The Science Behind Hormonal Contraceptives

The Science Behind Hormonal Contraceptives
Presented by Scott & Laura Schulze Pro-Life Symposium & Technology Symposium Saturday, September 19, 2009 Dayton Engineers Club Dayton, OH

Overview How the Body Naturally Works
History of Hormonal Contraceptives How Contraception Unnaturally works What does Planned Parenthood say about Hormonal Contraceptives Healthy Alternatives to Contraceptives

History of Hormonal Contraceptives How Contraception Unnaturally works Planned Parenthood & Hormonal Contraceptives Healthy Alternatives to Contraceptives

The Female Reproductive System

Follicle-Stimulating Hormone (FSH)
Endometrium Luteininzing Hormone (LH) Pituitary Gland Follicle-Stimulating Hormone (FSH) Ovaries Estrogen Cervix Ovulation Progesterone 5

How the Body Naturally Works
Three things necessary for Conception of baby (embryo) Sperm Egg Cervical Mucus Helps healthy sperm reach egg Implantation onto Uterine Wall is necessary for baby (embryo) to survive

History of Hormonal Contraceptives
1550 BC Egyptian Papyrus mentions the use of Crocodile Dung before intercourse Ancient Arabian documents mention the use of Elephant Dung mixed with Honey Incas, Myans, Aztecs used roots of plants like mandragora Also used in ancient times were: Seeds of Queen Anne’s Lace, Wild Carrot, Pennyroyal, Artemisia, Myrrh, Rue, Pomegranate Seeds

7th Century BC the Silphion Plant from Cyrene Silphion is a Giant Fennel plant Contraceptive & Abortifacient Only grew in a 125 mile x 30 mile stretch of Libya Over harvesting led to increase in value “worth its weight in silver” Extinct by 2nd Centruy AD Asafoetida (used in Worcestershire Sauce) Cheaper but less expensive alternative to Silphion

Silphion Plant from Cyrene on an ancient coin. The plant created a huge economic boost for Cyrene The usage of the Silphion is implied

1873 Congress passes Comstock Law – birth control illegal 1914 Eugenics advocate Margaret Sanger coins term “birth control” in her journal The Woman Rebel, flees country to avoid lawsuits 1918 The Crane Decision allows birth control for therapeutic purposes 1921 Margaret Sanger forms American Birth Control League (Planned Parenthood Federation of America)

1921 Haberlandt showed that transplantation of ovaries of pregnant rabbits into fertile female rabbits suppressed their ovulation and fertility 1944 The effective hormone was found to be progesterone 1936 Margaret Sanger orchestrates court battle which results in legitimizing birth control and official recognition by AMA 1938 Inhoffen & Hohlweg synthesized Ethinyl-Oestradiol

1941 Russel Marker makes Synthetic Progesterone with Mexican wild yams (cabeza de negro) 1951 Margaret Sanger has 200 birth control clinics 1951 Margaret Sanger asks Dr Greg Pincus to create a contraceptive pill 1951/1954 Carl Djerassi creates pill form of synthetic progesterone 1952 Frank Colton develops a pill form of synthetic progesterone 1953 Margaret Sanger secures funding for Dr Pincus to continue development of a contraceptive pill

1954 Dr Pincus & Dr John Rock begin first human trials of their pill (high dose) in Boston under guise of a “fertility study” due to anti-birth control laws in US The study uses 21 days of pill + 7 days off to allow for menstruation so the pill will seem “natural” 1955 Conclusive results of study announced 1956 Clinical testing of Enovid begin in San Juan, Peurto Rico due to anti-birth control laws in US. Pills made by G.D. Searle 3 Women died + 17% had side effects  but no action taken

1957 Enovid submitted to FDA for menstrual disorders (GD Searle) 1959 Dwight Eisenhower – Birth Control is “not our (govt.) business” 1960 Enovid submitted to FDA as a contraceptive (what is was actually developed for) First drug in history to be given to a healthy person for long-term use 1960 Enovid approved by FDA as a contraceptive

