NPR: Dr. Robert Califf Confirmed To Again Head The FDA
Dr. Robert Califf will once again head the Food and Drug Administration, narrowly securing his position as the head of the consumer safety agency. The Senate confirmed Califf on Tuesday despite some concerns over his close ties to the pharmaceutical industry and GOP opposition to his stance on access to birth control. The Senate voted to confirm Califf on a 50-46 vote, split largely along party lines. Six Republicans — Sens. Roy Blunt, Richard Burr, Susan Collins, Lisa Murkowski, Mitt Romney and Patrick Toomey — voted alongside Democrats to confirm the Duke University cardiologist. (Wise, 2/15)

The Washington Post: Califf Narrowly Confirmed For FDA Commissioner, Providing Beleaguered Agency With Its First Permanent Chief In 13 Months
Robert M. Califf, a cardiologist who led the Food and Drug Administration briefly in 2016, was confirmed Tuesday by a razor-thin 50-to-46 vote for a second stint as commissioner, giving the embattled agency its first permanent head in more than a year. The cliffhanger Senate vote capped a drama that began last fall, when Califf, 71, was nominated by the Biden administration and widely viewed as a shoo-in, given the overwhelming bipartisan support he received in 2016. But this time around, his nomination was endangered by surprisingly strong opposition from most Republicans and a handful of Democrats. (McGinley and Roubein, 2/15)

AP: Senate Confirms Biden's FDA Pick Despite Political Divisions
White House press secretary Jen Psaki said the administration is “thrilled” that the Senate confirmed Califf on a bipartisan basis. “He brings to this critical post a lifetime of knowledge and the institutional experience that will ensure he hits the ground running,” she said. (Perrone and Freking, 2/15)

Stat: Senate Narrowly Confirms Robert Califf To Lead The FDA 
The vote puts an end to one of the most protracted and controversial confirmation processes in the FDA’s 115-year history. No candidate for the agency’s top job has so narrowly squeaked through the confirmation process. The only candidate that came close was Scott Gottlieb, who led the agency during the Trump administration and was confirmed 57-42. Ultimately, four Democrats voted against Califf’s nomination: Joe Manchin (W.Va.), Ed Markey (Mass.), Richard Blumenthal (Conn.), Maggie Hassan (N.H.). So too did Independent Sen. Bernie Sanders (Vt.) (Florko, 2/15)

Roll Call: Senate Confirms Califf To Become Biden's FDA Commissioner
At the last minute, Sen. Mike Rounds, R-S-D., changed his "no" vote to "present" to pair with Sen. Ben Ray Lujan, D-N.M, who would have voted in favor of the nomination. Lujan is absent from the Senate after suffering a stroke. Sen. Shelley Moore Capito, R-W.Va., was absent following a recent COVID-19 diagnosis and Sen. Lindsey Graham, R-S.C., was also absent. Califf had to cut deals with multiple lawmakers, trading policy promises for votes. Several Senate Democrats opposed the nomination due to his past ties to the pharmaceutical industry and handling of the opioid crisis when he previously led the FDA. (Cohen, 2/15)

Also —

Politico: Califf Confirmed: The 6 Challenges That Await The New FDA Commissioner 
With a permanent political leader in place after a 13-month holding pattern, the agency will be more empowered to move forward with sensitive policies and accelerate its regulatory agenda. Returning to the FDA early in President Joe Biden’s tenure gives Califf greater ability to place his stamp on the agency than the last time he led it during the final months of the Obama administration. Scott Gottlieb, former President Donald Trump’s first FDA commissioner, played an outsized role communicating with lawmakers on Capitol Hill about the agency’s priorities. (Gardner, Foley, Lim and Ollstein, 2/15)

Stat: 6 Approval Decisions That Will Make Or Break Califf’s First Year At The FDA
The next year at the Food and Drug Administration is going to make Robert Califf’s marathon confirmation process look easy. The longtime Duke cardiologist, who was narrowly confirmed by the Senate Tuesday, inherits an agency that is smack dab in the middle of deliberations over a slew of controversial applications for everything from pediatric Covid-19 vaccines to ALS drugs. Califf likely won’t weigh in on the minutiae of those decisions — it’s extremely rare for the FDA commissioner to do so — but these decisions will have huge consequences for his tenure at the FDA. He will have to explain the decisions to the public, and he will take the blame for any misstep the agency makes. (Florko, 2/16)

The Washington Post: A Middle-Aged Woman Is The Third Patient To Be Potentially Cured Of HIV, Scientists Report 
A middle-aged, mixed-race woman is the third patient to be potentially cured of HIV, with the virus in long-term remission four years after she received a transplant of stem cells harvested from an infant’s umbilical cord blood, scientists said Tuesday. The new case, reported at the annual meeting of the Conference on Retroviruses and Opportunistic Infection, is the first time the transplant approach has been successfully reported in a mixed-race woman, an advance that reinforces the exciting concept that an HIV cure may be possible in a wider array of people by using cord blood. (Johnson, 2/15)

ABC News: Breakthrough Treatment Makes Woman 3rd Person To Be Cured Of HIV
"This case is special for several reasons: First, our participant was a U.S. woman living with HIV of mixed race, who needed a stem cell transplant for treatment of her leukemia. And she would find a more difficult time finding both a genetic match and one with the HIV-resistant mutation to both cure her cancer and potentially her HIV. This is a natural, but rare mutation," said Dr. Yvonne Bryson, an infectious disease physician at UCLA who led the study. (Morrison and Salzman, 2/15)

The New York Times: A Woman Is Cured Of H.I.V. Using A Novel Treatment 
Cord blood is more widely available than the adult stem cells used in the bone marrow transplants that cured the previous two patients, and it does not need to be matched as closely to the recipient. Most donors in registries are of Caucasian origin, so allowing for only a partial match has the potential to cure dozens of Americans who have both H.I.V. and cancer each year, scientists said. The woman, who also had leukemia, received cord blood to treat her cancer. It came from a partially matched donor, instead of the typical practice of finding a bone marrow donor of similar race and ethnicity to the patient’s. She also received blood from a close relative to give her body temporary immune defenses while the transplant took. (Mandavilli, 2/15)

CNBC: Scientists Have Possibly Cured HIV In A Woman For The First Time
It is unethical, experts stress, to attempt an HIV cure through a stem cell transplant — a toxic, sometimes fatal procedure — in anyone who does not have a potentially fatal cancer or other condition that already makes them a candidate for such risky treatment. (Ryan, 2/15)

In other news about HIV/AIDS —

NBC News: Breakthrough HIV Reported In Injectable PrEP Trial; Experts Say Drug Still Very Effective
In a large clinical trial assessing Apretude, ViiV Healthcare’s recently approved injectable drug, as a form of HIV prevention, seven participants contracted the virus despite receiving their injections on schedule. The new findings indicate that, just as with those who take daily pills to prevent HIV, breakthrough infections are possible among people receiving Apretude. (Ryan, 2/15)

aidsmap: COVID-19 Vaccine Booster Produces Strong Responses In People With HIV With Low CD4 Counts
Booster doses of the Pfizer or Moderna vaccines revive antibody levels in people with HIV and response to a booster dose is not affected by CD4 count, Italian researchers reported at the Conference on Retroviruses and Opportunistic Infections (CROI 2022) this week. But at the conference's opening session, vaccine researcher Professor Dan Barouch questioned whether a strategy of relying on repeated boosters will be either necessary or feasible. He also called for a focus on the whole of the immune response, not just antibodies, when considering which vaccines to use and when boosters should be offered. (Alcorn, 2/15)

AP: AP Sources: White House Seeks Another $30B For COVID Battle 
The Biden administration is telling Congress that it needs an additional $30 billion to press ahead with the fight against COVID-19, officials said. Two people familiar with the administration’s plan confirmed key details on Tuesday: $17.9 billion for vaccines and treatments, $4.9 billion for testing, $3 billion to cover coronavirus care for uninsured people, and $3.7 billion to prepare for future variants. They spoke on condition of anonymity to discuss deliberations between the administration and lawmakers over the supplemental funding. (Miller and Alonso-Zaldivar, 2/16)

