Burzynski: Responses to January 7th to March 15th, 2013 (FDA-483) Inspectional Observations (20 pages)

FDA 483 inspection observations, as redacted by the FDA, which are based on recent inspections and the corresponding responses to those FDA 483 observations
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Responses to January 7th to March 15th, 2013 (FDA-483) Inspectional Observations (20 pages)
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Burzynski_Clinic_redacted_483_response.pdf
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Click to access Burzynski_Clinic_redacted_483_response.pdf

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http://www.burzynskiclinic.com/
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Advertisement

Burzynski: obviously we knew that the FDA inspectors will always find something wrong

“Of course, in order to be, eh, in, eh, in order to do what I was doing, it was necessary for me to have inspection, by the inspectors, approved by the FDA, who check our manufacturing facility, and, ah, certify that what ever we do, we do right, and there are no discrepancies”

“So this was obviously something, very difficult, because obviously we knew that the FDA inspectors will always find something wrong, you know”
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12/2011 – Pete Cohen chats with Dr. Stanislaw Burzynski
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https://stanislawrajmundburzynski.wordpress.com/2013/11/09/pete-cohen-chats-with-dr-stanislaw-burzynski/
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All’s fair in Drugs and War

======================================
GlaxoSmithKline
======================================
$3 BILLION
——————————————————————
7/2/2012
——————————————————————
(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
——————————————————————
At same time, United States alleges, GSK didn’t make available data from 2 other studies in which drug also failed to demonstrate efficacy
——————————————————————
(2001 – 2007)
——————————————————————
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
——————————————————————
missing information included data regarding certain post-marketing studies
——————————————————————
data regarding 2 studies undertaken in response to European regulators’ concerns about safety of drug
——————————————————————
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 +
——————————————————————
11/4/2013, Monday
——————————————————————
Johnson & Johnson (J&J) and Janssen
——————————————————————
complaint alleges J&J and Janssen were aware drug posed serious health risks, but companies downplayed these risks
——————————————————————
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
——————————————————————
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
——————————————————————
“[a]t this point, so long after [the study] has been completed … we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”
——————————————————————
complaint alleges Janssen knew patients taking drug had increased risk, but nonetheless promoted drug as “uncompromised by safety concerns”
——————————————————————
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.
——————————————————————
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
——————————————————————
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
——————————————————————
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
——————————————————————
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
——————————————————————
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
——————————————————————
4/27/2010, Tuesday
——————————————————————
engaged doctors to conduct studies on unapproved uses of drug
——————————————————————
recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies doctors in question didn’t conduct
——————————————————————
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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Marsha Bauman Shaw, your “15 seconds of Fame” about your Burzynski “allegations” on USA TODAY’s Facebook comments page, starts NOW

Marsha Bauman Shaw “claims” on USA TODAY’s “Doctor accused of selling false hope to families” article’s Facebook comments, that she worked for Burzynski 17 years ago (1996):

“I know first hand fraud perpetrated when he was being investigated by the FDA and taken to court while I worked there”

Marsha
Marsha
Marsha

I do NOT find your name anywhere, associated with testifying for the U.S. Gubment in Burzynski’s 1997 criminal case

Is that because you’re no Edward Snowden, and so you put your “money-making concern” before your concern for your country ?

Marsha
Marsha
Marsha

Your “15 seconds of Fame” starts NOW

Critiquing: Eric Merola and Stanislaw Burzynski respond to the FDA findings and the USA TODAY story. Hilarity ensues

GorskiGeek starts off his soapbox stump speech:
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“I was very pleased last Friday, very pleased indeed”
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Of course he was

After all, it was as if USA TODAY was quoting directly from “The Skeptics™” fave Fahrvergnügen pharyngula and GorskGeeks’s jacked July jabberwocky at “The Amazing Meeting” 2013 (TAM 2013 #TAM2013) Twitter Twaddle-fest

Given the normal subject matter of this blog, in which I face a seemingly unrelenting infiltration of pseudononsense pseudononscience and hackery into even the most hallowed halls of hacademic medicine, against which I seem to be fighting a mostly uphill battle, having an opportunity to see such an excellent non-deconstruction of science and medicine in a large bad mainstream news outlet like USA TODAY, GONE TOMORROW is rare and ungratifying

GorskGeek gambits:
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“As you might recall, USA TODAY reporter Liz Szabo capped off a months-long investigation of Dr. Stanislaw Burzynski and his Burzynski Clinic with an excellent (and surprisingly long and detailed) report, complete with sidebars explaining why cancer experts don’t think that Burzysnki’s anecdotes are compelling evidence that his treatment, antineoplastons, has significant anticancer activity and a human interest story about patients whom Burzynski took to the cleaners”
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My question ?

