This has been portrayed as Round 15 in the fights over religion and science. It's the kind of thing that can make a parent crazy: you mean my child might be denied a potentially life-saving vaccine because it could sabotage an "abstinence only" message which, as the National Organization for Woman suggested, "presumably relies on a fear of cancer death to promote abstinence."
But for once in these polemical times, there may much more to agree on than to argue over. It a measure of the depth of suspicion on both sides that something almost universally hailed as a medical triumph still became a subject of controversy.
First, some history. The new vaccine, known as Gardasil, was approved earlier this month by the Food and Drug Administration, as the first ever designed to prevent cancer; it works by guarding against the human papillomavirus (HPV), which is thought to cause about three of every four cases of cervical cancer, the second most common cancer among women, and the third most deadly around the world. It kills close to 4000 women each year in the U.S. alone.
Public health experts say that vaccines generally work best when everyone gets them: the laws of "herd immunity" dictate that the more people are protected against a particular virus, the more likely it is to eventually disappear altogether. HPV is the most common sexually transmitted infection; the Centers for Disease Control estimates that 20 million Americans carry it. By vaccinating children before they are sexually active, there is a hope of dramatically reducing the prevalence of at least some strains for the next generation.
That means the next question is whether it belongs alongside measles and mumps and polio in the schedule of shots that children get before they're allowed to attend school. And this is where the fight breaks out. Back in the fall when the vaccine was submitted for FDA approval, some conservatives began asking whether physical protection could come at a moral cost: the technical term is "disinhibition, which the CDC defines as "an increase in unsafe behaviors in response to perceptions of safety caused by introduction of a preventive or therapeutic intervention." (Once upon a time the concern was raised about introducing anesthesia during childbirth, or using penicillin to treat syphilis, as spurring more sexual activity; more recently, the argument is made about needle exchange and condom distribution.)
The New Scientist in Britain quoted the Family Research Council's Bridget Maher warning that "giving the HPV vaccine to young women could be potentially harmful, because they may see it as a licence to engage in premarital sex." Others warned of promoting false confidence, since the vaccine does not protect against all strains of HPV or the many other sexually transmitted diseases. Reginald Finger, a former medical advisor to Focus on the Family who sits on the CDC advisory committee, told The Hill that "if people begin to market the vaccine or tout the vaccine that this makes adolescent sex safer, then that would undermine the abstinence-only message."
"Cervical Cancer Vaccine Gets Injected With a Social Issue," was the headline in the Washington Post. "Some Fear a Shot For Teens Could Encourage Sex."
Such concerns in turn inspired more than 100 lawmakers to write to the CDC to warn about playing politics with what should be purely scientific judgments. "Certain activists and organizations are mounting a campaign to prevent this vaccine from becoming widely available," the letter stated. "They cite the possibility that, by preventing a horrible disease, and more than 3,700 deaths a year, this vaccine could remove an obstacle to teenage sex.... In contrast to the strong scientific evidence supporting the effectiveness of the cervical cancer vaccine, there is no scientific evidence to support the fear that its use will promote sexual activity."
Women's groups also mobilized in support, worried that the fate of the vaccine could mirror that of Plan B, the emergency contraceptive that has been subject to political battles. "I lost my grandmother to cervical cancer, and have two daughters who might be spared that fate with this vaccine," wrote National Organization for Women President Kim Gandy. "Opposing an effective vaccine that would save hundreds of thousands of women's lives with the vacuous assertion that it would lead to promiscuity is inexcusable." At a time when government data shows 70% of girls having had intercourse by the time they're 18, the need for a vaccine seemed self-evident. "It was our belief that (conservatives) were trying to make their opposition clear to the FDA, which has been politically responsive during the Bush Administration to these conservative groups," says Gandy, "and that gave us tremendous concern that their influence would translate into non-approval of this vaccine."
It all seemed to have the makings of a classic political showdown, except that conservatives now say they were not actually "opposing an effective vaccine." "This is an awesome vaccine," Linda Klepacki, analyst for sexual health at Focus on the Family, told me when asked her about her group's position. "It could prevent millions of deaths around the world. We support this vaccine. We see it as an extremely important medical breakthrough. To read those headlines saying we're against this is really disconcerting." What they are against, she explained, is making vaccination mandatory rather than leaving it up to parents to decide.
Some groups hadn't even formulated a position until reporters started to call. "I haven't had another issue where our position has been so distorted and exaggerated," says Peter Sprigg, vice president for policy of the Family Research Council. The vaccine was never a high-priority issue, he insists; what concerns were raised were a little more nuanced. "The issue that has been discussed quite a bit, and where our position has been exaggerated, is whether it would have an impact on sexual behavior. It's not illogical to think that if you reduce the risk of one behavior people might be more likely to engage in it. That's not something we ever asserted was going to be case with this vaccine only that it was a question that at least needs to be raised."
