Who's Afraid of Gardasil?
A nonprofit called Women in Government, comprising female state legislators, has been behind the push to make the vaccine compulsory, educating members about its value and urging them to introduce bills in their respective states requiring the shots--even going so far as to offer sample wording for the legislation on its website. It turns out Merck--whoops!--was a big WIG donor.
Fueling everybody's mistrust was Merck's own image problems. As maker of the arthritis drug Vioxx, which may have been responsible for 28,000 deaths before it was withdrawn from the market in September 2004, Merck was, well, suspect. Especially since it stands to make a bundle by charging $360 for each shot series. And it has a motive to corner the market quickly: GlaxoSmithKline is hot on its heels with an HPV vaccine of its own that it hopes to introduce before the end of the year. What's more, if it's lucky Merck stands to double its money. When seeking approval for the vaccine, the company also submitted data on clinical trials for Gardasil and boys. Though the vaccine thus far appears safe for young men, it may be more complicated to prove it effective--and to sell to parents. (After all, the cancer-preventing imperative is more circuitous: Boys aren't the ones being protected from cancer; their future partners are.)
In an effort to defuse the controversy, Merck backed off a bit in late February, issuing a statement saying, "We are pleased that Gardasil has been so widely embraced and do not want any misperception about Merck's role to distract from the ultimate goal of fighting cervical cancer, so Merck has re-evaluated its approach at the state level and we will not lobby for school requirements for Gardasil."
Enter the antivaccine groups, which had been waiting in the wings for the big break that finally arrived with Merck's public whipping. These groups, an eclectic mix of alternative medicine proponents, conspiracy theorists and libertarians, form a growing contingent of parents who are refusing to vaccinate their children against any diseases. They have assailed the HPV shots and, because their network of skeptics was already in place, were able to serve up outspoken critics on the spot to eager reporters. "Our concern is that this vaccine has not been studied long enough, or in enough children, to start mandating its use," said Barbara Loe Fisher, who heads the National Vaccine Information Center, a self-described organization of "parents of vaccine-injured children." This group, which according to its website pretty much opposes every vaccine mandate for every reason it can muster, strongly objects to this one being a requirement of school entry for sixth graders. "This is particularly egregious because HPV is not a disease communicated in a school setting like other diseases with mandatory vaccines," Fisher says, insisting (nonsensically) that this negates the government's "compelling interest" in curtailing HPV.
Those who work in public health were not blindsided by these critiques from the antivaccine organizations--and in fact have been worriedly monitoring the swelling ranks of vaccine opponents for several years now. "Vaccines have raised concerns for similar reasons throughout history," says Greg Zimet, a professor of pediatrics and clinical psychology at Indiana University School of Medicine who served on the Society of Adolescent Medicine's HPV committee. (The society strongly endorses the vaccine and is confident of its efficacy and safety but has not yet formally weighed in on the mandating issue.) When you consider that only a century ago infant mortality in the United States was 20 percent and another 20 percent of kids died before the age of 5, according to a 2005 article in the journal Health Affairs, the critical role that compulsory vaccination plays is clear; the infant mortality rate today is less than 1 percent. "But vaccines are their own worst enemy," Zimet says. "When they work, they reduce the element of risk to almost negligible. Who knows anyone who has ever had diphtheria or polio today? Take the deadly diseases so far out of the equation, and these parents will focus on what the vaccine's side effects may be."
Pointing out that as many as 3 percent of US children are no longer being vaccinated against any disease because their parents object (a number that jumps as high as 20 percent in some school communities), Zimet says public health officials and pediatricians worry that the positive effects of what they call "herd immunity" are already being compromised. Because there is a class of people for whom inoculation poses a health risk--those with AIDS or a host of other illnesses, for example--requiring that everyone else be vaccinated can help protect these populations as well. That's how the government justifies mandating immunization.
But, like many of the rifts that divide our civic conversations into opposing camps, the vaccine debate pits individual rights against group rights--and some parents are hopping mad. It's here that Fisher's antivaccine group marches in lockstep with antigovernment libertarians. Both insist that making the HPV vaccine compulsory violates their parental rights. "We are not against vaccine availability, just vaccine mandates," says Fisher. While she concedes that every state but two has some kind of opt-out clause for parents who object to the vaccine for health, religious, moral or ethical reasons, she says parents who refuse immunization are harassed. "Your name goes on a state list. You get harassing calls from the CDC for your views on vaccines. Some families get thrown off health insurance plans, thrown out of their pediatricians' offices, thrown out of public schools--or parents are put in a room and grilled by officials about the depth of their religious convictions on this."
Finally, the backdrop to all these conversations is one unfurled by women's health advocates, who insist that we set the current action in a historical context. Walking around with the DES-Thalidomide-Dalkon Shield pharmaceutical disasters in the back of their minds, some worry that Merck's profit-driven rush to mandate this drug may prove problematic. "There's merit to questioning industry's motives in this case," says Heather Boonstra, public policy analyst at the Alan Guttmacher Institute, a nonprofit organization focused on sexual health research and analysis. "Because Merck itself has pushed so hard to make the vaccine mandatory, there's a bit of skepticism about industry's motives."