CBS News: Biden Administration Wants $30 Billion More In Federal Funding For COVID-19 Response 
The issue of additional aid has been the subject of discussions across Washington in recent weeks, and White House press secretary Jen Psaki confirmed the administration is seeking more money to address future needs. "While we continue to have sufficient funds to respond to the current Omicron surge, in the coming weeks, our goal has always been to ensure that we are well-prepared to stay ahead of the virus," Psaki said at a White House briefing on Tuesday. (O'Keefe, 2/15)

In related news —

Reuters: U.S. Says It Could Spend $22 Mln A Month Testing Unvaccinated Federal Employees 
The U.S. government said it faces "significant harm" if an a appeals court fails to reverse an injunction barring enforcement of President Joe Biden's COVID-19 vaccine mandate for government workers, and that testing unvaccinated employees could cost up to $22 million a month. White House Office of Management and Budget Deputy Director Jason Miller disclosed in an declaration cited late on Monday by the Justice Department that the government would be hurt on several fronts if it cannot enforce the vaccine requirements. (Shepardson, 2/15)

Drug pipes and vaccine mandates are debated on Capitol Hill —

The Wall Street Journal: Sen. Marsha Blackburn Drops Stopgap Spending Bill Hold Over Drug Pipes
Sen. Marsha Blackburn lifted a hold on a stopgap bill needed to avoid a partial government shutdown this weekend after she won a commitment from the Biden administration that it wouldn’t fund pipes for smoking illicit substances through a substance-abuse program. ... In a letter Tuesday, Health and Human Services Secretary Xavier Becerra wrote that “no federal funding will be used directly or through subsequent reimbursement of grantees to put pipes in safe smoking kits.” He had previously issued a similar statement through a press release, but not in a letter to Congress. (Hughes, 2/15)

Houston Chronicle: Ted Cruz, Chip Roy Threaten Government Shutdown Over Biden Vaccine Mandates
Texas Republicans are again threatening a government shutdown over President Joe Biden’s vaccine mandates as the Senate works to pass a short-term funding bill by the end of the week. Sen. Ted Cruz is among a group of four Senate Republicans who have signed a letter led by Rep. Chip Roy of Austin refusing to support any bills funding the federal government that include money for the enforcement of COVID-19 vaccine mandates at “any level of government.” (Wermund, 2/15)

The Washington Post: U.S. ‘Excess Deaths’ During Pandemic Surpassed 1 Million, With Covid Killing Most But Other Diseases Adding To The Toll, CDC Says
The United States has recorded more than 1 million “excess deaths” since the start of the pandemic, government mortality statistics show, a toll that exceeds the officially documented lethality of the coronavirus and captures the broad consequences of the health crisis that has entered its third year. The excess-deaths figure surpassed the milestone last week, reaching 1,023,916, according to Robert Anderson, chief of the mortality statistics branch of the Centers for Disease Control and Prevention’s National Center for Health Statistics. The center updates its estimate weekly. (Achenbach, 2/15)

In other news about the spread of the coronavirus —

Bloomberg: Idaho Withdraws Hospital Rationing As Staffing Improves
Idaho, one of the least-vaccinated U.S. states, withdrew pandemic hospital rationing Tuesday as staffing and blood supplies improved, officials said. Hospitals in the southern part of the state, including the capital of Boise, were placed under crisis standards of care during the Covid-19 omicron outbreak earlier this year. Even so, Idaho’s hospitals remain under stress, Dave Jeppesen, director of the state Department of Health and Welfare, said during an online briefing. (Del Giudice, 2/15)

Milwaukee Journal Sentinel: COVID-19 Levels In Wisconsin Wastewater A Sign Omicron Is In Decline
Wastewater from both the Jones Island and South Shore sewer sheds in Milwaukee have shown a decline in the presence of COVID-19 over the last month, yet another sign that the omicron variant surge is nearing an end, health officials said Tuesday. "Throughout the pandemic, these trends have been predictive and largely mirror disease burden in the community as reflected through case numbers and positivity rates," said Ben Weston, chief health policy adviser for Milwaukee County. "Similar to other points in the pandemic, this trend reflects the trajectory of the current phase of the pandemic, which is that our disease burden from omicron is quickly and thankfully receding." (Bentley, 2/15)

Bay Area News Group: CDC: Omicron Drove Up Kids' COVID-19 Hospitalization Rates
Bay Area pediatricians knew omicron was like nothing they’d seen before for their youngest patients, and a new study released Tuesday confirms their alarm: The highly contagious variant sent kids to U.S. hospitals at rates four times higher than delta, and rates were higher still for those under age 5, who are too young for COVID-19 vaccination. Although kids have been least vulnerable to the virus, the rise in severe illness among them as cases surged this winter alarmed health officials who have pleaded with parents to get their children vaccinated. “We all went into pediatrics to make kids better, so seeing them suffer in the hospital and outside, it’s hard,” said Jenna Holmen, a pediatric infectious disease specialist at UCSF Benioff Children’s Hospital Oakland, which was forced to double occupancy in some rooms during the height of the omicron surge. (Woolfolk and DeRuy, 2/15)

CNBC: Moderna CEO: Reasonable To Think Covid Pandemic May Be In Final Stages
Moderna’s CEO Stephane Bancel said it’s “reasonable” to assume that we may be approaching the final stages of the pandemic. “I think that is a reasonable scenario,” he told CNBC’s “Squawk Box Asia” when asked about views that the Covid-19 pandemic may now be in its final stages. “There’s an 80% chance that as omicron evolves or SarsCov-2 virus evolves, we are going to see less and less virulent viruses,” he said Wednesday. He also said there’s another “20% scenario where we see a next mutation, which is more virulent than omicron.” (Bala, 2/16)

The Washington Post: CDC Lowers Cruise Travel Warning From ‘Very High’ To ‘High’ 
The Centers for Disease Control and Prevention says taking a cruise now presents a lower risk than it did at the end of 2021 — at least in some cases. On Tuesday, the public health agency lowered its travel health notice for cruises from Level 4 to Level 3, which indicates covid-19 levels on ships are “high” rather than “very high.” The agency had been warning all travelers to avoid cruise travel regardless of vaccination status since Dec. 30, after the omicron surge sent cases on ships soaring. (Sampson, 2/15)

Dallas Morning News: 5 Gorillas Infected With COVID-19 At Dallas Zoo Have Omicron Variant, Results Confirm
The five gorillas at the Dallas Zoo who tested positive for COVID-19 last week are infected with the omicron variant. Lowland western gorillas Asha, B’Wenzi, Marcus, Shana and Shanta tested positive for the virus Feb. 7 from samples that were taken Feb. 1. The National Veterinary Services Laboratory confirmed the zoo’s preliminary results Tuesday, the zoo said Tuesday on Facebook. All of the gorillas are still asymptomatic, the zoo said. (Marfin, 2/15)

Bloomberg: Surgeon General Vivek Murthy Toddler Tests Positive, Spurs Warning On Covid Risk
Joining worried parents across the country, U.S. Surgeon General Vivek Murthy announced on Twitter Tuesday that his 4-year-old daughter had tested positive for Covid-19. “Staring at my daughter’s positive test, I asked myself the same questions many parents have asked: Will my child be ok? Could I have done more to protect her? Was this my fault? In these moments, it doesn’t matter if you’re a doctor or Surgeon General,” Murthy wrote. “We are parents first.” (Muller, 2/15)

Also —

CIDRAP: Many COVID-19 Patients Left With Bills After Cost-Sharing Waivers Expired
A large proportion of US COVID-19 patients were left with thousands of dollars of hospital bills after many health insurers stopped issuing cost-sharing waivers in early 2021, finds a study published yesterday in JAMA Network Open.A team led by University of Michigan at Ann Arbor researchers mined the IQVIA PharMetrics Plus for Academics database for COVID-19 hospital claims for patients covered by Medicare Advantage or private insurance from Mar 1, 2020, to Mar 30, 2021. (2/15)

NPR: When Moms Get Vaccinated During Pregnancy, Babies Get Protection Too, Study Shows
Getting vaccinated against COVID-19 during pregnancy may also help protect babies after they're born, according to new research published by the Centers for Disease Control and Prevention. Babies whose mothers received two shots of either the Pfizer or Moderna vaccines during pregnancy had a 61% lower risk of being hospitalized with COVID in their first six months of life, the study found. "The bottom line is that maternal vaccination is a really important way to help protect these young infants," said Dr. Dana Meaney-Delman, chief of the CDC's Infant Outcome Monitoring, Research and Prevention branch. She notes that is particularly important because there's no vaccine authorized for babies under 6 months old. (Godoy, 2/15)

