Clinical Trial Acceptance Testing

Interview

The interview was pretty much a recap of the written application and establishing rapport with the clinic. I only lied on one question, otherwise, completely honest.  After the interview and signing the release forms for admittance testing the first step is confirmation the allergy is real. This is done with a skin test. They applied six allergens to my skin and waited.

I’m cured

Yep, my happy ending. I didn’t react to peanuts. I must have grown out of it.  I had mixed feelings about this. Wouldn’t it be great to not worry any more? But if so, then how long have I been torturing myself unnecessarily??

But wait, not only did I not react to peanuts, but not to pollen or dust mites or mold. I am superhuman!

The doc looked at my arm and asked if I had been taking any antihistamines in the last 7 days.  Of course not,  they told me not to and I didn’t.  He said “you didn’t react to that one, that’s pure histamine, everyone reacts to that one.”  Then he looked something up on the computer. “It seems the medication you are taking has an anti-histamine side effect.” Oh, the irony! The medication I’m taking because of the PN ANA is going to eliminate me from the potential cure for PN ANA! Then he went off to consult with others.

Histamine is the control, it’s there to prove the test is valid.  Just like this skin test a clinical trial needs a control group too, to prove the trial is valid.  In this trial 20% of the participants would be in the control group, that means 20% are given pure placebo and are not going through real OIT.  If you are considering being in a clinical trial you will have to accept this possibility and if you can’t accept being part of the placebo group then a clinical trial is not right for you.

He came back and said, “To be considered for the trial you would have to change meds and come back for another round of skin tests.” Now keep in mind this is a clinical research environment. This is not just their job it’s their career. If I had lied about my anxiety or the medication I was using to treat it I would have been wasting their time and I’m sure they would have thanked me and shown me the door. But they didn’t, they were giving me a second chance, and for that I am truly grateful.

Second try

I changed my meds as soon as I could and was stable on the new one for weeks before I had the chance to return for the repeat testing. This time was much better, the results were exactly as expected. I even announced on facebook, “hey, guess what? I just found out I’m allergic to peanuts!”  Now I could schedule myself for the:

Double blind food challenge test

The procedure is simple. On two separate days they feed you either allergen or placebo and monitor your reaction.  If you react you get treated, observed, and when it is CLINICALLY safe they let you leave.  These are scheduled a week apart on the assumption that you will get an antihistamine on the first day and need a week to clear it from your system for the 2nd day.

Day 1

They put me on a bed. For the dosing I had to be on the bed.  The little kid I was sharing the room with didn’t have to be on the bed, she had toys and crayons and didn’t have to be on a bed. I guess if she went ANA they could pick her up and treat her.  Not so easy for an adult.  But really, c’mon, no crayons??

I’ve got a blood ox monitor on my finger and a blood pressure cuff on my arm and they baseline me at 120/80.  Really? 120/80? that’s a little higher than I would expect, but ok. They keep checking in to see how I’m doing and they come back with the first dose in mixed in with applesauce. The protocol is dose, wait 15 min, then updose. The first dose is 5mg, the second 20mg, and so on.  “First a little on the lips, wait 30s, then lick your lips, then eat the dose.” Amazingly similar to what I had already been doing the last 30 years.

I’m sitting upright in the bed.  She shows me the cup and label. It has my name on it. Then reads the label to me

“5mg of peanut protein.”

I was actually going to eat peanuts.  How surreal!  I NEVER eat anything with I warning label that indicates even the slightest potential of cross contamination.

First the lips. “what do you feel?” “Nothing” I replied. then I licked my lips. I tasted mostly applesauce and the oat flour. Then there it was, and I thought the test would be over.

“there’s peanut in here, I can sense it.”
“How do you know?”
“I feel it in my sinus”
“Anything else?”
“No”
“OK, eat the rest, I need to see a visible symptom”

Yikes! Exhale… I was afraid of this… not mentally afraid of actually eating the peanut, if that’s what it really was, but I was afraid that my body/anxiety wouldn’t let me. My years of preparing for this moment paid off, and I was able to swallow the rest of the mixture.

“So I thought this was supposed to be a double blind test, but I’m sure there is peanut in there”
“It doesn’t matter what you believe, what’s important is that I don’t know which one it is. So, how are you feeling?”
I pause, I close my eyes, I concentrate within to see if I can feel any reaction…
“Anxious”
“I know” said the doc, “your blood pressure is 145, just try to relax”

personal training effects of exercise on bp

My body was responding as if I was exercising at 120W output, but I was sitting quietly in a hospital bed. Anxiety is a silent killer and if peanuts weren’t going to kill me then anxiety surely would. I needed this treatment.

So I close my eyes and try to relax.
“but don’t close your eyes and don’t lay down”
Ok, I guess I have to meditate with my eyes open.

Tick, tick, tick … The first dose is 5, the next dose is four times bigger. Can I handle it? I really don’t want to, please don’t make me eat more peanut. One minute, two, three, four, and bingo, the lobster as cooked as a bright red rash appears on the back of my hands.

“OK, you are done, here, have some zyrtec, we have to watch you for 2 more hours, then you can go.”

And I was quite relieved that I didn’t have to updose. I could relax and I felt tired. Wow, this is not going to be easy.

I just hope this wasn’t a psychosomatic reaction.

One week later

Same drill as before but I went in thinking “What if last week was PLACEBO? If that’s the case then I’m out. Or what if since I believe that this is placebo that I don’t react?”  Why do I have to over analyze everything??

I’m sitting upright in the bed.  She shows me the cup and reads me the label “5mg of peanut protein.” First the lips. “what do you feel?” “Nothing” I replied. then I licked my lips. I tasted oats.

“What do you feel?”
“Anxious”
“nothing else?”
“No”
“OK, eat the rest”

For the next four hours, every 15 minutes was an updose which was a mixed in of applesauce.  It was obvious the oat flavor was getting stronger as it progressed and my anxiety was gone. Even though before each dose she read the label and said I was eating peanut I knew it was not.

I was relaxed and relieved. Then the dosing stopped and I still had to wait 2 more hours for observation. When everything was complete the study was unblinded (converted to ‘open label’) and I had passed with flying colors.

Now that the test was open label the doc was free to talk with me outside of the confines of the double blind test protocol, and she asked my a puzzling question. I later realized they work mostly with kids, so the question made more sense to me later.  She asked:

“Since you reacted to peanut last time you knew this morning was placebo.  Why were you anxious?”

I replied “The label said it was peanuts. You read the label to me and told me I was eating peanuts”

and as she turned away I realized that allergists are not psychiatrists.


You can read the whole thing for free if you subscribe to KindleUnlimited. Here’s the book:

http://www.amazon.com/Living-Peanut-Anaphylaxis-Threatening-Allergies/dp/1512050814/ref=tmm_pap_title_0

© MICHAEL G SPORER AND LIVING WITH PEANUT ANAPHYLAXIS, 2015

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