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

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

“There is a long segment about “The Skeptics”

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

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

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

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

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

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

I thought it was: AS2 1 😊

They are “basically the same thing” ? 😳

What does Burzynski say ? [6]

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

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

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

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

That does NOT look like “basically the same thing” to me πŸ˜›

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(6:50)
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Gorski founders on:

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

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

At the time it was:

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

“Listen to Burzynski’s lawyer!”

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

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

“It was a joke”

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

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

He can say whatever he wants

GorskGeek is NOT a lawyer πŸ˜“

And there’s an excellent reason why

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

FACT:

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

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

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

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

PATIENTS WITH REFRACTORY MALIGNANCIES

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

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

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

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

Gorski suggests that 3 different opinions could have misdiagnosed Tori Moreno

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

The changing pattern of hypernatremia in hospitalized children

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

“No”

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

“Wahahaha” πŸ‘Ώ
——————————————————————
Dr. Stanislaw Burzynski on Wikipedia:

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

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

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

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

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

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

(laughing) [5]
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Enlightening ?

Inspiring ?

Amazing ?

Hypocrites

Apparatchiks [20]
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REFERENCES:
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[1]David Gorski – Why We Fight (Part I): Stanislaw Burzynski Versus Science-Based Medicine – TAM 2013 11/8/2013 (22:44)
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[2]Robert Blaskiewicz – Why We Fight (Part II): It’s All About The Patients – TAM 2013 11/8/2013 (22:36)
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[3] – Medical Cranks And Quacks
TAM 2013 JREF
11/8/2013 (42:42)
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[4]“Galileo’s Lawyer” Richard A. Jaffe, Esq.
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http://www.richardjaffe.com
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[5] – 11/9/2013 – 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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[6] – 6/2012 – Journal of Cancer Therapy, 2012, 3, 192-200 doi:10.4236/jct.2012.33028 Published Online June 2012, Pg. 192
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http://www.burzynskiclinic.com/images/stories/Publications/9219.pdf
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[7]Burzynski: Oh, RATS!!!:
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https://stanislawrajmundburzynski.wordpress.com/2013/07/26/the-lancet-oncology-peer-review-team-d-12-01519-fail-2/
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[8] – Critiquing: How Stanislaw Burzynski became Burzynski the Brave Maverick Doctor, part 1:
β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”
https://stanislawrajmundburzynski.wordpress.com/2013/07/22/critiquing-how-stanislaw-burzynski-became-burzynski-the-brave-maverick-doctor-part-1/
======================================
[9] – 9/19/2013 – Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet β€œfact sheet”:
β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”
https://stanislawrajmundburzynski.wordpress.com/2013/09/19/critiquing-national-cancer-institute-nci-at-the-national-institutes-of-health-nih-cancernet/
======================================
[10] – 9/25/2013 – Critiquing: National Council Against Health Fraud, Inc. – NCAHF News: JURY NULLIFICATION THWARTS BURZYNSKI CONVICTION:
β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”
https://stanislawrajmundburzynski.wordpress.com/2013/09/25/critiquing-national-council-against-health-fraud-inc-ncahf-news-jury-nullification-thwarts-burzynski-conviction/
