Monday Roundup

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, FDA, Mental health care, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The New York Times reports,
    • “After days of warnings, [Rep. Matt] Gaetz [(R FL)] rose Monday evening [on the floor of the House of Representatives] to bring up a resolution declaring the speakership vacant. That started a process that would force a vote within days on whether to keep Mr. McCarthy in his post. * * *
    • “Under House rules, Mr. McCarthy and his leadership team will need to address the motion within two legislative days — though they could do so sooner.”
  • Roll Call adds,
    • “The Senate will adjourn earlier than planned this week, with no session on Thursday, to allow members to travel to California and pay their respects to the late Sen. Dianne Feinstein. * * *
    • “On Sunday, California Gov. Gavin Newsom appointed Laphonza Butler to fill the remainder of Feinstein’s term. Butler recently led the abortion rights campaign group EMILY’s List and spent 20 years as president of SEIU Local 2015, a home care workers union in California.
    • “Butler will serve until a replacement is elected in a still-unscheduled special election. Three House Democrats — Barbara Lee, Katie Porter and Adam B. Schiff — are running in the March primary for the full, six-year term and can also run in the special election.
    • “Butler is scheduled to be sworn in by Harris on Tuesday. She will become the first openly gay Black woman to serve in the Senate.”
  • Last Thursday, U.S. District Judge John Bates vacated a Trump-era Affordable Care Act rule permitting health plans, including FEHB plans, to use copay assistance accumulators. These accumulators prevent manufacturer assistance used to pay cost-sharing for expensive drugs from counting towards out-of-pocket maximums. While that outcome seems reasonable to the FEHBlog, Judge Bates takes the opposite view in his opinion. The federal government, which is the defendant in the case, has the right to appeal this final judgment.
  • The Institute for Clinical and Economic Research published a “Special Report on Eliquis and Xarelto Submitted to CMS as Part of Public Comment Process on Medicare Drug Price Negotiations.” The report “evaluate[es] the evidence on apixaban (Eliquis®, Bristol-Myers Squibb) and rivaroxaban (Xarelto®, Bayer) for the treatment of nonvalvular atrial fibrillation (NVAF).”
  • BioPharma Dive identifies five Food and Drug Administration to watch for in the fourth quarter of 2023. “By the end of the year, the regulator will decide on new genetic treatments for sickle cell, expanded use of Alnylam’s Onpattro and an inflammatory disease drug from Pfizer.”

From the public health front,

  • MedPage Today informs us
    • “Maternal COVID vaccination in pregnancy protected young infants against Omicron-associated hospitalization, but few women actually receive the vaccine during pregnancy, according to new data from the CDC.
    • “At least one maternal vaccine dose had an effectiveness of 54% (95% CI 32-68) against COVID-related hospitalization among infants younger than 3 months of age, and an effectiveness of 35% (95% CI 15-51) for infants younger than 6 months, reported researchers led by Regina Simeone, Ph.D., of CDC’s National Center for Immunization and Respiratory Diseases in Atlanta, in the Morbidity and Mortality Weekly Report. * * *
    • “Looking at the COVID shot specifically, women were nine times more likely to receive a bivalent booster if a provider recommended it (63.2% vs 6.8% when a provider did not).”
  • The American Medical Association offers “What doctors wish patients knew about managing anxiety disorders.”
  • STAT News points out,
    • “In a guidance document published Monday in the Federal Register, the CDC is seeking input on its proposal that health providers offer gay and bisexual men who have sex with men, as well as transgendered women, access to a common antibiotic, doxycycline, that they could take after having had unprotected sex to lower their risk of acquiring chlamydia, gonorrhea, or syphilis. Doxycycline is in the tetracycline family of antibiotics.
    • “Studies have show the so-called “doxy PEP” regime — a single, 200-milligram dose taken no later than 72 hours after unprotected sex — can reduce acquisition of chlamydia and syphilis by nearly 80%, and gonorrhea by about 50%. PEP is short for post-exposure prophylaxis.
    • “Doxy PEP is moving STI prevention efforts into the 21st century,” Jonathan Mermin, director of CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention, said in a statement. “We need game-changing innovations to turn the STI epidemic around, and this is a major step in the right direction.”

From the awards front,

  • The Wall Street Journal reports
    • “Katalin Karikó and Drew Weissman won the Nobel Prize in medicine on Monday for an idea that pushed them to the fringes of the scientific establishment before it saved millions of lives during the pandemic. 
    • “Karikó, a molecular biologist, and Weissman, an immunologist, realized during a chance encounter at a University of Pennsylvania a photocopy machine in the 1990s that they could combine their work exploring messenger RNA’s potential in drugs or vaccines. 
    • “Their collaboration was met with skepticism by their colleagues and indifference in the scientific community. Karikó struggled to secure funding for her work. Penn demoted her and sent her to work in an office on the outskirts of campus. 
    • “People wondered, ‘What the hell is wrong with her,’ there must be some reason she’s not on the faculty,” Karikó has said.
    • “Years later, as drugmakers raced to develop vaccines against COVID-19, it was mRNA technology that powered widely used shots from Pfizer–BioNTech and Moderna. The Nobel committee credited Karikó’s and Weissman’s work with saving millions of lives.
    • “The laureates contributed to the unprecedented rate of vaccine development during one of the greatest threats to human health in modern times,” the committee said in awarding Karikó, 68, and Weissman, 64, the annual prize in physiology or medicine. Karikó is the 13th woman among 227 people to win the prize.”
    • Bravo.
  • Fierce Healthcare announced its Fierce 50.
    • “The Fierce 50 goes beyond surface-level accolades to delve deep into the monumental impact 50 exceptional individuals and organizations have on the lives of patients. It shines a spotlight on the visionaries and trailblazers who have pioneered groundbreaking therapies, overhauled patient care models, and spearheaded innovative approaches to address the most pressing challenges in biopharma and healthcare.”

From the U.S. healthcare business front,

  • Beckers Hospital CFO Report tells us,
    • “Hospital margins are moving in the right direction, as the median year-to-date operating margin improved in August to 1.1 percent, according to Kaufman Hall. 
    • “August’s median of 1.1 percent marked an upswing from the 0.9 percent median margin recorded in July, according to Kaufman Hall’s latest “National Hospital Flash Report” — based on data from more than 1,300 hospitals.
    • “Increased revenue offset hospitals’ increased supply and drug expenses in August. Decreased reliance on contract labor helped labor expenses decline on a volume-adjusted basis, while average lengths of stay also fell, by 4 percent month over month.”