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OTI Online
Summer 1991

ARE YOU READY FOR THIS? Critiques of the new contraceptives
AFTER NORPLANT, WHAT'S NEXT?
by Jill Benderly


Q: Why is a bikini like a doughnut?

A: Because they're both new contraceptives about to come on the market.

Norplant is the first new U.S. birth control method since the cervical sponge arrived in 1983. The coercive uses of the new five-year levonorgestrol implants have been widely and well discussed. To recap: a California judge sentenced Darlene Johnson to Norplant as part of her punishment for child abuse. The Philadelphia Inquirer was forced to apologize for its editorial titled "Poverty and Norplant - Can Contraception Reduce the Underclass?" The Kansas state legislature is considering a bill that would pay welfare mothers $500 to get Norplant, plus providing the implant and annual checkups free of charge. The man who developed Norplant, Dr. Sheldon Segal, says, "We created a method to enhance reproductive freedom and people keep finding ways to use it for the opposite purpose."

As health workers learn how to insert and remove Norplant, they also get a look at the benefits and problems of this low dose progestin they are placing under the skin. It lasts five years. It's highly effective. It's a quick fix - once it's in, there's nothing further to do.

Norplant poses fewer problems and short-term risks than birth control pills because it does not contain estrogen. But its active ingredient, progestin, does cause: Menstrual changes, including heavy bleeding and spotting or no menstruation at all; headache and weight change. There is also the risk of infection where it's inserted. If there are problems, or if a woman wants to get pregnant, Norplant is a good deal harder to take out than to put in. Indeed, when Norplant was tested on women in Bangladesh in 1985, providers refused to remove the device in cases of side effects.

Last but not least, Norplant is expensive: $350 for the kit, $100-250 for insertion and $100-400 for removal. So far, Medicaid in nine states will cover the costs. "We're not going to be able to provide Norplant to all who want it. We'll have to prioritize," says Dr. Gary Stewart, medical director of Planned Parenthood of Sacramento Valley. "The best candidates are noncompliant patients."

Planned Parenthood president Faye Wattleton calls Norplant "the one bright spot" in the dismal outlook for contraception. Birth control R and D moves at a snail's pace, compared to the boom of 20 years ago. Government agencies fund 95 percent of U.S. contraceptive research. Of the drug companies, only Ortho does research. This despite women's dissatisfaction with existing methods. One study of 200 Norplant users found all but 10 percent opted for Norplant because they were unhappy with all the other methods they had tried.

WHAT'S DERAILING CONTRACEPTIVE RESEARCH?

The noisiest opponents of the search for better birth control are the by-now-notso-New Right. Under the Reagan and Bush administrations, government support for contraceptive research has dwindled, as has funding for family planning programs. Antiabortion groups have flexed their muscles, stopping RU-486, the "abortion pill," from being introduced into the U.S., although it is available in China, France and Germany. This show of force has intimidated pharmaceutical companies, which fear boycotts of their entire product lines if they are associated with new "unnatural acts" to prevent pregnancy.

Another political reason for slowdown in birth control research is sexism. "Immunology, molecular biology and endocrine disorders are honorable scientific fields; sexuality, family planning and behavior are considered tacky," says Dr. Felicia Stewart, gynecologist at the Valley Center for Women, Sacramento, CA.

MONEY CHANGES EVERYTHING

While politics is the most blatant obstacle, economics plays a big role, too. The baby boom generation has entered its 40s. Projections show the number of women of childbearing age will increase by only three percent in the next 10 years, while women over age 50 will grow by more than 30 percent. This changing market has fueled research and development in estrogen replacement therapy instead of contraception.

As the demographic curve moves up, the contraceptive experts change their prescription. Dr. Kirtly Parker Jones, medical director of Utah Planned Parenthood, enthusiastically promotes wider use of the pill in women over 40. "There's a 33 percent chance of a woman having a child in her 40s," she told the 1991 Contraceptive Technology conference.""We've been so afraid of the risks that we've been unwilling to give these women pills and IUDs. The emotional and physical risks of unwanted pregnancy are actually greater. The good news is that the Food and Drug Administration has recommended removing age as a risk-factor listed on pill-package inserts."

