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 That emergency use authorization was revoked months later, and the drug's use in treating COVID-19 was relabeled with a safety warning.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in June from the Mayo Clinic found the treatment to be safe when administered to 20,000 patients, but the study has not been peer-reviewed and also did not have a placebo group.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 headline from The Associated Press did not mention the objections to the new authorization from medical experts. However, the article did prominently feature Trump’s unfounded claim that the FDA is trying to slow down treatment development to hurt him politically in the article’s second paragraph. It didn't mention the lack of evidence and controlled trials until the fourth and fifth paragraphs.
The Wall Street Journal’s headline on the FDA announcement excluded the experts’ concerns. The Journal also ran an article on a boost in the stock market based on the development, but did not mention the destabilizing effect created by increased volatility in the markets due to “retail investors” reacting to “headline news” of potential treatments.
FoxNews.com’s article left objections from experts out of the headline and did not mention the “inconclusive” evidence for the new treatment’s authorization until the seventh paragraph. It also failed to mention the community of scientists concerned about its authorization and the White House’s political pressures on the FDA, nor did it mention the lack of a placebo group or the limitations of making regulatory decisions based on an expanded access trial.
Axios ran a headline that did not mention objections from the scientific community or lack of conclusive data on the treatment’s effectiveness, though both issues were referenced later in the article.
CNN’s headline did not mention concerns the experts had raised about the treatment’s effectiveness. The article did not mention the lack of randomized control trials until the seventh paragraph. Additionally, the section titled “Experts say more data is needed” led not with objections from scientists but with Secretary of Health and Human Services Alex Azar’s comments justifying the emergency use authorization. (Azar is a Trump sycophant and former pharmaceutical lobbyist, not a doctor.) Fauci’s concerns about the treatment were not mentioned until the 18th paragraph.
NBC News ran a headline without mentioning the inconclusive and lacking evidence.
CBS News’ headline did not mention limited evidence for the FDA authorization or objections by the scientific community. Although the report’s video package mentioned that the “medical research is not clear” on the effectiveness of the treatment, the news came in the context of reporting on White House politics and Trump’s reelection campaign, not scientific research and drug development. In the body of the short article which accompanied the video, the only mention of concerns from scientists was a quote from former FDA Commissioner Scott Gottlieb at the very bottom of the article.
CNBC ran at least two headlines on the emergency use authorization. One of them didn’t mention concerns about the treatment from scientists and top health officials, although the lede of the article did, while the other article did mention those concerns in the headline. Like other financial outlets, CNBC also ran an article on Monday’s market movements in response to the news that wholly excluded the lack of evidence regarding the treatment’s effectiveness or the role of misleading headlines about “positive developments on coronavirus treatments and vaccines” responsible for creating “bullish sentiment.”