FEHBlog

Midweek Update

From Washington, DC,

  • Per a CMS press release issued today,
    • “Lowering the cost of prescription drugs for Americans is a top priority of President Trump and his Administration. In accordance with the statutory requirements of the Inflation Reduction Act, the Centers for Medicare and Medicaid Services (CMS) released the list of 15 drugs selected for the second cycle of the Medicare Drug Price Negotiation Program on January 17, 2025. As the second cycle begins under the Trump Administration, CMS is committed to incorporating lessons learned to date from the program and to considering opportunities to bring greater transparency in the Negotiation Program. CMS intends to provide opportunities for stakeholders to provide specific ideas to improve the Negotiation Program, consistent with the goals of achieving greater value for beneficiaries and taxpayers and continuing to foster innovation.”
  • The American Hospital Association (AHA) News tells us,
    • The AHA Jan. 28 voiced support for bipartisan legislation to reauthorize for five years the Dr. Lorna Breen Health Care Provider Protection Act, which provides grants to help health care organizations offer behavioral health services for front-line health care workers. Introduced yesterday by Sens. Tim Kaine, D-Va., Roger Marshall, R-Kan., Jack Reed, D-R.I., and Todd Young, R-Ind., the bill also would reauthorize a national campaign that provides hospital leaders with evidence-based solutions to support worker well-being. 
  • Federal News Network informs us,
    • “A significant majority of federal employees who took a Federal News Network survey say they don’t plan on accepting the Office of Personnel Management’s offer to resign and go on paid administrative leave.
    • “In a survey of 4,619 federal employees, more than three-quarters of respondents said they don’t intend to accept the deal OPM sent to most civil federal workers in a mass email Tuesday afternoon.” * * *
    • “More than 500 respondents — about 11% of those who took the poll — said they intend to accept the deal.
    • “Among those who expect to accept the offer, 54% said they already had plans to retire from federal service soon or leave for a job outside the federal workforce.” * * *
    • “About 70% of respondents said they don’t have enough information from OPM to make their decision either way. Many said OPM hasn’t provided enough details on what accepting the deal would mean for their health and life insurance plans, or whether it would impact their pensions.”
  • ICD10 Monitor relates,
    • “The Centers for Medicare & Medicaid Services (CMS) have issued the display copy of the Final Rule interpreting the 60-day Refund Rule for Medicare Parts A/B (Traditional Medicare) and C/D (Medicare Advantage, or MA, and the Prescription Drug Plans) established by the Patient Protection and Affordable Care Act.
    • “The Final Rule became effective as of Jan. 1, 2025. The 60-day Refund Rule is included as part of the 3,000+-page 2025 Physician Fee Schedule Final Rule. 
    • “The federal Overpayment Statute requires any person who receives or retains Medicare or Medicaid funds to which they are entitled to report and return any overpayment to the appropriate government official or contractor within 60 days after “identification” of the overpayment, per Section 1128J(d) of the Social Security Act, 42 U.S.C. § 1320a-7k(d).
    • “Failure to report and return an “identified” overpayment in a timely manner could create a false claim situation subject to the False Claims Act (FCA). The False Claims Act, among other things, addresses individuals who knowingly conceal or avoid an obligation to pay or refund money to the federal government.”

From the public health and medical research front,

  • STAT News reports,
    • In July 2022, 988 launched as the number anyone across the country could dial in a mental health crisis. It’s one entryway to a sprawling system of mental health care options, but new research shows that since then, critical crisis services have not become more available — a key objective of the nationwide rollout, designed to strengthen an underfunded, patchwork system that left many people alone in times of crisis. 
    • While calls to the national hotline have continued to increase, fewer psychiatric facilities are offering emergency psychiatric walk-in services, mobile crisis response units, and suicide prevention services, according to a study published Wednesday in JAMA Psychiatry.
    • “988 isn’t going to reach its full potential until there’s a full system of crisis services in every single community,” said Hannah Wesolowski, chief advocacy officer at the National Alliance on Mental Illness.”
  • and
    • From plant-based chocolate milk to fizzy reduced-sugar drinks courtesy of Michelle Obama, the beverage market is always introducing new offerings to appeal to kids. But new dietary recommendations from several major health organizations say that children should really stick with drinking water and plain pasteurized milk.
    • The recommendations for children ages 5-18, released Wednesday, come from the Academy of Nutrition and Dietetics, the American Academy of Pediatric Dentistry, the American Academy of Pediatrics, and the American Heart Association. 
    • Their advice is in keeping with broader draft dietary guidelines created by an advisory committee to the U.S. government at the end of last year, which also said water should be the main thing that people of all ages drink. But the report is notable in carving out specific stances on the wide range of beverage options marketed to families, including plant-based milk and drinks containing non-sugar sweeteners. 
  • Per MedPage Today,
    • Fluctuating cholesterol levels were tied to higher dementia risks in a large study of older adults.
    • Relationships were seen for variability in both total cholesterol and LDL-C levels.
    • Links with dementia were independent of baseline values or whether trends were up or down.
  • Per Healio,
    • The addition of high-dose IV vitamin C to standard chemotherapy nearly doubled overall survival for patients with advanced pancreatic cancer, according to results of a randomized phase 2 trial.
    • Vitamin C also delayed the impact of adverse events and improved quality of life.
  • Per Medscape,
    • “Low-dose aspirin reduced colorectal cancer (CRC) recurrence rates by more than half in patients with tumors harboring mutations in the PI3K signaling pathway, according to findings from the phase 3 ALASCCA trial.
    • “These results stress “the importance of upfront genomic testing” in patients with CRC, said Anna Martling, MD, PhD, from Karolinska Institutet, Stockholm, Sweden, who reported the findings at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium 2025 in San Francisco.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “A big-business coalition is using hospital, insurer and employer healthcare cost information to help companies negotiate the price of services and coverage for employees.
    • “The Purchaser Business Group on Health will combine healthcare price transparency data and other information from providers and insurers with claims data from five large employers to analyze the cost and quality of care across 10 markets, the group said in a Wednesday news release.
    • “We are developing a new level of transparency and analysis that does not currently exist for the commercial market,” PBGH Chief Operating Officer Won Andersen said in the news release. “The project represents a pivotal step toward enhancing transparency and accountability in healthcare spending and purchasing.”
  • Beckers Payer Issues lets us know,
    • “Express Scripts, The Cigna Group’s pharmaceutical benefit manager, will implement new policies designed to prevent members from paying the full list price for drugs. 
    • “Most Express Scripts patients spend less than $100 out-of-pocket for their prescriptions each year, but some patients in high-deductible plans may pay the full list price for medications, according to a Jan. 29 news release. 
    • “Evernorth, Cigna’s health services arm, which manages Express Scripts, will shift its standard offerings to protect patients from paying the list price for medications. The company will also implement better predictability in drug pricing for patients, especially those in high deductible plans, according to the release.” 
  • Per Fierce Healthcare,
    • “Amazon One Medical continues to build out its health system partnerships to expand its network of primary care clinics.
    • “Montefiore Health System is now partnering with the company to open up access to primary and specialty care in New York’s Westchester County and surrounding areas.
    • “Amazon, which bought primary care company One Medical in a $3.9 billion deal in 2023, will open its first primary care offices in Westchester County in affiliation with Montefiore next year, the companies announced Wednesday.
    • “The primary care office will offer same and next-day appointment availability, on-site lab services and wraparound virtual care support for members, Amazon said.
    • “This new relationship will enable patients to have increased access to seamless coordinated care through Amazon One Medical’s innovative care model and Montefiore’s high-quality network of specialists, hospitals, and facilities.
    • ‘Montefiore and Amazon One Medical will determine where to open new facilities over the next several years, executives said.”
  • The Wall Street Journal observes,
    • If obesity is a chronic disease, like kidney or heart conditions, demand for GLP-1 drugs shouldn’t ebb and flow with the seasons. But the weight-loss market is far from typical.
    • After analyzing data going back to 2016, one analyst thinks he has identified a seasonal pattern in demand for drugs such as Eli Lilly’s LLY Zepbound and Novo Nordisk’s NOVO.B Wegovy: The drugs have stellar growth in initial sign-ups in the first half of the year followed by slower gains in the second half. 
    • This pattern resembles the cyclical nature of gym memberships rather than the steady trajectory of most pharmaceutical markets, and for good reason: At the start of the year, people often make resolutions to lose weight, exercise or start new diets. It stands to reason that some of these resolutions might also lead to increased demand for weight-loss prescriptions such as GLP-1 drugs.
    • If the logic is even half-right, it could help explain Eli Lilly’s back-to-back misses [in the second half of 2024] that have confounded Wall Street.
  • MedTech Dive offers “four robotic surgery trends to watch in 2025. Intuitive Surgical will face competition this year from Medtronic and smaller companies like CMR Surgical and Moon Surgical coming to the U.S. market with robotic surgery systems.”

Tuesday Report

OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC

  • The Washington Post reports,
    • “The White House’s Office of Personnel Management sent an email blast Tuesday to civilian government employees offering them an easy way to quit with pay through Sept. 30, the most sweeping effort yet by the new Trump administration to shrink the ranks of the federal workforce.
    • “The email instructed employees to reply to the message saying they want to resign if they would like to take the offer, which would provide the incentive for workers who accept by Feb. 6, said an Office of Personnel Management spokesperson. Not all employees will be eligible, according to the spokesperson, who said some of the exemptions will be up to agency heads. Additional carveouts exist for immigration officers, some people in national security-focused roles, the Postal Service and the armed forces, the spokesperson said.”
  • Here is a link to OPM’s FAQs on its “Fork in the Road” program.
  • Federal News Network adds,
    • “Federal employees have filed a lawsuit against the Trump administration’s Office of Personnel Management, after the agency created and began testing an email system meant to deliver mass communications directly to federal employees’ inboxes.
    • “The lawsuit from two anonymous federal employees in the executive branch alleges OPM violated the 2002 E-Government Act by not releasing details of how the communication system will manage federal employees’ personal information stored in the system.
    • “Kel McClanahan, executive director of the National Security Counselors law firm, filed the pro bono lawsuit on behalf of the plaintiffs, alleging that the email system poses security risks for federal employees’ personal information.”
  • and
    • “President Donald Trump’s pick to oversee much of the federal government’s real estate portfolio is looking to significantly downsize the amount of office space that agencies occupy.
    • “Michael Peters, commissioner of Public Buildings Service within the General Services Administration, said the agency is looking at cutting up to half its total real estate portfolio over the coming years.
    • “I’m just getting ramped up, but I think our initial review says that number could be up to a 50% reduction on our square footage across the portfolio. We’re not going to do that in six months, but we’re going to try to do this as rapidly as we can,” Peters said Tuesday.
    • “Peters said a “disproportionate amount of that space” would come from the Washington, D.C. metro area — and will include GSA moving out of its own 1800 F Street headquarters.”
  • The President issued an executive order today announcing, “the policy of the United States that it will not fund, sponsor, promote, assist, or support the so-called “transition” of a child [including teenagers under age 19] from one sex to another, and it will rigorously enforce all laws that prohibit or limit these destructive and life-altering procedures.”
    • With respect to the FEHB Program
      • “The Director of the Office of Personnel Management, as appropriate and consistent with applicable law, shall:
        • “(a)  include provisions in the Federal Employee Health Benefits (FEHB) and Postal Service Health Benefits (PSHB) programs call letter for the 2026 Plan Year specifying that eligible carriers will exclude coverage for pediatric transgender surgeries or hormone treatments; and
        • “(b)  negotiate to obtain appropriate corresponding reductions in FEHB and PSHB p
          premiums.”
  • STAT News informs us,
    • “The Center for Medicare and Medicaid Innovation is continuing plans to implement a pilot project testing new ways for state Medicaid programs to pay for multimillion-dollar cell and gene therapies.
    • “The pilot was started during the Biden administration, following an executive order from former President Biden that directed the center to come up with new ideas to lower drug prices. President Trump rescinded that executive order on Inauguration Day, which initially left the future of the pilot unclear. 
    • “President Trump’s Executive Order never rescinded the work that was underway by the CMS Innovation Center on drug models,” a Department of Health and Human Services spokesperson said in an email to STAT.
    • “The pilot addresses an existential issue for state Medicaid programs: how to pay for cell and gene therapies that are highly effective, but expensive, on fixed budgets. 
    • “Two drug manufacturers that make treatments for sickle cell disease are participating: Bluebird Bio, which makes Lyfgenia, and Vertex Pharmaceuticals, which makes Casgevy. Lyfgenia’s list price is $3.1 million, and Casgevy’s list price is $2.2 million.” 
  • The Wall Street Journal lets us know,
    • Novo Nordisk said the Food and Drug Administration approved the diabetes-drug Ozempic to be used to help kidney-disease patients.
    • “Ozempic, or semaglutide, can now be used to reduce the risk of worsening kidney disease or kidney failure in adults with type 2 diabetes and chronic kidney disease, the company said Tuesday.
    • “The approval makes Ozempic the most broadly indicated GLP-1 drug on the market, the Bagsvaerd, Denmark, company said. The FDA approved semaglutide for weight loss under the brand name Wegovy in 2021.”
  • BioPharma Dive adds,
    • “The Food and Drug Administration on Monday expanded use of AstraZeneca and Daiichi Sankyo’s Enhertu, allowing the drug to be given earlier and more broadly in people with an aggressive form of breast cancer.
    • Since 2022, Enhertu has been approved in the U.S. to treat advanced breast tumors expressing “low,” but still detectable, levels of the HER2 protein. With its new decision, the agency widened Enhertu’s availability to include treatment of tumors with “ultralow” HER2 expression. HER2 protein levels must be determined by an FDA-approved test, AstraZeneca and Daiichi said in a statement.”

