Burzynski: The Movie, directed by Eric Merola

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Burzynski: The Movie
directed by Eric Merola
© 2011 Burzynski Movie
Featuring Stanislaw Burzynski, M.D., Ph.D., Julian Whitaker, M.D., and Richard Jaffe, Esq.

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"Eric Merola's 'Burzynski' charts how a Texas medical doctor and biochemist discovered Antineoplastons ... only to bring down the full force of the medical establishment, which has laid assault to him in the most stupefying, devious and costly manner." -- The Lost Angeles Times, June 3, 2010

"Top Ten Best Film of 2010. It will give you goosebumps and bring tears to your eyes. Heroic and inspiring. This is what an advocacy documentary should look like. Measured, balanced and relentlessly clear." -- The Movie Film Show, January 27, 2011

"A wonderful film ... grippingly told ... compelling." -- Dr. Mehmet Oz, the Dr. Oz Show, May 17, 2011

"... dramatic expose of the FDA and its incestuous relationship with Big Pharma as it seeks to first discredit, then co-opt Burzynski's discovery." -- Variety, June 3, 2010

"No one appears to contest the efficacy of his treatment; the problem ... is a pharmaceutical industry with nothing to gain -- and much to lose -- from the introduction of a highly successful, nontoxic competitor to chemotherapy and radiation." -- The New York Times, June 4, 2010

CANCER IS SERIOUS BUSINESS

CLICK HERE TO SEE "BURZYNSKI: THE MOVIE" -- ILLUSTRATED SCREENPLAY

In 1994, I started working for Dvorit Samid. She didn't let me know that one of those compounds is from Dr. Burzynski. You know, she just said, "Phenylacetate," and show me all the published papers about phenylacetate and its analogs, and their anti-cancer activity.

It was quite amazing in the lab, because if you find a compound that has anti-cancer activity, and then you find a bunch of analogs, it's like you stumbling upon a pile of gold. So people would think and say, you know, "patents, patents, patents," you know, that sort of thing.

Dvorit, under her leadership, we found a lot of biological activities in these compounds. So it would have anti-cancer activity. So the scientists at Johns Hopkins tried to patent these compounds, but of course, Dvorit was working with Elan Pharmaceutical company at that time, so those guys at Johns Hopkins didn't have any chance of patenting those compounds.

In 1995, in the lab, I was still with Dvorit, but I smelled fishy, something is not right. The first paper Dvorit published about phenylacetate, if you look at the methodology section, there's a "BRI" abbreviation. She got materials from the Burzynski Research Institute, Houston, Texas. But it didn't say, "Burzynski Research Institute." For us, as scientists, it's a funny practice.

In the past, when the NCI (National Cancer Institute) or its assigned entity is conducting an alternative cancer therapy [clinical trial], they always alter the protocols and let it fail -- to discredit the therapy. But this time the pharmacokinetic data shows that they didn't do it right. And most scientists will not look at it carefully. Because papa is telling you something, and you don't question him.

They sometimes have a creed -- it's to 'separate the medicine from the medicine man.' Of course these 'higher-ups' at the NCI, or whatever, they think 'Hey guys, we've been doing this for years. We know what's going on.' So they think, 'Well, we know what's going on with phenylacetate, phylacetylglutamine." If you can outsmart the medicine man, you can cut a piece of the pie for yourself. That's the name of the game.

If you cannot be the first one, if you can be the second one, and be bigger than the first one -- Steal. Why not? That's the mentality. Under the capitalist sun, there is nothing sacred. Money talks.

-- Li-Chuan Chen, Ph.D., National Cancer Institute Scientist 1991-1997, in Burzynski: The Movie, directed by Eric Merola

[admin]

Screenplay:

[Transcribed from the Movie by Tara Carreon]

[NARRATOR] This is the story of a medical doctor and Ph.D. biochemist who has discovered the genetic mechanism that can cure most human cancers.
The opening 30 minutes of this film is designed to thoroughly establish this fact, so the viewer can fully appreciate the events that follow it.

[Sgt. Rich Schiff] [Congressional Subcommittee hearing, Feb. 29, 1996] My name is Sergeant Ric Schiff. I am an 11-year veteran of the San Francisco police department. I hold the department’s highest medal of honor for bravery. That used to mean a lot more to me than it does now.
What I’d like to talk to you about today is my now-7-year-old daughter.
This is an identical twin. Her sister is now dead.
Her sister, when she was 4 years old -- Crystin -- developed a highly malignant brain tumor that had spread throughout her spine and her brain.
The doctors told us that we had really two options: (1) take her home and let her die, or (2) bring her in for massive dosages of chemo and radiation simultaneously. In either event she was going to die. They were quite certain of that. And very quickly.
Believing her only chance to be the standard route, we gave her the chemo and radiation. It burnt her skull so bad she had second degree burns and her hair never came back. To change her diapers we had to wear rubber gloves because her urine was so toxic and it burned her.
At the end of 6 months, miraculously she survived the standard treatment, although there was a high expectation she wouldn’t. She still had cancer. We were told “sorry, we’ve done everything we can, now she’s going to die, probably within a couple of months.” My wife and I, choosing not to accept that, started reading. The first book I picked up, the third chapter, discussed Dr. Burzynski.
As you may guess, I have some expertise in fraud. In fact, I’m quite certain there are enough attorneys in the room that I could be voir dired as an expert in fraud. And I conducted my own investigation. I have no doubt the man is not a fraud. I have no doubt that he does what he does out of earnest belief that his medicine works.
Now, you are in a position to judge for yourselves whether is works or not, but it’s well established by the FDA that it’s non-toxic.
Eighteen months later, we took my daughter off the Antineoplaston. She had not died. She had no signs of tumor. She remained free for eighteen months of cancer. Within a month, the cancer was wide-spread in her brain. We put her back on Burzynski’s -- by the way, at the objections of our doctors, who for some reason felt that it had failed her -- we put her back on, and within nine weeks, the tumor was completely gone. She died last July of neurological necrosis. Her brain fell apart from the radiation. The autopsy showed that she was completely cancer-free.
Out of fifty-two cases of that disease ever, no one died cancer-free, just Cryssie.
So she didn’t die of a terminal illness. She died of my inability to care for her properly. And she died from bad advice. She died because there is a government institution that disseminates false information, and is not looking out for the welfare of the people.
You know, ladies and gentlemen, I swore an oath eleven years ago, and I think most of us in this room swore it at one time or another, to uphold the Constitution: it says "life" right in the beginning.

BURZYNSKI

[Dr. JULIAN WHITAKER] I first heard of Dr. Burzynski back in the late 1980’s when he was in a battle with the Texas Medical Board, and the FDA, regarding his innovative approach to cancer.
I wasn’t surprised by that. Anyone who is innovative in medicine creates waves in the medical system. However, in his case, I was continually surprised that they didn’t put him out of business. I kept hearing about him.
So in the mid 1990’s I said, “Dr. Burzynski, I want to come down and visit your clinic, and find out what you’re doing. It’s very new to me.”
When I arrived, he had seven charts ready for me to review that had been reviewed by the National Cancer Institute, who also made a site visit the year before.
The National Cancer Institute reported that these seven patients were either in complete remission, or there was substantial improvement. I was astounded.
Dr. Burzynski had MRIs of brain tumors, known to be almost universally fatal ...
that had simply disappeared.
It was obvious to me that Dr. Burzynski had made the most important discovery in cancer treatment ever.
It’s what we have been looking for.

[NARRATOR] A Polish native ...
named Stanislaw Burzynski ...
attended Lublin Medical University where he graduated first in his class at age 24, and then received his Ph.D. in biochemistry the following year.
While undergoing his research to acquire his Ph.D., Dr. Burzynski made a profound discovery. He found a strain of peptides in human blood and urine that had never before been recorded in biomedical research.
As his curiosity in these peptides evolved, he made another profound observation:
people who were inflicted with cancer ...
seemed to lack these newly-discovered peptides
in both their blood and urine ...
while those who were healthy and free of cancer appeared to have an abundance of these peptides.
Dr. Burzynski theorized that if he could somehow provide a way ...
to chemically extract these peptides ...
from the blood and urine of healthy donors ...
and administer these peptides ...
to those with cancer ...
perhaps it would be useful ...
in treating the disease.

[Dr. JULIAN WHITAKER] Now, discovering something in the urine at that time that had not been discovered before ...
is like finding a whole bunch of islands ...
ten miles off the coast of Miami.
It came as a big surprise.
All of the sudden he was besmirched as the urine doctor.
We forget that extracting things from the urine is an established medical modality.
Tens of millions of women have been swallowing ...
extracts of horse urine, Premarin, for decades.
But all of the sudden it was abhorrent to our sensitivities.
Well, Dr. Burzynski now synthesizes all of the Antineoplastons.

[NARRATOR] Dr. Burzynski’s manufacturing facility ...
in Stafford, Texas ...
where his Antineoplastons ...
are now synthesized ...
is a multi-million dollar ...
46,000 square-foot facility ...
which staffs five engineers ...
four chemists ...
three pharmacists ...
four medical doctors ...
and four researchers.

[Dr. STANISLAW BURZYNSKI] When we started in the 1970’s ...
now is forming a completely new approach to cancer treatment ...
which is called “gene-targeted therapy”. Antineoplastons are medicines which work on the genes which are causing cancer ...

[Antineoplastins target the specific genes that allow cancer to grow and flourish]

And now there are 25 medications which belong to the family of gene-targeted therapy, which are approved by the FDA in the United States. The problem with these medicines is that they don’t cover as many genes as Antineoplastons. Many of them simply work on single genes, and this is not enough to have long-term responses. A single medicine is not going to do it. It’s not enough.

[There are currently over twenty-five FDA-approved gene-targeted cancer drugs on the market today. Many of them can only target single genes.]

Antineoplastons work on close to one hundred different genes.

[Antineoplastons work on close to one hundred different genes.]

[NARRATOR] Our bodies contain two categories of genes that allow cancer to flourish: oncogenes, and tumor suppressor genes. When someone has cancer, they have a higher level of oncogenes switched on, with a higher level of tumor suppressor genes switched off.

[Two categories of genes that allow cancer to grow: (1) Oncogenes, (2) Tumor suppressor genes.]

The goal is to tell the body to both switch back on the tumor suppressor genes, and turn off as many oncogenes as possible.

[Dr. STANISLAW BURZYNSKI] Statistically, every day, one out of 10,000 cells in our body may develop in the wrong way, and some of these cells may become cancerous cells.
But why we don’t develop cancer, all of us, is because we have a protective system, we have Antineoplastons that will immediately force these malignant cells to die, by working on the genes, by turning on the genes which fight cancer, and turning off the genes which promote cancer.
As long as we have proper amount of Antineoplastons in our system, we should not develop cancer. If we are deficient, then we can develop cancer.
So this means that I put together the theory of the second quote-unquote immune system in our body.

[NARRATOR] Today, Dr. Burzynski is permitted by the FDA to treat cancer patients using Antineoplastons in FDA-approved clinical trials. Since brain cancer is one of the most difficult types of cancer to treat, he places a heavy focus on brain cancer in his clinical trials.

[FDA permits cancer patients to be treated using Antineoplastons in FDA-approved clinical trials. Since brain cancer is one of the most difficult types of cancer to treat, he places a heavy focus on brain cancer in his clinical trials.]

[JODI FENTON] On May 15th of 2000, I was diagnosed with an inoperable, stage three, anaplastic astrocytoma brain tumor.

[Anaplastic Astrocytoma brain cancer, clinical trial]

Following my diagnosis I was told that I had six to eighteen months to live. So I met with an oncologist here in Los Angeles and in San Francisco, and they were telling me at that time, the oncologist told me, that the protocol for me would be to do Temodar®, which is a chemotherapy, followed by a course of radiation.
I asked them what that treatment would get me, and they said maybe five years.

