Remdesivir Trial Missed a Huge Opportunity
The big Covid-19 news this week was a promising result from a new study of remdesivir, an anti-viral produced by Gilead Sciences. But lost in all the discussion of how well the drug works — an earlier study found it wasn’t helpful — was a tragic failure: Gilead missed its one shot at getting vital information on specifically which patients the drug could help.
The fact that a drug, any drug, seemed to fight Covid-19 is great news. But doctors also need information on whether older or younger patients were likely to benefit, for example, and how different pre-existing illnesses might tip the risk-benefit ratio. Instead, we got what Memorial Sloan-Kettering Cancer Center physician and epidemiologist Peter Bach calls the bare minimum of information — just enough to get the drug over the hurdles needed for approval. Now there are ethical barriers to the kinds of placebo-controlled studies needed to learn more.
There’s a tremendous heterogeneity in patients — in age, health conditions, symptoms, viral load and genetics. More studies of remdesivir would surely have saved lives by revealing whether remdesivir helps only a subset of patients, and whether it might even be toxic to others.
To recap: On Wednesday this week, the National Institute for Allergy and Infectious Diseases released results from a placebo-controlled trial of 800 patients, which showed those who got the real drug left the hospital earlier — after 11 days on average as opposed to 15. There was also a modest increase in survival which was not statistically significant.
This study comes after Gilead sponsored two other trials — a larger one for the severely ill, which involved 6,000 patients but didn’t use any control cases for comparison. Another, smaller study, for patients with moderate cases of Covid-19, hasn’t been released. That study used a control arm, but no placebo. That means doctors knew which patients got the drug, setting them up for potential bias.
There was also an earlier trial of the drug in Wuhan which found no benefit. But this study was discontinued early for lack of patients as the Chinese got their outbreak under control.
These earlier trials were not very informative, says Bach. But now that there has been some hint of promise from the NIAID trial, he says, it will become the standard of treatment and make it ethically difficult to do any more placebo-controlled studies.
With experts saying emergency-use authorization is imminent, Gilead is gearing up to make millions of doses. But the more ethical thing would have been to design the early trials to get as much insight as possible, says Bach. Now, in terms of data gathering, “We’re going to fall off a cliff.”
From a risk-management perspective, it’s optimal for the company’s bottom line, says Bach. Even if the still-unreleased study on moderate illness trial shows no effect, it will likely be trumped by the NIAID one.
Doctors are still on a steep learning curve and we’re only at the beginning of this pandemic. We should be trying as hard as we can to get as much insight as possible today. Rushing remdesivir through its early trials is a missed opportunity that might help some patients in the short term, but hurt many more over the months to come.
This column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.
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