Forbes Learns a Lesson, but Not the Right One: Censorship and Bias re: A Film Producer, A Cancer Doctor, And Their Critics

onforb.es/11pwse9
4/19/2013 @ 9:43PM
http://t.co/vh3cgAR6hW
“Speech is best countered by more speech”
http://www.forbes.com/sites/peterlipson/2013/04/19/a-film-producer-a-cancer-doctor-and-their-critics
Peter Lipson, Contributor

posted an article of a very dubious nature on Forbes (#Forbes), which censored (deleted) comments submitted and screen-captured as having been posted to the article comments section

What did Forbes do to rectify this embarrassing blunder?

Well, they did NOT do what Wikipedia is supposed to do (Do the RIGHT THING), they instead changed their comment acceptance function so that it now does NOT post the comments to the comment section; where they can be screen- saved to show that you submitted them, but now prevents the comments from being posted to the comments section before being reviewed by their censor(s)

I was able to submit comments and screen save them to show I submitted them, but the below, for example, was still censored

Thursday, 5/2/2013-ATTEMPT 1:

Didymus Thomas 30 minutes ago

Mr. Ogon, is this one of the Kurume, Japan case studies you were referring to?
Randomized Phase II Study of Hepatic Arterial Infusion with or without Antineoplastons as Adjuvant Therapy after Hepatectomy for liver Metastases from Colorectal Cancer. Annals of Oncology 2010;21:viii221

Reply

Didymus Thomas 20 minutes ago

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Didymus Thomas 4 hours ago

Mr. Ogon, you commented:
“One further has to take into account the fact that Scamley has been known to employ idiosyncratic definitions, such as classifying tumor *growth* as “STABLE DISEASE” for “less than 50% reduction in size but no more than 50% increase in size of the tumor mass, lasting for at least twelve weeks.””
FDA has advised:
5/2007 – “Guidance for Industry – Food and Drug Administration”
“Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics”
“”STABLE DISEASE should not be a component of ORR”
“STABLE DISEASE can reflect the natural history of disease””
(Pg. 10 of 22 = actual pg. 7 of PDF)
“…STABLE DISEASE can be more accurately assessed by TTP or PFS analysis (see below)”
“Also, STABLE DISEASE can be more accurately assessed by TTP or PFS analysis (see below)”
(Pg. 11 of 22 = actual pg. 8 of PDF)
“Time to Progression and Progression-Free Survival”
“TTP – Time to Progression”
“PFS – Progression-Free Survival”
“TTP and PFS have served as primary endpoints for drug approval”
(Pg. 11 of 22 = actual pg. 8 of PDF)
And in addition, the below 2005 non-Burzynski study also uses “STABLE DISEASE?”
Role of temozolomide after radiotherapy for newly diagnosed diffuse brainstem glioma in children
Results of a multiinstitutional study (SJHG-98)

Reply

Didymus Thomas 15 minutes ago

Mr. Chapman, you commented:
” … the failure to publish any usable results from any single trial is grossly unethical”
“ The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective” advises:
“[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”

Reply

Didymus Thomas 9 minutes ago

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

Reply

Didymus Thomas 1 minute ago

2003-2006 phase II clinical trial preliminary reports.
The co-authors might include an oncologist:
Drugs R D.
2003;4(2):91-101
2004;5(6):315-26
Integr Cancer Ther.
2005 Jun;4(2):168-77
2006 Mar;5(1):40-7

Friday, 5/3/2013-ATTEMPT 2

(Note how I shortened the comment):

Thank you for submitting your comment:

New comments typically appear within 30 seconds.

Mr. Ogon, 5/2007 – “Guidance for Industry – Food and Drug Administration”
“Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics”
“Stable disease can reflect the natural history of disease”
“Also, stable disease can be more accurately assessed by TTP or PFS analysis”
“TTP – Time to Progression”
“PFS – Progression-Free Survival”
“TTP and PFS have served as primary endpoints for drug approval”
The below study also uses “stable disease”
Cancer. 2005 Jan 1;103(1):133-9 DOI: 10.1002/cncr.20741

Share your comment:

Saturday, 5/4/2013-ATTEMPT 3

Note how I further shortened the comment):

Thank you for submitting your comment:

New comments typically appear within 30 seconds.

