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Background: While the high prevalence of preterm births and its impact on infant mortality in the US have been widely acknowledged, recent data suggest that even full-term births in the US face substantially higher mortality risks compared to European countries with low infant mortality rates. In this paper, we use the most recent birth records in the US to more closely analyze the primary causes underlying mortality rates among full-term births.Methods and Findings: Linked birth and death records for the period 2010-2012 were used to identify the state- and cause-specific burden of infant mortality among full-term infants (born at 37-42 weeks of gestation). Multivariable logistic models were used to assess the extent to which state-level differences in full-term infant mortality (FTIM) were attributable to observed differences in maternal and birth characteristics. Random effects models were used to assess the relative contribution of state-level variation to FTIM. Hypothetical mortality outcomes were computed under the assumption that all states could achieve the survival rates of the best-performing states. A total of 10,175,481 infants born full-term in the US between January 1, 2010, and December 31, 2012, were analyzed. FTIM rate (FTIMR) was 2.2 per 1,000 live births overall, and ranged between 1.29 (Connecticut, 95% CI 1.08, 1.53) and 3.77 (Mississippi, 95% CI 3.39, 4.19) at the state level. Zero states reached the rates reported in the 6 low-mortality European countries analyzed (FTIMR < 1.25), and 13 states had FTIMR > 2.75. Sudden unexpected death in infancy (SUDI) accounted for 43% of FTIM; congenital malformations and perinatal conditions accounted for 31% and 11.3% of FTIM, respectively. The largest mortality differentials between states with good and states with poor FTIMR were found for SUDI, with particularly large risk differentials for deaths due to sudden infant death syndrome (SIDS) (odds ratio [OR] 2.52, 95% CI 1.86, 3.42) and suffocation (OR 4.40, 95% CI 3.71, 5.21). Even though these mortality differences were partially explained by state-level differences in maternal education, race, and maternal health, substantial state-level variation in infant mortality remained in fully adjusted models (SIDS OR 1.45, suffocation OR 2.92). The extent to which these state differentials are due to differential antenatal care standards as well as differential access to health services could not be determined due to data limitations. Overall, our estimates suggest that infant mortality could be reduced by 4,003 deaths (95% CI 2,284, 5,587) annually if all states were to achieve the mortality levels of the best-performing state in each cause-of-death category. Key limitations of the analysis are that information on termination rates at the state level was not available, and that causes of deaths may have been coded differentially across states.Conclusions: More than 7,000 full-term infants die in the US each year. The results presented in this paper suggest that a substantial share of these deaths may be preventable. Potential improvements seem particularly large for SUDI, where very low rates have been achieved in a few states while average mortality rates remain high in most other areas. Given the high mortality burden due to SIDS and suffocation, policy efforts to promote compliance with recommended sleeping arrangements could be an effective first step in this direction. [ABSTRACT FROM AUTHOR]

Background: Reductions in smoking in Arizona and California have been shown to be associated with reduced per capita healthcare expenditures in these states compared to control populations in the rest of the US. This paper extends that analysis to all states and estimates changes in healthcare expenditure attributable to changes in aggregate measures of smoking behavior in all states.Methods and Findings: State per capita healthcare expenditure is modeled as a function of current smoking prevalence, mean cigarette consumption per smoker, other demographic and economic factors, and cross-sectional time trends using a fixed effects panel data regression on annual time series data for each the 50 states and the District of Columbia for the years 1992 through 2009. We found that 1% relative reductions in current smoking prevalence and mean packs smoked per current smoker are associated with 0.118% (standard error [SE] 0.0259%, p < 0.001) and 0.108% (SE 0.0253%, p < 0.001) reductions in per capita healthcare expenditure (elasticities). The results of this study are subject to the limitations of analysis of aggregate observational data, particularly that a study of this nature that uses aggregate data and a relatively small sample size cannot, by itself, establish a causal connection between smoking behavior and healthcare costs. Historical regional variations in smoking behavior (including