Pete Cohen talks to Steve and Mary Jo Siegel

This is our the best and the dearest, uh, patient who came to our clinic 20
——————————————————————
2
——————————————————————
2 years ago
——————————————————————
22 years ago
——————————————————————
and she was in the, she came with Hodgkin lymphoma, and a stage 4, and she didn’t have good, uh, prognosis
How long, did they tell you
——————————————————————
They told me that I was gonna die, of non-Hodgkins lymphoma
That I had a fatal disease
They would treat me for awhile with, uh, chemotherapy and radiation, um, a bone marrow transplant, and, um, we, they, we would see what would happen, but no cure
Not a cure at all
——————————————————————
So
——————————————————————
That was 22 years ago
Um, I thank God everyday that I found Dr. Burzynski’s clinic, and Dr. Burzynski and his staff
Um, I was on his treatment for, um, 3 months when this huge tumor on the side of my neck started to reduce and finally disappeared
——————————————————————
So we adopted her as our, uh, family
——————————————————————
(laughs)
——————————————————————
Yeah
——————————————————————
and now, she is our family member, and many others
——————————————————————
So tell me, uh, how did you find out about Dr. Burzynski?
——————————————————————
I was in a cancer support group, and, uh, one of the ladies in there said, you know, you have non-Hodgkins lymphoma
There’s a doctor in Houston whose been treating it with very good results
You should go and check it out
Which I went back home to my husband and said: “There’s Dr. Burzynski in Houston, Texas, and he’s having good results,” and, ah, Steve said: “You know, I’ve heard of this doctor
You know, I wrote his name down”
He’d heard about him
Wrote his name down for future use, and I think about, uh, the next couple of days we were in Houston, and we got to the clinic and I just felt I was in the right place
Everybody there
It was
The feeling was so different than being at a UCLA or a USC or Dana Farber
It was just
I knew immediately I was in the right place, and I met Dr. Burzynski
Well first of all Dr. Barbara came out and hugged me, and, uh, it was, it was so wonderful and I’ll never forget the feeling of, of, uh, my first walk into the Burzynski Clinic
——————————————————————
So tell me, what did, uh, any, did, did you have an oncologist at home and tell them that you were coming here ?
——————————————————————
Yeah, we did
Um, uh, I had an oncologist at UCLA who was a lymphoma specialist, and he was the one that told me I would die of the disease
Um, when we told him that we were going to see Dr. Burzynski, he wasn’t, uh, overjoyed, to say the least, and he told us very negative things and, uh, but I thought, he wasn’t offering me anything, and, uh, when I did get to the Burzynski Clinic, Dr. Burzynski said to me: “I think I can help you,” he said
He didn’t
He didn’t tell me, he was going to cure me
He didn’t
He just said: “I think I can help you,” and, it was non-toxic, and the, um, conventional medicine was offering me high-dose chemotherapy, radiation, and in fact, in mu, as much radiation as people who were, uh, within one mile of ground zero at Hiroshima, and, and they were going to bring me as close to death as possible, and then, rescue me
Uh, and then Dr. Burzynski was going to do this and actually have, where actually I would have hope of a cure, non-toxically
My hair never fell out
I felt well
Um, I lead my normal life
I drove my kids to school
I cleaned the house
Whatever
You know
It was
It’s a wonderful treatment
——————————————————————
So, at what point did you realize, I’m free of cancer ?
Do you remember that point of ?
——————————————————————
Uh, well I remember the point
I remember it very well
Um, the, it
It’s so big
Um, I had, uh, several CAT scans
I had 2 CAT scans in a row
The first one that showed no cancer at all, and, um, I had them done at UCLA, and, um, and then I had a second one, 3 months later, and that one was, was absolutely clear
So, um, it was, it was an amazing feeling, and actually 48 hours was following me, because it was, it was a really a big story, um, you know
Cancer throughout my body
No, no cancer at all and, and my medical records show, um, you look at my X-rays, my CAT scans, from starting Dr. Burzynski’s treatment, um, to approximately 9 months later
Reduction, reduction, reduction, until there was no cancer
——————————————————————
So what did, what did your oncologist say ?
Did you, did you go back to your oncologist and say: “You said I was gonna die”
——————————————————————
Uh, yes, we did that
——————————————————————
And what did he say ?
——————————————————————
And, and actually people would call him and a, people who were interested in Dr. Burzynski, and he would say: “Oh, she’s a spontaneous remission”
He would never accept the fact that I was treated, and cured by Dr. Burzynski, but my medical records prove it, and of, you know I, There are so many patients like me
I’m not the only one
So
——————————————————————
So ok, tell me
Let me ask you a couple more questions
——————————————————————
Mhmm
——————————————————————
What sort of a person do you think Dr. Burzynski is?
——————————————————————
Well aside from being the most wonderful, gentle, sensitive, caring doctor, and you don’t find many of those
I went to many doctors, while, while we were trying to find the answer
Many, and Dr. Burzynski is so above them
He, because he really makes you feel like a person, and that he cares, and, he’s also a genius
He, I know that he speaks about 8 languages
He’s an expert on the Bible
He, he just knows so much about everything
Um, I love to be in the room with him
He’s a very special man
——————————————————————
So, you recovered, and then, ’cause you, when did you set up the patient support group, and why did you do that ?
——————————————————————
Uh, actually my husband and I did that together, and it was during, um, the trials, uh, the Texas State Board started, in fact, I became a patient, and 2 months later, ah, he was brought to a hearing in front of the Texas State Medical Board, and so Steve and I, um, organized the patients to, um, be at that hearing to support Dr. B, ’cause he’d been going through this long before I became a patient, but, um, we wanted to show support, because I was already starting to fe, I was feeling better already
I was already seeing some reduction, and now my, the medicine was in jeopardy
I, It could be taken away from me at any time
So we decided to organize the patients and to show support, and all the patients wanted to help, a, uh, obviously
So, um, we’d go to every hearing, every, uh, the trial, we were there every day, um, and we would, patients would march in front of the court building, um,
It was, it was really a sight
An unbelievable sight
——————————————————————
And why do you think that he was treated the way that he was treated ?
Why do you think they wanted to take him down ?
——————————————————————
I think it’s because
There’s many reasons
I think the main reason is because what Dr. Burzynski does is making what all other conventional doctors are doing wrong, because chemotherapy is not the answer
Chemotherapy makes people sick, and, uh, most of the time it does not cure people
Um, all that poison and radiation
There’s gotta be a better way, and there is a better way
Dr. Burzynski has found it
I was sick
I had cancer 22 years ago
Um, my hair never fell out, and, uh, it was a treatment that I was grateful to be on every day
——————————————————————
So how many patients have you come in contact with that Dr. Burzynski
——————————————————————
Hundreds
Hundreds, and as you say by my patient group web-site
Um, I think I have about 90 stories on there now, and there are many more, because, um, I haven’t been able to get in touch with everybody, but over the years, uh, people give me their stories
Sometimes people will call me, um, but we, we are a patient group because we, we’ve all been helped or cured by Dr. Burzynski, and we, we want everybody to have access to this treatment

