Burzynski Documentary Movie Film Resource for the Skeptics – Review

I found that the entire documentary, “Burzynski: Cancer Is Serious Business” directed by an American independent documentarian named Eric Merola is backed up with sources so extensive, I was unable to find a single hole in the entire production. If you are even remotely skeptical of this controversial documentary and its contents, you have the privilege to fact-check everything in the film here. (If only all investigative journalists practiced this type of transparency!)  I decided to re-publish the entire sourced transcript from the film’s main website here:

Transcript – Chapter 1 of 10 – Introduction

*This full transcript is for “Part 1”, released in 2010/2011

0:00 – 8:55 – Interactive and sourced transcript

START:

ARCHIVAL FOOTAGE: Congressional Subcommittee hearing, Feb. 29, 1996. Sgt. Ric Schiff and daughter:
My name is Sergeant Ric Schiff. I am an eleven-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—take her home and let her die, or 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 that 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 except 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 ordered 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, her 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—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.

Update: Watch a recent 2011 interview with Sgt. Ric Schiff with Dr. Mercola [click here to watch].

BURZYNSKI (main title)

Dr. JULIAN WHITAKER – on camera interview:
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.
[SOURCE: “Review of Brain Tumor Cases Treated with Antineoplastons”; National Cancer Institute (NCI) Internal Memorandum; 10/31/91; Letter from D Macfarlane, MD to S Burzynski MD, PhD; pg3 – Prefaced with 11/15/91 NCI Internal Memorandum from Chief, Investigational Drug Branch Michael J. Hawkins, MD to NCI’s Decision Network Team].

Highlighted text within on-screen 1991 National Cancer Institute internal document: 
“The previously seen tumor parenchyma is no longer present.”

Dr. JULIAN WHITAKER – on camera interview (continued):
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 PhD in biochemistry the following year. [SOURCE: Sworn Affidavit from Lublin Medical Academy]. While undergoing his research to acquire his PhD, 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. [SOURCE: Drugs Exp Clin Res. 1986; 12 Suppl 1:19]

Dr. JULIAN WHITAKER – on camera interview:
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.
[SOURCE: Anticancer Res. 2007 Jul-Aug;27(4B):2427-31]

Highlighted text within on-screen document: 
“Aetna considers antineoplaston therapy (auto-urine therapy)…” [SOURCE: Aetna.com]

Dr. JULIAN WHITAKER – on camera interview (continued): 
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 [SOURCE: Premarin Wiki], for decades—but all of the sudden it was abhorrent to our sensitivities. Well, Dr. Burzynski now synthesizes all of the Antineoplastons. [SOURCE: NCI] [SOURCE: BRI]

Extra SOURCE (not in film): 8/5/87 Congress of Pharmacology Antineoplaston presentation, Australia

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. [SOURCE: BRI]

Dr. STANISLAW BURZYNSKI – on camera interview:

From where we started in the 1970’s, is now forming a completely new approach to cancer treatment—which is called “gene-targeted therapy”. Antineoplastons are medicines which work on the genes that are causing cancer, 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. [SOURCE: NCI] 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. Antineoplastons work on close to one hundred different genes. [SOURCE: Biz Wire]

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 tumor suppressor genes switched off. The goal is to tell the body to both switch back on the tumor suppressor genes, and turn off as many oncogenes as possible. [SOURCE: Amer Cancer Soc]

Dr. STANISLAW BURZYNSKI – on camera interview: 
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 the proper amount of Antineoplastons in our system we should not develop cancer, if we are deficient—then we can develop cancer.

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 kinds of cancer to treat, he places a heavy focus on brain cancer in his clinical trials. [SOURCE: Center Watch, Texas]

Extra SOURCE (not in film): The Royal Society Of Medicine Certificate, Burzynski

Transcript – Chapter 2 of 10 – Jodi Fenton

8:55 – 14:04 – Interactive and sourced transcript

JODI FENTON – on camera interview:
On May 15th of 2000, I was diagnosed with an inoperable, stage three, anaplastic astrocytoma brain tumor [SOURCE: J Fenton Med Recs]. 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® (On screen-graphics: Temodar for Anaplastic Astrocytoma = 13.9 month median survival [SOURCE: FDA/Schering-Plough Mar 2003 PPT]) 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. “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. 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. On 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, all that’s left of the tumor is scar tissue—and I’ve been off the treatment for that entire time. So, Dr. Burzynski cured me of a brain tumor. [SOURCE: J Fenton Med Recs PDF pg5-11; Third-Party confirmation PDF pg 12-13]

ON-SCREEN TITLE CARD: 
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. [SOURCE: J Fenton Med Recs PDF pg 2-9]

Ordinarily the FDA requires that anyone that wished 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. [SOURCE: J Fenton Treat. Sum.]

ON-SCREEN TITLE CARD: 
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 October of the following year, when she stopped her antineoplaston therapy altogether. [SOURCE: J Fenton Med Recs (same as above)]

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 [SOURCE: Schering-Plough 2005, PDF pg 5]

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 [SOURCE: Neuro-Oncology 2008]

[Go here for more: Jodi Fenton’s medical records, peer-reviewed statistical data from FDA clinical trials, her interview and more about her story]

Dr. JULIAN WHITAKER – on camera interview: 
If Jodi Fenton had undergone the therapies originally prescribed to her, her life would have been very different. [Temodar Side Effects PDF 6-13] [Radiation side effects ACS]

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 – on camera interview:
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.

Transcript – Chapter 3 of 10 – Jessica Ressel

14:04 – 22:10 – Interactive sourced transcript

Dr. JULIAN WHITAKER – on camera interview: 
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-in-large, are 100% fatal. This would be the worst class of cancer to treat, but he began getting enormous results.

Dr. STANISLAW BURZYNSKI – on camera interview: 
Arguably, the worst type of cancer is inoperable brainstem glioma. It usually occurs in the brain of a child. And, unfortunately, there is very little that can be done. Radiation is the only “treatment” available which can be used to slow down the progress. So that’s the type of tumor for which there is no curative treatment, no chemotherapy which has been approved, and numerous clinical trials were performed but failed in the past [SOURCE: UCSF Med Center PDF pg 6] [SOURCE: CBCF].

