HUMANAE VITAE AND THE TRANSFORMATION OF WOMEN S HEALTH CARE

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1 HUMANAE VITAE AND THE TRANSFORMATION OF WOMEN S HEALTH CARE Stephen J. Hilgers, MD, JD, CFCMC, Dip. ABOG Advancing Humane Vitae St. Louis, Missouri October 12, 2018

2 Faculty Disclosure Stephen J. Hilgers, MD, JD, CFCMC, Dip. ABOG I have no relevant financial relationship to disclose

3 The Cultural Shift in Women s Health Care

4 Cultural Shift o FDA approves the use of the birth control pill to regular menstruation o ,000 women using the pill to regulate their cycles, while also utilizing the pill s contraceptive side effect o FDA approves the sale of the first oral contraceptive o of 4 American, married women under 45 using the pill o million women using the pill o million women using the pill o million women using the pill

5 Cultural Shift o Until 1930, all Protestant denominations, and the major Protestant Reformers, agreed with the Catholic Church s teaching condemning contraception o The Anglican church: 1930 (Lambreth Conference) announced that contraception would be allowed in limited circumstances 1958 (Lambreth Conference) approved contraception in all circumstances o Since then, ALL other Protestant denominations have followed in their acceptance of contraception o Today, the Catholic Church ALONE proclaims the historic Christian position on contraception

6 The Church s Response Pope Paul VI Humanae Vitae (July 25, 1968) Saint John Paul the Great o Theology of the Body Series of 129 lectures, Wednesday Audiences, St. Peter s Basilica, 9/5/79 11/24/84. o Love & Responsibility Originally published 1960 Writings by Karol Wojtyla prior to becoming Pope John Paul II

7 The Church s Response Humanae Vitae (Unlawful Birth Control Methods): o Therefore we base our words on the first principles of a human and Christian doctrine of marriage when we are obliged once more to declare that the direct interruption of the generative process already begun, and above all, all direct abortion, even for therapeutic reasons, are to be absolutely excluded... o Equally to be condemned... is direct sterilization, whether or the man or the woman, whether permanent or temporary. o Similarly excluded is any action which either before, at the moment of, or after sexual intercourse, is specifically intended to prevent procreation whether as an end or as a means.

8 The Church s Response Love & Responsibility: o God is CREATOR! o Within the vocation of marriage, God allows man and woman to be partners with Him in this process o Marriage is to be monogamous o A durable institution, which justifies the sexual act, and its primary purpose of procreation

9 The Church s Response Love & Responsibility: o Openness to life within the sexual act (possible parenthood) eliminates reciprocal egoism/objectification/exploitation of the other person o Honoring the natural, procreative order results in paying justice to our Creator o And results in true love between the married couple o Finally, human love loses nothing with periodic abstinence, in fact, the personal union becomes deeper by affirming the other s value

10 The Church s Response Theology of the Body: o Understanding the natural methods for the regulation of human fertility challenges us to: RESPECT the bodies of the spouses ENCOURAGE tenderness between spouses FAVOR the education of an authentic freedom APPRECIATE the innate language that expresses the total reciprocal self-giving of husband and wife

11 The Church s Response Theology of the Body: o Contraception: Objectively CONTRADICTORY language (not giving one s self totally to the other) Leads to a POSITIVE REFUSAL to be open to life FALSIFICATION of the inner truth of conjugal love

12 The Church s Call Humanae Vitae (Pastoral Directives): o Call to Men of Science, Doctors and Medical Personnel o Provide a secure basis for the regulation of birth, founded on the observation of natural rhythms o And obtain the knowledge needed to give married persons who consult with them wise counsel, and healthy direction [in this area] such as they have the right to expect

13 The Cultural Shift and the Current Status of Women s Health

14 Cultural Shift o The introduction of hormonal contraception has led to the nearly universal acceptance - by both the medical profession and society - as the first-line treatment available to women for the vast majority of gynecologic dysfunction.