CBS News: Infants Born To Vaccinated Mothers Are Less Likely To Be Hospitalized With COVID, CDC Study Finds
Scientists studied 379 infants under the age of six months at 20 different children's hospitals across 17 states from July 2021 to January 2022. Of the 176 babies who were hospitalized with COVID-19, 84% of them were born to mothers who did not get vaccinated during their pregnancy, the study determined. Researchers also found that 88% of babies admitted to intensive care units with COVID-19 were born to mothers who were not vaccinated. The one infant who died during the study was born to an unvaccinated mother. (Powell, 2/15)

CNBC: Babies Are Protected From Hospitalization For Covid If Their Moms Get Vaccinated, Study Suggests
Dr. Dana Meaney-Delman, head of the CDC’s infant outcomes branch, said the study suggests antibodies transferred from the mother to her developing fetus protect the newborn against Covid. “Unfortunately, vaccination of infants younger than 6 months old is not currently on the horizon, highlighting why vaccination during pregnancy is so important for these young infants,” Meaney-Delman told reporters during a conference call on Tuesday. (Kimball, 2/15)

In other vaccine research —

The Washington Post: Vaccines Could Lower Risk Of ‘Long Covid,’ U.K. Health Agency Says
Vaccination lowers the risk of developing long-term effects of covid-19, according to a report released Tuesday by a British public health agency. At least 50 percent of people who survive covid-19 experience a variety of physical and psychological health issues for six months or more after their initial recovery, according to research on the long-term effects of the disease. The adverse symptoms associated with “long covid” vary from person to person but generally include fatigue, shortness of breath and cognitive difficulty, among other maladies. (Cheng, 2/16)

And in covid research —

Fox News: Severe, Critical COVID-19 Cases More Likely In Vitamin D-Deficient People: Study
People who have a vitamin D deficiency are more likely to have a severe or fatal case of COVID-19, researchers said. In a retrospective study published in the journal PLOS ONE, scientists from Galilee Medical Center and Bar Ilan University in Israel examined the records of more than 1,176 patients admitted between April 7, 2020, and Feb. 4, 2021, to the Nahariya-based Galilee Medical Center with positive PCR (polymerase chain reaction) tests for SAR-CoV-2. Those records were searched for vitamin D levels measured two weeks to two years prior to infection. (Musto, 2/15)

CIDRAP: Higher Estrogen In Older Women May Lower The Risk Of COVID-19 Death
Older women's estrogen levels may be linked to their chances of dying from COVID-19, with higher levels of the hormone seemingly protective against severe infection, according to an observational study yesterday in BMJ Open. The study included 14,685 postmenopausal Swedish women from 50 to 80 years old who had COVID-19. Researchers divided them into three groups: (1) women with previously diagnosed breast cancer and receiving endocrine therapy (decreased estrogen levels), (2) women receiving hormone replacement therapy (increased estrogen), and (3) a control group of women not receiving either therapy. (2/15)

Bloomberg: Study Shows Omicron Sub-Variant No More Severe Than First Strain
A South African study showed that the risk of hospitalization from the omicron BA.2 sub-variant is similar to that from the original strain, a senior scientist said. The study in the country, where the BA.2 strain is now dominant, may not extrapolate to other countries as most of the immunity South Africans have is from prior infections with Covid-19 rather than vaccinations, Cheryl Cohen, head of the Centre for Respiratory Diseases at the National Institute for Communicable Diseases, said on an online press conference. That could give better protection she said. The emergence of BA.2 caused concern as it appears to be more transmissible than BA.1, the strain first identified. (Sguazzin, 2/16)

The Washington Post: Disney World, Disneyland To Drop Mask Mandate For Vaccinated Guests 
Disney World and Disneyland will drop their mask requirement for vaccinated guests, starting Thursday. Since July 2021, Disney’s Florida and California theme parks have required masks in indoor spaces for guests 2 years old and older, regardless of vaccination status. Disney does not require proof of vaccination to enter its parks. (Finnegan, 2/15)

Variety: Coachella And Stagecoach Festivals Drop All Covid-Related Restrictions
After revealing last fall that vaccinations would not be required for entry, the Coachella and Stagecoach festivals have further revealed that there will no longer be any Covid-related barriers to entry at all, not even negative tests. Nor will a requirement to wear masks figure into the picture when millions of selfies go out from the desert this April. (2/15)

New Orleans Times-Picayune: Mask, Vaccine Mandates To Remain Through Mardi Gras After Supreme Court Decision
Mardi Gras 2022 will stay masked and vaxxed in New Orleans, following a decision from the Louisiana Supreme Court. Justices last week declined to hear an emergency request from the more than 100 plaintiffs in a lawsuit filed two weeks ago, which was aimed at striking down Mayor LaToya Cantrell’s COVID restrictions in time for Carnival’s high days. The sole justice to dissent was Will Crain. Instead, a litany of rules on gatherings in public places will remain in force throughout Carnival season. For now, people attending most indoor events are required to wear masks. They must also show proof of vaccination or a recent negative COVID-19 test if they hope to drink at a bar, dine at a restaurant or party at a nightclub, among other places. (Sledge, 2/15)

As states return to "normal," the CDC might be acting too late —

NBC News: CDC Masks: The CDC Is Expected To Update Mask Guidance As Early As Next Week
The Centers for Disease Control and Prevention is expected to loosen its indoor masking guidelines to states soon, according to several people familiar with the matter. The agency’s update could come as early as next week. Dr. Rochelle Walensky, the director of the CDC, is expected to discuss masking guidance Wednesday at a White House Covid-19 Response Team briefing. Nothing has been finalized yet, but the CDC is considering a new benchmark for whether masks are needed, basing it on the level of severe disease and hospitalizations in a given community, two people familiar with the situation said. (Lovelace Jr. and Przybyla, 2/15)

Stateline: States Craft Their COVID Exit Strategies
As omicron fades and scientists consider when to declare COVID-19 endemic—and, therefore, here to stay—in the United States, governors in 10 states last week leapfrogged federal recommendations and dropped mask mandates. One by one, governors and health officials in California, Connecticut, Delaware, Illinois, Massachusetts, Nevada, New Jersey, New York, Oregon and Rhode Island broke ranks and announced an end date for masking requirements in indoor public spaces such as grocery stores and restaurants and, in some cases, schools. They were joined this week by District of Columbia Mayor Muriel Bowser, a Democrat. (Vestal, 2/15)

AP: Companies Revert To More Normal Operations As COVID Wanes
For the first time in two years for many people, the American workplace is transforming into something that resembles pre-pandemic days. Tyson Foods said Tuesday it was ending mask requirements for its vaccinated workers in some facilities. Walmart and Amazon — the nation’s No. 1 and 2 largest private employers respectively — will no longer require fully vaccinated workers to don masks in stores or warehouses unless required under local or state laws. Tech companies like Microsoft and Facebook that had allowed employees to work fully remote are now setting mandatory dates to return to the office after a series of fits and starts. (D'Innocenzio, 2/16)

AP: Virginia Governor Seeks March 1 End To School Mask Mandates 
School mask mandates in Virginia will end on March 1 if the General Assembly adopts amendments made by Republican Gov. Glenn Youngkin to just-passed legislation on the issue. The legislature passed a bill Monday giving parents and students the ability to opt out of mandates imposed by local school boards. But the legislation would not have taken effect until July 1. (2/15)

Roll Call: Masking Battles Show How Issue That Buoyed Biden Won’t Help Party In ’22
The official transcript of President Joe Biden’s 20-minute speech about lowering the cost of health care last week in Virginia Rep. Abigail Spanberger’s district was more than 3,300 words. “Masks” was not one of them, even though the administration decided just weeks earlier to make high-quality masks available free at retailers and pharmacies around the country as another step to curb the COVID-19 pandemic. Since then, governors in blue states such as New Jersey and California announced they would lift mandates that people wear masks indoors. They said it was because the omicron spike in infections had come down markedly without hospitals being overwhelmed, but it also comes after Republican Glenn Youngkin successfully tapped into public fatigue with the pandemic to flip a blue state in the Virginia governor’s race three months ago. (McIntire, 2/16)

