Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 11)

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http://t.co/vh3cgAR6hW

http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics
Didymus Judas Thomas, Contributor

Musings on the intersection of Articles, Bias, and Censorship

(The Big 3: A.B.C.)

4/19/2013 @ 9:43PM

A Film Producer, A Cancer Doctor, And Their Critics

Allen Jones 1 day ago

“Interesting article.”

“Since there are two competing sides here I decided to do a bit of research on Burzynski and his treatment.”

“Success seems to be defined in terms of anecdotes only.”

“And after a continued search there seems to be just as many anecdotes of failures for this treatment.”

“Reading the website “the other Burzynski patient group” that outline all the heart wrenching failures of this treatment was difficult.”

“My conclusion is that this Burzynski is a quack of the lowest level.”

“Shameful!!!”

Allen Jones, I really can NOT adequately express how convincing your “alleged” “bit of research” sounds

Shameful!!!”???

claire G 1 day ago

@Guy Chapman,

(claire G, I really can NOT adequately express how convincing your use of @Guy Chapman is, considering as how “Guy Chapman” has gone by “guychapman” in all 18 of his “erudite” posts)

“It seems to me that actually the FDA are being very fair to Burzynski.”

claire G, please expand on how THIS is “the FDA” “being very fair to Burzynski.”

Click to access BurzynskiTriesToExposeNCI.pdf

“Despite the massive problems with hsi institutional review board, and his abject failure to publish results, they continued to allow him to register new trials.”

claire G, please expand on:

“they continued to allow him to register new trials.”

Exactly WHEN did “they continued to allow him to register new trials” “[d]espite the massive problems with hsi institutional review board”?

Please advise WHERE
“his abject failure to publish results”
was a condition for him “to register new trials.”

“I can’t think of anyone else in that position”.”

“You are so right.”

claire G, “you are so right”

“I can’t think of anyone else in that position”.

Exactly HOW are you going to answer THOSE questions?

“That cracking sound you hear is the FDA bending over backwards to accommodate Burzynski!”

claire G, please explain exactly HOW was the FDA requiring radiation in the phase 3 clinical trial, bending over backwards to accommodate Burzynski!”

Securities and Exchange Commission (SEC) Form 10-Q for the quarterly period ended 5/31/2010:

1/13/2009 Company announced Company had reached an agreement with FDA for Company to move forward with pivotal Phase III clinical trial of combination Antineoplaston therapy plus radiation therapy in patients with newly diagnosed, diffuse, intrinsic brainstem gliomas (DBSG)

Agreement was made under FDA’s Special Protocol Assessment procedure, meaning design and planned analysis of Phase III study is acceptable to support regulatory submission seeking new drug approval

2/1/2010 Company entered into agreement with Cycle Solutions, Inc., dba ResearchPoint to initiate and manage pivotal Phase III clinical trial of combination Antineoplastons A10 and AS2-1 plus radiation therapy (RT) in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma

ResearchPoint is currently conducting feasibility assessment

ResearchPoint has secured interest and commitment from number of sites selected

Upon completion of assessment, randomized, international phase III study will commence”

Study’s objective is to compare overall survival of children with newly-diagnosed DBSG who receive combination Antineoplastons A10 and AS2-1 plus RT versus RT alone

” … only obstacles now are $300 million $s needed to pay for final phase of clinical testing-and FDA requiring children with inoperable brainstem glioma to also undergo radiation
treatment in Phase 3 trials, claiming it would be “unethical” not to do so”

“For all the whining and complaining by Burzynski fans that he’s been so hounded and mistreated by the FDA,”

claire G, please pontificate on THIS:
http://stanislawrajmundburzynski.wiki-site.com/index.php/Main_Page
“I’ve never seen any doctor be allowed that much time and leeway to conduct clinical trials.”

claire G, please advise, what doctor has been allowed the next most “time and leeway to conduct clinical trials,” after Burzynski?

“The big question in many people’s minds is, WHY has Burzynski been given this special treatment?”

claire G, THIS “special treatment?

Antineoplastons: Has the FDA kept its promise to the American people ?:
https://stanislawrajmundburzynski.wordpress.com/2013/03/22/antineoplastons-has-the-fda-kept-its-promise-to-the-american-people
claire G, any questions NOW?

claire G 1 day ago

@AstroturfWatch,

“Antineoplastons are dead.

No more in the USA.

Only the rich, powerful, and the affluent who are “in the know” can get it now (no longer in the USA).”

“Ha!”

“So what you mean then is that nothing has really changed?”

claire G, are you indicating that antineoplastons were NOT available in the USA?

“It was always only either the very wealthy or those who could scrap together the $200,00.00 from donations who could afford antineoplastons.”

claire G, are you indicating that EVERY antineoplaston patient has had to “SCRAP together the $200,00.00”?

“By not publishing his research so that it could be peer reviewed and approved by the FDA Burzynski assured that antineoplastons would not be covered by insurance.”

claire G, please provide your citation(s), reference(s), and / or link(s) which support your:

“By not publishing his research so that it could be peer reviewed and approved by the FDA

Burzynski: What happens when a clinical trial is over?:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-what-happens-when-a-clinical-trial-is-over
National Cancer Institute (NCI) at the National Institutes of Health (NIH)

Cancer Clinical Trials

15. What happens when a clinical trial is over?

“The results of clinical trials are OFTEN published in peer-reviewed scientific journals”

” … WHETHER OR NOT the results are published in a peer-reviewed scientific journal … “
http://m.cancer.gov/topics/factsheets/clinical-trials
This makes it clear that clinical trial results “are OFTEN” published, but sometimes they are “NOT” published “in a peer-reviewed scientific journal”

Burzynski: FAQ: Clinical Trial Results
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-faq-clinical-trial-results/
Trial results are not always publicly available, even after a clinical trial ends

U.S. National Library of Medicine National Institutes of Health
http://www.nlm.nih.gov/services/ctresults.html
Burzynski: The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-the-fdas-drug-review-process-ensuring-drugs-are-safe-and-effective
“The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective”

“[T]he emphasis in Phase 2 is on EFFECTIVENESS”

“This phase aims to obtain PRELIMINARY DATA on whether the drug works in people who have a certain disease or condition”

“Phase 3 studies begin if EVIDENCE of EFFECTIVENESS is shown in Phase 2″

“These studies gather more information about safety and EFFECTIVENESS, studying different populations and different dosages and using the drug in combination with other drugs”
http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm
Burzynski: Declaration of Helsinki:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-declaration-of-helsinki
World Medical Association
http://www.wma.net/en/30publications/10policies/b3
PDF:

Click to access 17c.pdf

PDF:

Click to access 79(4)373.pdf

National Institutes of Health-HISTORY:

Click to access helsinki.pdf

The Declaration of Helsinki doesn’t indicate WHEN results MUST be published

“If you were sitting on this effective cure for cancers that affect children especially, wouldn’t you want to do whatever it took to make it available to anyone who needed it?”

claire G, ask the FDA

“Isn’t that what an ethical, caring, humanitarian would do?”

claire G, I refer you to the above

Boris Ogon

“You are right now having a live “debate” in front of more than 10,000 people, … “

Peter Lipson, Contributor
Musings on the intersection of science, medicine, and culture

3,932 views

Not so much

Waiting for the 10,000

Peter Lipson, Contributor

Musings on the intersection of science, medicine, and culture

4/19/2013 @ 9:43PM

Peter Lipson: “Speech is best countered by more speech”