Friday, November 22, 2024

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.

Friday, November 15, 2024

Cholesterol screening in children

The appropriateness of screening for hyperlipidemia in children has been debated for years in the medical literature, including the pages of American Family Physician. In 2010, Dr. Robert Gauer wrote an editorial arguing that screening could identify children at risk of developing premature atherosclerotic cardiovascular disease (ASCVD) and allow clinicians to counsel these patients about lifestyle modification and to start statin therapy.

On the other hand, an opposing editorial by former U.S. Preventive Services Task Force (USPSTF) Chair Michael LeFevre noted that “only 40 to 55 percent of children with elevated cholesterol and low-density lipoprotein (LDL) levels will continue to have elevated lipids on follow-up,” reviewed limitations in the evidence base for screening and treatment, and cautioned physicians against “caus[ing] unintended negative consequences in our zeal to prevent far-off disease.”

In 2012, an AFP Journal Club piece analyzed an article contrasting the USPSTF’s call for more research on childhood lipid screening to an American Academy of Pediatrics (AAP)-endorsed guideline, which suggested checking lipid levels in all children around age 10. Dr. Andrea Darby-Stewart and colleagues favored the USPSTF’s “more rigorous, albeit conservative” position over the AAP’s:

There is no evidence that early identification of hyperlipidemia in children changes long-term outcomes. Let’s focus our limited health care resources where they may do some good: encouraging physical activity and maintaining an appropriate body weight.

The 2019 article, Right Care for Children: Top Five Do’s and Don’ts by Dr. Matthew Schefft and colleagues, revisited the controversial topic and listed routine hyperlipidemia screening in children and adolescents as an overused intervention. In a Letter to the Editor, Drs. Cezary Wojcik and Samuel Gidding disagreed and offered another justification for universal lipid screening: to detect familial hypercholesterolemia, an asymptomatic genetic condition that affects 1 out of every 250 children and leads to premature coronary artery disease.

In the September 2024 issue of AFP, the USPSTF reaffirmed its previous statements that the evidence is insufficient to determine the balance of benefits and harms for screening for lipid disorders in asymptomatic persons 20 years or younger. A Putting Prevention into Practice case study applied the USPSTF’s statement to a common clinical scenario. Finally, an editorial by Dr. Brian Reamy proposed selectively screening for familial hypercholesterolemia with a lipid profile "for all family members older than 9 years who have a first-degree relative with a premature ASCVD event or a relative receiving treatment for LDL cholesterol greater than 190 mg per dL."

Currently, cholesterol screening in children is uncommon. A US electronic medical record study of more than 3.2 million children found that among 9 to 11 year olds, only 9% had a previous lipid profile, rising to 13% in the 17- to 21-year-old group. Although prospective cohort studies have found associations between childhood risk factors and adult cardiovascular events, the value of a lipid profile as a risk factor was called into question by a recent analysis of seven cohorts in the United States, Australia, and Finland (n = 11,500). A multivariable model derived from the data used age, sex, blood pressure, body mass index, and smoking status to predict adult cardiovascular events. Adding lipid measurements to the model did not improve risk prediction.

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This post first appeared on the AFP Community Blog.

Wednesday, November 6, 2024

Legalizing cannabis for medical and recreational use: unintended consequences

Four states voted in yesterday's election on ballot measures to legalize or regulate marijuana (cannabis). As of this morning, it appears that Nebraska will legalize medical cannabis, while Florida, North Dakota, and South Dakota rejected legalizing cannabis for recreational use. A recent study described trends in medical cannabis licensure in 38 states and Washington, DC, from 2020 to 2022. The overall number of enrolled patients increased from 3.1 to 4.1 million, but 13 of the 15 jurisdictions that have legalized recreational use saw decreased enrollment, likely because patients no longer needed a clinician’s authorization to legally purchase cannabis. (In my state of Pennsylvania, where recreational use remains illegal, the prevalence of patients using medical cannabis more than doubled from 236 to 549 per 10,000 people.) Of concern, the percentage of patient-reported qualifying conditions with “substantial or conclusive” evidence supporting benefits of cannabis, as according to the National Academies of Sciences, Engineering, and Medicine, declined from 70% to 54%.

A 2022 Agency for Healthcare Research and Quality review and American Family Physician commentary by Drs. Dean Seehusen and Kaitlin Kehoe concluded that cannabis produced “small to moderate short-term pain relief” in patients with neuropathic pain. Similarly, a review of cannabis and pain management in the current issue of the Journal of the American Board of Family Medicine found low- and moderate-quality evidence that cannabis relieves neuropathic pain or rheumatoid arthritis, fibromyalgia, and other chronic noncancer-related pain. Adverse effects are common, with the most serious and prolonged being cannabinoid hyperemesis syndrome. A previous AFP article presented a suggested approach to distinguishing high-risk use and cannabis use disorder from potentially appropriate medical uses.

In New York, where recreational cannabis became legal in 2021, a New York Times Magazine story examined the problems associated with regulating sales of a substance that, similar to tobacco and alcohol, is highly addictive. Unlicensed shops dispensing cannabis vastly outnumber legal dispensaries because the former’s products can be priced more cheaply and thus cater to customers with cannabis use disorder:

Perhaps marijuana is not as bad as alcohol or cigarettes. But saying it is not as bad misses the point: Marijuana does hurt a substantial portion of its consumers, often quite badly. And there is no reason to think that businesses won’t sell marijuana to those it hurts, if they’re allowed to. What the alcohol and tobacco markets show us, rather, is that addiction and profit don’t mix well. … The goal is to find a balance between the harms of prohibition and those of commercialization.

Although many adults in the United State believe that cannabis use and secondhand smoke exposure is safer than that from tobacco, there is ample evidence of negative effects on short- and long-term outcomes. An FPIN Clinical Inquiry found that legalization of recreational cannabis is associated with an increase in cannabis-related emergency department visits. A recent systematic review and meta-analysis of 63 observational studies (n = 438,329) concluded that cannabis use in those younger than 24 years is associated with lower school grades; lower likelihood of high school graduation, university enrollment, and postsecondary degree attainment; and increased school dropout rates and absenteeism.

Finally, a cross-sectional analysis of data from the 2021-2022 National Survey on Drug Use and Health found that 16% of full-time employed adults used cannabis in the previous month, with 6.5% meeting criteria for cannabis use disorder. A dose-response relationship occurred between increasing frequency of cannabis use and cannabis use disorder severity and increased incidence of missed work for illness, injury, or nonmedical reasons.

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This post first appeared on the AFP Community Blog.

Thursday, October 31, 2024

What else could we buy with the billions we spend on cancer screening?

We are five days away from a very consequential U.S. election, and living in Pennsylvania, I'm reminded of that every time I pass a billboard on the highway, turn on the television, or look at my cell phone. (Dear campaigns: I've decided whom I will be voting for. Please stop texting me. Please.) Few reporters or bloggers have been paying much attention to the most serious threat to the Affordable Care Act's no-cost preventive services mandate since it became law in 2010. You can take a deep dive into this drawn-out and somewhat convoluted legal odyssey by reading two recent editorials in JAMA, the first one co-authored by JAMA editor-in-chief and former U.S. Preventive Services Task Force Chair Kirsten Bibbins-Domingo, PhD, MD, and the second one by a pair of Harvard Law School professors. In a related Health Affairs Forefront commentary, Richard Hughes explored the "uncertain future" of uniform preventive care recommendations, from legal obstacles to the real possibility that a second-term Trump administration appoints the outspoken anti-vaxxer Robert F. Kennedy, Jr. as Secretary of Health and Human Services.

