Government Reform and Oversight Committee
February 4, 1998

Ms. Becky Nippert

My name is Becky Nippert. I am forty-four years old and live in Memphis (Germantown), Tennessee. In '75 I became a registered nurse, and in '82 I became a nurse anesthetist. In '89 when I was 35 years old, I was diagnosed with breast cancer. At this time I was married with three small children, age: 5, 3 and 5 months. I had a mastectomy, placement of a Hickman catheter to do six months of intense chemotherapy and two breast reconstructive surgeries that year. I was very sick from treatment and lost my hair. In '93 the cancer returned in the same area. The surgery I had removed much of the chest muscle to prepare me for the 37 radiation treatments I received while working full-time and raising my three children as a single parent. My marriage ended in divorce four months before the recurrence. While I took radiation, I was put on the drug Tamoxifen, which was short-lived because of the severe side effects. Six months after finishing radiation, I had another reconstructive surgery.

Seven weeks later, in August '94, I went for my cancer checkup and reported to my doctor rib pain, genial loss of a sense of well-being and fatigue. He checked the tumor marker Ca 15-3, which is a blood test that, when elevated, indicates cancer activity in the blood. Normal is 3 to 27. My previous results had never been elevated. The test result was 49. An enlarged lymph node had come up in my neck and my doctor ordered a bone scan which showed tumor invasion in my sternum and two ribs. I got a rib biopsy on the rib which was fractured by cancer activity and it confirmed metastatic breast cancer to the bones. He recommended the only thing left, the stem cell rescue or bone-marrow transplant. I had heard of some success with this for Iymphomas or leukemias, but in all the patients I talked to with breast cancer who had this therapy, none had a good result from it.

All reported recurrences rather quickly after that or their families reported they had passed. This is an accepted treatment covered by insurance. A second opinion was to get my ovaries out, get my affairs in order and get the bone-marrow transplant. My original tumor was estrogen receptor positive, which means tumor growth is aggravated and enhanced by the presence of estrogen. I had ovary surgery, thereby cutting out most of the estrogen production in my body. I did get my affairs in order and this relieved me of some stress. While I was thinking about the bone-marrow transplant and weighing what to do, I started the first three standard chemo treatments to prepare me for it. The hospital where I went put me on the bone-marrow transplant unit. The person in the room next to me was on kidney dialysis for shutdown of her kidneys secondary to the bone-marrow transplant. The patient in the next room was sent to the intensive care unit for septre shock. The 32-year old female patient next to her was rocking back and forth on her bed babbling to herself. When I asked what was wrong with her, I was told she had been isolated 52 days and was in an isolation psychosis, but she would probably eventually be all right. After this chemo, my tumor markers went up to 59, and in the seven weeks since my bone recurrence, my tumor load had increased from 3 to 13 bone tumors. My bill for one week in the hospital for chemotherapy was $33,000.00. At this point I heard about an experimental treatment that had positive results from trials in Monterrey, Mexico. Trials had also started in Freeport, Bahamas. Since the oncology experts had given me a less than one percent for survival, and I didn't see how the bone-marrow transplant could help, but only harm me further, I decided to try the treatment. I went to Freeport and got on this therapy, which was to be given by IV three times a week after I go back home.

After being on the therapy two weeks, my tumor markers went down to 49 and in the next few months they went to 41 to 29 to 21 and then down in the teens and to this day have not been elevated. My tumors started to disappear on the bone scans. I aborted the pursuit of the bone-marrow transplant. My quality of life was good and most of my bone pain subsided. In September '95, when I was trying to order new treatment from the company, I was told after repeated attempts to reach them that the company had been raided by the F.D.A. and there would be no more distribution of this treatment in this country again. No explanations were given. I had been cut off from the therapy that was making me well. I wrote President Clinton and received a form letter from the White House. I wrote the Commissioner of the F.D.A., David Kessler, several times and never personally heard from him, but got form letters from the F.D.A. The last one I received said that they were sorry that they could be of no further assistance to me. I wrote my Senators and Congressmen. To this day, two and a half years later, I still don't know what happened. I was able to get some extra treatment from a nearby hospital which ad used it prior to the F.D.A shutdown.

My local doctor didn't feel like he could treat me anymore. I asked the doctor in Freeport, Bahamas, to let me have some of the medicine. I knew there were about 2000 doses of the treatment in a freezer in that medical clinic down there. I told her I would keep quiet and would move myself and children down there. She said no. I found out that the F.D.A. had gone down to question her and investigate. This is the same agency I called and could never get an answer that they even knew anything about it. I was able to get a small supply and a freezer to keep in my home. Three times a week I struggled to get IVS started on myself to administer the medicine. Many nights it was a blood bath, sticking myself up to nine times. Thank God I was a nurse with the ability to do this. When the medicine was gone, I still had three bone tumors.