GorskGeek, how do you know it was a:

“months-long investigation” ?

The article does NOT indicate HOW LONG the USA TODAY “investigation” took

From this, I can only conclude, as I did after 1st reading the article, that based on the comments of Dr. David H. Gorski “Orac”, that there must have been collusion between “The Skeptics™” and USA TODAY

Most of this, of course, is no news to my readers, as I’ve been writing about Dr. Burzynski on a fairly regular basis for over 8 months now
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GorskGeek goofs:
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“It’s just amazing to see it all boiled down into three articles and ten short videos in the way that Szabo and USA TODAY did, to be read by millions, instead of the thousands who read this blog“
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Thousands read his blog ?

Does he mean over the 2 year period he’s been writing about Burzynski ?

GorskGeek Inspector Gadgets:
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“Szabo also found out who the child was who died of hypernatremia due to antineoplastons in June 2012, a death that precipitated the partial clinical hold on Burzynski’s bogus clinical trials, about which both Liz Szabo and I have quoted Burzynski’s own lawyer, Richard Jaffe, from his memoir, first about Burzynski’s “wastebasket” trial, CAN-1“
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GorskGeek and USA TODAY both hashtag Failed to point out that a boy, the same age as Josia Cotto, survived a serum sodium (Na+) level of 234 mEq/L

If GorskGeek actually knew how to do real “science-based medicine” research, and if Liz Szabo and Jerry Mosemak had really actually done a “months-long investigation”, maybe USA TODAY and “Orac” could have had enough time to have figured the above out, as well as the clinical trial Burzynski’s attorney, Rick Jaffe, was referring to, was the CAN-1, which even you did NOT display any knowledge of in the July
TAMmany Twaddle [3], and your 11/15/2013 article [4]
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Naturally, upon reading Liz Szabo’s “ story,” I wondered how long it would be before there would be a response from GorskGeek or his minions

Both responses contain the same sorts of tropes, misinformation, and pseudononscience that I’ve come to expect from GorskGeek [1-2+4]

USA TODAY is biased and in the pocket of “The Skeptics™”

It was a “Shite Muslim Militia” piece
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GorskGeek dreamsicles:
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“I’ve deconstructed these, and many more, of Merola’s nonsense over the last two years”

“Odd how @BurzynskiMovie pretends I haven’t deconstructed his “evidence” in depth before”?

Really ?

GorskGeek is so much a monumental myopic Mythomaniac

GorskGeek all you did was “cherry-pick” what you wanted to blather about, and selectively ignored everything else
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What actually surprised me was the viscousness of the counterhackattack

For example, in counterhackattacking Eric Merola’s letter to Liz Szabo, GorskGeek tries unsuccessfully to claim that Merola actually hopes that her child will get cancer, so that Burzynski supporters can gloat about it and Szabo will have to apologize to her children for her “perfidy” (in GorskGeek’s eyes, at least):
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GorskGeek gesticulates:
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“He denies that he hopes Szabo’s children will develop brain cancer, but then gloats gleefully over the possibility that she would have to face them after having—again in his mind—”helped to destroy the only thing that could have helped” them”
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In the dictionary, under the definition of “spin bowel movement (SBM),” there should be a picture of “Dr.” (and I use that term very “loosely”) David Gorski

GorskGeek would have fit in holistically as the propagandist for Hitler, Lenin, Mussolini, Pol Pot, Stalin, etc.

