HPV Vaccine Flags Need for More Pap Tests

A little more than a year ago, the nation's first vaccine against some human papillomavirus (HPV) infections was released.

This medical progress against cervical cancer got swept up by fear-based marketing that helped to generate premature calls for government mandates.

"You could become one less life affected by cervical cancer" is the mantra in most of Merck's ads for its vaccine, called Gardasil. The ubiquitous marketing campaign may leave viewers thinking that cervical cancer is more prevalent than it really is.

Merck also lobbied behind the scenes to make its vaccine mandatory for school-age girls, quietly funding groups such as Women in Government that promoted mandatory vaccination bills in state legislatures. Such a mandate, if passed quickly, would have increased the firm's sales before a competitor's product -- soon to hit the market -- was available.

When Merck's funding was exposed, the tactic backfired, fanning suspicions that profit motives were overwhelming public health concerns.

Opposition came from other camps too. Some parents pointed to the new vaccine's side effects (which are usually minor and transient) and questioned whether it should be required. Social conservatives raised concern that the vaccine could lead to increased sexual activity among America's youth.

HPV vaccination has been approved for females ages 9 through 26 and appears to be most beneficial for girls with no prior sexual activity. Studies show that vaccination after virus exposure is only minimally effective. The vaccine is not recommended for pregnant women, anyone with moderate to severe acute illnesses or anyone with sensitivity to vaccine components.

All of this has left a number of questions simmering.

Would a Mandate Reduce Cervical Cancer?

The U.S. Centers for Disease Control and Prevention predict a 22 percent to 60 percent reduction in cervical cancer attributable to this vaccine. However, for these reductions to be realized, a high proportion of young women will have to be vaccinated. Even then, reductions in invasive cervical cancer won't be measurable for several decades.

Many believe mandates are premature. Gardasil appears safe and effective up to five years, the length of time studies have covered so far, and if its effects are as strong over the long term as early results suggest, then requiring and funding vaccination for school-age girls (with exceptions for families who opt out) may become the best way to ensure access and protection for all girls, regardless of class or race.

About 10,000 cases of cervical cancer will be diagnosed this year in the United States, and about 3,700 of these women will die from the disease.

Most who die of cervical cancer never had regular Pap tests. These screening tests can detect pre-cancerous tissue, which can be removed to prevent the development of cervical cancer.

In the United States, there are 6.6 cases of cervical cancer for every 100,000 white women and 10.5 cases for every 100,000 African American women. The racial disparity is due at least in part to women of color having less access to screening.

Globally, in regions where screening is much less common, the numbers are much worse. In areas of Africa, Central and South America, and Micronesia, there are more than 50 cases of cervical cancer per 100,000 women.

We don't know yet if requiring vaccination could reduce cervical cancer deaths and reduce racial and ethnic disparities in terms of HPV prevalence, cervical cancer incidence and cancer mortality. It is possible that women who do not get regular Pap screening and follow-up now will also be those least likely to be vaccinated, even with legislative mandates in place.

If there's one thing the discussions make clear, it's that we need to try harder on Pap tests. Cervical cancer used to be a leading cause of cancer deaths among U.S. women. But since the introduction of the Pap smear in the 1940s, those deaths have dropped about 75 percent, even as the population has grown.