OK – I’m back, with sleep having done wonders. When I woke, Orr was already hard at work on the iPad, researching new info we learned yesterday, and the discussion – and awe – continued. [Note: there is A LOT of information that follows. If it’s too much, and you just want to know the bottom line, feel free to scroll to the bottom of this post.]
Yesterday, Dr. Nadeau pre-screened us, ran scratch tests on the boys to get a clear picture of the number/type of allergies we would all be working with, and answered our many, many questions with patience and grace, despite the fact that her offices were being packed up around her, as they are being moved into Stanford hospital space this weekend (from clinic space outside of the hospital). We had some funny moments. Aviv, early on, was sizing her up, then said to Dr. Nadeau, in his unmistakably Avivi voice, “Um, can I tell you something? I like blood tests better than scratch tests, so can I have a blood test instead?” Dr. Nadeau, understandably surprised to hear these kind of preferences from a 4 year old, looked at us. Heck – these kids have been having blood and scratch tests for years; they’re pros. Dr. Nadeau assured the boys that she would do the scratch test herself, and that it would be much less painful than a blood test. There had been a global-scale freak out at our house yesterday morning when A&A realized they would be having a scratch test – screaming “Noooooo! I HATE scratch tests!” with all accompanying waterworks. To be fair, the scratch tests they’ve previously had were done by their pediatric allergist who (as I’ve already alluded to) is, well, sort of the only game in town for pediatric allergists in Marin or SF. We’ve never loved his bedside manner, and feel he takes a less-than-cutting-edge approach, but we never thought twice about his equipment. Well… after seeing the so-easy-you-hardly-notice-it’s-happening equipment Dr. Nadeau used, Orr dubbed the former scratch test equipment that had been used on our kids ‘Inquisition-level torture devices. A&A hardly even broke their attention from the movie they were watching (yes – we brought an iPad with movies and headphones for them to watch, to keep them engaged while we talked with the doctor, reminding us, yet again, never to underestimate the power of the iPad) while she did the pricks. Aviv continued to test Dr. Nadeau – telling her exactly where he wanted the prick points (“no – not here… HERE”, pointing 2mm away) – and was very satisfied. She also used diluted amounts so that she saw the reactions she needed to see without sending them into full-blown itching/scratching/discomfort… another first for us with a scratch test. Bottom line on the tests: Ari appeared to be less sensitive to one of his nut allergies then when previously tested (woo hoo!), and Aviv is still holding strong at being highly allergic to many nuts.
The scratch tests confirmed their various allergies, and apparently we passed the are-they-a-normal-family-who-will-follow-directions-and-not-make-my-study-hellish test, which means we passed the pre-screening! That’s huge. She then told us about the three studies she has open, that are scheduled to begin in October 2011:
1) The first one (a peanut patch, which works like a nicotine or birth control patch, releasing tiny amounts of peanut protein to desensitize the body) is not a good fit for us, as the boys have allergies beyond peanuts. The second and third, however, sound amazing.
2) The second one (“the generic study”, as Dr. Nadeau refers to it) is the standard desensitization protocol that Duke made famous, and that she has been doing for years now: straight oral immunotherapy, which involves giving minute amounts of the allergen to the patient each day, with an escalation dose (i.e. upping the dosage of allergen) every 2 weeks, in order to slowly desensitize the body to the allergen. This study lasts approximately one year, and begins with a very rough week of tests and giving the allergen to the patient in increasing doses to determine the starting threshold level (that is, the highest dosage possible without sending them into anaphylaxis); that is apparently NOT a fun week. Following that week, the protocol officially kicks in: the patient is given pre-measured doses of the allergen at home daily, and then returns to the doctor for escalation doses every two weeks. Over time (usually about a year), the dosage is slowly increased from micrograms to actual serving sizes. By the end, the patient can have – and actually, MUST have – several (4-7) of each allergen nut each day. It’s imperative that the patient continue to ingest the allergen at the ending level every day in order to maintain the desensitization. Once the patient graduates from the study, he is considered in ‘maintenance mode’; there is no indication at this point as to what the future holds (whether there will be a time where they don’t need to eat that amount daily, etc.), so the current guidance is to continue having it indefinitely.
The twist here (from the standard oral immunotherapy studies that we’ve been following) is 2 fold: first, she will be treating 3 allergens at the same time. This means that, instead of Aviv going through the first year treating for peanuts, then beginning a second year of treating for hazelnuts, then a third year of treating for pistachios, etc., he can be treated for 3 nuts at one time – a HUGE time savings toward getting him to a safe place! Aviv has a laundry list of nuts he’s allergic to, so this is key for us. We also learned that some nut proteins are so similar that treating one may give you the cross-benefit affect of treating a second one; in other words, we might get a ‘freebie’ or bonus nut treated by treating certain other ones, so we’ll keep that in mind as we think about which ones to do first. The second twist in Dr. Nadeau’s study is that she has found clean sources for all of the tree nuts! Most of the studies/treatment clinics we researched do not treat for tree nuts because of difficulty in sourcing clean/uncontaminated tree nuts. In fact, the Dallas clinic we spoke to, that does straight treatment (not studies), said that they want to treat tree nuts but haven’t been able to due to sourcing challenges. Dr. Nadeau hit the same wall a few years ago and hired people to reach out to growers (we have the benefit of being in California, where so many of the nuts are grown) to get nuts directly, and received FDA approval to do her own testing for purity (as she’s a biochemist). So, she can treat for all the nuts we need. 3 at a time. Locally. Patients who are our boys’ age. Any one of those facts is amazing and a breakthrough; that all four are present is just a gift that I am so grateful for.
