WRAL Investigates

Questions surround safety of cervical cancer vaccine

Posted February 19, 2009 12:32 p.m. EST
Updated March 9, 2009 5:13 p.m. EDT

— In track and field, 17-year-old Holly Runstrom was one of the best high school athletes in the state. The mile, the 4 x 800 relay – she was a star.

"Track is my life," Runstrom said. "I love it. It's what I do."

Runstrom's life took a dramatic turn last May within days of taking Gardasil, a vaccine given to girls and women ages 9 to 26 to help protect against the virus that causes cervical cancer.

The Clyde teen says she was hospitalized with symptoms of dizziness, headaches, breathing difficulty, fatigue, stomach pains and chest pains, which she said felt like a knife had cut into her chest.

"Everything came back absolutely normal," said her mother, Marian Greene. "None of the tests were off. She felt awful, but there was no medical evidence – nothing pointing to what was wrong with her."

Two months after the symptoms started, doctors diagnosed Runstrom with mononucleosis.

Runstrom says that even today, she is still too weak to run or go to school.

"I don't have any strength," she said. "I get headaches constantly, and I never used to get headaches."

Her family thinks Gardasil is responsible. Doctors do not know if her condition is related to the vaccine or if it is a coincidence.

However, the U.S. Centers for Disease Control and Prevention, which monitors reports like Runstrom's, says there is no evidence that the vaccine causes any serious side-effects.

Of the 22 million women and girls in the United States who have received the vaccine, approximately 10,000 cases of adverse side-effects have been reported. Of those, 6 percent are considered serious.

The CDC reports there are side-effects, including fainting, pain and swelling at the injection site, headache, nausea and fever, but it has not found a common medical pattern to reports of serious adverse problems directly linked to the vaccine.

Hailed as a miracle breakthrough, Gardasil exploded on the U.S. market in 2006 as a way to help prevent infection from four types of human papillomavirus, two of which cause 70 percent of cervical cancer cases.

Doctors believe the vaccine, manufactured by pharmaceutical giant Merck & Co., will lower cervical cancer rates.

"You have to remember that 30 women a day are diagnosed with cervical cancer," said Dr. Nicole Parkerson, a Raleigh pediatrician who regularly administers the vaccine. "Ten a day die of cervical cancer. In my opinion, it's a huge benefit for girls this generation."

The National Vaccine Information Center, a vaccine watchdog group, is calling for more study of the vaccine and its side-effects.

The group says that compared with Menactra, a vaccine for meningitis, Gardasil is associated with at least twice as many emergency room visits, four times as many deaths, five times as many reports of not recovering and seven times as many reports of being disabled.

A CDC spokesman says the numbers are not a fair comparison of the two vaccines. Boys and girls both receive the meningitis vaccine. Gardasil involves three injections, which means more occurrences of side-effects.

The CDC had not issued a formal statement to WRAL News as of Thursday afternoon.

"NVIC is not a medical organization and has a long history of raising concerns about vaccines that are in direct conflict with the opinion of leading medical experts," Amy Rose, director of media relations at Merck, said in a statement to WRAL News.

Merck's Web site includes a statement referring to reports of serious side-effects. It says a reported case "does not necessarily mean that the vaccine caused or contributed" to the reported health problem.

Rose also says the company carefully monitors the safety of the vaccine.

"Nothing is more important to Merck than the safety of our products," she said. "Experts at the FDA and CDC also continue to review data, and as recently as four months ago, said 'Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks.'"

Meanwhile, as the debate over the vaccine and its safety continues, Runstrom and her mother say they are moving forward and trying to stay positive.

"Every day is a new battle," Greene said. "Every day is a blessing."

Runstrom says she wants to find out how she became ill, but more than anything, she wants to race again.

"I want to be better, so I can fulfill my dreams and my goals," she said. "And I want to be healthy again. Mainly, that's what my goal is."