Before Trump pushes for new treatment for coronavirus, White House blows up FDA


When President Trump prepared on Sunday for what the White House called a breakthrough in the treatment of coronavirus, his former FDA chief said the president was exaggerating the significance of the therapeutic measure.

Scott Gottlieb, who was FDA commissioner from 2017-19, disputed Trump’s accusation of foothold by the agency, saying he believed it would move as quickly as possible to assess safe and effective means of fighting the virus, including the use of so-called convalescent plasma taken from recovered COVID-19 patients.

‘I reject the idea that she [the FDA] “Everything for that matter is slowly evolving or accelerating, based on any kind of political consideration and any consideration other than what is best for public health,” Gottlieb told CBS ” Face the Nation. ‘

The president’s attack on the FDA comes against the backdrop of public opinion polls suggesting that about two-thirds of Americans do not approve of his handling of the pandemic, which has hit the United States harder affected as another advanced country.

At last week’s Democratic convention, Trump’s pandemic policy was excoriated, and the grim course of the outbreak is expected to become a central focus of the campaign by Democrats’ nominee, former Vice President Joe Biden. Trump will formally accept the Republican presidential nomination this week.

The president – who has often sought to clear the blame for failures in fighting the virus that has killed more than 175,000 Americans – suggested in a tweet last Saturday that a shaky “deep state” was trying to hurt its outreach prospects.

That, he implied, might prevent the FDA from making rapid progress with regulatory approval of treatments for COVID-19, the disease caused by the virus. “Must focus on speed, and saving lives!” he wrote.

In appearances on Sunday’s news talk shows, Trump’s chief of staff, Mark Meadows, provided no evidence to accuse the president’s claim of a deliberate reduction in coronavirus therapeutic approvals, blaming ‘bureaucrats’. t think they can do it just like they normally do. “

“The president’s right to call it quits,” he told CNN.

In a separate appearance on “This Week of ABC,” Meadows reinforced the idea that the current FDA chief, Stephen Hahn – tagged in Trump’s tweet, and due to appearance on the president’s page later Sunday – was in the sick mercy of the White House.

“It’s almost impossible to fire a federal employee, despite what they’re doing wrong,” he said.

Trump had plans to announce what the president’s press secretary, Kayleigh McEnany, described last Saturday as a “breakthrough” in treating the coronavirus, which they refer to with a racist slur that is commonly used by the the president.

Gottlieb, in his CBS interview, said the persistent flap about the FDA’s role in plasma recovery, the fluid portion of blood collected from patients recovering from COVID-19. Such patients develop blood antibodies against the virus that can help fight infection.

Although the plasma is already in use for a limited number of patients, and clinical trials are underway, Trump blew up the FDA last week for a decision against authorizing its emergency use, according to relatively narrow data from the National Institutes of Health. quoted. An authorization for emergency use allows the passage of stricter threads.

“I believe plasma is probably beneficial,” Gottlieb said. ‘But I think some people wanted richer data to justify that decision. And I think this is part of what’s going on here with regard to that tweet, and questions about FDA decision making. ”

In the CBS interview, he described convalescent plasma as “incremental” added value as treatment.

During the course of the pandemic, Trump has frequently encountered scientists in public, including Dr. Anthony Fauci, the expert on the best infectious disease.

The president has denigrated mask-wearing, which is recommended by virtually all public health professionals, and is touting the use of hydroxychloroquine, an anti-malarial drug indicated in controlled clinical trials, to provide no benefit in treatment of COVID-19.

The president also drew widespread ridicule earlier this year when he thought the ingestion of disinfectant might be worth a treatment. Poison hotlines and a number of public officials then took to the airwaves and social media to plead people not to drink pale.

In late spring and early summer, Trump also urged administrators to reopen their states, whether or not they had containment benchmarks set by his own administration. In several major Sunbelt states, including Texas and Florida, that policy has been accused of igniting some of the most serious outbreaks to date, which are now disappearing but moving to other parts of the country.

New daily cases have dropped below 50,000 for more than a week, and deaths, which have remained at 1,000 per day for the past four weeks, are likely to fall below that level.

‘The concern is that if there is a sort of a third wave, a third iteration of the national epidemic, it could be more diffuse, spreading across a wider section of the Midwest and the West, because there are cases build in those parts of the country, ”said Gottlieb. “And that’s what people are doing right now.”