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Contraception Having a Healthy Baby at the Right Time Contraception has been practiced in some form since ancient times. The Petri Papyrus of Egypt, which dates to 1850 B.C., carries a prescrip- tion for a pessary made of sodium carbonate and honey. Another Egyptian formula of that time was crocodile dung mixed with a pastelike material. In the mid-1700s, Casanova recommended capping the cervix with half a lemon, from which the juice had been removed. Condoms date back to ancient Egypt and China, where men used sheaths made from animal membranes or oiled silk. The word "condom" was first used in England and may derive from the name of a Dr. Condom, who supposedly made a protective sheath for King Charles II to stem his number of illegitimate children. In the early 1900s, a movement to make contraceptives and family planning services available to U.S. women got under way with Margaret Sanger's first birth control clinics. The synthesis of two orally active progestogens in 1951, followed by the successful testing of these steroids as oral contraceptives, began a campaign for widespread access to birth control in the 1960s described by some observers as a "contraceptive revolution." The development of the birth control pill, plus a renewed interest in the IUD, came at a time when rapid population growth was being perceived as a threat to the global environment and to the economic and social health of many countries, particularly those in the Third World. 41

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42 SCIENCE AND BABIES ~ ' ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ 'A ~ ~ ~ ~ ~ I''' ~ ~~ ': ~ 5~' ~ ~ 5 ~ ~ . at ~ This scrap of papyrus is a prescription written in 1550 BC for a medicated tampon to prevent conception. Soaked in a mixture of honey and the fermented tips of acacia bush, the tampon was used as a vaginal suppository. Stewed acacia leaves produce lactic acid, an effective spermicidal ingredient also used in contraceptive ointments in the 1 940s and 1 950s. The papyrus was discovered by George Ebers in Luxor in 1873. Credit: National Library of Medicine In the United States, the increasing number of women entering the work force created new demand for the control that contraception could give over one's reproductive life. Stirred by these concerns, governments for the first time began to fund research on population and contraceptive development. The success of the pill encouraged the pharmaceutical industry to become vigorously involved in developing new contraceptives. By the mid-1970s, 13 pharmaceutical companies, 9 of them in the United States, were active in the field, and observers predicted that many new ap- proaches to contraception would soon be available. Expectations included a pill for men and a vaccine against pregnancy for women. As recently as 1982 the congressional Office of Technology Assessment estimated that

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CONTRACEPTION 43 by the end of this century more than 20 new or significantly improved technologies for contraception would be available. Although these expectations were based on the number of studies under way, interest and funding soon declined and the predictions have yet to become realities. In fact, the opposite has occurred. Writing in Family Planning Perspectives in early 1988, Richard Lincoln and Lisa Kaeser of the Alan Guttmacher Institute observed: If in the 1960s we saw the birth of a contraceptive revolution, then in the 1980s we are witnessing the failure of that revolution and the reversal of many of its hard-won gains. In the United States, where the pill and the modern IUD were first developed, contraceptive methods are disappearing faster than new ones can be introduced. Until very recently IUDs were almost unavailable to women in the United States; today only two models, the copper-releasing ParaGard and the progestogen-releasing Progestasert, are marketed. Injectable con- traceptives, such as Depo-Provera, which are used in practically every country of the world, are not allowed here. Several new birth control pills on the market in Europe cannot be prescribed in the United States, although they are considered safer. The pills contain new progestins that are thought to cause fewer adverse effects on the cardiovascular system than the older progestins. RU 486, an abortifacient and menstrual in- ducer, is being marketed in France and China, but at present there is no plan to seek the approval of the Food and Drug Administration (FDA) for use in this country. Lincoln and Kaeser state that clinical research on new contraceptive methods is practically at a standstill in this country; only two American pharmaceutical companies, Ortho and Wyeth, are doing any contraceptive research at all. In the United States, as in many countries, women begin having intercourse at a younger age than did women living earlier in this century. At the same time, many wish to have small families. Observes Dr. Malcolm Potts, president of Family Health International: The median age at which U.S. women have their last wanted child is 26.9 years, and 75 percent of all women have all the children they want by age 30. Even a contraceptive method with an annual failure rate of one percent that is used from age 30 to age 45 will leave one woman in seven with an unintended pregnancy. At first it may seem that there are many birth control choices in the United States, but close examination reveals the opposite. Oral contra- ceptives are used chiefly by women under age 30 because physicians are

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44 SCIENCE AND BABIES anxious about the cardiovascular side effects of the pill among women over age 35. Furthermore, misinformation about the possible health ef- fects of the pill discourages many young women and teenagers from using it. Also because of side effects, IUDs today are being prescribed only for women in mutually monogamous relationships who have at least one child. Barrier methods such as the condom and diaphragm are less effective than the IUD or the pill and are unattractive to many couples. Because their choices for truly safe and effective contraceptives are limited, American women often have long intervals during which they are not protected against the possibility of pregnancy. As a result, over 50 percent of them have unintended pregnancies, and thus the United States has a higher rate of abortions than most other industrialized countries. WHY THE DECLINE IN CONTRACEPTIVE DEVELOPMENT? Many factors played a role in the decline of contraceptive research and development. Some were economic; others were political and social. Research on reproduction and contraception is expensive and complex and takes years. Because reproduction is species specific, much of the experimental work must be conducted with humans, a pursuit that requires high-priced and sometimes unavailable liability insurance. In addition, some side effects, such as the thromboembolic effects of the pill, may develop only after extensive use and cannot be found beforehand, making the contraceptive business extremely vulnerable to litigation. Such risks do not encourage pharmaceutical companies to enter the field of contraceptive development. In fact, most of the companies that once were involved in this research have left, and other companies have reduced their commitment. Certain developments have accelerated the decline of contraceptive research, particularly research on entirely new contraceptive methods. The most harmful developments have been the proliferation of product liability suits and the sharp rise in liability insurance premiums. Other negative factors include the lack of both public and private financial support and a time-consuming FDA approval process. The Lawsuit Proliferation In 1982 the National Survey of Family Growth (NSFG) found that the IUD was the fifth most popular reversible form of contraception in

