First Edition: Feb. 20, 2024

KFF Health News: The Powerful Constraints On Medical Care In Catholic Hospitals Across America
Nurse midwife Beverly Maldonado recalls a pregnant woman arriving at Ascension Saint Agnes Hospital in Maryland after her water broke. It was weeks before the baby would have any chance of survival, and the patient’s wishes were clear, she recalled: “Why am I staying pregnant then? What’s the point?” the patient pleaded. But the doctors couldn’t intervene, she said. The fetus still had a heartbeat and it was a Catholic hospital, subject to the “Ethical and Religious Directives for Catholic Health Care Services” that prohibit or limit procedures like abortion that the church deems “immoral” or “intrinsically evil,” according to its interpretation of the Bible. (Pradhan and Recht, 2/17)

KFF Health News: In California, Faceoff Between Major Insurer And Health System Shows Hazards Of Consolidation
For weeks, more than half a million Anthem Blue Cross enrollees who receive health care from the University of California were held in suspense. It wasn’t clear whether they would have to find new doctors or switch plans as the health system and one of its largest insurance partners struggled to reach agreement on a new contract. (Sciacca, 2/19)

The Washington Post: Alabama Supreme Court Rules Frozen Embryos Are Children, Imperiling IVF
The Alabama Supreme Court ruled Friday that frozen embryos are people and someone can be held liable for destroying them, a decision that reproductive rights advocates say could imperil in vitro fertilization (IVF) and affect the hundreds of thousands of patients who depend on treatments like it each year. The first-of-its-kind ruling comes as at least 11 states have broadly defined personhood as beginning at fertilization in their state laws, according to reproductive rights group Pregnancy Justice, and states nationwide mull additional abortion and reproductive restrictions, elevating the issue ahead of the 2024 elections. Federally, the U.S. Supreme Court will decide this term whether to limit access to an abortion drug, the first time the high court will rule on the subject since it overturned Roe v. Wade in 2022. (Rosenzweig-Ziff, 2/19)

The Hill: Alabama Supreme Court Rules Frozen Embryos Are ‘Children’
In its decision, the Alabama Supreme Court did not address the question of whether “extrauterine children” should be treated as human beings, but it did find that state law did not specify what state an unborn child is to be in. “The relevant statutory text is clear: the Wrongful Death of a Minor Act applies on its face to all unborn children, without limitation,” the court’s decision stated. The court found that there is no unwritten exception, as the defendants have argued, to the law that applies to “unborn children who are not physically located ‘in utero’ — that is, inside a biological uterus — at the time they are killed.” (Choi, 2/19)

Politico: ‘No One’s Coming To Save Us’: Abortion Campaigns Scramble For Limited Cash
Abortion rights could be on the ballot in nearly a quarter of states this November, raising concerns among supporters about the ability to fund major campaign efforts in all of them. From deep-red Arkansas and Missouri to purple Arizona and Nevada, activists are already competing with each other for a limited pool of cash and auditioning for the national progressive groups they need to fund their efforts to enshrine protections in state constitutions. (Messerly and Miranda Ollstein, 2/19)

AP: Abortion Rights Opponents And Supporters Seize On Report That Trump Privately Pushes 16-Week Ban 
A major anti-abortion group is praising a published report that Donald Trump has privately told people he supports a national ban on abortion after 16 weeks of pregnancy, though his campaign denied the report and said the former president plans to “negotiate a deal” on abortion if elected to the White House again. Trump, the frontrunner to be the 2024 Republican nominee, has repeatedly refused to back any specific limits on abortion as he campaigns, though he has called himself “the most pro-life president in American history.” (Price and Fernando, 2/16)

The New York Times: Trump Allies Plan New Sweeping Abortion Restrictions
Allies of former President Donald J. Trump and officials who served in his administration are planning ways to restrict abortion rights if he returns to power that would go far beyond proposals for a national ban or the laws enacted in conservative states across the country. Behind the scenes, specific anti-abortion plans being proposed by Mr. Trump’s allies are sweeping and legally sophisticated. Some of their proposals would rely on enforcing the Comstock Act, a long-dormant law from 1873, to criminalize the shipping of any materials used in an abortion — including abortion pills, which account for the majority of abortions in America. Lerer and Dias, 2/17)

