Four Months & Two Weeks

We had our 10th visit to Duke this week.  We've been part of the Peanut Sublinigual Clinical Trial now for 4 months and 2 weeks.  I'd like to say we were halfway done, but I can't.  We've still got over 7 months to go before we do our first food challenge.

While we were at Duke this week, a mom and son came in for their last visit before their food challenge in December.  As we get closer and closer to Abigail's challenge, there will be more weeks between visits and fewer dosage increases.  This family was up to their highest dosage and were now just going every 6 weeks.  They are going to be either the first or second participant in our study to do the food challenge.  I was all ears as Dr. Kim was describing what was going to happen on the day of the challenge.

If the kids can tolerate it, they will be given the equivalent of 6 peanuts.  The results of the first challenges that occur in December and January can really impact the study.  If the kids can tolerate the peanut flour than that's fabulous news for us.  Talk about motivation!  If there is a high failure rate, then Dr. Burks and Dr. Kim will make modifications to the study.  Not sure what that means.  Larger dosages, more frequent increases?  Worst case scenario is that we have to start over on the peanut flour study.  The doctors really don't expect that to happen though.  There has actually been an adult on a similar sublingual study who did pass the food challenge.

I asked about Abigail's blood test results from our last visit.  I wanted to find out if her IgE number had changed.  Unfortunately, the results will be locked up until the food challenge.  Even Dr. Kim will be kept in the dark.  Abigail did have another skin prick test at this visit (she did fabulous).  Dr. Kim explained how her results could actually be worse than the initial baseline.  He did 8 pricks, 5 were peanut of various strengths, 1 was the saline prick and the last two were histamine pricks (Dr. Kim thought Abigail moved so he repeated the prick).  The histamine prick serves as the control.  If there is no reaction, then the test is faulty which is what happened at our last visit.  So, we watched and waited for 15 minutes.  The histamine pricks (the two on the bottom right side of her back in the picture) immediately formed welts and large red areas around the welts.  The first 2 pricks, the higher strength peanut pricks also formed welts and red areas.  The 3rd highest strength prick formed a pimple like place and was barely worth measuring.  The 4th and 5th strength prick didn't do anything.  That's a huge change from our first test where every prick reacted.

Do we get excited??  Is she already responding to the drops?  Afterall, it's only been 4 months and 2 weeks.  I asked if it was possible for her to simply be out-growing the allergy.  According to Dr. Kim, for peanut allergies, if a child doesn't out-grow it by the age of 5, they usually don't. Okay, so I'm just a little excited.  If we hadn't had a faulty test at our last visit, I'd be a lot more excited.  I'm still hesitant to start celebrating.  However, it's hard to complain or get worked up over having to drive almost 3 hours to Duke every other week.  Instead, I feel even more blessed at having the opportunity to do this for Abigail.

What's an IgE? An Introduction....

I've been wanting to post about IgE numbers for a while, but it involves science and medicine, neither particularly strong subjects for me.  I'm on the opposite end of the spectrum with interests centering around art and design and creative thinking.  So, why even tackle the subject?  Unfortunately, it just keeps coming up.

In conversations, parents of allergic children almost always get around to telling each other what their child's IgE number and/or Class is.  It's pretty much the only definitive description we can say about an otherwise very uncertain physical condition.  My daughter is allergic to peanuts.  Her IgE number is 14.10 kU/L, and she is a Class 3.  The number is up from the last time we had her tested when she was 4.  It does not mean that she is becoming "more allergic".  Her IgE number only tells the likelihood of her having a reaction.  At a 14, I know she has a 95% chance of having a reaction if she ingests any peanut protein.  What I don't know is when or if she'll have a reaction or to what degree of severity.  I don't know if the reaction will only need an antihistamine or require the dreaded EpiPen.  I don't even know how she got her allergy or if she'll have it her entire life.  That IgE number is the only known in a very scary world of unknowns.  We parents hold onto that number.  But what is it really?

