Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 8)

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 1 week ago

“Erm, what conflict of interest?”

FW (also known as @frozenwarning), your “conflict of interest” with “facts”

Do you know how utterly, completely, fruit looping bonkers that is?

Seriously, get a grip.

FW 1 week ago

“Sadly Burzynski isn’t following FDA standards, as their warning letters and current inspection shut down proves.”

FW, being from the United Kingdom, are you even knowledgeable about the FDA warning letter process?

“He’s been doing his “research” for 40 years.”

“How long do you think he should be allowed to continue without showing his data?”

FW, what do you call THIS ?

Burzynski Clinical Trials (The SEC filings)
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2
“As I said earlier, the Phase 3 trial has been registered since 2010 and Burzynski shows no inclination to start it, having NOT A SINGLE PATIENT RECRUITED.”

FW, as I said earlier, did you pay attention to 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
Burzynski’s 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

” … 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”

why was the FDA requiring “radiation
” in the phase 3 clinical trial?

“I’ll tell you what these patients lose, they lose time, and quality of life, and hundreds of thousands of dollars on an unproven therapy that they are being misled about, and no-one in that situation deserves that.”

FW, isn’t EVERY drug in the clinical trial process “unproven therapy,” until such time as the FDA approves it?

Are you saying that because EVERY drug in the clinical trial process is “unproven therapy,” there should be NO clinical trials AT ALL?

FW 1 week ago

“Hah, if the FDA took any notice of the criticism, then I’m glad to hear it, though if Burzynski had not conducted his trials in an unethical and unscientific way, which was obvious merely from what his patients reported, they would have had no reason to shut his operation down.”

FW, what information do you have from the FDA that supports your comments?

“Why continue?”

“Well, there’s the so called gene targeted therapy that he still peddles for vast amounts of money, which isn’t gene targeted at all, merely a way of selling random scattergun, often off label chemotherapy.”

FW, where are your reliable independent sources (citation(s), reference(s), and / or link(s)?

“There are no retainers, that’s another of your usual batshit theories, used instead of answering the questions.”

FW, I’m still waiting for you to answer my questions

“Classy of you to use my family bereavements in such a way though.”

“I can assure you, they got the best care available and luckily no quack ever tried to con them. If they had, they would have got short shrift.”

FW, so, unfortunately, even though your family “got the best care available,” they still passed?

Which also happens to Burzynski

rjblaskiewicz 1 week ago

“Damn it, Eric. Wouldn’t your time be better spent recutting your movie so it didn’t suck?”

rjblatherskiewicz, I don’t see you on here with your lame comments:

Have you heard of Anthony Jeselnik’s “Defend Your Tweet?”

I’d like to find out how you’d “Defend Your Comments”

My Critique of Bob Blaskiewicz (Colorado Public Television – PBS CPT12)
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/my-critique-of-bob-blaskiewicz-colorado-public-television-pbs-cpt12
Critiquing Bob Blaskiewicz (#Burzynski Cancer is Serious Business, Part II)
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/critiquing-bob-blaskiewicz-burzynski-cancer-is-serious-business-part-ii
Boris Ogon 1 week ago

(citing Astroturfwatch’s comments):

“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.”

(Boris Ogon)

“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.”)”

Mr. Ogon, I don’t see any comments from “Merola” on the Forbes comments, but maybe you are referring to Astroturfwatch’s comments:

“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
(Boris Ogon)

“Let’s take them in turn, noting first that

“(1) neither represents the results of a completed Phase 2 trial and”

“(2) it’s essentially the same group in both.””

“We know the following about the ultimate group of 13:”

““Medulloblastoma was diagnosed in 8 patients, pineoblastoma in 3 patients, and other PNET in 2 patients.”

“Prior therapies included surgery in 12 patients (1 had biopsy only, suboccipital craniotomy), chemotherapy in 6 patients, and radiation therapy in 6 patients.”

“Six patients had not received chemotherapy or radiation.”

“The first reference is to Drugs in R&D 4:91 (2003).”

“This is a pharmacy journal, which immediately calls into question the adequacy of the available peer review.”

“It also appears to have briefly gone out of business, with no articles published in 2010.”

“Its JCR IF for 2009 was 1.354, which represented an increase of “more than 35%” of 2008; it did not even have an IF in 2011, but in this year, it was ranked 114 out of 221 in its SCImago category, *after* it had switched to “Gold OA,” which may well lead one to wonder whether it was even a third-tier journal earlier on.”

“The side effects included anemia, hypernatremia, agranulocytosis, and granulocytopenia.”

