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Two Die Following Gardasil Shots

Jun 12, 2008 | Parker Waichman Alonso LLP

Gardasil has been implicated in the deaths of two more young women, the European Medicines Agency (EMEA) has reported.  Though no official cause of death has been listed, the  young women apparently died shortly after receiving  Gardasil, and the EMEA is characterizing their deaths as "sudden and unexpected."  

The two deaths bring the total number of fatalities possibly linked to the Merck cervical cancer vaccine to five.  In the U.S., three young women have reportedly died after receiving Gardasil.  However, there could be more such incidents, as health officials believe that adverse effects of medication are widely underreported.

Gardasil was approved by the U.S. 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 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.

Just weeks after its approval, the U.S. 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 has made similar efforts in Europe.  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.

But Gardasil may not be as safe as Merck 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, 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. As some have pointed out, Judicial Watch is a conservative organization with an agenda. But Judicial Watch did not fabricate these adverse event reports, and the seriousness of some of them indicate a need for further investigation.

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.