The only vaccine approved to target human papillomavirus is under fire as reports surface of serious side effects and even death among young women who received it.
The Food and Drug Administration approved Gardasil in 2006 for girls and women age 9 to 26. The vaccine is administered in three doses, and targets several strains of HPV that can cause cervical cancer.
Manufacturer Merck & Co. last month added fatigue, weakness and muscle pain to the list of possible adverse reactions to Gardasil, but families like the Davisons, who live in Frederick, don't believe the warnings are enough.
Mary Davison said her mother had cervical cancer, and she wanted to protect her three daughters from the same fate. Katherine Davison, 20, and her two younger sisters received their first Gardasil shots in November 2007, and their second in January.
None of the girls experienced any immediate side effects, but on Feb. 1, her 20th birthday, Katherine began feeling dizzy and developed flu-like symptoms.
The next day, her family doctor assumed she had the flu and gave her a phenergan shot to stop her vomiting.
The following day, Katherine lost feeling in the left side of her body. Her left eye was drooping and her pupils were unevenly dilated, and the dizziness persisted. Her parents took her to Frederick Memorial Hospital for a series of CT scans, which helped determine the problem: Katherine had had a stroke.
Neither doctors at FMH or Johns Hopkins could determine what had caused the stroke. They suspected Katherine's other medicines: she was on thyroid medication, as well as a birth control pill.
While the latter increases the risk of developing blood clots in women older than 35 and those who smoke, neither describes Katherine, and she had no previous problems with either medication. Merck doesn't list blood clots as a risk with Gardasil, and doesn't warn of adverse reactions with other drugs.
Eighteen deaths of women who received the vaccine have been reported since Gardasil's approval, and blood clots were responsible for four of these, according to a report released last month by Judicial Watch, a nonprofit conservative government watchdog group.
The report also found 140 reported serious adverse reactions, including seizures and trouble breathing. None have been determined to be a direct result of the vaccine, but the Davisons said they're distressed that the possibility of a connection has been so easily dismissed.
Merck officials maintain that the vaccine is safe.
"Before the shot I was fine, and there is no reason I should have had a stroke," Katherine said.
The family said doctors should be more informed about Gardasil and its side effects. Katherine said that of the 10 doctors she saw in the months following her stroke, only one knew anything about Gardasil.
"They should at least admit the possibility of these problems, and let doctors know they have these reports so they can track the side effects," said Doug Davison. "You can dismiss some of the reports, and say, 'It was this, and it was that,' but can you dismiss them all?"
While the lingering effects of her stroke aren't visible, Katherine said she still can't sense pain or temperature on her left side. She sometimes feels dizzy and tires easily, and she takes seven medications every day.
Doctors want to add Lipitor to that list since they can't determine the cause of her stroke and they want to see her cholesterol level drop from 101 to 80, just to be safe.
Mary Davison said her family doctor told her not to bring her younger two daughters in for their third shot. While the Davisons haven't hired a lawyer and aren't interested in a lawsuit, they do want the FDA to further examine Gardasil's effects.
"Who's checking? It seems like no one's checking," Doug Davison said.