Thursday, February 17 2000

© 2000 Houston Chronicle
WASHINGTON - A bill was filed yesterday to allow a Tucson boy whose parents don't want him to receive radiation and chemotherapy to be treated by Houston cancer specialist Stanislaw Burzynski's alternative therapy.
The bill was introduced as Texas' Child Protective Services department began investigating the family's decision not to use conventional medicine on their 4-year-old son's brain cancer.
The legislation would give patients ultimate authority in deciding whether to use drugs the Food and Drug Administration is investigating but has not approved. Under current law, the FDA makes that final decision based on what it says is best for the patient.
``Americans should have the right to make their own treatment choices,'' U.S. Rep. Dan Burton, R-Ind., said in announcing the legislation. ``This legislation would allow patients to make informed choices between treatments, having the FDA as a partner in the process rather than a dictator.''
An FDA spokesman, who said he had not seen the bill, yesterday repeated the agency's stance that ``there is no scientific and ethical justification for using a child in research when a proven, effective treatment is available.''
Burton was joined by the boy, Thomas Navarro, and his parents, James and Donna Navarro of Tucson, as well as a child successfully treated by Burzynski and a child visibly suffering the toxic effects of radiation and chemotherapy.
The FDA says Thomas must try radiation and chemotherapy without success before it will allow treatment by Burzynski, who uses a nontoxic alternative therapy called antineoplastons.
Also on hand was Republican presidential candidate Alan Keyes. He led a march from Capitol Hill to the Department of Health and Human Services to deliver a letter signed by himself, Gary Bauer, Steve Forbes, Orrin Hatch and John McCain calling on Secretary Donna Shalala to intervene on behalf of the Navarros. Texas Gov. George W. Bush has expressed similar sentiments.
But despite Bush's support, the Texas agency has begun investigating a report of ``medical neglect'' against the Navarros.
Confirming that it is trying to contact the Navarros, Harris County CPS spokeswoman Judy Hay said state law requires the agency to evaluate any report it receives.
After surgery to remove Thomas' medulloblastoma in September, the Navarros opted not to do chemotherapy and radiation upon learning its side effects in children can include not just nausea, fatigue, hair loss and loss of control of bowels but also hearing loss, spinal growth deficit, hypothyroidism and mental retardation.
After extensive research they decided they wanted Thomas treated by Burzynski, whose experimental drug - synthesized versions of peptides found in blood and urine - made him a folk hero to some patients but a villain to the medical establishment, which went to court to stop him. Though Burzynski was acquitted, he is only allowed to prescribe antineoplastons in FDA-approved clinical trials.
Michael Cohen, a lawyer specializing in health care and regulatory affairs, said the bill, named the Thomas Navarro FDA Patient Rights Act, would ``filter down'' and have a significant effect on the medical regulatory system.
But its future is questionable.
Past legislation to liberalize access to non-FDA-approved treatment died quietly, and even though the bill has an emotional appeal and is simple to grasp - it simply amends the Food, Drug and Cosmetic Act to restrict the FDA's authority as long as patients are aware of the risks - the Navarros know time is not on their side.
After all, without follow-up treatment to surgery to remove the brain tumor, disease recurrence kills 90 percent of patients in one year and 100 percent in two years. James Navarro already has gone from hopeful two weeks ago to frustrated Wednesday.
``I'm tired of negotiating behind the scenes,'' Navarro said. ``Men of evil negotiate behind the scenes. It's time to bring this out in the daylight.''