There are 3 ways to determine if someone has an allergy.  The most definitive, most expensive and most risky is a food challenge.  The patient starts with a tiny amount of food and continues to ingest until the first sign of a reaction.  If there is a reaction, then the person is allergic.  If not, they're not allergic.  Usually the amount of food is so small that a patient might just break out in hives or maybe vomit, but there is the risk of  anaphylaxis.  At Duke, whenever a food challenge is administered (at least in the clinical trials) an IV is inserted as a precaution.  Abigail is not scheduled for a food challenge until spring of 2010.

Another allergy test method is a skin prick test.  In this test, the skin is pricked and the allergen in question is applied.  If there is an allergy, the prick area swells and the skin around it gets red and itchy (almost like a mosquito bite). The test can be used for both environmental and food allergens.  While this test is uncomfortable and somewhat subjective, it is less expensive and more reliable than the next method which is the blood test.  About.com does a good job describing and comparing both of these tests in layman's terms.  According to the site, blood tests are becoming more useful in determining food allergies because they measure the specific amount of allergic antibody to a food.  The downside of blood tests, however, is they tend to give more false positives and negatives, and may indicate an elevated antibody, i.e., an allergy, which may or may not necessarily equate to an allergic reaction.  It's from the blood test that the IgE numbers and Classes are assigned. 

Blood Test (RAST, CAP-FEIA, ImmunoCAP)

The RAST test or radioallergosorbent test detects the amount of IgE that reacts specifically with a suspected or known allergen (Wikipedia).  It's an older test and many labs are using a non-radio active test like the CAP-FEIA or ImmunoCAP.  Duke University Medical Center uses the CAP-FEIA.  It's important that you know which test your doctor is using, but I'll get to that later.

So what is an IgE?  I'm using a definition from kidshealth.org for Immunoglobulin E (IgE).  It's the simplest definition I can find online.  "IgE is a type of protein in the body called an antibody. As part of the immune system, it plays a role in allergic reactions. When a person is allergic to a particular substance, such as a food or dust, the immune system mistakenly believes that this usually harmless substance is actually harmful to the body. In an attempt to protect the body, IgE is produced by the immune system to fight that particular substance. This starts a chain of events leading to allergy symptoms."  For example, airway constriction in asthma, local inflammation in eczema, increased mucus secretion in allergic rhinitis and potentially fatal drop in blood pressure as in anaphylaxis (again from Wikipedia).   However, perhaps our nurse last week at Duke explained it best.  As she described it to Abigail....the peanut soldiers think they need to fight peanuts but we're training them not to.

In a discussion with Dr. Kim at our last visit to Duke, I learned how the IgE number is determined.  Peanut protein is adhered to the inside of a test tube.  The patient's blood is then poured into the tube, left to sit for a controlled amount of time and then shaken.  The peanut antibodies in the blood will stick to the peanut protein.  In other words, the antibodies in the blood "attack" the protein in the tube much like it does in the patient's body.  The extra blood is then washed off and the blood that is attached to the protein is measured.  That amount is the IgE number.  The Class is something assigned by the particular lab running the sample.

I've found a RAST scale that I want to post.  I also want to discuss a warning about how the big laboratories use different standards when reading the results.  There's also more on the topic about what the IgE numbers actually mean, i.e., chance of out-growing the allergy and chance of having a reaction.  But, I can just picture eyes glazing over with the amount of information thus far.  So, until next time....

Today's Visit to Duke

This is going to be short because frankly, I'm exhausted.  It was a big day for us, but I knew you guys would want to know how it went.