From the public health and medical research front,

  • The Washington Post reports,
    • “A new strain of avian influenza has been identified for the first time in the United States, raising concerns that the virus is transforming in a way that could eventually cause wider outbreaks among humans.
    • “U.S. officials disclosed the discovery of the virulent H5N9 strain at a California duck farm in a report in recent days to the World Organization for Animal Health, which maintains a database of animal disease threats.
    • “That disclosure comes as the United States confronts a growing outbreak of another bird flu strain, H5N1, that is spreading in poultry farms across the nation and has infected dairy cows for the first time. Human cases have been sporadic and confined mostly to dairy workers exposed to sick animals.
    • “The H5N9 strain itself does not pose a grave threat to humans, officials and experts said.”
  • The American Hospital Association News tells us,
    • “Dementia cases in the U.S. are expected to double by 2060, reaching 1 million new cases per year, according to a study released Jan. 13 by NYU Langone Health. The study found that the risk of developing dementia any time after age 55 is 42%, more than double the risk reported in prior studies. The study authors attributed previous underestimates of dementia risk to unreliable documentation in health records and on death certificates, minimal surveillance of early-stage dementia cases and underreporting of cases by race.” 
  • The New York Times relates,
    • “Rates of sudden unexpected infant death in the United States increased by nearly 12 percent from 2020 to 2022, according to new research published on Monday in the journal JAMA Pediatrics.
    • “Though the study offered some good news — overall infant mortality rates dropped by 24 percent from 1999 to 2022 — it also raised questions about why more babies appear to be dying during sleep, and why rates of sleep-related death remain notably higher among Black, Native American and Pacific Islander babies than among white and Asian infants.
    • “Dr. Elizabeth Wolf, an associate professor of pediatrics with Children’s Hospital of Richmond at Virginia Commonwealth University who was among the new study’s authors, called the findings “pretty alarming.”
    • “The death of an infant from SIDS or SUID is unbelievably horrific,” Dr. Wolf continued, using two acronyms that describe sleep-related deaths among infants. “And we as a public health community need to do everything we can to try and reduce the risk factors as much as possible.”
  • Cardiovascular Business relates,
    • “Cannabis use is on the rise throughout the United States, but it is not as harmless as some people may believe. In fact, according to a new in-depth analysis in Nature Reviews Cardiology, regular cannabis use increases a person’s risk of multiple adverse cardiovascular outcomes, including myocardial infarction, arrhythmias and cardiomyopathy.[1]
    • “The study’s authors, a group of researchers with the Stanford Cardiovascular Institute, explored a wide variety of topics, including ongoing policy trends related to cannabis and the science behind why it appears to make such a significant impact on the cardiovascular system. The group also emphasized that it will be important to learn more about the long-term impact of cannabis use as time goes on. 
    • “Cannabis is emerging as a risk factor for adverse cardiovascular health,” wrote first author Mark Chandy, MD, PhD, who is now an assistant professor at Western University in Ontario, Canada, and colleagues. “With changing public perceptions and an overall decline in tobacco use, cannabis is poised to replace tobacco as a legal drug of choice. Previous restrictions are ending with the widespread decriminalization and legalization of cannabis, boosting use of the drug. A public perception that cannabis is harmless and therapeutically beneficial persists, despite mounting evidence from preclinical and clinical studies showing that cannabis use can harm the cardiovascular system and pose other serious health problems, not unlike tobacco.”
  • Per Beckers Hospital Review,
    • “Cedars-Sinai experts are advocating for patients to have access to GLP-1 medications such as semaglutide as a key component to caring for and preventing cardiovascular disease. 
    • “Physicians are now able to improve multiple “downstream” conditions, such as heart disease, by prescribing one medication “upstream,” according to a Jan. 10 news release from Los Angeles-based Cedars Sinai. 
    • “Amanda Velazquez, MD, director of obesity medicine at the health system, said in the release that semaglutide has enabled patients with high blood pressure to reduce their antihypertensive medications.
    • “Martha Gulati, MD, director of preventive cardiology and the Anita Dann Friedman Chair in Women’s Cardiovascular Medicine and Research at Cedars-Sinai, said although semaglutide has been associated with blood pressure and cholesterol level improvements, it does not replace statins. 
    • ‘Dr. Gulati also said the effectiveness of the drug class raises the important question: “Do we want patients to get CVD and only then treat them? Or should we treat them earlier so we can prevent CVD events?”
  • The Wall Street Journal discusses “The Scientific Fight Over Whether Aging Is a Disease.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Drugmakers raised the list prices of more than 800 prescription drugs for blood pressure, cancer and other conditions by a median 4% at the start of this year.
    • “The modest size of the annual increases could help companies avoid criticism of gouging from President Trump while seeking his administration’s support for such priorities as taking aim at the rebates given to middlemen and altering a federal program providing discounts to certain hospitals. Last year’s median price increase was 4.5%.”
  • Fierce Healthcare points out,
    • “The National Community Pharmacists Association (NPCA) is warning the feds that independent pharmacists are likely to face significant financial hardship due to Medicare drug price negotiations.
    • “In comments submitted on the latest Medicare advance notice, the organization says it conducted a survey of 8,000 pharmacy owners and managers about the drug price negotiation program and found that 93.2% have either decided not to stock drugs under negotiation or are considering not stocking these products.
    • “The survey found that 32.8% of independent pharmacists have already made the decision to not stock one or more of the 10 drugs in the first round of negotiations. In addition, 60.4% of those surveyed said they are considering similar steps.
    • “The NCPA said this is because they’re concerned about “financial losses” through the program.
    • “That will be devastating to the program,” said NCPA CEO B. Douglas Hoey in a press release. “Patients who need these prescriptions will be unable to get them, because their pharmacies cannot participate in the program.'”
  • Per Beckers Hospital Review,
    • “In less than a year, Mark Cuban’s Cost Plus Marketplace has expanded its portfolio to more than 6,000 medicines. 
    • ‘Mark Cuban Cost Plus Drug Co. launched the Marketplace in February 2024, which at the time had more than 4,000 medicines in short supply to directly sell to healthcare facilities. 
    • ‘Since then, customers have realized savings between 40% and 60% compared to traditional wholesalers, according to Chief Commercial Officer Alan Bowe. 
    • “The Marketplace now sells to thousands of hospitals, clinics, ambulatory surgery centers, long-term care sites, dialysis centers and retail pharmacies in all 50 states, Mr. Bowe told Becker’s Jan. 23.”
  • Beckers also brings us up to date on current drug shortages.
  • Fierce Healthcare lets us know,
    • CVS Health is rolling out a new customer app that aims to make it simpler and more convenient for users to manage health benefits, pharmacy benefits and prescriptions.
    • Within the application, users can monitor prescriptions for themselves as well as family members across CVS’ pharmacies, Caremark mail orders and CVS Specialty. This includes “full transparency” into the status of a prescription order and the cost, CVS said.
    • In addition, users can schedule key immunizations for their entire family, and access spending and benefits details from both Aetna and Caremark through the app.
  • Beckers explains the new normal in hospital capacity and announces
    • “UNC Health and Duke University Health System, based in Chapel Hill, N.C., and Durham, N.C., respectively, are uniting to build a comprehensive healthcare campus, featuring the state’s first freestanding children’s hospital.
    • “The two institutions filed legal documents Jan. 28 with the state to establish a nonprofit entity, North Carolina Children’s, according to a joint news release. 
    • NC Children’s will feature a 500-bed children’s hospital on a 100-plus-acre campus at a yet-to-be-identified site in the Research Triangle region.
    • “The new campus will also include a children’s behavioral health center, outpatient clinics, research and teaching facilities, hospitality houses (e.g., Ronald McDonald House) and mixed-use infrastructure to accommodate hotels, restaurants and retail stores, according to the release.”

Monday Report

Photo by Sven Read on Unsplash

From Washington, DC,

  • Nextgov/FCW reports,
    • “Billionaire Elon Musk paid a visit to the Office of Personnel Management’s building on Friday, people familiar have confirmed to Nextgov/FCW.” * * *
    • “Amanda Scales, a former employee of Musk’s artificial intelligence company xAI, is OPM’s new chief of staff.” 
  • Fedscoop informs us,
    • “The Trump administration is giving agency leaders two weeks to submit plans for how they intend to comply with the presidential directive to return all eligible employees to full-time, in-person work, the latest salvo in the restructuring of the federal workforce.  
    • “In a memo sent to agency heads Monday, the acting directors of the Office of Personnel Management and the Office of Management and Budget set a Feb. 7 deadline for return-to-work implementation plans, which will be reviewed and approved by OPM and OMB.”
  • The Senate confirmed Scott Bessent to be Secretary of the Treasury today by a 68-29 vote. The Secretary of the Treasury along with the Secretary of Health and Human Services and the Secretary of Labor, are Affordable Care Act regulators.
  • Roll Call adds,
    • “Bessent, 62, will become the nation’s first openly gay Treasury secretary and the highest-ranking LGBTQ government official in the country’s history.” * * *
    • “He brings a wealth of private-sector experience in the economy and markets to his new role, as well as a concern for the needs of working Americans,” Senate Majority Leader John Thune, R-S.D., said on the floor Monday before the vote.
    • “Senate Finance Chairman Michael D. Crapo, R-Idaho, during the confirmation process similarly praised Bessent’s character, demeanor and experience, while defending him from Democratic attacks about the nominee’s handling of his taxes.”
  • Roll Call also tells us,
    • “The Senate keeps processing President Donald Trump’s nominees this week, but much of the congressional attention will be on South Florida, where House Republicans are gathering for their annual issues and strategy conference.
    • “The conference is taking place at Trump National Doral in Miami, the president’s own private golf club, and Trump is expected to address the assembled lawmakers Monday evening.
    • “Punchbowl News reported over the weekend that Vice President JD Vance is expected to join the retreat as a headliner on Tuesday.
    • “Much of the discussion will focus on trying to plot the way forward for a filibuster-proof budget reconciliation package — especially to try to implement Trump’s immigration and tax policy agenda.”
  • The acting HHS Secretary Dorothy Fink announced,
    • “For nearly 50 years, the Hyde Amendment has protected taxpayer funds administered by the Department from paying for elective abortion. Pursuant to the President’s Executive Order of Jan. 24 (Enforcing the Hyde Amendment) and guidance from Office of Management and Budget, the Department will reevaluate all programs, regulations, and guidance to ensure Federal taxpayer dollars are not being used to pay for or promote elective abortion, consistent with the Hyde Amendment. This review will be conducted consistent with guidance issued by the Office of Management and Budget.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration has approved monthly maintenance dosing of Eisai and Biogen’s Alzheimer’s disease drug Leqembi.
    • “After taking Leqembi every two weeks for 18 months, patients can now transition to a monthly dose that the companies say is supported by modeling of data from Phase 2 and Phase 3 testing. Leqembi works by removing toxic aggregates of a protein from the brain.”

