Photo by Rebecca Gould Photography

Wednesday, May 21, 2014

250 is Just a Number.

As is 30.
And 180.
And lots of numbers in between.

Today was a big day in clinical trial land.  And, for those of you who are keeping track, this is Week 12.  (This actually matters later, it turns out -- quite a bit, in fact.)  

The drive in was torture.  It took us 2 hours and 27 minutes.  Even my smart new navi could not find us a good route.  I was nervous.  Susan was not -- at least not that she was admitting.  She snuggled into the back seat with her lovie (Ga), her baby blankie (they sort of go together) and her pillow.  She played games on her phone and read...and while she was not talking about it, I knew -- by the very fact that Ga and baby blankie were along for the ride, that some part of her was...uncertain...

The clinical trial visit began as usual -- height, weight, vitals, etc.  But, there were some differences in the way the room was set up for this visit.  I immediately saw (and was reassured by) the presence of the black and red emergency bag.  I also noticed some of those hospital basins -- I don't know what all they are used for, but, vomit was the first thing that came to my mind.  I averted my eyes.  Remember -- I DON'T DO vomit.  I also saw stacks of towels, and a blanket...and a large paper bag with a prescription label on it...and several containers of chocolate pudding (Susan's choice).

The nurses on the Clinical Research Unit helped Susan get comfortable in a reclining chair.  They inserted an IV using the pop-top fizzy device, which Susan prefers (they remembered this -- they are so awesome!), drew blood, placed the blood pressure cuff and after a bit of a discussion which revealed that Susan was unwilling to give up use of any of her fingers (for the pulse ox), they suggested using a toe.  As toes aren't required for the playing of Fruit Ninja, this was a perfectly acceptable plan.

Before beginning, the clinical trial coordinator checked -- did we have Susan's Epi-Pens with us.  OF COURSE.  Was I so thankful she checked -- ABSOLUTELY.  Did I have a moment of thinking -- She's not supposed to get sick today?  Yes.  Yes, I did.

Today, after having a total of 18 injections over the last twelve weeks, Susan was presented with 250 mg of peanut protein (in 10 incrementally increasing doses).  The goal was that she would be able to tolerate consumption of the entire 250 mg of peanut protein without having a reaction.  That's ONE WHOLE PEANUT.  To put this in perspective, Susan began showing significant signs of a reaction after consuming half of a dose of 25 mg of peanut protein during the food challenge at the outset of this clinical trial (One Day, Two Food Challenges).

Just for fun, we stacked them into a haphazard tower.  

If you look carefully, you will see that they are very clearly labeled, with the dose number and the amount of peanut protein therein.  While we stacked them randomly, there was NOTHING random about the dosing for the day -- each of those bottles held a very carefully measured dose of peanut protein which was suspended in a flour, the entirety of which was mixed into chocolate pudding.  

As the clinical trial coordinator mixed the first dose of peanut protein into the chocolate pudding, she began talking to me about the specifics of home dosing, reviewing the types of things we could mix Susan's dose into...and the reality of what we are about to do hit me -- hard.  It is one thing to sit in the Clinical Research Unit while Susan eats peanut...watching ever so carefully along with other medical trained professionals for the first sign of a reaction... is something else entirely different to think about having Susan eat peanut at home.  The enormity of my responsibility in this is...staggering.

With all that swirling through my mind, we began.  
I reminded myself that the home dosing instructions were not for today.
Or even (thankfully) for tomorrow.

And I focused on Susan, and today.

Ten doses.  That's a lot of doses.  And a lot of chocolate pudding.  And, with dosing at 30 minute intervals (with the option of delaying a dose if there were signs of reaction present), I knew we had a long day in front of us.  

With four of us watching (me, two clinical trial coordinators and one of the study doctors), Susan spooned the first dose of that potentially deadly mixture into her mouth calmly.  As I watched her, I marveled at her calm, at her trust.  

The doses were tiny at first, and, really, relatively easy.  It did not take a lot of chocolate pudding to mix the dose well and Susan felt fine.  At first.

