FDA ignores WHO advice and approves US Covid-19 drug
Gilead Sciences ignored WHO evidence that Remdesivir fails to reduce Covid-19 mortality in the US FDA submission for the drug’s approval.
The United States Food and Drug Administration decision last week to approve Gilead Science’s Remdesivir as a Covid-19 treatment failed to consider the results of the recent WHO “Solidarity Trial” – which found no measurable benefits for the drug’s use – because the pharmaceutical company failed to include the study in its FDA submission for approval, WHO’s Chief Scientist said on Friday.
Speaking at a WHO press conference, Soumya Swaminathan also said that she hoped to see results from “one or two” viable Covid-19 vaccine candidates emerging by the end of this year. But like other experts, she cautioned that even if all goes well, a vaccine would only likely become available in the first quarter of 2021 to the highest risk groups – like health workers.
“Certainly in early 2021, I think we’re going to start seeing more and more results coming out. And somewhere in the first quarter of 2021, we’re talking about the world, there may be some vaccines available for the most high-risk groups in countries around the world,” said Swaminathan, repeating a frequent WHO call that the initial, limited supplies should be fairly distributed with front-line health workers around the world getting access first.
Evidence that Remdesivir doesn't work omitted. In terms of Gilead's omission of the WHO evidence on Remdesivir, Swaminathan said that WHO provided the results of its Solidarity Trial, the largest of the drug in the world, to Gilead Pharmaceuticals on 28 September, even before they had been publicly announced on 16 October by WHO: “but it appears that the Solidarity results were not considered, were not provided to the FDA.”
She also said: “What we understand from the FDA decision yesterday was that it was based on data submitted to them from Gilead, which did not include the Solidarity Trial results.”
The WHO Solidarity trial is the largest in the world to have been conducted on the experimental treatment, which was originally developed for Ebola but never approved. The WHO Solidarity Trial of the drug's use against the SARS-CoV-2 virus that causes Covid-19 involved 5,000 patients around the world, who were randomised to administration of the drug or the standard of care.
Even though the WHO sponsored trial was not double-blinded – investigators knew which patients were being administered the drug or not, it was still “very robust” Swaminathan said, “because we looked at endpoints like mortality, like death, which is not a soft endpoint. It’s not something you can fudge. We looked at progression to ventilation, which is again, very objective, ”she said.
“We looked at very important endpoints, like hospital mortality. No difference. Progression to ventilation – 92% of the people who entered this trial were not on mechanical ventilation… We looked at how many of those progressed to need ventilation. There were exactly the same numbers in the Remdesivir and the control arm.”
The trial also looked at the proportion of patients discharged from hospital after seven days - and there again, there was “no difference in those proportions” for people receiving Remdesivir and receiving those a standard of care, she said.