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The historical precedent underway in women's health research in the 1990s provides the basis for more equitable health promotion and disease prevention and treatment of women in the second millennium. The success of this enterprise rests on the collaboration and cooperation of all concerned--the scientific community, health care providers, and the women themselves. The goal is improved health and prevented disease for all women. Thucydides avowed that "history is philosophy learned from examples." We can do no less.
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The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the National Institutes of Health's National Institute of Dental Research (NIDR) and three of FDA's line organizations: the Center for Devices and Radiological Health, the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research. The purpose of the MOU is to facilitate interactions between NIDR and FDA regarding improvements in the quality and relevance of preclinical and clinical research, which is directed to the development of products for use in oral healthcare.
BACKGROUND: Coronary angiography is one of the most frequently performed procedures in women; however, nonobstructive (ie, < 50% stenosis) coronary artery disease (CAD) is frequently reported. Few data exist regarding the type and intensity of resource consumption in women with chest pain after coronary angiography. METHODS AND RESULTS: A total of 883 women referred for coronary angiography were prospectively enrolled in the National Institutes of Health--National Heart, Lung, and Blood Institute--sponsored Women's Ischemia Syndrome Evaluation (WISE). Cardiovascular prognosis and cost data were collected. Direct (hospitalizations, office visits, procedures, and drug utilization) and indirect (out-of-pocket, lost productivity, and travel) costs were estimated through 5 years of follow-up. Among 883 women, 62%, 17%, 11%, and 10% had nonobstructive and 1-vessel, 2-vessel, and 3-vessel CAD, respectively. Five-year cardiovascular death or myocardial infarction rates ranged from 4% to 38% for women with nonobstructive to 3-vessel CAD (P < 0.0001). Five-year rates of hospitalization for chest pain occurred in 20% of women with nonobstructive CAD, increasing to 38% to 55% for women with 1-vessel to 3-vessel CAD (P < 0.0001). The volume of repeat catheterizations or angina hospitalizations was 1.8-fold higher in women with nonobstructive versus 1-vessel CAD after 1 year of follow-up (P < 0.0001). Drug treatment was highest for those with nonobstructive or 1-vessel CAD (P < 0.0001). The proportion of costs for anti-ischemic therapy was higher for women with nonobstructive CAD (15% versus 12% for 1-vessel to 3-vessel CAD; P = 0.001). For women with nonobstructive CAD, average lifetime cost estimates were $767,288 (95% CI, $708,480 to $826,097) and ranged from $1,001,493 to $1,051,302 for women with 1-vessel to 3-vessel CAD (P = 0.0003). CONCLUSIONS: Symptom-driven care is costly even for women with nonobstructive CAD. Our lifetime estimates for costs of cardiovascular care identify a significant subset of women who are unaccounted for within current estimates of the economic burden of coronary heart disease.
The final rule allows the Department of Defense to waive normal requirements so that covered beneficiaries can participate in Phase II and Phase III clinical trials sponsored or approved by the National Institutes of Health National Cancer Institute (NIH NCI). This waiver authority is expected to promote beneficiary access to promising new treatments and contribute to the development of such treatments.
This manuscript is a summary of a comprehensive report dealing with asthma and pregnancy issued by the working group on Asthma and Pregnancy, National Institutes of Health (NIH), National Heart, Lung, and Blood Institute. The report was developed by a panel of obstetricians, pharmacologists, internists, allergists, and pulmonologists, who met over an 18-month period under the auspices of the NIH. Undertreatment of pregnant asthmatics, partially because of unfounded fears of adverse pharmacologic effects on the developing fetus, remains the major problem in the management of asthma during pregnancy in the United States. The four key components of asthma management during pregnancy are: 1) objective assessment of maternal lung function and fetal well-being, 2) avoidance or control of environmental precipitating factors, 3) pharmacologic therapy, and 4) patient education.
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