Mr. Ogon, 5/2007 – “Guidance for Industry – Food and Drug Administration, Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics:” “Stable disease can reflect the natural history of disease”
This study uses “stable disease:”. Cancer. 2005 Jan 1;103(1):133-9 DOI: 10.1002/cncr.20741

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Forbes posted the 1 below comment out of the above:

Didymus Thomas 3 days ago
Mr. Ogon, is this one of the Kurume, Japan case studies you were referring to?
Randomized Phase II Study of Hepatic Arterial Infusion with or without Antineoplastons as Adjuvant Therapy after Hepatectomy for liver Metastases from Colorectal Cancer. Annals of Oncology 2010;21:viii221

One would hope that Forbes would learn a lesson about censoring individual’s comments, but instead, it seems that they learned a lesson about how to block comments

Here is the BIAS exhibited by Forbes, as far as whose comments they did NOT “censor”

– = “The Skeptic” Critics
+ = Questioning “The Skeptic” Critics

– = 70
+ = 44

+ = 25 more

(pg. 1)

rjblaskiewicz –
guychapman –
Peter Lipson –
rjblaskiewicz –
Vered Yasur –
Angel of Life +
rjblaskiewicz –
guychapman –
guychapman –
Krista Cashatt +

(pg. 2)

Boris Ogon –
junkeeroo +
Boris Ogon –
Sarah
junkeeroo +
junkeeroo +
Boris Ogon –
rjblaskiewicz –
Kendra Sue Too +
Boris Ogon –

(pg. 3)

junkeeroo +
Boris Ogon –
junkeeroo +
guychapman –
FW –
Angel of Life +
rjblaskiewicz –
randy hinton +
Boris Ogon –
rjblaskiewicz –

(pg. 4)

lilady –
Vered Yasur –
junkeeroo +
Tina Patterson +
chriswinter +
guychapman –
Angel of Life +
Boris Ogon –
JGC2013 –
guychapman –

(pg. 5)

lilady –
Angel of Life +
Boris Ogon –
FW –
junkeeroo +
Angel of Life +
Peter Lipson –
Angel of Life +
junkeeroo +
Boris Ogon –

(pg. 6)

Paul Morgan –
guychapman –
JGC2013 –
junkeeroo +
FW –
junkeeroo +
rjblaskiewicz –
FW –
Angel of Life +
Angel of Life +

(pg. 7)

Angel of Life +
FW –
AstroturfWatch +
FW –
junkeeroo +
junkeeroo +
Angel of Life +
Peter Lipson –
AstroturfWatch +
AstroturfWatch +

(pg. 8)

FW –
AstroturfWatch +
Angel of Life +
FW –
FW –
AstroturfWatch +
FW –
rjblaskiewicz –
Boris Ogon –
Boris Ogon –

(pg. 9)

Lynne –
guychapman –
guychapman –
guychapman –
guychapman –
randy hinton +
guychapman –
Boris Ogon –
Boris Ogon –
guychapman –

(pg. 10)

guychapman –
randy hinton +
guychapman –
Sharon Hill –
oval wooki –
randy hinton +
guychapman –
JGC2013 –
guychapman –
AstroturfWatch +

(pg. 11)

guychapman –
Allen Jones –
claire G –
claire G –
randy hinton +
lilady –
Didymus Thomas +
lilady –
Didymus Thomas +
lilady –

(pg. 12)

Didymus Thomas +
lilady –
Didymus Thomas +
Didymus Thomas +
Didymus Thomas +
Didymus Thomas +

“The Skeptic” Critics
TOTAL
18-guychapman –
13-Boris Ogon –
10-FW –
_8-rjblaskiewicz –
_6-lilady –
_3-Peter Lipson –
_3-JGC2013 –
_2-claire G –
_2-Vered Yasur –
_1-Paul Morgan –
_1-Lynne –
_1-Sharon Hill –
_1-oval wooki –
_1-Allen Jones –
70-TOTAL

Questioning “The Skeptic” Critics
TOTAL
12-junkeeroo +
10-Angel of Life +
_7-Didymus Thomas +
_6-AstroturfWatch +
_5-randy hinton +
_1-Krista Cashatt +
_1-Kendra Sue Too +
_1-Tina Patterson +
_1-chriswinter +
44-TOTAL

_1-Sarah (neutral)

“The Skeptic” Critics

guychapman (Guy Chapman, @SceptiGuy, @vGuyUK)
http://www.chapmancentral.co.uk/blahg/
A United Kingdom (UK) blahg

Guy Chapman comments on “Orac’s”:
(http://www.scienceblogs.com/Insolence)

