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Friday, June 20, 2025

On chronic disease prevention, RFK Jr.'s actions speak louder than words

Secretary of Health and Human Services Robert F. Kennedy, Jr.'s agenda, he says, is chronic disease prevention. He wants Americans to eat fewer ultra-processed foods; to decline long-established childhood vaccines against diseases like the measles, which we never see anymore; and to drink public water supplies without fluoride, apparently as a boon to the dental profession. HHS recently announced that it will spend $10-20 million on a "Take Back Your Health Campaign" that is intended to "alert Americans to the role of processed foods in fueling the diabetes epidemic and other chronic diseases, inspire people to take personal responsibility for their diets, and drive measurable improvements in diabetes prevention and national health outcomes."

Diabetes is a big problem. I'm all for preventing diabetes through healthier eating. But the longest-running longitudinal study of diabetes prevention, the Diabetes Prevention Program Outcomes study, was terminated in March when the Trump administration froze hundreds of millions of dollars in federal health grants to Columbia University, where the study coordinating center is located:

The lapse in funding means that the Diabetes Prevention Program Outcomes Study can no longer continue to collect patient data as planned; it can no longer pay staff to do blood work, collect urine samples, scan brains, or conduct neurocognitive tests. Even worse, the study’s existing data are at risk. Scientists need funds to properly store and retrieve samples; they need money to pay for computer servers and to hire statisticians and analysts, who clean and curate the data.

HHS has traditionally relied on panels of non-government experts to guide its work in prevention, and after the DOGE-driven cuts that resulted in the departure of 20 percent of its workforce, it needs outside help more than ever. For decades, five independent scientific advisory panels made evidence-based recommendations on clinical preventive services, community preventive services, newborn screening tests, infection prevention, and immunizations. Two of these panels have already been dissolved, and the remaining three are on life support.

I wrote a Medscape commentary about current threats to the U.S. Preventive Services Task Force (USPSTF), which include the hobbling and proposed elimination of its convening agency (AHRQ) and a lawsuit that the Supreme Court should decide any day now. The USPSTF's sister panel, the Community Preventive Services Task Force, which "evaluates evidence and recommends effective interventions to improve health in the community, home, school, work, and health care settings," hasn't been convened at all this year.

The Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC), which since 2003 had been making evidence-based recommendations about a list of conditions for which every newborn should be screened, was disbanded by HHS in April for no particular reason. As a result, states have been left on their own to evaluate new screening tests:

Each year, newborn screening identifies about 14,000 infants with serious conditions that benefit from early intervention. Early detection can prevent death or irreversible harm in disorders like metabolic diseases, immune deficiencies, and muscular atrophies. Eliminating the ACHDNC creates a dangerous vacuum in the nation’s newborn screening system, stalling progress on adding life-saving tests to the RUSP and increasing the risk that diagnoses will be delayed or missed for some babies—with potentially tragic results.

The same fate befell the Healthcare Infection Control Practices Advisory Committee (HICPAC), which was created in 1991 to advise the Centers for Disease Control and Prevention (CDC) on critical infection prevention and control practices. Over the past three-plus decades, HICPAC "advised and worked with the CDC to develop clinical guidelines, training resources, and expert guidance that were subsequently widely used throughout health care settings." Chronic diseases that can be prevented by reducing the risk of transmission in health care include HIV, hepatitis B and C, tuberculosis, and long COVID. HICPAC was dissolved by HHS at the end of March.

Finally, there is the Advisory Committee on Immunization Practices (ACIP), which RFK Jr. first bypassed by making unilateral changes to the COVID-19 vaccine recommendations for children and pregnant women, then remade by firing the entire committee and replacing them with a group that includes a physician who proudly identifies as an anti-vaxxer. This morning, 6 former chairs of the ACIP wrote an Op Ed in STAT that warns about millions of Americans losing access to safe, effective vaccines and the ability to develop new ones in response to future infectious threats:

Without transparent, evidence-based processes, vaccines may become inaccessible, unaffordable, or unavailable. Public trust will erode, innovation will stall, and lives will be lost unnecessarily. The systematic unraveling of our vaccine infrastructure endangers our freedom to protect ourselves and our communities. We urge congressional leaders to reflect on how these fragmented decisions collectively dismantle our ability to prevent disease and save lives.

Public health advocates frequently bemoan political obstacles to investing in evidence-based initiatives aimed at preventing chronic diseases. Today we have an HHS Secretary who is clearly interested in chronic disease prevention, but equally uninterested in evidence or established mechanisms for translating evidence into policy. As a former ACIP member recently told STAT, the message is clear: "Scientific expertise is no longer of use" unless it happens to align with what RFK Jr. already believes to be true. His terrible actions speak louder than words.

Wednesday, June 11, 2025

Pathways to primary care for underserved communities

Several past colleagues in the family medicine department at Georgetown recently published an informative scoping review of specialty disrespect in the medical learning environment. As they point out, specialty disrespect (also known as bad-mouthing) is common, based on "stereotypes, biases, and perceived specialty hierarchies," and play a significant, but not dominant, role in specialty choice. Although I don't recall experiencing overt disrespect when I told residents and attendings at my subspecialist-oriented medical school that I planned to practice primary care, unspoken assumptions about what I'd need to know as a family doctor sometimes led to my being assigned to patients with less challenging medical problems or greater social needs. Most family physicians have at some point heard the old saw "jack of all trades, master of none," which I have come to view as less insulting than is usually intended. (Wouldn't most people prefer to hire a single handyman to make several miscellaneous home repairs rather than a bunch of specialists in each area?)

A research study in Health Affairs charts "physicians' trajectories from medical school graduation through postgraduate training into primary care specialties" for MD, DO, and international medical graduates from 2001-15. The authors term "primary care yield" as the percentage of physicians who start training in primary care and complete it in primary care. So, a family physician who does a geriatric fellowship would count as positive primary care yield, while a physician who starts training in internal medicine and ends up a gastroenterologist would not. Unsurprisingly, they find that 97% of physicians who enter family medicine residency programs become primary care physicians, while the corresponding figures for internal medicine and pediatrics are 35.5% and 54.4%. Schools with primary care pathway programs that send a majority of students into non-family medicine residencies may not be creating future primary care physicians.

It's well documented that schools that are ranked highly by U.S. News & World Report produce a lot of subspecialists, while schools ranked highly by social mission graduate relatively more primary care physicians. A research letter in JAMA Network Open reported that in 2015 and 2020, graduates of U.S. News's top 20 medical schools were less than half as likely to be practicing in socioeconomically deprived areas compared to other medical graduates, and among physicians, family and emergency medicine were the most likely to practice in these areas. 

At the residency level, federal investments in rural and federally qualified health center (FQHC)-based programs have resulted in significant training expansions in underserved settings. Another Health Affairs study documented that the percentages of residency programs with rural and FQHC training sites rose from 6.2% and 3.6%, respectively, in 2008-09 to 14.3% and 11.2% in 2023-24. Training health professionals in FQHCs is essential to staffing those FQHCs and improving community health in the future; when community health centers close, county-level mortality increases, as illustrated in another study. Of note, the Trump administration's HHS reorganization plan and the "one big, beautiful bill" passed by the House of Representatives would eliminate the agency that funds, and most of the funding for, these training programs.

