Mother: vaccine caused death
Five months after coming home to find her teenage daughter dead in the bathroom, Lisa Schryver Ericzon of the town of Orleans told the New York Post she blamed the unexplained death on the vaccine Gardasil.
Jessica F. Ericzon, 17, was a "guinea pig" for Gardasil, Mrs. Ericzon is quoted as saying in the Post this week.
Asked about Gardasil on Wednesday, health officials said the vaccine was safe and should continue to be administered to women ages 9 to 26. The vaccine is the first known preventive against the human papillomavirus, which can cause cervical cancer.
"So far the evidence we have points against Gardasil causing deaths in young teenagers," said Dr. Jana Shaw, pediatric infectious disease specialist and medical director of the North Country Children's Clinic, Arsenal Street, which administers the vaccine.
Dr. Shaw was not involved with Ms. Ericzon's care. But like other health experts, she was skeptical about blaming the Gardasil vaccine for the young woman's death.
"We don't even know what she died of," Dr. Shaw said. "You could blame a toothbrush."
Ms. Ericzon, a senior at LaFargeville Central School, received the first of her three Gardasil doses in July 2007 and the last on Feb. 20, two days before she died.
Speaking to the New York Post, Mrs. Ericzon said her daughter had complained of pain in the back of her head, fatigue and soreness in her joints following the injections.
Mrs. Ericzon could not be reached for comment.
Jefferson County Medical Examiner Dr. Samuel A. Livingstone performed an autopsy Feb. 23, a day after Ms. Ericzon's death, but did not find a cause of death. Toxicology reports were similarly inconclusive.
After the autopsy, Dr. Livingstone reported the death to the federal Vaccine Adverse Events Reporting System, or VAERS.
The Food and Drug Administration and Centers for Disease Control and Prevention use the system, which accepts reports from patients and doctors alike, as a means of looking for patterns in possible vaccine side effects.
Curtis L. Allen, a spokesman for the CDC, said such reports should not be taken as proof that the vaccine is responsible for an individual case.
"It's not quite as cut and dried as many people would think it would be," he said. "VAERS is an early warning system — what it does is, it points you towards dangerous signals. It doesn't say, 'OK, this is a cause.'"
Merck & Co., which introduced the Gardasil vaccine in June 2006, has distributed more than 26 million doses, with nearly 16 million in the United States, according to the company Web site.
In a July 8 statement, the company said it had looked into reports of death and paralysis following vaccinations and "believes that no safety issue related to the vaccine has been identified."
"These types of events are events that could also be seen in the general population, even in the absence of vaccination," the statement said.
As of June 30, VAERS had collected 9,749 reports of patients experiencing adverse effects after they received a dose of Gardasil. Mr. Allen said 94 percent of the reports, or just under 9,200, were classified as non-serious effects, such as fever, sore arms or fatigue.
Gardasil had a 6 percent rate of patients reporting serious adverse effects, including health issues that required hospitalization or were potentially life-threatening.
That's much lower than the typical rate for vaccines, Mr. Allen said, adding that most have a 10 percent to 15 percent rate of reported serious adverse effects.
As of April 30, VAERS had collected reports of 18 deaths following a dose of Gardasil.
Seven of the reports had no supporting information that a person had died, such as an autopsy or death certificate, Mr. Allen said. Three reports are still under review.
Among the remaining eight reports were one case of suicide, one drug overdose, two influenza-related deaths, a death related to diabetes and two cases of thrombosis, or blood clots. The last two women had been on birth control, for which blood clots are a potential side effect, Mr. Allen said.
"There was not a common pattern to the deaths that suggested they were caused by the vaccine," he said.
Jefferson County Public Health Services, Watertown, began offering the vaccine last April. Since then, 1,052 doses have been administered, said Stephen A. Jennings, Jefferson County public health information officer. The county has not filed a single VAERS report as a result of those vaccinations.
"We've received no confirmation of Gardasil-linked deaths in our county, ever," he said. "To our knowledge, there aren't any in the nation."
Mr. Jennings said public health services would continue to offer the vaccine until CDC recommended otherwise.
Claire T. Pospisil, spokeswoman for the state Department of Health, called the death of Ms. Ericzon a "tragedy." But she said the state also stands by Gardasil as a safe and effective way to prevent HPV-related cervical cancer.
Ms. Pospisil pointed to CDC figures that 12,000 women will be diagnosed with cervical cancer this year and that a third, or about 4,000, will die of the disease.
"I'd like to stress the public health benefit that is evident," she said. "The vaccine has a potential benefit to improve the health of millions of girls and women."
