E6 EZ EE THE WASHINGTON POST.TUESDAY, JULY 28 , 2020
AKILI INTERACTIVEtrip to the pharmacy is needed:
Doctors and nurses will be able
to prescribe the game by giving
parents a code to download an
app.
Akili’s website touts its digital
approach as “the future of medi-
cine.” But some critics say: Not so
fast. “It’s a marketing ploy,” said
clinical psychologist and re-
searcher Russell Barkley, author
of several books on ADHD.
Barkley and three other ADHD
experts who reviewed Akili’s re-
search said the firm was over-
promising by implying that En-
deavorRx can provide meaning-
ful help for children struggling in
school and at home with the
sometimes-debilitating neurode-
velopmental disorder, whose
symptoms include distraction,
forgetfulness and impulsivity.
“I’m a little shocked and more
perplexed about why the FDA
would approve this and allow it
to be paid for by insurance,” said
Mark Rapport, head of the Chil-
dren’s Learning Clinic at the
University of Central Florida,
who has published extensive re-
search on other brain-training
programs making similar claims.
“I abhor seeing desperate par-
ents spend money based on emp-
ty promises.... On moral
grounds, I think it’s wrong to tell
people to get their doctors to
prescribe this when it does noth-
ing of real-world importance.”
In an email, Akili chief execu-
tive Eddie Martucci said the
company sought the FDA ap-
proval “to give families and doc-
tors full confidence in our prod-
uct.” He called the criticisms
“inaccurate and a misunder-
standing of the FDA process,”
adding: “We’re excited about this
FDA labeling that clearly shows
ADHD FROM E1 EndeavorRx is a low-risk, target-
ed treatment for a cognitive is-
sue.”
In dispute is the real-world
value of what is being “targeted.”
Akili’s strongest evidence of
EndeavorRx’s potential benefits
is children’s performance on a
21.6 minute-long, continu-
ous-performance test known as
TOVA (Test of Variables of Atten-
tion). The test, described by the
Tova Co. as “long and boring,”
requires participants to push a
button intermittently after see-
ing a certain geometric shape.
Akili’s leading study in sup-
port of its FDA clearance, which
the company paid for and which
was published last February in
The Lancet Digital Health, a
peer-reviewed journal, found
that 36 percent of children who
had played its game for 25 min-
utes a day, five days a week, for a
month, no longer had a deficit of
attention as measured by the
TOVA. But the critics questioned
whether the change was likely to
affect their schoolwork or behav-
ior.
“The effects just don’t general-
ize,” Barkley said. “You get better
at playing the game and anything
similar to playing the game.”
Martucci countered that En-
deavorRx is specifically designed
to help children with ADHD who
struggle with specific attention
issues. “Even though inattention
is often less recognized than
overt symptoms like hyperactivi-
ty, we’ve heard from numerous
families and physicians that they
are seeking new options to spe-
cifically help children living with
the day-to-day challenges caused
by attention issues,” he said.
The FDA cleared EndeavorRx
as a Class II medical device (a
category that includes powered
wheelchairs and some pregnancy
kits) through a regulatory review
process that is less rigorous than
the one required for new medica-
tions. Now that EndeavorRX has
been cleared, future developers
will only need to show a “sub-
stantial equivalence” to the ap-
proved game.
E ndeavorRx is based on soft-
ware invented in the lab of Adam
Gazzaley, a neuroscientist at the
University of California at San
Francisco. He is now a board
member of Akili. The firm began
its pursuit of the FDA approval in
2013, submitting data from five
studies involving a total of more
than 600 children.
Four of the five studies, one of
which is still unpublished, were
wholly or partially funded by
Akili, a ccording to the company.
The Lancet Digital Health report
said the lead author of that study
was a paid consultant with stock
options in the firm and three
other authors were Akili employ-
ees. It’s not rare for companies to
pay for such research, but peer-
reviewed journals require such
relationships to be disclosed as
potential conflicts of interest.
T he authors of the Lancet
study warned that their results
weren’t sufficient to suggest that
the game substitute for more
established treatments for
ADHD. Among the limitations of
their study, they noted that they
had excluded children taking
ADHD medication or who had an
additional “significant” psychiat-
ric problem, leaving in question
whether even the TOVA improve-
ment would apply to those
groups.
