely on smaller trials … fewer patients … if there is evidence … of partial response in clinical trials”
—————————————————————— [46] – 6/7/2013 – Then you could be like Blatherskitewicz and do this:
Bob Blaskiewicz (@rjblaskiewicz)
6/3/13, 3:49 PM
@FauxSkeptic @bbc5live I believe he said, “Put up or shut up, you little bitch.” Something like that.
rjblaskiewicz: @bbc5live “I believe he said
“Put up or shut up
you little bitch”
BB: why not check with the @US_FDA
#Burzynski
BBC Panorama
====================================== [35] – 1/14/2013 – “Finally, why doesn’t Burzynski offer Seán his “personalized gene-targeted cancer therapy.””
“It probably wouldn’t be that big a deal to get the blocks of tissue from Seán’s biopsy and have them analyzed”
“Yes, inquiring minds do want to know”
====================================== [35] – 1/14/2013 – Gorski, why don’t you cite the applicable phase 2 and / or phase 3 clinical trial publications of FDA approved drugs for “inoperable brainstem glioma” ?
And while your at it, is the “girl from England” referred to in your article, the same one that is referred to in Burzynski 2 ?
====================================== [47] – 1/7/2013 – “That’s why I’m joining P.Z. Myers in asking you to help make Stanislaw Burzynski pay cold hard cash to a worthy cause
====================================== [41] – 3/26/2013 – Yes Gorski, your “pal” E.Z. P.Z. who wrote:
“The Burzynski clinic is a place you go to die”
He has no shame
But at least ya’ll raised money for a worthy cause while at the same time bringing attention to yourself and what I consider to be your incredibly unethical behavior
====================================== [23] – 12/13/2012 – “In fact, from my perspective, it appears to me as though over the last few years Dr. Burzynski has pivoted”
“No longer are antineoplastons the center of attention at his clinic”
“Rather, these days, he appears to be selling something that he calls “personalized gene-targeted cancer therapy.””
====================================== [48] – 4/26/2013 – Gorski it’s great to see you’ve been paying attention
” … in 1997, his medical practice was expanded to include traditional cancer treatment options such as
chemotherapy,
gene targeted therapy,
immunotherapy and
hormonal therapy
in response to FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in the Company’s antineoplaston clinical trials”
====================================== [23] – 12/13/2012 – “Finally, around the 4:30 mark, we see Dr. Gregory Burzynski, Dr. Burzynski’s son, talking about genomic profiling of cancers and biomarkers in the blood and in circulating tumor cells. … plus a claim that surgery will no longer be necessary for surgery, what’s left over doesn’t sound too different from what quite a few “conventional” cancer researchers say about “personalized medicine.””
====================================== [23] – 12/13/2012 – Gorski, “surgery will no longer be necessary for surgery” ?
Is this “attention to detail”” related to:
“because of the positions I hold at an NCI-designated comprehensive cancer center” ?
====================================== [23] – 12/13/2012 – “Clearly, the producer went to great lengths to make Burzynski’s lab look like any other molecular and cell biology lab–even like my lab”
====================================== [23] – 12/13/2012 – Gorski, are you trying to suggest that the producer rented or bought equipment to produce this look ?
Do you know how ridiculous that sounds ?
====================================== [23] – 12/13/2012 – “When we do this we have a very good chance to have positive results in most patients”
“SS: How many respond?”
“SB: About 85 per cent for whom we have the proper gene signature; about 15 percent do not respond”
“In our responders many of them have tumors which disappear completely and in others the tumors remain small”
“The problem is finding the genetic signature because for many of these different genetic signatures we don’t have blood tests…yet”
“Note that at the time this book was published, Dr. Burzynski was claiming that he could identify who would benefit from specific targeted therapies simply from blood tests”
“If he could do this for real, Burzynski could easily publish in high impact journals like Clinical Cancer Research, the Journal of Clinical Oncology, or another high impact clinical cancer journal”
“Heck, a result like that could probably make it into general medical journals, such as the New England Journal of Medicine or The Lancet, which have an even higher impact factor”
“If he were able to demonstrate that his method of testing tumors and picking targeted therapy could result in a complete response rate anywhere near 85% for breast cancer, even more so”
“If, as he claims later in the chapter, Dr. Burzynski has patients with pancreatic cancer and advanced liver cancer whose tumors have disappeared within two months after he began treatment, the same would be true”
“If, as Burzynski claims, he achieves a 50% complete response rate in advanced brain tumors, again, the same would be true”
“He doesn’t submit his results to these journals”
“Why not?”
====================================== [3] – 7/18/2013 – Gorski, why would Burzynski want to publish in The Lancet when you saw the lame excuse they gave in Burzynski 2 for NOT publishing Burzynski’s results; which YOU have refused to address ?
Maybe you could find out if you visited the Burzynski Clinic
Oh, wait
You’ve said that people do NOT need to go to the Clinic to learn things
====================================== [23] – 12/13/2012 – “Gene-targeted cancer therapy is currently in its infancy and, except in rare situations outside of the existing currently validated biomarkers (such as HER2, ER, c-kit, and other genes for which targeted therapies exist) for the response of specific cancers, is not to be undertaken outside of the context of a clinical trial“
====================================== [23] – 12/13/2012 – Gorski, that’s all well and good for you to write, but you provide NO citation, reference, or link in support of your statement, and you’ve proven that what you post can NOT be trusted
Try again
====================================== [23] – 12/13/2012 – “Before discussing how the Burzynski Clinic does personalized cancer therapy, I think it’s worth looking at how real scientists do it right now”
====================================== [23] – 12/13/2012 – Gorski, what are you implying ?
That Burzynski is NOT a “real scientist” ?
Because you stated:
“From the description above, it sounded very much to me as though Dr. Burzynski is combining various targeted agents with metronomic chemotherapy“
“I know a thing or two about metronomic chemotherapy, because I was involved in a project whose end result was to be the testing of metronomic chemotherapy against cancer and because the concept is a spinoff of the work of one of my scientific heros, the late Judah Folkman”
“Whether this is what Dr. Burzynski is doing or not with the chemotherapy part of his approach, I don’t know for sure, but it sure sounds like it“
====================================== [23] – 12/13/2012 – “Now let’s take a look at how the Burzynski Clinic does it, at least as far as I can figure out from my various sources and from Ms. Trimble”
“In response to my query about personalized gene-targeted therapy offered by the Burzynski Clinic, Ms. Trimble stated that a gene expression analysis is performed, as well as mutational analysis, FISH, immunohistochemistry for selected genes and that a blood test is also performed to measure the “concentration of proteins which are products of most important oncogenes.””
