The Skeptics™” Robert J. (don’t call me “Bobby”) Blaskiewicz wants to Debate

Bob thinks we can debate all this in an hour 🙂
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3/4/2013 – 7:58pm – You posted on Colorado Public Television (CPT12):

“ANP is toxic as anything!”

So you’re saying what ?

ANP is as toxic as water ?

[1]
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“It gives people insanely high sodium, and Burzynski is currently not allowed to be dispensed by Burzynski because, according to a patient, it killed someone”

FAIL – provides no citation(s), reference(s), or link(s) to support “toxic” and “tons of chemo” statements

[1]
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“This is not harmless stuff”

“This is not non-toxic”

FAIL – provides no citation(s), reference(s), or link(s) to support “toxic” and “tons of chemo” statements

[1]
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“And most of Burzynski’s patients never qualify for his trials”

“That’s the lure”

“They all end up taking tons of chemo used off label”

FAIL – provides no citation(s), reference(s), or link(s) to support “toxic” and “tons of chemo” statements

“Tons of chemo” ?

Even your “man-crush” cancer oncologist has blogged that it’s “low-dose” chemo

======================================
12/13/2012 – Stanislaw Burzynski: “Personalized gene-targeted cancer therapy” for dummies
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http://scienceblogs.com/insolence/2012/12/13/stanislaw-burzynski-personalized-gene-targeted-cancer-therapy-for-dummies/
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[1]
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3/5/2013 at 12:25pm – You posted on CPT12:

“How awful does your feedback need to be before you realize that you are going to endanger your viewership?”

The feedback was:

241 – Yes
97 – No
2 – Undecided

What was your point ?

[2]
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3/12/2013 – Why did “The Skeptics™” on CPT12 resort to adolescent name-calling:

“trolls,” “spammers,” “disingenuous,” “dishonest,” “profoundly dishonest,” “sheer stubborn stupid,” “stupid,” “spambot,” “fools,” “shills, “conman” ?

Don’t they have the intelligence a “Professor of Writing” should have ?

[3]
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3/12/2013 – Why did “The Skeptics™” on CPT12 and elsewhere whine about publication when the Declaration of Helsinki

30. addresses publishing human clinical trial data

does NOT indicate WHEN the data should be published, leaving it open to interpretation as to if it should be done piecemeal, or when all trials re a specific drug or drugs are completed after Phase I, II, or III, for example ?

[3]
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Why did “The Skeptics™” on CPT12 and elsewhere rant about scientific peer-reviewed journals and their “Impact Factors” but did NOT know what to do about this ?:

National Cancer Institute
at the National Institutes of Health

Cancer Clinical Trials

15. “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

[4]
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Blaskiewicz, do you have this many honors / awards ?

20 – HONORS AND AWARDS

LIFETIME ACHIEVEMENT AWARD. March 2012. Dallas /Ft. Worth, TX

The Order of Merit of the President of Poland – Officer’s Cross, October, 2004

Decoration of Polish Medical Association, November, 2001

The Order of Saint Brigida – Grand Cross with Star, November, 2001

The Order of Saint Stanislas – Grand Cross with Star, November, 2000

The Order of Reconciliation – Noember, 2000

The Cross Virtus Nobilitat, June, 1999

The Wisdom Award of Honor, December, 1998

The Medal of the President of City of Lublin, Poland, December, 1998

The Order of Saint Stanislas- Commander’s Cross with Star, December, 1997

The Lady Liberty Award “for engaging in invigorating the Right to be Secure in their Effects by fourteen years of perseverance in practicing his Profession free of interference by a government having no probable cause and in the determined resistance to that interference,” Libertarian Party of Texas, Dallas, TX, July, 1997

The Gold Medal from the American Institute of Polish Culture for outstanding achievements in the field of medicine and discovery of anti-cancer drugs antineoplastons, Miami, FL, February, 1997

The Medal “Heart for Hearts” for saving human lives, Lublin, Poland, August, 1997

The Memorial Medal of Zamoyski’s Lyceum in appreciation of outstanding contribution to increase scientific ranking of the school, Lublin, Poland, November, 1997

The Heritage Award by Polish American Congress in recognition of extraordinary achievement in the research, treatment, and prevention of cancer, Chicago, IL, October, 1993

Special Medal from the Polish government’s Institute for Drug Research and Control for achievement in the field of cancer research, Bialvstok, Poland, September, 1989

Honorable Membership in the Academia del Medeterraneo, Rome, Italy, 1984

Recipient of commendation for Dedicated Service and for Personal Contribution made in the
Advancement of Medical Education, Research and Health Care, Baylor College of Medicine, Houston, TX, April, 1977

Recipient of Medical Doctor Diploma with Distinction, Medical Academy, Lublin, Poland, 1967

Co-winner of the prize for best paper presented at the 7th Conference of Polish Medical Student Research
Societies, Poanan, Poland, 1966

[5]
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Why do some Burzynski critics claim they are NOT a “group” when they comment on each others blogs?

“That’s why I like the idea of the campaign that Bob Baskiewicz has come up with to wish Dr. Burzynski a happy birthday this year, skeptic style:”

(Citing and linking to 1/4/2013 blog)

1/4/2013 – Bob Blaskiewicz @rjblaskiewicz
Happy Birthday, Dr. Burzynski!
http://thehoustoncancerquack.com/2013/01/04/happy-birthday-dr-burzynski

3/15/2013 – Bob Blaskiewicz @rjblaskiewicz

https://twitter.com/gorskon/status/312601559647281154
retweeted David Gorski @gorskon Orac @oracknows (David H. Gorski) #sciencebasedmedicine

1/7/2013
Post #2 – rjblaskiewicz @rjblaskiewicz (Bob Blaskiewicz) – Wisconsin – Thanks, PZ

Posted by PZ Myers 1/6/2013
Let’s make Houston cancer quack Burzynski pay!

1/7/2013
Post #2 – Robert Blaskiewicz @rjblaskiewicz (Bob Blaskiewicz) –
“The Skeptics” non-group activity on Forbes:

[6]
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https://twitter.com/rjblaskiewicz/status/310589187797700608
Except YOU have NOT yet actually demonstrated that you believe in “interesting and civil discussions

[7]
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https://twitter.com/rjblaskiewicz/status/310856694525730817
Bobby, please point out where the Declaration of Helsinki supports your tweet?
http://www.wma.net/en/30publications/10policies/b3
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Please point out where the National Cancer Institute (NCI) at the National Institutes of Health (NIH) supports your tweet
http://m.cancer.gov/topics/factsheets/clinical-trials
[7]
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https://twitter.com/rjblaskiewicz/status/310923414175105024

https://twitter.com/rjblaskiewicz/status/311317995861442560
Do you mean THIS present ?

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

PZ Myers

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

“his snake oil”

“bilk people out of buckets of money”

“Crime does pay”

“This fraud”

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

“The lies”

“his quackery”

======================================
Let’s make Houston cancer quack Burzynski pay!
Posted by PZ Myers on January 6, 2013
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http://scienceblogs.com/pharyngula/2013/01/06/lets-make-houston-cancer-quack-burzynski-pay/
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Do you mean THIS St. Jude ?
St. Jude:
http://www.stjude.org/stjude/v/index.jsp?vgnextoid=403c6f9523e70110VgnVCM1000001e0215acRCRD

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

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

Burzynski does NOT receive Federal Funds

[7]
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Tax-Exempt: Receives Federal Grants / Funds
http://www.stjude.org/stjude/v/index.jsp?vgnextoid=b7e79bb8a0cf5110VgnVCM1000001e0215acRCRD&cpsextcurrchannel=1
Burzynski does NOT receive Federal Grants

Burzynski is NOT Tax-Exempt

[7]
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Donations to St. Jude are tax deductible as allowed by law
http://www.stjude.org/stjude/v/index.jsp?vgnextoid=6f8afa3186e70110VgnVCM1000001e0215acRCRD&vgnextchannel=2f62940504f9a210VgnVCM1000001e0215acRCRD

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

[7]
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FORBES: St. Jude CEO – $742,718
http://www.forbes.com/fdc/welcome_mjx.shtml
[7]
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https://twitter.com/rjblaskiewicz/status/310964881253867521
THIS Phenylbutyrate (PB) ?

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

SODIUM PHENYLBUTYRATE was given an orphan drug designation by the FDA for use as an adjunct to surgery,
radiation therapy, and
chemotherapy
for treatment of individuals with
primary or recurrent malignant glioma

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

Pubmed 110 entries
Sodium Phenylbutyrate
“Sodium Phenylbutrate (aka PB) …”
Sodium Phenylbutyrate (PB)

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

Bob, you do know that the research only took off once Dvorit D. Samid (Burzynski I) learned about it from Burzynski, right ?

[7]
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https://twitter.com/rjblaskiewicz/status/310979838372626432
THESE trials ?

2003 – 2006 Phase II preliminary reports

2003 – Phase II
Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma:

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

recurrent diffuse intrinsic brain stem glioma

antineoplaston A10 and AS2-1

6 months median duration of treatment
of all 12 patients

2 years / 33.3% – Survival

2 / 17% – alive and tumour free for over 5 years since initial diagnosis
from the start of treatment

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

Only mild and moderate toxicities were observed, which included
3 cases of skin allergy
2 cases of:
anaemia
fever
hypernatraemuia
single cases of:
agranulocytosis
hypoglycaemia
numbness
tiredness
myalgia
vomiting

2003 – Protocol – recurrent diffuse intrinsic brain stem glioma

12 – Patients Accrued
10 – Evaluable Patients

2 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
3 / 30% – # and % of Patients Showing Stable Disease
2 / 20% – # and % of Patients Showing Progressive Disease

2004 – Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma :

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

incurable recurrent and progressive multicentric glioma

antineoplaston A10 and AS2-1 (ANP)

9 – patients’ median age

6 patients were diagnosed with pilocytic astrocytoma
4 with low-grade astrocytoma
1 with astrocytoma grade 2
1 case of visual pathway glioma, a biopsy was not performed due to a dangerous location

16 months – The average duration of intravenous ANP therapy
19 months – The average duration of oral ANP

1 patient was non-evaluable due to only 4 weeks of ANP and lack of follow-up scans
1 patient who had stable disease discontinued ANP against medical advice and died 4.5 years later

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

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

2004 – Protocol – incurable recurrent and progressive multicentric glioma

12 – Patients Accrued

33% – % of Patients Showing Complete Response
25% – % of Patients Showing Partial Response
33% – % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease

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

13 children with recurrent disease or high risk

6 (46%) survived more than 5 years

2005 – Protocol – recurrent disease or high risk

23% – % of Patients Showing Complete Response
8% – % of Patients Showing Partial Response
31% – % of Patients Showing Stable Disease
38% – % of Patients Showing Progressive Disease

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

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

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

Treatment is even more challenging when an inoperable tumor is of high-grade pathology (HBSG)
patients with inoperable tumor of high-grade pathology (HBSG) treated with antineoplastons in 4 phase 2 trials

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

17+ years maximum survival for a patient with anaplastic astrocytoma

5+ years for a patient with glioblastoma

39% – Progression-free survival at 6 months

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

18 – evaluable
4 – glioblastomas
14 – anaplastic HBSG
14 – diffuse intrinsic tumors
12 – recurrence
6 – did not have radiation therapy or chemotherapy

Antineoplastons, A10 (A10I) and AS2-1 injections
5 months median duration
Responses were assessed by gadolinium-enhanced magnetic resonance imaging and positron emission tomography
Antineoplastons tolerated very well
1 case of grade 4 toxicity (reversible anemia)

2006 – Protocol – high-grade pathology (HBSG)

18 – Evaluable Patients

11% – % of Patients Showing Complete Response
11% – % of Patients Showing Partial Response
39% – % of Patients Showing Stable Disease
39% – % of Patients Showing Progressive Disease

Or did you expect Burzynski to publish the final clinical trial results before they were finished, Bob?

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

https://twitter.com/rjblaskiewicz/status/311091486349475840
Bobby, oh REALLY ?

“The Skeptics” (Burzynski: Cancer is Serious Business, Part II)

The “group” “The Sketics” claims is NOT a “group” and which allegedly does NOT spread “misinformation”
https://stanislawrajmundburzynski.wordpress.com/2013/03/24/the-skeptics

[7]
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https://twitter.com/rjblaskiewicz/status/311524673819144192
No Bobby, you did NOT

[7]
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https://twitter.com/rjblaskiewicz/status/311543395556409344
“VAMPIRE” ?

[7]
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https://twitter.com/rjblaskiewicz/status/311594720373645312
Bobby, like THIS ?

Stanislaw Rajmund Burzynski, M.D., Ph.D and “Freedom of Speech”

“The most stringent protection of free speech would not protect a man in falsely shouting ‘fire’ in a theater and causing a panic.”

United States Supreme Court ruled 3/3/1919

Schenck v. United States, 249 U.S. 47 (1919)
https://stanislawrajmundburzynski.wordpress.com/2013/03/24/stanislaw-rajmund-burzynski-m-d-ph-d-and-freedom-of-speech

[7]
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https://twitter.com/rjblaskiewicz/status/311681213934997505
Bobby, like THIS ?
David H. Gorski and the Cult of “MISINFORMATION”
Colorado Public Television 12 – PBS: Part II
https://stanislawrajmundburzynski.wordpress.com/2013/03/10/david-h-gorski-and-the-cult-of-misinformation
Orac and the Cult of “Misinformation” (Part III)
David H. Gorski
https://stanislawrajmundburzynski.wordpress.com/2013/03/11/orac-and-the-cult-of-misinformation-part-iii
Josephine Jones and the Cult of Misinformation
JJ recently blogged:
https://stanislawrajmundburzynski.wordpress.com/2013/03/13/josephine-jones-and-the-cult-of-misinformation
Keir Liddle and the Cult of MISINFORMATION
https://stanislawrajmundburzynski.wordpress.com/2013/03/09/keir-liddle-and-the-cult-of-misinformation
The Cult of “Misinformation”
Review of “disinformation,” “misinformation,” and “misdirection” posted by #Burzynski critics
https://stanislawrajmundburzynski.wordpress.com/2013/03/11/the-cult-of-misinformation
The cult of “Misinformation” continued
Adam Jacobs
https://stanislawrajmundburzynski.wordpress.com/2013/03/12/the-cult-of-misinformation-continued

[7]
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https://twitter.com/rjblaskiewicz/status/311854061550960642
Bobby, where’s your
Citation(s),
Reference(s), and / or
Link(s) ?

