The Washignton Post - 04.04.2020

A4 eZ sU the washington post.saturday, april 4 , 2020

the coronavirus pandemic

BY LENA H. SUN

AND JOSH DAWSEY

President Trump announced
new guidance friday that people
in the U.S. wear face coverings in
public to slow the spread of the
coronavirus, a reversal of the ad-
ministration’s earlier recommen-
dations. But Trump immediately
said he himself would not choose
to do it, even though “it may be
good” advice, reflecting the sharp
debate in recent days between the
White House and the Centers for
Disease C ontrol a nd Prevention.
White House coronavirus task
force officials had debated wheth-
er to recommend universal use of
face coverings s uch as cloth m asks
when people go out in public, or
target the guidance more narrow-
ly to areas with high community
transmission of the virus that
causes c ovid-19.
Some senior administration of-
ficials pushed to limit the recom-
mendation because they argued
that wide use of masks is u nneces-
sary and might cause panic. Some
of the president’s political advis-
ers also warned against recom-

mending masks for everyone, and

had proposed to rewrite the agen-

cy guidance more narrowly, ac-

cording to two senior administra-

tion officials who spoke on the

condition of anonymity to discuss

the guidance. The draft that went

to the coronavirus task force on

friday limited the recommenda-

tion to high-transmission areas,

they said.

But federal health officials, in-

cluding experts a t the CDC, say the

guidance m akes sense only i f prac-

ticed broadly because it would be

an additional way to contain the

virus and prevent communities

with low transmission from be-

coming areas with explosive

spread. The CDC has been recom-

mending widespread community

use since late last week. The task

force restored that original guid-

ance during its meeting friday

after further pushback from pub-

lic health officials, said the admin-

istration o fficials.

Trump agreed to the new guid-

ance but was not enthusiastic

about it, they s aid.

White House officials had been

privately contradicting CDC pro-

posals for everyone to wear face

coverings. The topic was part of

spirited debate in the coronavirus

task force meetings this week and

in oval o ffice discussions with the

president, according to the senior

administration officials.

one of the m ain proponents for

wider mask use has been Scott

Gottlieb, a former food and Drug

Administration commissioner in

the Trump administration who

has been acting as an informal

adviser to the White House and

sometimes talks to Trump and

regularly speaks with administra-

tion officials.

Trump’s remarks at friday’s

briefing also made clear the guid-

ance applied broadly across the

country, with a special emphasis

on those in the most affected ar-

eas. The guidance posted on the

CDC website states: “CDC recom-

mends wearing cloth face cover-

ings in public settings where other

social distancing measures a re d if-

ficult to maintain (e.g., grocery

stores and pharmacies) especially

in areas o f significant community-

based t ransmission.”

The guidance w as u pdated l ater

friday to highlight the word “espe-

cially” i n bold.

The guidance makes clear that

wearing face coverings or cloth

masks is an additional public

health measure to prevent the

spread of the virus, not a substi-

tute for social distancing. Social

distancing o f at l east six feet is still

recommended even when wear-

ing a mask. Guidance a nd internal

memos from CDC emphasize that

a cloth face mask is intended not

so much to protect the wearer but

to help prevent people who do n ot

know they are infected from

spreading of the v irus t o others.

A recommendation for people

to wear face coverings in public

represents a major change in CDC

guidance that healthy people

don’t need masks or face cover-

ings. Internal memos and guid-

ance had previously made clear

the coverings are not medical

masks, such as N95 respirators or

surgical face masks, which are

needed by front-line health-care

workers and are in extremely

short supply. Those must continue

to be reserved, they say.

Separately, U.S. officials are

weighing a plan to distribute r eus-

able cloth masks — not medical

masks — to h ouseholds, starting

with hardest-hit locations, accord-

ing to a federal official involved in

the response and documents

shared with The Post.

The new CDC guidance was

prompted by increasing evidence

that infected people without

symptoms can spread the corona-

virus. S imple cloth m asks that cov-

er the mouth and nose c an prevent

virus transmission f rom such i ndi-

viduals when they are out buying

groceries, when people may come

into closer contact, f or example.