The spectrum of primary preventive care endorsed by the USPSTF is broad, and includes services such as fluoride varnish application to prevent cavities in children age 1 to 5 years. Wait, don't dentists do that? Yes, but many families with health insurance don't have dental coverage and can't afford the out-of-pocket cost of this periodic service. A recent study showed that the mandate's implementation in January 2015 was associated with a higher likelihood of a privately insured young child in Massachusetts receiving fluoride varnish during a medical visit.

For the sake of argument, let's assume that the courts invalidate the requirement for insurers to cover preventive services without cost-sharing. Fewer people will receive timely screening for cancer. Although it's unclear how many lives will be lost prematurely (the most conservative estimate, none, strikes me as being overly pessimistic), cancer screening costs at least $43 billion annually, and some of that money would presumably become available to spend on other things that improve health.

How about tuition-free medical school for all? My alma mater, NYU, started the trend of multimillion-dollar philanthropy for this purpose, and though $43 billion probably isn't enough of an endowment for all 200 M.D. and D.O. degree granting schools to be tuition-free in perpetuity, it's a pretty sizeable down payment. The problem is, as I predicted in 2019 and reiterated in a recent article in The Atlantic, tuition-free schools (which now include NYU's Long Island School of Medicine, Albert Einstein College of Medicine in the Bronx, Cleveland Clinic Lerner College of Medicine, and Johns Hopkins University) aren't producing more primary care-oriented graduates and "could perversely be making it harder for low-income and underrepresented minority students to go to medical school":

In the year after NYU went tuition-free, the number of applicants shot up by 47 percent. Because the number of slots did not increase proportionally, this made getting admitted dramatically more difficult. High-income applicants have extensive advantages at all levels of higher-education admissions, so making a school more selective virtually guarantees that its student body will become more wealthy, not less, which is exactly what happened at NYU.

So here's another idea: instead of gifting hundreds of thousands of dollars to young adults who are going to become high-earning doctors, what about giving money to people who actually need it? Former Democratic Presidential candidate Andrew Yang highlighted the potential benefits of universal basic income, which he called the "freedom dividend," in his 2020 campaign. He proposed that every American over the age of 18 be given $1000 per month, regardless of income or any other factor. The federal government tested a scaled-back version of this strategy during the COVID-19 pandemic by issuing three rounds of economic impact payments, better known as "stimulus checks." According to the Center on Budget and Policy Priorities, these cash payments, along with other programs such as continuous Medicaid coverage and free school meals, kept 17 million people out above the poverty line.

Pretty much everyone short of the uber-wealthy could probably find something to spend a few thousand dollars on that would make their lives better (including buying something for someone else). But do cash benefits make health better? In 2020, Chelsea, Massachusetts held a lottery in which 1746 of 2880 low-income residents were randomly issued debit cards each month for 9 months, with values ranging from $200-$400 depending on family size. An analysis of what was effectively a randomized, controlled trial showed that persons who received debit cards had significantly fewer emergency department visits overall (217 vs. 317 visits per 1000 persons), including fewer ED visits leading to hospital admission and fewer related to behavioral health and substance use. Interestingly, the intervention group was not more likely than the control group to visit primary care or outpatient behavioral health, so the benefit's mechanism of action is unclear.

Recall that this experiment occurred in the context of the pandemic, with the control group presumably having access to the broader scope of federal benefits mentioned above. I earnestly hope that the defenders of the USPSTF prevail in court and preserve universal access to evidence-based preventive services, including cancer screenings. But if I had to spend the $43 billion on something else that improves health, a monthly cash benefit would be my choice.

Sunday, October 20, 2024

Supreme Court v. Constitution: activism or restraint?

Drafted in 1787, the Constitution has been the foundation of the United States's democratic system for over two hundred years. Many historians marvel at how this "living document" has adapted to enormous social and technological change with so few modifications in its text. Part of its longevity can be attributed to the Supreme Court, an institution which interprets the Constitution's words in order to give them practical meaning. During recent years, however, controversial decisions have prompted "strict constructionists" to attack the court for not exercising judicial restraint and applying the words of the Constitution with little regard to the intentions of the Founding Fathers. In contrast, "loose constructionists" argue that because the strengths of the Constitution lie in its implied principles, today's judicial activism is not only justified, but necessary. A closer examination of these views reveals that neither is entirely correct. A more satisfactory solution, tempering idealism with reality, would be a combination of the two.

While many people assume that the Supreme Court can only interpret laws, others assert that it should play an active role in creating policy. Sam Ervin points out that the Founding Fathers denied the Court policymaking power when they vested this power in the executive and legislative branches of government. Furthermore, only Congress and the states can amend the Constitution. Ervin argues that because the Constitution is the "supreme law of the land," the Supreme Court, an adjudicator, must always abide by the intended purpose of laws. Yet he ignores the fact that Congressional compromises often result in pieces of legislation containing vague language. Consequently, the Court usually has considerable leeway in determining how to interpret laws. Ramsey Clark maintains that the Court, through its interpretations, has the responsibility to respond to change when legislators do not: "The Constitution ... must have the durability and wisdom to grow, to encompass essentially new situations, to meet new needs." He applauds the landmark Court decision in Brown v. Board of Education as an example of justices following the spirit of the Constitution even though it did not specifically prohibit the "separate but equal" doctrine. Although Ervin feels that such decisions erode the Court's legitimacy, Clark realizes that "to blame the Court of upholding the [principles of the] Constitution is hardly to respect that document or to seek fulfillment of its word."

Ervin warns that the Court's discretionary power creates the danger of justices flagrantly abusing constitutional interpretations to suit their own interests and beliefs. "Under the guise of interpreting them," he observes, "the Warren Court repeatedly assigned to constitutional provisions meanings incompatible with their language and history." In contrast, Clark finds that the rulings of the Warren Court were needed to "liberate government from the 19th century" and correct injustices in American society. Ervin paints a dangerously idealistic portrait of the Court as a place of complete law and equity; clearly, no justice's decisions are ever entirely fair and impartial. On the other hand, Clark's vague statements about adhering to constitutional "principle" and "spirit" seem to encourage justices to interpret the Constitution's words any way they please.

Obviously, personal beliefs and society's pressures do frequently influence the Court's rulings. For example, the Court will almost certainly overturn its pro-abortion rights Roe v. Wade decision in the next few years because a conservative majority now presides in the place of the liberal majority present in 1973. [Present-day note: my prediction was off by 30 years.] During the Great Depression, a Court which originally declared much of Roosevelt's New Deal to be unconstitutional later gave in to economic realities and approved the federal aid programs. Ervin observes that "these things mean ... nothing to those who would as soon have our country ruled by the arbitrary, uncertain, and inconstant wills of judges than by the certain and constant precepts of the Constitution." Clark responds by citing the 1791 decision to charter a Bank of the United States. In this case, the Constitution's "necessary and proper" clause gave no help to the decision-makers, who instead relief on the "best judgment ... as to what was an appropriate rule for a constitutional federal government." Clearly, even the most impartial justices must sometimes exercise personal judgement when there are no legal precedents to follow.

Even though the philosophies represented by Ervin and Clark do not share ideas in common, the issues on which they focus are remarkably similar. Ervin equates restraint with conservatism and the literal meaning of the Constitution; Clark sees activism as a process that furthers liberalism through figurative interpretations. Ervin is wise to caution against twisting the Constitution's words; even judicial activists with good intentions might, through overzealous interpretations, accidentally destroy the meaning of the most treasured piece of parchment in the United States. Of course, some flexibility is necessary, as Clark explains: "It is hardly surprising that the words of the Constitution, even supplemented by their historical context, do not resolve all the great questions of our time." To a degree, activism and restrain complement each other. The Supreme Court would do best to tread a middle ground, respecting the strengths and weaknesses of both philosophies.

