The Politicization of Science and Outcomes for Health Care

Yesterday’s blog post highlighted how the current policies are leading to a brain drain, undermining economic advangages and harming our ability to improve outcomes for patients.

Today’s post summarizes a recent editorial by the NEJM editors (NEJM 2026; 395: 187-188. The OMB and the Politicization of Science) that drills down on three specific proposals by the OMD to change research policy.

An excerpt:

“For decades, the Soviet Union promoted the unorthodox views of Trofim Lysenko, an agronomist who used his close ties to the political leadership to spread misinformation denying Mendelian genetics. What followed was a disaster: many years of poor harvests based on unsupported science and suppression of the teaching and practice of modern genetics throughout the Soviet bloc. A similar threat now hangs over U.S. science…

The rule changes that the White House Office of Management and Budget (OMB) recently proposed to the Health and Human Services (HHS) grant process would drastically change this process. There are too many objectionable aspects of these proposals to discuss here. But three are particularly striking. Political appointees would be able to make funding decisions and could ignore the advice of independent scientists. They could also stop funding midway through the promised grant period. And they would institute new rules, including rules severely limiting foreign interactions…

Expert, independent peer review of grant applications is essential for directing NIH dollars to research that has the greatest potential for advancing science and improving health. Selecting the most promising research is an enormously complex and challenging undertaking…

The OMB proposal to permit political appointees to discontinue funding of ongoing grants at any time, without cause, would have serious adverse consequences for the research enterprise and for patients…the gold standard of evidence is the randomized, controlled trial (RCT). The RCT’s methods minimize the influence of bias and preconceived notions. However, this type of trial often takes years to conduct…If a decision to stop funding the trial occurred at year 4 for political rather than scientific reasons, what would happen to patients who were enrolled in the study at that time? How would longer-term safety and efficacy observations be made?…Can physician–investigators ethically enroll a patient in a trial if ongoing funding for the trial is uncertain?

There would be substantial adverse effects on researchers as well as patients. Why would a basic science investigator start a line of investigation that might take years to complete if the funding for it could be cut at any moment, without cause?…A corrosive consequence of such an arbitrary funding process would be the diminishment of the U.S. workforce of clinical and basic science investigators — and it would ultimately harm biomedical innovation and cutting-edge patient care…

The proposed rules would also severely limit foreign research partnerships, requiring political approval of international collaborations…Broad global collaboration has led to…studies [which] can be completed years earlier than they would be otherwise, at a fraction of the cost, bringing earlier and greater benefits to all affected people, including people in the United States. Aren’t we better off addressing Ebola, tuberculosis, or screwworm before they spread to additional communities?” 

My take: Allowing politicians to arbitrarily choose which research to fund rather than those with the greatest merit will lead to a poor harvest of scientific advances for all of us. This would, however, enable a select few to benefit from their corrupt connections to steer more money into their greedy pockets.

Boardwalk at Arablia Mountain Trail

Scientific Excellence Leaving U.S.

Numerous articles have documented the abrupt changes to research funding by this administration.

I will focus on the first article but the others provide additional insight into this issue.

An excerpt:

Omar Yaghi, an immigrant to the United States who shared last year’s Nobel Prize in Chemistry, has left his faculty post at the University of California, Berkeley, for one in China, where he will lead an institute using artificial intelligence to accelerate the discovery of new materials…

Last year, three of America’s six winners of science Nobels were born outside the country. In this century, overall, the émigré fraction for U.S. Nobels in physics, chemistry and medicine now stands at 40 percent

Last year, before flying to Stockholm to receive his Nobel Prize, Dr. Yaghi in an interview with The New York Times voiced concern about Mr. Trump’s immigration policies, saying that they endanger the nation’s system of universities, companies and governments that promote scientific excellence…

My take: The arbitrary cuts and policy shifts have undermined an engine for American prosperity, stalled the development of medications for numerous disorders, imperiled thousands of patients enrolled in clinical trials. and resulted inthe loss of enormous scientific/medical talent.

