Birth Control: Scared To A Standstill

Most drugmakers dread the legal risks, so older methods still prevail

In the world of modern contraceptives, the Persona system is a high-tech throwback. Developed by UniPath, a unit of Unilever PLC, it's an electronic device that lets couples practicing the rhythm method know when it's safe to have sex. There's a green light for safe days, a red light when a pregnancy is likely, and a yellow light when the $75 device is unsure. On those days, the woman uses a dipstick urine test to determine her hormone levels. It's a perfect method for the '90s--free of drugs and implants, high on personal responsibility and abstinence.

Unfortunately, the UniPath device--tests on which start in the U.S. this month--is too complicated to use and too expensive to be the solution for the hundreds of millions of women worldwide trying to avoid pregnancy. The two top choices are still sterilization and birth-control pills--methods that have been available for 25 years or more.

The contraceptive market should be a drug company's dream: A growing global population that is seeking new options. According to a report from the U.S. Institute of Medicine in 1996, 60% of all pregnancies are unintended--and half of those occur when couples use contraceptives.

FRACTURED. But instead of grabbing this market, pharmaceutical companies practice active avoidance. They cite the high risk of liability and concerns that the contraceptive market, though estimated at $3.3 billion, is too fractured to ensure big profits. "The threat of harassment and liability litigation is the straw that breaks the camel's back," says Gloria Feldt, executive director of the Planned Parenthood Federation of America. For example, Norplant, the ill-fated hormonal implant, saw its sales drop from $141 million in 1993--its first full year on the market--to $3.7 million last year (table) as the result of litigation and bad press.

Women complained of side effects, and the implant proved tougher to remove than expected. Tens of thousands sued Wyeth and its suppliers, many now charging that Norplant's silicone tubing causes the same problems experienced by women with breast implants. In February, a federal judge in Texas threw out five suits. The problem of removal is being solved, and many doctors believe Norplant is safe and effective. But the Norplant experience in the U.S., says Sandra P. Arnold, vice-president for corporate affairs at the Population Council, which developed the implant, "encourages companies to be very cautious."

The result is that the U.S. has fewer contraceptive options than most other developed nations. And European companies are doing the bulk of new research. Only two U.S. companies--Johnson & Johnson's Ortho-McNeill unit and American Home Products' Wyeth-Ayerst--are doing any substantial work in the area, mostly in new pill formulations.

It has even been hard to get companies to market contraceptives in the U.S. that are available overseas. One example is an intrauterine device (IUD) developed by the Population Council. Sold in Europe by the Germany company Schering, it releases hormones and is effective for five years. Another option available outside the U.S. is a one-month version of the injectable hormone Depo-Provera. The three-month version, sold in the U.S. by Pharmacia & Upjohn Inc., took 10 years to get approval in the U.S., where it is not widely used.

Beyond current products, companies also shun promising new methods. The Institute of Medicine report identified three key areas for more research: a joint spermicide-microbicide that would protect women against HIV and other sexually transmitted diseases; male contraceptives; and a once-a-month contraceptive pill. The Rockefeller Foundation is trying to hook up companies with researchers in these areas--looking for 50% funding at an early level. The idea is to benefit from companies' business sense. "I feel like this is the last best hope," says Steven Sinding, director for population sciences at the foundation.

MOTIVATING MEN. So far, Ortho is interested in the microbicide--but not a spermicide. Separately, the Population Council and the National Institute of Child Health & Human Development (NICHD) are working on the dual method. According to Diana Blithe, an NICHD biochemist, researchers have already identified a number of promising agents and hope to begin clinical trials in a year. But they have attracted no partners.

Male contraceptives have been tougher to develop because hormones that interfere with sperm production also interfere with a man's sex drive. Another worry is that men aren't motivated enough to use new methods. "The key is to find a male contraceptive that, taken from the age of 19, prevents male-pattern baldness," jokes Population Council President Margaret Catley-Carlson. The Rockefeller Foundation has recruited Schering as a partner in this area. Instead of blocking testosterone, their idea is to hamper the movement of sperm after they leave the testes.

University researchers--and some at Merck & Co.--are working on so-called immunocontraception as another option for males--or females. It involves finding antigens specific to sperm or eggs that can be targeted with antibodies. In one scenario, antibodies could interfere with a hormone that might help a sperm mature. The effect would be reversible.

The final area that the Institute of Medicine singled out for attention: a once-a-month pill that might prevent a fertilized egg from implanting in the uterine wall. This group includes the "morning-after pill." Essentially a larger- dose birth-control pill, it was recommended by the Food & Drug Administration last year. But because it's associated with abortion, there has been little interest. "We firmly support the need for this product," says Audrey Ashby, a spokesperson for Wyeth, "but we see product liability as a significant barrier."

Gynetics in Somerville, N.J., is the only U.S. company pursuing emergency contraceptives. Its founder, Rod MacKenzie, is no stranger to controversy: He formed the company that commercialized the copper-T IUD in the U.S. His company was bought by Ortho in 1995, and the IUD is now sold as ParaGard.

For the next decade or so, experts say, there will be no new revolutionary contraceptives. As companies hunker down--fearful of controversy and

liability--an unmet market lies waiting.

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