In the short time since my previous article about the new cervical screening device LuViva, Health Canada has approved the use of Guided Therapeutics new device for such screening. While the FDA is poised to rule by January 20, 2012 on the device’s approval within the United States, the decision to approve the device seems doubtful given the history of the United States lagging behind Canada in these areas.
Only in the fall of 2011 did the ACIP (Advisory Committee on Immunization Practices) make recommendations to the FDA to change the status of HPV immunizations for boys from approve to recommended. Canada had, earlier this year, approved the use of the Gardasil vaccine in women up to age 45, something which the FDA has continued to refuse to do.
Many women who have been married or in long-term monogamous relationships find themselves either widowed or alone and back on the dating scene. They may never have been exposed to HPV. To deny them the right to receive the vaccine simply because of their age is nothing more than discrimination.
If the FDA approves LuViva in January, one can only speculate how this will affect the decisions with respect to the cervical screening guidelines currently being reviewed for 2011 and beyond. Those guidelines call for eliminating Pap testing in those younger than age 21.
However, studies released by Guided Therapeutics, manufacturers of LuViva, indicate that women under age 20 were just as likely to develop cancer as those over age 20. This is in direct contradiction to the arguments presented to justify doing away with Paps under age 21.
The testing and procedures which women are forced to endure in dealing with both precancerous and cancerous HPV lesions can be horrific, painful and debilitating. Hopefully, if a device shown to reduce those effects exists, the FDA will do all it can to approve it.
Bonnie Diraimondo, RN is an expert in HPV, author, international speaker and freelance writer on this subject. She maintains her own organization, The HPV Support Network, as well as her website, blog and numerous other social networks.
Sources:
“Merck receives Health Canada approval for GARDASIL to treat HPV in women up to age 45." THE MEDICAL NEWS | from News-Medical.Net - Latest Medical News and Research from Around the World. N.p., n.d. Web. 14 Dec. 2011. http://www.news-medical.net/news/20110426/Merck-receives-Health-Canada-approval-for-GARDASIL-to-treat-HPV-in-women-upto-age-45.aspx
"Glaxo HPV vaccine protects women from anal cancer." canada.com – Breaking news‚ Canada‚ World‚ Weather‚ Travel‚ Video & more. N.p., n.d. Web. 14 Dec. 2011. http://www.canada.com/health/Glaxo+vaccine+protects+women+from+anal+cancer/5293939/story.html
Reviewed December 14, 2011
by Michele Blacksberg RN
Edited by Jody Smith