FRIDAy, MARCH 27 , 2020. THE WASHINGTON POST EZ RE A
the coronavirus pandemic
The attention by political lead-
ers a lso has contributed to runs on
supply and hoarding, which New
York and other states have tried to
block with executive orders re-
stricting p rescriptions.
New York w ill use three medica-
tions — hydroxychloroquine and
chloroquine in combination with
the antibiotic azithromycin —
contributed by the federal Emer-
gency management Agency and
Amneal Pharmaceuticals, the
state said. The first wave of pa-
tients will receive hydroxychloro-
quine a nd azithromycin.
Launching such a plan “is
something that normally would
have been done in six to nine
months and w e’re doing it in three
or four days,” a New York state
health official, who spoke on the
condition of anonymity to discuss
evolving plans candidly, s aid in an
interview Wednesday.
Patient outcomes from the ex-
periment will be gathered elec-
tronically and contribute to an
“observational” t rial being coordi-
nated by the government, the offi-
cial said. In an observational trial,
which is considered less rigorous
than a controlled trial comparing
a treatment with a placebo, re-
searchers see if a therapy is safe
and effective by gathering and
comparing the results in a large
database.
In addition to mortality and
overall recovery, the study will
measure patients’ overall viral
load, duration on a ventilator and
number of d ays in the h ospital.
The fDA would not comment
on any aspects o f the massive New
York experimental effort, citing its
own c onfidentiality rules.
Ground-level hospital adminis-
trators are scrambling to set up
the reporting programs so out-
come data from patients treated
with the drugs can be reported
back to the state and federal au-
thorities.
“I have never s een a nything like
this. It i s amazing h ow the c ountry
and everybody can pull together
and come up with quick, innova-
tive ways to try to attack it,'” said
onisis Stefas, chief pharmacy offi-
cer for Northwell Health, which
has 22 hospitals in New York and
has already been using the anti-
malarial d rugs t o treat p atients on
a “compassionate-use” b asis.
“Everybody’s questioning it,
and that’s why these studies need
to be done to confirm it,” he said.
“There aren’t a lot of other options
out t here.”
The initiative is freighted with
equal parts hope and politics,
which some health-care officials
and states suggest are eclipsing
science.
drugs from A
Nevada, via executive order,
this week banned prescriptions of
the d rugs for t he coronavirus until
the results of rigorous clinical tri-
als a re known.
“We must deal with facts, not
fiction,” N evada’s chief s tate medi-
cal officer, Ishan Azzam, said. Ne-
vada is among states trying to s top
runs and hoarding that have de-
pleted supply f or people who need
the treatments for established
uses, i ncluding l upus patients.
N ew York’s Cuomo has also l im-
ited new prescriptions of the anti-
malarial drugs to patients with
previously approved fDA condi-
tions and to coronavirus patients
participating in state-sponsored
experiments.
Despite some tantalizing early
results, there is scant published
evidence that the two anti-malarial
drugs will have a benefit for coro-
navirus patients. more rigorous
controlled clinical trials are being
conducted in New York and minne-
sota, and around the world. Antho-
ny S. fauci, head of the National
Institute for Allergy and Infectious
Diseases, has repeatedly cau-
tioned, from the same White House
lectern as Trump, that indications
of benefit so far are anecdotal.
But in the absence of viable
alternatives, there h as been a glob-
al rush to try the drugs. Doctorsand h ospitals have virtually wiped
out U.S. supplies by prescribing
them “off l abel.”
The low-cost generic pills have
been on the market for d ecades for
malaria, l upus and r heumatoid ar-
thritis. many experts have said
they believe they are relatively
safe, although hydroxychloro-
quine can cause dangerous heart
problems and some specialists
recommend electrocardiogram
screening tests, especially when
used in c ombination with azithro-
mycin. The mayo Clinic issued a
warning Wednesday that doctors
need to determine which patients
are at risk of potentially fatal ar-
rhythmia before they prescribe
the d rugs.
