From Washington, DC

• The Wall Street Journal reports,
  • “Big tobacco companies and their critics agree on at least one thing: The illegal, fruit-flavored, disposable vapes that are popular among teenagers have flooded the U.S. market and federal regulators haven’t done enough to stop it.
  • “The Food and Drug Administration and Justice Department said Monday they are stepping up enforcement by forming a multiagency task force to go after the illegal distribution and sale of e-cigarettes.
  • “Disposable vaping devices, almost none of which are authorized for sale by the FDA, represent more than 30% of U.S. e-cigarette sales in stores tracked by Nielsen, according to an analysis by Goldman Sachs. Many of them are imported from China. Breeze Pro and Elfbar, both of which were ordered off the market last year by the FDA, remain the top two disposable e-cigarette brands in the U.S.”

• Per BioPharma Dive,
  • “An experimental and closely watched medicine for Alzheimer’s disease is one step closer to approval, after receiving support from a panel of experts who advise the Food and Drug Administration. “An experimental and closely watched medicine for Alzheimer’s disease is one step closer to approval, after receiving support from a panel of experts who advise the Food and Drug Administration.
  • “On Monday, the panel unanimously voted that the medicine, developed by Eli Lilly and known as donanemab, appears to be an effective treatment for certain Alzheimer’s patients. The experts also concluded, by an 11-0 vote, that the drug’s benefits outweigh its risks, despite some safety concerns.
  • “I thought the evidence is very strong and the trials [show] the effectiveness of the drug,” said Dean Follman, a panelist and assistant director of biostatistics at the National Institute of Allergy and Infectious Diseases.”

• Federal News Network tells us,
  • “Postmaster General Louis DeJoy is billing the Postal Service’s survival from the worst days of the COVID-19 pandemic as an unsung comeback story — but the agency is still writing its next chapter, as it figures out how to stay financially healthy in the long term.
  • “DeJoy, speaking Monday at the National Postal Forum in Indianapolis, said he inherited a “broken business model” when he took office in June 2020 — and that the agency was months away from running out of cash at the height of the COVID-19 pandemic.
  • “Failure to adequately adapt to social, economic, technological, and industrial changes have destroyed giants in their industry – Kodak, Motorola, Blockbuster – in just a few short years,” DeJoy said in his keynote address. “The demands of the changes experienced by the Postal Service were magnitudes greater. In addition, these organizations did not have a Congress or a regulator to contend with.”
  • “Four years into his tenure as postmaster general, DeJoy is defending USPS changes under this 10-year reform plan — some elements of which USPS is temporarily pausing, after bipartisan scrutiny from Congress.”

From the public health and medical research front,

• BioPharma Dive lets us know,
  • “Moderna on Monday said a combination flu and COVID-19 shot it’s developing met the goal of a late-stage study, eliciting higher immune responses to the two viruses than did available vaccines when tested among adults 50 years or older.
  • “Dubbed mRNA-1083, the shot is made up of Moderna’s second-generation COVID vaccine and a candidate for influenza, which have each been tested on their own in separate trials. The company pit mRNA-1803 against Spikevax, its approved COVID vaccine, and against flu shots from drugmakers Sanofi and GSK.
  • “Moderna said the data showed a single dose of mRNA-1083 was statistically equivalent, or “non-inferior,” to giving those vaccines together. It plans to present full results at an upcoming medical meeting, and to discuss next steps with regulators.”

• STAT News reports,
  • “It’s a familiar scene for patients during a routine primary care visit. The doctor scans blood test results, notes high cholesterol flagged by a standard calculator to assess risk of heart attack or stroke, then decides — and ideally discusses — whether to recommend taking a statin to cut the risk over time.
  • “That conversation may happen less often if changes in the risk model presented by the American Heart Association in November translate into new guidelines for prescribing statins. Those guidelines haven’t been recalibrated yet, but a new analysis suggests that the new risk model could mean far fewer Americans — as many as 40% less than current calculators say — would be candidates for cholesterol-lowering drugs to prevent cardiovascular disease.”

• NBC News informs us,
  • “New research points to a better way to measure obesity than body mass index.” New research points to a better way to measure obesity than body mass index.
  • “Body mass index was first developed in 1832 and has been the standard way to estimate a person’s body fat since the 1980s. The calculation, however, has come under increasing scrutiny in recent years.
  • “One major critique of BMI is that it doesn’t look at how much of a person’s weight is fat, and where fat is distributed around the body. It also doesn’t take into account the other elements that make up a person’s body composition beyond fat, including muscle, bone, water and organs.
  • “Fat distribution and body composition can vary dramatically among different people with the same BMI,” Wenquan Niu, a professor at the Capital Institute of Pediatrics in Beijing, wrote in an email.
  • “Because muscle is much denser than fat, BMI skews higher in people who are very muscular but have less body fat, like athletes, Niu said. On the other end of the spectrum, BMI can be underestimated in older people with much less muscle mass and more body fat.
  • ‘In a study published last week in JAMA Network Open, Niu and his colleagues showed that a different measurement, called the body roundness index, is a more precise way to estimate obesity.”
  • While BMI estimates a person’s body fat using just two measurements, height and weight, BRI also incorporates hip and waist circumferences to estimate how much total fat and visceral fat someone has. Visceral fat is a type of deep belly fat that surrounds the organs and can be more harmful to health.

