Politico: FDA Loosens Rules For Distributing Abortion Pills, Opening New Battle Fronts 
The Food and Drug Administration on Thursday said it's lifting longstanding restrictions on abortion pills, clearing the way for doctors to prescribe the drugs online and have them mailed to patients or sent to local pharmacies. Enforcement of the agency’s decades-old rules requiring the pills to be physically handed out by a physician was suspended earlier this year following a lawsuit from the ACLU arguing that the risks of traveling to a doctor’s office during the Covid-19 pandemic outweighed any potential harms from having the drugs delivered. Now, the agency says it will move to make the looser distribution rules permanent. (Ollstein, 12/16)

Roll Call: FDA Loosens Restrictions On Medication Abortion Drug 
Under current regulations, a provider who wishes to prescribe medication abortions must be registered with the drug manufacturer to stock and dispense mifepristone, also known as RU-486. Some providers have criticized these additional steps as limiting access because it can be complicated and because many medical facilities may oppose stocking the drug. ... Medication abortion refers to a nonsurgical procedure that induces an abortion. It involves taking two pills — mifepristone and, 24 to 48 hours later, misoprostol — to cause an abortion or for miscarriage management. (Raman, 12/16)

Stat: FDA Lifts Key Restriction On Abortion Pill, Allowing It To Be Obtained By Mail 
The decision means that medication abortion may become more widely available to women who find it difficult to travel to abortion providers. Going forward, any doctor who is certified to prescribe the pill, which is known as mifepristone, can do so online and have it sent by mail, which will allow pregnancies to be terminated at home, even if the U.S. Supreme Court strikes down Roe v. Wade. “This is a very significant development,” said Daniel Grossman, a professor of obstetrics and gynecology, and reproductive sciences at the University of California, San Francisco, who has studied mifepristone dispensing. (Silverman, 12/16)

NPR: FDA Relaxes Restrictions On Access To Abortion Pill By Mail
Julia Kaye, an ACLU attorney, said years of data demonstrate that mifepristone is safe if used appropriately. "At this moment, with Roe v. Wade hanging by a thread, it is especially urgent that the federal government do everything in its power to follow the science and expand access to this safe, effective medication," Kaye said. Major medical groups including the American Medical Association argue that since mifepristone was approved by the Food and Drug Administration in 2000, it has built up a strong safety record. (McCammon and Franklin, 12/16)

In related news about abortion —

The Washington Post: Supreme Court Sends Texas Abortion Case To Appeals Court Instead Of To Judge Who Previously Blocked The Law
The Supreme Court returned the lawsuit over Texas’s restrictive abortion law to a federal appeals court Thursday, rejecting a request by abortion providers to send the case to a district judge who had previously declared the law unconstitutional. The order came from Justice Neil M. Gorsuch, who last week wrote the majority opinion that left in place the law, which bans most abortions after six weeks. The decision granted a narrow path for providers to challenge the law’s unique enforcement structure. (Barnes and Marimow, 12/16)

The New Yorker: Inside An Oklahoma City Abortion Clinic
The staff is struggling to meet the needs of Texas patients, with no relief in sight. (Watson, 12/16)

KHN: Abortion Rights Advocates Try To Change Opinions With Deeply Personal Conversations 
It’s Saturday, and Sarah Mahoney is one of several Planned Parenthood volunteers knocking on doors in Windham, Maine, a politically moderate town not far from Portland. No one answers at the first couple of houses. But as Mahoney heads up the street, she sees a woman out for a walk. “Hey! We’re out canvassing,” she says. “Would you mind having a conversation with us?” Mahoney wants to talk about abortion — not a typical topic for a conversation, especially with a stranger. But the woman, Kerry Kelchner, agrees to talk. If this were typical door-to-door canvassing, Mahoney might ask Kelchner about a political candidate, remind her to vote and then be on her way. But Mahoney is deep canvassing — a technique that employs longer conversations to move opinions on hot-button issues. (Wight, 12/17)

Politico: Biden Concedes Build Back Better Bill Won’t Get Passed This Year
President Joe Biden acknowledged Thursday that negotiations over his Build Back Better bill are poised to drag on into 2022 despite efforts and pledges by Democrats to get it done before Christmas. “It takes time to finalize these agreements, prepare the legislative changes, and finish all the parliamentary and procedural steps needed to enable a Senate vote,” the president said in a statement. He said that he spoke to Democratic leaders in Congress, Speaker Nancy Pelosi and Senate Majority Leader Chuck Schumer, earlier Thursday and they plan to “advance this work together over the days and weeks ahead; Leader Schumer and I are determined to see the bill successfully on the floor as early as possible.” (Thompson, 12/16)

Los Angeles Times: Democrats’ Social Spending Bill Falters Ahead Of Holiday Deadline
The approximately $1.75-trillion bill would fortify the nation’s social safety net by expanding tax credits under the Affordable Care Act, expanding Medicare to include hearing aids, and setting up a universal prekindergarten and child-care program, among other plans. It would also fund about $500 billion in programs addressing climate change. (Haberkorn and Stokols, 12/16)

The Hill: Biden's Build Back Better Bill Suddenly In Serious Danger 
But more importantly, there is also a chance the entire Build Back Better bill will have to be reworked to accommodate Sen. Joe Manchin’s (D-W.Va.) opposition to including a one-year extension of the expanded child tax credit in the bill. Manchin says he does not oppose the tax credit, which he has backed in past legislation. But he argues that because the credit is likely to be renewed over the next decade, its true cost is not reflected in the current bill's official Congressional Budget Office score. 2021 and allow senators to go home for Christmas. (Bolton, 12/16)

What's next for the bill? —

The Hill: Graham Says He Thinks Biden's Build Back Better Is 'Dead Forever'
Sen. Lindsey Graham (R-S.C.) on Wednesday said he thinks President Biden’s social spending and climate bill, the Build Back Better Act, is “dead forever” as Senate Democrats struggle to get their caucus unified behind the legislation. Graham pointed specifically to the wariness of Sen. Joe Manchin (D-W.Va.), who has signaled concerns about the roughly $2 trillion cost of the bill and its potential effects on inflation. (Schnell, 12/16)

Politico: Senate That 'Sucks' Gets A Dose Of Reality From Biden
House Progressive Caucus leader Pramila Jayapal (D-Wash.) said she spoke to Biden on Thursday and conveyed that she wants the Senate to stay in D.C. and keep working through the holidays. Senators are preparing to jet home after finishing work on some of Biden's nominees given the stubborn impasse. "The House did our work, and now it’s time for the Senate to do theirs. They must stay in session until Build Back Better is passed," Jayapal said.

Also —

PolitiFact: Context Needed For Grassley Comment About Medicare Vote
Democrats controlling the U.S. Senate with Vice President Kamala Harris’ tie-breaking vote came up with a plan earlier this month to circumvent the Senate’s 60-vote rule for raising the federal government’s debt ceiling: Combine in one bill a procedural vote saving Medicare from automatic funding cuts for 2022 with the unusual authorization of a one-time only Senate majority vote to raise the federal government’s debt limit. ... The ploy didn’t pass muster for Sen. Chuck Grassley, R-Iowa, though, who voted against the legislation. Grassley said he opposed the part that authorized raising the debt ceiling without a 60-vote Senate approval. That brought a response from Democrat Abby Finkenauer, the former U.S. representative from Iowa running in 2022 for the seat Grassley holds. Finkenauer tweeted on Dec. 9: "It’s not surprising that @ChuckGrassley would fight to preserve the filibuster while voting to slash Medicare, but it’s sure as heck not acceptable. D.C. hasn’t been working for DECADES and this guy is the problem." (Muller, 12/16)

USA Today: CDC Recommends Pfizer, Moderna COVID Vaccines Over J&J In Adults
A CDC panel voted Thursday to recommend the Pfizer-BioNTech and Moderna COVID-19 vaccines be preferred for adults over the Johnson & Johnson vaccine due to a small number of very rare but dangerous blood clots. Out of approximately 17 million people in the United States who have gotten the J&J vaccine, there have been nine deaths from the condition called thrombosis with thrombocytopenia, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices said Thursday. The CDC acted hours later, accepting the panel's recommendation. (Weise, 12/16)

The Wall Street Journal: CDC Recommends Pfizer, Moderna Covid-19 Vaccines Over J&J’s 
The updated position is likely to deal another blow to the use of the J&J shot, whose uptake had been hurt by manufacturing issues and earlier reports of J&J vaccine recipients, especially women, experiencing blood clots combined with low blood-platelet levels. There have been at least 54 cases of the condition, thrombosis with thrombocytopenia syndrome, or TTS, among J&J vaccine recipients in the U.S., including nine resulting in deaths, CDC officials said Thursday. (Loftus, 12/16)

NPR: CDC Narrows Use Of J&J Vaccine Amid Concerns About Blood Clots
In a statement, Johnson & Johnson said it "remains confident in the overall positive benefit-risk profile" of its vaccine. "The safety and well-being of those who use the Johnson & Johnson vaccine continues to be our number one priority," said Dr. Mathai Mammen, head of drug research and development at Johnson & Johnson, in the statement. "We appreciate today's discussion and look forward to working with the CDC on next steps." (Romo and Hensley, 12/16)

