Danish residents with elevated lipids and CVD risk factors who were taking statins for CVD prevention saw a 16% lower risk per unit time of incident IBD, the researchers found (AS Faye et al. J Intern Med 2025;298[6]:686-696. Statin use for primary prevention of cardiovascular disease reduces the risk of incident IBD: A population-based cohort study)…
The study was a population-based, prospective cohort design drawing on the Danish National Registries. Participants were over 40 years of age and had undergone low-density lipoprotein (LDL) measurement between 2008 and 2022…Each of 110,961 people who picked up statin prescriptions within six months of LDL measurement was matched to five others (n=554,805) not prescribed statins by age, sex, calendar year, and CVD risk factors…
The aHR of developing IBD for statin users versus nonusers was 0.84 (95% CI 0.72-0.97)…The five-year number needed to treat (NNT) with statins was 2,881 to prevent one additional IBD case…
In addition to lipid-lowering properties, statins have anti-inflammatory and immunomodulating actions.
My take: This study suggests that statins have an “off target” beneficial effect in reducing the risk of inflammatory bowel disease. However, it is possible that statin use is not directly beneficial but an epiphenomenon. For example, individuals taking statins may have modified their diet to lower their risk as well.
Background: “Lynch syndrome (LS) is a prevalent hereditary cancer syndrome affecting ~1 in 300 individuals, with an overall lifetime cancer risk as high as 80%. LS is caused by germline mutations in the DNA mismatch repair genes, leading to microsatellite instability (MSI) and accumulation of shared mutations. When these occur in coding regions, they generate frameshift peptides (FSPs). Nous-209 is a neoantigen-directed immunotherapy” against these FSPS. These are “the results from cohort 1 of a phase 1b/2 single-arm trial of Nous-209 for cancer interception in LS carriers (n = 45).”
Key findings:
Neoantigen-specific immune responses were observed after vaccination in 100% of evaluable participants (n = 37), with induction of potent T cell immunity
The immune response was durable and detectable at 1 year in 85% of participants
Both CD8+ and CD4+ T cells were induced, recognizing multiple FSPs
Peptide–human leukocyte antigen predictions allowed the identification of >100 immunogenic FSPs with demonstration of cytotoxic activity in vitro
Colorectal neoplasia burden observed at end-of-study colonoscopy inversely correlates with breadth of immune response. a, Number of participants who underwent screening colonoscopy at baseline and end of study (EoS; n = 43) who had no adenomas (adenomas absent), at least one adenoma (adenomas present) and advanced adenomas (advanced adenomas present) detected.b, Number of adenomas per trial participant at baseline and end of study; comparison of baseline versus EoS was performed using a two-tailed Mann–Whitney U-test; NS, not significant. c, Number of reactive pools measured at 6 months (n = 34 evaluable subjects) between the participants with and without adenomas. Data are shown as the mean ± s.e.m.
My take (borrowed in part from authors): “Overall, this clinical trial provides important proof-of-concept data of the safety and the robustness of induced immunogenicity of Nous-209 in LS carriers…and supporting its clinical development as a valuable intervention for cancer immune interception.” Vaccines have a long history in reducing cancer (for Hepatitis B, Cervical Cancer (due to HPV), Anal Cancer, Leukemia (by boosting immunity) and Others). Until recently, this has been by preventing viral infections that increase the risk of cancer. This is a new approach.
Related article: Blood test for colorectal cancer: A Mannucci et al. Gastroenterol 2026; 170: 330-343. An Exosome-Based Liquid Biopsy for the Detection of Early-Onset Colorectal Cancer: The ENCODER Multicenter Study Methods: A panel of 6 cell-free and exosome-based circulating biomarkers were identified through small RNA sequencing from a biomarker discovery cohort (blood test). Key finding: “This study developed and independently tested a blood-based test with 97.3% sensitivity for screening-relevant CRC stages I–III and 61.5% for the noninvasive detection of high-grade dysplasia.”
RM Califf et al. N Engl J Med 2026;394:4-6. A Threat to Evidence-Based Vaccine Policy and Public Health Security at the FDA
This editorial by 12 former FDA commissioners of both Democratic and Republican administrations is sharply critical of recent policy changes at the FDA which threaten the supply of life-saving vaccines.
