Saturday, June 23, 2012

Brief FAHF-2 Update

A couple of you have asked about the progress with my son's FAHF-2 clinical trial. I haven't written about it because there just isn't a lot to write!

The pills smell like a combination of chocolate
and tobacco. They come in HUGE bottles that
get refilled each time we go back.
He started the meds after our challenge testing in mid-April. We've been back for a six week check-up that was uneventful. Other than that, the biggest challenge is simply getting him to remember to take the meds and take them fairly consistently. They're supposed to be done at the same time each day.

Any of you who have teen-age children can understand how difficult the "same time" requirement is, since waking time on a school or activity day might be 6:30, and waking time on a NON school or activity day is more like...1:00 in the afternoon. So, we've stretched the rules a bit (with their knowledge) and just ensured that he eats three times and takes the meds three times, at least 4 hours apart. Apparently this is an issue with just about all the trial participants... except the lone girl, who I'm sure is organized, prompt and responsible.

I've seen on my blog stats several searches for "how can I get FAHF-2." The answer is: you can't, at least not through Western medicine. I think they are hand-making these for the trial participants. They did mention that they've reformulated the drug now so future participants will not need to take as many pills, which is excellent. This would not work long-term for anyone. The constant reminders are a major source of stress in our house.

I have had trouble impressing on my son that this is a bit like Willy Wonka's Chocolate Tour. If you break the rules, you're out, and the prize is possibly all at the end. If he's taking placebo, we want to make sure we follow the rules and stay in so we can get the real drug! No missing doses!


They still need two participants in the Chicago trial before they can "close it out." What that means to us is that, until everyone finishes the trial, NO ONE finds out who was taking placebo. And, if we do have placebo, we will not get the real drug until everyone completes.

Of course, there's one other way we could find out: by a difference in the challenge test dose tolerance.

In September, we'll go back and do the whole testing rigamarole over again. Ten days off the antihistamines, followed by two food challenges at least three days apart. I know my son is dreading it. (Not the challenges! the being off antihistamines!) If he gets to Dose 6 again, then either we had placebo or the medicine just didn't work. If he DOES get further, they will continue the medicine another two months, into November, and we'll go through yet a THIRD round of challenges in the hope he'll get even further. 

The first couple of weeks he was taking the meds, he was very sniffly and congested. Not a cold...no coughing...just an odd throat clearing and nasal congestion. Was it related? The trial coordinator just said "hmm". She did say none of the other kids were reporting that as a symptom, and that the "symptoms" seemed to be all over the board. Of course, everyone is looking for symptoms, so it's possible nothing is truly related to the medication, even for the kids taking the real McCoy.

If you are at all interested in participating in the Chicago trial, PLEASE contact them! We really want to see it get closed out so we can find out at the end what all the work was for. Also, they mentioned at the last visit that they will be adding a trial shortly for the peanut patch that will include component testing for all participants. The peanut patch trial will take kids 6 and older and is part of a network of trials throughout the US. (This patch has already been tested extensively in Europe with very good results - about the same levels of tolerance as the oral allergy trials.) Later in the year, they'll be looking for participants for a wheat protein trial.

Yes, it means a food challenge...but who knows? You might actually get good news from that challenge. After all, we heard through the grapevine that two of the kids tested for the FAHF-2 trial passed the initial challenge. (Wasserman's assessment at AAAAI this year was that 30% of kids in the initial OIT trials did not really have a peanut allergy...so it's obvious why they've added challenges to most subsequent trials.)

If you have an older child and are starting to think about the dangers from almost-inevitable exposures, I hope you'll consider getting involved. The risk calculation changes a lot as they age. That 5-peanut buffer that didn't seem like such a big deal when they were little and we could control all their food becomes much more important as they morph into risk-taking semi-adults. More than three quarters of the kids in the OIT studies showed an improvement in quality of life measurements. That alone makes a trial worth considering!


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