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U.S. Food and Drug Administration

The Office of Women's Health Scientific Research Program

Outcomes

Publications
From OWH Funded Projects
By Fiscal Year of Funding

FISCAL YEAR 1994

Principle Investigator - Norcross
"Cryptic nature of envelope V3 Region epitopes protects primary monocytotropic Human Immunodeficiency Virus Type 1 from Antibody Neutralization." Dumith Chequer Bou-Habib, et al. Journal of Virology, Sept., 1994; 68 (3).

Principle Investigator - Norcross
"Mediation of human immunodeficiency virus type 1 binding by interaction of cell surface heparan sulfate proteoglycans with the V3 region of envelope gp120-gp41." Roderigues, et at. Journal of Virology, Apr 1995; 69 (4): 2233-2239

Principle Investigator - Sheehan
"ICI 182,780 inhibits endogenous estrogen-dependent rat uterine growth and Tamoxifen-induced developmental toxicity." William S. Branham, et al. Biology of Reproduction, 1995; 54: 160-167

Principle Investigator - Sheehan
"Effects of Tormifene on neonatal rate uterine growth and differentiation." Kevin L. Medlock, et al. Biology of Reproduction, 1997;56.

Principle Investigator - Fein
"Risk of diarrhea related to iron content of infant formula: lack of evidence to support the use of low-iron formula as a supplement for breastfed infants." Paula D. Scariati, et al Pediatrics, March, 1997; 99 (3).

Prinicipal Investigator - Trapnell
"Quantitation of vaginal administered Nonoxynol-9 in premenopausal women." Patricia Barditch-Corvo, et al. Contraception, 1997;55.

Principle Investigator - Woosley
"Sex hormone prolong the QT Interval and downregulate potassium channel expression in the rabbit heart." Milou D. Drici, et al. Circulation, Sept., 15, 1996; 94 (6).


FISCAL YEAR 1995

Principal Investigator - James
"Characterization of cellular response to silicone implants in rats: implications for foreign-body carcinogenesis." S. Jill James, et al. Biomaterials, 1997; 18 (9).

Principal Investigator - Finbloom
"Impaired interferon-a-induced signaling in peripheral blood mononuclear cells from patients with SLE and RA." J. of Immunology , 1997

Principle Investigator - Trapnell
"Thalidomide does not affect the pharmacokinetics of ethynil estradiol and norethindrone." C. Trapnell, et al. Clin Pharmacol Ther, Dec 1998, 64 (6): 597-602.

Principle Investigator - Wear
"Assessment of bone density using ultrasonic backscater." Wear and Garra. Ultrasound in Med & Biol, 24 (5): 689-95, 1998.


FISCAL YEAR 1996

Principle Investigator - Beland
"Identification of Tamoxifen-DNA adducts formed by 4-Hydroxytamoxiden Quinone Methide." M. Matilde Marques and Frederick A. Beland. Carcinogenesis, 1997; 18 (10).

Principle Investigator - Tosato
"Mig, the monokine induced by interferon-a. Promotes Tumor Necrosis in vivo." Cecilia Sgadari, et al. Blood. April 15, 1997; 89 (8)/

Principle Investigator - Tosato
"Interferon-inducible protein-10 identified as a mediator of tumor necrosis in vivo." Cecilia Sgadari, et al. Proc. Natl. Acad. Sci, Nov. 1996; 93.

Principle Investigator - Volpe
"Comparative in vitro toxicology of alkylating agents to normal human myeloid progenitor cells." Volpe et al. J of Soc. for in-vitro Biol. 34 (9): Oct 1998

Principle Investigator - Sheehan
"Quantitative structure-activity relationships (QSARs) for estrogen binding to the estrogen receptor: predications across species." Tong W, Perkins R, Strelitz R, Collantes ER, Keenan S, Welsh WJ, Branham WS, Sheehan Dm. Environ. Health Prospect 105:1116-24; 1998.

Principle Investigator - Sheehan
"QSAR models for binding of estrogenic compounds to estrogen receptor alpha and beta subtypes." Tong W, Perkins, Xing L, Welsh WJ, Sheehan Dm. Endocrine. 138:4022-5; 1997.

Principle Investigator - Sheehan
"Evaluation of quantitative structure-activity relationship methods for large-scale prediction of chemicals binding to the estrogen receptor." Tong W, Lowis DR, Perkins R, Chen Y, Welsh WJ, Goddette DW, Heritage TW, Sheehan DM. J. Chem. Inf. Comput. Sci. 38:669-77; 1998.

