Burzynski Page #5

consultants for drug companies.

The FDA behaves as though the pharmaceutical

industry is its user, not the public.

In 2010, the fee revenue paid by the pharmaceutical industry to the

FDA has risen to over a half a billion dollars-annually.

PhRMA now pays over $14 million per application for most cancer

drugs submitted to the FDA-to ensure a timely approval.

It's important to understand that neither Congress or the FDA had

requested this new fee structure to occur.

Instead, PhRMA itself went to Congress and imposed these

new fees onto the FDA,

in essence purchasing the FDA's drug evaluation department

from both the government and the public.

In a 2007 health policy report, sponsored by Pfizer,

supporting the renewal of these user fees, they revealed...

... that the median review time for priority drugs-

those for serious life-threatening diseases such as cancer,

was sped up from 21 months in 1993 to 6 months in 2004.

Dozens of cancer therapies have been reviewed and

approved within 3 or 4 months.

Meanwhile, Dr. Burzynski, his patients, and other

supporting scientists have made

every conceivable effort to get the FDA, and thus the government,

to cooperate in the research, review and approval

of Antineoplastons since 1977.

We're talking with Dr. Stanislaw Burzynski who is a

medical doctor and has a PhD.

He has done some experimental work in cancer treatment,

and has been conducting some very interesting studies,

which have been backed up by 4 and a half years of research.

we have here with us two patients who appear to be in

different states of remission

We began talking about the medical community's

acceptance of what you are doing.

How is your research funded?

In the beginning, my research was funded by the National Cancer

Institute, and from Baylor College of Medicine.

After I decided to open my laboratory, the only money

available to me for my research was bank loans,

patient fees, and payments from health insurance companies.

Could you stand for just a minute

Dr. Gardner-this is Dr. Harold Gardner.

Is there anything you find controversial here?

Does his treatment have a good scientific

hypothesis, and legitimate research behind it?

As the science of investigation goes, Dr. Burzynski's

studies have been very professional.

His studies are as credible as most medical research centers

like Wayne State Medical Center and The University of Michigan

Medical Center which I have a relationship with directly.

The controversy is not in his approach

to cancer therapy. Instead, the controversy is in his

approach as a cancer treatment organization.

We have to understand that much of the medical and hospital

industry operates as a very closed industry,

and if you have ideas that might jeopardize that economic base,

you will fall into disfavor very quickly.

That is an incredible statement that you just made.

I have been involved with many patients who have chosen

options in Europe, and in Canada,

and those options are not available in this county because of economic

and organizational reasons, not because of scientific reasons.

Wow.

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

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 under the laws of the state of Texas.

However, Dr. Burzynski would not be legally allowed to introduce

or deliver Antineoplastons into interstate commerce.

Which means, he had to keep his activities only within the state

of Texas to avoid breaking any federal laws

As long as he did this, his actions were not within the

regulatory authority of the FDA.

However, once word began to spread that Dr. Burzynski was

successfully treating what was once considered

terminal incurable cancer patients

people began traveling from all over the county

to receive Antineoplaston treatment.

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 tying 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 taxpayers money to travel a long distance,

like from Houston to California

to convince our patients who were

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.

This was a very unpleasant investigation,

they were tying to convince me again to stop

my research and to stop treating patients.

After about two years of going back-and-forth

and being called to the board

-finally they proposed to me that I should present to them

a number of cases of patients who benefitted from my practice.

They informed me that such medical records would be reviewed by

expert oncologists

and if they are satisfied that I am not harming patients

and the patients are benefitting 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.

In 1986, Dr. Burzynski agreed to present to the Texas State

Board of Medical Examiners forty cases of various types of

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