Monday, November 15, 2010

FDA Should Expand HPV Vaccines' Age Limit

The next few months will be a very significant time, not only for women but for the Gardasil vaccine as well. This is because the FDA (Food and Drug Administration) is holding hearings into whether or not to extend the use of the vaccine. Currently, Gardasil is approved for administration between the ages of nine and twenty-six. When all is said and done, that high age range will be extended to forty-five.

Gardasil is administered in three doses with the cost hovering around $350 for the series. You can often find a physician who is willing to administer the vaccine “off label”, meaning outside of the standard protocol. As a result, the patient ends up having to carry the cost. So why would anyone really care?

Ultimately having girls immunized prior to the onset of sexual activity would be optimal but what about the teenagers and women in their early twenties, the ones who have the highest incidence of HPV infection? Their immunizations would require knowledge of the vaccine in addition to the ability to cover the expense (although Merck does provide financial assistance under certain criteria). Until age twenty-six, insurance would continue to pick up the cost of the vaccine.

So what then becomes of those women over age 26? The highest incidence of cervical cancer occurs in a woman’s thirties and forties. Presumably she has been exposed to the virus for some time, at this point, and if she continues to remain HPV positive (persistent infection), carries a much higher chance of developing cancer. By this point in time, if a woman is going to have HPV she would have shown symptoms by now, say some. Not necessarily. Symptoms of high risk HPV are often so minimal that they are missed or attributed to something else. Because many of the initial signs resolve rather quickly, the woman usually doesn’t give it a second thought.

It is important that the FDA decide to extend the use of Gardasil beyond age twenty-six to the proposed forty-five. A vast majority of women are married and have had children. They no longer need to be concerned that a pregnancy may set off an HPV infection. Having been in a monogamous relationship, their chances of having acquired the human papillomavirus are less than that of those having had multiple sexual partners during that time frame. However, what happens when this couple now divorces? When after fifteen or twenty years of marriage, the woman suddenly finds herself back on the dating scene? Is she not entitled to receive the same protection from this cancer causing virus as younger women? The answer to that question is a resounding yes, and hopefully before year’s end, the FDA will agree.