The Boston Globe: Appeals Court Grants Injunction Against Wu’s Workforce Vaccination Mandate
An appeals court judge Tuesday granted an injunction blocking Mayor Michelle Wu’s administration from enforcing a COVID-19 vaccination mandate for workers from three municipal unions until the two sides hash out a solution at the bargaining table, state labor authorities decide the matter, or there is a court resolution to the case. The decision from Justice Sabita Singh represented a blow to Wu’s vaccination mandate, a policy that has dominated her early tenure in City Hall’s fifth-floor corner office, and the latest turn in a COVID-19 fight that has pitted the city’s new and progressive mayor against a bloc of decidedly old-school Boston power: a trio of public safety unions. (McDonald, 2/15)

AP: House Committee OKs Ban On Businesses Requiring Vaccinations 
A panel of Idaho lawmakers has advanced a bill that would make it a crime for Idaho businesses to require employees to get vaccinated against the coronavirus. The federal government and companies employing health care workers would be exempt under the bill from Rep. Charlie Shepherd. But all other businesses would be barred from firing, segregating or otherwise treating unvaccinated workers differently than vaccinated employees. (Boone, 2/15)

Los Angeles Times: Judge Dismisses Firefighter Group's Lawsuit Over L.A. Vaccine Policy
A Los Angeles Superior Court judge Tuesday dismissed a lawsuit brought by a group of Los Angeles firefighters over a city requirement that employees be vaccinated against COVID-19. Judge Michael P. Linfield wrote that “courts have consistently held that government has the power to require vaccinations to protect the public’s health and safety.” He cited several cases, including a 1905 U.S. Supreme Court ruling that compulsory vaccinations are allowed under the Constitution. The city last year made COVID-19 vaccination a requirement of employment, while also granting exemptions for employees based on medical conditions or religious beliefs. (Smith, 2/15)

The Washington Post: About 3 In 4 D.C. Residents Support Vaccine Rules Bowser Just Rescinded, Poll Finds
About three-quarters of D.C. residents support the city’s vaccine requirement to enter certain businesses, a policy that Mayor Muriel E. Bowser (D) ended Tuesday. The citywide Washington Post poll finds 74 percent of residents support D.C.’s requirement to show proof of vaccination before going inside restaurants, gyms, concert venues and sports arenas. Most D.C. residents also say Bowser’s restrictions on residents and businesses have been “about right.” (Moyer, Guskin and Brice-Saddler, 2/15)

Billings Gazette: Montana Health Facilities Report Vaccine Compliance, With Some Leaving Jobs
Hospitals, nursing homes and all other Medicaid-accepting facilities across Montana have been busy processing data on staff vaccination, exemptions and, in some cases, unemployment. Feb. 14 marked the first deadline for the Centers for Medicare and Medicaid Services (CMS) COVID-19 vaccine mandate. All employees working at a facility receiving reimbursement from the federal agency are required to provide proof of at least one dose of vaccine or a medical or religious exemption. At Benefis Health System in Great Falls, 37 employees opted to end their employment rather than get vaccinated or try for an exemption. The resignations were not concentrated in a specific department or employee type, according to Whitney Bania, senior communications specialist at Benefis. (Schabacker, 2/15)

AP: GOP-Controlled Arizona Senate Passes 15-Week Abortion Ban
Republicans who control the Arizona Senate voted Tuesday to outlaw abortion after 15 weeks of pregnancy, moving to put a new ban in place ahead of a highly anticipated U.S. Supreme Court decision that could bring seismic changes to abortion availability in the United States. The vote came over objections from minority Democrats who said the measure was unconstitutional under the landmark Roe v Wade and other Supreme Court decisions the high court could overturn. They also said any ban would disproportionally impact poor and minority women who won’t be able to travel to Democratic states without strict abortion laws. (Christie, 2/16)

AP: Abortion Ban After 15 Weeks Passed By West Virginia House
The Republican-dominated West Virginia House of Delegates passed a bill Tuesday that would ban abortion after 15 weeks, a piece of legislation almost identical to the Mississippi law currently under review by the U.S. Supreme Court. The high court’s ruling in the Mississippi abortion case could lead to the overturning of its landmark Roe v. Wade decision, an outcome many conservative lawmakers in West Virginia indicated they are more than in favor of. (Willingham, 2/15)

In abortion updates from West Virginia, Arkansas and Oklahoma —

AP: Arkansas Senate Rejects Push For Texas-Styled Abortion Ban
Arkansas’ majority-Republican Senate rejected a push Tuesday for an abortion ban modeled after Texas’ restrictive law, with abortion opponents divided about emulating their neighbor’s approach as they await a key ruling from the U.S. Supreme Court. The Senate rejected resolutions that would have allowed lawmakers to take up legislation banning abortion except to save the life of a mother in a medical emergency. Like Texas’ ban, the measure would be enforced by private citizens filing lawsuits. (DeMillo, 2/16)

AP: Oklahoma Abortion Providers See Huge Influx Of Texas Women
Two abortion providers in Oklahoma said Tuesday that they’re still seeing a massive influx of women from Texas who want to terminate their pregnancies after Texas last year passed the most restrictive anti-abortion law in the U.S. in decades. Officials with Trust Women and Planned Parenthood Great Plains, which both operate abortion clinics in Oklahoma City, said some women from Oklahoma are being forced to seek abortion services in other states because of two-week wait times for services in Oklahoma. (Murphy, 2/15)

In abortion news from Florida —

WFLA: Florida House To Vote On 15-Week Abortion Ban With No Exceptions For Rape, Incest 
The Florida House of Representatives is expected to pass a bill Wednesday that would ban abortion in the state after 15 weeks of pregnancy, about eight weeks earlier than the current standard. Florida Gov. Ron DeSantis has previously voiced support for the bill. (Muller, 2/16)

Miami Herald: Understanding Florida’s Proposed 15-Week Ban On Abortions
Florida law allows abortion until the third trimester — about 24 weeks of pregnancy. That is around the time when a baby begins to become viable outside the womb. However, there are exceptions in state law that allow third-trimester abortions in cases in which the mother’s life could be at risk, or in which the pregnant person risks “irreversible physical impairment of a major bodily function.” (Wilson, 2/16)

Also —

Politico: Dems, Despite Their Control, All But Concede On Federal Abortion Spending 
Though Democrats won’t publicly admit it, they’re soon set to concede defeat on federal funding for abortion. After months of tense negotiations, the two parties joined together last week on a government spending framework they insist will swiftly lead to a massive deal to boost agency bottom lines into the fall. Officially, they’re agreeing to save specific policy disputes for later, including the longtime debate over the half-century ban on federal funding for abortions, known as the Hyde amendment. But Republicans are already declaring victory in that battle. (Ollstein and Scholtes, 2/15)

AP: SD Senate Rejects Medicaid Expansion, Leaving It To Election
A proposal to expand Medicaid health coverage eligibility was defeated in the South Dakota Senate Tuesday, leaving the decision to voters in the November election. Republican Sen. Wayne Steinhauer had brought a proposal to the Legislature to make Medicaid, a federal-state health insurance program for low-income people, available to people who live below 133% of the federal poverty level. That is currently about $17,000 annually for an individual or $35,000 for a family of four. (2/15)

AP: NC GOP: Medicaid Expansion Vote Possible Later This Year
An up-or-down vote on broad Medicaid expansion in North Carolina could occur before the November elections, key Republican legislators said on Tuesday. A joint House-Senate panel created in the current budget law and tasked with studying health care access and possible expansion holds its first meeting on Friday. The committee could submit proposed legislation to the full General Assembly before this year’s session ends, the budget law says. (2/15)

In other Medicaid news —

Fresh Take Florida: Florida Failed To Pay Thousands Of Claims For The Neediest Children. A Tech Glitch Was Blamed.
Florida failed for nearly three months to pay tens of thousands of health care claims for the state's sickest and neediest children due to software glitches blamed on the corporate merger of its two largest payment vendors, officials and executives said. Families with critically ill children who relied on Medicaid-paid health providers were stranded in some cases. A father in Lake Worth was forced to cut back his contractor work to remain home and care for his son when payments stopped. A mother in Ocala said the company that helped care for her 15-year-old disabled son temporarily shut down because of the payment problems. (Bausch, 2/15)

