CASE STUDY 1
Nick is a researcher at a pharmaceutical company, working in the vaccines division.
He is part of a team that has developed an experimental vaccine that they hope
will be effective in preventing infection with Ebola virus. This work has attracted
lots of attention, both from the directors of the company and from international
health organizations, in light of outbreaks of Ebola that are happening in Western
Africa.
The director who oversees clinical trials for the company lays out a plan to
test the vaccine in the outbreak zone. Research subjects will be randomly assigned
to the experimental group (injected with the experimental vaccine) or the control
group (injected with a placebo), without subjects or researchers knowing who
is in which group until the conclusion of the study, and their health will be
monitored over the course of the outbreaks. Because it is currently very expensive
to produce the vaccine, the company wants to get as much clear data on whether
the vaccine works as quickly as possible. Therefore, the clinical trials director
stresses, no doses of the experimental vaccine will be distributed to patients
outside the placebo-controlled trial. The process of getting official permission
to conduct the study from local health authorities in West Africa is well underway,
and the director says that if all goes well they will start recruiting subjects
for the trial in a few weeks.
Nick is excited that the vaccine he helped develop may help people in the outbreak
zone who might otherwise become sick with (and maybe even die from) Ebola. But
he is a little worried that some African patients in the trial may think they
are getting the vaccine when they are actually getting a placebo instead. Given
how devastating the Ebola outbreak has been so far, and how wary people in the
outbreak zone have been to come to the treatment facilities rather than hiding
from health officials in their homes, Nick doesn’t want their clinical
trial to make things worse for the people the vaccine is supposed to help. Then
again, the director overseeing clinical trials has been doing this kind of research
study for other vaccines the company makes — and he has much more authority
within the company than Nick does.
Should Nick share his concerns about the placebo-controlled clinical
trial of the vaccine with the director overseeing the trial? Why or why not?
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