Using electronic medical record data, the study’s authors reviewed more than 5 million births at over 40 hospitals across all 50 states between 2017 and 2024. The number of infants who did not receive the shot at birth rose from 2.92% in 2017 to 5.18% in 2024, according to the report…
Since 1961, the AAP has recommended that a single shot of vitamin K be given at birth to protect against bleeding. All babies are born deficient in vitamin K.”
My take: Avoidance of Vitamin K in the newborn period indicates a mistrust of the medical system as well as desire for a more “natural” birth experience. However, this increases the chance than an infant will have permanent severe brain damage. When parents refuse Vitamin K, they are playing Russian roulette with their newborn’s life.
Background: “Recent studies demonstrate only 11% of youth between 9 and 21 years of age in the United States (US) had documented lipid screening, and 30%-60% of youth with dyslipidemia may be missed by targeted screening alone (ie, risk factors) compared with ULS [universal lipid screening]. Identification of youth living with familial hypercholesterolemia (FH) has the added benefit of triggering reverse cascade screening of family members, which can further identify at risk youth and adults.”
“In 2024, the Family Heart Foundation (FHF) established the Leveraging Evidence and Data (LEAD) for Pediatric Cholesterol Screening Initiative…The focus was not on creating new screening guidelines, but on developing strategies that will lead to better implementation of the current NHLBI/AAP screening recommendations, and with the overall goal of reducing global ASCVD [atherosclerotic cardiovascular disease] burden.”
“In FH,untreated elevated levels of LDL-C in childhood significantly increase the risk for premature atherosclerotic cardiovascular disease (ASCVD), which is the leading cause of death both in the US and worldwide. However, early initiation of statin therapy for children living with FH reduces the ASCVD risk in adulthood.”
Key points:
“Three common barriers to pediatric ULS were identified.
First, many parents and caregivers are not aware of the current pediatric lipid screening guidelines.
Second, the major rationale for ULS in young children and adolescents—early identification of a treatable genetic condition—may not be clear to patients, families, and/or clinicians.
Third, the values and concerns of families may be dismissed by clinicians if there is a misunderstanding of the rationale for ULS
Practical ways to improve ULS:
Improve education of parents and clinicians that ULS can reduce the risk of premature death from the leading cause
Point-of-care testing
EHR prompts
Develop physician “FH champions”
The article notes that a survey in 2017 showed that many PCPs were unaware of the national guidelines. In addition, “few were comfortable prescribing a lipid-lowering therapy.”
Recommended PCP Screening Algorithm:
My take: It is unfortunate that this article, which has an aim to improve awareness for universal pediatric lipid screening (ULS), is not an open access article. Incentives to implement lipid screening could help — screening rates are quite low despite guidelines that were published 14 yrs ago.
Related blog posts:
The Case for Universal Cholesterol Screening During Childhood (2024) — An excellent summary of the need/rationale for ULS. Heterozygous FH (HeFH) is the second most common potentially fatal genetic disorder in humans, affecting 1 in 250-300 people.8…Homozygous FH (HoFH) [is] much rarer, occurring in 1:250 000-1:360 000 people.. Proof that screening can make a difference:
Treatment Outcomes in Children and Adolescents with Hypercholesterolemia In a 20-year follow-up study, Luirink et al studied a cohort of individuals with genetically confirmed HeFH who had initiated statin therapy in childhood. When compared with their HeFH parents who had not had the benefit of childhood therapy, statins virtually eliminated excess ASCVD risk in adulthood. At age 40, 26% of parents had experienced a cardiac event and 7% had died of ASCVD, whereas only 1% of the those treated as children had needed a vascular procedure (coronary artery stenting) and none had died.
With regard to incentives, a recent commentary (DM Cutler, RS Huckman. NEJM 2025; 2025;393:2177-2180. Has Corporatization Met Its Match? The Challenge of Making Money by Keeping People Healthy) notes that the U.S. health system has financial incentives that rewards care for individuals who are sick rather than keeping patients healthy. “The system focuses its resources primarily on treatment rather than prevention…The dearth of successful business models aimed at keeping people healthy highlights one of the central challenges of the growing corporatization of health care: how to make money producing health, not just health care. The path to doing so will require fundamental changes in the incentives for individuals and institutions and, potentially, broader structural change by policymakers to increase access to or financial support for basic preventive care.”
Disclaimer: This blog, gutsandgrowth, assumes no responsibility for any use or operation of any method, product, instruction, concept or idea contained in the material herein or for any injury or damage to persons or property (whether products liability, negligence or otherwise) resulting from such use or operation. These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician. Because of rapid advances in the medical sciences, the gutsandgrowth blog cautions that independent verification should be made of diagnosis and drug dosages. The reader is solely responsible for the conduct of any suggested test or procedure. This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition.
