Wednesday, October 27, 2010

Breaking Out!

There was a prison breakout in the USA this past weekend of historic proportion. And like most escapes that require patience and tenacity, this one took 10 long months of preparation. But when the time came, the escapee acted almost without thinking, and ran with freedom in his eyes, and hope burning in his heart. No, this isn't the story of a convicted felon escaping from the County jail. Although it did have to do with a guy escaping from his incarcerated state. 

This is the story of me, doing something absolutely insane this past weekend. Something that was seminal to my progress, critical to my healing process,  and something I felt I just had to do. After 10 long months being "stuck" in this place, last Thursday, I made a run for it. I escaped!

On a whim, after my Ampligen infusion last Thursday I went to the airport, bought a ticket for a 4 hour non-stop flight, and flew to Denver, Colorado! By myself! I then rented a car, drove an hour North, and spent the weekend in beautiful Ft. Collins, enjoying the crisp clean air underneath the majestic Rocky mountains.Yes, this means that I had enough energy and cognitive ability to follow a map to a place I'd never been, check into a hotel, and live at mile-high altitude. Yes, this means that the Ampligen is working better than advertised, and that my health is actually being restored.  But it also meant something else of equal importance. Let me explain.

To say I have felt like a horse cooped up in a corral for the past 10 months would not be an exaggeration. As you know, when I moved here to begin the twice-weekly Ampligen infusion protocol, I could barely walk. Because my wife couldn't stay with me full time in this new town,  we hired a cook and a maid to help me. That I needed this level of assistance when I started was not over-kill;  I literally could not stand long enough to fry myself an egg ten months ago. Apart from going to the clinic every Monday and Thursday to get pricked by Gwen, for the first six months I was pretty much a one-trick pony. Week after week I would live on the couch, leaving my "pen" only to go to the clinic, and occasionally to church on Sunday.  Having the helpers was awesome, but I still felt like I was in a modern prison. 

As I've written about previously, after 6 months, something changed. The side effects started to abate. Energy slowly returned. I initiated a very slow program of exercise, walking and going to the gym near my apartment. I stopped the services of my cook, and began shopping and cooking for myself (bachelor-style). I let my maid go, and have lived without help for over 6 weeks now. In short, I started to experience a taste of "normal" life - a free life -  for the first time in a very long time! But that small taste of freedom presented me with a problem.

You see, although I was actually starting to take baby steps toward living a healed life,  as clearly evidenced in my actions and in my body, my mind was still 'stuck' in protective mode; "sick" mode.  Call it habit or fear or both, even though I could see myself making lots of progress, I was still scared.
  • Scared that the healing would be short-lived;
  • Scared that if I did just one more thing, I would crash; 
  • Scared that after all this time, I wouldn't remember how to live!
That fear and self-protection habit was like a chain around my heart. If faith is the evidence of things not yet seen, then fear is the doubt of things already known. And I clearly was still acting like a sick person, imprisoned by my limitations. Even though the evidence said otherwise.

It came to a head last week when a social activity was presented to me and I turned it down immediately...out of habit! Despite all my test scores and charts* showing amazing progress, despite 6 full weeks of living independently and going to the gym everyday with energy, despite aching for friends and social interaction, when they asked if I could go, I said as I had so many times in the past, "no, I better not." 

Ten seconds later it hit me. "What was I thinking????"  I had gotten so good at living "within" my limitations, I couldn't break out of my limitations. I was an expert at living like a sick person! And it infuriated me. 

Here I was at Week 40 on the Ampligen protocol, with 20 years of published research telling me that people were healed on Ampligen by Week 40, yet I still was on guard.  Here I was with six full weeks of independent living, yet I was still playing it "safe." Like the men released from prison who still sleep on the floor after being released from incarceration, even though they now have a bed, I was trapped by the habits learned over years of sickness. Those habits protected me at the time, clearly. They probably kept me alive. But now, they were like quicksand, keeping me "stuck" in a place I should no longer be.