[7]
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https://twitter.com/rjblaskiewicz/status/311859126965788672
Bobby, Adam Jacobs does NOT care about “FREE SPEECH,” he censors it:
http://dianthus.co.uk/burzynski-qa

[7]
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https://twitter.com/rjblaskiewicz/status/311931318629986305
Well, Bobby, We know a lot of the skeptics seem to “hate” the truth

[7]
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https://twitter.com/rjblaskiewicz/status/312013682408292354
Bobby, maybe you should have actually watched THIS:

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

[7]
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https://twitter.com/rjblaskiewicz/status/312052091407433728
Bobby, maybe you should ACTUALLY listen to it

[7]
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https://twitter.com/rjblaskiewicz/status/31212153099585536

Yeah, riiiiiiiiight, Bobby
rjblaskiewicz:

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

Learning is Cool

Response to the release of Burzynski 2, Havanna Nights

Posted by Bob

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

The text of my segment follows the episode

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

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

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

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

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

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

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

(those notes did NOT seem very “key” considering Orac’s (David H. Gorski @gorskon #sciencebasedmedicine @ScienceBasedMed @oracknows)

“Second-Hand” “review” of Burzynski: Cancer is Serious Business, Part II)

“skeptics are hiding behind their BS free speech.”

(Yep, TRUE)

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

We are wiggly little scumbags who are hateful and slimy

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

[7]
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We ridicule the desperate and dying

Some of us are paid by big pharma

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

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

[7]
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But make no mistake–and this was hammered home to me by everyone I talked to–we are to them pure evil

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

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

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

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

Maybe they figured out your “opinion” and didn’t need any “clarification”

[7]
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Fine

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

I fully expect it to happen in the future

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

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

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

No real identifying information

Which, you know, I’m OK with

However, there are some problems here

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

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

Filmmakers ?

[7]
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2) Someone asked me about a quote,

“we’re coming for you, you little polish sausage you.”

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

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

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

That might be funny to you but maybe not to your Human Resources Department, and if that was “scary voices” and “scary music” to you, what’s the last scary movie you saw?

Scooby Doo, Where are You?

[7]
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It’s clear that the reason I’m in the movie in the capacity I am, as chief bad guy, is because I’m on video talking about the Burzynski Clinic

Are you sure it’s not because you are somewhere behind Gorski with the disinformation?

After all, he was invited to appear in the movie

Were you ?

[7]
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And this leads me to another thing that Brian mentioned

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

“skeptical teleconference”

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

“How did you get this footage of these scheming skeptics?”

Um….we publicize our show constantly?

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

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

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

Could you do that more?”

Really, Eric?

(Do you know it was Eric ?

After all, you thought I was Eric)
Bob Blaskiewicz

[7]
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Yeah, I have a feeling it’s Merola

That’s just me though

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

Do you think I’m two years old?
(Your “fact-checking” ability makes me wonder)

[7]
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I am interested in ultimately seeing it

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

(As if jref is a “reliable source”)

[7]
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Or you could screen it in Minneapolis

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

I guess he wasn’t

[7]
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Another thing

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

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

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

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

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

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

[7]
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Skeptics evilly, and with malice aforethought, raised $14.5K dollars for St. Jude’s

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

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

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

[7]
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This demonization is unfair and at the expense of the truth–if you ever read theotherburzynskipatientgroup blog you know whose side I’m on

P Z who ?

[7]
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If he used the video clip of us that he cited in his letter to my employer, about us bringing a “present” to Burzynski and knowing what it actually was without clarifying it, well, that just speaks to his regard for completeness and accuracy

I don’t think you really wanted P Z’s “present” “clarified”

[7]
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No messiah should need such fudging

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

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

[7]
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References:

PZ Myer’s announcement of the Houston Cancer Quack
http://scienceblogs.com/pharyngula/2013/01/06/lets-make-houston-cancer-quack-burzynski-pay/
The Virtual Skeptics episode that appears in the movie:
http://www.youtube.com/watch?v=IK-yF8w6nLo

RJB
rjblaskiewicz:
http://t.co/F79zndTjuZ

https://twitter.com/rjblaskiewicz/status/312234423288487936
Bob Blaskiewicz retweeted

https://twitter.com/jref/status/312255856928509953
Bobby, did you know that I tried to post a comment on the James Randi Educational Funding (jref) article Written by Brian Thompson, about this, but they did NOT post my response ?

Did you post something about “FREE SPEECH” ?

“Burzynski II” Fails to Convince
Swift”
http://www.randi.org/site/index.php/swift-blog/2050-qburzynski-iiq-is-more-of-the-same.html

[7]
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My 1st-hand Review of Orac’s 2nd-Hand Review – Burzynski: Cancer is Serious Business, Part II

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

https://twitter.com/rjblaskiewicz/status/312998393259622402
Bobby, does this mean it will be punctuated correctly, but NOT “Fact-Checked” ?

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/313465677614817280
Bobby, it did NOT help

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/313496736708583424
rjblaskiewicz:
Not really. 🙂

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/313508346399428608
That’s what I thought, Bobby

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/313725494170361856

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/313741293576667137

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/310589187797700608
Bobby, what was that about
“many interesting and civil discussions” ?

[7]
——————————————————————
Bobby, you can’t always get what you want

But if you try sometime, you just might find

you get what you need

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/314115938960154624
Bobby, let me guess

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

[7]
——————————————————————
You do know FDA required ?

” … in 1997, his medical practice was expanded to include traditional cancer treatment options such as
chemotherapy,
gene targeted therapy,
immunotherapy and
hormonal therapy
in response to FDA requirements that cancer patients utilize more traditional cancer treatment options in order to be eligible to participate in the Company’s
Antineoplaston CLINICAL TRIALS
http://www.sec.gov/Archives/edgar/data/724445/000091205702038660/a2091272z10qsb.txt

[7]
——————————————————————

https://twitter.com/rjblaskiewicz/status/315972148684529664
Yes it does, Bobby
You’ve just been Insolently pwned

[7]
——————————————————————
Skeptical Humanities
Learning is Cool

A Letter to the PBS Ombudsman about CPT12′s Airing of
“Burzynski”
http://t.co/RxDZHDN2RM
Posted by Bob

PBS Ombudsman Michael Getler

“To understand the complexities and history involved takes a lot of work, far more than we could possibly expect of Mr. Getler”

(or, as I have proven, of YOU)
https://stanislawrajmundburzynski.wordpress.com/2013/03/26/critiquing-bob-blaskiewicz-burzynski-cancer-is-serious-business-part-ii

[8]
——————————————————————
“That said, however, I do disagree with some of his conclusions”

(You could see that coming a mile away, couldn’t you?)

Getler starts off:

[ ” … It is about the decades-long struggle of a Polish-born physician and biochemist, Stanislaw Burzynski, who set up a clinic in Texas in 1976, to achieve acceptance for a cancer-cure therapy based on a treatment he developed based on what he calls “Antineoplastons.” [ANP]”

“I submit this is already wrong
There is little evidence that Burzynski is at all serious about developing antineoplastons for wider marketing”

THAT certainly explains the Phase III stuff

[8]
——————————————————————
“If that were true, surely he would have managed to have completed and published a single advanced trial in 35 years

Bob, who was ultimately in charge of the trials?

The FDA ?

[8]
——————————————————————
“If you look at the trials he’s been required to register at clinicaltrials.gov, you see over 60 trials, 1 completed, and none published

NONE”

Bobby, where is the
Citation(s),
Reference(s), and / or
Link(s)

that support your
“required to register”
statement ?

NONE ?

Are you a sociopath who thinks that people should believe you just because you blogged or twitted it ?

[8]
——————————————————————
“This is important because he is restricted to giving his ANP in clinical trials

But he apparently abandons his trials, almost all of them

This is not normal”

Bobby, how many is
“almost all of them” ?

[8]
——————————————————————
“He charges patients out the nose to participate in the clinical trials

This is not normal”

Does it cost as much as any of THESE ?

Cost cancer: The hospital wanted a $30,000 deposit
http://articles.cnn.com/2009-06-16/politics/health.care.hearing_1_health-insurance-post-claims-underwriting-individual-health?_s=PM:POLITICS
2008 – Cost cancer insurance: Avastin, made by Genentech, is a wonder drug. Approved for patients with advanced lung, colon or breast cancer, it cuts off tumors’ blood supply, an idea that has tantalized science for decades. And despite its price, which can reach $100,000 a year, Avastin has become one of the most popular cancer drugs in the world, with sales last year of about $3.5 billion, $2.3 billion of that in the United States. Avastin costs $50,000 a year and adds four months of life. “There is a shocking disparity between value and price,” he said, “and it’s not sustainable.”
http://www.nytimes.com/2008/07/06/health/06avastin.html?_r=0
Cost cancer chemo up-front: $45,000 to Come In
http://online.wsj.com/public/article/SB120934207044648511.html?mod=2_1566_topbox#articleTabs%3Darticle
3/2012 – Total Cost of Cancer Care by Site of Service: Physician Office vs Outpatient Hospital (22 pages)
http://www.avalerehealth.net/news/2012-04-03_COA/Cost_of_Care.pdf
CHEMOTHERAPY:
9/24/2012 – The newspapers found hospitals are routinely marking up prices on cancer drugs by two to 10 times over cost. Some markups are far higher. • Levine Cancer Institute, owned by Charlotte-based Carolinas HealthCare, this year collected nearly $4,500 for a 240-milligram dose of irinotecan, a drug used to treat people with colon or rectal cancer. The average sales price for that amount of the drug: less than $60.
• Carolinas Medical Center-NorthEast in Concord was paid about $19,000 for a one-gram dose of rituximab, used to treat lymphoma and leukemia. That was roughly three times the average sales price.
• Forsyth Medical Center in Winston-Salem, owned by Novant Health, collected about $680 for 50 milligrams of cisplatin. The markup: more than 50 times the average sales price. Treating a cancer patient with Avastin, for instance, costs about $90,000 a year, doctors say
http://www.charlotteobserver.com/2012/09/24/3549634/prices-soar-as-hospitals-dominate.html
5/14/2012 – Oral anti-cancer medications, on the other hand, are generally considered a pharmacy benefit. Instead of a co-payment, plan members often pay a percentage of the drugs’ cost — up to 50 percent, in some cases — with no annual out-of-pocket limit. And these drugs are expensive, often costing tens of thousands of dollars a year.
http://articles.washingtonpost.com/2012-05-14/national/35457286_1_lung-cancer-drug-drugs-work-multiple-myeloma-patients
RADIATION:
1/4/2013 – The new study was the most comprehensive cost analysis ever, and it compared the costs and outcomes associated with the various types of treatment for all forms of the disease, which ranged from $19,901 for robot-assisted prostatectomy to treat low-risk disease, to $50,276 for combined radiation therapy for high-risk disease.
http://www.ucsf.edu/news/2013/01/13370/how-prostate-cancer-therapies-compare-cost-and-effectiveness
3/15/2012 – Using Surveillance, Epidemiology and End Results (SEER)-Medicare data, the researchers looked at 26,163 women with localized breast cancer who had undergone surgery and radiation from 2001 to 2005. They found that Medicare billing for IMRT increased from 0.9% of patients diagnosed in 2001 to 11.2% of women whose breast cancer was diagnosed in 2005.
The average cost for radiation treatment during the first year was $7,179 for non-IMRT and $15,230 with IMRT. Moreover, billing for IMRT was more than five times higher in regions across the nation where the local Medicare coverage determinations were favorable to IMRT compared to regions where coverage was unfavorable. sorafenib (Nexavar) in kidney cancer as an example. “NICE evaluated sorafenib as it was indicated for kidney cancer and determined that it indeed had value, but not $80,000 per year’s worth. The agency said that it would reimburse one-third of the total cost, and if the drug company wants to market their product to 60 million British citizens, they will need to be price flexible,”
http://www.ascopost.com/issues/march-15-2012/rising-costs-in-radiation-oncology-linked-to-medicare-coverage.aspx

http://cancer.disease.com/Treatment/Radiation-Therapy

Bob, did you watch Burzynski 2 and hear the lady talk about how much it was costing someone she knew for “traditional treatment ?

[8]
——————————————————————
“This is not the behavior of someone who intends to market the product widely later and expects a return on an investment

It sure looks like someone taking the money while he can”

THAT sure explains THIS 7/5/2012 Marketing and Consulting Agreement contract:
http://www.sec.gov/Archives/edgar/data/724445/000110465912047927/a12-16018_1ex10d10.htm

[8]
——————————————————————
“I put the word “documentary” in quotes above because while the actual film does indeed document very well Burzynski’s seemingly endless battle to win acceptance and approval for his treatment against the FDA, National Cancer Institute, patent challenges and big pharmaceutical companies — and includes very powerful filmed interviews with cancer survivors who say his treatment (in Texas, where it was allowed) saved them — it doesn’t have the kind of critical other-side that one is used to in other documentaries

That last part is true
the movie is one-sided”

Bobby, you do know that Eric Merola offered oncologist and self-described researcher, David H. Gorski

(@gorskon @oracknows @ScienceBasedMed #sciencebasedmedicine http://www.scienceblogs.com/Insolence http://www.sciencebasedmedicine.org)

the opportunity to appear in
Burzynski: Cancer is Serious Business, Part II, and he REFUSED, right ?

[8]
——————————————————————
“Of course, why this is might be more apparent if Mr. Getler had realized that Merola’s cousin was a patient of Burzynski (she later died, of course) and that Merola raised funds for his cousin’s treatments on his website

Merola is not impartial

He has skin in the game

He has sunk an enormous amount into Burzynski”

Yeah, just like every other documentary film-maker or director of multiple movies re the same subject (Jaws, Terminator, Predator, Alien, etc.)

[8]
——————————————————————
“Mr. Getler mentions that Shari Bernson, the person responsible for the programming and who appeared in fundraising spots, described the movie as “controversial.”