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I wrote this essay on January 2, 1992, when the Supreme Court's incumbent justices were Byron White, Harry Blackmun, William Rehnquist (then Chief Justice), John Paul Stevens, Sandra Day O'Connor, Antonin Scalia, Anthony Kennedy, David Souter, and Clarence Thomas - the only justice who remains on the Court today.

Wednesday, October 16, 2024

Is Congress corrupt?

Hardly a day passes when people do not accuse national lawmakers of being corrupt and engaging in unethical behavior. Many citizens believe that a good deal of waste in government results from the misconduct of Congresspeople who regularly abuse their powers. Since no clearly defined code of Congressional ethics exists, however, there is little agreement over the issue of whether members of Congress are truly corrupt. For example, Mark Green, representing the interest group Public Citizen, argues that most senators and representatives do not try hard enough to avoid conflicts of interest between their governmental responsibilities and private affairs. Edmund Beard and Stephen Horn, on the other hand, assert that many instances of so-called corruption in Congress are often not what they seem to be. In order to determine which view contains the most truth, it is necessary to analyze how varying degrees of interest conflicts, ethics laws, and popular misperceptions influence Congressional behavior.

All members of Congress have financial conflicts of interest; the problem lies in determining which of these conflicts truly violate the public trust. Beard and Horn point out that "outside the boundaries of bribery and overt self-dealing, there is very little consensus ... about what constitutes a legitimate or an illegitimate business or political transaction." Asserting that it would be ridiculous to deny legislators the right to financial security, they quote a Congressman who says, "'I have to maintain outside interests. What if I'm defeated tomorrow? What do I do?'" On the other hand, Green believes that many Congressmen who hold stock in large businesses profit illegally from their power over government contracts. Arriving at the questionable conclusion that holding "sensitive shares of stock" is a sure sign of corruption, Green provides little evidence to show that Congresspeople manipulate tax laws for personal benefit. Although Beard and Horn concede that some members of Congress do occasionally favor bills benefiting their own interests, they also caution against analyzing voting trends from incomplete data.

With regard to another breach of ethics, legislators' use of campaign funds for personal purposes, clear definitions are also a major difficulty. Green argues that a repeated pattern of abuse exists among vacationing Congresspeople who turn pleasure trips into "campaign expenses" by meeting briefly with handfuls of supporters. He cites several specific cases before 1979 as evidence but minimizes the impact of a law the same year restricting the misuse of campaign funds. Even though one must concede that law enforcement in this area of abuse can certainly be improved, another obstacle stands in the way of large-scale investigations. According to Beard and Horn, though all members of Congress view the misuse of campaign funds as serious violations of existing law, they do not always agree where the line should be drawn between personal and political activities because "campaign funds and personal finances may complement each other."

Members of Congress may also be corrupted by private corporations offering favors. Besides enhancing a legislator's prestige, Congressional office entails many fringe benefits, such as the opportunity for unlimited travel and free lodging, courtesy of businesses trying to win influence. However, Beard and Horn's interviews with members of the House reveal that few actually feel obligated to return such favors. In fact, one legislator who once received a free flight to India feels that the "junketing" label is unfair. Yet Green argues that members of Congress can be corrupted by private businesses if they are guaranteed a future reward, such as an important corporate post, upon their departure from politics. However, most Congressional incumbents, who have upwards of an 80% success rate for reelection, have little reason to worry about losing their jobs. Most Congresspeople feel that as long as they are not corrupted by the privileges that come with their positions, they are not violating any existing code of ethics.

While Mark Green seems eager to pounce on the evils of lawmakers, Edmund Beard and Stephen Horn, who recognize that real Congressional practices cannot hope to fulfill idealistic public expectations, present a more convincing view of the controversy surrounding ethics. Although Green charges that Congress should bear the blame for the lack of specific ethics standards, Beard and Horn point out that "any congressional behavior ... not designed to advance the common interests of constituents and country might be termed conflict of interest" and thus be unethical. The more flagrant cases of corruption cited by Green are testimony to the views of some Congressmen, but it does not follow that these cases are routine. Although he believes that "with few barriers against it, potential conflict of interest becomes commonplace," the key word is potential. The watchful eyes of the media, coupled with Congress's own ethics committees, deter corruption by preventing most cases of outright bribery from taking place. Acknowledging the imperfections of a few individual members does not automatically make Congress unethical or corrupt. Ironically, Green makes the most eloquent statement reinforcing this view: "Most members of Congress," he admits, "aren't crooks."

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This is the second of three recently unearthed essays on elections and political institutions that I wrote in 1991, when Donald Trump was a recently divorced real estate developer and owner of a money-losing airline ("Trump Shuttle") and Kamala Harris was a deputy district attorney in Oakland, California.

Saturday, October 12, 2024

Is there a right to not vote?

The right to vote in the direct election of public officials is today taken for granted by citizens of the United States. In the 1960s, a series of civil rights movements finally banned election discrimination and guaranteed the right to vote to every citizen, regardless of race, sex, or religious affiliation. However, because only a minority of Americans actually do vote in local elections, another controversial issue has arisen regarding elections and nonvoting: is there a right not to vote? Nonvoting, which has become much more frequent in recent years, has been viewed as a dangerous sign of voter apathy and a threat to democracy. On the other hand, it has also been dismissed as a minor problem that has been blown far out of proportion. But which view is correct? The answer can only be determined through an analysis of the types of non-voters and the motivations behind their decisions to not vote.

The reason citizens most often give for their decision to not vote is that they don't care about who gets elected because the result will not directly affect them. Curtis Gans notes that although in recent years "the United States has made it easier to vote," fewer ordinary Americans actually do vote, "sapping the voluntary spirit of participation" that is essential in any democracy. In contrast, J. Austin Ranney takes the position that "there is no reason to believe that a high level of nonvoting is, by itself, a symptom of sickness in American society." Quite possibly, if those voters who truly "don't care" were forced to vote to avoid nonvoting fines, their random votes could distort the opinions of voters who did care about the issues. Gans's picture of an "interested few" influencing issues is legitimate, but these people should not be regarded as a political elite. His argument can just as easily state, "if the few who do not care do not vote, then each issue will be settled in favor of the many who do care, satisfying the voters and doing no harm to the nonvoters." Although some European nations require all citizens to vote whether they want to or not, American democracy relies on a sacred doctrine called "majority rules," referring not to a majority of the people, but to a majority of those people who care strongly enough to vote.

The bureaucratic process itself presents another difficulty in getting citizens to vote. In many countries, citizens are registered automatically, but in the United States, a citizen must take it upon himself to register and re-register, especially if he changes his place of residence. Sometimes obstacles in the registration process may frustrate the voter to the extent that he decides that his vote "will not make a difference." Although Ranney agrees that "clearly it is a bad thing if citizens who want to vote are prevented from doing so by law or intimidation," he also cautions that "the most we can realistically hope for ... is a modest increase ... in our average turnouts." Same-day registration might also make elections more susceptible to voter fraud. Although Gans advocates drastic measures such as "reducing the length of ballots" and "establishing a commission to look into ... discrimination and intimidation which still plague our polls," he gravely undermines his own arguments. One of the actions he recommends, an initiative to "reduce the number of elected offices," will in fact reduce democracy and give voters even less of a reason to go to the polls. In contrast, Ranney asserts that even though the registration process can and should be streamlined, "the right to abstain is just as precious as the right to vote."