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CONTRACEPTION 45 the United States, with just over 2 million women using it. A few years later the three most commonly used IUDs were taken off the market. The Dalkon Shield, made by A.H. Robins Company, was removed from the market when a flood of damage suits were filed against it be- ginning in 1975. The design of the Dalkon Shield, which went on the market in 1971, before FDA approval of medical devices was required, was clearly associated with an increased risk of pelvic infection, subse- quent infertility, and, in some cases, death. The Robins Company knew of the potential hazards but denied them; other IUDs, which are free of the Dalkon Shield defects, have been suspect ever since. Until recently, G.D. Searle and Company made the only copper IUDs available in the United States. Copper-carrying devices have a lower pregnancy rate than noncopper ones and their association with pelvic inflammatory disease has been low. Nevertheless, Searle faces about 350 claims for damages and is appealing a jury verdict that awarded a plaintiff in Minnesota over $~.1 million. (The jury found Searle negligent in advertising and labeling its Cu-7 IUD.) Searle's cost of defending four lawsuits initiated in 1985, which it won, totaled $1.5 million. By the mid-1980s, both Searle and Ortho Pharmaceutical Corpora- tion decided to stop selling IUDs. Ortho based its decision on the fact that its market for the Lippes Loop was being eroded by an overall decline in IUD sales and by the increasing market share of the copper IUDs. Al- though its copper IUDs were popular, Searie decided to stop marketing them in North America. It continues to sell IUDs in 18 other countries, where it has encountered very few lawsuits. SearIe decided to leave the U.S. market because of the high cost of defending itself in liability suits and the difficulty of obtaining liability insurance. Currently, two IUDs are available in the United States: the Progestasert, made by Alza Cor- poration, and the copper-wrapped ParaGard, distributed by GynoPharma, Inc., under license from the Population Council. Carl Djerassi, a contraceptive expert at Stanford University, de- scribed other negative effects of liability litigation when he wrote: In 1980, several pharmaceutical companies claimed to have had more product liability claims for oral contraceptives than for all other drugs combined, notwithstanding that probably no group of currently used prescription drugs has been tested clinically as thoroughly as these steroids. It is not even the fact that few of these suits are won by the plaintiffs. It is just that the financial, human, and administrative costs of pursuing them are so high that few companies wish to expose themselves to such waste. Djerassi claimed that although most of the active ingredients in the

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46 SCIENCE AND BABIES birth control pills being used are off patent, generic equivalents are just beginning to appear on the market, no new companies are entering the field, and, in contrast to other drugs no longer under patent, the price of oral contraceptives is continually increasing. In 1985 the Upjohn Company announced it was phasing out its fertility research program. As its reasons the company cited the increase in adverse litigation, the long approval process, and rising insurance costs. Some observers suspect that hostility from antiabortion activists influenced Upjohn as much as anything else. Although Upjohn is no longer studying prostaglandins for their contraceptive value, the company continues to investigate the compounds as possible treatments for ulcers and cardiovascular disease. The increase in the number of lawsuits was not the only significant upward trend in the l980s. Jury awards became so large they made heacllines. Similarly, the cost of defending malpractice and product lia- bility lawsuits rose. A study by the Institute of Civil Justice at the Rand Corporation revealed that between 1982 and 1985 there was a 15 percent annual increase in the cost of defending both malpractice claims and product liability suits. The cost for defending more routine automobile claims rose only 6.3 percent annually. Changes in the Legal Rules During the past two decades, major modifications were made in the rules governing liability lawsuits, reports Deborah Hensler of the Institute of Civil Justice. The locality rule for malpractice suits was overturned, and new bases for bringing claims, setting damages, and measuring loss were established. Negligence was no longer necessary as a basis for a product lawsuit; instead, manufacturers could be held to new and strict concepts of liability. In many jurisdictions the statute of limitations was relaxed for injuries that might take more years to develop, and, as with malpractice, new ways of determining loss were introduced. In describing the result, Dr. Hensler notes, "There have been numerous small, substantive changes in the law that most people agree have increased grounds for plaintiffs to bring claims, increased their chances of being successful, and increased their chances, if they are successful, of winning large awards." Also during the past two decades important changes in procedural rules boosted the number of successful claims and drove up the amount of jury awards. For example, the rules governing "discovery" permitted

