Why Do I Always Opt to Join the Trial?

You can always rely on me — to join a clinical trial. If there’s a choice, say, between starting an MS diet and starting a clinical trial of an MS diet, I’ll opt to join the clinical trial. (I still regret that diet trial.)

When Dr. W told me I’d have to stay on an MS drug to be part of the TRAP trial, I didn’t consider dropping the TRAP trial. I went right back on Tecfidera with nary a reservation. I was finished with being flummoxed. My reservations about Tecfidera were suddenly forgotten—like my initial reservations about the TRAP trial.

When I’d first seen the letter from the NIH addressed to me as a candidate for the TRAP trial, I’d thought — no, hoped — they had sent it to the wrong person. Because this was a trial for people with progressive MS. I didn’t have progressive MS. I had the sportier version of MS—relapsing/remitting—and I hadn’t relapsed in years. I was a success story. Wasn’t I?

At that point, I had just joined the Wahls Diet trial. I intended to eat my way out of MS. And of course, since I was doing this dieting through a clinical trial, and not through a cookbook, this meant the outside world, including the NIH, would benefit from the data I’d contribute as I healed myself, one cup of veggies, one sprig of seaweed, at a time.

Well, over one thousand cups of veggies later, I have come to accept that I have progressive MS. This doesn’t mean what I’d thought it meant. Apparently I can still pass as able-bodied. (I got some affirmation just an hour ago, when my husband and I were out walking our dogs and a neighbor made some comment about my power-walking with my trekking poles. She and her husband were genuinely surprised/alarmed when I told them I was using those poles because I have MS.)

The progression of my MS might still be invisible on the outside, but MRIs detect gradually worsening brain atrophy. Lumbar punctures detect the breakdown of the mitochondria in my cells. I detect, in a myriad of subtle ways, that I am moving with greater difficulty through the world.

Current MS medications address one aspect of MS — they are measured in their ability to prevent relapse. They do nothing to address the brain atrophy and cellular damage that accrues over the years. The researchers at the NIH want to address all aspects of MS. The TRAP trial looks at four medications that might work to supplement the treatments that are already out there. Pioglitazone, Montelukast, Hydroxychloroquine, and Losartan have already been FDA approved for other diseases, and may have properties that could assist against MS.

In the future, MS patients may take multiple drugs instead of just one, much as AIDS patients do today. And while I am not jumping up and down for joy at the idea of us MS patients adding more drug burden to our already overtaxed bodies, I am even less willing to add more disease burden to my already overtaxed central nervous system. If I need to take an MS drug to be a part of the TRAP trial, I’m willing to stick with Tecfidera. The drug I’d be paired with, Montelukast, aka Singulair, has been shown to rejuvenate the brains of old rats in clinical trials. This old Lab Rat wants to give it a try. I could use some rejuvenation.

The funny thing is, I don’t have to rejoin the trial to take Montelukast. I could go to my GP, who likes me well enough, complain of a runny nose, and get prescription for Singulair. With the NIH out of the loop, I could skip taking Tecfidera, not to mention all those MRI’s. I could do my own brain hack.

Why don’t I? The same reason I don’t do my own plumbing. I need the best minds I can find to keep me out of deep shit.

In this trial, the researchers are going to see if they can get the same cellular information from tears as they do from spinal fluid. No more lumbar punctures? Now that’s progress—the good kind.

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Breakfast Break: MS Style (part 4 of Ms. Lab Rat’s Latest NIH Adventure)

When we last left off, I, Ms. Lab Rat, was sniffing the sickly scent of powdered sugar as I passed the by-now stale gingerbread houses on display in the secular cathedral that is the NIH (National Institutes of Health.) I had time to kill before my Phlebotomy appointment, so I took the elevator to the second floor cafeteria, which has an excellent salad bar. And discovered I was too early for salad.

Here’s the deal with my new Wahls-inspired MS diet: the foods I used to associate with breakfast are off the menu. No processed foods, no gluten, no grains, no milk (bye bye breakfast cereals,) no eggs, no cheese (bye bye omelets.)

Here is a picture of what breakfast looked like for me today: IMG_9271

You’re looking at bok choy and garlic escargot simmered in homemade chicken broth, topped with kimchi and dulce. The Wahls Diet calls for the consumption of four servings of leafy green veggies a day, at least four servings of colorful fruits and veggies, a meat, a touch of seaweed, a bit of something pickled. The Wahls Diet is also very very big on homemade bone broth. So this breakfast covers pretty much all the bases. (If I were a true purest, there would have been a little knob of organ meat floating around in the bowl, too. But that’s the thing about the Wahls diet. Or maybe any diet? You can always feel you’re not quite up to par.) This breakfast was yummy, by the way. But this kind of breakfast is not easily obtained on the road. Not even in a hospital. (By the way, what’s up with hospital food? Why are there so many unhealthy choices? Topic for another blog.)

