Courage and consequences at the CDC

In a recent presentation to preventive medicine residents at Johns Hopkins, I reflected on the painful circumstances that led to my resignation from the Agency for Healthcare Research and Quality (AHRQ) in November 2010. In short, political decision-makers well above my pay grade attempted to protect Democratic congressional majorities from blowback from an anticipated recommendation against prostate cancer screening by forcing the U.S. Preventive Services Task Force to cancel a scheduled meeting. Until this year, when Health and Human Services Secretary Robert F. Kennedy, Jr. cancelled the USPSTF's July meeting and expressed his intent to replace the entire panel, it was arguably the worst example in the Task Force's history of politics trumping science. (This time is worse - a LOT worse.)

Last week, the HHS Secretary fired recently confirmed Centers for Disease Control and Prevention (CDC) Director Susan Monarez over her unwillingness to “to rubber stamp [vaccine] recommendations that flew in the face of science.” In protest, three senior CDC officials simultaneously resigned. On his Inside Medicine Substack, Dr. Jeremy Faust posted the full text of the e-mails that Dr. Deb Houry, Dr. Demetre Daskalakis, and Dr. Daniel Jernigan sent to their colleagues announcing their respective resignations. Without question, these three doctors were far more critical to the day-to-day work of the CDC and HHS than I ever was or might have been at AHRQ. But their collective departure, like mine nearly 15 years ago, raises an important question: when a public servant who is also a health care professional witnesses the federal government taking immoral or profoundly troubling actions, is it more courageous to step down (and draw attention to how these actions endanger health) or to remain in place and continue to resist from the inside, hoping that eventually new leadership will restore the primacy of science and evidence-based medicine?

My red line was that the delay - which ended up being 17 months long - in ratifying the USPSTF's "D" recommendation against PSA-based prostate cancer screening would ultimately injure hundreds of thousands of patients who accepted screening without being aware of the Task Force's determination that it was more likely to cause them harm than good. My primary professional identity was and remains that of a family physician, and inherent in this identity is an obligation to provide patients with the best understanding of the science to help them make health decisions. Being told that I had to set this obligation aside because it might damage the electoral prospects of a Presidential administration and his political party was, in my view, unconscionable.

On the other hand, I admire my colleagues at AHRQ who chose to stay and sustain the USPSTF from the inside. A few still work there; others, unfortunately, were given pink slips by Elon Musk's Office of Government Efficiency when his group of twenty-something contractors couldn't figure out what the agency did that was important enough to warrant employing a few hundred scientists. No doubt the Task Force would have been much worse off if every member of its support staff had walked out with me on my last day and switched to careers in academic medicine. Leaving an impossible situation can be courageous, but staying on is, too. I salute Dr. Monarez and her departed senior leaders at CDC for their principled public resistance, but I also support the many staff who have remained despite RFK Jr.'s horrific interference with the agency's mission to protect the public's health.

Do pharmaceutical conflicts of interest compromise the AAP guideline on childhood obesity?

In January 2023, the American Academy of Pediatrics (AAP) published a clinical practice guideline on the evaluation and treatment of obesity in children and adolescents. Dr. Kathryn McKenna and I noted in an editorial in American Family Physician that the recommendation to consider prescribing weight loss drugs in adolescents 12 years and older was based primarily on short-term studies: “only 5 out of 27 randomized controlled trials [available to the AAP] included results beyond six months.” Although the percentage of US adolescents with obesity who were prescribed drugs rose modestly between 2018 and 2023, a recent study found that prescribing increased immediately after the guideline’s publication and every month thereafter through the end of 2024.

To be sure, the effects of nondrug interventions for obesity have been discouraging. A Cochrane review from 2020 found that combined dietary and physical activity interventions in adolescents 13 years and older did not lead to statistically significant changes to body mass index. Nonetheless, the US Preventive Services Task Force found insufficient evidence on the harms of long-term obesity medication use in children and decided to recommend only intensive behavioral interventions.

An analysis in the BMJ highlighted undisclosed financial conflicts of interest involving several authors of the AAP guideline and its accompanying technical report. Three guideline authors and one systematic review author received payments from pharmaceutical companies for consulting, travel, and other compensation between 2017 and 2023 ranging from $2,750 to $46,000; five other guideline authors received smaller amounts for meals and honoraria. From 2012 to 2024, 11 developers of glucagon-like peptide 1 (GLP-1) receptor agonist drugs made an estimated $1.9 to $2.6 million in corporate sponsorship payments to the AAP, including Novo Nordisk (semaglutide) and Eli Lilly (tirzepatide).