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CONTRACEPTION 47 a greater exchange of the information on which a lawsuit was built, an important factor in litigation that uses massive amounts of technical and medical data. Dr. Hensler notes that the proportion of large law firms has increased and more of them are specializing. In fact, some law firms concentrate on cases involving only particular products. In addition, attorneys today use computer technology to build data bases of the discovery documents developed for particular cases, and these data bases are being shared among lawyers nationwide. Two objectives of the tort liability system are to make restitution to injured people and to deter bad behavior. But studies have found that people with modest losses are overcompensated for their economic damages, people with large losses are undercompensated, and those with very large losses are severely undercompensated. As a method of making amends, the tort system is costly and not very equitable. How well does the system deter negligent behavior? Dr. Hensler believes that more attention is being paid by the medical profession to quality of care. Manufacturers of products, particularly risky products, seem to agree that their general level of consciousness about safety is higher than it was in the past. But the price for such consciousness raising also appears high and the method is not efficient. Unfortunately for manufacturers, medical care personnel, and insti- tutions that might look to litigation outcomes for performance guidelines, information produced by the legal system is not always clear or consis- tent. Court decisions vary from state to state and, within states, from jury to jury. It would be very hard to determine from reading just the appellate cases what the standard of a particular type of care should be. And the tort system may be overdeterring, causing beneficial services and products to be removed from the market. The withdrawal of most types of IUDs is one example. Dr. Hensler reports that surveys in 1983 and 1987 by the American College of Obstetricians and Gynecologists showed a sharp increase in the percentage of clinicians who said they were limiting their practice with regard to high-risk patients. The survey found that some specialists also no longer provide certain obstetrical services because of concerns about liability. The tort liability system and the regulatory system that has been built in this country do not always coordinate well. Many providers of medical care and products find themselves caught between the two. For example, FDA rules can be used as a basis for making judgments in tort liability suits while in the same lawsuits FDA rules are not allowed as a defense. There are controversies over these rules, and some efforts

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48 SCIENCE AND BABIES toward changing them are being made. Dr. Hensler has noted, however, that opposition to change is strong, in part because of concern for patient and consumer safety and in part because of bureaucratic reluctance. The chilling, unplanned-for effect of court decisions on medical care and on the availability of safe contraceptives is an indirect cost of these unsystematic and poorly understood changes in the tort system. Some observers believe it is time to focus on such consequences of the system and how they affect all who participate in the health care process. The Increased Cost of Insurance Consumers who are injured by a product may expect remuneration from the manufacturer, either through the courts or directly. Those costs, which can be extremely high, are covered by professional and product liability insurance. Conventional liability insurance from commercial in- surers has become either impossible to obtain or very expensive in recent years for many products and services, particularly for contraceptives. Large corporations in the field, such as Ortho, can afford liability insur- ance or can set aside profits for self-insurance. But although they may refine current products, they are deterred from developing new contra- ceptives. Public sector organizations, such as universities and nonprofit groups like the Population Council, which have been responsible for much of the contraceptive development and some of the field's more in- novative research, do not have the funds to pay for commercial insurance or to insure themselves. For smaller contraceptive developers, testing on human subjects has almost stopped because the availability of insurance to cover the testing is either not dependable from year to year or not available at all. But the cost and availability of liability insurance may not be related to the volume of lawsuits or to the cost of defending them. Some observers feel that the paradox is tied instead to interest rates and profitability: Liability claims rose at a time when interest rates on invested premiums declined, reducing the insurer's profit margin. When interest rates were high, critics say, insurers were interested in writing product liability insurance; when the rates dropped, insurers compensated by canceling policies held by contraceptive developers. Others in the field take a different point of view, saying that liability insurance for contraceptives is not feasible to underwrite because insur- ance companies simply cannot assess the liability exposure of a particular contraceptive product. Contraceptives appear to be an example of a class

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CONTRACEPTION 49 of mass-marketed products that have the latent capability of causing dis- ease and injuries among some users. Such products are viewed as having a highly uncertain but potentially enormous liability risk. Whatever the reasons, the high cost of insurance has had a distinct negative effect on contraceptive research and the development of new methods. Individual states and the U.S. Congress are considering a range of bills that would reform both the tort system and liability insurance laws. Whether these reforms are passed and whether contraceptives will be covered by such legislation seems unlikely in the near future. The Funding Gap Funding for contraceptive development by the pharmaceutical indus- try and by governments worldwide peaked in 1972 at $74.3 million. It dropped substantially three years later, and by 1983 spending leveled off at just under $57 million, spread over 384 research projects involving 70 variations of potential contraceptives. That amounted to just un- der $150,000 per project. Ortho says that bringing a new contraceptive method from the laboratory to the market costs the company about $125 million and the process generally takes 10 years, or $1.25 million per year for one type of contraceptive. Modifications of existing drugs require less time and money. The low level of funding has had several results. Most obvious is that the focus of research has not been on the expensive process of discovering new methods of contraception that would be either safer or more accept- able to people for whom present methods are not an option. Instead, efforts have concentrated on the less expensive process of modifying ex- isting drugs. Consequently, most of the contraceptives currently available here and abroad are based on the progestogens synthesized almost 40 years ago, including injectable steroids such as Depo-Provera, steroid- releasing implantable capsules, and steroid-releasing vaginal rings. Skimpy funding slows the development of new contraceptives by limiting the number of drug combinations or formulas that can be explored at a time. Lincoln and Kaeser state that the new Norplant implantable capsules could have reached the market many years earlier if more money had been available during its early years of research. Sixteen years passed before Norplant was marketed in any country. In the United States today there is less basic research under way at universities and other nonprofit institutions than there has been since the early 1970s. At $9 million for fiscal 1989, federal funding for

