Gardasil, the FDA, and VAERS: How Americans concerned about vaccines interact with government

Understanding Government

Better Government through Better Reporting

By Marci Greenstein | 14. December 2010

Emily Tarsell thought she had enough information about Gardasil — a new vaccine marketed to young women to prevent certain types of cervical cancer — when she agreed to have her daughter receive the vaccine.  But after her third and last injection of Gardasil, in 2008, Christina Tarsell, a previously healthy 21-year old, was dead.

The depth of this family’s anguish at the death of their daughter can’t be conveyed.  But after some time, and after realizing the possible link between Gardasil and her daughter’s death, Emily Tarsell decided she must try to find out if the vaccine was responsible. Thus began a real-life, real-time case study of how the Food and Drug Administration responds to citizens’ inquiries about possibly dangerous vaccines.  Unfortunately, Tarsell would discover that the Food and Drug Administration’s system for monitoring adverse reactions to vaccines and informing the public about them was woefully inadequate.

The Tarsells are not the only family that has tried to navigate the FDA’s reporting system for vaccines, known as the Vaccine Adverse Event Reporting System or VAERS.  The FDA has called VAERS the “front line of defense” in vaccine safety, while admitting that the system has serious limitations.  First and foremost among these limitations is that VAERS is a “passive,” or voluntary, reporting system – which may explain why, according to FDA estimates, only 10% of adverse reactions to vaccines are reported.  In addition, anyone can file a report with VAERS, from patients to pharmacists to physicians to vaccine manufacturers.

Manufacturers can filter vaccine concerns

But perhaps the biggest problem with VAERS is that citizens who are concerned about vaccines are encouraged to interact not with the FDA or other government agencies, but instead with vaccine manufacturers.  According to at least one critic, that makes VAERS reports unreliable from the start.  Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center (NVIC), a vaccine watchdog group, says “there are no incentives for manufacturers to report [adverse events].”   A drug manufacturer that has spent years and vast sums of money to get a drug to market has little incentive to report information that could affect the vaccine’s reputation.  At the same time, once a vaccine has been approved for use, it can be “tested” on a larger and more diverse population than in pre-licensing clinical trials, which is why monitoring the safety of newly-approved vaccines is so important.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.