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: 690391

Reported Deaths: 8104
CountyCasesDeaths
Hennepin1417751856
Ramsey59044950
Dakota52670498
Anoka48579482
Washington30969309
Stearns25163241
St. Louis20636336
Scott19872145
Wright18754163
Olmsted16057111
Sherburne13701104
Carver1224752
Clay926795
Rice9192121
Blue Earth881947
Crow Wing7905102
Kandiyohi749389
Chisago722958
Otter Tail678794
Benton6567101
Mower569138
Winona561352
Goodhue556680
Douglas541684
Itasca526471
Beltrami516972
McLeod512064
Steele510721
Isanti495670
Morrison472463
Nobles452950
Becker443759
Polk438675
Freeborn433838
Lyon398754
Carlton394459
Nicollet384047
Pine378426
Mille Lacs359360
Brown353044
Cass350635
Le Sueur344729
Todd327334
Meeker310249
Waseca294525
Martin267933
Wabasha24654
Dodge24575
Hubbard236141
Roseau234824
Houston206816
Redwood203542
Renville202448
Fillmore200210
Pennington193022
Wadena188926
Faribault182225
Sibley178410
Cottonwood178324
Chippewa172639
Kanabec166729
Aitkin156838
Watonwan156511
Rock140719
Jackson135112
Pope13468
Yellow Medicine126620
Pipestone125326
Koochiching121919
Stevens121511
Swift118819
Murray116010
Marshall105318
Clearwater104818
Lake92821
Wilkin90214
Lac qui Parle86824
Mahnomen7059
Big Stone6964
Grant6958
Norman6699
Lincoln6554
Kittson53522
Unassigned51793
Red Lake4927
Traverse4315
Lake of the Woods4114
Cook2150

Iowa Coronavirus Cases

Data is updated nightly.

Cases: 435755

Reported Deaths: 6339
CountyCasesDeaths
Polk67341672
Linn25698353
Scott22828261
Black Hawk19121334
Woodbury16940233
Johnson1659690
Dubuque14547218
Pottawattamie13058183
Dallas12746102
Story1187148
Unassigned93740
Warren685993
Webster6304102
Cerro Gordo6212102
Clinton620097
Des Moines594482
Muscatine5781108
Marshall564280
Sioux542775
Jasper516575
Lee511078
Wapello4993128
Buena Vista472942
Marion449083
Plymouth434083
Henry339940
Jones331158
Bremer325365
Crawford321644
Carroll317053
Washington315754
Benton312656
Boone308736
Mahaska275453
Dickinson270846
Kossuth251471
Jackson246044
Clay245729
Tama238273
Delaware234643
Buchanan233938
Hardin230847
Page221624
Cedar220525
Fayette220345
Wright217641
Winneshiek215937
Hamilton211752
Harrison198875
Clayton194458
Madison193820
Butler188836
Floyd187742
Mills185224
Poweshiek181036
Cherokee179440
Iowa176425
Allamakee176252
Lyon174441
Jefferson169138
Calhoun168313
Hancock167335
Winnebago164231
Grundy158835
Cass155556
Louisa154949
Shelby151739
Appanoose151249
Emmet149541
Franklin148524
Humboldt147226
Sac144722
Union144237
Mitchell141643
Guthrie138132
Chickasaw137518
Palo Alto131124
Clarke125024
Montgomery122239
Keokuk116232
Howard115622
Monroe114033
Ida107538
Davis103125
Pocahontas99023
Greene98012
Adair95334
Monona94733
Lucas94523
Worth9268
Osceola83717
Decatur74510
Fremont74111
Taylor72412
Van Buren70919
Wayne65123
Ringgold62226
Audubon58414
Adams3914
Rochester
Clear
52° wxIcon
Hi: 66° Lo: 44°
Feels Like: 52°
Mason City
Clear
50° wxIcon
Hi: 69° Lo: 41°
Feels Like: 50°
Albert Lea
Partly Cloudy
55° wxIcon
Hi: 68° Lo: 41°
Feels Like: 55°
Austin
Partly Cloudy
54° wxIcon
Hi: 67° Lo: 42°
Feels Like: 54°
Charles City
Partly Cloudy
55° wxIcon
Hi: 68° Lo: 43°
Feels Like: 55°
Cooler conditions continue through the week
KIMT Radar
KIMT Eye in the sky

Community Events