HEALTH : Updating Birth Control : Choosing the Method That Best Suits Your Health and Life Style

Someday, foolproof contraception may be as simple as a shot in the arm. Testosterone injections for men and an anti-sperm vaccine for women are among dozens of contraceptive techniques working their way through research labs.

But someday is both a magical and maddening word for scientists and manufacturers who know that taking a birth control method from the laboratory to the market can be even more excruciating than the usual drug-approval process.

Getting a drug on the market generally takes seven to 10 years, according to the Pharmaceutical Manufacturers Assn. in Washington. Contraceptive drugs and devices tend to take even longer because they are part of a risky research area that requires long-term, costly and carefully designed studies of large populations to confirm a method’s safety and effectiveness.

Less Money, Less Research

A decrease in federal funding for contraceptive research and development has also slowed progress. And some manufacturers, citing financial, political and legal challenges to their products, have cut spending as well.

That’s not to say advances aren’t being made. More contraceptives are available now than ever before, though many “new” methods are simply variations of old techniques. Meanwhile, a growing body of research about approved methods is making it easier for consumers and physicians to choose among the growing array of options. Here is a look at what’s new on the market and an update on the old standbys, along with experts’ advice about matching birth control to life style and medical history.

Oral Contraceptives: The modern-day Pill has a fraction of the hormone dose it contained when first introduced in 1960--about one-fifth the estrogen of the early Pill and 1/10th the progestin, said Rich Salem, spokesman for Ortho Pharmaceutical Corp., a Raritan, N.J., manufacturer of oral and other contraceptives.

While changes in formulation have led to the elimination or reduction of some side effects--such as facial hair and oily skin--debate about the Pill’s safety continues. After reviewing three new studies, an FDA advisory committee in January concluded that the studies did not show a “cause and effect relationship” between oral contraceptives and breast cancer. “To date,” the panel said, “it is now generally accepted that the Pill protects against endometrial and ovarian cancer and most studies have shown no overall increase in a woman’s likelihood of developing breast cancer.”

But according to the Washington-based National Women’s Health Network, studies suggest risk of breast cancer increases with more than seven years of Pill use. Along with the FDA, the network is calling for another major study of oral contraceptives and breast cancer, said Victoria Leonard, executive director.

Several studies suggest women who take the Pill are at slightly greater risk for heart disease. But a study of 120,000 women, published in the New England Journal of Medicine late last year, indicates that once Pill users discontinue use, they are at no greater risk of heart disease than other women.

The Pill’s effect on blood cholesterol is also being examined. Estrogens appear to have a beneficial effect on blood lipids, while progestins tend to have a deleterious effect, said Dr. Barry Schwarz, associate professor of obstetrics and gynecology at the University of Texas Southwestern Medical Center in Dallas.

Other research indicates that certain birth control pills reduce high-density lipoproteins, so-called “good cholesterol,” while increasing low-density “bad cholesterol.”

Though slight, such changes in blood cholesterol may be significant for certain patients but generally cause no problems, said Schwarz. Under study, too, are birth control pills designed to be “lipid-neutral.”

Oral contraceptives aren’t for everyone, including women with high blood pressure and other cardiovascular problems. Smokers should discontinue use at age 35, said Dr. Gerald Bernstein, a USC professor of obstetrics and gynecology. Nonsmokers with no other risk factors (such as obesity) are generally considered candidates until age 45, he said.

Use: 13.2 million.

Effectiveness: 97 % -99%.

Average first-year cost: $169, not including office fee.

Condoms: Two large versions and an abbreviated design have recently received marketing approval from the FDA. But the short version, called Microcondom, is sparking controversy even before it appears in drugstores.

Manufactured by SFT Laboratories in Chicago, Ill., the “partner-friendly” condom covers only the tip of the penis and is held in place by an adhesive, said Robert Greenwald, company vice president.

However, citing lack of effectiveness data, the National Women’s Health Network in December asked the FDA to rescind Microcondom’s marketing approval and last week an FDA advisory panel recommended that manufacturers of abbreviated condoms be required to prove product effectiveness. Previously, they were required only to show their products were substantially similar to those already approved.

If the recommendation to reclassify short condoms is accepted, manufacturers have 30 months to submit data on product effectiveness, an FDA spokesman said.

Two other manufacturers have developed large-size condoms, citing consumer demand and a statistic that one in four men find traditional condoms too small.

