Updosing -- NOT Just Another Day

As the summer draws to a close, the irony of what Susan is going to do today is not lost on me.

On June 30th, 2015 -- after an unplanned one-week delay -- Susan graduated from PRROTECT, a clinical trial that explored the efficacy of Xolair on rapid oral immunotherapy (read:  desensitization) to peanut.  While the clinical trial is still blinded (meaning we can only guess for now), I think everyone involved believes Susan received the placebo initially...

On July 5, 2015, Susan experienced an anaphylactic reaction to her peanut dose.  This was a dose she had been taking since November of 2014, and after eight months, it was a dose she should have tolerated relatively easily.  

Should is a key word, because over the course of the last eight months, Susan has now had three epinephrine-requiring reactions to her daily peanut dose.  

The cause of each of Susan's adverse reactions during the clinical trial (and immediately following) are still uncertain -- we didn't do anything obviously "wrong" (we followed the dosing guidelines and observed the period of rest) and there was never a discernible pattern.  While we will likely never know for certain, I have come to believe that Susan's seemingly random anaphylactic reactions to her dose are the result of a combination of many factors.

And honestly, in many ways, the cause of her anaphylactic reactions doesn't matter, for the bottom line is that they are terrible.

Terrible.
Scary -- every single time -- despite the fact that Susan has had more than her fair share of anaphylactic reactions during her enrollment in PRROTECT.

Life altering.
Can the same thing be life-altering again and again?

I actually think the same thing can be life-altering -- for every time Susan has had an anaphylactic reaction in conjunction with the clinical trial, we have talked about it, shared her experience -- privately and in public.

While I will never know for certain, I believe our openness has helped others understand the importance of early administration of epinephrine.  If even one parent or caregiver does not delay in administering (or supporting self-administration of) epinephrine, Susan's experiences have been life-altering.

And, as Susan's mother, I now feel more certain than I ever would have that Susan will self-administer epinephrine should she need it.

Let me be clear -- there is still that niggling voice in the back of my head that wonders if Susan would really whip out her EpiPen in the middle of her English Literacy class and ever-so-calmly (or not) jab herself in the thigh with it, counting to ten while her teacher called the nurse and the nurse called 911...and hopefully in the chaos of it all someone remembered to call me...

But, after the last 18 months, I have more confidence that Susan would (successfully) self-administer epinephrine than I ever had before.

And -- that's life-altering.
For Susan.
For me...
   for my husband -- for our family.

I now believe in the possibility of college, and travel, and a much more "normal" future than I ever envisioned for Susan.  I don't know if Susan will ever travel to compete, but I no longer believe her peanut allergy will hold her back.

It has absolutely, positively without a doubt been more difficult to get to this point than I ever imagined, but I wouldn't do it any differently -- for as crazy as it might sound, every single anaphylactic reaction brought us one step closer to where we are now.

While I wouldn't suggest our course for anyone, as with anything in life, I honestly believe that, at least for Susan, practice has made more perfect.  (That said, even during her last anaphylactic reaction, Susan didn't self-administer perfectly, but she got the medicine in...and that's what matters.)


Susan's first appointment with her private allergist, Dr. Bajowala, was scheduled for July 6, 2015 -- one convenient day after Susan's anaphylactic reaction to her dose (which she had me record so that she could make a short video about the importance of prompt administration of epinephrine as part of her Girl Scout Silver Award).  

I still remember that day -- sunny, hot and humid -- a true Chicago summer day...followed by a violent thunderstorm which resulted in a twenty degree drop in temperatures across the Midwest.  Even with the crazy weather, it still felt "early" in the summer to me.

Dr. Bajowala decreased Susan's daily peanut dose, from 2000 mg of peanut protein to 1500 mg of peanut protein.  (Actually she decreased her dose from 2000 mg of peanut protein to 3000 mg of pure peanut, but that's...confusing, to say the least.)  She also changed the timing of Susan's daily Zyrtec and added probiotics, Vitamin D and Cranberry Powder -- and instructed Susan to take her dose with applesauce every single time.  Our consumption of GoGoSqueeZes has gone through the roof!  

Over the course of the summer, Dr. Bajowala slowly weaned Susan off the Omeprazole she took for most of the clinical trial and increased Susan's peanut dose from 3000 mg of pure peanut to 3500 mg of pure peanut to 4000 mg of pure peanut -- a move that returned Susan squarely to where she was when the clinical trial ended.  I was out of town with our son for those two appointments, so my husband took Susan.  We have a few photos, but don't expect blog posts from those!

I cannot help but reflect that the summer has been easy...neither updose was of particular concern to me, as Susan had tolerated each of her doses without issue -- gone, even, is the hivey, angry looking skin Susan sometimes contends with.  

