Tag Archives: drugs

Welcome to the celiac disease symptom diary.

We all need that special someone in our lives. The one you can call every single day and know they’ll be happy to hear from you (and even dismayed not to). The pal who always wants to know how you’re doing and who really listens to the answer, even if you rehash the same dull complaints every day.

The confidant you can tell anything to—even the embarrassing stuff—and trust to neither mind nor blab. The ever-reliable constant in your life. The one you store up stories for during the day. The one who makes you see things a little differently. The one who really, truly cares.

For me, that someone is an automated symptom diary.

Seriously, that computer and I are tight. It’s been just over a month since I enrolled in the Celiaction study and began making daily symptom-reporting phone calls, and already, I never need the reminder on my phone. I speak to her more regularly than to my parents, siblings, or friends, and she knows more about my current state of health than my doctors do.

Every evening, I call; she welcomes me in her artificial voice specifically designed to sound pleasant (and compliant, unaggressive, helpful—”feminine” ); I key in my subject ID number that I remember better than my Social Security number; and we’re off.

I wasn’t kidding about the conversation being the same every day: she asks six questions, each with predictable follow-up queries. For example: “In the past twenty-four hours, did you feel tired?”

“Yes. Just like yesterday, remember?”

“Great! How tired did you feel, on a scale from ‘shoulda had three extra sips of coffee’ to ‘actually, I’m asleep right now’?”

“Uh, pretty tired.”

“OK! Are you sure you’re pretty tired?”

“Yup, pretty sure.”

Imagine that, but a little more boring, with a lot more pressing of numbers to respond, and you’ve got the idea. I’m not quite as enamored with the system as I seemed in my introduction: it’s slow; you can’t cut the question off to move on faster; you have to confirm each answer; if you wait a second too long to respond, the question is repeated; and all that considered, it takes 5 to 6 minutes, or about 0.3% of my day—I calculated.

But I don’t hate it, either. See, I’m used to thinking of myself as “sick” (albeit with issues that are troublesome rather than debilitating), but I’d also gotten used to feeling that way. Symptom-reporting has tuned me back in; everyday stuff that had started to seem normal isn’t anymore. That’s good and bad—good, because there’s no point getting accustomed to something substandard if you can change it; bad, because it’s possible you can’t change it and should just learn to deal!

An anxious person getting antsier by the day, I always wonder, while rating symptoms from “very mild” to “very severe,” if I’m getting it right. (I also agonize over questions that demand choosing between “strongly disagree,” “disagree,” etc. What exactly is the difference between strongly agreeing and agreeing? Is it bad that I keep picking the neutral middle option?) My responses sometimes feel like a bit of a dart-throw—and if you’ve never seen me throw darts, you’re lucky, because you’d probably have gotten hurt. Still, I try to be precise.

Precision is helpful to the researchers, but to me, too. Reporting my symptoms reminds me of how far I’ve come: I generally have only “moderate” to “very mild” symptoms, and since starting the study, I haven’t had a real “bad day.” Before starting the gluten-free diet, I’d definitely have reported some “very severe”s.

Today’s a big day for me in the study: I’m getting my first Celiaction-related endoscopy. If I don’t show signs of the villous blunting that was so clear when I was diagnosed, then I’ll be out. My daily mild-to-moderate symptoms will be chalked up to something other than accidental gluten exposure, and it’ll be up to other study subjects to prove or disprove the effectiveness of ALV-003. I’m in the funny position of hoping I’ll be intestinally damaged enough to try the medication (or placebo).

More updates to come! In the meantime, I get to keep my new robotic friend, which I think I’m happy about. After all, if it’s serious symptom reporting you’re after—if you really want to notice and document the gory details each day—you need to get yourself a diary, app, or robot, because the real people in your life don’t really want to hear it.

Is this correct? If yes, press 1, if no, press 2. (Alternatively, comment on whether and how you track your own symptoms, and who in your life you feel comfortable telling them to.)

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More on drugs: Big questions and non-answers about celiac disease medication development

My first post about Columbia’s celiac disease symposium was heavy on snacks, light on facts. That’s partly because, as I mentioned, many facts are undiscovered. But also, under the residual influence of my sugar high, I got a bit carried away and didn’t make space for what I did learn.