Sunday, June 8, 2025

Health professionals speak out against the new nuclear arms race

During the Cold War, the United States and the former Soviet Union amassed nuclear weapon stockpiles with a collective destructive power hundreds of thousands of times that of the two bombs that obliterated the Japanese cities of Hiroshima and Nagasaki in August 1945. After peaking at more than 70,000 in 1986, the absolute number of weapons gradually declined from the implementation of various arms control treaties to 12,331 today. However, as stated plainly in a recent editorial published in more than 120 medical journals worldwide, “This does not mean humanity is any safer.” The authors urged readers to make the elimination of nuclear weapons an urgent public health priority, reiterating a 2023 editorial on similar themes:

Any use of nuclear weapons would be catastrophic for humanity. Even a “limited” nuclear war involving only 250 of the 13,000 nuclear weapons in the world could kill 120 million people outright and cause global climate disruption leading to a nuclear famine, putting 2 billion people at risk. A large-scale nuclear war between the US and Russia could kill 200 million people or more in the near term, and potentially cause a global “nuclear winter” that could kill 5 to 6 billion people, threatening the survival of humanity.

The last of the nuclear arms accords, the New START treaty between the United States and the Russian Federation, is set to expire in 2026. Both countries are spending enormous amounts to modernize their existing arsenals. A 2024 editorial in Science, noting rising tensions between the United States and Russia, China, and North Korea, observed that “the risk of nuclear war has not been so high since the Cuban Missile Crisis.” The historical events depicted in the Academy Award–winning film Oppenheimer are no longer just history; at New Mexico’s Los Alamos National Laboratory, for the first time in decades, the United States has resumed building plutonium cores. Despite safety precautions, factory workers and bystanders will be at high risk of radiation exposure and subsequent cancer, lung, and kidney problems.

The world is woefully unprepared for the health consequences of the use of a single nuclear device, much less a nuclear war. In 2024, the New York City Department of Health held a series of workshops on hospital emergency responses to an improvised nuclear detonation by a nonstate terrorist actor. Health professionals who survive a nuclear explosion (90% of those in Hiroshima were killed instantly) would likely face a catastrophic loss of communications, impassable transportation routes, and “risk their lives amid destroyed infrastructure, dangerous radioactivity, and limited healthcare facilities and supplies.”

At last month’s World Health Assembly, the World Health Organization (WHO) overwhelmingly passed a resolution to update Cold War era reports on the health and environmental effects of nuclear weapons and war by 2029. (The United States was absent, having withdrawn from the WHO in January.) Doctors have been at the forefront of campaigns against nuclear weapons since 1961, when Physicians for Social Responsibility was founded. The organization, which later expanded its list of “gravest threats to health and survival” to include excessive military spending, fossil fuels, and climate change, provides education on the health effects of nuclear testing and reality checks on government messages (eg, duck and cover) that suggest that nuclear war could be survivable. A current exhibit at Harvard University’s Countway Library highlights the social activism of former medical school and public health faculty.

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This post first appeared on the AFP Community Blog.

Friday, May 30, 2025

Lung cancer screening in primary care: more pragmatic research needed

The US Preventive Services Task Force, the American Academy of Family Physicians, and the American College of Chest Physicians recommend annual low-dose computed tomography (CT) screening for adults 50 to 80 years of age who have at least a 20 pack-year smoking history and currently smoke or have smoked within the past 15 years. A 2020 meta-analysis of eight randomized controlled trials (summarized in a POEM in American Family Physician) concluded that low-dose CT screening prevents one lung cancer death for every 250 people screened. A 2023 Cochrane for Clinicians article found similar benefits but also noted that for every 10,000 people screened, 363 unnecessary invasive tests are performed. Despite private and public insurance plans fully covering lung cancer screening in the United States, only 10% to 30% of eligible individuals in were receiving it in a recent state-by-state survey.

Barriers to implementing findings from lung cancer screening trials into typical clinical practice include the nonrepresentative nature of research participants (younger, healthier, and less racially and geographically diverse than the target populations) and the superior infrastructure and clinical support available to them. Although an analysis of the National Lung Screening Trial suggested that the eligible people in the United States would experience similar benefits as trial participants, questions about the generalizability of other studies remain.

In a research paper in the January/February 2025 issue of the Journal of the American Board of Family Medicine, Dr. Erin Hirsch and colleagues rated lung cancer screening trials and the nonrandomized Veterans Health Administration Demonstration Project with an established tool that evaluated each study through a primary care lens. Domains included eligibility, recruitment, setting, organization, flexibility of delivery, flexibility of adherence, follow-up, primary outcome, and primary analysis. The investigators scored studies on a 5-point scale, with 1 being completely explanatory and 5 being completely pragmatic. The mean study scores ranged from 2.12 to 3.33, indicating that even the most pragmatic studies fell well short of simulating conditions in community settings.

A lack of pragmatic research may explain why interventions intended to increase lung cancer screening rates have had mostly disappointing results. A systematic review and meta-analysis of intervention studies identified five randomized controlled trials and one prospective observational study. Interventions included patient navigation, outreach calls, and decision aids; control groups received usual care or informational materials. Only two of the studies found statistically significant increases in participation in the intervention group, and a meta-analysis found no difference overall (relative risk = 1.30; 95% CI, 0.74-2.29). A subgroup analysis suggested that multistep interventions targeting multiple barriers may be more effective than single-step ones.

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This post first appeared on the AFP Community Blog.

Tuesday, May 27, 2025

Food for thought on food as medicine

This month, President Trump nominated Dr. Casey Means, a former ear, nose, and throat surgeon who dropped out of residency and reinvented herself as a wellness influencer and New York Times bestselling author, for Surgeon General. I read Means's book, "Good Energy: The Surprising Connection Between Metabolism and Limitless Health," a few months ago. It discourages intake of processed foods, eschews fad diets, aligns with mainstream nutrition guidance (e.g., Michael Pollan's pithy "eat [real] food, not too much, mostly plants"), and has received positive reviews in publications ranging from NPR to Family Medicine.

My main concern about the book is that it seems aimed mostly at well-off households with the health literacy and leisure time to read self-help books and the disposable income to do most of their shopping at farmer's markets and Whole Foods stores. If Dr. Means ends up being confirmed by the Senate, she should consider writing a sequel ("Great Energy"? "Good Energy for the Budget-Conscious"?) for the 11 million families headed by single parents who often work two or more jobs to get by and have fewer options for buying groceries. For these families, the healthiness of food may not be their top priority. A Pew Research Center survey found that overall, Americans ranked taste as the most important factor in choosing food, followed by cost, then healthiness and convenience. So it isn't enough to tell people what foods are best for their health (or make labels on packaged foods simpler to understand); we also need to make the healthy option the default option.

There is good evidence that federal nutrition programs such as the Supplemental Nutrition Assistance Program (SNAP, previously known as "food stamps") and Special Supplemental Nutritional Program for Women, Infants, and Children (WIC) improve health. A Research Letter in JAMA documented increases in food insecurity and days with poor physical health after the end of a temporary pandemic increase to SNAP benefits in March 2023. An Agency for Healthcare Research and Quality evidence synthesis that I previously discussed showed that WIC improves important maternal and child health outcomes. Conversely, a longer-term study suggests that food insecurity in childhood increases cardiovascular risk and obesity in young adulthood, since one is more likely to eat excess food of poor nutritional value if they don't know where their next meal is coming from.

Although I support banning soda purchases from SNAP, eliminating food insecurity by making the program more generous could have an equally beneficial an effect on health. Currently, a four-person household in Pennsylvania must earn less than $62,000 per year to be eligible for SNAP, and the average benefit is $6 per day, or $42 per week. A national program that provided low-income adults with additional vouchers averaging $63 per month for produce purchases (the majority of households were already enrolled in SNAP and/or WIC) led to improvements in food security, diabetes control, weight loss, and blood pressure.

