Sunday, October 10, 2010

Written testimony to CFSAC 10/13/10

Testimony to the
Chronic Fatigue Syndrome Advisory Committee of the
Department of Health and Human Services
October 2010

Mary M. Schweitzer, Ph.D.

Thank you for allowing me time to speak.

I have XMRV.

I was one of the subjects who tested positive for the retrovirus in the Lombardi et al study published in Science October 9, 2009.

I first fell ill in 1990 while living in Delaware. I was a tenured professor at Villanova University outside Philadelphia. I had giardia followed by Epstein-Barr during an outbreak at my university. In the four years that followed, I had bronchitis eight months out of the year; I lost my sense of balance; the slightest bit of alcohol made me sick; I had increasing trouble falling asleep; and I could not do my usual Nautilus circuit and aerobic exercise without my pulse skyrocketing. Yet I had periods of health; I skied every winter.

Then, on October 24, 1994, I had a blackout in my office. When I came to, I could not understand a word of the essays in the bluebooks in my lap. It took fifteen minutes to be able to stand. I do not know how I made it home. My chair put me on short-term leave, which eventually became long-term disability. Although I was “resting,” I got worse instead of better. After a blackout while driving close to home left me and my car on top of a stone fence (and no memory of how I got there), I gave up my car keys. At first I could walk across a room; eventually I could only move about the house by leaning on walls, furniture, and my golden retriever. When outside my house, I was in a wheelchair. Increasingly, however, I could not go outside because I could not sit up that long. This is a very isolating disease.

I continued to have a social life on internet, because nobody could tell how long an email or website took to complete – and other brainfoggy patients didn’t mind misspellings or wrong words inserted into a sentence. By fall 1998, however, even internet was too hard.

About a year into my illness I developed Hashimoto’s thyroiditis. I also was found to have NMH/POTS. My Washington specialist, Dr. Marsha Wallace, treated the sleep problems, the thyroid problems, and the disautonomia, but I continued to deteriorate. Eventually I spent most of my time curled up in bed, in the dark, listening to a favorite movie (because it was too painful to look at the tv); severe pain behind my eyes, in the back of my neck; migraine-level headaches; and general muscle aches everywhere.

In 1996 I heard Dr. Robert Suhadolnik of Temple present on his new discovery, 37kDa Rnase-L, and I was fascinated. Two years later, Dr. Wallace arranged for Dr. Dharam Ablashi to have my blood spun down into a PMBC pellet to be sent to Redlabs in Belgium for testing; at the same time, Dr.Ablashi tested me for HHV-6, Variant A, which he had co-discovered at NCI. I was positive for both.

I had read that abnormal Rnase-L was a good predictor of success with an experimental immune modulator, Ampligen, an asymmetrical double-stranded synthetic RNA. I had also read a study by Dr. Ablashi and Dr. Paul Levine that had shown Ampligen inhibited the growth of HHV-6 in vitro. With that evidence to work with, I made the decision to go on the experimental drug. I was too sick for the double-blind study then being set up, but that was just as well – I wanted to know I was getting the drug.

I responded extraordinarily well. My brain began behaving normally within four months; soon I was driving and reading again. Eventually I would return to research, but I have never regained normal stamina. The slightest illness would set me back for weeks. Nevertheless, I could go places again with my husband; travel and see things; walk – walk on a beach, walk on a trail far enough that I did not hear the sound of automobiles anymore. If you have ever been confined to a wheelchair, you will know what that meant, to be able to walk again. I had dreamed of walking. And now I could stride.

Ampligen was expensive. After 20 months I quit taking it. I experienced what we Ampligen patients sometimes refer to as the “Ampligen Honeymoon” – I felt so normal and was so happy. I even negotiated with Villanova to return to teaching.

And then, on October 6, 2001, at Cal Ripken’s last baseball game, I had a blackout. The usher, who knew us, got me to First Aid and found Bob (who was visiting friends). Bob got the car while a nurse took me out in a wheelchair. The Disease was back.

