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Redirecting Contraceptive Research
by Judy Norsigian
The following is testimony presented on behalf of the National Women’s Health Network, at the March 8, 1978, Hearings on Contraceptive Research before the Select Committee on Population of the U.S. House of Representatives.
First, as you may know, contraceptive research at present focuses heavily on hormones, drugs and invasive devices, such as hormone-releasing IUDs, prostaglandins, injectable progestogens, silastic hormonal skin implants and antipregnancy 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 no 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 IUDs might well be classified as unjustifiably hazardous in light of the extensive and increasing documentation of Pill and IUD risks. This latter point is further corroborated by hundreds of letters sent to those of us who coauthored 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 spent worldwide on contraceptive research outside of the drug industry, only $50,000 was spent on barrier method research.1 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.2
With respect to the question of who does research, I 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 noncompliance 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.3 It should be expanded and should receive further support from both public and private sources.
Male Policy Makers
Our third area of concern is policy-making. Private organizations like the Population Council, Ford Foundation, the Rockefeller 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 Interagency 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:
- Development of male contraceptive methods and techniques, including studies of combinations of known drugs and new delivery systems.
- Synthesis of new chemical agents for the regulation of female and male fertility.
- Expanded screening capabilities as well as accelerated assessment of new and old chemical entities.
- Critical biological assessment of biodegradable drug delivery systems.
- Investigation of new methods for reversible and permanent sterilization of both males and females.
- Development of a long acting female contraceptive method.
- Increased research on intrauterine devices.
- Support of clinical studies required by FDA to expedite the availability of new methods.
- Assessment of the mode of action of postovulatory contraceptives.
- Development of technology for the detection of ovulation and utilization of such technology for family-planning purposes.
These recommendations were submitted by the ICPR Committee, composed of 17 men and one woman. We doubt if a committee composed primarily of women — consumers 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 of 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, and that women are the ones who bear the major consequences of childbirth, as well as the risks and serious complications of birth control, women should have a major voice in determining which contraceptive research priorities will best meet their needs
Currently, the National Women’s Health Network (NWHN) is conducting a nation-wide survey of over 100 women’s health centers and women’s health education groups to establish what women’s health organizations see as their contraceptive research priorities. When complete, this study will be a first-of-its-kind, revealing what kind of research women want and expect the government to fund.
The Network is particularly concerned that the whole issue of contraceptive research be viewed in the context of the rising incidence of sterilization abuse. The widespread absence of safe and effective birth-control methods and the promotion of newer, more hazardous contraceptives, coupled with the withdrawal of abortion services, especially for poorer women, has forced more and more people, both men and women, to submit to sterilization as the solution to fertility control. At this time, we urge a moratorium on all funding for new experiments with new sterilization methods and recommend further investigation into the consequences of current methods of sterilization.
The medical establishment, including government and private organizations, universities, and industrial supply corporations, presently promote research which emphasizes patents, profits, and the development of new technologies. The NWHN recommends a shifting of priorities so that safer contraceptives, for both men and women, can be developed and marketed in a timely manner. Towards this end the NWHN would be pleased to work with members of this Committee on the development of specific recommendations to Congress.
Following are some questions submitted to Ms. Norsigian following her testimony, along with her responses.
You state that over 80% of the federally funded contraceptive research projects are conducted by males. Do you know for a fact whether or not large numbers of women actually applied (or apply) for such research grants and did (do) not get them? In addition, you state that these investigators are people who “will never have to use the methods that they develop.” Isn’t there a fair amount of work being done, and I assume that it is being done by men, in the area of reproductive biology of and contraception for men?
No, I do not know for a fact whether or not large numbers of women applied for research grants. I would guess not, as they now represent a fairly small percentage of all researchers. I refer you to Personnel Needs and Training for Biomedical and Behavioral Research, 1977 report of the National Research Council (NAS): see chapter 8, “Minorities and Women” (including information in the Appendix). This report notes that women in the biomedical and behavioral sciences are likely to encounter greater problems in the utilization of their training than men.
In 1976 in particular, there was considerable funding in the area of male contraception. However, the majority of research, especially now, is still focussed on women. I am not sure that this is inappropriate, since women are the ones who ultimately become pregnant and give birth. I do think that far more women must be involved in the research process.
In your testimony you emphasize that current research “focuses heavily on hormones, drugs, and invasive devices, such as hormone-releasing IUDs, prostaglandins, injectable progestogens, silastic hormonal skin implants and anti pregnancy vaccines.” While it is perhaps understandable that pharmaceutical companies would so direct their research efforts, you also note that only a small fraction of the funds spent worldwide on contraceptive research outside of the drug industry have been devoted to barrier method research. How do you explain this strong general bias towards drug research?
