Thursday, January 24, 2013

When Worlds Collide: Introverted Mom/Food-Allergic Kid

I know this is going to seem crazy to a lot of you, but the supermarket deli really stresses me out.

I'm a pretty extreme introvert. I would be very happy puttering around the house by myself and never going to social events at all. For years, I worked a corporate job and found that I had to "gear up" every morning. It isn't that I don't like people. It's just that too much "people" exhausts the heck out of me and confrontation sends me back into my shell like nothing else.

So...back to the deli. We have a great deli at our local supermarket with lots of safe choices for my son. Unfortunately, I cannot remember which choices are safe from visit to visit. I'm also just paranoid enough about all this stuff, having been burned in the past, that I really want to see that label.

There's a line of people three deep at the counter. Thirty-EIGHT...thirty-NINE...FORTY?

I'm forty. "Hi. I'm really sorry about this, but can you please show me the label for the oven-roasted turkey?" Blank stare.

"I have a child with food allergies. I need to see if there is butter or soy in the flavorings." Ok, now he's following. He rifles through the top shelf (always the top), looking for a turkey breast with the label intact. Turns back to me. "Lady, I'm going to have to go in the BACK to get one." Pause.

"Well, is there any kind of turkey right there that does have a label?" He brings me what he says is the honey roasted. Looks great. I tell him to carve it.

When he brings it back, he says "you know this is the smoked, right?" Nope, I didn't. I take it anyway and slink back to my cart.

That's a pretty typical trip to the deli counter for me. I always apologize, always explain, always assume it's a big deal, am always hypersensitive to what I perceive as criticism and annoyance from others, always quick to settle. Who knows if that hypersensitivity has any basis in reality at all? But that's the view I have of the hostile outside world and it makes doing the things I need to do every day to keep my kid safe harder than they probably are for the extrovert mom.

Now that I'm watching my son grow up with many of the same characteristics, I've gotten more curious as to where this stuff all comes from. The answer seems to be: we're born with it. If you, too, recognize yourself in all of this, I highly recommend Susan Cain's book Quiet. It's been a breath of fresh air through my mostly indoor-air world.

Cain makes the point early on that, around the 1910-20s, America went from a culture that valued character to one that values primarily personality. How to Win Friends and Influence People was the name of the game. Shy went from being simply a character trait to being a detriment...and sometimes even a pathology. Shy kids today are pushed, prodded and therapied. Colleges and companies want the socially-involved extrovert.  (As the same time, we're surprised that Americans are so "me" focused, and that our schools pay for programs that teach though character is something to be acquired through mimicry, just like any other social skill.)

Unfortunately, food allergies and introversion are not an easy mix. Over the years, I learned to put on my game face and make the calls to other parents about play dates, or to speak up at the planning sessions for class parties, or to ask the restaurant owner to trot out all the ingredients. But, I often wondered if my child wouldn't have been better off if he had been born into a family with a pushier mom. (And yes — I know not all extroverts are "pushy" — but my crazy mental world likes broad categorizations.)

There are a lot of recommendations in the book for living more easily as an introvert in a world geared mostly to extroverts; so many that I can't summarize here. But I think the first important step for us introverts is acknowledging the mismatch and refusing to own the "shy" label as a negative. I've learned over the years that the outgoing interactions needed to deal with food allergies are hard for me. I've found ways to make it work (including throwing my husband into the ring whenever possible). What I hadn't realized until I read this book is the toll the struggle took on my own self-esteem. For so long, I thought there was something wrong with me, rather than some explainable hard-wired temperament that was simply different than what society (currently) values.

If you, too, are an introvert constantly struggling with being Hard-Nosed Pushy Allergy Mom, I highly recommend the book. In the meantime, cut yourself some slack when you ask the man to cut your deli meat.

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Friday, January 18, 2013

The First Big SLIT Trial Just Ended...

...and the results are...interesting.

For those of you who are not obsessed with the current smorgasbord of clinical trials underway, SLIT stands for sub-lingual immunotherapy. The therapy has been used successfully in Europe for many years to treat environmental allergies. It's been used more sporadically and with less certain results to treat food allergies. I know of at least one clinic in the United States that has been administering SLIT for several decades.

