The Thomas Navarro Story, Part One

Pat Smith
Bulletin Staff

On September 16, 1999, life was pretty good for James and Donna Navarro. Their Tucson, Arizona based retail law enforcement supply company was prospering, and their kids, four-year-old Thomas and two-year-old Patrick were happy and mostly healthy.

But Thomas had been having headaches and they seemed to be getting more severe. Their pediatrician told them not to worry, but when the boy started vomiting repeatedly, the Navarros took Thomas back to the doctor. On September 17, the Navarro's world fell apart.

After taking Thomas for tests, they received a dread diagnosis; Thomas had medulloblastoma, a rare, aggressive form of brain cancer that, if left untreated, is 100% fatal. On September 19, Thomas had surgery to remove the tumor which was nesting at the base of his brain. The surgery left the child with temporarily impaired sight and motor skills, but at least it bought the family some time. James, a "take-charge" sort, immediately went in search of any information he could get his hands on; he wanted to know everything about medulloblastoma and all the available treatments so he could make informed choices for his son's postoperative care.

What he found didn't make James very happy. In study after study, he read how full brain radiation might halt the cancer's growth, but at a terrible cost. With fear gnawing at his heart, James read the results of an 11-year study at St. Jude Children's Research Hospital in Memphis, TN, published in the December, 1999, Journal of Clinical Oncology.

51% of the 29 children in the study were still alive at five years after the treatment, but all were profoundly retarded and suffering from a host of other horrible, permanent side effects from the radiation and chemotherapy. Only 19 of the 29 children survived more than two years, and the paper acknowledged that the ten deaths may have been caused at least in part by the toxic chemotherapy and full craniospinal radiation the children were subjected to.

The side effects of radiation noted in the study led the researchers, internationally recognized pediatric oncologists and neurologists, to state: "Although radiation therapy clearly improves overall survival, the late toxicity is significant and sometimes devastating. The dilemma of trying to choose between using potentially curative, multimodality therapy as opposed to concerns about long-term quality of life can be a painful choice for families and health care providers alike." The researchers came to this conclusion: "All the patients in this series were treated with postoperative chemotherapy and subsequent craniospinal radiation, and all had significant neuropsychologic injury."

In other words, the full craniospinal radiation and chemotherapy Thomas' doctors were recommending might or might not cure the cancer, but it definitely would turn James and Donna Navarro's bright, happy little boy into something they couldn't imagine. The awful side effects were not just the stuff of possibility; what they read in countless medical journals told them their son definitely would be retarded, sterile, his growth would be stunted, he would be bald for life and possibly deformed. His pituitary gland would be cooked, making him dependant upon uncertain hormonal and steroid therapy to regulate his body chemistry for the rest of his life. His kidneys and liver might shut down. He also might possibly be deaf, blind and motor impaired. His heart might stop, his blood vessels might become rigid and inflexible and burst. And that was just the short list.

James researched further, and was amazed to discover that neither chemotherapy nor craniospinal radiation had ever actually been approved by the FDA for use on pediatric patients. In multiple studies, James read how chemotherapy has little or no effect on slowing the growth of medulloblastoma. He discovered that full craniospinal radiation was considered a first generation treatment; based upon poor outcomes caused by the treatment, researchers were calling for modification of pediatric radiation protocols to reduce or eliminate some of its most devastating side effects.

Yet Thomas's doctors were insisting full craniospinal radiation combined with a toxic chemotherapy cocktail was the only acceptable treatment for medulloblastoma; none other was available. The then Navarros heard about Stanislaw Burzynski, M. D., Ph.D., a Houston doctor who had been running clinical trials of antineoplastons, a synthetically derived peptide which appeared to have good results against the type of brain cancer Thomas has. Even though there are more than a dozen children, former brain cancer patients, now alive and cancer-free as a result of treatment with antineoplastons, Burzynksi had been locked in a running battle with the FDA for almost 16 years, and the legal constraints imposed upon the doctor by that agency would not allow him to treat Thomas. When the Navarros heard this news, their second nightmare began.