[Temodar (temozolomide), Median survival time for Anaplastic Astrocytoma patients treated with Temodar (chemotherapy): 13.6 months. SOURCE: "Basis for Temozolomide, Approval for Refractory Anaplastic Astrocytoma, CL Tendler, MD-VP, Oncol. Res.; Oncology Drug Advisory Committee; Shering-Plough Res. Inst., March 13, 2003; pg. 7]

"Maybe five years of life?" So, of course, I asked what would happen after five years, if I get to that five years. And they said, “Well, we’ll see what’s available at that time,” meaning, I would perpetually be on a course of treatment. Didn’t sound good enough for me.
Also at that time, I had heard about Dr. Burzynski in Houston, and I found out about Dr. Burzynski through a friend of mine.
But I met with a prominent neurosurgeon here [Dr. Keith Black of Cedars-Sinai], who wrote off Dr. Burzynski.
And he told me point blank that, “Antineoplastons don’t work.” But Dr. Burzynski’s treatment really sounded right to me.
So I started on his treatment on June 6, of 2000. In December of 2000, all that was left of the tumor was scar tissue. And again, this was confirmed through an MRI.
In October of 2001, I stopped Antineoplaston therapy altogether. I’ve had annual MRIs since that time, so over the course of the last eight years, annual MRIs have confirmed that all that’s left of the tumor is scar tissue. And I’ve been off treatment for that entire time. So Dr. Burzynski cured me of a brain tumor.

[Jodi Fenton’s medical records: Diagnosis]

[NARRATOR] If we review Jodi Fenton’s medical records ...
who was known at this time as Jodi Gold, before she was married in 2005 ...
it shows she underwent an MRI at St. John’s medical center in Los Angeles on May 11th of 2000 ...
where they found a two centimeter mass which they suspected was cancer.
The pathology department at St. John’s performed a biopsy four days later ...
and confirmed that she did indeed have a malignant brain tumor.
Ordinarily the FDA requires that anyone that wishes to be a part of Dr. Burzynski’s trials ...
must first have already undergone chemotherapy and radiation, and failed.
However, since Jodi’s tumor was so aggressive, and her prognosis severely grim, she managed to get "special exception status" to be placed into this trial ...
without undergoing any other prior treatment whatsoever.

[Jodi Fenton’s medical records: Results]

[NARRATOR] An MRI on June 1st of 2000, revealed the size of the enhancing portion of Jodi’s tumor, which was the part of her tumor that was the most aggressively growing. On June 6th, she started Antineoplaston treatment.
And by July 3rd, only a month after starting treatment, the enhancing portion of her tumor was gone.
Her tumor ...
remained non-existent ...
up until September of the following year ...
when she stopped ...
her antineoplaston therapy altogether.
It’s one thing to be shown a single anecdotal case with this type of brain tumor, and it’s another to simply compare clinical trial data of inoperable anaplastic astrocytoma patients treated with toxic radiation and chemotherapy, versus clinical trial data using only Dr. Burzynski’s non-toxic Antineoplaston therapy.
A 2005 clinical trial report using only radiation and chemotherapy found that 5 of 54 patients, or 9%, were cancer-free at the end of treatment, while a 2008 clinical trial report, using only Antineoplastons, found that 5 of 20 patients, or 25%, were cancer-free at the end of treatment, with no toxic side-effects. Jodi Fenton is one of them.

[FDA-supervised clinical trial data for Anaplastic Astrocytoma patients: Treated with radiation and chemotherapy: 5 of 54 patients (9%) cancer free. SOURCE: Temodar, Product Information (Clinical Studies); Schering-Plough Research Institute; Rev. 6/06; pg. 5 vs. Treated only with Antineoplastons: 5 of 20 patients (25%) cancer free. SOURCE: Phase II Study of Antineoplastons A10 & AS2-1 (ANP) In Patients with newly diagnosed Anaplastic Astrocytoma: A Preliminary Report; SR Burzynski, M.D., Ph.D., et al.; Neuro-Oncology; Vol. 10; No. 5; October 2008; pg. 821]

[Dr. JULIAN WHITAKER] If Jodi Fenton had undergone the therapy originally prescribed to her, her life would have been very different.
Now she is alive, well, and prospering.
It’s as if she had a bacterial infection, and Dr. Burzynski treated it with antibiotics.

[JODI FENTON] Four years after my diagnosis, I had run into one of the neuro-oncologists I had met with [Dr. Keith Black of Cedars-Sinai], and told him that I had gone to Dr. Burzynski, and I was cured. And he kind of wrote it off.
I was very excited to tell him that I was cured, and he really burst my bubble about it. So it was somewhat depressing for me.
Another doctor that I have, when I told him that I had anaplastic astrocytoma ...
he was very excited. He was like, “bleep! bleep! bleep! I can’t believe this is you, because do you know what the prognosis for this is?” And I said, "Yes." He said, “I can’t believe you survived this.” And he was very excited for me.

[Dr. JULIAN WHITAKER] Now, if you are ever going to go into cancer treatment, you do not want to go into childhood brain tumors. Because childhood brain tumors, by-and-large, are 100% fatal.
This would be the worst class of cancers to treat.
But he began getting enormous results.

[Dr. STANISLAW BURZYNSKI] Arguably, the worst type of cancer is inoperable brainstem glioma. Usually it involves the brain of children. And unfortunately, there is very little that can be done. Radiation is the only treatment which can be used to slow down the progress.

[One of the most difficult types of cancer to treat is Inoperable Brainstem Glioma. It usually occurs in the brain of a child. Radiation is the only treatment available.]

So that’s the type of tumor for which there is no curative treatment, no chemotherapy which is approved, and numerous clinical trials were performed but failed in the past.
We selected this type of tumor because we would like to prove the point, beyond any doubt, that this type of cancer can be cured by the use of Antineoplastons. And we already have proof that it can be cured.

[Brainstem Glioma: Brain Cancer, Clinical Trial]

[ROBIN RESSEL] She was diagnosed in March of 1996. She was eleven, and pretty much just started having really bad double vision is how we discovered it. We went to the eye doctor, and that’s when they did the MRI, and discovered it was a brainstem glioma. And they explained that hers was diffused, where it was like the healthy tissue and the cancerous tissue were swirled together, so of course surgery wasn’t an option. And with the radiation they suggested, her prognosis was probably going to be about eight to eighteen months.

[JESSICA RESSEL] The thing is, with the radiation, what it would do to you, from what I understood, was they would shoot the beam through your ears ...
and the beam would burn your healthy and your cancerous cells outside-in. So all your hair around your ears would be gone, never grow back ...
your ears would become deformed and burnt, you would become deaf, because you couldn't hear, it would also destroy your pituitary gland ...
which is the gland that helps you grow as you hit puberty.

[ROBIN RESSEL] Yeah, she was eleven at the time, and that was a real concern I had.

[JESSICA RESSEL] And it would make you stay in an 11-year-old body. And basically, you’d become in a vegetative state, where you couldn’t take care of yourself, which wasn’t a very good quality of life.

[ROBIN RESSEL] Because my big concern was, with the oncologist originally that we were dealing with was ...
how it was going to effect her development, and when she started to enter the teenage years, starting a period, and growing and developing, and he just looked at me and he said, “Well, frankly, Mrs. Ressel, she’s not going to live that long.”

[DAN RESSEL] What she would have to go through in those extra months, that would be horrible.
I wouldn’t want to go through it. Why do it?

[ROBIN RESSEL] You’re handed a death sentence anyway, so what was the point of the radiation?

[DAN RESSEL] You know, then, you have to say, "Okay, modern medicine doesn’t have an answer.
Let’s find our own.”

[Jessica Ressel’s medical records: Diagnosis]

[NARRATOR] Jessica Ressel’s brainstem glioma was confirmed ...
by an MRI ...
in Springfield, Missouri ...
and the Children’s Hospital ...
of St. Louis Missouri.

[KY-3 NEWSCASTER] [KY-3 NEWS SPRINGFIELD, Nov. 19, 1996] Jessie Ressel is riding on the best news she’s had since March.
She and her parents now believe they are on their way ...
to a cure for what doctors had said was an incurable brain tumor.
Here at the Burzynski Clinic in Houston, Texas ...
the Ressels have found an experimental drug they could only dream of eight months ago.
That’s when Jessie ...
was still a fifth-grader ...
at a Catholic elementary school in Springfield.
It’s when one of her eyes started crossing in. She started seeing double.
It’s when Jessie went to the doctor and learned she had one of the most aggressive kinds of brain cancer, a malignant tumor doctors said would kill her within months ...
and that radiation would only give her a little more time.

[JESSICA RESSEL (age 11)] And I would live for only three months ...
and like live in like pain ...
and that’s it.
And not like a fun life. Yeah, I’d still die.

[KY-3 NEWSCASTER] Today the medical pictures ...
tell a different story.
You can see the improvement immediately ...
just looking at Jessie’s eyes now, compared to last May.

[Jessica Ressel’s medical records: Results]

[NARRATOR] An MRI on May 7th of 1996, revealed the size of the enhancing portion of Jessica’s tumor.
One month into starting Antineoplaston treatment, her tumor disappeared.
However, given the aggressive nature of this type of tumor, it quickly returned in August ...
and remained until November. In which time Dr. Burzynski doubled her Antineoplaston dosage ...
until her tumor went away in December.
Only to return again in January of 1997 ...
stayed around until April ...
and finally disappeared in May of 1997, one year after starting Antineoplaston treatment.
Jessica’s tumor ...
remained non-existent ...
up until October 2001 ...
when her brainstem glioma ...
was considered ...
resolved.

[ROBIN RESSEL] There were very few doctors that you would tell them you were seeing Burzynski, that would be kind of encouraging and positive with you. Most of them, they would hear the name "Burzynski," and they wouldn’t want to deal with you, because they were afraid.
I am so relieved we found Dr. Burzynski ...
because literally it did save her life.
And here she is now, 24 ...
and she’s got a little boy who is almost 5 ...
and then she has her second baby will be born in October. We just found out she’s having a little girl.

[NARRATOR] Again, it’s one thing to observe a single anecdotal childhood brainstem glioma survivor, and it’s another to see the results from FDA-supervised clinical trials treating Jessica’s type of cancer.

[FDA-supervised clinical trial data for Childhood Brainstem Glioma]

Here is a table illustrating studies published in 2006 ...
comparing the results of different childhood brainstem glioma treatments.
There were three groups treated with radiation and chemotherapy ...
and two groups treated with Dr. Burzynski’s Antineoplastons.
Out of all three groups treated with radiation and chemotherapy, only 1 of 107 patients, or 0.9%, were cancer free after treatment. However, this patient did not live beyond five years, presumably being devastated by the amount of radiation and chemotherapy. Out of both groups treated with Antineoplastons, 11 of the 40 patients, or 27.5%, were cancer-free after treatment. And 11 of the 40 patients, or 27.5%, lived more than five years. Most of these brainstem glioma survivors ,who were not previously subjected to toxic chemotherapy and radiation before starting Antineoplaston treatment, have gone on to enjoy full healthy lives.

[FDA-supervised clinical trial data for Childhood Brainstem Glioma: 1. Treated with radiation & chemotherapy: 1 of 107 patients (0.9%) were cancer free. No one lived 5 years (0%). 2. Treated with Antineoplastons: 11 of 40 patients (27.5%) were cancer free. 11 of 40 patients (27.5%) lived 5 years. SOURCE: "Treatment of Diffuse, Intrinsic Brainstem Glioma in Children"; Pediatric Drugs; 2006; Vol. 8, No. 3, pg. 172; Mandell et al., Broniscer et al., Lashford et al., Burzynski et al.]

[Dr. STANISLAW BURZYNSKI] So the good news is that cancer can be cured. The worst type of cancer can be cured. For good. The people who are surviving, they live normal life. No side-effects from the treatment, no symptoms, no sign of tumors -- back to life. We started some of them as children, and they have their own three children. There is no impairment of fertility. They just live normal life. The bad thing, however, is that we know that we can help not everybody, but some of these patients. Well, if about 30% of patients can survive over five years, and a number of them live over ten years, without any sign of cancer, that’s a good thing. But obviously, this is just the beginning. We need to perfect this. We need to introduce the newer generation of Antineoplastons, which we call “second and third generation of Antineoplastons,” to make the treatment more effective, to cover a broad spectrum, and to be easier to administer.

[Adrenocortical Carcinoma with metastasis to the lungs and liver: adrenal, lung, and liver cancer, clinical trial, at six months old]

[SARAH HILL] They came back, they said she has this large baseball-sized tumor in her abdomen. And not only that, but it’s in her kidney, it was like everywhere, it was like in her liver, and her kidney, and her lungs. So here we are thinking, basically, this child has literally a few months to live, is basically what they told us. At that point they said, “Well, we think we can get the original tumor out.” So they had this surgeon, he was able to go in, he got the whole tumor. She did lose her left kidney and her left adrenal gland.
And it was four drugs, and it was like eight pages of side-effects, and very little hope that it would even work. Because the drugs were: Mitotane ...

