The Failure of Wellness – Part 2

Last week I completed my last clinical visit for the trial. Maybe to prolong the experience, I lost my way in the office complex. For some reason I was sure the building was on the right, when, in fact, it was and remains on the left. How did I misremember that? I kept driving around and around the buildings on the right, believing number eight would pop up between numbers twelve and sixteen. It didn’t. I finally decided to drive to the other side of the complex and there, eight appeared suddenly between seven and nine. Imagine that!

Once inside the correct office, I was whisked into the exam room, which still registered as near-Arctic on the thermostat. Once again this proved problematic for drawing blood, though the coordinator only stuck me twice before hitting the vein. My blood trickled into the test tubes, seemingly unimpressed with the coordinator’s sense of urgency and clearly miffed by the ambient temperature.

The physical exam, if one could call it that, lasted about as long as the blood draw. I wondered if the doctor thought celiac disease was contagious because her hands barely palpated–felt for the organs in–my gut. I suppose the lack of pressure was a gift, as it always hurts when someone pushes on my abdomen. She also listened to my gut through her stethoscope: the raucous gurgling might have sounded musical because she listened quite attentively.  She asked how I felt and if anything was bothering me. I said I felt fine and nothing bothered me except not being able to continue with the trial. She smiled and said they were bothered by that, too.

After providing the requisite sample cup of liquid I was ready for discharge. The coordinator handed me my participant incentives (gift cards) and asked if I had any questions.

I asked if they were having trouble getting all the research subjects they needed and she said they were. The sponsor hoped to have everyone enrolled by September and now, in October, they aren’t anywhere near the number they need. She said this was for two reasons:

1) People were diagnosed with celiac disease using a DNA test (very controversial and not recognized as reliable by gastroenterologists), a naturopath or holistic health practitioner assessment and diagnosis, or other process that did not include an intestinal endoscopy with biopsy. These people don’t make it past the initial screening visit and are not eligible to participate at all.

2) The stringent measures of existing intestinal damage: the amount of damage that has to be present is so high, people like me who have been on the gluten free diet for more than a year don’t meet it. She said there have been thousands of people like me who got as far as I got, only to fail randomization. That’s expensive (see my post: Being Part of the Cost Calculation for New Drugs).

I also asked if they would keep my records on file and contact me if the research protocol changed or if they had new studies related to celiac disease. She said yes. She then asked if I was interested in other studies and I identified the health issues of interest to me.

So now I’m in the equivalent of eHarmony for research trials and lab rats. They’ll match me along several dimensions of compatibility with the studies best suited for me, and vice versa. I feel good about this. Somewhere out there is a research trial for which I’m perfectly suited.  Until they find it, or it finds me, I’ll keep eating gluten free and living healthy.

Stay tuned for part 3 of the post-test review.