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so SCIENCE AND BABIES contraceptive research and development is extremely low. Low levels of private and government support tend to discourage young scientists from entering the field, inhibiting new discoveries and the use of new knowledge from other areas for contraceptive development. FDA Requirements In 1962, after the thalidomide tragedy, the FDA developed new procedures to test the safety and efficacy of drugs. Conforming to the new mandates lengthened the overall time required for drug development. A later change that had a considerable effect on the development of contraceptives was a requirement for very stringent toxicology and carcinogenicity testing in animals for new contraceptives. For other noncontraceptive drugs, the choice of animals, usually rats and rabbits, was left to the investigating scientist, and the required lengths of the repeated-dose toxicity studies used to evaluate the cumulative effects of drugs were 2 weeks, 4 weeks, and 6 months for Phases I, II, and III, respectively. For contraceptive drugs, however, testing requirements were made stiffer. The FDA insisted that toxicology testing be performed in rats, dogs, and monkeys and that it extend for 90 days, 1 year, and 2 years for each of the three phases. While carcinogenicity testing for other drugs consisted of 2-year rat and 18-month mouse trials, for contraceptives those tests had to be "lifetimes' trials of 7 years in dogs and 10 years in monkeys. Dr. C. Wayne Bardin, vice president of the Population Council, observes that, "In retrospect, the toxicity testing in animals correctly predicted that steroidal contraceptives were relatively free of risk com- pared to other drugs." But such testing, he said, "was not successful at predicting many of the rare but serious adverse effects of hormonal contraceptives, such as thromboembolism and hypertension." Not surprisingly, the very high doses used in the animal studies produced diseases in dogs that had not been observed in humans. As a result, many contraceptive drugs were withdrawn from development on the basis of what in retrospect appears, Dr. Bardin says, to be spurious observations in animals. In early 1988 the FDA revised its requirements for testing con- traceptive steroids to conform more closely to the guidelines espoused by the World Health Organization (WHO). Today for the first time FDA

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CONTRACEPTION 51 requirements for testing contraceptive drugs are almost identical to the requirements for other drugs. In its guidelines the WHO does not recommend beagle and mon- key studies for contraceptive drugs because available data indicate that findings of certain cancers in these animals are not accurate predictors of such cancers in humans. Still time-consuming and expensive, however, is the amount of doc- umentation needed to get FDA permission for clinical trials. The annual reports on such studies must be written in substantially more detail than in the past. Other countries are also requiring increasingly detailed doc- umentation. For large companies this means the expense of thousands of man-hours. For the smaller public sector organizations, the requirements can be almost impossible to meet; at best, the requirements add years to the process before a contraceptive can be made available to the public. Pharmaceutical companies gain financial support for their research on both successful and unsuccessful contraceptive products from the sales of those products that do reach the market. Their profits increase with the length of time they have exclusive rights to the product while it is under patent. Until such exclusivity was extended somewhat in 1985, patent protection lasted 17 years. Under the original FDA approval process, contraceptive development in the United States took a long time, sometimes almost the entire life of the patent. With little opportunity to recoup their costs, pharmaceutical companies have had little incentive to develop new contraceptives. In 1988 Dr. Potts noted: By the time manufacturers bring a new formulation to the marketplace, half or more of the 17-year patent life may be over, so there is little commercial incentive for expensive postmarketing surveillance. Either we need to make premarket testing cheaper and postmarketing surveillance obligatory or we need to find federal money to support the necessary postmarketing studies. The clinical trials required by the FDA generally are two years long and seldom utilize more than 2,500 women. These clinical trials and the animal tests performed before the drugs are approved for marketing cannot detect the infrequent but serious side effects that may appear only after long-term use in a large number of women. The WHO has suggested that the health of contraceptive steroid users might be better protected if more emphasis were placed on postmarketing surveillance and less on animal testing. Organized postmarketing surveillance programs may prove to be more consistent and accurate in documenting any long-term adverse effects of contraceptives.

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58 SCIENCE AND BABIES sexually active women at risk of unintended pregnancy who do not use any method of contraception. As Mahmoud F. Fathalla of the World Health Organization put it, there will always be a "yes" group of highly motivated people who want to use contraception and a "no" group of those ideologically opposed to the concept. But in between there is a large group for whom the availability of inexpensive and convenient methods could tip the balance toward their using contraception. A contraceptive may be highly effective, inexpensive or free of cost, and readily available and still not be used, because the technology is unattractive to that particular population. The acceptability of a contra- ceptive method depends a great deal on how it fits into the perceptions, culture, or life-style of the prospective user. Social scientists have observed that modern contraceptives have cer- tain inherent attributes, such as the sex of the user, the relationship to coitus, the need to handle the genitalia, or the need for repeated appli- cations. Susan C.M. Scrimshaw of the University of California at Los Angeles School of Public Health explains that each of these inherent attributes elicits different responses in different cultures. For example, cultures in which women are not allowed to cook for their families during episodes of vaginal bleeding (as in India) are less accepting of the IUD, which is associated with increased bleeding. Dr. Scrimshaw found that women in Spanish Harlem prefer sterilization as a birth control method because they had to confess that to their priest only once. Some men and women will not use diaphragms, condoms. or cervical cans because they dislike handling their genitals. ~-r ~ --A In addition to the inherent attributes, a set of"perceived" attributes tend to grow around each contraceptive method. Dr. Scrimshaw says: While these attributes, such as the notion in Ecuador that the birth control pill "eats the red blood cells," are not true, they nevertheless affect acceptability. If people believe them, they are likely to reject the method just as they would for a culturally or individually undesirable inherent attribute. It is also possible to have culturally acceptable methods and to deliver them in such a way that they are used only minimally. Research has shown that factors such as the type of clinic, its location and hours, the attitudes or other characteristics of the staff, the tone of staff-to- patient interaction, and communication with the community all may have an impact on the acceptability of a program. The cost of a contraceptive method also is a major factor in its acceptability. Cultural customs also

