Covid Patients Suffer as the Biden Administration Tries to Practice Medicine
By Joel Zinberg, Feb. 7, 2022, wSJ

The Biden administration seems to think it knows better than
physicians how to practice medicine. But its haphazard micro-
management of monoclonal antibodies to treat Covid-19 has created
supply shortages, spread confusion, probably harmed patients,
and undermined future treatment.

The FDA granted emergency-use authorizations for 3 monoclonal-
antibody preparations to treat Covid patients who have mild to
moderate symptoms and are at high risk of progressing to severe
illness. These authorizations covered one treatment developed by
Regeneron, one from Eli Lilly and one from GlaxoSmithKline. These
lab-made proteins provide antibodies to fight Covid faster than
our bodies can make them, which reduces the risk of hospitalization
and death.

The FDA originally directed manufacturers to provide supplies to
the federal govt for distribution to hospitals nationwide. The
govt eventually allowed facilities to order doses directly. But
on Sept. 13 the Health and Human Services Dept reasserted federal
control, citing a surge in Covid cases, and allocated monoclonals
to the states rather than allowing hospitals to order doses directly.

At the end of November, as Omicron arrived in the U.S., the federal
govt paused shipments of GlaxoSmithKline’s medication, sotrovimab,
and increased shipments of the more readily available Regeneron and
Eli Lilly products. The action seemed contrary to concerns that the
more than 30 mutations on the variant’s spike protein would impair
the Lilly and Regeneron monoclonals’ effectiveness. Sotrovimab, in
contrast, targets a different, less mutable part of the spike protein
and was thought to be more likely to retain activity than the other antibodies.

HHS danced around why it did this. The agency initially told one
biopharma industry reporter in mid-December that the sotrovimab
pause was unrelated to Omicron and was taken because of a surplus
of the Lilly product, but then backtracked a few days later, telling
the reporter the decision was driven by the variant. When HHS finally acknowledged that sotrovimab was effective against Omicron and resumed shipments on Dec. 17, it still claimed the monoclonal was withheld to “ensure a more balanced portfolio of monoclonal antibody products and
to allow more time to assess data regarding the effectiveness of
sotrovimab against the Omicron variant.”

Yet there were indications in early December that sotrovimab retained
better effectiveness against Omicron than other monoclonal antibodies.
As the above-mentioned reporter observed: “the about-face from HHS on
why it was withholding sotrovimab reveals an agency scraping to turn
a mAb [monoclonal antibody] shortage into a positive story about how
it planned ahead.” Sotrovimab had been authorized in May but the govt
only had about 50,000 doses on hand by December. When HHS finally
resumed shipments it said they were expected to arrive in local
jurisdictions “as early as Tuesday, December 21, 2021.” By the week
of Dec. 21, Omicron already accounted for more than 70% of cases
nationwide.

HHS then altered its course again on Dec. 23, pausing distribution
of the Regeneron and Lilly products, conceding that they were
ineffective against Omicron. Eight days later, acknowledging “the significant variability in prevalence of the Omicron Variant” around
the country, the dept resumed Lilly and Regeneron shipments.

In a final flip-flop, late last month the FDA withdrew its emergency-
use authorizations for the Lilly and Regeneron antibodies, making
them unauthorized for use anywhere in the U.S., because of the
widespread predominance of Omicron. The agency offered assurances
that if in the future patients “in certain geographical regions are
likely to be infected or exposed to a variant that is susceptible to
these treatments, then use of these treatments may be authorized in
these regions.”

But it’s unlikely the agency will react quickly or effectively.
At the FDA’s current pace, afflicted regions can expect antibody
shipments weeks after the need arises. Information that the Lilly
and Regeneron preparations are less effective than sotrovimab against
Omicron was available for more than a month before the agency acted.
The FDA finally changed course almost two weeks after the Omicron
wave had peaked.

The govt can’t realistically expect Lilly & Regeneron to continue
producing treatments they can’t sell. If another potent variant
appears or Delta—against which the Lilly and Regeneron drugs are effective—has a resurgence, the drugs will likely be unavailable
for a long time even if reauthorized.

The dizzying turns the Biden administration took on monoclonals
shows just how little it trusts physicians & local health officials.
Yet local officials and providers are more likely than Washington
bureaucrats to be aware of the variants and effective treatments
in their region.

New York’s Mount Sinai Hospital system, for example, suspended
infusions of the Lilly and Regeneron products on Dec. 19 because
of Omicron, without any apparent govt instruction and 4 days before
the federal distribution pause.

Regulating the practice of medicine is outside the FDA’s congress-
ionally authorized authority—the statute explicitly prohibits it.
The FDA can regulate drugs and devices to ensure they are safe and
effective for their intended use, as indicated through labeling
requirements. But physicians decide on treatments—including off-
label prescribing of FDA-approved drugs and devices for unapproved uses—because they are best able to assess their patients’ circum-
stances and the evolving state of scientific knowledge. Off-label
usage is common and the standard of care in many specialties,
including oncology and pediatrics.

The FDA and other agencies should provide accurate, up-to-date
information and ensure an adequate supply and variety of treatments. Washington bureaucrats’ micromanagement of Covid-19 treatments that
are safe and effective in varying circumstances has to stop.

Dr. Zinberg is senior fellow at the Competitive Enterprise Institute,
director of Paragon Health Institute’s Public Health and American
Well-being Initiative, and associate clinical professor of surgery
at the Icahn Mount Sinai School of Medicine. He was general counsel
and senior economist at the White House Council of Economic Advisers
from 2017 to 2019.

https://www.wsj.com/articles/covid-patients-suffer-omicron-eua-monoclonal-antibody-treatment-lilly-regeneron-sotrovimab-hhs-fda-11644249715

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