Principle Investigator - Sheehan
"Estrogen receptor relative binding affinities of 188 natural and xenochemicals: structural diversity of ligands." Blair R, Fang H, Branham WS, Hass B, Dial SL, Moland CL, Tong W, Shi L, Perkins R, Sheehan DM. Toxiol. Sci. 54:138-153; 2000.

Principle Investigator - Sheehan
"Comparison of estrogen receptor alpha and beta subtypes based on comparative molecular field analysis (CoMFSA)." Xing L, Welsh WJ, Tong W, Perkins R, Sheehan Dm SAR/QSAR Environ. Res. 10:215-237; 1999.

Principle Investigator - Sheehan
"Perspectives in three-dimensional quantitative structure-activity relationship (3D-QSAR)/comparative molecular field analysis (CoMFA) in determining estrogenic effects." Tong W, Perkins R, Sheehan DM. Japan Chemistry Today 2:50-57: 1999.

Principle Investigator - Sheehan
"Phytoestrogens and synthetic chemicals as developmental endocrine disruptors." Sheehan DM, Branham WS, Tong W, Perkins R. Newsletter Japan 2:3; 1998.

Principle Investigator - Sheehan
"Quantitative comparison of in vitro assays for estrogenic activity." Fang H, Tong W, Perkins R, Soro A, Prechtl N, Sheehan DM. Environ. Health Perspect.; 2000 (in press).

Principle Investigator - Klinman
"DNase treatment does not improve the survival of lupus prone (NZB x NZW)F1 mice." D. Verthelyi, et al. Lupus. 1998; 7(4) 223-30.


FISCAL YEAR 1997

Principle Investigator - H. Golding
"Expression and function of CCR5 and CXCR4 on human Langerhans cells and macrophages: Implications for HIV primary infection." M. Zaitseva et al. Nature Medicine. 3 (12), Dec 1997

Principle Investigator - H. Golding
" CXCR4 and CCR5 on human thymocytes: biological function and role in HIV-1 infection." M. Zaitseva et al. J of Immunology. 161: 3101-3113, 1998

Principle Investigator - H. Golding
"Cutting Edge: Cytokines regulate expression and function of the HIV coreceptor CXCR4 on human mature dendritic cells." JP Zoeteweij et al. J of Immunology. 161: 3219-3223, 1998

Principle Investigator - H. Golding
"Fusion of monocytes and macrophages with HIV-1 correlates with biochemical properties of CXCR4 and CCR5." C.Laham et at. Nature Medicine. 5 (3), March 99

Principle Investigator - James
"Abnormal folate metabolism and mutation in the methylenetetrahydrofolate reductase gene may be maternal risk factor for Down syndrome." SJ James et al. Am J Clin Nutr, 70: 1-8; 1999

Principle Investigator - James
"A new HPLC method for the simultaneous determination of oxidized and reduced plasma aminothiols using coulometric elctrochemical detection. S Melnyk et al. J of Nutr Biochem. 10: 490-97; 1999

Principle Investigator - James
"Measurement of plasma and intracellular S-adenosylmethionine and S-adenosylhomocysteine utilizing coulometric electrochemical detection: alterations with plasma homocysteine and pyridoxal 5'phosphate concentrations." S Melnyk et al. Clin Chem, 46:2; 265-272; 2000

Principle Investigator - James
"Increase in plasma homocysteine associated with parallel increases in plasma S-adenosylhomocysteine and lymphocyte DNA hypomethylation." P Yi, et al., J Bio Chem, May 2000

Principle Investigator - Szarfman
"A Baysian screening criterion for ranking cell counts in frequency tables derived from large databases, with an application to FDA Spontaneous Reporting system." DuMouchel, et al. The American Statistician, . Aug 1999


FISCAL YEAR 1998

Principle Investigator - Wear
"Frequency dependence of ultrasonic backscatter from human trabecular bone: theory and experiment", K. A. Wear, J. Acoust. Soc. Am, vol. 106, no. 6, 3659-3664, Dec., 1999

Principle Investigator - Wear
"The effects of frequency-dependent attenuation and dispersion on sound speed measurements: applications in human trabecular bone". K. A. Wear, IEEE Trans Ultrason. Ferro. Freq. Cont., 47, 265-273, January, 2000.

Principle Investigator - Wear
"Measurements of phase velocity and group velocity in human calcaneus", K. A. Wear, Ultrasound Med. Biol. 2000 May 1; 26(4): 641-646, vol. 26, no. 3, 469-472, 2000.

