DEUS EX MACHINA REDUX

Similar to previous occasions, fiscal year 2023 was drawing to a close on September 30 as the prospects of producing legislation to avoid a federal government shutdown the next day appeared to be quite slim. Then, to the considerable surprise of many skeptics, House Speaker Kevin McCarthy (R-CA) yanked the proverbial rabbit out of a hat by bringing the bipartisan stopgap spending bill, H.R. 5860, to the floor. It passed 335-91, with 90 Republicans and one Democrat voting in opposition. The legislation made it possible to extend FY 2023 funding through November 17 in the new fiscal year beginning October 1. Next, on a vote of 88-9, the Senate accepted the House version of the bill even though it eliminated funding for Ukraine and a provision that would raise the amount of pay for Members of Congress. Late September 30, President Joseph Biden signed the measure into law.  

Unfortunately for Representative McCarthy, those 90 Republicans in opposition included eight members of a conservative group known as the Freedom Caucus in his political party who swiftly took action to remove him from his position as Speaker. Almost immediately, he faced a motion to vacate the chair. Headed by Representative Matt Gaetz (R-FL), they opposed a bipartisan approach to government funding and sought to enact steep budgetary cuts. They blamed the Speaker for failing to achieve these more desirable outcomes. He was ousted on a 216-210 vote that included those eight members. 

For the nonce, Representative Patrick McHenry (R-NC) will serve as speaker pro tempore until the Republican conference decides whom to select as a permanent replacement to fill the vacated position. Presently, it is unclear if he has enough support from that conference to begin negotiations with the Senate regarding 12 major appropriation bills awaiting enactment. Thus far, the House has passed four of those spending bills while the Senate Appropriations Committee has approved all 12 of them, but none has passed the full Senate. 

Congress often is criticized for being too polarized. Yet, legislative progress continues to take place regarding other matters that are important. As an illustration, all too often in the health domain insufficient attention is paid to prominent health workforce concerns. The Senate Health, Education, Labor and Pensions (HELP) Committee advanced a bipartisan primary care and health care workforce package (S. 2840) on September 21 by a vote of 14-7. Chairman Bernie Sanders (I-VT) joined forces with Senator Roger Marshall (R-KS) as co-authors of this bill. Senators Mike Braun (R-IN) and Lisa Murkowski (R-AK) combined with Committee Democrats in support of the measure. The Bipartisan Primary Care and Health Workforce Act includes nearly a $2 billion annual increase in mandatory funding for community health centers. The total will be $5.8 billion annually over a three-year period. Mandatory funding for the National Health Service Corps would be tripled from $310 million to $950 million annually for three years. If enacted, another beneficiary would be the provision of $1.5 million in mandatory funding over the next five years for the Teaching Health Centers Graduate Medical Education program.  

SORITES PARADOX IN HEALTH CARE DELIVERY OVERUSE AND UNDERUSE

A proposition is advanced that health care around the globe suffers from both underuse (undertreatment and undertesting) and overuse (overtreatment and overtesting) that have persisted for decades. Studies have identified many drivers of suboptimal care, generally classified into three categories: (a) economic incentives affecting clinician behavior; (b) professional knowledge, bias, the uncertainty inherent in clinical decision-making; and (c) failure to include patients to capitalize on the power of human relationships. Nonetheless, these drivers only partially explain the persistence of suboptimal use. In a paper appearing in the September 2023 issue of the Journal of Evaluation in Clinical Practice, an argument is proposed that overuse and underuse of services are an inherent consequence of the nature of the relationship between scientific evidence and decision-making. Evidence about diagnosis or health outcomes exists on the probability continuum (from impossibility to virtual certainty), while decisions are categorical (e.g., treatment is or is not recommended).  

For example, risk for heart disease can range from close to zero (young, healthy individuals) to 100% when clinically manifested as myocardial infarction. To help reduce risk of heart disease, the American College of Cardiology and American Heart Association (ACC/AHA) recommend that treatment is warranted if the risk ≥7.5% over 10 years. If the estimated risk is below this threshold, treatment should not be recommended. Doing so would reflect overuse/overtreatment. Conversely, not recommending treatment would constitute underuse/undertreatment. So, why not administer statins at 7.4% (or, 7.3%, 7.2% … 0.01%)? The problem relates to an ancient epistemological puzzle called the Sorites paradox, also known as “little-by-little arguments.” Sorites in the Greek language means heap while paradox reflects challenges in defining clear boundaries between borderline cases of the quantities of interest. At which point does the collection of grains become large enough to be called a heap and small enough to be classified as a few scattered grains of sand? The Sorites paradox abounds. Because clinicians use scientific evidence (that exists on a continuum) but make categorical (yes/no) decisions based on numerical thresholds, the Sorites paradox is unavoidable in practice. A possible approach to a solution is to apply threshold decision models, which the authors discuss.

OBTAINABLE RESOURCES

WHO Traditional Medicine Global Summit 2023 

The first WHO Traditional Medicine Global Summit  “Towards health and well-being for all” was held in Gandhinagar, Gujarat, India, on 17-18 August 2023, to look anew at the application of rigorous scientific methods to unlock the vast potential of traditional, complementary, and integrative medicine (TCIM) amidst important challenges and opportunities to realize universal health coverage and promote health and well-being for individuals and the planet. Participants in the Summit, coming from all WHO regions, included a range of stakeholders: from health and TCIM practitioners; civil society representatives and Indigenous Peoples; to health policy and decision-makers and government officials from the G20 and other countries. Based on the research and evidence-informed discussions and initiatives presented in the Summit’s five plenary and six parallel sessions, participants endorsed the outcomes of the Summit in a meeting report: The Gujarat Declaration. The document sets out an action agenda towards the implementation of evidence-based TCIM interventions and approaches in support of the goal of universal health coverage and health-related Sustainable Development Goals, among others, and the application of science, technology, innovation, and knowledge exchange to validate and unlock, as appropriate, the contribution of TCIM and Indigenous knowledge to advance planetary health and individual health and well-being across the life course. The Gujarat Declaration Report can be obtained here.

New Rural Initiative Focuses On Age-Friendly Care 

The National Rural Health Association (NRHA) released an an article in Rural Horizons entitled, “New NRHA Initiative Focuses on Age-Friendly Care.” This initiative will help providers offer comprehensive age-friendly care to one in five older adults living in rural areas. These individuals face unique concerns not shared by their urban counterparts. Issues such as traveling farther distances, fewer community spaces, hospital closures, and health care provider shortages have left rural older adults at higher risk for worsening health outcomes. The article can be obtained here.

