The House Government Reform Subcommittee on Criminal Justice, Drug Policy, and Human Resources held a March 11 hearing to examine the latest science regarding cervical cancer and human papillomavirus (HPV). Chair Mark Souder (R-IN) noted that roughly 20 million Americans are infected with HPV, and an “estimated 5.5 million Americans become infected with HPV every year and 4.6 million of these are acquired by young Americans between the ages of 15 and 24.” Adding that experts agree that infection with certain strains of HPV can lead to cervical cancer, Rep. Souder said, “Because deaths from cervical cancer are largely preventable, it is vitally important that women have access to and are routinely screened for HPV and cervical cancer.”
The subcommittee heard from a number of experts on the subject, including the various federal agencies charged with HPV surveillance, research, and education activities. Specifically, federal agencies addressed their efforts to implement P.L. 106-554, the Consolidated Appropriations Act of 2001. The law includes language directing several agencies to review the science of HPV and educate the public about the sexually transmitted disease (STD).
Dr. Ed Thompson detailed the Centers for Disease Control and Prevention’s (CDC) activities to address HPV infection, HPV disease, and cervical cancer. Referencing P.L. 106-554, which requires the CDC to conduct surveillance on HPV, research prevention strategies, and prepare and distribute educational materials on HPV, Dr. Thompson said that the CDC has initiated a number of activities, including:
Additionally, Dr. Thompson said that the CDC has “conducted laboratory research on clinical outcomes of HPV disease, prevalence and risk factors for HPV, biological markers of cervical cancer and HPV, and development of sensitive HPV diagnostic tools.” He also highlighted the National Breast and Cervical Cancer Early Detection Program, which provides cancer screenings for uninsured and underserved women. “To date, almost 1.75 million women have been screened,” he said, continuing, “The program has provided women with more than four million screening examinations, through which approximately 14,446 women with breast cancers, 55,210 women with precancerous cervical lesions, and 1,020 women with cervical cancers have been diagnosed. Fifty percent of the women screened are from racial/ethnic minority populations.”
Summarizing the research initiatives of the National Institutes of Health (NIH), Dr. Edward Trimble of the National Cancer Institute (NCI) said, “In fiscal year 2003, NCI spent $79 million for research on cervical cancer.” Dr. Trimble said that NCI scientists are: investigating why most adults exposed to HPV do not develop cancer or any other health problems as a result of the infection; developing a vaccine to prevent HPV infection, as well as a therapeutic vaccine to protect women already infected from developing cervical cancer; working to improve the reliability of Pap tests and evaluate new methods of screening for cervical cancer; improving the treatment for cervical cancer; and working to preserve the fertility of women diagnosed with cervical cancer.
Dr. Trimble noted several ongoing studies: the Guanacaste Study of HPV Natural History, the Genetic Supplementation Study, the Study to Understand Cervical Cancer Early Endpoints and Determinants (SUCCEED), the Alternatives to Women’s Health Care Immunology Study, the ASCUS/LSIL Triage/Study for Cervical Cancer (ALTS), the Portland Kaiser Cohort Study, a longitudinal study of HPV infection and cervical neoplasia in Sao Paulo, Brazil, and a vaccine trial. “In the future,” Dr. Trimble said, “The NCI plans to continue its close collaboration with its sister agencies in DHHS to make available effective vaccines for HPV to reduce the emotional and economic cost of screening for cervical cancer, to improve the accuracy of screening, and to find more effective treatment for cervical cancer.”
Dr. Daniel Schultz of the Food and Drug Administration (FDA) discussed his agency’s efforts to implement P.L. 106-554, which requires the Department of Health and Human Services to reexamine existing condom labels to determine whether they are medically accurate with respect to the effectiveness or lack of effectiveness of condoms in preventing STDs. “FDA has conducted an extensive literature and labeling review,” Dr. Schultz said. Based on that review, the FDA “has developed a regulatory plan to provide condom users with a consistent labeling message about STDs and the protection they should expect from condom use. FDA is preparing new guidance on condom labeling to address these issues, with the target of publishing that guidance as a draft for public comment later this year.”
Dr. Schultz added that the FDA is “committed to help bring safe and effective technologies to the market quickly,” pointing out that the agency approved the expanded use of an HPV DNA test for screening women over the age of 30 in March 2003. “In addition, the FDA’s Center for Biologics Evaluation and Research (CBER) is currently working with manufacturers to bring preventive HPV vaccines to market,” he said.
The subcommittee also heard from former Rep. Tom Coburn (R-OK), who is a practicing physician. Dr. Coburn was the author of the HPV language contained in P.L. 106-554. “I quickly learned that it would take more than passing a law to convince CDC and FDA to take action to educate the public about HPV,” he said. He stated that the CDC was two years late in providing a report to Congress on its efforts to implement the law, and that the CDC said it will not issue another report detailing findings on the best strategies to prevent future infections until 2007, “four years after the due date set by law.”
“Because of this continued resistance, I requested the Inspector General of the Department of Health and Human Services ‘conduct a thorough investigation to determine why P.L. 106-554 has been both misinterpreted and largely ignored by CDC and FDA,'” Dr. Coburn told the subcommittee. He recommended that the subcommittee continue its oversight to ensure that the agencies comply with the law. “With 4.6 million young people under the age of 25 expected to contract this disease, more than 4,000 women projected to die as a result of cervical cancer and up to $6 billion to be spent on HPV care all within a single year, turning back the HPV epidemic should be among the highest of CDC’s priorities,” he said.
Dr. Jonathan Zenilman of The Johns Hopkins University School of Medicine spoke of the need for what he called a “two-pronged approach” to thwarting the spread of HPV and other STDs. “Delaying sexual intercourse is a public health message that I and all reproductive health professionals support—in tandem with counseling on responsible sexual behavior,” he said. “An abstinence-only approach which excludes safer sex messages, and includes messages that emphasize intercourse only within the context of marriage is therefore clearly out of touch with the realities and practices of the vast majority of Americans.”
Pointing out that “condoms are highly effective in preventing sexually transmitted infections,” Dr. Zenilman said, “Current proposals to provide questionable warning labels and to undermine public confidence in condoms will not reduce the number of persons engaging in risky sexual behavior.” In discussing a 2001 NIH report on condom effectiveness, which stated that “the scientific evidence is not sufficient to recommend condoms as a primary prevention strategy for the prevention of genital HPV infection,” Dr. Zenilman said that the statement has been misinterpreted. “It does not say that condoms are ineffective, and in fact, there are promising data to suggest that they are…The same report noted that there is evidence that condom use may actually reduce the risk of cervical cancer.”
Dr. Thomas Cox agreed that sex education “must teach both the positives of abstinence until marriage and educate how best to minimize risk for the majority who will undoubtedly at some point choose otherwise.” Focusing much of his comments on screening for HPV and cervical cancer, Dr. Cox emphasized the need for an “all-out commitment by private and public payers to provide the best screening available for all women.” He said, “The majority of cervical cancers continue to occur in women receiving either no, or inadequate, cervical screening.”
Dr. Cox praised new screening guidelines issued in 2002, which recommend that cervical cancer screening begin at age 21 or within three years of first intercourse; that women up to age 30 have cervical cancer screening every two years if the new liquid-based Pap test is used; and that women over the age of 30 have a Pap test every two to three years if they have three consecutive abnormal results and every three years if their results are normal. “The war against HPV and cervical cancer will be won. All we have to do is hold the course steady by appropriately educating our youth, providing the best protective cervical screening available for all women, and providing HPV vaccines to all children once these vaccines become available,” he said.