I have a friend who counts days (she's impressively good at it, actually...although I have sometimes wondered if she uses some sort of on-line date calculator or something).  I'm purposefully NOT counting days at this point, but I'm really pretty certain that Susan has now gone longer without an adverse reaction to a dose in...well, a very long time.  Let's just say a lot of days.  I'm pretty sure, in fact, that if one were to do the math (which I am NOT going to do, because I'm sometimes sort of superstitious like that), this is the LONGEST Susan has gone without an adverse reaction to her dose since...well, a very long time.


And now, here we are -- about to do something I once doubted would ever happen.  Today, Susan is going to updose to 4500 mg of pure peanut, or 2250 mg of peanut protein.  That's MORE than her daily dose for more than eight months of PRROTECT.  That's more than Susan has ever eaten in a single dose (even the day of the 4000 mg peanut protein challenge during PRROTECT, which did NOT go well, her biggest dose was not that much).

Oddly, I'm a little nervous, but I'm not really scared about this updose.  
(Although really, if I have learned anything from our journey in the clinical trial, I probably should be concerned, for if I did not know it before, I certainly do know now that nothing in life is certain.)

THIS updose is the beginning of the future.

If my theory is right, that the medications Susan was taking in an effort to stabilize her and allow her to tolerate her daily peanut doses in the clinical trial, were interfering with her ability to absorb and digest her peanut doses...

If my theory is right, that the addition of probiotics, Cranberry Powder and Vitamin D to Susan's daily diet have improved the functioning of her immune system...

If the prevailing theory in OIT is right, that when a subject is struggling to tolerate a dose, decreased dosing for a short period of time often enables the subject to resume dosing and move forward to an even higher dose without issue...

Today should go well.
Right?

Video of Susan Self-Administering Epineprhine

On Sunday, July 5, 2015, Susan had an anaphylactic reaction.

I recorded her self-administering epinephrine.
What she did next has the power to save lives.

Semantics

A peanut is a peanut, right?

For most of Susan's life, anything peanut spelled D-A-N-G-E-R.

But now, as Susan moves from participant in clinical trial to private oral immunotherapy patient, it seems not all peanuts are the same.

There is peanut protein...and pure peanut.

On Sunday morning, before her anaphylactic reaction, Susan took what was (and had been for more than eight months), her daily peanut dose in the form of a single Reese's Peanut Butter Cup (she's been taking her dose in the form of a single Reese's Peanut Butter Cup for more than two months).  Susan's dose contained the equivalent of 2000 mg of peanut protein, or about 8 1/2 peanuts.

After her anaphylactic reaction, Dr. Bajowala recommended that we decrease Susan's dose to 3000 mg of pure peanut.  (That's pure peanut.)

Wait.
That sounds like an increase -- especially in this fast-paced world we live in.

In fact, even the doctor now following Susan from PRROTECT was confused.  In response to my e-mail outlining Susan's anaphylactic reaction to her dose and the plan for going forward, she wrote, "You said you decreased to 3000 mg; I thought she was on 2000 mg?"

I get it.
It was confusing to me, too.
Susan's 3000 mg pure peanut dose IS a decrease.

Here's the translation:
1 peanut = approximately 500 mg of pure peanut
1 peanut = approximately 250 mg of peanut protein

So...Susan's current dose SHOULD be about 6 peanuts.

However, while anything peanut has always spelled D-A-N-G-E-R to us, it seems not all peanuts are the same.
There are peanuts, then there are giant fancy peanuts...and then there are runner peanuts.
Huh.
(I'm sure there are all sorts of other peanuts out there, and I mean no disrespect to those types of peanuts I have left off the list -- I just haven't met them yet.)

I hadn't ever really looked closely, but it seems that peanuts really do come in all shapes and sizes.

This morning, Susan's dose -- 3.0 grams according to my scale (which is really a possible range of 2995 to 3004.9 milligrams) -- consisted of 2 whole peanuts and almost all of a half of a peanut.

It doesn't look like much, does it?

(I keep reminding myself that there was a time when Susan experienced anaphylaxis with peanut particles floating around in the air...so while her current dose doesn't look like much, it IS progress.)

But...what happened to the six peanuts Susan was tolerating?
Well...they must not have been very big peanuts.

In time, according to Dr. Bajowala, we won't need to weigh Susan's dose -- she'll just count peanut halves.  I trust Dr. Bajowala, but having a new and improved understanding of all the different sizes and shapes a peanut can come in has given me a new-found appreciation of my scale.

While what we are doing is similar in that Susan is continuing to do oral immunotherapy, we are in a new land...and in this new land, there is a new language of sorts.  

In the end, I think it is just really all about semantics.

