In Our Control (39 page)

Perhaps because it wanted to establish its product as the industry leader, earn government contracts, and build brand recognition before Cervarix had a chance to catch up, Merck launched a shock-and-awe campaign to have Gardasil accepted as the best standard of care. The aggressive marketing effort employed several strategies. First, it worked
with women’s groups like the bipartisan Women in Government to pressure female lawmakers to push the vaccination.
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Second, it launched a powerful direct-to-consumer advertising campaign that targeted both young girls and their parents. Ubiquitous images of strong, energetic women engaging in a range of activities and triumphantly proclaiming “I’m gonna be one less! [victim of cervical cancer]” graced television screens, and advertisements played on the Web site
YouTube.com
and in movie theaters before summer blockbuster films.
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Third, Merck began a program of physician education, hiring doctors to give lectures to their peers for substantial sums of money (as much as $4,500 per talk).
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It wasn’t just that Merck wanted to trounce GSK before the latter brought its product to market. Merck also wanted to fix some of its own lingering financial and public image problems, not the least of which was its huge legal debt and market loss incurred after the blockbuster second-generation nonsteroidal anti-inflammatory drug (NSAID) Vioxx was pulled for contributing to cardiac problems and death in users. Only a year after its approval, Gardasil was going a long way to helping Merck erase this painful history with one billion dollars in profits.
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As a writer for Bloomberg News noted, “The recall of the Vioxx painkiller … cut 31 percent for the shares in three months,” adding, “Profit may rise in 2007 for the first time in three years.”
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It wasn’t long, though, before it became clear that the pharmaceutical giant and their allies were striking a sour note with the public. For one thing, any questions raised in the media about Gardasil, any suggestion that the shot was less than an unqualified miracle were met with ridicule. Abby Lippman, a professor of public health, was the lead author of lucid, stinging piece in the
Canadian Medical Association Journal (CMAJ)
that posed serious questions about HPV vaccinations even as it acknowledged the tremendous health barriers the new technology crossed. The response was fast: Lippman “was vilified in Salem-witch-trial manner for failing to toe the party line”
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with scathing letters to the editor from doctors and public health authorities as well as articles and commentary in other news outlets that painted the activist as a crazy health alarmist. As one Canadian journalist noted, “Whether you agree with the point of view or not, she did what scientists should do: ask questions.”
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An even more direct example of drugmakers seeking to suppress contrary
opinions happened in Australia, where a university professor was reprimanded and ordered to apologize to CSL, the Australian firm that created Gardasil and licensed it to Merck, for making negative comments about the vaccine. Professor Andrew Gunn, a senior lecturer at the University of Queensland, had expressed his views on national radio, noting that Gardasil’s problems included “its marketing as a solution to cancer of the cervix when at best it’s expected to prevent about two-thirds of cases; the incorrect and dangerous perception that it might make Pap smears unnecessary; and the difficult question of the best age to give a vaccine whose effect might yet prove to wear off before many recipients even start having sex.”
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Each of these caveats is legitimate and far from radical. It will be decades before efficacy rates are available for cervical cancer prevention. During this time women may desert other screening methods if they believe they are safe without them. Finally, the duration of the vaccine remains an open question. These concerns had been voiced by doctors and health experts in major publications including the
Journal of the American Medical Association
and
CMAJ
. But the University of Queensland, which had a financial and research relationship with CSL, ordered the professor to issue a mea culpa.

Clarifying the Objectives of HPV Vaccination

Part of the problem in the beginning was that while Gardasil was a vaccine, Merck marketed it like a drug. Didier Hoch, president of Merck’s joint venture with French drugmaker Sanofi-Aventis, noted, “In most countries, Gardasil is becoming accessible at the speed of a pharmaceutical drug, which is a first for a vaccine.”
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While drugs tend, for better and often for worse, to burst onto national scenes, demanding attention and rapid acceptance, vaccines usually follow a slower course, often taking five to ten years to gain universal acceptance. They also tend to utilize public health channels, like vaccination programs, for administration rather than promoting themselves directly to potential consumers. The
New York Times
stated, “The lightning-fast transition from newly minted vaccine to must-have injection in the United States and Europe represents a triumph of what the manufacturers call education and their critics call marketing,”
adding, “In two years, cervical cancer has gone from obscure killer confined mostly to poor nations to the West’s disease of the moment.”
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This hybridization confused the public. Generally, vaccines are seen as a “greater good” measure, where individual choice and need are sublimated for the betterment of the community. This is because typically, the infections prevented by shots are transmitted through casual contact and are not effectively treated with other methods. Vaccines are used broadly in the population to gain so-called herd immunity. In other words, if enough people in the population become resistant to a disease, in time there will be no one to catch it from. When it comes to potentially fatal diseases such as smallpox, the needs of the community as whole trump individual concerns.

But as we know, HPV isn’t transmitted by casual contact. As Abby Lippman and her colleagues put it, “Is the aim of the vaccination program the eradication of high-risk HPV types from the population? Or is it to reduce the number of deaths from cervical cancer? These different goals require different strategies.”
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Ian Frazer clearly takes the earlier perspective, equating the shot with Jonas Salk’s polio vaccine.
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Echoing Frazer’s “big picture” approach, many media outlets often convey the message that Gardasil is about obliteration: one Australian paper explains that “the new cervical cancer vaccine is expected to almost eradicate human papilloma virus (HPV) infections in Australian women by 2050 if the high rate of immunization amongst girls continues.”
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While this would indeed be a noble goal, it is unlikely for many reasons. Even if herd immunity were possible—and this is a controversial point—Gardasil is only effective against four strains of HPV: 16, 18, 6, and 11. The first two are indeed serious infections, accounting for up to 70 percent of cervical cancers. However, there are at least forty known strains that can cause cancer, and neither Gardasil nor Cervarix provide such complete protection against dangerous HPV strains that there is no longer a need for further and continuous screening.
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In this context, HPV vaccinations fall somewhere between Salk’s polio vaccine and a yearly flu shot.

