By Juhie Bhatia
Friday, April 21, 2006
Cervical cancer afflicts women of color and low-income women to a disproportionate degree. That's why health advocates say a vaccine pending FDA approval in June must be targeted at the populations who need it most.
(WOMENSENEWS)--A vaccine for cervical cancer awaiting approval by the U.S. Food and Drug Administration in June could be particularly important for low-income women and women of color, who are disproportionately afflicted by cervical cancer.
The vaccine could lead to important changes for women's health, said Debbie Saslow, director of breast and gynecologic cancers for the American Cancer Society. "The vaccine has the potential to eliminate or decrease significantly disparities in who gets cervical cancer," Saslow said.
If it is approved, the vaccine will be reviewed by an expert panel assembled by the Centers for Disease Control and Prevention in Atlanta, which sets guidelines for the appropriate use of a vaccine. The panel will determine whether it should be part of the standard roster of shots children receive before puberty.
While cervical cancer is far more prevalent in developing countries, the Atlanta-based American Cancer Society predicts almost 10,000 new cases of cervical cancer in the United States in 2006 and about 3,700 deaths, of which an estimated 750 will be African American women.
While many are excited about the possibilities the vaccine presents, others are concerned that its benefits may not reach those who need it most.
"It looks like there's lots of promise, but there needs to be lots of research and the vaccine needs to be targeted. Who will receive the benefit?" said Dr. Harold Freeman, senior advisor to the director of the National Cancer Institute and director of the Ralph Lauren Cancer Center in New York City. "We need public, scientific and medical policies that allow people at the highest risk for cervical cancer to receive the vaccine."
Congress provides about $200 million annually to fund breast cancer and cervical cancer screening programs for low-income and uninsured women.
However, only an estimated 20 percent of eligible women in the U.S. are currently receiving the benefits, said Freeman. "The disproportionate death rate from cervical cancer in minority women is overwhelmingly due to disproportionately higher levels of poverty and lack of health insurance in these women."
U.S. women with the highest cervical cancer death rates include African Americans in the South, Hispanics along the Texas-Mexico border, Vietnamese Americans, American Indians of the Northern Plains, Alaska Natives and whites in Appalachia, according to a 2005 report by the National Cancer Institute's Center to Reduce Cancer Health Disparities in Bethesda, Md.
The primary cause of cervical cancers are certain types of HPV, or human papillomavirus, a sexually transmitted virus that can also cause genital warts. Though Pap tests can detect HPV and catch cervical cancer early, half a million women globally still get the disease each year.
Last December drug maker Merck submitted a report on its HPV vaccine Gardasil to the FDA for approval. Merck spokesperson Deb Wambold expects the FDA to announce its decision in June. If it wins approval, the company says the vaccine could hit the market shortly thereafter.
The vaccine targets four types of HPV, two of which account for an estimated 70 percent of cervical cancers worldwide, according to studies.
So far the vaccine--which has completed clinical trials that included more than 25,000 people from 33 countries--appears to be safe and 100 percent effective against these two high-risk types. Before facing an FDA marketing decision, drugs must pass laboratory trials, which usually involve animals, and then clinical tests involving people.
The Gardasil vaccine can be administered in physician offices following FDA approval; after that, more specific guidelines and a recommendation about how widely the vaccine should be used will be set.
Merck is meeting with a range of government and nonprofit organizations to discuss how to accelerate access of the vaccine to the most vulnerable groups once approved, but no plans have been finalized yet.
"We are dedicated to working in partnership with others to ameliorate this tragic problem as expeditiously and effectively as possible," Wambold said.
GlaxoSmithKline, based in London, is also developing an HPV vaccine, but hasn't submitted it yet for approval in the United States; an application to the European Agency for the Evaluation of Medicinal Products is currently pending for use in the European Union. Its vaccine also targets the two highest-risk HPV types.
Some abstinence-only groups have expressed misgivings about widespread use of an HPV vaccine, though, arguing that its protection could encourage sexual activity.
Bridget Maher of the Family Research Council, a leading Christian lobby group based in Washington, D.C., told the British magazine New Scientist in April 2005 that, "Giving the HPV vaccine to young women could be potentially harmful, because they may see it as a license to engage in premarital sex."
However, Jessica Arons, director of the women's health project at the Center for American Progress in Washington, D.C., says political and moral opposition to the vaccine seems to be abating.
Merck's Wambold said the vaccine maker may have helped defuse some fears about the drug by meeting with groups who had concerns about it, including the Family Research Council, which has reviewed Merck's data.
The Family Research Council's October 2005 statement said it welcomes the HPV vaccine, but that practicing abstinence until marriage and fidelity within marriage are the best ways of preventing a range of sexually transmitted diseases.
Despite the objections of some religious groups, many health advocates support vaccinating early adolescents against HPV, before they become sexually active, since they say it will be the most effective way to prevent cervical cancer cases.
"In this country by the age of 15, 25 percent of children are sexually active," said the American Cancer Society's Saslow. "So if you give the vaccine after this age, you'll be missing 25 percent of them."
Health advocates say that even if the vaccine does reach the market, women must continue getting regular Pap tests, since the vaccine doesn't prevent all cervical cancers. Also, many questions will still remain about the vaccine's long-term effectiveness, whether it should be given to older women, if the vaccine will reach developing countries where it's needed most and its accessibility in the United States.
Juhie Bhatia is a writer based in New York City.
American Cancer Society--
Cervical Cancer Overview:
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