And the Novavax vaccine is 90.4% effective —

CIDRAP: Novavax COVID Vaccine Shows 90.4% Efficacy Against Infection 
A phase 3 trial yesterday in the New England Journal of Medicine (NEJM) finds that the Novavax COVID-19 vaccine is 90.4% effective against infection and 100% effective against moderate to severe illness, bringing yet another vaccine one step closer to approval. Novavax is a new adjuvanted, recombinant spike protein nanoparticle vaccine that has proven effective against COVID-19 infection in the United Kingdom and South Africa. This was the first such trial in North America. (Van Beusekom, 12/16)

Reuters: Novavax COVID-19 Vaccine Could Get EU Approval Next Week 
Novavax's COVID-19 vaccine could receive approval from Europe's drug regulator next week and subsequently an emergency use listing from the World Health Organization, the Financial Times reported on Thursday, sending shares of the U.S. drugmaker up 7%. A WHO approval could come once the health body issued its own emergency use listing or if the EMA gave it a conditional marketing authorization, the newspaper reported, citing people familiar with the matter. (12/16)

In updates on the Pfizer vaccine —

Reuters: Eight Heart Inflammation Cases Among Young Kids Who Got COVID-19 Shot - U.S. CDC
The U.S. Centers for Disease Control and Prevention said on Thursday it had received reports of eight cases of myocarditis, a type of heart inflammation, in children aged 5-11 years who received Pfizer and BioNTech's COVID-19 vaccine. The CDC had previously said that reporting rates of myocarditis for boys aged 16 to 17 could be more than 69 cases per million second doses administered and around 40 cases per million second doses in boys aged 12-15 years old. (12/16)

The Hill: Pfizer And BioNTech Seek Full Vaccine Approval For Those Ages 12-15 
Pfizer and BioNTech announced on Thursday evening that they had submitted an application to the Food and Drug Administration (FDA) seeking full approval for the administration of their two-dose COVID-19 vaccine in children aged between 12 and 15.The companies said in a release that their application included follow-up data from their Phase 3 clinical trial, which showed that two doses of the vaccine were 100 percent effective against COVID-19 among 12 to 15-year-olds. (Choi, 12/16)

CNN: Flu Vaccines Don't Match The Main Circulating Flu Virus Strain, Researchers Find
One of the main circulating influenza viruses has changed and the current flu vaccines don't match it well any more -- an indication they may not do much to prevent infection, researchers reported Thursday. But they are still likely to prevent severe illness. "From our lab-based studies it looks like a major mismatch," Scott Hensley, a professor of microbiology at the University of Pennsylvania who led the study, told CNN. It's bad news for the vaccine, he said. Influenza vaccines protect against four different strains of the flu: H3N2, H1N1 and two strains of influenza B. Hensley's study only covers H3N2, but that happens to be the main circulating strain. (Fox, 12/16)

The CDC's chart of past flu vaccines shows a so-so history of effectiveness:

CDC: Past Seasons' Vaccine Effectiveness Estimates
In the 2019-20 flu season, the adjusted overall effectiveness of the flu vaccine was just 39%. In the past 16 flu seasons listed on the CDC chart, the adjusted overall vaccine effectiveness has been as high as 60% and as low as 10%. (12/17)

In related news about the flu —

Post Crescent: After a year with almost no flu in Wisconsin, it's back — and fewer people are getting the shot
Tom Haupt, the state's influenza surveillance coordinator, told USA TODAY NETWORK-Wisconsin the surge in flu cases, especially among college students, has been "remarkable." He pointed to an early November outbreak at the University of Michigan, where over 300 cases were diagnosed in a single week, prompting the Centers for Disease Control and Prevention to investigate.  Wisconsin's flu vaccination rate, which has never topped 50%, is also lower this time than last year, according to the surveillance report. (Heim, 12/16)

Very Well Health: When Should You Get Tested For The Flu?
Peter Chin-Hong, MD, professor of infectious diseases at University of California, San Francisco, recommends taking a flu test if you tested negative for COVID-19. While uncommon, it’s possible to be infected with both COVID-19 and flu at the same time. “I think a lot of people are stuck in limbo land with symptoms,” Chin-Hong told Verywell. “You keep doing a million BinaxNOW assays just because you want to convince yourself that you don't have COVID.” (Bugos, 12/14)

Fox News: Biden Warns Of 'Winter Of Severe Illness And Death' For The Unvaccinated
President Biden said Thursday that Americans unvaccinated against the coronavirus are facing a winter of "severe illness and death." "It’s here now and it’s spreading and it’s going to increase," the president said about the omicron variant while meeting with his coronavirus response team. "For unvaccinated we are looking at a winter of severe illness and death if you’re unvaccinated for themselves, their families, and the hospitals they will soon overwhelm." "But, there’s good news," Biden added. "If you’re vaccinated and have your booster shot you’re protected from severe illness and death." (Mark Miller, 12/16)

CNBC: Fauci Says Omicron Will Become Dominant Covid Variant Soon, Urges Booster Shots
Dr. Anthony Fauci, President Joe Biden’s top medical advisor, said Thursday that omicron will become the dominant Covid-19 variant in the United States within a few weeks, urging people to get vaccines and booster shots to fight it off. “It is the most transmissible virus of Covid that we had to deal with those far. It will soon become dominant here. That’s one thing we know,” Fauci told a virtual U.S. Chamber of Commerce Foundation audience. (Macias, 12/16)

And a new, small study has more bad news about omicron —

Reuters: Small S.Africa Patient Study Shows Omicron Breaking Through Booster Shots 
A small study of seven COVID-19 cases in South Africa shows the Omicron variant can break through booster vaccine shots, one of the scientists involved said on Thursday. A group of seven German visitors to Cape Town, aged between 25 and 39, were infected at some point in late November or early December with confirmed cases of the Omicron coronavirus variant. ... None had reported past infection with COVID-19. The infections occurred between one and two months after receipt of the booster shot. (Cocks, 12/16)

In other news about the spread of omicron —

CNN: A Covid-19 'Viral Blizzard' Is About To Hit The US, Expert Says 
With Covid-19 hospitalizations rising as the holiday season gets into full swing, experts are urging people to take precautionary measures against a new variant that may quickly sweep the nation. While the Delta variant is still a worrying presence, there could be millions of more Americans infected within weeks due to the high transmissibility of the Omicron variant, said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. (Caldwell, 12/17)

The Washington Post: Omicron Surge Gives Many Americans Whiplash 
With the number of omicron cases appearing to double every two days, confirmed U.S. coronavirus infections have increased more than 50 percent in roughly two weeks, from 81,900 on Nov. 30 to 124,110 on Dec. 16, according to The Washington Post’s rolling seven-day average. After a briefing on the omicron variant from his coronavirus response team Thursday, President Biden warned that for unvaccinated Americans, “we are looking at a winter of severe illness and death.” He added: “Omicron is here. It’s going to start to spread much more rapidly at the beginning of the year, and the only real protection is to get your shots.” (Pager and Diamond, 12/16)

AP: With Omicron In 'Full Force,' NYC To Hand Out Masks, Tests
Alarmed by a rapid rise in COVID-19 cases and the increasing prevalence of the omicron variant, New York City officials will distribute one million masks and 500,000 home tests, Mayor Bill de Blasio said Thursday. The mass distributions are part of a broader plan to counter the virus’ spread that also includes making testing more easily available through more sites and extended hours. The state’s governor also said an online site would be set up where residents could ask for at-home tests to be sent to them, in targeted ways. (12/16)

Houston Chronicle: Houston Sees Early Signs Of New Omicron-Fueled COVID Wave As Texas Medical Center Cases Triple
Houston is seeing early signs of another wave of COVID-19 infections, fueled in part by a fast-spreading omicron variant, as public health officials warn of a nationwide spike in cases as early as next month. The daily average of positive cases in the Texas Medical Center more than tripled last week, from 232 to 721, and Houston Methodist on Tuesday recorded nearly five times the number of positive cases in its system compared to the previous week. Harris County Public Health on Tuesday reported 483 new cases, the highest single-day total in more than two months. (Gill, 12/16)

Los Angeles Times: Omicron Cases Jump In L.A. County As Experts Warn Of Rapid Spread - Los Angeles Times
The number of Omicron cases in Los Angeles County rose to at least 30, officials said Thursday has they continued to urge vaccinations and booster shots to slow the spread. Officials confirmed 12 new cases Thursday, saying the spread will likely intensify in the coming weeks. Of the 30 total Omicron cases in L.A. County, 24 people were fully vaccinated and four had also received booster doses. None have been known to be hospitalized, and none have died. (Lin II, 12/16)