The Magnum brand, manufactured by Goleta-based Mentor Corp., is expected in drugstores soon, said spokesman Al Mannino. Wider at the tip than standard condoms, it is designed to be more comfortable, increasing compliance, he said.

Already available at drugstores and health food outlets is MAXX, “which is 25% larger than traditional condoms,” said David Mayer, president of Mayer Laboratories in Oakland.

Which types and brands are most effective in preventing the spread of AIDS and other sexually transmitted diseases is a matter of continuing debate. However, experts recommend avoiding anal intercourse, a practice deemed too risky by a U.S. Public Health Service task force last month, and eliminating the use of oil-based condom lubricants which can cause breakage.

Use: 6.9 million.

Effectiveness: 88 % -96%.

Average first-year cost: $50.

Diaphragm: First described as early as 1880, diaphragms have been a contraceptive option in the United States since the 1920s. A flexible ring covered with a dome-shaped sheet of elastic material, it is used in conjunction with spermicidal jelly.

The diaphragm itself “works by impeding sperm from getting to the cervix,” USC’s Bernstein said, while spermicidal jelly is designed to kill sperm on contact.

Critics say the diaphragm’s failure rate--estimated at 2% to 18%--makes it unreliable and that leaving the device in place six to eight hours after intercourse, as recommended, is sometimes inconvenient.

Proponents maintain it is a good alternative to hormonal contraception. “And it offers some additional protection against certain sexually transmitted diseases,” said Rich Salem of Ortho Pharmaceuticals.

Use: 1.7 million.

Effectiveness: 82 % -98%.

Average first-year cost: $129, not including office fee.

Cervical Cap: FDA-approved in 1988, this barrier contraceptive is not really new. Cruder forms were used in ancient times, historians say.

Among the advantages: It’s less fragile than a diaphragm, it can be left in place for as long as 48 hours and there is no need to reapply a spermicide with repeated episodes of intercourse, advocates say.

To be effective, the cap must be worn six to eight hours after intercourse, said Jade Singer, a physician assistant at the Westside Women’s Health Center in Santa Monica. A “big demand” followed its approval, she added, mostly from diaphragm users in their 20s and 30s. Officially called the Prentif cavity rim cervical cap, the device is manufactured by Britain’s Lamberts Inc.

“Nearly 600 different clinicians have ordered (the cap),” said Barbara Silverman, spokeswoman for Cervical Cap LTD of Los Gatos, the cap’s U.S. and Canadian distributor. Those who offer it are required to participate in a half-day training seminar provided by the 100-plus centers now studying the cap, she said.

Anatomical differences make a good fit impossible in about 30% of women, Singer said.

Use: 65,000, according to distributor estimates.

Effectiveness: 82 % -92%.

Average first-year cost: $65, not including office fee.

Spermicides: A variety of foams and gels--some packaged in applicators, some in aerosol or other forms--are available over-the-counter.

Critics cite failure rates--estimated at 21%. Proponents counter the method is accessible.

Manufacturers say they’re working to improve the efficacy of the products, reduce the number of applications needed and improve convenience. A case in point: Vaginal Contraceptive Film from Apothecus of Oyster Bay, N.Y., matchbook-size spermicide squares designed to be easily transported.

Use: 1.2 million.

Effectiveness: 79% .

Average first-year cost: $75.

IUDs: The popularity of intrauterine devices peaked in 1973. Then came reports about the Dalkon Shield--linking it with infection, sterility and spontaneous abortion--and the device fell from favor.

Three years ago, “when all major manufacturers withdrew their uninsurable products from the market, the device seemed doomed for extinction,” according to a newsletter published by the American College of Obstetricians and Gynecologists. Only the Progestasert, manufactured by Alza Corp. of Palo Alto, remained on the market. Some women traveled to Canada to obtain IUDs or sought out U.S. physicians who had stockpiled the devices.

Now, experts say, IUD use may be entering a new era--one of cautious prescription for certain women. A new version called ParaGard went on the market last year. Developed by the Population Council and GynoPharma of Somerville, N.J., the copper-containing device is designed to remain in place four years. The Progestasert, which works by releasing small amounts of a birth control hormone, lasts about a year.

Better design has reduced the likelihood of bacterial entrapment and subsequent infection, experts say. Still, physicians are prescribing IUDs with caution and ruling them out for certain women.

Best candidates: those who have had at least one child, have no history of pelvic inflammatory disease or sexually transmitted diseases and are in mutually monogamous relationships.

