Critiquing: Doctor accused of selling false hope to families (USA TODAY NEWS, NATION, Liz Szabo, USA TODAY)

20131116-002847.jpg
I gave Liz Szabo and USA TODAY the chance to act like a Spike Lee joint and “Do the Right Thing”, the same day their article came out [1]

I gave them the opportunity to prove that their article was a legitimate piece of journalism with some semblance of integrity, and NOT just akin to one of “The Skeptics™ phoned-in “rubber-stamped” yellow journalism hit pieces

Instead, it seems that Liz Szabo and / or USA TODAY decided to act as if they had rolled a Spike Lee joint

I sent an e-mail with 2 editorial corrections, and only one (correcting Lisa Merritt’s comment
link from taking the reader to the 1999 Mayo Clinic report instead of to her comments), was corrected [2]

The 2nd correction which they #FAILED to do, earns them well deserved INSOLENCE
——————————————————————
The article claims:
——————————————————————
Burzynski, 70, calls his drugs “antineoplastons” and says he has given them to more than 8,000 patients since 1977.”
——————————————————————

20131116-004037.jpg
——————————————————————
However, if you select the “8,000 patients” link, the referenced page does NOT indicate that at all [2]
——————————————————————

20131116-064344.jpg
——————————————————————
It advises:
——————————————————————
“That same year, Dr. Burzynski founded his clinic in Houston where he’s since treated over 8,000 patients.” [3]
——————————————————————

20131116-064326.jpg
——————————————————————
Nowhere does it indicate that he “treated 8,000 patients” with antineoplastons
——————————————————————

20131116-064409.jpg
——————————————————————
The question that Liz Szabo and USA TODAY should answer, is:

1. Who is your “fact-checker”, and
2. are they smarter than a 5th grader ?
——————————————————————
In fact, Burzynski’s 2002 Securities and Exchange Commission (SEC) filing advises:

” … 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” [4]
——————————————————————
The article continues:
——————————————————————
“Individual success stories can be misleading, said Arthur Caplan, a professor and head of the division of bioethics at NYU Langone Medical Center”
——————————————————————
The question Arthur Caplan should be asking is:

Why has the United States Food and Drug Administration required Burzynski’s clinical trial patients to fail conventional therapies; such as surgery, chemotherapy, and radiation, BEFORE they are allowed to be treated with antineoplaston therapy ?

If the F.D.A. did NOT impose these restrictions upon Burzynski’s clinical trials, then the question Arthur Caplan raises would be moot
——————————————————————
The article quotes Dr. Jan Buckner as saying:
——————————————————————
“When I hear a story that is way out of the norm, the first question I ask is,

‘OK, is the diagnosis even correct?‘ ”

Buckner said”

“If the diagnosis wasn’t right to start with, it doesn’t matter what the treatment was.”

“Brain tumors are notoriously difficult to diagnose, Buckner says”

“When dealing with rare brain cancer, doctors may disagree about how to interpret imaging results up to 40% of the time”
——————————————————————
I wonder if Dr. Jan Buckner would agree with David Gorski; who is a BREAST cancer oncology specialist, and NOT a BRAIN cancer oncology specialist, who has the presumptiveness to speculate that 3 different medical opinions could have misdiagnosed Tori Moreno in August 1998; who was diagnosed with a very large tumor, about 3 inches in the largest diameter and located in the brain stem, which was too risky for surgery, and about which her parents were told by ALL 3, that Tori’s brain cancer was fatal and, she would die in a few days or at the most, 2-6 weeks, and that there was nothing that could be done, and was finally put on Burzynski’s antineoplaston therapy in October, when she was about 3 ½ months old, and in such condition that they were afraid that she might die at any time, David H. Gorski, M.D., Ph.D., FACS; who claims, “I do know cancer science” , has the audacity, because of his “book learnin'” has the temerity to postulate his “science-based medicine theory” that Miller’s Children at Long Beach Memorial misdiagnosed Tori Moreno’s inoperable stage 4 BSG

David Gorski has the gall to profer that City of Hope misdiagnosed Tori Moreno’s inoperable stage 4 brain stem glioma

David Gorski has the chutzpah to pontificate that Dr. Fred Epstein in New York misdiagnosed Tori Moreno’s inoperable stage IV brainstem glioma [5]
——————————————————————
The article then quotes Peter Adamson, chair of the Children’s Oncology Group:
——————————————————————
“But these therapies may have delayed benefits, taking weeks or months to shrink a tumor

“So patients treated by Burzynski may credit him for their progress, just because he was the last doctor to treat them, says Peter Adamson, chair of the Children’s Oncology Group, an NCI-supported research network that conducts clinical trials in pediatric cancer

Conventional cancer treatment can also cause tumors to swell temporarily, due to inflammation

“A patient who isn’t familiar with this phenomenon may assume her tumor is growing

“When that swelling subsides, patients may assume it’s because of Burzynski, Adamson says”
——————————————————————
This is laughable

In support of this “phenomenon” , the article provides a link to a Canadian web-site [6]

The site posits:
——————————————————————
“RT/TMZ is now widely practiced and the standard of care for appropriately selected patients, we are learning more about the consequences of RT/TMZ”

“One phenomena, termed Pseudo-Progression (psPD)…”
——————————————————————
The problem is that this only applies to “Glioblastoma Multiforme (GBM)”, and the article provides NO proof whatsoever, that any of Burzynski’s “Glioblastoma Multiforme (GBM)” patients have taken “RT/TMZ”
——————————————————————
Additionally, the site cites the reference as:

Sanghera, Perry, Sahgal, et al., “Sunnybrook Health Sciences Odette Cancer Centre” (in press, Canadian Journal of Neuroscience)

(“In press” refers to journal articles which have been accepted for publication, but have not yet been published)

However, the journal article in question was published 1/2010, so it has NOT been “in press” for over 3 years and 7 months [7]

Get your act together, aye, Canada !
——————————————————————
The article rants and raves on and on about FDA inspection reports from as far back as 1998, but at least they did quote Richard A. Jaffe:

“In Burzynski’s defense, Jaffe notes that inspection reports represent preliminary findings

“The FDA has not yet issued final conclusions”
——————————————————————
The article posts this ridiculous claim:
——————————————————————
“Yet the National Cancer Institute says there is no evidence that Burzynski has cured a single patient, or even helped one live longer
——————————————————————
That’s NOT what this seems to suggest [8]
——————————————————————
Then the article quotes pediatric oncologist Peter Adamson, a professor of pediatrics and pharmacology at Children’s Hospital of Philadelphia, in what will no doubt soon be known as a “classic”:
——————————————————————
“He’s a snake oil salesman,” says pediatric oncologist Peter Adamson, a professor of pediatrics and pharmacology at Children’s Hospital of Philadelphia”
——————————————————————
All I’d like to know is, which rock did this clown crawl out from under ?

Dr. Adamson, please advise which “snake oil” has been granted Orphan Drug Designation (“ODD”) from the United States Food and Drug Administration [9], and which “snake oil” has been approved for, and used in, phase III clinical trials ? [10]
——————————————————————
Q: Is it, it the phase 2 trial is finished ?

A: “Mhmm”

Q: but they’re still accepting people ?

A: “Yeah”

Q: on more like a special ?

A: Special basis, and, um, sometimes compassionate grounds

A: “(compassion exception)”

A: “Uh, exceptions

Q: That’s normal ?

A: “Yes”
“So”

A: “(Yes I guess it is a funding issue ?)”

Q: Right

A: “(Like FDA, during the 2nd phase of clinical trials they found the data to be, real, real one, and they gave him the ok to go for 3rd phase of clinical trials, but just to go through this process you would probably need $100,000)”
——————————————————————

20131116-164617.jpg

20131021-200529.jpg

20131021-200553.jpg
——————————————————————
Oh, wait !!

Dr. Adamson, when you say “snake oil”, I take it you are referring to the low-dose chemotherapy that Burzynski uses ?