Confirmation

I am a worrier.
A thinker.
(As a small child, I would get up multiple times after my parents tucked me in for the night -- I always had earth shatteringly important questions that just could not wait for the morning.  Now, as a working mother of three busy children, I fall into bed exhausted most nights -- too tired for such wandering of the mind...)

I'm not anxious, but, sometimes, when I make a decision -- especially a big, important decision -- I revisit the decision...turning it over in my mind, re-examining the decision, the various factors, all the angles -- wondering if the decision I have made (whatever it is) was truly the right decision.


I haven't felt that way about our decision to seek post-clinical trial care in the form of private oral immunotherapy to peanut for Susan from Dr. Sakina Bajowala.

I really, truly have not felt the need to revisit that decision -- at any point.

It was one of those decisions that came easily (well, easily once I had done my research -- reading everything I could find about oral immunotherapy and talking to all the parents, allergists, and researchers who so kindly gave me their time and wisdom).  

The decision came easily because it seemed as certain as possible that with Dr. Bajowal'a guidance, we might be able to achieve our goals for Susan's long-term consumption of peanut (to continue, and, eventually...hopefully, increase her tolerance beyond what appeared to be a justbarelyandnotalways tolerance).  

While reaching a decision was time consuming, once the decision was made, I never looked back.

In fact, I have been excitedly awaiting Susan's first appointment with Dr. Bajowala (tomorrow!)...


And so today, when Susan had an anaphylactic reaction to her single Reese's Peanut Butter Cup, even though I have never once second-guessed this particular decision, I found myself thinking that if I had ever felt the need for confirmation of the decision, her reaction to her dose today did it.

Susan had homemade muffins (a staple in our house, and no new ingredients), melon (one that she eats regularly -- and that she had had the previous day), yogurt (a brand and flavor she adores and eats almost daily), and milk -- from a carton she drank out of yesterday for breakfast.  After breakfast, she took her Zyrtec, Omeprazole and Famotidine and then ate her single Reese's Peanut Butter Cup.  She finished at about 9:15 am.  

About twenty minutes later, after hanging out with me and Sophia, our cat that chose Susan as "hers" about five years ago, Susan and my younger daughter asked if they could go outside, to sit on our oversized chaise lounge and read.  

When I suggested an oversized chaise lounge to our landscape architect, wanting to be sure our patio would have enough space, I know she could hardly believe that I was asking that the size and shape of our patio be configured around a piece of furniture, but I knew -- long before we even had it -- that our big green chaise lounge would be a highlight in my life -- and I was right.  I love it as much this summer as I loved it the summer it was delivered...eight years ago.

Susan loves it, too.
And so do Meg, and Carl.

I wondered about sitting outside post-dose, and even voiced a concern to Susan.  She hesitated, and so did I.  And then, after looking out the window and realizing that the chaise lounge was in the shade, I agreed that they could go.  I kept an eye on them, and the chair, and about 30 minutes later, went out to see if they wanted anything.  They declined my offer of popsicles (I was surprised, because in my mind it was such a treat -- popsicles before noon! -- but it really wasn't that warm...between the shade and the breeze from the lake, so I understood).

I noticed that the sun was starting to peek onto the chair, and we agreed that we would keep track of it.  

I went back inside and started to do some work.

I was shocked when Susan and Meg came in about 10 minutes later.  Susan's face was bright red -- like it has been in previous reactions -- and she said her breathing felt a little "tight."

She sat down, and started pulling her EpiPen out of her purse while Meg ran upstairs to get her lovie, Ga (a chocolate brown teddy bear that she has spent all but one night of her life with since she adopted him -- paw first -- from a giant wicker basket of similar bears on Father's Day weekend when she was ten months old) and her baby blanket.  

With surprise, she said "Oh, I feel better!"  
I was surprised, too, so I started checking her skin and assessing for other symptoms.
  (I didn't like what I saw -- that same hivey rash we have become accustomed to over the last year.)

And then, seconds later, she said, "Oh, no, I'm not really better." 
As she said it, I heard the wheezy tightness that made me absolutely certain Susan was experiencing an anaphylactic reaction.

We both knew she needed epinephrine, and we didn't even discuss who would administer it.

Susan's experience in PRROTECT has given her many things -- and while I think the clinical trial will become a stepping stone on Susan's path to true freedom from peanut, the most tangible thing her experience in the clinical trial has given her at this point is experience in self-administering her epinephrine...and with that comes the absolute certainty that she KNOWS what to do.

I knew it already, but I saw it in black and white on Tuesday, when Susan completed the last survey for the clinical trial.

She reported believing that there is a very small chance she will die if she eats something she is allergic to (the survey asked about "accidental" consumption, but I think her daily dose applies) and reported a 0% chance that she will not know what the right thing to do is if she has an anaphylactic reaction.  Knowledge is power, for sure.


