Wall Street Journal - September 25, 2002
Rachel Zimmerman Staff Reporter of The Wall Street Journal

Drug giant Johnson & Johnson is among the producers halting manufacturing of N-9-enhanced lubricants and condoms, which are still widely used despite the new data detailing potential health risks, particularly involving anal sex.

But some leading makers aren't eliminating their spermicide-treated condoms, products that account for about 40% of the $295 million U.S condom market. Experts say N-9 is the only kind of spermicide used in condoms and lubricants domestically, and accounts for a significant share of the world-wide condom market, which is about $4 billion. Use of N-9 condoms and lubricants has been widespread among gay men, largely because of a belief that they offer some protection from HIV and other sexually transmitted diseases.

Scientists, public-health advocates, gay-rights groups and some women's organizations are planning a public-awareness campaign next month to attack N-9. "In the interest of public health, the safest thing to do is eliminate N-9 condoms and lubricants from the market," says campaign organizer Lori Heise of the Program for Appropriate Technology in Health, or Path, a Seattle-based nonprofit that works on women's health and AIDS prevention in developing countries.

N-9, originally developed as a detergent, has been used for nearly 50 years as a vaginal cream that rapidly kills sperm cells. Cautions on N-9 have been trickling out for at least two years. But this summer, the World Health Organization and the U.S. Centers for Disease Control and Prevention reinforced concern by issuing warnings that the additive has been found to be ineffective in stopping the AIDS virus and other diseases contracted sexually.

The groups involved in the coming publicity campaign intend to recommend that N-9 not be used during anal intercourse, by prostitutes, by anyone engaged in multiple acts of intercourse in one day, or to prevent sexually transmitted diseases. N-9 is also present in many spermicides used with diaphragms and cervical caps, but the groups believe they can be used safely by women not at risk for HIV.

Researchers say that N-9, working like a strong soap, can break up or irritate the cell lining, or epithelium, of the rectum and the vagina -- the first line of defense against HIV and other diseases. Such irritation can make it easier for a virus or other infective organism to invade. The danger in anal sex is especially significant because the rectum has only a single-cell wall; the vagina has a wall that is about 40 cells thick.

When it comes to condoms, many of which are treated with N-9 inside and out, there is more HIV risk if the condom slips, breaks or is misused. But there is also possible danger of N-9 breakdown of the anal or vaginal epithelium whether the condom breaks or not. Unprotected sex within a few hours of the damage could lead to infection.

A study to be published in the Lancet medical journal this week details findings first reported on a preliminary basis at an AIDS conference in South Africa in 2000. The study -- a randomized, controlled clinical trial sponsored by UNAIDS, the United Nations agency dealing with the AIDS crisis -- involved 991 prostitutes in Thailand, South Africa and the Ivory Coast who had an average of 3.6 sex partners a day. The study found that the women who used an N-9 spermicide had more genital lesions and higher rates of HIV than other women using a placebo.

More recently, David Phillips, a senior scientist with the Population Council in New York, found in a small study that even low doses of N-9 caused heavy sloughing, or peeling, of the rectal epithelium. Mr. Phillips conducted his study in 2001 by inserting KY Plus, a Johnson & Johnson lubricant containing N-9, rectally in men and women. After 15 minutes of exposure, he found significant sloughing of the epithelium. The epithelium regenerated within eight to 10 hours. "N-9 breaks membranes. That's why it cleans clothes, that's how it damages cells," says Mr. Phillips. "It allows the virus to penetrate faster and to get to the main target cells below it."

Marc Monseau, a spokesman for Johnson & Johnson, says the company ceased production of its KY Plus lubricant in July because sales of the product were declining. However, he says, the company's decision to phase out its N-9-treated condoms, early next year, "followed an evaluation of the recent recommendations" from the WHO and others. The condoms are manufactured in Brazil for sale in that country and Colombia.

Others who are stopping sales of N-9 products include Planned Parenthood, the nonprofit group that distributes condoms at its clinics, and Mayer Laboratories Inc., which says it is the fourth largest condom maker in the U.S.

A spokesman for the Advanced Medical Technology Association, which represents medical-device makers, says that the top three condom makers have no plans to pull their products from the market. One of these is Armkel LLC, a joint venture between Church & Dwight Co. and Kelso & Co., which makes Trojan condoms, the No. 1 selling U.S. brand. Richard Kline, Armkel vice president of marketing, says the company is working with the Food and Drug Administration to improve labeling, but he says that the N-9 condom is still an important product for women as a backup contraceptive.

According to a person familiar with the talks, the new label will likely say something like: "for vaginal use only."

Mr. Mayer says that when he launched his condom business in 1987, there was pressure from public health officials and the gay community to produce condoms with N-9. At that time, researchers believed that spermicides might be effective in preventing HIV and other infections. Detergents inactivate viruses and kill bacteria, the thinking went, so maybe N-9 would inactivate HIV. Subsequent studies appear to have disproved that theory.

Write to Rachel Zimmerman at rachel.zimmerman@wsj.com
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