Principle Investigator - Wear
"Temperature dependence of ultrasonic attenuation in human calcaneus", K. A. Wear, Ultrasound Med. Biol., vol. 26, no. 3, 469-472, 2000.

Principle Investigator - Wear
"Anisotropy of ultrasonic backscatter and attenuation from human calcaneus: implications for relative roles of absorption and scattering in determining attenuation", K. A. Wear, J. Acoust. Soc. Am., 107(6), June, 2000.

Principle Investigator - Wear
"A model for ultrasonic backscatter from trabecular bone," KA Wear, Proc. IEEE Symp. Ultrason., Lake Tahoe, CA, Oct. 17-21, 1999.

Principle Investigator - Wear
KA Wear, "Variations in transit-time-based ultrasonic velocity estimates in human calcaneus due to frequency-dependent attenuation and dispersion," Proc. SPIE Medical Imaging 2000 Conf, San Diego, CA, Feb. 12-17, 2000.


DRAFT MANUSCRIPTS
FROM OWH FUNDED PROJECTS
BY FISCAL YEAR OF FUNDING 


FISCAL YEAR 1994

Principle Investigator - Miller
"Restricted and shared patterns of T-cell receptor VB-chain gene expression in silicone breast implant capsules and other inflammatory tissues from patients with connective tissue disease." O'Hanlon et al.

Principle Investigator - Miller
"Laser-Raman microprobe identification of inclusions in capsules associated with silicone gel breast implants." J. Centero et al.

Principle Investigator - Miller
"Silicone gel-filled breast and testicular implant capsules: a histologic and immunophenotypic study." S. Abbondanzo et al. Submitted to Modern Pathology


FISCAL YEAR 1995

Principle Investigator - Klinman
"Effects of sex hormones on the activity of cytokine-secreting cells in pre- and post-menopausal women." Submitted to J of Immunology.

Principle Investigator - Ediger
"Raman spectroscopy and silicone quantification." Submitted to Applied Spectroscopy.

Principle Investigator - B. Golding
"Mucosal immunity in mice immunized with HIV-1 peptides conjugated to Brucella abortus." Submitted to AIDS Research and Human Retrovirus.


FISCAL YEAR 1996

Principle Investigator - M. Myers
"The cause of cessation of viral passage through holes in latex condoms." R. Menta, et al. Submitted to J of Natural Rubber Research.

Principle Investigator - Shacter
"Gender differences in the response to acute myocardial infarction: implications of earlier death for men." Wright, et al. Submitted to NEJM.

Principle Investigator - Sheehan
"An Intergrated "Four-Phase" approach priority setting of endocrine disruptors - Part 2: Phase III QSAR models using a large diverse set of estrogens." Shi LM, Fang H, Tong W, Wu J, Perkins R, Blair R, Branham W, Sheehan D. Sunbmitted to Journal Chemical Information and Computer Sciences: 2000.

Principle Investigator - Sheehan
"An integrated "four-phase" approach for priotity setting of endocrine disruptors - Part 1: Phase I and II for prediction of potential estrogenic endocrine disruptor." Shi LM, Tong W, Fang H, Perkins R, Wu J, Tu M, Blair R, Branham W, Waller C, Sheehan D. Submitted to Environ. Health Perspect.; 2000.

Principle Investigator - Brown
Silicone gel breast implant rupture prevalence in a population of women in Birmingham, Alabama. Brown SL, Middleton MS, Berg WA, Soo MS, Pennello G. American Journal of Roentgenology, in press.

Principle Investigator - Brown
Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS. Submitted to J Rheumatology.

Principle Investigator - Brown
Replacement surgery and silicone gel breast implant rupture: Self-report by women after mammoplasty. Brown SL, Pennello G. Submitted to Epidemiology.


FISCAL YEAR 1997

Principle Investigator - Marinac-Dabic
"Impact of gender on the acute and long-term (1 year) outcome following stneting with the Palmaz-Schatz Stent." Marinac-Dabic, et al. Submitted to Am Heart Journal.

Principle Investigator - James
"Measurement of plasma and intracellular s-adenosylmethinine and s-adenosylhomocysteine using coulometric electrochemical detections: changes with plasma honocysteine and B6 levels." S. Melnyk, et al. Submitted to Clin Chemistry.

Principle Investigator - James
"Plymorphisms in genes involved in folate metabolism as maternal risk factors for Down syndrome." C Hobbs, et al., Submitted to Am J Hum Genetics.