======================================
[11] – 7/9/2013 – Burzynski: The Original 72 Phase II Clinical Trials:
β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”
https://stanislawrajmundburzynski.wordpress.com/2013/07/09/burzynski-the-original-72-phase-ii-clinical-trials/
======================================
[12] – 4/26/2013 – Burzynski: FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in the Company’s Antineoplaston CLINICAL TRIALS:
β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-fda-requirements-that-cancer-patients-utilize-more-traditional-cancer-treatment-options-in-order-to-be-eligible-to-participate-in-the-companys-antineoplaston-clinical-trials/
======================================
[13] – Tori Moreno
β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”
http://www.cancerinform.org/aburzinterview2.html
======================================
[14] – 9/1999 – Pediatrics. 1999 Sep;104(3 Pt 1):435-9
β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”
http://www.ncbi.nlm.nih.gov/m/pubmed/10469766/
======================================
[15] – 11/2/2013 – Critiquing: Dr. Stanislaw Burzynski’s cancer β€œsuccess” stories:
β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”
https://stanislawrajmundburzynski.wordpress.com/2013/11/02/critiquing-dr-stanislaw-burzynskis-cancer-success-stories/
——————————————————————
10/25/2013 – Hannah Bradley – I Feel Empowered, In Control Of My Body: Four Women On Fighting Cancer With Alternative Therapies http://www.telegraph.co.uk/health/10383724/I-feel-empowered-in-control-of-my-body-four-women-on-fighting-cancer-with-alternative-therapies.html
β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”
https://stanislawrajmundburzynski.wordpress.com/2013/10/25/hannah-bradley-i-feel-empowered-in-control-of-my-body-four-women-on-fighting-cancer-with-alternative-therapies-httpwww-telegraph-co-ukhealth10383724i-feel-empowered-in-control-of-my-body-fo/
======================================
[16] – NOT ORDINARY CHEMOTHERAPY
β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”
https://bulk.resource.org/courts.gov/c/F3/27/27.F3d.153.93-2071.html
======================================
[17] – 9/4/2013 – University of Michigan, where is alum Dr. David H. β€œOrac” Gorski’s Grapefruits ?:
β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”
https://stanislawrajmundburzynski.wordpress.com/2013/09/04/university-of-michigan-where-is-alum-dr-david-h-orac-gorskis-grapefruits/
======================================
[18] – 10/13/2013 – Why β€œThe Skepticsℒ” Perfessor Robert J. (don’t call me β€œBobby”) β€œBob” Blaskiewicz (@rjblaskiewicz) of University of Wisconsin, Eau Claire, β€œFame,” is a Coward and a Liar:
β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”
https://stanislawrajmundburzynski.wordpress.com/2013/10/13/why-the-skeptics-perfessor-robert-j-dont-call-me-bobby-bob-blaskiewicz-rjblaskiewicz-of-university-of-wisconsin-eau-claire-fame-is-a-coward-and-a-liar/
======================================
[19] – 10/27/2013 – β€œThe Skepticsℒ” Burzynski Bias, Censorship, Lies, and Alibi’s: September 28, 2013 β€œThe Skepticsℒ” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”
https://stanislawrajmundburzynski.wordpress.com/2013/10/27/the-skeptics-lie-lied-lies-liars-lying-burzynski-bias-censorship-lies-and-alibis-september-28-2013-the-skeptics-burzynski-discussion-by-bob-blaskiewic/
======================================
[20] – 11/9/2013 – Wikipedia Articles:
β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”β€”
https://stanislawrajmundburzynski.wordpress.com/2013/09/11/burzynski-timeline/
======================================

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My Critique of Bob Blaskiewicz (Colorado Public Television – PBS CPT12)

Skeptical Humanities
Learning is Cool

A Letter to the PBS Ombudsman about CPT12β€²s Airing of

β€œBurzynski”
http://t.co/RxDZHDN2RM

Posted by Bob

PBS Ombudsman Michael Getler

“To understand the complexities and history involved takes a lot of work, far more than we could possibly expect of Mr. Getler”

(or, as I have proven, of YOU)
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/critiquing-bob-blaskiewicz-burzynski-cancer-is-serious-business-part-ii

“That said, however, I do disagree with some of his conclusions”

(You could see that coming a mile away, couldn’t you?)

Getler starts off:

[ ” … It is about the decades-long struggle of a Polish-born physician and biochemist, Stanislaw Burzynski, who set up a clinic in Texas in 1976, to achieve acceptance for a cancer-cure therapy based on a treatment he developed based on what he calls β€œAntineoplastons.” [ANP]”

“I submit this is already wrong

There is little evidence that Burzynski is at all serious about developing antineoplastons for wider marketing”

THAT certainly explains the Phase III stuff

“If that were true, surely he would have managed to have completed and published a single advanced trial in 35 years

“If you look at the trials he’s been required to register at clinicaltrials.gov, you see over 60 trials, 1 completed, and none published

NONE”

Bobby, where is the

Citation(s),

Reference(s), and / or

Link(s)

that support your

“required to register”

statement ?

