The FDA And ABCs: Unintended Consequences Of Antidepressant Warnings On Human Capital.
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ABSTRACT:
SUBMITTER: Busch SH
PROVIDER: S-EPMC4181847 | biostudies-literature | 2014
REPOSITORIES: biostudies-literature
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The FDA And ABCs: Unintended Consequences Of Antidepressant Warnings On Human Capital.
Busch Susan H SH Golberstein Ezra E Meara Ellen E
The Journal of human resources 20140101 3
Using annual cross-sectional data on over 100,000 adolescents aged 12-17, we studied academic and behavioral outcomes among those who were and were not likely affected by FDA warnings regarding the safety of antidepressants. Compared to other adolescents, adolescents with probable depression experienced a relative decline in grade point average of .14 points following the FDA warnings. The FDA warnings also coincided with increased delinquency, use of tobacco and use of illicit drugs. Together, ...[more]
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Project description:OBJECTIVE Numerous articles have identified that medical technologies diffuse more rapidly among non-Latino whites compared with other racial-ethnic groups. However, whether health risk warnings also diffuse differentially across racial-ethnic minority groups is uncertain. This study assessed racial-ethnic variation in children's antidepressant use before and after the 2004 black-box warning concerning risks of antidepressants for youths. METHODS Data consisted of responses for white, black, and Latino youths ages five through 17 from the 2002-2008 Medical Expenditure Panel Survey (N=44,422). The dependent variable was any antidepressant use in the prior year. Independent variables were race-ethnicity, year, psychological impairment, income, insurance status, region, and parents' education level. Logistic regression models were used to assess antidepressant use conditional on race-ethnicity, time, interaction between race-ethnicity and time, need, socioeconomic status, and Institute of Medicine-concordant estimates of disparities in predicted antidepressant use before and after the warning. RESULTS The warnings affected antidepressant use differentially for whites, blacks, and Latinos. Usage rates among whites decreased from 3.3 to 2.1 percentage points between prewarning and postwarning, whereas usage rates remained steady among Latinos and increased among blacks. Findings were significant in multiple regression analyses, in which predictions were adjusted for need. CONCLUSIONS The findings indicate that health safety information on antidepressant usage among children diffused faster among whites than nonwhites, suggesting the need to improve infrastructure for delivering important health messages to racial-ethnic minority populations.
| S-EPMC3686566 | biostudies-literature
Project description:The Food and Drug Administration's 2004 antidepressant warning was followed by decreases in antidepressant prescribing for youth. This was due to declines in all types of depression treatment, not just the intended changes in antidepressant prescribing patterns. Little is known about how these patterns varied by race/ethnicity.Data are Medicaid claims from four U.S. states (2002-2009) for youth ages 5-17. Interrupted time series analyses measured changes due to the warning in levels and trends, by race/ethnicity, of three outcomes: antidepressant prescription fills, depression treatment visits, and incident fluoxetine prescription fills.Prewarning, antidepressant fills were increasing across all racial/ethnic groups, fastest for White youth. Postwarning, there was an immediate drop and continued decline in the rate of fills among White youth, more than double the decline in the rate among Black and Latino youth. Prewarning, depression treatment visits were increasing for White and Latino youth. Postwarning, depression treatment stabilized among Latinos, but declined among White youth. Prewarning, incident fluoxetine fills were increasing for all groups. Postwarning, immediate increases and increasing trends of fluoxetine fills were identified for all groups.Antidepressant prescription fills declined most postwarning for White youth, suggesting that risk information may have diffused less rapidly to prescribers or caregivers of minorities. Decreases in depression treatment visits help to explain the declines in antidepressant prescribing and were largest for White youth. An increase in incident fluoxetine fills, the only medication indicated for pediatric depression at the time, suggests that the warning may have shifted prescribing practices.
| S-EPMC5895183 | biostudies-literature
Project description:ObjectiveTo investigate if the widely publicized warnings in 2003 from the US Food and Drug Administration about a possible increased risk of suicidality with antidepressant use in young people were associated with changes in antidepressant use, suicide attempts, and completed suicides among young people.DesignQuasi-experimental study assessing changes in outcomes after the warnings, controlling for pre-existing trends.SettingAutomated healthcare claims data (2000-10) derived from the virtual data warehouse of 11 health plans in the US Mental Health Research Network.ParticipantsStudy cohorts included adolescents (around 1.1 million), young adults (around 1.4 million), and adults (around 5 million).Main outcome measuresRates of antidepressant dispensings, psychotropic drug poisonings (a validated proxy for suicide attempts), and completed suicides.ResultsTrends in antidepressant use and poisonings changed abruptly after the warnings. In the second year after the warnings, relative changes in antidepressant use were -31.0% (95% confidence interval -33.0% to -29.0%) among adolescents, -24.3% (-25.4% to -23.2%) among young adults, and -14.5% (-16.0% to -12.9%) among adults. These reflected absolute reductions of 696, 1216, and 1621 dispensings per 100,000 people among adolescents, young adults, and adults, respectively. Simultaneously, there were significant, relative increases in psychotropic drug poisonings in adolescents (21.7%, 95% confidence interval 4.9% to 38.5%) and young adults (33.7%, 26.9% to 40.4%) but not among adults (5.2%, -6.5% to 16.9%). These reflected absolute increases of 2 and 4 poisonings per 100,000 people among adolescents and young adults, respectively (approximately 77 additional poisonings in our cohort of 2.5 million young people). Completed suicides did not change for any age group.ConclusionsSafety warnings about antidepressants and widespread media coverage decreased antidepressant use, and there were simultaneous increases in suicide attempts among young people. It is essential to monitor and reduce possible unintended consequences of FDA warnings and media reporting.
