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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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U.S. rolls back standards on energy saving light bulbs


FILE PHOTO: Illustration picture of the filament of an incandescent light bulb shot August 7, 2017. REUTERS/Denis Balibouse/Illustration

WASHINGTON (Reuters) – The Trump administration on Friday said it has finalized a decision to roll back a 2007 rule calling for energy-efficient light bulbs, a move that states including New York and California are challenging in the courts.

The administration finalized a proposal made in September to roll back the standard that Congress passed in 2007 when George W. Bush, a Republican, was president and which was to come into effect next year. The Department of Energy said that increasing the efficiency of bulbs could cost consumers more than 300% compared to incandescent bulbs and that Americans do not need regulation because many are already buying efficient bulbs.

“The American people will continue to have a choice on how they light their homes,” said Energy Secretary Dan Brouillette.

The move is part of the administration’s push to ease regulations by requiring agencies to ditch two old regulations for each one they propose. The administration has also rolled back Obama-era regulations on pollution and emissions as it seeks to maximize oil, gas and coal production.

The roll back on light bulbs has been challenged in court by 15 states and Washington, D.C. who say it would harm state efforts to fight emissions blamed for climate change.

Environmental groups decried the decision. The Natural Resources Defense Council, a nonprofit, said it would cost consumers $14 billion in energy bills annually and create the need to generate the amount of electricity provided by an additional 30 500-megawatt power plants.

The NRDC said old-fashioned incandescent bulbs, which give off more of their energy in heat rather than light, comprise nearly half of today’s bulb sales.

“The Trump administration just thumbed its nose at Congress, America’s families and businesses, and the environment,” said Noah Horowitz, an energy efficiency specialist at the NRDC.

Reporting by Timothy Gardner, Editing by Franklin Paul and Chizu Nomiyama



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New ruling means Supreme Court dodges Obamacare showdown, but legal fight rolls on


The New Orleans-based court ruled unconstitutional the individual insurance mandate — which the federal government was no longer enforcing — yet refused to resolve the most pressing issue: does that mean the rest of the law is also unconstitutional?

By a 2-1 vote, the appeals panel returned the case to a US district court judge for the start of another round of rulings.

It will now likely be months, perhaps even years, before the US Supreme Court could ultimately resolve the merits of a challenge to the sweeping law known as Obamacare, which guaranteed coverage for people with pre-existing conditions, such as diabetes and cancer, expanded Medicaid, and allowed children to stay on their parents’ health insurance plans until they turn 26.

For Chief Justice John Roberts and his eight colleagues, Wednesday’s decision all but guarantees they will not face yet another contentious dilemma in the upcoming election year. The Supreme Court already has on its calendar disputes over abortion, immigration, gun control and LGBTQ rights. Last week, they added three cases involving President Donald Trump’s effort to block investigators’ subpoenas issued to his longstanding accountants and banks.

And Roberts will also be spending part of January at the US Capitol, overseeing the Senate’s impeachment trial of Trump.
It was during an election year, 2012, that the Supreme Court first took up the constitutionality of the law President Barack Obama signed in 2010. That decision saving Obamacare came on a 5-4 vote but only after Roberts switched his vote in dramatic negotiations with the court’s liberals behind the scenes and upheld the law as a tax.

He joined the four liberal justices, over protests of his conservative brethren, to uphold the individual insurance mandate. The scars of that internal fight, and some public criticism from conservatives, have not fully healed.

READ: Appeals court ruling on Affordable Care Act

But now, new pressure on the Supreme Court to resolve the new controversy may extend beyond the 2020 presidential election. That would likely be a relief to a chief justice who has tried to shield the court from the polarization of today’s Washington. In public appearances, he has increasingly declared that the justices do not engage in politics and should be regarded as neutral decision-makers, unbound from the presidents who appointed them.

In Wednesday’s ruling, the two judges in the majority affirmed US District Court Judge Reed O’Connor’s 2018 decision against the individual insurance mandate but shunned his decision invalidating the whole law. They said O’Connor failed to sufficiently weigh which provisions Congress intended to tie to the individual mandate.

