First Edition: December 21, 2023

KFF Health News: Deep Flaws In FDA Oversight Of Medical Devices, And Patient Harm, Exposed In Lawsuits And Records
Living with diabetes, Carlton “PeeWee” Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream. The pump, manufactured by device maker Medtronic, connected plastic tubing to an insulin reservoir, which Gautney set to release doses of the vital hormone over the course of the day. Gautney, a motorcycle enthusiast, worked as a dispatcher with the police department in Opp, Alabama. (Schulte and Hacker, 12/21)

KFF Health News: The Year In Opioid Settlements: 5 Things You Need To Know
This year, about $1.5 billion has landed in state and local government coffers from court settlements made with more than a dozen companies that manufactured, sold, or distributed prescription painkillers and were sued for their role in fueling the opioid crisis. That money has gone from an emerging funding stream for which people had lofty but uncertain aspirations to a coveted pot of billions of dollars being invested in real time to address addiction. (Pattani, 12/21)

KFF Health News: Inside The Pentagon’s Painfully Slow Effort To Clean Up Decades Of PFAS Contamination
Oscoda, Michigan, has the distinction as the first community where “forever chemicals” were found seeping from a military installation into the surrounding community. Beginning in 2010, state officials and later residents who lived near the former Wurtsmith Air Force Base were horrified to learn that the chemicals, collectively called PFAS, had leached into their rivers, lakes, and drinking water. (Norman and Kime, 12/21)

Reuters: Enrollment For 2024 Obamacare Plans 33% Higher Than Last Year
Consumers who enroll before the deadline will have coverage that starts from Feb. 1, 2024. Those who want to be covered as of Jan. 1 would have had to choose a plan by Dec. 15. Data released by the U.S. Department of Health and Human Services earlier this month showed nearly 7.3 million Americans had signed up for health insurance so far for next year through the ACA marketplace. (12/20)

Politico: Obamacare Signups On Record-Setting Pace For 2024
More than 19 million people are set to have an Obamacare insurance plan next year, shattering 2023’s record 16.3 million enrollment. The Biden administration announced Wednesday that as of Dec. 15 more than 15.3 million people have signed up for a plan under the Affordable Care Act through the HealthCare.gov website. HHS projects another roughly 4 million have enrolled through state-run marketplaces as of Dec. 9. (King, 12/20)

The Washington Post: 12 States Where The Fate Of Abortion Rights Could Be On 2024 Ballots 
Voters in about a dozen states in 2024 could decide the fate of abortion rights with constitutional amendments on the ballot in a pivotal election year — including in several battlegrounds that will be key to deciding the presidential race and which party controls Congress. (Wang and Ann Caldwell, 12/20)

The Hill: Backers Say Florida Abortion Ballot Initiative On Track Ahead Of Signature Deadline
A coalition of abortion rights groups in Florida says it is close to collecting enough signatures to put a constitutional amendment on the ballot next year that would protect abortion. By the end of the month, Floridians Protecting Freedom said it will have submitted 1.4 million signatures to state officials, more than enough to qualify ahead of the Feb. 1 deadline to get signatures submitted and verified. (Weixel, 12/20)

AP: Ohio Prosecutor Says He's Duty Bound To Bring Miscarriage Case To A Grand Jury
An Ohio prosecutor says it is not within his power to drop a criminal charge against a woman who miscarried in the restroom at her home, regardless of the pressure being brought to bear by the national attention on her case. Trumbull County Prosecutor Dennis Watkins said in a release issued late Tuesday that he is obligated to present the felony abuse-of-corpse charge against Brittany Watts, 33, of Warren, to a grand jury.“ (Carr Smyth, 12/20)

CNN: Emergency Contraception Sales Spike After New Year’s, Study Finds
Sales of emergency contraception in the United States may spike by around 10% following New Year’s celebrations, according to a new study that found the trend has occurred over the past several years. (Rogers, 12/20)

