It was the flagship drug against COVID-19. Now the World Health Organization advises against using the antiviral Remdesivir in coronavirus patients.
This is a new twist in the comings and goings of health authorities and pharmaceutical laboratories on possible treatments against the pandemic.
The WHO, in a statement issued a few hours ago, has advised against treatment with the drug developed against Ebola, from the US company Gilead because there is no evidence that it improves survival and other factors in patients. “The antiviral Remdesivir is not recommended for patients admitted to hospital for Covid-19, regardless of the severity of their illness, as there is currently no evidence that it improves survival or prevents them from being placed on artificial ventilation,” he says the notice.
They call, yes, to continue clinical trials to see if the drug works in specific categories of patients.
The news must have fallen like a jug of cold water in Europe. The European Medicines Agency approved it as the first valid treatment against COVID-19 and the European Commission hastened to sign an agreement to buy more than half a million doses in a contract that exceeds 63 million euros, in anticipation of possible supply problems.
The United States grabbed most of the world’s stocks when the first promising results were known, but the EU managed to gain a foothold.
Contacted by euronews, a spokesman for the European Commission explains that they “take note” of the change in the WHO’s point of view but that they are waiting for the complete data of the Solidarity study that has motivated it and other information to be communicated to them to see if the authorization for placing on the market needs to be updated. “At the moment, there are no changes to the authorized uses of Remdesivir,” says the spokesperson.
The Commission points out that they already knew that Remdesivir does not have too many effects on mortality, but that they were based on another study, the American NIAID-ACTT-1, which confirmed a reduction in convalescence time from 15 to 11 days for patients with moderate symptoms and 18 to 12 in patients in need of oxygen.
Thus, the benefits were considered to outweigh the risks taken.
The spokesperson tells us that, although the Commission has signed a framework acquisition contract with the manufacturer Veklury, these contracts do not oblige the member countries to buy, and each one can decide when to acquire them.
“As time is short – we are in a public health emergency situation – we have to invest not only in advance in the development of vaccines but also in access to therapies. Therefore, the Commission will continue to rely on the scientific knowledge of the EMA and it will guarantee that access to therapy, which can be beneficial in the treatment of patients with COVID-19, is available through the necessary instruments “, the spokesperson comments.
The European Medicines Agency (EMA) has responded to us along the same lines. They point out that the conditional authorization for placing on the market is an emergency measure that entails continuing to collect information on the drug. The organization’s committee on human medicines is studying, for example, recently received mortality data from day 28 and will do the same when WHO transmits the full results “to see if it is necessary to introduce any changes in the authorization of commercialization of Veklury in the EU. The EMA will communicate if it is necessary to make any changes in the current advice on the treatment “tells us a spokesman.
The Gilead laboratory regrets that the WHO does not take into account the good results of the NIAID-ACCTT-1 study. “We regret that the WHO recommendations do not take this data into account at a time when the number of new cases is increasing dramatically around the world and doctors are using Veklury, the first and only approved treatment for COVID-19 in more than 50 countries around the world, “Gilead reacted in a statement. The company made $ 900 million in the third quarter on this drug.
The ups and downs in treatment, a constant in the COVID-19 crisis
According to the US agency that regulates drugs, in an argument taken up by its European counterpart, Remdesivir is useful for reducing convalescence time in patients with moderate symptoms.
The person in charge of the NIAID-ACTT-1 study for Spain, Roger Paredes, from the Germans Trias i Pujol Hospital in Badalona, told us in June that Remdesivir reduced convalescence time by 30%. And he celebrated that it is the first drug that has been shown to be effective in real conditions and not just in the laboratory like hydroxychloroquine.
For the most serious patients, in intensive care, the European agency recommends the anti-inflammatory dexamethasone.
This is the latest treatment twist in a long series.
The most famous is hydroxychloroquine, which Donald Trump made famous, claiming to take it. However, when he was infected with COVID-19, Trump received neither chloroquine nor Remdesivir, but rather an experimental treatment based on antibodies.
The WHO first withdrew clinical trials with hydroxychloroquine, following a study published in the specialized medical journal The Lancet. When The Lancet decided to withdraw the article due to very serious flaws in its sources, the WHO reauthorized clinical trials with hydroxychloroquine, but the damage, in terms of confusion of public opinion, had already been done.
One of the great defenders of hydroxychloroquine, the French microbiologist Didier Raoult, denounces interests against this cheap and accessible drug, feeding conspiracy theories.
These ups and downs are normal among the scientific community but never before, for obvious reasons, have the public, the press and social networks been so attentive to each similar announcement.