I made a mistake in my timing of telling Abigail what today's visit would entail.  I couldn't tell her too early or she would make herself sick with worry.  She fell asleep in the car right before we got there so I didn't tell her until we were walking into the medical building.  When I told her that it might be the appointment that they do the skin test, I "forgot" to mention that they would draw blood at the same time.  I couldn't exactly carry her through the building to the clinic if she decided she wasn't going to go, right?  Besides, we were already late (I'll get to that in a minute).  She handled it well.  She commented that hopefully it wouldn't be today's visit, but then changed her mind because she had brought two of her Build-A-Bears and thought that was a good thing. 

All went smoothly until she found out about needing to draw blood.  I had a time even getting her to agree to put the numbing medicine on her arms.  She obviously hadn't had enough time to process getting stuck.  After a few tears and much discussion, we got the numbing cream on and taped up and then moved on to the skin prick test.  After more hesitation, i.e., lack of cooperation, Dr. Kim was able to do the test.  It really is painless.  He marked her back with a pen in about 8 different places then did a tiny scratch at each place with a different dosage of peanut allergen, one salt water scratch and a histamine scratch.  I believe he said that the salt water scratch was for those patients that have very sensitive skin and/or prone to excema and acts as some sort of measurement standard.  The histamine also serves as a measurement guide.  Dr. Kim explained that her reaction today should actually be worse than her reaction from the baseline skin prick test they did when we started the study.  By dosing Abigail with a daily peanut protein, her body was, for lack of better words, "agitated."  Her body would initially "over-react" to the peanut protein, but theoretically, as she took more and more of the peanut protein, her body should get accustomed to it and stop reacting, or at the very least, react less than the baseline.

While painless, a skin prick test causes major itching and discomfort.  So, with a little hand fan to help with the itching, I was poised and ready.  Nothing happened. Well, almost nothing.  All of the marks got a pimple looking place, and the third scratch mark (not even the strongest dosage scratch) got a little red around it, but compared to the first test back in May, nothing!  As to not excite anyone by thinking that we've already seen a remarkable development after just 4 months, we have to assume that it was a faulty test.  It will be repeated at our next visit.

So far, the trip has not gone very well, and it's now time for the blood draw.  Thankfully, Abigail has had some time to come to the realization that she could be brave or we could call in 4 nurses, but that either way, she was leaving there minus some blood.  First stick wasn't successful, and our nurse had to try her other arm.  Second stick hit the mark, and all was well.  At this point, my very "brave", tearless little girl is helping change out the tubes.  There were 6 in all, and she put on 4 of them.  She swears that it was a piece of cake (minus the first stick that hurt) and that next time will be no big deal.  I didn't bother to remind her that she pretty much said the same thing 4 months earlier.  To give her credit though, at our first visit to Duke her IV needle had to be inserted twice (first time the needle was too large).  She had every right to be unhappy with needing to draw blood today with that experience fairly fresh in her memory.  Our nurse loaded Abigail up with treats, and we were finally on our way home.  Abigail is showing off her two bandages in the picture.

Our 9th visit is over and done with.  Abigail is now taking 4 drops of her solution and will continue to do so every day until we go again, 2 weeks from today.  We've got another skin prick test to look forward to.

Thanks for keeping us in your thought and prayers today.  We made it through the day!  Getting ready for the trip was much easier today, and we got on the road with time to spare.  Not 2 miles from our house though, I dumped almost half a Wendy's tea in my lap, had to circle back, change clothes and clean up the car making us late yet again to our appointment.

So much for a short post

Now for Some Good News!

I thought I'd post some good news for a change.  The last couple of posts have been troublesome first with the news of ConAgra and their "proprietary" manufacturing information and second with the telling of how bogged down I was getting over our trips to Duke.

It's time to shout out praise for General Mills.  I hate to even mention ConAgra in the same sentence, but like ConAgra, I sent an e-mail to General Mills asking about their allergy labeling policy.  Again, trying to find out how they label for products manufactured in the same facility or using the same equipment as products containing peanuts.  Here is their response:

Thank you for contacting General Mills concerning ingredients in our products.  As manufacturers and consumers, we understand your concern about potential allergens in the foods you eat.  Our primary goal is to provide accurate information; and we believe this is best accomplished by referring to the specific ingredients listed on each product package.  This is the most current information for your needs.

