All’s fair in Drugs and War

(4/1998 – 8/2003)
United States alleges GSK participated in

misleading medical journal article that misreported that clinical trial of drug demonstrated efficacy in treatment when study failed to demonstrate efficacy
At same time, United States alleges, GSK didn’t make available data from 2 other studies in which drug also failed to demonstrate efficacy
(2001 – 2007)
United States alleges GSK failed to include certain safety data about drug in reports to FDA meant to allow FDA to determine if drug continues to be safe for approved indications and to spot drug safety trends
missing information included data regarding certain post-marketing studies
data regarding 2 studies undertaken in response to European regulators’ concerns about safety of drug
United States alleges GSK stated drug had positive cholesterol profile despite having no well-controlled studies to support that message

Johnson & Johnson (J&J) and subsidiaries, Janssen Pharmaceuticals Inc. and Scios Inc.
Janssen Pharmaceutica Products, L.P.
$2.2 BILLION +
11/4/2013, Monday
Johnson & Johnson (J&J) and Janssen
complaint alleges J&J and Janssen were aware drug posed serious health risks, but companies downplayed these risks
For example, when J&J study of drug showed significant risk of strokes and other adverse events in patients, complaint alleges Janssen combined study data with other studies to make it appear there was lower overall risk of adverse events
year after J&J received results of 2nd study confirming increased safety risk for patients taking drug, but hadn’t published data, one physician who worked on study cautioned Janssen
“[a]t this point, so long after [the study] has been completedwe must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”
complaint alleges Janssen knew patients taking drug had increased risk, but nonetheless promoted drug as “uncompromised by safety concerns
When Janssen received initial results of studies indicating drug posed same risk as other antipsychotics, complaint alleges company retained outside consultants to re-analyze study results and ultimately published articles stating drug was actually associated with lower risk
J&J and another of its subsidiaries, Scios Inc.
8/2001 – FDA approved drug to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity
approval based on study involving hospitalized patients experiencing severe heart failure who received infusions of drug over average 36-hour period
complaint alleged Scios had no sound scientific evidence supporting medical necessity of outpatient infusions and misleadingly used small pilot study to encourage serial outpatient use of drug

Abbott Laboratories Inc.
5/7/2012, Monday
(2001 – 2006)
company marketed drug in combination with atypical antipsychotic drugs even after its clinical trials failed to demonstrate adding drug was any more effective than atypical antipsychotic alone for that use
1999 – forced to discontinue clinical trial of drug due to increased incidence of adverse events, including
experienced by study participants administered drug
funded 2 studies of use of drug
both failed to meet main goals established for the study
When 2nd study failed to show statistically significant treatment difference between antipsychotic drugs used in combination with drug and antipsychotic drugs alone, waited nearly 2 years to notify sales force about study results and another 2 years to publish results

AstraZeneca LP / AstraZeneca Pharmaceuticals LP
4/27/2010, Tuesday
engaged doctors to conduct studies on unapproved uses of drug
recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies doctors in question didn’t conduct
then used

as basis for promotional messages about unapproved uses of drug
11/26/2013 – United States Department of Justice (DOJ) versus BIG Pharma: BIG Pharma fought the law, and the law won ?:

Critiquing: Families run out of hope, money after cancer treatments (USA TODAY NEWS, NATION, Liz Szabo, USA TODAY)

Liz Szabo
Michael Stravato
Jerry Mosemak
Robert Hanashiro

Before you write a Hack Piece
Check Your Facts Please


The 3rd, and thankfully final segment of USA TODAY’s “hit-piece” of irresponsible yellow journalism about Dr. Stanislaw R. Burzynski [1], contains the following:
“Patients stay in hotels while visiting him”
Pete Cohen made this movie about his and
Hannah Bradley’s trip to the Burzynski Clinic