AP: Homeless Numbers In Los Angeles Could Surge Again
In the hours after being elected mayor of Los Angeles, Karen Bass made a promise that will be an inescapable metric of her time in office: “We are going to solve homelessness.” The Democratic member of Congress, who had been on then-candidate Joe Biden’s short list for vice president, envisioned streets clear of more than 40,000 homeless people — a broken city within a city — and the expansion of housing and health services that would repair troubled lives. (Blood, 12/21)

The Wall Street Journal: Midsize Cities Struggle With Snowballing Homelessness
Firefighters and mental-health workers set out before dawn in this west Michigan city one November morning, rousing people sleeping on the streets before businesses open and seeing if any need help. Firefighter Mike Waldron spoke to two people sleeping above a steam vent outside a smoothie shop and returned to the group’s van. (Najmabadi and Kamp, 12/20)

The Washington Post: Dozens Died Homeless In D.C. This Year Amid Homelessness Spike
Unhoused people and their advocates marched through downtown Washington Wednesday in an annual vigil to honor those who died homeless in the District in the past 12 months. There were many to remember. At least 77 homeless people have died in D.C. this year, according to city’s medical examiner. They fell prey to intoxication, accidents and homicides amid a record increase in homelessness across the nation. (Moyer, 12/20)

AP: Homeless People Who Died On US Streets Are Increasingly Remembered At Winter Solstice Gatherings
With his gap-tooth smile, hip-hop routines and volunteer work for a food charity, Roosevelt White III was well known in the downtown Phoenix tent city known as “The Zone.” But like many homeless people, White suffered from diabetes and cardiovascular disease. He died unexpectedly one sweltering September day at age 36. (Snow, 12/21)

The New York Times: U.S. Regulators Propose New Online Privacy Safeguards For Children
The Federal Trade Commission on Wednesday proposed sweeping changes to bolster the key federal rule that has protected children’s privacy online, in one of the most significant attempts by the U.S. government to strengthen consumer privacy in more than a decade. The changes are intended to fortify the rules underlying the Children’s Online Privacy Protection Act of 1998, a law that restricts the online tracking of youngsters by services like social media apps, video game platforms, toy retailers and digital advertising networks. Regulators said the moves would “shift the burden” of online safety from parents to apps and other digital services while curbing how platforms may use and monetize children’s data. (Singer, 12/20)

The New York Times: Supreme Court Will Consider Hold On Biden’s Air Pollution Plan
The Supreme Court announced on Wednesday that it would hear arguments in February on whether it should temporarily stop the Biden administration from requiring factories and power plants in Western and Midwestern states to cut air pollution that drifts into Eastern states. The court’s brief order did not suspend the program in the meantime or add the case to the court’s merits docket. Oral arguments in cases that reach the court by way of an emergency application, as in this case, are quite rare. (Liptak, 12/20)

The New York Times: Kendra’s Law Was Meant To Prevent Violence. It Failed Hundreds Of Times
After John Skeene served prison time for beating his mother to death with a chair leg, after he attacked a man with a radiator cover and threatened to murder his therapist, New York State placed him in its gold-standard program for treating mentally ill people at risk of committing violence. The program, which grew out of legislation known as Kendra’s Law and has been held up as a national model, was supposed to ensure that Mr. Skeene complied with a court-ordered treatment plan despite being homeless and living with schizoaffective disorder. (Julia Harris and Ransom, 12/21)

Politico: House Dems Call For Hearing On Heat-Related USPS Injuries
House Oversight and Accountability Committee Democrats are pushing the panel to investigate whether the U.S. Postal Service is doing enough to protect employees from extreme heat. In a letter sent Tuesday to Chair James Comer (R-Ky.), 14 Democrats said they were "troubled by reports of unsafe working conditions driven by extreme heat and inadequate workplace safety procedures." (Alvey, 12/20)