So 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.
[SOURCE: Pedatric Drugs 2006 PDF pg 8]

JESSICA, ROBIN (mother), and DAN RESSEL (father) – on camera interview:
ROBIN RESSEL:

She was diagnosed in March of 1996, she was eleven—and she pretty much just started having really bad double vision is how we discovered it—and 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, which means 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. [SOURCE: J Ressel Med Recs PDF pg 2, 5-7]

JESSICA RESSEL:
The thing is, with the radiation, what it would do to you from what I understood is, 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 be come deaf, 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 eleven year-old body, and basically you’d go into a vegetative state, where you couldn’t take care of yourself, which wasn’t a very good quality of life. [SOURCE: UCSF Med Center PDF pg 9]

ROBIN RESSEL:
My big concern was with the oncologist that we were originally dealing with was how it would effect her development, and when she started to enter the teenage years, starting her period, and growing and developing—and he just looked at me and 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.”

ON-SCREEN TITLE CARD:
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. [SOURCE: J Ressel Med Recs PDF pg 2]

KY-3 NEWS SPRINGFIELD, Nov. 19, 1996
NEWSCASTER VO:

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 Ressel’s 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 that 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.

KY-3 NEWS SPRINGFIELD, Nov. 19, 1996
JESSICA RESSEL (age 11):

And I would only live for like three months, and live in pain and that’s it. Not a fun life. I’d still die.

KY-3 NEWS SPRINGFIELD, Nov. 19, 1996
NEWSCASTER VO:

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.

ON-SCREEN TITLE CARD:
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. [SOURCE: J Ressel Med Recs PDF pg 8-17]

ROBIN RESSEL (on camera interview):
There were very few doctors that you would tell them that you were seeing Dr. 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 that we found Dr. Burzynski because literally it did save her life. Here she is now twenty-four, and she’s got a little boy who is almost five, and 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 see the results from FDA-supervised clinical trials treating Jessica’s type of cancer. 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 live beyond five years—presumably being devastated by the amount of chemotherapy and radiation. 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. [SOURCE: Pedatric Drugs 2006 PDF pg 8]

[Jessica Ressel’s medical records, multiple third-party diagnostic confirmation, third-party recovery confirmation, peer-reviewed FDA clinical trial statistical data, watch her interview and more]

Dr. STANISLAW BURZYNSKI – on camera interview:
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 lives. No side-effects from the treatment, no symptoms, no sign of tumors—back to life. We started some of them as children, and now they have their own children. There is no impairment of fertility. They just live normals lives. The bad thing however is that we know that we cannot help 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 the “second and third generation of Antineoplastons” to make the treatment more effective, to cover a broader spectrum, and to be easier to administer.

Transcript – Chapter 4 of 10 – Kelsey Hill

22:10 – 28:48 – Interactive sourced transcript

ON-SCREEN TITLE CARD:
Adrenocortical Carcinoma with metastasis to the lungs and liver: adrenal, lung, and liver cancer, clinical trial

KELSEY, SARAH (mother), and STEVE HILL (father) – on camera interview.
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 everywhere, it was in her kidney and her liver 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 they would even work. The drugs were: Mitotane…

ON-SCREEN TITLE CARD:
MITOTANE CHEMOTHERAPY: Appropriate studies have not been performed to find out Mitotane’s safety or effectiveness in children. [SOURCE: Mayo Clinic]

SARAH HILL VO:
… Doxorubicin …

ON-SCREEN TITLE CARD:
DOXORUBICIN CHEMOTHERAPY: Side effects: Leukemia, Heart Failure, Infertility, Vomiting, Mouth Sores. Nickname “Red Death” [SOURCE: ACS] [SOURCE: How Doctors Think]

SARAH HILL VO:
… Etoposide …

ON-SCREEN TITLE CARD:
ETOPOSIDE CHEMOTHERAPY: Side effects: Leukemia, Nerve Damage, Inability to Fight Infections, Vomiting. [SOURCE: ACS]

SARAH HILL VO:
… and Cisplatin.

ON-SCREEN TITLE CARD:
CISPLATIN CHEMOTHERAPY: Side effects: Kidney Damage, Hearing Damage, Nerve Damage, Infertility, Vomiting. [SOURCE: ACS]

SARAH HILL, on-camera interview (continued):
… and they told us admittedly “this is the most toxic regimen that we have.”  We have a six-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, why would I want her last few months of life to be miserable?”

STEVE HILL, on-camera interview:
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 three years old and she got cancer of some kind. He told me about what that was like at that time. 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 was it like when a doctor tells you, that’s it. We can’t do any more.”

My uncle Ray told me that for the last few weeks of my cousin’s life, they celebrated Christmas once a week. They had a Christmas and a birthday once a week until that was it. I was putting myself in his shoes, and I was just thinking, I couldn’t watch my daughter whither away, and at least I wanted whatever time I had to be happy. As happy as could be anyway—and not just watch her whither away from chemo that’s not doing any good any more.

SARAH HILL, on-camera interview:
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 it worked” but at that point I was like “well, yours doesn’t really work either.”

ON-SCREEN TITLE CARD:
MITOTANE CHEMOTHERAPY: Approved: July 8, 1970. Derived from DDT (insecticide). [SOURCE: FDA] [SOURCE: Pub Chem]

STEVE HILL VO:
The other thing that I did, on the FDA’s website you can look up the day in which any drug was granted FDA approval and I realized that the oldest drug they wanted to give Kelsey had come out in the early 1970’s…

ON-SCREEN TITLE CARD:
DOXORUBICIN CHEMOTHERAPY: Approved: December 23, 1987 [SOURCE: FDA]

STEVE HILL VO:
… the newest drug they wanted to give Kelsey came out around 1988…

ON-SCREEN TITLE CARD:

ETOPOSIDE CHEMOTHERAPY: Approved: November 10, 1983 [SOURCE: FDA]

STEVE HILL VO:
… and I realized, this isn’t the cutting edge of technology, they’re giving us the same old stuff …

ON-SCREEN TITLE CARD:
CISPLATIN CHEMOTHERAPY: Approved: December 19, 1978 [SOURCE: FDA]

STEVE HILL VO & on-camera interview:
… 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.”  I looked at it like, well, if she’s only got approximately 9 months to live, and we come over here and we don’t have all the side-effects… well, in 9 month’s time, which am I going to be better off doing?

SARAH HILL on-camera interview:
Right.

STEVE HILL VO & on-camera interview:
If the ending result is the same?

ON-SCREEN TITLE CARD:
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 my 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. [SOURCE: MD Ander, Texas Med Brch, scan]

ON-SCREEN TITLE CARD:
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. [SOURCE: K Hill MRI results]

[Kelsey Hill’s medical records extended, watch her interview and more about her story]

Transcript – Chapter 5 of 10 – NCI & FDA Intro

28:48 – 34:57 – Interactive sourced transcript

NARRATOR:
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 dreaded 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 tax-payer money to be granted to Dr. Burzynski’s FDA-approved clinical trials.

