Are Food-Allergy Parents At War With Their Doctors?

My husband and I have often questioned whether our son has the best allergy doctor. Our son sees one of the noted specialists in our urban area. By everyone's assessment, the man is brilliant. He specialized in pediatric food allergies and is clearly knowledgeable in that area.

At the same time, he gives really bad advice. He's very absent-minded. We spend much of every appointment reiterating our son's allergens, past testing, etc. He's fairly conservative and doesn't (so far) support any of the clinical research treatment options. And, he can be very casual about food challenges, telling us to "go ahead and try it at home", something we were not at all comfortable with when our son was younger.

Should we have shopped for a new doctor? So many other FA parents we know doctor shop — some seem to do so constantly. I know people who have been through four or five doctors and who still conclude that the issue is with the doctors and not their expectations. Are allergists really that terrible, or are we simply expecting too much from them?

When you come right down to it, doctors can offer us various diagnostic tests that seem to have less and less meaning as the years go by, prescriptions...and their advice. Once our children are diagnosed, we're basically going back for the hope and the crystal ball, even though every year's "Will he outgrow?" question from us is inevitably answered with "We just don't know."

Most of us are roped in, of course, by the need for that yearly epinephrine prescription. But...if prescriptions were automatically renewed and health insurance covered other possibilities — say, nurse clinicians, nutritionists, anxiety therapists, food allergy lifestyle specialists (don't you wish there were such a thing?) — would we really choose to spend our hard-earned money each year at the allergist's office?

Juxtaposed against all this is our doctors' opinions. There seemed to almost be a tone of blame to some of the reports and tweets from the AAAAI meeting about current clinical trials. Drop-out rates are very high — often 20 to 30% of patients. For the patients who stick it out, one missed maintenance dose (even when it happens because of illness) can cause a reaction and relapse back to very low levels of allergen tolerance. Do our doctors believe food allergy patients just aren't trying hard enough?

Food challenges are another area where doctors and patients can walk away from the table with very different ideas about what happened. What constitutes a food challenge "pass?" For many parents, any acute symptom in the next 48 hours, and mystery symptoms for weeks or months later, end up attributed to the food challenge or subsequent food reintroduction. For doctors, if it doesn't show up in the office, it seemingly doesn't count. How does it happen so often that doctors check the PASS box while parents check the FAIL — all while observing the same child? (About 13% of parents whose child passes a food challenge do not reintroduce the food because of real or perceived continuing symptoms.)

The current running through both sides of the river is judgment. Do our doctors believe us? Do we, as patients, listen to them? Should we always listen to them, when it often seems they know less about how to deal with food allergies than we do? Why do they keep doing scratch/RAST testing on tons of things and handing us results with no explanation of sensitization vs. true allergy? Why don't they help us with our day-to-day lives? Our children's mental health? Stand up for us with schools?

On the doctor's side of the river: why aren't parents giving epinephine when we've told them to? Why are parents still giving foods they know cause an allergic reaction? (Remember the Pediatrics study?) Why do they expect so much more from us than medical diagnosis, pharmaceuticals and occasional lab tests?

The river of misunderstanding is very wide. And, even if we're able to eventually build a bridge to better communication, there are often still a lot of bad feelings that have already flowed under.

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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.

	April	October	January
RAST	0.77	1.1	1.71 (class 2)
SPT	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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BTDT, Got The FAHF-2 Food Allergy Clinical Trial T-Shirt!

Both...I think.

My son loves clever t-shirts. He got an opportunity to wear the one at left for a totally new outing this week: the FAHF-2 clinical trial.

As I mentioned in a post from last month, our family applied to the FAHF-2 clinical trial at Children's Memorial in Chicago. Getting in was actually a little iffy because my son's peanut numbers are so low. (Despite the low numbers, he had failed a peanut challenge last summer.) To participate, candidates had to be over the test threshold for SPT/RAST, have controlled asthma, be allergic to one of the allergens being studied (peanut, tree nuts, sesame, fish, or shellfish), be between the ages of 12 and 24 and not have a history of an allergy to corn or of a serious past reaction that required intubation or resuscitation.

Our initial visit included a thorough exam and consent paperwork for both me and him, since he's still underage. They took blood for a RAST (in our case, for both peanut and hazelnut to see which they preferred to challenge). They also did a skin prick test, a spirometric assessment of his lung function, an EKG, urinalysis and a general physical.

The next day, we got a call to say his peanut RAST was just over the 0.7ku/L cut-off. His SPT was also just over the line: 3.5mm, and it took until the very end of the time period to show up. Everyone shrugged and said perhaps we'd be celebrating him passing BOTH food challenges (the peanut and the placebo). The numbers were so low!

On the day of the food challenge, we got to the hospital at 8:30. He was allowed to eat up until 2 hours before the trial, as food in the stomach can help dampen reactions. However, he was not supposed to eat too close to the trial for the opposite reason - vomiting is common and they wanted food that was digested enough to not cause choking. Luckily, my teen-age wolf is able to eat anything at pretty much any time of day, so breakfast at 6:00 was no hardship.

The clinical research area is a very busy place! My son was only one of several test subjects there for the day. The area is divided into little clinical rooms that basically contain a treatment chair, some procedure carts and enough other chairs for the various people who come in and out. My son took the Chair of Honor and the nurses worked on getting an IV line in for him, a challenge given his strange veins. The doctor did another exam to make sure his health status had not changed from the initial exam, and asked him to blow into a peak flow meter several times so they could get his max. level. They took another set of blood from the IV line. Then we were ready to go.

