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HPV Vaccine Controversy Continues

Johns Hopkins University
By Simeon Margolis, M.D., Ph.D. - Posted on Wed, Mar 21, 2007, 10:23 am PDT

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In June 2006, the FDA approved a human papillomavirus (HPV) vaccine for women between the ages of 9 and 25. The vaccine — made by Merck and marketed as Gardisil — is almost 100 percent effective in preventing four types of HPV infection: types 6 and 11, which cause genital warts, and types 16 and 18, which cause 70 percent of cervical cancers. Each year, nearly 10,000 women in the United States are diagnosed with cervical cancer and about 3,700 die of the malignancy.
 
The FDA recommendation to use the vaccine in 11- and 12-year-old girls seemed like a no-brainer. However, a number of factors have hindered the smooth implementation of routine vaccinations with Gardisil. For one, Merck showed unusual greed, even for a pharmaceutical company, by launching a heavy-handed advertising and lobbying campaign aimed at pressuring legislators to quickly pass state laws mandating school vaccination with Gardisil.

Presumably, visions of huge profits danced in the heads of Merck executives: The three-shot vaccination regimen would cost about $400, so billions could be made from required vaccination of millions of young girls — but only if Gardisil were widely adopted before approval of a similar vaccine in development by a competitor. 

Merck has now stopped these clumsy maneuvers, but not before they raised the hackles of people troubled by the increasingly intrusive actions of pharmaceutical companies. And concerns increased even more when the governor of Texas issued an executive order requiring the vaccine in schools, and it was then learned that his former chief of staff was a Merck lobbyist.

Opposition has also come from conservative groups, who argue that immunizing pre-teens against HPV would encourage sexual activity, and from those who are against all vaccines or health dictates by the state.

Legislatures in a number of states have introduced bills that would include Gardisil with other required school vaccinations. As of now, however, it is unclear whether any of these bills will pass. In fact, a Texas state senator announced plans to introduce legislation to reverse the executive order issued by the Texas governor. 

I'm not sure whether Gardisil vaccination should be required by schools, but the ideal time to vaccinate girls is before the beginning of sexual activity, in order to protect them effectively against cervical cancer. If I had pre-pubertal daughters, I would certainly want them to get the vaccine.  

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