Teetering on the Verge of TRAP (part 3 of Ms. Lab Rat’s Latest NIH adventure)

I didn’t jump into the TRAP trial eagerly.

When I first got a pamphlet from the National Institutes of Health advising me of my eligibility for a new study, I thought perhaps there’d been some mistake. This study was designed for people with progressive MS, the most serious form of multiple sclerosis, a most serious degenerative disease. That couldn’t apply to me. I was an MS success story. I was Ms. Lab Rat, the patient who had cleverly evaded a continued barrage of MS lesions by taking a fortuitous risk on an off-label drug. In over a decade of respite from new inflammation, neurologist after neurologist  told me I was doing everything right, told me I was doing great. None of them mentioned I was slipping into the progressive form of the disease.

And yet.

I myself had not been satisfied, had not felt I was doing everything I could to stop or slow the ongoing catastrophe that is MS. As much as I was grateful for the drug I was taking, I thought for sure that the drug had worked more efficiently when I first took it back in my late 30’s, when it was delivered off-label via IV infusion. The form of the drug that I later took for an NIH study, the form that eventually hit the market as Zinbryta, came in a little tiny vial, not a whopping big IV bag, and felt that much less miraculous. Sure, I was still avoiding MS relapses, but I was also no longer swimming for hours or taking long hikes. Or even short walks.

The cover of the NIH pamphlet asked, Is your MS progressing, in spite of treatments?

I wasn’t exactly sure.

Wouldn’t some neurologist have told me if my MS had become progressive?

One would think.

Would I have wanted them to?

Hell, no. Back in 2005, I fired a neurologist for telling me my MS was never going to get any better. Which started me on the search that led to Dr. Bielekova, who actually did make my MS get better, without ever making any promises that she could. She had prescribed the drug she was researching with great reluctance, because I’d been insistent. She’d warned me there was no guarantee of success. Yet it had been a success.

As I set the pamphlet down I saw Dr. Bielekova’s name was attached to the study. While I was still mostly in denial that the pamphlet could apply to me, I did have friends with progressive MS, friends who had lost their employment, much of their mobility, and in the worst case, much of their memory. Connecting them to an NIH study could give them access to some of the most nimble minds examining this insidious disease. I picked the pamphlet back up.

The trial proposed to measure the effects of four established medications, currently treatments for other diseases, to see if they could ameliorate the effects of MS. The drug that had changed the course of my disease had originally been used to keep the immune systems of organ transplant patients from attacking the transplanted organ; Dr. Bielekova had guessed that perhaps it could likewise be used to keep the immune systems of MS patients from self-attack. Clinical trial patients like me had helped to prove her theory correct. Apparently she was looking to repeat this success.

The pamphlet didn’t make any claims of how any of these four drugs might potentially help a person with MS. Instead, it went into detail about potential side effects. Which was all very above board. But not very tempting.

Furthermore, the timing of the pamphlet was off.

The pamphlet arrived in the spring, a time of hope. I had just enrolled in a clinical trial examining the effect of diet on MS. Wouldn’t it be wonderful if a teaspoon of cod-liver here, a sprig of seaweed there, would be all it took to fix me? I could only do one trial at a time. Why not stick with the wholesome one? The one without potential side effects.

When I called the number on the pamphlet, I disclosed my participation in the diet trial right away. I explained I was asking… for a friend. The doctor I spoke with was unfamiliar to me, but warm and sympathetic. She urged me to let the NIH pay to fly me out anyway, just to keep  updated on my progress with Zinbryta. I had nothing to lose beyond a wee bit of spinal fluid, which I would easily replenish. If there were signs of progression, I would qualify for the study. If it turned out I wasn’t progressing, well, that would be good information to have.

And that was how I’d wound up back at the NIH late last June for a spinal tap.

The results came in during the July 4 holidays. I got a voice mail message that I did indeed qualify for the study. The unspoken implication was clear. I could consider myself as having progressive MS. My calls to the clinic went unreturned. I blamed the holiday. Then summer vacations.