The AAP is hardly alone in permitting financial ties to drug companies. Other studies identified industry payments to the authors of the American Diabetes Association and the Infectious Diseases Society of America clinical practice guidelines, and 12 of 17 members of the 2023 board of directors and scientific committee of the Global Initiative for Asthma (GINA) received personal fees from AstraZeneca, which makes a brand-name inhaler used in the single maintenance and reliever therapy (SMART) treatment approach recommended by GINA guidelines.

Some would argue that the AAP guideline authors may have erred in not disclosing their pharmaceutical ties, but they would have likely come to the same conclusions about the effectiveness of GLP-1 receptor agonists and other weight loss drugs for adolescents. A counterpoint is that industry payments to individuals, regardless of amount, influence prescribing behavior and that those in a position to change the standard of care for children with obesity should refuse such payments. Finally, sound reasoning strongly supports that disclosing conflicts of interest is not enough to safeguard against bias in guidelines and other journal publications.

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This post first appeared on the AFP Community Blog.

Research supports moving away from race as a risk factor

In a 2021 American Family Physician editorial on the dangers of incorporating a patient’s race into medical decision-making, Dr. Bonzo Reddick observed, “Although we may hear about biologic or genetic differences between races, there is more variation within races than there is between them.” A recent landmark report from the National Institutes of Health’s All of Us Research Program compared self-identified race and ethnicity categories to continental and subcontinental genetic variation. Analyzing about 2 million common variants in the genomes of more than 230,000 unrelated participants, they found that “participants within self-identified race and ethnicity groups exhibit gradients of genetic variation rather than discrete clusters.”

Among White participants, 8% were found to have some South Asian ancestry, whereas smaller percentages had more than 50% African or Native American ancestry. Similarly, 1 in 100 self-identified Black participants had more than 50% European ancestry. The study also found notable regional differences in ancestry percentages among self-identified Black, Hispanic, and White participants. The researchers concluded that these gradients reflect “the historical impacts of US colonization, the transatlantic slave trade, and recent migrations” and “demonstrate that social constructs of race and ethnicity do not accurately reflect underlying genetic variation.”

Maternal race—specifically, Black race—is associated with increased risk for the development of preeclampsia. In its 2021 recommendation statement on aspirin to prevent preeclampsia and related morbidity and mortality, the US Preventive Services Task Force included Black race as a moderate risk factor, although it noted that it was a proxy for “environmental, social, and historical inequities, … not biological propensities.” However, a multicenter cohort study in JAMA Network Open found that Black race, similar to other moderate risks such as nulliparity, maternal age older than 35 years, and body mass index above 30, was not clearly associated with preeclampsia in the absence of a high risk factor (eg, chronic hypertension).

Finally, a narrative article in the New England Journal of Medicine traced the historical debate over race-based hemoglobin thresholds that began in the 1970s, when epidemiologic analyses showed that on average, Black children’s serum hemoglobin levels were 0.5 g/dL lower than those of White children. Did this disparity reflect inherent biological differences between races or differences in nutrition? Should it support race-based definitions of normal hemoglobin levels? Although some analyses accounting for socioeconomic status and diet no longer found significant racial differences, conflicting guidance from the Institute of Medicine (now the National Academy of Medicine) and the Centers for Disease Control and Prevention persisted into the early 2000s. Today, the World Health Organization, American Academy of Pediatrics, and American College of Obstetricians and Gynecologists all recommend against using race-adjusted cutoffs for diagnosing anemia.

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This post first appeared on the AFP Community Blog.

RFK Jr. is wrong about the US Preventive Services Task Force

Responding to President Trump's criticism of a federal judge who ruled against his asylum policy during his first term, Supreme Court Chief Justice John Roberts released this statement: "We do not have Obama judges or Trump judges, Bush judges or Clinton judges. What we have is an extraordinary group of dedicated judges doing their level best to do equal right to those appearing before them." I am not qualified to comment on how closely federal and Supreme Court justices adhere to the partisan positions of the Presidents who appointed them. However, I was reminded of this statement when, over the weekend, the Wall Street Journal and multiple other news outlets reported that HHS Secretary Robert F. Kennedy, Jr. was planning to fire all the members of the U.S. Preventive Services Task Force (USPSTF) because he considers them "too woke."