Dr. STANISLAW BURZYNSKI – on camera interview: 
A single Phase 3 trial will cost about twenty-five million dollars. So how many can you run? You may run 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. 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. No one is giving me any money, okay? I am working like in a war-time condition, like working somewhere in the Gaza Strip or the West Bank—when the bombs are falling, we still have to treat patients, and we still have to do Phase 2 clinical trials.

ON-SCREEN TITLE CARD:
National Cancer Institute annual budget: $5,200,000,000. [SOURCE: NCI]

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 – on camera interview: 
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, we’ve got thousands of doctors in oncology, and in oncology residency programs, we’ve got the pharmaceutical industry pumping out chemotherapeutic agents every month. There are all kinds of machines that deliver radiation, we’ve got all this stuff in the war on cancer, and it’s trillions of dollars. [SOURCE: ACS]

I find it very interesting that we have all these walks for the cure of cancer. We’ve got all the wristbands, we’ve got all the donations—”we’re going to find a cure in this decade.” All this money keeps pouring in—and it all goes to the same guys.

ON-SCREEN TITLE CARD:
PhRMA: New Medicines. New Hope.

NARRATOR: 
The pharmaceutical industry is arguably the most profitable industry on our planet, with it’s profits being triple that of all of the Fortune 500 companies. [SOURCE: Fortune 4/30/07 Company Annual Reports] [Time Mag 2004]

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 it’s 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 it’s 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…

NARRATOR (reading along with highlighted portions of a Boston Globe article): 
… 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 it’s 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. [SOURCE: Boston Globe 2007]

NARRATOR (reading along with highlighted portions of the FDA’s Prescription Drug User Fee Rates for Fiscal Year 2010): 
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. [SOURCE: FDA PDF pg 1]

NARRATOR:
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. [SOURCE: LA Times 2000] In a 2007 health policy report, sponsored by Pfizer, supporting the renewal of these user fees, they revealed…

NARRATOR (reading along with highlighted portions of a George Washington University’s Health Policy Response Project, co-authored by Pfizer): 
… that the median review time for priority drugs—those for serious life-threatening diseases 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. [SOURCE: G Washington/Pfizer Report PDF pg 3]

NARRATOR:
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.

Transcript – Chapter 6 of 10 – Texas Medical Board vs. Dr. Burzynski

34:57 – 48:03 – Interactive sourced transcript

ON-SCREEN TITLE CARD:

(Note: this page of the transcript does not contain the Judge Earl Corbitt section, which was recently added to the project in 2011 for the Documentary Channel & Netflix airings (All DVDs contain the Earl Corbitt interview). This version of the script contains the actual court transcript of the 1993 trial itself, which is more condemning than the Earl Corbitt interview, but did not work as well on screen, which is why we chose to interview the Judge later and replace that scene. We will update it soon.)

Dr. STANISLAW BURZYNSKI – on camera interview: 
Before I started, I asked my lawyers for their advice: “Can I use an experimental treatment—which was the treatment of Antineoplastons—can I use this in my private practice, and can I be involved in cancer research, as simple as any private company?”

NARRATOR (reading along with highlighted portions of a legal opinion letter from his attorneys dated June 21, 1977): 
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 Taxes 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 in 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 activity 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. [SOURCE: Legal Opinion Letter 1977]

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.

ON-SCREEN TITLE CARD:
Texas Medical Board

Dr. STANISLAW BURZYNSKI – on camera interview: 
For a long time, I didn’t have any contact with the Texas Board of Medical Examiners, until around 1984, some of my patients told me that they were approached by the agents sent to them by the Texas Board of Medical Examiners who were trying to convince them to file complaints against me. This was shocking to me. 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 live 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 with the Texas Board of Medical Examiners. And obviously the problems began. 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. [SOURCE: TMB 1986 Letter]

This was a very unpleasant investigation, they were trying to convince me again to stop my research and to stop treating patients. After about two year 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. They informed me that such medical records would be reviewed by their expert oncologists and if they are satisfied that I am not harming patients and the patients are benefiting from my activity then they would leave me in peace. I was very happy with this, I believed that the 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 (reading along with highlighted portions of a notarized agreement between Dr. Burzynski and the Texas State Board of Medical Examiners, and various legal related complaints served to Dr. Burzynski by the Texas Medical Board): 
In 1986, Dr. Burzynski agreed to present to the Texas State Board of Medical Examiners  forty 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 medial board, he didn’t hear back from them, leaving him to assume that the board was satisfied and would leave him in peace. [SOURCE: 11/18/86 TMB Affidavit]

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. [SOURCE: 9/6/88 TMB Complaint]

Dr. STANISLAW BURZYNSKI – on camera interview: 
It was a shock to me. I believed in justice, I believed in the high ethics of the board, but this was just a lie.

NARRATOR (reading along with highlighted portions of various legal related complaints served to Dr. Burzynski by the Texas Medical Board): 
It was abundantly clear that the medical board had no case against Burzynski. Which prompted the board to file their first amended complaint in 1990 [SOURCE: 1990 TMB 1st Am Com]—still the board had no case—which prompted them to file a second amended complaint in 1992 [SOURCE: 1992 TMB 2nd Am Com]. 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, sixty 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. [SOURCE: Motion To Dismiss Strike 1993] Finally in May of 1993, this case went to trial.

NARRATOR (reading along with title card of Dr. Nicholas Patronas): 
During this trial, one of the National Cancer Institute’s leading experts, Dr. Nicholas Patronas, a board-certified radiologist since 1973, professor of radiology at Georgetown University, and founder of the neuroradiology section of the National Cancer Institute [SOURCE: NIH Staff Pages]—recognized the absurdity of the Texas Medical Board’s case against Burzynski, put his own career on the line and flew himself to Texas to testify on Dr. Burzynski’s behalf. Dr. Patronas testified under oath his role at the National Cancer Institute.

NARRATOR (reading along with the official court transcript from the May 24, 1993 hearing): [SOURCE: Original complete court transcript of the entire testimony 1993]

Q (Jaffe): Basically, just in layman’s terms, you do all of the imaging work and interpretation for the National Cancer Institute’s testing of drugs?

A (Dr. Patronas): Exactly. That’s my job, to assess the effectiveness of the drugs that are given there.

