Weekend update

David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, U.S. Healthcare–

From Washington, DC

  • Forbes reports,
    • “Markets are watching as twin deadlines for a government shutdown are approaching on March 1 and March 8. The first deadline impacts four of twelve appropriations areas for the U.S. government, the second the remaining eight.
    • “However, it’s possible that budgets pass in the coming days that avert a shutdown. If not, another continuing resolution, as has avoided previous potential shutdowns, appears likely. Continuing resolutions give lawmakers more time to pass a new budget by essentially rolling forward prior funding measures.
    • “Currently event forecasting site Kalshi, gives an approximately 20% chance of a shutdown by March 4, and estimates that any shutdown before July might last only days. As such, expectations are that a shutdown will likely be avoided and were a shutdown to occur, it would be brief.
    • “However, if no government budget is passed before April, then the Fiscal Responsibility Act may come into effect that could have considerable impact on government spending. That would likely impact economic growth and the trajectory of government debt.”
  • MedTech Dive tells us,
    • The current system for monitoring and recalling medical devices is failing patients, physicians wrote in the journal Health Affairs on Thursday.
    • With the Government Accountability Office (GAO) reviewing device recalls, the physicians looked at the current process to generate suggestions for improving medical device safety in the U.S.
    • The physicians advised the GAO to propose ways to clear barriers to the implementation of unique device identifiers (UDIs) and assess how the FDA can better use the National Evaluation System for Health Technology.

From the public health and medical research front,

  • The Centers for Disease Control updated its Respiratory Illness Activity Levels website on February 23.
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare is elevated across many areas of the country. This week, 27 jurisdictions experienced high or very high activity. This number remains stable compared to last week.
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.
    • “Influenza test positivity decreased slightly nationally but is increasing in the Northeastern, Mid-Atlantic, and Central parts of the country. COVID-19 and RSV test positivity decreased compared to the previous week.
    • “Nationally, COVID-19 wastewater viral activity levels, which reflect both symptomatic and asymptomatic infections, remain at high levels, particularly in the South, but are trending downward in other areas.”
  • The New York Times reports,
    • “A drug that has been used for decades to treat allergic asthma and hives significantly reduced the risk of life-threatening reactions in children with severe food allergies who were exposed to trace amounts of peanuts, cashews, milk and eggs, researchers reported on Sunday.
    • “The drug, Xolair, has already been approved by the Food and Drug Administration for adults and children over age 1 with food allergies. It is the first treatment that drastically cuts the risk of serious reactions — like anaphylaxis, a life-threatening allergic reaction that causes the body to go into shock — after accidental exposures to various food allergens.
    • “The results of the researchers’ study, presented at the annual conference of the American Academy of Allergy, Asthma and Immunology in Washington, were published in The New England Journal of Medicine.
    • “For a certain population of food allergy patients, this medication will be life-changing,” said Dr. Robert A. Wood, the paper’s first author and director of the Eudowood Division of Pediatric Allergy, Immunology and Rheumatology at Johns Hopkins Children’s Center.”
  • NPR Shots points out,
    • “E-bike injuries have surged, sending thousands of Americans to hospitals in recent years, new research shows. 
    • “Electronic bicycle accidents were particularly hard on riders’ heads, especially the majority of those injured who didn’t wear helmets. 
    • “Helmet use declined by almost 6 percent each year between 2017 and 2022, while the number of e-bike riders with head trauma seeking hospital care shot up 49 fold to nearly 8,000 in 2022, according to research published in JAMA Surgery on Wednesday.
    • “It’s a really significant public health problem,” said Dr. Laura Goodman, a pediatric surgeon and trauma medical director of the Children’s Hospital of Orange County, who was not involved with the study.”
  • The Washington Post explains “How to make your hearing aids more effective and less frustrating. In one study, only 29 percent of those with hearing loss used hearing aids.” 
  • Fortune Well informs us,
    • “A large study in China tracked middle-aged and older adults for 20 years, using regular brain scans, spinal taps and other tests.
    • “Compared to those who remained cognitively healthy, people who eventually developed the mind-robbing disease had higher levels of an Alzheimer’s-linked protein in their spinal fluid 18 years prior to diagnosis, researchers reported Wednesday. Then every few years afterward, the study detected another so-called biomarker of brewing trouble.
    • “Scientists don’t know exactly how Alzheimer’s forms. One early hallmark is that sticky protein called beta-amyloid, which over time builds up into brain-clogging plaques. Amyloid alone isn’t enough to damage memory — plenty of healthy people’s brains harbor a lot of plaque. An abnormal tau protein that forms neuron-killing tangles is one of several co-conspirators.
    • “The new research, published in the New England Journal of Medicine, offers a timeline for how those abnormalities pile up.
    • :The study’s importance “cannot be overstated,” said Dr. Richard Mayeux, an Alzheimer’s specialist at Columbia University who wasn’t involved in the research.
    • [However, t]he findings have no practical implications yet.”

From the U.S. healthcare business front,

  • Forbes offers very useful rankings of the largest health insurance companies by U.S. overall, individual coverage, group coverage, and by individual U.S. state.
  • Per BioPharma Dive,
    • “BioMarin Pharmaceutical is struggling to sell the first marketed gene therapy for the most common form of hemophilia, announcing on Thursday minimal revenue from the treatment, called Roctavian.
    • “In its latest earnings report, BioMarin said Roctavian generated $2.7 million in sales during the fourth quarter and $3.5 million in all of 2023, as three total patients — two in Germany and one in the U.S. — were treated last year. New CEO Alex Hardy told analysts the company is seeing progress in “market access,” but is “very mindful of the return on investment” with Roctavian.
    • “Roctavian is one of two important new products for BioMarin, which is reviewing its business under new management and deciding what research to continue supporting. The other, a drug for dwarfism called Voxzogo, is surpassing expectations. Sales totaled $146 million last quarter, more than double the previous period.”
  • CNBC reports on how “new sickle cell gene therapies are a breakthrough, but solving how to pay their high prices is a struggle.”
    • “[Michael] Goodwin [, a 36 year old man with sickle cell disease,] worries about the cost. Vertex Pharmaceuticals’ gene therapy Casgevy lists for $2.2 million, while Bluebird Bio’s treatment Lyfgenia lists for $3.1 million.
    • “I do have insurance, but … I already have medical bills,” he said.
    • “Goodwin’s hesitancy to pursue treatment is no surprise to Dr. Julie Kanter, director of the Adult Sickle Clinic at the University of Alabama at Birmingham.
    • “My guess is even if we opened the gates today to everybody getting this therapy, at most only 10% of those individuals affected by sickle cell would want this therapy,” said Kanter, who also serves as the president of the National Alliance of Sickle Cell Centers. “And even that would be too much for us to manage right this second.”
    • “More than 100,000 Americans have sickle cell disease, according to Centers for Disease Control and Prevention estimates, and between 50% and 60% of them covered are covered by the federal and state insurance program Medicaid.
    • “Kanter said it will take time to ramp up capacity and to set up facilities across the country to treat patients at scale.
    • “We really hope that having the National Alliance of Sickle Cell Centers will allow us to strengthen our centers to generally care better for people living with this disease, which we haven’t been able to do before because the cost is a problem,” she said.