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Science & Research

Women's Health Science Program (2001 Update to Accomplishments Report)

Update to the Accomplishments Report
June 2001

The Office of Women’s Health Science Program plays an integral role in promoting the development of sound policy and regulation to enhance women’s health. The Science Program responds to pressing women’s health issues identified from within and outside the Agency and funds research to fill the gap between basic research and regulatory decision making. The range of disciplines and research topics represented by the funded projects is diverse and includes: cancer, HIV, cardiovascular disease, osteoporosis, auto-immune disease, dietary supplements, breast implants, dioxins, post-marketing surveillance and statistical approaches to gender analysis. The results of these studies have been published in scientific journals, have provided information for the development of published regulations and guidance and have contributed to outreach programs promoting women’s health.

The Office of Women’s Health (OWH) Science Program is composed of four separate funding mechanisms that include the Intramural Research Program, the Extramural Research Program, Partnership with DHHS Centers for Excellence in Women’s Health and Special Initiatives. These program areas allow the Office to leverage internal and external resources to enhance the science base for women’s health within the Agency. Emphasis is given to projects with the greatest potential for contributing to knowledge of women’s health in a brief time frame and to have a regulatory impact.

This summary report updates the July, 2000 Accomplishments Report and highlights projects funded or completed since the last report. To obtain more information about the Science Program and projects funded by the program, we invite you to read the report in its entirety on the OWH website.

Thank you for your interest in women’s health.

2001 Completed Projects: Intramural and Extramural Research Program

Abrasive wear testing of breast implants -- Patricia Dubill, Ph.D.
Breast implant rupture is a major complication for women having breast implants and leads to several other adverse outcomes including resurgery. Abrasive wear is believed to weaken the implant shell, making it more susceptible to rupture. Most women receiving breast implants have long life expectancies, breast implant durability, including abrasive wear, is a significant concern. To identify the effects of deterioration in strength, breast implant materials were tested under conditions that simulated abrasive wear. The results of these tests can be utilized to establish standardized testing methods to identify the wear characteristics of these products.

Investigation of the potential enhanced exposures of women to estrogens, phytoestrogens, and xenoestrogens through cosmetic products -- Robert Bronaugh, Ph.D.
Estrogenic activity has been identified in a wide range of cosmetics, foods and environmental contaminants. Long-term exposure to estrogen is associated with a higher incidence of breast cancer in women. These studies showed that the exposure to estrogens from most cosmetic products is very low and without detectable estrogenic effects. One of the cosmetic preparations tested could potentially expose women to estrogenically active substances. Further studies on other cosmetics are necessary to identify estrogenic exposure and assess the prevalence and degree of estrogenic activity in topically applied cosmetic products.

Molecular and metabolic determinants of maternal risk and progression of Down Syndrome: potential for nutritional intervention -- Jill James, Ph.D.
Down syndrome is a complex genetic and metabolic disorder attributed to the presence of three copies of chromosome 21. This project identified several genetic factors associated with an increased risk of having a child with Down syndrome and provided new insights into the metabolic pathways that cause the disorder. This work also suggests that adequate folic acid status at least 3 months before conception may reduce the risk of maternal chromosome errors and a Down syndrome conception. These findings may also provide physicians with the ability to develop targeted interventions that will improve the clinical management of children with Down Syndrome.

Development and validation of a universal water test method for condoms -- Lesley Neunaber Kerr, Ph.D.
Barrier contraception is used for the prevention of pregnancy and for protection against sexually transmitted diseases. Water leakage tests effectively test the barrier properties of condoms. The efficacy of the two established water leak test methods was evaluated by comparing the defect detection rate for condoms of various materials and designs. Recommendations were made on how best standardize and improve the water leak test method within the FDA and industry through the ISO/FDA and ASTM standards. Adoption of these standards will permit the FDA to develop guidance for sponsors of these devices.