9:55 am:  Dose One.
.5 mg of peanut protein -- that's 1/500 of a peanut, or less than .2% of a peanut.  (And yes, that decimal place is in the right place -- I checked with a very smart friend just to be sure -- thank you, Kristin.)

Susan -- who has unrestricted gaming on clinical trial days was happily playing Fruit Ninja, Bejeweled, and Toy Balls (a game we used to play all the time that we sort of forgot about).  Her lovie, Ga, was hanging out with her.  

10:25 am Dose Two
1 mg of peanut protein -- that's 1/250 of a peanut, or about .4% of a peanut.

After Dose Two, Susan continued enjoying her unrestricted gaming.  And, I couldn't resist a tower of empties (read:  completed doses):

I've had several people wonder what we DO while we are at the clinical trial appointments -- especially those that are lengthy in nature.  Let me tell you -- while I try to stay in touch with those who are closely following our visit by text message, photo and or e-mail, what I am REALLY doing during those visits is...watching.  

I have come to really trust the women running this clinical trial.  They are kind, compassionate, thorough and very, very smart.  They see Susan as a real person.  They are interested in her beyond her food allergy profile.  They care about her.  That was especially evident to me when Dr. R., who was attending the food challenge, watched the video of Susan's remarks at the FARE luncheon a few weeks ago.  Like me, she cried.  But, she's not Susan's mother -- she's (just) her doctor.  

As much as the doctors and clinical trial coordinators care about Susan, I know her best.  If she is going to have a reaction, I am the most likely to spot the first sign of it.  MY job during these clinical trail appointments is to watch ever so carefully

10:55 am Dose Three
2 mg of peanut protein -- that's 1/125 of a peanut, or about .8% of a peanut.

Susan did not report any changes after consuming the third dose of peanut protein, but, I noticed that her blood pressure was bouncing around a bit more than it had been...and I thought she started to look ever so slightly red in the cheeks, but, I wasn't sure...and so, I just...kept watching.

And yes, for those mathematically minded who are reading this, the dosing is cumulative, so, if one wanted to play with the math on this, one could -- by Dose Three, Susan had consumed 3.5 mg of peanut protein, or 1.4% of a peanut.  The problem with playing with math like this is that it is hard to know how much of the peanut protein was just hanging out in Susan's stomach and how much of it was being digested...but, there's the math, nonetheless.

11:25 am Dose Four
4 mg of peanut protein -- that's 2/125 of a peanut, or about 1.6% of a peanut.

I could see that Susan's blood pressure was bouncing around a bit, and it was clear by this dose that she was having some skin changes.  Susan was continuing to enjoy her unlimited gaming between doses, and at times, when we checked with her to see how she was doing, I felt compelled to remind her to pause in her game playing and actually thing about how she was feeling.  She doesn't complain, so, we were asking her to do something outside her norm -- and I wanted to be sure that she gave the very important question of how she was feeling a truly considered answer.

At regular intervals, Susan reported that she felt "fine."  

And then, just as the clinical trial coordinator and I were exchanging looks (for we could see the bouncing blood pressure and the skin changes), Susan reported that her stomach was "not feeling quite perfect."  She's stoic, but, we're SO on to her.  

We talked about how her stomach was feeling at length -- by then she had had the equivalent of more than three cups of chocolate pudding and not much else.  Was she hungry?  Did she want to take the rest of her doses in applesauce?  Maybe.  And NO.  I was right there with her -- the idea of applesauce on top of chocolate pudding wasn't very appealing to me, either.  Susan assured us that she was fine to continue.

Through this all, I have been amazed by her calm in the face of what is, essentially, poison to her.  Even when not feeling well, she is still willing to go forward, because...because why?  She trusts us.  She does not want to live like she does.  She believes in the science behind this.  She wants to be a part of the cure.  Staggering, really.  I am sure there are some children who would simply refuse to eat more -- or to do this at all.

