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 few...so 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.
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!
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 hand...one 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?
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?
Seems there is similar in/out-of-favor situation for "cures" as there is for "causes" (as to blame) for LTFA.
ReplyDeleteI'm just so darned glad to no longer be blaming myself and my diet and my breastmilk and the cosmos and, and, and . . .
What's your guess as to how much $$money$$ needs to be poured on studies as to cause and treatment and cure?
Thank you for continuing to blog. Your voice is necessary.
For the record, I totally read your whole Lord of the Rings manifesto, though like other readers, perhaps, I just didn't really have much to say about it. Anyway, I so hear ya on the "FA Cure!" headline fatigue. Can't tell you how many folk sent me the NYT article about Dr. Nadeau's work. I expected as much, and was ready with my calm response that went something like this (executive summary version): "Yes, it's awesome that this research is being done, and Dr. Nadeau is indeed wonderful -- I actually went to school with her -- but OIT is a therapy, not a cure, and the jury is really out about how long-lasting the effects are. No, my daughter won't be doing this, because we don't live anywhere near any of the trial centers and can't afford to move for this." But . . . seriously . . . all qualifiers aside, it is pretty cool to see such an intelligent FA piece (that -- *gasp* -- questioned the mainstream media's darling causation theory, the hygiene hypothesis!!) in such a high-profile outlet as the NYT. Even though OIT isn't a miracle cure, I am glad that this research is going on, and wish the researches, subjects, and families a safe and worthwhile journey.
ReplyDeleteI, too, am glad the research is going on! I know my column sounded a little negative, but I do think it's important to pursue this. It is completely possible that Xolair will be the missing link and magically get kids over the awkward sudden-reaction hump. I just don't see the mechanism for why it would work if OIT alone doesn't...but then I'm not a world-class researcher.
ReplyDeleteAnd thank you for reading the LOTR saga. I've tried to write that post several times now and finally just threw in the towel and put it up as it was. It's almost as long as the movies. :)
As a parent of a child who has completed the multi-allergy OIT with Xolair trial under Dr. Nadeau's supervision, I can say that Dr. Nadeau is very open and candid about Xolair. She also conducts multi-OIT without Xolair. Both of these studies are Phase 1 clinical studies...and she never claims that they are a cure. With regard to the so-called "cat fight," I don't see Dr. Nadeau entering into any fight. The article is being attacked. I think Melanie Thernstrom has every right as a journalist to defend her work against alleged "distortions." I personally found Dr. Shreffler's letter to be unprofessional, inaccurate, and unsympathetic to the real anxiety faced by FA families. In the end...we may not have a cure yet, but we have hope. And that's progress.
ReplyDeleteWith all due respect...the article is entitled "Can A Radical New Treatment Save Children With Severe Allergies." Kind of hard to argue that's not sensationalist.
ReplyDeleteI've hoped a lot of hope over the years. We've been told a cure "is just 5 years away" now for almost 20 years. Every time this kind of sensational article comes out, there are consequences for food allergy parents. It's very difficult to get people to understand the daily challenges, and once the "allergies have been CURED" sound bite hits the airwaves, it's hard to put the genie back in the bottle.
I'm sure it's hard to be a parent in this study and retain objectivity, just as it's hard for me to be objective about FAHF-2. As a parent who is going through this, how do YOU reconcile the negatives about OIT coming out of AAAAI with participation in this study? Are you worried about your child suddenly developing new allergies?
Unfortunately, I now know at least three people who have participated in OIT who have had this happen. It's not a frivolous concern and I don't find Dr. Shreffler's main objection (that these studies can have unintended serious negative consequences) to be unprofessional at all.
