A JAMA THEME ISSUE
Edited by Catherine D. DeAngelis, MD, MPH, Phil B. Fontanarosa, MD, MBA, and Drummond Rennie, MD
Biologicals—medications in which the active substance is produced by or extracted from a biological source—are known to have potential safety risks. In a systematic search of Web sites maintained by the US Food and Drug Administration and the European Medicines Agency, Giezen and colleagues Article investigated the nature, frequency, and timing of safety-related regulatory actions for biologicals. The authors report that 41 of 174 biologicals (23.6%) approved since 1995 were the subject of 82 safety-related regulatory actions. These actions were often the result of adverse immunomodulatory effects and involved biologicals first to be approved in a class. In an editorial, DeAngelis and Fontanarosa Article discuss the drug approval process, remedies afforded through products liability law, and potential consequences of preempting tort litigation.
In an analysis of data from the American Heart Association's Get With the Guidelines Program, Mehta and colleagues assessed the degree to which hospital process performance ratings and eligibility for financial incentives are altered after accounting for hospital-specific patient demographics, clinical characteristics, and mix of treatment opportunities. The authors found that compared with unadjusted rankings, accounting for patient characteristics and treatment opportunities was associated with modest changes in hospital performance rankings and eligibility for financial incentives in this pay-for-performance program.
When entire families lack health insurance, children may be eligible for insurance through the State Children's Health Insurance Program. Little is known, however, about the characteristics of families with uninsured children and at least 1 insured parent. In an analysis of nationally representative survey data collected in 2002 through 2005, DeVoe and colleagues assessed predictors of uninsurance among children with at least 1 insured parent. The authors found that approximately 3% of US children were uninsured and had an insured parent. Factors associated with child uninsurance include having low- or middle-household income, being of Hispanic origin, having parents who did not complete high school, and living in a single-parent household.
Emergency departments (EDs) provide care for an increasing number of patients and are often cited as the provider of last resort for uninsured patients. Interventions to relieve demand on EDs may be based on assumptions about the uninsured, but the accuracy of these assumptions has not been assessed. In a systematic review of the literature, Newton and colleagues identified common statements about adult uninsured patients in EDs that appeared without citation or were not based on data provided and compared these statements with the best available evidence on the topic. The authors found that many common assumptions regarding the uninsured—including their contribution to ED overcrowding and the acuity of their medical needs—were not evidence based.
Presidential candidates John McCain Article and Barack Obama Article outline their proposals to ensure that all Americans have access to affordable and quality health care. To vote for the proposal you prefer, go to http://jama.com/vote. Photo credits: Left, John McCain 2008; right, Office of Senator Barack Obama
“I knew that time was running out, and standing by watching him die, only because he had no insurance, became intolerable.” From “Remembering Earl.”
As the cost of health insurance continues to outpace inflation in the United States, even those workers with coverage are burdened with costlier premiums and out-of-pocket expenses for medical care.
Tax reform to drive health care reform
States' role in health care reform
Comparison of US and Canadian health care systems
Ethics and practicalities of selling a medical school's name
Perspectives on the future of the nation's health from this issue's editors.
Join Rita F. Redberg, MD, MSc, November 19 from 2 to 3 PM eastern time to discuss stress testing to document ischemia before PCI. To register, go to http://www.ihi.org/AuthorintheRoom.
For your patients: Information about quality of care.
This Week in JAMA . JAMA. 2008;300(16):1845. doi:10.1001/jama.2008.517