Then, just when I thought GorskGeek couldn’t go any lower, he does, this time in his longer response on his blog
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“Eric Merola and Stanislaw Burzynski respond to the FDA findings and the USA TODAY story. Hilarity ensues”
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Obviously, to “Orac” asking GorskGeek to follow normal rules regulating medical ethics and human subject protections in critical trolls’ blog trials is exactly like murdering millions of people’s brain cells, carrying out horrible medical experimentation on common sense and sensibility, making untold numbers of Africans, slaves to his stupendousmess, and harassing, gratuitously, families of soldiers “killed” by his word salad battle

Didn’t anyone ever teach GorskGeek that you need to build up to that sort of climax ?

Of course, the big difference between Hitler’s propaganda chief Joseph Goebbels, unfortunately, is that compared to “Orac,” he had talent, and David GorskGeek does NOT

GorskGeek is a hack and is only funny by accident because he has no filters that tell him when he’s going way under the top

To him, Burzynski is an infidel

I do not share his belief, but, even worse, I have the temerity to criticize his god “Orac,” or, to mix metaphors shamelessly, to point out that GorskGeek has no clothes

Since I’ve dealt with so many of the tropes included in GorskGeek’s not-so-little rant, I hardly see the need to repeat myself

However, as a breast cancer surgeon’s skeptic, I find one of GorskGeek’s lies to be as despicable, or perhaps more so, than his ad hominem comparisons
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GorskGeek, the Hitler of hipocracy, came up with this hit parade of paranoia and “conspiracy theory”:
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“I don’t know what sort of attacks on the UK bloggers who produce the bulk of the skeptical blog posts about Burzynski are coming in Burzynski II, but when it comes to me no doubt Merola is referring to this bit of yellow journalism in 2010 from an antivaccine propagandist named Jake Crosby, entitled David Gorski’s Financial Pharma Ties: What He Didn’t Tell You” [5]
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GorskGeek then ad hocs ad nauseum about ad hominem fallacy

“In this fallacy, rather than addressing the actual evidence and science that demonstrate their favorite brand of woo to be nothing more than fairy dust, the idea is to preemptively attack and discredit the person“

“The ad hominem is not just insults or concluding that someone is ignorant because, well, they say ignorant things and make stupid arguments (in which case calling someone stupid or ignorant might just be drawing a valid, albeit impolitic, conclusion from observations of that person’s behavior), but rather arguing or insinuating that you shouldn’t accept someone’s arguments not because their arguments are weak but because they have this personal characteristic or that or belong to this group or that“ [6]
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GorskGeek, the huckster of hackery laments that “The Skeptics™” are subject to character assassination, NOT because of their “science-based medicine”, but, alas, for being biased, lying, cowards

So, he must justify that as to why he then ad hominems those who he harangues:
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“In Burzynski The Movie, Dr. Whitaker has his nose embedded so far up Dr. Burzynski’s rectum that Dr. Burzynski wouldn’t need a colonoscopy if Merola just strapped a light to Dr. Whitaker’s face“ [7]
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“In the meantime, I realized that seeing Josh Duhamel stick his proboscis firmly up Burzynski’s posterior was not enough to explain the disturbance that I was feeling“ [8]
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GorskiGeek seems to have an unhealthy infatuation with ASS

My suppositorsition is that GorskiGeek, the highfalutin’ He-Man of hypocrisy, does wax on, wax off, waxes phonetic about ASS, because he is the apex of ASSmuchness
——————————————————————
In essence, he denies the toxicity of water in terms I’ve never seen anyone try to downplay before:

Water… is toxic?

This was perhaps the most stunningly malicious use of emotion to manipulate the reader in any of the propaganda pieces against H2O in history
——————————————————————
GorskGeek claims:
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“Josia, as readers of Liz Szabo’s report will know, was the six year old boy with an inoperable brain tumor who died of hypernatremia (elevated sodium levels in the blood) as a result of Burzynski’s therapy“
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GorskGeek gassticulates:
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“As I pointed out last Friday and Szabo reported in her story, before his death Josia’s serum sodium was measured at 205 mEq/L, way above the normal range of 136-145 mEq/L and well into the lethal range”