I worked for the USPSTF during the Bush and Obama administrations. The transition was seamless; the work went on as before. In the November 2009 uproar caused by the unfortunate timing of the USPSTF's release of a new statement recommending that routine mammography begin at age 50 rather than 40, then-HHS Secretary Kathleen Sebelius clumsily tried to throw the Task Force under the bus by observing (correctly) that all of its members were appointed during the Bush administration - but this completely missed the point that members were selected for scientific expertise, not political ideology. In that respect, the USPSTF has been similar to the ACIP prior to RFK Jr.'s recently replacing all of the latter's members for nakedly political reasons.

"Woke" is such an overused pejorative in conservative political circles that it has lost all meaning, but it seems that the current HHS Secretary is responding to the Task Force's recent efforts to ensure that their recommendations are implemented equitably across people of all races and ethnicities, despite geographic and economic disparities in access to primary care and other resources critical for ensuring health. For example, it's well-documented that eligible Black patients are less likely than others to be offered or undergo lung cancer screening, and that interventions are needed to close this unacceptable gap. This is about as uncontroversial an idea in health care as there is, but apparently it is too much for RFK Jr. More likely, it's merely an excuse to replace the current highly qualified members with his handpicked ideologues. In the words of a former USPSTF member (and my friend and academic collaborator) Russ Harris, MD, MPH:

It may seem excessive [for the USPSTF] to spend so much time and energy on reviewing the evidence for health issues. After all, aren’t people supposed to “do your own research.” I wish it were that easy. What “doing your own research” usually leads to is finding a biased source on the internet or from an “influencer” on social media that is happy to give you their answer. That answer is certainly simple, but often wrong. Such answers are often based on self-interest, or on an ideological agenda, not on a careful review of the relevant evidence.

Recent letters to RFK Jr. from the American Medical Association and 104 health organizations (including 6 of which I am a current or former member) have rightly pointed out that federal policymakers and health insurance plans rely on the USPSTF recommendations to provide coverage of effective preventive services (those rated "A" or "B" with at least moderate certainty of moderate net benefit) such as certain cancer screenings, depression screenings, and preventive services for cardiovascular disease. To tell the truth, I'm less worried about my patients losing access to these services than I am that replacing the current Task Force would result in a flood of signoffs on services where the evidence is insufficient to know if they work (e.g., multicancer screening tests) or tests that sound great intuitively but have been proven to not work, such as screening for asymptomatic carotid artery stenosis, which causes more strokes than it prevents but is nonetheless performed by lots of for-profit companies. The USPSTF is a bulwark in protecting Americans against ineffective or potentially harmful preventive health care, and if RFK Jr. follows through on firing the members of the current panel, that protection will almost certainly cease to exist.

Barrett esophagus and esophageal cancer: sometimes, less treatment is more

Affecting approximately 6% of persons older than 50 years, Barrett esophagus is a premalignant condition that increases the risk of developing esophageal cancer. However, the annual risk of progression to adenocarcinoma in the absence of high-grade dysplasia is low (0.12%-0.24%). Although expert consensus recommends endoscopic surveillance every 3 to 5 years in asymptomatic persons with Barrett esophagus, optimal intervals and the effectiveness of surveillance are not known.

A randomized controlled trial at 109 centers in the United Kingdom compared the outcomes of surveillance endoscopy every 2 years with “at need” endoscopy for symptoms only. In the trial, 3,453 participants with a recent diagnosis of Barrett esophagus with no or low-grade dysplasia were followed for a minimum of 10 years (mean 12.8 years). Symptoms that prompted endoscopy in the “at need” group included dysphagia, unexplained weight loss of more than 7 pounds, iron-deficiency anemia, recurrent vomiting, or worsening upper gastrointestinal symptoms. Within the participants, 93% of the surveillance group and 59% of the “at need” group received at least one endoscopy, with means of 3.5 and 1.4 endoscopies, respectively. Overall, 71 patients (2.1%) were diagnosed with esophageal cancer. There were no statistical differences in time to diagnosis of esophageal cancer, cancer stage at diagnosis, cancer-specific or overall survival.