those due to the effects of state tobacco control programs, smoking restrictions, and differences in taxation) are associated with substantial differences in per capita healthcare expenditures across the United States. Those regions (and the states in them) that have lower smoking have substantially lower medical costs. Likewise, those that have higher smoking have higher medical costs. Sensitivity analysis confirmed that these results are robust.Conclusions: Changes in healthcare expenditure appear quickly after changes in smoking behavior. A 10% relative drop in smoking in every state is predicted to be followed by an expected $63 billion reduction (in 2012 US dollars) in healthcare expenditure the next year. State and national policies that reduce smoking should be part of short term healthcare cost containment. [ABSTRACT FROM AUTHOR]

Background: Exposure to fine particulate matter pollution (PM2.5) is hazardous to health. Our aim was to directly estimate the health and longevity impacts of current PM2.5 concentrations and the benefits of reductions from 1999 to 2015, nationally and at county level, for the entire contemporary population of the contiguous United States.Methods and Findings: We used vital registration and population data with information on sex, age, cause of death, and county of residence. We used four Bayesian spatiotemporal models, with different adjustments for other determinants of mortality, to directly estimate mortality and life expectancy loss due to current PM2.5 pollution and the benefits of reductions since 1999, nationally and by county. The covariates included in the adjusted models were per capita income; percentage of population whose family income is below the poverty threshold, who are of Black or African American race, who have graduated from high school, who live in urban areas, and who are unemployed; cumulative smoking; and mean temperature and relative humidity. In the main model, which adjusted for these covariates and for unobserved county characteristics through the use of county-specific random intercepts, PM2.5 pollution in excess of the lowest observed concentration (2.8 μg/m3) was responsible for an estimated 15,612 deaths (95% credible interval 13,248-17,945) in females and 14,757 deaths (12,617-16,919) in males. These deaths would lower national life expectancy by an estimated 0.15 years (0.13-0.17) for women and 0.13 years (0.11-0.15) for men. The life expectancy loss due to PM2.5 was largest around Los Angeles and in some southern states such as Arkansas, Oklahoma, and Alabama. At any PM2.5 concentration, life expectancy loss was, on average, larger in counties with lower income and higher poverty rate than in wealthier counties. Reductions in PM2.5 since 1999 have lowered mortality in all but 14 counties where PM2.5 increased slightly. The main limitation of our study, similar to other observational studies, is that it is not guaranteed for the observed associations to be causal. We did not have annual county-level data on other important determinants of mortality, such as healthcare access and quality and diet, but these factors were adjusted for with use of county-specific random intercepts.Conclusions: According to our estimates, recent reductions in particulate matter pollution in the USA have resulted in public health benefits. Nonetheless, we estimate that current concentrations are associated with mortality impacts and loss of life expectancy, with larger impacts in counties with lower income and higher poverty rate. [ABSTRACT FROM AUTHOR]

Background: There is ongoing debate about whether education or socioeconomic status (SES) should be inputs into cardiovascular disease (CVD) prediction algorithms and clinical risk adjustment models. It is also unclear whether intervening on education will affect CVD, in part because there is controversy regarding whether education is a determinant of CVD or merely correlated due to confounding or reverse causation. We took advantage of a natural experiment to estimate the population-level effects of educational attainment on CVD and related risk factors.Methods and Findings: We took advantage of variation in United States state-level compulsory schooling laws (CSLs), a natural experiment that was associated with geographic and temporal differences in the minimum number of years that children were required to attend school. We linked census data on educational attainment (N = approximately 5.4 million) during childhood with outcomes in adulthood, using cohort data from the 1992-2012 waves of the Health and Retirement Study (HRS; N = 30,853) and serial cross-sectional data from 1971-2012 waves of the National Health and Nutrition Examination Survey (NHANES; N = 44,732). We examined self-reported CVD outcomes and related risk factors, as well as relevant serum biomarkers. Using instrumental variables (IV) analysis, we found that increased