R U - 486 BIRTH CONTROL?

Nancy Gettman and Deborah L. Vosler
1992 Woodrow Wilson Biology Institute

Time:

Purpose:

To introduce the uses, effectiveness, cost, advantages, disadvantages or contradictions, and ethical issues concerning birth control devices. RU-486, known as the French Abortion Pill, will be featured in this activity.

Materials:

Condoms (male & female), Birth Control Pill, IntraUterine Device (IUD), Spermicides (Foam, Gel, Film, Suppositories, Cream), Diaphragm, Sponge, Scalpel to portray sterilization, Cervical Cap, Hormone Releasing Capsule, Latex Plug, Douche, Syringe to indicate long-term Injectable Hormone, Calendar to portray the Rhythm Method, 1/2 inch Plastic Tubing to signify an Induced Abortion, Empty Gelcap to represent RU-486

1 Paper lunch sack for each contraceptive type

Empty paper lunch sack to depict Abstinence

Stapler/staples

Hazards:

Procedure:

1. Place each birth control device in a separate paper lunch sack. Fold the tops down and staple each sack closed.

2. Give each student a sack containing a different birth control device and instruct them to open their sacks. Students may work together or individually depending on the number of students and/or the number of birth control devices obtained.

3. Each student or group of students will research the background information regarding their specific birth control device. NOTE: After obtaining the various birth control devices, DO NOT discard the enclosed information sheet as this may be a valuable reference material.

   *Suggested areas of student research include:

   A) How does this birth control device work?

   B) What is the effectiveness of the birth control device?

   C) Determine the cost of each birth control device for one month, one year, a reproductive life cycle.

   D) Describe advantages and disadvantages/contradictions for the birth control device.

   E) What impact has this birth control device had on society con-cerning ethical issues?

4. Each student or group of students is responsible for providing a written and oral presentation.

5. Distribute the case study to each group of students. Using a collaborative learning process, students will consider and discuss the ethical issues presented. Refer to "A 3-D Case Study".

Assistance For Attached Case Study:

1. Summarize each birth control device with emphasis on RU-486.

2. Present the case study to the class. Suggestions include:

   A. Discussion with the entire class.

   B. Dividing the class into cooperative learning groups.

   C. Having students work alone.

   D. Using role playing techniques.

   E. A panel presentation having students determine the role that each will take.

   F. A panel presentation having students take an opposing viewpoint.

   G. Videotaping the class for further discussions.

   H. Setting up a debate.

   I. Being creative!

Discussion:

Refer to:

1. Available Methods of Birth Control

2. Future Methods of Birth/Fertility Control

3. RU-486 Addendum

4. A 3-Dimensional Case Study

Extensions And Activities:

1. This activity may lead to the ethical issues of abortion. You may want to introduce the history, legalities, techniques used, Roe vs. Wade, etc.

2. Invited Guest Speakers:
   A. Social workers
   B. Clergy from various denominations
   C. Physicians/Nurses
   D. Planned Parenthood

3. Suggested Field Trips:
   A. Planned Parenthood
   B. Pharmacy

Resources:

1. Samples of the various birth control devices may be obtained (often free) by contacting Planned Parenthood, medical agencies, pharmacies, company sale representatives, etc.

2. Suggested Video Material:
   A. Children Having Children (CBS, 1990)
   B. Teenage Sexuality (ABC News, Ted Koppel)
   C. China's Only Child (Nova)
   D. Teen Contraception (AIMS MEDIA)
   E. Check catalog from State's Health Department

