Objectives. Future Population Growth Requires a Resurgence in Contraception. Overpopulation is Drowning the Earth. Projected World Population

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1 Future Population Growth Requires a Resurgence in Contraception David F. Archer, MD Professor of Obstetrics and Gynecology Director Clinical Research Center Department of Obstetrics and Gynecology Eastern Virginia Medical School Norfolk, Virginia, USA Objectives Describe the Growth in Population Identify Funding sources and Current Female Targets Address Development and Regulatory Issues Societal Problems Associated with Over Population Conclusion Overpopulation is Drowning the Earth Projected World Population Source: UN. World Population Prospects: The 2006 Revision Amsterdam Tokyo, Japan 1

2 Nanjing Road, China Current Needs For Contraception Funding for Research Reinvigoration of Pharmaceutical interest New Contraceptives for consumer Women Empowered to Decide on Use or Not Use Funding for Research in Contraception Bill and Melinda Gates Foundation Eunice Kennedy Shriver National Institute of Child Health and Human Development United States Agency for International Development World Health Organization Pharmaceutical Industry Family Planning Services 350 million Couples 1/3 of All Reproductive Age Lack Access to Knowledge of Full Range of Family Planning Services Expected to Increase by 40% in Next 15 Years Guillebaud, J. Youthquake Contraception Unmet Need Melinda Gates US $ 4.0 Billion Fund Raising Campaign Beginning July 2012 Goal 120 Million More Women Access to Contraception by 2020¹ Expectation Satisfying Global Unmet Need will Reduce Maternal Deaths by 30%² Current use of Contraception averted 38 deaths/100,00 women using contraception Pharmaceutical Industry Since the 1960 Introduction of oral hormonal methods Reduced Dose of Estrogen and Progestin Synthesized new Progestins Extended the Days of active hormone use Increased hormone(s) during the Cycle Altered the route of delivery Have Not Developed New or Different Methods 1. CBS News 12 July Ahmed, S Lancet 2012;380: 111 2

3 Development of Hormonal Contraceptives Clinical Contraceptive Research Biochemistry Synthesis of orally Active Progestins Pharmacology Role of Estrogens and Progestins in Reproductive Tissues Physiology Inhibition of normal process in Reproduction such as ovulation Independent Basic Researcher Small Biotech Companies Limited Funding Available Combination Oral Contraceptive Current Unique Targets for Female Contraception GDF-9 in Oocytes necessary for Cumulus Expansion and Oocyte Maturation¹ GPR 149 an oocyte enriched gene promotes maturation and fertility² CD9 is essential for sperm-egg fusion³ 1.Su, Y Q Mol Endocrinol 2010; 24: Edson, MA Endocrinology 2010;151: Glazar, AI Reproduct Fert Dev 2009;21: He, ZY Mol Reprod Dev 2009;76:629 Regulatory Agency Evaluates Preclinical and Clinical studies Develops Guidelines for Efficacy and Safety Approved New Products after Review Contraceptive Efficacy of a Product with a Pearl Index of >3.0 is effective New Methods may be 80% Effective and have Different Safety Profiles Contraceptive Efficacy Acceptance by Consumer Product and Mechanism of Action Compliance with Product Contraception: Use of agents, devices, methods, or procedures which diminish the likelihood of or prevent conception 3

4 Contraception: Use of agents, devices, methods, or procedures which diminish the likelihood of or prevent conception. Contraception: Use of agents, devices, methods, or procedures which diminish the likelihood of or prevent conception. The consumer needs to be aware of available options The consumer must be willing to use a method Contraception: Use of agents, devices, methods, or procedures which diminish the likelihood of or prevent conception. The consumer must use the method appropriately and consistently Contraceptive Efficacy Consumer Compliance with Method Clinical Oral Contraceptive Trial 17% of participants not using method based on serum hormone levels¹ Transdermal contraceptive Delivery System 22% of New Users and 7% of Experienced Users non compliant based on Serum Hormone levels² 1. Westhoff, C Contraception 2010;85: Kaunitz, AM ESCRH 2013 Poster 076 Thomas Robert Malthus The power of population is indefinitely greater than the power in the earth to produce subsistence for man. Population, when unchecked, increases in a geometrical ratio. Subsistence increases only in an arithmetical ratio REV THOMAS ROBERT MALTHUS Born: February 13, 1766 Died: December 23, 1834 (age 68) 4

5 Thomas Robert Malthus Mathematician and Fellow of Jesus College, Cambridge Published, anonymously, Essay on the Principle of Population in 1798 Results of Overpopulation Malthus Wars Infanticide Plague Famine Global HIV Prevent Sexual Transmission of HIV Develop Compounds that prevent the Sexual Transmission of HIV Target Female Controlled Methods Initiate and Produce Dual Methods to Prevent HIV and Pregnancy Results of Population Shifts Demographic Imbalance of Power can Aid in Winning in Warfare Rapid Population Growth Can Cause Unrest and Civil War Population Decline Results in Loss in War July 18, 2009: Over 50% of humanity is under 25 years old (UNFPA) Over 50% of unemployed humanity is under 30 years old and seeking work (UNFPA) Of 2+ billion youth, 50% will never be employed in their lifetimes (Andrew Zolli) Turchin P. War and Peace and War: The life cycles of Imperial Nations 2006 Pi Press darwinian-survival-why-young-people-want-to-change-the-world/ 5

6 Youth Bulge Rates of Youths age Greater than 28% of population 15 years or older United States Unemployment Rate Country Youth Bulge Fertility Rate Afghanistan Cent African Rep Iran Iraq Pakistan Thayer BL. Phil Trans R Soc B 2009;364:3081 European Youth Unemployment Rates Youth Unemployment Rate%: Euro area 23 Greece 58 Italy 37 Portugal 38 Spain 55 United Kingdom 21 Family planning could bring more benefits to more people at less cost than any other single 'technology' now available to the human race (UNICEF 1992) Future Contraceptive Options Contraceptive methods that inherently include other health or personal benefits that would increase their uptake and desirability. Novel non-hormonal methods as an alternative to hormonal formulations Conclusions Family Planning Services and Contraceptives Can Improve the World Reduction in The Birth Rate and Child Spacing Have Significant Impact for Society Innovation in Contraception is Needed for the Future 6