After witnessing her daughter's widespread suffering, a mother works to spread the word about the potential dangers of Gardasil.
NORTH WILKESBORO --
At night, in the family's basement den, Rosemary Mathis would softly slip in bed beside her sleeping daughter, listening for breath, watching her chest move up and down.
"I was honestly afraid," Mathis said, "that she was going to die in her sleep."
Mathis kept that routine for more than a year as Lauren, her once sunny and energetic 13-year-old daughter, struggled with severe stomach pains, headaches, fever, depression and dementia, causing her to miss most of her eighth-grade year at North Wilkes Middle School.
Mathis felt certain that Lauren's undiagnosed illness could be traced to Gardasil, a vaccine used to prevent genital warts and cervical cancer caused by certain strains of the human papillomavirus or HPV, a virus passed on through sexual contact.
During those long nights, as Lauren slept, Mathis immersed herself in prayer.
"I promised God that I would help others if He would take care of her," she said.
More than two years later, with Lauren slowly regaining her health, Mathis remains committed to her end of the promise, transforming herself into an activist who is devoted to spreading the word about a vaccine that she believes endangered her daughter and other young women.
She can't and won't give specific medical advice, but her goal is to simply inform others of what happened to her daughter, confirmed by two doctors as being one of the rare people who are seemingly hurt, instead of helped, by a vaccine. Her two websites are www.truthaboutgardasil.org and www.sanevax.org. Gardasil, which is manufactured by Merck pharmaceuticals, was approved for use by the U.S. Food and Drug Administration in 2006 to prevent HPV infection, specifically some of the types that cause genital warts and cervical cancer.
Jennifer Allen Woodruff, a spokeswoman for Merck, said her company is "confident in the safety profile of Gardasil."
"There are health organizations throughout the world that have reviewed safety information about Gardasil and continue to recommend its use," she said.
HPV hits nearly half
About half of all people who are sexually active will acquire HPV at some point in their lives, making it the most common sexually transmitted infection, said Dr. Laura Bachmann, an infectious-disease specialist at Wake Forest University Baptist Medical Center.
Most people don't know they are infected because there are no signs or symptoms. In 90 percent of the cases, the body's immune system typically clears the virus on its own.
"For reasons we don't understand, some infections are persistent, and persistent infection is the key to developing these complications, and by that I mean cancer," Bachmann said.
Some women may develop precancerous lesions, which eventually lead to cervical cancer. Of the 12,000 new cases of cervical cancer each year, more than 10,000 are related to HPV, according to the Centers for Disease Control and Prevention.
Gardasil was developed to protect the body from four of the 100 different types of HPV — two that cause genital warts and two that lead to cervical cancer.
Bachmann sees Gardasil and Cervarix, another recently developed vaccine, as important tools in the battle against cervical cancer, which claims more than 4,000 women each year.
While regular pap smears have drastically reduced the number of cervical cancer deaths, no diagnostic test is perfect, she said. Pap smears also don't detect some of the other cancers, such as vulvar and vaginal, that may develop from HPV.
Upon Gardasil's approval by the FDA, the CDC's immunization advisory council recommended routine vaccination of girls as young as 9. The vaccine is most effective in girls before they become sexually active.
It was tested on 29,000 males and females in clinical trials around the world before it was approved, according to the CDC.
'I'm not anti-vaccine'
Mathis, a wife, mother of two and finance manager for Lowe's Home Improvement, was unfamiliar with Gardasil when she took Lauren to the doctor one day in February 2008 for a routine checkup.
Lauren, a seventh-grader at the time, was enrolled in classes for the academically gifted and enjoyed playing piano in church and for her friends.
Her doctor talked to Mathis about Gardasil, describing it as a series of three shots — spread over about six months — that may cause redness at the site of injection.
"I've always been for vaccinations. I'm not anti-vaccine at all," Mathis said. "The kids always had their vaccines."
She decided that Lauren should have this vaccination as well.
Two weeks later, Lauren complained of stomach pains and body aches and missed about two weeks of school.
