Not all Sunshine & Roses

There can be a darker side to participating in a peanut clinical trial as a mom in our community recently discovered.  We had a "sunshine and roses" food challenge experience, i.e., it was all good.  Her and her son....not so much. With her permission, I thought it important that you hear her story.  And, don't worry, it's not all doom and gloom.

They had a rough go of it right from the start.  Her son was one of the original and unlucky participants in the SLIT trial at Duke that was impacted by a lab snafu and had to re-start the trial.  This was after having already driven back and forth for months.  She lives a couple of towns over from me, and it's a long drive.  I can attest to how horrible it would have been if Abigail had to start over.  In her son's case he had been on the placebo drops and would have had to begin again anyway.  In my opinion, I think that's somewhat a blessing.  I think it would have been even harder to bear if a child had been on the peanut protein and still had to start over.  Fortunately, these children were guaranteed that they would receive the peanut protein drops when they re-entered the study.  Needing a break, they didn't immediately re-enter and ended up starting back after us.  So, with Abigail's food challenge success fresh in her mind, they showed up for their 8 a.m. appointment.

He received the placebo during the morning challenge.  During the peanut flour challenge that afternoon, all was going well, and he was showing no clinical signs (rash, hives, runny nose, stomach pains, vomiting, etc.) of a reaction.  By the next to the last dose though his mom's gut instinct was kicking in, and she was ready to call it quits.  It was that final dose that did it, and her son went into full anaphylaxis.  From her account, our doctor and nurses handled the situation fabulously.  They gave him Benadryl, and were ready to wait to see if that was enough.  Seeing her child the reddest of reds, covered with baby hives and having difficulty breathing, she insisted that they give him an epinephrine injection.

Having made it through all the doses, I can just imagine the shock of seeing the worst of reactions with no signs leading up to that point.  Our doctor recorded that he was able to tolerate 8 of the 9 doses.  Her question though, and a very valid one, is what if it was a delayed reaction?  What if given more time between dose increases, he would have had a reaction at a smaller dosage?  Without another food challenge, it's probably impossible to say. And, given her experience, she confirmed that that wasn't going to happen again anytime soon.

Now, for the positive.  Bottom line, he was able to consume peanuts, and with a starting IgE number of over 200 that's significant.  He probably could even consume enough to eliminate considerable worry about the possibility of cross-contamination.  And, more importantly, her son is no worse for the wear!  He still takes his drops without worry.  Can't say the same for mom.  She's a little traumatized over the whole experience and says knowing that after consuming an unknown amount of peanuts, he can go from 0 to 100 without any type of warning had her doubling the amount of Epi Pens they kept on hand.  She also feels guilt over having put him in that situation to begin with.

They're sticking with the study. Like us, I think they feel blessed that they do have the opportunity to participate.  I know so many of you readers pray for that time when either the end results of these clinical trials are available for you or your children or such time when a clinical trial comes to a location nearby.  We do this with the full realization that we're providing our children a different path down life's very difficult journey.  Having had to experience an anaphylactic reaction really stinks, and it's not something even our doctors want to have happen.  But, in her case, it was part of providing that different path...that path to becoming peanut allergy free!

Summer Time!

I think this is been one of the longest times between posts since I started my blog.  What's my excuse?  Summer!  The kids are home, and if they're not off making a mess and getting into something they shouldn't (specifically my 3 year old son), they're fussing or fighting, needing a snack, complaining about being bored or wanting to go somewhere.

There was the food challenge at Duke, then Vacation Bible School.  After that, we started potty training my youngest.  It went surprisingly well, and so far no pee pee accidents.  Can't say the same for the other.  Regardless, it's a huge time commitment.  I also made a promise to Abigail that she would be able to swim the length of the pool by the end of the summer so there's been swimming lessons for her and my youngest (he wouldn't even get in the water 2 months ago) and trips to our neighborhood pool to "practice".  Can't forget the shuttling to summer camps, special outings and play dates which all require time away from the computer.  I've started a training certification program which I'll write about in more detail later.  And last, but not least, the garden.  I love having a garden, but my goodness, it's a lot of work.  There's definitely a science behind gardening, and I haven't come close to mastering it.

Anyway, I haven't forgotten you guys.  I hope you are also enjoying your summer. I really shouldn't complain, we're having a great time.  We're being inundated with reminders that school is just around the corner, and I'd like to savor this time a little longer.

Look what we found!!

During our food challenge at Duke a couple of weeks ago, our nurse mentioned that she had purchased a candy bar made with sunflower butter at World Market.  The other night we were in the area of our local World Market so we stopped in to see for ourselves.  Look what we found!!

