Under pressure from the Trump White House on the eve of the Republican National Convention, the Food and Drug Administration issued an emergency use authorization yesterday for a potential therapeutic against COVID-19. But mainstream news coverage of the announcement largely ignored objections from public health experts that critical data needed to justify this move from the FDA is missing.
During the August 23 press conference announcing the change, both President Donald Trump and FDA Commissioner Stephen Hahn “grossly mischaracterized" what the data actually shows regarding the effectiveness of the new treatment, known as convalescent plasma. The authorization comes a day after the president’s baseless tweet over the weekend targeting Hahn, claiming “the deep state, or whoever, over at the FDA” are delaying therapeutic developments until after the election. This is the second emergency use authorization during the COVID-19 pandemic that has led to experts calling the FDA’s independence into question. The regulatory body granted expanded access to the antimalarial drug hydroxychloroquine following an immense pressure campaign by Trump and Fox News. That emergency use authorization was revoked months later, and the drug's use in treating COVID-19 was relabeled with a safety warning.
Data reflecting the effectiveness of treating COVID-19 patients with blood plasma rich with virus-fighting antibodies from other patients who have recovered from the disease, also called convalescent plasma, is not available due to the lack of randomized, controlled clinical trials. The FDA’s announcement cites an expanded access trial that does not include a placebo group, a necessary component to determine the treatment’s effectiveness. Research published in June from the Mayo Clinic found the treatment to be safe when administered to 20,000 patients, but the study has not been peer-reviewed and also did not have a placebo group.
The treatment’s new emergency use authorization was delayed by objections from experts, including Dr. Anthony Fauci, and arguably falls short of the FDA’s guidance on emergency use authorizations because of the lack of data on its effectiveness, although the FDA claimed otherwise in its announcement.
Many mainstream media outlets excluded those concerns from headlines covering the development, and some did not mention objections raised by scientists until well into the article. FoxNews.com’s coverage ignored skepticism from scientists altogether. This is part of a pattern in media headlines, which often repeat misinformation, political spin, and lies that come directly from Trump, leaving out the truth or burying it in the body of the article. Additionally, many of the articles did not explain why randomized controlled clinical trials are considered the “best evidence" in determining a drug’s effectiveness. (These types of trials are not mandated by the FDA in issuing an emergency use authorization, but without them, a critical portion of the data used to control research for bias is entirely missing.)
The New York Times’ headlines, both in its breaking updates coverage as well as the full write-up, did not mention the scientific community’s objections to the new treatment’s authorization.