Forchi said leak concerns revealed consequences of his White House Gilead drug

Chicago — Concerns about leaks forced US chief infectious disease data to reveal data on Gilead Sciences’ drug lemdesibir. It was first shown in scientifically rigorous clinical trials to be beneficial in the treatment of 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 placebos dominate the conversation, it’s not included on the card.”

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 investigators around the world,” Forch said. “People were beginning 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. In a statement Wednesday, NIAID said the long-awaited trial of NIAID met its main goal but didn’t 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 and everything of the study,” said Dr. Steven Nissen, senior researcher. Cleveland Clinic officer.

“I’m encouraged by what I hear? Yes, I’m encouraged. But I don’t want to fully understand what happened here and to know it through the photo opportunity from the Oval Office. . ”

Gilead’s data, published in its own study of lemdesibir, did not draw much attention because it did not 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,” Forti said in an interview.

“Like AZT, it’s the first baby step that comes in (lemdecibir) and is expected to be many better medicines that can treat people with COVID-19.”

(This story was organized to correct the spelling of “clinical” in paragraph 1)

(Reported by Julie Steenhuysen, edited by Michele Gershberg and Clarence Fernandez)