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Morning Briefing

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Monday, Oct 12 2020

Full Issue

Large Trial Results Needed For COVID Antibody Cocktail, Regeneron CEO Says

Regeneron CEO Dr. Leonard Schleifer characterized the treatment outcome for President Donald Trump as just one "case study" and said that more information is needed about his company's experimental therapeutic, which Trump and one of his sons inaccurately touted as a "cure" or "vaccine."

Regeneron chief executive Leonard Schleifer on Sunday said President Donald Trump's treatment with the company's experimental antibody cocktail is "a case of one," but stressed ongoing clinical trials still need to show its efficacy. "The president's case is a case of one, and that's what we call a case report, and it is evidence of what's happening, but it's kind of the weakest evidence that you can get," Schleifer said in an interview on CBS' "Face the Nation." (O'Brien, 10/11)

Dr. Leonard Schleifer, the founder and CEO of Regeneron Pharmaceuticals, which developed the antibody cocktail heralded by President Trump, estimated Sunday that a $450 million contract the company won from the federal government over the summer will secure roughly 300,000 doses of the treatment. "They bought from us several hundred thousand, maybe around 300,000 doses, which they are going to make it for free," Schleifer said in an interview with "Face the Nation." "We can't do this alone. We need the entire industry." (Quinn and Tillett, 10/11)

When President Trump promoted an experimental drug as a 鈥渃ure鈥 for Covid-19 in a video on Wednesday, it might have seemed that he was at it again: touting a questionable fix for a deadly pandemic, not unlike his earlier enthusiasm for the malaria drug hydroxychloroquine or even, at one point, disinfectant. But the treatment that Mr. Trump extolled, which was administered last week after doctors diagnosed Covid-19, is not a fringe product. It鈥檚 a promising drug in the final stages of testing developed by a respected biotech company, Regeneron. Infectious disease experts have been closely following the treatment, as well as a similar product from Eli Lilly, in the hopes that the therapies could be a real advance in the fight against Covid-19. (Thomas and Grady, 10/9)

In related news 鈥

President Trump's public praise for an experimental coronavirus antibody treatment is putting new pressure on the Food and Drug Administration (FDA) to quickly give emergency clearance to a drug he has touted as a "miracle." Doctors think the drugs show promise as a potential treatment of COVID-19, though Trump has created confusion by quickly elevating them to a cure. (Weixel, 10/10)

President Trump鈥檚 son Eric Trump on Sunday called his father鈥檚 treatment for COVID-19 a vaccine that he further claimed the president helped create from 鈥渄ay one.鈥 鈥淢y father literally started day one creating this vaccine. He worked to push this vaccine, and now my father just took it, and you see how well he got over it,鈥 Eric Trump told Jonathan Karl of ABC's "This Week." (Rahman, 10/11)

President Trump鈥檚 long rants and seemingly erratic behavior last week 鈥 which some doctors believe might have been fueled by his use of dexamethasone, a steroid, to treat Covid-19 鈥 renewed a long-simmering debate among national security experts about whether it is time to retire one of the early inventions of the Cold War: the unchecked authority of the president to launch nuclear weapons. Mr. Trump has publicly threatened the use of those weapons only once in his presidency, during his first collision with North Korea in 2017. But it was his decision not to invoke the 25th Amendment and turn control over to Vice President Mike Pence last week that has prompted concern inside and outside the government. (Sanger and Broad, 10/11)

In another era, what happened Wednesday might have been viewed simply as good news. Two companies, Regeneron Pharmaceuticals and Eli Lilly, have independently developed therapeutic drugs, called monoclonal antibodies, that in preliminary testing appear to reduce symptoms for coronavirus patients. They applied for emergency use authorization from the Food and Drug Administration. The positive development immediately became entangled in election-year politics, with President Trump repeatedly making false and exaggerated claims about the new therapeutics. He called them a cure, which they鈥檙e not. He said he was about to approve them 鈥 a premature promise given that the FDA鈥檚 career scientists are charged with reviewing the applications. (Achenbach and McGinley, 10/11)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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