Parker Jones reminds clinicians that the pill has "non-contraceptive benefits" for women over 40. "Older women nearing menopause have shorter cycles with heavier bleeding. The pill can improve this, as well as reducing hot flashes and osteoporosis." In other words, she proposes to keep the artificial estrogen flowing until women are over the roller coaster of menopause. Then "the patient can discontinue contraception and enter into the dialogue with her physician regarding postmenopausal hormone therapy," she recommends.

Meanwhile, with well-off white women bearing children later in life, infertility has become the hot, "compassionate" - and more medically exciting - research topic. New reproductive technologies continue to raise ethical dilemmas: Surrogacy, fetal selection, genetic engineering.

Of course, infertility research spills over into contraceptive technology. The more we learn about what keeps a couple from getting pregnant when they want to, the more we know about what can be used to keep men and women from being fertile when they don't want to.

TESTING 1-2-3

One reason it takes more time and money to develop contraceptives today is testing. The women's health movement won stricter regulatory processes from the Food and Drug Administration (FDA) following the Dalkon shield tragedy, in which an inadequately tested IUD caused widespread pelvic inflammatory disease, sterility and as many as 36 deaths. Many in the techno establishment openly chafe at the road-blocks created by concerned consumers. Stanford researcher Dr. Carl Djerassi complained in 1969 that FDA restrictions had "a particularly devastating effect on the development of new contraceptive agents," and he still leads the chorus of the anti-regulators.

It took 16 years from the time Norplant was developed until it reached the U.S. market, although it was approved for use in Finland in 1983. While many feminists feel such caution is warranted in the case of new chemical methods, the cautions have also held up barrier methods that should have been less controversial. The cervical cap, which does not differ radically from the diaphragm, has been on the English market since the mid-1800s. But, because in 1925 Margaret Sanger's husband chose to fund a business importing diaphragms from Holland instead of caps from England, caps are still barely known in the U.S. today. Only in 1988 did the cervical cap come off the "investigational device" list and out to the U.S. general public.

Cindy Pearson, executive director of the National Women's Health Network says that because of AIDS, the FDA "got smart, changed its rules, recognized reality and made the trials easier. For the female condoms, also known as "intravaginal pouches." (I'll discuss this and other new methods later on.)

THE LONG ARM OF THE LAW

The Dalkon Shield fiasco led to more than just tougher FDA regulations. The gigantic lawsuits and settlement payouts ultimately bankrupted shield manufacturer A.H. Robins. By 1986, fears of fallout led to the removal from the U.S. market of all but two IUDs - the Progestasert, a progesterone-releasing T shaped device, and the ParaGard, a copper-wrapped T. One manufacturer, G. D. Searle, gave as its only reason the fact that liability insurance was "virtually unobtainable." Today only one percent of U.S. women who use contraception use IUDs. (However, many types of IUDs are still sold for use in the Third World, where risky drugs find their "market niche." But that's another story.)

Other suits have attempted to link hormones with cancer in offspring and spermicides with disabilities in newborns. Surely the courts are a vital arena for seeking redress against corporate greed. But sometimes I feel the ball has been taken out of our hands again, this time by lawyers' greed.

While researchers and corporate reps rail against regulatory, litigational and liability obstacles to new high-tech methods, women still express major dissatisfaction with the available options. Yet low-tech barrier method research and development is not exactly proliferating.

Loretta Ross, program director of the Black Women's Health Project, says, "Why don't they work on safer devices instead? But no, the drug companies seem to be saying, 'Till we can get U.S. women to accept whatever we hand to them without them suing us, we don't offer anything at all.'"

READING THE FUTURE

So there are lots of reasons that new ideas are stymied. But what can we expect to see coming on the market soon? What are the scientists cooking up in the lab? And when will they find a new male contraceptive?

AVAILABLE TODAY

A number of methods are being used or tested around the world. The most famous is RU 486 which could be used to bring on a delayed menstrual period.

Another method of "post coital contraception" is the morning-after pill. Ovral, a combination pill, is given within 72 hours of intercourse. Side effects are said to be less severe than with its predecessor, DES. While Ovral is not approved here for morning-after use, U.S. physicians do use it, especially for rape survivors.

Progestin, the active ingredient in Norplant, works in other forms. The progestin-only mini pill is rarely used in the U.S., but makes up eight percent of the British pill market. The mini pill seems to lower cardiovascular risks but raise the chance of ectopic pregnancy.

