Despite a first Chinese study that advises against its use (and the doubts of the manufacturing company itself), the study center directed by the White House consultant virologist presents enthusiastic results on the drug, and approves its emergency use.
Dr. Anthony S. Fauci called a study on an experimental coronavirus drug (created for other purposes), Remdesivir, “very optimistic”. The FDA plans to announce the urgent use of the antivirus treatment that would show reduced recovery times from the disease.
Therefore, the FDA's announcement of an emergency use authorization for Remdesivir should arrive in these hours. Ahead of the announcement, President Trump and Dr. Anthony S. Fauci, the federal government's top scientist, met with reporters at the White House.
In the press conference, Dr. Fauci cautioned that the results of the study overseen by NIAD, the National Institute of Allergy and Infectious Diseases, have yet to be properly reviewed, but expressed optimism that it could make a difference.
In China, I have a different opinion
Among the first to experiment with the drug in the field (for obvious reasons) are the Chinese. I was talking about it here some time ago. Well, another study, conducted in China and published in the Lancet, has questioned the value of the drug for the treatment of seriously ill patients. Of course, it left open the possibility that it can be useful for others. However, the research on the latter is incomplete, due to the insufficiency of a congruous number of observers.
Fauci: “reduces recovery times by more than a third”
Dr. Fauci said Remdesivir could reduce recovery times by about a third. “Although a 31% improvement is not definitive, it is an important signal: because what it has shown is that a drug can block this virus,” Fauci said. “This is very encouraging.”
This is echoed by Trump, who called it a good sign. “It is certainly a positive event, it is a very positive event,” said the US President.
The producers themselves hold back
In a statement, Gilead Sciences claimed to be “aware of the positive data that has emerged” from Dr. Fauci's institute study. Very cautiously, then, the company adds: “We understand that the trial has reached its primary endpoint and that NIAID will provide detailed information at an upcoming briefing.” An acknowledgment that sounds rather lukewarm. And it is clear why: Remdesivir has not yet obtained a license or approval. Neither in the USA nor elsewhere in the world. “And it has not yet been shown to be safe or effective for the treatment of Covid-19,” they specify to Gilead itself.
The spokesperson, Ryan McKeel, said the company is unable to predict what actions the federal government will take. “However, we are continuing to discuss with them the growing body of evidence for remdesivir as a potential treatment for COVID-19, with the goal of making remdesivir more widely available to patients who urgently need treatment.” Meanwhile, after Fauci's announcement, Gilead stock soars on the stock market.
Remdesivir has never been approved as a treatment for any disease. It was developed to fight Ebola, but the results of a clinical trial in Africa were also disappointing.
Expectations have been fueled by anecdotal reports of Covid-19 patients taking Remdesivir and reportedly recovering. Two of these reports were published in the prestigious New England Journal of Medicine, giving credibility to what the researchers later claimed as uncertain results.
Without comparative studies between the drug and a placebo, it was impossible to know whether the drug made a difference or whether patients improved on their own with normal supportive care.
Remdesivir's study published in Lancet found no benefit for the drug over placebo .
“Unfortunately, our study found that, although safe and adequately tolerated, remdesivir did not provide significant benefits compared to placebo,” said the new study's lead investigator, Dr. Bin Cao of the China-Japan Friendship Hospital and the Capital Beijing Medical University. “This is not the result we were hoping for,” he added.