Downsides: the treatment is very, very hard on the patient physically and emotionally. 80% of kids in these studies have physical reactions along the way, usually abdominal pain and/or hives. A few have had more severe reactions (diarrhea, vomiting), but Dr. Nadeau told us no one in her studies have had anaphylaxis from the treatment. They are equipped to handle any of these reactions that occur in their offices, and we will be instructed how to handle them at home, with 24/7 access to the staff for guidance. Some kids even develop new stomach related physical ailments (Eosinophilic Esophigitis) along the way. Additionally, it is emotionally draining for everyone. We have all lived with the framework that nuts can kill our kids, and now we need to give them small doses daily. They can also have a very tough time in understanding what is going on, and why they have to ingest something that makes them feel bad. Finally, as their bodies are struggling to adapt, they are actually MORE sensitive/prone to reactions to errant nut exposure until the study is complete and they enter maintenance mode. It will be a time of heightened diligence and anxiety for all of us. With the number of allergies our kids have, it would likely be one year of treatment for Ari, and two years for Aviv, under this 3-at-once study.
3) The third study (I refer to it as ‘the accelerator study’) is where our eyebrows visibly raised. The third study takes “the generic study”, and accelerates the treatment time through the addition of a drug (Xolair). Initial research by Dr. Nadeau has shown that, when using Xolair on top of the standard oral immunotherapy protocol, the treatment is generally finished in 16 weeks. I’ll say that again: 16 weeks from start to finish; from life-is-dangerous to not having nut allergies. In fact, she believes that at around 9 weeks with the Xolair, the cross-contamination risk (from touching nut oils, etc.) is already gone. Those of you who have seen us wipe down every toy, seat, bench, in our vicinity can imagine what a life change that would be for us. Xolair works to decrease allergic reactions by boosting the T-cell production, and suppressing the IgE antibodies, which reduces side effects/reactions to the allergen and enables the ‘up-dosing’ to occur faster. Using Xolair in this way is already being done by a few research hospitals, including Johns Hopkins, Sinai, and Boston.
Using Xolair is not without its risk and downsides, as you can imagine. Xolair is currently only FDA approved for treating severe asthma in patients over 12 years old (it is approved for kids under 12 outside of the US). It has been known to cause anaphylaxis in some patients, which is why it must be administered in a doctor’s office. There is also some controversy as to whether it is connected to causing cancer, but Dr. Nadeau (and Johns Hopkins) does not believe that to be the case. (See http://www.hopkinsmedicine.org/bin/s/o/Xolairptinfoversion2C.pdf, for more info on Xolair risks.) In this accelerator study, Xolair would be administered by injection into the patient’s fatty tissue every two weeks for the first 9 weeks, then 1-2 times after that until the treatment is finished (I think 6-7 times total). It also doesn’t accelerate treatment in the same way for each patient, meaning that it may enable the treatment to end in 16 weeks, or it might take longer; it will vary by patient. In addition to the possible risks of taking Xolair, and the discomfort of the bi-weekly injection, it is an extremely expensive drug - $4000/shot; $20,000-$30,000 for the course of treatment. For that reason, Stanford is asking that anyone in that study contribute $10,000 (per study) to help diffuse the cost of the medication. (It’s illegal to charge for participation in a clinical trial, so this is not for participation; it’s directly toward the cost of the medication used, if one chooses to be in this study.) This would mean $20K-$30K for us, if we end up being approved for this study, and want to have all of A&A’s allergens treated in an accelerated manner. Just another factor to consider.
BOTTOM LINE: So where we’re at is waiting for Dr. Nadeau’s studies to be approved by the IRB (there’s no indication that they wouldn’t be, as they’ve already been approved by the FDA), so that we can be scheduled to come in for a formal screening/intake. The formal intake is planned to occur in September 2011, with the studies beginning in October 2011. So barring unexpected interventions (and assuming they are accepted into one of the studies), A&A will could begin treatment in nut desensitization studies in October at Stanford; the question is whether to request the ‘accelerated’ study or not. Either way, by summer 2012, assuming the kids are accepted into one of the studies, we could have kids with fewer-to-no food allergies. Hard to believe.
Note: if there’s anyone who wants detailed info regarding the work that is being done in this field, contact me (tinok94941@yahoo.com); I’ve been writing up what I learn along the way, and would be happy to share; I just don’t want to bore everyone here with research info.
