BREAKING NEWS Death investigation at Olmsted County intersection Full Story

President Trump announces plasma treatment authorized for COVID-19

President Donald Trump salutes as he arrives at the Eastern Iowa Airport for a briefing on flood damage, Tuesday, Aug. 18, 2020, in Cedar Rapids, Iowa. (AP Photo/Evan Vucci)

President Donald Trump says the federal government has granted emergency authorization for treating COVID-19 patients with convalescent plasma.

Posted: Aug 23, 2020 3:46 PM
Updated: Aug 23, 2020 6:53 PM

WASHINGTON (AP) — President Donald Trump on announced emergency authorization to treat COVID-19 patients with convalescent plasma — a move he called “a breakthrough,” one of his top health officials called “promising” and other health experts said needs more study before it's celebrated.

The announcement came after White House officials complained there were politically motivated delays by the Food and Drug Administration in approving a vaccine and therapeutics for the disease that has upended Trump’s reelection chances.

On the eve of the Republican National Convention, Trump put himself at the center of the FDA's announcement of the authorization at a news conference Sunday evening. The authorization makes it easier for some patients to obtain the treatment but is not the same as full FDA approval.

The blood plasma, taken from patients who have recovered from the coronavirus and rich in antibodies, may provide benefits to those battling the disease. But the evidence so far has not been conclusive about whether it works, when to administer it and what dose is needed.

In a letter describing the emergency authorization, the chief scientist for the FDA, Denise Hinton, said: “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.”

But Trump had made clear to aides that he was eager to showcase good news in the battle against the virus, and the timing allowed him to head into his convention with momentum. He and aides billed it as a “major" development and used the White House briefing room to make the announcement.

Trump also displayed some rare discipline in the evening news conference, sticking to his talking points, deferring to the head of the FDA, Stephen Hahn, and only taking three questions from reporters.

The White House had grown agitated with the pace of the plasma approval. The accusations of an FDA slowdown, which were presented without evidence, were just the latest assault from Trump’s team on what he refers to as the “deep state” bureaucracy. White House chief of staff Mark Meadows did not deal in specifics, but said that “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.”

“This president is about cutting red tape,” Meadows said in an interview Sunday on “This Week" on ABC. “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.”

During Sunday’s 18-minute press conference, Trump said he thought there had been a “logjam” at the FDA over granting the emergency authorization. He alleged there are people at the FDA “that can see things being held up ... and that’s for political reasons.”

Dr. Joshua Sharfstein said the statement, and Hahn’s silence while Trump said it, “was disgraceful.”

“The FDA commissioner allowed basically allowed the president to mischaracterize the decision and attack the integrity of FDA employees. I was horrified,” said Sharfstein, a vice dean at John Hopkins University’s school of public health who was a top FDA official during the Obama administration.

“This is a promising therapy that has not been established,” he said

The push on Sunday came a day after 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 Trump aides have been banking on it being an “October surprise” that could help the president make up ground in the polls.

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

Earlier this month, Mayo Clinic researchers reported a strong hint that blood plasma from COVID-19 survivors helps other infected patients recover. But it wasn’t considered proof.

More than 70,000 patients in the U.S. have been given convalescent plasma, a century-old approach to fend off flu and measles before vaccines. It’s a go-to tactic when new diseases come along, and history suggests it works against some, but not all, infections.

The Mayo Clinic reported preliminary data from 35,000 coronavirus patients treated with plasma, and said there were fewer deaths among people given plasma within three days of diagnosis, and also among those given plasma containing the highest levels of virus-fighting antibodies.

But it wasn’t a formal study. The patients were treated in different ways in hospitals around the country as part of an FDA program designed to speed access to the experimental therapy. That “expanded access” program tracks what happens to the recipients, but it cannot prove the plasma — and not other care they received — was the real reason for improvement.

Administration officials, in a call with reporters Sunday, discussed a benefit for patients who were within three days of admission to a hospital and were not on a respirator, and were given ‘high-titer’ convalescent plasma containing higher concentrations of antibodies. They were then compared to similar patients who were given lower-titer plasma. The findings suggest deaths were 35% lower in the high-titer group.

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.

Aiming to ward off a possible a run on convalescent plasma after the announcement, government officials have been working to obtain plasma and to team with corporate partners and nonprofit organizations to generate interest among previously infected patients to donate.

Hahn, who called the development “promising," said Trump did not speak to him about the timing of the announcement. He said “this has been in the works for several weeks.”

But some health experts were skeptical. Benjamin Corb, of the American Society for Biochemistry and Molecular Biology, called it “conspicuous timing.”

“President Trump is once again putting his political goals ahead of the health and well-being of the American public," Corb said.