Imagining The Future Of Postsecondary Education 

Postsecondary education is in a unique moment ripe for reinvention. Members of young age groups are reexamining the value of a college degree as enrollment declines, survey data show Americans have less faith in a four-year degree, and concerns about college debt are widespread. Employers are hungry for talent, especially since the “Great Resignation,” when large numbers of workers quit their jobs following the onset of the COVID-19 pandemic. This environment has created new leverage for workers as support for unions and demands for better pay and working conditions have increased and some employers have reexamined degree requirements. The Urban Institute hosted a two-day workshop in early June 2023 to reimagine the future of postsecondary education so everyone can access a high-quality and affordable education that prepares them for good jobs. Workshop participants included representatives from education, government, research, philanthropy, and business. Together they worked to generate ideas for imagining a more equitable future through postsecondary education, including how to support learners at all points on their education journey through two-generation strategies, robust navigation, effective use of technology, development of a skills infrastructure, and cross-cutting investments to close racial wealth gaps. A workshop report contains the questions that were considered and five interrelated ideas that emerged. The document can be obtained here.

DEVELOPMENTS IN HIGHER EDUCATION

The Biden Administration on August 22, 2023 announced that it has fully launched its updated income-driven repayment application tool on StudentAid.gov, making it possible for student loan borrowers to  enroll in the Saving on A Valuable Education (SAVE) plan. This initiative is part of the Administration’s broader efforts to make college more affordable and to support students and borrowers. The Administration already has approved the cancellation of more than $116 billion in student loan debt for 3.4 million borrowers. The new SAVE plan is expected to provide relief of millions of borrowers money on their monthly payments. 

Additionally, the U.S. Department of Education is announcing a nationwide outreach campaign called “SAVE on Student Debt” in collaboration with leading grass roots organizations. The aim is to leverage strategic partnerships across public, private, and nonprofit sectors to support borrowers by ensuring they take full advantage of the benefits provided by the SAVE plan in addition to the existing resources and debt forgiveness programs available from the Department. 

Under the SAVE plan, a single borrower who makes less than $15 an hour will not have to make any payments. Borrowers earning above that amount would save more than $1,000 a year on their payments compared to other income-driven repayment (IDR) plans. The SAVE plan also ensures that borrowers never see their balance grow due to unpaid interest as long as they keep up with their required payments.

Nominations Solicited For Negotiators To Participate In Public Rulemaking Sessions

The Biden Administration on August 29, 2023 announced the next step in its efforts to open a new pathway to student debt relief by soliciting nominations for negotiators who will participate in public rulemaking negotiation sessions this Fall. The Department of Education seeks nominations from 14 different constituency groups for the Student Loan Relief committee, which will meet for three virtual sessions beginning October 10. Nominations represent the second step in a process known as “negotiated rulemaking,” which is required under the Higher Education Act for any regulations related to the Federal student financial aid programs.  

This process started with a public hearing held by the Department last July 18 and a request for public comments, which solicited more than 24,000 responses. Next, negotiators selected by the Department will meet virtually on October 10-11, November 6-7, and December 11-12 to discuss ideas for regulatory reform. The Department is seeking negotiators representing the following categories, each of which will include a primary and alternate representative: 

· Four spots for current students and student loan borrowers based upon the level of program attended. The Department is particularly interested in a variety of experiences with student loans and postsecondary education, including attending different types of institutions, receiving a Pell Grant, and borrowing a Parent PLUS loan.

· Four spots for different types of institutions of higher education, including Historically Black Colleges and Universities and minority serving institutions.

· Two spots for State officials and Attorneys General.

· Two spots for civil rights organizations and legal assistance organizations.

· One spot for a U.S. military service member or veteran.

· One spot for a representative from the Federal Family Education Loan program. 

The Department will publish proposed rules for the public to comment on in the months following the conclusion of negotiations. Nominations can be sent to negregnominations@ed.gov and must include clear information about nominees. Nominations must be received by September 14, 2023. Additional details on requirements for nominees can be obtained here.

CAPITOL HILL ACTIVITIES

Now that the August recess period for members of congress has ended, September is expected to be characterized by strenuous efforts in both chambers to produce 12 appropriation bills for the next fiscal year that begins on October 1, 2023. Although no legislation has been passed yet in the Senate, the Appropriations Committee was able to complete work on all 12 annual spending bills, where they received bipartisan support. Over in the House, the Military Spending-Veterans Affairs bill passed, but it is expected that progress on the other 11 appropriation bills will be significantly more challenging to achieve. An expectation is that agreement may be reached by the two chambers to have a continuing resolution go into effect that will allow funding to continue until the end of this calendar year at FY 2023 spending levels. 

On a separate related note, the Federal Pell Grant program, authorized by Title IV of the Higher Education Act (HEA), is the single largest source of federal grant aid supporting postsecondary education students. Congress and stakeholders in the higher education and workforce training communities for several years have promoted the possibility of expanding these grants to students enrolled in short-term programs that do not meet the minimum durational requirements in current law. A possible expansion would be intended to provide prospective students with more educational and career options and employers with more skilled applicants. Concerns about a possible expansion generally are related to historical fraud perpetrated by providers of short-term programs and inconsistent employment returns for short-term offerings.  

According to a report issued on August 24 of this year by the Congressional Research Service, generally, undergraduate degree programs and certificate programs of at least 600 clock hours of instruction (or the equivalent) offered over a minimum of at least 15 weeks are eligible. Title IV-participating institutions of higher education must be authorized to operate a postsecondary educational program by the state in which they are located, approved by an accrediting agency recognized by the U.S. Department of Education, and certified by the Department. As of August 2023, three major bills have been introduced in the 118th Congress to expand Pell Grants to short-term programs: 

· Promoting Employment and Lifelong Learning Act (PELL Act; H.R. 496).

· Jobs to Compete Act (H.R. 1655).

· Jumpstart Our Businesses by Supporting Students Act (JOBS Act; S. 161) and its companion, the JOBS Act of 2023 (H.R. 793).  

The bills share several provisions. Short-term programs would be defined as educational offerings providing 150-599 clock hours of instruction offered over 8-14 weeks. The programs would have to be in in-demand industries. Student eligibility would be expanded to otherwise Pell-eligible students who have received a bachelor’s degree, but not a postbaccalaureate degree.