Dr. Adamson, do you know what a “hack” is ?
——————————————————————
In regards to the Merritt’s, the article has:
——————————————————————
“The couple say that Burzynski misled them about the type of treatment that would be offered, as well as the cost”

My questions about the Merritt’s are:

1. Where is their complaint to the Texas Medical Board ?

2. Where is their lawsuit ? Couldn’t they find an attorney to take their case pro bono ?
——————————————————————
The article continues:
——————————————————————
“Yet even Jaffe has acknowledged that the trialnow in its 17th year — was more about politics than science”

“In his 2008 memoirs, Galileo’s Lawyer, Jaffe called it “a joke.”

“”It was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment,” Jaffe said
——————————————————————
What Liz Szabo and her friends at USA TODAY fail to let the readers know, is that this only applied to one trial:
——————————————————————
Burzynski’s lawyer is obviously referring to the CAN-1 clinical trial mentioned in Burzynski’s 11/25/1997 Securities and Exchange Commission (SEC) filing [11]
——————————————————————
One trial that is retrospective is CAN-1 Clinical Trial
——————————————————————
CAN-1 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH REFRACTORY MALIGNANCIES

133 patients
——————————————————————
Clinical trial of patients treated by Dr. Burzynski through 2/23/1996
——————————————————————
FDA has indicated it will not accept data generated by this trial since it was not a wholly prospective one
——————————————————————
The article continues in the same vein:
——————————————————————
“In an interview, Burzynski said developing new drugs is complex and takes time

“Yet the FDA has approved 108 cancer drugs since Burzynski began his trial”
——————————————————————
Ms. Szabo and “pals” conveniently “forgets” to educate their audience that Burzynski was using Fleming’s One-sample multiple testing procedure for phase II clinical trials [13], which requires that if the 1st 20 patients meet certain criteria, 20 additional patients are added [14]
——————————————————————
“Well, we cannot publish until the time is right” (laughs)

Yeah

“If you would like to publish the results of, of a
10 year survival, for instance”

Mmm

“Which we have
Nobody has over 10 year survival in
malignant brain tumor, but we do, and if you like to do it right, it takes time to prepare it, and that’s what we do now
What we publish so far
We publish numerous, uh, publications which were, interim reports when we are still continuing clinical trials
Now we are preparing, a number of publications for final reports
[15]
——————————————————————
Then Fran Visco, president of the National Breast Cancer Coalition makes an outlandish statement, which is quoted in the article:
——————————————————————
“Fran Visco, president of the National Breast Cancer Coalition, describes the FDA’s tolerance of Burzynski as “outrageous.”

“They have put people at risk for a long time,” says Visco, an attorney and breast cancer survivor

“That’s completely unacceptable”

“How can anyone look at these facts and believe that there is a real clinical trial going on … rather than just using the FDA and the clinical trial system to make money?”
——————————————————————
I have a suggestion for Ms. Visco

Take your hypocrisy and ask the American Cancer Society if they are still engaged in this kind of activity:

1. AMERICAN CANCER SOCIETY: More Interested In Accumulating Wealth Than Saving Lives [15]

2. National Cancer Institute and American Cancer Society: Criminal Indifference to Cancer Prevention and Conflicts of Interest [16]
——————————————————————
Then, ask the American Cancer Society, why is it that 10 years ago, estimated breast cancer deaths were expected to be 39,800 (15%), and this year it was 39,620 (14%), which is ONLY 180 LESS than 10 years ago ?
——————————————————————
Estimated Breast Cancer Deaths (Women)-USA
——————————————————————
2013☝39,620 (14%)
2012👇39,510 (14%)
2011👇39,520 (15%)
2010👇39,840 (15%)
2009👇40,170 (15%)
2008☝40,480 (15%)
2007👇40,460 (15%)
2006☝40,970 (15%)
2005👇40,410 (15%)
2004☝40,110 (15%)
2003☝39,800 (15%)
2002
39,600 (15%)
—————————————————————–
American Cancer Society Cancer Facts & Figures (2002-2013)
—————————————————————–
And then ask the American Cancer Society, why is it that 10 years ago, the estimated NEW breast cancer cases were expected to be 211,300 (32%), and this year it was 232,340 (29%), which is 21,340 MORE than it was 10 years ago ?
——————————————————————
Estimated New Breast Cancer (Women) – USA
——————————————————————
2013☝232,340 (29%)
2012👇226,870 (29%)
2011☝238,480 (30%)
2010☝207,090 (28%)
2009☝192,370 (27%)
2008☝182,460 (26%)

2007👇178,480 (26%)
2006☝212,920 (31%)
2005👇211,240 (32%)
2004☝215,900 (32%)
2003☝211,300 (32%)
2002
_-_203,500 (31%)
—————————————————————–
American Cancer Society Cancer Facts & Figures (2002-2013)
——————————————————————
And after that, ask Susan G. Komen how much is spent on legal action to protect her brand, compared to how much is spent on breast cancer research and prevention ?
——————————————————————
Visco, the breast cancer advocate

“I do NOT know why it took YOU so long.”
——————————————————————
The article continues with:
——————————————————————
“Yet hypernatremia is one of antineoplastons’ most common side effects, known to doctors for two decades”
——————————————————————
Yet, “The Skeptics™” refuse to discuss:
——————————————————————
2/13/2013 – The frequency, cost, and clinical outcomes of hypernatremia in patients hospitalized to a comprehensive cancer center

Over 3 month period in 2006 re 3,446 patients, most of the hypernatremia (90 %) was acquired during hospital stay [19]

Division of Internal Medicine, UT MD Anderson Cancer Center, Houston, TX, USA

Department of General Internal Medicine, University of Texas MD Anderson Cancer Center

Division of Endocrinology, Mayo Clinic
——————————————————————
9/1999 – The changing pattern of hypernatremia in hospitalized children [20]

Department of Pediatrics, Texas Children’s Hospital, Baylor College of Medicine, Houston, Texas, USA
——————————————————————
So, after all that, my question for USA TODAY is, does Liz Szabo, Michael Stravato, Jerry Mosemak or Robert Hanashiro have a
journalism degree ?

Because if any of them do, the institution they obtained it from most be so proud of this piece of “fish wrap” you produced

Thank you, USA TODAY, for censoring my 18 comments

I guess you must be (“intellectual”) cowards

At least Forbes had the GRAPEFRUITS to post some of my comments
——————————————————————
You’ve just been served, INSOLENTLY
——————————————————————
USA TODAY, GONE TOMORROW
——————————————————————

20131116-084820.jpg

20131116-085357.jpg

20131116-084833.jpg

20131116-084847.jpg

20131116-084909.jpg

20131116-084924.jpg

20131116-084937.jpg

20131116-085152.jpg

20131116-085218.jpg

20131116-085311.jpg

20131116-085436.jpg

20131116-085528.jpg

20131116-085550.jpg

20131116-085608.jpg

20131116-085629.jpg

20131116-084804.jpg

20131116-084745.jpg
======================================
REFERENCES:
======================================
[1] – 11/15/2013 – USA TODAY NEWS, NATION
Doctor accused of selling false hope to families
Liz Szabo, USA TODAY
——————————————————————
http://www.usatoday.com/story/news/nation/2013/11/15/stanislaw-burzynski-cancer-controversy/2994561/
======================================
[2] – Mayo Clinic – 1999 – report: Lisa Merritt
——————————————————————
https://www.documentcloud.org/documents/816819-mayo-clinic-1999-report.html
======================================
[3] – 2012 – former Burzynski web-site screenshots, Pg 3 of 62;
——————————————————————

