The South African pollical party known as the National Freedom Party or “NFP” appears perturbed that a well-known, economical generic drug used throughout much of Africa to fight parasites has been banned from importation in that country with threat of criminal prosecution. As TrialSite recently reported about the decision by the South African health Products Regulatory Authority (SAHPRA), it seemed coincidental that after a recent presentation about the meta-analysis evaluating Ivermectin studies in association to COVID-19 that the national drug regulator’s response was to threaten anybody that imports the drug with jail. This appeared just a bit of a draconian approach. Why not verify the growing number of studies with a clinical trial? TrialSite did acknowledge South Africa for updating its national guidelines (including Ivermectin for research), which is more than many other nations have done as of late. Now, however, the NFP is threatening imminent legal action, making the case that the drug should be properly reviewed by medical authorities and rolled out to its citizenry as a therapy while they await vaccination. Their argument: it can be used for the 90% that haven’t been vaccinated yet to protect them from getting sick. Meanwhile, South Africa’s Health Minister Zweli Mkhize reports the country has signed up with COVAX, the global pool that helps developing nations obtain vaccine product. The financing is still getting worked out but reports from local media are that they seek to immunize 67% of the population by the end of 2021. So that’s quite a while to wait, suggests NFP MP Ahmed Munzoor Shaik Emam, who declared they are headed to the courts if the South African government continued to use draconian laws to keep it away from those that want a treatment. With the worst COVID-19 situation in the continent, the NFP’s point is a lot of death can be avoided in the duration awaiting a vaccine to reach everyone. Of course, the SAHPRA’s point is that there isn’t enough evidence as of yet.
SAHPRA has been on the record that “Ivermectin is not indicated nor approved by SAHPRA for use in humans. There is no confirmatory data on Ivermectin available as yet for its use in the management of COVID-19 infections.” And of course, TrialSite reported on their move, not only banning the importation but making it a potential criminal offense for anyone that tries—even if just doctors trying to save patient lives. It’s not hyperbolic to suggest that SAHPRA’s response was exaggerated—they clearly were perturbed by growing calls for use of the drug in that country. They must straggle a fine line as the drug isn’t accepted yet by any major health authorities or apex research agencies on the one hand, while on the other there appears to be a growing community-driven movement to verify the drug’s efficacy at least through public-subsidized testing. After all, major pharmaceutical companies are now getting subsidized in a big way in places such as the United States, for example. Operation Warp Speed has invested over $13 billion in public funds in just a handful of vaccine and monoclonal antibody makers.
More Testing Required but ACTIV Decides
Of course, there is no definitive proof yet that Ivermectin is in fact a treatment. There is a meta-analysis that demonstrates considerable evidence, and TrialSite has suggested for many months now that Western governments conduct tests to assess the potential for the lower cost, generic approach to treating COVID-19 in conjunction with vaccination and other novel approaches, such as laboratory designed monoclonal antibodies. One of the drug’s major manufacturers, Edenbridge Pharmaceuticals, could be supported and sponsored, for example. The West could lead this way, rapidly testing this drug to determine the true efficacy. Although a few tests are being done in the U.S. they are underfunded and need the help of ACTIV, led by NIAID, which has consolidated trial site networks to streamline and rationalize research during the pandemic. Called the COVID-19 Protection Network, the nation’s major infectious disease investigational networks were consolidated and managed in a bid to rationalize research during the pandemic. As TrialSite has reported, ACTIV decided which drugs were included for public subsidy via various NIH grants, Operation Warp Speed and the like.
Britain’s Dr. Andrew Hill, associated with University of Liverpool, has developed the most sophisticated meta-analysis along with the Front Line COVID-19 Critical Care Alliance (FLCCC) in the United States. TrialSite has chronicled the advancement of the knowledge of this drug since April when some enterprising scientists at University of Monash identified in a cell culture that the cheap, available drug absolutely annihilated SARS-CoV-2 in 48 hours. Importantly, this was at high doses and the research establishment, rightfully in the United States, expects considerable preclinical safety and dosing studies on animals before any compound goes into in-human studies. Of course, COVID-19 represented no ordinary times. Moreover, ivermectin wasn’t a novel substance but rather is a well-known drug used to treat parasites. Literally billions of people have used the drug around the world for decades now. Hence, it was the developing world that first started embracing Ivermectin and TrialSite covered the growing controversy of the drug in the West.
More testing in the traditional way wasn’t in the playbook during a pandemic. What happened as TrialSite articulated in a documentary made about the situation in Peru, was that community doctors started experimenting with the drug off label; that occurred in many nations around the world as the drug was again already approved to fight parasites. In parallel, numerous randomized studies were launched (probably 100 of observational studies and case series included) and the results thus far have been quite promising as reported by Dr. Hill and the FLCCC. Dr. Hill in the UK is awaiting three more studies from South America, which will bring his total to 3,000 patients. This was the number he explained in an interview that was used to justify initially the remdesivir approval.
Power, Politics & Drugs
A drug is now the center of a political conflict as this South African party seeks to challenge what many rational a person would consider a draconian law established by the South African health regulator. Hiring some well known lawyers named Subrayan Naidoo Attorneys, writes Siviwe Feketha from Independent Online. They point out that not only is the COVAX vaccine expensive but it has yet to be approved by the SAHPRA. Now the NFP suggests a meeting with the health minister to discuss a plan for how to utilize the treatment to help many in that nation of nearly 60 million. Many of this population are poor and again while much of Sub-Saharan Africa has been mostly spared the brunt of the pandemic, South Africa is in a far more precarious situation.
How could a common drug used in many parts of Africa with a well-known safety profile be at the center of such political controversy? Welcome to the world of power, politics, and drugs, at the confluence of human material interests and healthcare, that’s been provoked, even exaggerated by this pandemic.
The NFP has given the health agency until this Wednesday 6 January to have talks or go to courts at the High Court of SA for “urgent relief,” according to Independent Online. Meanwhile, the NFP and its affiliates in politics in this southern most African country slam the health minister for incompetence in the COVID-19 vaccine rollout strategy, blaming the government for dragging its feet in vaccine procurement.
A recent oppositional spokesperson from the Cosatu, Sizwe Pamla stated, “What the minister presented is bunk and the country should not accept it. South Africans are familiar with the egregious policy failures, with deadly consequences, as we saw with the mismanagement of the AIDS pandemic.” This individual went on to essentially declare the government of simply engaging in “public relations exercises.” In defense of the South African government, many other governments were too caught flat footed in this whole pandemic.