Georgia Health News: House Panel Endorses More Transparency In Health Plans’ Data 
A House committee Tuesday approved a bill that would require more public disclosure about Georgia health plans serving Medicaid patients and state employees and teachers. House Bill 1276, if it becomes law, would require the main state health agency to post reports showing how many primary care providers these insurance plans offer in a county, along with data on the insurers’ hospital costs and prescription drug spending. Members of the House Health and Human Services Committee did not voice any objections to the measure, which now goes to the Rules Committee in that chamber. (Miller and Grapevine, 2/15)

In Medicare news —

Roll Call: Patients' Groups, Progressives Square Off Over Medicare Alzheimer's Decision
Advocates on both sides of a debate over dramatically restricting Medicare’s coverage of an expensive and controversial Alzheimer’s treatment are waging competing campaigns to influence a final decision in April. The dispute also raises larger questions about whether lawmakers and regulators will revisit the fast-track pathway under which the drug was approved, with the issue even entangling Robert Califf’s embattled nomination to lead the Food and Drug Administration. (Clason, 2/15)

KHN: Inside The Tactical Tug Of War Over The Controversial Alzheimer’s Drug 
The drug industry, patient advocates, and congressional Republicans have all attacked federal officials’ decision to decline routine Medicare coverage for a controversial Alzheimer’s drug. They’ve gone as far as to accuse them of tacit racism, ageism, and discrimination against the disabled — and hinted at a lawsuit — over the decision to pay only for patients taking the drug in a clinical trial. The drug, Aduhelm, with a listed price tag of $28,500 a year, has had few takers in the medical world. Brain doctors are leery of administering the intravenous drug because it appears dangerous and largely ineffective. Many of the nation’s most prestigious hospitals — such as the Cleveland Clinic, Johns Hopkins Hospital, and Massachusetts General in Boston — have declined to offer it to patients. (Allen, 2/16)

Philadelphia Inquirer: Plantar Fasciitis, Achilles Tendinitis, Foot Pain Symptoms Rising During COVID-19 Pandemic
Foot pain has been on the rise during the pandemic, as people working from home kicked off their supportive shoes in favor of flimsy slippers and flip-flops, while others, including Hudson, used the time to become more active, which put new strain on their feet. “In March 2020 I said … ‘Oh, my goodness, everyone is going to have plantar fasciitis and Achilles tendinitis,” recalled Laura Virtue-Delayo, the president of the Pennsylvania Podiatric Medical Association. Her prediction panned out: Podiatrists, orthopedic surgeons and physical therapists say they’re seeing more cases of plantar fasciitis and Achilles tendinitis — two common foot-pain conditions — than ever before. (Gantz, 2/15)

In news about health and race —

USA Today: COVID Pushed More Americans Outdoors. But Racial Inequities Persist
For adults, past research has linked time spent in nature to decreased risk of cardiovascular disease, obesity, diabetes, and mental distress, noted Peter Newman, head of Penn State’s Department of Recreation, Park and Tourism Management and co-author with Taff and Rice. Because health problems usually get worse during a pandemic, the value of outdoor recreation is even greater, Newman said. “Outdoor recreation and parks really should be part of the discourse on public health,” Newman said. “These are places where people not only feel better, but there are measurable health benefits.” (Bagenstose, 2/15)

KHN: What Does It Say About Your Neighborhood If The Supermarket Isn’t So Super?
Though I grew up in Roxbury, “the heart of Black culture in Boston,” I now live in Los Angeles, where I typically shop for groceries at Whole Foods Market or Trader Joe’s. Their produce is fresh, green, abundant. Organic options beckon as you walk in the door. So it gnawed at me, a Black woman, when I recently walked into a supermarket in a lower-income L.A. neighborhood and was greeted instead by an array of processed, high-sugar, high-sodium foods — often offered with a nice discount: Coca-Cola products, five 2-liter bottles for $5; sugary cereals, two for $4; boxed brownie and cake mixes, four for $5. The pandemic had underlined long-standing health disparities of Black and brown communities. (Giles, 2/16)

In other public health news —

USA Today: Pig Heart Transplant Patient Enjoys Super Bowl 5 Weeks After Surgery
A marvel of modern science, David Bennett continues to defy odds, surviving more than a month after his pig heart transplant. On Sunday, Bennett sat up in bed and meekly sang “America the Beautiful” as Jhené Aiko belted out her rendition prior to Super Bowl LVI. Bennett, who received a genetically modified pig heart during a transplant on Jan. 7, is recovering at the University of Maryland Medical Center. “The heart is doing great. We have several cardiologists trying to find any fault in it but they have not been able to do it,” said lead surgeon Dr. Muhammad M. Mohiuddin, Professor of Surgery and Director of the Cardiac Xenotransplantation Program at the University of Maryland School of Medicine. “The heart is contracting vigorously as it should. It has shown no signs of rejection.” (Walters, 2/15)

NPR: Homeless Youth And Children Are Wildly Undercounted, Advocates Say
Dominique Marshall moved a lot in her youth. She called many different places "home" over short periods of time when she was 17. She learned at a young age that the public school staff and liaisons she grew up around weren't adequately trained to recognize homeless students. "I wasn't identified at the school I was at and because of that I didn't qualify for many services until I went to a shelter," Marshall, 23, says. "Even then, the liaison in Philadelphia didn't really have a conversation about what was going on." (Beiner, 2/15)

Stat: This Family Carried A Rare Mutation That Should Have Been Lethal 
The result didn’t make sense. The researcher kept scanning the mouse’s pregnant belly, back and forth, back and forth. They could see the embryos on the ultrasound screen, cocoon-like, in grayscale — but there were no heartbeats. It should’ve been visible by now, at eight and a half days, a rhythmic flashing, a clue that the organ was on its way. Instead, each outline was utterly still, dead before it had come to life. That couldn’t be right. These mice carried the exact same genetic mutation as a family who lived about an hour away, in the county outside Pittsburgh, near the West Virginia line. The humans definitely had beating hearts. (Boodman, 2/15)

KHN: Demand For Service Dogs Unleashes A ‘Wild West’ Market 
Jenni Mahnaz admits she’s not much of a dog person. She’s mildly allergic and the only pet she had as a child was a hermit crab. But once she learned that specially trained dogs could help her daughters with their medical needs, she was willing to do anything to make it happen. Her oldest daughter, Suraiya, 6, was diagnosed with autism and sensory processing challenges. Soon after, 4-year-old Phoenix was diagnosed with epilepsy. “Our family is very likely to end up with two service dogs,” Mahnaz said. “I think we’re probably looking at $10,000 per dog.” (Hawryluk, 2/16)

Modern Healthcare: HHS Gives $55M To Community Health Centers For Virtual Care Access
The Health Resources and Services Administration has distributed $54.6 million to 29 community health centers as part of its efforts to increase access to telehealth, remote patient monitoring and other digital tools among underserved populations, the Health and Human Services Department announced Tuesday. "Virtual care has been a game-changer for patients, especially during the pandemic," HHS Secretary Xavier Becerra said in a news release. "This funding will help health centers leverage the latest technology and innovations to expand access to quality primary care for underserved communities." (Devereaux, 2/15)

In other health care industry news —

Axios: Hartford HealthCare Faces Antitrust Lawsuit Over Insurance Contracts 
A group of citizens in Connecticut is suing Hartford HealthCare, alleging the large hospital system has amassed monopoly power "to extract higher prices from insurers, employers, and patients." This is another class-action lawsuit arguing hospital consolidation has crushed everyone's bank accounts and has led to the rise of anti-competitive contracts that force insurers and employers to accept take-it-or-leave-it terms. (Herman, 2/16)

Modern Healthcare: Anthem Partners With Digital Therapeutic For Virtual COVID Care
Anthem has partnered with a digital therapeutics startup to launch a care navigation program for COVID-19 patients. The insurer, which runs Blue Cross and Blue Shield plans in 14 states, has partnered with game developer Sidekick Health to create COVID Concierge Care, an app that offers members a daily symptom and outcome tracker, on-demand messaging with a clinical care manager, and articles, videos and other education information to help enrollees best manage their COVID symptoms. (Tepper, 2/15)

