President Donald Trump speaks during a media briefing in the James Brady Briefing Room of the White House, Sunday, Aug. 23, 2020, in Washington.(AP Photo/Alex Brandon)

President Donald Trump speaks during a media briefing in the James Brady Briefing Room of the White House, Sunday, Aug. 23, 2020, in Washington.(AP Photo/Alex Brandon)

Trump announces plasma treatment authorized for COVID-19

There’s no solid evidence yet that it fights the coronavirus and, if so, how best to use it

President Donald Trump announced Sunday the emergency authorization of convalescent plasma for COVID-19 patients, in 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 comes after days of White House officials suggesting 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 announced the authorization — which makes it easier for some patients to obtain the treatment — in a news conference Sunday evening.

The blood plasma, taken from patients who have recovered from the coronavirus and rich in antibodies, may provide benefits to those battling with 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, noted: “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.”

The White House had grown agitated with the pace of the plasma approval, but the accusations of a slowdown, which were presented without evidence, were just the latest assault from Trump’s team on 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 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.”

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!”

ALSO READ: Facebook, citing virus misinformation, deletes Trump post

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.

There’s no solid evidence yet that it fights the coronavirus and, if so, how best to use it.

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 so-called “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 non-profit organizations to generate interest among previously infected patients to donate.

The head of the FDA, Stephen Hahn, said Trump did not speak to him about the timing of the announcement, which comes just before a pivotal week for the president’s reelection chances. Hahn said “this has been in the works for several weeks” and came after a data validation for which the agency had been waiting.

Rigorous studies underway around the country are designed to get that proof, by 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.”

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

Trump, in news 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. 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.

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.

___

Stobbe reported from New York.

___

Jonathan Lemire And Mike Stobbe, The Associated Press


Like us on Facebook and follow us on Twitter.

Want to support local journalism during the pandemic? Make a donation here.

CoronavirusDonald TrumpUSA

Get local stories you won't find anywhere else right to your inbox.
Sign up here

Just Posted

Rose Sawka, a 91-year old Acropolis Manor resident received her COVID-19 vaccination on Jan. 20, one day after an outbreak was declared at the long-term care facility. Her son Terry Sawka visited with her through the window, like she is seen in an Oct. 2020 photo. (Photo: K-J Millar/The Northern View)
Acropolis Manor COVID-19 cases jump to 20 confirmed

Prince Rupert long term care facility received vaccinations

Illicit drug use has spread in the Northern Health region and overdose emergency calls increased in Prince Rupert by 29.5 per cent from 2019 to 2020. (Photo:THE NEWS/files)
Overdose emergency calls in Prince Rupert spikes by 43.6 % in five years

Northern Health issues illicit drug use warnings

Glenn Hall, resident at Yellowhead Pioneer Residence Assisted Living in Barrierem B.C. received their first COVID-19 vaccinations on Jan. 19. (Pam Simpson photo)
Acropolis residents and staff to receive COVID-19 vaccine

Prince Rupert long term care residents will receive the vaccine on Jan. 20

An outbreak of COVID-19 was declared on Jan. 19 at Acropolis Manor. The long-term care home also had an influenza outbreak nearly two years ago.
COVID-19 outbreak declared at Acropolis Manor

Prince Rupert long-term care home has four resident, three staff cases

Lax Kxeen Elementary School has two different active notices for potential COVID-19 exposure after three adult lab-confirmed cases of the virus were identified in Prince Rupert schools, School District 52 released in a statement on Jan. 18. (Photo K-J Millar/The Northern View)
Three adult COVID-19 cases result in four potential exposures in city schools

Prince Rupert School District 52 calls special open meeting

Maj.-Gen. Dany Fortin, vice-president of logistics and operations at the Public Health Agency of Canada, speaks at a news conference on the COVID-19 pandemic in Ottawa, on Friday, Jan. 15, 2021. THE CANADIAN PRESS/Justin Tang
B.C. records 500 new COVID-19 cases Wednesday, 14 deaths

Outbreak at Surrey Pretrial jail, two more in health care

A woman writes a message on a memorial mural wall by street artist James “Smokey Devil” Hardy during a memorial to remember victims of illicit drug overdose deaths on International Overdose Awareness Day, in the Downtown Eastside of Vancouver, on Monday, August 31, 2020. THE CANADIAN PRESS/Darryl Dyck
B.C. paramedics respond to record-breaking number of overdose calls in 2020

On the front lines, COVID-19 has not only led to more calls, but increased the complexity

Eighteen-year-old Aidan Webber died in a marine accident in 2019. He was a Canadian Junior BMX champion from Nanaimo. (Submitted)
Inadequate safety training a factor in teen BMX star’s workplace death in 2019

Aidan Webber was crushed by a barge at a fish farm near Port Hardy

Southern resident killer whales in B.C. waters. Research shows the population’s females are more negatively influenced by vessel traffic than males. (Photo supplied by Ocean Wise Conservation Association)
Female orcas less likely to feed in presence of vessel traffic: study

Research the southern resident population raises concerns over reproduction capacity

(Black Press Media files)
Transport Canada not budging on enclosed deck rules, despite calls from BC Ferries union

There have been at least 23 cases of the U.K. variant detected in Canada, four of which are in B.C.

The Elk Valley Hospital is adapting to meet the needs of patients in the Elk Valley.
1-in-5 COVID tests coming back positive in and around Fernie, sparking concern

Dr Ron Clark of Elk Valley Hospital said one in five tests was returning positive for COVID-19

Throughout December, RCMP conducted CounterAttack road checks as police worked to keep roads free of impaired drivers. (BLACK PRESS file photo)
‘You can’t make this stuff up’: Stories from the B.C. CounterAttack campaign

Amusing, yes, but a reminder impaired driving affects ability to drive and to make good decisions

(Thesendboys/Instagram)
Video of man doing backflip off Vancouver bridge draws police condemnation

Group says in Instagram story that they ‘don’t do it for the clout’

Inspection of bridge crossing on a B.C. forest service road. (B.C. Forest Practices Board)
B.C. falling behind in maintenance of forest service roads

Auditor finds nearly half of bridges overdue for repair

Most Read