“We now know from recent

studies that a significant portion

of individuals with coronavirus

lack symptoms (“asymptomatic”)

and t hat even those who e ventual-

ly develop symptoms (“pre-symp-

tomatic”) can transmit the virus to

others before showing symp-

toms,” t he guidance states. “This

means that the virus can spread

between people interacting in

close proximity — for example,

speaking, coughing, o r sneezing —

even if those people are not e xhib-

iting symptoms.”

Health and Human Services

Secretary A lex Azar said in a state-

ment that Trump “relied on the

advice of America’s best scientists

throughout this crisis, and that

science-based a pproach d rove our

new guidance around face cover-

ings. W hile w e don’t h ave evidence

that a cloth mask protects you

from acquiring the virus, the sci-

ence suggests it will help prevent

you f rom spreading i t to others.”

many s tate, c ounty and c ity offi-

cials have suggested people

should wear face coverings when

going out in public. The latest

recommendation came from

Pennsylvania Gov. Tom Wolf (D),

who recommended friday that all

people in the state wear a mask

any time t hey leave t heir h omes.

“masks help prevent people

from sharing illnesses,” he said.

“But, they don’t do a great job at

keeping people from getting sick;

and, they’re not foolproof, so it is

critical that our first act is to ask

ourselves if we really need t o leave

our house. If we don’t really, truly

need to leave, then we shouldn’t.”

[email protected]

[email protected]

New face mask guidance comes after White House, CDC debate

new mask for the government’s
response.
“The Halyard contract was part
of an explicit strategy to ensure
we could surge mask production
in the next crisis,” said Nicole
Lurie, who was the HHS assistant
secretary for preparedness and
response under Barack obama.
“Now we’re dealing with the con-
sequences of not having that ca-
pability.”
Halyard said Thursday in a
statement that its work on the
government contract was com-
pleted in September 2018. A
spokeswoman declined to give
additional details.
An HHS spokesperson, who
spoke on the condition of ano-
nymity, t old The Washington Post
that although Halyard’s plans
were feasible, no funding was
available to build the machine.
HHS’s Biomedical Advanced
research and Development Au-
thority, or BArDA, the depart-
ment that solicited the Halyard
design, had a budget of nearly
$1.5 billion for 2020, according to
an HHS report.
Amid the current crisis, the
design remains under consider-
ation, according to the spokesper-
son, who said, “Implementing
this design along with use of more
proven mask manufacturing
techniques are being considered
by a supply chain task force to
reduce N95 shortages.”
In an interview with CNBC last
week, Edward A. Pesicka, chief
executive of Halyard’s parent
company, owens & minor, said
his company had already stepped
up production of masks and other
protective gear to its maximum.
“We are in the process of actu-
ally expanding capacity, b ut that’s
going to take probably five to six
months to make sure that you
have the capability to expand that
capacity,” Pesicka said.
He did not mention the firm’s
work for the government on a
high-speed machine.
Pesicka did not respond to an
email requesting comment.

Making masks quickly

The obama administration
and medical firm Halyard Health
of Alpharetta, Ga., announced the
project to develop a rapid pan-
demic mask production line in
December 2015.
In may 2 018, another firm, ow-
ens & minor of mechanicsville,
Va., bought Halyard’s surgical
clothing business to operate as a
division named o&m Halyard.
on the government side, the
fast-mask project was an initia-
tive of BArDA, a p art of HHS that
is responsible for creating coun-
termeasures against pandemics,
biochemical attacks and other
threats.
Halyard promised in its 2015
statement to design a “one-of-a-
kind, high-speed machine” to
help federal health planners solve
a production problem that had
bedeviled them for years.
officials had long assumed that
a public health emergency would
one day create a huge demand for
the respirator masks known as

halyard from a

No new

masks,

despite

e≠orts

issue in January 2006 as part of a

federally funded study, delivering

its recommendations in a few

months.

