Government Reform and Oversight Committee
February 4, 1998
Ms. Mary Jo Siegel
Seven years ago, I was stricken with a fatal cancer, non-Hodgkins
lymphoma, for which no conventional cure yet exists. This
disease is treatable for periods of time with chemotherapy
and/or radiation, but the outcome is always death.
My husband Steve and I were devastated by my prognosis, but
determined to find a cure. Our research took us to top Iymphoma
specialists at esteemed medical institutions like UCLA, USC,
Stanford and the Dana Farber Cancer Institute in Boston. All
the experts confirmed our worst fear. With existing therapies,
my disease was incurable.
At Dana Farber, a ray of hope emerged with the recommendation
that I undergo an autologous bone marrow transplant. This
highly controversial procedure would require that I receive
extremely high-dose chemotherapy and as much radiation as
people who were within one mile of "ground zero" at Hiroshima.
I would lose my hair, experience severe nausea and vomiting,
and the threat of bacterial and viral infection would keep
me in complete isolation for 6 weeks. My quality of life,
post treatment, would be drastically diminished. From the
chemotherapy I would become sterile. There would be damage
to my heart, lungs, liver, kidneys, and bladder. Collateral
radiation damage would affect my eyes, salivary glands and
thyroid, with a greater than 50% chance that I would develop
leukemia if I were lucky enough to survive just 10 years.
I was frightened and suspicious because only a handful of
patients had survived this procedure with good long-term results.
One such person was the late Senator Paul Tsongas, who eventually
died of complications caused by the procedure.
Fortunately, we discovered the work of Stanislaw Burzynski
MD, Ph.D., who was treating advanced cancer patients with
a gentle, non-toxic therapy he had discovered. As I began
Dr. Burzyuski's antineoplaston treatment, my lymphoma had
progressed to stage 4 (there is no stage 5). Malignant tumors
were growing throughout my body. My bone marrow was infiltrated
and there was a large and growing tumor on the side of my
neck. After only 3 weeks on this medicine, that tumor disappeared!
Subsequent scans performed at UCLA showed continual reduction
in tumor size.
During antineoplaston treatment, my quality of life was excellent,
virtually free of side effects. I was an active and involved
mother, an absolute necessity when you are raising 3 teenagers.
More importantly, the drug stopped my supposedly terminal
cancer. Within 12 months I was pronounced in remission, not
by Dr. Burzyuski, but by the same lymphoma expert at UCLA
who had originally diagnosed me and told me I faced certain
death from this disease.
I went off treatment and remained in remission for 2 years,
when a follow-up scan revealed a possible return of the disease.
Immediately, Dr. Burzyoski prescribed a regimen of antineoplaston
capsules. Within 5 months I was once again in remission, and
have remained cancer free to this day.
That's the end of the good news. The tragedy is that our
government, namely the FDA, has been keeping what author Tom
Elias calls "the century's most promising cancer treatment"
from becoming widely available to cancer patients. The agency
has spent untold millions of taxpayer dollars in a systematic
attempt to harass, discredit, stonewall and even imprison
Dr. Burzynski.
As incredible as it sounds, in November 1995, FDA indicted
Dr. Burzyuski on 75 criminal counts, most having to do with
alleged technical violations of the Interstate Commerce Act
and none having to do with his practice of medicine or the
effectiveness of his drug. Dr. Burzyoski had been legally
treating patients under Texas State law for some 20 years
and not one patient in all that time had ever filed a complaint.
If Dr. Burzyuski had been convicted on all 75 counts, he could
have been sentenced to 290 years in a federal prison.
Are antineoplastons effective? Ask the FDA. Apparently it
believed the answer is yes, because it fought tenaciously
to keep the question of antineoplastons' effectiveness out
of the trial. Dr. Burzynski tried to make it a part of the
trial. Apparently, both the FDA and Dr. Burzynski believed
he could prove the drug works. FDA also fought to keep the
full truth from the jury by preventing Dr. Burzynski's patients
from testifying, while Burzynski asked the judge to allow
the patients to tell their stories.
In the end, Dr. Burzynski was acquitted on all counts. But
I ask you in Congress, and particularly my representative,
Mr. Waxman, how you can allow the FDA to squander taxpayer
money in an idiotic prosecution, the success of which would
mean the deaths of hundreds of cancer patients? FDA was unable
to find even a single patient to testify against Dr. Burzyuski!