One real problem pointed out by Curtis Gans is that many Americans do not have enough knowledge to make an educated choice for or against a political candidate or issue; therefore, they have no reason to vote. He laments the breakdown of consensus since the 1960s and points to political factionalism as the cause of many present-day problems such as pollution and big-city crime. Even though a diversity of interests is a strength of American politics, not all the interests of the electorate are represented fairly; Gans describes one group of nonvoters as being "poorer, younger, less educated ... and more urban underclass than the rest of the population." Ranney agrees that this is somewhat true, but he predicts "a major increase in our voting turnouts" once members of minority groups realize that voting can give them a voice in government. This time, both sides are pushing their arguments too far. Ranney's rosy prediction of a "70 to 80 percent voter turnout" once minorities mobilize in politics is clearly high. In addition, Gans's demand for more comprehensive voter information is unreasonable; such information will most likely come from the candidates themselves, who will naturally present themselves in a favorable light. Obviously, voters do not weigh every single detail of an issue when they go to the ballot box, but this fact will not stop most of them from making an educated choice based on their own political beliefs.

Finally, there is the question of voting in a democracy; has a decline in civic responsibility led to a decline in voter turnout? The Declaration of Independence, which set forth the principles of American democracy, states that government derives its powers "from the consent of the governed." Gans points out that low voter turnout has greatly eroded the strength of political parties, but the Founding Fathers did not envision political parties as forums for issues in the first place. Ranney, who believes that voluntary nonvoting does no harm to democracy, feels that voting is not the only way to express "consent." Indeed, many studies show that Americans are more likely to become involved in special interest groups than citizens of other countries with a larger percentage of voters. Therefore, civic responsibility is not on the decline; people have found that a better way to influence government is to find strength in numbers. Voting is an individual act, but political participation, which goes beyond voting statistics, cannot be accurately measured.

Citing low voter turnouts, Curtis Gans mistakingly assumes that "we are ... in danger of becoming a nation governed of, for, and by the interested few." However, Austin Ranney reasons that "we need not fear that our low voting turnouts ... deprive us of the right to call ourselves a democracy." Voter apathy, registration difficulties, and a lack of unbiased information on important issues has always hindered voters and will continue to do so in the future. Although efforts to encourage more people to vote will continue, measures should not be undertaken to require every citizen, whether he or she cares or not, to fill out a ballot just to keep the United States a democracy. Fortunately, American democracy protects a citizen's right not to vote; otherwise, elections might very well be decided on the whims of those people, who in Gans's words, "just don't give a damn."

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This is the first of three recently unearthed essays on elections and political institutions that I wrote in 1991, when Donald Trump was a recently divorced real estate developer and owner of a money-losing airline ("Trump Shuttle") and Kamala Harris was a deputy district attorney in Oakland, California. If you wonder what politics has to do with health care, you haven't been reading my blog for very long.

Monday, September 23, 2024

Improving primary care for patients with opioid use disorder

Earlier this year, the National Center for Health Statistics announced that in 2023, the estimated number of drug overdose deaths decreased for the first time since 2018 from 111,029 in 2022 to 107,543 in 2023. Mirroring the overall trend, overdose deaths involving opioids decreased from an estimated 84,181 in 2022 to 81,083 in 2023. However, medical care of patients who survive overdoses remains suboptimal. A cohort study of more than 130,000 Medicare beneficiaries who experienced a nonfatal drug overdose in 2020 found that although 88.8% received behavioral health services, only 4.2% were prescribed medications for opioid use disorder (OUD) and 6.2% filled a naloxone prescription during the following year.

An analysis of 2022 data from the National Survey on Drug Use and Health suggests that 3.7% of U.S. adults meet DSM-5 diagnostic criteria for OUD. Of this group, 55.2% received some form of OUD treatment, and 25.1% received medications for OUD. Another survey study highlighted one significant barrier to care: Most people either do not know that primary care physicians can prescribe medications for OUD or incorrectly believe that they cannot. Although family physicians make up the largest share of buprenorphine prescribers, according to a 2020 Graham Center Policy One-Pager, the vast majority of family physicians are not prescribing. A systematic review found that physicians are reluctant to address substance use and addiction in their practices because of lack of institutional support, knowledge and skills, and cognitive capacity.

Collectively, these health care system limitations create major gaps in the cascade of care for OUD, according to a JAMA commentary:

The care cascade—widespread screening regardless of the point of care; ensuring diagnosed patients receive treatment, including medications; and retaining patients in care—has been part of medical care for many years and most clinicians, regardless of medical specialty or practice setting, have understood its importance. … With 1 in 27 adults needing OUD treatment, most US clinicians are likely to have patients who need treatment in their practices, whether they are aware of it or not.

For patients with OUD who decline treatment with sublingual or long-acting injectable buprenorphine, clinicians can offer harm reduction strategies such as naloxone distribution, needle and syringe programs, and long-acting reversible contraception, if applicable. A previous AFP article on primary care for persons who inject drugs recommends screening for HIV infection, latent tuberculosis, and hepatitis B and C; providing vaccinations for hepatitis A and B, tetanus, and pneumonia if indicated; and offering HIV pre-exposure prophylaxis.

A cluster randomized trial conducted from July 2021 to June 2022 evaluated the effect of a community-level intervention to increase uptake of evidence-based practices to reduce opioid-related overdose deaths: overdose education and naloxone distribution, medications for OUD, and prescription opioid safety. In the United States, 67 communities in Kentucky, Massachusetts, New York, and Ohio were randomized to the intervention or a wait-list control. Unfortunately, opioid overdose death rates were similar in the intervention and control groups. The intervention’s apparent lack of effect may have been due to the short follow-up period, a coincidental spike in fentanyl-related overdoses, challenges in implementing practice changes during the COVID-19 pandemic, and a low (less than 20%) rate of medications for OUD–prescribing in intervention communities.

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This post first appeared on the AFP Community Blog.

Sunday, September 15, 2024

Get out the vote: supporting civic health in primary care

The national organization Vot-ER designated August as Civic Health Month, “a time to showcase the link between voting and health and celebrate efforts that ensure each and every voter has the opportunity to support their community’s health at the ballot box.” Partners, including the American Association of Medical Colleges, encourage clinicians and health care organizations to support an inclusive democracy by providing patients with nonpartisan education and voter registration services.




A narrative review in The Milbank Quarterly explored the role of primary care in advancing civic engagement and health equity. Research shows that poorer population health is associated with lower voter turnout, with stronger associations occurring in early adulthood rather than in middle age. On the other hand, voting is associated with positive mental health and health behaviors, and higher levels of individual happiness strongly predict future civic engagement. Similarly, volunteers are less likely to be hospitalized and more likely to receive preventive care, even after controlling for age, gender, race, income, education, and insurance status: “In one study of US adults, volunteers spent 38% fewer nights in a hospital and were more likely to receive services such as flu shots, cholesterol screening, mammograms, and prostate exams as compared with nonvolunteers.”

Primary care physicians have successfully engaged patients with “civic health check-ups” at federally qualified health centers and other outpatient locations. In a voter registration project in the waiting areas of two family medicine residency clinics in the Bronx, volunteers registered 114 of 128 eligible patients during a 12-week period, 65% of whom were younger than 40 years. During the COVID-19 pandemic, a general internal medicine clinic in North Carolina used its patient portal to disseminate a REDCap survey containing embedded links to voter resources, including safer alternatives to in-person voting during the 2020 elections.

Outside of these and other individual case studies, voter enfranchisement remains, to borrow from the title of a 2020 perspective article in the Journal of General Internal Medicine, “an underused treatment strategy." To make voting a “standard of care,” Vot-ER is hosting several online events this month for clinicians who are interested in empowering patients to support their community’s health at the ballot box.

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This post first appeared on the AFP Community Blog.

