In the three decades since scientist Gregory Pincus excitedly announced laboratory synthesis of a hormone enabling women to avoid pregnancy, contraceptive research has slowed not a bit.
At least 30 offshoots of ”the pill,” developed originally by Pincus and gynecologist John Rock, compete today on the American market. Their legacy is a mainstay of contraception in the Western world, and likely to be around for decades to come.
Tinkering in the laboratory nonetheless goes on. Despite the adequacy of all these pills and various intrauterine devices, research continues for yet more convenient means of birth control that are safe, effective and inexpensive. At least a dozen American universities are involved in the search, including three in Chicago.
”It`s doubtful a totally `ideal` contraceptive for all women ever will be devised. So everyone is developing options,” says Erwin Goldberg, a biologist at Northwestern University and chief of its research in sperm immobilization.
”Most of what is going on in infertility research involves hormonal intervention. We`re engaged in a different approach–a contraceptive vaccine,” says Goldberg.
The experimental vaccine, under development since 1970, focuses on a single protein of a sperm cell not found in any other cells in a human body. Goldberg theorized long ago that if the protein could be isolated–and he identified it as lactate dehydrogenase in 1963–and administered to a female, the antibodies she develops in response would immobilize all sperm subsequently encountered in sexual intercourse.
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The quest so far is arduous but promising. ”If things continue the way they`ve been going, I`d say we`re five years away from human trials. When you consider that we started this project in 1970, five years does not seem so long,” says Goldberg, who has successfully tested the vaccine`s sperm-stopping properties with 28 female baboons.
One major hurdle, reversibility, appears resolved. Almost all the experimental baboons got pregnant soon after injections of lactate
dehydrogenase ceased, according to Goldberg, who is aiming for a human vaccine effective for up to 10 months.
Research on other approaches to contraception and birth control goes on elsewhere, with promising results.
”Some are coming on the market by next year. Others are likely to be here by the end of the decade,” predicts Gerald Zatuchni, director of technical assistance at Northwestern University`s Program for Applied Research on Fertility Regulation (PARFR), which oversees disbursal of some $2.5 million in contraceptive research grants, mostly from the Agency for International Development and the National Institutes of Health.
What else is on the horizon? And when?
For women, there`s the following:
— A cervical ”dipstick” test. At the University of Illinois-Chicago campus, biochemist John Tsibris is experimenting with an at-home test of cervical mucus, enabling women to know with certainty the five critical days prior to ovulation to say ”no”–a device with far-reaching implications for advocates of ”natural” family planning (also known as rhythm). The test works by detecting the rapid drop of a key cervical enzyme, guaiacol peroxidase, which is known to diminish rapidly five to seven days before ovulation. Forecast: on the market in 1988.
— An injectable microscopic capsule. The capsule contains the hormone norethindrone to inhibit pregnancy and eliminates the need for a daily pill. It features a lower dosage (norethindrone has been an major ingredient in birth control pills for almost 20 years). Three time options would be available: 30, 90 and 180 days. Research is by Stolle Research Corp., Cincinnati. Clinical trials on women are underway in seven locations in Mexico and U.S. Forecast: as early as 1988, though 1990 is more likely.
— Tubal occlusion without surgery. This is female sterilization, similar in effect to tubal ligation, but takes only 15 minutes (and at considerably less cost than a tubal ligation). Occlusion works through the insertion, via a tube, of a chemical called methylcyanoacrylate (MCA) through the cervix to tubal lumens. The chemical closes the tubes by creating adhesions. It is administered by a physician in two insertions several weeks apart; it`s already on market in Canada and United Kingdom. Forecast for U.S.: 1986.
— Disposable diaphragm. There is much research in this area: PARFR is in the early stages of perfecting three types of disposable diaphragms, all over- the-counter, each embedded with spermacide. ”One size fits all,” says Northwestern`s Zatuchni. No need to see a doctor. No messy creams. No need to clean the diaphragm afterward. ”If we can retail it for a dollar, millions of women will buy it,” says Zatuchni. Forecast: 1987.
— Vaginal ring. The ring is an easily removable, doughnut-shape device that secretes the contraceptive hormone levonorgestrel. Users insert the silicon rubber ring themselves, although a nurse`s aid may help the first time. The ring may be removed every fourth week to accommodate menstruation. Side effects are characteristic of estrogens: nausea and headaches among them, but users report less frequent occurence than with the pill. Vaginal discharge occurs more frequently, according to the Population Council, a New York-based organization that researches and develops birth control devices. One variety, 20 years in development, has been tested in England, Sweden, Dominican Republic and Brazil. The device has been sidetracked temporarily in U.S. pending more clinical studies after recent studies on some rabbits and monkeys suggested unwanted long-term effects on the cardiovascular system. Forecast:
uncertain.
