Questions surrounding vaccine safety are nothing new. "Vaccine safety is a very complicated issue. … Parents are very concerned about it," Allen says. In 1988, the federal Vaccine Injury Compensation Program (VICP) grew out of vaccine makers' response to a number of substantial awards for vaccine-related injuries.
In anticipation of the financial ramifications, most vaccine makers threatened to cease production, putting the vaccine supply in real jeopardy.
In response, Congress set up a no-fault program which paid individuals with vaccine-related injuries but limited their ability to sue the vaccine manufacturers. The VICP has paid out injury compensation claims on almost 20 different vaccines. Gardasil was added to the list in February 2007.
Since its inception, VICP has paid out for more than 2,000 cases of vaccine-related injuries. An equal number have been filed and dismissed.
Kevin Conway, a Boston-based lawyer, has been representing patients since the inception of the National Vaccine Injury Compensation Program more than 20 years ago. In that time, he has represented hundreds of individuals injured by vaccines and currently represents eight families that are planning to file for Gardasil-related injuries.
He says the "legal standard' used to resolve disputes, and ultimately determine payouts, is very different than the scientific standard used to determine whether vaccines are safe.
"Most scientists would say there's no scientific evidence … but there's legal proof," he says. "Therein lies the controversy and the tension."
Despite dedicating himself to these patients, he supports the vaccination program. "Injuries are rare. … The vaccination program is like a social contract. Some small number of people have to suffer for the greater good."
The question, of course, remains: "How many vaccine injuries are too many?" Parents of injured children will almost certainly say that even one injured child is unacceptable. Public health officials, however, argue that the number of lives saved far outweigh the small risk associated with the vaccinations.
In fact, most medical experts would agree that vaccines have been one of the most successful public health programs of the 20th century. Smallpox, one of the most devastating diseases known to humanity, was eradicated in 1979, thanks to a worldwide WHO vaccination campaign. Polio, a debilitating disease that left previously healthy children in iron lungs, is a disease of the past in most developed countries.
Focus groups of parents conducted by the CDC reveal that parents still rely on their children's pediatricians for guidance on these complicated issues and see them as the most important messenger of safety of vaccines.
And physicians are finding that they are spending an increasing amount of time educating patients about vaccines.
As Dr. Racine, who frequently offers Gardasil to his female patients, puts it, "I would not give my own children a vaccine that I did not consider to be safe and effective. This is the best advice I can offer anyone."
Dr. Kendall Krause graduated from Yale School of Medicine and recently completed her internship at the Harvard Affiliated Emergency Medicine Residency in Boston.