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.

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.

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.

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.

Family physicians perform high-quality colonoscopies, but access is an issue

Most patients who choose colonoscopy as a screening test for colorectal cancer are referred from primary care to a gastroenterologist or other specialist who performs endoscopy. But that wasn’t the case for the estimated 1 in 15 US patients whose screening colonoscopies were performed by family physicians in 2021. A study of an insurance claims database found that family physicians are more likely to perform colonoscopies in older, male patients residing in more rural areas of the Midwest, South, and Western United States.

The American Academy of Family Physicians (AAFP) maintains that clinical privileges should be based on documented training and experience rather than the physician’s specialty. In 2000, American Family Physician published an AAFP position paper (an updated version currently resides on the AAFP website) emphasizing that “colonoscopy can be a natural extension of the total care provided by a well-trained family physician.” In 2008, a Society of Teachers of Family Medicine consensus statement classified colonoscopy as a core procedure that family medicine residents should not only be exposed to but also “have the opportunity to train to independent performance.”

A 2009 meta-analysis of 12 studies (n = 18,292) of screening colonoscopies performed by primary care physicians and a later study of faculty and residents at a single, university-affiliated family medicine center concluded that their performance on quality, safety, and efficacy indicators (reach-the-cecum rate, major complication rate, and adenoma detection rate) was comparable to those recommended by the major gastrointestinal endoscopy societies. In addition, a recent analysis of colonoscopy quality at two high-volume rural programs (University of Texas Southwestern and University of North Dakota) for family physicians, general surgeons, and gastroenterologists found no statistical differences in performance by provider type.

Data indicate that screening colonoscopies are overused and that a colonoscopy-first strategy may only be marginally better than sequential fecal immunochemical testing in reducing colorectal cancer mortality. Nonetheless, millions of US adults older than 50 years have never been screened for colorectal cancer and could potentially benefit from having access to family physician–performed colonoscopy services. Thus, the decline in endoscopic care (including flexible sigmoidoscopy) by family physicians in both urban and rural areas is cause for concern. From 2016 to 2021, the percentage of screening colonoscopies performed by family physicians decreased from 11.3% to 6.7%, and less than 2% of board-certified family physicians report performing colonoscopy in their practices.

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This post first appeared on the AFP Community Blog.

PSA screening: shared decision making is a flawed approach

In early 2020, I accepted an invitation to participate in a live debate with a nationally prominent academic urologist at the annual scientific meeting of the American Society for Men's Health. The topic: "The Great Debate of the 21st Century: To PSA screen or not to screen." Unfortunately, the COVID-19 pandemic caused the meeting to the canceled. By the time I was re-invited in 2021, my academic interests had drifted away from prostate cancer screening, so I declined. But over the past 5 years, I have watched with increasing dismay as family physicians and urologists (mis)interpreted the U.S. Preventive Services Task Force's more permissive stance on PSA screening as a license to start screening indiscriminately again without warning men about the adverse consequences of doing so. "We Should Be Doing Fewer PSA Tests, But We Are Doing More," I pleaded in a 2022 Medscape commentary for primary care physicians. I moved to Lancaster and was appalled when my program's residents received a lecture from a urologist chastising us for not ordering enough PSA tests because we apparently cared more about a few patients avoiding erectile dysfunction and urinary incontinence than the "millions" of lives that could be extended by screening. So I dove back into the evidence, read pretty much every paper on PSA screening published since the pandemic began, and concluded that our current approach to shared decision making is fatally flawed, and that we would be better off not using the PSA test for screening at all.

Then I wrote a paper about it. Here is my unfiltered conclusion:

Even though [the PSA] test's flaws, including poor accuracy and the cascade of interventions that follow a positive result, are well established, guideline developers have assumed that shared decision-making would limit the population of men being screened to those prepared to endure the lifelong monitoring and interventions that follow a positive PSA result. The preponderance of the evidence has not reflected this assumption. The net population benefit of prostate cancer screening is too small—particularly in men older than 70 years—to justify continuing this failed approach. Rather than treating PSA as an elective test and trying unsuccessfully to present “both sides” of the screening decision, primary care physicians should go back to discouraging its use.

You can read my full editorial on PSA screening in the January issue of American Family Physician.