Steve actually had the chance to ask one of, uh, one of the prosecutors, um, at the trial, that exact question: “What would you do,” and he was prosecuting Dr. Burzynski, and he actually said: “I’d be first in line”
So, once you know the whole story, and you know the science, and you, especially if you do the research, um, you, you can come to the truth, and the truth is, Dr. Burzynski, has cured cancer
He cured me
I’ve been in remission for, in remission, for, uh, 22 years, and that’s a cure, and, uh, he could help so many, many, many more people
The, he has breast cancer patients now that are, that are doing so well
He has many
I just talked to an ovarian cancer patient
He has, um, all, all different types of cancers
What he needs is funding from our government
Um, all other doctors and, and, um, institutions, they get ah, mu, get so much money from the government
Dr. Burzynski doesn’t get one penny
If we could just think
If, d, if the government would just fund Dr. Burzynski, he could have a cure for all cancers
I believe that with all my heart, and somehow, some day this has to happen
——————————————————————
The Sceptics (10:37)
——————————————————————
Yeah, just tell me what this whole kind of skeptic movement
You do any research on Dr. Burzynski there’s a few things
——————————————————————
Yes
——————————————————————
that always come up
This guy Saul
——————————————————————
Saul Green
——————————————————————
Yeah
——————————————————————
Mmm
——————————————————————
and some other stuff
——————————————————————
Yeah
——————————————————————
So just tell me
What’s that all about and where did that all come from ?
——————————————————————
It stems from, uh, a lawsuit that was filed against, uh, Dr. Burzynski
Actually it was, uh, an insurance company, that didn’t wanna pay for, uh, for the treatment
A particular patient had been treated here in Texas, uh, was put into remission
Was successfully treated and then it turns out the insurance company did not wanna pay for it, so they brought in these people
These quote unquote experts
Cancer experts of, you know, rather dubious backgrounds
This is all that they do, is they look for ways to demean people
They look for ways to blacken their reputation
They ultimately became a group known as Quack watch, and these were brought in as the expert witnesses to say that this is not an approved treatment, albeit, was not true
They said the treatment didn’t work and clearly it did, and, uh, they have since gotten funding from insurance companies, from the government, private funding, and they go around to debunk things that are against mainstream, um, medicine, and, uh, their, their support comes from the insurance company and from the pharmaceutical companies who benefit from, from their work, and, uh, it expanded
Expanded all over the world to, uh, they’re in the United States, they’re in the U.K., they’re in Australia, and, uh, they have a very big presence
When the internet came into being they, you know, they went viral with this kind of stuff
So when you type in Burzynski, uh, a lot of the negative comes up first
So that’s the first thing you see is all this negative stuff, and it’s all hearsay
None of it has any basis in fact
It’s all lies
Um, you know, he, Dr. Burzynski never did anything illegal ever, and it was all based on, on very questionable legal grounds that he was ever sued, that he was, that any case was ever brought against him by the FDA or the Texas Medical Board, and all of those cases failed
They never held up to scrutiny
They all failed, and here Dr. Burzynski is today, and he’s thriving, and people come here from all over the world to be treated
Many are cured of their cancers, and, uh, all of these people in the Quack watch are gone
Uh, Saul Green has passed away
Uh, I don’t wish him ill, but I’m glad he’s not here, thank you, and all of these other people are gone and they’re not thriving, and they’re just like, you know, they’re like bacteria or like fungus under rocks, and when you shine a light on them, they can’t hold up to the scrutiny
The real light is here
The real truth is here in Houston at the Burzynski Clinic
——————————————————————
Thoughts on Dr. Burzynski (13:46)
——————————————————————
What do you think of Dr. Burzynski, yourself ?
——————————————————————
I, I, I think Mary Jo’s pretty much summed it up
Uh, I, am of course
It, it, it’s not an unbiased opinion
It can’t be
He’s the man that saved my wife
Uh, she was cast off, um, as, as, as an incurable
She was told time and time again, not just by her on, oncologist at UCLA, Dr. Peter Rosen, but we went all over the country
We went to USC in, University of Southern California, UCLA, Stanford Medical, Dana-Farber; which is associated with Harvard, uh, in, uh, Boston, and everywhere we went, she was told: “There’s no hope”
“You’re gonna die”
“It’s just a matter of time”
“We have to see how long, how long it’s gonna take”
Um, against my better wishes, we came to the Burzynski Clinic, and she said: “I’m starting today,” and I said: “Don’t you think we should go back and discuss with Dr. Rosen at UCLA ?
She said: “No, they have nothing to offer me”
She was that brave, and we started that day, and we’ve never looked, we’ve never looked back
So to ask me about what I think about Dr. Burzynski, when my wife was told she was gonna die, and I was already making plans for how am I going to take care of my children without Mary Jo; my life partner, and he saved her life, I’m not gonna give you unbiased
——————————————————————
Mhmm
——————————————————————
an unbiased opinion of how I feel about the man
There’s probably nobody, that I have greater love and greater respect for, uh, in, in the whole world, and, uh, to add about how, how smart, how intelligent this man is, ah, expert on, on history as Barbara was saying
Expert on religion
He’s an expert on mushrooms
He knows more about mushrooms than any 10 mushroom experts in the world
Bees
He knows about bees
Who cares about bees, but he knows everything, because bees happen to be a rich production source of antineoplastons
Who knew ?
Dr. Burzynski knew, and that’s why we need to listen to him
We as a society
The world needs to listen to this man
——————————————————————
Conventional Cancer Treatment and The FDA (16:05)
——————————————————————
When you put some critical thought, critical analysis, you find that chemotherapy initially works
What it is, it’s a good, the first time around it’s a good tumor shrinking, they’re good tumor shrinking agents, but over the long run they create so many problems that eventually, the tumor becomes, the cells become resistant and the tumor takes over, or, if it is successful in shrinking the tumor to, to a, a size where the patient can survive, what happens after that is there’s a secondary cancer that’s created by the chemotherapy, with very few exceptions
Testicular cancer is one exception where it works
Some childhood leukemia’s they’ve had some great success with chemotherapy, but by in large it’s a failed modality, and the side effects are so bad as, as to be called horrific, uh, is how I would describe them from what I’ve seen in, in my family and in my friends, and my associates that’ve had to undergo it
So why do we allow that, when something like antineoplastons and Burzynski’s treatment, totally non-toxic, working with the body, allowing you to lead a normal life, and on it statistically for the number of people that have been treated, uh, compared to the number of people that have walked out of here in remission, or cured after 5 years; whatever definition you wanna use, we don’t allow that
We look at that as, uh, conventional medicine looks at like that as, looks at that as some sort of quackery
This is, this is, uh, critical thinking and science turned on its head, and it doesn’t make sense, and it goes back to what I was saying before
Why it doesn’t make sense, because there’s entrenched financial interests, and there’s a paradigm that says we do for cancer, we do chemotherapy, we do radiation, we do surgery, and that’s it
Anything else is not acceptable, because it goes against the paradigm