Click to access burzynski_fdauntitled_promo_2012.pdf

======================================
[4] – 4/26/2013 – Burzynski: 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:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-fda-requirements-that-cancer-patients-utilize-more-traditional-cancer-treatment-options-in-order-to-be-eligible-to-participate-in-the-companys-antineoplaston-clinical-trials/
======================================
[5] – 11/14/2013 – Critiquing: Why we fight for patients (Why we fight your patience) TAM 2013, TAM2013, “The Amazing Meeting” 2013 #TAM2013 http://www.theamazingmeeting.com
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/14/tam-2013-tam2013-tam2013-the-amazing-meeting-2013-the-amazing-meeting-httptheamazingmeeting-com-httpwww-theamazingmeeting-com/
======================================
[6] – Phenomenon – Brain Tumour Foundation of Canada
——————————————————————
http://www.braintumour.ca/1649/ask-the-expert-psuedo-progression-gbm
======================================
[7] – Pseudoprogression following chemoradiotherapy for glioblastoma multiforme
Can J Neurol Sci. 2010 Jan;37(1):36-42
——————————————————————
http://www.ncbi.nlm.nih.gov/pubmed/20169771/
======================================
[8] – 9/19/2013 – Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet “fact sheet” :
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/19/critiquing-national-cancer-institute-nci-at-the-national-institutes-of-health-nih-cancernet/
======================================
[9] – FDA Orphan Drug Designation
——————————————————————

Click to access PressRelease_12022008_BZYR(2).pdf

======================================
[10] – 11/7/2013Pete Cohen chats with Sonali Patil, Ph.D., Research Scientist at The Burzynski Clinic:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/07/pete-cohen-chats-with-sonali-patil-ph-d-research-scientist-at-the-burzynski-clinic/
======================================
[11] – 7/9/2013 – Burzynski: The Original 72 Phase II Clinical Trials:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/09/burzynski-the-original-72-phase-ii-clinical-trials/
======================================
[12] – 8/21/2013 – Critiquing David H. Gorski, MD, PhD, FACS http://www.sciencebasedmedicine.org/editorial-staff/david-h-gorski-md-phd-managing-editor/
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/21/critiquing-david-h-gorski-md-phd-facs-www-sciencebasedmedicine-orgeditorial-staffdavid-h-gorski-md-phd-managing-editor/
======================================
[13] – 2003 – pg. 94
——————————————————————

Click to access 960.pdf

======================================
[14] – 3/1982 – Biometrics 1982; 38: 143-51
——————————————————————
http://www.ncbi.nlm.nih.gov/pubmed/7082756/
======================================
[15] – 11/9/2013Pete Cohen chats with Dr. Stanislaw Burzynski – Interview #2:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/09/pete-cohen-chats-with-dr-stanislaw-burzynski-interwiew-2/
======================================
[16] – AMERICAN CANCER SOCIETY: More Interested In Accumulating Wealth Than Saving Lives
——————————————————————

Click to access acs.pdf

======================================
[17] – 9/11/2013 – National Cancer Institute and American Cancer Society: Criminal Indifference to Cancer Prevention and Conflicts of Interest:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/11/national-cancer-institute-and-american-cancer-society-criminal-indifference-to-cancer-prevention-and-conflicts-of-interest/
—————————————————————
[18] – 11/13/2013 – The War on Cancer (I don’t think it means, what you think it says it means) #Winning?
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/13/httpcancer-orgacsgroupscontentepidemiologysurveilancedocumentsdocumentacspc-036845-pdf/
======================================
[19] – 4/24/2013 – Burzynski: HYPERNATREMIA:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/24/burzynski-hypernatremia/
======================================
[20] – 9/1999 – Pediatrics. 1999 Sep;104(3 Pt 1):435-9
——————————————————————
http://www.ncbi.nlm.nih.gov/pubmed/10469766/
======================================

20131116-002912.jpg

Advertisement

“The Amazing Meeting” (I don’t think it means, what you think it says it means): 2 Intellectually and Ethically Challenged Individuals, Twaddle at TAM 2013

Gentlemen, I start your Insolence 😇
——————————————————————
(1:30) [1]
——————————————————————
The “motto” of “The Amazing (Not so Much) Meeting” is “Fighting Fakers,” which is apropos, since I doubt that “Orac” the “Check my Facts” Hack of Dr. David H. Gorski, grasps the irony, that when I read some of his blog articles, you could easily switch his name with the name of some individual he is flogging, and the proverbial shoe fits, and:
——————————————————————
(1:40)
——————————————————————
“This is a guy who sometimes fools even, you know, physicians”
——————————————————————
(I couldn’t have said it better, myself) 😊
——————————————————————
(2:47)
——————————————————————
He states:

“There is a long segment about “The Skeptics”

(applause) 😝
——————————————————————
(4:25)
——————————————————————
“His lawyer wrote a book”

“About a half of it is about Burzynski [4]
——————————————————————
6:00
——————————————————————
Gorski mentions that Burzynski noticed that there were higher levels of these chemicals in healthy people, than people with cancer
——————————————————————
Whereas, Burzynski is on record as having said [5]:

” . . . healthy people have abundance of these chemicals in blood
Cancer patients have varied to none

I did NOT know before now, that GorskGeek thinks that “none” is a “level” 😶
——————————————————————
He continues:

AS2.1 – which is a chemical called phenylacetic acid, which is a byproduct of metabolism that turns into phenylacetylglutamine by the liver

A10 – soluble is basically the same thing
It breaks down to PAG
——————————————————————
WOW !

I thought it was: AS2 1 😊

They are “basically the same thing” ? 😳

What does Burzynski say ? [6]

Phenylacetylglutaminate (PG) and Phenylacetate (PN) are metabolites of Phenylbutyrate (PB) and are constituents of antineoplaston AS2-1

PG and PN are naturally occurring in human body as result of metabolism of phenylalanine in liver and kidneys

formulation of antineoplaston AS2-1 is 4:1 mixture of synthetic PN and PG

A10 is 4:1 mixture of PG and iso-PG

That does NOT look like “basically the same thing” to me 😛

20131111-160455.jpg
——————————————————————
(6:50)
——————————————————————
Gorski founders on:

“And these are substances which were actually studied in the ’50’s and ’60’s and not found to be particularly, um, promising, but, he didn’t know that then”
——————————————————————
GorskGeek has #FAILED miserably to prove that on his blogs [7] 😄
——————————————————————
(8:00)
——————————————————————
Gorski comments about Burzynski’s “animal testing,” “species specific” claims:

“There are ways of getting around that”
——————————————————————
But Gorski, again, has #FAILED miserably to prove it [8] 😅
——————————————————————
(12:00)
——————————————————————
Gorski makes lame excuses about the NCI phase II clinical trial [9] 😖
——————————————————————
(12:50)
——————————————————————
Gorski claims Burzynski was indicted for insurance fraud in the 1997 case 😱
——————————————————————
GorskGeek, care to try and prove that one also ? [10] 😃
——————————————————————
(14:25)
——————————————————————
Gorski then states that out of 61 trials on clinicaltrials . gov, “most” are “closed or unknown”
——————————————————————
GorskGeek #FAILED again 😁

At the time it was:

1 – Not Yet Recruiting
(OPEN)(Phase 3)
1 – COMPLETED
2 – WITHDRAWN
(Withdrawn due to slow enrollment)
7 – WITHDRAWN
(This study has been withdrawn prior to enrollment)
(9=WITHDRAWN)
10 – Recruiting
(10=OPEN)
40 – Active, not recruiting –
(40=CLOSED)
61 =TOTAL
——————————————————————
(15:20)
——————————————————————
Gorski attempts to go all “legal eagle”:

“Listen to Burzynski’s lawyer!”

“You listen to Burzynski’s lawyer; and, and I swear I don’t understand, like why Burzynski would let him, let his lawyer say stuff this damning in his own book, but he does”

“So, get a load of some of these quotes, referring to one of the clinical trials, he says:”

“It was a joke”

“. . . there could not be any possibility of meaningful data coming out of the so-called clinical trial, it was all an artifice, that, you know, designed so that they could continue giving the treatment

“The FDA wanted all of his patients to be on an IND, so, that’s what we did”
——————————————————————
Gorski, attorney Rick Jaffe is an American, living in America NOT the formerly communist Poland

He can say whatever he wants

GorskGeek is NOT a lawyer 😓

And there’s an excellent reason why

Nor is he schooled in the proper usage of the English language

FACT:

” . . . the so-called clinical trial . . .”

