Federal plan to label condoms comes under fire

October 2004

BOSTON — Condom labeling describing the link between human papillomavirus (HPV) and cervical cancer and questioning the efficacy of condoms in preventing HPV infection might send youth a mixed message about the effectiveness of condoms in preventing sexually transmitted infections (STIs), according to King K. Holmes, MD, PhD, the Maxwell Finland lecturer at the 42nd Annual Meeting of the Infectious Diseases Society of America.

The FDA is preparing a document intended to guide such labeling. The document comes in response to congressional hearings earlier this year, during which the CDC was criticized for missing a deadline for submitting a report to Congress entitled “Prevention of Genital Human Papillomavirus.”

Following those hearings, the CDC submitted revised HIV content guidelines in the Federal Register, to include wording that emphasized section 317P of the Public Health Service Act. The act requires the agencies to inform the public about “the effectiveness or lack of effectiveness of condoms in preventing the STI the materials are designed to address” in AIDS-related materials and CDC school-based sexual education assistance programs.

Holmes, of the University of Washington Center for AIDS and Sexually Transmitted Diseases in Seattle, took aim at political pressures on both the CDC and the FDA, charging they were being asked to send “mixed messages” to youth, who could misinterpret labels on condoms as questioning their overall efficacy against HIV and other STIs.

Efficacy rates

Holmes proceeded to review several studies that showed efficacy rates of 80% to 95% in preventing HIV and high success rates in reducing incidence of other STIs as well. The FDA document would provide guidance specifically on HPV and cervical cancer risk. Ed Thompson, MD, chief of public health practice at the CDC, told Infectious Disease News after the meeting that there is insufficient data to recommend condoms as a primary prevention strategy against HPV.

Consistent condom use was 80% to 95% effective at preventing HIV, according to three large studies.

Holmes said that the most recent data from a randomized trial of condom use and from the first study designed to carefully examine prospectively the effectiveness of condoms in protecting women from acquiring HPV infection do suggest protection. These data do not suggest any lack of efficacy against HPV that would warrant condom labeling.

For example, the randomized trial was carried out recently in the Netherlands. Women with precancerous disease of the cervix — most with HPV infection — were randomly assigned to always use condoms or to not use condoms during sex. The study showed significantly faster spontaneous disappearance of their cervical dysplasia and significantly more frequent disappearance of the associated HPV infection, among those assigned to use condoms.

Furthermore, Holmes mentioned a study in progress in Seattle, led by Laura Koutsky and pre-doctoral student Rachel Winer, in which college women keep Web-based diaries on when they have had sex and whether they used condoms. The study so far is showing consistent, correct condom use is associated with substantially lowered risk of acquiring cervical HPV infection.

According to Holmes, the accumulated data from a growing number of studies now support condoms’ efficacy in warding off virtually all bacterial, viral or protozoal STIs that have been studied.

For example, a study by Sanchez et al looked at female sex workers in Peru using condoms and found a greater than 50% reduction in the rate of women contracting gonorrhea, as well as a statistically significant reduction in the incidence of chlamydial infection and vaginal trichomoniasis. A recent study in the United States by Warner et al of men and women known to have been exposed to gonorrhea or chlamydial infection also showed that those who reported consistent use of condoms had substantially reduced risk of acquiring either of these infections. Three large meta-analysis of prospective studies of HIV serodiscordant couples showed that consistent condom use was 80% to 95% effective at preventing HIV.

John Farnham, with the FDA, told Infectious Disease News after the meeting that current labeling emphasizes that when used properly, latex condoms will help to reduce the risk of transmission of HIV infection and many other STIs, including chlamydia, herpes, genital warts, gonorrhea, hepatitis B and syphilis.

But he said the issue of HPV is not addressed in current labels, and the FDA is working diligently to craft language that “conveys the limitations of condoms while not destroying their credibility for preventing diseases transmitted through secretions.”

Some organizations, like the Physician’s Consortium, charge that condom promotion has caused a false sense of security and point to studies like one led by Joanna Mohn, MD, that demonstrated a drop in teen pregnancy due to an emphasis on abstinence.

That study, published in the journal Adolescent and Family Health, viewed recent drops in teen pregnancy rates as teens heeding the message of abstinence education. However, other randomized trials of abstinence-only programs have showed no reduction in unintended teen pregnancy. (BMJ. 2002;224:1426.)

Holmes countered that “the challenge of behavioral interventions has been maintaining that change over time.”

He said one randomized control trial looked at behavioral interventions (including core counseling and maintenance sessions) to prevent acquisition of HIV infection by men who have sex with men. It was launched in six United States cities and studied more than 4,000 men, but found only a model (16%) reduction in HIV incidence in the intervention group, which was not statistically significant.

“During the first 12 months there appeared to be a transient decrease in HIV incidence in the intervention group, but further follow-up showed no difference in incidence between intervention and control groups during the second, third and fourth years of the study,” he said. “The sustainability of the interventions to prevent STIs has generally been short, and it may explain why some have been effective and some haven’t.”

For more information:

• Holmes K. Randomized trials of HIV/STI prevention: what has worked, what hasn’t and why. Plenary session 27. Presented at the 42nd Annual Meeting of the Infectious Diseases Society of America. Sept. 30-Oct. 3, 2004. Boston.
• CDC. Interim HIV content guidelines for AIDS-related materials, pictorials, audiovisuals, questionnaires, survey instruments, marketing, advertising and web site materials, and educational sessions in CDC school-based assistance programs. Federal Register. 2004;69(115):33826.
• For the CDC’s report on HPV, see, www.cdc.gov/nchstp/dstd/HPVInfo.htm.