(Washington, DC) – Judicial Watch announced today that it filed a Freedom of Information Act (FOIA) lawsuit against the Obama Administration’s Department of Health and Human Services (HHS) to obtain records related to the Vaccine Injury Compensation Program (VICP), a program that compensates patients who have been adversely affected by certain vaccines, including Gardasil, the vaccine for the sexually transmitted disease human papillomavirus (Judicial Watch v. U.S. Department of Health and Human Services (No. 1:13-cv-00197)).
Judicial Watch initiated an investigation of HPV vaccine Gardasil after the Food and Drug Administration (FDA) fast-tracked the vaccine for through the approval process in 2006. Since 2007, Judicial Watch has uncovered government records documenting thousands of adverse reactions associated with the vaccine, including seizures, paralysis, blindness, pancreatitis, speech problems, short term memory loss, Guillain-Barré Syndrome and death.
Judicial Watch seeks the following records pursuant to its November 1, 2012 FOIA request filed with the Health Resources and Services Administration, a component of HHS:
1. Any and all records regarding, concerning, or related to the inclusion of human papillomavirus (HPV) vaccines as covered vaccines under the Vaccine Injury Compensation Program (VICP).
2. Any and all records depicting the number of claims filed under the Vaccine Injury Compensation Program (VICP) for injuries or deaths allegedly associated with human papillomavirus (HPV) vaccines.
3. Any and all records depicting the amount of compensation paid to claimants under the Vaccine Injury Compensation Program (VICP) pursuant to claims related to injuries or deaths allegedly associated with human papillomavirus (HPV) vaccines.
HHS acknowledged receipt of Judicial Watch’s FOIA request on November 2, 2012. By law, HHS was required to respond no later than December 4, 2012. However, as of the date of Judicial Watch’s lawsuit, the agency has failed to provide responsive documents, indicate when a response is forthcoming, or notify Judicial Watch why the records should be exempted from disclosure.
VICP is a Health and Human Services program that compensates patients who have been adversely affected by certain vaccines. The HHS web site describes the program as a “no-fault alternative to the traditional tort system,” and it covers 16 specific classes of vaccines, including HPV vaccines which were added in 2007. The number of successful claims made under the VICP to victims of HPV will provide further information about any dangers of the vaccine, including the number of well-substantiated cases of adverse reactions.
According to the Annals of Medicine: “At present there are no significant data showing that either Gardasil or Cervarix (GlaxoSmithKline) can prevent any type of cervical cancer since the testing period employed was too short to evaluate long-term benefits of HPV vaccination.”
“From the very beginning the federal government has attempted to shield the public from the truth about Gardasil. Despite safety concerns, the vaccine continues to be pushed for both girls and boys. For the supposed most transparent administration in history to stonewall on an urgent matter of public health is particularly galling,” stated Judicial Watch President Tom Fitton.
In addition to obtaining records from the FDA through the agency’s Vaccine Adverse Event Reporting System (VAERS) which has documented thousands of adverse reactions to Gardasil, Judicial Watch also published a special report in 2008 detailing Gardasil’s approval process, side effects, safety concerns and marketing practices.
Judicial Watch Special Report:
Examining The FDA’s HPV Vaccine Records
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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. 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. Mandatory vaccination has been opposed by the American College of Pediatrics and The New England Journal ofMedicine. 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.
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.
Thomas Fitton: President
Christopher J. Farrell: Director of Investigations & Research
Tegan N. Millspaw: Lead Researcher & Principal Author
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Judicial Watch Special Report: Examining The FDA’s HPV Vaccine Records
Executive Summary: In May 2007, Judicial Watch submitted a request to the FDA under the Freedom of 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, the FDA finally released four sets of documents, the last in June 2008. These records detail the development and expedited approval of Gardasil. The documents include patent and licensing memoranda, test reports for the vaccine, and the final briefing document on Gardasil submitted to the FDA in April 2006, one month before the vaccine was approved. The FDA also produced 8,864 VAERS reports. Judicial Watch uncovered a transcript of Merck’s May 18, 2006, meeting with the Vaccines and Related Biological Products Advisory Committee (VRBPAC), at which the vaccine received a unanimous vote of approval.
Analysis of the records shows:
• Gardasil is a prophylactic, preventative vaccine and will not treat pre-existing HPV 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 protect against only four strains of HPV, even though there are over thirty strains including at least fifteen that can cause cancer.
• While Gardasil is the most expensive vaccine ever to be recommended by the FDA, its long-term effectiveness is unknown and could be as brief as only two to three years.
• During testing, an aluminum-containing placebo was used. Aluminum can cause permanent cell damage and is a reactive placebo, unlike most standard saline placebos. This means that tests of Gardasil may not have given an accurate picture of safety levels.
• Although some states are considering making it mandatory for young girls to get the Gardasil vaccine, it has only been tested with one other vaccine commonly given to children. There are ten commonly administered adolescent vaccines.
This is just a portion of the report introduction, please follow this link to read the full report: http://www.judicialwatch.org/documents/2008/JWReportFDAhpvVaccineRecords.pdf