Related blog posts:

“Businesses Race to Cash in on Peptide Craze”

SA O’Brien. WSJ 6/23/26: Businesses Are Taking Risks to Cash In on the Peptide Gold Rush

An excerpt:

Doctors, telehealth companies, med spas and venture capitalists are racing to get in on the craze for injectable drugs…

Demand for restricted peptides has fueled an online gray market for injections promising youth, beauty and strength. American businesses are racing—and taking risks—to get in on the craze…

These drugs, which advocate a D.I.Y. approach to health and longevity, are largely unapproved by the Food and Drug Association, meaning they can’t be marketed or sold for human consumption in the U.S. But with the support of Health Secretary Robert F. Kennedy Jr., several popular peptides will soon be up for reclassification, paving the way for a multibillion-dollar wellness gold rush.

Telehealth companies are already building infrastructure for a future where compounding pharmacies can safely provide experimental peptides…

Some longevity doctors and medical clinics are selling peptides directly to patients, obtaining substances both domestically and from abroad. Alabama’s Board of Medical Examiners released a statement in May underscoring its stance against doctors “recommending, supplying, prescribing or administering these substances.”

Wilson Hunter, the board’s general counsel, said the statement was prompted by unapproved peptides popping up in audits and investigations, via consumer complaints and as physicians inquire about guidance. “We’re not anti-peptide, we’re just anti people hurting themselves because they’re getting products that aren’t vetted or verified,” Hunter said.

In late July, the FDA’s Pharmacy Compounding Advisory Committee is set to discuss whether to greenlight seven unapproved peptides… could represent a $2.2 billion telehealth market opportunity next year…

Bill Holtz, a life sciences and U.S. Food and Drug Administration regulatory and policy strategist at Foley & Lardner LLP, said the compounding pharmacies producing the previously restricted peptides are doing so without explicit permission from FDA…

My take: Some peptides, like insulin, can be life sustaining. However, peptides that are being marketed for skin care, muscle strength and wellness are unproven and carry potential risks. In addition, like many other poorly-regulated products, there may be issues with product quality and contaminants. Long-term effects and even proper dosing are unknown.

Related blog posts:

Camp Weekaneatit 2026

Last Sunday, along with my colleagues, Jeff Lewis, and Nirav Patel, I helped check in kids for Camp Weekaneeatit! (glutenfreecamp.org). This is a gluten-free camp for youth with ​Celiac Disease and ​Gluten Intolerance. This year’s staff shirt was “S’more Fun Without Gluten;” though, I elected to wear my T-shirt from 2018.

The camp was started more than 15 years ago by my partners, Dr. Jeff Lewis and Dr. Bill Meyers.

The camp is located just north of Atlanta at Ft Yargo (Winder, Georgia). The ~125 participants come from all over the U.S including Texas, Michigan, Ohio, Massachusetts, Colorado, Arizona, Florida, South Carolina, and Alabama. There was one kid, whose father is a marine, who flew in from Japan!

Most of the campers have come several times and have had a great experience. Here is an excerpt from a letter from a camper’s parent:

My daughter was at camp with you this summer.  I can’t tell you how much fun she had.  She was diagnosed with celiac when she was just 2, so she has never known a world where she could just relax and be like everybody else.  Camp gave her so much freedom, and she grew so much in just one week.  Today is her birthday and her first day of school.  Her camp friends have already texted to wish her happy birthday!…This is the first time she has had friends with celiac disease — I can only imagine how much more supported that makes her feel…  I asked her what it was like to not have to ask a million questions before every bite she ate.  She said, “I felt like I didn’t even have celiac disease all week. I felt like a normal person.” 

Last year enrollment started in the middle of November for summer 2026. Space is limited!

Related blog posts:

Surprise, Surprise – Measles Cases in South Carolina Occurred Where Vaccinations Are Lowest Plus One

EA Serman, B Witrick, L Rennett. NEJM 2026; DOI: 10.1056/NEJMc2604004.
Clusters of Concern — Spatial Link between Childhood Undervaccination and Measles Outbreaks in South Carolina

An excerpt:

As of April 8, 2026, South Carolina had 997 confirmed cases of measles, of which 95.3% were reported to be among unvaccinated residents.2 Of these cases, 90.8% occurred in children (<18 years of age).2 Thus, school-based vaccination patterns provide a reasonable indicator of local pediatric susceptibility in the communities where transmission has occurred…

Spartanburg County (population, 380,000) was identified as the dominant cluster, containing 27 of 109 hot-spot tracts (24.8%). Of the 997 reported measles cases in the state, 940 (94.3%) occurred in Spartanburg County…

The mean vaccination coverage was lower in the schools with reported measles cases (coverage, 83.9%) than in those with no reported cases (coverage, 92.9%)…The locations of the 30 schools with measles exposure were not uniformly distributed: 26 (87%) were located within or adjacent to undervaccinated hot-spot tracts

In other health news, there is a reason why milk is pasteurized:

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Two Games and Vulnerabilities with Generic Drugs

For those of you who like online games, there are two that I recently discovered that are quick and fun. Currently, both games are free.

