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Gardasil Vaccine - Deaths And Adverse Reactions Update
By Alliance for Human Protection www.ahrp.org
July 02, 2008

Though approved for marketing by the FDA in May 2006, Merck's HPV vaccine, Gardasil, is still in the testing stages, and will not be fully evaluated for safety until September 2009.

Gardasil gained FDA approval under a fast track process--within 6 months of testing. Fast-track approval is a process reserved for life-saving products with the potential to fill an unmet medical need, such as, new cancer treatments or AIDS drugs.

A special report issued by Judicial Watch, "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" is (June 30, 2008) shows that aggressive lobbying by Merck--rather than medical need backed by scientific data--led the FDA to approve Gardasil before adequate testing for safety had been completed.

The report is a MUST READ for every parent considering vaccinating a daughter with Merck's papillomavirus (HPV) vaccine, Gardasil. The report should be required reading for every public health official and policy maker. See Examining the FDA’s HPV Vaccine Records

Thousands of documents were obtained by Judicial Watch after filing a lawsuit against the FDA. The documents 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.

VAERS reports provide details about 8,864 cases of adverse effects experienced by girls and women after receiving the Gardasil vaccine.

Since January 2008, the FDA identified 140 as "serious" reports (27 were categorized as "life threatening"), 10 spontaneous abortions and 6 cases of Guillain-Barre Syndrome. VAERS reports show that at least eighteen people have died after receiving Gardasil. See adverse effect reports submitted to VAERS.

Adverse report excerpts include:

* Information has been received...concerning a 20 year old female with no medical history reported, who on 01-APR-2008 was vaccinated with a dose of Gardasil....The patient died four days after...patient sought unspecified medical attention. An autopsy was performed which ruled out suicide and anything suspicious. The cause of death is currently unknown. VAERS ID:310262-1 (D)

* Information has been received.concerning a 23-year-old female.who on 31-JAN-2008 was vaccinated with her 1st dose of Gardasil...the patient experienced anaphylactic shock 2 minutes after vaccination characterized by a brief loss of consciousness...respiratory arrest, eyes rolled upwards, blurred vision and greyish skin tone ... Anaphylactic shock was considered to be immediately life-threatening. VAERS ID: 304739-1 (S)

* Cold sweat, Fall, Foaming at mouth, Grand mal convulsion, Immediate post-injection reaction....Pt [patient, 14-year-old female] received vaccine, took 6 steps, fell to the ground unconscious and had a 60 sec grand mal seizure then regained consciousness. [Blood pressure] after seizure 60/40 pale clammy skin. [Patient] had bit her tongue and had foam around her mouth. VAERS ID: 305259-1 (S)

* Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with a dose of Gardasil. Subsequently, the patient experienced a coma and is now paralyzed. At the time of this report, the patient's outcome was unknown. VAERS ID: 303188-1

Most health officials believe that adverse reactions to medications are vastly underreported, as they are optional. Safety experts estimate that only between 1% and 10% of adverse effects are reported. Therefore the actual number of adverse events occurring after vaccination with Gardasil is likely to be much higher.

Based on the reports submitted to the VAERS database, Gardasil is demonstrably a risk-laden vaccine.

Even without Gardasil, cervical cancer deaths have decreased drastically in the past several decades. The American Cancer Society estimates that deaths from cervical cancer declined 74% between 1955 and 1992, and that the rate continues to decrease by about 4% each year.

Since condoms are indisputably a safe, non-invasive, cost-effect method for protecting boys and girls / men and women against ALL sexually transmitted diseases -- Why are we exposing American girls and young women to a public health experiment whose benefits are unclear while its risks include death ?

Below is the Executive Summary of Judicial Watch's special report.

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org

Judicial Watch Special Report:
Examining The FDA's HPV Vaccine Records

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.

* 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.