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 The dramatic announcement by Dr Anthony Fauci in the Oval Office on
Wednesday prompted concerns among scientists that the Trump
administration was raising hopes about a coronavirus treatment
before sharing the full data with researchers.
As a cautionary example of inflating the potential value of a
therapy, some pointed to President Donald Trump’s repeated
endorsements of malaria drug hydroxychloroquine as a treatment, with
no evidence that it works.
Newer data suggests the malaria treatments may carry significant
risks for some sufferers of the respiratory disease caused by the
virus.
Fauci, director of the National Institute of Allergy and Infectious
Diseases (NIAID), which is running the trial, said he took the first
opportunity to get the word out that patients taking a dummy
treatment or placebo should be switched to remdesivir in hopes of
benefiting from it.
He expressed concern that leaks of partial information would lead to
confusion. Since the White House was not planning a daily virus
briefing, Fauci said he was invited to release the news at a news
conference with Louisiana Gov. John Bel Edwards(D). "It was purely
driven by ethical concerns," Fauci told Reuters in a telephone
interview.
"I would love to wait to present it at a scientific meeting, but
it's just not in the cards when you have a situation where the
ethical concern about getting the drug to people on placebo
dominates the conversation."
An independent data safety and monitoring board, which had looked at
the preliminary results of the NIAID trial, determined it had met
its primary goal of reducing hospital stays.
On Tuesday evening, that information was conveyed in a conference
call to scientists studying the drug globally.
"There are literally dozens and dozens of investigators around the
world," Fauci said. "People were starting to leak it." But he did
not give details of where the unreported data was being shared.
Several scientists interviewed by Reuters felt the White House
setting seemed inappropriate for the release of highly anticipated
government-funded trial data on the Gilead therapy.
They had expected it to be presented simultaneously in a detailed
news release, a briefing at a medical meeting or in a scientific
journal, allowing researchers to review the data.
Information from various trials of remdesivir has been leaked to
media in recent weeks. In a statement on Wednesday, Gilead said the
NIAID's much anticipated trial had met its primary goal, but gave no
details.
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Data in a separate NIAID statement after Fauci spoke detailed preliminary
results showing that patients who got the drug had a 31 percent faster time to
recovery than those who got a placebo, cutting hospital stays by four days.
The trial also came close to showing the drug helped people survive the disease,
but the data fell just short of statistical significance.
"I want to see the full data. I want to understand the statistics. I want to
understand the benefit and risk. I want to understand the structure of the
study, and all of it," said Dr. Steven Nissen, the chief academic officer at the
Cleveland Clinic.
"Am I encouraged from what I've heard? Yes, I'm encouraged. But I want to get a
full understanding of what happened here, and not get it via a photo opportunity
from the Oval Office."
Data Gilead released on its own trial of remdesivir drew less attention, as it
did not compare outcomes between those receiving therapy and those who did not.
Results from a third study in China suggesting remdesivir failed to help
COVID-19 patients were released in the British medical journal the Lancet after
review by a peer group of scientists.
"That's the only thing I'll hang my hat on, and that was negative," said Dr.
Eric Topol, director and founder of the Scripps Research Translational Institute
in La Jolla, California.
He was unimpressed by remdesivir’s modest benefit.
"It was expected to be a whopping effect," Topol added. "It clearly does not
have that."
At the Oval Office news conference, Fauci compared the study findings to AZT,
the first drug to show any benefit against HIV, decades ago.
"We know that was an imperfect drug. It was the first step," Fauci said in the
interview.
"Similar to AZT, it's (remdesivir) the first baby step towards what hopefully
will be a number of better drugs that will come in and be able to treat people
with COVID-19."
(This story has been refiled to correct spelling of "clinical" in paragraph one)
(Reporting by Julie Steenhuysen; Editing by Michele Gershberg and Clarence
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