In Our Control (41 page)

One of the major issues to emerge from the conversation about compulsory Gardasil vaccination concerns the power of parents to decide what
is right, medically and socially, for their children. In fact, when public health is in the balance, US states are well within their rights to require vaccination. Alexandra M. Stewart, a lawyer with George Washington University Medical Center, notes that early in the twentieth century the Supreme Court granted the states “police power” with which to enforce vaccinations thought to “protect the public health and the public safety.”
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At issue, of course, is the difference between HPV and other infectious diseases that can be prevented with shots. As I noted before, the key difference is how the infections are spread. While measles, for example, can be spread through casual contact, HPV transmission requires intimate contact. This makes the public health threat, from a traditional perspective, much less compelling.

Parental objections to Gardasil are often framed by other cultural conversations. One group that particularly opposes the idea of forced vaccinations is the growing number of parents who object more generally to state enforcement of shots. This movement has gained momentum in past years because of unproven beliefs that vaccines cause autism (a claim that all recent science suggests is unfounded) and fear that chemicals and metals used to increase vaccine uptake, like aluminum hydroxide, may lead to degenerative diseases like Alzheimer’s or Parkinson’s.
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One study found that parental willingness for children to receive Gardasil in any context, not simply in mandatory programs, was considerably informed by their more general attitude toward childhood vaccination programs.
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Another major group predictably objects to HPV vaccination out of the worry that promoting it prematurely forces a conversation about sexuality with young children. As one expert editorialized in the
New England Journal of Medicine
, “Opposition seems to be based on the concern that to recognize the reality of teenage sexual activity is implicitly to endorse it.”
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An inability to communicate complicated ideas about this part of adult life to children is also a source of anxiety. One British mother writes, “Of course we need to tell our kids about sexually transmitted disease, but I’m not sure I want them, at a tender and impressionable age, to equate sex with disease.”
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She adds more pointedly about school immunization programs, “We’re constantly told we should be responsible parents, but I’m coming to think that this is a euphemism for compliant.”
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If the right of parents to determine whether their daughters will be vaccinated
is important, it is equally valid to ask what an individual girl’s rights to self-determination should be in the context of HPV prevention. Catherine DeAngelis addresses this problem, noting, “Consider the information a clinician can honestly provide to a twelve-year-old girl to obtain her assent: ‘the three injections will probably protect you from an infection that you can only get from sexual contact, but research has not shown how long the protection will last or whether it might have bad effects on your health.’ ”
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The
Lancet
, one of Britain’s top medical journals, comes to a similar conclusion: “It is worrying that most girls being offered vaccination against HPV might have no concept of what the virus does, and certainly therefore no understanding of the benefits of immunity.”
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Concerns about children and sexuality pose serious threats to access for young women who might decide later in their teen years to be vaccinated before becoming sexually active. As one British mother explains, “If the decision is left up to the girl, is she really going to go to her parents when she is fifteen and say: ‘I think it’s time to have this vaccination’?”
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If going to parents is an admission of intent, it is difficult to imagine most teen girls paying a minimum of $360 (most likely closer to $500 or $600 once doctors fees are factored in) out of pocket to avoid parental detection. So most girls will either get the vaccine when they are too young to be informed consumers, or they will wait until they are financially independent—and by then, statistically speaking, they will already be sexually active.

If there are serious ethical problems with giving the shot to young girls, there are practical concerns as well, particularly the lack of extensive clinical data on that age group. While thousands of women received Gardasil shots as part of approval studies, very few women under fifteen—less than two thousand—received the vaccine in advance of approval. So while it was found safe in many women, the age group most likely to receive the shot was left out. Efficacy studies, which show near 100 percent effectiveness for women sixteen to twenty-six, are lacking in younger girls.
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Canadian Women’s Health Network representative Madeline Boscoe spoke to the age gap in trial evidence saying, “It’s scary to think of vaccinating a whole generation of nine-year-old girls in this country based on a hundred [people] … The duty around evidence here should be so much higher.”
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For feminists and women’s health activists, the Gardasil experience raises a different set of ethical and historical problems. While Gardasil is most likely as efficacious in men as it is in women, only female populations were tested for approval of the vaccine. This happened for complicated reasons, among them a desire on the part of the drugmaker to establish the product with as few ties to the term “sexually transmitted infection” as possible. If Gardasil could be sold as an anticancer measure, it stood to gain faster acceptance than as a prophylactic for safer sex.

This singling out of women coupled with the speed and heavy-handedness with which most states attempted to enforce programs raised fears that Gardasil was about to become the next chapter in America’s unfortunate history of forcing the burden of STI prevention on female bodies. A particularly dramatic example of this occurred during World War I, even as American attitudes toward contraception were changing and easing. Carole R. McCann notes, “During the war, an adolescent girl could be arrested for public flirting or consorting with military personnel.”
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Once arrested, women could be medically examined to test for STIs, and if the results were positive, they were often incarcerated without trial for indefinite periods of time and subjected to treatment.