In a recent statement, the U.S. Preventive Services Task Force found insufficient evidence to assess the benefits and harms of screening for food insecurity in health care settings. That doesn't mean that targeted "food as medicine" programs, which should be "understood as complementing and not supplanting existing food and nutrition assistance programs," can't be effective. Ten states have piloted Medicaid managed care projects to address poor nutrition as a health-related social need and use health care dollars to pay for food pharmacies, healthy food vouchers, and medically tailored meals. 

It's worth noting, though, that these promising programs are likely to be defunded if the nearly $1 trillion in Medicaid and SNAP cuts in the recent federal budget bill passed on a party-line vote by the House of Representatives eventually becomes law. Either way, I will continue giving to our local food bank, as the prescription for food insecurity is food, and hungry patients do not make healthy patients.

Friday, May 16, 2025

Fecal immunochemical testing for colorectal cancer is effective and cost-effective

The U.S. is one of only a few countries in the world that relies on colonoscopy as a primary method of screening for colorectal cancer (rather than reserving it for the evaluation of people who test positive on stool-based screenings). I recently wrote a commentary in Medscape about new evidence that supports a continued role for fecal immunochemical testing (FIT) as a colorectal cancer screening test. My article concluded:

When reviewing colorectal cancer screening test choices with patients, family physicians can continue to recommend annual or biennial FIT as a comparable option to colonoscopy. If FIT is selected, we should provide a kit with liquid vial sample collection, if possible, and include a suggested return date in patient instructions. Finally, clinicians in leadership and population health management roles should advocate for cost-effective investments in patient navigation to enhance colorectal cancer screening and diagnostic colonoscopy completion rates, because these initiatives play a crucial role in preventing colorectal cancer deaths.

Exact Sciences, which sells a $600 stool-based screening test that combines FIT with a test for colorectal cancer DNA, would like physicians and patients to believe that its test ("Cologuard") provides superior value to practices and health systems than FIT alone. But an analysis published this week in the Annals of Internal Medicine indicates that it does not. Using data from the original Cologuard diagnostic performance study and a study of a second-generation version (Cologuard Plus), Dr. Hermann Brenner and colleagues at Heidelberg University in German showed that the cost per colorectal cancer detected is 7- to 9-fold higher for Cologuard and Cologuard Plus compared to FIT, depending on what percentage of patients undergo colonoscopy after a positive test result.

Sunday, May 11, 2025

Identifying and managing gambling-related harms

The Supreme Court under Chief Justice John Roberts (the Roberts Court) has made several high-profile rulings affecting health care over the past two decades, including its 2012 decision that upheld the Affordable Care Act’s Medicaid expansion but made it optional for states and its 2022 decision that abortion was not a fundamental right protected by the US Constitution.

A less heralded ruling with health implications occurred in 2018, when the Roberts Court held that a prior federal law forbidding states to legalize sports betting was unconstitutional. This decision led to the rapid proliferation of online sports gambling platforms and their ubiquitous television advertisements. No longer do people need to travel to brick and mortar casinos to place bets on players or teams; now they can legally win and lose large sums through a variety of smartphone apps. 68 million Americans, or one in four adults, planned to wager an estimated $15.5 billion on the NCAA Division I basketball tournaments (March Madness) this year.

Expanded access to sports gambling has fueled a rise in the number of people affected by gambling disorder. Previously known as pathologic gambling, gambling disorder manifests as “impaired control over gambling, gambling taking precedence over other life interests, and the continuation or escalation of gambling despite negative consequences.” Young males are the demographic group most likely to have gambling disorder, and comorbid alcohol use disorder and depression are common. Although prevalence estimates in North America are low (1.5% of women, 2.7% of men), hazardous gambling—risky or compulsive gambling behavior that does not meet criteria for gambling disorder—is thought to be far more common, particularly in older adults with more leisure time.

A recent article in the BMJ summarized a National Institute for Health and Care Excellence (NICE) guideline on identification and management of gambling-related harms. Based on expert opinion and low-certainty evidence, NICE recommends that clinicians ask direct questions about gambling in patients with mental health concerns, alcohol or substance use disorders, housing or financial insecurity, justice involvement, and certain higher-risk professions (eg, active-duty military, veterans, sports professionals, people working in the gambling or financial industries). People with gambling disorder are at increased risk for self-harm and suicide attempts. Effective treatments include referral to self-help groups such as Gamblers Anonymous, group or individual cognitive behavioral therapy, motivational interviewing, and naltrexone. Psychology Today maintains a national directory of therapists with training in CBT for gambling disorder.

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This post first appeared on the AFP Community Blog.

Thursday, May 1, 2025

Migraine headaches: diagnostic and treatment tips

A patient with a history of headaches is brought by ambulance to the emergency department for the abrupt onset of weakness and decreased sensation in their left arm and leg. A code stroke is called. Are these symptoms of an acute stroke or a stroke mimic, such as a hemiplegic migraine?

A retrospective analysis of characteristics of 15 consecutive years of code stroke cases at a hospital in Barcelona, Spain, found that patients who were ultimately diagnosed with migraine headache with aura (1.1%) were more likely to be younger, female, and have fewer vascular risk factors than patients with ischemic strokes. In addition, an initial NIH Stroke Scale of greater than 6 (odds ratio = 3.74) and a fibrinogen level of greater than 400 mg/dL (odds ratio = 2.98) distinguished strokes from migraine headaches.

An article on acute migraine headaches in the April 2025 issue of American Family Physician reviewed current treatment strategies for acute migraine headaches, which “account for … 3.6 million primary care visits annually and are the fifth most common reason for emergency department visits” in the United States. The POUND mnemonic (ie, pulsatile quality, one-day duration, unilateral headache, nausea or vomiting, disabling intensity) can help clinicians make the diagnosis of migraine in primary care, and the Migraine Disability Assessment (MIDAS) quantifies headache severity. Scores that indicate MIDAS grades III and IV should prompt clinicians to consider targeted migraine medications rather than simple analgesics.

Although several drug classes are effective for acute migraine, a 2024 systematic review and network meta-analysis of 137 randomized controlled trials (summarized in a POEM in the April 2025 issue of AFP) found that triptans produced greater pain relief at 2 hours and less use of rescue drugs in the first 2 to 24 hours than the newer and more expensive medications ubrogepant, rimegepant, and lasmiditan.

Clinical practice guidelines on the management of episodic migraine headache, including the 2023 US Veterans Affairs/Department of Defense guideline, preferentially recommend triptans for most patients. In March, the American College of Physicians released a pharmacologic treatment guideline that recommends adding a triptan in nonpregnant adults with moderate to severe migraines who have not responded to a nonsteroidal anti-inflammatory drug or acetaminophen. Triptans can cause vasospasm, so they are contraindicated in patients with coronary artery disease, cardiovascular disease, and peripheral artery disease and should not be used in combination with ergot alkaloids.

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This post first appeared on the AFP Community Blog.

Friday, April 25, 2025

For family medicine workforce, HHS reorganization plan receives a failing grade

Match Day on March 21, 2025 unfolded similarly to the National Resident Matching Program in previous years. My program successfully recruited a full class of 13 future interns from medical schools across the country, but family medicine as a whole, despite the typically rosy American Academy of Family Physicians news story, didn't even come close, with 15% of slots unfilled and a quarter of programs needing to enter the Supplemental Offer and Acceptance Program (SOAP, previously known as the "Scramble"). The sub-headline from a Medscape news article said it all: "Anesthesiology Still Hot, Family Medicine Is Not."

