Judy Norsigian, a member of the National Women's Health Network (NWHN) USA and of the Boston Women's Health Book Collective, and one of the authors of OUR BODIES, OURSELVES gave the following testimony on contraceptive research before the USA Congress House Select Committee on Population in March 1978.

There are three basic issues we would like to address:

   1. What kind of contraceptive research receives priority.

   2. Who carries out that research.

   3. Who makes policy decisions in the area of contraceptive research.

First, as you may know, contraceptive research at present focuses heavily on hormones, drugs, and invasive devices, such as hormone-releasing lUDs, prostaglandins, injectable progestogens, silastic hormonal skin implants, and anti-pregnancy vaccines. At the same time, there is relatively little research on safer and cheaper mechanical and barrier methods, on contraceptives which act locally rather than systemically, or on methods which require no mechanical intervention whatsoever. Examples of such safer methods include the cervical cap, diaphragm, contraceptive sponge, ovulation method, and thermal sperm control.

The safer contraceptive methods also tend not to require physician intervention, thus providing low cost, easily accessible birth control for more people. Particularly good examples are the contraceptive sponge, which requires no fitting, and the ovulation method, which requires non mechanical intervention.

Those of us active in the women's health movement are concerned that present funding is too heavily weighted toward drug and device research. Too often such research has exposed human subjects, mostly women, to serious adverse consequences. In cases where insufficient research has resulted in premature approval of contraceptive methods, much larger female populations have been exposed unnecessarily to dangers. The sequential Pill and Dalkon Shield are two well-publicized examples of this, although all Pills and lUDs might well be classified as unjustifiably hazardous in light of the extensive and increasing documentation of Pill and lUD risks. This latter point is further corroborated by hundreds of letters sent to those of us who co-authored OUR BODIES, OURSELVES. In addition, adverse consequences of contraceptive drugs and devices account for a surprisingly large number of hospital admissions, which are both expensive and traumatic for the women involved.

It is alarming to note that in 1976 out of 70 million dollars spent worldwide on contraceptive research outside of the drug industry, only $ 50,000 was spent on barrier method research (From fact sheet prepared by the staff of the Population Council, 1978). Safe birth control methods do not receive priority by those who control the research dollars, while potentially dangerous methods do attract the majority of funds. We urge a major reordering of priorities, so that research on the safer birth control methods mentioned above receive the greatest emphasis.

New priorities would also include research on better ways to communicate information about birth control methods. How well a method is understood weighs heavily on how effectively it is used. Too much emphasis has been, and continues to be, placed on the presumed passivity of women and on the desirability of methods requiring little or no active participation. Too little attention is now paid to basic body education and to those settings in which we learn best. For example, the self-help model used in many women-run health centers improves use-effectiveness of barrier methods as well as the ovulation method. Also, the intensive education model used with teenage women in some family planning clinics demonstrates that existing barrier methods, like the diaphragm, are much more effective than previously thought. (See Lane, Mary E.,et al., "Successful Use of the Diaphragm and Jelly by a Young population: Report of a Clinical Study." Family Planning Perspectives, March/April 1976).

With respect to the question of who does research, 1 call your attention to a 1976 GAO report to the Congress entitled "Federal Control of New Drug Testing Is Not Adequately Protecting Human Test Subjects and the Public". This report concludes that lack of adequate monitoring and lack of compliance with testing requirements has failed to protect thousands of human subjects from unnecessary hazards of new drugs and has failed to guarantee that test data used in deciding whether to approve new drugs for marketing is accurate and reliable. I quote from page nine, which discusses a special FDA survey completed in 1974: "Our review of the inspection results indicated that, of the 155 clinical investigators inspected, 115 (74% ) failed to comply with one or more requirements of the law and regulations." We believe that this problem of non-compliance exists in the narrower area of contraceptive drug research.