The clinical trial manager brought into the room a big bin, filled with applesauce. There were two batches, labeled "A" and "B", divided into 9 doses. Should he finish them all, we were told, the total potential peanut dose was 2000mg, the equivalent of around 9 peanuts.

I did not get the dosing amounts during the trial, but they did tell us that the doses double and then double again, so this is about how many milligrams were probably in each dose*:

1	2	3	4	5	6	7	8	9
10	20	40	80	160	300	400	500	600

1 peanut = ~225-250mg

Because the trial was done "double blind", no one in the room knew which dose was going to contain peanut and which just applesauce. What we did know was that, if he did not react to the first batch, they would wait 2 hours to be sure and then go right into the second batch. No doubt every mother in the study whispered a prayer at the beginning of the day: "please let the first batch be placebo so this can all be over in one day!"

They started the dosing. Because of the delay in the reaction time on his SPT, the doses were spread out over a half hour, instead of the usual 10 minutes between. Around dose 4, my son started complaining of a tightening in his throat. Both the doctor and clinical trial nurse were with us and both asked for a number for the discomfort (2) and whether he wanted to continue. He did. We all really wanted to confirm that he was truly still allergic, given his numbers.

After dose 6, things started to get much worse. In the course of 20 minutes, his discomfort went from a 2 to a 7. The two clinicians looked uneasily at each other. They did a physical exam, listening for wheezing, and had my son blow again into the peak flow meter. His peak flow was down more than one hundred points. Additionally, I could see he was starting to panic.

"I'm calling it," said the doctor and the relief on the clinical study nurse's face was evident. They offered my son either liquid or IV push Benedryl (he took the liquid) and we all watched him like a hawk for the next half hour while it took effect. There were two other clinicians popping in at times now and asking how he was feeling. Finally, we all burst into laughter and the doctor said "we need to coordinate this better so we're not driving the poor guy crazy!" I laughed and said "hey, at least it's not just me bugging him for once!" The Benedryl kicked in quickly and everyone relaxed into the 4 hour observation period. They made sure we had our meds with us and sent us home around dinnertime. As fails go, it was as good as we could have hoped for.

The fail point? Just under 3 peanuts, according to the staff.

Monday, we girded our loins and drove back to the hospital for a repeat with Batch B. While we were all anticipating a fast, easy placebo day, there were no guarantees. Over the weekend, thoughts of psychosomatic reactions, sensitivity to something in the applesauce and EoE all went through my head. The good news is that it was indeed uneventful - he ate a bunch of applesauce, they waited two hours, and then they gave him his first dose of FAHF-2.

The pills are not small. They are a half-inch each in circumference, a little bigger than an M&M. Over the next six months, he will take THIRTY of them daily, 10 each with breakfast, lunch and dinner. Yesterday, I met with the school nurse to give her the permission slip, dosing schedule and medication. My son will need to stop by her office each day after lunch to take his mid-day dose. (For some strange reason, they object to teens popping 10 unlabeled pills at lunchtime in the cafeteria.)

From here on out, he will need to talk with the study coordinator once a week to report any issues. He will keep a journal to record medication dosage times and any illnesses or funny symptoms. Since these are natural substances that have a long track record in Eastern medicine, they do not expect side effects, but they are possible. We will return to the hospital for an exam and blood work every few months.

At the end, they will put him back through the two food challenges to see if anything has changed. If he is taking the placebo, they would expect to see a fail at about the same point as last time; if he's taking the real drug, we will have to see what happens. The ratio of real-to-placebo is 2:1, so we have good odds of getting the real drug.

I asked him after what the hardest part was and he replied, without hesitation, "discontinuing the antihistamine!" Apparently even the palms of his hands itched! However, that does put things in perspective. While he did not look forward to failing a food challenge, he's done it before. As fails go, this one was really very mild  — no vomiting, no wheezing, moderate sense of doom, no major drop in blood pressure. We feel very lucky. However, it's also an important reminder: low numbers need to be tested once a history of allergy exists. It is very possible to be allergic with low numbers, just as it is possible to not have an allergy with high numbers.

The good news about this trial is that, if it works, it probably works for every allergen. As I mentioned, they did pull a RAST for hazelnut as well as peanut. Between January and this week, the number went from 3 to 12! My husband was very unhappy when he heard this. However, I reminded him that it's spring. It's possible that the spike in RAST is from a cross-reaction to birch pollen, not a real allergy to hazelnut. (My son has never reacted to hazelnut IRL.) The PPV for hazelnut is not well-determined, so it's hard to know if that 12 is important, but we will no doubt have to test this at some point down the road. (Hazelnut is a hassle because it's in so many coffees, so cross-contamination would be a serious issue.)

The expectation, as the trial continues, is that his RAST will go up....and then come down. No one knows why it works this way, but that seems to be the pattern, almost like the immune response has to be turned on before it can be tamped down.

If you are in the Midwest and interested in a trial, here's the link to the Children's Memorial research page. Our trial manager did mention that they are planning two more trials for 2012: one for the peanut patch used in Europe, and an oral tolerance study for wheat (not gluten intolerance/celiac, but true protein allergy).

*Based on the total of 2000mg and knowing he failed at Dose 6, which we were told was the equivalent of about 3 peanuts. 


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