Download The Facts and the Debate - June 2004

June 2004
U.S. Congressional Confusion on N-9:
The Facts and the Debate
For more information, contact Anna Forbes - +1 202 822 0033, [email protected]
What has Congress done re: Nonoxynol -9?
In 2003, safety issues related to nonoxynol-9 (N-9) captured the attention of Roland Foster, a staff
member to Rep. Mark Souder (R-IN), chair of the House Government Reform Committee Criminal
Justice, Drug Policy and Human Resources. Both are active opponents of family planning, as well as
condom skeptics. Earlier this year, Rep. Souder held a hearing in his subcommittee in which he urged
the FDA to relabel condoms to indicate that they do not protect against human papillomavirus, an effort
generally regarded as misguided by public health advocates.
In a similar vein, on February 26, 2004 the House Government Reform Committee approved by voice
vote a document requesting the Budget Committee to include language in the FY 2005 Budget
Resolution urging the FDA to require warning labels on all products containing the spermicide N-9.
And on March 18, the subcommittee on Criminal Justice, Drug Policy and Human Resources sent an
inquiry to the FDA requesting that the agency pull N-9 products from the market until the safety and
effectiveness of N-9 use can be proven.
While public health advocates (including the WHO and CDC) agree that N-9 is unsafe for rectal use,
vaginal contraceptive products containing N-9 remain a viable contraceptive option for women at low
risk of HIV who do not engage in multiple acts of intercourse in one day. The subcommittee’s request
to the FDA mixes evidence about the contraceptive uses of the product with its track record as an
HIV/STD prevention method and misrepresents the potential risks of product use.
If Foster’s recommendations were to be accepted, the consequences would be problematic for users of
many safe, effective contraceptive products (including diaphragms and cervical caps), which are labeled
for use with a spermicide.
What is Nonoxynol-9?
Nonoxynol-9 (N-9) is the active ingredient in virtually all over-the-counter spermicides on the market
today in the United States. It has been used over the last half-century in a wide range of products
including vaginal gels, creams, foams, suppositories, sponges, and films, used alone or with other
contraceptive devices, such as the diaphragm or cervical cap. N-9 works by disrupting cell membranes,
including those of sperm cells. When in vitro studies in the 1980s demonstrated that N-9 also kills HIV,
researchers began to study its potential as a vaginal microbicide.
The practice of adding N-9 to condoms and sexual lubricants accelerated in the early 1990s in response
to the belief that it might provided some protection against bacterial STDs and possibly HIV. In 2000,
however, researchers demonstrated conclusively that N-9 was not effective in reducing
HIV transmission. When used in the vagina multiple times a day, contraceptive products containing N-9
can cause disruption of the vaginal epithelium (cell wall) – a condition that may increase a woman’s risk
of becoming infected with HIV, if exposed. Low, infrequent doses of N-9 (once a day or less), however,
appear to cause little or no disruption of the vaginal epithelium.
In August 2000, the CDC strongly recommended against using N-9 products for HIV or STD
prevention. Recent studies also show that the damage associated with rectal use of N-9 products is
generally far more extensive and worrisome than that observed with vaginal use of the same products.
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N-9 and condoms
As noted above, N-9 has been added to several brands of lubricated male condoms over the last
decade. However, no evidence exists that N-9 lubricated condoms provide greater contraceptive
efficacy than condoms lubricated without N-9. Since N-9 coated condoms do not offer any proven
contraceptive benefit but do pose the risk of harm if used rectally, advocates agreed that there was a
clear public health need to discontinue the addition of N-9 to products that could be used rectally, such
as condoms and lubricants.
In order to get the word out, the Global Campaign for Microbicides launched a call in September 2002
to discontinue N-9 for rectal use and urged manufacturers of condoms and sexual lubricants to stop
adding N-9 to their products. Virtually all lubricant manufacturers and several condom manufacturers,
including Durex, complied with this request and have stopped production of N-9 containing condoms
and lubricants.
What is the latest research on N-9 for vaginal use?
Vaginal use of N-9 contraceptive products (used alone or with a diaphragm or cervical cap) offer an
important option for women who choose not to use hormonal birth control methods and are at low
risk for HIV and STDs. Women who have multiple daily acts of intercourse, however, should be advised
to choose another method of contraception.
New data on the efficacy and safety of N-9 as a contraceptive was published in the March 2004 issue of
the Journal of Obstetrics and Gynecology. The journal reported on a study sponsored by NICHD
comparing the effectiveness and safety of five spermicides. The study grew out of a 1995 proposed rule
from the FDA to require spermicide manufacturers to submit data demonstrating the contraceptive
effectiveness of each marketed spermicide product in order for the product to remain on the market.
This rule has not yet been finalized.
The study enrolled approximately 1500 sexually active women aged 18-40 who wished to rely on a
spermicide as their only contraceptive method for seven months. It compared three gels containing
varying doses of N-9 (52.5 mg, 100 mg. and 150 mg.), as well as a film and a suppository, each containing
100 mg of N-9 per dose. The study found that the gel with the lowest amount of N-9 was less effective
than the two higher dose gels, with 22 percent of the women using the lowest dose becoming pregnant
over 6 months. For the two higher doses, pregnancy rates were significantly less. Fourteen percent of
the women in the 100 mg. gel group became pregnant, as compared to 12 percent in the film group and
10 percent in the suppository group.
FDA and Labeling of Contraceptive Products Containing N-9
On January 16, 2003, the Food and Drug Administration (FDA) proposed new warning label statements
for all over-the-counter (OTC) vaginal contraceptive drug products containing N-9. The FDA proposed
to advise consumers that vaginal contraceptives containing N-9 do not protect against HIV or sexually
transmitted diseases (STDs). The new warning label further proposed to advise consumers that frequent
use of vaginal contraceptives containing N-9 could increase vaginal irritation. Increased vaginal irritation
from use of N-9 may heighten the possibility of transmission of the AIDS virus (HIV) and STDs from
infected partners. The agency requested public comment on the proposed labeling statements and how
such information could best be presented in labeling.
Many groups that focus on women’s health, microbicides, AIDS and STDs, submitted comments
suggesting that the label clarify that rectal use is harmful. Many also pointed out that it was important to
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ensure the continued availability of N-9-containing contraceptive products to women at low risk for
STDs and HIV – at least until alternative spermicides/microbicides are developed.
What are the appropriate public health messages?
 An across-the-board ban on N-9 is not recommended.
 N-9 containing products should never be used rectally (in either condoms or lubricants).
 N-9 is not effective at preventing the transmission of HIV or other sexually transmitted diseases
(STDs) and may even increase the risk of HIV infection in women using these products frequently.
 Condom manufacturers who have not voluntarily discontinued their production of N-9 condoms
should be pressured to do so.
 Vaginal use of N-9 contraceptive products (used alone or with a cervical cap) offer an important
option for women who choose not to use hormonal birth control methods, and are at low risk for
HIV and STDs.
 Women who have multiple daily acts of intercourse should be advised to choose another method of
contraception.
 Greater investments in microbicide development are needed. Microbicides are products designed to
be used vaginally or rectally to reduce the risk of getting infected with HIV and possibly other
STDs. They are being formulated as gels, creams, suppositories, etc. No approved microbicides are
yet available, although over 60 potential microbicides are in the research pipeline and 18 of them are
already in human testing.
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