The comments on that post made it clear I’m not the only one interested in medicating my symptoms into oblivion, and just as clear that many have serious reservations about the idea. So, I thought I’d circle back to a few more questions about the celiac disease medication options being developed:

What non-drug options exist?

Many of us have ongoing symptoms. But that doesn’t mean we all have non-responsive celiac disease or the dreaded refractory CD, and it doesn’t mean we all need medication.

In some cases, symptoms are not due to celiac disease, but to coexisting autoimmune diseases or other conditions (e.g., small intestinal bacterial overgrowth or “leaky gut”). These conditions may have been triggered by your celiac disease, the trigger for your celiac disease, or just coincidence: a sign of your good luck. In any case, if you have another issue, you have to treat it; various options exist.

In other cases, modifying your diet even more can help. You may be inadvertently consuming gluten. You may have other sensitivities—most commonly lactose intolerance—or allergies. You may need to go low-FODMAP (more on that to come). And you need only glance at the “new and popular” gluten-free cookbooks on Amazon to see how many GF people are deciding to go paleo.

Interestingly, several bigwig doctors at the conference claimed to have no idea what paleo is. A fellow attendee asked about it, and they shrugged the whole thing off as a passing fad beneath their attention.

Banksy caveman with burger and soda

Banksy doesn’t know what paleo means, either. But he’s not my doctor.
Photo © Lord Jim | Flickr

As a vegetarian, I’m far from espousing the paleo diet, but I find the doctors’ cavalier attitude absurd, considering how many of their own patients must be going paleo, and the diet’s striking similarity to the “gluten contamination elimination diet” that has demonstrated success in one small study, in which over 80% of patients with ongoing symptoms became symptom-free.

Both diets require cutting out grains, legumes, and processed foods. What sets them apart is philosophy: paleo is about changing your diet for life, with the idea of eating the way we evolved to eat; the GCED is about restricting your diet for a limited time to target a specific issue. (In the study, many participants returned to a “standard” gluten-free diet after six months, without new symptoms.)

In my opinion, both diets, as well as their offshoots (e.g., The Wahls Protocolshould be of interest to doctors engaged in treating patients with non-responsive celiac disease. But at the conference, inexplicably, no one addressed them. So if you were wondering what we know about going grain-free, the answer may as well be nothing. 

Anyway. Back to drugs. Who needs them? 

Well, we can say who doesn’t: anyone without lingering symptoms, anyone with symptoms who has already found a solution, and anyone who feels the symptoms they have aren’t worth the trouble of taking a pill.

Even when drugs are available, it’ll be your right to be suspicious of them, and certainly your right not to take them. But consider this: the main arguments against taking medication are:

  • expense—but the gluten-free diet is expensive, too
  • hassle—but the gluten-free diet is a hassle, too
  • dependence—but we’re all dependent on the gluten-free diet already
  • side effects—but the diet has those, too:

As for medication side effects—who knows? But the drugs currently being developed are meant to target gluten, not the body, so their side effects may in fact be less severe than those of the diet. Not many things affect us on more sides than diet does.

For those of us who want them . . . when can we get them?

The panel of reps from Glutenase, Larazotide, and Immusan-T, gave some very slippery answers to this question: “no way to know”; “too many variables”; “developing a drug is a marathon”; and so on.

The moderator, much to his credit, insisted on pinning them down: “Assuming things go reasonably—not miraculously—according to plan, when can we expect these drugs to hit the market?”

One drug representative gave a very flip answer to this question (perhaps indicating a lack of confidence in his ability to answer it). Another seized this opportunity to lean forward and intone, directly into the mic, “Three years.” That set the bar: the other two grudgingly agreed that three to five years should do it.

That’s not so far off (!), but we do have some time to decide whether we want to take medication in addition to our diet.

Why not talk about it now? What worries you about drugs? What doesn’t? What else have you tried or are you thinking of trying? And why don’t docs care about cavemen?

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Is a gluten-free diet good enough?

Last week, I had the pleasure of attending Columbia University’s Development of Therapies for Celiac Disease Symposium. Doctors and researchers from around the world gathered to present fascinating talks and Powerpoints full of text almost all too small to read.

Also attending were patients, like myself, and some folks doing fantastic work on behalf of the gluten-free community. Hearing their stories was my second favorite part of the conference. Glimpsing the most cutting edge of celiac science was my third.