KHN: KHN’s ‘What The Health?’: Oh, Oh, Omicron 
This week, the U.S. passed the milestone of 800,000 dead from covid-19, as hospitals are starting to fill following the Thanksgiving holiday and the ominous omicron variant starts to spread rapidly. Meanwhile, the Supreme Court signals it’s likely to roll back abortion rights in the next year, and Congress runs out of time to pass President Joe Biden’s Build Back Better bill in 2021. (12/16)

Also —

CNBC: Omicron Symptoms: Cold, Runny Nose, Headache, London Cases Shows
Symptoms associated with the Covid-19 omicron variant could be similar to those that normally accompany a cold, but experts are warning people that they should not underestimate the risks posed by the more transmissible strain. One British study has now suggested that omicron infections could be associated with symptoms that make it easy to mistake it for an everyday illness like a cold. The Zoe Covid Study, which analyzes thousands of Covid symptoms uploaded to an app by the British public, looked this week at symptoms associated with Covid cases in London that were recorded over two separate weeks in October and December, that is, before (as far as we know) and after omicron was spreading in the capital. (Ellyatt, 12/16)

The Boston Globe: Amid Surge In Patients, Hospitals Treat More People At Home
When Eleni Nicolau became sick with COVID after Thanksgiving, a breakthrough infection that hit the 83-year-old hard, she found herself alone in a hospital room, separated from her family and struggling to breathe. Then doctors gave her a new option: Did she want to finish her hospitalization at home? An ambulance brought Nicolau to the triple-decker where she lives in Worcester, and where for the next five days, nurses gave her oxygen, steroids, and antiviral drugs. Doctors talked to her on daily video calls. A biosensor on her arm tracked her vital signs around the clock. ”Everything you would have in the hospital, my mom had here,” said her daughter, Fran, who helped care for her. (Dayal McCluskey, 12/16)

Crain's Detroit Business: Henry Ford Health Hospitals, At Or Near Capacity, Delay Surgeries
Henry Ford Health System's hospitals have had to delay or relocate non-urgent surgeries to manage the increase in COVID-19 hospitalizations, which its executives describe as a crisis. All of the Detroit-based system's hospitals are near or at capacity and the situation is dire, executives reported in a news conference Wednesday morning. The news follows a similar announcement last week from Michigan Medicine in Ann Arbor. (Frank, 12/16)

AP: Rural Arizona Hospitals Seek Feds Help For COVID Staffing
Arizona is committing millions of dollars and asking the federal government for extra help as hospitals face a growing strain from rising COVID-19 caseloads and warn they are nearing their limits. Gov. Doug Ducey earmarked another $35 million aimed at helping hospitals staff their existing beds and discharge patients more quickly. His administration also asked the Federal Emergency Management Agency for 133 people to bolster staffing at seven rural hospitals. (12/16)

Axios: Weight Of COVID Pushing Health Care Workforce To Breaking Point 
New waves of COVID infections are crashing into a health care system whose workers are at a breaking point — if not already past it. Hospital workers have had little relief from COVID over the past two years. And that burned-out, dispirited workforce is again being overwhelmed by surges from Delta, while facing the specter of yet another wave from Omicron. (Reed, 12/17)

KHN: As Hospitals Fill Up, Paramedics Spend More Time Moving Patients, Less On Emergencies
The night after Thanksgiving, a small ambulance service that covers a huge swath of southwestern Colorado got a call that a patient needed an emergency transfer from the hospital in Gunnison to a larger one with an intensive care unit 65 miles away in Montrose. The patient — a 78-year-old man — was experiencing atrial fibrillation, an irregular heartbeat that usually isn’t life-threatening. But for patients like this one with chronic health conditions, a history of cardiac issues and high blood pressure, the condition can cause a stroke or heart failure. (Santoro, 12/17)

In other news about the spread of covid —

AP: COVID-19 Fears Dash Hopes For The Holiday Season -- Again
Lines again stretch around blocks at some COVID-19 testing sites. Refrigerated mobile morgues are on order, and parts of Europe are re-tightening borders amid a winter spike in coronavirus infections. This year’s holiday season was supposed to be a do-over for last year’s subdued celebrations. Instead it’s turning into a redux of restrictions, cancellations and rising angst over the never-ending pandemic. “This year, more than ever, everyone needed a holiday,” said John McNulty, owner of Thief, a Brooklyn bar that had to close for a day earlier this week because of an infected employee. (Rubinkam, Peltz and Swenson, 12/17)

Cincinnati Enquirer: With Christmas and Kwanzaa near and COVID-19 a risk, we ask, 'Would you do this, doc?'
The countdown has reached single digits until Christmas arrives and Kwanzaa commences, and there's only so much you can get done. You can go last-minute shopping, prepare feasts and plan gatherings for families and friends, get the kids to see Santa, and hit up that office party. You can, with luck anyway. But with omicron around and the delta variant still in the air, the question may be, should you? (Demio, 12/17)

Bloomberg: NYC Mayor-Elect Adams Plans New Steps In Covid Response
Eric Adams isn’t mayor yet. But New York City’s mayor-elect plans to make changes to the city’s Covid-19 response when he takes over City Hall on Jan. 1. In reaction to the rapid rise in Covid cases and hospitalizations in the city this week, the mayor-in-waiting pledged to create a new color-coded warning system to alert New Yorkers to the Covid threat level. He said the introduction of the omicron variant and the fast spike in Covid around the holidays would require some changes once he came to office. (Nahmias, 12/16)

USA Today: Dave Ramsey Sued For Religious Discrimination Over COVID Strategy
Personal finance guru Dave Ramsey required employees at his company to disregard COVID-19 work-from-home orders and attend in-person gatherings of more than 900 workers who were encouraged not to wear masks or maintain social distance, a new federal workplace discrimination lawsuit asserts. Employees at Ramsey Solutions – the Franklin, Tennessee, headquarters for the evangelical Christian bestselling author and media mogul – who wanted to work from home instead of coming to office were guilty of "weakness of spirit," Ramsey said, according to the lawsuit. (Snider, 12/16)

The Hill: Florida Man Kicked Off United Flight For Using Underwear As Mask In Protest 
A Florida man was kicked off a United flight for using a thong as a mask to protest the airline's mask mandate. The passenger, Adam Jenne, told local news outlet NBC2 that he believes he was in compliance with the airline's mask mandate, as the thong covered both his nose and mouth on the Dec 15. flight between Ft. Lauderdale and Washington, D.C. Airline staff, however, disagreed — and removed him from the flight.  (Raik, 12/16)

The New York Times: Affordable Coronavirus Tests Are Out There, if You Look
Your ability to find free tests may depend on where you live and work — and how much time and effort you’re willing to devote. Last week, for instance, Vermont issued its own mandate requiring insurers to cover the cost of at-home tests. The rule is retroactive and will apply to all tests purchased on Dec. 1 or after. Other states may ultimately issue similar rules — another reason to save your receipts. In addition, some employers offer free tests for employees on-site, supply free rapid tests to take home or provide health plans that cover the cost of at-home testing. (Anthes, 12/16)

WUSF Public Media: A Severe Case Of COVID Significantly Raises Death Risk In Following Year, UF Study Shows 
New research shows that people who are hospitalized with severe illness due to COVID-19 are more than twice as likely to die in the following year compared to people who did not contract the virus. In this conversation, the study's lead author, Arch Mainous, a professor of medicine at the University of Florida, says the research points to the need for vaccination to prevent people from getting severe COVID-19 in the first place. (Sheridan, 12/16)

NPR: COVID Can Lead To Lasting Harm To The Brain, Scientists Find
Months after a bout with COVID-19, many people are still struggling with memory problems, mental fog and mood changes. One reason is that the disease can cause long-term harm to the brain. "A lot of people are suffering," says Jennifer Frontera, a neurology professor at the NYU Grossman School of Medicine. Frontera led a study that found that more than 13% of hospitalized COVID-19 patients had developed a new neurological disorder soon after being infected. A follow-up study found that six months later, about half of the patients in that group who survived were still experiencing cognitive problems. (Hamilton, 12/16)

On  antibody research —

Reuters: AstraZeneca Antibody Cocktail Works Against Omicron In Study 
AstraZeneca said on Thursday a lab-study of its COVID-19 antibody cocktail, Evusheld, found that the treatment retained neutralising activity against the Omicron coronavirus variant, showing promise for wider use of the therapy. The study was conducted by independent investigators of the U.S. Food and Drug Administration, the company said, adding that more analyses of Evusheld against Omicron are being conducted by AstraZeneca and third-parties, with data expected "very soon." (12/16)

The Washington Post: Regeneron, AstraZeneca Give Mixed Results On Their Covid Antibody Cocktails Against Omicron 
Regeneron Pharmaceuticals and AstraZeneca, makers of monoclonal antibody cocktails used as treatment for many coronavirus patients who have not been vaccinated, announced contrasting data Thursday about the potency of their covid-19 therapies against the omicron variant. Regeneron, which warned earlier this month that its antibody treatment may not be as effective against the new variant, said data confirms it has “diminished potency” against omicron but remains useful against delta. ... AstraZeneca, however, said that a lab study of Evusheld, the company’s coronavirus antibody cocktail, found that the treatment “retained neutralizing activity” against omicron. (Bella, 12/16)

