The Stagnant Contraceptives Industry : Birth control: Lawsuits, red tape and the religious lobby have slowed innovations, drug firms say. The Pill remains the most trusted method.
In 1960, space exploration had just begun, the personal computer hadn’t been invented and the Pill was introduced as the most advanced form of birth control.
Today, PCs and space shots are common--and the Pill is in many respects still the most advanced form of contraception.
The reason: Liability lawsuits, government red tape and anti-abortion groups have frightened most major drug companies away from birth-control research.
Couples frustrated with available options shouldn’t give up hope, though. Small companies and not-for-profit groups recently have brought new products such as Norplant and the female condom to the $1.4-billion U.S. market for contraceptives, and their development activity continues.
“We are relying on a lot of our new methods to come from Mom-and-Pop companies,” said James Trussell, director of the office of population research at Princeton University.
Furthermore, legislation now in the U.S. Senate would limit the punitive damages companies can face from products found to be unsafe. That would encourage big companies to step up their work in contraception.
More than a dozen large pharmaceutical companies were conducting research into birth control in the 1970s. That number whittled to as few as two in the 1980s, and today just a handful of major companies are doing any material work in the field.
Though many couples are satisfied with their birth-control method, there is an endless litany of complaints about the available procedures. (There are 15 in all, counting early withdrawal and periodic abstinence.) The pill can cause weight gain, partners don’t like the inconvenience or feel of latex condoms, and removal of inserted devices can be painful.
The consequences of a lack of easier-to-use, widely accepted birth-control methods are significant: More than half of the 6.4 million pregnancies in the U.S. each year are unintended. About 1.6 million end in abortion, resulting in a heated political issue.
Lawsuits that could result in huge damage awards have been a big deterrent. There is good reason for wariness, industry executives say. The most dramatic example they cite is the Dalkon Shield, the intrauterine device that drove A.H. Robins Co. into bankruptcy in 1985.
“Women’s health care products are going off the market, or not coming on the market, because of fear and the cost of product liability litigation,” said Anita Hotchkiss, a product liability lawyer for Porzio, Bromberg & Newman in New York.
That’s why the proposed legislation is critical, supporters say. It would impose a ceiling on punitive damages of $250,000 or twice a claimant’s compensatory damages.
Some big companies with a broad range of products also fear becoming targets of a general boycott if a contraceptive attracts objections on religious grounds.
Government regulations also have crippled developments in birth control. American Home Products Corp.’s contraceptive sponge won about 2% of the market, a large-enough following to be profitable, Princeton University’s Trussell said. But when the U.S. Food and Drug Administration asked American Home to fix problems in its manufacturing plant, the company decided it wasn’t worth the investment.
The cost of sufficient testing for new products to win FDA approval in the first place is often a significant stumbling block.
For example, the agency wrestled with Upjohn Inc.’s Depo-Provera until 1992, when it approved the hormone injection that prevents pregnancy for three months at a time. The FDA was concerned about its safety, even though the product had been used by more than 15 million women for almost three decades.
In the meantime, it’s the smaller companies more willing to take a chance that are spurring much of the progress in birth-control technology. Defying the legacy of the Dalkon Shield, which left many women leery of IUDs, small, closely held GynoPharma Inc. stepped up to market a new “Copper T” IUD in the U.S. in 1988. It’s now used by more than a million American women.
“There was a vacuum,” said Roderick Mackenzie, chairman and founder of Sommerville, New Jersey-based GynoPharma.
Though they’re not recommended for women who haven’t had children, the new IUDs stay in the uterus longer, which makes them less risky than their ancestors, because the chance of infection is highest after insertion. They also aren’t recommended for women at risk of sexually transmitted diseases, which contributed to the problems caused by the Dalkon Shield.
Women using the new generation of IUDs “are the most satisfied contraceptive users,” said Dr. Ezra Davidson Jr., chairman of the department of obstetrics and gynecology at Charles R. Drew Postgraduate Medical School in Los Angeles.
Similarly, it was tiny Wisconsin Pharmacal Co. that introduced the first female condom, called “Reality” to the U.S. last summer. The Jackson, Wisconsin-based company, then better known for selling insect repellent and fish bait, went public in 1990 with the help of a group of former executives from G.D. Searle & Co., which introduced the first birth control pill in 1960.
And it was the Population Council, a New York not-for-profit international research organization, that brought Norplant to the U.S. in 1991. Norplant, a series of hormonal capsules implanted under the skin of the arm, had been tested for 20 years.
Manufactured by Finnish pharmaceutical company Leiras Oy and sold in the United States by American Home Products Corp., Norplant has grabbed headlines with lawsuits from women who have had difficulty removing the capsules, which have to be replaced every five years.
In the absence of products without any drawbacks, it’s proving tough to win converts from the Pill, which is practically foolproof when used properly. The once-a-day tablet is the method of choice for 28% of women of child-bearing age, making it the most popular form of non-surgical birth control. (About 35% of women of child-bearing age are sterilized, or their partners are.)
Manufacturers of the Pill, mainly Johnson & Johnson and American Home Products, have done little research beyond developing new formulations, Princeton’s Trussell said.
Johnson & Johnson declined to comment on its activity. A spokeswoman for American Home Products said the company was working with Norplant and other implantable methods.