After the Navarros refused to allow their son to be treated with chemotherapy and radiation, they traveled to Houston, thinking they would stay a week or two until they could work their way through the red tape and get Thomas enrolled as a patient with Dr. Burzinski. That week or two turned into eighteen months. For four of those months, the Navarro family was crammed into a tiny, two-room suite at a residential hotel near Burzynski's clinic, waiting futilely for permission from the FDA to treat Thomas with antineoplastons. It didn't come.

The Food and Drug Administration disagrees with the Navarro's decision to turn down radiation and chemotherapy for their son, and has tried to gain custody of the boy through Child Protective Services in both Arizona and Texas so that the therapy they are mandating can be administered. James and Donna Navarro would like to know the legal basis for the FDA's authority to take their son away from them and administer a treatment they consider to be cruel and barbaric.

As one law enforcement agency after another sought to remove Thomas from the Navarro's custody, the family was forced to go underground. Staying one step ahead of doctors and social workers who kept trying to grab their son, they went on an international odyssey to find answers.

During the almost two-years since they were told Thomas had brain cancer, the Navarros have lost their house, spent every penny of their savings and even shut down their business to devote themselves full time to their quest to get Thomas the treatment they feel is best for him. James still shakes his head in amazement when they thinks about what has happened to his family.

"How can a federal agency with no constitutional basis for police authority freely interfere with our right to make informed choices about medical care for our child?" he asks. "When you ask them where they got their authority, they show up with truckloads of paper and say, `Here. It's in here somewhere.' They bury you with legal speak and mumbo-jumbo while they're in the back room making the law giving themselves the authority to do anything they want."

Last Christmas, as Thomas's condition continued to deteriorate, the Navarros struck a bargain with the FDA. If they agreed to put their son through three rounds of chemotherapy, the FDA would agree to allow the boy into Dr. Burzynski's antineoplaston trials. Reluctantly, James and Donna agreed. Through the course of the chemotherapy, Thomas steadily declined as the drugs attacked his blood, his kidneys and his liver. At one point, doctors at New York's Beth Israel hospital where Thomas was undergoing treatment told James and Donna their son had just a few hours to live. His white blood cell count had been knocked so low by the chemotherapy that the doctors did not think the boy would recover.

Donna went back online and found some other families who had been through the same thing with their children and discovered that administering a high dose of a particular form of Vitamin A could jump start the production of white blood cells. Donna put four drops under her son's tongue and within a few days, he was sitting up in his bed and asking when they could leave the hospital.

Once Thomas was discharged, the Navarros contacted the FDA to find out when they could take Thomas to Houston to begin his antineoplaston treatments, but FDA authorities reneged on their promise to the family and once again refused to issue permission for Thomas to get the treatment his parents' wanted for him.

At this point, the family was near the end of their emotional and financial resources. They contacted U.S. Rep. Dan Burton (R-IN) who researched their story and decided to take up their cause. He introduced the Thomas Navarro Patient Rights Act in Congress, a bill which would guarantee Americans freedom of choice in their medical treatments. A filibuster ended the bill before it passed, but Rep. Burton plans to reintroduce it this year.

Finally, the Navarros appealed to Rep. Burton for help in making the FDA adhere to its promised to them. They are not quite sure what he did or who he called, but suddenly, miraculously, permission was granted. Two months ago, Donna flew to Houston with her two sons so Thomas could begin his treatment.

The latest MRI shows signs of tissue death in all but three of the many tumors clustered in Thomas's brain and along his spinal column. The three unaffected tumors are the smallest and newest, so the Navarros feel confident that the antineoplastons will begin to shrink those tumors also.

The family is happy to be out of hiding, but they are still fighting medical discrimination. Thomas is currently in Texas Children's Hospital because an imbalance in the electrolytes in his blood sent him into a seizure last Wednesday. The doctors there seem unhappy with the course the family has taken, but as Jim says, "We will do anything we believe is necessary to help our son win his battle against cancer."

The biggest battle the family has now is financial. They have depleted all their resources and are basically living on occasional donations from friends and family. Al and Judy Allen, a Houston couple who have helped the families of many cancer patients, have set up a fund for the Navarros at Wells Fargo bank. If you would like to help the family with a donation, the account number is 6472924544. Make your check payable to either Jim or Donna Navarro.

If you would like to learn more about the Navarros' fight to get antineoplaston treatment for their son, visit www.cancerbusters.com .