FW (@frozenwarning): I work for the NHS in the UK

frozenwarning comments on “Orac’s”:
(http://www.scienceblogs.com/Insolence)

rjblaskiewicz (Bob Blaskiewicz, R.J. Blaskiewicz, @rjblaskiewicz)
http://www.skepticalhumanities.com

Bob Blaskiewicz comments on “Orac’s”:
(http://www.scienceblogs.com/Insolence)

lilady comments on “Orac’s”:
(http://www.scienceblogs.com/Insolence)

Peter Lipson (@palMD)
http://www.sciencebasedmedicine.org

http://www.sciencebasedmedicine.org/index.php/author/palmd/

http://www.sciencebasedmedicine.org/index.php/editorial-staff/peter-a-lipson-md/

Dr. David H. Gorski (“Orac,” @gorskon, @oracknows, @ScienceBasedMed, #sciencebasedmedicine
runs:
http://www.scienceblogs/Insolence
and is the editor of:
http://www.sciencebasedmedicine.org
and is a “pal” of his “bud:”. Dr. Peter A. Lipson)

Paul Morgan (@drpaulmorgan)

Paul Morgan comments on “Orac’s”:
(http://www.scienceblogs.com/Insolence)

What do all of those “Skeptic” Critics have in common?

Dr. David H. Gorski (“Orac”)

Forbes censors Peter Lipson “Speech is best countered by more speech” article comments:
https://stanislawrajmundburzynski.wordpress.com/2013/04/23/forbes-censors-peter-lipson-speech-is-best-countered-by-more-speech-article-comments/

Boris Ogon (@borisogon)

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

3,921 views

Not so much

Waiting for the 10,000

4/19/2013 @ 9:43PM

A Film Producer, A Cancer Doctor, And Their Critics

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

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guychapman (Guy Chapman) Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 9)

onforb.es/11pwse9

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

guychapman 5 days ago

“Well, this has flushed out i the comments most of what we’ve seen on Twitter and the blogs over the past year or two.”

guychapman, hardly
redd.it/1czvol
Forbes censors Peter Lipson
http://redd.it/1czvol
“Speech is best countered by more
http://www.reddit.com/tb/1czvol
speech” article comments:
https://stanislawrajmundburzynski.wordpress.com/2013/04/23/forbes-censors-peter-lipson-speech-is-best-countered-by-more-speech-article-comments
"On the one side we have the true believers claiming that there is a cure, that it’s being denied, that people would “otherwise die” (begging the question), and asking for “respect” and “decency”"

guychapman, THIS cure ?
http://burzynskimovie.com/images/stories/transcript/Documents/BurzynskiTriesToExposeNCI.pdf
"(as if it is respectful and decent to claim to cure cancer without good evidence)."

guychapman, THIS “good evidence” that you’re “without” ?

Burzynski – The Antineoplaston Randomized Japan Phase II Clinical Trial Study:
https://stanislawrajmundburzynski.wordpress.com/2013/03/28/burzynski-the-antineoplaston-randomized-japan-phase-ii-clinical-trial-study
"On the other side we have one really very simple point: show me the evidence."

guychapman, THIS “good evidence” that you’re “without” ?

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
“61 registered human trials, one completed, zero results published, from any of them.”

guychapman, do you mean THIS ?

clinicaltrials . gov does NOT contain the same data as the National Cancer Institute (NCI) at the National Institutes of Health (NIH) cancer . gov web-site:

61 TOTAL
1 – Not Yet Recruiting (Open)(Phase 3)
1 – Closed
2 – Terminated (Withdrawn due to slow enrollment)
7 – Withdrawn (This study has been withdrawn prior to enrollment)
10 – Recruiting (Open)
11 – Open (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)

The below 1st link: 10 Active (Open):
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11475951
The below 2nd link: 25 Closed-1st screen / 15 Closed-1 Completed-2nd screen:
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11476036
NONE of the above are “UNKNOWN” per the above 2 National Cancer Institute (NCI) at the National Institutes of Health (NIH) links:

10 – Recruiting (Open)
11 – Open (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)

10=Open
11=1 Not Yet Recruiting / 10 Recruiting
40=Closed
61-TOTAL

“The Burzynski fans’ snowstorm of irrelevant, low-grade publications in low impact journals and conference abstracts that aren’t even peer-reviewed, do not address this at all.”

guychapman, are you referring to THIS ?

The “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”

“The Helsinki Declaration states the obligations of those conducting trials in humans, and getting the results (good or bad) published and available is a core requirement.”

guychapman, WHERE does the Declaration of Helsinki indicate WHEN the final results of human clinical trials MUST be published?