Health officials and manufac-

turers, the panel said, should col-

laborate closely to create materi-

als for an N95 mask that could be

used again and again.

“Given the potential duration

of a pandemic, even stepped-up

production and stockpiling of dis-

posable medical masks and N

respirators may not be sufficient

to meet demand,” t he committee

warned.

It n oted a government estimate

that medical personnel would

need 90 million N95s during a

six-week pandemic. The same es-

timate would be cited nine years

later by Halyard Health as evi-

dence that its high-speed mask

machine was needed.

In 2009, another panel, this

time inside the government, also

urged development of masks that

could be used more than once to

meet demand in a crisis.

Working under the name Proj-

ect B.r.E.A.T.H.E. — Better respi-

ratory Equipment using Ad-

vanced Te chnologies for Health-

care Employees — the group as-

signed the highest priority rating

to its recommendation on reus-

ability.

Lewis J. radonovich Jr., who

was then a senior health official at

the Department of Veterans Af-

fairs, led the panel. Now a senior

researcher at the Centers for Dis-

ease Control and Prevention, he

did not respond to a request for

comment.

Howard Cohen, a professor of

occupational safety a t the Univer-

sity of New Haven who also was a

member of the committee, said its

work unfortunately had proved

prescient.

“It is sad, because we really did

see this coming,” Cohen said. “We

saw the shortfall. And there were

a bunch of things that potentially

could have been done and

weren’t.”

[email protected]

for the chance to “demonstrate

our expertise and help make a

difference.”

This week, Burnes, now a se-

nior vice president at Avanos, de-

clined to comment on the design

venture. “I am no longer part of

Halyard and it has been a couple

of years,” he said in an email.

Making a reusable mask

While funding Halyard’s mask

effort, HHS’s BArDA also backed

development of an N95 mask that

could be used by medical person-

nel more than once without risk

of contamination or infection.

In September 2017, the Trump

administration contracted with

Applied research Associates of

Albuquerque to create a proto-

type of a “next-generation respi-

rator,” as the masks are called,

that could be sanitized and re-

used during public health emer-

gencies.

medical personnel tackling the

coronavirus outbreak have said

that because of shortages, they

have had no choice but to reuse

their conventional N95 masks, a

practice that manufacturers warn

could diminish the masks’ effec-

tiveness.

Applied research Associates

has been awarded $4.8 million for

the project so far, according to

public contract records, and re-

ceived an extension in may to

work beyond its 15-month proto-

type development phase.

But that 2019 deal came too late

for the coronavirus outbreak.

“Unfortunately, if the pandem-

ic would have happened next

year, we’d have been in much

better shape,” s aid Brian Heimbu-

ch, principal investigator on the

project for Applied research As-

sociates. “It’s still in progress. It

looks promising.”

It’s been 14 years since experts

assembled by the Institute of

medicine warned of the need for a

reusable mask. The Committee on

the Development of reusable

facemasks for Use During an In-

fluenza Pandemic took up the

York jail, awaiting sentencing af-

ter his february conviction for

trying to extort sportswear firm

Nike.

At the surgical gown trial in the

spring of 2017, a jury found that

Kimberly-Clark and Halyard had

misrepresented the safety of its

microCool-branded surgical

gowns. The verdict is on appeal at

the U.S. Court of Appeals for the

9th Circuit.

In its appeal, Halyard says

among other arguments that

none of the clinics that sued had

suffered any injuries from its

gowns. The firm says that tens of

millions of gowns have been sold

without any reported infections.

Stephen Devereaux, an attor-

ney for Halyard in the case, said in

an email, “The company does not

comment on pending litigation.”

The jury awarded $454 million

in total damages, which Judge

Dolly m. Gee reduced to about

$25 million. Kimberly-Clark and

Halyard are in an ongoing legal

dispute about who should pay the

damages, court records show.

The HHS spokesperson said

Halyard made the department

aware of the case before the mask

machine contract was signed.

