Contraceptive Research and Development Looking to the Future (1996) / Chapter Skim
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6 The Translators: Sectoral Roles in Contraceptive Research and Development
6 The Translators: Sectoral Roles in Contraceptive Research and Development
Pages 166-235
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From page 166... ...
The first is a qualitative look at present market demand as expressed in overall patterns of contraceptive use, worldwide and in the United States. The second focus is on specific areas of contraceptive need that seem most readily translatable into market demand, that is, "niches" that are either empty or quite inadequately filled.
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From page 167... ...
The chapter closes with a discussion of the cost-effectiveness of contraception and what that might mean as an incentive to investment in contraceptive R&D and the intimate and necessary relationship of that investment with the market for contraceptive technologies. CURRENT CONTRACEPTIVE USE Contraceptive Use Worldwide Contraceptive prevalence2 among women currently married or in union (a group designated by the abbreviation MWRA, or "married women of reproductive age")
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From page 168... ...
Women of reproductive age, 784,897 953,815 married or in union (MWRA) a Contraceptive users 457,759 625,521 among all women Contraceptive users among 445,692 602,417 married/in union women aMWRA = married women of reproductive age, defined as "married or living with a man," vis-àvis "now widowed, divorced, or no longer living together." SOURCE: United Nations Population Fund.
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From page 169... ...
These rates are subsequently applied both to the number of MWRA (married women of reproductive age) and to the number of unmarried women who use contraception; the fact that there are now data from 34 countries for this second population group makes its inclusion in global calculations of contraceptive prevalence possible for the first time.
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From page 170... ...
. Contraceptive Use in the United States In 1988, over two-thirds of women of reproductive age in the United States were at risk of unintended pregnancy, that is, they were sexually active and did not want to become pregnant but would be physically able to become pregnant if they or their partner used no contraceptive method (Forrest 1994b)
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From page 171... ...
The broad pattern changes since the availability of oral contraceptives beginning in 1960 have been: • Increase in total contraceptive use and pill use between 1955 and 1965 and decreased use of the diaphragm, condom, and periodic abstinence. • Steep increase in interest in coitus-independent methods and in method efficacy.
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From page 172... ...
In the U.S. National Survey of Family Growth, "Other" included jellies and creams, suppositories and inserts, the Today sponge, douche, diaphragm, foam, periodic abstinence, and withdrawal.
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From page 173... ...
. Table 5-6 presents the risks and side effects of currently available contraceptive methods; it also presents their noncontraceptive benefits.
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From page 174... ...
c"Other" includes vaginal methods, periodic abstinence, and withdrawal. dDepo-Provera.
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From page 175... ...
= married women under 45.
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From page 176... ...
Among women with health concerns, contraceptive prevalence is reduced by an average of 86 percent for the IUD, 71 percent for the pill, and 52 percent for sterilization (Bongaarts and Bruce 1995)
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From page 177... ...
New York: The Alan Guttmacher Institute, March 1993. For 1995, Ortho Pharmaceutical Corporation, Executive Summary: 1995 Ortho Annual Birth Control Study.
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From page 178... ...
, weight gain, and risk of anemia; decreased breast tenderness, depression, menstrual pain; suppression of delay in return of fertility, pain associated with ovulation; decreased HDL cholesterol levels, decreased frequency of seizures headaches IUDs None known; progestin-releasing Slight increase in risk of PID in Menstrual cramping, spotting, IUDs may decrease menstrual first 20 days after insertion; increased bleeding blood loss and pain perforation of the uterus, anemia; not protective against viral STDs, including HIV/AIDS Oral contraceptives Protects against acute infection of Estrogen-associated: slight Estrogen-associated: nausea, the fallopian tubes (PID) , ovarian increase in blood clot headaches, fluid retention, weight and endometrial cancers, benign complications, stroke, liver gain, increased breast size, breast breast masses, ovarian cysts; tumors, hypertension, heart tenderness, stimulation of breast decreased ectopic pregnancy; attacks, cervical erosion or tumors, watery vaginal discharge, decreased menstrual blood loss ectopia, cervical chlamydia rise in cholesterol concentration in and risk of anemia; decreased gallbladder bile, uterine fibroids menstrual pain, suppression of Progestin-associated: diabetes CONTRACEPTIVE RESEARCH AND DEVELOPMENT pain associated with ovulation related changes, hypertension, heart attacks
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From page 179... ...