There are probably a number of reasons for the bias towards drug and invasive device research. In the scientific community one tends to gain prestige by developing more sophisticated and technologically complex solutions. There is no glamour in pursuing more effective barrier methods, which do not, by and large, draw from the “exciting” recent advances in basic biomedical research. Unfortunately, the research which represents the most interesting scientific challenge does not necessarily produce the most socially useful results.
Yesterday witnesses were asked to suggest an appropriate balance of priorities between hormonal and nonhormonal contraceptive research, considering the increasing concern about risks associated with hormonal methods. One opinion was that, as long as a majority of women are using these methods, the research efforts should continue to focus on development of hormonal technologies. Could you please comment?
Women are using hormonal methods primarily because they are encouraged to do so. Please note the comments of Robert Hatcher, MD, in the article, “Update on Birth Control” (Modern Bride, April/May, 1978), as well as remarks made by other physicians. We could just as well focus our efforts on less risky methods. At the very least, we could put equal resources into further development of barrier methods and into their more effective use.
Upjohn, Depo-Provera and the Third World
The National Women’s Health Network, representing both women’s health groups and individual consumers and providers from across the country, has been protesting efforts of the Upjohn Company to seek FDA approval of Depo-Provera as a contraceptive. Use of this injectable contraceptive, a known carcinogen associated with serious risks and harmful side effects, represents a major threat to the health and well-being of women, and possibly to their offspring as well.
Many serious side effects of the drug Depo-Provera are well-known including the fact that Depo-Provera has in the past:
1) Been shown to cause malignant breast tumors in beagle dog studies,
2) Shown evidence of increasing the risk of cervical cancer in women who use it,
3) Been shown to increase the incidence of irregular bleeding disturbances. necessitating the administration of estrogen to control the bleeding,
4) Been associated with a risk of congenital malformations in humans exposed to the drug during pregnancy,
5) Been shown to cause long-term infertility and possible permanent sterility in many women after they have ceased taking the drug, and
6) Been linked to numerous other undesirable side effects such as weight gain, acne, hair loss, severe mental depression, etc.. as shown in over 125 affidavits from women who have received the drug for contraception in the Los Angeles area.
To date. the long-term safety of Depo-Provera has not been established, and yet, according to Philip Corfman, Director of the Center for Population Research, it is estimated that “3 to 5 million women presently use this drug as a contraceptive worldwide.” This represents another massive experiment like those of the Pill and DES. which have caused severe and unnecessary damage to thousands of women.
Furthermore, in some countries, lactating mothers have been urged to use Depo-Provera despite the fact that infants may suffer from the ingestion of Depo-Provera in breast milk. Promotional material for this drug distributed by Upjohn in parts of Africa is particularly irresponsible in this respect: One brochure recently sent to the Network depicts a mother breastfeeding her child, along with the caption: “Now, when she most desires dependable contraception.”
As the following remarks of the chairperson of the National Council of Women of Kenya indicate, women in Africa are concerned about the widespread and indiscriminate use of Depo-Provera:
We are told that few women in developed nations are on the injection — ( Depo- Provera), yet we have evidence that this method is now being used almost indiscriminately in our country. Claims of strict control by the Ministry of Health appear very questionable. What control does the Ministry have over Private Doctors who advise large numbers of women?
We need urgently and sincerely to ask ourselves whether we would jeopardise the health of our nation in our effort to control ‘the population explosion. It is crucial that we establish our own research and even encourage direct and independent research into the whole area of Family Planning, as to long-term effects of modern Family Planning methods. We must never become the dumping ground for any half-baked methodologies and drugs which the originators (for reasons well known to themselves) are unwilling to administer to their own people.
( — Kenya Woman, V. 1. No. 6, 1978)
On behalf of women in both the United States and other countries the Network has been urging the FDA to maintain its current position on Depo-Provera, that is, to reject Upjohn’s new request for FDA approval of Depo-Provera as an injectable contraceptive (via an appeals mechanism). The Network also urges other individuals and groups to write to Donald Kennedy, Commissioner of the FDA, to make their views known. Anyone wishing further information on this should contact the Network. c/o Judy Norsigian, Boston Women’s Health Book Collective, Box 192, West Somerville, MA 02144, Or: The Institute for the Study of Medical Ethics, Box 17307, Los Angeles, CA 90017.
Judy Norsigian is a member of the Boston Women’s Health Book Collective and co-author of Our Bodies. Ourselves, as well as a member of the board of directors of the National Women’s Health Network.
- From a fact sheet prepared by the staff of the Population Council (1978).
- 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.
- For further discussion of this, see “Emergent Modes of Utilization: Gynecological Self-Help,” by Sheryl 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).