Q (Jaffe): Did there come a time when you became aware of Dr. Burzynski?

A (Dr. Patronas): Yes, the National Cancer Institute asked me to join a group of other physicians and scientists, and come to Houston on a site visit to Dr. Burzynski’s Institute. I was called as an expert  in assessing the images to evaluate the effectiveness of his treatment. The basic conclusion, was that in five of the patients with brain tumors, that were fairly large, the tumor resolved, disappeared.

Q (Jaffe): And that’s part of what you do at the hospital, is to evaluate treatments on brain cancer patients? A: Well, since I am the neuroradiologist I see all brain tumors. And I see a large volume of them.

Q (Jaffe): You testified that five of the patients had their tumors resolved, they all…

A (Dr. Patronas): Disappeared.

Q (Jaffe): Disappeared? Can you give us some kind of context of that? How often does that happen? Just by spontaneous remission?

A (Dr. Patronas): I’m not aware that spontaneous remission occurs. The available treatments rarely produce results like that. The only medication, the only treatment, which I think is a last resort, is radiation therapy. Conventional chemotherapy is—provides very little, nothing, basically. So when this happens it is very rare. In these cases, all of the patients had already failed radiation.

Q (Jaffe): What happens with these patients, who failed radiation, with brain cancer?

A (Dr. Patronas): That’s it. They die.

Q (Jaffe): You are saying, that if someone has already failed radiation, there’s not much else?

A (Dr. Patronas): Nothing to offer, exactly.

Q (Jaffe): And there is nothing that you can do at the National Cancer Institute?

A (Dr. Patronas): Nothing we can do, not at this present time.

Q (Jaffe): What about these five patients? How come they lived?

A (Dr. Patronas): Well, it’s amazing, the fact that they are not handicapped from the side effects of any treatment, and the side effects of most aggressive treatments are worse than the tumor itself, so these particular individuals not only survived, but they didn’t have major side effects. So I think it’s impressive and unbelievable.

Q (Jaffe): How many times have you seen this in your experience? How often does this happen?

A (Dr. Patronas): I don’t. I have not seen it at any time.

Q (Jaffe): Now, let me ask you your opinion or advice. Based on what you have seen, what would happen, let’s say, for some reason Dr Burzynski’s brain tumor patients can’t get his medicine anymore, and have to go off treatment. What’s going to happen to them?

MR. HELMCAMP (prosecutor): Objection, Your Honor, not relevant.

MR. JAFFE (defense): I think it is relevant. That’s really the issue we are advocating in this case.

JUDGE: Overruled.

A (Dr. Patronas): I think these patients will die. [SOURCE: Original complete court transcript of the entire testimony 1993 (same as above)]

NARRATOR (reading from highlighted sections of “findings of fact and conclusions of law from this case”): 
Not surprisingly, 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. [SOURCE: Findings of Fact/Conclusions of Law 1993]

(EXTRA SOURCE: Letter from Homer Goehrs, MD (Radiation Oncologist) whose friend was treated by Antineoplastons who also wrote a letter to the Texas Medical Board in support of Burzynski]

NARRATOR:
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 taxpayer’s money, pursuing a case they knew they couldn’t win. Well, think again.

MONTAGE OF VARIOUS NEW REPORTS FROM 1995.
News anchor VO#1: 

The state of Texas wants Houston doctor Stanislaw Burzynski to stop treating his patients with drugs that 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.

MONTAGE (continued) Dr. Burzynski in 1995:
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, these people will die.

MONTAGE (continued) News anchor VO#1:
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.

MONTAGE (continued) News anchor VO#2:
Dr. Bruce Cohen is the director of neurologic oncology at the prestigious Cleveland Clinic.

MONTAGE (continued) Dr. Bruce Cohen:
The only explanation is that it shrunk because of the therapy Paul has received.

MONTAGE (continued) News anchor VO#2:
He confirmed Dr. Burzynski’s results on Paul.

MONTAGE (continued) Paul’s mother:
Seven years that we’ve had Paul and he’s been healthy, I owe it to this man, and there is no way I’d ever be able to thank him enough for what he’s done for us.

MONTAGE (continued) News anchor VO#1:
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.

MONTAGE (continued) 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 [FDA] approved, says quote: “The efficacy of Antineoplastons in the treatment of human cancers is not of issue in these proceedings.” [SOURCE: 1994 TMB Order Page 4, #23]

MONTAGE (continued) ABC News, Rick Jaffe (Burzynski’s attorney):
It takes a bureaucrat to come up with that idea, because, to a layman, that would really be the question.

MONTAGE (continued) ABC News:
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. [SOURCE: 1995 Final Order to TMB] 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 clip:
For this story we wanted to talk to the FDA about it’s policies and procedures. The FDA did agree to talk to us on background where it wouldn’t be quoted, but they repeatedly refused our requests for on-camera interviews.

Transcript – Chapter 7 of 10 – The FDA vs. Dr. Burzynski

48:03 – 1:13:42 – Interactive sourced transcript

ON-SCREEN TITLE CARD:

NARRATOR: 
While they were busy pressuring the Texas State Medical Board to try to revoke Dr. Burzynski’s medial 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. [SOURCE: Sample Patent (too many patents to list)]

Apparently, the FDA had not ruled out the possibility of this happening one day.

NARRATOR (reading from highlighted sections of “The Cancer Letter, Mar. 12, 1976”): 
One 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. [SOURCE: Cancer Letter 3/12/76 pg 3]

NARRATOR:
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.” [SOURCE: The Spotlight, January 18, 1982]

And so, the fiercest fight in FDA history began.

ARCHIVAL FOOTAGE: 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 (reading from highlighted sections of a Civil Action/Motion for Summary Judgment May 2, 1983): 
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 be 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. [SOURCE: 1983 FDA letter to Judge pg 2]

Regardless of these threats from the FDA…

ARCHIVAL FOOTAGE: Rick Jaffe, Burzynski’s attorney – Congressional Subcommittee hearing, July 25, 1995 (continued):
… the judge in the case basically said 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 – on camera interview: 
Obviously they came armed, and they confiscated all of our medical records. 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, we were treating very sick people and they took their medical records, 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.