Associated with increased cervical Progestin-associated: weight gain, chlamydia; not protective against depression, fatigue, headaches, viral STDs, including HIV/AIDS decreased libido, acne, increased breast size, breast tenderness, increased LDL cholesterol level, decreased HDL cholesterol level, chronic itch Male condoms Protects against bacterial and viral None known Decreased sensation during STDs, including HIV/AIDS; intercourse, allergy to latex, delays premature ejaculation; possible interference with erection enhancement; prevention erection, loss of spontaneity of sperm allergy Female condoms Protects against STDs, including None known Decreased sensation during HIV/AIDS, including on the vulva intercourse, allergy to polyurethane; aesthetically unappealing and awkward to use for some TRANSLATING UNMET NEED INTO MARKET DEMAND Barrier methods (diaphragm, Protects against bacterial STDs, Vaginal trauma, toxic shock Vaginal and urinary tract infection cervical cap, sponge) prevention against HIV/AIDS not syndrome (rare)
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From page 180... ...
Age, gender, and sexual risk behaviors for sexually transmitted diseases in the United States. IN Research Issues in Human Behavior and Sexually Transmitted Diseases in the AIDS Era.
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From page 181... ...
. A telephone poll of 1,000 American women, conducted for the Kaiser Family Foundation in 1995, found that only one-quarter of women of reproductive age are confident that oral contraceptives are "very safe" for the user; others expressed a spectrum of concern, with 43 percent considering them "somewhat safe," 18 percent "somewhat unsafe," and 11 percent "very unsafe." Six out of 10 of these women cited worries about potential health risks, while many others expressed concern that the pill does not protect against sexually transmitted diseases or that it is ineffective in preventing pregnancy.
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From page 182... ...
The IUD for women with an active, recent, or recurrent pelvic infection or for women at high risk for a sexually transmitted disease is inappropriate. The jury is still out in connection with a slight increase in breast cancer risk among younger users of oral contraceptives, even though lifetime increased risk is close to zero.
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From page 183... ...
. An example: Although combination oral contraceptives have a perfect-use pregnancy rate of 0.1 percent during the first year of use, the typical-use pregnancy rate is closer to 3 percent (Hatcher et al.
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From page 184... ...
Forty-two percent of all contraceptive use was terminated by the twelfth month after adoption, 11 percent because of contraceptive failure (unintended pregnancy) , and 11 percent for health concerns and side effects.
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From page 185... ...
As for causes of discontinuance, 1 out of 5 users of vaginal methods, periodic abstinence, and withdrawal discontinued the method before the end of the first year because of contraceptive failure; the comparable figure for the pill and injectable was 1 in 14 users (see Figure 5-4)
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From page 186... ...
. The totality of these findings is highly relevant to appraising the need for new contraceptive methods.
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From page 187... ...
However, they also discontinue or switch because the current state of the available contraceptive methods, especially of hormonal methods, is far from satisfactory. Side-effects and health concerns, [perceived or real]
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From page 188... ...
Formerly married (separated, divorced, widowed) women have the highest rates of failure in the use of reversible contraceptive methods; married women have the lowest.
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From page 189... ...
Women Typical Perfect Continuing Use Method Use Use at One Year Chance 85 85 Spermicides 21 6 43 Periodic abstinence 20 67 Calendar method 9 Ovulation method 3 Symptothermal method 2 Postovulation method 1 Withdrawal 19 4 Cap Parous women 36 26 45 Nulliparous women 18 9 58 Diaphragm 18 6 58 Condom Female (Reality®) 21 5 56 Male 12 3 63 Pill 3 72 Progestin only 0.5 Combined 0.1 IUD Progesterone T 2.0 1.5 81 Copper T 380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Depo-Provera 0.3 0.3 70 Norplant (6 capsules)
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From page 190... ...
, followed by the pill. Periodic abstinence and the male condom follow at some distance, with the poorest continuation rates for the low-efficacy, coitus-dependent vaginal methods (diaphragm, spermicides, cervical cap, sponge)
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From page 191... ...
. In considering the primary problems reported for the major contraceptive methods in the Demographic and Health Surveys, 19 percent of the problems reported for sterilization had to do with health concerns, compared to 42 percent for the pill and 35 percent for the IUD (Bongaarts and Bruce 1995)
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From page 192... ...
1991) .10 Prevalence of Sexually Transmitted Disease, Including HIV/AIDS There already seems to be a rather loud demand signal in the market "asking" for an industry response to the mounting risk of sexually transmitted disease (STD)
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From page 193... ...
