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Gardasil Vaccine Side Effects Reason for Concern

Mar 3, 2008 | Parker Waichman LLP Gardasil, the HPV vaccine marketed by Merck has been the subject of controversy ever since it was approved by the Food & Drug Administration (FDA) in 2006.  While some conservative groups oppose Gardasil for philosophical and moral reasons, other patient advocates are disturbed by Gardasil side effect reports and the aggressive campaign Merck has waged to make the vaccine mandatory for girls in the US.

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.  Merck also claimed that Gardasil was practically side effect free.

The claims of few Gardasil side effects, however, are not borne out by the FDA's own statistics.  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, 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. The Gardasil side effect  reports also included 28 women who miscarried after receiving Gardasil. Other side effects reported to the FDA included paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures were also reported.   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 does promote a conservative agenda, it's findings on Gardasil are still cause for concern.

There have also been a handful of deaths that occurred following the administration of Gardasil.  Three young women in the US died shortly after receiving Gardasil, while two other women in Europe also died after the vaccine was administered.  Despite all of these reports, Merck continues to market Gardasil as virtually side-effect free.  Thus far, the FDA has refused to conduct a formal safety review of Gardasil.

But Merck has done more than simply market Gardasil.  The company has waged an extremely aggressive campaign to make Gardasil mandatory for young girls.  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 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.  Recently, 20 states pushed for federal mandates to make Gardasil mandatory for sixth grade 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.

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