CNBC: Regeneron Developing Antibodies To Target Omicron As Current Cocktail Loses Potency Against Variant
Regeneron Pharmaceuticals is developing new antibodies that work against the omicron variant of Covid-19, after the company confirmed that its current cocktail has diminished potency against the heavily mutated strain. CEO Leonard Schleifer told CNBC on Thursday that Regeneron plans to conduct trials on the new antibodies in the first quarter of 2022. Schleifer said Regeneron is working with the Food and Drug Administration to get the next generation of antibodies approved as efficiently as possible. (Kimball, 12/16)

The Washington Post: As The Omicron Variant Threatens To Wipe Out Monoclonal Antibodies, The U.S. Is Saving Up One That Will Still Work
With the omicron variant of the coronavirus poised to thwart most covid-19 treatments, U.S. public health officials are stockpiling the one monoclonal antibody that remains effective so that it can be deployed when the variant becomes more prevalent. Omicron represents an estimated 3 percent of coronavirus cases in the United States, but in some states it is estimated to make up 13 percent of all cases, Rochelle Walensky, director of the Centers for Disease Control and Prevention, said Wednesday. Some hospitals are reporting even more concerning figures: At Houston Methodist, omicron grew from 13 percent of cases to more than 30 percent in four days. In New York, the percent of positive tests doubled in three days — a key sign of accelerating spread. (Johnson, 12/16)

Milkwaukee Journal Sentinel: Shark Antibodies May Prove Effective Against COVID-19
Nurse sharks gliding around a tank at the University of Wisconsin-Madison may hold the secret to an unusual, previously unexamined treatment for COVID-19, according to a new study published Thursday in the journal Nature Communications. Antibodies derived from the immune systems of sharks proved effective against the new coronavirus, including the Delta variant, in lab experiments using human lung and embryonic kidney cells. (Johnson, 12/16)

Also —

Axios: How The Little-Known B And T Cells Can Protect Against COVID Variants 
The body's long-term immune responses help to defend against emerging coronavirus variants even as antibody immunity is waning in people who are vaccinated or who've had prior COVID-19 infections. Variants are testing the success of the COVID-19 vaccines, as antibody levels typically drop after peaking from infection or vaccination. (Drage O'Reilly, 12/16)

AP: Courts Keep Chipping Away At Biden COVID-19 Vaccine Mandates
Federal judges in Louisiana and Texas continue to chip away at Biden administration COVID-19 vaccine mandates. The latest of the piecemeal blows to the vaccine mandates came Thursday in lawsuit filed by Louisiana, Indiana and Mississippi. In that case, U.S. District Judge Dee Drell in Alexandria, Louisiana, declined to block a requirement that all employees of federal contractors get vaccinated — noting that there is already a nationwide block on that mandate issued by a Georgia-based federal judge. (McGill, 12/17)

AP: Justice Department Asks High Court To Allow Vaccine Mandate 
The Biden administration late Thursday asked the Supreme Court to block lower court orders that are keeping President Joe Biden’s vaccine mandate for health care workers from going into effect in about half of the states. The administration asked the justices to allow the “urgently needed health and safety measure to take effect before the winter spike in COVID-19 cases worsens further.” It said the requirement “will save hundreds or even thousands of lives each month.” (12/17)

AP: EXPLAINER: Must Employers Follow Biden's Vaccine Mandates?
The Biden administration contends its rule-making authority is firm and supersedes any state policies prohibiting vaccine requirements. Recent experience shows that such mandates generally prompt people to get vaccinated: By the time a Biden requirement for federal workers to be vaccinated took effect last month, 92% had received at least their first dose of the shot. Following is a rundown of some of Biden’s most sweeping vaccine requirements and the status of the legal fights over them. (Lieb and Mulvihill, 12/17)

And more members of the U.S. military are dismissed for not getting vaxxed —

Politico: More Than 100 Marines Kicked Out Of The Service For Refusing Covid Vaccine 
The Marine Corps has booted 103 of its members for refusing the Covid vaccine, the service announced on Thursday, even as all the military branches report that a vast majority of troops have gotten the shots. The news comes the same day the Army announced that it has relieved six leaders — including two commanding officers — over the issue, and that almost 4,000 active-duty soldiers have refused the vaccine. (McLeary, 12/16)

The New York Times: Vaccine Holdouts In Army And Navy Will Be Dismissed, Military Says 
The vast majority of active-duty troops in the Army and the Navy are vaccinated against the coronavirus, and the small number of those still refusing shots will soon be dismissed from the military, officials said on Thursday. In the Army, 468,459 active-duty soldiers, or 98 percent, have received at least one dose of the vaccine. The Navy has inoculated 342,974 members, with roughly 1.7 percent still holding out. (Steinhauer, 12/16)

In related news from Vermont —

Burlington Free Press: Most of the Vermont National Guard Is Vaccinated. Here's What Happens to the Unvaccinated.
The majority of Vermont's Air and Army National Guard members have been vaccinated according to numbers released by the Guard on Wednesday. There are still some, however, who remain unvaccinated. Between the Air and Army branches of the National Guard, there are two deadlines for troops to be fully vaccinated. For the Vermont Air National Guard, airmen had to be vaccinated by Dec. 2 and 93% of the force is currently fully vaccinated. Vermont Army National Guard's deadline isn't until the end of June 2022, and so far 85% soldiers have been vaccinated. Active-duty Army soldiers were required to be fully vaccinated Dec. 15, but this does not apply to most Vermont Army National Guard soldiers, only those that are currently deployed. (St. Angelo, 12/17)

The Hill: University Of Maryland Cancels Winter Commencement Amid Surge In COVID-19 Cases
The University of Maryland has canceled its winter commencement after recording over 100 new positive COVID-19 cases on campus. "With a heavy heart, we are canceling all winter commencement activities," the school said on Thursday. "This decision was not made lightly. We know how important this time is for our winter graduates and their families, but our first responsibility must continue to be the health and well-being of our community." (Beals, 12/16)

In other higher-education news —

Atlanta Journal-Constitution: Emory University In Atlanta Mandates COVID Booster Shots For Students
Emory University announced Thursday that it will require all employees, faculty and students to get a COVID-19 booster shot within the next month. Emory, the state’s largest private university, has become one of the biggest schools in Georgia to order booster shots. It has more than 32,000 employees and about 15,000 students. President Gregory Fenves said in a letter the university is requiring the shots because of the increased spread of COVID-19 nationwide and the emerging omicron variant. (Stirgus, 12/16)

San Francisco Chronicle: As Omicron Looms, Stanford Requires Boosters For Students, Moves Classes Online In Early January
Stanford University is moving classes online for the first two weeks of the winter quarter and requiring all eligible students to get a booster shot by the end of January, according to an email sent to the campus community Thursday. Stanford officials said online classes will start Jan. 3 and in-person instruction will resume Jan. 18, after the Martin Luther King Jr. holiday. Students can still return to campus as planned, even though they will be learning online initially. Parties and similar gatherings are banned during the first two weeks of the winter quarter. (Morris, 12/16)

Atlanta Journal-Constitution: Morehouse School Of Medicine Delays $6,300 COVID Grants To Students
Morehouse School of Medicine administrators say the $6,300 grants it would give students this week will be delayed as federal education department officials review the plans. The school’s president, Dr. Valerie Montgomery Rice, announced the delay in a letter Tuesday to students. The letter also says some students, such as those who don’t have children and aren’t caregivers for their own parents, may receive $4,800 instead of $6,300. The 754-student school, located near downtown Atlanta, said earlier this month it planned to provide grants from federal coronavirus aid to help students with ongoing pandemic costs such as child care, health care, housing and transportation. (Stirgus, 12/15)

In updates about K-12 schools —

The Daily Beast: Missouri, D.C,, Maryland, New York City Schools Close Early Over Coronavirus As Omicron Surges
As states scramble to contain a fresh surge of COVID-19 cases that may only worsen with the holiday season and the emergence of the Omicron variant, schools are once again shutting their doors to curtail the spread of the deadly disease. In Maryland, at least three schools announced they were closing their doors early after reporting a COVID-19 outbreak, while several schools in the District of Columbia area have also moved to online learning to contain an ongoing outbreak. A few states away, in New York City, the Department of Education has shuttered over 800 classrooms amid a mass surge of COVID-19 cases in the area. (Melendez, 12/16)

Detroit Free Press: Detroit Schools Approve COVID-19 Vaccine Mandate For Staff Members
All Detroit school teachers and staff members must be fully vaccinated by Feb. 18 under a new mandate approved by the district's school board on Thursday. Detroit Public Schools Community District officials said the mandate will impact a very small percentage of staff members who have yet to be vaccinated. The new requirement will require employees in the largest district in the state to receive the vaccine and report their status to the district by Feb. 18. (Altavena, 12/16)