15 Culture Shift in Women s Health Care Current Women s Health Care Treatments are: o Objectively CONTRADICTORY to the female reproductive system often acting to suppress the system and its related dysfunction as a means of treatment o Leads to a POSITIVE REFUSAL of the female reproductive cycle in its natural state o A FALSIFICATION of female reproductive health by suppressing the natural cycle with an artificial replacement

16 The Church s Response to Women s Health

17 The Church s Answer Formed in direct response to Pope Paul VI s Call to Medical Professionals in Humane Vitae: Pope Paul VI Institute Medical and Surgical NaproTechnology Creighton Model FertilityCare System Saint John Paul the Great Society of Procreative Surgeons

18 Creighton Model FertilityCare System (CrMS)

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22 Creighton Model FertilityCare System - Scope FertilityCare Centers U.S., Canada, Africa, Europe, and Latin America Certified Teachers, Certified Medical Consultants, Certified Nurse Practitioners Standardized, Allied-Health Education Programs Fellowship Program in Medical & Surgical NaProTechnology National and International Academic Accreditation o American Academy of FertilityCare Professionals (AAFCP)

23 Creighton Model FertilityCare System The fertility cycle in practical application has been largely ignored by the scientific community in both practical application, and scientific inquiry But, through the careful, scientific evaluation of the cycle using objective, standardized biomarkers, as set forth by the Creighton Model FertilityCare System - by the Pope Paul VI Institute in Omaha, Nebraska - in direct response to the Papal Call set forth in Humanae Vitae - great scientific advancements in women s health have been achieved Medical advances that are: o o o o o o o Medically safe Proven reliable Standardized Comparatively inexpensive Natural and cooperative A shared system Treatments that respect the dignity of women, marriage, and the reproductive cycle

24 Medical & Surgical NaProTechnology

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26 The Church s Response Women s Health Transformed

27 FAMILY PLANNING

28 Why it Matters?

29 Family Planning ALL couples should be able to plan their family both safely and effectively An effective family planning system, in the TRUEST sense, should provide couples with the means to both AVOID pregnancy and ACHIEVE pregnancy

30 Mainstream Treatment Strategies

31 Treatment Strategies ALL mainstream family planning methods are designed to do one thing AVOID Pregnancy Barrier methods (condoms) Oral contraceptives IUD Tubal Sterilization Vasectomy Hormonal implants/injections Vaginal hormonal ring Abortion ACCORDINGLY, they are not truly family planning systems, but pregnancy avoidance systems

32 Church s Response - Treatment Strategies

33 Creighton Model FertilityCare System ONLY system of family planning tailored to both achieve and avoid pregnancy ALL other systems are designed to prevent or abort an early pregnancy for family planning purposes 1,876 couples studied using system (Journal of Reproductive Medicine, 1998) o Method and use effectiveness for avoiding pregnancy 99.5% and 96.8% by 12 ordinal month; and 99.5% and 96.4% at the 18 th ordinal month

34 CrMS Effectiveness

35 Achieving Pregnancy The fertile window is best defined as the 6 day interval ending on the day of ovulation During this time, the viability of both the egg and sperm should be maximal For couples trying to achieve pregnancy, it is imperative that they are able to confidently identify, and use, via fertility-focused intercourse, their fertile window Studies have shown that when the fertile window is used accurately, and consistently, the time to pregnancy is decreased significantly

36 Achieving Pregnancy Sperm can survive for up to 6 days in properly estrogenized cervical mucous The highest probability of clinically evident conception occurs with intercourse 1 to 2 days before ovulation

37 Achieving Pregnancy How long does it take for a couple to become pregnant? Time of Exposure % Pregnant 3 months 57% 6 months 72% 1 year 85% 2 years 93%

38 Achieving Pregnancy How long does it take for a couple to become pregnant, with timed intercourse (fertilityawareness) (n=100)? Time of Exposure % Pregnant 1 month 76% 7 months 100%

39 Creighton Model FertilityCare System Studies have shown that a cervical mucus fertility awareness method (like the CrMS) of identifying a couple s fertile window performs as well as or better than basal body temperature and LH monitoring, and this system can be used effectively by couples experiencing long and/or irregular cycles along with couples suffering from PCOS. A recent study evaluating the top 53 smartphone fertility-focused apps revealed that they are generally inaccurate with only 3 apps and 1 website correctly identifying the fertile window. There is evidence to suggest that LH urinary detection kits underestimate the fertile window, and that ovulation can occur up to 2 days after a positive LH reading. In addition, false positive results (falsely predicting ovulation when it has not occurred) occurs in approximately 7% of cycles Lastly, urinary LH strips cannot be used by couples experiencing long and irregular cycles, and/or PCOS.

