Fed's are probing into records of over 8,000 adverse events reported since the 2006 FDA approval of the Merck vaccine touted as an HPV cancer preventative. Side effects reported include paralysis, immune system disorders and a record of 18 possible deaths
"I Want To Be One Less" - the familiar slogan of the heavily advertised vaccine may prove to be more fatal that fabulous.
We're all familiar with the catchy phrases, the jump rope ads, the clever rhythmical lyrics that accompany the commercials for Gardasil. Advertised heavily across the US and abroad, Gardasil has been touted as a "must have" vaccine for girls aged 9 thru 26. TV screens and movie theatre ads have been singing the praises of the drug, claiming that it is a preventative against HPV (human papillomavirus), which is the main cause of cervical cancer.
Sold throughout the world, at an average cost of $360.00 per treatment (3 doses are required over a period of several weeks), it is estimated that over 8 million US girls and women have received the drug in the past 2 years. Security and Exchange Commission records show that Merck and Co. has profited 1.5 million last year alone from the sale of Gardasil. Immediately following it's FDA approval, Merck went on a nationwide campaign to make the vaccine mandatory, actively urging legislatures in all 50 states to pass laws requiring all school aged girls to be treated with the drug. Following heaving criticism from the media and other organizations, Merck dropped the push for state mandates in February 2006, instead concentrating on major ad campaigns urging the general female population to obtain the vaccine in order to prevent cervical cancer. Texas was the only state to pass laws mandating the vaccine before Merck withdrew it's efforts.
Lawyers in the last month have filed the first two claims on behalf of girls with ailments blamed on Gardasil under a federal program to compensate victims of vaccine-caused illness. Under the federal law passed in the late 1980s, victims of vaccines may file a claim under the Vaccine Injury Compensation Program, but cannot sue the pharmaceutical company. Last year, the government added HPV to a list of vaccines, including polio, hepatitis and measles, granted immunity from suit. A New York Post analysis of adverse event reports filed through April 30 of 2008 found that about 20 percent of such reports followed injections of Gardasil.
If victims prove a vaccine likely caused injuries, the program pays a maximum $250,000 for death. The average payment for injury has been $1 million.
Gardasil has a laundry list of reported "incidents" - 8,000 to date - which include nausea, vomiting, seizures, paralysis, autoimmune disorders and 18 deaths which are under investigation due to the timing between the receipt of the vaccine and the young women's death.
The current suits filed on behalf of two young girls reported the following adverse reactions following the vaccinations - both of which were received by the girls in their middle schools.
One is Jesalee Parsons, now 15, of Oklahoma, who began vomiting the day she got a Gardasil shot and developed pancreatitis, her claim says.
"It makes me mad because they're saying how great it is, but they never mention how many people have been hurt by it," Jesalee told The Post.
Healthy all her life, her family says, Jesalee has been hospitalized on and off for more than a year. She restricts her diet, takes pain pills and misses many school days.
"I'm pretty sick all the time," she said.
The other claim was filed for Jessica Vega of Nevada, who came down with Guillain-Barré Syndrome, an immune-system disorder, at age 14 - a week after her second Gardasil shot.
Thirty others have reported the syndrome after getting the vaccine.
Jessica's mother, Rhonda Vega, told the Post that her daughter's lower arms and legs were paralyzed as a result of the shots, but she is now learning to walk again.
13-year-old Brittany LeClaire's mother, Christina Bell, reported that her daughter suffered paralysis as well within days of receiving her last dosage of the vaccine. She began having severe headaches and lethargy immediately after the injections, and then developed paralysis in her left leg. Following weeks of having to use a walker, Brittany still walks with a limp.
Christina said her doctor "highly recommended" the vaccine. "He told me it was a cancer preventative. I thought it was the right thing to do. You see it advertised on TV every 15 minutes."
The Vaccine Adverse Event Reporting System, run by the FDA and the Centers for Disease Control and Prevention, has collected thousands of reports of health problems after Gardasil shots.
The fatalities include:
* A 17-year-old New York girl who collapsed and died on Feb. 22 this year, two days after the last of three Gardasil injections. An autopsy could not pinpoint the cause, but doctors suspect a heart-rhythm disorder.
* An 11-year-old who suffered a heart attack in May 2007, three days after a Gardasil shot. The nurse who reported it said a doctor blamed it on "an anaphylactic [severe allergic] reaction to Gardasil." The feds could not confirm the case.
* A 12-year-old girl with no prior medical problems who died in her sleep on Oct. 6, 2007, three weeks after a Gardasil shot.
Dr. John Iskander, the CDC's acting director for immunization safety, says that the CDC has investigated 10 of the reported deaths and has found no conclusive evidence linking the vaccine. He went on to state that "although it is sad that young, healthy young women die for no apparent reason" there was no conclusive evidence that Gardasil had created the adverse reactions experienced by the dead women, or those suffering from seizures, paralysis and brain damage. The only common side effect of the vaccine, according Dr. Iskander, is fainting.
Merck spokeswoman Kelley Dougherty backed up Iskander's findings, and stated that the company "actively monitors" reports of side effects.
"An event report does not mean that a causal relationship between an event and vaccination has been established - just that the event occurred after vaccination," she said.
Spoken like a true government representative and pharmaceutical company spokesperson, wouldn't you agree?