Wednesday, September 11, 2024

Assessing new screening strategies: collaboration and persistence pay off

One strategy that I've found ensures a long and productive academic career is collaborating with talented and curious colleagues. I first put it into practice as a medical officer at the Agency for Healthcare Research and Quality, writing evidence summaries and systematic reviews with other staffers and rotating Preventive Medicine residents. At Georgetown, I collaborated with a terrific team of health researchers to write papers on interpreting and managing test results for Zika virus and COVID-19. I've collaborated with members of the AAFP's Commission on Health of the Public and Science on clinical practice guidelines on COPD exacerbations and blood pressure targets in adults with hypertension. I've collaborated on articles on social media for doctors and advocacy curricula in family medicine residency programs. Through the Lown Institute, I have collaborated on original work estimating the U.S. rate of overuse of screening colonoscopy and the associated harms. And most recently, I worked with a longtime mentor and sometime mentee on an analysis piece in BMJ Evidence Based Medicine that assesses evidence thresholds for proposals for updating established screening strategies.

How this paper came about deserves some explanation. In spring 2021, a company interested in developing a new screening test approached me to ask whom they should consult about the type of evidence required for that test to be endorsed by guideline panels and be covered by insurance. I recommended Russ Harris, a former U.S. Preventive Services Task Force (USPSTF) member who had retired from his academic position at UNC-Chapel Hill but was still interested in pursuing new scholarly projects. Russ then reached out to me in an e-mail: "I don’t think the methods are well worked out for replacing an established screening strategy with a new one in the absence of a formal RCT. Do you have any interest in [doing] some scholarly work on making a contribution to this problem?"

I responded: "I agree with you that it's not clear what kind of evidence is needed to recommend a new screening strategy without a RCT with mortality outcomes. I've been puzzling over this problem since the USPSTF first recommended CT colonography and FIT-DNA for colorectal cancer screening, apparently on the basis of being able to plug their diagnostic accuracy studies into a decision model. I don't see how the TF got to 'high certainty of substantial net benefit' for these tests."

Not long after that, we recruited the third member of our team: Alison Huffstetler, whom I met when she was completing her policy fellowship at Georgetown (we both saw patients in the same family medicine office on Fridays) and had subsequently taken a research faculty position at Virginia Commonwealth University. We decided that we would each study a different condition where the USPSTF had adopted a new screening strategy (cervical, colorectal, and breast cancer) and formulate some common principles that would drive the paper's analysis. Ambitiously, in early May I proposed a timeline that would allow us to "get the bulk of the paper written in the second half of June / first half of July [2021]."

It took a bit longer than that. I moved back to DC from Utah, then moved to Lancaster the following summer to start a new job. Alison got married, changed jobs, and had a baby. Russ kept us on task and, though many Zoom calls, we kept making progress.

Finally, in January 2023 (a year and a half later), we completed a manuscript that we submitted to the American Journal of Preventive Medicine. It was peer reviewed but rejected. We did some rewriting and resubmitted it to JAMA Internal Medicine in June 2023. It was "desk rejected" (not sent out for review) by JAMA-IM, then, in rapid succession, transferred to and rejected by JAMA Health Forum and JAMA Network Open. We moved on to the Journal of Clinical Epidemiology, Annals of Internal Medicine, and then the Journal of General Internal Medicine: same outcome. In the meantime, I presented our paper at the Preventing Overdiagnosis conference in Copenhagen and received some encouraging feedback, which provided enough motivation to keep trying. We embarked on another rewrite and resubmitted the paper as an analysis piece to BMJ in January 2024. The journal's editors rejected it after peer review, but they advised that it could be a good fit for BMJ Evidence Based Medicine. We revised our paper in response to the reviews and submitted it to BMJ-EBM in April 2024. More revision requests ensued. Finally, on August 21, our paper was accepted, and it was published online on September 3.

If you've been keeping count, 8 journals had a chance to publish our manuscript but passed after varying degrees of editorial and peer review. Number 9 turned out to be the charm. This paper required not only collaboration, but dogged persistence and an unswerving belief that we had something of value to contribute to the dialogue around screening. I hope you will agree.

Saturday, August 24, 2024

Strategies for earlier detection of type 1 diabetes in children

An estimated 1.8 million people in the United States, or nearly 1 in 250 children and 1 in 200 adults, have type 1 diabetes. One-third of children with type 1 diabetes are diagnosed when they develop diabetic ketoacidosis (DKA), which is not only life-threatening in the short term but is associated with poor long-term glycemic control. First-degree relatives are 15 times as likely as the general population to have type 1 diabetes, and the American Diabetes Association recommends testing them for pancreatic islet autoantibodies to predict whether they will develop the disease. In a prospective study, children previously identified as being at high risk of type 1 diabetes based on autoantibodies had a low incidence of DKA (3.3%) at the time of diagnosis.

Not only does the presence of islet autoantibodies have prognostic significance, selected patients may be eligible for teplizumab (Tzield), a monoclonal antibody approved by the U.S. Food and Drug Administration in 2022 to delay the onset of type 2 diabetes in high-risk individuals. An international randomized, placebo-controlled trial tested a 14-day intravenous infusion of teplizumab in 76 nondiabetic relatives of patients with type 1 diabetes (including 55 children 8 to 17 years of age) with two or more autoantibodies and impaired glucose tolerance. The intervention group had a median time to diagnosis of type 1 diabetes of 48.4 months, compared with 24.4 months in the placebo group. A subsequent trial showed that teplizumab preserves β-cell function in patients with newly diagnosed type 1 diabetes but does not improve clinical outcomes.

Teplizumab’s exceptionally high price ($13,850 per vial; $194,000 for a 14-day course) and limited benefits—delaying type 1 diabetes onset for an average of 2 years—means that other strategies are needed to improve outcomes in at-risk children. Notably, 80% of patients with type 1 diabetes have no affected relatives. However, it is not known whether screening the general population for type 1 diabetes with genetic or autoantibody tests would lead to more benefits than harms.

One alternative to population-wide screening is using machine learning to predict type 1 diabetes in primary care. A June 2024 study in The Lancet used electronic health records from more than 2 million children in Wales to develop and validate a predictive algorithm for type 1 diabetes based on 26 symptoms, history elements, and timing of primary care visits. When the algorithm was set to generate an electronic alert at 10% of visits, 7 in 10 children with type 1 diabetes would have triggered an alert in the 90 days before diagnosis and been diagnosed an average of 9 days earlier. Fewer alerts (e.g., 5% of visits) reduced the number of early diagnoses. Although the researchers asserted that implementing the algorithm would “substantially reduce the proportion of patients with new-onset type 1 diabetes presenting in [DKA],” they acknowledged that further studies are needed to test the feasibility of this strategy and its relationship to “alert fatigue” and clinician burnout in practice.

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This post first appeared on the AFP Community Blog.

Tuesday, August 13, 2024

Vaccines protect patients from complications of measles, RSV, and COVID-19

August is National Immunization Awareness Month, when public and private health organizations are encouraged to highlight the benefits of vaccines for patients of all ages. In a recent webinar, Centers for Disease Control and Prevention (CDC) Director Mandy Cohen, MD, MPH, discussed how primary care can support federal vaccine efforts, from participating in the national Vaccines for Children program to pre-ordering annual influenza and COVID-19 vaccines to eliciting questions patients and parents may have about vaccines.

Recent publications have reinforced the protective effects of vaccines against complications of measles, respiratory syncytial virus (RSV), and COVID-19. In an American Family Physician editorial, Dr. Doug Campos-Outcalt alerted family physicians to this year’s measles resurgence and its association with a small decline (95% to 93%) in the percentage of kindergarten-age children who have received two doses of measles, mumps, and rubella (MMR) vaccine. Measles is a highly contagious illness that is not free from complications, as some people believe:

Before the introduction of the measles vaccine in 1963, there were an estimated 3 million to 4 million cases of measles each year, leading to 48,000 hospitalizations, 1,000 cases of encephalitis, and 400 to 500 deaths.