Before becoming a core faculty member at the Lancaster General Hospital Family Medicine Residency Program, I spent more than 15 years teaching in Georgetown's family medicine department. Part of my job was to encourage students' interest in primary care careers and mentor those who chose to enter family medicine. Out of a typical graduating class of 200 students, our largest family-medicine bound group was 15 (7.5%) and the smallest was 6 (3%). Most years, two or three times as many students matched into Anesthesiology or Orthopedic Surgery.

While I'm grateful for subspecialists who alleviate pain, rescue patients who are unable to breathe on their own, manage complicated fractures, and replace worn-out hips and knees, the gap between the number of family doctors we need and the number we have keeps getting wider. The number of visits to primary care physicians fell by 43% from 2010 to 2021 despite 7.4% growth in the U.S. population, and a near-doubling in outpatient visits to advanced practice providers (the majority of whom work in medical subspecialties) wasn't enough to make up for this deficit. Challenges in accessing timely primary care affect not only private practices and health systems, but also the publicly funded Veterans Affairs system.

How can we train more family physicians? A recent study in Family Medicine found that contrary to conventional wisdom, more graduating students switch in to family medicine from another specialty than switch out of it after intending on family medicine upon matriculation. (I'm an example of this pattern, having intended to become a pediatrician when I started medical school.) Although this doesn't diminish the importance of nurturing students who (like my wife) declare their interest in family medicine starting on day one, it seems to make representation on admissions committees less critical. Other proposals include streamlining pathways for international medical graduates to enter residency programs in fields with physician shortages.

A report funded by the Milbank Memorial Fund highlighted five states - Virginia, Rhode Island, Connecticut, Oklahoma, and California - that are or will be setting spending targets for primary care as a percentage of their overall health care spend in order to increase their supply of clinicians and give practices more of the resources they need to improve health outcomes. This is, to put it mildly, easier said than done, starting with how to define primary care, estimate the health care dollars flowing into it, and determine the optimal percentage of those dollars. And if you build it, will they come?

We can hope and pray that some combination of interventions in premed programs, medical school, residency, and financial compensation will build the primary care infrastructure that America needs and prevent our health outcomes from getting much worse than they already are. But we need more research to design and implement these efforts. Dr. Rochelle Walensky, who directed the Centers for Disease Control and Prevention (CDC) from 2021 to 2023, calls the current state of affairs an "evidence emergency":

There is no more urgent research need than addressing the health of the workforce that is charged primarily with caring for the people of its nation. And yet, there is neither a funding stream nor a cohesive research community to do so. An investment in the evaluation of initiatives to strengthen the physician workforce is critical, and such research should not be conducted in silos. Data must be shared and evidence compiled and then directly interpreted and acted on for program and policy decision making.

Foundations such as Milbank, the Kaiser Family Foundation, and the Commonwealth Fund can't support this work by themselves. This is where the federal government must step up. But the Trump administration's radical shrinking and restructuring of the Department of Health and Human Services (HHS), which decimated the workforces and research grant-issuing functions of the better-known National Institutes of Health and the CDC, has also vanished the agency responsible for supporting health services research. According to HHS, the Agency for Healthcare Research and Quality will be merged into an "Office of Strategy," and the Health Services and Resources Administration (HRSA), which supports the backbone of federally qualified health centers that provide primary care to 1 in 11 Americans, will be consolidated into RFK Jr.'s "Administration for a Healthy America." To use a professional football analogy, it's as if the general manager of the team with the league's worst record used their premium draft picks to select a bunch of recreational players who wouldn't have been drafted by any other team in the first place. Instant analysis: a failing grade for HHS.

Saturday, April 12, 2025

What's new in osteoporosis screening and fracture prevention?

In the two years since publication of the latest American Family Physician review article on osteoporosis, new guidelines and research studies have enhanced management of this common condition. In early 2025, the U.S. Preventive Services Task Force (USPSTF) updated its recommendations on screening for osteoporosis. Although on the surface these are unchanged from the 2018 version—recommending screening in all women 65 years or older and postmenopausal women younger than 65 years at increased risk for an osteoporotic fracture and finding insufficient evidence to screen men—an accompanying editorial noted a small, but significant, difference.

Previously, the USPSTF defined increased risk by a threshold on the Fracture Risk Assessment Tool (FRAX) that corresponded to the 10-year fracture risk of an average 65-year-old White woman. However, evidence indicates that the predictive value of FRAX without bone mineral density is poor and inferior to simpler tools such as the Osteoporosis Self-Assessment Tool and the Osteoporosis Risk Assessment Instrument. In its updated recommendations, the USPSTF recommends only a “clinical risk assessment” and notes that if FRAX is used, it “does not intend that these 10-year risk levels be used as mechanistic thresholds” to decide who should undergo dual-energy absorptiometry screening.

A recent analysis of the performance of the Osteoporosis Self-Assessment Tool, Osteoporosis Risk Assessment Instrument, and the Osteoporosis Assessment of Risk tools in a subgroup of Women’s Health Initiative participants 50 to 64 years of age found that each had “fair to moderate discrimination” in identifying osteoporosis, with areas under the receiver operating characteristic curve of 0.633 to 0.663, with 1.0 being perfect and 0.5 being no better than chance.

Not only is it difficult to clinically predict osteoporosis risk, fragility fractures can occur in patients without osteoporosis. In January 2025, researchers published a randomized, placebo-controlled trial of an alternative strategy for reducing fractures: treating women in early menopause with antiresorptive therapy regardless of bone mineral density. There were 1,054 women 50 to 60 years of age with bone mineral density T-scores at the lumbar spine or hip from 0 to -2.5 at baseline assigned to one of three groups: zoledronate intravenous infusion at baseline and repeated at 5 years; zoledronate infusion at baseline, placebo at 5 years; and placebo infusions at baseline and at 5 years. After 10 years, new fractures had occurred in 11.1% of the placebo-placebo group, 6.6% of the zoledronate-placebo group, and 6.3% of the two dose zoledronate group. The relative risk of fractures in the two-dose zoledronate compared with the placebo-placebo group was 0.72, with a number needed to treat of 25 to prevent one fracture. The comparative benefits and cost effectiveness of this prevention strategy vs fracture risk assessment and treating women at increased risk remains to be seen.

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This post first appeared on the AFP Community Blog.

Wednesday, April 2, 2025

What's in a name?

The following is a guest post from my sister-in-law, Dr. Therese Duane, a trauma surgeon who is on a medical mission in Uganda. You can read more about the essential work she and her colleagues have been doing at Mercy Trips Healthcare Outreach.

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Taking poetic license from Shakespeare, I recently found myself contemplating the value attributed to names and titles as I prepared for my next mission trip. For so long, my focus had been achieving more of these—whether it be professor of surgery, program director, or chair of the department. Fortunately, in His goodness, God stripped them away and left me with what really mattered—the names of wife, mother, sister, daughter, aunt, niece, friend, Godmother and now Mom Mom.
#Perspective #LegacyOverLabels #AmericanCollegeofSurgeons

In my family, Mom Mom is the sobriquet of the matriarch instead of grandmother. It has always represented the woman in the generation whose strength kept the family together. I grew up in awe of my Mom Mom, my mother’s mom, who as the mother of eight, built a newspaper alongside my Pop Pop while raising diligent and devout children. My mother, my children’s Mom Mom, followed in her footsteps embodying the same fortitude. With my Dad, she raised seven children who learned determination and discipline through tough love at an early age. So, when our eldest daughter Alejandra—who joined our family 17 years ago as our au pair and quickly became our 5th child—had her first, I could not be prouder to strive to deserve the name of Mom Mom.
#BlendedFamily #ChosenFamily #MomMomMoments