Politico: FAA Creates New Panel To Focus On Air Traffic Controller Fatigue
The FAA said Wednesday that it is creating a new panel of experts to review fatigue issues across its air traffic controller workforce. The three-member panel “will examine how the latest science on sleep needs and fatigue considerations could be applied to controller work requirements and scheduling,” the FAA said on Wednesday. Those experts aim to identify potential ways the FAA “could better address” fatigue among its controllers. The study will also review previous controller fatigue research, the agency said. (Pawlyk, 12/20)

Politico: Artificial Intelligence Is Already In Use At HHS
As Washington scrambles to regulate artificial intelligence in health care, the Department of Health and Human Services already uses the technology in its day-to-day work — and expects AI to play a larger role over the next several years. HHS is one of the top agencies using AI — fourth only to NASA and the Departments of Commerce and Energy — according to a recent Government Accountability Office report which looked at implemented or planned AI uses reported by department. (Cirruzzo, 12/20)

Reuters: US FDA Identifies Recall Of Philips Medical Imaging Devices As Most Serious
The U.S. Food and Drug Administration (FDA) on Wednesday classified the recall of Philips' (PHG.AS) medical imaging devices as most serious as their use could cause serious injuries or death. The company's U.S.-listed shares were down about 1%. Philips was recalling some models of the Panorama 1.0T HFO device in the U.S. due to risk of explosion during a "quench procedure" caused by excessive buildup of helium gas. (12/20)

The Hill: Top Biden Officials Meet With Black, Public Health Leaders Following Menthol Ban Delay
Top Biden administration officials this week met with prominent civil rights and public health leaders in the wake of the administration’s decision to delay a ban on menthol cigarettes. The unannounced meeting was not formally on the public schedule, but it followed a similar call officials had last month with tobacco industry lobbyists — including former lawmakers — who advocated against the proposed ban. (Weixel, 12/20)

Reuters: Juul Seeks US Authorization For Its New Age-Restricted Menthol Pods
Juul Labs said on Tuesday it was seeking U.S. authorization for its new menthol-flavored pods, which require user age verification, to be used with its e-cigarette device that is under review by regulators. Juul's e-cigarettes were briefly banned in the U.S. in June 2022 after the U.S. Food and Drug Administration (FDA) concluded the company had failed to show that the sale of its products would be appropriate for public health. Following an appeal, the health regulator put the ban on hold and agreed to an additional review of Juul's marketing application. (12/20)

AP: Parents Of Kids Sickened By Lead-Linked Fruit Pouches Fear For Future
When Cora Dibert went for a routine blood test in October, the toddler brought along her favorite new snack: a squeeze pouch of WanaBana cinnamon-flavored apple puree. “She sucked them dry,” recalls her 26-year-old mother, Morgan Shurtleff, of Elgin, Oklahoma. Within a week, the family got an alarming call. The test showed that the 1-year-old had lead poisoning, with nearly four times as much lead as the level that raises concern. Only later did Shurtleff learn that that the fruit puree Cora’s grandmother bought at a Dollar Tree store may have been the cause. (Aleccia, 12/20)

Los Angeles Times: Thousands Overdosed On Ozempic, Wegovy In 2023
Some of those taking Ozempic or Wegovy are learning that too much of a good thing is never good. ... Between Jan. 1 and Nov. 30 this year, at least 2,941 Americans reported overdose exposures to semaglutide, according to a recent report from America’s Poison Centers, a national nonprofit representing 55 poison centers in the United States. ... The nationwide number of semaglutide overdoses this year is more than double the 1,447 reported in 2022, which was more than double the 607 semaglutide overdoses reported in 2021. (Childs, 12/20)

CIDRAP: Most COVID Patients Received Antibiotics Early In The Pandemic, Data Show 
Nearly 80% of COVID-19 patients in 28 countries received early empiric antibiotics during the first year and a half of the pandemic, US and Turkish researchers reported yesterday in the International Journal of Infectious Diseases. (Dall, 12/20)