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CONTRACEPTION 59 can play an important role. Six months after birth control pills were supplied directly to women in Iran, only 12 precept of the women were still taking them. When the pills were distributed to the husbands to give to their wives, 90 percent of the women continued to take them after six months. To make contraceptive methods attractive and acceptable to varied ethnic groups, it is sensible to fit the technology to the people, rather than the people to the technology. Although additional basic research is needed to develop more contraceptives, those in existence could be utilized more fully if they were made acceptable to more populations. Dr. Scrimshaw believes acceptability can be enhanced by utilizing information from the behavioral and social sciences: It is difficult to measure behavior accurately and consistently and even more difficult to predict it. But when new technologies and programs are launched without any such measurements, not only can costly errors occur, but it may be years before it is even clear the programs aren't working. It is important to note that not all contraceptives are distributed via clinics. Many are successfully marketed to the general public by being sold over the counter in pharmacies and other retail outlets, including the smallest village shops. In some countries oral contraceptives are vigorously advertised; in many communities they are widely available without a prescription. In some areas the pill is available from village women who have been trained to screen prospective users for contraindi- cations. Subsidizing the price of contraceptives also has made them more acceptable and cost-effective. No single method can meet the needs of one woman or one couple, much less the needs of an entire population, particularly in a heteroge- neous country such as the United States. For contraceptives to be used effectively, a "contraceptive supermarket" is necessary, Dr. Djerassi says, "from which people can pick and choose, because there is no such thing as an ideal contraceptive" for all populations. HINDERING CONTRACEPTIVE USE Why does the United States differ so markedly from other industrial- ized countries in behaviors associated with reproductive health? Thirteen percent of sexually active unmarried women of childbearing age in this country do not practice birth control. Why is this so? In its study of unin- tended pregnancy, contraceptive practice, and family planning services in

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60 SCIENCE AND BABIES 20 industrialized nations, researchers from the Alan Guttmacher Institute noted these contrasts between the United States and similar countries: In other countries contraceptive care is integrated into primary health services and is available at locations that are many, familiar, and convenient. This is not true in the United States. In many countries where the use of effective methods is high and pregnancy and abortion rates are low, contraceptive care is delivered chiefly by family physicians rather than by specialists. The family physi- cians are especially likely to prescribe oral contraceptives. In the United States obstetricians and gynecologists provide most contraceptive care. Family planning clinics in other countries are designed to serve mostly first-time contraceptive users and other groups who may require special counseling. They frequently offer evening or weekend hours, female personnel, and a variety of contraceptive choices. In contrast, U.S. clinics are meant to provide free or low-cost services to people too poor to obtain contraceptive care from private physicians. In the United States the choice of a caregiver is determined by the patient's financial state; in other countries the determinant is the patient's needs. The choice of contraceptives in the United States is narrower than in other countries. A number of improved or entirely new methods. including injectable contraceptives and lower-dose formulations of the pill, are not available. In most of the countries studied, but not in the United States, contraceptives are free or inexpensive. Information about contraception and sexuality is widely dissem- inated in some other countries through advertising, publicity, education, or the distribution of literature from pharmacists. In countries where the condom is widely advertised, for example, it tends to be more widely used. Two other major barriers hinder U.S. women from using contracep- tives. One is the widespread absence of information, especially among the young and not well educated, about the dangers of getting preg- nant and about contraception. The other is the negative attitude held by a sizable proportion of women toward the most effective contracep- tive methods. Furthermore, in other nations contraceptive information and advertising are disseminated through the media, including national television. Although the conventional thinking in the United States is that most Americans do not want sex education in the schools and do