Standard treatment for locally advanced esophageal cancer involves neoadjuvant chemoradiotherapy followed by esophagectomy. However, rates of serious postoperative complications (30%-50%), and in-hospital mortality (5%) are high. Active surveillance is a strategy to defer or avoid surgical complications in patients with a complete clinical response to chemoradiotherapy. A multicenter, cluster randomized, non-inferiority trial in 12 Dutch hospitals compared survival in 309 persons who received active surveillance vs esophagectomy within 2 weeks of chemoradiotherapy. Patients were eligible if they had no evidence of residual tumors on endoscopic biopsies, ultrasound, or PET-CT after chemoradiotherapy. After a median follow-up of 38 months, the intention-to-treat analysis found that a higher percentage of persons in the active surveillance group (75%) were alive than in the surgery group (70%). Those in the active surveillance group who underwent later surgery experienced similar postoperative complications as those who had standard surgery.

Although this study suggested that active surveillance may be a reasonable option for some with esophageal cancer, there are concerns about the durability of the findings beyond 2 years. A commentary on the study noted that the majority of patients do not have a complete response to chemoradiotherapy and would be ineligible for active surveillance. Surgeons outside of the trial also commented that the assessments for metastatic disease may not have been complete enough, resulting in many persons undergoing esophagectomy without benefit and reducing the apparent effectiveness of surgery.

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This post first appeared on the AFP Community Blog.

Health policy that is neither big nor beautiful

During my second and third years of residency (2002-2004), I periodically volunteered to see patients at a bare-bones clinic at a homeless shelter in Lancaster. We had limited amounts of donated supplies and medications and mostly treated acute problems. One evening, a patient with diabetes came in. He had been taking oral medications but could no longer afford them and was instead giving himself shots of insulin whenever he could afford a few vials. His hemoglobin A1c level was 15, meaning that he was walking around with an average blood sugar level of around 400 and was one mild illness away from a health catastrophe. I asked him to come see me in my faculty supervised clinic at the hospital and referred him to a social worker. Miraculously (in those pre-Affordable Care Act days, Medicaid eligibility was much less generous for single "able bodied" working adults without children), it turned out that he qualified for Medicaid. By the time I graduated, his diabetes, blood pressure, and cholesterol were well-controlled and he had saved enough money to move into his own apartment.

Like every major medical and hospital association in the United States, I lobbied against the budget reconciliation bill that squeaked through the House and Senate and that President Trump signed on July 4th. I send multiple e-mails to my representatives in Congress and encouraged others to do the same. The cuts to Medicaid and the USDA's Supplemental Nutrition Assistance Program (SNAP), totaling $1 trillion over the next several years, don't even come close to filling the $4.3 trillion budget hole created by extending tax cuts that overwhelmingly benefit people like Elon Musk, Jeff Bezos, and Trump himself.

When some health policy researchers got wind of the options being considered to reduce federal Medicaid spending, they published a timely analysis in the Annals of Internal Medicine that projected the impacts of various cuts on Medicaid enrollment and the uninsured. The bill then being considered by the House was estimated to reduce the number of people with Medicaid by more than 10 million and increase the number of uninsured persons by nearly 8 million (because some people would be able to obtain another form of insurance due to increased income or becoming eligible for workplace coverage).

These estimates were horrifying enough, but the Senate version of the bill - the one that President Trump signed on America's 249th birthday - cut even deeper. 11.8 million people are expected to become uninsured, and (outside of the bill, due to Congressional inaction) an additional 5 million will lose private marketplace coverage due to no longer being able to afford to pay the premiums.

Medicaid is just the tip of the iceberg. As a fellow Pennsylvania physician observed, Medicaid cuts will hurt all American children - not just those publicly insured, since pediatric hospitals and health systems rely heavily on Medicaid rather than the relatively more generous Medicare payments that fund adult health care. States will either try to stretch reduced Medicaid funds to cover the same number of people, lower payments to doctors and hospitals, or both. Hospitals will be forced to close, leading to mass layoffs and more people with few insurance options other than Medicaid. Similarly, SNAP cuts will hurt American farmers and grocery stores in underserved areas where people will have less to spend on food. The Commonwealth Fund estimates that by 2029, the bill's impacts will include 1.2 million jobs lost nationally, depressing collective state gross domestic products by $154 billion and state and local tax revenue by $12.2 billion.

By then, a new administration will have been inaugurated that will need to clean up one big, ugly mess that the federal government created.