Any human being with a modicum of intelligence about the English language, understands that the term “clinical trial” is singular, i.e. one

Burzynski’s lawyer is obviously referring to the CAN-1 clinical trial mentioned in Burzynski’s 11/25/1997 Securities and Exchange Commission (SEC) filing [11]

One trial that is retrospective is CAN-1 Clinical Trial
——————————————————————
CAN-1 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH REFRACTORY MALIGNANCIES

133 patients
——————————————————————
Clinical trial of patients treated by Dr. Burzynski through 2/23/1996

FDA has indicated it will not accept data generated by this trial since it was not a wholly prospective one
——————————————————————
Gorski continues his trend of #FAILURES when he mentions the additional types of treatments that Burzynski was offering, but he #FAILED to mention [12] 😂
——————————————————————
” … 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”
——————————————————————
(18:20)
——————————————————————
Gorski addresses the case of Tori Moreno
——————————————————————
Kim Moreno states:

“We originally were at Miller’s Children at Long Beach Memorial and then went to City of Hope

“We also sent her MRI’s to Dr. Fred Epstein in New York to be looked at”

Gorski suggests that 3 different opinions could have misdiagnosed Tori Moreno

You can read an interview with Tori’s mother [13]
——————————————————————
(19:45)
——————————————————————
Gorski goes on to mention Burzynski patients going to Texas Children’s Hospital with hypernatremia issues
——————————————————————
Gorski, do you mean this ? [14]

The changing pattern of hypernatremia in hospitalized children

Department of Pediatrics, Texas Children’s Hospital, Baylor College of Medicine, Houston, Texas, USA
——————————————————————
(20:00)
——————————————————————
Gorski mangles the case of Hannah Bradley, who had a grade 3 anaplastic astrocytoma brain tumor

GorskGeek makes excuses like “spontaneous remission”, but then provides no citation, reference, or link to a case of such a tumor having spontaneously exhibited remission [15]
——————————————————————
(20:40)
——————————————————————
Gorski states that antineoplastons are chemotherapy
——————————————————————
No, Gorski, antineoplaston are:

“…an unapproved drug, not ordinary “chemotherapy [16] 😣
——————————————————————
(21:53)
——————————————————————
Gorski claims in regard to Burzynski’s personalized gene-targeted therapy:

” . . . gives to the patient without regard for synergistic toxicity

“Boom, there you go”
——————————————————————
Gorski’s #FAIL rate continues, as Burzynski has stated that phase 2 and 3 publications are reviewed as part of this process [17]

Gorski, “BOOM, THERE YOU GO”
——————————————————————
Gorski, you should hire out to the Democratic Party as their mascot, because you must be the biggest pompous ASS I’ve ever seen 😜

Gorski, my advice: don’t quit your day job, HACK 😷
——————————————————————
The #TAM2013 audience then has to suffer through 22:36 of the blatherskite of Robert J. (don’t call me Bobby) “Bob” Blaskiewicz Blatherskitewicz [2]

He blathers about the “dozen,” “17,” “16 dead,” “pancreatic cancer,” “Joseph, who was alive but died well within the life expectancy given his diagnosis,” “Joann, who was alive but died within a year of starting therapy,” “Irene S., who was dead within month,” “Maxine, who was already dead,” the “103 in 2011,” “63 in mid-June,” “17 on original 1999 site,” “about 3 added a year,” the “about 50 stories,” “1/10th of patient names gathered,” “Amelia S. – 7, tumor breaking up,” “Chase,” “Cody – 1994, 20 years ago, 2 visits, 6 weeks treatment breaking up,” “David,” “Janet, 3 – 5 yrs., oncologist, now dead, ovarian cancer,” “Pete took video down,” “8,000 patients,” “probable ischemic necrosis,” “13 yr. old, getting worse getting better, vomited – Marlene, nurse,” “Rory died 2005,” “Supatra, swelling, last wed., brain tumor,” “Side-effect, 2%, sodium load,” “Andrea, U.S. News and World Report, 30% chance recovery, glioblastoma, ANP in luggage, died on plane,” “Cathy wanted to be on ANP, Greg Burzynski, found out only brain tumor,” “Denise D. breast cancer,” and finally:
——————————————————————
(18:45)
——————————————————————
” … and light as many fires under his butt as we can
——————————————————————
Mentions Rick Jaffe’s book Galileo’s Lawyer

IT’S ALL ABOUT THE PATIENTS [4]
——————————————————————
All you need to know about Blaskiewicz is:

“White man speak with forked tongue” [18]
——————————————————————
The 3rd video is a panel discussion, which includes “man-crush” tag-team [3]

Robert Blaskiewicz and David Gorski
——————————————————————
(8:00)
——————————————————————
Bob says:

“Yeah, I’m not that type of doctor
——————————————————————
Bob, the correct answer for you, is:

“I’m NOT a doctor” QUACK
——————————————————————
(13:05)
——————————————————————
Gorski gabs that he’s a:

“Game of Thrones Geek”
——————————————————————
I just knew I was right, GorskGeek [19]
——————————————————————
(14:00)
——————————————————————
The only female panelist mentions “bureaucrats”, “wimps”, and “people without balls”
——————————————————————
2 out of 3 ain’t bad

She describes the Bob and David show to a T
——————————————————————
(15:00)
——————————————————————
The claim is made that a Burzynski physician appeared on the Burzynski Facebook page announcing results
——————————————————————
(16:00)
——————————————————————
Gorski #whines that the Texas Medical Board wasn’t successful in shutting Burzynski down because of “politics”
——————————————————————
LAUGHABLE
——————————————————————
(20:55)
——————————————————————
Gorski gives his usual excuse:

“He’s not an oncologist”
——————————————————————
GorskiGeek, that claim is as dead as apparently, quite a number of your brain cells [15]
——————————————————————
(34:40)
——————————————————————
Audience members are given the opportunity to speak, and this is the garbage served up:
——————————————————————
“Hi, this is Susan

Ah, don’t forget to mention that Wikipedia has been a major battlefield

We’ve had 23,000 views to the clinic’s page this last month, also rebutr . . .”
——————————————————————
“Control the flow of information”
——————————————————————
Gorski pipes up:

“What she said”
——————————————————————
(35:20)
——————————————————————
Blatherskitewicz chimes in:

“When it comes to Wikipedia can I just mention that is, that is, that that is so effective that Wikipedia was singled out in the most recent Burzynski movie
——————————————————————
Gorski chirps:

“Yes”
——————————————————————
Bob yacks:

“as being controlled by evil skeptics
——————————————————————
Gorski ejaculates:

“No, seriously”
——————————————————————
Bob bleats:

“No”

(applause)
——————————————————————
“You have to unleash the evil hoards of skeptics

“Wahahaha” 👿
——————————————————————
Dr. Stanislaw Burzynski on Wikipedia:

“Simply don’t pay attention to it, because it, it’s not true”

“You won’t be able to, do any, clinical research which we do, without convincing evidence, especially when you have the most powerful agency in the government which is against you

“So they would love to find something which is wrong with what we are doing”

“Ah, so the fact that they’ve, um, agreed that what we have has value, and they allow us to do phase 3 clinical trials it means that we are right”

“Because, uh, uh, nobody who didn’t have any, concrete evidence that it works, would be able to go as far”

“So whatever Wikipedia says, well, I don’t care for them

(laughing) [5]
——————————————————————
Enlightening ?

Inspiring ?

Amazing ?

