Sex vs. death

Will the religious right stymie the first-ever cancer vaccine?

By Tali Woodward

tali@sfbg.com

One might think a medical breakthrough that could prevent most cases of cervical cancer would be met uniformly with joy.

Think again.

Two separate but similar vaccines for human pampillomavirus, a sexually transmitted infection that is the primary cause of cervical cancer, have recently been developed. In clinical tests they have proven to be shockingly effective. Medical researchers say the vaccines, if administered routinely, could virtually eradicate the second most fatal type of cancer in women.

The problem is this: It makes sense to administer the vaccine to women who haven't yet been exposed to HPV – in other words, women who haven't had sex. The best way to do that is to inoculate preteen girls. But some conservatives see the vaccine as an invitation to be promiscuous – and are gearing up to limit its reach.

Even though many people have never heard of HPV, it's the most common sexually transmitted infection around, infecting up to 80 percent of Americans at some point before they turn 50.

Public health officials have found stemming the spread of HPV particularly challenging because it can be transmitted simply through the contact of skin in affected areas, with condoms offering only limited protection.

Most women have immune systems strong enough to kill HPV. But in some, HPV causes genital warts. And in others, the virus causes potentially cancerous cells to develop in the cervix. (It's possible, though significantly less common, for HPV to cause cancer in men.)

Cervical cancer – which researchers believe is almost always tied to HPV – kills more than a quarter million women each year. Women who live in developed countries where regular Pap smears are the norm are fairly well-protected because the test can detect precancerous cells that doctors can then remove. Still, in the United States about 3,900 mostly lower-income women die of the disease each year.

But in recent years, two pharmaceutical companies, Merck and GlaxoSmithKline, have announced development of a vaccine – administered in three doses over six months – that protects against HPV, and therefore against cervical cancer. In clinical tests both have proven extraordinarily effective: They blocked contraction of the two most dangerous types of HPV in every woman who had been inoculated.

Dr. Joel Palefsky, a UC San Francisco professor who is an expert on HPV, said he thinks the development of these vaccines is "the most important thing since sliced bread in the HPV business" and something that ranks high on any list of recent medical advances.

But not everyone is greeting the vaccine with such enthusiasm.

Conservative groups, including the Family Research Council, Concerned Women for America, and the National Abstinence Clearinghouse, have already suggested that vaccinating young girls would send them a message that premarital sex is acceptable. Christian-oriented Web sites have also been following objections to the vaccines more closely than mainstream news organizations.

Palefsky characterized concerns that the HPV vaccines will encourage promiscuity as "nonsense."

"There's no evidence to suggest that the risk of HPV is a factor in someone's decision whether or not to have sex," he said. (He also pointed out the vaccine is somewhat of a boon to HPV education efforts since news coverage of its development is probably acquainting many people with the virus for the very first time.)

Meanwhile, the Merck vaccine, which is called Gardasil, is wending its way through the Food and Drug Administration's approval process. Everyone believes that unless there's a repeat of the political maneuvering that surrounded the agency's rejection of the application to sell emergency contraception over the counter, Gardasil will be approved in the next six months and available to US women sometime in 2006.

But the real political challenges to widespread acceptance of the HPV vaccines may not end there. Groups and politicians who have questioned the overall wisdom of the vaccine are focusing on whether or not it is included among the government's official vaccine recommendations.

Control over those recommendations rests with a panel assembled by the Centers for Disease Control and Prevention. Vaccines that get the panel's stamp of approval are frequently added to state lists of inoculations that are required before a child begins a certain grade in school, as the tetanus and polio shots usually are. They also commonly become eligible for insurance reimbursement – a huge step toward becoming part of mainstream care.

For some time the CDC has recommended that children aged 11 to 15 receive the vaccine for Hepatitis B, an infection that is usually transmitted through sex. And the Hep B vaccine regimen is very similar: three shots over six months. Ideally the HPV vaccine could be given at the same time.

But if conservatives interfere with the CDC process, or prevent government funding of the HPV shots, access to this breakthrough vaccine could be seriously curtailed.

Things could also get interesting when Cervarix, the vaccine manufactured by GlaxoSmithKline that is expected to make its debut in Europe, goes through the process for for US approval. Cervarix actually elicited an immune response that was twice as strong when given to girls aged 10 to 14. In other words, earlier vaccination could eliminate the need for booster shots. It's unclear how the right will respond to that medical evidence.

Alan Kaye, who became the executive director of the National Cervical Cancer Coalition after the disease killed his wife, told us he hopes critics of the vaccine back down. "I can tell you, with a ripped heart, that anyone who's ever battled cancer themselves or with family or friends would be for it," he said. "I mean, how can you not be for a cancer vaccine?"

www.nccc-online.org

www.maketheconnection.org

www.niaid.nih.gov/factsheets/stdhpv.htm