To someone on the outside, it may appear to be controversial

To someone who understands the science and process of publication and who has found endless descriptions of how patients end up making really, really bad choices out of desperation at that clinic, however, there is no controversy”

The “controversy” is “The Skeptics” who do NOT know how to “Fact-Check,” and instead “Insert Foot in Mouth”

[8]
——————————————————————
“The fact remains that after 35+ years, the Clinic has never produced a single reproducible result that would constitute the barest minimum for serious consideration among experts

It just hasn’t”

That certainly explains the antineoplaston studies done in Poland, South Korea, Russia, Egypt, Japan, China, Taiwan (ROC), and the USA

That China published their most recent antineoplaston A10 study 10/1/2010
Journal of Radioanalytical and Nuclear Chemistry
October 2010, Volume 286, Issue 1, pp 135-140
#Burzynski References: 5. – 6.

[8]
——————————————————————
The Randomized Japan study is scheduled for publication THIS year

“Should that ever happen (I’m not holding my breath), then, hell, yes, we’ll be on board cheering the advance of science”

“But he has to play by the rules

And this is important too, playing by the rules that all real researchers abide to

Part of the FDA’s job is to ensure that Burzynski’s people are doing this

And on February 7th, they were doing just that; they were in the facility inspecting to make sure that Burzynski’s team was playing by the rules

In a FOIA release this week, the FDA revealed a number of things that had been found out and reported to the clinic by the time the movie aired

By law, the Clinic had 15 days to respond, so if they responded, it was before CPT12′s love-in

(The observational notes can be found here:”
http://skepticalhumanities.files.wordpress.com/2013/03/burzynskiform483feb2013.pdf)

“Two investigators observed:”

“The IRB [Institutional Review Board] used an expedited review procedure for research which did not appear in an FDA list of categories eligible for expedited review, and which had not previously been approved by the IRB”

“Specifically, your IRB routinely provided expedited approvals for new subjects to enroll under Single Patient Protocols.”

“[2 adults and 3 pediatric patients are mentioned]”

“The IRB approved the conduct of research, but did not determine that the risks to subjects were reasonable in relation to the anticipated benefits (if any) to subjects, and to the importance of the knowledge that might be expected to result”

“Specifically, your IRB gave Expedited Approval for several Single Patient Protocols (SPP) without all the information necessary to determine that the risk to subjects are minimized.”

“[4 examples follow]”

“The IRB did not determine at the time of initial review that a study was in compliance with 21 CFR Part 50 Subpart D, ‘Additional Safeguards for Children in Clinical Investigations.’”

“Specifically, an IRB that reviews and approves research involving children is required to make a finding that the study is in compliance with 21 CFR Part 50 Subpart D, ‘Additional Safeguards for Children in Clinical Investigations.’”

“Your IRB approved research involving children without documentation of the IRBs finding that the clinical investigation satisfied the criteria under Subpart D.””

“[3 examples follow and there is a note that this is a repeat observation that had been found in an Oct 2010 Inspection.]”

“The IRB did not follow its written procedure for conducting its initial review of research”

“Specifically, the IRB is required to follow its written procedures for conducting initial and continuing review”

“Your IRB did not follow your written procedures for conducting initial and continuing review because these subjects received IRB approval via an expedited review procedure not described in your Standard Operating Procedures”

“If your IRB would have followed your own SOP for initial and continuing review, the following subjects would have received review and approval from the full board rather than an expedited review.””

“[2 adults and 3 pediatric patients are listed.]”

“The IRB has no written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any unanticipated problems involving risks to human subjects or others”

“Specifically, your current SOP-2012 v2-draft doc does not describe the requirements on Investigators on how unanticipated problems are reported to the IRB, Institutional Official, and the FDA, such as time intervals and the mode of reporting, or otherwise address how the prompt reporting of such instances will be ensured.”

“The IRB has no written procedures [in the SOP-2012 v2-draft doc] for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any instance of serious or continuing noncompliance with theses [sic] regulations or the requirements or determinations of the IRB.”

“A list of IRB members has not been prepared and maintained, identifying members by name, earned degrees, representative capacity, and any employment or other relationship between each member and the institution.”

“You have to play by the rules”

So, NOT as bad as THIS 9 pager ?
http://www.pharmalive.com/fda-warns-stem-cell-company-over-violations

Bob, you know these are just allegations, right ?

Not the final report ?

[8]
——————————————————————
“I’m not sure that this round of investigation is over yet, as the audience at the premier of the sequel was apparently told that the FDA was still on site”

“Researchers should not be playing fast and loose with the rules that protect children (a protected subject population, like prisoners and students–yeah, I’m IRB certified)”

“There should be procedures in place to see that proper oversight and reporting of unexpected events is ensured”

“Hell, there was apparently no document even saying WHO was on the IRB!”

“This is not a report on a serious research institution”

“It’s more like the observations of the IRB of a clown school”

How many more businesses with more IRB issues than Burzynski did you find during you intense “Fact-Finding” mission ?

Bob, did you read Burzynski’s publications with their notes about the IRB ?

“Back to Mr Getler’s letter:”

“On the other hand, Bernson’s sidekick on the in-studio, pledge-drive promotion who was interviewing the clinic spokesman, made me gag when she said,
“I’m Rebecca Stevens and I’m proud to be a journalist who asks the hard questions.”

There were no hard questions”

[I believe the question that followed up this statement was, “What is peer-review?”–RJB]

“And where Bernson may have gone too far, depending on who you believe, was in her statement that:

“Antineoplaston therapy has had significant success rates with terminal brain cancer patients and especially in children.”

No, she went too far no matter who you believe, and his next paragraph demonstrates this:”

“The National Cancer Institute, reporting last month on Antineoplastons, said, among other things:

“No randomized, controlled trials showing the effectiveness of antineoplastons have been published in peer-reviewed scientific journals”
and that they are
“not approved by the U.S. Food and Drug Administration for the prevention or treatment of any disease.”

Aaaand…how’s that controversial?

In light of this, how could Sherri possibly be right?

My bottom line is that CPT12 obviously has a right to show this film

Nobody questions that

“What we wanted, and what was offered to the station, was the opportunity to have an independent oncologist in the studio at the time of the broadcast, you know, to stir up the kind of informed discussion the station says they want to have instead of settling for two True Believers talking to two CPT12 pitch people”

“When the station had that opportunity, they walked away from it”

“That’s indefensible”

Bob, like your man-crush oncologist who refuses to debate ?

[8]
——————————————————————
“Especially when you consider that the people we are worried about, patients and their families, may NOT be as discerning as your average viewer, as CPT President Willard Rowland suggests in his response to the ombudsman:

“The program’s airing is grounded in the station’s mission, specifically those portions about respecting our viewers as inquisitive and discerning citizens, addressing social issues and public concerns not otherwise adequately covered in the community, and cultivating an environment of discovery and learning.”

Some of them haven’t had good news since their diagnosis”

“Then they hear that some lone genius with the cure for cancer is operating in Houston and they are on the next flight down”

“I’ve seen it dozens of times, and I have hundreds more patients on deck to write about”

“These are vulnerable, vulnerable people who deserve the best information from their public broadcasters”

“I’m fairly disappointed by the tepid response, honestly”

“I have a hard time imagining that Mr. Getler, or Mr Willard Rowland for that matter, could possibly think that this program was anything but misleading if they spent a half hour at The OTHER Burzynski Patient Group, which chronicles, in patients’ own words, what goes on in that Clinic”

“All of the people told that getting worse is getting better”

“(for decades being fed the same line!),

the children having strokes

(unrelated to their tumors)

while on the medicine, the “terrifying” amounts of sodium that go into patients”

“The quasi-legalistic threats and phone calls to dissatisfied cancer patients”

“The untested chemo cocktails given to most of his patients”

“None of that was mentioned in the CPT12 fundraiser”

“Of course, that’s not Mr. Getler’s fight”

RJB
http://skepticalhumanities.com/2013/03/26/a-letter-to-the-pbs-ombudsman-about-cpt12s-airing-burzynski
Maybe you should go here and explain the critics actions:
https://www.facebook.com/questions/488444654552853

[8]
——————————————————————
HoustonCancerQuack proclaims:

“Fact-checking Burzynski II”

“DO YOU THINK YOU HAVE AN OPEN MIND?”

“DO YOU HAVE THE ALL THE FACTS?”

Let’s find out if they have all the “FACTS,” shall we?

“Basic claims about ANP”

“Antineoplastons are chemotherapy, regardless of what supporters say”

Bob, it is NOT “ordinary” chemotherapy”

[9]
——————————————————————
“Toxicity, reactions, and even patient deaths can and do happen due to their administration”

FACT: Is any citation, reference, or link to an independent reliable source provided for this claim?

“patient deaths can and do happen due to their administration”

NO

FACT: This is only an “opinion” until it is supported by “FACTS”

Here is what the National Cancer Institute (NCI) at the National Institutes of Health (NIH) lists as POSSIBLE “Adverse Effects”:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page6

[9]
——————————————————————
“The most common side effect of ANP, hypernatremia, is an effect of the sodium in the mixture”

FACT: Is any citation, reference, or link to an independent reliable source provided for this claim?

NO

FACT: Is “HYPERNATREMIA” listed on the above National Cancer Institute (NCI) at the National Institutes of Health (NIH) list as a possible “Adverse Effect”?

Let’s see what we can find out about “HYPERNATREMIA,” shall we?

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
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)
DOI
10.1007/s00520-013-1734-6
http://link.springer.com/article/10.1007%2Fs00520-013-1734-6
This 3 month study of 3,446 patients in 2006 found that most of the HYPERNATREMIA (90 %) was acquired during hospital stay

HYPERNATREMIA in the U.S.:
http://www.nlm.nih.gov/medlineplus/ency/article/000394.htm
HYPERNATREMIA is the most common electrolyte disorder in the United States

In some cases, cancer may cause the condition

[9]
——————————————————————
“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

“There are two cases of children (Haley S. and Elizabeth K.) at The OTHER Burzynski Patient Group who have had strokes unrelated to their tumors, likely because of the treatment”

FACT: Is any citation, reference, or link to an independent reliable source provided for this claim?

NO

FACT: Is “STROKE” listed on the above National Cancer Institute (NCI) at the National Institutes of Health (NIH) list as a possible “Adverse Effect”?

FACT: This is only an “opinion” until it is supported by “FACTS”

[9]
——————————————————————
“For an example of a patient nearly overdosing, see Adam M’s story”

“Patients seem to often end up in the hospital because of the treatment”

FACT: Is any citation, reference, or link to an independent reliable source provided for this claim?

NO

FACT: Is “ENDING UP IN THE HOSPITAL” listed on the above National Cancer Institute (NCI) at the National Institutes of Health (NIH) list as a possible “Adverse Effect”?

FACT: This is only an “opinion” until it is supported by “FACTS”

[9]
——————————————————————
“A surgical oncologist, researcher and patient advocate explains why physicians question Dr. Burzynski’s methods:”

My blog explains WHY I question this physician:
http://www.stanislawrajmundburzynski.wordpress.com

[9]
——————————————————————
“This physician and others declined to be interviewed for the movie because of Merola’s track record of slanted presentation and because of past threats issued by people hired by the Burzynski Clinic”

“Past threats issued by people hired by the Burzynski Clinic”?

FACT: Is any citation, reference, or link to an independent reliable source provided for this claim?

NO

FACT: This is only an “opinion” until it is supported by “FACTS”

excuses, Excuses, EXCUSES
https://stanislawrajmundburzynski.wordpress.com/2013/04/18/david-h-gorskis-conspiracy-mongering-and-more-of-his-dr-stanislaw-burzynski-stories

[9]
——————————————————————
“What was the “present” from skeptics that was alluded to in the movie?”

“The “present” the Skeptics for the Protection of Cancer Patients (SPCP) delivered to Burzynski on his birthday, was a donation of $14,500 to St Jude Children’s Hospital for research into childhood cancers”

“They challenged Dr. Burzynski to match their donation”

“He did not”

“In fact, some of the interviews in the movie (conducted after the FDA inspection of the Burzynski Clinic, mentioned at the end) were filmed after the fundraiser had been announced, so Merola seems to have deliberately omitted the whole truth, because he certainly was aware of it”

“Doesn’t sound so sinister now, does it?”

“Also, Burzynski got a card”

Want to know what that “PRESENT” really was?

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

[9]
——————————————————————
“Are skeptics really calling out cancer patients, ridiculing and harassing them?”

You tell me:

https://twitter.com/Ac2cSheila/status/186164592676843520

https://twitter.com/RatbagsDotCom/status/304050113834262528

[9]
——————————————————————
“What about the 2-hour rejection from The Lancet?”

“The vast majority of papers that get rejected from The Lancet are rejected within 48 hours thanks to an editorial pre-screening process”

“Most researchers are thankful for this courtesy because it allows them to resubmit to other journals more quickly”

“Why does Merola try to convince the audience that this is evidence of a conspiracy against Burzynski?”

Why bring it up if you really have nothing to add that is relevant?

FACT: The Lancet Oncology will not discuss any submission that may or may not have been submitted to The Lancet Oncology with anyone other than the corresponding author

To do so would constitute a breach in confidentiality

[9]
——————————————————————
“Patients pay a lot of money upfront to enter his clinical trials, presumably believing that the trials will eventually be published”

Is that really the patients’
motivation?

FACT: Is any citation, reference, or link to an independent reliable source provided for this claim?

NO

FACT: This is only an “opinion” until it is supported by “FACTS”

[9]
——————————————————————
“Burzynski has never published the results of those trials but keeps the money:”

Really?

Burzynski Clinical Trials (The SEC filings)
https://stanislawrajmundburzynski.wordpress.com/2013/04/11/burzynski-clinical-trials-2

[9]
——————————————————————
“Burzynski’s abysmal trial completion record, over sixty abandoned trials, the trust of every patient who participated betrayed”

“If trial completion were a batting average, he’d be batting .016”

Really?

FACTS:
http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11475951

http://cancer.gov/clinicaltrials/search/results?protocolsearchid=11476036

[9]
——————————————————————
“His publication average is .000”

“Really:”
http://clinicaltrials.gov/ct2/results?term=burzynski&pg=1
REALLY?
https://stanislawrajmundburzynski.wordpress.com/2013/04/18/david-h-gorskis-conspiracy-mongering-and-more-of-his-dr-stanislaw-burzynski-stories

[9]
——————————————————————
“Speaking of harassment…”

“Merola does not mention that skeptics only caught wind of the Burzynski story in November 2011, after a teenaged blogger critical of the Clinic received phony legal threats from someone who had been hired by the Clinic to “clean up” its reputation”

“This person, Marc Stephens, sent this high school student images of his family’s home, the message clearly:”

“We know where you live.”

