Five months ago, I wrote about an old drug that showed great promise as treatment for Covid-19 (Fluvoxamine – Maybe the Perfect Covid Drug?) Today, it looks like fluvoxamine is just another drug embattled by the politics of the Biden Administration.
It seems that the Food and Drug Administration (FDA) does things differently when evaluating old drugs than they do for new ones. Allysia Finley, writing in The Wall Street Journal, says that applications for new uses of generic drugs are reviewed under different standards that those for novel treatments. For that reason, the FDA rejected a Covid emergency use authorization (EUA) application by doctors for use of the antidepressant fluvoxamine.
This has happened before. Hydroxychloroquine and ivermectin are two anti-parasitic drugs that appeared to be beneficial in the treatment of Covid early in the pandemic. David Boulware, an infectious disease specialist at the University of Minnesota, helped lead four of the trials of these drugs.
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 (the best type of research) in Brazil found that fluvoxamine reduced the risk of hospitalization or emergency care by 32 percent. Those who stuck to the treatment regimen were 66% less likely to be hospitalized and 91% less likely to die. These findings were first published in the British medical journal Lancet in October.
There’s more good news. 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 – and four of those were hospitalized. Moreover, it was found that at the Golden Gate Fields horse-racing track in Berkeley, California, none of the 65 workers who took the drug were hospitalized or had symptoms 14 days later. However, six of the 48 who didn’t were hospitalized, and more than half had lingering symptoms.
In my earlier post, I described the perfect Covid treatment would have the following characteristics:
- Effective in reducing hospitalizations and death
- Oral treatment available at home
- Proven safety record over many years
- Readily available
- Low cost
Fluvoxamine checks all of these boxes.
The FDA has issued many EUAs for new Covid treatments based on less evidence. The Merck-Ridgeback Biotherapeutics’ antiviral molnupiravir was authorized after a single trial found it reduced hospitalization among high-risk patients by 31% and death by 89%. The FDA authorized Eli Lilly’s monoclonal antibody bebtelovimabafter a small study found it reduced viral load in a greater share of patients on the seventh day of treatment. Yet the drug wasn’t found to reduce hospitalizations or death compared to placebo.
What accounts for this disparity of approvals?
Dr. Boulware assailed the agency’s “inconsistent logic” and its use of “different definitions for ‘hospitalization’ for big pharma vs. low-cost generic drugs.” He also criticized the FDA’s lack of clear guidance and expectations when dealing with medical researchers, which contrasts with its constructive working relationship with drugmakers.
Ms. Finley says some conservatives accuse regulators of trying to protect drugmaker profits by limiting access to repurposed generics, but there’s no evidence of that. The FDA in recent years has approved record numbers of generics, mostly while under the leadership of Dr. Scott Gottlieb, FDA commissioner during the Trump Administration. But there is new leadership in the White House and in the FDA. It’s hard not to believe there might be some influence of Big Pharma in the approval process of inexpensive, repurposed generic drugs.
Ms. Finley does say this: “But by applying inconsistent regulatory standards and rejecting fluvoxamine despite its demonstrated benefits, the FDA may engender more political cynicism that undermines support for pharmaceutical innovations such as Covid vaccines.”