Ariel Dora Stern

Evaluating the Impact of the Baby-Friendly Hospital Initiative on Breast-feeding Rates: A Multi-state Analysis

OBJECTIVE To evaluate the impact of the Baby-Friendly Hospital Initiative (BFHI) on breast-feeding initiation and duration overall and according to maternal education. DESIGN Quasi-experimental study using data from five states (Alaska, Maine, Nebraska, Ohio, Washington) that participated in the Pregnancy Risk Assessment Monitoring System from 1999 to 2009. Using differences-in-differences models that included year and hospital fixed effects, we compared rates of breast-feeding initiation and duration (any and exclusive breast-feeding for ≥4 weeks) before and after BFHI accreditation between mothers who gave birth in hospitals that were accredited or became accredited and mothers from matched non-BFHI facilities. We stratified analyses into lower and higher education groups. SETTING Thirteen BFHI hospitals and nineteen matched non-BFHI facilities across five states in the USA. SUBJECTS Mothers (n 11 723) who gave birth in BFHI hospitals and mothers (n 13 604) from nineteen matched non-BFHI facilities. RESULTS Although we did not find overall differences in breast-feeding initiation between birth facilities that received BFHI accreditation compared with non-Baby-Friendly facilities (adjusted coefficient = 0·024; 95 % CI -0·00, 0·51), breast-feeding initiation increased by 3·8 percentage points among mothers with lower education who delivered in Baby-Friendly facilities (P = 0·05), but not among mothers with higher education (adjusted coefficient = 0·002; 95 % CI -0·04, 0·05). BFHI accreditation also increased exclusive breast-feeding for ≥4 weeks by 4·5 percentage points (P = 0·02) among mothers with lower education who delivered in BFHI facilities. CONCLUSIONS By increasing breast-feeding initiation and duration among mothers with lower education, the BFHI may reduce socio-economic disparities in breast-feeding.

Compliance with the Baby-Friendly Hospital Initiative and impact on breastfeeding rates

Objectives To examine compliance with the Baby-Friendly Hospital Initiative (BFHI) as well as evaluate the BFHI and its components on breastfeeding initiation and duration overall and according to maternal education level. Design Quasi-experimental study using data from the Pregnancy Risk Assessment Monitoring System (PRAMS) from 2004 to 2008. Setting Birth facilities in Maine. Participants 915 mothers who gave birth in four hospitals that were BFHI-accredited or became accredited and 1099 mothers from six matched non-BFHI facilities. Mothers reported on seven (of 10) BFHI practices (breastfeeding practice score 0–7) and receipt of a gift pack with formula (yes/no). Main outcome measures Self-report of breastfeeding initiation, any breast feeding for ≥4 weeks, exclusive breast feeding for ≥4 weeks. Results 34.6% of mothers from BFHI-accredited facilities reported experiencing all seven BFHI breastfeeding practices, while 28.4% reported being given a gift pack with formula. Among mothers with lower education, the BFHI increased breastfeeding initiation by 8.6 percentage points (adjusted coefficient, 0.086 [95% CI, 0.01 to 0.16]) and, independently, each additional breastfeeding practice was associated with an average increase in breastfeeding initiation of 16.2 percentage points (adjusted coefficient, 0.162 [95% CI, 0.15 to 0.18]). Among all mothers and mothers with higher education, there was no effect of the BFHI on breastfeeding rates. Conclusions Compliance with BFHI practices among BFHI-accredited facilities is not optimal and needs to be monitored, as greater compliance may have an even larger impact on breastfeeding rates and potentially reduce socio-economic disparities in breast feeding.

Did the Rust Belt Become Shiny? A Study of Cities and Counties That Lost Steel and Auto Jobs in the 1980s

HOW DO COUNTIES, CITIES, or regions respond to adverse economic shocks? How quickly does an area recover and through which adjustment mechanisms? These questions touch on many different areas of social science and economics and are relevant to our understanding of economic growth, income gaps across regions (for example, North and South in the United States or Italy), and the plight of individual laid-off workers and their families. In this paper we undertake a study of one of the biggest negative shocks to affect the U.S. economy in the past fifty years, namely, the massive loss of steeland auto-related jobs in the early 1980s, which we refer to collectively as the Rust Belt shock. In the decade between 1977 and 1987 the United States shed about 500,000 jobs in the auto industry and 350,000 jobs in the steel industry, far outstripping any other job losses in recent U.S. history. These job losses were concentrated in roughly 140 of the 3,000 counties in the United States. Kahn as well as Black, McKinnish, and Sanders discuss the size of the manufacturing shocks and accompanying job losses. For the first section of our paper, we assemble total employment, industrylevel employment, population, labor force participation, and income data at the level of the county and the metropolitan statistical area (MSA). Our basic approach is to regress shortand long-run changes in outcomes on the size of