With Susan's stack of "empties" growing, we pressed on:

I was impressed with how far Susan had been able to go, but, growing nervous, too.  If she was already showing signs of reacting with an 4 mg dose, would she really be able to get to a 250 mg dose?  I did not voice my concern (although the clinical trial coordinator and I shared plenty of looks) and I told stories Susan has never heard about my childhood to distract (me AND her).  

11:55 am Dose Five
8 mg of peanut protein -- that's 4/125 of a peanut, or about 3.2% of a peanut.

After her fifth dose, Susan asked for the lottery ticket we bought on the way to the CRU. Bad parenting, I know.  To explain, we have talked about how -- at least for us -- being in the clinical trial feels like winning the lottery, so, some mornings we stop to buy a lottery ticket to play while we are at the CRU.  This morning, before I had any idea how bad traffic would be -- and how late we would be as a result -- we stopped for gas.  And, as Susan was checking out her lottery ticket options, she spotted one that is a take-off on her current favorite game, Bejeweled.  How could I resist?  Anyhow, she played her lottery ticket between Dose Five and Dose Six.  (And I told myself that if she felt well enough to want the lottery ticket, that was a good sign...)  

As Susan scratched off her lottery ticket, I noted that her blood pressure was definitely up.  And if you look, you will see that her cheeks were red, and a bit blotchy -- clear skin changes.  Susan reported that her stomach still did not feel "quite perfect," but, she was willing to go forward.  

With our stack of "empties" growing, we pressed forward.  

12:25 pm Dose Six
15 mg of peanut protein -- that's 3/50 of a peanut, or about 6% of a peanut.

With a calm resolution that I think impresses everyone who has come into contact with Susan during this clinical trial, Susan ate the sixth dose of peanut protein in a few big bites.  

As the thirty minute observation period ticked by, I noticed that Susan was less interested in gaming...and remembered from the food challenge that she stopped gaming when the reaction began to increase in intensity.  She wasn't reporting anything different -- her stomach still did not feel good (she rated it a 2 on a scale of 1 to 5)...and I could see increased evidence of skin changes (she was redder...and I think I saw a few hives...and maybe some puffiness)...and her blood pressure was holding steady in the "up" range.

As I watched Susan eat the sixth dose, I started thinking hard about the reality of home dosing.  I had always understood that we would need to make some changes in our busy lives in order to ensure Susan took the dose early enough in the evening that we had a two-hour observation window before it was time for her to go to bed...and I knew she would need to have a parent with her at all times, but, the reality of what this could feel like to do at home was starting to frighten me -- just a bit.  And, a bit like Susan, I don't scare easily -- so this is a BIG admission.

12:55 pm Dose Seven
30 mg of peanut protein -- that's 3/50 of a peanut, or about 6% of a peanut.

After she finished the seventh dose, Susan put down her phone.  Her stomach was still bothering her.  She wasn't sure if she was hungry (entirely possible, as she hadn't had much to eat other than chocolate pudding), or if there was more to it than that.  I was pretty sure it had something to do with the peanut protein we kept sending its way...

We waited.
Susan assured us she was no worse than before...
and we waited some more.

And as the minutes ticked by, I eyed the remaining doses warily...  

60 mg
120 mg
250 mg

They are all just numbers, right?
But...I kept thinking about the effect of the cumulative dosing, the dramatic increase in each increment and the symptoms of reaction we were already dealing with...

And yet, even as I kept telling myself that they were all just numbers...

If I am totally honest, I will admit that the three remaining containers scared me more than the tower I could have made of the seven empties.  For sure.

12:55 pm Dose Eight
60 mg of peanut protein -- that's 1/10 of a peanut, or about 10% of a peanut.

As Susan ate the eighth dose, I was feeling torn.  This was incredible progress, right?  She was eating peanut.  But, I really didn't like the way she looked, and I was worried...

I wasn't even thinking about home dosing at that point -- I was just thinking how very, very hard it was to watch Susan eating something I knew could kill her.

As the minutes ticked by, Susan reported that her stomach was feeling "not as good" as it had been.  And, as it hadn't been feeling good before, that was really concerning.  After some discussion, it was decided that the ninth dose (120 mg of peanut protein!) should be delayed.