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CONTRACEPTION 61 not want to have contraceptives advertised on national television, recent nationwide opinion polls show the reverse to be true. A 1985 Gallup poll found that three-fourths of Americans want sex education to be taught and that they thought it should be done before high school. A 1987 survey by the Louis Harris organization found that most Americans have no religious or moral objections to family planning. Six out of 10 questioned approved of advertising contraceptives on television. Seventy-two percent, including 73 percent of Catholics and 60 percent of Evangelicals, said contraceptive advertising would not offend people like themselves. The Harris poll also reported that 76 percent of Americans thought "if young people saw that TV stars they admire use birth control," they would be more likely to use it themselves. A smaller survey of 800 adults conducted about the same time by NBC and the Wall Street Journal found that 79 percent of respondents approved of contraceptive ac vert~s~ng. Favorable attitudes are a prerequisite for the use of birth control. Better dissemination of information would help eliminate the barrier to contraceptive use caused by negative attitudes toward the pill and the IUD, according to the Gallup poll and a 1987 Guttmacher study of women at risk for unintended pregnancy. Those surveys found that women avoid using the pill and IUD, the most effective methods, because they fear potential health risks. Women also underestimate the efficacy of these methods. Their concern is understandable. In recent years there have been many news articles about the lawsuits over damage caused by the Dalkon Shield IUD. Most cases of pelvic inflammatory disease (PID) associated with the IUD are related to exposure to sexually transmitted diseases. In addition, insertion of an IUD may introduce bacteria into the genital area, which is why so many of the infections appear early. Because PID can lead to infertility, IUD use today is limited to women who already have at least one child and are in a mutually monogamous, stable relationship. A 35-member American Medical Association Diagnostic and Ther- apeutic Technology Assessment panel recently pronounced the Proges- tasert and the ParaGard the two {UDs available in the United States- safe and effective when users are carefully selected. The opinion of the panel is important because an IUD fills an important niche in birth con- trol: It offers effective contraception for the mature woman for whom oral contraceptives may no longer be ideal. Studies of oral contraceptive use show that the pill is much safer than

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62 SCIENCE AND BABIES U.S. women believe. The mortality risk has dropped with the increased use of modern-day pills and the discouragement of pill use among women over age 35 who smoke. As Malcolm Potts says, "If analysis of the health impact of oral contraceptive use is limited to cardiovascular risks and to the prevention of ovarian and uterine cancer, the good and bad effects- virtually cancel each other out." It is certain that the pill has no important adverse or beneficial effects on breast cancer. However, more information is needed about the pill's relationship with that very small but tragic group of women who develop breast cancer before age 45. Several recent, small epidemiological studies suggest a link between pill use at an early age (before age 20 or the first pregnancy) and early breast cancer. Because of inconsistencies among these studies, the FDA believes the new evidence is not clear cut enough to warrant changing the prescribing rules for oral contraceptives. Nevertheless, the possible association between the pill and breast cancer in young women is an important concern, and a broad investigation is under way at the Institute of Medicine. Regular and accurate updates on the safety and efficacy of contracep- tives are important in keeping women apprised of contraceptive facts. A flow of accurate information will help women of all ages and educational backgrounds find a contraceptive that is right for them. CONCLUSION Contraceptives are not new, yet their development and use in the United States are impeded by substantial obstacles. Contraceptive de- velopment is markedly hindered by a lack of funds, the proliferation of lawsuits, exorbitant jury awards, and an absence of liability insurance for contraceptive manufacturers. Many men and women in this country are badly informed about birth control and about the true effectiveness and health risks of the methods that are available. Half the pregnancies in this country are unintended, and the United States has one of the highest rates of abortion and teenage pregnancy among industrialized countries. Better contraception is needed in the United States and throughout the world to broaden the choice of effective approaches so that men and women of diverse ethnic backgrounds can find con- traceptives with which they are comfortable. The experience of other nations suggests that to reduce the number of unintended pregnancies and abortions in this country, particularly among teenagers, we must

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CONTRACEPTION 63 make contraceptives more easily available and we must be more vigor- ous in our dissemination of information about birth control and family planning. Birth Control Methods Available in the United States Today and Their Effectiveness Sterilization for men and women is the leading method of contracep- tion in the United States; it is safe and 100 percent effective. In general, it is not reversible, although sophisticated new sterilization methods are being developed that may make it possible to reverse the procedure in some cases. Birth control pills are 95 to 99 percent effective and need less plan- ning than other substantially effective methods such as the diaphragm and condom. They do not require any handling of the genitals nor do they interrupt foreplay. Modern-day pills that combine low doses of es- trogens and progestogen have fewer adverse effects on the cardiovascular system than the pills of 30 years ago. A mini-pil1 with no estrogen is available for women who are breastfeeding or over age 35 and smoke. The combination pill is not recommended for lactating women. Although oral contraceptives may have undesirable side effects for some individ- uals, they protect against cancers of the ovaries and uterus and against excessive menstrual bleeding. Intrauterine devices are 98 to 99 percent effective. Of the two types currently available, the copper-releasing Paragard needs to be changed ev- ery 4 years, the progestogen-releasing Progestasert once a year. Because IUDs have been associated with an increased risk of pelvic inflammatory disease, which can cause infertility, the makers of IUDs recommend that they be used only by women who have had at least one child and are in a stable, mutually monogamous relationship. After an IUD is inserted by a trained health care provider, it requires only an occasional check by the wearer to ensure that it is still in place. The condom is growing in popularity because it is readily available and offers good protection against sexually transmitted diseases, particu- larly those brands coated with a spermicide. Spermicide creams or foams can be added to the inside and outside of a condom for extra protection. The failure rate ranges from 3 to 15 percent, with failure often ascribed to careless use. Because condoms can leak or break, experts recommend

