Volume 32, Number 6, November/December 2000

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Don't Downplay Market For the Hormonal Injectable

As a practicing gynecologist, I would like to offer some comments on the article Koray Tanfer and colleagues on women's use of injectables and implants [Why are U.S. women not using long-acting contraceptives? 2000, 32(4):176-183 & 191)]. Few women in the study were using depot medroxyprogesterone acetate (marketed as Depo Provera), an injectable hormonal contraceptive that provides contraceptive protection lasting three months. The authors conclude as a result that "long-acting reversible contraception has not fulfilled its promise" [page 183].

This research has many flaws, however. Only women aged 24-41 were surveyed, thus omitting a huge number of potentially sexually active women at both ends of the reproductive spectrum. Also, the interviewing was done in 1995, when more than one-third of the women surveyed said they either had never heard of Depo Provera or lacked sufficient knowledge of the method. Since the injectable (while used by millions of women worldwide for decades) was only introduced in the United States in 1993, this certainly does not allow much time for a contraceptive method to have caught on.

Another flaw is the authors' focus on amenorrhea as one of the major side effects among injectable users. This seems inappropriate: Once most women are counseled that not getting a period is normal during injectable use, they are comfortable about not having regular menses. Clearly, when they are educated about potential side effects, most women do well. Indeed, the authors cite that "fewer than 5% of users who reported side effects said they would stop using the injectable within the year" [page 179].

As a health care provider in the United States, I believe that we have an obligation to educate women on all methods of contraception. There is also a strong need to do so, with about one-half of all pregnancies in this country being unintended. While many women who become pregnant may describe themselves as "using contraceptives" when they conceived, those methods may never have made it out of the drawer (in the case of the diaphragm or the condom), they might have been defective (a condom with a hole) or they might have been used incorrectly (some missed birth control pills).

An injectable method has the advantage of not letting contraception depend on using a diaphragm or on remembering to take a pill. It also allows women who are not quite ready to decide about sterilization to postpone that decision but remain almost completely protected from pregnancy. So rather than downplaying the possibilities of injectable contraception, I would rather see the authors search for ways to better educate women about their options, while newer methods are being researched.

Mary Jane Minkin
Department of Obstetrics and Gynecology
Yale University School of Medicine
New Haven, CT

The authors reply:
Kristen Elliott and Mary Jane Minkin criticize our article for being "based on outdated and incomplete information," for doing "a disservice to American women" and for "having many flaws." We disagree.

First, the intent of the research was neither to deny that the hormonal injectable presents a viable, effective and convenient option, nor to suggest that U.S. women do not need more contraceptive choices. On the contrary, we focused on why women are not using these viable and effective contraceptive methods, when there is a clear need for more contraceptive choices. We assumed that understanding the reluctance of women to use these methods may prove to be useful in increasing these methods' use through further research, social marketing and behavioral interventions.

Moreover, while data from 1995 might be considered outdated in the year 2000, at the time this article was written, these data were the only national data available on the use and reasons for nonuse of these methods. The only other comparable data set available at the time, the National Survey of Family Growth (NSFG), has contraceptive use data but no information on why a particular method was not used. The data cited by Elliott are neither population-based nor useful for the kind of analysis that we presented. Further, the increases in both the number of new prescriptions and the market share of the injectable that are cited by Elliot are irrelevant and misleading, as they are based on provider data and use an inappropriate denominator.

Both Eliott and Minkin object to the age restriction in our sample. While our data have a restricted age range, they nonetheless cover about two-thirds of women of reproductive age. In any case, including younger (aged 15-19) and older (aged 40-44) women does not reveal higher levels of use for either the implant or the injectable.1 In fact, use of these methods is highest in the age-groups included in our study, not in the age-groups that were excluded. Hence, we believe that adding the younger and older women would not have changed our conclusions. There is no evidence other than Pharmacia's own market research to show a higher level of use among younger or older women. The number of prescriptions written or filled and the increase in market share do not necessarily reflect usage accurately, because of all-too-frequent noncompliance.

Elliot erroneously contends that "long-acting contraceptives have helped reduce the pregnancy rate among young women in the United States," citing an article that refers to unintended pregnancies only and shows no direct evidence that such a decline was even partially a result of increased use of injectables.2 What that study says is that the availability of two new highly effective contraceptives "may [emphasis added] have prevented a disproportionate number of pregnancies." Yet during the period in question, only condom use increased significantly. The decrease in the rate of unintended pregnancy is the continuation of a trend that began long before the two methods were introduced--due primarily to an overall increase in the proportion of women who practiced contraception.

Minkin sees as a flaw our focus on amenorrhea as one of the major side effects among injectable users. We referred to amenorrhea briefly [pages 177 & 179] as being among the side effects, but not as a major side effect. On the contrary, we state: "Women using the injectable were even more likely....to report side effects, although they were less likely to describe them as major" [emphasis added]. In hindsight, we should have placed more emphasis on irregular bleeding and amenorrhea, because according to Pharmacia & Upjohn, more than 5% of the 3,900 women in the clinical trial reported these adverse reactions.3 Further, Pharmacia & Upjohn, the producer of the injectable, warn that "most women...experience disruption of menstrual bleeding patterns," including heavy and continuous bleeding, and that as women continue using the injectable, fewer experience irregular bleeding but more experience amenorrhea.4

Elliott and Minkin suggest that we have an obligation to promote U.S. women's contraceptive options and to better educate women on all methods of contraception (which we also suggest in our paper). We believe, however, that the onus of such obligations falls on representatives of the pharmaceutical industry and on service providers who prescribe the products. As social scientists, we do not produce, market, prescribe or implement the use of such products; we simply report the facts.

1. Abma JC et al., Fertility, family planning, and women's health: new data from the 1995 National Survey of Family Growth, Vital and Health Statistics, Series 23, No. 19, 1997, Table 4, p. 51.

2. Henshaw SK, Unintended pregnancy in the United States, Family Planning Perspectives, 1998, 30(1):24-29.

3. Physicians' Desk Reference, 53rd Edition, Montvale, NJ: Medical Economics Company, 1999.

4. Ibid., p. 2743.

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