South Africa

GROUNDUP

Ivermectin returned to the worms by SA medicines regulator

Ivermectin is great for treating some kinds of worm infections. It’s useless against Covid. (Photo: shutterstock / Wikipedia)

Controversial drug no longer permitted for use against Covid.

The use of ivermectin to treat Covid has been terminated by the medicines regulator.

The South African Health Products Regulatory Authority (Sahpra) announced on Monday that the special dispensation granted for the use of ivermectin has been terminated, after a review of evidence.

Sahpra states that “there is currently no credible evidence to support a therapeutic role for ivermectin in Covid”. It cites a surfeit of evidence supporting the opinion that ivermectin is of no clinical use for the prevention or treatment of Covid.

Last year, ivermectin was at the centre of an international storm when it was touted as a magic bullet for the prevention and treatment of Covid.

As GroundUp reported at the time, researchers had found some grounds for optimism across a series of studies. At a time when access to vaccines was far from guaranteed, there was an understandable clamour to test many different treatments, even unlikely ones.

But the drug — which is excellent for the treatment of parasitic worms — quickly became politicised.

Afriforum launched a court campaign to force Sahpra to approve the use of ivermectin for Covid.

In January 2021, Sahpra settled with Afriforum. Under the terms of the settlement, the drug was made available to anyone who applied to use it under Sahpra’s section 21 process.

Scientists (writing for GroundUp) criticised the settlement, as there was not enough evidence to support its use. To the contrary, as the year progressed, studies piled up showing that ivermectin was not an effective treatment or means to prevent the virus.

Moreover, studies and a meta-analysis that supported the use of ivermectin for the prevention and treatment of Covid (and were cited by its proponents) were withdrawn, after ethical violations were found and it was revealed that fraudulent data was used in key studies.

As noted in Sahpra’s statement, the hype around the drug has vanished. Since August 2021, there has been a “marked decline” in the number of healthcare facilities applying to hold ivermectin, and there have been no approved individual applications to use ivermectin since December. Sahpra also noted a lack of reporting on the outcomes of ivermectin treatment from healthcare providers (which is required in terms of the settlement agreement).

With the termination of the programme, importing unregistered ivermectin products will not be allowed; and health facilities will not be allowed to hold bulk stock of unregistered ivermectin products. Doctors who have prescribed ivermectin for Covid will still be expected to report to Sahpra on the outcomes of the treatment. DM

First published by GroundUp.

 

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  • And every single one of SAHPRA’s arguments will now be dismantled in court. As for your scientists Groundup, certain of them are as financially and academically conflicted in their ‘findings’ and opinions on this drug as SAHPRA and as the other healthcare journalism platform given free reign on DM. A liberty it has used to post several articles maligning this drug. Whether GPs or ICU professors, those treating with and advocating for the drug as part of a multi-drug, early treatment protocol have never been the anti-vax brigade they’re made out to be. They were and remain simply – pro-treatment. It is not a binary choice. And if GroundUp, Bhekisisa or DM had the professional even-handedness to interview these doctors about their clinical treatment of patients – I can guarantee your/ their journalists would come away with a wholly different and better informed point of view. Why are you/ they afraid of first-hand, clinical, scientific knowledge from those actually treating the virus?

    • Please can you latter day Galileos give it up? What is it about studies showing no benefit that you don’t understand.
      As Churchill said, a bore never changes his mind, or the subject.

      • Logesh, Churchill also had a keen interest in intrigues that successfully muddy the waters to achieve a strategic end. That being the discrediting of the generic treatment option as an existential threat to the for-profit drug lobby. As will soon be borne out in court, the FDA qualified their own findings of early 2021 by stating they hadn’t even looked at the data on this drug as a Covid treatment. As regards the 2 trials SAHPRA cite, the Together Trial underpowered the drug’s standard 5 day course of treatment to 3 days and thereby by 40%. The I-TECH trial allowed for 5 days but none of the zinc, vitamin-D and anti-biotic adjuvants which form the basis of every treating doctor’s multi-drug protocol worldwide. Like ARVs to treat HIV, no one uses a silver bullet but a multi-drug anti-viral protocol. If you watch the webinar of the NEMLC’s takedown of the meta-analysis on this drug you are unlikely to see a more radioactively partisan treatment of a subject which should attract nothing but objective scientific assessment. As for Dr. Hill’s retraction, SAHPRA’s refusal at any point to offer proof of their own, independent analysis of the drug and The WHO’s stand of ‘insufficiency’, watch the High Court for news.

        • No need for court. Read..”after ethical violations were found and it was revealed that fraudulent data was used in key studies.” Sahpra also noted a lack of reporting on the outcomes of ivermectin treatment from healthcare providers (which is required in terms of the settlement agreement). The evidence is up for acceptance that this drug was never designed to cure viral infections. Looking at the molecular structure no-one can explain how this drug will ever prevent entry into the cell by binding tot the ACE receptors. There is 80 Inceftive Disease Specialists in this country and they are not using the drug for good reasons.

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