In Our Control (40 page)

Another unanswered question with potentially huge ramifications is the issue of how long immunity lasts. Some vaccines provide lifelong protection, while others require periodic updates, or “boosters,” to maintain effectiveness. As Abby Lippman and colleagues asked in a controversial
CMAJ
article, “Will boosters be needed to maintain this limited coverage, and if so, when?”
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Most estimates assume that coverage will last at least five years, although some data suggests it may be closer to three or four. If boosters are needed, the consequences for large-scale vaccination will be significant. First, it may upset the optimistic cost effectiveness projections, making giving the shots to all teens too expensive.
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Second, and
perhaps worse from a health perspective, it may render young people temporarily immune during the time they are most able to fight the infection only to make them vulnerable at older ages when they are less able to heal and more likely to progress to cancer.

As one writer notes, “Cancer data show that the average cervical cancer patient is forty-seven and most likely contracted HPV, which incubates for up to fifteen years before becoming cancer, in her thirties.”
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Since studies show that HPV rates are highest in the midtwenties, this data suggests that women become less able to fight off infection as the years pass. They are more likely to face HPV in their twenties, but more likely to see it morph into something truly dangerous later in life.

Merck, who insists that its shot will last, has possibly been playing fast and loose with the science on this subject. Diana Zuckerman of the National Research Center for Women and Families explains that while no product called a booster is currently available, Merck did give an additional dose of the shot to girls before measuring their antibodies at the five year mark.
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If this is true, it means that the drugmaker basically gave women an additional dose and then claimed that the original three were still working several years on. Zuckerman notes that the shot has only been shown to last for two years and explains that Merck “isn’t talking publicly about a need for a booster shot … perhaps because the vaccine is expensive and most people wouldn’t be willing to pay $400+ for a vaccine that lasts less than 5 years.”
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Even if vaccinations last indefinitely, which seems unlikely, receiving them may make young women less likely to get Pap smears and utilize screening methods essential to thorough cancer detection and prevention. As long as annual exams remain tied to oral contraceptive access, however, it seems likely that many women in developed nations will continue to have them, at least in their twenties and thirties. Just as worrying is the possibility that vaccination will lead to a drop in condom use, particularly in high school and college populations. While earlier studies have suggested little to no benefit from condoms in the prevention of HPV,
⁶⁶
more recent work has in fact found a great benefit from using a good, old-fashioned rubber. An article published in the
New England Journal of Medicine
found that “among newly sexually active women, consistent condom use by their partners appears to reduce the risk of cervical
and vulvovaginal HPV infection.”
⁶⁷
How much protection did condoms users get? One study found that women whose partners used condoms reduced their HPV risk by 70 percent, and even those whose partners used condoms only half the time had a 50 percent reduction when compared with noncondom users. Other lifestyle interventions that cut HPV risk include eating better and smoking less.

Another concern, according to the
New England Journal of Medicine
, is that suppressing certain dangerous strains—namely HPV 16 and 18—might allow other varieties of the infection to emerge and change and be more dangerous than anticipated,
⁶⁸
altering the natural history of the virus.
⁶⁹
If HPV types not prevented by the shot start accounting for a larger percentage of cancers, it could render the vaccine less relevant from a public health perspective.

While slightly older women are more likely to get cervical cancer, young women still suffer from it. One thing that makes cervical cancer headline grabbing, despite its comparative rareness in developed nations, is the young age of women afflicted by it. While cervical cancer accounts for a smaller number of total cancer deaths, it makes up a larger number of fatalities in women under forty. As a result, there is a greater feeling of senselessness with each loss of beautiful, vibrant girls and women cut down in their prime. Doctors promoting the shot emotionally recall patients who never had a chance to realize their life’s promises. One Canadian doctor described a young talented pianist, who “after years of dedicated study, was scheduled to give her first piano recital in Toronto.”
⁷⁰
Alas, this young woman ignored irregular discharge until it became unusual bleeding. By that point it was too late, and she died within months.

HPV vaccines have been approved in some countries for use in women between twenty-seven and forty-five as well as in their younger sisters. The FDA rejected Merck’s bid to extend their approval in the United States.
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This was due in part to a lack of evidence that older populations, the vast majority of whom are sexually active, will see any health benefit from the shot.
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In Australia, where use in older women was approved for Cervarix, the controversy was no less pronounced: Dr. Gerard Wain wrote in the
Medical Journal of Australia
that “to suggest that the vaccine will offer patients some theoretical potential benefit if they are prepared to pay
for it does not reflect sound evidence-based, equitable, health-care provision.”
⁷³
In other words, if you are already having sex, it is possible that the shot will bring no benefit and certain that Pap smears and other screening tools remain your best strategy for cancer prevention. Gardasil for grown-ups isn’t dangerous but is more akin to a four-leaf clover than a magic bullet. Women over twenty-six in America can still get Gardasil, but as an off-label prescription, they have to pay out of pocket for it.
⁷⁴

Those who opt to seek out Gardasil on their own may find it difficult to locate doctors offering the injection. Because of the high price, many have been reluctant to offer Gardasil, equating having the product with “handling expensive crystal with no margin for error.”
⁷⁵

