The pharmaceutical company Gilead have released additional data about the drug remdesivir for the treatment of COVID-19, including data on deaths.
Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene and Tropical Medicine, said:
“Gilead Sciences have done a number of good things in this pandemic, but their approach to obtaining proper randomised trial evidence for the efficacy, especially in terms of mortality, of remdesivir have been below the standards I would expect of a large ethical pharmaceutical company. Their first approach was to only sponsor trials where both arms received remdesivir and they have relied on other sponsors to carry out the higher standard of trial to evaluate remdesivir.
“They have consistently released information via press releases rather than awaiting at least a pre-print publication of the trial report. This announcement is not enormously useful at the level of treating patients because the amount of additional randomised evidence is small, especially when it is possible that the global availability of the drug could be restricted. The strong randomised evidence does suggest that remdesivir will reduce mortality, but there is a danger of this being exaggerated, especially when the only information is in a press release. According non-randomised data a similar level of reliability is not warranted.”
Prof Martin Landray, Professor of Medicine & Epidemiology, Nuffield Department of Population Health, University of Oxford, said:
“What has been reported today is an association – the results of comparing two rather different groups of patients. It is impossible to draw any conclusions about the true effects of remdesivir on survival. For that we need robust evidence from suitably large randomized controlled trials – and we simply don’t have that yet.”
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Prof Stephen Evans: “No conflicts of interest. I am funded (1 day/week) by LSHTM. They get funding from various companies, including Astra Zeneca and GSK but I am not funded by them, I have no involvement in obtaining funding from them and I am not an investigator or any grants obtained from them. I am the statistician to the “meta-Data Safety and Monitoring Board” for CEPI [https://cepi.net/]. I will probably be paid for my attendance at meetings and expenses for travel.”
Prof Martin Landray: “Co-chief investigator of the RECOVERY trial of potential treatments for COVID-19 (funded by UKRI and NIHR).
Research funding to University of Oxford received from Novartis, Boehringer Ingelheim, and Merck Sharp & Dohme.
Infrastructure and core funding received from Health Data Research UK, NIHR Oxford Biomedical Research Centre, UK Biobank Ltd, MRC Population Health Research Unit, and British Heart Foundation Centre for Research Excellence.
Employee of University of Oxford with salary supported by Li Ka Shing Foundation, Health Data Research UK, NIHR Oxford Biomedical Research Centre, Wellcome Trust, and National Health Service.”