Pres. Trump pushes for COVID-19 treatments, claims slowdown at FDA

Aug 23, 2020, 12:57 PM

(Photo credit: Centers for Disease Control and Prevention)

BY JONATHAN LEMIRE AND MIKE STOBBE ASSOCIATED PRESS

KSLNewsRadio

WASHINGTON (AP) — Pushing for breakthroughs in treatments for the coronavirus, White House officials suggested Sunday there were politically motivated delays by the Food and Drug Administration in approving a vaccine and therapeutics for the disease.

The accusations, the latest assault from President Donald Trump’s team on the so-called “deep state” bureaucracy, were presented without evidence and just hours before Mr. Trump was set to hold a news conference to announce an apparent advancement in therapeutics.

“This president is about cutting red tape,” said White House chief of staff Mark Meadows. “He had to make sure that they felt the heat. If they don’t see the light, they need to feel the heat because the American people are suffering.”

The push on Sunday came a day after Pres. Trump tweeted sharp criticism on the process to treat the virus, which has killed more than 175,000 Americans and imperiled his reelection chances. The White House has sunk vast resources into an expedited process to develop a vaccine and Mr. Trump’s aides have been banking on it being an “October surprise” that could help the president make up ground in the polls.

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“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,” Pres. Trump tweeted. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”

Pres. Trump, who has been teasing progress in therapeutics for weeks, did not offer any evidence of a slowdown. The White House has also pushed the FDA to step up its approval of blood plasma authorization. Meadows did not deal in specifics, but said “we’ve looked at a number of people that are not being as diligent as they should be in terms of getting to the bottom of it.”

“We really need to make sure that we have good science and the proper protocol,” Meadows said in an interview on ABC’s “This Week.” “But we also can’t wait around and assume that this virus is going to go away. This president wants real results and that’s why he took to Twitter.”

White House press secretary Kayleigh McEnany tweeted that Mr. Trump, who spent the morning at his Virginia golf course, would later discuss a “major breakthrough on therapeutics” in a news conference and would be joined by Health and Human Services Secretary Alex Azar and Stephen Hahn, the head of the FDA.

Former FDA commissioner Scott Gottlieb dismissed the suggestion of a slowdown.

“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 told CBS’s “Face the Nation.”

Hundreds of drugs are currently being developed as possible treatments against the coronavirus infection, taking a range of approaches.

Many scientists currently believe that among those that offer the most hope are those that administer antibodies to a patient to help the body fight off the virus and stop any illness from progressing. One form of that is convalescent plasma, gathered from people who have already been infected. Another is artificially created monoclonal antibodies.

Convalescent plasma is already being tried at a number of hospitals, but there’s been little data on how effective it is or whether it must be administered fairly early in an illness to make a significant difference, said Dr. William Schaffner, an infectious diseases expert at Vanderbilt University.

Pres. Trump, in press conferences, “has made all kinds of therapeutic suggestions,” which have not proven to be supported by science — and are even dangerous, Schaffner said.

That includes statements about the possible value of treating COVID-19 patients with ultraviolet light and bleach. Mr. Trump reportedly also recently became enthusiastic about oleandrin, a plant extract derived from a toxic shrub that scientists immediately warned against.

But the president is perhaps best known for his early and ardent embrace of the malaria drugs hydroxychloroquine and chloroquine.

The FDA in late March granted emergency authorization for distribution of the drugs for treating COVID. But in June, the agency revoked the authorization in light of growing evidence they don’t work and could cause serious side effects.

Not only that, the FDA warned doctors against prescribing the drugs in combination with remdesivir, a drug that was shown to help patients with COVID-19. The FDA said the anti-malaria drugs can reduce the effectiveness of remdesivir, which the FDA cleared for emergency use in May.

Remdesivir is an intravenous medication, made by Gilead Sciences, that has been shown to help severely ill, hospitalized patients recover faster.

Some experts criticized the FDA for ever granting authorization to the anti-malaria drugs in the first place. One was Dr. Steven Nissen, a Cleveland Clinic researcher who has been a frequent FDA adviser.

“I don’t know what the influencing was at the time,” Nissen said. “I thought the evidence suggesting benefit was very flimsy,” while the potential risk to the heart for some patients was far more clear, he said.

Earlier this month, Hahn emphasized that routine evaluation procedures will remain in place to evaluate COVID vaccine candidates.

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. 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.

It was not clear if that was what prompted Pres. Trump’s tweet.

Nissen praised FDA’s staff scientists “as really fine public servants. They want to do the right thing. They can, however, be over-ruled by political leadership.”

The agency’s politically appointed leaders historically have not interfered with scientific decisions, he said, adding; “We need to keep it that way.”

“I think this administration has put more pressure on the Food and Drug Administration than I can remember” ever happening in the past, Schaffner said.

“Everybody is just a little bit nervous,” he said.
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Stobbe reported from New York.
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Follow Lemire on Twitter at http://twitter.com/@JonLemire and Stobbe at http://twitter.com/@mikestobbe

How To Prevent the Spread of COVID-19Coronavirus

COVID-19 coronavirusis transmitted from person to person. It is a virus that is similar to the common cold and the flu. So, to prevent it from spreading:

Wash hands frequently and thoroughly, with soap and water, for at least 20 seconds.
Don’t touch your face.
Keepchildren and those with compromised immune systemsaway from someone who is coughing or sneezing (in this instance, at least six feet)
If there is an outbreak near you, practice social distancing (stay at home, instead of going to the movies, sports events, or other activities.)
Get a flu shot.