Wednesday, January 19, 2011

FDA Approves Gardasil to Prevent Anal Cancer!

When Merck released the Gardasil vaccine it was initially touted as the preventative for cervical cancer. Unfortunately all these years later this is all that most people associated both the vaccine, and the virus (HPV), with.

What most people don't know, is that in the interim, the FDA approved the revision of the insert provided along with the vaccine to include protection/prevention of VIN (vulvar intraepithelial neoplasia) and VaIN (vaginal intraepithelial neoplasia). It has been a struggle to get the FDA to recommend revision yet again to include AIN/anal cancer. The FDA wanted four years of data before making such a decision something which only became available last year.

In November of last year, the FDA held hearings to determine whether or not to include anal cancer along with it's prior revisions. Luckily and thankfully, they made the right decision. Having gone through two cases of invasive anal cancer caused by HPV I have long known that if the virus strains which caused the other dysplasias/cancers could be thwarted by this vaccine that so should anal cancer. I didn't need four years of data to know that. But, the FDA being what it is seems to rush some things to market too quickly and linger too long with others. This should have been a slam dunk years ago and I seriously must question the thinking of those overseeing these decisions. They also approved Gardasil for use in boys which was another good sign.

Now, the final hurdle which remains is getting them to extend the age for which both women and men can obtain the vaccine which now tops out at 27. Many individuals married for decades may find themselves divorced and back on the dating scene. Why should they not be offered this same protection? While the decision has not been denied, it has been pushed back and is expected this summer. Let's hope they remain consistent with these prior two decisions and extend the age, which in my opinion should be open-ended and not just 45. Only time will tell.