Pressure on SA regulator to authorise Ivermectin for immediate use

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The South African Health Products Authority (SAHPRA) is facing pressure, including the threat of a court challenge, to authorise for immediate use the antiparasitic drug Ivermectin, reports MedicalBrief. As the second wave of the pandemic has grown, there have been calls, both locally and internationally, for the drug to be cleared for use, despite large-scale clinical trials not yet having been conducted.

The National Freedom Party has threatened to take the government to court over the matter.  IoL reports that NFP MP Ahmed Munzoor Shaik Emam said the party was prepared to wage a legal battle if the government refused to do so. “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,” Shaik Emam said.

In a a written response to Emam’s attorneyss, Subrayan Naidoo, the Health Department said it noted “your threat to approach the courts”, adding its position on the matter had been clarified in other correspondence, “therefore any urgent court application will be regarded as frivolous. The department will therefore oppose same and further seek a punitive cost order. We hope this will not be necessary.”

The department letter said it was “quite unusual” for a member of parliament and of the health portfolio committee, to which Mkhize reports, to write to him via a lawyer. Instead he should have requested the minister appear before the committee to raise specific issues and concerns.

It also pointed out that the Health Department dis not have the authority to license and register medicines. “This a SAHPRA process. If your client has lodged this application with SAHPRA, please share with us such correspondence and the standard acknowledgment letter from SAHPRA so we can follow up on progress made.”

In a separate report, SABC News quotes a specialist at the Lenmed Shifaa Hospital Dr Farida Amod, as saying while the vaccine is being procured, Ivermectin can help to reduce the number of coronavirus infections and COVID-19 related deaths.

“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. So, to use re-purposed drugs like Ivermectin is an excellent idea.” Amod says the drug should not be replaced by the vaccine.

SAHPRA has said it had not approved Invermectin, and that any attempt to import it to South Africa would be illegal. “Ivermectin is not indicated nor approved by SAHPRA for use in humans. There is no confirmatory data on Ivermectin available as yet for its use in the management of COVID-19 infections,” SAHPRA said.

 

The Times reports that 11 clinicians, public health specialists, community health workers and medical scientists called the Ivermectin Interest Group (IIG), also believe the drug could potentially save thousands of lives and the government millions of rand to “mitigate the affect of the pandemic until such time as we can roll out a comprehensive vaccination programme”.

On 2 January, the IIG sent a 41-page dossier to health minister Dr Zweli Mkhize to “accelerate research of Ivermectin and fully explore its potential in the COVID-19 response in a responsible way”.

University of KwaZulu-Natal (UKZN) medical scientist Prof Colleen Aldous said the motivation advocating science was in response to the crisis of the epidemic that was being compounded by the SARS-COV-2 variant N501Y.

The group said that given the uncertainty around the rollout of the vaccine, “a critical issue to consider is that we need to roll the vaccine out to more than 60% of the population before herd immunity snuffles the disease out. This could take several months – not enough time to prevent a third wave”.

The group noted that while the use of the drug was controversial for “sound scientific reasons”, they highlighted promising research by Dr Andrew Hill Sr, a respected academic and World Health Organisation (WHO) researcher who has been tasked, as part of the Unitaid ACT Accelerator initiative, to improve access to COVID-19 treatments and diagnostics.

However, The Times reports, SAHPRA is not convinced. “Ivermectin has made headlines recently as a so-called ‘miracle cure’ for COVID-19. However, 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,” said CEO Dr Boitumelo Semete-Makokotlela.

Key findings of a department of health review document, dated 21 December 2020, to investigate whether the drug should be used in the management of COVID-19 patients compared to no intervention or as an alternate intervention, found that the “evidence of efficacy and safety is very uncertain, early phase studies were of very low quality and there is very low certainty evidence”.

The recommendation was that Ivermectin not be used for adults with COVID-19 and that eligible patients with COVID-19 should be considered for enrolment in relevant therapeutic trials.

