In Our Control (38 page)

What is the truth about this novel option in women’s health care, and how can we separate the medical realities from the important social contexts and histories that surround and threaten to overwhelm them? How can we move toward an understanding of HPV vaccination that both appreciates its awesome potential and is realistic about its unanswered questions and limitations? In a book about contraception, it may seem strange to focus on a health measure that has nothing to do with preventing pregnancy. However, HPV vaccination is an important new option in the world of sexual health, and the story of this shot holds lessons for women in other health contexts.

The Smear vs. the Stab: Cervical Cancer Prevention from Papanicolaou to Frazer

If the new HPV vaccines entered the world with a bang, the most successful anticancer intervention to precede it—the Pap smear—entered with a whimper. George Papanicolaou, a Greek doctor and reproductive scientist, noticed something unusual while examining exfoliated vaginal cells in an attempt to map reproductive cycles. The doctor realized that abnormal cellular growth—the sort that led to cancer—could be identified. Perhaps, he reasoned, cervical cancer could be predicted based on these changes.

Papanicolaou took his discovery to a prestigious eugenics conference in 1928. In retrospect, he was doomed from the start. Among other problems, his paper was riddled with errors; for example, instead of the word “cancerous,” he wrote “conscious.”
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Conference attendees were lukewarm on his bold new theory, and Papanicolaou would have to wait another thirteen
years—until 1941—for the full impact of his work to be understood. In his classic paper published in the
American Journal of Obstetrics and Gynecology
,
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Papanicolaou again suggested that observing cervical cells for changes and abnormalities could be a way to forecast the emergence of cancer.

If 1941 brought enthusiasm for this idea, it also brought controversy. Pathologists didn’t like the test because it was time consuming and imprecise. Gynecologists, however, were enthused, and by 1945, the procedure was being advised by the American Cancer Society. Still, adoption of the smear into routine practice was slow. Many doctors resisted offering “Paps,” and many patients didn’t want them anyway. A 1961
New York Times
article revealed that two fifths of American women had never heard of the test, and even more felt it was unnecessary.
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Today, of course, the Pap smear is an American institution. It is estimated that 86 percent of women between eighteen and sixty-four
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have put their feet in the stirrups at least once and let a doctor scrape a few cells from their cervix. For most women, it is a yearly ritual akin to—although certainly not as joyful as—a birthday. The result has been astounding and has transformed cervical cancer in the developed world from a scourge to a relatively uncommon event.

Certainly women still die of cervical cancer: in 2005 in the United States, 11,999 women were diagnosed with the illness and 3,924 died from it.
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The death rate is approximately 1,100 in the United Kingdom, and around 400
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women succumb each year in Canada.
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Compare these tragic but modest numbers with the international death rate from cervical cancer—more than 237,000 each year, making up 9 percent of female cancer deaths
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—and you begin to get a sense of how different the illness is for women depending where in the world they live. In America, of the several thousand women who die each year, 60 percent have either never had a Pap test or haven’t had one within five years of their diagnosis.
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In the developing world it is a very different picture, and cervical cancer is still a leading cause of cancer death. Because annual exams require constant and repeated access to health care services, reaping their benefits remains a significant challenge for women in poor nations.

Recent years have brought new screening techniques, including genetic testing for HPV and liquid Pap tests. These screening methods are still in development, but they may eventually prove practical and cost-effective
alternatives to annual Pap smear screenings for many women.
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Still, annual screening remains one of the most successful cancer interventions of all time. As bioethicist Sigrid Fry-Revere notes, “The American Cancer Society sees its fight against cervical cancer as a success story even without Gardasil. When the disease is detected early through Pap testing, the survival rate is more than 90 percent.”
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When a woman has a Pap smear, her doctor scrapes a small amount of tissue from around the cervix. In a traditional smear, the cells are examined by a skilled technician and checked for changes or abnormalities. For most women, having a Pap smear is the best option right now for cervical cancer screening. Newer liquid-based Pap smears add samples to liquid and use machinery to separate cervical cells from blood mucus and debris before examining them. Liquid smears may be better at finding certain types of cancer, and they offer the option of having a simultaneous test for HPV with the same sample. But liquid tests are also more expensive, and the difference in cost from a traditional Pap smear may not be covered by insurance. They also produce more false positives, especially if a woman is very young or taking oral contraceptives.

An HPV test, which also involves analyzing a cervical swab, examines DNA to check for thirteen types of the HPV virus. While in some ways the HPV test is more sensitive, the Pap test is more specific.
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Because of this, if a woman’s insurance covers both, the tests can be partnered so that one test catches what that the other misses. The American Cancer Society notes that the HPV test isn’t usually recommended for women under thirty because HPV in this community is so common
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and in most cases resolves on its own without intervention. But for older women or young women with unclear Pap smear results, it is a valuable tool whose unique advantages are coming to be understood.

The Pap smear may yet have room for improvement, but the test is already so precise that the National Institutes of Health have eased their test frequency recommendation from every year to every three years if a woman has had three consecutive normal smears. Still, many women continue to have them annually, and there is nothing wrong, safety-wise, with that.

The Approval and Selling of Gardasil

Flash back to 1991: Scottish-born biochemist Ian Frazer was conducting research at an Australian hospital in Brisbane. He and colleague Jian Zhou realized they had found a way to create a vaccine for HPV.
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The original project was designed to take five years; it took a little longer but still progressed with great momentum. Indeed, the HPV vaccination would both benefit and suffer from the lightning speed with which it entered international medical consciousness. In the end, Frazer and Zhou’s work would become the basis of two HPV vaccines: Gardasil and Cervarix.

