Documents from the Food & Drug Administration obtained by Judicial Watch under the Freedom of Information Act indicate that Gardasil, a cervical cancer vaccine manufactured by Merck that FDA officials fast-tracked for approval in 2006, may not be not as safe as its industry and government backers assured the public it was.
FDA records show that 16 new deaths (including four suicides) and 3,589 “adverse reactions” tied to Gardasil were reported in the 16 months between May 2009 and September 2010. The adverse reactions included 213 cases of permanent disability. The FDA also received 25 reports of paralyzing Guillian Barre Syndrome in young girls and women who had received the vaccine.
One 13-year-old died 37 days after receiving a Gardasil shot. “I first declined getting her the vaccination but her doctor ensured me it was safe,” the girl’s mother told the FDA.
In March, I talked to two families in Maryland and New York whose healthy, athletic, college-aged daughters suddenly dropped dead shortly after getting the shot. Another girl in Maryland suffered a major debilitating stroke days after receiving her second Gardasil injection in 2008.
Emily Tarsell, whose 21-year-old daughter Christina died 18 days after receiving her first Gardasil injection, accused Merck of misrepresenting her daughter’s case in the report the pharmaceutical company sent to the Vaccine Adverse Event Reporting System run by the Centers for Disease Control.
“Merck said in its VAERS report that a physician reported that my daughter had an enlarged spleen caused by a virus that was life threatening,” Tarsell told The Examiner. “That was totally made up. The autopsy report listed the cause of her death as ‘undetermined,’ a followup by CDC found no evidence of a viral infection, and the pathologist and her doctors all denied telling them that.”
Earlier this year, Tarsell sent out a 10-page questionnaire to 39 patients (or their families) who had experienced adverse affects following a Gardasil injection. The answers, she says, showed a pattern. “In every case, there was an increase in non pre-existing symptoms that got worse and accelerated with each additional Gardasil injection.”
Six of the 39 respondents died. All six had complained of chronic fatigue, combined with various combinations of dizziness, headaches, skin disorders and other symptoms. Statistician James Garrett found that the timing of the deaths (five after the third shot) could not be coincidental, concluding that “…the hypothesis that Gardasil is not related to any of [the six deaths] is not tenable.”
The vaccine, which protects against the human papilloma virus, is currently required for all sixth-grade girls in D.C., Maryland and Virginia, as well as many other states. Parents may opt out, but few are aware of the risks.
“A woman’s risk of dying from cervical cancer is very low if she gets annual pap smears,” Tarsell says, warning other parents: “No one tells you that if you get these symptoms, stop the injections. If we had been told, we would have declined the shot, because the risk is not worth it.”