“In addition, drugs are supposedly selected based on the patient’s clinical information, standard of care, FDA indication, data from phase II and III clinical trials“
====================================== [4] – 6/3/2013 – Gee Gorski
In your 6/3/2013 article you act as if you did NOT know this
====================================== [23] – 12/13/2012 – “To support this claim, Ms. Trimble also sent me two papers from the Burzynski Clinic, both of which appeared in a journal I had never heard of before, the Journal of Cancer Therapy, which is clearly not indexed on PubMed because these papers never showed up when I searched PubMed for Burzynski”
“One described Burzynski’s approach for triple negative breast cancer (TNBC)”
====================================== [32] – 8/2011 – Gorski, why am I NOT surprised that you’re able to refer to this TNBC publication 12/13/2012, but when reviewing Sheila Herron’s TNBC case 5/28/2013, you completely ignored this publication, even though it specifically states:
“Here we report the successful treatment of metastatic TNBC with combination targeted therapy, and we discuss MDT for a group of 16 women including this patient, whose treatment was based on the same principle” (Pgs. 372-373)
How do you NOT provide a link to a previous article you wrote on the same subject, like you normally do ?
====================================== [23] – 12/13/2012 – “It turns out that perhaps the best description of what “personalized” treatment means in Dr. Burzynski’s hands comes from the Texas Medical Board’s complaint against him, which can be found in over at the Ministry of Truth or at Casewatch”
“This complaint is based on the cases of two patients”
“First, here’s Patient A, who is described in the complaint thusly:”
“1. Patient A:”
“a. In approximately May of 2008, Patient A presented to Respondent with breast cancer that had metastasized to her brain, lung, and liver”
“b. Respondent prescribed a combination of five immunotherapy agents – phenylbutyrate, erlotinib, dasatinib, vorinostat, and sorafenib-which are not approved by the Food and Drug Administration (“FDA”) for the treatment of breast cancer, and which do not meet the FDA’s regulations for the use of off-label drugs in breast cancer therapy”
“c. In combination with the five immunotherapy agents, Patient A was prescribed capecitabine, a chemotherapy agent”
“This is what’s known as “throwing everything but the kitchen sink” at the tumor without any thought of interactions, as most of these agents have no proven role in the treatment of breast cancer”
“For example, erlotinib (brand name: Tarceva) is used to treat pancreatic cancer and non-small cell lung cancer”
“It works by inhibiting the tyrosine kinase of the epidermal growth factor receptor (EGFR) and is not FDA-approved for breast cancer”
“However, it’s not unreasonable to think that it could work in breast cancer, as EGFR is believed to be important in some breast cancers, which is why this is an area of active research”
“Dasatinib (trade name: Sprycel) is also a kinase inhibitor”
“It inhibits the Src family tyrosine kinase”
“Vorinostat is a histone deacetylase inhibitor approved for use against cutaneous T-cell lymphoma”
“Finally, Sorafenib is another tyrosine kinase inhibitor that inhibits the tyrosine kinases of different receptors, as well as raf kinases”
“The big problem with this sort of approach is that the more drugs you add, no matter how “targeted” they are, the more chance for interactions that increase toxicity, and throwing all these kinase inhibitors together in a cocktail with chemotherapy is a recipe for disaster, particularly because such cocktails haven’t been tested in proper phase I clinical trials to evaluate toxicity”
====================================== Gorski, you make it sound like you reviewed the medical literature and found NO phase I clinical trials were conducted, or NO combinations of some of these drugs were tested
But you do NOT reveal your research
I’m guessing you reviewed these pre 5/2008 publications, right ?
—————————————————————— [49] – 4/20/2007 – Phase III study:erlotinib in combination with cisplatin and gemcitabine in advanced non-small-cell lung cancer
—————————————————————— [50] – 5/2007 – randomized phase II study: sorafenib/erlotinib – advanced non-small-cell lung cancer
—————————————————————— [51] – 4/20/2006 – Phase II study: capecitabine and erlotinib
—————————————————————— [52] – 1/2008 – Phase II Clinical Trial: Sorafenib
—————————————————————— [53] – 4/2007 – Antitumor Activity: Sorafenib – 4 Phase I Trials: Advanced Refractory Solid Tumors
—————————————————————— [54] – 6/20/2007 – phase I study: vorinostat (VOR) in combination with capecitabine (CAP) – advanced solid tumors
====================================== [23] – 12/13/2012 – “In any case, as we have seen, Dr. Burzynski does give chemotherapy”
“Lots of chemotherapy”
====================================== [23] – 12/13/2012 – Gorski, what was the date of the video you quoted above, about low-dose chemotherapy ?
====================================== [23] – 12/13/2012 – “Instead, skirting the line between science and pseudoscience, Dr. Burzynski gives every appearance of recklessly throwing together untested combinations of targeted agents willy-nilly to see if any of them stick but without having a systematic plan to determine when or if he has successfully matched therapy to genetic abnormality”
====================================== [15] – 5/17/2011 – That sure explains away the review of the medical literature (phase 2 and 3 clinical trials)
NOT
====================================== [55] – 12/12/2012 – “Note: Orac is away In the meantime, he is rerunning some of his favorite posts”
“Given that the blog seems to have been infiltrated with Burzynski trolls again now seems a perfect time to rerun a post of Orac’s from about a year ago”
====================================== [55] – 12/12/2012 – “Orac”, who’s the idiot who posted that “trolls” had taken over the blog, and who were these “alleged”“trolls” ?
Inquiring minds want to know
====================================== [55] – 12/12/2012 – “No one would ever confuse my reviews with those of Roger Ebert (mine tend to be a lot longer, for one thing, and concentrate on science much more than moviemaking), but I do sometimes subject myself to these movies when I can find a way to watch them online that doesn’t cost me any money”
====================================== [55] – 12/12/2012 – Gorski
“Concentrate on science” ?
really ?
