In the News: FDA Approves 2nd Oral GLP-1, Another Vaccine Reduces Risk of Dementia, and Costs of Vaccine-Preventable Diseases

Friday’s blog post (Position Paper: Expediting Drug Approval for Pediatric IBD) has been updated to reflect the recent approval of Stelara (ustekinumab) for the treatment of pediatric patients 2 years and older with moderately to severely active Crohn’s disease. Here’s a link: Johnson & Johnson (JNJ) Gains FDA Approval for Pediatric Crohn’s Disease Treatment. Thanks to Matthew Kowalik, MD, the Director (Acting) of Division of Gastroenterology for FDA/CDER/OND/OII, for bringing this to my attention.


Congratulatons to Rachel Rosen who is the pediatric gastroenterology recipient of  this year’s AGA Institute Council Section Research Mentor Award.


B Lovelace Jr, NBC News, 4/1/26: FDA approves weight loss pill from Eli Lilly

“The daily pill, called Foundayo [orforglipron], follows the approval of Novo Nordisk’s Wegovy pill in recent months. The lowest dose is expected to cost $149 a month for people paying out of pocket…Foundayo will be offered in six doses, with patients typically starting on the lowest dose and working their way up to reduce side effects. It can be taken at any time of day without meal restrictions — unlike the Wegovy pill, which must be taken on an empty stomach each morning…Phase 3 clinical trial data found that Foundayo helped people lose 12.4% of their weight, on average, at its highest dose after 72 weeks — similar to the Wegovy pill but less than injectable versions of Wegovy and Zepbound.”

The FDA has asked Lilly for more safety data. NBC News 4/14/26: FDA asks Lilly for more safety data on weight loss pill Foundayo

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Also, there was a recent article in Nature (Genetic predictors of GLP1 receptor agonist weight loss and side effects) showing that a genetic variant can predict whether GLP-1 response is more robust. Explainer: Why obesity drugs work better for some people: these genes hold clues

AS Bukhbinder et al. Neurology 2026; 106 (8) e214782. Open Access! Risk of Alzheimer Dementia After High-Dose vs Standard-Dose Influenza Vaccination

This was a retrospective study comparing the high dose influenza vaccine (H-IIV) compared to the standard dose (S-IIV) in 65+ patients. The H-IIV group included 120,775 unique participants (185,183 person-trials; mean age 74.4 years, SD 5.5; 57.3% female), and the S-IIV group included 44,022 participants (53,918 person-trials; mean age 73.0, SD 6.1; 56.4% female).

Key findings:

  • H-IIV was associated with significantly lower AD risk during months 1–25 postvaccination (minimum NNT = 185.2 at 25 months), with a stronger effect among women.

Also, infectious disease outbreaks are expensive. M Baker, American Action Forum 4/3/26. Vaccines Protect More Than Health – They Protect Economic Capacity

“Routine childhood immunizations in the United States from 1994 through 2023 are estimated to have prevented roughly 508 million illnesses, 32 million hospitalizations, and more than 1 million deaths. Those gains translated into approximately $540 billion in direct medical cost savings and nearly $2.7 trillion in total societal savings. Put simply, every $1 spent on childhood immunizations generated about $11 in savings…Adult vaccination also produces meaningful economic gains, particularly through reduced absenteeism, less presenteeism, and better labor-market continuity. Evidence suggests that adult immunization programs can return up to 19 times their initial investment.”

“In South Carolina, a 2025–2026 outbreak with 993 cases generated an estimated $35.5 million in costs, compared with $66,193 to vaccinate the same number of children through VFC. Those costs are only growing – the outbreak in South Carolina has not yet abated.”

Rising ER Costs & Changes in Billling Codes

USAToday: ‘Really astonishing’: Average cost of hospital ER visit surges 176% in a decade, report says

An excerpt:

The average emergency room visit cost $1,389 in 2017, up 176% over the decade. That is the cost of entry for emergency care; it does not include extra charges such as blood tests, IVs, drugs or other treatments…

In 2008, 17% of hospital visits were charged the most expensive code. That surged to 27% of visits in 2017, the report said. The average price for the most expensive code more than doubled from $754 in 2008 to $1,895 in 2017.

Hospitals also increased billings for the second most expensive code, but they billed the three least expensive codes less often compared to a decade ago.

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My First Take: It is Hard to Save $$$ at a Rolls-Royce Dealership

A recent article looked at a crucial issue –trying to deliver “best care at lower cost” (Inflamm Bowel Dis 2014; 20: 946-51).  “The goal of this report is to answer the primary question: What are implementable strategies and exploratory considerations for cost-efficient anti-TNF use while maintaining the highest quality of IBD care?”

The strategies that are discussed include the following:

  • Reduce costs of avoidable dose intensification of class switching by eliminating episodic anti-TNF use and improving patient education
  • Reduce over-utilization costs by accurately determining indication for escalating anti-TNF use
  • Reduce nondrug infliximab costs through shortened infusion times after initial safety is clearly established

Exploratory considerations:

  • Self-injectable anti-TNFs
  • Combination therapy
  • Monitoring anti-TNF drug levels and autoantibodies
  • Assessing mucosal healing as a clinical endpoint

The authors discuss both the exploratory issues and the strategies.  Some of each could easily increase costs, at least in the short-term, rather than reduce them.  The authors also make note of the development of an infliximab biosimilar (Inflecta) which could be approved in U.S. by 2015.

While the review article is a good read, in my opinion the authors fail to address in a meaningful way the larger context.  The costs for hospital-based care are enormous; pediatric hospitals are like Rolls-Royce dealerships; and by the way, if you have to ask how much it costs, you probably cannot afford it.  With regard to charges/costs, there is little transparency, high variability, and little accountability.  Understanding health care costs and trying to get a good deal is much harder than buying a car.

For IBD care, as an example, the authors make note of the cost of infliximab at one pediatric tertiary care center.  At this institution, “77% of the total health care cost for each infusion encounter” was for non-drug costs.  Given how expensive the drug cost is, the expense for an infusion is very high, but probably similar to many other pediatric hospitals.

If one is interested in reducing the costs of infliximab and other infusions, the first practical step would be to consider infusion outside of a hospital-based setting, such as an infusion center.  In such a setting, the patient safety would still be excellent but the costs would be less.

In Atlanta, there have been some high-profile hospital acquisitions that have increased health care costs (When doctors sell out, hospitals cash in | www.myajc.com).  In many circumstances, when a hospital acquires a physician practice, infusion center, or endoscopy center, the charges and reimbursement increase despite no change in clinical care.  In this way and many others, the current system promotes cost-inefficient care.

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