A leading financial and business daily, The Financial Times (FT) recently covered the mounting and controversial ivermectin discussion, sharing that the economical and widely-available generic drug evidences significant effects in reducing mortality associated with COVID-19 patients. The compelling work of Dr. Andrew Hill, with the University of Liverpool, apparently gained the attention of the business savvy FT. Dr. Hill’s comprehensive ivermectin and COVID-19 meta-analysis show that the drug can reduce inflammation and also accelerate the elimination of the SARS-CoV-2 virus. Pointing out that six of the studies in the meta-analysis involved a reduction of risk of death by 75% in a subset of moderate to severe COVID-19 patients, the FT author, Donato Paolo Mancini, reminds the reader that the only approved antiviral—Gilead’s Remdesivir—shows some benefit (e.g., reduced hospitalization by 4 days) but no clear association with a reduction in mortality. Moreover, the recent SOLIDARITY study findings led the World Health Organization (WHO) to the position that there are no real benefits associated with Remdesivir. Although all involved in the ivermectin debate call for more research, some researchers such as Dr. Hill and other physicians, such as Dr. Pierre Kory and Dr. Paul E. Marik, who co-lead the Front Line COVID-19 Critical Care Alliance (FLCCC), believe the time to review an emergency use authorization is now. As TrialSite has chronicled, the FLCCC has also produced an ivermectin meta-analysis, recently presented to not only a Senate hearing but also the National Institutes of Health (NIH) Treatment Guidelines Panel. The dedicated physicians’ impact was palpable on that powerful body. Just days later, the NIH Panel changed their recommendation from a “not recommended except for research” to “not for or against.” This leaves the door open for physicians and their patients to consider off-label use. The FLCCC issued a response that this progress wasn’t enough.
400,000+ Deaths in America
With the grim milestone of 400,000 deaths, the new POTUS undoubtedly has a target-rich environment to assign blame. Unfortunately for all Americans, the world’s largest economy and traditional superpower became the pandemic nexus, due in part to the politicization of the pandemic by both political parties. Although Operation Warp Speed produced brilliant vaccination results out of the many billions spent in just months, barely a penny was allocated to a number of promising existing drugs that could have potentially limited the deaths due to COVID-19. The New POTUS rightfully now speaks the truth about the future—that the pandemic situation will get worse before it gets better, but that if we all follow the prescribed practices of social distancing, embrace PPE, and get vaccinated, America and the rest of the world will pull out of this crisis. But for each and every life already lost, could there have been an available, economical treatment that might have reduced the horrific death count? Dr. Andrew Hill, the FLCCC and a growing number of researchers believe the answer is yes. Will the new POTUS embrace the same policies of his predecessor, essentially continuing to direct large amounts of R&D capital into novel therapies, or will there be a greater embrace of generic hopefuls such as ivermectin? Many lives are still in the balance in 2021.
A Cheap Drug with Evidence of Efficacy
The Financial Times is all about business. Founded in 1888, focusing on financial journalism and economic analysis and international trade, the globally-minded readership includes the highest circles in the Anglosphere. Mr. Mancini gets right down to the numbers, sharing Dr. Hill’s vantage that the generic drug ivermectin costs about 12 cents to make and fetches $3 in India and $960 in the US. Used all over the world for parasites such as lice and more serious ones such as those causing river blindness, FT declares, “The drug could make it harder for people to be infected and it could be harder for those with the disease to infect anyone else.” Billions have taken this drug over the past decades, and as the journalist, Mary Beth Pfeiffer declared writing for TrialSite, “Not using ivermectin one year in, is unethical and immoral.” Of course, the counter argument is that efficacy hasn’t been proven. But this is the same situation for convalescent plasma for which FDA approved for emergency use, despite the NIH’s reluctance. Again, the WTO recommends against the other anti-viral Remdesivir—in the US, the results of the Solidarity study were simply ignored, at least publicly.
There’s an old saying: A manager never got fired for selecting IBM. Although Dr. Hill, the FLCCC’s leadership, such as Dr. Pierre Kory and Dr. Paul Marik, and growing numbers of others believe that ivermectin needs to be considered now as a “treatment-prevention” strategy, in the US and Europe, the various government agencies that control research spending have other more pressing priorities apparently. The NIH agrees with Dr. Hill and the FLCCC—they too want various therapies that can help fight COVID-19, along with the vaccination strategy. And TrialSite has been one of the few consistent media platforms to report on the stakes involved here: for just a few monoclonal antibody developers, the NIH has spent a few billion dollars. In October, the NIH, via ACTIV and Operation Warp Speed, allocated $486 million to AstraZeneca to develop one novel monoclonal antibody that was identified initially at Vanderbilt. TrialSite supports such R&D, both for the branded entities as well as the generic approach such as ivermectin. It’s not an either-or false dilemma.
Not One Dime Allocated
Unfortunately, it appears that based on their actions, the NIH has looked at the ivermectin debate as a distraction more than anything else. In the aggregate, well over $13 billion has been spent on just a handful of companies. When counting the early-stage discovery and preclinical support as well, the total public support in America could be over $20 billion at this point. Although a number of research institutes have identified promising existing generic or branded drugs for repurposing, the emphasis has been on novel, generally expensive drugs. Have public agencies such as the NIH sought to help subsidize the pharmaceutical industry at the expense of overall public health? Unfortunately, and painfully because not one dime has been allocated to even consider a promising generic substance like ivermectin, the answer is yes.