Chronically ill girl eyes vaccine
Despite reports, maker, agencies defend Gardasil
By Judi Villa, Rocky Mountain News
Published February 2, 2009 at 12:05 a.m.
Ashley Ryburn, 16, sits with her mother, Lisa Holtman, at their home in Arvada. Until a year ago, Ashley was an active, healthy teenager. Since receiving the Gardasil vaccine to prevent cervical cancer, however, Ashley has suffered seizures, headaches, nausea, dizziness and paralysis.
Ashley, 16, played four sports, danced in her high school's show choir and earned top grades without even trying.
But now, Ashley was exhausted all the time. She was nauseated. She passed out at show choir and blacked out at school.
And then one day Ashley's legs went numb. She couldn't walk.
"You see somebody touch your legs and you can't feel it," Ashley recalled. "That's the scariest thing in the world."
For a year this has gone on: four episodes of temporary paralysis. Back spasms so painful Ashley would tell her mom "bye" and stop breathing. Hospitalizations. More 911 calls than Ashley can count. Trip after trip to doctors who couldn't seem to find anything wrong.
"I've heard so many times I'm crazy, I'm bulimic, I'm on drugs," Ashley said. "It's not your first thought that it's a vaccine."
A vaccine? Lisa Holtman is convinced that's what turned her perfectly healthy daughter into a chronically ill teenager.
In August and October 2007, Ashley was given doses of Gardasil, a vaccine recommended for adolescent girls to prevent cervical cancer. Her first Gardasil shot was given in conjunction with a meningitis vaccine.
The combination is said to be safe - and is commonly administered - but Gardasil was never clinically tested with the meningitis vaccine.
Research from the National Vaccine Information Center indicates reactions to Gardasil increase when it is given with the meningitis shot. But Neal Halsey, director of the Institute for Vaccine Safety at Johns Hopkins Bloomberg School of Public Health in Baltimore, said general guidelines allow for two or three inactivated vaccines, such as the HPV and meningitis vaccines, to be given at the same time without expecting increased rates of adverse reactions.
The meningitis vaccine was not available when Gardasil began clinical testing, so the Food and Drug Administration agreed to test it post-licensure, Halsey said.
Results of those tests are expected to be released soon.
"There is no reason that I know of that there may be an increased risk of any serious complications associated with the simultaneous administration of these two inactive or killed vaccines," Halsey said in a recent interview.
Ashley didn't receive any other shots with her second dose of Gardasil. It was a month or so after the second Gardasil vaccine that she started getting sick.
"She didn't go to the doctor at all, then after she got the shots, it's boom, boom, boom," Holtman said. "We haven't stopped."
Across the country, there are reports of girls like Ashley becoming chronically ill, and even dying, after being vaccinated with Gardasil - raising questions about whether the vaccine is indeed safe and if there has been enough testing done on its side effects.
Gardasil, manufactured by Merck and Co., was licensed in 2006 by the U.S. Food and Drug Administration. The Centers for Disease Control and Prevention and Merck both say the vaccination is safe. So does Dr. Judith Shlay, director of the immunization and travel clinic at Denver Health Medical Center.
Shlay says Denver Health administers thousands of vaccines each year, including Gardasil, and rarely has any problems. The biggest issue with Gardasil was reports of adolescent girls fainting, but Shlay said Denver Health devised a protocol that involved monitoring teens before they left and that has alleviated the concern.
"It's considered a very safe vaccine," Shlay said. "We haven't seen people get sick from it."
As of Aug. 31, the federal Vaccine Adverse Event Reporting System (VAERS) had logged 10,326 reports of reactions to Gardasil, according to the CDC. Of those reports, 94 percent were considered to be "nonserious."
The serious reports included Guillain-Barre syndrome, a rare disorder that causes muscle weakness, blood clots and death. Each incident was "carefully analyzed by medical experts," the CDC said in a report last updated in October.
