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.

Primary care for all Americans

"The Gilded Age of Medicine is Here," announced the title of a recent New Yorker article about the tactics of private equity firms that provide infusions of cash to struggling hospitals in order to extract hundreds of millions of dollars in profits by slashing costs to the bone and endangering the health of patients. As Dr. Dhruv Khullar writes, "They [private equity] are hardly the only corporations to learn this lesson. Increasingly, health insurers, private hospitals, and even nonprofits are behaving as though they aim first to extract revenue, and only second to care for people. People often are viewed less as humans in need of care than consumers who generate profit." Dr. Don Berwick's dire warning about the existential threat of greed on the failing American health care system seems to be coming true, to the extent that the brazen assassination of an insurance company executive in midtown Manhattan elicited far more outrage about delayed or denied care than sympathy for his family's loss.

Nevertheless, the U.S. is at the threshold of a once-in-a-lifetime opportunity. In 2023, a decade after the Affordable Care Act expanded Medicaid and began offering subsidized private insurance options in national and state-run marketplaces, the share of the population with health insurance reached 92.5% - the highest ever. Contrary to many predictions, the ACA coverage expansions did not increase health care spending growth. For the first time in history, then, America is on the brink of near-universal insurance coverage, despite the incoming administration's determination to roll back many of the policies that got us to this point.

We should no longer be debating whether or not having health care insurance is better than not having it. What we should be discussing is why health care costs keep climbing so rapidly, which leads directly to higher premiums and the proliferation of high-deductible policies that make accessing care unaffordable even for the insured. In some cases, more regulations are the answer. Both political parties have belatedly recognized, for example, that the inflated costs of prescription drugs are due not only to pharmaceutical company avarice but also pharmacy benefit managers (PBMs) that "steer patients toward pricier drugs, charge steep markups on what would otherwise be inexpensive medicines and extract billions of dollars in hidden fees," not only hurting patients and employers but driving independent local drugstores out of business.

Even if drugmakers and PBMs could be brought to heel, though, America is still lacking a major ingredient of a truly patient-centered health system: well-resourced, adequately supported primary care. These days, most adults need to wait several months for a new patient appointment with a family doctor, if they can get one at all. This isn't only because too few medical students are choosing primary care residency programs; it also reflects generalist physicians leaving practice prematurely due to burnout.

There are hopeful signs that policymakers are finally waking up to the need to provide more support to primary care. The 2021 National Academy of Medicine report "Implementing High-Quality Primary Care: Rebuilding the Foundation of Health Care" advanced the concept of primary care as a common good rather than a commodity. The Primary Care Collaborative's 2024 Evidence Report found that primary care centric Accountable Care Organizations produce more than twice as much net savings as ACOs with smaller proportions of primary care clinicians. The state of Massachusetts is now proposing a prospective payment model to double primary care investment, while the Centers for Medicare and Medicare Services is adding payments for "advanced primary care management" to compensate practices for core tasks that they are already doing or should be doing anyway.

But it's not enough to wait and hope that policymakers will figure this out on their own. A grassroots movement is underway. A few months ago, I found myself in a conference room in Philadelphia listening to speakers introduce Primary Care for All Americans, a volunteer organization whose mission is to bring people from all walks of life together "to create a health care system that is for people, not for profit, that serves all Americans, in every neighborhood and community." PCAA hosts weekly online conversations about making primary care accessible for all and provides resource-packed state and local playbooks for individuals who are looking to support primary care in their states and communities. Join the movement and seize this opportunity to bring an end to the Gilded Age of American medicine.

Overtreatment of prostate cancer in the active surveillance era

Concerns about overdiagnosis of clinically insignificant prostate cancer through prostate specific antigen (PSA) screening motivated the 2018 American Academy of Family Physicians’ (AAFP) recommendation against routine screening for prostate cancer. Explaining the AAFP’s position, Drs. James Stevermer and Kenneth Fink wrote in an AFP editorial:

Few men diagnosed with and treated for prostate cancer will experience a mortality benefit, and an estimated 20% to 50% of those treated will never become symptomatic, even without treatment. This high rate of overdiagnosis from prostate cancer screening exposes many men to harms without any potential benefit.

