Burzynski Page #12

Institute with any Antineoplastons.

Dr. Michael Friedman told Burzynski:

"in response to your correspondence, one last time, we will revise

the protocol with regard to dose and schedule in compliance,"

"however, if you are unable or unwilling to provide the Antineoplastons

in the near future, we will pursue alternative sources to procure the

drug, or its active components, and will proceed.

Burzynski responded:

"l appreciate very much that you have finally decided to follow

my recommendation regarding dosage."

"But your final statements that you are ready to proceed with the

treatment with Antineoplastons without our participation

caught me by surprise."

"It is hard to imagine that a federal employee

would consider patent infringement."

Placing these ominous threats from Michael Friedman aside,

they finally managed to agree on a protocol.

The protocol was simple. Patients with tumors larger than

5 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.

"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."

The National Cancer Institute responds:

"sorry, but the amendments have been approved."

Burzynski fires back:

"Let me make perfectly clear that as the discoverer

and developer of Antineoplastons, and the individual with

nearly 20 years clinical experience using them,"

"it is my professional opinion that the drugs will not

produce substantial benefit in such advanced patients."

"As I have repeatedly informed you, the protocol that we are

currently using for such advanced tumors, requires

doses three times greater than that currently being used."

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.

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.

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.

We get the idea that the main interest

is to let these patients die rapidly,

and make sure that the treatment will never work.

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 tying 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.

"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 inquiries that may be related to the trials or

Dr. Burzynski are to be referred to the associate director:

Dr. Michael Friedman."

Friedman then taunts Burzynski:

"l must convey my deep pessimism.

We are in no way obligated to obtain your consent."

"Your insistence on dictating the manner in which

we conduct or review these clinical trials is both

presumptuous and inappropriate."

"The future of these trials rests entirely with the NCI,"

"since our primary obligation is to the American public."

Burzynski responds:

"Your letter of June 6th conveys pessimism.

My letter conveys outrage."

"Patients were admitted against admission criteria,

their treatment was discontinued, and their lives were

jeopardized for frivolous reasons."

"In spite of your promise we never received any

detailed data on these patients."

"There must be a reason why you are afraid to

provide us with complete copies of medical records."

Well, there was a very good reason why Dr. Michael Friedman

was afraid to provide Burzynski with complete copies of these

patients' medical records.

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 in which we don't see with Antineoplastons,

the typical side-effect of Antineoplastons is dehydration,

which means elimination of the fluids, the patients are

losing a lot of fluid to the point where they have to drink

a lot of extra fluid.

We don't see increased fluid retention.

I was curious 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.

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.

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

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