[MITOTANE CHEMOTHERAPY: Appropriate studies have not been performed to find out Mitotane’s safety or effectiveness in children. SOURCE: The Mayo Clinic, 2010 (mayoclinic.com)]

Doxorubicin ...

[DOXORUBICIN CHEMOTHERAPY: Side effects: Leukemia, Heart Failure, Infertility, Vomiting, Mouth Sores. Nickname “Red Death” SOURCE: American Cancer Society 2010 (cancer.org) How Doctors Think, J. Groopman, 2007, p. 49]

Etoposide ...

[ETOPOSIDE CHEMOTHERAPY: Side effects: Leukemia, Nerve Damage, Inability to Fight Infections, Vomiting. SOURCE: American Cancer Society 2010 (cancer.org)]

and Cisplatin.

[CISPLATIN CHEMOTHERAPY: Side effects: Kidney Damage, Hearing Damage, Nerve Damage, Infertility, Vomiting. SOURCE: American Cancer Society 2010 (cancer.org)]

And they told us, "Admittedly, this is the most toxic regimen that we have.” We have a 6-month old with one kidney, and the side effects were kidney failure, hearing failure, leukemia, other kinds of cancers coming from this, and I was just like, even if she’s going to pass away, I can’t do this to her. I can’t. Because, it's like, why would I want her last few months of life to be miserable?

[STEVE HILL] I didn’t know what to do. I just knew that I didn’t want to put her through all that intense, high-dose chemo, and miss out on what might be the last bit of time that we have with her.
Because I had talked to my uncle -- he’s in his 60’s now -- but in 1969, my cousin, his daughter, was like 3, and she got cancer of some kind. And he told me about what that was like in that time. And they just kept giving her more chemo, and more chemo, and more chemo, and then finally we had this long, several-hour conversation one day, and he told me, I asked him, because I was trying to prepare myself, I said, what is it like when a doctor tells you, "That’s it. I can’t do any more.”
And my uncle Ray told me that for the last few weeks of my cousin’s life, they celebrated Christmas once a week. And they had a Christmas and a birthday once a week until that was it.
And I just, I was putting myself in his shoes, and I was just thinking that I couldn’t watch my daughter whither away, and that if I wanted to be, at least I wanted whatever time I had to be happy -- as happy as could be anyway. I don't know, not just watch her whither away from chemo that’s not doing any good any more.

[SARAH HILL] We had actually asked the endocrinologist at M.D. Anderson about Dr. Burzynski, and he told us he was a quack, and that there was no evidence that that worked ...
but at that point, I was like, “Well, yours doesn’t really work either.”

[MITOTANE CHEMOTHERAPY: Approved: July 8, 1970. Derived from DDT (insecticide). SOURCE: Food and Drug Administration, 2010 (fda.gov)]

[STEVE HILL] The other thing that I did, on the FDA’s website you can look up the date on which any drug was granted FDA approval. And I realized that the oldest drug they wanted to give her had come out in the early 1970’s.

[DOXORUBICIN CHEMOTHERAPY: Approved: December 23, 1987. SOURCE: Food and Drug Administration, 2010 (fda.gov)]

The newest drug they wanted to give Kelsey came out around 1988.

[ETOPOSIDE CHEMOTHERAPY: Approved: November 10, 1983 [SOURCE: Food and Drug Administration, 2010 (fda.gov)]

And I realized, this isn’t the cutting edge of technology. They’re giving us the same old stuff.

[CISPLATIN CHEMOTHERAPY: Approved: December 19, 1978 [SOURCE: Food and Drug Administration, 2010 (fda.gov)]

I just thought, well, this is ridiculous. It felt to me like they were grasping at straws.
I was doing all that research, and Sarah and Susan found the Burzynski Clinic.
Sarah said, “I want to take her there.”
You know, I looked at it like, well, you know, if she’s got approximately 9 months to live, then we come over here and we don’t have all the side-effects ...
well, you know, in 9 month’s time, which am I going to be better off doing, if the ending result is the same?

[Kelsey Hill’s Medical Records: Diagnosis]

[NARRATOR] Upon the removal of Kelsey’s left kidney and left adrenal gland ...
her diagnosis was confirmed ...
at the University of Texas Medical Branch ...
and again at ...
M.D. Anderson Cancer Center ...
where, a month later, M.D. Anderson also confirmed ...
that Kelsey’s cancer ...
had spread to her lungs.
After desperately researching Kelsey’s situation ...
her family decided to decline all chemotherapy treatments offered by M.D. Anderson ...
and instead, enroll Kelsey into one of Dr. Burzynski’s clinical trials.
By this time, Kelsey’s cancer had also spread into her liver.

[Kelsey Hill’s Medical Records: Results]

[NARRATOR] After starting her Antineoplaston treatment ...
the tumor in Kelsey’s liver ...
was gone by August of 2007.
CT scans of her chest revealed six tumors in her lungs at the start of treatment.
One-by-one ...
the tumors in Kelsey’s lungs ...
began to go away ...
leaving one small spot ...
four years later ...
which was deemed to be inactive ...
and most likely scar tissue.
Today, Kelsey Hill is considered to have had a complete response to her Antineoplaston treatment.
Since Dr. Burzynski began treating cancer patients with Antineoplastons, he has successfully treated virtually every type of cancer, relieving thousands of families from across the world of this dread disease.
Yet, unlike other clinical trials, which are supported by billion-dollar pharmaceutical companies ...
and are often assisted by large tax-funded research grants from the National Cancer Institute, the United States government currently prohibits any taxpayer money to be granted to Dr. Burzynski’s FDA-approved clinical trials.

[Dr. STANISLAW BURZYNSKI] A single Phase 3 trial will cost about twenty-five million dollars. So how many can you run? You may run a few at best.
Nobody is giving me any money for that. We have to make money for that. And it’s twenty-five million dollars, okay? Some other pharmaceutical companies who come with an idea, they go to the National Cancer Institute, and they receive a handsome grant, fifteen million dollars, whatever. And they do clinical trials.
Nobody has given me any money, okay? I am working like in the war-time condition, okay? Like working somewhere in the Gaza Strip or West Bank, okay? When the bombs are falling, you still have to treat patients, and we still have to do Phase 2 clinical trials.

[National Cancer Institute annual budget: $5,200,000,000. SOURCE: Office of Science and Technology, NIH 2010 budget]

[NARRATOR] Given the existence of a treatment that is curing cancer at a rate that traditional medicine could only dream of, and doing so without any damaging side-effects ...
most would assume that every penny of our tax dollars ...
allocated for cancer research would be thrown in Dr. Burzynski’s direction.

[Dr. JULIAN WHITAKER] The problem that we face, however, is that a huge financial house has been built on the paradigm of purging the body of cancer cells.
Burzynski’s discovery means that the foundation, the walls ...
and the roof of that house, need to be replaced.
Think about it. You know, you’ve got thousands of doctors in oncology, and in oncology residency programs. You’ve got the pharmaceutical industry pumping out chemotherapeutic agents every month. There are all kinds of machines that deliver radiation. You’ve got all this stuff in the war on cancer. And it’s trillions of dollars.
I find it very interesting ...
that we have all these walks ...
for the cure of cancer.
You’ve got all the wristbands. You’ve got all the donations.
We’re going to find a cure this decade.
All this money keeps pouring in, and it all goes to the same guys.

[PhRMA: New Medicines. New Hope.]

[NARRATOR] The pharmaceutical industry is arguably the most profitable industry on our planet ...
with its profits being triple that of all of the Fortune 500 companies.

[Median Annual American Pharmaceutical Company Profits: 20%. Median Annual Profits for All of the Fortune 500 Companies: 6.3%. SOURCE: Fortune 4/30/07 Company Annual Reports, based on 2006 figures.]

Rising profits result in rising stock prices.
The only way this industry can sustain this profitable momentum ...
is by continuing to introduce new patented drugs.
And since the pharmaceutical industry relies on the FDA as its gatekeeper to introduce these new drugs, it’s in their best interest to insure the FDA remains as compliant as possible.
And since the FDA is also an office of the United States government, it’s in the government’s best interest to preserve one of its most powerful industries.
The former editor-in-chief of the New England Journal of Medicine, Dr. Marcia Angell ...
has been very outspoken with the idea ...
that it’s time to take the Food and Drug Administration back from the drug companies.
In 1992, Congress put the fox in the chicken coop.
It passed the Prescription Drug User Fee Act, which authorizes drug companies to pay “user fees” to the FDA for each brand-name drug considered for approval.
The User Fee Act put the FDA on the payroll of the industry it regulates.
And it has drastically changed the way it operates.
The part of the agency that reviews new drugs now gets more than half of its money from the pharmaceutical industry.
The FDA’s coziness with industry is underscored by the composition of its 18 advisory committees, outside experts who help evaluate drugs.
Incredibly, many of these advisers work as consultants for drug companies.
The FDA behaves as though the pharmaceutical industry is its user, not the public.
In 2010, the fee revenue paid by the pharmaceutical industry to the FDA has risen to over a half a billion dollars annually.
PhRMA now pays over $1.4 million per application for most cancer drugs submitted to the FDA, to ensure a timely approval.
It’s important to understand that neither Congress ...
or the FDA had requested this new fee structure to occur.
Instead, PhRMA itself went to Congress and imposed these new fees onto the FDA ...
in essence purchasing the FDA’s drug evaluation department from both the government ...
and the public.
In a 2007 health policy report ...
sponsored by Pfizer ...
supporting the renewal of these user fees ...
they revealed that the median review time for priority drugs ...
those for serious life-threatening diseases ...
that lack satisfactory treatments, such as cancer ...
was sped up from 21 months in 1993 to 6 months in 2004.
Dozens of cancer therapies have been reviewed and approved ...
within 3 or 4 months.
Meanwhile, Dr. Burzynski, his patients, and other supporting scientists, have made every conceivable effort to get the FDA ...
and thus the government, to cooperate in the research, review, and approval of Antineoplastons, since 1977.

[The United States Government: STATE LEVEL: The Texas Medical Board; FEDERAL LEVEL: The Food and Drug Administration, The NATIONAL CANCER INSTITUTE, PhRMA vs. Stanislaw Burzynski, M.D., Ph.D., and his past, present, and future cancer patients]

[1. STATE LEVEL: The Texas Medical Board vs. Stanislaw Burzynski, M.D., Ph.D., and his past, present, and future cancer patients]

[Dr. STANISLAW BURZYNSKI] Before I started, I asked the lawyers for the advice: "Can I use experimental treatment -- which was the treatment of Antineoplastons --
can I use this in my private practice, and can I be involved in cancer research?"
Simple, as the private company.

[NARRATOR] Dr. Burzynski’s attorneys investigated both state and federal law to find out if it was legal for him to start his own biomedical research company ...
making Antineoplastons, and administering them to his patients within his private practice.
They found that according to both the Texas state and federal law ...
the use of any drug, or new drug, can be used to meet the immediate needs of the patients of a licensed doctor, particularly when there was no other available option for them.
The law stated that such activity was not governed at the time by the Texas Food, Drug and Cosmetic Act, and is not otherwise unlawful under the laws of the state of Texas.
However, Dr. Burzynski would not be legally allowed to introduce or deliver Antineoplastons into interstate commerce. Which means, he had to keep his activities only within the state of Texas to avoid breaking any federal laws.
As long as he did this, his actions were not within the regulatory authority of the FDA.
However, once word began to spread that Dr. Burzynski was successfully treating what was once considered terminal incurable cancer patients, people began traveling from all over the country to receive Antineoplaston treatment.

