{"id":1882,"date":"2021-08-12T08:18:19","date_gmt":"2021-08-12T08:18:19","guid":{"rendered":"http:\/\/wp.cov19longhaulfoundation.org\/?p=1882"},"modified":"2021-08-12T08:18:19","modified_gmt":"2021-08-12T08:18:19","slug":"the-very-very-bad-look-of-remdesivir-the-first-fda-approved-covid-19-drug","status":"publish","type":"post","link":"https:\/\/cov19longhaulfoundation.org\/?p=1882","title":{"rendered":"The \u2018very, very bad look\u2019 of remdesivir, the first FDA-approved COVID-19 drug"},"content":{"rendered":"\n<p>Authors: <strong>By\u00a0<\/strong><a href=\"https:\/\/www.sciencemag.org\/author\/jon-cohen\">Jon Cohen<\/a><strong>,\u00a0<\/strong><a href=\"https:\/\/www.sciencemag.org\/author\/kai-kupferschmidt\">Kai Kupferschmidt<\/a>Oct. 28, 2020 , 7:05 PM<\/p>\n\n\n\n<p style=\"font-size:24px\">October was a good month for Gilead Sciences, the giant manufacturer of antivirals headquartered in Foster City, California. On 8 October, the company inked an agreement to supply the European Union with its drug remdesivir as a treatment for COVID-19\u2014a deal potentially worth more than $1 billion. Two weeks later, on 22 October, the U.S. Food and Drug Administration (FDA) approved remdesivir for use against the pandemic coronavirus SARS-CoV-2 in the United States\u2014the first drug to receive that status. The EU and U.S. decisions pave the way for Gilead\u2019s drug into two major markets, both with soaring COVID-19 cases.<\/p>\n\n\n\n<p style=\"font-size:24px\">But both decisions baffled scientists who have closely watched the clinical trials of remdesivir unfold over the past 6 months\u2014and who have many questions about remdesivir\u2019s worth. At best, one large, well-designed study found&nbsp;remdesivir modestly reduced the time to recover from COVID-19 in hospitalized patients with severe illness. A few smaller studies found no impact of treatment on the disease whatsoever. Then, on 15 October\u2014in this month\u2019s decidedly unfavorable news for Gilead\u2014the fourth and largest controlled study delivered what some believed was a coup de gr\u00e2ce: The World Health Organization\u2019s (WHO\u2019s) Solidarity trial showed that remdesivir does not reduce mortality or the time COVID-19 patients take to recover.<\/p>\n\n\n\n<p style=\"font-size:24px\">Science\u00a0has learned that both FDA\u2019s decision and the EU deal came about under unusual circumstances that gave the company important advantages. FDA never consulted a group of outside experts that it has at the ready to weigh in on complicated antiviral drug issues. That group, the Antimicrobial Drugs Advisory Committee (AMDAC), mixes infectious disease clinicians with biostatisticians, pharmacists, and a consumer representative to review all available data on experimental treatments and make recommendations to FDA about drug approvals\u2014yet it has not convened once during the pandemic.<\/p>\n\n\n\n<p class=\"has-large-font-size\">For More Information: <a href=\"https:\/\/www.sciencemag.org\/news\/2020\/10\/very-very-bad-look-remdesivir-first-fda-approved-covid-19-drug\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.sciencemag.org\/news\/2020\/10\/very-very-bad-look-remdesivir-first-fda-approved-covid-19-drug<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Authors: By\u00a0Jon Cohen,\u00a0Kai KupferschmidtOct. 28, 2020 , 7:05 PM October was a good month for Gilead Sciences, the giant manufacturer of antivirals headquartered in Foster City, California. On 8 October, [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":1883,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[928],"tags":[],"class_list":["post-1882","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-remdisivir"],"_links":{"self":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/1882","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1882"}],"version-history":[{"count":0,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/1882\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/media\/1883"}],"wp:attachment":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1882"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1882"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1882"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}