Joan Wilder: Journalist, Writer, Editor

Outcry Over HPV Vaccine Indicates Need for More Education

Cover of Nursing Spectrum, featuring HPV article.

The HPV vaccine is a breakthrough in the fight against cervical cancer

The new vaccine for human papillomavirus (HPV) is challenging the way nurses — and the public — think about vaccines, governmental mandates, and HPV’s classification as a sexually transmitted disease.

The U.S. Food and Drug Administration approved Gardasil, manufactured by Merck & Co., to prevent HPV. The vaccine protects against four types of HPV, two of which are responsible for the majority of cervical cancer deaths.

The CDC estimates that an average of 233,000 women in the world die of cervical cancer each year. In 2004, the U.S. saw 10,500 cervical cancers diagnosed and 3,900 cervical cancer-related deaths.

But these figures don’t tell the whole story. Not only can HPV cause cervical cancer, it is also associated with millions of cases of genital warts and cervical dysplasia — a precancerous condition that has high physical, emotional, and monetary costs.

In addition, HPV causes various percentages of the total number of cases of less common cancers, including penile (90%), anal, vulvar, and vaginal, says Dartmouth Medical School Professor Diane Harper, MD, MPH, MS, one of the chief investigators on the multinational trials for Gardasil and Cervarix, a similar vaccine manufactured by GlaxoSmithKline that is expected to be licensed within a year.

“Decreasing the spread of a virus known to cause cancers is an exciting breakthrough,” says Debra Otani, RN, OCN, oncology navigator at Montgomery General Hospital, Olney, Md. “When these diseases and the spread of these diseases are prevented or even reduced it should improve quality of life for many individuals.”

“We’re all for the vaccine, we advocate for it,” says Barbara Harvey, RN, staff nurse at the Harry and Jeanette Weinberg Center for Women’s Health and Medicine at Mercy Medical Center, Baltimore, Md. “It can prevent a majority of cervical cancers when used correctly. If there was a vaccine to prevent breast cancer, we’d be lined up for it.”

Education campaign needed

Clinicians need to have a thorough understanding of the vaccine’s risks and benefits in order to counsel patients and their families about the vaccine. Mercy’s Center for Women’s Health has given between 125 and 150 doses of the vaccine since November. When a patient comes in for Gardasil, she has a consultation with the center’s physician and receives an educational handout that explains about HPV and the vaccine, Harvey says.

“As a cancer navigator, I frequently am asked questions about information people have seen advertised, read online, or heard from a neighbor,” Otani says. “I have a great deal of concern that women and men need to know more about the vaccine and especially the need to have regular medical follow-up. You don’t have to look at too many websites and on line chat groups to see that a lot of misinformation is out there.”

Some of the questions raised by patients were addressed at a Women’s Health Expo held recently at Montgomery General. The event included information and lectures about the HPV vaccine, cervical changes, and cancer awareness.

A stealthy virus

Many carriers don’t know they have HPV, since the body often can fight it off without symptoms. People can contract HPV, recuperate, and get it again. It is the most common sexually transmitted virus, and it is startlingly widespread. According to the CDC, 80% of women over age 50 will have carried some type of HPV at some point in their lives.

But women are not alone in harboring the virus; males and females of all ages are at risk. “Ten percent of the [total] population at any given time, no matter what age they are — 3, 11, or 72 — will have high-risk, cancer-causing HPV types,” Harper says.

“When you start to understand the magnitude of the problem, you realize how incredibly powerful the vaccine is,” Harper says. “This is a really, really common virus that most people will have at some point in their lives.”

Health leaders support vaccine …

After the FDA granted its approval, the CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously recommended that the vaccine be routinely given to girls and women 11 to 26 years old and to 9- and 10-year-olds whose doctors recommend it. Many national and state public health organizations, including the American Cancer Society, the American Academy of Pediatrics, and The American College of Obstetricians and Gynecologists also quickly recommended its use.

In addition, ACIP recommended that Gardasil be added to the list of vaccines in the Vaccines for Children (VFC) program — a federal initiative that provides free vaccines to children in need. The vaccine’s approval for use in the VFC program does not make it mandatory for children entering school. Such decisions are made by each state. In recent months, more than 20 states introduced legislation related to the vaccine (see sidebar, “Pending legislation,” left), creating a flurry of media attention.

