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JWReportFDAhpvVaccineRecords

JWReportFDAhpvVaccineRecords

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06/27/2014

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 A Judicial Watch Special Report
Examining the FDA’sHPV Vaccine Records
 
Detailing the Approval Process, Side-Effects,Safety Concerns and Marketing Practices of aLarge-Scale Public Health Experiment
 June 30, 2008
 Judicial Watch, Inc.
501 School Street, SW
Suite 500
Washington, DC 20024 Tel: 202-646-5172
Fax: 202-646-5199
  www.JudicialWatch.org 
 
 Judicial Watch Special Report:
Examining The FDA’s HPV Vaccine RecordsPage 1 of 24
Introduction
This Judicial Watch Special Report is an analysis of records obtained from theFood and Drug Administration (FDA) concerning a recent vaccine called Gardasil.Gardasil helps protect against four types of human papillomavirus (HPV). The vaccinewas approved in May 2006 and was created and marketed by Merck & CompanyIncorporated.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 havedied after receiving Gardasil.
1
Many health officials believe that adverse reactions tomedications are widely underreported, therefore the actual number of adverse eventsoccurring 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 concerningGardasil, was originally submitted to the FDA on May 9, 2007. The FDA produceddocuments 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 isdesigned 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. Thevaccine 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 torequire, fund or educate the public about the HPV vaccine and 17 states have enactedlegislation. 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 eventreporting associated with Gardasil. Merck has waged an aggressive lobbying campaignwith state governments to mandate this HPV vaccine for young girls. Given all thequestions about Gardasil, the best public health policy would be to reevaluate its safetyand to prohibit its distribution to minors. In the least, governments should rethink anyefforts to mandate or promote this vaccine for children.Thomas FittonPresidentChristopher J. Farrell Tegan N. MillspawDirector of Investigations & Research Lead Researcher & Principal Author 
 
 Judicial Watch Special Report:
Examining The FDA’s HPV Vaccine RecordsPage 2 of 24
Executive Summary
In May 2007, Judicial Watch submitted a request to the FDA under the Freedomof Information Act for all records concerning Merck’s new anti-HPV vaccine, Gardasil.After Judicial Watch filed a lawsuit in October 2007 to compel record production, theFDA finally released four sets of documents, the last in June 2008. These records detailthe development and expedited approval of Gardasil. The documents include patent andlicensing memoranda, test reports for the vaccine, and the final briefing document onGardasil submitted to the FDA in April 2006, one month before the vaccine wasapproved. The FDA also produced 8,864 VAERS reports. Judicial Watch uncovered atranscript of Merck’s May 18, 2006, meeting with the Vaccines and Related BiologicalProducts Advisory Committee (VRBPAC), at which the vaccine received a unanimousvote of approval.Analysis of the records shows:
 
Gardasil is a prophylactic, preventative vaccine and will not treat pre-existingHPV infection. It is not a cancer vaccine or cure.
 
Gardasil is marketed as a vaccine that prevents cancer, but it “ . . . has not been evaluated for the potential to cause carcinogenicity or genotoxicity.”
 
Gardasil is not 100% effective against all HPVs. It is designed to protectagainst only four strains of HPV, even though there are over thirty strainsincluding at least fifteen that can cause cancer.
 
While Gardasil is the most expensive vaccine ever to be recommended by theFDA, its long-term effectiveness is unknown and could be as brief as only twoto three years.
 
During testing, an aluminum-containing placebo was used. Aluminum cancause permanent cell damage and is a reactive placebo, unlike most standardsaline placebos. This means that tests of Gardasil may not have given anaccurate picture of safety levels.
 
Although some states are considering making it mandatory for young girls toget the Gardasil vaccine, it has only been tested with one other vaccinecommonly given to children. There are ten commonly administeredadolescent vaccines.
 
Gardasil is still in the testing stages, and will not be fully evaluated for safetyuntil September 2009. VAERS reports show that as many as eighteen peoplehave died after receiving Gardasil.

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