From Washington, DC

• The Federal Times tells us,
  • “The federal government again processed a high number of retirement applications last month, even though its overall pace slowed.
  • “In March, the Office of Personnel Management packaged 680 more cases than it did the month before and took in about 850 fewer applications, chopping the backlog by 14%. The rate of processing was slightly slower than in February, but the average case is still being processed in roughly two months or less, which is OPM’s goal, according to the data.”

• STAT News reports,
  • “For decades, the Food and Drug Administration’s accelerated approval pathway has helped companies get drugs for serious unmet medical needs to patients — and the market — sooner. But about half of cancer drugs approved via this route fail to improve patient survival or quality of life in subsequent clinical trials after more than five years of follow-up, according to new findings presented Sunday at the American Association for Cancer Research annual meeting.
  • “The data come from an analysis of cancer drugs granted accelerated approval over the past decade. In some cases, failure to show clinical benefit didn’t stop the FDA from converting accelerated approvals into full approvals, and the authors note the agency’s conversion decisions have increasingly been based on less stringent evidence of a drug’s benefits.
  • “The study also found evidence that drugs granted accelerated approval, meant to be a temporary designation, are spending less time in limbo. In 2013, it took an average of 9.9 years after accelerated approval for cancer drugs to be pulled from the market if follow-up trials didn’t show a benefit; by 2017, that timing dropped to 3.6 years.
  • “The findings, presented during a press briefing at the AACR meeting, were also published in the Journal of the American Medical Association. The study’s authors say the results aren’t an argument against the use of drugs available via accelerated approval, but underscore the importance of doctors communicating both the potential benefits and uncertainty surrounding these products to patients. They urged drugmakers to more routinely collect quality-of-life data during confirmatory studies, and the FDA to press companies to gather stronger evidence of clinical benefit to support a drug’s full approval.”

From the public health and medical research front,

• The Washington Post and Consumer Reports explain what to do about jaw pain and when to worry.

• STAT News lets us know,
  • “Cancer cases among younger people have been rising for years, a trend researchers have struggled to explain. New evidence suggests a significant factor: younger generations seem to be aging faster at the cellular level than their predecessors.
  • “A team of scientists at Washington University in St. Louis tracked data from nearly 150,000 people between the ages of 37 and 54 in the U.K Biobank, a massive biomedical database. They used nine blood-based markers to calculate their biological age, a measure that captures the overall state of a person’s cells and tissues.
  • “Sharing results on Sunday here at the American Association for Cancer Research annual meeting, they found that people born after 1965 were more likely to have a biological age that outpaced their chronological age. People with higher levels of accelerated aging had a 17% increased risk of developing any solid tumor cancer, with higher risk increases for lung, gastrointestinal, and uterine cancer.”
• and
  • “A controversial heart pump from Abiomed reduced the number of deaths in severe heart attack patients, according to a highly anticipated randomized trial presented at the American College of Cardiology conference and published in the New England Journal of Medicine on Sunday.
  • “The trial, which took 10 years to enroll, followed 355 patients for 180 days in Denmark, Germany, and the United Kingdom who came into the hospital with a heart attack and dangerously low blood flow, known as cardiogenic shock. Half of the patients received standard care, which typically included medication and about 20% of the time included life support, and the other half received Abiomed’s left-sided heart pump, called the Impella, for 48 hours. * * *
  • “Though the Impella pump has been on the market for decades, there has never been a randomized controlled trial proving its benefit. The pump also comes with grave risks, puncturing ventricles or interfering with other heart devices if not properly inserted. Abiomed has been admonished by the Food and Drug Administration for not disclosing these risks to the agency as required under the law. Despite the safety risks and the lack of a randomized trial, the Impella has been widely adopted by interventional cardiologists, becoming a moneymaker for the device maker.
  • Several cardiologists STAT spoke with described Sunday’s results as a “striking” win for a patient population that has few treatment options proven to save lives.
• and
  • “Novo Nordisk’s Wegovy improved symptoms and physical function in patients who had obesity, diabetes, and a common type of heart failure, boosting Novo’s attempt to get the popular drug approved for yet another usage beyond weight loss.
  • “The study, being presented here on Saturday at the American College of Cardiology conference and published in the New England Journal of Medicine, reports results from the second large trial Novo has conducted on Wegovy in heart failure with preserved ejection fraction, or HFpEF. The first trial, which showed positive results last year, was in patients who had obesity and HFpEF, but not diabetes.
  • “Novo said it submitted the results of these two trials to regulators earlier this year and is seeking approval for a new indication in HFpEF. Wegovy just last month got FDA clearancefor its first usage besides weight loss — preventing cardiovascular complications in people with heart disease.
  • “Wegovy is part of a booming class of diabetes and obesity treatments called GLP-1 drugs that deliver substantial amounts of weight loss, but they’re costly and have been slow to gain widespread insurance coverage. Getting additional indications beyond weight loss could boost drugmakers’ arguments that the drugs are worth their cost and help streamline coverage.”

• The Wall Street Journal lets us know about “the calming power of rituals. Don’t just tell yourself to calm down: Adopting a routine for stressful moments—as many top athletes and performers do—can measurably reduce your agitation.
  • “A study by researchers at the University of Toronto showed exactly how this works. They taught subjects a physical ritual, then had them complete difficult button-pressing tests designed to induce errors, while monitoring their brain activity. The researchers were able to measure that an electrical response known as error-related negativity, or ERN, was reduced after subjects performed their rituals. In other words, participants were less focused on their mistakes, and that helped them stay closer to the moderate level of arousal ideal for performance under the Yerkes-Dodson law.
  • “No ritual has the power to make rock stars or savants out of us. We still have to contend with the realities of aptitude and proficiency and the discipline of daily practice. But rituals can give us a way to manage our nerves, dial into the skills we’ve worked so hard to achieve and give us that elusive something more that allows us to step into the spotlight and shine.”

From the U.S. healthcare business front,

• The Wall Street Journal reports
  • “For years now, there has been immense excitement for liquid biopsies—blood tests that can detect cancer early. Eventually, tests like the Galleri developed by Grail could revolutionize the practice of medicine by allowing patients to catch and treat the disease early.
  • “When it comes to colon cancer, though—the second biggest cause of cancer deaths behind lung cancer—blood-based tests have proved disappointing. The latest setback came last week, after privately held Freenome announced top-line results from a clinical study for the early detection of colon cancer among average-risk adults. The results failed to impress investors.  * * *
  • “The key reason Freenome’s results released last week didn’t excite investors is that they indicated the test wasn’t very good at catching precancer signs, which is the main thing doctors are looking for with early screenings. While the clinical study reported an overall 79.2% sensitivity in detecting colorectal cancer, it reported a sensitivity of 12.5% for detecting advanced adenomas, or precancerous polyps. That is far below the 42% sensitivity achieved by Cologuard [, a stool sample test.]”

• Healthcare IT News discusses Rush Memorial’s virtual intensive care unit.
  • “The virtual ICU has enabled Rush Memorial surgeons to feel comfortable performing more surgeries, knowing there is the clinical expertise to care for those patients in recovery in the ICU.
  • “If you are considering implementing a technology like this to provide needed coverage in your hospital, I highly recommend it,” Tressler advised. “Just be sure you are finding a vendor that has done it before, that has the experience and expertise to help you set it up appropriately, as well as the flexibility to work with your existing workflows.”

• Per Fierce Healthcare,
  • “Health insurers are gearing up to release their first-quarter results over the next several weeks, and a new analysis from Fitch Ratings finds that ongoing concern about utilization in Medicare Advantage (MA) has made for a cloudy outlook.
  • “The analysts wrote in the insurance dashboard report that payers with a significant presence in the MA space faced elevated medical loss ratios last year amid a spike in care utilization. Others, meanwhile, saw their MLRs decline last year, according to the report.
  • “The significant increase in 4Q23 senior market utilization reported by some companies creates significant uncertainty around profitability for the sector in 2024,” the analysts wrote.
  • “Despite the uncertainty, analysts at Fitch said earlier this year that the spike in utilization would likely be credit-neutral for the industry. In the dashboard report, the authors note that operating earnings before interest, taxes, depreciation and amortization was about 6.8% last year across the seven largest publicly traded insurers.”
  • “That’s a slight decrease from 7% in 2022, according to the report. These seven payers account for about 70% of membership in the U.S., according to the report.”

• McKinsey & Co. explains how price transparency could affect U.S. healthcare markets.
  • “This article puts price transparency rules in context and explores their implications, including:
    • “the existence of price dispersion in US healthcare that is not explained by differences in quality of care
    • “how price transparency rules address some market inefficiencies driving this price dispersion but leave others unresolved
    • “that patients—if given proper incentives and information—would be interested in shopping for care that amounts to 20 to 25 percent of US healthcare claims spend, potentially unlocking gains in affordability for consumers
    • “the potential for price transparency rules, together with other innovations, such as advances in technology and analytics, to empower patients to shop for care more than ever, helping offset growth in healthcare costs
    • “implications for healthcare industry stakeholders, potential shifts in industry profit pools, and first-mover advantages for organizations that capitalize on this opportunity to improve healthcare for US consumers.”