[Texas Medical Board]

[Dr. STANISLAW BURZYNSKI] For a long time, I didn’t have any contact with Texas Board of Medical Examiners, until around 1984, some of my patients told me that they were approached by the agents sent to them from Texas Board of Medical Examiners, who were trying to convince them to file complaints against me. So this was shocking to me.
And what is surprising is that they were using the state money, they were using taxpayer's money, to travel long distances, like from Houston to California, to convince our patients, who are in California, to file complaints against me. This was completely irrational.
But nothing else happened at the time until I met, by coincidence, the Vice President of M.D. Anderson Cancer Center ...
Dr. Hickey, who informed me that I will have problems this time with the Texas Board of Medical Examiners.
And obviously the problems began.
And I was called to the Texas Board of Medical Examiners. They began investigating me.
However, there were no complaints from the patients. The patients were happy. We were treating patients who were very advanced, for whom there was no treatment available, and they were getting good results.
So, apparently, there was no justification for such action.
This was a very unpleasant investigation. They were trying to convince me again to stop my research, to stop treating patients.
After about two years of going back-and-forth, and being called to the Board, finally, they proposed to me that I should present to them a number of cases of patients who benefited from my practice. And they informed me that such medical records would be reviewed by expert oncologists, and, if they are satisfied that I am not harming patients, that the patients are benefiting from my activity, then they would leave me in peace. I was very happy with this. I believed that Texas Board would do an objective review of our results, and finally they would leave me alone, because we had amazing results in the treatment of very difficult cancer cases. I supplied to them twice as many medical records, which showed without any doubt great results in the cancer treatment. Incurable forms of cancer completely disappearing, with patients going into complete remission, and patients who were cured and living a normal life after that.

[NARRATOR] In 1986 ...
Dr. Burzynski agreed to present to the Texas State Board of Medical Examiners ...
40 cases of various types of cancer ...
he had successfully treated using Antineoplastons ...
in patients ranging from breast ...
bladder ...
lung, liver ...
brain ...
head and neck ...
and lymphoma.
After submitting these cases to the Medical Board, he didn’t hear back from them, leaving him to assume that the board was satisfied, and would leave him in peace.
However, two years later, the Board came back again, pretended that the cases he submitted were not successful ...
and claimed he was violating a law that didn’t exist ...
which was grounds for the board to cancel, revoke, or suspend his license.

[Dr. STANISLAW BURZYNSKI] It was a shock to me. I believed in justice. I believe in high ethics of the Board. But this was just a lie.

[NARRATOR] The medical board had no case against Burzynski. Which prompted the board to file their first amended complaint in 1990.
Still the board had no case, which prompted them to file a second amended complaint in 1992.
The medical board kept coming back each time with the same argument, practically making xerox copies of their prior claims, changing the titles, and simply resubmitting them.
After about five years of this, 60 of Dr. Burzynski’s patients petitioned the Board to stop harassing their doctor.
The Board then tried to ignore these petitions by attempting to strike them from the record.
Finally in May of 1993 ...
this case went to trial.

[Dr. STANISLAW BURZYNSKI] [May 24, 1993] The tumors will grow, they will lose their vision, they will be paralyzed, and they will die. Because there is nothing in the world which can be used to save these patients' life.

[DEWEY E. HELMCAMP, III, Assistant Attorney General] You intend to continue doing just what you've been doing, until somebody is able to stop you. Is that not true?

[Dr. STANISLAW BURZYNSKI] I'm going to do what the law will allow me to do, Mr. Helmcamp.
I do whatever is necessary to bring my medicines to approval in the United States, and everywhere in the world ...
and bring you to justice for causing the deaths of 200 patients.
And they will come back here to haunt you until you are dead.

[DEWEY E. HELMCAMP, III, Assistant Attorney General] Are you threatening me Dr. Burzynski.

[Dr. STANISLAW BURZYNSKI] I'm not threatening you, but that's what's going to happen in the future.

[DEWEY E. HELMCAMP, III, Assistant Attorney General] Well, I think that's something that remains to be seen.

"Good vs. Evil," by Tara Carreon

[admin]

[JUDGE EARL A. CORBITT, RET., ADMINISTRATIVE LAW JUDGE EMERITUS] I had never heard of Dr. Burzynski. I didn't know anything about him.
I never was quite clear what the Board's problem was.
The Board did not bring any expert witnesses to contest points that were raised by Dr. Burzynski. Now, without an expert witness to render an opinion in certain areas, I can't give any credence to an opinion raised by a layman.
And Dr. Burzynski brought in Dr. Nicholas Patronas.

[NARRATOR] Some of the most dramatic testimony on Dr. Burzynski's behalf ...
came from Dr. Nicholas Patronas ...

[JUDGE EARL A. CORBITT, RET., ADMINISTRATIVE LAW JUDGE EMERITUS] Doctor, why don't you have a seat up here.

[NARRATOR] a Georgetown University expert who was a member of the National Cancer Institute's team ...
that analyzed seven of Dr. Burzynski's cases.

[NICHOLAS PATRONAS, M.D., NATIONAL CANCER INSTITUTE'S CHIEF OF RADIOLOGY] The basic conclusion was that in five of the patients ...
with brain tumors that were fairly large ...
the tumor resolved, disappeared.
It's amazing ...
the fact that they are leaving.
It's impressive, and unbelievable.

[JUDGE EARL A. CORBITT, RET., ADMINISTRATIVE LAW JUDGE EMERITUS] He was quite a witness. He said he had never seen anything like what Dr. Burzynski was able to accomplish with his antineoplastons in brain cancer.
He had one young boy there who had been, he was about 12, at the hearing. Strapping lad. A good-sized boy. But when he was first started on treatment, when he was about four years old -- I think his name was Paul --
he was given up on by his original doctor.

[NARRATOR] When Mary Michaels took the stand ...
on behalf of her son Paul ...
she trained her eyes ...
on the State's attorney.

[MARY MICHAELS] And I have enough to worry about when I go to bed at night about my son and my family ...
I don't need to worry that this treatment is going to be taken away.

[DEWEY E. HELMCAMP, III, Assistant Attorney General] What do you think might happen if --
Nevermind.
Nevermind. I have no other questions.

[JUDGE EARL A. CORBITT, RET., ADMINISTRATIVE LAW JUDGE EMERITUS] For all I know, the kid may still be alive.

[Paul Michaels in 2011 -- 25 years old remains cancer-free]

[NARRATOR] The judge ruled in Dr. Burzynski's favor ...
finding that the Medical Board did not introduce any evidence at the hearing that antineoplastons are not safe and effective, nor did they introduce any competent or substantial evidence at the hearing that antineoplastons are not generally recognized by experts qualified by scientific training and experience to evaluate their safety and effectiveness.
And, as far as the law goes, it does not apply to a licensed physician who manufactures his own medications, and solely uses it on his own patients in the State of Texas.
Now, most would think that at this point, the Texas Medical Board would stop wasting their time, Burzynski’s time, terminal cancer patients' time, and the taxpayers' money, pursuing a case they knew they couldn't win.

[JUDGE EARL A. CORBITT, RET., ADMINISTRATIVE LAW JUDGE EMERITUS] Then they told me after, they were going to re-write my proposal or decision, and take adverse action against Dr. Burzynski ...
and I said I thought that was rather foolish.

[NARRATOR] Well, think again.

[News anchor, 1995] The state of Texas ...
wants Houston doctor ...
Stanislaw Burzynski ...
to stop treating his patients with drugs he produces ...
at his own pharmaceutical plant.
The drugs, called Antineoplastons ...
are non-toxic compounds of proteins and amino acids ...
often lacking in cancer patients.
Even though the state of Texas ...
acknowledges that the drugs may be helping some ...
who are terminally ill ...
the State says the drugs shouldn’t be used.
This is the State Board of Medical Examiners ...
which licenses doctors in Texas.
This is the agency ...
challenging Dr. Burzynski in court.
One judge has already told the Board members ...
that they don’t have a case.

[Dr. STANISLAW BURZYNSKI] All of this nonsense which is going on now should disappear, because they should realize that I am right, okay? They are fighting a losing battle. I am saving human lives. And if they put me out of business, the people will die.

[News anchor, 1995] This is the brain of an eight-year-old boy with a huge tumor most thought would kill him. He used Dr. Burzynski’s drug.

Images of his skull taken six years later show the tumor has almost disappeared.

[News anchor 2, 1995] Dr. Bruce Cohen ...
is the director of neurologic oncology at the prestigious Cleveland Clinic.

[DR. BRUCE COHEN, DIRECTOR OF NEUROLOGIC ONCOLOGY, CLEVELAND CLINIC] The only explanation is that it shrunk ...
because of the therapy Paul has received.

[News anchor 2, 1995] He confirmed Dr. Burzynski’s results on Paul.

[MARY MICHAELS] Seven years we’ve had Paul, and he’s been healthy.
And I owe it to this man.
And there is no way that I’d ever be able to thank him enough ...
for what he’s done for us.

[News anchor, 1995] Today that boy, Paul Michaels ...
and his anxious family ...
sit in the courtroom with other patients.

[NARRATOR] Undeterred by the 1993 ruling, the Texas Medical Board took Dr. Burzynski to a higher, district court.
Of course, this time, they knew that couldn’t raise any issues ...
about whether or not ...
his treatment was effective.

[ABC News anchor #1] The Texas State Board of Medical Examiners, which has fought to suspend Dr. Burzynski’s license because his treatments have never been approved, says quote:
“The efficacy of Antineoplastons in the treatment of human cancers is not of issue in these proceedings.”

[Rick Jaffe, Dr. Burzynski’s attorney] It takes a bureaucrat to come up with that idea, because, a layman, that would really be the question.

[ABC News Anchor 2, 1995] Well, Dr. Burzynski has won his latest round in court. The Medical Examiners order was reversed. But that is not expected to be the end of his trouble with the State of Texas.

[NARRATOR] The Texas Medical Board took this imaginary case ...
all the way to the Texas State Supreme Court ...
where the Judge issued an erroneous probation order against Burzynski, which Burzynski successfully served ...
but, again, leaving the Texas Medical Board completely unsuccessful in their efforts to remove his medical license.
So, if efficacy was not an issue, and Dr. Burzynski wasn’t breaking any laws ...
then why would the Texas Medical Board continue on with this empty pursuit?
Well, it was eventually realized, even by the mainstream press ...
that the Food and Drug Administration had been pressuring the Texas Medical Board to continue trying to take away Dr. Burzynski’s medical license.

[ABC News Anchor] For this story we wanted to talk to the FDA about it’s policies and procedures.
The Agency did agree to talk to us on background where it wouldn't be quoted, but it repeatedly refused our requests for on-camera interviews.

[2. FEDERAL LEVEL: The Food & Drug Administration vs. Stanislaw Burzynski, M.D., Ph.D., and his past, present, and future cancer patients]

[NARRATOR] While they were busy pressuring the Texas State Medical Board to try to revoke Dr. Burzynski’s medical license, they were even busier trying to revoke Dr. Burzynski completely from society, by trying to place him in prison.
The FDA and PhRMA quickly realized that if Dr. Burzynski’s discovery would be given a fair review process ...
not only would chemotherapy and radiation dwindle into obscurity, financially crippling the industry ...
but it would also mean that for the first time in history ...
all of that income would funnel away from PhRMA and into the lap of one single scientist, who holds the exclusive patent rights.
Apparently, the FDA had not ruled out the possibility of this happening one day.
On March 12th, 1976, FDA Bureau of Drugs Director Richard Crout states in “The Cancer Letter”: "When anyone other than large institutions ask permission to conduct clinical trials ...
you want harsh regulations.
Sometimes, we say, it is proper to hinder research.
And once these guidelines were adopted, the FDA would consider itself bound by them."
In 1982, Crout states again, “I never have and never will approve a new drug to an individual, but only to a large pharmaceutical firm with unlimited finances.” And so, the fiercest fight in FDA history began.

[Rick Jaffe, Burzynski’s attorney] [Congressional Subcommittee hearing, July 25, 1995] Dr. Burzynski’s dealings with the FDA commenced in 1983.
At that point, the FDA commenced a civil action to try to close the clinic, and stop all patients from receiving the medicine.