New Orleans Times-Picayune: New Orleans Expands Indoor And School Vaccine Mandate To Children Ages 5 And Up, A First In The U.S.
In response to increasing COVID-19 cases and the rise of a more infectious variant as the holidays and Carnival approach, Mayor LaToya Cantrell expanded New Orleans' indoor vaccine or negative test requirement Thursday to children ages 5 to 11 and the New Orleans public school system mandated vaccination for students age 5 and older. The indoor mandate will go into effect Jan. 3, when children will be required to show proof of at least one vaccine dose. On Feb. 1, four weeks before Mardi Gras, the requirement will be two doses. The school requirement goes into effect Feb. 1, Superintendent Henderson Lewis Jr. said. (Woodruff, 12/16)

The Washington Post: NFL Makes Major Protocol Change, While Players’ Union Advocates For Postponements 
The NFL made a significant change Thursday to its coronavirus protocols, allowing a vaccinated player who tests positive for the virus but has no symptoms to test out of isolation in as little as one day. Meanwhile, the players’ union was advocating for the league to consider postponing games involving teams with large numbers of cases. The NFL Players Association believes that “rescheduling games should be an option” related to “any teams with major outbreaks,” according to a person familiar with the NFLPA’s view. (Maske, 12/16)

AP: NBA, Players Agree To Additional Protocols Through Holidays
The NBA and its players have agreed to enhanced health and safety protocols through the holiday season in response to rising virus numbers, with additional testing coming and a return to mask usage in many situations. The upgraded mask rules will be in place “until agreed otherwise by the NBA and Players Association,” according to a memo shared with teams Thursday night and obtained by The Associated Press. Masks need to be worn again in almost all circumstances during team activities — including travel, when on the bench during games, in meetings and locker room, weight room and training room settings. The exceptions: during on-court basketball activities for players, and for head coaches during games. (Reynolds, 12/16)

The Washington Post: Why Asymptomatic, Positive Athletes Still Need To Sit Out
Among the rash of players unavailable to play after testing positive, the vast majority are vaccinated and many are asymptomatic. So in a time of widely available vaccines and booster shots, would it be safe for sports leagues to allow vaccinated, asymptomatic players who test positive for the coronavirus to play in games? That day may come, public health experts say, with improved testing capability allowing players to safely return to play sooner, but it is not here yet. (Kilgore, 12/16)

And in news about ALS and CTE among professional athletes —

NPR: NFL Players Are Four Times More Likely To Develop ALS, A New Study Shows
Professional football players in the NFL are four times more likely to develop and die from ALS than the adult male population, according to new research. Scientists at Boston University's CTE Center, who conducted the study released Wednesday, said they couldn't determine exactly why the rate was higher for those athletes but suggested that repetitive head impacts and traumatic brain injuries may play a role. Amyotrophic lateral sclerosis, also known as Lou Gehrig's disease, is a fatal neurodegenerative disease with no known cure. ALS has been linked to chronic traumatic encephalopathy, or CTE, another degenerative brain disease found in many former football players. (Hernandez, 12/16)

The Washington Post: Vincent Jackson, Ex-NFL Player Found Dead In February, Had CTE 
The family of Vincent Jackson, a former NFL wide receiver who was found dead in February at age 38, announced Thursday that he was diagnosed with chronic traumatic encephalopathy (CTE) after a brain study conducted by researchers from the Concussion Legacy Foundation. According to the foundation, Jackson was in Stage 2 of the disease, which is “associated with behavioral symptoms like aggression, impulsivity, depression, anxiety, paranoia, substance abuse, and suicidal ideation, along with progressive cognitive symptoms.” (Bieler, 12/16)

The New York Times: Vincent Jackson’s Widow Hopes Speaking About His C.T.E. Warning Signs Will Help Others 
The C.T.E. diagnosis will provide only a partial coda for Lindsey Jackson and their four children. Though the family has come to grips with his absence in the 10 months since his death, many questions will never be answered. C.T.E. can only be diagnosed posthumously, so the Jacksons are left to piece together what was going on in his brain during the final years of his life. ... “When I look back at the different conversations we’ve had, I feel like he probably knew that there was something going on without actually vocalizing it,” Lindsey Jackson said. (Belson, 12/16)

Stat: Judge Reverses $4.5 Billion Purdue Pharma Bankruptcy Settlement 
A federal court judge has reversed the hotly contested Purdue Pharma bankruptcy plan after deciding a bankruptcy judge did not have authority to grant immunity to the Sackler family members who control the controversial drug maker. A provision in the plan grants immunity to some of the Sacklers as well as hundreds of their associates from future lawsuits, even though — unlike Purdue — they did not file for bankruptcy protection. The Sackler family members had insisted that a bankruptcy deal would not be possible, though, unless they were released from all future liability related to the harm caused by Purdue’s OxyContin painkiller. (Silverman, 12/16)

Bloomberg: Purdue Pharma Appeals Judge Strikes Down Opioid Settlement
In her ruling, U.S. District Judge Colleen McMahon said the bankruptcy court lacked authority to grant the kind of releases at issue. So-called third party releases have divided federal courts across the country for decades, she said, adding that her ruling won’t be the last word on the subject. “This issue has hovered over bankruptcy law for thirty-five years,” McMahon said in her written ruling. “It must be put to rest sometime; at least in this Circuit, it should be put to rest now.” (Hill, 12/16)

AP: Judge Rejects Purdue Pharma’s Sweeping Opioid Settlement
In a statement Thursday night, the company said that it would appeal the ruling and at the same time try to forge another plan that its creditors will agree to. Purdue said the ruling will not hurt the company’s operations, but it will make it harder for company and Sackler money to be used to fight the opioid crisis as the legal fight continues. “It will delay, and perhaps end, the ability of creditors, communities, and individuals to receive billions in value to abate the opioid crisis,” said Steve Miller, chairman of the Purdue board of directors. (Mulvihill, 12/17)

The Washington Post: Purdue Pharma Deal Giving Sackler Family Civil Immunity From Opioid Claims Overturned
Attorney General Merrick Garland said the Justice Department was pleased with Thursday’s ruling, saying in a statement that “the bankruptcy court did not have the authority to deprive victims of the opioid crisis of their right to sue the Sackler family. ”Representatives of the two branches of the family who own the company did not immediately respond to a request for comment. The third branch, descendants of Arthur Sackler, was not involved in the litigation — he sold his shares of the company before OxyContin’s introduction. (Kornfield, 12/16)

In related news about the opioid crisis —

NPR: They didn't plan to be a family of 17. Then, the opioid crisis hit their community
When opioid addiction began to ravage Suzanne and Jesus Valle's Ohio community more than two decades ago, the husband and wife saw another crisis unfolding. In Blue Creek, Ohio, one of the hardest hit areas in the country's opioid epidemic, children whose parents had become addicted to pain pills, heroin and other opioids were becoming the invisible casualties of the crisis. So, the Valles stepped in to help. From 2007 to 2018, they had taken in six children, all from Ohio families struggling with addiction, including their own. (Corona, Esty-Kendall and Bowman, 12/17)

The Wall Street Journal: Fentanyl Invades More Illicit Pills, With Deadly Consequences 
Zachary Didier took what looked like a prescription pain pill just after Christmas last year, according to his parents. It contained an illicit form of the powerful opioid fentanyl, which they say killed the 17-year-old Californian. His death was one of a record 100,000 fatal overdoses in a year-long period through April that have demonstrated how the nation’s illegal drug supply is becoming more toxic and dangerous. A bootleg version of fentanyl being made mainly by Mexican drug cartels is spreading to more corners of the U.S., increasingly inside fake pills taken by people who in some cases believe they are consuming less-potent drugs. (Kamp and Wernau, 12/16)

The Wall Street Journal: Oracle In Talks To Buy Cerner 
Oracle Corp. is in talks to buy electronic-medical-records company Cerner Corp., according to people familiar with the matter, a deal that could be worth around $30 billion and push the enterprise-software giant further into healthcare. An agreement could be finalized soon, some of the people said, assuming the talks don’t fall apart or drag out. Should a deal come together, it would rank as the biggest ever for Oracle, which has a market value of more than $280 billion. (Lombardo and Cimilluca, 12/16)

In other health care industry news —

Modern Healthcare: OSHA's COVID-19 Prevention Standard Could Lapse Within Days
The Occupational Safety and Health Administration has less than a week to extend its emergency temporary standard on COVID-19 prevention for healthcare facilities but hasn't yet moved to make the policy permanent, and stakeholders aren't sure what happens next. Emergency temporary standards from OSHA are supposed to be finalized within six months of their release. Policies stay in effect until replaced by a final action, an OSHA spokesperson wrote in an email. The spokesperson wouldn't say whether failing to extend the current standard would count as a final action. The standard is set to expire Dec. 21 unless OSHA issues a final rule. (Goldman, 12/15)

Axios: Scoop: Prospect Medical Seeks Multiple Buyers 
Prospect Medical Holdings, after buying back Leonard Green & Partners' stake this summer, is seeking suitors for its West and East Coast assets, sources familiar with the matter told Axios. These assets come to market when buyers are eager to invest behind the health-care industry's transition to value- or risk-based care and some of these assets could provide an opportunity to do just that. (Pringle, 12/16)