In the bureaucracy we know as the FDA
We’ve been fighting them for so long and they’ve been described as “The B Team”
“The B Team” is,that they be here when you come in and you start complaining, your problem starts, they be here, and when you decide to quit complaining because you’ve beat your head against the wall for so many years, they still be here (laugh)
So it’s “The B Team”
They’re bureaucrats
This is what they do
There, they have a certain set of tasks
Certain things that they’re tasked with
Protection of the food and drug supply of the United States, whatever that means
Whatever they deem it to mean
Whatever they decide it means
That’s what they’re gonna do, and it’s pretty hard to fight that
It’s pretty hard, unless you have a political, unless you have a, a, a, a political, ah, constituency, and you can put a lot of pressure on them
——————————————————————
So
——————————————————————
and that’s the only way
——————————————————————
So what’s the answer ?
What will, uh
How will Dr. Burzynski prevail ?
——————————————————————
Ultimately, in, in my, in my, in my view, the real tragedy is, is that he’s not going to prevail here in the United States
It’s going to be extremely difficult
It’s an uphill battle that, knowing Dr. Burzynski, he’s gonna keep fighting it, uh, and, and he’ll keep fighting that battle, but the real opportunity for him is to, uh, move this product and license it overseas, and, uh, other countries are interested
Other countries are more open, uh, to new modalities
They’re not entrenched, uh, and don’t have the financial, uh, interests, the, that are, the entrenched financial interests like we do here, like chemotherapy and, and, uh, radiation therapy, and I think that’s where ultimately we as Americans, as sad as it is, are going to have to go overseas to be treated and to get this medication

The FDA is so capricious in their decision-making, and in their exception granting, uh, that if Pat had AIDS, and this was anti-AIDS medication; proven or not or only with limited, uh, proven efficaciousness, uh, and proven limited proof that it was somewhat non-toxic, she would be able to get approval like that
The FDA has taken a drug approval process that generally takes anywhere from 10 to 15 years, and where there is political, successful political pressure applied, they have reduced that down to some cases 4 to 8 months as in the case of the anti-HIV drugs, and that’s because there is a very strong, very powerful political lobby in Washington, and throughout the country, and they have been able to apply pressure at key points in, uh, Congress
Congress puts that pressure on the FDA, says: “C’mon let’s get the ball forward
These are voting people
We have millions of people in this country with HIV who are compacted together and make a viable political force
Let’s move forward”
In the case of multiple-myeloma
In the case of these cancers or these people that wanna be treated, who have failed all conventional therapy, and wanna be treated by Dr. Burzynski with something that we know works
Something that is, is non-toxic, they, they don’t have
We’re not a viable political force
We’re not important to the Washington bureaucrats, to the Washington lawmakers
So nothing gets done, and these exceptions for the use of antineoplastons are not granted, and that’s, that’s the sad truth
======================================
Steve and Mary Jo Siegel
January 2012
22:01
11/9/2012
——————————————————————

======================================

Advertisement

Turkey Lurkey Thanksgiving Title

Traditionally, Thanksgiving is best known as the Holiday that the Detroit Lions get the “stuffing” knocked out of them

However, this year, it’s time to tender the tainted twisted trophy of Thanksgiving Turkey-Lurkey to Detroit’s toasted triumvirate treat of two-faced twerk-salad troll turpitude, and I have the temerity to tinker and tamper until I pay tribute with therapeutic levels of Thoreauness in response to GorskGeek’s misinformation, disinformation, and MisDisInformation (Missed ‘Dis Information)