It does NOT look like they stayed in a hotel [2]
The article continues:
“If children deteriorate, they often end up in the closest emergency room, said physician Jeanine Graf, director of the pediatric intensive care unit at Texas Children’s Hospital in Houston, who says she has treated at least a dozen of Burzynski’s patients
In the 2nd segment of USA TODAY’s yellow journalism “hit-piece,” the reader was advised that Burzynski had treated [3]:
“ . . . more than 8,000 patients since 1977.”
Physician Jeanine Graf, “says she has treated at least a dozen of Burzynski’smore than 8,000 patients,”

This means that Dr. Graf has treated LESS THAN 0.15% of Burzynski’s patients
The article indicates that:
“Typically, Graf sees Burzynski’s patients after they have become unresponsive, unable to open their eyes or breathe on their own”

“Graf says she’s never seen Burzynski attending to them”
Why would she ?

Does she ride in the ambulance to and from the clinic ?

As the article makes clear:

“While Burzynski often meets patients on their first trip to the clinic, Jaffe said he is

“not the treating physician of the clinic’s patients”

“The doctors on Burzynski’s staff have admitting privileges at local hospitals and “attend to patients as needed,” Jaffe said”
And she continues:
“And describing her personal experience with Burzynski’s patients, Graf says,”

“I’ve never seen one survive long-term.”
Are we supposed to believe that pediatric physician Jeanine Graf keeps track of the “more than 8,000 patients” that the article claims Burzynski has treated ?
Continuing on, the article also claims:
“The unlucky ones end up broke, spending everything on medicine, airfare, hotel rooms and meals while in Houston, Graf says

“Burzynski’s attorney, Richard Jaffe, notes that all cancer care is expensive”

“I think the clinic’s policies are a lot more charitable than the big institutions,” Jaffe says”
6/25/2013 – Medical Bills Are the Biggest Cause of US Bankruptcies [4]

“Bankruptcies resulting from unpaid medical bills will affect nearly 2 million people this year—making health care the No. 1 cause of such filings . . . according to new data”

“. . . estimates that households containing 1.7 million people will file for bankruptcy protection this year

“Even outside of bankruptcy, about 56 million adultsmore than 20 percent of the population between the ages of 19 and 64—will still struggle with health-care-related bills this year . . .”

“Despite the anticipated 2013 dip, such bankruptcies represent about three out of every five filings
2007 – How Many Americans Go Bankrupt Due to Medical Purposes Each Year? [5]

“2007, a Harvard study shows that at least 60% of bankruptcies are related to medical bills

“Even people with health insurance are filing bankruptcy”

“Insurance premiums, deductibles, co-pay, and out of pocket expenses cause medical bills to drown individuals and families in medical debt”

“Harvard also discovered that 75% of those filing bankruptcy for medical reasons had health insurance

“It is clear that having health insurance is no guarantee against carrying debt related to health care”
Burzynski has treated more than 8,000 patients since 1977

8,000 divided by 36 years equals an average of:

222 patients per year

Burzynski is obviously NOT the problem
Liz Szabo, Michael Stravato, Jerry Mosemak, and Robert Hanashiro

Don’t quit your day jobs

USA TODAY needs to generate readership somehow !!!
Sarcasm . . . deal with it
[1] – 11/15/2013
[2]Hannah’s Anectdote:

[3] – 11/16/2013 – Critiquing: Doctor accused of selling false hope to families (USA TODAY NEWS, NATION, Liz Szabo, USA TODAY):
[4] – 06/25/13 2:29 PM ET—By CNBC’s Dan Mangan @danpostman
[5] – 2007 – Written by James Hirby | Fact checked by The Law Dictionary staff


I show JzG what a “FACT” is: Burzynski: FAQ (Frequently Asked Questions): Clinical Trial Results:

Burzynski: FAQ (Frequently Asked Questions): Clinical Trial Results:
Who is JzG and why should you care?

