The Wall Street Journal - 28.03.2020 - 29.03.2020

A8| Saturday/Sunday, March 28 - 29, 2020 *** THE WALL STREET JOURNAL.

THE CORONAVIRUS PANDEMIC

suppliers began churning out

parts for the ventilators in re-

cent days, the people familiar

with the effort said.

“If you think about what

goes into a vehicle—the air-cir-

culation systems, filtration,

electronics, lots of hoses—a lot

of those types of components

also are contained in ventila-

tors,” said Carla Bailo, presi-

dent of the Center for Automo-

tive Research.

The president has publicly

admonished GM and Ms. Barra

personally several times during

his tenure. Last year he repeat-

edly criticized GM for closing

factories and laying off work-

ers in Midwestern states.

In his series of tweets, Mr.

Trump said GM should reopen

its plant in Lordstown, Ohio, to

make ventilators, “or some

other plant.” GM last year sold

the Ohio factory to a start-up

electric truck maker.

President Trump also

tweeted thatFord Motor Co.

needed to “get going on venti-

lators, fast!!!”

In the past two weeks, sev-

eral auto makers, including

Ford, have disclosed plans to

work with medical-device com-

panies to boost ventilator pro-

duction. Ford this week said it

would work withGeneral Elec-

tric Co. to increase ventilator

supply but didn’t offer specif-

ics.

Toyota Motor Corp. said

Friday that it is finalizing

terms with two ventilator mak-

ers to help increase their ca-

pacity.

The president said later Fri-

day that the administration

A ventilator is shown at the Jacob K. Javits Convention Center in New York this past week.

ANGUS MORDANT/BLOOMBERG NEWS

ity in Bothell, Wash.

The most severely ill pa-

tients infected with the new

coronavirus have such trouble

breathing that they are put on

a ventilator, an invasive ther-

apy that involves inserting a

tube into the patient’s wind-

pipe.

People involved in GM’s ef-

forts said Ventec hadn’t made

a firm commitment to deliver a

specific number of ventilators,

but rather provided the admin-

istration with a range of poten-

tial production volumes that

would scale up to gradually

starting in April.

With hospitals in some ar-

eas experiencing a surge in

Covid-19 patients, the Trump

administration wanted a faster

ramp up to meet the urgent

need, a White House official

said.

GM, and other car compa-

nies that have moved to help

boost the ventilator supply

don’t plan to retool their exist-

ing vehicle-assembly plants to

produce the devices. Instead,

they are lending their expertise

in supply-chain management,

purchasing and manufacturing

to help other medical-device

makers boost output. In GM’s

case, this meant establishing a

new manufacturing line at its

electronic-parts factory in Indi-

ana.

GM said about 1,000 em-

ployees would work on the

project and that the company’s

resources would be donated

“at cost.”

Some of GM’s auto-parts

was working to sign contracts

with more than a half-dozen

other companies, including

General Electric,Philips, Ham-

ilton andMedtronic

He said the administration

had deals in place to collect

100,000 ventilators within 100

days. Speaking to reporters at

the White House, Mr. Trump

said he was skeptical that the

U.S. would need as many venti-

lators as the administration

was collecting, adding that he

may send any surplus to other

countries. To underscore the

point, he said he spoke to the

U.K. Prime Minister Boris

Johnson, who tested positive

for the virus, and asked how

his British counterpart was do-

ing. Mr. Johnson told him: “We

need more ventilators.”

TeslaInc. Chief Executive

Elon Musk has said he is work-

ing with medical device-maker

Medtronic and has said the

auto maker’s New York solar

panel factory “will reopen for

ventilator production as soon

as humanly possible.” He also

said he acquired ventilators

from China and has been work-

ing to deliver them in the U.S.

On Friday, Mr. Musk said on

Twitter the biggest value Tesla

was providing was precise de-

livery of ventilators to the in-

tensive care units that need

them most.

“There are many ventilators

in warehouses, but stuck in lo-

gistics/routing/paperwork is-

sues,” he wrote.

—Tim Higgins

contributed to this article.

Systems.

On Friday, the Detroit auto

maker said, “Ventec, GM and

our supply base have been

working around the clock for

weeks to meet this urgent

need.”

The president had criticized

GM and its leadership earlier

Friday, saying in a series of

Twitter posts that the com-

pany had initially said it could

supply 40,000 ventilators, but

then later said it could make

only 6,000 available by late

April. In one of his Friday

tweets, the president criticized

GM Chief Executive Mary Barra

as “always a mess.”

White House officials said

the two sides had been dis-

cussing a contract worth about

$1 billion, but the talks broke

down over the timeline for de-

livering the devices.

