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FDA expediting use of a blood plasma coronavirus treatment as New York rolls out new clinical trials

The FDA said in a news release that it is “facilitating access” for patients with life threatening infections to blood plasma taken from a person who recovered after once testing positive for the virus.

It’s a treatment the state of New York is pursuing in clinical trials, Gov. Andrew Cuomo said Tuesday.

The process, known as plasma-derived therapy or “convalescent plasma,” involves doctors testing the plasma of people who recovered for antibodies to the virus and then injecting that plasma, or a derivative of it, into the sick person.

The move is a “big step” forward, said Dr. Arturo Casadevall, chief of molecular microbiology and immunology at Johns Hopkins Bloomberg School of Public Health, who has advocated for the plasma treatment.

“It has a high likelihood of working but we won’t know whether it works until its done” and enough patients have been treated, he said. “We do know based on history it has a good chance.”

Rolling out trials

The move comes as the US recorded its deadliest day since the outbreak began. More than 150 deaths from Covid-19, the disease caused by coronavirus, were reported in the US on Tuesday, according to a tally by CNN. At least 700 people in the US have died and more than 53,000 have tested positive for the virus.

Cuomo said his state is also pursuing testing people’s blood for antibodies and immunity to coronavirus.

“That would be very important for us to know because then healthcare workers that could go back to work, there are workers that could return back to the private sector.”

The New York State Department of Health is also rolling out clinical test trials for anti-malaria drug Hydroxychloroquine and the antibiotic Azithromycin. The patients who are hospitalized with moderate or severe coronavirus will be eligible to receive the treatment.

“Those are the patients that we think can have the greatest impact so we want to focus on them,” according to a New York health official.

A second New York University trial is exploring if Hydroxychloroquine can be used as a preventative measure to preemptively treat people who don’t have the virus but are in contact with those who do, according to an email seen by CNN that was sent by a member of the NY Health Department’s Institutional Review Board.

Logistics are the biggest issue

The New York health official said for the plasma treatment they will be recruiting patients from New Rochelle, which had the first cluster of cases in the state and now has a critical mass of people who have recovered.

Plasma treatments will take time to get off the ground.

Physicians will need to identify patients who now test negative for the disease, extract their plasma and have it tested for antibodies for Covid-19 before it can be deployed to ill patients. If there are enough antibodies in plasma it can kill the disease, some doctors say.

The FDA is limiting the plasma treatment to the most seriously ill patients.

The New York health official acknowledged finding a good candidate and providing plasma could take days, but the official said they are expediting this process to just a few days.

“The biggest issue is the logistics. You’ve got to find the people, you’ve got to test them, identify the right donors, donate plasma and get it to the people who need it. That involves logistics but it’s all doable we’re not talking about rocket science,” said Casadevall. He says he’s been overwhelmed with people who want to donate their plasma and doctors around the world who want to understand the potential treatment.

Casadevall has set up a website where he hopes to post more information in the next few days.

Plasma treatments have been used since 1900s

He anticipates doctors could know in as soon as one month whether the plasma treatment is working if they get enough volunteers to donate their plasma.

How we've overcome past pandemics

Plasma treatments have been used since the 1900s to treat infectious diseases like influenza and more recently Ebola. China has used this treatment in its Covid-19 positive patients and says it is working although US doctors have not yet seen the underlying data.

Casadevall said it’s largely safe but there are always risks, including whether someone passes along a pathogen that wasn’t identified earlier.

He said the treatment might not work if the patients are too critical. In 2009, he said, there was a trial to treat influenza using plasma but some of the patients were already too sick for the antibodies to work. He said their dire situation had less to do with the virus and more to do with inflammation.

In New York, he said, the treatment will be given to people who are already very ill, but he hopes it will get to the point where doctors can prescribe it to patients who are diagnosed much earlier.

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GOP Sen. Marsha Blackburn doesn’t want bad blood with Taylor Swift

In the documentary out Friday, Swift goes after Blackburn’s record as she gets emotional discussing with her parents and team about wanting to voice her opinion in the 2018 midterm elections, adding that she regrets not speaking out against Donald Trump during the 2016 election.

Swift, who had been reluctant to voice her political opinions in the past, broke her silence on politics during the 2018 midterms and endorsed Blackburn’s rival for Senate, Democrat Phil Bredesen, and another Democrat running in Tennessee in an Instagram post. In the post’s caption, Swift had said Blackburn’s voting record “appalls and terrifies me.”

Blackburn, a conservative lawmaker closely tied to the President, ended up winning her 2018 race by about 11 points, becoming the first female senator to represent her state.