JzG claims there is a “misleading factoid”

JzG does NOT seem to comprehend that the reason something is titled as a “FACT,” is because it is NOT misleading

JzG does NOT seem to understand that indicating that a “FACT” is misleading, is oxymoronic

It is a “FACT” that:

“Trial results are not always publicly available, even after a clinical trial ends”

(Source: U.S. National Library of Medicine, National Institutes of Health)

An individual with the same initials (JzG also known as JzG|Guy) is one of the “gatekeepers” of the “Burzynski Clinic” Wikipedia page, as I documented HERE:

guychapman (Guy Chapman) Critiquing “The Skeptic” Burzynski Critics: A Film Producer, A Cancer Doctor, And Their Critics (page 9)
(Guy Chapman, @SceptiGuy, @vGuyUK, guychapman)
Wikipedia apologist Guy Chapman’s United Kingdom “blahg:”
Wikipedia, what’s your motivation?:
JzG are you related to Guy Chapman?

I consider him to be a coward

Wikipedia’s “Neutral” policy history clearly indicates:

“The relative prominence of each viewpoint among Wikipedia editors or the general public is not relevant and should not be considered, …”

[[WP:NPOV]] “History of NPOV:” (Content # 6, Note 3)

(Wikipedia: Neutral Point Of View)

This is also a “factoid,” and the JzG|Guy “gatekeeper” on Wikipedia gave it the same amount of respect JzG gives the U.S. National Library of Medicine, National Institutes of Health

Which leads one to wonder if they are twins, considering that one had the testicular fortitude to post a comment, and the other is a coward and trumpets U.K. views

One JzG|Guy commented on Wikipedia:

> “We are told that 2013 will be a big year, but apparently his plan is to

> release another bullshit movie not to publish useful research.” JzG|Guy
> User:JzG/help|Help! 21:52, 24 December 2013
to view this change

> “There is unlikely to be any dispassionate debate over ANPs while Burzynski
> continues with his unethical practices.” JzG|Guy User:JzG/help|Help!
> 12:43, 26 December 2012
> Continues with his unethical practices.? Yet TMB/SOAH had their
> case dismissed? Is WP judge, jury, & executioner?

to view this change.

I could really care less what JzG|Guy’s “opinion” is, since:

Wikipedia’s “Neutral” policy history clearly indicates:

“The relative prominence of each viewpoint among Wikipedia editors or the general public is not relevant and should not be considered, …”

[[WP:NPOV]] “History of NPOV:” (Content # 6, Note 3)

(Wikipedia: Neutral Point Of View)

As the old military saying goes:

If I wanted your opinion … (Wikipedia) … I’d beat it out of you

In this blog post reply, Wikipedia shill “JzG” presents a single myopic misleading meme for a number of reasons in respect of Stanislaw Burzynski

JzG posits:

“Most obvious of these is that of the 61 trials registered by Burzynski over nearly two decades, only one has even been completed.”

WHAT “completed” trial is JzG referring to?

Good question, since I have yet to find one of “The Skeptics” who could adequately describe what Protocol, start date, and completion date apply to this “one” trial they keep mentioning

Antineoplaston Therapy in Treating Patients With Stage IV Melanoma
Phase II
Age: 18 and over
Protocol IDs: CDR0000066552, BC-ME-2, NCT00003509

11/25/1997 – FORM 10-SB

Click to access 0000950110-97-001598.pdf

8 40
7/26/96 – Revised
10/4/96 – Revised
4/14/97 – Revised

11/1/1999 – First received

5/23/2009 – Last updated

5/2009 – Last verified
Burzynski Clinical Trials (The SEC filings):
5/1/2012 Certain prospective protocols which have reached a Milestone:
Antineoplaston Therapy in Treating Patients With Stage IV Melanomau
Melanoma (Skin)
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase II / Phase 2
Age 18 and over
Protocol IDs
BC-ME-2, NCT00003509
2009_05_26 Study Changes Recruitment status, Recruitment, Misc.
1 clinical_study study_id
is_fda_regulated Yes
is_section_801 Yes
delayed_posting No
resp_party name_title Stanislaw R. Burzynski
name_title organization Burzynski Clinic
organization resp_party

