“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/
======================================
[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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Critiquing David H. Gorski – Quackademic Medicine

Twenty-one (21) things I learned (first hand) from the recent screening of David H. Gorski – Quackademic Medicine
(Or, in layman’s terms: 21 pick-up)

David Gorski (@gorskon) tweeted at 8:12am – 30 Mar 13:
http://t.co/Pctpb3RFHs

“Funny how you never see Orac and this person in the same place at the same time”

Orac (@oracknows) tweeted at 9:16am – 30 Mar 13:
http://t.co/uVDgYnrkOn

Posted by Orac on March 30, 2013

“Three weeks ago, a certain

β€œfriend”

(one David H. Gorski, MD, PhD, FACS, managing editor of
http://www.sciencebasedmedicine.org
#sciencebasedmedicine
http://www.scienceblogs.com/Insolence
@ScienceBasedMed @gorskon @oracknows)

of mine gave a talk to the National Capital Area Skeptics at the National Science Foundation in Arlington, VA”

(3/9/2013)
http://www.ncas.org/2013/02/mar-9-david-h-gorski-quackademic.html?m=1
The topic was one near and dear to my heart, namely quackademic medicine; so I couldn’t resist posting a link to the video”

(4/1/2013 – Amazingly the YouTube video displays “no stream” Quackademic Medicine – David H. Gorski, MD, NCASVideo: 1:19:14)

So in order to have a good laugh one must access:
http://scienceblogs.com/insolence/2013/03/30/funny-how-you-never-see-orac-and-this-person-in-the-same-place-at-the-same-time

1. Appropriately enough, GorskOrac starts with:

“What am I talking about here?”

Indeed !

2. It appeared that GorskOrac was not well prepared as he then refers to:

“a few months ago”

then:

“last fall”

and finally settles on:

“October”

3. He stumbles over words repeatedly

4. He seemed unaware that the position of the microphone matters
(It was to the Right; from the view of the audience, his Left)

5. One wonders where the funding for this fiasco came from

6. The presentation wasn’t exactly “pabulum for the soul”

7. Attempts at trying to be witty were painful to hear

Luckily he had a golden parachute;
his audience, who sometimes failed to prevent the crash landing of a number of his “skepticisms”

8. He mentioned:

“I really wish I thought up

“Quackademic” Medicine”

But then again, this is the individual who couldn’t even think up

“ORAC”
(Oxygen Radical Absorbance Capacity)

9. While describing an individual, he utters:

“He was a Quackademic before he turned to TV”

Leaving the listener to wonder if one is no longer a

“Quackademic”

once they have

“turned to TV”

10. GorskOrac eventually gets to

EBM = Evidence-based medicine

whereupon he ejaculates:

“But what does that really mean?”

I ask myself that quite a few times whenever I read Orac’s and his “Oracolytes'” blather on his blog, considering that a lot of it definitely does NOT contain much in the way of:

Evidence-based “facts”

11. He continues with:

“I like to point out there were other “BMs” before EBM”

To me, the video certainly brought to mind one of the biggest “BMs” known to Medicine:

“Bowel Movements”

12. He then goes on to mention

“3 of the most dangerous words in medicine”
(Experience-based medicine)

which is fitting, since Orac shows his “lack” of experience by stating, in relation to a person he was attempting to describe:

“It took her a few years but she died”

as if this particular “she” had been attempting to die for

“a few years”

13. Gorski refers to his Apple computer PowerPoint presentation display:

CAM according to NIH
(Complementary and Alternative Medicine according to the National Institutes of Health)

“Mind-body medicine”

and states:

“whatever that means”

It’s good to find out that just as with his blog, Davy knows his subject-matter in exquisite detail !

14. He refers to

“Manipulative … “

on the screen, and; not on list but he mentions

“Chiropractic”

as if this; along with all the other “alternative” therapies he ridicules, is NOT an effective therapy; which sure explains how when I was doing “dipping” exercises and had something in my upper body get out of position so that when I breathed deeply it felt like a bone was poking one of my lungs, that I should have eschewed chiropractic therapy for drugs, in an attempt to mask the pain instead of dealing with the muscular-skeletal issue

15. Maybe this should be why David should stick to lecturing about

“Butt Hoaxes”

and the like

16. However, I do have to give him credit for making at least 2 “factual” statements:

“I’m not an expert at this”

and

“It’s not my area of expertise”

17. Gorskon then presents:

“When the pluralism of free speech is extinguished, speech as such is no longer meaningful”

This is obviously a concept that OracKnows does NOT seem to “know” all that well, considering he blocked my comments from being posted on his blog, where I was continually pointing out the

misinformation,

disinformation,

and / or

misdirection

being posted on his blog and comments section

18. Dr. “Free Speech” then goes on to mention the “ubiquitous”

“Shruggie”

which aptly sums up his position on

“Free Speech”

19. Amusingly, a woman makes an appearance in the Q and A, positing; as opposed to “depositing BM”

(1:01:17)
“The only place … the best place to read … is the blog science based medicine . org

Gorski, I hope she was paid handsomely for her “ringing” endorsement

20. A man having experienced his “great” Memorial Sloan Kettering cancer experience:

(1:11:55)
“You’ve got Dr. Robert Lustig talking about sugar”

(which is timely, considering that on 3/28/2013, Dr. Lustig was on “The Colbert Report” talking to Stephen about sugar, and he has been an author on at least 24 cancer studies, including Phase I – III, and Randomized Clinical Trials)

21. David responds:

“Weeeell … ya know … the whole sugar feeds cancer thing”

Gorski, do you mean THIS:

“SUGAR FEEDS CANCER”

thing???

