A Pill That Gets Under the Skin

By ANDREW PURVIS

For a country in which medical breakthroughs occur with dizzying regularity, the U.S. has been disturbingly backward in the field of contraception research. Not a single fundamentally new birth-control method has been introduced since the Pill and the IUD, or intrauterine device, came out in the early 1960s. Meanwhile, in several European countries, a series of contraceptive innovations has broadened the range of methods far beyond what is available in the U.S. -- and sharply reduced the number of unwanted pregnancies.

Thus many American health experts were delighted last week when the Food and Drug Administration finally approved Norplant, a long-lasting contraceptive that is implanted under the skin. Already available in 16 other countries, the method not only is highly effective but also provides five years of protection against pregnancy with a single implant. How American women will respond to this new alternative, though, is not clear, since Norplant's long-term safety has yet to be fully studied, and it does have a few side effects. Some critics fear that the five-year implant will be used by policymakers as a way of forcing contraception on women deemed unfit for motherhood.

Norplant is essentially an old contraceptive in a new package. Developed by the Population Council, an international nonprofit research group, and Wyeth- Ayerst Laboratories, a division of American Home Products Corp. of Philadelphia, the method prevents pregnancy by using the hormone progestin, which with estrogen is the active ingredient in most birth-control pills. Norplant consists of six progestin-filled silicone tubes, each about the size of a matchstick. In a simple 15-minute procedure, a doctor inserts the tubes just beneath the skin in a woman's upper arm. Once in place, the tiny cylinders start releasing progestin into the bloodstream. The flow continues until the hormone is depleted -- usually in about five years. If a woman wishes to become pregnant earlier, she can have the tubes removed, and fertility will be restored in less than 48 hours. In clinical trials Norplant was remarkably effective. During the first two years the implant had one-tenth to one-twentieth the failure rate of oral contraceptives, which fail 3% of the time. Surveys of women who have used Norplant -- a total of 350,000 worldwide -- show that 80% are willing to stick with the contraceptive for at least one year.

The method does have drawbacks. Progestin causes irregular menstrual bleeding in 75% of women who use it. Women may get their periods at odd intervals, such as 3 or 7 weeks apart, and some could miss one altogether. The periods themselves can also be longer, an average of 8 days of bleeding or spotting as opposed to the normal 5 days. These effects diminish after the first two years, according to the manufacturers. In addition, the cost, although less than that of oral contraceptives, will be considerable. Wyeth- Ayerst officials will not reveal the price until marketing begins in February, but some experts have estimated that the implant and the medical procedure together will run to about $500, as opposed to an average of $900 for five years of the Pill.

Norplant's biggest advantage over other contraceptives is that it requires only one birth-control decision every five years. The method will be useful to young women who want to delay their first pregnancy and to older women who want a reversible alternative to sterilization, which is now the most common method of contraception in the U.S.

But the same advantages that recommend Norplant to many women also raise the specter of abuse. Some health experts fear that legislators and judges will try to use the method as a way of restricting the reproductive freedom of teenagers, drug users, convicted child abusers or even the mentally ill. Economist Isabel Sawhill at the Urban Institute, a Washington-based research organization, recently published a paper in which she suggested that all teenagers be encouraged to use Norplant at puberty. "The decision to have a child would become a conscious choice -- decoupled from the dictates of biology, hormones and peer pressure," she wrote.

Sawhill is not recommending the use of force, but some experts believe that coercion is an inevitable next step. Arthur Caplan, director of the Center for Biomedical Ethics at the University of Minnesota, points to a handful of cases in the past five years in which judges have tried to require women to take oral contraceptives or to force men to take drugs that lessen their sexual drive. "There are judges out there who will try to use Norplant," says Caplan. Others worry that some developing countries will force the contraceptive on women without their full consent in a misguided attempt to keep population growth down.

The controversy over Norplant highlights a general dissatisfaction with the state of contraception research in the U.S. Numerous other methods are being studied around the world, including a hormone-releasing IUD, a hormonal badge that is taped to the arm and releases a contraceptive through the skin, a female condom and a hormone-emitting vaginal ring, which a woman can insert and remove at will. The French abortion pill, RU-486, is being actively considered for approval in several other European countries but has not been approved in the U.S. Thanks in part to political skittishness about funding contraception in the U.S., American women still have a paltry array of birth- control choices. Many experts see this contraceptive gap as the chief reason why 3.5 million unwanted pregnancies still occur each year in the U.S. Policymakers are a long way from stopping that national tragedy, but the approval of Norplant may be a start.