Fred Lucas | Staff Writer | Friday, October 19, 2007
Federal officials and Gardasil's manufacturer, Merck Co., insist that none of the eight young women, ages 11 to 22 who reportedly died after the injection of the Human Papillomavirus vaccine, died because of the vaccine.
The Human Papillomavirus (HPV) is a sexually transmitted disease and is the leading cause of cervical cancer. The numbers on adverse reactions and deaths came from the Vaccine Adverse Event Reporting System (VAERS), a system run jointly by the Food and Drug Administration and the Centers for Disease Control and Prevention.
A total of 3,461 adverse reactions were reported to the government since the FDA approved the drug in June 2006. FDA and CDC officials caution against drawing any conclusions that would necessarily correlate the deaths or adverse reactions to the medicine.
The government reports on Gardasil were obtained in a Freedom of Information Act lawsuit by the government watchdog group Judicial Watch, which made them public.
Asked if the FDA has any regrets about approving the vaccine, agency spokeswoman Karen Riley said, "Absolutely not. We will continue to monitor it as we do with all drugs."
"This is unidentified data," Riley told Cybercast News Service, referring to the VAERS reports. "You can not establish a cause. All these cases have to be observed before you can draw a conclusion. Do you know the medical histories of these girls?"
Because of the nature of the raw data, just four of the deaths have been confirmed as actually taking place, according to CDC spokesman Curtis Allen.
The CDC determined that influenza was the cause of death for a 12-year-old girl from New York state who died six days after getting the Gardasil vaccine, and for a 15-year-old girl from Arizona who died four days after receiving the vaccine.
In two other cases, teen girls died of heart conditions that resulted from complications with birth control pills, Allen said.
Other cases couldn't be confirmed because of the raw data. For example, there were initially nine reports of fatalities, until it turned out that one girl reported dead was still alive, said Allen.
Another report quoted a nurse who cited another nurse as saying that an emergency room doctor had declared that the death of an 11-year-old girl in May was "due to an anaphylactic reaction to Gardasil."
However, when the FDA twice contacted the person who made the report, that person did not know the name of the patient, was not sure if she died, and would not say at which hospital the incident occurred, Riley said.
The government doesn't even know for sure there was a death of an 11-year-old, said Allen.
"There are any number of other potential causes for an allergic reaction, so this still would not necessarily mean that the vaccine caused the death even if we could confirm that there was death," he said.
Allen added that, on average, 10 percent of adverse reaction reports for other drugs are serious, while only 5 percent of reported reactions to Gardasil are serious.
The most consistent adverse reaction reported after Gardasil shots were administered included at least 13 cases of Guillain-Barre Syndrome (GBS), a disorder in which the immune system attacks nerves and can trigger numbness and paralysis.
The CDC responded to the reports this summer, saying that 13 reports of GBS are in proportion with the general population, with or without the Gardasil vaccination. Further, only two reported cases met the definition of GBS when further investigated.
Attorney John Driscoll is laying the groundwork for litigation against Merck based on the GBS cases. He hasn't filed a suit but is investigating the case that was first brought to his attention by the family of a girl from the Chicago area.
"A young lady, a minor, was administered the product, and very shortly after that symptoms of GBS developed," Driscoll told Cybercast News Service. "She was eventually diagnosed with GBS."
A handful of other clients have shown interest in the case, Driscoll said. The girl's family came to him in mid-summer, Driscoll said, so the process is in its early stages.
Merck spokeswoman Kelley Dougherty said: "We are not aware of any lawsuits filed in the United States at this time."
An adverse reaction could be any number of things, including complaints of pain from the shot, Dougherty said.
"Any events that could occur are consistent with what's listed on the label," Dougherty said. "There is no reason for a consumer not to have information."
She also wondered what interest Judicial Watch - which typically targets government corruption - had in the records.
"I do know it's odd that a group of attorneys, not medical professionals, would look at safety data," she said. "I can't comment on their motives."
After reviewing some of the documents his organization obtained, Judicial Watch President Tom Fitton anticipates a number of lawsuits.
"I'm sure the plaintiffs' lawyers are looking at this with interest," Fitton told Cybercast News Service. "Their targets could range from the drug company that manufactures it to the states that mandate it. Lawsuits are only limited by the imagination of the trial lawyers."
Fitton firmly believes that the deaths and adverse reactions that occurred after the Gardasil shots were more than a series of coincidences.
"If adults want to take Gardasil, fine," Fitton said. "But if a state mandates school children to get it, it's a poor public health policy choice."
'Good step' in reducing cancer
Three states - Massachusetts, New Jersey, and Virginia - mandated girls entering the sixth grade get the vaccine for HPV.
Meanwhile, 38 other states this year passed or considered some type of legislation either mandating, funding, or educating the public about the vaccine, according to the National Council of State Legislatures. New Hampshire and Alaska adopted a voluntary program that supplies the vaccine for free to girls ages 11 to 18 who want it.
After the FDA approved Gardasil, the Advisory Committee on Immunization Practices recommended routine vaccinations for girls ages 11 and 12. HPV infects 20 million people in the United States, with about 6.2 million new cases each year, according to the CDC. HPV is responsible for nearly 70 percent of cervical cancer cases.
The three states that passed the mandate included an opt-out provision that would let parents choose not to have the vaccine administered to their child for religious or other reasons.
"Virginia has a very broad opt-out policy if parents are concerned about safety - they don't have to give a reason," Virginia Gov. Tim Kaine's spokeswoman Delacey Skinner told Cybercast News Service. "The law was passed with strong support from the Department of Health as a good step in reducing the number of cervical cancer cases."
Nonetheless, in January, the American College of Pediatrics voiced opposition to mandatory HPV vaccinations.
"HPV is spread only by sexual intercourse," the national pediatricians' group stated. "Keeping children out of school because they have not been vaccinated with HPV vaccine is a serious, precedent-setting action.
"It replaces medical decision-making with government regulation, which should be reserved for the improvement of the general public health. HPV can not innocently be 'caught' in a classroom as measles or other preventable diseases can," it added.
A key criticism of the issue has been that Gardasil is being marketed as a cancer drug, when in fact it's a drug for a sexually transmitted disease.
Merck spokeswoman Dougherty disagreed with the critique.
"Virtually all cervical cancer is caused by HPV," she said. "HPV is the precursor to cervical cancer. Gardasil is proven by the FDA and World Health Organization's standards as the way to prevent cervical cancer."
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