Doctors Come Out in Support of Cervical Cancer Vaccine

July 14, 2008— -- It's a rite of passage, the stuff of Norman Rockwell paintings. From birth through old age, we stoically endure the jabs of needles meant to ward off disease of one kind or another. Yet vaccines occupy a tenuous position in many Americans' psyches.

Two years after its introduction, the so-called "cervical cancer" vaccine, Gardasil, has found itself squarely in the crosshairs. Previously healthy girls, playing soccer and going to prom, are suddenly falling ill, struck by incomprehensibly tragic diseases. Many are paralyzed, a number of them have died.

What is happening to these girls? And, people want to know, what is to blame?

Many of them had recently received Gardasil, a vaccine against HPV (human papilloma virus), a sexually transmitted virus that is largely responsible for 11,000 cases of cervical cancer resulting in 3,600 deaths a year.

Still, leading pediatricians and vaccine safety experts overwhelmingly say they will continue to recommend the vaccination to patients — even to their own daughters.

Dr. Kevin Ault, who has been involved in HPV vaccine research for more than a decade and has authored several articles about the topic, is arranging for his daughter to get the vaccine in a few weeks. He says he is reassured by what he knows from the first 13 million doses, stating "the vaccine is safe."

Dr. Andrew Racine oversees two large academic practices with more than 50,000 visits per year and says he routinely offers Gardasil to all his adolescent female patients; he has not seen any adverse events, apart from pain at the injection site. He also has made sure that both of his teenage daughters have been immunized.

And Dr. Charles Shubin, a practicing pediatrician for almost 40 years, has given Gardasil to more than 1,000 of his patients,and has experienced no negative reactions from patients at all, "not even minor complaints."

Though the practitioners and researchers we interviewed aren't currently expressing concerns about the safety profile of Gardasil, they did stress the importance of continuing to closely monitor the vaccine's safety.

Following FDA approval, vaccines are subject to an ongoing adverse event monitoring system. Dr. Leo Twiggs, Chair of Obstetrics and Gynecology at the University of Miami, notes, "The system which evaluates vaccine safety is well constructed to look out for public safety."

Doctors state they will be looking to recommendations coming from the FDA and CDC, in addition to peer reviewed journals for guidance. Dr. Donna Shoupe a professor of Obstetrics and Gynecology at the University of Southern California, says, "What they say will have tremendous influence and they need to get this one right."

Vaccine-Related Events: As Bad as They Seem?

Since the U.S. Food and Drug Administration approved the HPV vaccine two years ago, doctors have given more than 16 million doses of the vaccine to approximately eight million girls.

In that same time period, more than 8,000 vaccine-related events have been reported via the Vaccine Adverse Events Reporting System, a safety surveillance program that is coordinated by the FDA and U.S. Centers for Disease Control and Prevention. The system was designed to collect information about possible side effects (also called "adverse events") that occur following immunization with licensed vaccines.

Although, at first glance, the numbers are startling, parents may be able to breathe a sigh of relief. Curtis Allen of the CDC says that almost 95 percent of the events are minor reactions, such as sore arms. Of the events reported, only 7 percent have been classified as "serious." To put this in perspective, Allen says that most vaccines have a 10 to 15 percent serious report rate.

The reports have included 10 confirmed cases of a paralytic syndrome called Guillain-Barre Syndrome (GBS), which is associated with certain types of infections. Half of the cases were in girls who also received the meningitis vaccine Menactra, which has been associated with a slightly increased incidence of the syndrome.

The important fact to note here is that, even in an unvaccinated population, the expected rate of GBS (approximately one to two out of every 100,000 teens) would result in about 40 cases per year. Therefore, the rate we are seeing reported in girls who have been given Gardasil is actually lower than would be expected by pure chance.

Furthermore, reports don't indicate a proven association or cause-and-effect situation. "A report is a good thing," Allen says. "The more reports there are, the more likely we are to determine whether there is a cause and effect from the vaccine."

Twiggs writes, "Unfortunately, the self-reporting of vaccine side effects has lead to a perception that the vaccine is not safe, which is truly incorrect."

Furthermore, many experts such as Dr. James King, head of pediatrics at the University of Maryland, point out that, as any vaccine given to large numbers of individuals, there is a "predictable flurry of associations" and opportunity for coincidental events.

According to Mark Slifka, of the Vaccine and Gene Therapy Institute, other undiagnosed infections could have occurred at the about the same time as the girls' vaccinations. For example, he says that there were likely more than 700,000 cases of undiagnosed cases of West Nile virus in 2003 alone.

A coincidental, unrelated infection contracted around the same time as a HPV vaccination could explain cases, he says. He also points to coxsackievirus, another everyday virus that can cause inflammation of the heart and "sudden death" (such as the cases reported in conjunction with Gardasil) in otherwise healthy people.

According to the CDC's Allen, "The bottom line here is that HPV is very pervasive. By the time a woman is 50, there is an 80 percent chance she will have had HPV. The vaccine protects against strains responsible for 70 percent of cervical cancer that cause 3,600 deaths a year. It is a safe and effective vaccine."

The FDA concurs, stating that "we continue to think that Gardasil is safe and effective."

According to the CDC's Allen, "The bottom line here is that HPV is very pervasive. By the time a woman is 50, there is an 80 percent chance she will have had HPV. The vaccine protects against strains responsible for 70 percent of cervical cancer that cause 3,600 deaths a year. It is a safe and effective vaccine."

The FDA concurs, stating that "we continue to think that Gardasil is safe and effective."

Vaccine Safety Is a Complex Issue

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."

Drawing the Line

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.