I didn’t want to admit to myself that I was devastated. I decided to look on the bright side. While the Swank Diet I was on for my current clinical trial wasn’t yet working any wonders, maybe its competitor, the Wahls Diet, would do the trick.  And if neither diet reversed my symptoms, at least there would be TRAP to turn to. If only someone from the clinic would return my calls.

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I got Swanked. Then I Wahled. Now I’m Galled.

 

When I started the trial to determine which diet was better for people with MS—Walhls or Swank—I’d promised the good people at the University of Iowa that I would not reveal which MS Diet I’d been assigned to until my participation in their clinical trial had ended. My contribution to trial has been completed. Drumroll, please.

I’d been assigned to the Swank Diet. For 36 weeks, I wrote a record of every morsel of food that passed through my lips. I ate no red meat, no avocado, no coconut in any form. No fats exceeding four teaspoons a day. I ate at least two servings of fruits and two of vegetables a day, as well as a minimum of four ounces of low fat protein, such as chicken breast. I drank no sodas, ate no sugars, no transfats, no deep fried food (OK, I cheated once and ate one half of the best falafel ball of my life.) I took the assigned five supplements: 1 tsp Carlson’s unsweetened cod liver oil, 5000 IU Vitamin D3, 1000mcg Methyl B12, 1000mcg Methyl Folate, and a Nature Made Multivitamin for Him 50+ ¯\_(ツ)_/¯.

I was to drink either skim milk (yech) or some milk substitute every day. After trying soy milk, then rejecting it based on scary stuff I read online, I moved on to rice milk, which I then rejected after reading more scary stuff online. I then turned to nut milks, which were a) yum and b) a little fatty…but by that time I’d lost more weight than the study wanted, so I’d hoped that would make drinking nut milk OK. I turned to the study nutritionist, who is supposed to help… but oddly enough, she deferred answering my nutrition questions until she’d checked with her boss, Dr. Wahls, who then expressly forbade her to guide me. Which led me to suspect… nothing nice. Dr. Wahls has a vested interest in the subjects given the Wahls Diet to succeed, and the Swank subjects to do poorly. Which is why I think it undermines the legitmacy of this very crucial study to have her at the helm. Well, Dr. Wahls, I did poorly.  Dr. Wahls calls those who follow her diet Wahls Warriors.  I guess I’ll consider myself a Wahls Martyr.

On my last study visit, the nutritionist asked me what advise I would give myself if I were just starting the study. I responded immediately. From my gut. I said, “Don’t do it.”

Aside from keeping track of what I ate every day, I had to keep track of my energy levels and my pain levels every day. My energy levels had gotten lower over the course of the study, and my pain levels remained fairly high.  The Swank Diet wasn’t right for me. It might have been a real improvement for another person with MS, someone who perhaps had weight to lose or had genuinely unhealthy habits to unlearn. But through thirty six weeks of deprivation of healthy fats, I’ve come to appreciate healthy fats all the more.

My first meal as a free woman was an avocado. I let bygones be bygones, and jumped right in to the Wahls Diet, diving right past level one to level 2/3. Thanksgiving came and went, and I ate (and abstained) as a Wahls Warrior should. Turkey? Yes! Organ meat? Yes! Good fats? Hell, yes. Neapolitan pizza and cannoli from New Haven’s renowned Wooster Street? No, thank you.

Was it worth it? It seemed like it. My energy level rose immediately. My pain level went down. I thought, This is the beginning of the rest of my life.

My new life lasted… ten days. The evening of Day Eleven, I got a fever. My side ached. Had I pulled a muscle in the gym? My whole body went cold. My fever worsened. I shivered. I called my primary care doctor the next morning. By the time I went in to see her, my fever was down. My side was still tender. Turned out, my white blood cell count was scary high.  My gallbladder scanned very clearly… and all they saw were some polyps.  My white blood cell count has since normalized, so I’ve opted for a wait-and-see approach instead of further scans. What did this incident mean? There are no clear answers yet. My gallbladder is still tender. My doctor has advised me to stay away from fats.

So for now, I’m on Wahls without the fun…I mean, the fat. Which is basically Swank plus organ meats plus seaweed. And no, I’m not chanting to myself, This is the beginning of the rest of my life. Though technically, it is.

