Please help me make sense of Gardasil for myself at the age of 39. - Page 2

[Ldavis24]

Originally Posted by GoBecGo 

Surely it's not that it's "safe", it's that the risks of adverse vaccine reaction were outweighed by the benefits of the vaccine for younger women who were less likely to have already been exposed to the strains of HPV which Gardisil aims to protect against.  If one has already been exposed to those strains of HPV there are no benefits to the vaccine, making it purely a risk.

fair point!
 

[Sol_y_Paz]

Cancer linked HPV is not the same as genital warts HPV.   

[GoBecGo]

Arguably the presence of a strain which causes warts is indication of the presence of silent strains too.  When i was younger i "found out" a partner had once had warts.  Knowing it was a "forever" type virus and that my mother had cervical cancer (which killed her BUT it was one of the rare forms which ISN'T caused by HPV) i went to a GUM clinic in a terrible state.  There the gynaecologist gave me a cup of tea and told me that HPV is so incredibly common they assume every sexually active person, whether they used condoms or not, to have been exposed to one or other of the strains.  

[cattmom]

Just to clarify from some of the posts, there are more than 150 identified strains of HPV. Many - perhaps 30? - strains can cause genital warts. More than a dozen can lead to cancer.

Gardasil offers some protection against  two that cause 90 percent of genital warts and two others that cause cancer.  (Strains 6, 11 cause most genital warts, 16 and 18 cause 70 percent of cervical cancer).

Cervarix protects against five strains that cause cancer, but not against any genital wart strains (cancer strains 16, 18. 31. 33. 45).

The reason that the FDA did not approve Gardasil in older women is NOT because it was shown to be unsafe in older women, but because the maker could not prove that it was effective in preventing "cervical disease" -- that is, the lesions that can lead to cancer - in older women. (Interestingly, I think some research shows that older women are better at clearing HPV infections than younger women, but don't quote me on that) I believe Merck, the manufacturer, submitted a different set of evidence to the FDA in 2009 or 2010 about whether Gardasil could prevent genital warts in older women, but I don't know what that showed. I imagine that Merck thought it demonstrated effectiveness, but if that were the case, you'd think they would have gotten an approval for use on that basis.

In any case, you'd have to talk to your doctor about whether s/he would give you Gardisil at your age. You probably realize that it takes three injections over six months, and it costs several hundred dollars. 

Although genital warts are harmless, they are ugly and contagious, and I'm sure you'd like to make every effort to avoid catching them, even from a loving and stable partner. A very long period of abstinence (18 months, I'd say), followed by STD testing, is probably good advice for any modern couple that wants a safe way to be together.

[cattmom]

And I should elaborate... from what I've read, it takes months for an average healthy man to clear an HPV infection. According to research reported in this U.S. News article, it's an average of 7.5 months, but it could be as long as 24 months.

http://www.usnews.com/science/articles/2011/03/01/half-of-adult-males-carry-hpv

[cattmom]

Well, isn't this interesting. HealthCanada has just approved Gardasil for women up to 45. Maybe there's more than one way to look at the data?

http://www.torontosun.com/2011/04/26/health-canada-approves-hpv-vaccine-for-women-up-to-age-45

[Marnica]

interesting article since we are discussing the risks vs benefits of gardasil

http://sanevax.org/news-blog/wp-content/uploads/2011/02/Gardasil-vaccination-risks-vs-benefits-FINAL11.pdf

Clinical trials on Gardasil have been largely inadequate, the efficacy of the vaccine in preventing cervical cancer has not been demonstrated, the benefits of vaccination have been exaggerated and safety concerns downplayed, thus preventing parents from making informed decisions for their children. Routine immunization against cervical cancer with Gardasil is not supported by the current data. The benefit of vaccination is uncertain and the risks of serious adverse effects are substantial.

[cattmom]

Some elaboration on the Canadian view: http://www.montrealgazette.com/health/Debate+renewed+over+Gardasil+vaccine/4680027/story.html

Here's what Merck is claiming for older women: "In a study commissioned by Merck in women 24 to 45 years old, Gardasil was reported to be almost 89 per cent effective against HPV infections that can lead to cervical cancer."

Although if that's true, why did the FDA go the other way? I haven't seen anything that says.

[Marnica]

Originally Posted by cattmom 

Some elaboration on the Canadian view: http://www.montrealgazette.com/health/Debate+renewed+over+Gardasil+vaccine/4680027/story.html

Here's what Merck is claiming for older women: "In a study commissioned by Merck in women 24 to 45 years old, Gardasil was reported to be almost 89 per cent effective against HPV infections that can lead to cervical cancer."

Although if that's true, why did the FDA go the other way? I haven't seen anything that says.

Who knows, but perhaps this should be a concern, especially for women in this age group who very well may have already been infected with these strains in their lifetime.

 

In fact, according to Merck‟s VRBPAC Background Document on Gardasil HPV Quadrivalent Vaccine, the manufacturer expressed "concern" regarding the administration of Gardasil to girls who are already affected with HPV strains 16 and 18. Merck indicated that if the cervical cancer vaccine was administered to such girls, it would increase their risk of developing cervical cancer by 44.6 % (page 13, VRBPAC 8). Despite this warning by Merck, no screening is being done to rule out the presence of strain 16 or 18 of the HPV in girls before vaccination.

[Anna2011]

US seems to follow the same trend, still a bit slow and less convinced.

April 5th, 2011 they approved ""to include information on women 27 through 45 years of age in the Package Insert."" Follow the FDA link bellow.

http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm251025.htm 

This doesn't mean much yet, but at least they agree on informing the public about the results of clinical trials and the benefits of the vaccine in the age group 27-45 as well as the risks.

[Anna2011]

And lets not forget this a matter of budget as well. Maybe...somebody ..would like to delay approving a medicine that once on the "okay list" has to be accounted, budgeted and paid for. If this doesn't prove to be cost efficient than..well..we can always find some arguments of why the vaccine should not be used.

Just a thought.