This morning, as Susan readied herself, preparing to self-inject her epinephrine, I did something different than I usually do.  I did not sit with her, assuring and encouraging her.  This time, I readied the video camera on my phone.  While my hands were shaking, I was absolutely determined to mirror Susan's calm.  

After Susan self-administered her epinephrine last time, she decided she wanted to make some sort of video or PSA for tweens and teenagers living with food allergies for her Girl Scout Silver Award project.  She wants to share her first-hand experience in administration of epinephrine with others, believing (as do I) that what she knows has the power to save lives.  And so, we had agreed that if she required epinephrine again, we would try to record her self-administering her epinephrine.  (Susan says she is going to hope for 5,000 views.  I think she is going to be shocked by how many people want to see what she plans to offer...)  

I held my phone the wrong way, and Susan is not in focus 100% of the time...and there is a bit missing when Susan pulled her arm back (out of the frame) as she prepared to self-inject...but even with all of that, it is a pretty powerful piece of video.  

Susan was incredible.
She was calm, and collected...and while I am so so ready to share her video now, this is not my project...and so it is not mine to share.
But let me just say -- Susan was incredible.

The video captures Susan mentally preparing to self-inject, self-injecting, her immediate reaction and the rapid relief she felt...and then her talking just a bit about what was going on for her.  

Susan in her soft PJ pants, a t-shirt and her hair is pulled back in a scraggly bun.
IT IS SO REAL.


After, Susan was shaking...from the epinephrine...and then exhausted from the Benadryl (which she took after self-administering the epinephrine).
And I was shaking...from the adrenaline...and, frankly, exhausted from...everything.

I made contact with Dr. Bajowala.
We made a plan.
Instead of reducing Susan's peanut dose to 3000 mg of peanut (approximately 6 peanuts) tomorrow, during our scheduled visit, she asked that we reduce Susan's dose for tomorrow morning.

My husband, Paul, bought peanuts.
A whole can of them, at Costco.
The can reads:  "Super Extra Large Peanuts" and carries a cross-contamination warning for dairy (thankfully, so not an issue in this cheese and yogurt loving household!).

He texted:  "I can't believe I am buying peanuts."
Right there with you.

We sorted out a new (and stubborn) medical scale that SHOULD have calibrated easily but never did after the pharmacist at Walgreen's refused to weigh her dose (liability) and a Facebook plea for a medical grade scale we could borrow came up empty.  (Our scale measures to .00 of a gram, so there was a bit of room for error...which we addressed.)

Carl and I played with peanut "wholes" and peanut "halves" and peanut bits.  We decided it was a bit like playing Tetris (a game I am decidedly good at, fortunately).  We arrived at this as the proposed dose:
  

(That's 2 whole peanuts, 1/2 of a peanut and a "peanut part.  Really -- mind-bogglingly not a lot...)

I sent a picture of the proposed dose by text to Dr. Bajowala, explaining the limitations of our scale and initially describing the dose as 300x (x = ?) mg of peanuts.  Later, a very bright Grinnellian pointed out that actually, it "could be anywhere between 3004.9 mg and 2995 mg.  Probably not significant."  I replied that one never knew in peanut-eating land, to which he replied it was fortunate that we had a doctor whose advice we could rely on.  With gratitude for all of the doctors who are collaborating on Susan's care, I replied, "or 4!"


Susan hung out all day, reading, watching movies, playing video games.
She was in bed, asleep for the night, before 6:00 pm.
We haven't left her alone, and won't.


Once again, the cause of Susan's reaction is not known.  Maybe the sun and heat, but it really wasn't very hot, and while she DID end up in the sun, it was for a very brief period of time.  I don't believe this particular adverse reaction could be related to a discrepancy in dose (Reese's Peanut Butter Cups appear to be fairly uniform), to puberty or to her fledgling cycle...and other than the fact that she got braces on Thursday, there really isn't anything new.

A dear friend said it well...after we discussed the possible causes for Susan's reaction without arriving at any real answer, I reminded her that Susan has new (as of Thursday) braces.  To which she replied:
"Which is such a crazy variable but I will believe anything at this point."
Right.
Me too.

Which is why I am thankful beyond words that we are where we are in terms of a care plan going forward...

I don't think I will ever get to the point that I take an anaphylactic reaction in stride, but I honestly believe that I am more confident in Susan's ability to take care of herself now than I was eighteen months ago, before her first reaction the night of the food challenges that resulted in her being offered enrollment in the clinical trial.

I had a friend wonder aloud today why we would continue this course.
The answer is simple.
Because I want Susan to live a freer life.
And so does she.

And while her journey might be harder than most, isn't freedom worth fighting for?

