How Trump’s COVID Chaos Drowned the FDA in Junk Science

Marks referred questions to the FDA press office, stating, “We decline to comment on internal discussions.”

The disaster at the White House press conference was bad enough. However, the announcement was widely seen as the prelude to a far more consistent announcement: the upcoming COVID-19 vaccine. Would the FDA surrender to President Trump and approve a vaccine before the presidential election, possibly before it was proven safe?

Hahn fought for his reputation and turned to one of his most passionate critics. Just after 6 a.m. on September 3, he coldly called Eric Topol, describing the pressures he was under, and admitting that he was facing an “existential crisis.” (Hahn denied with these words.)

About four months earlier, on April 29, Marks had gone to the White House to present his idea for the Trump administration’s only pandemic success: the breakneck development of a COVID-19 vaccine. Although Trump shifted responsibility for diagnostic tests and the lack of protective equipment to the states, with dire consequences, he embraced the efforts of the moon shot vaccine. As the drug companies went through clinical trials, it came down to the FDA making that profit.

A brilliant, if prickly, hematologist-oncologist, Marks had envisioned an extensive partnership between the federal government and private pharmaceutical companies to develop a number of vaccine candidates simultaneously. As a longtime Star Trek fan, he called the concept Operation Warp Speed. In the White House, Marks sat against the wall that early spring day as the best government health officials, including Hahn, huddled into a safe room until someone gave him her chair. While teaching the group, Deborah Birx aggressively questioned him and didn’t seem to understand that he was an FDA official outlining an idea and not an operations director unprepared to implement a plan.

When Hahn was silent Seema Verma, The Centers for Medicare & Medicaid Services administrator came up to Mark’s defense and said, “Deb, you’re out of line. Leave him alone. “Hahn, who still did not defend Marks with her, leaned over to Verma and said approvingly:” You are a really good egg. “

Even Azar interfered and asked Hahn: “Aren’t you going to stand up for your guy?” (Birx didn’t respond to a request for comment.)

Although Marks emerged from the meeting shaken, his idea was a success. Soon, Operation Warp Speed ​​began, an extensive – and mysterious – $ 15 billion program jointly conducted by the Departments of Defense, Health, and Human Services, whose management structure was aimed at achieving political, not just pharmaceutical, success. Jared Kushner and his pandemic wingman Adam Boehler were among the five members of a coordinating committee that oversaw the far-reaching efforts.

Even with Trump’s intent to get a vaccine approval before the elections, Hahn continued his trips to the White House, blinded like a “kid in a candy store,” said a senior HHS official.

At the time the FDA was considering a plan to tentatively approve a COVID vaccine for high-risk groups like nursing home residents before completing Phase III clinical trials, Vanity Fair learned. Taking a tiered approach, the FDA could weigh the risk against the benefit: a less-than-thoroughly-reviewed vaccine, but one that is more likely to protect the most vulnerable Americans. Then, as more data came in, the FDA could have expanded its approval to younger, healthier Americans. But the plan had a paradoxical liability: it could meet Trump’s desired schedule, thereby terrifying a public already skeptical of the FDA’s independence. (Although an FDA spokesperson denied that a “tiered” approach was ever considered, the agency had initially told drug companies that it could consider approval based on interim data, a source familiar with the discussions said .)

Coincidentally, the convalescent plasma disaster derails from such a plan. On August 31, in an open letter to Hahn in Medscape magazine, Topol named Hahn “subject to the whims of President Trump” and wrote, “Tell us… that under no circumstances will you give approval a SARS-CoV-2 vaccine approval prior to the full completion of phase 3 and the reading of a program. Otherwise you will have to resign. “

Meanwhile, the crisis within the FDA has widened. On September 10, the agency’s eight top career advocates who ran its science centers posted a statement in USA Today seeking to regain their independence and reaffirming that science was guiding their decisions. “If the agency’s credibility is lost due to real or perceived disruptions,” they wrote, “people will not rely on the agency’s security warnings.”

Although Hahn said the officers gave him a heads-up and received his blessing, the play was a “fuck-you” for the inspector, said a source familiar with its publication. The FDA was officially at war with itself.

Hahn had to stand aside. He eventually joined the agency’s career officials on a full review of a vaccine regardless of political implications. On September 21, the FDA sent new vaccine guidelines to the White House’s Bureau of Management and Household, asking drug developers to monitor patients participating in their clinical trials about two months after their last shot. It would push any vaccine approval beyond the November elections.

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