“These threats were well documented in the international press”

“Somehow Merola managed to not mention that in the movie”

Maybe it wouldn’t be so bad if the loquacious “teenaged” high school student got his “FACTS” straight:

TheSkeptiCritic (@TheSkeptiCritic) tweeted at 8:12pm – 16 Apr 13:
https://twitter.com/TheSkeptiCritic/status/324329482712391680

http://rhysmorgan.co/blog

http://rhysmorgan.co/burzynski-morally-reprehensible

http://thewelshboyo.wordpress.com
[9]
——————————————————————
“What really happened to Amelia Saunders?”

“Merola suggests that Amelia Saunders died as a result of her parents taking her off of antineoplaston therapy, that there “confusion and disagreement” between the doctors in the UK and Houston’s reading”

Really?

https://twitter.com/frozenwarning/status/312141313451634688

https://twitter.com/BurzynskiMovie/status/312256370936266752

https://twitter.com/BurzynskiMovie/status/312264347277737984

https://twitter.com/BurzynskiMovie/status/312270472341487616
Burzynski Movie (@BurzynskiMovie) tweeted at 11:49pm – 14 Mar 13:
http://t.co/wxU2PHJ3GD

https://twitter.com/BurzynskiMovie/status/312425208462049280
[9]
——————————————————————
“We hope this makes it clear that what you are seeing in the new Burzynski movie may not be entirely reliable”

So … like your blog?

[9]
——————————————————————
“As we get more information about the claims in the movie, we will add additional rebuttals and provide context for understanding what really goes on at the Burzynski Clinic”
http://www.anp4all.com
I can’t wait
http://thehoustoncancerquack.com/fact-checking-burzynski-ii
[9]
======================================
Burzynski referenced by other doctors:

Phase II trial of tipifarnib and radiation in children with newly diagnosed diffuse intrinsic pontine gliomas
http://neuro-oncology.oxfordjournals.org/content/13/3/298.full
University of California—San Francisco
Children’s Hospital Boston, Massachusetts
St Jude Children’s Research Hospital, Memphis, Tennessee
Seattle Children’s Hospital, Seattle, Washington
Children’s Hospital of Philadelphia, Pennsylvania
Children’s Hospital of Pittsburgh, Pennsylvania
Children’s National Medical Center, Washington, DC
Cincinnati Children’s Hospital Medical Center, Ohio
Neuro Oncol (2011) 13 (3): 298-306
doi: 10.1093/neuonc/noq202
5.723 Impact Factor
25. ↵ Burzynski SR
Treatments for astrocytic tumors in children: current and emerging strategies
Paediatr Drugs. 2006;8:167-178
http://link.springer.com/article/10.2165%2F00148581-200608030-00003
Pediatric Drugs
May 2006, Volume 8, Issue 3, pp 167-178

[10]
——————————————————————
“[T]he emphasis in Phase 2 is on EFFECTIVENESS”

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

[11]
——————————————————————
9-10/2009 – Stable disease is a valid end point in clinical trials
http://www.ncbi.nlm.nih.gov/pubmed/19826356/
strong>10,675 – # of times “stable disease” found on PubMed
[12]
——————————————————————
costs (see above)

[13]
——————————————————————
rjblaskiewicz 1 week ago
(@rjblaskiewicz a/k/a Blatherskitewicz)

Mr. R.J. Blaskiewicz, is well known as:
“Bob Blaskiewicz, Faux Skeptic Exposed!”

There are numerous Internet pages and great pictures of him re Atlanta, Georgia, where he was called out, but hid behind his keyboard:

[14]
——————————————————————
Forbes – Waiting for the 10,000

Bob, I thought it funny that “The Skeptics” were allowed to comment freely on #Forbes, without citations, references, or links, while my comments were deleted

Did they ever have 10,000 views like Boris Ogon posted ?

[15]
——————————————————————
Forbes – rjblaskiewicz 6 days ago

“It’s not a thread about the inherent corruption throughout all of medicine.”

“It’s about some bully/man-child trying to shut up critics.”

Mr. rjblaskiewicz (also known as Bob Blaskiewicz), so, like Forbes was?

[16]
——————————————————————
c0nc0rdance – http://t.co/WDfUPtBpmz
56.�skeptical humanities
http://t.co/aMJ1HaUTfh
57.�skeptical humanities
http://t.co/EGhiG5WgQA
58.�skeptical humanities
http://t.co/Fwkd7x2E0C

Bob, how many times did y’all need to “mirror” the video ?

[17]
——————————————————————
David James (@stortskeptic) chat room
(@SkepticCanary)(@_JosephineJones)

Skeptic Canary – blogtalkradio

Man-crush

Freedom from Facts

Informed consent

Phenylbutyrate (PB)

Hypernatraemia

Skeptics are opposed to facts

Bob, you and Gorski did a great job of NOT cover these issues

BB claims his rbutr has been used to “Fair and utterly destroyed it,” in relation to “Burzynski: Cancer Is Serious Business

BB states:

“His son I believe trained in Poland”
Blatherskitewicz, with your phenomenal attention to detail, aren’t you positive?

BB mentions two (2) possible honorary professorships in China for Dr. Burzynski

Call in comments

[18]
——————————————————————
Faux Skeptic
Bob Blaskiewicz (@rjblaskiewicz)
6/3/13, 3:49 PM
@FauxSkeptic @bbc5live I believe he said, “Put up or shut up, you little bitch.” Something like that.

[19]
——————————————————————
March 29, 1996

Then United States Food and Drug Administration Commissioner, David Kessler told the American people:

1. We will eliminate unnecessary paperwork … that used to delay or discourage … cancer research … by non-commercial clinical investigators

2. The … FDA’s initiatives … will allow …the agency … to rely on smaller trials … fewer patients … if there is evidence … of partial response in clinical trials
I don’t want to get into any particular … agent … except let me point out … that … the information needs to be part … of clinical trials
3. We will accept … less information … up front –

4. we’re going to require further study AFTER … approval … because the science … has matured

5. The important – point … is that information needs to be gathered … through scientific means … through clinical – trials … and I think – that’s … that’s very important uhh very … important point
You can’t … just … use an agent here – or there … you have to use it … as part of a clinical trial … so we can get information … on whether the drug works

6. The uhh agency has … many … trials … has has approved trials … for patients … with antineoplastons

7. We are committed to providing expanded access … availability … for American patients for any drug … there’s reason to believe … may work
—————————————————————
A. What is the FDA’s definition of “unnecessary paperwork”?

B. What is the FDA’s definition of “smaller trials”?

C. What is the FDA’s definition of “fewer patients”?

D. What is the FDA’s definition of “evidence … of psrtial response”?

E. What is the FDA’s definition of “less information … up front”?

F. What is the FDA’s definition of “we’re going to require further study AFTER … approval”?

G. What is the FDA’s definition of “We are committed to providing expanded access … availability … for American patients for any drug … there’s reason to believe … may work”?

[20]
——————————————————————
?
Oncologist

Survival rate 776 15%

2 1/2 million pages

Phase 3 radiation

Lancet

1652 / 335 = 1,799

Accelerated approval

Bob, at least we talked about some of these

[21]
——————————————————————
IRB – FDA

Burzynski’s publications sometimes mentioned IRB was agreed on per FDA

[22]
——————————————————————
Bob Blaskiewicz (@rjblaskiewicz) tweeted at 10:44am – 31 Jul 13:

@TomLemley1 @AceofSpadesHQ @mikespillane The FDA won’t approve his drug until he ever finishes and publishes a trial. clinicaltrials.gov/ct2/results?te…

https://twitter.com/rjblaskiewicz/status/362599624596393984

[23]
——————————————————————
Robert J. (Bob) Blaskiewicz, Professor
Bob Blaskiewicz Faux Skeptic Exposed!
@rjblatherskiewicz
Blatherskitewicz
University of Wisconsin
rbutr
r-but-r
Eau Claire, Wisconsin
——————————————————————
http://www.skepticalhumanities.com/
——————————————————————
http://virtualskeptics.com/
——————————————————————
http://rbutr.com/
——————————————————————
http://blog.rbutr.com/
——————————————————————
http://www.uwec.edu/Staff/blaskir/
——————————————————————
http://www.csicop.org/author/rblaskiewicz
——————————————————————
http://necss.org/speakers/bob-blaskiewicz/
——————————————————————
http://www.centerforinquiry.net/speakers/blaskiewicz_bob
——————————————————————
http://lanyrd.com/2013/tam/sckkdy/
======================================
http://thehoustoncancerquack.com/

[24]
——————————————————————
Critiquing https://theotherburzynskipatientgroup.wordpress.com

[25]
——————————————————————
25. 6/20/2013 Mark Burger published a review:
——————————————————————
http://www.yesweekly.com/triad/article-16162-burzynski-cancer-is-.html
——————————————————————
As could be expected, The Skeptics™
showed up
======================================
ANONYMOUS: “I’m afraid you’ve fallen for Dr Burzynski’s PR efforts here”
——————————————————————
LIE: The documentary film is by Eric Merola, NOT “Dr. Burzynski’s Public Relations”
======================================
ANONYMOUS: “In reality, Dr B is a quack and a charlatan of the worst order, and the movie is nothing more than a desperate attempt to try to sell his snake oil to the gullible”
——————————————————————
LIE: After reading through the comments, this sounds like the infamous lying Professor Robert J. (Bob) Blaskiewicz of University of Wisconsin, Eau Claire, “infamy”, who is a charlatan of the first order, and belabors his ignorance by referring to “snake oil”, which as far as I know, has never been approved for phase III clinical trials, unlike Dr. Burzynski’s antineoplastons A10 (Atengenal) and AS2-1 (Astugenal)
——————————————————————
Bob Blaskiewicz (Blatherskitewicz), Faux Skeptic Exposed!:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/07/bob-blaskiewicz-blatherskitewicz-faux-skeptic-exposed/
======================================
ANONYMOUS: “You have to ask why he’s never published any data showing that his treatment works”
——————————————————————
LIE: What people should ask is why does “Professor” @rjblaskiewicz and his other Skeptic pals continue posting idiotic statements like this on the Internet and social media (Twitter) ?
——————————————————————
Critiquing David H. Gorski, MD, PhD, FACS
http://www.sciencebasedmedicine.org/editorial-staff/david-h-gorski-md-phd-managing-editor/
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/21/critiquing-david-h-gorski-md-phd-facs-www-sciencebasedmedicine-orgeditorial-staffdavid-h-gorski-md-phd-managing-editor/
======================================
ANONYMOUS: “Well, if you believe everything the movie tells you, then perhaps you think it’s because of a huge global conspiracy that prevents him from publishing in any journal anywhere in the world”
——————————————————————
If you want to talk Jesse Ventura type “conspiracy theory”:

1. Why are The Skeptics™ like you too afraid to debate ?

2. Why did your “pal” David H. “Orac” Gorski, MD, PhD, FACS block me on his blog for questioning his infallibility ?

3. Why did Forbes delete my comments when I questioned The Skeptics™? regarding your “pal” Gorski’s “bud”, Peter A. Lipson, MD’s article ?

4. Why did The Skeptics™ Josephine Jones block me from her blog ?

5. Why did The Skeptics™ Adam Jacobs block me from his blog ?

6. Why did The Skeptics™ Guy Chapman block me from his blog ?

7. Why did The Skeptics™ Keir Liddle block me from his blog ?

8. Why do The Skeptics™ whine to Twitter in order to get Twitter to suspend the accounts of people who question them ?

9. Why did Wikipedia block me, using lame excuses ?

10. Why did reddit act like wiki’s little bitch and delete my posts and block my comments because this reddiot davidreiss666 whined like a little bitch ?
——————————————————————
overview for DidymusJudasThomas (reddit.com)

submitted 4 days ago by davidreiss666 to reportthespammers

1 comment
======================================
ANONYMOUS: “Even if you are sufficiently conspiracy minded to believe that’s true, then it still doesn’t explain why he hasn’t published his results on the clinicaltrials dot gov website, where most of his trials are recorded as either “ongoing”, “withdrawn”, or “unknown status””
——————————————————————
Did you NOT appear on the below blog talk radio show with your “pal” Gorski who said at 29:00 that Burzynski should NOT publish the information himself ?
——————————————————————
Ep09 – Talking Burzynski – David Gorski and Bob Blaskiewicz 05/29/2013
Skeptic Canary Show – BlogTalkRadio
May 29, 2013 … This week, join your hosts as we talk about Dr. Stanislaw Burzynski and the Burzynski Clinic. Well be joined by two special guest, Doctor David Gorski and Bob Blaskiewicz
http://www.blogtalkradio.com/…/ep09–talking-burzynski–david-gorski-and-bob-blaskiewicz
——————————————————————
http://www.blogtalkradio.com/skepticcanary/2013/05/29/ep09–talking-burzynski–david-gorski-and-bob-blaskiewicz
——————————————————————
http://goo.gl/7pWIj
——————————————————————
http://bit.ly/15lv5zG
——————————————————————
Critiquing the #SkepticCanary: “The Skeptics™” (SkeptiCowards©) Bob Blatherskitewicz and the so-called, “self-proclaimed” “CANCER RESEARCHER”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/03/critiquing-the-skepticcanary-the-skeptics-skepticowards-bob-blatherskitewicz-and-the-so-called-self-proclaimed-cancer-researcher/
======================================
ANONYMOUS: “Only one of his trials is recorded as being completed, and that one doesn’t reveal it’s results”
——————————————————————
Did you notice that your above 5/29/2013 appearance was BEFORE this article was published 6/20/2013 ?
======================================
ANONYMOUS: “The fact is that Burzynski keeps is actual research data an extremely closely guarded secret”
——————————————————————
Like THIS ?
——————————————————————
Critiquing: Dr. David H. “Orac” Gorski, M.D., Ph.D, L.I.A.R.:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/07/critiquing-dr-david-h-orac-gorski-m-d-ph-d-l-i-a-r/
======================================
ANONYMOUS: “If is treatment were actually effective, do you seriously think he’d do that?”
——————————————————————
RATS!!!. Like this ?
——————————————————————
Burzynski: Oh, RATS!!!
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/26/the-lancet-oncology-peer-review-team-d-12-01519-fail-2/
======================================
ANONYMOUS: “Burzynski likes to cultivate his conspiracy theories because it helps his business of scamming vulnerable cancer patients”
——————————————————————
Is that like The Skeptics™ like to LIE to people ?
——————————————————————
Critiquing: In which the latest movie about Stanislaw Burzynski “cancer cure” is reviewed…with Insolence:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/18/critiquing-in-which-the-latest-movie-about-stanislaw-burzynski-cancer-cure-is-reviewed-with-insolence-2/
======================================
ANONYMOUS: “For Burzynski, at least, cancer is indeed serious business”
——————————————————————
And for you, it must be a joke, considering how you are too much of a coward to debate questions like these
——————————————————————
QUESTIONS the Critics and Cynics, “The Skeptics™” do NOT want to ANSWER:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/23/questions-the-critics-and-cynics-the-skeptics-do-not-want-to-answer/
======================================
JEFF: “it has been tested independently in other countries, as the film shows”
======================================
ANONYMOUS: “The Japanese study remains unpublished, Jeff, just like all the over 60 studies Burzynski has started”

“Even if it were published, it would need to be replicated”
——————————————————————
Really ? Why not try pointing out where these studies were replicated before the FDA allowed these drugs to be used ?
——————————————————————
Burzynski: Why has the FDA NOT granted Accelerated Approval for Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal) ?
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/28/burzynski-why-has-the-fda-not-granted-accelerated-approval-for-antineoplastons-a10-astengenal-and-as2-1-astugenal/
======================================
ANONYMOUS: “Merola manipulated by voice, face and even what I said in his movie and never asked for my comments”

“Sure, he misrepresented me to my new employers, but that doesn’t actually count as consulting me, now does it?”

