Tag: warts

The First Six Pages of the Judicial Watch Special Report Examining the FDA’s HPV Vaccine Records

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 Gardasil VaccineExamining 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.

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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
Introduction

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.
Thomas Fitton
President
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

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 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
adolescent vaccines.
• 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.
Read more

Serious Adverse Reactions To Gardasil Swept Under Carpet By Dr Nikki Turner of NZ’s Immunization Advisory Centre

Gardasil Vaccine
On the 24th of February, Dr Nikki Turner of the Immunisation Advisory Centre gave a presentation about Gardasil to 28 members of the public in Whangarei at the Forum North events centre.   Although people were advised by The Whangarei Report that this meeting was to help them become informed, in my opinion, it was designed to do anything but.  The public were treated like mushrooms by Dr Turner – they were fed manure and kept in the dark.
At the start of the meeting Dr Turner was asked for clarification on whose data she was presenting and when she stated that it was derived from Merck, the manufacturer of Gardasil,  I advised that a whistleblower who had worked for Merck had indicated that their research data on the HPV vaccine was not trustworthy.  While Dr Turner did not dismiss this claim, she did not seem particularly concerned and moved back to the presentation.
On the topic of warts Dr Turner mentioned that Gardasil was useful in preventing these.  When I questioned her about the reports of people getting warts as a result of having the vaccine, she denied that this was occurring and implied the media had misled the public.   The media has not.  Here are 3 excerpts published on pages 4 and 5 of a Judicial Watch report on the Gardasil vaccine that link shots to the subsequent development of warts:
Two days after receiving the first dose of Gardasil, the patient developed groin warts. There is no known history of these warts. The patient came back in about a month later and was given the second dose of Gardasil.
days after receiving the second dose, the patient had a huge outbreak of warts.   VAERS ID: 292052-1

Information has been received from a consumer concerning her 17-year-old daughter with no medical history and an allergy to sulfa, who on 28-SEP-2007 was vaccinated with a first dose of Gardasil . . . Prior to being vaccinated with Gardasil the patient was tested for HPV and genital warts and all her test came back negative. On 15-OCT-2007 the patient experienced a fever, and broke out with white bumps that were diagnosed as genital warts. VAERS ID: 301339-115


“Outbreaks were not limited simply to genital warts. Some patients experienced outbreaks of warts on the face, hands, and feet. All warts are caused by strains of the papilloma virus, but it is surprising that Gardasil, which was modeled to protect only against genital warts, would cause outbreaks of warts caused by other strains of the papilloma virus.” (Refer p. 5).
The VAERS reports Judicial Watch acquired included 78 separate cases where, after receiving the vaccine, patients experienced outbreaks of warts.
What was most disturbing about this presentation, was that while she mentioned that a variety of organisations were collecting information on the adverse reactions that were occurring, such as the VAERS,  she failed to mention the thousands of adverse reactions and the deaths that have been reported to the bodies.   Instead she minimized the problems and claimed that a major concern with this vaccine was that girls were “fainting,”  which she implied was simply due to being pricked by a needle.
pinocchio-girl1
The only serious adverse reactions she mentioned as having occurred related to two girls in Spain.  She said Spanish health authorities had withdrawn tens of thousands of doses of the HPV vaccine because two girls fell seriously ill after receiving doses of it. Tellingly, Dr Turner put what happened in Spain down to a bad “batch,” while failing to mention that similar serious adverse reactions were being reported elsewhere, and in large numbers, including by the mainstream media.

As she had minimised the adverse reactions, when she asked if anyone had any questions at the end of the presentation, I said: “In October 2008, over 10,000 adverse reactions, including 27 deaths had been reported to the Vaccine Adverse Event Reporting System in relation to Gardasil. Yet, the CDC and the FDA are alleging that the vast majority , or even all of these cases are not related to the vaccine. They are therefore saying Gardasil is “safe.” Could you tell me why the documents related to how they arrived at this decision that it is safe, in spite of all the adverse reactions that have been reported, are being kept hidden from the public?”
She answered by saying that she was aware of the reactions that had been reported.  She did not answer the question as to why the documents were being kept from the public though.

For more information, refer:

How the U.S. Government is Covering Up HPV Vaccine Side Effects, http://articles.mercola.com/sites/articles/archive/2008/11/15/how-u-s-government-is-covering-up-hpv-vaccine-side-effects.aspx

A Judicial Watch Special Report, Examining the FDA’s HPV Vaccine Records.  The first 6 pages are posted here:  http://uncensorednz.wpengine.com/2009/03/27/a-judicial-watch-special-report-examining-the-fda%E2%80%99s-hpv-vaccine-records/

The report in full  is at this link – click on “Ignore the warming” at the bottom of the right-hand-side of the red panel if you are willing to take a risk:  http://www.judicialwatch.org/documents/2008/JWReportFDAhpvVaccineRecords.pdf

Immunisation Advisory Centre: Gardasil Deaths “Mainly Motor Vehicle Accidents”

http://forum.prisonplanet.com/index.php?topic=88272.0

Growing Controversy Over New Merck Vaccines, http://articles.mercola.com/sites/articles/archive/2007/03/10/growing-controversy-over-new-merck-vaccines.aspx

NZ’s Immunisation Advisory Centre Claims Gardasil Deaths Mainly “Motor Vehicle Accidents”  http://uncensorednz.wpengine.com/2009/02/26/nzs-immunisation-advisory-centre-claims-gardasil-deaths-mainly-motor-vehicle-accidents/