TrialSite recently made the world aware that the South African Health Products Regulatory Authority (SAHPRA) actually criminalized the importation of ivermectin due to the growing interest in the economical and widely available drug in connection with COVID-19. TrialSite considered such a move strange, even bizarre; after all, the drug has a very well known safety profile given the drug’s extensive use in Africa to fight parasitic infection for example. The drug is already distributed in nearly 20 African countries. On Dec. 21 the government’s health authority issued the following guideline: “South African National Department of Health Evidence summary component.” First, TrialSite commends South Africa’s National Department of Health for citing the Frontline COVID-19 Critical Care Alliance (FLCCC) and Dr. Andrew Hill’s meta-analyses reports. They didn’t have to do this. This is more than most national health agencies have done via guidelines, and is a testimony to the South African Therapeutic Guidelines Sub-Committee for COVID-19 awareness of ongoing, rapidly unfolding research. They shared more than most governments have and for that TrialSite sends kudos to that organization. On the other hand, the team was very selective with what they shared in their analysis of evidence. The Department of Health opted to only review four studies despite the fact that the FLCCC has at least 11 randomized controlled trials associated with their meta-analysis and Dr. Andrew Hill has the world’s most extensive summary of Ivermectin-based randomized controlled trials with at least 16 studies. As a result, the South Africa National Department of Health ignored or for whatever reason precluded a dozen other Ivermectin-based clinical trials. This, of course, established the basis for their decision; that the existing evidence is still weak for Ivermectin efficacy targeting COVID-19. But the glass is half full.
Regardless, TrialSite’s point of view is that the South African Department of National Health took a step in the right direction by not only choosing to update their guidelines but also for citing the ongoing important work of groups and individuals such as the FLCCC and Dr. Andrew Hill.
Clearly there is a worldwide resistance among national health authorities to fully embrace the accumulating evidence for the powerful, and mounting evidence for Ivermectin as a treatment to be considered alongside monoclonal antibodies and of course the needed vaccines. Authorities are fixated on vaccine distribution and administration but this need not equate to an either-or false dilemma situation. In America, the crisis deepens as there are nearly 4,000 deaths per day; and with delays in vaccine roll out, so any treatments that show evidence for efficacy should be embraced. Moreover, not everyone will be able to take a vaccine. That is one reason why the U.S. government recently awarded AstraZeneca $486 million for a major monoclonal antibody Phase 3 clinical trial. This highly experimental drug draws major funding, and TrialSite supports AstraZeneca’s efforts, yet mounting evidence for low cost, and efficacious ivermectin drawn no money—only crickets.
Although it’s not clear why the National Department of Health cites both FLCCC and Dr. Hill’s meta-analysis yet opt to only include a small subset of trials for their analysis raises a number of questions. But in conclusion at least the subcommittee in South Africa took a turn in the right direction.
Call to Action: Follow the link to review the document titled “South African National Department of Health Evidence Summary Component: COVID-19.” For the FLCCC meta-analysis, follow the link. For an update on the meta-analysis from Dr. Hill, follow the link.