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Gardasil and the GOP



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More than an hour into last night’s debate, Rep. Michele Bachmann attacked Gov. Rick Perry on the HPV vaccination controversy — or more accurately pseudo-controversy. It stems from an executive order issued by Perry in 2007 that required all Texas girls to receive Gardasil, a vaccine against the most common strains of human papilloma virus, before entering the sixth grade. However, Texas lawmakers blocked that mandate. Some critics argued that the vaccine was too new to have been confirmed safe, while others said that Perry’s order would preempt parental rights or give girls a false sense of security, possibly causing them to become sexually active at a young age.

Bachmann alluded to the Perry’s executive order mandating the exposure of young girls to a “dangerous” vaccine and tried to distinguish Gardasil from other required pediatric vaccines that prevent infectious diseases. Note to Bachmann: The vaccine, Merck’s Gardasil, prevents infection with the most common strains of human papilloma virus. Once established, these viruses can ultimately cause genital warts as well as cervical, anal, vulvar, and vaginal cancers. Thus, by preventing the infection, the vaccine prevents all those sequelae.

In the extensive clinical studies (on more than 20,000 girls and women) that were performed prior to the FDA’s licensing of the vaccine, the vaccine was 100 percent effective, a virtually unprecedented result. How safe is the vaccine? No serious side effects were detected; the most common side effect is soreness, redness and swelling in the arm at the site of the injection.

In summary, Gardasil has one of the most favorable risk-benefit ratios of any pharmaceutical.

Having spent 15 years at the FDA and having seen regulation — the good, the bad and the ugly — up close, I am as opposed to anyone (except perhaps Ron Paul) to non-essential government intrusion into our lives. But some interventions are good. Among those I would include vaccination against childhood diseases and compulsory use of seat belts and motorcycle helmets.

I am discouraged by politicians who not only don’t know much about science, technology, or medicine (which is perhaps understandable) but also don’t know what they don’t know (which is unacceptable). 

Here’s my advice to the presidential hopefuls: If you’re not sure of the facts, keep quiet.

— Henry I. Miller, M.D., is Robert Wesson Fellow in Scientific Philosophy & Public Policy Hoover Institution.



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