Wednesday, 12/21/2005, Indianapolis, Indiana-based Eli Lilly and Company was treated to truthification, in connection with their illegal promotion (misbranding) of pharmaceutical drug EVISTA; (FDA approved for prevention and treatment of osteoporosis in post-menopausal women), in the:

a. prevention in risk of breast cancer

b. reduction in risk of breast cancer

Alleged in information, promoted drug as effective for reducing risk of breast cancer EVEN AFTER PROPOSED LABELING FOR THIS USE SPECIFICALLY REJECTED by FDA [1]

GorskGeek, being the breast cancer oncology specialist he claims to be, and so concerned about breast cancer patients that he is that “guy” who speaks out passionately about issues like the 10-year American Cancer Society Cancer Facts & Figures, “Estimated Breast Cancer Deaths for Women”, which reflect that in 2002, 39,600 (15%) women were estimated to die from breast cancer, and this year, 2013, the estimate is 39,620 (14%), which is 20 women MORE than 10-years ago, and who rails tirelessly about the ACS’s “Estimated New Breast Cancer cases in Women”, which 10-years ago was 203,500 (31%) in 2002, and now, in 2013 is 232,340 (29%), which is ONLY
28,840 MORE
than 10-years ago [2]

Now THAT’s progress !

GorskGeek, of course, must accomplish all this under his breath

But I’m sure you’re wondering, dear reader, what was GorskGeek’s outraged blog about this American pharmaceutical manufacturer coughing up $36 MILLION ?

Well, let me tell you … just as soon as I find it

Wait for it

Wait for it

Wait for it

GorskGeek was unable to bring himself to blog about Evista until exactly one year later, on 12/21/2006, and even then, he was “mum’s the word” about the breast cancer claims [3]

Perhaps GorskGeek just “knew” that eventually Evista would finally be approved by the FDA for Eli Lilly’s preventing or reducing risk of breast cancer claims on 9/13/2007, and who were those paper-pushing FDA apparatchiks to prevent Lilly from implementing their “Internal business plan” ? [4-9]

GorskGeek wouldn’t want to damage his slim and non-existent chance of getting some Eli Lilly money for research, by blogging anything that might in any way be possibly construed as him saying anything negatory about the BIG Pharma teat he longs to suck off of

After all, Bob ‘n’ Weave Blaskiewicz (who sees every molehill as a mountain), did say about GorskGeek, 9/28/2013 [10]:
——————————————————————
1:58:04
——————————————————————
“But he is a, the thing is, the thing is, you thing you have to understand is Gorski, Gorski is a genuine expert, in matters re re regarding on oncology studies

“I mean, he has a”

“He, He’s able to convince people, he’s able to convince people, on the strength of his record, to give him money to carry out research

“People who know what they’re talking about”

“To give him money to carry out his research”

“Right ?”
——————————————————————
1:59:00
——————————————————————
Yeah, right

Bobby 🙂

GorskGeek is hoping for a Happy Thanksgiving Golden Parachute; which is where he helps whistleblow about illegal BIG Pharma activity regarding some drug(s), which leaves him as the beneficiary of some funds like Mr. H. Dean Steinke, former Merck employee and his $68,190,000 MILLION from the federal government and states share of settlement amounts:
——————————————————————
$44,690,000 MILLIONMr. H. Dean Steinke, former Merck employee from federal share of settlement amount (1997 – 2001)
——————————————————————
$23.5 MILLIONMr. H. Dean Steinke, former Merck employee from the states share of settlement amount (1997 – 2001)
——————————————————————
Next, GorskGeek goes off on his fave autism prescription antipsychotic drug Risperdal, and the 11/4/2013, Monday, allegations concerning Global health care giant Johnson & Johnson (J&J) and its subsidiaries, $2.2 BILLION + fine regarding J&J Subsidiary Janssen (1999 – 2005) actions [11]
======================================
REFERENCES:
======================================
[1] – 12/21/2005
——————————————————————
EVISTA (FDA approved for prevention and treatment of osteoporosis in post-menopausal women)
——————————————————————
Eli Lilly and Company, Indianapolis, Indiana-based company
——————————————————————
12/21/2005, Wednesday
——————————————————————
$36 MILLION
——————————————————————
In connection with illegal promotion of pharmaceutical drug
——————————————————————
Pleading guilty to criminal count of violating Food, Drug, and Cosmetic Act by misbranding drug
——————————————————————
In addition to criminal plea
agreed to settle civil Food, Drug, and Cosmetic Act liabilities by entering into consent decree of permanent injunction
——————————————————————
Charged in criminal information filed with violation of Food, Drug, and Cosmetic Act, following investigation by Food and Drug Administration’s (FDA) Office of Criminal Investigations
——————————————————————
Plea agreement signed by Lilly and United States

Complaint for permanent injunction

Consent decree of permanent injunction signed by company and United States
——————————————————————
Information alleges 1st year’s sales of drug in U.S. were disappointing compared to original forecast
——————————————————————
According to information
10/1998 – company reduced forecast of drug’s 1st year’s sales in U.S. from $401 million to $120 million
——————————————————————
Internal business plan noted:

“Disappointing year versus original forecast.”
——————————————————————
Information alleges in order to expand sales of drug, Lilly sought to broaden market for drug by promoting it for unapproved uses
——————————————————————
Information alleges strategic marketing plans and promotion touted drug as effective in preventing and reducing risk of diseases for which drug’s labeling lacked adequate directions for use
——————————————————————
According to information: Evista
1. brand team
2. sales representatives
promoted drug for:
a. prevention in risk of breast cancer
b. reduction in risk of breast cancer
c. reduction in risk of cardiovascular disease
——————————————————————
Under provisions of Food, Drug, and Cosmetic Act, drug misbranded when labeling didn’t bear adequate directions for each of intended uses
——————————————————————
Alleged in information, promoted drug as effective for reducing risk of breast cancer even after proposed labeling for this use specifically rejected by FDA
——————————————————————
Information alleges executed illegal conduct using number of tactics, including:

1. One-on-one sales pitches by sales representatives promoting drug to physicians about off-label uses of drug

2. Sales representatives trained to prompt or bait questions by doctors in order to promote drug for unapproved uses

3. Encouraging sales representatives promoting drug to send unsolicited medical letters to promote drug for unapproved use to doctors on their sales routes

4. Organizing “market research summit’ during which drug was discussed with physicians for unapproved uses, including reducing risk of breast cancer

5.
a. Creating
b. distributing
to sales representatives “Evista Best Practices” videotape, in which sales representative states “Evista truly is the best drug for the prevention of all these diseases” referring to:

1). osteoporosis
2). breast cancer
3). cardiovascular disease
——————————————————————
Complaint for permanent injunction alleges executed illegal conduct using number of tactics, including:

1. Training sales representatives to promote drug for prevention and reduction in risk of breast cancer by use of medical reprint in way that highlighted key results of drug and thereby promoted drug to doctors for unapproved use

2. Some sales representatives were instructed to hide disclosure page of reprint which noted:

a. “All of the authors were either employees or paid consultants of Eli Lilly at the time this article was written,”

b. “The prescribing information provides that “The effectiveness of [Evista] in reducing the risk of breast cancer has not yet been established.””

3. Organizing “consultant meetings” for physicians who prescribed drug during which unapproved uses of drug discussed

4. Calculating incremental new prescriptions for doctors who attended Evista advisory board meetings in 1998

5. advisory board meetings included discussion of unapproved uses for drug

6. By measuring and analyzing incremental new prescriptions for doctors who attended advisory board meetings, Lilly was using this intervention as tool to promote and sell drug
——————————————————————
In addition to agreeing to plead guilty to criminal information and plea agreement signed by Lilly, settlement with United States includes following components:

(a) agreed to settle civil Food, Drug, and Cosmetic Act liabilities by entering into consent decree of permanent injunction

(1). As part of consent decree, agreed to comply with terms of permanent injunction, which will require company to implement effective training and supervision of marketing and sales staff for drug, and ensure any future off-label marketing conduct is detected and corrected

(2). agreed to be permanently enjoined from directly or indirectly promoting drug for use in:

a. preventing or reducing risk of breast cancer

b. reducing risk of cardiovascular disease

c. or for any other unapproved use in manner that violates Food, Drug, and Cosmetic Act unless and until FDA approves drug for additional use or uses
——————————————————————
(b) as part of consent decree, agreed to hire and utilize independent organization to conduct reviews to assist Lilly in assessing and evaluating Lilly’s

1. systems
2. processes
3. policies
4. procedures
relating to promotion of drug and company’s compliance with consent decree
——————————————————————
FDA made following announcement to postmenopausal women who have taken drug for prevention or treatment of osteoporosis:
——————————————————————
“No postmenopausal woman who has taken Evista for the prevention or treatment of osteoporosis is affected by this action, as this matter today relates only to unapproved uses of Evista.”
——————————————————————
Defendant agreed to plead guilty to charge in information
——————————————————————
Defendant agreed to resolve complaint for permanent injunction by agreeing to consent decree of permanent injunction
——————————————————————
http://www.justice.gov/opa/pr/2005/December/05_civ_685.html
======================================
[2] – 11/13/2013 – The War on Cancer (I don’t think it means, what you think it says it means) #Winning?:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/13/httpcancer-orgacsgroupscontentepidemiologysurveilancedocumentsdocumentacspc-036845-pdf/
======================================
[3] – 12/21/2006 – On the messiness of evidence-based medicine
——————————————————————
http://scienceblogs.com/insolence/2006/12/21/the-messiness-of-evidencebased-medicine/
======================================
[4] – 9/13/2007FDA Approval for Raloxifene Hydrochloride (Brand name(s): Evista®): Approved for breast cancer risk reduction:
——————————————————————
http://www.cancer.gov/cancertopics/druginfo/fda-raloxifene-hydrochloride
======================================
[5] – 9/14/2007FDA Approves New Uses for Evista: Drug Reduces Risk of Invasive Breast Cancer in Postmenopausal Women:
——————————————————————
http://www.fda.gov/newsevents/newsroom/pressannouncements/2007/ucm108981.htm
======================================
[6] – 9/17/2007Evista Approved for Reducing Breast Cancer Risk:
——————————————————————
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048474.htm
======================================
[7] – 2007
——————————————————————

Click to access 020815s018lbl.pdf

======================================
[8]
——————————————————————

Click to access ucm088593.pdf

======================================
[9] – 2007
——————————————————————

Click to access 022042lbl.pdf

======================================
[10] – 10/18/2013 – Deconstructing Dr. David H. (Orac) Gorski – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/10/18/deconstructing-dr-david-h-orac-gorski-september-28-2013-the-skeptics-burzynski-discussion-by-bob-blaskiewicz-21951/
======================================
[11] – 11/4/2013
——————————————————————
http://www.justice.gov/opa/pr/2013/November/13-ag-1170.html
======================================

Critiquing: Doctor accused of selling false hope to families (USA TODAY NEWS, NATION, Liz Szabo, USA TODAY)

20131116-002847.jpg
I gave Liz Szabo and USA TODAY the chance to act like a Spike Lee joint and “Do the Right Thing”, the same day their article came out [1]

I gave them the opportunity to prove that their article was a legitimate piece of journalism with some semblance of integrity, and NOT just akin to one of “The Skeptics™ phoned-in “rubber-stamped” yellow journalism hit pieces

Instead, it seems that Liz Szabo and / or USA TODAY decided to act as if they had rolled a Spike Lee joint

I sent an e-mail with 2 editorial corrections, and only one (correcting Lisa Merritt’s comment
link from taking the reader to the 1999 Mayo Clinic report instead of to her comments), was corrected [2]

The 2nd correction which they #FAILED to do, earns them well deserved INSOLENCE
——————————————————————
The article claims:
——————————————————————
Burzynski, 70, calls his drugs “antineoplastons” and says he has given them to more than 8,000 patients since 1977.”
——————————————————————