Peter Barton Hutt, a former FDA Chief Counsel, has said "if
you beat the FDA in court, you have an angry FDA that is willing
to slit your throat". Indeed, while it lost the courtroom
battle against Dr. Burzynski, it continues to wage war against
him and his patients. The agency interferes in his practice
by telling him whom he can and cannot treat. With many types
of cancer, the FDA requires patients to have failed not one,
but two rounds of chemotherapy before they can be treated
with antineoplastons. In many cases the chemo has so ravaged
their immune systems, they literally have nothing left to
fight with and they die.
FDA forbids the use of steroids in the treatment of Dr. Burzynski's
lymphoma patients, even when they are needed to temporarily
shrink tumors and relieve pain, as in my own case. Because
I was on treatment prior to the FDA taking over his practice
of medicine, Dr. Burzynski was able to inject me with "Medrol"
to relieve pain and tightness in my neck caused by the tumor.
Now, however, the FDA is not concerned with patient comfort.
Their twisted logic dictates that good data collection outweighs
humane medical treatment.
The FDA demands that Dr. Burzynski's lymphoma patients stop
treatment if they have not achieved 50% tumor reduction within
6 months. The absurdity of this typically arbitrary FDA requirement
became clear when one Burzynski patient Frances Langham was
to be forced off treatment when she achieved a 44% reduction
after 6 months! She is lucky to be from Arkansas and politically
connected. She received a "special dispensation" allowing
her to continue treatment. But the FDA removed her from the
clinical trial, meaning that even if cured in the future,
FDA will count her as a "treatment failure" in detesting effective
Antineoplastons are! These treatment "restrictions" are only
applied to Dr. Burzynski's clinical trials, whereas lymphoma
patients involved in Idec Pharmaceutical's C2B8 and Elan Pharmaceutical's
phenylacetate trials do not have to meet these same treatment
criteria. Is it possible that FDA has a bias against Dr. Burzyuski
and his patients have to suffer as a result?
Who gave the FDA the right to plop God? Was it the intent
of Congress to give FDA the kind of power it exercises over
life and death with no accountability? By denying terminally
ill cancer patients access to antineoplastons, this agency
literally decides "who shall live and who shall die".
I have had to watch as children and adults suffer and die
as a result of FDA intransigence. Patients plead to be allowed
into antineoplaston clinical trials, but FDA says "no you
don't qualify." Shouldn't it be the doctor, in concert with
the patient, making these important medical treatment decisions,
rather than an FDA official who doesn't even know the case?
Clearly the FDA is denying these patients their freedom of
medical choice. Because conventional, FDA approved remedies
have failed to work for the majority of Dr. Burzynski's patients,
often their only choice is antineoplastons or death!
It's been 26 years since President Nixon declared the "War
on Cancer." Public expenditures now exceed 30 billion dollars
and private research and development funds must total at least
10 times that amount, yet the death rate continues its relentless
climb. It's time for a new approach to treating cancer. The
only way this will become reality is by allowing cancer patients
expanded access to new, experimental and innovative treatments.
Until we have a cure, all of it, conventional and alternative
is experimental!
Dr. Nicholas Patronas, chief of Neuro-Radiology at NCI, testified
under oath that antineoplastons are the most effective treatment
for brain tumors he has ever seen. Top oncologists have lauded
Dr. Burzyuski's work, including those at the University of
Washington and Georgetown University. Doctors and scientists
around the world eagerly await the approval of antineoplastons.
Dr. Michael Friedman, the current commissioner of the FDA
once wrote that "Antineoplastons deserve a closer look...the
human brain tumor responses are real." So why is FDA so determined
to impede the progress of a drug with such promising results?
5
Congressmen, we implore you to restore the right to choose
our own health care. You have the power to give us back our
freedom. Mr. Waxman, as your constituent I know you staunchly
support both the FDA and a woman's right to an abortion. But
can you really condone a government which grants a mother
the right to choose death for her fetus, while deriding a
dying cancer patient one last hope for life?
In his March 29, 1996 press conference, President Clinton
announced new initiatives to expedite the approval process
for innovative new cancer drugs like antineoplastons. Since
then FDA has bluntly stated that the President's initiative
has changed nothing. It's time for congressional oversight
to insure that mandate is carried out. The terminally ill
deserve the chance to win their personal war on cancer and
it's up to Congress to insure they have the weaponry with
which to fight. Thank you.
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