Really ??
REALLY ???
Did you actually count how many characters and / or words you devoted to criticism instead of “science” ?
====================================== [55] – 12/12/2012 – “In the process, I might even look into a couple of Burzynski’s studies that I’ve read and found to be–well–lacking, to put it kindly”
====================================== [2] – 8/4/2013 – Gorski, why don’t you “look into” Burzynski’s 2003-2010 preliminary phase 2 clinical trial reports, and write a “review” ?
====================================== [55] – 12/12/2012 – “One part of the movie that truly insults the intelligence of anyone with a modicum of knowledge about drug therapy occurs near the beginning of the movie”
“It’s a part that, as a cancer surgeon who is interested in targeted therapies for breast cancer, I found particularly idiotic”
“First, there is a screen with this caption:”
“Antineoplastons target the specific genes that allow cancer to grow and flourish”
“A little later we see:”
“There are currently over 25 FDA-approved gene-targeted cancer drugs on the market today”
“Many of them can only target single genes”
“All of which is true but irrelevant if Burzynski is trying to sell antineoplastons as targeted therapy”
“Now here’s the kicker:”
“Antineoplastons work on close to one hundred different genes”
“You know what you call a drug that works on “close to 100 genes”?”
“I don’t know either, but you don’t call it a “targeted” therapy unless all those genes are genes affected by the single target being inhibited; i.e., are downstream targets of the gene targeted by antineoplastons”
====================================== [5] – 8/21/2013 – Gorski, how do you NOT know “the single target being inhibited … are downstream targets of the gene targeted by antineoplastons”, when you did NOT even know which of Burzynski’s publications discussed which genes are “targeted by antineoplastons” ?
====================================== [56] – 12/5/2012 – “In reality, oncologists shun Burzynski—and rightly so, given that he has yet to publish anything resembling a convincing result suggesting the efficacy of his antineoplastons against cancer”
“It’s painfully obvious from this paragraph that Burzynski doesn’t know academic oncologists”
“The reason oncologists don’t respect Burzynski is because of how he hasn’t show that his treatments work better than conventional treatments—or even that they work at all—and because of the way he abuses patients by charging them huge sums of money to participate in a clinical trial”
“Those are the reasons legitimate oncologists, at least those familiar with Burzynski, look askance at him”
“How could they do otherwise?”
“The ones who don’t take him seriously are the ones who know him best”
====================================== [57] – 4/24/2013 – Gorski, that certainly explains why this 2011 cancer study that references Burzynski:
Phase II trial of tipifarnib and radiation in children with newly diagnosed diffuse intrinsic pontine gliomas
University of California—San Francisco
Children’s Hospital Boston, Massachusetts
St Jude Children’s Research Hospital, Memphis, Tennessee
Seattle Children’s Hospital, Seattle, Washington
Children’s Hospital of Philadelphia, Pennsylvania
Children’s Hospital of Pittsburgh, Pennsylvania
Children’s National Medical Center, Washington, DC
Cincinnati Children’s Hospital Medical Center, Ohio
======================================
British Journal of Cancer (2010) 103, 1680–1691. doi:10.1038/sj.bjc.6605969
Published online 2 November 2010 http://www.nature.com/bjc/journal/v103/n11/full/6605969a.html
Experimental Pharmacology Unit, Department of Research, Istituto Nazionale Tumori, National Cancer Institute Fondazione G, Via.M Semmola, Pascale, Napoli, Italy
====================================== [26] – 4/2012
Phase I–II study of vorinostat plus paclitaxel and bevacizumab in metastatic breast cancer: evidence for vorinostat-induced tubulin acetylation and Hsp90 inhibition in vivo http://www.ncbi.nlm.nih.gov/pubmed/22200869/
Breast Cancer Res Treat. 2012 Apr;132(3):1063-72. doi: 10.1007/s10549-011-1928-x. Epub 2011 Dec 27 http://www.ncbi.nlm.nih.gov/m/pubmed/22200869/
Breast Cancer Res Treat. Author manuscript; available in PMC 2013 April.1 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3486521/
Published in final edited form as:
Breast Cancer Res Treat. 2012 April; 132(3): 1063–1072
I’ve made no secret of my opinion of a certain cancer “research” doctor named David H. Gorski, MD, PhD, of Wayne State University School of Medicine and Barbara Ann Karmanos Cancer Center / Institute, Detroit, Michigan fame
After a couple of winks I changed my characterization to say that it would have made Penn and Teller vomit in revulsion at its sheer incompetence
Be that as it may, I view Gorski as highly unethical and pseudononsense, an incompetent purveyor of “personalized MUD-targeted medicine for dummies,” and someone who might at one time have been on to something but, like all hacks, just couldn’t let go when it became clear that his personalized MUD-targeted Skeptic therapy was far more toxic than advertised and way less efficacious, if it’s even efficacious at all, which is highly doubtful.
Gorski claimed:
“[I]f I had screwed up, I would have admitted it”
Data talks
BS walks
And there’s no doubt that Gorski, too, is pure BS
In fact, I think I’m being too kind
I have yet to see his admission that he lied when he posted:
What science based medicine publication(s) does Gorski cite in support of his “theory”?
NONE !!!
What do the science based medicine publications indicate?