1961 Anovlar – First European oral contraceptive introduced 1962 G.D. Searle (Enovid) receives reports of dangerous side effects 11 Deaths, Blood Clots, Heart Attacks – no action taken Complaints dismisses as “exaggerated” Considered the “price women had to pay” for a contraceptive 1962 Ortho Novum hits US market. Other pills follow 1964 Lyndon B. Johnson pushes legislation for federal support of birth control for the poor

1965 Griswold v. Connecticut – US Supreme Court rules prohibition of birth control sales is violation of “right to privacy” 1967 NAACP accuses Planned Parenthood of racial genocide 1969 A Doctor’s Case Against the Pill (Barbara Seaman) published 1970 After Congressional hearings, information on side effects of the pill are included in the packaging 1972 Eisenstadt v. Baird – US Supreme Court rules against the prohibition of birth control sales to single women 1974 Govt. supports Birth Control clinics in 2,379 counties (77%) 1980’s Low dose birth control pills introduced. Original high dose pills removed from market

1990 FDA approved Norplant 2002 Norplant removed from US market 2002 FDA approved Norplant-2 1999 FDA approved Plan B (Emergency Contraception) 2000 FDA approved RU-486 (Abortion Pill) 2000 FDA approved Mirena 2001 FDA approved Nuva-Ring 2001 FDA approved Ortho Evra Patch 2004 FDA approved Depo-Provera 2007 FDA approved Lybrel

Birth Control Pills Three Kinds: “Mini-pill” – progestin only
Combination – progesterone and estrogen Seasonale – longer cycling The birth control pill is also known as an oral contraceptive. It is a pill taken by mouth daily. There are several types of birth control pills on the market, but they basically break down into two groups: The progestin-only “mini-pill” and the combination pills. The progestin-only mini-pill uses only one artificial hormone, called progestin, which is a steroid that has an effect similar to natural progesterone. The combination type contains two artificial steroids that mimic the effects of natural estrogen and natural progesterone. Some pills work in a “monophasic” way, keeping the dosage of hormones the same throughout the pill cycle. Others work in a biphasic or triphasic capacity which alters the dosage of artificial hormones tow or three times, respectively, through the cycle of pills, attempting to produce fluctuations similar to what a fertile woman would undergo naturally. The Seasonale is referred to as an “extended-cycle” birth control pill. The only difference between Seasonale and regular combination birth control pill is that Seasonale packets contain 91 pills, instead of 28. The effect is that the reproductive process is suppressed for three months instead of one. Used by 10 million women in the United States, 4 million are 25 years old and younger.

4- Pronged Attack on a Woman’s Fertility
1) Prevents ovulation from occurring. (Prevents release of egg from ovary.) 4) Lowers efficiency with which the fallopian tubes propel eggs from ovaries to uterus. When a woman ovulates, hormones released from the pituitary gland stimulates her ovaries to ripen and release an egg. The combination pill usually interrupts the release of these pituitary hormones resulting suppression of ovulation. Ovulation is not always suppressed, however. Ovulation occurs in 2% to 10% of cycles of women taking the pill. For example, if 60 million women worldwide are on the low-dose Pill, there would be 1.2 to 6 million ovulations per cycle. This is known as break-through ovulation, and it is even more frequent with the progestin-only pill because it has a weaker effect than the combination pill. The second way that the Pill works is by drying up the fertile mucus through which sperm swim to meet the egg. The mucus thickens under the influence of a progestin and so impedes sperm migration. In addition, the progestin component of the combination pill and the progestin-only mini-pill causes the inner lining of the uterus to become thin and shriveled. After an egg is fertilized, it normally implants in the endometrial lining to draw nourishment and sustenance. If the lining is thin and shriveled, it cannot support implantation of the embryo, thereby, causing a chemical abortion. ABORTIFACIENT It is estimated that for every year that a woman uses the pills, she has at least one early abortion during that year. One last factor in a woman’s fertility that may be affected by the Pill is the Fallopian Tubes. Progestins lower the efficiency with which the fallopian tubes propel eggs from the ovaries toward the uterus. This can cause the embryo not to reach the uterus in time to implant successfully, causing another early abortion. A woman’s natural fertility requires several systems and organs to coordinate smoothly. The synthetic chemicals in any type of birth control Pill interfere with this coordination, adversely affecting her normal fertility and any “accidental” conceptions. 3) Changes the lining of the uterus so that the tiny baby boy or girl cannot implant and grow. CHEMICAL ABORTION 2) Dries up mucus so that sperm can neither live in vaginal environment nor enter the cervix.