Here’s a fuller, indeed cluttered picture of what breakfast looked like for me today, when I tell the whole complicated story of my MS maintenance:

IMG_9272

You are still looking at my pretty bowl of healthier-than-thou breakfast food. You are also looking at the supplements required for the clinical trial of the Wahls Diet:

5,000 IU Vitamin D3, 1 t cod liver oil, 5000 liquid vitamin B12, 1 mg folate, multi-vitamin.

Then there’s all the stuff I have to take for my funny bladder:

AZO, macrobid, and some other antibiotic I’ll be finished with at dinner.

Then all the stuff I choose to take for my self-designed Ms Lab Rat trial:

3x 100 mg Biotin (which I am hoping will eventually fix my bladder problems and get rid of three of the items above), 500 mg Hemp oil, local hemp oil, glorious hemp oil (which has helped me sleep and dream after many sleepscarce, dreamless years), 5 mg Lithium (which I thought was doing a fine job as a mood stabilizer, though I just learned that what I take isn’t anything like a mood stabilizing dose. So let’s call it my placebo.)

This is a lot to keep track of. When I graduated from the Swank Vs. Wahls clinical trial, I got a certificate (no joke) and a private viewing of a 20 minute video of Dr. Wahls that just served to delay the seven hour drive ahead of me. No t-shirt. The only remotely useful thing I left with was a booklet to help me keep up with all the details of living in a Wahls Diet world. (I had rallied hard for an app, but there isn’t one. Yet.)  For a few weeks afterward, I kept filling in little circles every time I popped another supplement, or finished another serving of leafy greens. But eventually I ditched the booklet. I want to feel a little less obsessive, a little less persnickety. Either that, or I’d already assimilated all the expectations. My brain had become the diet app I’d been asking for.

The morning of my TRAP trial, I realized I was not going to get a Wahls breakfast, or Wahls-ish breakfast before my blood draw. I guzzled a “green” drink I purchased from a vending machine and took the elevator down to Phlebotomy. A lovely woman handed me a white stub with a number. As I glanced down to read 32, she called, “Thirty two.” It was the Christmas holiday. I was the only patient in the waiting room. I filed past untouched trays of cookies and two pots of coffee and entered the orderly hive of numbered white cubicles, wondering if I’d recognize my phlebotomist. I had been there many times before.

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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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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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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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Once A Lab Rat, Always a Lab Rat

The NIH study that has nurtured me since 2010 is over. The day I’ve been anticipating with measured trepidation has finally arrived. A few hours ago, I took the last of the vials of free medication from the NIH out of my refrigerator, and injected.

If the drug had not passed the FDA approval process, this would have been a very sad day. But it did pass. The fruition of the study is available commercially as Zinbryta. Dr. Z., my neurologist, has already set in motion a smooth transition for me; I’ll be the first of his MS patients to purchase Zinbryta. I won’t have to miss a dose of the drug that has given me my life back.

So today, then, marks the happy ending to my life as a Lab Rat?

Not so fast.

Today marks the closing of one chapter. And the opening of another.

This morning I received a phone call from a research assistant named Brianna. She asked me ten easy questions designed to provoke pleasant answers, such as, “Today is Tuesday, September 15, 2016” and, “Barack Obama is the President of the United States.” At the end of this quiz, I found myself qualified to be a Lab Rat in the MS Diet Study.

As any faithful reader of this blog knows, I am very interested in the role of diet in the management of MS. I’ve been intrigued by the Wahls Diet since seeing Dr. Wahl’s TED talk; I couldn’t help but be impressed that she has managed to eat her way out of a reclining wheelchair and back to full time medical practice.

This study will randomly assign me to either the Wahls Diet or the Swank Diet. As it happens, I am comfortable with both. Dr. Z. has met many people with MS leading active, healthy lives on the Swank diet. It will be a win for me either way.

I don’t have to ditch Zinbryta to participate.

Could a lab rat be any luckier?

Another fun perk of this study: I will be traveling to Iowa City, home of the Iowa Writer’s Workshop, where I got my MFA in fiction, and, come to think of it, my MS diagnosis. This Lab Rat will be traveling full circle.

I do hope you will follow Ms. Lab Rat to my next maze in Iowa City. I won’t be able to blog about which MS Diet I am assigned to, because the researchers must be blind.