Here is an excerpt:
“The existing regulatory model builds public trust by encouraging open information exchange and rigorous, transparent scientific debate. Yet a memo sent last week to FDA staff will upend core policies governing vaccine development and updates…
The memo (available at https://www.biocentury.com/article/657740) was written by Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), who also serves as the agency’s chief scientific officer, chief medical officer, and acting head of CBER’s office of biostatistics, as well as overseeing the division responsible for vaccine review and approval. His memo characterizes the actions of FDA scientists who express concerns about agency processes or decisions to outside parties as “unethical” and “illegal.” It calls for scientific debates to be kept within the agency “until they are ready to be made public,” and instructs staff members who disagree with the new framework to “submit your resignation letters.”..
If enacted, the framework would impede the ability to update vaccines to keep up with the natural evolution of respiratory viruses or changes in the prevalence of bacterial serotypes…
The new framework rejects the agency’s long-standing reliance on “immunobridging” studies for well-understood vaccines with extensive safety data. Using this approach, once a reliable correlation with effectiveness has been established, a vaccine’s ability to stimulate the immune system to produce protective antibodies can serve as a surrogate for its efficacy in helping patients avoid infections and complications from rapidly evolving viruses such as SARS-CoV-2 and influenza. Because these viruses change frequently, repeating large-scale efficacy trials for every new seasonal strain is not feasible within the time needed to update the vaccines…
Abandoning the existing methods won’t “elevate vaccine science,” as the memo asserts. It will subject vaccines to a substantially higher and more subjective approval bar. The proposed measures will slow the replacement of older products with better ones and will create potentially prohibitive expenses for new market entrants…Moreover, insisting on long, expensive outcomes studies for every updated formulation would delay the arrival of better-matched vaccines when new outbreaks emerge or when additional groups of patients could benefit…
The new approach would also evade public transparency, including long-standing statutory and regulatory mechanisms that enable disagreements about benefit–risk balance, clinical trial end points, trial design, and data analysis to be aired in public…
The benefits and risks of many established vaccines are well understood, and imposing the new approval requirements without meaningful new evidence could make it impossible to keep up with evolving infectious threats.
The memo asserts, incorrectly, that “we do not have reliable data” on the benefits of Covid vaccination in children. Reasonable scientists should engage in open debate about how best to shape recommendations for children at lower risk for Covid-19, but substantial evidence shows that vaccination can reduce the risk of severe disease and hospitalization in many children and adolescents…
Americans’ safety depends on a culture in which evidence is reviewed openly and staff can surface concerns, challenge leadership, and engage with external scientists without fear of reprisal.
In a nearby neighborhood, my wife and I went walking and came across a “free art” stand which looked similar to a “free little library” stand. We picked out this small piece (about 5 inches on each side).
Last week, the following article explained why the newest changes, announced yesterday (see link below), to the vaccine schedule recommendations are not a good idea:
“Proponents of the push to align U.S. recommendations with those of so-called peer nations such as Denmark, Japan and Germany — all of which recommend fewer shots than the United States — have billed it as a common-sense corrective. But, as innumerable doctorsandscientists have explained, when it comes to public health, countries with fewer shots on their must-have list are not actually our peers.
In Denmark, to take the administration’s favorite example, prenatal care is free and universal. More than 95 percent of pregnant women are screened for hepatitis B, and those who test positive are promptly treated and duly monitored…
None of this is true in the United States.
Here, nearly a quarter of pregnant women lack adequate prenatal care, and those who face the highest risk of contracting and spreading vaccine-preventable diseases are often the least likely to have access to doctors or pharmacies. When U.S. health officials tried to stamp out hepatitis B through vaccination programs aimed at high-risk groups, they failed miserably. It was not until they carried out a universal, at-birth vaccination policy in 1991 that hepatitis B infections finally plummeted — by about 99 percent.
In fact, if the U.S. public health system has one thing going for it relative to other nations, it’s probably vaccines. As the C.D.C.’s own data indicates, routine childhood vaccination has prevented hundreds of millions of illnesses and tens of millions of hospitalizations here. It has also saved half a trillion dollars in medical costs, a figure that jumps into the multitrillions once you factor in indirect, societal costs like lost productivity and lost wages.