[NARRATOR] Before the judge in this case had announced her ruling ...
the FDA sent her a letter ...
warning her in advance ...
"If this court declines to grant the injunction ...
sought by the government ...
thus permitting continued manufacture ...
and distribution of antineoplastons ...
the government would then be obliged ...
to pursue other less efficient remedies ...
such as actions for seizure" --
also known as raiding his clinic and home --
"and condemnation of the drugs" -- also known as a propaganda campaign --
"or criminal prosecution of individuals" --
also known as throwing Dr. Burzynski in prison. Regardless of these threats from the FDA--

[Rick Jaffe, Burzynski’s attorney] [Congressional Subcommittee hearing, July 25, 1995] The judge in the case basically said that he can treat anybody he wants in Texas, but he can’t ship his medicine in interstate commerce. The FDA viewed that as a failure, and told Dr. Burzynski’s attorneys at the time that they have other ways to get him. Let’s talk about the other ways. In 1985, the FDA convened a grand jury to hear evidence to try to indict Dr. Burzynski. In connection with that, they had a raid of his clinic, where they seized 200,000 pieces of paper, including all of his medical records of all patients. It’s a little difficult to practice medicine when you don’t have medical records.

[Dr. STANISLAW BURZYNSKI] Obviously, they came armed, and they confiscated our medical records. And it took us about 12 years, or 14 years, to recover these medical records. In the meantime, we were permitted to make copies of these medical records in their office. But it was also the neglect of human well-being, because we were treating very sick people. They took medical records, and we needed these medical records to really fight for the lives of these patients. But they took this away. They didn’t care for these patients. The patients could die. They were not important.

[Rick Jaffe, Burzynski’s attorney] [Congressional Subcommittee hearing, July 25, 1995] They presented the evidence to the grand jury, no indictment. 1986, they come back, seize another 100,000 documents, no indictment. 1990, another grand jury, either the second or the third, they present more documents, Dr. Burzynski testifies extensively before the grand jury, no indictment. 1991 to 1993, the FDA investigates Dr. Burzynski. We don’t know if evidence was presented to another grand jury.
1994, another grand jury, no indictment. 1995, another grand jury. This grand jury started in March of this year.
on March 25th, I believe, it was Dr. Burzynski, along with a few of his patients ...
appeared on CBS Show This Morning.

[Harry Smith, CBS This Morning, 3/25/95] Let me play Devil’s advocate.
Here you all -- very desperate folk -- had undergone some cancer treatment, correct?

[Mary Jo Siegel] No, I had no treatment.

[Harry Smith, CBS This Morning, 3/25/95] None at all for you? Then let me go after these guys who had undergone some treatment. Could it not have been that the treatment that you received, prior to Dr. Burzynski’s treatment, was what in fact really cured you?

[Neal Dublinsky] Well, I’ll jump on that. No way.
Because the recurrence I had was in a brand new spot, that had not been involved before. So if all the punishment that I went through for the year went out of my system, and after it went out of my system all of a sudden a new tumor comes in, how could that first treatment have helped the subsequent tumor?

[Rick Jaffe, Burzynski’s attorney] [Congressional Subcommittee hearing, July 25, 1995] LATER
THAT ...
DAY ...
THE ...
FDA ...
CAME ...
IN ANOTHER RAID.
More patient documents, more subpoenas.

[Harry Smith, CBS This Morning, 3/28/95] We were flooded with calls last Friday with people wanting to know how to get a hold of you.
They are going to see this story this morning, see that you’ve been raided by the FDA, and they are going to want to know if you are for real ...
or if the concerns of the FDA may have something to do with your treatments ...
and the viability of your treatments.

[Rick Jaffe, Burzynski’s attorney] Well, I don't think -- let me jump in here -- I don’t think there’s really an issue, as I mentioned, regarding the safety of the drug ...
and the FDA isn’t contending at this point that the drug doesn’t work. The only issue is that, according to the FDA, it has not been proven by controlled clinical trials. So at least, in terms of safety, the FDA isn’t saying that it’s not safe. And the FDA isn’t even saying that it doesn’t work. Alright?
Right now they’re just contesting, or apparently they’re contesting, whether Dr. Burzynski himself has been shipping the medicine out of state, which in some respects is quite ridiculous, since he has approval to ship the medicine out of state to various cancer institutions around the country.
He ships it out of the country to various countries, because it’s being used in other places. And he ships it to individuals who have been granted permission by the FDA to receive the medicine under what is called a “compassionate use INDs" (investigational new drug).

[Rick Jaffe, Burzynski’s attorney] [Congressional Subcommittee hearing, July 25, 1995] May, June, and July: More witnesses testify before the grand jury, more documents. So we’ve had now four, five, or six grand juries. Let me talk about the subpoena practices. Most recently, the FDA has now subpoenaed the medical records of every patient who has gone on TV and told their story about Dr. Burzynski. We’ll let the committee judge what they think of that. We talk about dissemination of false information by the FDA: In 1985, the FDA tells anyone who calls inquiring about Dr. Burzynski that he’s being criminally investigated. When the judge in the case found out about that, he issued a cease and desist and a strong reprimand against that.
The FDA now has refined this tactic. Instead of waiting for people to call up the FDA, what they’ve done is subpoena all the records from Dr. Burzynski about his business associates, and all the researchers around the world, and there are many of them who are researching Antineoplaston his therapy. Now what they are doing is systematically contacting everyone who does business with him, or who may do business with him, and telling about the grand jury investigations and subpoenaing of documents. I believe that they are doing this in order to make it more difficult for him to do business.
I’d like the following questions to be asked to the FDA: How much money have they spent in the last ten years to try to put Dr. Burzynski out of business? How many documents can they subpoena? And how many more grand juries does he have to go to? And why can’t patients, who have advanced cancer, seek the medical treatment of their choice?

[NARRATOR] Upon the commencement of the FDA’s 1995 grand jury against Dr. Burzynski ...
an Oversight and Investigations Subcommittee was organized by Congressman Joe Barton, in an attempt to intervene in the FDA’s relentless harassment of Dr. Burzynski and his patients.

[Dr. David A. Kessler Commissioner, The Food and Drug Administration, Oversight and Investigations Subcommittee hearings November 15, 1995]

[Hon. Joe Barton] In my opinion, you have every right to use the investigative authority, and the judicial resources of the federal government through the Justice Department, to convene a grand jury. That’s very appropriate the first time, perhaps even the second time. It becomes questionable the third time, the fourth time, and the fifth time.
It is not, I think, an unlogical conclusion, to think that the FDA has a vendetta against Dr. Burzynski, or wants to retaliate for some reason. Now that’s my opinion.
How many grand jury investigations have to occur that result in no finding of fault before you, as commissioner of the FDA, would encourage those within your organization to cease and desist?

[Dr. David Kessler] Mr. Chairman, how do you know that there were no findings of fault that were returned from that grand jury?

[Hon. Joe Barton] There have been no indictments returned.

[Dr. David Kessler] Mr. Chairman, I ask counsel to comment, but I don’t think those are the same, as a matter of law those are the same things.

[Hon. Joe Barton] I’m baffled by the splitting of hairs here but...

[Committee member] I am just trying to understand ...
the exchange between the witness and the Chairman.
What I understood the Chairman to say is that there have been four grand juries convened?

[Hon. Joe Barton] At least four.

[Committee member] I just am left then, with rather strong inference, that if you convene four separate grand juries and there is no indictment returned ...
notwithstanding that prosecutors tell us always that it’s possible to indict a ham sandwich, that probably there’s not much there.

[NARRATOR] Dozens of Dr. Burzynski’s patients, who had traveled to Washington D.C. from all corners of the United States, stood up and expressed their outrage with the FDA and Commissioner David Kessler.

[Woman Patient #1] The FDA has made a list, and decided who can live and who will die. I guess I didn’t make that list.

[Woman Patient #2] I have had no chemotherapy. I have had no radiation. I chose Dr. Burzynski instead after a lot of research and a lot of searching. I’ve been in remission since 1989. Dr. Kessler, I’m not a statistic.

[Man Patient #3] We’re frustrated. There are rights, Constitutional rights have been violated.
This has got to end. My children are asking me, “Daddy, what does the future hold?”
My one daughter wrote a letter to the President of this country and said, “Please don’t pull the plug on my daddy.” And that just broke my heart, and broke my wife’s heart.

[Man Patient #3’s wife] My husband is a walking miracle. Sixteen months ago the doctors told us there is nothing else they can do, and they told us to enjoy what little life he had left. Look at him. He biked 32 miles after being on Dr. Burzynski’s treatment for two months.
And they’re saying we can’t have it?!

[Woman Patient #4] I have a report from my family physician which tells how well I am doing. My tumors are leaving my body, and my condition is improving every day.
Now the FDA is saying to me, “No, your doctor is a criminal. He should be put in jail, and he needs to be shut down.” This, is criminal!!

[Woman Patient #5] I want the FDA to get out of our lives and stay out of our doctor-patient relationship.

[Man Patient #6] What the classical conventional medicine had to do for me was there: nothing. For me, the next thing was the minister.
I did not want to undergo chemotherapy, which I had a new name for: “Kill ‘em therapy” --
or any type of radiation.
I was extremely lucky I found Dr. Burzynski.
And I don’t want the FDA to take this right from me. I came eighteen years ago from Communist Romania, and the tyrannous dictator Ceauscescu, never stopped a doctor from treating anybody. How can we have something like this in United States?

[NARRATOR] Barely a week after these hearings, on November 20th, 1995, Dr. Stanislaw Burzynski was indicted.

[On November 20, 1995 Stanislaw Burzynski, M.D., Ph.D. was indicted.
Burzynski was charged with 75 counts of violating federal law and fraud.]

[Burzynski was charged with 75 counts of violating federal law, and fraud.]

If convicted, Burzynski would face a maximum of 290 years in a federal prison, and $18.5 million dollars in fines. Not to mention what would happen to his patients.

[If convicted, Burzynski would face a maximum of 290 years in a federal prison, and $18,500,000 in fines.]

["Hard Copy” News Anchor, 1996] He is their last chance for life.
But now the federal government is issuing a death sentence for the patients of this cancer doctor.

[“ABC” News Anchor] On February 9th, Houston Federal Court Judge Sim Lake ruled Dr. Burzynski’s treatments have been quote “illegal under Texas and Federal Law since 1984,” and he ordered them stopped on all but a handful of patients. Then he put a stay on his own order, a stay of execution.

[Dr. STANISLAW BURZYNSKI] I believe that most of these 300 people will die within a short period of time if the treatment is stopped.

[NARRATOR] In 1996, not only did scores ...
of Dr. Burzynski’s patients ...
return to Washington D.C. to protest his indictment ...
but many of them testified again before another Congressional Hearing headed by Congressman Joe Barton.

[Hon. Joe Barton] [Congressional Subcommittee Hearing 2/29/96] Our first witness is Mariann Kunnari, is that correct?

[Mariann Kunnari] Yes, that’s correct.

[Hon. Joe Barton] From Aurora, Minnesota.

[Mariann Kunnari] This is Dustin Kunnari and he is on Dr. Burzynski’s antineoplaston treatment.
This is my husband, Jack Kunnari.
Now, in February of 1994, our lives were drastically changed. My son, Dustin, was only 2-1/2 years old at the time. He was diagnosed with a brain tumor the size of a golf ball. The surgeon removed 75% of his tumor, and the remaining 25% was diagnosed from a biopsy as a malignant, very aggressive, medulloblastoma brain tumor, one of the most deadly forms of brain cancer.
The doctors told us Dustin had only a few months to live.
The first treatment offered us was radiation. But the radiation doctor told us that at his young age, Dustin would become a vegetable, and it would only extend his life for maybe a few months. The next doctor wanted us to enroll Dustin in an experimental chemotherapy, which was highly toxic.
The side effects would include hearing loss, kidney and liver damage, bladder, stunted growth and a possible leukemia. One question I’d like to ask is: would you do that to your child? We weighed the harm these experimental drugs would cause against the fact that they would not cure Dustin, and decided not to subject him to these drastic measures.
But our oncologists told us that their opinion took precedence over us as parents. This put added stress to the already stressful situation we were in.
In April of 1994, we visited Dr. Stanislaw Burzynski in Houston. Dr. Burzynski made us no promises, but said that he often had good results with brain tumors, at worst it would not hurt Dustin, and it offered the best hope in a longer quality of life.
An MRI six weeks after we started Dr. Burzynski’s treatment revealed no tumor. We were very overjoyed.
Dustin continued Antineoplaston therapy, and one year later a tumor 1" x 1" in size was found on the MRI. That would be in April of 1995. Dr. Burzynski immediately raised Dustin’s dose of Antineoplastons. There were still no harsh side-effects at all. The next MRI in September of 1995 revealed that the tumor had almost disappeared again. To this day it has not reappeared.
If you look at Dustin right now ...
he’s a happy, healthy 4-year-old, who has outlived his prognosis.
There is no a traditional treatment ...
that would have kept him alive ...
with such good quality of life.
FDA Commissioner David Kessler loves to grab headlines as a man who loves children so much he wants to protect them from the ravages of smoking.
If Dr. Kessler loves children so much, why have he and his agencies been trying so hard to cut off my son’s last hope for life?
Without this treatment, my son will die.

