Dana-Farber Cancer Board Member discusses Dr. Burzynski, Antineoplastons, & Industry

Dana-Farber Cancer Institute Board of Directors Member James Rappaport discusses Dr. Burzynski and The Cancer Industry
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“When you look at what is going on and how Dr. Burzynski’s being handled, it is clearly a function of, (?), anytime you have big business, big government, big labor, Big Pharma, Big Cancer Industry, whatever, they become so, wrapped up in protecting the institution; whatever it is, that they forget what their fundamental job is, you know, and what’s happened with Big Pharma and, and Big Cancer, is they kinda, you know, they’ve forgotten to be curious that there might be other op, opportunities and options out there, and they’re focused on protecting their turf”
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00:41 – Peer-review chauvinism
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“Most of the stuff is peer-reviewed, in order to get into, the starting gate, of their process”

“Well, if you’re all of the peers, are vested in one piece of the business, something new, is frightening, and is not going to be given the same shot, as something that’s within the construct of what they’re used to”

“That’s the problem, uh, and the idea that something different; less catastrophic to the body, um, could possibly, uh, work, would upset all of their training, all of their thinking, and, it, it’s very hard for them to, to to do that”
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01:24 – The anointed Evangelical Guardians of the Status Quo
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“The doctors I know and, and the clinicians I know, and, and these people are evangelical”

“I mean, they are hugely, vested and invested, in doing what they believe is very important and good work”

“It helps them get up in the morning, to go to work”

“So, folks who are, invested that kind of, uh, you know, zealous way, you know, are going to look at anything that isn’t within that, that, that, that vision, you know, they’re going to look askance at it”

“They’re going to look at, say that, that, that’s really weird, or, that’s a charlatan”

“What they were in essence saying is, that if you do, the Burzynski treatment regimen, you are foregoing the treatments that we know and understand, and thus we can’t, guarantee that you’re going to have a success”

“Well, you can’t guarantee that you’re going to have a success with chemotherapy, or the normal regimens of chemotherapy

“So, they came from a place of saying: ‘We are protecting you from going down and taking a, uh, the placebo approach,’ which is the way they look at it”

“The fact that it’s been effective, and the fact that, uh, you know, when you go through the numbers, uh, and the analysis, and you go through, uh, that if you’ve not gone through chemotherapy, and you go through the Burzynski’s treatment your odds are 2 or 3 times as high, even if you have gone through chemotherapy it’s 1 or 2 times as high”

“You know, those are, un, those are high enough numbers to push the needle, and, oh by the way, it’s less expensive, than Big Pharma
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02:56 – Protecting the business at all costs
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“Which is another big piece”

Big Pharma is protecting a huge, multi-billion dollar business, and they’re going to protect it to the death, even, to the adverse impact of patient outcomes”

“They won’t say it that way, and, but that fact of the matter is, if you’ve got an approach out here which could be significantly, less costly, and significantly less adversely impact-full, to the patient, um, then you’re gonna, um, you, you, you can understand why they’re, to doing”

“You don’t have to agree with it, but you can at least understand why they’re taking the position that they’re taking”
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03:34 – The fiber of an innovator’s background
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“I think that what is amazing is that Dr. Burzynski has had a vision, and a passion, and a zeal, for 40-odd years, put up with being called everything, short of, and probably even including ‘Witch Doctor,’ um, because of his firm belief that he can save people’s lives, and, and what that says about his character and his just his, the fiber of his backbone, to, um, to be willing to take that on”

“You know, you’re talking about a man who spent the last 40 years, um, you know, working on, on a different form of treatment that is more patient friendly, than chemotherapy

“You know, I explain to people about, you know, what chemotherapy is”

“What chemotherapy is, is putting poison in your body”

“Killing everything that is fast-growing in your body”

“Starting first with cancer cells”

“Then next with white-blood cells”

“Then with your hair”

“Then with your, you know, the inside lining of your mouth”