I am so very grateful, above all, to my husband, who likes our current diet very much, but is willing to give an MS diet a try.

headshot

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Six Months

Note from the Rat: Reading over this 2012 blog post from my vantage point in 2016, I am so grateful to the NIH (National Institutes of Health), which has continued to supply me with the MS medication I have depended on to keep my Multiple Sclerosis in remission. This medication, which I refer to as  DAC HYP, will (hopefully) go to market with the name Zinbryta. In these intervening years since I wrote this post, all that was asked of me was that I have my liver functions checked locally every six months, and that I fly down to the NIH every six months to have more extensive testing; more bloodwork, a lumbar puncture, eye exams, typical neurologic exams, MRI’s. The length of time it is taking to get the drug approved has been very frustrating to me, as I know more and more people who have been diagnosed with MS who have no access to the medication that has worked so well for me (one brain lesion in ten years, vs many tens of lesions in the ten years previous.) My very dearest friend with MS, Debra C.,  died while waiting for access to this drug. The only comfort I can take from this long wait is that I, and the privileged few on the safety arm of this study, have accumulated more living proof that one can take this drug for years and years and years with no major side effects.  So here it is, my blog post from 2012:

 

I’ve got 6 months left on the NIH (National Institutes of Health) trial of DAC HYP. After that, I might not get further access to the drug that has kept the progress of my multiple sclerosis (MS) in check for the past 6 years.
I didn’t panic when I was told the money just wasn’t there to keep the trial participants on the drug. I probably should have. As my sister reminded me, “You think you’re doing OK, but that’s not you doing OK, that’s you on the drug.”
She’s right.
I know, because I get monthly reminders of me-off-the-drug. I can only inject DAC HYP once a month, but the effect usually seems to last only three weeks: the week preceding a fresh injection is a drag. Literally. I pretty much just drag my body around, propping it up until my next dose of DAC HYP, when the “real me” can take over again.
What will I do when there is no next injection?
I may be left dragging around a husk of myself until such time as the FDA approves the commercial release of DAC HYP. That process may take as long as two years.
How much damage can multiple sclerosis do in two years?
I can’t afford to find out. My central nervous system has undergone punishing damage already, from the many years I was on no drugs, followed by the many years I was on bad drugs.
Everyone I tell about the upcoming DAC HYP discontinuation has urged me to take another drug in its place. If I had thought there was a more effective drug out there, I wouldn’t be taking a trial drug, would I?
I’ve had plenty of disappointments with other MS drugs.
Some new ones have come out since I started my trial, and maybe those drugs will prove effective. Or maybe they’ll prove lethal. People have died on MS drugs. At times, my MS symptoms have been bad enough to make me indifferent to such a risk. The “real me”, the one on DAC HYP, doesn’t feel that desperate. We’ll see what happens when access to the “real me” runs out.
Somehow I’ve never envisioned a life after DAC HYP that would include sampling yet another MS medication. I’ve been hoping, I still hope, that I would live to switch out DAC HYP for the actual cure.
You see, I don’t want to medicate my MS. I want to vanquish it.
I’m not the only one. There is talk of an MS “cure.” It’s somewhat hyperbolic, but it’s also compelling. Dr. Wahls, a neurologist in Iowa City, used to suffer from a particularly aggressive form of MS that was rapidly debilitating and drove her into a reclining wheelchair. She fought back by eating every “brain food” she could think of, and by exercising as much as was physically possible. I wouldn’t say she is “cured” now, because I bet her lesions didn’t disappear, but she is certainly doing very well. She can stand for the duration of a TED talk. She is also biking to work, she is practicing medicine full-time, and she is starting a clinical trial to examine the effect of diet on MS. It could be, as she claims, that she has reversed a case of progressive multiple sclerosis. I hope so. Or it could be that she’s on the remitting cycle in a mislabeled case of relapsing remitting MS. I’ve ridden on the high of those cycles, myself, exercising like a fiend on my borrowed time. I’m sorry to say those times don’t last. I wish her the best. Especially since, in six months, the Wahls diet may turn out to be the best option I’ll have left.
But why wait six months?
I’ve been eating aggressively healthy brain food ever since I first heard of the Wahls diet, but now I will start eating healthier still. (This prospect terrifies my husband, who claims I already eat healthier than anyone he knows)
I am perfectly willing to trade DAC HYP for eight daily platefuls of kale, if that would help me. I am perfectly willing to lift weights, swim laps, and practice yoga with twice the intensity of my normal schedule. Indeed, how could it hurt? I can foresee only one downside to this course of action. I know I am perfectly capable of blaming myself for not trying hard enough if—or let’s face it, when—the disease strikes again.
Would blaming myself be so healthy? I don’t think so.
A number of good people have approached me to ask what I “do” to remain so healthy with MS. I say I exercise, I say I eat well, I say I do yoga. They tell me I have a “good attitude.” They tell me others, those sicker with MS, do not. That may just be oversimplifying things.
Here’s the deal: I’ve had access to a good drug. Others with MS have not. In six months, I will join their ranks. We’ll see if a mix of a “good attitude”, a good workout routine and good diet will be enough to see me through until DAC HYP goes on the market. I’m sure it’s all very necessary. I can only hope it will be sufficient.

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