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Government Reform and Oversight Committee

February 4, 1998

Ms. Mary Jo Siegel

Seven years ago, I was stricken with a fatal cancer, non-Hodgkins lymphoma, for which no conventional cure yet exists. This disease is treatable for periods of time with chemotherapy and/or radiation, but the outcome is always death.

My husband Steve and I were devastated by my prognosis, but determined to find a cure. Our research took us to top Iymphoma specialists at esteemed medical institutions like UCLA, USC, Stanford and the Dana Farber Cancer Institute in Boston. All the experts confirmed our worst fear. With existing therapies, my disease was incurable.

At Dana Farber, a ray of hope emerged with the recommendation that I undergo an autologous bone marrow transplant. This highly controversial procedure would require that I receive extremely high-dose chemotherapy and as much radiation as people who were within one mile of "ground zero" at Hiroshima. I would lose my hair, experience severe nausea and vomiting, and the threat of bacterial and viral infection would keep me in complete isolation for 6 weeks. My quality of life, post treatment, would be drastically diminished. From the chemotherapy I would become sterile. There would be damage to my heart, lungs, liver, kidneys, and bladder. Collateral radiation damage would affect my eyes, salivary glands and thyroid, with a greater than 50% chance that I would develop leukemia if I were lucky enough to survive just 10 years. I was frightened and suspicious because only a handful of patients had survived this procedure with good long-term results. One such person was the late Senator Paul Tsongas, who eventually died of complications caused by the procedure.

Fortunately, we discovered the work of Stanislaw Burzynski MD, Ph.D., who was treating advanced cancer patients with a gentle, non-toxic therapy he had discovered. As I began Dr. Burzyuski's antineoplaston treatment, my lymphoma had progressed to stage 4 (there is no stage 5). Malignant tumors were growing throughout my body. My bone marrow was infiltrated and there was a large and growing tumor on the side of my neck. After only 3 weeks on this medicine, that tumor disappeared! Subsequent scans performed at UCLA showed continual reduction in tumor size.

During antineoplaston treatment, my quality of life was excellent, virtually free of side effects. I was an active and involved mother, an absolute necessity when you are raising 3 teenagers. More importantly, the drug stopped my supposedly terminal cancer. Within 12 months I was pronounced in remission, not by Dr. Burzyuski, but by the same lymphoma expert at UCLA who had originally diagnosed me and told me I faced certain death from this disease.

I went off treatment and remained in remission for 2 years, when a follow-up scan revealed a possible return of the disease. Immediately, Dr. Burzyoski prescribed a regimen of antineoplaston capsules. Within 5 months I was once again in remission, and have remained cancer free to this day.

That's the end of the good news. The tragedy is that our government, namely the FDA, has been keeping what author Tom Elias calls "the century's most promising cancer treatment" from becoming widely available to cancer patients. The agency has spent untold millions of taxpayer dollars in a systematic attempt to harass, discredit, stonewall and even imprison Dr. Burzynski.

As incredible as it sounds, in November 1995, FDA indicted Dr. Burzyuski on 75 criminal counts, most having to do with alleged technical violations of the Interstate Commerce Act and none having to do with his practice of medicine or the effectiveness of his drug. Dr. Burzyoski had been legally treating patients under Texas State law for some 20 years and not one patient in all that time had ever filed a complaint. If Dr. Burzyuski had been convicted on all 75 counts, he could have been sentenced to 290 years in a federal prison.

Are antineoplastons effective? Ask the FDA. Apparently it believed the answer is yes, because it fought tenaciously to keep the question of antineoplastons' effectiveness out of the trial. Dr. Burzynski tried to make it a part of the trial. Apparently, both the FDA and Dr. Burzynski believed he could prove the drug works. FDA also fought to keep the full truth from the jury by preventing Dr. Burzynski's patients from testifying, while Burzynski asked the judge to allow the patients to tell their stories.

In the end, Dr. Burzynski was acquitted on all counts. But I ask you in Congress, and particularly my representative, Mr. Waxman, how you can allow the FDA to squander taxpayer money in an idiotic prosecution, the success of which would mean the deaths of hundreds of cancer patients? FDA was unable to find even a single patient to testify against Dr. Burzyuski!

Peter Barton Hutt, a former FDA Chief Counsel, has said "if you beat the FDA in court, you have an angry FDA that is willing to slit your throat". Indeed, while it lost the courtroom battle against Dr. Burzynski, it continues to wage war against him and his patients. The agency interferes in his practice by telling him whom he can and cannot treat. With many types of cancer, the FDA requires patients to have failed not one, but two rounds of chemotherapy before they can be treated with antineoplastons. In many cases the chemo has so ravaged their immune systems, they literally have nothing left to fight with and they die.