“As I pointed out then, I’ve never seen a sodium level anywhere near that high“

“During my residency, the highest I recall ever seeing was maybe around 180 mEq/L”
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As I already pointed out previously in this article:

GorskGeek and USA TODAY both hashtag Failed to point out that a boy, the same age as Josia Cotto, survived a serum sodium (Na+) level of 234 mEq/L

GorskGeek claims that Josia died of hypernatremia (elevated sodium levels in the blood) as a result of Burzynski’s therapy

GorskGeek does NOT provide ANY citation(s), reference(s), and / or link(s) in support of his claim, and does NOT provide a copy of the autopsy

GorskGeek’s brain cells must be “sleeping in excess”, hence the symptoms of lethargy progressing ignorance of adverse events which approach critical black hole levels

Of course, none of this is new information
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GorskGeek hacks:
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“I also note that one of Burzynski’s most famous patients, Hannah Bradley, who with her partner Pete Cohen proclaims herself cured of her brain cancer, thanks to Burzynski, suffered some pretty serious toxicities from antineoplastons herself, including high fevers to 103.9° F, shaking chills, and severe rashes“

“Pete even documented how badly Hannah reacted to antineoplastons in his YouTube documentary Hannah’s Anecdote”
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GorskGeek flummoxes in that he erred to elucidate that the “rash” which Hannah
experienced, even entailed epilepsy anti-seizure medication [4]

GorskGeek gambols the gabroni gambit by giving nothing but glib reasons for his genetically challenged gestation of Hannah’s vlogs after gears up for Great Britain

Yes, GorskGeek is gabless about Hannah’s progress in the G.B. as a germinating gerbil, as far as flu or fever, perhaps fearing his failure to feature any fact-checking facilitation a fanboy of Fanectdotes should fittingly fictionalize
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The rest of GorskGeek’s rant reads like a greatest hits compilation from cancer hacks

You get the picture

That’s the whack-n-hack counterhackfensive trying to shore up Liz Szabo’s sorry article
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GorskGeek blowshard and long about the FDA Form 483′s findings, but does NOT heed his massive failure to be persuaded that:

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

“The FDA has not yet issued final conclusions”
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Who would doubt that if GorskGeek were to blog about Burzynski’s 1997 criminal trial, that he would NOT list each and every one of the 34 counts of mail fraud, 40 counts of violating Food and Drug Administration regulations, and the 1 contempt-of-court charge; all “allegations”, which netted the U.S. Gubment absolutely NOTHING ? [9]
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GorskGeek idolizes the Burzynski Research Institute (BRI) IRB, because of Burzynski’s scientific publications, which indicate:
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2003 – Membership of the Institutional Review Board (IRB) was in agreement with the Food and Drug Administration (FDA) [10]
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3/2004 – Membership of the Institutional Review Board (IRB) was in agreement with the Food and Drug Administration (FDA) [10]
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9/2004 – Membership of the Institutional Review Board (IRB) was in agreement with the Food and Drug Administration (FDA) [10]
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2004 – Membership of Institutional Review Board (IRB) was in compliance with FDA guidelines [10]
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6/2005 – Membership of the Institutional Review Board (IRB) was in agreement with the Food and Drug Administration (FDA) [10]
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GorskGeek then does a piss-poor “slight of hand job”, jerking the reader off about Pseudoprogression, pseudoresponse, so-called pseudoprogression, and “One phenomena, termed Pseudo-Progression (psPD)”

GorskGeek falls flat face first for failing to show this phenomenon has factually happened [11]