The question has been...does it really work? Other trials have shown mixed results. (I wrote an article on this back in July if you're really interested.) This most recent study was a more comprehensive approach involving 40 kids, sponsored by the National Institute of Health and held at several locations.

Kids who participated were given either placebo or drops containing peanut protein. About a third of the kids in the peanut drop group experienced an itchy mouth or throat, but only a few had symptoms more severe than that. (However, one subject did have an anaphylaxic event after a dose at home and ended up dropping out of the study.) At the end of the 44 weeks, the kids who suffered through dose after dose of saline for nothing got to choose whether to participate in an accelerated higher-dose SLIT experiment over the next 24 weeks. Kids in the first peanut group just continued with their slower build-up.

The kids varied a lot with regard to how much peanut they could tolerate at the outset. For some kids, the first symptom occurred at just 6 mg. Keep in mind that a peanut is about 300 mg, so this means these kids could detect 1/50th of a peanut. However, the actual dose they consumed before having a objectively-confirmable reaction was as high as 196 mg, or 2/3rds of a peanut.

So what was interesting about it?

It worked...kind of. Of the kids in the original peanut group, 14 out of 20 were able to consume 10x the amount of peanut after SLIT as they did before. The problem was that many of these kids did not get up to a very high dose at the start, so 10x the amount of peanut was still not very much peanut. The median dose they achieved at the midpoint of the study was 496 mg (about 1 2/3 peanuts). At the end of the 68 weeks, the median was 996 mg, or just over three peanuts. This is definitely some significant wiggle room with regard to cross-contamination, but it's clearly not full desensitization, at least for most kids.

The kids who got the shorter course of peanut drops after placebo did almost as well. There were seven "responders" out of 16 in this group (some people dropped out along the way for various reasons, including fear of more challenges and even pregnancy!). The median amount they could eat after just 20 weeks of SLIT was that magical 496 mg number.

The amount of time SLIT was given did make a difference in a few cases. The study goal for desensitization was 5 whole GRAMS of peanut (5000 mg). During the 44-week challenge, no one made it to full desensitization. However, after 68 weeks, three of the kids were able to consume 5 grams (16 peanuts), and one ate 10 grams (32 peanuts).

Peanut-specific IgE levels didn't go down. The kids who got the peanut saw their IgE levels go up at the beginning of the dosing, then back down toward the end. However, in the end, the level of IgE ended up at about the same point as when they started and wasn't any different from the placebo group.

However, there was a noticeable difference in IgG4 levels: in the peanut kids, they went up much more than with the placebo group. Just as with good and bad cholesterol, it may be that a change in the "good" number (IgG4) is a more important marker of tolerance than the "bad" (IgE) number. Skin tests also changed significantly for the peanut kids. Bottom line is that IgE doesn't really seem to be telling us much with regard to development of tolerance.

Spontaneous tolerance DOES occur. Here was the weirdest part of the study for me: two kids in the placebo group  were actually able to pass the 16-peanut challenge at the end without any real therapy. Keep in mind that these were kids who had already failed a challenge just a few months before (one got just hives and itching; the other got hives, plus felt sick).

The study authors just kind of shrugged about this one and said "hey, we really don't know how this all works and maybe even older kids, or kids whose IgE isn't all that low, can spontaneously develop tolerance." One of the kids saw a decrease in IgE/increase in IgG4; the other saw an increase in IgE and a decrease in IgG4. No help there!

So what changed? Maybe the time in the year the kids were tested made a difference. They were both teen boys, so maybe testosterone kicked in and suppressed inflammation. Whatever the reason, both kids are now openly eating peanut.

So...if you're anything like me, you found the information about SLIT interesting and the information about the kids who got placebo and passed anyway INTERESTING! You can tell when you read the study that those kids really mucked up the nice, neat results. Sometimes, though, it's the thing that you're not looking for that ends up being the most important part of a research study.

If you'd like to read the whole complicated study for yourself, you'll find it here.

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Thursday, January 17, 2013

The Food Allergy Bitch Manifesto

This week is the 1-year anniversary of this column. That's why I'm always surprised when I get comments from readers who challenge themes that have appeared in the column over and over. (I realize people do not read every column...but still!)