Burzynski: Declaration of Helsinki
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-declaration-of-helsinki
guychapman 5 days ago

“I have some questions for the Burzynski fans.”

guychapman, I have some questions for you

Is it just me, or does it seem like I’m repeating what I already provided HERE?

Critiquing “The Skeptic”
redd.it/1do1ah
Burzynski Critics: A Film
http://redd.it/1do1ah
Producer, A Cancer
http://www.reddit.com/tb/1do1ah
Doctor, And Their Critics (page 9)
https://stanislawrajmundburzynski.wordpress.com/2013/05/04/critiquing-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics-page-9/
“1. Burzynski’s claims are superficially similar to those of Max Gerson.”

“Gerson’s therapy is known to be ineffective and potentially harmful, but he used patient anecdotes – people sincerely convinced they had undergone a miracle cure – to promote his business.”

“What *objective* mechanism do you propose we use to distinguish between Burzynski and the quack Gerson?”

guychapman, how about the publications and Securities and Exchange (SEC) filings cited on my page 9 critique?

“2. Burzynski has registered 61 clinical trials in humans, completed one and published no useful data from any.”

guychapman, you obviously have a very “fast and loose” definition of “no useful data”

Exactly WHAT is your definition of “no useful data”?

“Can you name any mainstream cancer research operations that have similar rates of failure to compete and publish?”

guychapman, can you name any mainstream publications like Forbes that have similar rates of failure to “compete” and publish my 15+ comments in reply to your 18 comments?

Do you think it was because they knew that I would “rip you a new one” and you would be left there as the proverbial “Emperor (who) has no clothes”?

“3. How many people do you estimate are involved, globally, in the conspiracy to suppress Burzynski’s treatment?”

“My rough guess is a few hundred thousand.”

“Can you give a better estimate with reasons?”

guychapman, let’s start with YOU, guychapman (Guy Chapman, @SceptiGuy, @vGuyUK,
http://www.chapmancentral.co.uk/blahg),
your pals at Wikipedia; Jimmy (Jimbo) Donal Wales,
http://www.jimmywales.com,
(@jimmy_wales – whom you re-twit on Twitter), JzG|Guy, Guy, Anthony (AGK) BASC, Alexbrn, Dave Dial, Drmies, NE Ent, fluffernutter, foxj, jpgordon, Guerillero, Ironholds, John, Lord Sjones23, Tom Morris, Nstrauss, Steve Pereira/SilkTork, Rhode Island Red, Arthur Rubin, Choyoołʼįįhí:Seb az86556 (Seb az86556), Sgerbic, IRWolfie, Six words, Yobol, @RudyHellzapop, @_JosephineJones, @JCmacc1, @Malboury, @DianthusMed, @medTek, @StopBurzynski, @StortSkeptic, Dr. Peter A. Lipson (@palMD), #Forbes censor(s), Dr. David H. Gorski (@gorskon, @oracknows, @ScienceBasedMed, #sciencebasedmedicine,
http://www.scienceblogs.com/Insolence,
http://www.sciencebasedmedicine.org,
The Faux Skeptic Revealed! Bob Blaskiewicz (@rjblaskiewicz, R.J. Blaskiewicz, Blatherskitewicz), C0nc0rdance, Boris Ogon, lilady, JGC2013, claire G, Sharon Hill, Allen Jones, Lynne, @JCmacc1, Paul Morgan (@drpaulmorgan), oval wooki, Vered Yasur, (the Forbes group) and
http://burzynskimovie.com/images/stories/transcript/Documents/BurzynskiTriesToExposeNCI.pdf, etc.

“4. When you talk about Antineoplastons not being chemotherapy, what, in your mind, distinguishes the intravenous administration of one chemical from the intravenous administration of another, other than the fact that it’s Burzynski doing it?”

guychapman, THIS:

“High Dose ANPA chemotherapy IV drip”

“…an unapproved drug, not ordinary “chemotherapy”
https://bulk.resource.org/courts.gov/c/F3/27/27.F3d.153.93-2071.html
“5. When you speak about ANPs not being toxic, what, in your mind, distinguishes the side effects of “non-toxic” ANPs”

“(nausea, hypernatraemia, stroke etc)”

“form the side effects of other, “toxic” drugs?”

guychapman, THIS:

Burzynski: HYPERNATREMIA:
https://stanislawrajmundburzynski.wordpress.com/2013/04/24/burzynski-hypernatremia
FACT: Is “HYPERNATREMIA” listed on the National Cancer Institute (NCI) at the National Institutes of Health (NIH) list as a possible “Adverse Effect” of antineoplastons?:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page6
I do NOT see HYPERNATREMIA or STROKE on the list