“Correctly identifying which
patients are most susceptible to
this unwanted, tragic side effect
and knowing how to safely use
these medications is important in
neutralizing this threat,” said mi-
chael J. Ackerman, a mayo Clinic
genetic cardiologist. The drugs
also can cause permanent eye
damage called retinopathy that
can lead to vision loss and blind-
ness.
The fDA’s quick a ction on large-
scale observational trials was
spurred by Trump’s sudden inter-
est in the anti-malarial drugs. As
fauci and others urged caution,rep. mark meadows (r-N.C.),
Trump’s incoming chief of staff,
contacted a family doctor in Up-
state New York w ho claims to have
used them to successfully treat
hundreds of suspected covid-
cases.
Vladimir “Zev” Zelenko, a doc-
tor in monroe, N.Y., said in an
interview that he was contacted b y
meadows a fter p osting a n unsolic-
ited video message to Trump on
facebook in which he told the
president: “Please advise the
country that they s hould be taking
this medication.”
The doctor also published an
open letter on Google Docs to fel-
low medics outlining a treatment
plan of recommended doses,
which was picked up by conserva-
tive media.
Zelenko said that over one call
and several text messages, mead-
ows was “very kind and receptive”
and told him his treatment plan
was b eing evaluated a t high levels.
A person close to meadows, who
like others spoke on the condition
of anonymity to candidly discuss
internal deliberations, confirmed
the two had been in touch this
week about the drugs, and said
White House experts were evalu-
ating the plan.
Another official s aid Trump saw
Zelenko’s treatment plan on tele-vision and flagged it in the White
House.
Sean Hannity, the fox News
host and informal Trump adviser,
read from Zelenko’s open letter
during a telephone conversation
with Vice President Pence that
aired on his prime-time show
monday evening. r udolph W. G iu-
liani, the president’s personal at-
torney, championed Zelenko’s
treatment plan on Twitter the fol-
lowing morning.
Since the start of the coronavi-
rus outbreak, Zelenko, 46, has
shared material on facebook sug-
gesting that the virus may have
been deliberately developed by
China as a population control de-
vice and that its threat was exag-
gerated by Democrats.
Zelenko acknowledged the
drugs could have side effects.
“They’re not candy,” he said.
“However, this is an unprecedent-
ed health crisis, the world’s under
attack, this is battlefield medi-
cine.”
Supporters o f using anti-malar-
ial drugs against the coronavirus
have cited several published stud-
ies using small patient groups in
france, Japan and China. Some
other equally small analysis has
suggested there is no benefit.
A fter Trump expressed his sup-
port for the drugs last week, Cuo-mo announced Sunday that
70,000 doses of hydroxychloro-
quine and up to 750,000 doses of
chloroquine a re i n the p ipeline for
New York’s p atients.
“There’s a good basis to believe
they could work,” Cuomo said
Sunday.
Although the s cale and urgency
of New York’s efforts are new, try-
ing unproven drugs on patients
who otherwise might die is com-
mon in American health care for
cancer and r are diseases. The fDA
has the power to grant such “com-
passionate-use” permission, both
on an individual basis and under
blanket protocols for larger popu-
lations, specialists s aid.
Drug manufacturer Gilead Sci-
ences has said it is working with
the f DA t o develop a new, b roader
program of c ompassionate use f or
its experimental antiviral drug
remdesivir.
“on this scale, I think it is un-
precedented. I have never seen
anything like this,’’ said Dianne
Bourque, a lawyer specializing in
fDA rules at the firm mintz. “We
are s eeing an explosion o f compas-
sionate-use requests and I think
that’s a factor of many of our cli-
ents trying desperately to find
anything that works for desper-
ately ill p eople right now.
“People are throwing every-
thing at t his,’’ s he said.
The fDA is working quickly to
accommodate such requests,
Bourque added.
The fDA is clearly reacting to
pressure from Trump and t he g en-
eral public, who are clamoring for
some sort of treatment, said Ali-
son Bateman-House, a professor
of population health at New York
University and a specialist i n com-
passionate-use programs. She
said the fDA is doing the best it
can to balance competing inter-
ests i n a time o f crisis.