Hypocrites

Apparatchiks [20]
======================================
REFERENCES:
======================================
[1]David Gorski – Why We Fight (Part I): Stanislaw Burzynski Versus Science-Based Medicine – TAM 2013 11/8/2013 (22:44)
——————————————————————

======================================
[2]Robert Blaskiewicz – Why We Fight (Part II): It’s All About The Patients – TAM 2013 11/8/2013 (22:36)
——————————————————————

======================================
[3] – Medical Cranks And Quacks
TAM 2013 JREF
11/8/2013 (42:42)
——————————————————————

======================================
[4]“Galileo’s Lawyer” Richard A. Jaffe, Esq.
——————————————————————
http://www.richardjaffe.com
======================================
[5] – 11/9/2013 – Pete Cohen chats with Dr. Stanislaw Burzynski:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/09/pete-cohen-chats-with-dr-stanislaw-burzynski/
======================================
[6] – 6/2012 – Journal of Cancer Therapy, 2012, 3, 192-200 doi:10.4236/jct.2012.33028 Published Online June 2012, Pg. 192
——————————————————————

Click to access 9219.pdf

======================================
[7]Burzynski: Oh, RATS!!!:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/26/the-lancet-oncology-peer-review-team-d-12-01519-fail-2/
======================================
[8] – Critiquing: How Stanislaw Burzynski became Burzynski the Brave Maverick Doctor, part 1:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/22/critiquing-how-stanislaw-burzynski-became-burzynski-the-brave-maverick-doctor-part-1/
======================================
[9] – 9/19/2013 – 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/
======================================
[10] – 9/25/2013 – Critiquing: National Council Against Health Fraud, Inc. – NCAHF News: JURY NULLIFICATION THWARTS BURZYNSKI CONVICTION:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/25/critiquing-national-council-against-health-fraud-inc-ncahf-news-jury-nullification-thwarts-burzynski-conviction/
======================================
[11] – 7/9/2013 – Burzynski: The Original 72 Phase II Clinical Trials:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/09/burzynski-the-original-72-phase-ii-clinical-trials/
======================================
[12] – 4/26/2013 – Burzynski: 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:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-fda-requirements-that-cancer-patients-utilize-more-traditional-cancer-treatment-options-in-order-to-be-eligible-to-participate-in-the-companys-antineoplaston-clinical-trials/
======================================
[13] – Tori Moreno
——————————————————————
http://www.cancerinform.org/aburzinterview2.html
======================================
[14] – 9/1999 – Pediatrics. 1999 Sep;104(3 Pt 1):435-9
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/10469766/
======================================
[15] – 11/2/2013 – Critiquing: Dr. Stanislaw Burzynski’s cancer “success” stories:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/02/critiquing-dr-stanislaw-burzynskis-cancer-success-stories/
——————————————————————
10/25/2013 – Hannah Bradley – I Feel Empowered, In Control Of My Body: Four Women On Fighting Cancer With Alternative Therapies http://www.telegraph.co.uk/health/10383724/I-feel-empowered-in-control-of-my-body-four-women-on-fighting-cancer-with-alternative-therapies.html
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/25/hannah-bradley-i-feel-empowered-in-control-of-my-body-four-women-on-fighting-cancer-with-alternative-therapies-httpwww-telegraph-co-ukhealth10383724i-feel-empowered-in-control-of-my-body-fo/
======================================
[16] – NOT ORDINARY CHEMOTHERAPY
——————————————————————
https://bulk.resource.org/courts.gov/c/F3/27/27.F3d.153.93-2071.html
======================================
[17] – 9/4/2013 – University of Michigan, where is alum Dr. David H. “Orac” Gorski’s Grapefruits ?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/04/university-of-michigan-where-is-alum-dr-david-h-orac-gorskis-grapefruits/
======================================
[18] – 10/13/2013 – Why “The Skeptics™” Perfessor Robert J. (don’t call me “Bobby”) “Bob” Blaskiewicz (@rjblaskiewicz) of University of Wisconsin, Eau Claire, “Fame,” is a Coward and a Liar:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/13/why-the-skeptics-perfessor-robert-j-dont-call-me-bobby-bob-blaskiewicz-rjblaskiewicz-of-university-of-wisconsin-eau-claire-fame-is-a-coward-and-a-liar/
======================================
[19] – 10/27/2013 – “The Skeptics™” Burzynski Bias, Censorship, Lies, and Alibi’s: September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/27/the-skeptics-lie-lied-lies-liars-lying-burzynski-bias-censorship-lies-and-alibis-september-28-2013-the-skeptics-burzynski-discussion-by-bob-blaskiewic/
======================================
[20] – 11/9/2013 – Wikipedia Articles:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/11/burzynski-timeline/
======================================

“The Skeptics™” Burzynski Bias, Censorship, Lies, and Alibi’s: September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51

——————————————————————
BB – Bob Blaskiewicz
——————————————————————
1:25:14
——————————————————————
BB“Well we do have for for for for one thing, um, I guess to understand is that we are uh motivated by um uh a respect
======================================
Bob, would that include “a respect” for “facts” ?

Because you seem to be the Hillary Clinton of “The Skeptics™”, in that you want people to think of the “children”, yet you also seem to want people to ignore that your “facts” might be “factually-challenged” and tainted by your “bias”
======================================
BB“this is the one thing that that all Skeptics I think um are uh respect critical thinking
======================================
Bob, I am very “critical” in my “thinking” of “The Skeptics™” who indicate that they supposedly want to “debate” and who claim that they will “respond on my blog” because “it only seems fair”, but then do NOT respond

Is THAT the kind of “critical thinking” you are referring to ? [1]
======================================
BB“um, and um respect scientific uh a we we’re mostly scientific enthusiasts
======================================
Bob, would that include Trollolo Mark McAndrew (@MarkMcan) who exhibited what type of “scientific enthusiasts” “The Skeptics™” attract, when he Trollolo’d all over “The Telegraph” ? [2]
======================================
BB“but for the most part we all respect scientific consensus
======================================
Bob, does that include the “scientific consensus” reached by the doctors who decided that Burzynski’s antineoplastons exhibited “antitumor activity” ? [3]
======================================
BB“and we respect scientific method
======================================
Bob, then why does your “The Other Burzynski Patient Group” (TOBPG) blog NOT “respect the scientific method” by indicating if those patients had no prior treatment, biopsy only, surgery, chemotherapy, radiation, or some other treatment, and how long they were on any therapy, if any ?
======================================
BB – “and have an enthusiasm for living in the real world”
======================================
Bob, exactly what “world” are you living in that you adopt lying and deception as part of your agenda regarding Burzynski ?
======================================
BB – “this is something that like all of us us are about”
——————————————————————
1:26:00
——————————————————————
Bob, do you mean what I wrote about above?
======================================
REFERENCES:
======================================
[1] – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/04/september-28-2013-the-skeptics-burzynski-discussion-by-bob-blaskiewicz-21951/
======================================
[2] – “The Skeptics™” Mark McAndrew is Trollolo:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/25/the-skeptics-mark-mcandrew-is-trollolo/
======================================
[3] – 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/
======================================

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

20131021-200529.jpg

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

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

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

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

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

“And it’s always been his burden of proof

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

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

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

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

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

Subpart F–Confidentiality of Information

Sec. 601.50

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

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

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

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

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

Burzynski ?

FDA ?

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

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

“It is Burzynski’s job to be convincing”

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

“In decades”

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

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

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

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

“It’s ultimately Burzynski”

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

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

“That doesn’t”

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

“How long would it take ?”

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

“Years ?”

“How long ?”

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

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

“I can do that”

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

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

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

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

“You’re you’re you’re assuming”

“You’re you’re you’re assuming that”

“You’re assuming that”

“Um, I’m not assuming that”

“There is a correct answer here”

“You don’t know”

“You don’t know”

“You need to look into it”

“Alright ?”

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

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

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

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

“I try to fight against it, constantly”

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

“He withdrew the the phase 3 clinical trial”

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

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

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

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

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

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

“What about the the Public Library of Science?”

“It’s not the only journal there”

“What about BMC Cancer ?”

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

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

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

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

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

So

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

“How long will it take ?”

