I got an update from Nurse Ratchet today. 246 people have been screened to be in the trial. Only eighty-four have been randomized and are getting medicine or placebo. Only 35% of the people that believe that they meet the criteria for the study are eligible and that has been consistent with all of the previous updates. The low number of people qualified makes me question a few things. Let’s have a chat about those.
Before your initial appointment for Nexvax screening, you have to provide your blood work results and biopsy results from diagnosis. I’ve been diagnosed for 7 years and have changed doctors several times. I’m not sure I would be able to return to my original doctor to get my original blood test results even if I wanted to because he retired. But I have a big folder that I put print outs of test results and keep all test results so that I can pull out the information if I ever need it. As a matter of fact, the Nexvax doctor looked at some of my blood results and said he was surprised they did a biopsy for me. My blood results at that time, almost a year after diagnosis, were almost normal. I showed him my blood tests from my original diagnosis and he went, “ah, now I see.” My point is, we should always keep a copy of our own medical records because you never know when you might need them. Also, nobody can question your diagnosis if you have all of the original paperwork.
Second, people could fail the gluten challenge. The gluten challenge is a miserable test. On gluten challenge day, you arrive at the testing center. They take blood work, urine test, weight, blood pressure, and then EKG to make sure your heart is ok. Then you have 10 minutes to drink a gluten drink containing 10g of gluten. The drink tastes like uncooked flour – yuck! Then we wait. You wait to see what happens and if your reaction if violent enough. Vomiting and diarrhea are good in this case. I cannot imagine what else could happen, but some sort of violent reaction is what they are looking for. Once that is confirmed, you are in.
As a side note, the first person that came through my testing center, failed the gluten challenge. He did not have a violent enough reaction. So, you can fail to qualify at that phase.
Finally, are people getting a good diagnosis? I know this is controversial and I’m not sure why. To get a medically sound diagnosis of Celiac disease you have positive blood work (any positive Celiac test will do) and endoscopic biopsy demonstrating damaged villi. If you have dermatitis herpitiformis, all you need is a positive skin biopsy – but Nexvax is not targeting those patients. You can have all the symptoms in the world, but without those two things, the diagnosis is incomplete.
Taking the full diagnosis theory a step further, as the flurry of drugs start to become available for celiac disease, will someone without a complete diagnosis be able to get the drugs? I’m sure people will get the drugs, but will they be effective? What if someone was misdiagnosed? I’m not a doctor. Diagnosis is something for you and your doctor to decide and I don’t need to be in the middle of that. I’m just suggesting that a full diagnosis is a good, non-gray area to be.
So, if you have all of these things and live close to a testing center, please consider joining the study.