The Tale of a Guinea Pig -1.29.2021
At the time, actual guinea pigs were in the height of their popularity
as research subjects. The animals, a laboratory staple through the 19th and
early 20th centuries, played a role in medical breakthroughs ranging from the
discovery of vitamin C to the development of Pap smears. In the mid-1900s, guinea
pigs began to fall out of use, replaced by rats and mice. Over time, the term
“guinea pig” in a lab context became more strongly associated with people—for
better or for worse.
https://www.theatlantic.com/science/archive/2015/09/life-of-a-professional-guinea-pig/406018/
You know me as Dr. Batisky, executive director of Pre-Health
Advising in the College, Professor of Pediatrics and Small Group Advisor in the
School of Medicine, and pediatric nephrologist at CHOA. I wear a few other hats at the moment, and I
have also had various research experiences across my career in basic science
labs, clinical trials, registries and even qualitative studies. But one of my more recent roles allows me to
hold the title of ‘Human Guinea Pig’, AKA clinical trials subject.
I am currently enrolled in the Moderna SARS-CoV2 phase III
study to establish efficacy and safety of the newly developed mRNA vaccine to
protect from COVID-19. As a pediatrician,
I have long understood the value of vaccines to prevent various childhood
illnesses, and as a clinician currently practicing in the midst of a global
pandemic, I know of the importance of developing new ones. In my personal clinical experience I also
understand the value of the public health initiatives such as masking, handwashing
and social distancing. While I have seen
a number of COVID-19 positive patients in the last year, I am not truly on the
front lines like an Emergency Medicine physician or Trauma Surgeon, yet I felt
the need to pitch in any way I could.
When I heard that the Moderna phase III study was recruiting
for subjects, I quickly volunteered to participate. I waited for a call, got through the phone
screen and went in to have an in person study visit. I read through a several page, complex and
frankly somewhat intimidating consent form.
I realized what that must be like to read without the education and
insights that I had. It’s the first time I had been on the giving end of the
informed consent process, and it’s the first time that I had willfully offered
to participate in a clinical trial. I
reflected on the trust that a subject places into the hands of the research
staff – both PI and study coordinator – and I also gained insight as to how
that trust might not only be broken, but how hard it would be to overcome
breaches of that trust. And of course,
there are the practical unpleasant aspects of the trial – time spent waiting,
needles, blood draws, watching for side effects, keeping logs.
The way this study worked, I went for the first in person
study visit, which took close to three hours.
After discussing and signing the consent form, I had an exam, a nasal
swab, a blood draw (8-10 tubes!) and a first dose of vaccine (yes, a
shot!). This was a double-blind, placebo
controlled study, meaning the study subject (me) and study staff (PI and
coordinator) are unaware if I got the actual vaccine or the placebo (the
‘dummy’ vaccine, likely salt water, but still a shot!). I was sent out, equipped with a ruler, a
thermometer, and a newly downloaded app on my phone to track symptoms for a
week. I took my temp each day and
recorded that as well. Weekly I got
phone calls. And yes, they paid me for
my time and effort.
A month later, I went back, the visit was shorter, but I had
more testing – nasal swab, blood draw – and another shot, followed by similar follow-up
procedures. And in the meantime, I continued
to maintain the public health guidance and being made fully aware that should I
develop symptoms of illness or exposure to a COVID-19 patient, I would call the
study team and assess whether or not a visit was warranted.
As the world awaited results of the early vaccine trials,
the end of 2020 was drawing near.
Moderna submitted their data to the FDA in late December and received an
EUA – Emergency Use Authorization.
Basically, since the vaccine showed promising effectiveness and an
acceptable safety profile, it could be used given the dire circumstances of the
global pandemic. At that point, I had
choices to make: do I go out and just
get a vaccine, given my status as a healthcare provider? This was an option, given that clinical trial
participation is always voluntary. That
seemed extreme. I contacted the study
staff and decided to await their guidance, and on January 6, 2021 I went to the
study center to review the amended protocol. I knew that I wanted to be ‘unblinded’, and I also
knew that if I found out that day that I had gotten placebo, they would offer
me the ‘real vaccine’. So I took an
early appointment, expecting to be there awhile and wore a short sleeve
shirt. I fully anticipated that I had
gotten the placebo, given that I felt absolutely fine after both doses…and it
is said that the second dose is more likely to result in side effects.
I arrived at 7:20a for my 7:30a appointment, reviewed and
signed the consent form for the amended protocol, opted to be officially
unblinded, while staying in the study as a participant. I had another nasal swab and another blood
draw. And I anxiously waited as the
study coordinator logged into the Moderna system, verified my identity, and
pushed the unblinding button. And then I
found out that I had gotten the actual vaccine!
What a pleasant surprise, given that my second dose was given on
September 14, 2020. I remain in the
study for another couple years, hoping that I can help answer the question
about longer term safety and effectiveness.
Why did I do this? I
felt the need to ‘do something’ in the midst of this global pandemic. I have gained some interesting insights in
the process of a study from a different perspective, and I have gained empathy
into why some people might mistrust science.
Yet, fully expected that I had gotten placebo, it amazed we that I had
gotten through the two doses without symptoms.
And that reminded me of the adage that if we knew all the answers, there
would be no need for research.
So, having an open mind, being willing to pitch in where you
can, and reflecting on the experience has taught me more vital lessons. Being a human guinea pig is not for everyone,
but I found it helpful for the sake of pushing forward the agenda of science as
well as enhancing my empathy – elements of which one could consider, according
to George Bernard Shaw as ‘rearranging the world’. That’s my tale, and I’m sticking to it!