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

“We can’t find it anywhere”

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

“We can’t find that anywhere”

“We’ve asked”

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

“And, and it hasn’t come to us

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

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

1. Annals of Oncology 2010;21:viii221 ?

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

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

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

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

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

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

“We’re talking about life”

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

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

“This is important stuff”

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

“It’s nothing”

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

“You know”

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

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

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

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

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

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

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

You know, I don’t necessarily agree with that

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

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

“You know”

“They’re just saying, “No thanks””

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

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

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

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

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

“Is that what you’re saying ?”

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

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

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

“I mean you just can’t

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

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

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

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

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

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

“Right ?”

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

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

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

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

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

“Right ?”

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

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

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

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

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

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

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

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

“The FDA’s in control”

“They sign off on these things”

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

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

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

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

“That’s important”

“That that that’s really important

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

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

“And that’s important”

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

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

“Gorski has made it abundantly clear”

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

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

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

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

You know

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

“Send me that”

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

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

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

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

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

Bob, who approves “Accelerated Approval” ?

1. FDA ?

2. A peer-reviewed scientific journal ?

3. The Skeptics™ ?

Bob, It’s your unlucky [13]
======================================
REFERENCES:
======================================
[1] – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/04/september-28-2013-the-skeptics-burzynski-discussion-by-bob-blaskiewicz-21951/
======================================
[2] – FDA grants Orphan Drug Designation (ODD) for A10 and AS2-1:
——————————————————————

Click to access PressRelease_12022008_BZYR(2).pdf

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

Critiquing: Amelia’s family ‘mislead by cancer clinic’

6/5/2013 – This article was published By Getreading [1]

“A family who sent their terminally ill daughter to the US for experimental treatment said the clinic misled them about her chances of survival

“The parents of Pride of Reading Child of Courage winner, four-year-old Amelia Saunders who died in January, say they were told she had a 54 per cent chance of survival with the clinical trial in Houston, Texas

“However mum Chantal Saunders, 36, believes the actual figure was just one per cent
——————————————————————
Based on what ?
——————————————————————
“A BBC Panorama investigation shown on Monday questioned whether the Burzynski Clinic was “selling hope” to families
——————————————————————
Aren’t all cancer treatments “selling hope” ?
——————————————————————
“In it, Mrs Saunders said:”

“I think that’s wrong” [54 per cent figure]

“I think that’s a complete lie”

“I think one per cent is a more accurate figure.”
——————————————————————
Based on what ?
——————————————————————
“Dad Richard, 35, says he has only found two patients of Dr Stanislaw Burzynski with the same rare brain tumour as Amelia who survived long-term”

“Mr Saunders, from Lower Earley, said:”

“It didn’t work for Amelia but we absolutely know it works for other people.”

“It’s hard to believe it works for Amelia’s tumour type and that’s what we have found tricky”

“I’ve had all sorts of excuses from them as to why they won’t release data on how many patients they treat and the outcomes”

“I think the figures Panorama were given show there was 700-odd patients they treated and something like 15 per cent survived over five years
——————————————————————
Panorama’s figures were:

“They say 776 patients with brain tumours were treated in trials before 2008.”

“And that 15.5% had survived more than five years, which compares favourably to other treatments.” [2]
——————————————————————
“If you look at all brain tumours that’s almost identical to any other treatment”
——————————————————————
Based on what ?
——————————————————————
“If you look at Amelia’s tumour alone you’re looking at almost zero per cent.”

Amelia was diagnosed with a rare tumour on her brain stem in February last year

“Her devastated family was told by doctors there was no treatment available in Britain”

“After finding out about Burzynski’s clinical trial, which has been running for 20 years, Amelia’s family decided to raise the money needed for the ‘antineoplaston’ treatment – a staggering £250,000 – in just a few weeks through donations”

Mrs Saunders, who also has two-year-old daughter Charlotte, said:”

“He was giving us more hope than I think realistically there was”
——————————————————————
Based on what ?
——————————————————————
Mr Saunders added:”

“We find it very hard to believe the treatment did nothing”

“We did no chemotherapy with her”

“To keep it stable for 11 months is incredible in itself, but how do we prove that?”

“We can’t.”
——————————————————————
Why not ?

Were there not scans ?
——————————————————————
“In November last year Dr Burzynski told the family a new scan showed Amelia’s tumour was breaking down

UK doctors at Great Ormond Street Hospital in London said it actually showed the tumour was continuing to grow
——————————————————————
Based on what ?

Great Ormond Street Hospital having 36 years of experience treating patients with antineoplastons ?
——————————————————————
“The family decided to stop the Burzynski treatment a few weeks later”
——————————————————————
Based on what ?
——————————————————————
“Although the family now has doubts over Burzynski’s success rate, Richard says they have spoken to others who have been helped by the drug”
——————————————————————
“The family now has doubts over Burzynski’s success rate” ?

What was all this, then ?

a) “A family who sent their terminally ill daughter to the US for experimental treatment said the clinic misled them about her chances of survival

b) “However mum Chantal Saunders, 36, believes the actual figure was just one per cent

c) “I think that’s wrong” [54 per cent figure]

“I think that’s a complete lie”

d) “I think one per cent is a more accurate figure.”

e) “He was giving us more hope than I think realistically there was”
——————————————————————
“He said:”

“We asked repeatedly throughout the time Amelia was under treatment for evidence to back up his claims, and he at no point produced this”

“We found patients ourselves through Facebook, forums, email and word of mouth”

“We want everyone to know that there are people who are living proof that the treatment works – but it just didn’t for our little girl”

“We just wish Dr Burzynski would speak the truth, and release proper, tangible results.”
——————————————————————
So, you wanted him to “release proper, tangible results” before the clinical trials were finished ?
——————————————————————
“The Saunders family have donated the rest of the money raised for Amelia to cancer research and other charities”

“This included £50,000 to a cancer treatment research team at the University of Nottingham

“Its Professor Richard Grundy said it was “unethical” for Dr Burzynski not to publish results from his trial
——————————————————————
So, you wanted him to “publish results from his trial” before the clinical trial was finished ?
——————————————————————
“Unfortunately the results from Dr Burzynski’s clinic are not published in any form that’s acceptable to the scientific community,” he said”
——————————————————————
So a donation of £50,000 was made, which included to a cancer treatment research team at the University of Nottingham, where Professor Richard Grundy; who exhibits NO knowledge of antineoplastons in this article, is

How “convenient” for him and the University

In my opinion,’ it is “unethical” for Professor Grundy to NOT share his findings re Dr. Burzynski’s 2003-2010 phase 2 clinical trial preliminary reports [3]

He reminds of the situation that Burzynski found himself in when he relates that clinical investigators decided to change the protocol without his approval on a clinical trial of antineoplastons

Seriously, who in their right mind would ignore the input of the inventor and developer of a medicine with close to 20 years of clinical experience, and think they know more than that person ? [4]
======================================
REFERENCES:
======================================
[1] – Reading Post, Amelia’s family ‘mislead by cancer clinic’, By Getreading | 5 Jun 2013 07:59
——————————————————————
http://www.getreading.co.uk/news/amelia-saunders-family-mislead-burzynski-4051287
======================================
[2] – 8/4/2013 – Critiquing Dr David H. “Orac” Gorski, M.D., Ph.D, LIAR: Stanislaw Burzynski versus the BBC:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/04/critiquing-dr-david-h-orac-gorski-m-d-ph-d-liar-stanislaw-burzynski-versus-the-bbc/
======================================
[3] – 9/22/2013 – Critiquing Wikipedia: Burzynski Clinic – 2013 BBC documentary, Curing cancer or ‘selling hope’ to the vulnerable?;
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/22/critiquing-wikipedia-burzynski-clinic-2013-bbc-documentary-curing-cancer-or-selling-hope-to-the-vulnerable/
======================================
[4] – 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/
======================================

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

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

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

“Americans love a winner”

“Americans will not tolerate a loser”

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

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

He’s the epitome of the word “loser”

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

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

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

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

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

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

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

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

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

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

It’s a general problem

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

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

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

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

“However, your letter conspicuously fails to address them

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

Pg. 2

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

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

20130920-220216.jpg

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

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

“which genes are targeted by antineoplastons“?

