Three cheers for the FDA!

[hel_ana]

The Food and Drug Administration (FDA) today announced the approval of Gardasil, the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts due to human papillomavirus (HPV) types 6, 11, 16 and 18. The vaccine is approved for use in females 9-26 years of age. Gardasil was evaluated and approved in six months under FDA's priority review process--a process for products with potential to provide significant health benefits.

HPV is the most common sexually-transmitted infection in the United States. The Centers for Disease Control and Prevention estimates that about 6.2 million Americans become infected with genital HPV each year and that over half of all sexually active men and women become infected at some time in their lives. On average, there are 9,710 new cases of cervical cancer and 3,700 deaths attributed to it in the United States each year. Worldwide, cervical cancer is the second most common cancer in women; and is estimated to cause over 470,000 new cases and 233,000 deaths each year.

Comments

[much-ado.livejournal.com]

*sigh*

i know it's a first step, but what about men, and what about women beyond that age range who still show clear on emerging HPV tests (now included as part of the standard PAP workup, at least in Canada)??

[hel_ana]

According to the FDA press release, Merck is still doing tests on the drug in men.

I don't know about in Canada, but here I'm given to understand that once it's approved, it can be given to people outside that age range "off-label". ("Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects. Use of a marketed product in this manner when the intent is the "practice of medicine" does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB). However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight.")

I'm certainly going to discuss it with my doctor, to determine whether or not I've already been exposed to the relevant HPV strains, and if not, whether I can get the vaccine.

Of course, since if it's off-label, i would assume that insurance isn't going to cover it.

[hel_ana]

Some quick research online indicates that, at least in january 05, off-label prescribing was legal in Ontario.

[much-ado.livejournal.com]

Gardasil currently isn't legal in canada, which doesn't surprise me. for drugs developed in the US, we typically lag behind by a random number of months at best, and years at worst.

now i need to find out how to go about getting someone in buffalo, or even syracuse, to prescribe it for me...