What About Fluvoxamine?

Continuing in the vein of a discussion going on in comments, in the Wall Street Journal Allysia Finlay reports on a relatively inexpensive drug that’s been approved by the FDA for another purpose for quite a while that has shown some promise in treating COVID-19:

Yet a promising alternative isn’t getting its due: fluvoxamine, a pill the FDA approved in 1994 to treat obsessive-compulsive disorders. Doctors often prescribe it off-label for anxiety, depression and panic attacks. Studies show that fluvoxamine is highly effective at preventing hospitalization in Covid-infected patients, and it’s unlikely to be blunted by Omicron.

Doctors hypothesize that fluvoxamine can trigger a cascade of reactions in cells that modulate inflammation and interfere with virus functions. It could thus prevent an overreactive immune response to pathogens—what’s known as a cytokine storm—that can lead to organ failure and death. It also increases nighttime levels of melatonin—the hormone that makes you sleepy—which evidence suggests can also mitigate inflammation.

[…]

A small randomized control trial last year by psychiatrists at the Washington University School of Medicine in St. Louis was a spectacular success: None of the 80 participants who started fluvoxamine within seven days of developing symptoms deteriorated. In the placebo group, six of the 72 patients got worse, and four were hospitalized. The results were published in November 2020 in the Journal of the American Medical Association and inspired a real-world experiment.

Soon after the study was published, there was a Covid outbreak among employees at the Golden Gate Fields horse racing track in Berkeley, Calif. The physician at the track offered fluvoxamine to workers. After 14 days, none of the 65 patients who took it were hospitalized or still had symptoms. Of the 48 who didn’t take the drug, six, or 12.5%, were hospitalized and one died. Twenty-nine had lingering symptoms, which might have resulted from inflammatory damage to their organs. Those who took the placebo were more likely to be asymptomatic when they tested positive, so they would have been expected to fare better.

The studies drew the attention of Francis Collins, director of the National Institutes of Health. “A big need right now is for a drug that you could take by mouth, that you could be offered as soon as you had a positive test, and that would reduce the likelihood that the virus is going to make you really sick,” he said in an interview with “60 Minutes” in March. “Fluvoxamine could certainly be something you want to put in the tool chest,” Dr. Collins added. “It looks as if it has the promise to reduce the likelihood of severe illness.”

Researchers at McMaster University in Hamilton, Ontario, last winter launched a large clinical trial in Brazil. The results from their trial, published in the Lancet in October, were stunning: Fluvoxamine reduced the odds of hospitalization or emergency care by 66% and death by 90% among unvaccinated high-risk patients who mostly followed the treatment regimen—comparable to monoclonal antibodies. There was no difference in adverse effects between the fluvoxamine and placebo groups.

I have a certain amount of sympathy with the NIH and FDA on this one. I do wonder, however, how you reconcile patience in using a drug that’s been approved for quite and while and, consequently, reasonably well-known with the hurried emergency use authorizations being given to various vaccines and much more expensive pharmaceuticals used for treating the disease. Could its patent having elapsed a year and a half ago have anything to do with it?