Health products regulator not confident with risks, benefits of Ivermectin
Pretoria - Controversial “wonder drug” Ivermectin will soon be available to the public – albeit in a controlled manner – to treat Covid-19 patients.
The decision was taken by the health products regulator, taking into consideration the distress across all sectors of the country amid the pandemic.
South African Health Products Regulatory Authority (Sahpra) yesterday told the National Press Club the roll-out would be in a controlled yet accessible manner for people.
However, the regulator said it was not confident with the risks and benefits of the drug, but had taken note of the immense need for a solution and the availability of the Ivermectin in the country.
The regulator would nonetheless allow the distribution of the drug in a “compassionate use access controlled programme”, the regulator’s chief executive Dr Boitumelo Semete-Makokotlela said yesterday.
She said the country was in a situation where there were no other options. “We are saying we have heard you. We will facilitate access to enable proper use. We have engaged with the scientific community and have considered the risk benefits, and will very soon announce access protocols.”
Semete-Makokotlela reiterated that there was insufficient data on the treatment and prophylaxis properties on CoV-2 which caused the coronavirus, or on the benefits and harms of treatment and so they continued to encourage research into Ivermectin and its efficacy in human beings.
Board chairperson at the regulator Professor Helen Rees said their initial response to calls for the drug to be made available – which was to advise that it not be used – was in line with their role as the watchdog.
“Our primary responsibility is for the safety of South Africans to ensure they consume health products that are tried and tested and beneficial, and in the national context, we had to take into account evidence-based data.”
She said everyone had been working hard since the start of the pandemic to bring relief and the regulator’s dedicated committee had worked with clinic trials and international bodies to bring that to South Africans.
She said they were “concerned for the livelihoods of the people”. “We are acutely aware of the lack of options, and in the middle of everything, options will present themselves for us to scrutinise.
“We are all saying we want a vaccine and we want it rolled out soon as possible.”
According to Rees, there was no regulation in the country for the usability of Ivermectin, and in discussions with other countries across the world, they had found that a lot of them also did not use it.
“The compassionate use access programme is open to all patients; there will be no priority for any sector or any person,” Semete-Makokotlela said.
They would be working with doctors who will prescribe the drug, to gather information and knowledge on its effects, she said.
Rees emphasised that currently, information available for use in patients infected with coronavirus was simply insufficient for South Africa to prescribe it. “But because of the desperate situation on the ground, and because we do not have options, we will make it available. We will not simply unleash it onto society, we will make sure it is released in a safe and controlled way.”
Meanwhile, the court battle regarding use of the drug, known for use in animals and for certain illnesses in humans, will still go ahead.
AfriForum, which is at the forefront of the court action, said it welcomed the regulator’s approach as a step in the right direction. In this regard, the civil rights organisation said the approach was limited and therefore the legal challenge had to go on next week.
The urgent application is against the regulator and Health Minister Dr Zweli Mkhize.
In it, the applicants are seeking an order that Ivermectin be made available for doctors to prescribe it as treatment for their Covid-19 patients.