Eat well, folks. Whatever that means for you. Stay healthy!

 

 

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Full Speed Ahead on MS Diet

After twelve weeks of anticipation, I finally learned which MS Diet I would be assigned for the duration of the study.

And the winner is…

confidential, at least until I complete the remaining six months of the trial.

I agreed to this stipulation, just as I agreed to injesting certain supplements, to saying yes to certain foods, to saying no to others. A clinical study is a group endeavor. Like any group endeavor, it comes with the perk of getting group support. Observe the above photo, in which I effortlessly glide above the lush tree canopy of the Arenal Volcano. Am I alone in this picture? Only because of how it is framed. A tico named Aaron suited me up, belted me in, and sent me on my way. A tico named Pépé was waiting for me on the other side. And a whole bunch of brave souls I never did meet set this whole contraption up in the first place with some fishing line and moxie.

My husband went ahead of me on the zip line. Unbeknownst to him,  I took some comfort in lighly touching the vibrating line as I watched him glide to the other side. I take no small comfort in having my husband accompany me on this MS adventure. I am grateful, too, for the many friends who have shown support and interest, and to my family of origin, who are all set to eat according to the diet when I fly in to visit them on Sunday. I do not take this challenge on alone.

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About to Launch

I am about to complete the Phase One, the Usual Diet phase, of the MS Diet study, which compares the efficacy of the Swank Diet with the Wahls Protocol in improving fatigue for people with multiple sclerosis (MS).

My husband and I concluded the Usual Diet Phase by going somewhere unusual. We’d never been to Costa Rica before. We wanted to eat our way through a new country without making any gringo requests for “gluten-free” anything. As it turned out, we ate very healthily there, and could have followed either diet without causing a stir. At one of the bed and breakfasts where we stayed, breakfast consisted of a neighbor’s eggs, seasoned with herbs growing in the kitchen garden, accompanied by juice squeezed fresh from oranges I’d picked myself in the backyard. And the coffee was picked right there in town. Food can’t get more local than that.  Yum! Costa Rica is a much healthier nation than the USA. (More on that in a later post.)

Tomorrow morning, my husband and I will take the seven hour road trip to Iowa City, IA, the site of the Diet Study.  This town has some sentimental value to us; it was here that I went to grad school, here where our only child was born. The hospital hold memories, too. It was here where I worked for the Telemedicine Resource Center, here where I had my first MRI, first lumar puncture, first spinal headache (when the puncture went wrong.) Here was where I got the diagnosis, twenty two years ago, that made me think I’d have less than ten years left outside a wheelchair. I’m still walking. But more slowly than I’d like.

On Wednesday, after my fasting blood is drawn, my food records are handed over, and my motor assessments are taken, my husband and I will meet with the study nutritionist, who will announce which diet we will be expected to adhere to for the next twenty four months. My hope, of course, is that whichever diet we get will reverse my disease course, that this will not be a mere twenty four month change, but the beginning of a lifetime shift. Are my hopes too high? My husband thinks so. He thinks we eat pretty darn healthy already. But he’s open to giving either diet a chance. I am so grateful for that.

The Swank Diet is a low saturated fat diet that eliminates red meat and high fat foods and includes whole grains and fat free dairy products. The Wahls Elimination Diet eliminates all grains, dairy, legumes, eggs, and nightshade vegetables/spices. Both diets include fruits and vegetables and dietary supplements.

Wish us luck!

The Skinny on the WAhls VErses Swank Diet (WAVES Study)

Last week, I drove 475 miles to The Preventative Intervention Center at the University of Iowa to participate in Phase 1 of the WAVES (WAhls VErses Swank) MS diet study. My participation will last 36 weeks, assuming I make it through Phase 1, the Usual Diet Phase. If I do, I will be expected to visit the clinic every 12 weeks through the conclusion.

The WAVES study is open to people with relapsing/remitting multiple sclerosis (MS) who experience MS related fatigue. The purpose of the study is to compare two dietary approaches to see which diet is more successful at reducing fatigue. The hypothesis is that consuming one of the study diets will reduce MS related fatigue, improve energy and improve quality of life.

