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.