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| DATE | 2020-12-20 |
| FROM | Ruben Safir
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| SUBJECT | Subject: [Hangout - NYLXS] Treatment Failure
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wsj.com
Opinion | Why Are Covid Antibody Drugs Sitting on Shelves?
Scott Gottlieb and Mark McClellan
6-8 minutes
Discarded doses of the Pfizer-BioNTech Covid-19 vaccine at Helen Keller
Hospital in Sheffield, Ala., Dec. 17.
Photo: Dan Busey/The TimesDaily/Associated Press
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The Friday approval of a second Covid vaccine is welcome news, but much
of the public won’t be able to get inoculated for many months.
Meanwhile, the best way to reduce suffering and hardship is therapeutic
technologies like antibody drugs. But right now, many of these drugs are
languishing on shelves at hospitals and not reaching patients.
Moncef Slaoui, who runs Operation Warp Speed, said recently that more
than 80% of the available supply is sitting unused, even as hospitals
are inundated with critically ill patients. Antibody drugs infuse
patients with synthetic versions of the kinds of immune cells developed
in response to an infection. Early trials show antibody cocktails can
stop Covid symptoms from progressing. They can be used with or without
vaccines for patients at highest risk of severe disease.
The supply is limited. The two companies with authorized versions, Eli
Lily and Regeneron, will ship a little more than one million doses by
the end of the year. Evidence suggests that for every 10 high-risk
patients treated, one hospitalization might be avoided. That may sound
modest, but it adds up: a million doses administered could translate
into 100,000 fewer hospitalizations. Such a reprieve would help
hospitals keep up with the current surge.
The biggest difficulty is logistical. Patients need to be referred for
antibodies soon after diagnosis. The infusion takes several hours to
prepare, deliver and monitor. A specialized nurse must supervise, with
protective equipment, in a space separate from other patients to
minimize spread.
Most early doses have been going to hospitals. But many hospitals are
strapped by Covid and having a hard time setting up dedicated space and
redirecting trained nursing and support staff. The government should
send more antibodies to community infusion centers and clinics that have
taken steps to administer doses. These clinics can work with testing
sites to speed referrals.
Maryland has helped establish infusion-ready sites in each region and is
educating providers on how to refer patients. Most health insurers have
set up payment mechanisms based on Medicare’s approach to reimburse for
the service. But this may not be sufficient, particularly for home
infusion of nursing-home residents and other hard-to-reach patients.
Health plans could enter specialized contracts with home-infusion
providers to create more predictable capacity to treat such patients.
Operation Warp Speed is funding a pilot program to provide infusions in
nursing homes and patients’ homes in seven cities. But the scale is
small. Medicare should also pay providers more for counseling a patient
who tests positive, since treatment has improved beyond merely telling
people to isolate. Counseling could help ensure timely referrals to
antibody treatment when appropriate.
Another obstacle is the limited evidence about the drugs. Some doctors
aren’t convinced they have any benefit. Each emergency authorization was
based on a single study of moderate size. This isn’t unusual in a
public-health emergency, especially for a drug intended for high-risk
patients. But both approved antibody treatments work similarly and the
totality of the evidence seems to show compelling effects, reinforced by
evidence that the coronavirus can be effectively neutralized by
antibodies. Evidence is also growing that the drugs are relatively safe.
There are ways to build on the available evidence. First, since the
antibodies are in limited supply, states such as Colorado have set up a
system to randomize who gets doses if supply runs short. That and
similar systems are opportunities to gather more evidence on patient
outcomes.
Many large health systems and insurers are tracking their Covid
patients; if the antibody effects turn out to be as significant as
suggested in trials, it should show up in analyses using this data.
These studies could also help zero in on which patients are most likely
to benefit and assess the best ways to provide treatments, especially to
underserved populations.
The latest Covid trends are miserable, and it’s too late to stamp out
this surge. But there’s still time to save lives and help contain Covid
from now on—by making aggressive use of both vaccines and antibody
treatments now entering the market.
Dr. Gottlieb is a resident fellow at the American Enterprise Institute
and was commissioner of the Food and Drug Administration, 2017-19. Dr.
McClellan is the director of the Duke-Margolis Center for Health Policy
at Duke University and was FDA commissioner, 2002-04. Dr. Gottlieb
serves on the boards of Pfizer and Illumina and Dr. McClellan on the
boards of Johnson and Johnson and Cigna ; each company is involved in
aspects of the Covid response.
WSJ Opinion: The New Covid Resistance
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2:55
WSJ Opinion: The New Covid Resistance
WSJ Opinion: The New Covid Resistance
Wonder Land: Business owners are pushing back against extreme Covid-19
restrictions, largely in liberal states such as New York and California.
Images: Shutterstock/Reuters Composite: Mark Kelly
Appeared in the December 21, 2020, print edition.
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