The authors also disclosed that
they found no difference between
parents’ assessments of children
in the EndeavorRx group and a
control group who played a com-
puterized word game. Bothgroups of parents reported im-
provements, suggesting there
may have been a placebo effect,
and leading the authors to specu-
late that “any intervention that
requires the patient to engage in
a regular, structured setting that
may include repeated failure or
repetitiveness can be seen as a
potential intervention for
ADHD.”
The case of EndeavorRx re-
vives a broad and long-simmer-
ing controversy over the benefits
and risks of computerized
“brain-training,” part of a global
industry projected to be worth
more than $8 billion by 2021.
For several years, researchers
and industry leaders have debat-
ed whether playing “brain
games” can meaningfully im-
prove memory and other cogni-
tive skills, or whether the money
and time they require might be
better spent on more evidence-
based activities such as physical
exercise or cultivating friend-
ships.
Although Akili’s Lancet study
said it found “no serious adverse
effects” from playing the game,
the authors disclosed that about
7 percent of trial participants
experienced “mild or moderate”
problems including frustration,
headaches, dizziness, nausea and
aggression.
Yet critics say they’re less wor-
ried about these potential issues
than the risk that parents will
waste time and money on what
Rapport called “a delightful dis-
traction that has no effect on
school performance or learning,”
when those scarce resources
might be better spent on tutoring
or other educational activities.
Such parents constitute a large
and lucrative market, given that
some 6.1 million U.S. children
ages 2 to 17 have been diagnosedwith ADHD, which can lead to
school failure, social ostracism
and defiance at home. Surveys
show 62 percent of these children
take medication, most commonly
stimulants. Yet the pills are wide-
ly stigmatized, don’t always help,
and can involve severe side-ef-
fects, leaving ever-hopeful par-
ents vulnerable to a cottage in-
dustry of controversial and of-
ten-hyped alternatives, such as
elaborate exercise regimes, com-
puter games, nutritional supple-
ments and fidget-spinners.
“It is so hard to see your child
struggle to fit in a world where
they fail to meet expectations,
not because there is anything
wrong with them but because it
is easier and more cost-effective
to cater to just one type of kid,”
said Elisa Castillo, a hardware
engineer and mother of two in
Fremont, Calif.
W ary of starting medication
with her son, now 12, who was
kicked out of his first-grade after-
school program for misbehavior,
Castillo has spent hundreds of
hours investigating and trying
non-pharmaceutical approaches,
including Omega-3 supplements
and blood tests to check for
mineral deficiencies, and signing
up for a clinical trial of a comput-
er game (not EndeavorRx) in
Gazzaley’s lab, which required
her to drive her son for 80 miles
round trip to San Francisco for 10
two-hour sessions.
After failing to see any im-
provements, she has crossed
computer games of all types off
her list, she said.
“I actually think my son’s video
game addiction is a more serious
problem than his ADHD,” she
said. “I have to do everything I
can think of so he isn’t playing
every minute.”
[email protected]EndeavorRx: Future of medicine or m arketing ploy?
An image from
EndeavorRx, a digital
game that may be
prescribed to treat
children ages 8 to 12 who
have been diagnosed
with attention-deficit/
hyperactivity disorder.The case of
EndeavorRx
revives a broad
and long-
simmering
controversy over
the benefits and
risks of
computerized
“brain-training.”
from going to college, working in
an office or even just going to the
movies. “All the stuff we took for
granted.”
Of course I understand.
In five months, more than
140,000 Americans have died be-
cause of covid-19, the disease
caused by the novel coronavirus.
Millions have lost their jobs and
some have lost their homes; un-
like me, many had to work in
unsafe circumstances, putting
themselves and their families at
risk.
I feel guilty saying that while I
was worried about what was hap-
pening I enjoyed this time, but, I
have enjoyed this time. And as it
comes to an end, I’m nostalgic.
I’m a freelance writer and I liked
having my husband around, not
only to help with child care, but
also to just be with. It’s given me a
taste of what his impending re-
tirement will be like — and it was
good. With Zoom classes, I got a
sense of how my 9-year-old son
operates in school and what I
need to tweak to make his educa-
tional and social experiences bet-
ter.
I came to see that the hamster
wheel my son — and I — were on,
where I overscheduled him with
playdates and activities because I
thought as an only child he
should never be alone or idle, was
not the best approach.
