Select Top Stories From Herizons

On Guard Against Gardasil  by Dawn Rae Downtown
On Guard Against Gardasil

Several years ago, I oversaw Planned Parenthood British Columbia’s 40 public health clinics. A big part of the job was to help contain the spread of sexually transmitted infections, including the two strains of human papilloma virus associated with about 70 percent of cervical cancers.

The human papilloma virus is the world’s most common sexually transmitted infection among women and men alike. About 200 different strains of the virus that have been identified to date. There is a good chance you’ve already had it—me too.

Fortunately, 90 percent of those who are infected will throw the virus off within a year or two. Still, on are occasions, the virus persists and a woman may develop cervical cancer. She will have missed a Pap test that would have detected it, or her Pap may have failed to detect it. At Planned Parenthood, we knew that condoms and Paps could stop the virus in its tracks. But we also knew that our young patients were notoriously immortal. Young women were unreliable about getting their Paps, just as they were about using condoms.

So you’d think I’d be thrilled now that Merck has manufactured Gardasil, the first ever vaccine approved for some strains of the human papilloma virus, and now that Ottawa assigned $300 million in its March budget for a program to vaccinate Canadian girls aged nine to 13. But count me out. The inoculation proposition and the vaccine come freighted with too many questions, many of which have yet to be widely asked, let alone answered.

Valerie Regehr of the Women’s Health Clinic in Winnipeg calls the knowledge base that supports the use of Gardasil “unstable,” while the editors at the U.K. science journal Nature Biotechnology put it this way: “in its rush to market its vaccine, Merck forgot to make a strong and compelling case for compulsory immunization.”

Here are just some concerns. Many health experts fear that a vaccine that targets some high risk strains of the human papilloma virus could lull women into a dangerous complacency—they may believe they’re immune from cervical cancer or from all sexually transmitted infections.

“I’m very concerned that women will think they’re safe,” says Madeline Boscoe of the Canadian Women’s Health Network. Boscoe worries that vaccinated women may not keep up with their Pap tests, or may mothball their condoms. Linda Capperauld of the Canadian Federation for Sexual Health agrees. She says Ottawa seems to lack a comprehensive general strategy for women’s reproductive health. Canada’s three reportable sexually transmitted infections (chlamydia, gonorrhea and syphilis) have all increased substantially over the last 10 years, she notes.

Chlamydia and gonorrhea rates have almost doubled. In a climate of increased infections, Capperauld says Gardasil “feels like a quick fix to a much more complicated issue.” Women’s health advocates worry that an emphasis on a vaccination program could displace resources for cervical cancer screening and other reproductive health initiatives.

“We’re concerned that needed investments and supports for Pap testing may not go ahead,” says Regehr.

In Canada, we already have highly effective screening and treatment for cervical cancer. Our cervical cancer rates have declined by 50 percent in the last 40 years due in large part to regular Pap testing, while cervical cancer death rates have declined 60 percent. Condoms and Paps are effective, proven ways of protecting women’s health.

Condoms protect not only against HPV, but against all sexually transmitted infections. According to a paper published in the August 2007 edition of the Canadian Medical Association Journal, “information about the efficacy of Gardasil appears promising, but remains uncertain.... Related to this are other unknowns about the vaccine's effectiveness in the ‘real world,’ including the possible need for booster shots... and the impact of vaccination programs on safer sex practices and Pap screening rates.”

Since Gardasil hasn’t been studied long-term, no one knows whether any immunity it confers will last. Merck’s clinical trials followed 20,000 females for an average of four-and- a-half years. Just 241 subjects were followed for five years and none were followed for longer. The youngest girls were followed for only 18 months and were not significant in the study group in any case: only 100 nine-year-olds were included. Nonetheless, nine-to-13-year-olds are now recommended for vaccination in Canada. (They are assumed not to be sexually active or infected, although many types of human papilloma virus infection have been found in children, even in newborns.)

“It’s scary,” says Boscoe of the Women’s Health Network, “to think of vaccinating a whole generation of nine-year-old girls in this country based on a hundred.” She advises caution from parents and from government. “The duty around evidence here should be so much higher.”

Cervical cancer, rare and slow-growing, is hardly a public health emergency. Gardasil will only replace interventions we already have. So why is Ottawa keen on it? In the run-up to the March federal budget, the Gardasil lobby was intense. Merck’s “Tell Someone” ad campaign on national television was hard to miss, night after night through January and February. It featured girls and women musing about “the cervical cancer virus.” By means of what appeared to be a public service message, Canadians suddenly knew more than they ever had about cervical cancer and the human papilloma virus.

Or did they? Making cervical cancer seem far more pervasive and dangerous than it is (first-rate screening and treatment has made cervical cancer one of the lowest cancer threat in the country), the commercial seemed to be more about creating a market than about creating awareness.

Linda Capperauld of the Canadian Federation for Sexual Health laments the lack of coherence that attended the Gardasil campaign. “Women, and young men, too, are still not getting the education and the information they need to understand their bodies, and the choices they’re making, and how to protect themselves,” she says. “There was no acknowledgement that HPV is only one sexually transmitted infection of several, no acknowledgement that there are ways to prevent it—condom use, Pap testing.”

“It created a lot of anxiety and distorted facts,” adds Boscoe. “It suggested there was a cervical cancer epidemic in Canada, and that a vaccine could cure it.” The reason that 400 women died of cervical cancer last year wasn’t that the public health system didn’t know what to do, she says. “They died because we weren’t caring for them. Either they didn’t come in for care, or we didn’t follow up on them.”

The women most at risk of cervical cancer, in the West and around the world, are poor. In Canada, they may be immigrants or Aboriginal women with language and cultural barriers, or they may be isolated, living with disabilities or be women whose immunity is compromised by stress and poor nutrition. “But it doesn’t mean that we can’t get to them,” says Boscoe. “Given that we know something about who it is we’re not serving, we could put our efforts there.”

The Canadian HPV Research Priorities Workshop, a federally sponsored congress of experts that met in Quebec City in late 2005, concluded that coherent goals and models for HPV mass vaccination were not in place, and that “many questions need to be answered before administration of the new vaccine can be justified.” Nonetheless, Health Canada approved Gardasil for females between nine and 26 in July 2006, the same month the U.S. Food and Drug Administration approved it. The American Academy of Family Physicians now recommends that girls 11 and 12 receive the vaccine. The National Advisory Committee on Immunization in Canada supports the vaccine for girls and women between nine and 26, with some conditions.

Merck’s campaign began in earnest when the company appeared before the House finance committee during prebudget consultations last October. The company was introduced at the hearings by Dr. Diane Francoeur, the head of the Association of Obstetricians and Gynecologists of Quebec, a physicians’ group that receives financial support from Merck. Another physicians’ group with ties to Merck, the Federation of Medical Women, lobbied hard on the company’s behalf just before the budget came down. Merck spokeswoman Sheila Murphy says the company has been “delighted” to work with doctors on Gardasil, as well as with lobbyists.

One of those lobbyists was, until recently, a senior policy advisor to Prime Minister Stephen Harper. Murphy adds that the company’s relationship with the physicians’ groups it supports is part of the responsibility Merck has to provide Canadians with information on cervical cancer.

Perhaps it is. But wouldn’t we find the information more reliable if it didn’t have purse strings attached? “Companies have the right to push their drugs and devices into the market,” says Boscoe. “But public interests are about evidence, and about answering these questions before a penny of public money is spent.”  

  Dawn Rae Downton is a writer living in Halifax. This article first appeared in Herizons Fall 2007 issue.