FISCAL YEAR 1998

Principle Investigator - Wear
"The relationship between ultrasonic backscatter and bone mineral density in human calcaneus," K. A. Wear and D. W. Armstrong, Accepted for publication in IEEE Trans Ultrason. Ferro. Freq. Cont.

Principle Investigator - Wear
"Relationship of ultrasonic backscatter with ultrasonic attenuation, sound speed, and bone mineral density in human calcaneus", K. A. Wear, and J. Reynolds, Accepted for publication in Ultrasound in Medicine and Biology,- conditioned on adequate response to reviewers' suggestions.

Principle Investigator - Wear
"Ultrasonic attenuation in human calcaneus from 0.2 to 1.7 MHz", K. A. Wear, Submitted to IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control.

Principle Investigator - Wear
"Computer Simulation and Experiments to Investigate Sound-Speed Estimates in Cancellous Bone," K. A. Wear, Submitted to Comp. Sim. Model. Med..


TALKS, PRESENTATIONS & REGULATORY OUTCOMES
OF FDA OWH FUNDED PROJECTS
BY FISCAL YEAR


FISCAL YEAR 1994

Principal Investigator - Merkatz
FDA Regulated Products and Pregnant Women- Conference and Executive Summary, 1995

Principal Investigator - Sierka
MQSA Speakers kit, consumer brochure and logo

Principal Investigator - Bailey
Alpha hydroxy acids (AHA's) and cosmetic information for consumers via the FDA CFSAN website

Principal Investigator - Bailey
AHA Literature Review

Principal Investigator - Merkatz
STD Workshop- Conference and Summary, Winter 1994

Principal Investigator - Fein
Infant Feeding Practices database (collection, support & construction)

Principal Investigator - Langone
"FDA Alternatives to silicone breast implants"- Workshop October 1994

Principal Investigator - James
"Mechanisms of immunotoxicity and carcinogenicity associated with silicone implants" FDA Science Fair, December 1996

Principal Investigator - James
"Mechanisms of immunotoxicity and carcinogenicity associated with silicone implants" Presentation to the Association of Cancer Research, 1997 Annual meeting

Principal Investigator - Leighton.
Book chapter in Hormones and growth factors in development and neoplasia. Chapter title: "Progresterone receptor and development" (Leighton & LL Wei)


FISCAL YEAR 1995

Principal Investigator - Rheinstein.
Research involving human subjects (RIHSC) -workshop

Principal Investigator - Toigo
Women in clinical trials (pilot database)

Principal Investigator - Ward-Groves
Mammography workshops on MQSA facilities

Principal Investigator - Weiss
Profile of Drug Use in Pregnancy in an HMO- summary report


FISCAL YEAR 1996

Principal Investigator - Ediger
"Development of a safe, economical assay for silicone contamination in blood & tissue" Presentation to the Biophonics 1997 Conference, California.

Principal Investigator - Ediger
"Lasers in Medicine and Biology" Presentation, Gordon Conference, July 1996.

Principle Investigator - Toigo
"Eligibility of women to participate in clinical trials: pilot tracking system" Poster at the FDA Forum of Regulatory Sciences, 1997.

Principle Investigator - Toigo
"Eligibility of women to participate in clinical trials" - Oral Presentation to Commissioned Officers; Association of Public Health Conference, June 1998

Principle Investigator - Silberberg
Guidance for Industry: Uniform Contraceptive labeling (chart)

Principle Investigator - Greberman
"The transfer of defence, intelligence and space technologies for early detection and control of cancers in women" Workshop 1996

Principle Investigator - Myers.
"Opportunities for industrial collaboration in contraceptive research" Poster presentation, Durham, N.C. 1996

Principle Investigator - Brown
Silicone gel breast implant rupture. Brown SL, Brinton LA. USPHS Commissioned Officers Association 33rd Annual Meeting, Alexandria, VA, 1998.

Principle Investigator - Brown
Silicone gel breast implant rupture study. Brown SL, Brinton LA. American Public Health Association, 126th Annual Meeting and Exposition, page 179. (November,1998).

Principle Investigator - Brown
Silicone gel breast implant rupture study. Brown SL, Pennello G. 1998 FDA Science Forum (December, 1998).

Principle Investigator - Brown
FDA study on breast implant rupture and self report of resurgery. Brown SL. USPHS Commissined Officers Association 34th Annual Meeting, Alexandria, VA, 1999.

