About a month after being vaccinated against the cervical cancer-causing HPV virus, 13-year-old Jenny Tetlock missed the lowest hurdle in gym class, the first hint of the degenerative muscle disease that, 15 months later, has left the previously healthy teenager nearly completely paralyzed. Did the vaccine, Gardasil, cause her condition? Her father, Philip Tetlock, a psychology professor at UC-Berkeley's Haas School of Business, has embarked on an odyssey to find out whether the vaccine or random coincidence is to blame.
As father and scientist, Tetlock has contacted top medical experts, posted pleas on discussion boards looking for other teens who've experienced neurological problems post-vaccination and has been desperately trying to get the government to open an investigation into his daughter's case. "The weakening process is gradual so it may take months for parents to notice what is going on," he writes me in an E-mail. He started a blog a few weeks ago that shows photos of his sweet-faced teen and reveals his anger and frustration in the form of a box counting the days that he has yet to get a response from the government's Clinical Immunization Safety Assessment Network. As of today, it's 28.
He's not the only one to raise an alarm. The conservative public watchdog group Judicial Watch has been periodically obtaining adverse event reports on Gardasil from the Food and Drug Administration. I received the group's latest warning this week: of 10 deaths linked to Gardasil since September 2007 and 140 reports so far this year of serious effects such as miscarriage and Guillain-Barré syndrome, a nervous system disease that causes weakness and tingling in the arms and legs. (But these reports filed by patients or doctors with the government's vaccine adverse event reporting system may or may not reflect true vaccine risks. Some problems may be missed or underreported, while others, including sudden deaths, may have nothing to do with the vaccine itself.)
Judicial Watch opposes efforts in many states to make the vaccine mandatory for all girls ages 11 and 12. Those efforts have raised concerns among religious groups that protecting against the sexually transmitted virus will encourage promiscuity among teen girls. The FDA insists there's no medical reason to be worried. "We're monitoring the safety of the HPV vaccine very carefully, and the only adverse event that causes some concern is syncope or fainting after the vaccine," says Robert Ball, director of the FDA's office of biostatistics and division of epidemiology at the center for biologics evaluation and research. Higher rates of Guillain-Barré have been associated with the swine flu vaccine and possibly with the meningitis vaccine Menactra, but it is no more common in those who get Gardasil than in those who don't, says Ball. The same goes for other side effects like spontaneous miscarriage.
What's more, the FDA has not documented any other cases of vaccine-related peripheral motor neuropathy—what Jenny has—either in the adverse event reports filed by doctors and patients or in the manufacturer's clinical trial data. Merck, the vaccine's manufacturer, has dismissed the possibility that Jenny's condition was caused by Gardasil. "We're aware of this case and based on the facts that we've received, the information doesn't suggest that this event was causally associated with vaccination," says Merck spokesperson Kelley Dougherty.
Tetlock, though, wonders if Jenny carries genes that predisposed her to problems with the Gardasil vaccine. At age 10, Jenny developed a rare skin disease called pityriasis lichenoides that's thought to be triggered by an overactive immune system, and her grandmother died of a nervous system disease. Could it be that certain genetic tendencies make some people more likely to develop severe reactions from vaccines? I ask Ball. "That's an important question," he responds. "We just don't know." It's certainly going to be a topic of future research, he adds. The Centers for Disease Control and Prevention is starting to look at whether those who developed Guillain-Barré after being vaccinated share a common set of genes. So Tetlock could find out someday if his hunches are correct.
At this moment, he and his wife, Barbara Mellers, also a professor at Berkeley, are focused on being with their daughter as she struggles to breathe on her own. "Jenny endures terrible suffering each day," Tetlock tells me via E-mail. "She must watch her capacity to control her own body gradually ebb away—and each day her hopes of ever having a normal human life recede ever further into memory. The disease is cruel beyond belief."
As a parent, I've wrestled with whether or when to get my 12-year-old daughter vaccinated against HPV. As much as vaccines are vital in protecting against life-threatening infectious diseases, they do, indeed, have the potential to cause harm—however rare that may be. Evidence is mounting that the mercury-based vaccine preservative thimerosal could trigger autism in certain susceptible kids, as my colleague Bernadine Healy previously reported. We don't know yet whether Jenny's illness is linked to Gardasil, though it's certainly plausible given the timing of symptoms several weeks after vaccination, which is when vaccine-related neurological problems typically occur. I'm not sure whether Jenny's case has changed my opinion about the value of Gardasil. But it certainly has given me pause.