The next morning I forgot what had happened and went to get out of bed as usual – but I fell to the floor. Six weeks later Dr. Ablashi confirmed that HHV-6, Variant A, was back. I could not send blood to Belgium, but the HHV-6 results were enough. I knew I had to get back on Ampligen.

The physician who had provided Ampligen in 1999 was no longer doing so, but I learned that I could receive Ampligen infusions at Hahnemann Hospital in Philadelphia, where they had permission for double-blinds because of Phase II’s on rare blood diseases. It took seven months, but I finally was on Ampligen again. I had deteriorated terribly, however. It was as if I had never been better at all.

So I had to climb back out again. After that, I was afraid to go off the drug. I remained on it from May 2002 to February 2008. Dr. Wallace had retired, so in 2005 I began seeing Dr. Dan Peterson at Incline Village (joking that the price of a ticket on Southwest Airlines was cheaper than Amtrak to NYC, my other choice).

The money is a problem – but it is roughly the same as my after-tax disability pay, so I live on the largesse of my husband, who is a chaired professor in a business school and does a lot of moonlighting – everything from teaching banking in executive ed programs to college lacrosse officiating and odd jobs for Major League Baseball. We manage.

But so few of my friends could afford the testing I’ve had, let alone the treatment. Every test for which I am positive is on the CDC’s hit list – that paragraph that states the test is inappropriate for CFS. Consequently, insurance won’t pay for those tests. At roughly $500 apiece, the expense adds up. Nobody can get tested, nobody can say they have what I have, and if they could, they couldn’t get treatment anyway. Pretty neat deal. For the insurance companies.

I continued to do well on Ampligen and made great progress on a book. Then my worst nightmare came true. In January 2008, dear Dr. Brodsky, now in his 80s, passed away. In February I received a phone call: FDA had taken away the drug. Hahnemann applied twice to get it reinstated, and I am not sure where the bottleneck was, but they were denied. Which means I was denied.

All the places where it used to be possible to get Ampligen on the East Coast were no longer in the program. Now I began to panic. I knew I was a ticking time bomb – I hoped perhaps I could stay relatively well for more than a year because I had been on it for so long, and I was so much better. I was wrong.

Seven months after losing Ampligen, in September 2008, I had my third episode of sudden onset. Once again I descended into hell. I lost the ability to walk normally and we had to bring the wheelchair back up from the basement. I dropped things, and when I tried to load the dishwasher I crashed one glass against another. The exertion of five minutes of testimony at the October 2008 CFSAC meeting sent me to the floor; my friends helped me lie down softly as I had once been able to help them. It made no difference that now I knew the names of the various symptoms – ataxia, expressive aphasia, short-term memory loss, central auditory processing dysfunction, etc. My brain had disappeared. And there was the exhaustion. And the pain. Pain, pain, pain.

I went to see Dr. Peterson at the end of September, and he put me through a series of tests. My MRI results were negative but I had an abnormal SPECT scan. My VO2 MAX stress test was below the level Social Security lists as an automatic disability for people far older than me. My Holter Monitor test was abnormal, and a 24-hour blood pressure and pulse test showed an NMH/POTS event when I was standing in line at the pharmacy – suddenly my systolic dropped 40 points while my pulse skyrocketed 40 points. (That was the first time I had ever seen a readout of it.)

I was active for Epstein-Barr (it goes dormant and reactivates over and over again if I am not on medication). I can now add a low natural killer cell count and a very low natural killer cell function (2%). More viruses had appeared – most seriously, HHV-7 and cytomegalovirus (CMV). I was also weakly positive for Coxsackie B2, B3, and B6. We did not find HHV-6 in my plasma, however.

During this period I went back to see Dr. Peterson every couple of months. I could do this only because of the kindness of the people who push wheelchairs for Southwest Airlines, the airport limo drivers and Tahoe taxi drivers, and the kind people who run a motel on the north shore of the lake, who have a family member with The Disease. When I was scheduled for a lot of testing, my daughter would fly up from Los Angeles to drive me around. Somehow we made it work. But I always came back home.