Earlier Friday, after the

president’s Twitter posts, GM

and Ventec said they aimed to

produce as many as 10,

ventilators a month, in part

through a new assembly line

being set up at a GM facility in

Indiana. Closely held Ventec

normally makes a few hundred

ventilators a month at its facil-

ContinuedfromPageOne

GM Told

To Ma ke

Ventilators

When the U.S. government

barred family members from

visiting relatives in nursing

homes, it made an exception

for “end of life situations”—

setting off a painful, nation-

wide debate about the mean-

ing of the phrase.

The Centers for Medicare

and Medicaid Services issued

the order on March 13 to pro-

tect nursing-home residents

from the coronavirus after

dozens of them died in facili-

ties across the country.

Many families see the pol-

icy as a painful but necessary

step to protect the elderly and

ill. But it has been hardest on

those who fear their loved

ones have just days to live, say

families and nursing home of-

ficials.

Some 1.4 million elderly and

disabled adults live in more

than 15,000 nursing homes,

according to U.S. government

data. Stanford Medical School

estimates that about 20% of

Americans end their days in

nursing homes.

Sherry Culp, who works at

the Nursing Home Ombudsman

Agency of the Bluegrass in

Kentucky, fields calls from pa-

tients and families and commu-

nicates their issues to facilities.

“The biggest concern that

we are hearing from family

members is that they have a

resident in a nursing home

who they think is ‘end of life,’

but they are having trouble ac-

cessing the resident for in-

person visits,” she said.

“There is some confusion

about what is ‘end of life,’”

said Ms. Culp.

The government directive

didn’t define the phrase, and it

left some delicate questions

unanswered: How long before

death should visits be al-

lowed? How many relatives

can visit? What safety proce-

dures should be adopted to

protect other residents?

Last week Ms. Culp got a call

from an 86-year-old man who

worried he would be turned

away from the nursing home

where his wife was receiving

hospice care. Ms. Culp assured

him he had the right to visit

because his wife was dying.

Kentucky and some other

states, responding to pleas

from anguished families who

wanted to visit dying relatives,

have drawn up their own

guidelines and definitions of

end of life. “This includes any

resident who is receiving hos-

pice care, not just a resident

who is facing imminent death,”

the Ohio Department of Health

wrote in a memo to nursing

home administrators last week.

That memo came too late

for Joe Race, an Ohio trade as-

sociation executive, whose 87-

year-old mother, Bernadine

Raicevich, was dying of ovarian

cancer. When her condition de-

teriorated earlier this month,

Mr. Race called seven hospices.

All said they would take her

but that family members

wouldn’t be allowed to visit.

So he and his four siblings

kept her home near Cleveland

and took turns caring for her

around the clock, even though

they felt she would have bene-

fited from professional pallia-

tive care. Mrs. Raicevich, a re-

tired nurse, died peacefully

this past Sunday, with one of

her daughters by her side.

“I want to be a team player,

but I wish they had fewer re-

strictions for people at the end

of their life,” Mr. Race said.

“Take my temperature at the

door, put me in hazmat cloth-

ing. I’d gladly wear it and go

see my mom,” he said. “I don’t

think it’s too much to ask.”

In Kentucky, Gov. Andy

Beshear said in a statement

last week that families should

be notified “several days and

up to one week in advance of”

a substantial change in a pa-

tient’s condition, but didn’t

specify how that should be de-

termined. “Providers should

not wait until active dying.”

At Jordan Center in Louisa,

Ky., nursing home officials

called families of its nearly

100 residents to ask how they

felt about the coming ban on

visits. All but five families said

they were supportive. Two de-

cided to take their residents

home, and others initially re-

fused to heed the ban, accord-

ing to David McKenzie, Jordan

Center’s administrator.

Among them was an 82-

year-old woman who visited

her husband with dementia

every day, arriving before

breakfast and leaving after

dinner.

“It was heartbreaking,” Mr.

McKenzie said. “I can’t even

imagine what it would be like

to be separated from your

spouse after being together

for67years.”

Mr. McKenzie met with the

woman twice and convinced

her to accept the ban. She now

speaks with her husband via

video calls.

Kathleen Heren, an om-

budsman at the Alliance for

Better Long-Term Care in

Rhode Island, has to improvise

when advising facilities be-

cause the state hasn’t issued

guidance.

She recommends that facili-

ties have family members visit

“toward the end,” when hos-

pice nurses see signs of immi-

nent death, rather than at the

start of hospice care.

Just one or two family

members should be allowed in

at any time, she said.

“It’s really a case of com-

mon sense,” Ms. Heren said.

“There is no set answer to

anything.”

