I think about tomatoes. I think about the first person that tried tomatoes. We look at tomatoes today and see a red or green or yellow fruit that is soft and tastes delicious. However, who was the first person that tried a tomato. In a world that is brown, this red juicy fruit had to look dangerous. But someone had to try it and it has been a significant part of our diet ever since.
I kind of feel the same way with clinical trials. There are many clinical trials that are available for celiac disease in various stages. Without the brave participants that are willing to put their time, money, and effort on the line to participate, the quest for a drug to hopefully cure this disease is not possible.
The Celiac Disease Foundation just published a really good list of the reasons people, especially those with celiac, do not participate in clinical trials. In my opinion they didn’t go far enough, so I’m going to elaborate on their list and my take on the whole thing as someone that did participate. Here’s their list and their reasoning. Here’s my my aggressive advocacy for doing a trial. 😉
I don’t want to be exposed to gluten– I get it. Nobody wants to go through that. Heck, when I did gluten challenges in my clinical trial it was gut wrenching. The mental thoughts of poisoning myself were torturous. The blinded gluten challenges were even worse, because I didn’t know if I was going to be sick or not.
The reality is that I did get sick. One time I was sick for over a week due to a gluten challenge and it sucked. I’m not gonna sugar coat it.
But there are some pro’s to the gluten challenge.
First, you will always and forever know your reaction to gluten. There will be no more guessing if you got glutened or not. You will know forever and ever what your reaction is and this is valuable information. your reaction to gluten may be totally different than what you thought it was. I thought I was getting glutened regularly due to ongoing daily diarrhea. After the trial, I realized that I wasn’t getting glutened anywhere because I vomit and get constipated when glutened. Completely different than what I thought. I had a gastrointestinal infection that was causing the diarrhea and not celiac related symptoms. I now know without too much thinking and can nail down exactly what happened.
Second, unless someone eats whole, unprocessed foods, they are probably getting gluten on a regular basis. Maybe not enough to cause a reaction, but it is always there. Now, at least you will know you’ve gotten gluten and how to manage.
Well, the first was really the biggest pro, everything else was awful about gluten challenges.
I don’t think participating in a study would fit into my schedule – Yep, it is a time commitment. Normally the study sites are open late or early to accommodate their working patients. They know and understand how they need to work with their patients. Talk to the location when considering participating and find a way to make it work.
I’m nervous about trying an investigational drug . Yep, this is scary. When I was in the Nexvax trial the drug was supposed to manipulate the immune system. Now, if the drug worked, great. But what if there were long term effects that were unknown at the time I’m taking this drug. This could be really, really bad for my long term health. We just didn’t know.
At the same time, inadvertent gluten exposure is ruining my life. My system is already being damaged from the inability to do a 100% gluten free life all the time. So, maybe not having to think about gluten all the time could help me and I can potentially improve my health.
The article talks about additional investigational clinical trials that do not involve a drug. Those are good to look at too! It increases the knowledge of this disease.
I’m not interested in a treatment other than the gluten-free diet. Ok. Then do a non-drug trial and help move understanding of this disease forward.
Also, I will say, during my trial I got the best healthcare ever. I had 2 doctors and a whole team of scientists looking at me. Every test I took, every sneeze, every time my cheeks flushed, and especially when I had an allergic reaction and had to go to the emergency room. I had a team of doctors monitoring my care and making sure I was okay.
In the end, I received all of the blood tests that were able to show trends in my health that needed to be addressed and monitored. I didn’t get the endoscopy pathology report, which I really want, but I did get everything else!
I don’t live near a major hospital. Not all trials take place at a major hospital. Look for one near you. If you can’t find any, then that’s okay, at least you looked. See down further about where to look!
I’m worried I won’t be able to change my mind about participating after I’ve already started the trial or study. You can quit at any time. If you don’t like anything about the trial, you can stop. You are a volunteer. They don’t own you. Quit, its okay. At least you tried and found out it wasn’t for you. No problem. You will not be shamed in the public square and nobody will know. Just explain why and it will be okay.
I’m not sure what will be done with my blood samples and medical information They tell you in the informed consent what they will do with the samples. Each trial is different. For the most part, you are given a “participant number” or some other identifier that is unrelated to your name. They will use the information during the trial and then destroy it after a certain period of time. I’ve not heard of an episode of trial data being exposed. Also, because the trial is not run through your insurance, your health or life insurance company cannot obtain the data unless you give it to them.
Clinical trials and studies do not seem safe. I don’t want to gamble with my health and risk a bad outcome. Yep. Its an investigational drug for a reason. Celiac drugs are going to be for the most part a new drug or new class of drugs. nobody has found a way to cure an autoimmune disease. They can treat the symptoms but not the disease.
The first cure for an autoimmine disease makes it even more scary. I cannot make that scary go away. Find a drug that you believe in the way it works and review the safety information. Talk to your doctor about the potential side effects and potential downsides. Talk to your family. Read everything you can about the drug. Talk to the trial people. This is not a decision to be undertaken lightly. Make an informed decision for you and your health.
Phen-phen comes to mind as a drug that was approved but became a disaster. Two old drugs for weight loss. Clinical trials went great and people lost weight. Once it was on the market, people died due to damage to the heart. Drugs pass clinical trials and cause damage after they’ve been released too. So, just because something is FDA approved doesn’t mean its safe either.
I can’t think of any reason I would want to participate Here’s the reason. The next time you get invited to someone’s house or out to dinner think about how nice it would be to just go. To not have to ask a million questions, bring your own food, eat before you go, answer a million questions about the unpleasant side effects from eating gluten, and that is your reason. If that isn’t good enough, think about the next generation of celiac children. Wouldn’t it be nice if they didn’t have to go through what we’ve been through with this disease.
I don’t know where to find current clinical trial or study opportunities. Clinicaltrials.gov is where to go or send me a DM with where you live and I will help.
I get it. Putting your health and time on the line for a drug that may or may not work is very, very scary. Not knowing the outcome and potentially hurting yourself with ingesting gluten. Not knowing if you are getting drug or placebo. Not knowing if this is going to do long term damage. These are big, scary hurdles to overcome.
But, on the flip side, for the ones that are ready, willing, and able to put their bodies on the line there is eternal glory. In ten or fifteen years when we have a real cure, we should thank the brave souls that believed enough in the drug to participate in a clinical trial – whether interventional (with drugs) or observational (without drugs).
If 1% of the US population has celiac disease, that is approximately 3.5 million people. Of the 3.5 million people approximately half of them are diagnosed with celiac. So, that leaves 1.75 million people to participate in clinical trials. Many of those may not be able to because they aren’t close to someplace doing the trial, they have other disqualifying diseases, or they haven’t been diagnosed long enough. Please, please, please consider volutneering to participate if you can.
Also, this is another good time to mention that many of these trials will only accept patients with blood test and biopsy confirmed celiac. So, keep hard or electronic copies of all of the diagnostic paperwork so that you have it and nobody can question your diagnosis. It’s just another reason to get the full testing during the diagnostic process.
Let’s make sure we get this disease figured out and a drug for those that want it!