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.

**

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.

**

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.

**

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."

**

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.