U.S. LIFE EXPECTANCY GAP WIDENS

Now that competition for the next U.S. presidential election cycle has begun heating up, it is common to hear candidates boast that this nation is the greatest on earth. That claim often is perceived as being true in the aggregate, but there also is some value in taking into account certain qualifiers, such as life expectancy trends. The September 2023 issue of the American Journal of Public Health contains several items regarding this particular topic. 

One point of view is that the United States suffers from a health disadvantage. The U.S. population experiences poorer health than populations in other countries and the disadvantage has grown over time. A component of this phenomenon is the U.S. life expectancy disadvantage. Survival in the developed world has increased over the past century, but growth in this country’s life expectancy has not kept pace with that of other industrialized countries. Moreover, the gap with other nations widened dramatically after 2010, when life expectancy plateaued here, but continued increasing elsewhere. 

A recent demonstration of the U.S. health disadvantage occurred during the COVID-19 pandemic, when the United States experienced more deaths from this disease than any other country and had among the highest per capita death rates. U.S. life expectancy decreased by 2.1 years between 2019 and 2021, the largest decline in a century. Other high-income countries experienced smaller decreases in life expectancy during the pandemic, widening the gap to historic levels. The U.S. life expectancy disadvantage began decades ago, but exactly when remains unclear. Studies typically date the onset to the 1980s or 1990s, raising intriguing research questions about events in history that might explain this timing.  

Researchers usually measure the U.S. life expectancy gap in reference to “peer countries,” typically selecting high-income—and largely Western European or Anglo-Saxon—countries as the comparison group. The implicit assumption is that less affluent or developing countries are unlikely to outperform the United States and cannot serve as a benchmark for documenting a U.S. disadvantage. The validity of either assumption—that only high-income countries surpassed the United States and that the phenomenon began in the 1980s to 1990s—is unclear. 

A 2013 National Research Council report explored five domains that might explain the U.S. health disadvantage—health systems, individual behaviors, socioeconomic factors, the environment, and policies and social values—and with each domain found distinctive U.S. characteristics that might contribute to poorer health. Potential contributors included not only downstream, proximal factors, such as obesity, substance abuse, and deficiencies in the U.S. health care system, but also upstream, macrostructural factors, such as U.S. policies. For example, countries with better health outcomes typically offer more generous social welfare and income support programs and enforce stronger regulations to protect public health and safety. Going forward, a prudent first step could be to examine policies that have enabled other countries to outperform the United States for decades.

QUICK STAT (SHORT, TIMELY, AND TOPICAL)

National Estimates Of Gender-Affirming Surgery In The U.S.

Trends in inpatient and outpatient gender-affirming surgery (GAS) procedures in the U.S. and in the types of GAS performed across age groups are of interest. As reported on August 23, 2023 in JAMA Network Open, a total of 48,019 patients who underwent GAS were identified, including 25,099 (52.3%) who were aged 19 to 30 years. The most common procedures involved the breast and chest, which occurred in 27,187 patients (56.6%), followed by genital reconstruction (16,872 [35.1%]) and other facial and cosmetic procedures (6,669 [13.9%]). The absolute number of GAS procedures rose from 4,552 in 2016 to a peak of 13,011 in 2019 and then declined slightly to 12,818 in 2020. Overall, 25,099 patients (52.3%) were aged 19 to 30 years, 10,476 (21.8%) were aged 31 to 40, and 3,678 (7.7%) were aged 12 to 18 years. When stratified by the type of procedure performed, breast and chest procedures made up a greater percentage of the surgical interventions in younger patients, while genital surgical procedures were greater in older patients. 

Nonfatal And Fatal Falls Among Adults Aged ≥65 Years—United States, 2020–2021

Unintentional falls in the U.S. are the leading cause of injury and injury death among adults aged ≥65 years (older adults). Patterns of nonfatal and fatal falls differ by sex and state. According to the September 1, 2023 issue of Morbidity And Mortality Weekly Report, data from the 2020 Behavioral Risk Factor Surveillance System and 2021 National Vital Statistics System were used to ascertain the percentage of older adults who reported falling during the previous year and unintentional fall-related death rates among older adults. In 2020, 14 million (27.6%) older adults reported falling during the previous year. The percentage of women who reported falling (28.9%) was higher than that among men (26.1%). The percentage of older adults who reported falling ranged from 19.9% (Illinois) to 38.0% (Alaska). In 2021, 38,742 (78.0 per 100,000 population) older adults died as the result of unintentional falls. The fall–related death rate ranged from 30.7 per 100,000 population in Alabama to 176.5 in Wisconsin.  

HEALTH TECHNOLOGY CORNER 

Exercise Test Predicts Both Noncardiovascular And Cardiovascular Death

The treadmill exercise test with electrocardiogram (ECG) typically focuses on diagnosing coronary artery disease. A study from the Mayo Clinic described in the September 2023 issue of the journal Mayo Clinic Proceedings finds that exercise test abnormalities, such as low functional aerobic capacity, predicted non-cardiovascular causes of death such as cancer in addition to cardiovascular-related deaths. The investigation  looked at 13,382 patients who had no baseline cardiovascular issues or other serious diseases and who had completed exercise tests at the Mayo Clinic between 1993 and 2010, then were followed closely for a median period of 12.7 years. The principal new finding is that noncardiovascular (CV) deaths predominate in a primary prevention cohort in absence of significant baseline CV disease. The findings suggest that clinicians should focus not only on ECG results, but on data in the exercise test results, such as low functional aerobic capacity, low chronotropic index, and abnormal heart rate recovery. 

Menopause—Biology, Consequences, Supportive Care, And Therapeutic Options

A review published on September 6, 2023 in the journal Cell summarizes the biology and consequences of menopause, the role of supportive care, and the menopause-specific therapeutic options available to women. Optimizing health at menopause is the gateway to healthy aging for women. Although not all women will experience bothersome menopause-related symptoms, the silent effects of the menopause transition may be substantial, such as bone loss increasing future fragility fracture risk and adverse effects on blood lipids and cardiometabolic disease risk. Thus, all women should have access to a general health assessment at the time of menopause transition to maximize their physical well-being, including their cardiometabolic and musculoskeletal health, and their psychological and sexual well-being. Women with bothersome menopausal symptoms should be counseled on treatment options and offered evidence-based therapies, such as menopausal hormone therapy (MHT).