The bias of the experimenters for the Wahls diet remains unexpressed in the literature they hand out to us lab rats. (Well, the nitpicky can find bias revealed in the name WAhls contributing the first two letters to the WAVES acronym, whist the name Swank is contributes only one. I am not that nitpicky.)

On my next visit, I will be randomly assigned one of the two diets, and must then commit to following that diet exclusively. The twist: my super indulgent husband will also have to commit to following whichever diet, at least for every meal he has at home. Because this is a blind randomized study, I can’t let the administrators know which diet I’ve been assigned. This means, gentle reader, I can’t let you know either, on the very off chance that the study administrators don’t have anything better to do than check an amateur blog. (This is where I lose you, dear reader, and you suddenly remember you had meant to be curing cancer at the moment. Godspeed!)

While I can’t help but assume that the WAVES study is biased toward the Wahls Protocol, since Wahls herself designed it, I myself do not share this bias. Well…maybe a teensy bit. A very healthy, very active, once diseased Dr. Wahls does make a fine case for her diet in her TED Talk, which I watched to its completion many years ago. I am sure there is an equally compelling case for the Swank diet in the book I couldn’t bear to finish, which currently collects dust on my bedside table. (The issue of my reluctance to fully research either study will make another blog post eventually. Or a podcast.)

If I do get assigned the Wahls Protocol, I will be happy, because it is so intimidating and involved, I feel I will need the challenge of doing my due diligence as a Lab Rat to actually see it through. (In addition, I can lean on the professional assistance of the study nutritionist, who will assign me the diet and will keep this random assignment to herself.)

If I get assigned the Swank Diet, my husband, for one, will be happier, since he’s concluded (from his 14 second scan of the description) that this diet is more in line with the one we already follow. I am going to need his support, so I would be grateful for an option he finds palatable

Here are the diet descriptions, straight from the 22 page consent form:

“One diet is a low saturated fat diet that eliminates beef and pork and includes whole grains, fat free dairy, vegetables and fruits (Swank) and the other is a modified paleo diet (Wahls Elimination) that eliminates all grains, legumes (e.g., beans), eggs, dairy, and nightshade vegetables (tomatoes, potatoes, eggplant, peppers) and stresses more vegetables and meat in the diet.”

If you were assigned one of these two diets, which would you be more willing to follow for 24 weeks?

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The MS Diet Study: A Radical Idea

I value this study of the effect of diet on MS, not the least because it is radical. It isn’t often a rigorous clinical trial is run in which the end goal is not a marketable commodity in the form of a drug.

The end goal of this trial is patient health. It’s not about profits. There’s no cookbook cabal conspiring to profit from the chronically ill. Sure, a few thousand farmers markets may see a rise in sales of organic produce. No harm there. The fish oil industry may get a bump. But overall, no single party involved in the outcome stands to gain as much as wealth as Big Pharma does every time they release a new medication they can sell to captive consumers for as much as $7000 per month.

And yet: if you are to follow this link to the logical, researched TED Talk by the inventor of the Wahls diet, you will encounter a red warning label superimposed over the opening frame:

“Note from TED: This talk, which features health advice based on a personal narrative, has been flagged as potentially outside TED’s curatorial guidelines. Viewer discretion advised.”

And if you follow this link to learn more about the Swank Diet, Wikipedia will inform you, “The widespread claims made for the diet have not been substantiated by independent medical research.”

The good news: this MS Society sponsored clinical trial is being administered by the University of Iowa, and should finally provide the objective substantiation all people with MS deserve.

And while Big Pharma might not have much to gain financially from the results of this study, that doesn’t mean this study, if successful, won’t have a mighty economic impact. If we trial participants regain our health by merely adjusting our diets; if we leave our walkers and our reclining wheelchairs and our social security checks and go back to full time work, to do whatever it was we were schooled in, and trained for, if we can once again have the freedom to follow our dreams—we will be more effective than any worker who has had the luxury of taking health for granted. And if those $7,000/mo drugs are no longer needed, that will go a long way to correcting our nation’s disgracefully costly health care system.