CIDRAP: Long COVID Changes Heart Rate Variability, Study Suggests
According to a small case-control study today in Scientific Reports, long COVID can affect heart rate variability (HRV) at rest and during deep breathing, adding to the evidence that persistent symptoms of the virus can be associated with cardiac and dysfunction of the autonomic nervous system (dysautonomia). This system regulates involuntary functions like heartbeat, blood pressure, and sweating. (Soucheray, 12/20)

CIDRAP: COVID Contact-Tracing Study Suggests Length Of Exposure Biggest Factor In Disease Spread 
An analysis of 7 million contacts of COVID-19 patients in the United Kingdom estimates that most transmissions resulted from exposures lasting 1 hour to several days and that households accounted for 40% of spread from spring 2021 to early 2022. A team led by University of Oxford researchers evaluated data from the National Health Service (NHS) COVID-19 contact-tracing smartphone app in England and Wales to estimate how well app measurements correlated with real-life transmissions. (Van Beusekom, 12/20)

CIDRAP: Study Highlights Factors Linked To Inappropriate Antibiotics In Kids
Ear infections, a general practitioner (GP) as a prescriber, and rural settings were identified as primary drivers of inappropriate antibiotic prescribing in children treated in ambulatory care in high-income countries, according to a study published yesterday in the Journal of Antimicrobial Chemotherapy. (Dall, 12/20)

Axios: AI Guardrails Can Fall Short In Health Care: Study
When physicians use artificial intelligence tools with baked-in systemic bias to help figure out what's wrong with patients, it's perhaps little surprise they're apt to make less accurate diagnoses. But a common safeguard against potential bias — transparency about how the AI came to form its predictions — doesn't help mitigate that problem, a new JAMA study finds. (Reed, 12/20)

Fox News: Sleeping Longer During The Weekend Could Help Keep Heart Attacks At Bay, Study Finds
Catching up on shuteye over the weekend could provide the bonus of improved cardiovascular health, according to a new study published in the journal Sleep Health. Researchers from Nanjing Medical University in China analyzed data from the National Health and Nutrition Examination Survey (NHANES), which compiled information from 3,400 U.S. adults ages 20 years and older between 2017 and 2018. ...The people who slept for at least one hour longer on weekends than weekdays were shown to have lower rates of cardiovascular disease. (Rudy, 12/20)

The Wall Street Journal: FDA Says Merck’s Chronic Cough Treatment Didn’t Show Substantial Evidence Of Effectiveness
Merck’s candidate to treat chronic cough didn’t show substantial evidence of effectiveness, according to the Food and Drug Administration. The Rahway, N.J.-based pharmaceutical company said Wednesday it received a complete response letter from the FDA regarding its new drug application for gefapixant, a potential treatment for refractory chronic cough or unexplained chronic cough in adults. (Glickman, 12/20)

Reuters: US FDA Declines To Approve Merck's Chronic Cough Drug
The U.S. Food and Drug Administration (FDA) declined to approve Merck's (MRK.N) drug for chronic cough, the company said on Wednesday, marking the second rejection in less than two years. The health regulator concluded the company's application for the drug, gefapixant, did not meet substantial evidence of effectiveness for treating refractory chronic cough and unexplained chronic cough. Currently, there are no approved treatments in the United States for coughing bouts that don't go away despite treatment of underlying conditions or have no identifiable cause. (12/20)

Reuters: US FDA Approves Sweden-Based Calliditas' Kidney Disease Drug
The U.S. Food and Drug Administration (FDA) granted full approval to Swedish drugmaker Calliditas Therapeutics' (CALTX.ST) drug to treat rare kidney disease IgA Nephropathy (IgAN), the company said on Wednesday. The company's U.S.-listed shares rose 29% after the bell. The FDA decision makes the drug, branded as Tarpeyo, the first to be granted a full approval in the United States for IgAN, ahead of Travere Therapeutics' (TVTX.O) Filspari which won accelerated approval earlier this year. (Sunny and Santhosh, 12/20)