  • MapTap.gg Daily geography game. Each day, the game asks you to identify 5 locations on a realistic unmarked 3D globe. The closer your guess, the higher your score. Each day there are short vignettes and facts.
  • Anno-Game Daily history game. Each day, the game asks you to determine the year of 5 important historical events. The closer your guess, the higher your score.

K Schulman, AL Kellermann. NEJM 2026;394:1669-1672. Substandard Generic Drugs — Threats to Patient Safety and National Security

An excerpt:

Generic drugs account for more than 90% of prescriptions filled in the United States. The first paragraph on the home page of the Office of Generic Drugs at the Food and Drug Administration (FDA) asserts that “FDA-approved generic drugs have the same high quality, strength, purity and stability as brand-name drugs.” On the strength of this assurance, America’s doctors, pharmacists, and patients assume that every version of a generic drug is equally safe. But this proposition is now being seriously challenged...

Between 2009 and 2019, the availability of generic medicines saved U.S. patients $2.2 trillion, according to the FDA.

Over time, intense price competition drove most production of generic drugs and ingredients offshore to countries with low labor costs and lax regulatory controls. Once that shift occurred, relentless pressure to minimize costs led some manufacturers to compromise on quality. Rapid globalization also outstripped the FDA’s capacity to monitor manufacturers. In 2022, the Government Accountability Office reported that 61% of foreign plants had not been inspected by the FDA in the preceding 5 years.1

When FDA inspectors finally reach these plants, some find glaring problemsMore than 60% of generic-drug shortages are attributable to quality concerns, according to the FDA…

A private-sector laboratory detected high levels of nitrosamines (known carcinogens) in drugs made by several FDA-approved manufacturers, prompting recalls of metformin, angiotensin-receptor blockers, angiotensin-converting–enzyme inhibitors, prazosin, and ranitidine. More recently, independent tests of generic methylphenidate found nitrosamine levels above the FDA’s safety threshold in 7 of 15 immediate-release products…2

Recently, a team of U.S. and South Korean researchers with access to FDA data determined that significantly more serious adverse event reports were linked to generic drugs manufactured in India than to equivalent drugs manufactured in the United States4

In 2008, a total of 238 deaths in the United States were linked to adulterated Chinese heparin. When the FDA toughened its approach to quality assessment of foreign manufacturers, shortages of more than 200 medications followed. This crisis prompted the FDA to prioritize minimizing drug shortages over ensuring safety… 

There is a better way to assure the safety of generic drugs. In 1994, the European Medicines Agency (EMA), for example, established a proactive approach involving risk-based surveillance in addition to systematic planned and ad hoc testing of generic drugs both on the market and during routine inspections of manufacturers (in contrast, the FDA does not routinely test generic-drug products themselves, either on the market or during quality inspections of manufacturing plants). EMA testing relies on a network of official medicines control laboratories (OMCLs) that operate in accordance with International Organization for Standardization (ISO) accreditation standards for testing and calibration laboratories. At any point in a drug’s life cycle, an OMCL can pull samples for product testing...

The U.S. government should oversee an effort to rebuild America’s capacity to manufacture generic drugs, combining investment in private manufacturing with incentives for purchasing U.S.-made products under the Medicare and Medicaid programs. Currently, the United States is vulnerable to an embargo of essential drugs or the materials required to make them. A recent evaluation for the Department of Health and Human Services found that 87% of sites that make active pharmaceutical ingredients (APIs) and 63% of sites that produce finished dosage forms were located overseas

My take (borrowed from the authors): Most generic drugs are safe, but a troubling minority are not…The United States already tests a wide range of consumer products. We should also test our generic drugs.

Related blog posts:

Iguazu Falls

How Much Exercise is Needed for Optimal Cardiovascular Protection?

