VIRUSMYTH HOMEPAGE

NONOXYNOL-9: BETTER SAFE THAN SORRY?

By Bohdan Zachary

Out Magazine Feb./March 1994

A dispute over the regulation of lubricants reveals a potential hazard for AIDS. Bohdan Zachary squeezes out the truth.

During the past two years a little-publicized health battle has been waged out of the glare of the media. It concerns nonoxynol-9, a disinfectant found in everything from baby wipes to laundry detergent, as well as in sexual products such as contraceptive foams and gels, condoms, and lubricants. Invented as a contraceptive, nonoxynol-9 was found to help prevent sexually transmitted diseases (STDs) such as chlamydia, gonorrhea, and herpes by killing sperm and cells in the vaginal tract. It also kills the human immuno-deficiency virus in the test tube, according to laboratory tests of commercial sexual products. As little as 0.05 percent of nonoxynol-9 in a solution stops HIV from reproducing, while a 1 to 5 percent concentration may kill cells harboring dormant HIV.

Almost overnight nonoxynol-9 be came a household word, synonymous with safer sex. By adding nonoxynol-9 to their products, cosmetics and pharmaceutical manufacturers boosted their already multibillion-dollar sales. It was not unlike the 1980s boon to skin-care products that contained collagen, another advertising gold mine.

In the video commercial that helped turn Wet Personal Lubricant into the best-selling lubricant in the world, porn star Rex Chandler touches his nipple. "Touch me there." He pours Wet over his erect penis. Another camera angle. "Tighter," he says, "longer-hotter-feel it." The camera closes in on his contorted face as he climaxes. The screen credits end with the words: "Wet, with nonoxynol-9, aloe vera, and vitamin E."

Unknown to most consumers, however, is nonoxynol-9's reported toxicity, a downside that since 1990 has caused several national and international organizations like the U.S. Centers for Disease Control and the World Health Organization to quietly reconsider promoting its use. WHO officials had gotten wind of an increasing number of complaints by women using spermicides and contraceptive sponges with nonoxynol-9 who experienced vaginal and cervical ulcers, burning sensations, and recurring yeast infections. Many were Nairobi, Kenya, prostitutes whose sexual experiences were dismissed by some critics as unrepresentative of the average woman.

Their complaints also contradicted an initial 1980 Food and Drug Administration study that had deemed nonoxynol-9 "safe and effective . . . as a vaginal contraceptive" on the basis of one animal study of vaginal use and "lack of reports of significant adverse effect in humans [emphasis added]." But the FDA study did not base its conclusions on normal daily use of spermicides in women, nor did it address nonoxynol-9's effectiveness against STDs and HIV.

In 1991 a very different picture was painted by Dr. Kristina Bird, information officer at the London-based National HIV Information Service. In a review of nonoxynol-9 for the journal AIDS, Bird agreed that studies proved its efficacy against HIV and STDs in the test tube, but she also found: "The wider literature on these products reveals frequent minor reference to local toxicity, with rates of reported genital irritation ranging from 'minimal' to more than 10 percent." She cautioned, "The protective effects of nonoxynol-9 have not been established in vivo [in the body] for any of the viral STDs."

More important, Bird posed the frightening question that gave pause to international health officials: "Does the ability of nonoxynol-9 to inactivate lymphocytes in the test tube suggest that it may increase the body's vulnerability to infection in vivo?" That is, will nonoxynol-9 increase your risk for HIV instead of protecting you?

AIDS advocates shared a similar concern, worrying that consumers -- gay men in particular -- were relying on nonoxynol-9 to protect them and forgetting the main ingredient in safer sex: condoms. "We get lots and lots of calls from kids, young kids, wondering if they could get by with just using lubricants instead of condoms," says Michael James Gong, a former hot-line volunteer at the San Francisco Emergency AIDS Fund. "That's like putting a loaded gun to your head." Backing Gong's view are recent reports in the gay and mainstream media suggesting that an increasing number of gay men have abandoned safer-sex practices, and 'hence condoms. Meanwhile, sales of dildos and lubricants with nonoxynol-9 to lesbians have steadily increased.

Alarmed AIDS activists lobbed Bird's provocative question to the FDA, only to see it fall into an abyss of regulatory red tape, where it remains today. Government officials, it seems, can't agree about how to classify different products containing the disinfectant. Contraceptive foams and gels are classified as over-the-counter drugs by the FDA, while condoms are considered medical devices -- both classes of products used internally and therefore subject to stringent quality control. Manufacturers must list the exact percentage of nonoxynol-9 and other ingredients; the minimum concentration for contraceptives is 3 percent, but some spermicides go as high as 15 percent.

Lubricants were initially developed for external use, on the skin, particularly during sexual intercourse. As long as manufacturers make no explicit claims for disease prevention or contraception, the FDA labels lubricants as cosmetics, defined by the Federal Food, Drug, and Cosmetic Act as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions." Most lubricant makers do not list the percent age of their ingredients because of that gray area in FDA guidelines, which do not recognize that the lubricant is typically an adjunct to a medical device -- a condom. Many AIDS advocates feel that lubricants in themselves fail the cosmetics definition since they cause vaginal irritation and yeast infections.

"The situation with lubricants and nonoxynol-9 isn't all that different from what happened when the FDA did nothing about the complaints it received from women about silicon-gel breast implants," states Brenda Lein of the AIDS information group Project Inform. "It's business as usual." Lein is technically right: Breast implants, though placed (like lubricants) inside the body, are intended for cosmetic purposes not viewed as medically necessary, even for women who have lost breasts to cancer. But as with the debate over breast implants the real issue underlying lubricant regulation is not consumer safety but profit.

