All’s fair in Drugs and War

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GlaxoSmithKline
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$3 BILLION
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7/2/2012
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(4/1998 – 8/2003)
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United States alleges GSK participated in
preparing
publishing
distributing

misleading medical journal article that misreported that clinical trial of drug demonstrated efficacy in treatment when study failed to demonstrate efficacy
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At same time, United States alleges, GSK didn’t make available data from 2 other studies in which drug also failed to demonstrate efficacy
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(2001 – 2007)
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United States alleges GSK failed to include certain safety data about drug in reports to FDA meant to allow FDA to determine if drug continues to be safe for approved indications and to spot drug safety trends
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missing information included data regarding certain post-marketing studies
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data regarding 2 studies undertaken in response to European regulators’ concerns about safety of drug
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United States alleges GSK stated drug had positive cholesterol profile despite having no well-controlled studies to support that message
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Johnson & Johnson (J&J) and subsidiaries, Janssen Pharmaceuticals Inc. and Scios Inc.
Janssen Pharmaceutica Products, L.P.
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$2.2 BILLION +
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11/4/2013, Monday
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Johnson & Johnson (J&J) and Janssen
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complaint alleges J&J and Janssen were aware drug posed serious health risks, but companies downplayed these risks
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For example, when J&J study of drug showed significant risk of strokes and other adverse events in patients, complaint alleges Janssen combined study data with other studies to make it appear there was lower overall risk of adverse events
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year after J&J received results of 2nd study confirming increased safety risk for patients taking drug, but hadn’t published data, one physician who worked on study cautioned Janssen
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“[a]t this point, so long after [the study] has been completedwe must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”
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complaint alleges Janssen knew patients taking drug had increased risk, but nonetheless promoted drug as “uncompromised by safety concerns
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When Janssen received initial results of studies indicating drug posed same risk as other antipsychotics, complaint alleges company retained outside consultants to re-analyze study results and ultimately published articles stating drug was actually associated with lower risk
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J&J and another of its subsidiaries, Scios Inc.
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8/2001 – FDA approved drug to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity
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approval based on study involving hospitalized patients experiencing severe heart failure who received infusions of drug over average 36-hour period
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complaint alleged Scios had no sound scientific evidence supporting medical necessity of outpatient infusions and misleadingly used small pilot study to encourage serial outpatient use of drug
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Abbott Laboratories Inc.
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$1.5 BILLION
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5/7/2012, Monday
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(2001 – 2006)
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company marketed drug in combination with atypical antipsychotic drugs even after its clinical trials failed to demonstrate adding drug was any more effective than atypical antipsychotic alone for that use
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1999 – forced to discontinue clinical trial of drug due to increased incidence of adverse events, including
somnolence
dehydration
anorexia
experienced by study participants administered drug
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funded 2 studies of use of drug
both failed to meet main goals established for the study
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When 2nd study failed to show statistically significant treatment difference between antipsychotic drugs used in combination with drug and antipsychotic drugs alone, waited nearly 2 years to notify sales force about study results and another 2 years to publish results
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AstraZeneca LP / AstraZeneca Pharmaceuticals LP
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$520 MILLION
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4/27/2010, Tuesday
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engaged doctors to conduct studies on unapproved uses of drug
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recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies doctors in question didn’t conduct
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then used
studies
articles

as basis for promotional messages about unapproved uses of drug
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REFERENCE:
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11/26/2013 – United States Department of Justice (DOJ) versus BIG Pharma: BIG Pharma fought the law, and the law won ?:
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https://stanislawrajmundburzynski.wordpress.com/2013/11/26/united-states-department-of-justice-versus-big-pharma-big-pharma-fought-the-law-and-the-law-won/
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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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