Judicial Watch, the US-based public interest group that investigates and prosecutes government corruption, obtained information about Gardasil from the U.S. Food and Drug Administration under the provisions of the Freedom of Information Act. The first 6 pages of the Judicial Watch Special Report Examining the FDA’s HPV Vaccine Records are posted below.
At the end of page 4 and on page 5 is evidence which shows that the HPV vaccine has led to outbreaks in warts in some people, which was denied as occurring by Dr Nikki Turner of the NZ Immunization Advisory Center.
Furthermore, at the end of page 5 and at the top of page 6 is mention that Gardasil was found to enhance disease in recipients who already had “relevant HPV types” by 44.6 percent. In spite of this Helen Petousis-Harris of the NZ Immunisation Advisory Center stated in a letter to The Whangarei Report: “There is no evidence that Gardasil increases the risk of precancerous lesions.” It states on the Gardasil insert in section 14: “Infected women may already have CIN 2/3 or AIS at vaccination onset and some will develop CIN 2/3 or AIS during followup, either related to a vaccine…”
Judicial Watch findings are summarized in an article entitled Controversial HPV Vaccine Causing One Death Per Month: FDA Report by Peter J Smith and the Judicial Watch document cited is in full here. On the 27th of March, when one clicked on this link, a web page appeared which dissuaded people from accessing this information, by claiming the site could damage your computer, which is why I posted these 6 pages on this website. However, since writing this post, the warning page has been removed. If it is up again when you look and you are willing to take a risk, click on “Ignore this warning” at the bottom right-hand-side of the red panel. I did repeatedly and nothing adverse appears to have occurred to my computer.
A Judicial Watch Special Report
Examining the FDA’s
HPV Vaccine Records
Detailing the Approval Process, Side-Effects, Safety Concerns and Marketing Practices of a Large-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 Records
Page 1 of 24
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.
Christopher J. Farrell Tegan N. Millspaw
Director of Investigations & Research Lead Researcher & Principal Author
Judicial Watch Special Report: Examining The FDA’s HPV Vaccine Records
Page 2 of 24
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 aluminium-containing placebo was used. Aluminium 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
• Gardasil is still in the testing stages, and will not be fully evaluated for safety until September 2009. VAERS reports show that as many as eighteen people have died after receiving Gardasil.