The United States tends to have higher rates of measles vaccination than Europe, and fewer measles cases as a result. Compared with Denmark, we also tend to have lower hospitalization rates for rotavirus (which causes diarrhea and can be fatal in infants and children) and respiratory syncytial virus, or R.S.V. (which is a leading cause of hospitalization among children). The reason for those disparities is not in dispute: We vaccinate routinely against both viruses. Denmark does not…
In the meantime, the Food and Drug Administration is angling to make an even bigger and more enduring impact on Americans’ access to vaccines…top officials at the agency have proposed a roster of new requirements for the shots, including several that critics say would be logistically impossible and could leave us with no F.D.A.-approved Covid or flu vaccines…
We don’t have to wonder what that future will look like. We can glimpse it already in communities across the country where measles and whooping cough are resurgent and where infants and young children have already died from both. We can also see it foretold in the current flu season: This year’s flu vaccine has proved an imperfect match to the currently circulating strains. New shots, based on mRNA technology, would have one day enabled us to avoid this kind of misfire. But the nation’s leaders have imperiled that future with the decisions they made this year…
Mr. Kennedy has brought us to this precipice by aggressively subverting nearly every process and protocol that previously governed our public health institutions. He has granted political appointees enormous sway over agency scientists. He has excluded people with meaningful expertise from his planning and deliberations. And he has fired dissenters all the way up to the C.D.C. director and replaced them with lackeys, sycophants and wellness grifters.”
My take: RFK Jr and this administration has already done great damage to our health care and the toll will be evident for a long time. But, they are not done yet.
Link to yesterday’s announcement: NY Times 1/05/25: Kennedy Scales Back the Number of Vaccines Recommended for Children“Public health experts expressed outrage at the sweeping revisions, saying federal officials did not present evidence to support the changes or incorporate input from vaccine experts…and will endanger the health of children in the United States…The C.D.C.’s new schedule continues to recommend vaccines against some diseases, including measles, polio and whooping cough, for all children. Immunization against six other illnesses — hepatitis A, hepatitis B, meningococcal disease, rotavirus, influenza and respiratory syncytial virus, the leading cause of hospitalization in American infants — will be recommended for only some high-risk groups or after consultation with a health care provider.”
This article focuses on the experience of a transgender patient who recorded unfavorable remarks while under anesthesia.
An excerpt:
On the recording, the health care workers express a variety of opinions about transgender identity more generally….And in the middle of the conversation, one person suggests updating Ms. Capasso’s medical file. “Yeah, it needs to say ‘male,’” the person says.Ms. Capasso said it appeared that hospital staff had in fact changed her electronic medical records, all while she was unconscious…
Ms. Capasso insists that she was not trying to catch the medical staff speaking disrespectfully about her. She said she was motivated by curiosity and a desire to know exactly what the surgeons discovered. It may not be such an unusual impulse.
Dr. Alexander Langerman, a surgeon at Vanderbilt University Medical Center, led a medical conference in 2021 on surgical recordings.
There is often “a really strong desire by patients to know what happened to them in the operating room,” Dr. Langerman said. “And, I think, a valid right to know what happened.”
Surgery was once a relatively public event — operating rooms were called “theaters” for a reason. But infection control and malpractice litigation pulled the operating room out of public view.
“Operating rooms and surgery have become one of the most secretive environments in modern society,” said Dr. Teodor Grantcharov, a Stanford University professor who started a company that uses operating room recordings to improve patient safety and hospital efficiency.
My take: While a patient is under anesthesia, it is best to treat them in the same manner as if they were awake.
“The true test of a man’s character is what he does when no one is watching.”
Between the end of February and mid-August, funding ceased for 383 studies that were testing treatments for conditions including cancer, heart disease and brain disease. The cuts disproportionately impacted efforts to tackle infectious diseases like the flu, pneumonia and COVID-19, researchers found…
More broadly, the lost research harms patients who could have benefited from a possible new treatment, researchers said in the report published Monday in the journal JAMA Internal Medicine…
“The whole purpose of these clinical trials is to generate evidence on what works and doesn’t work in medicine,” said study co-author Anupam B. Jena with Harvard Medical School. Researchers counted 11,008 NIH-funded studies during the study period. Of those, 1 in 30 lost funding.
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 article reviews the growing health concerns regarding microplastics and nanoplastics (MNPs) specifically regarding the GI tract.
