SA’s medicines regulator certainly took its time to scrap a controversial programme that permitted doctors and hospitals to import from countries that had approved the antiparasitic drug ivermectin for use in patients with Covid-19.
But the decision by the SA Health Products Regulatory Authority (Sahpra) earlier this week is most welcome. Sahpra also advised doctors to stop prescribing it to patients.
The drug, which is used to treat parasites mainly in livestock, was thrown into the spotlight in the early stages of the coronavirus pandemic when misleading information — at times peddled by medical doctors, celebrities and scientists — suggested it is safe to use and effective against Covid-19.
With vaccines still in development at the time and Covid-19 cases multiplying, medical misinformation on social media and messaging platforms about the drug spread like wildfire. That laid the groundwork for the rapid growth of the black market as desperate and panicking South Africans turned to self-medicating with the falsely touted miracle cure.
Since the beginning of 2020, authorities in SA and elsewhere in the world have seized millions of rand worth in illegal trafficked ivermectin.
Under the “compassionate access” programme introduced in January 2021, Sahpra authorised 372 healthcare facilities to import bulk supplies of ivermectin and received 628 applications from healthcare professionals for permission for specific patients to use the drug, but few complied with the regulator’s reporting requirements.
One might ask, why did Sahpra decide to introduce the programme? The reason is simple and well grounded: it hoped this would give it greater oversight of its use. In addition to obtaining permission to import the drug, doctors and hospitals were required to report back to the regulator on how their patients fared.
Furthermore, there was no scientific consensus about the benefits of the drug, with some scientists early in the pandemic putting out papers suggesting it could be a candidate for treating Covid-19 given its antiviral prospects.
Things have changed since then.
“The studies that suggested potential efficacy of ivermectin in the prevention and treatment of Covid-19 and which motivated the adoption of the programme have since been retracted,” according to Sahpra’s statement, which also cited the findings against the use of the drug in treating Covid-19 in two large trials conducted in 2021.
While both the US Food and Drug Administration and the World Health Organization have advised against the use of ivermectin except in clinical trials, it may be difficult to sustain such a position as an increasing number of clinical trials show the drug is useless against respiratory disease.
The latest large study, by researchers at Canada’s McMaster University, should help put to rest the debate about the efficacy of ivermectin in treating Covid-19. As reported by The Wall Street Journal, the researchers looked at more than 1,300 adults in the Minas Gerais region of Brazil — where President Jair Bolsonaro was the drug’s biggest cheerleader — with Covid-19 symptoms. The patients were all at risk of having a severe case for reasons including a history of diabetes, hypertension, cardiovascular disease or lung disease.
It would have also been hard for Sahpra to maintain the programme after the health department’s essential medicines list committee on Covid-19 took a similar stance in July 2021. The department said many of the published clinical trials were of such poor quality that it limited the strength of their conclusions on ivermectin, and what little evidence there was did not suggest any clear benefit.
Yes, it is still possible for people to obtain the drug through illicit use of the legally approved product for animal use. Compounding pharmacies can still make the drug on their own premises, by using ingredients that are legally imported to make Soolantra, a topical cream used to treat the skin condition rosacea.
But Sahpra’s decision is an important step forward in fighting unproven claims about the drug that have given people a false sense of security against the virus.
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