After
the
Food
and
Drug
Administration’s
recent
decision
to
delay
the
approval
of
MDMA-assisted
therapy
for
post-traumatic
stress
disorder,
the
path
forward
has
become
less
straightforward
for
the
field
of
psychedelic
medicines.
But
this
isn’t
the
end
of
the
road,
according
to
a
panel
of
experts
last
week
at
the
HLTH
2024
conference
in
Las
Vegas.
The
new
drug
application
was
submitted
by
Lykos
Therapeutics
and
would
have
been
the
first
new
treatment
option
for
PTSD
in
over
two
decades,
according
to
the
company.
The
drug
would
have
been
provided
with
talk
therapy.
The
FDA
requested
in
August
that
the
company
conduct
an
additional
Phase
3
trial
to
evaluate
the
safety
of
the
treatment.
The
agency’s
choice
came
after
an
independent
advisory
committee
cited
several
concerns,
including
badly
designed
studies
and
allegations
of
sexual
misconduct
during
a
mid-stage
clinical
trial,
according
to
NBC
News.
When
Shereef
Elnahal,
under
secretary
for
health
in
the
U.S.
Department
of
Veterans
Affairs,
heard
the
news,
he
did
not
“feel
awesome,”
he
said
at
HLTH.
That
is
because
veterans
have
been
telling
him
since
“day
one”
of
his
job
that
this
line
of
therapy
could
be
“game-changing.”
However,
he
said
that
the
research
the
VA
is
doing
could
actually
answer
some
of
the
questions
that
the
FDA
advisory
committee
raised.
For
example,
the
organization
is
funding
a
study
at
the
VA
Rhode
Island
healthcare
system
that
is
looking
at
veterans
with
comorbid
alcohol
use
disorder
and
veterans
with
PTSD.
“Both
conditions
at
the
same
time,
a
randomized
digital
placebo
arm
and
a
therapeutic
arm,”
he
said
on
the
panel.
“The
therapeutic
arm
looks
very
similar
to
the
Lyko
study,
but
the
placebo
arm
has
low-dose
MDMA
as
the
placebo
to
address
what
the
FDA
[advisory
committee]
had
identified
as
a
functional,
unblinding
problem,
meaning
people
who
were
in
the
placebo
arm
kind
of
knew
that
they
were
because
they
didn’t
feel
the
very
obvious
effects
of
the
drug.
So
we’re
already
starting
to
plug
some
of
the
gaps
that
the
FDA
identified
to
make
the
science
better
and
try
to
accelerate
as
much
as
possible
more
veterans
getting
this
new
line
of
therapy.”
There
are
also
some
efforts
by
states
to
move
along
psychedelic-assisted
therapy.
For
example,
the
Arizona
State
Legislature
appropriated
$5
million
for
psilocybin
(or
mushrooms)
research
dedicated
to
PTSD
among
veterans,
noted
Kyrsten
Sinema,
U.S.
Senator
in
Arizona.
That
said,
it’s
still
important
to
get
FDA
approval,
she
added.
“Only
through
FDA
approval
can
we
ultimately
make
these
medicines
widely
available
around
the
country
in
a
safe
manner,
not
just
for
veterans
and
for
folks
who
are
suffering
from
PTSD,
but
for
individuals
who
are
victims
of
sexual
assault,
individuals
who’ve
had
traumatic
childhoods,”
Sinema
argued.
Sinema
also
noted
that
while
other
treatments
for
PTSD
exist,
they
aren’t
very
effective.
For
example,
in
exposure
therapy
(in
which
people
are
gradually
exposed
to
situations
they
fear),
people
have
to
relive
their
trauma
over
and
over.
This
leads
to
high
dropout
rates.
With
psychedelics,
patients
are
processing
their
trauma,
versus
“re-injuring
the
self
and
the
psyche
over
and
over.”
When
asked
what
Congress
is
doing
in
regard
to
psychedelic-assisted
therapy,
Congressman
Morgan
Luttrell
responded
that
this
is
a
“crawl,
walk,
run
scenario.”
He
noted
that
he’s
taken
these
medications
himself
and
is
a
big
advocate
for
them.
“We
don’t
want
to
overwhelm
the
system
because
even
though
these
medications
have
been
around
for
centuries,
it’s
a
very
new
concept,
especially
to
the
congressional
members
who
represent
their
base.
…
I
have
to
have
these
conversations
with
members
to
not
only
show
them
the
science
and
the
data
that
is
collected
but
share
my
personal
experience
and
why
it’s
so
important
that
we
move
forward,”
he
said.
“We’ve
put
legislation
in
place
and
dollars
in
place
for
the
VA
and
for
the
[Department
of
Defense].
But
again,
I
think
if
we
push
too
hard,
too
fast,
it
will
break,
and
we
do
not
want
to
do
this.
We’re
talking
about
lives
here.”
If
FDA
approval
of
MDMA-assisted
therapy
for
PTSD
happens,
there
is
still
the
question
of
how
the
healthcare
industry
will
pay
for
it,
noted
Ruth
Reader,
health
and
technology
reporter
at
Politico
and
moderator
of
the
panel.
Due
to
issues
with
sexual
misconduct,
it’s
possible
two
therapists
might
be
needed
for
treatment,
which
would
be
expensive.
Sinema
responded
that
there
are
more
trial
applications
going
into
the
FDA
for
group
settings,
which
would
make
treatment
cheaper.
“There’s
a
nonprofit
organization
in
Arizona,
Scottsdale
Research
Institute,
that
is
preparing
to
do
a
trial
for
MDMA
in
a
group
setting,
also
looking
at
psilocybin
in
a
group
setting,
that
allows
you
to
have
two
therapists,
but
also
allows
you
to
have
multiple
people
experiencing
their
own
therapeutic
experience
in
a
shared
setting.
…
I
think
there
is
a
world
in
which
this
can
become
available
and
affordable,”
she
said.
“A
big
issue,
of
course,
after
FDA
approval
for
all
the
classes
of
psychedelics
is
how
do
we
start
to
gain
insurance
coverage
so
that
people
can
get
access
to
this?”
Luttrell
also
noted
that
psychedelic-assisted
therapy
is
intended
for
a
“select
group
of
individuals,”
not
a
broader
market.
Photo:
HLTH