misc.health.aids
threadDate: 2000-10-02 06:50:08 PST
The Bay Area Reporter can be contacted at:
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N-9 can cause HIV infection

by Terry Beswick

For years, men and women have been using sexual lubricants and pre-lubed condoms containing a spermicidal detergent called nonoxynol-9 (N-9) believing that they are protecting themselves from HIV and other sexually transmitted diseases.

Now, it appears that they have been wrong. Dead wrong.

And thus far, no public or private agency in San Francisco has taken steps to warn them about it, though one lube manufacturer has recently taken the substance out of their product.

"N-9 has now been proven ineffective against HIV transmission, [and] the possibility of risk, with no benefit, indicates that N-9 should not be recommended as an effective means of HIV prevention," read a "Dear Colleague" letter dated August 4 from Dr. Helene Gayle, director of the National Center for HIV, STD, and TB Prevention of the Centers for Disease Control and Prevention.

N-9, a spermicide approved by the Food and Drug Administration for use as a contraceptive, is widely added to many sexual lubricants and condoms. Although it was previously believed that the chemical could reduce the risk of HIV infection, the additive could actually be leaving consumers more vulnerable to infection by creating perforations in the vaginal or rectal walls.

"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," said Gayle.

Gayle's letter was prompted by a study of over 1,000 African female sex workers, in which half of the women were given a gel laced with N-9, and the other half were given a placebo gel that appeared to be identical, but contained no N-9. Both groups of women in the study, sponsored by the Joint United Nations Programme on AIDS, were reportedly encouraged to use condoms, though many relied on the gel.

The women using the N-9 gel were about 50 percent more likely to be infected than those using the placebo.

"Further, the more frequently women used only N-9 gel (without a condom) to protect themselves, the higher their risk of becoming infected," Gayle reported. "Simply stated, N-9 did not protect against HIV infection and may have caused more transmission. Women who used N-9 also had more vaginal lesions, which might have facilitated HIV transmission."

Because the FDA never approved use of N-9 as a microbicide to protect against HIV infection, lubricant manufacturers do not claim that it helps prevent infection on their product labels. Also for this reason, FDA is not likely to issue a recall of products containing N-9, and has not issued a warning to anyone using it in anal intercourse.

The CDC plans to review its current prevention guidelines, which recommend use of a condom "with or without a spermicide," over the next few months.

Wet dumps N-9

Virtually all water-based lubricants are available with or without N-9, and as a result of the CDC letter, at least one manufacturer has decided to eliminate N-9 altogether.

"We've voluntarily taken it out of our products, based on the letter from the CDC," Michael Trygstad, CEO and founder of Trigg Inc., told the Bay Area Reporter. Trygstad's company manufactures the Wet line of sexual lubricants, with substantial marketing programs targeting the gay community. "I felt the responsibility to take it out."

Very little research has been done looking at the utility of microbicides in anal sex in people, and Gayle's letter did not mention gay men specifically. But because the lining of the vagina is capable of sustaining much more "wear and tear" than the lining of the rectum, in lieu of waiting years for the research to be even funded, the risk of using N-9 extends to anyone who practices anal sex.

The UNAIDS study used about three-and-a-half times the concentration of N-9 as had been used in Wet Original, which contained a 1 percent solution. Robin Ogilvie, CEO of Trimensa, which manufactures Foreplay lubricants, said that he will not be removing N-9 from his products which contain a lesser concentration, about a tenth of 1 percent. Saying that there are "an equal number of positives as negatives about the product," Ogilvie nevertheless acknowledged that his company had reduced the concentration of N-9 in Foreplay from 1 percent to .1 percent about 18 months ago when a study involving cats showed that the higher concentration caused significant irritation to the rectal tissue. The lower concentration was not studied.

Other studies have shown that N-9 can be dangerous to both mice and men, leaving them vulnerable to infection. The B.A.R. reported on March 23 on a study from Dr. David Phillips, a senior scientist with the Population Council, in which mice were easily and quickly killed by a herpes virus when their rectums were previously treated with an N-9 solution. Looking at a biopsy of the rectal tissue under a microscope, Phillips found "places where there was no epithelium at all, just connective tissue. The N-9 had stripped the epithelial cells off of these animals."

Phillips then looked at the chemical's effects on the rectal tissue of four human volunteers, comparing over the counter lubricants containing 1 percent or 2 percent N-9. The results were "striking," Phillips said with "sheets of epithelial cells, hundreds of them, in each one of the samples."

Despite this accumulating evidence, the San Francisco Department of Public Health has no plans to issue an alert about N-9, and while area prevention organizations do not recommend use of N-9 as a means to prevent HIV infection, they also do not recommend that people do not use products that contain the chemical.

Oddly, many prevention organizations and public health workers acknowledge that it has been known for some time that N-9 causes an allergic reaction among some men, and irritation in others. Some organizations give condoms laced with N-9 only on request.

Bryan Burns, the new director of prevention services at the San Francisco AIDS Foundation, said, "We've heard of studies over the years to suggest that N-9 might be an irritant. N-9 does irritate the vaginal lining and we can assume through extension that it will irritate the rectal lining."

Pressed as to whether SFAF will change its policy and discourage use of N-9, he replied, "Perhaps. My perspective is to make sure this information gets into the hands of gay men, and let them make informed decisions about their sexual practices."

"The evidence that we have now is that there's more danger than benefit," commented Martin Delaney, founding director of Project Inform, a national HIV treatment education and advocacy group. While noting that "in fact, it takes a lot of effort to infect people," Delaney said that current research suggests that N-9 can add to the danger of HIV transmission, and called for the FDA "to issue a warning letter on it right now."

The FDA press office did not return a call for comment by press time. "The responsible thing to do is to make sure the consumer is aware as possible," said Jeff Phillips, CEO of SafeSense.com, an online retailer of condoms and lubricants. Although N-9 is by far the most common spermicide added to lubricants carried on his Web site, or on competitor Web sites like Condomania.com, Phillips noted that SafeSense.com also has a new water-based lubricant gel called "DeLube," containing a microbicide called "benzalkonium chloride."

Steven Tierney, director of HIV prevention for DPH, said that his staff will be meeting this Friday, September 8 to discuss the implications of the research that has been done on N-9.

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