Contraceptive Studies at Standstill, Study Finds : Health: Lawsuits deter U.S. firms, which have not developed a new product since the 1960s. Europeans have produced a number of effective devices.
Americans are suffering from a dearth of effective birth-control methods because almost all U.S. pharmaceutical companies have “fled the field” of contraceptive research and development, according to a two-year National Academy of Sciences study released on Wednesday.
The 153-page report, prepared by 16 experts from the academy’s National Research Council and its Institute of Medicine, said the United States needs to reduce the exposure of contraceptive manufacturers to product-liability lawsuits.
Although most contraceptives have side effects that hurt a small portion of their users, the study said those risks should be weighed against the more subtle, but greater, problems created by withholding more effective forms of birth control from society.
Those problems include unwanted pregnancies, particularly among teen-agers and older women, as well as abortions and voluntary sterilizations that could be avoided if more reliable methods of birth control were available, the study said.
“Despite a potential market of more than a half-billion people worldwide, the outlook for new contraceptive development under the current regulatory and legal climate in the United States is bleak,” Dr. Luigi Mastroianni Jr., chairman of the academy’s research committee, said at a press conference.
New contraceptives are being developed in Europe, including once-a-month pills, reversible male and female sterilizations, and methods to block sperm production. The United States, however, has not developed a “fundamentally new” form of birth control since introduction of the pill and intrauterine devices in the early 1960s, Mastroianni said.
Europeans already have access to a wider variety of approved birth-control methods that are easier to use, work longer and fail less frequently than those available in America, he said. They include time-release contraceptives implanted under the skin, injectable contraceptives, alternative sterilization techniques, and RU-486--the so-called “morning-after” pill.
Although the Food and Drug Administration approves all contraceptives sold in the United States and the warnings that accompany them, pharmaceutical companies have no assurance that they will not be sued for unforeseen injuries, the study noted.
That potential liability has scared away all but one U.S. manufacturer from developing new means of birth control, despite a need for more and better contraceptives, the researchers said.
“The threat of litigation is an obstacle to contraceptive development,” said Mastroianni, who also is director of human reproduction at the University of Pennsylvania Medical Center. “Without a change in this legal climate, even fewer U.S. firms will allocate even fewer dollars to contraceptive development.”
The researchers called on Congress to create a product-liability shield to protect pharmaceutical companies so they can operate more freely to develop new birth-control methods.
Under the academy proposal, users who claimed they had been injured by a contraceptive would find it more difficult to collect punitive damages in court. If the contraceptive had been tested and approved by the FDA, such damages would be awarded only if the injuries were proven to have been caused by the manufacturer’s negligence.
Consumer rights advocates, however, have raised objections to a product-liability cap because it would limit a citizen’s right to sue if injured.
Carol Downer of the Federation of Feminist Women’s Health Centers in Los Angeles criticized the academy’s recommendations, which are similar to earlier proposals by the pharmaceutical industry to reform product-liability laws. “Why,” she asked, “should a woman getting contraceptives suddenly become a non-person in our legal system?”
The study suggested that product safety could be increased through stricter FDA monitoring of customer complaints and more detailed studies of the different effects and special risks of alternative forms of birth control on older women, teen-agers, smokers and breast-feeders.
Eight firms had been engaged in serious contraceptive research and development in the early 1970s, according to the study. By the 1980s, however, pharmaceutical companies “fled the field of contraceptive research and development” after being slapped with too many injury claims involving FDA-certified contraceptives, Mastroianni said.
Their fears were based in part on the public furor over the Dalkon Shield, an intrauterine device manufactured by A. H. Robins Co. from 1971 to 1974. The Shield later was found to have caused severe pelvic inflammation and other ailments in hundreds of thousands of women.
More than $2 billion in injury claims were filed against Robins, and the firm filed for bankruptcy court protection. Robins eventually was acquired by American Home Products Corp., and a $2.3-billion trust fund was created for women injured by the Shield.
The only U.S. company still aggressively developing contraceptives, Ortho Pharmaceutical Corp. of Raritan, N.J., has enjoyed success in marketing of oral contraceptives, spermicides and other birth-control devices, Mastroianni said.
In 1983, however, the Johnson & Johnson subsidiary lost a $4.75-million verdict to a Kansas woman who claimed that Ortho Novum birth-control pills gave her a rare kidney disease.
“A few more lawsuits like that, and Ortho won’t be developing more contraceptives either,” Mastroianni said.
The academy’s study links between 1.2 million and 3 million unwanted pregnancies each year in the United States to contraceptive failure. Last year, it said, those failures and resulting pregnancies accounted for about half of some 1.5 million abortions nationwide.
COMMON CONTRACEPTIVE METHODS Method: Male sterilization (vasectomy) Est. % use: 14% Accidental pregnancy in 1st yr.: .15% Disadvantages: Requires skilled medical practitioner; swelling and pain common; with microsurgical techniques can be reversed about 50% of the time. Method: Female sterilization Est. % use: 19% Accidental pregnancy in 1st yr.: .4% Disadvantages: Requires skilled practitioner; complications rare but reversability is limited, requires abdominal microsurgical procedure. Method: Estrogen-progestin oral contraceptive Est. % use: 32% Accidental pregnancy in 1st yr.: 3% Disadvantages: Inhibits lactation; failure rate increases if not taken regularly; breast tenderness, nausea, depression, headache, weight gain or loss; greater risk of developing gall bladder problems in first year of use. Method: Progestin-only oral contraceptive Est. % use: N.A. Accidental pregnancy in 1st yr.: 5% Disadvantages: Less effective, more likely to cause menstrual irregularity and vaginal bleeding. Method: Intrauterine device (IUD) Est. % use: 3% Accidental pregnancy in 1st yr.: 6% Disadvantages: Side effects include increased bleeding, cramping; pregnancy while an IUD is in place can cause septic spontaneous abortion--potentially life-threatening. Method: Condoms Est. % use: 17% Accidental pregnancy in 1st yr.: 12% Disadvantages: Do deteriorate and are ineffective when stored in too much heat, humidity or sunlight and may tear if roughly handled. Method: Diaphragms Est. % use: 4-6% Accidental pregnancy in 1st yr.: 2-23% Disadvantages: May be more prone to bladder infections; possible allergic reaction to rubber, cream or may dislodge during intercourse; requires jelly; fitting by a trained health worker; not recommended for women with poor vaginal muscle tone. Method: Contraceptive sponge Est. % use: 3% Accidental pregnancy in 1st yr.: 18% Disadvantages: Removal problems may occur; possible allergic reaction; possible risk of toxic shock reported. Method: Natural fertility (periodic abstinence) Est. % use: 4% Accidental pregnancy in 1st yr.: 20% Disadvantages: Risk of pregnancy high; requires high motivation on part of both partners. Method: Vaginal contraceptive Est. % use: 2% Accidental pregnancy in 1st yr.: 21% Disadvantages: Relatively unreliable; must be used five to 10 minutes before each act of intercourse; may irritate genitals. Source: “Developing New Contraceptives,” National Academy of Sciences.
“Use” figures are for 1988; “accidental pregnancy” figures are for 1987.
