Photo by Rebecca Gould Photography

Sunday, June 21, 2015

Big, Big Decisions

It is a terrible, overwhelming feeling to realize that there are no good, clear treatment options for your child.  

(And let me take a moment to say that when I realized this, I offered up a silent word of thanks that my child was not facing a life-threatening illness, although I am constantly aware of the ways in which Susan's food allergies threaten and limit her life.  As overwhelming as this realization was, even at the time, I knew it could be worse.)

I have always known that Susan's peanut allergy was unusual in it's severity, and that is why I had such high hopes for the PRROTECT study.  I really believed that Susan might truly benefit from oral immunotherapy for peanut supported by Xolair...

And she has.

And yet, as the end of the clinical trial has drawn near, it has become increasingly clear that while Susan benefitted from the use of Xolair to support her desensitization to peanut through oral immunotherapy, we have fallen far short of where I had hoped we might be.

Actually, Susan has fallen far short of the course outlined in the consent for the clinical trial, too.  So, as much as I wish this were just about disappointment and a wish that Susan had gotten to a point where she could tolerate more peanut than she currently does, this is about something bigger -- this is about the question of what happens when a subject does not achieve what is expected during the course of a clinical trial.  This is about the question of what could, what should -- what can safely -- happen once the clinical trial is over.

I have spent hours [actually, I am sure, if you add up all the minutes, all the moments in which Susan's clinical trial experience has crossed my mind, momentarily (or, honestly, longer) distracting me...and all the time I have spent reading research, e-mailing with people, talking to experts, doctors, other parents...the tally is more like days, maybe even weeks]...contemplating the future.

Nearly eighteen months ago, we sat in a room in the Clinical Research Unit (CRU) at Ann & Robert H. Lurie Children's Hospital with a clinical trial coordinator and reviewed the consent for the PRROTECT study.  There was nothing new, as the clinical trial coordinator had provided us with a copy of the consent form prior to our initial visit.  Susan and I went through the consent carefully, as the clinical trial coordinator asked us to review it again there, before signing it.  I read.  Susan read.  Occasionally, we talked.  

Mostly, though, we just read.
There was nothing new -- but there was something...different...about sitting there, reading the consent, knowing that if (when) I signed it, we would be embarking on the first step in what I hoped would be a journey toward greater freedom for Susan.

That something...different...pulled my mind this way and that.

I remember -- ever-so-casually -- asking about something I read...or rather, didn't read.  The consent addressed the 8000 mg peanut challenge at week 31 (which later became a 4000 mg peanut challenge).  What it did not say was what happened to those subjects who failed the challenge.  And sitting there, in the serious space that the CRU is, I found myself thinking about that...turning what felt like an omission over in my mind.  What did happen to those subjects who did not achieve tolerance of 8000 mg of peanut?   The clinical trial coordinator was very reassuring -- explaining that really, every subject should reach "tolerance"...and that it was nothing to worry about.  

I pressed on.  
(Anyone who knows me well knows I always want to know...What if...?)

Well...What if...a subject doesn't achieve tolerance of 8000 mg of peanut protein?

I didn't like the answer, which was that if a subject failed the challenge (at the time it was 8000 mg of peanut protein, but by the time Susan reached Week 31 of the PRROTECT study, the challenge had been reduced to 4000 mg of peanut protein), the subject would not be allowed to continue eating peanut once the clinical trial concluded.

I allowed myself to be assured -- this kind of outcome was not the expectation.  
Perhaps in an exceptional case, the subject would not achieve the desired tolerance, but as the PRROTECT study was specifically designed for children with extremely severe peanut allergies (just like Susan), I allowed myself to believe that Susan would not be one of "those subjects."

I heard the clinical trial coordinator explain that "those subjects" would not be allowed to continue consuming peanut at the conclusion of the clinical trial.

I heard that...and I thought...even if Susan was one of "those subjects"...surely some tolerance would be better than none.  This idea flitted across my mind...unbidden and unwelcome...and I remember pushing it away, choosing to focus on the likelihood of success.  

And while I heard that...I also remember very clearly thinking that there was no way "subjects" who had achieved tolerance of peanut would actually be asked to stop eating it.  I found myself thinking that surely there had to be some middle ground...some way for "those subjects" to be allowed to continue eating peanut.

This idea of a "failure" flitted across my mind...unbidden and unwelcome...and I remember pushing it away, choosing to focus on the likelihood of success.  

The Power of Positive Thinking.
(And all that).

But now that Susan IS "one of those subjects," not a "subject" but a child on the cusp of adolescence (becoming her own person), the reality is stark, and sadly underscores one of many problems with clinical trials involving real people.   

For while there is no protocol that allows Susan to continue eating peanut, how could anyone really ask -- or even expect -- Susan to stop eating peanut at this point?  And even if -- within the protocol and the guidelines of the clinical trial -- there is no space for Susan to continue eating peanut, how could we -- as her parents -- support anything other than Susan's continued consumption of peanut?

