If you're a regular reader here at everybodysgood, you will likely know that anal health and preventing anal cancer for gay/bi/queer men (& for ALL women) is an issue we feel passionately about. Most recently we invited Terry Schwartz, a friend and colleague of ours (and a leader in the field of screening & treatment of anal HPV), to write a blog for us about the connection between HPV and anal cancer...and about the ongoing discussion of whether or not Gardasil, a vaccine against HPV that has been available to young women for several years to prevent cervical cancer, could or should be approved to prevent anal cancer----both in women AND in young men (especially gay/bi/queer men). While this question would seem an easy one to answer---of course we should be doing whatever we can to protect against anal cancer(s)---the truth is that the road to FDA approval ended up having more speed bumps than many would have hoped...
...until today!
This morning I arrived at work and had the following press release in my email inbox from another colleague who does a great deal of advocacy work around anal health. This is great news and a step forward in keeping all people, but especially gay/bi/queer men, healthier!!
FDA APPROVES HPV VAX TO PREVENT ANAL CANCER
WASHINGTON -- The FDA has approved the human papillomavirus vaccine Gardasil for use in males and females ages 9 to 26 to prevent anal cancer.
The decision follows a recommendation from the FDA's advisory committee on vaccines, which voted last month that the vaccine -- already approved for preventing cervical and vaginal cancer in women and genital warts in both sexes -- is safe and effective for anal cancer prevention.
A randomized trial that included men who have sex with men, ages 16 to 26, was the main basis for the new approval. It found that Gardasil was 78% effective in preventing anal intraepithelial neoplasia related to the HPV-16 and HPV-18 viral serotypes. Because the disease process of anal cancer is believed to be the same in females as in males, and because neoplasias usually develop during adulthood, the FDA did not require separate studies in females or in preteens.
The FDA emphasized that HPV vaccination would not prevent anal cancer in individuals already infected with the virus. "Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation, or chemotherapy that individuals need to endure," according to Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research, in a statement.
Although anal cancer is uncommon in the general population, the incidence is increasing, the agency indicated. About 90% of anal cancers are believed to stem from HPV infection. The American Cancer Society estimates that about 5,300 people are dianosed with anal cancer each year in the U.S., affecting more women than men
This sounds great! I'm glad that it got approval so quickly. Will there be a delay in the time it takes for implementation? and is there any idea about the associated costs of the vaccine?
Sean---That is an excellent question....and one I do not have the answer to myself. I am going to reach out to Terry and ask her if she'd post a response for you here.
In the interim, I do know that FDA approval is not the only step in the process AND that FDA approval is not the only factor in determining insurance coverage, etc. (For example, I recall that when Gardasil first got its FDA approval for use in boys to prevent genital warts, it did NOT get backed by the CDC as standard of care for boys because it was deemed not "cost effective" to vaccinate all boys. This led to a situation where the injections were AVAILABLE to boys....but not always COVERED.)
Hopefully Terry Schwartz or Craig Durie will be able to shed some light on the subject----so keep checking back here for more info!
~Erik
You are correct, Erik. Just because the FDA says that a vaccine is safe and effective for preventing anal cancer, does not mean that insurers will cover the cost. But since there is now data that the vaccine IS cost effective for (at least) "high risk" people, it is likely that the CDC will reconsider the "permissive" recommendation that it gave Gardasil when it was "only" indicated for the prevention of genital warts in boys/men.
Vaccination consists of three injections in the arm, with each injection costing about $150.00, including the administration fees charged by medical practices. I think it's an excellent investment in the sexual health of any male or female, especially those not yet infected with HPV. But not having HPV is not a criteria for administration, so anyone is a candidate for getting vacinated.
This would be a good time for any male interested in receiving Gardasil to call their insurance carrier and ask if the cost of the vaccination series is covered. And if not, tell them you don't think that's fair. Ask. Tell.
Terry Schwartz, NP
Thanks for the great info, Terry! I knew you'd have the answers!
I also love the idea of encouraging young men to ask their providers and their insurance providers about access & coverage----as a community we definitely need to start asking for (and sometimes even demanding) the kind of healthcare we deserve.
Thanks so much for the additional info!
You're welcome Sean!
FYI, for anyone who is reading this who has already been sexually active and did not first receive the Gardasil vaccine, I would recommend that you consider seeking medical evaluation for the changes in the anal canal (precancer or warts) that HPV can cause.
Anal cancer can be prevented!