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|Wed, 12-10-2008 - 11:47am|
Mom, Others Question Gardasil's Safety
Deaths Reported After Vaccine Administered Worry Some
updated 5:15 p.m. ET, Tues., Nov. 25, 2008
BALTIMORE - It's been hailed as a public health breakthrough, but a vaccine intended to prevent a type of cancer in young women still has some people questioning its safety.
Emily Tarsell's Web Site: http://www.gardasilandunexplaineddeaths.com/
The Gardasil vaccine has been given to millions of girls and young women, and assurances have been made that it is safe. But WBAL TV 11 News I-Team lead investigative reporter Jayne Miller spoke with a mother whose daughter died only a few weeks after receiving the shot.
Emily Tarsell has several paintings done by her daughter, Chris, hanging throughout her Baltimore County home. Chris Tarsell was a talented and aspiring artist, but she suddenly and inexplicably died in June at the age of 21.
"No one heard from her," Tarsell said. "They went into her bedroom and found her in the bed, dead."
Tarsell said she learned of her daughter's death when police officers knocked on her door.
"It was about, I don't know, maybe eight o'clock. I was alone, and then they told me," she said.
During an autopsy, a pathologist searched for the cause of Chris's death, but found none. Her final report listed cardiac arrest, cause undetermined, Miller reported.
"They could not find anything. All the tests came back negative, so it's still unknown," Tarsell said.
Weeks later, a family member mentioned to Tarsell news reports about Gardasil.
"My sister and I were stunned," Tarsell said.
The reports in July raised questions about the safety of the vaccine that is intended to prevent four strains of the human papillomavirus, or HPV, that's linked to cervical cancer. It was approved two and a half years ago for girls and young women ages 9 to 26.
Tarsell said she recalled that her daughter had received her third Gardasil shot less than three weeks before her death. She also remembered that Chris had complained of not feeling well right after the shot.
"She said, 'I feel dizzy when I stand up, mom.' And she said she was tired," Tarsell said.
Chris Tarsell's death has been reported to federal authorities to a system called the Vaccine Adverse Event Reporting System, or VAERS, that's maintained by the Centers for Disease Control and Prevention and the Food and Drug Administration.
At last report on Aug. 31, VAERS had received reports of 27 deaths among girls or women who had been injected with Gardasil. In addition to Chris, they included Jessica Erickzon, of New York, who was 17 when she died of an undetermined cause less than 40 hours after the Gardasil shot was administered. But a link to Gardasil has not been made in any of the cases.
"They're tragic, but they don't appear to be causal," said Dr. Kevin Ault, a clinical researcher of Gardasil at the Emory University School of Medicine.
Ault said he was involved in the latest study of possible Gardasil side effects last month. The study looked specifically at reports that included the neurological disorder Guillain-Barre syndrome, fainting and seizures. It concluded Gardasil posed no increased risk.
"What they found was that the rare adverse events that you may have heard about in the news don't seem to be any more common in the people who got the vaccine than the people who didn't get the vaccine," he said.
"It's basically written off as a coincidence -- not connected," said Barbara Loe Fisher, a safety watchdog for the National Vaccine Information Center.
She said she is critical of the CDC, FDA and Gardasil in particular, arguing the vaccine was put on the market too fast.
"You cannot have the same people who are regulating, making policy for and promoting mass use of vaccines also in charge of making sure they're safe," Fisher said.
She said a big shortcoming is the VAERS reporting system.
"It's a very passive, voluntary system," she said.
"There are many limitations to VAERS," said Dr. Neal Halsey, who heads the Institute for Vaccine Safety at the Johns Hopkins University School of Public Health. "Because it's a passive system, not all cases get reported. We also often don't have the total numbers of people who get the vaccine at one time, so you can't determine what the rate is."
Chris Tarsell's death raised another question about the VAERS system -- what is done to investigate when a report of a serious adverse event is filed?
"Since the time that you reported to that system, have you heard anything from anybody at the FDA, CDC, or any federal agency?" Miller asked Emily Tarsell. She responded, "No."
"Should someone be calling, saying we need to know more? I think that's a fair question," Halsey said. "Maybe these parents are telling us they want to be contacted. That's not a bad idea. It is not a part of the system at this time, but it doesn't mean there isn't concern."
Underlining the concern in Chris's case is what Gardasil's manufacturer, Merck, indicated to Chris's doctor, Miller reported. In a letter acknowledging the doctor's report of her death, Merck listed a viral infection as a factor in the case, but there is no indication Chris suffered from any such infection.
"If that's part of what determines their investigation into things, you'd think they'd want to get it right," Emily Tarsell said.
Merck officials told the I-Team that what appears in that letter is what was initially reported to the company. They wouldn't comment on whether they believe a viral infection is still a factor in Chris's case, citing the HIPPA privacy law, Miller reported.
About 30 million doses of Gardasil have currently been given. Merck has backed off its earlier campaign to get states to make the vaccine mandatory.
A recent article in a medical ethics journal argued against requiring the vaccine, saying, "The long-term safety and effectiveness of the vaccine are unclear, and serious adverse events that have been reported raise questions about its short-term safety, as well."
"She loved texture, and color and light," Emily Tarsell said of her daughter.
She has created a Web site about her daughter's death, hoping to connect with others to share information.
"I realize there are other families, like our family, who want to find answers," she said.
Chris Tarsell would have turned 22 earlier this month.
By the end of the year, Merck said it intends to seek approval for Gardasil's use by boys to prevent genital warts, Miller reported.
For links to the VAERS Web site, click on the link above.