{"id":9777,"date":"2020-08-24T20:19:46","date_gmt":"2020-08-25T00:19:46","guid":{"rendered":"https:\/\/blogs.nejm.org\/hiv-id-observations\/?p=9777"},"modified":"2020-09-04T10:10:31","modified_gmt":"2020-09-04T14:10:31","slug":"fdas-emergency-use-authorization-for-convalescent-plasma-for-covid-19-seems-to-be-fooling-no-one","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/fdas-emergency-use-authorization-for-convalescent-plasma-for-covid-19-seems-to-be-fooling-no-one\/2020\/08\/24\/","title":{"rendered":"FDA’s Emergency Use Authorization for Convalescent Plasma for COVID-19 Seems To Be Fooling No One"},"content":{"rendered":"

\"\"<\/a>Starting late Saturday night, and proceeding the next day — like a relentless series of coming attractions for a blockbuster summer movie or the finale of a reality TV series — we repeatedly heard word that the President planned to make an announcement Sunday evening about a “major therapeutic breakthrough” in treatment of COVID-19<\/a>.<\/p>\n

6 p.m. Eastern. Live. Get ready. Here it comes.<\/p>\n

And, satisfying the ratings-hungry entertainer he once was (and some would say still is, though “entertainer” must be used cautiously in this context), we turned up to hear him cite this \u201cpowerful therapy\u201d that \u201chad an incredible rate of success.\u201d<\/p>\n

No, it’s not hydroxychloroquine.<\/p>\n

This time it’s convalescent plasma<\/em>. That liquid gold harvested from recovered COVID-19 patients, swimming in antibodies directed against SARS-CoV-2, and also containing a veritable secret sauce of illness-reversing substances that have fascinated doctors and scientists for decades.<\/p>\n

Never mind that harvested convalescent plasma isn’t used commonly to treat any<\/em> infection currently<\/a>.<\/p>\n

Or that the randomized trials of this treatment have so far been disappointing.<\/p>\n

Or that the observational data<\/a> the FDA used to justify their action come from an unpublished study not yet subject to peer review.<\/p>\n

(Here’s the next best thing<\/a>, for those inclined to take a deep dive into data analysis.)<\/p>\n

Or that the very experts employed by the government to review plasma’s safety and efficacy have as recently as last week raised important concerns about the lack of convincing evidence for this treatment<\/a>.<\/p>\n

Or that this action by the FDA will almost certainly jeopardize any existing randomized trials of convalescent plasma in the United States.<\/p>\n

Or that the person from the FDA who reviewed the plasma data had his name redacted from the memo<\/a>.<\/p>\n

Or that the emergency use authorization may make patient care more<\/em> difficult, since this will necessarily be a limited resource — especially if antibody titer turns out to be a critical determinant of whether this works, and since antibodies appear to fade in many people soon after they have COVID-19.<\/p>\n

Nope — no matter. On the evening of a major political event — timing that cannot be coincidental — the president got his ratings.<\/p>\n

He had to do a little intimidation, but we’re getting used to that.<\/p>\n

\n

The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives! @SteveFDA<\/a><\/p>\n

— Donald J. Trump (@realDonaldTrump) August 22, 2020<\/a><\/p><\/blockquote>\n