“In cancer, for example, cells multiply at a much faster rate than normal cells, FEEDING ON SUGARS like glucose”

Society of Nuclear Medicine and Molecular Imaging
http://www.snm.org/index.cfm?PageID=7988

“In many types of cancer, diseased cells metabolize the sugar in FDG more avidly than normal cells, and so stand out clearly on a PET/CT scan

This is because cancerous cells grow at a faster rate than surrounding tissue, FEEDING ON SUGARS like glucose”

New England PET Imaging System
http://www.nepetimaging.com/why.html

“All cells use glucose as an energy source

However, cancer cells grow faster than normal healthy cells and THEY USE GLUCOSE AT MUCH HIGHER RATE than normal cells”

Diagnostic Imaging Center at the NYU Clinical Cancer Center
http://www.med.nyu.edu/di/petCt/faqs.html

“When disease strikes, the biochemistry of your tissues and cells changes

In cancer, for example, cells begin to grow at a much faster rate, FEEDING ON SUGARS like glucose”

University of Maryland Medical Center
University of Maryland Medical System in Partnership with the University of Maryland School of Medicine
http://www.umm.edu/petct/pet_faq.htm

“A PET/CT scanner is used to detect cancer

… a sugar solution, is given because

cancer cells FEED OFF OF THE SUGAR and create β€œhot spots” that the scan will pick up on”

University of Tennessee Medical Center
http://www.utmedicalcenter.org/departments/radiology/radiology-patient-services/pet-ct-scan/

“cancer, for example, cells begin to grow at a much faster rate, FEEDING ON SUGARS like glucose”

North Mississippi Medical Center
http://www.nmhs.net/pet-ct_imaging.php

“Use of PET/CT scanning in cancer patients:

technical and practical considerations”

“malignant cell UTILIZES MORE GLUCOSE to meet its energy needs”
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1255942
Proc (Bayl Univ Med Cent). 2005 October; 18(4): 321–330
PMCID: PMC1255942
Baylor University Medical Center Proceedings

How many more would you like, Gorski???

(For some unknown reason, Orac could NOT handle a full hour of Q and A)

NO, this is NOT an “April Fools'” joke

Now, who has been “pwned”?

David Gorski (@gorskon) tweeted at 7:26am – 30 Mar 13:

My Critique of Orac’s: Stanislaw Burzynski versus regulations protecting human research subjects, revisited

Insolent Insolence

Here we go again

Unlike Orac

(David H. Gorski, @gorskon, @oracknows, @ScienceBasedMed, http://www.scienceblogs.com/Insolence, http://www.sciencebasedmedicine.org, #sciencebasedmedicine)
http://scienceblogs.com/insolence/2013/03/26/stanislaw-burzynski-versus-regulations-protecting-human-research-subjects-revisited

let’s compare Burzynski’s IRB to OTHER IRB’s

2/28/2013 – CoreValve

several cases in which site failed to obtain informed consent document (ICD)

2 cases – patients underwent CT angiography as screening procedure for trial without having signed screening ICD

3 cases – patients randomized into trial without having signed procedure ICD

investigator’s failure to notify within 5 days the sponsor or reviewing IRB of significant events

2 deaths
4/28/2011 – 1
5/11/2011 – 1
not reported to IRB until 10/21

2 cases – patients in trial underwent emergency procedures that deviated from trial protocol

1 case – no notification reported
1 case – deviation not reported for 5 weeks

“failure to maintain accurate, complete, and current records relating” to trial
http://www.forbes.com/sites/larryhusten/2013/02/28/fda-issues-warning-letter-to-corevalve-investigator

2/12/2013 – FDA Warning Letters to Institutional Review Boards
http://www.circare.org/FOIA/irblast.htm

11/29/2012 – Salem Hospital IRB

1. IRB failed to prepare and maintain adequate documentation of IRB activities

IRB is required to prepare and maintain adequate documentation of IRB activities including, but not limited to, copies of all research proposals, progress reports submitted by investigators, and all correspondence between IRB and investigators

IRB failed to adhere to requirement

Specifically, the IRB does not retain copies of the following:
a. Original protocols
b. Revised protocols
c. Informed consent documents
d. Protocol amendments
e. Progress report submissions, including all attachments
f. Correspondence between investigators and IRB

2. IRB failed to prepare and maintain adequate documentation of written procedures for IRB

IRB is required to prepare and maintain adequate documentation of written procedures for variety of IRB functions and operations

IRB failed to adhere to requirements

Specifically, IRB policies and procedures do not include written procedures to adequately address following functions and operations:

Conducting initial and continuing review or research;

Ensuring changes in approved research, during period for which IRB approval already given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to human subjects; and

Ensuring prompt reporting to IRB, appropriate institutional officials, and FDA of any serious or continuing noncompliance with regulations or requirements or determinations of IRB, or any suspension or termination of IRB approval

3. IRB failed to prepare and maintain list of IRB members identified by name; earned degrees; representative capacity; indications of experience sufficient to describe each member’s chief anticipated contributions to IRB deliberations; any employment or other relationship between each member and institution

IRB is required to maintain list of IRB members

IRB failed to adhere to requirement

IRB didn’t update roster when membership changed between 12/3/2008 and 3/21/2011
Specifically:

a. IRB meeting minutes 1/21/2009, indicate (b)(6) is present as IRB member

IRB meeting minutes 7/22/2009 announce (b)(6)’s resignation from IRB

IRB roster 12/3/2008 – 3/21/2011 doesn’t list (b)(6) as member of IRB

b. IRB meeting minutes 10/21/2009 indicate (b)(6) approved to become IRB member

IRB meeting minutes 1/20/2010 list (b)(6) as IRB member and show her voting on IRB activities

