The Food and Drug Administration is under attack for being too cozy with drugmakers, but there’s nothing wrong with regulators cooperating with private industry. That’s how we got Covid vaccines and therapies in record time. What’s rotten is that applications for new uses of generic drugs are reviewed under different standards than those for novel treatments. That’s what the FDA did this month when it rejected a Covid emergency-use authorization (EUA) application by doctors for the antidepressant fluvoxamine.
The media has derided some doctors as quacks for advocating off-label drugs like hydroxychloroquine and ivermectin. Early in the pandemic studies suggested the two anti-parasite drugs could be beneficial.
David Boulware,
an infectious disease specialist at the University of Minnesota, helped lead four of those trials. Yet he now strangely finds himself clashing with the FDA over its rejection of fluvoxamine.
In December, Dr. Boulware and several colleagues submitted an EUA application for fluvoxamine to treat non-hospitalized adult Covid patients. Three trials have shown the drug, typically prescribed for obsessive-compulsive and mood disorders, could prevent patients from becoming sicker, potentially because of its anti-inflammatory properties. One large randomized controlled trial in Brazil found that fluvoxamine reduced the risk of hospitalization or emergency care by 32%. Those who stuck to the treatment regimen were 66% less likely to be hospitalized and 91% less likely to die. The Lancet first published the findings in October.
A smaller trial in fall 2020 found that none of the 80 patients given fluvoxamine got worse compared with six of the 72 who received a placebo, four of whom were hospitalized. And in a real-world experiment at the Golden Gate Fields horse-racing track in Berkeley, Calif., none of the 65 workers who took the drug were hospitalized or had symptoms 14 days later….