40 The Church s Response to Women s Health has Resulted In... A COMPLETE family planning system that is SAFE and EFFECTIVE in both AVOIDING and ACHIEVING PREGNANCY Modern family planning system are simply pregnancy avoidance methods Modern methods of instructing patient s on their fertility window are fraught with high rates of inaccurate readings, false positive results, and are wholly incapable of assisting couples who experience long, and irregular cycles

41 Premenstrual Syndrome (PMS)

42 Why it Matters?

43 Premenstrual Syndrome Premenstrual Syndrome (PMS) The cyclic occurrence of symptoms that are of sufficient severity to interfere with some aspects of life that appear with consistent and predicable relationship to the menses

44 Premenstrual Syndrome Prevalence: 75% of women experience some recurrent PMS symptoms 20-40% are mentally or physically incapacitated to some degree 5% experience severe distress Highest incidence occurs in women in their late 20s to early 30s

45 Premenstrual Syndrome Moderate to Severe PMS symptoms have been linked to: Reductions in health-related quality of life Decrease in work productivity Increase in work absenteeism Increase in visits to ambulatory healthcare providers Premenstrual Dysphoric Disorder (PMDD) Women with PMDD, according to research, may have an elevated risk of suicidal ideation and suicidal attempts

46 Mainstream Treatment Strategies

47 Treatment Strategies Psychiatric Interventions: Selective Serotonin Reuptake Inhibitor (SSRI) (Fluoxetine and Sertraline) Large trials show benefit Anxiolytics (Alpraxolam and Buspirone) Studies show efficacy in PMDD Dependency is a very real concern Studies show no better than placebo

48 Treatment Strategies Hormonal Interventions: Act by SUPRESSING the normal menstrual cycle in order to abolish cyclic changes in hormones Oral Contraceptives Artificial hormones act to suppress ovulation Drospirenone-containg pill Approved by FDA for PMDD; effectiveness after 3 cycles is unknown GnRH agonists Medical Menopause, or Medical Oophorectomy Very difficult to be on long-term (osteoporosis risk (bone loss)), hot flashes, unless add back estrogen/progesterone therapy used)

49 Treatment Strategies Surgical Interventions: Bilateral oophorectomy has been suggested as a definitive surgical treatment option

50 Treatment Strategies Drospirenone-Containing Oral Contraceptive Risks: 2009 Study linked drospirenone-containing oral contraceptives to a higher risk of blood clot formation 2012 FDA Drug Safety Communication Drospirenone- Containing Oral Contraceptives may result in as much as a three-fold higher risk of blood clot formation that other progestin-containing oral contraceptives Rational for use Risk is still lower than risk of blood clots associated with pregnancy or the postpartum period Since 2000, nearly 12,000 Lawsuits have been filed by women claiming they suffered injuries related to blood clots that formed after starting drospirenone-containing oral contraceptives

51 Treatment Strategies Summary of Mainstream Treatment Strategies: Treat a gynecologic disease process with psychiatric medications Complete suppression of the gynecologic system Surgical castration (oophorectomy) Why hasn t natural hormonal support been advocated? Reliance on suppressive therapies dominate gynecologic thought Absence of reproducible method of evaluating individual cycles Natural hormonal studies miss the mark by focusing on the day of the menstrual cycle (methodologically flawed) Studies design is extremely important! Studies that are based on starting progesterone supplementation on a certain day show no benefit But, when given TIMED during ovulation a benefit is clearly measured

52 Church s Response - Treatment Strategies

53 Medical NaProTechnology PMS Evaluation and Treatment

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60 NaProTechnology Case Examples

61 Case Example - PMS 43 year old female presented for NaPro Consultation Patient presented with the following symptoms prior to the onset of her cycle: o o o o o o o o o o o o o o Irritability Anger Depression Hopelessness Mood swings Breast tenderness Bloating Weight gain Carbohydrate cravings Teariness Headaches Fatigue Concentration issues Feeling overwhelmed

62 Case Example - PMS Symptoms start approximately 7-10 days before the onset of her cycle; she feels like she crashes Patient was tired of being told she needed an antidepressant or birth control pills Timed menstrual cycle hormone evaluation was performed

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65 Case Example - PMS Patient was diagnosed with a Hormonal Deficiency She was started timed, post-ovulatory hormonal support taken in a cooperative manner with the patient s cycle and not in a suppressive manner Patient presented the following cycle for interval follow-up reporting MARKED improvement in PMS symptoms Patient was seen for long-term follow-up and continues to report marked resolution of her symptoms

