Keith Speights writes for investment advisory website Motley Fool and brings the eclectic and varied background TrialSite appreciates. Mr. Speight highlighted remdesivir is one of the few drugs out there more widely known for its generic name other than its trade name. Of course, due to pandemic conditions its maker, Gilead, has received white glove care (e.g. changing endpoints in ACTIV-1 trial leading to the emergency use authorization (EUA) and a over $1 billion committed before the drug was even approved—which it was rust recently by the U.S. Food and Drug Administration (FDA). Well to be more precise Mr. Speights reminds they generated $873 million in the third quarter—its first such full quarter on the market. Undoubtedly a blockbuster for now but the investor/analyst Speights asks the question: will this be a blockbuster drug for a while or will this be a more brief affair? As competitive forces mount, let’s also remember the groundswell of clinicians reminding the public about what the medical industrial complex wants the public not to know. Investors make the final call.
What is Mr. Speights argument for short-shelf life?
First and foremost, he reminds all of the recently Solidary Trial results. Sponsored by the World Health Organization (WHO), Solidarity revealed that this largest of randomized controlled trials revealed that remdesivir offered no benefit as measured by reduction in mortality or even no reduction in recovery time—a terrible disappointment. Of course detractors suggest the results weren’t peer reviewed and hence nobody should rush to judgement just yet. Moreover, not surprisingly, the sponsor wasn’t crazy about the trial design which emphasized broad access but that naturally leads to heterogeneity in trial adoption, implementation controls and patient population reminds Speights. But still, no benefits. That’s not good.
Secondly Speights cautions potential Bulls as to the forthcoming competition, whether its low cost corticosteroids (RECOVERY trial reveals dexamethasone can reduce COVID-19 death rate in hospitalized patients needing ventilator or mechanical support device), to promising monoclonal antibodies. Although some problems have surfaced with both Regeneron (REGN-CoV2) and Lilly (LY-CoV555) significant data accumulates toward a promising outcome. Time will tell but both companies have submitted emergency use authorizations. TrialSite has written that both companies have experienced trial delay (at least one trial) due to a safety observation (patients in hospital or emergency room with high-flow oxygen or need of mechanical ventilation) or quality issue at a production facility.
Third is the real potential of the COVID-19 vaccine candidates. Speights reminds that at least a couple of the experimental vaccines may achieve EUA status before the end of 2020. TrialSite notes in the “East” (e.g. China, Russia) vaccine candidates have been registered and although partly a marketing strategy, they are being administered to multiple groups and hundreds of thousands and thus far there are no major safety signals—but that of course doesn’t mean that there are none given the government structure, etc.
Fourth and something Speights doesn’t dare touch (too controversial) would be the wave of physicians establishing pragmatic protocols that appear to be working. These in fact compete with remdesivir and of course will be suppressed for as long as possible. There is a “medical industrial complex” and it must accumulate ever growing revenues. That’s unfortunately the logic of the system turning great people into great business operatives; however, the society could pay a price.
Call to Action: What are your thoughts on remdesivir? Will it be a blockbuster for the long run? Check out Mr. Speights articles. They are more often than not informative and importantly candid.