Modern Healthcare: Acadia, Fairview To Open Twin Cities Hospital
Acadia Healthcare has inked yet another joint venture with a not-for-profit health system, this time partnering with Fairview Health Services to open a new hospital in Minnesota. The for-profit health system and Fairview Health Services will design and build an inpatient mental health and addiction treatment facility serving the Minneapolis and St. Paul area, Franklin, Tennessee-based Acadia Healthcare announced Thursday. The partners expect to spend $50 million on the new hospital. (Bannow, 12/16)

AP: Ex-California Doctor Convicted In Weight-Loss Insurance Scam 
A former Southern California doctor was convicted Thursday of falsely billing military and private insurers $355 million for weight-loss surgeries. Julian Omidi, 53, of West Hollywood and his Beverly Hills-based company, Surgery Center Management LLC, were convicted by a federal jury of three dozen counts of wire and mail fraud, money laundering, conspiracy and making false statements related to health care matters, according to a statement from the U.S. attorney’s office. A second physician, Dr. Mirali Zarrabi, 59, of Beverly Hills, was acquitted of all charges, prosecutors said. (12/17)

KHN: ‘The Charges Seem Crazy’: Hospitals Impose A ‘Facility Fee’ — For A Video Visit 
When Arielle Harrison’s 9-year-old needed to see a pediatric specialist at Yale New Haven Health System in June, a telehealth visit seemed like a great option. Since her son wasn’t yet eligible to be vaccinated against covid-19, they could connect with the doctor via video and avoid venturing into a germy medical facility. Days before the appointment, she got a notice from the hospital informing her that she would receive two bills for the visit. One would be for the doctor’s services. The second would be for a hospital facility fee, even though she and her son would be at home in Cheshire, Connecticut, and never set foot in any hospital-affiliated building. (Andrews, 12/17)

The Wall Street Journal: The Elizabeth Holmes Trial: Prosecution Gets Final Chance To Sway Jurors 
Prosecutors in Elizabeth Holmes’s criminal-fraud trial made their case one more time in closing arguments Thursday as jurors move closer to deciding the fate of the Theranos Inc. founder. Assistant U.S. Attorney Jeffrey Schenk gave jurors a summation of the government’s case against Ms. Holmes, arguing she knowingly and willfully lied about Theranos’s technology to salvage her startup as it quickly ran low on money. (Somerville, 12/16)

AP: Elizabeth Holmes Jurors Hear Different Takes On Her Downfall
Jurors in the case of former Theranos CEO Elizabeth Holmes on Thursday heard starkly different interpretations of her motives and actions as her long-running criminal trial nears the finish line. A federal prosecutor cast Holmes as a desperate con artist who brazenly lied to get rich, while her lawyer depicted her as a well-meaning entrepreneur who never stopped trying to perfect Theranos’ blood-testing technology and deliver on her pledge to improve health care. (Liedtke, 12/17)

The Washington Post: The Fortune Cover Made Elizabeth Holmes A Star And Might Send Her To Prison. 
The story was 5,500 words of pure rapture about a Silicon Valley company few had ever heard of and its intriguing chief executive. Theranos, declared Fortune magazine in 2014, appeared to be on the verge of revolutionizing the health care industry with a wondrous new technology for diagnosing diseases with just a few drops of blood. The magazine’s cover put a human face on the company’s alleged breakthroughs. Theranos’s founder, a young woman named Elizabeth Holmes, stared at readers with serene blue eyes and a Mona Lisa smile. “This CEO Is Out for Blood,” the headline read. (Farhi, 12/16)

In other pharmaceutical and biotech news —

Modern Healthcare: Provider Groups Call For Drug Supply Chain Restructuring To Avoid Shortages
The federal government should offer incentives to encourage drugmakers to manufacture critical medicines and active pharmaceutical ingredients, a coalition of provider organizations urge in a set of policy recommendations issued Thursday. Rewarding pharmaceutical suppliers for developing continuous manufacturing infrastructure in the U.S. and abroad could help mitigate drug shortages, the American Medical Association, American Society of Anesthesiologists, American Society of Health-System Pharmacists, Association for Clinical Oncology and United States Pharmacopeia urge in the report. (Kacik, 12/16)

Stat: FDA Rebukes Endo For 'Anticompetitive Practices' And Asks FTC To Investigate 
In an unusual move, the U.S. Food and Drug Administration has openly suggested that a brand-name drug maker attempted to delay competition after it petitioned the agency to reject generic versions of its biggest-selling medicine. As a result, the FDA plans to ask the U.S. Federal Trade Commission to investigate the company for “anticompetitive business practices.” (Silverman, 12/16)

Axios: Scoop: Amazon Pharmacy Leaders Demoted
Amazon Pharmacy leaders T.J. Parker and Elliot Cohen have quietly been demoted to roles as consultants for the company, two sources familiar with the matter tell Axios. The leadership shakeup could either be an attempt at hammering out a clearer path forward or a sign of deeper troubles. Parker and Cohen have steered Amazon Pharmacy since 2018 when the tech giant acquired PillPack, their prescription drug startup. (Brodwin, 12/16)

Stat: Prescription Apps To Treat Disease Face Uncertainty Over Coverage
In August, Pear Therapeutics, the company at the forefront of creating prescription software to treat health conditions, announced that it had landed a deal with Optum Rx, which administers pharmacy benefits for millions of people nationwide. It was a coup for an 8-year-old company, which had recently announced its intention to go public in a $1.6 billion deal, despite projecting just $4 million in revenue for 2021. According to the celebratory announcement, Pear’s three commercial smartphone apps, which deliver cognitive behavioral therapy for the treatment of substance use disorder, opioid use disorder, and insomnia, would have “formulary availability” with the country’s third-largest pharmacy benefits manager. (Aguilar, 12/17)

Modern Healthcare: CMS To Propose New Medicare 'Breakthrough' Device Rule In 2022
The rule might differ from the Trump administration's version of the policy by requiring more evidence collection on how effective a device is for Medicare beneficiaries, and it may give the Centers for Medicare and Medicaid Services more say in the coverage determination process, said Tom Bulleit, a partner at Ropes & Gray. CMS repealed a rule last month that would have allowed Medicare to immediately cover medical devices designated as "breakthrough technology" by the Food and Drug Administration for four years after they received market authorization. (Goldman, 12/16)

KHN: Seeking Refills: Aging Pharmacists Leave Drugstores Vacant In Rural America 
Ted Billinger Jr. liked to joke that he would work until he died. That turned out to be prophetic. When Billinger died of a heart attack in 2019 at age 71, he was still running Teddy B’s, the pharmacy his father had started more than 65 years earlier in Cheyenne Wells, Colorado. With no other pharmacist to work at the store, prescriptions already counted out and sealed in bottles were suddenly locked away in a pharmacy that no one could enter. And Cheyenne Wells’ fewer than 800 residents were abruptly left without a drugstore. Pharmacies were once routinely bequeathed from one generation to the next, but, in interviews with more than a dozen pharmacists, many said the pressure of running an independent drugstore have them pushing their offspring toward other careers. (Hawryluk, 12/17)

In research news —

Fox News: Advanced Gene Therapy May Reverse Hearing Loss Caused By Genetics: Study
Researchers at Boston Children’s Hospital found that replacing a mutated protein in the inner ear reversed severe hearing loss in mice, according to a study published in the journal Science Advances. The first-of-its-kind gene therapy technique involved replacing a mutated protein called stereocilin, (STRC), in the inner ear. The investigators said it reversed severe hearing loss in mice and in some cases, restored it to normal levels of hearing, according to a news release. The researchers explained in the release, that hearing loss has been associated with mutations of at least 100 different genes. The researchers stated that up to 16 percent of genetic hearing loss could be linked to the gene STRC, which they noted is also the second most common genetic cause. (McGorry, 12/16)

Stat: As Aduhelm Faces Doubts, Biogen Plans Another Pivotal Trial For 2022
Biogen said Thursday that it expects to begin a large clinical trial next May to confirm the benefits of the Alzheimer’s disease treatment Aduhelm, pending clearance from U.S. regulators. The trial, a condition of Aduhelm’s Food and Drug Administration approval, could answer some outstanding questions that have kept many neurologists from prescribing Biogen’s drug. But it’ll be years before the company has data to show. (Garde and Feuerstein, 12/16)

The Wall Street Journal: Navy Won’t Close Hawaii Jet-Fuel Facility That Leaked Into Locals’ Drinking Water
A U.S. Navy committee tasked with addressing a leak of jet fuel from a World War II-era storage facility that contaminated the water supply on a base in Hawaii won’t consider closing the site, a Navy official said. A Navy official familiar with the task-force plans said that Red Hill was a strategic asset too important to Pacific naval operations to close. ... “We are not looking to shut anything down,” the official said. “We are looking at what happened in the incident, and then will make informed decisions going forward about how to make sure we are providing a continued source of potable drinking water and keeping people safe.” (Youssef, 12/16)

