Healthy Skepticism Library item: 13888

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Publication type: report

Judicial Watch
Examining the FDA’s HPV Vaccine Records
Washington DC: Judicial Watch 2008 Jun 30
http://www.judicialwatch.org/documents/2008/JWReportFDAhpvVaccineRecords.pdf

Abstract:

This Judicial Watch Special Report is an analysis of records obtained from the
Food and Drug Administration (FDA) concerning a recent vaccine called Gardasil.
Gardasil helps protect against four types of human papillomavirus (HPV). The vaccine
was approved in May 2006 and was created and marketed by Merck & Company
Incorporated.
The records include Merck’s patent and drug information submitted to the FDA,
transcripts and briefing material from approval meetings, and reports documenting health,
safety, and efficacy test results, as well as Vaccine Adverse Event Reporting System
(VAERS) documents detailing 8,864 cases of adverse effects experienced by people after
receiving the Gardasil vaccine. VAERS reports show that at least eighteen people have
died after receiving Gardasil.1 Many health officials believe that adverse reactions to
medications are widely underreported, therefore the actual number of adverse events
occurring after vaccination with Gardasil is likely to be higher.
Judicial Watch obtained these records under the provisions of the Freedom of
Information Act (FOIA), 5 U.S.C. § 552. The request, asking for documents concerning
Gardasil, was originally submitted to the FDA on May 9, 2007. The FDA produced
documents on May 15, 2007; September 13, 2007; February 27, 2008, and June 10, 2008.
Judicial Watch uncovered thousands of pages of material pertaining to Gardasil, which is
designed to prevent cervical cancer. The controversial vaccine was fast-tracked for
approval by the FDA despite concerns about Gardasil’s safety and long-term effects. The
vaccine is still in the testing stages (final report due September 30, 2009), but it is already
being administered to thousands of young girls and women.2 Mandatory vaccination has
been opposed by the American College of Pediatrics and The New England Journal of
Medicine. Legislators in 41 states and Washington, DC have introduced legislation to
require, fund or educate the public about the HPV vaccine and 17 states have enacted
legislation. Michigan, Texas and Virginia took steps toward mandatory vaccination for
sixth grade girls; however, all three states have postponed that required mandate.3
Judicial Watch is concerned by the facts detailed in the FDA’s adverse event
reporting associated with Gardasil. Merck has waged an aggressive lobbying campaign
with state governments to mandate this HPV vaccine for young girls. Given all the
questions about Gardasil, the best public health policy would be to reevaluate its safety
and to prohibit its distribution to minors. In the least, governments should rethink any
efforts to mandate or promote this vaccine for children.