Who Decides:
The Parents or the FDA?
by Michael Evers
April 4, 2000
At first glance, Thomas Navarro looks like any other
healthy four-year-old boy-a veritable fireball of energy
and activity, running on all cylinders all the time.
His close- cropped haircut and smooth round head resemble
a large cue ball, begging to be rubbed and patted, until
closer inspection reveals the barely-healed six-inch
scar running from the top of his spine up along the
back of his skull.
Thomas's brain tumor is gone now, surgically removed
last September. Questions remain, however: will it come
back, and what should be done now to prevent such recurrence
and maintain little Thomas's chances of living a normal
and healthy life?
The U.S. Food and Drug Administration (FDA) says it
has the answer: "preventive" chemotherapy and radiation.
Thomas must take both treatments for several months
and if tumors return to his battered brain, then, and
only then, will the FDA allow him to be treated with
an "investigational" therapy.
Informed Parents Denied
Treatment of Choice
Thomas's parents, after an exhaustive review of current
medical literature and consultations with numerous authorities
from around the country, believe another approach should
be tried first-antineoplaston therapy offered by Stanislaw
Burzynski, M.D., Ph.D., at his Houston medical clinic.
They have petitioned the FDA for nearly four months to
let them and their son choose the Burzynski option first
instead of subjecting Thomas to debilitating chemotherapy
and radiation. So far, the agency has steadfastly refused
the Navarros' request.
Who Decides?
It comes down to who decides: The parents, or the FDA?
An answer to that question was proposed Wednesday, February
16, when Rep. Dan Burton (R-IN) and a handful of his colleagues
introduced the Thomas Navarro FDA Patient Rights Act (H.R.
3677). At a news conference in front of the U.S. Capitol,
Burton was enthusiastically joined by Republican presidential
candidate Alan Keyes, who has taken up the Navarros' case.
Land of the Free?
"We're fighting for our son's life," pleaded Thomas's
mother, Donna. "And I need your help to save his life,
because he deserves it. . . I should not have to go to
another country to seek treatment that I think that my
son deserves. This is America! This is freedom of choice!
This is quality of life! And yet the FDA is denying this
for my son. My son doesn't deserve this. . ."
Jim Navarro held back tears when he spoke of his son's
ordeal, stating "This could be any one of you." He vowed
to fight on with the aid of his new allies. "We are
not done, and we will not be done, until our son has
the freedom in the United States of America to be treated
by the doctors of our choice, and to receive the modality
of treatment that will allow him dignity of life and
quality of life."
Thomas Navarro FDA Patient Rights Act
The legislation proposed by Burton would bar the FDA from
placing clinical holds on investigational treatments like
antineoplastons just because the agency believes another
course of therapy is preferable, as long as the patient
or his or her parents declare in writing that they are
fully aware of such conventional treatments and yet are
willing to accept the risk associated with going forward
with an investigational approach. Essentially, Burton's
bill would let patients decide, not FDA bureaucrats.
"Americans should have the right to make their own
treatment choices," said Rep. Burton. "This legislation
would allow patients to make informed choices between
treatments, having the FDA as a partner in this process
instead of a dictator. Thomas's parents are reasonable,
loving parents who researched their options thoroughly
and found the best treatment option for their child-a
treatment that [legally can be shipped to doctors in]
Australia, Canada, the United Kingdom, Israel, Japan,
Switzerland, and the countries of the European Union,
and under clinical trial in this country."
Burton summed up the FDA's position: "They want [Thomas]
to go through and fail chemotherapy and radiation before
trying what his family sees as his best opportunity
for survival. If we continue to take this attitude regarding
access to clinical trials, then we will never have progress
and get real answers on other treatment options."
Michael Evers is a contributing writer to Natural
HealthLine. This excerpt was originally published February
18, 2000 at www.naturalhealthline.com. You can access
"The Thomas Navarro FDA Patient Rights Act" at http://thomas.loc.gov/.
Enter bill number "H.R.. 3677."
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