20131116-004037.jpg
——————————————————————
However, if you select the “8,000 patients” link, the referenced page does NOT indicate that at all [2]
——————————————————————

20131116-064344.jpg
——————————————————————
It advises:
——————————————————————
“That same year, Dr. Burzynski founded his clinic in Houston where he’s since treated over 8,000 patients.” [3]
——————————————————————

20131116-064326.jpg
——————————————————————
Nowhere does it indicate that he “treated 8,000 patients” with antineoplastons
——————————————————————

20131116-064409.jpg
——————————————————————
The question that Liz Szabo and USA TODAY should answer, is:

1. Who is your “fact-checker”, and
2. are they smarter than a 5th grader ?
——————————————————————
In fact, Burzynski’s 2002 Securities and Exchange Commission (SEC) filing advises:

” … 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” [4]
——————————————————————
The article continues:
——————————————————————
“Individual success stories can be misleading, said Arthur Caplan, a professor and head of the division of bioethics at NYU Langone Medical Center”
——————————————————————
The question Arthur Caplan should be asking is:

Why has the United States Food and Drug Administration required Burzynski’s clinical trial patients to fail conventional therapies; such as surgery, chemotherapy, and radiation, BEFORE they are allowed to be treated with antineoplaston therapy ?

If the F.D.A. did NOT impose these restrictions upon Burzynski’s clinical trials, then the question Arthur Caplan raises would be moot
——————————————————————
The article quotes Dr. Jan Buckner as saying:
——————————————————————
“When I hear a story that is way out of the norm, the first question I ask is,

‘OK, is the diagnosis even correct?‘ ”

Buckner said”

“If the diagnosis wasn’t right to start with, it doesn’t matter what the treatment was.”

“Brain tumors are notoriously difficult to diagnose, Buckner says”

“When dealing with rare brain cancer, doctors may disagree about how to interpret imaging results up to 40% of the time”
——————————————————————
I wonder if Dr. Jan Buckner would agree with David Gorski; who is a BREAST cancer oncology specialist, and NOT a BRAIN cancer oncology specialist, who has the presumptiveness to speculate that 3 different medical opinions could have misdiagnosed Tori Moreno in August 1998; who was diagnosed with a very large tumor, about 3 inches in the largest diameter and located in the brain stem, which was too risky for surgery, and about which her parents were told by ALL 3, that Tori’s brain cancer was fatal and, she would die in a few days or at the most, 2-6 weeks, and that there was nothing that could be done, and was finally put on Burzynski’s antineoplaston therapy in October, when she was about 3 ½ months old, and in such condition that they were afraid that she might die at any time, David H. Gorski, M.D., Ph.D., FACS; who claims, “I do know cancer science” , has the audacity, because of his “book learnin'” has the temerity to postulate his “science-based medicine theory” that Miller’s Children at Long Beach Memorial misdiagnosed Tori Moreno’s inoperable stage 4 BSG

David Gorski has the gall to profer that City of Hope misdiagnosed Tori Moreno’s inoperable stage 4 brain stem glioma

David Gorski has the chutzpah to pontificate that Dr. Fred Epstein in New York misdiagnosed Tori Moreno’s inoperable stage IV brainstem glioma [5]
——————————————————————
The article then quotes Peter Adamson, chair of the Children’s Oncology Group:
——————————————————————
“But these therapies may have delayed benefits, taking weeks or months to shrink a tumor

“So patients treated by Burzynski may credit him for their progress, just because he was the last doctor to treat them, says Peter Adamson, chair of the Children’s Oncology Group, an NCI-supported research network that conducts clinical trials in pediatric cancer

Conventional cancer treatment can also cause tumors to swell temporarily, due to inflammation

“A patient who isn’t familiar with this phenomenon may assume her tumor is growing

“When that swelling subsides, patients may assume it’s because of Burzynski, Adamson says”
——————————————————————
This is laughable

In support of this “phenomenon” , the article provides a link to a Canadian web-site [6]

The site posits:
——————————————————————
“RT/TMZ is now widely practiced and the standard of care for appropriately selected patients, we are learning more about the consequences of RT/TMZ”

“One phenomena, termed Pseudo-Progression (psPD)…”
——————————————————————
The problem is that this only applies to “Glioblastoma Multiforme (GBM)”, and the article provides NO proof whatsoever, that any of Burzynski’s “Glioblastoma Multiforme (GBM)” patients have taken “RT/TMZ”
——————————————————————
Additionally, the site cites the reference as:

Sanghera, Perry, Sahgal, et al., “Sunnybrook Health Sciences Odette Cancer Centre” (in press, Canadian Journal of Neuroscience)

(“In press” refers to journal articles which have been accepted for publication, but have not yet been published)

However, the journal article in question was published 1/2010, so it has NOT been “in press” for over 3 years and 7 months [7]

Get your act together, aye, Canada !
——————————————————————
The article rants and raves on and on about FDA inspection reports from as far back as 1998, but at least they did quote Richard A. Jaffe:

“In Burzynski’s defense, Jaffe notes that inspection reports represent preliminary findings

“The FDA has not yet issued final conclusions”
——————————————————————
The article posts this ridiculous claim:
——————————————————————
“Yet the National Cancer Institute says there is no evidence that Burzynski has cured a single patient, or even helped one live longer
——————————————————————
That’s NOT what this seems to suggest [8]
——————————————————————
Then the article quotes pediatric oncologist Peter Adamson, a professor of pediatrics and pharmacology at Children’s Hospital of Philadelphia, in what will no doubt soon be known as a “classic”:
——————————————————————
“He’s a snake oil salesman,” says pediatric oncologist Peter Adamson, a professor of pediatrics and pharmacology at Children’s Hospital of Philadelphia”
——————————————————————
All I’d like to know is, which rock did this clown crawl out from under ?

Dr. Adamson, please advise which “snake oil” has been granted Orphan Drug Designation (“ODD”) from the United States Food and Drug Administration [9], and which “snake oil” has been approved for, and used in, phase III clinical trials ? [10]
——————————————————————
Q: Is it, it the phase 2 trial is finished ?

