The Bay Area Reporter - November 2, 2000
Terry Beswick

"Anyone currently using N-9 as a microbicide to protect themselves from HIV transmission during anal intercourse should be informed of the ineffectiveness of this agent and warned of the potential risk of this practice," wrote CDC official Dr. Helene Gayle.

While cautioning that lubricated condoms and sexual lubricants that contain the spermicidal detergent known as N-9 "might not" result in a 50 percent higher rate of HIV infection - as seen in one large study of African women completed earlier this year - Gayle wrote that "the possibility of risk, with no benefit, indicates that N-9 should not be recommended as an effective means of HIV prevention."

Citing the CDC letter and a September 7 article in the Bay Area Reporter, Steven Tierney, San Francisco Department of Public Health HIV prevention director, issued a statement last month emphasizing that "nonoxynol-9 is no longer recommended as a source of protection from HIV infection."

Nevertheless, based on "the stated desires of our various clients," DPH has decided to continue to distribute condoms and lubricants containing N-9, as well as products that do not contain the caustic spermicide, Tierney said in the October 10 letter to local HIV prevention organizations.

"If given a choice, a condom lubricated with N-9 is clearly better than using no condom at all," Tierney asserted, without citing any evidence to support this claim.

"We intend to continue to monitor the research," Tierney added. "We will continue to work aggressively to publish study results that clarify the issues discussed here."

However, it is not clear what study results Tierney is referring to, as there has been no research completed on nonoxynol-9 for the prevention of HIV in anal intercourse, in any concentration. Nor is there any research ongoing or planned by DPH, CDC, or anyone else.

"It should be noted that, other than an unrelated study reporting on the effects of N-9 on the rectal tissue of rats (conducted by researcher David Phillips and reported in the B.A.R.), no studies have been conducted regarding the effects of N-9 on rectal tissues, particularly among gay men," stated Tierney.

"We did a planning meeting with community providers (23 people present), representing our partners who distribute condoms," Tierney said in an October 16 e-mail, explaining the decision to continue to distribute N-9.

"We were told that women clients particularly like and want the spermicide N-9 and wanted to have them available. Until we get more data we will continue to honor that request, as stated."

Evidently, some women use the spermicide for birth control without condoms.

At press time, DPH did not respond to repeated requests for clarification.

In the meantime, most retailers and manufacturers continue to sell products with N-9, and while the CDC had stated in August that it would be reviewing its current HIV prevention guidelines, suggesting the use of a condom with or without N-9, the agency does not expect to revise its guidelines until next spring at the earliest.

The CDC does not have the authority to remove N-9 from the market or to require manufacturers to change the labels on products containing the chemical. That authority rests with the Food and Drug Administration, which currently has no plans to do so.

"I think it's pretty clear we have to tell men who have sex with men not to use it," Dr. Lynn Paxton, a microbicides expert at the CDC, told Reuters news service on July 12. "I think they are most at risk and I know they are using it."

At least one manufacturer has voluntarily decided to remove N-9 from its product line, however, anticipating decreased market demand, and was critical of the reluctance of public health agencies to take a stronger stand against N-9.

"I think they should err on the side of safety," commented Michael Trygstad, president of Trigg Laboratories, which manufactures Wet brand lubricants. "There's never been a study of N-9 in gay men. They've decided there's not enough money in it to make it worthwhile to invest in the research."

"How much data do you need exactly?" asked Carol Queen, education director for retailer Good Vibrations, which decided to take N-9 products off its shelves several years ago due to concerns that caused irritation in too many people. "If anybody is using it alone as a preventive for HIV, they'd better be using a big percentage, and if they're using a high percentage, it's probably causing irritation, which ups the chances of HIV infection."

The San Francisco AIDS Foundation and the Stop AIDS Project have ceased distribution of condoms or lubricants containing N-9, and DPH has refused to state which organizations have requested continued access to N-9.

In the African study sponsored by UNAIDS, reported on in the September 7 issue of the B.A.R., women were given a gel containing a 3.5 percent concentration of N-9.

In the U.S., most lubricants and lubricated condoms sold over the counter contain concentrations of about 1 percent, which has not been studied, and can range as high as 4 percent. Many products do not indicate on their labels what percentage of N-9 they contain.

It is not known whether a 1 percent N-9 solution is actually too low to kill sperm or HIV - rendering it useless for the stated purpose - or whether it is even a sufficient dose to cause perforations in the vaginal or rectal walls, as seen in animal and human studies.

It is also impossible to say whether gay and bisexual men in San Francisco and elsewhere have been infected with HIV as a result of their use of N-9 - ironically, under the mistaken assumption that the spermicide will help protect them from HIV.

"Probably, there are still some AIDS organizations out there promoting N-9 as safe and effective," said Trygstad.

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