Burzynski Page #10
to proceed with 72 different Phase 2 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,
the FDA had to create a special
task force to be able to review these protocols.
For soft tissue sarcoma, there is a special protocol for that.
For 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.
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 trial moved forward.
"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 is the issue comes up at trial, it would be an
irrelevant, emotional, prejudicial and misleading concern."
The issue of whether Antineoplastons work may not
even come up during 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.
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 and injustice being done to
Dr. Burzynski, his readers sent in close to 18,000 checks in
small donations for Burzynski's legal defense.
The trial is expected to last about two months,
the jury will then decide whether Burzynski is a fraud,
or a medical pioneer.
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.
You voted to acquit?
To acquit, absolutely.
Not guilty. Not guilty
I voted for acquittal.
I voted my mind, and my heart...
I do not believe that Dr. Burzynski is a criminal.
...and I had voted to acquit...
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.
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.
I am appalled at the
Food and Drug Administration and their actions.
We're here today,
basically, to protest the witch hunt that's going on by the FDA.
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.
Please don't waste my money abusing the system
to make sure that you maintain your power.
The jury spent about three hours deliberating this house of cards,
leaving Burzynski acquitted of the final charge.
Every one of Dr. Burzynski's patients now,
every future Burzynski patient is and will be on a clinical trial.
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 tying 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.
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 tying 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.
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".
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
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