Tag Archives: drug development

Symptomatic celiac disease driving you crazy? Then try CeliAction with me!

“The definition of insanity is doing the same thing over and over and expecting different results.” A whole bunch of dubiously wise people have told me that. The quote’s attributed to every famous smart person ever, usually Albert Einstein, and it has a certain ring of truth. So I hope you won’t blame me for wondering . . .

Am I insane?

If Albert Einstein said it, it must be true.

If this guy said it, it must be true. (Psst: he didn’t.)

I’ve been dutifully eating gluten-free for nearly a year and a half. But despite saying no to wheat, rye, barley, and even oats over and over again, I’ve seen so little improvement in my health that celiac disease is starting to seem like a sick joke. I can’t help but wonder: Are all those people who claim to recover just punking me? Are you? Is it crazy to continue a rigid, socially hobbling diet without any signs that it’s working?

Luckily, when these questions were threatening to make me really insane, I found a great Psychology Today article dismantling this “definition of insanity.” Ryan Howes argues that many use the cliche as an excuse to avoid the long-term, difficult, and sometimes thankless work of self-improvement. They confuse perseverance—a “strong, valuable quality”—with perseveration, a particular psychological issue. Howes writes:

Repeating the same constructive behavior over and over, hoping (one day) for a positive result is difficult but virtuous. . . .

Perseveration feels compulsive, hopeless, helpless, automatic and unsatisfying. There is a desire to stop, but stopping doesn’t feel like an option. Perseverance feels like striving toward a noble goal, and whether or not it’s reached . . . there is virtue in the effort.

Now, I can’t say that avoiding gluten never feels compulsive, hopeless, helpless, automatic, or unsatisfying. But usually, I feel I’m doing something constructive in hopes of (eventual) better health. The day-to-day results may be nil, but I won’t be giving up my diet anytime soon.

On the other hand, just as it’s not crazy to keep striving in the same way for a noble goal like health, it’s also not crazy to try something new. If you aren’t seeing as much progress as you’d like, it’s a good, sane idea to take extra steps that might help you reach your goal and keep you from going nuts along the way.

That’s why I’m excited to report that I have enrolled in the CeliAction Study!

The CeliAction Study is testing ALV003, a medication intended to break gluten into pieces too small for the immune system to recognize. Even careful people like you and I probably get trace contamination; this drug may keep our immune systems from punishing us for it. It’s worked in a test tube, and only science will tell whether it works in humans.

Now, I don’t believe in medicating problems that have effective, simple, non-pharmaceutical solutions. But I do believe in medicating everything else. If the gluten-free diet were good enough for everybody, I’d be shaking my head at those money-grubbing drug companies with the judgiest of ’em. But for many, it isn’t. I believe that developing new therapies for celiac disease is a necessary cause, and I look forward to supporting it. If you’re interested, I invite you to join me!

You can enroll if you have celiac disease, have been gluten-free for a year, still have symptoms, and are close enough to one of the many study locations (see contact info for the Columbia location here). You’ll continue on your gluten-free diet and do a few other things over the course of 28 weeks:

  • Get bloodwork and endoscopies done toward the beginning and end (fo’ free)
  • Call a special system every night to report on your symptoms (then drift off to sweet dreams about satisfying bowel movements)
  • Stir the powdered medication into a beverage and drink it at each meal
  • Not get pregnant
Only 30% of participants get the placebo, so odds are OK you'll be stirring the real thing into your water glass. (Photo © Dennis Skley | Flickr)

Only 30% of participants get the placebo, so odds are OK you’ll be drinking the real thing. (Photo © Dennis Skley | Flickr)

Like another infamous study, it’s placebo controlled (and double blind), so you won’t necessarily get the drug, and either way you won’t know. You also have to show ongoing intestinal damage in the first endoscopy to be given the drug or placebo. But IF you get the drug, and IF it works, THEN your quality of life might improve.

If those ifs don’t work out, at least you get to be one small cog rolling forward the machine that is scientific progress. Plus you get paid (cha-ching!), and if you’re loving the drug at the end, you get to keep taking it for a while. (Unclear whether that holds if you’re on the placebo. But hey, if the placebo works I’ll take it.)

It’s quite possible I’ll hate the phone calls by the end of the study, and maybe I still won’t feel better. Maybe I’ll feel crazy for having gotten myself into this.

But mostly, I hope, I’ll be happy that I’m persevering toward my noble goal of better health. And if you’re still striving for it yourself, I’ll appreciate the company. Us crazy people gotta stick together.

Does managing a special diet ever make you feel a bit insane? What new things have you tried in pursuit of health? Are you considering the CeliAction study?

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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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