Years ago, long before I got sick, I was trapped in quicksand once. Well, more accurately, my horse Gypsy was trapped in quicksand, with me on her back. Both the horse and I knew the serious trouble we were in, as we sank immediately up to the top of my boots, and then kept sinking about an inch per second. Gypsy thrashed at first, but that only made things worse.  Thankfully, I was with an experienced equestrian, my best friend Ed, who as a cowboy in Arizona knew exactly what to do.

Dismounting and coming over to me while still on dry land, he leaned carefully over, grabbed the reins from the bit, stood slightly to the right in front of Gypsy's good eye, and smiled at her. By this time the quicksand was inching close to my knees, and both the horse, and I, were getting nervous.

Then Ed said something I thought at the time was the most ridiculous thing I could have heard at that moment.

"We have to get her mind off the sinking, and on to the running." Ed said seriously. "She's a racer at heart" he continued, "so we have to get her brain out of that there quicksand, and her body will follow."

Because Ed was my only hope, I decided against vocalizing either my doubts about his idea, or asking him why he said "that there" when as a Scottsdale native his English was normally otherwise perfect. Instead I just asked "How do we do that?"

"Well, on the count of tree" Ed said smiling, clearly enjoying this cowboy twang he decided to adopt at this moment, "I'll fire off my pistola here, and you give her a good kick in the hindquarter with your spurs, and she'll think she's in a race, and just run right out!"

Ignoring the fact that I wasn't wearing spurs, and only because I had no other bright idea, I did what Ed said. Pulling my legs out of the muck slowly and positioning my boots backwards, when Ed reached the count of "tree", I gave Gypsy the hardest kick I could muster, just in time for her to hear Ed's .357 "crack" like an explosion.

Amazingly, Gypsy did exactly as Ed had predicted. In one giant thrust, she jumped or hoisted her front legs violently out of the muck up onto the dry land, leveraged her remaining 2000 pound rear out of the quicksand, got her back legs grounded, and took off running!  With me grabbing her mane and holding on for dear life, we ran around that bog in a giant circle at least three times - Gypsy so thrilled with her freedom and the thought of racing that she simply carved her own curved track in the desert!

Leaving the clinic this past Thursday, the thought of facing another long weekend alone in my apartment, combined with the recollection of my stupid knee-jerk rejection of a social invitation, was enough to make me say to myself, "enough!" I had to break out of this place I was stuck in. I had to get my mind out of the muck. 

I didn't have the sound of a gun going off to snap me out of it. But I did give myself a giant kick in the butt - and when I boarded that plane to Denver, I started to feel my legs find solid ground. When I got off the plane with no luggage whatsoever, and entered that gorgeous DIA terminal, you couldn't stop me. I jogged down the ramp grinning from ear to ear, passing the people mover like I was Gypsy, out of the sinkhole, racing again. 

Until this past weekend, I was sort of stuck in a quicksand of my own making. And I needed something to get "my mind off the sinking, and on to the running." Because just like Gypsy, before I got sick, I too was a runner at heart.

This short spontaneous trip to Denver did it for me, and it was glorious. I had a super three day vacation, with no pain, no loss of energy, no feelings of being stuck. When you compare my life to where I was 10 months ago, it's almost miraculous! Yet of all the tests I've taken, this was the test that really confirmed for me this amazing drug Ampligen is really working! 

Now for these final 3 months of treatment, I know what my job is. As long as I can keep my brain out of that there quicksand, my body will follow.

*Below is my personal comparison chart that shows my progress over the past ten months, comparing when I arrived and started Ampligen in January, and today. The clinic keeps detailed records and measures all Ampligen patient's progress through a number of empirical tests, regular blood work, EKGs, a running Karnofsky Score, and other physical exams and tests. However that information under the terms of the "trial protocol" cannot be revealed here. My guess is that the chart below would simply confirm that which the clinic has in their records about my progress. 

Friday, October 1, 2010

Interview with Dr. Lapp - A Pioneer and Patriarch

To give you an idea how long Chuck Lapp has been serving the CFS/ME community, think about this - Before Steve Jobs invented the Macintosh Computer, Dr. Charles Lapp was contacting the CDS about a mysterious new illness. Dr. Lapp has been treating and specializing in CFS patients for over 25 years. He was one of the founders of the CFIDS Association in Charlotte, and continues to be one of the leading physicians in the field, always on the cutting edge of new therapies and drug trials. In the USA today, only 2 physicians are administering the drug Ampligen, Dr. Lapp in Charlotte,  and Dr. Peterson in Reno. We caught up with Chuck Lapp as he was on his way to a speaking engagement in Atlanta. 

Kelvin: Dr. Lapp, you have been specializing in this disease for over two decades, and moved to Charlotte in the early 1990's to team up with Dr. Cheney to launch the first group of physicians who took this infirmity seriously. Tell us about those days. 

Dr. Lapp: I saw my first patients with this disease in 1983, and began researching CFS in earnest in 1985. I made contact with Paul Cheney at that time and we started seeing patients together around 1988. Although at that time I was commuting back and forth between Raleigh and Charlotte, where I ran a large family practice. In late 1991 I moved full time to Charlotte, where the Ampligen studies had just begun, and I was placed in charge of the Ampligen patients. Dave Bell joined us for 2 years as I recall between 1989 and 1991. Dr. Myra Preston also shared office space with us. When Marc Iverson's CFS support group started growing, we used it as the base for launching what today is known as CAA or the CFIDS Association. 

Kelvin: You mentioned in the past that in those early days, you and Cheney were trying everything you could think of to help CFS/ME patients. Like Edison with his light bulb, you had many things that did NOT work, and some that did. Tell us about some of those. 

Dr. Lapp: I counted it up and there were over 120 "ideas" we tested or researched, based on what we read in journals, or heard at meetings with other physicians. As you know, in those days, very little was known about the disease, so we were trying everything we could just to help patients. For example some of the treatments we discovered that did help included: 
  • B12- helped
  • Dietary changes- helped
  • CoQ10 and Krebs Cycle intermediates such as malate and magnesium-helped
  • Aquatherapy-usually helped a lot!
  • Of course beginning with the trials in 1991, Ampligen showed great promise
Some of the things that did not work out well included:
  • Oral Interferon- some patients got worse
  • Ambotrose/Mannatech- no help
  • Heparin for presumed excess histamine and coag problems - no help
  • Ocytocin- minimal help
  • Treating oxidation radicals- no help
I should tell you that there were loads of "theories" floating around as well, many of them we put to the test. For example, NONE of these theories panned out: 
  • "AIDS Minor" or idiopathic C4 Lymphophenia
  • Sedimentation rate as a marker for CFS
  • Urine pH as a marker for CFS
  • Stealth (foamy) virus
Kelvin: With almost 20 years experience treating patients with Ampligen, in general what results have you seen? 

Dr. Lapp: You know that FDA regulations limit what I can say publicly- during a trial period we are restricted as to what we can reveal about any drug before it receives approval, so I have to be careful here. On our site at the Hunter Hopkins Center we quote the Medical Director of Hemispherx Biopharma who said based on their research "Ampligen may be the first drug to demonstrate safety and effectiveness in the treatment of CFS." But I would tell you that our overall experience with Ampligen has been good. We have patients who have made remarkable improvements; patients who have made modest improvements, and patients who have made no improvement at all. Overall the drug has been well tolerated. I cannot recall  anyone who got worse on Ampligen.  It is interesting to note that with the latest news whirlwind regarding CFS and the XMRV virus, that in early September 2010 Hemispherx posted a study where test subjects receiving Ampligen who were XMRV antibody positive performed better on exercise tests than the others. We're still waiting for more data on that, but readers can see all the details on the CFIDS Association website.