====================================== [1] 4/1/1992 PHENYLACETATE-novel NONTOXIC inducer of tumor cell differentiation
—————————————————————— Sodium PHENYLACETATE found to affect growth and differentiation of tumor cells in vitro at concentrations achieved in humans WITH NO SIGNIFICANT ADVERSE EFFECTS
—————————————————————— PHENYLACETATE is effective in inducing tumor cell maturation and FREE OF CYTOTOXIC AND CARCINOGENIC EFFECTS, a combination that warrants attention to potential use in cancer intervention
—————————————————————— Sodium PHENYLACETATE is investigational new drug approved for human use by U.S. Food and Drug Administration
—————————————————————— DRUG ALREADY ESTABLISHED AS SAFE AND EFFECTIVE … we propose use may be extended to cancer preventation and therapy
====================================== [2] 8/20/1992 Difficulties may be overcome through exploitation of recent discovery of sodium PHENYLACETATE as NONTOXIC inducer of differentiation …
—————————————————————— (pro-drug) Sodium 4-PHENYLBUTYRATE can be given in oral doses of 0.3 to 0.6 g per kilogram of body weight per day with NO ADVERSE REACTIONS
——————————————————————
Drug rapidly metabolized to PHENYLACETATE and PHENYLACETYLGLUTAMINE
—————————————————————— PHENYLACETATE (but not PHENYLACETYLGLUTAMINE) … CAN POTENTIATE EFFICACY OF OTHER DIFFERENTIATING AGENTS, such as cytotoxic drugs …
====================================== [3] 9/15/1992 we explored efficacy of PHENYLACETATE, an amino acid derivative with LOW TOXICITY INDEX WHEN ADMINISTERED TO HUMANS
—————————————————————— PHENYLACETATE, used alone or in combination with other drugs, might offer safe and effective new approach to treatment …
====================================== [4] 5/1993 NONTOXIC differentiation inducer, sodium PHENYLACETATE (NaPA)
——————————————————————
In vitro antineoplastic activity was observed with drug concentrations that have been achieved in humans with NO SIGNIFICANT TOXICITIES, suggesting PA, used alone or in combination with other antitumor agents, warrants evaluation in treatment of advanced prostatic cancer
====================================== [5] 10/1/1993 Sodium PHENYLACETATE (NaPA) and its precursor, sodium 4-PHENYLBUTYRATE (NaPB), can enhance HbF production in cultured erythroid progenitor derived from normal donors and patients with SS anemia or beta-thal, when used at pharmacologic concentrations
—————————————————————— NaPA and NaPB, BOTH ALREADY PROVEN SAFE AND EFFECTIVE IN TREATMENT OF CHILDREN …
====================================== [6] 2/15/1994 sodium PHENYLACETATE can induce cytostasis and reversal of malignant properties of cultured human glioblastoma cells, when used at pharmacological concentrations that are WELL TOLERATED BY CHILDREN AND ADULTS
——————————————————————
Systemic treatment of rats bearing intracranial gliomas resulted in significant tumor suppression with NO APPARENT TOXICITY to host
====================================== [7] 4/1/1994 Pg. 1690
—————————————————————— protocol underwent several modifications over 6-month period
——————————————————————
Interest in PHENYLACETATE as anticancer agent generated by reports that ANTINEOPLASTON AS2-1, a preparation which by weight is 80% PHENYLACETATE, displayed clinical antitumor activity (13)
—————————————————————— 17 patients (16 men / 1 woman) (36-75) median age 57
—————————————————————— Pg. 1693
—————————————————————— Clinical Toxicities. NO TOXICITY associated with bolus administration of drug
——————————————————————
Drug-related TOXICITY clearly related to serum
PHENYLACETATE concentration
——————————————————————
3 episodes of Central Nervous System (CNS)
TOXICITY, limited to CONFUSION
and LETHARGY and often preceded by emesis, occurred in patients treated at dose levels 3 and 4
—————————————————————— Symptoms resolved within 18 h of terminating drug infusion in all instances
—————————————————————— Pg. 1694
—————————————————————— PHENYLACETATE serum concentrations … were typically associated with CNS toxicity
——————————————————————
While ability to cross blood-brain barrier may underlie clinical improvement seen in patient with glioblastoma, could also explain dose-limiting side-effects of drug, i.e., nausea, vomiting, sedation, and confusion
——————————————————————
Limited experience with 150-mg/kg i.v. boluses suggests serum PHENYLACETATE concentrations occurring transiently
above 500 ug/ml are well tolerated
—————————————————————— Intermittent drug infusion should permit some drug washout to occur, thereby minimizing drug accumulation
——————————————————————
Predicts wide range of peak drug concentrations will be observed
——————————————————————
Possible these would be sufficiently transient so as not to produce CNS toxicity and troughs not prolonged as to abrogate antitumor activity of drug
—————————————————————— Dosing alternatives should be explored, our study indicates PHENYLACETATE can be safely administered by CIVI and result in clinical improvement in some patients with hormone-refractory
prostatic carcinoma and glioblastoma multiforme who failed conventional therapies
====================================== [8] 6/1/1994 PHENYLACETATE is naturally occurring plasma component that suppresses growth of tumor cells and induces differentiation in vitro
——————————————————————
Treatment with PHENYLACETATE extended survival … WITHOUT ASSOCIATED ADVERSE EFFECTS
====================================== [9] 9/1994 PHENYLACETATE, NONTOXIC differentiation inducer, can suppress growth of other neuroectodermal tumors, i.e., gliomas, in laboratory models and humans
====================================== [10] 4/1995 PHENYLACETATE, an inducer of tumor cytostasis and differentiation, shows promise as RELATIVELY NONTOXIC antineoplastic agent in models and humans
====================================== [11] 6/15/1995 Growth-inhibiting and differentiating effects of sodium PHENYLACETATE against hematopoietic and solid tumor cell lines has aroused clinical interest in use as anticancer drug
——————————————————————
