Saving Thomas Navarro
updated 03/20/2000 AT 01:00 AM EST
•originally published 03/20/2000 AT 01:00 AM EST
His parents, James and Donna Navarro, don't mind Thomas's obsession a bit; in fact they savor all his youthful enthusiasms. For the brown-eyed boy at the wheel is caught up in an all too real race for his life, one that has pitted his family against the federal government, forced them to leave their Tucson home for fear of losing custody of the boy and injected Thomas, marginally, into the presidential primary campaign.
Despite his apparent vitality, Thomas suffers from a virulent type of brain cancer. Without chemotherapy and radiation, doctors say, he will almost certainly die within a year, two at the most. But after poring over medical texts, journals and Web sites, the Navarros concluded that the side effects of such treatment could leave Thomas profoundly brain-damaged—a risk they aren't willing to take. "I know what it would do to Thomas," says James, 46. "Here's a happy, spirited, intelligent child. I would rather have my son as my son and remember him like this."
Which is not to say that the Navarros plan to stand by and watch Thomas die. Instead they want to place him in the care of Dr. Stanislaw Burzynski, 57, a controversial Houston physician whose experimental therapy using gentler drugs he calls antineoplastons has made him a hero to hundreds of cancer patients but anathema to the Food and Drug Administration, which has battled against him in and out of court since 1983. Calling Burzynski's methods unproved, three years ago the FDA restricted his treatment to patients who have exhausted all other options. And now the agency, which says the Navarros' fears of side effects are exaggerated, is threatening to shut down his clinical trials should he treat Thomas before the boy has gone through the gamut of conventional therapies. Still, James Navarro won't yield. "This isn't about good doctors versus bad doctors," he says. "It can be summed up in two words: Who decides?"
For some prominent Republicans, the answer is unquestionably the Navarros. Trumpeting the boy's case as an example of big government interfering in decisions that belong to the individual, quixotic presidential hopeful Alan Keyes invited Thomas and James to a March 2 debate in Los Angeles and sent a letter on the Navarros' behalf, cosigned by Sen. John McCain, to Health and Human Services Secretary Donna Shalala. "These are parents who have tried to behave with the greatest responsibility," says Keyes. "It's just not right."
Not surprisingly, Burzynski agrees. "The choice of treatment should be a matter between a patient and his doctor," says the internist, who has treated a dozen children like Thomas with his antineoplaston therapy, an intravenous cocktail of peptides (chemicals derived from amino acids) that, he says, "switches off" the genes that tell cancer cells to grow. According to his own study, eight of those young patients are still alive today, four years after their treatment.
Yet the FDA says it's far too early to evaluate Burzynski's technique and argues that Thomas's parents are neither qualified—nor emotionally equipped—to choose his course of treatment. "When you're the parents, you're so vested you can't see the whole picture," says Dr. Dianne Murphy, associate director for pediatrics at the FDA's Center for Drug Evaluation and Research. "You need someone who is removed from the situation." Though there are conflicting studies about the success and side effects of chemo and radiation in cases like Thomas's, Murphy says the child would have a 70 percent chance of surviving at least five years. "And the risks would be minimal," she stresses. "At the worst, a 10-to 20-point loss in IQ. This is a child who has much hope."
Until last summer, that went without saying. A chatterbox, never far from his little brother Patrick, 3, or Che, his pet Chihuahua, Thomas Navarro was an exuberant preschooler. So in late August, when he began suffering headaches and bouts of vomiting, his parents, who run a law-enforcement-supplies business, assumed it was just a virus that would play itself out. When it didn't, they took Thomas to the family doctor. Nothing could have prepared them for the news. "I saw the doors swing open, and Donna came flying through," recalls James, who was in the waiting room. "She just screamed at the top of her lungs—'Jim!'—and she collapsed."
An MRI confirmed the diagnosis of medulloblastoma, an aggressive form of brain cancer, and two days later surgeons removed a golf-ball-size tumor from the base of Thomas's brain. The operation left the boy temporarily unable to see, speak or walk. Says James: "He was like a 4-year-old newborn."
