Even as Gardasil side effect reports close in on the 10,00 mark, the feds are declaring the vaccine safe. This despite reports of at least 20 deaths following Gardasil, as well as dozens of other serious reactions, including Guillain-Barré Syndrome.
The Food & Drug Administration (FDA) and Centers for Disease Control (CDC) said yesterday that they have not been able to find a connection between the reports and Gardasil, so they are standing behind the vaccine. As of June 30, 2008, there have been 9,749 Vaccine Adverse Event Reporting System (VAERS) reports of adverse events following Gardasil vaccination. Of these, 6 percent were deemed serious.
But not to worry! “There was not a common pattern to the deaths that would suggest they were caused by the vaccine,” the FDA and CDC said in a statement. (Except that all of the victims received Gardasil. -Ed.)
Regarding other serious problems reported in relation to Gardasil, the CDC and FDA claimed the data “do not currently suggest an association” between Gardasil and the conditions.
Katherine Davison, 20, is just the latest Gardasil recipient to go public about the problems she suffered after receiving the controversial cervical cancer vaccine. Davison, who had two Gardasil shots along with her two younger sisters in November 2007 and January 2008, suspects it caused her to suffer a stroke.
After receiving her second dose of Gardasil, Katherine began feeling dizzy and developed flu-like symptoms on February 1. On February 2, her family doctor gave her a phenergan shot for vomiting believed caused by the flu. On February 3, Katherine lost feeling in the left side of her body, her left eye was drooping, her pupils were unevenly dilated, and the dizziness persisted. Physicians determined she suffered a stroke, but her doctors and doctors at Johns Hopkins were unable to determine the cause.
“Before the shot I was fine, and there is no reason I should have had a stroke,” said Katherine who says she still can’t sense pain or temperature on her left side, sometimes feels dizzy and tires easily, and takes seven medications daily.
Katherine’s mother, Mary Davison, said her family doctor told her not to bring her younger two daughters in for their third shot because of what happened to their big sister.
The family of Jenny Tetlock, a 13-year-old California girl who has been suffering from paralysis ever since receiving Gardasil, has started a blog to tell her story. Visitors to http://www.jenjensfamily.blogspot.com/ can also contact the family if they have experienced symptoms similar to hers. The family is hoping that such feedback will help Jenny’s doctors figure out if Gardasil, or some factor, is behind her symptoms.
Jenny’s story has been reported on CBS News and in “US News and World Report”. She started experiencing muscle weakness about a month after receiving Gardasil. Within 15 months, she was almost completely paralyzed. Her father has been waging a very high-profile campaign to get to the bottom of this mystery, and suspects her immune system’s reaction to Gardasil had something to do with Jenny’s condition.
Of course, Merck says Gardasil has nothing to do with Jenny’s symptoms. However, several other girls have experienced forms of paralysis after receiving Gardasil. Of 7,802 adverse events related to Gardasil reported to health officials between June 2006 and April 2008, 31 involved Guillain-Barré Syndrome, a neurological disorder that leads to temporary - though often complete - paralysis.
The mother of a 14-year-old girl named Katherine Kimzey also suspects Gardasil is behind her daughter’s debilitating headaches, fainting spells, and arthritis-like stiffness. Shortly after receiving the vaccine, Katherine became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Katherine’s mother, who spent time reading Gardasil adverse event reports after her daughter became ill, has her doubts about the drug’s safety. “When you read everybody’s stories, they’re too similar not to be related,” she said.
Is the Food & Drug Administration (FDA) taking Gardasil side effect reports seriously? Some are concerned that agency is not, especially in light of the FDA’s recent decision to add new warnings about side effects to the Gardasil label.
In June, the FDA and Merck decided to add warnings about minor side effects - joint and muscle pain, fatigue, physical weakness and general malaise - reported in relation to Gardasil. However, the new warnings make no mention of more serious side effects, such as paralysis and death, that have been reported. This, in spite of the fact that there have been 15 deaths and 31 instances of Guillain-Barré Syndrome reported in patients who received Gardasil between June 2006 and April 2008.
The FDA will not add those side effects to the Gardasil label because it says there is not enough conclusive evidence linking them to Gardasil. However, many are calling on the FDA to do more studies on Gardasil in light of the serious side effect reports.
Gardasil has been implicated in the several instances of paralysis, and two such cases have resulted in the filing of major lawsuits against Merck.
According to a recent article in US News and World Report, 13-year-old Jenny Tetlock began experiencing muscle weakness about a month after receiving Gardasil. Within 15 months, the California native was almost completely paralyzed.
According to US News, the girl’s father, Philip Tetlock believes Jenny may carry genes that predisposed her to problems with the Gardasil vaccine. At age 10, Jenny developed a rare skin disease called pityriasis lichenoides that’s thought to be triggered by an overactive immune system. Her father has been waging a very high-profile campaign to get to the bottom of this mystery, and suspects her immune system’s reaction to Gardasil had something to do with Jenny’s condition.
At least two other girls have experienced paralysis after being administered Gardasil, and both have filed suit against Merck. According to her lawsuit, Jessica Parsons, 15, has been ill and in and out of the hospital since she received Gardasil. Her lower arms and legs were paralyzed as a result, but she is now learning to walk again.
Brittany LeClaire, 13, alleges that she suffered paralysis as well within days of receiving her last dose of Gardasil. Following weeks of having to use a walker, Brittany still walks with a limp.