Most scientists agree the National Institute of Allergy and Infectious Diseases, one of the 27 branches that make up the National Institutes of Health, faced a difficult decision when it decided to end a coronavirus treatment study early and begin giving remdesivir to patients assigned to receive a placebo after finding that the antiviral drug reduced recovery time. The call has received a lot of support, especially because it was made during a pandemic, and NIAID, considering it a moral imperative, has no regrets, Stat News reports. But there are some holdouts.
Steven Nissen, a trialist and cardiologist at the Cleveland Clinic, and Peter Bach, the director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, don't think recovery time reduction should have been the deciding factor. Instead, they say, the study should have continued until the NIAID was able to collect more data on mortality — the survival rate for coronavirus patients enrolled in the trial wasn't statistically significant when the study ended. "The question is: Was there a route, or is there a route, to determine if the drug can prevent death?," said Nissen.
Without getting a clearer answer to that question, he said, the study is a "lost opportunity."
The NIAID's clinical director, H. Clifford Lane, has a counter argument. He wants to know how "many patients would we want to put at risk of dying" to finalize a more complete study. Read more at Stat News.