Why won't the FDA let doctors prescribe fluvoxamine for Covid?

The Food and Drug Administration is under attack for being too comfortable with drugmakers, but there’s nothing wrong with regulators coop...


The Food and Drug Administration is under attack for being too comfortable with drugmakers, but there’s nothing wrong with regulators cooperating with private industry. This is how we got Covid vaccines and therapies in record time. What’s rotten is that applications for new uses of generic drugs are reviewed to different standards than new treatments. That’s what the FDA did this month when it rejected a Covid Emergency Use Authorization (EUA) request by physicians for the antidepressant fluvoxamine.

The media has derided some doctors as charlatans for advocating off-label drugs like hydroxychloroquine and ivermectin. Early in the pandemic, studies suggested that both antiparasitic drugs could be beneficial. David Boulware, an infectious disease specialist at the University of Minnesota, helped lead four of these trials. Yet he now finds himself in a strange conflict with the FDA over his rejection of fluvoxamine.

In December, Dr. Boulware and several colleagues submitted an EUA request for fluvoxamine to treat non-hospitalized adult Covid patients. Three trials have shown that the drug, usually prescribed for obsessive-compulsive disorder and mood disorders, could prevent patients from getting sicker, potentially due to its anti-inflammatory properties. A large randomized controlled trial in Brazil found that fluvoxamine reduced the risk of hospitalization or emergency care by 32%. Those who followed the treatment regimen were 66% less likely to be hospitalized and 91% less likely to die. The Lancet first published the results in October.

A small test in the fall of 2020 found that none of the 80 patients who received fluvoxamine got worse compared to six of the 72 who received a placebo, four of whom were hospitalized. And in a real-life experiment at Golden Gate Fields horse racing track in Berkeley, Calif., none of the 65 workers who took the drug were hospitalized or showed symptoms 14 days later. However, six of 48 (12.5%) who were not hospitalized and more than half had persistent symptoms.

The FDA has issued numerous EUAs for new Covid treatments based on far less evidence. Consider Merck-Ridgeback Biotherapeutics’ antiviral molnupiravir, which the FDA cleared in December after a single trial found it reduced hospitalizations in high-risk patients by 31% and deaths by 89%.

In February, the FDA cleared

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the monoclonal antibody bebtelovimab after a small study found that it reduced viral load in a greater proportion of patients on the seventh day of treatment. It is unclear whether this translated into a significant clinical benefit, and the drug did not reduce hospitalizations or deaths compared to the placebo group.

The FDA justified its approval of bebtelovimab because it said there were few treatment alternatives. At the time there was no

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the antiviral Paxlovid, which has been found to reduce the risk of hospitalization or death by nearly 90%, and the antiviral molnupiravir from Merck. Paxlovid also interacts with dozens of drugs, including common cancer drugs, blood thinners, and blood pressure medications, so many high-risk patients can’t take it. The FDA wasn’t wrong that there is a need for more treatments.

Yet after sitting on fluvoxamine’s application for nearly five months — most other EUAs were approved within two years — the FDA advised Dr. Boulware this month that “the therapeutic benefit of fluvoxamine n was not convincing when focusing on clinically meaningful results”. How is preventing serious illness not a clinically meaningful outcome?

The FDA quibbled that “the timeline for trials spanned different periods” of the pandemic and that “the demographics of patient populations were not uniform.” Eh? These are strengths of the trials because they show that the benefits can be generalized across different patient populations, settings and variants. This turned out not to be the case for monoclonal antibodies or even vaccines, which became less effective against new variants.

The agency also said there are many alternative treatments available. Never mind that the Biden administration has warned that it may need to ration antiviral and monoclonal treatments unless Congress shells out billions to buy more. A 10-day course of fluvoxamine costs around $5 compared to $500 to $700 for Paxlovid and molnupiravir. Monoclonals cost around $2,000.

Doctors are also concerned that Paxlovid could breed resistance to antivirals, as some patients report relapses after completing treatment. The more an antiviral is used, the more likely a virus is to develop mutations that render the drug ineffective. That’s why the United States needs a broader arsenal of therapies, a point Dr. Boulware made in a rebuttal to the FDA.

Dr Boulware attacked the agency’s “inconsistent logic” and its use of “different definitions of ‘hospitalization’ for big pharma versus low-cost generic drugs”. He also criticized the FDA’s lack of clear guidance and expectations when it comes to medical researchers, which stands in contrast to its constructive working relationships with drugmakers.

Some conservatives accuse regulators of trying to protect drugmakers’ profits by limiting access to repurposed generics. There is no evidence for this. In recent years, the FDA has approved a record number of generics. But the FDA doesn’t like attracting political controversy. And there’s no doubt that other repurposed drugs like ivermectin have been controversial.

But by applying inconsistent regulatory standards and rejecting fluvoxamine despite its demonstrated benefits, the FDA may breed more political cynicism that undermines support for pharmaceutical innovations such as Covid vaccines.

Ms. Finley is a member of the Journal’s Editorial Board.

Following advice from the CDC, the Biden administration is appealing the decision to rescind the national mask mandate on public transportation. But it seems the appeal is not limited to the pandemic. Images: AFP/Getty Images Composition: Mark Kelly

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