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Gynecologic Cancer Education and Awareness Act of 2005

Location: Washington, DC



Mr. COBURN. Mr. President, as a physician and a two-time cancer survivor, I believe that eliminating cancer should be among our Nation's highest priorities.

During my two decades practicing medicine, I have treated countless patients of all ages and backgrounds who were diagnosed with various forms of cancers. Many were successfully treated and are alive and healthy today. Others were not as fortunate. Sadly, most of these cases could have been treated if detected earlier. Nearly all could have been prevented.

As a physician, I know firsthand that both patients and health care providers are not properly informed about many symptoms and causes of cancer. I have long been disappointed that the U.S. Surgeon General and the Centers for Disease Control and Prevention, CDC, have failed to take an effective leadership role to educate the American people with lifesaving information about the various forms of cancer and how to protect themselves. As a result, the American Cancer Society estimates that 1,399,790 men and women--720,280 men and 679,510 women--will be diagnosed with and 564,830 men and women will die of cancer of all sites in 2006. Countless others will require invasive treatment that will forever affect their lives.

Each of these individual lives represents a failure to protect the health of one of our sisters, daughters, brothers, sons, parents, neighbors, and friends.

One recent patient of mine, an 18-year-old girl, is an example. She was diagnosed with human papillomavirus, HPV, infection. HPV is the cause of over 99 percent of all cervical cancers and is a sexually transmitted disease.

To prevent the onset of invasive cervical cancer, a large portion of this young girl's cervix had to be removed. As a result she is less likely to be able to become pregnant in the future and more likely to have a premature infant if she does become pregnant. And despite already undergoing invasive treatment, she remains at risk for future complications and additional surgeries.

This girl and the others that I am caring for in my medical practice are the real faces of those affected by HPV and cervical cancer. What we are confronting is not an isolated epidemic.

About 24 million Americans are currently infected with HPV according to the National Cancer Institute and an estimated 5.5 million Americans become infected with HPV every year. With 4.6 million of these HPV infections acquired by those aged 15 to 24, HPV accounts for over half of all new sexually transmitted diseases among young Americans. On March 8, 2004, researchers from the Colorado Health Sciences Center reported that more than 30 percent of women in a recent study were found to be infected with a strain of HPV linked to cervical and anal cancer. In comparison, 18.7 percent of men carried HPV-16, one of 10 high-risk strains of the virus.

Over 1,350,000 women will have invasive procedures each year just to assess the status of their abnormal pap smears secondary to HPV. According to the American Cancer Society, every year over 12,000 new cases of invasive cervical cancer are diagnosed and more than 4,000 women die of the disease. And noninvasive cervical cancer is estimated to be four times as widespread as the invasive type. HPV is also associated with other forms of cancer and more than 1 million precancerous lesions that affect both women and men.

Few of my patients with HPV had ever heard of the virus and were unaware of its health risks including its link to cancer. Many of my fellow physicians were not even aware of HPV and its symptoms.

In 2000, I authored legislation directing the CDC and the Food and Drug Administration--FDA--to take actions to educate the public with ``medically accurate information'' about HPV and cervical cancer. I was disappointed when groups that claimed to advocate for women's health, such as the American College of Obstetricians and Gynecologists--ACOG--opposed my proposal and fought to keep the public in the dark about HPV.

The HPV law was approved by Congress as a component of the Consolidated Appropriations Act of 2001 and became Public Law 106-554 with the signature of President Bill Clinton on December 21, 2000. In a Statement of Administration policy, President Clinton stated:

The Administration supports the goal of better informing the public about HPV and the fact that the use of condoms may not fully prevent HPV transmission.

The law directed CDC to develop a report outlining the ``best strategies to prevent future infections, based on the available science.'' After the repeated urging of Congress, CDC finally issued a report in 2004 that concluded:

Because genital HPV infection is most common in men and women who have had multiple sex partners, abstaining from sexual activity (i.e. refraining from any genital contact with another individual) is the surest way to prevent infection. For those who choose to be sexually active, a monogamous relationship with an uninfected partner is the strategy most likely to prevent future genital HPV infections. For those who choose to be sexually active but who are not in a monogamous relationship, reducing the number of sexual partners and choosing a partner less likely to be infected may reduce the risk of genital HPV infection.......

The available scientific evidence is not sufficient to recommend condoms as a primary prevention strategy for the prevention of genital HPV infection.......

Regarding other possible prevention approaches, no data indicate that treatment of clinical lesions or use of microbicides will prevent transmission of infection, although HPV vaccines are likely to become available in the next few years and may become an effective prevention tool.

The CDC's conclusions reflected what has become the scientific consensus.

In a February 1999 letter to the U.S. House Commerce Committee, Dr. Richard D. Klausner, then-Director of the National Cancer Institute, stated:

Condoms are ineffective against HPV because the virus is prevalent not only in the mucosal tissue (genitalia) but also on dry skin of the surrounding abdomen and groin, and it can migrate from those areas into the vagina and the cervix. Additional research efforts by NCI on the effectiveness of condoms in preventing HPV transmission are not warranted.