Modern Healthcare: ProMedica Fundraising $20M To Invest In Underserved Michigan City
Nonprofit health system ProMedica has committed to fundraising $20 million over a ten-year period to invest in a small city in Southeast Michigan to drive community development with an aim to reduce health disparities. The Toledo, Ohio-based organization has partnered with two local organizations. ... According to a press release, the main investments will center around education, housing, finance and social services, policy and community infrastructure. The funding will serve a community of approximately 11,000 people in the eastern corridor of Adrian, Michigan, which faces high levels of chronic health conditions and poverty. (Hartnett, 2/15)

San Francisco Chronicle: California Bills Target Big Tech, Rogue Doctors To Combat COVID Vaccine Misinformation
California legislators introduced a pair of bills Tuesday designed to crack down on social media platforms and rogue doctors who spread false information about COVID-19 vaccines. The measures are part of a broader package of bills that aim to fight vaccine hesitancy — unfounded fears about immunizations that public health officials say have prolonged the pandemic and increased hospitalizations and deaths from the coronavirus. (Gardiner, 2/15)

In more news from California —

San Francisco Chronicle: D.A. Chesa Boudin Drops Case Against Suspect Allegedly Linked To A Property Crime From Rape Exam DNA
San Francisco District Attorney Chesa Boudin has dismissed the property crime case against a woman whose DNA collected from a rape kit was used to link her to a recent property crime, officials said Tuesday. Officials said the case amounted to “fruit of the poisonous tree,” meaning evidence that led to the arrest was gathered in a way that violated the defendant’s rights. Boudin declined to comment on the case, citing privacy concerns. News of the dismissal comes a day after Boudin leveled a bombshell allegation that the San Francisco Police Department crime lab had used a rape victim’s DNA evidence gathered years ago to tie her to an unrelated crime. (Cassidy, 2/15)

In mental health news from Connecticut, North Carolina and Florida —

The CT Mirror: CT Senate Leaders Announce Big Children's Mental Health Bills
Senate Democrats announced on Tuesday two omnibus bills aimed at expanding children’s mental health and child care this legislative session. The initiative, titled “Healthy Students, Healthy Schools,” lays out legislative proposals being introduced through Senate Bill 1 and Senate Bill 2 to help support youth mental health, provide training to school staff, increase health services in schools and expand preschool and child care. (Watson and Carlesso, 2/15)

North Carolina Health News: NC Leaders Talk COVID Exit Strategy, Mental Health Need
Though many North Carolinians are ready to say so long to the COVID pandemic, Kody Kinsley, secretary of the state Department of Health and Human Services told lawmakers Tuesday that the state is getting closer to that point but it’s not quite there. Lawmakers on the Joint Legislative Oversight Committee on Health and Human Services encouraged Kinsley and his team to develop an exit strategy. (Blythe and Thompson, 2/16)

WUFT: Alachua County Explores Ways To Curb Reliance On ER For Mental Health Conditions 
More mental health resources, medicated-assisted treatment and increased peer specialist follow-ups after overdoses or mental health crises were among the recommendations made Friday by Alachua County's Healthcare Advisory Board Mental Health Subcommittee and Outreach and Case Management Subcommittee. Data collection by the subcommittees found increased emergency room use by residents living in ZIP codes 32609 and 32641, which span from the northeast and central parts of the [Florida] county. ER use is twice the state average in the 32609 ZIP code area and three times the state average in the 32641 area. Many of these emergency room visits are related to substance use or mental health. The committee decided to draft three action items to present to the county — education, treatment and follow-up. (Macia, 2/15)

In other health news from across the U.S. —

Mississippi Clarion Ledger: West Nile Virus: Mississippi Health Department Reports 2nd Case
A second case of West Nile virus, a mosquito-borne illness, was reported in a Hinds County resident on Tuesday. West Nile virus season typically occurs July through October. However, mosquitoes can carry the virus anytime of the year. The Mississippi State Department of Health reported the state's first 2022 case Jan. 28. The virus can cause flu-like symptoms in people who are bitten by infected mosquitoes. It can progress to be more serious, leading to meningitis or encephalitis. Since 2015, five people in Mississippi have died of the virus. (Haselhorst, 2/15)

Health News Florida: A State House Panel Backs Changes To A Bill On Nursing Home Staffing 
Florida lawmakers moved closer Monday to revamping staffing standards in nursing homes, amid criticism that the proposed changes could reduce hands-on care for residents. The debate centers on the amount of time that certified nursing assistants spend providing care to residents. Certified nursing assistants play key roles in nursing homes, but the industry says it cannot find enough of the workers — resulting, at least in some cases, to unfilled beds. (Saunders, 2/15)

AP: Wolf Official Pressed Over Fate Of 3 Elderly In Philadelphia
The head of Pennsylvania’s Department of Aging refused to tell lawmakers Tuesday whether three older adults are alive or dead, after department employees raised an alarm over how a Philadelphia agency handled the three cases of abuse or neglect. The Associated Press reported in September that those cases prompted Secretary of Aging Robert Torres to order improvements at the Philadelphia Corporation for Aging, a nonprofit with a state contract to field and respond to calls about elder abuse and neglect in the city. (Levy, 2/16)

Bloomberg: U.S. Vaccines Sent Overseas Turned Away Amid Logistics Trouble
The Biden administration says some foreign countries haven’t been able to accept their full allocation of vaccine donations from the U.S., as they increasingly grapple with logistical barriers and vaccine hesitancy. “There have been moments, yes, where countries are not able to receive the doses that we’re able to provide,” White House Press Secretary Jen Psaki said at a briefing Tuesday. She didn’t identify the countries. The U.S. has donated and shipped 437 million doses abroad so far, more than any other nation, and pledged a total of at least 1.2 billion. President Joe Biden held a virtual summit in September to muster a more coordinated global response, though advocates say that’s still lacking. (Wingrove, 2/15)

Reuters: Exclusive: Short AstraZeneca Shelf Life Complicates COVID Vaccine Rollout To World's Poorest 
The relatively short shelf life of AstraZeneca Plc's COVID-19 vaccine is complicating the rollout to the world's poorest nations, according to officials and internal World Health Organization documents reviewed by Reuters. It is the latest headache to plague the COVAX vaccine-sharing project, co-led by the WHO and aimed at getting shots to the world's neediest people. (Guarascio and Rigby, 2/16)

In other global developments —

The Hill: Canada To Ease Restrictions For Vaccinated Travelers 
Canada will be easing restrictions for fully vaccinated travelers beginning next month as the peak in new cases fueled by the COVID-19 omicron variant is believed to have passed. Beginning on Feb. 28, fully vaccinated travelers arriving into Canada will be allowed to use a rapid antigen test instead of a molecular test. Vaccinated travelers will also now be randomly selected for testing upon arrival and will not be required to quarantine while they wait for their results. (Choi, 2/15)

AP: WHO Europe Warns Of COVID Rise In East, Like Russia, Ukraine
The head of the World Health Organization’s Europe office said Tuesday that health officials are turning their attention to growing rates of COVID-19 infection in Eastern Europe, where six countries — including Russia and Ukraine — have seen a doubling in case counts over the last two weeks. (2/15)

Reuters: Omicron Surge Was More Deadly In Japan After Booster Delay, Critics Say
A Japanese government delay in rolling out COVID-19 booster shots left it more vulnerable than other rich countries when the Omicron variant brought a surge of deaths, say experts, local governments and a former vaccine czar. The issue could mean political trouble for Prime Minister Fumio Kishida as nearly 30% of the population is aged 65 or older, and so at greater risk from the coronavirus without the protection of the booster. (Swift and Lies, 2/16)

Axios: The Growing Evidence Against Drug Copay Cards 
Drug copay coupons make medications free or very cheap for patients at the pharmacy counter. But they drastically increase the amounts paid by employers, insurers and other workers, a new study conducted by a trio of health economists concludes. The study adds further evidence to the idea that drug copay cards are a great short-term deal for patients — and especially the pharmaceutical companies that promote them — but a bad long-term deal for society. (Herman, 2/15)

In other pharmaceutical industry news —

The Wall Street Journal: Altria Can Keep Its Investment In Juul, Judge Rules 
Altria Group Inc. didn’t break antitrust laws when it took a large stake in e-cigarette startup Juul Labs Inc. in 2018, an administrative law judge ruled. The Federal Trade Commission sued two years ago to unwind the deal, saying the Marlboro maker had violated antitrust laws. Chief Administrative Law Judge D. Michael Chappell, who presided over a three-week trial last summer, dismissed the FTC’s claims Tuesday, Altria said. (Maloney, 2/15)

