The Washington Post - USA (2021-12-22)

A10 EZ RE THE WASHINGTON POST.WEDNESDAY, DECEMBER 22 , 2021

BY LENNY BERNSTEIN

Plaintiffs in a federal lawsuit
allege that private emails made
public Monday show that the top
executive of the nation’s organ
transplant system and an adviser
engineered “a drastic policy
change” on “false legal pretenses”
to change the way scarce, valu-
able livers are allocated.
The emails, filed with court
papers, contain disparaging de-
scriptions of those who disagree
with the writers’ approach to allo-
cating organs. The nonprofit
United Network for Organ Shar-
ing, known as UNOS, which oper-
ates the complex U.S. transplant
network, unsuccessfully fought in
court to keep the emails from
becoming public. In November,
an appellate court ordered them
unsealed.
But attorneys for the Depart-
ment of Health and Human Ser-
vices, which oversees UNOS and
the transplant network, coun-
tered that the federal agency —
not the two individuals — made
the final decision on a controver-
sial new plan for allocating the
lifesaving organs.
The filing is part of a lengthy,
bitter dispute about how to fairly
allocate livers from deceased do-
nors, which are in critically short
supply. The larger issue of how to

equitably distribute kidneys, livers, hearts, lungs and other organs to the sickest patients, while accounting for the needs of people in geographic regions, minori- ties and poor patients, has been fought over for years. For decades, transplant hospitals generally had first shot at organs donated in their areas. A policy adopted in December 2018 under pressure from HHS and litigation offers livers to the sickest patients as far as 500 nautical miles from the donor — a much greater distance than allowed by previous rules. The plaintiffs assert that the change allows big-city transplant hospitals in New York, San Fran- cisco, Chicago and elsewhere to reach deep into other parts of the country where the organ shortage is not as severe, taking livers from their patients. But surgeons in urban centers contended that outdated geographic boundaries disadvantaged their patients. They noted at the time that a moderately ill patient in Kansas had a better than 60 percent chance of receiv- ing a liver transplant within 30 days, a similar one in Minnesota had a 6 percent chance and a California patient had a 1 percent chance. There are almost 107,000 peo-

ple waiting for transplant organs in the United States, the fewest since 2009; 11,588 need livers, according to UNOS. In 2o20, 8,906 livers from both deceased and living donors were transplanted. About 40,000 organs were transplanted in 2021. The newly released emails show that in 2017, as the latest debate over liver allocation was occurring, Alexandra Glazier, head of the organization that collects transplant organs in New England, discussed a draft of a letter to a medical journal regard- ing research on the ways the policy would affect people of col- or and those in disadvantaged areas. In an email to Brian Shepard, UNOS’s executive director, she wrote: “I can say ‘the fact that some states do better than others in preventing preventable deaths and providing health care insur- ance coverage and access means you’re a dumb f--- for living there and should immediately write your legislators that you want better social infrastructures’.” Two days before Glazier’s April 28, 2017 email, Shepard wrote to her about similar concerns ex- pressed by some in the transplant community. “This is an infuriat- ingly elitist argument masquer-

ading as concern for the poor. Only people who have means can get transplants. So this isn’t give ‘txs to poor people’ argument, it’s a ‘give txs to those of us who have to live near poor people’ argument.” “Txs” is shorthand for “transplants.” Glazier is executive director of New England Donor Services, which collects organs from donors throughout that region and sends them to hospitals for transplant. She served as chairwoman of the transplant system’s policy oversight committee from July 2019 to June 2021, but was not in that post when she wrote the 2017 email and others in Monday’s filing. I n an emailed response to a request for comment Monday, she wrote: “One email appears to be of special interest to the plaintiffs because I regrettably use an expletive in a flip comment about surgeons who I felt should be more proactive in advocating for equitable access to health care for patients in their home states.” A spokesman for UNOS said in an email the new liver policy “has contributed to greater equity and is saving hundreds more of the sickest patients’ lives since imple- mentation almost two years ago. A few emails nearly five years old have no bearing on these positive