“Um, then your fingernails”

“I mean, you know, that, that’s what it’s meant to do, and what you essentially do is you give this chemotherapy to, as much as a person can take, uh, uh, uh, in order to, you know, in, in, in order to get out the other end where’ve you’ve killed cancer and hopeful not everybody else or the patient”

“That’s what it is”

“So, if you’ve got a different approach, which is, essentially is saying, well, you know, we’re not, we’re gonna go in and stop the cancer cells from growing and we’re going to actually, and, uh and work on shrinking them, without the ancillary effects, is pretty powerful, you know, and, uh, and you would think that, that, that, the Big Cancer Industry would say: ‘That’s something we outta be looking at'”

Burzynski needs to be given the right to prove the efficacy of his treatment, and if he can, uh, show that his treatments are as or more effective, and / or, significantly better for the patient, with better patient outcomes and, and limited side effects, he’s gotta be given that opportunity to compete out in the marketplace”

“That’s what America’s about”
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12/4/2013Jim Rappaport, Board Member of Dana-Farber Cancer Institute discusses Dr. Burzynski and the obstacles he faces within a Cancer Ind (5:49)
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http://www.dana-farber.org/uploadedFiles/Library/modules/IRS_990_Form/dana-farber-board-of-trustees.pdf
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http://www.rappaportfoundation.org/about/board.html
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http://www.specialtyhospitalsofamerica.com/jim-rappaport/
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http://www.petangelworldservices.com/board.php?bio=rappaport
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http://www.newbostonfund.com/Company-Overview/Executive-Team/James-Rappaport.asp
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“The Skeptics” are “debatable”

In the aftermath of the Google+ Hangout …

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I remember seeing one of “The Skeptics™” continuing to twit at a pro-Burzynski Twitter user, after they were asked to stop

If I find it I’ll post it here

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Guy, what’s your point ?

That I’m giving “The Skeptics™” some of their own “medicine” and they don’t like it ?

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@SceptiGuy, Is it true that a “Skeptic™” sucker is born every minute ?

Because if you believe Wikipedia’s lies, “Orac” has something for sale
http://en.wikipedia.org/wiki/Category:Suspected_Wikipedia_sockpuppets_of_Didymus_Judas_Thomas

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I’m waiting for someone to “prove it”

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Guy, you have absolutely NO credibility:

2 – Terminated (Withdrawn due to slow enrollment)

7 – Withdrawn (Study withdrawn prior to enrollment)

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

Now research the 52

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Guy Chapman, you are the epitome of “massive cognitive dissonance”

After all, you thought I was “Astroturfwatch” based on absolutely nothing

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Awwwwwww … and if she posts garbage as she has also done in the past, I will call her out on it

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Except I never said that, and you can’t prove I said that

Maybe I should misquote you ?

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David, this is the first question for Bob:

3/4/2013 – 7:58pm – You posted on Colorado Public Television (CPT12):

“ANP is toxic as anything!”

So you’re saying what ?

ANP is as toxic as water ?

David, do you understand that question, or is it too difficult for you ?

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David James, try this:

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@StortSkeptic, I’ve tried to make it as easy as possible for “The Skeptics™” to leave comments on my blog without having to authenticate/sign in

Why don’t you grow some “grapefruits” and ask away ?

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Why can’t you think the way you twit ?

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David, where’s your citation(s), reference(s), and / or link(s) that support your position as to when you think Burzynski was required to publish ?

