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Gardasil vaccine: Don’t let the headlines fool you

Consumer Reports News: July 28, 2008 11:45 AM

Each time a new vaccine is released a flurry of stories soon follows, featuring tragically ill patients and implying a cause-and-effect relationship between the vaccine and the illness. This time media attention is focused on Gardasil, the vaccine that prevents sexually transmitted infections for four strains of human papillomavirus (HPV) that cause roughly 70 percent of cervical cancers and 90 percent of genital warts. Since the vaccine was approved in 2006 for females ages 9 to 26, there have been more than 26 million doses given worldwide and nearly 16 million of those distributed in the U.S. Today the news media are focusing on adverse events, including 31 reported cases of Guillain-Barré syndrome (GBS) collected by the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System (VAERS) between June 2006 and April 2008. As a neurologist, I am well aware of how devastating this usually transient paralytic illness can be, but I was nevertheless outraged when I read careless headlines earlier this month, including: "Is HPV Vaccine to Blame for a Teen’s Paralysis?" and "HPV Vaccine Linked to Teen’s Paralysis?"

"In general, when it comes to vaccine-related illnesses, it's important to distinguish among observations that are true, true and unrelated, and events that are causally linked," says Kenneth C. Gorson, M.D., a neuromuscular specialist and professor of neurology at Tufts University School of Medicine. "In order to investigate whether the vaccine is in fact related to GBS, there needs to be a careful epidemiological study assessing the prevalence of GBS in a cohort of the population who has been vaccinated compared to a matched, unvaccinated control group." He also says that GBS cases have to be verified (only 10 of the 31 have been confirmed by the CDC), and that the illness must occur within six weeks of vaccination to be considered vaccine-related.

Gorson also points out that the natural incidence of GBS in the general population is 1 to 2 in 100,000 people. With nearly 16 million doses distributed in the U.S., at least 160 cases of GBS in the U.S. would have been anticipated in this population, unrelated to the vaccination—far more than the 31 cases that were actually reported, even if all were eventually verified. Of course, VAERS collects only unverified reports, and recent headlines such as the aforementioned may encourage such reports.

In both cases, they describe the tragic story of Jenny Tetlock, who received her third Gardasil injection in March of 2007. She first developed weakness in her legs in the spring of 2007 and is now almost completely paralyzed. Her father, Philip Tetlock, a psychology professor in the business school at the University of California-Berkeley, has set up a Web site to seek out and identify any "strong comparables" to Jenny’s case that may represent juvenile-onset Amyotrophic Lateral Sclerosis (ALS), the neurodegenerative disease also known as Lou Gehrig’s disease, which is distinct from GBS.

But even Jenny's father makes clear that he does not want his daughter to become the poster child for the anti-Gardasil campaign. He cautions that it is by no means certain that Gardasil caused Jenny’s illness, and that there is no medical consensus on whether that hypothesis is stronger than other possible explanations. And he’s right.

“In the face of an unclear adverse event risk, we have to be careful not to confuse causality with temporality,” cautions Gregory A. Poland, M.D., director of the Mayo Vaccine Research Group. “Each time there’s a report, as vaccinologists we have to take it seriously,” he said, explaining that it’s a signal to re-review the science and set up mechanisms to study the reports in a focused manner.

Consumer Reports recommends seeking information from reliable sources such as the CDC, the National Network for Immunization Information, the Immunization Action Coalition, and the Vaccine Education Center. Be aware that some groups with impressive-sounding names, such as the National Vaccine Information Center and Parents Requesting Open Vaccine Education, are actually anti-vaccine networks. The CDC recommends that the HPV vaccine series be administered to females at age 11 to 18. And Poland agrees. He’s more concerned about the potential harm that may be inflicted by not giving the vaccine, given a woman’s 50 percent lifetime risk of contracting HPV. Lessons can be also learned from prior misguided safety concerns about the Hepatitis B, measles and pertussis vaccines. In fact, he has advised his own college-aged daughter to continue her three-shot series of Gardasil vaccinations.

Orly Avitzur, M.D., board-certified neurologist and medical adviser to Consumers Union

Read more on Gardasil, find out which girls and women should not get the vaccine, and learn more about the controversy surrounding the vaccine.

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