In 2001, the National Institute of Allergy and Infectious Diseases along with FDA, CDC and the U.S. Agency for International Development issued a consensus report regarding condom effectiveness that concluded ``there was no epidemiologic evidence that condom use reduced the risk of HPV infection.''

In November 2002, a meta-analysis of ``the best available data describing the relationship between condoms and HPV-related conditions'' from the previous two decades was published in the journal Sexually Transmitted Diseases. The meta-analysis 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.''

Based upon these findings, the law directs CDC to ``prepare and distribute educational materials for health care providers and the public that include information on HPV. Such materials shall address modes of transmission, consequences of infection, including the link between HPV and cervical cancer, the available scientific evidence on the effectiveness or lack of effectiveness of condoms in preventing infection with HPV, and the importance of regular Pap smears, and other diagnostics for early intervention and prevention of cervical cancer.'' The CDC has not complied with this requirement.

The law further requires that ``all other relevant educational and prevention materials prepared and printed from this date forward for the public and health care providers by the Secretary--including materials prepared through the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration--or by contractors, grantees, or subgrantees thereof, that are specifically designed to address STDs including HPV shall contain medically accurate information regarding the effectiveness or lack of effectiveness of condoms in preventing the STD the materials are designed to address.'' Again, Federal agencies have not complied with this provision of law.

The law directed the FDA ``to determine whether the labels are medically accurate regarding the overall effectiveness or lack of effectiveness of condoms in preventing sexually transmitted diseases, including HPV.'' Six years after this law was signed, the FDA is still in the beginning stages of crafting a new medically accurate informational label for condom packages. By way of comparison, it took 410 days to build the Empire State Building and 2 years, 2 months and 5 days to construct the Eiffle Tower.

Congress approved the HPV law precisely because Federal health agencies had failed to educate the American public about the health risks of HPV and how it can be prevented and these same agencies are continuing their cover-up of the HPV epidemic, now in violation of federal law.

In 1999, when this law was first offered in Congress, a study published by the American Journal of Preventive Medicine in June 1999, found that ``only 37 percent of respondents had ever heard of HPV,'' meaning knowledge of HPV has not increased in almost a decade. The 1999 study concluded ``implementing HPV education programs and measuring their effectiveness should be a priority.''

According to a 2005 Health Information National Trends Survey, only 40 percent of women have ever heard about HPV. Of those that have heard of HPV, less than 20 percent knew that HPV could sometimes lead to cervical cancer, meaning that only about 8 percent of American women are aware that HPV can cause cervical cancer. The only factors associated with having accurate knowledge--knowing that it could lead to cervical cancer--was an abnormal Pap test or testing positive on an HPV test. This suggests that most women are finding out about HPV only after experiencing a negative consequence.

As these numbers show, the failure of CDC and FDA to enact the HPV/cervical cancer education and prevention law has had real consequences--a hidden epidemic that claims thousands of lives every year and affects tens of millions of others.

It is unacceptable that federal health agencies have abdicated their responsibility and missions and intentionally ignored the law and, in so doing, placed the health and lives of millions in jeopardy.

Today the Senate has passed another bill, the Gynecologic Cancer Education and Awareness Act, or ``Johanna's Law,'' which will again direct CDC and FDA to educate the public about cervical cancer as well as other forms of gynecological cancer.

I would like to recognize Senator Arlen Specter, Congressman Darrell Issa, cancer survivor Fran Drescher, and the countless other activists who are cancer survivors themselves or have a loved one who has been diagnosed with gynecological cancer who have championed this bill through Congress.

It is an unfortunate statement that this bill is even necessary. It is a recognition that federal health agencies have failed to effectively carry out their missions.

It was my concern that the same agencies entrusted with enacting this bill would ignore it in the same manner that the law Congress passed in 2000 has been ignored. That would mean that the dedication and hard work of the activists and survivors who supported this bill was for nothing.

When I voiced these concerns, Senator Specter agreed to amend the bill language to include a date certain that the cancer education activities that both this bill and the current law require. This assures that the law and the epidemic of gynecological and cervical cancer can no longer be ignored by federal agencies.

If the CDC and the FDA do not enact the provisions of this bill and the existing law--317P of the Public Health Service Act--by March 1, 2008, the Department of Health and Human Services is required to submit to Congress a ``a detailed description of all actions taken'' to bring the Department into compliance every three months until the law has been fully enacted.

I fully expect that these requirements will compel CDC and FDA to enact these important laws and the Department will not deliver ``the dog ate my homework'' excuses. Laws, after all, are not optional for citizens, for members of Congress or even for government agencies and bureaucrats.

Again, I am pleased that the Senate is directing federal health agencies to do their part to help educate and prevent gynecological and cervical cancer and that this time we will hold them accountable to ensure that not another one of our sisters, daughters, mothers, or friends falls victim to this silent epidemic.

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