If one of our products contains any of the top 8 allergens (peanuts, tree nuts, dairy products, eggs, soy, wheat, crustaceans, and fish) or if it contains sesame, sunflower or mollusks, that ingredient is always listed in the ingredient panel, and also in bold letters just below the list of ingredients.  If a product is exposed to any of these allergens in the manufacturing facility the allergen will be listed in bold in the ′Contains Statement′ just below the list of ingredients.  This list is your ingredient assurance for that package.  It is not intended for other packaging of the same product.  Ingredients may vary from one package to another due to product reformulation.  If you have allergy concerns, please read each package ingredient panel.

This means I'm now a huge fan of General Mills.  Not only do they include a few additional allergens over and above the top 8, but if a product is manufactured in a facility with an allergen, the allergen is listed in the "Contains" statement.

We're all familiar with their cereals, Cheerios, Trix, Lucky Charms, Chex, but also Cascadian Farms, Fiber One and Nature Valley.  Some of their other brands include Betty Crocker, Pillsbury, Bisquick, Fruit Roll-Ups, Progresso, Green Giant, Old El Paso and Haagen-Dazs.  Now, if we could get them to drop the high fructose corn syrup, artificial sweeteners and partially hydrogenated oils we could enjoy even more of their products.

Our next visit to Duke is this coming Wednesday.  Be thinking about us.  Abigail has to have blood drawn and another skin prick test performed.  And me, I have to be rock solid keeping her brave and distracted through each procedure.

Stressful Trip to Duke

We had another appointment at Duke last week.  I had to go back and look at my last post to see if this one was our 7th or 8th trip.  The appointments are all starting to run together.  This appointment was quite uneventful in that we saw no significant reaction to the increase in drops (2 drops of 1/10 solution, up from just 1 drop) and there was no opportunity to ask her doctor questions that I could later blog about.  Abigail even ordered the same food (which is the highlight of her visit) as the last several trips.  So, why was this particular trip so stressful?

Anyone that knows me, knows that I've got a major Type A personality.  The preparation (and we all know that Type A's have to prepare) for this visit just about did me in.  It was our first appointment with Abigail being in school.  It was also preschool orientation for my 2 year old son... his first day going to school, seeing his classroom and meeting his teacher.  And, that evening, a parent meeting at his school.  One of those meetings that if you're late and the last in line for the volunteer sign ups, you end up having to either host the class Christmas party or be room parent.  You moms know what I'm talking about.  So, there was a strict time schedule for the day, and I couldn't miss a beat.  I also had to have snacks and lunch packed for the car, the "Duke" bag packed with the remaining drops, daily log, etc. for the appointment, my son's diaper bag with extras for his stay with my mom, the note for Abigail's school, and so on.  To top it off, emotionally, it was a big day because my sweet baby boy was starting preschool.  Add it all up, and I was a stressed out, sick to my stomach mess. 

Here's how it played out.  I got Abigail out the door to school at 6:50, got my son and myself packed up and to church by 9:00, got him all settled in his new class, sat through a parent orientation, swung by the church library for movies for the car trip (it's a long one), picked him up and got to Abigail's school by 10:20, checked her out and got both kids settled with snacks by 10:30, made a quick drive-thru stop for caffeine, passed out brown bag lunches (didn't stop for that) and pulled into mom's driveway at 12:15, was back out minus my son and heading to Duke by 12:30, parked and late to our appointment at 1:15, checked out of Duke at 3:10 and back to mom's house by 3:50, through the McDonald's drive-thru (yuck!) at 4:30, finally pulling into my driveway around 6:30, kids in bed by 7:15, back at the church for the preschool meeting at 7:30, home with glass of wine in hand at 8:45 and lights out at 9:45.  Minus the evening meeting, this is what I've got to look forward to every other week for the next 5 months.

