October 2007
HPV vaccine: Beyond the hype
A $40 MILLION AD CAMPAIGN Gardasil ads keep up a pro-vaccine drumbeat. That might get even louder next year when approval is expected for another HPV
vaccine, Cervarix.
"I want to be one less, one less," sing the giggling girls jumping rope in TV ads for Gardasil. The promise is that the vaccine
will make a woman "one less" victim by protecting her against the four dangerous strains of human papillomavirus (HPV) that
cause most cases of cervical cancer and genital warts.
Gardasil's manufacturer, Merck, has lobbied aggressively to make the new vaccine mandatory, and at least 20 states are considering requiring it for girls entering sixth grade.
But at $360 for a three-shot series (covered by most insurers), is a vaccine against HPV necessary? Consumer Reports has found that there are indeed compelling reasons for it--though they may not be ones you've heard.
Potential benefits
The number of Gardasil ads might give the impression that cervical cancer is a public-health emergency. But in the U.S., that's not the case. Today, regular widespread screening with Pap tests allows doctors to detect and treat abnormal cell changes in the cervix years before cancer develops.
So what's gained by getting the vaccine? For one thing, the presence of HPV triggers abnormal Pap smears in many women, and "that sets off a whole sequence of diagnostic procedures that take time, cost money, and cause pain," notes Vanessa Cullins, M.D., vice president for medical affairs at Planned Parenthood. The vaccine, she says, might spare them the angst and decrease the financial cost of follow-up.
For about 500,000 women a year, an abnormal Pap smear causes more than angst: They turn out to have precancerous abnormal cells, called high-grade cervical dysplasia, that are caused by HPV. Surgery is often required to remove the affected tissue. Research also suggests that the types of HPV commonly associated with dysplasia might be a factor in cancers of the anus, vulva, vagina, cervix, and penis.
Gardisil also protects against the two strains of HPV that cause about 90 percent of genital warts. Those aren't dangerous, but they are unpleasant and very contagious.
The vaccine is currently recommended for girls 11 or 12 years old. Teenagers and women who are sexually active can get Gardasil, but since they may have already contracted some strain of HPV, the shots might be less beneficial.
Safety concerns
The vaccine can cause minor side effects such as soreness or swelling at the injection site, fever, and dizziness.
Serious adverse effects, such as high blood pressure and gastroenteritis, occurred in less than 0.1 percent of the 11,778 vaccinated girls and women in seven preapproval studies.
Since then, the Food and Drug Administration and the Centers for Disease Control and Prevention have reported four deaths and 13 cases of the nervous-system disorder Guillain-Barre syndrome in girls and women who received Gardasil. They have determined that the deaths were unrelated to the vaccine and that the Guillain-Barre cases were most likely unrelated, though surveillance continues.
CR's take. Gardasil can help prevent cervical cancer, genital warts, and abnormal Pap smears, but even women who have received it should still get regular Pap tests because the vaccine protects against only 70 percent of cervical cancers. And until there are more long-term safety data, our consultants think the vaccine should not be made mandatory.
Gardasil's manufacturer, Merck, has lobbied aggressively to make the new vaccine mandatory, and at least 20 states are considering requiring it for girls entering sixth grade.
But at $360 for a three-shot series (covered by most insurers), is a vaccine against HPV necessary? Consumer Reports has found that there are indeed compelling reasons for it--though they may not be ones you've heard.
Potential benefits
The number of Gardasil ads might give the impression that cervical cancer is a public-health emergency. But in the U.S., that's not the case. Today, regular widespread screening with Pap tests allows doctors to detect and treat abnormal cell changes in the cervix years before cancer develops.
So what's gained by getting the vaccine? For one thing, the presence of HPV triggers abnormal Pap smears in many women, and "that sets off a whole sequence of diagnostic procedures that take time, cost money, and cause pain," notes Vanessa Cullins, M.D., vice president for medical affairs at Planned Parenthood. The vaccine, she says, might spare them the angst and decrease the financial cost of follow-up.
For about 500,000 women a year, an abnormal Pap smear causes more than angst: They turn out to have precancerous abnormal cells, called high-grade cervical dysplasia, that are caused by HPV. Surgery is often required to remove the affected tissue. Research also suggests that the types of HPV commonly associated with dysplasia might be a factor in cancers of the anus, vulva, vagina, cervix, and penis.
Gardisil also protects against the two strains of HPV that cause about 90 percent of genital warts. Those aren't dangerous, but they are unpleasant and very contagious.
The vaccine is currently recommended for girls 11 or 12 years old. Teenagers and women who are sexually active can get Gardasil, but since they may have already contracted some strain of HPV, the shots might be less beneficial.
Safety concerns
The vaccine can cause minor side effects such as soreness or swelling at the injection site, fever, and dizziness.
Serious adverse effects, such as high blood pressure and gastroenteritis, occurred in less than 0.1 percent of the 11,778 vaccinated girls and women in seven preapproval studies.
Since then, the Food and Drug Administration and the Centers for Disease Control and Prevention have reported four deaths and 13 cases of the nervous-system disorder Guillain-Barre syndrome in girls and women who received Gardasil. They have determined that the deaths were unrelated to the vaccine and that the Guillain-Barre cases were most likely unrelated, though surveillance continues.
CR's take. Gardasil can help prevent cervical cancer, genital warts, and abnormal Pap smears, but even women who have received it should still get regular Pap tests because the vaccine protects against only 70 percent of cervical cancers. And until there are more long-term safety data, our consultants think the vaccine should not be made mandatory.