Because women in America—particularly poor, immigrant, or nonwhite women—live with this history, it is little wonder that they are suspicious when government bodies begin mandating medical procedures and threatening the removal of basic rights—such as school admittance—for noncompliance. As Abby Lippman explains, “All the focus on the vaccine makes it seem as if this is only a women’s health care issue. Why is it almost always girls’ and women’s sex lives that are put under scrutiny? Why are they alone made to bear the weight of preventing HPV transmission?”
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Despite many very good reasons to reject mandatory programs, it seems likely that such plans failed more because of dubious parental anxiety about sexuality and peripheral vaccine-related illness than out of concern for the individual rights of women. Somehow it has become very complicated to say that HPV vaccination could be a wonderful thing and that women should be able to choose it for themselves. Along the way these two ideas have become mutually exclusive.

But the silver lining in any case is that the vaccination has given parents new confidence as savvy health consumers who can talk back to forces in the medical and political communities who are in the service of drugmakers instead of families. Patients reorganizing such power relationships can be seen as a step in the right direction as long as it can be coupled with good science and informed (rather than frightened) health consumership.

For immigrant girls and young women, there is still no choice when it comes to HPV vaccination. Because of a 1996 law requiring the Citizen and Immigration Services to mandate all suggested shots, all women immigrating to the United States who fall into the CDC’s recommended age group must get the vaccine.
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Most young women must have the first dose before they come to the United States, and they probably pay the huge price out of pocket. Tuyet G. Duong, a lawyer with the Asian American Justice Center in Washington, DC, explains that Gardasil, in part because of its high cost, “is just an additional barrier to coming to America … It just adds another layer to what has become a toxic environment for immigrants.”
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Because of steep costs, many girls may not be able to get the second and third shots to make the entire process efficacious. Immigrant advocates point out that it is premature to force Gardasil on such a large population without more conclusive data about side effects and long-term usefulness. Angelica Salas, the director of the Coalition for Humane Immigrant Rights in Los Angeles, says, “We don’t want to convey that we don’t want individuals to make healthy choices or seek out preventative healthcare … We just don’t see why it should be linked to immigration.”
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At the time this chapter was being edited, the HPV requirement was being reviewed but had not yet been repealed.

For low-income women in America there are more options. If parents opt to have young daughters vaccinated, they can likely get the majority, if not the entirety, of the shot covered. The Vaccines for Children Program provides the vaccine for children on Medicaid and those who are uninsured or underinsured. While adults must pay entirely out of pocket for any vaccine, “for children, almost 60 percent of vaccine doses are purchased through federal contracts.”
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The government is paying a hefty sum for the shot; despite intense negotiations, federal immunization program administrators received only a 20 percent discount, bringing
Gardasil’s price tag to $288 instead of the usual $360. Merck also offers assistance to low-income individuals through the Merck Patient Assistance Program.

According to the
New York Times
, “Health economists estimate that depending on how they are used, the two cervical cancer vaccines will cost society $30,000 to $70,000 or higher, for each year of life they save in developed countries … The number will be far higher if a booster is needed.”
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This astronomical amount of money will direct resources away from other health measures, particularly for the uninsured and the underinsured.

How many girls have received the vaccine? Around 25 percent in the United States have been given at least one of the three doses, according to Lance Rodewald, director of immunization services at the Centers for Disease Control and Prevention.
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Of these, only one fourth have received all three shots. There are significant ethnic, class, and racial differences in the data. For example, only 1 percent of Latina teens have gotten the shot despite the fact that they are at greater risk for contracting dangerous strains of HPV than their white peers.
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African American teens are also at an increased risk of both HPV and cervical cancer. But despite slower than expected uptake, Merck is making a tremendous amount of money: in 2008, Gardasil had “projected sales of $1.4 billion to $1.6 billion outside Europe” in addition to, of course, “more sales from Europe.”
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Gardasil for Boys

It was only a matter of time before pharmaceutical companies started imagining the possibilities their vaccine held for men. In November 2008, a Merck-funded study of four thousand boys aged sixteen to twenty-six found that Gardasil had the same antiwart efficacy for men—as much as 90 percent protection—as it offered female populations.
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In addition, the drugmaker stressed that certain rare but terrible cancers in men were also tied to HPV.

Allan Cassels, a tireless crusader against pharmaceutical company machinations, worries that a desire to market Gardasil to young men will lead to an overstatement of the risks of rare illnesses, such anal and penile
cancers, which have been tied to HPV but don’t pose the threat seen with cervical cancer: “It strikes me this is the vaccine manufacturer seeking basically more markets … In order to sell the vaccine, you’ve got to sell the size of the problem.”
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A 2007
New England Journal of Medicine
article authored by Stina Syrjänen (who disclosed receiving consulting fees from Merck) tied certain head and neck cancers to HPV and argued, “It is worth considering the possibility that some oral, oropharyngeal, and laryngeal cancers might be prevented by HPV vaccination.”
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In early 2009, Merck filed paperwork with the FDA to extend their recommendation to boys ages nine to twenty-six, and in October of that year, the FDA approved the use of Gardasil in men. The approval came only hours after the FDA threw Merck’s rival, GSK, a bone by finally green-lighting Cervarix after years of delay.

Women’s health groups, family health advocates, and others in the public health world are conflicted about the news. Diana Zuckerman, head of the Washington, DC–based National Research Center for Women and Families, testified against FDA approval. Her concerns, most of which apply to girls as well, include the short length of trials, the uncertainty of the shot’s duration of efficacy, and—specifically in the case of boys—the very limited health benefits. “When the vaccine was first approved for girls, we supported it,” Zuckerman tells me. “But now that we have examined the data more carefully, we question its value, for women or men.”
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