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Trump sparks new FDA concerns with praise of ‘miracle’ treatment

President Trump’s public praise for an experimental coronavirus antibody treatment is putting new pressure on the Food and Drug Administration (FDA) to quickly give emergency clearance to a drug he has touted as a “miracle.”



a person sitting on a table: Trump sparks new FDA concerns with praise of 'miracle' treatment


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Trump sparks new FDA concerns with praise of ‘miracle’ treatment

Doctors think the drugs show promise as a potential treatment of COVID-19, though Trump has created confusion by quickly elevating them to a cure.

“They call them therapeutic, but to me it wasn’t therapeutic,” Trump said in a video he tweeted on Wednesday, five days after receiving the experimental treatment from the biotech company Regeneron.

Trump said that he felt better immediately after taking the drugs.

“I call that a cure,” he said. “It’s a cure.”

But by placing himself in the middle of the drug evaluation process, Trump is once again igniting concerns that politics is encroaching on science at a crucial time.

The pressure threatens to undermine confidence in government regulators and turn the science of drug evaluation into yet another political dispute, confusing Americans and sowing distrust about helpful therapies.

Former FDA Commissioner Scott Gottlieb said the agency should grant emergency authorization to antibody treatments like the one Trump took, and people shouldn’t be so quick to attack such a promising therapy.

“I hope people don’t shoot at these drugs because there’s this political veneer over access to this. We should just look at the scientific merits,” Gottlieb said Friday on CNBC.

Gottlieb also said the safety bar for antibody treatments is lower than it is for vaccines because the science for antibodies is better understood.

“These drugs, based on the data we’ve seen publicly, probably meet the bar for an emergency use authorization. They’re different from a vaccine, a vaccine you’re going to have a much higher threshold for safety,” Gottlieb said.

Two companies have filed for emergency use authorization for antibody drugs in the past week: Regeneron and Eli Lilly. The treatment from Eli Lilly consists of a single monoclonal antibody, while the treatment from Regeneron consists of a cocktail of antibodies.

Monoclonal antibodies are lab-generated versions of one of the human body’s main defenses against pathogens.

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Doctors and health experts think antibody drugs could be a bridge to a COVID-19 vaccine, but have cautioned that the results to date are very preliminary and longer studies are needed.

“I think there’s an efficacy signal here. But it’s a very selective part of the patient population,” said Jesse Goodman, a professor at Georgetown University who was FDA’s chief scientific officer during the Obama administration.

Regeneron issued a press release touting its preliminary results, but has not publicly released any data. According to the company, a high dose of its drug led to reduced levels of the virus in non-hospitalized patients with mild to moderate symptoms.

Eli Lilly’s submission was based on studies showing that its antibody

Trump drive-past for supporters sparks criticism [Video]

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BETHESDA, MARYLAND, UNITED STATESOCTOBER 4, 2020SOURCE: DC POOLRESTRICTIONS: NO RESALE

1. Tracking shot US President Donald Trump waves at supporters from a motorcade as it rolls down the street outside Walter Reed military hospital in Bethesda, Maryland, a man shouts, UPSOT: “God bless our president — I will die for him. I will die for that man happily. I’ll die for him.”2. Tracking shot US President Donald Trump’s motorcade rolls down the street outside Walter Reed, supporters can be heard cheering on the president

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newseriesTrump signals improving health with appearance for supporters By Brian Knowlton and Joshua Melvin