Susan's discomfort increased.  
All gaming stopped.

We could see evidence of more skin changes.
And her blood pressure and pulse were most definitely up...and climbing.

I couldn't just sit and watch any longer.
Even though it made it harder for me to watch her, I climbed into the reclining chair with her.  I wanted to be closer.  No, I NEEDED to be closer.

While nothing ever really felt out of control, I was constantly aware of the dangerous edge we were walking.

As Susan's reaction continued, the team decided to administer 41 mg of Benadryl IV push.  

That's a pretty intense way to get Benadryl...and it knocked her out.

Once Susan started reporting more significant signs of reaction, I was less able to keep really good track of the timing of, I'm much sketchier on the details about time and the like from this point forward.

But, I do know this.  While Susan rested, the doctor and clinical trial coordinator explained to me that, according to the protocol, if the Benadryl helped and Susan felt able, they needed her to attempt to take the next dose of peanut protein.  

120 mg

I was stunned, but, tried to control my emotions -- Susan has been very clear from the beginning that this is not just about her, and -- if the study protocol called for an additional dose, I wanted to allow her to try it...if she wanted to.  And...I was pretty sure she would want to. then, I was scared.  As I watched her, I found myself thinking that there was NO WAY we would be able to manage the home dosing -- it was too scary, the symptoms were too intense...the risks were -- simply, too (way, way TOO) great.

Time passed...and the team eventually announced that if Susan was going to attempt the next dose, she needed to do it.  They roused her, we explained, all the while a lump in my throat -- (wondering whether or not I was, in fact, being the best possible parent to her at that moment)...and she agreed to attempt the 120 mg dose.  

And a voice inside my head was pretty insistently saying, "SHE DOES NOT HAVE TO."  And yet, if this is not all about her (as she clearly and repeatedly has said it is not), then she almost did have to.

?? Dose Nine
120 mg of peanut protein -- that's about half of a peanut.  (Staggering.)

After some discussion, the team decided to have Susan start with half of the 120 mg dose, which essentially meant that she repeated the 60 mg dose...  

A sleepy Susan gamely spooned the 120 mg dose into her mouth (I don't have pictures -- I wish I did, for stamped in my mind's eye is how unwell she looked in that moment...and how resolute she clearly was).  And then, with alarming speed, Susan stopped eating, and -- on the verge of tears -- said she was going to throw up.  

She vomited. 
And she vomited...
And she kept vomiting.

For those of you who haven't been along for the whole ride, I *DON'T* do vomit, but, I gamely hung in there, hugging Susan and assuring her she would be okay -- wanting to be certain she did not allow fear into our space if at all possible.

After she was done, she laid back in the reclining chair and started to drift off.  I exchanged a look with the doctor, who quickly told Susan she had to stay awake.  We forced her to talk to us, and within minutes, she was complaining of feeling like something was "stuck" in her first she thought it was just from the vomit, but, as it rapidly worsened instead of improving, it was quickly clear to all of us that vomiting had not stopped the reaction (sometimes it does, although that hasn't been the case for Susan in the past).

I got to find out what was in that big red emergency bag...  

...Epi Pens, and assorted pre-measured IV-ready medications (among other things...that I'm surely thankful I did NOT see!).  

Susan bravely assisted the doctor in administering an Epi-Pen...and within minutes, she was much better...but exhausted.  We made her stay awake, talking to us, until we were certain the Epi-Pen had truly stopped the reaction.    

It was then -- as the clinical trial coordinator and nurse tidied up the space and the doctor made notes that the enormity set in for me.

I was cold -- ever so cold...and shaking uncontrollably.

As I sat there, hugging myself, I couldn't help but wonder if we really want this that much.  For the truth is, no matter what happens, there IS a price to pay.

Turning that over in my mind, I climbed into the reclining chair with Susan -- wrapping her in my arms, holding my brave, brave girl securely.  Even though her vitals were being carefully monitored, I wanted (needed) to be right there with her.  As I stroked her hair and listened to her breathing, I marveled at her stoic bravery -- at her determination to see this through.