“End result?”

“The results of this study compared favourably with the responses of patients treated with radiation therapy and chemotherapy.”

“Color me unimpressed.”

“This gets better with the next one, though.”

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

“One may suspect from the title that we may have a problem here.”

“A look at the current editorial board leaves one distinctly unimpressed.”

“In particular, it includes *Ralph Moss.*”

“If this name doesn’t immediately set of a warning klaxon in your head, you’re not familiar with cancer crankery.”

“With a 2011 IF of 2.136, it currently ranks 118 of 196 in the JCR oncology category.”

“It shared this number with papers about acupuncture and green tea, but let’s cut to the chase:”

“The percentage of patients’ response is lower than for standard treatment of favorable PNET.”

“That’s right, “antineoplastons” did *worse* than standard treatment.”

“He tries to salvage something from this mess by suggesting that “antineoplastons” might someday prove useful for some categories of PNETs.”

“*Neither* paper claims superiority over conventional treatment.”

Mr. Ogon, where did you get your data from?

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

“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.””

Mr. Ogon, did you read THIS ?

Burzynski: STABLE DISEASE
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-stable-disease
5/2007 – Guidance for Industry – Food and Drug Administration
Guidance for Industry

Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics

U.S. Department of Health and Human Services Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

May 2007 Clinical/Medical

“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)”
(Pg. 11 of 22 = actual pg. 8 of PDF)

Time to Progression and Progression-Free Survival

TTP – Time to Progression

PFS – Progression-Free Survival

Time to Progression and Progression-Free Survival

TTP and PFS have served as primary endpoints for drug approval

TTP and PFS have served as primary endpoints for drug approval
(Pg. 11 of 22 = actual pg. 8 of PDF)

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.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)

http://www.ncbi.nlm.nih.gov/m/pubmed/15565574
St. Jude Children’s Research Hospital (Memphis, TN)
29 (88)
Texas Children’s Medical Center (Houston, TX)
2 (6)
Children’s Medical Center (Dallas, TX)
2 (6)
Cancer. 2005 Jan 1;103(1):133-9
Cancer 103, 133-139
Cancer Volume 103, Issue 1, pages 133–139, 1 January 2005
DOI: 10.1002/cncr.20741
Article first published online: 24 NOV 2004
American Cancer Society

http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/full
“Protip:”

“Before you start crying about how “‘fact-checking’ is no longer even on the table,” you might want to try figuring out what it actually is first.”

Mr. Ogon, what was that about

“fact-checking” ?

Lynne 1 week ago

“Angel of life, let me point out that there are many accounts of brain cancer survivors who were treated with conventional medicine.”

“Burzynski is not the only one.”

“A simple google search reveals that there are several cancer survivor groups and other accounts of healing via traditional scientific medicine.”

“Just one example:”

“virtualtrials.org”

“(go to the bottom of the page and click on survivor stories)”

“features 37 brain cancer patients who have survived from 5-30 years by choosing cutting edge research and clinical trials.”

“Their stories are identical to those of Burzynski patients.”

“Some people are just fortunate in their response to chemo, and make no mistake, Burzynski uses chemo.”

“There are a lot more examples out there.”

“Burzynski has not shown conclusively that he has a higher survival rate than conventional medicine, which would be so easy for him to do.”

Lynne, did you look HERE ?

Burzynski Clinical Trials (The SEC filings):
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2
“He could post it tomorrow; it doesn’t have to be in a peer reviewed journal.”

Lynne, at least you’re right about that:

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
“Instead, we are asked to just believe him because he’s such a nice guy who cares so much.”

Lynne, that’s one way to do it:

Burzynski: Declaration of Helsinki
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-declaration-of-helsinki
“To complete the equation, you have to know the denominator:”

Lynne, that’s another option:

Burzynski: FAQ: Clinical Trial Results
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-faq-clinical-trial-results/
“how many didn’t make it.”

Lynne, you could ask that too:

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
“Conventional medicine is transparent and reports failures.”

Lynne, if you say so, though you provide no citation(s), reference(s), and / or link(s):

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
“Burzynski doesn’t.”

Lynne, if you say so:

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
“Just another reason the body of scientists don’t find him credible.”

Lynne, like THESE ?

Burzynski referenced by other Cancer researchers:
https://stanislawrajmundburzynski.wordpress.com/2013/04/24/burzynski-referenced-by-other-cancer-researchers
Boris Ogon

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

3,799
views

Not so much

Waiting for the 10,000

4/19/2013 @ 9:43PM

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