PANDEMIC FROM E1 While my son missed his
friends, he was fine without activ-
ities every single day. He found
things to do, like making bridges
and three-story structures with
Popsicle sticks and a glue gun,
making a birdhouse out of
Magna-Tiles, and reading on his
own, after he discovered the
“Harry Potter” series. He survived
— and I felt more relaxed not
having to drive him to and from
suburban New Jersey every day
after school.
As we all emerge, I will miss
that. But it’s not just me.
Kelly Moore, a clinical psychol-
ogist and program manager at the
Children’s Center for Resilience
and Trauma Recovery at Rutgers
University, said people with social
anxieties also have found this
time to be oddly comfortable.
They didn’t have to go out, she
said. Some of her regular patients
were so unstressed with stay-at-
home orders that they didn’t feel
the need to have remote therapy
sessions.
“I had quite a few clients who
said, ‘Actually, we’re doing a little
better right now,’ ” she said. “I
don’t know that it’s a good thing.
At some point, they’re going to
have to go out into the world
again.”
Alex Elbogen, a 26-year-old
computer programmer in New
Jersey, is well aware of that. He
was so uncomfortable in social
situations, he finished high
school remotely through a school
in California. “I feel really good by
myself. I feel more relaxed and
peaceful,” he said. “If I spend a lot
of time with people, I start getting
tired, in the way you might gettired when you’re overwhelmed
with something.”
During our quasi-lockdown, he
got to be by himself, and he didn’t
have to deal with friends and
family telling him he had to go
out more. “I was doing the same
thing I did before. There was just
no one commenting on it,” he
said.
For some, it’s not so much
getting away from people: It’s
being pushed toward them, such
as family. Dawn Shurmaitis, a
writer who lives in Stockton, N.J.,
said she spent significant time
with her older sister for the firsttime in decades, and it was mem-
orable.
“We did silly stuff, like facials,
and she complained mightily
about my veggie ‘gruel,’ but we
also read each other’s stories and
watched old home movies of our
parents, shot at the age we are
now, and we missed them all over
again, together,” Shurmaitis, who
is middle-aged, said. “Now that
she’s back in her own home, I miss
her every day.”
Shurmaitis said she’s going to
miss what she now calls, “The
Great Pause,” as we all begin to
return to our crazy, stressful,
though now often different, lives.
“The rescue ship is in sight, and
we’re having to leave our little
islands,” she said, “and put on a
bra and lipstick.”
Stephanie Schaich Bricken, a
designer in Spring Lake, N.J., 54,
feels similarly. She loved spend-
ing more time with her two sons
and husband and knowing that,
every night, they’d all be together
for dinner. They played games
together, watched movies togeth-
er, even cleaned the house togeth-
er. They were a team, Bricken
said.
“I didn’t have to jockey for time
with my teens, or shut down a
demanding request for dinner
with their friends or say, ‘No,’ if
they asked for a later curfew. I
never had to be the bad guy. The
virus was,” Bricken said. “We defi-
nitely got closer.”She just hopes the newfound
awareness her family gained will
stick, going forward.
Me, too.
I look around and see the ves-
tiges of this period: the briefcase
and piles of law books on the floor
on each side of our dining room
table, where my husband, a New
Jersey state government em-
ployee, set up a home “office.” He
will soon be on a schedule where
he will go in some days every
other week. There is still a stick
with a number taped to it lying on
the ground at the park across the
street from my house, a marker
for the miniature golf course
some neighborhood men created
during quarantine, so they could
play every day around sunset.
At one point during the lock-
down we made some funny vid-
eos: In one, I’m dancing with a
raw chicken, to the song, “Happy.”
In another, my son is wearing an
inflatable shark costume and
dancing to the song “Baby Shark.”
It felt like a brief interlude float-
ing in space, like an unexpected
cease fire during war, where all
the muck and fear is momentarily
pushed away. You want it to stay
that way, if only for a few more
moments. But like trying to hold
water back with your hands,
when you take them away, the
water flows right back in, con-
cealing all the gains that were
made.
[email protected]As stay-at-home orders end, I ’ll miss having family in the house all the time
ISTOCK
A mother home-schools her son in his bedroom.“I had quite a few
clients who said,
‘Actually, we’re doing a
little better right now.’ ”
Kelly Moore, clinical psychologist,
on people with social anxieties