Being Mom Mom began as we walked her pregnancy together with all the anxieties and anticipation culminating in the birth. After 38 hours of labor, multiple positions, four hours of pushing and me supporting her mostly by yelling “GET OUT” to the baby and suggesting things that her wonderful OB/GYN, @JaimeObst, politely told me, “They don’t do that anymore,” baby Bella was born! My own experience in childbirth had been very different—having 4 kids in less total time than it took her to have one—ahh the benefits of being on call the night before giving birth! Hence, Bella’s delivery was transformative for all of us. Ale recognized her inner strength and responsibility as a new mother and me the power and privilege of being a Mom Mom.
#WomensHealth #BirthStory #GenerationalStrength


So what does this have to do with a mission trip? It all has to do with prioritizing the roles we do have. Just one day after getting Ale settled at home, I left to serve the community at IntegrisHealth Baptist as an acute care surgeon for a week, came home for one day and then was off for a four-day band trip with my two youngest as chaperone and band doctor—to fulfill my other name as Mom. Grateful that my professional family supports my flexible work schedule, I can fulfill all my roles. Of course, none of it would be possible without an understanding husband holding down the fort. This wife was able to spend two days in four weeks at home before leaving to fulfill my privileged role as missionary.
#MissionWork #FaithInAction #MedicalMissions #MomLife #GratefulHeart

So perhaps Shakespeare had it right. The name or title does not matter in and of itself—what is more important is how you fulfill the role. Becoming a missionary has made me appreciate so much more all the titles I have that really matter, none of which include monetary value and yet are invaluable to the people they bless and to the God who made me for the purpose. In Uganda, I see women labor with no pain medicine and pushing through it with a stoicism that is humbling. I am grateful for what we have in the US and for the care my daughter and granddaughter received. Moreover, as a mother and now as a Mom Mom trying to emulate those who came before me by setting the example of unconditional support, I know my family are in the good hands of each other and more importantly of God.
#GlobalHealth #ServingOthers #MercyInAction #Gratitude #PurposeDriven


Hence, I had no qualms returning soon after Bella’s birth to the country where these strong people survive under harsh circumstances to do what I can to help them. Ultimately, as I have learned through this missionary work with Mercy Trips, kindness, compassion and generosity fulfill the ideals of the most important name of all which we each should embrace—Child of God.

#MomMom #LegacyOfLove #FaithFamilyMission #LivingYourPurpose

Friday, March 28, 2025

Measles, vaccine hesitancy, and the ACIP

As of March 27, 2025, 19 states had confirmed a total of 483 measles infections, with 444 cases associated with an ongoing outbreak in West Texas and New Mexico that began in late January. 70 people (14%) have been hospitalized for serious illnesses, and one child and one adult have died. For comparison, there were 285 cases of measles in the United States in 2024, and there have already been more reported cases than in all but two years since 2000. In a 2024 American Family Physician editorial, Dr. Doug Campos-Outcalt reviewed best practices for diagnosis and prevention of measles. Of note, “a person with measles is infectious 4 days before through 4 days after the appearance of the [erythematous, maculopapular] rash.”

Increasing vaccine hesitancy has depressed measles, mumps, and rubella (MMR) vaccination rates in the affected jurisdictions, making more people vulnerable to the highly contagious illness. Parents may refuse vaccinations for their children due to concerns about adverse effects, such as the repeatedly debunked myth that MMR increases the risk of autism. (Studies show a 4 in 10,000 risk of a febrile seizure after receiving MMR at 12 to 15 months of age, considerably lower than the risk associated with measles infection.) Although the American Academy of Family Physicians and the American Academy of Pediatrics discourage nonmedical exemptions from childhood immunizations required for daycare or school attendance, “philosophical” or religious exemption policies have been increasing in the United States. In West Virginia, where the last reported case of measles was in 2009, physician advocacy groups successfully petitioned the governor to veto a 2024 bill passed by the state legislature that would have allowed private and parochial schools to opt out of state immunization requirements.

Currently, infants 6 to 11 months of age are recommended to receive an early MMR dose before international travel. In a recent JAMA Viewpoint, former Centers for Disease Control and Prevention (CDC) director Rochelle Walensky, MD, MPH, and colleagues proposed “updating the existing recommendation for an additional early MMR dose to infants aged 6 to 11 months traveling to any region with increased probability of measles exposure, whether international or domestic.” Although several federal agencies play a role in vaccine development and use, the CDC’s Advisory Committee on Immunization Practices (ACIP) has been the authoritative source of vaccine recommendations since its formation in 1964. Members of this independent committee are required to disclose financial conflicts of interest and recuse themselves from deliberations and votes about a vaccine, its potential competitors, and any other products of the company that makes the vaccine. An investigation by the journal Science concluded that contrary to accusations by leaders of antivaccine groups such as Robert F. Kennedy, Jr., there was “no sign that [ACIP] vaccine advisors are beholden to industry.” After the ACIP’s February 2025 meeting was postponed for unclear reasons, the CDC has announced that the committee will meet next month. According to the Federal Register notice, the agenda includes recommendation votes on meningococcal vaccines, chikungunya vaccines, and RSV vaccines for adults, as well as “an update on the current [Texas/New Mexico] measles outbreak.”

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This post first appeared on the AFP Community Blog. More than 100 new measles cases have been reported in the U.S. since last week.

Sunday, March 23, 2025

Once again, the Agency for Healthcare Research and Quality is in the line of fire

This post first appeared on March 6, 2018, during the first Trump administration's failed attempt to eliminate the Agency for Healthcare Research and Quality (AHRQ). Now the Department of Government Efficiency is trying again, threatening 90% staff reductions that would decimate the agency. Please join me and hundreds of medical organizations in standing with AHRQ and preserving its vital contributions to the health of all Americans.

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For the past 30 years, a little-known U.S. health agency has supported and produced volumes of groundbreaking research on how to make health care safer, less wasteful, and more effective. Dubbed "the little federal agency that could," AHRQ has accomplished this feat with a small fraction of the budgets of its higher-profile cousins, the Centers for Disease Control and Prevention and the National Institutes of Health. Nonetheless, its work has often been politically unpopular and unheralded outside of a small community of health services researchers and patient advocates. Sadly, when all medical waste is somebody's income, there is little enthusiasm in the medical-industrial complex or on Capitol Hill in allocating the $3 trillion the U.S. spends on health care more wisely or efficiently. In fact, our legislative and executive branches have periodically proposed that AHRQ's budget be slashed or eliminated entirely.

In 1994, the agency (then known as the Agency for Health Care Policy and Research) dared to publish a back pain guideline that suggested that there was little role for surgery in most patients. As later documented in Health Affairs, this act raised the hackles of back surgeons with powerful allies in Congress who were already annoyed by the agency's association with the failed Clinton health reform plan. The agency's budget was zeroed out by the House of Representatives and narrowly restored by the Senate in 1995 after a 21 percent cut and a name change to emphasize that its mission would be to produce evidence to inform policy, rather than attempt to actively shape policy.

Despite this deliberately circumscribed mandate (I lost count of the number of times during my tenure as an AHRQ medical officer from 2006-2010 that I was told, "We don't make guidelines. We make evidence that other groups use to make guidelines"), the passage of the Affordable Care Act made AHRQ a target again in 2012, when a House appropriations subcommittee voted to zero out its budget again. AHRQ survived that episode, only to be zeroed out by the House once again in 2015, when the danger to the agency's survival seemed real enough that former Senate majority leader Bill Frist and former CMS director Gail Wilensky both penned op-eds urging their Republican colleagues to reconsider - which they eventually did.