AP: State Governments To Protect Health-Related Data As It's Used In Abortion Battle
Some state governments and federal regulators were already moving to keep individuals’ reproductive health information private when a U.S. senator’s report last week offered a new jolt, describing how cellphone location data was used to send millions of anti-abortion ads to people who visited Planned Parenthood offices. Federal law bars medical providers from sharing health data without a patient’s consent but doesn’t prevent digital tech companies from tracking menstrual cycles or an individual’s location and selling it to data brokers. (Mulvihill, 2/17)

The Washington Post: Teens Say They Use Drugs To Feel Calmer In Federal Study
Most teens who use drugs are searching for calm and hoping to relieve stress, a Centers for Disease Control and Prevention analysis suggests. The study points toward mental health challenges among teens as a driver of drug misuse — and says educating teens on harm reduction while expanding mental health treatment could reduce overdose deaths. ... Most of the adolescents in the study — 73 percent — reported using drugs and alcohol to “feel mellow, calm, or relaxed.” (Blakemore, 2/17)

The New York Times: Residents Oppose Expanding Drug Use Sites To Suburban Vancouver
British Columbia ... became the first province to decriminalize small quantities of hard drugs for personal use in 2022, about two decades after Vancouver opened the first supervised injection site in North America. ... In Richmond, one of British Columbia’s largest cities, with 230,000 people, municipal council chambers turned raucous this week as a full public gallery of residents opposed a plan for staff to study whether a safe consumption site for drug users would be viable in the community. The plan was adopted on Tuesday, but the effort is off to a rocky start, with few officials and agencies standing up to defend it. (Isai, 2/17)

Reuters: Hard Hit By The US Opioid Crisis, Oregon Reconsiders Decriminalization
It's a common sight on the streets of downtown Portland, Oregon: people in front of stores, trendy restaurants and hotels, on sidewalks, corners, and benches, crouched over torch lighters held up to sheets of tinfoil or meth pipes. Some drape blankets over their heads, or duck behind concrete barriers. Others don’t try to hide. "All summer long, we were right out in the open. You didn't have to be paranoid anymore, you didn't have to be worried about the cops," said John Hood, a 61-year-old drug addict living on the streets of Oregon’s most populous city. (Bloom, 2/18)

Stat: Opioid Cravings Were Reduced By Anti-Obesity Drug In Small Study
The GLP-1 medication liraglutide significantly reduced opioid cravings in a small analysis presented on Saturday. It is the first randomized controlled trial to test anti-obesity drugs against opioid addiction, which kills around 80,000 people in the U.S. each year. (Bajaj, 2/17)

The Hill: Largest Multicountry COVID Study Links Vaccines To Potential Adverse Effects
A new study on COVID-19 vaccines that looked at nearly 100 million vaccinated individuals affirmed the vaccines’ previously observed links to increased risks for certain adverse effects including myocarditis and Guillain-Barré syndrome. The study was conducted by the Global COVID Vaccine Safety project and took into account 99,068,901 vaccinated individuals across eight countries: Argentina, Australia, Canada, Denmark, Finland, France, New Zealand and Scotland. (Choi, 2/19)

CIDRAP: Canadian Data Show Moderate To Good Vaccine Efficacy Against COVID, Flu
The Canadian Sentinel Practitioner Surveillance Network (SPSN) data reveal mid-season vaccine effectiveness (VE) against the SARS-CoV-2 Omicron XBB.1.5 variant of 47% against medically attended outpatient COVID-19 and 67% among previously infected people. The same test-negative case-control study reports that the flu vaccine is 63% effective against medically attended outpatient infection with the influenza A H1N1 strain and 40% against H3N2. (Van Beusekom, 2/19)

The Washington Post: CDC Easing Covid Isolation Guidance Worries Vulnerable People
Concerns among medically vulnerable people are growing as the Centers for Disease Control and Prevention prepares to drop its long-standing recommendation that those with covid isolate for five days. People with compromised immune systems worry that co-workers will return to the office while they’re still contagious. At the same time, the few remaining policies guaranteeing paid leave for employees with covid are largely coming to an end. New York, the only state that still requires paid leave for covid isolation, is considering ending that benefit this summer. (Nirappil and Sun, 2/17)

The Hill: House COVID Panel Leader Threatens To Subpoena HHS For Lack Of Cooperation
The chair of the House panel investigating the COVID-19 pandemic threatened to subpoena Department of Health and Human Services (HHS) officials Friday over a lack of cooperation with the committee’s investigation unless they answer another round of specific questions. In a letter sent to HHS Assistant Secretary for Legislation Melanie Egorin, Rep. Brad Wenstrup (R-Ohio) expressed frustration with Egorin’s recent public testimony and what he said was a persistent lack of cooperation from the agency on producing documents related to the virus’s origins, vaccine messaging and policies about COVID closures. (Weixel, 2/16) 

