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Public Health Reports Webinar on Progress in Womens Health: 1985 - 2015 April 7 th, 2015 | 1:00 PM 2:00 PM ET Thank you for joining, the presentation will begin shortly.

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Welcome to the Public Health Reports Meet the Author Webinar on Progress in Womens Health: 1985 - 2015 Frederic E. Shaw, MD, JD Senior Advisor, Center for Surveillance, Epidemiology, and Laboratory Services Office of Public Health Scientific Services, Centers for Disease Control and Prevention Department of Health and Human Services Acting Editor, Public Health Reports

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Progress in Womens Health: 1985 - 2015 Nancy C. Lee, M.D. Deputy Assistant Secretary for Health Women's Health Director, Office on Women's Health U.S. Department of Health and Human Services Public Health Reports Meet the Author! Live Webcast

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Progress in Womens Health

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Why Focus on Womens Health? Often, specific health conditions act differently in women and men Example: a heart attack in a woman is often different from a heart attack in a man Women have more nontraditional symptoms Women are more likely to die after a heart attack USPSTF recommendation for aspirin as a prevention is different for men and women

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30 Achievements in Womens Health in 30 Years 1.Affordable Care Act Improves Womens Health 2.Increasing Womens Lifespan 3.Improvements in Breast Cancer Screening 4.Decrease in Breast Cancer Deaths 5.Decrease in Smoking Rates in Women 6.Decrease in Lung Cancer Deaths in Women 7.Cervical Cancer Prevention and Screening 8.Decrease in HIV/AIDS Deaths in Women 9.Decrease Mother-to-child Transmission of HIV 10.Decrease in Deaths from the Leading Killer of Women Heart Disease 11.Birth Control Became Better, Safer, and More Accessible for Women 12.Cancer and Steroid Hormone Study Looked at Link Between Womens Cancers and Birth Control Pills 13.Approval of Emergency Contraception 14.Decrease in Teen Pregnancy 15.Efforts to Improve Pregnant Womens Health and Outcomes 16.Increase in Breastfeeding 17.Increase in Federal Funding to Address Violence Against Women 18.Improvements in Mental Health Care for Women 19.Improvements in Support to Family Caregivers 20.Improvements in Older Womens Health. 21.Largest Womens Health Prevention Study Ever Womens Health Initiative 22.Building Better Osteoporosis Treatments 23.Dangerous Drugs and Devices for Women Removed from Market 24.FDA Helps Women and Families Meet Their Nutritional Needs 25.Policies for Inclusion of Women in Clinical Trials 26.Addressing Sex Differences in Health 27.Addressing Minority Womens Health 28.Recognizing the Needs of Lesbian, Bisexual, and Transgender Women 29.Creation of HHS Offices of Womens Health 30.Creation of Womens Health Information Resources womenshealth.gov/about-us/government-in-action/achievements/

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HHS Office on Womens Health Vision All women and girls achieve the best possible health Mission The Office on Womens Health provides national leadership and coordination to improve the health of women and girls through policy, education, and model programs.

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Goals Educate health professionals Support model programs Inform and advance policies Educate the public

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youtube.com/WomensHealthGov pinterest.com/womenshealth twitter.com/womenshealth twitter.com/SaludDLaMujer twitter.com/girlshealth facebook.com/HHSOWH facebook.com/girlshealth Connect with OWH

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Challenges for the Future Understanding the complex nature of health disparities in multiple populations Improve maternal health during pregnancy Decrease unplanned pregnancy rate Find a solution for obesity in American women Eliminate violence against women

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Improving the Health of Women Through Research Janine Austin Clayton, M.D. NIH Associate Director for Research on Womens Health Director, Office of Research on Womens Health Public Health Reports Meet the Author! Live Webcast

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NIH Office of Research on Womens Health 25 th anniversary in 2015: Founded in 1990 1991: Womens Health Initiative 1993: NIH mandate to include women and minority groups in clinical research 2015: NIH focal point for research on sex/gender influences on health Benefits girls, women, boys, men XX XY

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This report does not focus strictly on the diseases and problems unique to women in the traditional sense that is, reproductive problems but rather is devoted to assessing the problems of womens health, in the context of the lives women in America lead today. Edward N. Brandt Jr., MD, PhD Assistant Secretary for Health Public Health Rep. 1985 Jan-Feb;100(1):73-106.

