HPV Vaccine for Boys

Today, the American Academy of Pediatrics recommended that boys in the US be immunized against human papillomavirus (HPV) beginning at age 11-12, just as they had previously recommended for girls.  The recommendation is to use Gardasil, the vaccine produced by Merck.  It should cost about $360 per person for the 3-dose schedule, not including fees for clinic visits.

By protecting against infection with HPV types 16 and 18, which are associated with development of cervical, penile, and anal cancers (and have been reported in conjunction with some oral cancers), Gardasil is meant to be a cancer vaccine.

What does this mean for people in poor countries — where cervical and penile cancer are much more common than in the US, but the vaccine at American prices would be prohibitively expensive?  There are an estimated 500,000 new cases of cervical cancer worldwide, of which only about 12,000 (2.4%) are in the US.  Penile and oral cancer are even rarer here.

So is Merck using the world burden of cancer as an excuse to sell vaccine that the people who need it — primarily women in poor countries — won’t be able to afford?

Merck has begun an initiative to make Gardasil available in the rest of the world.  They say they will donate 3 million doses of the vaccine (enough to immunize a million people — about 2 years’ worth of new infections) over the next 5 years.  Some of this will be done through the Global Vaccine Initiative, GAVI.

  1. Marina Erlikh said:

    A clinical trial of Gardasil had been conducted on healthy females ages 9-26 living in sub-Saharan Africa (Link: http://clinicaltrials.gov/ct2/show/NCT01245764). This suggests that Merck had some intention to sell or distribute (as part of a charitable initiative) Gardasil in this region of the world. After reviewing the details of the clinical trial, I do not see any obvious ethical concerns with the way it was conducted; it was a double-blind, randomized experiment. My questions revolve around Merck’s motive for conducting a Gardasil clinical trial in this region when they know that the vaccine,as it is currently priced, is cost-prohibitive to most Africans.

    According to a business wire Merck financial analysis, worldwide Gardasil sales in 2011 were $1.2 billion, an increase of 22 percent from 2010, largely due to the increased vaccination of males ages 9-26.(Link: http://www.businesswire.com/news/home/20120202005728/en/Merck-Announces-Full-Year-Fourth-Quarter-2011-Financial-Results).

    Do Merck’s exorbitant profits obligate them to increase access to cancer vaccines like Gardasil and support greater initiatives to deliver the vaccine to people in poor countries at little or no cost? Does conducting a clinical trial in sub-Saharan Africa (that helps the development of the vaccine) award those participants with free access to the vaccine?

  2. noakrawczyk said:

    I don’t really see the problem as being Merck using the world burden of cancer as an excuse to sell vaccines that poor people won’t be able to afford. It is not as if Merck is spreading the cancer just to profit off of it, even if it might be taking advantage of the fact that it can. Even if the burden of cervical cancer in the US is only minimal compared to other regions, it is still a problem and the vaccine could be beneficial in preventing further infection. I still think the problem really lies with the pricing of drugs and making the drugs affordable for people in different economies. If Merck really goes through with an initiative to make Gardasil available through donations I think it will make the expensive prices of the vaccine in the US more acceptable since it will somewhat be balancing the costs.

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