For much of President Donald Trump’s administration, science-driven health agencies have faced less criticism and distrust of spy agencies, the Department of Justice, and others. parts of the federal government.
But with Trump’s political future depending on his response to the Covid-19 pandemic and his promise to produce a vaccine by election day on November 3, the United States Food and Drug Administration is now facing the same kind of political pressure and rhetoric from the White House as these other parts of government.
On Saturday, Trump suggested that FDA employees try to sabotage his re-election by slowing coronavirus research.
In a tweet, Trump said members of the FDA’s “deep state” made it difficult for drug companies “to get people to test vaccines and therapeutics” and “obviously” wanted to delay progress until ‘to November 3. Election day. He tagged 2019 Trump-appointed FDA commissioner Stephen Hahn in the tweet.
There is no evidence that scientists and FDA staff are delaying treatments or vaccines that would likely prevent tens of thousands of deaths in the United States and around the world in the service of a secret anti-Trump agenda.
The “deep state” is a term used by Trump to describe the employees of government agencies who he says manipulate politics to go against his interests.
But Trump’s comments on Saturday, as U.S. deaths attributed to the coronavirus surpassed 175,000, follow a gradual rise in criticism of the agency during the pandemic.
Earlier this week, Trump suggested that health and science officials within the administration were delaying an emergency measure to expand access to blood plasma for Covid-19 survivors as treatment.
And for months, Trump has touted what he claims to be the benefits of the malaria drug hydroxychloroquine, including criticism from the FDA after the agency revoked a measure encouraging use of the drug.
The FDA did not immediately respond to a request for comment on Trump’s remarks.
House Speaker Nancy Pelosi, Democrat of California, said in an address Saturday that Saturday’s tweet “was a very dangerous statement by the president.” The comments could also undermine confidence that a vaccine will work and be safe, if rushed to the public under political pressure. An August 7 Gallup poll found that a third of people would not receive a Covid-19 vaccine when it was ready, even if it was free.
An effective vaccine is considered essential to end the pandemic. This would provide protection against the virus for healthy people, allowing them to return to work, eat out, return to school and resume most aspects of normal life. To accelerate development, the White House launched Operation Warp Speed, signing deals with drugmakers worth more than $ 4 billion.
The industry has embarked on what is arguably the most ambitious research and development effort in its history. The world’s largest drug makers, along with a number of innovative biotechnology companies, have been developing vaccine candidates in record time and are putting them to human trials. Thirty vaccines are currently being tested in humans, according to an Aug. 20summary from the World Health Organization.
The FDA has also progressed much faster than normal. The agency tentatively scheduled a meeting on October 22 to review a potential vaccine, and health officials across government are working on guidelines for who would get a vaccine first and how it would be distributed.
Any vaccine will likely be used first in a small group of high-risk people, such as health workers, before being released to the public in stages next year. But that timeline is still only a fraction of the years it typically takes to develop, test, and examine a new inoculation.Hahn of the FDA has, in public, shown deference to Trump while sometimes rebuffing some of the president’s claims. After Trumpsuggested in April that the chemical disinfectant could be used to clean the virus from people, Hahn said Americans should not ingest or inject bleach. But he declined to comment on some comments Trump made, for example saying in July that 99% of all Covid-19 cases are “completely harmless.”
“I’m not going to get into who’s right and who’s wrong,” Hahn said in an interview the next day.
Drug Manufacturer Trials
One of the main vaccines is developed by New YorkPfizer Inc. The company’s trial recruited patients quickly, with more than 9,000 volunteers as of Aug. 19, according to Philip Dormitzer, Pfizer’s vice president for viral vaccine research.
“Things are moving really fast,” Dormitzer said earlier this month. “We remain on target” to have results ready to be submitted to regulators in October. Another vaccine, developed byModerna Inc., has enrolled approximately 13,000 people in its 30,000-person course. The company is “on track” to complete listing in September, Moderna spokesperson Colleen Hussey said.
“We have no comment on the tweet,” Hussey said. Pfizer did not immediately respond to a request for comment.
Trump’s Saturday Twitter post was the latest in a growing drumbeat from the president to his health agencies.
Earlier this week, Trumpsuggested the delay in an emergency measure supporting blood plasma was political.
“I hear great things about it, that’s all I can tell you,” Trump said at a White House press conference Wednesday, speaking of blood plasma. “It could be a political decision because there are a lot of people out there who don’t want to rush things because they want to do it after November 3.
And while the medical community has, in general, lost interest in hydroxychloroquine as a treatment for the virus after repeated trials failed to show it works, Trump reiterated his support on Saturday.
Reacting to the FDA’s decision months ago in June to revoke emergency support for the drug, Trump tweeted that “a lot of doctors and studies disagree with this!”
While Trump’s tweets are probably the most recent public efforts by a president to influence the FDA, the agency has never been immune from political pressure.
“One of the tasks of the commissioner is to protect this critical independence of judgment of center directors and their staff. It is naive to believe that politics is not 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 senior health official in the Obama administration dismissed the agency and said the “morning after” birth control pill should be available to teens without a prescription.
– With the help of Ros Krasny and Erik Wasson