• Medscape offers an update on new oral weight loss drugs and tells us,
  • Fewer than one in five people eligible for lung cancer screening reported being up to date with screening in 2022, though patient navigation added to usual care could be a way of increasing these rates, according to two studies published in JAMA Internal Medicine.
  • Among nearly 26,000 respondents in a nationwide cross-sectional study, the overall prevalence of up-to-date lung cancer screening was 18.1% but varied across states (range 9.7% to 31%), with relatively lower rates in Southern states that have a high lung cancer mortality burden, noted Priti Bandi, PhD, of the American Cancer Society, and colleagues.

From the U.S. healthcare business front,

• The Altarum Institutes posted a report titled “Utilization and Price Drivers of Increasing Health Care Spending (2010-2023).”
  • “Following the 2022 slowdown in health care spending that led to the overall health care sector reaching its smallest share of the economy since 2014 (17.3%), there has been a gradual resurgence in health care spending beginning in early 2023. This resurgence, driven predominantly by the greater use of care (and particularly a return of elective and outpatient services), is following the pandemic-affected period of very slow spending growth, postponed care, and health care labor shortages from 2020 through 2022. Higher utilization has been observed in data such as our monthly Altarum health care spending and prices briefs, as well as other industry sources such as hospital and insurer financial reports. In this blog, we put 2023’s above-average health care utilization increases into perspective historically and break down utilization trends by the different major health care spending categories.
  • “Following the 2022 slowdown in health care spending that led to the overall health care sector reaching its smallest share of the economy since 2014 (17.3%), there has been a gradual resurgence in health care spending beginning in early 2023. This resurgence, driven predominantly by the greater use of care (and particularly a return of elective and outpatient services), is following the pandemic-affected period of very slow spending growth, postponed care, and health care labor shortages from 2020 through 2022. Higher utilization has been observed in data such as our monthly Altarum health care spending and prices briefs, as well as other industry sources such as hospital and insurer financial reports. In this blog, we put 2023’s above-average health care utilization increases into perspective historically and break down utilization trends by the different major health care spending categories.
  • Over the past fifteen years, rising U.S. health care spending has been driven both by increased utilization and higher prices, with utilization increases contributing more to higher spending (Figure 1). Since 2010, utilization of personal health care (spending on health goods and services, excluding spending on program administration, net cost of insurance, public health activities, and investment) has increased 47% (contributing about 60% of the overall spending growth), while underlying prices for care have increased 31%. Greater utilization since 2010 has been affected by increases in overall population rates of health insurance coverage, an aging population, greater direct government support for health care during the pandemic and increases in the intensity of care provided for many health care needs.” 

• Per MedTech Dive,
  • “Abbott said Monday it will launch two over-the-counter continuous glucose monitors after receiving clearance from the Food and Drug Administration.” Abbott said Monday it will launch two over-the-counter continuous glucose monitors after receiving clearance from the Food and Drug Administration.
  • “One product is the company’s Lingo device, sold as a wellness product for people who do not have diabetes. The other is Abbott’s new Libre Rio device, which is intended for adults with Type 2 diabetes who do not use insulin, posing a direct challenge to Dexcom’s Stelo device. 
  • “After Lingo was cleared last week, RBC Capital Markets analyst Shagun Singh wrote the over-the-counter nod could offer a more than $1 billion sales opportunity for Abbott.”

• Per Fierce Healthcare,
  • “Bobby Mukkamala, M.D., was voted in as president-elect of the American Medical Association (AMA) at the group’s annual meeting in Chicago. He will take over for immediate past president Jesse Ehrenfeld, M.D., whose last day in office is Tuesday, June 11. “Bobby Mukkamala, M.D., was voted in as president-elect of the American Medical Association (AMA) at the group’s annual meeting in Chicago. He will take over for immediate past president Jesse Ehrenfeld, M.D., whose last day in office is Tuesday, June 11. 
  • “Mukkamala will serve a one-year term for the physician advocacy group, which has been focused on reforming Medicare physician pay, reducing prior authorization burden and mitigating provider burnout, including through the use of technology to augment provider workflow. 
  • “Mukkamala is an otolaryngologist from Flint, Michigan, who has served in leadership roles within the American Medical Association and for local health initiatives in Michigan. He chairs the Substance Use and Pain Care Taskforce of the AMA and served on its board of trustees in 2017 and 2021.”
• and
  • “Thought leaders from across the insurance industry will descend on Las Vegas this week for AHIP’s annual conference, kicking off three days of discussions on the biggest issues facing payers.”
  • “The Fierce Health Payer team will also be making the journey to Sin City, so keep an eye out for our coverage over the next several days. Ahead of the event, here’s a look at three key trends we expect to hear plenty about across panels, keynotes and meetings.”
    • GLP-1 Drug Costs and Shortages Remain Center-Stage
    • Continued Talk about Implementation of Value-Based Care, and
    • Cutting through the AI Hype.

• Healthcare Dive adds,
  • “Teladoc Health has named a new CEO, months after the virtual care company’s long-term chief executive abruptly departed following flagging financial performance at the telehealth vendor.
  • “Charles “Chuck” Divita III will take on the role effective immediately, the company said Monday.
  • “His appointment comes about two months after Jason Gorevic, the former CEO who held the position since 2009, left the company.
  • “We are confident we have selected an innovative and visionary leader capable of delivering growth at scale, value for our clients and positive relationships with all our partners and colleagues,” David Snow Jr., chairman of Teladoc’s board of directors, said in a statement.
  • “Divita joins the virtual care company from GuideWell, a healthcare insurance and services company that includes Florida Blue, where he served as executive vice president of commercial markets and previously chief financial officer. He also worked as CFO at FPIC Insurance Group, which focuses on medical professional liability.”