A politically charged debate about labeling condoms with warnings about the link between human papillomavirus (HPV) and cervical cancer has erupted following a related Congressional hearing on the issue in March. Although the dispute centers on the protection of women from cervical cancer, the debate is just as much about ideology: premarital abstinence or monogamy in marriage versus condom use for those who choose to be sexually active.
The hearings, called by Rep. Mark Souder (R-Ind.) at the urging of Tom Coburn, M.D., co-chair of the Presidential Advisory Committee on HIV/AIDS, continue to raise questions about a public law Coburn authored in 2000 and that former President Bill Clinton signed days before leaving office. Souder confronted the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention with his belief that the agencies had not complied with the public law.
Public Law 106-554 requires the CDC and the FDA to inform the public about "the effectiveness of condoms to protect against HPV" and "to determine if condom labels are medically accurate."
Condoms are classified by the FDA as Class II medical devices. Current FDA guidance documents recommend that condom manufacturers include a statement on the package insert that condoms may reduce the risk of transmission of HIV and many other sexually transmitted diseases (STDs). However, there has been no mandate to include information about HPV specifically.
"The scientific evidence is clear that condoms provide little protection from infection by HPV. Yet agencies and organizations are fighting to keep that fact from the public," Rep. Dave Weldon (R-Fla.), also a family physician, said at the hearing.
But a report published in January and testimony given at the March hearing raise the point that there is insufficient data available on just how HPV is spread and therefore how effective condoms can be as protection against the virus.
According to the CDC's Report to Congress: Prevention of Genital Human Papillomavirus Infection, the published epidemiology studies of HPV have methodologic limitations that make it difficult to interpret the true effect of condoms in the prevention of HPV transmission. "The available scientific evidence is not sufficient to recommend condoms as a primary prevention strategy for the prevention of genital HPV infection," the report concluded. However, it also states, "available studies suggest that condoms reduce the risk of clinically important outcomes of genital warts and cervical cancer."
Because condoms do not cover all areas where HPV manifests itself, they may not provide the same protection as they do against STDs transmitted though bodily fluids, such as HIV or gonorrhea, Daniel Schultz, M.D., director of the FDA's Office of Device Evaluation, said at the hearing. These same factors also limit the ability to properly conduct well-controlled clinical studies that are necessary to more clearly determine condom effectiveness.
The methodologic limitations of HPV studies have left an opening for some organizations already in favor of abstinence to conclude that condom use should not be recommended.
"Inattention to abstinence as a positive public health approach is only a symptom of a larger, more troubling phenomenon, a phenomenon that places science behind politics and social agendas," Weldon said at the hearing.
Public health officials, doctors, and health educators who are responsible for informing patients about STD prevention have had some difficulty finding the appropriate language to use when counseling people in this interim period before more conclusive research is available or the CDC and the FDA publish recommendations.
Many individuals and institutions actively involved in health policysuch as Rep. Henry Waxman (D-Calif.), Planned Parenthood, and Jeff Spieler, Ph.D., chief of the Research, Technology, and Utilization Division of the Bureau for Global Health, U.S. Agency for International Development (USAID)have expressed concern that people who choose to be sexually active will stop using condoms if they cannot easily understand new sex education messages, risk factors, and effective methods of prevention for various STDs, including HPV.
"What's needed is better data on condoms. There are no good studies. There is no conclusive evidence," said Spieler, who was part of a committee of representatives from the National Institutes of Health, CDC, FDA, and USAID that produced a report on condom effectiveness for STD prevention in July 2001.
At press time, the FDA said that the agency is still preparing a document that will offer guidance on condom labeling with regard to STD transmission. The agency reports that it is working to present a balanced view, being careful neither to encourage condom use in circumstances where it may not be medically appropriate nor to discourage condom use in circumstances where it is.
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