Active surveillance is a management strategy that is intended to limit overtreatment of localized prostate cancer by monitoring patients with periodic PSA measurements and prostate biopsies to delay or avoid curative therapy (radical prostatectomy or radiation therapy) and its adverse effects. Watchful waiting refers to clinical observation only. A recent analysis of the U.S. Surveillance, Epidemiology, and End-Results (SEER) prostate cancer database found that among men with intermediate-risk prostate cancer (based on pathology and a PSA level lower than 20 ng/mL), active surveillance or watchful waiting increased overall from 5% in 2010 to 12.3% in 2020, with higher percentages of patients with more favorable pathology or lower PSA levels choosing one of these strategies. Of note, men older than 80 years were more than four times as likely to choose observation than men in their 50s (24.9% and 6.1%, respectively).

Another study of patients in the Veterans Affairs health system examined changes in the likelihood of curative therapy in men with prostate cancer and limited longevity. Guidelines recommend against PSA screening or curative treatment for prostate cancer in men with life expectancies of less than 10 years because the benefits take more than a decade to appear, whereas the harms manifest in the short term. Nonetheless, among men with intermediate-risk prostate cancer and life expectancies of less than 10 years, overtreatment rose from 37.6% in 2000 to 59.8% in 2019, with 78% receiving radiation therapy and 22% undergoing surgery.

Radiation therapy may be viewed by patients and physicians as having fewer adverse effects than surgery, but it is hardly benign. A prospective cohort study of nearly 30,000 men who participated in two prostate cancer prevention trials found that compared with untreated participants, men who had radiation therapy were 2.76 times more likely to develop urinary or sexual complications, 2.78 times as likely to develop bladder cancer, and 100 times as likely to develop radiation cystitis and proctitis. It makes no sense to expose patients to these risks who have little opportunity to benefit, two geriatricians wrote in a JAMA Internal Medicine commentary titled “Do Not Wait to Consider Life Expectancy Until After a Prostate Cancer Diagnosis”:

Limited life expectancy increases the likelihood of experiencing harms all along the diagnostic and treatment cascade following screening. Time spent diagnosing, monitoring, and treating asymptomatic prostate cancer in men with limited life expectancy distracts from monitoring and treating their symptomatic life-limiting illnesses. Also, limited life expectancy increases the likelihood of complications from most procedures, including radiation therapy.

A previous AFP article that reviewed treatment options for localized prostate cancer, including active surveillance, included the patient-administered Charlson Comorbidity Index and a life expectancy table for U.S. men. A 2019 AFP editorial provided more guidance for estimating and having conversations about life expectancy with older patients.

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This post first appeared on the AFP Community Blog.

In asymptomatic severe aortic stenosis, is earlier intervention better?

Affecting three in 100 adults older than 65 years, aortic stenosis is classified as mild, moderate, and severe based on echocardiographic measurements. The onset of symptoms—dyspnea, volume overload, angina, syncope—is associated with a poor prognosis and is the usual indication for aortic valve replacement. Although valve replacement traditionally required open surgery, transcatheter aortic valve implantation (TAVI) has become increasingly common. A JAMA review article quotes a 2020 American College of Cardiology/American Heart Association guideline as recommending surgical aortic valve replacement (SAVR) for patients younger than 65 years, TAVI for patients 80 years or older, and either procedure in patients 65 to 79 years, depending on operative risk and comorbidities.

A recent editorial in the Journal of the American Heart Association discussed a “paradigm shift” in management of severe aortic stenosis: 69% of Medicare fee-for-service beneficiaries who underwent aortic valve replacement from 2012-2019 had TAVI, with the percentage undergoing SAVR falling from 75% in 2012 to just 10% in 2019. In addition, the overall volume of procedures tripled during this period, suggesting either a dramatic increase in disease severity or more likely, a lower threshold for intervention.