[NARRATOR] This is a photo of Dustin Kunnari at four years old in 1996. This is a photo of Dustin Kunnari at 18 years old in 2009, and his brain cancer never returned.

[admin]

[In 1996, due to Congressional and public pressure,
the FDA agreed to accept all of Burzynski's patients into a series of FDA-approved Phase II clinical trials.
Which opened the door to initiate a total of 72 different clinical trials using Antineoplastons.]

[Dr. STANISLAW BURZYNSKI] In 1996, because of pressure from the politicians and American opinion, the FDA agreed to accept all of the patients whom we had at the time into a program of Phase II clinical trials. Basically, we filed and received permission from the FDA, to proceed with 72 different Phase II clinical trials, which covered practically any type of cancer. This was such tremendous work, that basically it was necessary for me to work almost around-the-clock, with six secretaries who were typing different protocols. And later I learned that the FDA created a special task force to be able to review these protocols.
We have soft tissue sarcoma -- there is a special protocol for that. You have breast cancer -- a special protocol. For lung cancer -- a few different protocols. For brain tumors -- about over twenty different protocols for different type of brain tumors.

[NARRATOR] So, just a year before his trial facing life in prison, the Food and Drug Administration had finally authorized the very thing that Dr. Burzynski and his patients have ever wanted.
Even still, the FDA would not back down in making sure Burzynski’s trial moved forward.
Federal prosecutors concede that a cancer doctor they will put on trial here in January, for using an innovative but unapproved drug, has been saving lives.
The prosecution marks the first time the FDA has tried to jail a scientist for using a drug on which he is conducting FDA-authorized clinical trials.
In a pre-trial motion, Assistant U.S. Attorney Mike Clark objected to a defense request for the jury to visit the chemical plant where Dr. Burzynski manufactures antineoplaston.
The jury visit request is
"a thinly veiled effort to expose the jury to the specter of Dr. Burzynski in his act of saving lives.”
Whether antineoplaston does or does not work is not an issue ...
and the jury should not be asked to decide the question.
He added that if the issue comes up at trial, it would be an irrelevant, emotional, prejudicial, and misleading concern.

[Charles Zewe, CNN Anchor, Jan. 1997] The issue of whether Antineoplastons work may not even come up during the trial. The judge says that’s not relevant. But the defense contends that’s exactly the point. That what was done in developing the drug and administering it, was done to save lives.

[NARRATOR] This trial cost the American taxpayers $60 million dollars, while costing Dr. Burzynski over $2.2 million.
$700,000 dollars of Burzynski’s legal defense was raised primarily by Dr. Julian Whitaker ...
through his newsletter “Health and Healing”.
After Dr. Whitaker wrote of the plight and injustice being done to Dr. Burzynski, his readers sent in close to 18,000 checks in small donations for Burzynski’s legal defense.

[Charles Zewe, CNN Anchor, Jan. 1997] The trial is expected to last about two months.
The jury will then decide whether Burzynski is a fraud, or a medical pioneer.

[NARRATOR] On March 4th, 1997 ...
due to a deadlocked jury, the judge declared a mistrial.
And, after saying the government had not presented sufficient evidence ...
he ordered that Dr. Burzynski be acquitted of nearly half of the 75 counts.

[Interview of jurors, March 4, 1997] You voted to acquit?

[Juror #1] To acquit, absolutely.

[Juror #2] Not guilty.

[Juror #3] Not guilty.

[Juror #4] I voted for acquittal.

[Juror #5] I voted my mind, and my heart.

[Juror #4] I do not believe that Dr. Burzynski is a criminal.

[Juror #5] And I had voted to acquit.

[NARRATOR] But the FDA was still not backing down. They took Dr. Burzynski to trial again.

[The FDA took Burzynski to trial, again.]

Though, after apparently accepting the absurdity of their case, on May 19th the FDA suddenly dropped 40 of the 41 remaining charges.
The FDA’s facade, and trying to convince the world that Burzynski was a criminal, was completely unraveling. Even the jurors who voted not guilty in the first case, took time off of work to join the patients’ protest in front of the courthouse during the second case.

[Interview of Jurors, March 19, 1997]

[Juror #6] I am appalled at the Food and Drug Administration and their actions.

[Juror #7] We are here today, basically, to protest the witchhunt that’s going on by the FDA.

[Juror #8] We have to stick together and really support these patients that are suffering, not only healthwise, but having to come down here to make a stand against the FDA.

[Juror #9] Please don’t waste my money abusing the system to make sure that you maintain your power.

[NARRATOR] The jury spent about three hours deliberating this house of cards ...
leaving Burzynski acquitted of the final charge.

[Rick Jaffe, Burzynski’s attorney] [March 19, 1997] Every one of Dr. Burzynski’s patients now, every future Burzynski patient ...
is and will be on a clinical trial.


[Dr. STANISLAW BURZYNSKI] There were many patients who would like to testify on our behalf, and convince the jury and the judge that without the treatment, they will die. But the judge did not admit any statements which could show that the treatment is effective.
The judge did not allow the jury to visit our facility where we produce medicine. They were trying to keep it away from the jury.
If this information would be presented to the jurors, then this trial would be finished very quickly. And that’s what the jurors told us, because after the trial we talked to the jurors. And they were shocked that such information about the treatment which is saving the life of patients was not presented to them.
And I was sick listening to the lies of prosecutors from U.S. Attorneys. It was not necessary for them to do it. They could tell the truth. They represented the biggest power, but they still were doing this all the time.
So they were trying to do it a sneaky way. And that’s what is horrible, okay? That’s what should be exposed. Because I think the United States deserves better.

[3. THE NATIONAL CANCER INSTITUTE and PhRMA vs. Stanislaw Burzynski, M.D., Ph.D., and all past, present, and future cancer patients]

[While all of this was taking place ...]

[NARRATOR] While all of this was taking place ...
Burzynski knew that the easiest way to keep the government from putting him out of business, or in prison, was to partner with an established pharmaceutical company.
An interest was shown from Japanese pharmaceutical company “Chugai” ...
and the Italian pharmaceutical company “Sigma-Tau.”
But both deals eventually evaporated, likely due to the “rapport” developed so far between Antineoplastons and the FDA.
Being an “issue, indeed” ...
and were unable to verify ...
the likelihood that they could openly and effectively ...
work with the FDA.
Then, by 1990 ...
it seemed that Burzynski’s luck had finally changed.
Burzynski had apparently treated the sister-in-law ...
of the Chairman and CEO ...
of Elan Pharmaceuticals.
Elan enthusiastically drafted a letter of intent ...
stating they would aggressively pursue the filing of necessary protocols ...
with the Food and Drug Administration ...
for approval and marketing of Antineoplastons as quickly as possible.
They soon negotiated financing ...
licensing agreements, and royalties.
In the midst of closing this deal with Elan, more good news emerged. Dr. Dvorit Samid, a scientist and medical professor from Maryland, who Burzynski had hired to further study Antineoplastons ...
managed to present her work at an oncology symposium in Switzerland ...
which landed her and Antineoplastons a cover story in a 1990 issue of “Oncology News”.

[Dr. STANISLAW BURZYNSKI] In 1989, we retained Dr. Dvorit Samid as our consultant. Dr. Samid, at that time, worked at Uniformed Services Medical School in Baltimore, and later she moved to the National Cancer Institute. She did a lot of work with Antineoplaston ingredients. Unfortunately, when the pharmaceutical company entered the picture, such as Elan Pharmaceutical, our consultant, Dr. Samid, became too close. She really became consultant for Elan Pharmaceutical, and she was working with Elan from this time.

[NARRATOR] And suddenly, Elan Pharmaceuticals terminated their licensing agreement, stating ...
"Elan has significant doubt ...
as to whether the active substances ...
comprising of Antineoplastons have patent protection ...
thereby rendering an agreement meaningless.

[Dr. STANISLAW BURZYNSKI] Antineoplastons are not just one chemical. So we have different ingredients in Antineoplastons, okay?
One of these ingredients was known before. We discovered that this was metabolite of Antineoplaston, and it was known, and was available before, okay? So when we patented our invention, our lawyers told us, “Look, you can’t patent this particular ingredient, because it was known before, okay? So let’s list it in your patent, but don’t patent this because you will never get a patent for that.”
But this is the least important ingredient of Antineoplastons.

[NARRATOR] While this was an odd turn of events, more good news continued to pour in.
It was in October 1991 when Dr. Nicholas Patronas led the National Cancer Institute on their site visit ...
the very same site visit Dr. Patronas would later base his testimony when defending Burzynski against the Texas Medical Board.
This site visit not only confirmed that Antineoplastons were curing ...
what was previously considered incurable brain cancer ...
but it garnered their interest in conducting a confirmatory trial ...
under Division of Cancer Treatment sponsorship ...
at the National Cancer Institute.
These trials involved most of their top experts, including Dr. Michael Friedman, the Associate Director of the Cancer Therapy Evaluation Program.
In a memo addressed to his director, Dr. Friedman wrote ...
"I thought you would be interested in this.
Antineoplastons deserve a closer look.
It turns out that the agents ...
are well-defined, pure chemical entities.
The human brain tumor responses ...
are real."
The National Cancer Institute's “Decision Network” then convened ...
and gave the green light to conduct government-sponsored clinical trials ...
of Antineoplastons.

[Dr. STANISLAW BURZYNSKI] Initially, everybody was very excited about it. Everybody wanted to proceed. The people who reviewed our results -- the experts from the NCI -- they did a very good job. They were critical, of course, but they were also highly complementary for the way we treated patients and the results we got, okay? It looked like everything should open and move forward.
Suddenly everything came to a stop. And then we found that a few months later Elan received permission to do clinical trials with this particular ingredient.
Ours was pushed back for something like four years, and then Elan was allowed to proceed with this one suddenly.

[NARRATOR] When Elan terminated their business deal with Burzynski, they went behind his back ...
recruited Dr. Dvorit Samid ...
and partnered with the National Cancer Institute ...
where Dr. Samid soon became a Section Chief.
Elan then co-sponsored laboratory research and clinical trials testing only this single ingredient, called “Phenylacetate," the same chemical that Burzynski was advised he couldn’t patent, and had already proven to be quite limited against cancer as a single substance as far back as 1980.

[Dr. STANISLAW BURZYNSKI] After the treatment in a small number of patients, we found that the activity was quite limited. That’s why I decided to abandon phenylacetate, and we use the other Antineoplastons. One of them contains phenylacetate as the second ingredient.
Phenylacetate alone has very small activity. It’s not very effective.

[LI-CHUAN CHEN, PH.D., NATIONAL CANCER INSTITUTE SCIENTIST 1991-1997] In 1994, I started working for Dvorit Samid.
She didn't let me know that one of those compounds is from Dr. Burzynski.
You know, she just said, "Phenylacetate" ...
and show me all the published papers about phenylacetate ...
and its analogs, and their anti-cancer activity.
It was quite amazing in the lab ...
because if you find a compound that has anti-cancer activity ...
and then you find a bunch of analogs ...
it's like you stumbling upon a pile of gold.
So people would think and say, you know ...
"patents, patents, patents" ...
you know, that sort of thing.
Dvorit, under her leadership ...
we found a lot of biological activities in these compounds.
So it would have anti-cancer activity.
So the scientists at Johns Hopkins tried to patent these compounds ...
but of course, Dvorit was working with ...
Elan Pharmaceutical company at that time ...
so those guys at Johns Hopkins didn't have any chance of ...
patenting those compounds.
But it's interesting that she would complain in the lab ...
and saying that these guys tried to go behind her back ...
and patent these compounds.

[NARRATOR] While Burzynski was facing continuous harassment from State and Federal agencies ...
the earliest phenylacetate studies were published in April of 1992, authored by Dvorit Samid ...
hosted by the National Cancer Institute. Burzynski sat in awe as he witnessed the National Cancer Institute recruit one of his researchers ...
push his research aside ...
and begin to test phenylacetate without him, reporting:
"Phenylacetate is both effective in inducing tumor cell maturation ...
and free of cytotoxic and carcinogenic effects ...
a combination that warrants attention to it’s potential use in cancer intervention."