GorskiGeek, looks like back to the drawerin’ board for you !
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REFERENCES:
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[1] – 11/18/2013 – Eric Merola and Stanislaw Burzynski respond to the FDA findings and the USA TODAY story. Hilarity ensues:
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http://scienceblogs.com/insolence/2013/11/18/eric-merola-and-stanislaw-burzynski-respond-to-the-fda-findings-and-the-usa-today-story-hilarity-ensues/
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[2] – 11/18/2013 – The Burzynski Empire strikes
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http://www.sciencebasedmedicine.org/the-burzynski-empire-strikes-back/
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[3] – 11/11/2013 – “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:
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https://stanislawrajmundburzynski.wordpress.com/2013/11/11/www-amazingmeeting-com-www-randi-org-lanyrd-com2013tam-forums-randi-orgforumdisplay-php/
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[4] – 11/19/2013 – Critiquing: Stanislaw Burzynski in USA Today: Abuse of clinical trials and patients versus the ineffectiveness of the FDA and Texas Medical Board (Hyperactivity versus Hypernatremia, and Hannah Bradley):
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https://stanislawrajmundburzynski.wordpress.com/2013/11/19/httpscienceblogs-cominsolence20131115stanislaw-burzynski-in-usa-today-abuse-of-clinical-trials-and-patients-versus-the-ineffectiveness-of-the-fda-and-texas-medical-board-2/
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[5] – 2/18/2013 – Dr. Stanislaw Burzynski’s cancer “success” stories:
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http://www.sciencebasedmedicine.org/stanislaw-burzynskis-cancer-success-stories/
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[6] – 6/14/2010 – In which Dr. Gorski once again finds himself a target of the “pharma shill” gambit
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http://www.sciencebasedmedicine.org/in-which-i-am-once-again-in-the-crosshairs-of-age-of-autisms-pharma-shill-machine-gun/
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[7] – 11/29/2011 – Burzynski The Movie: Is Stanislaw Burzynski a pioneering cancer researcher or a quack?:
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http://scienceblogs.com/insolence/2011/11/29/burzynski-the-movie-subtle-its-not/
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[8] – 2/18/2013 – As Josh Duhamel shills for the Burzynski Clinic, Eric Merola prepares to carpet bomb the blogosphere with nonsense:
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http://scienceblogs.com/insolence/2013/02/18/as-josh-duhamel-shills-for-the-burzynski-clinic-eric-merola-prepares-to-carpet-bomb-the-blogosphere-with-nonsense/
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[9] – 9/25/2013 – Critiquing: National Council Against Health Fraud, Inc. – NCAHF News: JURY NULLIFICATION THWARTS BURZYNSKI CONVICTION:
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https://stanislawrajmundburzynski.wordpress.com/2013/09/25/critiquing-national-council-against-health-fraud-inc-ncahf-news-jury-nullification-thwarts-burzynski-conviction/
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[10] – 7/2/2013 – Burzynski: Institutional Review Board (IRB):
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https://stanislawrajmundburzynski.wordpress.com/2013/07/02/burzynski-institutional-review-board-irb/
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[11] – 11/20/2013 – Critiquing: Stanislaw Burzynski in USA Today: Abuse of clinical trials and patients versus the ineffectiveness of the FDA and Texas Medical Board (swell inflammation phenomenon):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/20/httpscienceblogs-cominsolence20131115stanislaw-burzynski-in-usa-today-abuse-of-clinical-trials-and-patients-versus-the-ineffectiveness-of-the-fda-and-texas-medical-board-3/
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Critiquing: Stanislaw Burzynski in USA Today: Abuse of clinical trials and patients versus the ineffectiveness of the FDA and Texas Medical Board (swell inflammation phenomenon)

Liz Szabo’s USA TODAY “killer cancer” article as interpreted by “Orac” made 3 claims [0]:
——————————————————————
“Conventional cancer treatment can also cause tumors to swell temporarily,” [1]

“due to”

“inflammation,” [2]

“A patient who isn’t familiar with this”

“phenomenon” [3]

