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A tough haul for cancer test

With a new vaccine on the market to prevent it and multimillion-dollar advertising campaigns highlighting it, the cervical-cancer-causing human papillomavirus - or HPV - might be the most talked-about sexually transmitted disease since HIV.

Yet a seven-year-old test designed to detect its most dangerous strains in women still isn't used in 4 out of the 5 gynecological exams it's approved for, according to Digene Corp., the Gaithersburg company that makes the test. And the recent attention to the virus has led other women to request the test when it isn't right for them.

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The lack of use may be putting women at risk of developing a preventable cancer, some health care workers fear, which has led to revamped medical guidelines and grass roots efforts to educate professionals and the public about the test.

"Sometimes the [full] information doesn't get out to everybody," said Susan Wysocki, president and chief executive of the National Association of Nurse Practitioners in Women's Health.

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Last week, her organization put out medical guidelines suggesting nurse practitioners take advantage of the HPV test where appropriate: as a follow-up cancer-screening method for women whose Pap smears show abnormal or inconclusive cervical cell changes, and as part of a primary care plan in women 30 and older.

The test shouldn't be an option for routine screening in younger women, however, because their HPV is likely to be harmless, Wysocki said. It's only the strains that stick around into a woman's 30s that cause concern, though most of those never become cancer.

"[HPV] is ubiquitous," Wysocki said. "If you get a positive in a young woman, what do you do with it? It's not necessarily a problem. Their own immune systems take care of it. ... [We want practitioners to] apply the technology appropriately."

Positive results in older women typically lead to closer patient monitoring.

According to the Centers for Disease Control and Prevention, 80 percent of the population will contract some form of HPV, which lives in the skin of mucous membranes, by age 50.

The virus has more than 100 strains, 30 of which are sexually transmitted and about a dozen of which can cause cancer to form on a woman's cervix. In men, the virus is typically more of a nuisance than a danger, often clearing on its own without ever showing symptoms.

Digene's HPV test is meant to identify the dangerous strains that linger in women's bodies for years.

The test is considered 99.9 percent accurate, compared with the Pap's 80 percent accuracy in finding cervical cell changes. And groups including the American Cancer Society, the American College of Obstetricians and Gynecologists and the American Society for Colposcopy and Cervical Pathology recommend the HPV test.

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Still, it's been a tough haul getting doctors to use it, Digene said.

"FDA approval of our test and the recommendation guidelines are the foundational ticket to the game, if you will, but that doesn't ensure that you're going to get the business," said C. Douglas White, who oversees Digene's commercial operations, including sales and marketing in the Americas and Asia Pacific.

"That's just the entry card to get to play."

Digene's biggest challenge, White said, has been in getting health care providers to change their mind-set.

Many doctors rely on the Pap smear to draw women in for annual visits, White said. Medical guidelines say Paps should be given every three years if the HPV test detects nothing wrong, which could lead some patients to skip the recommended yearly exam. It also takes more time out of an appointment to explain what HPV and the test are.

"It adds to the complications," White said. "It's very challenging to get people to change."

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Other professionals, however, aren't convinced the test is necessary in every instance for which it's approved.

On its Web site, the Abramson Cancer Center at the University of Pennsylvania points out that the HPV test "isn't perfect" because most women who test positive will never develop cervical cancer, and positive tests often lead to uncomfortable and expensive follow-ups.

And Johns Hopkins doctors only run the test after an abnormal Pap smear regardless of a woman's age.

"If a patient comes to us having read all the ads in the magazines, I usually tell them that if their Pap smear is normal and HPV Test is positive, we're not going to act on that anyway because there's been no changes to the cells," said Dr. Wen Shen, an assistant professor at the Johns Hopkins University Medical School.

Shen said the test has value in helping determine when cervical cell changes aren't harmful, like those associated with menopause.

Dr. Kimberly Dever, a Boston obstetrician and gynecologist, however, has been offering the HPV test as a primary screening tool in women 30 and older for more than two years. She said it took some time to incorporate, but it has been worth it: The test has found dangerous HPV strains in three of her patients who had normal Pap smear results.

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Two of the women had significant changes to cervical cells, which Dever was able to remove before they turned cancerous.

"Without the positive HPV test, with just normal Paps, I would have said come back next year," Dever said.

Dever is now part of a speakers bureau organized by the test's maker and is paid for her appearances. The company has lobbied hundreds of people and organizations in an effort to boost its business.

Since the test's initial approval in 2000, Digene has been able to get the major insurance companies to cover the cost of the test and its lab work (about $50), which is also required by law in six states, including Maryland. Similar legislation is under consideration in three other states.

Digene has 70 salespeople blanketing the country to educate doctors about the test, which has won the praise of professional medical societies and has no competitors. Yet its test, which had U.S. sales last year of $111.7 million, still has a ways to go before reaching its potential.

The company estimates that the test is appropriate for about 35 million U.S. women each year. During fiscal year 2006, which ended in June, about 6.65 million - or 19 percent of those meeting the test's criteria - took it.

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Grass roots education efforts are working to increase that percentage.

In 2001, when she was 25, Tamika Felder was diagnosed with advanced cervical cancer, though earlier Pap tests had come back normal. She lost her uterus because of it and endured chemotherapy and radiation.

Since then, the 31-year-old television producer, who lives in Upper Marlboro, has launched a nonprofit foundation to raise awareness about cervical cancer and its link to HPV (online at www.tamikaandfriends.org), in part through free, do-it-yourself HPV parties held across the country. They're sort of the sex-education version of Tupperware bashes, except safety is the only thing being sold.

And this month, she and musician activist Christine Baze launched the "Say Something" campaign and Web site (www.say-something.org) urging women to spread the word about cervical cancer and its causes. Both women have received grants from Digene to fund their efforts.

"We need to tell more people about [HPV] ... but not scare them," Felder said. "[We want women] to be proactive about their health."

tricia.bishop@baltsun.com


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