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Merck Defends Gardasil

Jul 9, 2008 | Parker Waichman LLP

With Gardasil side effect complaints nearing 8,000, it was only a matter of time before Merck & Co. would have to respond to the controversy.   Yesterday, the company issued a statement insisting that there were no safety issues with its controversial cervical cancer vaccine. It is doubtful though that Merck's reassurances will do much to quiet concerns about the potential risks of Gardasil.

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

But over the past year, concerns over the safety of the vaccine have mounted.   Yesterday, the Centers for Disease Control (CDC) announced that there were 7,802 reports of Gardasil side effects between June 2006 and April 2008 to the Vaccine Adverse Event Reporting System (VAERS).  About 7 percent of those reports were for serious problems. The CDC said 31 people developed Guillain-Barré Syndrome (GBS) - a neurological condition that leads to temporary paralysis - after receiving the vaccine.   Another 15 patients died after receiving Gardasil.

The VAERS report was preceded by several high-profile news stories about young women who experienced paralysis after receiving Gardasil. Lawsuits against Merck are pending in two of those cases. In a third, the father of a California girl is waging a very public campaign to try to determine if Gardasil is responsible for his daughter's near-total paralysis.

So far, the CDC has not been able to determine if any of these reactions were caused by Gardasil, but the concerns are expected to take a toll on sales of the vaccine.  Already, several drug industry analysts have downgraded Gardasil sales forecasts, a development that was followed by  drop in the price of Merck stock.  

In an attempt to stem the bleeding, Merck issued a statement saying it had analyzed relevant data relating to the side effects, and concluded the reported events could be seen in the general population, even in the absence of vaccination.  So basically, the company is considering these incidents to be  coincidences. The statement said Merck is still "confident in the safety profile of Gardasil".

Both the CDC and Merck said they will continue to study the Gardasil side effect reports. Still Merck is standing by Gardasil, and the CDC has not changed its recommendation that young girls be given this questionable drug.

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