Minneapolis/St. Paul

A newly approved vaccine could prevent a widespread precancerous STD. But will anyone use it?

Let's Not Talk About Sex

Marilyn Joseph at the U of M medical school: "Why not be protected against something that's potentially life threatening?"

Image by David Fick

by Em Murphy
August 23, 2006

Each year, more than a quarter of a million women die from cervical cancer worldwide. But looming on the public-health horizon is a vaccine, stamped with Food and Drug Administration approval in June, which could prevent many of these deaths.Hindering what is a definitive advancement in women's health are semantic volleys about the effects of mandating the vaccination of presexual girls for a sexually transmitted disease.

The vaccine in contention protects against key strains of human papilloma virus (HPV). In the U.S. alone, 20 million people are infected with the wart-causing STD. While most of the 100 or so HPV varieties seem to have few long-term effects, causing common warts, plantar warts, flat warts, and the like, it is the cancer-causing strains that are most worrisome. According to the Centers for Disease Control and Prevention, about 80 percent of women older than 50 have been infected with HPV. The recently approved vaccine, which was designed by Merck and dubbed Gardasil, protects against HPV strains 16 and 18, which cause about 70 percent of cervical cancers, and against HPV strains 6 and 11, which cause about 90 percent of genital warts. In late June, a CDC panel recommended the routine inoculation of 11- or 12-year-old girls against HPV.

"We know that HPV infection often occurs within the first year or two of sexual debut, and therefore, a vaccine should ideally be administered before onset of sexual activity," said Lauri Markowitz of the CDC during the National Immunization Conference in March. "While there has been concern and speculation that there will be resistance to a vaccine for a sexually transmitted infection, surveys of a variety of provider types as well as parents are generally high acceptability." She went on to note that education about HPV would lead to a broader acceptance of the new vaccine.

But reconciling education about the disease and vaccine with well-funded, abundant, and fashionable abstinence-only sexual education programs might be problematic. There is, predictably, resistance from the religious right. And there is, as with any health care issue, concern about who will bear the costs. The reality of sexual education is that the just-say-no message doesn't necessarily get through. Seventy percent of young American women are having sex by age 18, according to the 2002 National Survey of Family Growth. But some are still concerned that the vaccine will be considered a green light to have sex.

"There's so much talk about that assumption," says Marilyn Joseph, medical director of Boynton Health Service and assistant professor in the Department of Obstetrics, Gynecology, and Women's Health at the University of Minnesota Medical School. "At some point they are going to have sex, and why not be protected against something that's potentially life threatening?"

The long-term effects of HPV vaccines will ultimately be felt in nations like Haiti, in which, according to the World Health Organization, cervical cancer accounts for almost half of cancer-related deaths. But until these vaccines become both affordable and available to the global public, cervical cancer will continue to devastate. The FDA approval of Gardasil here is just a first step.

Worldwide, cervical cancer is the second most common cancer in women. Unlike many other cancers, cervical cancer is considered preventable through screening and treatment of precancerous spots. Increased screening with regular Pap smears has caused rates stateside to more or less bottom out. While this is a major public health accomplishment, about 13 percent of women nationwide are getting Pap smears less frequently than every three years, according to a 2002 report by the Behavioral Risk Factor Surveillance System.

Even in Minnesota, more than 10 percent of women older than 18 had not had a Pap smear in the past three years as of 2002. And Minnesota is one of the nation's most compliant states. In neighboring states, the number of women skipping the test is higher—Wisconsin and Iowa's rate is 12.2 percent each, with North Dakota tallying 13.4 percent and South Dakota 13.8 percent.

The potential good for a vaccine comes in here. Each year, public health officials estimate, there are 6.2 million new HPV infections in the U.S. This includes about 15 percent of 15- to 49-year-olds. It is worth noting, though, that more than 90 percent of HPV infections clear the system within two years.

"HPV can go away...even though there's no cure for it, it doesn't mean that the person is saddled with it for the rest of their lives," Joseph says. Still, there's cause for concern. HPV can result in genital warts and cervical cancer, and, though rarely, can cause penile cancers in men, vulvular cancers in women, and anal and head and neck cancers in both genders. In other words, HPV cannot simply be relegated to the realm of sexually transmitted disease.

For all the medical reasons to vaccinate against HPV, there is a catch. Gardasil, which is administered by a series of three injections, is expected to cost around $400. For a woman who can't afford a regular Pap smear, which is the standard cervical cancer-screening test and costs about $50 if paid out of pocket, $400 might be an insurmountable charge.

Aside from cost, there are other barriers for the makers and proponents of Gardasil. It is true that "conservative groups have not actively opposed this vaccine," as Markowitz said at the March CDC conference. But there is a matter of contention over whether to make the vaccine mandatory.

On the one hand, mandating the vaccine would maintain its place in the Vaccines for Children program, which provides free vaccines for Medicaid-eligible American Indian and Alaskan Native children. This would ensure the vaccine's availability to many of the nation's poorest girls, who could reap the greatest health benefits from it. Vaccines for the Vaccines for Children program are purchased by the CDC in bulk, but even bulk priced, the cost of immunizing all eligible girls would be huge; some estimate about $2 billion.

On the other hand, conservative groups are balking at the suggestion that the vaccine be required. "Focus on the Family supports widespread availability of HPV vaccines but opposes mandatory HPV vaccinations for entry to public school," reads the Christian nonprofit's HPV vaccine position statement. "The decision of whether to vaccinate a minor against this or other sexually transmitted infections should remain with the child's parent or guardian."

Which is all well and good, but such positions would seem to fly in the face of common sense. Nearly every state allows parents to opt out of vaccinating their children. And there is less concern about the hepatitis B vaccine that is required in Minnesota for kindergarteners, even though hepatitis B can also be spread by sexual contact.

Just one partner who has been infected with one of those cancer-causing strains of HPV or many other sexually transmitted diseases can forever alter a woman's life. While cervical cancer is less of an issue in developed nations, it is the nature of drug design for the wealthy to have first dibs while developing nations will eventually feel the trickle-down effect. As with so many matters like this, people like Boynton's Joseph see the HPV vaccine as a matter of public health—not a moral quandary—for everyone.

"I'm one who buys life insurance and travel insurance, so to me this [vaccine] is a kind of insurance," says Joseph. "I never had a girl, but if my boys had been able to get it, I would have given it to them."

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