From Washington, DC,

• The Hill reports,
  • “Congress has just 10 days until government funding is set to run out, and lawmakers don’t have a deal to keep the lights on during the holidays.
  • “Members on both sides of the aisle expect the government will stay open past the Dec. 20 shutdown deadline. But negotiators are keeping their colleagues guessing about how that will be achieved as funding talks enter a critical stretch.” * * *
  • “Lawmakers are expecting leadership to land on a stopgap that runs through sometime next March, although some Republicans in both chambers have pushed for a CR that ends sooner to push Congress to finish up its funding work faster. 
  • Others are also concerned about taking up too much of President-elect Trump’s first months in office on finalizing fiscal 2025 spending bills.” 

• The American Hospital Association News tells us,
  • “The Department of Health and Human Services Dec. 10 amended the Public Readiness and Emergency Preparedness Act declaration for COVID-19, extending liability protections for certain COVID-19 countermeasure activities through 2029. Among other changes, the protections apply to all medical countermeasure activities provided through a federal agreement, as well as to pharmacists, pharmacy interns and pharmacy technicians who administer COVID-19 and seasonal flu vaccines and COVID-19 tests. These protections apply regardless of a federal agreement or emergency declaration.”
    
• Per a Health and Human Services press release,
  • “The Scientific Report of the 2025 Dietary Guidelines Advisory Committee is now available on DietaryGuidelines.gov. The report contains the 2025 Dietary Guidelines Advisory Committee’s (Committee) independent, evidence-based findings and advice to the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA). The Scientific Report, alongside public comments and federal agency input, will inform the two departments as they develop the Dietary Guidelines for Americans, 2025-2030, which is expected to be published in late 2025.” * * *
  • “HHS and USDA will open a 60-day public comment period and encourage the public to provide written comments on the Committee’s Scientific Report. The departments will also hold a public meeting on January 16, 2025, to listen to oral comments from the public on the Scientific Report. Pre-registration is required for the public meeting. More information on the public meeting and comment period is available on DietaryGuidelines.gov.”
    
• The Wall Street Journal adds,
  • “The fight over what you should eat is escalating, with a new report out that moves the government closer to recommending Americans limit red meat, eat more beans, and cast a wary eye on ultra processed foods.
  • “Draft recommendations, by a committee of scientists advising the U.S. government on its next round of dietary guidelines, were first discussed in October. 
  • “Tuesday’s report comes at a time of growing debate about which foods are healthy—and who decides. For years, Americans largely accepted the guidelines, once dominated by the famous food pyramid. Now plenty of people are just as comfortable taking dietary advice from TikTok nutritionists and longevity podcasters as they are from mainstream doctors.
  • “Donald Trump’s election has further amped up the debate about what Americans should eat as more links are drawn between diet and chronic disease. Robert F. Kennedy Jr., the president-elect’s nominee to lead the Department of Health and Human Services, has criticized ultra processed foods and artificial dyes and other additives found in many foods. And there’s a battle brewing over the best source of protein, with red meat champions in one camp and plant-based supporters in another.
  • “Food is a hot-button issue,” said Christina A. Roberto, director of the Center for Food and Nutrition Policy at the University of Pennsylvania. “It’s wrapped up in tradition.” That’s part of what makes people resistant to being told they need to change how they eat, she notes.”

• The U.S. Preventive Services Task Force proposed new Grade A cervical cancer screening recommendations for women aged 21 to 65.
  • The USPSTF recommends screening for cervical cancer every 3 years with cervical cytology alone in women ages 21 to 29 years and then every 5 years with clinician- or patient-collected high-risk human papillomavirus (HPV) primary screening in women ages 30 to 65 years.
  • As an alternative to HPV primary screening for women ages 30 to 65 years, the USPSTF recommends continued screening every 3 years with cervical cytology alone or screening every 5 years with high-risk HPV testing in combination with cytology (cotesting).
• The second sub-bullet is a new recommendation. The comment period on the proposed recommendation ends on January 13, 2025.