Common Side Effects of Birth Control Pills
Nausea and vomiting (in about 10% of users) Symptoms of PMS: fatigue, breast tenderness, irritability, difficulty concentrating, headaches/migraines, bloating/weight gain/water retention Mood swings, depression Weight loss Loss of sex drive Mid-cycle bleeding Dysmenorrhea (painful menstruation) Amenorrhea (absence of menstruation) Vaginitis and vaginal infections Temporary or permanent infertility when discontinuing Pill Some side effects are minor while some may be more sever and call for discontinuing the drug. The side effects listed have been experienced by women on the Pill. Over 30 known side effects of the Pills. More susceptible to HIV b/c the pill weakens the immune system Mental depression – even to the point of suicide and/or suicidal tendencies There can be mid-cycle bleeding in the first few months, especially in smokers and those who miss their daily dose. Some have reported changes in menstrual flow, and even loss of menstruation. For some, painful menstruation has been reported to worsen, even though many women take these hormones in an attempt to relieve the problem. Although some women are given the Pill for irregular cycles, it does nothing to improve the underlying problem causing the irregularity. Often the irregularity returns when the Pill is discontinued, sometimes more severely. More than a third of all women who start taking the Pill stop within three months because of the side effects — so know you're not alone if you've had problems while on the Pill.

Risks Associated with Birth Control Pills
Blood clots – MI, Stroke, Pulmonary Embolism, Renal Artery Thrombosis & Kidney Damage, Temporary/Permanent Blindness OCP use and obesity: DVT risk increased 10 fold Hispanic women with hx of GDM – thrombosis risk WHO Study: Migraines associated with increased risk of cerebral thromboembolism Smokers over age of 35 – heart disease, MI, stroke Mild elevation of blood pressure (hypertension) Cancer of the Breasts and Cervix NIH: Estrogen is a known human carcinogen. 2002 The Pill can have harmful effects on the circulatory system, just as smoking does. A woman who takes the Pill and smokes increases her risk of heart disease by 500%. Experiments have shown that synthetic estrogens and/or progestins cause women’s breast cells to divide more rapkidly, ehich makes them more easily affected by carcinogens. 18 out of 21 research studies done since 1980 on the connection between the pill and breast cancer showed that Pill users have a higher risk of breast cancer than non-users. An analysis in 1990 of the research up to that time showed that women who used the Pill for 4 or more years before their first full-term pregnancy had a 72% increased risk of developing breast cancer. Dr. Erik Odeblad – scientist – did extensive research on the cervix, specifically cervical mucus. He also did studies on effects of oral contraceptives on the cervix. He found that while pregnancy counteracts the normal ageing process and actually has a rejuvenating effect on the cervix so that the cervix of a 33-year-old woman becomes like that of a 20-year-old, the Pill, especially after long-term use has a reverse effect - the cervix of a 33-year-old woman on the Pill becomes like that of a 45-year-old and the cervical canal becomes much narrower.

