Photo by Rebecca Gould Photography

Monday, April 13, 2015


I sat with Susan just after waking her this morning.  In the quiet of the early morning, I asked her how she was feeling...and if she was really, truly certain she wanted to continue in the clinical trial.  She felt "fine," and without hesitation, she answered "yes."

Armed with that assurance, I determined that I was prepared to advocate that Susan be allowed to stay in the study should the need arise.

Based on our discussion, the on-call doctor had e-mailed me the criterion under which a study subject would have to be withdrawn.  A study subject must be withdrawn from the study if the investigator feels that it is not safe for the study subject to continue receiving treatment.  

Examples include:
  * - significant side effects from the study drug (any Bock’s criteria grade 3 reaction that is associated with hypoxia (less than 92% oxygen saturation) or blood pressure changes (greater than 20 mm Hg drop in systolic or diastolic blood pressure)
  * - serious or unexpected adverse event
  * - serious intercurrent illness
  * - progression of disease that requires alternative treatment

Or, if the study subject:
  * - desires to discontinue participation in this study
  * - is unwilling or unable to comply with the protocol
  * - becomes pregnant
  * - misses more than 2 consecutive study visits

The on-call doctor opined that she did not think Susan met the criteria unless the Principle Investigator and/or the doctors in Boston (who oversee the entire clinical trial) felt Susan should not continue due to safety concerns.  That last sentence was the part that worried me, and as the day wore on and I did not hear anything back, I worried more and more.  She asked if we could be at the Clinical Research Unit (CRU) at 1:30 pm the following day.  I agreed.
Any time.
Any place (even though it is always the CRU).
  Really -- we are committed, and what could be more important?

As the day wore on, I reminded myself that it was Sunday -- but, I also know just how engaged these doctors are.  I had no doubt that e-mails were being exchanged while a plan was laid -- and I worried that the plan did not allow for Susan's continued participation in the clinical trial.

I would not describe myself as a pessimist.  I do not generally believe my glass is half full, nor do I expect the worst of people or in life.  I have spent my professional career working with people accused of some of the most heinous crimes against other human beings, and even having seen some truly horrific things, I generally believe things will work out...even if I cannot always see the logical progression.

That said, by Monday morning I could see the problems unfurling in front of me as I contemplated the possibility that Susan might not be allowed to stay in the clinical trial. 

I knew if Susan was discharged from the clinical trial, it would be because the Principle Investigator or the doctors in Boston felt it was not safe for Susan to continue.

If that were the case, I could not see how those same doctors would be comfortable working with us to develop a plan for Susan to continue taking a daily peanut dose.

If that were the case, I could not imagine any (credible) doctor agreeing to follow Susan if she continued taking a 2000 mg dose of peanut protein...and then where would we be?

I didn't know.
I couldn't imagine walking away from the (hard-fought) ground Susan had gained.

And so, I prepared myself to advocate on Susan's behalf, just as I had in the past.

And then I got an e-mail from the clinical trial coordinator asking if we could go in earlier -- as soon as possible, in fact.  She said they wanted to be sure they had physician coverage, which I tried to take as a reassuring sign, even though I was fairly certain they would want physician coverage if they were discharging Susan, also (and I knew there would be paperwork and surveys involved, too).

En route to Ann & Robert H. Lurie Children's Hospital, Susan and I talked.  She remained clear -- she wants to see the clinical trial through.  She does not want to stop eating peanut.
She will embrace the deadly beast.
She said, "Mom, if I don't do this, who will?"
  (That's right, Susan -- if you want something, make it happen.)

We talked about ways to decrease the risk of an adverse (read:  anaphylactic) reaction.  Susan and I agreed that there are things we cannot control -- seasonal allergies, an under-the-weather (but not obviously so) immune system, hormones -- and to focus on that which we can control.

-- We agreed that she would pick a food that did not have to be cut, split or otherwise divided for her dose.  That narrowed the list of options dramatically -- Nutter Butters, peanut butter or that Reese's Peanut Butter Cup that I have been desperately wanting her to try (but not like this, not under these circumstances...).

-- We agreed that even though Susan was cleared to eat foods that potentially carried trace amounts of tree nuts (read:  cross-contamination, cross-contact) several years ago, I would research the safety of the three options -- seeking a peanut food product that does not possibly come into contact with any tree nuts other than almonds (which she regularly eats without issue).

I shared wisdom generated by many parents of children living with food allergies regarding the differences between the EpiPen and the Auvi-Q.  I explained that there are people who believe the Auvi-Q is less traumatic because the needle is shorter and the duration of the injection is significantly shorter.

Susan said:  "MOM -- I still have to inject myself."  (Slowly, but not unkindly -- a bit as though I were a young child requiring patience or someone cognitively impaired.)  She added, "Once the needle is in me, the hard part is over."
While Susan carries 2 EpiPens and an Auvi-Q, she is like me in that she is all about the tried and true.

When we arrived in the CRU, it was immediately apparent that the plan was for Susan to take half of her dose (that meant cutting that dreaded peanut half in half again.)  Really???

I did it -- getting 1 pretty good looking half of a half while shattering the rest.

The clinical trial coordinators and doctor overseeing Susan's dose examined Susan and then Susan took her dose.  It was super-official, in a plastic baggie.

We hung out for an hour, talking about the best food product for Susan to use in dosing and marveling at the fact that -- while anaphylaxis like what Susan experienced yesterday should not happen at this point in the clinical trial, it still does.
(There is so much yet to learn.)

And then, after an hour, when Susan was totally fine, we went in search of our favorite nurse from Susan's recent hospitalization, who sadly, was not working.  Then, we played with the buttons in the elevator -- Susan made it be "night."  [That's just one of the many things I love about Ann & Robert H. Lurie Children's Hospital -- there are countless opportunities for kids (and adults!) to just]

After, I took Susan out to lunch.  I hadn't packed her a lunch because I intended to pick her up before lunch, and I knew she would have missed lunch by the time I could get her back to school anyhow.

As we walked, I made her stop so I could photograph her cheeks -- which, while decidedly not hivey (even though there was a time when I would have said they were -- one of many things I have learned while in the clinical trial) were

As we sat at our table -- over baked potatoes stuffed with broccoli, tomatoes and cheese -- I asked her how she felt knowing that she was going to be allowed to stay in the clinical trial.

Susan replied benignly that she was "glad."
Something about her response made me ask her if she had been worried that she would not be allowed to remain in the clinical trial.

She said, with a calm and quiet clarity:  "No." 
I gave her a questioning look.

With certainty, Susan said softly, "Yes, things usually work out the way they are supposed to."

While I could certainly have given Susan plenty of examples to the contrary, I decided instead to say, "I am so glad that you know that about life."

There is time for her to learn otherwise, and I am going to hope beyond hope that Susan does not learn otherwise as the result of her experience in the clinical trial.

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