New Gardasil Report Spurs Controversy and Call for Federal Investigation

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The National Vaccine Information Center is calling upon President Barack Obama and Congress to investigate the vaccine Gardasil. The call for a federal Gardasil investigation comes two days after a new federal report on Gardasil was released. The results of the report were published in the Journal of the American Medical Association. While most doctors appear to agree that Gardasil is effective in stopping HPV, the adverse events associated with Gardasil give many parents pause. According to ABC News,
“As of June 1, 2009, the CDC reported that over 25 million doses of Gardasil, which is recommended for women between ages 9-26, have been distributed in the U.S. and there was an average of 53.9 Vaccine Adverse Event Report System (VAERS) reports per 100,000 vaccine doses. Of these, 40 percent occurred on the day of vaccination, and 6.2 percent were serious, including 32 reports of death.”
In calling for a federal investigation of Gardasil, The National Vaccine Information Center noted the following:
• Gardasil was fast tracked and licensed by the FDA in 2006 and immediately recommended by the U.S. Centers for Disease Control and Prevention (CDC) for universal use by all young women, ages 11 to 26.
• Merck studied Gardasil side effects in only about 1200 girls 16 years old and younger and followed-up for less than two years before obtaining a license.
• Merck was not required by federal health agencies to use a true placebo in pre-licensure clinical trials. Instead, they compared Gardasil against a placebo that contained an unknown amount of aluminum, potentially masking the true reactivity of Gardasil, which also contains aluminum.
• Deaths and serious health problems experienced by participants receiving Gardasil in pre-licensure clinical trials were written off by Merck as a coincidence.
• Thousands of adverse events reported to the federal Vaccine Adverse Events Reporting System (VAERS) since Gardasil has been licensed—including deaths, serious health problems, emergency room visits, hospitalizations, and permanent injuries—have been written off by federal health agencies as a coincidence.
• Comparison of serious adverse events—such as death, stroke, blood clots, cardiac arrest, seizures, fainting, lupus, and re-challenge 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.
• 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.
Of course, the manufacturer of Gardasil, Merck doesn’t view the figures in the same fashion. Ultimately, parents contemplating Gardasil should consult the reports and speak in depth with their physician.

Eva Bleich
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