“The “birthday surprise” in the movie was a fundraiser for a children’s cancer research hospital that raised over $15K, something I’m rather proud of, actually”
——————————————————————
Nice TRY with your LIE
——————————————————————
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/
======================================
ANONYMOUS: “I’d encourage you to look at the other side of the story at The OTHER Burzynski Patient Group”

“These are far more typical outcomes”
——————————————————————
Do you mean this one of a number of your blogs which I just critiqued ?
——————————————————————
Critiquing https://theotherburzynskipatientgroup.wordpress.com
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/24/critiquing-httpstheotherburzynskipatientgroup-wordpress-com/
======================================
ANONYMOUS: “You might also see what Merola got wrong/faked at the anp4all website”
——————————————————————
Oh, do NOT worry

I will critique this one also, and let people see what YOU got wrong
======================================
The Burzynski Skeptics:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/18/the-burzynski-skeptics/
======================================
CHEEZ WHIZ !!! http://anp4all.com is nothing more than Robert J. “Bob” Blaskiewicz (@rjblaskiewicz)’s thick processed cheese spread of http://thehoustoncancerquack.com
======================================
Where he asks:

DO YOU THINK YOU HAVE AN OPEN MIND? DO YOU HAVE THE ALL THE FACTS?
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/18/fact-checking-httpthehoustoncancerquack-com/
======================================
He is supposedly a “Professor of Writing”, but check out his writing gaffes here, as “ANONYMOUS”
======================================
Yes! Weekly: Burzynski: Cancer is Serious Business Part II:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/26/yes-weekly-burzynski-cancer-is-serious-business-part-ii/
======================================
Critiquing https://theotherburzynskipatientgroup.wordpress.com
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/24/critiquing-httpstheotherburzynskipatientgroup-wordpress-com/
======================================
“The skeptic who called Dr. Burzynski “my little Polish sausage” has a Polish last name, which the director Eric Merola scrubbed from the movie”

Just because you think that referring to someone as:

“my little Polish sausage”

is humorous, and therefor we should excuse your behavior because of your below excuse, does NOT mean that it makes it acceptable

“Literally one second after he said that, all of the other participants made jokes about that fact”

(which of course was the point)

“Instead allowing the audience to hear that ribbing, Merola inserted an evil laugh, which was lifted and spliced from minute 18:25 of Virtual Skeptics episode 13”

If you thought that was an “evil laugh”, you’ve got an overactive imagination

“Voices were altered to sound sinister, and menacing music was added”

If you thought voices sounded “sinister” and that was “menacing music”, you must not watch any scary movies

Do you think this is a fair representation or were you misled?

YES

I think it’s a fair representation that you try to mislead people

“What about the 2-hour rejection from The Lancet?”

“High impact journals like The Lancet receive huge numbers of submissions, as their journal is the most prestigious”

“The vast majority of papers that get rejected by The Lancet are rejected within 48 hours thanks to an editorial pre-screening process that helps accommodate this huge work load”

“Most researchers are thankful for this courtesy because it allows them to resubmit to other journals more quickly”

“Why does Merola try to convince the audience that this is evidence of a conspiracy against Burzynski?”

All of your above comments prove what a waste of time you are, based on:
======================================
See #13
——————————————————————
Critiquing: In which the latest movie about Stanislaw Burzynski “cancer cure” is reviewed…with Insolence:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/18/critiquing-in-which-the-latest-movie-about-stanislaw-burzynski-cancer-cure-is-reviewed-with-insolence-2/
======================================
2 hours 8 minutes and 51 seconds
The Lancet Oncology Peer Review Team D-12-01519: #FAIL
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/25/the-lancet-oncology-peer-review-team-d-12-01519-fail/
======================================
“Does Eric Merola have any conflicts of interest that he is not disclosing?”

“Eric Merola does not reveal a possible conflict of interest, one that a journalist would feel obliged to share”

“He fails to disclose in the movie that his cousin was a patient of Dr. Burzynski and that he has raised money on his movie’s website for patients to see Burzynski”

Sounds like someone failed to read the Frequently Asked Questions (FAQ) section on the BurzynskiMovie web-site:
======================================
http://burzynskimovie.com/index.php?option=com_content&view=article&id=75&Itemid=55
======================================
“Burzynski has never published the results of those trials but keeps the money:”

“Burzynski’s abysmal trial completion record, over sixty abandoned trials, the trust of every patient who participated betrayed”

“If trial completion were a batting average, he’d be batting .016”

“His publication average is .000.”

“Really:”
——————————————————————
http://clinicaltrials.gov/ct2/results?term=burzynski&pg=1
——————————————————————
Really ?

“over sixty abandoned trials” ?

This just shows that you do NOT even know the subject-matter

Have you even bothered to read Burzynski’s publications ?
======================================
Burzynski updates Scientific Publications page:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/12/burzynski-updates-scientific-publications-page/
======================================
Because if you had, you would know that Burzynski has used the clinical trial design proposed by Fleming
======================================
16. 2003 Trial design – Fleming (Pg. 94)
——————————————————————
17. 2004 Trial design – Fleming (Pg. 317)
======================================
Protocol Design

2-stage phase II clinical trial design proposed by Fleming used

Initially, 20 adequately treated patients to be assessed

If less than one Objective Response (Complete Response (CR) or Partial Response (PR)) observed, it’d be concluded there was less than desired activity and study would be discontinued

If one or more Objective Responses observed, 20 more patients would be accrued to study

If 4 or more responses observed among 40 patients, evidence would be sufficient to conclude the treatment has desired activity
======================================
One-sample multiple testing procedure for phase II clinical trials
http://www.ncbi.nlm.nih.gov/pubmed/7082756/
Journal
Biometrics. 1982 Mar;38(1):143-51
http://www.ncbi.nlm.nih.gov/m/pubmed/7082756/

http://www.jstor.org/discover/10.2307/2530297?uid=3739256&uid=2460338175&uid=2460337855&uid=2&uid=4&uid=83&uid=63&sid=21102589296903
======================================
“This person, Marc Stephens, sent this high school student images of his family’s home, the message clearly:”

“We know where you live.”

“These threats were well documented in the international press”

“Somehow Merola managed to not mention that in the movie”

Yes

Marc Stephens’ actions were idiotic

My personal opinion is that he should have done what I am doing, which is showing how “The Skeptics™ lie, misinform, disinform, misdirect, deceive, misrepresent, etc.

Eric Merola did NOT mention your lame blogs either

Why don’t you complain about that ?

“Burzynski has a long history of patients believing that symptoms of getting worse are signs they are getting better”

“Follow any of the links at that site to hear how, in patients’ own words, this EXACT SAME misleading interpretation has been fed to patients for decades”

So, are you a doctor ?

No ?

I didn’t think so, quack

“Merola has publicly slandered Burzynski critics in a way a real journalist couldn’t”

Why can “real journalists” NOT slander someone ?

“We hope this makes it clear that what you are seeing in the new Burzynski movie may not be entirely reliable”

So, like this web-site
======================================
DEBATE E-Mails:
======================================
On Mon, Sep 23, 2013 at 8:04 PM, Didymos Thomas wrote:
So now you’re brave ?

Bob Blaskiewicz @rjblaskiewicz

@PDJudasT @robertquickert Hey, Judas. I have no respect for you as a person. Never address me.
1:56 PM – 18 Mar 2013
https://twitter.com/rjblaskiewicz/status/313725494170361856
——————————————————————
On Monday, September 23, 2013, Robert Blaskiewicz wrote:
You going to be a rotten little troll or do you want to debate?
——————————————————————
You’re the one who posted this on Twitter

Do NOT try to make me the COWARD

Bob Blaskiewicz @rjblaskiewicz

@PDJudasT @robertquickert Hey, Judas. I have no respect for you as a person. Never address me.
1:56 PM – 18 Mar 2013
——————————————————————
2/13/2013 (7/2013)
The frequency, cost, and clinical outcomes of HYPERNATREMIA in patients hospitalized to a comprehensive CANCER center

Over 3 month period in 2006 re 3,446 patients, most of the HYPERNATREMIA (90 %) was acquired during hospital stay
http://www.ncbi.nlm.nih.gov/pubmed/23404230
——————————————————————
6/3/2013 – “[I]f I had screwed up, I would have admitted it”
http://www.sciencebasedmedicine.org/stanislaw-burzynski-propaganda-versus-news
“Our only goal is to promote high standards of science in medicine”
http://www.sciencebasedmedicine.org/editorial-staff/
11/.2/2012 – “Personally, having pored over Burzynski’s publications … “
http://scienceblogs.com/insolence/2012/11/02/stanislaw-burzynski-fails-to-save-another-patient/
5/8/2013 – “I’ve searched Burzynski’s publications … “
http://scienceblogs.com/insolence/2013/05/08/eric-merola-and-stanislaw-burzynskis-secret-weapon-against-the-skeptics-fabio-lanzoni-part-2/
5/31/2013 – “Burzynski has a contingent of defenders who have targeted skeptics like me for special abuse, up to and including harassing me at work by calling my university to complain about my online verbiage critical of Burzynski and implying that I am somehow doing something wrong”
“(My university quickly realized that I was not.)”
http://scienceblogs.com/insolence/2013/05/31/on-helping-that-is-anything-but/
6/5/2013 – “ … I do know cancer science”
http://scienceblogs.com/insolence/2013/06/05/odds-and-ends-about-burzynski-clinic/
6/7/2013 – “Unlike Mr. Merola, I am indeed very concerned with getting my facts correct”
http://scienceblogs.com/insolence/2013/06/07/i-want-my-anp/
.3/14/2013 – “Temodar and Avastin both had proper, completed, and published phase II trials before approval”
http://www.sciencebasedmedicine.org/burzynski-cancer-is-a-serious-business-part-2-like-the-first-burzynski-movie-only-more-so/
and
http://scienceblogs.com/insolence/2013/03/14/five-things-i-learned-second-hand-from-the-recent-screening-of-burzynski-cancer-is-serious-business-part-2/
I prove him wrong
https://stanislawrajmundburzynski.wordpress.com/2013/08/27/wayne-state-university-detroit-michigan-quickly-realized-that-david-h-gorski-md-phd-facs-is-not-doing-something-wrong-when-he-lies-about-burzynski/
——————————————————————
6/4/2013 – “Dr. Elloise Garside, a research scientists, echoes a lot of the questions I have, such as”

“how Burzynski never explains which genes are targeted by antineoplastons … “
http://scienceblogs.com/insolence/2013/06/04/stanislaw-burzynski-versus-the-bbc/
I prove him wrong
https://stanislawrajmundburzynski.wordpress.com/2013/08/07/critiquing-dr-david-h-orac-gorski-m-d-ph-d-l-i-a-r/
and
https://stanislawrajmundburzynski.wordpress.com/2013/09/21/critiquing-the-institute-of-medicine-report-on-cancer-care-is-the-system-in-crisis/
——————————————————————
Bob, this is unsupported, just like when Gorski put it on his blog:
Bob Blaskiewicz (@rjblaskiewicz) tweeted at 10:44am – 31 Jul 13:

@TomLemley1 @AceofSpadesHQ @mikespillaneThe FDA won’t approve his drug until he ever finishes and publishes a trial.clinicaltrials.gov/ct2/results?te…

https://twitter.com/rjblaskiewicz/status/362599624596393984
Bob, “unable to publish”? Shouldn’t that be “able to publish” but The Lancet Oncology would NOT publish?
——————————————————————
Manuscript reference number: THELANCETONCOLOGY-D-12-01519

Title: Glioblastoma multiforme: a report of long-term progression-free survival and overall survival of 8 to 16 years after antineoplaston therapy and review of literature

Dear Dr. Burzynski,

Thank you for your recent submission to The Lancet Oncology. We have now had time to consider your manuscript and unfortunately, on this occasion, we have decided not to publish it because we believe the message would be better elsewhere.