Soon after owens & minor

bought Halyard’s surgical cloth-

ing business in 2018, the surviv-

ing firm renamed itself Avanos

medical. Avanos remains based in

Alpharetta but now focuses on

technical medical devices.

Avanos, not o&m Halyard, has

responsibility for the surgical

gown litigation, according to rep-

resentatives of both companies.

raul Damas, an Avanos

spokesman, said of the mask-

making project that “that pro-

gram and capability went to ow-

ens & minor when Halyard sold

its surgical business to them” a nd

that Avanos had “no visibility” on

the project after that.

Lee Burnes, who was a Halyard

vice president for research and

development in 2015, when the

mask project was announced,

said the company had pursued it

about the work.

Brief mentions in HHS budget

requests to Congress for 2020 and

2021 noted the department was

“supporting efforts at Halyard

Health to develop high-speed

manufacturing for surge produc-

tion” of N95 masks.

But in an emailed statement

from o&m Halyard, the company

said: “owens & minor Halyard’s

obligations under that contract

were completed with delivery of a

final design package to BArDA in

September 2018.”

The HHS spokesperson said

references to the Halyard collabo-

ration appeared in recent budgets

because BArDA “requested fund-

ing to build the prototype” but did

not get enough money for it.

As of friday evening, the

spokesperson had not answered a

question about whether the

shortfall reflected a congressio-

nal decision or was a consequence

of shifting priorities within HHS.

When the pandemic mask proj-

ect launched in 2015, Halyard was

facing legal action over some of its

protective medical gear.

A group of hospitals and clinics

roughly a year earlier had sued

the firm and its former parent

company, paper and medical gi-

ant Kimberly-Clark, alleging

fraud in the marketing of surgical

gowns.

Among other disclosures dur-

ing the class-action lawsuit in Los

Angeles, one Kimberly-Clark em-

ployee was found to have said in

an email that the process used to

seal the seams on the gowns was

“crap,” c ourt filings show.

Company executives rejected

that characterization of the pro-

duction process in their testimo-

ny and maintained that the

gowns were of high quality.

The lawsuit was filed by a then

relatively unknown attorney: mi-

chael Avenatti.

Avenatti would go on to find

fame representing adult-film ac-

tress Stormy Daniels in high-pro-

file legal fights against President

Trump. Avenatti now is in a New

N95s. But the difficulty of predict-

ing when a pandemic or other

crisis would strike meant stock-

piled masks could pass their expi-

ration dates while sitting on

shelves.

Halyard said its new machine

would provide a just-in-time in-

ventory alternative and avoid

waste by enabling rapid and plen-

tiful production when a crisis hit.

“Pandemic preparedness in the

United States is imperative to pro-

tecting health and saving lives,

and respirator manufacturing ca-

pacity remains a critical gap in

that preparedness,” robin robin-

son, then the director of BArDA,

said in a statement at the time.

HHS officials said in a strategy

document that they hoped the

machine would produce at least

1.5 million masks per day — 10

times the output manufacturers

were each then telling the govern-

ment they could do.

Asked whether the machine in

its design could have accom-

plished the 1.5 million daily rate,

Halyard said in a statement that it

submitted a plan “to meet the

requested specifications.” The

HHS spokesperson said, “The

project successfully demonstrat-

ed the feasibility of the approach

and developed an initial design of

a high-speed mask manufactur-

ing line.”

No details of progress in the

Halyard mask project appear to

have been publicly reported by

the government.However, in may

2017, HHS signed off on a

$3.3 million payment to Halyard

as part of the machine project,

according to federal contracting

records.

A Halyard employee involved

in the project told The Post that

the firm delivered the design to

the government on time in 2018

and within the government’s

$5 million budget. outside con-

tractors and engineering firms

were brought in, according to the

manager, who spoke on the condi-

tion of anonymity because he was

not authorized to talk publicly

Matt Mcclain/the Washington Post

a rider wears a mask on a Metro train Thursday. Expert panels have advised the government for at least 14 years that reusable masks are vital.