2/13/2013 – The frequency, cost, and clinical outcomes of HYPERNATREMIA in patients hospitalized to a comprehensive CANCER center
http://www.ncbi.nlm.nih.gov/m/pubmed/23404230
Over 3 month period in 2006 re 3,446 patients, most of the HYPERNATREMIA (90 %) was acquired during hospital stay

Division of Internal Medicine, UT MD Anderson Cancer Center, Houston, TX, USA

Department of General Internal Medicine, University of Texas MD Anderson Cancer Center

Division of Endocrinology, Mayo Clinic

Support Care Cancer. 2013 Feb 13. [Epub ahead of print]

Supportive Care in Cancer
February 2013

DOI
10.1007/s00520-013-1734-6
http://link.springer.com/article/10.1007%2Fs00520-013-1734-6
HYPERNATREMIA in the U.S.:

“HYPERNATREMIA is the most common electrolyte disorder in the United States”

“In some cases, CANCER may cause the condition …”
http://www.nlm.nih.gov/medlineplus/ency/article/000394.htm
“A Burzynski critic has posted:”

“In order to maintain their doses of ANP, patients are required to drink obscene amounts of water every day (some report up to 12 quarts or more)”

“If they fail to do so, they may lapse into unconsciousness or die”

Let’s put this in perspective

FACT: Some sources indicate:

1) A man should drink about
3 liters (101.44 ounces / 3 quarts 5.44 ounces) per day

{12 quarts = 384 ounces = 11.356 liters}

[12 quarts in 24 hours = 1/2 quart or 16 ounces per hour]

2) Extremely healthy kidneys could process about 30 ounces (approx .9 liters) of water in an hour

{30 ounces in 24 hours = 720 ounces}

[720 ounces = 22.5 quarts per day]

3) A person with healthy kidneys could develop water intoxication by drinking about 2 to 3 times what their kidneys can process

So, if extremely healthy kidneys could process about 30 ounces per hour and 12 quarts per day would require one to only drink 16 ounces per hour, that means one is being asked to drink 14 ounces less per hour than what extremely healthy kidneys could process

So even if one drinks more than 16 ounces per hour so that one does not have to be awake hourly, there is still opportunity to do that

Of course, there are certain other factors that might have to be taken into consideration depending on the patient

“6. Burzynski has convinced you that he can cure incurable cancers.”

“What figures has he given you for his five-year survival versus standard of care?”

guychapman, HERE:

2003 – 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

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

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

2004 – 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

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

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

2004
Protocol – incurable recurrent and progressive multicentric glioma
12 – Patients Accrued
– Evaluable Patients
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 – 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
– Patients Accrued
– Evaluable Patients
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 – 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

22% – overall survival at 5 years

17+ years maximum survival for a patient with anaplastic astrocytoma

5+ years for a patient with glioblastoma

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

18 – evaluable

2006
Protocol – high-grade pathology (HBSG)
– Patients Accrued
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

2007 – Recent clinical trials in diffuse intrinsic brainstem glioma

Review Article
http://www.cancer-therapy.org/CT/v5/B/HTML/42._Burzynski,_379-390.html
Cancer Therapy Vol 5, 379-390, 2007

(Forbes)

Boris Ogon 1 week ago

(citing AstroturfWatch)

“They refuse to fact check anything. Namely Phase 2 results showing a 25% cure rate for brainstem glioma, never accomplished in medical history—ever.”

“Published plan as day in a ‘internationally peer-reviewed’ article.”

“You mean PMIDs 12718563 and 16484713? (These, at least, are the ones that Merola cites, which I assume is the sum total of your “fact checking.”)”

“Namely Phase 2 results showing a 25% cure rate for brainstem glioma, never accomplished in medical history—ever”

“Notice the chart on page 172 (page 8 of PDF).”

“Find just one, any single cure for this tumor type and you can’t, outside of Antineoplastons FDA sanctioned clinical trials:”
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf
“The first reference is to Drugs in R&D 4:91 (2003).”

“The second reference is to Integrative Cancer Therapies 4:168 (2005).”