So today's post is the Food Allergy Bitch Manifesto. These are things I believe, that I write about constantly, where my opinions are not likely to change. If you disagree strongly with most of these then you're probably not going to like me or what I write very much!

1. Don't call your or your child's condition an allergy if it doesn't conform to the clinical definition of allergy. A food allergy means something specific to doctors. A food allergy involves the immune system. Part of the reason the term has become so meaningless over the last 20 years is that people who have food intolerances, or who even just don't like a particular food, have appropriated the term.

I am never going to be o.k. with that. This kind of truthiness affects our children. People discount the life-threatening nature of their condition because others are using the term inappropriately. If you come to my web page or Facebook page and comment in this way, I am going to call you out on it, every time. Which brings us to...

2. Follow the money and consider the source accordingly. There are a lot of people in this industry who are making money off of frightened food allergy parents. A LOT.

I'm not saying you should discount everyone in the food allergy world who makes money. There are many people who have started businesses in this area specifically to help others. But a funny thing happens when money comes into the picture. Rather than alienate potential customers, many advocates who run businesses simply loosen up their standards. You suddenly see topics creep into their support materials like "clearing allergies" through NAET, or IgG testing, or magical wooden bands (still my favorite!). If challenged, they say "it's just posted for discussion." They want to have their allergy-free cake and eat it too.

I have seen several examples over the last year of situations where I think money played too great an influence. An advocate with a busy support group who set up a PayPal account for donations to defray the costs of her personal health situation. A new food allergy foundation whose only purpose seems to be to collect cash, without any promise as to how it will be used. Advocates who also just happen to sell bracelets, or advice, or books. Advocates who have so intermingled their personal and professional lives that their child outgrowing an allergy is something that can't be publicly admitted.

No they're not all corrupt, but monetary motivators should definitely be factored in when evaluating a source of food allergy advice.

3. Be respectful of allergies, not reverent about them. Allergies are something to be managed, not worshiped. There is no "true believer" way of dealing with them, no right words, no absolute truths. The truth is that researchers know little and moms often know even less.

It's so easy for habit to become dogma before we even know it. The next thing we know, we're eviscerating some poor fellow mother on a chat board because — gasp! — she doesn't follow the (sometimes crazy) rules we've created for ourselves.

It's no secret that I think people should push past their comfort zone. Ask doctors about treatment options. Ask about challenges. Ask about necessary vs. unnecessary precautions. If needed, get a psychologist involved to address anxiety issues. Learn to live in the boat with the tiger with every tool of mastery you can find. No one has all the answers, even the consultants who tell you they do (for the right price).

4. Don't surround yourself solely with what makes you comfortable. It is completely possible with the advent of the internet to build oneself a fantasy sand castle of thought. If you don't like what someone says to you, only visit sites that tell you what you do like to hear. Or, better yet, find or even create a community of people who only reinforce what you already believe.

There's a huge danger with the internet. Anyone can be a publisher or a community organizer. Anyone can say whatever they want to say. That's why we've seen such a rise in conspiracy theorists: it is now literally possible to find someone else who believes what you believe, no matter how crazy it is.

I guarantee you  — what you think about food allergies is not what your family, or friends, or teachers, think. Yes, they may be wrong in many aspects of their thinking, but you are not likely to completely change their thinking through education. They, too, have built sand castles. There's value in hearing and understanding  other competing viewpoints.

There's a concept in psychology called projection: ascribing blame to someone or something in the outside world that are really all about our own inner battles. When we read something about food allergies that bothers us, that makes us think, that we discuss over and over on chat boards or with friends, it's a good signal that we're internally conflicted about our choice. (People who don't experience that conflict simply walk away without another thought.)

Conflict is good. We should always be questioning. Too much time with "Mirror, mirror, on the wall" never ends well.

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Monday, January 14, 2013

FAHF-2 Clinical Trial Summary

As promised, here's the update on the last round of clinical food challenges. I've seen both sunrise and sunset today, but I want to do it while it's all fresh in my mind.