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

Volume 5 Issue 4 October 2003

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

Volume 9 Issue 4 October 2007

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

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

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

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

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

Volume 10 Issue 5 October 2008

Affymetrix Human Genome

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

ORC1L and CDC6

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

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

MAD2L1, BUB1 and CDC20

p21, p53, and GADD45A

p21/CDKN1A, and PPM1A

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

Volume 10 Issue 6 December 2008

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

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

A total human gene array screen using the Affymetrix Human Genome

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

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

Volume 12 Supplement 4 November 2010

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

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

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

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

Using the total human microarray screen (Affymetrix)

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

Volume 14 Supplement 3 September 2012

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

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

AKT2

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

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

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

What did you do, Gorski ?

Phone It in again ?
======================================
REFERENCES:
======================================
[1] – 9/19/2013 – The Institute of Medicine report on cancer care: Is the system “in crisis” ?
——————————————————————
http://scienceblogs.com/insolence/2013/09/19/the-institute-of-medicine-report-on-cancer-care-is-the-system-in-crisis/
======================================
[2] – 1997 – Critiquing: Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/26/x/
======================================
[3] – Critiquing: Dr. David H. “Orac” Gorski and The Skeptics™
http://www.scienceblogs.com/Insolence
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/08/critiquing-dr-david-h-orac-gorski-and-the-skeptics/
======================================
[4] – Critiquing: Dr. David H. “Orac” Gorski, M.D., Ph.D, L.I.A.R.:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/07/critiquing-dr-david-h-orac-gorski-m-d-ph-d-l-i-a-r/
======================================
[5] – 9/19/2013 – Another case of the failure of physician regulation endangering patients
——————————————————————
http://scienceblogs.com/insolence/2013/09/19/another-case-of-the-failure-of-physician-regulation-endangering-patients/
======================================
[6] – Critiquing: Dr. Michael A. Friedman, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
======================================
DID Dr. Michael A. Friedman FIB?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/18/did-dr-michael-a-friedman-fib/
======================================
Dr. Michael A. Friedman, DATA ?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/19/dr-michael-a-friedman-data/
======================================
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
——————————————————————

Click to access 971.pdf

======================================
[12] – 10/2007
——————————————————————

Click to access 5169.pdf

======================================
[13] – 2008
——————————————————————

Click to access 7854.pdf

======================================
[14] – 2008
——————————————————————

Click to access 7897.pdf

======================================
[15] – 11/2010
——————————————————————

Click to access 8636.pdf

======================================
[16] – 6/2012
——————————————————————

Click to access 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
——————————————————————

Click to access 9291.pdf

======================================
http://www.burzynskiclinic.com/scientific-publications.html
======================================
[18] – Wayne State University, Detroit, Michigan, quickly realized that David H. Gorski, MD, PhD, FACS is NOT doing something wrong when he LIES about Burzynski:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/27/wayne-state-university-detroit-michigan-quickly-realized-that-david-h-gorski-md-phd-facs-is-not-doing-something-wrong-when-he-lies-about-burzynski/
======================================

Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet “fact sheet”

[1] – 1995 (10/1995) – The National Cancer Institute (NCI) at the National Institutes of Health (NIH) issued its CancerNet “fact sheet”

The problem is that there were “factual issues” with the CancerNet “fact sheet”
——————————————————————
[0] – All Americans are “presumed to know the law:”

Title 18, Part I, Chapter 47, § 1001

18 USC § 1001 – Statements or entries generally

(3) “makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry”
——————————————————————
Below is how the “fact sheet” looked before and after the “fact sheet’s” “factual issues” were fixed
======================================
BOLD = changes
======================================
[1] – 10/1995 – CancerNet from the National Cancer Institute

CANCER FACTS

National Cancer Institute
National Institutes of Health
——————————————————————
[2] – 5/20/2002 – CANCER FACTS

National Cancer Institute • National Institutes of Health Department of Health and Human Services
======================================
[1] – 10/1995 – National Cancer Institute-Sponsored Clinical Trials of Antineoplastons

Antineoplastons are a group of compounds originally isolated from urine by Dr. Stanislaw Burzynski, who claims that they inhibit cancer cell growth
——————————————————————
[2] – 5/20/2002 – Antineoplastons

Antineoplastons are a group of synthetic compounds that were originally isolated from human blood and urine by Stanislaw Burzynski, M.D., Ph.D., in Houston, Texas
======================================
[1] – 10/1995 – Dr. Burzynski has used these compounds to treat patients with various cancers
——————————————————————
[2] – 5/20/2002 – Dr. Burzynski has used antineoplastons to treat patients with a variety of cancers
======================================
[1] – 10/1995 – In 1991, a “best case series” review was conducted by the National Cancer Institute (NCI) to evaluate clinical responses in a group of patients treated at Dr. Burzynski’s Houston facility
——————————————————————
[2] – 5/20/2002 – In 1991, the National Cancer Institute (NCI) conducted a review to evaluate the clinical responses in a group of patients treated with antineoplastons at the Burzynski Research Institute in Houston
======================================
[1] – 10/1995 – For this review, Dr. Burzynski selected from his entire clinical experience seven brain tumor patients whom he felt had a beneficial effect from antineoplastons
——————————————————————
[2] – 5/20/2002 – The medical records of seven brain tumor patients who were thought to have benefited from treatment with antineoplastons were reviewed by NCI
——————————————————————
[3] – 10/27/1995 – Burzynski objected to [1] in a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH), on page 1:

[A] – Gives the reader the impression that in his entire clinical experience he had only 7 patients who benefitted from antineoplaston treatment

[B] – He prepared not 7, but dozens of cases for the NCI reviewers

[C] – The reviewers were able to spend just one day at the clinic–enough time to review only 7 cases

(averaging one case per hour)
======================================
[1] – 10/1995 – This series did not constitute a formal clinical trial, since it was a retrospective review of medical records, did not include all available patient information, and included only cases selected by Dr. Burzynski
——————————————————————
[2] – 5/20/2002 – This did not constitute a clinical trial but, rather, was a retrospective review of medical records, called a “best case series.”
——————————————————————
[3] – 10/27/1995 – Burzynski objected to [1] in a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH), on page 1:

[D] – The patient medical records that NCI scientists reviewed were exhaustive and did contain “all available patient information.”

[E] – Michael Hawkins, M.D., leader of the site visit team, specifically complimented him on how complete and well-organized they were

[F] – 1991 (11/15/1991) – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services (HHS), Public Health Service, National Institutes of Health (NIH), National Cancer Institute (NCI) sent a 1 page Memorandum Re:
Antineoplaston
to Decision Network:, which advised, in part:

“Seven patient cases were presented at the site visit and the records, pathology slides and scans documenting response were reviewed”
======================================
[1] – 10/1995 – The reviewers of this series determined that there was presumptive evidence of antitumor activity and NCI then proposed that Phase II clinical trials be conducted to evaluate more definitively the response rate and toxicity of antineoplastons in adult patients with refractory brain tumors
——————————————————————
[2] – 5/20/2002 – The reviewers of this series found evidence of antitumor activity, and NCI proposed that formal clinical trials be conducted to further evaluate the response rate and toxicity of antineoplastons in adults with advanced brain tumors
——————————————————————
[F] – 1991 (11/15/1991) – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services (HHS), Public Health Service, National Institutes of Health (NIH), National Cancer Institute (NCI)
sent a 1 page Memorandum Re:
Antineoplaston
to Decision Network:, which advised, in part:

“It was the opinion of the site visit team that antitumor activity was documented in this best case series and that the conduct of Phase II trials was indicated to determine the response rate”

[3] – 10/27/1995 – Burzynski objected to [1] in a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH), on page 1:

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

Their report stated:

“The site visit team determined that antitumor activity was documented in the best case series and that the conduct of Phase II trials was indicated to determine the response rate

(minutes of Decision Network committee meeting)
======================================
[1] – 10/1995 – The decision by NCI to sponsor the study of an agent in a clinical trial does not indicate that the agent is or will be useful in the treatment of cancer patients, only that it merits further evaluation in a research setting