“The Food and Drug Administration on Monday approved a pill version of Wegovy…The Wegovy pill, as it’s called, is first oral version of a GLP-1 drug that has been brought to market for weight loss…
In November, Novo Nordisk reached a deal with the Trump administration to sell the lowest dose of the pill for $149 a month for people who pay out of pocket, in exchange for tariff relief…
Phase 3 clinical trial results published in the New England Journal of Medicine found that people who took the highest dose of the Wegovy pill lost 16.6% of their body weight, on average, after 64 weeks, compared with 2.2% weight loss in the placebo group…
The company expects that the Wegovy pill will be available widely in January.”
“This 3-paper Series reviews the evidence about the increase in ultra-processed foods in diets globally and highlights the association with many non-communicable diseases. This rise in ultra-processed foods is driven by powerful global corporations who employ sophisticated political tactics to protect and maximize profits. Education and relying on behavior change by individuals is insufficient. Deteriorating diets are an urgent public health threat that requires coordinated policies and advocacy to regulate and reduce ultra-processed foods and improve access to fresh and minimally processed foods. The Series provides a different vision for the food system with emphasis on local food producers, preserving cultural foods transitions and economic benefits for communities.”
In one of the papers, led by Dr. Monteiro, the authors identified 104 studies linking ultraprocessed foods to health conditions, including Type 2 diabetes, obesity, heart disease, kidney disease and Crohn’s disease…
The authors suggested that governments adopt policies, like taxes on sugary drinks and warning labels for certain ultraprocessed foods, especially those high in sugar, fat or salt. They also recommended restrictions on marketing ultraprocessed foods to children and reducing their use in school meals. The proposed policies are similar to those that have worked to reduce smoking rates…
Robert F. Kennedy Jr., the nation’s health secretary, and his “Make America Healthy Again” movement have drawn attention to the links between poor health and ultraprocessed foods. But so far, Mr. Kennedy has focused on reducing the use of artificial colors and certain food additives, efforts that Dr. Popkin said would do little to improve the healthfulness of the food supply. And this year, the Trump administration cut SNAP benefits and programs that funded schools and food banks to purchase foods from local farms.”
R Bissonnette et al. NEJM 2025; 393: 1784-1795. Oral Icotrokinra for Plaque Psoriasis
RS Stern. NEJM 2025; 303: 1854-1855. Oral Psoriasis Therapy — For Whom and at What Cost and Risk?
S Wharton et al. NEJM 2025; 303: 1796-1806. Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist for Obesity Treatment
In the ICONIC-LEAD study (Bissonnette et al), 684 adolescents and adults participated in a DBPC trial with an oral peptide, icotrokinra, which binds the IL-23 receptor. This medication is of interest as there are ongoing trials with it for inflammatory bowel disease. Other injectable medications targeting IL-23 are already approved for IBD.
Key Findings:
The associated editorial notes that this new therapy is likely to cost ~$70,000 per year. The cost of psoriasis care has increased more than 2000% since 1997. “Because of these high prices, rebates and discounts to pharmacy benefit managers that often guide formulary preferences are likely to govern clinician’s selection of immune-based oral and parenteral therapies for psoriasis.”
In the ATTAIN-1 Trial (Wharton et al), the authors share the results of an oral GLP-1 Receptor Agonist, Orforglipron, monotherapy for obesity.
My take: There are similar injectable alternatives to each of these medications for psoriasis, obesity and diabetes. The availability of oral medications could reduce one barrier to treatment. Cost barriers may preclude their use in many patients when they become available. In addition, long-term outcome data are still needed.
This invited commentary reviews the data for several diets that may improve weight loss and metabolic dysfunction-associated steatotic liver disease (MSALD).
Several points:
“Extremely restricted plant‐based diets may have deficiencies of vitamin D, calcium, and vitamin B12 which are nutrients found in animal products, and can be minimized by vitamin supplementation or increasing consumption of fish, mushrooms, egg yolk, cod liver oil, salmon, herring, and sole fish. VitaminB12 supplementation is recommended in plant‐based diets because this vitamin is primarily found in animal products”
Table 1 compares the structure of these diets and their advantages/drawbacks
“Low to moderate weight loss can be seen in the anti-inflammatory diet, plant-based diets, or Mediterranean diet. These diets are nutritionally complete. However, restrictive plant-based diet carries a risk of micronutrient deficiencies, which can be corrected with appropriate supplementation. These diets are effective in treating MASLD independent of weight loss due to their anti-inflammatory profile.”