"Experts have not found a common medical pattern to the reports of serious adverse events reported for Gardasil that would suggest that they were caused by the vaccine," the CDC said.
'No safety issue'
Merck issued its own statement in July, saying it was "proud of the public health benefit that Gardasil can provide in helping to prevent cervical cancer" and maintaining that "no safety issue related to the vaccine has been identified."
Still, in 2007 and 2008, Gardasil accounted for about 20 percent of reactions reported to VAERS, said Barbara Loe Fisher, co- founder and president of the National Vaccine Information Center, a watchdog group in Virginia.
Fisher calls the percentage "unusual" given that Gardasil is new and isn't mandated.
"This is a whitewash of this vaccine. To say that almost 10,000 reports of reactions, injuries, 30 deaths is all a coincidence is simply not scientifically responsible," Fisher said. "You have perfectly healthy girls go in and get this shot and then suffer a pattern, a very clear pattern of injury, and some of them are dying. This is not acceptable."
The side effects all look a lot like what's been happening to Ashley, Fisher said: brain inflammation, immune system dysfunction, tingling and numbness in the hands, feet and legs, severe headaches, strokes, joint pain, muscle weakness, seizures and memory loss.
"Usually, these girls are very high functioning," Fisher said. "They're honor roll students. They're athletes. They're usually in extremely good health before they have a severe downward turn after receiving one or more Gardasil vaccinations."
But Halsey, of the Institute for Vaccine Safety, said people need to be "very careful not to jump on the bandwagon" that vaccines caused illness. Such allegations have surfaced before only to be disproved in resulting studies.
Serious allergic reactions to the HPV vaccine are rare, about one in a million, putting them in "the same ballpark" as any other vaccine, Halsey said.
"The evidence does not support a causal relationship," he said. "It's much more likely to be coincidental."
Can't go back
Still, Ashley's life looks nothing like it did before Gardasil. Her days consist mostly of going to school, coming home and sleeping. Her hair falls out in clumps. Her nausea is ever present. Her blood pressure drops dangerously low. She can't breathe.
Ashley looks back on pictures of summer camp just before she received the first Gardasil shot. She is saddling horses, hoisting a counselor for fun and leg wrestling.
"It hurts to know that if I went back to that day in my health now, I couldn't do it," Ashley said. "I can't do those things anymore."
Ashley received her vaccinations in Iowa before she and her mother moved to Arvada. It was recommended during a routine physical. Since then, Ashley has had to quit sports and her grades have slipped from A's and B's to B's and C's. Most of the time, she can't remember what she's read from one day to the next.
When she tried out for basketball at her high school this year, her legs were shaking and she couldn't breathe after two drills. Ashley cried.
She takes a handful of pills every day and has to carry a special bag of medical supplies in case she has an "episode."
Even when Ashley has good days, she knows the twitches in her back and the funny feeling in the back of her head will always come back, signaling another episode. Her blood pressure will plummet. She will hear her mother or her boyfriend talking to her, but she won't be able to answer. She will have trouble breathing and she will pass out.
"If I had never got the shot, I would be a normal teenager," Ashley said. "I wish I could go back."
Genital human papillomavirus (HPV)
* Most common sexually transmitted virus in the United States
* At least half of sexually active people will have it at some point in their lives, accodring to CDC estimates. There often are no symptoms, and it usually goes away on its own without causing any serious health problems.
* Three shots over six months
* It protects against four strains of HPV, which are responsible for 70 percent of cervical cancers and 90 percent of genital warts. It is recommended for girls as young as 9.
* Several states, including Colorado, have introduced legislation mandating the vaccine for girls entering the sixth grade. Only Washington, D.C., and Virginia have passed the mandates, to take effect in 2009 and 2010, respectively.
* Colorado has had no reports of serious reactions to the vaccine, according to Joni Reynolds, immunization program director for the Colorado Department of Public Health and Environment.
* The Institute of Medicine is about to convene a two-year study of injuries and deaths related to four vaccines, including HPV.