Judges Jennifer Walker Elrod and Kurt Engelhardt, both Republican appointees, said O’Connor did not do “the necessary legwork of parsing through the over 900 pages of the post-2017 ACA, explaining how particular segments are inextricably linked to the individual mandate.” They said he must “employ a finer-toothed comb” for “a more searching inquiry into which provisions of the ACA Congress intended to be inseverable from the individual mandate.”

Those judges also criticized the Trump administration, which has been trying to kill Obamacare, for shifting positions throughout the litigation. At the same time, their decision spares the administration from an escalating legal battle in the upcoming election year.

Where the case is headed

Roberts’ original ruling in 2012 is one factor that generated the current lawsuit.

Texas and other Republican-led states had sued to eliminate Obamacare after the Republican-led Congress in 2017 cut to zero the tax penalty for people who did not abide by the mandate to buy insurance. When the Roberts majority upheld the individual insurance requirement, it based on Congress’ taxing power.

Now, because the individual mandate is no longer tied to a tax penalty, the states and the Trump administration argued, the mandate and the whole law should be struck down.

The inside story of how John Roberts negotiated to save Obamacare

Judge Carolyn Dineen King, a Democratic appointee, dissented from the appeals court majority’s voiding of the insurance requirement and said her colleagues on the panel should have left it at that. She insisted Congress would not have wanted the entire law to fall because of the tax change. Returning the case to a lower court for a “do-over,” King said, “will unnecessarily prolong this litigation and the concomitant uncertainty over the future of the healthcare sector.”

“It is unlikely that Congress would want a statute on which millions of people rely for their health care and livelihood to disappear overnight with the wave of a judicial wand,” King wrote.

Still, Wednesday’s decision does ensure that the law that Trump has railed against survives for the near future. If the appeals court panel had affirmed O’Connor’s ruling, it would have gutted Obamacare and produced another immediate showdown at the Supreme Court.

Such a ruling also could have incited new criticism against the Trump administration. Many provisions of Obamacare, including those that protect people with preexisting conditions or allow young adults to stay on their parents’ policies, remain popular.

Some high court legal action may yet be possible, however.

California Attorney General Xavier Becerra, leading the group of states defending the law, suggested he would petition the Supreme Court to take up the case even before the lower court judges had addressed which parts of the law should be invalidated. It is exceedingly rare for the high court to accept a case that had not yet been aired and resolved by lower court judges.

How the last chief justice handled an impeachment trial of the President of the United States

Judges on the 5th US Circuit Court of Appeals observed that the Trump administration had argued this year that the entirety of the ACA should fall with the individual mandate, a position that marked “a significant change.” When the case was argued before O’Connor, the administration said that only the guaranteed-issue and community-rating provisions were inseverable and therefore doomed.

After the ruling, Trump declared on Twitter that his administration “continues to work to provide access to high-quality healthcare at a price you can afford, while strongly protecting those with pre-existing conditions.”

But as the appeals court noted when it referred to the administration’s shifts throughout the litigation, the Trump administration’s legal position, in fact, would not have protected people with pre-existing conditions.



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Georgia removes more than 300,000 inactive voters from rolls



The removal comes as part of a new state provision signed into law earlier this year. Under the provision, the state must remove registration records from the voter rolls that have been deemed “inactive” for more than three years. A voter is categorized as “inactive” if they don’t vote in two general elections and have had no contact with board of elections in that time, according to Secretary of State Brad Raffensperger’s office.

About 313,000 voters were removed from the list, or about 4% of all registered voters in the state, according to the Secretary of State. The “inactive” voters were marked for removal after failing to respond to a pre-addressed, postage paid confirmation card within 30 days; the card asked voters to confirm or update their information.

State officials mailed out notices to the last known address of voters and posted the list of people online.

Fair Fight Action, a voting rights organization founded by Democrat Stacey Abrams, filed an emergency motion in federal court on Monday challenging the removal of a portion of the list — 120,000 voters who were removed due to inactivity since the 2012 presidential election.

The group is in the midst of a federal case against Raffensperger over the so-called “use it or lose it” policy, which allows registrations to be canceled after voters fail to participate in elections for several years.