A very recent worldwide study by the World Health Organization's Global Programme on AIDS, done in collaboration with the Rockefeller Foundation, discovered the following sobering facts. Sexually Transmitted Disease Worldwide At least 333 million new cases of curable sexually transmitted diseases were predicted to occur in the world in 1995.
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From page 194... ...
SOURCE: World Health Organization. An Overview of Selected Curable Sexually Transmitted Diseases (WHO/GPA/STD/95.1)
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From page 195... ...
. Sexually Transmitted Disease in the United States For the four diseases analyzed by the WHO, the U.S.
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From page 196... ...
. The latter is also true in the United States, where provider-client exchanges concerning reproductive choice are sometimes glaringly inadequate and contraceptive users may get much of their information from the media, often incorrectly (Institute of Medicine 1995; Moore et al.
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From page 197... ...
The WHO/HRP review observes that users differ so markedly from one another in their criteria for selection of a contraceptive method that even people choosing a more or less similar product may be dissimilar in the relative importance they attach to the specific attributes of the product chosen. For instance, the IUD is chosen by women in India, Turkey, and the Republic of Korea primarily for its perceived effectiveness, but for its ease of use by postpartum women in the Philippines.
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From page 198... ...
There have been precise statements about specific technologies that are wanted which are so eminently desirable that they should be construed by industry as virtual instructions. These have become a core element of the "Contraception 21" Initiative launched by the Rockefeller Foundation and have come to be known as the "woman-centered agenda." As explained in Chapter 1, that agenda awards priority to the following contraceptive technologies: • vaginal methods that protect against sexually transmitted reproductive tract infections, both in conjunction with contraception and independent from it; • menses-inducers; and • more methods for men.
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From page 199... ...
. Finally, the observation is made that the frontier area of mucosal immunity might eventually offer simultaneous protection against unintended pregnancy and infection (see Appendix D)
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From page 200... ...
Even were no female "vaccine" to result from that research, worthy advances might have been made toward methods for men and toward vaginal methods which might be protective against conception and sexually transmitted infection. Regular review of the status of progress in these areas, as well as in the broader field of relevant immunologic research, could nourish the dialogue that has been initiated between concerned women's groups and scientific researchers, and perhaps shift investment out of areas that appear to be less productive in terms of the needs of women and their potential for the market.
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From page 201... ...
However, the sharp decline in Norplant use which began in 1993 and the role of injectables were not accounted for in those projections, so that percentages can be expected to shift, although at this point unpredictably. Of the remaining market balance, condom sales account for about half and are growing, apparently in response to heightened concern about sexually transmitted diseases, including HIV.
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From page 202... ...
Between 1989 and 1994, sales by U.S contraceptives manufacturers grew at an average of 4 percent a year, with sales of oral contraceptives growing at the
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From page 203... ...
Second, the market has demonstrated that it will respond to at least some public health needs when the consumer population signals a demand for such a response. The case in point is the effect on the market of concerns about sexually transmitted disease, as different kinds of populations became aware of that public health need and the possibility of dual method use.
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From page 204... ...
Oral Contraceptives Condoms Diaphragms Year U.S.$ % U.S.$ % U.S.$ % 1989 960.8 84.1 115.4 10.1 3.4 0.3 1990 989.3 83.8 122.8 10.1 3.5 0.3 1991 1,016.5 81.1 131.6 10.5 3.8 0.3 1992 1,041.5 80.5 138.4 10.7 3.9 0.3 1993 1,065.6 79.9 146.7 11.0 4.0 0.3 1994 1,087.7 79.2 155.2 11.3 4.1 0.3 1995 1,107.6 78.4 165.3 11.7 4.2 0.3 1996 1,127.1 77.6 174.3 12.9 4.4 0.3 1997 1,146.2 76.9 183.5 12.3 6.0 0.4 1998 1,161.2 75.8 193.0 12.6 6.1 0.4 1999 1,175.6 74.8 204.3 13.0 6.3 0.4 aCumulative annual gross earnings. developing economies is substantially less than that of the contraceptive market in the industrial economies, even though the latter represents a much smaller number of consumers.
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From page 205... ...
A survey of developing countries in the 1980s found that, first, the role of the private sector diminished as use of government-provided sterilization grew and, second, that this decrease occurred at the expense of private-sector sales of reversible methods (Cross et al.
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From page 206... ...
