Trump pressures FDA, claiming ‘deep state’ slowing COVID-19 vaccine

For most of President Donald Trump’s administration, science-driven health agencies have faced less of the criticism and mistrust aimed at the spy agencies, the Justice Department and other parts of the federal government.

But with Trump’s political future hinging on his response to the COVID-19 pandemic and his promise to bring forth a vaccine by Election Day on Nov. 3, the U.S. Food and Drug Administration is now facing the same sort of political pressure and rhetoric from the White House as those other parts of government.

On Saturday, Trump suggested that employees at the FDA are attempting to sabotage his reelection by slowing down coronavirus research.

In a tweet, Trump said members of “the deep state” at the FDA are making it hard for drug companies to “get people in order to test the vaccines and therapeutics” and “obviously” want to delay progress until after Nov. 3, Election Day. He tagged FDA Commissioner Stephen Hahn, appointed by Trump in 2019, in the tweet.

There’s no evidence that the scientists and staff of the FDA are delaying treatments or vaccines that would likely prevent tens of thousands of deaths in the U.S. and across the world in service of a secret anti-Trump agenda.

The “deep state” is a term used by Trump to describe employees of government agencies that he believes are manipulating policy to work against his interests.

But Trump’s comments Saturday, at a time U.S. deaths attributed to the coronavirus have passed 175,000, follow a gradual buildup of criticism aimed at the agency over the course of the pandemic.

Earlier this week, Trump suggested that health and science officials inside the administration were delaying an emergency measure to expand access to blood plasma from COVID-19 survivors as a treatment.

And for months, Trump has touted what he claims are the benefits of the malaria drug hydroxychloroquine — including criticism of the FDA after the agency revoked a measure encouraging the drug’s use.

The FDA didn’t immediately respond to a request for comment on Trump’s remarks.

House Speaker Nancy Pelosi, the California Democrat, in remarks on Saturday said Saturday’s tweet “was a very dangerous statement on the part of the president.” The comments could also undermine trust that a vaccine will work and is safe, if it’s rushed to the public under political pressure. An Aug. 7 Gallup poll found that one-third of people would not get a COVID-19 vaccine when it’s ready, even if it was free.

An effective vaccine is considered pivotal to ending the pandemic. It would provide protection from the virus to healthy people, allowing them to go back to work, go to restaurants, return to school and resume most aspects of normal life. To speed development, the White House has launched Operation Warp Speed, signing agreements with drugmakers worth more than $4 billion.

The industry has embarked on what’s likely the most ambitious research and development effort in its history. The biggest drugmakers in the world, as well as a number of innovative biotechnology companies, have developed vaccine candidates in record time and are putting them into human trials. Thirty vaccines are now in human testing, according to a Thursday summary by the World Health Organization.

The FDA, too, has been moving far faster than normal. The agency has tentatively scheduled an Oct. 22 meeting to consider a potential vaccine, and health officials across government are working on guidelines for who would first get any vaccine and how it would be distributed.

Any shot would likely be used first in a narrow group of high-risk people, like health workers, before being rolled out to the public in phases next year. But that timeline is still a fraction of the years it typically takes to develop, test and review a new inoculation.

The FDA’s Hahn has, in public, walked a line of deference to Trump while occasionally pushing back against some of the president’s claims. After Trump suggested in April that chemical disinfectant could be used to clean the virus from people, Hahn said that Americans shouldn’t ingest or inject bleach. But he’s declined to remark on some comments Trump has made, such as saying in July that 99% of all COVID-19 cases are “totally harmless.”

“I’m not going to get into who is right and who is wrong,” Hahn said in an interview the next day.

One of the leading vaccines is being developed by New York’s Pfizer Inc. The company’s trial has been enrolling patients rapidly, with more than 9,000 volunteers as of Wednesday, according to Philip Dormitzer, Pfizer’s vice president of viral vaccine research.

“Things are going very quickly,” Dormitzer said earlier this month. “We remain on target” to have results ready to submit to regulators in October. Another vaccine, being developed by Moderna Inc., has enrolled about 13,000 people in its 30,000-person trail. The company is “on track” to complete enrollment in September, said Moderna spokeswoman Colleen Hussey.

“We have no comment on the tweet,” said Hussey. Pfizer didn’t immediately respond to a request for comment.

Saturday’s Twitter message from Trump was the latest in a growing drumbeat from the president aimed at his health agencies.

Earlier this week, Trump suggested the delay in an emergency measure supporting blood plasma was a political one.

“I hear great things about it, that’s all I can tell you,” Trump said at a White House news conference Wednesday, talking about blood plasma. “It could be a political decision because you have a lot of people over there that don’t want to rush things because they want to do it after November 3rd.”

And while the medical community has, in general, lost interest in hydroxychloroquine as a treatment for the virus after repeated trials failed to show that it works, Trump’s reiterated his support for it again on Saturday.

Reacting to the FDA’s months-old decision in June to revoke its emergency backing of the drug, Trump tweeted that “Many doctors and studies disagree with this!”

While Trump’s tweets are likely the most public recent efforts by a president to influence the FDA, the agency has never been immune from political pressure.

“One of Commissioner’s jobs is to protect this critical independence of judgement of the Center Directors and their staffs. It is naive to believe that politics aren’t part of the picture — both Dems and Reps,” former FDA Commissioner Robert Califf said in a tweet on Saturday. Califf served in the Obama administration in 2016 and 2017.

In 2011, for example, the Obama administration’s top health official overruled the agency, and said that the “morning after” birth control pill should be available to teens without a prescription.

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With assistance by Erik Wasson.