In other news from across the U.S. —

The Center For Public Integrity: How Lack Of Medicaid Expansion Fuels Rural Poverty In The Deep South  
Jabriel Muhammad pays up to $40 when he sees a doctor at the community health center in Jefferson County in rural southwestern Mississippi, and he goes to the center only when he is really ill. But there’s another price to pay for not having health insurance. In October, he was hit with a $1,394 hospital bill for an MRI scan to diagnose why he wasn’t breathing properly. “We’re poor folks trying to make it as best we can,” said Muhammad, a 40-year-old self-employed carpenter and plumber. “If I make $10,000 with the work that I do in a year, that’s a nice feeling to me.” In Mississippi, the poorest and blackest state in the U.S., single adults without children like Muhammad are not eligible for public health insurance, regardless of how little they earn each year. If he lived 30 miles west in Louisiana, across the Mississippi River, he could afford to see a doctor more often. (Simpson, 12/16)

Anchorage Daily News: Dunleavy Administration Revives Proposal To Split Alaska’s Health And Social Services Department In Two
Alaska Gov. Mike Dunleavy’s administration plans again to pursue splitting the state health department into two after a similar proposal was withdrawn earlier this year for additional work. Dunleavy’s new budget proposal calls for breaking the current Department of Health and Social Services into a Department of Health and a Department of Family and Community Services. (Bohrer, 12/16)

USA TODAY: What's Next for Pot in New England in 2022? VT Sales Starting, MA Equity Issues and More.
In 2021, Massachusetts surpassed $2 billion in recreational sales for the industry's three years of operation. Connecticut legalized recreational use in June, becoming the 18th state in the country to do so, and laying the initial groundwork for its own future marketplace in late 2022. Maine's recreational sales topped $10 million in August of this year, a new record for the Pine Tree State since sales began in 2020. (Barndollar, 12/16)

In mental health news —

AP: New Resource Center To Address Child Behavioral Health Needs 
The University of New Hampshire’s Institute on Disability is going to develop a new resource center to address behavioral health needs of children up to age 21. “We have a wonderful opportunity to create a system of supports to respond to youth and families in crisis and to help them find hope so they can move on and live their best lives,” said JoAnne Malloy, research associate professor and co-director of the Children’s Behavioral Health Resource Center. (12/17)

Billings Gazette: Schools Says Fix For In-School Mental Health Services Is Unworkable
As the new system to handle paying for in-school mental health treatment for Montana students with serious emotional problems is “on the brink of being put into place,” school districts around the state say it’s not workable. The Comprehensive School and Community Treatment program connects licensed or supervised in-training practitioners from a mental health center and behavioral health aides with children who can get services at school, in their homes or in the community. (Michels, 12/16)

The New York Times: We Asked 1,320 Therapists What They’re Hearing From Patients
Frontline mental health workers in every state say they can’t keep up with the demand from patients struggling with the disruptions of pandemic life. (Parker-Pope, Caron and Cordero Sancho, 12/16)

The Wall Street Journal: Omicron’s Surge Is Changing The Rules Of Travel
Anyone hoping to comply with the latest Covid-related travel restrictions should start by assuming they are nothing like the ones in the city, state or country next door to their destination. Countries have been swift to impose new travel restrictions due to concerns about the Omicron variant. Each destination sets its own requirements, and the rules are far from consistent, which can cause extra stress and confusion for travelers. The confusion over Omicron is just one of many for travelers. (Pohle, 12/16)

The Wall Street Journal: Covid-19 Cancels Christmas Around Europe…Again 
Across Europe, tightening restrictions and new uncertainties are hitting an already virus-weary populace. In some German provinces, traditional Christmas markets have been closed and the country has banned firecrackers and big gatherings for New Year’s Eve. In Paris, the Élysée Palace canceled its holiday party while towns across the rest of France are calling off Christmas concerts. Cath Colbridge, 50, who works at a primary school in the South Wales village of Cefn Cribwr, said that she and her husband had to cancel their Christmas holiday to Spain after the hotel closed down. It was her sixth canceled holiday during the pandemic. “I’m so frustrated that they keep changing the travel rules,” Ms. Colbridge said. “It’s got to the point now that we’ve given up planning holidays abroad and bought a camper van, so we can at least get away for a few days.” (Kantchev and Dalton, 12/16)

AP: EU Leaders Urge Booster Shots, Seek Coordinated Travel Rules
European Union leaders agreed Thursday that administering booster shots is “urgent” and “crucial” to tackle the surge of coronavirus infections across the continent and the emergence of the new omicron variant. With the festive season looming, the bloc’s leaders also stressed the importance of coordinated action to avoid a confusing cacophony of rules in the 27 member states, and ensure that COVID-19 certificates continue to guarantee unrestricted travel. (Petrequin, 12/16)

In other global news —

CIDRAP: DRC'S 13th Ebola Outbreak Declared Over
The Democratic Republic of the Congo (DRC) today declared the end of its thirteenth Ebola outbreak, given that two 21-day incubation periods have passed since the last patient was discharged from treatment, the World Health Organization (WHO) African regional office said today. There were 11 cases, 8 of them confirmed and 3 probable, and 6 people died from their infections. The outbreak was declared on Oct 8 and was focused in North Kivu province's Beni health zone, which was one of the hot spots in the country's large 2018 outbreak. (12/16)

The Washington Post: The U.S. Built A Hospital For Iraqi Children With Cancer. Corruption Ravaged It
Basra’s Children’s Hospital was meant to be the best. After the United States invaded Iraq in 2003, first lady Laura Bush took a personal interest in its establishment as a world-class hospital for children with cancer, and the U.S. government spent more than $100 million toward its completion. Eighteen years later, the hospital is a casualty of an Iraqi health-care system so riddled with corruption and damaged by neglect that World Bank figures put it among the region’s worst. After decades of war and sanctions battered the medical sector, today an army of crooks is robbing Iraqis of their aspirations for a healthy life, acknowledge former and current Iraqi officials. (Loveluck and Salim, 12/16)

CIDRAP: Investigators Dig Deep To Solve Melioidosis Mystery
The mystery behind the outbreak began with the disease itself. Melioidosis is incredibly rare in the United States, with only 12 cases reported annually. And because the symptoms it causes—cough, shortness of breath, fatigue, nausea—are nonspecific, it's often confused with other respiratory ailments. (Dall, 12/13)

The New York Times: Why More Kids Aren’t Getting The HPV Vaccine
Vaccine hesitancy is hardly limited to shots against Covid-19. Even the HPV vaccine, which can prevent as many as 90 percent of six potentially lethal cancers, is meeting with rising resistance from parents who must give their approval before their adolescent children can receive it. The Food and Drug Administration licensed this lifesaving vaccine in 2006 to protect against sexually transmitted infection by HPV, the human papillomavirus. Most of us will get infected with HPV during our lifetimes, certain strains of which can lead to cancers of the cervix, vagina and vulva in women; cancers of the anus and back-of-the-throat in both women and men; and penile cancer in men. HPV can also cause genital warts. (Brody, 12/13)

The New York Times: Where The Despairing Log On, And Learn Ways To Die 
Most suicide websites are about prevention. This one — started in March 2018 by two shadowy figures calling themselves Marquis and Serge — provides explicit directions on how to die. ... Participants routinely nudge one another along as they share suicide plans, posting reassuring messages, thumbs-up and heart emojis, and praise for those who follow through: “brave,” “a legend,” “a hero.” (Twohey and Dance, 12/9)

The New York Times: How Exercise Affects Metabolism And Weight Loss
Many of us remember “The Biggest Loser,” the somewhat notorious reality television show that ran for more than a decade starting in 2004, in which contestants competed feverishly to drop massive amounts of weight over a short period of time. One of the biggest lessons of the show appeared to be that extreme exercise, along with draconian calorie restriction, would lead to enormous weight loss. ... Now a new scientific analysis of the show and its aftermath, published last month in the journal Obesity, suggests many beliefs about “The Biggest Loser” may be misconceptions. (Reynolds, 12/15)

The New York Times: On Syria’s Ruins, A Drug Empire Flourishes
Built on the ashes of 10 years of war in Syria, an illegal drug industry run by powerful associates and relatives of President Bashar al-Assad has grown into a multibillion-dollar operation, eclipsing Syria’s legal exports and turning the country into the world’s newest narcostate. Its flagship product is captagon, an illegal, addictive amphetamine popular in Saudi Arabia and other Arab states. Its operations stretch across Syria, including workshops that manufacture the pills, packing plants where they are concealed for export and smuggling networks to spirit them to markets abroad. (Hubbard and Saad, 12/5)

Also —

The Washington Post: A Greek Alphabet Crash Course, One Covid Variant At A Time 
The 15th letter of the Greek alphabet had been a fairly innocuous entity for 2,500 years. But in just two weeks, it became notorious. Omicron moved beyond classical philosophy texts, beyond the realm of the 13 million or so people who speak Greek as natives, and exploded into use in urgent scientific reports, breaking news headlines and social media feeds around the world. (Harlan, 12/14)