The report says the review document noted that while Ivermectin is not approved globally as an antiviral agent or registered in South Africa for human consumption it could be accessed via section 21 approval. The document said common side-effects associated with Ivermectin are diarrhoea, nausea, abdominal pain, fatigue, somnolence and dizziness, and that while it had considered the review by Kory’s alliance, this was insufficient. It noted that as of 21 December, 37 registered clinical trials investigating the drug had been completed but results were yet to be published.

 

MedicalBrief notes that health experts elsewhere are also urging global health authorities to examine the positive data on Ivermectin. A report in Healio writes that “numerous studies” have provided evidence supporting the use of Ivermectin to prevent and treat COVID-19, according to the Frontline COVID-19 Critical Care Alliance. Dr Paul Marik, founder of the alliance and a professor and chief of the division of pulmonary and critical care medicine at Eastern Virginia Medical School, said that Ivermectin “is a safe drug that is exceedingly cheap”. He added that “what is truly remarkable – this was a gift to us – Ivermectin has high activity against COVID-19”.

Ivermectin is a key factor in the alliance’s I-MASK+ protocol for prophylaxis and early treatment of outpatients with COVID-19. In the protocol, those at high risk for COVID-19 infection receive Ivermectin at 0.2 mg/kg on day 1 and day 3, and weekly for 4 weeks; those who were exposed to COVID-19 receive the same dose at day 1 and day 3; and both groups receive daily doses of vitamin D3, vitamin C, quercetin, zinc and melatonin. For early outpatients with COVID-19, the protocol calls for one dose of Ivermectin at 0.2 mg/kg at day 1 and day 3, along with the same daily vitamins and 325 mg per day of aspirin.

Marik said that much of the data available on Ivermectin in the treatment and prevention of COVID-19 has been published since August, which was the last time the NIH updated its recommendations for the novel coronavirus. Thus far, Marik said, studies have indicated that Ivermectin has demonstrated efficacy in preventing COVID-19 infection prior to and after exposure to COVID-19. He also said that it has been shown to effectively treat the virus in the early symptomatic stages and among patients hospitalised with COVID-19.

In a review of the literature, Marik and colleagues detailed all available clinical trial results on Ivermectin in COVID-19 and concluded that the drug has benefits in preventing and treating COVID-19 infection.

For instance, Healio reports Marik and colleagues noted that a randomised controlled trial in Egypt found that among health care and household contacts of COVID-19 patients, just 2% of those who received Ivermectin and wore PPE tested positive for the novel coronavirus, compared with 10% of contacts who were only given PPE.

Marik and colleagues also described a randomised controlled trial of hospitalised patients that was done concurrently with the prophylaxis study. The trial included 400 patients split into four groups – two consisting of patients with mild to moderate illness and two consisting of severely ill patients. Patients with mild to moderate illness received one dose of Ivermectin per day in addition to standard care or hydroxychloroquine twice a day in addition to standard care. The researchers determined that the rate of illness progression was significantly lower among those who received Ivermectin (1% vs. 22%). Severely ill patients were assigned to receive standard care plus Ivermectin or hydroxychloroquine. The researchers determined that in addition to lower rates of COVID-19 illness progression in the Ivermectin group (4% vs. 30%), the Ivermectin group also had a lower mortality rate (2% vs. 20%).

Dr Pierre Kory, an associate professor of medicine and a critical care physician at St Luke’s Medical Centre in Milwaukee, Wisconsin, said that in the days since their review was written, even more studies have been published supporting the use of Ivermectin in patients with COVID-19. “All studies showed positive benefits – the majority showed a decrease in mortality, decreases in hospitalisation,” Kory said.

In light of the positive data on Ivermectin in COVID-19, the researchers called on national and global health authorities – including the NIH, WHO and the CDC – to examine the data. “We are appealing to these national and global health authorities,” Marik said. “Please, review the data, and provide guidance to health care workers across the world so that they can prescribe this medication.”

 

Full IoL report

 

Full SABC New report

 

Full report in The Times

 

Full Healio report

 

See also from MedicalBrief’s Archives

5-day course of ivermectin may reduce duration of COVID-19

 

Ivermectin stops SARS-CoV-2 virus growing in cell culture within 48 hours

 

Lower mortality for hospitalised COVID-19 patients taking Ivermectin – ICON study

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