Stat: In Another Setback, Argenx Drug Fails Trial In Skin Blistering Condition
The Belgian company Argenx said Wednesday that its closely watched antibody therapy failed to outperform placebo in a Phase 3 trial in an autoimmune condition that causes the skin to blister — the second setback in less than a month for the biotech and its drug. (Joseph, 12/20)

Modern Healthcare: Fitch: Healthcare Hiring, Retention Rates Growing
Hospital employment numbers have increased, while healthcare job openings are on the decline—though the industry is still recovering from the effects of the COVID-19 pandemic. About 17.2 million individuals were on the payroll at healthcare organizations in November 2023, compared with 16.6 million in December 2022, according to the latest data from the Bureau of Labor Statistics. (Devereaux, 12/20)

Modern Healthcare: Final Merger Guidelines May Limit M&A
Federal regulators subtly changed the final merger guidelines this week as the agencies outlined their plan to limit consolidation in all industries, including healthcare. The updated guidelines from the Federal Trade Commission and Justice Department could have a wide-ranging impact on many types of deals, including cross-market health system mergers and acquisitions of physician practices by hospitals and insurers. (Kacik, 12/20)

AP: Health Officials Push To Get Schoolchildren Vaccinated As More US Parents Opt Out
When Idaho had a rare measles outbreak a few months ago, health officials scrambled to keep it from spreading. In the end, 10 people, all in one family, were infected, all unvaccinated. This time, the state was lucky, said the region’s medical director Dr. Perry Jansen. The family quickly quarantined and the children were already taught at home. The outbreak could have been worse if the kids were in public school, given the state’s low vaccination rates, he said. (Shastri, 12/20)

AP: Judge Weighs Request To Stop Nation's First Execution By Nitrogen, In Alabama
A federal judge heard diverging arguments Wednesday about the humaneness and risks of execution by nitrogen gas as he weighs whether to let Alabama attempt the nation’s first use of the method. Attorneys for Kenneth Eugene Smith are asking a judge to block his Jan. 25 execution by nitrogen hypoxia. They argued that the method violates the constitutional ban on cruel and unusual punishment and said the mask, which is fitted seal over his nose and mouth, would interfere with his ability to pray with his spiritual adviser. (Chandler, 12/21)

Politico: ‘A Fiefdom’: One Brooklyn Health Board Sued Over CEO’s Ouster
A member of One Brooklyn Health’s board is suing chair Alexander Rovt, a billionaire businessperson and major political donor in New York, over a recent vote to oust the hospital network’s chief executive. The yet-to-be-reported petition , which was filed by board member Maurice Reid and former State Assemblymember Annette Robinson, accuses Rovt of breaching his fiduciary duties by making “reckless” and false statements maligning One Brooklyn Health CEO LaRay Brown in an interview with POLITICO in September and “lavishing expensive perks” on fellow board members. (Kaufman, 12/20)

State House News: PFAs Exposure: Massachusetts Lawmakers Urge Legal Action
Nearly half of the Legislature signed onto a letter to Attorney General Andrea Campbell this week, imploring the state to join Worcester firefighters diagnosed with cancer in their lawsuit against companies that make firefighting gear alleged to include toxic PFAS chemicals. “Our firefighters place themselves in harm’s way to protect the Commonwealth’s residents and property. In doing so, they utilize gear, procured by the government, with the expectation that the gear will help protect them from harm." (Young, 12/20)

The Colorado Sun: Officials Confirm First Case Of Measles In Colorado Resident In Five Years
Colorado officials have confirmed the first case of measles in a state resident in five years. The patient is an adolescent who traveled abroad to several countries, returning to Denver International Airport on Dec. 13, according to the state health department. It’s the first confirmed measles case in a Colorado resident since January 2019. (Brown and Ingold, 12/20)