Records obtained by Judicial Watch under the Freedom of Information Act show 47 deaths and thousands of serious adverse events associated with Gardasil.
Last year, clinic staff and family members told the Food and Drug Administration (FDA) that the Gardasil vaccine was responsible for 28 deaths of girls and young women.
The deaths included several girls ages 11 and 12 who had no existing medical conditions prior to receiving the vaccine. In some cases, the girls died within three days of receiving one shot of the vaccine. Others died following their third Gardasil injection. Several died in their sleep.
Gardasil is a vaccine marketed by the pharmaceutical company Merck (Click here for some history of MERCK)and recommended by U.S. public health authorities for the prevention of human papillomavirus (HPV) in girls and young women. HPV is the leading cause of cervical cancer in women.
Gardasil has been implicated in 47 deaths since gaining FDA approval in 2006, according to data voluntarily submitted to the FDA by physicians, hospital staff and family members.
FDA records also show 6,723 "adverse events" were reported following Gardasil vaccinations in 2008, ranging from genital and facial warts and permanent disability to cervical cancer and Guillain-Barre Syndrome.
Of the total 47 reported deaths, 41 occurred within a month of receiving the vaccine.
The FDA’s Vaccine Adverse Event Reporting System (VAERS) records, a voluntary reporting system, were obtained under the Freedom of Information Act by Judicial Watch, a government watchdog group.
The following are several "adverse events" documented in the FDA records:
"15 months from the completion of the GARDASIL HPV vaccination, I had full blown cervical cancer. My oncologist would like to do a hysterectomy at this time, but [as I have] always wanted children, I have chosen to wait . . . I have two of the [strains] that the shot is suppose to prevent . . . I now have cervical cancer and I am left wondering what role the GARDASIL HPV vaccination played in the hasty onset." (ID: 319836)
"After receiving her second dose of GARDASIL … she could crawl but … needed to use crutches or a wheel chair ... She was experienced problems breathing and had ‘super migraines' that never went away … She had swelling in her face, jaw and wrists. The patient was diagnosed with GUILLAIN-BARRE syndrome, myelin sheath degeneration and peripheral neuropathy. Patient was hospitalized twice … patient has not recovered from symptoms." (ID: 318052)
A 19-year-old girl with no medical history immediately experienced side effects after receiving the Gardasil vaccine. Within eleven days her symptoms included "Aggression, Arthralgia, Complex partial seizures, Confusional state, Convulsion, Crying, Dizziness, Epilepsy, Fatigue, Feeling abnormal, Grand mal convulsion, Immediate post-injection reaction, Irritability, Myalgia, Nausea, Pain, Postictal state, Somnolence, Syncope, Tremor, and Unresponsive to stimuli." (ID: 320598)
"Two weeks after the third dose, the patient developed a complication. She was taken to the hospital by ambulance but passed away during the transport from an unknown cause…Upon arrival in ER unresponsive, pupils fixed and dilated, no cardiac activity. Resuscitation unsuccessful and patient expired." (ID: 314769)
"The FDA is supposed to be a guardian of public health, and yet the agency continues to turn a blind eye to what seems to be an extremely serious public health problem. The public relations push for Gardasil by Merck, politicians and public health officials needs to pause so that these adverse reactions can be further studied," said Judicial Watch President Tom Fitton. "The already serious problems associated with Gardasil seem to be getting worse. No one should require this vaccine for young children."
CDC and FDA downplay risks of Gardasil
Responding to concerns about Gardasil safety, the Centers for Disease Control and Prevention (CDC) notes on its website that “the HPV vaccine was studied in 5 clinical trials before it was licensed. There were over 21,000 girls and women ages 9 through 26 in these clinical trials.” CDC states that more than 24 million doses of Gardasil were distributed in the United States as of May 1, 2009, with 13,758 VAERS reports of adverse events.
CDC also notes that it and the FDA have been “closely monitoring” the safety of Gardasil through three systems.
The main system of tracking Gardasil outcomes is VAERS, a “passive” system of data collection managed by the CDC and FDA. Anyone can submit reports of an “adverse event” or side effect online or by downloading a form. The website states that someone working with the VAERS system may contact the person or their health care provider for additional follow-up information.
While most reports on Gardasil appear to have been submitted by registered nurses or other clinical staff, one parent of a 20-year-old woman who died Nov. 15, 2008 submitted this report on Jan. 15, 2009:
“My daughter had her 3rd GARDASIL vaccine in Sept. She was a very healthy young lady, she went to take a shower and died. Autopsy report states undetermined death. There was no sign of the body to indicate a fall. She had pointed the shower head away from her and she got down on her knees and put her hand on the edge of the tub and passed away. This has been a living nightmare for her family. She is not the only one to have had problems and death from this vaccine. Please I beg you to take it off until it can be further tested. –not tested long enough to begin with.- There will be others that will die if the cause is not found.”
The CDC and FDA continue to recommend Gardasil injections.The CDC recommends the HPV vaccine be given systematically to all girls 11 and 12 years old, or before engaging in sexual activity, and to girls and women 13 through 26 years of age who did not receive it when they were younger. The vaccine is given in a series of three injections over a six-month period.
“Based on all of the information we have today, CDC continues to recommend Gardasil vaccination for the prevention of 4 types of HPV,” states the CDC website. “As with all approved vaccines, CDC and FDA will continue to closely monitor the safety of Gardasil. Any problems detected with this vaccine will be reported to health officials, healthcare providers, and the public, and needed action will be taken to ensure the public's health and safety.”
Merck has actively promoted Gardasil through TV ads aimed at the public and through Congressional lobbying. Several state legislatures have attempted to enact mandatory Gardasil vaccinations for adolescent girls. As of March of 2009, 12 states have proposed HPV-related legislation or resolutions, according to the National Conference of State Legislatures.
Merck is also seeking the FDA’s approval of Gardasil for the inoculation of boys and older women. Gardasil sales reached $1.5 billion in 2007.
Resources:
Judicial Watch Special Report: Examining the FDA's HPV Vaccine Records - June 30, 2008
Examining the FDA's HPV Vaccine Records - Appendices - June 30, 2008
Vaccine Adverse Effects Report System (VAERS) cumulative deaths report - June 16, 2009
HPV Vaccine, National Council of State Legislatures
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