“The argument that the earlier you use it the better is great until you realize what the implications of that are: You won’t save many lives, and you’ll have to treat a lot of patients,” Landry told Science. “It’s very inconvenient, and it’ll cost you a fortune.”
Perhaps it was inevitable that Gilead would receive special treatment. In May, when remdesivir was given its EUA, the company’s chief executive officer, Daniel O’Day, was welcomed into the Oval Office for a photo op with President Donald Trump and FDA Commissioner Stephen Hahn. Trump, who was treated with remdesivir after contracting Covid-19 himself, has described it as one of a handful of drugs he received that were like “miracles coming down from God.”
Hospitals have been less enthusiastic and have been sharply cutting back their use of remdesivir due to its expense and its value for only the most seriously ill patients—which makes the FDA’s enthusiasm for the drug and its manufacturer all the more curious. The FDA approved remdesivir based on three trials, the most weighty of which was conducted by the National Institutes of Health. Both the NIH and the FDA are housed under the Department of Health and Human Services.
Perhaps it was just fine that the FDA relied on what was essentially an in-house trial to approve remdesivir and that Hahn has been unusually amenable to Trump’s demands for approving sketchy Covid-19 treatments. And perhaps it’s fine that Alex Azar, a former pharmaceutical executive and Big Pharma lobbyist who is a Trump loyalist, runs HHS and supervises Hahn.
In case any of this isn’t fine, we should bear it in mind as HHS and the FDA continue to play pivotal roles overseeing the approval, rollout and regulation of more crucial drugs: the Covid-19 vaccines that Pfizer Inc. and Moderna Inc. have put on the table.
Timothy L. O'Brien is a senior columnist for Bloomberg Opinion.