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Project description:In this paper we review the associations between maternal and child undernutrition with human capital and risk of adult diseases in low-income and middle-income countries. We analysed data from five long-standing prospective cohort studies from Brazil, Guatemala, India, the Philippines, and South Africa and noted that indices of maternal and child undernutrition (maternal height, birthweight, intrauterine growth restriction, and weight, height, and body-mass index at 2 years according to the new WHO growth standards) were related to adult outcomes (height, schooling, income or assets, offspring birthweight, body-mass index, glucose concentrations, blood pressure). We undertook systematic reviews of studies from low-income and middle-income countries for these outcomes and for indicators related to blood lipids, cardiovascular disease, lung and immune function, cancers, osteoporosis, and mental illness. Undernutrition was strongly associated, both in the review of published work and in new analyses, with shorter adult height, less schooling, reduced economic productivity, and--for women--lower offspring birthweight. Associations with adult disease indicators were not so clear-cut. Increased size at birth and in childhood were positively associated with adult body-mass index and to a lesser extent with blood pressure values, but not with blood glucose concentrations. In our new analyses and in published work, lower birthweight and undernutrition in childhood were risk factors for high glucose concentrations, blood pressure, and harmful lipid profiles once adult body-mass index and height were adjusted for, suggesting that rapid postnatal weight gain--especially after infancy--is linked to these conditions. The review of published works indicates that there is insufficient information about long-term changes in immune function, blood lipids, or osteoporosis indicators. Birthweight is positively associated with lung function and with the incidence of some cancers, and undernutrition could be associated with mental illness. We noted that height-for-age at 2 years was the best predictor of human capital and that undernutrition is associated with lower human capital. We conclude that damage suffered in early life leads to permanent impairment, and might also affect future generations. Its prevention will probably bring about important health, educational, and economic benefits. Chronic diseases are especially common in undernourished children who experience rapid weight gain after infancy.
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Project description:The boxed warning (also known as 'black box warning [BBW]') is one of the strongest drug safety actions that the U.S. Food & Drug Administration (FDA) can implement, and often warns of serious risks. The objective of this study was to comprehensively characterize BBWs issued for drugs after FDA approval.We identified all post-marketing BBWs from January 2008 through June 2015 listed on FDA's MedWatch and Drug Safety Communications websites. We used each drug's prescribing information to classify its BBW as new, major update to a preexisting BBW, or minor update. We then characterized these BBWs with respect to pre-specified BBW-specific and drug-specific features.There were 111 BBWs issued to drugs on the US market, of which 29% (n = 32) were new BBWs, 32% (n = 35) were major updates, and 40% (n = 44) were minor updates. New BBWs and major updates were most commonly issued for death (51%) and cardiovascular risk (27%). The new BBWs and major updates impacted 200 drug formulations over the study period, of which 64% were expected to be used chronically and 58% had available alternatives without a BBW.New BBWs and incremental updates to existing BBWs are frequently added to drug labels after regulatory approval.
| S-EPMC6013049 | biostudies-literature
Project description:Since the early 2000s, China has carried out extensive "grain-for-green" and grazing exclusion practices to combat desertification in the desertification-prone region (DPR). However, the environmental and socioeconomic impacts of these practices remain unclear. We quantify and compare the changes in fractional vegetation cover (FVC) with economic and population data in the DPR before and after the implementation of these environmental programmes. Here we show that climatic change and CO2 fertilization are relatively strong drivers of vegetation rehabilitation from 2001-2020 in the DPR, and the declines in the direct incomes of farmers and herders caused by ecological practices exceed the subsidies provided by governments. To minimize economic hardship, enhance food security, and improve the returns on policy investments in the DPR, China needs to adapt its environmental programmes to address the potential impacts of future climate change and create positive synergies to combat desertification and improve the economy in this region.
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Project description:Prior to 2010, Medicare payments for consultations (commonly billed by specialists) were substantially higher than for office visits of similar complexity (commonly billed by primary care physicians). In January 2010, Medicare eliminated consultation payments from the Part B Physician Fee Schedule and increased fees for office visits. This change was intended to be budget neutral and to decrease payments to specialists while increasing payments to primary care physicians. We assessed the impact of this policy on spending, volume, and complexity for outpatient office encounters in 2010.We examined outpatient claims from 2007 through 2010 for 2 247 810 Medicare beneficiaries with Medicare Supplemental (Medigap) coverage through large employers in the Thomson Reuters MarketScan Database. We used segmented regression analysis to study changes in spending, volume, and complexity of office encounters adjusted for age, sex, health status, secular trends, seasonality, and hospital referral region."New" office visits largely replaced consultations in 2010. An average of $10.20 more was spent per beneficiary per quarter on physician encounters after the policy (6.5% increase). The total volume of physician encounters did not change significantly. The increase in spending was largely explained by higher office-visit fees from the policy and a shift toward higher-complexity visits to both specialists and primary care physicians.The elimination of consultations led to a net increase in spending on visits to both primary care physicians and specialists. Higher prices, partially owing to the subjectivity of codes in the physician fee schedule, explained the spending increase, rather than higher volumes.