educational attainment was associated with reduced smoking (HRS β -0.036, 95%CI: -0.06, -0.02, p < 0.01; NHANES β -0.032, 95%CI: -0.05, -0.02, p < 0.01), depression (HRS β -0.049, 95%CI: -0.07, -0.03, p < 0.01), triglycerides (NHANES β -0.039, 95%CI: -0.06, -0.01, p < 0.01), and heart disease (HRS β -0.025, 95%CI: -0.04, -0.002, p = 0.01), and improvements in high-density lipoprotein (HDL) cholesterol (HRS β 1.50, 95%CI: 0.34, 2.49, p < 0.01; NHANES β 0.86, 95%CI: 0.32, 1.48, p < 0.01), but increased BMI (HRS β 0.20, 95%CI: 0.002, 0.40, p = 0.05; NHANES β 0.13, 95%CI: 0.01, 0.32, p = 0.05) and total cholesterol (HRS β 2.73, 95%CI: 0.09, 4.97, p = 0.03). While most findings were cross-validated across both data sets, they were not robust to the inclusion of state fixed effects. Limitations included residual confounding, use of self-reported outcomes for some analyses, and possibly limited generalizability to more recent cohorts.Conclusions: This study provides rigorous population-level estimates of the association of educational attainment with CVD. These findings may guide future implementation of interventions to address the social determinants of CVD and strengthen the argument for including educational attainment in prediction algorithms and primary prevention guidelines for CVD. [ABSTRACT FROM AUTHOR]

Background: College affirmative action programs seek to expand socioeconomic opportunities for underrepresented minorities. Between 1996 and 2013, 9 US states-including California, Texas, and Michigan-banned race-based affirmative action in college admissions. Because economic opportunity is known to motivate health behavior, banning affirmative action policies may have important adverse spillover effects on health risk behaviors. We used a quasi-experimental research design to evaluate the association between college affirmative action bans and health risk behaviors among underrepresented minority (Black, Hispanic, and Native American) adolescents.Methods and Findings: We conducted a difference-in-differences analysis using data from the 1991-2015 US national Youth Risk Behavior Survey (YRBS). We compared changes in self-reported cigarette smoking and alcohol use in the 30 days prior to survey among underrepresented minority 11th and 12th graders in states implementing college affirmative action bans (Arizona, California, Florida, Michigan, Nebraska, New Hampshire, Oklahoma, Texas, and Washington) versus outcomes among those residing in states not implementing bans (n = 35 control states). We also assessed whether underrepresented minority adults surveyed in the 1992-2015 Tobacco Use Supplement to the Current Population Survey (TUS-CPS) who were exposed to affirmative action bans during their late high school years continued to smoke cigarettes between the ages of 19 and 30 years. Models adjusted for individual demographic characteristics, state and year fixed effects, and state-specific secular trends. In the YRBS (n = 34,988 to 36,268, depending on the outcome), cigarette smoking in the past 30 days among underrepresented minority 11th-12th graders increased by 3.8 percentage points after exposure to an affirmative action ban (95% CI: 2.0, 5.7; p < 0.001). In addition, there were also apparent increases in past-30-day alcohol use, by 5.9 percentage points (95% CI: 0.3, 12.2; p = 0.041), and past-30-day binge drinking, by 3.5 percentage points (95% CI: -0.1, 7.2, p = 0.058), among underrepresented minority 11th-12th graders, though in both cases adjustment for multiple comparisons resulted in failure to reject the null hypothesis (adjusted p = 0.083 for both outcomes). Underrepresented minority adults in the TUS-CPS (n = 71,575) exposed to bans during their late high school years were also 1.8 percentage points more likely to report current smoking (95% CI: 0.1, 3.6; p = 0.037). Event study analyses revealed a discrete break for all health behaviors timed with policy discussion and implementation. No substantive or statistically significant effects were found for non-Hispanic White adolescents, and the findings were robust to a number of additional specification checks. The limitations of the study include the continued potential for residual confounding from unmeasured time-varying factors and the potential for recall bias due to the self-reported nature of the health risk behavior outcomes.Conclusions: In this study, we found evidence that some health risk behaviors increased among underrepresented minority adolescents after exposure to state-level college affirmative action bans. These findings suggest that social policies that shift socioeconomic opportunities could have meaningful population health consequences. [ABSTRACT FROM AUTHOR]