66 The Church s Response to Women s Health has Resulted In... The scientific ability to ACCURATELY evaluate the cyclical hormones of the menstrual cycle The scientific ability to DIAGNOSE various types of hormone dysfunction within the cycle s natural state The natural, cooperative TREATMENTS necessary to HEAL hormonal dysfunction WITHOUT SUPPRESSING the reproductive system

67 Polycystic Ovarian Syndrome (PCOS) & Irregular Cycles

68 Why it Matters?

69 PCOS The most common endocrine disorder in women of reproductive age and is thought to affect 5-10% percent of all U.S. women PCOS: 2 out of 3 of the following: o Oligo and/or Anovulation o Clinical and/or biochemical signs of hyperandrogenism o Polycystic Ovaries (by ultrasound) Hallmark of PCOS is: o Polycystic ovaries that are resistant to the hormonal stimulus for ovulation resulting in highly irregular ovulatory patterns and, accordingly, highly irregular cycles o Insulin receptor dysfunction at the cellular level resulting in hyperinsulinemia and further hormonal and ovulatory dysfunction including elevation in androgen levels and unwanted side effects (abnormal hair growth, male-pattern acne, etc.)

70 PCOS Dyslipidemia Diabetes mellitus o 40% develop Type 2 Diabetes by age 40 Gestational diabetes Hypertension and Hypertensive Disorders in Pregnancy Cardiovascular disease o 7 times increased risk of cardiovascular disease and heart attack Thrombosis Endometrial cancer o Endometrial hyperplasia occurs in 35 % of women with PCOS o PCOS is a know risk factors for endometrial cancer Breast cancer o 3-fold increase in postmenopausal breast cancer and PCOS Ovarian cancer o Research shows possible association

71 PCOS Infertility Miscarriage o Miscarriage rates reported to be between 30 to 50% of all conceptions with PCOS nearly 3 TIMES higher risk of miscarriage o 30% of women with recurrent miscarriages have PCOS Endometriosis o Approximately 50% association with PCOS Ovulatory Dysfunction o 61% of studied ovulation events dysfunctional Chronic Fatigue Syndrome Hirsutism & Acne Dysfunctional Uterine Bleeding o More frequently associated with hysterectomy

72 PCOS Depression and Anxiety o Studies have shown that women with PCOS are at a significantly higher risk of depression compared with non- PCOS women o Prevalence of depressive disorders among women with PCOS found to be approximately 64% o PCOS is also associated with higher levels of anxiety and depression

73 Mainstream Treatment Strategies

74 Treatment Strategies Menstrual Cycle Suppression: Birth Control Pills, Intrauterine Device, Cyclic Progestin: o Suppression of ovulation results in the suppression ovarian androgen production o Provides endometrial protection o Abnormal bleeding patterns 59-89%

75 Church s Response - Treatment Strategies

76 Medical NaProTechnology Polycystic Ovarian Syndrome

77 CrMS Regular Cycle

78 PCOS

79 Medical NaPro - PCOS PCOS unopposed estrogen stimulation Women with long and irregular cycles can be regulated with IMH Progesterone in a regular fashion to provide opposition to estrogen stimulation Given long-term, so long as the menstrual cycle remains long and irregular Patient are also started on natural supplements that have been show to reverse the negative impacts of PCOS: o Myo-Inositol o Vitamin D (if deficient) o Alpha Lipoic Acid o COQ10

80 Medical NaPro - PCOS Not unusual for ovulation to occur on a more regular basis once progesterone is given in this fashion Once ovulation begins to occur, IMH progesterone is then started during the post-ovulatory window Evidence of resumption of normal ovulatory patterns can be clearly seen on a woman s CrMS chart

81 NaProTechnology Case Examples

82 Case Example - PCOS Patient presented with PMDD, dysmenorrhea, PCOS, oligomenorrhea, and bipolar disorder on multiple psychiatric medications At time of initial visit, patient stated I know my symptoms are related to my hormones CrMS charting revealed: o Abnormal bleeding patterns o Long, irregular cycles often more than 60 days in duration o Variable ovulatory patterns o Short, and irregular post-ovulatory cycle length

83 Case Example - PCOS First step, medical management to regulate her cycles: o Patient was started on insulin regulating supplements (Myo- Inositol) o She was also started on timed, cyclical progesterone support to naturally begin regulating her cycle o She was also started on natural ovarian support supplementation and educated on natural ovarian support (dietary/environmental)

