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Efforts to Make Gardasil Mandatory Stall in Some States

Apr 24, 2008 | Parker Waichman Alonso LLP

Merck Inc.'s efforts to make the controversial Gardasil vaccine mandatory for young girls has hit a roadblock in one state.  In February, the Massachusetts State Senate sent a Gardasil bill “to study,” making it unlikely that a vote on the proposed legislation will occur in the 2008 legislative session.

Gardasil, approved by the Food & Drug Administration (FDA) in 2006 is meant to protect against several forms of the Human Papillomavirus (HPV) that cause cervical cancer.  The vaccine has been much hyped, and Merck has waged an aggressive campaign to convince state legislatures to make it mandatory for girls before they are likely to become sexually active.  Recently, 20 states pushed for federal mandates to make Gardasil mandatory for sixth grade girls.

But many parents are opposed to making the vaccine mandatory, and in some states, like Massachusetts, the efforts have stalled.  Some parents are opposed to mandatory vaccination on moral grounds, believing that vaccinating their daughters against a sexually transmitted disease sends the message that sexual activity at such a young age, or even prior to marriage, is acceptable. Others simply believe that the government has no right to usurp parental authority by mandating a vaccine for a disease that is not spread through casual contact.  Still others worry that Gardasil is too new, and hasn't been subjected to enough scrutiny.  They fear harmful Gardasil side effects may not become apparent for several years, and would like to wait before subjecting their daughters to the vaccine.

When it was approved, Merck said that Gardasil was virtually side effect free. But some dispute this, and point to adverse events reported to the FDA that seem to be associated with the administration of Gardasil.  Supporters of Gardasil argue that it has not been proven that the vaccine had anything to do with any of the reported side effects.  But vaccine critics say a link has not been disproved either, and argue that the existence of the reports warrants further study of the vaccine's safety.  

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.

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.

The Gardasil controversy won't go away anytime soon, especially if the FDA continues to reject calls for more studies on Gardasil side effects.  Right now, the only recourse is for parents opposed to mandatory Gardasil vaccination to make sure lawmakers know how they feel.  With so much uncertainty about Gardasil side effects, the decision whether to vaccinate or not should be left with parents.