IRB roster 12/3/2008 – 3/21/2011, doesn’t list (b)(6) as member of IRB

IRB membership rosters aren’t updated as changes in membership occur

Therefore, FDA may not be able to determine that IRB is duly constituted as required

4. IRB failed to review proposed research at convened meetings at which majority of members of IRB are present, including at least one member whose primary concerns are nonscientific areas

Except when expedited review procedure used, IRB may only review proposed research at convened meetings at which majority of IRB members present, including at least one member whose primary concerns are nonscientific areas

IRB failed to adhere to requirements
Specifically:

a. IRB minutes 3/18/2009 indicate 6 of 8 IRB members present

2 IRB members recused themselves during initial review and vote for Study

study approved with less than majority of members present

b. IRB minutes 4/21/2010 indicate 5 of 8 IRB members present

One IRB member recused himself during initial review and vote for Study

study approved with less than majority of members present

c. IRB minutes 10/20/2010 indicate 5 of 8 IRB members present

One IRB member recused himself during review and vote for protocol and informed consent document changes for Study

changes approved with less than majority of members present

maintenance of IRB rosters is important part of IRB activities in that it provides documentation of current membership

appropriate roster maintenance helps ensure proper # of members present at IRB meetings when approving research activities

5. IRB failed to follow FDA regulations regarding expedited review procedures

FDA regulations require under expedited review procedure, review may be carried out by IRB chairperson or one or more experienced reviewers designated by IRB chairperson from among members of IRB; and IRB may use expedited review procedure to review either or both of the following:

(1) Some or all of research appearing on Federal Register list of categories of research eligible for expedited review and found by reviewer(s) to involve no more than minimal risk; or

(2) minor changes in previously approved research during period for which approval authorized.

as stated in Federal Register notice, expedited review procedure may be used for continuing review as follows:

a. Where

(i) research is permanently closed to enrollment of new subjects;

(ii) all subjects have completed all research-related interventions; and

(iii) c research remains active only for long-term follow-up of subjects; or

b. Where no subjects enrolled and no additional risks identified; or

c. Where remaining research activities are limited to data analysis

IRB failed to comply when used expedited continuing review for research not eligible for approval through expedited review procedure

IRB meeting minutes 1/21/2009 indicate continuing review for Study was conducted by expedited review

memorandum from Clinical Investigator, 12/23/2008, requesting annual review for study indicates study was open to enrollment and 4 subjects were currently enrolled

continuing review of Study wasn’t eligible for expedited review

IRB’s written response 7/11/2012 acknowledges validity of each of the violations listed

response states that IRB will develop new written procedures to address each violation

However, draft procedures weren’t submitted with response and will not be available until 2/28/2013

IRB’s response inadequate because it doesn’t describe process that IRB will use to train and educate IRB members, staff, and clinical investigators with respect to new written procedures

Without information, FDA cannot conduct informed evaluation of proposed corrective and preventive action’s potential ability to prevent recurrence of these or similar violations in future
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm330799.htm

9/24/2012 – Texas Applied Biomedical Services IRB

determined that IRB significantly violated applicable federal regulations governing operation and responsibilities of IRBs (available at
http://www.gpoaccess.gov/cfr/index.html)

This letter requests prompt corrective action to address the violations cited and discusses your IRB’s written response to noted violations

applicable provisions are cited for each violation

1. IRB failed to ensure no member participated in initial or continuing review of project in which member had conflicting interest

TABS RRC procedures manual, RRC Membership, states no member of Committee shall be involved in either initial or continuing review of activity in which he or she has conflicting interest, except to provide information requested by reviewing body

meeting minutes 1/26/2012 show 2 committee members, including you as Chairperson, participated in initial review and approval of clinical studies sponsored by (b)(4) (hereafter, (b)(4)) in which members had conflict of interest

Both you and (b)(6) voted to approve protocols sponsored by (b)(4) even though you both provided consulting services to (b)(4), assisting with writing protocols and informed consent documents, for which payment was requested

In your letter, you disagree with observation that TABS IRB members had conflict of interest with review of clinical studies

You explain that one of IRB committee members assisted in initial drafting of clinical study protocols and consulting services provided to (b)(4) by Texas Applied Biomedical Services and/or J Heinrich Consulting are not conflicts of interest

You further explain that consulting services provided β€œwere maintained separate and apart from any TABS Research Review Committee functions and actions.”

We disagree with explanations

2 members in question had conflicting interest when they participated in initial review and approval of protocols and informed consent documents, which they assisted in drafting

Conflicting loyalties, whether conscious or not, may influence IRB’s deliberations

2. IRB failed to prepare, maintain and follow written procedures for conducting initial and continuing review of research

IRB doesn’t have written procedure regarding IRB’s method of reviewing protocols and consent forms to ensure safeguards in place for children who participate in clinical study

meeting minutes 1/8/2012 show IRB approved investigational (b)(4) study involving children (b)(4) years old

In your letter, you acknowledge that TABS RRC hadn’t previously reviewed clinical investigational research studies involving pediatric subjects

You also state that SOP (standard operating procedure) will be written addressing pediatric clinical studies

3. IRB failed to fulfill membership requirements

IRB didn’t possess professional competence necessary to provide complete and adequate review of specific research activities
For example:

A. 1/8/2012 IRB reviewed and approved investigational (b)(4) study involving pediatric and adult subjects with disorders of (b)(4)

Review of IRB’s records indicates IRB lacked professional competence necessary to review study and determine whether it met criteria for approval, including whether risks to subjects were β€œreasonable in relation to anticipated benefits, if any, to subjects, and importance of knowledge that may be expected to result.”