I generally do not like to give specific details about my son's situation, but I know a lot of you are invested in the stats so in this case, I'll make an exception.

1.71 (class 2)
3.5 mm
~3.0 mm?
(not sure about this one)
No reaction
Peanut consumed
496 mg
~9 peanuts
1746 mg (almost 6 peanuts)

Please keep in mind this is just one kid, and there's no guarantee the other kids will have patterns at all like this. However, it's interesting that a) the RAST number went up pretty significantly, and b) the amount of peanut tolerated after 3 months off the medication went down slightly.

I'm going to do the rest of this in a Q&A format, since I basically spent the whole morning asking questions of the clinical trial manager and on-call physician. Again, keep in mind these are only their opinions. Actual mileage may vary.

Q. Will the tolerance we saw with peanut extend to his other allergens?

A. No reason to think it will not. The formula has been used in Eastern medicine for all allergens. (We will work with our own physician to pursue new RAST testing and challenges if appropriate.)

Q. Once the trial ends and the medication is available again to trial participants, is there a recommendation for how it should be taken? 

A. This is an open question at this point. However, in Chinese medicine, the tradition has been for people to take the medicine for nine months and then take three months off. This was probably because two of the ingredients in the original FAHF formulation had some liver toxicity associated with them. Those two ingredients were dropped from the second (FAHF-2) formulation for that reason. As a result, the thought is that patients may need to stay on the medication life-long.

On the other hand, the tolerance may last. No one really knows.

Q. What route will be taken for commercialization? What's the timeline?

A. Right now, it does look like the researchers are pursuing an FDA approval (vs. going to market with a "dietary supplement"). This will ensure the widest availability. However, it also takes a little longer.

Q. So what happens next?

A. The medication has been reformulated in a more concentrated form. That form will need to be tested for efficacy in Phase 3 clinical trials just starting in Dallas. (Heads up, Texas residents!) Participants will take 10 pills a day, 5 in the morning and 5 at night. This should significantly reduce the issues with compliance. (One of the issues they had with the Phase 2 trial was the difficulty for kids of getting in three doses, with food, without dosing as school since that's difficult for many schools to manage.) If the current trial shows positive results and the Phase 3 trial also succeeds, the researchers will pursue commercialization. That's probably still a couple years away.

Q. So was the trial successful?

A. Obviously this is what we'd all like to know! However, even if she could have shared it with me (which she can't at this point), our clinical manager indicated that she really doesn't know. 1 in 3 kids in the trial were receiving placebo, so it's impossible to tell the difference between a child who didn't respond to the medication and one who didn't receive the medication.

Q. What does success even look like?

A. There are two separate outcomes that will need to be evaluated to determine whether the trial was successful. First, did children show an increase in threshold? My son's experience was a definite yes: depending on which food challenge you look at, he showed an increase between 3X and 5X in the amount of peanut he could consume before a reaction occurred.

The second measure of success is severity of reaction. This one is trickier to measure because, while this trial attempted to use objective symptoms before calling a food challenge, subjective symptoms were used if they were persistent. There's obviously some anxiety for these kids going into a food challenge, so they are going to be more aware of all their bodily sensations. Since the amount of peanut is often tied to severity of reaction, it will be hard to evaluate whether the reactions were milder because of the medication, or whether the kids just got anxious and bailed.

Important to note: this is more my interpretation of what may have happened, not the researchers' opinion. Unfortunately, the researchers could not share specifics about the other kids at this point, other than to say there was a range of response with regard to both threshold and reaction severity.

Q. Was the change in RAST what they expected?

A. Well...sort of. Our trial manager said my son's RAST probably went up due to the known peanut exposures, even though tolerance increased. I was under the impression that they expected RAST to go up, then come back down, so it will be interesting to see what happens with the rest of the kids in the trial.

Q. When will the information from the trial be made available?

A. Probably end of summer, 2013. The last participant is finishing the main part of the trial in June.

Q. Is there any thought that kids should be taking a daily dose of peanut to help maintain tolerance?

A. No. That's outside the scope of this trial, there's no continuing supervision to make that happen, and there's no guarantee at all of how long any increased tolerance will last. (The tolerance was achieved without any peanut consumption at all, so maintaining it would have more to do with the medication than with actually eating peanut.)

