HPV Case Study: State Vaccination Policymaking

Instructor: Patricia Jankowski

Patricia has a BSChE. She's an experienced registered nurse who has worked in various acute care areas as well as in legal nurse consulting.

There is current concern that pharmaceutical companies may be excessively influencing legislation to promote or mandate vaccinations in school-age children. This lesson examines that issue in the specific case of the human papillomavirus vaccine.

'Did You Know? Mom? Dad?'

Imagine yourself coming home from a hard day at work one evening and sitting down in front of the television. You hit the power button, and a commercial comes on.

A young woman appears on the screen and says, ''I have cervical cancer. I got it from an infection I once had, human papillomavirus. My chances of getting it got worse as I got older. I didn't know there was something that could have prevented it if I'd gotten it when I was a girl. A vaccine! Did you know? Mom? Dad?''

You think about your 12-year-old daughter and begin to wonder how you would explain to her what human papillomavirus is, and why she would need such a vaccine. Suddenly, you feel anxious, guilty, and curious as well.

An ad like this was actually shown on prime time television. It was part of the advertising campaign by Merck, a large pharmaceutical company that markets Gardasil, the most popular vaccine for prevention of human papillomavirus. But the ad campaign wasn't all that Merck was involved in. It also very actively took its campaign to many U.S. legislators. But in marketing a new vaccine or drug, just how far should a big pharmaceutical company go?

How far should big pharma go?
Image of girl getting vaccine

Definitions and Facts

Before we try to answer that question, let's lay some groundwork with a few definitions and statistics.

What Is Human Papillomavirus?

Human papillomavirus, or HPV, is a viral infection that is transmitted through sexual contact. It is the most common sexually transmitted disease in the United States, and more than six million people develop new HPV infections each year. There are more than 100 different types of HPV, about 30 of which are transmitted sexually.

How Likely Is Cervical Cancer From HPV?

Some forms of HPV are considered high-risk in that they may later lead to the development of cervical cancer. In fact, in 99% of cervical cancer cases, HPV is also found. However, the high-risk types of HPV — type 16 and type 18 — comprise only 3.4% of all the HPV infections, and even then, contracting a high-risk type of HPV does not automatically guarantee that this will lead to cancer. Also, for about 90% of the girls or women who have an HPV infection, the infection will simply go away on its own within two years. Put together, all of these facts show that it is not really very likely that any girl with HPV will ever develop cervical cancer from it. It does happen but not that often.

What Is Lobbying? Why Does Big Pharma Do It?

Lobbying is defined by the Encyclopedia Britannica as ''any attempt by individuals or private interest groups to influence the decisions of government; in its original meaning it referred to efforts to influence the votes of legislators, generally in the lobby outside the legislative chamber.''

When large pharmaceutical companies like Merck want to market a new drug or vaccine, it's in their best interest to get legislation passed that will help sell more of the drug or vaccine. While a vaccine may have merit and be a benefit to public health in general, it's still true that getting a law passed that makes a vaccination mandatory is one of the best ways of all to make a huge profit.

Promoting Gardasil

Gardasil was the first vaccine for HPV approved by the Food and Drug Administration, or FDA, in June 2006. Immediately after this approval, Merck played an active role in helping the lobbyists. It went to work educating them in many states about the vaccine. It received a lot of assistance from an organization called Women in Government, or WIG, a national group of non-partisan women state legislators. Although WIG is a nonprofit, it received educational grant money from Merck. It also worked with the media and with various private groups to encourage the writing of laws that would make the vaccination mandatory.

A study done by some Harvard and New York researchers in which respondents from various states were interviewed about the role they felt Merck played in the promotion of Gardasil concluded that most of what Merck did was to provide information about the product to public health officials and legislators. However, HPV vaccination did become mandatory in Texas for awhile through an executive order in 2007, which was later revoked. As of 2014, legislative bills were being considered in Indiana, Kentucky, and New York to make the HPV vaccination mandatory for school-age children.

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