While the distinction between cosmetics and drugs may appear minor on paper, it represents millions to manufacturers. Getting FDA drug approval is a lengthy, money-consuming process, and many products fail the test. Not so for a cosmetic. Lubricant manufacturers, under fire from AIDS activists over nonoxynol-9, correctly argued that under FDA guidelines they are not required to list the ingredient percentages. (The FDA could use such labeling to reclassify the products as over-the-counter drugs, subject to stricter controls.) Consumers must rely on the manufacturers' claims of quality control.

Despite the growing controversy, the FDA has done little to clear up the inconsistencies in its policy over nonoxynol-9 and has directed concerned consumers to independent state agencies. Since most lubricant manufacturers are located in California, Bird's question was directed to Allen Davidson, director of the Food and Drug Branch of California Health Services. Not surprisingly his agency balked at testing lubricants with nonoxynol-9 to determine safety in terms of increased exposure to HIV. "Given our limited resources, we have to deal with those things that we consider real health hazards," contends Davidson, while admitting that "nonoxynol-9 has not been shown through well-controlled scientific studies to prevent STDs; AIDS, and/or HIV."

Davidson's response frustrates some lubricant manufacturers who worry about harming consumers and the possibility of future lawsuits if such studies are done to show nonoxynol-9 is dangerous -- even at 1 percent.

"They [regulators] don't want to categorize lubricants because they don't know where it should fall," complains Robin Ogilvie, president of Trimensa Corporation, maker of the lubricants ForPlay and PrePair. "The FDA is not creative, just very administrative."

Red tape aside, others have suggested another reason for the FDA stalemate. One agency official who requested anonymity says frankly, "Since lubricants are associated with anal intercourse, they sit very, very low on the totem pole of priorities at the FDA."

Perhaps ironically, the gay media was the first to alert the general public to the debate over nonoxynol-9, following the recall of Wet lubricant batches by its manufacturer, Dynamic Concepts, in February I992. In a letter to Wet retailers and distributors, company president Michael Trygstad informed them that "due to problems with our former manufacturer, Topco Sales," certain shipments failed to meet "our high standards for providing quality products." He urged them to return "watery" or "discolored" samples. Trygstad says that he also issued a similar letter to inform consumers but that the gay press ignored it.

While regulatory health agencies ducked the issue, three independent parties -- gay sexologist Dr. Clark Taylor, Condom Sense (a trade magazine), and the late Dr. Larry Waites (my partner and then columnist for The Advocate) -- commissioned independent laboratory tests of Wet Personal Lubricant samples, using FDA standards. All the conclusions were the same: Prior to batch No. 1170, which was issued March 9, 1993, Wet contained less than the recommended 1 percent concentration of nonoxynol-9. When Waites published his lab's results in an Advocate article, Wet's Trygstad protested and a fax war broke out between the two. The debate spread to other lubricant manufacturers as well, resulting in bad press for Wet but higher lubricant-industry standards overall.

"Wet has contained a minimum of 1 percent nonoxynol-9 since the manufacturing of lot No. 1170," asserts Trygstad. He confirms that at the time of the voluntary recall of defective Wet batches in early 1992, "We changed to a new formulator who has been doing an excellent job. All of the old formula was replaced by the new formula, at no charge to the retail outlets or distributors." From February 1992 until March 1993, however -- batches 1148 to 1170 -- Wet contained only 0.1 per cent nonoxynol-9.

Currently most lubricants -- including Wet Personal Lubricant -- contain at least 1 percent nonoxynol-9, the concentration considered protective against HIV. But buyers still won't be able to read the exact ingredient proportions. And despite Trygstad's written assurances, no one -- not the manufacturer nor state or federal officials can absolutely verify that store owners have removed from their shelves Wet samples issued between February 1992 and March 1993. Nor can anyone say how many people bought and used or still have those samples.

"The consumer has been left in the dark by the national health watch dog, and that is unacceptable," fumes Dr. Taylor. Barbara Garcia, an HIV educator with Planned Parenthood in the Bay Area who has counseled over 100 HIV-positive women, agrees: "The word is not out about nonoxynol-9. The only way I learned about the irritation caused by nonoxynol-9 was by listening to the women I work with."

For now the daunting question Bird raised more than two years ago remains troubling: Can the minor toxicities associated with nonoxynol-9 in sexual products increase one's risk of HIV infection? At the FDA the anonymous executive defends his agency's inaction: "When we had people get sick and die from bad meat, we could put E. coli under the microscope and see it. With HIV and STDs and lubricants and nonoxynol-9, there's no way to know something for over 10 years, if someone seroconverted because they used only a lubricant with nonoxynol-9." Stuck in the gap between a drug and a cosmetic, he adds, "lubricants with nonoxynol-9, therapeutic doses, intended uses . . . these are just ethereal concepts in the FDA's eye."

The current demand for a vaginal microbicide may spur government officials into action. Already a private epidemiologist in Research Triangle Park, North Carolina, has proposed a clinical trial of nonoxynol-9 involving 1,000 women to determine its safety in contraceptives.

With the jury still out on nonoxynol-9, AIDS activists do have a simple word of advice for consumers regarding lubricants: Don't take a chance. Always use a condom.

Bohdan Zachary is a San Francisco-based journalist and Emmy Award-winning television news producer.

VIRUSMYTH HOMEPAGE