Later in the documentary, Swift is shown reacting to Blackburn’s election victory, saying she “can’t believe it.”

“She gets to be the first female senator in Tennessee, and she’s Trump in a wig,” Swift says. “She represents no female interests. She won by being a female applying to the kind of female males want us to be in a horrendous 1950s world.”

The pop singer criticizes also Blackburn for her 2013 vote against the reauthorization of the Violence Against Women Act and stance against same-sex marriage.

“It’s really basic human rights, and it’s right and wrong at this point, and I can’t see another commercial and see her disguising these policies behind the words ‘Tennessee Christian values,'” Swift says, getting emotional. “Those aren’t Tennessee Christian values. I live in Tennessee. I am Christian. That’s not what we stand for.”

After Swift went public with her endorsement of Bredesen, Blackburn told Fox News at the time, “Of course I support women and I want violence to end against women.”

It seems the Republican senator doesn’t want bad blood between her and Swift, according to a statement provided to CNN.

“Taylor is an exceptionally gifted artist and songwriter, and Nashville is fortunate to be the center of her creative universe,” Blackburn said in the statement, first reported by Variety. “While there are policy issues on which we may always disagree, we do agree on the need to throw the entertainment community’s collective influence behind legislation protecting songwriters, musicians, and artists from censorship, copyright theft, and profiteering.”

She pointed to her and Democratic Rep. Jerry Nadler’s legislation, the Ask Musicians for Music Act, or AM-FM Act, that seeks to have radio services “pay fair market value” for the music they use.

Swift has been a vocal about concerns around the rights of singers and songwriters to profit from their own music.

“I welcome any further opportunities to work with Tennessee’s and the nation’s creative communities to protect intellectual property and ensure appropriate compensation for their creations. On that note, I wish Taylor the best — she’s earned it,” Blackburn added.

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Celebrity Entertaiment

Guitar god James ‘Blood’ Ulmer recalls when Soho was a garment district

With his freeform mix of jazz, blues and funk James “Blood” Ulmer was once described by Newsweek as “the most original guitarist since Jimi Hendrix and Wes Montgomery.”

The New York guitar god — who has played with such greats as saxophonist Ornette Coleman, while also getting in his licks as a bandleader and solo artist — will flex his skills Saturday at the Sultan Room in Brooklyn as part of this year’s Winter Jazzfest (running through Jan. 18).

Here, the 79-year-old axman spills on how he got his nickname, what instrument he wishes he could play and living in the same place in Soho since 1975.

Where did your nickname “Blood” come from?

Wow, you’re going back a looong time. You’re talking ’bout when I was 18 years old . . . I didn’t like the name that I had when I came to New York, I guess. So when somebody would ask what my name was, I would say “Youngblood.” And then I said “Youngblood” so long that I took off the “Young” and it just was “Blood.”

Which artists did you have in your blood growing up in South Carolina?

Well, when I was coming up, I started in gospel. The groups I liked the best were the Dixie Hummingbirds, the Five Blind Boys of Alabama and the National Clouds of Joy. We had a gospel group [led by Ulmer’s father] called the Southern Sons from when I was 7 years old till I was 13. I was singing in the group until I got good enough on the guitar to play.

How old were you when you started playing the guitar?

My daddy started me off when I was 4 years old. He put me on his lap and wrapped my hand around his fingers playing on the guitar. I don’t think he thought that was gonna [teach] me anything.

If you could go back and play another instrument besides guitar, what would you play?

I wanted to play the saxophone before I played the guitar. My daddy had a guitar in the house, and I didn’t think that should be something you’d wanna take up for a career or anything. I thought the guitar was just a part of the house. I really wanted to play the saxophone ’cause I had a friend who used to come down South to visit his family, and he had this little alto saxophone. I would go to his house, and I would want to play that horn.

Who are some of your favorite guitarists, past or present?

I used to like Wes Montgomery. And I loved Kenny Burrell — in fact, I copied one of his solos and played it for a while when I started. And George Benson is my friend. But I don’t really listen to other guitar players, because I be workin’ on my own guitar.

How has Soho changed over all the years you’ve lived there?

When I moved on this street, Spring Street between Greene and Mercer, they didn’t call it Soho. This was a garment district, and there was nobody living here — only artists coming down here and renting places to paint and play music and stuff like that. It’s really changed. And the prices have changed.

You turn 80 on Feb. 2. Did you ever imagine you’d still be playing music at 80?

Well, I’ve never done anything else. All I did all my life is play music.

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Breaking New

Officials Identify 59-Year-Old Grandmother Found Dead In ‘Pool Of Blood’ Inside East Germantown Home – CBS Philly

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