Controversy Grows in Argentina After Its Use in Europe Rejected

The European Medicines Agency (EMA) concluded that the scientific data available to date does not support the use of ivermectin for the prevention or treatment of coronavirus outside of well-controlled clinical trials. The agency argues that more randomized studies are needed to determine whether the product is effective and safe.

The same guideline is followed by the National Food, Drug, and Medical Technology Administration (ANMAT), which also has not approved the administration of ivermectin to fight covid. Consider that the scientific evidence is not yet clear and studies conducted to date do not have a sufficient number of patients to demonstrate its clinical efficacy.

The same rhetoric supports the Argentine Society of Infectology (SADI) that as of October 10, 2020 and although there is no better quality evidence, it advises against the use of ivermectin for the treatment and / or prophylaxis of SARS-CoV2 (outside of studies well designed and properly registered that are ethically acceptable).

“The evidence for existence is very weak. We have to wait for more information. The use of a drug for compassionate use is only authorized for duly identified patients, which would exclude the massive administration of ivermectin as currently planned ”, explains Omar Sued, infectologist, president of SADI.

Ivermectin is a broad spectrum antiparasitic agent in human and veterinary medicine. In in vitro tests, it has shown its potential as an inhibitor of the SARS-CoV-2 virus. It became important when some clinical studies showed a significant reduction in the risk of infection and mortality of the positives.

Some Argentine provinces, such as Misiones, Salta, Jujuy, Corrientes, Tucumán and La Pampa, already use it as an official policy of prophylaxis among health workers and as a treatment for infected patients. While others are analyzing the situation and have shown interest in the drugs.

You in favor

“Given the negative impact of the pandemic and the urgency of the demand for effective treatment, the scientific information available on ivermectin should be sufficient for emergency approval. More than anything, knowing that apart from the vaccination there is no other tool of help available ”, underline the professionals of the Center of veterinary research Tandil (CIVETAN), without forgetting the data available to date are scarce.

On the other hand, one of the studies carried out by the Argentinian doctors Héctor Carvallo – academic coordinator of the general hospital of acute zone Eurnekian – and Roberto Hirsch – head of the service of the infectious diseases of the hospital of Muñiz – had concluded that Ivermectin is an effective method of treating healthcare workers and their contacts for SARS-CoV-2. In addition, they recommend implementing it in vulnerable population groups: geriatric and psychiatric institutes, orphanages and prisons, among others.

“This drug is not approved because it leaves no economic benefit to anyone nor can it exercise partisan discretion with it. provinces that implement it and they do it because they place the well-being of their inhabitants before any type of interest. Even many doctors and a large part of the population use it outside of Marketing Authorization (excluding Marketing Authorization), in almost the whole country. For our part. And published a multicenter study, which summarizes the positive experiences. I hope that the approval of ivermectin will arrive before the start of the second wave of the pandemic, ”Carvallo summarizes.

GS