— A birth control injection that prevents sustained pregnancy by triggering antibodies to chorionic gonadotrophin, a hormone formed upon pregnancy. Tests are now underway with 30 sterilized women in Australia to determine optimal low dose to trigger formation of antibodies to pregnancy. The injection, which thwarts attachment of the fertilized egg to the uterine wall, was developed by Vernon Stevens, zoologist and obstetrical researcher, Ohio State University; funded by World Health Organization. No serious side effects found in baboons, which were kept infertile for 14 months with one injection. Forecast: earliest 1990.
— ”Day after” pills. French researchers at Foussel Uclaf, meanwhile, are excited about RU486, a so-called ”day after” pill that may do away with clinic abortions. The hormone triggers menses after ingestion and appears to work effectively anytime in the early weeks of first trimester of pregnancy. Testing phase promising but too early to predict long-term effects. Forecast: promising but uncertain.
— Norplant. More immediate in its implication, Norplant is a fan-shaped, five-year contraceptive implanted just beneath the skin of a woman`s inner arm. Developed by the Population Council and forecast for commercial entry in late 1987, it works by secreting levonorgestrel, thus suppressing ovulation and changing the cervical mucus to inhibit penetration of sperm.
Research on more than 20,000 women also reveals Norplant to be more effective than the pill, which currently is used by 29 percent of all Americans practicing contraception. Norplant is commercially available so far only in Finland and Sweden, but has been tested successfully in 18 other countries for 20 years.
”I personally believe Norplant will have a significant impact in both developed and developing countries,” says Dr. Forrest Greenslade, senior consultant of international programs for the Population Council.
”It clearly is an alternative for couples thinking about sterilization. And it`s more effective and convenient than the OC (oral contraceptive). Many women who cannot tolerate the pill can use Norplant because it contains no estrogen,” Greenslade says.
Research on male contraception lags, but there`s good reason, observes Dr. Louise Tyrer, obstetrician, gynecologist and vice president for medical affairs for Planned Parenthood Federation of America:
”In the first place, it is much more difficult to interfere with sperm production than ovulation. Spermatogenesis is an ongoing process involving development of millions and millions of sperm daily. Ovulation involves one egg a month.
”Moreover, every attempt so far to affect spermatogenesis interferes with male libido. That`s unexciting to both partners,” says Tyrer.
There`s also the matter of male disinterest, which persuades pharmaceutical companies to focus on the more obvious market for
contraceptives. ”Women are more motivated to use birth control. They`re the ones who get pregnant,” Tyrer says.
Research in male contraception nonetheless exists. For example:
— Gossypol, a product found in the pigment glands of cotton seed, was discovered by Chinese researchers to have a suppressing effect on sperm production. Unfortunately, initial studies also have documented unwanted side effects. Researchers foresee no major breakthroughs until the turn of the century.
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— At Rush-Presbyterian-St. Luke`s Medical Center, biochemist Lourens Zaneveld is experimenting with removable vas deferens plugs that might some day render vasectomies obsolete. ”There have been other attempts at this;
they`ve all fallen by the way. This one appears to have promise,” says Zatuchni.
— Electrically induced coagulation of vas deferens offers male sterilization in three minutes without surgery. A needle attached to an electrical unit is inserted into penile tissue by a doctor. ”Buzz in two places for 20 seconds and it`s over,” says Zatuchni. ”We`re in our fourth prototype now and continuing clinical trials.” Forecast: uncertain.
It was 30 years ago this month that Gregory Pincus announced the pill`s impending development to a conference of International Planned Parenthood.
In that brief span, Earth has almost doubled in human population (a feat that formerly required centuries). As a direct consequence, population experts observe that millions starve and millions more will follow.
Clearly, developing countries have an interest in sharing fruits of contraceptive research in the United States. Equally as clear, contend Goldberg and others, the United States needs to reexamine its priorities in contraceptive research, which results in less than $20.5 million annually to all forms of contraceptive research, but an additional $15 million to Georgetown University to study ”natural family planning” alone.
”Every sperm is sacred, but not that sacred,” says Goldberg, caustically recalling a famous lyric from a Monty Python movie.
As one researcher noted, not altogether flippantly, ”It`s not unlike the Framm oil filter commercial on TV: Pay me now, or pay me later.”