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.
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?
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.