This is not a cure
The results, which hit the headlines on Wednesday, came from a study sponsored by the National Institute of Allergy and Infectious Diseases, which Fauci is conducting.
The study of 1,063 patients found that those who received remdesivir had a 31 percent faster recovery than those who received a placebo – 11 days versus an average of 15 days. The results also suggest that patients given Remdesivir are less likely to die. However, the effect was so small that you would have to treat 28 patients with remdesivir to save a life, said Vincent Rajkumar, a doctor at the Mayo Clinic.
A leak of earlier data from the NIAID study earlier this month had suggested greater benefits to those taking remdesivir. However, the results released on Wednesday tempered expectations.
Public health experts have also been warning for months that finding a slam-dunk coronavirus drug won’t be the end of the pandemic. Rather, widespread testing and the development of an effective vaccine – which could be more than a year away – will curb the virus and curb hospitalization.
“This is not a magical cure,” said Jeffrey Gold, a doctor and chancellor at the University of Nebraska Medical Center, the lead researcher in the NIAID remdesivir study. But “if you combine that with more testing, contact tracking, and the ability to identify past patients … it all adds to a beam of light and looks us through.”
We still haven’t seen the actual data
One of the biggest scratches is the way the results of the NIAID study were released.
Gilead, who manufactures the drug, released a press release Wednesday morning saying that the NIAID study had reached its primary endpoint (although the company was not involved in the conduct of the study). A few hours later, Fauci shared some of the data with reporters during an appearance in the Oval Office. Later in the day, NIAID published a press release that repeated Fauci’s statements and added some additional details.
But no one outside of NIAID, Gilead, and the hospitals where the study was conducted saw the actual data. Some scientists and health experts wonder why there was no simultaneous data sharing besides the announcements.
“I understand the pressure, but if there is enough certainty to make it known to the nation, they should be able to publish a form detailing the methods and results,” said Harlan Krumholz, professor of medicine at the Yale School of Medicine. “Now we have heard results without being able to evaluate them. I hope that more complete information and current data will be available soon. “
Administration is complicated
Remdesivir is not a pill. Instead, it is an intravenous infusion that patients must take between five and ten days. According to Gilead, data released on Wednesday from his own study, which did not include a control arm, suggest that five days could be as effective as a longer dose. However, long-term dispensing of the drug still requires qualified doctors and nurses, IV care, and capacity in hospitals and clinics to treat patients.
These logistical hurdles make Remdesivir likely to be used first in critically ill and hospitalized patients, although the company has indicated that it may be more effective when given at the start of the infection. “Intravenous administration is likely to shift the treatment to serious hospital patients who, paradoxically, benefit the least from a drug that reduces the amount of virus in the blood,” wrote Brian Abrahams, analyst at RBC Capital, in March.
The bottom line, Rajkumar said, is that the effectiveness of the drug is limited by the difficulty in dispensing it.
It is not yet available for wide use
NIAID may have conducted the latest remdesivir study, but it is the Food and Drug Administration that decides when the drug will be launched.
There are a few options if regulators want to get the drug to people quickly. The FDA can grant emergency approval, as has been the case with several Covid-19 tests and the as yet undetected drug, hydroxychloroquine. This is under approval and may have restrictions on the use of medicines. “An EEA can be made as wide or narrow as the situation requires,” said Steven Grossman, president of the HPS Group policy advice.