Key points:
“As these [plastic] products degrade, they break down into smaller particles, forming microplastics (< 5 microm) and nanoplastics (<1 microm), collectively referred to as MNPs”
“Although many plastic products are deemed recyclable, in the United States, less than 10% are actually recycled…annual global production projected to reach 1.1 billion tons by 2025. Simultaneously, over 12 billion tons of plastic wastes are expected to accumulate in landfills”
“The average American ingests approximately 5g of plastic per week, equivalent to 1 credit card, and 39,000–50,000 particles annually”
Potential association of MNPs with metabolic-associated steatotic liver disease, liver and pancreatic cancer and inflammatory bowel disease. “Studies have reported significantly higher levels of MNPs in patients with IBD compared with healthy controls.”
In a related article in Gastroenterology and Endoscopy News (October 2025), Dr. Johnson noted that “reduction of plastic intake from bottled water to tap water in one study reduced microplastic intake, the number of particles within human tissues, from 90,000 to 4,000…Avoid heating food in plastics…the effect of microwave increased the evidence of microplastics by over 4.2 million and the nanoplastics, 2 billion, just in three minutes in the microwave.”
My take: Something that almost everyone could agree on – they would like less plastic in their food and environment. How to achieve this is much more difficult.
EJ Shapiro. NEJM 2025; 393: 1360-1361. “You Still Going to be Doing This?”
This commentary mirrored a lot of my recent experience. The author is startled at how patients are asking if he will still be taking care of patients in a few years and how he has enjoyed being a clinician.
Here is an excerpt:
At first, I was startled — I’d never seriously considered the timeline of my own career…Whether it was thanks to luck, sound reasoning, some resolution of my cognitive dissonance, or (least likely) an easy disposition, I mostly enjoyed the ride. Medical school flew by…every rotation opening a new world…As a resident, then a fellow, I learned the delicate balance between personal responsibility and teamwork required in caring for patients facing the range of problems…
Then…I …realized that my opinion — no discussion with the team, no attending cosignature, just mine alone — would guide this patient’s care… So many lives shared, some with laughter, less often with tears. Many of them I helped, and some I probably didn’t…
I realize the time has come to try to figure out the answer to, “Are you still going to be doing this?” But the decision doesn’t come easily. On a day-to-day basis, I love what I do, mostly because of the connections with those patients, and the nurses, techs, secretaries, medical assistants, and my partners (some of whom are now in my children’s age group). Also because medicine always changes and always fascinates.
Of course, prior authorizations, electronic medical record snafus, obtuse hospital administrators, and sometimes the clinical demands can feel oppressive… But… when I go into the exam room, close the door, greet the patient, and begin our visit, none of those structural irritants matter. We explore their situation and try to figure out how to move forward. The challenge and respect of that task never really pale…
Still, all the other passions, affections and hobbies, grandchildren, books, and mountains call out…And… I’d rather go when the reaction from the people left behind will be regret rather than relief…
I still have some things to consider before I put that full stop on my medical career, but maybe at some point the choice will become clear — like the one that long ago began it. Everything has its season.
My take: Though I am not ready to retire, I am getting the question from families about when I might and have started to think about the next season.
The AAP and more than 40 other medical, health and patient advocacy groups also issued a joint statement condemning the change and called on the CDC to “return to its long history of promoting evidence-based information.”
Potential links between vaccines and autism have been studied for decades. More than 40 high-quality studies in seven countries involving over 5.6 million people have found no connection.
“The conclusion is clear and unambiguous: There’s no link between vaccines and autism,” Dr. Kressly said. “Anyone repeating this harmful myth is misinformed or intentionally trying to mislead parents.”
Scientists believe there is no single root cause of autism. Interactions between genetic changes and environmental influences likely play a role, according to an AAP Fact Checked article. Improved awareness and screening and updated diagnostic criteria have contributed to increases in autism prevalence.
“At this point, it’s not about doing more studies. It’s about being willing to accept what the existing studies clearly show,” said Alison Singer, M.B.A., co-founder and president of the Autism Science Foundation.
She said spending more money on settled science takes funding away from research on genetics and services for autistic people. False claims further stigmatize autistic people and their families…
Sean T. O’Leary, M.D., M.P.H., FAAP, chair of the AAP Committee on Infectious Diseases, called the latest move to put misinformation on the trusted CDC website “madness” and “a tragic moment for this country” and said he does not blame the career CDC scientists.
“For many decades, we (could) rely on CDC to provide the American public with the best available science,” Dr. O’Leary said. “Now our government is using it as an apparatus to spread falsehoods and lies.”
Here is a screenshot on media coverage of this story:
gutsandgrowth 