IRB didn’t include individual with professional competence in treatment of (b)(4) disorders (e.g., a physician), nor is there any documentation to show that IRB invited individuals with competence in this area to assist in review of this study

B. 1/26/2012 IRB reviewed and approved 2 studies involving subjects

IRB did not include individual with professional competence (e.g. a physician) in treatment of (b)(4), nor is there documentation to indicate IRB invited individuals with competence in this area to assist in review of study

In your letter, you disagree with this observation

You explain that TABS IRB doesn’t have medical doctor as active, regular voting member of committee, but committee has access to core group of medical advisors that provide expertise and input for any and all clinical research studies committee encounters

Your letter states independent consultant with extensive experience in (b)(4) research was consulted when IRB reviewed and approved 2 studies involving subjects

meeting minutes 1/26/2012 failed to include documentation of any consult with specialist that was taken into account by IRB committee in decision to approve studies

4. IRB failed to determine that pediatric study is in compliance

Under Additional Safeguards for Children in Clinical Investigations, IRBs are required to review clinical investigations involving children as subjects and approve only those clinical investigations that satisfy criteria within certain risk categories

A. meeting minutes 1/8/2012 show IRB reviewed and approved investigational study involving children

meeting minutes don’t document IRB’s determination of level of risk involved, potential for direct benefit, likelihood of yielding generalizable knowledge about subjects’ disorder or condition, and opportunity to understand, prevent, or alleviate serious problem affecting health or welfare of children

B. meeting minutes 1/8/2012 don’t document IRB discussed and/or determined adequate provisions made for soliciting assent of children involved in investigational study

In your letter you state that all future studies involving pediatric subjects will be more closely scrutinized

Also in your letter you reference FDA Guidance for IRBs and Clinical Investigators – Informed Consent Document Content which provides FDA doesn’t require informed consent document to contain space for assent by children

We don’t accept your explanation

observation on Form FDA 483 doesn’t speak to whether FDA requires Informed Consent document to contain space for assent by children

Instead, FDA investigator observed IRB failed to determine at time of initial review that research study was in compliance

requires IRBs to find and document clinical investigations involving children as subjects meets requirements

meeting minutes 1/8/2012 fail to document additional requirements for review of study involving pediatric subjects

5. IRB failed to prepare and maintain adequate documentation of IRB activities

A. IRB didn’t maintain meeting minutes for 2011

During inspection you told FDA investigator IRB met twice in 2011

According to study list, protocol was modified and approved 8/24/2011 but no meeting minutes were available for review documenting IRB’s activities

In your letter, you confirm there are no meeting minutes for 2011 during which 2 meetings were held

You explain that due to computer crash all minutes and data for time frame were lost

You stated you would β€œre-create” meeting minutes and provide at later date

It is inappropriate and unacceptable record keeping practice for IRB to re-create minutes for 2011

B. IRB failed to maintain meeting minutes with sufficient detail to show actions taken by IRB and vote on actions

meeting minutes 1/8/2012 fail to show which IRB members present at meeting voted for, against or abstained

IRB reviewed and approved investigational study during 1/8/2012 meeting however meeting minutes don’t document that IRB reviewed and agreed with sponsor’s determination of risk status of investigational to be used in study

In your letter, you stated there was oversight in transcription for 1/8/2012 meeting minutes in recording each member’s vote

Your letter also states you will ensure more complete minutes in future meetings by assigning clerical person to act as recording secretary for IRB meeting

IRB’s failure to maintain meeting minutes is repeat violation identified in last 2 FDA inspections conducted 2007 and 2000

C. IRB failed to maintain IRB membership rosters for 2008 – 2012

IRB membership rosters don’t identify members by representative capacity and employment or other relationship between each member and institution

This is repeat violation identified during FDA inspection in 2000

In your letter, you submitted a revised membership roster 5/11/2012

revised roster fails to comply with regulations because it doesn’t indicate you are affiliated member though you are president of TABS, Inc. and Chairperson of TABS RRC

In addition, (b)(6) is listed as non affiliated member, but immediate family members of employee of institution can’t be deemed nonaffiliated

Based on repeated deficiencies found during last 3 inspections, we have no assurance IRB procedures are adequately protecting rights and welfare of human subjects of research

For this reason, and effective immediately,

Β· FDA will withhold approval of all new studies and reviewed by IRB; and

Β· No new subjects are to be enrolled in any ongoing studies and approved by IRB

restrictions will remain in effect until such time as FDA has evidence of adequate corrective actions and notifies you in writing that IRB’s corrective actions are satisfactory.

restrictions don’t relieve IRB of responsibility for receiving and reacting to reports of unexpected and serious reactions and routine progress reports from ongoing studies
http://www.fda.gov/iceci/enforcementactions/warningletters/UCM323868

FDA Warns Stem Cell Company Over Violations

Last April, the FDA inspected

Celltex Therapeutics

9 pages:
http://www.pharmalive.com/fda-warns-stem-cell-company-over-violations

Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product
Specifically,

You’ve manufactured (mesenchymal stem cells) MSC’s which you’ve released for distribution at least X times between 7/1/11 – present, however:

A. You haven’t performed a process validation for manufacturing MSC’s to assure batch uniformity and integrity as related to each of the following finished product characteristics: viability of cells, the specified cell count, cell type, and appearance of cells
B. You haven’t performed analyses on the final product to assure (b)(4) of the (b)(4) (b)(4) the final MSC’s
C. You haven’t verified the final product to assure the identity of the cell type in the final MSC’s
D. You haven’t performed assay to verify the MSC’s
E. you haven’t performed installation qualification, operational qualification, and performance qualification on the biological safety cabinets, the incubators, and the centrifuges
F. You haven’t performed a validation of your banking and thawing process to assure viability of MSC’s
G. You have no requirement for pressure differential between the clean rooms and the exterior rooms to assure that non-controlled air dose does not flow in the cleanrooms
H. You haven’t monitored the temperature or humidity of the processing rooms where you manufactured MSC’s

manufacturer’s manual for biological safety cabinets states they should be operated in environmental conditions of a (b)(4)

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile aren’t established, written, and followed
Specifically,

You’ve manufactured MSC’s which you released for distribution at least X times between 7/1/11 – present

MSC’s are intended to be administered to patients either intravenously or injected intra-articularly and must be sterile

The inspection revealed:

A. You’ve failed to validate aseptic MSC’s manufacturing process in order to prevent microbiological contamination

Sterility test failures have occurred of the following MSC’s: (b)(4), (b)(4), and (b)(4)
B. You’ve not validated your aseptic gowning process in order to prevent microbiological contamination

there’s no data to support validation/qualification of autoclave cycle

autoclave is used to sterilize gowning wardrobe (lab coat) and parts of incubators

C. You’ve not performed environmental swabbing of biological safety cabinets as part of environmental monitoring program

study hasn’t been performed to assure adequate air flow pattern underneath biological safety cabinet

biological safety cabinets used to aseptically manufacture MSC’s

D. Environmental test results of clean room, biosafety cabinets, and gowning area show isolation of microorganisms as result of use of settling plates

Some microbiological counts documented are beyond established specifications

There’s no data to show microorganism isolated have been identified or investigated

Written records are not made of investigations into the failure of a batch or any of its components to meet specifications

Specifically,

A failure investigation wasn’t performed for the following out of specification results and/or failures to determine the underlying reason or source of the failure

A. Sterility Testing: Sterility test results show the following MSC’s failed initial and repeat testing for sterility: (b)(4) and (b)(4)

The following MSC’s failed initial sterility before testing: (b)(4) and (b)(4)

B. Endotoxin Testing: Endotoxin test results show the following MSC’s units failed initial endotoxin testing on 12-20-11, on 12/7/11, and on 11-10-11

C. Environmental Testing: Bacteria and Fungi tests have been exceeded for the BSC-(Biosafety Cabinet-CleanRoom Gowning Area, (CleanRoom) (CleanRoom and BSC) (Biosafety Cabinet-Clean Room) BSC-M (Biosafety Cabinet-Manufacturing), BSC-Q (Biosafety Cabinet-Quality Control), CleanRoom

In addition there is no written procedure for conducting failure investigations

Drug product production and control records, are not reviewed by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed

Specifically,

You manufactured MSC’s you released for distribution at least X times between 7/1/11- present

you haven’t reviewed all manufacturing records, test records, endotoxin test records, or sterility test records prior to the release for distribution of the MSC’s that you manufactured as evidenced by the following:

A. inspector signature line on manufacturing record 10-20-11 blank

According to outgoing log MSC’s released for intravenous infusion 10-21-11

B. inspector signature line on manufacturing record 7-26-11 blank

According to outgoing log MSC’s released for intravenous (IV) infusion 10-11-11

C. inspector signature line on manufacturing record 10-6-11 blank

According to outgoing log MSC’s released for intravenous (IV) infusion 10-7-11

Batch production and control records don’t include complete information relating to production and control of each batch

Specifically:

A. You don’t document the addition of (b)(4) to your (b)(4) and (b)(4) media used in the manufacture of MSC’s

B. You don’t document the addition of (b)(4) to the (b)(4) media used for banking of MSC’s

C. You don’t document the checks of culture-expansion flasks of MSC’s for evidence of contamination

D. Manufacturing records lack required signatures

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm323853.htm

Critiquing Bob Blaskiewicz ( #Burzynski Cancer is Serious Business, Part II)

Critiquing Bob Blaskiewicz (#Burzynski Cancer is Serious Business, Part II) @rjblaskiewicz

rjblaskiewicz:

Except YOU do NOT actually believe in

“interesting and civil discussions,”

do you, Bobby ?

rjblaskiewicz:

Bobby, please point out where the Declaration of Helsinki supports your tweet
http://www.wma.net/en/30publications/10policies/b3

Please point out where the National Cancer Institute (NCI) at the National Institutes of Health (NIH) supports your tweet
http://m.cancer.gov/topics/factsheets/clinical-trials

rjblaskiewicz

rjblaskiewicz:

Do you mean THIS present ?

“Let’s make Houston cancer quack Burzynski pay!”