Background: Treatment decision-making regarding immunosuppressive therapy is challenging for individuals with lupus. We assessed the effectiveness of a decision aid for immunosuppressive therapy in lupus nephritis.Methods and Findings: In a United States multicenter, open-label, randomized controlled trial (RCT), adult women with lupus nephritis, mostly from racial/ethnic minority backgrounds with low socioeconomic status (SES), seen in in- or outpatient settings, were randomized to an individualized, culturally tailored, computerized decision aid versus American College of Rheumatology (ACR) lupus pamphlet (1:1 ratio), using computer-generated randomization. We hypothesized that the co-primary outcomes of decisional conflict and informed choice regarding immunosuppressive medications would improve more in the decision aid group. Of 301 randomized women, 298 were analyzed; 47% were African-American, 26% Hispanic, and 15% white. Mean age (standard deviation [SD]) was 37 (12) years, 57% had annual income of <$40,000, and 36% had a high school education or less. Compared with the provision of the ACR lupus pamphlet (n = 147), participants randomized to the decision aid (n = 151) had (1) a clinically meaningful and statistically significant reduction in decisional conflict, 21.8 (standard error [SE], 2.5) versus 12.7 (SE, 2.0; p = 0.005) and (2) no difference in informed choice in the main analysis, 41% versus 31% (p = 0.08), but clinically meaningful and statistically significant difference in sensitivity analysis (net values for immunosuppressives positive [in favor] versus negative [against]), 50% versus 35% (p = 0.006). Unresolved decisional conflict was lower in the decision aid versus pamphlet groups, 22% versus 44% (p < 0.001). Significantly more patients in the decision aid versus pamphlet group rated information to be excellent for understanding lupus nephritis (49% versus 33%), risk factors (43% versus 27%), medication options (50% versus 33%; p ≤ 0.003 for all); and the ease of use of materials was higher in the decision aid versus pamphlet groups (51% versus 38%; p = 0.006). Key study limitations were the exclusion of men, short follow-up, and the lack of clinical outcomes, including medication adherence.Conclusions: An individualized decision aid was more effective than usual care in reducing decisional conflict for choice of immunosuppressive medications in women with lupus nephritis.Trial Registration: Clinicaltrials.gov, NCT02319525. [ABSTRACT FROM AUTHOR]

Background: The Supplemental Nutrition Assistance Program (SNAP) provides approximately US$70 billion annually to support food purchases by low-income households, supporting approximately 1 in 7 Americans. In the 2018 Farm Bill, potential SNAP revisions to improve diets and health could include financial incentives, disincentives, or restrictions for certain foods. However, the overall and comparative impacts on health outcomes and costs are not established. We aimed to estimate the health impact, program and healthcare costs, and cost-effectiveness of food incentives, disincentives, or restrictions in SNAP.Methods and Findings: We used a validated microsimulation model (CVD-PREDICT), populated with national data on adult SNAP participants from the National Health and Nutrition Examination Survey (NHANES) 2009-2014, policy effects from SNAP pilots and food pricing meta-analyses, diet-disease effects from meta-analyses, and policy, food, and healthcare costs from published literature to estimate the overall and comparative impacts of 3 dietary policy interventions: (1) a 30% incentive for fruits and vegetables (F&V), (2) a 30% F&V incentive with a restriction of sugar-sweetened beverages (SSBs), and (3) a broader incentive/disincentive program for multiple foods that also preserves choice (SNAP-plus), combining 30% incentives for F&V, nuts, whole grains, fish, and plant-based oils and 30% disincentives for SSBs, junk food, and processed meats. Among approximately 14.5 million adults on SNAP at baseline with mean age 52 years, our simulation estimates that the F&V incentive over 5 years would prevent 38,782 cardiovascular disease (CVD) events, gain 18,928 quality-adjusted life years (QALYs), and save $1.21 billion in healthcare costs. Adding SSB restriction increased gains to 93,933 CVD events prevented, 45,864 QALYs gained, and $4.33 billion saved. For SNAP-plus, corresponding gains were 116,875 CVD events prevented, 56,056 QALYs gained, and $5.28 billion saved. Over a lifetime, the F&V incentive would prevent approximately 303,900 CVD events, gain 649,000 QALYs, and save $6.77 billion in healthcare costs. Adding SSB restriction increased gains to approximately 797,900 CVD events prevented, 2.11 million QALYs gained, and $39.16 billion in healthcare costs saved. For SNAP-plus, corresponding gains were approximately 940,000 CVD events prevented, 2.47 million QALYs gained, and $41.93 billion saved. From a societal perspective (including programmatic costs but excluding food subsidy costs as an intra-societal transfer), all 3 scenarios were cost-saving. From a government