Public Health Magazine: Winter 1995, Vol.5, No.1
Articles
Female condom production begins, even as debate continues

After federal foot-dragging over its efficacy, distribution of the female condom has finally begun. The rapid spread of AIDS among women, which the new device can help prevent, however, had a head start.

"Rather than viewing it as an important new means of increasing protected sexual behavior," said Associate Dean Cheryl Healton, Dr.P.H., "the FDA treated the female condom as if it were a potentially dangerous device--harmful because it might be slightly less effective than the male condom. The FDA has responded to the tone set early on by the Centers for Disease Control by failing to actively promote the female condom as an important addition to the fight against AIDS."

In addition to Healton, other CSPH faculty have been very involved in studies of the female condom. Erica Gollub, Dr.P.H., CSPH epidemiology adjunct assistant professor and director of epidemiology at the AIDS Activities Office of the Philadelphia Department of Health, described the launch as very effective and claimed that the manufacturer is "a savvy marketer up against a lot of resistance to female-controlled contraception." The device is being manufactured by Chartex and distributed by Wisconsin Pharmacal.

Distribution of Reality¶--the brand name for the first female condom--began last summer. By year-end, some 2.3 million female condoms had been sold or distributed through public clinics and studies. Despite the non-reusable device's relatively high retail price, about $2.50 each, most state Medicaid programs will now pay for it. Also, the manufacturer launched a major promotion in January, including advertising and educational seminars, at 50 of the largest U.S. college campuses.

Such an educational campaign is necessary to overcome the awkwardness and misuse that accompany all new forms of contraception. The intravaginal-barrier device is a loose-fitting sheath with a flexible ring at each end. The closed-end ring is for vaginal insertion, and the open-end ring covers the labia, remaining outside the vagina after insertion. Reality¶ is made of polyurethane, a stronger material than the latex used for male condoms, which partly explains the high price. It is now available over the counter at most pharmacies.

And in fact, the newness of the device has prompted several controversial studies which highlighted the need for education and counseling. The studies demonstrated the difference in pregnancy rates between typical usage versus perfect usage. Unlike typical usage data, which record all risks of pregnancy, perfect usage counts risks only when the device is being used correctly and during every act of intercourse. The only risks under perfect usage, therefore, are method failures, such as breakage.

While typical usage of the female condom for six months results in a failure rate of 12 percent, perfect usage reduces the failure rate to 2.6 percent. Also, while there seems to be a considerable difference in the typical usage failure rates between the male condom (6 months = 8 percent) and female condom (12 percent), that difference has been shown to be insignificant under perfect usage. The Food and Drug Administration (FDA), nevertheless, demanded that the manufacturer print these typical usage figures comparing the male and female condoms in Reality¶ packaging information, and banned the printing therein of the perfect usage figures.

This is much to the chagrin of the manufacturer and investigators. One study extrapolated contraception failure rates to judge efficacy for HIV/STD prevention. This study, by James Trussell, et al., concluded that compared with no protection "the risk of STD transmission would be reduced by 97 percent at each act of intercourse during which the female condom is used."

CDC remains reticent

Yet, even though almost everyone including the FDA agrees that the new device rarely fails when used properly, the battle goes on. The CDC is still promoting the male condom exclusively at a time when AIDS is spreading ever more quickly among women. In a recent New York Times article on the rapid increase of AIDS rates among women, Patricia Fleming, M.D., of the CDC's Division of HIV/AIDS, said that "women need to consistently use condoms when they're having heterosexual sex."

But, when asked by the Chronicle if she was referring to male condoms exclusively, Fleming responded, "Essentially, yes. What is available and known efficacious is the male condom. We don't have the information or data to know how effective the female condom is."

CSPH's Healton disagreed. "The relative efficacy of the male versus the female condom has yet to be subjected to systematic prospective study," Healton said. "However, evidence from the rate of pregnancy protection of perfect users of the female condom suggests that the difference between their relative efficacy is either insignificant or nonexistent."

Furthermore, many women are eager to learn how to use the female condom properly. Gollub, working with CSPH Professor Emerita, Zena Stein, M.A., M.B,. B.Ch., and Wafaa El-Sadr, M.D., of Columbia P&S; and Harlem Hospital, recently concluded a post- marketing study of 52 women from Harlem. According to the study, entitled "Short-Term Acceptability of the Female Condom to Women Living or Working in Harlem," of the 52 women, 41 were able to use the female condom; and of these, two-thirds "liked the device very much or somewhat, 20 percent were neutral, and 15 percent stated that they did not like the device." Also, some 44 percent of their male partners preferred the female condom to the male condom.

Moreover, competition with the male condom is not what the promoters of the female condom want. They start from the assumption that if more methods are available, then fewer unprotected acts will take place.

In one essay, Healton and Gollub put the contention in historical perspective. "Attention to women's health concerns has always been 'too little, too late' in this country and the response to the women's AIDS crisis has been no exception," they said. "But in the case of the female condom, which clinical studies have shown to have the potential to protect against AIDS, the government has gone beyond its usual inattention to women's health to become an obstacle to the prevention of AIDS."

Gollub is currently conducting studies on the effects of offering a full range of contraceptives, including the female condom, and on the effects of provider training. "Women have been literally dying for lack of access to the type of protection provided by the female condom," she said. "It is encouraging that women see the female condom as a viable alternative when their partners refuse to use a male condom."