Follow this link to Dr. Wahl’s rebuttal of the TED Talk warning.

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Wahls Elimination Diet vs Swank Diet: Which Is the More Effective Treatment for MS Related Fatigue? Ms. Lab Rat jumps into the maze.

Some Background (faithful readers can skip to paragraph 5):

As my faithful readers know, I am a machine with faulty wiring. Multiple Sclerosis has somehow managed to convince my T-cells to attack the insulation that surrounds the nerves conducting all the information my body needs to function optimally. This insulation is called myelin, and my myelin is ratty with scars. (Multiple sclerosis=many scars.)

When I got the diagnosis, I refused to accept my fate. I tried the first medication I was offered. And when that didn’t work, I tried a second. And when that didn’t work, I entered a clinical study of a new medication, one, I was told, that really made a difference. But as will happen 50% of the time with clinical studies, it turned out I was assigned to the control group. I didn’t get the new medication. I got a placebo. And I got more scars.

I not only tried new medications, I tried new doctors. (I moved around a lot, at first, so that part could not be helped.) When my fourth neurologist gave me the dour news that I was doing very badly, and could expect to do worse, and then much worse until I died, well, I switched to a cheerier doctor. Who gave me the same dire news, but with a big smile. I dumped her, too. Instead I found a brilliant researcher, Bibiana Bielekova. Researchers are always looking for better ways to do things. So am I.

Long story short, I talked Dr. Bielekova into letting me try an off-label drug that worked with the immune system, rather than fight it. Daclizumab works by boosting the population of Natural Killer Cells, which function like the good cops in the Wild West of my immune system; the Natural Killer Cells keep the rouge T-Cells, or bad cops, at bay. Daclizumab worked. The T-Cells stopped attacking my myelin. Eventually, the National Institutes of Health (NIH) funded a study of Daclizumab. I was lucky enough to join the safety arm of the study, so I was assured a constant supply of Daclizumab. In the last ten years, this medication has been so effective, the T-cells have only once managed to create a new scar. Earlier this year, the FDA apporved Daclizumab under the name Zinbryta. On the day I injected my last dose of free study medication, I was accepted into a new clinical trial.

Faithful readers, jump in here:

Finding a drug that stabilized my MS only solved half of my problem. While my T-cells have stopped chewing on the fatty myelin that insulates my nerves, the many scars created by years of insatiable gobbling still interrupt the signals of my central nervous system. I have to cope with fatigue, pain, lack of coordination and balance, and a digestive system that’s out to lunch. Oh yes, and a brain that continues to shrink. You would think, then, that a person as proactive as I am would have immediately acted when I saw a very convincing TED Talk by a smart researcher who overcame an even worse case of MS than mine. Like me, Dr. Terry Wahls took the latest greatest MS medication. And like me, her MS only got worse. Dr. Wahls soon found herself confined to a tilt-recline wheelchair. Unlike me, Dr. Wahls is a physician. She read the latest medical research about diseases in which brains shrink. She read studies in which animal brains had been protected from shrinkage using fish oil, creatine, and co-enzyme Q-10. She started taking human proportioned dosages of these substances, and started getting better. This was her first round of self-experimentation. Slowly but surely, she tweaked her diet to include and exclude certain nutrients and ultimately found herself out of the wheelchair, biking to a full day of work as a doctor, and, of course, promoting the diet that saved her. She managed to get the Multiple Sclerosis Society to chip in 1 million dollars to fund a scientific study to compare her diet with the Swank Diet, one that has been  found to help people with MS for decades. I, who was somehow too intimidated years ago to follow the Wahls Protocol, have now agreed to be part of this study, which is going to be a much more onerous and complicated option than simply buying her book and following along. How much more onerous and complicated? I’ll share the details in my next post. But strange as it is, a Lab Rat is a Lab Rat. I would rather experiment on my diet in a study as a contribution to the greater public knowledge than to simply tinker with the diet on my own.

How about you? Have you ever participated in a clincial trial? Would you?