Politico: Red States Hopeful For A 2nd Trump Term Prepare To Curtail Medicaid
Republicans in half a dozen states have a request for a second Trump administration: Require low-income adults to work for free government health care. In places like Idaho, Missouri and South Dakota, GOP officials are laying the groundwork to substantially overhaul their health safety-net programs. Their plans, if approved by a Trump White House, could cut hundreds of thousands of people from a program that conservatives have long complained is bloated — but the move could also save states and the federal government billions of dollars. (Messerly, 2/20)

AP: US Lawmakers Raise Alarms About Failure To Compete With China In Biotechnology
U.S. lawmakers are raising alarms about what they see as America’s failure to compete with China in biotechnology, warning of the risks to U.S. national security and commercial interests. ... Biotechnology promises to revolutionize everyday life, with scientists and researchers using it to make rapid advances in medical treatment, genetic engineering in agriculture and novel biomaterials. Bills have been introduced in the House and Senate to bar “foreign adversary biotech companies of concern” from doing business with federally funded medical providers. The bills name four Chinese-owned companies. (Tang, 2/19)

AP: FDA Expands Use Of Asthma Drug Xolair To Treat Severe Food Allergies
A medication used to treat asthma can now be used to help people with food allergies avoid severe reactions, the U.S. Food and Drug Administration said Friday. Xolair, the brand name for the drug omalizumab, became the first medication approved to reduce allergic reactions caused by accidental exposure to food triggers. Patients as young as age 1 with allergies can take the drug by injection every two to four weeks, depending on their weight and their body’s response to allergens. (Aleccia, 2/16)

The Hill: FDA Approves First Cellular Therapy To Treat Advanced Melanoma
“Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research (CBER), said in a press release. “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.” Amtagvi was approved under an accelerated pathway — reserved for serious or life-threatening illnesses when other therapies don’t work. (Suter, 2/17)

Reuters: US FDA Grants Accelerated Approval For Iovance's Skin Cancer Cell Therapy
Iovance Biotherapeutics (IOVA.O), opens new tab said on Friday the U.S. health regulator has granted an accelerated approval for its cell therapy for adult patients with advanced melanoma, the first such treatment to be approved for the deadliest form of skin cancer. The agency's greenlight for the first cell therapy targeting a solid tumor allows use in patients who have been previously treated with other therapies, but their cancer has spread to other parts of the body, and cannot be removed with surgery. (Jain, 2/17)

Reuters: U.S. FDA Approves AstraZeneca's Tagrisso-Chemo Combo
A combination of AstraZeneca's(AZN.L), opens new tab blockbuster cancer drug Tagrisso with chemotherapy to treat a type of lung cancer has been approved by the U.S. Food and Drug Administration (FDA), the company said in a statement on Friday. The drug would be used to treat adults with a type of advanced lung cancer, AstraZeneca said, adding that the FDA's approval was based on trials which extended median progression-free survival (PFS) by nearly nine months. (2/17)

The Hill: Maternal Syphilis Rates Tripled Between 2016 And 2022: CDC
The number of expecting mothers with syphilis in the United States more than tripled between 2016 and 2022, according to a recent Centers for Disease Control and Prevention (CDC) study. Between those years, the overall rate of syphilis among pregnant women in the country increased from 87.2 per 100,000 births to 280.4 per 100,000 births. Syphilis cases have risen to levels not seen since the 1950s among the U.S. general population, according to the CDC. Cases of the bacterial infection have gone up by 17 percent in the last year and by 80 percent over the past five years. (O'Connell-Domenech, 2/16)

The Hill: Florida Health Officials Investigate Measles Outbreak At School
The Florida Department of Health is investigating a measles outbreak at a South Florida elementary school. The Florida Department of Health in Broward County announced Sunday it is investigating four cases confirmed at Manatee Bay Elementary School in Weston, according to CBS News. The first case was reported Thursday and three others were confirmed Saturday. (Delandro, 2/19)

CIDRAP: CDC Announces E Coli Outbreak Tied To Raw Milk Cheese, More Charcuterie Salmonella Cases
At least 10 people in four states have been infected with pathogenic Escherichia coli in an outbreak tied to cheese made from raw milk by Raw Farm LLC, the Centers for Disease Control and Prevention (CDC) confirmed late last week, and a day earlier the agency reported 40 more Salmonella illnesses in a 30-state outbreak linked to charcuterie meats. (Wappes, 2/19)

