Perry and Gardasil: Safe, Proven, Effective, Legitimate

The last Republican debate, the CNN/Tea Party/Strange Bedfellow event in Tampa, Florida last Monday, brought up an opportunity for Michele Bachmann (in particular) and Rick Santorum to add to the assault on front-runner Rick Perry, on the topic of his attempt in 2007 to add a drug called Gardasil to the mix of standard inoculations for school-age children.  Gardasil has been shown to be particularly effective in preventing Human Papilloma Virus (HPV), a leading cause of cervical cancer and the second most common form of cancer in women.

I addressed the debate performance aspects previously, but I want to also add to the topic in terms of the technical aspects of the Gardasil vaccination, since Bachmann has opened the can of worms of the ‘vaccines are poison’ and/or the ‘vaccines are a government plot’ conspiracy theories, a variation on the ‘fluoride weakens your bodily essence and is a communist plot’ meme of the John Birch Society from the 1950s and 60s – and beyond.  (Bachmann’s stated opposition, including trying to validate a (shall we say) 'unsubstantiated' claim of Gardasil-induced mental retardation, apparently saved Ron Paul the trouble.)

Gardasil, developed by Merck & Company, passed the rigorous testing of the FDA (some would say too slow) and was approved in June 2006, and recommended, along with the Advisory Committee on Immunization Practices (ACIP) and the Center for Disease Control & Prevention (CDC), vaccination in females aged 11 and 12 nation-wide, before they became sexually active (since it is not effective against an existing infection).  The New England Journal of Medicine stated in 2007 that:

Gardasil was nearly 100 percent effective in preventing precancerous cervical lesions caused by the strains that Gardasil protects against.  (It provides protection against two strains known to cause 70 percent of all cervical cancers and two strains known to cause 90 percent of all warts.)  Future I studies found that Gardasil is also highly effective in preventing precancerous lesions that occur on or in the vagina, anus, and vulva.  Gardasil's effectiveness increased when given to girls and young women before they become sexually active.  Gardasil is less effective in preventing precancerous lesions in women already exposed to HPV strains 16 and 18, since you cannot vaccinate against an infection that is already present.

To that end, Governor Perry issued an executive order in 2007 to add Gardasil to the list of standard inoculations of schoolchildren in Texas, and mandated all Texas girls be vaccinated prior to admission to the sixth grade, and allowed parents to opt out of the inoculation for religious or philosophical reasons.  The Texas state legislature objected to the governor’s mandate (in lieu of legislative discussion), and overturned the order by a veto-proof margin.  Perry subsequently issued another mandate to rescind his previous one, and has spoken repeatedly on his procedural mistake:

I signed an executive order that allowed for an opt-out, but the fact of the matter is I didn’t do my research well enough to understand that we needed to have a substantial conversation with our citizenry.  I hate cancer.  Let me tell you, as a son who has a mother and father who are both cancer survivors. . . . And this HPV, we were seeing young ladies die at an early age.  What we should have done was a program that frankly should have allowed them to opt in, or some type of program like that, but here’s what I learned – when you get too far out in front of the parade they will let you know.  And that’s exactly what our legislature did.

A principal reason for his action for making it mandatory is that, besides the life-saving issue, insurance companies would not cover the total $360 cost (in three injections) if it were optional.

Much has been (and is being) said about some kind of cronyism in the action (note: Merck had no competition for this drug.), but I would refer you to an article in Politico by Ben Smith, reporting on his Freedom of Information Act (FOIA) request for some 700 pages of e-mails on the subject – there was no evidence of Merck trying to affect the process and they found that Perry was “largely absent from the internal discussions”.  This would likely include the allegation that his former Chief of Staff, Mark Toomey, was instrumental in the decision.

Instead, it is likely that Perry’s wife Anita had some influence.  She has an MS degree in Nursing from the University of Texas and 17 years experience in surgery, pediatrics, intensive care, administration, teaching, and as a consultant.  She was also a keynote speaker at the Women in Government conference in 2005 on the subject of cervical cancer prevention and elimination.

As of this month, the National Conference of State Legislatures reports that 41 states and DC have enacted legislation to require, fund, or educate the public about the HPV vaccine and cervical cancer, and 20 states have enacted it, including Texas.

(H/T to Pesky Truth)

*****
Update:  This CNN report of 25 October 2011 has the CDC now recommending that young boys be vaccinated against HPV, using Gardasil or the newer Cervarix.

Additionally, Perry's action in mandating the Gardasil inoculation in 2006 was partially the result of the fact that the state would have to wait for over a year to obtain legislative agreement, since the Texas state legislature meets for only 140 days every two years.

On a related note, Michele Bachmann's home state of Minnesota requires a series of vaccinations in children, starting from infancy and continuing throughout school years, against Hepatitis B infection.  Hepatitis B is most commonly spread through sexual contact.