Although the decision has not been a positive one, I thank you for your interest in the journal and hope it does not deter from considering us again in the future

Josephine Jones (@_JosephineJones) tweeted at.5:21pm – 11.Sep.13:

@Majikthyse @frozenwarning @drpaulmorgan @dianthusmed @oracknows It was about 1hr30 mins into Burzynski Movie II. pic.twitter.com/8n3fQkX0v0

http://pbs.twimg.com/media/BT6kM-zCcAAHsnV.png

https://twitter.com/_JosephineJones/status/377919961659764736
Eric Merola revealed in Burzynski: Cancer Is Serious Business, Part II (2), at (1:29:53), that The Lancet Oncology Peer Review Team D-12-01519, in 2 hours 8 minutes and 51 seconds, refused to publish Burzynski’s 11/26/2012 phase 2 clinical trial Progression-Free Survival (PFS) and Overall Survival (OS) re patients 8 – 16 years after diagnosis, results
——————————————————————
Temozolomide received accelerated approval by the U.S. Food and Drug Administration 1/1999 for treatment of ANAPLASTIC ASTROCYTOMA (brain cancer) patients

At time of approval, NO RESULTS were available from randomized controlled trials in refractory ANAPLASTIC ASTROCYTOMA that show clinical benefit such as improvement in disease-related symptoms or prolonged survival
http://clincancerres.aacrjournals.org/content/11/19/6767.full
Was the United States Food and Drug Administration’s 1/1999 accelerated approval based on the PUBLISHED FINAL RESULTS OF A PHASE II (2) CLINICAL TRIAL?

12/2000 – Temozolomide and ANAPLASTIC ASTROCYTOMA:

NO CLEAR PROOF OF EFFICACY
http://www.ncbi.nlm.nih.gov/pubmed/11475493/
NO BETTER THAN SURVIVAL BEFORE THE INTRODUCTION OF temozolomide

The answer is: NO

1/1999 – FDA Accelerated Approval

9/1999 – Phase 2 publication

9/1999 – Multicenter phase II trial of temozolomide in patients with ANAPLASTIC ASTROCYTOMA or anaplastic oligoastrocytoma at first relapse

Temodal Brain Tumor Group
http://www.ncbi.nlm.nih.gov/pubmed/10561351/
M.D. Anderson Cancer Center
http://www.drugs.com/pro/temodar.html

http://www.temodar.com/temodar/index.do
2004 – Supratentorial high-grade ASTROCYTOMA and DIFFUSE BRAINSTEM GLIOMA:

two challenges for the pediatric oncologist
http://www.ncbi.nlm.nih.gov/pubmed/15047924/

http://m.theoncologist.alphamedpress.org/content/9/2/197.long
St. Jude Children’s Research Hospital

administration of temozolomide after RT DIDN’T ALTER POOR PROGNOSIS associated with newly diagnosed diffuse BRAINSTEM GLIOMA in children

1/1/2005 (11/24/2004) – 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/pubmed/15565574

http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/abstract;jsessionid=6717837591CCC8FCBD8E46163808E221.d03t01

http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/full
administration of temozolomide after RT DIDN’T ALTER POOR PROGNOSIS associated with newly diagnosed diffuse BRAINSTEM GLIOMA in children

Avastin (Bevacizumab):

5/6/2009 – U.S. Food and Drug Administration (FDA) granted accelerated approval of Avastin (bevacizumab) for people with GLIOBLASTOMA (brain cancer) with progressive disease following prior therapy

effectiveness of Avastin in AGGRESSIVE form of BRAIN CANCER based on improvement in objective response rate

Currently, NO DATA available from randomized controlled trials demonstrating improvement in disease-related symptoms or increased survival with Avastin in GLIOBLASTOMA
http://www.drugs.com/newdrugs/fda-grants-accelerated-approval-avastin-combination-paclitaxel-chemotherapy-first-line-advanced-852.html
According to FDA analysis of study

Study AVF3708g

Study NCI 06-C-0064E
http://www.cancer.gov/cancertopics/druginfo/fda-bevacizumab

http://www.drugs.com/newdrugs/fda-grants-accelerated-approval-avastin-brain-cancer-glioblastoma-has-progressed-following-prior-1342.html
COMPARE COMBINED:

ANAPLASTIC ASTROCYTOMA

22% – Objective Response: Objective response = complete response and partial response – Antineoplastons

22% – response rate: Temodar

11% – Complete Response: Antineoplastons

9% – Complete Response rate: Temodar

17+ years – Maximum Survival : patient with ANAPLASTIC ASTROCYTOMA – Antineoplastons

50 weeks (16-114 weeks) – Median duration of all responses: Temodar

17+ years – Maximum Survival : patient with ANAPLASTIC ASTROCYTOMA – Antineoplastons

64 weeks (52-114 weeks) – Median duration of Complete Response: Temodar

6 months – 7 / 39% Progression-Free Survival: Antineoplastons

4.4 months – Median Progression-Free Survival: Temodar

5 years – 4 / 22% Overall Survival: Antineoplastons

2 years – 7 / 39% Overall Survival: Antineoplastons

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

15.9 months (1 year 3.9 months) – Median Overall Survival: Temodar

COMPARE COMBINED:

GLIOBLASTOMA

39% – Progression-Free Survival (PFS) at 6 months: Antineoplastons

5.28 months – Median Progression-Free Survival (PFS): Antineoplastons

11.3 months – Progression-Free Survival: Avastin

32% – % of Patients Showing Objective Response = complete response and partial response: Antineoplastons

26% – tumor responses observed Avastin

42% – special exception (SE): Overall survival (OS) – 2 years: Antineoplastons

36% – BT-11: Overall survival (OS) – 2 years: Antineoplastons

19% – special exception (SE): Overall survival (OS) – 5 years: Antineoplastons

25% – BT-11: Overall survival (OS) – 5 years: Antineoplastons

4.2 months – Median duration of response in patients: Avastin

9 / 32% – # and % of Patients Showing Objective response = complete response and partial response – Antineoplastons

11 / 20% of patients – Responses were observed: Avastin

5+ years – Maximum Survival : patient with GLIOBLASTOMA – Antineoplastons

3.9 months – Median duration of response: Avastin
https://stanislawrajmundburzynski.wordpress.com/2013/07/28/burzynski-why-has-the-fda-not-granted-accelerated-approval-for-antineoplastons-a10-astengenal-and-as2-1-astugenal/
Do “The Skeptics” believe Burzynski’s data will change from what he’s provided previously, in any FINAL phase 2 pub ?
——————————————————————
2004 – Cited by Burzynski

3/15/1999 – 40 / 30.9% – ARM 1: 1 year Patients Surviving: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997)

3/15/1999 – 17 / 27.0% – ARM 2: 1 year Patients Surviving: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997)

3/15/1999 – 6 months – ARM 1: Median time to Disease Progression: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997)

3/15/1999 – 5 months – ARM 2: Median time to Disease Progression: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997)

3/15/1999 – 8.5 months – ARM 1: Median Overall Survival from start of Treatment (OST): Median time to Death: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997)

3/15/1999 – 8.5 months – ARM 1: Median time to Death: Median Overall Survival from Diagnosis (OSD): Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997)

3/15/1999 – 8 months – ARM 2: Median Overall Survival from Diagnosis (OSD): Median time to Death: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997)

3/15/1999 – 8 months – ARM 2: Median Overall Survival from start of Treatment (OST): Median time to Death: Protocol – easier to treat cases of newly diagnosed BRAIN STEM (tumor) GLIOMA patients: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992–10/1997)

3/15/1999 – 8 months – ARM 2: Median time to Death: radiation therapy and chemotherapy with cisplatin (Mandell et al.) (6/1992 – 10/1997)

3/15/1999 – 8.5 months – Median Survival (MST): standard radiation therapy in combination with chemotherapy (RAT) (Mandell et al.) (6/1992–10/1997) children with newly diagnosed diffuse intrinsic BRAIN STEM TUMORS: results of pediatric oncology group
https://stanislawrajmundburzynski.wordpress.com/2013/08/24/critiquing-httpstheotherburzynskipatientgroup-wordpress-com/
There is no role for hyperfractionated radiotherapy in the management of children with newly diagnosed diffuse intrinsic brainstem tumors: results of a Pediatric Oncology Group phase III trial comparing conventional vs. hyperfractionated radiotherapy
http://www.ncbi.nlm.nih.gov/pubmed/10192340/
======================================
REFERENCES:
======================================
[1] – 3/9/2013 – March 4 at 7:58pm – Colorado Public Television – PBS:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/09/colorado-public-television-pbs/
======================================
[2] – 3/10/2013 – March 5 at 12:25pm – CPT12 – The Cult of “Misinformation”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/11/the-cult-of-misinformation/
======================================
[3] – 3/12/2013 – CPT12 – FACTS Burzynski critics do NOT like:
——————————————————————
[4] – 3/12/2013 – CPT12
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/12/facts-burzynski-critics-do-not-like/
======================================
[5] – 3/17/2013 – Critiquing the Critics on Orac’s Respectful Insolence blog: Part II:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/17/critiquing-the-critics-on-oracs-respectful-insolence-blog-part-ii/
======================================
[6] – 3/24/2013 – “The Skeptics” (Burzynski: Cancer is Serious Business, Part II):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/03/24/the-skeptics/
======================================
[7] – 3/25/2013 – 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/
======================================
[8] – 3/26/2013 – 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/
======================================
[9] – 4/18/2013 – Fact-checking http://thehoustoncancerquack.com
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/18/fact-checking-httpthehoustoncancerquack-com/
======================================
[10] – 4/24/2013 – Burzynski referenced by other Cancer researchers:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/24/burzynski-referenced-by-other-cancer-researchers/
======================================
[11] – 4/24/2013 – 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/
======================================
[12] – 4/24/2013 – Burzynski: Stable Disease:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-stable-disease/
======================================
[13] – 4/24/2013 – Burzynski: Costs of Cancer treatments:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-costs-of-cancer-treatments/
======================================
[14] – 4/27/2013 – Bob Blaskiewicz (Blatherskitewicz), Faux Skeptic Exposed!:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/07/bob-blaskiewicz-blatherskitewicz-faux-skeptic-exposed/
======================================
[15] – 4/19/2013 (4/27/2013-4/28/2013) Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 1):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/27/critiquing-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics-page-1/
======================================
[16] – 4/30/2013 – Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 6):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/30/critiquing-the-skeptic-burzynski-critics-a-film-producer-a-cancer-doctor-and-their-critics-page-6/
======================================
[17] – 5/6/2013 – Critiquing: Is Eric Merola issuing bogus DMCA takedown notices against critics of Stanislaw Burzynski?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/05/07/critiquing-is-eric-merola-issuing-bogus-dmca-takedown-notices-against-critics-of-stanislaw-burzynski/
======================================
[18] – 5/29/2013 (6/2) – Critiquing the #SkepticCanary: “The Skeptics™” (SkeptiCowards©) Bob Blatherskitewicz and the so-called, “self-proclaimed” “CANCER RESEARCHER”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/03/critiquing-the-skepticcanary-the-skeptics-skepticowards-bob-blatherskitewicz-and-the-so-called-self-proclaimed-cancer-researcher/
======================================
[19] – 6/6/2013 – Bob Blaskiewicz (Blatherskitewicz), Faux Skeptic Exposed!:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/07/bob-blaskiewicz-blatherskitewicz-faux-skeptic-exposed/
======================================
[20] – 6/8/2013 – (19. March 29, 1996) – MISDIRECTION: Critiquing “Antineoplastons: Has the FDA kept it’s promise to the American people?”:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/08/what-is-misdirection-critiquing-antineoplastons-has-the-fda-kept-its-promise-to-the-american-people/
======================================
[21] – 6/23/2013 – QUESTIONS the Critics and Cynics, “The Skeptics™” do NOT want to ANSWER:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/06/23/questions-the-critics-and-cynics-the-skeptics-do-not-want-to-answer/
======================================
[ 22] – 7/2/2013 –
Burzynski: Institutional Review Board (IRB):
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/02/burzynski-institutional-review-board-irb/
======================================
[23] – 7/31/2013 – Perfessor Robert J. (Bob) Blaskiewicz Blatherskitewicz:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/31/the-burzynski-b-s-app/
======================================
[24] – 8/18/2013 – The Burzynski Skeptics:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/18/the-burzynski-skeptics/
======================================
[25] – 8/25/2013 – Critiquing https://theotherburzynskipatientgroup.wordpress.com
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/24/critiquing-httpstheotherburzynskipatientgroup-wordpress-com/
======================================
[26] – 8/26/2013 – Yes! Weekly: Burzynski: Cancer is Serious Business Part II:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/08/26/yes-weekly-burzynski-cancer-is-serious-business-part-ii/
======================================
“Orphan Drug”
phenylbutyrate
PB
“Orphan Drug”
phenylacetate
PN
Orphan Drug”
phenylacetylglutamine
“Orphan Drug”
phenylacetylisoglutimine
PG
“Orphan Drug”
phenylacetylisoglutiminate
PG
2011 – Orphan Drugs in Development
http://www.phrma.org/sites/default/files/pdf/rarediseases2011.pdf

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020645s000_ClinPharmR.pdf

http://www.hrsa.gov/opa/programrequirements/orphandrugexclusion/orphandruglist.pdf

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2764862/
Phenylbutyrate is a aromatic fatty acid, able to induce hyperacetylation of histones H3 and H4 and growth arrest, differentiation and apoptosis of AML cell lines and primary leukemic cells. It has been effectively used to induce fetal erythropoiesis in patients with sickle cell anemia and β-thalassemia [105]. The aromatic ring does not contribute to the antitumor activity, as butyric acid is of equal or greater potency at producing these biological changes, while shortening of the fatty acid carbon chain length, as demonstrated with phenylacetate, significantly diminished drug potency [106]. After administration phenylbutyrate is metabolized to phenylacetate, then to phenylacetylglutamine and eliminated by urine [107]. The maximum tolerated doses, when administered as a 7-day continuous infusion, was 375 mg/kg/day, while higher doses were associated with encephalopathy apparently attributable to accumulation of the metabolite phenylacetate. At the maximum tolerated dose (MTD), median steady state concentration of phenylbutyrate is 0.3 mM, which is less than the ED50 of 1-2 mM required for differentiation and cytostasis in vitro but in within the concentration range in which phenylbutyrate
induces acetylation of histones. Dose-limiting toxicities were mainly represented by neurocortical toxicity, including lethargy, confusion, and slurred speech, which completely disappeared within 24 to 48 h upon cessation of the infusion. Non dose-limiting toxicities were hyperammoniemia, hyperuricemia, hypocalcemia, skin abnormalities and interstitial pneumonia [108, 109].
Bobby Blaskiewicz Bows Up ‘Bout Burzynski;
https://stanislawrajmundburzynski.wordpress.com/2013/09/24/bobby-blaskiewicz-bows-up-bout-burzynski/

Advertisement

Does David H. “Orac” Gorski, M.D., Ph.D, really CARE about Breast Cancer patients?