Rigorous studies are under way around the country, comparing similar patients randomly assigned to get plasma or a dummy infusion in addition to regular care. But those studies have been difficult to finish as the virus waxes and wanes in different cities. Also, some patients have requested plasma rather than agreeing to a study that might give them a placebo instead.

Former FDA commissioner Dr. 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.”

Trump, in news conferences, “has made all kinds of therapeutic suggestions” that 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 disinfectant. 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.

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

“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.

Minnesota Coronavirus Cases

Data is updated nightly.

Cases: 604608

Reported Deaths: 7642
CountyCasesDeaths
Hennepin1249941780
Ramsey52516897
Dakota46848471
Anoka42782458
Washington27433291
Stearns22559225
St. Louis18142313
Scott17552137
Wright16382149
Olmsted13401102
Sherburne1202495
Carver1067548
Clay826492
Rice8203110
Blue Earth762644
Crow Wing681795
Kandiyohi668185
Chisago620052
Otter Tail586284
Benton582998
Goodhue483974
Douglas475681
Mower470533
Winona461351
Itasca459963
Isanti440164
McLeod430861
Morrison424862
Beltrami407862
Nobles407550
Steele397816
Polk389072
Becker386755
Lyon363853
Carlton353056
Freeborn347133
Pine334923
Nicollet331345
Mille Lacs311854
Brown307940
Le Sueur297326
Cass286232
Todd285633
Meeker263443
Waseca238023
Martin235333
Roseau211221
Wabasha20793
Hubbard196641
Dodge18793
Renville182846
Redwood176539
Houston174616
Cottonwood167124
Wadena163423
Fillmore157610
Faribault154819
Chippewa154038
Pennington153820
Kanabec146828
Sibley146810
Aitkin138937
Watonwan13579
Rock128719
Jackson122812
Pipestone116726
Yellow Medicine115020
Pope11306
Murray107110
Swift106918
Koochiching95418
Stevens92411
Clearwater89016
Marshall88817
Lake83220
Wilkin83213
Lac qui Parle75622
Big Stone6044
Grant5948
Lincoln5853
Mahnomen5669
Norman5479
Kittson49022
Unassigned48293
Red Lake4017
Traverse3775
Lake of the Woods3453
Cook1720

Iowa Coronavirus Cases

Data is updated nightly.

Cases: 371146

Reported Deaths: 6053
CountyCasesDeaths
Polk58273640
Linn21228339
Scott20310248
Black Hawk16167312
Woodbury15241230
Johnson1462385
Dubuque13512211
Dallas1128999
Pottawattamie11229174
Story1071648
Warren584091
Clinton561593
Cerro Gordo554095
Sioux517674
Webster516094
Muscatine4884106
Marshall486876
Des Moines467572
Wapello4338122
Buena Vista426940
Jasper421172
Plymouth403181
Lee382356
Marion366076
Jones301057
Henry294537
Bremer288661
Carroll287152
Boone268634
Crawford268140
Benton259955
Washington257351
Dickinson249344
Mahaska232751
Jackson225242
Clay216727
Kossuth216166
Tama212071
Delaware211143
Winneshiek198835
Page194522
Buchanan194133
Cedar192323
Hardin187544
Fayette186743
Wright186040
Hamilton181951
Harrison180073
Clayton171157
Butler166335
Madison164619
Mills163724
Floyd163442
Cherokee159338
Lyon158841
Poweshiek157136
Allamakee152852
Hancock150334
Iowa149824
Winnebago144531
Cass139255
Calhoun138913
Grundy137333
Emmet135841
Jefferson133535
Shelby131737
Sac130920
Union130035
Louisa129749
Appanoose129049
Mitchell126643
Chickasaw124917
Franklin123523
Guthrie123332
Humboldt119626
Palo Alto113623
Howard105022
Montgomery103638
Clarke100924
Keokuk96832
Monroe96431
Unassigned9530
Ida91535
Adair87332
Pocahontas85822
Davis85225
Monona83131
Osceola78916
Greene78011
Lucas77923
Worth7618
Taylor66812
Fremont6269
Decatur6169
Ringgold56424
Van Buren56318
Wayne54423
Audubon53311
Adams3444
Rochester
Clear
67° wxIcon
Hi: 76° Lo: 48°
Feels Like: 67°
Mason City
Partly Cloudy
68° wxIcon
Hi: 80° Lo: 47°
Feels Like: 68°
Albert Lea
Partly Cloudy
68° wxIcon
Hi: 78° Lo: 47°
Feels Like: 68°
Austin
Partly Cloudy
66° wxIcon
Hi: 78° Lo: 47°
Feels Like: 66°
Charles City
Partly Cloudy
66° wxIcon
Hi: 78° Lo: 45°
Feels Like: 66°
Storm chances increasing for Thursday and Friday
KIMT Radar
KIMT Eye in the sky

Community Events