Nut Free Sun Cups!  Remind you of anything??  What a treat!  Abigail has never eaten a Reese's Peanut Butter Cup, and I can't remember the last time I have eaten one either.  But, this is no ordinary chocolate treat.  It's made in a nut free facility, is organic and is gluten free!  Seth Ellis Chocolatiers in Boulder, Colorado took it a couple of steps further.  They use Fair Trade chocolate, the Sun Cups are Kosher certified and the foil outer-pack is home compostable.  I mean...wow!  Here's the link to their spec sheet if you want to see the full ingredient listing.  By now, though, you are probably wondering how they taste.

The Sun Cups are available in both milk and dark chocolate.  We sampled the milk chocolate cups first (actually they're a blend of both milk chocolate and white chocolate).  Now mind you, we (my husband, son and I) eat sunflower seed butter on a daily basis so we've acquired a taste for it.  Abigail will occasionally eat some on a cracker, but it's not a staple food for her like it is the rest of us.  As to be expected, the cups have a slight sunflower seed taste, but the chocolate is nice and firm, and it's not oily in the center like it's peanut butter counter-part.  Abigail loved them both, but my favorite was the dark chocolate. To me, it had a more rich chocolate taste than the milk chocolate Sun Cup.  They were a hit with all of us, and we had to refrain from opening more packages.

I contacted Seth Ellis Chocolatiers to get some more information.  You can currently purchase these online at www.peanutfreeplanet.com and while Amazon.com has them listed, they're not yet available.  When they told me that World Market is not going to continue stocking them, I took the kids for a little shopping spree (maybe if everyone went on a shopping spree, World Market would change their mind).  The list price for the Sun Cups at World Market is $1.99, but this last weekend they rang up at $1.50.  Today when I purchased them, they were $ .99.  Seeing that, I doubled what was in my basket.

I had another thought as I piled over a dozen packages in my basket today.  If all of our prayers are answered, in another year and a half, Abigail will be through with the clinical trial, and we will be adding peanut products to her diet in order to maintain her tolerance.  One of the issues for children coming out of the clinical trial is that they dislike the taste of peanuts...call it a self-preservation instinct...yet they have to consume a certain amount on a weekly basis.  At some point, I'd planned on eventually working sunflower butter in Abigail's diet so that she'll hopefully have an easier time acquiring the taste for peanuts.  Considering she scoffed down a Sun Cup immediately upon getting in the car today after our shopping spree, this is definitely one way to start.

Cross-Contamination Concerns

The last couple of weeks, the peanut allergy message boards have been full of posts discussing companies' labeling policies.  One post that was concerning involved a teenager that had an anaphylactic reaction to Hershey's Rolo Caramels.  Someone responded to that post stating that she had spoken at length with a supervisor at Hershey's.  He told her that the majority of their products were manufactured on shared equipment with peanuts/nuts, and that the 1.5 oz Hershey bar was the only one made on a dedicated line.

The Hershey's allergen statement on their website reads as follows: "We take food allergies very seriously at Hershey and have strict procedures in place to prevent crossover of allergens into other products that do not contain the allergen. In instances where we have a concern about possible crossover by an allergen we take the added precaution of including an allergy information statement on the label."

Now my question is how many companies use shared manufacturing equipment, clean it and consider that they've removed all possibility of allergen cross-contamination??  It you believe Kashi's website information, it's impossible to remove all traces of peanut/tree nut..."Scientific evidence has shown that consumers with peanut and tree nut allergies can have a severe reaction to amounts that are below the current detectable limits based on existing technology."

I spent over 2 hours the other night searching the internet for some study or article that would validate either position, and didn't come up with much.  I did find the issue well stated in a 2008 study introduction published in the Journal of Food Protection, "Although allergen removal through cleaning of shared equipment or processing lines has been identified as one of the critical points for effective allergen control, there is little published information on the effectiveness of cleaning procedures for removing allergenic materials from processing equipment. There also is no consensus on how to validate or verify the efficacy of cleaning procedures."  Now, if I could only get access to the results of that study!

I found a ton of food industry articles on how to manage food allergens in the manufacturing processes as well as information on the type of tests available to test for allergen residue on equipment. A group from the University of Florida studied the effectiveness of commercial allergen test kits.  Their results were that the three common cleaning protocols regularly used in the food industry did not yield the same results. Some were better than others.  Does this mean that food allergy savvy parents need to ask what test kit a manufacturer uses to verify that there lines are clean and that there is no chance of cross-contamination?

In 2001, the Senior Health Policy Adviser for the Grocery Manufacturers Association offered testimony on the challenge of labeling food allergens. The speaker addresses the challenge of cleaning ingredients like peanut butter on manufacturing equipment.

Still in disbelief!

I'm getting lots of e-mails, Facebook postings, blog comments and excited greetings.  I can't thank you guys enough for your support.  Truth be told though, I'm still very much in disbelief and not quite sure how to express my feelings about the success of the food challenge.