The “chart on page 172 (page 8 of PDF):”
http://www.burzynskiclinic.com/images/stories/Publications/1252.pdf
refers to:

2006 Adis – Pediatr Drugs 2006; 8 (3)

pg 172

Treatments for Astrocytic Tumors

Table II. Treatment of diffuse, intrinsic brainstem glioma in children

Burzynski et al. [88] – Reference
Phase II – Study Type
(no. of pts) – pts = patients
RP (30) – RP = recurrent and progressive tumor – Tumor type
ANP – ANP = antineoplastons A10 and AS2-1 – Treatment – ANP
OS (%) – OS = overall survival
[2y; 5y]
46.7; 30 – Efficacy
MST (mo)
19.9 – MST = median survival time
[% (no. )]
27 (8) – CR – CR = complete response
[% (no. )]
20% (6) – PR – PR = partial response
[% (no. )]
23% (7) – SD – SD = stabile disease
30% (9) – PD = progressive disease

pg 177

88. Burzynski SR, Weaver RA, Janicki T. Long-term survival in phase II studies of antineoplastons A10 and AS2-1 (ANP) in patients with diffuse intrinsic brain stem glioma [abstract]. Neuro-oncol 2004; 6: 386

This is the 2004 publication, NOT 2003

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

pg 172

Burzynski et al. [89] – Reference
Phase II – Study Type
(no. of pts) – pts = patients
RPS (10) – RPS = recurrent and progressive tumors in children aged <4y – Tumor type {(66) = most in a study}
ANP – ANP = antineoplastons A10 and AS2-1 – Treatment – ANP
OS (%) – OS = overall survival
[2y; 5y] – Efficacy
60; 20 {46.7 (30) = next best study}
MST (mo)
26.3 – MST = median survival time – {19.9 = next best study}
[% (no. )]
30% (3) – CR = complete response – {27% (8) = next best study}
[% (no. )]
0% (0) – PR = partial response – {56% (1) = next best}
[% (no. )]
40% (4) – SD = stable disease – {44% (25) = best}
[% (no. )]
30% (3) – PD = progressive disease – {23% (13) = best}

(Above, I also provide the best next case to compare to)

pg 177

89. Burzynski SR, Weaver RA, Janicki TJ, et al. Targeted therapy with ANP in children less than 4 years old with inoperable brain stem gliomas [abstract]. Neuro-oncol 2005; 7: 300

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

pg 173

1.4.3 Targeted Therapy

“…multi-targeted therapy with ANP has shown promising results [12;88-91]”

pg 176

90. Burzynski SR, Lewy RI, Weaver RA, et al. Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma: a preliminary report. Drugs R D 2003; 4: 91-101

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

91. Burzynski SR, Weaver RA, Janicki T. et al. Targeted therapy with antineoplastons A10 and AS2-1 (ANP) of high-grade, recurrent and progressive brain stem glioma. Integr Cancer Ther 2006 Mar; 5 (1): 40-7

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

30 evaluable patients with recurrent and progressive DBSG

“>40% of patients survived for more than 2 years
30% more than 5 years.”

27% – CR – Complete Response
20% – PR – Partial Response
23% – SD – Stable Disease
30% – PD – Progressive Disease
[12,88]

pg 175

12. Burzynski SR Targeted therapy for brain tumors In: Columbus, F editor. Brain cancer research progress. New York: Nova Science Publishers Inc 2005

pg 173

10 evaluable children
aged <4 years diagnosed with DBSG treated with ANP
youngest 3-month-old infant
[89]

60% – 2-year survival rate
20% – 5-year survival rate
maximum survival more than 7 years

30% – CR – Complete Response
40% – SD – Stable Disease
30% – PD – Progressive Disease
[89]

“The results are compiled in table II.”

pg 174

2.3. Targeted Therapy

Multi-targeted ANP therapy is free from chronic toxicity in children and adults based on the results of numerous clinical studies involving

1652 adults
335 children
[147]

pg 178

147. Burzynski SR. Annual report to the FDA, IND 43,742, 2006

pg 174

Long-term follow-up of children treated with ANP for astrocytomas revealed:
normal development
no cognitive or endocrine deficiencies
normal fertility

>5 years – substantial number of patients tumor free
>17 years – follow-up period for some patients

pg 169

1.1.4. Targeted Therapy

Clinical trials with agents affecting single targets are in progress and the preliminary results of multi-targeted therapy with
antineoplastons (ANP) A10
and
AS2-1 have been reported
[39]

small group of patients with progressive LGA, ANP
60% – CR rate – Complete Response
10% – PR rate – Partial Response
median survival 7 years 9 months
maximum survival of more than 15 years
[39]

LGA = Low-Grade Astrocytomas

Table I. Selected chemotherapy regimens for the treatment of low- grade astrocytoma in children

