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
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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
Overview
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How the Body Naturally
Works
History of Hormonal
Contraceptives
How Contraception
Unnaturally works
Planned Parenthood &
Hormonal Contraceptives
Healthy Alternatives to
Contraceptives
The Female Reproductive System
Pituitary Gland
Follicle-Stimulating
Hormone (FSH)
Ovaries
Estrogen
Cervix
Endometrium
Pituitary Gland
Luteininzing Hormone (LH)
Ovulation
Progesterone
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
Overview
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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
 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
History of Hormonal Contraceptives
 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
History of Hormonal Contraceptives
 Silphion Plant from Cyrene on an ancient coin.
 The plant created a huge economic boost for Cyrene
 The usage of the Silphion is implied
History of Hormonal Contraceptives
 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)
History of Hormonal Contraceptives
 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
History of Hormonal Contraceptives
 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
History of Hormonal Contraceptives
 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
History of Hormonal Contraceptives
 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
History of Hormonal Contraceptives
 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
History of Hormonal Contraceptives
 1965 Griswold v. Connecticut – US Supreme Court rules prohibition of birth
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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
History of Hormonal Contraceptives
 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
Overview
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
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

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
Birth Control Pills
Three Kinds:
• “Mini-pill” – progestin only
• Combination –
progesterone and estrogen
• Seasonale – longer
cycling
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
4) Lowers
efficiency
with which
the fallopian
tubes propel
eggs from
ovaries to
uterus.
3) Changes the lining of the
uterus so that the tiny baby boy
or girl cannot implant and grow.
CHEMICAL ABORTION
1) Prevents
ovulation from
occurring.
(Prevents
release of egg
from ovary.)
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
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
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)
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
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.
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“(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.”
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Despite the warning, the FDA gave Ortho Evra approval.
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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.
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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.
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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
Depo-Provera
Most widely-used
contraceptive injection in
the world that lasts three
months.
Mechanism of Action
• Prevents pregnancy by inhibiting
ovulation
• Abortifacient: alters normal
growth of endometrium and
prevents implantation of newly
conceived baby
• 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.
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
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)
• 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
FDA’s Approval of RU-486
FDA’s Approval of RU-486 (developed by the Population Council)
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The median total review time for new drug applications is 14.8 months
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FDA review time for RU-486 was 6 months.
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FDA quickly approved RU-486 on “fast track” process reserved for drugs
used for life threatening diseases
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RU-486 Expedited Clinical Trials
3-8% Unsuccessful
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Pain, Nausea, Cramps, Bleeding, Vomiting
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3% Required Blood Transfusions or Surgery
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Several Maternal Deaths linked to RU-486
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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.
Intra-Uterine Devices
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
Intra-Uterine Devices
• 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
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
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
What does Planned Parenthood have to say
about Oral Contraceptives?
 “(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
What does Planned Parenthood have to say
about Oral Contraceptives?
 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
What does Planned Parenthood have to say
about Oral Contraceptives?
 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.”
What does Planned Parenthood have to say
about Oral Contraceptives?
 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%)
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
Healthy Alternatives to
Hormonal Contraceptives
Effectiveness Rates
 Nothing
15%
 Spermicide
74%
 Withdrawal
81%
 Condom
84~85%
 Oral Contraceptive (pill)
92~95%
 IUD
98~99%
 Sterilization
99+%
 NFP
99+%
 Abstaining
100%
Comparison of Artificial Methods of Birth Control
and The Ovulation Method U.S. Statistics 1992
100%
90%
80%
70%
60%
Method effectiveness
User effectiveness
Continuation rate
50%
40%
30%
20%
10%
0%
OM
Pill
IUD Spermi Cond Diaph
Natural Family Planning
Pre-ovulatory
“relatively”
Infertile phase
Bleeding
Fertile
phase
Dry Days
Post-ovulatory
Infertile phase
Dry Days
Ovulation
Why Use NFP?
 Safe
- 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:
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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%
937
10,872
0.65%
Wilson, M 1997(Guatemala) 1999
Resources
• American Life League – www.all.org
• Billings Ovulation Method Assn – www.Boma-usa.org
• Breast Cancer Prevention Institute – www.bcpinstitute.org
• Couple to Couple League – www.ccli.org
• International Planned Parenthood – www.ippf.org
• Family of the Americas Foundation – www.familyplanning.net
• National Institute of Health – www.nih.gov
• One More Soul NFP Center – www.OMSoul.com
• Pope Paul VI Institute – www.popepaulvi.com
• Planned Parenthood – www.plannedparenthood.org
• University of San Francisco – www.userwww.sfsu.edu
• World Health Organization – www.who.int