Efforts to study antineoplastons in a scientifically rigorous manner have required complex interactions among NCI, clinical investigators, the National Institutes of Health’s (NIH) Office of Alternative Medicine, the Food and Drug Administration, advocates from the alternative medicine community, and Dr. Burzynski
======================================
[1] – 10/1995 – Two protocols were developed by the participating Cancer Center investigators with extensive review and input from NCI and Dr. Burzynski
——————————————————————
[2] – 5/20/2002 – Investigators at several cancer centers developed protocols for two phase II clinical trials with review and input from NCI and Dr. Burzynski
======================================
[1] – 10/1995 – These studies began in 1993 at Memorial Sloan-Kettering Cancer Center, Mayo Clinic, and the NIH Clinical Center
——————————————————————
[2] – 5/20/2002 – These NCI-sponsored studies began in 1993 at the Memorial Sloan-Kettering Cancer Center, the Mayo Clinic, and the Warren Grant Magnuson Clinical Center at the National Institutes of Health
======================================
[1] – 10/1995 – However, accrual to these studies was very slow and only nine patients were enrolled
——————————————————————
[2] – 5/20/2002 – Patient enrollment in these studies was slow, and by August 1995 only nine patients had entered the trials
======================================
[1] – 10/1995 – On 8/18/1995, the studies were closed because a consensus could not be reached with Dr. Burzynski on the proposed changes in the protocol to increase accrual, and there was no hope of completing the studies in a timely manner
——————————————————————
[2] – 5/20/2002 – Attempts to reach a consensus on proposed changes to increase accrual could not be reached by Dr. Burzynski , NCI staff, and investigators, and on 8/18/1995, the studies were closed prior to completion
——————————————————————
[3] – 10/27/1995 – Burzynski objected to [1] in a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH), on page 1:

[H] – The only reason the clinical trials of antineoplastons were stopped is that NCI would not conduct them as per our written agreement

[I] – Even the NCI’s own previous “fact sheet” on antineoplastons, dated 2/17/1994, states that

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

[J] – The NCI never made any effort to “reach a consensus.”

[K] – It simply violated the written protocol we had agreed upon

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

[M] – When I found out and insisted that NCI either conduct the study as agreed or inform patients that I felt it was conducting the study improperly, NCI cancelled it
======================================
[1] – 10/1995 – Because these studies were closed prior to completion, no conclusions can be made about the effectiveness or toxicity of antineoplastons
——————————————————————
[2] – 5/20/2002 – Because of the small number of patients in these trials, no definitive conclusions can be drawn about the effectiveness of treatment with antineoplastons
======================================
[1] – 10/1995 – It is rare that this kind of NCI-sponsored clinical study cannot be successfully completed

The NCI is disappointed by this outcome but is continuing to evaluate related compounds in clinical trials in order to determine if they may be of benefit in the treatment of patients with cancer
======================================
REFERENCES:
======================================
[1] – Date Last Modified 10/1995
——————————————————————
CancerNet from the National Cancer Institute

CANCER FACTS

National Cancer Institute
National Institutes of Health

National Cancer Institute-Sponsored Clinical Trials of Antineoplastons

Antineoplastons are a group of compounds originally isolated from urine by Dr. Stanislaw Burzynski, who claims that they inhibit cancer cell growth

Dr. Burzynski has used these compounds to treat patients with various cancers

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

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

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

The reviewers of this series determined that there was presumptive evidence of antitumor activity and NCI then proposed that Phase II clinical trials be conducted to evaluate more definitively the response rate and toxicity of antineoplastons in adult patients with refractory brain tumors

The decision by NCI to sponsor the study of an agent in a clinical trial does not indicate that the agent is or will be useful in the treatment of cancer patients, only that it merits further evaluation in a research setting

Efforts to study antineoplastons in a scientifically rigorous manner have required complex interactions among NCI, clinical investigators, the National Institutes of Health’s (NIH) Office of Alternative Medicine, the Food and Drug Administration, advocates from the alternative medicine community, and Dr. Burzynski

Two protocols were developed by the participating Cancer Center investigators with extensive review and input from NCI and Dr. Burzynski

These studies began in 1993 at Memorial Sloan-Kettering Cancer Center, Mayo Clinic, and the NIH Clinical Center

However, accrual to these studies was very slow and only nine patients were enrolled

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

Because these studies were closed prior to completion, no conclusions can be made about the effectiveness or toxicity of antineoplastons

It is rare that this kind of NCI-sponsored clinical study cannot be successfully completed

The NCI is disappointed by this outcome but is continuing to evaluate related compounds in clinical trials in order to determine if they may be of benefit in the treatment of patients with cancer
======================================
[2] – This fact sheet was reviewed on 7/13/01

Editorial changes were made on 5/20/02
——————————————————————
CANCER FACTS

National Cancer Institute • National Institutes of Health Department of Health and Human Services

Antineoplastons

Antineoplastons are a group of synthetic compounds that were originally isolated from human blood and urine by Stanislaw Burzynski, M.D., Ph.D., in Houston, Texas

Dr. Burzynski has used antineoplastons to treat patients with a variety of cancers

In 1991, the National Cancer Institute (NCI) conducted a review to evaluate the clinical responses in a group of patients treated with antineoplastons at the Burzynski Research Institute in Houston

The medical records of seven brain tumor patients who were thought to have benefited from treatment with antineoplastons were reviewed by NCI

This did not constitute a clinical trial but, rather, was a retrospective review of medical records, called a “best case series.”

The reviewers of this series found evidence of antitumor activity, and NCI proposed that formal clinical trials be conducted to further evaluate the response rate and toxicity of antineoplastons in adults with advanced brain tumors

Investigators at several cancer centers developed protocols for two phase II clinical trials with review and input from NCI and Dr. Burzynski

These NCI-sponsored studies began in 1993 at the Memorial Sloan-Kettering Cancer Center, the Mayo Clinic, and the Warren Grant Magnuson Clinical Center at the National Institutes of Health

Patient enrollment in these studies was slow, and by August 1995 only nine patients had entered the trials

Attempts to reach a consensus on proposed changes to increase accrual could not be reached by Dr. Burzynski , NCI staff, and investigators, and on 8/18/1995, the studies were closed prior to completion

A paper describing this research, “Phase II Study of Antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in Patients With Recurrent Glioma,” appears in Mayo Clinic Proceedings 1999, 74:137–145

Because of the small number of patients in these trials, no definitive conclusions can be drawn about the effectiveness of treatment with antineoplastons

At present, the Burzynski Research Institute is conducting trials using antineoplastons for a variety of cancers
======================================
[1] – Date Last Modified 10/1995
——————————————————————

20130919-152521.jpg

20130919-152702.jpg
======================================
[2] – This fact sheet was reviewed on 7/13/2001

Editorial changes were made on 5/20/2002
——————————————————————

20130919-174650.jpg

20130919-174914.jpg
——————————————————————
[2]
——————————————————————

Click to access Antineoplastons.pdf

======================================
[3] – 10/27/1995 – Burzynski sent a 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH)
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/18/24-1995-10271995-burzynski-to-dr-richard-klausner-7-pgs/
======================================
[0] – Title 18, Part I, Chapter 47, § 1001
——————————————————————
18 USC § 1001 – Statements or entries generally
——————————————————————
http://www.law.cornell.edu/uscode/text/18/1001
======================================
[F] – 1991 (11/15/1991) – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services (HHS), Public Health Service, National Institutes of Health (NIH), National Cancer Institute (NCI) sent a 1 page Memorandum Re:
Antineoplaston
to Decision Network
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/17/5-1991-11151991-dr-michael-j-hawkins-to-decision-network/
======================================
[G] – 1991 (12/2/1991) – NCI Decision Network Report on Antineoplastons:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/17/6-1991-12291-nci-decision-network-report-on-antineoplastons/
======================================
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/
======================================