affordability perspective (i.e., incorporating food subsidy costs, including for children and young adults for whom no health gains were modeled), the F&V incentive was of low cost-effectiveness at 5 years (incremental cost-effectiveness ratio: $548,053/QALY) but achieved cost-effectiveness ($66,525/QALY) over a lifetime. Adding SSB restriction, the intervention was cost-effective at 10 years ($68,857/QALY) and very cost-effective at 20 years ($26,435/QALY) and over a lifetime ($5,216/QALY). The combined incentive/disincentive program produced the largest health gains and reduced both healthcare and food costs, with net cost-savings of $10.16 billion at 5 years and $63.33 billion over a lifetime. Results were consistent in probabilistic sensitivity analyses: for example, from a societal perspective, 1,000 of 1,000 iterations (100%) were cost-saving for all 3 interventions. Due to the nature of simulation studies, the findings cannot prove the health and cost impacts of national SNAP interventions.Conclusions: Leveraging healthier eating through SNAP could generate substantial health benefits and be cost-effective or cost-saving. A combined food incentive/disincentive program appears most effective and may be most attractive to policy-makers. [ABSTRACT FROM AUTHOR]

Background: Medicare Advantage (MA) and Medicare fee-for-service (FFS) plans have different financial incentives. Medicare pays predetermined rates per beneficiary to MA plans for providing care throughout the year, while providers serving FFS patients are reimbursed per utilization event. It is unknown how these incentives affect post-acute care in skilled nursing facilities (SNFs). The objective of this study was to examine differences in rehabilitation service use, length of stay, and outcomes for patients following hip fracture between FFS and MA enrollees.Methods and Findings: This was a retrospective cohort study to examine differences in health service utilization and outcomes between FFS and MA patients in SNFs following hip fracture hospitalization during the period January 1, 2011, to June 30, 2015, and followed up until December 31, 2015. We linked the Master Beneficiary Summary File, Medicare Provider and Analysis Review data, Healthcare Effectiveness Data and Information Set data, the Minimum Data Set, and the American Community Survey. The 6 primary outcomes of interest in this study included 2 process measures and 4 patient-centered outcomes. Process measures included length of stay in the SNF and average rehabilitation therapy minutes (physical and occupational therapy) received per day. Patient-centered outcomes included 30-day hospital readmission, changes in functional status as measured by the 28-point late loss MDS-ADL scale, likelihood of becoming a long-term resident, and successful discharge to the community. Successful discharge from a SNF was defined as being discharged to the community within 100 days of SNF admission and remaining alive in the community without being institutionalized in any acute or post-acute setting for at least 30 days. We analyzed 211,296 FFS and 75,554 MA patients with hip fracture admitted directly to a SNF following an index hospitalization who had not been in a nursing facility or hospital in the preceding year. We used inverse probability of treatment weighting (IPTW) and nursing facility fixed effects regression models to compare treatments and outcomes between MA and FFS patients. MA patients were younger and less cognitively impaired upon SNF admission than FFS patients. After applying IPTW, demographic and clinical characteristics of MA patients were comparable with those of FFS patients. After adjusting for risk factors using IPTW-weighted fixed effects regression models, MA patients spent 5.1 (95% CI -5.4 to -4.8) fewer days in the SNF and received 463 (95% CI to -483.2 to -442.4) fewer minutes of total rehabilitation therapy during the first 40 days following SNF admission, i.e., 12.1 (95% CI -12.7 to -11.4) fewer minutes of rehabilitation therapy per day compared to FFS patients. In addition, MA patients had a 1.2 percentage point (95% CI -1.5 to -1.1) lower 30-day readmission rate, 0.6 percentage point (95% CI -0.8 to -0.3) lower rate of becoming a long-stay resident, and a 3.2 percentage point (95% CI 2.7 to 3.7) higher rate of successful discharge to the community compared to FFS patients. The major limitation of this study was that we only adjusted for observed differences to address selection bias between FFS and MA patients with hip fracture. Therefore, results may not be generalizable to other conditions requiring extensive rehabilitation.Conclusions: Compared to FFS patients, MA patients had a shorter course of rehabilitation but were more likely to be discharged to the community successfully and were less likely to experience a 30-day hospital readmission. Longer lengths of stay may not translate into better outcomes in the case of hip fracture patients in SNFs. [ABSTRACT FROM AUTHOR]