“In our view, it is a First Amendment right not to vote, and it is unconstitutional to take away a Georgian’s right to vote simply because they have not expressed that right in recent elections,” Fair Fight Action spokesman Seth Bringman said. “309,000 is the total purge. This also includes people who had returned mail, passed away, or informed the state that they moved. In our view, these are appropriate reasons for a Georgia voter to be removed from the rolls, but ‘use it or lose it’ is not.”

The group went before US District Court Judge Steve C. Jones to fight the move on Monday afternoon. The judge allowed the removal to go forward and will hear arguments from the state and Fair Fight Action on Thursday.

Walter Jones, a spokesman for the Secretary of State, said the removal of the voters is not a “purge” but part of routine maintenance on voting lists that dates back to the National Voter Registration Act of 1993. Similar updates to voting rolls have happened in states like Illinois and Wisconsin, which most recently removed 234,000 people from its voter rolls.

The policy is meant to keep an accurate and fair count during elections and also help with planning of polling site equipment during election cycles, according to Georgia state officials.

According to Fair Fight Action’s Bringman, the Secretary of State said it did not have the technical capacity to stop the purge from taking place, but that it will reinstate the voters if ordered to do so.

Jones echoed this policy, telling CNN that though the list has been revised, the information of “inactive” voters is still in the state database and could be made “active” through re-registration or an update of address on a state drivers license.

This isn’t the first time the state has faced controversy surrounding voter list updates. In July 2017, more than half a million registered voters, or 8%, were removed from the rolls; of that total, more than 107,000 were removed for inactivity in recent elections, according to a report from APM.
The state also came under fire in October 2018 when then-Secretary of State Brian Kemp — then the Republican nominee for Georgia governor — enforced a policy of “exact match.” Under the policy, the most minor discrepancy, like a typo or missing letter, between a voter’s registration and their drivers license, Social Security or state ID cards was flagged, leading to more than 53,000 voter applications being put on hold. The majority, seven out of 10, belonged to African-Amercans.
Ahead of the recent removal, Georgia had roughly 7.4 million registered voters. Under the new roll count, there are about 7.08 million registered voters. According to Jones, an estimated 460,000 new registered voters were added within the 2018 election cycle, which included the tight race for governor in which Abrams lost to Kemp by a mere 68,000 votes.

Correction: This story has been updated to accurately reflect the number and percentage of voters who were removed from Georgia’s voter rolls.

CNN’s Gregory Krieg contributed to this story.



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Celebrity Entertaiment

‘The Marvelous Mrs. Maisel’ bus tour rolls into NYC



Here’s your chance to walk — or ride — a few miles in Midge Maisel’s vintage shoes.

On Location Tours is launching a bus and walking tour of the restaurants, bars and more visited by rising stand-up comic Mrs. Maisel (Rachel Brosnahan) in the Amazon Prime series “The Marvelous Mrs. Maisel.” The 20-year-old company is known for its sightseeing trips to New York City locations used in shows like “Sex & the City,” “Gossip Girl,” “The Sopranos” and “Seinfeld.”

The 2 1/2-hour “Mrs. Maisel’s Marvelous Tour of New York City,” launching Dec. 16, will visit numerous recognizable locales from the show, which is set in 1950s and 1960s Manhattan and kicks off its third season Friday.

While the new season will have less of a New York-centric vibe — focusing more on Midge’s new national tour that takes her to cities including Miami and Las Vegas — the On Location trip will visit a number of key locations made famous in the show’s first two seasons.

The tour — beginning at noon on Mondays, Thursdays and Saturdays — will rumble to places such as the former B. Altman department store (now a campus of the City University of New York) at 34th Street and Fifth Avenue, where Midge worked; The Village Vanguard, where she saw Lenny Bruce (played by Luke Kirby) perform; and the Gaslight, the club where Midge got her rocky start in stand-up comedy.

Series co-creator Amy Sherman-Palladino previously told The Post that getting out and filming on location is key to the dramedy’s appeal. “The show will not work if it becomes a series of people talking in rooms,” she said in 2017. “We have the strong downtown scenes. And that sterile Midtown look. And the Upper West Side. We really caught the flavor of those places.”

Advance tickets for the tour are $52.



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