Dr. Gorski (@gorskon @OracKnows @ScienceBasedMed
http://www.scienceblogs.com/Insolence
#ScienceBasedMedicine
http://www.sciencebasedmedicine.org)
is advertised as being a “Breast Cancer Specialist”

The question is, does he really CARE about Breast Cancer patients?

2000-2001, clinical studies were conducted on breast cancer patients in Egypt, using antineoplaston A10
======================================
Burzynski: Egypt antineoplaston publications:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-egypt-antineoplaston-publication/
======================================
7/3/2000 they noted:
——————————————————————
Antineoplastons first described by Burzynski are naturally occurring peptides and amino acid derivatives, which control neoplastic growth
——————————————————————
Antineoplaston A-10 level measured in urine of:
31 breast cancer patients
17 normal women
——————————————————————
Significantly lower antineoplaston A-10 levels detected among patients with breast cancer
——————————————————————
Data suggest strong inverse association of urinary antineoplaston A-10 level with breast cancer
——————————————————————
Potential utility of antineoplaston A-10 as predictive test for women at risk of developing breast cancer
======================================
8/31/2000 they noted:
—————————————————————
Antineoplastons are naturally occurring cytodifferentiating agents
—————————————————————
Chemically, they are medium and small sized peptides, amino acid derivatives and organic acids, which exist in blood, tissues and urine
—————————————————————
Findings confirm presence of immune defects among patients with breast cancer and results should stimulate development of new strategies to induce and augment immunity for treatment of breast cancer
—————————————————————
Antineoplaston A-10 may provide rational basis for designing trials to employ its immune modulatory potentials as adjuvant therapy in breast cancer patients
======================================
12/2000 they noted:
—————————————————————
4 new piperidinedione A10 analogs synthesized and tested for antimitotic activity on human breast cancer cell line against prototype A10 and antibreast cancer drug tamoxifen
—————————————————————
DNA binding capacity of compounds evaluated against A10
—————————————————————
“3A” and “3C” had weaker biological profiles than lead compound A10
—————————————————————
“3B” and “3D” were several-fold more potent antiproliferative agents than A10 and tamoxifen and had significantly higher capacity to bind DNA than A10
======================================
10/1/2001 they noted:
—————————————————————
Reports on structural characterization of new antineoplaston (ANP) representatives
—————————————————————
Combination heat with pH modification had virtually no effect on obtained peaks, attesting to stability and purity of compounds
—————————————————————
One had superior affinity to DNA than prototype ANP-A10
======================================
8/2005 Antineoplastons such as A10 include naturally occurring peptides and amino acid derivatives that CONTROL NEOPLASTIC GROWTH OF CELLS
——————————————————————
Findings indicate antineoplaston A10 ANTITUMOR EFFECT could be utilized as effective therapy for breast cancer patients
——————————————————————
Antineoplaston induces G1 arrest by PKCα and MAPK pathway in SKBR-3 breast cancer cells
Hideaki H TSUDA Antineoplaston A10
http://www.ncbi.nlm.nih.gov/pubmed/16012735
Antineoplaston induces G1 arrest by PKCo and MAPK pathway in SKBR-3 breast cancer cells
http://www.ncbi.nlm.nih.gov/m/pubmed/16012735
Antineoplaston induces G(1) arrest by PKCalpha and MAPK pathway in SKBR-3 breast cancer cells
http://www.spandidos-publications.com/or/14/2/489
Oncol Rep. 8/2005; 14(2):489-94
http://gyouseki.kurume-u.ac.jp/PDF/ichiran_2005.pdf
Oncol Rep 14(2):489-94 (2005)
http://research.kurume-u.ac.jp/K90RES.php?scode=49485632873864
Oncol Rep. 2005; 14:489–94
http://onlinelibrary.wiley.com/doi/10.1002/iub.574/abstract
Oncol. Rep. 14, 489–494
http://onlinelibrary.wiley.com/doi/10.1002/iub.574/full
Oncology Reports, 8/2005, Volume 14 Number 2
Pages: 489-494
http://onlinelibrary.wiley.com/store/10.1002/iub.574/asset/574_ftp.pdf?v=1&t=hbr9z60q&s=0b1c1e8655db9c54b45dbf72062e8b11cb7895ac
Oncology Reports, Spandidos Publications
Department of Surgery, Kurume University School of Medicine, Kurume, Fukuoka, Japan
======================================
� � � � � � � � � � � � � � � �
1/2008 Novel mechanism through which all-trans retinoic acid (ATRA) and antineoplaston, ANTICANCER DRUG, CAUSED CELL GROWTH INHIBITION IN BREAST CANCER CELLS through effects on intracellular pathways
——————————————————————
Antineoplaston caused down-regulation of PKCalpha protein expression, resulting in INHIBITION of ERK MAPK phosphorylation, with resultant INHIBITION of Rb phosphorylation leading to G(1) arrest

Preclinical studies of molecular-targeting diagnostic and therapeutic strategies against breast cancer
http://www.ncbi.nlm.nih.gov/pubmed/18224398
antineoplaston
http://www.ncbi.nlm.nih.gov/m/pubmed/18224398
Breast Cancer 15(1):73-8 (2008)
DOI: 10.1007/s12282-007-0015-y
http://link.springer.com/article/10.1007%2Fs12282-007-0015-y
15(1):73-8
http://www.springerlink.com/content/p724x34746l56v73
Department of Surgery, Kurume University, Fukuoka, Japan
http://ci.nii.ac.jp/naid/10021288533
======================================
Burzynski has made it clear that:

… antineoplaston A10 rather than antineoplaston AS2-1 is main active drug
—————————————————————
Pg. 99
—————————————————————
http://www.burzynskiclinic.com/images/stories/Publications/960.pdf
—————————————————————
Burzynski has been using the “Parent” generation of antineoplastons in the phase II clinical trials, and could NOT just switch to new antineoplaston analogs which may produce better results

Also, Burzynski has made it clear that successive generations of antineoplastons have been developed which may also produce better results
—————————————————————
To those who seemed to think Burzynski’s phase II clinical trials were taking too long, he was following science based medicine’s:
—————————————————————
Pg. 94
—————————————————————
2-stage phase II clinical trial design proposed by Fleming [3]
—————————————————————
Pg. 100 References
—————————————————————
3. Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics 1982; 38: 143-51
http://www.ncbi.nlm.nih.gov/pubmed/7082756/
Biometrics. 1982 Mar;38(1):143-51
http://www.ncbi.nlm.nih.gov/m/pubmed/7082756/
Biometrics Vol. 38, No. 1, Mar., 1982
http://www.jstor.org/discover/10.2307/2530297?uid=3739656&uid=2460338175&uid=2460337855&uid=2&uid=4&uid=83&uid=63&uid=3739256&sid=21102549294733
—————————————————————
To those who have made ridiculous statements to the effect that Burzynski is a murderer, and ignore that he has dealt with patients whom science based medicine’s chemotherapy therapy and / or radiation therapy did NOT work, what’s the difference when science based medicine fails?
——————————————————————
33 / 100% – DIED OF DISEASE PROGRESSION
——————————————————————
2004 – Supratentorial high-grade ASTROCYTOMA and DIFFUSE BRAINSTEM GLIOMA:
——————————————————————
two challenges for the pediatric oncologist
http://www.ncbi.nlm.nih.gov/pubmed/15047924/
Oncologist. 2004;9(2):197-206
http://www.ncbi.nlm.nih.gov/m/pubmed/15047924/
Oncologist 9, 197-206
http://m.theoncologist.alphamedpress.org/content/9/2/197.long
Division of Neuro-Oncology, Department of Hematology-Oncology, St. Jude Children’s Research Hospital, Memphis, Tennessee, USA
======================================
David James (@StortSkeptic) tweeted at 7:08pm – 1 Aug 13:

The new Doctor Who will be Stanislaw #Burzynski. He manages to continually avoid getting cornered and he gets away with murder.
https://twitter.com/StortSkeptic/status/363088970239840256
—————————————————
To those who say that antineoplastons are toxic, what is the difference with science based medicine’s chemotherapy therapy or radiation therapy when we know that NOT all patients will experience all possible side-effects of a drug?

The successive generations of antineoplastons may be even better and have less potential side-effects
=====================================
10/1/2010 As degradation product of Antineoplaston A10 in vivo, PHENYLACETYL GLUTAMINE showed ANTITUMOR ACTIVITIES
——————————————————————
Designed and radiosynthesized PHENYLACETYL GLUTAMINE derivative, achieved under mild reaction condition
——————————————————————
radiochemical purity of (S)-2-((S)-2-(4-(3-fluoropropyl)benzamido)-3-phenylpropanamido)pentanedioic acid ([18F]FBPPA) was 98%, and best radiochemical yield was up to 46%
——————————————————————
results revealed it might become potential PET imaging agent for DETECTING TUMORS
——————————————————————
Antineoplaston A10 phenylacetyl glutamine (PG) – (S)-2-((S)-2-(4-(3-[18F]fluoropropyl)benzamido)-3-phenylpropanamido)pentanedioic acid labeled with 18F
http://www.springerlink.com/content/tj0177485773007t
(S)-2-((S)-2-(4-(3-[18 F] fluoropropyl) benzamido)-3-phenylpropanamido) pentanedioic acid labeled with 18 F
http://link.springer.com/article/10.1007%2Fs10967-010-0633-2?LI=true
Journal of Radioanalytical and Nuclear Chemistry, 2010, 286, 1, 135
http://www.springerlink.com/content/tj0177485773007t
October 2010, Volume 286, Issue 1, pp 135-140
http://link.springer.com/article/10.1007%2Fs10967-010-0633-2
DOI
10.1007/s10967-010-0633-2
http://link.springer.com/article/10.1007/s10967-010-0633-2/fulltext.html
Burzynski References: 5. – 6.
http://onlinelibrary.wiley.com/doi/10.1021/js960120y/abstract

http://www.springerlink.com/content/tj0177485773007t
======================================
Antineoplastons as a blood or urine “cancer test”:
—————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/02/22/antineoplastons-as-a-blood-or-urine-cancer-test/
======================================

Burzynski: Why has the FDA NOT granted Accelerated Approval for Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal) ?

======================================
1996 – Accelerated approval started by United States Food and Drug Administration Commissioner, Dr. David A. Kessler
(.4:18 – .6:10):
http://www.youtube.com/watch?v=1buiXWr_QTQ
======================================
Tamoxifen:
======================================
7/1997 – A phase I study of high-dose tamoxifen for the treatment of refractory malignant GLIOMAS OF CHILDHOOD
http://www.ncbi.nlm.nih.gov/pubmed/9815790/
Clin Cancer Res. 1997 Jul;3(7):1109-15
http://www.ncbi.nlm.nih.gov/m/pubmed/9815790/
Clin Cancer Res July 1997 3; 1109
http://m.clincancerres.aacrjournals.org/content/3/7/1109.full.pd
Departments of Neurosurgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA

http://clincancerres.aacrjournals.org/content/3/7/1109
Children with malignant GLIOMAS THAT PROGRESSED AFTER CONVENTIONAL THERAPY
——————————————————————
0 / 0% – EXHIBITED CLEAR-CUT TUMOR regression
——————————————————————
17 months (1 year 5 months) – longest survivor lived for after beginning tamoxifen
======================================
2000 – Radiation therapy and high-dose tamoxifen in the treatment of patients with diffuse BRAINSTEM GLIOMAS:

results of a Brazilian cooperative study
http://www.ncbi.nlm.nih.gov/pubmed/10715294/
Brainstem Glioma Cooperative Group
http://www.ncbi.nlm.nih.gov/m/pubmed/10715294/
J Clin Oncol 18, 1246-1253
http://m.jco.ascopubs.org/content/18/6/1246.long
——————————————————————
22 – assessable patients
——————————————————————
10.3 months – Median Survival
——————————————————————
4 / 18% – remain alive without tumoral progression
——————————————————————
8 / 37.0% {+/- 2 / 9.5%} (mean +/- SD) – 1-year Survival rate
——————————————————————
treatment combination PRODUCED NO SIGNIFICANT CHANGE in overall POOR prognosis of patients

Most tumors responded initially to treatment but recurred as study progressed

Based on POOR RESULTS, recommend ALTERNATIVE TREATMENTS be tested in patients with this type of tumor
======================================
Temodar (Temozolomide):
======================================
Temozolomide received accelerated approval by the U.S. Food and Drug Administration 1/1999 for treatment of ANAPLASTIC ASTROCYTOMA (brain cancer) patients
——————————————————————
54 patients
——————————————————————
12 / 22% – response rate
——————————————————————
5 / 9% – Complete Response rate
——————————————————————
50 weeks (16-114 weeks) – Median duration of all responses
——————————————————————
64 weeks (52-114 weeks) – Median duration of Complete Response
——————————————————————
4.4 months – Median Progression-Free Survival
——————————————————————
15.9 months (1 year 3.9 months) – Median Overall Survival
——————————————————————
At time of approval, NO RESULTS were available from randomized controlled trials in refractory ANAPLASTIC ASTROCYTOMA that show clinical benefit such as improvement in disease-related symptoms or prolonged survival
——————————————————————
http://clincancerres.aacrjournals.org/content/11/19/6767.full
======================================
Was the United States Food and Drug Administration’s 1/1999 accelerated approval based on the PUBLISHED FINAL RESULTS OF A PHASE II (2) CLINICAL TRIAL?
======================================
12/2000 – Temozolomide and ANAPLASTIC ASTROCYTOMA:

new indication

NO CLEAR PROOF OF EFFICACY
http://www.ncbi.nlm.nih.gov/pubmed/11475493/
Prescrire Int. 2000 Dec;9(50):170-1.
http://www.ncbi.nlm.nih.gov/m/pubmed/11475493/
(1) Temozolomide recently licensed in France for treating patients with ANAPLASTIC ASTROCYTOMA who are in relapse or progression after standard therapy
——————————————————————
(2) clinical dossier contains only one non comparative trial
——————————————————————
(3) 111 patients with ANAPLASTIC ASTROCYTOMA or oligoanaplastic astrocytoma had not all had the standard treatment with surgery, radiotherapy and chemotherapy
——————————————————————
54 patients – subgroup who met criteria
——————————————————————
16 months (1 year 4 months) – Median Global Survival
——————————————————————
31 months (2 years 7 months) – Median Global Survival from start of initial treatment
——————————————————————
NO BETTER THAN SURVIVAL BEFORE THE INTRODUCTION OF temozolomide
======================================
The answer is: NO