Background: Tobacco addiction is a complex, multicomponent phenomenon stemming from nicotine's pharmacology and the user's biology, psychology, sociology, and environment. After decades of public denial, the tobacco industry now agrees with public health authorities that nicotine is addictive. In 2000, Philip Morris became the first major tobacco company to admit nicotine's addictiveness. Evolving definitions of addiction have historically affected subsequent policymaking. This article examines how Philip Morris internally conceptualized addiction immediately before and after this announcement.Methods and Findings: We analyzed previously secret, internal Philip Morris documents made available as a result of litigation against the tobacco industry. We compared these documents to public company statements and found that Philip Morris's move from public denial to public affirmation of nicotine's addictiveness coincided with pressure on the industry from poor public approval ratings, the Master Settlement Agreement (MSA), the United States government's filing of the Racketeer Influenced and Corrupt Organizations (RICO) suit, and the Institute of Medicine's (IoM's) endorsement of potentially reduced risk products. Philip Morris continued to research the causes of addiction through the 2000s in order to create successful potentially reduced exposure products (PREPs). While Philip Morris's public statements reinforce the idea that nicotine's pharmacology principally drives smoking addiction, company scientists framed addiction as the result of interconnected biological, social, psychological, and environmental determinants, with nicotine as but one component. Due to the fragmentary nature of the industry document database, we may have missed relevant information that could have affected our analysis.Conclusions: Philip Morris's research suggests that tobacco industry activity influences addiction treatment outcomes. Beyond nicotine's pharmacology, the industry's continued aggressive advertising, lobbying, and litigation against effective tobacco control policies promotes various nonpharmacological determinants of addiction. To help tobacco users quit, policy makers should increase attention on the social and environmental dimensions of addiction alongside traditional cessation efforts. [ABSTRACT FROM AUTHOR]

Background: In February 2011, an Ohio law took effect mandating use of the United States Food and Drug Administration (FDA)-approved protocol for mifepristone, which is used with misoprostol for medication abortion. Other state legislatures have passed or enacted similar laws requiring use of the FDA-approved protocol for medication abortion. The objective of this study is to examine the association of this legal change with medication abortion outcomes and utilization.Methods and Findings: We used a retrospective cohort design, comparing outcomes of medication abortion patients in the prelaw period to those in the postlaw period. Sociodemographic and clinical chart data were abstracted from all medication abortion patients from 1 y prior to the law's implementation (January 2010-January 2011) to 3 y post implementation (February 2011-October 2014) at four abortion-providing health care facilities in Ohio. Outcome data were analyzed for all women undergoing abortion at ≤49 d gestation during the study period. The main outcomes were as follows: need for additional intervention following medication abortion (such as aspiration, repeat misoprostol, and blood transfusion), frequency of continuing pregnancy, reports of side effects, and the proportion of abortions that were medication abortions (versus other abortion procedures). Among the 2,783 medication abortions ≤49 d gestation, 4.9% (95% CI: 3.7%-6.2%) in the prelaw and 14.3% (95% CI: 12.6%-16.0%) in the postlaw period required one or more additional interventions. Women obtaining a medication abortion in the postlaw period had three times the odds of requiring an additional intervention as women in the prelaw period (adjusted odds ratio [AOR] = 3.11, 95% CI: 2.27-4.27). In a mixed effects multivariable model that uses facility-months as the unit of analysis to account for lack of independence by site, we found that the law change was associated with a 9.4% (95% CI: 4.0%-18.4%) absolute increase in the rate of requiring an additional intervention. The most common subsequent intervention in both periods was an additional misoprostol dose and was most commonly administered to treat incomplete abortion. The percentage of women requiring two or more follow-up visits increased from 4.2% (95% CI: 3.0%-5.3%) in the prelaw period to 6.2% (95% CI: 5.5%-8.0%) in the postlaw period (p = 0.003). Continuing pregnancy was rare (0.3%). Overall, 12.6% of women reported at least one side effect during their medication abortion: 