The first look at a much-anticipated study of Gilead Sciences' remdesivir came not in a news release or a scientific journal, but in a White House briefing. The unorthodox data reveal was an effort to get ahead of leaks of fragmented information that could cause confusion, Anthony Fauci, M.D., director of the National Institutes of Health body that sponsored the study, told Reuters.
The data, from a placebo-controlled trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), showed that remdesivir shortened patients’ time to recovery by four days, or 31%. Fauci acknowledged during the White House briefing that the NIAID “would have normally waited several days” until the data were further analyzed to present them, but decided to release them so that patients taking placebo could be switched to remdesivir so that they might benefit.
“It was purely driven by ethical concerns,” Fauci told Reuters in a telephone interview.
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“I would love to wait to present it at a scientific meeting, but it’s just not in the cards when you have a situation where the ethical concern about getting the drug to people on placebo dominates the conversation,” he told Reuters.
Fauci pointed to the likelihood of partial results leaking from “dozens and dozens” of clinical trial sites.
“People were starting to leak it,” he told Reuters, but he did not say where data were being shared.
Unreported remdesivir data have already emerged this month, with the World Health Organization accidentally publishing an abstract online showing the treatment neither improved patients’ condition nor tamped down on the amount of virus in their blood. That followed the leak of early results from a Chicago hospital participating in one of Gilead’s studies suggesting the opposite conclusion, that remdesivir swiftly reduced fever and respiratory symptoms.