Doctors said she had flu.
In April 2008, Lauren got her second shot.
Two weeks later, she was sick again with severe stomach pains and nausea.
Mathis asked the doctor about the vaccination. She was told Lauren had picked up a virus, a diagnosis that seemed plausible to Mathis.
Again, Lauren recovered after a few weeks.
A few months later, weeks before the start of eighth grade, Lauren had her third and final shot.
"It put her flat on her back," Mathis recalled. "By then, I knew what it had to be."
Stomach pain, diarrhea, cramps, depression and panic attacks left her bedridden. School was out of the question.
"I hit a state of depression," Lauren said. "I tried to go to school and just couldn't. I was scared and mad about it. All the doctors felt like I was making it up."
In between work and taking care of Lauren, Mathis connected with an online support group for mothers whose daughters became ill after getting the shots.
Their stories terrified Mathis.
"We would talk to each other and figure out what to do. A lot of them had the same symptoms of Lauren," Mathis said. "And then their child would die. I was honestly scared to death."
Vaccine injury confirmed
She scoured the Internet for information late into the night, worked from her home, tried to keep Lauren up-to-date on her schoolwork and took her to various specialists at Brenner Children's Hospital at Wake Forest Baptist Medical Center, some of whom told her they suspected she was injured by the vaccine.
A doctor at Duke University Medical Center also confirmed that Lauren was "vaccine injured."
In February 2009, a year after her first shot, Lauren began to recover, with the help of antibiotics and high doses of vitamins, her mother said.
Rather than resume her previous life, Mathis plunged into her role as activist. Using a math acumen that serves her well in her job at Lowe's, she compiled charts and graphs using numbers provided by the CDC to illustrate what she believes is a high rate of adverse events that follow Gardasil shots.
"This is the kind of work I do all day," Mathis said. "The other mothers I would meet really couldn't do this, and I had the ability. I believe that God gives you talent for some reason, and I have the talents to help others, and that's what I'm trying to do."
With help from Marian Greene, a Boone woman whose daughter also became ill after taking Gardasil, she started the website www.truthaboutgardasil.org, which serves as a site for people to share their stories about the vaccine. Mathis also started www.sanevax.org, a nonprofit organization that focuses on educating people about vaccines.
Mathis has also met with FDA officials and recently participated in a documentary about the drug that was financed in part by people who claim Gardasil injured a loved one.
The documentary, "One More Girl," is being produced by Ryan and David Richardson of Hawaii. They became interested in the subject after their sister suffered from fatigue and nausea for a year after getting one shot of Gardasil.
Mathis, who spends about 15 hours a week on issues related to the vaccine, said her work as a crusader is out of character. A devout member of Bethany Baptist Church and a Sunday-school teacher, Mathis called herself a strict mother who always tried to do the right thing for her kids. She urges parents not to rely just on their doctors for vaccine information.
Seeking independent data
Bachmann encourages parents to educate themselves, too. And she believes that if parents look at independent data, they will see that Gardasil is a safe vaccine that can prevent warts and several types of cancers and help patients avoid procedures that may result from abnormal pap smears.
She pointed to data from the CDC that indicate 35 million doses of Gardasil had been distributed in the U.S. by June 22, with 18,000 adverse effects reported, 92 percent of which were labeled "non-serious events," such as fainting and headaches.
There have also been 68 reports of death after a Gardasil shot, according to the CDC's Vaccine Adverse Events Reporting System, commonly known as VAERS. Thirty-two of the deaths have been confirmed and 36 are unconfirmed because of lack of patient information provided to the reporting system.
The CDC and Bachmann caution that the deaths shouldn't automatically be linked with Gardasil. Of the 32 deaths, there wasn't a pattern to suggest they were caused by the vaccine, according to the CDC.
"It's very difficult when you hear about bad things, but if you were to objectively look at the data right now, there is nothing that is creating a flag," Bachmann said.
Still, Mathis believes that the wider the information swath about Gardasil, the better.
"I'd like to see parents research vaccines before they get them and not go in blindly like I did," she said.