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For Women: Safer Sex

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TIMES HEALTH WRITER

With cases of AIDS soaring among women, health experts are taking a hard look at an old question. When a woman’s partner won’t wear a condom, is there another way for a woman to protect herself from HIV and other sexually transmitted diseases?

Researchers at dozens of U.S. organizations are working on a safe-sex solution for women, focusing on a promising group of chemicals called microbicides. The effort is being given high priority by women’s health advocates, AIDS researchers and public-health officials as experts acknowledge that education programs don’t hit home with everyone.

“Our prevention program message has been condoms, monogamy or abstinence,” says Anna Forbes, U.S. field organizer for the Alliance for Microbicide Development, a consortium of international health experts. “But for some people, that just doesn’t work. Not all women can insist on condom use.”

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While “microbicide” may sound like something sprayed on crops or kitchen counter tops, it is a catchall term for substances that could be used topically by women to kill a variety of viruses and bacteria. A woman would apply the substance, in the form of a gel or foam, to her vagina before sex.

In developing microbicides, researchers are building on their knowledge of spermicides--the foams, jellies and creams that are usually used with condoms for birth control. These easy-to-use sperm-killing chemicals do not harm vaginal tissues.

“We’re looking for something that instead of killing sperm, kills or immobilizes HIV” as well as bacteria and viruses, says Forbes. Sexually transmitted bacterial infections include gonorrhea; viral STDs include herpes and hepatitis B.

Microbicides aren’t likely to be available on pharmacy shelves any time soon. Reproductive health experts estimate that the products could become available within five years, provided that there is adequate research spending.

While most of the research focuses on preventing various STDs, the increased incidence of HIV infection in women has catalyzed the field, Forbes says. “We’re seeing the worldwide rates of HIV infection among women going through the roof,” she says. “Women are now becoming infected faster than men.” In sub-Saharan Africa, more women than men are now infected with HIV, according to the World Health Organization.

In the United States, HIV infection among women is also rising quickly. This year, women will make up 30% of all new infections, according to the Centers for Disease Control and Prevention. About three in four new infections among U.S. women come from heterosexual sex.

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Women are also the fastest-growing group of people with full-blown AIDS. AIDS in women increased from 7% of newly diagnosed cases in 1985 to about 24% in 1998.

Research on microbicides has also gained momentum as scientists have recognized that it may take longer than originally thought to develop an effective and safe AIDS vaccine. “It’s going to be substantially easier to develop a microbicide than an HIV vaccine, although we need both,” says Forbes.

While STDs generally are not life-threatening, they take a huge toll on Americans, experts say. About 15 million new STD cases occur each year, according to the Alan Guttmacher Institute, a reproductive health group in New York City.

Women tend to suffer disproportionately from the effects of STDs because the lack of symptoms in women (as compared to men) can lead to lingering infections. The human papilloma virus, for example, can cause cervical cancer; other STDs can lead to pelvic inflammatory disease and infertility.

“HIV is not a prime concern of most American women. But we have an epidemic of STDs here that women are worried about,” says Anne-Marie Corner, president of Biosyn, a Philadelphia company that is developing a microbicide called Savvy.

In a survey conducted in 1999 by the Alan Guttmacher Institute of women ages 18 to 44, 40% said they would be interested in an alternative method of STD protection that would give the woman control over usage.

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The most popular forms of birth control are the pill and sterilization, but neither prevents STDs. When used correctly, condoms can stop transmission of many STDs--although they do not always protect against herpes and human papilloma virus. But many Americans are ambivalent about condom use.

A 1998 survey by the Kaiser Family Foundation found that only about half of adults had talked to sexual partners about their history of STDs. Only 34% of women and 28% of men who had STDs said they informed their most recent or current sexual partner of their condition prior to having sex.

“It is a problem for women everywhere, at different points in their lives and in different relationships,” said Polly Harrison, a reproductive health expert who founded the Alliance for Microbicide Development in 1998. “We also know there is attrition in condom use, and we know use is imperfect.”

More than 60 potential microbicides are already in various stages of research and development, with a few entering large clinical trials, says Forbes. In April, a government conference on the topic in Washington, D.C., drew 6,000 people--three times the expected number of participants. Moreover, a recent report on HIV prevention by the Institute of Medicine, a prestigious advisory panel that makes recommendations to the federal government, strongly endorsed microbicide research.

The microbicide effort has also drawn support from actress Jane Fonda and Microsoft’s Bill Gates and his wife, Melissa, who donated $25 million to the research effort.

But research spending on microbicides--estimated at $35 million a year in total--is still a pittance, experts say. Experts say it will take $100 million over five years to move even one product from the laboratory to market.

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Though many small biotech companies, including several in Southern California, are working on various agents, major pharmaceutical companies have been reluctant to join the research effort.

“Clinical trials are very expensive to run, and big pharmaceutical companies are concerned about profitability,” says Forbes. “A product that costs pennies per use is not going to generate a lot of money.”

The federal government is currently spending $25 million to assist small organizations doing microbicide research, but that represents only 1% of the government’s AIDS research budget. Rep. Connie Morella (R-Md.) has introduced legislation to increase federal funding to $100 million by 2003.

The challenges of developing a microbicide were evident earlier this year when a study of the spermicide nonoxynol-9--which kills HIV in a test tube--found that it failed to protect female prostitutes in Africa against the virus. Scientists hope to study whether nonoxynol-9 would prevent HIV in people who have sex a few times a week. In August, the U.S. government issued a warning to health professionals to stop recommending nonoxynol-9 for HIV prevention.

While the jury is still out on nonoxynol-9, health experts say that microbicide products now in development are more technically sophisticated.

“People used to think we should take old chemicals that we knew would kill sperm--like nonoxynol-9,” says Biosyn’s Corner. “Now we are seeing really novel molecules. . . . We are also increasing our understanding of how HIV is transmitted intra-vaginally.”

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As researchers try to develop an effective and safe microbicide, they have several features in mind: The product should be easy to use, comfortable, inexpensive and sold over the counter. Various companies are exploring the use of foams, gels, suppositories, sponges, vaginal rings and vaginal film.

Many U.S. companies are working on products to protect against both pregnancy and STDs; others are developing substances that target only STDS. Such products would allow women to become pregnant, a feature that may be more popular among women in developing nations. Still, other research efforts are focusing on microbicides that would prevent transmission of infection among gay men.

(BEGIN TEXT OF INFOBOX / INFOGRAPHIC)

The STD Problem

About 15 million new cases of sexually transmitted diseases are disgnosed each year in the United States.

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STD New Cases Chlamydia 3 million Gonorrhea 650,000 Hepatitis B 77,000 Herpes 1 million HIV 20,000 Human Papilloma Virus 5.5 million Syphilis 70,000 Trichomoniasis 5 million

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United States, 1996 Source: U.S. Centers for Disease Control and Prevention (BEGIN TEXT OF INFOBOX / INFOGRAPHIC)

Women and Aids

Women represented about 24% of newly diagnosed AIDS cases in 1998--the fastest growth of any U.S. group.

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