PZ Myers

“there is a plan to remind him of the grief he has caused”

“his snake oil”

“bilk people out of buckets of money”

“Crime does pay”

“This fraud”

“The Burzynski clinic is a place you go to die”

“The lies”

“his quackery”

Do you mean THIS St. Jude ?
St. Jude:

http://www.stjude.org/stjude/v/index.jsp?vgnextoid=403c6f9523e70110VgnVCM1000001e0215acRCRD

2/15/2012 – the U.S. Department of Health and Human Services has awarded St. Jude Children’s Research Hospital $4,314,800 for a childhood cancer survivor study

The new federal funds will be distributed by the National Cancer Institute (NCI)
http://cohen.house.gov/press-release/cohen-st-jude-receive-43-million-childhood-cancer-survivor-study

Tax-Exempt
Receives Federal Grants / Funds

http://www.stjude.org/stjude/v/index.jsp?vgnextoid=b7e79bb8a0cf5110VgnVCM1000001e0215acRCRD&cpsextcurrchannel=1

Donations to St. Jude are tax deductible as allowed by law
http://www.stjude.org/stjude/v/index.jsp?vgnextoid=6f8afa3186e70110VgnVCM1000001e0215acRCRD&vgnextchannel=2f62940504f9a210VgnVCM1000001e0215acRCRD

FORBES: St. Jude CEO – $742,718
http://www.forbes.com/fdc/welcome_mjx.shtml

Burzynski does NOT receive Federal Funds

Burzynski does NOT receive Federal Grants

Burzynski is NOT Tax-Exempt

Burzynski donations can NOT be deducted from a U.S. Tax Return

rjblaskiewicz:

THIS Phenylbutyrate (PB) ?

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

SODIUM PHENYLBUTYRATE was given an orphan drug designation by the FDA for use as an adjunct to

surgery,

radiation therapy, and

chemotherapy

for treatment of individuals with

primary or recurrent malignant glioma

Cumulative List of all Products that have received Orphan Designation: Total active designations: 2002 Effective: 5/5/2009
http://www.fda.gov/downloads/forindustry/developingproductsforrarediseasesconditions/howtoapplyfororphanproductdesignation/ucm162066.xls
PHENYLBUTYRATE and SODIUM PHENYLBUTYRATE are listed alphabetically in the lower 1/4th of this document

Pubmed 110 entries
Sodium Phenylbutyrate
β€œSodium Phenylbutrate (aka PB) …”

Sodium Phenylbutyrate (PB)
Year – Pubmed (110 entries)
1958 1st entry
1995 1st clinical trial
2001 Phase 1
2009 Phase 2
2012 Phase 3

rjblaskiewicz:

THESE trials ?

2003 – 2006 Phase II preliminary reports

2003 – Phase II

Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma:

a preliminary report
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs R D. 2003;4(2):91-101

recurrent diffuse intrinsic brain stem glioma

antineoplaston A10 and AS2-1

6 months median duration of treatment

of all 12 patients

2 years / 33.3% – Survival

2 / 17% – alive and tumour free for over 5 years since initial diagnosis

from the start of treatment

5 years – 1 alive for more than
4 years – 1 alive for more than

Only mild and moderate toxicities were observed, which included

3 cases of skin allergy

2 cases of:
anaemia
fever
hypernatraemuia

single cases of:
agranulocytosis
hypoglycaemia
numbness
tiredness
myalgia
vomiting

2003 – Protocol – recurrent diffuse intrinsic brain stem glioma
12 – Patients Accrued
10 – Evaluable Patients
2 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
3 / 30% – # and % of Patients Showing Stable Disease
2 / 20% – # and % of Patients Showing Progressive Disease

2004 – Phase II

Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma :

a preliminary report
http://www.ncbi.nlm.nih.gov/m/pubmed/15563234
Drugs R D. 2004;5(6):315-26

incurable recurrent and progressive multicentric glioma

antineoplaston A10 and AS2-1 (ANP)

9 – patients’ median age

6 patients were diagnosed with pilocytic astrocytoma

4 with low-grade astrocytoma
1 with astrocytoma grade 2

1 case of visual pathway glioma, a biopsy was not performed due to a dangerous location

16 months – The average duration of intravenous ANP therapy

19 months – The average duration of oral ANP

1 patient was non-evaluable due to only 4 weeks of ANP and lack of follow-up scans

1 patient who had stable disease discontinued ANP against medical advice and died 4.5 years later

10 patients are alive and well from 2 to >14 years post-diagnosis

Only 1 case of serious toxicity of reversible tinnitus, of 1 day’s duration, was described

2004 – Protocol – incurable recurrent and progressive multicentric glioma
12 – Patients Accrued
33% – % of Patients Showing Complete Response
25% – % of Patients Showing Partial Response
33% – % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease

2005 – Phase II

Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with antineoplastons A10 and AS2-1
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
Integr Cancer Ther. 2005 Jun;4(2):168-77

13 children with recurrent disease or high risk

6 (46%) survived more than 5 years

2005 – Protocol – recurrent disease or high risk
23% – % of Patients Showing Complete Response
8% – % of Patients Showing Partial Response
31% – % of Patients Showing Stable Disease
38% – % of Patients Showing Progressive Disease

2006 – Phase II

Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
Integr Cancer Ther. 2006 Mar;5(1):40-7

Brainstem glioma carries the worst prognosis of all malignancies of the brain

Most patients with brainstem glioma fail standard radiation therapy and chemotherapy and do not survive longer than 2 years

Treatment is even more challenging when an inoperable tumor is of high-grade pathology (HBSG)

patients with inoperable tumor of high-grade pathology (HBSG) treated with antineoplastons in 4 phase 2 trials

39% – overall survival at 2 years
22% – overall survival at 5 years

17+ years maximum survival for a patient with anaplastic astrocytoma

5+ years for a patient with glioblastoma

39% – Progression-free survival at 6 months

5+ year survival in recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem in a small group of patients

18 – evaluable
4 – glioblastomas
14 – anaplastic HBSG

14 – diffuse intrinsic tumors
12 – recurrence
6 – did not have radiation therapy or chemotherapy

Antineoplastons, A10 (A10I) and AS2-1 injections

5 months median duration

Responses were assessed by gadolinium-enhanced magnetic resonance imaging and positron emission tomography

Antineoplastons tolerated very well
1 case of grade 4 toxicity (reversible anemia)

2006 – Protocol – high-grade pathology (HBSG)
18 – Evaluable Patients
11% – % of Patients Showing Complete Response
11% – % of Patients Showing Partial Response
39% – % of Patients Showing Stable Disease
39% – % of Patients Showing Progressive Disease

2/24/2013
http://www.skeptical.gb.net/blog/?p=1442
2/27/2013
http://www.skeptical.gb.net/blog/?p=1798
3/9/2013
http://www.thetwentyfirstfloor.com/?p=8001

rjblaskiewicz:

Bobby, oh REALLY ?

