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Tuesday, May 30, 2023

Counseling parents about the leading cause of death in U.S. children: guns

A former colleague of mine maintained throughout his career that the most logical way for family physicians to provide preventive services for adults was to focus on the most common causes of death. Although the top diagnoses leading to death recorded by the Centers for Disease Control and Prevention in 2021 were heart disease, cancer, and COVID-19, that’s not what he meant. Instead, he was speaking of the “actual causes of death,” or the behavioral causes of the causes, which from 1990 to 2017 were tobacco use, poor diets, and physical inactivity. Clinicians can have the largest effect on preventing death in adults by counseling patients to stop smoking, eat healthier foods, and exercise.

What about children and adolescents? All-cause mortality in Americans aged 1 to 19 years has been increasing since 2019, partially due to COVID-19 but mostly from a rise in fatal injuries that began prior to the pandemic. Motor vehicle accidents, which have long been the top cause of death in this age group, were surpassed for the first time in 2020 by homicides and suicides from firearms. Mass shootings in schools and public places attract media attention, but data from the Gun Violence Archive show that these account for a tiny fraction of firearm-related deaths.

In comparison, a 2022 American Academy of Pediatrics policy statement reported that 28 children and young adults through age 24 die from gun violence in the U.S. every day – the equivalent of a typical classroom. A recent Commonwealth Fund report comparing the U.S. to 13 other high-income countries found that Americans are five times more likely to die from being shot than residents of Canada, Switzerland, or France. The report also noted that nonfatal and fatal firearm injuries generate more than $1 billion in initial medical costs each year.

A cross-sectional study of four major cities (New York City, Los Angeles, Chicago, and Philadelphia) found that firearm assaults in children increased substantially during the pandemic, with Black, Hispanic, and Asian children being significantly more likely to experience violence. In March, a nationally representative poll found that 21% of adults have been personally threatened with a gun, 19% have had a family member killed by a gun (including suicide), and 17% have personally witnessed someone being shot. However, only 26% of parents of children under age 18 said that their child’s physician had ever asked them about having guns in the home, and only 5% said that their doctor had discussed gun safety.

A 2020 American Family Physician article on prevention of childhood injury recommended that physicians “ask patients whether there are guns in the home and counsel them about the risk of gun-related injury and about safe storage practices … [and] consider contacting legislators if local gun laws are not in the best interest of children's safety.” A previous editorial that I co-authored with other AFP editors noted that “child-access prevention laws (e.g., safe gun storage) reduce self-inflicted and unintentional firearm deaths and nonfatal injuries among youth, and may reduce unintentional firearm injuries among adults.” By counseling patients in our offices and advocating for legislation to promote firearm safety, family physicians can complement community health initiatives that reduce the risk of gun violence in children. For example, Communities That Care, a prevention program that addresses risk and protective factors for behavioral problems early in life, was recently shown in a randomized trial to reduce the prevalence of handgun carrying in 4400 adolescents living in 24 small towns in 7 states.

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This post first appeared on the AFP Community Blog.

Friday, May 19, 2023

What's the matter with corporate primary care?

I've been meaning to write about this topic for a while, but Dr. Josh Freeman at Medicine and Social Justice beat me to it last week. Josh is a fellow blogger, retired family physician, and Chair emeritus of the Department of Family Medicine at the University of Kansas. His latest post, "Private equity, private profit, Medicare and your health: They are incompatible," explored in depth the negative effects of private equity and for-profit corporations buying up subspecialty and primary care practices, also discussed in a KFF Health News article and in the New York Times. Put simply, the goal of those purchases is to turn a quick profit - often by "upcoding" to charge more for visits and procedures and slashing critical support staff - rather than to serve the best interests of patients and clinicians. Part of the corporate rush to invest aggressively in primary care is the unintended consequence of privatizing Medicare and moving away from the fee-for-service payment model; private health insurers now receive a lump sum "value based care" payment for every enrolled Medicare beneficiary based on their medical complexity and health risks, a process that Paul Branstad and Claude Maechling observed can easily be gamed:

