My Experience with Ampligen, 1997-1998Wednesday, April 29, 1998
I am one of the 20 American CFIDS (Chronic Fatigue and Immune Dysfunction Syndrome) patients currently enrolled in the US Food and Drug Administration (FDA) - approved Ampligen 511 cost recovery study. Now in my fifth month of treatment, I am one of five patients receiving Ampligen at the Incline Village, Nevada, site. Our investigator (research jargon for the physician who is conducting the study at our site) is Daniel L Peterson, MD.
Ampligen is working for me-well enough, in fact, that six weeks ago, for the first time in YEARS, when my son asked me to go downhill skiing for an hour or so with him, I went. I fell on an icy spot and broke a rib, but I would not trade a minute of that day for anything. For a short time I was liberated from CFIDS, IVs, chronic illness, Ampligen and the world of experimental drug therapy. The freedom and exhiliration I experienced that day are memories I will cherish forever.
They were the first moments of my return to an active lifestyle, if only for a brief period of time, a lifestyle I hadn't been able to enjoy for many years. I had the opportunity to spend some quality time with my son, to be outside doing something active, and to enjoy spectacular views of Lake Tahoe and the Nevada desert. I kept thinking, "I don't believe this! Here I am on skis, acting like I'm normal! This is amazing!" The broken rib will heal. I'll keep the memory of that day forever. I've been called "Her-mann," for the skier who crashed during the Olympics this year, and "the Alpine Ampligen Skier."
They are names I'm pleased to be able to be called!
Over the past few months, my thinking has gotten sharper and clearer. I can concentrate for longer perods of time. My reading has improved (I was a prolific reader once, but lost that skill when I got CFIDS). This year I was able to organize my financial information for taxes (mostly by myself!), after being on Ampligen for only a couple of months. For years I was too cognitively impaired to even attempt this challenge.
My laboratory tests are improving. For example, my white blood count, which since CFIDS has been abnormally low, is now in the normal range. My Natural Killer cell function, part of the immune system's defense against cancer, is in the normal range for the first time since I began having it checked seven years ago. These are objective, biological measurements of improvement with Ampligen. They go beyond whether or not I can balance my checkbook better now than I could two months ago, or do a load of laundry without assistance.
I first knew for certain that I was responding positively to Ampligen about a month into treatment. My husband and I were sitting at the kitchen table working out the logistics of getting our youngest son, Calen, who also has CFIDS, through the last semester of his senior year in high school, to graduation in June. I was prioritizing what needed to be done, and in what order, on paper. My husband put his hand gently on my arm as I was writing. I looked up at him and said, "What!?" He smiled and said, "You're coming back to me, my wife is coming back!" I knew then that Ampligen was working for me. I could see it in my husband's face.
I have not always been sick and disabled. My life was full and rewarding before I came down with what I thought was the flu in February of 1989. I was a successful competitive distance swimmer and soccer player, a farmer's wife, and the mother of 3 active and busy children. I kept the books for our business. When I got sick that February, I was acutely ill for weeks, with spiking fevers. Whatever I had went into my chest, and I developed pneumonia.
The doctor told me to expect a prolonged recovery, since I had been so ill. Six months later, however, I was still not able to swim or play soccer, or do the books, or keep up with my responsibilities as a wife, mother and business partner. I was struggling just to make it from morning to night. Twelve months later, I was sicker. Eighteen months later, the same. Finally, after going to several different doctors, trying unsuccessfully to find out what was wrong, I saw Dr Peterson in 1991. He ruled out other possibilities, and diagnosed me with CFIDS that October.
1991 was also the first year I heard about Ampligen. The FDA-approved Phase II double-blind, placebo-controlled trial was still underway, and there was a lot of excitement and anticipation about what seemed to be sure-fire FDA approval of the drug within months. But the excitement fizzled out and the anticipation dissolved over the next six years into disappointment and disgust. Such a promising drug, yet so many problems, and so much hope and potential wasted! My interest in Ampligen waxed and waned as rumors about new studies came and went.
In the spring of 1997, I read in a press release that the FDA had actually approved a new study with Ampligen. It was called the Ampligen 511 open label, cost recovery study.
"Wow!" I thought. "This time it might really happen!" My curiosity and interest were tweaked once more.
Dr Peterson and I talked about the eligibility requirements for the study. I was a candidate. I was within the age range, I met the 1988 CDC case definition, I was significantly disabled by CFIDS, and I had the low molecular weight enzyme (37 kilodalton protein), in the RNase L part of the 2 5A Synthetase/RNase L antiviral pathway. This novel enzyme was first identified by, and is currently being studied by, Dr Robert J Suhadolnik and his research team at Temple University.
