Contraceptives for the 21st century.

Contraceptives for the 21st Century

The recent approval of Norplant as the first change in contraceptive technology in twenty years provides an appropriate occasion to examine current developments and trends in contraception.

The desire to limit fertility goes back thousands of years, with the earliest known formulas for the prevention of conception coming to us in the Petri Papyrus, written in ancient Egypt about 1950 B.C. How are American couples today trying to prevent conception? Here are the methods they employ:

* Sterilization: 35%

* Pill: 28%

* Condoms: 13%

* No method: 10%

* Diaphragms: 5%

* Withdrawal, "rhythm

method": 4%

* IUD: 2%

A recent United States National Academy of Sciences meeting concluded that "new or improved contraceptives are needed to offer couples a wider range of options for safer, effective and acceptable methods of family planning."

The US has one of the highest rates of unintended pregnancy in the Western world. Each year more than three million women have unwanted pregnancies and half have abortions.

A committee of the National Research Council has concluded that fear of lawsuits has kept American drug companies from developing better birth control technology. As a result, an estimated 750,000 women have abortions each year because the contraceptives they or their partners used did not work. A further evidence of the need for better contraception, the committee pointed to the fact that one third of the Americans who practice birth control resort to sterilization, a method described by the committee as "drastic and often irreversible." One can assume that many choose sterilization out of the sheer frustration at the fallibility/questionable safety of the means available.

The American public wants and needs sure, safe means of birth control. But what are American researchers and the American government doing to address this need? The National Academy of Sciences reported that the United States has fallen decades behind Europe in the development of contraceptives. The decline in research was blamed on lawsuits against the makers of birth control devices and drugs, political fights over abortion, federal drug approval policies and lack of government financing. Until 1980, seventeen major US companies were carrying on contraceptive development, but now only one company is doing so.

The title of a recent article, "Fear of Lawsuits Causes Lag in Research," implies that if women were more docile and weren't suing companies over devices such as the Dalkon shield IUD, the state of the art would be more advanced. Does the forward march of research abroad indicate truly better designs and research, or a more passive population, unsophisticated in litigation?

Instead of rising to the challenge of producing better contraceptives, American companies are slithering away and doing nothing. It is ironic that the "rigors" of federal drug approval policies are holding up new developments in birth control, when it is clear that the stop-and-go decisions of the FDA are based on motives far from consumer demand, safety, and effectiveness. Why do women's groups sometimes have to fight for testing of hormonal methods of birth control which drastically alter a woman's physical and psychological well-being, while approval of barrier devices like the cervical cap was held up for ten years despite decades of use in Europe with almost no side effects?

Another element which adds to the quagmire of contraceptive development in the US is the moral haze surrounding the issues of contraception as well as abortion. The peculiarly American vestiges of prudery and puritanism color the entire discussion of family planning and birth control with a hue of indecency and sin. Legislators can continue to denounce sex education classes in public schools, accessibility of birth control devices and information to young people and so on, because pregnancy and children can be seen as the appropriate "punishment" for "indulgence" in sex. Yet the rights and obligations of the family to provide values and moral direction are not being fulfilled, and we are left with the skyrocketing crisis in teen pregnancy, abortion and pregnancies which families do not feel able to support financially.

The Population Crisis Committee's study "Access to Affordable Contraception" found that the United States has some of the highest contraceptive costs among industrialized countries. The high cost of birth control is another contributing factor to unwanted pregnancies and abortions, says the committee's director.

The report recommends that the cost of birth control not be more than one percent of average per capita income. In six countries of the world, is exceeds 25 percent. For example, an average woman in Chad would have to pay nearly three-fourths of a year's income for an intrauterine device. Even condoms are priced out of reach for couples in 59 countries, the study reports.

Those of us in "middle class America" are fairly isolated from the problems of poor women, for whom medicaid pays for only three months worth of birth control pills postpartum, and annual exams and other methods of birth control are not reimbursable. We are safely insulated in this country from the grave problems women in developing countries have in securing birth control or not becoming part of the maternal mortality statistics when they do give birth.

The scope of the problem is massive. In this issue, we have chosen only to explore some of those developments which are likely to directly impact American women, now and in the near future. The following summary, as well as the more detailed articles which follow on various new developments, have been culled from the international press (see "Viewpoint" for addresses of major publications).

The Women's Health Journal summarized current trends in contraceptive research as follows:

Implants and Injectables for Women--Norplant involves the insertion of progestins under the skin of the upper arm, is effective for 1-5 years and is removable; side effects include irregular menstrual bleeding. Progestin is also being given in one- two- and three-month injections in many parts of the world.

Vaginal Delivery of Hormones--vaginal rings are being investigated which deliver the same hormones as oral contraceptives. They are self-inserted; one type is worn for 3 weeks and removed for 1 week while another type is worn continuously for 3 months. Irregular bleeding has been reported, but fewer side effects than with oral contraceptives.

Intrauterine Devices--new devices being tested include one which releases Levonorgestrel and has less menstrual blood loss than with other IUDs and another that is designed to be used postpartum, when the uterus is more susceptible to perforation.

Barrier Methods--new synthetic male and female condoms are being developed; spermicidal or antiviral lubricants could be added.

Vaccines--a vaccine against hCG (a pregnancy-maintaining hormone) is given followed by boosters every 1-2 years; effectiveness is under investigation; there have been no apparent side effects in the first year of WHO clinical study.

Pills, Implants, and Injectables for Males--the Gossypol pill is taken daily for 3 months followed by a pill 2-3 times a week. It has resulted in neuromuscular disorders and some cases of irreversibility. The LHRH analog is currently under investigation as an injectable with potential for being an implant.

Ovulation Predicting Methods--technology is improving for predicting ovulation through self-inserted oral or vaginal sensors.

Post-Coital Methods--RU486 is taken orally for 1-3 days after intercourse together with prostaglandin tablets, injections or vaginal suppositories. It is reported 95% effective in the first 8 weeks of pregnancy but has encountered resistance as a form of pregnancy termination.

Male Sterilization--A "no-scalpel method" involves only a puncture wound, and the "Shug" method involves the insertion of a silicone plug into the vas deferens using a hypodermic needle. This latter method has the possibility for reversal; its effectiveness is still under investigation.

Sources for this article were Women's Health Journal, No 18, April-May-June 1990; figures from the Alan Guttmacher Institute, reported in the Ann Arbor News, April 13, 1991; Cox News Service as reported in Midwifery Today, No. 15, 1990; BIRTH 17:4, December 1990, p. 230; "For most, birth control is too costly," from the Ann Arbor News, July 1, 1991.