From the public health and medical research front,

  • STAT News reports
    • “In 2022, about 40% of deaths in the U.S. were caused by cardiovascular heart disease, including heart disease and stroke, which kill more people in the U.S. than the next two biggest killers — all forms of cancer and accidental deaths — combined. That’s according to an annual update from the American Heart Association on heart disease and stroke statistics, published today in Circulation
    • “Cardiovascular disease is “common, catastrophic, and costly,” an accompanying editorial notes. Despite its dominance, the overall number of deaths is leveling out after the pandemic shot numbers upwards. Yet contributing risk factors like high blood pressure and obesity continue to rise. 
    • Here are some more interesting findings:
      • The percentage of high schoolers who are physically active for over an hour every day decreased from almost 29% to just under 24% between 2011 to 2021.
      • Nearly 47% of all Americans have high blood pressure. In 2022, the prevalence was worst in Mississippi at about 40% and best in Colorado, at just under 25%. 
      • The rate of gestational diabetes in the U.S. increased 38% from 2016 to 2021, to 8.3% of pregnancies.
  • and
    • “Almost a century after people living in certain neighborhoods around Seattle and Tacoma, Washington were systemically denied financial services — a discriminatory, racist practice known as redlining — young cancer patients in those areas are dying at higher rates than those who live in unaffected areas. 
    • “An association between historic redlining and survival of adult-onset cancers has already been shown, but the data on adolescent and young-adult cancers come from a study published today in CANCER. Researchers analyzed data from 2000 to 2019 in those Washington cities on more than 4,300 patients aged 40 or younger, along with homeowners’ loan data and recent census tracts. They found that five years and 10 years after diagnosis, fewer people in previously redlined neighborhoods were still alive than those unaffected. (That’s about 85% vs. 90% five years out and 81% vs. 88% after ten years.)
    • “The disparity in deaths remained even after adjusting for factors like poverty. It emphasizes the importance of contextualizing today’s health disparities, the authors write, as well as the impact discrimination can have generations down the line.”
  • The New York Times suggests “‘A Dangerous Virus’: Bird Flu Enters a New Phase. A pandemic is not inevitable, scientists say. But the outbreak has passed worrisome milestones in recent weeks, including cattle that may have been reinfected.”
  • KAKE News from Wichita, Kansas, reports,
    • “State public health officials are calling an ongoing tuberculosis outbreak in northeast Kansas “unprecedented.” 
    • “The Kansas Department of Health and Environment [KDHE] reports 66 active cases of tuberculosis and 79 infections in the Kansas City Metro area in 2024. As of this month, the number of active cases rose to 67.
    • “In a Senate Committee on Public Health and Welfare meeting on Tuesday, Deputy Secretary of KDHE Ashley Goss said the department is working collaboratively with the Centers for Disease Control and Prevention.
    • “Some of you are aware we have mobilized staff and resources addressing an unprecedented tuberculosis outbreak in one of our counties,” Goss said. “We are working collaboratively with the CDC on that. The CDC remains on the ground with us to support.” * * *
    • “According to the KDHE website, there are currently 60 active cases of TB in Wyandotte County and seven in Johnson County. 
    • “Despite this, the KDHE says the cases are “very low risk” to the general public, including surrounding counties. 
    • “We are trending in the right direction right now, more to come on that,” Goss said in the meeting. “Hopefully we can get it wound down quickly.” 
  • The American Medical Association lets us know what doctors wish their patients knew about contagious norovirus.
  • Per Healio
    • “The vast majority of people in a study with long COVID had experienced multiple SARS-CoV-2 infections over the course of a 4-year period, researchers reported.
    • “While it is possible that the causes of long COVID could be many and variable depending on the patient population studied, with this cohort the evidence is clear that by having COVID numerous times, patients became more at-risk for developing long COVID,” Sean Clouston, PhD, professor in Stony Brook University’s Renaissance School of Medicine, said in a press release.”
  • and
    • “An investigational blood-based test identified nearly 80% of individuals who had colorectal cancer, according to results of a large prospective trial presented at ASCO Gastrointestinal Cancers Symposium. 
    • “The test also had a specificity greater than 90% for advanced colorectal neoplasia (ACN) and negative-predictive value for ACN.
    • “This new blood test may provide a convenient, effective option for colorectal cancer screening in the intended-use population, and perhaps help us boost adherence to screening,” Aasma Shaukat, MD, MPH, director of outcomes research and Robert M. and Mary H. Glickman professor of medicine at NYU Grossman School of Medicine, said during a press briefing.
  • Per BioPharma Dive,
    • “Treatment with an experimental drug from Akero Therapeutics substantially reversed liver damage in a mid-stage study of people with cirrhosis due to metabolic dysfunction-associated steatohepatitis, a common disease that was formerly known as NASH.
    • Announced Monday by Akero, the study results exceeded investor expectations, more than doubling the value of shares in the biotechnology company. They also helped to push up the stock of 89bio, a competitor developing a similar type of drug to Akero’s.
    • “While the Food and Drug Administration last year approved the first treatment for MASH, its use is limited to people whose livers aren’t yet cirrhotic. According to Akero, its drug is the first compound to show a significant reversal of cirrhosis due to MASH in clinical testing.”
  • The Wall Street Journal reports,
    • “Late-stage trial data for Roche’s drug against muscle-wasting Elevidys showed positive results after two years of treatment for male patients aged 4 or older with Duchenne muscular dystrophy.
    • “The data read-out reduced difficulties in standing, walking and running that were statistically significant, which increased between one year and two years after treatment, the company said. The safety profile was in line with the drug’s profile and no new safety signals were identified, it said.
    • “The treatment is on market for people living with Duchenne aged four years old and over regardless of their ambulatory status in the U.S., United Arab Emirates, Qatar, Kuwait, Bahrain and Oman. It is approved for the treatment of ambulatory individuals aged four through seven years in Brazil and Israel.
    • “Duchenne muscular dystrophy is a genetic disorder characterized by the progressive loss of muscle.”
  • STAT News relates,
    • “Right now, patients with obesity and cirrhosis have few treatments for their progressive liver disease, but a new study offers one available option: bariatric surgery. Weight loss operations significantly cut the long-term risk of developing serious liver complications when compared to standard nonsurgical therapy.
    • “The 62 patients with obesity and cirrhosis in the clinical trial who underwent bariatric surgery — either gastric bypass or gastric sleeve procedures — later had a 72% lower risk of developing more serious liver disease compared to the 106 patients who didn’t have surgery. After 15 years, 20.9% in the surgical group but 46.4% in the nonsurgical group developed one of the major complications of liver disease, including liver cancer and death. 
    • “We showed, regardless of the stage of disease, if we help people to lose weight, we can improve their outcomes. That can provide hope for patients and medical providers,” said Ali Aminian, director of the Bariatric and Metabolic Institute at the Cleveland Clinic and co-author of the study published Monday in Nature Medicine.  “We can change the trajectory of the disease.”
  • Per Beckers Hospital Review,
    • “An Alabama woman who received a gene-edited pig kidney transplant at NYU Langone in November is recovering well more than 60 days after the procedure. 
    • “On Nov. 25, a team of clinicians at the New York City-based health system successfully transplanted UKidney, a 10-gene-edited pig kidney into Towana Looney, 53. Ms. Looney was on a transplant waiting list for nearly eight years before physicians determined the probability of a safe human transplant was slim. 
    • “Now, Ms. Looney is the longest-living recipient of the four Americans who have received a gene-edited pig organ, having surpassed the two-month mark. 
    • “If you saw her on the street, you would have no idea that she’s the only person in the world walking around with a pig organ inside them that’s functioning,” Robert Montgomery, MD, PhD, director of NYU Langone’s Transplant Institute, told the Associated Press in a Jan. 25 report at NBC News. 
    • “Unlike previous xenotransplant patients, Ms. Looney was in better overall health at the time of her transplant, leaving experts optimistic about the potential for broader success in the emerging field of xenotransplantation. Earlier cases involved individuals who were critically ill when they underwent the experimental procedures.”

From the U.S. healthcare business front,

  • Beckers Hospital CFO Report tells us,
    • “Cleveland Clinic served the largest number of patients in its history in 2024 with more than 15 million patient encounters worldwide, generating nearly $16 billion in revenue and ending the year with a 1.7% operating margin.  
    • “The year-end findings come from the annual State of the Clinic address made by CEO and President Tom Mihaljevic, M.D., on Jan. 27. 
    • “Years have passed since the COVID-19 pandemic and healthcare has not recovered. Today, about 40% of U.S. hospitals continue to lose money,” Dr. Mihaljevic said. “In the past, we could predict Cleveland Clinic’s financial health based on our productivity and expense management, but even that has changed.”
    • ‘Dr. Mihaljevic noted that despite the handling of more than 15 million patient encounters, the health system’s 1.7% operating margin fell short of its anticipated 2.7%. He attributed this shortfall to new financial pressures, including unexpected increase in charity care totaling $370 million, surging cost of malpractice insurance and rising costs of drugs due to smaller discounts on medications.”
  • Per Healthcare Dive,
    • “HCA Healthcare reported fourth quarter earnings on Friday that narrowly beat analysts’ expectations following back-to-back hurricanes this fall.
    • “The Nashville-based provider posted $18.3 billion in revenue for quarter, up 6% year over year. However, profit dipped compared to the same period last year, falling from $1.6 billion to $1.4 billion.
    • “Still, several analysts noted HCA’s financial guidance for 2025 is slightly more conservative than expected, raising concerns that Trump administration funding cuts to Medicaid and the Affordable Care Act could impact hospitals’ bottom lines.”
  • Modern Healthcare reports,
    • “Shares of Walgreens Boots Alliance tumbled today following a CNBC report that the Deerfield-based pharmacy chain was unlikely to sell itself to a private-equity firm.
    • “CNBC’s David Faber said on air this morning that sources say the possible deal in which Walgreens would sell itself to New York-based Sycamore Partners is “mostly dead.”
  • Fierce Pharma identifies the ten most anticipated drug launches of 2025.
  • McKinsey & Co. point out “Most top pharma companies derive more than 60 percent of their revenue from therapies for diseases that affect women uniquely, differently, or disproportionately, putting them in a prime position to close the sex- and gender-based health gap.”

Weekend Update

From Washington, DC

  • The President’s nominee for Secretary of Health and Human Services, Robert F. Kennedy, Jr., will attend a Senate Finance Committee confirmation hearing on Wednesday and Senate Health, Education, Labor and Pensions Committee confirmation hearing on Thursday.
  • The Wall Street Journal reports,
    • “The Central Intelligence Agency has now concluded that the deadly Covid-19 pandemic most likely arose from a laboratory leak, lending credibility to a view that has been the focus of sharp debate among scientists and politicians for years.
    • “In doing so, the CIA has now joined the Federal Bureau of Investigation and the Energy Department in identifying a laboratory mishap in Wuhan, China, as the probable source of the Covid virus. It has killed more than 1.2 million Americans and over seven million people worldwide. 
    • CIA assesses with low confidence that a research-related origin of the COVID-19 pandemic is more likely than a natural origin based on the available body of reporting,” an agency spokesman said in a statement released Saturday. 
    • “The spokesman added that the judgment was “low confidence” and that the CIA would continue to evaluate “any available credible new intelligence reporting or open-source information that could change CIA’s assessment.” 
    • “The agency had previously taken the stance that it didn’t have enough information to assess whether the virus had leapt from an animal to a human or arose from a laboratory mishap. 

From the public health and medical research front,

  • The Washington Post notes
    • “Ever since the novel coronavirus reached the United States five years ago, it has unleashed punishing winter waves of illness.
    • “But the usual covid uptick is much more muted this winter and appears to have peaked. The virus is less rampant in wastewater compared with winters past. Hospitalization rates have gone down.
    • “Instead, an unusual medley of ailments emerged this season — walking pneumonia, RSV, norovirus and bird flu — along with the more familiar foe: influenza, which is garnering more attention than covid this time around because the hospitalization rate is three times as high.”
  • The University of Minnesota’s CIDRAP points out,
    • “The estimated effectiveness of the respiratory syncytial virus (RSV) among older US veterans in the 2023-2024 respiratory virus season against infection, emergency department/urgent care (ED/UC) visits, and hospitalization was 78%, 79%, and 80%, respectively.
    • “The findings, published this week in The Lancet Infectious Diseases, come from a target trial emulation study led by researchers at the Veterans Affairs Portland Health Care System in Oregon. The observational study was designed to fill in knowledge gaps remaining after clinical trials (e.g., vaccine effectiveness (VE) in people with weakened immune systems, effects on healthcare use for infection).”
  • and
    • “In the largest trial of its kind, patients receiving oral versus intravenous (IV) antibiotics for fracture-related infections (FRIs) had similar reoperation and reinfection rates, US researchers reported this week in JAMA Surgery. 
    • “But the primary and secondary analyses of trial results came to different conclusions regarding noninferiority, leaving some uncertainty about the findings.”
  • Per Fierce Pharma,
    • “Old drugs from Bristol Myers Squibb and Pfizer have delivered what the companies and researchers believe could establish them as new standard treatments for certain colorectal cancer patients.
    • “In Bristol Myers’ case, the company’s dual immunotherapy of Opdivo and Yervoy showed it could work better than Opdivo alone in patients with certain metastatic colorectal cancer. The combo lowered the risk of disease progression or death by 38% in patients with microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) tumors, according to data from the phase 3 CheckMate-8HW trial to be presented at the ASCO Gastrointestinal Cancers Symposium.
    • “The study randomized 707 patients across various lines of treatment, with 55% of participants in the Opdivo-Yervoy arm and 52% of the Opdivo monotherapy arm entering in the first-line setting.”
  • The Wall Street Journal discusses new approaches to treating minor injuries like sprains. “Updated methods for treating sprains, strains and bruises now focus on boosting your body’s natural healing process.”