outcomes.” In other emails, Shepard calls a statement from the independent Institute of Medicine “inane” and says separately of an unnamed committee member’s comments: “stupid is so exhausting.” Glazier agreed: “Exhausting,” she wrote back. In total, the plaintiffs in the liver lawsuit contend, the behind- the-scenes discussion in more than 600 pages of emails show two powerful executives working in concert to foist the result they wanted on the voting board of the transplant network. They also allege that Shepard and Glazier manipulated the Health Resourc- es and Services Administration, part of HHS. “Defendants improperly bullied through on false legal pretenses a drastic policy change that was arbitrary, capricious and not otherwise in accordance with law, and that denied plaintiffs due process.” The lawsuit was filed on behalf of four transplant patients and 15 transplant hospitals who assert- ed they would be denied their fair share of the liver supply under the new policy. After legal wrangling before federal and appellate courts, the new policy went into effect in November 2020. A federal judge has previously refused to

halt it while the case continues. Attorneys for HHS — which is also a defendant in the case — said in court papers filed Monday that the agency and members of the transplant system’s board “thoroughly considered all views, including plaintiffs’ and the result is a policy that... is projected to reduce transplant waitlist deaths, promote equitable access to transplants and which was overwhelmingly favored by patients.” They called the idea that UNOS executives bullied a federal agency “absurd.” A Senate committee is investi- gating UNOS and a House sub- committee is looking into “organ procurement organizations,” the 57 nonprofit agencies that collect organs for transplant. Many are failing to meet thresholds estab- lished during the Trump administration to improve their perform- ance. Sen. Ron Wyden (D-Ore.), chairman of the Senate Finance Committee, which is examining UNOS, said in a statement Mon- day the new documents “add to my concerns about the culture and operations at UNOS, all the way to the C-Suite.” A spokeswoman for the House Oversight and Reform Commit- tee declined to comment. [email protected]

Suit alleges bullying tactics in revamp of transplant policy

BY HANNAH KNOWLES

AND PAULINA FIROZI

The omicron v ariant of the
coronavirus has swept the United
States in a matter of weeks,
reshaping a pandemic now head-
ing toward i ts third year and
leading some experts to expect
record-high cases and hospital-
izations.
Scientists are racing to learn
more about this new variant,
which appears more resistant to
vaccines and is even faster-
spreading than the delta variant
that sent infections spiking earli-
er this year. Public health offi-
cials say that getting a booster
shot is the No. 1 thing the vacci-
nated can do to protect against
severe illness and, to a lesser
extent, infections.
But how should omicron fac-
tor into your plans after vaccina-
tion? Infectious-disease experts
give a range of answers.
Some think it’s best to skip the
New Year’s Eve party, as the
country weathers a new wave of
disease. Others underscore that
Americans must “live with the
virus” — especially as vaccines
seems to protect well against the
worst illness but are less effective
at stopping milder cases of omi-
cron.
“The hiding-in-our-basement-
behind-the-pile-of-sandbags mo-
ment has come and gone,” said
Andrew Noymer, associate pro-
fessor of population health and
disease prevention at the Univer-
sity of California at Irvine. “If the
rationale is that there’s covid
outside the door, well we’re going
to be hiding in our basement
forever because there’s going to
be covid next year, and the year
after that.”
“For so many of us — I don’t
necessarily think we need to
cancel plans,” echoed Darlene
Bhavnani, an assistant professor
in the department of population
health at University of Texas at
Austin’s Dell Medical School. “We
can do this safely if we take
advantage of the tools we have.”
Different people, they all ac-
knowledge, will balance the risks
and rewards of each activity dif-
ferently.

Why is omicron different?

Omicron was detected in No-
vember and quickly sparked con-
cerns among scientists. It had a
lot of mutations, some of which
suggested it would evade the
protective antibodies that vac-
cines generate. It also seemed
poised to outcompete delta, the
variant that previously dominat-
ed around the world.
Delta was at least twice as
contagious as the first strain of
the novel coronavirus, scientists
found, while omicron appears to
be at least twice as transmissible
as delta.
California was the first to re-
port a U.S. case of omicron, on
Dec. 1. By the second full week of
December, omicron accounted
for 73 percent of new U.S. corona-
virus cases, according to model-
ing from the Centers for Disease
Control and Prevention.

