OPINION
DOCTORS Lounge
seling just for failing a quiz.
The programs are modeled on a sort
of group therapy and devoted to the cele-
bration of failure as a steppingstone to life
fulfillment. The University of Texas has an
app called “Thrive” where you can get per-
sonal coaching: from hearing other students
talk about their failures in life and what
happened after, from bad dates to bad flunks
to bad drugs to bad hair days. Online is the
life of the young, and online is the lifeline,
as well. Multiple colleges now have formal
stress counselors, coaches and seminars
about how to take a punch and thus know
yourself better.
Jessica Bennett wrote in the NY Times
in June about Smith College, which devel-
oped a course on failure, with a syllabus
describing “a formalized program in which
participants more accustomed to high test
scores, and perhaps a varsity letter, consent
to having their worst setbacks put on wide
display.” Developed in part by Rachel Sim-
mons, the course is called “Failing Well” and
is designed to nurture resilience.
When students enroll in her program,
they receive a certificate of failure upon
entry, a kind of permission slip to fail. It
reads: “You are hereby authorized to screw
up, bomb or fail at one or more relation-
ships, hookups, friendships, texts, exams,
extracurriculars or any other choices asso-
ciated with college… and still be a totally
worthy, utterly excellent human.” Many of
the students hang their certificates up in
their rooms.
I read this and think, I’m so lucky. We
are all so lucky. We already have those tes-
taments to the power of failure hanging on
our walls: our medical diplomas and Board
certifications. They remind us of what we
don’t know, and in medicine, understanding
that fully is how we survive.
Dr. Barry practices Internal Medicine with
Norton Community Medical Associates-Bar-
ret. She is a clinical associate professor at the
University of Louisville School of Medicine,
Department of Medicine.
RITES AND RIGHTS, Tries and Trials
Goetz Kloecker, MD
A
majority of states already have
adopted a “Right to Try” legisla-
tion allowing gravely ill patients
access to investigational drugs.
Congress is working on federal
legislation to allow such drugs to be given
to desperate patients outside a clinical trial.
This would happen after dose-finding Phase
One trials, bypassing FDA approval.
The bill would protect manufacturers
and prescribers from liability. The downside
of this law, as described in a recent NEJM
article, would be unintended harm by insuf-
ficiently tested drugs that lack FDA advice
on safety, which is given in 10 percent of the
“expanded access” program. This program
has reviewed 5,000 requests over four years,
and 99 percent of single patient expanded
access applications were approved by the
FDA. Emergency use can be authorized over
the telephone (Jarow J., 2017).
We have used compassionate use and
expanded access programs for patients with
advanced cancer, whose circumstances did
not allow enrollment into clinical trials. In
my experience, the FDA approval was more
a required ritual than a hurdle, taking up
limited time (similar to a third-party payer
“doctor to doctor” review to get coverage
authorized). It may appear to be a bigger
hurdle than it actually is for doctors who
have not contacted the FDA before.
However, even if federal “Right to Try”
legislation is passed or if the FDA grants
individual access, physicians will still need
to receive approval from the study sponsor/
drug manufacturer, insurance and IRB to
proceed with the new drug/device outside
a trial.
This leads me to the bigger problem: the
state of clinical trials in the US. Legislative
intervention may be needed to enable “The
right to try clinical trials.”
not help. Poor patient awareness of trials
is a major obstacle. As an example, out of
1.7 million newly diagnosed patients with
cancer in the US, only 3 percent are enrolled
in clinical trials. The enrollment rates are
even worse for minorities and elder patients.
Clinical trials are a necessity for evi-
dence-based medicine, the data and clinical
experience that allow us to treat our patients
effectively.
Giving individual desperate patients the
right to accelerated access is important, but
legislation to make new treatments available
to our patients should not stop there.
More and more clinical trials are sent
abroad by the 20 largest US pharmaceutical
companies according to the National Acade-
my of Sciences. Over half, or 13,521 of their
study sites out of 24,206, are now abroad. To help millions of patients receive a
well-tested drug or device, our represen-
tatives should go beyond removing a small
ritualistic regulation and give doctors in
community and academic practices more
rights and fewer obstacles to offer clinical
trials.
Costs, administrative and regulatory
requirements, the lack of incentives, and
insufficient training in clinical research bar
the way. The lack of standardization in in-
formed consents and case report forms does Dr. Kloecker is an associate Professor at the
University of Louisville School of Medicine Di-
vision of Medical Oncology and Hematology.
He is the director of the Hematology-Medical
Oncology Fellowship Program.
MAY 2018
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