From the U.S. healthcare business front,

  • Beckers Hospital Review shares 109 statistics on hospital margins, revenues, which are bumpy by region.”
  • Kauffman Hall offers an infographic on hospital and health system M&A trends in 2024.
  • Per HR Dive,
    • CFOs expect their companies to see a 7.3% rise in salaries and wages paid in the next 12 months, according to a Q4 Deloitte survey, which polled 200 finance chiefs at companies with a minimum of $1 billion in revenue shortly after the U.S. election in November. The pay projection was nearly double the 3.65% rise anticipated in Q3, according to the findings of the Big Four firm’s previous quarter’s report. 

Cybersecurity Saturday

From the cybersecurity personnel front

  • Saturday morning, two term South Dakota Governor Kristi Noem received Senate confirmation of the President’s nomination of her to be Secretary of Homeland Security, which is the home of the Cybersecurity and Infrastructure Security Administration (CISA). The Senate vote was 59-34 in her favor.
  • Federal News Network reports in a January 24, article,
    • Greg Barbaccia seems to be the new federal chief information officer. Barbaccia updated his LinkedIn page just recently.
    • He replaces Clare Martorana, who was the federal CIO for the last three-plus years.
    • Emails to OMB and the White House seeking confirmation and comment was not immediately returned.
    • Barbaccia is a former Army intelligence sergeant and intelligence community analyst from 2003 to 2009. Since then, he’s worked in the private sector.
  • FedScoop lets us know in a January 22, 2025, article,
    • The Office of Personnel Management again has a new chief information officer. 
    • Greg Hogan will serve as CIO, an agency spokesperson confirmed to FedScoop on Wednesday [January 22]. His appointment comes roughly a week after Melvin Brown II took over that role following former CIO Guy Cavallo’s retirement from federal service. 

From the cybersecurity vulnerabilities and breaches front,

  • On January 16, 2025, HHS’s Health Sector Cybersecurity Coordination Center issued its report on December 2024 vulnerabilities of concern to the health sector.
  • MedCity News points out that “Cybersecurity Threats Continue to Rise for Healthcare Organizations, Research Shows. The vast majority of healthcare organizations have spotted a cyberattack and suffered financial consequences as a result in the past 12 months, according to new research. A separate report also found that overall cyberattacks on healthcare organizations have risen by 32% year-over-year.”
  • Cybersecurity Dive tells us,
    • “Conduent, a New Jersey-based government contractor that provides technology platforms to multiple social service agencies and transit systems across the U.S., confirmed Wednesday it was impacted by a cyberattack.
    • “The incident first became public after Wisconsin officials reported delays in child support payments. Wisconsin was one of four states impacted by the outage.
    • “A spokesperson for Conduent confirmed the disruption was due to a cyber incident, but did not elaborate on the details. Conduent did not provide any details about how the incident was initially discovered or a specific timeline about the response.”
  • and
    • “BeyondTrust determined 17 customers were impacted in a December attack spree related to the compromise of a Remote Support SaaS API key. 
    • “The attack, attributed to a state-linked threat actor, included the compromise of several offices of the U.S. Treasury Department, where hackers gained access to unclassified data. 
    • “BeyondTrust said it worked with its affected customers to support their respective investigations by providing them with artifacts, logs, indicators of compromise and other information.
  • and
    • “Hewlett Packard Enterprise said it is investigating claims a threat group gained access to a trove of sensitive company data. 
    • “The threat group, IntelBroker, posted a claim on BreachForums that it had access to a large trove of HPE data, according to researchers from Arctic Wolf. 
    • “The allegedly stolen data includes private GitHub repositories, Docker builds, source code and other information, according to the posting. 
    • “Upon learning of the claim Thursday [January 23], the company immediately activated cyber response protocols, disabled related credentials and launched an investigation to determine whether the claims were valid, a spokesperson said Tuesday via email. 
    • “There is no operational impact to our business at this time, nor evidence that customer information is involved,” the spokesperson said.”
  • The American Hospital Association informs us
    • “The Cybersecurity and Infrastructure Security Agency and FBI Jan. 22 released an advisory explaining how cyberthreat actors “chained” vulnerabilities — deploying multiple vulnerabilities in rapid succession — during attacks on certain versions of Ivanti Cloud Service Appliances in September. Threat actors used an administrative bypass, structured query language and remote code execution vulnerabilities during the attack. The agencies said the actors gained initial access, obtained credentials and implanted webshells on victim networks.
    • “These attacks serve as another reminder of the importance of patch management in defending networks,” said Scott Gee, AHA deputy national advisor of cybersecurity and risk. “Think of this as a thief using bolt cutters to get through a perimeter fence, using a pry bar to force the door to the building open, and then using a hammer to break the glass protecting the jewels they came to steal. The good news for network defenders in this instance regarding Ivanti is that each of these tools can be detected.”
    • “CISA and the FBI strongly encouraged network administrators to upgrade to the latest supported version of Ivanti CSA.
    • “Any hospitals still using outdated versions of Ivanti CSA should update their systems immediately,” Gee said. “If unable to remove the outdated version, network security teams should implement detections based on the indicators of compromise in the advisory and understand the risk posed by this vulnerable technology.”
  • Cyberscoop notes,
    • “Researchers at Black Lotus Labs have uncovered an operation where a back door is dropped onto enterprise-grade Juniper Networks routers and listens for specific network signals, known as “magic packets,” to execute malicious commands. 
    • “The campaign, which researchers at the cybersecurity wing of Lumen Technologies refer to as “J-Magic,” was active between mid-2023 and mid-2024. The malware uses a custom variant of the open-source backdoor ‘cd00r,’ which operates invisibly to lay the groundwork for a reverse shell attack. The malware scans for five different predefined parameters before activating. If any of these parameters or “magic packets” are received, the malware sends a confirmation request. Once confirmed, J-Magic establishes a reverse shell on the local file system, allowing operators to control the device, steal data, or deploy further malware.
    • “Although the specific method of transmission into these routers remains unclear, many targeted devices are configured as virtual private network (VPN) gateways. Lumen’s analysis found that approximately half of the routers affected during the campaign functioned as VPN gateways.  
    • “The strategic focus of J-Magic on routers underscores a level of stealth, given that routers are rarely monitored with security software. The malware specifically targets JunoOS, Juniper’s FreeBSD-based operating system.” 
  • Per Dark Reading,
    • Cisco has released a patch for a critical vulnerability found in its Cisco Meeting Management feature that could allow a remote, authenticated attacker to elevate themselves to administrator privileges on an affected device.
    • “Cisco Meeting Management is a management tool for Cisco’s on-premises meeting platform, Cisco Meeting Server. The management system allows users to monitor and manage meetings that are running on the platform through two user roles: the first is for administrators with full rein over the platform; and the second is for “video operators,” who only have access to the meetings and overview pages.
    • “The vulnerability, tracked as CVE-2025-20156 (CVSS score of 9.9), is located in the REST API and exists because “proper authorization” is not enforced on REST API users. Should an attacker send specially crafted API requests to a specific endpoint, they could exploit the vulnerability and allow an attacker to gain administrator-level control over edge nodes managed by Cisco Meeting Management.
    • “This poses a risk to businesses, as a threat actor with video operator access on the platform could exploit this vulnerability to give themselves administrator privileges, allowing them the ability to change configurations, add users, and more, according to the advisory.”
  • Per Bleeping Computer,
    • “SonicWall is warning about a pre-authentication deserialization vulnerability in SonicWall SMA1000 Appliance Management Console (AMC) and Central Management Console (CMC), with reports that it has been exploited as a zero-day in attacks.
    • “The flaw, tracked as CVE-2025-23006 and rated critical (CVSS v3 score: 9.8), could allow remote unauthenticated attackers to execute arbitrary OS commands under specific conditions.
    • “The vulnerability affects all firmware versions of the SMA100 appliance up to 12.4.3-02804 (platform-hotfix). * * *
    • “We strongly advise users of the SMA1000 product to upgrade to the hotfix release version to address the vulnerability.”
    • “Microsoft’s Threat Intelligence Center discovered the flaw, so more details about the exploitation activity and when it started might be shared by Microsoft at a later date.”
  • The Hacker News adds,
    • “The U.S. Cybersecurity and Infrastructure Security Agency (CISA) on Thursday placed a now-patched security flaw impacting the popular jQuery JavaScript library to its Known Exploited Vulnerabilities (KEV) catalog, based on evidence of active exploitation.
    • “The medium-severity vulnerability is CVE-2020-11023 (CVSS score: 6.1/6.9), a nearly five-year-old cross-site scripting (XSS) bug that could be exploited to achieve arbitrary code execution.
    • “Passing HTML containing <option> elements from untrusted sources – even after sanitizing them – to one of jQuery’s DOM manipulation methods (i.e. .html(), .append(), and others) may execute untrusted code,” according to a GitHub advisory released for the flaw.
  • Plus we learn friom Cyberscoop,
    • A critical security flaw has been identified and potentially exploited in SonicWall’s Secure Mobile Access (SMA) 1000 series appliances, sparking significant concern among cybersecurity experts and users worldwide. 
    • The vulnerability, registered as CVE-2025-23006, allows remote, unauthenticated attackers to execute arbitrary operating system commands under certain conditions. The issue specifically impacts the Appliance Management Console (AMC) and Central Management Console (CMC) used widely in enterprise and government networks for administrative functions.
    • SonicWall issued a warning Wednesday [January 22, 2025] saying the flaw has a severity rating of 9.8 out of 10 by the Common Vulnerability Scoring System (CVSS) and may have been exploited by malicious actors. Microsoft’s Threat Intelligence Center is credited with uncovering the flaw, although it remains unclear when the exploitation might have commenced. Despite this, SonicWall’s advisory urges all SMA1000 users to upgrade immediately to the patched software version to prevent potential security breaches.
    • SonicWall’s products provide secure remote access for a wide swath of organizations, often serving managed security service providers (MSSPs), enterprises, and government agencies.
  • Bleeping Computer relates,
    • “The FBI warned today [January 23] that North Korean IT workers are abusing their access to steal source code and extort U.S. companies that have been tricked into hiring them.
    • “The security service alerted public and private sector organizations in the United States and worldwide that North Korea’s IT army will facilitate cyber-criminal activities and demand ransoms not to leak online exfiltrated sensitive data stolen from their employers’ networks.
    • “North Korean IT workers have copied company code repositories, such as GitHub, to their own user profiles and personal cloud accounts. While not uncommon among software developers, this activity represents a large-scale risk of theft of company code,” the FBI said.