BYYUKAHAYASHI

Nursing Home Visitor Ban

Raises Difficult Questions

Defining ‘end of life’

to allow people to see

dying loved ones is

being widely debated

Bernadine Raicevich when she

attended nursing school.

VIA JOE RACE

The world-wide spread of

the new coronavirus is throw-

ing into disarray studies criti-

cal to the development of

promising new medicines.

The pandemic is causing de-

lays in starting clinical drug

trials and temporarily halting

others, according to companies,

consultants and industry offi-

cials. Patients enrolled in some

studies have stopped showing

up at trial sites, while hospitals

the were seeing trial subjects

are shifting attention to tack-

ling coronavirus patients.

Industry scientists, mean-

while, can’t travel for research.

“Things are just getting

canceled left and right,” said

Christian Burns, president of

ClinEdge LLC, which helps

drug companies recruit drug-

trial participants in more than

30 countries.

The disruptions, which

aren’t affecting research into

coronavirus drugs and vac-

cines, mean it could take lon-

ger for new drugs aimed at

treating conditions like diabe-

tes and liver disease to reach

patients, if the medicines even-

tually prove to work safely.

Company revenue could

suffer, too, if future sales of

drugs are deferred because of

trial delays.

The drug studies most af-

fected are in heavy-hit regions,

such as Italy, China and South

Korea, where lockdowns have

restricted the ability of pa-

tients to leave their homes,

enroll in trials and travel to

study sites to get experimental

treatments, industry officials

say. Studies in the U.S. are

also starting to feel an impact.

Bristol-Myers Squibb Co.

and Eli Lilly & Co. said this

week they will hold off start-

ing most new trials, citing

safety concerns. Bristol is also

temporarily halting infusions

of experimental cellular thera-

pies under study, while Lilly

said it would pause enrolling

new study subjects for trials

already under way. Pfizer Inc.

said Wednesday it is suspend-

ing recruitment of patients for

most new and ongoing studies

that don’t involve life-threat-

ening conditions.

Trials play a pivotal role in

the introduction of new medi-

cines. Regulators rely on the

results to gauge whether an

experimental drug is safe and

works, and should be approved

for use. Companies can spend

tens of millions of dollars to

carry out a single study.

Many current drug trials

for critical ailments are ex-

pected to continue, though,

because hospitals and drug-

makers view them as crucial

for patients. Moreover, pa-

tients testing drugs for fatal

or critical conditions such as

cancer are motivated not to

skip treatments.

The pandemic, though,

threatens to delay research

into much-needed treatments

for other critical conditions.

Nearly two-thirds of 170

clinical trial sites surveyed in

the U.S. believe patients will

be much less or somewhat less

likely to enroll in new clinical

research trials due to the cor-

onavirus, according to a re-

view last week from consul-

tancy Continuum Clinical. And

nearly half the sites expect pa-

tients enrolled in trials to be

much less or somewhat less

willing to keep participating.

“That’s where this could be

really damaging,” said Contin-

uum President Neil Weisman.

“If too many patients discon-

tinue with a clinical trial,

pharma companies aren’t going

to have enough data to prove

their products hit an endpoint

and show their drug does what

they hope it would do.”

The Northwell Health sys-

tem on Long Island, N.Y., has

paused about 50 clinical trials

to protect patients and free up

more than 40 staffers for cor-

onavirus drug research. “Right

now, I’m prioritizing,” said

Kevin Tracey, president of

Northwell’s Feinstein Insti-

tutes for Medical Research.

Arrowhead Pharmaceuticals

Inc., which is based in Pasa-

dena, Calif., last week sus-

pended enrollment in a liver-

disease trial for at least four

weeks because the study

needs patients who are at risk

for coronavirus infections and

who must get a liver biopsy,

which requires visiting a

clinic, said Chief Executive

Christopher Anzalone.

“There’s probably some

type of disaster-planning go-

ing on in every single com-

pany,” said Laurie Halloran,

chief executive of Halloran

Consulting Group, which ad-

vises firms on clinical trials.

To keep trials moving for-

ward despite the virus, some

drugmakers are trying to

transfer to patients’ homes the

work typically done at re-

search sites.

Scynexis Inc., of Jersey

City, N.J., is directing patients

in a trial for its experimental

fungal treatment to have blood

drawn at home or alternative

sites, and to receive the drug

at home, after some patients

missed appointments in Italy

and other European countries,

said Chief Executive Marco Ta-

glietti.

BYJAREDS.HOPKINS

Non-Coronavirus

Drug Testing

Is Interrupted

The crisis threatens

to delay research into

treatments for other

critical conditions.

Bernadine Raicevich surrounded by her children, who decided to care for her at home until her death in Cleveland this past Sunday.

VIA JOE RACE