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64 SCIENCE AND BABIES that the female partner use a spermicide foam as extra protection. Con- doms have no adverse side effects, although the spermicide coating may cause an allergic reaction in some men and women. The diaphragm produces few side effects; it can cause urinary tract infections, and some women may be allergic to the spermicidal cream or jelly that must be used with it. Its failure rates range from 2 to 20 percent, with most failures arising from improper or inconsistent use. If used consistently, however, experts believe the diaphragm is highly effective. In addition, it offers some protection against sexually transmitted diseases. The diaphragm must be fitted by a health care provider, and the fit must be checked by a health professional every few years or after childbearing or a substantial weight chance. Norplant, a contraceptive implant, steadily diffuses a low dose of the progestin levonorgestrel directly into the bloodstream. Norplant is more effective than oral contraceptives and is free of estrogen. It can cause menstrual irregulatory, but thus far has produced no serious side effects. Norplant capsules are surgically inserted under the skin of the arm by a trained health care provider and protect against pregnancy for 5 years. The capsules should be removed at the end of that time because they become less effective. They can be removed earlier if desired. The United States will be the thirteenth country to approve Norplant for use; the method is in clinical trials in some four dozen other countries. Sponges, foams, creams, jellies, and vaginal suppositories are easier to obtain because they can be bought in a drugstore and are easy to use. They do have a failure rate of 3 to 21 percent. Researchers do not know if this relatively high failure rate is due to inconsistent use or to inadequacies inherent in the methods. These vaginal methods protect against pregnancy by inactivating the sperm. To be effective, the sponge must be kept in place for at least 6 hours after intercourse. To avoid possible side effects, it should be removed after 24 hours. Because the _z~_ me, . same active ingredient, nonoxynol-9, is used in all of these products, if a woman is allergic to one product, she cannot use any of them. The cervical cap resembles a small diaphragm. It is filled with a spermicidal foam or jelly and placed over the cervix. As effective as a diaphragm, it has an added advantage in that it can be inserted several days before intercourse and can be left in longer afterward. If left in place too long, the cervical cap begins to have an odor. Some users report that the cap, which is smaller than a diaphragm, allows more sexual pleasure; it also may be a better choice for women with recurring urinary

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CONTRACEPTION 65 tract infections. Accurate placement requires practice. Since receiving EDA approval in 1988, cervical caps have been manufactured in the United States; they are available chiefly in large population centers, often through women's health groups. Birth Control Methods on the Horizon for the United States A number of fertility-regulating methods may be available in the United States in the next 10 to 15 years if sufficient funding is made available. When funding is in short supply, research efforts must be cut back. As a result, development can be stretched out over many more years, delaying the availability of new methods. Two types of vaginal rings that release steroids into the bloodstream via the vaginal epithelium are being studied by the Population Council and the World Health Organization. One releases a combination of estrogen and progestogen and is worn for 3 weeks; the other, which releases the progestogen levonorgestrel, is worn continuously for 3 months and is designed for women who are breastfeeding. The rings are self-inserted. Although they can cause irregular bleeding, they have fewer side effects than the pill. Their effectiveness appears to be high, but studies are not yet complete. Biodegradable pellets of norethindrone or levonorgestrel, implanted just under the skin, are effective for 12 to 24 months. They appear to be highly effective and are now undergoing clinical trials. A female condom is being developed. Like the male condom, it would protect against sexually transmitted diseases, would be readily available, and has no apparent side effects. Used with a lubricant, it is inserted by the woman. Transdlermal delivery of hormones is a method that releases con- traceptive steroids slowly into the circulatory system through the skin via a patch worn on the body. In the system currently being studied in the United States, a new skin patch is applied each week for 3 weeks, followed by a week without a patch to allow menstruation to occur. Birth Control Methods Not Available in the United States Injectable contraceptives Depo-Provera and Norigest appear to be highly effective and are convenient. Currently, both injectables are available in the United States for menstrual problems and endometriosis but not for birth control. Depending on the dosage, the slow-release

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66 SCIENCE AND BABIES injection into a muscle can be given every 3 or 6 months. The larger, longer-lasting dose may produce more side effects, such as headaches, weight gain, depression, and irregular bleeding. Injections of progestogen alone can cause irregular menstrual bleeding, but another formulation that adds estrogen appears to produce regular bleeding patterns in most women. Widely used in many countries, injectables are still being studied for contraceptive use in the United States. The CuFix 390 intrauterine device is a string of hanging copper rings, a design that lessens the chance of pain, bleeding, and expulsion that is sometimes associated with IUDs. It has perfo~-~ed well in early trials in other countries, but because of the product liability climate in the United States, its manufacturers might not seek marketing approval here. Abortifacients and menstrual inducers fill a major need in current birth control technology because they can be used a few days or weeks after unprotected intercourse to induce menstruation. The most studied is the antiprogestin, mifepr~stone, known as RU 486, which is available in France and China. A dose of 600 milligrams of mifepr~stone followed by 1 to 10 milligrams of prostaglandin brings on menstruation in over 95 percent of the women who use it. The use of RU 486 requires medical supervision. Although any attempt to market this drug in the United States is expected to lead to protests from antiabortion segments, the laws of many countries permit "menstrual therapy" even when surgically induced abortion is not allowed. Although new methods of postcoital contraception will certainly be opposed by some members of society, in many parts of the world an inexpensive self-administered menstrual inducer is expected to receive broad acceptance. ACKNOWI,EDGMENTS Chapter 3 was based in part on presentations by Carl Djerassi, Deborah Hensler, Malcom Potts, and Susan Scrimshaw. REFERENCES American College of Obstetricians and Gynecologists. 1985. Gallup poll shows what public knows and thinks about birth control. Press release, March 6. Washington, D.C. Atkinson, L.E., R. Lincoln, and J.D. Forrest. 1985. Worldwide trends in funding for contraceptive research and evaluation. Family Planning Perspectives. 17~51:196- 207.