Contraindication of Birth Control Pills
Cannot be used by those with a history of: Breast cancer Blood clots or risk to develop blood clots Liver disease Kidney disease Unexplained uterine bleeding Smokers over age 35, Melanoma (a type of skin cancer) Those on certain medications (e.g. antibiotics) The birth control pill increases the risk of breast cancer by over 40% if it is taken before a woman delivers her first baby.4 This risk increases by 70% if the Pill is used for four or more years before the woman’s first child is born. While pregnancy counteracts the normal ageing process and actually has a rejuvenating effect on the cervix so that the cervix of a 33-year-old woman becomes like that of a 20-year-old, the Pill, especially after long-term use has a reverse effect - the cervix of a 33-year-old woman on the Pill becomes like that of a 45-year-old and the cervical canal becomes much narrower. The new lower dosage gestagen Pills produce similar effects.

Ortho-Evra Square patch that slowly releases a combination of estrogen and progestin hormones through the skin. Worn for three weeks, off for one week Same mechanism of action, side effects and risks as the pill Can cause rash or skin irritation at site of patch Seems to be less effective than the Pill “The PATCH” Patch worn on upper arm, buttocks, abdomen or thigh Prevents ovulation, dries mucus, changes uterine lining (abortifacient) Nausea, Headache, Depression, Breast Tenderness, Irregular bleeding, abdominal pain, weight gain, irregular bleeding Increased Risks for Cardiovascular Disease, Venous Thromboembolism, Breast CA, Cervical CA Several Lawsuits for: Stroke, Pulmonary Embolism, Paralization, Blod Clot resulting in death

FDA’s Approval of the Ortho Evra Patch
Prior to the FDA approval of 'The Patch' in November 2001, an FDA medical reviewer took exception with the manufacturer's conclusions regarding two cases of blood clots in the lung affecting two, rather young participants in the Ortho Evra clinical trials. “(the reviewer) DOES NOT AGREE WITH THE SPONSOR'S [Ortho-McNeil] ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases in the … group.” Despite the warning, the FDA gave Ortho Evra approval. July 2005, an investigation by the Associated Press exposed that 17 of the 23 deaths associated with the use of the Ortho Evra birth control patch appeared to be related to the formation of blood clots. November 2005, four months after the Associated Press report, the FDA fostered a label change to the product, indicating the increased risk of blood clots, and representing double the risk of clots for women taking The Pill.

Nuva Ring Thin, transparent, flexible ring inserted into the vagina where it slowly releases estrogen and progestin hormones into the body. Left in for three weeks, out for one week Same mechanism of action, side effects and risks as the pill and patch Can cause vaginal irritation and discharge “The PATCH” Patch worn on upper arm, buttocks, abdomen or thigh Prevents ovulation, dries mucus, changes uterine lining (abortifacient) Nausea, Headache, Depression, Breast Tenderness, Irregular bleeding, abdominal pain, weight gain, irregular bleeding Increase risk of cervical and breast cancer

Depo-Provera Most widely-used contraceptive injection in the world that lasts three months. Reduced Bone Density Amenorrhea, Headaches, Weight Gain, Low Birth Weights Increased Risks for Breast Cancer and STD’s Delayed return in fertility (up to 18 months) Risk of Breast Cancer tripled if use the shot for at least 2 years before age of 25. Mechanism of Action Prevents pregnancy by inhibiting ovulation Abortifacient: alters normal growth of endometrium and prevents implantation of newly conceived baby Major disturbances of menstrual pattern. Prolonged and unpredictable delay in return to fertility Mild deterioration of carbohydrate tolerance Severe and prolonged bleeding Decrease in breast milk production Depression and reduction in libido Danger to fetus in event of pregnancy: mainly some masculinizing effects in females Loss of calcium from bones Significant weight gain Women who take the shot for 2 years or more before the age of 25 have at least a 190% increased risk of developing breast cancer. Excessive and/or irregular bleeding Temporary or permanent sterility Severe mental depression Depletes calcium storage, placing women at risk for osteoporosis at a much younger age. Worsens a woman’s cholesterol level

