DURBAN - THE South African Health Products Regulatory Authority (Sahpra) revealed to the Parliamentary Portfolio Committee on Health that they were awaiting three clinical trial studies and that they have started authorising the use of ivermectin through their controlled compassionate use access programme.
Sahpra board chairperson Professor Helen Rees said safety was paramount in what they did.
“What we cannot say is that ivermectin saves lives,” said Rees.
She said a lot of drugs had been looked into, and that was when ivermectin entered the fray. Ivermectin looked like it had antiviral activity in the laboratory and looked as if it might have anti-inflammatory activities as well.
“A number of small studies have been done, and larger studies are in progress. The small ones either didn’t show or showed some hopeful impact but not sufficient for anybody to be able to say this definitely works. For that, you absolutely need large studies, and they have to be properly designed studies. Without that, you will not be able to interpret the data,” said Rees.
She said good evidence was necessary.
“Somewhere in the middle, we need to have a regulatory decision that protects people's safety and is very careful about not declaring things effective if we do not have the evidence,” said Rees.
Sahpra CEO Dr Boitumelo Semete said ivermectin was purported to be low cost, so when one looks at lab-based studies and small clinical trials, the cost is where there is interest for its use.
“There are clinical trials going on in different countries, but there are challenges with those trials. They are not standardised, not properly designed clinical trials, they are small, and not designed to do dose finding. Those alluded the gaps in the trails,” explained Semete.
She said as regulators, they were unable to make a decision because there was a gap in terms of the scientific information that was available.
However, they will continuously review any data that emerge and have already reviewed information from sources among others but not limited to the National Essential Medicines List Committee, World Health Organization and Ministerial Advisory Committee.
“Last week, we had a meeting with the scientific community, and are expecting about three clinical trial studies to be submitted by the University of the Free State, University of the Witwatersrand and Stellenbosch University,” said Semete.
Recently, Sahpra put together the controlled compassionate use access programme for ivermectin.
Semete said through the programme, they can ensure that the product was quality, it was available and stored in healthcare facilities that were authorised, as per the National Health Act, and know who the medical practitioner has given the product to, the dosage and if there were any side effects.
“We have received a number of applications since last week, and there's already a few that we’ve started to authorise (as of Tuesday night),” said Semete.
Rees added that there seemed to be a bit of confusion on what they do.
She said they were given a set of legislation and a set of rules. They have to ensure that all the stakeholders abide by the rules.
“The regulator has to ensure that medicines and health products in SA are safe, they are good quality, they work, and that they are for the benefit of our population. That is our mandate,” explained Rees.
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