“The ketogenic diet, certain carbohydrate-restricted diets, and intermittent fasting can lead to more weight loss but carry a higher risk of malnutrition. Children on these diets must be followed by nutritionists.”
My take: Each of the diets reviewed can help MASLD and obesity. Most patients pursuing dietary therapy would benefit from working with a nutritionist.
Related news: TEVA Press release, August 28, 2025: Generic liraglutide (need for daily injections) is now available.
Also, related patient advice from Federation of International Societies for Pediatric Gastroenterology, Hepatology, and Nutrition (FISPGAN) –outlines risk factors and prevention tips for metabolic dysfunction-associated steatotic liver disease (MASLD):
SWharton et al. N Engl J Med 2025;393:1077-1087. Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity
Methods: The participants were randomly assigned in a 2:1 ratio to receive oral semaglutide (25 mg) or placebo once daily, plus lifestyle interventions.
Key Findings:
In their discussion, the authors note that the reasons why “patients may prefer oral administration over the subcutaneous route are most often needle aversion and local skin reactions.7,8 In addition, unlike injectable agents, oral agents may not require a refrigerated chain of delivery and could widen the reach of obesity care in many regions of the world where a lack of refrigeration represents a barrier to access.”
In addition, the results were similar to the “STEP 1 (Semaglutide Treatment Effect in People with Obesity) trial of weekly subcutaneous semaglutide at a dose of 2.4 mg (12.4 percentage points more than that with placebo),16“
As with prior trials of semaglutide, “treatment was also associated with substantial reductions in cardiometabolic risk factors including BMI, waist circumference, and levels of glycated hemoglobin, fasting plasma glucose, fasting serum insulin, lipids (very-low-density lipoprotein and triglycerides), and C-reactive protein.”
My take: Effective oral therapy is a big advance for management of obesity. The entire field of pharmacology for obesity has seen remarkable advances in the past few years. For me, it is reminiscent of the proliferation of published studies for hepatitis C around 10 years ago.
Related article in same NEJM issue: J Rosenstock et al. N Engl J Med 2025;393:1065-1076. Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist, in Early Type 2 Diabetes
In the ACHIEVE-1 Trial: Key Findings (n=559 adults):
The associated editorial by DB Lowe (N Engl J Med 2025;393:1133-1134) notes that Orforglipron is a small molecule that manages to mimic the effects of glucagon-like peptide-1 (GLP-1) at the GLP-1 receptor. “The incretins, like many peptide hormones, are fairly small as proteins go — a few dozen amino acids long. But that makes them gigantic as compared with small-molecule drugs. Their molecular weights are at least 10 times as high as the 300 to 500 mass units that medicinal chemists have traditionally aimed for, and being peptides, they have generally undesirable properties as well. Many have short half-lives in the circulation, which can be a desirable feature for endogenous peptides but is nowhere near what is needed for the administration of a once-daily dose.”
There has been a lot of hype about the benefits of a high protein diet. In a recent substack article (8/31/25) , Eric Topol reviews the data on this (for adults).
“The pervasive call for higher protein intake stems from the assertion that people are not getting adequate amounts in their diet, namely the 0.8 g/kg/day recommend by the National Academy of Medicine and the World Health Organization….
Regarding the need to increase protein intake 2-3 fold per day, Stuart Phillips, a leading expert on protein, energy, and building muscle mass, who is a professor at McMaster University in Canada, said “It’s baloney. But there’s a generation, particularly young men, and now an increasing number of young women, who are absolutely brainwashed by what they hear online”…there are no data to support more than 1.6 g/kg/day of protein intake.
“What about the strong recommendation for high protein in older adults? In the 50+ group, as reviewed by ten Haaf and colleagues, the randomized trials show no benefit of high protein on top of resistance training compared with resistance training alone (the control group) for improved lean body mass” [in 12 trials]
“There are many observational studies that have raised the safety concerns for high-protein intake, particularly derived from animal protein, for increased risk of type 2 diabetes, cardiovascular disease, and higher all-cause mortality. A prospective study of ~44,000 women in Sweden followed for 15.7 years found an association of high-protein diet with heightened cardiovascular risk.”
A “high protein intake is dangerous for people with kidney disease, present in 1 of 7 adults, but 9 of 10 people with reduced kidney function are unaware of it.”