In the fall of 2008 Dr. Peterson tried Vistide, a drug that is approved for CMV. I had my first two doses a week apart while staying at Tahoe. He had then set up a dose at an infusion center connected to the only infectious disease practice in northern Delaware – but when I came for the infusion, they refused to give it to me. “I’m sorry,” the doctor said, “we can’t give you this. It’s a strong drug, and all you have is CFS.” But I have cytomegalovirus, and Vistide is approved for cytomegalovirus. “We know. And if you had something serious, like AIDS, or were on chemo from cancer, we would give it to you. But all you have is CFS.” But you told my specialist you would administer it to me. “Yes, but we hadn’t seen your files yet. We didn’t know you have CFS.”

I had to fly to Reno, spend the night, get my dose, and fly home.

But Vistide was not in the works for me. Ironically, while I seem to be the poster child for Ampligen, Vistide made my liver function tests go off the charts. My SGOT and SPGT counts were 500 times what they should ever be. They returned quickly to normal, so we tried a half dose of Vistide and then halved it again, but each time SGOT and SPGT spiked just as before. Vistide was out of the question.

In July 2009 I had a spinal tap - my daughter and her boyfriend came up from L.A. to help me again (Bob was just trying to earn money!). Aha – that’s where HHV-6 had been hiding out. So now I could say I ran the table – HHV-4, 5, 6 and 7.

At one point I remember saying to Dr. Peterson, it has to be my immune system. Something has to be really wrong with my immune system. Otherwise this does not make sense. He agreed, and then he said, “Oh, there are things I would like to tell you!”

Now, I will admit here that the very well-kept secret did not turn out to be what I was hoping for. I hoped desperately that Ampligen had by some miracle been approved. The finding that there was a retrovirus in 2/3 of a sample of 101 CFS patients completely bowled me over. That one I had not expected. And a few weeks later, by email, came the suggestion from a fellow patient that I ask WPI if I had been in the study. I assumed it was the Tahoe-Truckee cluster outbreak of 1984-85. Instead, they had deliberately picked zip codes from all over the place – so my Delaware zip code had bought me a free XMRV test. I was afraid to call and find out – not afraid to have it (I had plenty!) – afraid that I would not have it. Just as I had been afraid of the Rnase-L test 11 years earlier. The epithet of diagnosis-seeker only has meaning to someone who has never struggled to find treatment for a severe illness. XMRV means two things to me: an explanation for why I can’t go off Ampligen without getting sick, and the possibility of a substitute for Ampligen if FDA refuses to approve it. It means hope.

One more anecdote: During this period I fell, resulting in a slipped disk. (I fall a lot when sick.) I have a good neuro-spine surgeon at Penn, and he shaved a piece off quite neatly. But I was amazed at the response from the anesthesiologist, and later the nursing staff, to my warning that I had been diagnosed with a newly discovered retrovirus and they needed to take precautions. I was treated very differently than in the past – same symptoms, same litany of diseases and abnormalities, but now we had added a recognized disease (CMV) and a retrovirus (XMRV), and everything had changed. They were very happy to get me out of the hospital as fast as possible – so was I.

CMV and XMRV represent the first diagnoses I have ever had which turned heads among hospital staff. But as my daughter said when I told her about my new diagnoses, “you were sick long before anybody said what you had, Mom.” And she should know. She spent five years taking care of me.

Last year my husband, Dr. Peterson, and I decided that because I responded so well to Ampligen, I had to go back on it. That meant I was going to have to live in Incline Village, NV, until Ampligen became available at home again. It’s ironic – I live in the Northeast Corridor – 10 minutes from I-95, 5 minutes from a train station. I’m within driving and/or easy Amtrak distance from 40 percent of the nation’s population. But I had the choice of western North Carolina or a resort town on Lake Tahoe to be able to go back to the only medication that has ever worked for me. Since Dr. Peterson was my specialist, the choice was obvious. And I imagine I won’t get much sympathy for having to live at beautiful Lake Tahoe. But I have been married 35 years, and I miss my husband terribly. At our age, you feel like two heads of the same body. It’s awful. Thank heavens for unlimited long distance calling, MLB.com’s internet package, and Southwest Air.