AVAILABLE METHODS OF BIRTH CONTROL

Method of Birth Control	Preg/100 women/yr	Mode of Action	Advantages	Disadvantages
The "Pill" (estrogens and progesterone)	3 - 6	Inhibits secretion of FSH, LH: prevents follicle maturation and ovulation	Decreases menstrual pain and blood flow, lowers risk of PIDs & allows for sexual spontaneity	Weight gain, moodiness, water retention, breast tenderness, prescription required
Diaphragm with Spermicide	2 - 25	Blocks and kills sperm	Protects against STD, viable for 6 hours	Lack of spontaneity, MD administration
Intrauterine Device - IUD	1 - 6	Prevents or terminates implantation	Allows sexual spon-taneity, effective up to six years	Pelvic infection, excessive bleeding, physician placement
Condom - Male and Female	3 - 36 2 - 15	Blocks sperm	Inexpensive, protects against STD	Some loss of sensation
Sterilization Male & Female	<1	Fertilization prevention	"Safe, " allows for sexual spontaneity	Surgical risks, irreversibility
Hormone Releasing Capsule	<1	Inhibits secretion of FSH, LH: prevents follicle maturation and ovulation	Protection lasts 2-5 years, fertility return next cycle, may reduce endometrial cancer	Surgical risks, weight gain, menstrual irregularities, mood changes
Sponge with Spermicide	6 - 20	Blocks and kills sperm	24 hour protection, reduces risk of STD	Irritation, yeast infection
Rhythm	10 - 47	Abstinence during time of ovulation	Knowledge of cycle changes	Requires motivation
Douche	? - 85	Washes out sperm in the vagina	Restores pH, acts as a cleansing agent	May force sperm into uterus
Foam/ Film/ Gels/ Suppositories/ Creams	3 - 30	Kills sperm and may act as a barrier	Protects against STD, inexpensive, effective with barrier methods	Irritation, waiting period up to 4 hours, needs reapplication
Cervical Cap with Spermicide	4 - ?	Blocks and kills sperm	48 hour protection, reduces risk of STD	Irritation, lack of spontaneity, MD
RU-486: "The French Abortion Pill" Alone: With Prostaglandin:	20 - 35 4 - 10	Blocks action of progesterone and provokes uterine lining to slough off the embryo	Effective up to 7 wks after egg is fertilized, may be used to treat a number of different cancers and/or diseases	Small risk of excessive bleeding, physician administered in three office visits
Induced Abortion		0Abortifacient: removal of embryo	100% effective	Surgical risks, excessive bleeding
Total abstinence		0Refraining from sexual activity	Totally safe	None
Latex plugs	0 - ?	Temporary physical blockage of fallopian tubes	Allows for sexual spontaneity, highly effective	Accidental removal, irritation, physician administration
Injection Hormone: Depo-Provera	<1	Inhibits secretion of FSH, LH: prevents follicle maturation and ovulation	Lasts 1-3 months, fertility return by next cycle	Physician administered, moodiness, weight gain

FUTURE METHODS OF BIRTH/FERTILITY CONTROL

• Biodegradable implants that do not require surgical removal

• A 2-year pregnancy vaccine

• Male contraceptives that reduce sperm count

• Chemicals for nonsurgical sterilization

• Development of female and male sterilization techniques that will be more easily reversed

• Oves Disposable Cervical Cap

• Lea's Shield (silicone barrier)

• Unisex Condom Garment

• Fem Cap

To develop, test, and evaluate the safety of a new contraceptive, it generally takes 15 or more years and at least $50 million. Despite the importance of population control, annual worldwide expenditures on reproductive research and contraceptive development have declined from a high of $250 million a year to $200 million a year today Ñ an average of only 25 cents per person (Hanna 47).

At the present, the four most widely used methods for preventing pregnancy include sterilization, IUDs, oral contraceptives, and condoms. Injectable contraceptives and hormonal implants are also being used in some countries.

RU-486 ADDENDUM

RU-486 is a drug with substantial market potential that is not likely to be available in the United States in the near future. This delay in access to what many consider a proven drug is primarily due to the boycott threats and effective private and public sector lobbying of United States anti-abortion organizations (Hanna 43). Like the birth control pill, RU-486 has encountered strong resistance from moralists who fear it will trivialize sex, life, and human relations by "bolster[ing] the comparison between taking the drug and swallowing aspirin" (Glasow 7). Although there are many sectors against the use of RU-486, the Feminist Majority Foundation is funding efforts to bring the "French birth control pill," RU-486, into the United States. Individuals are making donations as high as $10 million to promote the use of this drug for research and as an abortifacient (Zeman 8).

RU-486 is not the only contraceptive drug held hostage to the abortion debate. The most advanced contraceptive, Human Chorionic Gonadotrophin (HCG) vaccine, has been tested by the World Health Organization (WHO) in Australia, the Dominican Republic, Finland, and India. It has not been tested in the United States because it acts by stimulating the immune system to attack the outer cells of the pre-embryo. Thus, abortion opponents classify it as an abortifacient rather than a contraceptive, although it works on embryos prior to implantation (Foreman, 1989).

Besides being safer than aspiration abortions and causing fewer side effects, RU-486 is relatively inexpensive. Tests on 8,000 women have shown that the drug has a very small risk of causing excessive bleeding. An abortion performed by a private physician in the United States costs between $500 and $2,000. Clinics usually charge $200 - $300 for the service. In France, the cost of an abortion using RU-486 is approximately $235. This includes the RU-486, the prostaglandin, and three medical visits (Abrams, 1988).

RU-486 causes an abortion by blocking the action of the hormone progesterone, thus provoking the uterine lining to slough off the embryo. Used alone, it is about 80 percent effective in preventing implantation of a fertilized egg if taken within five weeks after a missed period. If taken with a small dose of prostaglandin, a substance that makes the uterus contract, it is 95 percent effective up to five weeks after a missed period. After seven weeks, it is not very effective. After counseling and at least a one week waiting period, the pregnant woman receives a dose of RU-486 from her physician and must return two days later to insure a complete abortion.

The prospects for RU-486 in the United States are dim. At best, it could be available by 1997. It is unlikely that this drug will be legally available to women in the United States because of intense opposition from pro-life groups fearing that it will make abortions commonplace. Government-funded researchers are not allowed to test RU-486 or to develop other abortion drugs. No company has expressed interest in marketing RU-486 in the United States because of such pressure and fear of possible liability suits.

