Why is this Funder Going it Alone to Find a COVID-19 Medicine?

Back in June, when the pandemic was getting scarier by the day, we wrote about a new pandemic-focused research foundation, the COVID-19 Early Treatment Fund. It was created by internet pioneer and tech guy Steve Kirsch, who wanted to speed up efforts to identify and test antivirals and other drugs that could treat or cure COVID-19 at the earliest stages of the disease, before patients got so sick they needed hospitalization or died.

At the time, vaccines were still a big question mark, and Kirsch figured (pretty reasonably, it seems) that early treatments could turn COVID-19 into a trivial medical condition, rather than the global health and economic disaster it has become. Even now, with vaccines going into shoulders worldwide, it still makes great sense to have an early treatment for COVID-19.

Surprisingly, the idea of repurposing approved drugs to treat early COVID-19 cases was a largely ignored area in the research world, with a few pharmaceutical exceptions, such as hydroxychloroquine. That drug, eventually determined ineffective against COVID-19, was touted by a few researchers on the basis of dubious data, not to mention a certain former president with an even more dubious grasp of biology. (Bleach injection, anyone? No? No takers?)

The need for early treatments for COVID-19 didn’t disappear just because effective vaccines arrived on the scene. For one thing, it will take years to vaccinate everyone, so people will still get sick. And wherever the virus persists, new variants can emerge that can sicken the vaccinated as well as the unvaccinated. And of course, some people have been refusing to take the vaccine.

“A big need is a pill that can be offered as soon as someone gets a positive (COVID-19) test to reduce their chance of ending up in the hospital,” Kirsch said. Since it takes months or years to develop a new drug, and then to get FDA approval, identifying already-approved drugs can mean the difference between life and death for COVID-19 patients.

Kirsch seeded the COVID-19 Early Treatment Fund with $1 million of his own money, expecting to raise additional funds to advance the research. Kirsch put out call after call after email for additional funders, and as we wrote back in the summer, the response was… crickets.

However, in another interesting development, a couple of Sundays ago, people everywhere saw Kirsch and researchers on “60 Minutes,” discussing just the sort of potential treatment he’s been talking about. (And by “people everywhere,” we mean “people who still watch ‘60 Minutes.’”) The show had aired a segment about researchers and doctors who have tested a familiar antidepressant pill called fluvoxamine—a close relative of fluoxetine, aka Prozac—an SSRI that has been used for decades to treat OCD and other conditions. Fluvoxamine is also known under the brand name Luvox.

Two studies in COVID-19 patients provided encouraging results: Not one person who took fluvoxamine got sick enough to be hospitalized, much less die. Meanwhile, several of the patients who did not take the drug developed serious disease, and one died. The hopeful numbers, Kirsch said, were unlikely to be the results of chance. It’s possible fluvoxamine prevents the runaway immune response, called sepsis, that is a hallmark of serious COVID-19 illness, among other potentially deadly immune-response conditions.

The researcher who did the first small fluvoxamine study could not obtain funding for a larger study until Kirsch’s CETF stepped in with support. By mid-March, the new, larger study had enrolled about 360 test participants, with researchers aiming for 1,100 participants.

Not much better than philanthropy’s cold shoulder, Kirsch said, is the FDA’s. “Fourteen-hundred people a day are dying, and it’s taking us seven weeks just to have a conversation about fluvoxamine with the FDA, and it’s the top drug on the list,” he said.

Kirsch is still having a tough time raising money for the CETF—or even getting meetings with potential co-funders to discuss the topics. One bright spot: after the “60 Minutes” segment, a wealthy individual donor pledged $500,000 to the CETF.

Maybe fluvoxamine will prove to be an important new tool in the treatment of COVID-19, maybe not. And there are medical research funders out there broadly supporting development of treatments. Wellcome, for example, just pledged $100 million in new funding to accelerate COVID-19 research and development to ensure science keeps pace with the virus, including treatments across all stages of the disease.

But the dearth of response to Kirsch’s call for funding of early-stage treatments is kind of mystifying. It’s also a reminder of the pivotal role science philanthropists can play in backing something that may only have an outside chance of gaining traction—but which deserves a chance nonetheless.

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