A quarrel has erupted over a World Health Organisation clinical trial which concluded that the anti-viral drug remdesivir has little or no impact on a patient’s chances of surviving COVID-19.
Gilead Sciences Inc, the US company that developed the drug, said the findings appeared inconsistent with evidence from other studies validating the clinical benefit of remdesivir, which was used to treat US President Donald Trump’s coronavirus infection.
“We are concerned the data from this open-label global trial has not undergone the rigorous review required to allow for constructive scientific discussion,” Gilead said.
“It is unclear if any conclusive findings can be drawn from the study results.”
But Richard Peto, an independent statistician hired by the WHO to scrutinise the results of its Solidarity trial, dismissed the criticism.
“It’s a reliable result, don’t let anybody tell you otherwise, because they’ll try to,” Mr Peto said.
“This is real world evidence.”
US President Donald Trump was given a course of the drug after testing positive for the coronavirus at the start of October.
The US was criticised in July after its health and human services department announced it had secured almost all stocks of the drug for the coming three months.
The WHO study involved more than 11,000 patients in 30 countries.
About 2,750 were randomly assigned to get remdesivir.
The rest were administered either the malaria drug hydroxychloroquine, the immune-system booster interferon, the antiviral combination of lopinavir and ritonavir, or just usual care.
The other drugs have largely been ruled out for COVID-19 by previous studies, but not remdesivir.
The results of the trial, announced by the WHO on Thursday, dealt a blow to one of the few drugs being used to treat people with COVID-19.
The UN health agency said remdesivir appeared to have little or no effect on keeping people alive or on the length of hospital stays among patients with the respiratory disease.
The results do not negate the previous ones, and the WHO study was not as rigorous as the earlier one led by the US National Institutes of Health.
The European Union just agreed to a €1 billion ($1.2 billion) deal for remdesivir.