My take (borrowed from Dr. Topol): “The body of evidence about protein does not provide support [for] very high protein intake, certainly not in excess of 1.6 g/kg/day…there is no way to store protein in the body…Resistance training is the principal driver for building muscle mass and strength, not high protein intake.” While this article focuses on adults, the premise is similar in children; though, on a per kilogram basis, children need modestly higher amounts. (Reference: JL Hudson et al. Nutrients. 2021 May 5;13(5):1554. Dietary Protein Requirements in Children: Methods for Consideration)
It has been recognized for quite some time that physical exercise, while important for health, does NOT play a big role in weight loss (see: Challenging the Obesity Myths, NEJM 2013; 368: 446-54. “Physical education, as typically provided, has not been shown to reduce or prevent obesity”). This article and the associated commentary from NPR provide further evidence of this.
Methods: The authors examined energy expenditure and two measures of obesity (body fat percentage and body mass index, BMI) for 4,213 adults from 34 populations across six continents and a wide range of lifestyles and economies, including hunter-gatherer, pastoralist, farming, and industrialized populations
Key findings:
“Economic development was positively associated with greater body mass, BMI, and body fat, but also with greater total, basal, and activity energy expenditure. Absolute measures of TEE (total energy expenditure) and AEE (activity energy expenditure) are greater in more economically developed populations (Fig. 2), consistent with their larger body size. Body size–adjusted TEE decreased marginally with greater development”
“Estimated energy intake was greater in economically developed populations, and in populations with available data (n = 25), the percentage of ultraprocessed food in the diet was associated with body fat percentage, suggesting that dietary intake plays a far greater role than reduced energy expenditure in obesity related to economic development.”
Commentary from NPR:
“Back in the 1800s, obesity was almost nonexistent in the United States. Over the last century, it’s become common here and in other industrialized nations…One common explanation is that as societies have developed, they’ve also become more sedentary, and people have gotten less active….But in a major new study published in the journal PNAS, Pontzer and an international team of collaborators found that’s not the case…the total calories burned per day is really similar across these populations, even though the lifestyle and the activity levels are really different…it does mean we can’t outrun a bad diet. Pontzer says if we want to tackle obesity, the public health message should focus on changing what’s on our plates.”
My take: This article further supports the idea that a healthy diet is the crucial factor with regard to weight gain. However, numerous studies have shown that physical activity is important for good health, regardless of one’s weight.
A Porto et al. J Pediatr Gastroenterol Nutr. 2025;81:5–10. New international infant formulas in the United States: Understanding the Food and Drug Administration-enforcement discretion
Background: In February 2022, the United States experienced a significant infant formula shortage, due to a major product recall by the country’s largest infant formula manufacturer, compounded by global supply chain issues and import restrictions.1, 2 In response, the Food and Drug Administration (FDA) launched Operation Fly Formula in mid-2022, which allowed international infant formula manufacturers to market, import and distribute their formulas in the United States…Currently, a total of five companies, who produce 14 international formulas, have opted to work with the FDA in transitioning to the US market.5 Many of these international formulas are significantly cheaper than the domestic alternatives, which have contributed to their rising popularity.
Key points:
8 of 14 formulas are stage formulas with Stage 1 for 0-6 months, and Stage 2 for >6 months. “Stage 1 formulas tend to contain less iron, which may provide an insufficient amount of iron for infants >6 months.11 Also, infants <6 months should not consume Stage 2 formula since it does not contain carnitine, believed to be an essential nutrient in this age group.12“
Of the 14 formulas, all the labels were in English and contained all the FDA nutrient requirement
“Two of the imported formulas [Aptamil brands] contained less than 1 mg/100 calories of formula of iron, the minimum amount to be considered iron fortified by the FDA, and did include a label which highlighted that additional iron may be necessary”
“All the foreign formulas contained prebiotics… The FDA, however, reports that probiotics can be dangerous for preterm infants and put them at risk for potentially fatal infection caused by the bacteria or yeast contained in the probiotic.6 Therefore, pediatricians should be aware that international formulas should not be used for preterm infants.”
MIXING INSTRUCTIONS: “Eleven out of the fourteen international formulas use a different scoop to water ratio from what is typically standard of American formulas…coops from international formulas may also be a different size compared to their US counterparts. Given the variation in different mixing ratios and scoop sizes, there is a risk of formula being mixed incorrectly”
“Consider that the family may be purchasing from a 3rd party vendor and ask for the specific website that they are purchasing from. Formulas should not be purchased at 3rd party vendor websites due to them being unregulated, and safety concerns with improper shipping or storage”
“If the label is not in English, it is highly likely that the formula has been purchased through a 3rd party vendor. Recommend counseling on safety concerns as listed above. Many of the foreign infant formulas use different mixing ratios so it is important that parents read the label to confirm mixing ratios”
My take: The availability of FDA-approved international formulas has been helpful especially with recent shortages. This article makes several important points to assure their proper use, especially regarding mixing instructions and using Stage formulas for appropriate age.
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