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
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.
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.
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.
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.
"Sickness is pungent, and memory clings to smells in the hospital."
From "The Most Primitive Sense."
Behavioral researchers recommend that control strategies to decrease
ecstasy use among young people focus on improving harm reduction rather than
expanding law enforcement efforts.
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.
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.
In most of Central America, access to HIV-specific health services and
antiretroviral therapy is extremely limited.
For your patients: Information about pacemakers.
This Week in JAMA. JAMA. 2001;286(7):759. doi:10.1001/jama.286.7.759