Ironically, the need for AHRQ's work has never been greater. The proliferation of clinical practice guidelines of varying quality and conflicting recommendations has led to calls to systematically evaluate guidelines for their impact on patient outcomes. AHRQ would be a natural place for this evaluation to occur, as its National Guideline Clearinghouse already summarizes and synthesizes guidelines that meet certain evidence-based development criteria. But funding to maintain the NGC will run out a little more than 4 months from now, and there seems to be little hope of rescue. [Update: the NGC ceased operating in 2018.]

In the meantime, the Trump Administration has proposed dissolving AHRQ as an independent agency in the next fiscal year and transferring its current functions into a new institute within the NIH, with a 21 percent budget cut from 2017. Although such an arrangement has both potential pros and cons, as a previous AHRQ director observed, it's hard to imagine that the shrunken agency would not be marginalized and lost amid NIH's biomedical research behemoth.

Why do I care? Why should you? You need not be ill enough to be hospitalized or care about practice guidelines to suffer if AHRQ is eliminated for good. Not only does it produce several important tools and resources for primary care practice, but it disseminates and implements evidence about what works to improve health, through its National Center for Excellence in Primary Care Research. AHRQ supports research that generates evidence about "effective models of care, patient- and family-centered care, shared decision making, quality improvement, and health information technology." This is research and evidence that no one, healthy or ill, can afford to lose. Academy Health maintains an advocacy toolkit for use by any person or organization who wants to help #SaveAHRQ from becoming a casualty of ignorance, indifference, and/or conflicts of interest. I hope that I have persuaded you to join the fight.

Tuesday, March 18, 2025

Book Review: Has Medicine Lost Its Mind? by Dr. Robert C. Smith

The COVID-19 pandemic and the isolation caused by public health measures to slow its spread exacerbated a mismatch between the need for mental health care and the number of professionals trained to provide that care. Even though stigma prevents many persons with mental health problems from seeking care, there has never been enough go around. In Has Medicine Lost Its Mind? Why Our Mental Health System is Failing Us and What Should Be Done to Cure It, Dr. Robert C. Smith, a general internist and professor of medicine and psychiatry at Michigan State University, explains why our medical system consistently prioritizes physical over emotional health and presents some ambitious proposals for how to rectify this harmful disparity.

This relatively slim volume is divided into three parts. The first few chapters discuss the problems with mental health care in the U.S. and the suffering that they cause. Dr. Smith shares the stories of several patients he met during residency and his early years in practice who illustrate the bad outcomes that accompany not attending to patient's emotions and focusing solely on their physical problems. These experiences motivated him to complete a two-year fellowship in behavioral health and psychiatry, where he learned the biopsychosocial model and decided to make primary care mental health the teaching focus of his academic career. Dr. Smith notes that less than 5 percent of the preclinical and clinical curricula in medical school, absent electives, is devoted to teaching students about behavioral health or psychiatry. Thus, he argues, physicians were ill-prepared to confront the opioid epidemic, increasing rates of depression and anxiety in conjunction with chronic illness, and the negative effects of COVID-19 on mental health. 

The second part of the book traces the history of the "mind-body split" in medicine, starting with Hippocrates, through the Flexner Report (1910) to the present day. In contrast, he presents the infrequently taught patient-centered interview as a paradigm shift (a la Thomas Kuhn) with the potential to revolutionize medicine. In the concluding chapters, Dr. Smith proposes a pathway to redirect the medical-industrial complex "back to a more humanistic orientation," which involves commissioning a "New Flexner Report" and federally-led reforms to medical education to require schools to fully embrace the biopsychosocial model. Primary care medical and residency faculty will learn the principles of mental health care via a train-the-trainer approach.

Although I dispute Dr. Smith's assertion that primary care physicians receive next to no training in mental health care (though I can only speak to my specialty of family medicine), I agree that structure of our health system discourages meaningful doctor-patient interactions, and that the assembly-line mentality of traditional primary care practice incentivizes drug prescribing over active listening. Medicine could do a far better job of diagnosing and treating mental health conditions, but absent a robust public health structure, their root causes - worsening economic and political inequality, a deteriorating environment, and a weak social safety net - will remain. And having the federal government or the Association of American Medical Colleges (AAMC) lead a national effort to dramatically expand the footprint of behavioral health in medical education is likely a pipe dream. This is not to say that this book is not worth reading - far from it. But I fear that it is too far ahead of its time.

Saturday, March 15, 2025

"Sludge audits" identify obstacles to completing colorectal cancer screening

In a traditional health care setting, many administrative burdens and barriers stand in the way of patients receiving evidence-based care. Paperwork required to sign up for health insurance and to establish care with a practice. Calling to schedule the next available appointment and taking time off work. Travel to the doctor’s office. Wait times. More travel to a laboratory or a different office for a test or procedure. Remembering to eat or not eat, or what to eat, before being tested. The list goes on.

A 2022 article in the Harvard Business Review introduced the term sludge to describe “these types of situations in which the design of a specific process consistently impedes individuals from completing their intended action.” A sludge audit is “a systematic approach to identifying the presence and cost of sludge and figuring out how to eliminate it.” Although not originally applied to health care processes, sludge audits can improve the efficiency of health systems and patients’ experiences. The article identified four approaches to reduce sludge: (1) reduce the number of steps, (2) add a digital option, (3) remove roadblocks, (4) offer virtual alternatives to in-person processes.

Dr. Michelle Rockwell and colleagues at the Carilion Clinic in Roanoke, Virginia, performed a sludge audit of their colorectal cancer (CRC) screening services in 2021 and 2022. They quantified time, paperwork, communication, technology (number of mouse clicks to order a CRC screening test), other administrative tasks, and low-value CRC screenings. They found that clinicians needed a median of 17 mouse clicks to order a screening colonoscopy; the median wait time between primary care referral and scheduling was more than 6 weeks; wait time between scheduling and having the procedure was more than 6 months; some patients were asked to attend multiple preoperative visits; and nearly 1 in 3 follow-up colonoscopies was judged as being performed at a shorter interval than necessary. Finally, neither patients nor primary care clinicians could easily access the results of colonoscopies or stool-based tests.

Unsurprisingly, patients’ experiences with the health system’s CRC screening process were suboptimal; 37% of surveyed patients reported that their tests were delayed or not done because of “excessive or unnecessary paperwork, communication, technology or waiting.” Patients who chose fecal immunochemical tests needed to visit another location to pick up test kits, and some stated that they could not understand the instructions with the tests. Patients with Medicaid insurance or dual Medicare-Medicare coverage were more likely than those with private insurance to report sludge. In contrast, patients who reported no or minimal sludge were more likely to complete screenings and less likely to report distrust in the health system.

Even in a population where everyone has the same health insurance, having more social needs is associated with lower CRC screening rates. A cross-sectional study of Kaiser Permanente patients ages 50 to 75 years who completed a social needs survey in 2020 found that those who reported severe financial strain, severe social isolation, and severe food insecurity were statistically twice as likely to not be up to date on CRC screening than other patients.

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This post first appeared on the AFP Community Blog.

Friday, February 28, 2025

Is there enough time for prevention in primary care?

Family physicians are being squeezed by two accelerating trends: (1) too few of us to care for the growing US population and (2) the rising number of tasks that we are asked to accomplish for each patient. A 2024 analysis projected that by 2040 a shortage of 58,000 primary care clinicians (including nurse practitioners and physician assistants) will occur. Meanwhile, the estimated time needed to provide guideline-recommended preventive care, chronic disease care, and acute care to a nationally representative panel of 2,500 adult patients is an impossible 26.7 hours per day, with more than one-half of that time (14.1 hours) allocated to preventive care.

