Proponents of antiparasitic drug Ivermectin, which has been touted as a miracle drug and possible treatment for Covid-19, have been making a lot of noise about it again recently despite a lack of clinical trials on its use and effectiveness to treat the coronavirus.
The South African Health Products Regulatory Authority (Sahpra) has not approved Ivermectin for human use, citing issues around the lack and quality of existing trials. But a growing number of people are calling for its use in Covid-19 treatment globally and in South Africa.
The National Freedom Party (NFP) has said it is prepared to take the government to court if it doesn’t change its position on the use of Ivermectin. “Many people are dying and infections are averaging around 17 000 now. By the time this vaccine comes, many people will be dead. If there is proof around the world that this drug is working, we don’t understand why we are not using it,” NFP member of Parliament Ahmed Munzoor Shaik Emam is quoted as saying by news website IOL.
Social media has been awash with anecdotal stories about doctors using Ivermectin with some success and laypeople advocating for the use of the drug. Some health workers have called on the government to allow the use of it, too. The SABC quoted Farida Amod, a specialist at the Lenmed Shifa hospital in Durban, who said Ivermectin could help reduce Covid-19 infections.
“Ivermectin in some randomised controlled trials and in some epidemiologic settings where they’ve used it for mass programmes has been shown to have been very positive. So I think when you have a situation where the need is so dire and immediate, we can’t wait for new drugs because that takes time,” Amod said.
But as the health regulatory authority has said repeatedly: “Sahpra’s stance is unambiguous. This drug is not approved by Sahpra and any attempt to import this drug into the country will be perceived as being unlawful.”
Arrested and charged
On Thursday 7 January, the South African Police Service arrested a 43-year-old man at King Shaka International Airport in Durban who had flown into the country from Dubai. He was found with 2 464 Ivermectin tablets worth around R100 000 in his hand luggage.
Police spokesperson Colonel Athlenda Mathe said the man would be applying for bail in the Verulam magistrate’s court the next day. He was charged with possessing unregistered medicines and importing medicines without a valid permit.
Sahpra has been clear on its stance on Ivermectin and the lack of reliable data. “There is no confirmatory data on Ivermectin available as yet for its use in the management of Covd-19 infections. In terms of safety and efficacy, there is no evidence to support the use of Ivermectin and we do not have any clinical trial evidence to justify its use.”
The regulatory body said it encouraged and supported well-designed, ethically approved, scientific studies designed to identify new or existing medicines to treat Covid-19.
“Sahpra reiterates its commitment to expedite the review of such studies. Furthermore, as the South African regulatory authority, Sahpra will continue to evaluate any emerging peer-reviewed publications or data on the use of Ivermectin for the treatment of Covid-19, and notes that according to the global clinical trials register, additional data should become available in the course of the next few months.”
‘Shiny new things’
Francois Venter, the deputy executive director of the Wits Reproductive Health and HIV Institute at the University of the Witwatersrand and a leading expert in virology, said medical doctors tended to “love shiny new things”.
“We need data with good clinical input,” he said, in support of Sahpra’s decision not to approve the use of Ivermectin. “Simply because some idiot doctor decided to give it to someone illegally and it worked … you know, most people get better with Covid. So somebody saying they gave it to someone and they got better, well, they will get better anyway.
“Your miracle drug might be doing absolutely nothing. In fact, it might cause harm. Like chloroquine for instance, where it just didn’t work and in some cases it actually could have caused harm. It’s really reckless to my mind to be rushing towards this without the adequate efficacy studies and safety studies in the local population.”
Venter pointed to work done by Andrew Hill, a senior visiting research fellow in the pharmacology department at Liverpool University who recently presented a meta-analysis of a number of randomised clinical trials of Ivermectin to treat Covid-19.
“The trials are all in the region of 100 to 500 patients maximum and no individual clinical trial is large enough to clearly establish efficacy. But the combined data from all the available clinical trials might be large enough to assess the clinical efficacy reliably and to get to a WHO [World Health Organization] recommendation for the treatment being used worldwide,” said Hill in a presentation.
He said there were some promising signs looking at the meta-analysis of the early trials, but pointed to limitations such as small sample sizes and the potential for publication bias in looking for positive or better trials. He also noted the range of dosages used in the various trials.
Despite positive signs, Hill emphasised the importance of including more clinical trials to confirm the benefits and agree on an optimised dose of Ivermectin.
Venter added: “There are no shortcuts. You don’t get to go from it works well in the Petri dish to mass rollouts in humans. There is a whole list of safety and efficacy you have to do. There are no massive shortcuts.
“We can do those studies, but it is a question of money. Medical studies are not cheap to do. Everyone is like, ‘Oh, no, we’ll just fast-track it and give it to people anyway.’ The bottom line is it’s very promising but it’s reckless to just hand it out to people.”