Burzynski Page #9

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 federal prison, and $18,500,000 in fines.

Not to mention what would happen to his patients.

He is their last chance for life

but now the federal government is issuing a death sentence

for the patients of this cancer doctor.

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.

I believe that most of these 300 people will die within

a short period of time if the treatment is stopped.

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.

Our first witness is Mariann Kunnari, is that correct?

Yes, that's correct.

From Aurora, Minnesota.

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 was diagnosed with a brain tumor the size of a golf ball.

The surgeon removed 75% of his tumor,

and the remaining 25% was diagnosed from

a biopsy as a malignant,

very aggressive medulloblastoma brain tumor-

one of the most deadly forms of brain cancer.

The doctors told us Dustin had only a few months to live.

The first treatment offered us was radiation.

But the radiation doctor told us that at his young age,

Dustin would become a vegetable,

and it would only extend his life for maybe a few months.

The next doctor wanted us to enroll Dustin 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 traditional treatment that would have kept him alive,

with such good quality of life.

FDA Commissioner David Kessler loves to grab headlines

as a man who loves children so much

he wants to protect them from the ravages of smoking.

If Dr. Kessler loves children so much,

why have he and his agency been trying so hard to cut off

my son's last hope for life?

Without this treatment, my son will die.

This is a photo of Dustin Kunnari at four years old in 1996.

This is a photo of Dustin Kunnari at eighteen years old in 2009.

His brain cancer never returned.

Next, Food and Drug Administration Commissioner, David Kessler.

David Kessler talk about new guidelines released today by the FDA,

that could quicken the time cancer drugs spend being tested,

and the amount of time it takes the FDA to approve them.

American cancer patients from now on, will have faster

and easier access to more promising cancer therapies.

Here is the essence of the importance of each

of the President and the FDA's four proposals:

First:
for patients with refractory, hard to treat cancer, instead

of requiring evidence of clinical benefit, such as survival-

the FDA will rely on objective evidence of partial response

such as tumor shrinkage as an initial basis for approval.

This will allow us to rely on smaller, shorter studies

for the initial approval of cancer drugs.

The second proposal: we will expedite the availability of promising

medications that have been approved in certain other countries.

Third:
We will include representatives of cancer patients in

FDA's "Cancer Advisory Committees"

and thereby make sure that their views are heard-

when it comes to recommending

approval or non-approval of cancer drugs.

and fourth:
we will eliminate unnecessary paperwork

that used to delay or discourage cancer research

by non-commercial clinical investigators.

I'd be happy to take a few questions.

Will the FDA's initiatives that you announced today

expedite the current review of Antineoplaston treatment?

The FDA's initiatives will allow the agency to

rely on smaller trials with fewer patients.

If there is evidence of partial response in clinical trials-

I do not want to get into any particular type of treatment.

Let me point out that the research needs to be part of clinical trials.

We will accept less information up front. We are going to

require further study after approval because the science has matured.

The important point is that information needs to be gathered

through scientific means-through clinical trials.

That's a very important point.

You can't just use an agent here or there,

you have to use it as part of a clinical trial-

so we can get information as to whether the drug works.

Will patients who have taken other forms of cancer treatments,

like chemotherapy or radiation treatments, be allowed to

participate in clinical trials for Antineoplastons?

The FDA has many approved clinical

trials for patients with Antineoplastons.

What are Antineoplastons for the layman here?

Again, I really do not want to focus on any single cancer treatment.

They relate to compounds that are being used

and promoted by a doctor in Texas.

We are committed to providing expanded access and availability to

American patients for any drug there is reason to believe may work.

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 2 clinical trials.

Basically we filed and received permission from the FDA

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