I understand what you are saying - and agree, it should not be positioned as a cure (and Dr. Nadeau does not have any editorial control over the NYT Magazine). I prefer to view the article as hopeful vs. sensational. If anything, I have heard many anecdotal comments that the article gave people a new appreciation of the struggles FA families go through. Re the negatives on OIT - I see this all as part of the normal progression when we are at such an early stage of research. This is how we learn what will work in the mainstream environment. Do I worry about backtracking? Not really. Every day prior to the trial was a worry. If we backtrack, so be it. We know what it's like to live with food allergies. New allergies can develop at any time. OIT was never promised to us to be a cure-all. I feel proud to have been involved in the research that may eventually one day lead to a mainstream cure.
ReplyDeleteChemo doesn't "cure" everyone with cancer either--yet some would call it a cure. AND it does so much damage to the body, that the cancer may be cured and then they die from treatment. OIT is not like this if you are only using your allergen to desensitize you. We'll know this once this generation of OIT patients die of other causes of course.
ReplyDeleteWe could not find a study to participate in at the time my 4 1/2 year old son suddenly became anaphylactic to peanuts but we didn't let that stop us after reading Dr. Burks' study results that the "IgE drops and the allergy just goes away." Continuing, "There is a molecular change in the blood..." And after speaking with the Head of Pediatric Allergy, Asthma and Immunology at Cincinnati Childrens, and our own private allergist (who refused to do OIT), they referred us to Dr. Nash, formerly of the DUKE study for OIT treatment. Both saying he was qualified and experienced and it should work. My son was not going to outgrow the allergy, as a matter of fact, each reaction was getting worse and coming on much quicker after ingestion. The lab that performed a component test for us created anaphylaxis is "less than two minutes." He is Ara h1 and Ara h2 positive. The idea of being in the "Food Allergy Fear Club" for the rest of our lives, or waiting for "the cure," LIVING in fear, SLEEPING in fear, it was all too much when there was a treatment we could TRY--because he had not been diagnosed with EoE, and if he had the underlying medical condition, we would find out soon enough, according to the Head of Ped. AAI at CCH, Dr. Rothenberg, a world-renown specialist in EoE. "It's worth a try."
After a year of increases, and another year on maintenance of 8 peanuts/day, my son's IgE dropped from 90.7 to 17.9. It might possibly be gone by now. We still and will always carry epipens--anyone at any age could suddenly become allergic to any food.
Eating 8 peanuts at dinner is just a matter of fact now. And what none of these articles are telling you that if you FAIL TO MAINTAIN your doses, there is a great chance you'll lose the tolerance (temporary for how long, no one knows?). Private OIT allergists do not let their patients leave without follow up for 5 years to see if they are maintaining their dose. OIT ISN'T FAILING, PARENTS ARE FAILING TO COMMUNICATE WITH THE --what study doctor who changes every few years? SOMEONE IN CHARGE. And if left to their own devices, who knows what desperate parents might do--according to the new Allergic Living mag. they are feeding small amounts of their child's allergen without any supervision from an allergist.
Sure, some will not be able to handle the doses due to stomach pain. Others may find they have EoE. Others will fail to follow the RULES OF OIT or just give up.
I cannot articulate this exactly, but the "blame" you refer to, I think this horrible thing is brewing where the guilt and blame, and the "SEE! I told you it wouldn't work" disease is more crippling than the disease itself. I have to remind myself that MY child is gaining tolerance and losing his IgE daily by following the rules of OIT and staying in touch with his OIT allergist.
I wish you all wisdom to decipher the evidence, if any, when looking for the failings of a treatment that has helped thousands of children. Just because it's not around the corner, and you might have to travel or move for it, and researchers have said it's not ready for prime-time, it's YOUR CHILD. YOU make the decision and don't believe all this nonsense you read. Talk to people who know. Talk to the doctors who know--who aren't sitting on the boards of companies that are attempting to produce alternative "cures" or trying to secure the bottomless pit funding.
YOU will never know, until you TRY!!!
Liseeta, this is the third time in a comments thread like this I've seen you blame the study participants for their failure. ("They didn't follow the rules.") I'm sorry, but I just don't see it as that simple. I don't think all the failures have been due to missing medication doses and, even if they are, 100% compliance to retain desensitization is just too much to expect of children (and teens!).
