-------- Original Message --------
From: Patricia Walter
To: Catholic Truth Pub; Catholic Press Directory; Catholic Online; Catholic Herald; Catholic Dossier; Catholic Digest; Catholic Connect; Business Week; Burlington Free Press; Brave New Waves; Boston Herald; Boston Hearld; Boston Globe, Story Ideas; Birmingham News; BBC East; Bangor Daily News; Atlanta J and Constit; Assignment Desk; As It Happens; Arnold Gore; Arizona Republic; Arizona Daily Star; Anapolis Capital Gazette; America's Voice TV, Paul Lyons; America's Voice TV, James S. DuBreuil; America's Voice TV; American Press Service and Features Syndicate Israel Bick; America Magazine; Alburquerque Journal; ABC News, Lisa Stark; 60 Minutes; 48 Hours, Richard Schlesinger; 48 Hours, Erin Moriarty; 20/20, Bob Brown; 20/20
Sent: Wednesday, May 31, 2000 1:14 AMS
Subject: 4-year-old boy fights the FDA on June 7th

WHO DECIDES? THE PARENTS OR THE FDA? Father of 4-Year-Old Brain Tumor Patient to Square Off Against FDA Head of Oncology

WHEN & WHERE: June 7th and 8th, 1:00 PM, Rayburn Building, Room 2154

WHAT: HOUSE COMMITTEE ON GOVERNMENT REFORM AND OVERSIGHT

Washington, DC -- One of the purposes of this hearing is to investigate the FDA's use of its authority to force cancer patients and parents of cancer patients to accept treatments they do not want, or else face legal action. The hearings were prompted, in part, by the recent case of Thomas Navarro, a 4-year-old boy with a brain cancer known as medulloblastoma. Thomas's story has recently been featured in People Magazine, on “CNN and Time,” Tom Brokaw's NBC news, and the CBN “700 Club.” Thomas's father Jim will appear on the Fox News Channel with Paula Zahn at 10 PM on June 8 (the day after Jim testifies) along with Rep. Dan Burton.

Jim and Donna Navarro refused conventional therapies for Thomas after reviewing the most recent medical literature published by some of the most prestigious cancer centers in the country. The Navarros’ research revealed that the FDA-mandated treatments for the disease, combination chemotherapy and full craniospinal irradiation, produces consequences unacceptable to the them—hearing and vision loss, hyperthyroidism, severe mental retardation, loss of cognizant speech, stunted growth, radiation-induced psychosis and rage disorder, secondary cancers, and in many cases, death.

Based on these medical studies, the Navarros made a fully informed decision to turn down chemotherapy and irradiation for their son, and to seek other therapies. Specifically, they wanted to have Thomas treated by Stanislaw R. Burzynski, MD, PhD, in Houston, Texas. His antineoplaston therapy has shown excellent results against medulloblastoma, with few side effects. Since making this decision, the family has been stonewalled by the FDA and hounded by Child Protective Services whose aim was to seize Thomas, subject him to these draconian, ineffective treatments against the wishes of his parents, and to imprison his parents for their temerity in opposing the dictates of the FDA.

At the hearing on June 7, Jim Navarro and other parents whose children have been harmed or killed by chemotherapy and irradiation will ask: Why don't parents have the freedom to choose the treatment they want for their child? Why is the FDA forcing the Navarros (and other families throughout the country) to submit to cancer treatments that have been proved to be ineffective and harmful (in the case of chemotherapy) or, do irreparable damage (full craniospinal irradiation)? Why does the FDA insist on the continued use of these harmful therapies and continue to deny families the right to seek other, potentially beneficial treatments?

FDA Commissioner Henney and Health & Human Services Secretary Shalala have ignored the pleas on behalf of Thomas of many powerful people, includingAlan Keyes, George W. Bush, Senators Orin Hatch and Tom Harkin, and Rep. Dan Burton. Henney and Shalala also have ignored tens of thousands of phone calls and letters, maintaining their indefensible position in this matter.

During the hearing Jim Navarro will square off against Dr. Richard Padzur, the FDA's head of Oncology, and one of the people responsible for denying Thomas access to the treatment his parents have chosen for him. There will likely be heated debate between Navarro and Pazdur, focusing on issues such as the following: medical freedom, a parent's right to choose a medical treatment for his child vs. the FDA's usurping that right, and the way the FDA manipulates statistics to present positive outcomes for treatments which are, in reality, dismal failures.

Amazingly, neither of the two mandated treatments, chemotherapy and irradiation, have ever actually been approved by the FDA for pediatric use. Yet, they have become the "standard of care" despite the fact that much evidence exists to prove they do not work, can kill the child, and certainly cause irreparable harm. Multiple studies going as far back as the 1970s reveal the failure of these treatments, yet the FDA and the pediatric oncology community continue to mandate these known failures as “standard treatments,” and no one questions their authority to do so. Child Protective Services is often used by the medical community to strong-arm the parents into compliance.

Who should decide if it is preferable for a child to possibly live a few years with no quality of life and intense suffering, or perhaps have a shorter life with quality? Who should make the choice to decide to try something that may cure their disease or extend life without the great damage done by conventional therapies?

James Navarro is working for passage of H.R. 3677, The Thomas Navarro FDA Patient Rights Act. This act would bar the FDA from placing clinical holds on investigational treatments such as antineoplastons just because the FDA believes another therapy is preferable. With the patient's or the parents' declaration in writing that they are fully aware of the conventional treatments and are willing to accept the risk associated with taking an investigational drug, the FDA would have no control of what the patient or the parents would choose.

For more information about the hearing, contact Beth Clay, Chief Counsel, at 202-225-5074.

To Contact Jim Navarro and the Cancerbusters Foundation: please call or e-mail Rita Starr 305-532-3113, e-mail: ritarow@aol.com, or Pat Walter: pwalter@nni.com

For more information on Thomas Navarro and this case, please visit: www.cancerbusters.com

Support the Thomas Navarro FDA Patient Rights Act, HR3677, which will provide expanded access to new treatments for all Americans, especially patients with cancer. Contact your Congressmen and see Thomas's story: www.cancerbusters.com.