Variations in the drug-induced QT interval prolongation during the menstrual cycle -- Raymond L. Woosley, MD, Ph.D. and Ana Szarfman, MD, Ph.D.
Contraction of the heart is a coordinated activity of cardiac muscle. When the period between contractions is prolonged the heart may not beat normally, leading to life threatening cardiac arrhythmias. Various medications including the antiarrhythmic drug, ibutilide, prolong the QT interval. The effect of hormonal changes during the menstrual cycle on QT prolongation were evaluated after the administration of ibutilide and compared to the effect observed in men. The women were more likely than men to develop ibutilide induced QT prolongation. This suggests that testosterone protects men against the development of drug-induced arrhythmias.

Data mining techniques for identifying potential serious drug interactions in women -- Ana Szarfman, Ph.D.
This project developed a new approach that rapidly and comprehensively reviews all reported adverse events and identifies those that are more common or more serious in women compared to men. The approach couples a statistical model to the database using visualization tools for a rapid review of results. The serious events that are reported more frequently in women identified by this method include: torsades de pointes (prolongation of QT interval), agranulocytosis, aplastic anemia, bone marrow depression, pancytopenia, leukopenia, hemorrhagic disorders, kidney failure and abnormality of function, pancreatitis and liver failure, hepatitis or other liver abnormality. Causes for gender differences in reported adverse events may be related to biological differences, differential exposures, reporting or interactions between factors.

Special Initiatives

Condom Workshop, June 13, 2000.
This workshop summarized the existing information on the effectiveness of condoms in preventing sexually transmitted disease. The results of this workshop are serving as a basis for rewriting the condom labeling guidelines.

FDA Scholarship in Women’s Health Program. Marion Gruber, Ph.D.
This project examined the extent to which females have been included in clinical trials for biological products and to what extent the data are analyzed for the detection of gender differences. The results indicated that males and females were equally included in clinical trials. Gender analysis, using gender as a demographic variable, was conducted for only a small percentage of clinical trial summaries reviewed. Labeling for gender was generally limited to the pregnancy subsection of the label. This study has contributed to the planning of a clinical trials database intended to monitor inclusion of women in clinical trials

Clinical Pharmacology during Pregnancy, December 4-5, 2000.
This workshop was held to summarize knowledge regarding the effect of physiological changes in pregnancy on the pharmacokinetics and pharmaco-dynamics of medicines needed to treat pregnant women. The presentations described the scientific, medical and ethical issues associated with drug use in pregnancy. Regulators, scientists and ethicists agreed that studies of pregnant women needing chronic therapy were necessary to provide information to guide physicians in drug dosing.

2001 Funded Projects

Intramural and Extramural Science Program

  • Developing a diagnostic gene expression microarray for Type I latex allergy using transcriptome profiling. Rosalie Elespuru, Ph.D.
  • Thymic regeneration and immune reconstitution: Development of animal models to study the role of cytokines and hormonal contributions. Hana Golding, Ph.D.
  • Discovery and evaluation of interspecies biomarkers to identify and characterize the cardiotoxic effects of Trastuzumab (Herceptin), a novel antibody used in the treatment of breast cancer. Eugene Herman, Ph.D.
  • Optimization of UV exposure patterns: Maximizing perceived benefits while minimizing photocarcinogenic and photoaging effects. Sharon Miller, M.S.

Partnership with DHHS Centers of Excellence in Women’s Health

  • Pattern of botanical dietary supplement usage in menopausal women. Gail B. Mahady, Ph.D., University of Illinois at Chicago
  • Effect of dietary soy and calcium supplementation on lipid levels, brachial artery function, biochemical markers of bone turnover, inflammatory markers of atherosclerosis and menopausal symptoms in postmenopausal women. Francine K. Welty, M.D., Ph.D., Beth Israel Deaconess Medical Center and Harvard University
  • The effects of St. Johns Wort on the efficacy of oral contraception. Stephen D. Hall, Ph.D., Indiana University
  • Review of herbal weight loss product experiences and adverse events. Sara L. Warber, M.D., University of Michigan
  • Use and interaction of dietary supplements in the SEA Trial. Mara Vitolins, Dr.P.H., Wake Forest University
  • Phytoestrogens: Drug interaction potential in women. Gail Anderson, Ph.D., University of Washington

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