PRNewswire - November 14, 2005

Allen's remarks come in response to the slated November 14 release of a new Food and Drug Administration (FDA) guidance on condom labeling. ASHA is a 91-year-old national nonprofit focused on prevention of sexually transmitted infections (STIs).

"Over the past decade, the utility of condoms for STI prevention has been challenged on the basis of ill-founded concerns that condom promotion might paradoxically encourage risky behaviors," says Edward W. Hook, III, MD, a member of the ASHA Board of Directors and professor of medicine at the University of Alabama-Birmingham.

In a statement to HHS Secretary Leavitt in early October, ASHA stressed that the long-anticipated guidance should be based on a review of the scientific literature and not overly influenced by political pressure to downplay condom effectiveness.

FDA's language regarding human papillomavirus (HPV) infection was expected to be especially controversial. The agency was under pressure to characterize condoms as being totally ineffective against HPV, an STI estimated to affect more than 50% of sexually active adults at some point. While initial HPV infection usually causes no signs or symptoms, certain types of HPV create an increased risk of cervical cancer.

In the end, however, the FDA issued a nuanced statement about the role of condoms in HPV prevention, stating that consistent condom use can "lower the risk" of developing HPV-related disease.

"The FDA is correct that condoms provide differing levels of protection for different infections," says Allen. "But the bottom line is condoms are currently the best product available to protect sexually active people from STIs, including HIV."

"For all STIs, including HPV," Allen adds, "there is a reason to use condoms. The evidence shows condoms reduce the risk of the worst outcomes of HPV infection - genital warts and cervical cancer."

"Every day, we field questions from the public on sexual health," says Allen, "and we know that questions about risk reduction for STIs are at the top of the list. While we find the new FDA guidance is based in scientific literature, we will be recommending refinements."

ASHA has concerns that the proposed language may be overly complex in some areas and would benefit from simpler wording and a lower reading level. Equally important, ASHA continues to urge FDA to consider new data showing that condom use is associated with a reduced risk of acquiring HPV infection. Additional research on condoms in the prevention of genital herpes will also be published in the coming months.

SOURCE American Social Health Association

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