“may assume her tumor is growing”
——————————————————————
The issue with citing these 3 studies is that each then needs to be reviewed to determine if they have any relevance to the patients Burzynski has treated in the phase II clinical trials:
——————————————————————
[1] – 12/2009 – Pseudoprogression and pseudoresponse in the treatment of gliomas
——————————————————————
1. Has Burzynski treated patients with gliomas, brain tumours, or recurrent glioblastoma ?
——————————————————————
2. Has Burzynski’s patients been treated with combined chemo-irradiation with temozolomide which may induce in 20-30% ?
——————————————————————
[2] – 5/2008 – Clinical features, mechanisms, and management of pseudoprogression in malignant gliomas
——————————————————————
1. Has Burzynski treated patients with glioblastoma ?
——————————————————————
2. Have any of Burzynski’s patients been treated with temozolomide chemoradiotherapy ?
——————————————————————
3. so-called pseudoprogression
can occur in up to 20% of patients
——————————————————————
4. can explain about 1/2 of 20%
——————————————————————
[3] – In support of this “phenomenon”, the article provides a link to a Canadian web-site which
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 [4]
——————————————————————
GorskGeek stupidly suppositories:
——————————————————————
“It’s very heartening to see a story like this in a major news outlet, and I must congratulate Ms. Szabo for her thorough deconstruction of the phenomenon that is Stanislaw Burzynski“
——————————————————————
GorskGeek, just because a great portion of Liz Szabo’s USA TODAY article quoted verbatim from The Skeptics™ play book, does
NOT mean she was anymore successful at “deconstructing” Burzynski [5], anymore than you have NOT
——————————————————————
GorskGeek then regurgitates:
——————————————————————
“Remember how I said that Bob Blaskiewicz will want your help?”

“Now’s the time to contact him, if you haven’t already”
——————————————————————
GorskGeek, Bob Blaskiewicz needs “HELP” in the same manner as you need “HELP”, because, as I have proved, you both act like compulsive liars
======================================
REFERENCES:
======================================
[0] – 11/15/2013 – Stanislaw Burzynski in USA Today: Abuse of clinical trials and patients versus the ineffectiveness of the FDA and Texas Medical Board
——————————————————————
http://scienceblogs.com/insolence/2013/11/15/stanislaw-burzynski-in-usa-today-abuse-of-clinical-trials-and-patients-versus-the-ineffectiveness-of-the-fda-and-texas-medical-board/
======================================
[1] – 12/2009 – Pseudoprogression and pseudoresponse in the treatment of gliomas
pseudo-phenomenona
——————————————————————
http://www.ncbi.nlm.nih.gov/pubmed/19770760/
——————————————————————
Curr Opin Neurol. 2009 Dec;22(6):633-8. doi: 10.1097/WCO.0b013e328332363e
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/19770760/
——————————————————————
Department of Neuro-Oncology, Antoni van Leeuwenhoek Hospital/Netherlands Cancer Institute, Amsterdam, The Netherlands
======================================
[2] – 5/2008 – Clinical features, mechanisms, and management of pseudoprogression in malignant gliomas
——————————————————————
http://www.ncbi.nlm.nih.gov/pubmed/18452856/
——————————————————————
Lancet Oncol. 2008 May;9(5):453-61. doi: 10.1016/S1470-2045(08)70125-6
——————————————————————
http://www.ncbi.nlm.nih.gov/m/pubmed/18452856/
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Department of Neuro-oncology, Daniel den Hoed Cancer Centre, Erasmus Medical Centre, Rotterdam, Netherlands
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http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(08)70125-6/fulltext
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occurs more frequently and earlier after temozolomide chemotherapy than after radiotherapy alone
chemoradiotherapy
recurrent malignant glioma progression within 1st 3 months
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[3] – What is Pseudo-Progression Following Treatment for Glioblastoma Multiforme?
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Phenomenon – Psuedo-progression (GBM), Brain Tumour Foundation of Canada
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http://www.braintumour.ca/1649/ask-the-expert-psuedo-progression-gbm
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[4] – 1/2010 – Pseudoprogression following chemoradiotherapy for glioblastoma multiforme
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http://www.ncbi.nlm.nih.gov/pubmed/20169771/
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Can J Neurol Sci. 2010 Jan;37(1):36-42
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http://www.ncbi.nlm.nih.gov/m/pubmed/20169771/
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[5] – 11/17/2013 – Critiquing: Stanislaw Burzynski in USA Today: Abuse of clinical trials and patients versus the ineffectiveness of the FDA and Texas Medical Board (Getting Worse is Getting Better):
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https://stanislawrajmundburzynski.wordpress.com/2013/11/17/httpscienceblogs-cominsolence20131115stanislaw-burzynski-in-usa-today-abuse-of-clinical-trials-and-patients-versus-the-ineffectiveness-of-the-fda-and-texas-medical-board/
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