Realistically, nothing changes. Abigail still takes her 8 drops a day, holds them under her tongue for 2 minutes and can't eat 15 minutes prior or 30 minutes after. She'll continue to do this daily for at least another 18 months until the end of her treatment.  We're to make absolutely no changes to our eating habits which means I'm still reading every label and our family will continue to avoid unsafe restaurants.  Abigail will still bring her own cake to birthday parties, we'll still ask friends and family to not have peanut products sitting out when we visit and I'll still meet with her next year's teachers and classmates and put the same protection policies in place at school. We're to always have her Epi Pen and Benadryl handy.  In other words, we continue to live day to day under the assumption that there's always a chance for accidental exposure.

I know that at some point her passing the food challenge with flying colors will set in.  I think that at some future time, even if I can't relax regarding what she eats, maybe I'll relax when it comes to social settings. Those situations that I currently give my o'kay, but worry about.  For example, lunch time in the cafeteria at school.  I worried about her sitting in the same spot that someone eating a peanut butter sandwich just vacated.  I worried at family functions when there was a safe dessert tray and an unsafe dessert tray.  I worried about friend's birthday parties, sleep-overs, church events and camp.  And, that list goes on and on.  You can't do that much worrying for 7 years and have it go away over-night.

It's really an emotional roll-coaster.  I'm sure it's confusing to Abigail as well.  She ate the equivalent of almost 10 peanuts.  Her doctor is smiling from ear-to-ear, she's getting hugs and treats, told how brave she is and then, by the way....you still can't eat anything with peanuts.

So, with some reserve, we're celebrating in the short term, but we're also still looking forward to the long-term.  There's quite a journey ahead with lots of unanswered questions.  Maybe a few more days of congratulations, and then I think we have to file this experience away until such time when we can truly celebrate.  I really think the best part of our food challenge experience is to know with confidence that we are getting the real stuff and not the placebo, that the SLIT methodolgy is working, that our time is not wasted and that we made the right decision to put Abigail through all of this.

Thanks again everyone for your support.  I attached a few pictures from our day at Duke.

It's 8:00 a.m. and Abigail is ready, although somewhat nervously, for her big day at Duke.











I've included these pictures so you can see the difference in her skin prick test between this week (1st picture) and her skin test in January.

I.V. is in and we're ready to start the food challenge.

Of course there were lots of treats.  Here we are enjoying a new DS game together.

This is it.  Last dose of the day.  She doesn't look any worse for wear does she?

A Successful Food Challenge!!

She did it!!  Abigail consumed all 9 doses of peanut flour today with no reaction!

I don't even know where to start.  There's so much to tell.  First though, I want to thank Dr. Kim and our RN's, Alice and Jan, for ensuring that Abigail's day was as pleasant as possible given the agenda.  I'd also really like to thank all of our family, friends and you guys, my readers, for keeping us in your prayers today.  God was listening!  I still can't believe it.  Depending on whether you use 240 or 300 milligrams as the average peanut size (there are mixed standards), Abigail ate the equivalent of 8 to 10 peanuts today.  Our family has much to be thankful for!

We started at 8:00 a.m. with the dreaded saliva test.  For whatever reason, Abigail hates spitting in that tube.  Next they did the skin prick test, and the results were better than 4 months ago.  With the use of numbing cream the insertion of the I.V. didn't hurt.  I wonder if Abigail has a future as a nurse because she always watches and even helps change the test tubes during the blood draw. With all of that out of the way, the Benadryl pre-measured and Epi Pens handy, she ate her first dose at a little after 9:00.

The first dose is just 5 milligrams.  Our doctor says it's uncanny and wonders if it's some sort of protective instinct, but the kids usually can taste even that minute amount.  She did, but said confidently that it was the oat flour. Ten minutes later, she ate the 2nd dose, 10 milligrams.  The doses continued, some met with a curled nose and followed by a drink of water, but she took them all without hesitation.  They were mixed with cinnamon applesauce and went from 5 milligrams to 15 milligrams, 50 mg, 100 mg, 250 mg, 500 mg and then 1000 mg.  By this time I had also smelled the mixture and hid my disgust.  Also, by this time, she had consumed the equivalent of 3 1/2 to 4 peanuts.  Dr. Kim was 99.9% sure that she was getting the peanut protein (remember it's double blinded and could have been the oat flour) so I was getting a little antsy.  Before each dose increase, they checked Abigail's breathing and skin for symptoms.  The next dose was 1500 mg and the final dose was 1580 mg.  Each of those doses were the equivalent to 2 1/2 to 3 peanuts each.  She coasted through.  I didn't allow myself to be super excited yet.  I didn't want to be disappointed if that did turn out to be the oat flour.