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Trust me

I thoroughly enjoyed the rest while Bob yapped away about things he’s blogged about already, and I’ve already blogged about

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Yeah … waiting for those citations, references, and / or links

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Actions speak louder than words 🙂
Bobby Blaskiewicz Bows Up ‘Bout Burzynski:
https://stanislawrajmundburzynski.wordpress.com/2013/09/24/bobby-blaskiewicz-bows-up-bout-burzynski/

The Skeptics @Majikthyse reveals madjik research skilz

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21CFR601

Subpart F–Confidentiality of Information

Sec. 601.50

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

(a) The existence of an IND notice for a biological product will not be disclosed by the Food and Drug Administration unless it has previously been publicly disclosed or acknowledged

“The Skeptics™” #FAIL
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REFERENCES:
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[1] – Les Rose (@Majikthyse) tweeted at 2:21pm – 25 Sep 13:

@dianthusmed @cappsie Hmm…FDA refused my request, saying all info subject to IND is confidential. We shall see! #Burzynski
https://twitter.com/Majikthyse/status/382947974143160320
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[2] – Code of Federal Regulations

Title 21, Volume 7

Revised as of April.1, 2013

TITLE 21–FOOD AND DRUGS

CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER F–BIOLOGICS

PART 601 LICENSING
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http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=601&showFR=1&subpartNode=21:7.0.1.1.2.6
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josephinejones (@_JosephineJones), D Nile ist http://josephinejones.wordpress.com/2013/01/23/happy-birthday-dr-burzynski-and-goodbye-antineoplastons/comment-page-1/#comment-8921

https://twitter.com/_JosephineJones/status/381889639122231296
[1]

“Please provide evidence that people are being paid to write about Burzynski”

“The very idea is ludicrous” [2]
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“It was probably the worst $15 I ever spent, but at least it’s tax-deductable for this blog” [3]

So, basically Gorski has money that he would otherwise have to pay instead of it being “tax-deductable” for his blog
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“As far as saving lives is concerned – as I’ve explained already – Burzynski has never provided reliable evidence that antineoplastons work, despite having used them on cancer patients since the 1970s, and despite decades of “clinical trials””
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He does NOT need to

The FDA has already done it for him

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″ [4]
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9/3/2004 – FDA granted “orphan drug designation” (“ODD”) for Antineoplastons (A10 & AS2-1 Antineoplaston) for treatment of patients with brain stem glioma [5]

.10/30/2008 – FDA granted “orphan drug designation” (“ODD”) for Antineoplastons (A10 and AS2-1 Antineoplaston) for treatment of gliomas [5]
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9/2004 – Antineoplaston AS2-1 received orphan drug status from the FDA for the treatment of brain stem glioma [6]

2008 – US orphan drug designation was extended to include all gliomas [6]
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80 evaluable patients in Phase II trial showed IV antineoplastons therapy resulted in: [7]

32% – complete or partial responses
43% – stable disease

36% – Overall survival at 2 years
25% – Overall survival at 5 years
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“Indeed, as I’ve also explained, Burzynski can’t advertise antineoplastons as safe and effective and can no longer give antineoplastons to new patients”
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He doesn’t need to

The FDA has already done it for him
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“Instead, antineoplastons seem to be promoted by word of mouth – by which I mean pseudonymous comments on blogs, online forums and social media”
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What’s your point ?

JosephineJones is a pseudonym
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“And if you’re going to accuse people of writing “shit”, please specify who you refer to and what your specific objections are”
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Well, I just proved that you were writing “shit”
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“If you believe anything I’ve written is inaccurate or in any way misleading, I would appreciate it if you could let me know so I can take steps to correct or clarify”
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Reply

Didymus Judas Thomas on September 23, 2013 at 3:23 pm

Your comment is awaiting moderation

JJ, you know you do NOT want any evidence

That’s why you block people on your blog

DJT 🙂
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REFERENCES:
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[1] – 9/22/2013 – josephinejones on September 22, 2013 at 10:08 pm
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http://josephinejones.wordpress.com/2013/01/23/happy-birthday-dr-burzynski-and-goodbye-antineoplastons/comment-page-1/#comment-8921
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[2] – 9/22/2013 – Josephine Jones (@_JosephineJones) tweeted at 4:15pm – 22 Sep 13:

“THE SKEPTICS ARE PAID TO PUT THIS SHIT ABOUT BURZYNSKI” josephinejones.wordpress.com/2013/01/23/hap… Any evidence for that? #Burzynski
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[3] – 6/3/2013 – In which the latest movie about Stanislaw Burzynski “cancer cure” is reviewed…with Insolence
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http://scienceblogs.com/insolence/2013/06/03/in-which-the-latest-movie-about-stanislaw-burzynskis-cancer-cure-is-reviewed-with-insolence/
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[4] – 4/25/2013 – Burzynski: The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective:
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https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-the-fdas-drug-review-process-ensuring-drugs-are-safe-and-effective/
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[5] – 2013
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http://biz.yahoo.com/e/130715/bzyr10-q.html
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[6]
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http://www.medmk.com/mm/add/1068_ad3.htm
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[7] – BioCentury

5/18/2009 Volume217 Number 22

Clinical Results

BioCentury Part II MAY 18, 2009 PAGE B10 OF 22

Burzynski Research Institute Inc. (OTCBB:BZYR), Houston, Texas

Product: Antineoplastons (ANP) therapy

Business: Cancer

BioCentury Part II MAY 18, 2009 PAGE B11 OF 22

Description: Combination of Atengenal (antineoplaston A10) and Astugenal (antineoplaston AS2-1)

Indication: Treat advanced non-operable brainstem glioma (BSG)

Endpoint: Response rate and overall survival

Data presented at Quadrennial Meeting of the World Federation of Neuro-Oncology in Yokohama
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http://www.pluristem.com/e_pr/051809bc.pdf
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Critiquing: Watford Observer – ‘He said he hoped to cure my daughter’

6/7/2013 the Watford Observer published this article By Kathryn Snowdon [1]

“The mother of Luna Petagine has cast doubt on the expensive treatment the family sought in America during the Oxhey girl’s four-year battle with cancer
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Expensive treatment,” based on what objective criteria ? [2]
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BBC Panorama this week aired an investigation into Doctor Stanislaw Burzynski’s cancer clinic in Texas, where hundreds of children – normally terminally ill – go and seek treatment”

“Luna, who was five-years-old when she died last year, was a patient at The Burzynski Clinic after her parents were told the physician could cure their daughter, despite Great Ormond Street Hospital doctors saying little more could be done for her”
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Why the conflicting statements ?

a) “her parents were told the physician could cure their daughter”

b) “The NHS are telling me my daughter’s going to die and this man is telling me that he thinks he can cure her.”

c) “He said he hoped to cure my daughter

d) “The plan was to try and cure Luna.”
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Luna’s mother, Lucy Petagine, of Raglan Gardens, said there was no doubt in her mind she was going to send her daughter to Dr Burzynski

“Mrs Petagine said:”

“Of course I’m going to go with him

If anyone had knocked on my door and said

‘here if you try this it will work’

“then yeah I would have tried it because I was in desperation”

“The NHS are telling me my daughter’s going to die and this man is telling me that he thinks he can cure her.”

“Mrs Petagine added:”

“It was all about hope

He said he hoped to cure my daughter

The plan was to try and cure Luna.”

“In order to finance the treatment, which the family believed could be life-saving, more than £100,000 was raised and in September 2011 they travelled to America”

“However, Mrs Petagine said the treatment at The Burzynski Clinic was actually killing her daughter

“She added:”

The treatment was – what was happening – was actually killing Luna because it put this pressure on her brain stem.”
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Why did Mrs Petagine say that “the treatment at The Burzynski Clinic”“was actually killing Luna” ?

Did someone tell her this, or was this her personal opinion ?

We know from Burzynski’s 3/2004 publication that:

“The reason for 50% Progressive Disease (PD) in studies is long dose-escalation process, which extends to more than a month’s time period, before the optimal dosage is reached” [3]
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“In response to Panorama’s questioning and claims that he was merely selling hope to vulnerable families, Dr Burzynski said:”

“Can you imagine that the US government… they would allow me to be here if I just sell hope?”
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Isn’t every cancer treatment “selling hope to vulnerable families”?

