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

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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
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The article claims:
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Burzynski, 70, calls his drugs “antineoplastons” and says he has given them to more than 8,000 patients since 1977.”
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However, if you select the “8,000 patients” link, the referenced page does NOT indicate that at all [2]
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It advises:
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“That same year, Dr. Burzynski founded his clinic in Houston where he’s since treated over 8,000 patients.” [3]
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Nowhere does it indicate that he “treated 8,000 patients” with antineoplastons
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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 ?
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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]
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The article continues:
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“Individual success stories can be misleading, said Arthur Caplan, a professor and head of the division of bioethics at NYU Langone Medical Center”
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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
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The article quotes Dr. Jan Buckner as saying:
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“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”
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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]
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The article then quotes Peter Adamson, chair of the Children’s Oncology Group:
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“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”
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This is laughable

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

The site posits:
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“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)…”
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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”
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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 !
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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”
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The article posts this ridiculous claim:
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“Yet the National Cancer Institute says there is no evidence that Burzynski has cured a single patient, or even helped one live longer
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That’s NOT what this seems to suggest [8]
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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”:
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“He’s a snake oil salesman,” says pediatric oncologist Peter Adamson, a professor of pediatrics and pharmacology at Children’s Hospital of Philadelphia”
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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]
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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)”
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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 ?
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In regards to the Merritt’s, the article has:
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“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 ?
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The article continues:
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“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
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What Liz Szabo and her friends at USA TODAY fail to let the readers know, is that this only applied to one trial:
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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]
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One trial that is retrospective is CAN-1 Clinical Trial
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CAN-1 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH REFRACTORY MALIGNANCIES

133 patients
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Clinical trial of patients treated by Dr. Burzynski through 2/23/1996
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FDA has indicated it will not accept data generated by this trial since it was not a wholly prospective one
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The article continues in the same vein:
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“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”
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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]
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“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]
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Then Fran Visco, president of the National Breast Cancer Coalition makes an outlandish statement, which is quoted in the article:
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“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?”
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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]
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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 ?
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Estimated Breast Cancer Deaths (Women)-USA
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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%)
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American Cancer Society Cancer Facts & Figures (2002-2013)
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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 ?
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Estimated New Breast Cancer (Women) – USA
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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%)
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American Cancer Society Cancer Facts & Figures (2002-2013)
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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 ?
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Visco, the breast cancer advocate