ReplyDeleteIt's easy to say "you will never know until you try", but some of these studies are finding a sub-segment of the kids actually end up WORSE off, with more sensitive allergies. There doesn't seem to be a way to predict which children are going to fail.
Plus, for many of us, the idea of having our children eating a food regularly and then having a reaction out of the blue is scarier than just taking daily precautions. It's just trading one uncertainty for another one. With food allergy avoidance, you can train your child and gain some control. With new, drop-from-the-sky reactions, the control is completely gone. Yes, children can gain new allergies, but our experience hasn't been that they drop from the sky like this. My son did develop new allergies as a preschooler, but his allergies have been very stable after that point, so suddenly having new allergies would be a huge life change for us.
I am all for taking risks when they are warranted. However, I think this study requires a long second look for most parents. I hope your child continues to do well, but I also hope you can put yourself in the place of the parents whose children have failed this study, and the parent who have valid concerns about the outcomes of these studies. Evangelization without compassion can turn more people off than engage them.
Minor point that I think is worthwhile to make:
ReplyDeleteFAB wrote, "With all due respect...the article is entitled 'Can A Radical New Treatment Save Children With Severe Allergies.' Kind of hard to argue that's not sensationalist."
True. That is a sensationalist title, and it annoys me. Immunotherapy is not new, though doing it orally for multiple FAs is new. Does it promise to "save" children with severe allergies? Oh dear . . . it's much more complicated than that.
I think there were good things about the article and a few things that could have been done more thoroughly, such as explain some of the concerns about OIT in circulation. But I would not write off an article as sensationalist (or otherwise) *based solely or primarily on the title.*
Why? The author **rarely** composes the title to an article in a magazine or newspaper -- generally, that is done by an editor. Hopefully it is a senior editor who knows the nuances of the subject, but oftentimes not. Sometimes designers or layout production artists have a big say in what looks good, fits, and ties in with the graphic treatment.
Anyhoo . . . if you want to hear the voice of the author, focus on the article, not the headline. And don't read too much into the illustrations either -- the author **rarely** has any input on those -- sometimes even editors don't have much say on illustrations, esp. when deadlines are tight! The art comes in last minute, it's a bit "off," but it's too late to do anything.
That that said, it's fair to question the credibility of a periodical if they make a habit of such errors -- it does suggest that the editorial staff is not listening and reading closely and/or sensationalizing on purpose.
I (and others) are not just quibbling with details, or a headline. The main thrust of this article is that there is a viable treatment for allergies that has demonstrated success. It's hard to reconcile this media blitz with the almost-universally bad news that came out of this year's AAAAI with regard to OIT.
ReplyDeleteActually, there is yet another layer to the story, this time a (rebuttal of a rebuttal of a rebuttal!) letter from Dr. Nadeau:
http://foodallergies.stanford.edu/letter.html
She says: "New data suggest that all patients’ long-term responses to this form of food allergy therapy, specifically oral immunotherapy, are not uniform and protection may not last."
A shame that information will never make it back to the "Today" show, or "Katie."
I'm with FAB on this one. I read that article when it came out and it took some effort not to roll my eyes. The author was well-intentioned, I'm sure. However, she seemed uneducated on food allergy research. While Dr. Nadeau sounds extremely impressive (I wish we lived near Stanford), that doesn't change the fact that anyone not up on food allergy research would read that article and think there's been some huge breakthrough on finding a cure. Dr. Nadeau's research is not new, it's a variation (albeit an important one) on what's already out there in trials. And, as Dr. Nadeau has commented many times, this treatment is not easy and does not work for everyone. Quite frankly, the vigilance needed after finishing the trial arguably equals or exceeds that which was required prior to the trial. Also, the fact that the failure to take your dose even for a day or two could cause significant problems is a real issue.
ReplyDelete