From the ransomware front,

  • Cyberscoop reports,
    • “Researchers at cybersecurity firm Sophos are tracking multiple clusters of hacking activity leveraging Microsoft 365 instances, Microsoft Teams and email bombing tactics to deliver ransomware.
    • “In new research released Tuesday [January 21], the company said it had identified at least two distinct clusters of hacking activity using the tactics to infect targets between November and December 2024.
    • “First, several individuals at an organization are inundated with emails — up to 3,000 in 45 minutes in some cases. The sheer volume of spam is designed to overwhelm the target’s inbox and “create a sense of urgency” that may push them to reach out to IT for assistance, the researchers said.
    • “Then, using an external account, the hackers will message one of the targets over Microsoft Teams, posing as the organization’s IT support or a “Help Desk Manager.” Under the guise of assistance, the actors push the victim to permit a remote screen control session through Teams or Microsoft Quick Assist, which is then used to create command shells, access an external Sharepoint file and deploy malware on the victim’s device.
    • “With a command-and-control channel established, the attackers then use the target’s credentials to disable multifactor authentication and antivirus protections, connect to other hosts on the network and move laterally to compromise other systems.”
  • Cybersecurity News lets us know,
    • “New ransomware strains are quietly infiltrating VMware ESXi hosts by setting up SSH tunnels and concealing malicious traffic within legitimate activity.
    • “This stealth tactic allows attackers to access critical virtual machine environments without triggering many of the standard alarms or detection systems that monitor more conventional network paths.
    • “Because ESXi appliances often remain unmonitored, cybercriminals have seized the opportunity to hide in plain sight, exfiltrate data, and lock down virtual machines with minimal interference.
    • “Virtualized infrastructures are attractive targets for ransomware actors due to the high value of virtual machines and the rapid damage attackers can inflict if they seize control.
    • “Instead of compromising each guest system individually, criminals can focus on the ESXi host itself, enabling them to encrypt all virtual disks in one coordinated attack.”
  • Per the SentinelOne blog,
    • “The previous six months have seen heightened activity around new and emerging ransomware operations. Across the tail-end of 2024 and into 2025, we have seen the rise of groups such as FunkSec, Nitrogen and Termite. In addition, we have seen the return of Cl0p and a new version of LockBit (aka LockBit 4.0).
    • “Within this period of accelerated activity, the Ransomware-as-a-Service offerings HellCat and Morpheus have gained additional momentum and notoriety. Operators behind HellCat, in particular, have been vocal in their efforts to establish the RaaS as a ‘reputable’ brand and service within the crimeware economy.
    • “As a result of this recent activity, we analyzed payloads from both HellCat and Morpheus ransomware operations. In this post, we discuss how affiliates across both operations are compiling payloads that contain almost identical code. We take a high-level look at two samples in particular and examine their characteristics and behavior.” Check it out.

From the cybersecurity defenses front,

  • CISA advises,
    • “If you’re an IT defender or a vulnerability management pro, CISA’s Vulnrichment project can make your life easier. It enriches basic CVE data with actionable insights like Stakeholder-Specific Vulnerability Categorization (SSVC) decision points, Common Weakness Enumeration (CWE) IDs, and Common Vulnerability Scoring System (CVSS), all bundled into the CVE records you’re already pulling. Think of it as a turbocharged upgrade to the CVE data you’re already consuming. Best part? You don’t need to set up anything new—this enriched data is automatically baked into the CVE feeds you’re already using.
    • You’re soaking in it! Today, all Vulnrichment data ends up in the Authorized Data Publisher (ADP) container for individual CVEs, so if you’re pulling CVE data from https://cve.org via the API, or from GitHub at https://github.com/CVEProject/cvelistV5 ,  you’re already collecting Vulnrichment data. It’s just a matter of parsing it out.”
  • Check out Dark Reading for an article about MITRE’s Latest ATT&CK Simulations Tackle Cloud Defenses. The MITRE framework’s applied exercise provides defenders with critical feedback about how to detect and defend against common, but sophisticated, attacks.”
  • Security Week discusses attack surface management.
    • “The attack surface of an organization represents all of the assets (physical, virtual or human) that a malicious actor can potentially use to breach an organization,” says Alex Hoff, co-founder and chief strategy officer at Auvik Networks.
    • “Traditionally,” continues Raj Samani, SVP and chief scientist at Rapid7, “the focus of attack surface management has been on securing the broader attack surface – but the emphasis is now on preventing the exploitation of assets within increasingly complex environments.”
    • “While we have traditionally considered the Attack Surface to be a part of the overall IT infrastructure that can be treated and managed discretely, our view now is that the AS includes anything and everything a threat actor can target for exploitation.” 
  • Per Beckers Health IT,
    • “Global IT spending is expected to grow 9.8% in 2025, to $5.6 trillion, with much of that increase going to price hikes, according to Gartner.
    • “And while CIOs’ expectations for generative AI are on the wane — what the IT consultant called a “trough of disillusionment” — their spending on the technology will continue to rise, Gartner predicted. Those hardware upgrades will drive double-digit growth in data center systems, devices and software this year.”
  • Here is a link to Dark Reading’s CISO Corner.

Friday Report

Photo by JOSHUA COLEMAN on Unsplash

From Washington, DC

  • Govexec tells us,
    • “A 50-page document, compiled by GOP members of the House Budget Committee and first reported by Politico, outlines a list of provisions that could be included in the [budget reconciliation] package, which would not be subject to the Senate’s 60-vote filibuster threshold, includes a litany of proposals increasing federal workers’ contribution to their retirement and health care benefits, in exchange for worse payouts.” * * *
    • “On health care benefits, the House GOP proposes replacing the current system, by which the federal government pays for a percentage of health care premiums through the Federal Employees Health Benefits Program and the new Postal Service Health Benefits program, with a “voucher model.”
    • “Under this option, the FEHB and PSHB programs would be reformed by replacing the current premium-sharing structure with a voucher, which would not be subject to income and payroll taxes,” the document states.
    • “And the document calls for enactment of a bill introduced last year to require the Office of Personnel Management to audit FEHBP for improper enrollments. But OPM has said that under the current “decentralized” nature of the program, the agency does not have the capabilities to conduct such an audit.
    • “Prior to the presidential transition, then-President Biden’s OPM sent Congress a legislative proposal, drawn on lessons learned in launching the PSHB program this year, to revamp how it administers FEHBP so that it can conduct better oversight.”
    • FEHBlog observation — Better oversight starts with giving FEHBP and FEDVIP carriers the HIPAA 820 enrollment roster transactions that would allow them to reconcile individual enrollees with premiums paid.
  • MedPage reports,
    • “Legislation providing more scrutiny for pharmacy benefit managers (PBMs) that failed to make it through Congress in the waning days of 2024 seems to still be viable for passage this year, according to a House staff member.
    • “I think there’s plenty of political will there; that’s what I’ve seen from members,” Preston Bell, a professional staff member on the House Ways & Means Committee, said Thursday at an event sponsored by the American Enterprise Institute (AEI) on the future of the Medicare prescription drug benefit. “I do think there are disparate ideas across Congress as to how much intervention within the PBM market is appropriate. What you’ve seen come through Congress in the [massive continuing resolution] package [released and rejected in December 2024] is probably the litmus test, or maximum, of what is feasible for that type of reform.”
  • Healthcare Dive informs us,
    • “Sara Brenner, a Food and Drug Administration official in the agency’s medical device division, has been named the FDA’s acting commissioner, according to an update made online to the regulator’s leadership biography page. * * *
    • “Brenner will lead the agency until a permanent commissioner is installed. President Donald Trump has nominated Johns Hopkins surgeon Marty Makary as FDA commissioner, but he has not yet been confirmed by the Senate. Confirmation hearings for Robert F. Kennedy Jr., who, as Trump’s pick to run the Department of Health and Human Services, would be Makary’s boss, are scheduled for Jan. 29 and Jan. 30.
    • “Brenner worked in the FDA’s medical devices branch, most recently as chief medical officer for in vitro diagnostics and associate director for medical affairs. A preventive medicine physician, Brenner has been at the agency since 2019, according to her LinkedIn page, and helped coordinate diagnostic standards and policy as part of HHS’ COVID-19 response. 
    • “Brenner was previously a senior policy advisor at the White House Office of Science and Technology Policy under the first Trump administration.”
  • The Hill lets us know,
    • “The Food and Drug Administration (FDA) has withdrawn a rule that would have banned menthol cigarettes and flavored cigars, putting a formal end to a policy that had been indefinitely delayed under the Biden administration. 
    • “A regulatory filing showed the rule had been “withdrawn” on Jan. 21, President Trump’s second day in office. The move is a significant blow to public health groups who said banning menthol had the potential to save hundreds of thousands of lives, particularly among Black smokers.”
  • The IRS released its 2024 tax return edition of Publication 969 which concerns health savings accounts and other tax favored health plans.

From the judicial front,

  • Bloomberg Law reports,
    • “A former Johnson & Johnson executive’s allegations that the drug company overpaid for prescription drug benefits are “speculative and hypothetical,” and injuries she did suffer cannot be resolved by the court, a New Jersey federal judge ruled.
    • “The decision Friday dismissed most of Ann Lewandowski’s high-profile class action that argued the pharmaceutical giant violated its fiduciary duties under the Employee Retirement Income Security Act by not negotiating better drug prices with its pharmacy benefit manager, Express Scripts, or switching to a different PBM. 
    • “The lawsuit is one of several recent [actually it was the first] attempts to hold employers responsible through ERISA for monitoring and reducing health-care costs. The claims against J&J reveal that not even large drug companies are immune to complaints over high drug prices.
    • “Judge Zahid N. Quraishi in the US District Court for the District of New Jersey concluded that Lewandowski lacked standing to sue in dismissing two of her three claims. Lewandowski’s argument that J&J’s plan forced her to pay higher premiums and cost her higher wages was speculative “at best,” he said.
    • “And while Lewandowski did show that her copays for some drugs exceeded prices offered by other health plans, the court could not fulfill a key requirement for standing by making her whole, the judge said. Any amount refunded to her would have to go through the health plan for money it spent after she hit her out-of-pocket limit, Quraishi said.
    • “In straightforward terms, a favorable decision would not be able to compensate Plaintiff for the money she already paid,” he wrote.
    • “The judge did find that Lewandowski has standing to pursue her claim against J&J for not providing more information she requested around the plan’s drug prices, including the contract with Express Scripts, which was not a party to the suit. Quraishi invited Lewandowski to amend her complaint.”
  • The Wall Street Journal points out,
    • “Enforcement of the Corporate Transparency Act, which requires millions of companies to disclose their true ownership, remains on hold despite a U.S. Supreme Court ruling in favor of the Treasury Department. 
    • “The Supreme Court on Thursday overturned a lower court order that was blocking enforcement of the CTA. However, a separate national injunction issued earlier this month by a federal judge apparently remains in place and continues to block the law’s implementation.
    • “The Treasury’s Financial Crimes Enforcement Network, which is overseeing the law’s implementation, issued an alert Friday confirming compliance with the CTA isn’t mandatory while the injunction remains in force.” 
  • Fierce Healthcare relates,
    • “The Centers for Medicare & Medicaid Services has changed course on plans to appeal a court ruling that determined it must recalculate UnitedHealthcare’s Medicare Advantage star ratings.
    • “The agency submitted a filing in Texas district court earlier this week saying it intended to file an appeal to the Fifth Circuit Court. In new court documents filed Friday, CMS has withdrawn its notice of appeal.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • Seasonal influenza activity remains elevated across the country and is increasing in most areas. COVID-19 activity is elevated in many areas of the country. RSV activity has peaked in many areas of the country.
    • COVID-19
      • COVID-19 activity is elevated in many areas of the country, though wastewater levels are moderate, emergency department visits are at low levels, and laboratory percent positivity has declined in the last week. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • Influenza
      • Seasonal influenza activity remains elevated across the country and is increasing in many areas.
    • RSV
      • RSV activity has peaked in many areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • Vaccination
      • Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. COVID-19 vaccine coverage in older adults has increased compared with the 2023-2024 season. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.
  • BioPharma Dive relates,
    • “An experimental obesity drug from Novo Nordisk helped people lose an average of up to 22% of their body weight over 36 weeks in an early-stage trial, results that, if reproduced in further testing, could rival medicines Eli Lilly has on the market and in development.  
    • ‘Novo said Friday it is planning “further clinical development” of the drug, called amycretin, but didn’t specify the design of additional trials or when they might begin. Amycretin affects the same two targets as a Novo drug called cagrisema that recently missed expectations in a Phase 3 trial but does so in a single molecule rather than a two-drug combination.”
       
  • Per Healio,
    • “Integrating lifestyle care into low back pain management resulted in greater improvements in disability, weight loss and physical quality of life vs. just guideline-recommended care, a randomized study showed.
    • “The findings, published in JAMA Network Open, “could influence future updates to back pain guidelines,” Emma Mudd, PhD, senior research officer at the University of Sydney in Australia and the analysis’ lead author, said in a press release. “Patients valued the holistic support, and the outcomes speak for themselves.”
  • Earlier this week, the CVS Health Foundation announced $4 million in grants related to its health aging initiative.