THE ROLE OF SOCIAL DETERMINANTS OF HEALTH

As discussed in the July 4, 2023 issue of the Journal of the American Heart Association, cardiovascular disease (CVD) is the leading cause of mortality worldwide. Addressing social determinants of health (SDoH) may be the next forefront of reducing the enormous burden of CVD. SDoH can be defined as any social, economic, or environmental factor that influences a health outcome. An umbrella review sought to give a comprehensive overview of the role of SDoH in CVD. Four themes (economic circumstances, social/community context, early childhood development, and neighborhood/built environment) and health literacy in the health/health care theme were considered. Despite the quality of the included reviews being low or critically low, there was consistent evidence that factors relating to economic circumstances and early childhood development themes were associated with an increased risk of CVD and CVD mortality. Factors in the social/community context and neighborhood/built environment themes, such as social isolation, fewer social roles, loneliness, discrimination, ethnicity, neighborhood socioeconomic status, violence, and environmental attributes had a role in CVD.  

Apart from clinical interventions, there is a need to strengthen nonmedical interventions that address multiple factors simultaneously. A possible way of doing so addressed in the June 2023 issue of the journal The Milbank Quarterly is to expand the cadre of effective SDoH mitigation strategies. A practical, heuristic framework for policy makers, practitioners, and researchers is needed that serves as a roadmap for conceptualizing and targeting the key mechanisms of SDoH influence. A synthesis of the extant SDoH research into a heuristic framework addresses a scarcity of peer-reviewed organizing frameworks of SDoH mechanisms designed to inform practice. Development of such a framework represents a practical tool to facilitate the translation of scholarly SDoH work into evidence-based and targeted policy and programming. Tools designed to close the research-to-practice translation gap for effective SDoH mitigation are sorely needed.  

DEVASTATING CLINICAL CONSEQUENCES OF CHILD ABUSE AND NEGLECT

A companion to the aforementioned consideration of social determinants of health is to take into account the especially baneful clinical consequences of child abuse and neglect. It is well established that maltreatment of children under the age of 18 can be devastating. According to the August 2023 issue of the American Journal of Psychiatry, over the past two decades research has begun not only to define the consequences in the context of health and disease, but also to elucidate mechanisms underlying the link between childhood maltreatment and medical, including psychiatric, outcomes. Research has begun to shed light on how this maltreatment mediates disease risk and course. Childhood maltreatment increases risk for developing psychiatric disorders (e.g., mood and anxiety disorders; posttraumatic stress disorder (PTSD); antisocial and borderline personality disorders; and substance use disorders). Child abuse is associated with an earlier age at onset and a more severe clinical course (i.e., greater symptom severity) and poorer treatment response to pharmacotherapy or psychotherapy. Early-life adversity also is associated with increased vulnerability to several major medical disorders, including coronary artery disease and myocardial infarction; cerebrovascular disease and stroke; type 2 diabetes; asthma; and certain forms of cancer.  

It is estimated that one in four children will experience child abuse or neglect at some point in their lifetime, and one in seven children have experienced abuse over the past year. Also, it is widely accepted that statistics on such reports represent a significant underestimate of the prevalence of childhood maltreatment because the majority of abuse and neglect goes unreported. The situation especially is true for certain types of childhood maltreatment (notably emotional abuse and neglect), which may never come to clinical attention, but have serious impacts on health independently of physical abuse and neglect or sexual abuse. Studies converge on and consistently support the finding that childhood maltreatment increases disease vulnerability for mood disorders, as well as a more pernicious disease course. A reduction in the prevalence of childhood maltreatment would have a substantial impact on decreasing disease burden. Investigations suggesting modifiable targets are only just beginning to emerge and point to behavioral and environmental factors that could be focused on for early interventions. 

REACHING AGREEMENT ON FEDERAL SPENDING

Members of Congress are in their August recess period. Senators expect to reconvene on September 5 while members of the House of Representatives will do likewise on September 12. Once they return, they must face the arduous task of reaching agreement on the amount of spending for 12 appropriation bills for the new fiscal year that begins on October 1. Major differences presently exist between Democrats and Republicans, especially on non-military kinds of expenditures. 

Thus far, work in the Senate has proceeded more smoothly. No bills have been passed yet, but it is significant that the Appropriations Committee in that chamber already has completed work on all 12 annual spending bills, where they received bipartisan support. For example, the Committee approved on a vote of 26-2, its fiscal year (FY) 2024 Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) spending bill that includes $224.4 billion in funding, a roughly $14.5 billion increase. The National Institutes of Health would receive $47.7 billion, which represents a net increase of $265 million (0.6%) over the comparable FY 2023 funding level. The U.S. Department of Health and Human Services Department (HHS) would receive $117 billion, which includes a $250 increase in the maximum Pell Grant award. Each year, this form of assistance helps more than six million students at all stages of life pursue post-secondary education and further their careers. 

The Military Spending-Veterans Affairs bill passed in the House, but it is expected that more unwieldy patterns will characterize efforts to reach agreement on the other 11 appropriation bills. For example, despite objections by Democrats, the House Labor, Health and Human Services, Education, and Related Agencies Appropriations Subcommittee on July 14 approved by voice vote a draft FY 2024 spending bill that would reduce by $60.3 billion (29%) funding for several agencies and programs within the Departments of Health and Human Services (HHS), Education, and Labor. Just as significantly, the Agency for Healthcare Research and Quality and several programs within the Centers for Disease Control and Prevention would be eliminated. 

The situation is somewhat different in 2023 because earlier this year it was necessary for Congress to reach agreement on how to avert a default on the nation’s debt. The result is that federal spending on domestic programs must be flat for FY 2024. Unless the House and Senate are able to pass all 12 appropriations bills before Jan. 1, 2024, the earlier budget agreement will result in a forced 1% percent cut to all agencies. A sub-group of Republican members called the Freedom Caucus favors major spending reductions across a vast range of programs. Democrats are opposed and since they are a majority in the Senate, the two chambers are on a collision course. If unable to pass all 12 spending bills by September 30, short term measures will have to be implemented to enable the government to continue functioning.   

ARTIFICIAL INTELLIGENCE AND GPT

As explained in the July 2023 issue of the journal Trends in Cognitive Sciences, artificial intelligence (AI) is an “agent of replacement” designed to take over tasks once performed by humans. Generative large language models, such as GPT are replacing much human labor, including in psychological science, where researchers use these tools to help edit papers, conduct literature reviews, and create scale items. A provocative question worth considering is “Could AI replace human participants?” For that replacement to occur, AI must give humanlike responses. The “humanness” of AI has long been questioned.  