Burzynski [39] – Reference
Phase II d – d = Preliminary results – Study type
P – P = progressive tumor – Tumor type
(no. of pts) – pts = patients
ANP (10) – ANP = antineoplastons A10 and AS2-1 – Treatment {(78) = most in a study}
OS [%] – OS = overall survival
100% (1 yr) – 90% (3 yr) – Efficacy
93 mo – MST = MST = median survival time – {96 (1 y) next closest}
CR [% (no.)]
60% (6) – CR = complete response {24 (11) next closest}
PR [% (no.)]
10% (1) – PR = partial response {60% (9) best other study}
[% (no.)]
30% (3) – SD = stable disease + MR = minor response {70% (14) best other study}
[% (no.)]
0% (0) – PD = progressive disease {4% (2) next closest}
PFS (%)
90 (1 y) – 90 (3 y) – PFS = progression-free survival {100 (1 y) – 68 (3 y) best other study

(Above, I also provide the best next case to compare to)

pg 176

39. Burzynski SR Clinical application of body epigenetic system: multi-targeted therapy for primary brain tumors. World and Ehrlich Conference on Dosing of Magic Bullets; 2004 Sep 9-11 Nurnberg

Burzynski Clinical Trials (The SEC filings):
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2
Who has audited these figures?

guychapman, YOU just did

Otherwise, check with the Food and Drug Administration (FDA)

Where are they published?

guychapman, if you have NOT yet figured THAT out…

“7. There are numerous cases where the Burzynski clinic has said a tumour is “dying from the inside”, but where it turns out that it is growing aggressively and suffering necrosis due to outstripping its blood supply; this is usually a precursor to the death of a patient only weeks after being told they were on the way to a cure.”

“How do you account for this repeated error?”

guychapman, WHERE is the documentation?

Boris Ogon

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

3,919 views

Not so much

Waiting for the 10,000

4/19/2013 @ 9:43PM

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

Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 5)

http://t.co/vh3cgAR6hW

onforb.es/11pwse9

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

FW 6 days ago

“Ah, the usual Burzynski conspiracy theorists are here.”

“As usual, not a single one of the valid criticisms are addressed.”

FW (also known as @frozenwarning)

It’s difficult to address any “allegedly” valid criticisms when Forbes’ censors are blocking (deleting) them

Dr. Peter A. Lipson (and / or his Censor(s)) is a Coward: Critiquing “A Film Producer, A Cancer Doctor, And Their Critics”
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/dr-peter-a-lipson-and-or-his-censors-is-a-coward-critiquing-a-film-producer-a-cancer-doctor-and-their-critics
“Time for this man to be stopped, 40 years is more than long enough to have produced the results of his numerous, badly run trials.”

FW, what year did Burzynski start clinical trials?

Because it sounds like you do NOT know what you’re talking about

Burzynski Clinical Trials (The SEC filings)
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2
“Patients are free to choose whatever treatment they like, but that choice should be informed and sellers of miracle cures must not be allowed to mislead those patients.”

frozenwarning, NO, patients are NOT free to choose whatever treatment they like:

Burzynski: United States Supreme Court:
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-united-states-supreme-court
Boris Ogon 6 days ago

“Scamley, however, is able to offer phenylbutyrate (which is all “antineoplastons” actually come down to) and his hopelessly incompetent “gene-targeted therapy” to anyone who’s willing to shell out.”

Mr. Ogon, PHENYLBUTYRATE (PB)is NOT (all “antineoplastons” actually come down to):

Antineoplastons AS2-1 and AS2-5 are DERIVED FROM A10

PHENYLACETYLGLUTAMINATE (PAG or PG) and PHENYLACETATE (PN) are metabolites of PHENYLBUTYRATE (PB) and are constituents of antineoplaston AS2-1

AS2-1=4:1 mixture of PHENYLACETIC ACID (PA) and PHENYLACETYLGLUTAMINE (PAG or PG)

Antineoplaston AS2-5=PHENYLACETYLGLUTAMINE (PAG or PG)

Paul Morgan 5 days ago

“Perhaps you would be so kind as to link to where the 61 registered clinical trials by Burzynski are published?”

“Oh…… you can’t.”

Mr. Morgan:

The “National Cancer Institute (NCI) at the National Institutes of Health (NIH)

Cancer Clinical Trials

15. What happens when a clinical trial is over?

advises:

“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”

“Let’s just stick to simple, verifiable facts here.”

