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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 You can access "The Thomas Navarro FDA Patient Rights Act" at Enter bill number "H.R.. 3677."

Who Decides: The Parents or the FDA?