“Pregnant” would not be the word to describe the present state of contraceptive research and development in this country. We’re way behind in devising new birth-control methods and in marketing those already available in other parts of the world, according to a report released last Valentine’s Day by the National Academy of Sciences (NAS).

“Since the introduction of the pill and the IUD in the early 1960s, no fundamentally new contraceptive methods have been approved for use in the United States,” notes the report, “Developing New Contraceptives: Obstacles and Opportunities.” Only one major U.S. drug company, Ortho Pharmaceutical, is presently engaged in ongoing contraceptive research, and few universities are focusing on the problem.

With all of the fuss in recent years over abortion, it may seem surprising that contraception research has taken a backseat. But a number of political and economic factors have discouraged it. Gordon Perkin, a physician and member of the NAS committee that issued the report, says the dearth of contraception research and development reflects manufacturers’ fears of product-liability lawsuits, the strength of antiabortion politics, the restrictive policies of the Food and Drug Administration, and the lack of government and foundation support. The members of the NAS committee–an international group of 16 physicians, academics, and other experts in family planning–hope their report will increase funding for research and fundamentally change current U.S. policy on contraception.

Perkin, who is also the president of a nonprofit organization that counsels various third-world nations on health and family-planning issues, has an international view of birth control. “We have fewer choices of contraceptive methods than people in many other countries, including China,” he says with a certain amazement.

In Finland, Sweden, and ten other countries, couples regularly use contraceptive implants such as the highly effective Norplant, a long-acting (three to five years) hormone-secreting device that’s implanted under the skin of a woman’s upper arm. Depo-Provera, which is injected every three months, was developed in the U.S. but never passed FDA muster; it is used today in 90 countries. Multiload IUDs, which secrete hormones, are used by a large minority of European IUD users; the manufacturer has declined to introduce it in the U.S. because of the high cost of liability insurance. In the Netherlands women can be sterilized with Ovablock silicone plugs, which increase the chance of reversibility if the user wants that. In England and Canada women can have their fallopian tubes closed with Filshie clips made of rubber-lined titanium, which are less damaging to the tubes and make reversal more likely.

But Perkin also understands that the United States is unique in its proclivity for public debate. “Collectively, China has the largest choice of contraceptive methods available in any country. But there’s not much public outcry, about either what they do have or what they don’t.”

In trying to understand how the U.S. arrived at its impasse, Perkin and his NAS colleagues looked not only at technological advances and legal issues, but also at the deeply held religious beliefs and moral values that have had a conscious or unconscious influence on American attitudes toward contraception. Most Americans are not opposed to birth control, on religious or any other grounds: 95 percent of women between the ages of 15 and 44 who have had intercourse have used contraceptives, and 70 percent of married American women of child-bearing age (or their partners) use some method. A 1987 study found the pill to be the most commonly used method, followed by female sterilization, condoms, and vasectomies. According to the NAS report, “only modest differences exist in rates of practice among various economic, religious, and racial groups,” despite the continuing prohibition of birth control by some church groups. “Opposition to family planning appears to be limited to a tiny minority of Americans, almost all of whom oppose abortion, sterilization, or modern methods of contraception for religious reasons.”

Out of this tiny group comes the vocal and sometimes violent picketing of abortion clinics and family-planning centers by groups such as Operation Rescue. The American Life Lobby recently initiated what looks to be a well-planned offensive against U.S. marketing of the French abortion drug RU-486; they have called for a boycott of French wines. The new “Europill” makes abortion a private act: it’s taken by a woman in the seclusion of her home, without the intervention of a physician. “If you have a chemical abortifacient, [abortion opponents] won’t know where to go, which woman’s home to go to,” says Perkin. Yet the availability of a wider range of effective contraceptives would probably do a lot more to lower the abortion rate, by reducing the number of unwanted pregnancies, than abstaining from Bordeaux. “People who are against abortion should be actively working to promote contraceptive research to reduce the number of unwanted pregnancies. It’s what you have to do. The logic of that is so compelling.”

Abortion is linked to contraception in other ways, according to the report. Studies in other countries have shown that, “If abortion is safe, legal, and readily available, a woman might choose a safer but less effective contraceptive method. Conversely, if abortion is not readily available, a woman might select a more efficacious but also riskier contraceptive. One recent study indicates that as many as half of all unwanted pregnancies resulting in abortion were the result of contraceptive failure.”

The more effective birth-control methods include the IUD, which is inserted and then forgotten (barring complications) by the user, implants, and injections, which have the similar advantage of not requiring the user to do something before every act of intercourse. Diaphragms, condoms, low-dose oral contraceptives, and spermicides have fewer side effects, but demand more vigilance. Of course, many of those who oppose both abortion and contraception, on the theory that any interference in the reproductive process is morally unacceptable, would not favor a lower abortion rate if it resulted from increased use of birth-control devices.

There’s no question that the when-does-life-begin conundrums posed by the religious right put obstacles in the way of contraceptive research. But FDA policy is no less of a barrier. “The way it is now in the U.S., a contraceptive is just approved, with no specific indications for its use,” says Perkin. “Everyone and anyone could use it. If the FDA would limit approval for specific indications, it would be possible to consider things not now available here.”

Perkin cites one commonly used long-term device, the contraceptive implant, which releases tiny amounts of steroids when it is placed under the skin. Though implants have been studied for more than 20 years and are currently used in 17 countries, they have not been approved in the U.S. This is in part the result of the FDA’s tendency, Perkin says, to “treat contraceptives generically, as either safe for everyone or unsafe for everyone.” He and the NAS committee favor an approach that would approve some alternative contraceptive methods “if it can be shown that the new contraceptive also offers a safety advantage for an identifiable group of users.”