Stat: FDA Reviewing Mirati's Lung Cancer Drug — But Taking Longer To Do It
Mirati Therapeutics said Tuesday that U.S. regulators accepted an application for its KRAS-blocking lung cancer drug, but the review time will be longer than hoped. The Food and Drug Administration granted a standard review to the Mirati drug called adagrasib, which sets the approval decision date on Dec. 14 — four months later than the company had requested. A Mirati spokesperson said the FDA did not offer the company an explanation for why adagrasib won’t be reviewed under a shortened priority review schedule. (Feuerstein, 2/15)

Stat: Some Newly Public Biotechs Are Trading Below Cash. Is It As Bad As It Looks?
More than one in four biotechs that went public in 2020 are trading below cash, according to a new STAT analysis of data from the financial database provider Sentieo. The indicator — which means a company has more cash on hand than its overall public valuation — seems like further, glaring evidence that too many biotechs raced to market in 2020, a favorite hypothesis among investors whose life science portfolios have plummeted this year. “For a company to trade below cash is like the investing equivalent of having a very bad credit score. It is a sign that investors believe you are headed towards trouble and are at a risk of being unable to create any value for your investors,” said investor Brad Loncar. (Sheridan, 2/16)

The New York Times: C.D.C. Proposes New Guidelines For Treating Pain, Including Opioid Use 
The federal government on Thursday proposed new guidelines for prescribing opioid painkillers that remove its previous recommended ceilings on doses for chronic pain patients and instead encourage doctors to use their best judgment. But the overall thrust of the recommendations was that doctors should first turn to “nonopioid therapies” for both chronic and acute pain, including prescription medications like gabapentin and over-the-counter ones like ibuprofen, as well as physical therapy, massage and acupuncture. (Hoffman, 2/10)

Axios: FTC May Probe Pharmacy Benefit Managers 
The Federal Trade Commission will vote Thursday on whether it will study how pharmacy benefit managers affect drug prices and the businesses of pharmacies. Why it matters: PBMs are powerful, secretive and heavily consolidated, and it appears the FTC is open to scrutinizing the industry that got significantly more concentrated under the FTC's own watch. (Herman, 2/14)

Stat: Akili Filings Lays Bare The Challenges Ahead For Digital Therapeutics
Akili Interactive, the maker of a Food and Drug Administration-cleared video game to treat ADHD, has long been bullish on the tremendous potential of its technology to reach wide swaths of the population. The difficulty of realizing that dream was laid bare in the company’s freshly filed paperwork as it looks to go public. In January, Akili announced that it would enter the markets via a merger with Social Capital Suvretta Holdings Corp. I, a special purpose acquisition company run by venture capitalist and former Facebook executive Chamath Palihapitiya. The deal valued the company at about $1 billion. On Monday, the companies filed an S-4 with the Securities Exchange Commission detailing the merger and giving the first good look at Akili’s finances and a thorough accounting of the hurdles that the company – and some of Akili’s competitors – could face. (Aguilar, 2/14)

Modern Healthcare: BIO Report Paints Bleak Picture Of Antibiotic Pipeline, With Some Solutions
There are a shrinking number of antibiotic drug makers and investors, who see little payoff in a market that reimburses new drugs on volume, rather than their benefits to public health, according to a new report from a trade group known as the Biotechnology Innovation Organization. About 80% of new antibiotics that are being developed in clinical trials come from small, emerging biotechnology companies, as larger manufacturers have exited the market. And, over the past decade, venture capital funding for U.S. antibiotic development was 17 times less than for oncology drugs. (Gillespie, 2/14)

CIDRAP: Launch Of First Human Trial Of Nipah Virus Vaccine Announced
Public Health Vaccines (PHV), based in Massachusetts, yesterday announced the launch of a phase 1 clinical trial for its Nipah virus vaccine, the first of its kind to be tested in people. The vaccine was developed by scientists at the National Institute of Allergy and Infectious Diseases, which licensed the product to PHV. The vaccine's development has been supported by the Coalition for Epidemic Preparedness Innovations (CEPI), which in 2017 flagged Nipah virus as one of four diseases that has the capability to trigger a major global epidemic. (2/10)

Stat: Belgium Discloses Penalties For Failing To Report Clinical Trial Results
In the latest move to crack down on wayward clinical trial sponsors, Belgium may now fine companies, hospitals, and universities that fail to publicly disclose study results, a sign that more European regulators are growing concerned about a lack of transparency surrounding medical data. As of this month, the Federal Agency for Medicines and Health Products can impose fines of $550 to $280,000 and threaten imprisonment of up to two years. The penalties, set forth in a 2017 law, did not go into effect for trial results until now because they were tied to European Union regulations that began in January. However, a new remedy adopted by the agency would permit violators to reach a settlement of at least $4,500 or otherwise face further proceedings, an FAMHP spokesperson explained. (Silverman, 2/14)

Cincinnati Enquirer: Covington Biotech Research Lab Critical To Retain Cincinnati Start-Ups
Many smaller biotechnology companies get their start in incubator labs, which allow them to rent lab and office space instead of purchasing their own equipment. But labs like these are lacking in the Cincinnati area. The city of Covington and a group of local companies are seeking to change that. Plans are in development for a new life sciences research wet lab, which would be located in Covington. (Berry, 2/14)

Axios: A Startup For Starting A Family
On this day of love, Gaia is debuting its personalized in-vitro fertilization (IVF) insurance product on the Lloyds of London market and announcing a fresh round of $20 million in Series A funding led by Atomico, the company's founder tells Axios. Why it matters: Fertility treatment is a heavily opaque sector of the health care industry that's just as convoluted as it is inequitable. Did we mention how expensive it is? (Brodwin, 2/14)

Modern Healthcare: CaptureRx Agrees To Pay $4.75M To Settle 2021 Data Breach Lawsuit
CaptureRx has agreed to pay $4.75 million to settle a proposed class-action lawsuit related to a data breach it experienced last year, according to court documents filed Friday. The settlement would end a lawsuit stemming from a hack at San Antonio-based NEC Networks, a prescription claims processor that does business under the name CaptureRx. The proposed settlement agreement, filed in a Texas district court, consolidates six lawsuits filed last year, according to a proposed order granting preliminary approval of the class-action settlement agreement. (Cohen, 2/14)

New England Journal of Medicine: Molnupiravir — A Step Toward Orally Bioavailable Therapies For Covid-19 
The Covid-19 pandemic has resulted in substantial global morbidity and mortality as well as disruption of the economies of virtually every country.1 Some of this tragedy could have been averted with the development of deliverable, orally bioavailable, direct-acting antiviral therapeutics. Molnupiravir, the orally bioavailable prodrug of N4-hydroxycytidine (NHC), begins to address this need. (Richard Whitley, M.D., 2/10)

Stat: Creating A Promising Pathway For Faster Access To New Drugs 
The FDA’s accelerated approval pathway has a potentially prominent champion — Robert Califf, the scientist President Biden has nominated to lead the FDA. This pathway opens the door to earlier approval of drugs aimed at serious conditions that fill an unmet medical need based on a surrogate endpoint, which can considerably shorten the time required to submit data to the FDA and expedite the agency’s review process. (Peter J. Pitts, 2/14)

JDSupra: OIG’s First Advisory Opinion Of 2022 Allows For Expansion Of Discount Programs 
On January 19, 2022, the Department of Health and Human Services, Office of Inspector General (“OIG”) released a favorable advisory opinion, OIG Advisory Opinion No. 22-01 (the “Opinion”), analyzing a proposed expansion of discount programs for low-income individuals. The Requestor, an owner of retail pharmacies, inquired about whether its pharmacies adding Medicaid enrollment as an eligibility category for its low-income discount program would constitute grounds for sanctions under the federal Anti-Kickback Statute (“AKS”) or the Beneficiary Inducements Civil Monetary Penalty (“CMP”) Provision. The OIG concluded that although the proposed arrangement would generate prohibited remuneration under the AKS (if the requisite intent were present) and the Beneficiary Inducements CMP Provision, the OIG would not impose administrative sanctions on Requestors in connection with the proposed arrangement. (Lisa Churvis, 2/15)

