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.

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 290 other followers

Advertisements

TRAP (part 2 of Ms. Lab Rat’s Latest NIH adventure)

The vast lobby of Building 10 of the NIH was nearly vacant of the usual international mix of medical professionals and imperiled pilgrims, yet it felt cluttered. This majestic bastion of scientific research had been stuffed with numbered tables bearing garish gingerbread houses, presumably made by the in-patients and staff. It looked like a pop-up church raffle. I glanced past the hapless man marooned at the Welcome Desk and noted that the coffee shop was now barricaded by scaffolding. The scent of coffee had been replaced with insidious notes of powdered white sugar. I wondered if perhaps my system of always accepting the first appointment of a given span of available dates would finally let me down. We were three days out from Christmas. The speculation on the van was that the leading physicians would still be on vacation. I didn’t buy into that. I expected to see leading physicians. Then again, I’d also expected coffee.

I ducked into the area on my right to fill out the paperwork for meal reimbursements. Over the years, the reimbursement office has retained the right to perpetuate various iterations of needlessly awkward exchanges. The first few years I’d gone there, the cashier’s desk was an inch or two too deep for the cashier to actually reach the exchange window to grasp a lab rat’s ID or to pass a lab rat some cash. It added a bit of tension, a bit of comedy, to every exchange. After a few years of these capers, the cashier figured out she could use a pincer device to bridge the troublesome gap. Her victory was short lived. By my next visit, the entire office was moved. By the visit after, the “short-armed” cashier was gone.

The tradition of inventive obstructions was still in full force, I noticed. There was a sign in front of the office that receives reimbursement forms which instructed all form fillers to stand at a certain distance in front of the glass door, and further warned that those who did not stand would not be seen. In other words, Wheelchair Users, Begone.

Furthermore, the very layout of the office was designed to prevent eye contact, even with compliantly standing non-wheelchair users. The L-shaped desk for the sole employee in the office was set back and to the side of the glass door. The computer was placed along a wall at a ninety degree angle from the door, so that the occupant of the office effectively had her back to the door every time she looked at her computer. Once again, the office had been created to make it structurally impossible for the employee to do her job effectively.

I wish I could say this office is an anomaly in the NIH. It is not. There are doors in the MS clinic without wheelchair accommodation. If that’s the NIH plan to stop MS progression…it isn’t working yet.

The only other pilgrim there was a man sprawled out on a chair. Had he been conscious, I would have asked him if he needed me to signal to the functionary behind the glass door. Instead, I waited for the functionary to complete her personal phone call, then check her computer screen, then finally swivel somewhat to notice me standing the appropriate distance from the glass door, like a good wheelchair-free pilgrim.

She waved me in.

I used to feel unworthy of meal reimbursements. But that was before the drug the NIH tested on me came out on the market, and my monthly deliveries came with an invoice of seven thousand four hundred and something dollars per month.

I handed in my clipboard, feeling entitled to every last penny, darn it, and headed for my appointment at Phlebotomy.

The acronym for this new study? TRAP.

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 290 other followers

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?

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 290 other followers