A: “Mhmm”

Q: but they’re still accepting people ?

A: “Yeah”

Q: on more like a special ?

A: Special basis, and, um, sometimes compassionate grounds

A: “(compassion exception)”

A: “Uh, exceptions

Q: That’s normal ?

A: “Yes”
“So”

A: “(Yes I guess it is a funding issue ?)”

Q: Right

A: “(Like FDA, during the 2nd phase of clinical trials they found the data to be, real, real one, and they gave him the ok to go for 3rd phase of clinical trials, but just to go through this process you would probably need $100,000)”
——————————————————————

20131116-164617.jpg

20131021-200529.jpg

20131021-200553.jpg
——————————————————————
Oh, wait !!

Dr. Adamson, when you say “snake oil”, I take it you are referring to the low-dose chemotherapy that Burzynski uses ?

Dr. Adamson, do you know what a “hack” is ?
——————————————————————
In regards to the Merritt’s, the article has:
——————————————————————
“The couple say that Burzynski misled them about the type of treatment that would be offered, as well as the cost”

My questions about the Merritt’s are:

1. Where is their complaint to the Texas Medical Board ?

2. Where is their lawsuit ? Couldn’t they find an attorney to take their case pro bono ?
——————————————————————
The article continues:
——————————————————————
“Yet even Jaffe has acknowledged that the trialnow in its 17th year — was more about politics than science”

“In his 2008 memoirs, Galileo’s Lawyer, Jaffe called it “a joke.”

“”It was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment,” Jaffe said
——————————————————————
What Liz Szabo and her friends at USA TODAY fail to let the readers know, is that this only applied to one trial:
——————————————————————
Burzynski’s lawyer is obviously referring to the CAN-1 clinical trial mentioned in Burzynski’s 11/25/1997 Securities and Exchange Commission (SEC) filing [11]
——————————————————————
One trial that is retrospective is CAN-1 Clinical Trial
——————————————————————
CAN-1 PHASE II STUDY OF ANTINEOPLASTONS A10 AND AS2-1 IN

PATIENTS WITH REFRACTORY MALIGNANCIES

133 patients
——————————————————————
Clinical trial of patients treated by Dr. Burzynski through 2/23/1996
——————————————————————
FDA has indicated it will not accept data generated by this trial since it was not a wholly prospective one
——————————————————————
The article continues in the same vein:
——————————————————————
“In an interview, Burzynski said developing new drugs is complex and takes time

“Yet the FDA has approved 108 cancer drugs since Burzynski began his trial”
——————————————————————
Ms. Szabo and “pals” conveniently “forgets” to educate their audience that Burzynski was using Fleming’s One-sample multiple testing procedure for phase II clinical trials [13], which requires that if the 1st 20 patients meet certain criteria, 20 additional patients are added [14]
——————————————————————
“Well, we cannot publish until the time is right” (laughs)

Yeah

“If you would like to publish the results of, of a
10 year survival, for instance”

Mmm

“Which we have
Nobody has over 10 year survival in
malignant brain tumor, but we do, and if you like to do it right, it takes time to prepare it, and that’s what we do now
What we publish so far
We publish numerous, uh, publications which were, interim reports when we are still continuing clinical trials
Now we are preparing, a number of publications for final reports
[15]
——————————————————————
Then Fran Visco, president of the National Breast Cancer Coalition makes an outlandish statement, which is quoted in the article:
——————————————————————
“Fran Visco, president of the National Breast Cancer Coalition, describes the FDA’s tolerance of Burzynski as “outrageous.”

“They have put people at risk for a long time,” says Visco, an attorney and breast cancer survivor

“That’s completely unacceptable”

“How can anyone look at these facts and believe that there is a real clinical trial going on … rather than just using the FDA and the clinical trial system to make money?”
——————————————————————
I have a suggestion for Ms. Visco

Take your hypocrisy and ask the American Cancer Society if they are still engaged in this kind of activity:

1. AMERICAN CANCER SOCIETY: More Interested In Accumulating Wealth Than Saving Lives [15]

2. National Cancer Institute and American Cancer Society: Criminal Indifference to Cancer Prevention and Conflicts of Interest [16]
——————————————————————
Then, ask the American Cancer Society, why is it that 10 years ago, estimated breast cancer deaths were expected to be 39,800 (15%), and this year it was 39,620 (14%), which is ONLY 180 LESS than 10 years ago ?
——————————————————————
Estimated Breast Cancer Deaths (Women)-USA
——————————————————————
2013☝39,620 (14%)
2012👇39,510 (14%)
2011👇39,520 (15%)
2010👇39,840 (15%)
2009👇40,170 (15%)
2008☝40,480 (15%)
2007👇40,460 (15%)
2006☝40,970 (15%)
2005👇40,410 (15%)
2004☝40,110 (15%)
2003☝39,800 (15%)
2002
39,600 (15%)
—————————————————————–
American Cancer Society Cancer Facts & Figures (2002-2013)
—————————————————————–
And then ask the American Cancer Society, why is it that 10 years ago, the estimated NEW breast cancer cases were expected to be 211,300 (32%), and this year it was 232,340 (29%), which is 21,340 MORE than it was 10 years ago ?
——————————————————————
Estimated New Breast Cancer (Women) – USA
——————————————————————
2013☝232,340 (29%)
2012👇226,870 (29%)
2011☝238,480 (30%)
2010☝207,090 (28%)
2009☝192,370 (27%)
2008☝182,460 (26%)

2007👇178,480 (26%)
2006☝212,920 (31%)
2005👇211,240 (32%)
2004☝215,900 (32%)
2003☝211,300 (32%)
2002
_-_203,500 (31%)
—————————————————————–
American Cancer Society Cancer Facts & Figures (2002-2013)
——————————————————————
And after that, ask Susan G. Komen how much is spent on legal action to protect her brand, compared to how much is spent on breast cancer research and prevention ?
——————————————————————
Visco, the breast cancer advocate

“I do NOT know why it took YOU so long.”
——————————————————————
The article continues with:
——————————————————————
“Yet hypernatremia is one of antineoplastons’ most common side effects, known to doctors for two decades”
——————————————————————
Yet, “The Skeptics™” refuse to discuss:
——————————————————————
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 [19]

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
——————————————————————
9/1999 – The changing pattern of hypernatremia in hospitalized children [20]

Department of Pediatrics, Texas Children’s Hospital, Baylor College of Medicine, Houston, Texas, USA
——————————————————————
So, after all that, my question for USA TODAY is, does Liz Szabo, Michael Stravato, Jerry Mosemak or Robert Hanashiro have a
journalism degree ?