In Phase I trial of PHENYLACETATE … commonly resulted in drug accumulation and REVERSIBLE DOSE-LIMITING NEUROLOGIC TOXICITY
——————————————————————
18 patients
—————————————————————— DOSE-LIMITING TOXICITY, consisting of REVERSIBLE CENTRAL NERVOUS SYSTEM DEPRESSION, observed for 3 patients at 2nd dose level
====================================== [12] 10/12/1995 aromatic fatty acid PHENYLACETATE, a common metabolite of phenylalanine, shows promise as a RELATIVELY NON-TOXIC drug for cancer treatment
====================================== [13] 10/1995 investigated effects of a NONTOXIC differentiation inducer, PHENYLACETATE (PA), on neuroectodermal tumor-derived cell lines
====================================== [14] 1995 Antineoplastons, firstly described by Burzynski, are naturally occurring peptides and amino acid derivatives which control neoplastic growth
—————————————————————— toxicological study of Antineoplastons A-10 and AS2-1 in combination with other anticancer agents or radiation in 42 patients 46 tumors with terminal stage cancer
—————————————————————— Antineoplaston A-10 oral formulation
14 – patients A-10 injectable formulation
25 – patients
—————————————————————— Antineoplaston AS2-1 oral formulation
33 – patients AS2-1 injectable formulation
10 – patients
—————————————————————— Major adverse effects that may have been related to agents used in combination with other conventional chemotherapeutic agents or radiation:
liver dysfunction
myelosuppression
general weakness THESE EFFECTS WEREN’T SEEN WHEN EITHER ANTINEOPLASTON WAS ADMINISTERED ALONE
—————————————————————— MINOR ADVERSE EFFECTS OBSERVED IN SINGLE USE OF EITHER ANTINEOPLASTON A-10 OR AS2-1:
reduced albumin
increased alkaline phosphatase
increased amylase
reduced cholesterol
peripheral edema
eosinophilia
fingers rigidity
excess gas
headache
hypertension
maculopapullar rash
palpitation adverse effects didn’t limit to continuation of either agent
—————————————————————— Antineoplaston A-10 and AS2-1 LESS TOXIC THAN CONVENTIONAL CHEMOTHERAPIES and useful in maintenance therapy for cancer patients
====================================== [15] 1996 Antineoplastons, first described by Burzynski, are naturally occurring peptides and amino acid derivatives which control neoplastic growth
——————————————————————
reported cytostatic inhibitory effect of A10 on human hepatocellular carcinoma cells and differentiation inducing effect of AS2-1 on various tumor cells suggest potential benefit for treatment of human hepatocellular carcinoma since tumor recurs frequently despite initial successful treatment
——————————————————————
Clinical experience of hepatocellular carcinoma (HCC) patient whose tumor, after incomplete trancathere arterial embolization (TAE) for a 7cm 7cm HCC, has been stable for more than 15 months during which time he has been taking Antineoplaston AS2-1 continuously WITHOUT ANY SERIOUS ADVERSE EFFECTS
====================================== [16] 5/1996
——————————————————————
In pursuit of alternative treatments for chemoresistant tumor cells, tested response of multidrug-resistant (MDR) tumor cell lines to aromatic fatty acids phenylacetate (PA) and phenylbutyrate (PB), 2 differentiation inducers currently in clinical trials
—————————————————————— Both compounds induced cytostasis and maturation of multidrug-resistant breast, ovarian, and colon carcinoma cells with no significant effect on cell viability
——————————————————————
MDR cells generally more sensitive to growth arrest by PA and PB than their parental counterparts
—————————————————————— PA and PB potentiated cytotoxic activity of doxorubicin against MDR cells
—————————————————————— Taken together, in vitro data indicate PA and PB, differentiation inducers of aromatic fatty acid class, may provide alternative approach to treatment of MDR tumors
====================================== [17] 12/1996 PHENYLACETATE (PA) and related aromatic fatty acids constitute novel class of RELATIVELY NONTOXIC antineoplastic agents
====================================== [18] 8/1997 aromatic fatty acids PHENYLACETATE (PA) and PHENYLBUTYRATE (PB) are novel antitumor agents currently under clinical evaluation
————————————————————
ability to induce tumor differentiation in laboratory models and LOW CLINICAL TOXICITY PROFILE makes them promising candidates for COMBINATION WITH CONVENTIONAL THERAPIES
====================================== [19] 1997 PHENYLACETATE and analogs represent new class of pleiotropic growth regulators that alter tumor cell biology by affecting gene expression at both transcriptional and post transcriptional levels
————————————————————
Based on findings, NaPA and NaPB entered clinical trials at National Cancer Institute
————————————————————
Ongoing phase I studies with NaPA, involving adults with prostate and brain cancer, confirmed therapeutic levels can be achieved WITH NO SIGNIFICANT TOXICITIES, and provide preliminary evidence for benefit to patients with advanced disease (Thibault et al., submitted)
====================================== [20] 10/1997 Sodium PHENYLACETATE (PA) and sodium PHENYLBUTYRATE (PB) are aromatic fatty acids that can effect differentiation in a variety of cell lines at doses that may be clinically attainable
—————————————————————— Pg. 1760
—————————————————————— PB has been successfully administered to patients with urea acid cycle disorders and sickle cell anemia for extended periods of time, and NO HEMATOLOGICAL TOXICITY has been reported
—————————————————————— Significant HEMATOLOGICAL TOXICITY was not reported in a Phase I trial of PA in patients with malignancy
—————————————————————— Pg. 1761
——————————————————————
Because of its ATTRACTIVE CLINICAL TOXICITY PROFILE, PB represents an excellent candidate for clinical trials in this group of disorders
====================================== [21] 11.–.12/1997 Antineoplaston AS2-1 exhibits cytostatic growth inhibition of human hepatocellular carcinoma cells in vitro and SHOWED MINIMUM ADVERSE EFFECTS in phase I clinical trial