From the U.S. healthcare business front,

  • Beckers Hospital Review notes,
    • “Mayo Clinic’s chief executive said at the World Economic Forum’s annual meeting in Davos, Switzerland, that he is fully committed to the adoption of artificial intelligence in healthcare, the Rochester (Minn.) Post Bulletin reported.
    • “I personally would not want to have my healthcare, in some specialties, without AI because I firmly believe I will get a better outcome,” said Gianrico Farrugia, MD, president and CEO of the Rochester-based health system, according to the newspaper’s coverage of the event Jan. 22.
    • “Mayo Clinic has been at the forefront of developing and deploying healthcare AI, with 320 algorithms in use, the news outlet reported.”
  • Beckers Payer Issues adds,
    • Insurers do not have to own every part of the healthcare system to improve connection, according to Jim Boyman, vice president of GuideWell Health. 
    • GuideWell is the parent company of Florida Blue. In December, the company launched an initiative to manage cancer care for Florida Blue ACA members. Through a partnership with Cerritos, Calif.-based The Oncology Institute and primary care organization Sanitas, Florida Blue members diagnosed with cancer will be connected with an oncology team to manage a personalized treatment plan. 
    • “Everyone talks about how fragmented healthcare is,” Mr. Boyman told Becker’s. “This shows how you don’t necessarily have to own all parts of the system to reduce that fragmentation. You can use technology and relationships to collaborate and overcome fragmentation through programs like this.” 
  • Fierce BioTech reports,
    • “Neomorph is building out its supply of Big Pharma partnerships, this time stamping down an option-to-license pact with AbbVie that centers around the biotech’s molecular glue platform.
    • “AbbVie will pay the San Diego biotech an undisclosed upfront sum and offer up to $1.64 billion in option fees and milestones, plus royalties, according to a Jan. 23 release.
    • “The new partners will look to develop molecular glue degraders—a novel class of small molecules designed to selectively degrade proteins that drive disease—for multiple targets across oncology and immunology.
    • “Protein degraders represent a groundbreaking advancement in the field of drug discovery and at AbbVie we are committed to advancing this technology forward,” Steven Elmore, Ph.D., AbbVie’s vice president of small molecule therapeutics and platform technologies, said in the release. “We are excited to collaborate with Neomorph to develop novel molecular glue degraders that could pave the way for new, effective therapies in the treatment of immune disorders and cancer.”
    • “Neomorph emerged in 2020 and quickly garnered a neuro deal worth up to $1.45 billion in biobucks with Biogen, plus a partnership with Novo Nordisk that offers up to $1.46 billion.” 
  • Per Fierce Healthcare,
    • “Self-funded employer health plan Centivo is announcing Centivo Care, a tech-forward virtual primary care platform integrated with behavioral health specialists.
    • “Centivo’s virtual offerings, which will be available in states where the company operates, are increasingly desired by its clients’ members, said Wayne Jenkins, M.D., chief medical officer for Centivo and president of Centivo Care, in an interview with Fierce Healthcare.
    • “He said at first, just 5% to 10% of people preferred the virtual option, but now it’s closer to 20%. For some employers, they see an even higher adoption rate. One of its clients, JetBlue Airlines, sees high utilization since their employees travel so often and can more easily text with a physician or schedule a video call than attend an appointment in person.
    • “Centivo Care is one of few primary care practices to earn a Patient-Centered Medical Home accreditation from the National Committee for Quality Assurance, the company said in a news release. These virtual appointments are free, and members receive personalized care plans, after-visit summaries, preventive care reminders and more.”
  • Per Beckers Hospital Review,
    • Telehealth utilization grew across most U.S. regions in October 2024, with the Midwest as the sole exception, according to FAIR Health’s monthly telehealth regional tracker.
    • Nationally, telehealth claim lines increased from 4.80% of medical claim lines in September to 4.89% in October, marking a 2% rise. Regional increases varied, with the West seeing the largest growth at 2.8%, while the Midwest experienced a 3.7% decrease.
    • Here are four things to know about telehealth utilization, according to FAIR Health’s tracker:
      • Psychiatric nurses moved up to the second-most common telehealth specialty nationally in October, overtaking family practice, which fell to fourth place.
      • Mental health conditions remained the leading telehealth diagnostic category nationally and regionally. 
      • The tracker revealed modest differences in telehealth costs compared to office visits. For instance, the median cost for a nutritional therapy reassessment was typically $1 to $2 lower via telehealth than in-office, except in the West, where telehealth costs were slightly higher.
      • Telehealth usage was highest among patients aged 31–40, followed by those aged 19–30, a pattern consistent across all regions.

Thursday Report

Photo by Josh Mills on Unsplash

From Washington, DC

  • Per a Senate press release,
    • “U.S. Senate Democratic Whip Dick Durbin (D-IL) today delivered a speech on the Senate floor highlighting his Drug-price Transparency for Consumers (DTC) Act, a bill he is introducing with Senator Chuck Grassley (R-IA) that would require price disclosures on advertisements for prescription drugs in order to empower patients and reduce Americans’ colossal spending on medications. The Government Accountability Office (GAO) has found that prescription drugs advertised directly to consumers accounted for 58 percent of Medicare’s spending on drugs between 2016 and 2018, while a 2023 study in the Journal of the American Medical Association found that two-thirds of advertised drugs offered “low therapeutic value.” By requiring direct-to-consumer (DTC) advertisements for prescription drugs to include a disclosure of the list price, patients can make informed choices when inundated with drug commercials and pharmaceutical companies may reconsider their pricing and advertising tactics.  In recent years, the pharmaceutical industry has sued to keep the prices of their drugs out of their TV advertisements.”
  • Politico reports,
    • Republican funding leaders have made an opening offer to Democrats as the two parties launch negotiations toward a deal to fund the government before the mid-March shutdown deadline.
    • Congress’ top appropriators gathered privately Thursday evening in the Capitol for an hour-long “four corners” meeting — the first concrete step toward a bipartisan funding agreement as Republican leaders begin to embrace the idea of a cross-party accord that funds the government and raises the debt limit, while also potentially boosting disaster aid and border security funding. The beginning of negotiations follows months of inaction on a bipartisan government funding plan, after lawmakers first punted beyond the October start of the fiscal year and then again resorted to a stopgap measure in December, pushing the spending cliff into the first months of the new Trump administration.
  • Federal News Network tells us,
    • “Agencies have until the end of the day Friday to revise their telework policies and begin ordering federal employees to work onsite full-time, according to a return-to-office memo from the Office of Personnel Management Wednesday evening.
    • “OPM is recommending agencies target a 30-day deadline to be in full compliance with the return-to-office directive President Donald Trump signed on his first day in office. Trump’s executive order told agencies to return their federal employees to work at the office “as soon as practicable.” The order also called for agencies to end “remote work arrangements” and require employees to work in person full-time, while leaving room for some exemptions.”
  • FedSmith lets federal and postal employees know the best dates to retire in 2025.
  • Per an OFCCP news release,
    • On January 21, 2025, the White House and President Donald Trump issued an Executive Order: “Ending Illegal Discrimination and Restoring Merit-Based Opportunity”, which revoked Executive Order 11246. For 90 days from the date of this order, Federal contractors may continue to comply with the regulatory scheme in effect on January 20, 2025.  
    • The Office of Federal Contract Compliance Programs shall immediately cease:
      • Promoting “diversity”.
      • Holding Federal contractors and subcontractors responsible for taking “affirmative action”; and
      • Allowing or encouraging Federal contractors and subcontractors to engage in workforce balancing based on race, color, sex, sexual preference, religion, or national origin.
    • It is important to note that requirements under Section 503 of the Rehabilitation Act, 29 U.S.C. 793, and the Vietnam Era Veterans’ Readjustment Assistance Act (VEVRAA), 38 U.S.C. 4212, both enforced by OFCCP, are statutory and remain in effect.

From the judicial front,

  • MedPage Today informs us,
    • “Members of the family who own Purdue Pharma, the maker of oxycodone hydrochloride (OxyContin), and the company itself, agreed to pay up to $7.4 billion in a new settlement to lawsuits over the toll of the powerful prescription painkiller, New York Attorney General Letitia James announced Thursday.
    • “The deal, agreed to by Purdue Pharma, the Sackler family members who own the company, and lawyers representing state and local governments and thousands of victims of the opioid crisis, represents an increase of more than $1 billion over a previous settlement deal that was rejected last year by the U.S. Supreme Court.
    • “The Sacklers agreed to pay up to $6.5 billion, Purdue to pay $900 million, for a total of $7.4 billion.
    • “It’s among the largest settlements reached over the past several years in a series of lawsuits by local, state, Native American tribal governments, and others seeking to hold companies responsible for a deadly epidemic. Aside from the Purdue deal, others worth around $50 billion have been announced — and most of the money is required to be used to stem the crisis.
    • “The deal still needs court approval, and some of the details are yet to be ironed out. An arm of the Department of Justice opposed the previous settlement, even after every state got on board, and took the battle to the U.S. Supreme Court. But under President Donald Trump, the federal government is not expected to oppose the new deal.”
  • The Washington Post reports,
    • The Supreme Court cleared the way Thursday for a major corporate transparency law that requires millions of businesses to make new ownership disclosures in an effort to combat financial crimes.
    • The high court lifted a block on the enforcement of the Corporate Transparency Act while a federal Circuit Court of Appeals based in New Orleans weighs the law’s constitutionality.
    • “The act, which passed in 2021, requires most U.S. businesses to disclose which of its owners control more than 25 percent of the stock or hold a similar stake in equity. The law aims to expose bad actors who create shell companies to disguise their identities while carrying out money laundering, tax fraud, drug trafficking or the financing of terrorism. It would affect more than 32 million businesses.”
  • Per Fierce Healthcare,
    • “An arbitrator has determined Prime Therapeutics violated federal and state antitrust laws against the AIDS Healthcare Foundation (AHF) and independent pharmacies.
    • “In a ruling (PDF) handed down Jan. 17, the AHF was awarded more than $10 million and injunctive relief after Prime Therapeutics was found to engage in horizontal price-fixing with Cigna’s pharmacy benefit manager (PBM), Express Scripts.
    • “Prime is a PBM owned by Blue Cross Blue Shield state plans. It has more than 20 million patients in its network affected by the collaboration.
    • “Prime was told to end its reimbursement structure for drugs under a long-standing collaboration with Express Scripts and to reimburse underpayments since June 30. The cozy relationship between Prime and Express Scripts allowed Prime to reimburse drugs and services the AHF provides to health plans, where Prime is the PBM, at a lower rate.”