The most well-known progestin shot is Depo-Provera, used on four million women worldwide. Because it has been linked to cancer and sterility, women's health activists have kept Depo from being approved as a contraceptive here. "It's a U.S. political reality that it won't be passed as a contraceptive," says Dr. Gary Hogden, director of contraceptive research at Eastern Virginia Medical School. "But there's nothing illegal or unethical about using an FDA-approved drug for a different use."

Progestin is also used in the vaginal ring. A woman inserts this rubber doughnut into her vagina and it releases hormones for three months.

New methods of female sterilization attempt to improve the prospects of reversibility. The Filshie clip, made of titanium and rubber, seems to cause less damage to the fallopian tubes. Ova block silicone plugs are used in the Netherlands to close off the tubes.

A new device called Bioself should be helpful for measuring basal body temperature for natural family planning. Bioself is a hand-held computer that takes basal body temp in two minutes, records past temperatures and menstrual cycle length. Then it identifies whether it is a fertile or nonfertile day with a red or green light.

BY THE YEAR 2000

"We're looking forward to the female condom," says Cindy Pearson, for their protection against AIDS and other sexually-transmitted diseases. Three types, the Bikini Condom, the Reality Sheath and Women's Choice Condom are coming soon to your neighborhood pharmacy. All three are lubricated with spermicide. The Bikini is a tan latex G-string with a rolled up pouch that is pushed into the vagina by the penis. "Finally a condom for women to wear," gush the ads. "Bikini Condoms put a woman in control of her own body." You can wear it for two hours before intercourse "providing more spontaneity than a male condom." That is, if you don't mind getting your clitoral stimulation through a rubber panty.

The Reality has two rings, one at the cervix and one outside the vagina, and a polyurethane sheath connecting them. It is inserted like a diaphragm. Women's Choice is similar, but made of latex and inserted like a tampon.

Spin offs of barrier methods in the works include disposable diaphragms and cervical caps as well as plastic condoms. The glanscap is a mini condom that fits over the glans of the penis and sticks with adhesive. It can be put on before erection occurs. The search is on for new spermicides that kill viruses.

Contraceptive experts tout new variations on the birth control pill. With ultra low-dose pills, "I think we ought to push a lot harder," says Gary Hodgen. He also suggests quarterly pill regimens, in which the placebos which cause a woman to get her period are only taken four times a year.

Transdermal patches now used for estrogen replacement therapy could be used for contraception. Large Band-aid size patches would be worn at the base of the spine or neck and release hormones into the bloodstream through the skin. New uses of progestin are expected to bear fruit soon. Biodegradable implants (Capronor) would last 18 months and not need removal. Of course, removal also would be impossible in the case of side effects.

Microspheres containing hormone particles would be injected under the skin. They would biodegrade and work for three months.

THE LONGER RUN

"Wouldn't it be terrific if we could vaccinate a population against sperm?" asks Hodgen. Experiments in immunization against various reproductive cells are still in early lab stages. Vaccines might work for men and women.

Hopes for unisex nasal sprays and injections of GNRH, a hormone that disrupts the pituitary gland, have been delayed by clinical difficulties, including decrease in the sex drive.

Inhibin is another natural substance being explored as a contraceptive. It is thought to regulate production of follicle stimulating hormones in men.

New, potentially reversible sterilization methods are being tried for men and women. However, four times as much money goes into research on women's contraceptive methods than on men's, perhaps the only place where women get more funding than men.

Researcher Roy Greep comments that "whatever the historic reasons, the result is an imbalance in the field that is scientifically inappropriate and clinically self defeating."

Gary Hodgen is much more optimistic. "I think we are beyond the time when fertility regulation was considered the exclusive responsibility of women," he says. "I don't contend that men will ever take an equal responsibility for fertility control. But the more options we have available to them, the greater a responsibility they will be willing to take."

In the prevailing political, economic and scientific climate, the future of contraception - as always - is uncertain. The National Women's Health Network puts it succinctly: "If Norplant proves to be widely acceptable to a broad range of users, as its distributors hope, it may spur other private or nonprofit companies to make a stronger commitment in the area of contraceptive research. Unless that commitment is made, Norplant may be the last new method for quite some time."


M. Robbyn Swan is a Washington, DC based freelance writer and advocate for the homeless.

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