How well do vaccines and
boosters protect from
omicron?

People who have been vacci-
nated and boosted with mRNA
vaccines from Pfizer or Moderna
will probably be well-protected
from serious illness and death,

researchers said. Even in the face of omicron. A study from South Africa found that the two-dose Pfizer- BioNTech vaccine provided 33 percent protection against infection, far less than for other variants. Protection against illness requiring hospitalization dropped from more than 90 percent against delta to 70 percent, which the researchers said was still “very good.”

How boosters change the pic- ture is not totally clear, scientists said, but the evidence so far is encouraging. Data from the Unit- ed Kingdom showed that a P fizer-BioNTech booster shot re- stored protection against symp- tomatic illness to about 75 percent. Researchers expect boosters to amp up protection against hospitalization, too. The outlook is fuzzier for the minority of Americans who ini- tially got vaccinated with the one-dose Johnson and Johnson shot. The CDC recently recommended mRNA shots over the

J&J vaccine, citing a very rare but potentially fatal blood clot issue. J&J’s shot seems much less potent against omicron infections, researchers have said, but it may still ward off severe disease. People who got J&J and then got boosted should retain signifi- cant protection against serious covid-19, said Arthur Reingold, division head of epidemiology at the University of California at Berkeley. But experts all cau- tioned the data on omicron and various vaccines are still emerg- ing. The hope, Reingold said, is that mRNA vaccines remain “pretty potent in terms of preventing infection. But whether that’s 50 percent or 70 percent or 80 percent, I think we just don’t know yet.” Everyone has to “fathom that none of us is going to live the next 30 years without getting a form of covid some time,” said Noymer. When that happens, experts said, you’ll want to be well-vaccinated.

I’m vaccinated and boosted. Should I still go out to a party? A concert? A restaurant? The vaccinated and boosted should be balancing risk and reward, Noymer said. Ask your- self: Does the enjoyment you’ll get out of a concert, for example, make the chance of infection worth it? Noymer said at this point, he feels comfortable continuing to eat at restaurants. “I would probably be willing to return to only eating at home if the situation calls for it. Before the winter is over, there may be a 4-6 week period I eschew dining out,” he said, but he’s not there yet. Neha Nanda from the Keck School of Medicine at the Univer- sity of Southern California suggested tweaking plans for a New Year’s party to make them more

covid-safe, rather than canceling — maybe by checking that people have gotten boosters or asking people to get rapid-tested just before the event. “Emotional well-being is ex- tremely important,” she said. “At the end of the day, people have to see each other.” Others are being more cau- tious, at least for a while. A. Marm Kilpatrick, a professor at the University of California at Santa Cruz, pointed to science writer Ed Yong’s recent article in the Atlantic: “I Canceled My Birthday Party Because of Omi- cron.” Everyone would have been vaccinated and most would be boosted, Yong wrote. His sense of personal risk had not changed much with omicron. But if the virus spread at his party, it could derail people’s plans to spend Christmas with their families — forcing them into quarantine or exposing loved ones who may be higher-risk for severe illness. Kilpatrick acknowledges that staying home is a luxury out of reach to many. Still, he wants to keep his own contribution to the transmission as low as possible. He also worries about long covid and wants to see more data on it before letting his guard down. He stopped going to indoor dinner parties with friends. He opted not to carpool. He turned down an invite to go see the new Spider-Man film in theaters. “I’m basically just avoiding indoor spaces, you know, with non- household members,” said Kil- patrick.