“It is very dangerous to take
your medical advice from some-
one w ho d oes not actually practice
medicine,” she said of Trump’s
boosterism statements about the
drugs. Ye t, she said, there is some
reason to believe the treatments
could have a beneficial effect, so
large-scale compassionate-use tri-
als c ould be a ppropriate.
“The fDA is caught between
saying it wants good science, and
good processes, and what evi-
dence-based medicine requires,”
she said, “and this is what our
bosses, the people and the presi-
dent are telling us they want.
“Sometimes safeguarding the
public health... is not what the
public wants at a given moment,”
Bateman-House said. “They want
unfettered a ccess.”
[email protected]
[email protected]
[email protected]Unproven treatment touted by Trump is being tested on thousands in New York
DEMETRIUS FREEMAN/BLOOMBERG NEWS
Workers pack protective masks in Brooklyn. In New York, the u.s. epicenter of the covid-19 pandemic with more than 37,000 infections,
health officials are authorizing a plan to treat seriously ill patients with the anti-malarial drugs hydroxychloroquine and chloroquine.BY SUSAN SVRLUGAone day they were surfing be-
tween classes, one of the perks of
studying abroad on the coast of
Peru. Then the country’s presi-
dent declared a state of emergen-
cy, shutting the borders and im-
posing a quarantine.
“The teachers told us we had to
make it to the next town by
curfew,” said Zoe Lynch, 17, one of
the students from the Traveling
School, a study abroad program
for young women. “We saw this
huge military barricade thing.
They did not want to let us in.
That was real.”
The teachers pleaded that they
needed to get to Huanchaco, a
nearby coastal town, to shelter in
place. finally, the soldiers let
them pass — o n foot. They w alked
about 40 minutes to get to their
hostel.
“Things were changing really
fast,” said Isabel Estes, also 17.
They woke to streets empty but
for soldiers and police. They
could see the beach but were not
allowed to go. Everything was
quiet. The borders were sealed.
They were trapped.
That was over a week ago. on
march 16.
“There’s a lot of uncertainty
here,” Lynch said. They want to
return home. But they can’t. “We
don’t know when we’re going.”
Last week, with the spread of
the novel coronavirus pandemic
wreaking havoc around the globe,
the State Department warned
Americans not to travel abroad
and advised those overseas to
return immediately. Closed bor-
ders and canceled flights upend-
ed travel plans and stranded trav-
elers, including American stu-
dents, from teenagers to post-
grads, studying around the world.
many have managed to get
home. A group of university stu-
dents, also stranded in Peru, final-
ly got on a chartered flight from
inland Cusco to Lima on Wednes-
day afternoon and landed in the
United States that night. But that
took the efforts of four university
presidents working with govern-
ment officials. The 19 students
and teachers in Huanchaco, far
from Lima’s international air-
port, are still stranded.
“Everything is happening so
fast,” said Chandra rosenthal,
whose 15-year-old daughter, Kiki,
is among the stranded teens. “It
all started cascading. I expect
that to continue, and I’m worried
for the girls’ safety.”
Zara Ali, a student at Kenyon
College in ohio, wasn’t worried
about the coronavirus when she
left f or a study abroad program in
Buenos Aires on march 1. Back
then, the outbreak seemed isolat-
ed to a few places in Asia and
Europe.
When it became clear the dis-
ease was spreading, her host fam-
ily tried to talk her out of leaving.
Conditions were worse in New
York, they said, and the travel
home to Brooklyn could expose
her to more risk. But flying was
only becoming more fraught, so
she booked a flight home after
less than three weeks. “The worry
we all had was just getting stuck
in Argentina,” she said.
Anna Barr, a student on the
same program, initially chose to
stay, even after university officials
advised students to come home.
When the private program was
canceled outright, she booked a
flight home to michigan for later
that week, only to hear from U.S.
officials that she should go to the
airport immediately.
Her host mom made her mate,
an herbal tea, to calm her down
and advised her in Spanish how
to fold her clothes as she rushed
to pack. She got on the flight, but
it was diverted to Sao Paulo, Bra-
zil, for an emergency medical
situation, and then to San Juan,
Puerto rico, for a crew change,
before finally landing in Atlanta.