Perhaps it all went so fast because the story of HPV vaccination is that of a race between rival drugmakers to corner the market on a potentially radical new technology. The contest was between two fierce competitors: on one side was Merck, with a quadrivalent vaccine—a shot that resisted four strains of HPV. On the other side was the British pharmaceutical giant GlaxoSmithKline (GSK), whose shot, Cervarix, offered protection against only two strains of HPV but promised stronger protection against them. GSK had been working on their shot for a longer period of time, but Merck beat them to the market. After reviewing four clinical trials,
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the FDA voted to give Gardasil the green light on June 8, 2006.
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Health Canada followed on July 18, 2006.
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It would be another nine months before GSK submitted their application to the FDA. When they did, GSK insisted that clinical trials would prove their product superior.
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Two years later, Cervarix finally received approval in the United States in October 2009 and is now recommended by the Centers for Disease Control and Prevention (CDC) for use in American women, as well as in the European Union
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and the United Kingdom (where this British product is offered to young girls at no cost through the National Health Service). GSK has a lot of ground to make up, and perceptions that their shot simply does less by protecting against fewer strands of HPV and not offering protection against genital warts is a serious obstacle to overcome. Still, the CDC’s Advisory Committee on Immunization Practices declined to recommend Gardasil over Cervarix.

The FDA’s 2006 approval of Gardasil was for girls between the ages of nine and twenty-six. This meant that older women would have to pay out of pocket for the shot with no hope of insurance reimbursement. In the
same month that the FDA approved the vaccine, a CDC advisory panel voted unanimously to recommend the vaccination for all girls aged eleven and twelve.
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Panel members explained their decision, noting, “Despite the seemingly high cost … all of the cost-benefit analyses the committee reviewed showed that the vaccine was a cost-effective intervention.”
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Such confidence in the affordability of HPV vaccination was surprising given that Gardasil had just become the most expensive vaccination in history with a price tag of $360 for all three suggested doses.

While the CDC panel recommended Gardasil, it never suggested that the shot be mandatory. Even if they had wanted to require it, they couldn’t have; the ability to compel a vaccination belongs to individual states, and there is no national immunization law in the United States.
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Curtis Allen, a CDC spokesman, noted that it was never CDC’s intention to force Gardasil on women; rather, the goal was to spread the good word about its potential benefits. Indeed, he insisted, mandatory programs usually take years to build: “In the past, mandates have generally been enacted several years after a vaccine is introduced and recommended.”
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Despite this, many states and lawmakers interpreted the FDA and CDC’s fast embrace as a call to action. In September 2006, a rapid ninety days after approval, Michigan became the first state to propose requiring Gardasil as a prerequisite for school admission, and Texas governor Rick Perry issued an executive order calling for mandatory school vaccinations. In short succession, twenty-three state legislatures created bills to require that Gardasil be administered to their girls.

As quickly as these schemes were rolled out, they were rejected, overturned, and rolled back in. Texas passed a bill blocking Perry’s order
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after it was revealed that he and other state legislators collected $44,000 in contributions from Merck-hired lobbyists.
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Other states, particularly in more religious parts of the South, rejected plans on grounds that they might seem to condone teenage sexuality. Others buckled under mounting public pressure from parent and patient advocacy groups.

Most of the proposed programs were opt-out alternatives—in other words, parents could block their children’s vaccinations on religious or ethical grounds, but the assumption was that unless otherwise notified, schools would expect girls to be vaccinated. In the end, only Virginia’s mandatory plan held—with a very liberal parental objection clause. The
rewards for Virginia’s compliance demonstrate the way that pharmaceutical makers can use financial incentive to influence public policy: only months after Virginia governor Tim Kaine signed the Gardasil legislation, Merck pledged to pour $193 million in additional funds into its Elkton, Virginia, plant where the vaccine is manufactured.
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New Hampshire pursued an alternate opt-in approach with great success. Instead of requiring young girls to be vaccinated, the state made Gardasil optional and free for anyone between the ages of eleven and eighteen.
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The results were overwhelming: within months, doctors were unable to fill all the requests for vaccination. It wasn’t a perfect system; for one thing, the program consumed a large percentage of the state’s immunization budget, taking funds away from other shots. Another problem was that insurers refused to pay for shots in girls who fell within the free age group, creating further stress on the already overtaxed system. Still, the New Hampshire case proved instructive for other states, including South Dakota and Wyoming, which created similar programs.

The Canadian government allocated $300 million for Gardasil, and provinces rushed to design programs. Ontario was the first, with a massive opt-in program designed to make the shot available to eighty-four thousand eighth-grade girls.
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Women’s health activists balked at the speed with which these strategies were enacted and pointed the finger at drug company maneuvering. Anne Rochon Ford, coordinator of the group Women and Health Protection, noted, “It is staggering how quickly and secretly this has all happened and that points to some pretty active footwork behind the scenes.”
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At the same time, Britain raced to create a program that would work in their National Health Services. While a program for twelve- and thirteen-year-olds (with catch-up plans) wouldn’t be put into place until the end of 2007 and implemented the following year,
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many parents began paying out of pocket for daughters’ shots. Australia, creator of and one of the first nations to embrace Gardasil, offered the shot free to women between thirteen and twenty-six until June 2009.
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