β€œThe Skeptics” (Burzynski: Cancer is Serious Business, Part II)

The β€œgroup” β€œThe Sketics” claims is NOT a β€œgroup” and which allegedly does NOT spread β€œmisinformation”
https://stanislawrajmundburzynski.wordpress.com/2013/03/24/the-skeptics

rjblaskiewicz:

No Bobby, you did NOT

rjblaskiewicz:

“VAMPIRE” ?

rjblaskiewicz:

Bobby, like THIS ?

Stanislaw Rajmund Burzynski, M.D., Ph.D and β€œFreedom of Speech”

β€œThe most stringent protection of free speech would not protect a man in falsely shouting β€˜fire’ in a theater and causing a panic.”
United States Supreme Court ruled 3/3/1919
Schenck v. United States, 249 U.S. 47 (1919)

https://stanislawrajmundburzynski.wordpress.com/2013/03/24/stanislaw-rajmund-burzynski-m-d-ph-d-and-freedom-of-speech

rjblaskiewicz:

Bobby, like THIS ?

David H. Gorski and the Cult of β€œMISINFORMATION”

Colorado Public Television 12 – PBS: Part II
https://stanislawrajmundburzynski.wordpress.com/2013/03/10/david-h-gorski-and-the-cult-of-misinformation

Orac and the Cult of β€œMisinformation” (Part III)

David H. Gorski
https://stanislawrajmundburzynski.wordpress.com/2013/03/11/orac-and-the-cult-of-misinformation-part-iii

Josephine Jones and the Cult of Misinformation

JJ recently blogged:
https://stanislawrajmundburzynski.wordpress.com/2013/03/13/josephine-jones-and-the-cult-of-misinformation

Keir Liddle and the Cult of MISINFORMATION
https://stanislawrajmundburzynski.wordpress.com/2013/03/09/keir-liddle-and-the-cult-of-misinformation

The Cult of β€œMisinformation”

Review of β€œdisinformation,” β€œmisinformation,” and β€œmisdirection” posted by #Burzynski critics
https://stanislawrajmundburzynski.wordpress.com/2013/03/11/the-cult-of-misinformation

The cult of β€œMisinformation” continued

Adam Jacobs
https://stanislawrajmundburzynski.wordpress.com/2013/03/12/the-cult-of-misinformation-continued

rjblaskiewicz:

Bobby, where’s your

Citation(s),

Reference(s), and / or

Link(s) ?

rjblaskiewicz:

Bobby, Adam Jacobs does NOT care about “FREE SPEECH,” he censors it:
http://dianthus.co.uk/burzynski-qa

rjblaskiewicz:

Well, Bobby

We know a lot of the skeptics seem to “hate” the truth

rjblaskiewicz:

Bobby, maybe you should have actually watched THIS:

Burzynski Infomercial on Colorado PBS 12
http://www.skeptical.gb.net/blog/?p=2401

rjblaskiewicz:

Bobby, maybe you should ACTUALLY listen to it

rjblaskiewicz:

Yeah, riiiiiiiiight, Bobby

rjblaskiewicz:

“Response to the release of Burzynski 2, Havanna Nights”
http://t.co/t9WMpNRN9L

Skeptical Humanities
Learning is Cool

Response to the release of Burzynski 2, Havanna Nights

Posted by Bob

On this week’s episode of the Virtual Skeptics, I replied to what was learned at the premiere of the new Burzynski movie

The text of my segment follows the episode

This week, the new Burzynski movie premiered in San Luis Obispo, California

We largely knew what was going to be in the movie since a couple of trailers had been released, the patients who appeared had talked about the filming, and there was a sort of credulous review had appeared a few days ahead of time and I believe the director may have mentioned it on a PBS fundraising specual a few days earlier

So we had a pretty good idea of what our proxies should be looking for

We really wanted to see if certain people who had been filmed, like Amelia Saunders or Hannah Bradley appeared and especially what was said about them

We wanted lists of people who appeared, to see if we might be able to put together who said what

Most of these people’s stories are well known, and we doubted there would be anything new

Also our people took down key quotes that struck them as important, like

(those notes did NOT seem very “key” considering Orac’s (David H. Gorski @gorskon #sciencebasedmedicine @ScienceBasedMed @oracknows) “Second-Hand” “review” of Burzynski: Cancer is Serious Business, Part II)

“skeptics are hiding behind their BS free speech.”

(Yep, TRUE)

This is my takeaway, after talking to the people who I know were there

We are wiggly little scumbags who are hateful and slimy

(some skeptics seem to be “hateful” of the truth)

We ridicule the desperate and dying

Some of us are paid by big pharma

Others are deluded and think that we are doing good but are being misled

(that is a fair description of “misinformation,” “disinformation,” and “misdirection”)

But make no mistake–and this was hammered home to me by everyone I talked to–we are to them pure evil

One of my big concerns going into the movie was how I was going to be portrayed and whether or not I was going to receive death threats

That my family was going to receive death threats or that I was going to be harassed at work

I feared this because of a letter that, as you know, was sent to my employer promising that I would be featuring prominently in the Burzynski movie

Nobody asked me for my opinion or to give a statement or to respond or clarify; they went straight to my boss

Fine

I’ve had wacky people contact my employers in the past

I fully expect it to happen in the future

Clips of this show, episode 13, were included in the movie

This is the episode that was quoted in the letter on my university chancellor

As it turned out, our faces were blurred, our names obscured, and our voices were altered

No real identifying information

Which, you know, I’m OK with

However, there are some problems here

1) What was served by contacting my employer other than to scare me

How dare the filmmakers say that we’re terrorizing people when they are doing just that

2) Someone asked me about a quote,

β€œwe’re coming for you, you little polish sausage you.”