We have -- in the last 18 months -- seen Susan safely go to the movies...not once, not twice, but countless times.  We have even allowed her to go to the movies without an adult present.  Susan has started thinking about those ethnic foods she wants to try (the list is long -- with Thai, Indian and Greek topping the list), about flying (Greece is high on her list -- but I'm in for an over-ground-only flight only first!) and about ice cream, donuts...and baked goods.  I said it once, and I will say it before -- Susan is a foodie trapped in a food-allergic child's body.

I have heard that some "subjects" have not wanted to continue eating peanut.
But, Susan, is not a "subject" -- she is my daughter.

And she very much wants to continue eating peanut.

Despite the difficulties Susan has had (or maybe because of them), Susan has never expressed a desire to stop eating peanut.  She has never (even when she was eating the Nutter Butters she found "disgusting") complained about taking her daily dose.

How could we, as Susan's parents, support anything other than Susan's continued Eating (of) Peanut?

While I would much rather take the road more traveled when it comes to anything medical, I started examining roads less traveled.  And while the idea of a road less traveled alarmed me initially, I found myself warming to the idea...

As the end of the clinical trial draws near, the options have became clearer, and it seems like we have three distinct options:

1)  STOP eating peanut.  (Unimaginable to Susan, and, frankly, given what she has gone through, I did not see how we could ever, as parents, take a stance that required her to give up her hard-earned daily peanut dose, despite the risks it seems to carry.)

2)  STAY the course.  Keep at it.  Hope that, with time, Susan's body will come to more "gracefully" accept (read:  tolerate) her daily peanut doses.  While we never actually hammered out the details, with discussion, it became apparent that the doctors involved in the clinical trial would likely support Susan in continuing to eat some amount of peanut on a daily basis.  However, simply keeping at what we have been doing felt a bit like insanity.  If one thing has become clear, it is that Susan does not easily tolerate her daily 2000 mg dose of peanuts.  She has had several epinephrine requiring reactions to her daily dose over the last eight months, and a handful of concerning incidents (where we did not administer epinephrine, but watched ever so closely) -- the single episode of vomiting, the hives, the flushed cheeks and chest...

3)  TRY SOMETHING NEW.  Keep eating peanut, but re-examine things.  I have long felt that Susan barely tolerates (at times) her daily 2000 mg dose of peanut protein.  The random hives and flushed cheeks and single, seemingly random episodes of vomiting are, to me, constant reminders of the edge of the precipice upon which we walk.  I know the researchers believe that this far in, a minute variance in dose should not make a difference in Susan's tolerance of her daily dose, but I also know that Susan's experience is different.  For some reason that is not year clear to us, Susan does not reliably tolerate her daily dose.  As I gathered information and assessed options, I found myself wondering about the medications Susan takes daily (Famotidine, Omeprazole and Zyrtec), and wishing we could add probiotics and maybe even Vitamin D.  

In the weeks that followed Susan's second-to-last clinical trial visit, I reached out to many people -- doctors, researchers, pediatric allergists, parents of children living with food allergies, and friends who have followed our journey from the beginning.  I did more reading than I did before signing the consent for Susan's participation in the clinical trial (and I did A LOT way back then), and a plan started to form.

I am beyond thankful to those who gave of their time, who answered my questions, who helped me think things through.  I especially appreciate those who wear multiple hats -- parents of children with food allergies who are also researchers or allergists...and parents of children with food allergies who are also advocates of research.   Everyone agrees that there is no easy answer.  Everyone supports Susan's desire to keep eating peanut.  One dear, wise friend observed how fortunate we are that we have options, and the wherewithal to pursue them -- even if none of the options seemed quite perfect. 

In the end, we have what feels like a great next step.  We are in unchartered territory -- few "subjects" find themselves in the position Susan will be in at the end of the clinical trial -- with no clear "next step."  While I am sorry that Susan did not achieve the outcome desired in the clinical trial, I am thankful beyond words for the doctors and researchers who have gotten Susan to this point.  We are thankful for all that they did to get Susan to the tolerance of peanut she has achieved, and we are immeasurably optimistic about the future...


  1. We all have benefited immensely from your journey, your meticulous details and most of all, for your honesty. Thank you for all your insights and revelations into a world most of us are not aware of or privy to. Thank for being a much needed window. We have all been in awe of your family love and family strength. We have learned from your journey and Susan's journey. Keep up the great work on all fronts. You are a beacon of light for so many. Louise Larsen

  2. We are doing peanut desensitization with our son and the place where we do it had patients have reactions like you describe until they started recommending the following things. Maybe you have heard of these things but in case not...

    1) Take carbs with the dose. First eat about 1/2 cup safe carbs such as pretzels, then take the dose of peanuts, then immediately drink something (water, juice), then immediately eat another 1/2 cup safe carbs. The carbs slow the absorption of the peanut protein.

    2) Avoid exercise 2 hours after the dose.

    3) Avoid hot showers and hot baths one hour before and two hours after the daily dose.

    #2 and #3 keep the metabolic rate from increasing and affecting how fast the protein is processed by the body.

    4) Take Culturelle (the type of Lactobacillicus GG at 2 billion unit strength) with the daily dose as this has been shown to make desensitization more effective in one study.

    I wouldn't want to stop, either.

    Good luck!