Maternal asthma, diabetes, and high blood pressure are associated with low birth weight and increased hospital birth and delivery charges; Hawai'i hospital discharge data 2003-2008.

Asthma, diabetes, and high blood pressure are common maternal conditions that can impact birth outcomes. Data from hospital discharges in Hawai'i were analyzed for 107,034 singleton births from 2003-2008. Categories were determined using the International Statistical Classification of Diseases, ninth revision (ICD-9) from linked delivery records of mother and infant. Prevalence estimates of asthma (ICD-9: 493), diabetes (ICD-9: 250,648.0, 648.8), high blood pressure (ICD-9: 401-405,642) as coded on the delivery record, low birth weight (<2500 grams), high birth weight (>4500 grams), Cesarean delivery, and median hospital charges were calculated. Median regression analysis assessed total hospital charges adjusting for maternal age, maternal race, insurance, and Cesarean delivery. Maternal asthma was present in 4.3% (95% confidence interval=4.1-4.4%), maternal diabetes was present in 7.7% (95% CI=7.6-7.9%), and maternal high blood pressure was present in 9.2% (95% CI=9.0-9.3%) of births. In the adjusted median regression analysis, mothers with asthma had $999 (95% CI: $886 to $1,112) higher hospital charges compared to those without; mothers with diabetes had $743 (95% CI: $636 to $850) higher charges compared to those without; and mothers with high blood pressure had $2,314 (95% CI: $2,194 to $2,434) higher charges compared to those without. Asthma, diabetes, and high blood pressure are associated with higher hospital delivery charges and low birth weight. Diabetes and high blood pressure were also associated with Cesarean delivery. An increased awareness of the impact of these conditions on both adverse birth outcomes and the development of chronic disease is needed.

Medical device development: managing conflicts of interest encountered by physicians.

New technologies introduced over the past three decades have transformed medical diagnosis and treatment, and significantly improved patient outcomes. These changes have been mediated by the introduction of new medical devices, particularly for the treatment of cardiovascular, orthopedic, and ophthalmic disorders. These devices, in turn, have created large markets and spawned a burgeoning medical device industry, including six Fortune 500 companies whose combined market capitalization now exceeds 400 billion dollars. This success story, which has unquestionably benefited patients and society alike, has been dependent upon an intense collaboration among industry, clinicians, and regulatory authorities. However, when physicians actively involved in patient care participate in such collaborations, they are increasingly vulnerable to creating potential conflicts between these two (clinical and device development) roles. Such conflicts, which may ultimately erode public trust, have important consequences not only for the individual physicians, but also for their parent institutions, their patients, sponsoring companies, and the entire clinical research enterprise that makes the development and introduction of new devices possible. The third Dartmouth Device Development Symposium held in October 2005 brought together thought leaders within the medical device community, including academicians, clinical investigators, regulators from the Food and Drug Administration and Centers for Medicare and Medicaid Services (CMS), large and small device manufacturers and the financial (venture capital and investment banks) community. The Symposium examined the conflicts of interest encountered during the early development and commercialization of a medical device. The goal of these discussions was to (1) identify and characterize the conflicts that arise and (2) provide strategies to address these conflicts. This manuscript was prepared by a writing committee to provide a summary report of those discussions.

Medical applications of microarray technologies: a regulatory science perspective.

The potential medical applications of microarrays have generated much excitement, and some skepticism, within the biomedical community. Some researchers have suggested that within the decade microarrays will be routinely used in the selection, assessment, and quality control of the best drugs for pharmaceutical development, as well as for disease diagnosis and for monitoring desired and adverse outcomes of therapeutic interventions. Realizing this potential will be a challenge for the whole scientific community, as breakthroughs that show great promise at the bench often fail to meet the requirements of clinicians and regulatory scientists. The development of a cooperative framework among regulators, product sponsors, and technology experts will be essential for realizing the revolutionary promise that microarrays hold for drug development, regulatory science, medical practice and public health.