The thing is, the quote is patently absurd if my name is shown, something that everyone here jumped on, like I hoped you would during the original episode

That joking was not conveyed to the skeptics in the theater audience

This might be due to the fact that not only were we given scary voices but also that apparently every time we appeared scary music played in the background

It’s clear that the reason I’m in the movie in the capacity I am, as chief bad guy, is because I’m on video talking about the Burzynski Clinic

And this leads me to another thing that Brian mentioned

That when we kind of appeared on the screen, they put up a title card type thing that said,

“skeptical teleconference”

or something like that, and that a woman at the end of the show, wanted to know,

β€œHow did you get this footage of these scheming skeptics?”

Um….we publicize our show constantly?

If you can’t have real clandestine drama, you might as well make it up

My favorite bit was a tweet that I got around this time where a new account who followed like 10 people I do said,

“It’s really interesting when you talk about Burzynski on the show

Could you do that more?”

Really, Eric?

(Do you know it was Eric ? After all, you thought I was Eric)

Bob Blaskiewicz

Yeah, I have a feeling it’s Merola

That’s just me though

He’s way too invested in the hashtag in his movie to just let it drop
http://www.chapmancentral.co.uk/blahg/2013/03/burzynski-another-fact-blind-troll-who-predicted-that/#comments

Do you think I’m two years old?

(Your “fact-checking” ability makes me wonder)

I am interested in ultimately seeing it

I’m asking that the producer send a review copy to the James Randi Educational Foundation so a proper review can be done

(As if jref is a “reliable source”)

Or you could screen it in Minneapolis

Next week works for me, Eric, if you’re free

Another thing

News broke on the 7th of January in skeptical circles that the FDA was conducting an audit of the clinic

A patient in the movie apparently said that she had been receiving a brain scan when she heard that the Clinic was being investigated again

This means that material was added to the movie after the 7th of January

The Burzynski Birthday Fundraiser was announced by PZ Myers on the 6th

So there was more than enough time for the filmmaker to clarify exactly what was meant in that episode when I said that there was going to be a little present on his birthday

(That “present” PZ Myers was offering up ?)

Skeptics evilly, and with malice aforethought, raised $14.5K dollars for St. Jude’s

We then challenged the Clinic to match us, and it didn’t

That the director did not mention this fact seems to me inexcusable, making us look like we are big meanos who hate babies and morality

(He could have mentioned your “Fave,” PZ Myers)

This demonization is unfair and at the expense of the truth–if you ever read theotherburzynskipatientgroup blog you know whose side I’m on

If he used the video clip of us that he cited in his letter to my employer, about us bringing a β€œpresent” to Burzynski and knowing what it actually was without clarifying it, well, that just speaks to his regard for completeness and accuracy

No messiah should need such fudging

It suggests to me that he’s forcing evidence into a pre-existing narrative of persecution

(And what do you call what YOU are doing ?)

References:

PZ Myer’s announcement of the Houston Cancer Quack
http://scienceblogs.com/pharyngula/2013/01/06/lets-make-houston-cancer-quack-burzynski-pay/

The Virtual Skeptics episode that appears in the movie:

RJB

rjblaskiewicz:
http://t.co/F79zndTjuZ

Bob Blaskiewicz retweeted

Bobby, did you know that I tried to post a comment on the James Randi Educational Funding (jref) article Written by Brian Thompson , about this, but they did NOT post my response ?

Did you post something about “FREE SPEECH” ?

“Burzynski II” Fails to Convince
Swift”

http://www.randi.org/site/index.php/swift-blog/2050-qburzynski-iiq-is-more-of-the-same.html

My 1st-hand Review of Orac’s 2nd-Hand Review – Burzynski: Cancer is Serious Business, Part II

Burzynski critic Orac blogged about β€œBurzynski: Cancer is Serious Business, Part II”
https://stanislawrajmundburzynski.wordpress.com/2013/03/14/my-1st-hand-review-of-oracs-2nd-hand-review-burzynski-cancer-is-serious-business-part-ii

rjblaskiewicz:

Bobby, does this mean it will be punctuated correctly, but NOT “Fact-Checked” ?

rjblaskiewicz:

Bobby, it did NOT help

rjblaskiewicz:

rjblaskiewicz:

Not really. πŸ™‚

That’s what I thought, Bobby

rjblaskiewicz:

rjblaskiewicz:

rjblaskiewicz:

Bobby, what was that about

“many interesting and civil discussions” ?

Bobby, you can’t always get what you want

But if you try sometime, you just might find

you get what you need

rjblaskiewicz:

Bobby, let me guess

You are so busy tweeting about penises that you do NOT have enough time to “Fact-Check” ?

You do know FDA required ?

” … 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
http://www.sec.gov/Archives/edgar/data/724445/000091205702038660/a2091272z10qsb.txt

rjblaskiewicz:

Comes with the territory! πŸ™‚

Yes it does, Bobby

You’ve just been Insolently pwned