Clinical trials of remdesivir, an antiviral drug that until recently was considered the most promising potential treatment for Covid-19, have been halted in the United States. This was announced by the National Institute of Allergy and Infectious Diseases (NIAID), which was conducting the trial.
It is interesting to note that the trials were not stopped because they failed – on the contrary. The experiment was stopped without waiting for the final results in order to avoid unnecessary casualties among the patients in the control group who were taking the placebo.
In practice, however, the decision means that the effectiveness of remdesivir in fighting the coronavirus, which has claimed nearly 300,000 lives, will have to be reassessed. The preliminary results of the experiment were announced two weeks ago, after two and a half months of testing. They seemed so promising to the organizers that the American authorities issued a special statement full of cautious optimism on the subject: Giving remdesivir to a patient in a hospital setting speeds up his discharge by almost one and a half times (11 and 15 days, respectively).
“The data show that remdesivir has a clear, significant, beneficial effect in accelerating recovery,” said NIH Director Anthony Fauci at the time. Just a few days later, the U.S. Food and Drug Administration approved the use of remdesivir for the treatment of Covid-19 on an emergency basis (i.e., prior to the required certification).
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However, evidence-based medicine recognizes only one method of testing the effectiveness of a drug – the double-blind, placebo-controlled method. In this method, participants are randomly divided into two groups: one group receives the new drug and the other receives its imitation, a placebo. It is not surprising that under pandemic conditions, the rigorous demands of evidence-based science often come into irreconcilable conflict with medical ethics.
If the experimental drug is somehow helpful in fighting the infection, then seriously ill patients who take a placebo instead (and don’t even know it) run the risk of dying just because they accidentally ended up in the control group. But if you give an experimental drug to all seriously ill patients without exception, then the terms of the trial are violated – and it becomes impossible to determine the effectiveness of the drug. In this paradoxical way, the announcement of the interim results of the remdesivir trials put an end to the entire experiment. As soon as it became clear that the drug might be effective, it was immediately given to all the patients, eliminating the control group – and the study lost its purpose.
“How many patient lives are we willing to risk to get the missing data?” – NIAID Clinical Director Clifford Lane asks rhetorically. “You can probably have some discussions about this (everyone tries to play the devil’s advocate in such a situation), but there was no disagreement at our institute about what action to take,” he asserts.
Not everyone initially shared Fauci’s optimism about the experimental therapy. Even the interim data from the drug trials look quite contradictory. For example, Forbes magazine points out that when testing an antiviral drug, it makes sense to first look at the patient’s viral load. That is, whether the concentration of the pathogen in the blood changes. For some reason, however, the authors of the study did not mention this indicator at all when they announced the interim results. And here, the authors of a similar experiment conducted a little earlier in China found that remdesivir had no effect on the viral load of Covid-19 patients. Not surprisingly, this study comes to the opposite conclusion: the drug is useless in the fight against the new coronavirus.
There are other reasons why many experts are disappointed with the NIAID’s decision to end the trial early. Especially since it involved four times as many patients as the Chinese study. “The global lockdown was not imposed to reduce the number of days infected people spent in the hospital. It was to reduce the number of deaths,” said Peter Bach, director of the Center for Health Policy in New York. “And until we understood whether the drugs were affecting the mortality rate, we could not stop.”