As described in the July 20, 2023 issue of the journal Nature, two scientists produced a research paper in less than an hour with the help of ChatGPT, a tool driven by AI that can understand and generate human-like text. The researchers designed a software package that automatically fed prompts to ChatGPT and built on its responses to refine the paper over time. This autonomous data-to-paper system led the chatbot through a step-by-step process that mirrors the scientific process, from initial data exploration; through writing data analysis code and interpreting the results; to writing a polished manuscript. The article was fluent, insightful, and presented in the expected structure for a scientific paper, but the effort was not perfect. For instance, it states that the study “addresses a gap in the literature,” a phrase that is common in manuscripts, but inaccurate in this case. 

While AI shows promise for improving basic and translational science, medicine, and public health, its success is not guaranteed as described in the July 20 issue of the journal Science. Numerous examples have arisen of racial, ethnic, gender, disability, and other biases in AI applications to health care. Consensus has emerged among scientists, ethicists, and policy makers that minimizing bias is a shared responsibility among all involved in AI development. Ensuring equity will require more than unbiased data and algorithms. It also will entail reducing biases in how clinicians and patients use AI-based algorithms, a potentially more challenging task than reducing biases in algorithms themselves.  

Allied health consists of several professions described under that umbrella term. The August 3, 2023 issue of the New England Journal of Medicine contains a paper acknowledging that medical trainees and clinicians already use AI, which means that medical education does not have the luxury of watchful waiting. The field needs to grapple now with the effects of AI. Many valid concerns already have been raised about AI’s effects on medicine, including the propensity for AI to make up information that it then presents as fact (termed a “hallucination”), its implications for patient privacy, and the risk of biases being baked into source data.  A major concern is the ways in which this technology could affect the thought structures and practice patterns of medical trainees and physicians for generations to come. Such issues have implications for many other professions, including allied health. More information on this overall topic will be available at the 2023 ASAHP Annual Conference on October 17-19 in Fort Lauderdale, FL. 

USE OF STORY TELLING IN SCIENCE AND HEALTH COMMUNICATION

Many individuals deny science and reject health recommendations despite widely distributed facts and data. According to an article in the July 2023 issue of the journal Patient Education and Counseling, an unwarranted rejection of science is estimated to occur in over one-fourth of residents in western, industrialized countries. It is often rooted in “religiosity and political orientation; morality; and science understanding.” Various factors lead to skepticism in a wide variety of topics, including vaccine safety and efficacy; medication adherence; the creation/age of the universe; climate change; genetically modified foods; and individual and community public health measures to reduce infections and prevent outbreaks of disease. Skepticism manifests as fear, disbelief, mistrust in motivation, and suspicion of hidden or manipulative agendas. Politicization of the COVID-19 pandemic is viewed as emboldening science denial and rejection of medical and public health advice. As described in this issue of the aforementioned periodical, a study explored the impact and appeal of using narrative (storytelling) versus didactic methods in science and health communication.  

The investigators found that narrative science/health communication is effective and appealing for audiences across a variety of topics and mediums, with supporting evidence across fields, such as epidemiology, neuroscience, and psychology. Whether narrative or didactic messaging is most effective depends on the topic, audience, and objective, as well as message quality. Combining narrative with didactic methods is likely to be more effective, however, than using either strategy alone. The researchers posit that science and health communicators should collaborate with cultural and storytelling experts; work directly with their target audiences throughout the message development and testing processes; and rely on popular story elements (e.g., first-person point of view, relatable protagonists) to improve the comprehension, engagement, and thoughtful consideration of their intended audience. Didactic science and health communication often can be dry, relying on the false assumption that individuals make purely evidence-based decisions. Stories can be a powerful teaching tool by capturing attention and evoking emotion.

DEVELOPMENTS IN HIGHER EDUCATION

The National Advisory Committee on Institutional Quality and Integrity, U.S. Department of Education held its Winter 2023 meeting from February 28 to March 2. Committee members raised various questions and concerns about the processes and policies of accreditor recognition. During the discussion, the         establishment of a subcommittee was proposed to explore and report back on various topics. During the subsequent four months, this subcommittee quickly agreed on the topics on which to focus, drafted issue papers, sought input from Department staff, and discussed the topics at several meetings. The group  also reached out to institutional accreditors, including both former regional and national accreditors,     programmatic accreditors, faith-based accreditors, and consumer representatives to seek their thoughts on policy areas of interest. A report was prepared that included the following topics: accreditor complaint   policies, the federal link, public members, and outcomes/student achievement.

Each item was discussed from the perspective of: Concerns and Recommendations. For example, a       Concern regarding outcomes/student achievement is that rather than requiring the accrediting agency to “assess” an institution’s success – as required by the statute – the regulations simply require the             accrediting agency to “set forth clear expectations.” The regulation’s wording anticipates no follow-up by agencies on the question of whether expectations were met. (The change from “assess” to “set forth…” could be a violation of the prohibition on regulations regarding the standards). A Recommendation is that the regulations should be amended to mirror the statutory requirement that an accrediting agency’s      standards “assess” institutions, in addition to setting clear expectations. The Subcommittee believes a    simple and clear way to make both the statute and regulation more effective would be to better clarify what it means for an agency to have a standard (or standards) that “assess” an institution’s success with regard to student achievement. The report can be obtained at https://sites.ed.gov/naciqi/files/2023/07/Regulations-Subcommittee-Draft-Report_Final_2023-07-17-004.pdf.

National Postsecondary Student Aid Study

A report issued by the U.S. Department of Education in July 2023 represents a First Look at Student      Financial Aid Estimates for 2019–20. The most comprehensive national study of student financing of postsecondary education in the United States, the document includes information for about 80,800 undergraduate students and 19,700 graduate students attending 2,200 postsecondary institutions in the 50 states, the District of Columbia, and Puerto Rico. This report also describes the percentages of students receiving   various types of financial aid and average amounts received, by type of institution attended, gender, race/ethnicity, attendance pattern, and income level. Percentages and average amounts additionally are          described by dependency status for undergraduate students and by graduate program for graduate students. Supplemental tables feature state-level percentages of students receiving aid and average amounts received by undergraduate students. The report is available at https://nces.ed.gov/pubs2023/2023466.pdf. 