A former U.S. Army medical assistant, Donna, 33, used flash cards to improve Thomas's speech, encouraged him to walk and took him to physical therapy. James, meanwhile, learned all he could about the disease. By the time they arrived at the Tucson Medical Center for their first oncology consultation, the Navarros were ready to endure whatever treatment doctors advised. But soon their hopes began to flag. "You see these little kids with portable IV trees, no hair, veins sticking up all over their heads; ashen gray, dark, lifeless eyes," James recalls. "I said, 'Donna, this isn't helping these kids, it's killing them.' "
Even so, the couple listened as Dr. Baldassarre Stea, Thomas's oncologist, explained the side effects of radiation—nausea, vomiting, hair loss, fatigue. Then they signed a consent form. It was only afterward, says James, that they learned of direr risks: blindness, hearing loss, sterility and loss of IQ. (Dr. Stea was unavailable for comment.) Frantically, the Navarros immersed themselves in the search for an alternative treatment. While scouring the Internet, James came across Burzynski's Web site. "What caught my eye," he says, "was that he had treated 12 kids with medulloblastoma and had a much greater success rate than conventional medicine, without the side effects." Statistics can mislead, of course—much depends on the condition of each patient. But one of Burzynski's apparent triumphs is 8-year-old Dustin Kunnari of Aurora, Minn., who also suffered from medulloblastoma. In 1994 and '95 his parents, Jack, 34, and Mariann, 36, brought Dustin to Burzynski rather than subject him to radiation. "Dustin," says his father, "has been in complete remission ever since, the picture of perfect health."
In fact, the Polish-born Burzynski has impressive credentials. The son of a language professor, he earned a medical degree with honors from the Lublin Medical Academy in 1967. Later, working toward his Ph.D. in biochemistry, Burzynski observed a peptide deficiency in the blood of cancer patients and wondered if there was a link between the deficiency and the disease. In lab tests, he says, he isolated certain peptides from human blood and applied them to cancer cells to inhibit their growth without harming normal cells. In 1970, Burzynski emigrated to the U.S. with his wife, Barbara, 59, a gynecologist. Settling in Houston, he taught at the Baylor College of Medicine, where he continued his cancer studies, patenting each of the newly isolated peptides, which he named antineoplastons—from neoplasm, Greek for tumor.
In 1978, with the first of what would amount to more than 120 worldwide drug patents to his name, Burzynski set up his own cancer clinic. Word of his work had spread through medical circles, and patients soon sought him out in Texas, where he was authorized by the state medical board to administer his drugs. When the FDA discovered he was also treating patients out of state, the national agency ordered Burzynski to subject his drugs to regulated clinical trials. By 1983 the FDA was still dissatisfied with his results, so it sought an injunction to keep him from treating patients.
The injunction was denied, but the FDA's action precipitated a series of court clashes. In 1995 the Justice Department filed a 75-count indictment against Burzynski, on the FDA's behalf, charging him with, among other things, illegally selling his drugs across state lines. In 1997 he was acquitted of 35 charges, and the other 40 were dropped. But the cloud has not lifted entirely. Around the same time, U.S. District Judge Simeon T. Lake III ordered Burzynski to begin clinical trials of his treatment, and the Texas Medical Board placed him on probation. The doctor is also facing a lawsuit brought by a Lockport, N.Y., couple over the death of their 10-year-old daughter in 1998. (Burzynski dismisses the action as a "nonsense case.") Moreover, he has come under fresh fire from colleagues who consider the methodology of his current trials—involving 92 patients—at best, sloppy. "They're just appalling," says Dr. Henry Friedman, a neuro-oncologist at Duke Medical Center in Durham, N.C. "They were not conducted in a way in which one could interpret the results." Dr. Roger Packer, chairman of neurology at Children's National Medical Center in Washington, D.C., is equally scathing. Burzynski, he says, is "giving hope where there isn't hope."
The Navarros prefer to believe that there is. They've talked with dozens of Burzynski's patients, along with the parents of children in Thomas's condition who had radiation and chemotherapy and emerged profoundly retarded. Despite all the criticisms, Burzynski "is the only doctor we have come across who was willing to show us his patients," says Donna Navarro. "He was very open and forthright, and no one else was."
Still, some doctors believe that while holding out for a treatment they have not been able to obtain, and allowing Thomas's condition to deteriorate, the Navarros are endangering the boy's life. Last fall, Dr. John Hutter, Thomas's oncologist, filed charges of medical neglect against the couple with Children's Protective Services in Arizona. Determined to get Thomas the treatment they wanted, the Navarros moved to a Houston hotel room, where, four months later, they remain.
But they are not alone. On Feb. 17, U.S. Rep. Dan Burton (R-Ind.) introduced legislation in Thomas's name that would restrict the FDA's authority to bar any treatment providing a patient or his guardians are aware of the risks. With time running out, the Navarros consider the bill a last chance. "Every moment with Thomas is precious," says his father. "Every second. There are times when I just sit and watch him sleep and lock him into my memory."
Patricia B. Smith in Houston, John Hannah in Los Angeles and Linda Kilian in Washington, D.C.