Value-based contracts with full-risk capitation payments, mostly Medicare Advantage (MA), but also variants of accountable care organization (ACO) models, have grown rapidly to become the majority payment model for Medicare beneficiaries. However, there is no demonstrated proof that these payment arrangements improve the health of beneficiaries more than fee-for-service arrangements. We also fear that, in their current forms, such contracts reward ever-increasing scale and will evolve into a competition that only the very largest consumer companies can win. Once these winners emerge, their vested interests will focus on preserving their oligopoly at an additional cost to US taxpayers of $75 billion a year. Too late will we realize we have lost our last best chance to reinvent a health care system centered around the large-scale provision of high-quality primary care—even though this is what value-based contracts started out trying to do.

Another reason that retail giants such as Amazon and CVS Health have recently invested billions of dollars in primary care companies (One Medical and Oak Street Health) is that they anticipate steering thousands of patients to their pharmacy and disease management products. CVS Health's CEO is confidently projecting that investors will realize "double-digit returns on invested capital over time as clinics mature and synergies are realized."

Although private investment has infiltrated nearly every sector of health care, including oncology clinics, neonatology practices, and the gastroenterology practice where I refer most of my patients for procedures or challenging gastrointestinal problems, the profit motive may do the most damage in primary care, which improves population health when it is treated as a common good rather than as a loss leader for more profitable procedural subspecialties and hospital-based services. As Soleil Shah and colleagues wrote in the New England Journal of Medicine: "Though potentially beneficial for certain well-insured patients, the trend of corporate investment in primary care could threaten equitable access to care, raise health care costs, and reduce physicians’ clinical autonomy."

Sounding the alarm about the "existential threat of greed" in a JAMA Viewpoint and his Institute for Healthcare Improvement 2022 National Forum keynote address, Don Berwick made these stark observations about the wrong direction that the excessive pursuit of financial profit has been taking the U.S. health care system, and now corporate primary care:

Profit may have its place in motivating innovation and higher quality in health care, as in any industry. But kleptocapitalist behaviors that raise prices, salaries, market power, and government payment to extreme levels hurt patients and families, vulnerable institutions, governmental programs, small and large businesses, and workforce morale. Those behaviors, mostly legal but nonetheless wrong, have now accumulated to a level that poses an existential threat to a sustainable, equitable, and compassionate health care system. ... US health care costs nearly twice as much as care in any other developed nation, whereas US health status, equity, and longevity lag far behind. Unchecked greed is not the only driver of that failure, but it is a major one. Few, if any, other developed nations tolerate the levels of avarice, manipulation, and profiteering in health care that the US does.
Salve lucrum [Hail, Profit!] is the wrong answer.

Photo courtesy of Pompeii in Pictures https://www.pompeiiinpictures.com/pompeiiinpictures/R7/7%2001%2047.htm

Tuesday, May 9, 2023

Updated immunization and screening recommendations aim to eradicate hepatitis B

In November 2021, the Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) replaced risk factor-based eligibility in adults with a recommendation for universal hepatitis B vaccination in persons aged 19 to 59 years. The ACIP noted that despite routine administration of hepatitis B vaccine in infancy, as of 2018 only 30% of U.S. adults had received the full vaccine series, and one half of acute hepatitis B cases occurred in persons aged 30 to 49 years. A national survey of family physicians in February 2022 found that more than half of respondents were not aware of the updated guidelines, and only 8% had fully implemented them.

Gaps in screening and treatment also put patients at greater risk of developing chronic hepatitis B and its complications. An analysis of insurance claims data from 2015 to 2020 found that even though all pregnant patients should be screened for hepatitis B at their first prenatal visit to prevent perinatal transmission, 14.6% did not have hepatitis B surface antigen (HBsAg) testing, representing as many as half a million births each year. Another study found that between 2016 and 2019, less than 30% of persons with chronic hepatitis B and cirrhosis started antiviral therapy within 12 months of diagnosis.