NONE ?

Are you a sociopath who thinks that people should believe you just because you blogged or twitted it ?

“This is important because he is restricted to giving his ANP in clinical trials

But he apparently abandons his trials, almost all of them

This is not normal”

Bobby, how many is

“almost all of them” ?

“He charges patients out the nose to participate in the clinical trials

This is not normal”

Does it cost as much as any of THESE ?

Cost cancer
http://articles.cnn.com/2009-06-16/politics/health.care.hearing_1_health-insurance-post-claims-underwriting-individual-health?_s=PM:POLITICS

2008 – Cost cancer insurance
http://www.nytimes.com/2008/07/06/health/06avastin.html?_r=0

Cost cancer chemo up-front
http://online.wsj.com/public/article/SB120934207044648511.html?mod=2_1566_topbox#articleTabs%3Darticle

3/2012
http://www.avalerehealth.net/news/2012-04-03_COA/Cost_of_Care.pdf

CHEMOTHERAPY:
9/24/2012

http://www.charlotteobserver.com/2012/09/24/3549634/prices-soar-as-hospitals-dominate.html

5/14/2012
http://articles.washingtonpost.com/2012-05-14/national/35457286_1_lung-cancer-drug-drugs-work-multiple-myeloma-patients

RADIATION:
1/4/2013

http://www.ucsf.edu/news/2013/01/13370/how-prostate-cancer-therapies-compare-cost-and-effectiveness

3/15/2012
http://www.ascopost.com/issues/march-15-2012/rising-costs-in-radiation-oncology-linked-to-medicare-coverage.aspx

http://cancer.disease.com/Treatment/Radiation-Therapy

“This is not the behavior of someone who intends to market the product widely later and expects a return on an investment

It sure looks like someone taking the money while he can”

THAT sure explains THIS 7/5/2012 Marketing and Consulting Agreement contract:
http://www.sec.gov/Archives/edgar/data/724445/000110465912047927/a12-16018_1ex10d10.htm

“I put the word β€œdocumentary” in quotes above because while the actual film does indeed document very well Burzynski’s seemingly endless battle to win acceptance and approval for his treatment against the FDA, National Cancer Institute, patent challenges and big pharmaceutical companies β€” and includes very powerful filmed interviews with cancer survivors who say his treatment (in Texas, where it was allowed) saved them β€” it doesn’t have the kind of critical other-side that one is used to in other documentaries

That last part is true

the movie is one-sided”

Bobby, you do know that Eric Merola offered oncologist and self-described researcher, David H. Gorski

(@gorskon @oracknows @ScienceBasedMed #sciencebasedmedicine http://www.scienceblogs.com/Insolence http://www.sciencebasedmedicine.org)

the opportunity to appear in

Burzynski: Cancer is Serious Business, Part II,

and he REFUSED, right ?

“Of course, why this is might be more apparent if Mr. Getler had realized that Merola’s cousin was a patient of Burzynski (she later died, of course) and that Merola raised funds for his cousin’s treatments on his website

Merola is not impartial

He has skin in the game

He has sunk an enormous amount into Burzynski”

Yeah, just like every other documentary film-maker or director of multiple movies re the same subject (Jaws, Terminator, Predator, Alien, etc.)

“Mr. Getler mentions that Shari Bernson, the person responsible for the programming and who appeared in fundraising spots, described the movie as β€œcontroversial.”