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Project description:BackgroundThe Open Biomedical Ontologies (OBO) Foundry is a collection of freely available ontologically structured controlled vocabularies in the biomedical domain. Most of them are disseminated via both the OBO Flatfile Format and the semantic web format Web Ontology Language (OWL), which draws upon formal logic. Based on the interpretations underlying OWL description logics (OWL-DL) semantics, we scrutinize the OWL-DL releases of OBO ontologies to assess whether their logical axioms correspond to the meaning intended by their authors.ResultsWe analyzed ontologies and ontology cross products available via the OBO Foundry site http://www.obofoundry.org for existential restrictions (someValuesFrom), from which we examined a random sample of 2,836 clauses.According to a rating done by four experts, 23% of all existential restrictions in OBO Foundry candidate ontologies are suspicious (Cohens' ? = 0.78). We found a smaller proportion of existential restrictions in OBO Foundry cross products are suspicious, but in this case an accurate quantitative judgment is not possible due to a low inter-rater agreement (? = 0.07). We identified several typical modeling problems, for which satisfactory ontology design patterns based on OWL-DL were proposed. We further describe several usability issues with OBO ontologies, including the lack of ontological commitment for several common terms, and the proliferation of domain-specific relations.ConclusionsThe current OWL releases of OBO Foundry (and Foundry candidate) ontologies contain numerous assertions which do not properly describe the underlying biological reality, or are ambiguous and difficult to interpret. The solution is a better anchoring in upper ontologies and a restriction to relatively few, well defined relation types with given domain and range constraints.
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Project description:Controlling the spread of COVID-19 - even after a licensed vaccine is available - requires the effective use of non-pharmaceutical interventions, e.g., physical distancing, limits on group sizes, mask wearing, etc1-7. To date, such interventions have not been uniformly and/or systematically implemented across the United States of America (US)8. For example, even when under strict stay-at-home orders, numerous jurisdictions in the US granted exceptions and/or were in close proximity to locations with entirely different regulations in place. Here, we investigate the impact of such geographic inconsistencies in epidemic control policies by coupling high-resolution mobility, search, and COVID case data to a mathematical model of SARS-CoV-2 transmission. Our results show that while stay-at-home orders decrease contacts in most areas of the US, some specific activities and venues often see an increase in attendance. As an example, over the month of March 2020, between 10 and 30% of churches in the US saw increases in attendance; even as the total number of visits to churches declined nationally. This heterogeneity, where certain venues see substantial increases in attendance while others close, suggests that closure can cause individuals to find an open venue, even if that requires longer-distance travel. And, indeed, the average distance travelled to churches in the US rose by 13% over the same period, and over the summer, churches with more than 50 average weekly visitors saw an increase of 81% in distance visitors had to travel to attend. Strikingly, our mathematical model reveals that, across a broad range of model parameters, partial measures can often be worse than no measures at all. In the most severe cases, individuals not complying with policies by traveling to neighboring jurisdictions can create epidemics when the outbreak would otherwise have been contained. Indeed, using county-level COVID-19 data, we show that mobility from high-incidence to low-incidence associated with travel for venues like churches, parks, and gyms consistently precedes rising case numbers in the low-incidence counties. Taken together, our data analysis of nearly 120 million church visitors across 184,677 churches, 14 million grocery visitors across 7,662 grocery stores, 13.5 million gym visitors across 5,483 gyms, 7.7 million cases across 3,195 counties, and modeling results highlight the potential unintended consequences of inconsistent epidemic control policies and stress the importance of balancing the societal needs of a population with the risk of an outbreak growing into a large epidemic, and the urgent need for centralized implementation and enforcement of non-pharmaceutical interventions.
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Project description:US immigration enforcement policy seeks to change the behaviors and views of not only individuals in the United States but also those of prospective migrants outside the United States. Yet we still know relatively little about the behavioral and attitudinal effects of US enforcement policy on the population abroad. This study uses a randomized experiment embedded in a nationally representative survey that was administered in El Salvador, Guatemala, Honduras, and Mexico to analyze the effects of US deterrence policies on individuals' migration intentions and their attitudes toward the US immigration system. The two policies that the current study examines are immigration detention and nonjudicial removals. The survey results provide no evidence that a heightened awareness of these US immigration enforcement policies affects individuals' intentions to migrate to the United States. But heightened awareness about the widespread use of immigration detention in the United States does negatively impact individuals' assessments about the procedural and outcome fairness of the US immigration system. These findings suggest that immigration detention may foster delegitimating beliefs about the US legal system without producing the intended deterrent effect.
| S-EPMC8166165 | biostudies-literature