Isn’t every cancer clinical trial “selling hope to vulnerable families” ?
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“The treatment has not been approved by the American Food and Drug Administration (FDA)
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12/2008 – Burzynski’s publication advised:

“In 2004 the FDA granted orphan drug designation for antineoplastons A10 and AS2-1 for the treatment of brainstem glioma” [4]

9/2012“The FDA granted Orphan Drug designation for Antineoplastons A10 and AS2-1 for the treatment of gliomas, in 2009″ [5]
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“A month into Luna’s therapy, an MRI revealed the tumour had grown, pressing on Luna’s brain stem and causing her breathing problems and facial palsy”

Mrs Petagine said:”

“They said the tumour’s grown and we were like ‘how could it have grown this quickly, this doesn’t make sense’.”
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What does Mrs Petagine mean when she said:

‘how could it have grown this quickly, this doesn’t make sense’ ?

We know from [3] above, that the tumor is likely to grow before the medicine has reached it’s optimal dosage, and the tumor starts to decrease in size
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Luna had to be admitted to intensive care in Texas Children’s Hospital

Mrs Petagine said:”

Texas Children’s hate The Burzynski Clinic

“They said they have to clean up all his mess”

“The second you walk in the door they look at your child and they did actually say to us ‘are you a Burzynski family?’”
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If Texas Children’s actually does that with every child patient that comes in the door, that would be a really stupid bias to foist on some unsuspecting parent
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“Luna died in August last year”
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Unfortunately, the article does not tell the reader what happened ?

Was Luna taken off of antineoplaston therapy?

Or was she still on the treatment when she unfortunately passed ?
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REFERENCES:
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[1] – 9:50am Friday 7th June 2013, By Kathryn Snowdon
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http://www.watfordobserver.co.uk/news/10470494.print/
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[2] – 9/22/2013 – Critiquing Wikipedia: Burzynski Clinic – 2013 BBC documentary, Curing cancer or ‘selling hope’ to the vulnerable?
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https://stanislawrajmundburzynski.wordpress.com/2013/09/22/critiquing-wikipedia-burzynski-clinic-2013-bbc-documentary-curing-cancer-or-selling-hope-to-the-vulnerable/
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[3] – Review Articles on Clinical Trials:

1. 3/2004 – The Present State of Antineoplaston Research
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Integrative Cancer Therapies 2004;3:47-58
Volume 3, No. 1, March 2004

DOI: 10.1177/1534735-403261964

Volume 3 Number 1.March.2004

Pg. 50
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http://www.burzynskiclinic.com/images/stories/Publications/994.pdf
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[4] – 12/2008 – Patil, S., Burzynski, S., Chittur, S., Mrowczynski, E., Grela, K. The ingredients of antineoplaston AS2-1 down-regulate glycolysis pathways in glioblastoma cells. Neuro-Oncology 2008; 10:1148

Volume 10 Issue 6.December.2008
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http://www.burzynskiclinic.com/images/stories/Publications/7897.pdf
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[5] – 9/2012 – Patil, S., Burzynski S.R., Mrowczynski, E., Grela, K. P.003. Phenylacetylglutaminate in combination with Phenylbutyrate effectively inhibits growth of brain tumor cell In Vitro. Neuro-Oncology 2012;14(Suppl. 3):iii16

Volume 14 Supplement 3 September 2012
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http://www.burzynskiclinic.com/images/stories/Publications/9291.pdf
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Critiquing: The Institute of Medicine report on cancer care: Is the system “in crisis”?

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

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

“Americans love a winner”

“Americans will not tolerate a loser”

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

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

He’s the epitome of the word “loser”

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

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

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

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

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

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

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

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

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

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

It’s a general problem

However, as far as doctors who should have been shut down a long time ago, “Orac” takes the cake
http://youtu.be/zStIm0gNnUw

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

[7] – Who could do it better than someone like Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH) who Burzynski had to deal with:

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

“However, your letter conspicuously fails to address them

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

Pg. 2

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

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

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

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

“which genes are targeted by antineoplastons“?