Hours later, after examining Susan at regular intervals and having her eat something (Oreos and milk -- a slight improvement over the pudding from earlier in the day) the doctor sent us on our way.  We left bearing more snack packs of Oreos (Susan actually looked at me for my permission before accepting them -- and all I could think was like I would deny you ANYTHING at this point?) and a large hospital tumbler filled with water. 

I had a number -- 180.  That's 180 mg.  Best calculation (guess?) was that Susan had ingested 180 mg of peanut protein before having a full-blown anaphylactic reaction.  Of course, that was a cumulative dose...and she vomited up a tremendous amount of peanut protein and chocolate pudding.  (And YES, I know, I DON'T DO VOMIT, so, I just might be exaggerating, but, EVEN the doctor and the clinical trial coordinator noted that she had vomited "a lot.")

We were sure Susan was dehydrated, and, knowing that we (UNBELIEVABLY) were going to be back in the CRU the following day to try to confirm Susan's ability to tolerate a home dose of 30 mg, we all wanted to get Susan to the best possible place physically.

Susan was so tired that all she wanted to do was sleep more -- that's what a massive dose of Benadryl and a full-blown anaphylactic reaction will do to you -- but I tried to get her to drink a few sips of water every so often.  And then, she needed a bathroom stop, and even though we were only about 12 minutes from our house, I was not going to deny her anything at that, we stopped at a Thornton's in Highland Park (yep, we were THAT close to home!)

Enter the best thing of Susan's day (at least until that point):

Never underestimate the power of a Slurpee.  (Actually, this was a Freezee, but, still...)  It is clear, she is wiped -- pale, with circles under her eyes...but, she mustered a smile, saying "this will be good."  She was more right than she knew.


And all of the sudden, Susan was ready for dinner.  Not Zapatista, but, Michael's -- for a cheese potato.  I'd have let her eat anything she wanted (as long as there was no peanut involved!).

We stopped at Michael's Chicago Style Red Hots in Highland Park.  While it might seem a strange choice for a vegetarian, and I was once skeptical of their ability to handle food allergies, over the years, we have become loyal customers.  While they have a wide array of salad toppings (some dangerous for Susan), they will make anything we order using ingredients that come from their original containers, in the back, on a sanitary work surface.  They understand my paranoia about the microwave, and never "cook" our potatoes...and so, dinner was a cheese potato -- both kinds of cheese, please -- oh, and not cooked.  And while I feel the need to remind them every time, enough of the staff in their know us that I honestly believe I could stand there and not say a word and they would still get it right.  Pretty incredible.

And then, because we had missed most of an incredible day, and I wanted to offer Susan something special (the moon, really, had I been able!)...I hauled the cushions for our "green chair" (a double-wide, incredibly comfortable chaise lounge) out of our basement and set it up for Susan...who ate her potato there, talked of reading to Amelia there some day and then read her own book until she was ready for bed.

And now that one of the longest days of my life is over, and I have reflected some, I can say this:

I want this for her -- badly.
Even now.

I will not let my fears and misgivings get in the way.  
For, if possible, Susan wants this more.
She said as much as we stood in line at Michael's.

And a tiny, insistent little voice in the back of my head wonders why Susan wants this SO MUCH...allowing my fear that living with food allergies -- despite all we do to make it NOT about the way more terrible than I can even imagine...


  1. thank you for sharing. our week 12 appointment is on tuesday. my daughter is 9 and I am terrified. wednesday she gets her take home dose, and thursday I leave for a 4 day work trip. she will be in good hands, but I'm so worried about leaving her. how did your visit go the next day? did she have any stomach issues with the lower dose?
    I agree, this is so hard to watch them go through, but at the same time, how can we not do it? hoping things go well for you guys at home.

  2. Caryn,
    You keep talking about how brave Susan is - And she really REALLY is!! But also, YOU are so brave too. And such a good mom. This entry made me cry. I am thinking about what Susan is doing for my son, by participating, and all that you both are risking. You are *both* very special. x, Lisa