• The New York Times adds,
  • “The [USPSTF] advice was issued amid growing concern about a falloff in cancer screenings, and confusion resulting from changes over time in screening regimens and tests used for early detection and prevention of cervical cancer.
  • “Use of self-collected vaginal swabs for HPV tests is being recommended for the first time in the guidelines, partly in an effort to increase screening and make it easier.
  • “It’s important to emphasize that cervical cancer is one of the most treatable and preventable types of cancer,” because screening is so effective, said Dr. John Wong, vice chair of the task force.
  • “Cervical cancer tends to be slow-growing, he explained. Pap smears can pick up precancerous changes, while HPV tests pick up persistent infections that don’t resolve on their own and may trigger cancerous cellular changes over time.”

• The Washington Post points out,
  • “The Environmental Protection Agency on Monday banned two known carcinogens used in a variety of consumer products and industrial settings that can seep into the environment through the soil and waterways.
  • “The new rules, which underscore President Joe Biden’s efforts to enact key protections against harmful chemicals before leaving office, include the complete ban of trichloroethylene — also known as TCE — a substance found in degreasing agents, furniture care and auto repair products. The agency also banned all consumer uses and many commercial uses of perc — also known as perchloroethylene and PCE — an industrial solvent long used in applications such as dry cleaning and auto repair.
  • “Both of these chemicals have caused too much harm for too long, despite the existence of safer alternatives,” said Jonathan Kalmuss-Katz, a senior attorney at Earthjustice.”

• The Wall Street Journal adds,
  • “Nigel Brockton, vice president of research at the American Institute for Cancer Research, says the general population’s exposure to these chemicals is likely very limited.
  • ​“It’s a good thing that [the EPA] are eliminating these carcinogens but unless you’ve had substantial exposure, either through occupation or through industrial contamination of your environment, we would still say focus on the factors that you can control,” says Brockton, who recommends activities like eating a healthy diet and limiting alcohol.”

From the judicial front,

• Reuters informs us,
  • “The U.S. Supreme Court on Monday declined to hear an appeal by the nation’s leading drug industry group challenging an Arkansas law requiring pharmaceutical companies to offer discounts on drugs dispensed by third-party pharmacies that contract with hospitals and clinics serving low-income populations.
  • “The court’s decision comes as the industry group, Pharmaceutical Research and Manufacturers of America, known as PhRMA, and individual drugmakers have filed a series of similar lawsuits in recent months over other state laws meant to ensure that hospitals can use contract pharmacies while participating in the federal 340B discount program.”

• STAT New lets us know,
  • “The Ohio Supreme Court ruled that three of the largest pharmacy chain operators in the U.S. could not be held liable under a state nuisance law for contributing to the long-running opioid crisis.
  • “In a 5-to-2 vote, the court determined that the law barred two Ohio counties from obtaining a $650.9 million judgment that was won in a federal court against CVS Health, Walgreens, and Walmart. In explaining the decision, the court maintained that a state product liability law, which had been amended in 2007, superseded the nuisance claims.”

• The Wall Street Journal relates,
  • “A federal judge blocked Kroger from acquiring Albertsons, siding with Biden administration antitrust enforcers who said the $20 billion supermarket merger would erode competition and raise prices for consumers.
  • U.S. District Judge Adrienne Nelson agreed with the Federal Trade Commission’s argument that Kroger would become the dominant player in traditional supermarkets if allowed to add nearly 2,000 stores by taking over Albertsons, its smaller rival. Nelson rejected the companies’ counterargument that selling 579 stores to C&S Wholesale Grocers would replace the lost competition.
  • “Evidence shows that defendants engage in substantial head-to-head competition and the proposed merger would remove that competition,” Nelson wrote in the ruling.” * * *
  • “Representatives for Kroger and Albertsons said the companies were disappointed by the decision and that they are weighing their options.”
     
