Birth Control Makers Weary of Controversy : Liability Problems Limit Contraceptive Choices as Drug Firms Leave the Field

The last thing Alza Corp. ever wanted was a monopoly.

When G. D. Searle & Co. withdrew its intrauterine device from the market in January, 1986, Alza became, by default, the last drug company in America to sell an IUD.

Immediately, the Palo Alto company narrowed the focus of its marketing, suspended most of its research in the contraceptive area, raised the price of its product, and began to insist that all potential users of its “Progestasert” IUD read and sign an eight-page informed-consent agreement.

“The thing we want to avoid--more than anything else--is a dramatic increase in the sale of this product,” said Peter Carpenter, chairman of the firm’s strategic planning committee. “That means new people and more problems.”

Popularity Dilemma

Last year, Alza sold 60,000 of its IUDs at $84 a unit. Analysts say the company could easily sell 20 times that number.

By the standards of the pharmaceutical industry, Alza’s reluctance to market its Progestasert contraceptive aggressively is hardly unusual. By the beginning of this summer, Alza’s IUD will be joined by another manufactured by GynoPharma Inc., a small start-up drug manufacturer in Somerville, N.J.

But by and large, concerns over low profits, product liability and unfavorable public opinion have led pharmaceutical houses either to scale back their contraceptive research programs or leave the field altogether.

Syntex Corp., the California firm that rose to prominence in the 1960s on the strength of the birth control pill, has no current research program on oral contraception.

A. H. Robins Co. stopped marketing its Dalkon Shield IUD years ago after the product turned into a medical disaster. Upjohn Co. shut down its fertility labs in 1985. Twenty years after contraception became one of the hotter topics in the industry, only Ortho Pharmaceutical Corp.--a division of Johnson & Johnson--and a handful of smaller firms are left.

The situation has raised concern among some health experts, who say that significant groups within the U.S. population are now without satisfactory forms of contraception.

“This country has been without a copper IUD for the past two and a half years. We’re the only country in the world without it,” said Roderick L. MacKenzie, chairman of GynoPharma.

He also noted that there are injectable contraceptives “available in virtually every country in the world except here. There are new, lower-dose and probably safer oral contraceptives on the market in Europe, with no sign that they will ever come to market in the United States.”

“We like to pride ourselves in most fields as being the most technologically advanced country in the world,” added Alza’s Carpenter. “Yet the American woman--to say nothing of the American male--has fewer contraceptive alternatives than people in practically any other country in the world.”

Industry observers predict that over the next few years, as the medical research revolution continues in virtually every other field, the contraceptive lag in the United States will only get worse.

At present, with the exception of research conducted by Johnson & Johnson’s Ortho, responsibility for the development of new forms of contraception is almost entirely in the hands of nonprofit, government funded research institutions, which haven’t nearly the research and development resources of private firms.

“It is quite possible that pharmaceutical companies, with their large stores of chemicals, might have found entirely new leads to contraception if they had continued research,” said Harold Nash, senior scientist at the Population Council, a New York-based nonprofit research group. “Public sector organizations don’t have access to those kind of chemicals, or the facilities for screening.”

While major drug companies routinely spend $60 million to $100 million bringing a new drug to market, for instance, the total budgets of the three most important publicly funded research groups--the Population Council, North Carolina’s Family Health International, and Norfolk’s Contraceptive Research and Development Program (CONRAD)--is $16 million a year.

As a result, their work largely consists of tinkering with dosage levels or delivery systems of known, safe chemical structures. Some of the developments to come from the nonprofits are considered valuable, such as disposable diaphragms and special contraceptive skin implants. But few are revolutionary.

“We can’t sustain the level of scientific activity and basic research that’s necessary to have a continuous flow of new products and drugs,” said Roberto Rivera, director of clinical trials for Family Health International, a North Carolina group funded by the Agency for International Development. “That is the most serious effect of the lack of industry research.”

At the heart of the problem, say many within the drug industry, is concern over product liability--an issue that has loomed large since the disastrous conduct of the A. H. Robins Co. over the Dalkon Shield IUD.

For years, the industry has argued that contraception is so politically and socially sensitive--and so prone to litigation--that liability relief is necessary for research to continue. The industry has argued that the threat of huge lawsuits has made what is an otherwise profitable market unattractive.

“In order to ensure the likelihood of additional choices in the future, a balance has to be made between holding companies responsible for transgressions and not punishing them for honest mistakes, which happen from time to time,” said Henry Gabelnick, director of CONRAD’s extramural programs and product development.

The product liability bill now under consideration in Congress would offer drug companies--among other manufacturers--a broad range of legal protections against liability suits. But the bill is under siege by right-to-lifers and some women’s groups, who fear that the legislation goes too far in shielding drug manufacturers.

With the experience of the Dalkon Shield in mind, they are pushing for all contraceptives to be excluded from the bill’s protections.

Even if the bill does pass, however, it is not clear that it would bring drug companies running back to birth control.

Some of the contraceptives under development, for example, are actually considered to be safer--and thereby pose a smaller liability risk--than other contraceptives currently on the market. Yet researchers report that pharmaceutical companies are still reluctant to market them. “I was at a meeting where we were considering new types of condoms using materials stronger than latex,” said Gabelnick of CONRAD. “But there was a major chemical company there, and they wouldn’t even look at it.”

“I’ve looked at the books,” said GynoPharma’s MacKenzie. “People have not been driven out of this business by financial reasons.

“It’s simply that the companies working in this field have become exhausted by the continuous stream of . . . adverse publicity in the press. They’ve decided to direct their marketing efforts and research dollars toward areas that don’t result in such negative publicity.”

For example, the odds are slim that the French “morning-after” pill RU-486--which terminates pregnancy up to six weeks after conception--will ever be marketed in the United States, partly as a result of the drug’s potential side effects but also because of a boycott threat by right-to-life groups.

Still, for those firms remaining in the contraceptive market, avoiding the cloud of product liability remains the biggest challenge.