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Gardasil Is a Controversial HPV Vaccine-Here’s Why

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

Gardasil, manufactured by Merck, is a controversial vaccine manufactured to prevent cervical cancer arising from the transmission of certain types of human papillomavirus.  Merck aggressively marketed Gardasil as a vaccine that could prevent cervical cancer.  The quadrivalent Gardasil was initially approved by the FDA in 2006 after being fast tracked for approval in the short span of six months.

We believe vaccines are an important facet of public health and safety.  However, some vaccines may be over-promoted or the manufacturer misleads the public as to their efficacy.  In terms of Gardasil, there are specific reasons the public should be wary.  In addition to the viral component (adjuvants), Gardasil contains ingredients that may cause adverse reactions.  These include:

  • Amorphous aluminum hydroxyphosphate sulfate (AAHS)
  • Polysorbate 80
  • Sodium borate (borax)
  • L-histidine
  • Genetically modified yeast protein
  • Undisclosed HPV DNA fragment

The other primary problem with Gardasil concerns its efficacy.  The evidence that it is an effective vaccine preventing cervical cancer is astoundingly weak.  The target age for inoculation is between 11 to 12 years old, but the median age of death by cervical cancer is 58 in the US and the cervical cancer death rate is 2.3 per 100,000. It takes 15 to 30 years for infection with HPV to lead to cancer. With such a low death rate and the decades it takes for cancer to develop, it would take an impossibly large population of patients to reach any statistically significant result in a study to show whether Gardasil prevents cancer.

The authors of a 2008 study published in Lancet Oncology estimated that, for women who received adequate treatment, including treatment for recurrent disease, the 30-year risk of cervical cancer in women diagnosed with CIN3 was 0.7%. In other words, in 30 years, 7 out of 1,000 women with CIN3 would get cervical cancer.

Researchers at the National Institute for Public Health and the Environment in the Netherlands estimated that the median time from CIN2/3 to cervical cancer was 23.5 years, with only 1.6% of lesions progressing to cancer within the first 10 years. According to the Cleveland Clinic, treatment of CIN2 and CIN3 lesions is 90% successful and reduces the risk of cervical cancer by 95% for 8 years.) In short, with proper screening, cervical cancer is almost entirely preventable.

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