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”