In the developing economies, private-sector prices may be lower and, more critically, national public sectors or overseas development assistance agencies subsidize large contraceptive procurements for low-cost or free distribution. These distributions are made primarily through governments, which presently supply about 86 percent of all modern methods used in developing countries -- 95 percent of the clinical methods of sterilization and IUDs, 57 percent of pills, and 47 percent of condoms.
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From page 207... ...
IN Contraceptive Research and Development 1984–1994: The Road from Mexico City to Cairo and Beyond. PFA Van Look, G PérezPalacios, eds.
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From page 208... ...
.18 Even though the vaccine and contraceptives market are not fully analogous, there are enough similarities so that some of the conclusions of the Mercer analysis may be illuminating. Similarities and Differences Between Vaccines and Contraceptives The world vaccine market, until recently valued at around $2 billion, has been reestimated by Mercer at close to $3 billion.
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From page 209... ...
that they will invest in new products. The public sector is also willing to invest; for instance, the U.S.
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From page 210... ...
UNICEF procurement is based on a strong tiered pricing system in which other customers, including industrial-country governments, pay a price for a given product that covers all production and overhead costs, provides research and development funds for new vaccines, and generates a reasonable return. Mercer finds this pricing structure to be a positive incentive to the market and beneficial to all parties, but notes that such positive effect requires continual reinforcement, in the form of improved country forecasting; more precise targeting of supply to countries most in need; sustained public-sector knowledge about the economic and technical issues faced by suppliers; ongoing, collaborative public/privatesector evaluation of procurement strategy; and evaluation of manufacturers not only on price but on supply security, R&D capacity, and access to new products (Mercer Management Consulting 1994)
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From page 211... ...
for the manufacture of contraceptives. The Fund's reading of the current situation is that because contraceptive prevalence rates are increasing in most countries, because the absolute number of couples of reproductive age keeps growing, and because population groups such as single persons and adolescents are increasingly in need of contraceptive services, the commodity volumes required by individual countries can only rise.
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From page 212... ...
, considerably more than the current market share for these regions. UNFPA has estimated that in 1994 governments, including multilateral and bilateral donors, would provide 75 percent of all modern contraceptive methods, albeit with widely varying proportions in the commodities supplied, a total cost to governments of $398 million.
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From page 213... ...
At present, direct donor subsidies account for about 25 percent of public-sector participation in the provision of contraceptive commodities to developing economies. This is smaller than the UNICEF participation in the vaccine market but it is not inconsequential.
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From page 214... ...
214 TABLE 5-12 Estimated Sources of Supply of Modern Methods of Contraception in Developing Countries, by Method and by Region, 1994 (in %) Source Modern Sterilization Pill Injectable IUD Condom Total Government 86.3 95.0 56.7 66.8 94.4 47.1 Private 13.7 5.0 43.3 33.2 5.6 52.9 Pharmacy 4.1 0.0 32.7 5.8 0.2 40.7 NGO 0.6 0.5 0.8 0.5 0.5 0.4 Other 9.1 4.5 9.8 26.9 5.0 11.8 Sub-Saharan Africa Government 65.0 53.2 67.4 81.3 62.9 35.5 Private 35.0 46.8 32.6 18.7 37.1 64.5 Pharmacy 4.3 0.0 7.1 0.3 0.0 18.6 NGO 3.2 0.6 3.4 2.0 5.5 3.4 Other 27.4 46.3 22.1 16.4 31.6 42.5 Arab States and Europe Government 42.5 82.3 32.6 47.9 49.8 22.2 Private 57.5 17.7 67.4 52.1 50.2 77.8 Pharmacy 31.6 0.0 62.3 6.8 2.7 72.9 NGO 0.7 0.0 0.9 2.7 0.9 0.1 Other 25.2 17.7 4.2 42.5 46.6 4.8 CONTRACEPTIVE RESEARCH AND DEVELOPMENT
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From page 216... ...
The Cost-Effectiveness of Contraception in the United States Table 5-13 presents a summary of costs of the major conditions against which contraception is in some way protective, the costs per relevant intervention, and estimated savings. It includes sexually transmitted diseases, since those are transmissible through the same process as conception, and since a method that could provide simultaneous protection against both conception and infection is very high on the list of women's priorities for new technologies.
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From page 217... ...
, which have especially powerful impact on constrained state-level health budgets. However, the methods that are most cost-effective in terms of preventing pregnancy do not reduce the risk of sexually transmitted infection, although oral contraceptives, implants, and injectables do reduce risk for pelvic inflammatory disease.
