Thursday, March 21, 2013

There's a Food Allergy Cure! Well, No, Maybe Not...

Haven't we all been here before?

There's a new professional cat fight in the food-allergy community this week, this one sparked by the New York Times story "Can A Radical New Treatment Save Children With Severe Allergies?"  (The NYT has a weird paywall thing going on where you only get to read so many stories a month, so hopefully the link will work for you.)

The therapy is new in that Dr. Nadeau has taken OIT therapy to the obvious next step and addressed all of a child's allergens at once, rather than the one-at-a-time approach that's not very helpful for those of us with MFA kids. Beyond that..not so much is new.

To give a little history, Dr. Nadeau first hit super-stardom at the 2011 AAAAI conference, where she presented a study of 11 milk-allergic kids who had been desensitized in a single day using Xolair®, a drug I just talked about in my Lord of the Rings manifesto that just about no one slogged through. To recap for all you readers who just hate fantasy, Xolair® inserts itself into the receptors in mast cells so IgE can't bind. It's like throwing a bucket of water on the overactive immune response. It also can cause cancer in some people...and anaphylaxis in a not a drug for the faint-hearted.

As I noted in a post earlier this month during this year's AAAAI conference, the glow has faded from the OIT bloom. Here's how one conference follow-up  summarized the long-term outcome for milk OIT:

Only 25% could consume milk without symptoms at 3 months. More than half of the follow-up participants reported frequent symptoms accompanying milk consumption including six systemic reactions and two reactions requiring epinephrine. One participant, who was not symptomatic after passing a 16-gram challenge during the study, became reactive at follow-up and presently only consumes minimal milk.

"We're really worried that the [participants] will leave the study with a false sense of security," Wood said, adding that he'd seen participants lose protection in as early as 1 week off therapy. "Compounded with the fact that these kids don't like the foods they've been allergic to, there's a real inherent risk we need to recognize, and that risk actually scares me a lot more than the recognizable short-term risk" which patients face with monitored dose-escalation, he said. Wood noted that oral immunotherapy "is not yet ready for clinical practice," and that more research is needed with longer follow-up.
There's no reason (yet!) to think the addition of Xolair® to this process will change the outcome. So...just as the New York Times is hitting the street with a sensational headline, the long-term outcome for this therapy has never been more in doubt. 

I still remember the last time the media grabbed the "food allergy cure" headline and ran with it: after the OIT trials first started in North Carolina. Not a week went by for several months without someone coming up to me with a printout showing that "they had cured food allergies" if I presumably would just get on my giddy-up and check it out. My brother sent me the link. Our neighbor. A co-worker. God love them for remembering my child has a food allergy, and for caring enough to send me the information...but it was almost felt like blame that we just were not trying hard enough to cure him.

Another doctor, Wayne Shreffler from Mass. General, has obviously been here before as well. He issued a letter addressing his concerns about the NYT feature.

And then it got weird. The author of the NYT article, Melanie Thernstrom, rebutted Dr. Shreffler's rebuttal.

Can we hope for a rebuttal of a rebuttal of a rebuttal next? Meow!

But seriously...I see both sides of this thing. I am so tired of hearing about the magical cure that's just around the corner, especially when I've been on the yo-yo of hope with this therapy for several year. We KNOW some kids will outgrow their allergy if they're force-fed their allergen. But we're also finding out that it doesn't work at ALL for other kids, and for a third group, it works at first and then fails...sometimes dismally. One in three odds (or thereabouts) is not really a cure, especially if the 1/3rd of kids it works on would have outgrown their allergies anyway. If this therapy only targets the outgrowers, then it's not really a therapy at all -- just a shortcut.

On the other in three. Why not? I can see where parents would throw the dice, in the hope their kid would be one of the lucky ones. If you are that dice-throwing parent, there are going to be a series of new clinical trials opening up around the country that utilize Xolair® as part of the OIT process.

My son and I actually discussed whether he wanted to participate in this trial because Chicago will be one of the sites. However, we all have clinical trial exhaustion at this point. We also picked FAHF-2 for a reason: because it had great potential for positive outcome without the "rebound allergy" that seems to be happening with kids in some of these other trials.

I don't like to be a Nervous Nelly. But, before I would sign up for this trial, I'd want an honest answer from the researchers involved as to why they think Xolair® plus oral immunotherapy has the potential to succeed where just plain oral immunotherapy has not. Haven't we been here before?

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