====================================== [22] 6/1999 Burkitt’s lymphoma (BL) is readily treated malignancy, recurrences, as well as disease arising in immunosuppressed patients, are notoriously resistant to conventional therapeutic approaches
——————————————————————
Using in vitro models of EBV-transformed lymphoblastoid as well as BL cell lines, we demonstrate increased expression of genes coding for HLA class I and EBV latent proteins by differentiation inducer PHENYLBUTYRATE (PB)
—————————————————————— Aromatic fatty acid also caused cytostasis associated with sustained declines in c-myc expression, a direct antitumor effect that was independent of EBV status
——————————————————————
Findings may have clinical relevance because in vitro activity has been observed with PB concentrations that are
WELL TOLERATED and nonimmunosuppressive in humans, a desirable feature for different patient populations afflicted with this disease
====================================== [23] 8/2001 PHENYLBUTYRATE (PB) is aromatic fatty acid with multiple mechanisms of action including histone deacetylase inhibition
—————————————————————— Overall DRUG WELL TOLERATED with most common TOXICITIES being grade 1-2 DYSPEPSIA and FATIGUE
——————————————————————
Nonoverlapping dose-limiting TOXICITIES of NAUSEA/VOMITING and HYPOCALCEMIA were seen at 36 g/day
—————————————————————— PB (p.o.) IS WELL TOLERATED and achieves concentration in vivo shown to have biological activity in vitro
====================================== [24] 10/2001 Sodium PHENYLBUTYRATE (PB) demonstrates potent differentiating capacity in multiple hematopoietic and solid tumor cell lines
——————————————————————
Pharmacokinetics performed during and after first infusion period using validated high-performance liquid chromatographic assay and single compartmental pharmacokinetic model for PB and principal metabolite, PHENYLACETATE
—————————————————————— 24 patients with hormone refractory prostate cancer being predominant tumor type
—————————————————————— All evaluable for TOXICITY and response
——————————————————————
Dose escalated 150 to 515 mg/kg/day
——————————————————————
One patient at 515 mg/kg/day and one at 345 mg/kg/day experienced this DLT
——————————————————————
Maximum tolerated dose 410 mg/kg/day for 5 days
——————————————————————
Recommended Phase II dose 410 mg/kg/day for 120 h
—————————————————————— Dose-limiting TOXICITY (DLT) was neuro-cortical, exemplified by EXCESSIVE SOMNOLENCE and CONFUSION and accompanied by clinically significant HYPOKALEMIA, HYPONATREMIA, and HYPERURICEMIA
——————————————————————
Other TOXICITIES mild, including FATIGUE and NAUSEA
—————————————————————— DLT in Phase I study for infusional PB
given for 5 days every 21 days is neuro-cortical in nature
—————————————————————— TOXICITY resolved < or =12 h of discontinuing infusion
====================================== [25] 2003 Case of survival for nearly 8 years after treatment of unresectable multiple liver metastases from colon cancer, using microwave ablation and NONTOXIC ANTITUMOR AGENT, ANTINEOPLASTONS
——————————————————————
72-year-old man diagnosed with adenocarcinoma of ascending colon and 14 bilateral liver metastases underwent right hemicolectomy combined with microwave ablation of 6 metastatic liver tumors
—————————————————————— Antineoplaston A10 given intravenously, followed by oral antineoplaston AS2-1
——————————————————————
Patient underwent 2nd and 3rd microwave ablation of recurrent tumors, and has survived for nearly 8 years WITHOUT SUFFERING ANY SERIOUS ADVERSE EFFECTS
—————————————————————— Currently FREE FROM CANCER
——————————————————————
Demonstrates potential effectiveness of NONTOXIC ANTITUMOR AGENT, ANTINEOPLASTONS, for controlling liver metastases from colon cancer
====================================== [26] 4/2005 Determined maximum tolerated dose (MTD), TOXICITY profile of … oral sodium PHENYLBUTYRATE (PB) in patients with recurrent malignant gliomas
——————————————————————
All PB doses of 9, 18, and 27 g/day WELL TOLERATED
——————————————————————
At 36 g/day, 2 of 4 patients developed dose-limiting grade 3 FATIGUE and SOMNOLENCE
——————————————————————
At MTD of 27 g/day, one of 7 patients developed reversible grade 3 SOMNOLENCE
====================================== [27] 4/2007 PHENYLBUTYRATE (PBA), and its metabolite PHENYLACETATE (PAA), induce growth inhibition and cellular differentiation in multiple tumor models
——————————————————————
Conversion of PBA to PAA and PHENYLACETYLGLUTAMINE (PAG) documented without catabolic saturation
—————————————————————— THERAPY WELL TOLERATED OVERALL
——————————————————————
Common ADVERSE EFFECTS included grade 1 NAUSEA/VOMITING, FATIGUE, and LIGHTHEADEDNESS
—————————————————————— Dose limiting TOXICITIES were SHORT-TERM MEMORY LOSS, SEDATION, CONFUSION, NAUSEA, and VOMITING
——————————————————————
Administration of PBA twice-daily infusion schedule is SAFE
======================================
None of the above publications indicate that antineoplastons are toxic as Gorski would have people believe
12/12/2011 Gorski published his attempt at trying to explain why antineoplastons are supposedly toxic
====================================== What Dr. Stanislaw Burzynski doesn’t want you to know about antineoplastons
—————————————————————— http://scienceblogs.com/insolence/2011/12/12/what-dr-stanislaw-burzynski-doesnt-want/
====================================== Gorski posited:
“He’s also prescribing huge doses of antineoplastons (up to 25 g/kg/d for A10 and 80 mg/kg/d for AS-2.1, as we have seen). both of these are so far above the maximal tolerated dose of 300 mg/kg/d determined in the phase I trial I cited above as to be terrifying”
In support of his “theory”, Gorski provided a link to the National Cancer Institute (NCI) at the National Institutes of Health (NIH):
—————————————————————— http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/Table1
——————————————————————
However, as is the case with a lot of Gorski’s lame research, he makes you search for what he is referring to:
[14]Ba Primitive neuroectodermal tumor (13)
A10/AS2-1
Max dose: A10: 25 g/kg/d; AS2-1: 0.6 g/kg/d
Does this support Gorski’s “toxic theory”?
