Friday, October 12, 2012
Halfway There...But The Second Half Is All Uphill
This is going to be a very quick update because the challenge was completely uneventful. My son had a full work-up in the morning, including cardiac, spirometry and many, many Vacutainer® tubes of blood. I asked if they could share anything about RAST levels, since we've had a blood draw every 6 weeks, but this info is apparently being consolidated at Mt. Sinai and will only be shared after the study completes.
After the work-up, he started on the applesauce. (If you haven't read about the FAHF-2 clinical trial before, here's a link that describes the process in excruciating detail.) By Dose 6 or 7, we were all chatting, reading, working...it was obvious nothing was going to be happening. Placebo.
Early on in the morning, I had asked our study manager what type of results they had seen to date. She said that, of the three kids who had completed the second set of challenges, two were able to achieve a four-fold increase in tolerance. (The third probably had placebo, since it's a 2-to-1 ratio of real medication to placebo in the study.)
She also confirmed that I was close on my estimation of the peanut my son had tolerated at the last set of challenges — 490 mg in all, about 1-1/2 to 1-3/4 peanuts. I asked if that was typical for the study and she said he actually reacted sooner than most of the kids — for many of the kids, it took slightly more to set off the reaction. However, my son was a "slow reactor" according to the clinicians, so the time between his doses was increased to half an hour during the first challenges to help ensure he didn't suddenly reach a critical point and have a really bad reaction. Two of the other kids did have bad reactions and her theory was that it may have been related to the dose hitting them all at once.
Here's the bad news: my son's skin tests are actually more reactive now than they were when we started the trial. Does this matter? The trial director shrugged it off, saying that skin tests are notoriously unreliable to start with. However, it made us nervous. Over the last month or so, my son has also noticed a reduced tolerance to "may contain" milk foods that he had previously been eating (with doctor approval) without problem.
It's also possible the medicine needs more time to kick in. (And, if we want to be irrationally hopeful, it's possible the applesauce he had yesterday was not placebo and that he's cured. Sure.)
I guess we'll know more after next week. Even if you disagree with me, please think good thoughts for him. He's just a kid and a very courageous one.