At least one study suggests a single dose of antibiotics before insertion may reduce risk of infection.

How the IUD works is not clearly understood. Researchers speculate it prevents fertilization and that it may also prevent implantation of the fertilized egg.

Use: 1.1 million.

Effectiveness: 97 % -99%.

Average first-year cost: $86-$140, not including office fee.

Sponges: The Today sponge, available over-the-counter since 1983, can be inserted as long as 24 hours before intercourse. But it must remain in place at least six hours after to be fully effective, said Karen Richards, spokeswoman for Whitehall Laboratories in New York, which purchased the sponge’s original manufacturer, VLI Corp. of Irvine.

The spermicide used, nonoxynol-9, is also thought to stop the spread of certain sexually transmitted diseases. But skin sensitivity to nonoxynol-9 is not uncommon, physicians say.

Shortly after its introduction, the sponge was linked with cases of toxic shock syndrome, a bacterial infection marked by high fever, vomiting, diarrhea, low blood pressure and shock. In 1984, after reviewing 12 confirmed cases believed linked to the sponge--none fatal--the FDA deemed the device a “relatively safe product.”

Like other barrier methods, the sponge requires user motivation, physicians say.

Use: 1.1 million.

Effectiveness: 72 % -86%.

Average first-year cost: $165.

Sterilization: The most popular birth control method in the United States, an estimated 13.8 million men and women rely on it, according to the Alan Guttmacher Institute, a private New York foundation studying family planning issues.

Tubal ligation, a procedure done under general or local anesthesia, involves blocking a woman’s Fallopian tubes to prevent eggs from reaching the uterus. Increasingly, the procedure is done through a laparoscope, an instrument introduced surgically into the abdomen, he added.

Males undergoing vasectomy usually require only a local anesthetic before the vas deferens or spermatic duct is obstructed, usually by tying, cauterizing and removing a segment to prevent sperm transport. Researchers are studying techniques to make the procedure simpler and more effective and to reduce recovery time.

Success rates for reversals have increased steadily over the years. “But the chance for reversal depends on how the original surgery was performed and the condition of the tubes or vas deferens,” said a spokeswoman for the Assn. for Voluntary Surgical Contraception in New York. “For some people, the chances of reversal are very small.”

“If the tubes can be reconstructed, the chance of pregnancy is about 60%,” said a spokeswoman from the Alan Guttmacher Institute. The success of vasectomy reversals varies widely, she added, ranging from 18% to 60%, as determined by pregnancy rates.

Sterilization regret may be more prevalent than previously believed. A 1988 Canadian study found that 25% of women surveyed regretted their sterilization decision, conflicting with earlier research that found less than 5% do.

But based on his own practice and anecdotal reports from colleagues in the Northeast, Dr. Alan DeCherney, a Yale professor of obstetrics and gynecology, believes the number of women who regret sterilization is declining. He attributes this partly to improved counseling prior to surgery.

Use: 5.7 million men; 8.1 million women.

Effectiveness: 99%.

Average cost: $322 to $1,335 for tubal ligation; $240-$511 for vasectomy, including fees for doctors and facilities.

Use, effectiveness and cost statistics from the Assn. for Voluntary Surgical Contraception, New York; Westside Women’s Health Center, Santa Monica; the Alan Guttmacher Institute, New York; Cervical Cap LTD, Los Gatos.

BIRTH CONTROL IN THE U.S.

Millions How Approximate Method of Users Effective Cost Sterilization 13.8 99% -------- Tubal ligation 8.1 99% $322-1,335 Vasectomy 5.7 99% $240-511 The pill 13.2 97-99% $169 Condom 6.9 88-96% $50 Diaphragm 1.7 82-98% $129 Cervical cap * 82-92% $65 Spermicide 1.2 79% $75 IUD 1.1 97-99% $86-140 Sponge 1.1 72-86% $165

Sterilization costs include physicians’ and facility fees, if any. Wide range of costs is because sterilization can be either an inpatient or outpatient procedure. Source: 1982 statistics from the Assn. for Voluntary Surgical Contraception, New York. Dollar figures are adjusted to reflect current values.

Other costs are average first-year amounts, based on 100 episodes of coitus. They do not include fees for doctor’s office visits. Sources: Alan Guttmacher Institute, New York, and Westside Women’s Health Center, Santa Monica.

*There are no available user numbers for the cervical cap because it is a new birth control method, approved by the U.S. Food and Drug Administration in May, 1988.