Business Wire - September 26, 2002

N-9 is the active ingredient in all over-the-counter contraceptive products and is added in smaller amounts to some sexual lubricants and to the outer surface of some condoms.

"We are concerned that many people mistakenly believe that N-9 provides extra protection against HIV and STDs when studies show that N-9 increases risk of infection when it is used rectally," said Lori Heise, Director of the Global Campaign for Microbicides, the group spearheading the "Call to Discontinue N-9 for Rectal Use." The Call can be found at www.global-campaign.org.

Forty-two percent of all condoms sold commercially in the U.S. are lubricated with N-9. In a recent survey, 41% of gay men actively sought out lubricants containing N-9. Organizers of the Call emphasize that removing N-9 from condoms and lubricants would benefit women as well as gay men. Studies from the U.S. indicate that between 6% and 13% of women engaged in anal sex within the last year.

"Recent research has shown that even small amounts of N-9 can cause sloughing of the cell lining of the rectum, potentially increasing one's risk of contracting HIV," said Dr. Kenneth Mayer, Professor of Medicine at Brown University and Board member of the American Foundation for AIDS Research (amfAR). Both the World Health Organization and the U.S. Centers for Disease Control and Prevention have recently cautioned against rectal use of N-9 and issued guidance clarifying that N-9 does not prevent HIV or STD transmission.

Signers of the Call include amfAR, Planned Parenthood, Gay and Lesbian Medical Association, National Women's Health Network, and the Association of Reproductive Health Professionals.

Heise noted that there is still serious confusion about N-9 among health care providers, AIDS educators, and consumers. Early research suggested that N-9 might offer some protection against HIV, but this research has since been proven wrong.

"The belief that N-9 helps prevent HIV is deeply entrenched and 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," said Heise.

Organizers of the Call began approaching condom and lubricant manufacturers in June, requesting that they voluntarily remove N-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 yesterday's Wall Street Journal, a number of manufacturers, including Mayer Laboratories-distributor of Aqua Lube and Kimono condoms-and Planned Parenthood Federation of America, which distributes its own Planned Parenthood brand of condoms, have agreed to voluntarily remove products containing N-9. Heise said "They stand as leaders in corporate responsibility by taking the high road and agreeing to put public health above profits."

Others, especially the top three condom manufacturers-Ansell Ltd., maker of Lifestyles condoms; Church & Dwight Company, maker of Trojan; and SSL International PLC, the parent company of Durex-have resisted, arguing that N-9 lubrication on condoms provides women with back-up protection against pregnancy in case of condom failure.

The companies, however, have no data to substantiate that claim. The WHO consensus report, concludes, "There is no evidence that N-9-lubricated condoms provide any additional protection against pregnancy or STDs compared with condoms lubricated with other products. Since adverse effects due to the addition of N-9 to condoms cannot be excluded, such condoms should no longer be promoted."

In addition to asking manufacturers to act responsibly, the Call encourages retailers to voluntarily remove lubricants and condoms containing N-9 from their shelves and demands accelerated research into microbicides-products that could be used vaginally and rectally to help prevent HIV.

CONTACT: Global Campaign for Microbicides Lori Heise, 202/454-5028 Cell: 301/580-5344 lheise@path-dc.org www.global-campaign.org

SOURCE: American Foundation for AIDS Research

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