Gardasil, the much-touted vaccine against cervical cancer, might not be as safe as once thought. The conservative group Judicial Watch has obtained documents that indicate that Gardasil may have been responsible for thousands of serious injuries, including blood clots and seizures, and possibly several deaths. The new Gardasil revelations are disturbing, as efforts are underway in several states to make the vaccine mandatory 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 (CDC) recommended that all young girls between the ages of 11 and 12 receive the Gardasil vaccine. Merck was more than happy to echo the CDC recommendations, and actually began an intensive lobbying effort to convince state health authorities 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. However, a recent Judicial Watch analysis of the FDA’s Vaccine Adverse Event Reporting System reveals that Gardasil has not been as side effect free as Merck claims. Oddly, Judicial Watch was only able to obtain the FDA’s reports on Gardasil after it filed a Freedom of Information Act request with the agency. While Judicial Watch is a conservative organization with a definite agenda of its own, what it has uncovered about Gardasil is still disturbing.

Since its approval, there have 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. Yet it seems hard to believe that all of the adverse reports linked to Gardasil could be coincidence. And taken in this light, it would seem that efforts to make the Gardasil vaccine mandatory are ill advised until more research can be done on Gardasil’s potential side effects.

This entry was posted on Monday, October 8th, 2007 at 9:49 am and is filed under Legal News.