As science advances, the number of US Preventive Services Task Force (USPSTF) A and B graded recommendations grows, and the size of the affected populations expands. Since 2020, the starting ages for breast, lung, and colorectal cancer screening were lowered to 40, 50, and 45 years, respectively. The USPSTF also has endorsed screening most adults for anxiety disorders and unhealthy drug use. In an editorial in the February 2025 issue of American Family Physician, Dr. Mark Ebell and I discussed concerns about the quality of the evidence for several recommendations. "To justify the extra time and effort associated with implementing new or expanded screening recommendations," we cautioned, "clinicians must have confidence in the reliability of USPSTF assessments regardless of the task force’s membership at any point in time."

A 2025 commentary in the BMJ proposed a radically different solution to the workforce crisis: Take prevention for low-risk patients off the plate of primary care. The authors noted that as measured by the number of patients needed to treat to prevent one negative outcome, “care for symptomatic patients provides substantially greater benefit than preventive care.” Rather than counseling patients individually to quit smoking, drink less alcohol and sugar-sweetened beverages, and consume fewer highly processed foods, medicine should defer prevention to public policy measures (eg, taxes on cigarettes and laws restricting where people can smoke) that achieve these goals more effectively. Not only would this approach free time for family physicians to focus on patients with acute complaints and chronic diseases, the authors argued, but it would also remove the “ethical stress” that comes with “the mismatch between the patient’s needs and the burden of preventive care” in the form of quality metrics.

The problem with this proposal is that in the United States, the public health workforce is not positioned to handle routine screenings and immunizations. This month, the Centers for Disease Control and Prevention (CDC), the federal agency sponsor of the USPSTF’s sister panel, the Community Preventive Services Task Force (CPSTF), was forced to lay off 10% of its work force. Portions of the CPSTF’s website, including the biographies of its current members, are still missing after thousands of CDC web pages were abruptly removed or altered. There may not be enough time for prevention in primary care, but family physicians need to keep providing it the best we can.

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This post first appeared on the AFP Community Blog.

Friday, February 21, 2025

Book Review: Booster Shots by Dr. Adam Ratner

In two decades of practicing family medicine, I've never seen a patient with measles. But if there was ever a more fertile environment for this age-old contagion to come roaring back in the U.S., this is it. As a measles outbreak in West Texas approaches 100 cases and the national percentage of kindergarten-age children who have received measles, mumps, and rubella (MMR) vaccine has fallen below 93%, vaccine conspiracy theory amplifier Robert F. Kennedy, Jr. has taken the reins as Secretary of Health and Human Services (HHS). In his first week on the job, Kennedy declared his intention to re-evaluate the entire recommended vaccine schedule and indefinitely postponed next week's meeting of the CDC's Advisory Commission on Immunization Practices, which creates the schedule and had been holding uninterrupted meetings to provide guidance for clinicians for the past 60 years. (Oh, and the CDC's National Immunization Survey has been canceled by the so-called Department of Government Efficiency, even if the Epidemic Intelligence Service seems to have received a temporary reprieve.)


This real-life scenario is probably Dr. Adam Ratner's worst nightmare, but it couldn't have come at a better time for his book. Ratner, a pediatric infectious diseases specialist at NYU Grossman School of Medicine, wrote Booster Shots: The Urgent Lessons of Measles and the Uncertain Future of Children's Health to retrace the history of human interactions with measles and explain why our mastery of the science of vaccination hasn't led to enduring eradication of this highly transmissible, damaging, and occasionally lethal infection. In the introduction, Ratner conveys the fury of two grandparents at their adult daughter for refusing measles vaccination for their granddaughter, who becomes one of the first of hundreds of New York City children to be hospitalized for measles in a 2018-19 outbreak:

What happened between those two generations, the vaccine-hesitant mother and her own parents, dumbstruck at the idea of someone opting out of the miracle of vaccination? How did we go from eliminating measles in the United States ... to a massive resurgence in 2019, presaged by smaller blips in the prior years? And should those blips have warned us about some of the problems that we would face with the COVID-19 pandemic - the vaccine hesitancy, the demands for unproven (and sometimes rigorously and scientifically disproven) medications, the distrust of doctors and public health professionals, the underestimation of the new virus's effect on children?

Ratner does an exceptional job describing the epidemiology and virology of measles without watering down the science for a general audience, and the fascinating narrative of the history of measles epidemics over the centuries left me wondering if he had a master's degree in history rather than public health. The most impactful chapters, though, are "Making Nothing Happen," about the laboratory breakthroughs that led to the licensing of the first measles vaccines; and "Amnesia," which juxtaposes the immune system amnesia that often results from measles infection and the human amnesia that causes declines in cases to make people forget why it's necessary to protect children and adults against measles in the first place.

In the concluding chapter, written long before Kennedy was nominated or confirmed as HHS Secretary, Ratner emphasizes the importance of confronting him and other purveyors of vaccine misinformation with the same resolve and attention to detail that have produced the unrivaled medical success of the routine childhood immunization schedule: preventing 508 million cases of illness, 32 million hospitalizations, and 1,129,000 deaths in the U.S. over the past 30 years. This is the perfect book for a very imperfect era, when the future health of our nation very much hangs in the balance. Fortified by Booster Shots, champions of prevention will be able to stand their ground.

Saturday, February 15, 2025

Direct-to-consumer advertising distorts prescription drugs’ benefits and costs

In 1998, a Letter to the Editor in American Family Physician expressed concerns about the relatively new practice of pharmaceutical advertising directly to patients. Dr. Robert Thompson observed that the effect of direct-to-consumer advertising (DTCA) was to consume precious time at an office visit by prompting patients to request expensive new “me too” therapies that often were not on their drug formularies. He argued that "the pharmaceutical industry should concentrate its efforts on educating physicians about its new products, not coercing patients to put pressure on physicians to make decisions that may not be necessary, beneficial or cost-effective."

A quarter of a century later, the United States remains the only country besides New Zealand where DTCA for prescription drugs is completely legal. In November 2024, a new U.S. Food and Drug Administration (FDA) rule went into effect requiring television and radio advertisements for drugs to communicate risk and contraindications in a “clear, conspicuous, and neutral manner.” On the surface, this rule aligns with the American Academy of Family Physicians’ policy that information provided in DTCA "should be accurate, balanced, objective, and complete, not false or misleading, and should not promote unhealthy or unsafe practices."

But a recent perspective in the American Journal of Preventive Medicine pointed out that the rule is silent about advertisements on online and social media platforms. It also does not change the context that most patients overestimate drug safety and that the most heavily advertised drugs have lower added benefit compared with similar medications.

To take one example, a television ad for the moderate-to-severe plaque psoriasis drug risankizumab (Skyrizi) was ubiquitous during the just-concluded National Football League regular season and playoffs. On Sensible Medicine, Dr. Edward Livingston pointed out that the manufacturer, AbbVie, spent $580 million on DTCA for this drug in 2023, or $290 for each of the 2 million potential patients in the United States. The annual price of risankizumab is $288,000, so this is still a huge bargain for the company given the potential returns. Dr. Livingston explained that the ad misleads viewers about the indication and cost of risankizumab:

It shows a psoriatic lesion involving less than 1% of body surface area (BSA). Drugs like risankizumab are only indicated for moderate (3-10% BSA) or severe (>10% BSA) plaque psoriasis. Viewers of the ad might believe this drug can be used to treat small, isolated lesions. They will be influenced by the visuals and are not likely to understand that risankizumab should only be used for more severe disease than is shown in the ad.… The ad states that patients may pay as little as $5 per dose, 4 times per year.… The price on the website is even better: $0 per dose. Who could blame a patient for believing the drug doesn’t cost much. If it did, why give it for free? But it is not free. Rather it is one of the most expensive psoriasis treatments available. Who pays? All of us.

