Nonoxynol-9: Better Safe Than Sorry?
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 Iymphocytes 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 3articles 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, whileadmitting 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 asimilar 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.