From the public health and medical research front,

  • The New York Times reports,
    • “A study of more than 30,000 British adults diagnosed with attention deficit hyperactivity disorder, or A.D.H.D., found that, on average, they were dying earlier than their counterparts in the general population — around seven years earlier for men, and around nine for women.
    • “The study, which was published Thursday in The British Journal of Psychiatry, is believed to be the first to use all-cause mortality data to estimate life expectancy in people with A.D.H.D. Previous studies have pointed to an array of risks associated with the condition, among them poverty, mental health disorders, smoking and substance abuse.
    • “The authors cautioned that A.D.H.D. is substantially underdiagnosed and that the people in their study — most of them diagnosed as young adults — might be among the more severely affected. Still, they described their findings as “extremely concerning,” highlighting unmet needs that “require urgent attention.”
    • “It’s a big number, and it is worrying,” said Joshua Stott, a professor of aging and clinical psychology at University College London and an author of the study. “I see it as likely to be more about health inequality than anything else. But it’s quite a big health inequality.”
  • The American Hospital Association News notes,
    • “Perinatal mental health disorders affect countless mothers during pregnancy and postpartum, yet access to comprehensive care remains a challenge. Hospitals are stepping up to fill this gap, creating innovative programs that address the unique mental health needs of mothers during this critical period. A recent panel hosted by the AHA and the Policy Center for Maternal Mental Health highlighted the efforts of two trailblazing hospitals: Woman’s Hospital in Baton Rouge, La., and the University of Colorado Hospital Anschutz Medical Campus. READ MORE.” 
  • Per MedPage Today,
    • “Early Alzheimer’s pathology was not consistently linked to depressive symptoms in people without clinical dementia, cross-sectional data suggested.
    • “In people with normal cognition, depressive symptoms and amyloid pathology were not associated with each other (OR 1.13, 95% CI 0.90-1.40, P=0.29), reported Julie Oomens, PhD, of Maastricht University in the Netherlands, and co-authors.
    • “However, in people with mild cognitive impairment, the presence of depressive symptoms was tied to a lower likelihood of amyloid pathology (OR 0.73, 95% CI 0.61-0.89, P=0.001), Oomens and colleagues said in JAMA Psychiatry.
    • “The findings suggest that other mechanisms may underlie the previously seen associations between depressive symptoms and cognitive decline in late life, Oomens and colleagues observed.
    • “This large-scale study including data from 49 cohorts included in the Amyloid Biomarker Study shows that depressive symptoms were not consistently associated with a higher frequency of amyloid pathology in persons without dementia,” Oomens told MedPage Today. “This means that the earlier identified association between depressive symptoms and cognitive decline is likely not explained by Alzheimer’s disease pathology.”
  • and
    • Considering a risk score generated from multiple genetic variants linked to chronic obstructive pulmonary disease (COPD) caught undiagnosed cases of the disease better than conventional risk factors and respiratory symptoms alone, a study showed.
    • Adding the COPD polygenic risk score (PRS) to the Lung Function Questionnaire clinical risk score significantly improved the area under the curve by 0.03 to 0.06, suggesting a 3 to 6 percentage point increase in accuracy in identifying spirometry-defined, moderate to severe COPD, as researchers led by Matthew Moll, MD, MPH, of Brigham and Women’s Hospital and Harvard Medical School in Boston, reported in JAMA.
  • and
    • “Intermittent explosive disorder (IED), characterized by impulsive aggression and poorly regulated emotional control, was associated with multiple classes of comorbidities, an analysis of 117.7 million healthcare records showed.
    • “Of 30,000 individuals with an IED diagnosis during their lifetime, 95.7% had at least one other psychiatric diagnosis, reported Yanli Zhang-James, MD, PhD, of SUNY Upstate Medical University in Syracuse, and co-authors in JAMA Psychiatry.
    • “All psychiatric subcategories and 92% of psychiatric diagnoses were significantly associated with IED, with hazard ratios (HRs) ranging from 2.1 for substance use disorder to 76.6 for disorders of adult personality and behavior.”
  • Per tctMD,
    • “Patients who have hypertension while lying down, even if their blood pressure is normal while sitting up, have greater CVD and mortality risks in the decades to come, according to an analysis of the Atherosclerosis Risk in Communities (ARIC) study.
    • “Through more than 25 years of follow-up, supine hypertension was associated with greater risks of fatal and nonfatal coronary heart disease, heart failure, stroke, and all-cause death, lead author Duc Giao, MD (Harvard Medical School, Boston, MA), and colleagues report in a study published online Wednesday in JAMA Cardiology.
    • “The results didn’t differ based on whether patients were taking antihypertensive medications or whether they also had seated hypertension. Although risks of adverse outcomes were greatest in patients with both seated and supine hypertension, those with high supine BP alone carried greater hazards compared with those with elevations only when seated.
    • “Our conclusion was that not only is supine blood pressure an important risk factor for cardiovascular disease, but also it’s possible we could be missing a high-risk state by simply focusing on the seated position,” senior author Stephen Juraschek, MD, PhD (Beth Israel Deaconess Medical Center and Harvard Medical School), told TCTMD. “There might be more information to be gathered when we lie people flat and measure their blood pressure in the lying position.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “UnitedHealth Group has named Tim Noel as the next CEO of UnitedHealthcare, replacing Brian Thompson, who was killed in New York City in December.
    • “Noel has been at the health care conglomerate since 2007 and most recently led UnitedHealthcare’s Medicare division — one of the company’s most important and profitable lines of health insurance. Its Medicare Advantage and Medigap supplemental plans made up almost half of UnitedHealthcare’s $300 billion of revenue last year.”
  • Per Healthcare Dive,
    • “Elevance’s profits took a serious hit in the fourth quarter of 2024, falling to $418 million — down more than half from $856 million in the prior-year period — amid higher medical costs in the safety-net Medicaid program, according to financial results released Thursday morning.
    • “Yet the insurer’s earnings were in line with analyst expectations after a hard year. Investors also found reason for optimism in revenue growth, with Elevance’s topline of $45 billion up about 6% year over year. Elevance’s stock, and shares in managed care peers, rose in Thursday morning trading following the results.
    • “Still, Elevance’s guidance for 2025 implies the insurer expects spending to remain elevated this year, and some market watchers are concerned about the health of Elevance’s growth outlook for privatized Medicare plans — another source of shrinking margins.”
  • On a related note, Kaufmann Hall discusses the “Next Phase of Inorganic Payer Growth.”
  • Modern Healthcare adds,
    • “The number of Chapter 11 bankruptcy filings in healthcare dropped significantly in 2024 from the previous year, though filings still hit historically high levels.
    • “Fifty-seven healthcare companies with more than $10 million in liabilities filed for bankruptcy protection in 2024, the second-highest level since 2019, according to a report released Thursday from Gibbins Advisors. But the 2024 total is still down from 79 filings in 2023.
    • “Pharmaceutical companies topped the list with 14 bankruptcy filings, followed by 11 senior care companies and 10 clinics and physician practices. Bankruptcy filings for clinics and physician practices hit the highest level in the past six years, according to the report.
    • “Five hospital groups filed for bankruptcy protection in 2024, compared with 12 groups in 2023. However, one of those groups, Steward Health Care, involved more than 30 hospitals and marked the largest bankruptcy in the hospital sector in decades, the report noted.”



Midweek Report

Photo by Juliane Liebermann on Unsplash
  • From a Senate news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) will hold a nomination hearing on WednesdayJanuary 29, at 10:00AM to consider Robert F. Kennedy Jr. to be Secretary of the U.S. Department of Health and Human Services.” 
  • In the meantime, Dorothy Fink is serving as acting HHS Secretary.
  • FedWeek shares “the key portions of the guidance from OPM on the federal hiring freeze issued by the new Trump administration that addresses issues including general and special exceptions, movement and promotions of current employees and a prohibition on using contractors to fill vacated positions.”
  • The President issued an executive order revoking the affirmative action requirements of E.O. 11246 which President Lyndon Johnson signed in 1965. This action relieves federal government contractors and subcontractors with a contract valued at $100,000 or more and 50 employees or more of the burden to develop and implement a detailed affirmative action program. These businesses remain subject to federal and state laws prohibiting discrimination in employment, e.g., Title VII of the 1964 Equal Employment Opportunity Act.
  • The American Hospital Association News reports,
    • “The Department of Health and Human Services Health Resources and Services Administration is accepting applications until April 22 for its four-year Rural Maternity and Obstetrics Management Strategies Program. HRSA will award up to three cooperative agreements for up to $1 million per year for establishing rural obstetric networks to improve maternity care and access in rural communities. The program runs from Sept. 30, 2025, through Sept. 29, 2029.”

From the judicial front,

  • Per Fierce Healthcare,
    • “The feds intend to appeal a judge’s decision that would force them to recalculate UnitedHealthcare’s Medicare Advantage (MA) star ratings.
    • “The Centers for Medicare & Medicaid Services (CMS) submitted a filing Tuesday in Texas district court saying that it would appeal the November ruling to the Fifth Circuit Court of Appeals. Further details were not included in the court filing.
    • “Judge Jeremy Kernodle of Texas’ Eastern District Court ruled on Nov. 22 that the CMS would have to recalculate UnitedHealth’s MA scores. 
    • “At the center of the case is a single foreign language test phone call that was made to one of UnitedHealthcare’s call centers. The CMS categorized the call as “unsuccessful” because it was disconnected before the test caller could fully engage with a customer service agent, according to UnitedHealth’s lawsuit, which was filed in early October.
  • The Groom Law Group discusses pending ERISA litigation.

From the public health and medical research front,

  • USA Today reports,
    • “The beer, spirits and wine industries were already prepared for a continued lull in sales for 2025, then came the U.S. surgeon general’s call for cancer warning labels on alcoholic beverages.
    • “Add that buzz kill to a flight of other challenges facing the booze business: Dry January – and its sober-curious companion in fall, Sober October – along with the thriving year-round embrace of lower-alcohol and non-alcohol options, especially by younger consumers.
    • “Suddenly, moderation is sweeping the nation. Nearly half of Americans (49%) say they plan to drink less in 2025 – up from 41% who said that was their plan in 2024, according to a new survey, released Tuesday, commissioned by advertising and sales measurement technology firm NCSolutions.”
  • STAT News tells us,
    • “Immune checkpoint inhibitors, drugs that can help make the immune system recognize and destroy cancer more aggressively, are one of the most important medicines in cancer treatment today. Merck’s Keytruda has been used against dozens of different cancers in millions of patients, making it the top-selling drug in the world, with over $25 billion in revenue in 2023. Opdivo, from Bristol Myers Squibb, earned $10 billion in 2023.
    • “Now, a new class of drugs may be emerging to challenge the dominance of these first-generation checkpoint inhibitors. Experts said a certain type of bispecific antibody seems to have hit upon a crucial combination of two cancer targets: the proteins VEGF and either PD-1 or PD-L1. “It’s exactly that,” said Özlem Türeci, the CMO and co-founder of BioNTech. “I think that the anti-PD-1 or PD-L1 and VEGF concept can be a very broad, pan-tumor platform: the next-generation checkpoint modulator.”
  • MedPage Today informs us,
    • “Beneficial pediatric obesity treatment response was associated with a reduced risk of obesity-related events in young adults, a nationwide prospective cohort study in Sweden showed.
    • “Compared with poor response, good response to obesity treatment was associated with lower risk of type 2 diabetes (adjusted HR [aHR] 0.42, 95% CI 0.23-0.77), dyslipidemia (aHR 0.31, 95% CI 0.13-0.75), and bariatric surgery (aHR 0.42, 95% CI 0.30-0.58), reported Emilia Hagman, PhD, of the Karolinska Institute in Sweden, and colleagues.”
    • “Obesity remission showed similar reduced risks, as well as reduced risk of hypertension (aHR 0.40, 95% CI 0.24-0.65). Good response in obesity treatment or obesity remission was associated with a reduced risk of mortality (aHR 0.12, 95% CI 0.03-0.46), though treatment response was not associated with reduced risk for depression or anxiety, they noted in JAMA Pediatrics.
    • “The long-term effects of treating obesity in childhood were largely unknown,” Hagman told MedPage Today in an email. “Many people believe that because maintaining weight loss is so challenging, early treatment might not make a real difference in reducing the risk of serious health problems like type 2 diabetes, high blood pressure, or heart disease later in life. Our research helps answer this critical question and shows the importance of addressing obesity early.”
  • HCPLive adds,
    • “Patient factors, including sociodemographic, healthcare, and clinical elements, were linked to the initiation of semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), in a population with obesity without type 2 diabetes (T2D).1
    • “Among more than 97,000 commercially insured adults in a recent cohort study, approximately 2.0% began semaglutide treatment within 6 months of an obesity diagnosis, with sex, insurance plan, and medication use found to be relevant factors for medication initiation.
    • “The association of these factors with semaglutide initiation were quantified using multivariable logistic regression, and use of common medications, insurance plan structure, employer industry type, and sex were all significantly associated with semaglutide initiation,” wrote the investigative team, led by Andrew C. Stokes, PhD, department of global health, school of public health, Boston University.”

From the U.S. healthcare business front,

  • Healthcare Dive relates,
    • “Johnson & Johnson on Wednesday reported modestly higher-than-expected earnings for the fourth quarter, while cautioning that unfavorable currency exchange rates would temper sales growth this year.
    • “Adjusted earnings per share reached $2.04 in the fourth quarter, higher than the Wall Street consensus of $2.01 and Leerink Partners’ estimate of $1.96, Leerink analyst David Risinger wrote in a note to clients. The company’s sales rose 5.3% to $22.5 billion during the quarter, in line with estimates
    • “Full-year 2024 revenue increased to $88.8 billion from $85.2 billion in 2023. For this year, J&J expects revenue to climb to between $89.2 billion and $90 billion, with a mid-point of $89.6 billion, less than the consensus estimate of $91.1 billion. Shares of the company dropped about 3% in early trading Wednesday, even as the overall market rose.”
  • BioPharma Dive adds,
    • “Johnson & Johnson expects changes in Medicare’s prescription drug benefit will negatively impact its sales by about $2 billion this year, a modest headwind for a pharmaceuticals division the company anticipates will otherwise continue growing.
    • “The changes are the result of a redesign under the Inflation Reduction Act to Medicare’s Part D benefit, which covers outpatient drug treatment. The 2022 law capped annual out-of-pocket spending by people enrolled in Part D to $2,000 beginning this year, and required drugmakers provide additional discounts within certain phases of coverage, among other tweaks.
    • “J&J provided its estimate of the redesign’s financial impact Wednesday alongside earnings for the fourth quarter. In doing so, the company follows Pfizer, which late last year forecast the changes would have a $1 billion net negative impact on 2025 revenue.
    • “The Part D redesign brought on by the Inflation Reduction Act is proving consequential to drugmakers’ business even as the law’s provisions allowing Medicare to negotiate certain drug prices get more attention. Three drugs marketed in whole or in part by J&J were picked by the Biden administration for the first round of negotiations that wrapped up last summer.”
  • The American Hospital Association News points out,
    • “Baxter notified customers on Jan. 22 that allocations for two sodium chloride IV solutions have been increased to 100%. According to Baxter, the products will have a one- to two-week lag time while they progress through the full distribution network after implementing changes. AHA members have notified the association of two- to three-week lag times in some cases following previous allocation updates.”
  • Per Fierce Healthcare,
    • “Credit downgrades for nonprofit hospitals again outpaced upgrades across 2024, though the difference between the two narrowed compared to the year before, according to a review of three credit agencies’ rating actions published Wednesday.
    • “Moody’s, S&P and Fitch collectively issued 95 downgrades and 37 upgrades in 2024, as opposed to 116 and 33 in 2023, wrote Kaufman Hall Managing Director Lisa Goldstein.
    • “She and her firm expect the trend to continue into 2025 “given a growing reliance on government payers, labor challenges and a competitive environment.”
    • “Policy and funding changes will also cast uncertainty into the mix in 2025 and may cause credit deterioration in future years,” she wrote on Kaufman Hall’s website.”
  • Healthcare Dive adds, “Providers to target efficiency, supply chain resilience in 2025. Health systems will work to expand their supply chains and ink nontraditional partnerships in 2025, while trimming excessive AI programs and nonclinical staff.”
  • Meanwhile MedTech Dive notes, “AI in medtech is taking off. Here are 4 trends to watch in 2025. New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain around insurance coverage and generative AI.”
  • Per a news release,
    • The Institute for Clinical and Economic Review (ICER) today announced a new analysis it plans to release on an annual basis titled the “Launch Price and Access Report” which will examine launch pricing for FDA-approved treatments. This report will review the affordability and access of the treatments and their value to the overall health system.
    • “There is no better time to provide an independent analysis on trends in launch pricing – both list and net – and patient access,” stated ICER’s Vice President of Research Foluso Agboola, MBBS, MPH. “ICER typically evaluates promising treatments that pose potential affordability challenges for the U.S. health system. Through this work, ICER will continue to work towards a health system where the pricing of innovative treatments are tied to value, while still ensuring affordability and access for patients.”  * * *
    • “The report is expected to be released in the fourth quarter of 2025.”
  • Alan Fein, in his Drug Channels blog, discusses “The Big Three PBMs’ 2025 Formulary Exclusions: Humira, Stelara, Private Labels, and the Shaky Future for Pharmacy Biosimilars.”