“I do NOT know why it took YOU so long.”
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The article continues with:
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“Yet hypernatremia is one of antineoplastons’ most common side effects, known to doctors for two decades”
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Yet, “The Skeptics™” refuse to discuss:
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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
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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
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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
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You’ve just been served, INSOLENTLY
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USA TODAY, GONE TOMORROW
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REFERENCES:
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[1] – 11/15/2013 – USA TODAY NEWS, NATION
Doctor accused of selling false hope to families
Liz Szabo, USA TODAY
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http://www.usatoday.com/story/news/nation/2013/11/15/stanislaw-burzynski-cancer-controversy/2994561/
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[2] – Mayo Clinic – 1999 – report: Lisa Merritt
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https://www.documentcloud.org/documents/816819-mayo-clinic-1999-report.html
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[3] – 2012 – former Burzynski web-site screenshots, Pg 3 of 62;
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http://www.circare.org/info/bri/burzynski_fdauntitled_promo_2012.pdf
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[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:
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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/
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[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
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https://stanislawrajmundburzynski.wordpress.com/2013/11/14/tam-2013-tam2013-tam2013-the-amazing-meeting-2013-the-amazing-meeting-httptheamazingmeeting-com-httpwww-theamazingmeeting-com/
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[6] – Phenomenon – Brain Tumour Foundation of Canada
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http://www.braintumour.ca/1649/ask-the-expert-psuedo-progression-gbm
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[7] – Pseudoprogression following chemoradiotherapy for glioblastoma multiforme
Can J Neurol Sci. 2010 Jan;37(1):36-42
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http://www.ncbi.nlm.nih.gov/pubmed/20169771/
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[8] – 9/19/2013 – Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet “fact sheet” :
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https://stanislawrajmundburzynski.wordpress.com/2013/09/19/critiquing-national-cancer-institute-nci-at-the-national-institutes-of-health-nih-cancernet/
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[9] – FDA Orphan Drug Designation
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http://www.burzynskiresearch.com/assets/PressRelease_12022008_BZYR(2).pdf
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[10] – 11/7/2013Pete Cohen chats with Sonali Patil, Ph.D., Research Scientist at The Burzynski Clinic:
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https://stanislawrajmundburzynski.wordpress.com/2013/11/07/pete-cohen-chats-with-sonali-patil-ph-d-research-scientist-at-the-burzynski-clinic/
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[11] – 7/9/2013 – Burzynski: The Original 72 Phase II Clinical Trials:
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https://stanislawrajmundburzynski.wordpress.com/2013/07/09/burzynski-the-original-72-phase-ii-clinical-trials/
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[12] – 8/21/2013 – Critiquing David H. Gorski, MD, PhD, FACS http://www.sciencebasedmedicine.org/editorial-staff/david-h-gorski-md-phd-managing-editor/
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https://stanislawrajmundburzynski.wordpress.com/2013/08/21/critiquing-david-h-gorski-md-phd-facs-www-sciencebasedmedicine-orgeditorial-staffdavid-h-gorski-md-phd-managing-editor/
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[13] – 2003 – pg. 94
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http://www.burzynskiclinic.com/images/stories/Publications/960.pdf
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[14] – 3/1982 – Biometrics 1982; 38: 143-51
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http://www.ncbi.nlm.nih.gov/pubmed/7082756/
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[15] – 11/9/2013Pete Cohen chats with Dr. Stanislaw Burzynski – Interview #2:
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https://stanislawrajmundburzynski.wordpress.com/2013/11/09/pete-cohen-chats-with-dr-stanislaw-burzynski-interwiew-2/
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[16] – AMERICAN CANCER SOCIETY: More Interested In Accumulating Wealth Than Saving Lives
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http://www.wnho.net/acs.pdf
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[17] – 9/11/2013 – National Cancer Institute and American Cancer Society: Criminal Indifference to Cancer Prevention and Conflicts of Interest:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/11/national-cancer-institute-and-american-cancer-society-criminal-indifference-to-cancer-prevention-and-conflicts-of-interest/
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[18] – 11/13/2013 – The War on Cancer (I don’t think it means, what you think it says it means) #Winning?
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https://stanislawrajmundburzynski.wordpress.com/2013/11/13/httpcancer-orgacsgroupscontentepidemiologysurveilancedocumentsdocumentacspc-036845-pdf/
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[19] – 4/24/2013 – Burzynski: HYPERNATREMIA:
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https://stanislawrajmundburzynski.wordpress.com/2013/04/24/burzynski-hypernatremia/
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[20] – 9/1999 – Pediatrics. 1999 Sep;104(3 Pt 1):435-9
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http://www.ncbi.nlm.nih.gov/pubmed/10469766/
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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”
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[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”
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Below is how the “fact sheet” looked before and after the “fact sheet’s” “factual issues” were fixed
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BOLD = changes
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[1] – 10/1995 – CancerNet from the National Cancer Institute

CANCER FACTS

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

National Cancer Institute • National Institutes of Health Department of Health and Human Services
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[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
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[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
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[1] – 10/1995 – Dr. Burzynski has used these compounds to treat patients with various cancers
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[2] – 5/20/2002 – Dr. Burzynski has used antineoplastons to treat patients with a variety of cancers
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[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
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[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
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[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
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[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)
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[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
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[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.”
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[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”
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[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
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[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
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[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)
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[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
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[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
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[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
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[1] – 10/1995 – Because these studies were closed prior to completion, no conclusions can be made about the effectiveness or toxicity of antineoplastons
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[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
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[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
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REFERENCES:
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[1] – Date Last Modified 10/1995
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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
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[2] – This fact sheet was reviewed on 7/13/01

Editorial changes were made on 5/20/02
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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
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[1] – Date Last Modified 10/1995
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[2] – This fact sheet was reviewed on 7/13/2001

Editorial changes were made on 5/20/2002
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[2]
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http://www.emory.edu/KomenEd/PDF/Treatment/Antineoplastons.pdf
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[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)
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https://stanislawrajmundburzynski.wordpress.com/2013/09/18/24-1995-10271995-burzynski-to-dr-richard-klausner-7-pgs/
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[0] – Title 18, Part I, Chapter 47, § 1001
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18 USC § 1001 – Statements or entries generally
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http://www.law.cornell.edu/uscode/text/18/1001
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[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
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https://stanislawrajmundburzynski.wordpress.com/2013/09/17/5-1991-11151991-dr-michael-j-hawkins-to-decision-network/
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[G] – 1991 (12/2/1991) – NCI Decision Network Report on Antineoplastons:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/17/6-1991-12291-nci-decision-network-report-on-antineoplastons/
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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:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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