Clinical Trials and Research Roundup | South Africa: SAHPRA Bans Ivermectin with Criminal Liability

South African Health Products Regulatory Authority (SAHPRA) Bans Ivermectin with Criminal Liability:
The South African Health Products Regulatory Authority (SAHPRA) has banned the importation of Ivermectin into the country. Now Ivermectin has been Used to treat people and animals against parasites for decades now, the drug has been hailed as a revolutionary regimen since the 1980s: since then, billions of people primarily in the tropics have been treated, and consequently, a well-known safety profile emerged. However, with growing chatter about the benefits of the drug in relation to COVID-19 (based on dozens of case series, observational and randomized controlled studies), Dr. Boitumelo, SAHPRA’s chief executive, recently declared, “Our stance is unambiguous. This drug is not approved by SAPHRA, and any attempt to import it into the country will be dealt with by SAHPRA’s regulatory compliance unit in conjunction with law enforcement agencies such as SAPS and the SIU.” Moreover, the regulatory head pointed at a whistleblower contact to the public should anybody be aware of such activity. Given the drug’s pervasive use throughout the African continent to fight parasitic infection, this move is strange. The timing comes just when mounting data points to the possible benefits of the drug. Why wouldn’t the regulatory head want to at least investigate the findings? Why an outright ban with criminal liability? What are they afraid of?

Boom in Avifavir (Favipiravir) Demand to Treat COVID-19 Cases in Russia leads to Halt on All Exports:
Russia’s Direct Investment Fund (RDIF), an active participant in funding the development of therapies and vaccines for that nation in response to the pandemic, recently put a halt on exports of that country’s generic version of the antiviral drug favipiravir known under the trade name Avifavir. The first such Favipiravir-based drug approved to treat COVID-19, Avifavir is the third Favipiravir-based product authorized in Russia for targeting early onset mild to moderate COVID-19. As with Russia, multiple companies in India market Favipiravir-based products targeting COVID-19. With the upswing in COVID-19 cases driven by the second wave of the pandemic, demand soared for the product, according to the RDIF. Consequently, the Russian financial representative now halts all exports, allowing distribution only within Russia until the manufacturers can ramp up further capacity and surplus product to catch up with demand. Up until now, they had exported the drug to 15 nations.

UCLA Leading Statewide Effort to Open Up Communities at Risk for Vaccination & Treatment:
UCLA, leads a coalition of 11 academic institutions and their community partners across California were afforded the opportunity a couple months ago to develop a statewide community-engaged approach to addressing COVID-19 among populations that are disproportionately affected by COVID-19. To help bring more research engagement to targeted communities the group of 11 research centers, again led by UCLA, were granted $4.1 million from the National Institutes of Health (NIH) for the statewide program. Known as the COVID-19 California Alliance (STOP COVID-19 CA), this is part of a broader NIH Community Engagement Alliance Against COVID-19 Disparities. This partnership represents a joint effort among five UC medical campuses, two additional UC campuses and four other leading academic institutions in California.

Responses

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  1. Abhorrent. Shame on South African authorities for trying to deprive people of an essential medicine for Covid-19. And shame on them for attempting to get people to snitch on others who are simply trying to survive when sickened by this virus. What’s next? Work camps for offenders? They clearly do not care that they’re handing many a death sentence with this arrogant and ignorant policy in “banning ivermectin.” Please let us know when you can what has prompted such a bone-headed policy. Thanks, TSN for your reporting.

  2. Although some governments have started to test Stromectol (ivermectin) and might even have endorsed it, India has dropped it from its treatment protocol for COVID-19:
    https://www.indiatvnews.com/news/india/ivermectin-drug-not-included-centre-covid-19-management-protocol-659148

    Stromectol (ivermectin) has only a mediocre safety profile:
    https://en.wikipedia.org/wiki/Ivermectin#Contraindications

    Meanwhile, Alinia (nitazoxanide) has a very good safety profile like Avigan (favipiravir), Foistar (camostat), and artemisinin, all of which have shown moderately good efficacy against early COVID-19:
    https://en.wikipedia.org/wiki/Nitazoxanide#Clinical_trials
    https://pubmed.ncbi.nlm.nih.gov/33031085/
    https://pubmed.ncbi.nlm.nih.gov/32725286/
    https://www.medrxiv.org/content/10.1101/2020.10.21.20217208v1

    Foistar (camostat):
    https://www.medrxiv.org/content/10.1101/2020.12.10.20240689v1
    https://pbs.twimg.com/media/EURFxodXsAEIsIQ.jpg:large
    https://livedoor.blogimg.jp/toua2chdqn/imgs/4/6/4606c81f.jpg

    Artemisinin:
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7605811/
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7572038/

    Meanwhile, Alzumab (itolizumab) has a very good safety profile like Actemra (tocilizumab) and both drugs have shown moderately good efficacy against mid-stage and end-stage COVID-19:
    https://www.medrxiv.org/content/10.1101/2020.12.01.20239574v1
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7688906/
    https://immunityageing.biomedcentral.com/articles/10.1186/s12979-020-00207-8
    https://immunityageing.biomedcentral.com/articles/10.1186/s12979-020-00207-8/figures/2