CeliAction Study

I've been mulling this one over for a while. Even as I write this, I'm not entirely sure where to start. I guess I'll start with the basics. Alvine Pharmaceuticals, Inc is sponsoring a study on an investigational drug for Celiac Disease. If you'd like to read more directly from the company, you can go to the company website here.

I'll admit I haven't done a large amount of research on this study, but I guess my intent is to give my opinion on studies in general, so I'd prefer to not know too many specifics.

Years ago, I was a member of an online forum when a member posted a question for each of us to vote as to whether or not we would ever consume gluten again if we were "cured." I had been diagnosed about a year or two prior, and I was still flying high on how much better I felt. I think I responded that I wouldn't change a thing--the gluten-free diet was a far superior way to live even if I could take a pill to be cured. A few hours later, I second guessed my answer and decided it would be nice to be able to go out to eat without being a pain to the wait staff with all my questions.

Fast forward to present day, and I'm not sure what I would do if I were offered a pharmaceutical cure. I'm not entirely sure how much I would trust that something would work. My biggest fear is relying on a pill that claimed to prevent any damage, but finding out later that it was simply preventing any symptoms of consuming gluten but the damage was still being done. I've already dealt with colon polyps, and I have a huge fear of getting cancer.

I always questioned when a drug would be introduced. Many individuals believe celiac disease hasn't received the necessary attention from medical professionals because the treatment is "natural." There is no profit in diagnosing celiac disease because there is pill to prescribe. There are no pharmaceutical reps sending kickbacks to the doctors, therefore there is no incentive to know anything about it.

So what is the purpose of this study? This is what the website says:

The CeliAction Study is a clinical research study evaluating an investigational medication for celiac disease. The study will explore whether the study medication is able to improve the damage in the lining of the intestine caused by even the smallest traces of gluten.

The study will also evaluate whether the investigational medication improves any symptoms of celiac disease compared to a placebo. While enrolled in the study, you will be asked to maintain the gluten-free diet you are currently on.

In the interest of full disclosure, I question A LOT about this study. These are my own personal thoughts on the matter:

• It seems to me that this study will require a HUGE time commitment from the participants in order to truly determine if the medication is working. 
• I question how they will determine if the medication is working if the individuals are supposed to continue on a gluten-free diet. No gluten=no damage=no study. 
• I question if participants will take unnecessary risks. I saw a claim from someone who was supposedly part of the study stating that she had traveled out of the country and because she was having such good luck with eating out and not getting sick, she decided to try eating an entire croissant. She claims she didn't get sick. The pill isn't meant for the actual consumption of gluten, but how many people will risk it anyway?

How could something like this benefit those with celiac disease? My thought is that by introducing a medication, pharmaceutical companies will give doctors an incentive to diagnose it. At this point, such a small percentage of individuals with celiac disease are diagnosed that it is absolutely ridiculous. The more individuals diagnosed, the more food options there will be (hopefully this would also help to eliminate the "fad" part of the gluten-free diet).

I hear more and more about this study every day. I've even seen a commercial on network television. I'm hoping with all of the exposure, they are able to obtain a large enough group of participants to determine the safety of this pill.

In a perfect world, I believe doctors would be better educated on celiac disease, and they could give better advice to their patients. Most doctors have no idea what to tell their patients who are diagnosed and simply refer them to the internet. Is this pill necessary because people aren't responding to the diet or because they're not following the diet correctly?