Proposed Regulations On Distance Education And State Authorization

The American Council on Education on July 18, 2023 in collaboration with the Presidents Forum hosted a discussion on Capitol Hill to examine the Department of Education’s (ED) draft regulations regarding   distance education and state authorization. Panelists explored how ED’s proposed rules to upend the      current state reciprocity agreement would create challenges for institutions offering distance education courses and their students, while also discussing a better way forward. As part of a more than 1,000 page draft rule released in May 2023, ED proposed undoing the state reciprocity agreement by requiring institutions to meet all state consumer protection laws related to recruitment, closure, and misrepresentation where distance education is offered, regardless of National Council for State Authorization Reciprocity Agreements (NC-SARA) participation. Forty-nine states participate in NC-SARA, a voluntary agreement that provides national standards for interstate postsecondary distance education. The Association of Schools of Advancing Health Professions (ASAHP) joined with other organizations in sending a letter to the ED Secretary on June 20, 2023 warning that some of the department’s proposals would be problematic. 

DEVELOPMENTS IN HIGHER EDUCATION

The National Advisory Committee on Institutional Quality and Integrity, U.S. Department of Education held its Winter 2023 meeting from February 28 to March 2. Committee members raised various questions and concerns about the processes and policies of accreditor recognition. During the discussion, the         establishment of a subcommittee was proposed to explore and report back on various topics. During the subsequent four months, this subcommittee quickly agreed on the topics on which to focus, drafted issue papers, sought input from Department staff, and discussed the topics at several meetings. The group  also reached out to institutional accreditors, including both former regional and national accreditors,     programmatic accreditors, faith-based accreditors, and consumer representatives to seek their thoughts on policy areas of interest. A report was prepared that included the following topics: accreditor complaint   policies, the federal link, public members, and outcomes/student achievement.  

Each item was discussed from the perspective of: Concerns and Recommendations. For example, a       Concern regarding outcomes/student achievement is that rather than requiring the accrediting agency to “assess” an institution’s success – as required by the statute – the regulations simply require the             accrediting agency to “set forth clear expectations.” The regulation’s wording anticipates no follow-up by agencies on the question of whether expectations were met. (The change from “assess” to “set forth…” could be a violation of the prohibition on regulations regarding the standards). A Recommendation is that the regulations should be amended to mirror the statutory requirement that an accrediting agency’s      standards “assess” institutions, in addition to setting clear expectations. The Subcommittee believes a    simple and clear way to make both the statute and regulation more effective would be to better clarify what it means for an agency to have a standard (or standards) that “assess” an institution’s success with regard to student achievement. The report can be obtained at https://sites.ed.gov/naciqi/files/2023/07/Regulations-Subcommittee-Draft-Report_Final_2023-07-17-004.pdf. 

National Postsecondary Student Aid Study

A report issued by the U.S. Department of Education in July 2023 represents a First Look at Student      Financial Aid Estimates for 2019–20. The most comprehensive national study of student financing of postsecondary education in the United States, the document includes information for about 80,800 undergraduate students and 19,700 graduate students attending 2,200 postsecondary institutions in the 50 states, the District of Columbia, and Puerto Rico. This report also describes the percentages of students receiving   various types of financial aid and average amounts received, by type of institution attended, gender, race/ethnicity, attendance pattern, and income level. Percentages and average amounts additionally are          described by dependency status for undergraduate students and by graduate program for graduate students. Supplemental tables feature state-level percentages of students receiving aid and average amounts received by undergraduate students. The report is available at https://nces.ed.gov/pubs2023/2023466.pdf. 

Proposed Regulations On Distance Education And State Authorization

The American Council on Education on July 18, 2023 in collaboration with the Presidents Forum hosted a discussion on Capitol Hill to examine the Department of Education’s (ED) draft regulations regarding   distance education and state authorization. Panelists explored how ED’s proposed rules to upend the      current state reciprocity agreement would create challenges for institutions offering distance education courses and their students, while also discussing a better way forward. As part of a more than 1,000 page draft rule released in May 2023, ED proposed undoing the state reciprocity agreement by requiring institutions to meet all state consumer protection laws related to recruitment, closure, and misrepresentation where distance education is offered, regardless of National Council for State Authorization Reciprocity Agreements (NC-SARA) participation. Forty-nine states participate in NC-SARA, a voluntary agreement that provides national standards for interstate postsecondary distance education. The Association of Schools of Advancing Health Professions (ASAHP) joined with other organizations in sending a letter to the ED Secretary on June 20, 2023 warning that some of the department’s proposals would be problematic. 

THE ROLE OF SOCIAL DETERMINANTS OF HEALTH

As discussed in the July 4, 2023 issue of the Journal of the American Heart Association, cardiovascular disease (CVD) is the leading cause of mortality worldwide. Addressing social determinants of health (SDoH) may be the next forefront of reducing the enormous burden of CVD. SDoH can be defined as any social, economic, or environmental factor that influences a health outcome. An umbrella review sought to give a comprehensive overview of the role of SDoH in CVD. Four themes (economic circumstances, social/community context, early childhood development, and neighborhood/built environment) and health literacy in the health/health care theme were considered. Despite the quality of the included reviews being low or critically low, there was consistent evidence that factors relating to economic circumstances and early childhood development themes were associated with an increased risk of CVD and CVD mortality. Factors in the social/community context and neighborhood/built environment themes, such as social isolation, fewer social roles, loneliness, discrimination, ethnicity, neighborhood socioeconomic status, violence, and environmental attributes had a role in CVD.  

Apart from clinical interventions, there is a need to strengthen nonmedical interventions that address multiple factors simultaneously. A possible way of doing so is addressed in the June 2023 issue of the journal The Milbank Quarterly is to expand the cadre of effective SDoH mitigation strategies. A practical, heuristic framework for policy makers, practitioners, and researchers is needed that serves as a roadmap for conceptualizing and targeting the key mechanisms of SDoH influence. A synthesis of the extant SDoH research into a heuristic framework addresses a scarcity of peer-reviewed organizing frameworks of SDoH mechanisms designed to inform practice. Development of such a framework represents a practical tool to facilitate the translation of scholarly SDoH work into evidence-based and targeted policy and programming. Tools designed to close the research-to-practice translation gap for effective SDoH mitigation are sorely needed.  

DEVELOPMENTS IN HIGHER EDUCATION

As noted in another article in this issue of TRENDS, a moratorium on student-loan payments was approved by Congress in the early days of the COVID-19 pandemic in 2020. The purpose was to suspend payments, interest charges, and collections on more than $1 trillion in debt. Originally intended to expire after a six-month period, it has been extended eight times. As a result, the federal government has lost an average of $5 billion in revenue each month since the pause began. The debt-ceiling agreement that recently became law would resume student-loan payments next August 30th. 