Fm: Active, not recruiting

status date
Fm: 2008-04
To: 2009-05

Fm: 2008-01
To: 2005-02

Fm: 2008-07-23
To: 2009-05-23

2009-05-23 (5/23/2009)

To put this in perspective, the below study done in 2006, was NOT published until about 7 years later, in 2013

2/13/2013 – 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

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

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

Division of Endocrinology, Mayo Clinic

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

Supportive Care in Cancer
February 2013


JzG continues:

“Then there’s the fact that unpublished trials are not generally acceptable when applying for approval for a drug, or when promoting the drug (in this case it’s hardly relevant as he appears to have no intention of applying for approval; the trials seem to be used as an end-run around restrictions on his use of unapproved drugs).”

JzG ignores:

Burzynski: What happens when a clinical trial is over?:

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

Cancer Clinical Trials

15. What happens when a clinical trial is over?

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

” … WHETHER OR NOT the results are published in a peer-reviewed scientific journal … “
This makes it clear that clinical trial results “are OFTEN” published, but sometimes they are “NOT” published “in a peer-reviewed scientific journal”

Burzynski: Declaration of Helsinki:
The Declaration of Helsinki does NOT indicate WHEN final (completed) results of human clinical trials MUST be published

Burzynski: The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective:
Nowhere does it indicate that final (completed) human clinical trial results MUST be published in a peer-reviewed scientific medical journal
JzG comments:

“Why does the medical and scientific community not accept Burzynski’s claims to cure cancer? Because he has failed to publish credible evidence. The few papers he has published are neither compelling nor generally useful in evaluating his claims.”

JzG where is / are YOUR in-depth review(s) of the 2003-2007 phase II clinical trials preliminary reports?

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

Musings on the intersection of Articles, Bias, and Censorship

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

4/19/2013 @ 9:43PM

A Film Producer, A Cancer Doctor, And Their Critics

FW 1 week ago

“Erm, what conflict of interest?”

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

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

Seriously, get a grip.

FW 1 week ago

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

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

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

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

FW, what do you call THIS ?

Burzynski Clinical Trials (The SEC filings)
“As I said earlier, the Phase 3 trial has been registered since 2010 and Burzynski shows no inclination to start it, having NOT A SINGLE PATIENT RECRUITED.”

FW, as I said earlier, did you pay attention to this?

Burzynski: Not every cancer clinical trial taking place in the United States is listed on our NCI clinical trials database
Burzynski’s Securities and Exchange Commission (SEC) Form 10-Q for the quarterly period ended 5/31/2010 states:

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

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

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

ResearchPoint is currently conducting feasibility assessment

ResearchPoint has secured interest and commitment from number of sites selected

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

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

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

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

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

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

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

FW 1 week ago

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

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

“Why continue?”

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

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

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

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

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

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

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

Which also happens to Burzynski

rjblaskiewicz 1 week ago

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

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

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

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

My Critique of Bob Blaskiewicz (Colorado Public Television – PBS CPT12)
Critiquing Bob Blaskiewicz (#Burzynski Cancer is Serious Business, Part II)
Boris Ogon 1 week ago

(citing Astroturfwatch’s comments):

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

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

(Boris Ogon)

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

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

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

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

“Find just one, any single cure for this tumor type and you can’t, outside of Antineoplastons FDA sanctioned clinical trials:”

Click to access 1252.pdf

(Boris Ogon)

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

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

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

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

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

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

“Six patients had not received chemotherapy or radiation.”

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

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

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

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

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

“End result?”

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

“Color me unimpressed.”

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

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

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

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

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

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

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

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

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

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

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

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

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

The “chart on page 172 (page 8 of PDF):”

Click to access 1252.pdf

refers to:

2006 Adis – Pediatr Drugs 2006; 8 (3)

pg 172

Treatments for Astrocytic Tumors

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

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

pg 177

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

This is the 2004 publication, NOT 2003

Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma : a preliminary report.
Drugs R D. 2004;5(6):315-26

pg 172

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

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

pg 177

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

Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with antineoplastons A10 and AS2-1.
Integr Cancer Ther. 2005 Jun;4(2):168-77

pg 173

1.4.3 Targeted Therapy

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

pg 176

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

Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma: a preliminary report.
Drugs R D. 2003;4(2):91-101

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

Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma.

