The FDA wants
condom packages to warn that condoms are less effective at
stopping some sexually transmitted diseases, such as herpes
and human papillomavirus, than others. The agency also
wants packaging to advise that condoms that use a
common spermicidal lubricant should not be used by
people at risk of catching HIV.
In proposed rules
posted on its Web site, the Food and Drug
Administration said the changes to male condom labels would
provide people with more precise information on how
well condoms work. They would apply to latex condoms,
which make up about 98% of the market; rules for other
condoms are forthcoming.
The FDA would not
insist condom manufacturers use FDA-provided language,
but they would have to include the information in some form
on their packages. "More accurate information about
the risks and benefits of condom use with respect to
STD transmission can lead to better choices by
individuals who seek to protect themselves against these
infections and potentially to reduced transfer of
STDs," the FDA said.
Condom packages
now generally note they are effective in reducing the
chance of pregnancy and getting an STD, particularly HIV,
from intercourse. Under the proposed rules, condom
packages would say that they are thought to be less
effective against certain STDs, including herpes and
human papillomavirus, because those diseases can be
transmitted through skin-to-skin contact in places not
covered by a condom. However, studies have shown
condom use does reduce the chances of a person
suffering from some of the worst effects of human
papillomavirus, or HPV, which include genital warts and
cervical cancer.
In addition,
packages of condoms that use nonoxynol-9, which kills sperm,
would come with a recommendation that they should not be
used by people at risk of catching HIV, the virus that
causes AIDS. The spermicide can irritate the vagina or
rectum, leading to a greater chance that HIV can be
transmitted from an infected partner. Packages of condoms
with nonoxynol-9 already include a statement noting
that the extent of the chemical's effectiveness
in decreasing the risk of pregnancy beyond that of the
condom itself is uncertain.
The FDA
considered, and discarded, suggestions to include social or
public health-related advice on condom packages, the
agency said. Some activists had worried the FDA would
propose far greater changes to current guidelines and
exaggerate the failure rate of condoms in accordance
with the wishes of some social conservatives. But that
didn't happen. "I would hope that the clarifying
language marks the start of a real commitment to
educating the American public about the importance of
condom use--and public-health programs to help people
use them correctly and consistently," said Julie
Davids, executive director, of the Community HIV/AIDS
Mobilization Project. She commended FDA "for sticking
to sound public health rather than scare tactics."
The FDA said the
financial impact on manufacturers to change their labels
would be minimal. A spokeswoman for the Trojan brand of
condoms said the company was reviewing the guidelines
but declined to discuss them further. The proposed
rules are the result of a review mandated by Congress
in 2000. Sen. Tom Coburn (R-Okla.) said the proposed
language falls far short. "While I am encouraged that
the FDA finally has recognized the inaccurate claims
about contraceptives containing nonoxynol-9 and the
exaggerated claims of condom protection against
sexually transmitted diseases, the agency continues to
promote inconclusive assurances that put women
unknowingly at risk for cervical cancer, or worse," he
said.
Coburn, a
physician, dismissed the notion that condoms protect against
cervical cancer as speculation, saying there wasn't enough
science to prove it. "The FDA should stop playing
political games with the health and lives of Americans
and immediately comply with the law by ensuring only
medically accurate information that is irrefutable on
condom labels," he said.
When latex
condoms are used every time and put on early enough to
prevent insemination, they reduce chances of pregnancy
over a one-year period to 3%, compared with 85%
without birth control. Likewise, condoms cut risk of
HIV infection by about 80%, to less than a 1% chance of
infection per year. According to the National
Institutes of Health, condoms are impermeable to the
smallest viruses and only break or slip off 1% to 2%
of the time. But surveys show people don't always use them
properly or consistently. Roughly 12 million Americans
each year contract an STD. Once published in the
Federal Register--expected in the coming
days--the rules will be open to 90 days of
public comment. (AP)