Health affairs
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Pharmaceutical manufacturers have long considered results collected from drugs' clinical trials to be confidential information or trade secrets, even after submission to the Food and Drug Administration (FDA). We describe FDA policies regarding disclosure of clinical trial data and evaluate how courts have interpreted the Freedom of Information Act in cases seeking access to unreleased information. Recent examples of approved drugs later found to have dangerous side effects show the importance of complete dissemination of safety information. We suggest regulatory and legislative policy changes regarding how the FDA handles confidential information that can improve understanding of the risks of prescription drugs.
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The increasing prevalence of overweight children and adolescents in the United States threatens the well-being of a vast segment of this population. This paper examines how U. ⋯ We describe a variety of innovative initiatives launched in recent years by health plans to address overweight among children and adolescents. Despite gaps in the evidence base, enough is now known to support aggressive steps to control this important public health problem.
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Insurers are well positioned to support their enrollees in shopping for care because of their ability to analyze complex data--reflecting both their negotiated discounts and the enrollee's benefit structure--should they decide to commit resources to this task. Government transparency initiatives can help those who are uninsured or want to use out-of-network providers with data on prices and all patients by gathering and disseminating data on quality. But clumsy requirements to disclose insurer-provider contracts could lead to higher prices. Greater price transparency might help curb rising costs, but many overstate the likely magnitude of its contribution.
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Despite the urgent call to action made by the Institute of Medicine's (IOM's) Crossing the Quality Chasm report in 2001, several fundamental issues in health care remain largely unaddressed. Although a number of organizations have addressed many of the system-level factors cited in the report, we have much to learn about practice and patient factors that affect clinical outcomes. Now we have new opportunities to further improve health care by learning from the data available in electronic health record databases and, perhaps more importantly, to better understand the human behavior of caregivers and patients necessary to improve health care quality.
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State and federal initiatives to enact medical malpractice tort reforms lack an empirical basis for understanding how reforms might affect malpractice premiums and costs. This paper ranks each state's tort provisions, uses multivariate analysis to measure the effects of strong versus weak enactments on paid claims, and identifies tort law patterns associated with high and low claims frequency and payment levels. Our results suggest that (1) the size and number of medical malpractice payments are affected by only some tort reforms; and (2) the pattern of reforms differs between states with high versus low levels of claims or payments.