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Association of Improved Air Quality with Lung Development in Children

April 20, 2015 Comments off

Association of Improved Air Quality with Lung Development in Children
Source: New England Journal of Medicine

Background
Air-pollution levels have been trending downward progressively over the past several decades in southern California, as a result of the implementation of air quality–control policies. We assessed whether long-term reductions in pollution were associated with improvements in respiratory health among children.

Methods
As part of the Children’s Health Study, we measured lung function annually in 2120 children from three separate cohorts corresponding to three separate calendar periods: 1994–1998, 1997–2001, and 2007–2011. Mean ages of the children within each cohort were 11 years at the beginning of the period and 15 years at the end. Linear-regression models were used to examine the relationship between declining pollution levels over time and lung-function development from 11 to 15 years of age, measured as the increases in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) during that period (referred to as 4-year growth in FEV1 and FVC).

Results
Over the 13 years spanned by the three cohorts, improvements in 4-year growth of both FEV1 and FVC were associated with declining levels of nitrogen dioxide (P<0.001 for FEV1 and FVC) and of particulate matter with an aerodynamic diameter of less than 2.5 μm (P= 0.008 for FEV1 and P<0.001 for FVC) and less than 10 μm (P<0.001 for FEV1 and FVC). These associations persisted after adjustment for several potential confounders. Significant improvements in lung-function development were observed in both boys and girls and in children with asthma and children without asthma. The proportions of children with clinically low FEV1 (defined as <80% of the predicted value) at 15 years of age declined significantly, from 7.9% to 6.3% to 3.6% across the three periods, as the air quality improved (P=0.001).

Conclusions
We found that long-term improvements in air quality were associated with statistically and clinically significant positive effects on lung-function growth in children. (Funded by the Health Effects Institute and others.)

Genetically Determined Height and Coronary Artery Disease

April 10, 2015 Comments off

Genetically Determined Height and Coronary Artery Disease
Source: New England Journal of Medicine

BACKGROUND
The nature and underlying mechanisms of an inverse association between adult height and the risk of coronary artery disease (CAD) are unclear.

METHODS
We used a genetic approach to investigate the association between height and CAD, using 180 height-associated genetic variants. We tested the association between a change in genetically determined height of 1 SD (6.5 cm) with the risk of CAD in 65,066 cases and 128,383 controls. Using individual-level genotype data from 18,249 persons, we also examined the risk of CAD associated with the presence of various numbers of height-associated alleles. To identify putative mechanisms, we analyzed whether genetically determined height was associated with known cardiovascular risk factors and performed a pathway analysis of the height-associated genes.

RESULTS
We observed a relative increase of 13.5% (95% confidence interval [CI], 5.4 to 22.1; P<0.001) in the risk of CAD per 1-SD decrease in genetically determined height. There was a graded relationship between the presence of an increased number of height-raising variants and a reduced risk of CAD (odds ratio for height quar-tile 4 versus quartile 1, 0.74; 95% CI, 0.68 to 0.84; P<0.001). Of the 12 risk factors that we studied, we observed significant associations only with levels of low-density lipoprotein cholesterol and triglycerides (accounting for approximately 30% of the association). We identified several overlapping pathways involving genes associated with both development and atherosclerosis.

CONCLUSIONS
There is a primary association between a genetically determined shorter height and an increased risk of CAD, a link that is partly explained by the association between shorter height and an adverse lipid profile. Shared biologic processes that determine achieved height and the development of atherosclerosis may explain some of the association. (Funded by the British Heart Foundation and others.)

Randomized Trial of Peanut Consumption in Infants at Risk for Peanut Allergy

February 24, 2015 Comments off

Randomized Trial of Peanut Consumption in Infants at Risk for Peanut Allergy
Source: New England Journal of Medicine

Background
The prevalence of peanut allergy among children in Western countries has doubled in the past 10 years, and peanut allergy is becoming apparent in Africa and Asia. We evaluated strategies of peanut consumption and avoidance to determine which strategy is most effective in preventing the development of peanut allergy in infants at high risk for the allergy.