Principle Investigator - Brown
FDA study on breast implant surgery and replacement. Brown SL, Middleton MS, Berg WA , Soo MS, Pennello G. Plastic Surgical Forum 68th Annual Meeting, XXII:179-80.

Principle Investigator - Brown
Silicone gel breast implant rupture prevalence by magnetic resonance imaging (MR) in a population of women in Birmingham, Alabama. Brown SL, Middleton MS, Berg WA Soo MS, Pennello G. 2000 FDA Science Forum

Principle Investigator - Brown
Replacement surgery and silicone gel breast implant rupture:self-report by women after mammoplasty. Brown SL, Pennello G. 2000 FDA Science Forum

Principle Investigator - Brown
Health status in women with silicone gel breast implant rupture or extracapsular silicone. Brown SL, Pennello G, Berg WA, et al. 2000 FDA Science Forum.

Principle Investigator - Brown
Modeling rupture rates of silicone gel breast implants. Pennello G, Brown SL, Natarajan R, Feigal D. 2000 FDA Science Forum.

Principle Investigator - Brown
CDRH Science Seminar Grand Rounds. FDA study on silicone gel breast implant rupture prevalence. Brown SL. March, 2000.

Principle Investigator - Brown
FDA study of silicone gel breast implant rupture. Brown SL. Sixth World Congress Biomaterials Congress. Kamuela, Hawaii. Invited speaker.

Principle Investigator - Brown
Consensus of MR imaging readings for 571 single-lumen silicone gel-filled breast implants in the women's health bBreast implant rupture study Middleton MS, Berg WA, Soo MS, Brown SL, Pennello G. (submitted to Radiological Society of North America - RSNA)

Principle Investigator - Brown
Berg WA, Middleton MS, Soo MS, Brown SL. Consensus evaluations of the MR imaging appearance of soft-tissue extracapsular silicone in the women's health breast implant study for 344 women with 687 single- and double-lumen implants (Submitted to RSNA)

Principle Investigator - Brown
Rupture prevalence and MR imaging appearance of the Hartley double-lumen breast implant. Middleton MS, Soo MS, Berg WA, Brown SL, Pennello G. (Submitted to RSNA)


FISCAL YEAR 1997

Principle Investigator - Marinac-Dabic
"Six month follow up of women treated with the Palmaz-Schatz stent" American Public Health Association Annual meeting, November 1998.

Principle Investigator - Szarfman
"Datamining methods to screen FDA's post-marketing safety database" Seminar to FDA Staff college by William DuMouchel, PhD and Ana Szarfman, Ph.D., MD.

Principle Investigator - Ana Szarfman
"Bayesian datamining in large frequency tables, with an application to the FDA spontaneous reporting system"- A commentary. The American Statistician, August 1999.

Principle Investigator - Marinac-Dabic
"Epidemiology of medical devices used in women" Annuals of Epidemiology and Epidemiology (supplements).

Principle Investigator - Bright
"Does managed care equalized access for poor elderly?: socioeconomic status and utilization in a managed care HMO. Presentation to the 14th International Conference on Pharmacoepidemiology, Fall 1998.


FISCAL YEAR 1998

Principle Investigator - Sheehan
"The Endocrine Disruptor Knowledge Base: A Prototype Toxicological Knowledge Base and Predictive Models for Endocrine Disrupting Componds." Perkins R, Anson JF, Blair R, et. al In: Society of Environmental Toxicology and Chemistry, 8th International Workshop on Quantitative Structure Activity Relationships (QSARs) in the Environmental Sciences, Baltimore, Maryland, 1998.

Principle Investigator - Neunaber Kerr
"Characterization and creation of defects in condoms" Laboratory Information bulletin No. 4-184.

Principle Investigator - Neunaber Kerr
"The Evaluation of various papers for usefulness in condom water leak testing" Laboratory Information bulletin No. 4-152.

Principle Investigator - Neunaber Kerr
"The Evaluation of various papers for usefulness in condom water leak testing" Abstract at the FDA Regulatory Science Forum, Washington, D.C., January 2000.

Principle Investigator - Wear
"Relationship between attenuation and backscatter in trabecular bone", KA Wear, p. 56, Proc. 24th International Symp. On Ultrasonic Imaging and Tissue Characterization, Arlington, VA, June 2-4, 1999.

Principle Investigator - Wear
"Comparison of phase and group velocities in trabecular bone", KA Wear, accepted for presentation at the 25th International Symp. On Ultrasonic Imaging and Tissue Characterization, Arlington, VA, May 22-24, 2000



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