Covid Patients Suffer as the Biden Administration Tries to Practice Medicine

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

The Food and Drug Administration granted emergency-use authorizations for three 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 laboratory-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 government for distribution to hospitals nationwide. The government eventually allowed facilities to order doses directly. But on Sept. 13 the Health and Human Services Department 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 government 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 government 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 department 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.

Read the full article at The Wall Street Journal.