In February '96, I came to this building and appeared before a subcommittee at a hearing of the Commerce Committee to gain access to the treatment that had been shutdown. Four of us patients on this specific therapy testified and two other patients came to lend moral support. We pleaded to get our treatment back. We all were recovering and doing well on it. Nothing happened to help us and today three of those patients are dead and one on his death bed. Only two of us are still alive, and we were the ones that were able to stay on the medicine longer than the others. We were all given the death sentence by conventional medicine. We tried an unconventional new therapy. We were getting our lives back and doing well when the medicine was pulled with no explanation or help from anyone. This negligence killed them. In my field it is called malpractice.

There was no one we could find to help us as patients. I heard on the second panel that today there is a lawyer who represents patients to the F.D.N Why, in the run-around and phone tag with all these important people, were we not told about him? Is this something new or something that was not available two years ago? No one was there for us. One person on that committee said they wanted to do no harm. Let me tell you what goes on down in the trenches. I am a cancer veteran. I have been there and done that. My friend, Rosemary, got some metastasis in her lung from breast cancer. She got the stem cell rescue at Christmas and died New Year's eve of liver failure, not from the cancer, but the treatment. She is dead at 42-years old. Merrilee Malcom, my friend from Atlanta, wanted alternative therapy and begged for it after being refractory to standard therapy. She died at age 32. She was written off and not helped after chemo. They told her she failed therapy. She did not fail chemo. Chemo failed her. Please wake up. Many more people have died from cancer than in the holocaust, and we are even having to debate this? We, as a country, have failed miserably in this area.

I have been a nurse and a nurse anesthetist my whole adult life. I tried everything conventional first. It didn't work and when I found something that did, my government cut it off with no provisions for the patients that were benefitting from it. Many patients that were doing well on this treatment have died. The only thing they were protected from was hope and life. Since then I have been on a treatment from Germany. I have been totally cancer free with clear scans since last summer. I am alive today because of prayer and alternative treatments. At this point give us the treatments we need. Remember we were written off and given the death sentence. Is this inhumane to do research on humans? I was glad to be a guinea pig. Speaking as a guinea pig and cancer patient, I say no. We have nothing to lose and maybe something to gain. We can advance medicine in the process.

We don't have a powerful lobby like the pharmaceutical companies. After we are diagnosed, cut on, treated with poison and then radiated, most of us are worn out. We have then become victims of the cancer industry and most can't speak for themselves anymore because they have been beaten down in every area. Conventional therapy has had total control from 50 to 100 years. We have more cancer and more people dying from cancer than ever before. We are not exploring the unknown or allowing people with different opinions a chance. We only go for mediocrity and maintaining the status quo. We are falling behind and are definitely not on the cutting edge. We put down anyone with an individual idea or something new and original. We stay in our comfort zones at the expense of people's lives. We don't branch out into areas we don't fully understand. How can we when the requirement to approved treatment is $240,000,000 and ten years of trials, the last of which is on humans.

Overseas where the medical giants are, they are allowed to use different procedures without these almost totally impossible requirements. Many people here are too weak to travel to other countries or can't afford it. I, and many others, would like therapies with decreased side effects. Give us the choice. Medicine can be advanced so that we can find out what works well on different types of cancer. Why not give us our treatment of choice? Remember we are talking mainly of people here who are at the end-stage. What do we and what do you have to lose? The patients, more than anyone else, know they may die. They have already been written oś Open up to more than one bias and give other types of therapies a chance. It has to come from you. The doctors just can't start doing it unless it is approved by you.

I have a friend in Seattle, Washington, who is a radiation oncologist, and lost his medical license for using alternative therapies in his practice. He gave his patients choices and they did well. When he wanted to appeal to the Supreme Court, he was told he couldn't do that because it was against the ruling of the American Medical Association, the American Cancer Society and the National Health Institute. They are basically immune and have no accountability. This is where it ended. The heads of these and the H.M.O.s, who now control medicine, make seven-figure salaries. They will keep giving grants in the same areas, and we aren't doing anything but advancing. Please open your eyes. I am alive today in spite of being abandoned and restricted by the government while others have not been so fortunate. I was on my own fighting to stay alive with no help at all from this free United

States, only obstacles. This is the ultimate injustice.

Please spare me the cliche "that you don't want the patients to be harmed. " I am today cancer-free, and have been working full-time doing anesthesia again for over a year after having been on disability for 22 months. I believe God spared me to speak for those who can't speak for themselves. By my story, you can see the near impossibility to get anything other than conventional therapy. Please don't turn your back to the problem and neglect so great a need. Don't wait until it happens to your wife, husband or child, or your prostate or breast. Don't wait until your back is against the wall or your neck on the line. I plead with you: Help patients get other therapies that may save their lives.