… But public is wary

Intense lobbying efforts by Gardasil’s manufacturer Merck & Co. prompted many states to consider mandating the vaccine. While it is common practice for large corporations to lobby state and federal lawmakers in support of their products, Merck abruptly withdrew from its lobbying campaign Feb. 20. The company’s medical director explained at the time that public outcry claiming the vaccine promoted sexual promiscuity was a distraction from the company’s goal to prevent cervical cancer.

HPV’s classification as a sexually transmitted disease belies the fact that it also is transmitted by various skin-to-skin contacts. For instance, HPV living under the tips of the fingernails can easily get into the nose (especially the noses of children, for example) and remain there for years.

“This is a virus that causes cancer in every part of our bodies that are moist, wet skin,” Harper says. “Moist epithelium is at risk.”

Administering the vaccine

Gardasil vaccination entails a three-part series of intramuscular injections over a six-month span. Together, the three injections prevent nearly 100% of the high-risk, cancer-causing infections caused by HPV types 16 and 18 and 90% of cervical warts, which are caused by HPV types 6 and 11. The vaccine does not contain any live virus, mercury, preservatives, eggs, or DNA. The only adverse reactions reported by study participants have been mild or moderate pain and tenderness at the site of the injection.

The vaccine is not a cure-all, however. It protects against only four of the nearly 100 types of HPV that exist. Therefore, even vaccinated women must continue to have Pap screenings.

“This is only one of many sexually transmitted diseases that have serious long-term consequences,” Otani says. “And although this vaccine is the first of its kind to build immunity against two strains of HPV, which lead to 70% of cervical cancer cases in the United States, that still leaves 30% that are not that require vigilance in recommended screenings.”

Who should get it

Amy Middleman, MD, MPH, MSEd, an associate professor of pediatrics at Texas Children’s Hospital, consulted with the CDC advisory committee as it made its recommendations about the vaccine. To respond to parents who say their daughters don’t need the vaccine because they are not sexually active, Middleman suggests talking about its role as a preventive agent.

“It is very important to give it prior to any sexual activity,” she says. “Because we know that she will most likely become sexually active at some later time, it’s very important to protect her … well before that time.”

Harper suggests linking vaccination with the onset of puberty — rather than the onset of sexual activity. “It’s a much nicer way to do it,” she says. “When a girl needs to buy her first bra, that’s a good time to get the vaccine.”

Besides the recommendation for younger girls, ACIP advises that females aged 13 to 26 get a “catch-up” vaccine.

“I think it’s something that every woman should look at, even if you’re 50,” says Jane Dimmitt Champion, FNP, PhD, of the Uvalde Family Practice, a rural community health center and an associate professor in the department of family nursing at the University of Texas Health Science Center at San Antonio.

Reaching the underserved

Perhaps the biggest challenge Gardasil and Cervarix present will involve distribution to underserved populations. Among other barriers, the cost of the three-vaccine series is about $360.
“It is a known fact that the underserved population frequently enters into the healthcare system at a later stage of disease, with less chance of cure and poorer outcomes from treatment,” Otani says. “All of us, and especially navigators and other healthcare providers, need to take every possible opportunity to improve these underserved populations’ accessibility to affordable HPV vacccinations.”

Joan Wilder is a freelance writer. To comment on this story, e-mail pmeredith@gannetthg.com.

Pending legislation

Legislation for mandates is still pending in at least 18 states and the District of Columbia, most with enforcement dates of 2008 or 2009. Some proposed laws include more lenient exemption rules for the HPV vaccine than for other mandated vaccines.
Virginia Gov. Timothy Kaine said March 1 that he would sign legislation requiring all sixth-grade girls to be vaccinated, beginning in the 2009-2010 school year.

In late January, Maryland state Sen. Delores Kelley (D-Baltimore County), withdrew legislation she had introduced to mandate the vaccine. A new bill was introduced Feb. 9 to establish a task force charged with recommending plans for implementing the HPV vaccine, including educational efforts and a possible mandate.

More information is available at the CDC’s HPV Vaccine Questions and Answers’ website: www.cdc.gov/std/hpv/STDFact-HPV-vaccine.htm

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