Liang Z, Du S, Zhao S, et al. British Journal of Sports Medicine Published Online First: 19 May 2026. doi: 10.1136/bjsports-2025-111351. Open Access! Joint non-linear dose–response associations of device-measured physical activity and cardiorespiratory fitness with cardiovascular disease: a cohort and Mendelian randomisation study

Methods: This accelerometer-based prospective cohort study using the UK Biobank analyzed 17,088 participants. There were 1233 incident cardiovascular disease events which occurred over a median follow-up of 7.85 years.

Key findings:

  • “Meeting the 150 min/week guideline yielded a modest ~8%–9% risk reduction across fitness levels, whereas achieving a >30% risk reduction required threefold to fourfold higher volumes (~560–610 min/week)”
  • “Approximately 11.6% of participants, 1980 of 17,088, achieved at least 560 min per week, indicating that although such volumes are attainable, they represent a high behavioural threshold for most individuals”
  • Limitations: the cohort is likely healthier and fitter than the general population, reflecting a healthy volunteer bias

My take: More moderate-to-vigorous physical activity (MVPA) is associated with better outcomes. Current recommendations of 150 min/week offer benefits but more time is associated with optimal cardiovascular protection.

Kiawah Island at low tide

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Essential Summer Safety Tips for Preventing Drowning

I am reposting this from last year with slight modifications.

An ICU colleague indicated that she really does not like to work on summer holiday weekends. While she is a hard worker, what she doesn’t like is seeing kids with drowning and firework injuries. All of a sudden a happy time becomes tragic. With that in mind, here are a few tips to prevent drowning.

From Strong4Life: “Practicing water safety for kids of all ages is crucial because drowning is a leading cause of death in children from birth through the teen years. And drowning is often quick and silent.”

Also, firearm deaths are the leading cause of death in children in the U.S. and motor vehicle accidents are second. So, firearms need to be secured and drive safely on the way to the pool, lake, river or beach.

Related blog posts:

C Raymond-King et al. N Engl J Med 2026;394:1958-1959. Open Access!
Current Causes of Death among Children and Adolescents in the United States

HHS Removes Experts from United States Preventive Services Task Force (USPSTF)

AMA Statement:

Related blog posts:

AI Pilot Prescription Renewal in Utah

S Gerke et al. NEJM 2026; 394: 1561-1563. Utah’s Prescription-Renewal Pilot Program — Autonomous AI Managing Patient Care

An excerpt:

In January 2026, Utah rolled out a 12-month pilot program involving an AI system developed by health tech startup Doctronic that autonomously renews certain prescriptions for people with chronic conditions…1,2

Although the program is limited to prescription renewals for 192 commonly prescribed drugs (see box),1,2 it could pave the way for expanded initiatives that include additional products, autonomous initial prescribing, and broader geographic areas…

One question is whether it targets a clinically meaningful problem. The stated purpose is to address medication nonadherence…Automated medication-refill programs for various classes of drugs, including antihypertensives, lipid-lowering agents, and antidiabetic agents, have meaningfully increased adherence…4

Autonomous renewal would be inappropriate for medications requiring frequent dose adjustments or in patients whose clinical status could change rapidly…physician oversight to detect early signs of toxic effects, disease progression, or changing organ function that would necessitate dose modification…AI-based refill generation without a defined end point may preclude opportunities for physician–patient discussions that could curb polypharmacy or medication overuse.

The Utah program could also present legal problems. Doctronic’s AI system, which reportedly hasn’t been reviewed by the Food and Drug Administration (FDA),1 should probably be considered a device under the Federal Food, Drug, and Cosmetic Act (FDCA)…

Another FDCA provision specifies that dispensing a prescription drug constitutes misbranding — a violation carrying potential civil or criminal penalties — unless it occurs “upon a written prescription of a practitioner licensed by law to administer such drug” or upon an oral order that is promptly turned into a written order by the pharmacist…

It is unclear whether Utah’s AI system complies with these requirements. Even if Utah allows AI-based prescribing in the absence of supervision by a licensed physician or other prescriber, federal law would preempt state law…

The FDA may decide to look the other way and allow this experiment to continue, leaving clinicians and patients without safety assurances amid an extraordinary expansion of autonomy for AI.

My take: There may be many situations in which agentic AI would be helpful with pharmacy management. However, until this technology is proven to be safe, like all other devices, it should be limited to situations in which the prescribing physician is in agreement with this process.

Related blog post:

Peony (blooms here in late April)