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

Volume 5 Issue 4 October 2003

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

Volume 9 Issue 4 October 2007

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

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

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

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

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

Volume 10 Issue 5 October 2008

Affymetrix Human Genome

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

ORC1L and CDC6

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

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

MAD2L1, BUB1 and CDC20

p21, p53, and GADD45A

p21/CDKN1A, and PPM1A

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

Volume 10 Issue 6 December 2008

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

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

A total human gene array screen using the Affymetrix Human Genome

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

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

Volume 12 Supplement 4 November 2010

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

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

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

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

Using the total human microarray screen (Affymetrix)

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

Volume 14 Supplement 3 September 2012

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

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

AKT2

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

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

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

What did you do, Gorski ?

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

[8] – 1993 (10/26/1993) – Burzynski to Dr. Michael A. Friedman

This page is linked to:
=====================================
Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
======================================
[8] – 1993 (10/26/1993) – Burzynski to Dr. Michael A. Friedman
——————————————————————
Dear Dr. Friedman,

In response to your letter of 10/20/1993, it is difficult for me to understand why the entire 1st page of your letter is used to discuss the simplest issue:

that adults should use a different dosage than that used for children

Since you agreed to the study procedure of Protocol BT-6 as recommended in my letter of 6/9/1993, we have not requested any changes in the structure of treatment which was accepted by Memorial-Sloan-Kettering Cancer Center (MSKCC)

As you confirmed in your letter of 10/20/1993, you know very well that since 4/1/1993 of this year my recommended dosage of Antineoplaston AS2-1 for adults is 0.4g/kg/24h

Again, I confirmed that this is the right dosage for adults in my letter to Dr. Shoemaker of 8/24/1993

Yet, for no apparent reason, you insist on using in the adult treatment protocol the dosage 0.6g/kg/24h which I recommend for children

It is generally known that a child’s body weight is much lower than that of adults

This should be reflected in the escalation of the dosages

My recommendation as to how to escalate the dosages for adults was submitted to the NCI on 6/4/1992

Yet, for no apparent reason the MSKCC protocol, which is designed for adults, escalates the dosages in the small increments recommended for children

The principle behind dose escalation is to accomplish the maximum dosage in 3 to 5 days, not 3 to 4 weeks, which would expose the patient to the unnecessary risk of tumor progression

I appreciate very much that you have finally decided to follow my recommendation regarding dosage and dosage escalation

Regarding the number of patients to be treated at MSKCC, the contradictory, incomplete, and inconsistent information is being supplied by you

The MSKCC’s protocol of 4/16/1993, 7/13/1993, and 8/30/1993 describe the treatment of 35,

Pg. 2

but not 70 patients

(please see paragraph 12.1, pg. 10 of the protocol, which is attached)

It was our understanding that 35 patients would be treated at MSKCC and at the Mayo Clinic

I never agreed for the treatment of 70 patients at MSKCC

Since I have to produce the medicine for the trial and pay for it, it is vitally important to me to know how many patients will be treated

The treatment of an additional 35 patients may cost up to 2 million dollars

Contrary to the information given by NCI that we received the money for the production of medicine, this money went apparently into a “black hole”

(“Black Holism,” The Village Voice, 7/29/1993, enclosed)

We have received none of the money which the Office of Alternative Medicine gave to the NCI for funding the trials with our medicine

Contrary to the opinion expressed in your letter, we see no reason for modifying Fleming’s Phase II clinical trial design and introducing more stringent than usual criteria for response evaluation

We request that Fleming’s original design be used, which calls for the initial treatment of 15 patients with at least one responder, instead of 20 patients and 2 responders

Given the fact that there is no existing treatment effective in this type of cancer, one responder in 15 is certainly significant and would be reason enough to expand the trial

