Gardasil Under Fire
A vaccine designed to prevent cervical cancer is coming under fresh scrutiny amid thousands of complaints linking it to a range of health problems.
Gardasil has been the subject of 7,802 "adverse event" reports from the time the Food and Drug Administration approved its use two years ago to April, according to the Centers for Disease Control and Prevention.
Girls and women have blamed the vaccine for causing ailments from nausea to paralysis -- even death. Fifteen deaths were reported to the FDA, and 10 were confirmed, but the CDC says none of the 10 were linked to the vaccine.
The CDC says it continues to study the reports of illness.
Gardasil prevents the spread of human papillomavirus, known as HPV -- a sexually transmitted virus that can cause cervical cancer in a relatively small number of girls and women.
The vaccine's manufacturer, Merck & Co. Inc., says it has distributed more than 26 million Gardasil vaccines worldwide, including nearly 16 million in the United States. It estimates that eight million girls and women have received the vaccine in the United States since June 2006.
Two girls allege in court that the vaccine made them sick.
One -- Jesalee Parsons of Broken Bow, Oklahoma -- got the shot at age 13.
Jesalee's lawyer, Michael McLaren, said Jesalee got the shot on Feb. 27, 2007 and soon developed a fever and felt pain. The next day, he said, she felt pain in her chest and abdomen.
Her mother, Laura Parsons, said Jesalee spent weeks in the hospital and underwent two surgeries after developing pancreatitis. She says the federal government should have studied the drug more before approving its use.
"I just feel let down by the government," she said.
Merck says it could be a coincidence that the girls got sick after receiving the vaccine.
The company said in a statement that an adverse "event report does not mean that a causal relationship between an event and vaccination has been established -- just that the event occurred after vaccination."
Merck said it would continue to evaluate reports of adverse reactions. It said it "updates product labels with new safety information as appropriate."