Gardasil Associated with ParalysisJul 7, 2008 | Parker Waichman LLP
Gardasil has been implicated in the paralysis of a 13-year-old girl who developed a degenerative muscle disease shortly after receiving the vaccine. Meanwhile, Merck, the maker of Gardasil, has been named in two lawsuits that allege the vaccine caused paralysis in two other girls.
Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co. said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of Human Papillomavirus (HPV) that cause cervical cancer. The approval of Gardasil was much hyped, with Merck claiming that it had the potential to eventually eliminate most cervical cancers.
Recently, the FDA refused to approve the use of Gardasil in women ages 27-45, but Merck is working to convince the agency to approve it for boys.
Merck claims Gardasil is practically side-effect free. But reports in the last year have contradicted those claims. A 2007 analysis by Judicial Watch of Gardasil adverse event reports revealed that there had been at least 3,461 complaints of adverse reactions to the Gardasil vaccine. Since the Judicial Watch report, more Gardasil adverse events have been reported to the FDA. Those reports now total 8,000 and 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 deaths.
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. Both Merck and the FDA have dismissed suggestions that Jenny's condition is related to Gardasil.
But the girl's father, a psychology professor at UC-Berkley, is not convinced that Gardasil did not play some role in his daughter's illness. According to US News, 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, and her grandmother died of a nervous system disease.
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. 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.
Unfortunately, Gardasil has not been subjected to enough testing to insure its safety. Even one of the researchers who worked on this vaccine has made this argument. In May, Dr. Diane Harper, a top expert on the HPV who, while working as a professor at Dartmouth College, served as a researcher on study trials for Gardasil, questioned efforts to make the vaccine mandatory.
In an interview with a Florida TV station, Dr. Harper said that there has not been enough post-marketing surveillance of Gardasil to insure that it is free of side effects that could prove particularly dangerous to young girls. “We don’t know yet what’s going to happen when millions of doses of the vaccine have been given and to put in place a process that says you must have this vaccine, it means you must be part of a big public experiment. So we can’t do that until we have more data.” she said.