So conservative groups met with representatives from Merck, the vaccine manufacturer, which among other things presented evidence at the CDC hearings that there was no data linking access to the vaccine with increases in sexual behavior. "We did what we ordinarily do when we are prepared to launch a vaccine," says Merck spokesperson Kelley Dougherty. "We met with physicians, consumer groups and in this case faith-based organizations, to talk about what the disease looks like, what the vaccine does; it was part of a broad communications strategy." Merck also launched an ad campaign, "Tell Someone," that aims to teach viewers about the prevalence of HPV and its link to cervical cancer.
Sprigg, who was in the meetings, came away impressed with Merck's handling of their questions. Its representatives, he said, "expressed sympathy with our concern that this not be distributed with an accompanying message that this makes it safe to have sex. They acknowledged the limits of the vaccine, that it does not target all strains of HPV, or any other sexually transmitted diseases." During public hearings on the vaccine held by the CDC's Advisory Committee on Immunization Practices (ACIP) in February, the Family Research Council representative applauded the vaccine, hoped that health care professionals would enforce the message that the only sure protection from sexually transmitted diseases is abstinence, but also called the vaccine a benefit because transmission can come during an assault or from an infected spouse.
The major point of contention surrounds whether to make the vaccine mandatory. The ACIP will weigh in during the last week of June; their recommendation will guide the federal government and insurance companies about whether to pay for the vaccine, which costs more than $300, and states about whether to require it for girls or boys attending school. Doctors follow their lead about what to consider the recommended standard of care, and so whether or not Gardasil becomes widely available largely hinges on the ACIP recommendation.
To conservatives, this comes down to a question of parental rights. Unlike diseases for which there are required immunizations, explains Klepacki, "this is a disease you don't catch by sneezing or coughing. It's linked to a behavior. You don't contract HPV by sitting in a classroom. So this is a different issue." Parents need to make an informed decision; her group's website includes the pros and cons of vaccination and has links to the CDC and the American Cancer Society. "You may want to vaccinate a child just in case," she says. "We see the extremely positive effects of this vaccine. But we want it to be out of the government's hands and in the parents' hands, because this is a sexually transmitted infection."
That position, responds Dr. Karen Loeb Lifford, a Boston Ob-Gyn who serves as medical director for Planned Parenthood in Massachusetts, "sounds incredibly reasonable. Who can disagree with parents making health decisions for their children? But take a closer look at that argument: it's denying the vaccine to many people who won't have access to it unless it's mandatory." Many parents might not know to ask for it, or be able to afford it. "If it's available in theory but it costs $375, its not available to everybody. If it's only effective before women have been exposed to HPV, we've missed our opportunity." Besides, she says, every state already has a law allowing parents to decline vaccination on religious grounds without their kids being banned from school. But "by making it mandatory, you make it accessible."
Sprigg denies that this is all a clever campaign to praise progress in public while derailing it behind closed doors. "We have no objection to it being part of the recommended standard of care," he says. Nor does his group object to Gardasil being covered by the federal Vaccines for Children program, which pays for immunizing uninsured and underinsured families. "So that should be sufficient to assure widespread distribution of the vaccine."
He even suggests that if handled in a certain way, vaccination could be a teaching opportunity. "If health care providers use this as an opportunity to talk to young people about sexual health, with the parents' permission, and explain the full range of risks posed by having non-monogamous relationships, it could have positive impact on adolescent behavior."
So how did his group and others come to be seen as trying to block a lifesaving treatment? One explanation is that they sensed a backlash from parents and moderated their position. "Originally some of the groups came out 100% against the vaccine," claims NOW's Gandy. "Some of those have backed off and are just saying they don't want it to be mandatory."
But another possibility is that both sides reflexively clenched their fists for a brawl, even when there wasn't much of a fundamental disagreement. Sprigg contends that there's "a theme running through liberal criticism of the Bush Administration and conservatives in general that they are anti-science. This a theme they'll point to on things as disparate as global warming, intelligent design, RU-486. I think people with that mindset just latched onto this, thinking it looked like a good example of that theme."
There may well be parents who are reluctant to give their nine-year-old in pigtails a vaccine against a sexually transmitted disease, that the very idea makes them incomfortable. But you have to wonder. It's not just that most nine-year-old girls don't know what a cervix is. Or that most doctors won't declare, as they administer the vaccine, "There! Now when you go out and have promiscuous, unprotected intercourse with strangers, at least there is one less sexually transmitted disease to worry about."
I think they're much more likely to say, "This will only hurt for a second."
Even if, as they got older, girls did understand somehow what the vaccine was protecting them against, surely the messages parents send to them every day and over the years about respect, responsibility, judgment and the boundaries of appropriate sexual behavior count for more than the implicit suggestion of a single vaccine. MSNBC did an online poll asking: If you have a daughter under age 15, would you have her get the cervical cancer vaccine? Of more than 8000 responses, 80% said yes, while 5.4% said, "No. She's too young to worry about sexually transmitted diseases."
But if conservatives are right that the vaccine sends a mixed message, then all the more reason to make it mandatory. That would allow concerned parents who favor abstinence to trust... but verify. And to explain that they're doing this for the larger good of the whole herd.