Although not technically a vaccine, the monoclonal antibody nirsevimab was approved by the U.S. Food and Drug Administration in July 2023 for the prevention of RSV bronchiolitis in infants younger than 12 months. A prospective, matched case-control study examined the real-world effectiveness of nirsevimab in preventing hospitalization for RSV bronchiolitis in France during the 2023-2024 season, before that country’s implementation of maternal RSV vaccination. Nirsevimab was 83% protective against hospitalization for RSV-associated illness and reduced pediatric intensive care unit admissions by 70%.

COVID-19 vaccines have been shown to reduce the risk of infections and hospitalizations; however, there have been conflicting data about whether they are protective against postacute sequelae of SARS-CoV-2 (PASC, also known as long COVID). An analysis of a national primary care registry found that breathing difficulties, fatigue, and sleep disturbances often persist after having COVID-19. A large U.S. Department of Veterans Affairs case-control study showed that the rate of PASC decreased during the pre-Delta, Delta, and Omicron eras of COVID-19 and was significantly lower among vaccinated people after vaccines became available. Of the overall decrease in PASC, researchers estimated that 28% was attributable to viral changes and 72% attributable to vaccines.

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This post first appeared on the AFP Community Blog. Although it's hard to put a price on the suffering and deaths prevented by vaccines, an analysis published last week estimated that during the past 30 years in the U.S., childhood immunizations have produced a net savings of $540 billion in direct costs and $2.7 trillion in societal costs.

Saturday, August 3, 2024

The case for supporting more American immigrants, not less

As a senior faculty member at a medical school and now a residency program, I'm used to writing letters of recommendation (LOR) for students, residents, and junior faculty applying for promotions. A few years ago, I received a LOR request from a fellow (a physician who has completed residency and is pursuing specialized training) whom I'd never met before and who wasn't applying for faculty position or promotion. Instead, this foreign-born physician was applying to stay in the U.S. The reason he was asking me to support his application is that one of my papers had cited one of his research studies. As a "well-known physician and researcher in the field of Family Medicine," I could testify to the importance of his contribution to medical science in this country. He hoped to extend his visa in the EB-2 National Interest Waiver category, which requires that applicants "have an advanced degree or extraordinary ability and prove their work can significantly contribute to the US economy." I wrote the LOR, and though I did not hear back about the outcome, I recently Googled his name and was pleased to see that he was able to complete his training and is now an attending physician at a respected medical institution.

The contribution of international medical graduates (IMGs) to the U.S. physician workforce is, and has always been, substantial. My late grandfather (a neuropsychiatrist), uncle (an emergency medicine physician) and aunt (an ophthalmologist), all attended medical school in China before immigrating to the U.S. to teach and practice medicine. According to a recent article in JAMA, "there are currently more than 230,000 licensed IMGs who graduated from more than 2000 different medical schools in 169 countries." Some of these IMGs were immigrants like my relatives, while others were U.S. citizens who attended medical schools outside of the U.S. (most often in the Caribbean). Since U.S. medical school graduates tend to settle and practice in urban areas and enter higher-paying medical subspecialties, IMGs fill essential gaps in primary care and underserved rural areas - though a recent study suggested that fewer of them are choosing to do so.

This year's race for the Republican Presidential nomination, which concluded with the nomination of Donald Trump for the third election in a row, had the distinction of including two candidates who are the children of Indian immigrants: Nikki Haley and Vivek Ramaswamy. Both candidates, sensitive to the prevailing anti-immigrant sentiment in the GOP, were careful to note that their parents were "legal immigrants," presumably in contrast to the thousands of "illegals" migrating across the Mexican border. There are, of course, well-established pathways for highly educated foreign-born persons like their parents and mine to enter and remain in the U.S. That influx of talented doctors, scientists, engineers, and others is essential to maintaining America's technological preeminence.

But the U.S. doesn't just need highly educated professionals - it also needs factory laborers, construction workers, farm workers, nannies, housecleaners, and other working-class professions that don't qualify for EB-2 National Interest Waivers. Even if "mass deportation" of tens of millions of undocumented immigrants living in the U.S. was possible - and contrary to popular belief, the Biden administration expelled more migrants (2.8 million) during its first two years than Trump did during his entire 4-year term - it would result in wholesale economic disaster. What America needs isn't a way to get rid of more immigrants who are holding useful jobs and making our country better; instead, as I wrote ten years ago, it needs to create more legal pathways to citizenship that don't require a LOR from a professor of family medicine.

Monday, July 29, 2024

Despite recent study findings, jury is still out on screening ECGs

It’s not unusual for adult patients to undergo a 12-lead electrocardiography (ECG) during or soon after a preventive health visit. A 2017 analysis of administrative data in Ontario, Canada, found that more than 1 in 5 patients had an ECG within 30 days of a routine checkup. Unsurprisingly, patients with screening ECGs were more likely than others to receive additional cardiac tests, visits, or procedures. However, no significant differences in mortality, hospitalizations for cardiac reasons, or coronary revascularization between the groups were reported.

The U.S. Preventive Services Task Force (USPSTF) has consistently recommended against using ECG to screen for coronary heart disease in asymptomatic, low-risk adults. This recommendation was also included in the Choosing Wisely campaign. The rationale for not testing is that ECGs are unlikely to benefit these patients but can initiate harmful cascades of care. Nonetheless, research on the use of ECGs to identify patients with undiagnosed atrial fibrillation and other potentially serious abnormalities has continued. A 2019 report summarized previous studies that found associations between abnormal screening ECGs and worse cardiovascular outcomes after adjusting for traditional risk factors.

A recent study took advantage of the practice of performing ECGs as a mandatory part of annual health checks in Japanese adults 35 to 65 years of age. In the study, 3.7 million individuals with no history of cardiovascular disease or prior abnormal ECGs had an ECG in 2016 and were followed for a median of 5.5 years for the composite outcome of all-cause death or hospital admission for cardiovascular disease; 17% had one minor ECG abnormality, 4% had two or more minor abnormalities, and 1.5% had a major abnormality. Compared with people with normal ECGs, those with any ECG abnormality had a greater risk of experiencing the composite outcome.

In an accompanying commentary, former USPSTF member and family physician Alex Krist, MD, MPH, explained why these results probably will not change current recommendations:

For clinicians and patients, merely knowing that someone is at risk for an adverse event is not helpful without knowing what should be done to reduce that risk. There are multiple effective and recommended strategies to reduce people’s risk of CVD, including statin use for people at risk, screening for and managing hypertension, and counseling for healthy diet, exercise, and smoking cessation. Clinicians should routinely offer all of these preventive services to patients irrespective of whether their ECG result is normal or abnormal. Before recommending screening ECG, future studies will need to show that doing something different in response to an abnormal ECG changes a health outcome for a person.

A 2018 Lown Right Care article by Drs. Alan Roth, Andy Lazris, and Sarju Ganatra discussed overuse of cardiac tests in asymptomatic patients, including ECG, stress tests, and coronary artery calcium scoring.

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This post first appeared on the AFP Community Blog.

Saturday, July 13, 2024

Can large language models handle the complexity of family medicine?

Should family physicians be excited or apprehensive about the potential applications of artificial intelligence (AI) and large language models (LLMs) in primary care? An article by Dr. Richard Young and colleagues in the Journal of the American Board of Family Medicine recently made the case for both. Observing that primary care is a “complex adaptive system,” the authors suggested that AI “will likely work when its tasks are limited in scope, have clean data that are mostly linear and deterministic, and fit well into existing workflows.” On the other hand, AI may struggle to incorporate contextual and relational factors, process noisy and inaccurate data, or document vague symptoms that do not indicate a single disease condition.