Freedom

Over the last eighteen months, I have become somewhat active in a number of different food allergy Facebook groups.  I joke that I am both an accidental blogger and an accidental "Facebooker" -- but the truth is that it is true.  Two years ago, I barely knew how to sign into my Facebook account, and I followed exactly...one blog.

Today there have been several posts on the various Facebook groups regarding food allergies and freedom.  

Those posts got me thinking...about Susan, about the freedom we have as Susan's parents to pursue the care we think is in her best interest...and about Susan's on-going quest for greater freedom from her peanut allergy...


In June, I wrote to the doctors running PRROTECT [Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial (supported with Xolair)]:  "While Susan appreciates the freedoms she is likely to have as the result of the clinical trial (she has already, for example, been to several movies in the theater and we are talking about taking a short flight), she wants greater freedom."

That's right.
Greater freedom.

And she's willing to do whatever it takes -- including eating a daily dose of peanut that her body does not always tolerate very well.


During Susan's enrollment in the clinical trial, I often had people question our decision to allow Susan to stay in the clinical trial -- especially as the number of anaphylactic reactions she experienced grew.

In a blog post in January, I wrote:  "I have lost friends who do not -- simply cannot or will not -- ever understand or accept our decision to pursue treatment for Susan through a clinical trial...and I have gained a community of people who -- like me -- are searching for a safer passage for their children.  (I have come to understand the value of true friends, and am beyond thankful for those in our circle who have supported us even if they may not fully understand or agree with our decision...)"

In the months since then, I have continued to be asked to defend our decisions to those who do not see it clearly themselves...and I always find myself explaining that we have allowed Susan to guide us in the decision making -- and she has aways, without fail, even immediately following an anaphylactic reaction to her dose, wanted to see this course of treatment through.  I have found myself explaining that it must be more awful to live with life-threatening food allergies than I can even possibly imagine, for Susan to willingly put herself on the line (I will not say at risk, for I have come to know with certainty that one thing Susan has gained from this clinical trial is confidence...the knowledge that she absolutely knows what to do in an emergency) every single day.

And then, earlier this week, on the last day of the clinical trial, I got to see it for myself, in black and white.  

[Since the clinical trial began, every so often we have been asked to complete repeat surveys regarding Susan's peanut allergy and it's effect on the overall quality of her life.  Susan, my husband, and I each complete our own, independently.  Once, I "oversaw" some of Susan's answers, and as I wrote in January, I felt terrible about the fact that I accidentally saw Susan's completed survey...and even worse about what I accidentally learned.  "My strong, kind, compassionate and brave Susan is saddened and [very] troubled every time she is different, left out...restricted...limited.  And because she is the kind of person she is, she hides it."]

During our last clinical trial visit, we were asked to complete the same survey -- for the last time.  This time, I asked for -- and received -- Susan's permission to look at her answers.  I was prepared to let her look at mine if she asked, but...she didn't.  I put my social worker hat on and talked about it with her as I looked at it...and with her permission, I photographed it, knowing that some day, I would write about it in its entirety.

Toward the bottom of the second page of the three-page survey, I saw -- in a single question -- the reason behind Susan's determination to fight her on-going personal war against peanuts.  On a 6-point scale, with 6 being the worst, Susan reported a 5 ("very") in response to how disappointed she is that she has a peanut allergy.

I can say with confidence that our country's freedom came as the result of leaders with vision, commitment and determination fighting a series of long, hard and (I am sure) sometimes frightening battles.  Freedom did not come easily for our country, and freedom from Susan's peanut allergy is clearly not going to come easily to her.  But that does not mean it is not worth the fight.

Susan does not have the freedoms most of us living in this country have -- she cannot sit where she wants in the school lunchroom, she cannot just go out to eat, she cannot make spur of the moment plans, until recently she NEVER went to the movies, she cannot...live without thinking about countless things:  the risk of exposure to peanut, what she will eat when, and whether or not she is making safe choices.  We do not fly (an emergency landing after Susan experienced anaphylaxis from airborne exposure to peanut permanently "grounded" Susan), and we rarely travel -- and when we do, it is with countless extra precautions, special cleaning requests, a pre-determined list of very safe restaurants (Chipotle and Qdoba top the list)...and a cooler of food.  Susan cannot go anywhere without emergency medication -- which she carries in her purse...and which she wears at all times...even in our own home.  

Today, I am thankful we live in a country where we, as Susan's parents, have the freedom to seek the treatment we believe is in her best interest.

And, today, as I sit here writing this, I truly believe that some day, Susan will have her own personal "Independence Day."  I am confident that what it takes to achieve such independence makes the victory all that much sweeter, and I am committed to standing by Susan, supporting her however I can, as she continues to fight her own personal war against peanuts...moving from clinical trial to private OIT (oral immunotherapy).