A 2023 commentary in BMJ Evidence-Based Medicine contended that DTCA may "encourage patients to self-diagnose or to misinterpret their symptoms, contributing to often unnecessary diagnostic testing and the twin risks of overdiagnosis and overtreatment."

Potential reforms short of making DTCA illegal in the United States include legislation requiring manufacturers to include drug prices in ads and Secretary of Health and Human Services Robert F. Kennedy, Jr.’s previously stated intention to ban DTCA from television. However, the DTCA bill has repeatedly died in every Congress since 2019, and executive action on DTCA would almost certainly prompt a First Amendment court challenge by pharmaceutical companies.

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This post first appeared on the AFP Community Blog.

Saturday, February 1, 2025

Does transitional care management improve outcomes after discharge from the hospital?

I've spent the past week as the attending physician on my residency program's adult inpatient service. Since the turn of the century, the rise of hospitalists and the corresponding decline in the number of office-based family physicians who provide inpatient care for their own patients has magnified the value of optimizing the handoff from hospital-based teams to primary care physicians. Chronic conditions that frequently lead to readmissions, such as heart failure, have been targets of transitional care interventions that may include self-care education, home visits, telephone contacts, and office visits. A 2014 Agency for Healthcare Research and Quality review found consistent evidence that high-intensity, multicomponent interventions for patients with heart failure reduced readmissions and mortality for 3 to 6 months after hospital discharge.

Recognizing their potential to save money and improve outcomes, in 2013 the Centers for Medicare and Medicaid Services began allowing practices to bill separately for transitional care management (TCM) services that included an interactive contact within two business days of discharge and a dedicated face-to-face office visit within 14 days. Practices developed novel workflows to support TCM and to ensure that it is financially sustainable, as reviewed in a 2023 article in FPM. Although use of TCM has gradually increased, some have expressed concern that these billing codes were not supporting primary care as expected, with one-fifth of Medicare TCM claims being billed by a practice that was not the patient’s primary care practice. A recent study found that TCM was less likely to be delivered to Medicare patients at the highest risk of readmission:

Racial and ethnic minority status, dual [Medicare and Medicaid] eligibility, dementia, and frailty were common among patients at high risk for readmission as well as those who were less likely to receive TCM service. These findings suggest that poor socioeconomic status and impaired functional status may act as factors for readmission as well as barriers to TCM access.

More than a decade into the program, it remains uncertain whether TCM actually improves outcomes. An analysis of Medicare data from 2012 to 2017 found that "using TCM codes was linked to a modest reduction in the number of patients readmitted to the hospital within 30 and 90 days after discharge, with the greatest improvements seen in 2017. However, we did not observe a significant association with patient deaths after discharge overall."

Also, a systematic review and meta-analysis of 13 studies (including 11 randomized trials) published since 2012 found that post-discharge contacts (mostly telephone calls) within 7 days of discharge had no effects on 30-day emergency department use or hospital readmissions compared with usual care.

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This post first appeared on the AFP Community Blog.

Wednesday, January 22, 2025

Can food policy changes make America healthy again?

Shortly after Donald Trump because the only politician since Grover Cleveland to be re-elected to a non-consecutive second Presidential term, I discussed why Robert F. Kennedy, Jr.'s conspiracy-fueled positions on childhood vaccines and fluoridated drinking water make him unqualified to be the next Secretary of Health and Human Services (HHS). Now that the newly inaugurated President has withdrawn the U.S. from the World Health Organization, presumably paving the way for RFK Jr., if confirmed as HHS Secretary, to "go wild on health," it's time to examine the other side of "Make America Healthy Again": his more mainstream belief that overconsumption of ultra-processed food is the cause of a wide spectrum of chronic health problems.

A side note: medical historians have pointed out that the "again" part of the MAHA slogan, harkening back to a time in the past when our country was healthier than it is today, is nonsensical, as in no past era have Americans lived longer or had a better quality of life with less disability than today. The 19th century, for example?

It’s true that agriculture at the time was organic, food was locally produced and there were no ultraprocessed foods. But fresh fruits and vegetables were in short supply because they were difficult to ship and because growing seasons were so short. ... Common conditions, like hernias, were untreatable — men had hernias as big as grapefruits, held in by trusses. Nineteen percent of those soldiers had heart valve problems by the time they were 60, compared with about 8.5 percent today.

And of course, many thousands of people - mostly young children - died every year from infectious diseases like smallpox, polio, and measles, which have been eradicated or are completely preventable by vaccines that RFK Jr. claims are worse than the diseases. Has he ever seen an iron lung up close? But I digress.

The U.S. government has always had competing interests in food policy. As NYU nutrition professor Marion Nestle (whose engrossing autobiography "Slow Cooked: An Unexpected Life in Food Politics" I read over Christmas break) observed, having the Dietary Guidelines for Americans co-sponsored by HHS and the U.S. Department of Agriculture (whose missions are to help farmers profit from the products they bring to market and to prevent poor people from going hungry by subsidizing food purchases, not to support good health) means that scientifically obvious statements such as "eat less meat" or "drink less alcohol" rarely make it into the guidelines. And opposition from powerful food companies makes even modest changes such as the FDA updating criteria for labeling foods "healthy" and requiring food and beverage products to display amounts of fat, salt, and added sugar at a glance painfully slow.

So what's the evidence that ultra-processed foods lead to obesity and other chronic diseases? A recent systematic review of meta-analyses of observational studies found convincing or highly suggestive links between ultra-processed food exposure and cardiovascular disease, diabetes, anxiety, all-cause and cardiovascular deaths, depression, sleep problems, wheezing, and obesity. Observational studies are susceptible to selection bias, though - perhaps preferring inexpensive highly processed foods is associated with poverty, and poverty itself increases the risk of dying early and unhealthy behaviors, explaining these disease associations.

It's difficult, but not impossible, to randomize study participants to controlled diets; one research team managed to convince 20 adults to participate in a 28-day experiment at the National Institutes of Health that concluded that all other things being equal, people were more likely to consume excess calories and gain more weight on a diet of ultra-processed foods compared to an unprocessed diet. (For further reading, a recent New Yorker article went behind the scenes of this highly cited trial and the debate about its implications that continues to rage in food science circles.)

But the unqualified conclusion "ultra-processed food is less healthy than unprocessed food" is too simplistic, particularly when meat is involved. The plant-based Impossible Burger is clearly ultra-processed, but is it really less healthy than a minimally processed hamburger patty made from ground beef from cows raised on industrial farms? A review of plant-based meat alternatives (PBMAs) in the Canadian Journal of Cardiology found that their nutritional profiles were generally superior to the meats they replaced and improved cardiovascular disease risk factors in dietary trials. The authors concluded that "no currently available evidence suggests that the concerning aspects of PBMAs (food processing and high sodium content) negate the potential cardiovascular benefits."

Which leads me back to RFK Jr.'s crusade against ultra-processed foods. I think implementing this would be an uphill battle because making foods healthier will necessarily require creating more regulations in an administration committed to deregulation. If he's serious about asserting more control over our food production and distribution system to limit ultra-processed foods in the interest of improving Americans' health, RFK Jr. would do well to read Marion Nestle's aspirational agenda for regulating the food industry, which includes actions to take on dietary guidelines, mass media campaigns, taxes, warning labels, marketing restrictions, portion size restrictions, and farm subsidies.