I know that XMRV is “hot” right now, and dominates the discussion. But please remember that there are a number of immune biomarkers and viruses that we have that CDC also pretends don’t exist. They couldn’t find XMRV? I’m not surprised – they never could find HHV-6, natural killer cell dysfunction, mycoplasma, or NMH/POTS, either. It’s been the same thing for years: A quick study with a few patients chosen in a creative manner and then they can announce that X, Y, or Z is not “The Cause” of CFS. Why should it have been any different with XMRV?

But look at my history – and I am no different from many, many others with my disease who have also been able to get testing and treatment. I have some things others don’t have; others have things I don’t have. There’s a young man getting Ampligen with me who shares HHV-6 and the 37kDa Rnase-L (and XMRV) – but he also has parvo, which I don’t have, and myocarditis, which I hope I don’t have. There’s a pretty standard array of testing that works for us – that demonstrates a very serious set of biomedical abnormalities. What matters right now is not finding The Cause, but identifying patterns that can lead to treatment and improvement. That can turn around the downward spiral.

When you go to test whether XMRVs or PMRVs are related to the condition known as CFS (Fukuda 1994), please go back to everything else CDC has ruled out for the 25 years they have hidden this disease. This is important. Our lives are in your hands.

Thank you.

13 comments:

  1. Thank you, Mary. Thank you for taking the time and effort to write this testimony. I know how difficult it must be. Your blog is wonderful - I've learnt a lot from your intelligent, passionate and enlightening posts!

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  2. When, IF, clinical trials are started, they will need to keep track of all these abnormalities and look at all the sub-groups, won't they?

    That could be a good way to discover very quickly what type of treatment(s) work for each patient with specific biomarker profiles.

    Thanks, Mary, for once more being a guiding light to us all...may you get well and stay well!

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  3. Mary, This is magnificent. As always, your clarity and blunt honesty in telling your truth is so powerful. I pray it's heard. Thank you, a thousand times over, for all that you have done and do for us.

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  4. Mary, so glad you wrote this. You stand as further proof that Ampligen can be helpful for XMRV patients. If you look at my latest blog post: http://peggymunson.blogspot.com/2010/10/best-offense-is-good-offense-what-we.html#comments -- I posted a flier from the first ACT-UP action (on Wall Street) in 1987 -- which mentioned Ampligen (as a drug they were demanding access to!!!!!!). So, 23 years later, here we are, with a different retrovirus, and Ampligen only available to a handful of patients.

    Your statement, "XMRV means two things to me: an explanation for why I can’t go off Ampligen without getting sick, and the possibility of a substitute for Ampligen if FDA refuses to approve it. It means hope" is significant. Clearly, our bodies are acting AIDS-like when HHV-7 and CMV (and others) appear without immune modulation.

    I am glad you are still speaking out, especially about your Ampligen experience.

    Best, Peggy

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  5. Mary, this awesome. Inspirational, a huge help, tragic, incredibly well-informed. To read it is to be filled with rage at what is being done. It is so clear, so real, so penetrating , such an extraordinarily vivid account of your journey through the hell that is ME.

    What a document .

    Good luck .

    Greg

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  6. This went a little above my head, I don't understand what all the different viruses are and the different tests, in england its very much a diagnosis of illimination of anything else. But what i can do is feel for you, because we all have the struggles to get the drugs and the treatments, to pay the bills, to get through to ignorant doctors and friends alike that this is a real, terrible illness, not just "you've only go CFS"! I hope that things go well for you and you are able to get the drugs you need at home soon.
    thank you for telling your story.