The Ampligen 511 study is a cost recovery study, which means that the patient must pay for the drug and the cost of administering it. My husband and I sat down with paper and pen, and considered the cost of participating in the study for six months ($6900 for the drug, another $5000-7000 for infusions, tests and related medical expenses). We compared this amount with how much we had lost in income during the nine years I have been sick. Over the years, an enormous amount of my husband's time and energy has been diverted away from farming to caring for me. We factored in what we would continue to lose in income in the future if I remained at the same level of illness and disability. We also factored in the loss of our entire family's quality of life over the years, and the sacrifices everyone had made. Our children had assumed some of my responsibilities, and my husband had added the rest to his already full work load. I had lost irreplaceable time with my children while they were growing up, and precious quality time with my husband. Finally, we factored in the inconvenience of my having to relocate from Northern California to Nevada to participate in the study, leaving my family behind.
We weighed the possible benefit of taking Ampligen (enough improvement to be productive again in the family and business) against the possible risk (it might not work for me). Safety was not an issue. Hundreds of CFIDS patients in previous studies in the US and Europe had taken Ampligen with no serious side effects.
Would Ampligen work for me? I'd never know unless I tried it. As we weighed the pros and cons, I realized that I couldn't let the chance to try for better health pass me by. We decided to borrow against the cash value of our life insurance policies, as we have done in the past for big expenses such as college tuitions for our children, if I were chosen to be in the study.
I told Dr Peterson I would like to be considered for selection to the Ampligen 511 study.
Then I waited to hear the outcome of the selection process. Not surprisingly, there were delays, but in November I learned that I had been chosen as a study participant. Baseline testing and a ton of paperwork followed, and on December 15, 1997, my four fellow Ampligen 511 study patients and I received our first doses of Ampligen in Incline Village.
We were all excited and more than just a little scared that first day. As the drug dripped into our veins for the first time, I think most (if not all!) of us were cautiously watching one another as well as ourselves to see what kinds of responses might occur. I know I was.
Intellectually, we know that we are all different, our symptoms are not identical, and we all respond in different ways, but human curiosity is strong enough to keep us wondering how we are doing in relation to the others. We've become a closely knit group over the months, supportive and protective of one another as we move through the study. We've been at it long enough now to know that we are progressing at our own individual speeds, but we still compare notes!
The study isn't over yet. I do not know what the future holds. Hopefully we will receive permission from the FDA to extend beyond the six months of the original study. I still have a lot of healing to do, but I know without a doubt that I am on my way, thanks to Ampligen. I wonder a lot about the future. Will we have to stay on the drug indefinitely in order to continue to enjoy its benefits? Or will we reach a point where we go from two infusions a week to one, and eventually to some kind of maintenance dose? As study subjects, we're still in the trenches with this experimental drug, and the answers to these questions aren't available yet.
Anyone who is considering taking Ampligen needs to realize that the healing process is not quick or even consistent. It is an up and down thing, like being on a roller coaster.
You may feel good one day, and wiped out the next. You need to be patient, and you need to remember to keep your eye on the big picture, and not get too caught up in how you feel from one day to the next. Don't expect recovery to happen overnight. It takes awhile for the body to adjust to the drug. Each patient is unique, each person's symptom picture and experience are unique. Each patient will progress at his or her own pace.
Changes and improvements are often subtle. Other people may notice them before you do. Or one day you may suddenly realize you're doing something mundane, like cooking soup from scratch, that you haven't been able to do for years, and you think, "I must be getting better! I couldn't have done this last year!"
Each of us measures quality of life according to our own life experiences and dreams.
For me, it is being able to do the things I used to take for granted, but haven't been able to do for a long time. It means being able to plan and cook a meal so that everything reaches the table at more or less the same time, and in more or less edible condition. It means being able to stay up to talk with my husband or children about something important that is going on in their lives, and really participate in the conversation. It means having the energy to visit with friends, to go out and be active again for a bit, and to be able to get out of bed the next day. It means being able to think about being productive again, even to think about going back to work part-time in the future. It means HAVING a future to think about.
The choice to take or not to take Ampligen is a personal one, but all CFIDS patients deserve the right to make that choice. Thanks to the letter writing efforts of hundreds, perhaps even thousands, of CFIDS patients, their families and their friends, Ampligen is closer now than it has ever been to being approved by the FDA to treat CFIDS in the US.
Approval means reimbursement of costs by insurance companies, accessibility to the drug, and the creation of opportunity for the development and approval of other promising drug treatments for CFIDS. I look forward to the day when every CFIDS patient in America has access to this drug, and to the other drug treatments that will inevitable follow.
This piece first appeared in CFSMail, edited by Linda Clement