Less than a month ago, the Food and Drug Administration said hospitals could use remdesivir, a drug manufactured by Gilead Sciences Inc., to treat patients with Covid-19. Remdesivir, sold under the brand name Veklury, was said to shorten recovery times and reduce the need for ventilators to facilitate breathing. Yesterday, the World Health Organization hit the brakes: It recommended that doctors avoid using the drug altogether.
"There is currently no evidence that remdesivir improves survival and other outcomes in these patients," the WHO noted, citing detailed studies it sponsored. "The evidence suggested no important effect on mortality, need for mechanical ventilation, time to clinical improvement, and other patient-important outcomes."
A group of experts gathered by the WHO concurred, reporting their findings in a well-regarded medical journal. Remdesivir offers "small and uncertain benefits" outweighed by the "possibility of important harms," they wrote. Gilead pushed back, saying it stands by remdesivir and citing other studies supporting its efficacy.
Speed is prized in the race to beat back Covid-19 — as it should be. The world is also fortunate to have innovative and dedicated public and private researchers able to produce coronavirus vaccine candidates in record time. But the WHO's thumbs-down on remdesivir is also a reminder that hasty drug development and approval is risky. It highlights why the FDA has to do more than merely rubber-stamp Covid-19 treatments in the face of heavy White House pressure to move quickly.
As my colleague Max Nisen recently observed, it's perplexing that the FDA gave formal approval to remdesivir as a Covid-19 treatment in October. The drug was already available to hospitals and patients under a federal emergency use authorization granted in May. Since then, data supporting its benefits had become murky, and an FDA sign-off was unlikely to significantly expand its use. As I noted in an earlier column, remdesivir is also expensive — perhaps not as costly as other blockbuster drugs the pharmaceutical industry sells, but still expensive.
Two writers for Science magazine, Jon Cohen and Kai Kupferschmidt, offered some answers to these mysteries in a deeply reported piece published late last month. They found that the FDA and the European Union both had approved the use of remdesivir despite some glaring procedural gaps. The FDA didn't consult the outside experts it keeps on tap to analyze approvals for complex antiviral drugs. The EU approved remdesivir's pricing just a week before lackluster results from a major WHO trial of the drug were published — and then seemed clueless about the new data. (Gilead was aware; it had donated drug to the trial and knew the results were poor.)
The Science writers pointed out that the FDA's inaction around remdesivir "stands in sharp contrast to its handling of potential Covid-19 vaccines." For remdesivir, the agency failed to convene an advisory to study the drug. Several prominent medical researchers voiced skepticism about remdesivir in the Science article, including Martin Landry of Oxford University, who said the drug was useless for treating the sickest patients. In any case, most people with Covid-19 recover without medical treatment.
"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.
Disclaimer: This article first appeared on bloomberg.com, and is published by special syndication arrangement.