Steve Kirsch, a former tech entrepreneur who earned a fortune worth up to $300 million, has been showcased on TrialSite a few times for his activity supporting the clinical development of repurposed drugs for COVID-19 treatments. The founder of the COVID-19 Early Treatment Fund, he supported research at Washington University School of Medicine in St. Louis revealing that the Selective Serotonin Reuptake Inhibitor/anti-depression drug demonstrates strong evidence that it is in fact an effective treatment against COVID-19. Combinations of real world data and information from Principal Investigator Dr. Eric Lenze who presented on the TrialSite podcast show, culminating in two published studies, has led Kirsch to now put serious chips on the table. Kirsch is so confident in the drug’s efficacy targeting COVID-19 that if given within the first 7 days after first symptoms appear, it can reduce hospitalization rate associated with COVID-19 respiratory distress by 20% or more. While Mr. Kirsch continuously hears the term from the medical community “We need more data,” he reminds all that traditionally his fluvoxamine study has met traditional Phase 2 trial and Phase 3 trial evidence threshold—statistical significance. Noting “That’s a p-value of .0025 or lower,” he reminded all that Francis Collins, Director of the National Institutes of Health (NIH), is on the record that 20% or greater is significant, and that “both published randomized studies for fluvoxamine” has effect size at 100%.
All You Need You Already Have
With the evidence already seemingly on the table and available for all to read and understand, he places real money chips. After all, the fluvoxamine data according to Kirsch exceeds not only statistical confidence but also effect size and, consequently, the program has satisfied industry standard evidentiary thresholds. Both studies are published now—peer reviewed—and for the physicians that have embraced this regimen, declared Kirsch, the results speak for themselves. Thus, Kirsch recently declared in his tweet, “I claim that nobody in the world can produce any evidence that we need more evidence.”
Kirsch further posited in his tweet that Dr. Syed Haider with Northwestern Medical Group included fluvoxamine in his regimen thanks to the fluvoxamine protocol; after treating one hundred patient,s the hospitalization rate involving COVID-19 has plummeted from 10% down to 0%. That’s impressive!
Kirsch’s point is pretty straight forward, if this was an expensive biopharmaceutical, for example, emergency use authorization would have probably already been on the table with the U.S. Food and Drug Administration (FDA). But because this is a low cost, repurposed drug, perhaps there are some subtle or not so subtle societal forces interrupting what should be embraced for demands for more evidence.
But what about the Patients?
However, with such evidence for efficacy with a safe profile, why would patients be deprived of an approach to make them better in this age of pandemic? Why would the medical establishment powers-that-be continue to demand more and more evidence when they themselves don’t demand the same accountability for high-priced, highly experimental novel therapies? Kirsch asks a very important question: “Is it really prudent to wait many months for more evidence from randomized controlled trials? Do you really think all these stories are we just got ‘lucky.’”
Therefore, Kirsch hereby proclaims that he will offer $25,000 for the first person to step forward with real evidence that proves that the existing combined evidence produced by the fluvoxamine researchers don’t meet the bar.
The rules include that the winner must first bring “actual proof” that is real tangible evidence that 1) there is a .25% probability or greater that the results could be reproduced by pure chance, and 2) that there is a 95% chance or greater that the effect size is fewer than 20%. But if nobody can prove the team wrong, it’s time to acknowledge they are correct!
Call to Action: Note that Dutch pharmaceutical executive Bart Reijs has committed to add another $5,000 to the pot! Who else wants to pitch in?