Q. What changes can the kids in the study make to their diet, now that the study has completed?

A. Really, none. In our particular case, the researchers were pretty secure telling my son that cross-contamination was not a real concern. However, I clarified today that that's primarily because his starting threshold was already so high. All the kids in the study are definitely not being told this. In general, the advice is to continue to strictly avoid peanut and always carry epinephrine. (In addition, they reiterated that reactions are unpredictable -- the mild ones we experienced as part of the study are no guarantee of future mild reactions.)

Q. Is there any thought that my son's milder reactions/slow response time perhaps are because he's really allergic to pea and just cross-reacting to peanut?

A. According to the researchers, very unlikely. A peanut allergy seems to be most often be what it appears to be: a true peanut allergy. Different people just respond differently.

Q. Are we still "just five years away from a cure"?

A. This is a little inside joke among my food-allergy friends. I've been told "just 5 years" for almost 18 years now.

However...our clinical trial manager's opinion on this is that one of the trials they're working on will definitely pan out into a usable treatment. The hard part for me to hear was that she's not necessarily betting on FAHF-2. She spoke with a great deal of enthusiasm about both the oral immunotherapy (OIT) with omalizumab (Xolair) and the peanut patch trial currently underway. However, that may just be because those trials are the new kids on the block. We'll see when the data is correlated from all the reporting sites whether FAHF-2 is a go.

I think that was everything I thought of to ask. If you do have a specific question I didn't answer here, post it in the comments. It's possible I've already asked it and just didn't note it here -- if that's the case, I'll add it in.

Also, if you're just finding my blog, here are the other posts specifically about FAHF-2 in order:

FAHF-2 Trials In Chicago!

We're In

BTDT, Got the FAHF-2 Food Allergy Clinical Trial T-Shirt

Brief FAHF-2 Update

Halfway There...But the Second Half Is All Uphill

FAHF-2: The Holy Grail?

Waiting in the Wings for the Show to Begin

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Wednesday, January 9, 2013

Guess What? Docs Now Get Paid for Oral Food Challenges (OFC)

I've spent a lot of time in the column complaining that parents are too timid when it comes to insisting on an oral food challenge to confirm their child's allergy. As I've said elsewhere, there are a huge number of parents who believe their child has an allergy based on testing only, when those kids really have a harmless cross-reaction to pollen.

Let's run those numbers for fun, shall we? There are around 76 million kids in the United States. According to FARE (love the new name!), about 8% of parents believe their child has a food allergy, so around 9.5 million kids.

However...researchers say a good portion of these kids are sensitized, not allergic. In one study, of 11.8% of kids who showed up on a peanut panel as sensitized to peanut, only 1-2% actually demonstrated an allergy when challenged. That's just 17%. Studies have varied on the sensitization-to-allergic ratio, ranging from 20-50% of OFC fail rates after a positive skin or blood test, but the number is huge.

Depending on which ratio you use, we're talking about between five and eight million kids whose parents believe they have an allergy, but who really don't.

 Why? Why in the world is there so much uncertainty with something that should be so easy to demonstrate?

The reasons are complex, and I've talked about many of them before. Some of these children are too young to reasonably challenge. Much of the time it's because parents are not willing to tolerate a few hours of anxiety and discomfort for their child (in a carefully controlled environment) to have a firm answer. Doctors sometimes underestimate the social and psychological challenges of living with food allergies and don't want to press anxious parents. However, there's another reason that infuriates me: doctors simply weren't getting paid enough to make these challenges worthwhile for them to conduct. 

You read that right. More times than we would like to admit, U.S. healthcare is predicated on whether a doctor is actually reimbursed for a procedure. And guess what — until this year, oral food challenges were reimbursed by insurance companies using a diagnostic code that didn't fully cover the time required to perform the challenge. As a consequence, some doctors just didn't bother. (How many of you have been told "we don't do challenges in this office" in the past?)

The good news is that the coding issue has been fixed. Two new codes have been added that allow doctors to bill for the staff-heavy first two hours of a challenge, and then on an hourly basis for food challenges that run longer than two hours.