FDA forbids the use of steroids in the treatment of Dr. Burzynski's lymphoma patients, even when they are needed to temporarily shrink tumors and relieve pain, as in my own case. Because I was on treatment prior to the FDA taking over his practice of medicine, Dr. Burzynski was able to inject me with "Medrol" to relieve pain and tightness in my neck caused by the tumor. Now, however, the FDA is not concerned with patient comfort. Their twisted logic dictates that good data collection outweighs humane medical treatment.

The FDA demands that Dr. Burzynski's lymphoma patients stop treatment if they have not achieved 50% tumor reduction within 6 months. The absurdity of this typically arbitrary FDA requirement became clear when one Burzynski patient Frances Langham was to be forced off treatment when she achieved a 44% reduction after 6 months! She is lucky to be from Arkansas and politically connected. She received a "special dispensation" allowing her to continue treatment. But the FDA removed her from the clinical trial, meaning that even if cured in the future, FDA will count her as a "treatment failure" in detesting effective Antineoplastons are! These treatment "restrictions" are only applied to Dr. Burzynski's clinical trials, whereas lymphoma patients involved in Idec Pharmaceutical's C2B8 and Elan Pharmaceutical's phenylacetate trials do not have to meet these same treatment criteria. Is it possible that FDA has a bias against Dr. Burzyuski and his patients have to suffer as a result?

Who gave the FDA the right to plop God? Was it the intent of Congress to give FDA the kind of power it exercises over life and death with no accountability? By denying terminally ill cancer patients access to antineoplastons, this agency literally decides "who shall live and who shall die".

I have had to watch as children and adults suffer and die as a result of FDA intransigence. Patients plead to be allowed into antineoplaston clinical trials, but FDA says "no you don't qualify." Shouldn't it be the doctor, in concert with the patient, making these important medical treatment decisions, rather than an FDA official who doesn't even know the case? Clearly the FDA is denying these patients their freedom of medical choice. Because conventional, FDA approved remedies have failed to work for the majority of Dr. Burzynski's patients, often their only choice is antineoplastons or death!

It's been 26 years since President Nixon declared the "War on Cancer." Public expenditures now exceed 30 billion dollars and private research and development funds must total at least 10 times that amount, yet the death rate continues its relentless climb. It's time for a new approach to treating cancer. The only way this will become reality is by allowing cancer patients expanded access to new, experimental and innovative treatments. Until we have a cure, all of it, conventional and alternative is experimental!

Dr. Nicholas Patronas, chief of Neuro-Radiology at NCI, testified under oath that antineoplastons are the most effective treatment for brain tumors he has ever seen. Top oncologists have lauded Dr. Burzyuski's work, including those at the University of Washington and Georgetown University. Doctors and scientists around the world eagerly await the approval of antineoplastons. Dr. Michael Friedman, the current commissioner of the FDA once wrote that "Antineoplastons deserve a closer look...the human brain tumor responses are real." So why is FDA so determined to impede the progress of a drug with such promising results? 5

Congressmen, we implore you to restore the right to choose our own health care. You have the power to give us back our freedom. Mr. Waxman, as your constituent I know you staunchly support both the FDA and a woman's right to an abortion. But can you really condone a government which grants a mother the right to choose death for her fetus, while deriding a dying cancer patient one last hope for life?

In his March 29, 1996 press conference, President Clinton announced new initiatives to expedite the approval process for innovative new cancer drugs like antineoplastons. Since then FDA has bluntly stated that the President's initiative has changed nothing. It's time for congressional oversight to insure that mandate is carried out. The terminally ill deserve the chance to win their personal war on cancer and it's up to Congress to insure they have the weaponry with which to fight. Thank you.

Article on 2/4 Hearings

2/4/98 Testimony

2/12/98 Testimony

Moss's Editorial on Hearings

Ralph W. Moss, Ph.D. is director of the The Moss Reports for cancer patients. Dr. Moss is the author of eleven books and three documentaries on cancer-related topics. He is or has been an advisor on alternative cancer treatments to the National Institutes of Health, the National Cancer Institute, the American Urological Association, Columbia University, the University of Texas, the Susan G. Komen Foundation and the German Society of Oncology. He wrote the first article on alternative medicine for the Encyclopedia Britannica yearbook. He is listed in Marquis Who's Who in America, Who's Who in the World, Who's Who in the East, and Who's Who in Entertainment (as a film documentarian). This Web site does not advocate any particular treatment for cancer. We urge you to always seek competent medical advice for all health problems, especially cancer. Before consulting our site please read our full Disclaimer statement.

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