ARCHIVAL FOOTAGE: Rick Jaffe, Burzynski’s attorney – Congressional Subcommittee hearing, July 25, 1995 (continued):
They presented the evidence to the grand jury, no indictment. In 1986 they come back and seize another 100,000 documents, no indictment. In 1990, another grand jury, either the second or the third, they present more documents, Dr. Burzynski testifies extensively before the grand jury, no indictment. In 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…

ARCHIVAL NEWS FOOTAGE: CBS This Morning, 3/25/95, Host – Harry Smith:
Let me play devil’s advocate, here you all very desperate folk, had undergone some cancer treatment correct?

Patient, Mary Jo Siegel: 
No, I had no treatment.

Host, Harry Smith:
None at all for you? Then let me go after these guys for example, you 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 – Non-Hodgkin’s Lymphoma patient/survivor:
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 the sudden a new tumor comes in, how could that first treatment have helped the subsequent tumor?

ARCHIVAL FOOTAGE: Rick Jaffe, Burzynski’s attorney – Congressional Subcommittee hearing, July 25, 1995 (continued):
Later that day the FDA came, another raid. More patients documents, more subpoenas… [SOURCE: (not mentioned in film) 1995 letter from AMPAC re: FDA raid]

ARCHIVAL NEWS FOOTAGE: CBS This Morning, 3/28/95, Host – Harry Smith:
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: 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 “compassionate use INDs” (investigational new drug).

ARCHIVAL FOOTAGE: Rick Jaffe, Burzynski’s attorney – Congressional Subcommittee hearing, July 25, 1995 (continued):
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. Let’s 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’d 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 Antineoplastons—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 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.

ON-SCREEN TITLE:
Dr. David A. Kessler Commissioner, The Food and Drug Administration

ARCHIVAL FOOTAGE:
Oversight & Investigations Subcommittee Hearings 11/15/95; Hon. Joe Barton: 
In my opinion, you have every right to use the investigative authority and the judicial resources of the federal government to the justice department 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 illogical 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’ll ask council 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 am left then, with rather strong inference, that if you convene four separate grand juries and there is no indictment returned, not withstanding that prosecutors tell us always that it’s possible to indict a ham sandwich—that probably there’s not much there.

[SOURCE: (not mentioned in film) Letter from Congress to Janet Reno to end the FDA harassment and abuse of the criminal justice system against Burzynski]

NARRATOR:
Dozen’s 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.

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.

Patient #2: 
I’ve had no chemotherapy, I’ve had no radiation, I choose 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.

Patient #3: 
We’re frustrated, there are rights—our 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 pug on my daddy”. And that just broke my heart and broke my wife’s heart.

Patient #3’s wife: 
My husband is a walking miracle, sixteen months ago our doctors told us there is nothing else they can do, and they told us to enjoy what little life he has 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?!

Patient #4: 
I have a report from my family physician which tells how well I am doing, my tumors are leaving my body, and 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 !!

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

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 that 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 tyrant dictator Ceauscescu, never stopped a doctor from treating anybody. How can we have something like this in the United States?

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

MONTAGE OF VARIOUS NEW REPORTS FROM 1996; “Hard Copy” anchor:
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” 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. Burzynski on “Hard Copy” 1996:
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 DC to protest his indictment, but many of them testified again before another Congressional Hearing headed by Congressman Joe Barton.

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

Mariann Kunnari: Yes, that’s correct.

Hon. Joe Barton: 
From Aurora, Minnesota.

Mariann Kunnari (with son Dustin): 
This is Dustin Kunnari and he is on Dr. Burzynski’s antineoplaston treatment. And this is my husband, Jack Kunnari. Now, in February of 1994 our lives were drastically changed. My son Dustin was only two and a half years old at the time—he has 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 into 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 one-inch by one-inch 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 four-year-old, who has out-lived his prognosis. There is not 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 ravishes of smoking. If Dr. Kessler loves children so much, why have he and his agency been trying so hard to cut off my son’s last hope for life? Without this treatment, my son will die.

NARRATOR (with photos of Dustin Kunnari):
This is a photo of Dustin Kunnari at four years old in 1996. This is photo of Dustin Kunnari at 18 years old in 2009, and his brain cancer never returned.

Dr. STANISLAW BURZYNSKI – on camera interview: 
In 1996, because of pressure from the politicians and American opinion, the FDA agreed to accept all of the patients for 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 had to create a special task force 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 types 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 had ever wanted. Even still, the FDA would not back down in making sure Burzynski’s [criminal] trial moved forward.

NARRATOR (reading from highlighted sections of a Washington Times article, Dec. 5, 1996): 
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. [SOURCE: Wash Times 12/5/96]

ARCHIVAL NEWS FOOTAGE: CNN, Charles Zewe, Jan. 1997:
The issue of whether Antineoplastons work may not even come up at the trial. The judge says “that’s not relevant.” But the defense contends that’s exactly the point. And what was done in developing the drug and administering it, was done to save lives.

NARRATOR: 
This trial cost the American taxpayer $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 an injustice being done to Dr. Burzynski, his readers sent in close to 18,000 checks in small donations for Burzynski’s legal defense. [SOURCE: Whitaker’s Health & Healing 1996]

ARCHIVAL NEWS FOOTAGE: CNN, Charles Zewe (VO), 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. [SOURCE: NY Times 3/4/97] [SOURCE: Court Document showing first acquittal]

ARCHIVAL FOOTAGE MONTAGE: The jurors, March 4, 1997:
Q: You voted to acquit?

Juror #1: To acquit, absolutely.

Juror #2: Not guilty.

Juror #3: I voted for acquittal.

Juror #4: I voted my mind, and my heart…

Juror #3: I do not believe that Dr. Burzynski is a criminal.

Juror #4: …and I had voted to acquit…

NARRATOR: 
But the FDA was still not backing down. They took Dr. 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. [SOURCE: NY Times 5/18/97] [SOURCE: Court Document showing Dismissal]

The FDA’s facade in 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 court house during the second case.

ARCHIVAL FOOTAGE MONTAGE: The Jurors, March 19, 1997:
Juror #4: I am appalled at the Food and Drug Administration and their actions.

Juror #5: We’re here today, basically, to protest the witch hunt that’s going on by the FDA.

Juror #1: We have to stick together and really support these patients that are suffering not only health-wise but having to come down here to make a stand against the FDA.

Juror #6: 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. [SOURCE: Court Document showing final acquittal]

ARCHIVAL FOOTAGE MONTAGE: 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 – on camera interview: 
There were many patients who would have liked to testify on our behalf and convince the jury and the judge that without the treatment they would 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 the medicine, they were trying to keep it away from the jury. If this information would have been presented to the jurors, then this trial would have been finished very quickly. [SOURCE: Wash Times 12/5/96]

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 was saving the lives of patients was not presented to them. And I was sick listening to the lies of prosecutors from the 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 in a sneaky way, and that’s what is horrible, that’s what should be exposed because I think the United States deserves better.