In an editorial on chatbots and LLMs in the June 2024 issue of American Family Physician, Dr. Aaron Saguil discussed how family medicine practices are turning to LLMs to “help decrease administrative burden and combat burnout.” These tools can already compose visit notes, remotely monitor patients with interactive chats, and draft replies to patient portal messages.

In the future, LLMs may be integrated into electronic health records to provide real-time clinical decision support, suggesting “diagnostic possibilities, recommended ancillary evaluations, and possible treatment strategies.” To minimize the risks of LLMs propagating biased data, generating misinformation, or usurping the family physician’s role on health care teams, Dr. Saguil advised being actively involved in their implementation:

The best defense against AI risks becoming realities is conscientious physicians guiding the development and implementation of LLMs into clinical care settings, pointing out what LLMs can do and what they cannot. In family medicine, no LLM can yet address a complex patient in a unique sociocultural situation with overlapping comorbidities and health states from the vantage point of a longitudinal relationship.

A related FPM article by Dr. Steven Waldren, chief medical informatics officer at the American Academy of Family Physicians, explored other uses of LLMs in primary care, such as rewriting medical or legal forms for patients with lower health literacy or native languages other than English; summarizing information from a medical record, guideline, or research articles; drafting referral letters, prior authorization requests, and insurance appeals; and populating clinical registries. Dr. Waldren recommended three safeguards when using AI in medical practice: using LLMs only “when the physician or other user is able to easily verify the accuracy of the AI output”; not entering protected health or private organizational information in open online LLMs such as ChatGPT; and for now, using LLMs only in low-risk (nonclinical) situations. Echoing Dr. Saguil, Dr. Waldren called on family physicians to “weigh in on the design, development, and deployment of AI in medicine to ensure it is more helpful than harmful to patients, primary care physicians, and practices.”

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This post first appeared on the AFP Community Blog.

Monday, July 1, 2024

Clinical documentation and health inequities

Poor treatment by a clinician leads to suspicion of the motives of the health care system, increasing one’s reluctance to seek necessary care and the risk of a having an uncomfortable health care interaction in the future. For many patients—particularly those who identify with one or more racial, sexual, gender, and religious minority groups—this vicious cycle often leads to worse health outcomes.

A Lown Right Care article in the June 2024 issue of American Family Physician addresses the consequences of stigmatizing clinical documentation. In the case scenario, a patient feels stereotyped by his new primary care physician, who incorrectly describes him as African American (he self-identifies as Dominican Hispanic) and noncompliant for not filling a prescription or seeing a subspecialist he could not afford. Drs. Alan Roth and Andy Lazris explain how this language could negatively affect encounters with other clinicians:

Patients who identify as Black are more likely than those who identify as White to have comments using negative words or connotations in their history and physical documentation and may be subject to systemic bias in physicians' perceptions of their credibility.… The stigmatizing language used to describe patients in medical records can influence other clinicians and physicians-in-training in their attitudes toward the patient and their medication-prescribing behavior. This is an important and potentially damaging pathway by which bias can be propagated from one clinician to another.

In a previous AFP editorial, Drs. Megan Healy and Khameer Kidia presented several strategies to reduce bias and avoid stigmatizing language in medical records and other clinical communications. These strategies include not using labels, not blaming patients for their conditions, and not beginning presentations with race, ethnicity, language, socioeconomic status, or other social identifiers that may activate unconscious bias.

In 2021, a controversial JAMA social media post questioned the existence of structural racism and made the incredible claim that “no physician is racist.” This unfortunate episode contrasted with AFP’s active approach to advancing health equity, including sharing and promoting antiracist practices. Nonetheless, the medical profession has a long way to go to align its behaviors with its ideals. In a first-person narrative published in the New England Journal of Medicine, a Black health equity researcher visiting the emergency department receives callous treatment from two nurses and is mocked by a physician for suggesting that her area of expertise had something to do with the indifferent care she received. Making excuses for the health professionals involved (e.g., the emergency department was overcrowded, the nurses were tired and harried, the doctor was just having a bad day) amounts to being part of the problem. Instead, family physicians and other primary care clinicians can choose to be part of the solution to eliminating health inequities in kidney transplant, infertility care, skin conditions, asthma and lung diseases, cardiovascular disease, end-of-life care, and preventive care, among others.

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This post first appeared on the AFP Community Blog.

Tuesday, June 18, 2024

Contemplating colorectal cancer screening choices

Invitations to patients eligible for colorectal cancer screening need not be limited to office visits. A 2018 systematic review and meta-analysis of 73 randomized clinical trials of U.S.-based interventions found that mailing fecal tests more than doubled the likelihood that targeted patients received colorectal cancer screening. A recent trial in Clinical Gastroenterology and Hepatology compared screening completion in community health center patients randomly offered one of three options in an outreach mailing: colonoscopy referral only, fecal immunochemical test (FIT) only, or an active choice of colonoscopy or FIT. At 6 months, 12.8% of patients in the active choice arm had completed screening compared with 11.3% in the FIT-only arm and 5.6% in the colonoscopy-only arm.

As I discussed in a previous post, one problem with screening colonoscopy is that it is frequently repeated at shorter intervals than the recommended 10 years without a good reason. In fact, 10 years may not be long enough. A cohort study in JAMA Oncology suggested that a 15-year rescreening interval may be appropriate for average risk patients without a family history of colorectal cancer and with negative findings on their first screening colonoscopy. Using Swedish register-based data sources, researchers showed that individuals meeting these two criteria between 1990 and 2016 had 15-year standardized colorectal cancer incidence and mortality ratios that were lower than the 10-year cumulative risks in a matched control group.

A U.S. cross-sectional study that relied on data from the national Gastrointestinal Quality Improvement Consortium registry found that most patients with an episode of acute diverticulitis were not more likely to have colorectal cancer diagnosed on a follow-up colonoscopy than asymptomatic patients undergoing a screening colonoscopy. Only those with complicated diverticulitis (i.e., diverticulitis with perforation or abscess) were significantly more likely to have colorectal cancer (adjusted odds ratio = 3.57; 95% CI, 1.59 to 8.01).

Regarding the multitarget stool DNA (MT-sDNA) test for colorectal cancer screening, a study of 500 randomly selected patients in a Midwest health system found that about 1 in 5 had the test ordered inappropriately. The most common reasons for inappropriate ordering were having had a colonoscopy within the previous 10 years, having a family history of colorectal cancer, reporting symptoms suggestive of possible colorectal cancer, being younger than 45 years old, and having a previous diagnosis of adenomatous polyps.

A multitarget stool RNA (MT-sRNA) test with performance characteristics similar to those of the MT-sDNA test was approved in May 2024 by the U.S. Food and Drug Administration. Both tests are more sensitive for colorectal cancer and advanced adenomas than FIT but have lower specificity, resulting in higher false positive rates and more diagnostic colonoscopies. Of note, a research letter demonstrated that lowering the threshold for a positive FIT produced similar sensitivities and specificity as the MT-sRNA test, even without the RNA component of the test.

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This post first appeared on the AFP Community Blog.

Thursday, June 13, 2024

Canadian mammography kerfuffle echoes U.S. screening debate, 15 years later

In November 2009, I was a medical officer with the U.S. Preventive Services Task Force (USPSTF) at the Agency for Healthcare Research and Quality. The health reform legislation that would eventually become law as the Affordable Care Act (or "Obamacare" after then-president Obama) was being fiercely debated in Congress. Politicians who opposed expanding health insurance to the poor, self-employed, and employees of small businesses launched all sorts of spurious charges, the worst being that the law would establish "death panels" that would determine whether elderly patients with chronic medical conditions would be allowed to live or die. Into this political maelstrom stepped the USPSTF, releasing an ill-timed update that recommended against routinely screening women aged 40-49 for breast cancer. Contrary to popular belief, this language didn't mean they were advising all women in this age group NOT to be screened; instead, they were empowering patients to make this decision individually in consultation with their physicians, based on their preferences and values.