“Stansislaw Burzynski, the Burzynski Clinic and Burzynski Research Institute have 61 clinical trials registered.”

“The list is available here.”
http://clinicaltrials.gov/ct2/results?term=antineoplaston&Search=Search
“You will note that only ONE trial has ever been completed.”

“By anyone’s standard, that is an appallingly low completion rate.”

“The results have never been published anywhere.”

Mr. Morgan, what YEAR was that “ONE trial” completed?

“No doubt Burzynski and his cronies will continue to spin the line that he’s submitted to journals but they’ve blocked him, when the more likely scenarios are any papers submitted have been rejected due to poor science or there haven’t been any journal submissions.”

“If there have been any journal submissions, there will be a correspondence chain, either emails or paper letters.”

“It would be simple enough for Burzynski to publish them on his website or on a service such as Google Docs.”

Mr. Morgan, have you looked here?

Burzynski Clinical Trials (The SEC filings)
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2
“The single registered Phase 3 trial was never started and – it seems from the Clinic’s own website – seems to have quietly been “forgotten” by them.”

Mr. Morgan, did you know this?

Burzynski: Not every cancer clinical trial taking place in the United States is listed on our NCI clinical trials database
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-not-every-cancer-clinical-trial-taking-place-in-the-united-states-is-listed-on-our-nci-clinical-trials-database
“As for the remaining 59 trials, we can see that 50 have status “unknown”, 2 are “termiinated” and 7 “withdrawn”.”

Mr. Morgan, did you know this?

The “FACT” one should know is that clinicaltrials . gov does NOT contain the same data as the National Cancer Institute (NCI) at the National Institutes of Health (NIH) cancer . gov web-site:

61 TOTAL
1 – Not Yet Recruiting (Open)(Phase 3)
1 – Closed
2 – Terminated (Withdrawn due to slow enrollment)
7 – Withdrawn (This study has been withdrawn prior to enrollment)
10 – Recruiting (Open)
11 – Open (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)

The below 1st link: 10 Active (Open):
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11475951
The below 2nd link: 25 Closed-1st screen / 15 Closed-1 Completed-2nd screen:
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11476036
NONE of the above are “UNKNOWN” per the above 2 National Cancer Institute (NCI) at the National Institutes of Health (NIH) links:

10 – Recruiting (Open)
11 – Open (1 Not Yet Recruiting / 10 Recruiting)
40 – Active, not recruiting (Closed)

10=Open
11=1 Not Yet Recruiting / 10 Recruiting
40=Closed
61-TOTAL

“These trials have been running (allegedly) for many years.”

“These are the plain facts of the matter.”

Mr. Morgan, when does the Declaration of Helsinki indicate that the final results of human clinical trials must be published?

Burzynski: Declaration of Helsinki
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-declaration-of-helsinki

“No matter how you try to play it, the simple fact is that there is no published evidence of benefit for antineoplastons, either from Burzynski or anyone else – the Japanese stuff from Kurume is no more than a few case reports.”

Mr. Morgan, is this one of those case reports?

Burzynski – The Antineoplaston Randomized Japan Phase II Clinical Trial Study
https://stanislawrajmundburzynski.wordpress.com/2013/03/28/burzynski-the-antineoplaston-randomized-japan-phase-ii-clinical-trial-study
“If you actually analyse what Burzynski has actually published, it’s a bunch of reports of laboratory work, a mish-mash of case reports and a jumbled-up mixture of preliminary results of mixed-up trials presented as posters at various conferences.”

“Poster presentations prove nothing – they are the lowest form of publication, usually used as a means of presenting preliminary thoughts and ideas, not as proof of efficacy of a therapy.”

“Given that BUrzynski has been researching antineoplastons since he arrived in the USA in 1970 and he first used the term antineoplaston in a publication in 1976 (check out his CV on his website), it’s pretty poor to consider poster presentations of preliminary results as being of any merit whatsoever!”

“Typically, Burzynski supporters will point to the volume of publications but completely fail to grasp the issue of quality.”

“Essentially, Burzynski has been researching antineoplastons for more than 35 years as has failed abjectly to provide any evidence of benefit for their efficacy.”

Mr. Morgan, do you know when the clinical trials were completed?

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
“Game over.”

Mr. Morgan, really?
http://www.china-burzynski.com

http://www.china-burzynski.com/lczl/bingrengushi_135135.html

http://www.china-burzynski.com/lxwm
Boris Ogon

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

3,778 views

Not so much

Waiting for the 10,000

| 4/19/2013 @ 9:43PM

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