What if I’m in a high-risk group or worried about infecting a high-risk loved one? Carlos del Rio, a professor at the Emory University School of Medicine, advises people especially vulnerable to the virus —

such as the elderly and immuno- compromised — to avoid gather- ings, even if they are vaccinated and boosted. “I wouldn’t play Russian roulette... omicron’s a different beast. Different ball- game.” “We are in a critical situation that you really don’t want to become a patient in a hospital right now and that you need to do whatever it takes to prevent you from getting infected,” he said. Having an extra-vulnerable person in your household also changes your risk calculus for going out. For those seeing high-risk family members over the holidays, experts recommended testing be- forehand; avoiding activities that could expose you to the coronavirus in the week or two leading up to the visit, if you can; and making sure you travel as safely as possible, wearing a well-fitting mask. Self-testing before an indoor get-together is “especially important before gathering with unvaccinated children, older individuals, those who are immuno- compromised, or individuals at risk of severe disease,” the CDC says.

I’m going out. What precautions can I take? Testing and masking can help you minimize your virus expo- sure. Experts urged against cloth masks, recommending surgical masks or — even better — KN95s. But they said the most important thing is finding a mask that fits your face closely, so that less air escapes out the side. You can also double-mask to boost your protection. Noymer suggested another risk-reward calculation for mask- wearing: There’s no bonus for going unmasked in the mall, he said, but a very good reason to

take them off when you’re dining at a restaurant. Especially in a season of gathering, testing is a critical tool that we “haven’t really had a lot of access to in previous holiday seasons,” said Bhavnani from the University of Texas. If you plan to test ahead of a gathering or event, she suggested doing so “as close to the event as possible.” “I had a group of people here in my house yesterday, a small group of people, but everybody got tested in their car before they came to the house,” del Rio said. Rapid tests that return results in 15 minutes are available in drugstores but many be hard to come by as demand spikes. Un- like slower, publicly-provided PCR testing, they typically cost $20 to $35 per two-pack and are not accessible to everyone — though the Biden administration plans to make more free. Bhavnani recommended testing early and immediately if you are feeling any symptoms, even if you think they may be allergy or flu symptoms. Experts also ad- vise testing five days after close contact with someone who has the virus.

What if I’m a parent of young children who cannot be vaccinated yet? Children under 5 are not yet eligible to be vaccinated. As of mid-December, children 4 or younger accounted for a small fraction of U.S. covid-19 deaths — 236 out of nearly 800,000, or roughly 0.03 of 1 percent, according to the CDC. The virus has proven far more severe for adults, and risks increases with age. Despite that, experts acknowl- edged the real fears that parents have about exposing young children. Covid-19 can be serious at any age. Noting her unvaccinated children, doctor Leana S. Wen wrote in The Post: “My family will still take additional precautions; we won’t dine inside restaurants or bring the kids to unmasked holiday events.” But everyone’s situation is different, she said. Bhavnani encouraged gathering outdoors when possible and recommended testing children as a way to curb spread.

What if I’ve already gotten covid-19? Reinfections seem to be more common with the omicron, according to researchers in South Africa and the United Kingdom, though scientists are still learn- ing more. A small study published this month — which did not look at omicron — suggested that break- through infections in vaccinated people may generate “super im- munity,” as senior author Fikadu Tafesse of Oregon Health & Sci- ence University put it. Despite the lack of omicron- specific data, Tafesse said, “based on the results of this study we would anticipate that break- through infections from the omicron variant will generate a simi- larly strong immune response among vaccinated people.” Tests generally do not tell you what variant infected you. [email protected] [email protected]

Carolyn Y. Johnson contributed to this report.

Experts weigh in on approaching the omicron variant

SETH WENIG/ASSOCIATED PRESS

People wait f or coronavirus tests in New York, which reported more than 22,000 new cases statewide on Tuesday. Modeling from the Centers for Disease Control and Prevention showed the new omicron variant accounting for 73 percent of new cases in the United States.

“For so many of us

— I don’t necessarily

think we need to

cancel plans. We

can do this safely if

we take advantage

of the tools we

have.” Darlene Bhavnani, an assistant professor in the department of population health at University of Texas at Austin’s Dell Medical School

The Washington Post - USA (2021-12-22)

A10 EZ RE THE WASHINGTON POST.WEDNESDAY, DECEMBER 22 , 2021

BY LENNY BERNSTEIN

BY HANNAH KNOWLES

AND PAULINA FIROZI

SETH WENIG/ASSOCIATED PRESS

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