Whether aortic valve replacement in older adults without symptoms of severe aortic stenosis is more beneficial than waiting for symptoms of left ventricular dysfunction to develop is a topic of ongoing research. Two randomized trials published last month shed some light on this question. In a multicenter trial in the United States and Canada, 901 patients older than 65 years (mean age 75.8 years) with asymptomatic severe aortic stenosis were randomized to early TAVI or guideline-recommended clinical surveillance. The primary endpoint was a composite of death, stroke, or unplanned cardiovascular hospitalization. After a median follow-up of 3.8 years, patients assigned to early TAVI had lower mortality (8.4% vs 9.2%), fewer strokes (4.2% vs 6.7%), and fewer unplanned hospitalizations (20.9% vs 41.7%). Of the clinical surveillance group, 87% eventually underwent aortic valve replacement.

A second trial in the United Kingdom and Australia studied 224 patients (mean age 73 years) with asymptomatic severe aortic stenosis and a cardiac MRI showing myocardial fibrosis, which predicts left ventricular decompensation and a poor long-term outcome. Participants were randomized to early aortic valve replacement or conservative management. Although the primary outcome, a composite of all-cause death and unplanned hospitalization related to aortic stenosis, occurred less frequently in the intervention group (18%) than in the control group (23%), this difference was not statistically significant (hazard ratio = 0.79; 95% CI, 0.44-1.43). An accompanying editorial observed that this trial, which fell short of its target enrollment of 356 patients, was underpowered to detect a difference in the outcome. Further, because of scheduling difficulties, 14% of participants in the intervention group had not received valve replacement at 12 months after enrollment. Finally, based on older guidelines that limited TAVI to patients at high operative risk, 75% of the intervention group had SAVR rather than TAVI.

Although the results of these trials can be interpreted as favoring early TAVI in patients with asymptomatic severe aortic stenosis, more studies are needed to ensure that the “paradigm shift” toward early intervention is based on good evidence rather than surgical preference.

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This post first appeared on the AFP Community Blog.

My favorite public health and health care books of 2024

Five moving memoirs and five more outstanding nonfiction titles comprise this year's 10th annual list of my favorite health books, listed alphabetically by title below. For more great reads, feel free to browse my lists from 2023, 2022, 2021, and 2015-2020. Hope this list helps with your holiday shopping!

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1. Crisis Averted: The Hidden Science of Fighting Outbreaks, by Caitlin Rivers

2. The Emergency: A Year of Healing and Heartbreak in a Chicago ER, by Thomas Fisher

3. The Good Doctor: A Father, a Son, and the Evolution of Medical Ethics, by Barron Lerner

4. The Hospital: Life, Death, and Dollars in a Small American Town, by Brian Alexander

5. How Medicine Works and When It Doesn’t: Learning Who to Trust to Get and Stay Healthy, by F. Perry Wilson

6. On Call: A Doctor’s Journey in Public Service, by Anthony Fauci

7. Though the Darkness: Medicine, Missions, and Meeting God in Nepal, by Rebecca Martin

8. Until Proven Safe: The History and Future of Quarantine, by Geoff Manaugh and Nicola Twilley

9. War Doctor: Surgery on the Front Line, by David Nott

10. Within Reason: A Liberal Public Health for an Illiberal Time, by Sandro Galea

RFK Jr. and vaccine politics

Several years ago, during the first Trump administration, I excoriated the then-nominee for Secretary of Health and Human Services, orthopedic surgeon Tom Price, for his poor understanding of cancer screening. (Secretary Price was confirmed by the Senate, but ended up serving for less than 8 months and resigning abruptly after Politico discovered he had spent $1 million in taxpayer dollars flying on private jets and military aircraft.) President-elect Trump has stated that he plans to nominate Robert F. Kennedy, Jr. for Secretary of HHS this time around. I don't know RFK Jr.'s views on cancer screening. News stories have focused on his beliefs about water fluoridation, unpasteurized ("raw") milk, and vaccine safety.

