amfAR, The Foundation for AIDS Research

amfAR Joins Call for Removal of N-9 from Condoms and Lubricants

On September 26, 2002, amfAR joined a broad-based coalition of over 85 leading scientists and health groups in calling on manufacturers of condoms and lubricants to voluntarily remove nonoxynol-9 (N-9) from their products.

Nonoxonyl-9 is the active ingredient in most over-the-counter spermicidal products available in the United States and has been widely available as a contraceptive since the 1950s. It is also added in smaller amounts to some sexual lubricants and to the outer surface of many condoms. Approximately 42 percent of condoms sold commercially in the U.S. use nonoxynol-9.

Lori Heise, director of the Global Campaign for Microbicides, the group spearheading the "Call to Discontinue N-9 for Rectal Use," explains the problem: "We are concerned that many people mistakenly believe that N-9 provides extra protection against HIV and other STDs when in fact studies show that N-9 increases risk of infection when it is used rectally."

N-9-containing condoms and lubricants became even more popular in the mid-1980s when early research suggested that it might offer some protection against HIV and other STDs. But recent evidence shows that not only is N-9 ineffective against bacterial STDs such as gonorrhea and chlamydia, but that it could also increase susceptibility to HIV.

In fact, even low doses of N-9 have been shown to cause shedding of the cells lining the rectum, potentially

 

[N-9] can damage the cells lining the rectum ... providing a portal of entry for HIV and other sexually transmissible agents. [It] should not be used as a microbicide or lubricant during anal intercourse. U.S. Centers for Disease Control and Prevention 

increasing the risk of contracting or transmitting HIV. In response to this data, both the U.S. Centers for Disease Control and Prevention and the World Health Organization (WHO) have recently cautioned against rectal use of nonoxynol-9 and issued guidelines clarifying that N-9 does not prevent transmission of HIV or other STDs. (Nonoxynol-9 also has so-called “detergent” effects when used vaginally, but the damage caused to vaginal tissue is much less than that caused to the lining of the rectum.)

Call to Discontinue N-9 for Rectal Use 

Despite clearcut evidence that nonoxynol-9 can increase the risk of infection with HIV and other sexually transmitted diseases, there is still confusion about N-9 among health care providers, AIDS educators, and consumers. As Ms. Heise explains, “[It] would take years and a massive public education campaign to set the record straight. The most prudent thing to do is to eliminate the risk by removing N-9 from lubricants and condoms now.”

Organizers of the “Call to Discontinue N-9 for Rectal Use” have been approaching condom and lubricant manufacturers since June 2002, requesting that they voluntarily remove nonoxynol-9 from their products. All manufacturers that add N-9 to their lubricants and condoms also sell versions of their products without N-9.

As reported in the Wall Street Journal on September 25, 2002, several condom and spermicide manufacturers, including Mayer Laboratories, have said that they will soon halt production of products containing N-9. (Trimensa subsequently agreed to stop making products that contain N-9). But the three largest condom manufacturers have no plans to pull products containing N-9 off the market. The companies who are resisting the “Call to Discontinue N-9 for Rectal Use” are Ansell Ltd., maker of Lifestyles condoms; Church & Dwight Company, maker of Trojan; and SSL International PLC, the parent company of Durex.

 

There is no evidence that N-9-lubricated condoms provide any additional protection against pregnancy or STDs compared with condoms lubricated with other products. —World Health Organization 

These firms are claiming that N-9 lubrication on condoms provides women with back-up protection against pregnancy in case of condom failure. But as the World Health Organization concluded in its report on N-9, “There is no evidence that N-9-lubricated condoms provide any additional protection against pregnancy or STDs compared with condoms lubricated with other products.”

Public Health Implications 

Studies show that most men who have sex with men (MSM) use lubricants, or "lubes," during anal intercourse. One study found that than three-fouths of gay men use lubricants at least 80 percent of the time. Of these, 41 percent actively sought out products containing N-9.

Anal intercourse has traditionally been viewed as the domain of men who have sex with men; however, studies indicate that anywhere from 6 to 13 percent of heterosexual women in the U.S. engaged in receptive anal sex in the last year. One federally funded study found that 32 percent of female participants at high risk of contracting HIV reported having had anal sex in the past six months.

Among the organizations joining amfAR in support of the “Call to Discontinue N-9 for Rectal Use” are AIDS Action, the Alan Guttmacher Institute, the Association of Reproductive Health Professionals, Gay Men’s Health Crisis, National Women’s Health Network, Planned Parenthood, and the San Francisco AIDS Foundation.

In addition to asking manufacturers to act responsibly, organizers are encouraging retailers to voluntarily remove condoms and lubricants containing N-9 from their shelves and demanding accelerated research into microbicides—products that could be used vaginally or rectally to help prevent HIV transmission.