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4

Cervical Cap (continued from page 6)

cap was conducted in England and involved 16,000 women in 17 clinics. The finding was an impressive 97.6 percent effectiveness rate. (It is also interesting to note that this study did not find any correlation between pregnancy rate and social class, which should help to dispel the condescending belief that poor women are harder to educate on barrier methods.)

Many experts point to improper fit as a major factor in failures. Ruling out incorrect use and fit, however, a small number of failures do occur. This may be attributable to a finding in a 1962 Masters and Johnson study that there is some displacement of the cervix during the excitement and plateau phases of the sexual response cycle.

In light of the simple and effective nature of the cervical cap, you may wonder why the FDA has taken such a hard line. To give a brief history, a 1976 Medical Device Amendment to the Federal Food, Drug, and Cosmetic Act gave the FDA the power to classify all birth control devices and required that all newly marketed ör imported methods of birth control have current statistics to back them. Shortly after, the FDA announced that the cervical cap fell into the Class II category, the same category as the diaphragm, but only when used to collect the menses or to hold the sperm against the cervix for artificial insemination-not for purposes of birth control. Presumably, their reason was inadequate research on the cap's effectiveness and safety as a birth control device, even though the cap has been used successfully for at least 150 years without apparent side effects. Curiously, this proposal came from an FDA Advisory Panel meeting attended by representatives of six major drug companies, including Searle and Upjohn, who bring us many of the popular brands of birth control pills. As a result of the ruling, customs officials began seizing shipments of caps imported from England.

The irony of the FDA's contention that the cap was inadequately researched is evident when you look at how birth control research is conducted in this country. Most of the funding for research comes from government and private foundations and goes to academically-affiliated labs. Academicians are not likely to study so mundane and technologically simple a device as the cervical cap. A look at the 1977 government expenditures for birth control research bears this out:

$14.7 million to test the safety of oral contraceptives and to develop new oral contraceptives for women

$1.8 million to investigate new approaches based on immunology (the new oral "vaccines")

$1.5 million to develop new hormonal contraceptives for men

1

$1.0 million to test the safety of IUD's $143,000 to develop better barrier methods

Drug companies conduct a lot of their own research, but the low-profit potential of the cap makes it more of a threat than a marketable means of birth control.

+

Feminists and health activists responded to the FDA ruling by demanding that the government fund more research on the cap. A meeting attended by representatives of the FDA, the National Institute of Health (NIH), and activist groups in November of 1979 resulted in the NIH calling for funding proposals on the safety and effectiveness of the cap and diaphragm. The FDA also agreed to a moratorium on seizing shipments of cervical caps until January, 1981.

While the FDA was giving concessions with one hand, it was tightening up with the other. In February, 1980, the FDA announced that the cap was considered a Class III "Significant Risk Device" and stated that as of January 19, 1981, only those pro-

0

viders of caps who submitted and received FDA approval of a detailed plan of research would be able to continue to fit women with caps. It also provided that the packaging of all imported caps must carry the warning "for investigational use only" and ordered all shipments ceased to providers who did not have an "Investigational Device Number" (IDE) which authorized its use for research.

Not to be daunted, the National Women's Health Network decided that, if the FDA wants more research, then more research they would have-and it would be conducted by women themselves. They got together with the New Hampshire Feminist Health Center's Cervical Cap Team and sent mailings notifying all cap providers of the FDA regulations. Subsequently, the New Hampshire Feminist Health Center submitted and received approval in late 1980 for a research protocol and made the protocol available to other providers. Today there are several clinics "going by the rules", ensuring that at least a good number of women will still be able to choose the cervical cap as an option.

As of yet, there are no providers of cervical caps in this area, but if you are willing to drive the extra miles there are two clinics where you can become part of the research effort: The New Hampshire Feminist Health Center in Concord, New Hampshire (603 225-2739), and Bread and Roses Women's Health Center in Milwaukee, Wisconsin (414 2780260). You may also want to check with other feminist health clinics across the country. Some area women have made a cervical cap fitting part of their summer vacations.

There is also an interesting study under way at the Zoller Clinic, University of Chicago, by Dr. Uwe Freese, a member of the obstetrics/gynecology department, and Dr. Robert Goepp of the University's dental clinic. They have designed a custom-fitted cap (sized similarly to dental work impressions) which can be left in place indefinitely. It has a oneway valve to let discharges and menstrual fluid (continued on page 13)

Title IX (continued from page 4).

6) Arid finally, watch for loaded words that denote sexism: use of "man" for 'humankind” is outmoded. Fireman, chairman, etc. should be replaced with non-sexist designations.

As parents use these simple guidelines in assessing their children's educational environment, they become aware of their own cultural biases reguarding traditional male/female roles.

Educational institutions have always been the prime mode of training boys and girls for male and female roles in our culture. The schools, reflection of society at large, 'prepare boys to be the future wage earners, to be competitive and aggressive, to learn math and science or take vocational courses in which they learn speciali skills. The girls have traditionally been steered toward a passive and supportive role in preparation for their expected. function homemakers.

1

as

These traditional roles are no longer applicable.. Women must be prepared to work for most of their lives, out of economic necessity if not out of role expectation. If women are to be proportionately represented in the higher paying jobs, their training begins in the cradle. If the schools do not shift from the traditional view of male/female roles, the next generation of female workers will find themselves still beyond the pale.

Parent power is a viable force in changing educa• tional institutions. If a given school district is dragging its heels in implementing the regulations of Title IX, the hand that rocked that little girl's cradle had better be out there rocking the boat!

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