Do state breastfeeding laws in the USA promote breast feeding

Objectives Despite the passage of state laws promoting breast feeding, a formal evaluation has not yet been conducted to test whether and/or what type of laws may increase breast feeding. The enactment of breastfeeding laws in different states in the USA creates a natural experiment. We examined the impact of state breastfeeding laws on breastfeeding initiation and duration as well as on disparities in these infant feeding practices. Methods Using data from the Pregnancy Risk Assessment Monitoring System, we conducted differences-in-differences models to examine breastfeeding status before and after the institution of laws between 2000 and 2008 among 326 263 mothers from 32 states in the USA. For each mother, we coded the presence of two types of state breastfeeding laws. Mothers reported whether they ever breast fed or pumped breast milk (breastfeeding initiation) and, if so, how long they continued. We defined breastfeeding duration as continuing to breast feed for ≥4 weeks. Results Breastfeeding initiation was 1.7 percentage points higher in states with new laws to provide break time and private space for breastfeeding employees (p=0.01), particularly among Hispanic mothers (adjusted coefficient 0.058). While there was no overall effect of laws permitting mothers to breast feed in any location, among Black mothers we observed increases in breastfeeding initiation (adjusted coefficient 0.056). Effects on breastfeeding duration were in the same direction, but slightly weaker. Conclusions State laws that support breast feeding appear to increase breastfeeding rates. Most of these gains were observed among Hispanic and Black women and women of lower educational attainment suggesting that such state laws may help reduce disparities in breast feeding.

How Economics Can Shape Precision Medicines

Innovation incentives, pricing, and access are critical Many public and private efforts in coming years will focus on research in precision medicine, developing biomarkers to indicate which patients are likely to benefit from a certain treatment so that others can be spared the cost—financial and physical—of being treated with unproductive therapies and therapeutic signals can be more easily uncovered. However, such research initiatives alone will not deliver new medicines to patients in the absence of strong incentives to bring new products to market. We examine the unique economics of precision medicines and associated biomarkers, with an emphasis on the factors affecting their development, pricing, and access.

The Impact of the Entry of Biosimilars: Evidence from Europe

Biologics represent a substantial and growing share of the U.S. drug market. Traditional “small molecule�? generics quickly erode the price and share of the branded product upon entry, however only a few biosimilars have been approved in the US since 2015, thereby largely preserving biologics from competition. We analyze European markets, which have had biosimilar competition since 2006. Using our own survey, we analyze how market features and public policies predict biosimilar entry, price, and penetration, finding significant heterogeneity across countries and products. Effective buyer institutions are associated with increased biosimilar penetration. Our estimates can inform ongoing policy discussions.

Innovation Incentives and Biomarkers

Previously, we have discussed the importance of economic incentives in shaping markets for precision medicines. Here we consider incentives for biomarker development, including discovery and establishment. Biomarkers can reveal valuable information regarding diagnosis and prognosis, predict treatment efficacy or toxicity, serve as markers of disease progression, and serve as auxiliary endpoints for clinical trials. Some have multiple uses, while others have a specialized role, resulting in diverse incentives across players in the healthcare system.

The Central and Unacknowledged Role of the US Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials

Overview The introduction of new medical devices has transformed cardiovascular care in recent decades. Devices, such as heart valves, pacemakers, stents, ventricular assist devices, and implantable defibrillators, have prolonged and improved the quality of life for millions of patients worldwide. Medical device innovation requires a robust ecosystem that involves medical technology innovators, often at start-ups, large medical device manufacturers, and clinical investigators. Central to this process is strong regulatory oversight, which in the United States is provided by the US Food and Drug Administration’s Center for Devices and Radiologic Health (FDA/ CDRH). This Viewpoint discusses the effect of the regulatory approval process and the role that FDA/CDRH plays in the design and execution of the pivotal trials (clinical studies) that are used to support the regulatory approval of high-risk devices. We also review norms in the publication of pivotal trials in peer-reviewed medical journals; these publications often fail to acknowledge the role of the FDA/CRH or discuss results within the context of the device approval process.