Birth Control Implants
Five or six silicone rods surgically inserted into arm, releasing hormones into the bloodstream and lasting for five years. Withdrawn from US market in 2002 Norplant A thin rod inserted under the skin of the upper arm, containing a synthetic hormone that is released into the body over three years. Same mechanism of action as Pill. Pain at insertion site, acne, increased BP, increased clots, irregular bleeding Same mechanism of action as the Pill, Patch, Ring, Depo Broken or Migrating Rods Weight Gain, Nausea, Depression, Infection, Ovarian Cysts, headache, migraines, breast tenderness Increased Risks for Breast Cancer, Liver Disease, Blood Clots Norplant Withdrawn from US in 2002 Over 50,000 women filed lawsuits against Wyeth in first 6 years

Emergency Contraception
Known as “the morning-after pill,” EC is a high dosage of the birth control pill. Plan B® is used to prevent pregnancy after an unprotected sexual encounter. It works by delaying ovulation and fertilization, and perhaps preventing implantation in the uterus. It does not terminate an established pregnancy. (According to the ACOG definition of pregnancy) The first tablet of Plan B® should be taken as soon as possible, within 72 hours (3 days) of unprotected sex. The second should be taken 12 hours later. The most common side effects of Plan B® include nausea, abdominal pain, fatigue, headache and menstrual bleeding Nausea and vomiting Breast tenderness Ectopic pregnancy Blood clot formation Progestin-only EC

RU-486 Mifepristone + Misoprotol
Referred to as “the abortion pill” but is actually a process of consuming multiple pills Man-made steroid designed to work against a woman’s normal, natural state during pregnancy. First visit – RU486 pills given to kill baby Second visit – Misoprostol pills/suppositories given in attempt to expel the dead baby Final visit – If RU486 failed, surgical abortion scheduled Side effects: nausea, abdominal pain, vomiting, heavy and extended bleeding, heart attack, hemorrhage, impaired future fertility Also called the abortion pill During pregnancy, the preborn baby requires a hormone called progesterone. This chemical is produced natually in the mother’s body. It is so valuable to the baby’s proper growth and development that some call progesterone “nature’s pregnancy hormone.” RU-486 works against progesterone by breaking down and then destroying the surroundings that the baby has established in the mother’s womb. It eventually destroys the baby as well by cutting off nourishment to the preborn child, who starves to death inside his mother’s womb.

FDA’s Approval of RU-486 FDA’s Approval of RU-486 (developed by the Population Council) The median total review time for new drug applications is 14.8 months FDA review time for RU-486 was 6 months. FDA quickly approved RU-486 on “fast track” process reserved for drugs used for life threatening diseases RU-486 Expedited Clinical Trials 3-8% Unsuccessful Pain, Nausea, Cramps, Bleeding, Vomiting 3% Required Blood Transfusions or Surgery Several Maternal Deaths linked to RU-486 A similar abortion drug was secretly tested in Philippines & Mexico as “tetanus” vaccine

Intra-Uterine Devices
A small, flexible, plastic t-shaped device that contains either copper or the hormone progesterone and is inserted into the uterus by a clinician to prevent pregnancy. The UID can be left in place for 1 to 10 years, depending on the type of IUD. The IUD is an object that is placed inside the uterus by a physician.

How It Works: Kills sperm before they reach the ovum, affecting cervical mucus Inhibits implantation IUD containing progesterone also can inhibit ovulation to some degree Although doctors claim they aren’t quite sure how the IUD works, it is clear that the IUD does not prevent ovulation, which means that the woman’s body will still produce an egg during her monthly cycle. When the IUD is put in place, it and the chemical it contains alters the fluids in the womb, and the lining of the womb. The presence of the IUD irritates the lining, preventing implantation.

