Saturday, March 23, 2013

Ampligen and biomarkers: my testimony to FDA Dec 2012

To: The Advisory Committee Reviewing Ampligen
      FDA, Washington, DC
From: Mary M. Schweitzer, Ph.D.
Date: December 5, 2012
Subject: My experiences with ME/CFS and 14 years on Ampligen

My name is Mary M. Schweitzer. I was a 44-year-old tenured professor of history at Villanova University when I suffered a blackout in my office on October 24, 1994. When I came to, at first I could not move at all. Once I could move, I was unable to understand a word in the papers on my lap that I had been grading. From that point on I was very sick, and my condition would continue to worsen for the next four years. I had no difficulty getting approved for private long-term disability and Social Security Disability Insurance because no one doubted how sick I was. I suffered from blackouts, ataxia, absence seizures, expressive dysphasia, disorientation, short-term memory loss, dyslexia, tinnitus, sensitivity to light and sound, and massive confusion to the extent that once I poured an entire pot of coffee into a silverware drawer, convinced it was a cup. I could not even pass a simple Romberg Test (I fell over as soon as I closed my eyes). I had intense pain behind my eyes and in the back of my neck 24/7, suffered intense headaches, and had constant muscle pain. Some times the pain was so bad all I could do was lie in a darkened room listening to a favorite movie.

My world grew smaller and smaller. I could not drive a car, but I could go places. In the summer of 1996 I started falling when we tried to walk to Camden Yards in Baltimore from the parking lot, and we had to start using a wheelchair whenever I left the house. I had a perfect score on my grad records in 1975, but now I could not understand a comic strip if I tried to read it in print. I found I could write on internet, although I had trouble reading much. In 1997 we added a riser to the toilet and a shower chair. I wrote several short essays and posted them; they all have a copyright date of 1997 because by 1998 even that was too difficult. Finally, in the fall of 1998 I was completely confined to bed, able only to make it on my own to the bathroom and back by holding on to furniture and walls and my golden retriever. By the end of 1998, I could not even brush my own teeth.

I had a good physician in Washington, DC (Marsha Wallace, who has since retired). I was diagnosed with NMH/POTS in 1995 and began taking florinef, and I developed Hashimoto’s thyroiditis in 1996 and began thyroid supplements. She introduced me to Dr. Dharam Ablashi, the co-discoverer of HHV-6 and its two variants. He found me positive for HHV-6, Variant A, in the fall of 1998; he told us that my lymphocytes were riddled with the virus. [Variant A was the strain of HHV-6 he had found in AIDS patients.] He also sent a PBMC pellet from my blood to Redlabs in Belgium, where they found me positive for the 37kDA Rnase-L defect. We now had two serious biomarkers.

I knew that Dr. Dan Peterson of Incline Village, NV, had found that patients with the 37kDa Rnase-L defect were more likely to respond to the experimental drug Ampligen, and I also knew that Drs. Ablashi and Paul Levine had run experiments with Ampligen and HHV-6A in vitro and found that Ampligen kept the virus from replicating. With those two biomarkers, I thought I stood a good chance of benefitting from the drug, so my family agreed to try it for one year. It would be a great strain to our finances but it would be worth it if it could stop the downward spiral I was in.
I began Ampligen with the late Dr. Joseph Bellesorte in Chadds Ford, PA, on February 4, 1999. In two months I could walk without a cane. In five months I could drive again. But I think the most remarkable moment was when I realized that for the first time in four and a half years, I didn’t FEEL SICK. We retested me for HHV-6A and the 37kDa Rnase-L defect at six months, and both biomarkers were gone. Six months into treatment I read an entire book. In September I was able to dance with my son at his wedding, and I walked barefoot on a beach for the first time in five years. I continued to improve on Ampligen.

