Government looks at spermicides’ effectiveness

GAITHERSBURG, Md. (AP) — The government is casting doubt on how well decades-old contraceptive foams and gels actually prevent pregnancy. But its scientific advisers said Wednesday the spermicides do appear to reduce women’s risk of catching the common sexual diseases of gonorrhea and chlamydia.
The advisers to the Food and Drug Administration said Wednesday that the spermicides appear to prevent some venereal diseases despite growing concern that women who use them might actually increase their risk of catching the AIDS virus.
“Is a balance between a decrease in gonorrhea and chlamydia offset by an increased risk” of the AIDS virus? That was a question posed Wednesday by Dr. Penelope Hitchcock of the National Institutes of Health. “We don’t have the answers,” she added.
On the contraceptive issue, the FDA’s Dr. Lisa Rarick said: “It’s scary to think there are products out there with failures in the 40 to 50 percent range. Women should know how well these products work.”
The FDA opened a three-day meeting Wednesday to hash out these issues with outside scientists.
Spermicides hit the market in 1950, before federal law required new drugs to prove how effective they were. Now, almost five decades later, manufacturers are furious about an FDA plan to make them prove their products’ effectiveness at preventing pregnancy through expensive clinical trials.
Some women already have begun using spermicides for disease protection when a partner won’t use a condom. And researchers are now trying to see if and just how the foams and gels actually prevent or combat disease.
Nonoxynol-9, the chief spermicide ingredient, appears to kill sexually transmitted bacteria that cause gonorrhea and chlamydia. A study of 818 women who attended disease clinics in Birmingham, Ala., in the 1980s found those who used spermicides lowered their risk of catching those two diseases by 21 percent to 25 percent.
“The evidence for N-9 is compelling,” said Dr. David Upmalis of Advanced Care Products, a Johnson & Johnson subsidiary that is the largest spermicide maker. “We need to let women know.”
The FDA advisers, on an 18-1 vote, said Nonoxynol does appear effective against gonorrhea and chlamydia. But, citing theories that couples would be less likely to use condoms — the gold standard for disease protection — they were much more divided on whether to actually recommend them as a safeguard against disease.
The committee emphasized that the spermicides must be labeled to clearly tell women that condoms remain the best preventative to sexually transmitted diseases, and that protection against gonorrhea and chlamydia does not equal protection against HIV.
The advisers postponed until Thursday discussion of whether the same women who seek protection against gonorrhea and chlamydia with spermicides might actually be increasing their risk of getting HIV, the AIDS virus.
Nonoxynol kills the AIDS virus in test tubes. But other studies show nonoxynol also irritates the vagina, raising the fear that it could let the HIV virus more easily infect women.
Some studies are under way in Africa and Thailand, where enough women catch HIV every year for researchers to see if the spermicides have an effect. If so, the question becomes whether the FDA will accept that foreign data as sufficient to prove Americans, too, could benefit.
Meanwhile, spermicide manufacturers are afraid that a pending FDA plan to make them prove spermicides’ contraceptive effectiveness could stymie that research. The expensive clinical trials might lead some companies to simply stop selling spermicides in the United States, they say.
The FDA will ask the advisory panel on Friday to settle whether it is asking too much of spermicide makers to demand that evidence.
Surveys suggest the chance of getting pregnant while using spermicides is 21 percent, far higher than with other contraceptives. But spermicides come as gels, foams, creams, suppositories and even a vaginal film — and the FDA suspects some are significantly better than their competitors but cannot provide any data to women trying to make the choice.
Chlamydia strikes 4 million Americans a year, and gonorrhea 800,000. If untreated, the diseases can lead to infertility and raise the risk of HIV infection.