(Not included in film: Read a letter from Oncologist Robert Burdick, MD of Seattle Washington to Federal Judge Sim Lake—who reviewed Burzynski’s patients and verified and vouched for his treatment).

Transcript – Chapter 8 of 10 – NCI & PhRMA vs. Dr. Burzynski

1:13:42 – 1:30:18 – Interactive sourced transcript

(Note: this page of the transcript does not contain the Dr. Chen sections, which was recently added to the project in 2011 for the Documentary Channel & Netflix airings. We will update soon.)

ON-SCREEN TITLE CARD:

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” [SOURCE: Letter to Burzynski from Chugai 1/16/87],

and the Italian pharmaceutical company “Sigma-Tau” [SOURCE: Sigma-Tau 10/10/89 Letter],

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. [SOURCE: Sigma-Tau 10/10/89 Letter pg 1]

Then, by 1990, it seemed that Burzynski’s luck had finally changed. Burzynski has apparently treated the sister-in-law of the Chairman and CEO of Elan Pharmaceuticals.
[SOURCE: Letter to Burzynski from Elan CEO 4/23/90 pg 3]

Elan enthusiastically drafted a letter of intent, stating they would aggressively pursue the filing of the 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.
[SOURCE: Letter to Burzynski from Elan CEO 4/23/90 pg 2]

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”. [SOURCE: Oncology News July/August 1990]

Dr. STANISLAW BURZYNSKI – on camera interview:

In 1989, we retained Dr. Dvorit Samid as our consultant. Dr. Samid at that time worked at the Uniformed Services Medical School in Baltimore, and later she moved to the National Cancer Institute. She did a lot of work with Antineoplaston’s ingredients.
[SOURCE: Series of type-written correspondence between Dr. Samid and Dr. Burzynski 1988-1989]
[SOURCE: 12/4/89 Letter from Dr. Samid to BRI]
[SOURCE: Research Proposal for Antineoplaston AS2-1 by Dr. Samid 1990]
[SOURCE: Dr. Samid documented as saying how detractors were trying to “kill me” and how presenting Antineoplaston work was like “swimming in politics”]

Unfortunately when the pharmaceutical company entered the picture—Elan Pharmaceutical—our consultant Dr. Samid became too close. She really became a consultant for Elan Pharmaceutical and she was working with Elan from this time. [SOURCE: 1992 Cancer Research article with Dr. Samid under the NCI testing PA, an Antineoplaston metabolite]

NARRATOR:
And suddenly, Elan Pharmaceuticals terminated their licensing agreement, stating…

NARRATOR (reading from highlighted portions of a letter from Elan): 
Elan has significant doubt as to whether the active substances comprising of Antineoplastons have patent protection, thereby rendering an agreement meaningless. [SOURCE: 9/24/90 Elan Cancellation Letter]

Dr. STANISLAW BURZYNSKI – on camera interview: 
Antineoplastons are not just one chemical. We have different ingredients in Antineoplastons. One of these ingredients was known before. We discovered that this was the metabolite of Antineoplastons, and it was known and it was available before. So when we patented our invention, our lawyers told us “look, you can’t patent this particular ingredient because it was known before, let’s list in your patients, but don’t patent this because you will never get a patent for that.” But this is the least important ingredient of Antineoplastons.
[SOURCE: Sample Patent (too many patents to list)]
[SOURCE: Orphan Drug Status as late as 1998 for Elan still trying to capitalize on Phenylacetate]
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.
[SOURCE: Court transcript of 1993 testimony]

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.
[SOURCE: 11/15/91 Letter and 10/30/91 Review of Brain Cancers Treated by Burzynski by the NCI]

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…

NARRATOR (reading from highlighted portions of an internal NCI memo 10/21/91):
“…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.
[SOURCE: Letter from Dr. Friedman to NCI Director 10/31/91]

NARRATOR:
The National Cancer Institute’s “Decision Network” then convened, and gave the green light to conduct government-sponsored clinical trials of Antineoplastons.
[SOURCE: 12/2/91 NCI Decision Network Report on Antineoplastons]

Dr. STANISLAW BURZYNSKI – on camera interview: 
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. 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 four years, and 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 – on camera interview: 
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 use the other Antineoplastons. One of them contains phenylacetate as the second ingredient. Phenylacetate alone has very small activity, it’s not very effective.

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:

NARRATOR (reading from highlighted sections of the published phenylacetate study):
“…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.”
[SOURCE: 1992 Cancer Research article with Dr. Samid under the NCI testing PA, an Antineoplaston metabolite]

NARRATOR:
The National Cancer Institute apparently pretended that they had discovered this all on their own. 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 twelve years before. Abandoned by the National Cancer Institute, he sat powerless on the sidelines as the attempted high-jacking 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.

Dr. STANISLAW BURZYNSKI – on camera interview: 
The use of phenylacetate alone was not successful, and the NCI or Elan could not use the other ingredients of Antineoplastons 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. [SOURCE: Samid and Phenylacetate profiled in “Protocol” for cancer treatment]

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. From the moment this dialogue was re-opened, the National Cancer Institute proposed altering the treatment protocols that Burzynski had spent 20 years perfecting. Burzynski told them, that until they agree to a protocol that he has confidence in, he was not going to provide the National Cancer Institute with any Antineoplastons.

NARRATOR (reading from highlighted sections of letters between Dr. Burzynski, various members of the NCI, Dr. Michael Friedman of the NCI, and NCI protocol documents): 
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.” [SOURCE: Letter from NCI’s Friedman to Burzynski 10/20/93, pg 1, 2, 4]

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.” [SOURCE: Letter from Burzynski to NCI’s Friedman 10/26/93, pg 1, 5]

NARRATOR (reading from protocol documents & statistical documents):

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 centimeters, more than one tumor, or with metastasis are excluded.
[SOURCE: NCI Protocol Exclusions for Phase 2 trials 1/18/94, pg 2] [SOURCE: NCI Protocol rules]

After everything was approved and Burzynski released his medicine, a full year passes, in which time over 15,000 Americans had 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. [SOURCE: Incidence Rates]

So, they used this as an excuse to go behind Burzynski’s back, again, and take it upon themselves to drastically alter the protocols. [SOURCE: NCI Trial changes 1/31/95] [SOURCE: Letter from NCI to Burzynski 4/3/95]