Tuesday Report

From Washington, DC,

  • The Hill reports, “Senate Republicans hit their full 53-member majority on Tuesday as Sens. John Husted (R-Ohio) and Ashley Moody (R-Fla.) were sworn into office by Vice President Vance.” 
  • Fierce Healthcare reviews how yesterday’s executive orders and other actions impact healthcare.
  • The U.S. Preventive Services Task Force highlights its most recent final recommendations.
  • Fierce Pharma tells us,
    • “Already on its way to becoming a blockbuster drug, Johnson & Johnson’s Spravato has received another potential boost as the FDA has blessed the nasal spray to be used as a monotherapy for major depressive disorder (MDD).
    • “Spravato was originally approved in 2019 to be used along with an oral antidepressant for patients who have not seen results with other antidepressant medications.
    • “In 2020, the U.S. regulator tacked on another nod for Spravato to be used by patients with MDD who experience acute suicidal thoughts or behavior.
    • “The standalone endorsement allows patients to use Spravato without taking oral antidepressants. Spravato can work as quickly as 24 hours, Bill Martin, Ph.D., who heads up J&J neuroscience, said in a release.
    • “Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them,” Martin added. “For too long, healthcare providers have had few options to offer patients much-needed symptom improvement.”
  • and
    • “After hitting a regulatory roadblock in 2022, Sanofi’s consumer healthcare business Opella has secured the FDA’s blessing to move forward with its ambition to convert its erectile dysfunction med Cialis into an over-the-counter product.
    • “The agency previously placed a clinical hold on the company’s planned actual use trial (AUT) for the conversion, citing problems with protocol design. AUTs are a key step in the FDA’s process for switching drugs from prescription to OTC products and are meant to prove that consumers can adequately diagnose and treat themselves without the help of a healthcare provider.
    • “Now, after a review, the FDA’s green light marks a “significant step forward in Opella’s data-driven efforts to switch a PDE-5 inhibitor like Cialis,” Opella’s chief science officer Josephina Fubera, Ph.D., said in a company release.
    • “We look forward to continuing our work to bring safe and expanded access to the many consumers who will benefit from nonprescription Cialis,” Fubera added.”

From the public health and medical research front,

  • The University of Minnesota’s CIDRAP lets us know today,
    • “Over the past few days, the US Department of Agriculture (USDA) confirmed more H5N1 avian flu outbreaks in poultry from eight states, including the first at a commercial farm in Georgia.
    • “Meanwhile, the Food and Drug Administration (FDA) and the USDA on January 17 announced new steps to step up the safety of raw pet food, following recent reports of H5N1 infections in household cats.”
  • and
    • “A new real-world study published in PLOS Medicine that looked at outcomes of 703,647 patients with COVID-19 seen at 34 US clinics in 2022 and 2023 found that Paxlovid use was correlated with lower rates of hospitalization and death, particularly among older patients. 
    • “Both vaccinated and unvaccinated patients benefitted from Paxlovid when administered within 5 days of COVID-19 infection confirmation, the authors said. But researchers observed lower rates of use among Black and Hispanic patients than among White patients. 
    • “The study was based on the National COVID Cohort Collaborative’s (N3C) electronic health record database. While clinical trials showed as high as an 88.9% reduction in the risk of COVID-related hospitalization or death among those who received Paxlovid compared to those who received placebos, limited real-world data has been gathered in the post-Omicron era on Paxlovid efficacy.”
  • Consumer Reports, writing in the Washington Post, discusses “What to look for — and what to avoid — in an energy bar. Many are little more than candy bars and don’t deliver the health benefits you might expect.”

From the U.S. healthcare business front,

  • RAND opines,
    • “The typical cost of developing new medications may not be as high as generally believed, with a few ultra-costly medications skewing public discussions about the cost of pharmaceutical research and development, according to a new RAND study.
    • “Using a novel method to assess spending on research and development for 38 drugs that were recently approved by the U.S. Food and Drug Administration, researchers found that the mean, or average, cost of developing a new drug was much higher than the mid-point (median) cost of development.
    • “Researchers estimated a median direct research and development cost of $150 million compared to a mean of $369 million.
    • “Costs were higher after adjusting for earnings drug developers could have made if they had invested these amounts in other activities and for drugs that never made it to the market. With these adjustments, researchers estimated a median research and development cost of $708 million across the 38 drugs examined, with the average cost rising to $1.3 billion driven by a small number of high-cost outliers.
    • “The average cost of developing a new drug was 26 percent lower when excluding just two drugs, dropping from $1.3 billion to $950 million. The findings are published in the journal JAMA Network Open.”
  • Employee Benefit News explains why “costly gene therapy is top of mind for benefits administrators.” Check it out.
  • Per Fierce Healthcare,
    • “Healthcare technology company Innovaccer announced its acquisition of Humbi AI, an actuarial software, services and analytics company used by providers, payers and life sciences companies.
    • “Innovaccer’s cloud powers a slew of healthcare AI features like an AI-assisted care management system, contract management, ambient documentation, pre-visit summary and AI-suggested differential diagnoses.
    • “Financial details of the deal were not disclosed.
    • “The Humbi AI acquisition will help build out Innovaccer’s data analytics capabilities. The Nashville-based company combines healthcare data analytics and actuarial consulting to help healthcare organizations improve value-based contracts, manage risk and design benefits.
    • “Humbi AI’s actuarial capabilities will be an integral component of Innovaccer’s cloud platform, and the company plans to launch its own actuarial copilot, executives said in a press release.”
  • Modern Healthcare adds,
    • “Digital health companies at last week’s J.P. Morgan Healthcare Conference weren’t just looking for investors. They were looking for dance partners.
    • “The desire of digital health companies to scale through mergers and acquisitions or partnerships was one of the most buzzed-about topics at the conference. Marissa Moore, principal at venture capital firm Omers Ventures, said potential buyers and sellers were trying to size up prospects during the event.
    • “People were soliciting us, ‘Hey, we’re trying to spin off this asset, do you know any good buyers?’ Every conversation we were having [at JPM] was an M&A conversation,” Moore said. “We were approached by corporate development executives from big tech companies…you could tell they were trying to get a pulse on what was struggling and what might fit into their growing portfolios, and where there might be an opportunity to partner.”
    • “That search was particularly active for companies selling digital health solutions to employers, a market that has become challenged as employers grapple with the rising cost of healthcare and low usage rates of their offerings. Employers are looking to reduce the number of companies they contract with to reduce costs and simplify the experience for their employees, said Jim Winkler, chief strategy officer at Business Group on Health, an industry group that represents large employers.”

Happy Martin Luther King, Jr., Day

The National Part Service reminds us, “Dr. Martin Luther King Jr. was a tireless advocate for racial equality, working classes, and the oppressed around the world. Commonly called Martin Luther King, Jr. Day or MLK Day, the third Monday of January is a federal holiday to honor his life and legacy.”  RIP

Donald J. Trump was sworn into office as the 47th President of the United States at noon today.

The Wall Street Journal reports, “President Trump signed an executive order creating the Elon Musk-led Department of Government Efficiency. “That’s a big one,” he exclaimed. Trump said Musk would get an office for about 20 staffers.” * * *

“Trump’s executive order calls on agencies to set up DOGE teams of at least four employees, which will include a team leader, an engineer, a human resources specialist and an attorney. Under the new structure, the United States Digital Service, which provides information technology services to federal agencies, will be renamed the United States DOGE Service with an administrator who will report to the White House chief of staff, Susie Wiles.”

President Trump also signed the following additional executive orders of relevance to federal employment and the FEHB Program —

The President formally nominated Scott Kupor of California to be OPM Director.

Rescission of the January 3 memorandum is understandable because the President named an OPM IT executive Charles Ezell to be acting OPM Director. Here is a link to Director Ezell’s first formal action in that role.

The House of Representatives and the Senate are in session this week for Committee business and floor voting. The Senate unanimously confirmed now former Senator Marco Rubio to be Secretary of State this evening.

The Senate committees will be holding confirmation hearings and meetings while committees in both Houses will be engaged in organizational activities. The Senate Homeland Security and Governmental Affairs held a business meeting this evening on whether to confirm the President’s nominee to Director of the Office of Management and Budget, Russell Vought. The Senate Budget Committee will hold a hearing on Mr. Vought’s nomination tomorrow. In the meantime, OMB Assistant Directors for Legislative Reference Matthew Vaeth is the acting OMB Director.

STAT News reports,

  • “A next-generation form of chemotherapy from AstraZeneca and Daiichi Sankyo has won Food and Drug Administration authorization for a form of breast cancer, the first U.S. approval for a drug for which the companies have high expectations. 
  • “The FDA on Friday announced it had approved the drug, to be marketed as Datroway, for certain advanced breast cancer patients. Datroway, also called datopotamab deruxtecan, or Dato-DXd, was approved in Japan for a form of breast cancer last month, its first regulatory green light.
  • “The U.S. list price for Datroway is roughly $4,900 per 100 milligram vial and the recommended dose of the drug is 6 milligrams per kilogram of patient weight every three weeks. 
  • “Datroway is what’s known as an antibody-drug conjugate, an emerging type of therapy that aims to deliver the powerful cancer-killing ability of chemotherapy directly to tumor cells, staving off the toxic side effects of standard chemo. AstraZeneca and Daiichi are also partnered on a top-selling ADC called Enhertu.”

MedPage Today lets us know

  • An observational study of 175 health outcomes using Veterans Affairs (VA) data for nearly 2 million individuals uncovered new insights about possible risks and benefits of GLP-1 receptor agonists.
  • “Over a median of 3.68 years, adults with type 2 diabetes who added a GLP-1 agent to their treatment plan had significantly decreased risks for 42 diverse outcomes, increased risks for 19 outcomes, and no association with 114 outcomes compared with usual care, reported Ziyad Al-Aly, MD, of Washington University in St. Louis, and colleagues.
  • “The results may be useful for informing clinical care, enhancing pharmacovigilance, and guiding the development of mechanistic and clinical research to evaluate the broad pleiotropic effects of GLP-1 receptor agonists,” the researchers wrote in Nature Medicine.
  • “GLP-1 agents “have an intricate web of various effects,” Al-Aly said in a press briefing. For example, the analysis showed that use of GLP-1 agonists was associated with a 5% risk reduction in neurocognitive disorders, driven by an 8% decreased risk of dementia and 12% lower risk for Alzheimer’s disease.
  • “It’s weak, but it’s not null,” Al-Aly said about the Alzheimer’s relationship, adding that this finding “is still welcome” given the limited number of treatments for the disease.”