====================================== [28] 2005
—————————————————————— 5 years 7 months (1-11) median age
—————————————————————— 13 / 100% – children with recurrent disease or high risk
—————————————————————— 5 / 38% – weren’t treated earlier with radiation therapy or chemotherapy
—————————————————————— 3 / 23% – Complete Response
1 / 8% – Partial Response
4 / 31% – Stable Disease
5 / 38% – Progressive Disease
—————————————————————— 6 / 46% – Survived 5+ years from initiation of ANP
—————————————————————— Serious side effects:
1 – anemia
1 – fever
1 – granulocytopenia
—————————————————————— average dosage of A10 was 10.3 g/kg/d and of AS2-1 was 0.38 g/kg/d
—————————————————————— REDUCED TOXICITY MAKES ANP PROMISING for very young children, patients at high risk of complication of standard therapy, and patients with recurrent tumors
======================================
The above sure does NOT support Gorski’s “toxic theory”
When science based medicine keeps saying the following:
====================================== [9] 9/1994 increasing incidence of melanoma and POOR RESPONSIVENESS OF DISSEMINATED DISEASE TO CONVENTIONAL TREATMENT CALL FOR DEVELOPMENT OF NEW THERAPEUTIC APPROACHES
====================================== [29] 9/27/1995 (7/17/2006) Alterations in expression of ras oncogenes are characteristic of wide variety of human neoplasms
—————————————————————— Accumulating evidence has linked elevated ras expression with disease progression and FAILURE OF TUMORS TO RESPOND TO CONVENTIONAL THERAPIES, INCLUDING RADIOTHERAPY AND CERTAIN CHEMOTHERAPIES
—————————————————————— observations led us to investigate response of ras-transformed cells to differentiation-inducer PHENYLACETATE (PA)
—————————————————————— Interestingly, IN CONTRAST TO THEIR RELATIVE RESISTANCE TO RADIATION and doxorubicin, ras-transformed cells were significantly more sensitive to PA than their parental cells
====================================== [30] 5/1996 CYOTOXIC CHEMOTHERAPIES OFTEN GIVE RISE TO MULTIDRUG RESISTANCE, WHICH REMAINS MAJOR PROBLEM IN CANCER MANAGEMENT
———————————————————— IN PURSUIT OF ALTERNATIVE TREATMENTS FOR CHEMORESISTANT TUMOR CELLS, we tested response of multidrug-resistant (MDR) tumor cell lines to aromatic fatty acids PHENYLACETATE (PA) and PHENYLBUTYRATE (PB), 2 differentiation inducers currently in clinical trials
====================================== [15] 1996 Antineoplastons, first described by Burzynski, are naturally occurring peptides and amino acid derivatives which control neoplastic growth
——————————————————————
reported cytostatic inhibitory effect of A10 on human hepatocellular carcinoma cells and differentiation inducing effect of AS2-1 on various tumor cells suggest potential benefit for treatment of human hepatocellular carcinoma since TUMOR RECURS FREQUENTLY DESPITE INITIAL SUCCESSFUL TREATMENT
====================================== [31] 7/1997 Children with malignant GLIOMAS THAT PROGRESSED AFTER CONVENTIONAL THERAPY
—————————————————————— 0 / 0% – EXHIBITED CLEAR-CUT TUMOR regression
====================================== [32] 2000 treatment combination PRODUCED NO SIGNIFICANT CHANGE in overall POOR prognosis of patients
—————————————————————— Most tumors responded initially to treatment but RECCURED as study progressed
—————————————————————— Based on POOR RESULTS, recommend ALTERNATIVE TREATMENTS be tested in patients with this type of tumor
====================================== [33] At time of approval, NO RESULTS were available from randomized controlled trials in refractory ANAPLASTIC ASTROCYTOMA that show clinical benefit such as improvement in disease-related symptoms or prolonged survival
====================================== [34] 12/2000 NO CLEAR PROOF OF EFFICACY
—————————————————————— NO BETTER THAN SURVIVAL BEFORE THE INTRODUCTION OF temozolomide
====================================== [35] 2002 p53 tumor suppressor gene plays important role in protecting cells from developing undesirable proliferation
—————————————————————— Mutant p53 gene or malfunctioning p53 protein found in more than 50% of cancer cells impedes DNA repair or apoptosis induction
—————————————————————— MAY BE WHY SOME CANCERS GAIN RESISTANCE TO CHEMOTHERAPY AND RADIATION AND BECOME MORE RESISTANT AFTER FREQUENT CANCER TREATMENTS
====================================== [36] 2004 outcome for patients with either type of tumor is POOR when STANDARD multimodality THERAPY IS USED
—————————————————————— children are ideal candidates for INNOVATIVE TREATMENT approaches
—————————————————————— 33 / 100% – DIED OF DISEASE PROGRESSION
—————————————————————— administration of temozolomide after RT DIDN’T ALTER POOR PROGNOSIS associated with newly diagnosed diffuse BRAINSTEM GLIOMA in children
====================================== [37] 2/2008 addition of vincristine and oral VP-16 to standard external beam radiation causes moderate toxicity and DOESN’T IMPROVE SURVIVAL OF CHILDREN WITH DIFFUSE INTRINSIC BRAIN STEM GLIOMA
====================================== [38] 5/6/2009 Currently, NO DATA available from randomized controlled trials demonstrating improvement in disease-related symptoms or increased survival with Avastin in GLIOBLASTOMA
====================================== [39] 10/12/2011 Afinitor (ubependymal giant cell ASTROCYTOMA (SEGA) brain tumor)
—————————————————————— none of their tumors went away completely
====================================== [18] 8/1997 aromatic fatty acids PHENYLACETATE (PA) and PHENYLBUTYRATE (PB) are novel antitumor agents currently under clinical evaluation
————————————————————
ability to induce tumor differentiation in laboratory models and LOW CLINICALTOXICITY PROFILE makes them promising candidates for COMBINATION WITH CONVENTIONAL THERAPIES
======================================
So what does Gorski think is going to fill the void?
His clinical trial drug ?
The potentially profitable drug Gorski is in the process of conducting a clinical trial for is the ALS drug Riluzole, made by Sanofi-Aventis and marketed as Rilutek
Apparently, David Gorski has had his eye on that drug for a long time, but as a possible treatment for breast cancer
As suggested by a 2008-2009 webpage of a breast cancer website:
“Three years ago in another cancer (melanoma), Dr. Gorski’s collaborators found that glutamate might have a role in promoting the transformation of the pigmented cells in the skin (melanocytes) into the deadly skin cancer melanoma”
“More importantly for therapy, it was found that this protein can be blocked with drugs, and, specifically, in melanoma cell lines and tumor models of melanoma using a drug originally designed to treat ALS and already FDA-approved for that indication (Riluzole) can inhibit the growth of melanoma.”