After 20 months on Ampligen, we thought I had been cured and we ended treatment while I began negotiations to start teaching again. That was not to be, however. One year after I stopped taking Ampligen, on October 6, 2001, I had a blackout at Cal Ripken’s last baseball game and had to be taken out in a wheelchair. Dr. Ablashi tested me and HHV-6A was back.
It took seven months to get back on Ampligen, but since I had experienced no adverse side effects, my family and I agreed that I should stay on it indefinitely. Now I received it at the I. Brodsky hematology-oncology practice at Hahnemann Hospital in Philadelphia. The cost had come down in half because the drug no longer needed to be prepared by a pharmacist before each use, and with co-pays, the entire cost (roughly $22,000/year) was covered by my after-tax disability pay. We lived on my husband’s salary as a chaired professor of finance at the University of Delaware.

I remained on Ampligen this time for over five years. My health improved more slowly, but eventually substantially. I was able to publish 2 history essays and I wrote a 650-page draft for a book manuscript on this disease; my husband and I crossed the country five times by car because our daughter was now at USC; in the summer of 2007 I could even take short hikes with my brother in California.

However, in January 2008, Dr. Brodsky died, and although he was not my doctor at the practice, permission to continue receiving Ampligen there was denied. They reapplied twice and were denied twice. Now there was no place on the East Coast where I could get Ampligen. You have to have it twice a week by IV – you cannot travel far to get it. We guessed that a two-hour radius from our home in Delaware was reasonable – and covered most of the mid-Atlantic, one of the most populous areas in the nation. There was no Ampligen available.

I thought I would have a year or longer, but I only had seven months before the crash came in September, 2008. Thanks to Southwest Airlines, I was already seeing Dr. Peterson in Nevada once a year for my specialist, and I was scheduled to see him September 23. By the time I got there, I was running a fever and had active cases of Epstein-Barr (EBV) and cytomegalovirus (CMV). My natural killer cell function was 3%. I had an abnormal SPECT scan, Halter Monitor Test, and cytokine pattern, and my VO2 MAX score was so low that it fit social security’s definition for permanent disability.

We tried Vistide, which Dr. Peterson had experienced success with in patients who had both HHV-6 and CMV, but after three doses my liver rejected it. He halved the dose, then halved it again, and both times my liver markers immediately spiked. I could not take Vistide. [During the period I was on Vistide, we asked a local (Delaware) infectious disease practice to give me the infusions every other week. They agreed, but when I came for my infusion, stopped me. “You have CFS, dear,” the doctor said. Uh, yes, but I have a recognized disease, CMV, and Vistide is an approved treatment for CMV (Cytomegalovirus, or HHV-5). “Vistide is too strong a drug for you because all you have is CFS. If you had AIDS or cancer, we could see giving it to you. But you aren’t sick enough to warrant taking such a strong drug.” I had to fly overnight to Reno to get that dose!]

My condition continued to deteriorate. In July 2009 Dr. Peterson had me get a spinal tap in Reno; my daughter came up from L.A. to take care of me, because by this point I was no longer capable of taking care of myself. The spinal tap showed that in my spinal fluid, I had active HHV-6 and CMV as well as the 37kDa Rnase-L defect. After consulting with my husband, Dr. Peterson concluded that I had to get back on Ampligen, which would mean moving to Nevada. However, my ataxia was so great that I fell in a motel room and suffered a slipped disk; we had to have that fixed before he would start the Ampligen, so there were more delays and I got still worse.

I moved out to Incline Village in March, 2010, and began Ampligen treatment again. My daughter and her boyfriend stayed with me the first two months to help take care of me. After they left, I leaned on the kind services of other clinic patients and their families, two generous taxi drivers who would get me fresh groceries, and my brother, who would drive from Santa Rosa once a month and make sure I had enough paper products, water, detergent, etc., for the next month. It helped that the apartment was only one floor.

