How we can lower COVID hospitalization, fatality rates
The scientific and medical communities widely agree that using repurposed drugs and therapies is the fastest and most efficient way to attack new diseases.
Yet in this pandemic, medical authorities and drug companies have spent little effort on testing, research or approval of repurposed drugs. Thousands upon thousands of people may have died as a result.
At the onset of the pandemic, l created the COVID Early Treatment Fund with a dedicated group of volunteers. Our team raised more than $5 million to fund research into repurposed drugs. We were inundated with requests from researchers with ideas about existing drugs that might work against COVID-19.
One such drug that showed impressive results is fluvoxamine, a generic antidepressant. It has proved to be extremely effective in small randomized trials and in clinical use.
But it has been a long and frustrating battle. No one is willing to take a chance on a drug or therapy without a large, costly randomized clinical trial. And very few people are willing to fund studies on drugs that no longer are under patent.
We petitioned the Food and Drug Administration in late January for an emergency use authorization for fluvoxamine. After seven weeks, we received a notice that the authorization must be submitted by one of the manufacturers of the drug. That’s unlikely to happen for a generic drug, as there there is no financial incentive to do so.
That leaves only three options to save lives: 1) wait three months for a large phase 3 randomized trial of fluvoxamine to finish enrollment, 2) persuade physicians to use the drug now off-label, or 3) persuade the National Institutes of Health to add fluvoxamine to its COVID-19 treatment guidelines.
A panel of key opinion leaders from the NIH, Centers for Disease Control and Prevention and leading academic institutions met Jan. 22 to review the data for fluvoxamine. Their conclusion: Fluvoxamine should be added to the NIH guidelines. Unfortunately, the NIH panel ignored the experts’ advice.
Because the deliberations of the NIH panel are confidential, we don’t know why.
We can speculate that they are being conservative and want to see more data. But are the traditional standards of drug approval the right answer in a pandemic? We already have years of knowledge about repurposed drugs. Why must we wait for large, expensive trials — trials that most drug companies have no financial interest in pursuing because the drug is off patent.
If we just did one thing differently, we could dramatically reduce the hospitalization and fatality rate from COVID-19. The NIH COVID-19 treatment panel should study the four most promising drugs and make an assessment based on the total body of evidence for each drug, weighting each piece of evidence based on the quality of that evidence: randomized trials, quasi randomized trials, retrospective observational studies, plausible mechanisms of actions, anecdotal reports, etc. That evidence review does not need to be flawless. It just needs to be the best we know how to do. Then make the best treatments available and track them carefully.
Big Pharma and U.S. government health authorities have done an amazing job in quickly developing vaccines. But we should not be complacent simply because we now have vaccines.
People continue to die from COVID-19, and there are affordable, effective drugs available today that can help prevent deaths. Better methods to test, approve and distribute those drugs will save lives. Steve Kirsch is a high-tech entrepreneur and philanthropist based in Silicon Valley. He has financed medical research at leading institutions for more than 20 years and has created www.treatearly.org to advance outpatient clinical trials for emerging COVID-19 treatments.