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Drug delay dismay

THERE is growing discord between medical practitioners and the Ministry of Health and Wellness (MOHW) regarding a near two-month delay in approving the procurement of the drug Ivermectin, which some doctors want incorporated into the island’s COVID-19 management protocols.

A medical source close to the Jamaica Observer disclosed that the snail-paced movement of the MOHW regarding procurement and distribuion of the drug has concerned several doctors and led to the Medical Association of Jamaica (MAJ) issuing a press release last Thursday urging that approval for the importation of the drug be given for use on prescription, at the discretion of qualified physicians, for prevention and treatment of the disease.

According to MAJ President Dr Andrew Manning, Ivermectin has been safely used for decades in the effective treatment of certain parasites in humans.

“Potent anti-inflammatory and anti-viral properties have now been demonstrated against SARS CoV-2. A significant body of peer-reviewed evidence has now emerged pointing to the fact that Ivermectin may decrease the case count and mortality rates when used as a prophylactic agent, and when used in the treatment of all stages of COVID-19. The safety profile of this drug is well demonstrated after 40 years of clinical use,” the MAJ president said.

On Friday, the Private Sector Organisation of Jamaica joined the MAJ in its call for the approval of importation of the drug, saying all interventions that can be employed to save the lives of Jamaicans must be urgently evaluated and implemented.

In an interview, general surgeon Dr Charles Royes told the Sunday Observer that he has been following the developing story of Ivermectin for several months.

He said that on December 29 he submitted a letter, and other relevant documentation to the MOHW. Subsequently, he was asked to participate in discussions with a MOHW advisory panel and, as far as he knew, the panel reported favourably on the importation of Ivermectin.

Dr Royes emphasised that the push for Ivermectin is not as a substitute for vaccination, but rather the availability of a drug that can complement vaccination efforts.

“Between now and the time when we achieve vaccine adequacy in Jamaica — and it could be several months before we have an adequate number of people vaccinated — people are getting sick and, unfortunately, some are dying. This could be significantly reduced, the number of people in hospital could be significantly reduced,” Dr Royes said.

He added that attempts have been made to ask the MOHW to allow the importation of Ivermectin — a drug, which is known to be safe and purported to be very effective — but not much has been done

“Bring it in by the privates distributors and allow our pharmacies to be stocked so it can be used at doctors’ discretion on their prescription. There are doctors with adequate evidence of its efficacy. It doesn’t have to be used under the aegis of the ministry, it doesn’t have to be declared to be the ministry’s plan. Allow it to come in; it’s not harmful and it seems to be effective,” he said.

According to Dr Royes, the drug, which is produced in both a human and an animal formulation, has been in use for more than 40 years, mainly as an anti-parasitic. He explained that the human product made a “tremendous impact” in some tropical countries years ago, particularly on the African continent, in helping to effectively control two particular illnesses — river blindness and filiariasis. Tens of millions of people continue to use it in several countries.

Further, he said that early in the COVID-19 outbreak it was observed that in areas of the world where people use Ivermectin as an anti-parasitic there was a relatively reduced prevalence of COVID-19.

Initial laboratory (in vitro) studies out of Australia using high doses were followed by a lot of clinical work using doses appropriate for clinical use and the results consistently came back positive in both prevention and treatment of the disease. Much of the early data came from countries like Bangladesh and Egypt, and in South America, but seemed to attract little attention.

Eventually, prominent pulmonologists Pierre Kory and Paul Marik in the United States published their experience under the Front Line COVID-19 Critical Care Alliance and presented a report to the US Senate Committee on Homeland Security and Governmental Affairs on December 8, 2020.

Subsequently, Dr Andrew Hill from University of Liverpool published a meta-analysis of studies to date, which indicated that the drug was both safe and offered effective prevention and treatment of COVID-19.

Last month, Dr Tess Lawrie, principal director of Evidence Based Medical Consultancy Limited, and an advisor to the World Health Organization (WHO), published her own meta-analysis and concluded that “the drug should be globally and systematically employed in the prevention and treatment of COVID”. Using standard statistical methods, Dr Lawrie reports that Ivermectin could provide a 90 per cent reduction in contracting the infection in those exposed, and an overall 83 per cent reduction in the death rate.

“Those I hear raising objections are not challenging the findings we have in front of us. Instead, the objection is that the WHO and PAHO (Pan-American Health Organization) have not yet approved the drug for treatment of COVID. A recent WHO report is that it is under consideration. Meanwhile, the US National Institutes of Health, in light of the recent meta-analyses, has upgraded its stance on Ivermectin from ‘against’ to ‘neither for nor against’ — which essentially gives the green light to use under medical discretion,” Dr Royes said.

“In the light of the evidence, I don’t think we would be crossing any lines if we simply allow the drug to come into the island — that’s all. Allow doctors to use it a their discretion on prescription for their patients. Why should we be denied that?” he reasoned.

“The line of argument is that we are grabbing at straws. Perhaps this is understandable as a number of treatments previously recommended have failed to provide the hoped-for outcomes. The fact that we have been disappointed in the past doesn’t mean that we mustn’t keep trying. Should Ivermectin prove to be less effective than expected we wouldn’t be embarrassed. What we would say is that on very good grounds we made every effort we could to stem this tide, rather than standing on the sidelines and saying we don’t know about it, so we’re not going to use it,” Dr Royes argued.

However, despite expressed opinion and advice from the medical community, the MOHW officials appear tight-lipped on the issue.

When contacted by the Sunday Observer for a response, Chief Medical Officer Dr Jacquiline Bisasor McKenzie, without listening to the nature of the newspaper’s call, said she was in a meeting and could not concentrate on what the reporter was about to ask. She directed queries to director of communications in the MOHW, Stephen Davidson.

A response was not provided.

In addition, Health and Wellness Minister Dr Christopher Tufton said the expert group at MOHW were looking at the studies and will make a recommendation soon.

Meanwhile, senior plastic surgeon Dr Guyan Arscott said he vehemently disagrees with the MAJs recommendation “at this crucial time”.

“We must concentrate on vaccination. Instead, the MAJ have taken a position without solid, scientific evidence. They are expected to be the voice of reason for the people of Jamaica on medical matters. I cannot support them on the Ivermectin controversy. I don’t think they speak for the majority of doctors,” Dr Arscott said.

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