Susan's journey toward freedom from her peanut allergy has not been fast, nor has it been easy.  But, isn't anything this potentially life-changing worth fighting for?

What I Wrote (or My Missive)

Dear Dr. P., Dr. M., Dr. R., & Dr. Bajowala,

We are writing to you because we are hoping you will agree to something we know is highly unusual.  We would like one of the doctors from PRROTECT to co-follow Susan during her post-clinical trial care with Dr. Bajowala.  I raised this concept previously, but wanted to write directly to explain why it is important to us.

While our most compelling reasons for wanting Susan to be co-followed by one of the doctors from PRROTECT and Dr. Bajowala once the clinical trial is over do not pertain directly to her, we do believe it would be in Susan’s best interest – as a patient and as a child.  Continuity of care and maintenance of the relationships Susan developed with doctors during the clinical trial is important for Susan, as she has consistently demonstrated a strong commitment to research in the food allergy field.  If she is co-followed, Susan will experience that same commitment from the doctors who have overseen the clinical trial since the beginning while undergoing the more specialized treatment options we are hoping Dr. Bajowala can offer.  As Susan’s mother, I feel strongly that it is important that she feels supported in her post-clinical trial care plan, even if it is unusual.

In the past eighteen months, I have come to understand that there is a long-standing history of subtle (or maybe, in some cases, not-so-subtle) tension between pediatric allergists in the field of food allergy research/clinical trials and pediatric allergists offering treatment for food allergies in private practice.  I have also learned there are many people within the food allergy community who believe there is only one “right” way to address the growing food allergy crisis.  Susan’s experience in the clinical trial over the last eighteen months has underscored what we already believed to be true:  the “new” real world allergy patient is unique.  Every patient needs something different, and for many of those patients, a truly meaningful, quality-of-life-improving treatment is only likely to be achieved with the wisdom of more than one doctor. 

If Dr. Bajowala and a doctor from PRROTECT work together to treat Susan once she finishes the clinical trial, it will send a powerful message to the food allergy community that ultimately the “food allergy cure” is not the same for every patient.  While I am an accidental blogger, I have come to understand the importance of sharing Susan’s story, as people everywhere need to understand the realities of these early food-allergy treatment efforts.  Many people in the food allergy community have followed Susan’s journey, and are waiting to see what happens next.  Working together, we could become an incredible example.

Working together to find the very best treatment approach for Susan would be a significant and remarkable leadership step, as co-following Susan would demonstrate the possibility of forging a very important relationship between those who do research and those who implement in practice the research that has been done.  We also believe that for those parents who hesitate to allow their child to participate in a clinical trial because they worry about post-clinical trial care, demonstrating clearly this type of post-clinical trial commitment is very important, and feel that it might make participation in clinical trials more appealing.  We also believe that if both doctors work together, the formation of such a treatment team for Susan would directly challenge the belief held by some parents of children with food allergies that researchers are not invested in the long-term well-being of their subjects.  (While I do not believe this to be true, I have heard it often enough to know there is a significant percentage of the population that does).

In addition to the benefits Susan would derive from being co-followed, and the benefits to the food allergy community as a whole, the doctor from PRROTECT and Dr. Bajowala would likely derive benefits for their own practices.  As a social worker, I firmly believe that I can always learn from other skilled clinicians, and I believe the same is true in the medical field.  We are confident that if you agree to work together, and to co-follow Susan, you will both benefit from exchange of information you can use to inform your own practices.

We think everyone involved will agree that Susan did not respond to the treatment provided in the clinical trial as anticipated.  While there are a number of theories as to why Susan did not respond as anticipated, we do not yet understand why she did not achieve the desired tolerance of peanut protein.  We believe that under Dr. Bajowala’s care, with treatment tailored specifically to Susan, we are likely to gain a better understanding of why Susan struggled to achieve the desired tolerance of peanut protein.  While we know Susan falls outside the “norm” in terms of her response to the treatment provided in the clinical trial, we are increasingly certain that Susan is not the only child who has not responded as expected in a clinical trial.  Children like Susan, who do not respond as anticipated are of tremendous concern for us, for the key to their food allergy treatment is clearly not yet fully understood.  We are hopeful that Susan’s response to an individually tailored treatment plan with Dr. Bajowala will provide insights that will be beneficial in the treatment of other children like her, and we expect that treatment implications generalizable to others like Susan will emerge.

We see the unexpected week in which Susan is still in the clinical trial as an opportunity to work out whatever details we need to in order for this to work for everyone, including a communication plan and method for sharing of medical records.  When we met with Dr. Bajowala in early June, she was already somewhat familiar with Susan’s experiences in the clinical trial.  Dr. Bajowala also reviewed Susan’s course in the clinical trial with us in great detail.  She was highly complimentary of the PRROTECT doctors’ efforts to keep Susan in the clinical trial by addressing symptoms during Susan’s early dosing with medication.  She noted how committed everyone was to Susan despite Susan’s difficulties during the clinical trial, and Dr. Bajowala agreed with the concern we think we all share, which is that Susan does not consistently and reliably tolerate her daily peanut dose. 