Integr Cancer Ther. 2006 Mar;5(1):40-7

30 evaluable patients with recurrent and progressive DBSG

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

27% – CR – Complete Response
20% – PR – Partial Response
23% – SD – Stable Disease
30% – PD – Progressive Disease

pg 175

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

pg 173

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

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

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

“The results are compiled in table II.”

pg 174

2.3. Targeted Therapy

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

1652 adults
335 children

pg 178

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

pg 174

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

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

pg 169

1.1.4. Targeted Therapy

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

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

LGA = Low-Grade Astrocytomas
Table I. Selected chemotherapy regimens for the treatment of low- grade astrocytoma in children

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

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

pg 176

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

“One further has to take into account the fact that Scamley has been known to employ idiosyncratic definitions, such as classifying tumor *growth* as “stable disease” for “less than 50% reduction in size but no more than 50% increase in size of the tumor mass, lasting for at least twelve weeks.””

Mr. Ogon, did you read THIS ?

5/2007 – Guidance for Industry – Food and Drug Administration
Guidance for Industry

Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics

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

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

May 2007 Clinical/Medical

“STABLE DISEASE should not be a component of ORR

STABLE DISEASE can reflect the natural history of disease”

(Pg. 10 of 22 = actual pg. 7 of PDF)
“…STABLE DISEASE can be more accurately assessed by TTP or PFS analysis (see below)”
(Pg. 11 of 22 = actual pg. 8 of PDF)

Time to Progression and Progression-Free Survival

TTP – Time to Progression

PFS – Progression-Free Survival

Time to Progression and Progression-Free Survival

TTP and PFS have served as primary endpoints for drug approval

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

Click to access ucm071590.pdf

And in addition, the below 2005 non-Burzynski study also uses “STABLE DISEASE:”

Role of temozolomide after radiotherapy for newly diagnosed diffuse brainstem glioma in children
Results of a multiinstitutional study (SJHG-98)
St. Jude Children’s Research Hospital (Memphis, TN)
29 (88)
Texas Children’s Medical Center (Houston, TX)
2 (6)
Children’s Medical Center (Dallas, TX)
2 (6)
Cancer. 2005 Jan 1;103(1):133-9
Cancer 103, 133-139
Cancer Volume 103, Issue 1, pages 133–139, 1 January 2005
DOI: 10.1002/cncr.20741
Article first published online: 24 NOV 2004
American Cancer Society

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

Mr. Ogon, what was that about

“fact-checking” ?

Lynne 1 week ago

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

“Burzynski is not the only one.”

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

“Just one example:”


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

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

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

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

“There are a lot more examples out there.”

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

Lynne, did you look HERE ?

Burzynski Clinical Trials (The SEC filings):
“He could post it tomorrow; it doesn’t have to be in a peer reviewed journal.”

Lynne, at least you’re right about that:

Burzynski: What happens when a clinical trial is over?
“Instead, we are asked to just believe him because he’s such a nice guy who cares so much.”

Lynne, that’s one way to do it:

Burzynski: Declaration of Helsinki
“To complete the equation, you have to know the denominator:”

Lynne, that’s another option:

Burzynski: FAQ: Clinical Trial Results
“how many didn’t make it.”

Lynne, you could ask that too:

Antineoplastons: Has the FDA kept its promise to the American people ?
“Conventional medicine is transparent and reports failures.”

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

Burzynski: The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective:
“Burzynski doesn’t.”

Lynne, if you say so:

Burzynski – The Antineoplaston Randomized Japan Phase II Clinical Trial Study:
“Just another reason the body of scientists don’t find him credible.”

Lynne, like THESE ?

Burzynski referenced by other Cancer researchers:
Boris Ogon

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


Not so much

Waiting for the 10,000

4/19/2013 @ 9:43PM

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