Monday, February 25, 2008

Is GARDASIL® a responsible mandate?

If the common goals between the public and the pharmaceutical giant Merck in the controversy over compulsory HPV vaccination were long-term cost containment and public safety by reduction and prevention of widespread disease (HPV and cervical cancer, in this case), and GARDASIL is supposed to achieve both objectives; then, mandatory GARDASIL vaccinations for young women is worth investigating.


Compulsory HPV vaccination for girls before they become sexually active is said to cut long-term costs in their healthcare (especially costs related to cervical cancer). However, these costs may be outweighed by long-term costs that are unknown at this time. According to Merck's website, GARDASIL has only been tested for over a decade, which is not sufficient in considering the long-term effects of a drug on a young woman's reproductive system. Currently, GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity... it is not known whether GARDASIL can affect reproductive capacity (Merck 2007). Because a little over a decade is arguably insufficient time to recognize all of the implications that the drug may have on a woman of childbearing age who received the vaccine prior to, or during puberty, we do not know the long-term costs of what may result from the use of GARDASIL. And, we cannot assume that GARDASIL is cost efficient. We cannot consider this vaccine to be an effective one in reducing or preventing long-term, perhaps costly health problems.


As the second most common cause of cancer death in women worldwide, resulting in nearly a half-million diagnoses and 240,000 deaths each year (Merck 2007), and because 6 million people in this country become infected with HPV every year, and nearly 10,000 women are diagnosed with cervical cancer (Colgrove 2006), HPV and cervical cancer are undeniably very serious threats to public health. Compulsory HPV vaccination for girls before they become sexually active is said to significantly reduce or even prevent widespread cervical cancer. Because there is some evidence of its success in preventing four types of HPV, two of which are leading causes of cervical cancer, the fact that there are at least short-term benefits to GARDASIL is undeniable. However, the vaccine should be made accessible without mandating its use. From a moral standpoint, it seems that the use of the GARDASIL should be accessible at least for those at high risk (i.e., with family history of cervical cancer, etc.). Without long-term evidence of its efficacy and safety, it seems irresponsible (on the part of government, as well as Merck) to mandate its use, but also to deny its access completely.


The best possibility at this point is to wait until further, more conclusive and long-term research has been conducted. Given more time, competition will likely increase, which will inevitably reduce the cost to the consumer (or government), as well as provide more sound evidence regarding its long-term efficacy and safety.


References:


Merck. 2007. CDC Finalizes Advisory Panel Recommendations for GARDASIL®, Merck Cervical Cancer Vaccine. http://www.merck.com/newsroom/press_releases/product/2007_0322.html (accessed September 25, 2007).


Colgrove, J. 2006. The Ethics and Politics of Compulsory HPV Vaccination. http://www.natap.org/2006/newsUpdates/121106_05.htm (accessed February 20, 2008).

1 comment:

Rachel said...

I mentioned this at my place, but thought I'd share it here as well. You raise good points, about long-term effects, the unknowns with regard to cost effectiveness over time, and expected competing vaccines that would allow for more choice. My only comment is that it’s difficult to make such an expensive vaccine accessible without requiring it - many states and counties will provide additional financial assistance when a vaccine is mandated. Counterintuitively, mandating a vaccine (with generous opt out provisions) make actually give many people more choice with regards to the >$300 shot series than not doing so, because it would help make it affordable through county health departments. Of course, this could be circumvented by providing assistance for all vaccines regardless of school entry requirements.