Reuters: U.S.

Monday, June 15, 2020

Overnight Health Care: FDA withdraws emergency use authorization for hydroxychloroquine | Surging coronavirus cases raise fears of new lockdowns | Trump on coronavirus: 'If we stop testing right now, we'd have very few cases, if any'

 
 
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Welcome to Monday's Overnight Health Care.

There are now more than 2 million COVID-19 infections in the U.S., according to Johns Hopkins University. More than 116,000 people have died.

The FDA revoked the emergency authorization for chloroquine and hydroxychloroquine, President Trump's favored coronavirus treatments. 

Cases are surging in states across the country, but Trump and Vice President Pence said the rise is due to increased testing. They continue to push states to reopen their economies, quickly, despite the spikes.

We'll start with hydroxychloroquine:

FDA withdraws emergency use authorization for hydroxychloroquine

The Food and Drug Administration (FDA) has withdrawn the emergency use authorization for chloroquine and hydroxychloroquine, two drugs promoted by President Trump to treat COVID-19, because of serious safety issues.

According to FDA, recent clinical trial failures mean the drugs may not be effective at treating COVID-19 or preventing it in people who have been exposed, and that their potential benefits do not outweigh the risks. FDA noted that the request to remove the authorization was an “interagency effort” prompted by new clinical trial results and other information.

Despite limited evidence of its effectiveness, at best, Trump has spent months promoting the drugs as a potential miracle treatment for COVID-19.

The FDA issued the emergency use authorization in March, soon after Trump began touting the drug. Critics accused the agency of caving to pressure from the administration, which the FDA has denied.

Last month, Trump said he had been taking hydroxychloroquine, in combination with zinc, as a way to prevent getting COVID-19 after a White House aide was diagnosed with the disease, which is caused by the novel coronavirus. He said he felt fine after finishing his regimen, and even said he would take the drugs again if he was ever exposed to coronavirus. 

What it means: The revocation of the emergency authorization should likely bring to an end the saga of administration efforts to promote the use of hydroxychloroquine to either treat or prevent COVID-19. The drugs remain on the market and approved for use in treating diseases like lupus and rheumatoid arthritis. 

Read more here.

One more nail: Late on Monday, the FDA also warned doctors against co-prescribing hydroxychloroquine or chloroquine with remdesivir, the only drug so far that's shown any promise in treating COVID patients. The FDA said using the drugs together "is not recommended as it may result in reduced antiviral activity of remdesivir."

Surging coronavirus cases raise fears of new lockdowns

If it was not clear already, the coronavirus is not going away anytime soon, and is spiking in several states, particularly across the south and west. 

That’s led some officials to pause the reopening of their economies. 

The rising number of cases are hitting hardest in Sun Belt states like Arizona, California, Florida and Texas. All four of those states reported their highest single-day increase in the number of confirmed cases over the weekend.

“If the trends we’re seeing right now get worse or continue to rise we are at a very high risk of getting to the point where the threat to our hospital system is severe and we have to backtrack,” Lina Hidalgo, the county judge in Harris County, Texas, told reporters on Thursday.

But is there the political will? “I don’t think there will be new shutdowns. There isn’t the political will to do it any longer it seems,” said Christine Petersen, an epidemiologist at the University of Iowa. “Now we are in the pandemic wild west.”

Read more here

Related: Alabama breaks single-day coronavirus record four straight days

South Carolina counts highest number of new cases for fourth consecutive day

Cuomo threatens to reverse localities' reopening, singling out Manhattan and Hamptons

But Trump thinks the increase is all a result of testing. 

"If we stop testing right now, we’d have very few cases, if any,” President Trump said Monday during a White House event highlighting administration actions to help senior citizens.

Trump has frequently made inconsistent comments on testing. At times he has sought to downplay the severity of the coronavirus pandemic by saying the U.S. has tested more people than any other country, and as a result, its number of confirmed cases is higher.

Other times, Trump has complained that the positivity rates and case counts are too high, because the country has been testing so many people.

Of note: The spike is not all because of an increase in testing. Some states have seen the number of daily tests decline even as the seven-day average of new cases increases. In other states, the rate of new cases is increasing faster than the increase in the average number of tests. 

The percentage of positive test results out of total tests has also been on the rise.

Read more here.

Bipartisan senators call for making telehealth expansion permanent post-coronavirus

Coronavirus has brought a lot of changes in the ability to virtually see a doctor. Now senators want to make those changes permanent. 

A group of 30 senators from both sides of the aisle wrote to Senate Majority Leader Mitch McConnell (R-Ky.) and Senate Minority Leader Charles Schumer (D-N.Y.) calls for provisions from the CONNECT for Health Act included in previous COVID-19 legislation be extended after the public health emergency is over.

“Americans have benefited significantly from this expansion of telehealth and have come to rely on its availability,” said the lawmakers led by Sens. Brian Schatz (D-Hawaii) and Roger Wicker (R-Miss.). “Congress should expand access to telehealth services on a permanent basis so that telehealth remains an option for all Medicare beneficiaries both now and after the pandemic."

Read more here

Planned Parenthood endorses Biden

Planned Parenthood Action Fund endorsed Joe Biden for president Monday in hopes that he will roll back actions taken by the Trump administration against abortion rights.

The endorsement, though unsurprising, comes after a primary in which Biden was pressed by those on the left over his long and varied history on the issue.

“Joe Biden is the only candidate in this race who will stand up for our health and our rights,” Alexis McGill Johnson, acting president of Planned Parenthood Action Fund, said in a statement Monday.

"This election we have a choice — between Donald Trump, whose incompetence and disregard for the law are a danger to us all, and Joe Biden, who is committed to fighting for reproductive health and rights for all," she said.

Why it matters: Biden has a long, complicated history on the abortion issue, coming from a Catholic background. But abortion-rights groups say he has “grown” on the issue and they’re ready to embrace him over Trump, who has undercut access to abortion at every possible opportunity. 

Read more here.

What we’re reading

Why a 2nd shutdown over coronavirus might be worse than the 1st — and how to prevent it (CNN.com

Postcard from the edge: A rural getaway, protected from Covid-19, fears it may be swallowed into the pandemic (Stat News)

Republican congressman who just announced he has coronavirus refused to wear a face mask on the House floor 2 weeks ago (Business Insider)

China's new coronavirus outbreak sees Beijing adopt 'wartime' measures as capital races to contain spread (CNN.com)  

State by state 

DC to give update this week on when phase 2 reopening can begin (NBC Washington)

Health experts link rise in Arizona coronavirus cases to end of stay-at-home order (NPR)

Texas calls in a strike force to try to slow coronavirus spread in nursing homes (NPR)

California bars, zoos and more reopen as state passes 5,000 dead (Sacramento Bee)

Op-eds in The Hill

Employers have critical role to prevent second wave of cases

How we can protest for justice without spreading COVID-19

What women want: Affordable, shoppable health care

 
 
 
 
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