Consider anti-parasitic to avoid possible third Covid-19 wave, health minister urged
A politician and a group of scientists have separately thrown their weight behind a call for an anti-parasitic drug, being used to combat the transmission of Covid-19 in some quarters internationally, to be studied and considered for human consumption in SA.
The drug, Ivermectin, which was hailed as a revolutionary drug in the 1980s and works by paralysing and killing parasites including lice and worms in livestock, has been gaining traction as a “miracle cure” for Covid-19 patients.
However, the South African Health Products Regulatory Authority (Sahpra) banned the drug for human consumption on December 22 after it emerged on several social media platforms that the drug was being promoted on local groups as having “cured” people of Covid-19.
Some experts suggest that in patients who have tested positive for the virus, the drug inhibits viral loads and keeps those with early symptoms from progressing to the hyper-inflammatory phase of the disease, and even helps critically ill patients recover.
Now the two parties who have petitioned the minister — 11 clinicians, public health specialists, community health workers and medical scientists called the Ivermectin Interest Group (IIG), as well the National Freedom Party’s MP Ahmed Munzoor Shaik Emam — saying 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”.
However 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.
“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. In terms of safety and efficacy there is no evidence to support the use of Ivermectin and we do not have any clinical trial evidence to justify its use,” he said.
Sahpra said there was no clinical evidence available for the use of Ivermectin in the management of Covid-19 infections.
Government 'must explore every possible solution'
On January 2, the IIG penned 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 affect of the second wave is felt largely at the front line, namely at the general practitioner, clinic and hospital levels. Therefore, the country must explore every possible solution for Covid-19 prophylaxis and treatment to minimise morbidity and mortality, reduce the risks to health-care workers, and reduce immense stress on our health system.
“The search for preventive and curative solutions has presented a possible opportunity with the use of a well-established medicine listed on the WHO essential drug list. The latter is the anti-parasitic drug Ivermectin. It has changed the landscape of the scourge of parasite infections in many developing countries countries. The developers were recognised for their achievement by being awarded the Nobel Prize for Medicine in 2015.”
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.
Hill recently reported at an international Ivermectin conference a meta-analysis of data from the first 11 randomised controlled trials that have been identified which pointed to a “promise of Ivermectin as a low-cost, widely available therapy potentially useful in Covid-19".
They said his findings in the trials totalling 1,452 patients was that it was associated with faster time to viral clearance, shorter duration of hospitalisation, clinical recovery and survival rates.
“The IIG would like to remind the minister of health, the MAC [ministerial advisory committee] and all other leadership bodies that it has a public duty to protect the health of the citizens of this county and that it may not be remiss in doing so. It must act in the public interest, and the IIG is of the belief that it has a duty to properly and expediently explore the potential of medicines such as Ivermectin.”
The group is asking for the department and relevant bodies to consider a Sahpra section 21 application which considers unregistered veterinary or complementary medicine for human use within a strict protocol, as well as clinical-trial approval and implementation.
'Not unreasonable nor irrational' to consider Ivermectin
The second petition to the minister and other bodies from Shaik Emam was sent on Sunday.
Legal counsel acting on behalf of Shaik Emam wrote to Mkhize and the department of health to ask for an urgent meeting to discuss testing and possible rollout of the drug to the public.
In a letter to Mkhize, Semete-Makokotlela, Sahpra board chair Dr Helen Rees and lawyer Prabashni Subrayan Naidoo said while the government had spent R283m as part payment for the Covax vaccine which will be available to 10% of the population, it was not Sahpra-approved and there was no independent research or evidence to confirm that this vaccine will prevent further infections.
“It is common cause that SA is facing a health crisis as a result of the emergence of a mutated SARS-CoV-2 lineage. In the past 96 hours, SA has recorded a total of 67,438 new infections and 1,607 deaths,” they said.
“The minister of health in his briefing on the December 29 informed the South African public that while no research has been made to confirm the success of the Covax vaccine, SA relies on the evidence of international sources. It is on this basis that the government procured the Covax vaccine.”
They said Ivermectin has been in use internationally for more than 40 years and that Sahpra has neither confirmed nor denied that evidence exists that shows that the drug is effective in the treatment of SARS-CoV-2.
“In light of the honourable minister of health's contention that SA has to rely on international sources when considering whether a drug or vaccine is to be procured, it is not unreasonable nor irrational to expect the South African government to be consistent and consider the use of the Ivermectin drug.”
Subrayan Naidoo said Shaik Emam had made a number of attempts to meet the health minister and the department of health to discuss the use of Ivermectin to combat the transmission of the virus, without success.
“Our client is in possession of video evidence which shows that the drug Ivermectin is yielding positive results in combating SARS-CoV-2 and has had no side-effects on patients. Our client has reliably learnt that it will cost a total of R50m to manufacture the drug Ivermectin which will treat the population of SA.”
Video testimony of a US pulmonary and critical care specialist at Aurora St Luke’s Medical Centre in Milwaukee, Dr Pierre Kory, who described Ivermectin as a “wonder drug” with immensely powerful antiviral and anti-inflammatory agents before a Senate hearing last week, has gone viral internationally and locally prompting calls for the drug to be made available in SA.
Kory is president of the Front Line Covid-19 Critical Care Alliance, a working group of US medical experts who are dedicated to finding alternative proactive Covid-19 treatments.
Shaik Emam’s lawyer said in light of the information around the drug, he was seeking an urgent meeting to consider the testing in SA of the drug and if this was not effective, a written explanation detailing the reasons for this.
Subrayan Naidoo said if they didn’t receive a favourable response by close of business on Wednesday, they would turn to the high court for urgent relief.
Department remains sceptical
National health spokesperson Popo Maja told TimesLIVE that the minister has “noted” the letter from Shaik Emam's lawyer.
“The minister will have a meeting with the portfolio committee on health on Thursday January 7. Hopefully, the MP will raise the matter there,” he said.
Shaik Emam said he was forced to instruct an attorney because all attempts to raise the matter formally were unsuccessful.
“I was only informed very late of the possibility that the portfolio committee on health will be meeting. There will be many issues on the agenda, so who is to say that we will even discuss this matter, which is a matter of life and death,” he said.
Key findings of a department of health review document, dated December 21, 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 paper noted that while Ivermectin is not approved globally as an antiviral agent or registered in SA 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 December 21, 37 registered clinical trials investigating the drug had been completed but results were yet to be published.