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  7. Mary,
    Thank you for sharing this emotional story. I can relate to your 'wanting to test positive'. I also can't wait to see the results (and the faces of the non-believing physicians with a smurk on their face). You also convince me of the need for more bloodtests.
    Ampligen is not available over here, perhaps through dr. de Meirleir. dr. Peterson sounds fantastic, but is a bit far away. Hope to hear more from you. I wish you al the best.

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  8. For most of us with CFS, ss and private insurance have together pushed us out of homes, jobs, income, treatment and families, and created a silenced bunch of people riding the downward spiral together, while no one else even noticed the downdraft. We are mostly dependent, mostly too ill to socialize and mostly marginalized within society and our families. And we are mostly sick of being ignored. Thank you for your voice, and I hope someone in that room was listening.

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  9. I am so tired of the struggle. Thanks for keeping your voice out there.

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  10. please read Dr. Tarello's work on CFS in animals and Dr. Lindler's patents who claims he has found the cause of CFS and MS, but he is to busy trying to use this bacteria to make money that he hasn't bothered to try to kill it.

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  11. my email is ggigi70@hotmail.com. I live in Paducah, KY and didnt know who to go to when I moved here. I started getting sick in 2005, and wont get into details. However, I see a pattern here... In my early 20's -25 I had this disease and was massivly bed ridden, the jello legs, overtook my system, swollen lymphs, exc...doctors told me then early 90s it was either chronic fatigue or fibro...but was just kind of a depression thing, i would get over it. I started felling better about 6 years, they were always in the background but I was able to go on with my life and go back to college and get active then in 2005, it hit again...ive been bed-ridden since 2006, and its 2010, ive gained 50 lbs, and can no longer ride the trails. I think I also had this as a child. Early on in my 20's doctors, talked like this was no big deal, and when I got better, I forgot it. In 2004, I was biking trials 3 times a day...I could feel it catching up to me...I told my friend I didnt know what its name was but it was coming for me like before "and if it found me I would rather face a firing sqaud". I moved back closer to family. Thinking 1 year would help i would be back to my career. Its been 5. The doctors here say I am crazy...and most residents here say the doctors here are quacks and I need to go to bigger cities...I am wasting away. My 17 yo daughter its taking a toll on her emotionally to see me so strong, and i cant help them like i did, i cant clean , everything is turmoil here, and its my fault. I got sick. I honsently think this is what I am dealing with 150% but, ive exhausted $5000 to doctors i can hardley pay back on stuff i told them no on...no one listens. I think my kids are going to go crazy, or I am going to die, how do u manuever a 3 story house in a powerchair, manage a dog kennel, and go back to work FT , everyone expects it...your legs are like jello, and u cant get out of bed for 10 days, and u cant even get the dishes washed...its not depression, its just your body wont work that long, and then u do alittle bit, and your lungs start huffing. I just am so alone...

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  12. Gigi, you're not alone. But I do think you should be careful about spending money on doctors. I know the feeling of desperation, but it does no good to empty your bank account so that your doctor can make the payments on his/her Mercedes. Just do the best you can, dear. Let your family help out with the house, you see if you can't at least reduce your workload to part-time, and consider dropping the dog kennel. You are TOO SICK to do all of that stuff; you simply must stop caring what everyone else expects! Don't make your life harder than it already has to be. Hang in there, Gigi.

    Love,

    Catherine

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  13. I was diagnosed as HEPATITIS B carrier in 2013 with fibrosis of the
    liver already present. I started on antiviral medications which
    reduced the viral load initially. After a couple of years the virus
    became resistant. I started on HEPATITIS B Herbal treatment from
    ULTIMATE LIFE CLINIC (www.ultimatelifeclinic.com) in March, 2020. Their
    treatment totally reversed the virus. I did another blood test after
    the 6 months long treatment and tested negative to the virus. Amazing
    treatment! This treatment is a breakthrough for all HBV carriers.

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