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Dr. Coburn Says New FDA Condom Regulations Make Inconclusive, Exaggerated Claims About Condom Effectiveness

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Location: Washington, DC


Dr. Coburn Says New FDA Condom Regulations Make Inconclusive, Exaggerated Claims About Condom Effectiveness

U.S. Senator Tom Coburn, M.D. (R-OK) released the following statement today regarding the release of new condom label guidance by the Food and Drug Administration (FDA):
"As a practicing physician, I believe informed consent is an integral component of empowering patients to make decisions that will impact their health. The new guidance for condom labels issued today by the Food and Drug Administration (FDA) recognizes that current condom label claims do not meet this medical standard. While I am encouraged that the FDA finally has recognized the inaccurate claims about contraceptives containing nonoxynol-9 (N-9) and the exaggerated claims of condom protection against sexually transmitted diseases (STDs), the agency continues to promote inconclusive assurances that put women unknowingly at risk for cervical cancer, or worse."

"Americans expect that product health claims are medically accurate, but this has not been the case with condom labels. Condoms have never undergone FDA approved clinical trials to demonstrate safety and effectiveness in protecting against STDs and the FDA has long refused to use its authority to ensure the scientific accuracy of condom claims. As a result, Congress was forced to pass a law directing the FDA to ensure that condom labels are medically accurate regarding their overall effectiveness and lack of effectiveness against sexually transmitted diseases (STDs), specifically human papillomavirus (HPV) which is the cause of nearly all cervical cancer."

"It has taken the FDA five years to issue these simple guidance regulations for condom labels, despite the fact that the scientific consensus has long recognized that condoms do not provide effective protection against HPV and provide less protection against STDs spread through contact outside the area covered by a condom. While the new guidance should ensure condom labels are more medically accurate by toning down the claims of protection, FDA still embraces some inconclusive and exaggerated claims of condom effectiveness."

"The FDA guidance, for example, claims condoms ‘may' provide protection against cervical cancer. This is speculation rather than scientific fact and is misleading. According to the Centers for Disease Control and Prevention (CDC), of all the available science examining HPV, only two studies have ‘statistically significant' results to support this claim. Furthermore, a meta-analysis of ‘the best available data describing the relationship between condoms and HPV-related conditions' from the previous two decades published November 2002 in the journal Sexually Transmitted Diseases concluded ‘There was no consistent evidence of a protective effect of condom use on HPV DNA detection, and in some studies, condom use was associated with a slightly increased risk for these lesions.' Clearly, the claim by the FDA that condoms may protect against cervical cancer is not a conclusive scientific fact and is therefore inappropriate, and potentially dangerous to the millions of women who rely on the FDA to ensure health claims are accurate. Such claims of protection should not be made without conclusive scientific data.

"In the five years it took the FDA to implement this law, over 27 million Americans have become infected with HPV, over 50,000 women have been diagnosed with invasive cervical cancer, and nearly 20,000 women have died from the disease. Despite these tragic numbers, very few Americans are still not aware of HPV or its link to cervical cancer and the FDA seems to be content with providing inconclusive claims of effectiveness that may endanger women be providing a false security against cervical cancer.

"Today's misleading recommendations by the FDA are the latest example where the agency has put the public at risk by providing inaccurate information about condoms. Earlier this year, the non-partisan Government Accountability Office (GAO) found that ‘the public may be at risk' because the FDA ignored scientific data that condoms and other contraceptives containing the spermicide nonoxynol-9 (N-9) increase HIV infection risk and actually recommended their use for HIV prevention. The new FDA recommendations finally correct this medically inaccurate and dangerous claim that the agency has long made regarding N-9.

"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. As the FDA correctly notes in the new guidance, ‘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'"

http://coburn.senate.gov/index.cfm?FuseAction=News.PressReleases&month=11&year=2005&id=170

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