The Washington Post: Parents Of Little Kids Might Be Disappointed, But The FDA Was Right To Delay Vaccine Authorization 
The Food and Drug Administration’s announcement that it will delay authorization of a coronavirus vaccine for children under 5 felt like a gut punch. The new timeline means my two kids and about 18 million others won’t be inoculated until mid-April at the earliest, and they probably won’t be fully vaccinated until June. (Leana S. Wen, 2/15)

The Baltimore Sun: Vaccinating The Unvaccinated: An Economic Incentive May Be The Solution 
These past two years have taken a terrible toll on the world at large and the United States. In the first year of the COVID pandemic, this was overwhelmingly due to COVID-related illness and death, accompanied by health care provider burnout and very serious disparities in this country in terms of risk of infection. With the closure of innumerable workplaces and schools, there was also tremendous social and economic dislocation. At that time it was absolutely appropriate to impose a variety of restrictions on our populace, to protect as many as possible from contracting the virus, as there was very little that could be done to diminish the severity of COVID infections. (Peter Beilenson, 2/15)

New England Journal of Medicine: Covid-19 As An Endemic Disease 
The continuing spread of SARS-CoV-2 remains a Public Health Emergency of International Concern. What physicians need to know about transmission, diagnosis, and treatment of Covid-19 is the subject of ongoing updates from infectious disease experts at the Journal. (Eric J. Rubin, M.D., Ph.D., Lindsey R. Baden, M.D., and Stephen Morrissey, Ph.D., 2/10)

Stat: 4 Evolutionary Scenarios For The Coronavirus That Causes Covid-19 
In the ongoing struggle of SARS-CoV-2’s genes versus our wits, the virus that causes Covid-19 relentlessly probes human defenses with new genetic gambits. New variants of this coronavirus with increasing transmissibility have sprung up every few months, a scenario that is likely to continue. Some experts believe that the pandemic appears to be on an evolutionary slide toward becoming endemic, a “new normal” in which humans and the virus co-exist, as we currently do with influenza. But coronaviruses are clever. While an endemic resolution may be in sight, SARS-CoV-2 could still shock the human species with a devastating evolutionary leap. Here are four possible scenarios, each taken directly from the known evolutionary playbook of coronaviruses. (Donald S. Burke, 2/16)

Stat: Covid-19 Is Not A Marathon 
Do an online search for “Covid is a marathon” and the hits pile up. Even at the two-year mark, the analogies keep coming. As a marathon runner, I am here to tell you: Covid-19 is not a marathon. Marathons have discreet starts and finishes and, beginning with Phidippides, are about victories. In their current form, they celebrate athletic art authored by elite athletes. For citizen runners, they celebrate personal achievement and intentional risk taking. The extended lightning strike of Covid-19, in contrast, is something we are all subjected to. (Michael J. Joyner, 2/16)

The Atlantic: The Seven Habits Of COVID-Resilient Nations 
The tweet has stuck with me for months now: a chart of cumulative COVID-19 deaths per capita in the United States, the United Kingdom, and South Korea. The U.S. and U.K. lines rise up like mountains relative to the valley of South Korea below. Even as Omicron-related deaths have increased in South Korea more recently, the picture hasn’t changed much. South Korea “kept deaths 40 times lower all the way till 75% of population fully vaccinated,” the physician Vincent Rajkumar marveled on Twitter in response to the chart. “This is success.” (Uri Friedman, 2/15)

NBC News: Covid Began To Consume My Kids' Lives. I Had To Rethink How I Spoke To Them About It
With California’s indoor mask mandate for the vaccinated set to expire Tuesday and Gov. Gavin Newsom expected to re-evaluate guidelines for schools in two weeks, parents (and kids) are again forced to contend with a shifting Covid landscape. While the easing of some restrictions, like wearing masks outside, makes sense, I question whether the rollback of precautions is premature when case counts remain high and vaccinations are but one tool in our Covid toolkit. Then again, by now, I’m used to having to zig and zag. (Connie Chang, 2/15)

Chicago Tribune: COVID-19 Isn’t The Only Reason More People Are Dying At This Time 
In addition to sickness, suffering and death, pandemics wreak havoc in the societies they afflict. Smallpox helped destroy the Aztec Empire, and the Black Death completely changed the social fabric of Europe in the Middle Ages. Sometime early this spring, the U.S. death total for the COVID-19 pandemic will pass the 1 million milestone, but this grim number is not an accurate tally of the devastation wrought by the virus. Any comprehensive account must include other deaths, specifically those that have occurred as a result of the social disruption caused by our reaction to COVID-19. (Cory Franklin And Robert A. Weinstein:, 2/15)

The CT Mirror: FDA Must Revise Its Recommendations On Blood Donations
Just last month, the American Red Cross declared the first national blood crisis in the nation’s history. The Red Cross shockingly said “as much as one-quarter of hospital needs are not being met.” Yet, as the current policies stand, members of the LGBTQIA+ population can not give blood to help their fellow man. In its most recent recommendations, the FDA has recommended that the DHQ or Donor History Questionnaire for blood donation services include policies that “defer for 3 months from the most recent sexual contact, a man who has had sex with another man during the past 3 months” and “a female who has had sex during the past 3 months with a man who had sex with another man in the past 3 months.” (Jon Andre Parrilla, 2/16)

The Washington Post: On Helping People Hear Better, Biden Lets Markets Have Their Say 
Biden is accelerating a new Food and Drug Administration rule that will make hearing aids available over the counter, rather than only by prescription from a licensed specialist, as is now the case. He issued an executive order to that effect last July, four years after Congress passed a law authorizing such a policy, only to see the necessary regulation get bogged down in the Trump-era FDA bureaucracy. The new rule should take effect in the next few months. (Charles Lane, 2/15)

The Atlantic: Talk To The Public Like You Would Talk To A Patient 
The most effective public-health communication should embody the qualities that primary-care pediatricians like me strive to emphasize daily: empathy and nuance. We start by trying to understand families’ priorities about their children’s health and well-being. We then acknowledge ways in which the treatment may fall short, or aspects that we cannot predict. From there we lay out any potential risks and benefits with complete transparency, establish clear goals for any intervention, and support the family’s decision making with compassion. (Aparna Bole, 2/15)

Detroit News: Following The Science — Political Science, That Is 
It was never about the science.When the first COVID-19 mandates were issued in hopes of turning back a mysterious pandemic, there wasn't enough science or data available to know for certain what would work. It was all best guesses and speculation, and a desperate instinct to do something in the face of a lethal public health threat unseen in our lifetimes. (Nolan Finley, 2/13)

Stat: Welcome Back To The FDA, Robert Califf. Let's Get To Work On Your Big Idea
Now, more than ever, the U.S. needs scientific leaders who value Americans’ health and safety, who want to improve research and testing, and who are passionate about innovative ideas. With Robert Califf once again confirmed as the commissioner of the Food and Drug Administration, it’s time to actualize a powerful idea he presented during his previous tenure: make the data submitted to the FDA during the drug development process publicly available. (Elizabeth Baker and Eryn Slankster-Schmierer, 2/15)

The Tennessean: Autism From Neurodiversity View With T.A.M. McDonald
Autism has traditionally been studied from a medical perspective. Yet newer, and sometimes controversial, approaches to research are taking a new look at the autism spectrum, namely, the neurodiversity perspective. That is, shifting the "disorder" narrative that focuses on the limitations of someone with autism to looking at autism as a "valid way of being." (David Plazas, 2/15)

The Baltimore Sun: Maryland Must Move Swiftly To Regulate Harmful ‘Forever Chemicals’ 
As horrible as it was to lay to rest the three Baltimore firefighters who died fighting a fire in a vacant city rowhouse that collapsed on them last month, it should be noted that the leading cause of line-of-duty deaths of such first responders isn’t related to burns or asphyxiation or falling debris. It’s from cancer. Firefighters are routinely exposed to a host of toxic substances that can end their lives prematurely. One of the most worrisome is a class of human-made compounds called PFAS, for per- and polyfluoroalkyl substances, which have been linked to various forms of cancer and are present in some forms of firefighting foam. These “forever chemicals,” so-called because they don’t break down in the environment, but rather build up, are quite pervasive and can impact all of us. (2/15)