Doc’s plea for ‘wonder drug’

A Pretoria doctor who’s approached the courts in a desperate bid to have ivermectin approved for use in Covid-19 patients in South Africa, says the “wonder drug” could mean the difference between life and death for two men he is currently treating for the virus.

In papers filed in the High Court in Pretoria late last week, Dr George Coetzee argued his patients required the medication urgently.

“The denial thereof may well cause the demise of both,” Coetzee said – adding that he had already lost one patient to the virus.

“Had ivermectin been timeously administered, he may have survived,” Coetzee said.

Dr Neelaveni Padayachee – a senior lecturer at the University of the Witwatersrand’s clinical pharmacy department – said authorities were in a difficult position.

While the research at this stage was promising, it was by no means conclusive, she said.

“There are a lot of clinical trials going on at the moment but there’s nothing conclusive that’s come out to definitively say it’s going to work,” Padayachee said.

“We are holding our breath and praying that it does come through. But unfortunately at the moment, the clinical evidence is not there”.

ALSO READ: University of Free State prepares for clinical trial of Ivermectin

She said if the South African Health Products Regulatory Authority (Sahpra) were to give ivermectin its stamp of approval under these circumstances and there were adverse reactions reported down the line, it would have a serious case to answer to.

“It’s a huge risk to take from their side,” she said.

Coetzee – together with his two patients and Afrikaans lobby group AfriForum, all listed as applicants in the papers – want the court to declare ivermectin safe for use in humans and rule that doctors and pharmacists are entitled to prescribe it.

They also want the court to review and set aside the Sahpra’s failure to approve a number of applications Coetzee has made for special permits to administer ivermectin in terms of Section 21 of the Medicines and Related Substances Act.

An anti-parasitic, the drug has in recent months been touted as a potential treatment for Covid-19.

But while it’s registered for use in animals and humans against parasites in SA, it has yet to get the nod for use against Covid-19.

Sahpra has raised concerns about the limited research available on ivermectin as a treatment for Covid-19 but this month said it “encourages and supports all well-designed, ethically approved, scientific studies designed to identify new or existing medicines that are used for the treatment or prophylaxis of Covid-19”.

And at the weekend, the University of the Free State announced it was preparing for what could potentially be the first
such study involving ivermectin in South Africa.

READ MORE: Doctors lobbying for Ivermectin must approach Sahpra to run clinical trials – Mkhize

But Coetzee says there’s no time to waste and in his papers pointed to a recent review by the Frontline Covid-19 Critical Care Alliance – a group of expert critical care physicians and thought leaders – published last month.

In it, he said, the authors relied on existing data, which indicated ivermectin inhibited the replication “and binding to host tissue” of Covid-19 and had “potent anti-inflammatory properties”.

Coetzee said humans had been using the drug safely for decades in Central Africa, Latin America, India and South-East Asia – where it had proven highly effective for a range of ailments.

And he said Sahpra, itself, had in the past granted special permits for the use of topical ivermectin in SA to treat scabies and head lice.

“Under the prevailing circumstances it would be irrational to say the least, to allow the administration of ivermectin in the treatment of, inter alia, head lice, but to disallow it for purposes of treating Covid-19,” he said.

He described Sahpra’s insistence on new clinical trials as “ludicrous to say the least”.

“Clinical trials under these circumstances would be inhumane especially if such trials are conducted on critically ill patients who may benefit or have a better chance of survival if ivermectin is administered,” Coetzee said,

Neither Sahpra, nor the minister of health, responded to requests for comment yesterday.

– bernadettew@citizen.co.za

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