Few HHS Secretaries have actually been medical doctors; Dr. Price was the first M.D. to hold the position in 24 years. The position has typically been filled by former Congresspeople, governors, and professional administrators. The majority of the department's budget funds the Medicare and Medicaid health insurance programs. Smaller portions are distributed to researchers through competitive grant applications. RFK Jr. may want to take fluoride out of the water, ramp up consumption of raw milk, and make vaccines optional for school entry, but fortunately, HHS doesn't have direct jurisdiction over any of these issues. State and local governments decide what vaccines to require. As illustrated in a recent Health Affairs analysis, routine vaccine recommendations from the Centers for Disease Control and Prevention (CDC)'s Advisory Committee on Immunization Practices (ACIP) take anywhere from 9 months to 15 years to be incorporated into state requirements for school entry, and in a few cases (such as human papillomavirus vaccine), have yet to be incorporated at all.

I've written previously about the marked contrast between HPV vaccine's extraordinary effectiveness and its underutilization in the U.S., and it strikes me as nonsensical that parents who don't bat an eye at their infants being vaccinated against hepatitis B (a sexually transmitted infection that causes cirrhosis and liver cancer) are reluctant to protect these children a decade later against a sexually transmitted infection that causes cancer. As vaccine law expert Richard Hughes pointed out in a recent essay, however, vaccine politics frequently defies public health interests. As a member of the Arkansas State Board of Health, he unsuccessfully lobbied for an HPV vaccine requirement:

I approached Governor [Mike] Huckabee’s health adviser and mentioned my interest in promoting the policy’s adoption through the board. The governor’s endorsement, I urged, would demonstrate his commitment to public health as he prepared to make a bid for the presidency. The response was a predictable but polite “no.” For all his championing of public health, the governor was a conservative former Baptist pastor. Many of his strongest supporters would undoubtedly object to the vaccine mandate on moral grounds. Moreover, it could cost him support in the 2008 presidential primaries, where he eventually came in second place to John McCain.

In another important paper, University of Pennsylvania professor Angela Shen warned of "three significant forces in play that jeopardize the continued success of vaccines": the withdrawal of federal support for COVID-19 and other vaccines for uninsured adults; a rising tide of misinformation and disinformation; and a "growing political and partisan divide" around vaccines. During the pandemic, RFK Jr. was identified by researchers as one of the "Disinformation Dozen" - 12 people who originated or amplified 65% of misleading or erroneous anti-vaccine claims on social media platforms. In 2019, his anti-vaccine platform was powerful enough to convince a large portion of the population of Samoa to refuse measles, mumps, and rubella (MMR) vaccines after two children died after receiving MMR vaccines that were accidentally mixed with expired anesthetic rather than the appropriate diluent. As a result, the following year a measles outbreak caused 5,700 cases (3% of the population) and 83 deaths.

A CDC report published yesterday showed that uptake of influenza, COVID-19, and respiratory syncytial virus (RSV) vaccine among adults has been modest as we enter the respiratory virus season (previously known as "flu season"). 35% and 18% of adults have received this year's flu and COVID-19 vaccines, respectively, and 30-40% of eligible adults (age >75 or age 60-74 at increased risk for severe disease) have ever received an RSV vaccine (including last year). COVID-19 vaccine uptake is actually a bit higher than last year, though with less than half of seniors having received it, there are still a lot of vulnerable adults out there.

Side note: Kristen Panthagani, writing in Your Local Epidemiologst, had a fantastic post in September explaining the multiple mistakes in health communication that (mis)led many Americans to expect a "perfect" COVID vaccine. The bottom line: no vaccine confers 100% immunity or is 100% protective for life. The reason we rarely see measles or polio or diphtheria anymore is that 95% or more Americans have been vaccinated and have some immunity, so a chain of transmission has trouble getting established. But if and when that percentage drops, watch out! (See Samoa, 2019.)

It shouldn't surprise any of you that I strongly oppose having RFK Jr. become the next Secretary of HHS. It isn't because he isn't a health professional or doesn't have any experience running an organization of this size (or even the smaller size it might become once the inefficiently two-headed Department of Government Efficiency goes after it). It isn't even because he's a longtime antivaxxer. It's because RFK Jr. has shown time and time again that no amount of scientific evidence will change his deeply rooted, crackpot conspiracy theories about public health. Regardless of the actual influence he might wield in this position, America doesn't need RFK Jr. "going wild on health" when going wild means more cavities for kids, more foodborne illnesses, and more suffering from vaccine-preventable diseases.