In this context it is interesting to note that most contraceptive investigators are male and hence have little direct understanding of the practical impact of their research on women. According to the inventory of population research projects listed in the NIH report. Inventory and Analysis of Federal Population Research, over 80% of federally funded investigators in the areas of contraceptive development and contraceptive evaluation during 1976 were males. It is of no small significance that these male investigators will never have to use the methods that they develop. Moreover, we believe that their focus on the biological model and their fascination and involvement in the research process sometimes .overshadows their concern for the well-being of research subjects.

In our opinion, there needs to be more research conducted by community-based women's health centers which have worked directly with those who are intended to benefit from this research.

Furthermore, subjects should play a major role in designing and/or approving the research design. We believe that such an approach would result in stricter adherence to research protocol. Research of this kind is already taking place at several women's health centers, but on a limited scale. (For further discussion of this, see "Emergent Modes of Utilization: Gynecological Self-Help", by Sheril K. Ruzek, in the Proceedings of the Conference on Women and Their Health: Research Implications of a New Era - U. of California, SF, August 1975). It should be expanded and should receive further support from both public and private sources.

Our third area of concern is policy-making. Private organizations like the Population Council, Ford Foundation, the Rockfeller Foundation, Planned Parenthood, and drug companies, as well as the federal government, sponsor practically all current contraceptive research, setting priorities for this research as well. Policy-makers for these organizations are also primarily males, who make decisions with little or no input by the many users of contraceptives, who supposedly benefit from the research. I call your attention to the composition of the Inter-agency Committee on Population Research, established in 1970, which makes federal policy recommendations regarding population research. Among the eighteen Committee members listed in the Inventory and Analysis of Federal Population Research, only one is a woman. Similarly, in the case of a private organization, only 4 women sit on the 18-member Board of Trustees of the Population Council.

An example of policy recommendations that almost totally ignore the areas of safer research we are advocating may be found on page 40 of the Inventory and Analysis of Federal Population Research:

B. Previous Recommendations on CONTRACEPTIVE DEVELOPMENT

1. Development of male contraceptive methods and techniques, including studies of combinations of known drugs and new delivery systems.
2. Synthesis of new chemical agents for the regulation of female and male fertility.
3. Expanded screening capabilities as well as accelerated assessment of new and old chemical entities.
4. Critical biological assessment of biodegradable drug delivery systems. ,
5. Investigation of new methods for reversible and permanent sterilization of both males and females.
6. Development research on intrauterine devices.
7. Support of clinical studies required by FDA to expedite the availability of new methods.
8. Assessment of the mode of action of post-ovulatory contraceptives.
9. Development of technology for the detection of ovulation and utilization of such technology for family planning

These recommendations were submitted by the ICPF Committee, composed of 17 men and one woman. We doubt if a committee composed primarily of women - consumer as well as researchers and government administrators - would have presented a similar list of recommendations.

It is our position that women should be creating policy on behalf of women, at the very least, and that all users  contraceptives should have a significant voice in determining what kind of research is funded. To the extent that birth control is still primarily the responsibility of women, are that women are the ones who bear the major consequences of childbirth, as well as the risks and serious complications birth control, women should have a major voice determining which contraceptive research priorities will best meet their needs.

Currently, NWHN is conducting a nation-wide survey of o' 100 women's health centers and women's health education groups to establish what women's health organizations see their contraceptive research priorities. When complete t study will be a first-of-its-kind, revealing what kind research women want and expect the government to fund.

The Network is particularly concerned that the whole i' of contraceptive research be viewed in the context of rising incidence of sterilization abuse. The widespread absence of safe and effective birth control methods and promotion of newer, more hazardous contraceptives, coupled with the withdrawal of abortion services, especially poorer women, has forced more and more people, ' men and women , to submit to sterilization as the solution to fertility control. At this time, we urge a moratorium all funding for new experiments with new sterilize methods and recommend further investigation into consequences of current methods of sterilization.

The medical establishment, including government private organizations, universities, and industrial supply corporations, presently promote research which emphasize patents, profits, and the development of new technologies The NWHN recommends a shifting of priorities so that safer contraceptives, for both men and women, be developed and  marketed in a timely manner. Towards this end the  NWHN would be pleased to work with members of this Committee the development of specific recommendations to Congress.