Deep state at FDA? No evidence of that

FDA.gov photo

Associated Press

A top FDA official who is overseeing COVID vaccine trials had vowed to resign if the Trump administration approves a vaccine before it is shown to be safe and effective

Hope Yen and Calvin Woodward

Associated Press

WASHINGTON — President Donald Trump is leveling unfounded attacks on his Food and Drug Administration and distorting the science on effective treatments for COVID-19.

Heading this week into the Republican National Convention, he asserted that the agency is slow-walking vaccines and treatments for the coronavirus in a bid to undermine his November reelection effort. There's no evidence of that, and one of his former FDA commissioners on Sunday rejected the accusation as groundless.

Trump also suggested anew that hydroxychloroquine is a proven and effective treatment for the coronavirus. It isn't. And Sunday evening, he announced emergency authorization to treat COVID-19 patients with convalescent plasma, a step he hailed as a historic breakthrough even though the treatment's value has not been established.

His weekend torrent of false and misleading claims follows a Democratic National Convention in which Joe Biden and his allies spun an assortment of facts to their benefit, omitting inconvenient truths such as Barack Obama's record of aggressive deportations and swift action by a Republican president to save the auto industry more than a decade ago.

A look at the past week's rhetoric, also covering the Pledge of Allegiance, the U.S. Postal Service and more:

CORONAVIRUS

TRUMP: "The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!" — tweet Saturday.

THE FACTS: No one has produced evidence that anyone at the FDA is delaying any treatment or vaccine for the coronavirus. 

During the pandemic, Trump has frequently contradicted or undercut the guidance of his government health experts, including at the FDA, and has asserted that a vaccine for COVID-19 could become available before the November election. But Dr. Anthony Fauci, the government's top infectious diseases expert, has said he is "cautiously optimistic" that a vaccine will be ready by early next year and that even then, it would not be widely available right away.

Under White House orders, federal health agencies and the Defense Department are carrying out a plan to deliver 300 million vaccine doses on a compressed timeline. That will happen only after the FDA determines that one or more vaccines are safe and effective. Several candidates are being tested.

The push for a speedy vaccine has drawn concern from some scientists that the White House will put pressure on U.S. regulators to approve a vaccine before it's ready.

A top FDA official who is overseeing COVID vaccine trials had vowed to resign if the Trump administration approves a vaccine before it is shown to be safe and effective. Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, made his promise during a conference call earlier in the month with pharmaceutical executives, government officials and others, Reuters reported Friday.

FDA Commissioner Stephen Hahn has said his agency will not be influenced by any political pressure and will make decisions "based solely on good science and data."

One of Trump's former FDA commissioners, Dr. Scott Gottlieb, said the president's charges are unfounded.

"I firmly reject the idea they would slow-walk anything or accelerate anything based on any political consideration or any consideration other than what is best for the public health and a real sense of mission to patients," Gottlieb said Sunday on CBS' "Face the Nation."

HISTORIC BREAKTHROUGH

TRUMP, announcing the emergency authorization for plasma treatment: "Very historic breakthrough ... that will save countless lives." — statement Sunday.

THE FACTS: That remains to be seen. The treatment's effectiveness has not been proved. It will take more research to know if it works well enough to merit FDA approval. There have been promising signs but no conclusions.

FDA chief scientist Denise Hinton made that clear, saying "COVID-19 convalescent plasma should not be considered a new standard of care for the treatment of patients with COVID-19. Additional data will be forthcoming from other analyses and ongoing, well-controlled clinical trials in the coming months."

The announcement on the eve of Trump's Republican National Convention raised suspicions among some scientists, who recalled Trump's overeager endorsement of other measures against COVID-19.

 "Conspicuous timing," said Benjamin Corb of the American Society for Biochemistry and Molecular Biology. "President Trump is once again putting his political goals ahead of the health and well-being of the American public."

THE FACTS

Trump, on the FDA revoking emergency use authorization of hydroxychloroquine for treating COVID-19: "Many doctors and studies disagree with this!" — tweet Saturday.

THE FACTS: Trump's continued promotion of the anti-malaria drug for COVID-19, with or without the antibiotic azithromycin. has been repeatedly dismissed by his own health experts. 

Numerous rigorous tests of hydroxychloroquine, including a large one from Britain and one led by the National Institutes of Health, concluded that the anti-malaria drug was ineffective for treating hospitalized coronavirus patients. 

Trump's health agencies as well as Fauci, who leads the National Institute of Allergy and Infectious Diseases at NIH, have cautioned that taking hydroxychloroquine to stave off the virus could be dangerous due to side effects. If the president is to be believed, he took the drug himself.

Adm. Brett Giroir, the administration's lead official on testing, made clear this month he does not recommend the treatment and said people need to "move on" and "talk about what is effective."

NEW ZEALAND'S RESPONSE

Trump on New Zealand and the coronavirus: "They had a massive breakout yesterday." — remarks Thursday in Old Forge, Pennsylvania.

Trump: False. New Zealand has had nothing resembling a massive outbreak or, as he also put it during the week, even a "big surge" or a "big outbreak."

New Zealand reported five to 13 new cases each day in the past week, as of Friday. The U.S. reported an average of some 46,000 per day during the week.

Trump is unhappy that New Zealand's success in controlling the virus, through its tight and early rules on distancing and closures, has been used for unfavorable comparisons with his pandemic response. New Zealand went for several months without any new, confirmed cases of locally spread COVID-19 before infection started showing up again in small numbers.

The infection, as of Friday, had killed 22 people in New Zealand and 174,000 in the U.S.

That's a rate of 4.5 deaths per million in New Zealand and 532 per million in the U.S. 

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