As we start to see more and more drugs to help with celiac disease, the question starts to become what makes a good drug trial. I have a gluten free diet that isn’t ideal, but effective to help with my celiac. So, the drug companies have to make a good argument to me that their drug will help alleviate symptoms and prevent damage to my intestines in order for me to spend my hard earned money on their solution. This begs the question – can someone prove to me that their drug works without a gluten challenge?
A gluten challenge involves the participant consuming gluten and then being monitored for reaction. In the Nexvax trial, I thought they did the gluten challenges in a clever way. After you had been taking the study drug or placebo for close to 12 weeks, they initiated a series of three food challenges once every two weeks. We were still taking the study drug every 3-4 days so the drug was still in our systems. In the three challenges, one was going to be gluten and one was going to be placebo. The third was going to be whatever they decided either gluten or placebo. So it was possible to get gluten twice during the course of the study. I thought this was about the only way to test to see if someone had a reaction to the gluten and get an honest reaction.
But here’s the trick, the most insulting part of the trial was the very first gluten challenge. We were given gluten to determine if we had a “severe” enough reaction. I kind of think of this as a baseline for our gluten reaction. We all needed to have this information so that when the other food challenges came along we would know if the gluten reaction was the same or different. Was it less severe on the drug than our initial reaction?
Now, I know many, many people will celiac will not participate in clinical trials because of these food/gluten challenges. This is where it gets hard because science can’t move forward without volunteers willing to try the drug and perform the gluten challenges. Some people get too sick or just can’t commit to taking the time off. I get it. At the same time, I think people don’t truly understand their gluten reactions. I know before I did these gluten challenges I thought my reactions were completely different than what they actually were. It was an eye-opening experience to have these gluten challenges. I think if more people participated in gluten challenges they would realize the level of gluten needed to cause a reaction can be pretty high.
The other part of this is that in the Nexvax trial, the amount of gluten consumed was the equivalent of two to three slices of bread. That’s a lot of gluten. Could scientists get the same reaction with less gluten? Would it make a difference in the level of participation in the studies? Would we believe the results if they used less gluten?
Here’s the other thing, in other drug studies like those for cancer, they are never doing harm or putting people at risk of being sick. It is normally this person is sick, give the drug, and are they less sick after the drug. That is normally the way studies go, but celiac is different. That is what makes this so hard to figure out.
As you can tell, I’ve been thinking about this a lot and I really don’t have a solution. In a clinical trial, I would need to see the gluten challenge and biopsy results both before and after to really believe in whatever drug was being touted. Without the gluten challenge, did the drug work or not?
The next question is – if they provided “comfort” measures after your reaction, would it be acceptable? For example, if you knew you threw up after consuming gluten, would them giving you IV fluids and zofran after help? If you were fatigued, would a B12 shot help? Would these measures induce someone to participate? And would this skew the results?
This is the stuff that rattles around in my head late at night and the paragraph below.
As a side note, if you drink wine and eat a gluten pizza and wake up with body aches and a headache and haven’t been diagnosed with celiac disease. It is more that likely that you are hungover from the wine causing the problems rather than the consumption of the pizza. If you ate the pizza alone, then maybe, but come on.
So, the real question is, would participation in clinical increase if there was no gluten challenge? That is my question.