Once again I no longer needed my cane after two months. I began to recover, but it was slower than before. However, by the summer I was walking along the lake (starting at 6 minutes a day, then adding 2 minutes a day each week), and in August my husband shipped my car out to me because I was well enough to drive again. I began working on the book manuscript again. I was doing well, but

I missed my husband of 35 years – 3,000 miles east. I wanted to go home, but I knew I could not go off Ampligen. Then, in the spring of 2011, I learned that Dr. Derek Enlander would be starting Ampligen treatment in New York City. I drove home from Nevada at the end of April, 2011.
It took longer to get back on Ampligen than we had thought, but I restarted it October 3, 2011, in New York City and have remained on it since. I have to commute the 100 miles north to New York twice a week, but I use local Philadelphia area and Amtrak trains, and there is a NY Metro bus that goes from Penn Station in Manhattan right to Dr. Enlander’s office, so although it is a long commute (3 hours one way), it’s not uncomfortable. And it has given me back a life.

As long as I can remain on Ampligen, I can take care of myself (although I have very little stamina). Our daughter has moved back in with us, because my husband has an aggressive form of bladder cancer and now he needs to be cared for. Without Ampligen, my family would have to take care of me as well – instead, I can be of help.

I have a great fear of losing Ampligen. It is difficult for a person who had been so successful in her life to be so dependent on a single drug, a single company, and a single decision by a government agency, but there I am.

Please do not take the drug away from me again.

Thank you.
Mary M. Schweitzer, Ph.D.
Newark, DE

Coda:  My husband died of bladder cancer at the age of 63 in July 2013.  In December, 2014, I moved back to Lake Tahoe at Incline Village, where I now live and continue to get Ampligen at Dr. Peterson's.  It is a good place to heal both body and soul.


















4 comments:

  1. Mary you were wonderful speaking and I have the utmost respect for you I wish you continued better health.
    Fondly,
    Gina Bettor
    A single

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  2. Mary, how is your health now? I have the same markers, but live in the UK where there's essentially no treatment for ME. I'd like to try ampligen so am interested to hear your story. I hope your health is still holding

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    Replies
    1. Thank you for asking. I have problems with physical strength, but my brain is totally clear. I do not feel sick. And you have to have had this disease to know what it means to say you actually do not feel sick - because I spent years feeling sick 24/7.

      Dr. Peterson is careful to test patients before he puts them on any treatment, and tries to match the treatment to what the tests (and symptoms) show. Those of us on Ampligen have very low natural killer cell functions (mine was 2-3%); the dysfunctional 37kDa Rnase-L (which you cant get tested for at the moment); abnormal cytokine patterns; and a number of active herpesviruses, particularly HHV-6A and CMV. Theoretically it should work against Coxsackie viruses, but we don't have as much information about that.

      The first 2-4 months are miserable because your immune system is revving up again. Everything hurts. I had to sleep all the time (that was just the way my own body responded). But, suddenly, it starts giving you presents - like the time I just walked out the front door without a cane (I had been mostly bedridden). Within six months you should know if it is helping, but if it is, you have to stay on it a while - 12-18 months. Most patients can go off it and their improvement lasts; I can't. I relapse - after 1 year the first time, 7 months the second time, and I think I was starting to relapse when I stopped Ampligen in 2014 to move from the East Coast out here to Tahoe.

      Ideally, your doctor should keep tabs on your biomarkers when you go off, and if, say, your natural killer cell function starts to tank again, or your cytokines, or viruses are popping back out - time to go back on it. We can't do that in the US because of the restrictions of the study- you're either on it or you're not.

      As for symptoms, my personal experience is that it helps those with serious brain fog best; can be a problem for patients with more pain issues than brain issues. More likely to help you if you are from the viral side than the chemical assault side. But that's my own opinion from all the patients I've known. My degree is in the wrong field.

      The biggest two problems with Ampligen are the cost and the fact that you have to live close enough to get two IV infusions a week while you are on the drug. The furthest I ever travelled to get it was when I was living in Delaware and the closest place was in New York City - I had to take the train 100 miles north and back twice a week, and that was a haul. The easiest is right now - I'm only 2 miles from Dr. Peterson's office!

      Good luck to you. I hope they make the drug more available.

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