A group of doctors, including a Silverton medical practitioner, will meet the government in court on February 2 in a legal bid to have Ivermectin approved for the treatment of Covid-19 patients. Dr George Coetzee, among others, as well as lobby group AfriForum, filed papers in the Gauteng High Court, Pretoria, against Health Minister Dr Zweli Mkhize and the South African Health Products Regulatory Authority.
They are, among others, asking the court for an urgent order to ensure that Ivermectin developed for human consumption is available to doctors who want to prescribe it to treat Covid-19. They said the regulator have until now failed to approve applications by doctors – which were brought in terms of Section 21 of the Medicines and Related Substances Act – to have Ivermectin approved for the treatment of Covid-19 patients.
They are asking the court to review and set aside the failure of the regulatory authority to approve the Section 21 applications and to order that Ivermectin is a safe drug for use by humans. This, they say, is subject to it being properly administered in a controlled manner under the management of a treating medical practitioner.
The applicants will also ask for a declaratory order that qualified medical doctors and pharmacists are entitled in terms of the Medicines Act to compound medicine on the prescription of a medical practitioner, which includes Ivermectin.
“We find ourselves in extraordinary circumstances. People die every day and health-care practitioners are inundated. Every day costs more lives,” said Barend Uys, AfriForum’s head of research. He added that under these circumstances the potential risks and benefits of a decision should be weighed with urgency, and actions should be decisive. He said Ivermectin was listed by the World Health Organization as an essential medicine and has been proven safe, also in children.
“Studies undertaken in, among others, the US, Argentina, India, Egypt and Spain all show that Ivermectin has the potential to treat Covid-19 and reduce deaths. The balance between risk and benefit is evident. This is why we are taking these steps to ensure its availability. According to the applicants, farmers are the largest consumers of veterinary medicine that contains Ivermectin. More and more people are using these products, which creates challenges to farmers in terms of availability and affordability.
The Health Products Regulatory Authority has banned this medication, of which 3.7 billion dosages were already distributed.
Although Ivermectin has been available for human consumption in several countries for many years, it is only available in South Africa as a livestock drug.
AfriForum said this drug may be the answer to fighting Covid-19 as it was widely available and affordable. It is irrational to approve the use of a vaccine that has been developed within months and at the same time ban the use of a drug proven to be safe that has been in use for four decades. The reality is that many citizens are turning to livestock drugs without the guidance of medical practitioners for the treatment and prevention of Covid-19. The approval of Ivermectin in tablet form that was developed for human consumption is the only way to counter the danger of overdosing that currently exists with the use of the liquid livestock drug.
SAHPRA stated: Ivermectin is a widely used drug for the treatment and control of parasites in animals and is used to treat several tropical diseases in humans not commonly seen in South Africa, as well as scabies and head lice. Ivermectin is a synthetic derivative of the antiparasitic class of compounds known as avermectins. Millions of people have already used this medication against riverblindness with great success.
In South Africa ivermectin is registered for use under Act 36 of 1947 (Department of Agriculture) for use in animals. This means that veterinarians and other trained personnel are allowed to prescribe it as an antiparasitic agent for a variety of animals. The drug is not currently registered for human use, but SAHPRA occasionally grants Section 21 permits for the use of topical ivermectin as an unregistered product for the treatment of individual patients with conditions such as scabies or head lice.
Several investigators have reported that when tested in the laboratory, ivermectin inhibits replication of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Given the current coronavirus disease-19 (COVID-19) pandemic, this has understandably received a lot of media attention. Thus, several clinical studies have been undertaken to evaluate ivermectin’s efficacy in treating the COVID-19 infection.