• The New York Times reports,
  • “A suspect charged with murder in New York in the assassination of the chief executive of UnitedHealthcare in Midtown Manhattan will fight extradition to New York to face murder charges, potentially keeping him in custody in Pennsylvania for weeks.
  • “He is contesting it,” said his lawyer, Thomas Dickey.
  • “The suspect, Luigi Mangione, 26, was charged late Monday in Manhattan with second-degree murder, forgery and three gun charges.” 
• and
  • “Brian Thompson, the chief executive of UnitedHealthcare who was gunned down in a brazen killing in New York, was laid to rest this week at a private funeral service in his Minnesota hometown.
  • “On Monday, while the nation was transfixed by the arrest of a 26-year-old man from Maryland who was charged with the murder, family and friends of the slain executive gathered at a Lutheran church in Maple Grove, Minn., to mourn the loss of a husband and father who ascended from modest roots in Iowa to one of the most powerful roles in the health care industry.”
  • RIP

From the public health and medical research front,

• The American Hospital Association News lets us know,
  • “A study released Dec. 9 by FAIR Health shows an increase in cancer treatment rates for people aged 18-49. The study examined treatment rates for that age group between 2016 and 2023 and noted an overall decrease. From 2020-2023, however, patients aged 18-29 experienced the largest increase in treatment rates at 11.7%, followed by a 7.5% increase for patients aged 40-49 and a 7.2% increase for individuals aged 30-39.”

• The Washington Post notes,
  • “Federal disease trackers reported Tuesday that the first child diagnosed with bird flu in an ongoing U.S. outbreak was infected with a virus strain moving rapidly through dairy cattle, even though there is no evidence the youngster was exposed to livestock or any infected animals.
  • “The finding by the Centers for Disease Control and Prevention about the child, who lives in California, deepened the mystery about the spread of H5N1 bird flu, a viral ailment that epidemiologists have watched warily for more than two decades, fearing it could spark a pandemic.”

• KFF CEO Drew Altman discusses the twin problems of mental healthcare — access and affordability.

• Per Infectious Disease Advisor,
  • “Severe outcomes are uncommon among children with pneumonia regardless of whether antibiotics are received, according to study results published in JAMA Network Open.” * * *
  • “These results suggest that some children diagnosed with pneumonia can likely be managed without antibiotics and highlight the need for prospective studies to identify these children,” the researchers concluded.”

• Per a National Institutes of Health press release,
  • “The antiviral drug tecovirimat did not reduce the time to lesion resolution or have an effect on pain among adults with mild to moderate clade II mpox and a low risk of developing severe disease, according to an interim data analysis from the international clinical trial called the Study of Tecovirimat for Mpox (STOMP). There were no safety concerns associated with tecovirimat.
  • “Considering these definitive findings, the study’s Data Safety and Monitoring Board (DSMB) recommended stopping further enrollment of participants who were being randomized to tecovirimat or placebo. As the study sponsor, the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) accepted the DSMB’s recommendation. Given the lack of an efficacy signal, NIAID also closed enrollment into an open-label study arm for participants with or at elevated risk of severe disease that was not designed to estimate the drug’s efficacy.”

• STAT News informs us,
  • New data suggests researchers may have found one of their most promising candidates yet for the next generation in immunotherapy drugs — bispecific antibodies targeting two key proteins in cancer, PD1 or PD-L1 and VEGF.
  • A small early trial on one such bispecific compound was presented by researchers working with BioNTech at the San Antonio Breast Cancer Symposium on Tuesday. The bispecific compound, called BNT-327, had positive results in patients with triple negative breast cancer. If future trials on the bispecific produce more positive data, it could become a critical part of how triple negative breast cancer — and potentially other cancers — are treated.
  • The research builds on the 1990s discovery of immunotherapy drugs called checkpoint inhibitors, which was “transformative” in oncology, BioNTech co-founder and CMO Özlem Türeci told STAT. Drugs like Merck’s Keytruda can help stimulate the immune system to find and kill cancer cells and have become a mainstay in the standard treatment of many different cancer types. 
  • “But there’s still space for improvement. We all were looking for the next-generation checkpoint inhibitors,” Türeci said. “I believe PD-L1 or PD1 and anti-VEGF bispecifics are exactly this next-generation compound.”

