TIME: Almanac 1993/TIME Almanac 1993.iso/time/122490/1224350.000

Text File | 1992-08-28 | 6.5 KB | 137 lines

                                                                                MEDICINE, Page 66

A Pill That Gets Under the Skin


Norplant could spur birth control -- and stir controversy

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 AmeriHome 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.


____________________________________________________________
FIVE YEARS OF PROTECTION


    In the procedure, six matchstick-size flexible tubes are
inserted under the skin in a fan-shaped pattern. The tubes
contain a synthetic hormone called progestin, which is released
at a slow, even rate. The drug prevents pregnancy through a
combination of mechanisms. It inhibits ovulation, so that eggs
are released regularly, and it thickens cervical mucus,
preventing sperm from reaching the eggs that are produced.