[LI-CHUAN CHEN, PH.D., NATIONAL CANCER INSTITUTE SCIENTIST 1991-1997] In 1995, in the lab, I was still with Dvorit ...
but I smelled fishy ...
something is not right.
The first paper Dvorit published about phenylacetate ...
if you look at the methodology section ...
there's a "BRI" abbreviation.
She got materials from the Burzynski Research Institute, Houston, Texas.
But it didn't say, "Burzynski Research Institute."
For us, as scientists ...
it's a funny practice.

[NARRATOR] Burzynski's name failed to appear in the Acknowledgments, or any of the References listed in this report.
Burzynski knew these tests would fail ...
since he had already proven this ...
in his own laboratory 12 years before.
Abandoned by the National Cancer Institute ...
he sat powerless on the sidelines ...
as the attempted hijacking of his discovery unfolded before his eyes, ending in the hideous train wreck he warned them it would.
The National Cancer Institute, Elan, and Dr. Samid spent over four years and tens of millions of dollars testing phenylacetate.

[LI-CHUAN CHEN, PH.D., NATIONAL CANCER INSTITUTE SCIENTIST 1991-1997] Phenylacetate, really, by itself, has very little clinical effect.

[Dr. STANISLAW BURZYNSKI] The SEI, or Elan, could not use the other ingredients of antineoplaston because they were covered by the patents owned by me.
They were trying to commercialize this, but without the other ingredients, they couldn't do much with this.
This needed to be given in conjunction with the others.

[NARRATOR] While coming to terms with this reality, the National Cancer Institute decided to honor the government-sponsored clinical trials of Antineoplastons they had initially promised Burzynski in 1991.

[The NCI decided to honor the government-sponsored clinical trials of Antineoplastons they had initially promised Burzynski in 1991.]

From the moment this dialogue was reopened, the National Cancer Institute proposed altering the treatment protocols that Burzynski had spent 20 years perfecting.

[The NCI proposed altering the treatment protocols that Burzynski had spent 20 years perfecting.]

Burzynski told them that until they agreed to a protocol that he has confidence in, he was not going to provide the National Cancer Institute with any Antineoplastons.

[Until they agree to a protocol that he has confidence in, he was not going to provide the NCI with any Antineoplastons.]

Dr. Michael Friedman told Burzynski: "In response to your correspondence ...
one last time, we will revise the protocol ...
with regard to dose and schedule in compliance.
However, if you are unable or unwilling ...
to provide the antineoplastons in the near future ...
we will pursue alternative sources ...
to procure the drug or its active components ...
and will proceed."
Burzynski responded: "I appreciate very much ...
that you have finally decided to follow ...
my recommendation regarding dosage.
But, your final statements ...
that you are ready to proceed ...
with the treatment with Antineoplastons ...
without our participation ...
caught me by surprise.
It is hard to imagine that a Federal employee ...
would consider patent infringement."
Placing these ominous threats from Michael Friedman aside, they finally managed to agree on a protocol.
The protocol was simple: Patients with tumors larger than 5 cm ...
more than one tumor ...
or with metastases are excluded.
After everything was approved, and Burzynski released his medicine, a full year passes, in which time over 15,000 Americans have been diagnosed with the types of brain cancer this trial was focusing on.
Yet, America's National Cancer Institute was somehow having difficulties in accruing patients. So, they used this as an excuse to go behind Burzynski's back again, and take it upon themselves to drastically alter the protocols.
"Dr. Friedman, it has been brought to my attention ...
that the protocol has been amended ...
to accept patients with tumors ...
measuring over 5 cm. ...
multiple tumors, or with metastases.
I am outraged that without my knowledge ...
Memorial Sloan-Kettering Cancer Center ...
with NCI's permission ...
changed the ...
protocol.
Treatment of patients with these conditions ...
will require a different protocol ...
with a different schedule ...
and different dosages.
I hereby request that the amendments ...
be canceled immediately ...
and the original protocol ...
be used as promised."
The National Cancer Institute responds: "Sorry, but the amendments have been approved."
Burzynski fires back: "Let me make perfectly clear that ...
as the discoverer and developer of antineoplastons ...
and the individual ...
with nearly 20 years ...
clinical experience using them ...
it is my professional opinion ...
that the drugs will not produce ...
substantial benefit ...
in such advanced patients.
As I have repeatedly informed you ...
The protocol that we are currently using ...
for such advanced tumors ...
requires doses three times greater than that currently being used."

[ABC News Anchor] These trials have been conducted ...
at the Mayo Clinic in Minnesota ...
and the Sloan-Kettering Hospital in New York. Currently there are only 8 patients enrolled.

[DR. MICHAEL FRIEDMAN, ASSOCIATE DIRECTOR, CANCER THERAPY EVALUATION PROGRAM] I am very dissatisfied with that because our desire is to achieve the proper enrollment in as quickly a manner as we can, in order to really test this hypothesis.

[ABC News Anchor] Friedman blamed Burzynski for this slow motion, saying Burzynski restricted admissions for the trials too stringently.
To speed things up, admission standards for the trials ...
have been lowered to bring in patients in worse physical condition. This over Dr. Burzynski's strenuous objections.

[Dr. STANISLAW BURZYNSKI] We got the idea that the main interest is to let these patients die rapidly, and make sure that the treatment will never work.

[ABC News Anchor] Dr. Burzynski has threatened legal action ...
to halt these new admissions, and NCI has suspended recruiting ...
leaving the trials with just those scientifically unsatisfactory 8 patients.
Meanwhile, both the FDA and the Texas Medical Board are still trying to stop Burzynski.

[NARRATOR] On May 8, 1995, less than two weeks before this broadcast, the National Cancer Institute issued an internal memo:
"To all of those involved in the antineoplaston trials. For the Record.
The Clinical Trials Monitoring Service (CTMS) ...
has been instructed ...
not to send any antineoplastons clinical trial data to Dr. Burzynski ...
The Burzynski Research Institute ...
or anyone inquiring about the antineoplastons clinical trials.
Any inquiries that may be related to the trials or Dr. Burzynski, are to be referred to the Associate Director, CTEP ...
Dr. Michael Friedman."
Friedman then taunts Burzynski: "I must convey my deep pessimism.
We are in no way ...
obligated to obtain your consent.
Your insistence on dictating the manner ...
in which we conduct or review these clinical trials ...
is both presumptuous ...
and inappropriate.
The future of these trials ...
rests entirely with the NCI ...
since our primary obligation ...
is to the American public."
Burzynski responds: "Your letter of June 6th conveys pessimism?
My letter conveys outrage.
Patients were admitted against admission criteria.
Their treatment was discontinued ...
and their lives ...
were jeopardized for frivolous reasons.
In spite of your promise ...
we never received any detailed data ...
on these patients.
There must be a reason ...
why you are afraid to provide us with complete copies of medical records."
Well, there was a very good reason why Dr. Michael Friedman was afraid to provide Burzynski with complete copies of these patient's medical records:

[Dr. STANISLAW BURZYNSKI] It took us at least half-a-year before we forced NCI to release some of this information to us. And then we found that they severely violated the protocol. They did not comply at all with the protocol.

[Patients were forced to stop the treatment because of massive fluid retention.]

On top of that, patients were forced to stop the treatment of Antineoplastons because of massive fluid retention. And this is something which we don’t see with Antineoplastons.
The typical side-effect of Antineoplastons is dehydration, which means elimination of the fluids. The patients are losing a lot of fluid, to the point where they have to drink a lot of extra fluid. We don’t see increased fluid retention. I was curious why this could happen. I knew that the patients were receiving a lot of intravenous fluid, but then we learned that perhaps the fluid which they were receiving were not Antineoplastons.

[NARRATOR] In October of 1995, the National Cancer Institute’s “Cancer Information Service” issued a public statement for anyone inquiring about their clinical trials of Antineoplastons.
In it they stated, "Because these studies were closed prior to completion, no conclusions can be made about the effectiveness or toxicity of Antineoplastons." To their credit, and according to the scientific standards set by the National Cancer Institute, this was indeed the truth.
However, four years after these trials were closed ...
and two years after Burzynski defeated the FDA and won his freedom, the National Cancer Institute just couldn’t leave well enough alone ...
and decided to vindictively publish these scientifically invalid Antineoplaston trials in the peer-reviewed medical literature.
In it, they described how nine patients were treated, and no patient demonstrated tumor regression.
However, whoever was responsible for publishing this report was apparently careless enough to also include the Antineoplaston concentrations detected in the blood of the nine patients during treatment.

[Dr. STANISLAW BURZYNSKI] We compared this to the data which we have in our studies. We found that they were severely diluting the medicine, and this was why the patient had fluid overload.
Antineoplaston AS2-1 consists of two ingredients, which is called Phenylacetate, and Phenylacetlglutamine.

[Antineoplaston AS2-1: Phenylacetate Phenylacetylglutamine]

And about 2.7 times lower level of Phenylacetate in patient’s blood compared to what we see in our patients who receive successful treatment.
Phenylacetlglutamine, there is about 36 times lower level in patient’s blood compared to what we see in our patients receiving the right dosage of Antineoplastons.
And the concentrations of Phenylacetylisoglutamine, one of the main ingredients of Antineoplaston A10 ...

[Antineoplaston A10: Phenylacetylisoglutamine]

were close to 170 times lower than what we see in the treatment of patients with Antineoplastons.
And that’s what we found from the patients' husbands or the patients themselves. That’s what they were doing. So this was horrible, okay? This was like a criminal act, okay? They should be prosecuted for that, okay?
Because obviously, they knew what they were doing, and they knew that these patients have really no chance to respond to any treatment, they are going to die, okay? And that’s what happened. After we realized what they do, we decided to force them to stop clinical trials. And since then, obviously, National Cancer Institute hates us, okay? They do whatever they can to not cooperate with us anymore.

[LI-CHUAN CHEN, PH.D., NATIONAL CANCER INSTITUTE SCIENTIST 1991-1997] In the past ...
when NCI ...
or its assigned entity, conducting an alternative cancer therapies, they always alter the protocol and let it fail ...
to discredit the therapy.
But this time, the pharmacokinetic data shows that they didn't do it right.
And most scientists will not look at it carefully.
Because papa is telling you something, and you don't question him.

[SIDE B: The United States Government vs. Stanislaw Burzynski, MD, PhD and all past, present, and future cancer patients]

[NARRATOR] Most of us would assume that with any story such as this, surely there’s another side to it. Our story is no exception.
After the National Cancer Institute intentionally violated all protocols of their own Antineoplaston trials, and after all state and federal agencies had failed in their 14-year campaign to remove Burzynski from society, after all of the dust settled, a profound truth began to emerge.
It was October 4th, 1991, that America’s National Cancer Institute hosted their site visit to Burzynski’s clinic ...
and verified for themselves that anti-tumor activity was documented ...
by the use of Antineoplastons.
Seventeen days later, on October 21st, 1991 ...
The United States of America ...
as represented by The Department of Health and Human Services, and Dr. Dvorit Samid ...
filed a patent for Antineoplastons AS2-1.
They even had the audacity to include Burzynski as a reference.
“The invention described herein may be manufactured, used, and licensed by or for the government, for governmental purposes...” At the time, Burzynski had no idea this had happened, but did have his suspicions when they began to openly test Phenylacetate without him.
And the National Cancer Institute knew it.
In an April 1993 NCI memo, distributed to those involved with Burzynski ...
they state their concerns:
"Political issues are a real concern.
Congressman Bedell is concerned ...
we are taking the Antineoplastons away from Burzynski.
Burzynski has patents on Antineoplastons.
Since phenylacetic acid, or Phenylacetate, may be the active component in Antineoplastons ...
our involvement has become an issue."
Five months later, the United States of America, and Dr. Dvorit Samid ...
file their second extended patent on Antineoplastons.
And guess who else was in it? [Elan Pharmaceutical Corporation].
In March of the following year ...
America files its most extensive ...
updated Antineoplaston patent to date, spanning 111 pages. [Patent #5,605,930]
Seven months later, they file a fourth one. [Patent #5,852,056]
June 6, 1995 ...
the United States government has a field day filing their fifth [US Patent #5,654,333] ...
sixth [US Patent #5661179] ...
seventh [US Patent #5,635,533] ...
and eighth [US Patent #5,710,178] extended patents on Antineoplastons.
The following day, America files it’s ninth [US Patent #5,843,994] ...
tenth [US Patent #5,877,213] ...
and eleventh [US Patent #5,881,124] extended Antineoplaston patent.
And a couple of months after the eleventh patent was filed ...
Dr. Michael Friedman leaves his position at the National Cancer Institute, and becomes Deputy Commissioner of Operations for the Food and Drug Administration ...
working directly under Dr. David Kessler.
And by November of that year, after a decade of failed grand juries, the United States of America’s Food and Drug Administration finally manages to indict Dr. Burzynski.
One month into America’s criminal trial against Burzynski ...
America’s first patent on Antineoplaston AS2-1 is approved.
A month after America fails in their second trial against Burzynski ...
their second and third Antineoplaston patents are approved.
Over the course of the next three years ...
the United States Patent Office ...
approves all 11 ...
copy-cat patents ...
on Antineoplastons ...
AS2-1.

