Ivermectin lobby groups have welcomed the regulator’s decision to allow compassionate controlled access to the drug as a step in the right direction but have raised concern that it does not go far enough to make the drug easily accessible2020. (Photo by Luis ROBAYO / AFP)
Durban - Doctors and scientists who have been lobbying the government to allow the universal use of ivermectin as a prophylaxis and treatment for Covid-19 say they are “cautiously optimistic” about the SA Health Products Regulatory Authority’s (Sahpra) decision to permit “compassionate, controlled” access to the drug.
Sahpra chief executive Dr Boitumelo Semete-Makokotlela announced the decision at a media briefing yesterday, saying the regulator would be processing applications from doctors under Section 21 of the Medicines and Related Substances Act, to prescribe the drug for the treatment of Covid-19 patients.
However, Semete-Makokotlela said Sahpra had reviewed the scientific data and agreed with other global health authorities such as the US Food and Drug Administration and EU Medicines Agency and the UK’s Medicines and Healthcare Products Regulatory Agency that there was not sufficient evidence to prove its efficacy or non-efficacy in treating Covid-19.
“We have listened and we have heard. We have engaged scientists and we have had discussions internally. We acknowledge there is some positive trend noted but there is insufficient data for a regulator to make a decision. We as Sahpra have considered all of this, where we are in the context of the second wave lives are being lost and we have had many practitioners reaching out to us as a regulator,” she said.
“The approach we will be taking as we go forward is we will have a controlled, compassionate access programme. As a regulator, we had to have very in-depth discussions regarding the pandemic with limited options being available, and on that basis we will introduce a compassionate, controlled access programme (CCAP) to enable us to monitor the use and allow health-care practitioners to report to us. We will communicate this in next day or so with very clear guidelines as to what this control will look like” she said.
Professor Colleen Aldous, a member of the Ivermectin Interest Group which comprises doctors, scientists and pharmacists that submitted a Section 21 application to the regulator asking for permission for all doctors to be able to prescribe the drug to all patients, said the regulator had engaged with society’s pleas.
“While we still differ with Sahpra on the view that the evidence is inadequate on the safety and efficacy of ivermectin, we are cautiously optimistic about the CCAP that Sahpra are putting forward. It certainly is a step forward to getting the drug to be available in the country,” Aldous said.
“We need to wait for Sahpra to release their guidelines for the CCAP. Traditionally a CCAP is very restrictive, but a Section 21 application also is onerous. In an expanded compassionate access programme model, a clinician requests a drug for a named individual patient based on a specific clinical access guidance document,” she said.
“The guidelines may take into account the resources to manage all the applications in the current context of the pandemic. What we want to ensure is that all doctors who wish to can prescribe ivermectin to whichever patient they feel requires the drug, and we hope the terms of the CCAP will facilitate this,” she said.
South Africa has a Right to Ivermectin (Sahari) founder and spokesperson Shabnum Palesa Mohamed said the group acknowledged the decision “with interest”.
She said the 60 000-strong civil society organisation believed that while it was “one step in the right direction”, it was “simply inadequate during a devastating pandemic”.
She said the US-based National Institutes for Health had described ivermectin as a drug that had “continually proved to be astonishingly safe for human use”.
The Mercury
Related Topics: