Weekend Update

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, OPM, Patient safety, U.S. Healthcare–

From Washington, DC

  • The FEHBlog noticed the following noteworthy hearing scheduled for Wednesday, March 25:
    • House Appropriations Subcommittee on Financial Services and General Government
    • 10:00 AM Local Time | 2359 Rayburn House Office Building, Washington, D.C.
    • Hearing: Oversight Hearing – U.S. Office of Personnel Management
    • Witnesses: The Honorable Scott Kupor.
    • Meeting Details
  • Per a Federal Trade Commission news release,
    • “Today, Federal Trade Commission Chairman Andrew N. Ferguson directed FTC staff to form a Healthcare Task Force that will engage in a coordinated, integrated approach to healthcare enforcement and advocacy to protect American patients, healthcare workers, and taxpayers.
    • “In a memorandum, Chairman Ferguson directed the FTC’s Bureaus of Competition, Consumer Protection and Economics, as well as the Office of Policy Planning and Office of Technology to form the Healthcare Task Force.
    • “The Healthcare Task Force will:
      • “Lead targeted enforcement and advocacy initiatives focused on key priorities;
      • “Devise coordinated agencywide strategies on investigations;
      • “Take a proactive and strategic approach to identifying amicus and statement of interest opportunities; and
      • “Identify emerging issues and new priority areas for enforcement and advocacy.”
  • The American Hospital Association News tells us,
    • “The White House today [March 20] released its national policy framework on artificial intelligence. The framework includes several recommendations for Congress, including establishing regulatory sandboxes to foster AI application development, providing resources to make federal data accessible to industry, and a proposal to not create new federal rulemaking bodies to regulate AI. It urges Congress to support the development and deployment of sector-specific AI applications through existing regulatory mechanisms.  
    • “Additionally, the framework includes workforce-specific recommendations for Congress, such as expanding federal efforts to study trends in task realignment driven by AI to inform future workforce policies. Finally, the framework also calls for Congress to establish policies to preempt state laws that impose undue burden but not preempt otherwise lawful state regulations related to child safety, zoning for data centers and state government procurement of AI.”

From the Food and Drug Administration front,

  • MSN informs us,
    • “Organic spinach, both bulk and cut, has been recalled nationwide after testing found listeria.
    • “Sno Pac Foods recalled Sno Pac Organic Frozen Cut Spinach in 10-ounce bags and Del Mar Bulk Organic Frozen Spinach in 35-pound boxes the day after Sno Pac spinach in HelloFresh meals triggered a public health alert.”
  • Health Day reports,
    • “A long-debated plan to block teens from using tanning beds nationwide will not move forward.
    • ‘The U.S. Food and Drug Administration (FDA) said earlier this week it is withdrawing a proposed rule that would have banned anyone under age 18 from using tanning beds.
    • “The rule, first proposed in 2015, would have also required adults to sign a waiver acknowledging risks like skin cancer and severe burns before using tanning devices.
    • “Without a federal rule, regulations will continue to vary by state. Some states, including California, Delaware, Illinois, Kansas and Minnesota as well as Washington, D.C., already bar minors from using tanning beds.
    • “Other states allow teens to use them with the consent of a parent.
    • “The FDA stressed that the “withdrawal of the proposed restrictions does not mean that exposure to UV radiation does not cause skin cancer.”

From the public health and medical / Rx research front,

  • Health Day reports,
    • “High blood pressure is taking a growing toll on younger women, a new study warns.
    • “Researchers say deaths from heart disease linked to hypertension are rising among women ages 25 to 44.
    • ‘The rate has more than quadrupled over the past two decades — from about one to nearly five per 100-thousand women – according to their analysis.
    • “What’s behind the increase? One author points to an  underestimated cardiovascular risk, delayed diagnosis and missed chances for early treatment.
    • ‘She says, “Even though hypertension is more prevalent in older populations, it’s something that we need to be vigilant about in younger populations, as well.”
  • MedPage Today suggests, “To Limit Antibiotic Overprescribing, Take a Page from the Opioid Epidemic — Both drugs are dangerous when misused.
    • “The following strategies may help reduce inappropriate prescribing:
      • “Prescription drug monitoring programs. Statewide programs to monitor opioid prescriptions are credited with curbing prescribing rates. While these programs are intended to provide clinicians with patients’ medication histories, they can also be used to identify outlier over-prescribers, and artificial intelligence can be used to quickly analyze large prescribing datasets and recognize patterns of overuse.
      • “Prescriber education and feedback. Institutional programs focused on individual prescriber education and feedback can reduce both opioid and antibiotic prescribing. Since 2019, the Centers for Medicare & Medicaid Services has required hospitals to implement inpatient antimicrobial stewardship programs, which monitor antibiotic prescription and promote appropriate use. Similar requirements do not yet exist for outpatient settings, where most antibiotic prescribing occurs, and expanding outpatient stewardship efforts could substantially reduce overuse.
      • “Published treatment guidelines. In 2016, the CDC released evidence-based guidelines for the use of opioids for chronic pain, which helped reduce opioid use by encouraging lower doses, shorter durations, and non-opioid alternatives. While guidelines for antibiotic prescribing do exist, more definitive recommendations for avoiding antibiotics in patients with a low likelihood of bacterial infection could help promote more judicious prescribing.
      • “Public education campaigns. Campaigns to educate the public on the harms of antibiotic misuse would reduce the demand for these medicines, just as growing awareness of the dangers of opioids has prompted some patients to ask for alternative options for pain relief.”
  • The New York Times lets us know four things opthamologists wish you knew about your eyes.
    • “Your eyes can get sunburned.”
    • “Contacts should not be worn while swimming or sleeping.”
    • “Staring at your screen can cause dry eyes.”
    • “An eye exam can reveal a wide range of diseases.”
  • Health Day notes,
    • “Got something important you don’t dare forget — like taking your heart medication, turning off the stove or a big date? 
    • “Here’s some friendly advice from Carrie Cuttler, a researcher at Washington State University in Pullman.
      • “You probably don’t want to be high at the time you need to remember to do it,” said Cuttler, an associate professor of psychology and co-author of a new study looking at what cannabis does to your memory.
      • “In a study of 120 regular cannabis users, she and her colleague Ryan McLaughlin found that smoking weed disrupted multiple memory systems at the same time. 
      • “In fact, they reported, THC, the chemical in cannabis that makes you high, may do even more than make you a tad forgetful. It can even create new memories — of things that never happened.”
    • “The findings were recently published in the Journal of Psychopharmacology.
    • “The research suggests that cannabis affects not only simple recall — like remembering a list of words — but kinds of memories people rely on to get through the day.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “Providence is exploring a potential sale of its health plan, citing the higher spending that’s swamping insurers.
    • “The news disclosed on Thursday [March 19] comes as the Catholic nonprofit system continues to pursue a financial turnaround plan that’s included layoffs and hospital sales.
    • “Providence declined to comment on potential acquirers or timing of a deal, and said it will provide updates as decisions are made.”
    • “Providence said its decision to consider a sale of Providence Health Plan isn’t due to the plan’s quality, but its struggle as a smaller regional insurer to overcome challenges like rising costs and technology investments that are easier for its larger peers.
    • “PHP covers hundreds of thousands of members, mostly in the Pacific Northwest, across employer, commercial Medicare, Medicare Advantage, managed Medicaid and Affordable Care Act plans.”
  • BioPharma Dive relates
    • “Earendil Labs, a high-powered startup with a presence in China and the U.S., has secured $787 million to advance a sprawling pipeline of biologic medicines for autoimmune conditions and cancer. 
    • “The hefty funding announced by the biotechnology company on Friday included more than half a dozen investors, among them venture firms Dimension and Luminous Ventures and the French pharmaceutical giant Sanofi. That bankroll “allows us to operate at a fundamentally different scale,” enabling the company to advance several programs towards clinical testing while building an “R&D organization designed for long-term impact,” founder and CEO Jian Peng said in a statement.”
    • “The company is using artificial intelligence to develop next-generation biologics for several different diseases, from asthma and eczema to colorectal cancer. Earendil claims its technology has produced more than 40 programs overall, and on its website lists 19 in its pipeline. One, for inflammatory bowel disease, is ready for Phase 2 development, the company said Friday.”

Notable Death

  • The Washington Post reports,
    • “J. Michael Bishop, a microbiologist who shared a Nobel Prize in 1989 for research that illuminated the genetic roots of cancer, and who later served as chancellor of the University of California at San Francisco, died March 20 at a hospital in San Francisco. He was 90.
    • ‘The cause was pneumonia, said his son Eliot Bishop.”
  • RIP

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