Methods
We randomly assigned 640 infants with severe eczema, egg allergy, or both to consume or avoid peanuts until 60 months of age. Participants, who were at least 4 months but younger than 11 months of age at randomization, were assigned to separate study cohorts on the basis of preexisting sensitivity to peanut extract, which was determined with the use of a skin-prick test — one consisting of participants with no measurable wheal after testing and the other consisting of those with a wheal measuring 1 to 4 mm in diameter. The primary outcome, which was assessed independently in each cohort, was the proportion of participants with peanut allergy at 60 months of age.

Results
Among the 530 infants in the intention-to-treat population who initially had negative results on the skin-prick test, the prevalence of peanut allergy at 60 months of age was 13.7% in the avoidance group and 1.9% in the consumption group (P<0.001). Among the 98 participants in the intention-to-treat population who initially had positive test results, the prevalence of peanut allergy was 35.3% in the avoidance group and 10.6% in the consumption group (P=0.004). There was no significant between-group difference in the incidence of serious adverse events. Increases in levels of peanut-specific IgG4 antibody occurred predominantly in the consumption group; a greater percentage of participants in the avoidance group had elevated titers of peanut-specific IgE antibody. A larger wheal on the skin-prick test and a lower ratio of peanut-specific IgG4:IgE were associated with peanut allergy.

Conclusions
The early introduction of peanuts significantly decreased the frequency of the development of peanut allergy among children at high risk for this allergy and modulated immune responses to peanuts. (Funded by the National Institute of Allergy and Infectious Diseases and others; ClinicalTrials.gov number, NCT00329784.)

Using Drugs to Discriminate — Adverse Selection in the Insurance Marketplace

February 4, 2015 Comments off

Using Drugs to Discriminate — Adverse Selection in the Insurance Marketplace
Source: New England Journal of Medicine

Eliminating discrimination on the basis of preexisting conditions is one of the central features of the Affordable Care Act (ACA). Before the legislation was passed, insurers in the nongroup market regularly charged high premiums to people with chronic conditions or denied them coverage entirely. To address these problems, the ACA instituted age-adjusted community rating for premiums and mandated that plans insure all comers. In combination with premium subsidies and the Medicaid expansion, these policies have resulted in insurance coverage for an estimated 10 million previously uninsured people in 2014.

There is evidence, however, that insurers are resorting to other tactics to dissuade high-cost patients from enrolling. A formal complaint submitted to the Department of Health and Human Services (HHS) in May 2014 contended that Florida insurers offering plans through the new federal marketplace (exchange) had structured their drug formularies to discourage people with human immunodeficiency virus (HIV) infection from selecting their plans. These insurers categorized all HIV drugs, including generics, in the tier with the highest cost sharing.

Insurers have historically used tiered formularies to encourage enrollees to select generic or preferred brand-name drugs instead of higher-cost alternatives. But if plans place all HIV drugs in the highest cost-sharing tier, enrollees with HIV will incur high costs regardless of which drugs they take. This effect suggests that the goal of this approach — which we call “adverse tiering” — is not to influence enrollees’ drug utilization but rather to deter certain people from enrolling in the first place.

High-Cost Generic Drugs — Implications for Patients and Policymakers

November 18, 2014 Comments off

High-Cost Generic Drugs — Implications for Patients and Policymakers
Source: New England Journal of Medicine

It is well known that new brand-name drugs are often expensive, but U.S. health care is also witnessing a lesser-known but growing and seemingly paradoxical phenomenon: certain older drugs, many of which are generic and not protected by patents or market exclusivity, are now also extremely expensive. Take the case of albendazole, a broad-spectrum antiparasitic medication. Albendazole was first marketed by a corporate predecessor to GlaxoSmithKline (GSK) outside the United States in 1982 and was approved by the Food and Drug Administration (FDA) in 1996. Its patents have long since expired, but no manufacturer ever sought FDA approval for a generic version. One reason may be that the primary indications for the drug — intestinal parasites, neurocysticercosis, and hydatid disease — occur relatively rarely in the United States and usually only in disadvantaged populations such as immigrants and refugees. In late 2010, the listed average wholesale price (AWP) for albendazole was $5.92 per typical daily dose in the United States and less than $1 per typical daily dose overseas.