CIDRAP: Dengue Activity In The Americas Already Outpacing Last Year's Surge
After record dengue activity in 2023 in the Americas, the brisk pace of new infections showed no let-up in the first 5 weeks of the new year, with 11 countries reporting rising cases and Brazil among the hardest-hit nations.In its latest epidemiologic alert, the Pan American Health Organization (PAHO) said cases have increased 157% compared to the same period in 2023 and are 225% above the 5-year average. (Schnirring, 2/19)

Stat: New Study Raises Questions About Niacin And Heart Health
Niacin, or vitamin B3, has long been a U.S. public health darling to the point that it is added, by law, to cereal products. But a new study published Monday in Nature Medicine points to a potentially concerning effect of an excess of the vitamin: It may increase the risk of cardiovascular disease. (Merelli, 2/19)

Newsweek: Too Much Vitamin B3 May Up Heart Attack And Stroke Risk
Niacin, also known as vitamin B3, is a water-soluble B vitamin found in meat, fish, nuts, legumes, brown rice and fortified cereals. Its main role in the body is as an assistant to our cell's molecular machines, helping convert sugar into energy, create and repair DNA, remove dangerous metabolic waste products and build healthy fats and "good" cholesterol. ... In a study, published in the journal Nature Medicine, the team, led by Stanley Hazen, analyzed blood plasma samples from 4,325 people from across the U.S and Europe. From these blood samples, the team found that the presence of two molecules, produced by the breakdown of excess vitamin B3, was associated with an increased risk of major adverse cardiovascular events. (Dewan, 2/19)

Newsweek: Scientists Create Lab-Grown Testicles
A pair of tiny artificial testicles have been created in a lab, which scientists hope will provide solutions to male infertility and improve our understanding of testicular development and function. Roughly 1 in 12 men of reproductive age in the United States have experienced problems with infertility. But while male infertility can be easily identified, we know very little about the actual causes behind this condition. (Dewan, 2/19)

Reuters: Pfizer Inflammatory Bowel Disease Drug Wins EU Approval
Pfizer's (PFE.N), opens new tab drug to treat patients with an inflammatory bowel disease called ulcerative colitis has been approved by the European Commission, the company said on Monday. The approval for Velsipity follows backing from the European Medicines Agency's panel of experts in December, opens new tab. The drug was approved for use in patients aged 16 or older and who did not show adequate response or were intolerant to previous treatment, Pfizer said. (2/19)

Reuters: EU Drug Regulator To Review Lilly's Mounjaro In Multi-Dose Pen
The European Union's healthcare regulator will this week review the use of Eli Lilly's (LLY.N), opens new tab approved Mounjaro drug against diabetes and obesity when prefilled in a multi-dose injection pen, according to a meeting agenda, opens new tab posted on the watchdog's website on Monday. The U.S. drugmaker won EU approval for the weekly injection late last year and has initially made starter doses available in member states Germany and Poland packaged in vials, so that patients need to draw the medication into syringes before injection. (Burger, 2/19)

CIDRAP: Most Mycoplasma Genitalium Isolates In Belgium Macrolide-Resistant
More than half of sequenced samples of Mycoplasma genitalium (MG) in Belgium were resistant to macrolides, researchers reported last week in Eurosurveillance. From July to November 2022, a team led by researchers with the National Reference Centre of Sexually Transmitted Infections Belgium analyzed a collection of frozen MG-positive samples from 21 Belgian laboratories. MG is a sexually transmitted bacterium that can cause symptomatic and asymptomatic urethritis in men and has been associated with cervicitis in women. (Dall, 2/19)

Stat: Researchers Tackle Phage Therapy Hurdles For Wider Adoption
Lynn Cole was in a never-ending cycle of getting recurrent blood infections. And no antibiotic drugs managed to kill off her zombie-like bacteria. “It just got so frustrating over the years because we couldn’t find the source, so we couldn’t figure out how to treat it and prevent it from happening,” said Mya Cole, Lynn’s daughter. Lynn would be in and out of the hospital. And because she had Sjogren’s syndrome — an autoimmune disease — her health continued to deteriorate. (Balthazar, 2/20)

