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Gardasil Requirement Effort Fell Flat

Sep 2, 2009 | Parker Waichman LLP Three years after Gardasil first appeared on the market, Merck & Co's heavy handed attempts to convince states to make it mandatory for young girls appear to have had little success. According to the Associated Press, only Virginia and Washington D.C. have instituted loose Gardasil requirements for sixth-grade girls.  In both instances, parents may opt-out of the requirement for any reason, the Associated Press said.

Gardasil has been the subject of controversy ever since it was approved in 2006. Recently, a new study in the Journal of the American Medical Association found that Gardasil has a higher incidence of blood clots reported. Last month CBS News reported that  Merck is also looking into cases of ALS (Lou Gehrig’s Disease) reported after vaccination, and is monitoring the number of deaths reported after Gardasil is administered. Right now, that number stands at 32.

In June, the Food & Drug Administration (FDA) announced that the Gardasil label had been updated to include more prominent warnings about fainting that can occur following administration of the vaccine. According to the agency, some Gardasil fainting victims have suffered from tonic-clonic (jerking) movements and seizure-like activity, and some have fallen resulting in traumatic injuries. According to roughly 13% of Gardasil side effects reported to its Vaccine Adverse Event Reporting System (VAERS) describe fainting.

According  to the Associated Press report, while 2 dozen states had considered making Gardasil mandatory for young girls, those efforts failed because of parental opposition.   Reasons for such opposition are varied.  Safety was obviously a big concern, and some socially conservative people worried Gardasil would promote promiscuity.  Some states that considered providing Gardasil free-of-charge did not have the funding available once the economy fell into recession.   Finally, many people were disturbed to hear that Merck had paid for the massive lobbying efforts that were pushing for mandatory Gardasil.  Merck suspended that campaign in 2007, the Associated Press said.

According to the Associated Press, the Virginia and Washington, D.C Gardasil requirements go into effect this school year.  In Washington, sixth-grade girls will not be allowed to attend school unless they have had Gardasil, or their parents provide the school with a form indicating they have opted out.  In Virginia, parents are asked to provide documentation if their daughter had Gardasil, but there is no penalty for not doing so.  

In Texas, Gov. Rick Perry had tried to order a Gardasil mandate in 2007, but was over- ruled by the state legislature.  That same year, New Mexico Gov. Bill Richardson vetoed a mandate passed by that state's legislature.

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