[STANISLAW BURZYNSKI] And as we know, all of this was being done based on the fact that the United States, which is the National Institute of Health, together with pharmaceutical company, which is Elan Pharmaceuticals, was trying simply to steal my invention. That’s what they wanted, okay? It’s not that we had successful visit from the National Cancer Institute in which they determined that this treatment works great, and they decided that we should go into Phase 2 clinical trials which would be sponsored by them.
No. This gave the idea of some higher-ups at the FDA to conspire with the pharmaceutical company so that they can steal the invention from me and get it, because it was good, okay?
So that’s the whole story, okay?
Then they knew that if I’d be still free, they won’t be able to do it. Because they knew that if I would sue them, they wouldn’t have a chance in court because we have our patents before, okay?
So that’s why attempts from them to wipe me out financially, to put me to prison, to attack me from every possible angle: FDA, which is the federal government, state government, to be able to steal my invention, okay?
That’s the real thing from the National Cancer Institute and Elan Pharmaceutical.
They failed.

[They failed]

We survived, and we move forward.

[NARRATOR] These patents are full of useful information.
Aside from noticing their blatant infringement, “Compositions and Methods for Treating and Preventing Cancer”, using the distribution of Antineoplastons AS2-1’s ingredients ...
they enthusiastically state: “The neoplastic conditions treatable by this method include ...
neuroblastoma, leukemia ...
myelodisplasia, acute glioma, prostate cancer ...
breast cancer, melanoma, lung cancer ...
medulloblastoma, and lymphoma” to name a few.
They also point out how Antineoplastons can also be used as a cancer preventative.
However, the most revealing piece of information found in these patents is where they state: “Current approaches to combat cancer rely primarily on the use of chemicals and radiation, which are themselves carcinogenic, and may promote recurrences and the development of metastatic disease.” Let’s read that one again, shall we? “Current approaches to combat cancer rely primarily on the use of chemicals and radiation, which are themselves carcinogenic, and may promote recurrences and the development of metastatic disease.” [US Patent #5,605,930]

"Blood Sport," by Tara Carreon

[Dr. Michael A. Friedman, Dr. David A. Kessler, and Dr. J. Richard Crout Culling the Useless Eater Population in accordance with National Security Study Memorandum 200 (NSSM 200), by Henry Kissinger]

[Dr. JULIAN WHITAKER] Now, how could the U.S. Patent Office ...
be corrupted to the point that they issue patents on medical therapies that have already been patented, and issue them to someone who had nothing to do with their discovery or use?
How could that happen? And how could the Patent Office then assign these fraudulent patents to some of the most powerful institutions in American government?
And imagine, all of this was being done while these same government agencies were spending millions of taxpayers dollars trying to put Dr. Burzynski in jail so that he could not fight the criminal theft of his discovery.

[LI-CHUAN CHEN, PH.D., NATIONAL CANCER INSTITUTE SCIENTIST 1991-1997] They sometimes have a creed --
it's "to separate the medicine from the medicine man."
And, of course, these higher-ups at NCI, or whatever, they think, "Hey guys, we've been doing this for years.
We know what's going on."
So they think, "Well, we know what's going on with phenylacetate, phenylacetylglutamine"...
If you can outsmart the medicine man ...
you can cut a piece of the pie for yourself.
That's the name of the game.
If you cannot be the first one ...
if you can be the second one ...
and be bigger than the first one --
Steal. Why not?
That's the mentality.
You know, under the capitalist sun, there is nothing sacred.
Money talks.

[The smear campaign continues]

[STANISLAW BURZYNSKI] The smear campaign against us continues from good doctors, from American Medical Association, from American Cancer Society, despite the fact that they should have stopped a long time ago.

[JAMES RAPPAPORT, DANA-FARBER CANCER INSTITUTE, MEMBER, BOARD OF DIRECTORS] I think what is amazing is that Dr. Burzynski has had a vision, and a passion, and a zeal for 40-odd years ...
put up with being called everything short of, and probably even including, "witchdoctor," because of his firm belief that he can save people's lives.
And I mean, what that says about his character, and just the fibre of his backbone, to be willing to take that on, and to be alive and recognized when it happens ...
I mean, there are many times in history where great inventors, you know, the inventor has basically died, or was impoverished before they had a chance to see the fruition of that great invention.
And he's got a chance of doing that.

[None of the oncologists who originally diagnosed each patient presented in this film would agree to go on-camera, or submit a written statement.]

[JAMES RAPPAPORT, DANA-FARBER CANCER INSTITUTE, MEMBER, BOARD OF DIRECTORS] The doctors I know, and the clinicians I know, these people are evangelical. I mean, they are hugely vested and invested in doing what they believe is very important and good work.
It helps them get up in the morning to go to work. So folks who are invested in that kind of zealous way, you know, are going to look at anything that isn't within that vision ...
you know, they're going to look askance at it, they'll say, "That's really weird," or "That's a charlatan."
And if they had not looked so askance at it, and they had allowed him the opportunity to put this through the testing 20 years ago ...
think about how much further ahead he would be.

[Since 1995, all cancer patients who received Antineoplaston treatment in the USA, did so under the approval and supervision of the Food and Drug Administration.
These patients were treated within "Phase 2 FDA clinical trials," without the aid of the National Cancer Institute, or any other cancer research entity.]

[Antineoplastons are responsible for the first recorded cures in medical history within any FDA-approved clinical trial for inoperable brainstem gliomas in children -- with a 30%-50% cure rate. A "cure" is defined as a 5-year survival.]

[Since 2009, permission for the final phase of FDA clinical testing to allow Antineoplastons to be "FDA-approved" has been granted. The only obstacles now are the $300 million dollars needed to pay for this final phase of clinical testing --]

[and the FDA requiring children with inoperable brainstem glioma to also undergo radiation treatment in these Phase 3 trials, claiming it would be "unethical" not to do so.]

[STANISLAW BURZYNSKI] The fact that we are permitted to enter Phase 3 trials means that the treatment shows already safety and efficacy in Phase 2 trials. This means that at this moment we should receive overwhelming support, instead of being harassed as we are so far.

[JAMES RAPPAPORT, DANA-FARBER CANCER INSTITUTE, MEMBER, BOARD OF DIRECTORS] When you look at what is going on, and at how Dr. Burzynski is being handled, it is clearly a function of any time you have big business, big government, big labor, big pharma, big cancer industry -- whatever -- they become so wrapped up in protecting the institution, whatever it is, that they forget what their fundamental job is.
You know, and what's happened with big pharma and big cancer is they've forgotten to be curious about that there might be other opportunities and options out there. And they are focused on protecting their turf.

[This film is dedicated to everyone who has been affected by cancer.]

[A fully interactive transcript of this film that discloses all of its original documentation and other related sources for this project is publicly available for free at: http://www.burzynskimovie.com]

Written, directed, and produced by Eric Merola

Produced by Kate Merola

Special thanks to Stanislaw Burzynski, M.D., Ph.D. for his generous cooperation in the making of this film.

Special thanks to Julian Whitaker, M.D., for his courageous support of Dr. Burzynski and his invaluable contribution to this film.

Special thanks to Richard A. Jaffe, Esq. for his commitment in helping to maintain Dr. Burzynski’s freedom.

& Carolyn Powers for her tireless hours spent in Dr. Burzynski’s extensive records rooms locating many of the documents presented in this film.

Participants in order of appearance:

Julian Whitaker, M.D., Whitaker Wellness Institute, Newport Beach, CA, http://www.whitakerwellness.com
Stanislaw Burzynski, M.D., Ph.D., Burzynski Research Institute, http://www.burzynskiclinic.com
Jodi Fenton, Anaplastic Astrocytoma Grade III survivor
Jessical Ressel-Doeden, Brainstem Glioma survivor, parents Robin and Dan Ressel
Kelsey Hill, adrenal, lung, and liver cancer survivor, with her parents Sarah and Steve Hill, and grandmother Susan
Judge Earl Corbitt of Austin, Texas (ret.)
Dr. Li-Chuan Chen, former contract scientist for the NCI's OAM

Special thanks to those who were interviewed for this film but were excluded due to running time:
Susan Hale, Glioblastoma Grade IV survivor and father Gerald Dyer
Lieutenant Colonel James Treadwell, USMC (retired) -- Glioblastoma Multiforme Grade IV survivor and wife Victoria
Arize Onuekwusi, colon cancer survivor
Ruth Bennefield -- head, neck, and bone cancer survivor
Linda Makris -- breast cancer survivor and husband Victor
Schad Kolar -- liver cancer survivor
Walter Ciborowsky -- lung cancer survivor
Neal Dublinksy -- non-Hodgkin's lymphoma survivor

Patient from Texas Hearing 5/24/93: Paul Michaels & his mother Mary -- inoperable optic-hypothalamic glioma astrocytoma survivor
Patients from CBS this Morning 3/25/95:
Neal Dublinsky -- non-Hodgkin's lymphoma survivor
Mary Jo Siegel -- non-Hodgkin's lymphoma survivor
Pamela Winningham -- brain cancer survivor
From Congressional Hearings 2/29/96:
Sergeant Ric Schiff, father of Crystin Schiff
Mariann Kunnari, Jack Kunnari, Dustin Kunnari -- medulloblastoma brain cancer survivor

Narration, editing, art direction, and on-camera interviews by Eric Merola
Assistant camera and sound by Kate Merola
News footage:
KY-3 News, Springfield MO; CBS, ABC, CNN
Music:
Neosounds: "Fragents," "Boomer," "Mechatron," "Inside Story," by Lynne Music, "Untangled" by Erik Haddad, "Keep it Cool," by Dyamedion, "Emergency Surgery," by David Flavin, "Hitting Rock Bottom," by Perfect Solution Music, "Billy Rock," by Henry Gorman, "Breaking Point," by Alex Khaskin; Premium Beat: "Relax," and "Blues Clap," by Grandom
Stock video and illustrations: istockphoto, Pond5

Photo of child in radiation mask provided courtesy of Heidi Feyerherm, in memory of her late daughter, Chloe Feyerherm
Additional thanks:
Barbara Burzynski, M.D.
Tomasz Janicki, M.D.
Darlene Hodge
Margaret Bialonowicz
Aneta Odolski
Sonali Patil, Ph.D.
Ian Fay
Tom Fulk
Mohammad Khan, M.D.
Azad Rastesgar
Mary Jo & Steve Seigel
Kris Wisniewski
Kate Merola
Greg Burzynski, M.D.
Jon Rubin
Connie Whitaker
Debra Stockton
Sam Merola
Le Trombetta
Shahana Faridi
Peggy Dace
Rita Starr
Michael Berlin
Gregory Gardner
Foreign subtitles:
Margaret Baute (Spanish), Liza & Albal Rocher (French), Gilda Zucolella (Italian), Monika Sobczyk & Judith Hinterberg (German), Kate Merola (Polish), Anya Petrova & Larisa Tikhomirova (Russian)

Some footage has been respectfully used in this film in accordance with the Fair Use Doctrine of the U.S. Copyright Code Section 107
http://www.burzynskimovie.com
© 2011 Burzynski Movie
Unauthorized reproduction of this film is strictly prohibited.

to be continued