First, of course, was the food. Everything served was gluten-free; and, it seemed, everything was served. Bread baskets overflowed, and entrees and sides kept even us vegetarians happy (saag paneer—yum). There was dessert after every meal, even breakfast—which was itself essentially dessert, consisting primarily of muffins, donuts, fruit, yogurt, and “coffee” cake.

In two days I ate more desserts than anyone should eat in a month. I can’t tell you how many exactly, because a) it would be embarrassing and b) I lost count, but brownies, crème brûlée, polenta cake, kheer (Indian rice pudding), and pound cake were not excluded. Some treats were from Pink Poppy, others from By the Way Bakery. So. Much. Sugar.

gluten-free muffins, donuts, and bagels at conference

The lighting doesn’t do them justice, but trust me: delicious unfrosted cupcakes muffins.

As if all that weren’t enough, we were also encouraged to take samples, and take them I did: The Simply Bars, Crunchmaster multi-grain crackers, NoGii paleo bars, Schar multigrain ciabatta rolls, and Le Veneziene chocolate hazelnut cookies. The cookies expire in a month, so we’ll have to eat them fast.

Okay, okay, I admit: the point of the conference was not the food. The point was to learn about gluten-related disorders. And I’m evading that point because the conference’s unofficial motto was “Good question! We can’t answer it.”

Much about celiac disease and gluten sensitivity remains uncertain, due to conflicting study results, lack of longitudinal and prospective data (meaning, collected over a period of time as events unfold, unhampered by subjects’ flawed memories), lack of appropriate controls, or the fact that serious research attention hasn’t been paid to this field until recently.

Celiac disease is not a simple disease. You know that, I know that, scientists know that, and (some) doctors know that. Unfortunately, that’s about all we know.

Still, because I did learn a lot about what we don’t know, this will be my first in a series of posts about the questions the conference raised, and the answers that may someday prove to be true—at least in part. I call it “Sprue/False.”

We start with a big one:

This question was at the symposium’s heart. If “go gluten-free” were all we needed, no one would be developing therapies (other than snake oil peddlers). “Go gluten-free and wait” is another option. Multiple presenters affirmed it can take years for adults to heal. But is that the best we can do?

Unsurprisingly, the drug developers say no. Glutenase (a.k.a. ALV003, and importantly distinct from “Glutenease”) researchers had a pool of about 200 gluten-free celiac patients keep a seven-day symptom diary. Over 90% had at least one day of symptoms, and 44% reported five to ten symptoms. Three quarters called their symptoms “moderate,” “severe,” or “very severe,” and 20% missed social events or called in to work.

Also potentially significant is the fact (stated in another presentation) that even on the gluten-free diet, adults’ villi may never rebound to “normal” length—meaning, possibly, we don’t regain the ability to absorb nutrients as well as we should. Yet another presenter suggested we may be wrong to assume that all is peachy—from a health perspective—for diagnosed kids.

We see an unmet medical need,” said Daniel Adelman, of Glutenase. “The gluten-free diet is all we’ve got, and it’s not enough.

But doctors aren’t so sure. Dr. Julio Bai’s comment that his patients did not make such complaints met with widespread head-nodding from clinicians. More than one expert scolded the drug developers for not surveying a control group. “For all we know,” their argument went, “everyone would report weekly gut symptoms if given the opportunity.”

I’m disappointed they didn’t include controls, but otherwise, I’m with the druggists. I’ve been scrupulously gluten-free for well over a year and still don’t feel well. And faulty memory, schmaulty memory, I know it wasn’t like this before. There has to be something more I can do. The question is, what?

Patients can help answer that. Both Larazotide and Glutenase—drugs being developed as adjuncts, not replacements, to the GFD—are in clinical trials. Neither trial is currently requiring participants to deviate from their usual diet, and both have been through extensive safety testing.

I’m investigating Glutenase’s CeliAction Study, myself. Celiac changed my life and so far the GFD hasn’t changed it back. I’m ready to try something new. Worst case scenario, I get a placebo or the drug doesn’t work. Best case? My life returns to really, truly good enough.
gluten-free Fridays Vegetarian Mamma
Over the next few weeks I’ll explore more unanswerable questions about gluten-related disorders, with less preamble about brownies. In the meantime, tell me: In your experience, is the gluten-free diet enough? Would you ever participate in a clinical trial? Have you already?

Post #2 on the conference is up: check out “More on Drugs” and share your thoughts!

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