Many prominent health officials are quick to affirm that the vaccines won’t broadly eliminate the disease. Catherine DeAngelis, editor of the
Journal of the American Medical Association
, notes, “The HPV vaccine
does not create herd immunity, although it would probably reduce the prevalence of HPV infections.” She adds, “The primary justification for HPV vaccination is to protect women from long-term risks, rather than to prevent immediate harm to others.”
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For Lippman, this confusion of issues isn’t accidental; it is a deliberate effort on the part of drugmakers to burn the candle at both ends, to take advantage of public desire to do something good for womankind while also exploiting drug marketing techniques that speak to individual preventative health desires. In her estimation, it is an effort to “confuse the issue of epidemics with details of the ways in which women with cervical cancer suffer.” In other words, cervical cancer is terrible, but the pain of women who battle it shouldn’t be exploited to promote false notions of Gardasil’s efficacy. As another activist notes, “There’s nothing wrong with drug makers publicizing their products, but the lure of lucrative government contracts can prompt them to play fast and loose … Merck has greatly exaggerated both the threat of the disease and the ability of [Gardisil] to prevent it.”
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Syringes and Surrogate Endpoints: Gardasil and the Race to Stop Cervical Cancer

Efficacy questions have plagued both HPV vaccines since their introductions. These include serious uncertainties about how effectively the shots prevent both HPV and cancer, and how long their protections endure.

Clinical trials have measured success with surrogate endpoints. That means the trials compare the HPV rates of women who have received Gardasil shots to those of a control group of women who didn’t receive the vaccine. Because cervical cancer is so predictable—that is, because we know how to identify dangerous cells well before they progress to cancer—it would be unethical to let women who develop certain abnormalities progress without treatment.
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Instead, scientists use a “surrogate,” an indication that cancer may be coming, to assess if the shot has made an impact. In this case, they measure lesions that develop from irregular cells.

This is complicated because it is estimated that 40 percent of these lesions disappear on their own.
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It is likely that many of the “cancers” seen in trials
would have resolved—and created natural immunity—without need of intervention. Because of this it will take at least a decade, and perhaps several decades, to determine whether the shot actually prevents cancer.
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Surrogate endpoints can provide only an idea of real-world effectiveness.

The announcement that HPV was a hair’s breadth from being cured came as a surprise to many who were either unaware that the illness existed or unconcerned about contracting it. I first learned of HPV in high school when I heard a religious commentator on television comparing it with HIV, declaring with certainty that if teenagers knew of this scourge, they would never have premarital sex. The most frightening part of the preacher’s message: he warned that HPV couldn’t be stopped with condoms like other STIs.

In fact, HPV is still dramatically underdiscussed in conversations about sexual health, particularly with young people. Pregnancy, AIDS, and even other common STIs like gonorrhea, chlamydia, and herpes get more attention, despite the fact that HPV is the most common sexually transmitted infection.

The dearth of education likely has at least two major causes. The first is that HPV is usually symptomless (although some strains can cause genital warts). Cancer takes years (sometimes decades) to develop and is a rare outcome. The second major reason that parents aren’t trying to frighten teenagers about HPV is that around 90 percent of infections resolve on their own within one to two years.
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Like most viruses, once it has been fought off, the body is immune to whichever strain it previously suffered from.
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While more than 90 percent of HPV will never even progress toward cancer, let alone actually become malignant, more than 99 percent of cervical cancers are believed to be caused by HPV.
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There are, unfortunately, many strains of the virus. Estimates range from 150 to 1,000. Of these, around 40 are known to cause cancer,
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and types 16 and 18—the two strains fought by both Gardasil and Cervarix—are responsible for up to 70 percent of cancers.
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So while the HPV vaccinations target only a very small number of possible virus strains, they do target the forms of the virus thought to be most dangerous. Because neither vaccine accounts for all cancer-causing strains, it is essential that women continue having regular Pap smears or comparable viral screening throughout their lives, regardless of vaccination status.

The virus acts by entering cervical cells and shedding its DNA. The infected cells begin producing viral proteins and spreading the infection. Such growth, if it continues for years, can become cancerous. The vaccine works like most vaccines: it introduces proteins that mimic the viral ones—not enough to cause illness, but enough to trigger the body to produce antibodies preemptively. If the body comes in contact with the virus later, it is prepared to fight it off.

It is estimated that 50 percent of sexually active people will contract HPV at some point in their lives, 6.2 million in America each year.
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A study published in the
Journal of the American Medical Association
in 2007 found that HPV rates increase in a given population between ages fourteen and twenty-four, after which point they slowly but steadily decline through age fifty-nine.
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The study calculated several statistics important to the Gardasil discussion. First, it found that around 26.8 percent of women in the United States are infected with the virus at any single moment, with the highest percentage at between ages twenty and twenty-four (44.8 percent). This percentage was closer than expected to the rate of infected women found in studies of vaccine efficacy among sexually active women. In other words, it suggests that vaccination has limited benefits for women who are already having sex. Second, study authors noticed that while overall infection rates were high, very few women suffered from types 16, 18, 10, and 6—the strains targeted by the vaccines. In fact, only 3.4 percent of infected women had any of the four, and of the high-risk strains 16 and 18, rates of infection were 1.5 percent and .8 percent, respectively.
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A 2007 trial found that the vaccine didn’t help women who had already been infected recover more quickly, nor did it help treat prior infections.
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