While I invite you to talk with Dr. Bajowala directly (and I will sign whatever release or consent needed), I feel that I can accurately summarize her initial treatment plan.  She recommended reducing Susan’s daily peanut dose, adding probiotics and Vitamin D and slowly weaning Susan off of the Omeprazole and then the Famotidine.  Dr. Bajowala expressed her belief that with time, Susan could increase her daily peanut dose, but we agreed to address increased peanut dosing once we see how Susan does with the initial treatment plan.  I believe that a reduction in Susan’s daily peanut dose is a recommendation everyone will be comfortable with.

Once Susan, Paul and I met with Dr. Bajowala, our decision to ask Dr. Bajowala to treat Susan after the clinical trial was easy, because she has extensive experience with oral immunotherapy and she had some concrete ideas about how to improve Susan’s tolerance of her daily peanut dose.  While the best choice for Susan was clear, it was a hard decision to make, because we do not want to lose our relationship with the doctors from PRROTECT, and we never want anyone to feel that we think treatment in a private practice setting is preferable to participation in a clinical trial.  While the best course for Susan was clear, concerns about how our decision would be viewed by others – and about the message it might send to the food allergy community – gave us pause.  When I explained to Susan yesterday that I intended to write this letter, asking Dr. Bajowala and a doctor from PRROTECT to co-follow her, she was really pleased.  I asked her what I should say, and she summed it up well: “I think this would be a great learning opportunity for everyone.”

We think we understand the significance of what we are asking, and we thank you for your consideration of our request.  Should you agree to work together, we promise to do all that we can to make the collaboration easy, and if for some reason co-following Susan does not work, we will chose a single doctor promptly.  We are deeply hopeful that we can find a way to make it work for both Dr. Bajowala and one of the PRROTECT doctors to co-follow Susan.  While we know our request is unusual, we believe we all want the same thing – fewer children living with the risks and limitations imposed by food allergies.  Thank you so much for all you have done already – and for all we hope you will be able to do—for Susan, and for countless others like her.

Sincerely,

Caryn, Paul & Susan 

The True Meaning of Graduation

What is supposed to be Susan's last clinical trial appointment is in a few hours.

I slept poorly last night, largely due, I am sure, to the new information that was swirling around in my mind.

The clinical trial coordinator called me late yesterday afternoon.  She was calling to check to see how Susan had been tolerating her daily peanut dose since we started holding her Zyrtec (her last dose was early Thursday morning), and to see if we had any questions about the upcoming visit.

She was pleased (and pleasantly surprised, just a little, I think), to hear that Susan had been tolerating her dose well.  (When I reported that, it was before Susan took her shower...and before the return of the light, hivey rash we have become familiar with over the last year.)

I took the opportunity to ask some questions about Susan's post-clinical trial care plan -- planning I am certain I have complicated in announcing our plan to seek private OIT treatment for Susan with Dr. Sakina Bajowala coupled with the request that one of the PRROTECT doctors co-follow Susan once she is discharged from the clinical trial.      

As an aside, let me say that I think maybe, just maybe, this is where the idea of making meaning out of the senseless things that happen in this world comes in, for I know asking that a doctor from PRROTECT co-follow Susan with Dr. Bajowala could only be good...for Susan, for research, for anyone and everyone hoping for truly life-changing treatments for those living with food allergies.  And yet, I also know that in asking for this, we are making a highly unusual request.  I wrote a missive on this topic last Thursday to all of the doctors involved...and when (and if) appropriate, I will share it.  

Basically, I explained why it was important to have our (peanut butter) cake and eat it, too.

In response to my missive, I learned that there is likely to be a 5-year follow-up study -- different from the one that did not get funded (Susan would not have qualified for that one, for all subjects had to achieve tolerance of 4000 mg of peanut).  While it was really disappointing to us from a greater-good perspective that the original follow-up study was not funded, the one that has been proposed is likely to work out better for Susan.

There is far, far more that I do not know than what I do know.

And...
While at this point there are far, far more questions than answers, it seems like we just might...maybe, actually get to have our (peanut butter) cake and eat it, too.

While the protocol for the follow-up study is still being finalized, and they need IRB (Institutional Review Board) approval, the clinical trial coordinator was able to provide me with an overview.

