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This Week in JAMA
August 15, 2001

This Week in JAMA

JAMA. 2001;286(7):759. doi:10.1001/jama.286.7.759
Recall and Safety Alert Trends for Pacemakers and ICDs

The US Food and Drug Administration (FDA) is responsible for the safety and oversight of all medical devices in the United States and issues advisories—recalls and safety alerts—when medical devices are found to malfunction. Maisel and colleaguesArticle analyzed weekly FDA Enforcement Reports issued between January 1990 and December 2000 to determine the rates of recalls and safety alerts for pacemakers and implantable cardioverter-defibrillator (ICD) generators. Fifty-two advisories involving 408 500 pacemakers and 114 645 ICDs were issued during the study period. For both devices, the annual rate of recalls and safety alerts increased significantly between 1995 and 2000. In an editorial, EagleArticle suggests that the frequency of safety alerts and the number of patients involved raise questions about current regulatory efforts surrounding these devices.

Clinical Research at Academic Health Centers

The changing US health care system may be affecting the conduct of clinical research at academic health centers. In this survey of department chairs and senior research administrators at US medical schools, Campbell and colleaguesArticle found that respondents rated clinical research activities as less healthy, of lower quality, and facing greater challenges than nonclinical research. The most frequently identified problems facing clinical research included the pressure on clinical faculty to see patients, insufficient clinical revenues, and difficulty recruiting trained researchers. In an editorial, MillerArticle discusses 2 issues central to the future of clinical research—accountability for resources and training of clinician investigators.

Long-term Effects of Soy-Based Formula on Health

Dietary phytoestrogens, including soy isoflavones, have been shown to influence hormone-dependent states. To determine whether exposure to soy-based infant formula is associated with long-term effects on health, especially reproductive health, Strom and colleagues evaluated adults aged 20 to 34 years who had participated in controlled feeding studies during infancy. Women who had been fed soy formula as infants reported slightly longer duration of menstrual bleeding and greater discomfort with menstruation. For more than 30 other general and reproductive health outcomes, however, no statistically significant differences were observed between the group of adults who had been fed soy-based formula as infants and those who had been fed cow milk formula.

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Effects of HRT on Bone Mineral Density in Elderly Women

Hormone replacement therapy (HRT) is rarely initiated for prevention of osteoporosis in elderly women, and whether HRT will have an osteoprotective effect in elderly women is not known. In this randomized trial among women aged 75 years or older with mild-to-moderate physical frailty, Villareal and colleagues found that increases in bone mineral density of the lumbar spine and total hip were significantly greater in the group that received HRT than in the placebo group after 9 months of treatment.

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Results of Randomized vs Nonrandomized Studies

Results of randomized controlled trials are often considered to be more reliable than results of nonrandomized studies. Ioannidis and colleagues used meta-analyses that included both study designs to compare the results of randomized trials and nonrandomized studies that investigated the efficacy of the same therapeutic or preventive intervention for 45 different medical topics. The summary odds ratios of randomized trials and nonrandomized studies were highly correlated, but nonrandomized studies tended to show larger treatment effects. Discrepancies beyond what could be explained by chance, based on random-effects calculations, occurred in 7 of the 45 topics.

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A Piece of My Mind

"Sickness is pungent, and memory clings to smells in the hospital." From "The Most Primitive Sense."

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Medical News & Perspectives

Behavioral researchers recommend that control strategies to decrease ecstasy use among young people focus on improving harm reduction rather than expanding law enforcement efforts.

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FDA Risk Management

Analysis of claims data indicates that risk management efforts by the US Food and Drug Administration (FDA) failed to achieve adequate rates of liver enzyme testing among patients using troglitazone.

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Strategies to Decrease TB Among Homeless

A computer simulation model suggests that increased treatment access, improvement in treatment effectiveness, and BCG vaccination of HIV-negative homeless individuals are the most promising strategies to decrease tuberculosis (TB) morbidity and mortality in US homeless populations.

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HIV Care in Central America

In most of Central America, access to HIV-specific health services and antiretroviral therapy is extremely limited.

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JAMA Patient Page

For your patients: Information about pacemakers.

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