Contraception R&D; Falls Out of Favor : Of U.S. Firms, Only Ortho Continues Researching New Methods
Fearful of lawsuits, troubled by attacks from interest groups and worried about the bottom line, all but one major American drug company have stopped large-scale research into new kinds of contraception, a trend that many experts say is leaving women and men with limited choices in birth control.
Among the large firms, only Ortho Pharmaceutical Corp. of Raritan, N.J., maintains an in-depth research program into new contraceptive technologies, compared to eight major corporations in the early 1970s, according to data provided by the Allen Guttmacher Institute, a research organization in New York.
“It’s already made a difference,” said Dr. Wayne Bardin, vice president of the Population Council, a Manhattan-based nonprofit research group. “There are already incredibly fewer products in the pipeline.”
Ortho is working on easier, longer-lasting ways to deliver hormones like those now contained in birth control pills--through nasal delivery, injections, patches and other methods, according to Rich Salem, a spokesman for the Johnson & Johnson subsidiary.
“Not only have we not abandoned the area, but we have a very aggressive research and development program to discover and produce new contraceptive products,” Salem said.
But despite the efforts of Ortho, the public sector and perhaps a dozen small firms, most observers say research and new types of contraceptives coming into the market have dropped off in the United States.
“We can spend money developing products, but eventually to make the products available to the public, we have to entice manufacturers to do so,” said Dr. Henry Gabelnick, director of extramural programs and product development of the Eastern Virginia Medical School’s Contraceptive Research and Development program.
“It ends up with things that have reached a certain point and are ready to be tested more widely sitting on the shelf,” said Gabelnick, whose program is funded entirely by the U.S. Agency for International Development.
Family planning advocates say the dearth of research limits the options for both men and women who are dissatisfied with current birth control choices.
Half of women are not happy with their current method of birth control, Bardin said. That discontent is in part because of side-effects that accompany oral contraceptives and relatively high failure rates among diaphragms, IUDs, condoms and other methods.
“There’s no contraceptive that’s satisfactory for everybody, and so you find some women who aren’t served satisfactorily by any of them,” Bardin said.
Simpler Methods Needed
The effects of the research cuts are seen in high relief among women and men who choose surgical sterilization as a method of birth control, often for lack of a better option, according to Bardin.
Sterilization is the most widely used form of birth control among women aged 15-44 who are sexually active, use contraception and are not trying to become pregnant, according to figures provided by the Alan Guttmacher Institute. In 1987, one third of those women--or 13.8 million--were either sterilized themselves or had sexual partners who had been sterilized.
Yet, according to a 1982 survey, 10% of U.S. couples protected by vasectomy or tubal ligation said they would now want to undo the procedure if surgical reversal were completely safe.
“There’s a concern about the early age at which sterilization is accepted,” Bardin said.
Simpler, more durable methods of birth control would be particularly useful for teen-agers, who often use no contraception at all. About 96 out of 1,000 teen-aged girls in the United States get pregnant each year, according to Dr. Louise Tyrer, vice president for medical affairs at the Planned Parenthood Federation of America.
“They’re the group that really needs to be reached with contraception,” Tyrer said, adding that available types of birth control are just one factor explaining the high pregnancy rate.
In addition, most current birth control devices and drugs focus on women, instead of men who might benefit from injectable hormones or other long-lasting technologies. “We need better methods for women, but I think even more importantly they need some reasonably modern methods for men,” said Dr. Philip Corfman, supervisory medical officer for fertility and maternal health drugs at the Food and Drug Administration.
The major drug companies give a number of reasons for pulling out of contraceptive research programs.
G. D. Searle & Co. of Skokie, Ill., pulled its IUDs off the shelves in 1986 but continues to manufacture birth control pills. The firm dropped its IUD line largely because of what the company considered unwarranted lawsuits that followed the uproar over A. H. Robbins’ Dalkon Shield. “It is not conducive to making you think of developing new things in an area where there is so much interest in litigation,” said Kay Bruno, Searle’s senior director of public affairs.
Syntex Corp., based in Palo Alto, Calif., is another manufacturer of oral contraceptives that no longer does extensive research in birth control technologies. “It’s more a matter of looking at how well is the oral contraceptive population served,” said spokeswoman Linda Thomas, who added that the company feels women are well-served by existing products.
A number of American companies say they can rely on new technologies licensed from European firms, while U.S. corporations concentrate on cardiovascular and other drugs. “There’s no need to duplicate it here,” said Marshall E. Malloy, manager of media relations for Warner-Lambert Co. of Morris Plains, N.J.
But other observers find more complex reasons for the shift away from contraceptive research.
Roderick Mackenzie, former president of Ortho and current chairman of GynoPharma Inc. of Somerville, N.J., which recently introduced a new IUD, said the root of the problem is scientific. He argued that the important developments in birth control technology came from a few major scientific breakthroughs. The first was the invention of the IUD; the second was the discovery of inexpensive ways to manufacture hormones used in the pill, and, third, the realization that copper enhances IUD performance.
With the exception of RU-486, the so-called abortion pill recently introduced in France, there has been no other major innovation to guide companies’ basic research efforts, Mackenzie said. “When you’re funding research, you have to have a plan for where it might take you.”
Huge Damage Awards
As the companies lost their sense of direction, they put basic research funds into other fields, creating a “vicious circle,” Mackenzie said. Even Ortho, he added, does less research than it did 10 years ago, although the company spokesman Salem said Ortho remains committed to female medicine.
Complicating the scientific problems in contraceptive research were legal and social troubles that discouraged active laboratory work.
The Dalkon Shield, which drove Richmond, Va.-based A. H. Robbins out of business, made pharmaceutical and insurance companies wary of the huge damages awarded in drug liability cases. “The reason the major companies have pulled out is quite simple: dollars,” said Gabelnick of CONRAD. “They are afraid to take the risks because of the giant lawsuits that have come up.”
Even producers of safe products found themselves fearful of litigation, a situation that clashed with the drug companies’ desire to be seen as providers of good health.