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ATTENTION – REFILES to fix typo in 8th graf ///Washington, Oct 4, 2020 (AFP) – US President Donald Trump waved at supporters from a motorcade Sunday on a short drive outside the hospital where he was being treated for Covid-19.The outing came minutes after the president had announced “a surprise” for fans, and it appeared designed to personally take back the narrative on his improving health after a weekend of confused and contradictory messaging from the White House and Trump’s medical team.Seen in a dark face mask and waving, the president rolled past delighted supporters before returning to the Walter Reed military hospital near Washington.”We’re going to pay a little surprise to some of the great patriots that we have out on the street,” Trump had said in a video posted to Twitter moments earlier.”I’m about to make a little surprise visit.”Trump, who has been repeatedly rebuked for flouting public health guidelines and spreading misinformation on the pandemic, added that he had “learned a lot about Covid” by “really going to school,” as he has battled the virus.”This is the real school. This isn’t the ‘let’s read the books school,’ and I get it, and I understand it, and it’s a very interesting thing,” he added.But the decision to leave his hospital suite was immediately criticized by the medical community, who voiced bafflement that the president wasn’t being kept isolated as he is treated for the highly contagious viral infection. “That Presidential SUV is not only bulletproof, but hermetically sealed against chemical attack,” said James Phillips, chief of disaster medicine at George Washington University.”The risk of COVID19 transmission inside is as high as it gets outside of medical procedures. The irresponsibility is astounding. My thoughts are with the Secret Service forced to play.”

– Confused messaging –

The episode came hours after a briefing by Trump’s medical team, who said he had “continued to improve” and could be returned to the White House, which has all the necessary equipment and expertise to continue his treatment, as early as Monday.”The president has continued to improve,” said his White House physician, Sean Conley. “As with any illness, there are frequent ups and downs over the course.”The president was flown to Walter Reed with a high fever on Friday after a “rapid progression” of his illness, with his oxygen levels dropping worryingly low, Conley said. Health experts have

Dying Mom’s Video of Hospital Staff Taunting Her Sparks Outrage Over Racism in Canada: Reports

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The death of an indigenous woman in the Canadian province of Quebec is sparking outcry and investigations after a shocking video showed her being verbally abused by hospital staff — and many believe it was racially motivated, according to multiple reports.

A heartbreaking livestream by Joyce Echaquan before her death on Monday depicts hospital staff members near her as she cried out in pain at Lanaudière Integrated Health and Social Services Center (CISSS) in Joliette. Echaquan’s Facebook Live footage — which was reviewed by local outlets and could be disturbing to some viewers — was publicly shared by Journal Métro and reportedly features nurses insulting the 37-year-old mother in French.

“You made some bad choices, my dear,” one of the nurses was recorded saying, according to The Guardian‘s translation. “What are your children going to think, seeing you like this?”

“She’s good at having sex, more than anything else,” another nurse said, according to the outlet.

One nurse was heard calling Echaquan “stupid as hell,” Canada’s CBC Television reported.

Echaquan’s husband, Carol Dubé, told the outlet that he believes the nurses meant to humiliate his wife.

“I have seven children who find themselves without a mother,” Dubé said. “I am sad. I am so sad.”

In a statement to PEOPLE, CISSS announced one of the two nurses who were recorded in Echaquan’s video has been fired.

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According to CBC, Echaquan was complaining of stomach pains when she arrived at the hospital two days before her death. A family member told the outlet she suffered from various health conditions and did not trust the hospital due to previous experiences.

“She always said, at the hospital, they never did anything,” Sebastien Moar, Echaquan’s cousin, told CBC. “They just made sure she wasn’t hurting. She always had appointments and she said the nurses seemed fed up with her.”

Two separate investigations — a coroner’s inquiry and an administrative probe — have been launched, the outlet added, citing the Quebec government.

Because she was a member of the Atikamekw people, a community of indigenous inhabitants in Quebec, some believe Echaquan’s treatment was seeded in racism.

“Joyce Echaquan went to the hospital for medical help. Instead, she was told she’s stupid, only good for sex and she would be better off dead as she pleaded for help before dying,” read a statement from the Native Women’s Association of Canada.

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“This racism in the health care system is deeply disturbing and unacceptable,” the group added.

This sentiment was echoed by Canadian Prime Minister Justin Trudeau, who called the hospital staff’s actions proof of “systemic racism” in the country.

“This is yet another example of systemic racism. It is quite simply unacceptable in Canada,” Trudeau said, according to the Toronto Star.

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