Because if any of them do, the institution they obtained it from most be so proud of this piece of “fish wrap” you produced

Thank you, USA TODAY, for censoring my 18 comments

I guess you must be (“intellectual”) cowards

At least Forbes had the GRAPEFRUITS to post some of my comments
——————————————————————
You’ve just been served, INSOLENTLY
——————————————————————
USA TODAY, GONE TOMORROW
——————————————————————

20131116-084820.jpg

20131116-085357.jpg

20131116-084833.jpg

20131116-084847.jpg

20131116-084909.jpg

20131116-084924.jpg

20131116-084937.jpg

20131116-085152.jpg

20131116-085218.jpg

20131116-085311.jpg

20131116-085436.jpg

20131116-085528.jpg

20131116-085550.jpg

20131116-085608.jpg

20131116-085629.jpg

20131116-084804.jpg

20131116-084745.jpg
======================================
REFERENCES:
======================================
[1] – 11/15/2013 – USA TODAY NEWS, NATION
Doctor accused of selling false hope to families
Liz Szabo, USA TODAY
——————————————————————
http://www.usatoday.com/story/news/nation/2013/11/15/stanislaw-burzynski-cancer-controversy/2994561/
======================================
[2] – Mayo Clinic – 1999 – report: Lisa Merritt
——————————————————————
https://www.documentcloud.org/documents/816819-mayo-clinic-1999-report.html
======================================
[3] – 2012 – former Burzynski web-site screenshots, Pg 3 of 62;
——————————————————————

Click to access burzynski_fdauntitled_promo_2012.pdf

======================================
[4] – 4/26/2013 – Burzynski: 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:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/26/burzynski-fda-requirements-that-cancer-patients-utilize-more-traditional-cancer-treatment-options-in-order-to-be-eligible-to-participate-in-the-companys-antineoplaston-clinical-trials/
======================================
[5] – 11/14/2013 – Critiquing: Why we fight for patients (Why we fight your patience) TAM 2013, TAM2013, “The Amazing Meeting” 2013 #TAM2013 http://www.theamazingmeeting.com
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/14/tam-2013-tam2013-tam2013-the-amazing-meeting-2013-the-amazing-meeting-httptheamazingmeeting-com-httpwww-theamazingmeeting-com/
======================================
[6] – Phenomenon – Brain Tumour Foundation of Canada
——————————————————————
http://www.braintumour.ca/1649/ask-the-expert-psuedo-progression-gbm
======================================
[7] – Pseudoprogression following chemoradiotherapy for glioblastoma multiforme
Can J Neurol Sci. 2010 Jan;37(1):36-42
——————————————————————
http://www.ncbi.nlm.nih.gov/pubmed/20169771/
======================================
[8] – 9/19/2013 – Critiquing: National Cancer Institute (NCI) at the National Institutes of Health (NIH) CancerNet “fact sheet” :
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/19/critiquing-national-cancer-institute-nci-at-the-national-institutes-of-health-nih-cancernet/
======================================
[9] – FDA Orphan Drug Designation
——————————————————————

Click to access PressRelease_12022008_BZYR(2).pdf

======================================
[10] – 11/7/2013Pete Cohen chats with Sonali Patil, Ph.D., Research Scientist at The Burzynski Clinic:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/07/pete-cohen-chats-with-sonali-patil-ph-d-research-scientist-at-the-burzynski-clinic/
======================================
[11] – 7/9/2013 – Burzynski: The Original 72 Phase II Clinical Trials:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/07/09/burzynski-the-original-72-phase-ii-clinical-trials/
======================================
[12] – 8/21/2013 – 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/
======================================
[13] – 2003 – pg. 94
——————————————————————

Click to access 960.pdf

======================================
[14] – 3/1982 – Biometrics 1982; 38: 143-51
——————————————————————
http://www.ncbi.nlm.nih.gov/pubmed/7082756/
======================================
[15] – 11/9/2013Pete Cohen chats with Dr. Stanislaw Burzynski – Interview #2:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/09/pete-cohen-chats-with-dr-stanislaw-burzynski-interwiew-2/
======================================
[16] – AMERICAN CANCER SOCIETY: More Interested In Accumulating Wealth Than Saving Lives
——————————————————————

Click to access acs.pdf

======================================
[17] – 9/11/2013 – National Cancer Institute and American Cancer Society: Criminal Indifference to Cancer Prevention and Conflicts of Interest:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/11/national-cancer-institute-and-american-cancer-society-criminal-indifference-to-cancer-prevention-and-conflicts-of-interest/
—————————————————————
[18] – 11/13/2013 – The War on Cancer (I don’t think it means, what you think it says it means) #Winning?
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/11/13/httpcancer-orgacsgroupscontentepidemiologysurveilancedocumentsdocumentacspc-036845-pdf/
======================================
[19] – 4/24/2013 – Burzynski: HYPERNATREMIA:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/24/burzynski-hypernatremia/
======================================
[20] – 9/1999 – Pediatrics. 1999 Sep;104(3 Pt 1):435-9
——————————————————————
http://www.ncbi.nlm.nih.gov/pubmed/10469766/
======================================

20131116-002912.jpg