Timothy L. O’Brien: Trump’s vaccine rush redefines ‘regulatory capture’

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We are still mired in a pandemic. A new record for daily cases globally — 307,930 — was set on Sunday. At least 196,000 Americans have died from COVID-19, and winter is coming. Yet the guidance from leading federal officials overseeing the push for a vaccine continues to be dangerously inconsistent.

On Wednesday, Paul Mango, the deputy chief of staff for policy at the Department of Health and Human Services, told Bloomberg News that the Food and Drug Administration will “approve shots before the end of the year.” That timetable, he said, along with existing contracts with pharmaceutical companies to deliver adequate supplies, means that the government can “vaccinate every American before the end of first-quarter 2021.”


Robert Redfield, the director of the Centers for Disease Control and Prevention, told the Senate Wednesday that a COVID-19 vaccine won’t be available to the public until late next spring or summer. Redfield also shared his misgivings about HHS’s former chief spokesman, Michael Caputo. He told senators he was “deeply saddened” that Caputo would say government scientists wrangling with COVID-19 were actually running a “resistance unit” against President Donald Trump.

“CDC is made up of thousands of dedicated men and women, highly competent,” Redfield said. “It is the premier public health agency in the world.”

Redfield’s agency has fumbled mightily during the pandemic, so he shouldn’t assume the public still holds it in such high regard. But his point is valid: The efforts of well-trained and skillful public servants at the CDC to provide clear, reliable information about the pandemic are undermined by political hackery a la Caputo.

Caputo was just an underling, however. The real problem is Trump himself. Although officials overseeing the White House’s vaccination push, Operation Warp Speed, have told me and others that they don’t anticipate a viable vaccine until January or so, Trump has been touting the arrival of a miracle cure by Election Day. He said so during the Republican National Convention, and he’s kept at it since.

On Tuesday evening, Trump told an ABC News town hall that a vaccine could arrive within a month. “The previous administration would have taken perhaps years to have a vaccine, because of the FDA and all the approvals,” he allowed. “We’re within weeks of getting it. You know, could be three weeks, four weeks.”

Just hours after Redfield’s testimony on Wednesday, Trump convened a White House press briefing. When a reporter pointed out that Redfield told the Senate a “vaccine for the general public likely would not be available until probably next summer, maybe even early fall,” Trump would have none of it.

“I think he made a mistake when he said that. It’s just incorrect information. And I called him, and he didn’t tell me that, and I think he got the message maybe confused,” Trump, the reality TV star, said of Redfield, the professional virologist. “No, we’re ready to go immediately as the vaccine is announced, and it could be announced in October. It could be announced a little bit after October.”

Once upon a time, the term “regulatory capture” referred to the problems and dangers that arise when an industry exercises so much influence over its government regulator that essential rules are ignored. In the COVID-19 era, we have a new definition: regulatory agencies so acquiescent and beholden to the White House’s political agenda that the president himself undermines their work.

That the date for a COVID-19 vaccine debut has become a ping-pong ball is bad enough. But some federal officials have amplified the problem. Consider Stephen Hahn, who runs the FDA.

A career cancer doctor before he took the reins last December, Hahn has repeatedly sabotaged his own credibility by catering to Trump’s timelines, whims and bonkers explanations about how to contend with the pandemic. Although Trump has tweeted his belief that the FDA is part of a “deep state” cabal aligned against him, Hahn hasn’t aggressively defended the agency’s reputation or independence.

Over the summer, Hahn allowed the FDA to grant an emergency use authorization for a controversial drug, hydroxychloroquine, that Trump had promoted as a coronavirus treatment — only to revoke the authorization in July as evidence against the drug’s safety and effectiveness continued to mount.

“I think we can all agree that the issue of hydroxychloroquine has become politicized,” said Hahn, who helped politicize it. “And it’s a shame because … public health emergencies shouldn’t be about politics.”

That’s true. Emergencies shouldn’t be about politics. Yet last month, Hahn stood next to Trump during a White House briefing and extolled the medical benefits of using blood plasma from recovered COVID-19 patients — saying incorrectly that plasma could save 35 in 100 COVID-19 patients. He was forced to apologize via Twitter the next evening, noting that criticism about his plasma claims was “entirely justified” and that the public should be reassured that decisions at the FDA “will remain data-driven.”

Will they? Bill Gates isn’t sure. The Microsoft founder and philanthropist, who has dedicated a large portion of his fortune and time to public health issues, told Bloomberg News this week that he thinks the FDA has “lost a lot of credibility.” The White House recently installed a Caputo-like spokeswoman at the FDA, Emily Miller, who was reassigned after just 11 days on the job in the wake of the blood plasma imbroglio. And the White House shows no sign it’s willing to let federal agencies running the pandemic response speak candidly to the public about the data, as this important Politico piece details. Before taking a leave of absence from HHS on Wednesday, Caputo reportedly had been attempting to meddle with weekly CDC reports on the coronavirus and other health issues.

If and when a safe and effective vaccine is ready, an already skeptical public will decide whether it trusts in the government’s professionalism, competence and honesty enough to accept it. Until then, the folks who work at federal agencies steering the effort — at least those who aren’t Trump operatives — will have to push back against the White House and look out for their fellow Americans.



Timothy L. O’Brien is a senior columnist for Bloomberg Opinion.


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