The June 3 issue of The Economist indicates that by the end of 2022, beneficiaries of the repayment pause accumulated an additional $2,500 in student-loan debt plus an additional $2,000 in credit-card, mortgage, and car-loan debt, boosting total household indebtedness by 8%. Jefferies, an investment bank, reckons that the return of student-loan payments, which are around $200 a month for the typical borrower, will weigh on consumer spending and push up delinquency rates. For those borrowers who took advantage of the student-debt moratorium, and accumulated additional debt over the past three years, the financial pressure could be especially acute. Meanwhile, the fate of President Biden’s proposed student debt relief program is under review by the U.S. Supreme Court. A ruling is expected to be announced this month. His proposal would cancel as much as $10,000 in federal student debt for borrowers making under $125,000 a year, or $250,000 for a married couple. Recipients of Pell Grants would be entitled to an extra $10,000 of debt cancellation.

Title IX Rulemaking Update

Changing the Department of Education’s regulations that implement Title IX of the Education Amendments of 1972 is a top priority to ensure full protection against sex discrimination for all students in federally funded education programs and activities. Title IX proposed regulations that the Department released in July 2022 would strengthen protections for students who experience sexual harassment and assault at school, and they would help protect LGBTQI+ students from discrimination. The Department received more than 240,000 public comments on the proposed rule, which is nearly twice as many as the Department received during its last rulemaking on Title IX. 

A careful review of comments takes time and is essential to ensuring that final rules are enduring. The Department is updating its Spring Unified Agenda to reflect an anticipated date of October 2023 for the final Title IX rule. Also, the Department is updating the Spring Unified Agenda to reflect an anticipated date of October 2023 for its proposed athletics regulation, which received over 150,000 comments during its recent public comment period from April 12 to May 15, 2023.  

Proposed Regulations On Gainful Employment

The May 19, 2023 issue of the Federal Register announces a proposed regulation involving gainful employment. Comments are invited on or before June 20, 2023. The financial assistance students receive under the Title IV, Higher Education Act programs for postsecondary education and training represents a significant annual expenditure by the federal government. When used effectively, this aid is a powerful tool for promoting social and economic mobility. Many programs fail to enhance students’ skills or increase their earnings effectively, however, leaving them no better off than if they had never pursued a postsecondary credential and with debt they cannot afford.  

The Department of Education is aware of a significant number of instances where institutions shut down with no warning. A recent study shows that, of closures that took place over a 16-year period, 70% of the students at such institutions (100,000 individuals) received insufficient warning that the closures were coming, which often represents a significant cost to taxpayers. Students who were enrolled at or close to the time of closure and did not graduate from the shuttered institution may receive a discharge of their federal student loans. The cost of such discharges rarely is fully reimbursed because once the institution closes, there often are few assets to use for repaying federal liabilities. Unfortunately, the Department has lacked authority under existing regulations to take action based on those indicators of risk in order to secure financial protection before the institution runs out of money and closes.

HEALTH REFORM DEVELOPMENTS

According to some encouraging news on May 24, 2023 from the Congressional Budget Office (CBO), enrollment in both Medicaid and marketplace plans have reached historic highs in 2023, mostly because of temporary policies (developed during the pandemic) that kept beneficiaries enrolled in Medicaid and that enhanced the subsidies for health insurance purchased through marketplaces. The share of the population under age 65 that is uninsured is at an unprecedented low of 8.3%. Medicaid enrollment grew from 60.5 million in 2019 to 76.6 million in 2022. In 2023, Medicaid covers 28.1% of the under-65 population and subsidized marketplace plans cover 5.2%. Employment-based insurance covers more than half (57.3%) of that population.  Low-income individuals have seen the largest gains in coverage and the largest declines in the share who lack insurance.  

Offsetting the positive news is that during the next year and a half, CBO expects substantial declines in enrollment in Medicaid as the continuous eligibility provisions implemented during the pandemic unwind. CBO projects that 6.2 million of the beneficiaries leaving Medicaid will become uninsured. Also, if the enhanced subsidies expire after 2025, as scheduled, 4.9 million fewer individuals are estimated to enroll in marketplace coverage, instead enrolling in unsubsidized nongroup or employment-based coverage or becoming uninsured. By 2033, the share of the population who is uninsured is projected to be 10.1%.  

Non-Compete Agreements, Job Mobility, And Wages

Noncompete agreements (NCAs) can restrict workers from seeking employment with a competitor or from starting a competing business. While helping companies protect confidential information, they also have the potential to lead to less job mobility and lower wages for workers. Employers historically have used these agreements for highly skilled workers and executives with access to trade secrets or other proprietary information. As discussed in a report made available on May 11, 2023 from the Government Accountability Office (GAO), a congressional watchdog agency, employers who were surveyed had all types of workers sign them, from executives to hourly employees, even though many lower wage workers may not have access to confidential information. Meanwhile, identical bills introduced in the Senate (S. 220) and the House (H.R. 731), the Workforce Mobility Act of 2023, would prohibit the use of such agreements except under certain circumstances.  

Two occupation-specific studies that examined health care workers found that substantial proportions of certain personnel are subject to NCAs. Primary care physicians in group practices are an example of individuals who had an NCA. Many workers do not have access to employers’ more sensitive information, which often makes this reason for having NCAs irrelevant. Lower-wage workers are unlikely to have access to trade secrets and some health care workers subject to NCAs, such as nurses and nursing assistants, would not have access to proprietary information that would give another hospital a competitive advantage. Also, 78% percent of responding employers with NCAs in the health care and social assistance industry (25 of 32) reported having NCAs to prevent recruitment of their staff, investors, or other resources, compared to smaller proportions of the other most common industries among the responding employers, e.g., 54% of manufacturers (26 of 48).  

Sharing Health Information

Epic, a health care software company based in Verona, Wisconsin, favors the goal of exchanging data across the entire health ecosystem. Now that some hospital systems are making a commitment to join the nationwide framework known as the Trusted Exchange Framework and Common Agreement (TEFCA) to share patient health data electronically, Epic announced in late May 2023 its first group of hospitals to take the step. More than 30 hospital systems have indicated they will join, including Kaiser Permanente, Johns Hopkins Medicine, and the Mayo Clinic. TEFCA is a public-private partnership that sets expectations and guidelines for sharing health information. More than half of hospitals are aware of TEFCA and plan to participate. Better sharing of patient records has the prospect of improving health care and avoiding clinical errors. Another item in this June 2023 issue of the newsletter TRENDS is about structural ableism. Electronic health records play an important role in the lives of individuals with a disability. One reason is that it becomes possible to identify patients who require necessary accommodations. Secondly, the electronic health record makes it possible to track the quality of care being provided. 