A 3-DIMENSIONAL CASE STUDY

What are the ethical and legal implications of the following scenarios?

• I. RU-486 is a controversial drug that is now widely used in France to terminate pregnancies. The FDA has blocked the use of this drug in the United States as an abortifacient. RU-486 interferes with the implantation of fertilized eggs in the uterus by binding tightly to the progesterone receptors in cells. Hormone regulating birth control devices (e.g. The Pill) use progesterone and estrogen to masquerade a "pseudo" pregnancy.

  When accompanied with prostoglandin, a progesterone antagonist such as RU-486 stimulates the changing of the endometrial lining of the uterus, thus provoking a rejection of the embryo. A decline in the progesterone level increases the contractibility of the muscles of the uterus and leads to a softening and dilation of the cervix which results in a sloughing off of the embryo.

  As a society we have approved the use of other forms of birth control that function in much the same way as RU-486. The intrauterine device (IUD) may act as an abortifacient by irritating the endometrial lining of the uterus. Further, the removal of the embryo by induced abortion is performed by dilation and aspiration in the first trimester.

  1. Why has the acceptance of RU-486 become a problem in the United States?

  2. Should RU-486 be approved as an abortifacient in the United States? Why or why not?

  3. Suggest some guidelines, policies and points-of-view for or against the approval of RU-486.

• II. RU-486 could be approved in the United States for non-abortion purposes. Having many promising applications, it has shown potential usefulness in dilating the cervix to help avoid cesarean sections and aiding in the delivery of a fetus that has died in utero. It is effective in the treatment of certain cancers that contain progesterone receptors including some breast and ovarian cancers. It has also been used to treat endometriosis (the third leading cause of infertility in the United States), Cushing's syndrome (a hormonal disorder in both men and women that is currently responding to the removal of the adrenal glands), some ulcers, hypertension, obesity, and osteoporosis.
  1. Assuming no law exists to handle RU-486, now what points would you include to regulate such testing and results? Why?

  2. If your mother has a type of breast cancer that could be treated with RU-486 and you could bring this drug illegally into the United States, what would you do? What ethical issues would the doctor have to encounter?

• III. Leona Benten, a pregnant, unmarried 29-year old California woman is challenging the Government's ban on importing RU-486. Ms. Benten obtained RU-486 in Europe and hoped to self-administer it to end her almost eight weeks of pregnancy. On July 1, 1992 at Kennedy International Airport, government agents seized the drug from her when she was trying to bring it into the country. The Supreme Court asked the Justice Department to explain why the government should not return the abortion drug to her. The officials of the Food and Drug Administration (FDA) believe that the case raises the issue of whether the agency has broad discretion to regulate the importation of unapproved drugs.
  1. What would you do if you were the FDA official in charge of this case?

  2. What was Ms. Benten's motive in bringing the drug to the United States even though she knew of the governmental ban?

  3. What should Ms. Benten do at this point?

  4. If you were Ms. Benten's attorney, how would you argue this case?

References:

Abrams, A. "Politics, profits and a new pill." Discovery (1988): 1.

Carey, John and Jonathan B. Levine. "Can the 'Abortion Pill' save lives?" Business Week 17 December, 1990: 56-57.

Findlay, Steven and Muadi Mukenge. "A user's guide to 14 methods. " U.S. News & World Report 108 (1990): 62-63.

Foreman, J. "Abortion: An American Divide" Boston Globe 23 April, 1989: 1.

Glasow, R. "RU-486: The Prostaglandin Connection." National Right to Life News 13 December, 1990: 7.

Green, Mark. "RU-486." The Nation 252 (1991): 836-837.

Hall, Elizabeth. "When Does Life Begin?" Psychology Today Sept (1989) 42-46.

Hanna, Kathi E. Biomedical Politics, Division of Health Sciences Policy Committee to Study Biomedical Decision Making. Washington D.C.: National Academy Press, 1991.

Hilts, Philip. "Thomas Expedites Suit on Abortion Pill." The New York Times 16 July 1992: A18.

Kieffer, George. "Bioethics." Lecture. Academic Director, Woodrow Wilson Institute on High School Biology, Princeton University. 5-31 July, 1992.

Lewin, Tamar. "Woman at Center of Debate: Model of an Ardent Feminist." The New York Times 16 July 1992: A18.

Miller, G. Tyler Jr. Living in the Environment: An Introduction to Environmental Science. California: Wadsworth Publishing Company Inc., 1990.

Seligmann, Jean. "A Condom for Women Moves One Step Closer to Reality. " Newsweek 119 (1992): 45.

Ulmann, Andre', George Teutsch and Daniel Philibert. "RU-486." Scientific American 262 (1990): 42-48.

Zeman, Ned and Lucy Howard. "Help for RU-486." Newsweek 118: (1990).

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