I found your your requirement for 14 days to complete scans and laboratory tests prior to treatment very interesting

It is a very well known fact that glioblastoma multiforme is such an active tumor that if 2 weeks elapses from the time of the scan and the beginning of treatment, the tumor may increase by more than 50%

This means that even before the patient begins treatment, he can be classified as an increasing disease case

In most of the hospitals in the U.S., including out tiny clinic, all pretreatment tests including the scans can be done in one day

Therefore, I insist that the pretreatment evaluation, including brain scans, be done within 7 days from the time treatment begins

Regarding the Karnofsky Performance Status (PS), it is unclear to me why you have backed off from your own recommendation in your letter of 5/5/1993 (copy attached) that “patients with Karnofsky PS of below 70% should be excluded”

I am requesting that as recommended by NCI, the patient’s PS should be 70% to 100%

I agree that both scan data and neurological assessment can be described in the analysis of response, but the decision of how to classify response should be based on tumor measurements alone

All of these patients will have been extensively treated before

As the result of previous neurotoxic treatments, a number of these patients will deteriorate neurologically even if the Antineoplastons eradicate the

Pg. 3

tumor

The purpose of the protocol is to evaluate the antitumor effect, not to prove that Antineoplastons can repair brain damage resulting from chemotherapy and radiation

In this 1st independent study with Antineoplastons, in order to assure that patients will derive the most benefit from the treatment, it is critically important to schedule more frequent evaluations of the data than waiting until after the accrual of 14 patients, i.e. waiting 9 months

(Based on an accrual of 2 patients per month, if we wait until 14 patients are accrued and treated, 9 months will pass before the 1st evaluation takes place)

Therefore, I request that reviews of the studies be performed after the treatment of each group of 5 patients, i.e. after 6 months

I agree, however, that you will provide the Theradex printout to us as you receive it

In addition to patient welfare, there is another reason for more frequent patient evaluations

As you stated in your letter, I have no doubt that the investigators at MSKCC have extensive experience treating glioma

However, MSKCC is known to be biased against Antineoplastons

At least 3 researchers associated with MSKCC published willful misrepresentations and distortions about Antineoplaston research

Because of the controversial nature of the upcoming Antineoplaston clinical trials, it is essential that they are conducted in a manner beyond any suspicion of bias

Contrary to the opinion expressed in your letter, NCI is responsible for the trial’s delay

As you well know, the NCI selected an MSKCC investigator in 9/1992

In spite of our repeated requests, 8 months were waisted before the NCI produced the 1st draft of the protocol

As promised in my letter to you of 11/11/1992, the supply of Antineoplastons has been prepared and was shown to Ms. Mary McCabe of NCI during the site visit on 2/9/1993

The medicine was ready to be released pending final approval approval of the labels by the FDA and our final QC inspection

The medicine will be sent to you immediately once you make the corrections to the protocol that we have requested

Since you mentioned that patient recruitment has begun already, I would be glad to accept these patients immediately under my care and offer them free medicine as we wait for the protocol to be revised and the treatment at MSKCC to begin

The MSKCC protocol in its current form would threaten the welfare of these patients

In your letter you stated that your mission is to find and develop better therapies for cancer patients, and that your only obligation is to those patients

However, the way

Pg. 4

you proceed leads me to question that for the following reasons:

1) Out of numerous cancer treatment centers, you selected 2:

MSKCC and Mayo Clinic, which are known to be strongly biased against alternative treatments

In the past doctors associated with MSKCC have voiced strong opposition to Antineoplaston therapy and have published articles full of misrepresentations and distortions

2) The protocol approved by you will allow the disease to progress between the pretreatment evaluation and the beginning of treatment

3) Due to the slow escalation of dosages, patients will most likely have marked increase of tumor size beginning the treatment at the correct dosage level

4) In spite of my numerous requests (letters of 4/29/1993, 6/9/1993, and 8/24/1993) to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991 to have a separate clinical trial for glioblastoma multiforme and anaplastic astrocytoma, you continue to combine both types of tumors together