8.4% (95% CI: 6.8%-10.0%) in the prelaw period and 15.6% (95% CI: 13.8%-17.3%) in the postlaw period (p < 0.001). Medication abortions fell from 22% (95% CI: 20.8%-22.3%) of all abortions the year before the law went into effect (2010) to 5% (95% CI: 4.8%-5.6%) 3 y after (2014) (p < 0.001). The average patient charge increased from US$426 in 2010 to US$551 in 2014, representing a 16% increase after adjusting for inflation in medical prices. The primary limitation to the study is that it was a pre/post-observational study with no control group that was not exposed to the law.Conclusions: Ohio law required use of a medication abortion protocol that is associated with a greater need for additional intervention, more visits, more side effects, and higher costs for women relative to the evidence-based protocol. There is no evidence that the change in law led to improved abortion outcomes. Indeed, our findings suggest the opposite. In March 2016, the FDA-protocol was updated, so Ohio providers may now legally provide current evidence-based protocols. However, this law is still in place and bans physicians from using mifepristone based on any new developments in clinical research as best practices continue to be updated. [ABSTRACT FROM AUTHOR]

Background: European Union law prohibits companies from marketing drugs off-label. In the United Kingdom--as in some other European countries, but unlike the United States--industry self-regulatory bodies are tasked with supervising compliance with marketing rules. The objectives of this study were to (1) characterize off-label promotion rulings in the UK compared to the whistleblower-initiated cases in the US and (2) shed light on the UK self-regulatory mechanism for detecting, deterring, and sanctioning off-label promotion.Methods and Findings: We conducted structured reviews of rulings by the UK self-regulatory authority, the Prescription Medicines Code of Practice Authority (PMCPA), between 2003 and 2012. There were 74 off-label promotion rulings involving 43 companies and 65 drugs. Nineteen companies were ruled in breach more than once, and ten companies were ruled in breach three or more times over the 10-y period. Drawing on a typology previously developed to analyse US whistleblower complaints, we coded and analysed the apparent strategic goals of each off-label marketing scheme and the practices consistent with those alleged goals. 50% of rulings cited efforts to expand drug use to unapproved indications, and 39% and 38% cited efforts to expand beyond approved disease entities and dosing strategies, respectively. The most frequently described promotional tactic was attempts to influence prescribers (n = 72, 97%), using print material (70/72, 97%), for example, advertisements (21/70, 30%). Although rulings cited prescribers as the prime target of off-label promotion, competing companies lodged the majority of complaints (prescriber: n = 16, 22%, versus companies: n = 42, 57%). Unlike US whistleblower complaints, few UK rulings described practices targeting consumers (n = 3, 4%), payers (n = 2, 3%), or company staff (n = 2, 3%). Eight UK rulings (11%) pertaining to six drugs described promotion of the same drug for the same off-label use as was alleged by whistleblowers in the US. However, while the UK cases typically related to only one or a few claims made in printed material, several complaints in the US alleged multifaceted and covert marketing activities. Because this study is limited to PMCPA rulings and whistleblower-initiated federal cases, it may offer a partial view of exposed off-label marketing.Conclusion: The UK self-regulatory system for exposing marketing violations relies largely on complaints from company outsiders, which may explain why most off-label promotion rulings relate to plainly visible promotional activities such as advertising. This contrasts with the US, where Department of Justice investigations and whistleblower testimony have alleged complex off-label marketing campaigns that remain concealed to company outsiders. UK authorities should consider introducing increased incentives and protections for whistleblowers combined with US-style governmental investigations and meaningful sanctions. UK prescribers should be attentive to, and increasingly report, off-label promotion. [ABSTRACT FROM AUTHOR]

: Daniel Weinberger and colleagues examine a possible interaction between two serious respiratory infections in children under 2 years of age. Please see later in the article for the Editors' Summary [ABSTRACT FROM AUTHOR]

: Rakesh Bhattacharjee and colleagues use data from a US private health insurance database to compare asthma severity measures in children one year before and one year after they underwent adenotonsillectomy with asthma measures in those who did not undergo adenotonsillectomy. Please see later in the article for the Editors' Summary [ABSTRACT FROM AUTHOR]