Durban - A GROUP of doctors, clinicians, pharmacists, public health specialists and scientists interested in exploring the potential of Ivermectin to prevent and treat Covid-19 has lodged an application with the SA Health Products Regulatory Authority (Sahpra) seeking permission for all doctors to prescribe the drug to their patients.
UKZN healthcare scientist, Professor Colleen Aldous, one of at least 20 professionals across the country, who formed the Ivermectin Interest Group (IIG), said the team had last Friday filed a section 21 application in terms of the Medicines and Related Substances Act, seeking for doctors to be allowed to prescribe Ivermectin.
The application comes as reports of the drug’s alleged availability on the black market for anything from R100 to R200 per capsule have emerged.
“We applied under section 21 but we applied for all doctors in the country to be able to prescribe it to all patients because there were only two options given to us – a section 21 application or a randomised trial which is totally impractical,” Aldous said.
“A section 21 application usually involves one doctor applying for permission to prescribe Ivermectin to one patient but we took a totally different tack.”
Aldous said Sahpra had not rejected the application, which comprised an extensive document detailing scientific evidence regarding the use of the drug, but had on Monday asked the group to provide additional information.
Dr Warren Parker, a public health specialist, Dr Martin Gill, an ear nose and throat surgeon and Aldous said in a statement in response to the Ministerial Advisory Commitee’s memorandum on the use of Ivermectin for the treatment of Covid-19, that re-purposing of drugs found to be safe and effective for treating other conditions was a “scientifically valid pathway for Covid-19 prevention and treatment”.
“It is well established that non-medically supervised and self-medication is occurring, that profiteering is occurring through informal distribution networks, and that drug formulations and sources are uncontrolled. This trend is not readily undone, and it would be preferable to steer towards medical supervision and safe distribution of the drug in parallel to fast-tracking regulatory processes,” the doctors said.
The doctors said misinformation, disinformation and ill-informed use of unproven therapeutics undermined effective control of the Covid-19 pandemic and could lead to increased infection, illness and death.
“Political, economic and other vested interests as well as ignorance and ill-informed communication, have contributed to a number of drugs being promoted and used without adequate evidence and leading to significant harm at public and individual levels,” they said.
However, they said human use formulations of Ivermectin had been approved by the World Health Organization (WHO) for the treatment of parasitic worms and scabies.
“The drug has been widely and effectively used for this purpose globally and falls within the WHO’s rigorous safety guidelines at the prescribed formulations and dosages for treatment of these conditions. Ivermectin is unique in that it possesses both anti-viral and anti-inflammatory properties,” the doctors said.
“There are a growing number of studies that suggest that Ivermectin is effective for the prevention and treatment of Covid-19 in medically controlled and supervised circumstances. Small-scale studies and peer-reviewed analyses in research journals support the understanding that Ivermectin reduces the number of new cases of Covid-19 and reduces illness and death in Covid-19 patients.” they said.
“While it is well-recognised that robust randomised controlled trials establish the absolute benefits and safety profile of drugs for the prevention and treatment of diseases, the time frame of studies requires far more time than is available in the context of the rapidly advancing Covid-19 epidemic.
“In our view, totality of evidence to date – a combination of small-scale trials and peer reviewed studies and analysis – very strongly support urgently pursuing the potential widespread use of Ivermectin in South Africa, and immediate use under medical supervision which can be allowed on in terms of Section 21.
According to the doctors, Ivermectin has been approved for use at province level in Argentina, at the state level in India and country-level in Belize and Macedonia, while possible use was being explored in the US and Australia.
Members of the IIG co-hosted a webinar on Tuesday which focused on the scientific evidence for the use of Ivermectin in the treatment of Covid-19. Dr Andrew Hill of the University of Liverpool’s department of molecular and clinical pharmacology and advisor to the WHO and the Bill and Melinda Gates Foundation presented his personal views regarding his analysis of a host of international studies on the efficacy of Ivermectin in the treatment of the Covid-19.
He said a meta-analysis of 18 randomised trials involving 2 294 subjects showed Ivermectin had been associated with “faster time to viral clearance, shorter duration of hospitalisation, higher rates of clinical recovery and a 75% improvement in survival rates”.
He said by April 21 there would be a total of 27 trials covering 10 000 patients completed globally.
Sahpra spokesperson Yuven Gounden said he could neither confirm nor deny receipt of the application as it was “a confidential process”.