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CONTRACEPTION 67 Atkinson, L.E., R. Lincoln, and J.D. Forrest. 1986. The next contraceptive revolution. Family Planning Perspectives. 18(1): 19-26. Bardin, C.W. 1987. Public sector contraceptive development: history, problems, and prospects for the future. Technology in Society. 9:289-305. Cushner, I.M. 1986. Reproductive technologies: new choices, new hopes, new dilemmas. Family Planning Perspectives. 1 8(3 ): 1 29- 1 3 2. Diagnostic and Therapeutic Technology Assessment panel. 1989. Questions and answers: intrauterine devices. Journal of the American Medical Association. 261(14):2127-2130. Djerassi, C. 1987. Contraception in the year 2001. In Contraception in the Year 2001, edited by P.A. van Keep, K.E. Davis, and D. de Weld. Amsterdam: Elsevier Science Publishers. Djerassi, C. 1989. The bitter pill. Science. 245 :356-361. Ehrlich, P.R. 1968. The Population Bomb. New York: Ballantine Books, Inc. Family Health International. 1987. Women's perceptions of the safety of the pill: a survey in eight developing countries. Co-ordinator: Gary S. Grubb. Journal of Biosocial Sciences. 19:313-321. Fathalla, M.F. 1988. New contraceptive methods and reproductive health. In Pro- ceedings of the Conference on Demographic and Programmatic Consequences of Contraceptive Innovations, edited by S. Segal, A. Tsui, and S. Rogers. New York: Plenum Press. Forrest, J.D. 1986. The end of IUD marketing in the United States: what does it mean for American women? Family Planning Perspectives. 18(2):52-55. Forrest, J.D. 1987. Unintended pregnancy among American women. Family Planning Perspectives. 19(2~:76-77. Forrest, J.D. 1988. U.S. women's contraceptive attitudes and practice: how have they changed in the 1980s? Family Planning Perspectives. 20~3):112-118. Forrest, J.D., and S.K. Henshaw. 1988. Effects of new contraceptive methods on abortion utilization. In Proceedings of the Conference on Demographic and Programmatic Consequences of Contraceptive Innovations, edited by S. Segal, A. Tsui, and S. Rogers. New York: Plenum Press. Grimes, D.A. 1986. Reversible contraception for the 1980s. Journal of the American Medical Association. 255(19:69-74. Alan Guttmacher Institute. 1985. Risk of developing primary infertility is at least twice as high for IUD users as for never-users. Family Planning Perspectives. 17(4):182-183. Alan Guttmacher Institute. 1987. Poll says most people accept family planning, approve of condom ads. Family Planning Perspectives. 19(2~:79. Hatcher, R.A., D. Kowal, F. Guest, et al. 1989. Contraceptive Technology: Interna- tional Edition. Atlanta: Printed Matter, Inc. Henshaw, S.K. 1987. Characteristics of U.S. woman having abortions, 1982-1983. Family Planning Perspectives. 19(1):5-9. Henshaw, S.K. 1988. The characteristics and prior contraceptive use of U.S. abortion patients. Family Planning Perspectives. 20(4): 158-168. Jones, E.F., J.D. Forrest, S.K. Henshaw, J. Silverman, and A. Torres. 1988. Unintended pregnancy, contraceptive practice and family planning services in developed countries. Family Planning Perspectives. 20(2):53-67.

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68 SCIENCE AND BABIES Kolata, G. 1989. For those concerned with pill risk, a look at the choices. N.Y. Times. January 12, B-10. Lincoln, R., and L. Kaeser. 1988. Whatever happened to the contraceptive revolution? Family Planning Perspectives. 20(1):20-24. Mosher, W.D., and C.A. Bachrach. 1987. First premarital contraceptive use: United States, 1960-82. Studies in Family Planning. 18(2):83-95. PATH and PIACT. 1987. FDA may follow WHO guidelines for contraceptive steroid testing. Outlook. December, 9-10. PATH and PIACT. 1988. FDA confirms new requirements for steroid testing. Outlook. March, 10. PATH and PIACT. 1988. More contraceptive choices likely by end of century. Outlook. 6(41:2-8. Population Crisis Committee. 1985. Issues in contraceptive development. Population No. 15 May. Washington, D.C. Potts, M. 1988. Birth control methods in the United States. Family Planning Perspec- tives. 20(6):288-297. Rosoff, J.I. 1988. Not just teenagers. Family Planning Perspectives. 20(2):52-67. Silverman, J., A. Torres, and J.D. Forrest. 1987. Barriers to contraceptive services. Family Planning Perspectives. 19(3):94-102. Special Programme of Research, Development, and Research Training in Human Reproduction. 1987. Guidelines for the Toxicological and Clinical Assessment and Postregistration Surveillance of Steroidal Contraceptive Drugs. Geneva: World Health Organization. Skuy, P. 1976. A history of contraception: how far have we really come? Canadian Pharmaceutical Journal. 109(11):3/335-5/337. Toufexis, A. 1989. Too many mouths. Time. January 2, 48-50.