Increased risk of miscarriage (spontaneous abortion) Ectopic (extrauterine) pregnancies 10 times above usual incidence Pelvic inflammation that can cause sterility Anemia due to excessive menstrual bleeding Embedding, migration of fragmentation of IUD Spotting or prolongation of menstrual flow Increased risk of infection Occasional perforation of uterus, cervix, or bladder requiring surgery Backache Copper toxicity – poisoning of the organs Localized pain that persists each time ovulation occurs

What does Planned Parenthood have to say about Oral Contraceptives?
Quotes from Margaret Sanger, Eugenics Promoter & founder of Planned Parenthood: “More children from the fit, less from the unfit – that is the chief aim of birth control” – Birth Control Review, May 1919 “The most merciful thing that a large family does to one of its infant members is to kill it” Women and the New Race, 1920 “(The purpose in promoting birth control) ‘to create a race of thoroughbreds’” Birth Control Review, November 1921 “Couples should be required to submit applications to have a child” Birth Control Review, April 1932

“(pregnancy is) an episodic, moderately extended chronic condition… may be defined as an illness…treated by evacuation of the uterine contents…” Dr. Warren Hern, “Is Pregnancy Really Normal?” Family Planning Perspective, Planned Parenthood vol 3, no 1, Jan 1971, pg1. “If your parents are stupid enough to deny you access to birth control, and you are under 18, you can get it on your own. Call Planned Parenthood” Ad in Dallas Observer, Jan 30, 1986 “No. You do not need your parents’ permission to get birth control at Planned Parenthood, and we will not tell your parents that we have seen you. At Planned Parenthood all of our services are confidential (for) teens age 12 and older. Article on Planned Parenthood website

Today, we have many safe and effective birth control methods available to us PlannedParenthood.org Do Combined Oral Contraceptives delay a woman’s return to fertility? NO: International Planned Parenthood website YES: 1 to 2 month delay: PlannedParenthood.org

Do IUD’s, Implants or Injectibles cause Abortions? International Planned Parenthood – NO PlannedParenthood.org – “There is no Proof this actually happens”: American College of Obstetricians & Gynecologists (ACOG.org) – “Hormonal IUD thins the lining of the uterus. This keeps a fertilized egg from attaching….Copper IUD can prevent the egg from attaching to the wall of the uterus.”

A main reason people use contraception? A smaller # of children  better quality of life: International Planned Parenthood More kids  Happier marriage: San Francisco University study Very Happy 3.25 Pretty Happy 2.98 Not Too Happy 2.46 % Very Happy 7+ kids (74%) 1-6 kids (58%)

Healthy Alternatives to Hormonal Contraceptives
Effectiveness Rates Nothing % Spermicide % Withdrawal % Condom ~85% Oral Contraceptive (pill) ~95% IUD ~99% Sterilization % NFP % Abstaining %

Comparison of Artificial Methods of Birth Control and The Ovulation Method U.S. Statistics 1992

Natural Family Planning
Bleeding Dry Days Ovulation Pre-ovulatory “relatively” Infertile phase Post-ovulatory Fertile phase

Why Use NFP? Safe Healthy 100% natural Has no health risks
Does not involve potentially harmful birth control drugs or devices Healthy It teaches a woman to become aware of her normal fertility pattern. Changes in a woman’s fertility pattern can alert her to possible medical problems.

Advantages of Using NFP
Can be used to achieve or avoid pregnancy Effective in all reproductive circumstances: Regular or irregular cycles Breast feeding Pre-menopause Etc... Early detection and diagnosis of fertility disorders Immediately reversible No alteration of physiology No side effects Not technology dependant, no harmful devices

Advantages of Using NFP
Easy to Learn Easy to Use Minimal Cost Involves the Couple Morally Acceptable More satisfying marriages Divorce rates: 50% vs. 2%

U.S. Studies on Method Effectiveness of the Ovulation Method
Study Year Couples Cycles Preg. rate St. Cloud 1974 260 1823 0.6% Dolack 1978 329 3354 1.1% Klaus, H et al. 1979 1090 12,282 1.17% Klaus, H 1981 72 808 0% Wilson, M (Guatemala) 937 10,872 0.65%

Resources American Life League – www.all.org
Billings Ovulation Method Assn – Breast Cancer Prevention Institute – Couple to Couple League – International Planned Parenthood – Family of the Americas Foundation – National Institute of Health – One More Soul NFP Center – Pope Paul VI Institute – Planned Parenthood – University of San Francisco – World Health Organization –

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