Even for those whose insurance companies cover Gardasil, it may be difficult to seek compensation. Most insurers pay part of the cost for women who fall within the FDA-recommended age group, while some cover only administrative costs.
⁷⁶
Insurance company inconsistency about reimbursement makes some doctors less likely to carry the vaccine. Slow uptake of the vaccine, coupled with the poor economy has caused Merck to cut its sales estimates by $500 million. To compensate, the company is pursuing other ways of expanding sales, “such as reimbursing doctors who give the vaccine to uninsured patients.”
⁷⁷

Parents, Schools, and the Battle over HPV Vaccination

Alarms sounded around the globe when, in the spring of 2007, a group of Australian schoolgirls experienced mysterious adverse reactions, including fainting and paralysis, after being injected.
⁷⁸
Ian Frazer, the Australian inventor of Gardasil, unwisely portrayed these incidents as psychosomatic or hysterical. Australian women’s health activists responded by chastising this assessment: “We shouldn’t dismiss the bad experience of these girls just because we really want the vaccine to work. Women’s health is more important.”
⁷⁹

In America, a conservative group called Judicial Watch used the Freedom of Information Act to gain access to adverse event reports, which they then revealed to the public with sensationalist gusto. The 1,637-page report (which covered 136 serious side effects and a small number of
deaths) was described by the organization’s president, Tom Fitton, as “a catalog of horrors.”
⁸⁰

Parents’ initial optimism about Gardasil shifted to wary caution. Ontario’s enormous opt-in program, which offered the vaccine to girls for free within an approved age group, began to fail. An early survey of parent attitudes toward the shot had found high approval, with 75.3 percent claiming they intended to give their daughter Gardasil.
⁸¹
By November 2007, it was clear that perspectives had changed, and vaccination rates in Ontario were under 50 percent.
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Journalist André Picard observed that part of this parental resistance might be due to governmental “hard sells”: “The hallmark of public health communications has, for far too long, been proselytizing, ‘If we say everyone should have the vaccine, everyone should have the vaccine, trust us.’ ”
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This sort of paternalistic approach might have worked fifty years ago, Picard notes, but in the age of the Internet, health consumers are educated enough to want to see the evidence.

In 2008, there was more bad news: two girls in Europe—one in Germany and another in Austria—died unexpectedly after receiving Gardasil. As with previous deaths in the United States, the European losses were associated with, but not tied to, use of the vaccine.
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The European Medicines Agency felt compelled to review the vaccine’s safety and announced that while it found that adverse events occurred, the two deaths could not be definitively shown to be the result of Gardasil and that the benefits of getting the shot outweighed the risks.
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Still, it threw gas on the fire. Parents began asking questions very loudly that ranged from reasonable to outlandish: Would Gardasil lose effectiveness with the years? Could it cause reproductive problems or infertility?
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They worried about birth defects and chemicals like aluminum in the vaccine causing degenerative diseases.

By 2008, Judicial Watch again raised the issue of more than eight thousand adverse events and seventeen deaths.
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While the FDA reports “cleared” the vaccine from responsibility in most of the fatalities, today the question remains: does Gardasil cause more—or more serious—side effects than other common vaccines? Some sources say yes. An article published in
CMAJ
on September 1, 2008, noted that anaphylaxis (allergic reaction) is five to twenty times higher with the HPV vaccine than other vaccines,
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but added that overall adverse event rates “were very low.”
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Others interpreted the
CMAJ
data differently, arguing that “although there may be underreporting, the rate … is consistent with the rate of anaphylaxis following several other vaccinations.”
⁹⁰

Whatever the reality of shot-related side effects turns out to be, the FDA saw fit to expand warnings on the vaccine’s packaging in June 2008 to include “joint and muscle pain, fatigue, physical weakness and general malaise.”
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Two months later, the
Medical Journal of Australia
reported that some patients had experienced pancreatitis after getting the shot.
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In the winter of 2008 the total number of adverse events in America was over nine thousand and included twenty-seven deaths. A pharmaceutical industry publication noted that 20 percent of all vaccine adverse events in 2008 were related to Gardasil, despite the fact that it isn’t required like many childhood vaccines.
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We must ask the same question about Gardasil that we ask about all vaccines: is the illness serious enough to warrant the risks and side effects? It is important to put in perspective that most adverse events were not serious, and some of the more serious complications—like Guillain-Barré syndrome, a rare condition where the immune system mistakenly attacks the nerves, potentially causing paralysis
⁹⁴
—have been seen in other vaccines as well as in allergies to ingredients such as egg protein and gelatin.
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Gardasil doesn’t seem to increase patients’ risk of getting the disorder. Lingering pain at the injection site
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is also common with many vaccines. Fainting and hyperventilating are more serious and suggest a need for extended monitoring of patients after injection to prevent injury from falling.
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Potential paralysis and blood clots could potentially be deeply worrying, but so far these conditions haven’t been definitively tied to the shot (in several deaths, Merck has been quick to point out that patients were also on oral contraceptives, a more likely culprit for clotting and cardiac events). Still, even the hint of a connection to these life-threatening conditions makes it worthwhile to ask how serious the cancer risk is to begin with if patients are already participating in an annual program of cervical screening. Until we are sure what problems the shot can cause, it is always valuable to use precaution in making decisions for our own health and the health of our children.