• Covid Patients Suffer as the Biden Administration Tries to Practice Med

    From (David P.)@21:1/5 to All on Sat Feb 12 10:58:09 2022
    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

    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.


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