“I’m good. Tired, but good,” she
said. “I’m glad to be back in the
U.S.”There were no confirmed cases
of the coronavirus in Peru when
six students from Augusta Uni-
versity in Georgia arrived in feb-
ruary. In the second year of their
program to become physician as-
sistants, the women had gone to
Cusco to provide screenings in a
place with high rates of cervical
cancer. They were living in a
dorm with bunk beds over a
health clinic.
Then they began to hear ru-mors about flight cancellations.
They booked the earliest return
flights they could find. Within an
hour, the president of Peru had
announced the borders would be
closed within 24 hours.
When their calls to the U.S.
Embassy went unanswered, the
students stuffed their clothes into
bags, climbed into taxis and
rushed to the consular agency.
The gates were closed. The
police arrived and told them todisperse, along with the other
frantic Americans who had ar-
rived seeking emergency travel
advice.
They climbed back in the cabs.
But now the driver said he
couldn’t take them to the airport,
because only people with con-
firmed tickets were being allowed
near the terminal.
Back in their dorm, they tried
to think of options. They couldn’t
fly out, and they were too far from
the border to drive out.
A week and a half later, Erin
Hill, one of the students, said they
were hearing there were some
flights to and from Lima. But they
were still unable to get there from
Cusco. They had run out of the
local currency they needed to buy
food. They were running low on
the medicine some of them need-
ed. At last check, the only grocery
store they were allowed to go to
had run out of fresh produce.
“We’re worried about the food
supply,” Nurin Ghazzawi said this
week. They were also worried
about a classmate who is immu-
nocompromised. “It’s very neces-
sary to get out sooner than later.”
Christen Engel, a spokesman
for Augusta University, said the
presidents of the University of
Georgia, the University of South
Alabama, Augusta University and
Lenoir-rhyne University in
North Carolina sent a joint letter
to multiple congressional delega-
tions asking for help with 17 stu-
dents, one faculty member and
one staff member who were un-
able to leave Cusco and Lima.
“We’re just waiting,” Ghazzawi
said earlier this week, “trying to
be as hopeful as possible. We feel
pressed for time.... our biggest
concern is things have changed so
rapidly here, we don’t know what
the future holds as well.”
on Wednesday afternoon, she
sent a message: They had just
touched down in Lima. “Hoping
to be back stateside by tonight.”
It wasn’t long ago, Chandra
rosenthal said, that Peru seemedliked a safer place for Kiki to be
than home in Denver. Colorado
was shutting down, but there
were only a few confirmed cases
in Peru.
But two days after the Travel-
ing School group crossed the bor-
der from Ecuador into Peru, the
Peruvian president announced
the country was closing airports,
shutting down land and air travel,
and imposing a mandatory quar-
antine the next day, said Danika
robison, one of the teachers.
Jennifer royall, the school’s
executive director, said school
leaders had been closely monitor-
ing the outbreak, but with only
four confirmed cases when the
group traveled to Peru, the emer-
gency declaration came as a sur-
prise. “The U.S. Embassy has ad-
vised our school to shelter in
place and await confirmed trans-
port,” she wrote in an email this
week.
School officials are working
with U.S. and Peruvian officials to
try to get the group back to the
United States, robison said, but
they don’t yet know when or how.
“Without a flight,” she said, “we
stay put.”
robison said members of the
military are trying to do their
jobs, enforcing the ban on large
gatherings, but that is creating
difficulties for them because of
the size of their group.
“It’s definitely a little anxiety-
provoking to not know when
we’re leaving,” Estes said. They’re
trying to stay positive even as
they abide by the strict rules of
the curfew. They’re continuing
classes, even mixing in some sci-
ence curriculum on viruses. They
tried to have a dance in the base-
ment but soldiers told them to
turn down the music. Even at
breakfast, when a group of them
was talking too loudly, Lynch
said, they heard a whistle.
“I am packed, I am ready,”
Lynch said. “I am ready the mo-
ment they say, ‘Let’s go.’ ”
[email protected]American students are waiting in limbo a fter Peru closed its borders
DANIKA ROBISON
students and teachers from the Traveling school in Peru. They have
been unable to leave the country due to their remote location.