FEDERAL DEBT CEILING ELATION AND SORROW

A major focal point during recent weeks in the nation’s capital has been to avoid an impending crisis expected to occur unless constructive action is taken to prevent the federal debt ceiling limit from being reached in early June. The current borrowing limit is $31.4 trillion. President Biden and his Democrat colleagues in Congress for several months advocated that a clean bill should be developed, which entails no restrictions on current federal government expenditures. That view clashed with the perspective of Republicans in both legislative chambers who share a core belief that it is necessary to rein in spending that regularly contributes to unsustainable growth in the overall federal deficit. Achieving a final result following rounds of strenuous negotiations is perceived as producing either elation or sorrow, depending on where each policymaker stands along the political divide of liberal v. conservative.   

Passage of the Fiscal Responsibility Act of 2023 (H.R. 3746) made it possible to suspend the debt ceiling until the first quarter of 2025. The bill was passed in the House of Representatives on a vote of 314-117, which included 165 Democrats. The Senate gave its approval the following day on a vote of 63-36. President Biden signed the legislation into law (P.L. 118-5) on June 3. Otherwise, only two days later, the government would have been compelled to reneg on its debt obligations in the absence of a borrowing cap extension. Some features of the bill are as follows: 

The Congressional Budget Office (CBO) estimates that the deficit could be reduced by $1.5 trillion through fiscal year (FY) 2033, including a $1.3 trillion reduction in discretionary spending that starts in FY 2024.  

A 1% sequester on discretionary spending will be triggered if Congress fails to pass all FY 2024 appropriations bills. That fiscal year begins on October 1, 2023. 

Military spending would increase about 3% in FY 2024.  

Other provisions will reduce some funding for the Internal Revenue Service, tighten some work requirements for the Supplemental Nutrition Assistance Program (SNAP), and attempt to speed permitting for energy projects.   

Student-loan payments have been suspended since 2020 because of the COVID-19 pandemic. Interest accrual and repayments would restart by the end of August 2023.  

Major programs, such as Medicare and Social Security are left untouched by spending cuts in P.L. 118-5.

SEMIOTIC AND LINGUISTIC INFLUENCE

Semiotics has a focus on the study of signs and symbols. Failure to interpret them correctly in interactions between patients and clinicians may lead to unfortunate consequences that compromise health care quality. For example, touching a patient may be considered a sign of caring whereas a failure to touch may be perceived by a patient as a radically different kind of unwelcome symbol.  

The study of linguistics indicates that a single word may have several referents. According to the June 2023 issue of the Journal of Applied Gerontology, the term ageism initially was coined in 1969. Since then, it has gone through numerous transformations, reflecting different nuances. Similarly, other “ism” words are used currently to characterize the interaction between patients and clinicians, such as racism, sexism, and ableism. It also is possible to be affected by more than one ism. Ironically, someone who is both an ageist and an ableist eventually will enter old age cohorts and be affected by one or more disabilities. 

Until recent years, it was common to refer to an individual as being disabled or handicapped. The emphasis presently is on the employment of person-centered language (PCL) in health care. For example, it is preferable to refer to a patient with cancer instead of using the expression a cancer patient. The June 2023 issue of the journal Obesity discusses a study in which of the 991 articles examined, only 24.02% of publications adhered to PCL. Non-PCL in reference to obesity is widely evident, however, in weight-focused periodicals despite recommendations for adherence to PCL guidelines. It is believed that continued use of non-PCL in reference to obesity in research inadvertently may perpetuate weight-based stigma and health disparities in future generations. 

Racism also may occur alone or with ableism. The June 2023 issue of the American Journal of Psychiatry refers to an investigation in which Black and Hispanic veterans were more likely than White veterans to have an alcohol use disorder (AUD) diagnosis despite similar levels of alcohol consumption. Ableism would be applicable had they been classified as alcoholics rather than as individuals with an AUD. The difference was greatest between Black and White men. At all but the lowest and highest levels of alcohol consumption, Black men had 23%–109% greater odds of an AUD diagnosis. The findings were unchanged after adjustment for alcohol usage, alcohol-related disorders, and other potential confounders.  

Moreover, schools in the health professions may constitute a highly competitive environment where the most accomplished students are able to obtain the most prestigious and best selective post-graduation placements for internships, residency positions, and employment. Students with a disability may be reluctant to disclose that they have a particular condition, especially one that is invisible such as social anxiety disorder, fearing that doing so may hurt their future prospects, an outcome of structural ableism. The same holds true in workplace settings where seeking any special accommodation, such as needing more time to complete assignments, has the potential of triggering stigmatization by co-workers and employers.

EXPERIMENTAL CRISPR THERAPY TREATMENT

More than 50 experimental studies are underway that use gene editing in human volunteers to treat everything from cancer to HIV and blood diseases. Most of these investigations, about 40 of them, involve CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats), the most versatile of the gene-editing methods, which was developed only 10 years ago. CRISPR is a revelation to scientists because of how it can snip the genome at specific locations. A cutting protein is paired with a short gene sequence that acts like GPS, zipping to a predetermined spot in an individual's chromosomes. According to an article in the May/June 2023 issue of the journal MIT Technology Review, one of the first patients treated using a CRISPR procedure, in 2019, was Victoria Gray. At the Third International Summit on Human Genome Editing, held in London in March 2023, she described to the audience how her earlier battle with sickle-cell disease resulted in episodes that left her hospitalized for months at a time.  

Then she underwent a treatment that involved editing the genes in cells from her bone marrow. Within minutes of receiving a transfusion of edited cells, she shed tears of joy. The company developing her treatment, Vertex Pharmaceuticals, has treated more than 75 patients in its studies of sickle-cell and a related disease, beta thalassemia. The therapy could be approved for sale in the U.S. within a year. It is widely expected to be the first treatment using CRISPR to go on sale, but a price has not been announced. Other biotech companies, such as Intellia, Beam Therapeutics, and Editas Medicine, are hoping they can use this technology to develop successful treatments. Many are running trials. A challenge facing all these efforts remains placing CRISPR where it needs to go in the body, which is not easy to accomplish. In Gray's case, doctors removed bone marrow cells and edited them in the laboratory. Before they were added back to her body, however, she underwent punishing chemotherapy to kill off her remaining bone marrow in order to make room for the new cells. Meanwhile, thousands of other inherited diseases that could be treated with CRISPR are being ignored because most of them are too rare to be a viable commercial opportunity.