———————————————————— http://www.ageofautism.com/2010/06/david-gorskis-financial-pharma-ties-what-he-didnt-tell-you.html
———————————————————— Better luck next time with your personal MUD-targeted Skeptic therapy Gorski
Blood 82(7):2203–2209 Department of Hematology, Hadassah University Hospital, Jerusalem, Israel
Fibach E, Prasanna P, Rodgers GP, SAMID D SAMID D References: 15, 19-21 and 32
� � � � � � � � � � � � � � � � � [6] 2/15/1994
� � � � � � � � � � � � � � � � � SAMID, D., Ram, Z., Hudgins, W. R., Shack, S., Liu, L., Waibridge, S., Oldfield, E. H., and Myers, C. E. Selective activity of PHENYLACETATE against malignant gliomas: resemblance to fetal brain damage in phenylketonuria. Cancer Res., 54: 891-895, 1993 http://www.ncbi.nlm.nih.gov/pubmed/8313377/
Cancer Res. 1994 Feb 15;54(4):891-5 http://www.ncbi.nlm.nih.gov/m/pubmed/8313377/
Cancer Res February 15, 1994 54; 891 http://cancerres.aacrjournals.org/content/54/4/891/
Cancer Res 1994;54:891-895
Clinical Pharmacology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
Work supported by funds from Elan Pharmaceutical Research Corporation through Cooperative Research and Development Agreement (CACR-0139)
� � � � � � � � � � � � � � � � � [7] 4/1/1994
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A phase I and pharmacokinetic study of intravenous PHENYLACETATE in patients with cancer http://www.ncbi.nlm.nih.gov/pubmed/8137283
Cancer Res. 1994 Apr 1;54(7):1690-4 http://www.ncbi.nlm.nih.gov/m/pubmed/8137283
Cancer Res 54(7):1690-4 (1994), PMID.8137283 http://m.cancerres.aacrjournals.org/content/54/7/1690.abstract
Clinical Pharmacology Branch, National Cancer Institute, NIH, Bethesda, Maryland
Eicosanoids and Other Bioactive Lipids in Cancer, Inflammation, and Radiation Injury 2
Advances in Experimental Medicine and Biology Volume 400, 1997, pp 501-505
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, MD USA D D SAMID, W R WR Hudgins, … C E CE Myers
� � � � � � � � � � � � � � � � [20] 10/1997
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Impact of the putative differentiating agents sodium PHENYLBUTYRATE and sodium PHENYLACETATE on proliferation, differentiation, and apoptosis of primary neoplastic myeloid cells http://www.ncbi.nlm.nih.gov/pubmed/9815560/
Clin Cancer Res. 1997 Oct;3(10):1755-62 http://www.ncbi.nlm.nih.gov/m/pubmed/9815560/
Clin Cancer Res October 1997 3; 1755 http://m.clincancerres.aacrjournals.org/content/3/10/1755.full.pd
Clin Cancer Res. 1997a;3:1755–1762 http://m.clincancerres.aacrjournals.org/content/3/10/1755.abstract The Johns Hopkins Oncology Center, Baltimore, Maryland, USA
The New Approaches to Brain Tumor Therapy CNS Consortium, Winship Cancer Institute, Emory University, Atlanta, GA, USA
Buckner Reference: 3
SAMID D References: 12, 17 and 19-21
� � � � � � � � � � � � � � � � � [27] 4/2007
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Phase I dose escalation clinical trial of PHENYLBUTYRATE sodium administered twice daily to patients with advanced solid tumors http://www.ncbi.nlm.nih.gov/pubmed/17053987
Invest New Drugs. 2007 Apr;25(2):131-8. Epub 2006 Oct 20 http://www.ncbi.nlm.nih.gov/m/pubmed/17053987
Investigational New Drugs
April 2007, Volume 25, Issue 2, pp 131-138 http://link.springer.com/article/10.1007%2Fs10637-006-9017-4
Invest New Drugs 25(2):131-8 (2007), PMID.17053987 Department of Medicine, Memorial Sloan-Kettering Cancer Center, Joan and Sanford I. Weill Medical College of Cornell Medical Center, New York, New York, USA
Luis H LH Camacho, Jon J Olson, … Mark G MG Malkin SAMID D References: 4-5, 7, 20, 24, 30 and 32-38
� � � � � � � � � � � � � � � � � [28] 2005
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14. Burzynski SR, Weaver RA, Janicki T, et al.: Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with antineoplastons A10 and AS2-1. Integr Cancer Ther 4 (2): 168-77, 2005 http://www.ncbi.nlm.nih.gov/pubmed/15911929/
Integr Cancer Ther. 2005 Jun;4(2):168-77 http://www.ncbi.nlm.nih.gov/m/pubmed/15911929/
� � � � � � � � � � � � � � � � � [29] 9/27/1995
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Increased susceptibility of ras-transformed cells to PHENYLACETATE is associated with inhibition of p21ras isoprenylation and phenotypic reversion. Int J Cancer 63:124-129, 1995 http://www.ncbi.nlm.nih.gov/pubmed/7558439/
Int J Cancer. 1995 Sep 27;63(1):124-9 http://www.ncbi.nlm.nih.gov/m/pubmed/7558439/
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, MD, USA http://onlinelibrary.wiley.com/doi/10.1002/ijc.2910630122/abstract
Int J Cancer 63:124-129, 1995
Int J Cancer. 1995 Sep 27;63(1):124-9. http://onlinelibrary.wiley.com/doi/10.1002/ijc.2910630122/references
International Journal of Cancer
Volume 63, Issue 1, Article first published online: 17 JUL 2006
DOI: 10.1002/ijc.2910630122
Shack S, Chen L-C, Miller AC, et al: (SAMID D) http://onlinelibrary.wiley.com/doi/10.1002/ijc.2910630122/abstract
Shack, S., Chen, L-C., Miller, A. C., Danesi, A., and SAMID, D. Int. J. Cancer, 63: 124-129, 1995
� � � � � � � � � � � � � � � � � [30] 5/1996
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Shack, S., Miller, A., Liu, L., Prasanna, P., Thibault, A., and SAMID, D.. Vulnerability of MULTIDRUG-RESISTANT TUMOR CELLS to the aromatic fatty acids PHENYLACETATE and PHENYLBUTYRATE. Clin. Cancer Res., 2: 865-872, 1996 http://www.ncbi.nlm.nih.gov/pubmed/9816242/
Clin Cancer Res. 1996 May;2(5):865-72 http://www.ncbi.nlm.nih.gov/m/pubmed/9816242/
Clinical Pharmacology Branch, National Cancer Institute, Bethesda, Maryland 20892, USA http://m.clincancerres.aacrjournals.org/content/2/5/865.abstract
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