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From page 218... ...
– mutual intercourse w/o contra- 20,000 fewer LBWs ception, method 106,900 fewer births w/ failures, and rapes no or late prenatal care Emergency Managed care: 53/100 women ECP: $142 in managed contraception $59 for ECP, $392 treated with ECPs; care setting, $54 in (I) c for copper-T IUD; 71/100 women public-sector setting; public-sector setting: treated w/ postcoital Copper-T IUD: $123 in $35 for ECP, $172 insertion of managed care setting, $53 for copper-T IUD copper-T IUD in public-sector setting (plus cost savings from 10 yrs.
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From page 219... ...
$340–$415 million net savings over 2 yrs. for nation as a whole TRANSLATING UNMET NEED INTO MARKET DEMAND STDs: Chlamydia/ Over $5 billion/yr.
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From page 220... ...
after use stops NOTES: UIP = unintended pregnancy; UWP = unwanted pregnancy; ECP = emergency contraceptive pills (ordinary birth control pills containing estrogen and progestin, administered immediately after unprotected intercourse and up to 72 hours beyond, per regimen) ; LBW = low birth weight.
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From page 221... ...
Fact Sheet: The Cost-Effectiveness of Family Planning and Reproductive Health Care.
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From page 222... ...
$14,500 Five-Year Savings Achieved Over No Method Copper-T IUD Vasectomy 13,500 Implant Injectable Oral Contraceptives 12,500 Progesterone-T IUD Male Condom Tubal Ligation 11,500 Withdrawal Periodic Abstinence Diaphragm 10,500 Spermicides Female Condom 9,500 Sponge or Cervical Cap 8,500 2.7 3.2 3.7 4.2 4.7 Number of Unintended Pregnancies Avoided Over 5 Years FIGURE 5-8b Cost savings and pregnancies avoided over 5 years for contraceptive methods compared with no method, managed payment model. SOURCE (Figures 5-8a and 5-8b)
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From page 223... ...
. The Costs of Sexually Transmitted Reproductive Tract Infections As discussed earlier in this report, the burden of the sexually transmitted diseases in the developing world is enormous, as are its social and economic consequences.
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From page 224... ...
However, these calculations may be to some extent artifactual: First, the FDA allows only latex and plastic male condoms and the polyurethane female condom to be marketed as prophylactics against STDs and, second, the relatively small impact of STD costs on total savings from use of contraceptive methods really derives from the low incidence of sexually transmitted diseases when all women of reproductive age are considered as a group. Were the same analysis to be focused on those age cohorts among whom incidence of STDs is highest, that is, just the younger cohorts, the savings impacts would be much greater (Trussell et al.
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From page 225... ...
. Paying for Contraception The savings that can be realized from contraception are of such magnitude that it is hard to understand why they appear to be so unappreciated by virtually all providers of health insurance coverage.
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From page 226... ...
Coverage of oral contraceptives is much higher in POS networks and HMOs. Only 7 percent of HMOs provide no contraceptive coverage at all, and 39 percent cover all five methods (Guttmacher Institute 1995c)
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From page 227... ...
At the same time, the costs of providing those services, including costs of contraceptive commodities, have risen; for example, the average price for oral contraceptives to publicly funded family planning clinics rose 42 percent in just one year, between 1991 and 1992 (Daley and Gold 1993)
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From page 228... ...
SOURCE: Alan Guttmacher Institute. Uneven and Unequal: Insurance Coverage and Reproductive Health Services.
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From page 229... ...
Uneven and Unequal: Insurance Coverage and Reproductive Health Services. New York: The Alan Guttmacher Institute.
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From page 230... ...
Testing Positive: Sexually Transmitted Diseases and the Public Health Response. New York: The Alan Guttmacher Institute.
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From page 231... ...
American women's sexual behavior and exposure to risk of sexually transmitted diseases. Family Planning Perspectives 24:244–254, 1992.
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From page 232... ...
Unintended pregnancies and use, misuse, and discontinuation of oral contraceptives. Journal of Reproductive Medicine 40(5)
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From page 233... ...
. An Overview of Selected Curable Sexually Transmitted Dis eases.
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From page 234... ...
are high-dose oral contraceptives known for approximately 20 years to be effective in preventing pregnancy if taken within 72 hours after unprotected sex. Nausea and vomiting are common side effects and contraindications for oral contraceptives (OCs)
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From page 235... ...
16. MWRA, or "married women of reproductive age." 17.
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