I knew it wasn't going to be easy.  But, wow, how physically draining.  My husband is going to work from home once a month and take over getting our son to and from preschool.  That'll mean that he can stay at preschool the entire morning, and I can eliminate the extra packing and drop off at mom's.  Meantime, I've got to focus on the big picture, on what our family hopes to gain, on Abigail's future.

In this picture, Abigail is sporting her backpack.  This visit wasn't much fun for her either.  This summer we played games to pass the time.  This fall, instead, she has to do her homework.  Our next visit is this coming Monday.  Please keep us in your thoughts and prayers.  For me, that I don't get bogged down with the preparation details, and for Abigail, because next visit is going to be a difficult one.  She doesn't know it yet, but they're going to do a blood draw, saliva collection and skin prick test.

Bad News from ConAgra Foods

I received a very disturbing e-mail today.  In a previous post, I wrote that I was in the process of contacting major food manufacturers regarding their product labeling.  By law, food manufacturers must include a "Contains" statement if their product has any of the top 8 food allergens in the ingredients.  They do not have to include a statement regarding whether their product is manufactured in a facility or on the same equipment with a product that contains these allergens.  Given the risk of cross-contamination, people with severe food allergies should not consume foods processed in either of these conditions.

One of the companies I contacted was ConAgra Foods.  It's a huge conglomerate of highly popular, highly consumed brands.  The list of their brands is too long to include them all, but here are a few:

• Chef Boyardee
• Healthy Choice
• Kid Cuisine
• Hunt's
• Van Camp's
  
• Orville Redenbacher's
• Marie Callender's
• Banquet

We really try hard to avoid all foods with high fructose corn syrup, trans fats, partially hydrogenated oils, artificial sweeteners or high sodium content.  This eliminates a lot of their food from our shopping list.  However, we do still purchase quite a few of the ConAgra products.

I received a response from ConAgra today regarding my inquiry into their labeling policy.  Here it is:

Thank you for your request for more information about the ingredients in our products.

We comply with Federal regulations for allergen labeling.  These regulations require all major food allergens to be listed in plain language on the ingredient list, and/or be noted in plain language in a 'Contains' statement appearing just after the ingredient list. For consistency, ConAgra Foods always uses the 'Contains' statement. The allergens we list will include any of the eight major food allergens that are used in ConAgra Foods products. The major food allergens as defined by regulation are Crustacean Shellfish, Egg, Fish, Milk, Peanut, Soy, Tree Nuts, and Wheat.

Allergenic ingredients will be listed in the ingredient statement and will be noted in the Contains statement if they are included in flavorings or spice mixes. Please keep in mind that product formulas do change occasionally, so it is important to read the ingredient statement each time you purchase the product.

ConAgra Foods would like to help you with this request to the best of our ability. However, because the information you have requested is considered to be proprietary and a trade secret of ConAgra Foods, we are unable to supply this information.

If you have any allergen concerns outside of the Top 8 Food Allergens, we recommend you do not consume the product and consult your physician.

We appreciate your patronage and value our consumers.  We hope you will continue to enjoy our line of quality food.

Proprietary information, trade secret....really???  You can't tell your allergic consumers if the food they are eating is safe??  I understand that ConAgra is a really big company and that their food is probably manufactured in facilities around the world.  I also understand that it would take tremendous effort to document every food manufacturered on every line in every one of their facilities and then coordinate their package labeling to reflect their processes (although other manufacturers do).  Why not just say that?  How is telling a consumer with a peanut allergy that the food they are eating was made with equipment also used to make a product containing peanuts a violation of a trade secret?  I feel one of my infamous "soap boxes" coming!  Is it possible to boycott this company and not purchase any of their brands?  I'm about to find out!  Poor Abigail, it was a really big treat for her to be able to have a "fast meal", i.e., Kid Cuisine.

