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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.

Ebola Virus Disease in West Africa — The First 9 Months of the Epidemic and Forward Projections

October 24, 2014 Comments off

Ebola Virus Disease in West Africa — The First 9 Months of the Epidemic and Forward Projections
Source: New England Journal of Medicine

As of September 14, 2014, a total of 4507 confirmed and probable cases of Ebola virus disease (EVD), as well as 2296 deaths from the virus, had been reported from five countries in West Africa — Guinea, Liberia, Nigeria, Senegal, and Sierra Leone. In terms of reported morbidity and mortality, the current epidemic of EVD is far larger than all previous epidemics combined. The true numbers of cases and deaths are certainly higher. There are numerous reports of symptomatic persons evading diagnosis and treatment, of laboratory diagnoses that have not been included in national databases, and of persons with suspected EVD who were buried without a diagnosis having been made

Ebola Virus Disease in West Africa — The First 9 Months of the Epidemic and Forward Projections

September 24, 2014 Comments off

Ebola Virus Disease in West Africa — The First 9 Months of the Epidemic and Forward Projections
Source: New England Journal of Medicine

A total of 4507 confirmed and probable EVD cases were reported to the WHO between December 30, 2013, and September 14, 2014 — a 37-week period. A total of 718 confirmed and probable cases and 289 deaths were reported in the week of September 8 through September 14 alone. The numbers of confirmed and probable cases reported by each country over time are shown in Figure 1 and Figure 2. Detailed information was available on 3343 confirmed and 667 probable cases; these cases were used in all our analyses, with the exception of projections (results of analyses based on confirmed, probable, and suspected cases are provided in Supplementary Appendix 1). The median age of persons with EVD was 32 years (interquartile range, 21 to 44), and there were no significant differences in the age distribution of persons with EVD among countries. The majority of persons with EVD (60.8%) were between 15 and 44 years of age (this age group makes up only 44% of the population) (Table 1Table 1Demographic Characteristics and Signs and Symptoms in Confirmed and Probable Ebola Case Patients with a Definitive Clinical Outcome in Guinea, Liberia, Nigeria, and Sierra Leone.). There were also no significant differences among countries in the total numbers of male and female persons with EVD reported (49.9% of the total were male patients; within-country differences have not yet been fully investigated). EVD has taken a heavy toll among health care workers in Guinea, Liberia, and Sierra Leone. By September 14, a total of 318 cases, including 151 deaths, had been reported among health care workers.

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