The current Task Force looked at essentially the same evidence and come to a different conclusion: start screening everybody at age 40, never mind the potential harms. In a Medscape commentary, I explained why I don't believe this change is justified. However, it put a great deal of pressure on our neighbors to the north and the Canadian Task Force on Preventive Health Care to reassess its recommendations and come to a similar conclusion. If Americans are getting screened for breast cancer in their 40s, why shouldn't Canadians too?

The Canadian Task Force released its draft recommendations two weeks ago. In short, they echo the USPSTF's recommendations in 2009 and 2016 and maintain that breast cancer screening should be a "personal choice," particularly for females younger than age 50. "For women aged 40 to 49, based on the current evidence (trials, observational studies, modelling and a review on values and preferences), we suggest not to systematically screen with mammography [emphasis mine]. Because individual values and preferences may differ, those who want to be screened after being informed of the benefits and harms should be offered screening every 2 to 3 years." The supporting data, much of it derived from systematic reviews, is extensive and compelling, including discussion tools for women in various age groups.

Unlike the U.S. 15 years ago, Canada isn't in the midst of a major health reform debate - they've already had an equitable universal health care system for decades, thank you very much. But that hasn't stopped one health official from trying to score cheap political points. The Canadian Minister of Health, Mark Holland, a lifelong politician without any health professions training, has forcefully objected to the CTFPHC's draft recommendations and ordered an unprecedented "external review" that will, no doubt, include conflicted experts such as radiologists who have obvious financial incentives to perform as many mammograms on asymptomatic women as possible.

Here is Holland being interviewed on an Ottawa news channel. When the anchor asks him what he would do if the external review confirms the Task Force's recommendations, he dodges and weaves and avoids answering.

As a former USPSTF member once said, "we can follow the evidence wherever it leads," or we can start with a preordained conclusion and cherry-pick data that supports what we already know to be true. Canada, Mark Holland, and the CTFPHC would do well not to mimic the most expensive, inequitable health care system in the world and associate higher percentages of women receiving mammography in their 40s with better preventive care "quality."

Tuesday, June 4, 2024

Why medications for AUD should be as popular as GLP-1 agonists for obesity

A recent commentary in the Journal of General Internal Medicine compared anti-obesity medications with medications for alcohol use disorder (AUD). Both chronic conditions are “characterized by behavioral patterns that pose risks of adverse health consequences” and “subject to societal stigma including … the idea that they reflect a lack of personal willpower.” While prescriptions for costly glucagon-like-peptide-1 (GLP-1) agonists for obesity such as semaglutide have skyrocketed, use of less expensive drugs for AUD remains low. The authors suggested that public perceptions that the latter are ineffective or unnecessary, implicit biases of clinicians, and delayed health benefits of alcohol cessation compared to weight loss contribute to the differences in use.

Given the magnitude of the problem, which worsened during the pandemic, an American College of Physicians policy brief advocated “training, payment, and delivery system policies to enable physicians and other qualified health professionals to screen, diagnose, and treat excessive alcohol use and AUD.” Recognizing patients with excessive alcohol use remains a challenge despite a U.S. Preventive Task Force recommendation to routinely screen adults, including pregnant patients, for unhealthy alcohol use and provide brief behavioral counseling interventions to persons engaged in risky or hazardous drinking.

A systematic review in JAMA’s Rational Clinical Examination series concluded that the Alcohol Use Disorders Identification Test (AUDIT) is most the useful tool for identifying AUD in adults and postpartum individuals, while the abbreviated AUDIT-Consumption (AUDIT-C) best identifies excessive alcohol use in children aged 9 to 18 years and older adults. Other studies have found that a single question alcohol screen (“How many times in the past year have you had five (men)/four (women) or more drinks in a day?”) is comparable to the AUDIT-C in detecting unhealthy alcohol use and current AUD in primary care.

Articles in the January 2024 and May 2024 issues of American Family Physician discussed FDA-approved and off-label pharmacotherapies for adults with AUD. According to an Agency for Healthcare Research and Quality review, oral naltrexone, acamprosate, and topiramate have the strongest evidence for reducing alcohol consumption, while injectable naltrexone, baclofen, and gabapentin have weaker supporting evidence. Of the two first-line treatments approved by the FDA for AUD, acamprosate is contraindicated in patients with a creatinine clearance of ≤ 30 mL/min, while naltrexone should be avoided in patients who use opioids or have advanced liver disease. Disulfiram is not more effective than placebo in reducing alcohol consumption.

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This post first appeared on the AFP Community Blog.

Friday, May 31, 2024

Measles outbreaks and the future of public health

In early March, a one year-old boy living in a shelter in Chicago was diagnosed with measles. Since measles is a highly contagious virus, more than 2000 shelter residents, many without confirmed histories of measles vaccination, were considered to be exposed. Over the next 3 days, the Chicago Department of Public Health (CDPH) swung into action, vaccinating 882 residents and confirming previous vaccination status in several hundred more, resulting in an estimated measles, mumps, and rubella (MMR) vaccine coverage of 93%. Nonetheless, in the next two months, 57 more cases of measles had been diagnosed among people residing in or having contact with residents of the shelter. A dynamic disease simulation model from the Centers for Disease Control and Prevention (CDC) estimated that in the absence of mass vaccination and case finding by CDPH, there was a 69% probability that this single infection would have led to more than 100 new measles cases.

The outlook for measles in the next decade in the U.S. is mixed, at best. Driven by the COVID-19 pandemic, vaccine skepticism and anti-vaccine sentiment has led to increases in religious and philosophical exemptions, causing the national kindergarten vaccination rate to fall to 93% in 2021-2022. Each percentage point decline increases the risk of a measles outbreak, as illustrated by the CDC's National Center for Immunization and Respiratory Diseases, with 93% MMR vaccination coverage associated with a 36% risk that a single infectious child could create an outbreak at a school with 100 children.

Unfortunately, decreasing childhood vaccination rates were not the only negative effect of the pandemic. The compelling PBS mini-series "The Invisible Shield" juxtaposes the historical successes of public health officials in controlling diseases and saving lives with the angry and occasionally violent pushback they received for ordering business closures and masking mandates to slow the spread of COVID-19. A recent Health Affairs article documented 112 judicial decisions from 2020-2023 that constrained public health's legal powers. As a result, the health commissioner for Columbus, Ohio was unable to close a daycare center where a measles case was reported in 2021, and a county in Michigan came close to shutting down the entire county health department over a dispute about masks.

An even bigger threat to public health is awaiting a decision from the Supreme Court:

On January 17, 2024, the US Supreme Court heard oral arguments in 2 combined cases, Loper Bright Enterprises v Raimondo and Relentless, Inc v Department of Commerce, that will determine the fate of Chevron deference, a bedrock principle of administrative law that obligates courts to defer to an agency’s reasonable interpretations of ambiguous statutes. ... Agencies like the FDA and CMS have, for decades, regulated medicine and public health in reliance of these principles.

If the Supreme Court decides that this deferential statutory framework is unconstitutional, it would effectively open every federal health regulation that does not derive directly from specific legislative language (the vast majority of thousands and thousands of regulations) to a lawsuit, and it would put the burden on a dysfunctional Congress to account for "all possible regulatory scenarios and unforeseen circumstances" in writing unambiguous legislation. This would be a disaster.

I wonder how federal and state governments would respond if public health actions became necessary to protect people from H5N1 ("bird flu"), which so far has only been confirmed in 3 dairy workers this year but has likely infected many more? So far H5N1 has only caused mild symptoms in humans, but the fact that this virus has spilled over from cows to people and little surveillance is being done in to track its spread in either population is worrisome.