We had a 2 hour lunch break.  After Abigail had eaten her favorite, bagel with cream cheese, her stomach started to hurt a little.  It didn't stop her from eating her chocolate pudding or playing her Nintendo DS so that was a good sign.  Later that afternoon, I realized that she was still under the impression that she had eaten the oat flour which makes me wonder if it was a nervous stomach over the next challenge.

At 1:30, we started the process again.  For a change, the Dietitian mixed the flour with vanilla yogurt which worked well.  It was fun to watch Abigail's light bulb moment when she looked at the remaining 3 doses and then looked at the doses of Benadryl and exclaimed that she hadn't needed those.  You could see her realization that she was making it through with flying colors.  We finished those last 3 doses and by 3:00 were finished.  After final confirmation from the Dietitian that she had indeed had the peanut flour first and seeing the report that she was getting the real thing and not the placebo, there was some celebrating!  Abigail's was the 35th food challenge in the Peanut SLIT Clinical Trial.  She was one of 9 that was able to take all of the doses.

So, what's next.  We continue doing exactly what we've been doing the last year.  She'll take her drops daily, we'll continue to eat peanut and tree nut free and continue to avoid all chances of cross-contamination.  We go back in 3 months for a "check-in" visit and to get more drops.  At 6 months, we go in for labs, at 9 months we're back for another "check-in" visit, and at 12 months, another food challenge where they double the dosages she received today.

Again, thanks so much for all of your prayers and well wishes.  It has been a wonderful day!

Food Challenge Time

It's finally time. We've been participants in a Peanut Sublingual Immunotherapy Clinical Trial for over a year. May 18th marked our one year anniversary and June 23rd marks our first food challenge. Come 8:00 Wednesday morning, Abigail and I will be at the Duke Clinical Research Unit nervously and anxiously waiting to begin.

I've been quite excited waiting for this day to come.  Abigail has been more on the nervous side.  I've given her all the details I think she can handle.  I've clarified that they are not going to take her to the point of her having an anaphylaxic reaction, and it was evident that she was relieved.  Now, the day before, I'm getting a little anxious as well.  I just so badly want to see good results!

Here's what our day looks like. We start right off with testing.  Abigail will have to immediately get an I.V., then have blood drawn, have a skin prick test and spit in a tube for a saliva test.  Around 9:00 a.m. we'll start the 1st of 2 food challenges.  It's a blinded challenge so one will be peanut flour and the other oat flour.  The staff in the kitchen actually makes the call as to what comes first.  We're not supposed to know until after both challenges, but I hear it's pretty hard to not smell the peanut flour.  The flour will be mixed with applesauce.  I'm also bringing chocolate pudding, cinnamon applesauce and because she occasionally eats sunflower butter, I'm bringing sunflower butter and crackers to give her some variety.

There should be no issues with the first couple of doses.  If I'm reading my notes from our last Duke visit correctly, by the 4th dose, she'll be getting 100 milligrams, 5th dose, 250 milligrams, etc.  The 9th dose is the equivalent of 8 to 10 peanuts, over 1500 milligrams.  If she can tolerate it, they'll stop the challenge at the 9th dose.  There's a 2 hour break, and then the process is repeated with the second challenge.  It's going to be a long day.  We're expected to wrap up between 5 and 6 o'clock.

They'll be monitoring her the entire time.  Benadryl and Epi Pens will be right there, and of course, she'll have the I.V.  Every few minutes they'll check for a reaction.  Our doctor and a nurse will be there, with another nurse stopping in periodically with a new set of eyes.  We're looking for sinus issues, hives, stomach pains with possible vomiting.  Any of those symptoms will stop the challenge.  Her history of stomach aches adds a little complexity.  Her stomach hurts when she's nervous so we'll have to push through that.  That's also why they do a blinded challenge with both peanut and oat flour so they can rule out a psychological reaction.  According to her doctor, the biggest sign of a reaction is a change in behavior.  He says that the kids will be playing their Nintendo DS, watching a movie, reading a book, etc., and then all of a sudden, they stop and go lay down, kinda withdraw.  Small children will crawl in their mom's lap.

We're taking lots of movies, and I've got my bag of treats packed.  It's a big day for Abigail.  The good news is that they're seeing a clear difference in the study results between the children getting the peanut protein and the children getting the placebo.  At the end of the day, Abigail's file will be unlocked and we'll see what she's getting.  I'm 99% sure that we are getting the real thing, and I'll be embarrassed if we find out that she's been on a placebo all this time.  I really don't think so though.

According to our doctor, based on the 40 plus food challenges already completed, they know that the sublingual immunotherapy works, the question now is how to make it work better.  Keep us in your prayers on Wednesday that it works for us.  I'll post an update Wednesday night.