Timecode: 1:13:52-1:34:18

The National Cancer Institute vs. Stanislaw Burzynski, MD, PhD

While all of this was taking place, Burzynski knew that the easiest way to keep the government from putting him out of business or in prison, was to partner with an established pharmaceutical company.

An interest was shown from Japanese pharmaceutical company “Chugai”,

…and the Italian pharmaceutical company “Sigma-Tau”,

…but both deals eventually evaporated likely due to the “rapport” developed so far between Antineoplastons and the FDA. Being an “issue, indeed”, and were unable to verify the likelihood that they could openly and effectively work with the FDA.

Then, by 1990, it seemed that Burzynski’s luck had finally changed. Burzynski has apparently treated the sister-in-law of the Chairman and CEO of Elan Pharmaceuticals.

Elan enthusiastically drafted a letter of intent, stating they would aggressively pursue the filing of 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.

In the midst of closing this deal with Elan, more good news emerged. Dr. Dvorit Samid: a scientist and medical professor from Maryland who Burzynski had hired to further study Antineoplastons, managed to present her work at an oncology symposium in Switzerland, which landed her and Antineoplastons a cover story in a 1990 issue of “Oncology News”.

DR. STANISLAW BURZYNSKI – 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.

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.

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

NARRATOR (reading from highlighted portions of letter from Elan):
Elan has significant doubt as to whether the active substances comprising of Antineoplastons have patent protection, thereby rendering an agreement meaningless.

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 patents, but don’t patent this because you will never get a patent for that.” But this is the least important ingredient of Antineoplastons.

While this was an odd turn of events, more good news continued to pour in. It was in October 1991 when Dr. Nicholas Patronas led the National Cancer Institute on their site visit, the very same site visit Dr. Patronas would later base his testimony when defending Burzynski against the Texas Medical Board.

This site visit not only confirmed that Antineoplastons were curing what was previously considered incurable brain cancer, but, it garnered their interest in conducting a confirmatory trial under Division of Cancer Treatment sponsorship at the National Cancer Institute.

These trials involved most of their top experts, including, Dr. Michael Friedman: the Associate Director of the Cancer Therapy Evaluation Program. In a memo addressed to his director, Dr. Friedman wrote:

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.”

The National Cancer Institute’s “Decision Network” then convened, and gave the green light to conduct government-sponsored clinical trials of Antineoplastons.

DR. STANISLAW BURZYNSKI – 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.

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.

LI- CHUAN CHEN, PhD National Cancer Institute Scientist 1991-1997 on-camera interview:
In 1994, I started working for Dvorit Samid. She did not let me know that those compounds were originally from Dr. Burzynski. She just said “phenylacetate” and she showed me all of the published articles about phenylacetate, and its analogs and their anti-cancer activity.

It was quite amazing in the lab, because if you find a compound that has anti-cancer activity, and then you find a bunch of analogs, it’s like finding a pile of gold. So people would think and they’d say: “patents”, “patents”, “patents” that kind of thing.

With Dvorit, under her leadership, we found a lot of biological activities in these compounds, that have anti-cancer activity. The scientists at John Hopkins Cancer Center tried to patent these compounds but of course Dvorit was working with Elan Pharmaceutical company at that time, so the people at Johns Hopkins didn’t have any chance of patenting those compounds.

It is interesting that Dvorit would complain in the lab, saying that “these guys tried to go behind her back and patent these compounds.”

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.”

LI- CHUAN CHEN, PhD National Cancer Institute Scientist 1991-1997 on-camera interview:
In 1995, I was still with Dvorit in her lab, but I smelled that something wasn’t right. The first paper that Dvorit published about phenylacetate, if you look at the “methodology” section, there’s a “BRI” abbreviation. She got her materials from the Burzynski Research Institute – Houston, Texas. But it didn’t say “Burzynski Research Institute”. For us as scientists, it’s a dishonest practice.

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.

LI- CHUAN CHEN, PhD National Cancer Institute Scientist 1991-1997 on-camera interview:
Phenylacetate used by itself has very little clinical effect against cancer.

DR. STANISLAW BURZYNSKI – on camera interview:
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.

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.

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.”

NARRATOR (reading from protocol documents and 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.

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.

So they used this as an excuse to go behind Burzynski’s back, again, and take it upon themselves to drastically alter the protocols.

NARRATOR reading from highlighted sections of a letter from Dr. Burzynski to 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.”

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.”

NARRATOR reading from highlighted sections of a letter from Dr. Burzynski to 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.

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 (ABC):
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 (ABC):
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.

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 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.”

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.”

NARRATOR (reading from highlighted sections of letters from Dr. Michael Friedman of the NCI to Dr. Burzynski):
Burzynski responds: “Your letter of June 6th conveys pessimism? My letter conveys outrage. Patients were admitted against admission criteria, their treatment was discontinued, and their lives were jeopardized for frivolous reasons. In spite of your promise we never received any detailed data on these patients. There must be a reason why you are afraid to provide us with complete copies of medical records.”

Well, there was a very good reason why Dr. Michael Friedman was afraid to provide Burzynski with complete copies of these patient’s medical records:

DR. STANISLAW BURZYNSKI – 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.”

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 oof 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.

DR. STANISLAW BURZYNSKI – on camera interview (VO):
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.

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.

LI- CHUAN CHEN, PhD National Cancer Institute Scientist 1991-1997 on-camera interview:
In the past, when the National Cancer Institute or it’s assigned entity is conducting a clinical trial involving an alternative cancer therapy they always alter the protocols and let it fail, to discredit the therapy. But this time the pharmacokinetic data shows that they didn’t do it right. And most scientists will not look at that carefully. Because “papa is telling you something and you don’t question him.”

Continue To Chapter 9 (1:13:52-1:34:18)

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