As the coronavirus surged across the Sunbelt, President Donald Trump told a crowd gathered at the White House on July 4 that 99% of virus cases are "totally harmless."The next morning on CNN, the host Dana Bash asked Dr. Stephen Hahn, the commissioner of the Food and Drug Administration and
As the coronavirus surged across the Sunbelt, President Donald Trump told a crowd gathered at the White House on July 4 that 99% of virus cases are “totally harmless.”
Now seven months into his tenure, with the virus surging in parts of the country and schools debating whether to reopen, the push for a vaccine is intensifying. The government has committed more than $9 billion to vaccine makers to speed development, and last week Trump speculated that one could be ready by Election Day — a timeline that is unrealistic, according to scientists, and shows the strain Hahn may be under.
On the line as he spoke was Michael Caputo, a deputy to Hahn’s boss, Alex M. Azar II, the secretary of the Department of Health and Human Services. Since working for the consulting firm of the longtime Trump adviser Roger J. Stone Jr. in the 1980s, Caputo has been a cheerleader and even, once, a driver for the president.
But the FDA has never been pushed as hard as it is being pushed now, when it must vet every new treatment and vaccine for a disease that has already killed more than 160,000 Americans, under a president who downplays the severity of the pandemic and recommends unproven treatments. In a statement, Azar denied giving any such order. “There is not a shred of truth to this. In fact, I encouraged FDA to reach out to industry from the earliest days of the response,” he said. Asked whether someone else in the agency might have conveyed the message, Caitlin Oakley, a spokeswoman for Health and Human Services, said: “HHS has 80,000 employees and I can’t speak for all of them.”
In an effort to respond to public demand for more coronavirus tests, the agency then changed course, permitting scores of companies to sell tests that detect coronavirus antibodies, which show whether someone has been exposed to the virus in the past. Nine days later, the FDA issued an emergency authorization for the drugs in patients hospitalized with COVID-19.
“FDA is giving approvals right, left and center,” said Dr. Swapnil Hiremath, a nephrologist at the University of Ottawa and a critic of the blood filtration devices. “You need data.”
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