Follow up to Post:   I had someone recommend Ian's as an alternative to Kid Cuisine.  I went on their website, and they do have a very healthy, nut free kids meal.  It doesn't come cheap though.

Back to School

Abigail started school this week.  We are looking forward to a fun and successful year in 1st Grade!

Every fall, moms and/or dads and their school age children hit the stores in droves shopping for a new backpack, lunch box, paper, pencils, erasers, markers, tissues and the list goes on and on.  It's a very exciting time as we cross each item off our Required Supply List provided by the school.  For many parents, after verifying the bus schedule and going to open house to meet the teacher, school preparation is done.  For parents with allergic children, the preparation has just started.

I've spent weeks prior to school starting creating the tools necessary to keep my daughter safe in school.  There's the Food Allergy Action Plan, the letter to her classmates' parents explaining what they can do to help, the Medical Authorization Forms that have to be signed by her Pediatrician, new EpiPens and Benadryl for the classroom, letters for the bus drivers, a safe snack list, peanut safe treats for her to eat in lieu of store-bought cupcakes, etc.  I've also met with the Principal, had a one-on-one meeting with her new teacher and a phone discussion with the school nurse.

Our school has been great!  I know that's not always the case, and many parents have to really go to battle for their allergic child.  My meeting with the Principal was very productive.  My main purpose was to discuss the Clinical Trial at Duke.  Abigail has to miss school to participate.  Right now, we are going every other week.  Based on the appointment time restrictions and the lengthy drive, I'll be picking her up early from school for each visit.  She'll miss a full day of school for each Food Challenge.  I am excited though because during our meeting, I mentioned that I had a letter that I would like to send home with each classmate explaining the seriousness of Abigail's allergy and some precautions that everyone could take to make the classroom a safe learning environment.  The Principal asked that I forward it to him.  He ended up e-mailing it to all the teachers in the school to use if they had a student with a peanut allergy.  I made a difference!!  My husband now jokingly refers to me as his activist wife.  

My meeting with Abigail's new teacher was also very reassuring.  Surprisingly, she has never had a peanut allergy student.  We had a clean slate to work with.  We went over where Abigail would sit in the cafeteria, the fact that Abigail couldn't have table clean-up duty, what information any substitute teacher would receive, everywhere Abigail's medicine had to go, the clean-up procedure for when they ate snacks in the classroom, requests for class parties and other celebrations, etc.  Isn't it amazing the details that we have to address??  Her teacher was fabulous through it all!  At Open House, she sent the letter and safe snack list home with each of the parents and even asked that they consider sending peanut free snacks to school each day something that I didn't ask for.  She is also requiring that each student wash their hands upon arriving to school, after coming in from the playground, after eating snack and after lunch!  I'm so pleased about that.  Not only because it creates a safer environment for Abigail, but also because it'll make a healthier class during cold and flu season!

Here are a few of the documents that I provided to the school.  In each case, I was unable to find one on the internet that totally fit my needs, so I either drafted one, or modified one I found online. 
Peanut Allergy Letter for Classmates
Peanut Safe Snack List
Peanut Allergy Letter for Bus Driver

The Peanut Allergy Action Plan does not upload properly to Google Docs.  You will need to contact me for that file.  My e-mail address is listed under "Contact Me".  I do have to thank a member of my PAK group for the Action Plan.  It was a great idea.  I've condensed it so that it's much smaller, made lots of copies and laminated them.  The teacher has 3 (one to post at her desk, one in the sub folder and one for the first aid backpack).  I gave Abigail's morning and afternoon bus drivers a copy and put one in with her EpiPen that goes everywhere with us.

Enough for this post.  I'm working on a Part 2 to the Back to School Post.  We've come a long way emotionally since Abigail was 2 and starting preschool for the first time.  For all you moms out there that are sending your little one to school for the very first time and are freaking out...it does get easier.