Los Angeles Times: Young Latinos Are Dying Of COVID At High Rates In California
Every morning, Sergio Ayala combed his daughters’ hair into twin braids, dropped them off at school and headed to work. He loved his job as a field supervisor at his brother-in-law’s pest control company. But he wanted to own a business and was studying to become a barber. He hoped to start a college savings fund for his three girls and toddler son. In January, that dream was cut short. His family believes he contracted the coronavirus while practicing his barbering skills in people’s homes. (Reyes-Velarde, 12/9)

NPR: Portugal Has A High Vaccination Rate But It Isn't Taking Chances With Omicron
The week the omicron variant hit Portugal, Violante Rocha — 80 years old and triple-vaccinated — masked up and went to the theater. "Everyone else wore a mask too, of course," she says. "We understand that life is too good to lose. This is how we live with COVID." Portugal has one of the world's highest vaccination rates against the coronavirus and almost all its adults are fully vaccinated. The shots protect people from serious illness but not from catching the virus. Daily infections have been rising again in Portugal and across Europe. Scientists are watching how Portugal and other highly vaccinated countries will fare against the coronavirus' new omicron variant. (Kakissis, 12/15)

USA Today: COVID Vaccine Gap: Omicron Fight Calls For Need To Arm The World
Global health experts’ predictions are being realized. In the midst of tragically unequal vaccination access, a new variant of COVID-19 has emerged. As omicron cases are identified all over the world, no GDP is high enough and no health system strong enough to keep out the truth: Nobody is safe until we are all safe. What is standing in our way of making sure the whole planet gets the vaccines that will actually get this pandemic under control? (Priti Krishtel and Chelsea Clinton, 12/16)

Bloomberg: China's Sinovac Vaccine Won't Fully Protect Against Omicron 
From the moment it became clear we’d have multiple vaccines for SARS-Cov-2, questions about pecking order arose. Which vaccines provided the best protection? The longest lasting? What were the best combinations? What about time between doses? ... According to a recent study, one particular type of jab — what’s called a killed-virus vaccine — does not offer sufficient protection from omicron. That would create a major challenge for countries that relied heavily on such inoculations, such as China. (Therese Raphael and Sam Fazeli, 12/16)

Scientific American: The Risk Of Vaccinated COVID Transmission Is Not Low 
My two-year-old tested positive for COVID last month. My mind-numbing and costly project to keep him uninfected prior to his vaccinations had proven an abject failure. I was angry—and surprised. During the time he was likely infected, he had only been around vaccinated people when indoors. Although we know the absolute risk of serious illness in young children is low, there are many other causes for concern as a result of unvaccinated infection: multisystem inflammatory syndrome (MIS-C, long COVID, silent organ or brain damage, psychiatric or chronic disease later in life, and damage to smell.) While I’ll never know exactly who infected my son, his infection drove me to discover something that only came into focus in late October: the risk of vaccinated transmission is not low. (Jennifer Frazer, 12/16)

Los Angeles Times: Pandemic Fatigue Has Americans Glossing Over Omicron. But We Can't Give Up 
The holidays should be a time for getting together with friends and family, but instead we have a double dose of coronavirus strains — Delta and Omicron. Whether we are exhausted from the pandemic or not, we still need to prevent the spread of infections. Fortunately, we know what works. For indoor gatherings, each person should be fully vaccinated with a booster shot, or, for someone with a confirmed prior COVID infection, at least one vaccine dose. They all should have frequent rapid antigen tests for the days prior to and time of gathering. These tests screen for whether a person is infectious, which is far more important than whether they have been infected but not capable of transmitting the virus. Ideally, all gatherings would be outdoors, but if that’s not possible, maximizing ventilation with windows open or HEPA air filtration with CO2 monitoring provides good air quality. (Eric J. Topol, 12/16)

CNN: Why My Covid Anxiety Is Spiking Now, All These Months Later 
I remember the moment distinctly. It was Thanksgiving. We  --  my wife, kids and mom --  were at my college friend's house with his family. Everyone was vaccinated and we had all taken rapid tests that morning to make sure it was safe to celebrate together. That was the last day I felt relatively unworried about Covid-19. (Looking back, I remember someone at that Thanksgiving dinner mentioning something about a "new variant," but the combination of turkey, mashed potatoes and, well, a few mixed drinks, made it easy to overlook.) Since the word "Omicron" entered our lexicon, every day has been filled with varying levels of stress. (Chris Cillizza, 12/17)

Stat: Emory And Other Universities' Licensing Deals Shouldn't Perpetuate Inequity
As billions of people in the Global South continue to confront Covid-19 unprotected because they cannot access vaccines, a recent announcement regarding a new, potentially effective therapy offered a glimmer of hope. In late-stage clinical trials, a new antiviral pill from Merck, called molnupiravir, cut hospitalizations and deaths from Covid-19 by one-third. A federal advisory committee, in a narrow vote, recommended that the Food and Drug Administration authorize emergency use of the drug as the first oral treatment for Covid-19. If authorized, it could potentially become available for patients in the United States within weeks. (Merith Basey, 12/17)

Bloomberg: As China Limits Vasectomies, Many Ask What’s Next 
China’s government has been warning about limited supplies of everything from energy to poultry this winter. But another shortage has lately raised some more existential concerns: Vasectomies are increasingly hard to come by. Large public hospitals in China’s biggest cities have stopped offering the procedure, or are restricting it to married men with children, according to a recent report in the Washington Post. No formal policy exists on the matter. But thanks to China’s rapidly falling birthrate, and the government’s avowed determination to reverse it, physicians and hospital administrators are taking the hint. (Adam Minter, 12/16)

The Boston Globe: New York Is Home To The First Supervised Injection Sites In America. Let Boston Be Next. 
With about a month left in office, Mayor Bill de Blasio of New York announced the opening of the first two sanctioned safe consumption facilities in the country, designated places where opioid users can inject illegal drugs like heroin and fentanyl under medical supervision. For such a controversial move, it was done quietly. But make no mistake: De Blasio’s step is a major milestone in the fight against the opioid epidemic, which has continued to rage in the shadows of the COVID-19 pandemic. (12/17)

The New York Times: Is Our Homelessness Crisis Really A Drug Problem? 
How much of America’s homelessness crisis can be attributed to a deepening nationwide addiction problem and new forms of meth and fentanyl that destroy or just straight-up end people’s lives? And can we even begin to talk about permanent housing solutions before we address the drug problem? (Jay Caspian Kang, 12/16)

Stat: Health Care Workers Suffer From More Than Burnout 
We survived the pandemic’s early days with purpose-fueled adrenaline. Working in the epicenter of the first Covid-19 outbreak in the U.S., two of us (R.H. and K.H.) scrambled to transition as many patients as possible to telemedicine, but still worked on site in the hospital. Soon afterward, T.N. was on the frontlines as highly infectious patients flooded her intensive care unit. Our caseloads grew, and we worried about bringing Covid-19 home from the hospital and infecting vulnerable family members. Encouraged to engage in self-care, we walked and connected with colleagues. Eventually the pandemic took its toll, causing burnout, insomnia, anxiety, and grief. Mounting evidence shows we aren’t alone. (Rebecca Hendrickson, Katherine Hoerster and Thanh Neville, 12/16)

The Star Tribune: Ethical Decision Is Protecting Patients 
Generations of families have brought their loved ones to Mayo Clinic when disease strikes, sometimes traveling thousands of miles to do so. The trust placed in this renowned medical center obligates it to put patients' health first at all times. In a pandemic, that means requiring COVID-19 vaccinations for staff. Those who come to Rochester for healing should expect that their caregivers have done everything possible to prevent infection from a potentially deadly virus. ... Disturbingly, 38 Republican legislators in Minnesota recently signed a letter accusing Mayo of unethical behavior for enforcing this vital patient protection policy. (12/16)

The Tennessean: Free Access To Family Planning Resources Will Help Strengthen Families
Access to medically-accurate information and effective forms of free contraceptive care is essential for women living in Middle Tennessee. Healthy women equal healthy children and healthy families. During this time of rebuilding from natural disasters and COVID-induced setbacks, it is more important than ever that every woman, regardless of her income level, insurance coverage or employment status, has an opportunity to access costly but highly effective birth control known as LARC (long-acting, reversible contraception). (Jacqueline B. Dixon and Revida Rahman, 12/16)

Stat: Trying To Answer The Big Questions About Drug Prices Is Hard To Do
Public debate over legislation to allow Medicare to negotiate the price of drugs has been dominated by stories of personal suffering caused by high drug prices, accounts of lifesaving cures provided by pharmaceutical innovations, and arguments regarding nuanced economic models of how reducing drug prices could affect government spending and pharmaceutical innovation. Big questions related to the role of companies or government in providing for the health of the public have gotten short shrift. (Fred D. Ledley, 12/16)