By JEANNE MALMGREN

© St. Petersburg Times, published February 9, 2000

It was a revolutionary idea that freed millions of women.

Take a tiny pill every day, and, voila, no unwanted pregnancies.

Simple. Foolproof (as long as they remembered the daily dose). Liberating.

When it was approved by the U.S. Food and Drug Administration in 1960, the birth control pill represented a huge leap in contraception. Now women could control their fertility hormonally, instead of relying on clumsy and often unreliable mechanical methods, such as diaphragms and condoms.

So, it's 40 years later. What has happened since the pill?

Great stuff, say some analysts. New methods of contraception just as groundbreaking as the pill.

“Women need more choices. They want more choices.” Andrew Kaunitz, professor of obstetrics and gynecology at the University of Florida Health Science Center/Jacksonville

Not a lot, say others. Variations on the same old theme, basically. And still no "male pill."

What's clear is this: When it comes to birth control, you can never have too many choices. In a survey last year of 2,500 women in the U.S., Europe and Japan, two out of three pill users said they don't like having to take it every day.

Statistics compiled by the Alan Guttmacher Institute, a non-profit facility that researches contraceptive trends, show that use of two tried-and-true methods -- the diaphragm and the intrauterine device -- fell to all-time lows between 1988 and 1995. As women age and, presumably, move into monogamous relationships, use of condoms and the pill falls. But the need for family planning continues.

"Women need more choices. They want more choices," said Andrew Kaunitz, professor of obstetrics and gynecology at the University of Florida Health Science Center/Jacksonville.

Kaunitz was lead investigator in a recent study of Lunelle, the newest star on the contraceptive horizon. Lunelle is an injectable contraceptive that contains both estrogen and progestin. It is similar to Depo Provera, the other hormonal birth control shot, which has been available since 1992. Lunelle, however, has fewer side effects and permits a quicker return to fertility when a woman stops using it. In Kaunitz's study, it was found to be 100 percent effective in preventing pregnancy among 700 women after one year of use.

The downside: Lunelle requires a trip to a doctor's office or clinic every 28 days to receive the shot. (Depo Provera is administered every three months.)

Still, Kaunitz and others are singing the praises of Lunelle.

"I think it will be an important new contraceptive option that's safe, convenient and very effective," he said.

Lunelle, now being considered by the FDA for approval, is expected to be available to consumers by the end of this year. The manufacturers, Pharmacia & Upjohn, hope that community health clinics will have nurses to administer the shots, perhaps leading to pharmacy chains hiring nurses to give in-store shots.

"Long-term, the company is looking at developing subcutaneous injections so that women will be able to give themselves these shots at home," Kaunitz said.

Other new forms of contraception on the way include a hormonal skin patch called Evra, vaginal rings, a new "morning-after" emergency pill and non-allergenic condoms made of polyvinylchloride.

New generations of the birth control pill include more low-dose formulations, a generic version and one that contains melatonin instead of estrogen.

Modern Birth Control a timeline Condoms • possibly used first by Egyptians 3,000 years ago; condoms made of fish and animal intestine used in 1600s in England, other early ones made of linen; rubber condoms appeared in 1840s; latex condoms introduced in 1930s. Diaphragm • invented by a German physician in 1880; available in U.S. since 1920s. The Pill • 1960 IUD • 1968; Dalkon Shield taken off market in 1974; other models remain available. Sponge • 1983; discontinued in 1995; due back in stores this summer. Cervical Cap • ancient origins; modern cap approved for use in 1988 Norplant • 1990 Depo-Provera • 1992 Female Condom • 1993 “Morning-after pill” • 1998 Lunelle • Late 2000 – Jeanne Malmgren and Times researcher Kitty Bennett

There's other good news: Remember the Today sponge, that popular foam doughnut hole that delighted women in the late '80s and early '90s? It disappeared from shelves in 1995, prompting an infamous episode of Seinfeld on which Elaine started hoarding her dwindling supply of sponges and evaluating her lovers for their "sponge-worthiness?"

The sponge will be sold again, perhaps as soon as May. A small manufacturer, Allendale Pharmaceuticals of New Jersey, bought the rights from the previous Today maker, which had a dispute with the FDA over its equipment. (The safety of the sponge itself was never in question.)

Some analysts remain unimpressed, though. They say all the new contraceptives are really nothing new, just variations of methods already available.

"The pill was groundbreaking in its time, but I don't think there has been anything that revolutionary since, nor will there be in the near future," said Susan Tew, spokeswoman for the Alan Guttmacher Institute.

Planned Parenthood, on a section of its Web site about future birth control methods, says "Most of the contraceptive products that will soon be available for women are refinements of similar products that are already on the market."

If nothing new is happening, why not?

Experts blame, first of all, liability issues. Massive lawsuits against the makers of the Norplant implant and the Dalkon shield IUD scared off many would-be developers of new contraceptives.

Funding is another problem. Planned Parenthood estimates it costs $20-million to $70-million -- and an average of 10 years -- to take a new birth control method through the research and rigorous testing required by the FDA.

As a result, some birth control devices are available in Europe and other parts of the world years before American women can get them.

According to Planned Parenthood, by the time Norplant was approved by the FDA in 1990, it had already been in use for years in 22 other countries. Same story with Depo Provera: More than 30-million women worldwide have used it since 1969, but American women gained access only in 1992.

"We focus more on risks than on benefits in this country," Tew said. "For instance, there's a new IUD, called Mirena, that's being hopefully brought to this country in the next year or two. It's already very popular in European countries. It's very effective and has less side effects such as bleeding, which you can have with the copper IUDS."

Then there's the question of a male contraceptive pill. Will it ever be a reality?

"That's a question we ask all the time," said Marilyn Anderson, director of education for Planned Parenthood of southwest and central Florida. "We're so quick to make women the gatekeepers (for birth control), the problem solvers."

Researchers contend that one of the problems is male biology. Unlike women, who have monthly cycles, men are fertile all the time, constantly producing sperm. To interfere with that process, a male contraceptive pill (or injection) would also have to suppress testosterone production.

WHO knew ? Besides the old standbys, there are several unusual birth control products. Consider: the unisex condom the panty condom vaginal contraceptive film These and other contraceptive products can be viewed and purchased on the Internet at http://www.birthcontrol.com.

In the distant future, we may see injections for one or both sexes that act as vaccines against fertility. Researchers are considering ways to use antibodies to attack egg or sperm, or gonadotropin-releasing hormones to suppress other hormones that trigger ovulation and sperm development.

Carl Djerassi, a Stanford University chemist and one of the developers of the original birth control pill, includes a chapter on future contraception in his book, The Pill, Pygmy Chimps and Degas' Horse, published in 1992.

Djerassi's outlook is pessimistic. He predicts possibly even fewer birth control choices in the future, partly because of conservative opposition to "post-coital" methods of contraception -- those that do their work after an egg has been fertilized.

"The field has become an issue rather than a neutral area of research for truly revolutionary methods of contraception," he writes. ". . . The public little realizes how sparsely stocked will be the shelves of an American contraceptive supermarket by the turn of the century."

The century he was writing about is the one we're living in right now.

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