Reuters: US Study Uncovers 275 Million Entirely New Genetic Variants
A study that analyzed the genetic code of a quarter of a million U.S. volunteers found more than 275 million entirely new variants that may help explain why some groups are more prone to disease than others, researchers reported on Monday. The whole genome sequencing data from a wide range of Americans aims to address the historical lack of diversity in existing genomic datasets by focusing on previously under-represented groups. The U.S. National Institutes of Health-funded "All of Us" study turned up 1 billion genetic variants in total. (Steenhuysen, 2/19)

Stat: Non-Europeans Account For Half The DNA Sequenced By All Of Us
Six years ago, the National Institutes of Health placed its biggest ever bet on precision medicine, launching a study to enroll over 1 million participants in an ambitious data-gathering gambit unmatched in its scope and diversity. Since then, Americans from all walks of life have been showing up and handing over their blood, spit, and pee to the project, dubbed “All of Us.” From those samples, scientists have recovered a trove of new genetic information — more than 275 million never-before-seen DNA variants. (Molteni, 2/19)

Modern Healthcare: How CMS’ Rule Could Tighten Accrediting Organization Oversight
Accrediting organizations may have to reduce their fee-based consultation services and prohibit survey participation for employees with ties to health facilities or face penalties for violating conflict-of-interest provisions if the Centers for Medicare and Medicaid Services sticks with recent oversight proposals. CMS proposed a rule to hike oversight of those organizations Feb. 8 in response to concerns about the integrity of accrediting bodies and the quality of the facilities they survey. (Devereaux, 2/20)

Modern Healthcare: Why Digital Health Funding Is Drying Up In 2024
Three years after digital health companies received a record $29.1 billion into venture capital funds, they face a far different reality in 2024: trying to raise enough capital in a tight market to stay solvent. Venture capital investors say many founders are taking bridge rounds, interim funding meant to help startups stay afloat between larger funding rounds. (Turner, 2/20)

Reuters: Dialysis Firm FMC Sees Robust 2024 Earnings Growth After Strong Q4
Fresenius Medical Care (FMEG.DE), opens new tab on Tuesday forecast its core earnings to grow by a mid- to high-teens percentage this year, after the German dialysis specialist's fourth-quarter earnings topped market expectations. Last year, the company's adjusted operating income increased by 15% to 1.7 billion euros ($1.83 billion). "Based on the turnaround progress achieved last year, we have a strong foundation to build on to make 2024 a year of accelerated profitable growth," CEO Helen Giza said. (2/20)

Reuters: Bayer Cuts Dividends To Legal Minimum To Reduce Debt
German drugmaker Bayer (BAYGn.DE), opens new tab said on Monday that it was amending its dividend policy to pay the legal minimum for a period of three years to reduce debt, in a decision it said it did not take lightly. The company said it was facing high debt and interest rates, as well as a "challenging free cash flow situation". "One of our top priorities is reducing debt and increasing flexibility," Chief Executive Bill Anderson said. (2/19)

Reuters: US FDA To Review Sarepta's Duchenne Gene Therapy For Traditional Approval
Sarepta Therapeutics (SRPT.O), opens new tab said on Friday that the US FDA would review an application seeking traditional approval for its gene therapy to treat a muscle-wasting disorder by June 21, months after it failed the main goal of a confirmatory trial. Shares of the company rose nearly 11% in morning trading. They briefly fell in October after data from the confirmatory study, but have recovered losses since then. (2/16)

AP: Missouri House Votes To Ban Celebratory Gunfire Days After Chiefs' Parade Shooting
Missouri’s Republican-led House on Monday passed a bill to ban celebratory gunfire in cities less than a week after a deadly shooting at the Kansas City Chiefs’ Super Bowl parade left some attending lawmakers hiding in bathrooms. Kansas City police have said the shooting appeared to stem from a dispute between several people and not celebratory gunfire. ... But the largely bipartisan-supported bill on celebratory gunfire represents a rare effort to regulate guns in a state with some of the most expansive laws on firearm ownership. (Ballentine, 2/20)

AP: Louisiana Governor Urges Lawmakers To Pass Tough-On-Crime Legislation
As Louisiana’s crime-focused special legislative session kicked off Monday afternoon, Republican Gov. Jeff Landry urged the GOP-dominated Legislature to pass tough-on-crime policies, assuring lawmakers that he would sign the bills into law. Among the legislation on this short session’s agenda are proposals to expand methods to carry out death row executions, restrict parole eligibility, create harsher penalties for carjackings, allow concealed carry of firearms without a permit, give law enforcement officers “immunity from liability,” and lower the age of when someone charged with a felony can be tried as an adult to 17. (Cline, 2/20)