The populations whose reproductive-health needs are not now well served include men, breast-feeding mothers, teenagers, and women over 40. Older women, breast-feeding mothers, and teens would all be better served by long-term reversible implants or by some of the new oral-contraceptive formulations already available in Europe (which contain about a hundredth of the amount of steroid the pills sold in the 1960s contained).

If the FDA were to go to a specific-indication method of approval (which is already used for other types of drugs, such as beta blockers), the NAS report claims there would be a “healthier match of method to user.” The report also notes that while the FDA has been criticized for not being stringent enough in its safety requirements, many nonscientists don’t understand the meaning of “safety” in the context of FDA approval. It is “scientifically incorrect,” according to the report, to assume that “the safety of a drug can be conclusively determined before it is approved. The clinical testing of a drug in a few thousand human subjects ordinarily can identify the drug’s relatively common side effects, but it cannot identify the relatively uncommon effects.”

Perkin believes safety studies should focus on a balance of health risks to benefits. “There are groups in the population for whom the risks of pregnancy are greater, for whom it could seriously affect their health or life. But the risks to them of taking currently available methods are unacceptable, or else they are inappropriate for them to use. Another method might have a better risk-benefit ratio.”

The committee also urges the FDA to consider convenience of use in approving contraceptives. The average person would be more likely to use an easy method consistently, and therefore would be less vulnerable to method failure. Many pregnancies that result in abortion occur not because contraceptives are avoided, but because the contraceptive is not used consistently, or else fails to work.

Contraceptive R & D by major pharmaceutical companies is also hampered by product-liability laws and the increasing cost of liability insurance. Companies are discouraged from embarking on an expensive, long-term development process, Perkin claims, when they know in advance they’ll have to sell the product at a high price to cover insurance costs. “For example, IUDs sell in this country for around $100. The U.S. government buys the same devices for third-world distribution [through international health programs] for $1 or less each. So a significant part of the fee a doctor pays for the device [and charges the woman] goes to liability insurance for the company that manufactured the device. That’s made the [contraceptive field] unattractive to many companies.” Understandably so.

The problem of commercial viability also applies to products such as the cervical cap, even if they have not been the subject of costly lawsuits. “The cervical cap, which is produced by a small manufacturer, is not attractive to large companies because it’s reusable,” says Perkin. “Any product that you can reuse–where you don’t have to get a new supply of pills every month, for example–is very unattractive commercially, because you’re not going to make many sales. You sell one cap to a customer, and that’s it for maybe five years.”

The Copper-T IUD, one of only two types now available in this country, further illustrates the dilemma of the drug companies. “The Copper-T represents a very advanced and improved form of contraception. But it was approved by the FDA, and not a single company chose to market it for almost three years. It’s now marketed by a small company in New Jersey [GynoPharma Inc.] that markets only contraceptive devices. If it were any other drug, an antidepressant, or something for hypertension or gastric conditions, they would have been tripping over each other to get to it.”

One thing that might make such products more attractive to marketers is a change in product-liability laws to include what the NAS committee calls the “FDA defense.” Their report states, “Although manufacturers may introduce evidence of compliance with FDA regulations in a contraceptive products-liability lawsuit, this evidence is given no special status in most states, such as entitling a manufacturer to a presumption that it acted with due care. Given that a system of pre-marketing review exists, the necessity for liability as a quality-control mechanism is greatly reduced.” While advocating such changes in product-liability laws, the committee also recognizes that in some circumstances FDA approval would not negate a manufacturer’s liability, especially if information about the adverse effects of a device or drug were withheld from the FDA by the maker. Perkin says, “Another recommendation of the committee was that liability be modified so that people injured through the use of a contraceptive would recover costs only, like no-fault insurance. They’d be compensated, but not beyond a certain point.”

Perkin also points out that government and private-foundation support for basic reproductive research has not grown substantially in the past 20 years. The report states, “Federal funds for contraceptive development have remained virtually unchanged [in constant dollars] over the last decade, while pharmaceutical-industry and private-foundation support for contraceptive development has diminished.” One possible solution to this lag in R & D, says Perkin, is for Congress to establish a series of contraception research centers at universities around the country, thus stimulating private foundations and drug companies to contribute to major long-term research efforts.

A recent study by the Alan Guttmacher Institute (AGI) points to another advantage in government support for family planning. According to the study, nearly one in every four women who use contraceptives (not including sterilization) gets them from publicly subsidized sources. If these 4.5 million women were not using birth control, 1.2 million additional unintended pregnancies would occur each year. AGI calculates that for every public dollar spent on family planning, $4.40 is saved in medical care, welfare, and social services. “In addition,” the study notes, “although only a small number of women at risk of unintended pregnancy use no method of contraception, about 8 percent of these women account for over half of all unintended pregnancies and half of all abortions.” Increases in public support for contraception, therefore, would have obvious money-saving benefits, to say nothing of the social advantages for the women involved.

Not a single one of these factors–antiabortion politics, FDA rules, product-liability laws, or funding shortages–is by itself a deterrent to the further development of birth-control devices and drugs. But together their effect has been stultifying. “Under the current climate in this country,” says Perkin, “a number of the methods we now have–the diaphragm, the pill–would not be available if they were just being introduced.” Which just goes to show that even one of the most advanced nations in the world, technologically speaking, is still a developing country in the way it views some social problems. Perhaps the time has come for Americans to depoliticize the personal when it comes to contraceptives, and give men and women the choices already available to millions of others worldwide.

Art accompanying story in printed newspaper (not available in this archive): illustration/Tony Griff.