Fouch, Leak’s concerns fueled exposure of Gilead’s drug results in his White House

CHICAGO (Reuters) -Concerns about leaks lead US infections to be headed by Gilead Sciences Inc.GILD.O) The first in a scientifically rigorous clinical trial that showed benefit in the treatment of the drug lemdesibir, COVID-19.

Dr. Anthony Fauci’s dramatic presentation at the Oval Office on Wednesday raised concerns among scientists that the Trump administration is raising hopes for coronavirus treatment before sharing full data with researchers. Caused

As a warning example of increasing the potential value of therapy, he pointed out that President Donald Trump is repeatedly recommending the malaria drug hydroxychloroquine as a treatment, and there was no evidence of effectiveness.

New data suggest that malaria treatment may pose a significant risk to some patients with virally-induced respiratory disease.

Forchi, director of the National Institute of Allergy and Infectious Diseases (NIAID), who is conducting the trial, has the first opportunity to take patients who are taking dummy treatment or placebo should switch to lemdecivir to benefit. Then I announced that.

He expressed concern that a partial information leak would cause confusion. The White House hasn’t planned a virus briefing every day, so Forch said he was invited to release the news at a press conference with Louisiana Governor John Bell Edwards (D).

“It was driven by purely ethical concerns,” Forch told Reuters in a telephone interview.

“ I want to wait to announce it at a scientific conference, but in situations where ethical concerns about administering drugs to people at placebo dominate the conversation, it’s not included on the card. Hmm.”

The Independent Data Security Oversight Board, which was reviewing the preliminary results of the NIAID trial, determined that it met the primary goal of reducing hospitalization.

On Tuesday evening, the information was delivered in a conference call to scientists studying drugs worldwide.

“There are literally dozens of researchers around the world,” Forch said. “People were starting to leak it,” but did not reveal details of where unreported data was shared.

Several scientists interviewed by Reuters found that the White House setting was inadequate for publication of highly anticipated government-funded trial data on Gilead therapy.

They hoped it would be published at the same time in in-depth news releases, medical briefings, or scientific journals to allow researchers to review the data. Information from various trials of lemdecivir has been leaked to the media in recent weeks. Mr Gilead said in a statement Wednesday that the long-awaited trial of NIAID met major goals but did not provide details.

Data from another NIAID statement after Fauci published detailed preliminary results show that patients who received the drug had a 31% faster time to recovery and shorter hospital stays of 4 days than those who received placebo. It shows that.

The trial also came close to showing that drugs help people survive the disease, but the data just fell short of statistical significance.

“I want to see the complete data. I want to understand statistics. I want to understand the benefits and risks. I want to understand the structure of the study and all of it.” Dr. Steven Nissen, Chief Academy Officer at Cleveland Clinic, said. It was

“I’m encouraged by what I hear? Yes, I’m encouraged. But I want to fully understand what happened here, but the opportunity to take a photo from an oval office I don’t want to understand that through. ”Gilead’s data, published in its own trial of lemdesibir, didn’t draw much attention because it didn’t compare results between treated and untreated people.

The results of a third study in China suggesting that lemdecivir failed to help COVID-19 patients were published in the British medical journal The Lancet, after a review by a group of fellow scientists .

“It was the only thing I wore a hat and it was negative,” said Dr. Eric Topall, founder and founder of the Scripps Research Translational Institute in La Jolla, California. . He was not impressed with the modest benefits of remdesivir.

“It was expected to be a tremendous effect,” Topol added. “Obviously not.”

At a press conference at the Oval Office, Forch compared the study’s results with AZT, the first drug to show benefits for HIV decades ago. “We know that it was an incomplete drug. That was the first step,” Fochi said in an interview.

“Like AZT, this is (remdesivir), the first step expected to be the many better medicines that can treat and treat people with COVID-19.”