To someone on the outside, it may appear to be controversial

To someone who understands the science and process of publication and who has found endless descriptions of how patients end up making really, really bad choices out of desperation at that clinic, however, there is no controversy”

The “controversy” is “The Skeptics” who do NOT know how to “Fact-Check,” and instead “Insert Foot in Mouth”

“The fact remains that after 35+ years, the Clinic has never produced a single reproducible result that would constitute the barest minimum for serious consideration among experts

It just hasn’t”

That certainly explains the antineoplaston studies done in Poland, South Korea, Russia, Egypt, Japan, China, Taiwan (ROC), and the USA

That China published their most recent antineoplaston A10 study 10/1/2010

Journal of Radioanalytical and Nuclear Chemistry

October 2010, Volume 286, Issue 1, pp 135-140

#Burzynski References: 5. – 6.

The Randomized Japan study is scheduled for publication THIS year

“Should that ever happen (I’m not holding my breath), then, hell, yes, we’ll be on board cheering the advance of science”

“But he has to play by the rules

And this is important too, playing by the rules that all real researchers abide to

Part of the FDA’s job is to ensure that Burzynski’s people are doing this

And on February 7th, they were doing just that; they were in the facility inspecting to make sure that Burzynski’s team was playing by the rules

In a FOIA release this week, the FDA revealed a number of things that had been found out and reported to the clinic by the time the movie aired

By law, the Clinic had 15 days to respond, so if they responded, it was before CPT12β€²s love-in

(The observational notes can be found here:”
http://skepticalhumanities.files.wordpress.com/2013/03/burzynskiform483feb2013.pdf)

“Two investigators observed:”

β€œThe IRB [Institutional Review Board] used an expedited review procedure for research which did not appear in an FDA list of categories eligible for expedited review, and which had not previously been approved by the IRB”

“Specifically, your IRB routinely provided expedited approvals for new subjects to enroll under Single Patient Protocols.”

“[2 adults and 3 pediatric patients are mentioned]”

β€œThe IRB approved the conduct of research, but did not determine that the risks to subjects were reasonable in relation to the anticipated benefits (if any) to subjects, and to the importance of the knowledge that might be expected to result”

“Specifically, your IRB gave Expedited Approval for several Single Patient Protocols (SPP) without all the information necessary to determine that the risk to subjects are minimized.”

“[4 examples follow]”

β€œThe IRB did not determine at the time of initial review that a study was in compliance with 21 CFR Part 50 Subpart D, β€˜Additional Safeguards for Children in Clinical Investigations.’”

“Specifically, an IRB that reviews and approves research involving children is required to make a finding that the study is in compliance with 21 CFR Part 50 Subpart D, β€˜Additional Safeguards for Children in Clinical Investigations.’”

“Your IRB approved research involving children without documentation of the IRBs finding that the clinical investigation satisfied the criteria under Subpart D.””

“[3 examples follow and there is a note that this is a repeat observation that had been found in an Oct 2010 Inspection.]”

β€œThe IRB did not follow its written procedure for conducting its initial review of research”

“Specifically, the IRB is required to follow its written procedures for conducting initial and continuing review”

“Your IRB did not follow your written procedures for conducting initial and continuing review because these subjects received IRB approval via an expedited review procedure not described in your Standard Operating Procedures”

“If your IRB would have followed your own SOP for initial and continuing review, the following subjects would have received review and approval from the full board rather than an expedited review.””

“[2 adults and 3 pediatric patients are listed.]”

β€œThe IRB has no written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any unanticipated problems involving risks to human subjects or others”

“Specifically, your current SOP-2012 v2-draft doc does not describe the requirements on Investigators on how unanticipated problems are reported to the IRB, Institutional Official, and the FDA, such as time intervals and the mode of reporting, or otherwise address how the prompt reporting of such instances will be ensured.”

β€œThe IRB has no written procedures [in the SOP-2012 v2-draft doc] for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any instance of serious or continuing noncompliance with theses [sic] regulations or the requirements or determinations of the IRB.”

β€œA list of IRB members has not been prepared and maintained, identifying members by name, earned degrees, representative capacity, and any employment or other relationship between each member and the institution.”