84 Case Example - PCOS Following treatment the patient s chart revealed: o Improvement in cyclic regularity o Abnormal bleeding patterns normalized regular length menses with resolution of intermenstrual bleeding pattern o Ovulatory patterns normalized Now, having achieved cycle regularity along with a regular ovulatory pattern, a Hormone Series could be performed

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89 Case Example - PCOS Hormone Series Hormone defifiency diagnosed Patient started on post-ovulatory hormone treatment Patient reported marked improvement of her PMDD & bipolar symptoms Since the initiation of NaPro treatment the patient has now stopped all psychiatric medications (except one) with assistance of psychiatry And she continue to have cycle regularity to the point she no longer requires progesterone to initiate her monthly cycles

90 The Church s Response to Women s Health has Resulted In... TREATMENTS tailored-made for women with irregular cycles, and those suffering from conditions such as Polycystic Ovarian Syndrome without requiring treatments designed to suppress the natural menstrual cycle Modern treatment strategies are SUPPRESSIVE in nature. Often causing patients to believe their gynecologic issue is cured. This provides women with a false sense of security - when in actuality their underlying gynecologic dysfunction remains.

91 Infertility

92 Why it Matters?

93 Infertility Definition: one year of unprotected coitus without conception 10-15% of couples of reproductive age 1 in 6 women of reproductive age report they have sought professional help during their lifetime for infertility Sharp increase in demand for infertility services starting in 1980

94 1790 Birth rate was 55 per 1000 Infertility 1990 Birth rate was 15.5 per 1000 o A decrease from 8 to 1.2 per woman Why the decline in U.S. Fertility? o Changing roles/aspirations for women o Postponement of marriage o Postponement of pregnancy with marriage (83% of the decline of total fertility rate due to this factor) o Increasing use of contraception o Liberalized abortion o Concern over the environment o Unfavorable economic conditions

95 Infertility Causes of infertility: o Couple - Male factor 23 percent Ovulatory dysfunction 18 percent Tubal damage 14 percent Endometriosis 9 percent Coital problems 5 percent Cervical factor 3 percent Unexplained 28 percent

96 Mainstream Treatment Strategies

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105 Church s Response - Treatment Strategies

106 Medical NaProTechnology New Hope in the Evaluation and Treatment of Infertility

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119 Surgical NaProTechnology (Procreative Surgery) Specialized form of gynecologic surgery Procreative in nature Primary aim is to reconstruct the uterus, tubes, and ovaries Able to provide near adhesion-free surgery with strong focus on adhesion prevention measures Requires commitment to excellence, attention to detail, patience, and a desire to provide surgical procedures without major postoperative adhesion formation Current emphasis Minimally invasive restorative techniques (operative laparoscopy and robot-assisted) with adhesion prevention measures and tissue repair

120 Surgical NaProTechnology (Procreative Surgery) PPVI Institute for the Study of Human Reproduction (National and International referral center), in affiliation with Creighton University School of Medicine in Omaha, Nebraska Surgical Fellowship Training involving o Extensive da Vinci robotic experience o Training in the use of operative laser (Omni-Guide CO2) o Training in surgical techniques designed to prevent adhesions o Training in the diagnosis of, and surgical management of endometriosis and pelvic adhesions o Training in various microsurgical techniques Fimbrioplasy Tubal Reanastamosis Pelvic adhesive disease Endometriosis Ovarian cysts Polycystic ovaries Reproductive anomalies

121 The Church s Response to Women s Health has Resulted In... COOPERATIVE infertility treatments that work to CORRECT the underlying dysfunction resulting in LASTING INFERTILITY ASSISTANCE Modern treatments act largely by circumventing fertility within its natural context without achieving true infertility treatment

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123 Society of Procreative Surgeons

124 The Church s Call WISDOM IN THE CHURCH has resulted in WISDOM IN WOMEN S HEALTH MUCH WORK IS STILL NEEDED But, with a large and growing body of medical professional devoted to carrying forth the Pope s GREAT COMMISSION, women s health will continue to advance and improve in ways never before thought possible all for the benefit of women and couples around the world who desire real solutions to real medical problems

125 HUMANAE VITAE AND THE TRANSFORMATION OF WOMEN S HEALTH CARE Stephen J. Hilgers, MD, JD, CFCMC, Dip. ABOG Advancing Humane Vitae St. Louis, Missouri October 12,