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Gardasil vaccine was fast tracked and licensed by the Food and Drug Administration (FDA) in 2006 and immediately recommended by the Centers for Disease Control (CDC) for universal use by all 11-12 year old girls, teenagers and young women to age 26; and
· Merck, the drug company marketing Gardasil, was required by federal health agencies to study Gardasil side effects in only about 1200 girls 16 years old and younger and follow them up for less than two years before getting a license; and
· Merck was not required by federal health agencies to use a true placebo in pre-licensure clinical trials but compared Gardasil against a placebo that contained an unknown amount of aluminum, potentially masking the true reactivity of Gardasil, which also contains aluminum; and
· The deaths and serious health problems experienced by participants receiving Gardasil in pre-licensure clinical trials were written off by Merck as a coincidence; and
· The thousands of adverse events reported to the federal Vaccine Adverse Events Reporting System (VAERS) since Gardasil has been licensed, including deaths and serious health problems involving emergency room visits, hospitalizations, and permanent injuries, have been written off by federal health agencies as a coincidence; and
· A comparison of serious adverse events, such as death, stroke, blood clots, cardiac arrest, seizures, fainting, lupus, and rechallenge cases, reported to VAERS after Gardasil vaccination and meningococcal (Menactra) vaccination reveal that these events are reported three to 30 times more frequently after Gardasil vaccination; and
· Doctors and parents are not being informed by federal agencies or Merck about all serious adverse events associated with Gardasil so steps can be taken to monitor vaccine reactions and prevent injury and death; and
· The hallmark of good government is honesty, accountability and transparency; and
· President Barack Obama and members of Congress have pledged to improve government honesty, accountability and transparency for the people of the United States;
We call on President Barack Obama, his Administration and the U.S. Congress to investigate the expedited licensing and universal use recommendation by federal health agencies that all girls aged 11-12 years old and young women up to age 26 receive three doses of Gardasil; and further
To take action to minimize the human and economic costs of Gardasil vaccination for individuals and the American public in order to protect the lives of Americans who trust the government to ensure that vaccines licensed for public use are safe, effective and necessary.
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