Kelvin: What makes Ampligen different than all the other treatments you've used over the years? 
Dr. Lapp: It is not clear how Ampligen actually works, but the drug is known to have antiviral and immune modulating properties. Preliminary studies ahve shown activity against retroviruses (like HIV) as well. Ampligen also modulates interferon-induced RNaseL and PKR antiviral systems of the body, which have been closely associated with CFS. Most importantly, Ampligen is the only medication that has undergone rigorous study for the treatment of CFS, not just treatment of CFS symptoms.

Kelvin: You don't accept all patients who want Ampligen. What makes for a good Ampligen candidate? 
Dr. Lapp: The only way to obtain Ampligen today is to enter an FDA-approved research study known as AMP-511. This is a cost recovery program, which means that researchers are required to recover the cost of  treatment from the patient. Previously this program was known as "compassionate care." This type of program requires patients be very ill and have not responded to reasonable previous treatments. specific exclusionary and inclusion criteria are specified by the FDA, and can be viewed by going to and search on Trial NCT00125813

Kelvin: Dr. Lapp, you are one of the few Doctors who has not only met Dr. Carter and the rest of the lead staff at Hemispherx Biopharma, but have had a relationship with them for almost 2 decades. What in your opinion is the future of Ampligen? Can you give us any hope that it will be approved, and finally made available to patients beyond the "cost recovery" program? 
Dr. Lapp: Yes, I can. Again, I am limited by regulation as to how much I can say, but let me say this... Last December the FDA responded to Hemispherx's New Drug Application with a "Complete Response Letter." This letter provided recommendations for improving the application, which implies that the drug is ultimately approvable. The Complete Response Letter suggested that Hemispherx perform one more study and clear up some questions about drug safety - specifically effects on immune activation and carcinogenicity. Dr. Carter, Dr. strayer, and senior members in the company all indicated that Hemispherx wants to pursue approval and has the wherewithal to do that.

Kelvin: When I search "Google Scholar" I see there are a number of published, journal articles on the efficacy of Ampligen in combination with other drugs. For example, last year during the swine flu scare, Ampligen was shown to augment flu medications, and make them work faster. In the future, if Ampligen is approved, could you see patients using Ampligen in combination with other treatments? 
Dr. Lapp: Oh yes, absolutely. In the early days of CFS research, all the CFS guys and all the HIV guys would meet together, because Ampligen could potentiate so many of the AIDS medications. We've known this for years. So once approved, combination therapy with Ampligen would be a natural, a given.

Kelvin: OK, Dr. Lapp, last question. You are known for your compassion for patients with CFS/ME. You often absorb your own incidental costs related to Ampligen infusions, you have been known to let out of town patients stay at your home, you have resisted raising your prices for years, and you even have made house calls. What is the root of that generosity? 
Dr. Lapp: Well, you know I have great empathy for CFS sufferers. I don't know that "generosity" is the right word though. More appropriately it is a desire to find a cure for this heinous illness and to make promising therapies available and affordable. The cost of receiving Ampligen in our clinic is $2000/month and many insurers will cover a large part of that cost. All medicine is expensive these days, but when you consider that the costs for treating rheumatoid arthritis, MS, cancer and other disorders are many times more expensive, it puts it into a different perspective I guess. We do all we can here to make treatment as affordable and available to our patients as possible. We have had patients come here to Charlotte, move here in fact, from all over the world, to get Ampligen. One of the things I love telling potential patients who are considering Ampligen is how compassionate our entire staff is. As hundreds of her followers and patients know, Dr. Black, who also administrates our Facebook site has a special empathy for our patients. And all of our Ampligen patients know and love Wendy, who they see twice a week for infusions. She is literally sticking them with needles every Monday and Thursday, and yet they all smile when they see her!  I think that's what sets our office here at Hunter Hopkins Center apart from others. 

Kelvin: Thank you Dr. Lapp.