In some ways, the follow-up study, which will consist of a single visit each year, will be significantly more flexible than the clinical trial.  The clinical trial coordinator explained that in the follow-up study, there is likely to be more flexibility, allowing for the occasional skipped dose and fewer post-dosing activity restrictions.  Since Susan's goal is to pursue greater tolerance of peanut, skipping of doses is irrelevant to us, and given that her tolerance of her daily dose is not reliable, I cannot see decreasing her activity restriction.

I did have one pressing question...the single issue that I knew might be a deal-breaker for Susan.  

The question was this:  "What is the plan in terms of dietary restrictions?"  The clinical trial coordinator was not sure, but she was able to tell me that...at least as of right now...the discharge instructions remain the same as they have been during the course of the clinical trial:  NO NEW FOODS.

I pressed her, knowing that while Susan has never been in this for the ice cream or bakery treat, she has (honestly, we all have) been looking forward to greater freedom when it comes to eating out.

The clinical trial coordinator acknowledged that one of the goals of the clinical trial is to afford subjects greater freedom when it comes to doing things like eating out, and trying new foods...but, she was unable to provide a clear answer on the question of dietary restrictions.  

And so I asked more directly:
"Will subjects in the follow-up study be asked to adhere to the no new foods restriction that they have been following during PRROTECT?"

The clinical trial coordinator did not know, and while I appreciated her honesty, I was also stunned that this piece remains uncertain.  

I had a few hours to process the information I learned during my conversation with the clinical trial coordinator before I saw Susan, who spent the day at the rink.  I am glad I had some time to process what I had learned, for I was able to present what I did know clearly, and definitively...even though much of what I was presenting to Susan was, in fact, uncertain.

I hesitated when I got to the piece about the dietary restrictions...(knowing full well that I still had a group of Susan's friends cued up to surprise her at Baskin Robbins tonight, thinking that I should probably call the outing off...yet waiting, wanting to hear that these restrictions must remain in place directly from the doctor).  I explained to Susan that, according to the clinical trial coordinator, at least as of right now (and for an indeterminate amount of time going forward), she is likely to have to observe the "no new foods restriction."


Susan took it all in, no questions.
And then she said, "I can do that.  I want to do the follow-up study."

I was simultaneously thrilled, for I believe Susan's choice is right when it comes to the science of things...

And taken aback...

For what if she is asked to observe the "no new foods" restriction for the duration of the follow-up study?  (I don't know if she will be, but I also do not know that she will not be...)
She will be a SENIOR in HIGH SCHOOL in five years.
Unfathomable, really -- to imagine the rest of Susan's childhood in a clinical trial follow-up...still living with her current dietary restrictions.


And so I asked some questions -- mostly wanting to be sure Susan understood what she was saying, and reminding her that, since the follow-up study protocol is not yet complete, she has some time to think about it (we will not be presented with consents today because they are not yet ready).

And yet, Susan remained clear.  She wants to do the follow-up study.  And she doesn't care what that means in terms of restrictions, "Because it is important, Mom."

And besides, she added..."It isn't any different than what we already do."

My heart catches and my breath hitches when I think about what continuing to follow the "no new foods" dietary restriction means...for Susan, for our family.  

I feel conflicted (even after a night of tossing and turning) about Susan's clinical trial graduation gift -- a card tucked into an envelope with a host of $5 gift cards for ice cream and baked goods...and candies we have only ever looked at -- Snow Caps (my childhood favorite) and the new Hershey's chocolate covered caramels...

What do I do with that gift?
Give it?
Hold it?
Disassemble it, using the gift cards on Susan's siblings when she is not present?
A long night later, I still have not decided.  

I am going to take Susan's gift with us when we head downtown to Ann & Robert H. Lurie Children's Hospital later today.  I think I am going to leave it in the car...for I am not sure what I am going to do with it.

I am thankful I also tucked a bracelet into that gift bag...one with meaning, for no matter what happens, I can give her the bracelet.


Hours later, I haven't figured out how I feel about where we are now.  (Well, some things I know...I am beyond thankful that there is likely to be a follow-up study...which I think is important for Susan, for the other children who are finishing PRROTECT at Ann & Robert H. Lurie Children's Hospital...and for the future of food allergy research and treatment.)


But more than anything...
This is where I step back and marvel at Susan.
For it is clear to me that, at least in her case, if she enrolls in the follow-up study, it will not be about Susan.  Enrollment in the follow-up study will be all about the greater good.  

And incredibly, Susan wants to participate in the follow-up study -- even with the uncertainties about dietary restriction...even if, as I put it, worst case, she has to follow the "no new foods" restriction for the next five years.  

"Because it is important, Mom."


And so, on the morning of Susan's graduation from the clinical trial, I am struck by the fact that her future is as uncertain as many graduates' futures are on their graduation day.  Uncertain as the future is however, I am certain Susan has grown from her experiences, and that she is in a better place now than she was eighteen months ago.