• Per BioPharma Dive,
  • “An experimental drug from NewAmsterdam Pharma has shown it may protect heart health in a Phase 3 study, a finding Wall Street analysts believe boosts the medicine’s chances of improving the outcomes of people with cardiovascular disease in an ongoing, closely watched clinical trial. 
  • NewAmsterdam on Tuesday said the drug, obicetrapib, met its main goalin the third of three late-stage trials. People with either an inherited condition called heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease who received obicetrapib alongside other medicines saw their levels of LDL, or “bad,” cholesterol fall by an average of 33% after 84 days when adjusted for placebo. That result is similar to what was observed in the two previous Phase 3 trials and will form the basis of approval filings NewAmsterdam intends to discuss with U.S. regulators next year, according to the company.
  • “Obicetrapib’s safety profile, including its potential impact on blood pressure — a concern for drugs of its kind, known as CETP inhibitors — were also comparable to a placebo. A higher percentage of patients in the placebo arm dropped out of the trial due to treatment-related side effects, NewAmsterdam said. 
  • “Notably, though the study wasn’t set up to definitively prove whether obicetrapib could lower the risk of heart disease-related complications, testing revealed signs of a possible benefit.” 

• BioPharma Dive also brings us a report from the American Society of Hematology’s meeting in San Diego.

From the U.S. healthcare business front,

• The Wall Street Journal reports,
  • “Walgreens is in talks to sell itself to a private-equity firm in a deal that would take the pharmacy chain off the public market after its shares have been on a downward slide for nearly a decade. 
  • “Walgreens Boots Alliance and Sycamore Partners have been discussing a deal that could be completed early next year, assuming talks don’t fall apart, according to people familiar with the matter.
  • “Walgreens’s market value reached a peak of over $100 billion in 2015 but had since shrunk to around $7.5 billion as of Monday. Mounting pressures on both its pharmacy and retail businesses had helped send its shares down nearly 70% so far this year before The Wall Street Journal reported on the deal talks Tuesday.
  • “Walgreens’s shares closed up 18% Tuesday after the report—marking the highest one-day jump in the company’s history and giving it a market value of around $9 billion.”
• and
  • “Weight-loss drugs could be a boon for insurers, but it is too soon to tell whether the industry will be transformed, the head of Swiss Re’s life and health reinsurance arm said.
  • “The market for obesity drugs such as Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy is booming after studies found the treatments helped patients shed weight and showed promise for health problems ranging from heart-attack risk to alcohol abuse. Lower rates of obesity—which has long been a public health crisis in the U.S. and is linked to many chronic conditions—could lead to smaller health-related claims for insurers and better underwriting margins.
  • “While excitement about the drugs is high, Swiss Re Life & Health Chief Executive Paul Murray said in an interview that many questions remain unanswered.
  • “Often when you get new things, they look shiny and new and we learn over time that it’s best to kind of wait and see a bit what the impact is,” Murray said. Reinsurers like Swiss Re backstop insurance companies’ largest risks.
  • “The rising use of these therapies has the potential to accelerate improvements in life expectancy, which has implications for the life insurance market, Murray said. However, it remains to be seen how long the health benefits of the drugs last, whether people are willing to stay on them long term or can afford to do so, and what happens when they stop taking them, he added.
  • “As things stand today, I would bet pricing will improve, but of course we have to wait and see what the data tells us about the longer-term impact of these drugs,” Murray said.
  • “We don’t know if it’s unilaterally healthy for people to hold food in their stomach for longer,” the chief executive added. The main ingredient of these medications—which were originally developed for diabetes—mimics gut hormones, suppressing appetite and slowing digestion.”

• MedPage Today identifies the hospitals which offer the most outstanding maternity care.

• Per the American Hospital Association News,
  • “Baxter has resumed production on all of its 3-liter irrigation and peritoneal dialysis solutions manufacturing lines, the company announced Dec. 5. The company noted that despite production resuming for those lines, more time is needed to restore output to levels reached prior to Hurricane Helene. Baxter expects all manufacturing lines to resume operation by the end of the month.”