1/1999 – FDA Accelerated Approval
9/1999 – Phase 2 publication
======================================
9/1999 – Multicenter phase II trial of temozolomide in patients with ANAPLASTIC ASTROCYTOMA or anaplastic oligoastrocytoma at first relapse

Temodal Brain Tumor Group
http://www.ncbi.nlm.nih.gov/pubmed/10561351/
J Clin Oncol. 1999 Sep;17(9):2762-71.
http://www.ncbi.nlm.nih.gov/m/pubmed/10561351/
University of Texas M.D. Anderson Cancer Center, Houston, TX, USA
======================================
http://www.drugs.com/pro/temodar.html
======================================
http://www.pharmainfo.net/fda-articles/fda-safety-page-fatal-medication-errors-associated-temodar
======================================
TEMODAR ADVERSE EVENTS REPORTED TO THE FDA OVER TIME:
http://www.drugcite.com/?q=TEMODAR
======================================
ADVERSE EVENTS:
Primary Suspect Reports: 4,436
Total Reports: 6,350
http://www.adverseevents.com/drugdetail.php?AEDrugID=1794&BrandName=TEMODAR
======================================
http://www.temodar.com/temodar/index.do
======================================
2004 – Supratentorial high-grade ASTROCYTOMA and DIFFUSE BRAINSTEM GLIOMA:

two challenges for the pediatric oncologist
http://www.ncbi.nlm.nih.gov/pubmed/15047924/
Oncologist. 2004;9(2):197-206.
http://www.ncbi.nlm.nih.gov/m/pubmed/15047924/
Oncologist 9, 197-206
http://m.theoncologist.alphamedpress.org/content/9/2/197.long
Division of Neuro-Oncology, Department of Hematology-Oncology, St. Jude Children’s Research Hospital, Memphis, Tennessee, USA

neoplasms predominantly involve supratentorial hemispheres or pons, in which case tumors are usually called DIFFUSE BRAINSTEM GLIOMAS

supratentorial neoplasms
——————————————————————
diagnosis of DIFFUSE BRAINSTEM GLIOMA based upon typical imaging, dispensing with need for surgery in majority of cases

Radiation therapy is mainstay of treatment for children with DIFFUSE BRAINSTEM GLIOMAS
——————————————————————
2 years – Less than 10% of children with diffuse brainstem gliomas survive
——————————————————————
outcome for patients with either type of tumor is POOR when standard multimodality therapy is used

children are ideal candidates for INNOVATIVE TREATMENT approaches
——————————————————————
3-21 years Patients were eligible for current multiinstitutional study
——————————————————————
33 patients (6.4 years – Median age at diagnosis) enrolled
——————————————————————
33 / 100% – DIED OF DISEASE PROGRESSION
——————————————————————
12 months (1 year) – Median Survival
——————————————————————
16 / 48% – estimated 1-year Survival rate (standard error, 1 / 8%)
——————————————————————
administration of temozolomide after RT DIDN’T ALTER POOR PROGNOSIS associated with newly diagnosed diffuse BRAINSTEM GLIOMA in children
======================================
1/1/2005 (11/24/2004) – 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/pubmed/15565574
Cancer. 2005 Jan 1;103(1):133-9.
http://www.ncbi.nlm.nih.gov/m/pubmed/15565574
Cancer 103, 133-139
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/abstract;jsessionid=6717837591CCC8FCBD8E46163808E221.d03t01
Cancer
Volume 103, Issue 1, pages 133–139, 1 January 2005
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/full
Article first published online: 24 NOV 2004
References:
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/references
Cited By:
http://onlinelibrary.wiley.com/doi/10.1002/cncr.20741/citedby
DOI: 10.1002/cncr.20741

Department of Hematology-Oncology, St. Jude Children’s Research Hospital, Memphis, Tennessee, USA
——————————————————————
33 patients: (33 / 100% – 6.4 years: Median age)
——————————————————————
33 / 100% – ALL DIED OF DISEASE PROGRESSION
——————————————————————
12 months (1 year) – Median Survival
——————————————————————
16 / 48% – 1 year estimated Survival rate
——————————————————————
Table 1. Results of radiation therapy in combination with chemotherapy for newly diagnosed, diffuse, intrinsic BRAIN STEM GLIOMA

Author
Study Type
Patients Total No.
Treatment Radiation Therapy
Additional Chemotherapy
Efficacy
OS MST CR PR SD PD

Multiinstitutional 33 56 Temozolomide, irinotecan 0 0 12 NA NA NA

response rates based on evaluable patients
32 54 Topotecan

CR – complete response
GCSF – granulocyte colony stimulating factor
HD – high dose tamoxifen
HDB – high dose chemotherapy and autologous bone marrow transplantation HF – hyperfractionated
M – months
MST – median survival time
NA – not available
OS – overall survival
PD – progressive disease
PR – partial response
SD – stable disease
UNK – unknown
* 1 patient had radiological improvement

Cancer 103, 133-139
——————————————————————
3-21 years – eligible for current multiinstitutional study
——————————————————————
33 – (Median age at diagnosis
6.4 years) enrolled
——————————————————————
ALL PATIENTS DIED OF DISEASE PROGRESSION
——————————————————————
12 months (1 year) – Median Survival
——————————————————————
48% – estimated 1-year Survival rate (standard error 8%)
——————————————————————
administration of temozolomide after RT DIDN’T ALTER POOR PROGNOSIS associated with newly diagnosed diffuse BRAINSTEM GLIOMA in children
======================================
2/2008 (2/2/2007)
Treatment of children with diffuse intrinsic BRAIN STEM GLIOMA with radiotherapy, vincristine and oral VP-16:

a Children’s Oncology Group phase II study
http://www.ncbi.nlm.nih.gov/pubmed/17278121
Pediatr Blood Cancer. 2008 Feb;50(2):227-30
http://www.ncbi.nlm.nih.gov/m/pubmed/17278121
University of Rochester Medical Center, Rochester, New York, USA.

http://onlinelibrary.wiley.com/doi/10.1002/pbc.21154/abstract;jsessionid=DE7A67EFBAC1A184F6805F11CFC4F30B.d02t02
Article first published online: 2 FEB 2007
DOI: 10.1002/pbc.21154

prognosis for children with BRAIN STEM GLIOMA remains grim

The Pediatric Oncology Group (POG, now part of Children’s Oncology Group) conducted study using agents in combination with standard external beam radiation for children with newly diagnosed BRAIN STEM GLIOMA
——————————————————————
Children eligible
3-21 years of age, had MRI-evidence of diffuse intrinsic pontine glioma, and had neurologic deficits of <6 months duration
——————————————————————
30 eligible and evaluable for Survival / toxicity
——————————————————————
8 years (3-14 years) – Median age
——————————————————————
7 / 23% – Partial Response following radiation
18 / 60% – Stable Disease
2 / 7% – Progressive Disease
3 / 10% – Response Not measured
——————————————————————
30 / 100% CHILDREN DIED
——————————————————————
Overall Survival 1 year
27 +/- 7%
2 years, 3 +/- 2%
——————————————————————
9 months (3-36 months) – Median Survival
——————————————————————
addition of vincristine and oral VP-16 to standard external beam radiation causes moderate toxicity and DOESN’T IMPROVE SURVIVAL OF CHILDREN WITH DIFFUSE INTRINSIC BRAIN STEM GLIOMA
======================================
Avastin (Bevacizumab):
======================================
5/6/2009 – U.S. Food and Drug Administration (FDA) granted accelerated approval of Avastin (bevacizumab) for people with GLIOBLASTOMA (brain cancer) with progressive disease following prior therapy

effectiveness of Avastin in AGGRESSIVE form of BRAIN CANCER based on improvement in objective response rate

Currently, NO DATA available from randomized controlled trials demonstrating improvement in disease-related symptoms or increased survival with Avastin in GLIOBLASTOMA
——————————————————————
11.3 months – Progression-Free Survival
——————————————————————
http://www.drugs.com/newdrugs/fda-grants-accelerated-approval-avastin-combination-paclitaxel-chemotherapy-first-line-advanced-852.html
According to FDA analysis of study

Study AVF3708g
——————————————————————
22 / 26% – tumor responses observed of 85 patients treated with Avastin alone
——————————————————————
4.2 months – Median duration of response in patients
——————————————————————
Study NCI 06-C-0064E

Efficacy of Avastin in GLIOBLASTOMA that progressed following prior therapy supported by another study that used same response assessment criteria as AVF3708g

56 patients treated with Avastin alone
——————————————————————
11 / 20% of patients – Responses were observed
——————————————————————
3.9 months – Median duration of response
——————————————————————
http://www.cancer.gov/cancertopics/druginfo/fda-bevacizumab
FDA – “People with this type of brain cancer have had no new treatments in more than a decade”
http://www.drugs.com/newdrugs/fda-grants-accelerated-approval-avastin-brain-cancer-glioblastoma-has-progressed-following-prior-1342.html
——————————————————————
Avastin is gene-targeted therapy, which can only target certain specific genes
======================================
Afinitor (Everolimus):
======================================
Afinitor (ubependymal giant cell ASTROCYTOMA (SEGA) brain tumor)
——————————————————————
10/29/2010 – FDA granted accelerated approval for Afinitor after single Phase 2 study of only 28 patients
——————————————————————
32% experienced 50% reduction of tumor
——————————————————————
none of their tumors went away completely
======================================
Was the United States Food and Drug Administration’s 10/29/2010 accelerated approval based on the PUBLISHED FINAL RESULTS OF A PHASE II (2) CLINICAL TRIAL?
======================================
10/12/2011 (8/1/2011) – Everolimus tablets for patients with subependymal giant cell ASTROCYTOMA
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3389821/
Expert Opin Pharmacother. Author manuscript; available in PMC 2012 July 5.
Published in final edited form as:
Expert Opin Pharmacother. 2011 October; 12(14): 2265–2269.
Published online 2011 August 1. doi: 10.1517/14656566.2011.601742
PMCID: PMC3389821
NIHMSID: NIHMS385824
——————————————————————
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm231967.htm
======================================
The answer is: NO

10/29/2010 – FDA Accelerated Approval
10/12/2011 – publication
� � � � � � � � � � � � � � � � �
COMPARE COMBINED:
� � � � � � � � � � � � � � � � �
======================================
ANAPLASTIC ASTROCYTOMA
==========================
22% – Objective Response: Objective response = complete response and partial response – Antineoplastons
�
22% – response rate: Temodar
——————————————————————
11% – Complete Response: Antineoplastons
�
9% – Complete Response rate: Temodar
——————————————————————
17+ years – Maximum Survival : patient with ANAPLASTIC ASTROCYTOMA – Antineoplastons
�
50 weeks (16-114 weeks) – Median duration of all responses: Temodar
——————————————————————
17+ years – Maximum Survival : patient with ANAPLASTIC ASTROCYTOMA – Antineoplastons
�
64 weeks (52-114 weeks) – Median duration of Complete Response: Temodar
——————————————————————
6 months – 7 / 39% Progression-Free Survival: Antineoplastons
�
4.4 months – Median Progression-Free Survival: Temodar
——————————————————————
5 years – 4 / 22% Overall Survival: Antineoplastons
�
2 years – 7 / 39% Overall Survival: Antineoplastons
�
2 years – Most patients with brainstem glioma fail standard radiation therapy and chemotherapy and do not survive longer
�
15.9 months (1 year 3.9 months) – Median Overall Survival: Temodar
� � � � � � � � � � � � � � � � �
COMPARE COMBINED:
� � � � � � � � � � � � � � � � �
======================================
GLIOBLASTOMA
======================================
39% – Progression-Free Survival (PFS) at 6 months: Antineoplastons
�
5.28 months – Median Progression-Free Survival (PFS): Antineoplastons
�
11.3 months – Progression-Free Survival: Avastin
——————————————————————
32% – % of Patients Showing Objective Response = complete response and partial response: Antineoplastons
�
26% – tumor responses observed Avastin
——————————————————————
42% – special exception (SE): Overall survival (OS) – 2 years: Antineoplastons
�
36% – BT-11: Overall survival (OS) – 2 years: Antineoplastons
�
19% – special exception (SE): Overall survival (OS) – 5 years: Antineoplastons
�
25% – BT-11: Overall survival (OS) – 5 years: Antineoplastons
�
4.2 months – Median duration of response in patients: Avastin
——————————————————————
9 / 32% – # and % of Patients Showing Objective response = complete response and partial response – Antineoplastons
�
11 / 20% of patients – Responses were observed: Avastin
——————————————————————
5+ years – Maximum Survival : patient with GLIOBLASTOMA – Antineoplastons
�
3.9 months – Median duration of response: Avastin
� � � � � � � � � � � � � � � � �
COMPARE COMBINED:
� � � � � � � � � � � � � � � � �
======================================
ASTROCYTOMA
======================================
47% / 7 – % and # of Patients Showing Objective response = complete response (6) and partial response (1) – Antineoplastons
�
32% experienced 50% reduction of tumor – Afinitor
� � � � � � � � � � � � � � � � �
Burzynski: Complete Response, Partial Response, Stable Disease, Progressive Disease, Objective Response, and Response:
https://stanislawrajmundburzynski.wordpress.com/2013/07/04/burzynski-complete-response-partial-response-stable-disease-progressive-disease-objective-response-and-response/
� � � � � � � � � � � � � � � � �
Burzynski: Progression-Free Survival:
https://stanislawrajmundburzynski.wordpress.com/2013/07/04/burzynski-progression-free-survival/
� � � � � � � � � � � � � � � � �
WHAT IS MISDIRECTION ? Critiquing “Antineoplastons: Has the FDA kept its promise to the American people ?”:
https://stanislawrajmundburzynski.wordpress.com/2013/06/08/what-is-misdirection-critiquing-antineoplastons-has-the-fda-kept-its-promise-to-the-american-people/
� � � � � � � � � � � � � � � � �