Since access to hepatologists is a barrier to patients with hepatitis B receiving appropriate management, a previous AFP Community Blog post described a practice model for family doctors to evaluate and treat these patients “in-house.” However, the complexity of screening and management guidelines has led to calls for a simplified approach to hepatitis B. In response, the CDC recently recommended that adults aged 18 years and older be tested for hepatitis B at least once during their lifetimes, regardless of prior immunizations or risk factors, mirroring the universal screening approach to hepatitis C and HIV. (Notably, the U.S. Preventive Services Task Force currently recommends a risk-based screening strategy in adolescents and adults.) To facilitate interpretation, screening should include HBsAg, antibody to HBsAg, and antibody to hepatitis B core antigen.

In a JAMA Viewpoint, Dr. Samuel So and colleagues asserted that as two-thirds of non-institutionalized persons with chronic hepatitis B are unaware of their infection, universal screening and vaccination of adults “are a major step forward to reducing chronic hepatitis B-related morbidity and mortality in the U.S.” Another commentary emphasized focusing on health equity in the national push to eradicate hepatitis B and hepatitis C, which is the target of a recently proposed national initiative. A white paper that I co-authored for the Hepatitis B Foundation presented challenges to implementing the updated CDC recommendations, best practices in primary care and hospital settings, and priority action items involving education, multi-stakeholder collaborations and technology innovations, and addressing vaccine hesitancy.

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This post first appeared on the AFP Community Blog.

Monday, May 1, 2023

Have pharmaceutical conflicts of interest unduly influenced asthma guidelines?

The single maintenance and reliever therapy (SMART) treatment approach to patients with asthma, outlined in the article on chronic asthma treatment in the April issue of American Family Physician, has consistent supporting evidence from multiple randomized controlled trials. A practical guide to implementing SMART has been widely disseminated to clinicians. However, an editorial by Dr. Steve Brown cautioned that SMART, which is strongly recommended in the 2022 GINA guidelines, has been “heavily influenced by the pharmaceutical industry,” namely AstraZeneca, which markets budesonide/fomoterol (Symbicort), the combination inhaler primarily studied in the trials:

The GINA board of directors and scientific committee members have substantial financial conflicts of interest. Twelve of 17 members, including both chairs, have received personal fees from AstraZeneca. … A 2018 systematic review of SMART for persistent asthma found 16 RCTs, and 15 of those evaluated SMART as a combination therapy with budesonide and formoterol in a dry-powder inhaler. Fourteen of the 15 studies were funded by AstraZeneca, had an AstraZeneca employee as a coauthor, or had authors who received honoraria or fees from Astra-Zeneca.

Why is it problematic that clinical trial investigators and GINA guideline panelists have numerous industry ties? A 2017 Cochrane review concluded that “sponsorship of drug and device studies by the manufacturing company leads to more favorable efficacy results and conclusions than sponsorship by other sources,” an inherent industry bias that “cannot be explained by standard ‘risk of bias’ assessments.” A 2020 systematic review found that guidelines with panelists with financial conflicts of interest were 26% more likely to favorably recommend a therapy than those without such conflicts.

In comparison to GINA, the less-conflicted panelists of the National Asthma Education and Prevention Program (NAEPP) focused guideline update, discussed in a previous AFP editorial, made a narrower “conditional” recommendation for SMART in patients age 12 years or older with moderate to severe persistent asthma.

Although some think that public disclosure of conflicts of interest can prevent or mitigate bias in clinical recommendations, Dr. Jay Siwek, my longtime mentor and editor-in-chief emeritus of AFP, has previously argued regarding clinical review articles and editorials that disclosure of conflicts is not enough. Note: I do not have any conflicts of interest related to the topic of this blog post.

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This post first appeared on the AFP Community Blog.