It's infuriating that something so simple has stood in the way of more parents getting a definitive answer about their child's food allergy. I'm happy to finally see the financial incentives being aligned to address this issue for physicians. It would be great if the parents' emotional incentives could also be appropriately aligned.

That's where support groups and advocacy organizations come in. If you manage one of these groups, for heaven's sake, stop telling your members that food challenges are something to be feared and avoided! It's in everyone's best interest to identify the kids who are truly allergic: both so that those children can get appropriate social support and so children without a true allergy can stand down from a baseless fear.

A food challenge done in a proper setting is about as risky to your child as a vaccine. It's time to put the risks of oral food challenge in perspective and consider more strongly the benefit of knowing.

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Tuesday, January 8, 2013

Waiting in the Wings for the Show to Begin

So almost three months has gone by since my son's last FAHF-2 trial food challenges. We are scheduled to do the last set of them in a few days.

What has really changed, I've asked myself repeatedly. Was it worth it? 

My son has been pretty angry the last couple of days. He had a bit of a meltdown last night and told me that my presence at the challenges was making his life hell. I realize that I'm getting the brunt of the stress and anxiety directed at me because I'm the safe one to target, but it's still hard. He's without antihistamines and it's taking a huge toll. Plus, this is all happening right before finals (there was no way to schedule it at a different time).

The point of this set of challenges is to see if the tolerance my son had gained in October is still present three months later. The mouse studies have been very encouraging. However, there's also an element of Flowers for Algernon in all this. There's the feeling that it can't last. Can a medication really permanently change the user after just a few short months of use?

What does change even mean in this case?  Does the FAHF-2 medicine reset the immune system, or retrain it in some way? (I think that's what most researchers think.) Does it create an environment where the balance of good bacteria needed to symbiotically "tag" proteins in some way to pass them through the intestinal wall is magically restored? (This is more what I think.) Does it work in some other mystery way? It's really weird to be using a medication where no one has a clue why it works or what it does. While the side effects of this medication are minimal, the science of the medication is actually pretty far out there.

One fun new option -- Aero bars
(through a dealer in North Dakota
who buys them in Canada)
"What has changed?" you ask. Well, we've been a LOT more casual about cross-contamination and new foods. I now make my daughter's Nutella and peanut butter sandwiches with a (gasp!) real knife on our kitchen counter. This Christmas was filled with new brands and even with items that probably had either peanut or milk contamination. Because he's still allergic to raw milk (we think), we have not had a lot of truly new options, but we are a lot less concerned about trying a new brand of a food we're already using, like bread or chips.

The irony is that these foods probably wouldn't have caused a problem before the trial. One of the useful things we learned from the trial was just how high our son's threshold for peanut really is. A lot of the fears I had about cross-contaminated foods, pans, etc., seem silly in retrospect. In a sense, the study has given me permission to shake off the party line of food allergy training over the last few months.

I realize that will make a lot of people reading uncomfortable. There is no way to know what a child's threshold will be at any given time, or what the true allergen content of a "may contain" food is, so there's always some risk. However, one of the things this study has brought home to me is that we will always be taking a risk from this point on. We are never going to know if/when this medication wears off. We are never going to know with 100% certainty what he can tolerate...until he actually tolerates it. We are always going to be pushing the envelope and need to be prepared for reactions. (That will be especially true as we re-introduce baked milk, as soon as this round of challenges completes.) The clinical trial is over, but the real experimentation for us really starts now.

One of my readers asked if we're going to start adding daily peanut after the trial. Great question. His new tolerance hasn't depended at all on actually consuming peanut. Would daily peanut expand his tolerance balloon even further? That will definitely be something to discuss with the clinical researchers and with his own doctor.

The bigger question for us is: is this a reset on all his allergies? Should we pursue a straight-up milk challenge? Go back to baked milk for a while? Run his RAST numbers and see where we're at? Pursue component testing for hazelnut to see if we can knock it off the list? All of the above?

I suppose when we signed up for this trial that I was hoping for change. I'm clearly getting what I wished for. We don't know what we're walking into at this point, but we do know we've come far enough that we're not going back.

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