NARRATOR: (reading from highlighted sections of a letter from Dr. Burzynski Dr. Michael Friedman of the NCI):
“Dr. Friedman, it has been brought to my attention that the protocol has been amended to accept patients with tumors measuring over 5 centimeters, multiple tumors, or with metastasis. 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 cancelled immediately and the original protocol be used as promised.”
[SOURCE: Letter from Burzynski to Friedman 3/29/95]

NARRATOR: (reading from highlighted sections of a letter from the NCI to Dr. Burzynski):
The National Cancer Institute responds: sorry, but “the amendments have been approved”. [SOURCE: Letter from NCI to Burzynski 4/3/95]

NARRATOR: (reading from highlighted sections of a letter from Dr. Burzynski Dr. Michael Friedman of the NCI):
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.” [SOURCE: Letter from Burzynski to NCI 4/20/95]

ARCHIVAL NEWS FOOTAGE, “ABC”, May, 1997:
TV Anchor (VO):

These trials have been conducted at the Mayo Clinic in Minnesota, and the Sloan-Kettering Hospital in New York. Currently there are only eight patients enrolled.

Dr. Michael Friedman on camera: 
I’m very dissatisfied with that because our desire is achieve the proper enrollment in as quickly a manner as we can in order to really test this hypothesis.

TV Anchor (VO):
Friedman blamed Burzynski for this slow motion, saying Burzynski restricted admissions to 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. Burzynski (on camera):
We get the idea that the main interest is to let these patients die rapidly, and make sure that the treatment will never work.

TV Anchor (VO):
Dr. Burzynski has threatened legal action to halt these new admissions, and the NCI has suspended recruiting, leaving the trials with just those scientifically unsatisfactory eight patients. Meanwhile both the FDA and the Texas Medical Board are still trying to stop Burzynski.

NARRATOR:
On May 8th of 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.

NARRATOR (reading from highlighted sections of leaked internal NCI memo): 
“For the record. The clinical trials monitoring service 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 inquires that may be related to the trials or Dr. Burzynski are to be referred to the associate director: Dr. Michael Friedman.” [SOURCE: Internal NCI Memo 5/8/95]

[EXTRA SOURCE (not in film): May 16, 1995 Letter from Burzynski to Friedman] (more extra sources at bottom of this page)

NARRATOR (reading from highlighted sections of letters from Dr. Michael Friedman of the NCI to Dr. Burzynski): 
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.” [SOURCE: Letter from Friedman to Burzynski 6/6/95]

NARRATOR: (reading from highlighted sections of a letter from Dr. Burzynski Dr. Michael Friedman of the NCI):
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.” [SOURCE: Letter from Burzynski to Friedman 6/22/95]

NARRATOR:
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 – on camera interview: 
It took us at least half-a-year before we forced the 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. On top of that, patients were forced to stop the treatment of Antineoplastons because of massive fluid retention. This is something that 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 how this could happen. I knew that the patients were receiving a lot of intravenous fluid, but then we learned that perhaps the fluids which they were receiving were not Antineoplastons.

NARRATOR (reading from highlighted sections of an Oct. 1995 NCI Public Press release): 
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.” [SOURCE: 1995 NCI Cancer Facts and Figures]

NARRATOR:
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 Antineoplastons trials in the peer-reviewed medical literature.

NARRATOR (reading from highlighted sections of the peer-reviewed article in “Mayo Clinic Proceedings” Feb. 1999): 
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. [SOURCE: Feb. 1999 Mayo Clinic Publication pg 2, 3 PDF]

Dr. STANISLAW BURZYNSKI – on camera interview (VO while showing the data): 
We compared this to the data which we have in our studies. We found that they were severely diluting the medicine, and this is why the patients had fluid overload.

Antineoplaston AS2-1 consists of two ingredients: called Phenylacetate, and Phenylacetlglutamine. And about 2.7 times lower level of Phenylacetate was found in the patient’s blood compared to what we see in our patients who receive successful treatment.

Phenylacetlglutamine, there was about a 36 times lower level in patient’s blood compared to what we see in our patients who receive the right dosage of Antineoplastons.

And the concentrations of Phenylacetylisoglutamine, one of the main ingredients of Antineoplaston A10, were close to one hundred and seventy times lower than what we see in the treatment of patients with Antineoplastons. [SOURCE: 1998 FDA Report on Antineoplastons translated from pg 22]

Dr. STANISLAW BURZYNSKI – on camera interview: 
And that’s what we found out from the patient’s husbands or the patients themselves. That’s what they were doing. So this was horrible. This was a criminal act. They should be prosecuted for that.

Because obviously, they knew what they were doing, and they knew that these patients had really no chance to respond to any treatment, they were going to die. And that’s what happened. After we realized what they were doing, we decided to force them to stop the clinical trials. And since then obviously, The National Cancer Institute hates us, they do whatever they can but they do not cooperate with us anymore.

*[EXTRA SOURCE: See the package Burzynski sent to the NCI, dozens of members of Congress, Senators, and mainstream news organizations in an attempt to expose the above events—only to fall on deaf ears 8.5MB]*

Transcript – Chapter 9 of 10 – The Patents

1:30:18 – 1:39:07 – Interactive sourced transcript

(Note: this page of the transcript does not contain the Dr. Chen sections, which was recently added to the project in 2011 for the Documentary Channel & Netflix airings. We will update soon.)

ON SCREEN TITLE CARD:
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.

NARRATOR (reading from highlighted sections of an internal NCI memo, 10/31/91): 
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.”
[SOURCE: 11/15/91 Letter and 10/30/91 Review of Brain Cancers Treated by Burzynski by the NCI]

NARRATOR (reading from highlighted sections of US Patent #6,037,376): 
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…” [SOURCE: Patent #6,037,376 pg 1, 6 of PDF]

NARRATOR:
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.

NARRATOR (reading from highlighted sections of internal leaked NCI memo 4/29/93): 
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 of  Antineoplastons, our involvement has become an issue.
[SOURCE: NCI Internal memo 4/29/93 pg 2]

NARRATOR (reading from highlighted sections of US Patent #5,635,532): 
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].
[SOURCE: Patent #5,635,532 pg 1, 34 of PDF]

NARRATOR (reading from highlighted sections of numerous USA DHHS Patents on Antineoplastons): 
In March of the following year, America files it’s most extensive updated Antineoplaston patent to date, spanning one hundred and eleven pages. [SOURCE: Patent #5,605,930]

Seven months later, they file a fourth one. [SOURCE: 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 patent 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.

