Dr. Anthony Fauci and top officials at the agency he heads scrambled in April 2020 to answer questions about altering the endpoint in a trial testing the antiviral drug called remdesivir, newly obtained emails show.
The endpoint was changed in the middle of the trial from measuring the effectiveness against death and various forms of hospitalization on day 15 to time to recovery through day 29.
Gilead Sciences, which makes the drug, announced the results of the trial in early April 29, 2020. Within hours, Fauci, the longtime head of the National Institute of Allergy and Infectious Diseases (NIAID), was trumpeting them to reporters at the White House.
The trial results proved that remdesivir “can block the virus” that causes COVID-19, said Fauci, who didn’t mention the change in endpoint.
Just hours later, doctors and reporters started questioning researchers involved with the trial and NIAID, which funded the study and said its officials were behind the change.
Officials at the agency were not prepared for questions about the matter, according to emails obtained by The Epoch Times and never published before.
Dr. Andre Kalil, an infectious disease expert at Nebraska Medicine Omaha who was helping run one of the trial sites, told Fauci, Dr. Clifford Lane, and John Beigel, all top NIAID officials, at 3:19 a.m. on April 30, 2020, that he had received multiple requests from colleagues and reporters on why the primary outcome was changed while the trial was underway.
“Believe or not, but I even heard nonsense things such as a conspiracy theory that Gilead opened the database and changed the primary outcome to favor the trial results,” Kalil wrote. “In order to prevent more conspiracies, I thought about a transparent and objective way to respond to these questions, so we can all be on the same page.”
The statement he proposed was redacted. NIAID, which released the emails based on a Freedom of Information Act request, cited an exemption that allows the government to shield inter-agency or intra-agency memorandums or letters “which would not be available by law to a party other than an agency in litigation with the agency.”
About two hours later, Lori Dodd, an NIAID statistician, responded by saying she liked what Kalil wrote. Soon after, Beigel, the trial’s principal investigator, said he was “merging the two” in an email that was otherwise redacted and on which Kalil had been cut out.
A draft statement was sent to the Food and Drug Administration, which “cleared with Gilead” a paragraph about the regulator’s “commitment to expediting” COVID-19 treatments and how the agency had been in touch with Gilead about making remdesivir available to patients “as quickly as possible, as appropriate,” the emails show.
The statement was still being adjusted at 3:20 p.m., according to a missive from Jennifer Routh, an NIAID spokeswoman, sent to Beigel, Lane, and others.
“We now have 10 media inquiries asking about why the primary endpoint in the remdesivir study changed,” she said, adding later: “We need a statement to respond as soon as possible. Is this OK to send or is this still under review?”
The draft statement was redacted.
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