Do the Risks of Gardasil, Including Paralysis, Outweigh the Benefits?

Washington, DCGardasil was promised to be the holy grail for prevention of cervical cancer, precancerous or dysplastic lesions and genital warts caused by Human Papillomavirus (HPV) types 6, 11, 16 and 18 in girls and women nine through 26 years of age. Doctors have been advocating the widespread adoption of Gardasil for young women. Parents have been on the fence. There is reason for that, it appears.

Side effects of Gardasil include, but are not limited to paralysis, Guilliane-Barré Syndrome, seizures and blindness. And while the vaccine is not meant for anyone less than nine years of age, the death in New Zealand of a toddler age three has galvanized opinion surrounding Gardasil.

The Activist Post (7/18/12) highlighted the story of Chace Topperwein, a delightful 3-year-old boy who was accidently given Gardasil at the age of 6 months. Even though Gardasil is designed to prevent cancer (specifically, cervical cancer), the boy contracted a rare form of cancer and died at the tender age of three from myeloid leukemia in May.

The Activist Post noted that Gardasil manufacturer Merck did not perform tests for carcinogenicity.

What's more, the Post claims that Merck's clinical studies for Gardasil compared their cervical cancer vaccine against Amorphous Aluminum Hydroxyphosphate Sulfate or AAHS, which is an aluminum adjuvant additive. Five, out of seven tests performed by Merck on Gardasil were said to compare the vaccine against this particular additive rather than a saline placebo. The Post cites Merck's own prescribing information, which reportedly makes this admission in Section 13.

"In other words," writes the Activist Post, "Gardasil was deemed 'safe' when it was compared to an aluminum additive that is neuro-toxic. The true risks of the vaccine are unknown because both substances showed adverse reactions."

The publication also cites a document from the US Food and Drug Administration (FDA) dated May, 2006 which appears to show that females previously exposed to HPV viruses similar to those contained in Gardasil, increase the risk of developing precancerous lesions by 44.6 per cent if they take Gardasil. "Merck fails to warn about this risk," the Post says.

The concern appears to mirror similar cautions contained in the Washington Examiner (2/21/12), which referenced a recent Canadian study authored by Lucija Tomljenovic and Christopher Shaw of the University of British Columbia’s Neural Dynamics Research Group. The study authors, according to the Examiner, rattled off a host of side effects associated with Gardasil and one other competing vaccine. Those included, "death, convulsions, paraesthesia, paralysis, Guillain–Barre syndrome, transverse myelitis, facial palsy, chronic fatigue syndrome, anaphylaxis, autoimmune disorders, deep vein thrombosis, pulmonary embolisms and cervical cancers."

State law in Texas, Virginia and the District of Columbia requires vaccination against the Human papillomavirus (HPV) for all pre-adolescent girls prior to entering sixth grade. The controversial law does leave the final word with the parents, who have the choice to either opt in and follow the law, or not. Girls who are not vaccinated are not barred from attending school nonetheless.

The controversy stems from the perceived need for such a blanket vaccination program in North America. Critics of the blanket program note that potentially life-threatening adverse reactions to Gardasil—including paralysis—outweigh the known risks for contracting HPV. "In the Western world, cervical cancer is a rare disease with mortality rates that are several times lower than the rate of reported serious adverse reactions (including deaths) from HPV vaccination," write the Canadian study authors.

They cite a lack of scientific evidence that HPV vaccines actually prevent cervical cancer. "At present there are no significant data showing that either Gardasil (Merck) or Cervarix (GlaxoSmithKline) can prevent any type of cervical cancer since the testing period employed was too short to evaluate long-term benefits of HPV vaccination," they write.

The Examiner notes that Dr. Diane Harper, a leading HPV researcher funded by Merck, has called the use of Gardasil on females under age 16 "a great big public health experiment." For families with a history of cervical cancer, an HPV vaccine may make sense. But beyond that, critics say such a program does little more than provide a boon for drug manufacturers. According to the Activist sales of Gardasil topped $1.2 billion globally last year, a 22 percent increase from 2010.

The Washington Examiner noted that a Freedom of Information Act request by advocacy group Judicial Watch revealed 26 deaths (as reported by the FDA) in the 12 months prior to September 2011. The window also included countless reports of seizures, blindness and paralysis, stemming from Gardasil.