NARRATOR:
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. [SOURCE: FDA Deputy Commissioners]

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. [SOURCES]

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 eleven copy-cat patents on Antineoplastons AS2-1. [SOURCE: The patents sourced above show their “approval date” and “filing date”]

STANISLAW BURZYNSKI – on camera interview: 
And as we know, all of this was being done based on the fact that the United States, which is the National Institutes of Health, together with a pharmaceutical company, which is Elan Pharmaceuticals, was trying simply to steal my invention. That’s what they wanted. It’s not that we had a 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 high-ups at the FDA to conspire with the pharmaceutical company so that they could steal the invention from me and get it, because it was good.

That’s the whole story.

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 them. So that’s why they attempted to wipe me out financially, to put me in prison, to attack me from every possible angle: FDA, which is the federal government, state government… to be able to steal my invention. That’s the real thing from the National Cancer Institute and Elan Pharmaceuticals.  They failed. We survived, and we continue to move forward.

NARRATOR (reading from highlighted sections of US Patent #5,605,930): 
These patents are full of useful information. Aside from noticing their blatant infringement, “Compositions and Methods for Treating and Preventing Cancer” [Pg 1], using the distribution of  Antineoplastons AS2-1’s ingredients. [pg 71] 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. [pg 49] They also point out how Antineoplastons can also be used as a cancer preventative. [pg 56]
[SOURCE: US Patent #5,605,930 pg 1, 49, 56, 71]

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.” [SOURCE: US Patent #5,605,930 pg 56]

Dr. JULIAN WHITAKER – on camera interview:
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 he could not fight the criminal theft of his discovery. Well, what about the ten million patients who have died of cancer over the last twenty years? The majority of them could have been saved if the government had not blocked the therapy that they new could save them.

Transcript – Chapter 10 of 10 – Conclusion

1:39:07 – 1:44:06 – Interactive sourced transcript

Dr. STANISLAW BURZYNSKI – on camera interview: 
The entire approach is totally wrong. It’s based on the microscopic diagnosis of cancer which is about one hundred and sixty years old. Without really looking at what is causing cancer, without looking for the genetic signature of the cancer—the technology in this area is developing, it’s available today if somebody would like to use it he can have at least some idea of what is ”the best to use for this patient”.

But the doctors are uniformly resistant against it, they don’t want to hear about it, they just use the combination of medicines in which they have learned by heart, and they know that that’s what they should use for everybody. Terrible waste, waste of resources, a terrible waste of human lives because in the meantime these patients obviously will not respond and they could respond if they would be given good medicine. Terrible waste of resources from the large insurance companies, as they will obviously pay for very expensive regimens which are going to fail, but at the same time when you try to select what is the best medicine for a patient based on their genetic signature they may not pay you, because they say “no, this medicine is not yet FDA approved, and it shouldn’t be used.”

It’s a totalitarian approach: everybody’s the same, everybody should receive the same medical regimen, and don’t you dare look at somebody as an individual—treat everybody the same way.

It’s good for the pharmaceutical companies because they will make billions of dollars, good for doctors who don’t want to learn much because they need to learn medicine by heart, and they can use the same thing all over again for a number of years. But of course bad news for patients who are going to have adverse reactions and very few of them will have real good results. That’s a problem.

Dr. JULIAN WHITAKER – on camera interview:
True progress in medicine has always, without exception, been violently resisted by medical authorities who cling to the beliefs of their time.

In 1840, Ignaz Semmelweis, an Austrian obstetrician noted that over 20%, that’s one out of five, women giving birth in the hospital died four to six days later of puerperal fever. These women were then autopsied in the basement of the hospital. And the doctors who performed these autopsies wore no gloves, can you imagine that? Believe it or not, they then would leave the autopsy room and go straight to the delivery room to assist other births without even washing their hands.

Then Dr. Semmelweis’ good friend and fellow physician accidentally cut his finger while he was doing an autopsy. In six days, this doctor died with the same signs and symptoms of puerperal fever. All of the sudden Semmelweis knew, he realized that the doctors were transferring the disease from the autopsy room to the delivery room, and he urged his colleagues to simply wash their hands. For this unforgivable sacrilege, he was drummed out of the medical profession and he died in an insane asylum. [SOURCE: Ignaz Semmelweis Wiki]

Now today we have the same kind of arrogant commitment to belief, but with cancer treatment we have a trillion-dollar business built on those beliefs. So if you think Semmelweis had a problem, just imagine the problem Dr. Burzynski faces.

There was no money involved in “hand washing” vs. “non-hand washing”.

Dr. STANISLAW BURZYNSKI – on camera interview: 
The smear campaign against us continues, from good doctors, from the American Medical Association, from the American Cancer Society. Despite of the fact that it should have stopped a long time ago.

The fact that we are permitted to enter Phase 3 trials means that the treatment already shows 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.

ON SCREEN TITLE CARDS:

In 2009, Phase II FDA-supervised clinical trials of Antineoplastons successfully came to a close. Phase III trials are the third and final phase before reaching FDA approval. These trials could being worldwide in 2010, barring the ability to raise the money to fund them.

The FDA has officially mandated that some patients participating in these Phase III trials also be subjected to radiation treatment while simultaneously receiving Antineoplaston treatment—claiming it would be “unethical” not to do so.

It is simply a matter of time before Antineoplastons and other forms of gene-targeted therapy will begin to replace chemotherapy and radiation for the treatment of most cancers. [SOURCE: B Healy US New World Report 2008]

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

All original documents and sources used in this film, plus much more additional information will be openly available for you to obtain and research for yourself at: http://www.burzynskimovie.com [SOURCE]

ON SCREEN TITLE CARDS (continued):
Written, directed, and produced by Eric Merola

ENDING CREDITS:
Special thanks to Stanislaw Burzynski, MD, PhD for his generous cooperation in allowing us into his busy life to make of this film.

Special thanks to Julian Whitaker, MD 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, and Carolyn Powers for her tireless hours spent in Dr. Burzynski’s extensive records rooms locating many of the documents presented in this film.

[ENDING CREDITS CONTINUE]

For more info on the Burzynski: Cancer Is Serious Business Documentary Film Series & Review visit www.burzynskimovie.com

In the USA you can watch it free on NETFLIX, iTunes, Amazon On Demand, or obtain the DVD from AMAZON or the producers.

More about the director, Eric Merola

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