By 2013, the listed AWP for albendazole had increased to $119.58 per typical daily dose.1 We found that at some pharmacies in Minnesota, an uninsured patient requiring 6 months of treatment would have faced costs amounting to tens of thousands of dollars.1 Although the AWP may not reflect the actual cost of the product, Medicaid data show that spending on albendazole increased from less than $100,000 per year in 2008, when the average cost was $36.10 per prescription, to more than $7.5 million in 2013, when the average cost was $241.30 per prescription (see graph).

The albendazole story is not unique. According to the National Average Drug Acquisition Cost pricing file, the price of captopril (12.5 mg), which is used for hypertension and heart failure, increased by more than 2800% between November 2012 and November 2013, from 1.4 cents to 39.9 cents per pill. Similarly, the price of clomipramine (25 mg), a long-established tricyclic antidepressant also used for obsessive–compulsive disorder, increased from 22 cents to $8.32 per pill, and the price of doxycycline hyclate (100 mg), a broad-spectrum antibiotic that has been around since 1967, increased from 6.3 cents to $3.36 per pill.2

Yet many of these drugs remain key therapeutic tools. The number of prescriptions for albendazole has increased dramatically, in part because the drug has increasingly been used to treat parasitic infections in refugees. The Centers for Disease Control and Prevention recommends presumptive treatment of refugees arriving in the United States if they have not had prior treatment. Because the people who need albendazole are generally disadvantaged, the costs resulting from the enhanced demand and associated price increases are largely borne by the patients themselves through substantial out-of-pocket payments or by taxpayers through public insurers such as Medicaid and the Refugee Medical Assistance program.

Voters and the Affordable Care Act in the 2014 Election

October 31, 2014 Comments off

Voters and the Affordable Care Act in the 2014 Election
Source: New England Journal of Medicine

As we approach the 2014 election, we are witnessing an unusual situation. Poll results suggest a low level of public interest and a low projected voter turnout in this election. Only about half (52%) of the public say they are currently paying attention to the election (CBS News–New York Times [CBS-NYT] poll, 2014). On the basis of past nonpresidential-year elections, less than half of U.S. adults are expected to vote.1 At the same time, congressional candidates are raising a number of important national issues, including what should be the future of the Affordable Care Act (ACA) in the years ahead.

Most Democratic candidates hold positions in favor of continuing the next phase of the ACA’s implementation mostly in its current form, whereas most Republican candidates have positions favoring some sort of major scaling back, repeal, or replacement of the legislation. For a number of different reasons, political forecasters see this election’s outcome as being very close. They give at least an even chance that the Republican Party will win majorities in both the House of Representatives and the Senate. The uncertain outcome of this election has importance for health care because of the polarized views held by each party’s candidates on the future of the ACA, federal health spending, and policies regarding federal health care regulation.

This article, which is based on an analysis of data from 27 public opinion polls by 14 organizations, seeks to examine the role of the ACA in the 2014 election and the potential implications for health care depending on the outcome. It examines the following six questions: How important is health care, and specifically the ACA, as an issue in the 2014 election? If a congressional candidate supports the ACA, are voters more or less likely to vote for him or her? What is the current level of voter support for the ACA? How does this support vary according to voters’ partisan affiliation? Do voters currently support a core principle of the ACA that it is the responsibility of the federal government to make sure that all Americans have health care coverage? What do voters want the next Congress to do with the ACA?

Provision of No-Cost, Long-Acting Contraception and Teenage Pregnancy

October 30, 2014 Comments off

Provision of No-Cost, Long-Acting Contraception and Teenage Pregnancy
Source: New England Journal of Medicine

We found that pregnancy, birth, and abortion rates were low among teenage girls and women enrolled in a project that removed financial and access barriers to contraception and informed them about the particular efficacy of LARC methods. The observed rates of pregnancy, birth, and abortion were substantially lower than national rates among all U.S. teens, particularly when compared with sexually experienced U.S. teens. Stratification according to factors known to be associated with sexual behavior and pregnancy risk (age and race)21 showed that this was true among both older teens (18 to 19 years of age) and younger teens, as well as among both white and black teens.

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