“You have to play by the rules”

So, NOT as bad as THIS 9 pager ?
http://www.pharmalive.com/fda-warns-stem-cell-company-over-violations

“I’m not sure that this round of investigation is over yet, as the audience at the premier of the sequel was apparently told that the FDA was still on site”

“Researchers should not be playing fast and loose with the rules that protect children (a protected subject population, like prisoners and students–yeah, I’m IRB certified)”

“There should be procedures in place to see that proper oversight and reporting of unexpected events is ensured”

“Hell, there was apparently no document even saying WHO was on the IRB!”

“This is not a report on a serious research institution”

“It’s more like the observations of the IRB of a clown school”

How many more businesses with more IRB issues than Burzynski did you find during you intense “Fact-Finding” mission ?

“Back to Mr Getler’s letter:”

“On the other hand, Bernson’s sidekick on the in-studio, pledge-drive promotion who was interviewing the clinic spokesman, made me gag when she said,

β€œI’m Rebecca Stevens and I’m proud to be a journalist who asks the hard questions.”

There were no hard questions”

[I believe the question that followed up this statement was, “What is peer-review?”–RJB]

“And where Bernson may have gone too far, depending on who you believe, was in her statement that:

β€œAntineoplaston therapy has had significant success rates with terminal brain cancer patients and especially in children.”

No, she went too far no matter who you believe, and his next paragraph demonstrates this:”

“The National Cancer Institute, reporting last month on Antineoplastons, said, among other things:

β€œNo randomized, controlled trials showing the effectiveness of antineoplastons have been published in peer-reviewed scientific journals”

and that they are

β€œnot approved by the U.S. Food and Drug Administration for the prevention or treatment of any disease.”

Aaaand…how’s that controversial?

In light of this, how could Sherri possibly be right?

My bottom line is that CPT12 obviously has a right to show this film

Nobody questions that

“What we wanted, and what was offered to the station, was the opportunity to have an independent oncologist in the studio at the time of the broadcast, you know, to stir up the kind of informed discussion the station says they want to have instead of settling for two True Believers talking to two CPT12 pitch people”

“When the station had that opportunity, they walked away from it”

“That’s indefensible”

“Especially when you consider that the people we are worried about, patients and their families, may NOT be as discerning as your average viewer, as CPT President Willard Rowland suggests in his response to the ombudsman:

β€œThe program’s airing is grounded in the station’s mission, specifically those portions about respecting our viewers as inquisitive and discerning citizens, addressing social issues and public concerns not otherwise adequately covered in the community, and cultivating an environment of discovery and learning.”

Some of them haven’t had good news since their diagnosis”

“Then they hear that some lone genius with the cure for cancer is operating in Houston and they are on the next flight down”

“I’ve seen it dozens of times, and I have hundreds more patients on deck to write about”

“These are vulnerable, vulnerable people who deserve the best information from their public broadcasters”

“I’m fairly disappointed by the tepid response, honestly”

“I have a hard time imagining that Mr. Getler, or Mr Willard Rowland for that matter, could possibly think that this program was anything but misleading if they spent a half hour at The OTHER Burzynski Patient Group, which chronicles, in patients’ own words, what goes on in that Clinic”

“All of the people told that getting worse is getting better”

“(for decades being fed the same line!),

the children having strokes

(unrelated to their tumors)

while on the medicine, the β€œterrifying” amounts of sodium that go into patients”

“The quasi-legalistic threats and phone calls to dissatisfied cancer patients”

“The untested chemo cocktails given to most of his patients”

“None of that was mentioned in the CPT12 fundraiser”

“Of course, that’s not Mr. Getler’s fight”

RJB
http://skepticalhumanities.com/2013/03/26/a-letter-to-the-pbs-ombudsman-about-cpt12s-airing-burzynski

Maybe you should go here and explain the critics actions:
https://www.facebook.com/questions/488444654552853