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Turning Discovery into Health Basic Research on Human Health and Disease Translational Research and Clinical Studies Funding for Training and Biomedical Workforce Development NIH funds 4,000 institutions, small businesses > 300,000 scientists and research personnel Partnership with universities, public, industry

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Womens Health Initiatives $250 million clinical trial $37 billion net economic return in the past decade Spared 75,000 women from heart disease Prevented 126,000 women from getting breast cancer Added 145,000 quality-adjusted life years overall Return on Investment

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ORWH A to Z Guide: Sex and Gender Influences on Health

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Sex is Not the Same as Gender Gender: behavioral, environmental, social, cultural Sex begins in utero.Gender also affects behavior and perception. Every cell has a sex. XX XY Sex affects behavior and perception. XX XY Sex: genetic, molecular, cellular, physiological XY XX feminine, masculine female, male

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NIH in 2015: Beyond Inclusion Sex/Gender Influences on Health and Disease BasicHealthy Women, Men, Girls, Boys Clinical

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May 14, 2014 Clayton JA, Collins FS. Nature. 2014 May 15;509(7500):282-3.

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Basic Research on Human Health and Disease Translational Research and Clinical Studies Funding for Training and Biomedical Workforce Development Sex is a Biological Variable Study Both Sexes

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Scientific progress emerging in NIH-funded laboratories Congressional interest and support Journal policies (November 2014) to improve reporting standards (including information about sex) NIH policy for considering sex as a biological variable in preclinical research Resources for the scientific community Enhancing Study of Male and Female Biology in Preclinical Research: It Takes a Village

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Better With Both: Encouraging Scientists to Study Both Sexes

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Better with Both: Improving Understanding of Female and Male Biology Across Diseases

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*CME or CPE credit can be awarded to eligible candidates who successfully complete Courses 1, 2, or 3 The Basic Science and the Biological Basis for Sex and Gender-Related Differences Sex and Gender Differences in Health and Behavior New! The Influence of Sex & Gender on Disease Treatment https://sexandgendercourse.od.nih.gov/ Sexual Dimorphism in Metabolic Bone Disorders Cardiovascular Disease in Women: A Focus on Heart Failure Sex and Gender Differences in Pulmonary Function and Health The Neural Basis of Sex Differences in Pain Sex Differences in Substance Abuse and Treatment Module 3. The Influence of Sex and Gender on Disease Expression and Treatment

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www.nih.gov/sexinscience

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Characterize Analyze sex-based data The 4 Cs of Studying Sex to Strengthen Science Collect Tabulate sex-based data Consider Design studies that take sex into account, or explain why it isnt incorporated Communicate Report and publish sex-based data

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Resources For more information, please visit http://orwh.od.nih.gov/ http://orwh.od.nih.gov/

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FDAs Role in Womens Health Marsha Henderson, MCRP Assistant Commissioner for Womens Health Food and Drug Administration Public Health Reports Meet the Author! Live Webcast

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What FDA Regulates

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Drug and Device Development Process

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FDAs Role in Clinical Trials FDA does not conduct or support clinical trials. FDA reviews clinical trials data submitted as a part of product applications. Diversity in clinical trial participation is essential. Office of Womens Health 33

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Why does FDA have an OWH? The 1992 GAO report said: women were not adequately included in clinical studies lack of understanding of sex/gender differences Response to Report: Womens Health Advocates lobbied Congress In 1993 Congress mandated that FDA establish an OWH

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GAO Report

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OWH-Funded Research 1994-2014 Office of Womens Health 37

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Womens Health Research Roadmap

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FDASIA Section 907 Data Report http://go.usa.gov/3DYEY & Action Plan http://go.usa.gov/3DY7w

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Trainings for Health Professionals Science of Sex and Gender in Human Health Online course series developed with NIH ORWH http://sexandgendercourse.od.nih.gov/ Womens Health Curriculum & Toolkit for Schools of Pharmacy Developed with AACP http://www.aacp.org/resources/education/whc

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Take Time to Care Outreach Program Reached over 50 million women Partnerships with government, national organizations, business, faith- based groups Consumer Publications

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Special Projects & Populations Pregnancy College Womens Campaign Women with Disabilities Project Pink Ribbon Sunday Mammography Awareness Program Video Outreach

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FDA Website www.fda.gov/womens

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What You Can Do Join the Conversation on Diversity in Clinical Trials Encourage Diverse Women to Participate Project with NIH ORWH and other stakeholders will target patients, researchers, and clinicians Spread the Word about FDA resources Incorporate materials into existing programs

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FDA For Women Website: www.fda.gov/womens FDA Womens Health Research: www.fda.gov/womenshealthresearch www.fda.gov/womenshealthresearch FDA Health Professionals Website www.fda.gov/ForHealthProfessionals/default.htm Resources

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Questions?

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Certified in Public Health (CPH) Continuing Education Credit Participation in this webinar qualifies for 1 CPHCE Credit For more information please visit: http://www.nbphe.orghttp://www.nbphe.org Password for credit is: Progress

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Thank you for participating. For more information about PHR, visit at: www.publichealthreports.org This Webinar will be archived for future reference at http://www.publichealthreports.org/webinars.cfm