Gardasil Side Effect Reports Raise Doubts over Efforts to Make Cervical Cancer Vaccine MandatoryOct 30, 2007 | Parker Waichman LLP
Gardasil, the much-touted vaccine against cervical cancer, has been linked to some very serious side effects. Those reports have called into question efforts in many states to make Gardasil a mandatory vaccination for young girls.
Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck & Co., the maker of Gardasil, said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the 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.
Following its approval, the Centers for Disease Control recommended that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Merck has been lobbying states ever since to make Gardasil vaccinations mandatory for young girls. Merck’s heavy promotion of Gardasil has been effective, as some analysts estimate that Gardasil could net the company as much as $1.4 billion in its first full year on the market.
Since its approval, Merck has claimed that Gardasil is practically side effect free, with pain at the injection site being the most common complaint about the vaccine. But recently, the conservative group Judicial Watch obtained documents from the FDA that indicates that assertion could be false. What is very telling is that Judicial Watch had to force the FDA to turn over some Gardasil documents by filing a Freedom of Information Act request because they weren’t publicly available.
What the FDA documents revealed should cause state lawmakers to consider any proposal to make the Gardasil vaccine mandatory with cynicism. Since its approval, there had been 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil. According to Judicial Watch, in several instances, blood clots were reported to have occurred after the administration of Gardasil. Other side effects including paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures were also reported. Of the 77 women who received the Gardasil vaccine while pregnant, 33 experienced side effects ranging from spontaneous abortion to fetal abnormities.
Both Merck and the FDA insist that the side effects reports on Gardasil are no different than other drugs, and that none of the adverse reactions have yet to be directly connected to the vaccine. But Judicial Watch says that statistically speaking, it is doubtful that all of the side effects that have been reported in relation to Gardasil could be coincidence. Until more is known about Gardasil side effects, only parents should decide whether or not their daughters receive this vaccine.