Even in your most recent stratification strategy submitted to the FDA, you are planning to treat initially 20 patients without specifying whether those 20 patients are per each stratum (glioblastoma vs. anaplastic astrocytoma), or whether this initial group of 20 patients consist of a mixture of glioblastoma and anaplastic astrocytoma

If the latter is the case, then we can expect that among these 1st 20 patients, most will have glioblastoma, which is more common and more difficult to treat

In case of treatment failure in these 20 patients, it will be easy to make the statement that Antineoplastons do not have therapeutic effect in both tumor categories

5) The protocol now states in paragraph 10.2, 10.3, and 10.4 that the objective decrease of tumor size is not enough to be considered a true response to treatment, that there must also be improvement in neurological function

As I explained in my letter of 10/13/1993 to Dr. Greenblatt, it is not unusual in my practice to see patients whose tumor has disappeared, but who have deteriorated neurologically as the result of delayed toxicity from radiation therapy and chemotherapy

Since these patients in the MSKCC study have been pretreated, and since there has been no indication that anything, including Antineoplastons, can repair brain damage caused by chemotherapy and radiation, I request that the criteria including restored neurological functioning be removed from paragraphs 10.2, 10.3, and 10.4 of the protocol

Pg, 5

6) Finally, by limiting our access to the data and not allowing review until after the 1st 14 patients have been treated, it would be easy to deviate from the protocol and supply inadequate treatment, and then claim that due to the the failure of the 1st 14 patients it would be a waste of the taxpayers money to proceed with further treatment

Your final statements that you are ready to proceed with the treatment with Antineoplastons without our participation caught me by surprise

It is hard to imagine that a Federal employee would consider patent infringement, thus infringing on the patent rights of thousands of our shareholders

Once again, I urge you to take our requests seriously, honor the guidelines of the NCI’s Decision Network on 12/2/1991, and make proper corrections to the protocol, so that objective clinical studies can begin immediately

In the meantime, I would be glad to treat for free all the patients presently recruited, and will submit progress reports weekly for the NCI’s review and evaluation

SRB/cf

cc:

Senator Joseph Biden
Senator Barbara Boxer
Senator Dianne Feinstein
Senator Tom Harkin
Senator Barbara Mikulski
Congressman Berkley Bedell
Congresswoman Nancy Pelosi
Dr. Samuel Broder
Dr. Jan Buckner
Dr. Bruce Chabner
Dr. Daniel Eskinazi
Dr. Jay Greenblatt
Dr. Joseph Jacobs
Dr. Mark Malkin
Ms. Mary McCabe
Dr. David Parkinson
Dr. Mario Sznol
Ms. Dorothy Tisevich
======================================

======================================
1993 (10/26/1993) – SRB to [5]
1993 (10/26/1993) – SRB to [14]
1991 (12/2/1991) – guidelines of the NCI’s Decision Network [5 Pgs.]
1992 (6/4/1992) Burzynski to NCI
1992 (9/1992) – NCI selected MSKCC investigator
1992 (11/11/1992) – Burzynski to Dr. Michael A. Friedman
1993 (2/9/1993) – NCI Mary McCabe site visit
1993 (4/1/1993) –
1993 (4/16/1993) – MSKCC protocol
1993 (4/29/1993) – Burzynski to
to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991
1993 (5/5/1993) – Dr. Michael A. Friedman to Burzynski
1993 (6/9/1993) – Burzynski to
to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991
1993 (7/13/1993) – MSKCC protocol
1993 (7/29/1993) – “Black Holism,” The Village Voice
1993 (8/24/1993) – Burzynski to Dr. Dale Shoemaker
to proceed following the guidelines of the NCI’s Decision Network on 12/2/1991
1993 (8/30/1993) – MSKCC protocol
1993 (10/20/1993) – Dr. Michael A. Friedman to Burzynski
======================================